100821-620 Cascade Elite Operator's Manual.pdf 511tg

Elite Operators Manual

Table Of Contents © 2014 Cadwell. All rights reserved. ......................................................................................... 3 Disclaimer ...................................................................................................................................... 3 Trademark Notices ....................................................................................................................... 3 Introduction................................................................................................................................... 5 Intent of Operator's Manual .................................................................................................... 5 Overview ................................................................................................................................... 5 Cascade Elite Intended Use ..................................................................................................... 8 Electrical Stimulator Guide ..................................................................................................... 8 Setup Instructions ....................................................................................................................... 11 Hardware Setup...................................................................................................................... 11 Unpacking the System ....................................................................................................... 11 Position Elite Base Unit ...................................................................................................... 12 Elite Base Unit Connections .............................................................................................. 12 Power/Com Module Connections .................................................................................... 13 Elite Cabling Setup Instructions ....................................................................................... 14 Configuring the ES-IX ........................................................................................................ 16 Peripheral Devices and Connections ............................................................................... 23 Cabling Diagram - Elite to Desktop PC ........................................................................... 24 Cabling Diagram - Elite to Laptop PC ............................................................................. 24 Cascade Elite Features & Accessories .............................................................................. 25 Mounting V-Blocks on IV Pole ......................................................................................... 29 Attach Cascade to a Jackson Table ................................................................................... 31 Printer Setup........................................................................................................................ 32 Using the Hardware Simulator ........................................................................................ 32 TCS Setup ............................................................................................................................ 33 Software Setup ........................................................................................................................ 35 Software Setup Overview.................................................................................................. 35 Software Installation Instructions .................................................................................... 35 Configuring Cascade in Windows 7 ................................................................................ 39 Activating Software Licenses ............................................................................................ 48 Creating a Shortcut to a Network Location .................................................................... 51 Minimum Computer Requirements ................................................................................ 55 Editing System Setup ............................................................................................................. 57 System Setup - Overview .................................................................................................. 57 iii

Elite Operators Manual General Tab ......................................................................................................................... 58 Remote Tab .......................................................................................................................... 60 Chat Tab ............................................................................................................................... 61 Event Filtering Tab ............................................................................................................. 62 Colors Tab ............................................................................................................................ 63 Performance/Operational Recommendations .................................................................... 64 Getting Started - The Basics ...................................................................................................... 67 The Basics................................................................................................................................. 67 Working with Basic Windows® ....................................................................................... 67 Turning Equipment On and Off ....................................................................................... 67 Opening and Closing Cascade Software ......................................................................... 68 Working with Cascade Software .......................................................................................... 68 Cascade Elite Start Page Overview .................................................................................. 68 Working with Cascade Windows..................................................................................... 70 Parts of a Window .............................................................................................................. 73 Toolbar Descriptions .......................................................................................................... 74 Global EP Window ............................................................................................................. 77 Working With Waveforms ................................................................................................ 78 Multi-Modal Stimulator Triggering ................................................................................. 79 Cascade File Extensions ..................................................................................................... 82 Cascade Data Management (DM) ............................................................................................ 85 Data Management within Cascade Application ................................................................ 85 Starting a new procedure .................................................................................................. 85 Procedural Notes ................................................................................................................ 86 Review / Append to an existing procedure .................................................................... 87 Import & Export.................................................................................................................. 88 Local Service Control .................................................................................................. 90 Starting/Running Procedures ................................................................................................... 99 Starting a Procedure ............................................................................................................... 99 TCS Stimulus Triggering ..................................................................................................... 100 TCS Stimulus Intensity Adjustment .................................................................................. 101 Charge Accumulation Recommendation .......................................................................... 102 Checking Impedance............................................................................................................ 103 To check electrode impedance ........................................................................................ 104 Averaging Waveforms ......................................................................................................... 105 Electro-Surgery Detector and Electro-Surgery Reject ..................................................... 106 iv

Table Of Contents Working with Cursors ......................................................................................................... 109 Setting Baselines ................................................................................................................... 110 Changing Settings for Multiple Modes ............................................................................. 111 Side-by-Side Comparison of Current and Past EEG ....................................................... 112 Appending to a Procedure .................................................................................................. 113 System Clock Error ............................................................................................................... 113 Exporting Data ...................................................................................................................... 114 Reducing Noise ..................................................................................................................... 115 Cascade Noise Reduction Options ................................................................................. 116 Choosing The Appropriate Repetition Rate 60 Hz ...................................................... 121 Determining Frequency of Noise ................................................................................... 129 Using Menu Options ............................................................................................................ 131 File Menu ........................................................................................................................... 131 Edit Menu .......................................................................................................................... 132 View Menu ........................................................................................................................ 133 Test Menu .......................................................................................................................... 135 Remote Menu .................................................................................................................... 135 Events Menu...................................................................................................................... 136 Window Menu .................................................................................................................. 137 Help Menu ......................................................................................................................... 138 Running NerveGuard .......................................................................................................... 139 NerveGuard Introduction ............................................................................................... 139 NerveGuard Operation.................................................................................................... 139 Determination of Threshold ............................................................................................ 140 Performing Pedicle Screw Threshold Detection .......................................................... 141 Using Continuous Stimulation Mode ............................................................................ 141 Using Fixed Detection Mode .......................................................................................... 142 Making Changes During Testing ................................................................................... 142 NerveGuard and Remote Monitoring ........................................................................... 143 NerveGuard Window ...................................................................................................... 143 Closing NerveGuard ........................................................................................................ 152 Operating the TCS ................................................................................................................ 152 Recording Transcranial Electric Motor Evoked Potentials ......................................... 153 Changing the Stimulus Parameters during a Recording ............................................ 154 Storing and Clearing Traces ............................................................................................ 162 Train Length Limit Warning ........................................................................................... 163 v

Elite Operators Manual High-Z Warning ............................................................................................................... 165 Run Mode .......................................................................................................................... 165 Artifact Reject .................................................................................................................... 165 Closing a Procedure ......................................................................................................... 167 Reviewing a Procedure ............................................................................................................ 169 Reviewing a Procedure ........................................................................................................ 169 Procedure Setup........................................................................................................................ 171 Procedure Setup - Overview ............................................................................................... 171 Procedure Setup - Channels ................................................................................................ 173 Modes ..................................................................................................................................... 177 Mode Overview ................................................................................................................ 177 MEP Mode Setup .............................................................................................................. 186 Mode Setup........................................................................................................................ 192 Mode Window Descriptions ............................................................................................... 202 Mode Windows Setup Overview ................................................................................... 202 Mode Controls .................................................................................................................. 202 EP Average Window ........................................................................................................ 203 EP Summary Window ..................................................................................................... 209 MEP Summary Window.................................................................................................. 211 MEP Analysis Window.................................................................................................... 212 EMG Window ................................................................................................................... 213 Stacked EMG Window..................................................................................................... 216 MEP Triggered Window.................................................................................................. 218 Live EEG Window ............................................................................................................ 222 EEG Analysis Window .................................................................................................... 225 3D Trend Window ............................................................................................................ 228 Cursor Trend Window..................................................................................................... 229 Video Window .................................................................................................................. 232 Event Window .................................................................................................................. 233 Waterfall Window ............................................................................................................ 235 TOF (Train of Four) Trace Window ............................................................................... 236 TOF (Train of Four) Analysis Window ......................................................................... 239 View Setup and Mode Windows Setup ............................................................................ 240 Views Overview ............................................................................................................... 240 Mode Control Window Setup......................................................................................... 241 EP Average Window Setup ............................................................................................. 242 vi

Table Of Contents EMG Window Setup ........................................................................................................ 245 MEP Window Setup ......................................................................................................... 246 Live EEG Window Setup ................................................................................................. 249 Event Window Setup ....................................................................................................... 251 Summary Window Setup ................................................................................................ 254 Waterfall Trend Window Setup ..................................................................................... 257 Show ................................................................................................................................... 259 Waveforms......................................................................................................................... 259 Cursors ............................................................................................................................... 260 Channels ............................................................................................................................ 260 EP Cursor Trend Window Setup .................................................................................... 260 Live Video Window Setup .............................................................................................. 263 EP Analysis Window Setup ............................................................................................ 264 Stacked EMG Window Setup.......................................................................................... 268 EEG Analysis Window Setup ......................................................................................... 270 TOF Window Setup.......................................................................................................... 274 TOF (Train of Four) Analysis Window Setup .............................................................. 275 3D Trend Window Setup ................................................................................................. 277 Waterfall Window ............................................................................................................ 278 Global Summary Window Setup ................................................................................... 280 Global Waterfall Window Setup .................................................................................... 282 Test Setup .............................................................................................................................. 284 Other Setup............................................................................................................................ 285 Mode Groups .................................................................................................................... 285 Mode Group Cycle ........................................................................................................... 287 NerveGuard Procedure Setup ............................................................................................ 289 Stimulators............................................................................................................................. 293 Electrical Stimulators ....................................................................................................... 293 TCS Stimulators ................................................................................................................ 295 Single-output Transcranial Stimulators (TCS-1/TCS-1000) ........................................ 296 Multiple-output Transcranial Stimulator (TCS-4) ....................................................... 298 Auditory Stimulator ......................................................................................................... 299 Visual Stimulators ............................................................................................................ 300 Paired Stimuli .................................................................................................................... 300 Cascade EEG and EEG Analysis ........................................................................................ 305 Example EEG Analysis Windows .................................................................................. 305 vii

Elite Operators Manual EEG Windows ................................................................................................................... 310 EEG Analysis Window .................................................................................................... 312 Remote Monitoring .................................................................................................................. 317 Introduction........................................................................................................................... 317 What is Remote Monitoring? .......................................................................................... 317 What can you do on the Remote Reader? ..................................................................... 317 What can't you do on the Remote Reader? ................................................................... 318 Minimum Computer Requirements* ............................................................................. 318 Connection Scenarios ........................................................................................................... 319 Remote Monitoring Connection Diagrams ................................................................... 319 Peer to Peer on a LAN...................................................................................................... 322 VPN into LAN................................................................................................................... 322 Third Party Software ........................................................................................................ 323 Setup Instructions ................................................................................................................. 323 Setup for Remote Reader ................................................................................................. 323 Peer to Peer on a LAN setup ........................................................................................... 324 VPN into LAN setup ........................................................................................................ 332 VPN to VPN setup............................................................................................................ 332 Third Party Software setup ............................................................................................. 332 Starting a Remote Monitoring Session .............................................................................. 333 Initializing a Remote Monitoring Session from the Reader ....................................... 333 Initializing a Remote Monitoring Session from the Cascade ..................................... 334 System Setup on the Remote Reader ............................................................................. 336 Chat Box ............................................................................................................................. 338 Sync with Server ............................................................................................................... 339 Views .................................................................................................................................. 339 Reports ............................................................................................................................... 341 Data Rates for Remote Monitoring ................................................................................ 343 Disconnect ......................................................................................................................... 344 Trouble Shooting .................................................................................................................. 344 Errors .................................................................................................................................. 344 Command Prompt ............................................................................................................ 347 Search for Computer ........................................................................................................ 348 Generating Reports .................................................................................................................. 349 Cascade Report Generation................................................................................................. 349 The Report Generation Process ...................................................................................... 349 viii

Table Of Contents Templates/Tokens............................................................................................................. 349 Steps for Report Generation ............................................................................................ 350 Default Report Templates ............................................................................................... 354 Report Templates and the Template Editor Program ..................................................... 355 Appearance of a Typical Template ................................................................................ 355 Opening an Existing Template ....................................................................................... 356 Template Editor ................................................................................................................ 357 Copying Templates .......................................................................................................... 358 Customizing the Appearance of the Template ............................................................. 358 Using a Page Header ........................................................................................................ 359 Customizing the Report Header..................................................................................... 361 Signatures in Reports ....................................................................................................... 362 Cascade Tokens................................................................................................................. 364 Choice Token ..................................................................................................................... 367 Inserting a Token into a Template.................................................................................. 369 Using Specialized Tokens ................................................................................................ 370 Inserting the Contents of RTF/Bitmap Files .................................................................. 379 Saving Templates.............................................................................................................. 380 Closing the Template Editor ........................................................................................... 380 Safety Information .................................................................................................................... 381 General Warnings and Precautions ................................................................................... 381 TCS Warnings and Precautions .......................................................................................... 384 Symbols .................................................................................................................................. 385 Verification of Proper Operation ........................................................................................ 387 Operating Environments & Limits..................................................................................... 388 Transportation & Storage Limits ........................................................................................ 388 Electrical Safety Requirements and Allowable Configurations ..................................... 388 Electromagnetic Compatibility ........................................................................................... 391 Disposal of Equipment ........................................................................................................ 397 TCS Specifications ................................................................................................................ 397 ES-IX Specifications .............................................................................................................. 403 Electrode Current Density Graphs..................................................................................... 403 EMG Needle ...................................................................................................................... 403 EEG Needle ....................................................................................................................... 404 Disposable Bar Electrodes ............................................................................................... 404 Bar Electrodes.................................................................................................................... 405 ix

Elite Operators Manual Felt-Pad Bar Electrodes .................................................................................................... 405 Electrical Stimulator Characteristics .............................................................................. 406 ES-IX Stimulator Characteristics .................................................................................... 407 Care and Cleaning of Equipment ........................................................................................... 413 General Cleaning .................................................................................................................. 413 Cleaning Cascade Components .......................................................................................... 413 Cleaning Stimulators............................................................................................................ 413 Cleaning Electrodes.............................................................................................................. 414 General Care of TCS Units .................................................................................................. 415 Service and Maintenance ......................................................................................................... 417 Amplifier Calibration ........................................................................................................... 417 Amplifier Diagnostics .......................................................................................................... 418 Impedance Test Arrays & Amplifier Diagnostics ............................................................ 420 ES-IX Diagnostics.................................................................................................................. 422 Routine Maintenance ........................................................................................................... 424 Archiving with Windows 7 built-in burner ...................................................................... 424 Repair ..................................................................................................................................... 427 Software Upgrades ............................................................................................................... 428 Third Party Applications ..................................................................................................... 428 Warranty & Service Contracts ............................................................................................ 429 Limited Warranty ............................................................................................................. 429 Customer .................................................................................................................... 433 Using Help Files.................................................................................................................... 433 Cascade Customer ................................................................................................. 433 Remote Assistance ................................................................................................................ 434 Shipping Equipment ............................................................................................................ 434 Approvals and Standards........................................................................................................ 437 Compliances .......................................................................................................................... 437 Domestic and International Approvals ............................................................................. 437 Frequently Asked Questions................................................................................................... 439 Some Frequently Asked Questions: ................................................................................... 439 Glossary ..................................................................................................................................... 445 Acquisition Sweep ................................................................................................................ 445 Display Sweep....................................................................................................................... 445 Act/Ref.................................................................................................................................... 445 Active Modes ........................................................................................................................ 445 x

Table Of Contents Active Window ..................................................................................................................... 445 Add/Delete/Rename View Buttons .................................................................................... 446 Add Marker ........................................................................................................................... 446 Adjust Latency ...................................................................................................................... 446 All ........................................................................................................................................... 446 All Gain Control ................................................................................................................... 446 All Manual Modes ................................................................................................................ 446 All Auto Modes..................................................................................................................... 446 Amp Chn ............................................................................................................................... 447 Amplifier................................................................................................................................ 447 Amplifier Channel Buttons ................................................................................................. 447 Amplifier Gain ...................................................................................................................... 447 Amplitude Markers .............................................................................................................. 447 As Recorded .......................................................................................................................... 447 As Recorded Gain ................................................................................................................. 447 As Recorded .......................................................................................................................... 448 Audio Controls ..................................................................................................................... 448 Auto Place Cursor On Manual ........................................................................................... 448 Auto Place Cursors ............................................................................................................... 448 Auto Position On-Off ........................................................................................................... 448 Auto Size ................................................................................................................................ 449 Auto Store On Avg Complete ............................................................................................. 449 Auto-Place Cursors on Percent of Average Complete .................................................... 449 Auto Store - (MEP) Mode .................................................................................................... 449 Baseline Trace ........................................................................................................................ 449 Cancel ..................................................................................................................................... 449 Center Marker ....................................................................................................................... 449 Center Marker on Baseline .................................................................................................. 449 Center/Range ......................................................................................................................... 450 Ch 16 Audio Mute ................................................................................................................ 450 Camera Setup ........................................................................................................................ 450 Channel Button ..................................................................................................................... 450 Channel Fields ...................................................................................................................... 450 Channel Labels ...................................................................................................................... 450 Channel Name ...................................................................................................................... 450 Channel Section .................................................................................................................... 450 xi

Elite Operators Manual Clear ....................................................................................................................................... 450 Clear Button........................................................................................................................... 450 Clear Button........................................................................................................................... 451 Clear Captured Trace ........................................................................................................... 451 Clear Cursors......................................................................................................................... 451 Client List............................................................................................................................... 451 Control Button ...................................................................................................................... 451 Copy Special .......................................................................................................................... 453 CSA ......................................................................................................................................... 453 CSA Scale ............................................................................................................................... 453 Current Procedure Setup ..................................................................................................... 453 Detection Mode ..................................................................................................................... 453 Disp Gain ............................................................................................................................... 454 Display Sweep....................................................................................................................... 454 Division Units ....................................................................................................................... 454 Dot-to-Dot Markers .............................................................................................................. 454 Dot-to-Dot/Table View ........................................................................................................ 454 DSA......................................................................................................................................... 455 DSA Colors ............................................................................................................................ 455 DSA Max Power ................................................................................................................... 455 DSA Max Voltage ................................................................................................................. 455 DSA Smoothing .................................................................................................................... 455 EEG Burst Suppression ........................................................................................................ 455 EEG Drawing Selections ...................................................................................................... 456 EMG Run Modes .................................................................................................................. 456 Enable 16 Ch Reject .............................................................................................................. 456 Enable Auto Capture on Threshold ................................................................................... 457 Enable Bovie Reject .............................................................................................................. 457 Enable Store on Threshold .................................................................................................. 457 Enable Wave/Beep ................................................................................................................ 457 EP Mode Controls................................................................................................................. 457 EP Modes ............................................................................................................................... 457 ES-5 -10 Stim Splitter ............................................................................................................ 458 Event List ............................................................................................................................... 458 Event Text .............................................................................................................................. 458 Events ..................................................................................................................................... 458 xii

Table Of Contents Feature.................................................................................................................................... 458 File Names ............................................................................................................................. 458 Freeze ..................................................................................................................................... 458 Freeze Frame ......................................................................................................................... 458 Frequency Range (Hz) ......................................................................................................... 459 Display Gain .......................................................................................................................... 459 Gain ........................................................................................................................................ 459 Grand Average...................................................................................................................... 459 Graticule................................................................................................................................. 459 HiCut, LoCut ......................................................................................................................... 459 Horizontal Trend .................................................................................................................. 459 Impedance ............................................................................................................................. 459 Intensity Bar .......................................................................................................................... 460 Insert Copy Button ............................................................................................................... 460 Invert ...................................................................................................................................... 460 Label Format ......................................................................................................................... 461 Lock Graph ............................................................................................................................ 461 Marker .................................................................................................................................... 461 Max Intensity......................................................................................................................... 461 MEP Mode ............................................................................................................................. 461 MEP Mode Controls ............................................................................................................. 461 MEP Mode Options: ............................................................................................................. 462 Minutes Labels ...................................................................................................................... 462 Mode....................................................................................................................................... 463 EMG Trace Area ................................................................................................................... 463 Print Report Button .............................................................................................................. 463 Norm Percent Change.......................................................................................................... 464 Notch/Audio ......................................................................................................................... 464 Paging Controls .................................................................................................................... 464 Pause EEG Analysis ............................................................................................................. 464 Pause Averager ..................................................................................................................... 465 Play Sound on Stim .............................................................................................................. 465 Print EEG Report .................................................................................................................. 465 Print Procedure Setup .......................................................................................................... 466 Print Screen............................................................................................................................ 466 Pulse Width 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Elite Operators Manual Refresh.................................................................................................................................... 466 Refresh Rate ........................................................................................................................... 466 Reject ...................................................................................................................................... 466 Reject Setting Dialog ............................................................................................................ 466 Remove Stim Artifact From EMG ...................................................................................... 468 Rename Window Button ..................................................................................................... 469 Resolution .............................................................................................................................. 469 Rotate/Tilt .............................................................................................................................. 469 Run.......................................................................................................................................... 469 Run Mode .............................................................................................................................. 469 Select All ................................................................................................................................ 469 Setting Baselines ................................................................................................................... 470 Set Epoch Length .................................................................................................................. 470 Setup Stim .............................................................................................................................. 470 Setup Tables .......................................................................................................................... 470 Show ....................................................................................................................................... 471 Show Baseline ....................................................................................................................... 471 Show Baseline Dot-to-Dot ................................................................................................... 471 Show Burst Suppression Info.............................................................................................. 471 Show Section (Table View):................................................................................................. 471 Show Cursors ........................................................................................................................ 472 Show Events .......................................................................................................................... 472 Show In Trace Windows...................................................................................................... 472 Show Percents ....................................................................................................................... 472 Show Trial Numbers ............................................................................................................ 472 Show Trial Numbers and Time .......................................................................................... 472 Single ...................................................................................................................................... 472 Smooth ................................................................................................................................... 473 Smooth/Unsmooth ............................................................................................................... 473 Sync with Server Button ...................................................................................................... 473 Spectral Edge ......................................................................................................................... 473 Stim Hold/Stim Rep ............................................................................................................. 473 Stim Type ............................................................................................................................... 473 Stimulate ................................................................................................................................ 473 Store ........................................................................................................................................ 473 Store ........................................................................................................................................ 474 xiv

Table Of Contents Store Image On ..................................................................................................................... 474 Suppress Audio During Stim.............................................................................................. 474 Sweep Delay .......................................................................................................................... 474 Symmetry............................................................................................................................... 474 Take Snapshot ....................................................................................................................... 474 Test.......................................................................................................................................... 474 Threshold Markers ............................................................................................................... 475 Time Bar Event Marks ......................................................................................................... 475 Timer Intervals ...................................................................................................................... 475 TOF Mode Controls.............................................................................................................. 475 Trace Labels ........................................................................................................................... 476 Trace Name ........................................................................................................................... 476 Trace Windows ..................................................................................................................... 476 Train Setup ............................................................................................................................ 476 Trend ...................................................................................................................................... 476 Trend Count .......................................................................................................................... 476 Trend ...................................................................................................................................... 477 Trend Settings ....................................................................................................................... 477 Trend Time ............................................................................................................................ 477 Trial Select ............................................................................................................................. 477 Trigger .................................................................................................................................... 477 View Selection ....................................................................................................................... 477 Voltage, Power, ZScore ........................................................................................................ 477 Waveforms ............................................................................................................................ 477 Waveforms ............................................................................................................................ 478 Window Setup Button ......................................................................................................... 478 Z Score Colors ....................................................................................................................... 478 Zoom Control ........................................................................................................................ 478 Zoom In/Zoom Out .............................................................................................................. 479 Index ........................................................................................................................................... 481

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Help File Operator's Manual

Part Number 100821-620 Rev. 8 Version 2.7

Cadwell 909 North Kellogg Street Kennewick, WA 99336, USA (+1) 509-735-6481 Fax (+1) 509-783-6503 www.cadwell.com

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Elite Operators Manual

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Cadwell Cascade Elite Operator's Manual © 2014 Cadwell. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form, by any means, electronic, mechanical, optical, chemical, manual, or otherwise without prior written consent of Cadwell.

Disclaimer Clinical conclusions and decisions based on the use of this product are the responsibility of the . The manual provides an operational summary for the Cascade Elite system. It does not provide clinical training. It is assumed that the has adequate clinical training to perform intraoperative neuromonitoring procedures. This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. Features and specifications are subject to change without notice. Cadwell does not accept any liability for the use or misuse, direct or indirect, of this product. s must accept all responsibility for any results obtained by or concluded from data obtained by the products. The must accept all responsibility for results obtained by software from Cadwell.

Lateral Transpsoas Monitoring: Cadwell’s intraoperative neurophysiological monitoring software and products are not intended for intraoperative lateral transpsoas monitoring that employs automated methods of nerve threshold detection (“ILTM applications”). Cadwell disclaims all use of its intraoperative neurophysiological monitoring software and related products for any use for ILTM applications. With the exception of Cadwell has a legal and ethical obligation to provide, Cadwell does not or provide assistance for any use of its intraoperative neurophysiological monitoring software and products for ILTM applications. The use of Cadwell’s intraoperative neurophysiological monitoring software and products for ILTM applications is not recommended and at the ’s own risk.

Trademark Notices Cadwell is a ed trademark, and Cascade™ and Cascade Elite, and Cascade PRO are trademarks of Cadwell. Other brand and product names are trademarks or ed trademarks of their respective holders. Cadwell reserves the right to modify, delete, extend, or improve features described herein without notice. 3

Elite Operators Manual

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Introduction

Introduction Intent of Operator's Manual This manual is intended as a basic guide to installing and operating your Cadwell Cascade Elite. Please refer to the following information sources for more detailed information on operating and servicing your Cadwell Cascade Elite. •

Cadwell Cascade Elite Operator's Manual. Part number 100821-620.

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Cadwell Cascade Elite Help File. Part number 369028-620. Available with installed Cascade application and at www.cadwell.com

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Cadwell Cascade Technical Manual. Part number 100820-621.

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Cadwell ES-IX Stimulator Setup Guide. Part number 190262-933.

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Configuring Cascade on Windows 7. Part number 369028-626.

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Cadwell website. www.Cadwell.com

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Cadwell Applications & Service . See Cascade Customer .

Overview Cascade Elite The Cascade Elite™ is designed for intraoperative neuromonitoring (IONM) of evoked potential (EP), transcranial electrical motor evoked potential (TceMEP), electromyography (EMG), and electroencephalogram (EEG) signals. Intraoperative neuromonitoring is a means of reducing the risk of permanent injury to neural structures during surgical procedures. Changes or abnormalities in the recorded signals may indicate that the surgical procedure is affecting the neural structure. The Cascade Elite Intraoperative Monitor measures and displays the electrical signals generated by muscles, the central nervous system and peripheral nerves. It acquires the data necessary to perform intraoperative monitoring of neural pathways to prevent damage to neural structures during surgical procedures. The Cascade Elite product, in its standard configuration, consists of a base unit, power communication module (power/com), and stimulator splitter or ES-IX stimulator(s). Software in the unit allows s to create different procedure setup files for various kinds of surgical cases. At the beginning of the surgery, the opens the configured procedure setup file to begin a recording session. Several modes are run at different intervals during the surgery, collecting data and displaying that data in different formats. The can run the modes individually or all concurrently. After surgery, the data file may be viewed remotely and the patient data file may be reviewed. Reports can also be created at the end of the surgery and/or when reviewing the data after surgery.

Components

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Elite Operators Manual

The Cadwell Cascade Elite may include the following: •

The Elite base unit houses two 16-channel amplifiers and electrical, auditory, and visual stimulators in a durable water resistant metal enclosure.

•

Four 16-input amplifier input extender cables (pods) allow you to connect up to 64 recording electrodes for use in creating up to 32 recording channels.

•

Power and communication to and from the base unit is provided by a Power Communication Module (power/com). A single power/com cable runs from the power/com module to the base unit. A standard 10base-T Ethernet cable connects the power/com module to your computer.

•

There are seven available electrical stim splitters: ES-5-100, ES-5-5, ES-5-20, ES-16, ES-5-5V, and the linkable ES5-1 STD and ES-5-2 OPT.

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The Cascade Elite can also be enabled to run the ES-IX stimulator.

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The TCS-1/TCS-1000/TCS-4 is an optional device that connects to the Cascade base unit via an auxiliary port. The TCS-1/TCS-1000/TCS-4 are constant voltage stimulators that have FDA approval for transcranial electrical stimulation for the purpose of recording motor evoked potentials. The device provides one constant voltage output, and in the case of the TCS-4, one of four channels may be selected as the active output. All of these stimulators include polarity control within the Cascade software. See below for more information.

•

There are four auditory stimulators available as optional devices for the Cascade Elite. The Insert Earphones are the most commonly used auditory stimulator for intraoperative neuromonitoring of auditory evoked potentials.

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There are four visual stimulators available as optional devices for the Cascade Elite. The VEP Goggles are the most commonly used simulator for visual evoked potentials in the operative theater.

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The ES Detector unit, attached to the base unit via one of the auxiliary ports, is designed to detect the usage of electrical noise-generating devices such as electrosurgery units. The ES Detector pauses data collection and audio output while these noise-generating devices are in use.

TCS-1/TCS-1000/TCS-4 Stimulator The Cadwell® Transcranial Stimulators (TCS-1/TCS-1000/TCS-4) are constant-voltage electrical stimulators intended for the performance of Motor Evoked Potential studies using the Cadwell Cascade® Intraoperative Surgical Monitoring System. Operation of the TCS-1/TCS-1000/TCS-4 is controlled through the Cascade system software. An auxiliary cable connects the TCS-1/TCS-1000/TCS-4 device to one of three auxiliary ports (Aux 1, 2 or 3) on the Cascade base unit. The TCS-1/TCS-1000 connects to the patient via one stimulus output pair (consisting of one red and one black DIN electrode

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Introduction jack). The TCS-4 provides the ability to connect four stimulating channels to the patient, but only one output channel can be active at any given point in time. The “normal” polarity setting delivers stimuli with the red output as anode (+) and the black output as cathode (-). The “reverse” polarity setting delivers stimuli with the red output as cathode (-) and the black output as anode (+). For the TCS-4, the anode jack of the active channel is designated by a solid lit LED. The following stimulus options are available for the TCS stimulus types: •

Stimulus polarity: Normal or Reverse

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Train Length: The TCS stimulators multi-pulse train stimulus and single pulse stimulus. The train length setting specifies the number of stimulus pulses delivered in each train. The range is 1 to 9.

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Inter Stimulus Interval (ISI): The ISI is the length of time from the start of one stimulus pulse to the start of the next stimulus pulse within a train. The range is variable from 1.0 to 9.9 milliseconds (ms).

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Maximum Intensity: The maximum intensity for the TCS-1 is 800 volts, while the maximum intensity for the TCS-1000 and TCS-4 is 1000 volts. The intensity for each device is variable in 2-volt increments. The maximum intensity may be set independently for each mode in the procedure setup file that uses the TCS1/TCS-1000/TCS-4.

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Repetition Rate: No repetition rate is needed or available for MEP mode types. The repetition rate may be set from 0.5 Hz to 1.0 Hz when using a TCS with EP and EMG mode types.

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Double-Train Stimulation: Delivers two trains of stimulation with a selected inter-train interval.

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Stimulus Pulse Width: 50µs (0.05 ms) fixed on the TCS-1. The stimulus Pulse Width is adjustable to 50µs or 75µs on the TCS-1000/TCS-4.

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Channel Selection: the TCS-4 also presents the option to select one of the four output channels as the active output.

NerveGuard NerveGuard is an extension of the Cascade’s triggered EMG modality and provides a convenient and easy-to-use interface for automatic pedicle screw stimulation, threshold determination, and documentation. You can perform a complete pedicle screw testing protocol in NerveGuard. For example, you can use the Continuous Mode during pedicle probing and taping as an early warning of a low threshold; use the Fixed Mode to stimulate the pedicle feeler as the surgeon feels the inside of the pedicle; use the Continuous Mode again as the surgeon drives the screw with the screw driver; or use the Screw Threshold mode to determine the threshold of the screw when in place. NerveGuard displays triggered EMG activity during screw stimulation and automatically switches to free-running EMG during periods of no stimulus delivery. 7

Elite Operators Manual

Cascade Elite Intended Use Cascade Elite The Cascade Elite is an electroneurodiagnostic device designed to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. It will acquire the data necessary to perform electroencephalography (EEG), transcranial electrical motor evoked potential (TceMEP), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potential (EP, brainstem auditory, visual, somatosensory), and Train of Four (TOF) analysis. The Cascade Elite is designed for use during the duration of the procedure only. Use of the Cascade Elite is to be istered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in an operating room or clinic. The Cascade Elite is intended for use during electroencephalography (EEG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (EP, brainstem auditory, visual, somatosensory), and Train of Four (TOF) procedures.

TCS Stimulators TCS-1/TCS-1000/TCS-4 constant voltage electrical stimulators are intended for transcranial cortical stimulation. The TCS-1/TCS-1000/TCS-4 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TCS-1/TCS-1000/TCS-4 Constant Voltage Stimulators are accessories to the Cadwell Cascade Intra-operative monitoirng system only. They are not stand-alone devices nor are they compatible with other systems. The TCS-1/TCS-1000/TCS-4 system is intended for use by a physician or trained technician under the supervision of a physician for the generation of Transcranial Electric Motor Evoked Potentials (TCeMEPs). The intended use environment for the TCS-1/TCS-1000/TCS-4 is the surgery suite in the hospital or other healthcare facility. The TCS-1/TCS-1000/TCS-4 is intended for use with electrodes approved by the FDA for human use.

Electrical Stimulator Guide For the Cascade Elite, Cadwell offers two generations of electrical stimulators: our latest ES-IX stimulator, and our legacy generation of electrical stimulator splitters (stim splitters). The tables below summarize the features of the stimulator options for each generation of stimulators.

ES-IX Stimulator The ES-IX stimulator represents a dramatic shift in Cadwell's line of electrical stimulators. It meets the IP64 standard for drip-proof equipment, and connects to the

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Introduction Elite and PRO base units through the Cadwell Peripheral Network (N) port. The ESIX does not interface with the original 16-channel Cascade. Stim Model (part number)

ES-IX Standard (190262-200)

Number of High Current Outputs

Low Current Maximum Output (Single Output)

Current

May be used in a Daisy Chain Application

Biphasic stimulation pulses option?

8

5 mA, 20 mA, 5 V, 20 V

Yes

Yes

Yes

High Current Outputs – Each high current output can output from 0 to 100 mA, 400 V maximum, with 0.5 mA resolution below 20 mA and 1 mA resolution above 20 mA. Low Current Maximum Output – The low current output is used to provide more precise adjustment of low level output currents than offered by the high current outputs. The low output of the ES-IX can be configured to four modes of operation. The amplitude resolution for each of the four modes is as follows: - 5 mA constant current (0.01 mA resolution) - 20 mA constant current (0.1 mA resolution) - 5 V constant voltage (0.01 V resolution) - 20 V constant voltage (0.1 V resolution) Current and Voltage – The Cascade will display current delivered to the patient when using the ES-IX in any constant-current mode. The voltage delivered is displayed for the low output in constant-voltage mode. This assists the practitioner in assessing the quality of the stimulator to patient connections. Daisy Chain – Two ES-IX stimulators may be attached together to provide a total of 16 high current and 2 low current/voltage outputs. This both provides additional outputs and allows the placement of an ES-IX near the head and another near the feet of the patient.

Electrical Stim Splitters Cadwell's original generation Cascade stim splitters allow a single constant-current electrical stimulator output from the Cadwell Cascade IOM to be multiplexed between multiple stimulation sites. There are currently seven different stim splitters being manufactured by Cadwell for use with the Cascade IOM. Each model features a unique combination of outputs and features. The following comparison chart presents features of each stim splitter model.

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Elite Operators Manual

Stim Splitter Model (part number)

Number of High Current Outputs

Low Current Maximum Output (Single Output)

Current

May be used in a Daisy Chain Application

Es5-5 CS 200)

(190203-

4

5 mA

Yes

No

Es5-20 CS 200)

(190204-

4

20 mA

Yes

No

ES5-100 CS (190221200)

5

None

Yes

No

ES16 CS 200)

15

20 mA

Yes

No

(190201-

High Current Outputs – Each high current output can output from 0 to 100mA, 370 VDC maximum, with a current resolution of 0.5 mA. (200 steps) Low Current Maximum Output – The low current output is used to provide more precise adjustment of low level output currents than offered by the high current outputs. The output resolution is 0.1 mA or less for the low current output. Current – The Cascade can display current delivered to the patient when using a splitter with current . This assists the practitioner in assessing the quality of the stimulator to patient connections.

10

Setup Instructions Hardware Setup Unpacking the System Congratulations on selecting the Cadwell Cascade Elite™ Intraoperative Monitoring system! It’s time to unpack the contents of your system. As you unpack, please carefully check to make sure the contents of the shipping box match the packing slip. NOTE: DO NOT discard any boxes or packing material until all items on the packing list are ed for.

You should receive the following as standard items: •

Cascade Elite base unitwith detachable power cord

•

Power/communications module, removable power cord, and power/com cable

•

Backup Cascade installation software CD

•

Two (2) or Four (4), 16-input amplifier extender cables

•

If ordered, Laptop or Desktop computer (with built-in Ethernet connection) with AC adapter and/or AC Power Cord

If you purchased your computer from Cadwell, all necessary Windows® and Cascade® software is already installed on your computer from the Cadwell factory and the network card is configured for use. There is no need for you to install any software. Please put the CDs that came with your system in a safe place. They are included as a backup copy only. Laptop computers may require you to make your own backup CDs for the computer. NOTE: If you purchased your computer form a source other than Cadwell, you must install software, activate the software licenses, and configure the network card. Please refer to the Software Setup section of the help file or Operator's Manual.

Please check for any optional items you may have ordered. These may include but are not limited to the following: •

Electrical Stimulator Module(s). (ES5-100, ES5-5, ES5-20, ES-16, ES5-5V, and ES510 STD and OPT)

•

ES-IX electrical stimulator

•

TCS-1/TCS-1000 Single Output Constant Voltage Transcranial Stimulator

•

TCS-4 Multiple Output Constant Voltage Transcranial Stimulator

•

Other EP stimulation devices such as insert earphones and goggles

•

ES Detector Module with ES Detector clip(s)

•

2nd Ethernet card (Desktop) or PCMCIA Ethernet card (Laptop) with Network cable

•

Instrument cart with instructions, grounding cable and screw, and any accessories such as a retractable arm or printer tray

•

Printer with cables and instructions 11

Elite Operators Manual •

External keyboard

•

External mouse

Position Elite Base Unit The Cascade Elite comes with mounting and cable guide accessories. See Operator’s Manual or Help Files for more information. The Cascade Elite base unit can be placed right next to the patient’s bed, reducing cable lengths, improving signal quality and reducing noise. The Elite may be secured under a Jackson table, clamped on an IV Pole, placed on the floor, hung on the bedrail, or mounted to the equipment rack. The Cascade Elite is water and dust resistant. The Quick Connectors are water resistant, although the Cascade Elite is not designed to be submerged.

Elite Base Unit Connections The following connections correlate with the peripheral device connection indicated in the image of the Cascade Elite base below. 1. Amplifier Input Extender Cable Jacks (Amps A, B, C and D) 2. Future Functionality 3. Electrical Stimulator/Stim Splitter Module (ESTIM) 4. Evoked Potential Stimulators (EP) 5. Future Functionality 6. Power/Com Module (Connection to PC) 7. High Voltage Stimulators (TCS), ESD Detector or LED Goggles/Pad (AUX 1 and 2) 8. Indicator Lights

12

Setup Instructions

When powered on, LED lights on the connector will indicate system status: D - Data: Flashes when there is communication between the main unit and the computer. L - Link: Lights when there is a connection established between the main unit and the computer. S - Status: Flashes in various patterns to indicate operation and status information. P - Power: Lights when power is provided to the main unit. The Cascade Elite meets IP 66 standards for water and dust resistance. The Quick Connectors are water resistant, although the Cascade Elite is not designed to be submerged. The connectors on the Cascade Elite come standard with Quick Connect fasteners. Connectors are labeled using text and graphics to indicate the peripheral devices that connect to each port. Please refer to the Peripheral Device Connection section for instructions about where each peripheral device connects.

Power/Com Module Connections 1. Power cord (to isolation transformer). 2. Laptop power cord connection 3. Power/Com cable (to Cascade Elite base unit). 13

Elite Operators Manual 4. Ethernet cable (to PC). 5. Grounding post (to PC and trolley cart).

Elite Cabling Setup Instructions To set up cables between the Cascade Elite, computer, power supplies and accessories: 1. Connect the Cascade Elite base unit to the power/com module: Connect the female end of the power/com cable to the power/com connector on the Cascade Elite base unit. Connect the male end of the power/com cable to the amplifier connection on the power/com unit. 2. Plug all amplifier input extender cables and accessory items (Electrical Stimulator Splitter, TCS, ES Detector Module, Insert Earphones, Goggles) into their respective inputs on the connector of the Cascade Elite base unit. 3. Connect the power/com module to the computer: •

Laptop: Plug one end of the network cable into the Ethernet connector on the laptop (usually in the back) and the other end into the connector labeled Ethernet on the power/com rear .

•

Desktop: Plug one end of the network cable into the Ethernet connector on the PC (usually labeled Amp) and plug the other end into the connector labeled Ethernet on the power/com rear .

4. Attach the main power cord to the AC power input on the power/com unit. 14

Setup Instructions 5. Attach the computer's power cord: •

Laptop: Locate the two-pronged laptop power cord coming from the power/com unit and plug it into the AC adaptor for the laptop. Plug the AC adapter cable into the power connector on the rear of the laptop labeled DC IN. Set aside the power cable that came with the AC adapter that normally plugs into the wall.

•

Desktop: Locate the desktop PC's power cord and connect the appropriate end to the back of the PC. Connect the other end to the isolation transformer or wall outlet.

6. Connect the printer (if supplied) to the laptop or desktop computer's LPT or USB port. Attach the printer power cord to the power receptacle on the printer. 7. Ground the computer: If necessary, attach the grounding wire screw to the laptop's external video connector or to a main chassis screw on the desktop PC. If you are using a cart, follow the instructions included with the cart to ground the cart to the instrument. 8. Plug all power cords into hospital grade wall outlets or isolation transformers. Do not plug power cords into common household power strips. If you would like to power multiple components of your Cascade system from a single power source, use the Isolation Transformer available from Cadwell. Please see Electrical Safety Requirements and Allowable Configurations for more information. 9. Turn the power/com module power on using the power switch on the front of the module. When the power/com unit is on, the LED on the front of the power/com unit will light. The Cascade Elite base unit receives power from the power/com module via the power/com cable. When the base unit is powered on, an LED next to the letter P on the connector will light. Additional Setup Requirements

! Configure the Network Card: The Cascade communicates with the PC over an Ethernet link. A dedicated Ethernet network card must be installed in the PC, and the card must be configured to a specific IP address. See Configuring the Network Card (Windows XP) for instructions. ! Update the Registry: After installing and configuring the network card, and installing the Cascade software, you need to update the Windows registry with the correct IP address for the base unit. From the Windows desktop, click Start, select Run, then type C:/Cadwell/Cascade/CascadeIP.exe and click OK. ! Set Up the Printer: Depending on the printer, you may be prompted to install printer software that came with the printer. See the instruction manual that came with the printer for specific instructions. Set the printer at a 300 or 600 DPI setting for the best results. ! Install the Cascade Software: For computers not purchased through Cadwell, you will need to install the Cascade software. 15

Elite Operators Manual 1. Insert the Cascade program DVD into the DVD drive of your computer. If autorun is enabled, the installation file will automatically unzip and Cascade Setup will begin. Otherwise, within Windows explorer, double-click on the drive you put the DVD into to begin the process. 2. Follow the on-screen instructions. Before you can run the program, see the instructions for Activating Software Licenses about entering a system key. ! Isolation Transformer: Depending on equipment installation, an isolation transformer may be required to limit unintentional leakage current. System installation must comply with the requirements of IEC 601-1-1 safety requirements for medical electrical systems. Refer to the Isolation Transformer Guidelines document 309002-000 if you are unsure about this requirement. See also:

Elite Base Unit Connections Peripheral Devices and Connections

Configuring the ES-IX Automatically Configure Your Current Setup Files to Work with ES-IX Included in Cascade 2.6 SP1 is a tool that will convert your standard electrical stimulator protocols to setup files that utilize the ES-IX. The tool is called the EsixStimConverter.exe, and is located in C:\Cadwell\Cascade\. Double left-click on EsixStimConverter.exe to start the tool.

The tool main menu comes up.

16

Setup Instructions

You can select and convert a single file, or select and convert an entire directory of procedure setup files. If your folder of setup files includes sub-folders (sub-directories), you will need to convert each directory separately. When the Stim Converter is finished processing your files, it will create copies of the setup files in the directory with the prefix "ES-IX". The files with this prefix are the converted setup files. The original files remain unchanged in the directory. Close the tool after you are finished converting your files.

ES-IX Configuration Options

The ES-IX stimulator has its own Stim Type in the Mode setup window. The ES-IX has the same capabilities as previous electrical stim splitters (ES 5-100, ES-16, etc.), and the options are accessed through the Setup Stimulator button in the Mode Controls, the same as for the electrical stim splitters. However, the ES-IX includes several new capabilities that were not available with the stim splitters.

17

Elite Operators Manual

Stimulation Outputs Available

The ES-IX has eight 100 mA constant-current output pairs and a single low output that can be configured to 5 mA, 20 mA, 5 V, and 20 V modes. Two ES-IXs can be daisychained, doubling the number of channels available.

18

Setup Instructions

Daisy-chaining ES-IXs

19

Elite Operators Manual

When ES-IXs are daisy-chained, one stimulator becomes outputs High 1-8 and Low 1, while the other becomes High 9-16 and Low 2. When you start a procedure with two ESIXs connected, you will be presented with the following popup. This message will also appear when you disconnect and reconnect the ES-IXs.

20

Setup Instructions

Choose OK to accept the ES-IX stim output assignments or Switch to swap which ES-IX is assigned channels 1-8 and which is assigned channels 9-16. Biphasic Stimulation

The ES-IX can produce biphasic stimulation pulses.

21

Elite Operators Manual

In Cascade 2.7, selecting biphasic stimulation causes the stimulating waveform to change such that the waveform looks like the one below. Both phases of the stimulus pulse have the same amplitude and pulse width. The pulse width specified in the stimulator setup is the pulse width for each phase, not the summed pulse width of both phases.

Multipulse Stimulation

In addition to standard single-pulse reprate stimulation and EMG train stimulation, the ES-IX can perform repetitive multipulse stimulation.

When the Multipulse Stim box is checked, the multipulse options become available. You can create multipulse trains up to 10 pulses with interpulse intervals from 0.5 to 10 ms.

22

Setup Instructions These short trains will be repeated at the Rep Rate specified in the Rep Rate box on the left side of the ES-IX Stimulator Setup dialogue.

Peripheral Devices and Connections It is important to attach stimulators and other peripheral devices to the correct connector on the Cascade Elite.

Peripheral Device

Connector

Amplifier Input Extender Cable

Amp A-D

Symbol

Records amplifier input.

ES-IX Stimulator

N

Stimulus Splitters

ESTIM

"N"

ES5-100, ES5-5, ES5-20, ES-16, ES5-5V, and ES5-10 STD and OPT

TCS-1/TCS-1000/TCS-4

Aux 1 or 2

"AUX 1", "AUX 2"

Transcranial-electrical motor cortex stimulator is an FDA-approved high-voltage electrical stimulator. Audio and Visual Peripherals

EP

Headphones, inserts and the pattern reversal monitor are audio and visual stimulators that must be connected to the EP cable port. ES Detector Module

Aux 1 or 2

"AUX 1", "AUX 2"

Aux 1 or 2

"AUX 1", "AUX 2"

Aux 1 or 2

"AUX 1", "AUX 2"

The electro-surgery (ES) detector mutes EMG audio and pauses EP modes when electro-surgical devices are being used. VEP Goggles/LED Pad The Visual Evoke Potential (VEP) goggles are visual stimulators used during surgery. CV-2

23

Elite Operators Manual This electrical cortical stimulator can be set to output two (2) 400-volt stimulations.

Cabling Diagram - Elite to Desktop PC The following connections correlate with the peripheral device connections for use with a desktop PC, as shown below. Note: Your desktop PC may have a different connection than shown in this example. Do not use extension cords or power strips.

Cabling Diagram - Elite to Laptop PC The following connections correlate with the peripheral device connections for use with a laptop PC, as shown below. 24

Setup Instructions Note: Your laptop may have a different connection than shown in this example. Do not use extension cords or power strips.

Cascade Elite Features & Accessories The Cascade Elite was designed to be practical and convenient. Its features and accessories complement its simplicity, versatility and innovation. V-Blocks The Cascade Elite is practical.

25

Elite Operators Manual

Four directional V-Blocks on the bottom of the Cadwell Cascade Elite provide connections for Cascade Elite accessories, including the V-Block Clamp, the Cable Guide and the Surgical Table Rail Handle. The accessories each have a corresponding V-Block mount which slides and automatically locks onto the V-Block for a secure fit. To release the lock, pull the black pin up and slide the mount off the block. V-Block Clamp The Cascade Elite is versatile.

The V-Block Clamp allows the Cascade Elite to suspend from a vertical IV pole or a thick square or round horizontal bar. Realigning the screw socket holes on the V-Block Clamp allows for 90°, 180° and 270° unit rotations on either a vertical or a horizontal post. Turning the knob opens or closes the clamp, allowing for placement, removal and adjustment of the Cascade Elite across a rail or up or down an IV pole. Quick Connect The Cascade Elite is innovative.

26

Setup Instructions

Cadwell has eliminated the hassle of hooking up thumb-screw cables. The Cadwell Quick Connect (patent pending) stud and socket set provides secure connections between cables and the Cascade Elite. While it is possible to attach the Quick Connect stud and socket with an aligned push, it is easier to align the male end of the cable with the female end on the Cascade, but apply more force on one stud and socket end, and then the other. The cable is connected when both Quick Connect stud pairs audibly click together. The Quick Connect has a solid linear connection. Try pulling the cable straight out. Now remove the cable like you installed it: apply torque on one Quick Connect socket end, and then the other. The Quick Connect comes off in a snap! While the Quick Connect allows easy detachment, is also important to keep your cables connected while the Cascade Elite is in use. Cable Guide The Cascade Elite is simple.

27

Elite Operators Manual

Design specifically for the Cascade Elite in conjunction with Quick Connect, the Cadwell Cable Guide helps assure cables are not inadvertently disconnected. The Cable Guide's cable holes align with the rows of cables connected to the Cascade Elite. The Cable Guide pulls the cables at an angle, helps organize cables, and provides a lifted suspension when the Elite is sitting horizontally on a counter or floor, allowing cables to fit underneath the unit and out of the way. Surgical Table Rail Handle The Cascade Elite is convenient.

28

Setup Instructions

A foam-padded hand grip allows for comfortable and easy transportation of the Cascade Elite. The handle’s square-edged groove is also a perfect fit for a surgical table rail. The handle, like all of these accessories, can be mounted on any of the four VBlocks, so you have control over the directional placement of the Cascade Elite and its cables.

Mounting V-Blocks on IV Pole The V-Block accessories may be configured in a variety of ways to best suit your preferences. Position the Cascade horizontally on an IV Pole

The standard configuration of the V-Block Clamp allows the Cascade Elite unit to be mounted horizontally on an IV Pole.

29

Elite Operators Manual

To configure the Cascade Elite horizontally: 1. Place the Cascade Elite bottom up on a flat surface. 2. Attach the Cable Guide on the end V-Block mount closest to the connections. 3. Attach the Surgical Table Rail Handle to the end V-Block mount closest to the Cadwell logo. 4. Attach the V-Block Clamp to either side V-Block mount, and open the clamp fully using the hand knob. 5. Lift the Cascade Elite into place on the IV Pole, and tighten the hand knob until secure. Position the Cascade vertically on an IV Pole

For some surgical technicians, it may be easier to move the unit to and from the IV Pole by placing the unit in a vertical position. This allows an easier grip on the Surgical Table Rail Handle.

30

Setup Instructions

To configure V-Block accessories for a vertically-positioned Cascade Elite: 1. Place the Cascade Elite unit bottom-up on a flat surface. 2. Remove the V-Block Clamp from the Cascade Elite. 3. Using a Phillips screwdriver, unscrew the Clamp from the sheet metal V-bracket 4. Turn the Clamp sideways so the Clamp hand knob faces away from the Vbracket (see image above). 5. Using your screwdriver, secure the Clamp to the V-bracket. 6. Attach the V-bracket to one of the side mounts on the Cascade Elite unit. 7. Attach the Surgical Table Rail Handle to the end V-block mount closest to the Cadwell logo. 8. Attach the Cable Guide to the end V-block mount closest to the connections. 9. Lift the unit by the Surgical Table Rail Handle with one hand, position the VBlock Clamp on the IV Pole and tighten with the other hand.

Attach Cascade to a Jackson Table Orient the clamp on the V-block as you did by placing the base vertically on the IV pole. Attach the V-block on an end of the base, and clap to the end of the table.

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Elite Operators Manual

Printer Setup All necessary printer drivers and software is already installed on your computer from the Cadwell factory. There is no need for you to install any additional drivers or software. Please put the CDs and documentation that came with your printer in a safe place for future reference. NOTE: If you purchased your printer from a source other than Cadwell, you must install printer driver on the PC. Please refer to the instruction manual that came with your printer for instructions on setting up your printer.

Using the Hardware Simulator If you don’t have any Cascade hardware (i.e., Cascade base unit, Amplifier, and ES Stimulator box) hooked up to your computer, you can instruct the software to use a Hardware Simulator to supply synthesized traces/waveforms, allowing you to run the program for training and learning purposes. To turn ON the Hardware Simulator:

1. Open My Computer on the Windows desktop. 2. Open Local Disk (C:). 3. Open the Cadwell folder. 4. Open the Cascade folder. 5. Open the file UseHardwareSimulator.reg. a. Click Yes in the Registry Editor.

32

Setup Instructions b. Click OK in the Registry Editor. 6. Close the C:\CADWELL\Cascade folder. To turn OFF the Hardware Simulator:

1. Open My Computer on the Windows desktop. 2. Open Local Disk (C:). 3. Open the Cadwell folder. 4. Open the Cascade folder. 5. Open the file UseHardware.reg. a. Click Yes in the Registry Editor. b. Click OK in the Registry Editor. 6. Open the file Cascade.bat. a. Allow the data to compile. 7. Close the C:\CADWELL\Cascade folder.

TCS Setup Unpacking and Setting up TCS System Unpacking and Equipment Setup

Remove the TCS from the packing material and that all components are present and not visibly damaged. Read all instructions carefully before use. Cadwell recommends pre-assembly and testing of the system. proper understanding of the system prior to use. Setting up the TCS Stimulators

Connect the 14-pin auxiliary cable (supplied) from the Aux 1, 2 or 3 port on the back of the Cascade to the Auxiliary Connection on the TCS. Screw tight the connector screws that hold the cable to the port. TCS Software

The software used to control the TCS is preinstalled on Cascade systems.

Preparing Patient & Equipment for Data Collection This topic will provide an overview of the steps required to prepare the patient and equipment for data collection. NOTE: This topic is intended as a guide to setting up for motor evoked potential monitoring. This topic is not a substitute for proper training. The Cadwell TCS stimulators should be used only by qualified medical professionals who have been thoroughly trained and are experienced in its use.

The following equipment is required to prepare for data collection: •

TCS Stimulating Unit (TCS-1, TCS-1000, or TCS-4)

•

Auxiliary Cable

33

Elite Operators Manual •

Cascade Surgical Monitoring System

•

Stimulating Electrodes

Preparing the Patient

Do not connect TCS output leads to anywhere other than the head. This eliminates the potential for transthoracic currents in any failure mode. Prior to testing, place stimulating electrodes on the patient’s scalp according to your laboratory protocol. Several different configurations of stimulating electrodes have been reported including stimulation between C1 and C2 using the International 10-20 standards for EEG electrode placement.1 Next, place recording electrodes according to the location(s) you wish to record from. Common recording locations include the muscles of Abductor Pollicis Brevis, Tibialis Anterior, Gastrocnemius, and Abductor Hallucis. Connecting the Patient to the TCS-1/TCS-1000 unit

In “normal” stimulating mode the red jack is the anode (+) and the black jack is cathode (-). In “reverse” stimulating mode the red jack is the cathode (-) and the black jack is the anode (+). For transcranial motor stimulation, the anode electrode is more effective than the cathode1. Plug the stimulating electrode from the left side of the patient’s scalp (C1) into the red output jack on the TCS-1/TCS-1000. Plug the stimulating electrode from the right side of the scalp (C2) into the black output jack on the TCS-1 /TCS-1000.. Electrode extension cables may be used between the stimulator outputs and the stimulating electrodes if additional length is needed.

34

Setup Instructions Confirm the polarity settings of the MEP modes in the procedure setup file. Confirm that the Left MEP mode is set to Reverse stimulation and that the Right MEP mode is set to Normal stimulation. Connecting the Patient to the TCS-4 unit

In “normal” stimulating mode the red jack is the anode (+) and the black jack is cathode (-). In “reverse” stimulating mode the red jack is the cathode (-) and the black jack is the anode (+). For transcranial motor stimulation, the anode electrode is more effective than the cathode. For each output you would like to connect to the patient, plug the stimulating electrode from the left side of the patient’s scalp (C1) into the red output jack on the TCS-4. Plug the stimulating electrode from the right side of the scalp (C2) into the black output jack on the TCS-4. Electrode extension cables may be used between the stimulator outputs and the stimulating electrodes if additional length is needed. Confirm the polarity settings of the MEP modes in the procedure setup file. Confirm that the Left MEP mode is set to Reverse stimulation and that the Right MEP mode is set to Normal stimulation. Connecting the TCS to the Cascade

Connect an auxiliary cable (supplied) from any one of the 3 Aux ports on the back of the Cascade to the 14-pin Auxiliary connection on the TCS(located on the back of the TCS unit). When the TCS is properly connected to the Cascade and the Cascade is powered on, the Power On LED located on the top of the TCS unit to the left of the Cadwell Cascade logo will light. This LED indicates that the TCS unit is powered on, connected to the Cascade and ready for use. Connecting the Patient to the Cascade

Plug the recording electrodes from the patient into the preamplifier of the Cascade Surgical Monitoring System according to the procedure setup file being used. Please refer to the Cascade Operator's Manual for detailed instructions on using the Cascade Surgical Monitoring System.

Software Setup Software Setup Overview If you purchased your computer from Cadwell, all necessary Windows ® and Cascade® software is already installed and the network card is configured for use. You need not install any Cascade software. Please put the DVDs that came with your system in a safe place. They are included as a back-up copy only. NOTE: If you purchased your computer from a source other than Cadwell, you must install software, activate the software licenses, and configure the network card. Please refer to Software Installation Instructions and Configuring the Network Card.

Software Installation Instructions 35

Elite Operators Manual Please read all instructions prior to performing the upgrade.

1. Version 2.7 was designed and tested to run on Windows 7. 2. You should be logged in as an on your computer when you perform the installation. 3. The current version of Cascade should be completely removed before starting the version 2.7 installation process. Instructions for removing the current version of Cascade are included in this document. 4. Internet access is recommended during installation. 5. Version 2.7 verifies and/or installs the following applications before installation: •

Microsoft .NET Framework 4 Client Profile

•

2005, 2008 and 2010 Microsoft C++ redistributable

•

Microsoft Windows Media Player 11

•

Windows Installer 3.1 or higher

•

Cascade DMLocalServer64

New PC Installation Notes:

If you purchased your new PC from Cadwell, the Cascade software is already set up. If your computer was purchased from a source other than Cadwell, you will need to follow these instructions to install your Cascade software and then you will need to configure the network card. Installation Instructions

First, uninstall the current version of Cascade. This will not remove your unique procedure setup files, report templates, or patient data files. 1. Click on the Start button (or Start Orb) and select Control . 2. Open Programs and Features. 3. Double click on Cascade and then select Yes when prompted to uninstall Cascade.

4. Follow the instructions on the screen to remove the Cascade application. 5. Close Add and Remove Programs and the Control windows. Next, remove any leftover application files from the Cascade directory. 7. Click the Start Orb, then place your cursor in the “Search programs and files” text field. 8. Type in C:\Cadwell\Cascade, Click OK. 9. Leave any folders in this directory such as Patient Data, Setup files, Data, Report Templates and any other directories (i.e., Folders). Do not remove files from within these folders. Excluding the folders, highlight any files in this directory and delete them. 36

Setup Instructions Keep ALL Folders

10.

Delete Files NOT in a Folder, e.g.

Close the Cascade folder window.

Now install the applications for Cascade version 2.7. Begin by opening the installation program on the DVD. 11. If the DVD does not autorun, double click My Computer, Open the Optical Drive, then double left click on the Install.exe file. Wait for 3-5 minutes while the installer extracts all of the installation files to: C:\Cadwell\Cascade_2.7_Files. This will ensure that all of the installation files, third party software, and drivers are accessible for future access on your PC. Once the automatic extract is completed, the Cascade Setup will begin automatically. 12. If .Net 4.0 Client Profile is not already installed on your computer, you will first need to agree to their end license agreement. Click Install when you receive the following prompt regarding installation of the prerequisite applications and software updates. 13. Microsoft’s .NET installer will install the necessary prerequisite applications and software updates. This may take several minutes, depending on the number of updates needed and the speed of your computer. 14. Installing .NET will prompt for a reboot. If prompted to restart your PC, restart, then open the Cascade version 2.7 installation at: C:\Cadwell\Cascade_27_Files Double left click on the setup.exe file. The setup file will begin installing again, but will skip the .NET 4.0 Client Profile install. After the prerequisite applications and software updates are installed, the Cascade Setup Wizard will begin automatically. Click Next. 15. Read the Release Notes. Then click the Next button again. Note: Cascade automatically copies a documents folder to the C:\Cadwell\Cascade directory. This folder will contain a copy of the release notes along with other ing documentation.

16. Confirm or change the destination folders and click the Next button.

37

Elite Operators Manual Note: If

you change the directory to which you install Cascade, you will need to configure the Cascade registration configure file and re- the files after completing the install. Instructions for this process begin at step 21. 17. Confirm that you wish to install Cascade version 2.7 by clicking the Next button. 18. The Cascade application will take several minutes to install. When the installation is complete, click the Close button to exit the installation process. 19. Start the Cascade program by double clicking the Cascade icon on the Windows Desktop. 20. Select Start New Procedure. The Device Flash Utility may begin an automatic update of your base unit firmware version if it is not the latest. When the Firmware update is complete, power OFF the base unit, wait for 10 seconds, then power ON the base unit. 21. hardware version numbers by selecting About Cascade… from the Help menu. Hardware Type

Cascade Version

Base Version

Junction Board SW

ESIX SW Version

Estim Board SW

16Channel Cascade

2.7

3.27

2.2

N/A

5.8 or 5.9

32Channel Cascade Elite

2.7

3.86

2.2**

V 0.11

5.9*

Cascade PRO (16 or 32)

2.7

1.09

2.2**

V 0.11

N/A

1.

22. Open Cascade.exe.config from your chosen Cascade installation directory in a plain text editor.

2.

23. Once the text file is open, perform a Find and Replace. You will search for C:\Cadwell and replace that text with your selected installation directory. The directory setting should be replaced in 5 locations.

3.

24. As an example, if I changed the installation directory to P:\Cadwell\, I would open Cascade.exe.config from P:\Cadwell\Cascade. Within the text file, I would search for C:\Cadwell and replace it with P:\Cadwell.

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Setup Instructions 4.

25. Open the Cascade tool by double-left clicking on Cascade.exe.

5.

26. Select All.

6.

27. After the registration process completes, close the Cadwell tool.

Configuring Cascade in Windows 7 This document will describe how to configure Windows 7 for optimal performance of the Cascade program. Perform the following steps:

1. Elevate Cascade to “Run as ” when entering the system key for the Cascade license: After installing Cascade on Windows 7, right click on the Cascade icon on the Desktop. Select Run as . Enter the system key as given to you by Cadwell staff.

2.

Configure the Network Card:

Click on the Start Orb then the Control . Change back to View by Category. Click on “View network status and tasks” under the “Network and Internet” heading.

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Then click on “Change Adapter Settings” on the left hand task pane. This will show all the network connections available on the computer.

Right-click on the LAN or High-Speed Internet connection that will be used to communicate to the base unit and click on “Properties.”

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Setup Instructions

Uncheck all the protocols in the list except for the Internet Protocol Version 4(T/IPv4). Then double-click on that protocol and change the radial button from “Obtain an IP address automatically” to “Use the following IP address.”

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Input the default Cadwell® IP address used for all our machines. It is 192.168.113.66. The default Subnet Mask is 255.255.255.0. Once those addresses are added, click on the Advanced button in the bottom right-hand corner of the screen. Click on the WINS tab and uncheck the “Enable LMHOSTS lookup” check box and change the Net-Bios setting from Default to “Disable NetBios over T/IP”.

Click OK three times until it hour-glasses for a little bit and then you should see your local area connection indicate that it is connected.

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Setup Instructions

3.

Running CascadeIP.exe on Windows 7:

After installation of the Cascade software has been completed, you will need to run the C:\Cadwell\Cascade\CascadeIP.exe program. The first time you doubleleft click on CascadeIP.exe, you will get an error message: “The Cascade controller was not detected.” Immediately thereafter click OK, and then doubleleft click on CascadeIP.exe a second time and the registry will be updated correctly. This program updates the system registry with the IP address of the Cascade base unit. See the graphic below for the correct response of running CascadeIP.exe. Once this has been done, the network card setup will be complete.

4.

Add the Run Command and Printers to the start menu:

Right-click the Start Orb and click “Properties.” In the start menu tab click the “Customize” button.

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Check the “Run Command” and “Devices and Printers” boxes and click OK twice.

5. Fix the New Program Window so that the ReportGen program will automatically come to the front when launched. This is per the Microsoft Knowledge Base article #886217: To resolve this issue, modify the value of the ForegroundLockTimeout registry entry in Registry Editor. To do this, follow these steps:

1 Click the Start Orb, click Run, type regedit in the Open box, and then click OK. 2 In Registry Editor, locate and then click the following registry subkey: HKEY_CURRENT_\Control \Desktop 3 In the right pane, locate and then double-click ForegroundLockTimeout.

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Setup Instructions 4 Under Base, click Decimal, type 0 in the Value data box, and then click OK. Note The default decimal value for the ForegroundLockTimeout registry entry is set as 200000. 5 Quit Registry Editor. 6 Restart your computer.

*This must be done for each on the system.

6.

Add the “Computer” and “Network” icons to the desktop:

Right-click on the desktop and click Personalize. Click on “Change Desktop Icons” under Tasks.

Check all the boxes, for the available icons. (or at least check Computer and Network).

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7.

Disable protection on Screen Saver:

Right-Click anywhere on the desktop and click “Personalize.” Click on the Screen Saver link in the lower right corner.

Then uncheck the “On resume, display the screen” and click OK.

8. Configure the Power Settings for a Laptop or Desktop: Click on the Start Orb, then Control . Change the “View by” setting to Small Icons. In the control list click on “Power Options”. Select the High Performance option. If you don't see this option, click on Show additional plans.

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Setup Instructions

Click on the “Change Plan Settings” link under High Performance.

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Click the dropdown list for both “Turn off the Display” and “Put the Computer to Sleep” and set them to NEVER.

Next click the “Change Advanced Power Settings” link and set the “Link State Power Management” setting to OFF. That only needs to be done under the PCI Express setting. Then click OK out of everything to set all the power settings.

9. Change the default Windows Theme. This fixes the issue with the L and R side buttons in the mode setup window. Copy the Cascade.themepack from the installation CD under Extras\Cadwell\Wallpaper\ to your Desktop. Double-left click on the Cascade.themepack icon on your Desktop. This will apply the Cascade themepack and correct the fonts needed to access all of the Cascade menu options.

Activating Software Licenses 48

Setup Instructions The Cadwell Cascade Control is used to activate the Cascade software license using a System Key provided by Cadwell. To access the Cadwell Cascade Control : •

On the Cascade start page, select System Setup

•

Click the Edit Customer Options button on the General tab

The first time the software is installed, a unique "System ID" is generated automatically. The System ID number uniquely identifies a computer. To authorize operation of the Cascade software, the correct System Key must be entered. The System Key is specific to a particular computer and will only work on the system for which it was issued. When multiple computers are used at a site, a different System Key is required for each computer. This control also shows the software features enabled on your system in the Cascade Options area. If your system is not configured for a feature you would like enabled, please our customer department for software licensing options (800.245.3001).

Obtaining a System Key

49

Elite Operators Manual System Keys are issued by Cadwell. Instruments ship from the factory pre-configured with the System Key already entered. If you change the computer used with your base unit, Cadwell by telephone or fax to obtain a new license key. See Cascade Customer for information. When calling by telephone, be prepared to supply the instrument serial number or customer ID number and the "System ID" number displayed by the Cadwell Cascade Control . When using a fax, be sure this information is included. Take particular care to copy the System ID number correctly and clearly. If requesting keys for multiple computers, be prepared to supply the required information for each computer. Keys can be typed in by clicking the Change System Key button. A dialog displays which allows entry of the System Key number. Dialog Controls

System ID (Read Only) - The System ID number is generated automatically when the software is initially installed. The number uniquely identifies the computer on which the software is installed. When requesting a System Key from Cadwell, the System ID number must be supplied. System Key (Read Only) - The current System Key number. The key enables operation of the Cascade software and controls which optional features are available. The System Key will only work in combination with its corresponding System ID. Attempting to re-use the System Key on another computer will not work. Change System Key - Click the Change System Key button to display the Change System Key dialog. The dialog allows the entry of a new system key. If an invalid key is entered, a message displays to indicate that the key is invalid. The key must either be corrected or the Cancel button can be clicked to exit the dialog without changing the system key. Cascade Options - The Cascade options list box displays the status of optional software features. If the check box is checked the feature is enabled. If a feature is unavailable, the option will be displayed in gray and it will not be possible to enable it. Unchecking a box will disable the associated feature. Enable Features EMG – Enables EMG data acquisition. EP – Enables EP data acquisition. EEG – Enables EEG data acquisition. Live Video – Enables display of live video from a digital camera. TOF – Enables Train of Four data acquisition. Remote Server – Enables a Cascade with data acquisition capability to act as a server for remote monitoring client computers. Network Base Control - Enables control of the Cascade Elite base over a LAN connection. 50

Setup Instructions Reader License – Enables review of patient data files and remote client capabilities. OK - Click the OK button to finalize any changes and exit the control application.

Creating a Shortcut to a Network Location To set up Cascade desktop shortcuts, and to move data files to a networked system, follow these directions. Note: The folders used in this example will be different from yours if the Cascade application is not loaded on the networked system to where the files on the remote reader system are to be moved.

1. From the Windows desktop, right-click on the Start menu. 2. Select Explore.

3. In the left window pane, single-click on the plus sign next to the Cadwell folder. NOTE: If the Cascade application is not yet loaded on this system, select the desired directory to which you wish the Cascade files are to be copied.

4. Single-click on the plus sign next to the Cascade folder. 5. Under the Cascade folder, under Checklists, right-click the data folder. 6. Select Sharing and Security.

7. Click on the Sharing tab. •

Select Share this folder.

•

Create a Share name and set security preferences.

•

Click Apply.

•

Click OK.

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8. Close Windows Explorer, but leave the computer turned on. Create the Cascade Shortcut

Turn the Cascade system on. Note: Both systems must be connected to the network and turned on.

1. From the desktop of the Cascade system, right-click the Start button. 2. Select Explore. 3. In the left window pane, single-click on the plus sign next to the Cadwell folder. 4. Single-click on the plus sign next to the Cascade folder. 5. Right click on the Patient Data folder below Cascade. 6. Select Send To > Desktop (create Shortcut).

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Setup Instructions

7. Still in the Windows Explorer, scroll down on the left and single-click on the plus sign next to My Network Places. 8. Single-click the plus sign next to Entire Network. 9. Single-click the plus sign next to Microsoft Windows Network. 10. Single-click the plus sign next to the workgroup or domain where the networked computer is located. (In this example the remote networked system is in the Cadwell workgroup).

12. Single-click the plus sign next to the remote system’s computer name. (In this example we shared the Cadwell folder on the remote system. The Cascade application will automatically look for data files in the data folder located under the Cascade folder, under the Cadwell folder). 13. Right click on the data folder (or desired folder) on the remote system and select Send To> Desktop (create Shortcut).

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14. Close Windows Explorer. Rename Files

1. On the computer’s desktop there are two new shortcuts to data. They need to be named appropriately to be able to differentiate which one is for the Cascade and which one is for the remote system. 2. Right click on the Shortcut to data folder icon and select Rename. 3. Rename the folder to Cascade Data Folder and press enter to keep the name.

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Setup Instructions

4. you have the folders named correctly by opening the Remote Data Folder. •

Look in the address line. Systems located elsewhere on the network will start out with two back slashes in the address line (\\). See example below.

Move Cascade files to Network

1. Open the Cascade Data Folder on the desktop. 2. Select the files you want to copy (If you wish to select more than one but not all of the files, hold down Ctrl on your keyboard and single-click each file. If you wish to select all of the files, single-click in the window and press Ctrl and the A key). 3. In the Edit pull down menu, select Copy. 4. Close or minimize the Cascade Data Folder. 5. Open the shortcut to the Remote Data folder. 6. In the Edit pull down menu, select Paste. Note: The remote system must be turned on and connected to the network to move files to it.

Minimum Computer Requirements

55

Elite Operators Manual The computer used to run the Cadwell Cascade, Elite, or PRO is an integral part of the neuromonitoring system. For optimum performance of the system use a computer that meets the following criteria.

Minimum Operating System

Processor

Hard Disk Drive

Memory (DRAM) Archive Device

Graphics

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Recommended

32-bit or 64-bit Windows 7 (Please see Configuring Cascade for Windows 7 for additional setup instructions, document 369028-626 on DVD) I7, 2.9 GHz Quad Core processor, Cascade 2.6 SP1 will run much slower on computers with singlecore processors. 80 Gigabytes Capacity, 5 GB free-space

40 GB free space

8 GB Any Windows ed device 1024 x 768 resolution; 16 MB, 32-bit color depth (ed, but not

1600 x 900; 64 MB (recommended) ATI Graphics

Setup Instructions recommended) Base Unit Communication

Network Connectivity

Regulatory Requirements

10 Base-T Ethernet connection Second Ethernet connection (e.g., Ethernet card) required for simultaneous connection to base unit and network U.S. and Canada: Equipment must meet UL1950 or IEC950 European Union: Equipment must meet EN60950

Editing System Setup System Setup - Overview System settings are settings that apply to the Cascade software at a system level and are the same regardless of the procedure setup file being run. System settings can be set differently for each name logged in to Windows. Five tabs comprise the system settings. Tab Name General tab

Remote tab

Description Allows you to set the Data and Setup files directory paths, select the frequency of the notch filter and turn on the Title Bar. It also provides buttons for setting up the Report Header and for changing Customer Options. Used to specify connection speed, and select how to handle view

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Elite Operators Manual changes on the remote reader. Chat tab

Event Filtering Tab Colors tab

Used to configure Chat Box options. The chat box is used to send text messages back and forth between the remote monitoring client and the acquisition (Server) Cascade. Used to select which event marks will be displayed along the time line of the procedure. Used to select the colors for the window background, traces, cursors, trace labels, etc.

To edit the system setup: From the Edit menu, select System Setup to display the System Setup window. Make any necessary changes to the selected tabs.

General Tab Select specifications in the General tab: Data Files - Enter the directory location for all data files (.smd). NOTE: Your computer must have access to the directory location indicated in the Data file Directory filed in order to start a procedure.

Setup Files - Enter the directory location for all setup files (.smp), and amplifier input files (.amp). Report Header - Edit the header template that is included at the top of all reports. Edit Customer Options - Display the Cadwell Cascade Control , from which you can enter the System Key for an instrument and control enabling of optional software components. A System Key is required to enable the Cascade software on a particular computer and to configure which optional features will be available. See Activating Software Licenses topic for more information. Show Title Bar - When this box is checked the Cascade application will respond to the Windows Tile feature. The Windows Tile feature allows you to have multiple sessions of Cascade running at right click on the Task Bar to select one of the two Tile Windows options. This will equally layout the open applications on the screen.

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Setup Instructions

Tiled Cascade sessions.

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Elite Operators Manual

Remote Tab Select specifications in the Remote tab: Remote Computers: Select remote servers. Add: Select a remote computer from the network and add it to the server field. One server can be viewed by three clients simultaneously. Delete: Remove a server from the list. Connection Speed: Select speed of network connection. When checked, "Maintain View Sync with Server" verifies reader system will always show the same view as the acquisition system. The reader may configure the content and layout of the views to be different than the acquisition system. There is no EMG when using a slow connection like modem to modem.

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Setup Instructions

Chat Tab Select specifications in the Chat tab: Auto Send Message on Enter Key - Pressing the Enter key after typing a chat message sends the message to the recipient. On Message Auto Popup and Beep - When a new message is received, the message can automatically display and/or your system can sound a beep. Save to Log - Records all chat messages to a text file. Using the Chat feature can be done without interrupting data acquisition. This option must be active at the beginning of a monitoring session to take effect.

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Event Filtering Tab Select specifications in the Event Filtering tab: Event Type - Select the type of events which will appear on the procedure timeline. Priority - Select the events which will appear on the procedure timeline by their priority. Event Type - When reviewing a procedure use this area to remove events from the timeline that are entered from comments.

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Setup Instructions

Colors Tab Select color specifications in the Colors tab: •

Click on the box corresponding to the item you want to change

•

Select a new color from the color palette

Colors can be changed before, during, or after a recording. You may use the folder icon to load a factory default color profile or to load a custom color profile. Use the diskette icon to save the current selections to either the Custom 1 or Custom 2 profile.

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Performance/Operational Recommendations To get the most out of your Cascade Elite , follow these recommendations: Impedance Measurement – in order to measure impedance there must be a valid active, reference, and ground electrode connected to the amplifier. Each amplifier requires one ground electrode to be placed on the patient. Pods A and B go to Amplifier 1. Pods C and D go to Amplifier 2. In order to measure the ground impedance correctly, the impedance of the active and reference electrodes must be between 0.2 ohms and 50.0 kOhms. Common Mode Rejection Ratio – if a defined amplifier channel is not being used in any acquisition mode, you should delete this channel from the test montage and channel settings for each mode the amplifier channel is used in, for the greatest CMRR and reduced noise. Low Current Electrical Stimulator (Low1 and Low2) – for maximum output, the impedance across the cathode (-) and anode (+) must be less than 8 kOhms.

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Setup Instructions Amplifier Input Extender Pods – for best performance, run both the active and reference inputs for a channel through the same extender pod. Also, use short electrode lead wires. Turn OFF Special Effects in Windows — 1. Right click on the Windows desktop and select Properties. 2. Select the Appearance Tab 3. Click on the Effects button 4. Un-check the box labeled "Use the following transition effect for menus and tooltips." 5. Un-check the box labeled "Show window contents while dragging." 6. Click OK in the Effects window. 7. Click OK in the Display Properties window. Set Windows Theme for Windows 7 To Cadwell 1. Click on the Start button. Type the following in the box above the start button, C:\Cadwell\Cascade\Cascade.themepack. 2. Click the X in the upper right hand corner to close the Personalize window. Securely ground the Laptop or Desktop PC – ground the laptop or desktop (via a grounding wire) to the back of the Cascade Elite Power/Com Module. If the Cascade Elite is sitting on a metal cart, ground the cart to the back of the Cascade Elite Power/Com Module as well.

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Getting Started - The Basics The Basics Working with Basic Windows® The Cascade Elite application works within the Microsoft® Windows 7 operating system environment. The Cascade Help file helps answer questions about how to use Cascade software. For information specifically ing Windows functions outside the Cascade software, refer tot he Microsoft Windows Help and Center. To open the online Help file for Windows

1. On the Windows taskbar, click Start. 2. Click Help & .

Turning Equipment On and Off Do not turn the instrument base on or off while a patient is connected. To turn the equipment on

1. Connect the power/com module, amplifier input extender cables, stimulators, and accessories (if not already connected). 2. Turn equipment on in the following order: o

Power/com module (also powers the Cascade Elite base unit)

o

Computer

o

Monitor (desktop units only)

o

Printer (if connected)

NOTE: If you are using the isolation transformer, you only need to turn on the isolation transformer power switch.

To turn the equipment off

1. Close all programs that are running on the computer. 2. On the Windows taskbar, click Start, Shut Down, select the Shut down option, and click OK. 3. Turn off equipment in the following order: o

Power/com module (also powers the base unit)

o

Computer

o

Monitor (desktop units only)

o

Printer

NOTE: If you are using the isolation transformer switches, turn off only the power switch. The monitor, printer, and power/com switches can remain on. The next time you start the system, turn on only the power switch. NOTE: You do not need to disconnect the power/com, amplifier input extender cables, stimulators, or accessories. You may leave them connected.

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Opening and Closing Cascade Software To open Cascade Elite

With the Cascade Elite equipment turned on, start the Cascade software from your computer by: o

o

Double-click the Cascade icon on the Windows desktop, or

From the Windows toolbar, click Start, All, Programs, Cadwell, and then Cascade.

To close Cascade Elite

When you close a patient file or exit from Cascade while in a patient file, all data is automatically saved to the patient's file. o o

To close a patient file without exiting from Cascade: From the File menu, click Close Procedure. To exit from Cascade: From the File menu, click Exit. You can also click the Red 'X' in the upper right corner. Click Yes to close the Cascade software.

Working with Cascade Software Cascade Elite Start Page Overview The start page is the first page displayed when you open the Cascade program. There are nine actions to choose from, or you may select the Help option to access the Cascade Elite Help files. Record Data

Start New Procedure allows you to access settings files in Cascade Elite testing. You may select a procedure setup file for the surgery, enter patient information and begin running modes and monitoring data.

Append To Procedure allows you to open patient data files that already exist in Cascade Elite testing and supplement them with additional data (traces). This feature is often used if a presurgery screening was completed before the patient entered the operating room.

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Getting Started - The Basics Read Data

Review Procedure allows you to access patient data files and analyze existing information from the Cascade Data File dialog box. The arrows on the time bar may be used to jump to events in the data file. Data is displayed for that time during the surgery; you may move around in the file and review the trends, video and trace data at any time during recorded surgery. Remote Monitor allows you to connect a remote unit to the Cascade server. You may choose from the options available or browse the network to find your connection.

Manage Records

Delete Records allows you to delete patient records from the database.

Export Record allows you to export patient records from the database.

Import Record allows you to import records into the database.

Utilities

New Procedure Setup accesses the Procedure Setup page, where you may specify what amplifier inputs will be used and assign them to amplifier channels, specify the order of modes, assign amplifier channels to each mode, and select what types of windows to display during the procedure. For more 69

Elite Operators Manual information, please see Procedure Setup - Overview.

Amplifier Diagnostic is used for diagnosing the amplifier. For more information, please see Amplifier Diagnostics.

Amplifier Calibration is used to check the calibration of the amplifier. For more information, please see Amplifier Calibration. Edit Procedure Setup allows you to access and make changes to procedure setup files. For more information, please see Editing Procedure Setup File.

System Setup allows you to set time bar event marks based on priorities of events and specify where your data files will be stored. You may also add or delete remote servers and set up a message function between the client PC and the Acquisition Cascade. For more information, please see System Setup Overview.

Working with Cascade Windows The Cascade windows environment contains several unique features created to make neuromonitoring faster and data easier to interpret. From within a procedure, the following features and options are available: Mode Windows

Each arrow below indicates a window within a procedure. Each acquisition mode has a set of specially designed windows from which you may choose. Each available window type is identified by its title bar and displays data acquired by that mode in a unique way. This allows you to view the same data in a variety of ways using the window type most appropriate for your needs at any given point in surgery.

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Getting Started - The Basics

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You can have several window types open in Cascade at the same time. You can maximize (enlarge) a window so that it fills the entire desktop and then restore it to its former size and reposition or minimize the window. The name of the minimized window can be viewed in a tool tip text box by placing the mouse over the minimized window. You can move windows around in Cascade and change their size and shape. You only work in one window at a time: the active window. You make the window active by clicking the title bar of that window or by clicking anywhere inside the window. You know that the window is active when the title bar appears highlighted (a darker blue than the title bars of the other windows). Sometimes there is more information than can fit in a window (either horizontally or vertically. When this is the case, scroll bars let you tilt or pan the view to see the hidden information. Mode windows are configured in the window setup dialog for each window accessed from the right-click menu or the procedure setup file. Views

Views are groups of mode windows. Views allow you to preconfigure a set of windows. This gives you the ability to view data the way you want it when you want it with two mouse clicks. You can have twenty unique views, each with a different set of mode windows. Dragging/Resizing Windows

72

Getting Started - The Basics Once you have selected the mode windows you want in each view, you can setup how you want the mode windows arranged and sized. Left-click the edge or a corner of a window and hold it as you drag and resize the window. You can maximize a window by clicking the enabled maximize button in the upper righthand corner of the window. You can restore the window by clicking the Restore button in the upper right hand corner of the window. You can minimize a window by clicking on the minimize button in the upper right-hand corner of the window. Minimized windows are sent to the bottom left of the screen and remain there until restored. The name of the minimized window can be viewed in a tool tip text box by placing the mouse over the minimized window. Right-click functionality

Right-click on a window for a list of menu options available for that window. This list is called a context menu. Auto size

Select this option from the Window menu to automatically adjust the size of all windows concurrently as you resize or move a single window. Lock windows

Select this option from the Window menu to lock all windows in place. You are not able to resize or move windows while the windows are locked. Uncheck this option to release the lock. Locking widows allows more room for data on screen.

Parts of a Window These window options are available after you have started a procedure from the start page. The desktop is made up of four basic parts: the menu bar, toolbar, windows, and status bar. Menu bar:

While performing a procedure or reviewing a procedure, a row of options is displayed across the top of the desktop. This row of options is the menu bar. The items in the menu bar are names of menus. Left clicking a menu name displays a list of commands relating to the name of the menu . To close a menu, left click off the menu option. Refer to the Menus section for detailed information on each of the menu options. Toolbar:

The buttons on the toolbar are a graphical representation of some of the options available from the menu bar. The function of each tool button on the tool bar is described on the status bar (see below) and in the mouse pointer tool tip when the 73

Elite Operators Manual cursor is over the tool button. Please refer to the Toolbar Descriptions section for descriptions of the function of each of the toolbar options. Windows:

Please refer to the Working with Cascade Windows section for more information. Status bar:

The status bar is a bar at the bottom of the Cascade application window that contains status messages. Status bar shows current (clock) time and elapsed time, the name of the procedure setup file being used and computer name and IP address of the computer on the network. Please refer to Cascade Elite Start Page Overview and Starting a Procedure for more detailed information.

Toolbar Descriptions The buttons on the toolbar are a graphical representation of some of the options available from the menu bar.

Save Current Setup

Saves changes you make to the acquisition parameters while running a procedure setup file. Changes may be made in the Procedure Setup window or using the context menu for the individual modes. Choosing the Save Current Setup option will overwrite the procedure setup file. The name of the procedure setup file being used is listed in the status bar at the bottom of the Cascade window. A warning dialog will be displayed asking you to confirm that you would like to overwrite the procedure setup file. To save the current settings as a new procedure setup file, open the procedure setup file and choose save as from the file menu. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if

74

Getting Started - The Basics you print from one EP window, the same template will be used in another EP Window. Current Procedure Setup

Opens the Procedure Setup window to make any changes to the current procedure setup file. Most setting changes can be made while running a procedure without stopping data acquisition. The current procedure setup window must be used to change amplifier settings such as input labels, channels assignments, acquisition sweep, and changing filters, gains, and audio settings. This option is only available when a procedure file is open. Channel Setup

Opens the Channel Setup page of the Procedure Setup window. The Channel Setup page allows you to perform most of the actions that cannot be performed while continuing to collect data such as label the inputs of the amplifier input extender pods, assign the inputs to amplifier channels, name the amplifier channels, and set the filter, gain, and audio settings. Selecting okay or cancel from the Channel Setup window when accessed using this option will return you to the data collection page. View Controls

This set of controls allows you to select views quickly and easily using two command types. The left and right arrows cycle through the views you defined in the setup file. The view label box indicates the current view. The drop-down arrow displays the complete list of views and allows you to choose the view to display. See View Setup for more information on how to set up these views. Lock Windows

Select this option to lock all windows in place. With this option on, the windows cannot be resizes or moved. This prevents inadvertent rearranging of windows and increases the amount of screen space available for wave forms. Select the Lock Windows option again to deselect it and release the lock. Auto Size

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Elite Operators Manual Select this option to resize surrounding windows as you resize or move one window. This option prevents windows from overlapping and makes it easier to arrange windows. Live Mode

The default position for this option is on. When the option is on, the button turns bright green as seen above. This indicates the machine is in live mode. When this option is unchecked, you are in Review mode. In review mode, you can monitor data from earlier in the procedure. The scroll box follows the event markers in the time bar. To exit review mode and return to the current time in the procedure, click the Live Mode button or drag the scroll bar on the time bar all the way to the right. Impedance

This button launches the impedance window. Impedance is the resistance to current flow. It can affect the signals from the recording electrodes. You should check impedance before the start of every recording and during the recording if there is reason to suspect poor between the electrode and the patient. Impedance levels below 5 kiloOhms (kOhms) are acceptable for most tests. The following colors are used to indicate the impedance level for each electrode pair: Green

Yellow

< 5k Ohms

5 - 15k Ohms

Verification Circle

Open Input/bad

electrode Red

> 15k Ohms

Referenced to bad

electrode Go To

This option opens the Events window, in which a list of the events entered for the current procedure is displayed. To go into review mode and jump to the time in the procedure corresponding to a given event, highlight an event and click the Go To button. You may also edit, print or delete events, show event history, and access the procedure records at the time which the event occurred. To exit review mode and return to the current time in the procedure, click the Live Mode button or drag the scroll bar on the time bar all the way to the right. In current mode, the time lapse scroll bar will be gray. In review mode, the time lapse scroll bar will be mustard yellow (as shown).

Auto-Play Review

76

Getting Started - The Basics This buttons launches the Auto-Play Review toolbar and is only available when in review mode. The Auto-Play Review options allows you to automatically play back procedures as recorded or move through a review manually using the Jump to Next/Previous Stored Data buttons. Review mode is accessible by scrolling back along the time bar or clicking the Live button when monitoring a procedure or by opening a previously recorded procedure in review mode.

•

Begin Auto-play by clicking the play button.

•

Select the playback speed using the Speed drop down box to the left of the play button.

•

Jump to the next or previous set of stored data by clicking the Jump to Next/Previous Stored Data buttons. This option ignores events. To jump to the next or previous event, click the left or right arrows at either end of the time bar.

•

Pause playback by clicking the pause button.

Global EP Window

This displays the Global EP Settings window (see Global EP Window). You can change most of the EP window display settings, either for all EP modes or selected EP modes, from this one window. NerveGuard

Opens NerveGuard software. For more information, please see Running NerveGuard. Sync with Server Button

During a remote monitoring session, click on this button to cause the Reader to sync to the same view as that currently displayed on the Cascade. This option is only available when a remote connection is active. This option is only available on the reader system. Help File

Opens the Cascade Help File.

Global EP Window

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Elite Operators Manual This displays the Global EP Settings window, where you can change most of the EP window display settings for selected or all EP modes. These features are also accessible in the right-click menu on EP trace windows.

Setup Reject Info links you to the Setup Reject Info window.

Working With Waveforms Repositioning Waveforms

To reposition waveforms on the screen, resize waveforms, adjust cursor latencies, reset baselines, or create grand averages, you must select the waveform on which you would like to take action. There are various selection and deselection methods using the left click mouse key. Selecting a waveform is different depending on whether or not the Trial Select option is turned on in the right-click menu. With Trial Select Off:

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Getting Started - The Basics To select a single waveform, single-click any waveform. To select all waveforms in a channel, double-click. To deselect all selected waveforms in a channel when all waveforms in a trial are selected, double-click any waveform in the channel. With Trial Select On:

To select all waveforms in a trial, right-click and choose Trial Select (Linked). To select all the waveforms in a trial, single-click any one of the waveforms in the trial once. To select all waveforms in a channel, double-click. To deselect all selected waveforms in a channel when all waveforms in a trial are selected, double-click any waveform in the channel. NOTE: Traces will automatically be deselected whenever a trial is stored for a mode if Trial Select is off for the EP Window. This helps manage waveform selection and deselection.

Resizing Waveforms

The gains of most traces can be resized using the scroll wheel on your mouse. To do this, select the traces you wish to resize and spin the scroll wheel up or down to increase or decrease the size of the waves on screen. All traces in the EEG Window are resized together when none are selected. You may also resize waveforms using the Window Setup option in the right-click menu. Please refer to the Windows Setup section for more information.

Multi-Modal Stimulator Triggering The Cascade surgical monitoring system uses a stimulus trigger table to control the timing of stimuli. An algorithm running on the host computer is used to generate the table and it to the DSP controller in the Cascade base unit. The table is recomputed any time the run status of a mode changes. When the stimulator is triggered at a constant frequency very good cancellation of steady state sine wave noise can be achieved provided the noise frequency is close to an exact harmonic of the repetition rate. The old method of generating multi-modal trigger tables allows the instantaneous repetition rate to vary to prevent collisions between modes while attempting to maintain an average repetition rate which is as close as possible to the requested rate. The new method requires the repetition rates be adjusted so that the instantaneous repetition rate for each mode can remain constant. This can only be achieved by synchronizing the repetition rates for all of the running modes. The following rules are used in generating the table: Rules 1 – 5 apply to both methods

1. Only one EMG mode may run its stimulator at any given time. When the stimulator is started in an EMG mode, an automatic shut down will be performed if a stimulator is running in any other EMG mode. •

Anytime a triggered EMG mode is running at the same time as an EP mode, the EP mode will run at an integer multiple of the EMG rep rate. This means that if the triggered EMG is set to run at 3.11 Hz, the EP will 79

Elite Operators Manual run at 3.11, or 6.22, or 9.33 Hz. If you add another EP mode, it too will run at an integer multiple of the triggered EMG rate. If you then change the rate on the triggered EMG, the rates on the EPs will change. •

The reason for this rule is that triggered EMG modes are used by the surgeon to stimulate delicate neural tissue and are therefore given stim rate priority.

2. An EMG stimulator always runs at the requested repetition rate. •

The Cascade sets the rep rate for the EP as the integer multiple closest to the requested rep rate. For example, if the ABR mode is set to 8.73, the SEP mode is set to 2.87, and the EMG mode is set to 3.11, the Cascade will run the ABR at 9.33 and the SEP at 3.11 because those are the closest integer multiples of the triggered EMG rate.

•

The reason for this rule is that setting the EPs (SEP, ABR, VEP) to an integer multiple of each other assures the best reduction of synchronous noise such as 60 Hz and other periodic noise sources.

3. If the sweep length for an EP mode is longer than the inter-stimulus interval for a running EMG mode, the EP mode will be inhibited and will not run at all until the EMG mode stimulator is turned off. 4. EP mode may be run concurrently. Sweeps are always triggered sequentially and the sweep must be complete before the next mode can be triggered. A fixed interval of 5 milliseconds is added to the sweep interval to allow time for stimulus setup. If a positive sweep delay is in effect, this is also added to the sweep interval. 5. Retriggering the stimulator during a sweep is not allowed when multiple modes are running. This may be done, however; when only one mode is running. Rules 6 – 8 Apply to the "Optimize Random Noise Reduction" Method

6. To avoid sweep collisions when multiple EP modes are running, the repetition rate will be slowed when necessary. The repetition rate is never increased. This is true for the instantaneous peak rate as well as the average repetition rate. 7. When repetition rates must be slowed an attempt is made to maintain equal repetition rate ratios for all modes (except EMG modes). Deviations from precise values occur for two reasons. a) The length trigger table is 128 entries. This sets a limit on the accuracy of repetition rate ratios for any two modes specified in the table. b) The algorithm stops at the end of the table without attempting any adjustments. Two modes having identical repetition rates may not receive exactly the same number of stimuli in the table. 8. The actual repetition rate displayed by the program is an average repetition rate. It is computed by counting the number of stimuli in the table for a mode and dividing by the time required to cycle through the complete table. Rules 9-10 Apply to the "Optimize Synchronous Noise Reduction" Method

9. Repetition Rates are adjusted as follows: 80

Getting Started - The Basics r’m = r’max ÷ n r’m is the actual repetition rate for mode m. r’max is the maximum actual repetition rate. n is a whole number in the range 1 to 16. The value is chosen to minimize the absolute value of the difference r’m – rm rm is the requested repetition rate for mode m. rmax is the maximum repetition rate for all rm rmin is the minimum repetition rate for all rm remg is the requested repetition rate for the EMG mode. In certain cases it may be necessary to adjust r’max to a value other than rmax. If an EMG mode is running with a stimulator on, the EMG repetition rate remg remains fixed and other repetition rates are adjusted as follows: r’max = remg × n n is a whole number in the range 1 to 16 and is chosen to minimize the absolute value of the difference r’max – rmax. If r’max ÷ rm > 16 for any mode the mode will be shut off. In the case where an EMG mode is not running with a stimulator on, r’max is set as follows: r’max = Minimum(rmax, rmin × 16) In either case, if the sweeps for the modes are too long to fit, r’max is reduced as much as necessary to allow time for the sweeps without any overlap between modes. 10. In complex setups with many modes at different repetition rates, it may not be possible to fit the required trigger table into the maximum length allowed. If this occurs, the system will first attempt to resolve this by reducing the number of choices for the value of the repetition rate divisor “n”. If this strategy fails to produce a useable trigger table, modes will be shut off starting with the slowest repetition rate until a usable trigger table is obtained. 81

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Keyboard Accelerator Commands (Hot keys) Up / Down Arrows: Increases or decreases the stimulus intensity of the selected mode control. For standard electrical stimulators, changes occur in increments of 0.10 mA. For the TCS-1 stimulator, changes occur in 2 volt increments. Left / Right Arrows: Move from event to event along the time bar. Page Up / Page Down: Increases or decreases the stimulus intensity of the selected mode control. For standard electrical stimulators, changes occur in increments of 1.0 mA. For the TCS-1 stimulator, changes occur in 20 volt increments. Plus / Minus: Audio volume up and volume down. Ctrl-Space: Smooth all active traces in all EP modes in the current view. Ctrl- C : Enter comment. Ctrl- M : Mute and un-mute the audio. Ctrl- P : Print report. (Same as File | Print). Ctrl- R : All Run and All stop. Ctrl- S : All store. Ctrl- V : Next view. Ctrl- 1 through Ctrl- 0 : Used to the select the first 10 events in the event list. Alt - 1 through Alt - 0 : Used to select the second 10 events in the event list. Esc: Panic key (shuts off all modes, and mutes the audio). Shift+Esc: Resume Run Hot Key: Used to restart the stimulator, data acquisition, and audio for all modes that were running at the time the Esc key was clicked. Ctrl - Shift - P : Sends the image of the screen to the default printer.

Cascade File Extensions These file types are located in the C:\Cadwell\Cascade\Data folder.

File Extension

File Type

.iomdata

v2.6 Patient data file

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.smp

Procedure setup file

.smd

V2.5 Patient data file

.amp

Amplifier input file

.csf

Cursor setup file (cursor setup dialog)

.rtf

Report file

.rpt

Report template file

Getting Started - The Basics .evt

Event list file

.txt

Chat log file

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Cascade Data Management (DM)

Introduction The Cadlink Data Management system is an integral part of managing patients and data recorded by the Cascade software. This new feature allows you to search for a either a record or a patient by name, date, surgeon, or any other data entered into the patient info screen.

Data Management within Cascade Application Starting a new procedure Both record and patient demographics are stored in the data management system. This allows Cascade advanced search capabilities for selecting a record or selecting a patient. After selecting the type of procedure you wish to run, Cascade will request more information about the patient. Patient Creation

As typically surgical patients are not repeat customers, Cascade will automatically ask for new patient information. By filling out this form and pressing OK, you are creating a new patient in the database. Last Name and First Name are required fields.

Patient Selection

If the patient is already in the database, you can re-use the existing patient information by pressing the “Change Patient” button. By re-using patient information, all previously entered patient data is automatically associated with this new recording. The data fields

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Elite Operators Manual below Height and Weight in the Edit Patient Information window are specific to the recording.

The patient selection dialog is a searchable list of all patients. It defaults to showing all the patients and showing all the searchable columns. The search fields are not case sensitive and matches are based on whether or not the field contains the provided value. The “Clear” button provides a quick way of clearing the search conditions and will update the displayed list to show all patients again. A patient can be selected by either double clicking on the patient in the list or by selecting the patient in the list and clicking on the “Select” button. To create a new patient, press the “Create New Patient” button and it will return you to the patient creation dialog.

Procedural Notes Cascade v2.7 and later use data management (DM). With DM the patient information screen is split into two sections. The top portion of the window contains information specific to the patient and stays with the patient in the database for new exams. 86

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The bottom half of the window, Procedure Information is specific to the recording and is populated just for that record. The Procedure information can be filled out when the recording is started, or by clicking on Edit >Patient Info after the recording has started.

Review / Append to an existing procedure When selecting a record to reviewing or append, Cascade now allows you to search for a particular record based on the patient or procedure information that was provided in the “Edit Patient Info” dialog. Record Selection

The record selection dialog is a searchable list of recorded procedures. It defaults to showing all records and having columns for recorded data, patient first name, patient last name, and patient middle initial. All patient and procedure demographics are searchable, and, if provided, will include that field in the displayed columns. A patient is selected by the patient selection dialog. To clear a patient selection, use the red delete button to the right of the patient field. To select a patient, use the browse button to the right of the patient field. These fields are not case sensitive. Matches are based on if the field contains the provided value. The “Clear” button provides a quick way of resetting to no search conditions and will update the displayed list to show all recorded procedures again. A record can be selected by selecting the record in the list and clicking 87

Elite Operators Manual on the Select button. To cancel a record selection, click on the close window button (X) at the top right of the dialog.

Import & Export All files that are tracked by Cascade v2.7 will be shown in the Review Procedure list and the Append To Procedure list. Files not recorded on the current machine can be imported using the Import Record tool and exported using the Export Record tool, each selectable on the main menu.

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Export

Exporting a record brings up the Record Selection dialog. Once a record is selected, the standard Windows Save File dialog will be shown, allowing selection of the destination path of the exported file. The default filename is based on the patient’s name and the date of the record. While the record is being exported a wait dialog will be displayed. This dialog will also be displayed when the recording file is closed indicating the recording is being exported.

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Elite Operators Manual Automatic Exporting

The Cascade software will automatically export records when they are closed. They are exported to the configured patient data folder in System Settings, on the General tab. Their file name is in the format of [last name, First name, recorded date], with a *.iomdata file extension. Import

Importing a record brings up the standard Windows File Selection dialog and allows the selection of both the new file format (*.iomdata) and the legacy file format (*.smd). The import process will pull in all the information connected to the procedure when it was exported, including data files, procedure demographics, and patient demographics. If a particular record is already in the database when trying to perform an import, then the following dialog will be displayed:

This can happen when trying to import a record into the same machine where it was recorded and exported from. Selecting No will cancel the import process and leave the record unchanged. It should be opened for review through Cascade by selecting Review Procedure in the main menu. Selecting Yes will update the existing record with the imported data files and procedure information. It will not overwrite any patient demographics. Chances are the data is exactly the same in the exported file as the record in the database. Importing a legacy data file (*.smd) will bring up the “Create New Patient” screen to allow associating the new record with a patient for the database. This is because the patient demographics cannot be pulled out of old *.smd files like it can be from the new *.iomdata files. The “Select Patient” button can also be selected to associate the *.smd data to an existing patient in the database.

Local Service Control

Cadwell Local Service Control 90

Cascade Data Management (DM)

Status This tool starts up without the need to . The initial screen shows the current synchronization status between the local service and the central service. The central server feature is not available in v2.7. From this screen you can force a synchronization and get a more detailed log. Also you can go into the more advanced configurations of the local service.

Advanced Configuration By pressing the “Advanced” button, you will enter the advanced configuration section. This section of the local service control requires that the provides credentials with the permissions for istrative access. The default name is configured with istrative access. The default is . The advanced window is broken down into four tabs: Settings, File Management, Databases, and Rollback. Each tab contains specific interface related to those sections.

Rollback This tab is used to revert a record back to a previous version of the files. This allows reverting back to a previous version in cases like corruption or other cases relating to data integrity. Select the Patient and click OK or double left click on the patient listing.

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Selecting a record to rollback can be done in two ways; it can be double clicked in the list or clicked on in the list then hit the Select Rollback button. Either method will bring up the version selection dialog.

This dialog allows you to select a version of files based on a list of changes checked into the Cadlink system. Select the desired version in the list and then click OK to accept the rollback. Rollback is done by checking in the specified version over top of the existing version. This maintains the version history adding the rollback as another version.

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Settings There are two groups of settings values; one for the local storage and one for the synchronization with a central server.

Local Storage The local storage is a set of values configured for the data management client being run on the current system. It contains settings for the databases and the file storage for the individual files that comprise a recorded procedure. Database Folder is the location of the data management system patient and procedure detail storage. This can be relocated to a location that can easily be backed up either on the same computer or to a network path location. It is important to make sure the databases shipped with the Cascade software are placed in the specified location otherwise the data management system will not function. Database Search pattern is the filter used in discovering additional databases provided by products or for additional information to be associated to a patient or procedure.

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Elite Operators Manual File Storage Folder is the location of files that are checked into the data management system. These may include the data files, reports, and logs relating to a recorded procedure.

Synchronization and Central Server The Central Server is an additional product that provides for synchronization across a network between several client machines. Central Server URL is the UNC based machine name and port to communicate with the Central Server. Synchronization Interval is the time in seconds between requests for any changes managed by the Central Server. Synchronization Log Capacity is the maximum entries the log will keep, once the maximum entries are reached the oldest entries are removed from the log as new entries are added. Synchronization Batch Size is the number of changes per update that the system should transfer between the Central Server and the Local Server or from the Local Server to the Central Server. This is a useful setting for managing the bandwidth usage of the synchronization. The larger the batch size the more bandwidth will be consumed by the Central Server synchronization. The logging checkbox is used to turn on or off logging.

File Management This tab is used for istration of files on the current local system. There are options to add a file to an existing record, force a file to be checked in, and to force a file’s check out to be undone. All of these options should be used with caution as they can be used to put the record in an unintended state.

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Cascade Data Management (DM)

Add New File This option allows you to associate a new file with an existing recorded procedure. This can be used to associate data with a procedure or to repair a procedure that is no longer associated with the data files. The standard file selection dialog from Windows is used to select the specific file. There is an option to keep the file being added checked out, allowing it to still be locked to the current until later checked in.

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Elite Operators Manual The list of all records is shown with some basic information about the record. Select a record from the list and click the Select button to add the file to the record.

Check In File This option takes the currently selected file and causes the file to be ed to the local service’s data file location and the procedure to be updated with the new version. Any attempts later to check in that file will fail unless it is first checked out again.

Undo Checkout This option removes the current association of the checked out file, leaving the stored file unchanged. Any attempts later to check in that file will fail unless it is first checked out again.

Databases This tab is used to view and print the list of databases currently loaded and being used by Cadlink.

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Cascade Data Management (DM)

Print Database List This produces a print out list stating the name of the system and the current list of loaded databases.

Rollback This tab is used to revert a record back to a previous version of the files. This allows reverting back to a previous version in cases like corruption or other cases relating to data integrity.

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The base display will show all recorded records, but can be filtered using the filter section below the list.

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Starting/Running Procedures Starting a Procedure Open a configured setup file to begin running modes, collecting data and displaying that data in different formats. See Verification of Proper Operation to check equipment setup and operation before beginning any surgical procedure. 1. From the File menu, select Start New Procedure. 2. Select a setup file from the Open dialog box. 3. Click OK. Complete the fields in the Patient Information window. A patient name is required to start a procedure. 4. Click OK. The mode windows display based on how the procedure setup file was configured. For information on how to work in these windows, see Mode Windows Setup Overview. 5. When ready to run the mode controls, click the toggle switch (as seen below under ALL AUTO MODES) or right-click in an EMG or Average window and select Run, for a specific mode or for all modes. NOTE: Click the Run button in the All Auto Modes section to turn all auto modes on and, click it again to turn all modes off.

6. To make any changes to the procedure setup for certain conditions (i.e. electrodes falling off), go the Edit menu, and select Current Procedure Setup. Make any necessary changes to the amplifier inputs, modes, channels, or views. Click OK to close the Procedure Setup window. 99

Elite Operators Manual NOTE: Right-click on EMG and Average windows, and select Mode Setup or Window Setup to access frequently changed parameters.

To start a procedure using a TCS (TCS-1, TCS-1000, or TCS-4) 1. With the Cascade and TCS plugged-in and setup for monitoring, choose the 'Start New Procedure' option from the File menu on the main Cascade page. 2. Double click the name of the procedure setup file you want to use from the list and enter the patient information. You will need to enter at least a first and last name. Patient information may be changed or updated later. 3. Click OK to start recording. 4. Check impedance of the recording electrodes by clicking the icon with a "Z" on it on the toolbar at the top of the screen. When you are satisfied with the impedance levels, close the impedance window. 5. You are now ready to record transcranial electric motor evoked potentials.

TCS Stimulus Triggering Triggering the TCS-1/TCS-1000/TCS-4 stimulator in the MEP mode type may be achieved using the Single Trigger button in the Mode Controls window. For EP and EMG mode types, the TCS-1/TCS-1000 stimulator may also be triggered using the mode’s Run or Single buttons (Fig 6).

NOTE: Right clicking over the MEP trace window can also access The Single Trigger, Run, and Single functions.

When a TCS is triggered, the voltage/current value will momentarily flash ‘yellow’ within the Mode Controls window (Fig 7) and the Cascade software will display the resulting waveforms in the appropriate mode window replacing all active waveforms displayed. The active waveforms are erased upon triggering a new trial unless the data is stored before triggering occurs. Data may be auto stored or manually stored.

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Starting/Running Procedures

When a TCS is triggered, the voltage/current value flashes yellow.

TCS Stimulus Intensity Adjustment Stimulus intensity (voltage) is adjusted using the stimulus intensity knob in the Mode Controls window. Each mode using the TCS-1/TCS-1000/TCS-4 stimulus type contains a single intensity knob in the Mode Controls window. The delivered intensity is adjustable in two-volt increments from zero to the pre-set maximum (as defined by the in the Setup Stim dialog or the Mode Setup dialog) using the stimulus intensity knob. The stimulus intensity may be adjusted up or down in 20 volt increments using the “Page Up” and “Page Down” keys on the computer keyboard, similarly the up and down arrow keys can be used to adjust in 2 volt increments. The “Home” key on the computer keyboard will return the stimulus intensity knob to zero.

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Single Train Stimulus

Double Train Stimulus

Charge Accumulation Recommendation Charge accumulation popup reminds to keep current at levels that are less likely to cause tissue damage. The popup appears as you increase the stimulation amplitude during a procedure. The scale of the popup is in Coulombs/hour, and is a function of the stimulus amplitude, pulse width, rep rate, and stim ON time. Electrodes with smaller surface areas are more likely to cause charge accumulation-related tissue damage. The popup serves as a recommendation and disappears automatically after 3 seconds. The popup does not appear for modes with biphasic stimulator(s). There is also a check box to "Never show me this again" if it is desirable to keep the box from appearing at all.

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Checking Impedance Impedance is the resistance to current flow. It can affect the signals from the recording electrodes. Check impedance before the start of every recording and during the recording if there is reason to suspect poor between the electrode and the patient. Checking Impedance also resets the amplifiers. Impedance measurements are automatically saved in the data file. Upon review, the impedance measurements can be re-displayed by going to the Impedance Event (use the Go To feature in the Event menu), then clicking on the Z toolbar button. You can check electrode impedance at any time during a test. In order for the impedance routine to work properly you must have at least two Active, two Reference, and one Ground electrode connected to the amplifier (5 electrodes). Impedance levels below 5 kiloOhms (kOhms) are acceptable for most tests. The following colors are used to indicate the impedance level for each electrode pair: Green

< 5k Ohms

Yellow

5 - 15k Ohms

Red

> 15k Ohms



Bad Electrode

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Bad Reference

To check electrode impedance 1. Make sure the amplifier is on and electrode leads are inserted into the amplifier jacks. The ground electrodes must be connected. The Cascade Elite & Pro systems require two ground electrodes; one for each amplifier. Pods A & B require one ground. Pods C & D require one ground. 2. Click the Impedance button

on the toolbar to display the impedance box.

3. Make sure the appropriate channels are turned on in the procedure setup file. The Cascade impedance algorithm introduced in v2.2 looks at all channels used in any montage for the calculation. Version 2.3 and later allows s to deselect channels they do not connect to the patient for that recording, allowing the to get an accurate impedance calculation. Simply right click on the pod you want to exclude channels from, uncheck the boxes for those channels to be removed from the impedance calculation. Then click OK. This will exclude those inputs from the impedance calculation for the remainder of the recording.

4. When the indicator is displayed next to an impedance value Cascade is indicating that there is not enough information for it the value displayed is accurate.

When you get a reading with a high impedance

this is most likely value and the indicator is displayed next to it, a bad or disconnected electrode. When you get a reading with a low impedance this is most likely value and a indicator is displayed next to it, an electrode that has lost it’s reference electrode in the impedance calculation. . The Such a reference electrode would display an impedance of electrodes with the high impedance listing and the indicator displayed next to it should be replaced or reapplied first then the impedance test should be executed again. Even though the robust impedance algorithm has redundancy built in for references and grounds if too many electrodes are bad or unplugged 104

Starting/Running Procedures the indicator lets the technician know the Cascade system does not have enough information to display an accurate value for those inputs. Also make sure to deselect any inputs not connected to the patient. 5. To close the impedance box, click Quit. Please see Impedance Test Arrays for more information on testing the impedance of your hardware.

Averaging Waveforms Averaging is used when the amplitude of the response is small. Signal averaging helps to define the response and pull it out from the background noise. The epoch of data following each stimulus is averaged point-for-point to produce an averaged waveform. Deflections that are time-locked to the stimulus are reinforced, while signals that vary randomly with respect to the stimulus are reduced.

The final averaged response is based on the number of stimulus presentations that you set. When the test has collected the given number of sweeps, it automatically stops the averaging and displays the final waveform. Every sweep of the averager starts with the presentation of a stimulus. However, when reject is being employed, every sweep might not be included in the actual average. The reject function detects the condition when the input is larger than an allowable range. Under these circumstances, the input is peak clipped and therefore distorted. When the artifact reject function detects the input over-scale condition, it does not allow the sweep to be included in the average. This means that when the average is completed, more stimulations might have been delivered than total sweeps in the average.

To turn averaging on and off By default, to begin averaging and evoke potential mode, click the Run/Stop toggle switch. To stop averaging, click Run/Stop again.

To store averaging You can store traces from the averaging both when the averager is running and when it is stopped. If the averager is already running when data is stored, it is cleared and continues to run after the store operation is complete. Averaging might be temporarily suspended to ensure the integrity of the stored data. To store the averaged waveforms, right-click on the Average window, and click Store.

To clear and reset averages

105

Elite Operators Manual You can clear the averager both when it is running and when it is stopped. If you clear while running, the data is cleared, and the averager continues to run. If you clear while it is stopped, the active waveform is cleared, and the averager resets to zero. Right-click on the Average window, and click Clear to reset the average count to zero.

Pause Averager There are some testing procedures such as clinical testing where it is advantageous to pause the averaging of responses while leaving the stimulator running. To do this, choose the Pause Averager option from the right-click menu of any EP mode. When checked on, the Pause Averager option pauses the averager while allowing the to control the stimulator as normal. The default state is for the Pause Averager option to be unchecked. When the Pause Averager option is selected on, the Average count in the Mode Control Windows and in the Date windows will show “Paused.” The mode will remain in Pause Averager mode until the option is unchecked.

Electro-Surgery Detector and Electro-Surgery Reject

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By monitoring the activity of electro-surgery devices, the ES Detector: • Mutes audio during use of electro-surgery devices • Stops "Store on Auto Capture" function • Pauses the EMG stimulator

Using the ES Detector On the hardware:

1. Attach the ES Detector to the base unit using an auxiliary cable. 2. Attach the ES Detector Clip to the ES Detector's Channel 1 port. If two Electrosurgery devices are being used, attach a second clip to the Channel 2 port. 3. Run all Electro-surgery hand piece lead wires from one Electro-Surgery device through the gap in the ES Detector Clip. If two ES devices are being used, run all ES hand-piece wires from the second ES device through the second ES Detector Clip. Within the Cascade software:

1. Edit the Procedure Setup, a. Within the Mode Settings section, "General" is selected from the Setup drop-down menu. b. Checkmark the Bovie Mute option. c. Click the OK button to close the Procedure Setup file. 2. In the View menu option, select Reject Settings...

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Elite Operators Manual a. that the reject sensitivity sliders on Channels 1 and 2 are at the lowest settings. b. Click the Done button. 3. Continue with electro-surgery procedures.

Access Mute Audio Settings To access EMG Mode Setup and adjust mute audio settings, go to the Mode Settings section of the Procedure Setup window for an EMG Mode Type, and select the General Setup. These options may also be accessed during a procedure by right-clicking on the EMG trace window and selecting Mode Setup

Channel 16 Mute Audio Enable Channel 16 Reject: This amplifier channel can be used as a reject channel. Select this option for EMG mode type in the Procedure Setup file to pause all data collection and mute the audio when the data on this channel exceeds the threshold. When deciding where to record from for channel 16, choose a site off of the torso and away from the muscle being recorded for EMG.

Bovie Mute Audio Enable Bovie Reject: Up to four electrocautery detection probes can be connected to detect the use of a Bovie device. Select this option so that data is not collected during periods of electrocautery use.

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For more information, see Setup Reject Info.

Adjust Mute Audio Sensitivities To access the sensitivity of Channel 16 and Bovie mute audios, click View in the toolbar, and select Reject Settings. Adjust the sensitivity by sliding the threshold slider up or down for each channel. If you do not have any activity in the channel 16 reject settings or the activity is larger than full scale, adjust the amplifier gain of channel 16 in the procedure setup. Increasing the gain will reduce the level seen in the reject settings.

Working with Cursors Auto cursors are used in the EP modes to label waveforms with latency and amplitude measurements. You can define separate cursor setups for each mode in the Setup dialog. You can change the defaults to meet individual testing needs. You can have up to sixteen individual cursors for each EP mode. You can apply auto cursors during or after waveform acquisition. If placed while data is being acquired, they remain in that position regardless of changes in the waveform’s

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Elite Operators Manual shape as additional sweeps are collected. You can manually position waveforms to any location on the graticule. Click Store to record waveforms in the patient file. •

To view or hide cursors, right-click on the Average window, and check or uncheck the Show Cursors option.

•

To move cursors, use the mouse pointer and drag the cursor across the trace.

•

Auto Place Cursors: If no traces are selected (yellow) then cursors are automatically placed on the live traces (white). Otherwise they get placed on the selected trace. Right-click on the Average window, and check the Auto Place Cursors option.

Self Adjusting Latency Ranges for Auto-Cursors: The Cursor Setup table in the procedure setup file can be quickly and easily adjusted while collecting data without using the procedure setup file. 1. Select the Autoplace Cursors option in the right click menu to place cursors on your waveforms. 2. With the Trial Select option selected on in the right-click menu, select a trial in the EP Average window. Be sure that only one trial is selected (only one waveform per channels is selected) 3. Adjust the latencies of the cursors on the waveforms to the correct latencies by dragging and dropping the cursors with your mouse. 4. Click the Adjust Latency option from the right-click menu. The start and end latency values for all cursors will be adjusted to +/- 10% of the current positions of the auto-cursors with the midpoint located at the latency that the cursor is placed at.

Setting Baselines Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected.

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Starting/Running Procedures As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline.

Changing Settings for Multiple Modes Click the EP button on the top toolbar to access Global EP Setup.

From the Global EP Settings window, you can change most of the EP window display settings, either for all EP modes or selected EP modes.

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Side-by-Side Comparison of Current and Past EEG Splits the Live EEG window into two sections. The section on the right will continue to show the live EEG traces. The section on the left can be used to review back through the EEG by using the horizontal scroll bar. The dividing line between the two sections can be dragged to increase or decrease the size of either section. The Elapsed Time is indicated at the top left of the review section.

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Paging Toolbar Use these toolbar buttons to go forwards/backward by one page or one division within the review section.

Appending to a Procedure This feature allows s to append additional data (traces) to an existing data file. Typical usage of this option would be when a pre-surgery screening was done before the patient enters the operating room.

To make changes to an existing procedure file 1. From the File menu, select Append to Procedure to display the Open dialog box. 2. Select the data file you want to edit, and click Open to display the views. 3. Make any necessary changes to the procedure file, such as patient information, current procedure setup, event list, comments, or to append additional data.

System Clock Error To help prevent data file corruption Cascade will display the following error message when it detects that the system date and/or time has been changed since the recording has started. The message is triggered when an Event is entered such as stored EP trials or a comment if the system clock or date has been changed by the since the recording started. .

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When this message pops up it is recommended that you close this procedure and start a new file. The message will only pop up once in the same recording file. The message will not stop the recording or keep the from adding events. If a new file is not started when the message appears the s runs the risk of having a corrupted data file that cannot be opened and reviewed later.

Exporting Data You may output a waveform in a numeric format (ASCII) for analysis and research. This option is available in EP Average, Waterfall, Summary and EMG Stack windows. To generate an ASCII format of one or more live or averaged waveforms from an EP Average window, simply select the waveform(s) you wish to output to ASCII format, right click and select Output Traces to ASCII. A Save As dialog will open allowing you to specify where to save the file and what name to give the file. The ASCII file can be opened using any program that can handle comma separated values (.csv) file types.

To generate an ASCII format of one or more averaged waveforms from a Waterfall, Summary or EMG Stack window, select the trials or trial you wish to export then right 114

Starting/Running Procedures click on the window. It is not necessary to select a trial or trials. The export dialog will give you the option to export all trials. In the ASCII Output dialog, name the file you wish to create, choose a save path, chose your options and choose your trace selection then click Save Traces.

The default file name prefix gives you three indicators to help identify the CSV file: an abbreviation for the window type, the mode name and the channel name. Following the filename prefix in the stored filename is a time stamp with the date and time. When exporting from a summary window or EMG stack window, a separate file will be created for each channel. A separate ASCII Output dialog will be presented for each channel. The three check boxes in the Options group allow you to 1. Include a column in the CSV file to label the fields 2. Include a history of the stimulus delivered for each trial 3. Select how you would like the columns and rows formatted. The Trace Selection option allows you to categorically select which traces to output. The Selected traces option will only output those traces that are highlighted in the window. The All traces showing in window option will only output the traces showing in the window regardless of whether they are selected. The All recorded traces option will output all traces for the entire window including those from an earlier or later time period not shown in the window.

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Cascade Noise Reduction Options To reduce noise from electrical noise sources: Use the ES Detector (Electro-Surgery Detector and Electro-Surgery Reject). Check all cable connections. •

Make sure there are no bent pins in the amplifier cable and the input extender cables.

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Make sure all cables are securely connected.

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See Elite Base Unit Connections

that the Procedure Setup is correct. •

Make sure that the appropriate amplifier inputs are assigned to the channels in the test montage.

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Make sure that the channels from the test montage have been assigned to the acquisition modes correctly.

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that the appropriate gain and filter settings are being utilized.

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that the appropriate sweep speed is being utilized for each acquisition mode.

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Delete unused channels from the test montage.

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See Procedure Setup

Check Electrode Impedances. •

Make sure all electrode impedances are below 5k Ohms and are well balanced.

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See Checking Impedance

Location of Ground Electrode. •

Each amplifier requires one ground electrode on the patient. Because the Cascade Elite has two amplifiers, it requires the use of two ground electrodes. The ground electrodes should be plugged into the ground jack on the amplifier input extender pods. Place one ground electrode on the patient’s head near the evoked potential recording electrodes. Place another ground electrode on the patient near the majority of electrodes for that amplifier.

Twist Lead Wires together and bundle. •

Try to twist the electrode lead wires together and bundle all of them together if possible. For example, twist and bundle the SEP electrode leads together, and do the same for the EMG leads from the Left leg and Right leg.

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Try to use short electrode lead wires in combination with the input extender cables.

Position main Amplifier.

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Move the amplifier away from potential noise sources. Moving it 1-2 feet from its current location can sometimes make a difference.

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Moving the electrode lead wires a few inches can also make a difference.

Starting/Running Procedures Check grounding of Laptop or desktop PC and Cart. •

Make sure that the Laptop or desktop PC is grounded. A wire should be attached from the Laptop or PC to the ground connector on the back of the Cascade base unit.

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If the Cascade is sitting on a metal cart, use a second wire to ground the cart to the same ground connector on the back of the Cascade base unit.

Connect power directly to wall outlet, by power strips or isolation transformers. •

If the Cascade’s power cord is plugged into a power strip or isolation transformer with other devices, try plugging the Cascade directly into the wall outlet.

Determine the Frequency of the Noise

A. If the noise is 60 Hz, try using the Notch Filter. B. Change the Repetition Rate to an integer multiple of the noise source plus an additional ½ period. See explanation that follows. To Determine the Frequency of the Noise (additional methods are found in Determining Frequency of Noise):

1. Right click on one of the EP Average windows. 2. Select the LIVE option from the pop-up menu. 3. Stop the mode so that the LIVE trace will be frozen within the window. 4. Right click on the window again and use the Time Marker option to place two vertical time markers on the window. 5. Place the markers so that you can measure the Peak to Peak interval of the noise. 6. Divide the resulting Peak to Peak interval (in milliseconds) into 1000. The result is the frequency of the noise. The following two examples illustrate this for 60 and 180 Hz noise.

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To Determine the Optimal Repetition Rate to Use:

Mathematical modeling shows that the best repetition rate to use for steady state noise is one that when divided into the noise frequency results in an integer multiple of the noise source plus an additional ½ period (i.e., 0.5). For example, if you use a repetition rate of 2.72 with 60 Hz noise: 60 / 2.72 = 22.059 This would not be a good repetition rate to use. But, if you use a repetition rate of 2.79 with 60 Hz noise: 60 / 2.79 = 22.505 This would be a good choice to use since the result is almost exactly an integer plus 0.5. When using the wrong repetition rate the noise will wax and wane during averaging. That is, it will start to average out and then will appear to grow back into the response. When using the correct repetition rate the noise should progressively be reduced during averaging and should not return. The following tables list some suggested repetition rates to use with varying frequencies of noise. You can obtain a complete Excel spreadsheet of

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Elite Operators Manual repetition rate vs. noise frequency by ing Cadwell (see also Choosing Appropriate Repetition Rate).

Use the Digital Smoothing Filters •

Right click on the EP Average window and select Mode Setup. Try applying the Digital Smoothing filters in the order that they are listed. The SF filters remove high frequency noise from the traces, SF1 the least amount, SF5 the most. The ABR1 and ABR2 filters are designed to specifically enhance the peaks of the ABR response.

Change the system to the “Optimize For Synchronous Noise Reduction” stimulus triggering mode. •

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From the Edit menu select System Setup. On the General tab select the option Optimize For Synchronous Noise Reduction. Click OK. You will need to stop and restart all data acquisition after making this change.

Starting/Running Procedures •

Again, determine the frequency of the noise source and choose an appropriate repetition rate. NOTE: There are more restrictions on the attainable repetition rates when using the Optimize For Synchronous Noise Reduction triggering mode.

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Try to start and stop all running modes synchronously, it may help to use the Synch Start 1 setting in the Run Mode field.

Choosing The Appropriate Repetition Rate 60 Hz The following table is a reference on repetition rates you can set to eliminate specific frequencies of noise and harmonics of that frequency. To eliminate noise contamination in your signal, first determine the frequency of noise. Set the stimulus repetition rate to one of the values listed in the following table under the appropriate frequency. NOTE: The FFT marker in Reject Settings can be used to determine the dominant frequency in any EP channel. See Determining Frequency of Noise.

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Determining Frequency of Noise The FFT marker in Reject Settings can be used to determine the dominant frequency in any EP channel. 1. While running a procedure, click on the Global EP Setup icon

2. Click Setup Reject Info

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3. Select a channel to view 4. Click and drag the grips to define reject area 5. At the bottom of the Reject Settings window, click and drag the FFT Marker to the peak of the dominant waveform 6. To determine the stimulus repetition rate which eliminates noise from your signal, cross-reference the frequency of noise found with the FFT Marker to the Noise Frequency vs. Repetition Rate table in the Choosing Appropriate Repetition Rate section.

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Using Menu Options File Menu Start New Procedure Opens the Procedure Setup File dialog box, where you select a procedure setup file for surgery, enter patient information, and begin running modes and monitoring data.

Append to Procedure

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Elite Operators Manual Opens the Cascade Data File dialog box, where you can select an existing data file and append additional data (traces) to that file. This feature is often used if a presurgery screening was completed before the patient entered the operating room.

Review Procedure Opens the Cascade Data File dialog box, where you can select a patient data file for viewing information. Use the arrows on the time bar to jump to events in the data file. Data is displayed for that time during the surgery. That is, you can move around in the file and review the trends, video, and trace data at any time during the surgery.

Close Procedure Closes the procedure windows that you are viewing. This option is only available if you have a procedure file already open.

Save Current Setup Saves changes you make to the acquisition parameters in the procedure setup file, typically when you start a new procedure and make changes using the Edit Current Procedure Setup. You can save these changes to the original setup file.

Create New Procedure Setup File Opens the Cascade-Procedure Setup window, where you can set up a procedure file before surgery. You specify what amplifier inputs will be used and assign them to amplifier channels, specify the order of modes and assign amplifier channels to each mode, and select which types of windows to display during the procedure.

Edit Procedure Setup File Opens the Procedure Setup File dialog box, where you can select an existing setup file that you want to edit or review.

File Names Displays a list of the four most recently viewed files. Each file name is unique and generated by the system with the patient’s name, and the date and time the file was created.

Exit Exits the Cascade application. NOTE: When running a procedure, the Print Report and Print Screen options are available from this menu.

Edit Menu

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Patient Info Opens the Patient Information form, where you can edit patient information, such as patient name and ID, procedure information, such as surgeon and assistant names, and diagnosis.

Current Procedure Setup Opens the Procedure Setup window to make any changes to the current procedure setup file. This is used for certain conditions, such as when electrodes fall off. You can make any necessary changes to the amplifier inputs, modes, channels, or views. This option is only available when a procedure file is open.

View Setup Opens the View Setup dialog box, where you can change the composition of existing Views or create new Views. This allows you to change the procedure’s Views without having to stop the procedure and enter the Edit Current Procedure Setup window.

System Setup Opens the System Setup dialog box, where you can set up time bar event marks based on priorities of events, and allows you to specify where your data files will be stored. You can also add and delete remote servers, and set up a chat box that is used to send messages back and forth between the client PC and the Acquisition Cascade.

Amp Input List Allows you to edit the pop-up list of commonly used input labels. Right click to insert or delete entries from the list. Use the Move Up/Down arrows to change the order of the labels in the list.

View Menu Most of these menu options are only available when a procedure file is open.

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Status Bar Displays or hides the status bar at the bottom of the screen. A check mark appears next to this command when the status bar is active. This software application uses the status bar to display information messages.

Live Mode When this option is unchecked, you are in Review mode, where you can monitor data from earlier in the procedure. The scroll box follows the event markers in the time bar. When this option is checked, you are in live mode, where you can monitor current data. The scroll box is set at the far right of the time bar.

Reject Settings Displays the Reject Settings Window where you can monitor and adjust the thresholds for the Channel 16 reject and the four Bovie Reject detection lines. Red lights indicate that the activity in that line is causing the system to stop data acquisition and speaker output. Green lights indicate the line is detecting activity that does not exceed the reject level, and the system will acquire data and output to the speaker. A yellow indicator displays in the Mode Control area for as long as any rejection is occurring. Channel 16: this amplifier channel can be used to pick up excessive noise or electrocautery and, when the threshold is exceeded, will cause the Cascade to pause all evoked potential data acquisition and will mute the audio for the duration of the reject condition. Bovie Channels: up to four detector probes can be placed inline with the electrocautery unit power cord. When the unit is in use and the threshold is

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Starting/Running Procedures exceeded, the Cascade will pause all evoked potential data acquisition and will mute the audio for the duration of the reject condition.

Next View Cycles through the views you defined in the setup file. See View Setup for more information on how to set up these views.

View Selection The items at the bottom of this menu are the names of the views from your setup file. The radio mark shows which view is currently selected. Selecting any of these items takes you to the corresponding view.

Test Menu Tests define an Amplifier setup or Montage. Multiple Tests can be used in order to reduce the DSP Utilization of each test. When you switch tests, you are changing the amplifier setup (montage) and the available acquisition modes that have been enabled for the test. You must have more than one test set up for this menu option to be enabled. This menu option is only available when a procedure file is open.

Next Test Cycles through the tests you defined in the setup file.

List of Tests Displays the list of tests you defined in the setup file. Select a test from the list to view that test. A radio button displays next to the test that is active.

Remote Menu

Connect to Cascade (Server) 135

Elite Operators Manual Displays a list of Cascade servers (i.e., Cascade Acquisition Stations), and allows you to search for and connect to a Cascade server to begin remote viewing of monitoring a surgery.

Disconnect Disconnect from the remote computer.

Connect to Reader (Client) Displays a list of possible Client computers (i.e., Cascade Remote Reader Stations), and allows you to search for and connect to a Remote Reader to begin remote viewing of the surgery.

Sync with Server Button During a remote monitoring session, click on this button to cause the Reader to sync to the same view as that currently displayed on the Cascade. Show Chat Toolbar Hide or show the remote monitoring chat toolbar. Reset Chat Window Sends the chat window to the upper left corner of the monitoring screen. This is useful if the chat window is hidden behind windows or is positioned off screen.

Client List Displays a list of remote "viewing" computers that are currently connected to a Cascade server by their computer name.

See also: Remote Monitoring Connection Scenarios

Events Menu This menu option is only available when a procedure file is open.

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Event List The event list is created in the procedure setup file as a list of possible events that will be encountered during surgery. This list is an example that might be used. Select an option from this event list to enter it in the Event Window. The current time and most recent traces are also entered in the Event window when you select an event.

Comment Opens the Event Log where you can enter comments and select a priority of the comments. The time and date is entered automatically when you enter comments.

Go To... Opens the Events window where you can select an event, click the Go To button, and view data at that event.

Edit Event List Opens the Events window where you can modify the priority of each event in the event list, or reset the list to its default values.

Window Menu This menu option is only available when a procedure file is open.

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Lock Windows Select this option to lock all windows in place. You are not able to resize the windows or move them while they are locked. Select the Lock Windows option again to deselect it and release the lock.

Auto Size Select this option to resize surrounding windows as you resize or move one window, in order to continue to view all of the windows concurrently.

Cascade This command displays all open windows on the screen in a cascading order.

Tile This command displays all open windows on the screen as the same size of window.

Active Window This list displays all open windows on the screen. The checked window name is the active window. You can also make a window active by clicking the title bar on the window or anywhere in the window. You know that the window is the active one because the title bar appears highlighted (darker than the title bars of the other windows).

Help Menu

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Cascade Help Topics Displays the Cascade 16 channel system help file. 138

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Cascade Elite Help Topics Displays the Cascade 32 channel system help file.

About Cascade... Displays the hardware, software and firmware versions of hardware components as well as copyright information.

Running NerveGuard NerveGuard Introduction NerveGuard is an extension of the Cascade’s triggered EMG modality and provides a convenient and easy-to-use interface for automatic pedicle screw stimulation, threshold determination, and documentation. You can perform a complete pedicle screw testing protocol in NerveGuard. For example, you can use the Continuous Mode during pedicle probing and taping as an early warning of a low threshold; use the Fixed Mode to stimulate the pedicle feeler as the surgeon feels the inside of the pedicle; use the Continuous Mode again as the surgeon drives the screw with the screw driver; use the Screw Threshold mode to determine the threshold of the screw when in place. NerveGuard displays triggered EMG activity during screw stimulation and automatically switches to free-running EMG during periods of no stimulus delivery.

NerveGuard Operation Follow the steps below to run NerveGuard. See NerveGuard Procedure Setup for setup instructions. 1. Start the Cascade program and begin a procedure in the normal fashion. 2. Start NerveGuard by clicking on the NerveGuard icon in the main Cascade toolbar. 3. Carefully read the contents displayed in the NerveGuard Checklist window: • Electrode Placement Recording electrodes must be placed in muscle groups corresponding to then pedicle screws being stimulated. Incomplete coverage of myotomes may result in inaccurate testing and/or excessive stimulus intensities. • Muscle Relaxant Patient muscle relaxant levels must be low enough to allow for repetitive evoked EMG activity. Complete or partial muscle blockade may result in

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Elite Operators Manual inaccurate testing and/or excessive stimulus intensities. A Train of Four test may be used to measure muscle relaxant levels. • Detection Thresholds EMG thresholds must be set at levels that will accurately detect evoked EMG activity. Evoked responses below the detection thresholds will not be detected and may result in inaccurate testing and/or excessive stimulus intensities. • Stimulator Setup The stimulating probe (cathode) and the return (anode) must be intact and properly connected to the stimulator box. An incomplete circuit will result in a failure to auto start stimulation. • Current Shunting Appropriate measures must been taken to prevent current shunting. The surgical field should be dry and all muscle and soft tissue should be retracted off of the pedicle screw and stimulating probe. 4. Click OK. The main NerveGuard window will be displayed. Click Cancel to abort NerveGuard. NOTE: The Show options Always or Once, displayed at the top left hand corner of the NerveGuard Checklist window, indicates whether the checklist window is displayed every time NerveGuard is started or only the first time it is started on each patient.

5. NerveGuard begins in free-run mode. The data window displays the text "FreeRun" in the upper left corner of the data window. The free-run data window has the same options as in the standard Cascade including right-click functions. 6. Click the Control button labeled "Click to Activate Autostart" to enable Autostart. With NerveGuard in Autostart mode, the system will switch to triggered-EMG when the surgeon touches the probe to the patient. 7. When the probe is lifted from the patient, NerveGuard will automatically switch back to free-run mode.

Determination of Threshold Screw Test Mode A stimulus threshold value is achieved when an above-threshold triggered EMG response is captured three times consecutively for the lowest intensity at which the EMG waveform is above threshold

Continuous Mode

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Starting/Running Procedures The intensity increases until a triggered EMG response is captured, at which point the intensity decreases until the response is lost. The stimulator intensity then increases until the response is captured again. This process repeats as long as the mode is active and current is flowing (it will stop when “High Z” is detected).

Performing Pedicle Screw Threshold Detection Outline of Steps: 1. Confirm that ‘Screw Test’ detection mode is selected. 2. Confirm that the Audio Controls are configured appropriately. 3. Click on the Spine Graphic to choose the level & side. The selected region will be colored in grey. 4. Click on the Control button to change from Standby mode to Ready To Stimulate mode. 5. Have the surgeon touch the stimulus probe to the pedicle screw. The High-Z indicator should clear automatically and the program will change from free running to triggered EMG. 6. The stimulus intensity will automatically increment at the steps defined in the Setup window. 7. When the threshold level is detected, the stimulus intensity will automatically return to the starting point and the threshold value will be indicated (in green, yellow, or red background) in the Control button area. The text “Threshold Detected for side & level” will be shown and if the Threshold Tones check box is enabled, the threshold tone will be played. If no response is detected at maximum stimulus intensity, the letters "NR" will be shown. A unique audio tone will be presented when a threshold is found or no response is reported. 8. Have the surgeon remove the stimulus probe from the pedicle screw, the High-Z indicator will return and the program will switch back to free running EMG traces after about 1 second. 9. Choose next level & side to be stimulated by clicking on the Spine Graphic. 10. Repeat steps 5 through 8 to test the next screw.

Returning to Standby mode: To return to Standby mode, click on the Control button.

Using Continuous Stimulation Mode Although it can also be used during fusion procedures, continuous mode is typically used during screw hole tapping, pedicle screw placement, or when persistent stimulation of surgical instruments and response detection is desired. In continuous mode, stimulation does not stop when a threshold is detected. Instead the system continues to track the changing threshold levels.

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Outline of Steps: 1. Set the Detection mode to ‘Continuous’. 2. Confirm that the Audio Controls are configured appropriately. 3. Attach the stimulus cable to the surgical probe or instrument. 4. Change from Standby mode to Ready To Stimulate mode by clicking on the Control button 5. Continuous stimulation and threshold detection begins when the probe makes with the patient and the High-Z indicator is not shown under the Intensity scale. 6. When the EMG activity exceeds threshold settings, the program will indicate the threshold value (in green, yellow, or red background) in the Control button area. The text “Threshold Detected” will be shown with the stimulus intensity that generated the response. If the Threshold Tones check box is enabled, the threshold tone will be played. 7. The program will continue to stimulate and will continuously monitor for threshold activity and update the threshold value. 8. To return to Standby mode, click the Control button. NOTE: The Spine Graphic is typically not used in Continuous mode.

Using Fixed Detection Mode The Fixed mode is used to deliver a fixed intensity to a probe or surgical tool. To use the Fixed Detection Mode in NerveGuard, select the Fixed Detection Mode button in the upper right corner of the NerveGuard window, set the intensity slider to the desired intensity and click the Control Button to turn off standby. The intensity slider can be controlled by dragging the slider on screen using the mouse, using the up and down arrow keys on the computer keyboard and by rolling the scroll wheel on your mouse. The control button displays in real time the actual stimulus intensity being delivered. If no evoked EMG is detected, the background of the control button is gray. When an evoked EMG is detected, the control button displays the color corresponding to the stimulus intensity as set in the NerveGuard setup. If Threshold Tones are turned on, your computer will play the tone corresponding to the stimulus intensity delivered. Evoked EMG events detected in Fixed Detection Mode are logged and displayed in the pedicle screw stim report. Waveforms are stored only if the Store on Autocapture option is turned on in mode setup.

Making Changes During Testing Changing NerveGuard Setup:

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Starting/Running Procedures To change NerveGaurd settings such as Stimulus Start Intensity or Threshold Intensity Color Scales, click on the Setup button in the NerveGuard window. Refer to page 12 for a description of the available settings.

Adjusting Threshold Settings NerveGuard determines a threshold value for a pedicle screw by monitoring for EMG activity that exceeds a preset value. This value, or threshold setting, is set in microvolts for each EMG channel being recorded. As such, EMG thresholds must be set at levels that will accurately detect evoked EMG activity. Evoked responses below the detection thresholds will not be detected and may result in inaccurate testing and/or excessive stimulus intensities. By the same token, baseline EMG activity or stimulus artifact that is above the detection threshold levels will result in inaccurate testing. To adjust the EMG threshold levels, follow these steps: • Right click over the EMG trace area. • Select the General submenu from the Mode Setup from the context menu. • Click on the Setup Thresholds button. • Adjust the threshold levels for each channel. • Click OK See the section on EMG Threshold for more information.

Changing Stimulus Settings (rep rate, pulse width): To change stimulus settings, right click over the Trace Area and select NerveGuard from the Mode Setup submenu list. Make the desired changes and click OK.

NerveGuard and Remote Monitoring NerveGuard automatically opens, runs, and closes on remote reader system when the Cascade in surgery opens, runs and closes NerveGuard. The remote reader sees the elements in the NerveGuard program change as they change on the machine in surgery.

NerveGuard Window NerveGuard Window Shown below is the main NerveGuard window. Refer to the individual sections of the help file for detailed information on operating NerveGuard and on each of the areas of the screen.

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Using the Graphical Site Selector The NerveGuard graphic site selector allows s to quickly and easily note the stimulated level, side and type of tool (if desired). Select a Level

At any time before threshold detection, click on the level and side of the spine graphic corresponding to the level being stimulated. If you have populated the site list in the NerveGuard setup dialog, the selections from your list will be available when you first click on the spine graphic. Double click on the spine graphic to by the site list. When NerveGuard finds the stimulus threshold, the system will display the threshold, time and site (if selected) in the tool tip text box.

No Level Selected – what happens?:

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Starting/Running Procedures If no side & level are selected on the Spine Graphic prior to threshold detection, the system will log the threshold as Not Specified. Editing a Threshold:

Instrument type, level and side can be assigned or reassigned after a threshold has been recorded. To edit a threshold entry, right click on a spinal level that has a threshold event assigned to it. Follow the submenu pop-out menus to select a tool, cut and paste the threshold to a new level or delete the threshold event all together. Cutting a threshold event will allow you to reassign that threshold event to a different side and level.

Repeating a Level:

To repeat a threshold detection session, simply reselect the appropriate area on the Spine Graphic. This area will be colored grey and a new threshold will be determined as soon as stimulus delivery is completed. The pedicle screw report will show all thresholds found for a selected level. All recorded thresholds for a level may be viewed in a mouse tool tip text box by placing the mouse over the level of interest. The tool tip will show the threshold intensity, time and tool type (if selected) for every threshold detection session.

Clearing a Level:

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Elite Operators Manual To erase or clear the threshold for a pedicle screw, right click over the appropriate area on the Spine Graphic, choose the appropriate threshold from the list if multiple thresholds were recorded and then select Delete. This should be done with the Control button set to the Standby mode. Selecting Spinal Levels above T12

A Zoom control is provided at the top of the graphic that allows viewing of the Full Spine or zoom-in of the Lumbosacral, Thoracic, or Cervical segments.

Control Button The main control button is always initiated in the Standby mode. Clicking on this large button switches the program to Detecting mode. In Detecting mode the program will automatically increase the stimulus intensity and determine threshold as soon as the stimulating device detects a complete electrical circuit such as when the stimulus probe makes with the pedicle screw or patient.

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If the maximum stimulus intensity is reached without obtaining a threshold value, the letters “NR” will be displayed to indicate No Response was detected.

Detection Mode This control determines how the NerveGuard program functions when a threshold is detected.

Screw Test - When stimulus threshold is detected the program stops stimulus delivery, and reports the stimulus intensity threshold. Continuous - When threshold is detected the program will continue to stimulate and will constantly report stimulus intensity levels. Fixed - To use the Fixed Detection Mode in NerveGuard, select the Fixed Detection Mode button in the upper right corner of the NerveGuard window, set the intensity slider to the desired intensity and click the Control Button to turn off standby. The intensity slider can be controlled by dragging the slider on screen using the mouse, using the up and down arrow keys on the computer keyboard and by rolling the scroll wheel on your mouse. The control button displays in real time the actual stimulus intensity being delivered. If no evoked EMG is detected, the background of the control button is gray. When an evoked EMG is detected, the control button displays the color corresponding to the stimulus intensity as set in the NerveGuard setup. If Threshold Tones are turned on, your computer will play the tone corresponding to the stimulus intensity delivered. Evoked EMG events detected in Fixed Detection Mode are logged and displayed in the pedicle screw stim report. Waveforms are stored only if the Store on Autocapture option is turned on in mode setup.

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EMG Trace Area During stimulus delivery this area displays triggered EMG traces. The most recent sweep is displayed (typically in white) as well as the last sweep to exceed the threshold criteria (typically in purple). When stimulation is not being delivered, this area displays free running EMG traces at a fixed sweep speed of 100 msec/division.

NOTE: Right click over the trace area to access functions such as Mode Setup (including the NerveGuard Setup Submenu) and Window Setup.

NerveGuard Setup Submenu Choosing the Nerve Guard submenu from the EMG Mode Setup window will display the following dialog.

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Intensity Criteria – determines the color displayed in the control box and sets the start and max stim levels. o o o

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Start - sets the stimulus intensity that NerveGuard starts at. Red-Yellow Boundary – sets the upper limit of the red threshold boundary and the lower limit of the yellow threshold boundary. Yellow-Green Boundary – sets the upper limit of the yellow threshold boundary and the lower limit of the green threshold boundary. Max - sets the maximum stimulus intensity the NerveGuard software will deliver and the stimulus intensity at which NerveGuard will report NR (no response).

Using the settings in the above example: Thresholds between 20-10 mA will be displayed in green. Thresholds between 9-5 mA will be displayed in yellow. Thresholds between 4-0 mA will be displayed in red. •

NerveGuard Rep Rate - Sets the repetition rate of stimulation in NerveGuard. NerveGuard always uses the repetition rate set here regardless of the setting in the EMG mode.

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Starting Zoom State – determines what image the Spine Graphic will display. Options are Lumbosacral, Full Spine, Thoracic and Cervical.

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Stimulus Intensity Increment – determines the increments (in milliamps, mA) that the program will use when it increases the stimulus intensity.

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Detection Mode – sets the program to run in “Screw Test”, “Continuous” or "Fixed" mode.

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Start and Max - sets the start and maximum intensities when running in Fixed stim mode. NOTE: Please refer to the NerveGuard Operation Section in the Starting/Running Procedures section for complete instructions on how to setup and operate NerveGuard.

Intensity Bar This region of the NerveGuard window indicates that the stimulus intensity if increasing and also shows the “High Z” impedance symbol. The “High Z” symbol is displayed when the circuit between the stimulating probe (cathode) and the return electrode (anode) is incomplete. When the circuit is completed, such as when the stimulus probe makes with the pedicle screw, the “High Z” symbol will be cleared and the program will automatically begin to increase the stimulus intensity. The red, yellow and green bars will ramp up as the intensity of the stimulator increases. When the stimulus probe is removed from the pedicle screw, the “High Z” symbol will return and the stimulus intensity is immediately returned to the starting value.

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Print Report Button Click this button to generate a summary report listing the levels stimulated and their corresponding threshold values. Use the report template called, “Pedicle Screw Stim Report”.

Below is an example of the report summary table.

NOTE: If no side & level are selected on the Spine Graphic prior to stimulation the summary report will include a row with a site name entry of “Not Specified”.

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Zoom Control Click the drop down arrow to view the Full Spine or zoom-in on the Lumbosacral, Thoracic, or Cervical segments.

Audio Controls This area contains four check boxes and an Audio intensity dial that determine what is heard during NerveGuard operation.

EMG Volume - Controls the volume of the Triggered Raw and Free Run Raw audio. The volume of the Threshold Tones and the Free Run Tones is controlled using the audio controls on your computer or external PC speaker. Threshold Tones - When enabled, a unique tone is played when the stimulus threshold level is detected. Triggered Raw - When enabled, the raw audio for the triggered EMG traces is heard during periods of stimulation. Free Run Tones - When enabled, the wav files assigned to the EMG channels will be played if the free-run EMG activity exceeds threshold during periods of free running EMG. Free Run Raw - When enabled, the raw audio for the EMG traces is heard during periods of free running EMG. NOTE: The Mute check box in the Mode Control Window on the main Cascade page mutes all audio regardless of the audio settings in the NerveGuard window. To use the audio functions in NerveGuard, be sure the Mute option is unchecked in the Mode Control window on the main Cascade page.

Closing NerveGuard To close the NerveGuard program, click on the red “X” in the upper right hand corner of the screen. If you close NerveGuard by accident, click on the NerveGuard icon again in the Cascade toolbar. The program will be redisplayed and all threshold values for completed screws will be recalled.

Operating the TCS

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Recording Transcranial Electric Motor Evoked Potentials The Mode Controls window on the main monitoring page contains stimulus controls for all of the modes created for the test you are running. Access the stimulus intensity knob, store button, clear button, train length setting, interstimulus interval setting, and polarity button by clicking in the mode box in the Mode Control window. The Single Trigger button (shown below) will trigger the TCSand is available without expanding the mode box. Be aware that TcEMEP stimulation may cause patient movement. Care should be taken to trigger the TCS only when there is no risk that patient movement could cause injury to the patient or surgical team.

TCS-1 800 Volts Max

TCS-100/TCS-4 1000 Volts

Max at 50 us PW To generate a TcEMEP, begin by setting the stimulus intensity to the desired level using the stimulus intensity knob, the Page Up and Page Down keys, or the up and down arrow keys on the computer keyboard. •

Click and hold the stimulus intensity knob while moving the mouse to rotate the intensity knob up and down. Single clicking on either half of the intensity knob will move the knob up or down in a stepwise manner in 2 Volt steps.

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Pressing the Page Up and Page Down Buttons on the computer will move the knob up or down in 20 Volt steps.

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Pressing the up or down arrow keys on the computer will increase or decrease the stimulus intensity in 2 volt steps. Use the Home button on the computer keyboard to return the stimulus to zero.

With the stimulus set at the desired intensity, trigger the TCS using the Single Trigger button in the Mode Control window for the appropriate mode. Again, be aware of the effect of patient movement as transcranial electric stimulation may cause the patient to jump. When the TCS is triggered, the voltage/current value will momentarily flash ‘yellow’ within the Mode Controls window and the Cascade software will display the resulting waveforms in the appropriate mode window replacing all active waveforms displayed at the time. Unstored data will be lost. Data may be auto stored or manually stored as described in Chapter 1. •

If you have selected the “Autostore” option in the procedure setup file, the computer will automatically store all waveforms at the time the waveforms are generated.

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If you have de-selected the “Autostore” option in the procedure setup file, the computer will display the triggered waveforms but will not automatically store the waveforms. To manually store the triggered waveforms, use the “Store” button in the Mode Controls window. To manually clear the triggered waveforms use the “Clear” button in the Mode Controls window.

The TcEMEP traces generated can be controlled (rescaled, moved, set as baselines, exported to reports, etc.) using the same controls as other evoked potential traces. Like other evoked potential modes, the MEP mode waveforms can be viewed in a summary window, waterfall window, cursor trend widow, 3D trend and analysis window. To add these windows to a view, choose the ‘View Setup’ option in the Edit menu.

Changing the Stimulus Parameters during a Recording During a recording, the stimulus polarity may be toggled by clicking the polarity ‘toggle button’ in the Mode Control window (Fig 3). The “normal” polarity setting delivers stimuli with the red output as anode (+) and the black output as cathode (-). The “reverse” polarity setting delivers stimulus with the red output as cathode (-) and the black output as anode (+). The stimulus intensity, train length, and interstimulus interval can also be changed here without having to go into the procedure setup file. In Cascade versions 2.2 and greater, the TCS-1000 is ed. In Cascade version 2.5, the TCS-4 is also ed. The TCS4 is capable of all of the changes herein described for the TCS-1000, with the added capability of changing the stimulation output channel. The pulse width on the TCS1000/TCS-4 can also be adjusted between 50us & 75us. With the TCS-1000/TCS-4 running Cascade version 2.2 or later you can also increase the stimulus intensity up to 1000V. Cascade will automatically sense the TCS-1/TCS-1000/TCS-4 hardware version to make the appropriate settings available.

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MEP Mode Controls TCS-1 Software Versions 1.3 & 1.4 1000 Software Versions 2.0

MEP Mode Controls TCS-

Polarity and stimulus parameters can also be adjusted in the Mode Setup dialog (Fig 4). Right click over the MEP trace window and then select Mode Setup from the context menu to access this dialog.

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The TCS-1 utilizes a fixed 50 microsecond, monophasic square wave stimulus pulse in hardware versions 1.3 and 1.4. This parameter can’t be changed in those hardware versions. TCS-1000 hardware version 2.0, running Cascade version 2.2 or later can adjust the stimulus pulse duration between 50us & 75us. TCS-1 stimulators hardware versions 1.3 & 1.4 would have to be sent back to Cadwell and be modified to a TCS-1000 hardware version 2.0 to use the increased stimulus parameters. You can check the hardware version of your TCS stimulator in the About Cascade window under the Help menu.

TCS-1 Hardware Version 1.3 and Software Version 1.03 only a single train and has a fixed stimulus pulse duration of 50us, with a train count of 9 and maximum intensity of 800 Volts.

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TCS-1 Hardware Version 1.4 and Software Version 1.04 double trains and has a fixed stimulus pulse duration of 50us, with a train count of 9, for one or two trains and maximum intensity of 800 Volts. The train count may be limited as the intensity is increased.

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TCS-1000 Hardware Version 2.0 and Software Version 2.0 s stimulus pulse durations of 50us & 75us and 1000 Volts maximum intensity for all 9 pulses train pulses. Combined dual train count ≤ 9.

Double-Train Facilitation for Transcranial Electrical Stimulation Double-train transcranial electrical stimulation has been shown to produce larger amplitude motor evoked potentials than single-train transcranial electrical stimulation when responses to single train stimulation are low amplitude (Journee HL et. al, Improved neuromonitoring during spinal surgery using double-train transcranial electrical stimulation, Medical and Biological Engineering and Computing, 2004 Jan, 42(1):110-3). The Cadwell Cascade is now capable of delivering double-train transcranial electrical stimulation using a single TCS-1 transcranial electrical stimulation unit and a single pair of stimulating electrodes. To use this feature, simply turn on the Double Train Stimulation feature in the Stimulator Setup window for the TCS-1 stim type. With Double Train Stimulation turned on, the Cascade will deliver two stimulus trains at the indicated stimulus settings. By default, the setting for train two are the same as the settings for train one. The system may be setup to deliver stimulus setting for train two different than settings for train one (see below). Inter-train interval is the time in milliseconds from the start of the first pulse of the first train to the start of the first pulse of the second train. The default ITI is 30msec. You may type or select an inter-train interval (ITI) as high as 250msec. The total train count across both trains must be ≤ 9 and the pulse train safety 158

Starting/Running Procedures cutoff limits of the current TCS-1/TCS-1000 apply (see Cascade Operator's Manual or Help file).

TCS-1 Hardware Version 1.4

TCS-1000 Hardware Version 2.0 The minimum ITI depends on the ISI of the first train and polarity of the second train. When the polarity of train one and train two are the same, the ITI must be at least as long as the duration of the first train. To calculate the minimum ITI when using the same polarity, simply multiply the number of pulses by the ISI. The system will alert you if

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To set stimulus parameters for the second train different than stimulus parameters of the first train, turn off the Use Train 1 Settings for Train 2 option.

TCS-1 Hardware Version 1.4

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TCS-1000 Hardware Version 2.0 When the polarity of the second train is different than the polarity of the first train, the ITI must be at least 5msec longer than the duration of the first train in order to allow the TCS-1 to switch polarity. To calculate the minimum ITI when using different polarities, simply add 0.5msec to the duration of train one. The system will alert you if the ITI is too short and will allow you to choose to have the ITI adjusted to the shortest allowable ITI.

If an invalid ITI is entered in the mode controls during run time, the system will deliver the last valid ITI and change the setting in the mode controls to the last valid ITI used. When Double Train Stimulation is turned on, the stimulus summary in the Mode Setup window shows the stimulus parameters for both polarities.

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A hardware and firmware the TCS-1 must be installed by Cadwell in order to use this feature. TCS-1 units without the upgrade will work with version 1.9.29 software and the Double-Train feature is disabled. The correct TCS-1 firmware for the upgraded TCS-1 is 1.04, TCS-1000 is 2.0 as seen in the About Cascade window accessed from the Help menu. TCS-1 units upgraded with the double-train hardware upgrade have a sticker on the back of the unit indicating the unit has been upgraded. TCS-1 units built with the Double-Train feature can be identified by the 02 rev in the serial number (ex: xxxxCXxx-02-xx). Please Cadwell service department at 800-245-3001 for pricing and scheduling to upgrade your TCS-1 stimulator. NOTE: Upgraded TCS-1 units can only be used with v1.9.29 or higher and will not work on Cascades running v1.8.11 or earlier.

Storing and Clearing Traces If the has selected the “Autostore” option in the procedure setup file, the computer will automatically store all waveforms at the time the waveforms are recorded and displayed. If the has deselected the “Autostore” option in the procedure setup file, the computer will display the triggered waveforms but will not automatically store the waveforms. The may manually store the triggered waveforms using the “Store” button in the Mode Controls window. The may manually clear the triggered waveforms using the “Clear” button in the Mode Controls window. The system will automatically clear the active waveforms when the device is triggered.

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Right click on MEP trace window and select Mode Setup Mode Tab in Procedure Setup file

Train Length Limit Warning

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Elite Operators Manual To improve the safety of cortical stimulation, the TCS-1 Hardware Versions 1.3 & 1.4 automatically limits the pulse train length delivered at high intensities. If the chooses a combination of voltage and train length that is outside established safety limits, the computer will display a warning icon (Fig 8) in the Mode Controls window.

If the Train Length Limit warning is displayed and the triggers the TCS-1, the TCS1 will deliver the voltage requested, but will limit the number of pulses to the predetermined safe values. A chart showing the relationship between pulse train length limits vs. voltage is shown below (Fig 9). The TCS-1000 does not have this limitation.

Chart of Pulse Train vs. Stimulus Intensity

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High-Z Warning In the event that the TCS-1 is triggered when the stimulating electrodes for the TCS-1 have a calculated impedance greater than 10,000 Ohms, the Cascade system will display a High-Z warning icon

in the Mode Control window.

Run Mode The MEP mode offers no Run-mode options. It will always be an Independent run mode type. The EP and EMG mode types offer the following Run-modes: Manual, Independent, Auto, Sync Start 1, Sync Start 2, Timer 1, Timer 2.

Artifact Reject Artifact Reject is available for all mode types using the TCS-1/TCS-1000/TCS-4. The reject setting is selectable from the Mode Setup dialog. It is recommended that the turn the artifact reject off when recording myogenic MEP responses.

Reject Setting Dialog The Artifact Reject Dialog allows for quick and easy adjustment of reject levels, allows reject to be turned off for individual channels, displays the frequency components of a selected channel and allows for turning on/off the Bovie Reject and Channel 16 reject features.

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Channel Reject Indicator: When one or more channels in a mode are setting off artifact reject, a Reject icon will appear next to the channel or channels that are setting off the artifact reject. The may adjust the reject levels or turn off Artifact Reject by accessing the Reject Settings dialog.

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There are four ways to access the Reject Settings dialog o o o o

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Click the Reject icon . Select the Reject Settings option from the right-click menu in the EP mode. Click the Setup Reject Info from the EP Global controls dialog located on the tool bar. Click the Setup Reject Info from the Procedure Setup dialog.

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When the Reject Settings dialog is accessed via the Reject icon, the dialog will default to highlighting the channel associated with the icon that was clicked to access the Reject Settings dialog. When the Reject Settings dialog is accessed in any other way, the dialog will default to highlighting the first channel in the list.

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The threshold data window displays reject level bars indicating the upper and lower limits of the threshold window. Live, free-running data for the

Starting/Running Procedures highlighted channel is displayed in the threshold data window if the mode is running. •

Adjust the artifact reject level to the desired setting by clicking on the squares on the reject level bars and dragging the bars to the desired position.

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Reject numeric artifact reject levels for each channel are listed in the fourth column of the channel list. The reject levels are displayed as percent of total gain and as micro Volts.

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To adjust the artifact reject limits for other channels in the mode, click on the channel name and adjust the reject level bars.

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To increment the reject limits for of all channels at the same time, click the up/down arrows on the All spinner control.

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To turn off artifact reject for one or more channels, deselect the check box for the appropriate channel in the Reject column of the channel list.

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The Noise Analysis sub-window at the bottom of the dialog displays the FFT analysis of the live data for the selected channel. This allows s to identify the dominant frequencies of the live data for the selected channel.

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Changes made in the Reject Settings dialog are applied immediately. The averager continues to run when exiting the Reject Settings dialog.

Enable Bovie Reject

Up to four electrocautery detection probes can be connected to detect the use of a Bovie device. Select this option so that data is not collected during periods of electrocautery use. Enable Channel 16 Reject

This channel can be used as a reject channel. Select this option to pause all data collection and mute the audio when the data on this channel exceeds the threshold. Reject On

Check the Reject option to eliminate excessive movement artifacts or other sources of noise from the running average. This reject is based on a pre-programmed percentage (usually 50%) of the amplifier’s full bandwidth setting. The total number of sweeps that are rejected is displayed in the Mode Control window as a percentage. This option automatically enables artifact rejection on all channels assigned to the mode. You can disable the feature for individual channels by entering the Reject Settings Dialog and removing the check mark next to the appropriate channel in the Reject column. When artifact rejection is completely disabled for all channels, every collected sweep is included in the running average. In the Mode Control window, the reject status is indicated as OFF.

Closing a Procedure

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Elite Operators Manual When you have completed testing, simply store unsaved data and choose the Close Procedure or Exit options from the File menu. You may now turn off your computer and Cascade base unit as normal. The TCS-1/TCS-1000/TCS-4 does not have its own power switch. Turning off the Cascade base unit turns off the TCS-1/TCS-1000/TCS-4.

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Reviewing a Procedure Reviewing a Procedure Use the arrows on the time bar to jump to events in the data file. Data is displayed for that time during the surgery. That is, you can move around in the file and review the trends, video, and trace data at any time during the surgery.

To review a procedure 1. From the File menu, select Review Procedure to display the Open dialog box. 2. Select the data file you want to view, and click Open to display the mode views. 3. You can review the data of any event during surgery. Changes made to the display properties of a procedure during review are saved to the patient file. When selecting a patient file located on a CD or other read-only media, the system will allow you to create a copy of the file on your computer in order to allow the display changes to be saved. By default, the copy of the patient file will be created in the Cascade data folder. The default name of the file will indicate that the file is a copy. Changes made to the patient file while reviewing are saved to the copy of the patient file and not to the patient file on the CD.

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Procedure Setup Procedure Setup - Overview Procedure Setup is the template editor for the settings used to perform testing. You must select an existing or create a new procedure setup file before you begin a monitoring session.

Components Procedure Setup consists of five sections: Channels, Modes (see Mode Overview), Views, Test Setup, and Other Setup.

To open new Procedure Setup file To open a blank Procedure Setup from the Start page:

Click New Procedure Setup. The Procedure Setup template editor will open. A text balloon will direct you to Channel Setup. See Channels to continue setup. To open a blank Procedure Setup from within a procedure

From the File menu, click Create New Procedure Setup File... The Procedure Setup template editor will open. A text balloon will direct you to Channel Setup. See Channels to continue setup.

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Elite Operators Manual To open an existing Procedure Setup from the Start page:

Click Start New Procedure OR click Edit Procedure Setup. See Step 1 below to continue. To open an existing Procedure Setup from within a procedure

From the File menu, click Edit Procedure Setup File. See Step 1 below to continue. To open the current Procedure Setup from within a procedure

To change the recording parameters of a test while running a procedure: From the Edit menu, click Current Procedure Setup or use the toolbar link shown below. Changes made will affect only the file you are currently recording, or you can save those changes as a permanent change to the settings file for future cases. See Step 1 below to continue.

1. An Open dialogue will appear. 2. A list of preformatted procedure setup files will appear. Choose one. The factory-installed procedure files include:

3. Double-click a procedure setup file in the list or select one and click Open. 4. The Procedure Setup template editor will open. A text balloon will direct you to Channel Setup. See Channels to modify setup.

Procedure Setup- Menu Options At the top left hand side of the Procedure Setup file is a pair of menu options: File and Test. The options include:

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NOTE: Changes made to a procedure setup file while the procedure is running will take place immediately.

At the bottom right hand side of the Procedure Setup file is a set of buttons: Print Procedure Setup, OK, and Cancel. These options include:

Print Procedure Setup

Generates a report that contains the procedure setup information. You may use the default template or click Select to browse for a different template. Click the Print button to open the report generator and print and save the report. Click the Edit button to open the report generator and make changes to the report, then you may print manually. Click the Cancel button to return to the Procedure Setup. OK

Click the OK button to save changes and close Procedure Setup. If you accessed Procedure Setup from the Start menu, you will return to the Start menu. If you accessed Procedure Setup from an open procedure, you will return to that procedure. Cancel

Click the Cancel button to close the window without saving any changes made to the file.

Procedure Setup - Channels The Channel Setup allows you to assign input labels to amplifier channels, adjust settings, set impedance references and exclude EMG channels from common mode.

To open Channel Setup To access Channel Setup from the Start page, open New Procedure Setup or Edit Procedure Setup. To access Channel Setup from within an open procedure, open the Edit menu and select Channel Setup, or use the toolbar link shown below. 173

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To begin creating or modifying a procedure setup, click the Channel Setup button.

Open or Save Input Settings Click the open folder button at the top left-hand side of the page to access existing input settings. Click the disk button to save the input settings to a new file.

Assign Input Settings 1. Edit Amplifier Inputs: The Channel Setup window will open. In pod A, doubleclick in the first text field, type in a text field or use the drop-down arrow to access a list of commonly used input labels. Assign input labels to amplifier channels as needed in pods A, B, C, and D.

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NOTE: Click the Default button on the bottom left-hand side of the screen to automatically assign input labels to all of the amplifier channels. Click the Clear All button to erase all input label entries from the amplifier channels. Click the Default button at the top of the Channels section to automatically assign input to amplifier channels. Click the Clear 1-16 button or the Clear 17-32 button to erase all channel fields.

2. Assign Inputs to Channels: Click the numbered buttons to the left of each input to which you will assign an acquisition mode. This will add the input to the Act and Ref fields of the Channels section on the right side of the screen. Select inputs until every channel you will be using is assigned. •

Act/ Ref: Each channel on the amplifier has an active (ACT) and reference (REF) connection. The active connection corresponds to the inverting (-) input and the reference connection to the non-inverting (+) input. When negative voltage is applied to the active input, or when positive voltage is applied to the reference input, an upward deflection is produced on the display. Use the active input for the recording electrode and the reference input for the reference or inactive electrode for a negative up convention. For a positive up convention, reverse the electrode connections.

3. Set the Filters: The Name, Gain, HiCut and LoCut fields are automatically generated. Change these fields according to the type of testing for which each channel will be used. Gain, filter, notch and audio settings can be set for an entire bank of channels using the All options at the bottom of the channel list. To delete a channel, right-click on a channel row and select Delete Channel.

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Name: A channel name is automatically generated based on the amplifier inputs you have entered for the channel (i.e. if an active input of a channel is T12 and the reference input is T10, the name will be T12-T10). Changes made in either the Test table or the Channel Settings section will be saved in both.

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Gain: The amplifier gain is the gain at which the amplifier hardware is set. EP modes use an amplifier gain of 10 or 20.

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HiCut, LoCut: Adjust the settings as needed according to the situation and type of signal you are measuring. Filters may be set independently in each channel. Values are in hertz (Hz). HiCut filter cuts off all frequencies above the filter setting. The LoCut filter cuts off all frequencies below the filter setting.

To adjust settings for channels 1-16, use the All section options in the middle of the Channels section. To adjust the settings for channels 17-32, use the All section options at the bottom of the Channels section.

4. Specify Notch Filter and Audio settings: Check the Notch box to reduce unwanted interference from power lines for that channel. Notch frequency is determined in the System Setup window and can be 60 or 50 Hz. Adjusting the Notch filters will reduce the overall capability of the program to run multiple modalities simultaneously, so do so sparingly. Applying a notch filter to an EP mode may induce ringing into the averaged signal. Check the Audio box to output the channel's signal to the computer speakers. This is most commonly used for EMG channels. The channels you create are displayed in the Channels area of the main Procedure Setup page.

5. Exclude EMG Channels from Common Mode: Click this option at the bottom of the channels section when the test includes EMG channels that should be excluded from the Common Mode rejection calculation of the amplifier. This improves the quality of the EP responses. MEP modes are always excluded from the Common Mode to improve signal quality. 176

Procedure Setup 6. Click OK.

Modes Mode Overview The mode setup is used to program stimulating and recording parameters for channels selected from the montage list. There are five types of modes used in this application EP, EMG, MEP, EEG, and TOF. Each mode type offers a set of options unique to the type of testing. For each mode, you can configure default settings for certain parameters (generally, those that require one-time or infrequent adjustment). You can also configure features that are unique to the different modes. Access Mode Setup and Window Setup from within a procedure:

Right-click a mode, and click Mode Setup or Window Setup. You can also open the Edit menu, select View Setup, highlight the window you want to edit and click the Window Setup button. Mode Setup allows you to adjust stimulus and cursor settings for that mode. Window Setup allows you to adjust view settings for that mode. You can also use the Global EP Window to make view changes to all EP modes at one time. Access Mode Setup from Procedure Setup:

1. Create the Acquisition Modes: Click the Add Mode button in the lower left corner of the Mode area. Name the mode and specify a type of mode from the drop-down list. Click OK. 2. Select Channels to be Monitored: In the Channels area on the far left side of the window, add inputs to the mode by clicking the enumerated buttons to the left of the channels in the list. This will add the channels to the Mode Channels. For EP and MEP mode types, the Channel Settings group has three columns of settings: The Amp Chn column lists the montage name from the montage list and amp channel number. The Name column lists the trace label name that will appear on screen during data acquisition. The Invert column allows you to invert the waveform on screen. The Side column, available only in EMG mode types, can be toggled left or right to determine in which side of the EMG window the trace will be displayed when the EMG window is split vertically or horizontally into two sections.

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3. Create Additional Modes: Click the Add Mode button. Repeat steps 5 and 6 above to create additional acquisition modes. Each new mode created has a tab folder assigned to it. Click the name on the tab to access the specified mode.

NOTE: You can save time in some of the steps by clicking Add Mode and selecting Copy Mode Setup and Copy Cursor Table. The program will copy these settings from the previously created mode. You may also select Copy Channels, Copy Channel Names and Copy Stim but you would then need to to change the first channel in the Channel Settings and change the stimulus from 1 to 2.

4. Define Mode Settings: •

EP - Evoked Potential. This mode type is used to record somatosensory, auditory, and visual evoked potentials. Motor evoked potentials can also be recorded using the EP mode type. It is recommended, however, that the MEP mode type be used for motor evoked potentials. See EP Mode Setup.

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EMG - Electromyography. This mode type is used to record free-run and stimulated or triggered-EMG. See EMG Mode Setup.

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MEP - Motor Evoked Potentials. This mode type is used to record motor evoked potentials from transcranial electrical stimulation. See MEP Mode Setup.

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EEG - Electroencephalography. This mode is used to record free-running EEG and quantified EEG such as CSA, DSA, Symmetry, Trending and Burst Suppression. See EEG Mode Setup.

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TOF - Train of Four. This mode is used to quantify the level of muscle relaxation at the target muscle when performing EMG. See Train of Four Mode Setup.

EP Mode Setup When you select a mode for EP, the Mode Settings options include:

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Acquisition Acquisition Sweep Acquisition sweep, or sweep speed, sets the time base in milliseconds per division (ms/div). This is the length of the epoch the system records with each sweep. The acquisition sweep may be set at a different speed than the Display Sweep. There are always 10 divisions across the display. Therefore: sweep speed x 10 = total timebase. Note: You can set sweep speed only at one of the preset values. If you enter a value not included in the list, the closest preset value is used. Sweep Delay determines the start of the sweep relative to the onset of the stimulus. A pre-stimulus sweep delay (negative value) is useful for acquiring pre-stimulus or baseline-level activity. A post-stimulus sweep delay (positive value) can be used to remove stimulus artifact from the display. The value can be set to -1.0, 0.0, or 1.0 division. Sweep duration is always 10 divisions long. Average Count A counter that shows the number of sweeps collected during waveform averaging. Autostore on Avg Complete Check this option to have the Cascade automatically store the traces when the average count is reached. This option is ignored for Modes that have the Run Mode set to ‘Manual’. AutoPlace Cursors on % of Avg Complete When this setting is enabled the program will automatically place cursors on the active traces when the specified percentage of the total average count is reached. These cursors will be saved to the stored waveform when the active trace is saved. Autocursors on Percent of Average in the EP mode setup can be toggled off entirely. When Autocursors are turned off, the system will not place cursors on the live waveform when running in auto or manual run mode. When 179

Elite Operators Manual Autocursors are turned on the system will place cursors on the stored waveforms. When Autocursors are turned off, the system will not place cursors on stored waveforms with in manual run mode. Run Mode: This setting defines how a mode reacts to the Run All, Store All and Clear All buttons. The option is available for each mode setup tab within the Procedure Setup screen, and also in the Mode Control window. The option affects how the mode behaves when the "All" buttons are pressed. The following selections are available. Manual: The Run All, Store All and Clear All buttons at the top of the Mode Controls window do not affect the mode. This mode will respond to the All Manual Mode controls, and is usually used from EMG. Auto: The system automatically stores and places auto cursors when the Average Count is reached for this mode. When the average count is reached, the trial is stored, cursors are placed on it, and the averager is cleared and restarted. If this selection is applied to an EMG mode, it simply means that the mode will be affected by the Run All and Store All buttons. The Clear All button will never affect an EMG mode. SyncStart1/SyncStart2: When a mode has SyncStart1 specified, averaging is not restarted until all other modes with SyncStart1 selected have reached their average count. As each mode reaches its average count, the trial is stored, cursors are placed, and the averager is cleared. SyncStart2 behaves the same way, but provides a means for having two different groups of modes. These selections are not available for EMG modes. Timer1/Timer2: Two timers allow modes to start on a specified interval. The interval can be set in the main setup dialog or from the mode control view. These timer values are stored in the setup file. For example, if Timer1 interval is set to 60 seconds, and the Run All button is clicked, the modes run until their average count is reached. The trial is stored, cursors placed, and the averager cleared. When 60 seconds has elapsed from when the last mode in the group has completed, the modes start again. If the Run All button is turned off, the timers are paused. A Clear Timer function is available in the Mode Control View. These selections are not available for EMG modes. Independent: Modes with this setting do not respond to the All Mode Controls or the All Manual Mode Controls. This is a good choice for MEP modes. Digital Filter See Digital Filters for more information. EMG Remove Stim Artifact from EMG For stimulated EMG modes, select this option to remove the stimulus artifact from the display and audio output. When this is selected for an EP mode, which is using an electrical stimulator (i.e., Rt Median SEP), it will enable the stimulus artifact to be removed from EMG traces. The system zeros the data during stimulus delivery and for a -selectable time period between 0.5 to 5.0 milliseconds after the stimulus. Stimulator

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Procedure Setup Stim Type Click the drop-down arrow and select or . Default parameters will appear in the box above. To change these parameters, click on the Setup Stim button. Choose a Repetition Rate (Rep Rate), then select the Stim Channel (either 1 - 16 for high current, or Low 1 for low current). The Stim Channel number corresponds to the numbered outputs on the electrical stimulus splitter box. Click OK. Note: The ES-IX only works on the Cascade Elite and PRO. Note: The Cascade PRO can use only the ES-IX stimulator, and not any of the electrical stim splitters. Note: The Paired Stimuli stim type only works on the Cascade Elite and PRO. Modes configured with Paired Stimuli stim type will be disabled. The mode will be enabled when the stim type is changed. Note: The high-frequency train used with any of the constant-current Estims only works on the Cascade Elite. Modes configured with high-frequency train used with any of the constantcurrent Estims will be disabled. The mode will be enabled when the train stim is disabled. The TCS tceMEP stimulators will work on the Cascade, Cascade Elite, and Cascade PRO. Setup Stim Click to set up stimulator specifications, such as rep rate, label name, stimulator number, pulse width, and maximum intensity. Note: Select Stim Type TCS-1 to assign a TCS to a mode. Open Stim Setup and edit stimulus parameters. The starting polarity (normal or reverse) can be programmed for each mode in the procedure setup file. The default polarity is normal. Setup See Setting Setting Up Trace Labels, Setting Up Cursor Tables and Setup Reject Info for more information.

EMG Mode Setup The EMG Mode Setup window has four submenu options: General, Stimulator, Trace Labels, NerveGuard, and EMG Comments. Select the submenu to work with by choosing the submenu from the Setup list in the upper right corner of the EMG Mode Setup window. When the Mode Setup window is opened from the right-click menu during data acquisition, the window includes sweep, and gain options. When switching between these submenus, the display settings on the left side of the window remain the same. When accessing the Mode Setup area in the procedure setup file, the sweep and gain controls can be found in the Window Setup for the EMG window.

General Setup

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Sweep Specifies sweep length of the traces. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase Sweep Delay Sweep delay determines the start of the sweep relative to the onset of the stimulus. A pre-stimulus sweep delay (negative value) is useful for acquiring prestimulus or baseline-level activity. A post-stimulus sweep delay (positive value) can be used to remove stimulus artifact from the display. The value can be set to -1.0, 0.0, or 1.0 division. Use Display Gains allows channels used for both MEP and EMG recordings to be set at an MEP gain in the channel setup window for MEPs and then set a display gain in the EMG window to display data correctly in the EMG and TEMG windows. Channel 16 Mute Audio Mutes the audio, prevents auto-storing, and pauses stimulation when Channel 16 reject is triggered. Bovie Mute Audio Mutes the audio, prevents auto-storing, and pauses stimulation when Bovie reject is triggered. Wave/Beep on Threshold plays a selected *.WAV file when that EMG recording channel crosses the set threshold. Autocapture on Threshold captures and displays the trials where one or more EMG channels crosses threshold. Store on Autocapture stores EMG waves that are Autocaptured on Threshold. Store Timelock Stim stores TEMG up to 5 Hz. Timelock Stim must be selected in the TEMG mode controls box in the acquisition screen. While the Store Timelock Stim is running SEP,TOF and EEG modes will be paused. EMG data is stored continuously

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Procedure Setup while the mode is running. The faster the hard drive can spin the better it will perform. Autocapture on Threshold and Store on Autocapture are automatically disabled when Store Timelock Stim is selected. Selecting Autocapture on Threshold or Store on Autocapture will automatically disable Store Timelock Stim. The more data that is captured the more the process of writing to the computer hard drive taxes the system. It is recommended that you use a computer hard drive that spins at 7200 rpm or faster to effectively use this feature. Setup Thresholds You can set a threshold level, in microvolts, for each channel in the EMG mode only. See Setup Thresholds for more information. Run Mode sets the run mode type. Manual Mode is linked to the All Manual modes control box in the Mode Controls box in the acquisition screen. Auto Mode is linked to the All Auto modes control box in the Mode Controls box in the acquisition screen. Independent runs the mode independently from the All Auto and All Manual global mode control box. •

Manual run mode responds to the to the All Manual Modes run/stop controls.

•

Independent run mode does NOT respond to the to the All Manual Modes or All Auto Modes run/stop controls.

•

Auto run mode responds to the to the All Auto Modes run/stop controls.

Stimulator Setup

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Play Sound on Stim Plays a selected sound file when the stimulus probe makes . Suppress Audio During Stim Select this option to suppress the sound of the stimulus artifact from the audio while that mode is running. Remove Stim Artifacts Select this option to remove electrical stimulus artifacts from the EMG traces. Not only will stimulus artifact related to the EMG mode’s stimulator be removed but it will also remove stimulus artifact coming from EP modes that have "Remove Stim Artifact from EMG" enabled in their mode setup options. Stim Mode Select this option to start the mode in stim mode "Hold", "Repetitive" or "None". See the EMG Stim Controls section for a description of the stim modes. Stim Type The Cascade ElitePRO uses electrical, ES-IX, audio, visual, TCS, and CV-2 stimulators. Select a stimulator type from the drop-down list. Click the Setup Stim button for various options to set up each stimulator type. To trigger an external device, select External Trigger. A special external trigger interface box is required for this implementation. NOTE: The Paired Stimuli stim type only works on the Cascade Elite and PRO. Modes configured with Paired Stimuli stim type will be disabled. The mode will be enabled when the stim type is changed. NOTE: The high-frequency train used with any of the constant-current Estims only works on the Cascade Elite. Modes configured with high-frequency train used with any of the constantcurrent Estims will be disabled. The mode will be enabled when the train stim is disabled. The TCS tceMEP stimulators will work on the Cascade, Cascade Elite, and Cascade PRO.

Setup Stim Click to set up stimulator specifications, such as rep rate, label name, stimulator number, pulse width, and maximum intensity. NOTE: To monitor Live EMG or EEG, create a mode in the same manner but do not assign a stimulator to the mode. For Stimulated or Triggered EMG, you must assign an electrical stimulator to the mode. NOTE: Select Stim Type TCS-1 to assign a TCS to a mode. Open Stim Setup and edit stimulus parameters. The starting polarity (normal or reverse) can be programmed for each mode in the procedure setup file. The default polarity is normal.

Trace Labels Setup See Setting Up Trace Labels.

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NerveGuard Setup See NerveGuard Procedure Setup.

EMG Comments Setup

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Use this submenu to create a preset list for SIDE, LEVEL, and SITE. These fields are displayed in the EMG Mode Control area. When an EMG sweep is stored these comments are automatically tagged with the traces. One example of where these comments could be useful is during Pedicle Screw stimulation. You can also type new entries in any of these fields in the Mode Controls area after the procedure has started.

EMG Stim Controls The mode control dialog for EMG modes with a stimulator assigned will have the following controls: Single button, Repetitive check box, Hold check box, and Train button. An EMG mode may be preconfigured in the Mode Setup to start with the Repetitive or Hold check boxes checked. Selecting the stim mode as none will effectively start the EMG mode in free-run mode with no stimulus being delivered. The following table describes the behavior of the Run and Single buttons based on the running state and the state of the two check boxes:

MEP Mode Setup 186

Procedure Setup When you select a mode for MEP, the Mode Setting options include:

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Acquisition Acquisition Sweep Acquisition sweep, or sweep speed, sets the time base in milliseconds per division (ms/div). This is the length of the epoch the system records with each sweep. The acquisition sweep may be set at a different speed than the Display Sweep. There are always 10 divisions across the display. Therefore: sweep speed x 10 = total timebase. NOTE: You can set sweep speed only at one of the preset values. If you enter a value not included in the list, the closest preset value is used.

Sweep Delay Sweep delay determines the start of the sweep relative to the onset of the stimulus. A pre-stimulus sweep delay (negative value) is useful for acquiring pre-stimulus or baseline-level activity. A post-stimulus sweep delay (positive value) can be used to remove stimulus artifact from the display. The value can be set to -1.0, 0.0, or 1.0 division. Sweep duration is always 10 divisions long. Autostore Check this option to have the Cascade automatically store the traces after the stimulus train is delivered. Digital Filter This digital smoothing filter is used to improve the quality of the evoked potential waveform by applying a digital filter to the averaged waveform. For more information, please see Digital Filters.

EMG Remove Stim Artifact from EMG For stimulated EMG modes, select this option to remove the stimulus artifact from the display and audio output. When this is selected for an EP mode, which is using an electrical stimulator (i.e., Rt Median SEP), it will enable the stimulus artifact to be removed from EMG traces. The system zeros the data during stimulus delivery and for a -selectable time period between 0.5 to 5.0 milliseconds after the stimulus.

Stimulator Stim Type Click the drop-down arrow and select a stimulus type. Stimulus types available in the MEP mode include TCS-1 (which includes the TCS-1000 and TCS-4), CV-2, External Trigger, Electrical, Visual and Paired Stimuli. Default parameters will appear in the box above. To change these parameters, click on the Setup Stim button. NOTE: The Paired Stimuli stim type only works on the Cascade Elite. Modes configured with Paired Stimuli stim type will be disabled. The mode will be enabled when the stim type is changed. NOTE: The high-frequency train used with any of the constant-current Estims only works on the Cascade Elite. Modes configured with high-frequency train used with any of the constant-current Estims will be disabled. The mode will be enabled when the train stim is disabled. The TCS-1/TCS-1000/TCS-4 tceMEP stimulator will work on the Cascade and Cascade Elite.

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Elite Operators Manual Setup Stim Click to set up stimulator specifications, such as rep rate, label name, stimulator number, pulse width, and maximum intensity. For the stimulus type Electrical, check the Train box to deliver a train stimulus. NOTE: Select Stim Type TCS-1 to assign a TCS to a mode. Open Stim Setup and edit stimulus parameters. The starting polarity (normal or reverse) can be programmed for each mode in the procedure setup file. The default polarity is normal.

Output Channel The output channel for a TCS-4 can be specified within the Setup Stim menu or from the Mode Controls window. In the Mode Controls window, the selected output channel is written in parentheses.

Setup See Setting Up Trace Labels, Setting Up Cursor Tables and Setup Reject Info for more information. NOTE: There is no Run Mode setting for MEP Modes. These types of modes do not respond to the All Mode controls or to the All Manual Mode controls, they only respond to their individual controls (i.e. the Single Trigger button).

MEP mode controls in Procedure Setup File Right Click on MEP trace Window>Mode Setup

Train of Four Mode Setup When adding or updating a TOF mode, the following options are available:

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Auto Store on Train Complete: When this box is enabled the program will auto-store the run after delivery of the fourth stimulus. At this time the auto-cursors will be placed on the stored run. Remove Stim Artifact from EMG: When this box is enabled the stimulus artifact from the TOF stimulator will be removed from the live EMG traces. The system zeros the data during stimulus delivery and for a -selectable time period between 0.5 to 5.0 milliseconds after the stimulus. The Remove Stim Artifact option must also be checked in the EMG mode. Run Mode This setting defines how a mode reacts to the Run All, Store All and Clear All buttons in the Mode Controls while running a procedure. The option is within the Procedure Setup screen, and in the Mode Control window. The following selections are available: •

Manual: The Run All, Store All and Clear All buttons in the All Auto box of the Mode Controls window do not affect the mode. This mode will respond to the All Manual Mode controls.

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Independent: Modes with this setting do not respond to the All Mode Controls or the All Manual Mode Controls. This is a good choice for MEP modes.

•

Timer1/Timer2: Two timers allow modes to start on a specified interval. The interval can be set in the main setup dialog or from the mode control view. These timer values are stored in the setup file. For example, if Timer1 interval is set to 60 seconds, and the Run All button is clicked, the modes run until their average count is reached. The trial is stored, cursors placed, and the averager cleared. When 60 seconds has elapsed from when the last mode in the group has completed, the modes start again. If the Run All button is turned off, the timers are paused. A Clear Timer function is available in the Mode Control View. These selections are not available for EMG modes.

Stim Type Click the drop-down arrow and select Electrical or ES-IX. Default parameters will appear in the box above. To change these parameters, click on the Setup Stim button. 191

Elite Operators Manual Setup Stim Click to set up stimulator specifications, such as rep rate, label name, stimulator number, pulse width, and maximum intensity. Choose a Repetition Rate (Rep Rate), then select the Stim Number (either 1 - 4 for high current, or Low 1 for low current). The Stim Number corresponds to the numbered outputs on the electrical stimulus splitter box. For best results, stimulate the patient's posterior tibial nerve at the ankle or median nerve at the wrist. This stimulating electrode pair can be the same pair being used in one of the EP modes. When stimulating the posterior tibial nerve, record from an active electrode in the adductor hallucis referenced to a quiet, non-muscular reference on the foot. When stimulating the median nerve, record from an active electrode in the abductor pollicus brevis referenced to a quiet, non-muscular reference on the hand. The surface of the skin should be well prepped and dried before placing surface electrode for recording or stimulating.

Mode Setup Digital Filters The digital smoothing filter is used to improve the quality of the evoked potential waveform by applying a digital filter to the averaged waveform. Seven digital smoothing filters can be enabled for evoked potential acquisition modes. The filters are named SF1, SF2, SF3, SF4, SF5, ABR1, and ABR2. The SF1 filter provides the least amount of filtering, the SF5 provides the most. The ABR1 and ABR2 filters are designed for use with short latency auditory evoked potentials. Digital Filters can be preprogrammed on a per mode basis in the Edit Procedure Setup window or they can be selected after the procedure has been started by right clicking on the appropriate EP Average window and selecting Mode Setup. When enabled, these filters will automatically smooth the active trace as well as every stored trace that has been acquired for the selected mode. The filters are completely reversible and can be disabled at any time by selecting NONE as the filter selection. SF Filters The SF smoothing filters are reversible FIR filters that have a very steep roll-off. The –6db point of the filters will change according to the sweep speed. The table below shows the –6db point frequency (the frequency at which the amplitude is reduced by 50%, indicated as 0.5 on the graph) for each filter at four different sweep speed settings.

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1.0 ms/div

2.0 ms/div

5.0 ms/div

10.0 ms/div

SF1

4000

2000

800

400

SF2

3000

1500

600

300

SF3

2000

1000

400

200

Procedure Setup SF4

1500

750

300

150

SF5

1000

500

200

100

ABR Filters The ABR1 and ABR2 filters work differently. At sweep speeds of 1.0 ms/div., the ABR1 filter boosts frequencies around 1000 Hz and then rolls off steeply on either side of this. This filter is supposed to enhance all five peaks of the ABR response: it will reduce amplitude slightly and does not affect the peak latencies. The ABR2 filter boosts frequencies around 750 Hz and rolls off steeply to either side. This filter is supposed to enhance waves I, III, and V only. The ABR2 filter will reduce the amplitude of the response by 20-30% and will cause latencies to shift in an earlier direction by .1-.3 ms. When the sweep speed is changed from 1.0 to 1.5 ms/div the frequencies that these filters are boosting shift to slightly slower frequencies, around 750 Hz for the ABR1 filter and 500 Hz for the ABR2 filter.

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Setup Reject Info The Artifact Reject Dialog allows for quick and easy adjustment of reject levels for EP recording channels. It allows the reject to be turned off for individual channels, displays the frequency components of a selected channel and allows for turning on/off the Bovie Reject and Channel 16 reject features, as well (see Electro-Surgery Detector and ElectroSurgery Reject). Reject On

Within a procedure, right-click in a mode and select Reject On to eliminate excessive movement artifacts or other sources of noise from the running EP average. This reject is based on a pre-programmed percentage (usually 50%) of the amplifier’s full bandwidth setting. The total number of sweeps that are rejected is displayed in the Mode Control window as a percentage.

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This option automatically enables artifact rejection on all EP channels assigned to the mode. You can disable the feature for individual channels by entering the Reject Settings Dialog and removing the check mark next to the appropriate channel in the Reject column. When artifact rejection is completely disabled for all channels, every collected sweep is included in the running average. In the Mode Control window, the reject status is indicated as OFF. NOTE: If you are going to perform myogenic TcEMEPs (recording from muscles) it is recommended that you leave the Reject Info option in its default Off position for the TCEMEP modes.

Reject Settings

When one or more channels in a mode are setting off the artifact reject, a Reject icon will appear next to the channel or channels that are setting off the artifact reject. The may adjust the reject levels or turn off Artifact Reject by accessing the Reject Settings dialog. There are four ways to access the Reject Settings dialog •

Click the Reject icon in the waveform display.

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Select the Reject Settings option from the right-click menu in the EP mode.

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Click the Setup Reject Info from the EP Global controls dialog located on the tool bar.

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Click the Setup Reject Info from the Procedure Setup dialog.

When the Reject Settings dialog is accessed via the Reject icon, the dialog will default to highlighting the channel associated with the icon that was clicked to access the Reject Settings dialog. When the Reject Settings dialog is accessed in any other way, the dialog will default to highlighting the first channel in the list. The threshold data window on the left displays reject level bars indicating the upper and lower limits of the threshold window. Live, free-running data for the highlighted channel is displayed in the threshold data window if the mode is running. Adjust the artifact reject level to the desired setting by clicking on the squares on the horizontal reject level bars and dragging the bars up or down to the desired level. 195

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The reject numeric artifact reject levels for each channel are listed in the fourth column of the channel list on the right. The reject levels are displayed as percent of total gain and as micro Volts for each channel. To adjust the artifact reject limits for other channels in the mode, click on the channel name and adjust the reject level bars for that channel. To turn off artifact reject for one or more channels, deselect the check box for the appropriate channel in the Reject column of the channel list.

To increment the reject limits for of all channels at the same time, click the up/down arrows on the All spinner control.

The Noise Analysis sub-window at the bottom of the dialog displays the FFT analysis of the live data for the selected channel. This allows s to identify the dominant frequencies of the live data for the selected channel by moving the EFT marker over the dominant peak on the trace being displayed.

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Changes made in the Reject Settings dialog are applied immediately. The averager continues to run when exiting the Reject Settings dialog.

Setting Up Cursor Tables The EP modes use auto cursors to mark important waveform features. The measurements that the cursors represent are used to calculate latency, inter-latency, and amplitude values. For each, you can configure the following: •

Names of the cursors and the mode channels they are associated with.

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Specific feature for which each cursor searches (peak or trough).

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Start and end latency or midpoint and range search times.

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Which cursors you want to use to calculate latency, interpeak latency, amplitude, and interamplitude measurements.

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Trace Mode or Trial Mode cursors.

Features

The features available to trend are defined in the Cursor Table for each EP mode. They are the Latencies, Amplitudes and Inter-Latencies defined from the cursors that are selected for that EP mode. Click the drop down arrow to select the desired feature to trend. Up to four features can be trended for each Cursor Trend Window. If there are additional features that need to be trended for an EP mode, a copy of the Cursor Trend Window will be required. Channels

The recording channel can be selected or changed in the EP Cursor Trend Window setup only if the Trial Mode Cursors box is not selected in the cursor table for the EP mode. To configure auto cursors

Setup Cursor Table can be accessed from the Mode Settings section of a Procedure Setup file. 1. Click the Setup Cursor Table button to display the Cursor Table window

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2. Complete the Cursor Table Fields. The table below describes each field and how to use each field. Name

Feature

Up to 15 names of cursors. A cursor must be given a name to be positioned on a waveform. All cursor names must be unique. You may use capitalization to create uniqueness between cursors with the same name. Waveform feature you want each cursor to search for: Peak—To locate the highest point within the start and end latency time period (a negative value). Trough—To locate the lowest point within the start and end latency time period (a positive value). Onset—To locate the beginning of a trace on its way up to the peak.

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Start Lat. / End Lat.

Specify the start and end latency, in milliseconds. These determine the time range in which the cursor may be placed to identify the actual feature.

Mid Point /

Specify the expected midpoint (mean) value for the cursor and a

Procedure Setup Range

range (+/-) to either side of this value in which the cursor may be placed to identify the actual feature.

Mode channel When specified, the cursor is placed only on traces acquired # associated from that channel. Enter as many channels as needed. with the cursor Amplitude

Up to 10 sets of cursors that you want to use for calculating voltage difference. You can also enter a normal (Norm) value for the measurement.

InterAmplitude Type of calculation for interamplitude: Diff—To show the difference between two amplitudes, calculated by subtracting the second Amplitude cursor from the first. Ratio—To show the ratio of two amplitudes, calculated by dividing the first Amplitude cursor by the second cursor. You can also enter a normal (Norm) value for the measurement. Latency

Up to 15 cursors that you want to use for latency calculations. For each cursor, you can enter a normal value for the measurement.

InterLatency

Up to six sets of cursors that you want to use for interpeak latency calculations. For each pair, you can enter a normal value for the measurement.

Trial Mode Cursor

Group of traces where you can specify on which channels each cursor will be placed. When the Trial Mode Cursor check box is un-checked, Trace Mode cursors will be used. With trace cursors, all cursors are on a single trace; you are not able to select channels for the cursors.

o

click the Default button to select from a list of available tables.

o

click the Clear button to clear all fields and enter new data.

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click the Store button to save data to a file.

o

click the Retrieve button to open an existing cursor file and use that data for the current procedure setup file.

3. Click OK to save your changes. See also:

Working with Cursors EP Cursor Trend Window Setup

Setting Up Trace Labels The trace label consists of up to three fields, separated by either a dash, colon, space, or carriage return. Click the drop-down arrow for a field and select from the following list: 199

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None - no label appears in the field.

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Trial# - displays the trial number on stored runs.

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Ch. Name - displays the channel name.

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Gain - displays the amplifier gain (for EMG channels) or the display gain (for EP channels).

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Intensity - displays the stimulus intensity.

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Time - displays the time of day.

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Amplitude - displays the peak-to-peak amplitude of the trace, this label is only available for EMG modes and only for triggered, manually stored, autocaptured, or auto-stored traces.

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Peak Lat. - displays the peak latency of the trace, this label is only available for EMG modes and only for triggered, manually stored, auto-captured, or autostored traces.

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Stim Params - displays all the stimulus settings for the mode; intensity, repetition rate, pulse width, etc.

For EP and MEP modes:

For EMG modes:

The top row is used to set the trace labels for the Live EMG traces. The second row is used to set the trace labels for Auto-Captured, Auto-Stored, and Manually Stored EMG traces. NOTE: The Amplitude and Peak Latency labels will produce some slowing of the EMG trace update rate during triggered-EMG. The slowing increases as more channels are added to the mode. If you are planning to stimulate at a high repetition rate (> 5 Hz) then you may want to turn off these trace labels.

Setup Thresholds 200

Procedure Setup You can set a threshold level, in microvolts, for each channel in the EMG mode. When the threshold is exceeded the PC will play the sound file that has been assigned to that channel. Several default sound files are installed for you to choose from. The sounds are played through the laptop or desktop PC’s speakers, not through the speaker in the Cascade base unit. To adjust the volume of the sound, use the volume control on the laptop or desktop PC.

Wave / Beep

Checking this box causes the Cascade to play the assigned sound file when a channel exceeds its threshold setting. , the sounds are played through the laptop or PC’s speakers, not through the Cascade base unit. To adjust the volume of the sounds, change the laptop or PC’s sound volume. NOTE: In order to keep the system from beeping due to stimulus artifacts you will need to enable the "Remove Stim Artifact From EMG" feature.

Autocapture on Threshold

Checking this box causes the Cascade to hold the EMG sweep on the screen until a new threshold crossing occurs. The held sweep is colored "purple" on the screen and is positioned slightly above the Live EMG traces. The triggering sweep is offset by 3 divisions so that any threshold activity which occurs at the end of the sweep can be seen in its entirety.

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Elite Operators Manual When performing stimulated EMG using the HOLD mode, the auto-captured traces are not offset by three divisions. Store on Autocapture

Checking this box causes the Cascade to automatically store each EMG sweep that crosses the threshold. Sweeps can be stored at a rate of one sweep every 3 seconds. The EMG Comment dialog is disabled for auto-stored EMG. Setup EMG Threshold options: •

Threshold (uV) – sets the threshold voltage level, in microvolts. The threshold value is measured from baseline to peak, not peak to peak.

•

Phase – can be set to trigger on the Upward, Downward or Both phases of the response.

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Clear – clears the assigned sound file.

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Sound – shows the path to the selected sound file.

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Select button – click here to assign a sound file to the channel. Default sounds are located in the C:\Cadwell\Cascade\Wavs folder.

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Test button – click to play the sound you have selected. NOTE: You can record your own sound files using WAV recording software. The sounds need to be relatively short so that the system can play them rapidly during threshold crossing.

Mode Window Descriptions Mode Windows Setup Overview Each mode window in the View list can be customized using the Mode Window Setup dialog. You may access this dialog three ways. When in Procedure Setup, highlight the window you would like to edit and click the Windows Setup button. While running a procedure, right click on the window you would like to edit and choose the Window Setup option. While running a procedure, choose View Setup from the Edit menu, highlight the window you would like to edit and click the Windows Setup button.

Mode Controls The Mode Controls window turns the data acquisition on and off, stores data, and provides other options. The Mode Controls Window controls which mode run and when. The mode controls window allows you to run the modes individually or all concurrently, except for MEP modes. You may also group modes to allow you to control groups of mode together. By default, the Mode Control window is available in every view. You may remove the Mode Controls window from a view using the View Setup options. The Mode Controls window provides controls for each of the acquisition modes. The controls allow you to run the acquisition modes at different intervals or concurrently. If the Cascade cannot deliver the requested repetition rate for a mode, the Repetition Rate warning symbol will be displayed. The actual repetition rate that the system is 202

Procedure Setup delivering to the patient is displayed next to the warning symbol. In order to remove the RR warning, you may need to adjust the repetition rates or sweep speeds of other acquisition modes.

EP Average Window The Average window displays Averaged, Live, and Stored traces from an EP mode. It allows you to display 0 to 10 stored trials in a trend fashion. You can also place and move cursors on traces and display time and amplitude markers. The Average window also allows you to set baseline trials. TIP: You can change the trace gains by selecting a trace and spinning the mouse wheel.

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Run Starts and stops acquisition for the mode. Single Fires the assigned stimulator once. Store Stores the current average. Clear Clears the current average. Reject When artifact reject is enabled, the reject percentage value is displayed in the window. If the amplifier gain setting is 10 uV/division this means that the Live trace has an amplitude window of 100 microvolts (10 vertical divisions times 10 uV/div.) with 50 uV above baseline and 50 uV below baseline. If the reject level is set to 50%, then the amplitude of the Live trace can’t exceed +/- 25 uV or it will be rejected from the running 206

Procedure Setup average. The lower the reject level setting the more sensitive the program will be in rejecting large artifacts. Mode Setup Please see Mode Setup Overview Add Time Marker Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Set Baseline Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Auto Place Cursors If no traces are selected (yellow) then cursors are automatically placed on the live traces (white). Otherwise they are placed on the selected trace. Show Cursors Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information. Clear Cursors Clears the cursors from the selected trial/trace. Adjust Latency Available after a trial has been selected. Takes the values for the current positions of the auto-cursors on the selected trial and resets the auto-cursor Start Latency to -90% and the End Latency to +110% of these values. Grand Average Allows stored trials to be averaged together. This function is only available when more than one stored trial has been selected in the window. The resulting grand average traces, for each channel, are displayed in 'green' color and the trace label will contain the letters 'GA'. Live When checked, the live, unaveraged traces are displayed. When unchecked, the averaged traces are displayed. Note that this does not affect the display of the stored traces.

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Elite Operators Manual Trial Select On When this option is checked, clicking on a trace selects or clears all the traces for a trial. When unchecked, traces are selected individually. Smooth Select Smooth to smooth selected traces in EP Windows. Unsmooth Select Unsmooth to reverse smoothing selected traces in EP Windows. Delete Trials Selected trials will no longer be displayed in the Average view. Restore Deleted Trials Restores all deleted trials. Auto Position (On-Off) When this feature is turned OFF moving the active "white" traces will not automatically re-position the stored or baseline traces, nor will exiting from the Average window’s Setup dialog. The default setting is auto-position turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Select All This function selects are trials that are currently displayed within the window. Deselect Traces Returns all selected traces, displayed in "yellow", to their original color. As Recorded Gain When this feature is turned ON the appropriate display gain will be shown for the Average window as you move back through the recording timeline. When this feature is turned OFF, the display gain will not change but will remain at its current setting when moving back through the timeline. The default setting is As Recorded Gain turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Reset Trial Positions Will reset the trial positions of the data back to a default position on the screen. Window Setup Please see EP Average Window setup Global EP Setup This displays the Global EP Settings window, as shown below. You can change most of the EP window display settings, either for all EP modes or selected EP modes, from this one window.

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Copy Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Copy Cursor Table Copies a text version of the cursor table information to the Windows clipboard. The information can be pasted into a word processor or spreadsheet. The table includes cursor values for each of the stored trials, displayed in the Average window. Print Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output Traces to ASCII Please see the Exporting Data section in the Starting/Running Procedure section.

EP Summary Window This window allows all the traces for an EP or MEP mode to be displayed, not just the traces that are closely associated with an event, like the Event Window. This should provide a convenient way to review and print all the traces for a procedure. 209

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If you do not want a trial to be included in a Summary Window report, un-check the box associated with that trial. Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Window Setup

Please see Summary Window Setup Global Window Setup

Please see Global Summary Window Setup Deselect Traces

Returns all selected traces, displayed in "yellow", to their original color. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the 210

Procedure Setup report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output to ASCII

Please see the Exporting Data section in the Starting/Running Procedure section.

MEP Summary Window This window allows all the traces for an EP or MEP mode to be displayed, not just the traces that are closely associated with an event, like the Event Window. This should provide a convenient way to review and print all the traces for a procedure.

Add Marker Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace.

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Elite Operators Manual Window Setup Please see Summary Window Setup Global Window Setup Please see Global Summary Window Setup Deselect Traces Returns all selected traces, displayed in "yellow", to their original color. Copy Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output to ASCII Please see the Exporting Data section in the Starting/Running Procedure

section.

MEP Analysis Window

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EMG Window The EMG window displays EMG data for an EMG mode. The window displays data in a continuous, non-triggered sweep. If the stimulator is enabled, the window displays sweeps triggered by each stimulus. Right-click on the EMG window for a menu list. See below for a description of each of the menu items.

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Run

Starts and stops acquisition for the mode. Single

Fires the assigned stimulator once. Store

Stores the current average. Stim Hold/Stim Rep

Stim Rep (Stimulate Repetitive): Turns repetitive stimulation on/off. Stim Hold (Stimulate Hold): Turns Stim & Hold mode on/off. When on, the EMG mode fires the stimulator at the specified reprate and displays single sweeps triggered by each stimulus. When unchecked, the EMG mode runs in the default, free run mode. When this box is checked, the Repetitive checkbox is automatically checked and disabled. Mode Setup...

Displays the Mode Setup window for the EMG mode. Allows you to change all functions of the EMG mode. Refer to the Mode Setup section for more information.

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Opens the EMG Threshold Setup dialog. Trace Labels

When checked, channel labels are displayed next to the traces. Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Threshold Markers

When enabled, the threshold setting for each channel is indicated by yellow markers. Deselect Traces

Returns all selected traces, displayed in "yellow", to their original color. Clear Captured Trace

Resets the auto-captured trace to a flat line. Window Setup

Allows you to set window options for the EMG window. Refer to the Windows Setup section for more information. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. When the EMG window is selected, an EMG toolbar will be shown at the top of the screen. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output Traces to ASCII

Please see the Exporting Data section in the Starting/Running Procedure section. Pane Selection

Click the drop down arrow to select Single Pane, Vertical Split, or Horizontal Split.

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Single Pane - all EMG traces are displayed in one window.

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Vertical Split - traces for left side muscles are displayed on the left half of the window, traces for right side muscles are displayed on the right half of the window.

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Horizontal Split - traces for the left side muscles are displayed on the top half of the window, traces for the right side are displayed on the bottom half of the window.

NOTE: To specify whether a trace should be Left or Right, see Channel Settings under EMG Mode Setup.

EMG Buffer

When the EMG mode is stopped, you can review back through a buffer of the last 20 sweeps by clicking along the timeline at the bottom of the window.

Stacked EMG Window

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Procedure Setup This window displays a list (stack) of every stored EMG sweep. The list along the right side of the window shows the time and stimulus intensity for each triggered EMG. To access the Stacked EMG Window, open a procedure which includes EMG. On the toolbar, click Edit, then select View Setup. Under the AVG/EMG tab, click the box next to EMG: Stacked EMG. A "trial number" is assigned to each EMG waves as it is stored. The trial number can be displayed on the window as bracketed numbers (see Stacked EMG Window Setup for more display options).

If you do not want a trial to be included in a Summary Window report, un-check the box associated with that trial. The right click menu for the stacked EMG window is similar to that of the EP summary window. Add Marker Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window.

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Elite Operators Manual Amplitude Markers Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Window Setup Please see Summary Window Setup Deselect Traces Returns all selected traces, displayed in "yellow", to their original color. Check All Trials Selects all of the stored EMG traces for a report. Uncheck All Trials Deselects all of the stored EMG traces for a report. Allows you to select just the trials you want on your report. Copy Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Select this option to specify a template and generate a report.

When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output Traces to ASCII Please see the Exporting Data section in the Starting/Running Procedure section.

MEP Triggered Window The MEP Triggered window displays Live, and Stored traces from an MEP mode. It allows you to display 0 to 10 stored trials in a trend fashion. You can also place and move cursors on traces and display time and amplitude markers. The MEP Triggered window also allows you to set baseline trials. Tip: You can change the trace gains by selecting a trace and spinning the mouse wheel.

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Trigger

Causes the assigned MEP stimulator to deliver one stimulus train. Store

Stores the current average. Clear

Clears the current average. Reject

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Elite Operators Manual When artifact reject is enabled, the reject percentage value is displayed in the window. If the amplifier gain setting is 10 uV/division this means that the Live trace has an amplitude window of 100 microvolts (10 vertical divisions times 10 uV/div.) with 50 uV above baseline and 50 uV below baseline. If the reject level is set to 50%, then the amplitude of the Live trace can’t exceed +/- 25 uV or it will be rejected from the running average. The lower the reject level setting the more sensitive the program will be in rejecting large artifacts. Add Time Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Set Baseline

Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Auto Place Cursors

If no traces are selected (yellow) then cursors are automatically placed on the live traces (white). Otherwise they are placed on the selected trace. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

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Clears the cursors from the selected trial/trace. Adjust Latency

Available after a trial has been selected. Takes the values for the current positions of the auto-cursors on the selected trial and resets the auto-cursor Start Latency to -90% and the End Latency to +110% of these values. Grand Average

Allows stored trials to be averaged together. This function is only available when more than one stored trial has been selected in the window. The resulting grand average traces, for each channel, are displayed in 'green' color and the trace label will contain the letters 'GA'. Live

When checked, the live, unaveraged traces are displayed. When unchecked, the averaged traces are displayed. Note that this does not affect the display of the stored traces. Trial Select On

When this option is checked, clicking on a trace selects or clears all the traces for a trial. When unchecked, traces are selected individually. Smooth/Unsmooth

Select Smooth to smooth selected traces in EP Windows. Select Unsmooth to reverse smoothing. Delete/Restore Trials

Delete Trials: selected trials will no longer be displayed in the Average view. Restore Deleted Trials: restores all deleted trials. Auto-Position On/Off

When this feature is turned OFF moving the active "white" traces will not automatically re-position the stored or baseline traces, nor will exiting from the Average window’s Setup dialog. The default setting is auto-position turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Select All

This function selects are trials that are currently displayed within the window. Deselect Traces

Returns all selected traces, displayed in "yellow", to their original color. As Recorded Gain

When this feature is turned ON the appropriate display gain will be shown for the Average window as you move back through the recording timeline. When this feature is turned OFF, the display gain will not change but will remain at its current setting when moving back through the timeline. The default setting is As 221

Elite Operators Manual Recorded Gain turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Window Setup

See MEP Window Setup Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Copy Cursor Table

Copies a text version of the cursor table information to the Windows clipboard. The information can be pasted into a word processor or spreadsheet. The table includes cursor values for each of the stored trials, displayed in the Average window. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

Live EEG Window The Live EEG Window displays live EEG data in a sweeping fashion from left to right across the window. When this window is active, the EEG toolbar is displayed at the top of the screen. The toolbar has controls for changing the Display Gain and the Sweep Speed of the window (the Display Gain units are in microvolts per vertical division and the Sweep Speed units can are in milliseconds per horizontal division).

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Run

Starts and stops acquisition for the mode. Set Epoch Length

CSA/DSA epoch length may be adjusted by right clicking in the main EEG data window and selecting the desired epoch length from the Epoch length sub menu. s can select from choices of 2, 4, 8, 16, and 32 seconds. EEG Window Setup

Controls in this window are used to turn the trace labels, burst suppression calculation, graticule, or division units on or off. The sweep speed and the channel display gain settings can also be adjusted. Please refer to the EEG Window Setup Section for more information. Scrolling Options

The EEG window can draw the EEG traces in one of four methods. 10 Divisions - creates 10 equal horizontal divisions across the width of the EEG window, no matter what the sweep speed setting is. 10 mm/sec - draws the EEG at a rate of 10 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting. 15 mm/sec - draws the EEG at a rate of 15 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting. 223

Elite Operators Manual 30 mm/sec - draws the EEG at a rate of 30 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting. Trace Labels

When checked, channel labels are displayed next to the traces. Deselect Traces

Returns all selected traces, displayed in "yellow", to their original color. EEG Lookback

Splits the Live EEG window into two sections. The section on the right will continue to show the live EEG traces. The section on the left can be used to review back through the EEG by using the horizontal scroll bar. Please refer to the EEG Lookback page in the Starting/Running Procedures section for more information. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print

Select this option to generate an EEG report.

Select Print Current window to generate a report with just the traces from the current EEG window. Select Print range to generate a report that includes all the EEG traces over a specified time range. Output Traces to ASCII

Please see the Exporting Data section in the Starting/Running Procedure section. EEG Toolbar:

Paging Controls

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Procedure Setup Use these toolbar buttons to go forwards/backward by one page or by one half page. Click on the middle button to return the display to Live EEG.

EEG Analysis Window The EEG Analysis window displays analyzed EEG data in several different formats. Below is data displayed in CSA, DSA, Symmetry, Trend and Burst Suppression views. EEG analysis windows display event ticks vertically along side the data. The event ticks are the same event ticks that show up in the time bar at the bottom of the Cascade window. A text box is displayed containing the text of the event when the mouse is rolled over the event tick. The current spectral edge frequency is displayed at the top of each channel window. The spectral edge frequency of the baseline epoch is represented by a yellow tick mark at the bottom of each channel window The epoch length of the EEG analysis may be adjusted by right clicking in the EEG Analysis window and selecting the desired epoch length from the Epoch length sub menu. s can select from choices of 2, 4, 8, 16, and 32 seconds. NOTE: You can make a copy of the Analysis window and have one window set up to display DSA data and have the other window set up to display CSA data simultaneously in the same View: see the CSA/DSA views.

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3D Trend Window The 3D Trend windows display a selected trace from an EP mode in order to monitor changes in the response over the course of the surgery. The Z-axis is based on time. You can change the orientation of the graticule by dragging the upper left or lower right corners.

Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Set Baseline

Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected.

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Procedure Setup As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Freeze

The Z-axis depicts the last n minutes of data. Normally, you will see traces "walk" up the display. When this option is checked, the traces are frozen in place and do not move. Window Setup

Please see 3D Trend Window Setup Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

Cursor Trend Window The Cursor Trend window allows you to display a histogram of up to 4 cursor measurements for an EP Mode. The measurements that you can display are based on the cursor table setup for the mode (see Setting Up Cursor Tables). The window displays the stored trial/trace cursor values in either a graphical Dot-To-Dot format or in a scrolling Table format. You can toggle between the two display types at any time by using the right click menu. The current baseline values are displayed all the time at the bottom of the window, and the percentage difference between the baseline and most recent data point is calculated and displayed. Below are two examples of the Cursor Trend window: the Table view and the Dot-toDot view. Please refer to the Glossary for descriptions of each of the menu items below.

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Table view Dot-to-Dot/Table View

Dot-to-Dot/Graph View: Dots mark the cursor values with a straight line between them. This view tracks the Time Bar repositioning. Table View: This option displays a continuously updated table of values for each feature selected. The table contains all values that have been collected, baseline values, events, and the time, value, and percent difference from the baseline for each cursor value. This view also tracks the Time Bar repositioning. Show Baseline

This option for each column in a Cursor Trend window shows the current baseline value for the feature being trended, and is displayed as a line at the bottom of the display. When the "Display Baseline Value" option is turned on, a value is displayed which is the difference between the baseline value and the most recent value. This value is displayed as a percentage. For example, if the baseline value is 5.0 and the current value is 4.0, the value displayed will be -20.0%. If the current value is 7.5, the value displayed will be 50.0%. Show Events

Select this option to display the event text in the Cursor Trend window. Show Percents

Select this option to display the percent change, or the percentage difference between the baseline and most recent data point, in the Cursor Trend window. Window Setup

Please see Setting up Cursor Tables. EP Cursor Trend Window Setup

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Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

Dot-to-Dot view (vertical trend) NOTE: Normal dots are displayed in the same color specified for EP Cursors in System Setup. The line connecting the normal dots is the same as the color specified for the Stored Trials. The color of the baseline dot is the same as that specified for the Baseline Trace. Abnormal dots are always displayed as red squares.

Dot-to-Dot/Table View

Dot-to-Dot/Graph View: Dots mark the cursor values with a straight line between them. This view tracks the Time Bar repositioning.

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Elite Operators Manual Table View: This option displays a continuously updated table of values for each feature selected. The table contains all values that have been collected, baseline values, events, and the time, value, and percent difference from the baseline for each cursor value. This view also tracks the Time Bar repositioning. Horizontal Trend

When enabled, the Dot-to-Dot trend is drawn horizontally rather than vertically. Show Baseline Dot-to-Dot

This option for each column in a Cursor Trend window shows the current baseline value for the feature being trended, and is displayed as a 'blue dot' at the bottom of the display. When the "Show Baseline" option is turned on, a value is displayed which is the difference between the baseline value and the most recent value. This value is displayed as a percentage. For example, if the baseline value is 5.0 and the current value is 4.0, the value displayed will be -20.0%. If the current value is 7.5, the value displayed will be 50.0%. Dot-to-Dot Markers

Center Marker on Baseline: centers a vertical time marker on the baseline value. Center Marker: centers a vertical time marker within the x-axis of the trend. Place Marker at x% of Baseline: positions a vertical marker at +10% (latency trend) or -50% (amplitude trend) of the baseline value. Zoom In/Zoom Out

Use these options to quickly modify the range of values displayed in the graph. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

Video Window The Video Window displays live video from a camera connected to the computer. Various settings allow you to specify when video images are stored to the data file for later review.

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Procedure Setup Continuous video is not stored to the file; only "snapshots" are stored based on these settings. You can use multiple video windows, if more than one camera is available.

Take Snapshot

Stores the current video image to the file. A Comment box displays each time a snapshot is taken. Refresh

Updates the image in the window. Window Setup

Please see Live Video Window Setup Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

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Elite Operators Manual The Event Window displays up to four traces from the available EP or MEP modes. When you enter an event, the event text shows up in the Event Window along with the stored traces for the time of the event. The result is a summary of responses at key points during surgery. Note that the event text is always displayed, but duplicate traces are not. Tip: You can change the trace gains by selecting a trace and spinning the mouse wheel.

Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Window Setup

Please see Event Window Setup Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Copy Special

Applies filtering to the Copy command. You can select only the data you want to see based on priority, type of event, and individual events. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to 234

Procedure Setup select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

Waterfall Window The Waterfall Window displays the stored traces for a determined amount of time (trend time), in a two-dimensional stack. Time (in minutes) is displayed on the Y axis. The sweep speed is on the X axis. The traces can be trended in ascending or descending modes. The ascending mode, the most recent stored trace appears at the bottom of the graph and moves upward as new traces are added to the stack. The descending mode, the most recent stored trace appears at the top of the graph and move downward. The current time of day is displayed at the top (descending mode) or bottom (ascending mode) of the Y axis.

Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

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Elite Operators Manual Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Window Setup

Please see Waterfall Trend Window Setup Global Window Setup

Please see Global Waterfall Window Setup Set Baseline

Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output to ASCII

Please see the Exporting Data section in the Starting/Running Procedure section.

TOF (Train of Four) Trace Window

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Procedure Setup This window displays each response in the stimulus train and shows the peak and trough cursors on each trace. Besides showing the most recently acquired train it can also trend up to 10 previously stored trains and can also display a baseline train. By right-clicking on the window you can perform various functions including accessing the Mode Setup and window Setup.

Options Run Starts and stops acquisition for the mode. Single Fires the assigned stimulator once. Store Stores the current average.

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Elite Operators Manual Clear Clears the current average. Mode Setup Accesses frequently changed parameters for the mode. Add Time Marker Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Set Baseline Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Auto Place Cursors If no traces are selected (yellow) then cursors are automatically placed on the live traces (white). Otherwise they are placed on the selected trace. Show Cursors Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information. Clear Cursors Clears the cursors from the selected trial/trace. Deselect Traces Returns all selected traces, displayed in "yellow", to their original color. Window Setup Please see TOF (Train of Four) Analysis Window. Copy Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

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Procedure Setup

TOF (Train of Four) Analysis Window By right-clicking on the analysis window you can switch between the table or histogram view, turn On/Off various calculations, enter the setup window, and create a report.

Table View: Displays a numeric trend of a the measures selected in the Shoe area of the window setup. Histogram View: Displays select data in a graphical form Show Count: Displays a count of the number of responses in the train of four. Amplitude: Calculations of TOF% and T1% are based on the amplitude of the responses. Area: Calculations of TOF% and T1% are based on the area under the curve of the responses TOF% = amplitude or area increment or decrement between the first and the fourth response in the train. If no fourth response is detected this value will always be 0%. T1% = amplitude or area increment or decrement between the first response in the most recent train to the first response in the baseline train. Show Baseline: Displays the baseline traces in the window. Window Setup

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Elite Operators Manual Displays view options that can be changed. Most of which are in the context (right click) menu. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window.

View Setup and Mode Windows Setup Views Overview View Setup Overview A view is a collection of mode windows. There will always be at least one view. You may display as many mode windows per view as you like. View Setup defines which windows to display, the window sizes, and window positions. You can define as many views as needed and create copies of mode windows and have two mode windows showing the same data in slightly different ways. For example, you may set up a view which shows only the Average windows for each EP mode and another view which shows the Cursor Trend windows. During surgery, you can switch to the Cursor Trend view to monitor trending. Data collection continues even though the Average windows are not displayed. The View Setup dialog is available in the procedure setup and edit current procedure setup dialogs and Edit menu using the View Setup option. Windows for each view are listed based on the modes you have defined in the Mode section. Each mode window in the View list can be customized using the Mode Window Setup dialog. See the Mode Windows Setup Overview section for options available when setting up each mode windows type.

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Procedure Setup

Views

Views are groups of Windows. You can have multiple Views each with a different set and arrangement of Windows. Add/Delete/Rename View Buttons

Click the Add View button to enter an additional view. Click the Delete View button to delete the active View. Click the Rename View button to rename the active View. Layout Windows Button

Click the Layout Windows button to view the layout and set the default positions of all of the checked windows in the view list. You can move windows and change the size of the windows. Left-click and hold on the edge or a corner of a window and drag to resize the window. Left-click and hold on the title bar to move the window. See the Window Menu for more information on window options. Re-arrange Views

To re-arrange the order of the Views, simply click on the appropriate view's tab and drag to a new location. A black line indicates where the view will be moved to when the mouse button is released.

Mode Windows Setup Overview Each mode window in the View list can be customized using the Mode Window Setup dialog. You may access this dialog three ways. When in Procedure Setup, highlight the window you would like to edit and click the Windows Setup button. While running a procedure, right click on the window you would like to edit and choose the Window Setup option. While running a procedure, choose View Setup from the Edit menu, highlight the window you would like to edit and click the Windows Setup button.

Mode Control Window Setup The Mode Control window behaves much like any other window. The Mode Control window can be omitted from a view and like any other window and you may select the elements to show in the Mode Control window.

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Elite Operators Manual To omit the Mode Control window from a view, simply uncheck the Mode Control window in the View Setup dialog. Refer to the Cascade manual or help file for instructions for using the Vie Setup option. To select which elements to show in the Mode Control window, select Window Setup from the View Setup window, by right clicking the Mode Control window name in the view list or by right clicking the Mode Control window while running a procedure. By default the all mode controls are shown in the Mode Control window and the Mode Control window is turned on. Mode group controls will always be shown in the Mode Control window and cannot be omitted from the Mode Controls window. Be aware that stimulus intensity controls are available only in the controls for the individual modes.

EP Average Window Setup To access Average Window Setup, scroll down through the Available Windows in the Views section of Procedure Setup, highlight the "Average" window, and click Window Setup.

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Procedure Setup

The Window Setup options include:

Show Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Trace Labels

When checked, channel labels are displayed next to the traces. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

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Elite Operators Manual When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting. Average Count

A counter that shows the number of sweeps collected during waveform averaging. Reject

When artifact reject is enabled, the reject percentage value is displayed in the window. If the amplifier gain setting is 10 uV/division this means that the Live trace has an amplitude window of 100 microvolts (10 vertical divisions times 10 uV/div.) with 50 uV above baseline and 50 uV below baseline. If the reject level is set to 50%, then the amplitude of the Live trace can’t exceed +/- 25 uV or it will be rejected from the running average. The lower the reject level setting the more sensitive the program will be in rejecting large artifacts.

Waveforms Display Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase Trend Count

Specifies the number of stored trials to display. Stored trials are displayed in a trend fashion with the most recent trial at the bottom.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Auto Position On-Off

When this feature is turned OFF moving the active "white" traces will not automatically re-position the stored or baseline traces, nor will exiting from the

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Procedure Setup Average window’s Setup dialog. The default setting is auto-position turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Trial Select

When this option is checked, clicking on a trace selects or clears all the traces for a trial. When unchecked, traces are selected individually.

Channel Channel Section

Allows you to set the display gain for traces and turn them on or off. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

EMG Window Setup To access EMG Window Setup, check and then highlight the EMG Available Window in Views and click Window Setup.

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Show Graticule:

Select or deselect to show graticule.

Left/Right •

Single Pane - all EMG traces are displayed in one window.

•

Vertical Split - traces for left side muscles are displayed on the left half of the window, traces for right side muscles are displayed on the right half of the window.

•

Horizontal Split - traces for the left side muscles are displayed on the top half of the window, traces for the right side are displayed on the bottom half of the window.

Display Gain Use Display Gains:

Select Use Display Gains to adjust the display gain knob.

Channel Channel:

To temporarily remove a channel from the window, un-check the corresponding box. The channel is still included in the mode. It is simply not shown in the window. This is important when running NerveGuard. NerveGuard will trigger off any channel in the mode regardless of whether or not that channel is turned on in the Window setup. You can record and display EMG data at different gains for the same EMG channels in different EMG modes without duplicating EMG channels in the montage list. For example, you may want to use the same set of EMG channels to perform pedicle screw stimulation at 200µv/div, record free-run EMG at 50µV/div and record train of four recordings at 500 µv/div. To use this feature, turn on the Use Display Gain option in the Window Setup or in the Mode Setup window of the EMG mode and set the channels to the desired display gain. When Display Gains are on, the amp gain dial is grayed out. When the Display Gains are off, the display gain dial is grayed out. The Mode Setup window will show the amplifier gain when the display gains are turned on. Because the display gain is based on the amplifier gain, it is recommended that amplifier gains be set no lower than the largest display gain in any mode. For example, if you are running free-run EMG at 50uV/div and triggered EMG at 200uV/div, the amplifier should be set to 200uV/div. The Use Display Gains box is also available in the Mode Setup window.

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Procedure Setup On an MEP mode window, right-click and select Window Setup to display the setup dialog.

Show Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Trace Labels

When checked, channel labels are displayed next to the traces. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

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Elite Operators Manual When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting. Average Count

A counter that shows the number of sweeps collected during waveform averaging. Reject

When artifact reject is enabled, the reject percentage value is displayed in the window. If the amplifier gain setting is 10 uV/division this means that the Live trace has an amplitude window of 100 microvolts (10 vertical divisions times 10 uV/div.) with 50 uV above baseline and 50 uV below baseline. If the reject level is set to 50%, then the amplitude of the Live trace can’t exceed +/- 25 uV or it will be rejected from the running average. The lower the reject level setting the more sensitive the program will be in rejecting large artifacts.

Waveforms Display Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase Trend Count

Specifies the number of stored trials to display. Stored trials are displayed in a trend fashion with the most recent trial at the bottom.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Auto Position On-Off

When this feature is turned OFF moving the active "white" traces will not automatically re-position the stored or baseline traces, nor will exiting from the

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Procedure Setup Average window’s Setup dialog. The default setting is auto-position turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu. Trial Select

When this option is checked, clicking on a trace selects or clears all the traces for a trial. When unchecked, traces are selected individually.

Channel Allows you to set the display gain for traces and turn them on or off. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

Live EEG Window Setup Controls in this window are used to turn the trace labels, burst suppression calculation, graticule, or division units on or off. The sweep speed and the channel display gain settings can also be adjusted.

Show Trace Labels

When checked, channel labels are displayed next to the traces. 249

Elite Operators Manual EEG Burst Suppression

The Cascade has three options for computing and display EEG Burst Suppressions. •

Suppression Ratio (%) - the percentage of time spent in suppression during the previous minute.

•

Bursts Per Minute (b/m) - number of bursts that began during the previous minute.

•

Burst : Suppression - the ratio of time not in suppression to the time in suppression during the previous minute.

Definitions

Suppression - an interval of at least 1 second during which there is no activity above threshold. Burst - a period of time in which the threshold is exceeded with a specified degree of frequency. Algorithm

The EEG data is filtered using an 8 Hz locut filter. The algorithm then begins looking for bursts and periods of suppression using the following rules: •

A burst is a segment more than 700 msec long that exceeds 8 uV in amplitude. If the burst is less than 700 msec, it is considered a noise spike.

•

Bursts must be separated by at least 150 msec, or they are counted as a single burst.

•

If the flat area between bursts is at least 1 second long, then that time is counted as suppression.

The Burst Count and Suppression % are calculated for each individual 10-second epoch. The values that are displayed in the EEG window are the total count for the last minute, or the average suppression % for the last minute. If the Suppression % is less than 25%, then the program assumes that the patient is not yet in burst suppression, and doesn't display the value. The EEG Analysis window shows yellow dots (trend view) for values that are calculated from less than a minute of data (which can occur if the mode is stopped and restarted). Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

Waveforms 250

Procedure Setup EEG Drawing Selections

The EEG window can draw the EEG traces in one of four methods. •

10 Divisions - creates 10 equal horizontal divisions across the width of the EEG window, no matter what the sweep speed setting is.

•

10 mm/sec - draws the EEG at a rate of 10 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

•

15 mm/sec - draws the EEG at a rate of 15 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

•

30 mm/sec - draws the EEG at a rate of 30 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

Display Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Display Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase

Channel Channel Section

Allows you to set the display gain for traces and turn them on or off. Show Burst Suppression Info

Enables the display of burst suppression calculations for the channels that are checked. All Gain Control

Use the up/down buttons to change the display gain of all channels at one time.

Event Window Setup To access Event Window Setup, select and highlight Event Window in the Views section of Procedure Setup, or, on the Event Window, right-click and select Setup.

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Trace Windows

Trace Window 1-4 specifies which trace to display, if any. The drop-box lists all traces from all EP modes. Display Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase Display Gain

The display gain is the input sensitivity of the instrument when data is being collected. This sensitivity determines the vertical scale of the input as displayed on the test screen when set to view the input signal during acquisition. You can adjust gain settings (as well as sweep speed) to ensure proper display of the signal. You can adjust the gain setting independently in each channel. Gain is measured in microvolts per division (uV/div). Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information. Show In Trace Windows

Graticules: Shows/Hides the graticule in the trace display windows. Trial Numbers: Shows/Hides the trial number in the trace display windows. Division Units: When checked, the current sweep setting displays in the lower right corner of the window. The current gain setting also displays in the lower left corner if all traces have the same gain setting. ‘Mode Trace‘ Labels: Shows/Hides labels of mode trace names. Baselines: Shows/Hides baselines. When baselines are selected they are automatically placed at the bottom of the selected trend window. Event Text

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Procedure Setup Show: Shows/Hides display of the event text Time: Specifies whether to show the elapsed time, real time (time of day), or no time, when displaying event text. Setup Filter

From the Event Window Setup window, click the Setup Filter button to display a list of filters. The default option shows all priorities and event types, but you can deselect any items that you don’t want to display. Cursor

Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Setup Tables

Select the cursors that will be included in the reports, and select whether you want to include baseline information. Default Button

Sets the first Trace Window to the first channel of the first mode. It sets the sweep to Default, which tracks the mode’s sweep setting, and sets the gain to 2. When waveforms are turned off in the Event Window, the event text is automatically adjusted to the full width of the window, the text is wrapped and the text is spaced to the row height of the longest event text. This allows you to customize the event window size while presenting text in a compressed, space-saving manner. This is especially useful when logging long entries such as anesthesia data and conversations with the surgical team.

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To setup an event list like the one shown above, create a copy of an Event Window using the View Setup dialog accessed from the Edit menu. Rename the new window “Event List.” Turn off all waveforms in the Window Setup dialog and click okay. Resize the window to the desired size.

Summary Window Setup The summary window setup dialog allows you to adjust the visible properties of your summary window, choose your channels, adjust your display gain, and change the cursor labels and trend time. To access the Summary Window Setup, select and highlight the Summary window in the Views section of Procedure Setup, and click Window Setup.

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Procedure Setup

Show Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting. Events

Enter specific data for the event list you will use during the procedure. 255

Elite Operators Manual Trial Number

When enabled every fourth trial number will be displayed on the traces. All Trial Times

When enabled the trial times will be displayed in the far right-hand column. Channel Names

When enabled the channel names will be displayed in the top left of each trace window.

Waveforms Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total, therefore: sweep speed x 10 = total timebase Trend

Specifies the number of minutes to display in the window. If the window size is not large enough to accommodate the full trend time, a scroll bar will be presented allowing the to scroll through the entire trend time. Spacing

Specifies the space between traces.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Channels On

Allows you to set the display gain for traces and turn them on or off. Display Gain

Sets the display gain for each channel. Show Cursors

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Procedure Setup Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information. All Gains

Allows you to adjust the gain of every channel within the window setup.

Waterfall Trend Window Setup

Show Minutes Labels:

Shows/Hides the minutes labels. •

Graticule: Shows/Hides the values for all three axes.

•

Baseline: Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window.

Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. 257

Elite Operators Manual Trace Name:

Shows/Hides the label of the trace displayed. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

Waveforms Trace:

Selects which traces are displayed. Sweep:

Specifies at what sweep to display the traces. Note that this value does not effect the mode sweep setting. Select Default if you want the sweep to track the mode sweep setting. Gain:

Specifies the display gain for the trace. Trend:

Specifies how many minutes the Z-axis displays. This is the amount of past time the window displays. Order:

Determines whether the time is ascending or descending. Ascending order displays the most recent traces at the bottom of the window with the oldest traces at the top of the window. Descending order displays the most recent traces at the top of the window with the oldest traces at the bottom of the window.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Channels On

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Procedure Setup Allows you to turn channels them on or off. This setting only determines which traces are displayed. When channels are turned off, the mode continues to record from that channel. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

Global Summary Window Setup Use the selections in this window to change common settings for all Summary windows at one time. This window is accessible from the right-click menu in the summary window while running. This window is not accessible from the procedure setup screen.

Show Baseline Trace Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Graticule When checked, the graticule or grid is visible in the selected window. Division Units When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting. Events Enter specific data for the event list you will use during the procedure. Trial Number When enabled every fourth trial number will be displayed on the traces. All Trial Times When enabled the trial times will be displayed in the far right-hand column. Channel Names When enabled the channel names will be displayed in the top left of each trace window.

Waveforms Display Sweep Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: 259

Elite Operators Manual sweep speed x 10 = total timebase

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: • All Off: no cursors are displayed. • Crosshair Only: the crosshair (+) is displayed without a label • Label and Crosshair: both the label and crosshair are displayed • Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed • Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Channels Allows you to set the display gain for traces and turn them on or off. Show Cursors Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

EP Cursor Trend Window Setup Access From Procedure Setup: In the Views section of the Procedure Setup file, select and highlight the Cursor Trend window for a given EP mode and click the Window Setup button to the right. From a Procedure: Within an open procedure, right-click in the Cursor Trend Window for an EP mode and select Window Setup from the menu.

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Display Mode Choose Table View or Dot to Dot Graph for displaying the cursor trend information in your procedure. They can be selected in the right-click menu while running the procedure or in the Cursor Trend Window Setup. You may also change the display mode of the Dot to Dot Graph to stacked windows by checking the Horizontal Trend box in the Cursor Trend Setup.

Trends Feature: Click the drop-down arrow to select the desired feature to trend for up to four features. The features available to trend are defined in the Cursor Table for each EP mode, and are the Latencies. Amplitudes and Inter-Latencies are defined from the cursors you select for that EP mode. If additional features need to be trended for an EP mode, insert a copy of the mode in the Views section of the Procedure Setup and make necessary changes. Channel: Select or change the recording channel only if the Trial Mode Cursors box in the Cursor Table is not selected in the cursor table for the EP mode. Center: Defines the center point for latency and amplitude shifts in the Dot to Dot Graph display mode. 261

Elite Operators Manual Range: Defines the display axis for the trend feature selected in the Dot to Dot Graph display mode. The Trend Time defines the other axis. Marker: Check this option for the ability to place a marker in the Cursor Trend window of Dot to Dot Graph display mode. Right-click within an open procedure to place a marker. LockGraph: Locks the X/Y axes in place in the Dot to Dot Graph. When deselected, the X/Y axis can be click-and-dragged within the Cursor Trend Window. The latency range on the Y axis can also be changed with a click-anddrag. Norm%Change: This is the warning flag setting. When the selected trend exceeds the acceptable change form the baseline, the text in the Cursor Trend Table display mode will appear in red as an alert.

Show Show Baselines: If selected, a time stamp will be displayed with trend values in the Cursor Trend Table display mode. This option can also be turned on and off in the right-click menu of the EP window in a procedure. Show Events: If selected, a time stamp will be displayed with a comment in the Cursor Trend Table display mode. This option can also be turned on and off in the right-click menu of the EP window in a procedure. Show Percents: If unselected, the %Change columns will no longer be displayed in the Cursor Trend Table display mode. This option can also be turned on and off in the right-click menu of the EP window in a procedure. Time, Elapsed or Real: In Cursor Trend Table, time can be displayed in Elapsed or Real time. In the Dot to Dot Graph, time is displayed in trend time and its increments can be adjusted.

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Live Video Window Setup The Live Video Window Setup allows you to change the refresh rate at which your images are stored.

Access or Add Live Video Window to View From a procedure: 1. Open the Edit toolbar menu and click Edit Views. 2. Checkmark the Live Video option. 3. Click Window Setup to access the Live Video Window Setup. 4. Adjust your option settings. 5. Click OK. 6. Click OK to add Live Video Window to the procedure view.

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Options Source Select: Select a camera from the drop-down menu. Refresh Rate: Choose a refresh rate. This visual option gives a higher quality when a higher frames per second (fps) is selected. Image Type: For a faster frame rate, use I420. For color correctness, use IYUV. Resolution: Set pixels between 160x120 to 640x480. The higher the resolution, the better the image will appear. Store Image On... Interval: Set how often the data is stored to file, from 12 frames per minute (fpm) to 6 frames per hour (fph). Event: Automatically capture an image when an event occurs within the procedure. EP Average: Automatically capture an image when the evoked potential averages and stores data. EMG Store: Automatically or manually capture an image when you store traces for EMG. Default: This option sets the refresh rate and interval. The image type and resolution will remain as manually set. OK: Save and close Video Window Setup. Cancel: Close Video Window Setup without saving changes. NOTE: If you make a copy of the Video Window in the Views section of Procedure Setup and select a different camera in its Source Select, you may operate and monitor two cameras at once during a procedure.

EP Analysis Window Setup

The EP Analysis window is used to perform Digital Filtering and FFT analysis on stored evoked potential traces. This window can be added to any existing View by selecting View Setup from the Edit menu.

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Procedure Setup

Features: Each Evoked Potential acquisition mode, in the procedure setup, will have an EP Analysis window available. Channel Select

The must select the Channel from a drop-down control. The analysis is automatically performed on the most recently stored trial for the selected channel and mode, and automatically updates as new trials are acquired and stored. In 265

Elite Operators Manual order to go back and re-perform analysis on earlier traces the can simply go back anywhere along the procedure’s timeline. Trace Scaling

Click the mouse within the trace area and use the mouse wheel to change the display gain.

Digital Filter Section: Locut and Hicut

As soon as a stored trace is available for the selected Mode a copy of the stored trace is automatically drawn in the Digital Filter window (original) along with a second trace that is digitally filtered (filtered) according to the Locut and Hicut filters that have been specified. The can change the Locut and Hicut settings at any time and the filtered trace is redrawn. The Locut and Hicut default settings are programmable and can be specified in the window’s setup menu. Perform Area & RMS On

can specify that either the “Original” or “Filtered” trace be used for the RMS and Area calculations. Area and RMS

The Area under the curve and Root Mean Square voltage are both calculated for the specified trace. The units for Area are uVms (microvolt milliseconds) and the units for RMS are uV (microvolts). The can change the From and To values in order to perform the calculations on selected portions of the trace. The From and To values always default to the entire timebase of the selected trace. Expand Feature

The can click on the upper and lower sweep settings and change the values. This will expand the trace to the new settings. This does not affect the FFT graph, the FFT is always computed on the entire length of the selected trace.

FFT Section: Perform FFT On

The can select either the “Original” or “Filtered” trace for FFT analysis. Window

can specify “None”, “Blackman” or “Hanning” for the time domain windowing algorithm. X-Axis (frequency)

The maximum frequency that can be resolved will be half of the trace’s sample rate (Nyquist rule). At 1.0 millisecond per division this would be 32,000 Hz. At 100 milliseconds per division this would be 320 Hz. The x-axis defaults to display between zero and the maximum frequency allowed. The can at any time change the upper and lower frequency values in order to “zoom in” on the FFT. If either of the frequency values change, the FFT is automatically redrawn. 266

Procedure Setup Y-Axis (voltage or power)

Either voltage (uV) or power (uV2) can be displayed on the vertical axis. The can switch units simply by clicking on the unit field. Initially the FFT is drawn so that the highest peak in the FFT is viewable. The can change the maximum for the Y-axis and the FFT is automatically redrawn. FFT Cursor

When the mouse is positioned over the FFT a “pop-up” will display the frequency and voltage/power of the data point nearest to the mouse pointer. See example below.

FFT Marker

By right clicking over the FFT the can enable an FFT Marker. The marker can be positioned anywhere within the FFT simply by dragging it with the mouse, it always displays the frequency and voltage/power at its location. See example below.

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Elite Operators Manual FFT Resolution:

The Cascade stores 640 points per trace. In order to perform the FFT the number of points needs to be reduced to 512 or increased in powers of 2. We have chosen to artificially increase the FFT resolution by adding points to the data. What this does is pad the sample with additional data points thereby increasing the resolution of the FFT. The window defaults to 1024 points and can be changed to 2048 points. Reports:

Right click on the EP Analysis window and select Print. Use the “EP Analysis.rpt” template. An example of the EP Analysis report is shown below.

Stacked EMG Window Setup The stacked EMG window displays stored EMG traces is a stacked format similar a summary window. Trace time stamps and event comments may be displayed in the margin of the window. EMG comments are not displayed in the stacked EMG window.

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Procedure Setup

To access the stacked EMG window setup, select then highlight Stacked EMG in the Views section of Procedure Setup and click Window Setup.

Show Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

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Elite Operators Manual Intensity When checked, the stimulus intensity used with triggered EMG traces is displayed in the margin of the stacked EMG window. Events

Enter specific data for the event list you will use during the procedure. Trial Numbers

When enabled every fourth trial number will be displayed on the traces. All Trial Times

When enabled the trial times will be displayed in the far right-hand column. Channel Names

When enabled the channel names will be displayed in the top left of each trace window.

Waveforms Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total, therefore: sweep speed x 10 = total timebase Trend

Specifies the number of minutes to display in the window. If the window size is not large enough to accommodate the full trend time, a scroll bar will be presented allowing the to scroll through the entire trend time. Spacing

Specifies the space between traces.

Channels On

Allows you to turn channels them on or off. This setting only determines which traces are displayed. When channels are turned off, the mode continues to record from that channel. Display Gain

Sets the display gain for each channel. T All Gains

Allows you to adjust the gain of every channel within the window setup.

EEG Analysis Window Setup

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Procedure Setup Frequency and power information for analyzed EEG data can be displayed in a variety of formats. The Setup window is used to configure this format. Below is the EEG Analyze setup window with menu options. Click on a field below for more information.

General EEG Analysis View

Select one of the following trends for the data presentation type: CSA: Compressed Spectral Array DSA: Density Spectral Array Symmetry: DSA trends with symmetry trends plotted down the middle of the display Trend: Power trends Frequency Range (Hz)

Select the low and high frequency limits for the horizontal axis. The lowest setting is 1.0 Hz and the highest setting is 30 Hz. Trend Time

Determine the amount of data displayed in the vertical axis; for example, the last 10 minutes of data. Channel Labels

Shows/Hides the channel labels in the window. Spectral Edge

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Elite Operators Manual Shows/Hides the spectral edge indicator and selects the spectral edge frequency value (50, 90, 95, 97 or 99 %). Spectral edge is always determined for the total frequency band of 1 – 30 Hz. Voltage, Power, ZScore

Select one of the following options: Voltage: Changes the analysis window to display voltage (microvolts). Power: Changes the analysis window to display power (pW or microvolts squared). Power is the most common setting to use for CSA and DSA displays. Z Score: Changes the analysis window to display the difference (in z-score units) between the trended data and the most recently selected baseline. This is most commonly used with DSA displays. A Z-score of 1 corresponds to a difference of 1 standard deviation. Reject

Shows/Hides the artifact reject algorithm and selects the threshold level for the reject in picowatts (pW). The reject is based on the total power contained in the sampled epoch. If the total power in the epoch exceeds the reject level, then the data for the epoch is not displayed and is replaced by a small "yellow" dash for that point in time in the window. DSA Smoothing

Select to smooth selected traces in EEG Windows. This function is only available when the DSA view has been selected. DTAB (DSA)

This setting causes the DSA trends to be displayed in discrete frequency bands of Delta (1-3.5), Theta (3.5-7.5), Alpha (7.5-12.5), Beta (12.5-25), and High Beta (25-30) Hz. This option is only available when the DSA view has been selected and DSA smoothing is off.

Scale CSA Scale

Increase or decrease the height of the CSA plots. DSA Max Voltage

Set the top level of the color scale when displaying DSA Voltage trends. DSA Max Power

Set the top level of the color scale when displaying DSA power trends.

Channel Selection Use the check boxes to add or remove channels from the display. When the Symmetry View is selected you can specify the channels that are to be compared. Click and drag the appropriate channel label to the desired location to

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Procedure Setup create the pairs that will be analyzed for symmetry. To remove a channel from a pair, drag the channel label to the trash bin. NOTE: Symmetry is a trend showing the absolute difference between the channel on the left vs. the channel on the right.

DSA Colors When the DSA View is selected, these controls can be used to select the color scale.

Z Score Colors When the DSA View and the Z Score items are selected, the Z Score controls can be used to select the Z Score color scale.

Trend When the Trend View is selected, these controls can be used to select the type of data to be trended. Select from Total Power, Absolute Power, or Relative Power. When either Absolute or Relative power are selected, the frequency band can also be selected (Delta, Theta, Alpha, Beta, Delta+Theta, or Alpha+Beta). Range (pW): Sets the maximum limit for the horizontal (x-axis) of the trend displays.

Burst Suppression The Cascade has three options for computing and display EEG Burst Suppressions. Suppression Ratio (%) - the percentage of time spent in suppression during the previous minute. Bursts Per Minute (b/m) - number of bursts that began during the previous minute. Burst : Suppression - the ratio of time not in suppression to the time in suppression during the previous minute. Definitions: Suppression - an interval of at least 1 second during which there is no activity above threshold. Burst - a period of time in which the threshold is exceeded with a specified degree of frequency. Algorithm:The EEG data is filtered using an 8 Hz locut filter. The algorithm then begins looking for bursts and periods of suppression using the following rules: •

A burst is a segment more than 700 msec long that exceeds 8 uV in amplitude. If the burst is less than 700 msec, it is considered a noise spike.

•

Bursts must be separated by at least 150 msec, or they are counted as a single burst. 273

Elite Operators Manual •

If the flat area between bursts is at least 1 second long, then that time is counted as suppression.

•

The Burst Count and Suppression % are calculated for each individual 10-second epoch. The values that are displayed in the EEG window are the total count for the last minute, or the average suppression % for the last minute. If the Suppression % is less than 25%, then the program assumes that the patient is not yet in burst suppression, and doesn't display the value.

•

The EEG Analysis window shows yellow dots (trend view) for values that are calculated from less than a minute of data (which can occur if the mode is stopped and restarted).

TOF Window Setup The TOF (Train Of Four) mode allows for monitoring the patient’s degree of neuromuscular blockade. A train of four stimulations are delivered to the patient and the program automatically records the responses to each stimulus and determines the amplitude and area of each response, if present. Stimulus artifact in the Train of Four mode is suppressed for two milliseconds for each stimulus in the train.

Show Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

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Procedure Setup When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

Waveforms Display Gain

Sets the gain level for the waves displayed on screen. Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase Trend Count

Specifies the number of stored trials to display. Stored trials are displayed in a trend fashion with the most recent trial at the bottom.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and crosshairs are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

•

Setup Tables: allows you to choose the data to include in reports and whether or not to include baselines.

Channel Channel Section

Allows you to set the display gain for traces and turn them on or off. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

TOF (Train of Four) Analysis Window Setup

275

Elite Operators Manual The analysis window can be used to display a trend of a variety of numeric measures of the train of four responses such as Response Count, TOF%, and T1%. The window can also be switched to show a Histogram view of the last acquired train.

Create TOF Analysis 1. In Procedure Setup, add a mode with the mode type Train of Four and name it. 2. In the View section, or from View Setup in the Edit menu of an open procedure, checkmark the new mode Train of Four Analysis option. 3. To make changes to its default options, click Window Setup.

Options Display Mode Table View: Displays a numeric trend of the measures selected in the Shoe area of the window setup. Histogram View: Displays select data in a graphical form Show Count: A count of the number of responses in the train of four. Amplitude: Calculations of TOF% and T1% are based on the amplitude of the responses. Area: Calculations of TOF% and T1% are based on the area under the curve of the responses TOF% = amplitude or area increment or decrement between the first and the fourth response in the train. If no fourth response is detected this value will always be 0%. T1% = amplitude or area increment or decrement between the first response in the most recent train to the first response in the baseline train. Baseline: Displays the baseline traces in the window. 276

Procedure Setup

3D Trend Window Setup On a 3D mode window, right-click and select Setup to display the setup dialog for this window. Click the Default button to set the Trace to the first channel in the mode. This sets the sweep to default, which tracks the mode’s sweep setting, and sets the Gain to 2.

Show The Show section allows you to select the following options: •

Labels: Shows/Hides the axis unit labels.

•

Trace Name: Shows/Hides the label of the trace displayed.

•

Graticule: Shows/Hides the values for all three axes.

•

Baseline: Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window.

Waveforms The Waveforms section allows you to select the following parameters: •

Trace: Selects which trace is displayed.

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Sweep: Specifies at what sweep to display the traces. Note that this value does not affect the mode sweep setting. Select Default if you want the sweep to track the mode sweep setting.

•

Gain: Specifies the display gain for the trace.

•

Trend: Specifies how many minutes the Z-axis displays.

•

X/Y/Z Divisions: Specifies how many divisions each axis displays.

Rotate/Tilt Lock Position: If checked, you cannot change the graticule orientation by dragging the corners. Rotate/Tilt: Allows you to change the orientation of the graticule.

Cursor Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Waterfall Window The Waterfall Window displays the stored traces for a determined amount of time (trend time), in a two-dimensional stack. Time (in minutes) is displayed on the Y axis. The sweep speed is on the X axis. The traces can be trended in ascending or descending modes. The ascending mode, the most recent stored trace appears at the bottom of the graph and moves upward as new traces are added to the stack. The descending mode, the most recent stored trace appears at the top of the graph and move downward. The current time of day is displayed at the top (descending mode) or bottom (ascending mode) of the Y axis.

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Procedure Setup

Add Marker

Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window. Amplitude Markers

Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace. Window Setup

Please see Waterfall Trend Window Setup Global Window Setup

Please see Global Waterfall Window Setup Set Baseline

Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines

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Elite Operators Manual are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline. Copy

Copies the window view to the clipboard as a .bmp file where you can paste it into other Windows applications. Print Report

Select this option to specify a template and generate a report. When viewing modes, generating a report is based on all windows that are currently displayed. Only fields from the displayed windows are available for the report. The templates used for reports are "ed" so that you don’t need to select a template very often. Templates are "ed" by window type so if you print from one EP window, the same template will be used in another EP Window. Output to ASCII

Please see the Exporting Data section in the Starting/Running Procedure section.

Global Summary Window Setup Use the selections in this window to change common settings for all Summary windows at one time. This window is accessible from the right-click menu in the summary window while running a procedure, and is not accessible from the procedure setup screen.

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Show Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting. Events

Enter specific data for the event list you will use during the procedure.

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When enabled every fourth trial number will be displayed on the traces. All Trial Times

When enabled the trial times will be displayed in the far right-hand column. Channel Names

When enabled the channel names will be displayed in the top left of each trace window.

Waveforms Display Sweep

Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Channels Allows you to set the display gain for traces and turn them on or off. Show Cursors

Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

Global Waterfall Window Setup Use the selections in this window to change common settings for all Waterfall windows at one time. This window is accessible from the right-click menu in the summary window while running a procedure, and is not accessible from the procedure setup screen.

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Procedure Setup

Show Minutes Labels

Shows/Hides the axis minutes labels. Baseline Trace

Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window. Trace Name

Trace Name or Feature Label displays the name of the feature within the graph. Graticule

When checked, the graticule or grid is visible in the selected window. Division Units

When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

Waveforms The Waveforms section allows you to select the following parameters: •

Trace: Selects which trace is displayed.

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Sweep: Specifies at what sweep to display the traces. Note that this value does not affect the mode sweep setting. Select Default if you want the sweep to track the mode sweep setting.

•

Gain: Specifies the display gain for the trace.

•

Trend: Specifies how many minutes the Z-axis displays.

•

Order (time): The traces can be trended in ascending or descending mode. In ascending mode, the most recent stored trace appears at the bottom of the graph and moves upward as new traces are added to the stack. In descending mode, new traces appear at the top of the graph and move downward. The current time of day is displayed at the top (descending mode) or bottom (ascending mode) of the Y-axis.

Cursors Allows you to show/hide specific cursors. When checked, cursors are displayed (if available) on the traces. Select a cursor label option for the selected cursors: •

All Off: no cursors are displayed.

•

Crosshair Only: the crosshair (+) is displayed without a label

•

Label and Crosshair: both the label and crosshair are displayed

•

Value and Crosshair: the latency value and the crosshair are displayed, amplitude values are bracketed

•

Show on Baseline Only: the selected cursors are only displayed on the baseline traces.

Test Setup Tests define an Amplifier setup. When you switch tests, you are changing the amplifier setup and the available acquisition modes. While running a procedure, the may only run the modes that are active for the test being run. In procedure setup, the may only edit modes that are active for the test they are setting up.

Access Test Setup can be accessed from the top of the Procedure Setup page or from within the Channel Setup page. Within the Channel Setup, you may change the System Type from the Cascade Elite to the Cascade DSP-100 or the Cascade DSP 150, if need be.

Options Test Setup allows you to choose the active modes and default start view, and add or rename a test. Unchecking a mode makes it inactive and removes that mode from the DSP utilization checking. To add a test: 1. Click Add Test. 2. Name the test. 284

Procedure Setup 3. Copy channels and names if desired. 4. Click OK. 5. Specify Active Modes and Default Start View. 6. Click OK.

Other Setup System Type The DSP Speed drop-down box allows you to select the speed grade of the DSP processor. The resource utilization is computed based on the selected DSP speed. All new Cascades come with the DSP-150. Set the system type to Cascade Elite . Channels 17-32 and the 16-input pods are only available when the system type is set to Cascade Elite. The software automatically detects the system type when starting a new procedure.

Edit Groups Edit Events Add or edit event descriptions and priority. To use an event not listed, enter comments with the necessary event information during the procedure. Click OK. Timer Intervals Two timers allow modes to start on a specified interval. The interval can be defined in Procedure Setup or from the mode control view, and its value is stored in the Procedure Setup file. For example, if Timer1 interval is set to 60 seconds, and the Run All button is clicked, the modes run until their average count is reached. The trial will be stored, cursors placed, and the averager cleared. When 60 seconds has elapsed from when the last mode in the group has completed, the modes start again. If the Run All button is turned off, the timers are paused. A Clear Timer function is available in the Mode Control View. These selections are only available for EP modes.

Mode Groups You can group modes together and perform common functions such as start, stop, store and clear on several modes at once. When a mode group is setup, a Mode Control box for that group will be available in the Mode Control window. When you select start, stop, store or clear for a group, it is the same as performing the selected function on all of the modes in that group. Modes in groups continue to run according to their Run Mode type as set in the mode control box. Modes set to the Automatic run mode type will automatically store data,

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Elite Operators Manual clear the active traces and restart data acquisition when the group cycles. Modes set to the Manual run mode type will simply stop data acquisition when the group cycles. To setup a mode group, select the GrpSetup button in the Mode Controls window while running a procedure or choose the Edit Groups option in the Mode Groups menu in while in Procedure Setup.

Begin by clicking the Add Group button. Name the new group and select the modes to be included in the group by placing check marks next to the name of the mode in the Modes Included in Group area. Modes using the MEP mode type may not be added to groups.

The system can be setup to automatically change views when a group is started. Select a view from the list in the Default Start View drop down menu. The default option is for the system to not change views when a groups starts. 286

Procedure Setup

DSP Utilization Meter If the resource utilization meter is below 100%, the procedure can be used on any DSP. If the resource meter is 100% or greater for the DSP-100, but less than 100% for the DSP-150, the procedure can only be used on units equipped with the Cascade DSP-150 or the Cascade Elite. If you attempt to start a procedure which requires the Cascade DSP-150 on an instrument equipped with the Cascade DSP-100, the procedure will not be started, and an error message displays: "This procedure cannot be run. Please make sure that the DSP software is up-to-date and the procedure’s DSP utilization is less than 100%. The DSP utilization can be reduced by using fewer modes and channels, increasing sweep speeds, and turning off notch filters. To edit the procedure’s setup file, click OK." You can determine the DSP speed grade by selecting About Cascade from the Help menu. The first row in the device list displays the DSP information. It will display either "Cascade DSP-100" or "Cascade DSP-150." The DSP Utilization meter indicates whether the DSP (digital signal processor) is capable of performing the requested procedure. When the limit of 100% is reached, you must eliminate channels, change sweep speeds, or turn off notch filters before the procedure can be saved.

NOTE: The Cascade Elite uses the DSP type of the actual hardware that is plugged in when a procedure is started, regardless of the DSP type that was used when the file was created. The current hardware has no bearing on a setup file that is being created, and the setup dialog is unaware of the hardware, so the combo box cannot be changed to match the hardware. The default value is DSP 150. Whenever a DSP type is selected explicitly by the or implicitly by starting a procedure (which selects the hardware that is plugged in), the new value is stored in the registry and opens by default the next time the setup dialog is opened.

Mode Group Cycle The Cascade can be setup to automatically cycle from one mode group to another allowing you to spend more time monitoring and less time manually operating controls. For example, the Cascade can be set up to automatically cycle through a four-limb SEP group, a bilateral BAEP group and a train-of-four group while automatically displaying the view appropriate for the running group. When running in cycle mode, the system simply starts and stops a group. The run mode properties of the individual modes continue to be observed. 287

Elite Operators Manual Once programmed, starting fully automatic data acquisition using the Mode Group Cycle feature is as simple as clicking the Cycle button in the Mode Controls window. To set up the Mode Group Cycle, simply include a group in the cycle by checking the Include Group in Cycle check box. The Mode Group Cycle feature also allows you to customize the trigger for moving from one group to the next – the Cycle Condition. By default, the Cascade cycle condition is to advance to the next group when the average count for all modes in the group reaches completion. To change the cycle condition that advances the system from one group to the next, change the settings in drop-down boxes in the Group Cycle Properties area. See below for examples of different group cycle conditions.

To set the view to be displayed when the system switches to a group, select the name of the view in the Default Start View drop down box. The default setting, “No Change,” will leave the view unchanged during run time when the cycle moves from one group to the next. To change the order of the groups the system cycles through, click the Set Group Cycle Order button. In the Group Cycle Order Setup dialog, move a group up or down in the order by highlighting the group and selecting Move Up or Move Down respectively. Reset the order of the groups to the order the groups were created by selecting the Reset Order option.

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NerveGuard Procedure Setup In the EMG Mode Setup During Data Acquisition: Set EMG threshold levels - NerveGuard determines screw threshold by detecting activity in the triggered EMG channels based on the EMG thresholds set by the . Because the baseline amplitude of the EMG signal will vary from patient to patient, EMG thresholds should be adjusted relative to the baseline EMG for each patient prior to testing. EMG thresholds should be set just above the level of the baseline activity. The Threshold Setup option is available in the right-click menu of EMG mode. A visual indication of the threshold levels can be turned on using the Threshold Markers option in the right click menu of the EMG. A threshold setting too near to the baseline amplitude of the EMG will give false positive readings. A threshold setting too large will result in high thresholds. NOTE: The threshold setting numbers in the Setup EMG Threshold window are baseline to peak as opposed to peak to peak.

These tips will help you create a procedure setup file that will perform accurate, easy and swift pedicle screw threshold testing:

In the Procedure Setup File: 1. Click Channel Setup. 2. Assign Channels. Set Gains to a level appropriate for the amplitude of the baseline EMG activity. An amp gain setting of 50uV is ideal for quiet, lownoise EMG recordings. Click OK. (To change display gain, see step 8). 3. Add a Mode.

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Elite Operators Manual 4. In the Mode Settings Setup, choose Stimulator. a. Select a triggered EMG mode. b. Assign an appropriate electrical stimulator to the triggered EMG mode. (A stimulator that s current sensing is required: ES-5-20, ES-16 or ES-500). c. To avoid false positives from stimulus artifact: i.

Check Suppress Audio During Stim

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Set the Duration to 10 mSec

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Check Remove Stim Artifacts

5. In the Mode Settings Setup, choose NerveGuard.

a. Set the Intensity Criteria by selecting the colors used to indicate threshold ranges. Intensity Criteria determines the color displayed in the control box and sets the start and max stim levels.

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Max - sets the maximum stimulus intensity the NerveGuard software will deliver and the stimulus intensity at which NerveGuard will report NR (no response). This should be less than or equal to the maximum stimulus intensity set in the stim setup above.

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Yellow-Green Boundary – sets the upper limit of the yellow threshold boundary and the lower limit of the green threshold boundary.

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Red-Yellow Boundary – sets the upper limit of the red threshold boundary and the lower limit of the yellow threshold boundary.

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Start - sets the stimulus intensity at which NerveGuard starts. Starting Zoom State Determines what image the Spine Graphic will display. Options are Lumbosacral, Full Spine, Thoracic and Cervical.

Procedure Setup •

Intensity Increment Determines the increments (in milliamps, mA) that the program will use when it increases the stimulus intensity.

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Detection Mode Sets the program to run in “Screw Test”, “Continuous” or "Fixed" mode.

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Start and Max Sets the start and maximum intensities when running in Fixed stim mode.

b. Choose an appropriate NG Rep Rate (repetition rate) for the stimulator. Typically 8 Hz is utilized for NerveGuard pedicle screw stimulation. However, if you plan to leave your SEP modes running while using NerveGuard you should choose a repetition rate that matches the rate used by the SEP modes, such as 2.66, 2.79, 2.92, 3.63, or 4.13 Hz. c. that the maximum current setting in the stim setup is as high as, or higher, than the maximum intensity on the NerveGuard intensity criteria. 6. In the Mode Settings Setup, choose Trace Labels. a. Set every Field to None to turn off amplitude and peak latency trace labels to ensure the fastest threshold detection. If left on, these labels can slow down the program.

7. In the Mode Settings Setup, choose General. a. Set the Sweep of the Triggered EMG mode to the desired setting. A sweep speed of 8-10 msec/div is typical. 8. In the Views section, highlight Live: EMG and click Window Setup.

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that all channels are checked on (Hidden channels will cause false positive results). Click Use Display Gains and use the dial to change display gains.

NOTE: To access EMG Window Setup from a procedure, right-click a mode and click Window Setup.

Other Helpful Tips:

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Procedure Setup •

To hear free-running or triggered EMG audio and threshold tones, make sure the Mute box is un-checked at the top of the Mode Controls window and that the volume knob is adjusted to an appropriate level.

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Set the EMG amplitude threshold setting to an appropriate level. See Running NerveGuard for more information.

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If you will be using a high output stimulus (i.e., up to 100 mA maximum), you should limit the maximum intensity setting to 25 or 30 mA.

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The following settings, Wave/Beep on Threshold and Autocapture on Threshold, are active in NerveGuard and do not need to be turned on in order for NerveGuard to work properly. If you want to utilize these features outside of the NerveGuard program then they should be enabled.

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The Autostore on Threshold feature is not needed for NerveGuard to function. NerveGuard always stores one triggered EMG waveform for each threshold event. However, if you would like the triggered EMG traces collected during the free-run EMG in NerveGuard or in standard Cascade to be automatically stored upon threshold crossing, then you should enable this feature.

Stimulators Electrical Stimulators ES-IX Stimulator (Cascade PRO and Elite only) ES-IX stimulators are available for EP, MEP, TOF, and Triggered EMG modes. See Configuring the ES-IX for additional details about setting up the ES-IX. The following options are available in some or all mode types: •

Rep Rate: repetition rate in Hz. The number of times per second the stimulator will fire.

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Label: stimulator label, such as Lt Tibial

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Stim Number: stimulator number, such as Channel 1 to 16, and Low Output 1 or 2. Channels 9-16 and Low Output 2 are only available when two ES-IX stimulators are connected to the base unit.

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Pulse Width: range is 50 to 1000 usec. •

High Current Outputs – Each high current output can output from 0 to 100mA, 400 V maximum, with 0.5 mA resolution below 20 mA and 1 mA resolution above 20 mA.

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Low Current Maximum Output – The low current output is used to provide more precise adjustment of low level output currents than offered by the high current outputs. The low output of the ES-IX can be configured to four modes of operation. The amplitude resolution for each of the four modes is as follows:

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- 5 mA constant current (0.01 mA resolution)

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- 20 mA constant current (0.1 mA resolution)

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- 5 V constant voltage (0.01 V resolution)

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- 20 V constant voltage (0.1 V resolution)

Train Stimulation (Available only on the Cascade Elite. Modes with this option checked on will be disabled until the train stimulation is unchecked) o

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Train length (# of pulses): the length of the train in number of pulses. ISI (ms): the interstimulus interval between stim pulses. Measured in milliseconds.

Train (available only in the EMG mode type) o

Rep Rate: the frequency of the train in Hz.

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Duration: the duration of the train in seconds.

Multipulse Stimulation o

In addition to standard single-pulse reprate stimulation and EMG train stimulation, the ES-IX can perform repetitive multipulse stimulation

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When the Multipulse Stim box is checked, the multipulse options become available. You can create multipulse trains up to 10 pulses with interpulse intervals from 0.5 to 10 ms. These short trains will be repeated at the Rep

Procedure Setup Rate specified in the Rep Rate box on the left side of the ES-IX Stimulator Setup dialogue. Current and Voltage – The Cascade will display current delivered to the patient when using the ES-IX in any constant-current mode. The voltage delivered is displayed for the low output in constant-voltage mode. This assists the practitioner in assessing the quality of the stimulator to patient connections. Daisy Chain – Two ES-IX stimulators may be attached together to provide a total of 16 high current and 2 low current/voltage outputs. This both provides additional outputs and allows the placement of an ES-IX near the head and another near the feet of the patient.

Electrical Stim Splitters Electrical Stimulators are available for EP, MEP, TOF, and Triggered EMG modes. The following options are available in some or all mode types: •

Rep Rate: repetition rate in Hz. The number of times per second the stimulator will fire.

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Label: stimulator label, such as Lt Tibial

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Stim Number: stimulator number, such as 1 to 16, Low1, or Low2

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Pulse Width: range is 50 to 1000 usec.

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Max Intensity: range is 25 to 100 mA for high current outputs. Range is 0-5, 0-10, or 0-20 mA for low current outputs depending on the type of splitter box being used.

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Train Stimulation (Available only on the Cascade Elite. Modes with this option checked on will be disabled until the train stimulation is unchecked) o o

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Train length (# of pulses): the length of the train in number of pulses. ISI (ms): the interstimulus interval between stim pulses. Measured in milliseconds.

Train (available only in the EMG mode type) o

Rep Rate: the frequency of the train in Hz.

o

Duration: the duration of the train in seconds.

TCS Stimulators The TCS stimulators are constant voltage electrical stimulators intended for the performance of Motor Evoked Potential studies. Connection to the Cascade is made via an auxiliary cable connected from one of the auxiliary ports (Aux 1, 2 or 3) on the back of the Cascade to the TCS device. Operation of the TCS is controlled through the Cascade system software.

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Elite Operators Manual Do not connect TCS output leads to anywhere other than the head. This eliminates the potential for transthoracic currents in any failure mode.

Single-output Transcranial Stimulators (TCS-1/TCS-1000) The TCS-1/TCS-1000 connect to the patient via one stimulus output pair consisting of one red and one black DIN electrode jack. The “normal” polarity setting delivers stimuli with the red output as anode (+) and the black output as cathode (-). The “reverse” polarity setting delivers stimuli with the red output as cathode (-) and the black output as anode (+). TCS-1

The following stimulus options are available for the TCS-1 stimulator: • Stimulus polarity: Normal or Reverse • Train Length: The TCS-1 s multi-pulse train stimulus and single pulse stimulus. The train length setting specifies the number of stimulus pulses delivered in each train; the range is 1 to 9. • Inter Stimulus Interval (ISI): The time from the start of one stimulus pulse to the start of the next stimulus pulse within a train. The range is variable from 1.0 to 9.9 milliseconds (ms). • Maximum Intensity: 800 volts; variable in 2 volt increments. The maximum intensity may be set independently for each mode in the procedure setup file that uses the TCS-1. • Repetition Rate: No repetition rate is needed or available for MEP mode types. The repetition rate may be set from 0.5 Hz to 1.0 Hz when using the TCS-1 with EP and EMG mode types. • Stimulus Pulse Width: 50µs (0.05 ms) fixed. • Double-Train Stimulation: Delivers two trains of stimulation with a -selected inter-train interval. The built in safety limits on the TCS-1 limit the stimulus parameters to combinations of train length and intensity described in the chart below.

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All of the stimulus settings (except Pulse Width and double-train) can be changed within the Mode Controls window.

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TCS-1000

The following stimulus options are available for the TCS-1000 stimulator: •

Stimulus polarity: Normal or Reverse

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Train Length: The TCS-1000 s multi-pulse train stimulus and single pulse stimulus. The train length setting specifies the number of stimulus pulses delivered in each train; the range is 1 to 9. There is no train length/voltage limitation on the TCS-1000.

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Inter Stimulus Interval (ISI): The time from the start of one stimulus pulse to the start of the next stimulus pulse within a train. The range is variable from 1.0 to 9.9 milliseconds (ms).

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Maximum Intensity: 1000 volts; variable in 2 volt increments. The maximum intensity may be set independently for each mode in the procedure setup file that uses the TCS-1000.

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Repetition Rate: No repetition rate is needed or available for MEP mode types.

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Stimulus Pulse Width: 50µs (0.05 ms) & 75µs (0.075ms).

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Double-Train Stimulation: Delivers two trains of stimulation with a selected inter-train interval.

Multiple-output Transcranial Stimulator (TCS-4) The TCS-4 connects to the patient via up to four stimulus output pairs, each consisting of one red and one black DIN electrode jack. The “normal” polarity setting delivers stimuli with the red output of the active channel as anode (+) and the black output of the active channel as cathode (-). The “reverse” polarity setting delivers stimuli with the red output as cathode (-) and the black output as anode (+). The anode jack of the active channel is designated by a solid lit LED. Always connect channel 1 of the TCS-4. This channel has the patient static equalization circuit for the stimulator. Failure to connect the patient to the anode jack on channel 1 of the TCS-4 may result in electrostatic discharge just prior to the stimulation pulse, which may cause excessive stimulation artifact. TCS-4 Options The stimulus options for the TCS-4 stimulator are the same as for the TSC-1000, but with four -selectable channels. While the TCS-4 provides the ability to connect four stimulating channels to the patient, only one output channel can be active at any given point in time. For the TCS-4, all of the stimulus settings, including the output channel number (except Pulse Width and double-train) can be changed within the Mode Controls window. 298

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TCS-4 LEDs There are eight multi-purpose LEDs on the side faceplate of the TCS-4, one for each output jack.

There are four potential states for the LEDs, each of which is detailed here.: 1. All LEDS off: no active TCS-4 channel. If an MEP mode is not active, none of the channel LEDs will be on, even if the TCS-4 is connected to the base and the power LED of the TCS-4 is on. 2. Each LED blinks once in sequence from left to right as the TCS-4 conducts a brief self-test. This self-test is initiated automatically each time an MEP mode becomes active after a period of inactivity (e.g., when a Test containing an MEP mode is selected or when coming out of Mode or Channel setup menus). 3. A single solid LED indicates the anode of the active output channel. 4. Indicators for an Anode/Cathode pair blink three times rapidly when this channel is triggered.

Auditory Stimulator Auditory Clicks are available for EP modes. The click stimulus is generated using a fixed pulse width of 100 microseconds. The following options are available: Polarity: The polarity may be set for rarefaction, condensation, or alternating phase clicks. Intensity Range: -10 to 100 DB NHL. Side: Select Left, Right, or Both. 299

Elite Operators Manual White Noise Masking: Noise masking may be turned on and off by the operator. Only differential mode masking is implemented in auditory protocols. Differential masking is set for the ear contralateral to the stimulated ear. Masking Level: The masking level is determined by subtracting the differential masking level from the stimulus level. The range is 0 to 60 dB. Start Intensity: The range is -10 to 100 dB; the default is 80. Inserts: When this option is selected, 1 ms is subtracted from cursor latency values throughout the system. Only the intensity is available in the Mode Control Dialog. In the popup Mode Setup dialog the RepRate, Polarity, Masking on/off, and Mask intensity is available. If two or more modes are running (interleaving) with clicks in different sides, masking is turned off.

Visual Stimulators Two types of visual stimulators are available for EP modes only. Goggles

Goggles have LED’s (lights) can flash on the right side, left side, or both sides at once. You can select Left, Right, or the Both option for this stimulator. LED Checks

This is a 3-inch, hand-held, red/black, reversible checkerboard pattern. Video Checks

This is for use with a black and white video monitor. Check size is selectable. Must be a CRT monitor.

Paired Stimuli Paired stimuli are available for EP, EMG and MEP modes. The first stimulation primes a muscle for motor cortex stimulation. In MEPs, paired stimuli allow TceMEP Peripheral Facilitation, and are used to perform “Andersson” and “Tetanic” peripheral stimulations. Paired Stimuli cannot be used with the Cascade 16 channel base. The DSP (digitial signal processor) does not it.

Set Up Paired Stimuli 1. From an active patient file, open Edit Procedure Setup or Current Procedure Setup.

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Procedure Setup 2. In the Mode Settings, Stimulator section, choose Paired Stimuli from the Stim Type drop-down list.

3. Click on the Setup Stim button. The Paired Stimuli Setup will open. With the Peripheral Facilitation selected, the Rep Rate and Stim Types are static. Paired Stimuli defaults to Electrical and TCS-1 stim types.

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Uncheck the Peripheral Facilitation box to change the Stim Types using the drop-

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Procedure Setup down lists.

4. Click on the Setup Stim button for Stim 1 to access the stimulator setup window. See examples for stim types below.

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5. Click the OK button to save and exit stim setup. 6. Repeat steps 4 & 5 for Stim 2. 7. Click the OK button to save and exit Paired Stimuli Setup. 8. In the toolbar, open the File menu and select Save. 9. Click the OK button to save and exit Edit Procedure Setup. 10. Proceed with the recording.

Use Paired Stimuli in Mode Type The stims will appear in the Mode Controls window. The dual intensity knobs, pulse number, pulse width, ISI and ITI controls will be set according to the options programmed during stim setup.

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For the fields in the Mode Controls and the options in the stim setup dialogs, use the following ranges: Frequency control: 50 - 1000 Hz Estim ISI: 2 – 15 msec Estim Pulse Count: 1 - 10 TCS-1 and CV-2 ISI: 1 - 9.9 msec TCS-1 and CV-2 Pulse Count: 1 - 9 Number of seconds: 1 – 20 msec ITI control: 1 – 100 msec Pulse width: 50 - 1000 msec Some combinations may result in later stim pulses that do not deliver full stimulation. A notification will automatically pop up during setup. If overridden, and if stim pulses are not at full intensity, this yellow icon will appear in the Mode Control during the procedure.

Cascade EEG and EEG Analysis Example EEG Analysis Windows

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CSA with 97% Spectral Edge This example shows 8 channels of EEG displayed in a CSA format. The trend time is 5 minutes, the frequency range is 1.5 to 30 Hz. The Spectral Edge is plotted as a yellow line.

DSA, rainbow color scale: 8 channel DSA display using the rainbow color scale. Trend time is 10 minutes, maximum DSA power scale is 10 pW. Frequency range is 1.0 to 20.0 Hz. Note the increased Alpha frequencies in the temporal and parietal-occipital channels over the last 4 minutes.

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DSA with Symmetry Symmetry is shown down the middle of the display. The absolute difference between each channel on the Left and its corresponding channel on the Right is calculated for each frequency bin (Left minus Right). The Symmetry trend is always shown with a Red-Black-Blue color scale. Red indicates that the channel on the Left has more power at the corresponding frequency than the channel on the Right. Blue would indicate that the channel on the Right has more power at that frequency than the channel on the Left. In this example, the P3-O1 channel has more power in the alpha frequencies than the P4O2 channel.

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Z-Score This display shows the Zscore values for 8 channels. The Zscore is a comparison of the current EEG epochs to the most recent Baseline. Red colors indicate frequencies that are increased compared to the baseline. Blue colors indicate frequencies that have decreased compared to the baseline. A Z score of 1 corresponds to a difference of 1 standard deviation between the current epoch and the most recent Baseline. In this example, Alpha and Beta frequencies have shown an increase over the last 4 minutes in the temporal and parietal-occipital channels.

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Trend This display shows a 5 minute trend of Relative Alpha Power for each channel. The trend shows an increase in alpha power in the temporal and parietal-occipital channels.

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EEG Windows EEG Windows: When an EEG mode is added to a procedure setup, the View window list is automatically updated to include the Live EEG window and the EEG Analysis window. Live EEG Window

This window displays the Live EEG data in a sweeping fashion from left to right across the window. When this window is active, the EEG toolbar is displayed at the top of the screen. The toolbar has controls for changing the Display Gain and the Sweep Speed of the window.

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Procedure Setup Display Gain units (microvolts per vertical division) Sweep Speed units (milliseconds per horizontal division)

Live EEG Right-click menu

Run – starts and stops the EEG traces. Window Setup - see below Trace Labels – turns Off/On the channel labels, i.e., P4-O2. Setup – displays the EEG mode setup window (see below). Copy – copy the window to the clipboard so it can be pasted into other Windows applications. Print – displays the Print Report menu. Live EEG Setup menu

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Controls in this window are used to toggle the trace labels, graticule or division units Off or On. The sweep speed can be adjusted as well as the individual channel display gain settings.

EEG Analysis Window The EEG Analysis window displays analyzed EEG data in several formats. When the Live EEG mode is running the EEG data is sampled every 10 seconds. An FFT (fast fourier transform) is performed on the sampled epoch and the resulting frequency and power information can be displayed in a variety of formats. The Setup menu is used to determine the type of display format. NOTE: You can make a copy of the Analysis window and have one window setup to display DSA data and have the other window setup to display CSA data simultaneously in the same View.

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Procedure Setup EEG Analysis Setup Menu

EEG Analysis Setup menu General and Scale Settings:

View – select CSA, DSA, Symmetry or Trend for the data presentation type. Frequency Range (Hz) – select the low and high frequency limits for the horizontal axis. The lowest setting is 1.0 Hz, the highest setting is 30 Hz. Trend Time – determines the amount of data that is displayed in the vertical axis, i.e., the last 10 minutes. Channel Labels – turns the channel labels On or Off in the window. Spectral Edge – turns the spectral edge indicator On or Off and selects the spectral edge frequency value (50, 90, 95, 97 or 99 %). Spectral edge is always determined for the total frequency band of 1 – 30 Hz. Reject – turns the artifact reject algorithm On or Off and selects the threshold level for the reject in picowatts (pW). The reject is based on the total power contained in the sampled epoch. If the total power in the epoch exceeds the reject level then the data for the epoch is not displayed and is replaced by a small “yellow” dash for that point in time in the window. DSA Smoothing – only functions when the DSA view has been selected. DTAB (DSA) – only available when the DSA view has been selected and DSA smoothing is Off. This setting causes the DSA trends to be

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Elite Operators Manual displayed in discrete frequency bands of Delta (1-3.5), Theta (3.5-7.5), Alpha (7.5-12.5), Beta (12.5-25), and High Beta (25-30) Hz. Voltage – changes the analysis window to display voltage (microvolts). Power – changes the analysis window to display power (pW or microvolts squared). Power is the most common setting to use for CSA and DSA displays. Zscore – changes the analysis to display the difference (in z-score units) between the trended data and the most recently selected baseline. Most commonly used with DSA displays. A Z score of 1 corresponds to a difference of 1 standard deviation. As Recorded – when this box is checked, the display will be shown exactly as it was setup during the recording. When this box is unchecked, you can change the setup choices and review the data differently than it was originally recorded. CSA Scale – used to increase or decrease the height of the CSA plots. DSA Max Voltage – used to set the top level of the color scale when displaying DSA Voltage trends. DSA Max Power – used to set the top level of the color scale when displaying DSA power trends. Channel Settings:

Use the check boxes to add or remove channels from the display. When the Symmetry View is selected you can specify the channels that are to be compared. Simply click & drag the appropriate channel label to the desired location to create the pairs that will be analyzed for symmetry. To remove a channel from a pair, drag the channel label to the trash bin. Note: Symmetry is a trend showing the absolute difference between the channel on the left vs. the channel on the right. Trend Settings:

Trend - when the Trend View is selected these controls can be used to select the type of data to be trended. Select from Total Power, Absolute Power, or Relative Power. When either Absolute or Relative power are selected the frequency band can also be selected (Delta, Theta, Alpha, Beta, Delta+Theta, or Alpha+Beta). Range (pW) – sets the maximum limit for the horizontal (x-axis) of the trend displays. DSA Colors:

When the DSA View is selected these controls can be used to select the color scale. Z Score Colors:

When the DSA View + Zscore item is selected these controls can be used to select the Zscore color scale. 314

Procedure Setup EEG Analysis Right click menu:

DSA – toggles the analysis window to show DSA (Density Spectral Array) trends. CSA – toggles the analysis window to show CSA (Compressed Spectral Array) trends. Symmetry – toggles the analysis window to show DSA trends with symmetry trends plotted down the middle. Trend – toggles the analysis window to display power trends. Set Baseline – used to enter an EEG Baseline event. When selected a comment box will appear that allows a short comment to be tagged to the baseline event.

Setup – displays the EEG Analysis setup window. As Recorded – when checked, sets the display to the same settings that were used during the recording. Copy – copy the window to the clipboard so it can be pasted into other Windows applications. Print – displays the Print Report menu.

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Remote Monitoring Introduction What is Remote Monitoring? Remote Monitoring is an optional program feature that allows a remote Reader station to simultaneously view the same data that is being acquired and displayed on the Cascade in the operating room. The remote Reader can be located within the same building, it can be located across town, or it can be located in another state. One Reader station can remotely view up to three different Cascades at one time. Remote monitoring is a server/client application and uses the DCOM (Distributed COM) architecture that is built-in to the Windows(TM) operating system. The Cascade acts as a server while the Reader acts as a client and periodically requests updated information from the Cascade. Cascade program features that are ed on the remote Reader are described below, as well as a few that are not. The next section briefly describes some of the possible connection scenarios that can be used to accomplish remote monitoring.

What can you do on the Remote Reader? With the Cascade’s built-in Remote Monitoring, the Remote Reader can do the following: 1. Change Views independent of the acquisition Cascade. For example, the Reader can look at trending windows while the technologist in the OR (Cascade) is viewing EP Average windows. 2. Change trace display gain, trend counts, resize windows, etc. without affecting the acquisition Cascade or the original data. 3. Review the procedure being monitored. The Reader can click anywhere along the timeline and reset the display to show the data for that point of the procedure. 4. Chat. A chat box can be used to send messages back and forth between the Reader and the Cascade. This can be done without interrupting data acquisition. 5. Generate reports. The Reader has full report generation capability. 6. View Live EMG. With a fast connection, (i.e., across a local area network), the EMG is essentially ‘real time” on the Reader. With a slow connection, (i.e., modem), EMG cannot be viewed on the Reader. 7. View Live Video. With a fast connection, (i.e., across a network), the Video is sent about one frame every three seconds. With a slow connection, (i.e., modem), the Video is only sent when the Reader requests a new frame.

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Elite Operators Manual 8. Connect to more than one Cascade. The Reader can monitor more than one Cascade at a time, depending on the connection speed and system resources. Three is the maximum number of Cascades that can be monitored on one Reader. 9. Change the display properties. The Reader can change window and trace colors independently without affecting the acquisition Cascade or the original data. 10. Review previously recorded cases. The Reader systems may also review procedures that have already been recorded by opening that file in the review mode. The file can be copied to the local hard drive of the Reader system or viewed over a LAN. Cascade files with a Read Only attribute, such as files on a CD, cannot be read from either the Cascade system or the Reader system. They must be copied from the CD back to the hard drive and have the Read Only attribute removed.

What can't you do on the Remote Reader? Some things the Remote Reader cannot do: 1. The Reader cannot take control the Cascade. For example the Reader cannot make the Cascade start or stop data acquisition. 2. The Reader cannot make changes to original acquisition parameters, (i.e., filters, or test montages). 3. The Reader cannot move cursors on the traces. However, the Reader can use the time and amplitude markers independent from the Cascade. 4. The Reader cannot edit or change the patient information. 5. The Reader cannot view Live EMG on a slow connection, (i.e., 56k modem connection). 6. No Audio. The Reader cannot listen to EMG activity regardless of the connection speed.

Minimum Computer Requirements* The computer used to run the Cadwell Cascade system is an integral part of the Cascade neuromonitoring system. For optimum performance, use a computer that meets the following criteria. Standard computers purchased from Cadwell will meet the listed requirements. • US and Canada regulatory requirements. Computer and information technology equipment connected to the Cascade must be third-party certified to UL1950 or IEC950. • European Union regulatory requirements. Computer and information technology equipment connected to the Cascade must be third-party certified to EN60950. • Performance requirements. These requirements represent the minimum computer performance requirements necessary to run the Cascade. Your Cascade

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Remote Monitoring equipment will run better when used with a computer with a faster processor and more RAM than listed here: Operating System Windows 7. Note: Cascade v2.7 has not been tested on Windows Vista or Windows Server. Processor 2.7 GHz Dual Core, I7 processor Hard Disk Drive 80 Gigabytes Memory (DRAM) 4 GB Archive Device Any Windows ed device Graphics 1600 x 900 (1200); 64 MB (recommended); 1024 x 768 resolution; 16 MB, 32-bit color depth (ed, but not recommended), ATI Graphics preferred Network 10 Base-T Ethernet card; Second card (10/100 Base-T) required for remote monitoring Cascade remote connections will work on Windows 7 Professional. Cascade systems use proprietary software to encrypt the data between the two computers for security. Windows 7 Professional is the preferred operating system for Cadwell Cascade systems. Windows 7 home edition does not have all the networking components automatically installed. Cadwell tests Cascade software on Windows 7s Professional and recommends using that operating system for Cascade systems. *Excerpted from 300014-000 Minimum Computer Specifications and Requirements for Cadwell Instruments

Connection Scenarios Remote Monitoring Connection Diagrams The following diagrams display connection scenarios known to work for Cascade Remote Monitoring. Cascade’s built-in remote monitoring feature was designed to be used on a Local Area Network (LAN). On a LAN both the Cascade and Remote Reader systems are part of the same network and can communicate with each other using their unique network IP address or computer name. A very simple LAN can be created using a direct Dial-Up connection between the two systems. A Virtual Private Network (VPN) client can be used to connect one system, located outside the network, to the network the other device is located on, thereby making it seem that both systems are actually on the same network. The VPN client creates a secure ‘tunnel’ through the Internet and the firewall/router at the network location, thereby allowing the remote system to access the IP addresses of other computers on the network. For obvious security reasons, a router/firewall typically hides the IP addresses of network computers from the internet. Systems that are outside the LAN and do not

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Elite Operators Manual use a VPN client to that network may have trouble making a remote monitoring connection. Once the Cascade and Remote Reader are part of the same network, remote monitoring can be initiated. There are two ways to initiate a remote monitoring session. •

Remote Reader connects to the Cascade – on the Remote Reader system start the Cascade program and select “Connect to Cascade (server)” from the Remote pull-down menu. Enter the Cascade’s IP address or computer name and click OK.

•

Cascade connects to the Remote Reader – this option requires software version 2.5 or higher. On the Cascade, start a procedure and then select “Connect to Reader (client)” from the Remote pull-down menu. Enter the Reader’s IP Address or computer name and click OK. Using this connection option requires additional DCOM configuration settings on the Remote Reader.

Software firewalls, internet security programs, or virus protection software can also block or interfere with Cascade Remote Monitoring connections. Please review the Cascade Remote Monitoring document, in the Documents folder on the Cascade installation CD, for configuration details.

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Peer to Peer on a LAN Method #3: Network (Peer To Peer on existing LAN)

The Cascade and Reader can be connected in their own peer-to-peer network (using a network cables and a hub connected directly between the two computers) or, they can each to a local area network within the same building. This method requires that the Cascade have (2) network cards installed. Once the connections are established on the LAN the of the Cascade must determine it’s unique connection IP address and provide this to the Reader. This is done using a Windows utility called WINIPCFG for Windows 98 and IPCONFIG for Windows XP. The Reader can then connect to the Cascade by entering this IP address in the Connect To Server menu. On a LAN the Reader can often use the computer name of the Cascade system as well.

VPN into LAN 322

Remote Monitoring Method #4 Via Internet using Virtual Private Networking (VPN)

The Cascade and Reader communicate over the Internet using a secure, encrypted, communication protocol. This is established with the VPN (Virtual Private Networking) connection. The Reader computer needs to have a VPN protocol installed and configured, the type of protocol usually depends on the type of “firewall/router” that is being used at the Cascade’s location. The VPN Reader software is provided by the for the LAN you are trying to access. The Reader makes a connection to an Internet Service Provider (using a standard modem, or cable/DSL modem), then, a VPN connection is established with the “firewall/router” where the Cascade is located. Once the connection is established the Reader can initiate a remote monitoring session with the Cascade.

Third Party Software Method #5 Third Party Remote Software

Other programs such as PC Anywhere, NetMeeting, VNC, or Windows Messenger can also be utilized. There are several disadvantages when using third party software compared to Cadwell’s built-in solution, most notably, 1) the remote Reader PC is restricted to only one view of the data, 2) the remote Reader has no ability to “look back” through the record, and 3) the remote Reader PC has no ability to generate reports. 4) Cadwell does not test third party remote connection software packages for reliability and stability. It is recommended to use the Cascade built in remote monitoring software.

Setup Instructions Setup for Remote Reader 1. Open the Network Connections window. 323

Elite Operators Manual 2. Double click on the Create a new connection task located at the upper left portion of the window. The Create New Connection Wizard will be started. Click the Next button. 3. For the Network Connection Type, select Connect to the network at my workplace. Click Next. 4. For the Network Connection, select Dial-up Connection. Click Next. 5. Enter a name for this dial-up connection. The name of the Cascade you are calling (i.e., Cascade1) is recommended. After typing the name, click Next. 6. Enter the phone number for the Cascade you will be calling. If you need a “1” for long distance or a “9” for an outside line, enter these as well. Click Next. 7. On the Completion window, check the box labeled “Add a shortcut to this connection to my desktop”. Click Finish. The Dial-up Connection window will open up automatically, just Cancel it for now. When you are ready to make a connection, make sure both the Cascade and remote Reader systems have the phone line plugged into the systems modem. Double click on the connection shortcut on the remote Reader system desktop. Click on the Connect button. Once the connection is established you can open the Cascade program on the remote Reader system and open the case through the Remote pull down menu. See Starting a Remote Monitoring Session for more details.

Peer to Peer on a LAN setup Cascade 2nd Network Card & Reader Network Card A Peer to Peer network is two or more computers connected together configured to share resources and files. LAN, or Local Area Network is a several computers connected together and configured to share resources and files. The rule of thumb is to set IP addresses up in the same format on all systems in your network. If the remote Reader system is configured to “Obtain and IP address automatically”, then the Cascade system should be configured the same way. If an IP address is specified on one system then the other systems should use similar IP addresses. Large facilities use a DH server to automatically assign a computer’s IP addresses on their network. Cascade 2nd Network Card & Reader Network Card

The Cascade system uses one network card to communicate with the Cascade hardware. That network card is dedicated to this task. It is configured at Cadwell before the system is shipped. For configuration instructions on this network card reference the “Network Card Setup in Windows XP.doc“ document on the Cascade installation CD in the Documents folder. The second network card on the Cascade system, and the network card on the remote Reader system are configured for a LAN and/or High Speed Internet connection. The remote Reader will connect to the Cascade either through a LAN or an IP address on the Internet. On a Cascade laptop computer this network card is usually a PCMCIA or PC Express card that is inserted into the side of the laptop. In a small peer-to-peer network a 324

Remote Monitoring specific IP Address needs to be assigned to the card. This address can either be manually assigned or dynamically assigned by using a DH (Dynamic Host Configuration Protocol). A DH server dynamically assigns the IP address to the card when the computer boots and is connected to the network. The DH server assigned network addresses can change over time. Follow the steps on the next page to manually assign an IP address to a network card. 1. Start>Control >Network Connections to open the Network Connections window. Find the icon that corresponds to network card #2 on the Cascade system.

2. Right-click on the Local Area Connection icon and select Properties.

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3. Make sure all of the check boxes are checked. Highlight the Internet Protocol (T/IP) and then click the Properties button. 4. Select Use the following IP address. On the Cascade system for the IP address

enter 192.168.0.1 and 192.168.0.23 for the remote Reader system as an example, click anywhere within the Subnet mask area and it will fill in automatically with 255.255.255.0. For systems using DH the “Obtain an IP address automatically” would be used.

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5. When done entering the IP address click on the Advanced button. 6. Click on the WINS tab. In the NetBIOS setting area, select the Default option.

7. Click OK, click OK, click OK . Close the Network Connections window. Internet Protocol (T/IP) properties needs to be configured on both the remote Reader system and the Cascade system. Connecting the remote Reader system to the Cascade

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Elite Operators Manual works best if they are on the same network. For this example the IP address the Cascade systems IP address is 192.168.0.1 and the remote Reader system would be set to 192.168.0.2. With a subnet mask of 255.255.255.0 on both systems. In a simple networking scheme the subnet numbers should match on all systems. Use the subnet mask, 255.255.255.0. The last digit place (octet) in the IP address needs to be different for each system. That is the number on the far right in the IP address. You can use any numbers between 1-254. The other three octets should be identical on all systems. Then both systems will have unique IP address on the same network. Both system should be of the same Workgroup and each system needs to have a unique computer name. Either the computer name or its IP address can be used to connect to the Cascade or the remote Reader systems. The Browse button in the connection window looks for the computer name on the network. If the IP address of the system you are making a Cascade connection to is known, it can be used instead of the computer name to establish a remote connection.

DCOM Configuration Running on the Windows XP operating system requires specific settings to allow the Cascade and the Remote Reader system to have different names and s. Follow these instructions to setup a Cascade system running Windows XP for remote monitoring. Note there are extra settings for system running Windows XP service pack 2. The same settings apply to remote Reader systems if you are using the Connect to Reader option. Cascade uses distributed com to share its application. DCOM does not SSL firewalls.

Option A: 1. Click on the start button and select Run. 2. Type in C:\Cadwell\Cascade\Cascade DCOM Settings.reg 3. Click OK. 4. Click on the start button and select Run. 5. Type in C:\Cadwell\Cascade\DCOM My Computer.reg 6. Click OK. These files are ran automatically during the Cascade software installation with Cascade version 2.1.85 and later. Some times the settings need to be configured manually to correct a DCOM error. In extreme cases you may need to go into the C:\Cadwell\Cascade folder, double click on a file called "regsvr.reg". Click Yes then click OK. Then right click on the file "Cascade.exe" and select Un COM Server. Then right click again on Cascade.exe" and select COM Server. The last step would be to follow the steps in Option B to manually configure the DCOM settings. 328

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Option B: 1. From the Start menu, click Control . 2. If the display is set to Category View, click “Switch to Classic View.” 3. In the Control open “istrative Tools.” 4. Open “Component Services.” 5. Double-click on “Component Services." It may take the system a moment to respond. 6. Double-click on the "Computers" folder in the left window pane. 7. Right-click on the "My Computer" icon in the Component Services window and select "Properties."

8. Click on the "Default Properties" tab. a. Check the box to “Enable Distributed COM on this computer.” b. Set the “Default Authentication Level” to None. c. Set the “Default Impersonation Level” to Identify. Note: Normally no changes are required on this tab. Some PCs will have a different value for Default levels, which may interfere with report generation.

9. Click on the COM Security tab. a. Click on the "Edit Limits" button under Access Permissions. b. Select the listing for Anonymous Logon. c. Check the Allow box for the "Local Access" and the "Remote Access" boxes. d. Select the listing for “Everyone”. e. Check the Allow box for the “Local Access” and the “Remote Access” boxes. f.

Click OK.

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Elite Operators Manual Note: If the selection of Everyone and/or Anonymous is missing from the top add that listing. (To add a or s to one of the permissions windows click the Add button. Then click the Advanced button. Next click the Find Now button. Locate and select the you want to add in the list that appears below. Click the OK button. If you need to add another to the list click Advanced then Find Now again and select them from the list and click OK. After selecting the (s) click OK again to return to the permissions section.) Check all Allow boxes for all s in this window.

10. On Server Pack 2 Systems only, click the "Edit Default" button in the Access Permissions section. a. Select the listing for "Self.” b. Check the "Allow" box for the “Local Access.” c. Check the "Allow" box for the “Remote Access.” d. Select the listing for "System." e. Check the "Allow" box for the “Local Access.” f.

Check the "Allow" box for the “Remote Access.”

g. Click OK. Note: If the selection of Self and/or System is missing from the top add that listing. (To add a or s to one of the permissions windows click the Add button. Then click the Advanced button. Next click the Find Now button. Locate and select the you want to add in the list that appears below. Click the OK button. If you need to add another to the list click Advanced then Find Now again and select them from the list and click OK. After selecting the (s) click OK again to return to the permissions section.) Check all Allow boxes for all s in this window.

11. Under Launch and Activation Permissions, click the "Edit Limits" button . a. Select the listing for “Everyone.” b. Check the "Allow" boxes for the “Local Launch”, “Remote Launch”, “Local Activation” and “Remote Activation." c. Click OK. Note: If the selection of Self and/or System is missing from the top add that listing. (To add a or s to one of the permissions windows click the Add button. Then click the Advanced button. Next click the Find Now button. Locate and select the you want to add in the list that appears below. Click the OK button. If you need to add another to the list click Advanced then Find Now again and select them from the list and click OK. After selecting the (s) click OK again to return to the permissions section.) Check all Allow boxes for all s in this window.

12. Under Launch and Activation Permissions, click the "Edit Defaults" button . a. Select each in the list one at a time. b. Check the "Allow" box for the “Local Launch”, “Remote Launch”, “Local Activation” and “Remote Activation." c. Click OK. Note: If the selection of , Interactive and/or System is missing from the top add that listing. (To add a or s to one of the permissions windows click the Add button. Then click the Advanced button. Next click the Find Now button. Locate and select the you want to add in the list that appears below. Click the OK button. If you need to add another to the list click Advanced then Find Now again and select them from the list and click OK. After selecting the (s) click OK again to return to the permissions section.) Check all Allow boxes for all s in this window.

13. Click Apply and OK to close the My Computer Properties window. Note: To apply the changes made in Computer Properties, you must reboot the computer.

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Remote Monitoring 14. In the Component Services window, click on “My Computer." 15. Double-click on the “DCOM Config” folder. 16. Right-click on the “Cascade” icon and select “Properties."

17. In the General tab set the “Authentication Level” to None. 18. Open the Location tab and select “Run application on this computer.” 19. Open the Security tab set the “Launch and Activation Permissions” to Customize, and then click the Edit button. a. Select the listing for “Everyone”. b. Check the Allow boxes for “Local Launch”, “Remote Launch”, “Local Activation” and “Remote Activation.” c. Select the listing for each in the list, and repeat step 19.b. For systems running Windows XP service pack 2 add the of Anonymous Logon, check all the allow boxes and click OK. If the selection of Everyone, Interactive, Anonymous and/or System is missing from the top add that listing. (To add a or s to one of the permissions windows click the Add button. Then click the Advanced button. Next click the Find Now button. Locate and select the you want to add in the list that appears below. Click the OK button. If you need to add another to the list click Advanced then Find Now again and select them from the list and click OK. After selecting the (s) click OK again to return to the permissions section.) Check all Allow boxes for all s in this window.

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Elite Operators Manual d. Set the “Access Permissions” to “Use Default.” e. Set the “Configuration Permissions” to “Customize.” 20. Click on the “Identity” tab. a. Select “The interactive .” b. Click “Apply.” c. Click “OK.” 21. Close the Component Services window. Changes made to the DCOM settings for Cascade properties take effect when the Cascade application is restarted.

VPN into LAN setup A VPN (Virtual Privet Network) connection into a LAN is very similar to the Peer to Peer connection. A VPN client, which is a software package provide by the facility you are trying to access, allows you to logon to that facility's LAN and get through their Internet firewall. The Cascade system or the remote Reader system can use a modem to dial into the Internet, through an ISP (Internet Service Provider), and access the facilities LAN. Or use DSL or cable modem to connect to the Internet and access the facilities LAN. An Internet connection from another facilities LAN, such as a T1 or T3 line can also be used. Modem connections are slow and limit the data being sent. They should only be used as a last resort.

VPN to VPN setup In a VPN to VPN connection both the Cascade system and the remote Reader system are using a VPN client to connect to a LAN. Once both systems are connected to the LAN the systems can see each other and the Cascade procedure can be viewed remotely. Some additional rules may need to be added to the facility firewall software. If the two VPN client systems cannot ping each other when connected to the LAN, add a rule to allow any and all VPN to VPN communication.

Third Party Software setup Third party software, such as PC Anywhere, VNC, and Microsoft Net Meeting can be used to allow one computer see another computer using the same roadways to connect two systems as used by the built in Cascade remote monitoring software. The phone lines, the Internet and/or a LAN connection. The same network IP address and/or modem connection configuration apply to these software packages as well. Each third party software package will require configuration within the software program. Follow the manufactures instructions. Each relies on the computer name and/or IP address to connect the two systems. The software will need to be loaded on each system. Be careful to configure the Cascade system so that Remote Reader systems cannot take control of the Cascade system when using third party software.

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Starting a Remote Monitoring Session Initializing a Remote Monitoring Session from the Reader Before you begin •

Both systems must be turned on and logged into the same network, or a modemto-modem connection must be established. (See connection scenarios and setup instructions).

•

Cascade uses Distributed Com (DCOM) to share its application. DCOM does not SSL firewalls.

•

You must know the computer name and/or the IP address of the Cascade system you are connecting to. Cascade systems running version 1.8.11 or later will have their computer name and IP address of that system displayed at the bottom center of the Cascade application.

Computer Name & Workgroup

1. Right click on the My Computer Icon on the desktop, or from Windows Explorer, and select Properties. 2. Click on the Computer Name tab. Locate and write down the “Full computer name” and “Workgroup” listings in the middle of the window. Connecting the remote Reader system to the Cascade works best if both systems are part of the same Workgroup. Connection IP Address

1. To determine a system’s IP address click with your left mouse button once, on the far left of the dual computer monitor icon in the system tray, next to the system clock. There will be an icon there for every network and modem connection that is active on the system. 2. This will open a status window for that connection. For LAN connections click on the tab. This will only show the IP address for the system you are on. Write down the IP address. Click the Close button when you are done. 3. For modem connections click on the Details tab to display both the Cascade system (Server) and the Remote Reader system (Client) IP addresses. The Client always connects to the Server. The Reader always calls the Cascade. Initializing a Remote Monitor Session from the Reader

The Cascade system must be running a procedure. 1. Start the Cascade program on the Reader system. Click the “Remote Monitor” button.

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Elite Operators Manual 2. From the Connect to Server window, do one of the following then click OK: a. Type in the computer name of the Cascade system. b. Type in the IP address of the Cascade system. c. Select the computer name or IP address of the Cascade system from the list on the history tab. d. Select the computer name or IP address of the Cascade system from the list on the IOM Portal tab. Please note that the IOM Portal tab is only active for Cascade Elite systems with the Network Base Control license enabled. e. Click the Browse button and select the computer name from the list of computers available on the network. If the computer you are looking for does not appear on the list, this means the computer is not on the network.

2. Wait for the connection window. a. After a few seconds either a connection will be established or an error message will be displayed. See the Troubleshooting section for descriptions of possible error messages and their solutions. 4. Connection established. a. The Reader will initially see the same view as the Cascade. b. See the section on Remote Monitoring Features for description of what the Reader system can do during a remote monitoring session.

Initializing a Remote Monitoring Session from the Cascade Before you begin

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Both systems must be turned on and logged into the same network, or a modemto-modem connection must be established. (See connection scenarios and setup instructions.)

•

You must know the computer name and/or the IP address of the Reader system to which you are connecting. Cascade systems running version 1.8.11 or later will have their computer name and IP address of that system displayed at the bottom center of the Cascade application, as DAVIDMXP (10.1.1.123) is shown here:

Computer Name & Workgroup

1. Right click on the My Computer Icon on the desktop, or from Windows Explorer, and select Properties. 2. Click on the Computer Name tab. 3. Locate and write down the “Full computer name” and “Workgroup” listings in the middle of the window. Connecting the Cascade system to the remote Reader works best if both systems are part of the same Workgroup. Connect IP Address

1. To determine a system’s IP address, single-click the dual computer monitor icon in the system tray, next to the system clock. There is an icon for every network and modem connection that is active on the system. 2. This will open a status window for that connection. For LAN connections click on the tab. This will only show the IP address for the system you are on. Write down the IP address. Click the Close button when you are done. 3. For modem connections the Details tab to display both the Cascade system (Server) and the Remote Reader system (Client) IP addresses. The Client always connects to the Server. The Reader always calls the Cascade. Initializing a Remote Monitoring Session from the Cascade

The Cascade system must be running a procedure. 1. From the Remote Menu in the Cascade program select “Connect Reader (client)”.

2. From the Connect to Server window, do one of the following then click OK: a. Type in the computer name of the Reader system. b. Type in the IP address of the Reader system.

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Elite Operators Manual c. Select the computer name or IP address of the Reader system from the list. d. Click the Browse button and select the computer name from the network. 3. Wait for the connection window. After a few seconds either a connection will be established or an error message will be displayed. See the Troubleshooting section for descriptions of possible error messages and their solutions. Note this only works if the reader system is not currently viewing a procedure. If the remote reading system is already watching one or more Cascades then the remote connection must be initiated from the remote reader system. 4. Connection Established a. The Reader will initially see the same view as the Cascade. b. See the section on Remote Monitoring Features for description of what the Reader system can do during a remote monitoring session.

System Setup on the Remote Reader From the Edit menu, select System Setup. Then select the Remote tab. Remote Tab

Maintain View Synch with Server

Check this box on the Remote Reader system to automatically change views on the Remote Reader system when the Cascade system in the OR changes views. So both systems are always in the same view. Connection Speed

Used to specify the connection speed of the remote Reader client PC. Slow connections are not able to view live EMG, EEG, or Video. Each selection is labeled with its connection type.

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Chat Tab Auto Send Message

“On Enter Key” when this box is checked, chat messages will be sent when the Enter key is pressed. On Message

Auto Popup – when this box is checked, the chat message box will automatically be displayed when you receive a message. Beep – when this box is checked, you will hear a beep when a message is sent to you.

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Elite Operators Manual Save Log – used on the Cascade system, not the remote Reader system, to save the chat session as a *.txt document. Selecting this option on the remote Reader system will have no effect.

Chat Box To send a message to the Cascade or remote Reader system click on the system chat box icon in the tool bar. It will have the computer name or IP address of the system that is connected. The Cascade will see a box for each reader that is connected. The remote Reader will only see a box for the Cascade system. The remote reader will see the IP address or computer name and the patient name in the title bar of the chat window. Use the Chat tab in the Edit>System Setup window or click the Settings button in the Chat window to change your Chat box options.

Type your message in the lower portion of the Chat box. Press the Enter key on the keyboard or click on the Send button to send the message to the other system. Read the messages from the top portion of the Chat box. Move your Chat box to a desired location on the screen by using your mouse and grabbing the Chat window on the title bar. Close the Chat box by clicking the Close button.

Chat Log

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Remote Monitoring The option to save a chat log functions only on the Cascade acquisition system. By default the “Auto Send Message On Enter Key”, “Auto Popup” and “Beep” are selected. The Option to “Save to Log” is not. In order for the Chat log to be saved to a text file this box must be checked on the Cascade system. Checking this box on the Reader system will have no effect.

Sync with Server Use the Sync with Server button to re-establish the same view and parameters that are currently being used on the acquisition Cascade. The Sync with Server button is used to advance the Cascade application on the Reader system to the current live acquisition time. When looking back in time in an active procedure the acquisition appears to stop. The scroll bar at the bottom of the screen will turn yellow. Click on the Sync with Server button to advance the window to live acquisition time on the remote reader system. This also refreshes the chat window.

Views Views are a combination of windows grouped together to organize data. Available options for creating views on the Cascade system are dependent on the active modes in the procedure file that is being used. Views can be changed independently on the remote Reader system from the Cascade system. Both systems can rearrange windows within the view, switch views and add or remove windows within a view independently. Click the View button to advance to the next available view in the procedure file. It will cycle through all of the available views in the procedure. The View drop-down menu may also be used to select another view.

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Use the Edit> View Setup option to add and remove windows from within a view.

When you look back on the time line in a procedure use the Sync with Server button to take your view back to current time. The trace and background colors can also be changed independently on both systems. Go to Edit>System Setup and select the Colors tab. Looking back along the time line

Along the bottom of the Cascade application window there is a time scroll bar. Moving the gray block from the far right to the left will change the time you are looking at in the procedure from live time to the past.

The time scroll bar across the bottom of the screen will also turn yellow to let you know you are looking back in time and not viewing what is currently being recorded. There is also an absolute and real time display popup when you move the gray block in the time scroll bar to use as a reference.

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Remote Monitoring To go back to view the data that is currently being recorded in the case move the gray block in the time scroll bar all the way to the right, click the Live button or click the

Sync with Server button button.

or

Sync with Server button Live Mode

Reports Reports can be created independently on both the Cascade system and the remote Reader system. The report is generated from the data in the current view. The report template selected needs to match the windows that are in the current view. Selecting the Summary Window report template for an Average window will only generate patient information. The EP Window report template must be selected to produce the table and waveform data for an Average window view. The information that is pulled into the report is only for the time frame you are currently viewing. For best results use the File pull down menu and select Print Report. Select the All Windows.rpt report template. This will print tables and waveforms for all windows present in the view at that point in time. For an overall study text report select IOM Report - SSEP and EMG.rpt The ReportGenerator application is used for generating reports. It uses templates that are stored as .rpt files. Templates for each window type are "ed" so that you do not need to select a template every time. Templates are "ed" by window type, so if you print from one EP window, the same template will be selected by default for another EP Window. 1. Acquire new responses or open an existing file for review Reports can be generated both during the monitoring session and later in review. To open a file for review, select Review Procedure from the File drop-down menu. 2. Select the appropriate view The Report Generator creates reports with the data from the currently displayed View. Therefore, it is important to select the appropriate View and Elapsed Time in the record prior to initiating a report. 3. Initiate a report (select print) There are three methods that can be used to start a report. •

Method 1: Right-click the mouse on any window, and select Print from the menu.

•

Method 2: Select Print Report from the File drop-down menu.

•

Method 3: Click the Printer button at the top of the screen.

4. Select a report template

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Elite Operators Manual The Print Report window allows you to select the template that will be used to generate the report. If the Template field is blank, click the Select button to display a list of possible report templates. If you started the report process by rightclicking on an EP Average window, choose the template called EP Window. This will generate a report that includes the report header, patient information, traces, and cursor measurements from the window you selected. Once a template has been selected, click either the Print or Edit buttons (see step 5). The Cascade comes with several pre-installed templates. A template is a file that contains specific commands that tell the Report Generator what to include in the report. Basically, there is one template for each window type and also a template that prints all the windows in the current View. You can modify the pre-installed templates or create your own templates using the Template Editor application. 5. Choose print or edit Click the Edit button to start the Report Generator and display a window similar to a word processor program. You can make additions or changes to the report prior to actually printing it. Click the Print button to by the editing (word processor) mode, and send the report directly to the printer. 6. Report Generator program window If you clicked on the Edit button in Step 5, the Report Generator window will be displayed on top of the Cascade window. This window can be resized using the normal Windows controls. 7. Make Choice or Option selections depending on the template The Report Generator reads the report template file and inserts the requested Cascade data into the report. Depending on what the report template contains, the report generator will sometimes prompt the to select various choices from a list, or it may display a list of pre-programmed options that can be used to complete appropriate sections of the report. After the report template has been completely processed, the entire report document is displayed. 8. The report document The finished report document contains all the information specified in the report template. Usually, the document will start with a header that contains the address for the hospital or business. Next, the patient information is displayed followed by the graphics and data tables. Anything on the screen can be edited. Click the mouse where you want to make a change, and the blinking cursor will appear. Use the backspace key to delete the text then re-type the text the way you want it. To add to the report, click on a blank line then type the text you want to enter. If you want to delete an entire row from a table, like the cursor values table, click the mouse anywhere in the row you want to delete. The blinking cursor will appear. Then select "Delete Line" from the Table menu at the top of the screen. The 342

Remote Monitoring selected line will be removed. If you make a mistake, select "Undo" from the Edit menu. To move a page-break, click the mouse above the current page-break on the line where you want the new page-break to start. Then, select "Page Break" from the Insert menu. Use the formatting toolbar to make changes to the text size, add bolding or italics, or change the font style. 9. Save the Report (optional) The report can be saved as an RTF (rich text format) document. This is done by clicking on the appropriate toolbar button or by using the Save As (RTF) option in the File drop-down menu. The name of the document is automatically generated using the patient’s last and first names, (Last name, First name.rtf). Saved reports can be opened later using the Report Generator program or another word processing program. If you do not save the report and attempt to close the Report Generator, the program will automatically prompt you to make a choice. Select YES if you want to save the report, or NO if you don’t want to save the report. 10. Print the Report To print the report click on the printer toolbar button or select Print from the File drop-down menu to display the Print window. 11. Close the Report Generator Close the Report Generator by clicking on the "X" in the upper right corner of the report generator window or by selecting Close or Exit from the File drop-down menu.

Data Rates for Remote Monitoring % of Client Bandwidth Used Modem 56k bits/sec 7k bytes/sec Bits/sec 200k

Bytes/sec 25k

400%

DSL 256 bits/sec 32k bytes/sec 80%

120k

15k

300%

50%

1%

Video (30k per frame)

300k+

37.5k

600%

120%

3%

All of the above

620k

77.5k

1100%

250%

7%

DATA EPs live (4 modes with 3 traces, stored at 1k per trace) EMG (8 channels, 200ms/div sweep)

Ethernet 10M bits/sec 1250k bytes/sec 2%

For Real-Time monitoring <= 100%

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Disconnect When the remote Reader system is ready to disconnect from the Cascade before the case is over click on the Remote menu and select Disconnect. This option is only active on the remote Reader system. It will be grayed out on the Cascade system. Once the Cascade system closes the procedure the remote Reader system will automatically be disconnected.

Trouble Shooting Errors Remote Connection Failed

If the remote connection fails you will get an error. Reference the errors listed below to resolve your connection issue. In most cases, the DCOM settings only apply to the Cascade system unless you are using the Connect to Reader feature. Failed to connect to server. Result: 80070005

This is a DCOM configuration issue. Check the DCOM and Windows Firewall settings on both systems. Use the DCOM and Windows Firewall settings sections located in the help file to the Cascade system configuration. Note that Windows Firewall may not be the only firewall loaded on the system. Many virus protection software packages come with their own firewall. Failed to connect to server. Result: 800706ba

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This error could mean several different things. Either the system is not available on the network, or DCOM is being blocked by a firewall, or the NetBIOS name (computer name) is not being resolved to an IP address on the network, or a router/switch is blocking communication in one or both directions, or you need to open T port 135 on the network firewall. Try browsing to, searching for computer name. Try pinging the systems you are trying to connect to in each direction, both by NetBIOS name and IP address. the Anonymous is listed and all the allow boxes are checked for that in steps 12 & 21 of the DCOM settings. It is also important to there is communication between the two systems using the ping command. The Remote Reader should be able to ping the Cascade and the Cascade should be able to ping the Remote Reader. When pinging you want four replies. If you get one or more responses, “Request Timed Out”, repeat the ping again. If you consistently get four responses, “Request Timed Out” or “Destination Host Unreachable”, then there is an issue with both systems being on the same network or having bidirectional access to each other. If the ping command gives you four replies and there are no virus protection software/firewalls interfering with the Cascade and the Remote Reader then the DCOM configuration may need to be reset. An invalid argument was encountered

There is a Software version mismatch between the Cascade system and the Remote Reader system. Check the Cascade software version on both systems

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Elite Operators Manual under Help>About Cascade. They must both be running the same version of Cascade software. Failed to create the remote client object. Class not ed.

This refers to an incorrect registration of the Cascade.exe file in the system registry. Right click and select Com Server on the C:\Cadwell\Cascade.exe file on both the remote Reader system and the Cascade system, then reboot both systems to correct the problem. The remote machine is not licensed to be a server.

There is no license for the Remote Server option on the Cascade system. your sales person to purchase this option. If the Cascade system is licensed to be a Remote Server, reboot the Cascade system and try the connection again. The remote machine has not installed the option to be a server.

The Remote Server license is not enabled on the Cascade system under Edit>System Setup> Edit Customer Options. Check the Remote Server box. If you 346

Remote Monitoring cannot check the Remote Server box then the license is not enabled and will need to be purchased. Report Errors

Errors in report generation can be caused incorrect DCOM settings. This will cause the report generator not to function correctly. The messages below may appear, but no report will be created. To correct this issue change Default Distributed Com Authentication Level setting to “None” or “Connect”. See DCOM Configuration.

This is caused by an incorrect DCOM setting. This will cause the report generator not to function correctly. To correct this issue change Default Distributed Com Authentication Level setting to “None” or “Connect”. See page 21 Step #8.

Command Prompt The Command Prompt is a text based window used to type in commands in the Windows environment. The ping command is a T/IP utility used to test connectivity between two networked systems. To use the ping command: 1. Click on the Start menu button and select Run. 2. Type in CMD 3. Click the OK button. This opens the command prompt window. 4. Type in the word ping followed by a space then the IP address or computer name of the system with which you are testing the connection. (ping 192.168.0.11) 5. Press the Enter key on the computer keyboard. You will get four (4) replies if there is a connection. You will get four (4) requests timed outs if there is a problem with the connection.

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Elite Operators Manual To determine the network card IP address of a system in Windows XP: 1. Use the IPCONFIG command at the prompt line. 2. These commands will display the IP address and Subnet Mask for every network card and modem working on the system. 3. Type in IPCONFIG 4. Press Enter. 5. The IP address and subnet mask of the network card used for Cadwell hardware is 192.168.113.66 with a subnet mask of 255.255.255.0. This network card settings should not be changed.

Search for Computer The Search for Computer command function looks for computers out on the network. It is very similar to searching for files. You can use the wild card characters of “*” & “?” in the search parameters. Example to search for all computer names that start with a “c” use “c*” as the computer you are searching for. You can also search for a computer by it’s IP address. To use the Search for Computer function: 1. Right-click on the My Network Places icon on the desktop or under Windows Explorer 2. Select Search for Computer. 3. Enter the Computer name or IP address of the computer for which you are searching. 4. Click Search.

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Generating Reports Cascade Report Generation The Report Generation Process

Templates/Tokens What is a Template? What are Tokens?

A template is a file that contains specific commands, called tokens, which tell the Report Generator program the specific data to obtain from the Cascade program and include in the final report document. The template can also contain normal "text," like labels such 349

Elite Operators Manual as "Patient:" or "DOB:" or even entire paragraphs for things like normal results or conclusions. The order of the tokens and text in the template is important because the printed information will also appear in this order on the created document. So, if the first part of the template contains patient information tokens and then is followed by the token for waveforms this is how it will appear in the report document as well. The formatting of the tokens and text is also important. If the patient information tokens are "bolded" then this information will be bolded on the created document. If the cursor table token is set to a font size of 10 pt., then the cursor tables in the created document will be seen as 10 pt.

Steps for Report Generation The ReportGenerator application is used for generating reports. It uses templates that are stored as .rpt files. Templates for each window type are "ed" so that you do not need to select a template every time. Templates are "ed" by window type, so if you print from one EP window, the same template will be selected by default for another EP Window. Step 1 Acquire New Responses or Open an Existing File for Review.

Reports can be generated both during the monitoring session and later in review. To open a file for review, use the Review Procedure option in the File pull-down menu. To review a file that is not yet open, click Review Procedure on the Start Page.

Step 2 Select the Appropriate View

The Report Generator creates reports with the data from the currently displayed View. It is important to select the appropriate View and Elapsed Time in the record prior to initiating a report. Step 3 Initiate a Report (Select Print)

There are three methods that can be used to start a report. Method #1: Right click the mouse on any window and select Print from the pop up menu. The Print Report window will be displayed. Method #2: Select Print Report from the File pull-down menu. The Print Report window will be displayed.

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Generating Reports Method #3: Click on the Printer Icon at the top of the screen. The Print Report window will be displayed. Step 4 Select a Report Template

The Print Report window allows you to select the template that will be used to generate the report. If the Template field is blank, click on the Select button, and a list of possible report templates will be displayed. If you started the report process by right clicking on an EP Average window, choose the template called EP Window. This will generate a report that includes the report header, patient information, traces, and cursor measurements from the window you originally right clicked upon. Once a template has been selected, click on either the Print or Edit buttons (see step #5). The Cascade comes with several pre-installed templates. A template is a file that contains specific commands that tell the Report Generator what to include in the report. Basically there is one template for each window type and also a template that prints all the windows in the current View. You can modify the pre-installed templates or create your own templates using the Template Editor application. Please see Template Editor in the Help File on the installation CD for more information. Step 5 Choose Print or Edit

Clicking on the Edit button will start the Report Generator and will display a screen similar to a word processor program. You can make additions or changes to the report prior to actually printing it. Clicking on the Print button will by the editing (word processor) mode and will send the report directly to the printer. A window will pop up asking you where to save the report. Step 6 Report Generator Program Window

If you clicked on the Edit button in Step #5, the Report Generator window will be displayed on top of the Cascade window. This window can be resized or minimized using the normal windows controls. Step 7 Make Choice or Option selections depending on the template.

The Report Generator reads the report template file and inserts the requested Cascade data into the report. Depending on what the report template contains, the report generator will sometimes prompt the to select various choices from a list, or it may display a list of pre-programmed options that can be used to complete appropriate sections of the report (see examples below). After the report template has been completely processed the entire report document is displayed.

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Example of an Option selection window

Example of Choice selection window Step 8 The Report Document

The finished report document contains all the information specified in the report template. Usually, the document will start with a Header that contains the address for the hospital or business. Next, the patient information is typically displayed followed by the graphics and data tables. Anything on the screen can be edited except the graphics. Graphics cannot be cut and pasted.. Simply click the mouse where you want to make a change, the blinking cursor will appear. Use the backspace key to delete the text then re-type the text the way you want it. To add to the report, click on a blank line, then type the text you want to enter. If you want to delete an entire row from a table, like the cursor values table, click the mouse anywhere in the row you want to delete. The blinking cursor will appear. Now, select “delete line” from the Table menu at the top of the screen. The selected line will be removed. If you make a mistake, select “Undo” from the Edit menu.

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Generating Reports To move a page-break, click the mouse above the current page-break on the line where you want the new page-break to start. Then, select “Page Break” from the Insert menu. Use the formatting toolbar to make changes to the text size, add bolding, or italics, or change the font style.

Step 9 Save the Report (optional)

The report can be saved as an RTF (rich text format) document. This is done by clicking on the appropriate toolbar button or by using the Save As (RTF) option in the File pull-down menu. The name of the document is automatically generated using the patient’s last and first names, (i.e., Lastname, Firstname.rtf). Saved reports can be opened later using the Report Generator program or another word processing program. NOTE: If you save more than one report for a case, you will need to change the file name for each additional report saved.

If you do not save the report, when you close the Report Generator the program will automatically prompt you to make a choice. Select YES if you want to save the report, or NO if you don’t want to save the report. Clicking cancel will leave the report open. Step 10 Print the Report

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Elite Operators Manual To print the report click on the printer toolbar button File pull-down menu.

or select Print from the

Step 11 Close the Report Generator.

Close the Report Generator by clicking on the red “X” in the upper right of the report generator window or by selecting Exit from the File pull-down menu.

Default Report Templates Below is a list of the factory default report templates, including their names and descriptions. Reports can be saved as RTF files and can be opened for review using the Report Generator application or other word processing applications like Microsoft® Word®. EP Window – prints the contents of the selected EP Average window, including all currently displayed traces and a table of cursor values for those traces. MEP Window - prints the contents of the selected MEP Triggered window, including all currently displayed traces. Waterfall Window – prints the currently displayed traces of the selected Waterfall window. 3D Trend Window – prints the currently displayed traces of the selected 3D Trend window. Cursor Trend Window – prints the contents of the selected Cursor Trend window, including the Dot-To-Dot graph and the Table of currently displayed cursor values. EMG Window – prints currently displayed traces of the selected EMG window. Video Window – prints the currently displayed Video image. Event Window – prints the contents of the selected Event window, including all traces and a table of cursor values for those traces. The contents of the cursor table can be modified using the Setup Tables button in the Event Window Setup window. This report provides a summary of the important events that occurred during the procedure. Summary Window – prints the contents of the selected Summary window, including all traces and a table of cursor values for those traces. The contents of the cursor table can be modified using the Setup Tables button in the Summary Window Setup window. This report is used to print all the traces acquired for a mode during the procedure. All Stored EMG – prints a report which contains all the stored EMG windows that were saved during the procedure. A table of comments is also included for each stored EMG window. Pedicle Screw Stim Report w Waveforms - will automatically display the waveforms captured for each threshold event along with a table of stimulation locations, stimulus threshold values, and times of stimulation. 354

Generating Reports This report is available from within NerveGuard and when not in NerveGuard. All Windows – prints contents of all the windows in the currently selected View. PageHeader – this template is used by all of the other templates; it inserts the patient’s name and page number at the top of each page. Amplifier Setup – prints the layout of the amplifier inputs. Procedure Setup – prints a complete report of the procedure setup file, including amplifier setup, test montage, mode setups, channel settings, and views. CSA – prints the CSA analysis window. DSA – prints the DSA analysis window. EEG Traces – prints the Live EEG traces window. EEG Trends – prints the Trends analysis window. Symmetry – prints the Symmetry analysis window. IOM Report, SEP, and EMG – this is an example narrative template that contains Options and Choices, which are used to fill in the report sections. Pedicle Screw - prints a table of all the pedicle screw thresholds that were detected. Also includes EMG traces.

Report Templates and the Template Editor Program Appearance of a Typical Template Select the EP Window template, and click Open.

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Tokens are the basic building blocks of a template and are bracketed by a less-than symbol "<" on the left side and by a slash "/" and greater-than symbol ">" on the right. On a color screen, tokens are displayed in blue. The token for the test date will appear as follows: The token for the Cursor table results appears as follows: . If you accidentally remove the < or the /> the token becomes inoperable. Text that is entered into the template appears normally without any symbols bracketing it on either side. In the EP Window template, the words Current Date: are text that were simply typed into the template. Special tokens, like Option tokens, appear in green color on the screen.

Opening an Existing Template To open an existing template, click the Open toolbar button or select Open from the File drop-down menu. The Open Template window will display. Click on the template in the list to highlight it, and then click the Open button. The contents of the template you selected will be displayed on the screen.

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Template Editor The Template Editor program is used to create or edit report templates. The Template Editor is similar in appearance to a word processing program. Starting the Template Editor:

The Template Editor application is located in the C:\Cadwell\Quickmed folder on the hard disk drive. Double click on the file “TemplateEdit.exe” to start the program. NOTE: You can create a shortcut to the Template Editor program on your desktop by following these steps:

1. Right click on a blank area of the Windows Desktop. 2. Select New from the pop-up menu, then select Shortcut. 3. Click the Browse button. 4. Double click on the Cadwell folder. 5. Double click on the Cascade folder. 6. Double click on the file TemplateEdit.exe. 7. Click the Next button, then click the Finish button. The Template Editor program opens with a blank report template. To maximize the window, click on the middle button (maximize button) of the three buttons shown in the top right corner.

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There are two rows of toolbar buttons at the top of the Template Editor window. The first set of buttons are the standard buttons used for opening and saving templates.

The second set of buttons in the first row are used to select character style and size, and to format text.

The second row of buttons are used to insert special command tokens into the template..

The name of the template you are working on will be displayed in the title bar of this window.

Copying Templates The report templates can be easily copied from one Cascade to another. Copy the templates from the C:\Cadwell\Cascade\Data folder of the first Cascade onto a floppy diskette. Then, copy the templates from the floppy diskette into the C:\Cadwell\Cascade\Data folder of the second Cascade.

Customizing the Appearance of the Template Formatting a token

Formatting allows the data that the token represents to appear in a specific font style or size in the report. Highlight the token by clicking and dragging the mouse across it. Now, select the font style “i.e., Times Roman” and the character size “i.e.,

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Generating Reports 12” from the formatting toolbar at the top of the screen. The highlighted token will change its appearance on the screen to reflect the formatting you have selected. Now, click somewhere else to remove the highlight. NOTE: The EPWindowCursorTable data usually appears best in the Arial style at a size of 9 or 10 point.

Changing the alignment of a token

This allows the data to be centered on the line, or left justified, or right justified. Click the mouse at the beginning of the line to position the blinking cursor. Next, click on the appropriate alignment button in the formatting toolbar. The program inserts a token representing the alignment you selected. For example, if you selected the align center button, the token is inserted. All the lines in the template beginning with this one will be center justified. To return the alignment to the left edge of the page you will need to insert a Left Justify token on a line further down in the template. Inserting a blank line into the template

You can separate sections of the report by inserting blank lines. Simply click the mouse on a line to get the blinking cursor, then press the Enter key on the keyboard once for each blank line you want to insert. Inserting a manual Page Break into the template

Go to the line in the template where you want the page break to occur. Click the mouse on this line to position the blinking cursor. Now, right click the mouse and a pop-up menu of available procedures will be displayed. Select “Add Page Break” from this menu. A bold red line will be displayed in the template, this shows where the page break will occur. Entering plain text into a template

In addition to tokens, any plain text that you type into the template will appear in the final report. For example, if you are going to create a section for the Impression you might want to create a label in large bold letters called “Impression:”. Another example would be a signature line in the report. You could go to the bottom of the template and type your name as you want it to appear on the final report, “David Smith, MD”. If you have complete sentences or paragraphs of information that you always want to be included in your report you can type this as well. Removing tokens and text

The easiest way to remove tokens or text from a template is to position the cursor at the end of the information you want to remove and then use the “Backspace key” to delete it. Alternatively, you can use the mouse to highlight the information you want to remove and then press the “Delete” key.

Using a Page Header A page header is used to print specific information at the top of all printed pages, except the first page. This usually includes the patient name, test date, and page number. To 359

Elite Operators Manual use the Page Header feature, you must first create a page header template (containing the information you want in the page header), and insert this new template at the top of your existing report templates. To create a Page Header template

1. Start the Template Editor program. 2. The program opens with a blank template. 3. Insert the tokens representing the information you want included in the page header (lastname, firstname, testdate, etc.). See the example of tokens used for a page header.

4. To insert the page number, right-click the mouse, and select Insert Page Number from the menu. 5. Select the appropriate font style and size (Arial 10 pt. works well). 6. From the File menu, select Save As. 7. Type a name for the page header, such as "PageHeader," in the File Name field. 8. that the Save In field is set to the Data folder (C:\Cadwell\Cascade\Data). 9. Click the Save button. To insert a Page Header template into an existing report template

1. Start the Template Editor program. 2. From the File menu, select Open. 3. Select the template that you want to insert the Page Header into, and click Open. 4. Click the mouse at the end of the first line in the template. The blinking cursor will appear at that position. 5. Right-click the mouse, and select Page Header from the menu. The Open window displays, listing all Cascade templates.

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6. Select the PageHeader template, and click OK. 7. Select Save from the File menu to save the changes to the template. 8. Exit the Template Editor. .

Example “EP Window” template with a page header inserted on second line.

Customizing the Report Header

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Elite Operators Manual The report header is an RTF (rich text format) file that is created in the Cascade’s System Setup window. The Cascade saves this information in a file called "ReportHeader.rtf." To customize the Report Header

1. Start the Cascade program. 2. From the Edit menu, select System Setup. 3. Click the Report Header button. 4. Depending on the software installed on your computer, the report header file will be opened either with WordPad or Word 97/2000.

5. Change the information in the report header as needed. You can use bold text and different character sizes. All the lines should be "left justified" in this file. In order to center justify the report header, the report template must contain an Align Center token. See Customizing the Appearance of the Template. 6. To close the file, click on the "X" in the top right of the window. Select YES to save your changes, and to return to the System Setup window. 7. The System Setup window is re-displayed on the screen. Click “OK” to exit this menu.

Signatures in Reports Below is the important syntax that is in the report template. There are two sections for signatures in this example. Text color is not really important. Syntax is very important. The label “Clinical Neurophysiologist” will appear on the report followed by the signature for the selection you make.

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Generating Reports ends that section. You can add, remove or modify the OPTIONS. A box will appear showing each label, John Wright, M.D + others listed. goes to an RTF file (this must be in *.rtf format) The files must be located in the path indicated in the text. In the RTF file, example JohnWright.rtf there is syntax to point to a BMP or graphic file. This is the signature. Example of JohnWright.rtf file. John Wright, M.D The graphic must be in *.BMP format to work. The graphic must also be in the location listed in the path in the JohnWright.rtf file. You can choose your own folder structure or copy the one in this example. Example

Clinical Neurophysiologist /OPTION> /OPTION> /OPTION> /OPTION> /OPTION> /OPTION> /OPTION> /OPTION> /OPTION> /PROMPT> IONM Practitioner /OPTION>

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Elite Operators Manual /OPTION> /PROMPT> You can copy the syntax from this topic into a report template. Change the LBL text to match the correct names you will be using. Use the either IONM Practitioner or Clinical Neruophysiologist sections. Create an RTF file for each signature that points to the signature BMP file. You can copy the You may need to adjust the image size of the signature BMP file. Use the MS Paint program to do this. •

Start>All Programs>Accessories>MS Paint.

•

Always start with a copy of the original file so you can make several attempts at changing the image size until you find the correct one.

•

Image pull down menu>Stretch and Skew. Adjust the % size of the image.

•

Again make a copy of the original. Modify the copy.

•

Once you figure out the correct adjustment you can save the image. Modify the images from the correct folder listed in the rtf file. That is, put the image file copy in the new C:\ Cadwell\Signatures folder.

•

You will have to run the report to check the graphic size.

Note: the names used in this example are fictitious.

Cascade Tokens Listed below are the Cascade tokens (as of version 1.6) and a description of what they insert into the report. NOTE: There are other token groups that are not used by the Cascade Report Generator. These are the Easy EEG, Easy Sleep, and Sierra tokens. These tokens will not be discussed in this document.

Token Name:

Description of Token's function:

3DTrendTraces

Inserts the selected 3D Trend waveform graphic.

Age

Inserts the patient's age in years.

AllTables

Inserts cursor table information for All windows in the currently displayed View.

AllWaves

Inserts waveform graphics for All windows in the currently selected View.

AmpSetup*

Inserts the procedure setup file's amplifier input labeling scheme.

Anesthesiologist

Inserts the text from the Anesthesiologist field in the patient

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Generating Reports information window. Assistant

Inserts the text from the Assistant field in the patient information window.

Calibration

Inserts the waveform graphics for the Amplifier Calibration window.

Comments

Inserts the text from the Comments field in the patient information window.

CursorTrendWindowGraphs

Inserts the selected Dot To Dot cursor trend graphic.

CursorTrendWindowTables

Inserts the selected Cursor Trend Tables.

Diagnosis

Inserts the test from the Diagnosis field in the patient information window.

Diagnostics

Inserts the results for the Amplifier Diagnostics.

DOB

Inserts the patient's date of birth.

EEGAnalysisCSA

Inserts the CSA graphic.

EEGAnalysisDSA

Inserts the DSA graphic.

EEGAnalysisSymmetry

Inserts the DSA Symmetry graphic.

EEGAnalysisTrend

Inserts the trend graphic.

EEGWindowTraces

Inserts the EEG waveform graphic.

EMGComment

Inserts the EMG Comment.

EMGCommentTable

Used with the EMGWindowTracesAll token, it inserts the event text table for all the stored EMG.

EMGWindowPedicleTable

Inserts a table of the pedicle screw stimulus intensity threshold values that were detected using the NerveGuard feature.

EMGWindowTraces

Inserts the selected EMG window waveform graphic.

EMGWindowTracesAll

Inserts the waveform graphics for all stored EMG from the selected EMG window.

EPWindowCursorTable

Inserts the cursor table for the selected EP Average window.

EPWindowTraces

Inserts the waveform graphic for the selected EP Average window.

EPWindowTracesLarge

Inserts a high-resolution, large graphic for the selected EP Average window.

EventLog

Inserts a table of the Event log for the procedure including the priority.

EventWindowTables

Inserts the cursor table for the selected Event window.

EventWindowTraces

Inserts the waveform graphic for the selected Event window.

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Firstname

Inserts the text from the Firstname field in the patient information window.

Gender

Inserts either the Male or Female gender text.

Height

Inserts the text from the Height field in the patient information window.

LastName

Inserts the text from the LastName field in the patient information window.

MidInitial

Inserts the text from the Middle Initial field in the patient information window.

ModeSetups*

Inserts the information for each acquisition Mode in the procedure setup file including channel assignments, cursor setups, and stimulus parameters.

ORRoom

Inserts the text from the OR Room field in the patient information window.

PatientID

Inserts the text from the Patient ID field in the patient information window.

Setup*

Inserts all the setup information for the procedure setup file including amplifier labels, test montage, mode settings, and views.

SetupFileName*

Inserts the name of the procedure setup file.

StackedEMGTraces

Inserts the waveform graphic for the selected Stacked EMG window.

StackedEMGStimHistoryTables

Inserts the cursor table for the selected EMG Stim History window.

SummaryTable

Inserts the cursor table for the selected Summary window.

SummaryTraces

Inserts the waveform graphic for the selected Summary window.

Surgeon

Inserts the text from the Surgeon field in the patient information window.

Surgical Procedure

Inserts the text from the Surgical Procedure field in the patient information window.

Technician

Inserts the text from the Technician field in the patient information window.

TestDate

Inserts the date on which the procedure was started.

TestDateTime

Inserts the date and time of day when the procedure was started.

TestDuration

Inserts the duration of the procedure from start to close.

TestElapsedTime

Inserts the current elapsed time in the procedure.

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Inserts the time of day when the procedure was closed.

TestSetups*

Inserts the Test parameters of the procedure setup file.

TestTime

Inserts the time of day when the procedure was started.

TodaysDate

Inserts the current date.

TodaysDateTime

Inserts the current date and time of day.

TodaysTime

Inserts the current time of day.

TOFAnalysisTable

Inserts the cursor table for the selected TOF Analysis window.

TOFTraces

Inserts the waveform graphic and cursor table for the selected TOF Traces window.

Events*

Inserts a table of the Event list for the procedure setup file.

VideoComment

Inserts the Video Comment.

VideoImage

Inserts the selected Video Image.

ViewSetups*

Inserts a table of the View setups for the procedure setup file.

WaterfallTraces

Inserts the selected Waterfall window waveform graphic.

Weight

Inserts the text from the Weight field in the patient information window

* These tokens can only be used when printing the Procedure Setup File from within the Edit or Create New Procedure Setup window.

Choice Token A choice token allows the to make a choice between several words or short phrases. For example, you could have a sentence in your template that says, "Bipolar surface stimulating electrodes were placed over the surface of the ---- at the wrist". The possible choices could be "left ulnar nerve," "right ulnar nerve," or "bilateral ulnar nerves."

Insert a choice token into a template 1. Type the sentence leaving a blank space where the choice will occur. Now, go back and click the mouse on the blank space to get the blinking cursor. 2. Click on the Choice button (third from the left) in the special tokens toolbar.

3. The Set Choices window is displayed. Type the first choice on line one, the second choice on line two, etc. Each choice must be on its own line. After typing all the choices click on the OK button. Note: Check the “Allow Multiple Choices” box if you want to be able to select more than just one choice to complete the sentence.

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4. The Choice token will appear in the report template like the example below. Don’t worry that the choices are each on their own line. When the Choice token is processed the entire sentence will all be on one line. Bipolar surface stimulating electrodes were placed over the surface of the at the wrist. During the generation of the report the Select Choices menu will be displayed on the screen.

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To select a choice, click the mouse on the choice that you want. Click on the Done button after making your selection.

Inserting a Token into a Template First, you need to be able to view all of the available tokens. By default the template editor does not show the Cascade tokens. To turn "on" this group of tokens, go to the View menu, and click on Cascade in the list. You have to do this each time you start the template editor. Steps for inserting tokens for patient information or Cascade data

1. Click the mouse on the line where you want the token to be inserted. The blinking cursor should appear. 2. Click on the "Add Data" button in the special Tokens toolbar.

3. Select the Cascade token group from the left-hand column, then select the specific token from the right-hand column, and click OK. See the Cascade Token List window below.

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4. The token is inserted into the template. Repeat the above steps to insert other tokens. to separate tokens with spaces or commas, if needed.

Using Specialized Tokens Using Specialized Tokens A comment token will cause the report generator to pop-up a text-entry window during the creation of the report. These tokens can be used as an alternative to the fields in the Patient Information screen for entering additional patient comments, symptoms, or impressions. Shown below is the result of using a Comment token to enter Patient Symptoms into the report. NOTE: Comments cannot be pre-entered like the fields in the patient information window. They can only be entered during report generation.

To insert a comment token into a template:

1. Enter a text label for the comment (i.e., Symptoms:) on the line where the comment token will be inserted. See entering plain text in the Customizing the Appearance of the Template topic. 2. Click the mouse just after the label you entered or on the next line down. The blinking cursor will appear on the line. 3. Click on the Insert Comment button in the special tokens toolbar. 4. The Add Comment window will be displayed. You need to type a message that will be displayed during the report generation. For example, if this comment 370

Generating Reports token is being used for the Patient Symptoms section you could type “Enter Patient Symptoms” for the prompt. If it was for the Supplies Used section, you could type “Enter the Supplies Used”. Then, click OK. 5. The comment token is entered into the template and would look similar to this example. NOTE: If you Cancel the comment during report generation the text label “Symptoms:” will still be displayed in the report.

Prompt/Option Token

This type of token is used to pre-enter two or more sentences or paragraphs of text into the template. During the report generation, the can choose which pre-entered option they want to use in the report. If none of the options are appropriate the has the ability to type something different. As an example, you might want to have two different impression statements. The first can be the normal statement "SEP recordings showed no significant changes during the procedure." The second can be the abnormal statement "SEP recordings showed a significant change during this procedure with incomplete recovery before closing." To insert the above Prompt/Option combination into a template

1. Enter a text label for the section (i.e., Impressions:) on the line where the prompt/option token will be inserted. See entering plain text in the Customizing the Appearance of the Template topic. 2. Click the mouse just after the label you entered or on the next line down. The blinking cursor will appear on the line. 3. Click on the Prompt button in the special tokens toolbar. 4. The insert prompt window will be displayed. Use the mouse to put a check mark in the box “Allow More Than One” and another check next to the “Show Text Box”. Ignore the section called Separators. This is not used. 5. In the Instructions field, type “Select the Impression Option”. During the generation of the report this will be displayed for the instructions. 6. Next, click on the “OK+Add Option” button at the bottom of the window. The Insert Option window will be displayed. 6. The first option will be the normal statement. In the Label field type “Normal SEPs”. Now, type the body of the statement in the text field. See example below. 7. To add the abnormal statement click on the “Add Another Option” button. Do Not Click on the OK button, this will take you out of the insert option window. 8. In the Label field type “Abnormal SEPs”. Now, type the body of the statement in the text field. 9. Since all the options have been entered you can now click on the OK button. 10. The Prompt/Option tokens will appear like this in the report template. Impression:
Elite Operators Manual /PROMPT> During the generation of the report the following menu will be presented to the . To select an option, click on it with the mouse. The selected option will appear in blue color and the contents of the option will be displayed at the top of the window. Click OK to continue processing the remainder of the report Choice Token

A choice token allows the to make a choice between several words or short phrases. For example, you could have a sentence in your template that says, "Bipolar surface stimulating electrodes were placed over the surface of the ---- at the wrist". The possible choices could be "left ulnar nerve," "right ulnar nerve," or "bilateral ulnar nerves." Insert a choice token into a template

1. Type the sentence leaving a blank space where the choice will occur. Now, go back and click the mouse on the blank space to get the blinking cursor. 2. Click on the Choice button in the special tokens toolbar. 3. The Set Choices window is displayed. Type the first choice on line one, the second choice on line two, etc. Each choice must be on its own line. After typing all the choices click on the OK button. Note: Check the “Allow Multiple Choices” box if you want to be able to select more than just one choice to complete the sentence. 4. The Choice token will appear in the report template like the example below. Don’t worry that the choices are each on their own line. When the Choice token is processed the entire sentence will all be on one line. Bipolar surface stimulating electrodes were placed over the surface of the at the wrist. During the generation of the report the Select Choices menu will be displayed on the screen. To select a choice, click the mouse on the choice that you want. Click on the Done button after making your selection. Choices within Options

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Generating Reports A very powerful feature is the ability to embed Choices within an Option. This allows you to use an Option for many different scenarios. Shown below is the previous example of two simple Options; Normal SEPs and Abnormal SEPs. By inserting choices into the text for the Abnormal SEPs option you can make this option fit many different scenarios.

Comment Token A comment token will cause the report generator to pop-up a text-entry window during the creation of the report. These tokens can be used as an alternative to the fields in the Patient Information screen for entering additional patient comments, symptoms, or impressions. Shown below is the result of using a Comment token to enter Patient Symptoms into the report.

The person generating the report can type the symptoms into the space provided or they could click the Cancel button to skip this comment and leave it blank. NOTE: Comments cannot be pre-entered like the fields in the patient information window. They can only be entered during report generation.

To insert a comment token into a template:

1. Enter a text label for the comment (i.e., Symptoms:) on the line where the comment token will be inserted. See entering plain text in the Customizing the Appearance of the Template topic. 2. Click the mouse just after the label you entered or on the next line down. The blinking cursor will appear on the line. 3. Click on the Insert Comment button (light bulb, second from right) in the special tokens toolbar.

4. The Add Comment window will be displayed. You need to type a message that will be displayed during the report generation. For example, if this comment 373

Elite Operators Manual token is being used for the Patient Symptoms section you could type “Enter Patient Symptoms” for the prompt. If it was for the Supplies Used section, you could type “Enter the Supplies Used”. Then, click OK.

Add Comment window

5. The comment token is entered into the template and would look similar to this example. Conclusions: NOTE: If you Cancel the comment during report generation the text label “Symptoms:” will still be displayed in the report.

Prompt/Option Token This type of token is used to pre-enter two or more sentences or paragraphs of text into the template. During the report generation, the can choose which pre-entered option they want to use in the report. If none of the options are appropriate the has the ability to type something different. As an example, you might want to have two different impression statements. The first can be the normal statement "SEP recordings showed no significant changes during the procedure." The second can be the abnormal statement "SEP recordings showed a significant change during this procedure with incomplete recovery before closing." To insert a Prompt/Option combination into a template

1. Enter a text label for the section (i.e., Impressions:) on the line where the prompt/option token will be inserted. See entering plain text in the Customizing the Appearance of the Template topic. 2. Click the mouse just after the label you entered or on the next line down. The blinking cursor will appear on the line. 3. Click on the Prompt button (far left) in the special tokens toolbar.

4. The insert prompt window will be displayed. Use the mouse to put a check mark in the box “Allow More Than One” and another check next to the “Show Text Box”. Ignore the section called Separators. This is not used.

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5. In the Instructions field, type “Select the Impression Option”. During the generation of the report this will be displayed for the instructions.

6. Next, click on the “OK+Add Option” button at the bottom of the window. The Insert Option window will be displayed. 7. The first option will be the normal statement. In the Label field type “Normal SEPs”. Now, type the body of the statement in the text field. See example below.

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8. To add the abnormal statement click on the “Add Another Option” button. Do Not Click on the OK button, this will take you out of the insert option window. 9. In the Label field type “Abnormal SEPs”. Now, type the body of the statement in the text field. See example below.

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10. Since all the options have been entered you can now click on the OK button. 11. The Prompt/Option tokens will appear like this in the report template. Impression: /PROMPT> During the generation of the report the following menu will be presented to the .

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To select an option, click on it with the mouse. The selected option will appear in blue color and the contents of the option will be displayed at the top of the window. Click OK to continue processing the remainder of the report.

Choices within Options A very powerful feature is the ability to embed Choices within an Option. This allows you to use an Option for many different scenarios. Shown below is the previous example of two simple Options; Normal SEPs and Abnormal SEPs. Simple Options

Abnormal Option expanded with Choices

By inserting choices into the text for the Abnormal SEPs option you can make this option fit many different scenarios.

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Inserting the Contents of RTF/Bitmap Files The contents of an RTF (rich text format) file or a bitmap can be included in a template. An RTF file is a text file that is created with a word processor program such as WordPad or Word97. In fact, the customized report header that appears at the top of every report is placed at the top of the template by inserting the RTF file "ReportHeader.rtf" as the first line in each template. Bitmap files can also be inserted into a template. For example, you might want to insert a picture of your company logo into your report. To insert an RTF file or bitmap file into a template

1. Click on the line in the template where the RTF or bitmap file should be inserted. The blinking cursor displays. 2. Right-click the mouse, and select Insert File from the menu. 3. If necessary, change the Look In and File Type fields until you find the appropriate RTF or Bitmap file. 4. Select the file, and click Open. 5. The Insert File command is placed into the template. 6. Select Save from the File menu to save the changes to the template. .

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NOTE: To center the header or bitmap, place an Align Center token at the beginning of the line. Make sure to insert an Align Left token on the next line.

Saving Templates Saving changes to a template

To save changes to the template, select "Save" from the File menu or click the Save button at the top of the screen. Saving as a new template

To save the template as a new report template, select Save As from the File menu. Enter a name for the template in the File Name field. that the Save In field is set to the Data folder (C:\Cadwell\Cascade\Data). Click the Save button.

Closing the Template Editor To close the Template Editor, click on the "X" in the upper right-hand corner of the window or select Exit from the File menu.

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Safety Information General Warnings and Precautions Warnings and Precautions U.S. Federal law restricts the use of this system by, or under the supervision of, a physician. This unit is not waterproof. Do not immerse the base unit, power/communications module, stimulus splitters, VEP goggles, auditory stimulators, flash stimulator, system cables, or any other system components in liquid. Do not try to service unit. Service is to be done by Cadwell and other authorized bodies only. Adhere to the unit cleaning instructions. Always disconnect equipment from power source and patient before cleaning. Connection of patient to high frequency electrosurgical equipment and electroneurodiagnostic equipment simultaneously may result in burns at the site of the electrical stimulator and/or amplifier electrodes, and possible damage to the electrical stimulator and/or amplifier. Inspect cables before and after each use. Discard and replace cable if insulation is damaged or if the cable or connectors are loose or damaged in any manner. The operator must be trained to be able to recognize the difference between signal artifacts and valid biosignals caused by movements, interference, or misplacement of sensors or electrodes. The proper use of this device for its intended purpose can only be assured once all instructions have been read and understood. If there are any questions regarding the operation of the Cascade Elite system, Cadwell. The manual provides an operational summary for the Cascade Elite system. It does not provide clinical training. The must have adequate clinical training to perform procedures. Place system components where they are safe from with spilled fluids. Wrapping or covering the base unit may cause excessive heat buildup leading to amplifier failure. Patient movement may occur during stimulation leading to inadvertent neural injury. Take adequate steps to avoid stimulation when patient movement could cause injury.

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Elite Operators Manual When delivering stimulation that may cause jaw movement, use bite blocks to minimize the risk of tongue-biting injuries and mandibular fracture. Routinely check bite blocks for displacement. The system is not designed to operate in an explosive environment or in the presence of flammable anesthetics. The system is designed to be used on one patient at a time. Do not connect multiple patients to one amplifier. Avoid accidental between electrodes connected to patient and other conductive parts, including earth ground. Avoid accidental between unapplied electrodes connected to the amplifier and other conductive parts, including earth ground. Review TCS amplitude-pulse train safety chart prior to performing TCeMEPs. Keep anode and cathode stimulating sites in close proximity. The Cascade Elite amplifier inputs are Type BF rated. BF rating ensures that no current higher than 50uA flows to or from the applied part if mains voltage is inadvertently connected to the patient. Transcranial cortical stimulation may not be appropriate for use on patients with a history of skull fracture or neurosurgical procedures to the head. Skull defects could provide high local current densities. Cortical stimulation may induce seizures and memory problems in those with a history of epilepsy and other disorders with predisposition to seizures (e.g. alcoholism). Ensure that necessary medical precautions are taken in case of such an episode. Display EEG data during cortical stimulation such that seizure activity can be easily detected. Otherwise unexplained intraoperative seizure and/or arrhythmia are indications to abort transcranial or direct cortical stimulation. The safety of pulse train frequencies below 250 Hz (interstimulus interval above 4 ms) for cortical stimulation has not been studied in clinical literature. Operation in close proximity to short wave or microwave therapy equipment may produce instability in the electrical stimulator output. This system is not MRI compatible. The system is not defibrillator proof.

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Safety Information The Cadwell flash stimulator must be at least 12 inches (30 cm) away from the patient’s eyes. If used on an anesthetized patient a means should be provided to ensure that the eye lids remain closed. The use of the Cadwell flash stimulator may induce seizures in epileptics or people prone to epilepsy. Persons who are photosensitive to light may have convulsions, seizures, or a myoclonic reaction to the photic stimulator. The operator must be trained to recognize EEG waveforms and patient symptoms that are consistent with a patient’s reaction to photic stimulation. The operator must follow laboratory medical policies and procedures when using the flash stimulator to care for the patient undergoing photic stimulation. When attaching the Cascade Elite system to a recording subject, that the subject will not become entangled in the wires. Do not allow the electrode wires to wrap around the subjects neck. Do not clean Cascade before turning off power supply and disconnecting all Cascade components. Do not clean Cascade components before turning off power supply and disconnecting the amplifier. Do not attempt to service or repair damaged or inoperable equipment. Some of the warnings listed above are referenced from Safety Standards EN 60601-1and EN 60601-2-40. There are applications in which the benefits of the test should be weighed against possible adverse effects. This judgment is best left to a skilled clinician familiar with the characteristics of the device. These applications include the following: •

Use of high current stimulator with intramuscular EMG needle electrodes

•

Use of high current stimulator for direct nerve stimulation

•

Use of current densities for any electrode exceeding 2mA r.m.s./sq. cm

•

Prolonged, rapid, high current stimulation at any site, especially with long pulse durations

•

Transthoracic stimulation

•

Stimulation with needles having extremely small surface areas that easily exceed 2mA r.m.s./sq. cm. when stimulated

•

Use during pregnancy

•

Direct nerve stimulation and direct stimulation of the spinal cord, muscle, and brain

•

Transcranial and direct electrical stimulation of the brain

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TCS Warnings and Precautions Read this carefully before use. This topic will help you understand the general warnings and cautions associated with the TCS-1/TCS-1000/TCS-4 system. It is important that the /operator understand all warnings and cautions associated with the system. Sections marked with an exclamation mark should be read carefully before using the TCS system.

Warnings and Cautions Federal law restricts the sale of this system to, or on the order of, a physician. High levels of static discharge can cause a momentary pause in data collection. No serviceable parts inside. Service by Cadwell Laboratories, Inc. and other authorized bodies only. Do not connect leads to anywhere other than the head. This eliminates the potential for transthoracic currents in any failure mode. Always connect channel 1 of the TCS-4. This channel has the patient static equalization circuit for the stimulator. Failure to connect channel 1of the TCS-4 may result in electrostatic discharge just prior to stimulation which may cause excessive stimulation artifact. Inspect all cables before and after each use. Discard cable if insulation is damaged or if the cable or connectors are damaged in any manner. Do not immerse any TCS unit in liquid. Do not attempt to use the system if it has been immersed in liquid. The system is neither water resistant nor splash proof. of liquids with the internal parts and connectors of Cadwell TCS systems should be avoided at all times. Cortical stimulation may not be appropriate for use on patients with a history of skull fracture or neurosurgical procedures to the head because the skull defects could provide high local current densities. Cortical stimulation may induce seizures and memory problems in those with a known history of epilepsy and other disorders with a predisposition to seizures (e.g. alcoholism). Ensure that necessary medical precautions are taken in case of such an episode. Use bite blocks in the patient due to the risk of tongue biting injuries and mandibular fracture. Routinely check bite blocks for proper placement. Patient movement may occur during stimulation, leading to inadvertent neural injury. Take adequate steps to avoid stimulation when patient movement could

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Safety Information cause injury. Review TCS amplitude-pulse train safety chart prior to performing TCeMEPs. The safety of pulse train frequencies below 250 Hz (interstimulus interval of 4 msec) has not been studied in clinical literature. Cleaning instructions in this manual need to be strictly adhered to. Otherwise unexplained intraoperative seizures and possible arrhythmias are indications to cease use of any TCS. TCS outputs must be connected to the stimulating electrodes only. Unintentional misconnection of the outputs to ground electrodes could result in current being dangerously applied to organs other than the cerebral cortex. The system is not designed to operate in an explosive environment. Not for use in the presence of explosive atmosphere or flammable anesthetics. Do not autoclave. Display EEG data on a separate monitor than that used to display SEP or EMG, such that seizure activity can be easily detected. Studies by Calancie et al. relied upon to demonstrate safety and effectiveness of the device employed threshold level monitoring to increase patient safety by minimizing energy delivered. Connection of patient to high frequency electrosurgical equipment and electroneurodiagnostic equipment simultaneously may result in burns at the site of stimulation and possible damage to the electrical stimulator. Due to possible adverse effects, such as chemical and heat burns, stimulation with current density greater than 2mA r.m.s./cm2 may require the special attention of the operator.

Contraindications Comprehensive relative contraindications include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices.

Symbols Symbol

Title/Meaning

Reference

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, or , or

, or

386

Attention, consult accompanying documents.

IEC 348

Dangerous voltage

IEC 878

Power ON

IEC 878

Power OFF

IEC 878

Equipotentiality

IEC 878

Type BF equipment. Isolated patient connection.

IEC 878

Output

IEC 878

Input

IEC 878

Variability in steps

IEC 878

Plus; positive polarity

IEC 878

Minus; negative polarity

IEC 878

Direction of nerve depolarization

Cadwell convention

Visual Evoked Potential Display

Cadwell convention

Temperature

IEC 878

Foot switch

IEC 878

Headphone

IEC 417

Safety Information

Amplifier

Reduction of Hazardous Substance Compliant

Cadwell convention RoHS

Link

Cadwell convention

Status

Cadwell convention

Data transferring

Cadwell convention

Trigger

Cadwell convention

EMG/EP/EEG equipment with respect to electric shock, fire, and mechanical hazards only in accordance with UL 2601-1 and CAN/CS A C22.2 No. 601-1 (XXXXX)

ITS

Declaration of compliance with the provisions of council directive 93/42/EEC concerning medical devices (applies only to equipment so marked and only in the countries stated on the declaration of conformity for the device).

KEMA Medical Notified Body

Waste Electrical and Electronic Equipment Do not throw in standard garbage. Recycle or dispose of equipment according to regulatory requirements of your country

WEEE

Verification of Proper Operation Proper operation of equipment must be verified prior to surgical procedure. A preoperative evaluation is performed to proper setup and operation prior to the istration of anesthesia or muscle relaxants. This check is performed to that 387

Elite Operators Manual equipment is operating properly and that the system is set up correctly for the procedure. During this pre-op check, the integrity of all system and electrode connections, and double-check the setup. Next, check electrode impedance, and measure nervous system responses. This will establish a baseline response to which responses obtained during the procedure can be compared.

Operating Environments & Limits The operating environment for this product should meet the following criteria: 1. An ambient temperature range of 50°F to 104°F (10°C to 40°C). 2. A relative humidity range of 30 percent to 95 percent non-condensing 3. An atmospheric pressure range of 700 hPa to 1060 hPa.

Transportation & Storage Limits Do not expose to temperatures Below -4°F (-20°C) or Above 149°F (65°C) . Do not expose to relative humidity below 10 percent or above 95 percent (noncondensing). Do not expose to atmospheric pressures below 500 hPa or above 1060 hPa. P/N 823014-000

Electrical Safety Requirements and Allowable Configurations Cadwell electrical safety requirements and allowable IEC 60601-1-1 System Configurations

GENERAL DISCUSSION The application of modern electronic technologies in medical practice has led to systems of medical and non medical electrical equipment being used together for the diagnosis and monitoring of patients. Medical Electrical equipment complying with IEC 60601-1 such as Cadwell equipment and accessories are often connected to other, non medical electrical equipment such as computers and printers. Non-medical electrical equipment may fully meet the requirements applicable in their specific field, but may not comply with isolation or leakage requirements for MEDICAL ELECTRICAL EQUIPMENT and thereby impact the safety of the entire MEDICAL ELECTRICAL SYSTEM. The following configurations ensure that combinations of Cadwell devices and nonmedical electrical equipment comply with the electrical safety requirements for MEDICAL ELECTRICAL SYSTEMS.

ALLOWABLE CADWELL SYSTEM CONFIGURATIONS 1. All Cadwell equipment and accessories are permissible in the PATIENT ENVIRONMENT without incorporating a SEPARATING TRANSFORMER.

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Safety Information 2. A double insulated Laptop Computer powered from Cadwell equipment is permissible in the PATIENT ENVIRONMENT without incorporating a SEPARATING TRANSFORMER. 3. Other computing devices (i.e. desktop computer, monitor, printer, camera, IR illuminator etc.) are NOT allowed in the PATIENT ENVIRONMENT unless a SEPARATING TRANSFORMER is used to power those devices. 4. Non medical devices (examples in #3 above) may be used outside the PATIENT ENVIRONMENT within the MEDICALLY USED ROOM without incorporating a SEPARATING TRANSFORMER, provided each individual device is plugged into a FIXED MAINS SOCKET OUTLET. Otherwise a SEPARATING TRANSFORMER must be incorporated. 5. MULTIPLE PORTABLE SOCKET OUTLETS (power strips) are not permitted in a MEDICALLY USED ROOM unless connected to the output of a SEPARATING TRANSFORMER. 6. Connection to hospital networks is allowed without incorporating a SEPARATING DEVICE as long as the network server and the MEDICAL ELECTRICAL SYSTEM are connected to circuits powered from and grounded to the same electrical service entrance. 7. Cascade PRO shall be used only with Cadwell Cascade PRO Power Supply 229038-000.

SYSTEM REQUIREMENTS 1. Non medical electrical equipment used in MEDICAL ELECTRICAL SYSTEMS must meet their respective IEC electrical safety requirements, i.e. IEC 950 for computing devices. 2. ENCLOSURE LEAKAGE must not exceed 500uA in any SINGLE FAULT condition within the PATIENT ENVIRONMENT. 3. ENCLOSURE LEAKAGE must not exceed 100uA in normal condition. 4. EARTH LEAKAGE must not exceed 500uA in any single fault condition within the PATIENT ENVIRONMENT. 5. The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 1500 volts isolation between patient and earth. 6. The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 4000 volts isolation between patient applied parts and mains voltage. 7. The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 1500 volts isolation between non-patient parts of the SYSTEM and mains voltage. 389

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GENERAL WARNINGS AND PRECAUTIONS 1. DO NOT place ISOLATION TRANSFORMERS or MULTIPLE PORTABLE SOCKET OUTLETS on the ground. 2. DO NOT connect MULTIPLE PORTABLE SOCKET OUTLETS (power strips) to the system, unless connected downstream of an isolation transformer. 3. DO NOT connect items which are not specified as part of or for use with the SYSTEM. 4. DO NOT exceed the medical isolation transformer placarded maximum load. 5. DO NOT use medical isolation transformer provided with the system to power non-system components as this can overload the transformer, or defeat the separation by providing additional leakage sources. 6. DO NOT plug non-medical electrical equipment intended for use in the PATIENT ENVIRONMENT directly into a wall outlet as this can potentially result in excessive leakage current present in the patient environment.

DEFINITIONS 1. MEDICAL ELECTRICAL EQUIPMENT: Electrical equipment, provided with not more than one connection to a particular supply mains and intended to diagnose, treat, or monitor the patient under medical supervision and which makes physical or electrical with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient. 2. MEDICAL ELECTRICAL SYSTEM (SYSTEM): combination of items of equipment, at least one of which must be MEDICAL ELECTRICAL EQUIPMENT and interconnected by functional connection or an ISOLATION TRANSFORMER. 3. PATIENT ENVIRONMENT: any volume of space (area) in which intentional or unintentional can occur between PATIENT and parts of the SYSTEM or between PATIENT and other persons touching parts of the system. For practical purposes this is an area 1.5 meters or 5 feet beyond reach of the patient. 4. MEDICALLY USED ROOM: the room in which the PATIENT ENVIRONMENT is located. 5. SEPARATING TRANSFORMER: medical ISOLATION TRANSFORMER designed to limit transfer of unwanted leakage current and allow non-IEC 606011 devices to be located in the PATIENT ENVIRONMENT. 6. SEPARATING DEVICE: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of the MEDICAL ELECTRICAL SYSTEM. 390

Safety Information 7. FIXED MAINS OUTLET: permanently installed (hard wired) grounded outlet in a facility. 8. MULTIPLE PORTABLE SOCKET OUTLET (power strips): a combination of two or more socket-outlets intended to be connected to, or integral with, flexible cables or extension cords. 9. SINGLE FAULT: Condition in which a single means for protection against a safety hazard in the SYSTEM is defective or a single external abnormal condition is present.

Cadwell Quality/Regulatory department at 509.735.6481 with any questions regarding these requirements. P/N 309002-000 Rev03

Electromagnetic Compatibility This medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided below. Portable and Mobile RF communications equipment can affect medical electrical equipment. Use of accessories and cabling other than those specified in below, with the exception of those sold by Cadwell as replacement parts, may result in increased emissions or decreased immunity of the Cascade Elite system. Cascade Elite unit – 190239200

Cable, Cascade ES-5 – 355292200

Cascade base unit – 100820200

Cable, MES-10 / SII Interface – 199232-200Stimulator, CV-2 dual constant voltage – 190197-200

Cascade PRO base unit – PRO power supply 229038-000 Cascade Software – 369028200 Input extender, 6 meter – 362041-000 Input extender, 3 meter – 362040-000 Impedance test array – 360048-200 Impedance test array –

Stimulator, TCS-1 transcranial – 190227-200 Stimulator, TCS-1000 transcranial – 190258-200 Stimulator, TCS-4 transcranial – 190261-200 Electro surgery detector, 4 input – 190198-200 Electro surgery current sensor – 190199-200

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Elite Operators Manual 360049-200 Impedance test array 190267-200

ES detector module – 190235200 ES detector clip – 190236-200

Amp, 8 channel – 190193200

Electro surgery detector, 4 input – 190198-200

Amp, 16 channel – 190194200

Electro surgery current sensor – 190199-200

Cascade PRO Amp, 16 channel - 190265-200

TDH-39 adult headphones – 199219-200

Input extender, 6 meter – 199233-200

TDH-39 lightweight headphones – 199220-200

Input extender, 3 meter – 199231-200

Insert earphones – 291151-000 Cable, insert earphone quick connect – 355322-200

Input extender, 6 meter – 199261-200-003

Bone Vibrator – 199224-200

Input extender, 3 meter – 199261-200-006

Headphone extension cable – 355295-200

Amp cable, 3 meter – 362031-000

VEP LED module – 199217200

Amp cable 25’ – 362029-000 Amp cable, 9" - 199262-200 Impedance test array – 197212-200 ES-IX Stimulator – Stim splitter, ES-5-1 – 190195-200 Stim splitter, ES-5-2 – 190196-200 Stim splitter, ES16-20 – 190201-200 Stim splitter, ES5-5 – 190203-200 Stim splitter, ES5-20 – 190204-200 Stim Splitter, ES5-5V – 190205-200 Stim Splitter, ES5-100 – 190221-200 Cable, ES-IX, 3 meter 392

Quick Connect LED goggles – 199253-200 LED goggles – 199218-200 Power com module – 190240200 Flash stimulator – 190182-200 Flash stimulator (LED) – 190228-200 Isolation transformer – 197205-200 Cable, aux. 25’ extension – 355258-200 Cable, 10’ aux quick connect – 355320-200 Cable, 25’ aux quick connect – 355325-200 Cable, 15 pin auditory stim extension – 355326-200 Cable, 25’ power/com – 362042-000

Safety Information 362049-200-003

Cable, 3” LED Sierra – 355281200

Cable, ES-IX, 6 meter 362049-200-006 Cable, Daisy Chain, ES-IX 199269-000 ES-IX Test Array - 190268200

Cascade PRO Amp Holder 197245-200 Cascade PRO Tray - 3361448000

Cable, Elite, ES, 10’ – 355319-200 Cable, Elite, ES, 25’ – 355324-200 Cable, Elite, ES-5 5ft. interconnection – 355294200

Guidance and manufacturer’s declaration – electromagnetic emissions The Cadwell Cascade Elite IOM system is intended for use in the electromagnetic environment specified below. The customer or the of the Cascade Elite should assure that it is used in such an environment

Emissions test RF Emissions

Compliance

Electromagnetic environment - guidance

Group 1

The Cascade Elite uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

The Cascade Elite IOM system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpose.

CISPR 11

RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not Applicable as device draws less than 50 watts. Cadwell declares the Cascade Elite does not produce voltage fluctuations/ flicker emissions

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Elite Operators Manual The Cascade Elite should not be used adjacent to or stacked with any other equipment. If adjacent or stacked use is necessary, performance of the Cascade Elite should be observed to normal operation in the configuration in which it will be used. Guidance and manufacturer’s declaration – electromagnetic immunity The Cadwell Cascade Elite IOM system is intended for use in the electromagnetic environment specified below. The customer or the of the Cascade Elite should assure that it is used in such an environment

Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

±6 kV

±6 kV *

±8 kV air

±8 kV air*

IEC 61000-4-2

Electromagnetic environment - guidance Electrostatic discharge at ANY level will produce noise glitches on the Cascade display screen. These noise glitches are easily differentiated from biopotential input signals. ESD noise is unavoidable in high static environments due to the high input sensitivity of the equipment. To minimize electrostatic effects, floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Large Electrostatic discharge may trigger stimulator error dialogue box. A mouse click is required to reset the dialogue box. This is an intentional error message so there is no possibility of ESD unintentionally triggering the stimulator.

±2 kV for power Electrical fast supply lines transient/burst

IEC 61000-4-4

±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

EFT’s may cause events in the display waveforms. This is an unavoidable phenomenon due to the high input sensitivity of the equipment. These waveform disturbances can be differentiated from physiological events. To minimize these effects, mains power quality should be that of a typical commercial or hospital environment. High level EFT’s may trigger a stimulator error dialogue box. A mouse click is required to reset the dialogue box. This is an intentional error message so there is no possibility of ESD unintentionally triggering the stimulator.

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Safety Information Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-411

±1 kV differential mode

±1 kV differential mode*

±2 kV common mode

±2 kV common mode*

<5 % UT (>95 % dip in UT ) for 0.5 cycle

Complies at all line input voltages

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. High level surge disturbances may trigger stimulator error dialogue box. A mouse click is required to reset the dialogue box. This is an intentional error message so there is no possibility of surge disturbances unintentionally triggering the stimulator. Mains power quality should be that of a typical commercial or hospital environment. If the of the Cascade Elite requires continued operation during power mains interruptions, it is recommended that the Cascade Elite be powered from an uninterruptible power supply.

Complies at 240 V 50 Hz. Turns off at 120 V 60 Hz. Complies at all line input voltages Cascade Elite turns off. Restart of software required.

Power frequency (50/60 Hz) magnetic field

3A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Conducted RF IEC 61000-46

3 Vrms

V1 = 3 V

150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the Cascade Elite, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

E1 = 3 V/m

3 V/m Radiated RF IEC 61000-4-

80 MHz to 2.5 GHz 395

Elite Operators Manual 3

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol

Note 1 At 80 MHz and 800 MHz, the higher frequency applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Cascade Elite is used exceeds the applicable RF compliance level above, the Cascade Elite should be observed to normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Cascade Elite. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [v1] V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Cadwell Cascade Elite The Cascade Elite is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the of the Cascade Elite can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cascade Elite as recommended below, according to the maximum output power of the communications equipment

Rated maximum output power of transmitter

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Separation distance according to frequency of transmitter m

Safety Information W

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

d = 0.12 m

d = 0.12 m

d = 0.23 m

0.1

d = 0.38 m

d = 0.38 m

d = 0.73 m

1.0

d = 1.2 m

d = 1.2 m

d = 2.3 m

10

d = 3.8 m

d = 3.8 m

d = 7.3 m

100

d = 12 m

d = 12 m

d = 23 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3 Stated separation distances will assure safe operation of the Cascade Elite. However, some noise may present on displayed waveforms.

Disposal of Equipment At the end of product life, please take care to appropriately decontaminate the equipment before decommissioning or sending in to Cadwell for service or maintenance. Please dispose of equipment under the regulatory requirements of your country.

TCS Specifications Stimulus Output

TCS-1

TCS-1000

TCS-4

Maximum Voltage

800 volts

1000 volts

1000 volts

Maximum Current

1000 milliamps

1000 milliamps

1000 milliamps

Output Connectors

One pair, 1.5mm One pair, 1.5mm Four pair, 1.5mm fully shrouded fully shrouded fully shrouded "touch-proof" "touch-proof" "touch-proof"

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Elite Operators Manual inputs

inputs

inputs

50 or 75 microsecond fixed square wave

50 or 75 microsecond fixed square wave

Stimulus Pulse Train Parameters Pulse Width

50 microsecond fixed square wave

Maximum Repetition Rate

1 pulse train per 1 pulse train per 1 pulse train per second second second

Max # of Pulses per 9 Train

9

9

Minimum 1.0 ms Interstimulus Interval (rising edge to rising edge)

1.0 ms

1.0 ms

Selectable Parameters Output Voltage

0-800 Volts 0-1000 Volts 0-1000 Volts adjustable in 2- adjustable in 2- adjustable in 2volt increments volt increments volt increments via digital control via digital control via digital control

Interstimulus Interval

1.0-9.9 ms in 0.1 ms increments

1.0-9.9 ms in 0.1 ms increments

1.0-9.9 ms in 0.1 ms increments

Pulses Per Train

1-9

1-9

1-9

Output Polarity

Normal or Reversed

Normal or Reversed

Normal or Reversed

Indicators Power

Green LED lights Green LED lights Green LED lights when power ON. when power ON. when power ON.

Trigger/Polarity

Green LED lights Green LED lights Green LED lights when unit is when unit is when unit is triggered; triggered; triggered; indicates polarity indicates polarity indicates polarity by showing by showing by showing which output jack which output jack which output jack is the Anode (+). is the Anode (+). is the Anode (-).

Error

An error message An error message An error message is sent to the is sent to the is sent to the

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Safety Information controlling controlling controlling device2 when device2 when device2 when stimulus stimulus stimulus repetition rate or repetition rate or repetition rate or pulses per train pulses per train pulses per train exceed safe limits. exceed safe limits. exceed safe limits. Requested Voltage

The controls The controls The controls and observes the and observes the and observes the requested voltage requested voltage requested voltage from the from the from the controlling controlling controlling device. The device. The device. The controlling device controlling device controlling device sends requested sends requested sends requested voltage value to voltage value to voltage value to the TCS-1. the TCS-4. the TCS-1000.

Peak Delivered Current

TCS-1 reports delivered current (in milliamps) of the first pulse to controlling device.

TCS-1000 reports delivered current (in milliamps) of the first pulse to controlling device.

TCS-4 reports delivered current (in milliamps) of the first pulse to controlling device.

Safety Provisions Delivered stimulus voltage * time

Redundant Redundant Redundant hardware hardware hardware integrators inhibit integrators inhibit integrators inhibit the output when the output when the output when the voltage * the voltage * the voltage * stimulus time stimulus time stimulus time reaches the reaches the reaches the maximum maximum maximum allowed value. allowed value. allowed value.

Maximum Repetition Rate

The repetition The repetition The repetition rate is limited in rate is limited in rate is limited in hardware to no hardware to no hardware to no more than 1 pulse more than 1 pulse more than 1 pulse train per second. train per second. train per second. If more than one If more than one If more than one pulse train per pulse train per pulse train per second is second is second is

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Elite Operators Manual requested, an requested, an requested, an error is signaled error is signaled error is signaled and hardware and hardware and hardware prevents a trigger prevents a trigger prevents a trigger from being from being from being recognized for recognized for recognized for two seconds. two seconds. two seconds. Pulses per Train

A hardware A hardware A hardware circuit counts circuit counts circuit counts pulses per train pulses per train pulses per train and inhibits the and inhibits the and inhibits the output if more output if more output if more than 9 pulses are than 9 pulses are than 9 pulses are requested. If requested. If requested. If more than 9 are more than 9 are more than 9 are selected, an error selected, an error selected, an error is signaled and is signaled and is signaled and hardware hardware hardware prevents a trigger prevents a trigger prevents a trigger from being from being from being recognize for two recognize for two recognize for two seconds. seconds. seconds.

Minimum Interstimulus Interval

Hardware inhibits stimulus pulses that are requested at less than the approved minimum interstimulus interval.

Hardware inhibits stimulus pulses that are requested at less than the approved minimum interstimulus interval.

Hardware inhibits stimulus pulses that are requested at less than the approved minimum interstimulus interval.

Trigger Control External Trigger Input

Digital trigger Digital trigger Digital trigger signal sent from a signal sent from a signal sent from a controlling controlling controlling device. device. device.

Environmental Conditions Operating

400

5°C to 40°C (41°F 5°C to 40°C (41°F 5°C to 40°C (41°F to 104°F) @ 10% - to 104°F) @ 10% - to 104°F) @ 10% 90% RH non90% RH non90% RH non-

Safety Information condensing

condensing

condensing

-40°C to 60°C (40°F to 140°F) @ 10% - 90% RH non-condensing

-40°C to 60°C (40°F to 140°F) @ 10% - 90% RH non-condensing

-40°C to 60°C (40°F to 140°F) @ 10% - 90% RH non-condensing

Power

12 volts DC, 1 watt max. Supplied from Cadwell Cascade Elite base unit.

12 volts DC, 1 watt max. Supplied from Cadwell Cascade Elite base unit.

12 volts DC, 1 watt max. Supplied from Cadwell Cascade Elite base unit.

Mechanical

9.5"W x 6.25"D x1.9"H

9.5"W x 6.25"D x1.9"H

9.5"W x 6.25"D x1.9"H

Transport and Storage

Power Requirements

(24cmW x 16cmD (24cmW x 16cmD (24cmW x 16cmD x 5cmH) x 5cmH) x 5cmH) 1 lb. (0.45 kg)

1 lb. (0.45 kg)

1 lb. (0.45 kg)

I/O Connections Electrode

2 outputs (1 pair) 2 outputs (1 pair) 8 outputs (4 pair)

System Interconnect

1 Auxiliary cable 1 Auxiliary cable 1 Auxiliary cable

Safety/Regulatory Approvals UL 60601-1

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

CSA 601.1: 1990

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

CE 0344 XXXX

KEMA Medical

KEMA Medical

KEMA Medical

Notified Body

Notified Body

Notified Body

EN 60601-1: 2003

Medical electrical Medical electrical Medical electrical equipment - Part equipment - Part equipment - Part 1: General 1: General 1: General

401

Elite Operators Manual requirements for requirements for requirements for safety safety safety EN 60601-1-1: 1993

Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Medical electrical Medical electrical equipment - Part equipment - Part 1: General 1: General requirements for requirements for safety - Collateral safety - Collateral standard: Safety standard: Safety requirements for requirements for medical electrical medical electrical systems systems

EN 60601-1-2: 2001

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatability Requirements and tests.

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatability Requirements and tests.

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatability Requirements and tests.

EN 60601-2-40: 1998 Medical electrical Medical electrical Medical electrical equipment - Part equipment - Part equipment - Part 2-40: Particular 2-40: Particular 2-40: Particular requirements for requirements for requirements for the safety of the safety of the safety of electromyographs electromyographs electromyographs and evoked and evoked and evoked response response response equipment. equipment. equipment. EN 60601--4: 1996

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems.

Medical electrical Medical electrical equipment - Part equipment - Part 1-4: General 1-4: General requirements for requirements for safety - Collateral safety - Collateral standard: standard: Programmable Programmable electrical medical electrical medical systems. systems.

The controlling device is connected to the TCS-1/TCS-1000/TCS-4 via a 402

Safety Information custom serial port, which offers two-way communications and a dedicated trigger wire. This controlling device is typically a Cadwell Cascade Surgical Monitoring System. Parameters and triggers are sent from the controlling device to the TCS-1/TCS-1000/TCS-4. Status and error messages are sent from the TCS-1/TCS-1000/TCS-4 to the controlling device.

ES-IX Specifications

Operating Mode

Minimum Maximum Maximum Intensity Current Voltage Increment

100 mA CC 100 mA

400 V

0.5 mA

Reprate 0-67 Hz

Multipulse Reprate (max 10 pulses)

Pulse Width

100 - 2000 Hz

50-1000 us

20 mA CC

20 mA

100 V

0.1 mA

0-67 Hz

100 - 2000 Hz

50-1000 us

5 mA CC

5 mA

60 V

0.01 mA

0-67 Hz

100 - 2000 Hz

50-1000 us

100 - 2000 Hz

50-1000 us

20 V CV 5 V CV

35 mA 15 mA

20 V 5V

0.1 V 0.01 V

0-67 Hz 0-67 Hz

100 - 2000 Hz

50-1000 us

The ES-IX can be configured through software to deliver either monophasic or biphasic symmetric stimulation waveforms on all outputs and in all operating modes. Running the ES-IX stimulator with monophasic stimulation waveforms will result in a net DC current.

Electrode Current Density Graphs EMG Needle

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Elite Operators Manual

EEG Needle

Disposable Bar Electrodes 404

Safety Information

Bar Electrodes

Felt-Pad Bar Electrodes 405

Elite Operators Manual

Electrical Stimulator Characteristics

406

Safety Information

ES-IX Stimulator Characteristics

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Elite Operators Manual

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Safety Information

409

Elite Operators Manual

410

Safety Information

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Care and Cleaning of Equipment General Cleaning Turn off and disconnect all Cascade components before cleaning. Do not attempt to service or repair damaged or inoperable equipment. The Cascade Elite is designed to be water resistant. To maintain water resistance, do not remove or loosen the Cascade Elite's connector screws. Perform cleaning and sterilization procedures on a periodic basis to ensure the safe operation of your Cascade system. As you clean, visually inspect the instrument and its components for damage or wear. Cadwell if you notice damage to the exterior of the instrument. See Cascade Customer for more information. Cadwell recommends that you refer to the AAMI Standards and Recommended Practices for Sterilization, Volume 1: Good Hospital Practices, and Volume 2: Hospital Equipment and Industrial Process Control or equivalent standard text for detailed sterilization instructions. These texts may be ordered by calling the Association for Advancement of Medical Instrumentation at 1-800-332-2264, ext. 217 in the U.S.

Cleaning Cascade Components Disconnect the base unit, stimulators, and AC Power before cleaning. Keep all cleaning fluids away from electrical connectors. Do not let solutions seep inside the base unit, stimulators, recording electrode inputs or power/com module. Do not use abrasive cleansers. If sterile electrode packaging is damaged, do not use the electrode. Discard according to hospital standard operating procedure for sharps disposal.

Cleaning Components To clean components, use a soft cloth to wipe away any dust that has collected on the instrument casing. Use a dry cloth or one that is slightly dampened in a mild soap-andwater solution or ammonium based surface disinfectant such as Envirocide® (active ingredients - Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28% Isopropanol 17.20%). Isopropyl Alcohol may also be used to clean the exterior of the unit. A soft brush or pressurized air duster can also be used to remove dust from hard-toaccess areas, such as between connectors on the connector . To clean dust from the printer or the monitor’s screen, wipe it with a soft cloth.

Cleaning Stimulators Turn off and disconnect stimulators before cleaning. Keep all cleaning fluids away from electrical connectors. Do not let solutions seep inside the stimulators. Do not use abrasive cleansers. 413

Elite Operators Manual The ES-IX meets IP64 standard for drip proof equipment; however, the Electrical Stim Splitter family does not.

Cleaning Stimulators Visually inspect each stimulator for unusual wear or damage prior to each use. If you notice damage, disconnect the stimulator immediately, and Cadwell. See Cascade Customer for information. Use a soft cloth to clean stimulator parts that come in with the patient after each use (e.g., electrical stimulator probes, earphones, and LED goggles). Properly dispose of the foam tips used with the insert earphones after each use. The cloth may be slightly dampened in a mild soap-and-water solution or ammonium based surface disinfectant such as Envirocide® (active ingredients - Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28% Isopropanol 17.20%). Isopropyl Alcohol may also be used to clean the exterior of the unit. Visually inspect the interface cables and power cords that are used with components, stimulators, and accessories. If you notice unusual wear or breakage, disconnect the cable or cord immediately, and Cadwell for replacement.

Cleaning Electrodes The quality of signal acquisition is affected by the condition of your recording electrodes. Routine inspection, careful handling, frequent cleaning, and proper storage are essential practices for properly maintaining them.

Maintaining non-specialized electrodes 1. Inspect electrode leads for breaks, rust, corrosion, and debris prior to use. 2. Handle electrodes carefully, and do not pull on the leads. 3. Clean electrodes in warm water, using a toothbrush to scrub the surface of the electrode. If necessary, soak electrodes to loosen debris. (Using a file or steel wool to scrub electrodes may lead to contamination of electrode metal. This can result in signal artifact.) 4. For proper sterilization techniques, refer to the electrode manufacturer's instructions. 5. If necessary, dry electrodes thoroughly to prevent corrosion from hard water deposits. 6. Store electrodes in a clean, dry place. 7. Do not tangle or kink electrode leads. 8. Properly discard disposable electrodes after each use (e.g., disposable needle electrodes and disposable surface electrodes). 9. Never attempt to use an electrode with damaged packaging or if sterility may have been compromised. 414

Care and Cleaning of Equipment NOTE: Specialized electrodes are often more complex and require special care. Anyone using them should consult the electrode manufacturer for proper maintenance and handling techniques.

Examples of specialized electrodes: •

EEG Grid Electrodes - for direct placement on the exposed cortex of the brain

•

Micro-electrodes - for pallidotomy and thalamotomy procedures

•

St. Mark's Pudendal Electrode

•

Nasopharyngeal Electrodes

•

Piezo-electric Thermocouples, Airflow Sensors, Movement Sensors

•

Cotton-wick Electrodes - for direct placement on nerves

General Care of TCS Units TCS stimulators should be stored in a clean, dry place. Handle the system with care. TCS stimulators are not waterproof, splash proof or dirt proof.

Factory Calibration, Preventive Inspection, Maintenance The TCS system is calibrated at Cadwell. No additional hardware calibration is needed. Inspect all cables before and after each use. Discard cables if insulation is damaged or if the cable or connectors are damaged in any manner. the Cadwell Service department if any errors are reported using the TCS system.

415

Service and Maintenance Amplifier Calibration When this is selected a window will be displayed containing all 16 amplifier channels. Clicking on the Run button will input a calibration signal in all of the channels. The calibration signal is 100 uV peak to peak and is presented at a frequency of 100 Hz. Checking the overlay traces box will superimpose all the traces on top of each other.

Amplifier Calibration window.

You can right-click on the calibration window to add time or amplitude markers and to print a report that contains the calibration signals. When printing a report, select the Calibration template.

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Elite Operators Manual

To close the Calibration window, click on the X in the upper right hand corner.

Amplifier Diagnostics

When this is selected the following amplifier diagnostics window will be displayed.

Several different types of amplifier diagnostic tests can be run from this window. The type of test is selected from the pull-down menu in the upper left hand corner. Once the type of test has been selected, click on the Run button to perform the test. To view the results of the test, click on the Report button.

Test Types: Gain: a 100 Hz sine wave is run through the three amplifier gain stages of 100, 1000, and 10,000 uV/div. The peak to peak amplitude of the signal is taken from 10 different sweeps and averaged. The resulting amplitude must be within +/- 10% in order to . Locut: a sine wave is run through the four amplifier hardware locut filters, these are 0.5, 10, 30, and 100 Hz. The test checks to see that the amplitude of the calibration signal is 50% reduced at the filter frequency. The peak to peak amplitude of the signal is taken from 10 different sweeps at each locut 418

Service and Maintenance setting and is averaged. The amplitude of the signal must be within +/15% in order to . Hicut: a sine wave is run through the 5000 Hz hicut filter setting. The test checks to see that the amplitude of the calibration is 50% reduced at the filter frequency. The peak to peak amplitude of the signal is taken from 10 different sweeps and is averaged. The amplitude of the signal must be within +/- 30% in order to . Noise: in this test all active and reference inputs are connected internally to ground and the maximum peak to peak amplitude of the noise over several sweeps is calculated. This is a two part test with measurements being taken in both EMG and an EP modes. The noise level in each channel should be less than 5 uV in order to . Impedance: a special impedance array is used for this test. This array is plugged into each extender pod input and the values are checked against known inputs. A different resistence value is used for each pod input. As each row is checked the impedance values for the inputs in that row are displayed and are colored green when they the test. Please see Impedance Test Arrays for more detailed information. Montage: a calibration signal is ed through several different montage types to test the input switching capability of the amplifier. Four hard coded montages are always tested and the can add other montages to the test list by clicking on the Add Montage button. If the appropriate calibration signal is measured in each channel the channel es the test. ALL: When this is selected the program performs the Gain, Locut, Hicut, and Noise tests in sequence.

Reports: Clicking on the Reports button will display the reports table.

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Elite Operators Manual

Amplifier Diagnostics Report window

The results for the Gain, Locut, Hicut, and Noise tests are listed on the first tab. The repeat count indicates how many times the test was run and the number listed for each channel indicates how many times that channel ed the test. A reading of –1 indicates the test was not performed. A reading in the channel columns less than the repeat count indicates that the amp failed the test at least once. The Impedance tab shows the results for the impedance test, the Montage tab shows the results of the montage test. You can click on the Print Report button to generate a report with all the diagnostic test results included. Use the Diagnostics template for this report. To close the Diagnostics window, click on the X in the upper right hand corner.

Impedance Test Arrays & Amplifier Diagnostics Impedance Test Arrays are devices with known impedances that can be plugged into amplifiers to test or proper impedance function. They can also be used to troubleshoot hardware for continuity of connection issues. To test amplifier impedances: 1. From the Cascade Elite Start Page, click Amplifier Diagnostic.

2. Select Impedance from the drop-down menu.

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Service and Maintenance

3. Plug one Impedance Test Array into each extender pod input on the connector of the amplifier, then click OK on the Test Editor pop-up screen.

4. As the impedance of each row is checked, the impedance values for the inputs in that row are displayed and are colored green when they the test. The test uses a different impedance value on each pod input.

•

Impedance ranges are as follows:

5. After testing all inputs, click Done in the bottom of the Impedance window. From the Amp Diagnostic window, you can view and print a diagnostic report

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Elite Operators Manual by clicking Report, then selecting the Impedance tab on the Diagnostic Report window.

6. Click OK to exit the Diagnostic Report. 7. Click the red X to exit Amp Diagnostic.

ES-IX Diagnostics Included in the Amp Diagnostics routines are the ES-IX Diagnostics.

When ES-IX Diagnostic is selected from the Amp Diagnostics dropdown, the following menu appears:

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Service and Maintenance

Standard tests for the ES-IX are the Level 2 & 3 self tests. Level 2 Self Test is initiated by simply pressing the Level 2 Self Test button. Level 3 Self Test is initiated by simply pressing the Level 3 Self Test button. Level 3 self test requires the use of the ES-IX Test Array (190268-200), which should have shipped with your ES-IX. Plug the test array into the ES-IX when prompted to apply the 3.48 kOhm test load by the software. The results of all tests are shown in the bottom , and the results summary is included in the middle . ES-IX Diagnostic results are not included in the Amp Diagnostics reports. Rather, they are stored in C:\Cadwell\Cascade\Logs. A report log is written to this directory every

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Elite Operators Manual time an ES-IX Diagnostic test is performed. The files are designated with the "ES-IX Test Log" file prefix. The Leakage test is initiated by simply pressing the Leakage Test button. This test requires the ES-IX Test Array and a multimeter. The DC voltage across each output must be measured manually using a multimeter.

Routine Maintenance Backup of patient data Establish a regular routine for backing up Cascade patient data. Back up onto media that has enough storage space to contain the data, such as CDs or Zip disks. (There is not enough space on a floppy disk.) 1. Locate the folder C:\Cadwell\Cascade\PatientData. This is the default directory. This folder is where patient data is stored and can be moved or renamed. 2. Copy the procedure data files to the backup media. (The procedure data files end with the .smd extension.) Please see Archiving with Windows 7 CDR/DVDR burner for more information.

Remove laptop computer 1. Press the power switch on the front of the instrument base to the off position. 2. Press the laptop power switch to off. 3. Close the laptop. 4. Remove the PCMCIA card by pushing on the release button. Pull the card completely out of the slot. 5. Disconnect all cables from the back of the laptop. 6. Gently lift the laptop off the instrument base.

Laptop battery Refer to laptop computer manufacturer’s instructions for information on battery use and care.

Archiving with Windows 7 built-in burner 1. Browse to the C:\Cadwell\Cascade\PatientData folder. 2. Right click on a data file to be put on disc and select Send To. Then Select the CD drive.

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3. Insert a blank CDR or DVDR disc into the drive when prompted. You can write to a CD more than once.

4. Insert a blank CD-R into the CD-R drive. Select "With a CD/DVD player..

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5. Notice the balloon by the system tray indicating you have files waiting to be burned to disc. Click in the balloon or open Computer and select the CD drive.

6. Click the Burn to Disc button.

7. Click Next.

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8. The files will be written to the disc. The disc will eject when complete. Click Finish.

Repair Recommended Factory Service Interval

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Elite Operators Manual In general, Cadwell recommends yearly factory service and calibration verification to help assure continued top performance from the equipment. However, the service interval may be lengthened or shortened as device performance history dictates. Refer to your facility’s in-house equipment calibration policies and procedures for further guidance on this subject.

Field service information This information will be made available to qualified personnel. There is a charge for documents and a non-disclosure agreement must be signed. Cadwell Service department for details. See Cascade Customer for more information.

Software Upgrades Upgrade the software on your Cadwell Cascade is easy and reliable. Upgrading software will not cause you to loose patient data or procedure files. Only the software changes. When software upgrades for your Cadwell Cascade are available, simply follow the installation instructions. There are typically two parts to a software upgrade: upgrading the software and upgrading the firmware. A firmware upgrade requires that you cycle the power on your base unit. When upgrading software and firmware from CD, you will be reminded to cycle the power on the base unit after installing the new firmware. This step is required in order for the new software to run properly.

If somehow the firmware and the software get out of match, the Cascade system will alert you and allow you to choose to have the DSP firmware updated automatically. After automatically updating the firmware, the system will remind you to turn off the base unit as described above.

NOTE: Cascade s with the optional trigger-in hardware modification to the base (DTS192-200) should always manually install the DSP firmware from the CD. DTS192200 s should not choose the automatic firmware update mentioned above nor the automatic firmware installation option when installing from CD.

Third Party Applications

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Service and Maintenance It is not recommended to install any and every third party application you desire to use on your Cadwell Cascade system. The Cascade is a medical device that is ran on a computer. Third party applications can cause undesirable results with medical equipment such as Cascade. It is impossible for medical equipment manufactures to tests every possible combination of software that might be loaded onto a device. Only install applications that are absolutely necessary on your Cadwell Cascade systems.

Warranty & Service Contracts Limited Warranty Cadwell warrants for a period of one year from the date of purchase, the system listed against defects in material and workmanship. Notice of a defect and an explanation of circumstances concerning any claim that the system has proven defective in material or workmanship shall be given to Cadwell within two (2) working days of the discovery of the defect in the system. Upon such notice, Cadwell will follow the company service procedures outlined on page 1 (of the warranty). Cadwell agrees to retrofit equipment. If the company makes standard improvements to components of the equipment covered under this agreement during the term of the warranty and if such improvements are compatible with the equipment located on the customer’s premises, then Cadwell will retrofit such physical equipment at no additional charge. Cadwell reserves the right to make changes in specifications, construction or design of its products at any time in such a manner as it may consider necessary or advisable.

Preventative Maintenance When equipment is delivered at customer’s expense during the term of the warranty to Cadwell, Cadwell will take the action necessary to insure performance to specifications, including cleaning as necessary, checking, calibrating, and ing operation. Preventative maintenance must be scheduled with Cadwell.

Warranty Exclusion •

Except as expressly set forth herein, there is no warranty, expressed or implied as to fitness for any particular purpose, nor to anything else unless contained on the face of this Agreement. All other warranties, expressed or implied, including, but not limited to, any IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR USE, ARE HEREBY DISCLAIMED.

•

Cadwell shall be under no obligation to furnish, repair or replace any part which has been damaged, abused or misused through no fault of Cadwell, or if unauthorized attempts to modify, repair or service equipment have impaired the performance of the equipment.

Oral Statements Do Not Constitute Warranties

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Elite Operators Manual Representatives of Cadwell are not authorized to make warranties about the merchandise described in this Agreement. These representatives’ ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES, shall not be relied upon by the customer and are not part of the contract. The entire contract is embodied in this writing and NO OTHER WARRANTIES are given beyond those set forth in this contract. This writing constitutes the final expression of the parties’ agreement, and it is a complete and exclusive statement of the of that agreement.

Sole Purpose The sole purpose of the exclusive remedy shall be to provide the customer with free repair and/or replacement of defective parts in the manner provided herein. This exclusive remedy shall not be deemed to have failed of its essential purpose so long as the company is willing to repair or replace defective parts in the prescribed manner.

Indemnification Customer agrees to indemnify Cadwell and hold it harmless from any and all demands or claims of any nature whatsoever arising out of the use of the equipment, including product liability or physical injuries to person or property, loss of life, or other claims or damages.

Business Use Except as expressly provided by Cadwell in writing, all goods sold hereunder are intended for the ultimate use by a commercial and for operation by persons trained and experienced in the use and maintenance of such equipment. Cadwell’s warranty does not extend to any consumer. Customer acknowledges that it is purchasing the equipment for a business use and for no other.

Exclusive Remedy and Limitations of Damages The parties agree that the customer’s SOLE AND EXCLUSIVE REMEDY against Cadwell shall be for repair and/or replacement of defective parts as provided herein. Customer agrees that NO OTHER REMEDY SHALL BE AVAILABLE to them and that the company shall not, in any event, be liable for incidental damages or consequential damages, including loss of income, loss of time, lost sales, injury to person or personal property, liability customer had with respect to any other person, or for any other type of formal consequential damage or economic loss.

Severability If any provision or clause of this Contract or the application thereof to any person or circumstance is held invalid or unconscionable, such invalidity or unconscionability shall not affect other provisions or applications of the Contract which can be given without the invalid or unconscionable provision or application, and to this end the provisions of this Contract are declared to be severable.

Cost of Legal Action 430

Service and Maintenance In the event any action shall be instituted for the failure to perform the and conditions of this Agreement, the prevailing party shall be entitled to recover costs, including attorney’s fees.

Time Limit on Customer Commencing Legal Actions An action by the customer for breach of this Agreement or any other action by customer otherwise arising out of this transaction must be commenced within one year from the date the right, claim, demand or cause of action shall first accrue, or be barred forever.

No Waiver If Cadwell at its option agrees to a waiver of any of the and conditions recited herein, such waiver shall not for any purpose be construed as a waiver of any succeeding breach of the same or any other or conditions of this Agreement; nor shall such a waiver be viewed as a course of performance. CUSTOMER AGREES TO BE BOUND BY ALL OF THE ABOVE AND FURTHER AGREES THAT THEY CONSTITUTE THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN THEM WHICH SUPERSEDES ALL PROPOSALS, ORAL OR WRITTEN AND ALL OTHER COMMUNICATIONS BETWEEN THEM RELATING TO THE SYSTEM AND WARRANTY THEREON. THIS AGREEMENT WILL BE GOVERNED BY THE STATE OF WASHINGTON AND SHALL NOT BE MODIFIED, AMENDED OR OTHERWISE AFFECTED EXCEPT BY A WRITING SIGNED BY BOTH PARTIES.

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Customer Using Help Files By accessing the Cascade Help files you can get the same information about the operation, terminology, and capabilities of the Cascade Elite as are found in the Operator's Manual. The Help files can be accessed during operation of the Cascade Elite software. From the Help pull-down menu, select Cascade Elite Help Topics. An electronic copy of the Operator's Manual is available on the software installation CD included with your Cascade Elite system. To access the file, insert the CD into the CD reader on your computer. An installation menu should appear. Click Explore CD. Open the Documents folder and select Cascade Elite Help File. If the installation menu does not appear after inserting the CD, open Windows Explorer, right click on the CD icon, choose Explore and double click the Cascade Elite Help File icon.

Cascade Customer Information www.cadwell.com Domestic customers:

Phone:

800-245-3001 or 509-735-6481

Fax:

509-783-6503

International customers:

Please your distributor (listings available at www.cadwell.com) or email

hours Service department : Monday through Friday from 6:30 am to 5 pm PST Application : Monday through Friday from 6:30 am to 5 pm PST, Early am OR starts at 4 am PST

When to Cascade Customer customer if: •

You continue to experience difficulty after troubleshooting a problem. Cadwell has a rapid, cost-effective method for troubleshooting and servicing equipment. Most problems can be diagnosed over the telephone, and repairs can be performed by sending in the defective part.

•

You wish to order optional equipment.

To Cadwell for a problem

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Elite Operators Manual 1. Have your customer identification number and serial number near the phone. Have a person who runs the equipment be prepared to speak to a service technician. This person should be able to provide an accurate description of the problem. It is best if the person calling is in front of the equipment when they call. 2. Call the customer number, and ask for the service department. The Cadwell service technician will determine if an exchange or repair of parts is necessary and instruct you on appropriate shipping arrangements.

Remote Assistance Application The Application Department is professionally staffed to help you through specific application-related issues pertaining to your Cadwell equipment. Phone is provided free-of-charge for the life of your instrument.

Service For Service related help with Cadwell instruments, you can Cadwell's staff of professionally trained service technicians. Phone is provided free-of-charge for the life of your instrument.

Remote Assistance Remote assistance and troubleshooting is available for systems under warranty or service contract. With your permission, a technician can establish a secure connection to your Cadwell instrument via the internet. Please call the service department or application department at the phone numbers listed in Cascade Customer . A or service technician will your information and guide you through the steps to begin a remote assistance session.

Shipping Equipment Federal Express is the authorized shipping agent for returning equipment to Cadwell. Cascade Customer if you have questions about packing and shipping equipment.

To return equipment 1. Place the item in the original shipping box or other appropriate shipping container. 2. Write the Return Merchandise Authorization (RMA) number on the left corner of the box. The RMA number is on the shipping paperwork you received with the new part, as well as on the Federal Express air bill.

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Customer 3. Complete the return address information (section 1) on the air bill. Keep all copies together. 4. Call Federal Express to arrange for pickup. 5. Use the plastic pouch that the Federal Express driver gives you to enclose the air bill form, and attach it to the sealed box. Be sure to note the Federal Express air bill number for your records.

Exchanging and returning parts for repair Most problems can be diagnosed over the telephone. Those that cannot may require that you ship the defective part to Cadwell for service or repair. Repairs are usually made by sending an exchange/repair part. Every effort is made to ship the part the same day the problem is identified. Parts are sent by second-day air service. Overnight and Saturday services are available for an additional charge. If you are returning any item for repair, Cadwell issues a return merchandise authorization (RMA) number. Refer to this number when requesting information about the repair.

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Approvals and Standards Compliances Domestic and International Approvals Cascade, Cascade Elite, and Cascade PRO are cleared for use by the FDA. Cascade, Cascade Elite, and Cascade PRO are Health Canada approved. Cascade and Cascade Elite are EU/CE approved.

Cascade Elite meets the following internationally recognized safety standards for Medical Electrical Equipment: IEC 60601-1 : General Requirement for Safety IEC 60601-1-1 / EN60601-1-1 : Collateral Standard – Safety requirements for medical electrical systems IEC 60601-1-2 / EN60601-1-2 : Collateral Standard – Electromagnetic compatibility IEC 60601-1-4 : Collateral Standard – Programmable electrical medical systems IEC 60601-2-40 : Particular requirements for the safety of electromyographs and evoked response equipment. UL 60601-1 : General Requirement for Safety CSA 601-1 : General Requirement for Safety Regulatory Classification Information United States: Class II Canada: Class II European Union: Class IIB (annexes III & V) Type of Protection Against Electric Shock Class I Equipment (with Safety Ground) Degree of Protection Against Electric Shock Type BF Equipment (Floating Inputs)

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Elite Operators Manual Degree of Protection Against Ingress of Solids and Liquids IP 65 (Dust and splash resistant) ES-IX Stimulator meets IP 64 (Dripproof) Mode of Operation Continuous European Legal Entity CEpartner4U, Esdoornlaan 13 3951 DB Maarn The Netherlands Tel: +31 6 516 536 26 URL: www.cepartner4u.nl

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Frequently Asked Questions Some Frequently Asked Questions: 1. How to change the display gain of traces in the EP Average window.  To change the display gain of all traces at once: •

Click on the EP Average window with the left mouse button. The window will be activated and its corresponding toolbar will be displayed at the top of the screen. In the toolbar, click the up/down arrows next to the display gain field to change all the displayed traces.

 To change the display gain of only a selected Trial or Trace: •

Click on the desired trial or trace with the left mouse button. The selected trial or trace will be displayed in yellow. You can change the display gain by two methods, 1) turn the wheel on the mouse, or 2) click the up/down arrows keys in the EP Average window toolbar. After you have changed the display gain, click on the selected trial or trace a second time to de-select it (yellow color is removed).

2. How to change the Setup of the Waterfall, 3D Trend, Cursor Trend or Event windows (i.e., change the trend time, display gain, turn Off/On labels). •

Move the mouse over the window you want to change. Click the right mouse button. From the pop-up menu, select Setup. The window’s setup menu will be displayed. Make the appropriate changes and click OK.

3. How to Save Parameter Changes that were made during acquisition as the new default parameters for the procedure. •

From the File pull-down menu, select Save Current Setup.

4. How to change Filter settings or Amplifier Inputs for a channel during a procedure. •

From the Edit pull-down menu, select Edit Current Procedure Setup. The Procedure Setup window is displayed. Make the appropriate changes to the filter settings or amplifier inputs. Click OK to return to the acquisition mode. **Entering Procedure Setup will stop all data acquisition, you will need to restart your acquisition modes after clicking OK.**

5. How to Add or Delete a Window from a View during a procedure. •

From the Edit pull-down menu, select Edit Current Procedure Setup. The Procedure Setup window is displayed. Move to the View area in the lower left-hand corner of this window. Click on the tab corresponding to the View you want to change. The available windows are listed with a check box next 439

Elite Operators Manual to each one. The windows that are currently enabled for this View will have a check mark next to them. To add a window to this View, simply click on the check box next to the window that you want to add. To remove a window from this View, click on the check box and remove the check mark next to the window you want to remove. Click OK to return to the acquisition mode. NOTE: If you added a new window to a View you will need to position and size the window to your liking. Initially new windows are just floating in the middle of the View.

6. How to perform Stimulated (Triggered) EMG. •

First, create an acquisition mode in your procedure setup and select EMG for the mode type. Then, for the Stim Type, select Electrical. Use the Stim Setup window to select the electrical stimulator output number, the repetition rate, and pulse duration. Next, assign the appropriate channels to the EMG mode.

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During the procedure, use the buttons in the EMG Mode Controls area to start & stop the live EMG, stimulate repetitively, stimulate and hold the trace, perform a single stimulation, and to adjust the electrical stimulator intensity.

7. How to display both Live EMG and Stimulated (Triggered) EMG windows at the same time during acquisition. •

In the Procedure Setup file, create two identical EMG modes (identical means that they have the same amplifier channels assigned to them). For the Live EMG mode, do not select a Stim Type, leave this as None. For the Triggered EMG mode, select Electrical as the Stim Type, and then program the stimulator number, repetition rate, and pulse duration. You can have different sweep speeds for the two modes, however, the gain setting must be the same in each mode.

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During the procedure you will have separate controls for each EMG mode. The Live EMG mode will only have a Run/Stop control. The Triggered EMG mode will have Run/Stop, Repetitive stim, Single Stim, Hold, and a stimulus intensity knob. Start both modes running, when you are ready to stimulate check the Hold box for the Triggered EMG mode.

8. What does the RR Warning label indicate in the EP Mode Control area. •

If the Cascade cannot deliver the requested repetition rate for a mode, the Repetition Rate warning symbol will be displayed. The actual repetition rate that the system is delivering to the patient is displayed next to the warning symbol. In order to remove the RR warning, you may need to adjust the repetition rates or sweep speeds of other acquisition modes.

9. How to move auto-cursors on a trace. •

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Simply move the mouse over the cursor of interest then click the left mouse button and drag the cursor to its new position. All windows that display this trace will display the new cursor position.

Frequently Asked Questions

10. How to insert latency or amplitude markers in a window. •

Latency Marker – move the mouse over the window of interest and click the right mouse button. From the pop-up menu select Add Time Marker. A vertical time marker will be inserted into the window. To move the time marker, position the mouse over the marker then click the left mouse button and drag the marker to where you want it. The latency of the marker is displayed at the top of the window, (Time1 = x msec). If you need more than one latency marker, right click the mouse and select Add Time Marker a second time. The second latency marker is designated as Time2. The difference between the two latency markers is also displayed.

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Amplitude Marker – move the mouse over the window of interest and click the right mouse button. From the pop-up menu select Amplitude Markers. Two horizontal markers will be inserted into the window. To move the markers, position the mouse over a marker then click the left mouse button and drag the marker to where you want it. The amplitude is measured between the two markers and is displayed at the top of the window.

11. How to remove Latency or Amplitude markers from a window. •

For latency markers, drag the markers off the left edge of the window. For amplitude markers, drag one of the markers off the top edge of the window.

12. How to pick a Baseline Trial/Trace. •

Select the appropriate trial/trace by clicking on it with the left mouse button. When selected, the trial/trace is displayed in a “yellow” color. Now, click the right mouse button and select Set Baseline from the pop-up menu. A copy of the selected trial/trace is positioned below the active channels and are displayed in a “blue” color. The baseline trial/trace will remain in the window until a new baseline is selected or a channel is removed from the window setup.

13. How to change the Gain or Sweep of an EMG window during a procedure. •

Gain – right click the mouse over the EMG window. From the pop-up menu select Mode Setup. The EMG Mode Setup window will be displayed. The gain can be changed individually or for all channels at once. To change the gain of one channel, select the channel by clicking on it with the left mouse. Now click and drag the Gain Knob to the desired setting. To change the gain of all channels at once, select all the channels by clicking with the left mouse and dragging the mouse over the top of all the channels. All the channels will be selected. Now, click and drag the Gain Knob to the desired setting. Click OK.

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Sweep – right click the mouse over the EMG window. From the pop-up menu select Mode Setup. The EMG Mode Setup window will be displayed. Simply click and drag the Sweep Knob to the desired setting. Click OK.

14. How to change the Setup of an EP Average Window during a procedure (i.e., turn off the cursors, turn off the trace labels, change the stored trace count, remove a channel). •

Position the mouse over the EP Average window and click the right mouse button. From the pop-up menu, select Setup. The EP Average Setup window is displayed. Make the appropriate changes to the settings in this window and then click OK.

15. How to check electrode impedances. •

Click on the Z toolbar button at the top of the display. The Impedance window will be displayed showing the measured impedance of all amplifier inputs. Click Done to close the impedance window and continue the procedure.

16. How to reposition traces in the EP Average Window. •

Positioning a Trial – to move all the traces in one trial, click the left mouse button over one of the traces in the trial. All the traces in that trial will be colored “yellow”. Now, click the left mouse button and drag the trial to its new location and then release the left mouse button. Click the left mouse button on one of the traces in the trial again to de-select the trial.

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Positioning an individual Trace – right click the mouse and select Trial Select from the pop-up menu. This will turn Off the Trial Select mode (i.e., removes the check mark). Now, click the left mouse button on the trace you want to move, the selected trace will be displayed in “yellow”. Click the left mouse button on the selected trace and drag the trace to its new location. Click the left mouse button on the trace again to de-select the trace. To return the window to the default Trial Select mode, right click the mouse and then click on Trial Select in the pop-up window.

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Positioning all Traces at once – if you move one of the Active traces (colored “white” on the screen) the system will also move all the stored traces that go with it. You will notice that each time an active trace is moved the Cascade applies an auto-positioning routine to keep the traces separated adequately on the screen.

17. How to change the Repetition Rate of a mode during a procedure. •

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Move the mouse over the EP Average window or Stimulated EMG window of interest. Click the right mouse button. From the pop-up menu, select Mode Setup. Change the repetition rate and then click OK.

Frequently Asked Questions

18. How to view LIVE non-averaged data in an EP Average Window. •

Move the mouse over the EP Average window of interest and click the left mouse button anywhere within this window. This ensures that the window is selected. Now, click on the AVG button in the toolbar at the top of the display. You will notice the while this button is pushed-in the word LIVE is displayed on the button. This means that the window is displaying the nonaveraged data for each channel. To return to viewing the running average, click on the LIVE button and it will return to the AVG mode.

19. How to Copy and Paste a Cascade window into another Windows Application •

Move the mouse over the window of interest and click the right mouse button. Select Copy from the pop-up menu. Now, go the Windows Start button and start the application you are going to paste the copied window into (i.e., Word, Paint). Once the application is ready, select Paste from the Edit pull-down menu.

20. How to interleave multiple acquisition modes. •

The Cascade automatically interleaves all running acquisition modes that have an assigned stimulus type. The doesn’t need to make any special parameter selections. For example, if you have two SEP modes they are automatically interleaved as soon as both modes are started.

21. How to adjust the electrical stimulus intensity in fine increments. •

To increase the stimulus intensity - click the left mouse button on the righthalf of the stimulus intensity knob. The intensity should increment by one step. To decrease the stimulus intensity - click the left mouse button on the left-half of the stimulus intensity knob. The intensity should decrease by one step. The size of the steps will vary and is directly related to the maximum intensity level of stimulator.

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You can also use the Page Up/Page Down keys to change the setting in 1.0 mA increments. The Left/Right Arrow keys can be used to change the setting in 0.1 mA increments.

22. How to make a copy of a window. For example, you might want two waterfall windows for a particular acquisition mode so that you can stack two different channels at the same time. For example, have one waterfall of the cortical potentials and the other waterfall with the subcortical potentials. •

In the View area of the Procedure Setup window, highlight the window you want to make a copy of by clicking on it. For example, highlight the Rt. Median Waterfall window. Click on the Insert Copy button. There will now be two Rt. Median Waterfall windows in the list. 443

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Use the Rename Window button to give each window a unique name, for instance Rt Median Cortical and Rt. Median Sub-Cortical. Use the Window Setup button to configure the default parameters for each window, including the trace that each window will be stacking.

23. How to create Multiple Test Montages. This would be necessary when the DSP utilization is exceeded because there are too many active Modes in one Test. By creating a second Test (or sub-test) you can assign some of the Modes to the first Test and the rest of the Modes to the second Test. •

Right click anywhere over the Test area in the Procedure Setup window. Select Add from the pop-up menu. The Create New Test window is displayed. Enter a name for the Test, you can also use the check boxes to Copy the Channels and Channel Names from the first Test montage.

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In the Active Modes area, below the Test montage, select the acquisition Modes that you want to assign to each Test. While running the procedure, use the Test pull-down menu to ‘switch’ from one Test to another. When you change Tests the corresponding mode controls assigned to that Test, will be enabled in the Mode Controls window.

24. Where are the Patient Data Files stored? •

The Cascade data files are stored in the location specified in the System Setup window. The System Setup window can be displayed by selecting System Setup from the Edit pull-down menu.

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The default location is C:\Cadwell\Cascade\Patient Data.

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You should periodically Copy or Archive the patient data files to an appropriate backup media.

NOTE: The Procedure Setup files, Event files, Cursor Table files, Amplifier Input files, and Report Templates are also stored in the Data folder. Be careful not to move or delete these files from the folder.

25. How to Copy Procedure Setup Files.

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The Cascade Procedure Setup files are stored in the location specified in the System Setup window. The System Setup window can be displayed by selecting System Setup from the Edit pull-down menu.

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The default location is C:\Cadwell\Cascade\Setup Files.

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Use Windows Explorer to navigate to the folder mentioned above. Once you are there, use the Copy and Paste commands in the Edit pull-down menu to copy the files to another drive (like the floppy drive) or to another location on the hard disk.

Glossary Acquisition Sweep Acquisition sweep, or sweep speed, sets the time base in milliseconds per division (ms/div). This is the length of the epoch the system records with each sweep. The acquisition sweep may be set at a different speed than the Display Sweep. There are always 10 divisions across the display. Therefore: sweep speed x 10 = total timebase Note: You can set sweep speed only at one of the preset values. If you enter a value not included in the list, the closest preset value is used.

Display Sweep Display sweep, or sweep speed, sets the time base in milliseconds per division (ms/div) of the data displayed in the mode window. The display sweep may be set at a different speed than the Acquisition Sweep. There are always 10 divisions across the display. Therefore: sweep speed x 10 = total timebase Note: You can set sweep speed only at one of the preset values. If you enter a value not included in the list, the closest preset value is used.

Act/Ref Each channel on the amplifier has an active (ACT) and reference (REF) connection. The active connection corresponds to the inverting (-) input and the reference connection to the non-inverting (+) input. When negative voltage is applied to the active input, or when positive voltage is applied to the reference input, an upward deflection is produced on the display. Use the active input for the recording electrode and the reference input for the reference or inactive electrode for a negative up convention. For a positive up convention, reverse the electrode connections.

Active Modes The Active Modes table lists all modes that you have programmed. The check boxes indicate whether those modes will be available for use when the Test is activated. You can turn these modes on or off by checking the box next to each mode.

Active Window This list displays all open windows on the screen. The checked window name is the active window. You can also make a window active by clicking the title bar on the window or anywhere in the window. You know that the window is the active one because the title bar appears highlighted (darker than the title bars of the other windows).

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Add/Delete/Rename View Buttons Click the Add View button to enter an additional view. Click the Delete View button to delete the active View. Click the Rename View button to rename the active View.

Add Marker Adds a time marker. Cursors display in different colors based on which side of the marker they are on. To remove a marker, drag it to the far right or left edge of the window.

Adjust Latency Available after a trial has been selected. Takes the values for the current positions of the auto-cursors on the selected trial and resets the auto-cursor Start Latency to -90% and the End Latency to +110% of these values.

All The All row allows you to select a value for all channels. For example, if you select a number in the All row for the Gain column, that number is entered as the Gain for all channels. You can then change one or more channel specifications as needed.

All Gain Control Use the up/down buttons to change the display gain of all channels at one time.

All Manual Modes The All Manual Modes section allows you to control all manual acquisition modes concurrently. The following options are available: •

Run button: Runs all manual modes concurrently. Click the Run button while it is active to stop all manual modes. Note that if any manual modes are started individually, the Run button is activated.

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Store: Stores the current average for all manual EP modes and the current trace for all manual EMG modes.

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Clear: Clears the current average for all manual EP modes.

All Auto Modes The All Auto Modes section allows you to control all non-manual modes concurrently. The following options are available:

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•

Run button: Runs all modes concurrently. Click the Run button while it is active to stop all modes. Note that if any modes are started individually, the Run button is activated.

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Store: Stores the current average for all EP modes.

Glossary •

Clear: Clears the current average for all EP modes.

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Audio dial: Turns up the speaker volume. Click and drag the Audio dial to adjust the volume. Only channels with audio enabled output to the speaker (see Creating New Procedure Setup File, the Test Montage section).

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Mute: Turns off the audio sound through the speaker when checked.

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Timers: Timer Intervals

Amp Chn The amplifier channel field is automatically generated when you click the Channel button in the Test table.

Amplifier The amplifier has three functions: To provide gain. Since the voltages in the tissues are in the microvolt range, amplification is required to boost the levels. To provide an impedance match between the tissue and the instrument. The tissue is not a powerful source of voltage and care must be taken to not load down the source, which could distort the potential being measured. To provide for the rejection of common mode noise. To accomplish this, differential amplification is used.

Amplifier Channel Buttons Click the amplifier channel buttons to insert the input into the highlighted ACT or REF field in the Test Montage section.

Amplifier Gain The amplifier gain is the gain at which the amplifier hardware is set. For example, if you have an Amplifier Gain of 10, and the display gain for an Average Window set to 5 uV/div, the traces are displayed at the average window setting. EP modes use an amplifier gain of 10 or 20.

Amplitude Markers Shows or hides the amplitude markers. The amplitude value displayed is based on the currently selected trace.

As Recorded When checked, this option sets the display to the same settings that were used during the recording.

As Recorded Gain When this feature is turned ON the appropriate display gain will be shown for the Average window as you move back through the recording timeline. When this feature is 447

Elite Operators Manual turned OFF, the display gain will not change but will remain at its current setting when moving back through the timeline. The default setting is As Recorded Gain turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu.

As Recorded When this box is checked, the display is shown exactly as it was set up during the recording. When this box is unchecked, you can change the setup choices and review the data differently than it was originally recorded.

Audio Controls This area contains four check boxes and an Audio intensity dial that determine what is heard during NerveGuard operation.

EMG Volume - Controls the volume of the Triggered Raw and Free Run Raw audio. The volume of the Threshold Tones and the Free Run Tones is controlled using the audio controls on your computer or external PC speaker. Threshold Tones - When enabled, a unique tone is played when the stimulus threshold level is detected. Triggered Raw - When enabled, the raw audio for the triggered EMG traces is heard during periods of stimulation. Free Run Tones - When enabled, the wav files assigned to the EMG channels will be played if the free-run EMG activity exceeds threshold during periods of free running EMG. Free Run Raw - When enabled, the raw audio for the EMG traces is heard during periods of free running EMG. NOTE: The Mute check box in the Mode Control Window on the main Cascade page mutes all audio regardless of the audio settings in the NerveGuard window. To use the audio functions in NerveGuard, be sure the Mute option is unchecked in the Mode Control window on the main Cascade page.

Auto Place Cursor On Manual When selected, the program will automatically place cursors on runs that are stored manually.

Auto Place Cursors If no traces are selected (yellow) then cursors are automatically placed on the live traces (white). Otherwise they are placed on the selected trace.

Auto Position On-Off

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Glossary When this feature is turned OFF moving the active "white" traces will not automatically re-position the stored or baseline traces, nor will exiting from the Average window’s Setup dialog. The default setting is auto-position turned ON. To turn OFF this feature, click on this entry on the right-click pop-up menu.

Auto Size Select this option to resize surrounding windows as you resize or move one window, in order to continue to view all of the windows concurrently.

Auto Store On Avg Complete This allows the auto-store feature to be disabled when the average count is reached. When disabled, the program will not automatically store the run, it will instead simply clear the averager and start over without storing. The default for this setting is On (enabled).

Auto-Place Cursors on Percent of Average Complete When this setting is enabled the program will automatically place cursors on the active traces when the specified percentage of the total average count is reached.

Auto Store - (MEP) Mode When enabled, this feature will automatically store the results after the stimulus train is delivered.

Baseline Trace Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window.

Cancel Click the Cancel button to close the window without saving any changes made to the file.

Center Marker Centers the marker within the graph. First, set a baseline trial in one of the average windows, collect some data, store a trial, right-click in an Average window and select "Set Baseline." A cyan colored trial displays, which is the "Baseline."

Center Marker on Baseline First, set a baseline trial in one of the average windows, collect some data, store a trial, right-click in an Average window and select "Set Baseline." A cyan colored trial displays, which is the "Baseline." In the Cursor Trend window, a cyan colored dot displays, which represents the cursor value from the baseline trial. "Center Marker on Baseline" moves the marker on top of the baseline dot.

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Center/Range Specifies the range of values to be displayed in the graph. Center defines the value that is displayed at the center of the graph. Range specifies the range of values to display across the width of the graph. For example, if you set the Center to 10 and the Range to 10, values between 5 and 15 display.

Ch 16 Audio Mute When enabled, the audio from the mode will be muted if the signal in Channel 16 exceeds its reject limit.

Camera Setup Displays a dialog to select which video camera to use in this window if you have more than one camera available.

Channel Button After completing amplifier inputs for each channel, click each Channel button you want to assign to an acquisition mode.

Channel Fields Sets the display gain for traces. Channel drop-downs are only enabled when "Trace Mode" cursors are being used. When creating/editing a procedure setup, select "Cursor Setup" for an EP mode and un-check the "Trial Mode Cursors" item.

Channel Labels Shows/Hides the channel labels in the window.

Channel Name The Name field, or Channel Name, is automatically generated based on the amplifier inputs you have entered for the channel. For example, if the Active input for a channel is T12 and the Reference input for that channel is T10, the name would be T12-T10. You can change this name or leave it with the default name. If you change the name for a channel in either the Test table or the Channel Settings section, the name will be changed in both places.

Channel Section Allows you to set the display gain for traces and turn them on or off.

Clear Clears the current average.

Clear Button Click the Clear button to clear all channel fields and enter new data. 450

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Clear Button Click the Clear button to clear all values from the table.

Clear Captured Trace Resets the auto-captured trace to a flat line.

Clear Cursors Clears the cursors from the selected trial/trace.

Client List Displays a list of remote "viewing" computers that are currently connected to a Cascade server.

Control Button The main control button is always initiated in the Standby mode. Clicking on this large button switches the program to Detecting mode. In Detecting mode the program will automatically increase the stimulus intensity and determine threshold as soon as the stimulating device detects a complete electrical circuit such as when the stimulus probe makes with the pedicle screw or patient.

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If the maximum stimulus intensity is reached without obtaining a threshold value, the letters “NR” will be displayed to indicate No Response was detected.

Copy Special Applies filtering to the Copy command. You can select only the data you want to see based on priority, type of event, and individual events.

CSA Shows/Hides CSA (Compressed Spectral Array) trends in the analysis window.

CSA Scale Increase or decrease the height of the CSA plots.

Current Procedure Setup Opens the Procedure Setup window to make any changes to the current procedure setup file. This is used for certain conditions, such as when electrodes fall off. You can make any necessary changes to the amplifier inputs, modes, channels, or views. This option is only available when a procedure file is open.

Detection Mode This control determines how the NerveGuard program functions when a threshold is detected.

Screw Test - When stimulus threshold is detected the program stops stimulus delivery, and reports the stimulus intensity threshold. Continuous - When threshold is detected the program will continue to stimulate and will constantly report stimulus intensity levels. Fixed - To use the Fixed Detection Mode in NerveGuard, select the Fixed Detection Mode button in the upper right corner of the NerveGuard window, set the intensity slider to the desired intensity and click the Control Button to turn off standby. The intensity slider can be controlled by dragging the slider on screen using the mouse, using the up and down arrow keys on the computer keyboard and by rolling the scroll wheel on your mouse. The control button displays in real time the actual stimulus intensity being delivered. If no evoked EMG is detected, the background of the control button is gray. When an evoked EMG is detected, the control button displays the color corresponding to the stimulus intensity as set in the NerveGuard setup. If Threshold Tones are turned on, your computer will play the tone corresponding to the stimulus intensity delivered.

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Elite Operators Manual Evoked EMG events detected in Fixed Detection Mode are logged and displayed in the pedicle screw stim report. Waveforms are stored only if the Store on Autocapture option is turned on in mode setup.

Disp Gain Use the spinner buttons to increase or decrease the display gain for traces. All traces will be changed if no traces are selected. Otherwise, only the selected traces are changed. A gain value is displayed only if all traces have the same gain setting. The spinner buttons are always active.

Display Sweep Specifies sweep length of the traces. The Display Sweep may be set to a different setting than the Acquisition Sweep. Units are milliseconds per division and always ten divisions total therefore: sweep speed x 10 = total timebase

Division Units When checked, the current sweep setting is displayed in the lower right corner of the window. The current gain setting is also displayed in the lower left corner if all traces have the same gain setting.

Dot-to-Dot Markers Center Marker on Baseline: centers a vertical time marker on the baseline value. Center Marker: centers a vertical time marker within the x-axis of the trend. Place Marker at x% of Baseline: positions a vertical marker at +10% (latency trend) or 50% (amplitude trend) of the baseline value.

Dot-to-Dot/Table View

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Glossary Dot-to-Dot/Graph View: Dots mark the cursor values with a straight line between them. This view tracks the Time Bar repositioning. Table View: This option displays a continuously updated table of values for each feature selected. The table contains all values that have been collected, baseline values, events, and the time, value, and percent difference from the baseline for each cursor value. This view also tracks the Time Bar repositioning.

DSA Shows/Hides DSA (Density Spectral Array) trends in the analysis window.

DSA Colors When the DSA View is selected, these controls can be used to select the color scale.

DSA Max Power Set the top level of the color scale when displaying DSA power trends.

DSA Max Voltage Set the top level of the color scale when displaying DSA Voltage trends.

DSA Smoothing Select to smooth selected traces in EEG Windows. This function is only available when the DSA view has been selected.

EEG Burst Suppression The Cascade has three options for computing and display EEG Burst Suppressions. •

Suppression Ratio (%) - the percentage of time spent in suppression during the previous minute.

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Bursts Per Minute (b/m) - number of bursts that began during the previous minute.

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Burst : Suppression - the ratio of time not in suppression to the time in suppression during the previous minute.

Definitions: Suppression - an interval of at least 1 second during which there is no activity above threshold. Burst - a period of time in which the threshold is exceeded with a specified degree of frequency. Algorithm: The EEG data is filtered using an 8 Hz locut filter. The algorithm then begins looking for bursts and periods of suppression using the following rules:

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A burst is a segment more than 700 msec long that exceeds 8 uV in amplitude. If the burst is less than 700 msec, it is considered a noise spike. Bursts must be separated by at least 150 msec, or they are counted as a single burst. If the flat area between bursts is at least 1 second long, then that time is counted as suppression.

The Burst Count and Suppression % are calculated for each individual 10-second epoch. The values that are displayed in the EEG window are the total count for the last minute, or the average suppression % for the last minute. If the Suppression % is less than 25%, then the program assumes that the patient is not yet in burst suppression, and doesn't display the value. The EEG Analysis window shows yellow dots (trend view) for values that are calculated from less than a minute of data (which can occur if the mode is stopped and restarted).

EEG Drawing Selections The EEG window can draw the EEG traces in one of four methods. •

10 Divisions - creates 10 equal horizontal divisions across the width of the EEG window, no matter what the sweep speed setting is.

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10 mm/sec - draws the EEG at a rate of 10 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

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15 mm/sec - draws the EEG at a rate of 15 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

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30 mm/sec - draws the EEG at a rate of 30 millimeters per second. The number of horizontal divisions is dependent on the width of the EEG window and the sweep speed setting.

EMG Run Modes Manual: The Run All, Store All and Clear All buttons at the top of the Mode Controls window do not affect the mode. This mode will respond to the All Manual Mode controls. Auto: If this selection is applied to an EMG mode, it simply means that the mode will be affected by the Run All and Store All buttons. The Clear All button will never affect an EMG mode. Independent: Modes with this setting do not respond to the All Mode Controls or the All Manual Mode Controls. This is typically used for MEP modes.

Enable 16 Ch Reject When this box is checked, the program will pause data acquisition for the mode when the signal in channel 16 exceeds the reject limit. 456

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Enable Auto Capture on Threshold Checking this box causes the Cascade to hold the EMG sweep on the screen until a new threshold crossing occurs. The held sweep is colored "purple" on the screen and is positioned slightly above the Live EMG traces. The triggering sweep is offset by 3 divisions so that any threshold activity which occurs at the end of the sweep can be seen in its entirety. When performing stimulated EMG (i.e., triggered EMG) using the HOLD mode, the auto-captured traces are not offset by three divisions.

Enable Bovie Reject When this box is checked, the program will pause data acquisition and mute the audio for this mode when the Electrosurgery Detector box signals that the bovie is in use.

Enable Store on Threshold Checking this box causes the Cascade to automatically store each EMG sweep that crosses the threshold. Sweeps can be stored at a rate of one sweep every 3 seconds. The EMG Comment dialog is disabled for auto-stored EMG.

Enable Wave/Beep Checking this box causes the Cascade to play the assigned sound file when a channel exceeds its threshold setting. , the sounds are played through the laptop or PC’s speakers, not through the Cascade base unit. To adjust the volume of the sounds, change the laptop or PC’s sound volume. Note: In order to keep the system from beeping due to stimulus artifacts you will need to enable the "Remove Stim Artifacts" feature. It is also necessary to enable "Suppress Audio During Stim".

EP Mode Controls Information and options displays for each EP mode. The mode name displays to identify which controls work with each mode. •

Run button: Starts/stops acquisition for the mode.

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Reject: Displays the current reject percentage, which is the percentage of the total number of sweeps that have been rejected.

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Channel Reject Indicator: When one or more channels in a mode are setting off artifact reject, a Reject icon will appear next to the channel or channels that are setting off the artifact reject. The may adjust the reject levels or turn off Artifact Reject by accessing the Reject Settings dialog.

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AvgCnt: Displays the current average count and the shutoff count.

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EStim Intensity: Intensity knob changes the intensity of the electrical stimulator assigned to the mode. Click on the right or left half of the knob to decrease or increase the current in small increments.

EP Modes

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Elite Operators Manual EP modes can use any type of stimulator. Responses are usually averaged for this type of test in order to unmask the tiny evoked potentials from background noise that might obscure them. However, you can view the live unaveraged data using the Live/Avg control. Cursors mark important latency and amplitude features on waveforms.

ES-5 -10 Stim Splitter This stim splitter provides four standard and one low current output. The ES-5-10 stimulator splitter can be configured as a primary splitter and secondary splitter. The primary stim splitter is always at the physical end of the cable. The secondary splitter is used when more than one splitter is needed, and provides a connection for the primary stim splitter, allowing the two splitters to be "daisy chained" together. The ES-5-10 does not current sensing. Current sensing is required for use of the NerveGuard software.

Event List The event list is created in the procedure setup file as a list of possible events that will be encountered during surgery. This list is an example that might be used. Select an option from this event list to enter it in the Event Window. The current time and most recent traces are also entered in the Event window when you select an event.

Event Text Show: Shows/Hides display of the event text Time: Specifies whether to show the elapsed time, real time (time of day), or no time, when displaying event text.

Events Edit: Enter specific data for the event list you will use during the procedure.

Feature Specifies which cursor feature to trend. Each feature will have a separate graph.

File Names Displays a list of most recently viewed files. Each file name is unique and generated by the system with the patient’s name, and the date and time the file was created.

Freeze The Z-axis depicts the last n minutes of data. Normally, you will see traces "walk" up the display. When this option is checked, the traces are frozen in place and do not move.

Freeze Frame Freezes the live video update.

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Frequency Range (Hz) Select the low and high frequency limits for the horizontal axis. The lowest setting is 1.0 Hz and the highest setting is 30 Hz.

Display Gain The display gain is the input sensitivity of the instrument when data is being collected. This sensitivity determines the vertical scale of the input as displayed on the test screen when set to view the input signal during acquisition. You can adjust gain settings (as well as sweep speed) to ensure proper display of the signal. You can adjust the gain setting independently in each channel. Gain is measured in microvolts per division (uV/div).

Gain Specifies the display gain for the trace.

Grand Average Allows stored trials to be averaged together. This function is only available when more than one stored trial has been selected in the window. The resulting grand average traces, for each channel, are displayed in 'green' color and the trace label will contain the letters 'GA'.

Graticule When checked, the graticule or grid is visible in the selected window.

HiCut, LoCut Each channel can be configured with default HiCut and LoCut filter settings. You can adjust the settings as needed according to the situation and type of signal you are measuring. You can set the filters independently in each channel. Values are in hertz (Hz).

Horizontal Trend When enabled, the Dot-to-Dot trend is drawn horizontally rather than vertically.

Impedance Impedance is the resistance to alternating current flow. It can affect the signals from the recording electrodes. You should check impedance before the start of every recording and during the recording if there is reason to suspect poor between the electrode and the patient. Impedance levels below 5 kilo Ohms (kOhms) are acceptable for most tests. The following colors are used to indicate the impedance level for each electrode pair: Green

< 5 kOhms

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5 - 15 kOhms

Red

> 15 kOhms

Intensity Bar This region of the NerveGuard window indicates that the stimulus intensity if increasing and also shows the “High Z” impedance symbol. The “High Z” symbol is displayed when the circuit between the stimulating probe (cathode) and the return electrode (anode) is incomplete. When the circuit is completed, such as when the stimulus probe makes with the pedicle screw, the “High Z” symbol will be cleared and the program will automatically begin to increase the stimulus intensity. The red, yellow and green bars will ramp up as the intensity of the stimulator increases. When the stimulus probe is removed from the pedicle screw, the “High Z” symbol will return and the stimulus intensity is immediately returned to the starting value.

Insert Copy Button Click the Insert Copy button to copy the selected window in the view list. For example, the Waterfall window stacks the traces for a particular channel. You may want more than one Waterfall window in order to stack traces from another channel at the same time.

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Glossary Check the Invert box to flip channel polarity, such as when sharing channels between modes.

Label Format Select whether you want the trials/traces labeled with the trial name or with the time of day (TOD).

Lock Graph If this option is checked, the dots on the histogram window, which represent the cursor value from the baseline trial, are locked in place. If "Lock Graph" is un-checked, you can drag the "dots" around in the histogram window to center them.

Marker Shows/Hides a vertical marker to provide a reference point for the graph. You can use this marker to quickly determine if the values are above or below a particular value.

Max Intensity Sets the intensity upper limit for the electrical stimulator assigned to this mode. When running the procedure the electrical stimulus intensity knob will not dial past this setting.

MEP Mode Similar to an EP mode in function but this type of mode does not have a Run/Stop control (only Single, Store, and Clear), and it does not respond to the All Mode Controls or the All Manual Mode Controls. Instead of a Run/Stop control, MEP modes have a "Single Trigger" button. Stimulus types are TCS-1, CV-2, Flash (old external trigger), External Trigger, or Electrical.

MEP Mode Controls Single Trigger - initiates one TCS-1 or CV-2 stimulus train, or one external trigger pulse. Store - stores the responses. Clear - clears the active traces. Intensity knob - changes the intensity of the TCS-1 or CV-2 stimulator assigned to the mode. Click on the right or left half of the knob to decrease or increase the voltage in small increments. Note: There is no Run Mode setting for MEP Modes, these types of modes do not respond to the All Mode Controls or to the All Manual Mode Controls, they only respond to their individual controls (e.g., the Single Trigger button).

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TCS-1 Mode Controls

MEP Mode Options: Autostore: Check this option to have the Cascade automatically store the traces after the stimulus train is delivered. Setup Reject Info: Enable Bovie Reject: Up to four electrocautery detection probes can be connected to detect the use of a Bovie device. Select this option so that data is not collected during periods of electrocautery use. Enable Channel 16 Reject: This channel can be used as a reject channel. Select this option to pause all data collection and mute the audio when the data on this channel exceeds the threshold. Reject: Check the Reject option to eliminate excessive movement artifacts or other sources of noise from the running average. This reject is based on a preprogrammed percentage (usually 50%) of the amplifier’s full bandwidth setting. The total number of sweeps that are rejected is displayed in the Mode Control window as a percentage. This option automatically enables artifact rejection on all channels assigned to the mode. You can disable the feature for individual channels by removing the check mark next to the appropriate channel in the Channel Settings section. When artifact rejection is completely disabled for all channels, every collected sweep is included in the running average. In the Mode Control window, the reject status is indicated as OFF. Remove Stim Artifact from EMG: For stimulated EMG modes, select this option to remove the stimulus artifact from the display and audio output. When this is selected for an EP mode, which is using an electrical stimulator (i.e., Rt Median SEP), it will enable the stimulus artifact to be removed from EMG traces. The system zeros the data during stimulus delivery and for a -selectable time period between 0.5 to 5.0 milliseconds after the stimulus.

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Mode Add: Add one or more modes Delete: Delete the active mode. Rename: Rename the active mode. AutoName: Changes the channel name to reflect the Act-Ref values.

EMG Trace Area During stimulus delivery this area displays triggered EMG traces. The most recent sweep is displayed (typically in white) as well as the last sweep to exceed the threshold criteria (typically in purple). When stimulation is not being delivered, this area displays free running EMG traces at a fixed sweep speed of 100 msec/division.

NOTE: Right click over the trace area to access functions such as Mode Setup (including the NerveGuard Setup Submenu) and Window Setup.

Print Report Button Click this button to generate a summary report listing the levels stimulated and their corresponding threshold values. Use the report template called, “Pedicle Screw Stim Report”.

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Below is an example of the report summary table.

NOTE: If no side & level are selected on the Spine Graphic prior to stimulation the summary report will include a row with a site name entry of “Not Specified”. NOTE: If the maximum stimulus intensity is reached without obtaining a threshold value the summary report will indicate “No Response Detected at Max Stim” for that site.

Norm Percent Change Enter the percent change from baseline that is normally allowed for the cursor value. Latency values are considered abnormal when they exceed this entry (i.e., +10%), amplitude values are considered abnormal when they are decreased by the amount entered (i.e., -50%). Abnormal values are indicated by red text in the table format and by red squares in the dot-to-dot format.

Notch/Audio Check the Notch box to reduce unwanted interference from power lines for that channel. The notch frequency is determined in the System Setup window, it can be either 60 or 50 Hz. Check the Audio box to output the channel to the speakers.

Paging Controls Use these toolbar buttons to go forwards/backward by one page or by one half page. Click on the middle button to return the display to Live EEG.

Pause EEG Analysis

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Glossary Stops EEG Analysis. Live EEG continues to be recorded. When the EEG Analysis is paused, 'red' tick marks will be displayed in the trend plots.

Pause Averager When selected on, the Pause Averager option pauses the averager while allowing s to control the stimulator as normal. The default state is for the Pause Averager option to be unchecked. To turn the Pause Averager on, right click in the data window of an EP Average or Triggered window and select the Pause Averager option. When the Pause Averager option is selected on, the Average count in the Mode Control Windows and in the Date windows will show “Paused.” The mode will remain in Pause Averager mode until the option is unchecked.

Play Sound on Stim When this box is checked the program will play a brief sound (WAV file) whenever stimulus current is delivered to the patient. Use the folder icon to browse to the WAV file you want to assign to this feature. Use the speaker icon to test the WAV file you have selected. The icon for this feature is only available if a stimulator has been selected for the mode. Note: The WAV file is played through the PC's speakers, not through the Cascade Base Unit's speaker.

Print EEG Report Select this option to generate an EEG report.

Select Print Current window to generate a report with just the traces from the current EEG window. Select Print range to generate a report that includes all the EEG traces over a specified time range.

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Print Procedure Setup Click the Print button in the Procedure Setup window to generate a report that contains the procedure setup information. There are two factory default templates provided for this: Amplifier Setup.rpt: Prints just the amplifier input labels. Procedure Setup.rpt: Prints the entire procedure setup, including amplifier inputs, test montage, mode setups and channel settings, view setups, and event list.

Print Screen Selecting this option from the File menu sends a picture of the current screen to the default printer. The screen print includes the status bar which contains the current (clock) time and the elapsed time.

Pulse Width Sets the duration of the electrical stimulus pulse. The pulse width is measured in microseconds (usec).

Refresh Updates the image in the window.

Refresh Rate Specifies how often the image in the window is updated.

Reject When artifact reject is enabled, the reject percentage value is displayed in the window. If the amplifier gain setting is 10 uV/division this means that the Live trace has an amplitude window of 100 microvolts (10 vertical divisions times 10 uV/div.) with 50 uV above baseline and 50 uV below baseline. If the reject level is set to 50%, then the amplitude of the Live trace can’t exceed +/- 25 uV or it will be rejected from the running average. The lower the reject level setting the more sensitive the program will be in rejecting large artifacts.

Reject Setting Dialog The Artifact Reject Dialog allows for quick and easy adjustment of reject levels, allows reject to be turned off for individual channels, displays the frequency components of a selected channel and allows for turning on/off the Bovie Reject and Channel 16 reject features.

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• Channel Reject Indicator: When one or more channels in a mode are setting off artifact reject, a Reject icon will appear next to the channel or channels that are setting off the artifact reject. The may adjust the reject levels or turn off Artifact Reject by accessing the Reject Settings dialog. • There are four ways to access the Reject Settings dialog - Click the Reject icon . - Select the Reject Settings option from the right-click menu in the EP mode. - Click the Setup Reject Info from the EP Global controls dialog located on the tool bar. - Click the Setup Reject Info from the Procedure Setup dialog. • When the Reject Settings dialog is accessed via the Reject icon, the dialog will default to highlighting the channel associated with the icon that was clicked to access the Reject Settings dialog. When the Reject Settings dialog is accessed in any other way, the dialog will default to highlighting the first channel in the list. • The threshold data window displays reject level bars indicating the upper and lower limits of the threshold window. Live, free-running data for the highlighted channel is displayed in the threshold data window if the mode is running. • Adjust the artifact reject level to the desired setting by clicking on the squares on the reject level bars and dragging the bars to the desired position. 467

Elite Operators Manual • Reject numeric artifact reject levels for each channel are listed in the fourth column of the channel list. The reject levels are displayed as percent of total gain and as micro Volts. • To adjust the artifact reject limits for other channels in the mode, click on the channel name and adjust the reject level bars. • To increment the reject limits for of all channels at the same time, click the up/down arrows on the All spinner control. • To turn off artifact reject for one or more channels, deselect the check box for the appropriate channel in the Reject column of the channel list. • The Noise Analysis sub-window at the bottom of the dialog displays the FFT analysis of the live data for the selected channel. This allows s to identify the dominant frequencies of the live data for the selected channel. • Changes made in the Reject Settings dialog are applied immediately. The averager continues to run when exiting the Reject Settings dialog. Enable Bovie Reject: Up to four electrocautery detection probes can be connected to detect the use of a Bovie device. Select this option so that data is not collected during periods of electrocautery use. Enable Channel 16 Reject: This channel can be used as a reject channel. Select this option to pause all data collection and mute the audio when the data on this channel exceeds the threshold. Reject On: Check the Reject option to eliminate excessive movement artifacts or other sources of noise from the running average. This reject is based on a pre-programmed percentage (usually 50%) of the amplifier’s full bandwidth setting. The total number of sweeps that are rejected is displayed in the Mode Control window as a percentage. This option automatically enables artifact rejection on all channels assigned to the mode. You can disable the feature for individual channels by entering the Reject Settings Dialog and removing the check mark next to the appropriate channel in the Reject column. When artifact rejection is completely disabled for all channels, every collected sweep is included in the running average. In the Mode Control window, the reject status is indicated as OFF.

Remove Stim Artifact From EMG Checking this box in the EP Mode Setup window will remove the stimulus artifact related to the EP stimulator from the Live EMG traces. The system zeroes the data during stimulus delivery and for a selectable time period between 0.5 to 5.0 milliseconds.

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Glossary To remove the stim artifact and suppress the audio, turn on Remove Artifact From EMG in the SEP mode and turn on the Remove Stim Artifact option in the live EMG mode. The Suppress Audio During Stim option in EMG only applies to the EMG stim. For example, if you have an SEP and a live EMG and want to eliminate the visible stim artifact and the audio stim artifact in the EMG, turn on Remove Stim Artifact From EMG in the SEP mode. In the EMG mode, turn on the Remove Stim Artifact. The Remove Artifact From EMG option available in SEP modes will always mute the audio in the EMG mode during stim artifact from the SEP. This is the only way to mute the SEP artifact. The Remove Stim Artifact option in EMG modes will simply remove the visible stim artifact; but only if Remove Artifact From EMG is on in the SEP mode. If you want to mute SEP artifact in EMG but still see the artifact, turn on Remove Artifact From EMG in the SEP mode and turn off Remove Stim Artifact option in EMG modes.

Rename Window Button Click the Rename Window button to enter a new name for the selected window in the view list.

Resolution Specifies the resolution of the image acquired from the camera. The image is always stretched to fit the window.

Rotate/Tilt Lock Position: If checked, you cannot change the graticule orientation by dragging the corners. Rotate/Tilt: Allows you to change the orientation of the graticule.

Run Starts and stops acquisition for the mode.

Run Mode Select Manual or Auto for the Run Mode (the default is set to Manual). Manual: The mode can be started and stopped by clicking on the individual Run button for the mode. The Run All, Store All, and Clear All buttons do not affect the mode. Auto: The mode can be started and stopped using the All Mode controls.

Select All 469

Elite Operators Manual This function selects are trials that are currently displayed within the window.

Setting Baselines Sets the currently selected trace as the baseline if no trials are selected. Note that baselines are set on a "per-mode" basis so if you set the baseline in a 3D window or an Average window, the trial associated with the trace will show up in all other windows that display baselines and are connected to the same mode. Baselines can also be reset selectively rather than as a group. This is useful when one or more channels in a mode show poor morphology when the initial baselines are set and the waveforms for that channel or channels have improved. Instead of resetting baselines for all channels, you can now reset baselines for just the channels of your choosing. To selectively reset baselines, select the waveform or waveforms you wish to use as the new baseline and select the Set Baseline option in the right-click menu of the mode. The Trial Select option will need to be turned off in order to select waveforms without selecting all waveforms in a trial. When setting or resetting baselines, only one waveform per channel may be selected. As always, if no baseline is set when you select the Set Baseline option, the system will use the last stored trial as baseline. If no trial has been stored, the system will store the average trial and set it as baseline.

Set Epoch Length CSA/DSA epoch length may be adjusted by right clicking in the EEG Analysis window and selecting the desired epoch length from the Epoch length sub menu. s can select from choices of 2, 4, 8, 16, and 32 seconds.

Setup Stim For EP, MEP, TOF, or Triggered EMG modes, click Setup Stim to set up stimulator specifications, such as rep rate, label name, stimulator number, pulse width, and maximum intensity.

Setup Tables 470

Glossary Select the cursors that will be included in the reports, and select whether you want to include baseline information.

Show The Show section allows you to select the following options: Labels: Shows/Hides the axis unit labels. Trace Name: Shows/Hides the label of the trace displayed. Graticule: Shows/Hides the values for all three axes. Baseline: Shows/Hides the baseline trace. When baselines are selected they are automatically placed at the bottom of the selected trend window.

Show Baseline This option for each column in a Cursor Trend window shows the current baseline value for the feature being trended, and is displayed as a line at the bottom of the display. When the "Display Baseline Value" option is turned on, a value is displayed which is the difference between the baseline value and the most recent value. This value is displayed as a percentage. For example, if the baseline value is 5.0 and the current value is 4.0, the value displayed will be -20.0%. If the current value is 7.5, the value displayed will be 50.0%.

Show Baseline Dot-to-Dot This option for each column in a Cursor Trend window shows the current baseline value for the feature being trended, and is displayed as a 'blue dot' at the bottom of the display. When the "Show Baseline" option is turned on, a value is displayed which is the difference between the baseline value and the most recent value. This value is displayed as a percentage. For example, if the baseline value is 5.0 and the current value is 4.0, the value displayed will be -20.0%. If the current value is 7.5, the value displayed will be 50.0%.

Show Burst Suppression Info Enables the display of burst suppression calculations for the channels that are checked.

Show Section (Table View): Events: Shows/Hides display of the event text. Baseline: Shows/Hides baseline. When baselines are selected they are automatically placed at the bottom of the selected trend window. Percent: Shows/Hides the percentage difference between the baseline and most recent data point in the Cursor Trend window. Time: Specifies whether to show the elapsed time or real time (time of day) when displaying event text. 471

Elite Operators Manual

Show Section (Dot-to-Dot View): Labels -Shows/Hides the minutes labels. Baseline - Shows/Hides the baseline dot and % change value. Feature Name -Shows/Hides the cursor value being trended, i.e. N20. Trend (min) - Specifies the amount of time to show in the trend.

Show Cursors Shows or hides the cursors on the trace lines in these windows. Cursors mark important latency and amplitude features on waveforms. See Working with Cursors for more information.

Show Events Select this option to display the event text in the Cursor Trend window.

Show In Trace Windows Graticules: Shows/Hides the graticule in the trace display windows. Trial Numbers: Shows/Hides the trial number in the trace display windows. Division Units: When checked, the current sweep setting displays in the lower right corner of the window. The current gain setting also displays in the lower left corner if all traces have the same gain setting. ‘Mode Trace‘ Labels: Shows/Hides labels of mode trace names. Baselines: Shows/Hides baselines. When baselines are selected they are automatically placed at the bottom of the selected trend window.

Show Percents Select this option to display the percent change, or the percentage difference between the baseline and most recent data point, in the Cursor Trend window.

Show Trial Numbers Select to display the trial numbers in the trace label.

Show Trial Numbers and Time Trial Number : When enabled every fourth trial number will be displayed on the traces. Trial Times: When enabled the trial times will be displayed in the far right-hand column. Channel Names: When enabled the channel names will be displayed in the top left of each trace window.

Single 472

Glossary Fires the assigned stimulator once.

Smooth Click this button to smooth the selected trial/trace. If no trial/trace is selected the active traces will be smoothed.

Smooth/Unsmooth Select Smooth to smooth selected traces in EP Windows. Select Unsmooth to reverse smoothing.

Sync with Server Button During a remote monitoring session, click on this button to cause the Reader to sync to the same view as that currently displayed on the Cascade.

Spectral Edge Shows/Hides the spectral edge indicator and selects the spectral edge frequency value (50, 90, 95, 97 or 99 %). Spectral edge is always determined for the total frequency band of 1 – 30 Hz.

Stim Hold/Stim Rep Stim Rep (Stimulate Repetitive): Turns repetitive stimulation on/off. Stim Hold (Stimulate Hold): Turns Stim & Hold mode on/off. When on, the EMG mode fires the stimulator at the specified reprate and displays single sweeps triggered by each stimulus. When unchecked, the EMG mode runs in the default, free run mode. When this box is checked, the Repetitive checkbox is automatically checked and disabled.

Stim Type The Cascade uses electrical, ES-IX, audio, visual, TCS-1, and CV-2 stimulators. Select a stimulator type from the drop-down list. Click the Setup Stim button for various options to set up each stimulator type. To trigger an external device, select "External Trigger". A special external trigger interface box is required for this implementation.

Stimulate When checked, the EMG mode will fire the stimulator and the specified rep rate and display single sweeps triggered by each stimulus. When unchecked, the EMG mode runs in the default, free run mode.

Store Stores the current average.

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Store Stores the current average. Stores the currently displayed data to the Event log. This event will display on the timebar and in the Go To dialog, but will not show up in the Event Window. When the file is reviewed, the last stored data will be displayed. Each time you click Store for an EMG event, a Comment box displays for you to enter additional information.

Store Image On These controls specify when a video image is stored to the data file. Care should be taken when selecting these setting since video images can greatly increase the size of a data file. Interval: When checked, images are stored on the specified interval. Event: When checked, an image is stored whenever an event is entered. EP Average Done: When checked, an image is stored when a new trial is stored in any EP mode. EMG Store: When checked, an image is stored whenever an EMG sweep is either manually or auto-stored.

Suppress Audio During Stim Select this option to suppress the sound of the stimulus artifact from the audio while that mode is running.

Sweep Delay Sweep delay determines the start of the sweep relative to the onset of the stimulus. A pre-stimulus sweep delay (negative value) is useful for acquiring pre-stimulus or baseline-level activity. A post-stimulus sweep delay (positive value) can be used to remove stimulus artifact from the display. The value can be set to -1.0, 0.0, or 1.0 division. Sweep duration is always 10 divisions long.

Symmetry Shows/Hides DSA trends with symmetry trends plotted down the middle in the analysis window.

Take Snapshot Stores the current video image to the file. A Comment box displays each time a snapshot is taken.

Test Add: Add a test when you need more than 16 amplifier channels. Delete: Delete the active test. 474

Glossary Rename: Rename the active test. AutoName: Changes the channel name to reflect the Act-Ref values.

Threshold Markers When enabled, the threshold setting for each channel is indicated by yellow markers.

Time Bar Event Marks Select priority specifications for the time bar event marks. Do not show if priority less than: If you select Medium from this drop-down list, events with a priority less than medium will not display in the time bar. Skip when jumping from event to event if priority is less than: If you select Medium in this drop-down list, the scroll box will skip event markers if the event has a priority less than medium.

Timer Intervals Two timers allow modes to start on a specified interval. The interval can be set in the main setup dialog or from the mode control view. These timer values are stored in the setup file. For example, if Timer1 interval is set to 60 seconds, and the Run All button is clicked, the modes run until their average count is reached. The trial will be stored, cursors placed, and the averager cleared. When 60 seconds has elapsed from when the last mode in the group has completed, the modes start again. If the Run All button is turned off, the timers are paused. A Clear Timer function is available in the Mode Control View. These selections are only available for EP modes

TOF Mode The TOF (Train Of Four) mode allows for monitoring the patient’s degree of neuromuscular blockade. A train of four stimulations are delivered to the patient and the program automatically records the responses to each stimulus and determines the amplitude and area of each response, if present. Stimulus artifact in the Train of Four mode is suppressed for two milliseconds for each stimulus in the train.

TOF Mode Controls •

Run button: Starts/stops acquisition for the mode.

•

Single Button: Fires the assigned stimulator once.

•

Store Button: Stores the current average.

•

Clear Button: Clears the current average.

•

Reject: Displays the current reject percentage, which is the percentage of the total number of sweeps that have been rejected.

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Channel Reject Indicator: When one or more channels in a mode are setting off artifact reject, a Reject icon will appear next to the channel or channels that are setting off the artifact reject. The may adjust the reject levels or turn off Artifact Reject by accessing the Reject Settings dialog.

•

Stim Intensity Knob: Intensity knob changes the intensity of the electrical stimulator assigned to the mode. Click on the right or left half of the knob to decrease or increase the current in small increments.

•

Run Mode This setting defines how a mode reacts to the Run All, Store All and Clear All buttons in the Mode Controls while running a procedure. The option is within the Procedure Setup screen, and in the Mode Control window. The following selections are available: •

Manual: The Run All, Store All and Clear All buttons in the All Auto box of the Mode Controls window do not affect the mode. This mode will respond to the All Manual Mode controls.

•

Independent: Modes with this setting do not respond to the All Mode Controls or the All Manual Mode Controls. This is a good choice for MEP modes.

•

Timer1/Timer2: Two timers allow modes to start on a specified interval. The interval can be set in the main setup dialog or from the mode control view. These timer values are stored in the setup file. For example, if Timer1 interval is set to 60 seconds, and the Run All button is clicked, the modes run until their average count is reached. The trial is stored, cursors placed, and the averager cleared. When 60 seconds has elapsed from when the last mode in the group has completed, the modes start again. If the Run All button is turned off, the timers are paused. A Clear Timer function is available in the Mode Control View. These selections are not available for EMG modes.

Trace Labels When checked, channel labels are displayed next to the traces.

Trace Name Trace Name or Feature Label displays the name of the feature within the graph.

Trace Windows Trace Window 1-4 specifies which trace to display, if any. The drop-box lists all traces from all EP modes.

Train Setup Used to program the duration (in seconds) and the repetition rate (in Hz) of the EMG train stimulus.

Trend Specifies how many minutes of data the graph will display.

Trend Count 476

Glossary Specifies the number of stored trials to display. Stored trials are displayed in a trend fashion with the most recent trial at the bottom.

Trend Shows/Hides power trends in the analysis window. Specifies how many minutes of data the graph will display.

Trend Settings Trend: When the Trend View is selected, these controls can be used to select the type of data to be trended. Select from Total Power, Absolute Power, or Relative Power. When either Absolute or Relative power are selected, the frequency band can also be selected (Delta, Theta, Alpha, Beta, Delta+Theta, or Alpha+Beta). Range (pW): Sets the maximum limit for the horizontal (x-axis) of the trend displays.

Trend Time Determine the amount of data displayed in the vertical axis; for example, the last 10 minutes of data.

Trial Select When this option is checked, clicking on a trace selects or clears all the traces for a trial. When unchecked, traces are selected individually.

Trigger Causes the assigned MEP stimulator to deliver one stimulus train.

View Selection The items at the bottom of this menu are the names of the views from your setup file. The radio mark shows which view is currently selected. Selecting any of these items takes you to the corresponding view.

Voltage, Power, ZScore Select one of the following options: Voltage: Changes the analysis window to display voltage (microvolts). Power: Changes the analysis window to display power (pW or microvolts squared). Power is the most common setting to use for CSA and DSA displays. Z Score: Changes the analysis window to display the difference (in z-score units) between the trended data and the most recently selected baseline. This is most commonly used with DSA displays.

Waveforms 477

Elite Operators Manual The Waveforms section allows you to select the following parameters: Trace: Selects which trace is displayed. Sweep: Specifies at what sweep to display the traces. Note that this value does not effect the mode sweep setting. Select Default if you want the sweep to track the mode sweep setting. Gain: Specifies the display gain for the trace. Trend: Specifies how many minutes the Z-axis displays. X/Y/Z Divisions: Specifies how many divisions each axis displays.

Waveforms The Waveforms section allows you to select the following parameters: Trace: Selects which trace is displayed. Sweep: Specifies at what sweep to display the traces. Note that this value does not effect the mode sweep setting. Select Default if you want the sweep to track the mode sweep setting. Gain: Specifies the display gain for the trace. Trend: Specifies how many minutes the Z-axis displays. Order (time): The traces can be trended in ascending or descending mode. In ascending mode, the most recent stored trace appears at the bottom of the graph and moves upward as new traces are added to the stack. In descending mode, new traces appear at the top of the graph and move downward. The current time of day is displayed at the top (descending mode) or bottom (ascending mode) of the Y-axis.

Window Setup Button Each type of window (Average, 3D Trend, etc.) has its own unique setup dialog specific to the operation of that window. Click the Window Setup button to set up various specifications such as Trend Count, Trend Time, or Display Gain.

Z Score Colors When the DSA View and the Z Score items are selected, the Z Score controls can be used to select the Z Score color scale.

Zoom Control Click the drop down arrow to view the Full Spine or zoom-in on the Lumbosacral, Thoracic, or Cervical segments.

478

Glossary

Zoom In/Zoom Out Use these options to quickly modify the range of values displayed in the graph.

479

Index 3

Auto Size 70, 449

3D Trend 228, 277

Auto Smooth 192

3D Trend Window 228

Auto Store 449

3D Trend Window Setup 277

Autostore 186

3D Window Setup 277 A

Average Window 203

ABR Filters 192

Averaging Waveforms 105 B

Acquisition Sweep 186

Bar Electrodes 405

Act/Ref 445

Baseline 110, 470, 471

Activating Software Licenses 48

Baseline Trace 449

Active Modes 445 Active Window 445

Bovie Reject 106, 194 C

Add Marker 446

Cabling Diagrams

Add View Button 446

Elite Base Unit Connections 12

Adjust Latency 446

Cabling Diagrams 24

All 446

Cabling Setup Instructions 14

Amplifier 417, 418, 447

Calibration 417

Amplifier Calibration 68

Camera Setup 450

Amplifier Diagnostic 420

Cancel 449

Amplifier Diagnostics 68

Cascade Customer 433

Amplifier Input Extender Cable 23

Cascade File Extensions 82

Amplitude Markers 218, 447

Cascade Tokens 364

Append to Procedure 68

Center 449, 450

Appending to Procedure 113

Ch 16 Audio Mute 450

Approvals 437

Channel 450

Archiving 424

Channel 16 Reject 194

Artifact Reject 165, 466

Channels 173

As Recorded 447, 448

Charts 403, 404, 405, 406

Audio 450

Chat Box 338

Audio Controls 152, 448

Chat Log 338

Auditory Stimulator 299

Checking Impedance 103

Auditory Stimulators 299

Choice Token 367

auto cursors 197

Choices within Options 378

Auto Place Cursors 109, 449

Choosing Appropriate Repetition Rate 121

Auto Position On-Off 448

481

Elite Operators Manual Cleaning Cleaning Electrodes 414 Cleaning Equipment 413 Cleaning Stimulators 413 Cleaning 413 Clear 450, 451 Client List 451 Close 167, 380 Colors tab 63 Command Prompt 347 Comment 373 Comment Token 373 Compliances 437 Computer Requirements 55 Configurations 388 constant voltage stimulator 5 Cascade 433 Control 48 Copy 358 Copy Special 453

Customizing the Appearance of the Template 358 Customizing the Report Header 361 D Data Rates for Remote Monitoring 343 DCOM Configuration 328 Default Report Templates 354 Delete View Button 446 Determining Frequency of Noise 129 Digital Filter 192 Digital Filters 192 Disconnect 344 Display Gain 439 Display Sweep 445 Disposable Bar Electrodes 404 Disposal of Equipment 397 Dot-to-Dot 471 DSA 455 DSA Max Power 455 DSA Max Voltage 455

Copying Templates 358

DSA Smoothing 455

Copyright and Trademarks 3

Edit Events 285

DSP Utilization Meter 285 E

Creating a Shortcut to a Network Location 51

Edit Menu 132, 453

CSA 453

Edit Report Templates 357

CSA Scale 453 Current Procedure Setup 453 Cursor Table 197 Cursor Tables 197 Cursor Trend Window 229 Cursors 109, 229, 448, 449 Customer Help File Access 433 Customer 433

482

Edit Procedure 68 Editing Procedure 113 Editing System Setup 57, 63 EEG Burst Suppression 455 EEG Drawing Selections 456 EEG Needle 404 EEG Analysis EEG Analysis Window 225, 305 EEG Analysis Window Setup 270

Index EEG Analysis Window 225

EP Mode Setup 154, 178

EEG Analysis Window Setup 270

EP Summary Window 209

Electrical Safety 388

Epoch Length 470

Electrical Stim Splitter Family Guide

Error Messages 344

Current 8

Event Window 233

Daisy Chain 8

Event Window Setup 251

High Current Outputs 8

Events Menu 136

Low Current Maximum Output 8

Example EEG Analysis Windows 305

Electrical Stim Splitter Family Guide 8 Electrical Stimulator 293

Exporting Data 114 F

Electrical Stimulator Characteristics 406

Features & Accessories

Electrode Current Densities

Bedrail Handle 25

Bar Electrodes 405

Cable Guide 25

Disposable Bar Electrodes 404

Quick Connect 25

EEG Needle 404

V-Block Clamp 25

Electrical Stimulator Characteristics 406

V-Blocks 25 Features & Accessories 25

EMG Needle 403

Felt-Pad Bar Electrodes 405

Felt-Pad Bar Electrodes 405

FFT Marker 129

Electromagnetic Compatibility 391

File Extensions 82

electrosurgery detect unit 5

File Menu 113, 131

Electro-Surgery Reject 106

Flash 300

Elite Cabling Setup Instructions 14

Frequency of Noise 129

EMG EMG Run Modes 456

Frequently Asked Questions 439 G

EMG Window Setup 245

General Care of TCS-1 415

EMG Needle 403

General Cleaning 413

EMG Pane Selection 213

Global EP Settings 111, 129

EMG Window 213

Global Summary Window Settings 280

EMG Window Setup 245

Global Summary Window Setup 280

EP 203

Global Waterfall Window Setup 282

EP Analysis Window Setup 264

Goggles 300 H

EP Average Window 203 EP Average Window Setup 242 EP Button 111 EP Cursor Trend Window Setup 260

Hardware Setup 11, 12, 23, 24 Hardware simulator 32 Help File Access 433

483

Elite Operators Manual Help Menu 138

Test Menu 135

Help with Windows 67

View Menu 133

High-Z Warning 165

Window Menu 137

How to Edit Report Templates 357 I

MEP Mode

IEC 60601-1-1 388

MEP Mode 461

Impedance 103

MEP Mode Controls 154, 461

Impedance Test Arrays 420

MEP Mode Options 462

Initializing a Remote Monitoring Session from the Cascade 334

MEP Mode Setup 186

Initializing a Remote Monitoring Session from the Reader 333

MEP Window Setup 246

Inserting the Contents of RTF/Bitmap Files 379 Installation Instructions 35 Intended Use Cascade 7 TCS-1 Stimulator 7 L LAN 324 LED Check 300 License Key Requirements 48 Live EEG Window Side-by-Side Comparison of Current and Past EEG 112 Live EEG Window Setup 249 Live Video Window Setup 263 Lock Windows 70 Look Back 112 M Menu Bar 73 Menu Options Edit Menu 132 Events Menu 136 File Menu 131 Help Menu 138 Remote Menu 135

484

MEP Mode Setup 186

MEP Triggered Window 218 Minimum Computer Requirements 55 Mode Control Window Setup 241 Mode Controls 153, 202 Mode Group Cycle 285 Mode Groups 285

Mode Setup EP Mode Setup 178 MEP Mode Setup 186 Mode Setup 165, 177 Mode Windows Overview 202 Mode Windows Setup Overview 202 Modes 111, 445 Moving windows 70 Mute 106, 450 N NerveGuard Closing NerveGuard 152 Dertimination of Threshold 140 Fixed Detection Mode 142 Making Changes during testing Stimulus Settings 142 Threshold Settings 142 Making Changes during testing 142 NerveGuard and Remote Monitoring 143

Index NerveGuard Introduction 139 NerveGuard Operation 139

TCS-1 Stimulator 5

NerveGuard Setup Submenu 149

Overview 5 P

NerveGuard Window

Parts of a Window 73

Audio Controls 152, 448

Pause Analysis 464

Control Button 146, 451

Pause Averager 465

Detection Mode 148, 453

Peer to Peer 324

EMG Trace Area 149, 463

Performance/Operational Recommendations 64

Intensity LED 150, 460 Print Report 151, 463 Setup Submenu 149 Using the Spine Graphic 144 Zoom Control 152, 478 NerveGuard Window 143 Pedicle Screw Threshold Detection 141 Starting a New Procedure 99 NerveGuard 139 NerveGuard Procedure Setup 289 NerveGuard Window 143 NerveGuard/Continuous Stimulation Mode 141 Network Card 324 Network Location 51 New Procedure 68

Peripheral Devices and Connections 23 Phone Numbers 433 Print 32, 465, 466 Procedure 169 Procedure Setup 171 R Recording TcEMEPs 153 Reducing Noise 116, 121 Reject 194 Reject Setting Dialog 466 Remote Menu 135 Remote Monitoring Cascade 2nd Network Card & Reader Network Card 324 Cascade Start Page Overview 68 Connection Scenarios

Noise Reduction 116, 121, 129

Peer to Peer on a LAN 322

Noise vs Rep Rate 121 O

Third Party Software 323 VPN into LAN 322, 332

On/Off 67

VPN to VPN setup 332

Opening An Existing Template 356

Connection Scenarios 319

Opening and Closing Cascade 68

Data Rates for Remote Monitoring 343

Other Setup 285

Initializing a Session from the Cascade 334

Overview Cascade 5 Components 5 NerveGuard 5

Initializing a Session from the Reader 333 NerveGuard and Remote Monitoring 143

485

Elite Operators Manual Remote Monitoring 317

SF Filters 192

Remote Reader 317, 318, 323, 336, 344

Shipping Equipment 434

Remove Stim Artifact 186

Show Baseline Dot-to-Dot 471

Remove Stim Artifact From EMG 468 Rename View Button 446

Side-by-Side Comparison of Current & Past EEG 112

Rep Rate 121

Signatures in Reports 362

Repair 427

Snyc with Server Button 473

Report Generation Process 349

Software Installation Instructions 35

Report Generator 349, 350

Software Setup Overview 35

Report Header 361

Software Upgrades 428

Report Templates 357

Stacked EMG Window 216

Reports 341, 350, 362

Stacked EMG Window Setup 268

Resizing windows 70

Standards 437

Review Procedure 68

Start New Procedure 68

Reviewing a Procedure 169

Start Page Overview 68

Right-click Functionality 70

Starting a New Procedure 99

Routine Maintenance 424

Status Bar 73

Run Mode 165, 456 S

Stim Splitter 5

Safety Information

Stimulators 293, 299, 413

Stimulator Triggering 79

Operating Environments & Limits 388

Stimulus Intensity Adjustment 101

TCS-1 Warnings and Cautions 384

Stimulus Paramaters 154

Train Length Limit Warning 163

Stimulus Splitters 23

Warnings and Cautions 381

Stimulus Trigger Table 79

Saving Templates 380

Stimulus Triggering 100

Screens 213, 228, 235, 278

Store Image On 474

Search for Computer 348

Storing and Clearing Traces 162

Select Source 450

Summary Window 209

Set Baseline 110, 470

Summary Window Setup 254

Set Epoch Length 470

Sweep 445

Setting Baselines 110, 470

Sweep Delay 186

Setting Up Cursor Table 197

Sweep Speed 445

Setting Up Cursor Tables 197

Symbols 385

Setting up Trace Labels 199

Sync with Server 339

Setup Reject Info 194

System Key 48

Setup Thresholds 200

System Setup

486

Index Chat Tab 61

Inserting a Token into a Template 369

Colors Tab 63

Prompt/Option Token 374

Event Filtering Tab 62

Templates/Tokens 349

General Tab 58

Using Specialized Tokens 370

Remote Tab 60

Tokens 364

System Setup 48, 57, 68

Tool Bar 73

System Setup on the Remote Reader 336 T

Toolbar Description 74

TcEMEP 153

Trace Labels 199

TCS-1 33, 154, 165, 295, 397

Traces 162

TCS-1 Stimulator 295

Train Length Limit Warning 163

Template Editor 380

Transportation & Storage Limits 388

Templates

Troubleshooting 344

Editing Report Templates 357

toolbars 70

Inserting a Token into a Template 369

Turning Equipment On and Off 67 U

Inserting RTF/Bitmap Files 379

Unpacking the System 11, 33

Opening An Existing Template 356

Using a Page Header 359 V

Templates 349, 354, 355, 358, 359, 361, 373, 380

Verification of Proper Operation 387

Test Menu 135

Video Checks 300

Test Setup 284

Video Window 232

Third Party Software 332

View Menu 133

Threshold 140 Thresholds 200

View Windows 213, 228, 229, 232, 235, 278

Timer Intervals 285

Viewing a Procedure 169

TOF (Train of Four) Analysis Window 239

Views 339

TOF (Train of Four) Trace Window 236

VPN into LAN 322, 332

TOF Analysis Window 239

VPN to VPN setup 332 W

TOF Mode 475 TOF Mode Controls 475 TOF Window 236 Tokens Choice Token 367 Choices within Options 378 Comment Token 373

Visual Stimulators 300

Warranty 429 Waterfall Window 235, 278 Waveforms 78, 105, 477 Web Help 434 Window Descriptions Event Window 233 Live EEG Window 222 487

Elite Operators Manual Window Descriptions 70, 73

MEP Window Setup 246

Window Menu 137, 449

Mode Control Window Setup 241

Window Setup

Stacked EMG Window Setup 268

EMG Window Setup 245

Summary Window Setup 254

EP Analysis Window Setup 264

Window Setup 240

EP Average Window Setup 242 EP Cursor Trend Window Setup 260

Windows 98 vs Windows XP Professional 318

Event Window Setup 251

Working with Basic Windows 67

Global Summary Window Setup 280

Working with Cascade Windows 70

Global Waterfall Window Setup 282

Working with Cursors 109

Live EEG Window Setup 249

Working With Waveforms 78

Live Video Window Setup 263

488