Users Manual
379 Pages
Preview
Page 1
®
NIM-ECLIPSE NS Neurophysiologist Supported NIOM
User’s Manual Software Version 3.5.350 December 2010 P/N 945NENUM Revision (C4)
i
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc.
Table of Contents 1
CUSTOMER SERVICE & LIMITED WARRANTY ... 1-1
1.1
Limited Warranty ... 1-1
2
PURPOSE OF THIS MANUAL ... 2-1
2.1
Who This Manual is for ... 2-1
3
INTRODUCTION ... 3-1
3.1
Device Description ... 3-1
3.2
Intended Use ... 3-1
3.3
Indications for Use ... 3-1
3.4
Neuromonitoring Applications... 3-1
3.5
CONTRAINDICATIONS ... 3-1
3.6
System Features ... 3-2
4
SAFETY CONSIDERATIONS AND USER RESPONSIBILITIES ... 4-1
4.1
Electro Surgical Unit (ESU) Safety Considerations for IOM ... 4-1
4.2
Additional Safety Information ... 4-1
4.3
Exceptions - System EMC Immunity Performance ... 4-2
4.4
User Responsibilities ... 4-2
5
WARNINGS AND CAUTION MESSAGES ... 5-1
5.1
Warnings ... 5-1
5.2 Precautions ... 5-3 5.2.1 Additional Precautions ... 5-4
6
SYSTEM ... 6-1
6.1
Overview ... 6-1
6.2
Components Check List ... 6-1
6.3
Unpacking the System ... 6-2
6.4
List of system accessories ... 6-3
7
COMPONENTS DESCRIPTION ... 7-1
7.1
Overview ... 7-1
7.2 Controller ... 7-1 7.2.1 Rear Panel... 7-1
ii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 7.3 System Computer ... 7-3 7.3.1 Desktop Computer Front Panel ... 7-4 7.3.2 Desktop Computer Rear Panel ... 7-5 7.3.3 External Monitor ... 7-7 7.3.4 Desktop Keyboard and Mouse ... 7-7 7.3.5 Portable Computer Component Description ... 7-7 7.4
Printer ... 7-11
7.5 Digital Preamplifier Module ... 7-11 7.5.1 Digital Preamplifier Remote Electrodes Connector ... 7-12 7.6
Pulse Oximeter ... 7-12
7.7
Digital Preamplifier Electrodes Extender ... 7-12
7.8 High Input Impedance Preamplifier ... 7-13 7.8.1 Installation ... 7-14 7.8.2 Operation ... 7-14 7.9
Electro-Surgery Unit Mute Probe ... 7-14
7.10 Electrical Stimulators ... 7-15 7.10.1 Stimulator Self-Tests ... 7-17 7.10.2 Stimulator Error Messages ... 7-17 7.10.3 Electrical Stimulator Impedance Error ... 7-18 7.11
Audio Stimulators ... 7-18
7.12
Visual Stimulators ... 7-18
7.13
External Trigger Outputs ... 7-19
7.14
External Speakers ... 7-19
7.15
Vital Signs Monitor ... 7-19
7.16
Microscope View or Video Camera Input ... 7-19
7.17 Remote Monitoring Connections ... 7-19 7.17.1 Modem ... 7-19 7.17.2 Network ... 7-20 7.18 TCD Module ... 7-20 7.18.1 Connecting the TCD Module ... 7-20 7.18.2 Standalone and Slave Modes ... 7-21 7.18.3 Using the TCD Module with NIM-Eclipse NS ... 7-21 7.19
TCD Fixation Headband... 7-22
8
INSTALLATION GUIDE ... 8-1
8.1
Site Selection ... 8-1
8.2
Main Connections ... 8-1
8.3
Peripheral and Stimulator Connections ... 8-1
8.4
External Connections ... 8-1
8.5
Applying Power ... 8-1
9
SYSTEM FUNCTIONS ... 9-1 iii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 9.1
User Interface Overview ... 9-1
9.2 Protocol Setup ... 9-1 9.2.1 Notebooks ... 9-1 9.2.2 Notebook Controls ... 9-1
10 QUICK START PROCEDURE ... 10-1 11 STARTING THE SYSTEM ... 11-1 11.1
Windows Logon ... 11-1
11.2
Startup Screen ... 11-1
11.3
Running in Simulation Mode ... 11-1
12 MAIN SCREEN ... 12-1 12.1
Title Bar ... 12-1
12.2
Status Line ... 12-1
12.3
Main Screen Installed Options ... 12-1
12.4 Main Screen Menu Bar ... 12-2 12.4.1 File ... 12-2 12.4.2 Calibrate ... 12-2 12.4.3 Help ... 12-4 12.5 Patients ... 12-6 12.5.1 Patient Folder ... 12-6 12.5.2 Patient Data List ... 12-6 12.5.3 Patient Screen Menu Bar ... 12-8 12.6 Standard Tests ... 12-15 12.6.1 Standard Test Screen Menu Bar ... 12-16 12.7 System Setup Notebook ... 12-19 12.7.1 General ... 12-19 12.7.2 Test ... 12-20 12.7.3 Vital Signs ... 12-23 12.7.4 Remote Monitoring ... 12-24 12.8
Support ... 12-24
13 SETTINGS NOTEBOOK... 13-1 13.1
Overview ... 13-1
13.2 Settings Notebook Pages ... 13-1 13.2.1 Settings Menu... 13-2 13.3 Electrodes and Channels ... 13-3 13.3.1 Overview... 13-3 13.3.2 Electrodes ... 13-4 13.3.3 Channels ... 13-5 13.4 Traces ... 13-6 13.4.1 Overview... 13-6 13.4.2 Trace Definition ... 13-8 iv
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 13.4.3 13.4.4 13.4.5 13.4.6 13.4.7 13.4.8 13.4.9 13.4.10
Area Name ... 13-10 Sweep Definition ... 13-11 Display SNS ... 13-11 Filters ... 13-11 Artifact/Threshold Settings ... 13-12 Trigger Group ... 13-13 EMG Audio Settings ... 13-13 Save ... 13-14
13.5 Sets ... 13-14 13.5.1 Overview... 13-14 13.5.2 Set Sequence ... 13-15 13.5.3 Advance Sets On ... 13-16 13.5.4 Stimulation ... 13-16 13.5.5 EP Building Average ... 13-16 13.5.6 Set Parameters ... 13-16 13.6 Stim Def ... 13-17 13.6.1 Overview... 13-17 13.6.2 Audio ... 13-18 13.6.3 LED Goggles ... 13-20 13.6.4 High Electrical 100mA/400V ... 13-21 13.6.5 TCeMEP ... 13-25 13.6.6 Pedicle Screw Integrity ... 13-28 13.6.7 Nerve Proximity ... 13-30 13.6.8 Low Electrical 4mA/4V... 13-32 13.6.9 External... 13-33 13.7 Stimulus Sequence... 13-34 13.7.1 Overview... 13-34 13.7.2 Set ... 13-37 13.7.3 Stimulation Mode ... 13-37 13.7.4 Trigger Source... 13-37 13.7.5 ASI Settings ... 13-38 13.7.6 Stimulus Sequence ... 13-38 13.8 EP Trace Markers ... 13-40 13.8.1 Overview... 13-40 13.8.2 Trace Markers ... 13-40 13.8.3 Interpeak Measurements ... 13-43 13.9
Comments ... 13-45
13.10 Stack ... 13-45 13.10.1 Overview... 13-45 13.10.2 Layout ... 13-46 13.10.3 Stack Parameters ... 13-47 13.10.4 Trend Selection ... 13-47 13.11 Spectra... 13-47 13.11.1 Overview... 13-47 13.11.2 Layout ... 13-48 13.11.3 Trend Selection ... 13-49 13.11.4 Bands ... 13-49 13.11.5 Spectral Parameters ... 13-49 13.11.6 Display ... 13-50 v
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 13.12 Trends ... 13-50 13.12.1 Overview... 13-50 13.12.2 Trends ... 13-51 13.12.3 Trend Layout ... 13-54 13.12.4 Timebase ... 13-55 13.12.5 Style ... 13-55 13.13
TCD ... 13-55
13.14 General ... 13-55 13.14.1 EP Averaging Mode ... 13-56 13.14.2 Stimulation ... 13-57 13.14.3 Running Index ... 13-57 13.14.4 Auto Save ... 13-58 13.14.5 Use TCD ... 13-59 13.14.6 Below Threshold Mute ... 13-59 13.14.7 Event Signaling ... 13-59 13.14.8 Comments ... 13-60 13.14.9 Vital Signs Monitor ... 13-60 13.15
Exiting the Settings Notebook ... 13-60
13.16
Settings Files ... 13-60
14 RUNTIME DISPLAY ... 14-1 14.1
Overview ... 14-1
14.2
Title Bar ... 14-2
14.3 Control Bar ... 14-2 14.3.1 Test ... 14-3 14.3.2 Start/Stop ... 14-3 14.3.3 Pause/Resume ... 14-3 14.3.4 Live ... 14-3 14.3.5 Electrodes ... 14-4 14.3.6 Stimulation (Stim) ... 14-6 14.3.7 Speaker ... 14-7 14.3.8 Next Average (NextAvg) ... 14-7 14.3.9 Baseline (Bsl) ... 14-7 14.3.10 Reset EP ... 14-8 14.3.11 Save ... 14-9 14.3.12 Save Test Settings ... 14-11 14.3.13 Print ... 14-11 14.3.14 Settings ... 14-12 14.3.15 Review ... 14-12 14.3.16 Patient Info ... 14-13 14.3.17 Report Workbook ... 14-13 14.3.18 Remote Monitoring ... 14-13 14.3.19 Live Chat ... 14-13 14.3.20 Close ... 14-14 14.4 Sets ... 14-14 14.4.1 Allow Individual Screen Layouts ... 14-15 14.5 Window ... 14-15 14.5.1 Primary (Main) Window Display Options ... 14-15 vi
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 14.5.2 14.5.3 14.5.4 14.5.5
Secondary Window Display Options ... 14-15 Expand Display... 14-16 Dual Screen ... 14-16 Background Colors ... 14-16
14.6
Cursors ... 14-18
14.7
Help ... 14-18
14.8
Runtime Status Bar ... 14-18
14.9
Keyboard Control... 14-20
15 DATA PRESENTATION DISPLAY ... 15-1 15.1
Overview ... 15-1
15.2 Window Presentation Options ... 15-2 15.2.1 Resizing Windows ... 15-3 15.3 Trace Window... 15-3 15.3.1 Moving Traces ... 15-5 15.3.2 EEG Trace Area ... 15-5 15.3.3 EMG Trace Area ... 15-5 15.3.4 Signal Triggered Trace Area ... 15-6 15.3.5 Evoked Potential (EP) Trace Area ... 15-7 15.4 Stack Window ... 15-8 15.4.1 Scrolling Stack Traces ... 15-9 15.4.2 Selecting Stack Traces... 15-9 15.4.3 Hiding Stack Traces ... 15-9 15.4.4 Zooming a Stack Column ... 15-9 15.4.5 Stack Trace Markers ... 15-9 15.5
Spectral Window ... 15-10
15.6
Trend Window ... 15-11
15.7 Numeric Window ... 15-12 15.7.1 Numeric EEG ... 15-12 15.7.2 Numeric EP ... 15-14 15.7.3 Numeric Trends ... 15-15 15.8 Cursors ... 15-17 15.8.1 Single and Dual Cursors ... 15-17 15.8.2 Latency Cursor ... 15-18 15.9
EP Trace Markers ... 15-18
15.10 TCD Window ... 15-22 15.10.1 TCD Enabled Tests ... 15-22 15.10.2 TCD Measurements ... 15-23 15.11 Secondary Window ... 15-23 15.11.1 Current Value Window ... 15-24 15.11.2 Comment History Window ... 15-25 15.11.3 Measured Current ... 15-27 15.11.4 Vital Signs ... 15-27 15.11.5 Numeric MER Spikes ... 15-27 15.11.6 Numeric EP Markers ... 15-28 vii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 15.11.7 15.11.8 15.12
Numeric TCD ... 15-28 Video... 15-28
Dual Screen ... 15-30
15.13 Pedicle Screw Integrity Test ... 15-32 15.13.1 Running the Test ... 15-33 15.14 Train of 4 (TOF) Test ... 15-33 15.14.1 TOF Technique ... 15-34
16 RUNTIME NOTEBOOK... 16-1 16.1
Overview ... 16-1
16.2 Channels ... 16-1 16.2.1 Set Name ... 16-2 16.2.2 FSI ... 16-2 16.2.3 Reset Amplifiers... 16-2 16.3 Trace Parameters Overview ... 16-2 16.3.1 Trace Names ... 16-3 16.3.2 Trace On ... 16-3 16.3.3 Inv (Trace) ... 16-3 16.4 EEG Traces ... 16-3 16.4.1 SNS... 16-4 16.4.2 Timebase ... 16-4 16.4.3 Artifact Rejection ... 16-4 16.4.4 Filters ... 16-5 16.4.5 Apply ... 16-5 16.5 EMG Traces ... 16-5 16.5.1 SNS... 16-6 16.5.2 Timebase ... 16-6 16.5.3 Audio Threshold ... 16-6 16.5.4 Filters ... 16-6 16.5.5 Audible ... 16-7 16.5.6 Apply ... 16-7 16.5.7 Mute Audio Above... 16-7 16.5.8 MER thresholds ... 16-7 16.6 EP Traces ... 16-8 16.6.1 SNS... 16-8 16.6.2 Artifact Rejection ... 16-9 16.6.3 Filters ... 16-9 16.6.4 Timebase ... 16-10 16.6.5 Sweeps... 16-10 16.6.6 Avg Filter ... 16-10 16.6.7 Apply ... 16-10 16.6.8 Notch ... 16-11 16.6.9 Marker ... 16-11 16.7 Signal Trigger Trace ... 16-11 16.7.1 SNS... 16-12 16.7.2 Timebase ... 16-12 16.7.3 Signal Trigger Threshold ... 16-12
viii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 16.7.4 16.8
Apply ... 16-13
Trace Area Overview ... 16-13
16.9 EEG and EMG Modalities ... 16-13 16.9.1 Zoom... 16-14 16.9.2 Horiz and Vert Split ... 16-14 16.10 Sig Trig Modality ... 16-14 16.10.1 Zoom ... 16-15 16.10.2 Horiz and Vert Split ... 16-15 16.11 EP Modality... 16-15 16.11.1 Text Display Options ... 16-16 16.11.2 Graphics Display Options ... 16-16 16.11.3 Markers ... 16-17 16.11.4 Marker Display... 16-17 16.11.5 EP View ... 16-17 16.11.6 Mini Stack Parameters ... 16-18 16.11.7 Zoom ... 16-19 16.11.8 Horiz and Vert Split ... 16-19 16.12 Sets ... 16-19 16.12.1 Set Name ... 16-20 16.12.2 Set Sequence ... 16-20 16.13
Stimulus Overview ... 16-20
16.14 Audio ... 16-21 16.14.1 Mode ... 16-21 16.14.2 Type ... 16-21 16.14.3 Polarity ... 16-21 16.14.4 Pulse ... 16-22 16.14.5 ASI ... 16-22 16.14.6 Stim Rate ... 16-22 16.14.7 Stimulus Intensity ... 16-22 16.14.8 Noise ... 16-23 16.14.9 Duration ... 16-23 16.14.10 Frequency ... 16-23 16.15 Goggles ... 16-23 16.15.1 Mode ... 16-24 16.15.2 Pulse ... 16-24 16.15.3 ASI ... 16-25 16.15.4 Stim Rate ... 16-25 16.15.5 Duration ... 16-25 16.15.6 Intensity ... 16-25 16.16
High Electrical 100mA/400V Overview ... 16-25
16.17 High Electrical Intensity Page ... 16-25 16.17.1 Duration ... 16-26 16.17.2 Intensity Slider ... 16-26 16.17.3 Measured Intensity... 16-27 16.18 High Electrical Parameters Page ... 16-27 16.18.1 Mode ... 16-27 16.18.2 Type ... 16-28 ix
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 16.18.3 16.18.4 16.18.5 16.18.6 16.18.7 16.18.8 16.19
Polarity ... 16-28 Pulse ... 16-28 ASI ... 16-28 Stim Rate ... 16-29 Stim Module ... 16-29 Output 1 and Output 2 ... 16-29
TCeMEP Overview ... 16-29
16.20 TCeMEP Parameters Page ... 16-30 16.20.1 Type ... 16-30 16.20.2 Mode ... 16-30 16.20.3 Polarity ... 16-30 16.20.4 Pulse ... 16-30 16.20.5 Stim Rate ... 16-31 16.20.6 ASI ... 16-32 16.20.7 Stim Module ... 16-32 16.20.8 Output 1 ... 16-32 16.21 TCeMEP Intensity Page ... 16-32 16.21.1 Duration ... 16-32 16.21.2 Intensity Slider ... 16-32 16.21.3 Measured Intensity... 16-33 16.21.4 Link Intensity ... 16-33 16.22 Low Electrical (4mA/4V) ... 16-33 16.22.1 Type ... 16-34 16.22.2 Polarity ... 16-34 16.22.3 Pulse ... 16-34 16.22.4 ASI ... 16-35 16.22.5 Stim Rate ... 16-35 16.22.6 Stim Module ... 16-35 16.22.7 Duration ... 16-35 16.22.8 Intensity Slider ... 16-35 16.22.9 Measured Intensity... 16-35 16.22.10 Tone Volume ... 16-36 16.23
Pedicle Screw Integrity Overview ... 16-36
16.24 Pedicle Screw Integrity Intensity Page ... 16-36 16.24.1 Duration ... 16-36 16.24.2 Intensity Slider ... 16-36 16.24.3 Auto Test ... 16-37 16.24.4 Audio Status Indicators... 16-37 16.24.5 Volume ... 16-38 16.24.6 Mute ... 16-38 16.25 Pedicle Screw Integrity Parameters Page ... 16-38 16.25.1 Rate ... 16-39 16.25.2 Output 1 ... 16-39 16.26
Nerve Proximity Overview ... 16-39
16.27 Nerve Proximity Test Parameters ... 16-39 16.27.1 Duration ... 16-40 16.27.2 Measured Intensity... 16-40 16.27.3 Max Intensity ... 16-40 x
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 16.27.4 16.27.5 16.27.6 16.27.7 16.27.8 16.27.9
Start time ... 16-40 End time ... 16-40 Response Threshold ... 16-40 Tone Threshold Low/High ... 16-41 Volume ... 16-41 Mute ... 16-41
16.28 Nerve Proximity Parameters Page... 16-41 16.28.1 ASI ... 16-41 16.28.2 Stim Rate ... 16-42 16.28.3 Output 1 ... 16-42 16.29 External Stimulation Overview ... 16-42 16.29.1 Mode ... 16-42 16.29.2 Pulse ... 16-43 16.29.3 ASI ... 16-43 16.29.4 Stim Rate ... 16-43 16.29.5 Duration ... 16-43 16.30
Stimulus Sequence Overview ... 16-43
16.31 Stimulus Sequence Intensity ... 16-44 16.31.1 Stimulus Names ... 16-44 16.31.2 Intens Left ... 16-44 16.31.3 Units ... 16-44 16.31.4 Intens Right ... 16-44 16.31.5 All ... 16-44 16.31.6 Suppress Stim. Artifact ... 16-45 16.32 Stimulus Sequence, ASI / Stim Rate ... 16-45 16.32.1 Stimulus Names ... 16-45 16.32.2 ASI ... 16-45 16.32.3 Stim Rate ... 16-46 16.32.4 Stim Mode ... 16-46 16.32.5 Interval ... 16-46 16.32.6 Pause on Stop ... 16-46 16.32.7 Stimulus Gating ... 16-47 16.33 Signal Trigger Overview ... 16-47 16.33.1 Trigger Source ... 16-47 16.33.2 Trace Name ... 16-48 16.33.3 Threshold Trigger Level ... 16-48 16.33.4 Start ... 16-48 16.33.5 All ... 16-48 16.33.6 Tone ... 16-48 16.34 Stack ... 16-48 16.34.1 Area Name ... 16-49 16.34.2 SNS ... 16-49 16.34.3 All ... 16-49 16.34.4 Timebase ... 16-49 16.34.5 Update Rate ... 16-50 16.34.6 Space ... 16-50 16.34.7 Display Lat/Ampl as ... 16-50 16.34.8 Trends ... 16-50 16.34.9 Stim.Curr. ... 16-50 xi
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 16.34.10 16.34.11
Bsl (Baseline) ... 16-50 Mkr (Markers)... 16-50
16.35 Spectra... 16-51 16.35.1 Display Mode ... 16-51 16.35.2 Display Type... 16-51 16.35.3 Spectral Edge ... 16-51 16.35.4 Display Frequency Range ... 16-51 16.35.5 Space ... 16-52 16.35.6 Scale... 16-52 16.35.7 Update Rate ... 16-52 16.35.8 FFT Avg Time... 16-52 16.35.9 Measurement ... 16-52 16.35.10 Baseline ... 16-53 16.35.11 Trends ... 16-53 16.36 Trend ... 16-53 16.36.1 Trend Name ... 16-53 16.36.2 Mode ... 16-54 16.36.3 Reference ... 16-54 16.36.4 Scale... 16-54 16.36.5 Low Threshold ... 16-54 16.36.6 High Threshold... 16-54 16.36.7 Trend Display Parameters ... 16-54 16.36.8 Timebase ... 16-55 16.36.9 Style ... 16-55 16.36.10 Event Tone ... 16-55 16.37 Speaker ... 16-55 16.37.1 EMG Traces ... 16-56 16.37.2 Mute Trace ... 16-56 16.37.3 Audio Output ... 16-56 16.37.4 Mute Stimulus Artifact ... 16-56 16.37.5 Below Threshold Mute ... 16-57 16.37.6 Volume ... 16-57 16.37.7 Mute ... 16-57 16.38 TCD Settings ... 16-57 16.38.1 Vessel ... 16-58 16.38.2 Depth ... 16-58 16.38.3 Power... 16-58 16.38.4 Gain ... 16-58 16.38.5 Scale... 16-58 16.38.6 Baseline ... 16-59 16.38.7 Sweep ... 16-59 16.38.8 Wall Filter ... 16-59 16.38.9 Gate ... 16-59 16.38.10 Audio Vol ... 16-59 16.38.11 Audio ... 16-59 16.38.12 Envelope ... 16-59 16.38.13 Invert ... 16-59 16.38.14 Spectral gain ... 16-60 16.38.15 Alias ... 16-60 16.38.16 Max V/F ... 16-61
xii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 16.38.17
High PRF... 16-61
16.39 Autosave ... 16-61 16.39.1 EEG ... 16-62 16.39.2 TCD ... 16-62 16.39.3 EP ... 16-62 16.39.4 Video 1, Video 2... 16-62 16.39.5 Sig Trig ... 16-62 16.39.6 Free Run EMG ... 16-62 16.39.7 EMG Audio ... 16-62 16.39.8 Save on Event ... 16-63
17 REVIEWING DATA ... 17-1 17.1
Overview ... 17-1
17.2
Selecting Patient Data for Review ... 17-1
17.3
Review Control Button Bar ... 17-2
17.4 Menu ... 17-2 17.4.1 Test ... 17-2 17.4.2 Sets ... 17-7 17.4.3 View ... 17-7 17.4.4 Window ... 17-9 17.4.5 Cursors ... 17-11 17.4.6 Help ... 17-11 17.5
MoveTo Bar ... 17-11
17.6
Review Notebook ... 17-11
17.7
Modifying EP Trace Marker Settings ... 17-12
18 PRINTING TEST DATA REPORTS ... 18-1 18.1
Overview ... 18-1
18.2 Print Report Dialog ... 18-1 18.2.1 Printer ... 18-1 18.2.2 Printer Properties ... 18-1 18.2.3 Save to HTML format ... 18-1 18.2.4 Save to HL7 format ... 18-2 18.2.5 Comment ... 18-2 18.2.6 Report Details ... 18-2 18.2.7 Fast Print Screen Output Selection ... 18-3 18.2.8 Patient Privacy and HIPAA Compliance ... 18-3 18.2.9 Print Report ... 18-3 18.2.10 Print Screen ... 18-3 18.2.11 Cancel ... 18-4 18.3
Sending Reports by Fax ... 18-4
18.4 Printing Reports to a File ... 18-4 18.4.1 Creating a PDF Report ... 18-4
19 REPORT GENERATOR ... 19-1
xiii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 19.1
Templates ... 19-1
19.2
Lists ... 19-2
19.3
Editing Lists ... 19-2
19.4
Printing ... 19-3
19.5
Saving the Report ... 19-3
19.6
Formatting Text ... 19-4
19.7
Using Tables... 19-4
19.8
Example: Text Layout Using Tables ... 19-5
19.9
Creating and Editing Templates ... 19-5
19.10
Adding Data Fields ... 19-7
20 REMOTE MONITORING ... 20-1 20.1 Overview ... 20-1 20.1.1 Screen Image Transfers ... 20-1 20.1.2 Direct File Sharing ... 20-1 20.1.3 File Sharing Using a Server ... 20-1 20.2 Remote monitoring parameters ... 20-1 20.2.1 Remote Monitoring by Screen Transfer ... 20-2 20.2.2 Remote Monitoring by Data Sharing ... 20-5 20.2.3 Settings ... 20-6 20.3 NIOM Explorer ... 20-6 20.3.1 Opening NIOM Explorer ... 20-6 20.3.2 Using the NIOM Explorer ... 20-7 20.3.3 Setting up the NIOM Explorer ... 20-8 20.4
Open Patient Data For Review Immedialtely ... 20-9
21 EXPORT ASCII DATA ... 21-1 21.1
Overview ... 21-1
21.2 Select Data... 21-1 21.2.1 Trend Data ... 21-2 21.2.2 EP Stack Markers ... 21-2 21.2.3 EP Traces... 21-2 21.2.4 SigTrig Traces ... 21-2 21.2.5 EEG Traces ... 21-2 21.2.6 EEG Spectra ... 21-3 21.2.7 EMG Traces ... 21-3 21.2.8 Include Patient Data ... 21-3 21.2.9 Missing Data Value ... 21-3 21.2.10 Export to ... 21-3 21.3 Exported ASCII Data Format ... 21-4 21.3.1 Header Information ... 21-4 21.3.2 EP Sweep Data ... 21-4 21.3.3 EP Stack Markers Data ... 21-4 21.3.4 SigTrig Sweep Data ... 21-5
xiv
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 21.3.5 21.3.6 21.3.7 21.3.8
Trend Data ... 21-5 EEG Raw Data ... 21-5 EEG Spectral Data ... 21-6 EMG Data... 21-6
22 MAINTENANCE ... 22-1 22.1
Maintenance Schedule ... 22-1
22.2
Equipment Inspection Guidelines ... 22-1
22.3
Equipment Cleaning ... 22-2
22.4
Cables, Leadwires and Electrodes ... 22-2
22.5
Equipment Transportation ... 22-2
23 APPENDIX 1 – DOPPLER PRINCIPLES AND OPERATION... 23-1 23.1
The Doppler Effect ... 23-1
23.2
Pulsed Wave Doppler ... 23-1
23.3
Doppler Signal Quality ... 23-3
23.4 TCD Clinical Exam... 23-4 23.4.1 Basic Concepts ... 23-4 23.4.2 Examination Guide ... 23-6
24 APPENDIX 2 – REMOTE MONITORING SETUP ... 24-1 24.1 Remote Monitoring Setup Using NetOp ... 24-1 24.1.1 Via Modem ... 24-1 24.1.2 Via LAN with Guest and Host in Same LAN Segment ... 24-1 24.1.3 Via LAN with Guest and Host in Different LAN Segments ... 24-1 24.1.4 Via Internet ... 24-5 24.2 Remote Monitoring Setup Using a Shared Folder ... 24-8 24.2.1 File and Printer Sharing ... 24-8 24.2.2 Folder Sharing ... 24-8 24.3
System Wireless LAN connectivity ... 24-8
25 APPENDIX 3 – IMPORTING VITAL SIGNS VIA DATACAPTOR ... 25-1 25.1
DataCaptor Activation ... 25-1
25.2
Monitoring Vital Signs ... 25-2
26 APPENDIX 4 – HIPAA COMPLIANCE... 26-1 26.1
Overview ... 26-1
26.2 Windows System ... 26-1 26.2.1 Changing the Windows Password ... 26-1 26.3 Third Party Software ... 26-2 26.3.1 NetOp Remote Monitoring ... 26-2 26.3.2 PDF Printing ... 26-3 26.4
®
NIM ECLIPSE NS Application ... 26-3 xv
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 26.4.1 26.4.2 26.4.3 26.4.4 26.4.5 26.4.6 26.4.7 26.4.8
®
NIM ECLIPSE NS System Password Access ... 26-4 Encryption/Decryption of Patient Data ... 26-6 Copying Patient Data Security ... 26-7 Hide Patient Name When Running/Reviewing a Test ... 26-7 Report Security ... 26-7 Export Patient Data Security ... 26-8 Edit Legal Notice ... 26-8 Security Log File ... 26-8
27 APPENDIX 5– NIM-ECLIPSE® NS FILES ... 27-1 27.1
Program Files ... 27-1
27.2
Server Program Files for Data sharing ... 27-1
27.3
Standard Test Files ... 27-1
27.4
Patient Data Files ... 27-1
27.5
HTML Report Files ... 27-1
27.6
HL7 Report Files ... 27-1
27.7
Export ASCII Files ... 27-2
27.8
NIM-ECLIPSE NS Setup Files ... 27-2
27.9
Log Files ... 27-2
®
28 APPENDIX–6 - TROUBLESHOOTING ... 28-1 29 APPENDIX–7 - ARTIFACTS ... 29-1 29.1
Overview ... 29-1
29.2 Artifact Sources ... 29-1 29.2.1 Electrodes and Leads ... 29-1 29.2.2 Physiological Artifacts... 29-1 29.2.3 Environmental Artifacts ... 29-2 29.3 Artifact Recognition and Correction ... 29-2 29.3.1 EEG Mode ... 29-2 29.3.2 EP Mode ... 29-2 29.3.3 Artifact Types... 29-3
30 APPENDIX–8 - ABBREVIATIONS AND SYMBOLS ... 30-1 30.1
Abbreviations ... 30-1
30.2
Symbols ... 30-3
31 APPENDIX 9 - SPECIFICATIONS ... 31-1 32 APPENDIX 10 – DECLARATION OF ELECTROMAGNETIC IMMUNITY ... 32-1 33 APPENDIX 11 - GLOSSARY ... 33-3
xvi
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc.
Disclaimer Information in this document is subject to change without notice. Names and data used in examples included herein are fictitious unless otherwise noted. No part of this document may be reproduced in any manner, or transmitted by any form or means electronic or mechanical, for any purpose without the express written permission of Medtronic. Medtronic makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. Medtronic assumes no responsibility for any errors that may appear in this document and we make no commitment to update or keep current the information contained in this document.
© 2010 Medtronic Xomed, Inc. All rights reserved.
xvii
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc.
1
CUSTOMER SERVICE & LIMITED WARRANTY
US CUSTOMER SERVICE INTERNATIONAL CUSTOMER SERVICE U.S. Customer Service Medtronic Sofamor Danek USA General customer service and technical support are available toll-free: Phone: 800-933-2635 Fax: 800-468-9705 Monday - Friday 7:00 a.m. - 7:00 p.m. CST Microelectronics Repair International customers should contact their local Medtronic Sofamor Danek USA Medtronic Xomed office. Technical Support: 800-933-2635 Fax: 800-468-9705 Monday - Friday 7:00 a.m. - 7:00 p.m. CST Return Address: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132, USA Attn.: Repair Department ® The NIM-ECLIPSE NS System Helpline Medtronic Sofamor Danek USA Should you need immediate help with a technical question or guidance through the appropriate ® protocol, just call the NIM-ECLIPSE NS System Help Line at 800-933-2635.
NOTE: When contacting our Customer Service and Technical Support, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available.
1.1
LIMITED WARRANTY ®
A.
This LIMITED WARRANTY provides assurance for the customer who purchases a NIM-ECLIPSE System (hereinafter the “Product”) that should the Product fail to function to Medtronic published specifications during the term of this LIMITED WARRANTY (one year from the date of shipment or 90 days from the date of sale of a refurbished or used System Component), Medtronic will either replace, repair, or issue a credit (adjusted to reflect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Medtronic or from its affiliate or its authorized distributor or representative.
B.
To qualify for this LIMITED WARRANTY, the following conditions must be met: (1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable. (2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. (3) Medtronic must be notified in writing within thirty (30) days following discovery of a defect.
1-1
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc.
(4) The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. (5) Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product. C.
This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.
D.
The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. Caution
Applicable law may restrict the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner.
1-2
®
Manufactured by: Medtronic Xomed, Inc. NIM-ECLIPSE NS System User’s Manual, Version 3.5.350 In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc.
Manufactured by: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone: (800)-874-5797 / (904)-296-9600
In the USA: Distributed by: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132, USA Telephone: 800-933-2635 (in USA) 800-876-3133 (in USA) Fax: 901-396-0356 (in USA)
EU Authorized Representative: Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel: +31 45 566 80 00
Trademarks ®
NIM-ECLIPSE System is a registered trademark of Medtronic, Inc. Microsoft is a registered trademark of Microsoft Corporation. TM
Windows
is a trademark of Microsoft Corporation.
NetOp is a registered trademark of DanWare Corp.
1-3