Users Manual Part 1

1
Nerve Integrity Monitor
Table of Contents
Intended use 2
Indications for use 2
Device description 2
Contraindications 2
Warnings and precautions 2
Warnings ...........................................................................................................................................................................................2
Precautions ......................................................................................................................................................................................3
NIM quick monitoring set-up 4
The basics of what you will see and hear during monitoring .......................................................................................5
Unboxing and installing the system 5
Setting up the NIM Vital console .............................................................................................................................................6
Installing the NIM Vital battery
................................................................................................................................................. 6
Setting up the NIM Vital cart .....................................................................................................................................................6
Connecting NIM Vital accessories
............................................................................................................................................6
First time user interface setup ..................................................................................................................................................6
Set the time zone, date, time, and date/time format .......................................................................................................6
Create a surgeon prole
..............................................................................................................................................................7
Saving to a surgeon prole .............................................................................................................................................7
Save custom proles to a USB drive
............................................................................................................................7
Import custom proles from a USB drive ..................................................................................................................7
Components 8
Power Cords ................................................................................................................................................................................. 11
Software overview 11
Turning the system on .............................................................................................................................................................. 11
SETUP tab ...................................................................................................................................................................................... 11
Select user proles or default categories .......................................................................................................................... 13
Select a default procedure
........................................................................................................................................... 13
Select a user prole......................................................................................................................................................... 13
Connect Devices screen
................................................................................................................................................ 14
Check Electrode screen
................................................................................................................................................. 14
MONITORING tab
........................................................................................................................................................................ 15
EMG Display
....................................................................................................................................................................... 15
EMG display area ............................................................................................................................................................. 16
Recognizing stimulus artifacts
.................................................................................................................................... 16
Understanding and recognizing other artifacts
................................................................................................... 17
MONITORING tab right panel
...................................................................................................................................... 17
MONITORING tab Left panel
........................................................................................................................................ 18
NerveTrend (only available in select procedures) ................................................................................................20
NIM Vital bottom panel
................................................................................................................................................. 21
NIM Vital top panel
......................................................................................................................................................... 22
Settings overview
....................................................................................................................................................................... 26
Global settings
.................................................................................................................................................................. 26
Accessing settings ...........................................................................................................................................................26
Nervassure settings panel
............................................................................................................................................ 26
NerveTrend panel
............................................................................................................................................................ 27
Audio panel
...................................................................................................................................................................... 27
Display Settings panel
................................................................................................................................................... 28
Stimulation panel ............................................................................................................................................................ 30
Identify STIM 1 and STIM 2 types
............................................................................................................................... 31
Important note on stimulator adjustments
........................................................................................................... 32
Titles and comments
...................................................................................................................................................... 32
Optional features in monitoring
........................................................................................................................................... 33
Quick tags ........................................................................................................................................................................... 33
Probe-based functions
.................................................................................................................................................. 33
The REPORTS mode
................................................................................................................................................................... 35
Include quick tags on a report
.................................................................................................................................... 35
Delete quick tags from the report
............................................................................................................................. 35
Edit the snapshot title and comments.....................................................................................................................35
Include snapshots on a report .................................................................................................................................... 36
Edit sessions
...................................................................................................................................................................... 36
Include trending graphs in a report - Nervassure and NerveTrend .............................................................. 36
Edit case information on a report
.............................................................................................................................. 36
Generate the report ........................................................................................................................................................ 37
Nervassure overview ................................................................................................................................................................. 37
Nervassure case set up
.................................................................................................................................................. 37
Nervassure Monitoring Screen details ..................................................................................................................... 37
Monitoring a Nervassure case
.................................................................................................................................... 38
Thyroid with Nervassure specic features .............................................................................................................. 40
Muting a Nervassure alarm .......................................................................................................................................... 40
Default Nervassure alarm criteria
.............................................................................................................................. 41
Default Nervassure trend settings............................................................................................................................. 41
Audio – understanding what you hear
.............................................................................................................................. 43
Alarms .................................................................................................................................................................................. 43
Voices ................................................................................................................................................................................... 44
Tones
.................................................................................................................................................................................... 44
Other sounds .................................................................................................................................................................... 45
Powering down the NIM Vital system
................................................................................................................................. 45
Visual error and informational messages 45
System set-up 46
Operating room set-up .....................................................................................................................46
Anesthesia requirements .......................................................................................................46
Patient Interface setup ...................................................................................................................... 46
Stimulators ..................................................................................................................................47
Patient Interface box and stimulator combinations .................................................... 49
For installing the stimulating electrode ...................................................................................... 50
Surgery Notes ....................................................................................................................................... 51
After surgery ......................................................................................................................................... 51
When the case is complete .............................................................................................................. 51
When monitoring is complete ........................................................................................................51
Managing patient interface boxes 51
Power backup 51
General operation ............................................................................................................................... 51
Charging the patient interface box ..............................................................................................52
Loss of power during surgery ......................................................................................................... 52
Console battery charging
.................................................................................................................52
Using the console with no battery installed ..............................................................................52
Troubleshooting 52
Patient interface troubleshooting .................................................................................................54
Reprocessing and maintenance 54
Cleaning ..................................................................................................................................................54
Disinfection ...........................................................................................................................................55
Storage
.................................................................................................................................................... 55
Maintenance ......................................................................................................................................... 55
System self-tests .......................................................................................................................55
System quick check
................................................................................................................55
Annual planned maintenance ............................................................................................ 55
Annual system quick check
............................................................................................................. 55
Accessories 56
System description ............................................................................................................................. 56
Simulator set-up ..................................................................................................................................56
Use the patient simulator
.................................................................................................................57
Conrming electrodes ............................................................................................................57
Electrode lead o
.....................................................................................................................58
Stimulation
.................................................................................................................................59
External display support
...................................................................................................................61
Wireless display module
................................................................................................................... 61
NIM Vital Mute adapter (optional) .................................................................................................61
NIM Muting detector (optional)
.....................................................................................................61
Muting Detector setup
......................................................................................................................62
Additional mute probe adapter information
................................................................. 64
Muting
.......................................................................................................................................... 64
STIM Bur Guard ....................................................................................................................................64
Accessories / parts list
........................................................................................................................64
System components & accessories
.................................................................................... 64
Installing the optional power isolator
..........................................................................................65
NIM Probes and electrodes
..............................................................................................................66
Fuses......................................................................................................................................................... 68
Patient Interface fuse replacement
...............................................................................................69
Technical specications 70
NIM Vital Compatible Accessories ................................................................................................ 72
The NIM Vital equipment cart 73
NIM Vital lockdown ............................................................................................................................. 73
NIM Vital cart repair
............................................................................................................................ 73
Display default settings 75
STIM1 & 2 default settings 75
Legal information 76
Contact information ........................................................................................................................... 76
Open source software disclosure ..................................................................................................76
Guidance and manufacturer’s declaration – electromagnetic emission and immunity
....................................................................................................................................................................76
Limited warranty
................................................................................................................................. 78
Transmissible Spongiform Encephalopathies (TSE) ............................................................... 78
Glossary................................................................................................................................................... 79
Buttons and indicators
...................................................................................................................... 80
Symbols ..................................................................................................................................................84
FCC use only, not for Medical use