Medtronic NIM-Response 3.0, NIM-Neuro 3.0 User Manual

Nerve Integrity Monitor

Monitoring

Information

5/1/2009 9:00 AM

NIM-Response 3.0

1. Select Procedure

Neuro/Otology

Custom Procedures

* indicates default settings have been changed

Setup

Step 1 of 2

Head/Neck

Peripheral

NIM-Response® 3.0

Reports

NI M-R es po nse ® 3. 0

Global

Settings

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Help

1. Select Procedure

Setup

Step 1 of 2

Neuro/Otology

Head/Neck

Peripheral

Custom Procedures

Monitoring

Information

Reports

NI M-N eu ro ® 3 .0

User’s Guide

* indicates default settings have been changed

5/1/2009 9:00 AM

NIM-Neuro 3.0

NIM-Neuro® 3.0

Global

Help

Global

Help

Settings

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Rx Only

MEDTRONIC XOMED INC. 6743 Southpoint Drive North

Jacksonville, FL 32216 USA

™ are trademarks and ® are registered marks of Medtronic Xomed, Inc.

HP DeskJet™ is a trademark of Hewlett Packard Company

Released documents are available for viewing/printing @ manuals.medtronic.com

e information contained in this document was accurate at time of publication. Medtronic reserves the right to make changes in the product

described in this manual without notice and without incorporating those changes in any products already sold.

Contents

Contents ......................................................................................3

Denitions (used in this manual) ...........................................4

Warnings and Precautions .......................................................4

Warnings ...........................................................................................4

System Warnings .........................................................................4

Precautions ........................................................................................4

Symbols ....................................................................................... 5

Buttons and Indicators ............................................................. 6

When the System Arrives ......................................................... 7

Unpacking and Inspection .........................................................7

Soware ........................................................................................7

System Description ...................................................................7

Device Description ..........................................................................7

Indications for Use ...........................................................................7

Contraindications ............................................................................7

Customer Care ........................................................................... 7

Medtronic Xomed, Inc. ..................................................................7

Help Line ......................................................................................7

International Service ..................................................................7

Components ............................................................................... 7

Console Front ...................................................................................7

Console Le Side ..............................................................................7

Console Rear .....................................................................................8

Patient Interface................................................................................8

Patient Simulator ..............................................................................8

Stimulator Probes/Handles .............................................................8

Monopolar ...................................................................................8

Bipolar ..........................................................................................9

Muting Detector ...............................................................................9

APS™ Electrode Handswitch ...........................................................9

Electrodes ..........................................................................................9

Power Cords ......................................................................................9

e Splash Screen .............................................................................10

Self Test .........................................................................................10

Set‑Up Mode .............................................................................. 10

Select Procedure Step 1 of 2 .......................................................10

Global Settings ..................................................................................10

Help ....................................................................................................10

Electrode Check ...............................................................................11

Electrode Check Panel ...............................................................11

Electrode Check Panel Pass/Fail ...............................................11

Electrode Check Show Details Panel ........................................12

Electrode Type Panel ..................................................................12

Electrode Troubleshooting Guide .............................................12

Case Information .............................................................................12

Procedure Settings Panel .................................................................12

Advanced Settings ............................................................................13

Audio Tab .....................................................................................13

Monitoring Tab ...........................................................................13

Stimulation Tab ...........................................................................14

Microscope Tab (available on the NIM‑Neuro® 3.0 only) ....15

Monitoring Mode ...................................................................... 16

Control Panel ....................................................................................16

e APS™ Monitoring Screen .........................................................17

e Reports Mode ..................................................................... 18

Reports Step 1 of 3 (Select Report Format) ..................................18

Snapshots/Event Reports ...........................................................18

Choose Report Content Step 2 of 3 ...............................................18

Snapshots/Events Reports Step 3 of 3 ............................................18

Snapshots/Events Reports .pdf Image Example .....................19

Log Files.............................................................................................19

Log Files Step 1 of 3 See Reports Step 1 of 3 ...............................19

Log Files Step 2 of 3 .........................................................................19

Log Files Step 3 of 3 .........................................................................19

Log Reports pdf Image Example ...............................................20

Log Reports .csv (in Excel) Example ........................................20

APS™ Reports ....................................................................................20

APS™ Reports .pdf Image Example ...........................................20

Creating a Report .............................................................................20

Snapshots Report ........................................................................20

Log les ..............................................................................................21

Special Functions and Features ...............................................21

Visual Alarms and Warnings ..........................................................21

Audio – Understanding What You Hear .......................................22

Alarms ..........................................................................................22

Stimulus Delivery Audio ............................................................22

Nerve Integrity Monitor

Muting .........................................................................................22

Muting Conditions .....................................................................22

STIM Bur Guard .........................................................................23

System Set‑Up ............................................................................ 23

Operating Room Set‑Up .................................................................23

Typical Set‑Up (shown with IPC®) ...........................................23

Anesthesia Requirements ..........................................................23

Muting Detector Set‑Up ..................................................................23

Patient Interface Set‑Up............................................................24

Patient Interface and Single Stimulators ......................................24

Monopolar Incrementing Probe ...............................................24

Monopolar Probe with Universal Handle................................24

Bipolar Probe ...............................................................................25

APS™ Electrode Stimulator ........................................................25

Patient Interface and Stimulator Combinations ..........................25

Monopolar Incrementing Stimulator and APS™ Electrode

Stimulator.....................................................................................25

Monopolar Probe and Stimulus Dissection Probe .................26

Bipolar and Monopolar Probe ..................................................26

Monitor Set‑Up .......................................................................... 26

Basic Set‑Up All Procedures ...........................................................26

Standard Set‑Up ...............................................................................26

Custom Set‑Up .................................................................................26

Additional Settings ...........................................................................27

For Installing the Stimulating Electrode ..................................27

APS™ Monitoring .............................................................................27

Changing APS™ Settings ............................................................27

Surgery Notes ..............................................................................27

Aer Surgery .....................................................................................27

When the Case is Complete ............................................................27

When Monitoring is Complete ......................................................27

Power Disconnection .................................................................27

Cleaning and Maintenance ......................................................27

Cleaning (aer each use) ..........................................................27

Storage ..........................................................................................27

Maintenance ................................................................................27

Fuses ...................................................................................................28

Console Replacement .................................................................28

Patient Interface Replacement...................................................29

Troubleshooting .........................................................................30

Technical Specications .......................................................... 31

Appendix A Accessories / Parts List ....................................... 33

System Components & Accessories ..........................................33

Appendix B Annual System Quick Check .............................34

Preventive and Corrective Maintenance ..................................34

Appendix C Patient Simulator Instructions for Use .............35

Introduction ......................................................................................35

System description ...........................................................................35

System Set‑Up ...................................................................................35

Simulator Set‑Up .........................................................................35

System Assessment ...........................................................................35

Conrming Electrodes ...............................................................35

Electrode Lead O ......................................................................36

Stimulation ........................................................................................36

Mechanical Stimulation .............................................................36

Stimulus: Set and Measure .........................................................36

reshold Test ............................................................................37

Cleaning .......................................................................................37

Storage ..........................................................................................37

Troubleshooting .........................................................................37

Appendix D e NIM® 3.0 Equipment Cart ...................................38

Uncrating ...........................................................................................38

NIM® 3.0 Tether ................................................................................38

Appendix E Default Tables ...............................................................39

Channel Default Settings ...........................................................39

Display Default Settings .............................................................40

STIM1 & 2 Default Settings ......................................................40

Microscope Default Settings ......................................................40

Appendix F Electromagnetic Immunity ..........................................41

Guidance and manufacturer’s declaration – electromagnetic

immunity ‑ Part I .............................................................................41

Part II .................................................................................................42

Limited Warranty ......................................................................43

Denitions (used in this manual)

FCU Foot Control Unit. APS™ Automatic Periodic Stimulation. NIM® Nerve Integrity Monitor. NIM® 3.0 NIM‑Neuro® 3.0 or the NIM‑Response® 3.0 Event Sequence A sequence is dened as a series of events

Stimulus Rejection Period

GUI Graphic User Interface. DSP Digital Signal Processor.

separated from each other by less than one second. Adjustable delay reading EMG aer stimulation. In previous versions of the NIM, this was referred to as Stimulus Artifact or Artifact Delay.

Warnings and Precautions

It is important that the NIM‑Neuro® 3.0 and NIM‑ Response® 3.0 intended operators be familiar with this manual: its Warnings, Precautions, procedures and safety issues. Disregarding the information on safety is considered abnormal use.

Warnings

System Warnings

W1. Aer each procedure, properly clean and disinfect all reusable

system components.

W2. To avoid the risk of re or explosion, do not use the NIM® System

in the presence of ammable anesthetics and/or oxygen rich environment.

W3. Disconnect power to the NIM‑Neuro®/Response® 3.0 Console

before cleaning the unit to avoid electrical macro shock.

W4. Achieve electrical grounding reliability with proper connections.

Connect the NIM‑Neuro®/Response® 3.0 Console to hospital grade receptacles only.

W5. DO NOT use any parts other than Medtronic Xomed, Inc.

components as damage or substandard performance could result.

W6. is medical device complies with IEC/EN60601‑1‑2 safety

standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.

W7. It is important that the NIM‑Neuro®/Response® 3.0 operator be

familiar with this manual, its precautions, procedures and safety issues.

W8. To avoid electrical shock, do not attach unapproved components

or accessories to the NIM® System.

W9. All service must be performed by Medtronic qualied personnel

only.

W10. To avoid patient burns:

a. Do not activate the electrosurgical instruments while

stimulator is in contact with tissue. b. Do not leave stimulating electrodes or probes in surgical eld. c. Do not store stimulating electrodes or probes in

electrosurgical instrument holder. d. Do not allow a second surgeon to use electrosurgical

W11. Direct stimulator contact may disrupt the operation of active

W12. Electrocardiogram monitoring artifacts may be caused by

W13. Use of unapproved stimulators, stimulus probes, stimulus

W14. Repair and/or modication to the NIM® or any accessory by

instruments while stimulator is in use.

implanted devices. Consult medical specialist before use.

NIM® stimulus current delivery or EMG electrode impedance monitoring.

dissection instruments or electrodes may result in compromised NIM® operation, such as, but not limited to decreased accuracy.

anyone other than qualied service personnel may signicantly compromise the unit’s ability to monitor nerve activity and/or void the equipment warranty.

W15. e NIM® does not prevent the surgical severing of nerves. If

monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.

W16. If paralyzing anesthetic agents have been used, patient must regain

muscle activity prior to use of the NIM‑Neuro®/Response® 3.0 EMG Monitor.

W17. To avoid the risk of infection while using the NIM® Stylus, the

user must maintain good sterility practices.

W18. False negative responses (failure to locate nerve) may result from:

a. Shorted EMG electrode or cabling (conductive parts of applied

needle electrodes or cables contacting each other).

b. Patient Interface fuse blown (32mA, 250V. Xomed Part No.:

8250615). c. Patient Interface defective. d. Inadequate stimulus current. e. Inadequate current for stimulation of nerve through hardware,

such as stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve.

f. Inadvertent simultaneous current delivery from both

Stimulator (Patient Interface) probe outputs. is may result in current shunting, division between the stimulator probes.

g. Shorted internal amplier (characterized by baseline activity

of < 3μV p‑p).

W19. Stimulator current may cause involuntary patient movement

resulting in patient injury.

W20. Anesthetic agents used may have an eect on the EMG amplitude. W21. Be careful not to damage vascular structures when preparing the

nerve for the installation of the APS™ Electrode.

W22. EMG amplitude may be aected by anesthesia regimen used.

Consult anesthesiologist if EMG changes are observed.

W23. Electrode integrity should be checked aer electrode insertion

and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.

W24. Remove APS™electrode from patient prior to using external

debrillator to prevent thermal injury to patient at APS™electrode site.

W25. Avoid trans‑thoracic stimulation; when possible, maintain anode

and cathode stimulating sites in close proximity.

W26. Operation in close proximity to a shortwave or microwave therapy

equipment may produce instability in the electrical stimulator output.

W27. Safe stimulus levels are dependent on various conditions including

but not limited to: type of excitable tissue, Charge Per Pulse, and Charge Per Unit Area. Waveform morphology, repetition rate, and stimulator eective surface area must be considered. Special operator attention is required for stimulus levels which exceed default settings or conditions resulting in levels higher than 2mA RMS/cm2.

Precautions

P1. Medical Electrical Equipment needs special precautions regarding

EMC and needs to be installed and put into service according to the EMC information provided in this Guide.

P2. Portable and mobile RF communications equipment can aect

Medical Electrical Equipment.

P3. Use of accessories and cables other than those specied and sold

by Medtronic may result in increased emissions and decreased immunity of this unit.

P4. e NIM‑Neuro®/Response® 3.0 should not be used adjacent to

or stacked with other equipment. If adjacent or stacked use is necessary, the NIM‑Neuro®/Response® 3.0 should be observed to verify normal operation in the conguration in which it will be used.

P5. Loud extraneous monitoring noise is caused by activation of

electrosurgical unit. Muting Detector must be properly attached to the active electrosurgical lead.

Nerve Integrity Monitor

P6. Inability to deliver stimulus current ow may be caused by

0123

inadvertent simultaneous current delivery from both STIM1 probe outputs. is may result in current shunting, division between the stimulator probes.

P7. Avoid accidental contact between ‘PATIENT APPLIED PARTS’

and other conductive parts including those connected to protective earth.

P8. e NEW Muting Probe (Ref ‑ 8220325) is compatible with

previous versions of the NIM. However, previous versions of the Muting Probe are NOT compatible with the NIM® 3.0 System.

ROHS ‑ Environmental Friendly Use Period ‑ China (SJ/ T11364‑2006).

Conforms To IEC/EN60601‑1 Certied To CSA C22.2 No.601.1

Protective Earth

Equipotential

Symbols

LOT

ACC

Serial Number Do not dispose of this product in the unsorted municipal

waste stream. Dispose of this product according to local regulations. See http://recycling.Medtronic.Com for instructions on proper disposal of this product.

Do Not Use If Package Is Open Or Damaged.

Package Contents

Use By Date

Precaution If the single use symbol is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Lot Number Fuse Accessory

IPX1

IPX7

IPX8

Consult Instructions For Use

Caution

Protected Against Vertical Water Drops. Protected Against e Eects Of Temporary Immersion

In Water.

Rated For Water Ingress (IEC 60529)

Type BF Applied Part

Manual Start/Stop

Rf Transmitter (Interference May Occur).

Snapshot Option ‑ Open Comments and Event Title Dialog Box.

Snapshot Option ‑ Send Snapshot or Report to Printer. and Indicates a Printer is connected.

Snapshot Option ‑ Send Snapshot or Report to USB Storage Device and Indicates a USB Storage Device is connected.

REF

STERILE R

STERILE

STERILE EO

EC REP

Rx Only

Catalog Number

AC Power

Output

Is Approximately Equal To

Sterilized By Radiation. Do Not Use If Package Is Open Or Damaged.

Non‑Sterile Sterilized By Ethylene Oxide. Do Not Use If Package Is

Open Or Damaged. Authorized Representative In e European Community.

is Device Complies With Medical Device Directive 93/42/EEC

Caution: Federal Law (U.S.A.) Restricts is Device To Sale By Or On e Order Of A Physician.

Quantity

Manufacturer

Date Of Manufacture

Nerve Integrity Monitor

Buttons and Indicators

In this section all buttons used on the “Touch Screen User Interface” are displayed with an explanation of how they work.

Radio Button / Deselected: For option selection where choice is limited to one of two or more options.

Radio Button / Selected

Check Box: Deselected For option selection where choice is to enable or disable a single or multiple options.

Check Box: Selected

EMG Audio and Event Tones Check Boxes: One or both must be selected. Both cannot be deselected.

Red X: Indicates a failed test.

Green Check: Indicates a successfully passed test.

Orange Check: Indicates an Active Channel.

Select Button: Option Button See associated text indicating option.

Help Button: Opens Help Screen for Electrode Placement & Sound Samples

Increase Button: Increases value/ Setting

Decrease Button: Decreases value/Setting

Monitor Button: Opens Monitoring Screen

Measure Button: To view details of the event waveform.

Advanced Settings Button Opens: Audio, Monitoring, Stimulation, Microscope, and APS™ Panels.

Display Button: Opens panel for adjusting amplitude and time scales.

Save Button: Sends selected information to USB mass storage device.

Print Button: Used in Reports Section to print reports

Freeze Button: Freezes entire screen (all channels)

Ω

Snapshot Button: Saves current screen to memory or to selected peripheral device.

Activate Button: Activates STIM2 stimulus adjustment buttons.

Baseline Button: Initiates an APS™ baseline acquisition sequence

Electrode Check Button: Opens Electrode Status Panel

Delete/Close Button: Closes “Delete Procedure” dialog box Opens “Delete a Custom Procedure” dialog box Global Settings Button: Global Settings allows the user to select screen language, date/ time format and the Diagnostic Mode, as well as set system date/time and Restore Factory Defaults Information Button: Opens Information Screen to enter:

• Surgeon’s Name

• Patient’s Name

• Notes

Fast Rate Button: Selects APS™ Pulse Fast Rate

Normal Rate Button: Selects APS™ Pulse Normal Rate

Next Button: Opens the next screen or graphic display

Previous Button ‑ Opens the previous screen or graphic display

Yes Button: Accept/Keep

No Button: Do not Accept/Keep

Accept Button: Function as indicated.

Repeat Button: Function as indicated.

Cancel Button: Function as indicated.

Show Details Button: Used to show impedance readings

Hide Details Button: Used to hide impedance readings

OK Button: Used to close panels

Select All Button‑ Used to select all events in memory

Deselect All Button: Used to deselect all events in memory

Scroll Up/Down Buttons: Used to scroll through selected events

Restore Button: Used to restore factory defaults.

Mute Button: Used to mute channel.

Unmute Button: Used to unmute channel.

APS™ Visual Alarm Indicator and Mute Button Automatic On/O Indicator Button. Only displayed when an APS™ alarm limit has been reached and APS™ alarm tone sounds. Also used to mute APS™ alarm.

APS™ Alarm Button ‑ Used to un‑mute APS™ alarm

Channels Button: Opens a drop‑down menu used to name channels.

Channel Buttons Channels can be turned On, O or Muted

Decrease/Increase Buttons and Setting Display Used to make adjustments to the subject as dened in the open panel.

Setup

Multi State Buttons (Set‑Up used as an example): Gray = Inactive (not selectable) Blue = Selectable Orange = Selected

Set‑Up Button: Opens/Starts the setup process

Monitor Button: Opens the Main/Monitoring Screen

Reports Button: Opens the Reports Screen

Program Loading Indicator

Nerve Integrity Monitor

When the System Arrives

Unpacking and Inspection

Check o the contents of the box against packing slip. If incomplete or damaged, notify Customer Care. If container is damaged, or cushioning material shows stress, notify carrier and Customer Care. Keep shipping materials for carrier inspection. Aer unpacking, save the cartons and packing material. If the instrument is to be shipped the shipping package will provide proper protection.

Software

Soware information (manufacturer, version, and release date) is contained on a card packaged with the system. Save this card for future reference.

System Description

Device Description

e NIM‑Neuro® 3.0 is an eight‑channel the NIM‑Response® 3.0 is a four‑channel EMG monitor for intraoperative use during surgeries in which a nerve is at risk due to unintentional manipulation. e NIM®

3.0 System records electromyographic (EMG) activity from muscles innervated by the aected nerve. e monitor will assist early nerve identication by providing the surgeon with a tool to help locate and identify the particular nerve at risk within the surgical eld. It will continuously monitor EMG activity from the muscles innervated by the nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated. e monitor utilizes touch screen and color graphic user interface (GUI) along with the audio feedback to increase the usability of the device.

Indications for Use

e NIM® 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor‑sensory nerves during surgery, including spinal cord and spinal nerve roots. e APS™electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems. Indications for NIM® 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, oracic Surgeries, and Upper and Lower Extremities Indications for Spinal procedures which may use NIM® 3.0 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and oracic Surgical Procedures.

Components

Console Front

A. STIM1 stimulus adjustment. B. STIM2 stimulus adjustment. C. Volume adjustment. D. e Speaker provides audio alarms, acoustic EMG monitoring, and

voice prompts. E. Product name. F. Touchscreen – e Touch Screen displays EMG waveforms and

controls many of the functions of the NIM® 3.0.

Console Left Side

Contraindications

e NIM® 3.0 is contraindicated for use with paralyzing anesthetic agents that will signicantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

Customer Care

Medtronic Xomed, Inc.

6743 Southpoint Drive North Jacksonville, FL 32216 USA manuals.medtronic.com

Help Line

(800)‑874‑5797

International Service

International customers should contact their local Medtronic Xomed oce.

Nerve Integrity Monitor

A. USB Out: e USB Out is an industry standard USB type connector

that can be used with mass storage devices. B. Anti‑Glare Stand: is device is used to change the viewing angle of

the NIM® 3.0 screen. It is shown in the tilted (up) position.

Console Rear

Accessory Power Outlet: e Accessory Power Outlet used with

the approved NIM® 3.0 Accessories (i.e. the approved printer power supply only).

B. Fuse Access: e AC power fuses are located on the back of the

units. C. Power Switch: e power switch turns the power ON or OFF. D. Power Connector: e power cord plugs into the back of the NIM®

3.0 System console. e input fuses and accessory output is in the

power entry module. Plug the power cord into the A/C power outlet. E. Equipotential: Uniform potential. F. For future use. G. USB Out: e USB Out is an industry standard USB type connector

(two port) that can be used with mass storage devices/printer/

keyboard. H. VGA Output: Used only to connect NIM‑Neuro® 3.0 System to

microscope. Not active on NIM‑Response® 3.0 System. I. Surgeon Mini Screen Port: Output connection to Surgeon Mini

Screen or video recorder. J. Muting Detector Input: Near‑eld radio frequency detector. K. Patient Interface Connector: e patient interface connector is a

25‑pin D‑sub. L. Handswitch APS™only. M. RCA Audio Jack: An RCA audio jack is provided to output an audio

signal that can be overlaid onto a video signal when using industry

standard recording devices. e output will be audio line level (1 Vp‑

p). N. Mini Jack: Standard conguration is for private listening through

Stereo Headphones. O. Carry Handle for transporting unit. P. Anti‑Glare Stand: is device is used to change the viewing angle of

the NIM® 3.0 screen, it is shown in the tilted up position.

Important:

Intraoperative use of the VGA Out, and RCA Phone Jack requires special considerations to remain compliant with IEC/EN60601‑1. Contact Medtronic Xomed for recommendations if intraoperative use of the VGA Out, RCA Phone Jack.

Patient Interface

D. Stimulus (out) Jack E. Stimulus Return F. Electrode ground: signal return for patient electrodes. G. Patient Interface Clips. H. Negative Electrode Jacks: Negative electrodes have black wires and

color‑coded plugs.

I. Positive Electrode Jacks ‑ Positive electrodes have matching color‑

coded wires and plugs.

J. e Patient Interface fuses are for Stimulator Output and are

specically tested for ECU protection. Use Xomed 11270048 Fuse, 5 x20mm, 32mA, 250 V. Order 8253075 Fuse Kit for replacements.

K. NIM‑Response® 3.0 Patient Interface shown for reference only.

Patient Simulator

e Patient Simulator is used for troubleshooting and demonstrating the system without the need for patient interaction.

A. Stimulator pads (Simulated Events). B. Stimulator return (anode) plug. C. Electrode ground plug D. Simulated subdermal electrode plugs.

Stimulator Probes/Handles

e Stimulator Probes and Handles carry stimulus current from the console, via the Patient Interface, to the patient.

Monopolar

Ball Tip Probe

A. Stimulus to Patient Contact Area B. Insulated Sleeve C. Probe Base

Standard Prass Flush Tip Probe

A. Stimulus to Patient Contact Area B. Insulated Sleeve C. Probe Base

Incrementing Monopolar Probe Handle

e Incrementing Probe provides the ability to adjust the stimulus, and to print or save events from within the surgical site.

A. Patient Interface to console connector

Aa. Connector release. B. Stimulating Instrument Jack or Stimulator Probes (Monopolar or

Bipolar). C. Incrementing Probe Control Jack: Connects Incrementing Probe

controls to the NIM® 3.0.

A. Probe Jack B. Toggle Button C. Stimulus Plug D. Toggle Button Control Plug

Incrementing Probe Stimulus Adjustment

e (single use) Incrementing Probe provides the surgeon with the means to adjust the stimulation current at the surgical site.

Nerve Integrity Monitor

Note: If the incrementing probe handle malfunctions, immediately disconnect the Toggle Button Control Plug from the Incrementing Probe Control jack from the Patient Inter face and use console touch screen buttons to adjust stimulus cur rent.

B1 Toggle button normal or at rest. B2 Increase current. B3 Decrease current. B4 Press and hold saves current screen to memory (for Reports) and to selected peripheral device (Printer and/or USB ash drive).

Universal Monopolar Probe Handle

APS™ Electrode Handswitch

APS™ Electrode Handswitch – e handswitch cycles through the APS™ functions (O, On, Slow, Fast).

A. umb Switch B. Cable

Electrodes

Electrode types recommended for use with the NIM® 3.0 System

EMG Endotracheal Tube: Contact electrodes designed to monitor both vocal cords.

Hookwire Electrode: Two small wires attached to the end of a hypodermic needle. Injected intramuscularly (then the hypodermic needle is removed) e wires are insulated to within 3 mm of the end and are designed to obtain a more specic response.

A. Probe Jack. B. Handle. C. Stimulus Plug.

Bipolar

Side-by-Side Stimulating Probe

A. Stimulus to Patient Contact Area. B. Insulating Sleeve. C. Stainless Steel Tubing. D. Cable Connection.

Prass Flush Tip Stimulating Probe

A. Stimulus to Patient Contact Area. B. Insulating Sleeve. C. Stainless Steel Tubing. D. Cable Connection.

Muting Detector

See Precaution P8. e Muting Detector Probe is designed to detect the presence of electronic noise from external devices (such as electrocautery/ electrosurgical unit) that may cause interference on the EMG monitor.

Paired Subdermal Electrodes: Non‑insulated high performance electrodes with 2.5mm spacing.

Prass Paired Electrodes: e electrodes are insulated to within 5mm of the end with 5mm spacing. Muscle‑specic single use.

Prass Paired Electrodes Small Hub: e electrodes are insulated to within 5mm of the end with 2.5mm spacing. Muscle‑specic single use.

Subdermal Needle Electrodes: Non‑insulated high performance electrodes 12mm long with a 0.4mm diameter.

Electrode Ground (Green with Green Wire) and Electrode Stimulus Return (Red with White Wire): Always locate these electrodes in a non‑innervated, electrically neutral area (electrically neutral areas are where the bone is close to the skin and the electrode will not contact muscle tissue). Ground should also be located between the stimulator and monitoring electrodes.

Stimulating Electrodes 2 mm and 3 mm.

Anti‑slide Ring. B. Insulating Sleeve. C. Ferrite. D. Cable Connector. E. Electronic Noise Detection Area.

Nerve Integrity Monitor

Power Cords

1897821 Power Cord, 6 Meter, 115V 1895820 Power Cord Standard 1895822 Power Cord, Europe 1895823 Power Cord, Japan, 100V

The Splash Screen

Self Test

An internal integrity check is automatically performed each time the system is turned ON. (See Warning W8) On Power‑up a series of messages are briey displayed. en the console does a series of self‑tests on the hardware.

Set-Up Mode

Select Procedure Step 1 of 2

Information

Reports

NIM- Respon se® 3. 0

1. Select Procedure

Setup

Step 1 of 2

Neuro/Otology

Head/Neck

Peripheral

Custom Procedures

Monitoring

Global Settings

Information

H G

321

654

987

Reports

S et D a t e

a nd T i m e

D ia g n o s t i c M o d e

E na b l e D B S a v i n g

R es t o r e

D ef a u l t s

NIM -Resp onse® 3.

Global

Help

Global

Help

Settings

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Monitoring

G lo ba l Se tt i ng s

1 /2 7 / 2 0 0 7 1 1 : 3 4 : 06 P M

1 /2 7 / 2 0 0 7 2 3 : 3 4 : 0 6

2 7/ 1 / 2 0 0 7 2 3 : 3 4 : 0 6

2 00 7 / 1 / 2 7 2 3 : 3 4 : 0 6

Mo n i t or i n g P r of e s s io n a l

<title>

N ot e s

5/1/2009 9:00 AM

1. Select Procedure

L an gu a ge

E ng l i s h

Neuro/Otology

F re n c h

I ta l i a n

G er m a n

S pa n i s h

Custom Procedures

D at a F ie l ds fo r C a se No t es

S ur g e o n

P at i e n t N am e

P at i e n t I D

P at i e n t D OB

* indicates default settings have been changed

Setup

Step 1 of 2

D at e/ T im e F o rm a t

Head/Neck

Peripheral

is panel is accessed by pressing the Global Settings button in any of the Set‑Up Mode Screens. A. Global Settings Panel. B. Language panel: Select language. C. Data Fields: Select the elds to be populated in the Case Information

Screen.

D. Blank data elds: Allows the operator to name two elds that will

appear in the Case Information Screen. E. OK button will close Global Settings. F. See Buttons and Indicators. G. Enable DB Saving check box (o by default), this will turn on the .db

option in Reports Mode. H. Diagnostics Mode: Not for end users. Should be used only under the

direct supervision of Medtronic Xomed personnel. I. Opens a data entry key pad for setting the date and time.

Date Format: 03/18/2008

Time Format: 09:24:34 AM

Set Date/Time

03/18/2008

Date:

03/18/2008

Date:

09:24:34 AM

Time:

09:24:34 AM

Time:

AMAMPM

Clear

Global

Settings

Help

* indicates default settings have been changed

5/1/2009 9:00 AM

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

is is the default screen, requiring the operator to select an existing procedure or begin a new (custom) procedure. Optional: Operator may enter/change Date, Time, Language, or Data Fields via Global Setting button. A. Tool Bar: Used to select any of the major (3) functional Modes. B. Set‑Up Button: Selected by default. C. Monitoring and Report Button‑ not selectable at this operation. D. Help Button: See Help screen. E. Global Settings Button: See Global Settings screen. F. Time and Date Bar: is bar shows the time and date as set in the

Global Settings panel. In addition it displays the GUI and DSP version.

G. Print and Save Icon: ese icons are displayed automatically (in

all screens with a time and date bars) only if a USB drive and/or a

Printer are connected. H. Select Procedure: Drop down menus. I. Set‑Up Wizard Navigation Bar. J. Information Button: See Case Information.

• Date entry elds for date and time.

• AM and PM radio buttons.

J. Date/Time Format: Used to select how date / time is displayed. e

default format is sensitive to language.

Help

Electrode Placement

Diagram

Nerve

Procedure

VII (2ch)

Setup

Audio Samples

Monitoring

Setup

5/1/2009 9:00 AM

is screen will display help graphics for locating electrodes or sample audio sounds. A. Electrode Placement: is tab selects help graphics for locating

electrodes.

B. Audio Sample: is tab enables sample three sound buttons:

• Pulse

• Train

Reports

MIN-Response® 3.0

Global

Settings

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Help

Nerve Integrity Monitor

• Burst

C. Diagram/Nerve: Radio button selects help graphics by nerve

number/name. D. Diagram/Procedure: Radio button selects help graphics by

Procedure. See Place Electrodes Step 2 for example. E. Previous Next Buttons: For changing graphics. F. Graphics display area. G. OK button will close Help screen.

Place Electrodes Step 2 of 2

Opens automatically aer selecting a factory installed procedure.

Mastoid

2. Place Electrodes

Setup

Step 2 of 2

Monitoring

Monitor

Information

11/4/2008 10:00AM

Reports

Electrode Check

Warning: EMG Monitoring

Is Disabled

Please Wait

1 - Orbicularis Oculi

2 - Orbicularis Oris

Stim 1 Return

Ground

Ω

Show Details

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Electrode Check

Procedure Settings

is screen will assist the operator with electrode location. It also runs an electrode check, this screen shows that electrodes are being tested.

Note: If changes to the procedure are to be made and saved, then those changes must be made before selecting the Monitor or Monitoring button. Note:

• is screen can be bypassed by selecting the Monitor or Monitoring button.

• If bypassed there will be no pre-surgery impedance values of the electrodes, ground, or STIM1/2 available to printed/saved reports.

• If the patient interface, electrodes, ground, STIM1/2 were disconnected when this screen was opened, any printed report will show a failure of the impedance values of the disconnected item(s).

A. Tool Bar: Used to select any of the major (3) functional Modes. B. Set‑Up Wizard Navigation Bar.

• Previous: Returns to the Select Procedure screen.

• Monitor: Opens the Monitoring screen. See Monitoring Mode for details.

Note: If changes were made in the Electrode Check panel , the Procedure S ettings panel,or one of the Procedure Settings/ Advanced Settings Tabs a dialog box will open asking if the operator wishes to save said changes.

• Information: Opens the Case Information screen. See Case Information for details.

C. Electrode Check Tab: Closes/Opens Electrode Check panel. See

Electrode Check Panels for details.

D. Procedure Settings Tab: Opens/Closes Procedure Settings Panel. See

Procedure Settings Panel for details.

E. Electrode Placement Graphic: Shows electrode placement for both

the patient and patient interface.

Mastoid

2. Place Electrodes

Setup

Step 2 of 2

Monitoring

Monitor

Information

Monitor

Information

11/4/2008 10:00AM

Reports

Electrode Check

Warning: EMG Monitoring

Is Disabled

Please Wait

1 - Orbicularis Oculi

2 - Orbicularis Oris

Stim 1 Return

Ground

Ω

Show Details

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

Electrode Check

Procedure Settings

is screen shows that a two (2) channel surgery (Mastoid) was selected. Channel 1 will be used to monitor Orbicularis Oculi and channel 2 Orbicularis Oris. B. Closes Electrode Check panel. C. Monitoring is disabled when the Electrode Check panel is open D. Electrode status eld:

• Progress bar: Displayed while electrodes are being tested.

• Question Marks: Question marks are visible while the electrode test is running and will be replaced with pass (green check mark) or fail (red x) mark.

E. STIM1, STIM2, and Ground status elds.

Note:

• ere is no STIM status (blank) if Bipolar is selected in the Type Panel (located in the Advanced Settings/Stimulation Panel).

• ere is no STIM2 status (blank) if a single stimulator is connected.

• STIM2 will be displayed aer it is turned on using the Activate button located on the main screen or selecting the STIM2 or APS™ check box on the Procedure Settings/Stimulation Panel.

• STIM 1, STIM 2, Ground - A question mark aer the test has completed means that no channel electrode or ground was connected therefore no value (impedance) was read. At least one channel electrode and ground must be connected for the system to read STIM 1, STIM 2, and Ground impedance.

F. Show Details button: See Electrode Check/Show Details. G. Print Button: Sends the electrode, ground, and STIM1 & 2

impedance values to the Printer.

Note: Print button is displayed only if a printer is connected.

Electrode Check Panel Pass/Fail

e impedance values of the electrodes to the patient are measured to conrm the integrity of the connection.

Electrode Check

Warning: EMG Monitoring

is Disabled

1 - Orbicularis Oculi

2 - Orbicularis Oris

Electrode Check

Electrode Check, checks the integrity of the patient to Patient Interface connections. It is also the only location where electrode type in use can be changed.

Electrode Check Panel

is panel can be accessed from two (2) locations: A. Electrode Check Panel is typically displayed in the Set‑Up Mode

with Place Electrodes Screen. It may be opened or closed at this screen using the Electrode Check Tab.

Note: Changes made in the Set-Up Mode can be saved. The only saveable change (saveable to a new or existing procedure) that can be made at this panel is the electrode type being u sed. If printing a report it will include electrode values, it will not include electrode type .

Nerve Integrity Monitor

Stim 1 Return

Ground

Ω

Show Details

is screen shows that channel 1, stimulus return, and ground electrodes have passed where channel 2 has failed.

Electrode Check Show Details Panel

Press the Show Details Button to see the actual impedance values. See the Electrode Troubleshooting Guide in this section.

Electrode Check

Warning: EMG Monitoring

is Disabled

Subdermal

(+) 5.9kΩ (-) 5.9kΩ

(+) 6.0kΩ

(-) 55.8kΩ

1 - Orbicularis Oculi

2 - Orbicularis Oris

∆ 0.0kΩ

∆ 48.2kΩ

Electrode Check

Case Information

Opens aer pressing Information Button.

Mastoid

Enter Case Information

Surgeon

Patient ID

Patient Name

Setup

Monitoring

Monitor

Reports

8.1kΩ

6.6kΩ

Electrode Type Button.

Stim 1 Return

Ground

Hide Details

Electrode Type Panel

Electrode Check

Warning: EMG Monitoring

is Disabled

Subdermal

1.5kΩ

0.7kΩ

Hide Details

(+) 5.9kΩ (-) 5.9kΩ

(+) 6.0kΩ

(-) 55.8kΩ

Sub derm al

End otra che al Tu be

Hoo kwir e

Pra ss P air ed

Sur face

1 - Orbicularis Oculi

2 - Orbicularis Oris

2 - Orbicularis Oris Electrode Type

Stim 1 Return

Ground

∆ 0.0kΩ

∆ 48.2kΩ

8.1kΩ

6.6kΩ

Electrode Check

At this screen Radio Buttons are used to select the type of electrode being used (Subdermal by default).

Electrode Troubleshooting Guide

Symptom Cause Solution

Electrode impedance is too high. > 10KΩ for subdermal electrodes > 10KΩ for EMG tube Electrode impedance ≤0.1KΩ

Electrode reading is (+ or ‑) O or Δ = = = =

Question mark at STIM 1/2, and Ground in Electrode Check Panel

• Electrode dislodged from patient, but not completely out.

• High resistance in electrode.

• Electrode pin not rmly inserted into patient interface.

• Positive and negative electrodes touching below surface of skin.

• Extremely low impedance, particularly in EMG tubes.

• Electrode laying on skin surface.

• Electrode placement insecure.

• Dirty electrode tip.

• Electrode cable is broken.

• Electrode pin disconnected from patient interface.

• No channel electrode connected.

• Ground not connected.

• Insert dislodged electrode; tape down in place.

• Remove and replace with new electrode.

• Check connection at Patient Interface box.

• Remove and relocate electrodes.

• Re‑insert electrode in question.

• Remove and replace electrode in question.

• Check connection to Patient Interface box.

• Connect at least one channel electrode.

• Connect ground.

MIN-Response® 3.0

Notes

MIN-Response® 3.0

Procedure Settings

Global

Help

Global

Help

Settings

7/1/2008 9:00 AM

GUI vxxxx.x.xxxxx DSP vxxx.x.xx.xxxx

is screen is for data entry into preselected data elds. See Global Settings for data eld selection. A. Tool Bar: Used to select any of the major (3) functional Modes. B. Set‑Up Wizard Navigation Bar: Previous, Monitor see Buttons and

Indicators.

C. Case Information: By pressing any of the information elds a

keyboard for data entry will open. D. Procedure Settings Tab: Opens Procedure Settings panel. E. Global Settings, and Help Buttons: See Global Settings.

Procedure Settings Panel

is panel can only be accessed in the Set‑Up Mode Place Electrodes screen.

Note: Changes made in this panel can be saved (saveable to a new or existing procedure). If printing a snapshot it w ill include changes to:

• Channels

• STIM1

• Event reshold

• Procedure name (if changed)

If printing a report it will also include changes to STIM2:

Stimulation

Event Thershold

Save

Channels

1: Orbicularis Oculi

2: Orbicularis Oris

3: Inactive

4: Inactive

5: Inactive

6: Inactive

7: Inactive

8: Inactive

Stim1

30.0

Stim2

100

µV

APS

Advanced

Settings

Procedure Settings

e user can review and/or change the monitoring settings for the procedure. A. Channels: used to add, remove, or change the names of the channels

1. Press the Channel button, drop down list of channels will open.

2. Press an active channel to inactivate that channel. Press an inactive

channel to open the Muscle Name keyboard.

Nerve Integrity Monitor

3. Muscle Name: a. Use the Scroll buttons to locate an existing muscle group. b. Highlight (touch the screen) the muscle name. c. Press OK to enter name and exit.

Or a. Key in (type) new muscle name. b. Press OK to enter name and exit.

B. Stimulation Panel: Used to adjust STIM1 stimulus and STIM2 or

APS™stimulus (if selected).

Example shows panel with STIM2 selected.

C. Event reshold Panel: Adjust the event threshold, the range is from

20μV to 2500μV in increments of 5μV.

D. Save Button:

a. Opens save option panel. b. Save option panel gives the operator the option to overwrite the

existing procedure, create a new procedure or cancel. E. Advanced Settings Button: See “Advanced Settings” for details. F. Closes the panel.

Advanced Settings

Advanced Settings function:

• Advanced Settings adjustments made in the Set‑Up Mode (Procedure Settings Panel), can be used for the current session OR saved.

• Advanced Settings adjustments made in the Monitoring Mode (Control Panel) are eective only for the current session and CANNOT be saved.

When the Advanced Settings button is pressed, a screen is opened with tabs that allow access to the functions described.

Audio Tab

Please review “Audio – Understanding What You Hear” with this section.

Audio Settings: congures system to determine what sounds will be heard during monitoring and balance between various sounds.

Note: If APS™ is active, the Event Tones volume balance will control the APS™ volume balance.

Nerve Integrity Monitor

B. Stimulus Delivery Audio: e default setting is Brief Tone.

Additional options:

• Brief Tone (default): Delivery of stimulus current is accompanied by a brief warbled tone.

• Continuous Tone: Delivery of stimulus current is accompanied by a continuous, warbled, high‑low tone (referred to as “Stimulus Warble Tone”).

• Voice ‑ Stimulus: Delivery of current to the surgical eld is announced by the word, “STIMULUS”.

• Voice ‑ Setting: Delivery of current to the surgical eld is announced by the value of the stimulus setting.

Note: Stimulus Delive ry Audio is not heard when an event has occurred.

C. Monitoring Audio: ere are two options, EMG Audio and Event

Tones. At least one selection must always be active however, both options may be selected.

• EMG audio: is the amplied sound of muscle activity that is heard instantaneously as the nerve is stimulated. All EMG activity, regardless of amplitude, is audible when the EMG audio is ON. e EMG activity may sound like a low‑pitched “drumbeat”, a high‑pitched “crackle,” or a “growl”. When multiple channels are monitored, it is unlikely that you will be able to dierentiate the EMG signals as to their channel of origin strictly by the sounds they produce.

• Event Tones: are heard when the EMG amplitude is larger than the Event reshold setting. e Event Tones are easily heard over O. R. noise and are heard at the same time with the EMG audio, previously mentioned.

User can dierentiate channels by tones pitch. e tone for channel 1 activity is lower in pitch than the channel 2 and so on for channels 3 through 8. When EMG activity exceeding the event threshold occurs at the same time on multiple channels, only two of the tones sound at once. User may allow individual EMG channels to be muted by selecting Show Channel Mute Buttons.

D. Volume Balance: Sound levels can be adjusted using the + and –

buttons for EMG Audio, Event Tones and Voices. A numeric value and white bar graph will indicate the setting relative to full scale (scale is 1 to 5).

E. OK button will close Advance Settings panel.

Monitoring Tab

A. View Scale, see Control Panel Display Button. B. Measurement Cursor Position, selects the measurement start

position:

• Peak Amplitude ‑ selects the largest peak to peak value

• Latency ‑ will place the cursor where the response to a “Stimulation” begins. See also Control Panel Measurement Button.

C. Event Capture/Auto reshold Check Box:

If Event Tones are continuous for 10 seconds:

• Auto reshold will automatically calculate a new Event reshold (to a maximum of 400μV).

• All activity less than the new Event reshold will be heard as raw EMG.

• EMG activity greater than the new Event reshold or greater than 400μV will generate Event Tones.

• Additionally, if the Voice setting is selected, it will announce the amount of threshold increase.

• e Event reshold will return to the original value aer 10 – 20 seconds of no, or decreased, event activity.

D. Event Capture/Sequence Display/Last (default setting)

• If Last and Event Capture (see Control Panel) are selected, the most recent event will be displayed until replaced with a new or more recent event.

• If Largest Overall and Event Capture (see Control Panel) are selected, and multiple events occur over a period of 4 seconds then the largest event from the series of events will be displayed as Largest x of x (example 3 of 5).

• is will remain displayed until replaced with the next event or next largest event from a 4 second series of events.

Note: that neither Event Capture nor Largest are available when the x-axis time s cale is set to 1 0 seconds (it is only available in the 50ms time scale).

E. Stimulus/Rejection Period, is an adjustable delay allowing the small

amount of electronic noise caused by stimulation (Stimulus Artifact) to stabilize before reading EMG data.

Stimulus Artifact Example a. Original Rejection Period setting. b. Stimulus Artifact. c. Move Rejection Period line to here to avoid artifact. d. EMG Response.

Note: In previous versions of the N IM, Stimulus Rejection Period was referred to as Stimulus Artifac t or Artifact Delay.

Special Note on Recognizing Artifact

e NIM® 3.0 System features sophisticated artifact rejection technology designed to provide highly sensitive and accurate monitoring. However, there may be electrically generated signals in the range of true response that the NIM® 3.0 System cannot dierentiate.

Examples:

• A transcutaneous stimulator used by the anesthesiologist might

generate an audible signal.

• Any external nerve locator/stimulator not synchronized (Muting

Detector) with the NIM® 3.0 System.

• Electrical leakage from faulty thermal cautery units. You can

identify the spurious signals by their lack of surgical context (there was nothing the surgeon was doing at that moment that could have caused a true EMG response).

• If the recording electrodes and the stimulator (+) or (‑) cables

become tangled the resulting stimulus artifact might be spuriously detected as an EMG event. Be careful to route the recording electrodes away from stimulator cables.

• e pace pulse generated by pacemakers may be detected and

displayed by the NIM® 3.0 System as a rhythmic artifact signal. is is caused by the electrode ground or stimulus return electrodes being in close proximity to the pacemaker or its lead wire(s). e artifact caused by the pacemaker may be reduced by repositioning the Electrode Ground and Stimulus Return electrodes to the top of the patient’s shoulder (the Acromion) (use shoulder opposite operated side). e Electrode Ground (green plug green wire) and Stimulus Return (red plug white wire) electrodes should be positioned about 5 cm apart, green Proximal, red Distal. Once the electrodes are repositioned, verify that the Stimulus Return and Impedances Ground are within tolerance (review Panels / Electrode Check ).

• ere may also be interference‑generated signals in the range

of true response that the NIM® 3.0 System cannot dierentiate. An example of this type of artifact signal could occur when the surgeon strikes two metal instruments together within the surgical eld, such as a metal suction tube with a dissecting tool. Such signals are typically monophasic with fast onset and oset. at is, the signals appear on the screen as sharply peaked responses in one direction only.

• While these artifacts are signicantly dierent in waveform appearance from true EMG events (which have a biphasic waveform), the magnitudes of these signals can reach several hundred microvolts causing the event tone to sound. However, the surgeon is usually aware when two instruments have been struck together and can, therefore, relate such “false positive” responses to the surgical context.

F. Waveform Filters

• Artifact Filter: Selecting this Check Box enables the detection of artifact as “Spiked Waveforms” (see Mechanical Stimulation in Appendix C)

• Low Frequency Filter: Low Frequency Response is generally caused by the movement of the electrodes, electrode wires, tissue etc. is can result in a response that is not a true EMG response. Selecting this Check Box enables a lter that reduces Peak to Peak amplitude (about 20%) in a frequency range below 70Hz reducing unwanted response. e lter is on by default for all procedures.

G. OK button will close Advanced Settings panel.

Stimulation Tab

Important Note on Stimulator Adjustments

e absolute stimulus intensity required to adequately stimulate any motor nerve is determined by a complex combination of several factors including (but not limited to) the following:

• e functional health of the nerve itself.

• e type of stimulation probe used (monopolar or bipolar).

• Proximity to the nerve.

• e pulse width of the stimulus.

You should use the smallest amount of stimulus necessary to elicit a detectable EMG event. Stimulus current levels of 0.3mA may be high enough for adequate direct monopolar stimulation of the facial nerves, but may elicit little or no response when monitoring motor evoked potentials. e best guideline for setting the stimulus intensity level is to use the lowest amount that produces an EMG event.

The surgeon should be aware:

• at STIMULUS is continuously being applied to the STIMULATOR probe and/or the APS™).

• STIMULATING the patient is the result of physical contact between the patient and the STIMULATOR probe.

• e STIMULATOR probe should be kept ISOLATED when NOT STIMULATING the patient (except APS™).

Note: Stimulator adjustment involves the adjustment of the Cur rent, Rate , Pulse Width, and the Stimulus/Rejection Period.

Note: To prevent inadvertent high stimulus levels, the rst time the stimulus level exceeds the Current Warning Level , a dialog box will open:

Stimulus in excess of 3 mA

Press OK to allow stimulus

If using the procedures Lower Extremity, Knee, or Ankle the stimulus level warning is set at 12.0 milliamperes.

A. Name/text eld, pressing the text eld will open the Stimulator 1 or 2

Name keyboard.

Nerve Integrity Monitor

+ 30 hidden pages

Medtronic NIM-Response 3.0, NIM-Neuro 3.0 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual