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

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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

a. Use the Scroll buttons to locate an existing probe. b. Highlight (touch the screen) the probe name. c. Press OK to enter name and exit.

Or a. Touch screen at Stimulator (1 or 2) Name. b. Key in new name. c. Press OK to enter name and exit.

B. Type Panel is used in the selection of monopolar or bipolar probes.

By default monopolar is selected. If bipolar probes are being used the operator must change probe type at this location.

C. is panel is used for making adjustments to the stimulus Rate . D. is panel is used for making adjustments to the stimulus Pulse

Width.

A Pulse Width (duration time of each pulse)

B Rate (number of pulses per second)

E. Maximum Current Setting used to adjust stimulator current if being

accessed from Set‑Up/Procedure Settings/Advanced Settings. No adjustment is available if accessed from Monitoring/Control Panel/ Advanced Settings.

F. If using an APS procedure all adjustments to STIM 2 should be done

using the APS Tab except for the Name/text eld (A) of this section. If using a monopolor or bipolor probe adjustments are the same as STIM 1.

G. OK button will close advance settings panel. Repeat for Stimulator 2 panel.

NOT E: If an APS™ procedure has been selected, then the Stimulator 2 Panel/Rate adjustment will be found on the APS™ Tab.

Microscope Tab (available on the NIM-Neuro® 3.0 only)

Note: When the “Display Overlay” check box is NOT checked all other parts of the panel are not displayed. e following graphic shows all default settings.

Note: Not all video input microscopes are compatible with the NIM® 3.0 System. Contact Customer Care at 1(800)874-5797 for specifics.

• Operator can select between displaying any event or events

Example

resulting from stimulation.

B. Operator can select where the overlay is displayed.

• Location is ne tunable at plus or minus 60 pixels using the horizontal or vertical oset adjustment.

C. Resolution should be set to the value specied by the microscope

manufacturer.

D. Select to display an event until replaced with a new event, or have the

display turn o aer a selected period of time.

E. Select to have display show data only or data and waveform. Example

shows data with waveform.

F. Select OK button will close advance settings panel.

APS™ Tab (Automatic Periodic Stimulation)

APS™Channels: Channel 1 and 2 checked by default.

B. Alarm Limits:

• Amplitude sets the alarm to sound if the EMG response tolerance limit is reached (default is 50% less than baseline and lower than 2000µV).

• Latency sets the alarm to sound if the latency tolerance limit is reached (default is latency value plus(+) 10%).

C. Stimulation: “Slow Rate” and “Fast Rate” are selected at this panel.

e operator may switch between these rates when in monitoring stimulation. Default setting is:

• Slow Rate 10/min (10 per minute)

• Fast Rate 1/S (1 per second).

NOT E: The Pulse Width adju stment for APS™ is found on the Stimulation Tab Stimulator 2 panel.

D. APS™ EMG:

• Show APS™ Waveforms selected by default, the waveforms from APS™ stimulation is shown on the “Monitoring Screen” in blue with EMG response in white.

• Mute APS™ EMG Audio: Mutes the APS™ EMG Audio (pop, pop, pop sound).

E. OK button: will close advance settings panel.

A. Display Overlay is used to activate the microscope overlay video

output.

Nerve Integrity Monitor

Monitoring Mode

C DB

is screen is displayed by selecting the Monitor or Monitoring button. It is the screen displayed during surgery and shows all EMG activity. APS™ is not shown. A. Tool Bar: Used to select any of the major functional Modes. B. Set‑Up Button: opens the Set‑Up Screen. C. Monitoring Button: Opens the Monitoring Screen. D. Report Button: Opens the Reports Screen. E. STIM1 Panel: Displays the stimulation setting (large numbers), the

measured value (in the small window), and adjustment buttons for the STIM1 current settings.

F. STIM2 Panel: If inactive it will display the “Activate” button. If active

as a second stimulator it’s display is the same as STIM1. If an APS™ procedure has been selected then the Vagus APS™STIM Panel will be displayed:

Vagus APS Stim

1.00

0.00 mA

Vagus APS Stim

1.00

1.00 mA

270 µV

5 µV

J. 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. K. Date, Time, GUI, and DSP version. L. Control Panel Tab: Opens Control Panel. M. Channel Label: Displays the channel number and nerve being

monitored. N. Trace: Displays stimulus nerve activity/inactivity. O. Scale: Displays screen scale settings. P. Artifact Delay: Shows where artifact ends and EMG begins. Q. Amplitude: Displays in microvolts activity level on each channel:

• A box will enclose the activity level of any channel showing an event.

• If there are multiple channel events, the box will enclose the largest.

• If the system detects a signal (response) that is outside the range of the systems ability to measure (80 ‑ 100,000μV or higher) “Out of Range” will be displayed.

Control Panel

347 µV

75 µV

e Control Panel, is used for additional settings and monitoring features. A. Display Button, opens the Scale Panel.

APS On

Pulse Rate

Baseline

APS On

Pulse Rate

Baseline

• e APS™ On, check box, Slow Rate, and Fast Rate buttons will be inactive (grey) until aer the APS™Baseline has been established.

• See System Set‑Up/ APS™Settings for how to establish a baseline.

G. Events Panel: is panel displays the Event reshold settings and

allows the operator to adjust the setting level (in 5μV increments).

• EVENT THRESHOLD is a highly sensitive lter used to dene where EMG activity becomes signicant.

• EMG activity exceeding this “THRESHOLD” is dened as an “EVENT” and results in Event Tones (alarms) sounding.

• Set “Event reshold” by pressing plus/minus buttons to increase or decrease the value as desired. Setting is displayed in micro‑Volts.

a. If the Event Capture is turned on (default) the Snapshot Button

will be visible.

Note: Event Threshold adjust buttons are unavailable for APS™ monitoring. See Control Panel to adjust Event Threshold.

H. Snapshot Button: Saves current screen to memory (for reports) or to

selected peripheral device:

• Comments Icon Snapshot Option ‑ See Control Panel.

• Print and Save Icon Snapshot Option ese icons are displayed automatically if a USB drive and/or a Printer are connected ‑ See Control Panel.

Note: Snapshots (print or save) show event information only and will not include the impedance values of the electrode, ground, or STIM1/2 .

I. Volume Panel: Displays adjustable volume setting.

Sound levels can be adjusted using the volume knob (see Console Front, Item C). A numeric value and white bar graph will indicate the setting relative to full scale. e default setting is 50.

347 µV

e vertical portion of the EMG display represents Amplitude and the scale is adjustable (500μV by default). e vertical screen is divided into equal sections per channel with 1/2 of each channel positive and 1/2 negative. Each channel is separated by a solid blue line.

b. Time scale is represented by the horizontal portion of the EMG

display and is adjustable (25mS by default) (see Advanced Settings / Monitoring Tab). e screen is divided into equal sections. is diers from the “Amplitude scale” in that the “Time scale” selection is the entire horizontal portion of the screen.

c. OK Button, closes Scales panel.

Note: Chang ing either scale only affects how the data appears on the screen. It does not modif y the s ensitivity of the unit.

B. Electrode Check: See Electrode Check Panel.

Nerve Integrity Monitor

C. Freeze: Pressing the “Freeze” button causes the screen contents to

be displayed, unchanged, until the next press of the Freeze button “unfreezes” the display. is is useful to view an event over an extended period.

Note: Any events that take place when Freeze is on are not displayed.

D. Measure Button: for viewing details of an event waveform.

227 µV, 5.25 mS

27 µV, 5.25 mS

e on screen display (green) will show the amplitude (μV) and

347 µV

55 µV

5.25

time (mS) at the cursor location.

• Time is measured from zero (0) not from Stimulus/Rejection

Period.

• Amplitude is measured from the channels zero (0) with a

minus (‑) sign for negative numbers and no minus sign for

positive numbers. b. e time will also be shown in the display. c. Cursor Position buttons will move the vertical (green line) cursor

le or right in increments of 0.25mS.

d. e cursors and displayed value will turn o when the measure

OK button is pressed.

E. Events/Event Capture: Captures and holds EMG activity that exceeds

the EVENT THRESHOLD.

F. Events/Snapshot Action:

• Comments: Opens comments panel allowing comments and

Event Titles (titles may be entered via keyboard or selected from a pre‑dened list) to be added to the captured event when the Snapshot button is pressed. ese comments/title will be displayed on the printed and/or saved event.

• Comments and Event Titles can be modied in Reports Mode.

• Print: Sends captured event to the printer with comments if

selected when the Snapshot button is pressed.

• Save: Sends captured event to the USB mass storage device with

comments if selected when the Snapshot button is pressed.

G. Advanced Settings button: Opens Advanced Settings. See Set‑Up

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

H. Help: Is available as abbreviated assistance on the Monitor Display.

APS™ STIM Panel: Shows default settings aer running APS™ Baseline.

B. APS™ Waveform: Appears as a Blue Trace (on all channels if “Show

APS Waveforms” is on(default) in Advanced Settings APS tab). C. EMG Waveform: Appears as a White Trace (on all channels). D. Limit Lines: e upper limit for Latency and lower limit for

Amplitude are displayed as red dotted lines. E. Baselines: For Latency and Amplitude are displayed as white dotted

lines.

Waveforms: For Latency are a series of turquoise dots and a series of

blue dots represents Amplitude. F. Latency and Amplitude are separated by a scaled line. is line is the

time base as shown at top le of screen (L). e scale marks are one

minute apart. G. Values: For the alarm (if sounded) are shown at the Limit Lines and

the measured value of the last pulse is shown at the Baselines. H. Alarm Indicator: is indicator shows that a alarm was selected

(default) on the Audio Setting Panel. Also serves as a Mute button. I. Values: EMG measured values are displayed in white with the largest

value boxed in yellow, APS™ measured values are displayed in blue.

The APS™ Monitoring Screen

APS™ is a process wherein a nerve at risk is continuously being stimulated. is stimulation is monitored and charted continuously in real time. Trends can be plotted and observed. e plotted characteristics are:

• EMG (response to stimulation)

• Latency (time from stimulation to the “Onset” of the EMG response)

e plotted chart displays peak‑to‑peak values for EMG amplitude and latency responses for each stimulation pulse delivered. Every turquoise dot represents a single EMG amplitude response. Each blue dot represents a latency response. A red dot is an out of limit condition resulting in an alarm sounding.

Nerve Integrity Monitor

J. APS™ ON/Advanced Settings: When the APS™ ON check box is

checked (orange with white check mark) the Advanced Settings button is NOT selectable. If the APS™ button is turned OFF:

• e advanced settings button will be selectable.

• e APS™ portion of the screen (right side) will close and there will be an APS™ tab added next to the control panel tab. e operator can open and close the inactive APS™ screen using this tab.

• APS™ monitoring will resume when the APS™ check box is turned ON.

K. Latency marker: A small purple X showing where the latency value

was located on the trace. L. Time Base: see F. M. Case duration.

The Reports Mode

Note: All stored data (Snapshots) are lost when unit is powered off.

e Report Mode allows the user to quickly compose and print/save three general types of reports; Event Records, Log Files and APS™ Records. Report templates are provided to simplify creating reports. e Reports Mode can be active while audio monitoring continues in the background. All work that is performed in Reports will be saved by the system, if Reports is exited and the user returns to Monitoring. In this way, a report could be started midway through a monitoring session. When the user returns to Monitoring to complete the session, all previous work will be available when the user returns to the Reports Mode. When the system is intentionally turned o, all monitoring session data are lost. ere are three steps in the process:

• Select Report Format

• Specify Report Content

• Create Report

Reports Step 1 of 3 (Select Report Format)

is screen is used by Snapshots, Log Files, and APS™ Records.

1. Select Report Format

Select Case

Case 1 - Procedure: Mastoid

Surgeon Name: Patient Name: Notes:

Select Report Type

A. Tool Bar: Used to select any of the major (3) functional Modes. B. Active Screen Bar. Next button will be displayed aer a report type

has been selected.

C. Select Case: Select a case from multiple cases. Next and/or Previous

button will be displayed if more than one case is in memory. D. Report Type: Select from available report types. E. Sample display area of selected report type.

Snapshots/Event Reports

1. Select Report Format

Snapshots

Log Files

APS Records

Setup

Monitoring

Step 1 of 3

5/1/2009 9:00AM

Monitoring

Step 1 of 3

Reports

Information

Reports

Information

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

Setup

2. Choose Report Content

Choose Events

Event Title

Orbicular is Oculi

Orbicular is Oris

500µV

Event Comments

Unselect All

Start: 4:30AM

4:30AM

Tool Bar: Used to select any of the major (Set‑Up not available in

471µV

50µV

25 mS500µV

Step 2 of 3

Event 1 of 4

11/4/2008 6:50AM

Include In

Report

11/4/2008 10:00AM

Monitoring

Select Events

5:30AM 6:30AM

Reports

Information

Orbicularis Oculi

Orbicularis Oris

500µV

Orbicularis Oculi

Orbicularis Oris

500µV

5:15AM

6:08AM

471µV

50µV

500µV

25 mS500µV

478µV

20µV

25 mS500µV

Orbicularis Oculi

676µV

Orbicularis Oculi

Orbicularis Oris

50µV

Orbicularis Oris

25 mS500µV

1 to 4 of 4

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

Orbicularis Oculi

Orbicularis Oris

500µV

5:55AM5:40AM

End: 6:30AM

31µV

450µV

25 mS500µV

Reports) functional Modes. B. Active Screen Bar. C. Choose Events (In APS™ reports Choose Events panel is Choose

Sessions panel):

• Scroll through each captured event (captured event: whenever Snapshot Button was/is pressed) with the Previous and Next buttons.

• When an event is displayed the operator may enter or modify an Event Title or Comment.

• Selecting the check box will move the displayed event to the Selected Events panel. Events are displayed in the report in the order they are selected.

D. Select All button: Used to move all events to the Selected Events

panel (In APS™ reports there is no Select All button).

E. Time‑Line panel (In APS™ reports there is no time line panel):

• Graphically shows all the captured events and time.

• Events selected to appear in a report will be orange in color not‑ selected events will be white.

F. Selected Events: Shows the collection of events to be included in the

Report.

Snapshots/Events Reports Step 3 of 3

e third step allows the user to choose a report format and generate (print or save) the report. Depending on the report type, this step takes on dierent looks.

3. Create Report

3. Creats Report

Report Format

Setup

1 Record Per Page

Monitoring

Step 3 of 3

Reports

Information

Sample Preview

Select Case

Case 1 - Procedure: Mastoid Surgeon Name: Patient Name: Notes:

Select Report Type

Snapshots

Log Files

APS Records

5/1/2009 9:00AM

Aer the Report Type has been selected (Snapshots) the operator will press the next button in the Active Screen Bar to open Step 2 of 3 screen.

Choose Report Content Step 2 of 3

APS™ reports and Snapshot reports are very similar. e dierences are noted in the following.

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

4 Records Per Page

Case Notes

Tool Bar: Used to select any of the major (Set‑Up not available in

Reports) functional Modes. B. Active Screen Bar. C. Report Format: Select 1 record per page or 4 records per page. D. Case Notes: Add any notes to the Report Summary page. E. Report Options:

• Print button will send the report to the attached printer.

• Save button will send the report to the attached USB mass storage device. Save the formatted report, as a .pdf on the USB drive. e lenames will be formatted with the report type, year, month, day and time, for example, EventReport_20090528112530.pdf.

• Reports are located in a Case Folder titled:

• date and patient ID or

Save

5/1/2009 9:00AM

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

Nerve Integrity Monitor

• date and patient name or

• with no patient ID or name, date and sequential case number will be used.

F. Sample Preview: Displays an example of the type of report selected.

Snapshots/Events Reports .pdf Image Example

Log Files

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

Log Files Step 2 of 3

A log le that contains data for all events (not only Snapshot Events) is maintained by the system throughout the case. An event in the Log File is created when the EMG value exceeds the Event reshold value. e data in this le can be used to either construct Log File Reports or to be exported in comma‑delimited format for o‑line analysis. For a Log File Report, this wizard step allows the user to select event data using ‘data lters’.

2. Choose Report Content

Setup

Monitoring

Step 2 of 3

Reports

Note: Record 1 and 2 are “Stimulated” events with STIM1 showing 0.80/0.80mA that is the set value / by the read value. Record 3 and 4 are Non-Stimulated events with STIM1 reading

0.80/0.00mA that again is the set value / by the read value of zero.

Event Filter

Snapshot Events

All Events

Snapshot Events: 4

Stimulated Events: 0

Non-Stimulated Events: 8

No. of Sequences 4

Tool Bar: used to select any of the major (Set‑Up not available in

All Events

Selected Events: 8Total Events: 8

Stimulated Events

Non-Stimulated Events

5/1/2009 9:00AM

Event Sequences

Suquenecs Filter

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

Reports) functional Modes. B. Active Screen Bar. C. Event Filter: choose Events captured using Snapshot or All Events. D. All Events: additional lter criteria allowing the user to select

Stimulated Events, Non‑Stimulated Events, or both. Note All Events

Panel is visible only if the All Events button is pressed. E. Event Sequence: A sequence is a series of events separated from each

other by less than one second.

When the Sequence Filter is selected the user can sort event

sequences by Last or Largest:

• Last: When selected, only the last event in a sequence will be included in the report. is is the default when Sequence is selected.

• Largest: When selected, only the event that contains the greatest value within a sequence will be included in the report.

F. Status box: shows statistics about the logged events, including the

number of events that will be included in the Report (Selected Events).

Note: Case Notes are entered using any of the Case Notes text

boxes. Comments were entered when the Snapshot button was pressed or when creating the report.

Nerve Integrity Monitor

Log Files Step 3 of 3

3. Create Report

3. Creats Report

Case Notes

Setup

Monitoring

Step 3 of 3

Setup

Tool Bar: used to select any of the major (Set‑Up not available in

Reports) functional Modes. B. Active Screen Bar. C. Case Notes: Add any notes to the Report Summary page.

Save

5/1/2009 9:00AM

Reports

Sample Preview

Information

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

D. Report Options:

• Print button will send the report to the attached printer as a pdf image.

• Save button: will open a dialog box allowing the operator to send the report to the attached USB mass storage device.

Save Report Data to USB Drive

Log Reports .csv (in Excel) Example

.PDF

.CSV

.DB

Cancel

•

Save the formatted report, either to a .pdf image le, .csv

Save Image of Report (.pdf file)

Save a Data File (.csv file)

Save Database (.db file)

Don’t Save

data le or a .db database le on the inserted USB drive. e lenames will be formatted with the date and time, report type and appropriate extension. For example, LogReport_20090618081932.pdf would be a Log Report Image created 2009 June 18 at 08:19:32.

• Reports are located in a Case Folder titled:

• date and patient ID or

• date and patient name or

• with no patient ID or name, date and sequential case number

will be used.

E. Sample Preview panel will show an example of the report type prior

to saving or printing.

Log Reports pdf Image Example

APS™ Reports

1. See Reports Step 1 of 3 and select/press APS™ Reports.

• Note: Functionally APS™ Reports and Snapshot Reports use all the same screens/Panels with the same function. Please see Snapshot Reports for instructions.

APS™ Reports .pdf Image Example

Creating a Report

Snapshots Report

1. See Reports Step 1 of 3 and select/press Snapshots.

2. Choose Report Content (Snapshots) Step 2 of 3 Screen opens.

3. In the Choose Events panel:

• Using the Next and Previous buttons, select an event you wish to copy into the report.

• Press the blue arrow in the white Event Title box if you wish to title the event or modify an existing title.

• Press the blue arrow in the white Event Comments box if you wish to enter comments about the event or modify an existing comment.

Nerve Integrity Monitor

• Press the Include in Report Check Box. e selected event will appear in the Selected Events panel. or Pressing the Select All Button will move all events to the Selected Events panel. You may still use the Next and Previous buttons to move through the selected events and enter/modify event titles and comments as needed.

4. Press the Next button on the Active Screen Bar.

5. Create Report (Event Records) Step3 of 3 Screen opens.

6. Select form the Report Format panel weather you wish to view one(1) or four(4) records per page using the radio buttons.

7. Press the blue arrow in the white Case Notes box to enter any comments you have on the case.

Note: Event Title and Event Comments appear at the top and bottom of the event where the y were entered and in the Summary section of the report. Case Notes are in the Summary section only.

8. Print and Save button will open a dialog box allowing the operator to send the report to the attached USB mass storage device.

Save Report Data to USB Drive

Special Functions and Features

Visual Alarms and Warnings

e operator may encounter the following warnings and should respond appropriately.

.PDF

.CSV

Cancel

•

Save the formatted report, either to a .pdf image le, .or csv data

Save Image of Report (.pdf file)

Save a Data File (.csv file)

Don’t Save

le.

Log les

1. See Reports Step 1 of 3 and select/press Log Files.

2. Choose Report Content (Log Files) Step 2 of 3 Screen opens.

3. In the Event Filter panel:

• Select the Snapshot Events Radio button and only events that

were saved by pressing the Snapshot button on the Main Screen will be available to Step 3 of 3 in the Log File Report. or

• Select the All Events Radio button:

If All Events Radio button was selected:

• All Events, and Event Sequences panels will open.

• All Events: Stimulated and Non‑Stimulated Events are selected by default. is can be adjusted to any combination of the two if desired.

• Event Sequences: O (default) if selected operator will need

4. Press the Next button on the Active Screen Bar.

5. Create Report (Log Files) Step3 of 3 Screen opens.

6. Press the blue arrow in the white Case Notes box to enter any

7. Print and/or Save the report using the Print and/or Save buttons.

to select between Last (default) and Largest.

comments you have on the case. Case Notes are located between the End of Report and Electrode Check sections of the Log File.

Nerve Integrity Monitor

Audio – Understanding What You Hear

e NIM® 3.0 System Nerve Monitor produces many dierent sounds throughout surgical procedure that require understanding by the person performing monitoring. In addition to EMG sounds, various beeps and voices provide useful information.

Alarms

e alarms draw attention to any condition, which prevents proper monitoring. None of the audible alarms should be ignored. One must assume that valid monitoring has stopped and determine immediately why the alarm sounded. ere are three distinct alarms:

• BEEP Alarm: e high‑pitched, repetitive beep is used to register failure of internal microprocessor hardware. If you hear it at any time other than at power up, stop using the NIM® 3.0 System and contact Medtronic. See Customer Care section.

• Bleedle Alarm: is is a three‑note alarm (Blee‑Dle Deet) that cannot be disabled. It repeats until the responsible condition is remedied. e alarm is heard once under the following conditions:

• Check Electrode

• Muting

• and Power Up

• APS™ alarm: e high‑pitched three‑note alarm is used to notify the user when changes in the amplitude or latency exceed the user dened limits. ere is a delay of at least 6 seconds before this alarm will repeat.

For more information on these two conditions please see Special Functions and Features / Muting conditions.

• Voice Alarms: ere are two voice alarms that are selectable and work in unison with the bleedle alarm. ey can be turned on or o and have volume controls. ese alarms are “check electrodes” and “muting,” and are described in System Set‑Up.

Voice Annunciation

ere are several voice annunciation types, stimulation delivery conrmation, numeric stimulator current values, and activation of auto threshold.

NIM® 3.0 System Voices

Point Five reshold increased Zero Six Check electrodes One Seven Electrodes Two Eight Stimulus ree Nine Four reshold decreased

Threshold / Voice

ese voices are used as part of the Auto reshold feature when automatic adjustments are made. Please see the Auto reshold section of the manual. e NIM® 3.0 System has two (2) reshold voices: “reshold increased” ‑ “reshold decreased”.

Help / Voices

“Check electrodes” is announced when contact with an electrode is lost.

Stimulus Delivery Audio

Tone

e stimulus tone announces the delivery of current to the patient.

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

• If Brief Tone is used, then delivery of stimulus current is accompanied by a brief warbled tone.

Note: Stimulus tones will not sound for stimulus current levels below 0.05mA.

Voice

e stimulus voice announces the delivery of current to the surgical eld by voice.

• Voice ‑ Stimulus: With “Stimulus”, delivery of current to the surgical eld is announced by the word, “STIMULUS”. It may be turned on or o and has volume control.

• Voice ‑ Setting e “Setting” voice announces the value of the STIMULUS setting. It also announces any new stimulus setting when adjustments are made. Example: 0.50mA would be announced as “Point Five”. It may be turned on or o and has volume control.

Note: Voice - Setting or Voice - Stimulus will not sound for stimulus current levels below 0.05mA.

Other EMG Responses (Samples are available in the Help Screen).

• Burst ‑ Brief tone: Caused by electrical stimulation, direct nerve contact, irrigation, or thermal changes.

• Train Tones lasting seconds to minutes: Caused by nerve excited/ irritated, irrigation, drying, bumping, or anesthesia.

• Pulse ‑ Repeated tones: Caused by electrical stimulation, tumor mapping, verifying nerve integrity.

Muting

e Muting Detector is normally clamped around the active cable of an electrosurgical instrument that would otherwise be interfering with monitoring. Do not include the grounding pad cable in the jaws of the Muting Detector. It may also be connected to other equipment cables, such as electrocautery, ultrasonic debulking devices (e.g. CUSA), or other external devices, which generate interfering signals. Always attach the Muting Detector close to the output jacks of the electrosurgical or other unit rather than near the hand piece the surgeon uses. More than one output cable may be clamped within the Muting Detector jaws at one time. Monopolar Electrosurgical Instrument Clamping e following table shows the power level for satisfactory muting performance of electrosurgical unit.

Monopolar Electrosurgical Unit

5‑100W

Muting Conditions

Check Electrode:

• As soon as contact with an electrode is lost aer removal.

• e channel shows a background noise waveform.

• Aer approximately 30 seconds, “Electrode O” is displayed

in Yellow Text on a zero (0) amplitude waveform line.

• e channel will be muted until connection is restored.

Muting from External Source:

As soon as the Muting Detector senses current ow, the dialog box “ Monitoring/WARNING EMG MONITORING IS DISABLED/Muting from external source” and the system will be in mute. Aer 20 to 30 seconds, the bleedle alarm will sound followed by the “Muting” voice. e bleedle alarm will repeat every 20 to 30 Seconds until the condition is remedied.

Nerve Integrity Monitor

STIM Bur Guard

e STIM Bur Guard provides stimulating current to standard Medtronic burs in both static and dynamic modes. e STIM Bur Guard locks onto any Visao® handpiece, while the cable connects to a port on the IPC® System or XPS® 3000 (REF 1897102BF). A separate cable then connects to the NIM® Patient Interface Box. Wires within the STIM Bur Guard make contact with the uncoated bur and carry the stimulating current to the bur tip. Prior to using this device, the user must be familiar with the NIM® Systems User’s Guide, the Bur manual, the STIM Bur Guard User’s Guide, and the IPC® System or XPS® 3000 (REF 1897102BF) User’s Guide. Compatible equipment:

• XPS® Console (1897102BF)

• IPC® Console For more information related to the STIM Bur Guard system contact your local Medtronic representative

Note the following Contraindications for Use:

e use of paralyzing anesthetic agents will signicantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. Whenever nerve paralysis is suspected, consult an anesthesiologist.

Muting Detector Set-Up

See Precaution P8.

1. Open the Muting Detector jaws and insert the cable from the electrosurgical instruments, ensuring that the wire is free to move and the jaws are completely closed.

2. Route the wire straight through the clamp.

Standard clamping

System Set-Up

Operating Room Set-Up

e NIM®3.0 System Nerve Monitor has a few characteristics that need to be taken into consideration when setting up the OR. Some of these characteristics include, but are not limited to, external devices, trac patterns, sterile areas, color‑coding, grounding, and muting detection. Set the NIM®3.0 System on a table or cart located about 3 meters from the surgical eld but as far as possible from the electrosurgical unit. Also, consider trac patterns and sterile areas. e surgeon may have further preferences as to location and visibility.

Typical Set-Up (shown with IPC®)

A. Anesthesia Equipment B. IPC® System or XPS® 3000 (REF 1897102BF only) if used C. Nursing Supplies / Surgical Instruments D. Scrub Nurse E. NIM® Monitor F. Microscope G. Surgeon H. Electro Surgical Unit I. Anesthesiologist

Anesthesia Requirements

All decisions regarding anesthesia are the responsibility of the attending licensed medical practitioner administering the anesthesia. Because all intraoperative monitoring discussed in this User’s Guide requires that EMG activity be recorded from a muscle or muscles, it is important that the muscle(s) not be paralyzed during the surgery or at least during those parts of the surgery when the nerve(s) being monitored is (are) deemed at risk by the surgeon. It is important that the surgeon discuss these issues pre operatively with the attending licensed medical practitioner administering the anesthesia.

Nerve Integrity Monitor

Note: Bipolar clamping is normally not needed but if power level is

Monopolar and Bipolar (if needed) Clamping

very low it may be necessary to loop the single conductor around and through the clamp see instruction 7 for clamping instructions.

3. Slide the cable so the probe is near the main unit of the electrosurgical instruments, not near the hand piece(s).

4. Slip the upper side of the anti‑slide ring around the end of the Muting Detector to form a “U” around the cable. Pull it snugly against the probe’s lower jaws (see Steps 1 & 2).

Step 1 Step 2

5. Do not clip the Muting Detector to the grounding pad cable.

6. e Muting Detector and Patient Interface cables should be secured to the oor with tape or other non‑slip/trip device.

e auxiliary jack marked AUX (‑) can be used (with a universal handle) if more than one stimulator probe is required. In such a case, both the probes share the same stimulator settings and can be adjusted with the incrementing probe handle or touch screen stimulus adjust.

7. For very low power levels it may be necessary to loop the single conductor around and through the clamp once.

Patient Interface Set-Up

Prior to surgery, the Patient Interface and Stimulator must be setup. is may be done prior to the NIM®3.0 System being turned on, or the NIM®3.0 System may be used to support the process of determining which nerves to monitor and positioning the electrodes appropriately (see Electrode placement in Special Functions and Features). Clip the Patient Interface near the surgical site within reach of the sterile electrode leads and sterile stimulator cable(s). Position it so that it is out of the way of the doctor and the scrub nurse. Placement of electrodes should be performed by or under the direction of a licensed medical practitioner who determines the particular nerves that are at‑risk with each particular patient and procedure. e physician then places electrodes in the muscles innervated by the nerves at‑risk. e electrode sites should be cleaned with alcohol to remove oils from the skin. e electrode needles are inserted into the patient, taped into position, and the wires routed away from where the surgeon will be working. Usually, recording electrodes are placed before the sterile eld is draped and dened. Never let electrode leads contact one another. Two electrodes per monitoring channel and one ground are required. e electrode pairs for each channel plug into color‑coded input jacks on the patient interface. Route the white (+) stimulus return wire (monopolar) away from the channel electrode wires. If/when wires must cross; they should cross at right angles. Never run other operating room cords/cables parallel to any of the NIM® 3.0 System wires. Verify the electrodes are properly inserted by turning on the NIM®

3.0 System and looking at the Electrode screen. is may determine

if electrodes need to be re‑inserted for better electrical contact to help optimize monitoring. Lay the Patient Interface cable out of busy trac patterns and secure it to the oor as needed.

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black).

C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM1 Stimulator Return (anode). F. Stimulator Output (cathode). G. Remote Stimulus Control. H. Monopolor Probe with Remote Stimulus Adjust (Incrementing

Probe) Handle. I. Operated Side.

Note: The Incrementing Probe connector (A) has three indentations in the connector sleeve and one off center key that mu st be aligned with the Patient Interface connection (B) or the connector may be damaged. Align arrow (C) on side of Incrementing Probe connector w ith key symbol on Patient Interface .

Monopolar Probe with Universal Handle

Patient Interface and Single Stimulators

e NIM® 3.0 System Stimulator output supports the use of both monopolar and bipolar stimulating probes with a range of 0‑30mA.

Note: The NIM-Neuro® 3.0 Patient Interface shown here is for reference only. The NIM-Response® 3.0 Patient Interface is used in the illustrations in this section. ALL connections are the same.

Monopolar Incrementing Probe

e (single use) Incrementing Probe provides the surgeon with the means to adjust the stimulation current and print or save the monitoring screen at the surgical site. e patient interface will support one incrementing probe. e smaller plug is color‑coded black and plugs into the black (‑) jack on the patient interface. e larger plug is also color‑coded black and plugs into the large black (STIM CONTROL) jack on the patient interface. e monopolar stimulating probe delivers current to the patient and acts as the cathode. e red electrode with white wire (+) is required for monopolar stimulation. It is referred to as the stimulus return or anode. Plug the red connector of the red electrode with white wire into the white jack with a red ring (+). Route the white (+) stimulus return wire away from the channel electrode wires.

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black). C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM1 Stimulator Return (anode).

Nerve Integrity Monitor

F. Stimulator Output, Monopolar Probe and Universal Handle

(cathode). G. Operated Side. e patient interface supports one or two single use probes. e handle plug is color‑coded black and plugs into the black (‑) jack on the patient interface. e monopolar‑stimulating probe delivers current to the patient and acts as the cathode. e red electrode with white wire (+) is required for monopolar stimulation. It is referred to as the stimulus return or anode. Plug the red connector of the red electrode with white wire into the white jack with a red ring (+). Route the white (+) stimulus return wire away from the channel 1‑8 electrode wires. e auxiliary jack marked AUX (‑) can be used if more than one stimulator probe is required. In such a case, both the probes share the same stimulator settings.

Bipolar Probe

B. Negative Electrode Jacks (electrode plug matches color and wire is

black).

C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM2/APS™ Stimulator Return (anode). F. APS™ Electrode Stimulator Output (cathode). G. Operated Side.

Patient Interface and Stimulator Combinations

Note:

• In previous versions of the NIM® STIM1 and STIM2 were wired in parallel (any signal applied to one was applied to both). e NIM® 3.0 STIM1 and STIM2/APS™ are wired independent of each other with each requiring an output (stimulator) and a return (red electrode with white wire).

• By default STIM1 is on and STIM2 is o (except for procedure “yroid with APS”). STIM2 must be turned on manually. See Monitoring Mode or Set-Up Mode.

• By default STIM1 and 2 are Monopolar Probes and must be changed manually for Bipolar. See Advanced Settings.

Monopolar Incrementing Stimulator and APS™ Electrode Stimulator

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black).

C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM1 Stimulator Return (anode). F. Stimulator Output (cathode). G. Single Use Bipolar Probe and Handle.

Note: By default Monopolar (STIM1 and STIM 2) is selected in the Type Panel (located in the Advanced Set tings/Stimulation Panel). The operator should change this to Bipolar.

H. Operated Side. When bipolar stimulation is required, only one probe can be used. e stimulator connection uses two dierent diameter pins to connect to the cable. e cable to patient interface uses color‑coded connectors (Green wire with a red plug, connecting to the white jack (+) with a red ring, and black plug connecting to the black (‑) jack). e black AUX (‑) jack cannot be used in this application.

APS™ Electrode Stimulator

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black).

C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM2/APS™ Stimulator Return (anode). F. Stimulator Output, APS™ Electrode (cathode). G. Remote Stimulus Control. H. Stimulator Output (cathode). I. STIM1 Stimulator Return (anode) Probe. J. Operated Side.

A. Paired Electrodes.

Nerve Integrity Monitor

Monopolar Probe and Stimulus Dissection Probe

Monitor Set-Up

e NIM® 3.0 System has a large number of user selectable characteristics used during a typical setup procedure. is section will address the three most common types of setup procedures:

• “Basic” Set‑Up. Basic information used by all programs i.e. Time and Date.

• “Standard” Set‑Up that uses a factory loaded program.

• “Custom” Set‑Up. is allows the surgeon to dene the surgery being performed and the nerves to be monitored.

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black).

C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM2 Stimulator Return (anode) Probe. F. Stimulator Output, Monopolar Probe with Universal Handle

(cathode). G. Stimulator Output, Stimulus Dissection Probe and Cable (cathode). H. STIM1 Stimulator Return (anode). I. Operated Side.

Bipolar and Monopolar Probe

A. Paired Electrodes. B. Negative Electrode Jacks (electrode plug matches color and wire is

black). C. Positive Electrode Jacks (electrodes plug and wire are the same

color). D. Electrode Ground. E. STIM1 Stimulator Return (anode). F. Stimulator Output (cathode). G. Bipolar Probe and Handle.

Note: By default Monopolar (STIM 1 and STIM 2) is selected in the Type Panel (located in the Advanced Set tings/Stimulation Panel). The operator should change this to Bipolar.

H. Operated Side. I. Stimulator Output, Monopolar Probe with Universal Handle

(cathode). J. STIM2 Stimulator Return (anode) Probe.

Basic Set-Up All Procedures

Read this section while viewing “Set‑Up Mode”.

1. Connect unit to AC power.

2. Turn power switch to the On position.

3. Aer self test is complete press the “Global Settings” button.

4. Select Language (English is default).

5. Select “Time/Date Format”.

6. Press “Set Date and Time” button keypad will open.

7. Touch the text eld for “Date:” and using keypad buttons enter date.

8. Touch the text eld for “Time:” and using keypad buttons enter time.

9. If formatted for AM/PM then select AM or PM.

10. “Clear” button will clear selected text eld, “Apply” button will enter new time and date, “X” button will exit keypad.

11. In the “Data Fields for Case Notes” there are six (6) selectable predened text elds and two (2) user denable text elds. a. Select any combination of “Data Fields”. b. Pressing on the text eld (<title>) will open a keyboard to enter a

“Title” for the user denable text eld.

12. Press “OK to close “Global Settings Panel”.

Standard Set-Up

Read this section while viewing “Set‑Up Mode, and Patient Interface Set‑Up”.

1. “Select Procedure” screen. a. “Neuro/Otology, Head/Neck, and Peripheral” each open

drop‑down menus of predened procedures.

b. Select by pressing the desired procedure.

2. At this point the “Place Electrode” screen will open. a. If patient interface is not connected then connect it now (see

Console Rear).

b. Connect electrodes according to graphic display (both patient

interface and patient).

c. Connect stimulation probe (see Patient Interface Set‑Up).

3. Review the “Check Electrodes” panel. All electrodes including STIM1/2 and ground have green check marks. If not see “Electrode Troubleshooting Guide”.

4. To change electrode type: a. Press the “Show Details” button. Each channel will show a button

with the muscle group being monitored and the electrode type.

b. Press the channel button. A drop‑down menu will open showing

available electrodes.

c. When you select the electrode the menu will close.

5. In the “Place Electrodes” tool bar press the “Next” button.

6. “Enter Case Information” screen will open. a. Press on the desired text eld. b. A keyboard will open for entering text. c. When text has been entered press “OK”. d. Continue in this fashion until all text elds are complete.

7. Press the “Monitor or Monitoring” button.

Custom Set-Up

Read this section while viewing “Set‑up Screens, Panels, and Patient Interface Set‑Up”.

1. “Select Procedure” screen press “Custom Procedure”.

2. Drop‑down menu will open, press “New”.

3. Keyboard will open, enter name of custom procedure. Press “OK”.

4. e new procedure will appear as a button in the “Custom Procedure” drop‑down menu.

5. Press the new procedure button.

6. At this point the “Place Electrode” screen will open. a. If patient interface is not connected then connect it now (see

Console Rear”.

b. Connect electrodes according to the surgeons directions as the

graphic display is blank/not helpful.

c. Connect stimulation probe (see Patient Interface Set‑Up).

7. Review the “Check Electrodes” panel. a. To change electrode type:

Nerve Integrity Monitor

i. Press the “Show Details” button. Each channel will show a

button with 1‑Channel 1, 2‑Channel 2 etc. and the electrode type as subdermal.

ii. Press the numbered channel button. A drop‑down menu will

open showing available electrodes. When you select the electrode the menu will close. All electrodes including STIM1/2 and ground have green check marks. If not see “Electrode Troubleshooting Guide”.

8. Press the “Check Electrode” tab. e electrode panel will close.

9. Press the “Procedure Settings” tab. e procedures setting panel will open.

10. To assign muscle group names to the channels: a. Press the “Channels” button. b. Channels can only be named when they are “Inactive” press any

active channel once to inactivate it. c. Press the “Inactive” button. Keyboard will open. d. Enter channel name. e. Press OK. f. When all channels are complete press the “Channels” button to

close drop‑down menu.

Note: At this point the operator may choose to save this procedure or see “Additional Settings”.

Additional Settings

If changes to Stimulus, Event Capture, Audio Settings, Monitoring Settings, Stimulation Settings, Microscope Settings, or APS™ Settings are to be a permanent part of a “Custom” procedure they must be done at this (Procedure Settings/Advanced Settings button) panel. When Advanced Settings is accessed from the “Control Panel” tab, the changes cannot be saved and are used only in the current session. When the Advanced Settings button is pressed, a screen is opened with tabs that allow access to the functions described in the “Panels/ Advanced Settings” section of this manual.

For Installing the Stimulating Electrode

See Instructions for Use included with your electrode set.

APS™ Monitoring

1. Press the “Baseline” button on the le side of the Monitoring Screen. A dialog box will open showing Baseline data and progress. Upon successful completion of the “Baseline” function, an Accept, Repeat or Cancel button will be displayed. is allows the operator to Cancel or Repeat the the Baseline operation. If Accept is selected the Dialog box will close.

2. e selected APS™channel will be displayed on the right half of the monitoring screen. If no channel was selected then all channels will show a Baseline and Limit Lines on the right half of the monitoring screen.

Note: all channels are selected by default (up to 4 max).

3. e Baseline will appear as a white line and the trend limit as a red line for both the EMG Amplitude and Latency values.

4. Each APS™stimulation pulse will result in a blue dot (EMG) or turquoise dot (latency) on the Baseline.

5. Should a stimulation pulse occur at or outside a trend limit line, a red dot will be placed at the location and an alarm will sound. e alarm is meant to draw attention to any condition, which prevents proper monitoring. Any Alarms should not be ignored. User must assume that valid monitoring has stopped, determine immediately why the alarm sounded, and make any required adjustments to resume valid monitoring or address the situation.

Changing APS™ Settings

1. Press the APS™ ON check box (from orange with white check mark to blue with no check mark):

• APS™ monitoring will stop.

• Advanced Settings button will change from grey to blue.

2. Press the Advanced Settings button.

• See Panels/Advanced Settings.

• Adjust Event reshold. See Main Display.

3. Aer modifying the APS™ settings you must acquire a new Baseline. See APS™ Monitoring.

Surgery Notes

• Use of a stimulating probe is encouraged during surgery in

conjunction with APS™ monitoring.

• When using the NIM® EMG endotracheal tube for APS™ monitoring, tube movement or mucus buildup during surgery can reduce APS™ responses, requiring the need to acquire a new baseline.

• A decrease in the EMG amplitude (greater than the alarm limits) may occur when performing APS™ monitoring lasting longer than four hours. Acquiring a new baseline may be needed if this occurs. Please note that stimulating the nerve for up to 8 hours poses no signicant risk of nerve injury.

After Surgery

Removal (APS™ Electrode) is the reverse of installation. See Instructions for Use included with your electrode set.

When the Case is Complete

Before closing the surgical site, the surgeon should evaluate the nerve’s functional integrity one more time. is can be done by stimulating the nerve both proximal and distal to the immediate dissection area as far as is accessible within the surgical eld. Use the lowest level of stimulation that produces a response. Continue to monitor with the NIM® 3.0 System throughout the procedure (until the incision is closed), since items such as wound dressings might exert stress or pressure on the nerve and aect its function.

When Monitoring is Complete

Turn OFF the power to the NIM® 3.0 System when the entire procedure is completed, and have the licensed medical practitioner remove the electrodes from the patient. Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard container in accordance with hospital or other user facilities policy.

Power Disconnection

To disconnect equipment from the power, remove power cord from the supply receptacle.

Note: All stored data (Snapshots) is lost when unit is powered off.

Cleaning and Maintenance

Cleaning (after each use)

e patient simulator, patient interface and cable, Muting Detector and cable(s), printer, printer cable, power cords, headphones, USB compact ash, and the NIM‑Neuro® 3.0 System monitor

• Disconnect all cabling from rear of the monitor.

• DO NOT immerse or sterilize the units.

• Wipe down the units with a cloth dampened with a neutral enzymatic detergent, pH 6.0‑8.0 or phenol based disinfectant.

• Do not use alcohol, other solvents, or abrasive cleaners.

• Dry the units with a clean, non‑abrasive cloth.

Storage

Allow the NIM® 3.0 System and accessories to thoroughly air‑dry before storing in a cool dry place. See Technical Specications for further information.

Maintenance

Medtronic Xomed is committed to provide the highest standard of workmanship in manufacturing its products. Your NIM® 3.0 System requires minimal maintenance and calibration. However, Medtronic Xomed recommends preventative maintenance and screen calibration scheduled at yearly intervals. Comprehensive testing and calibration should be performed by returning the entire system, including the patient interface and Muting Detector to Medtronic Xomed Customer Care. Contact them directly for details of how to return your product.

Nerve Integrity Monitor

Fuses

Console Replacement

e console AC power is fuse protected. Have a Biomedical Engineer check the fuse if a problem is suspected. It is very important that the correct replacement fuse is used (5 x 20mm, 2.5 Amp, time‑lag, Low breaking capacity, Xomed Fuse Kit # 8253070).

Nerve Integrity Monitor

Patient Interface Replacement

e Patient Interface has its own fuse. It is very important that the correct fuse is used – It must be Xomed Fuse Kit # 8253075 (similar 32mA Type F250V 5 x 20mm fuses may not oer the same degree of protection).

STIM 1

STIM 2

STIM 1

STIM 2

Nerve Integrity Monitor

Troubleshooting

Symptom Cause Solution

No visual display or audio alarms at power‑up.

Electrode impedance is too high. > 10KΩ for subdermal electrodes. > 25KΩ for Prass paired electrodes. > 5KΩ for EMG tube. > 40KΩ for hookwire electrode.

Electrode impedance ≤0.1KΩ

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

Electrode dierence is greater than 2KΩ (Subdermal electrodes) or 10KΩ (Prass Paired electrodes).

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

Interference on anesthesia equipment (EKG Monitor).

Incrementing Probe will not adjust stimulation.

Stimulus keeps changing (run away). Bad Incrementing Probe.

Electrosurgical interference.

Excessive Muting.

Rhythmic Artifact. Pacemakers – Pace Pulse.

Inadequate muting.

No response to direct stimulation.

Power cord not connected to outlet or to the NIM® 3.0 system. Power switch not turned on.

Electrode dislodged from patient, but not completely out. High resistance in electrode. Remove and replace with new 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. Check connection to Patient Interface box.

Dirty electrode. Mismatched pair.

Unequal placement. No channel electrode connected. Ground not connected.

Measuring current on NIM® EMG Electrodes. Try an alternate EKG Lead set. Electrode Check (Electrode Screen selected). Deselect Electrode Screen. Muting function active. See Excessive Muting (Symptom Column). With Stimulator active. Turn the NIM® Stimulator to 0.0mA when not needed.

Loose connector.

Muting Detector Probe not connected. Check Muting Detector Probe connections. Muting Detector Probe input insucient. Loop the unit cable through muting detector. Electrosurgical grounding inadequate. Check electrosurgical grounding pad on patient.

Source of interference unidentied.

NIM® 3.0 system or Patient Interface cable too close to electrosurgical unit or its cables.

Unit receiving excessive signal into the Muting Detector Probe or electrode leads.

Signal from electrosurgical unit inadequate to cause muting. Inadequate stimulus intensity. Increase stimulus intensity. Paralyzing anesthetic in use. Eliminate paralyzing anesthetic.

White Stimulation (+) electrode has fallen out or is not connected.

Probe (electrode) not connected. Check stimulator anode (+) and cathode (‑) connections. Patient safety fuse blown. STIM1 (EMG) Patient Interface fuse REF

8253075. Not holding probe on nerve long enough. Hold probe tip to nerve for at least 1 second.

Nerve not contacted. Volume control too low.

Event threshold set too high. Excessive current shunting in surgical eld. Remove uids from surgical stimulating area. No electrodes in innervated muscle tissue. Nerve not stumbled.

Plug in power cord. Turn power switch on.

Insert dislodged electrode; tape down in place.

Check connection at Patient Interface box.

Remove and relocate electrodes. Use “tap test” near electrodes to evoke EMG or artifact

(increase threshold, decrease volume for test). If activity is noted on channel in question, proceed.

Re‑insert electrode in question.

Remove and replace electrode in question.

Remove and replace electrode for appropriate channel with highest impedance reading rst.

Remove and replace electrode in question. Connect at least one channel electrode.

Connect ground.

Check connector is properly aligned and fully seated (See System Set‑Up / Patient Interface Set‑Up). Replace Incrementing Probe or disconnect STIM CONTROL connector and manually adjust stimulus at touch screen.

Identify source of interference; then eliminate or separate from the NIM® 3.0 system. Maintain separation between electrosurgical cable and the NIM® system. For less coupling, coil up the Muting Detector Probe next to the NIM® 3.0 system.

Disconnect the muting detector completely. Relocate electrode ground and stimulus return to patients

shoulder (Acromion). Loop the electrosurgical unit cable and clip the muting detector over the doubled cable.

Check that Stimulus Measure is approximately the same value as the Stimulus setting. Re‑insert electrode in question.

Check fuse in STIM1 (EMG) Patient Interface Replace if necessary.

Check stimulator tip for obstruction. Replace if necessary. Check location of stimulation. Check and correct all settings volume, event threshold, stimulus intensity.

Place channel electrodes in muscle to be monitored. Check EMG tube placement if applicable.

Nerve Integrity Monitor

Unexplained continuous “train” EMG response.

Nerve or monitoring area being stimulated or

manipulated by thermal or mechanical means. Unexpected responses when not directly stimulating nerve.

Metal‑to‑metal discharge artifact.

Intertwined recording electrode and stimulator

wires.

Inadvertent manipulation of electrode wires,

Patient Interface cable, or recording area on

patient.

Electrical interference from other equipment.

Technical Specications

Physical Dimensions

Operational Environment

Transport and Storage Environment

Amplier

Impedance Measurement

Artifact Detection and Rejection

Display / Touch Screen

Patient Interface

Stimulator 1 and 2

Size: 30cm W x 33cm H x 27cm D Weight: 6.8Kg

Operating Temperature range: 10 to 40ºC (Operating) Humidity: 30‑70% RH non‑condensing Atmospheric Pressure range: 700kPa to 1060kPa Mode of Operation: Continuous duty

Shock and Vibration Veried to Standard ISTA 2A Ambient Temperature range: ‑ 40°C to + 70°C Relative Humidity range: 10% to 100%, including condensation Atmospheric Pressure range: 500kPa to 1060kPa

NIM‑Response® 3.0 Ch. 1‑4 NIM‑Neuro® 3.0 1‑8 Individually and simultaneously selectable. Input Sensitivities: 5 – 10,000µV peak‑to‑peak AC‑coupled Sensitivity Selection: Automatically zeroed Bandpass: 15Hz ‑ 1.85kHz (± 3db @ 500Hz) EMG Display 200Hz ‑ 1.0kHz (‑6, +3db @ 500Hz)

Input Noise: 3‑14µV p‑p, < 5µV RMS @ RMS ‑ 4Hz, inputs shorted Input Impedance > 10Meg Ohm DC oset Rejection ± 1.00VDC Rejection Common Mode Rejection: >80dB @ 60Hz, balanced inputs, >66dB @ 60Hz, 1KOhm imbalance

Channel Enable/Disable Controls: Dedicated function touch pads for independent Ch. enable/disable. Event reshold Control and Display: Adjustable Graduated Touch Bar with Voltage threshold displayed. Patient Isolation 1,000Vrms 60Hz < 100µA

Control: Automatic CHECK ELECTRODE feature. Measuring Signal: 10mV peak‑to‑peak, 800Hz Sinewave. Measurement Range: 0‑200KOhm ± 20% or ± 100Ohm.

Stimulus Artifact: Synchronized and adjustable muting. Bipolar Electrocautery Rejection: Continuous Monitoring During Bipolar Cautery < 40 watts Electrocautery (ESU) Interference: Automatic detection, and muting. Muting Detector Input ESU Sensitivity: ESU Cut / Coag Contact 5 ‑ 100 Watts Air‑Discharge 10‑100 Watts Muting Console Input Sensitivity: Muting (0.6 ‑ 2.0 Vrms) Non‑Muting (<0.3Vrms) Muting Detector Input ESU Immunity: ESU < 100 Watts Cut / Coag or (<3.0Vrms 100‑800KHz Sq. Wave) Electrode Lead O:

Type: High contrast, digital, graphic Color, visible in complete darkness. Resolution: Display 1024H x 768W pixels, Touch Panel 256H x 256W Dedicated Function Event Touch Screen Controls: For Amplitude, Time Display and Capture. Vertical Display: 20, 100, 500, 1000, 2000, 10,000, 50K, and 100KμV display modes. Event Capture: Enable/disable capture mode indicator on touch screen. Time Scale: 25mS, 50mS, 100mS or 20S display modes.

Color Coded Channel Connections – 1 to 8:Neuro 8 CH Response 4 CH Pulse 2 CH Low Cable Triboelectric < 100 µV from a 0.5J impact Internal Fuse See Stimulator 1 and 2 “Internal Fuse”

Stimulus Type Constant: Constant Current

Identify and eliminate possible source of “train” stimulation: Cold irrigation. Laser heat. Retraction on nerve or muscles being recorded. Patient waking from anesthesia. Nerve drying. Ultrasonic aspirator. Identify and eliminate source of inadvertent manipulation. Determine response type from waveform pattern on 50ms screen.

Disentangle recording electrode and stimulator cables.

Check area near recording electrodes for excessive stretching from tape, drapes, etc.

Check for intermittent stimulation from anesthesiologist (i.e., hand‑held electrical stimulator). Move NIM® 3.0 system away from source of interference. Make sure Patient Interface cable and electrode wires do not cross other electrical equipment or cables.

Audio EMG Speaker

Automatic detection, muting and warning in approximately 30 seconds, (but within 70 seconds).

“Touchproof Safety Connection Protected Pin 1.5mm per Specication: DIN 42 802”

Nerve Integrity Monitor

Stimulus Range 0‑30mA, a minimum of 80 volts compliance (80V‑ 10%) tested into a 10KOhms load Load Impedance Range: As long as the load impedance X stimulation current is less or equal the compliance voltage Stimulus Control: Digitally controlled, range – dependent adjustment increments of 0.01, 0.05, 0.1, .5 and

Stimulus Output Accuracy: ± .01mA (or ± 10% of reading at 1K Ohms load) over Stimulus Range. Stimulus Adjustment: Graduated Touch Screen Control with display of command current and delivered

Stimulus Measurement Accuracy ± .02mA (or ± 10% of reading at 1K Ohm load) over Stimulus Range. Internal Fuse 32mA Type F, 250V 5 x 20mm (It must be Xomed #8253075, other similar fuses may

Stimulus 1 and 2 Characteristics

Waveform: Monophasic, square pulse, no DC component Duration: Soware selectable, 50, 100, 150, 200 or 250μs (± 10% of setting) Rise Time to 30mA: Less than 10μs Rate STIM1 and 2: Soware selectable, 1, 4, 7 or 10Hz (±10% of setting) Rate STIM2 APS™ STIM repetition rates: (Slow) 1, 2, 4, 8, 10 per minute, (Fast) 1, 2Hz (±10% of setting) (APS™ feature NOT

Stimulus Probe: Monopolar (standard) or bipolar Stimulus Trigger Input TTL compatible remote switch for Selection of APS™: OFF, SLOW, and FAST repeating

Audio Output

Transducers: Built‑in 7.62 x 7.62 cm speaker Piezoelectric Sounder Baseline Audio Sound Level 63 ± 4db SPL C Weighted (30.5cm) Change in Baseline with added Channels < ± 4db SPL C Weighted (30.5cm) Change in Baseline due to EMG and Tones > + 20db SPL C Weighted (30.5cm) Max Audio Sound Level 102 ± 4dB SPL C Weighted (30.5cm) EMG & Event Tone Signals: Continuously processed EMG and/or activity‑level dependent event tones for each

Volume Preset and Limiter: Volume Power Up Pre‑set Default and a Low Volume Limiter. Volume Presets for Main,

“Current Delivered” Tone Signals: Signal occurs when 80% of set current is measured over range of 0.05‑30mA. Power‑Down / Power‑up Tone Constant Power‑up / Decaying Power‑down Tone Touch Screen Key Click: Selectable ON/OFF Connection: RCA Phone Jack Headphones: Impedance @1KHz is 25Ω or greater SPL 107 ± 4dB. Plug 3.5mm Stereo Nickel Plated Headphone Output: 60 to 83dB ± 6dB SPL C‑ Weighted

Video, Audio, and other Accessories Veried Compatible

Headphones: Radio Shack Headphones P/N 33‑1223 (Sennheiser P/N HD497) Audio Amplier: Radio Shack Volume Amplier P/N 33‑1109 Radio Shack Audio Extension Cable: Radio Shack 4.8768m Shielded Audio cable P/N 42‑2493 Radio Shack Remote Monitor: 8.4” TFT ‑ Mini‑Screen with Cable (Medtronic 8253010) Keyboard: Medical Grade Keyboard (Medtronic 8253030)

I/O - Printer Output / Flash Drive Output

Printer Interface: Currently only Hewlett‑Packard D6940 printer Connection: USB 2.0

Printer Veried Compatible

Printer: Hewlett‑Packard: Model: DeskJet D6940 printer Printer Power Supply NIM® Printer Medical Grade Power Supply (Medtronic 8253025)

Data Output Veried Compatible

USB Compact Flash Memory SanDisk Brand Cruzer Mini SanDisk Brand Cruzer Micro

Video Output Microscope Overlay

Interface: Resolution 640x480 (VGA), 800x600 (SVGA), and, 1024 x 768 (XVGA) Connection: 15‑pin HD

Remote Monitor

Interface: XVGA Compatible, 1024 x 768 resolution Connection: MDR “Mini D Ribbon”

Electrical

Input Voltage 100V, 120V / 230V Frequency 50/60Hz Total Power Consumption: 62W Nominal <78W Peak (Total 33W Console, 10W Printer, and 19W Mini‑

Auxiliary AC output (For Use With Approved NIM® Accessories Only): Line Isolation: 4000V Peak‑to‑Peak 60Hz dielectric withstand from Line Connections to Signal Ground Internal Fuse 5 x 20mm, 2.5Amp, 250V, Time‑llag, Low breaking capacity, Xomed Part # 11270068.

Patient Connections All patient probes and electrodes are Type BF applied parts Patient Isolation 90‑264Vrms 50‑60Hz < 100µA (Mains on applied part N.C.) Patient Connection Capacitance 140pF +/‑ 30% @ 1kHz (All patient probes and electrodes combined to Safety GND)

Classications:

Type of Protection against electrical shock: Class I Medical Device per IEC/EN60601‑1:1988/A1:1992/ A2:1995/A:13:1995 Degree of protection against electrical shock:. Type BF applied parts Incress of water, dust, or solids IEC 60529 IPX1 Use with ammable anesthetics mixtures, with air, oxygen, and nitrous oxide:

100 ‑ 10K Ohms (0 ‑ 3mA): Compliance 10V (3.5 ‑ 30mA): Compliance 60V

1.0mA

current.

not give the same degree of protection. Order 8253075 Fuse Kit for replacements.

available on the NIM‑Pulse® 3.0)

sequence (NOT for NIM‑Pulse® 3.0)

channel.

Tones, Voices, and EMG Volumes

Screen) NIM® Printer Power Supply (# 8253025)150VA Max.

Order 8253075 Fuse Kit for replacements.

Not suitable for use in the presence of ammable anesthetic mixtures.

Nerve Integrity Monitor

Appendix A Accessories / Parts List

System Components & Accessories

Note: Please refer to ENT Product and Instruments Catalog for a complete listing of available products.

P/N Description P/N Description

8253401 NIM‑Neuro® 3.0 Mainframe 8253001 NIM‑Response® 3.0 Mainframe 8253402 International NIM‑Neuro® 3.0 Mainframe 8253002 International NIM‑Response® 3.0 Mainframe

8253410 NIM‑Neuro® 3.0 Patient Interface Box 8253200 Patient Interface Box, Response® 3.0 8253070 Fuse Kit, NIM® 3.0 Mainframe, 2.5Amp 8253600 NIM® 3.0 Universal Patient Simulator 8253075 Fuse Kit, NIM® 3.0 Patient Interface, 32mA 8253027 Printer Package, NIM® 3.0 System 8253010 Surgeon Mini Screen 8253030 Keyboard 8253080 Cable to Surgeon Mini Screen 8253015 Cable to Microscope 8220325 NIM® Muting Detector 8253085 Video/Audio Recording Adaptor Kit, NIM® 3.0

8229306 EMG Endotracheal Tube Reinforced 6mm 8229506 NIM® EMG Endotracheal Tube, Reinforced Contact Tube 6mm 8229307 EMG Endotracheal Tube Reinforced 7mm 8229507 NIM® EMG Endotracheal Tube, Reinforced Contact Tube 7mm 8229308 EMG Endotracheal Tube Reinforced 8mm 8229508 NIM® EMG Endotracheal Tube, Reinforced Contact Tube 8mm

8225101 Standard Prass Flush‑Tip Stimulator Probe, 5/Box 8225276 Ball‑Tip Monopolar Stimulator Probe 2.3mm, 1/Box 8225110 Standard Prass Flush‑Tip Stimulator Probe, 10/Box 8225278 Ball‑Tip Monopolar Stimulator Probe 1mm, 10/Box 8225103 Slim Prass Flush‑Tip Stimulator Probe, 5/Box 8225251 Ball‑Tip Monopolar Stimulator Probe 2.3mm, 10/Box 8225105 Slim Prass Flush‑Tip Stimulator Probe, 10/Box 8225051 Yingling Flex‑Tip Monopolar Stimulating Probe, 5/Box 8225275 Ball‑Tip Monopolar Stimulator Probe 1mm, 1/Box 8225277 Monopolar Stimulator Handles, 10/Box 8225825 Incrementing Probe with Standard Prass Tip 8225490 Incrementing Probe, Ball Tip 1mm 3/Box

8225351 Concentric Bipolar Stimulating Probe, 5/Box 8225401 Side‑by‑Side Bipolar Stimulating Probe, 5/Box 8225451 Prass Bipolar Stimulator Probe, 5/Box

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

8228052 APS™ Electrode, 2mm 8253054 APS™ Electrode Handswitch, NIM‑Response®/NIM‑Neuro® 3.0 8228053 APS™ Electrode, 3mm

8227301 25mm, Protected Pin, 5 Pkg/Box 8227307 38mm, Protected Pin, 5 Pkg/Box 8227304 18mm, Protected Pin, 5 Pkg/Box

8227421 Subdermal Needle Twisted Pair Electrodes 4 channel 8227103 Subdermal Needle Electrodes 12mm 8227422 Subdermal Needle Twisted Pair Electrodes 8 channel 8227450 Paired Electrodes, Gray, Prot. Pin 8227410 Paired Subdermal Electrodes 2 channel 1set/box 8227465 Paired Subdermal Electrodes 25/box 8227411 Paired Subdermal Electrodes 4 channel 1set/box 8227466 Paired Subdermal Electrodes 25/box 8227412 Paired Subdermal Electrodes 8 channel 1set/box

8226326 EMG Paired Hookwire Electrode, Protected Pin 8226626 EMG Single Hookwire Electrode, Protected Pin, 6/Box

1352400 Stimulus‑Dissection Instrument Set, 1Set 1353400 Neurotologic Stimulus‑Dissection Instrument Set, 1Set 1352415 Cable, Protected Pin, 1Ea.

8253020 Cart, NIM®3.0 System 8253035 Storage/Carrying Case

Additional information can be found at USA www.mcatalogs.com/ent OUS www.mcatalogs.com/ent‑ous/

Mainframe Accessories

EMG Endotracheal Tubes

Monopolar Stimulating Probes

Bipolar Stimulating Probes

Power Cords

APS™Electrodes

Prass Paired EMG Electrodes

Subdermal Needle Electrodes

EMG Hookwire Electrodes

Stimulus Dissection Instruments

Storage Case/ Stand

68E4004 Minimization of Pacemaker Pacing Artifacts displayed on the NIM® monitor screen.

Nerve Integrity Monitor

Appendix B Annual System Quick Check

Preventive and Corrective Maintenance

User maintenance for the NIM® 3.0 is limited to visual inspection before use and periodic cleaning. Annual “System Quick Check” with Simulator and System Safety Checks according to IEC/EN60601‑1 is recommended. Please see Warning W14.

Model # ____________ S/N _____________________ Tester _________________________ Date _______________

A. System Quick Check with Simulator (A. a ‑ f) ________( )

Use Patient Simulator to conrm appropriate behavior. Refer to the Patient Simulator Appendix C to conrm the following:

a. System Set‑Up b. Conrming Electrodes _______ c. Electrode Lead O _______ d. Mechanical Stimulation _______ e. EMG Stimulating and Tones _______ f. reshold Increase Test _______

System Safety Check according to IEC/EN60601‑1 Medtronic Xomed recommends System Safety Checks to be scheduled at yearly intervals. IEC/EN60601‑1 Safety Analysis In accordance with local procedures, perform a complete Safety Analysis for a Class 1, Type BF Device on the NIM® Console. Utilize “Ground” connector found on rear of console as Chassis ground. For Patient Leakage and Mains on Applied Parts tests, a Patient Interface must be attached to the NIM® Console with electrodes connected to each channel. Ensure Ground Impedance is less than 0.252 Ωs when measured with a 25 Amp source. Record in (a) below.

1. High Potential (Hi‑Pot) Testing (A.1.a ‑ c) ________( )

In accordance with local procedures, perform the following Hi‑Pot tests on the NIM® Console.

Note: Per form Test at voltages indicated and record values in space as needed.

Safety ground to Line/Neutral: Apply Hi‑Pot to Line and Neutral of Power Inlet of NIM® Console while monitoring Ground. Applied Parts to line/neutral: Apply Hi‑Pot to Line and Neutral of Power Inlet while monitoring Applied Parts. Precaution: Use DC voltage only when performing Applied Parts Hi‑Pot test. AC Hi‑Pot voltage to Applied Parts will damage the device.

System Safety Check Manufacturers Specications Recorded Value

a. Ground impedance <0.252Ω @ 25 Amps ______________ b. Safety ground to Line/Neutral <5.0 mA @ 1500 Vac ______________ c. Applied Parts to line/neutral <1.0 mA @ 3535 Vdc ______________

Perform an operational check using the Patient Simulator and the Patient Interface. Please see the NIM® 3.0 and Patient Simulator User Guides for details.

_______( )

Nerve Integrity Monitor

Appendix C Patient Simulator

Instructions for Use

Introduction

Important Notice: This Patient Simulator Guide covers the NIM-Neuro® 3.0 , and NIM-Respon se® 3.0.

System description

e Medtronic Xomed NIM® 3.0 Universal Patient Simulator provides for testing some of the features of the NIM® 3.0 system without the need for patient interaction. In addition, the NIM® 3.0 Universal Patient Simulator is a convenient means of testing various aspects of instrument operability prior to patient application. is section describes the NIM® 3.0 Patient Simulator and pertinent components of the NIM® 3.0 system used during a test.

On the NIM® 3.0 Universal Patient Simulator, there are 8 channel stimulation contact pads, one (1) for each channel. ese contacts are the points for activating individual circuits. A monopolar probe is recommended for use during testing.

System Set-Up

Simulator Set-Up

Simulator use requires prior setup of the NIM® 3.0 unit as previously described.

A. Positive electrode jacks. B. Negative electrode jacks. C. Stimulator STIM1 jack. D. Incrementing Probe control jack. E. Stimulus return jack. F. Electrode ground. G. Auxiliary stimulator STIM2 or APS™ jack.

Note: APS™ Stimulating Electrode cannot be used w ith the Simulator.

H. Simulated positive electrodes for connection to the Patient Interface. I. Simulated negative electrodes for connection to the Patient Interface. J. Simulated electrode ground plug for connection to the Patient

Interface.

K. Simulated stimulus return plug for connection to the Patient

Interface.

L. Simulated patient with inserted electrodes (pads).

M. Probe for stimulating patient electrode pads (Simulated Events). N. Stimulus plugs for connection to the Patient Interface. O. Incrementing probe control plug for connection to the Patient

Interface.

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

Follow these steps to set-up the system for Simulator use:

1. Connect all channel jumper cables (simulated subdermal electrodes, ground, and STIM1 return (STIM1 return can also be used as the STIM2 return)) from the simulator to the corresponding patient interface. See Wiring Table.

2. Connect a monopolar stimulator to the STIM1 negative (black) jack on the patient interface.

Wiring Table

Patient Simulator to Patient

Interface

NIM-

Response®

3.0

NIM-

Neuro®

3.0

Connector Wire Ch. #Connects ToYes No Yes No

Blue Blue 1 Positive x x Blue Black 1 Negative x x Red Red 2 Positive x x Red Black 2 Negative x x Purple Purple 3 Positive x x Purple Black 3 Negative x x Orange Orange 4 Positive x x Orange Black 4 Negative x x Gray Gray 5 Positive x x Gray Black 5 Negative x x Yellow Yellow 6 Positive x x Yellow Black 6 Negative x x Brown Brown 7 Positive x x Brown Black 7 Negative x x Tan Tan 8 Positive x x Tan Black 8 Negative x x Red White N/A STIM1 / 2 x x Green Green N/A Ground x x

Nerve Integrity Monitor

System Assessment

Conrming Electrodes

is check conrms that all electrode circuits are connected and functioning properly.

3. Connect simulators and probe to patient interface and patient interface to the NIM® 3.0.

4. Turn on the “Power Switch”.

• e NIM® 3.0 will perform a series of self test during the “Boot

Up” process. (is process takes about 40 seconds).

5. Aer the Splash Screen closes the “Set‑Up” screen will open.

Electrode Lead O

is test simulates what happens when contact with an electrode is lost.

1. Starting at the Monitoring Screen (all adjustments are at default values): a. Disconnect the positive lead from Channel 1. b. Aer Removal:

• Channel 1 shows a background noise waveform.

• ere is a continuous noise. is is due to ambient electronic noise being picked up by the disconnected electrode.

c. Aer approximately 30 seconds, (but within 70 seconds), the

alarm stops and “Electrode O” is displayed in Yellow Text on a zero (0) amplitude waveform line.

2. Reconnect the electrode and conrm the NIM® 3.0 returned to normal operation.

3. Repeat test for all channels.

Note: If any of these conditions are different check your set-up, if still incorrect contact Customer Care.

Any procedure may be used. For this procedure we will assume that the operator has setup a Custom Procedure (see System Set‑Up/ Custom Set‑Up for instructions) called “Stimulator Test” and named the channels Ch1 Ch2 etc. (4 channels for NIM‑Response® 3.0 and 8 channels for the Neuro shown).

6. Select Custom Procedure/Simulation Test.

7. e next screen to open will be Set‑Up Step 2 of 3.

8. If the Electrode Check Panel is closed press the Electrode Check Tab if open proceed to step 9.

9. Press the Show Details button.

Stimulation

Mechanical Stimulation

e positive and negative patient stimulator electrode cables are sensitive to touch (mechanical stimulation) and will generate EMG visual tone responses when manipulated (tapped). ese simulated responses appear as spontaneous burst‑like responses.

1. Start at the Monitoring screen with default settings, with all electrodes connected.

Note: Detect Artifacts check box (Advanced Settings button/ Monitoring tab) should by default be selec ted (On), if not tur n it On (select).

2. Lightly tap the electrode connectors.

3. Observe:

• You should hear single beep as each channel is tapped.

• Alarm tones are lowest for channel 1 and highest for channel 8.

• You should see sharp (spike like) waveforms on the screen.

• “Detected Artifact” will appear as a orange trace.

• Tapping multiple cables will produce multiple alarms and

waveforms.

Un‑Stimulated

(mechanical) Event

Stimulus: Set and Measure

Stimulated (patient

simulator) Event

Stimulated Event

10. Electrodes screen opens. At this display conrm:

• All channels are on.

• All channels have Subdermal selected.

• Positive and negative kΩ (impedance) of all 8 or 4 channels is

5.1kΩ or 5.6kΩ ±1.0kΩ.

• e Δ (dierence) in their values is 500Ω ± 500Ω.

• e kΩ (impedance) of the Ground is 6.5kΩ ± 1.0kΩ.

• e kΩ (impedance) of the Stimulus Return is 6.2 kΩ ± 1.0kΩ.

• Warning “Monitoring is Disabled” is on and ashing.

Note: If any of these conditions are different check your set-up, if still incorrect contact Customer Care.

1. Start at the Monitor screen (default settings) with all electrodes connected using a monopolar probe with universal handle or incrementing probe handle, with Prass tip.

2. Check stimulus adjustment buttons. a. e upper le of the screen should read 0.8 (this is the mA

setting).

b. Below the mA setting is a small window reading 0.00mA. is is

the measured value.

c. Press the Minus and Plus buttons observing that the mA setting

changes values.

d. Press the mA + button until reaching a value of 3.00mA.

• A dialog box will open: Stimulus in excess of 3 mA

Press OK to allow stimulus

3. Touch and hold the stimulating probe to channel1 of the Patient Simulator and Observe:

Nerve Integrity Monitor

• Stimulus waveform on channel1 (see Example Stimulus and Spike Waveforms).

• Stimulus tone sounds (steady repeating beep).

• Raw EMG can be heard (a popping sound accompanying the stimulus tone).

• mA Measured is ± 5% of the mA setting.

• e μV reading is displayed to the right and above the zero (0) amplitude line in yellow and boxed.

4. Repeat test for all channels.

5. Set mA button to 1.00mA and Event reshold to 100μV.

6. Stimulate channel 1 and observe that stimulus tone sounds (repeating beep) and raw EMG can be heard (a popping sound accompanying the stimulus tone).

7. Increase the Event reshold to 500μV and stimulate channel 1and observe:

• Stimulus waveform on channel1.

• Stimulus tone is NOT heard.

• Raw EMG can be heard (a popping sound).

• mA Measured is ± 5% of the mA setting.

• e μV reading is displayed to the right and above the zero(0)

amplitude line, the highest in a yellow box.

8. Repeat for remaining channels.

9. Move the Stimulator and STIM1 Return to STIM2 and repeat steps 2, 3, and 7 using any channel.

Cleaning

See Cleaning and Maintenance.

Storage

Allow the unit and accessories to thoroughly air‑dry before storing in a cool dry place. See Technical Specications for further information.

Troubleshooting

Should you encounter any diculty eliciting simulated responses from the NIM‑Neuro® 3.0 System Patient Simulator, check the following:

• Verify that Stimulus Measured is approximately the same as Stimulus Intensity.

• Make sure the jumper cables are connected correspondingly between the SIMULATOR and PATIENT INTERFACE.

• Adjust the EVENT THRESHOLD setting on the NIM‑Neuro®

3.0 System.

• Adjust the STIMULUS intensity on the NIM‑Neuro® 3.0 System for adequate output.

• Clean the stimulator contacts of debris.

• Check the integrity of the stimulator or stimulus‑dissection instrument and its connecting cable.

• Check for blown fuse in NIM‑Neuro® 3.0 System Patient Interface and replace with proper valued fuse (shown near fuse box).

• Check for proper closure of fuse holder in the NIM‑Neuro® 3.0 System Patient Interface.

10. If a Remote (Incrementing Probe) is available check the stimulus adjustment as shown in the B 2, B3 and B4 illustration. (If all 8 channels have been tested it is acceptable to test the remote probe on any one channel).

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

Note: If any of these conditions are different check your set-up, if still incorrect contact Customer Care.

Threshold Test

1. Decrease Event reshold to 20μV.

2. Press the channel 1 electrode wire with nger. At this point, the monitor will be picking up electronic noise higher than the threshold setting causing multiple event tones to sound.

3. Turn On (select) Auto reshold Check Box.

4. Press the channel 1 electrode wire with nger and observe:

• continuous event alarms sounding for 10 seconds

• aer 10 seconds, reshold Increase is announced

• event tones no longer sound

• the new threshold value is displayed next to the channel number.

Note: Auto Thresholds maximum i s 400μV. Holding a channel electrode wire between thumb and forefinger or pressing the wire to hard can generate signals greater than the maximum. In this case the threshold w ill increase to 400μV but alarms will continue to sound.

5. Repeat for remaining channels.

Note: If any of these condition are different check your set-up, if still incorrect contact Customer Care.

Nerve Integrity Monitor

Appendix D e NIM® 3.0 Equipment Cart

e equipment cart serves as a convenient means to operate the NIM® 3.0 in the operating room as well as store the console, and accessories when not in use.

Uncrating

2 3

6 7

(2x)

NIM® 3.0 Tether

e Equipment Cart is supplied with a tether that needs to be installed.

1. Remove parts from bag and using a phillips screwdriver attach tether to the bottom of the NIM® 3.0. See illustration 1.

2. Open the rear door and pull the top drawer out about half way then insert the tether through the hole in the top of the NIM® 3.0. See illustration 2.

3. Reaching in through the rear door locate the stud in the top plate and secure the tether to the stud using the knurled nut. See illustration 3.

Nerve Integrity Monitor

Nerve) 2 Ch

Ankle (Tibial

2 Ch

Knee

(Peroneal)

Paired

Abductor

Prass Paired

Hallucis Prass

Abductor Digiti

Type

Available to surgeon no

default names or Electrode

Nerve) 2 Ch

Ankle (Tibial

2 Ch

Knee

(Peroneal)

Prass Paired

Abductor Digiti

Prass Paired

Abductor Hallucis

Paired

names or Electrode Type

Available to surgeon no default

Electrode Type

4 Ch

Lower Extremity

Neck Dissection

(2Ch)

Parotid

NIM-Response® 3.0

yroid

with APS™

Peroneus Longus Prass Paired

Vocalis Le

Endotracheal Tube

Subdermal

Orbicularis Oculi

Vocalis Le

Endotracheal Tube

Paired,

Tibialis Ant. Prass Paired

Vocalis Right

Endotracheal Tube

Subdermal

Orbicularis Oris

Vocalis Right

Endotracheal Tube

Abductor

Prass Paired,

Abductor Digiti

Sternocleidomastoid

Available

Mentalis

Hallucis Prass

Trapezius

Subdermal

Type

names or

Electrode

no default

to surgeon

Frontalis

Subdermal

Electrode Type

no default names or

Available to surgeon

Yes

4 Ch

Lower

Extremity

Neck

Dissection

(2Ch)

Parotid

with

APS™

yroid

NIM-Neuro® 3.0

Tibialis Ant. Prass

Peroneus Longus Prass

Tube

Vocalis Le

Endotracheal

Vocalis Right

Subdermal

Orbicularis Oculi

Vocalis Le

Endotracheal Tube

Abductor

Digiti Prass

Tube

Endotracheal

Orbicularis Oris Subdermal

Vocalis Right

mastoid

Sternocleido‑

Mentalis

Subdermal

Endotracheal Tube

Mentalis

Subdermal

Paired,

Subdermal

Prass

Hallucis

Abductor

Trapezius

Subdermal

Available

Frontalis

Subdermal

Frontalis

Subdermal

Paired,

no default

to surgeon

Available to

surgeon no default

Vocalis Le

Available to surgeon no default names or

Available

to surgeon

Subdermal

Hypoglossal

Type

names or

Electrode

surgeon no

Available to

default names

Type

names or Electrode

Tube

Endotracheal

Vocalis Right

Type

names or

Electrode

no default

Type

or Electrode

Tube

Glosso‑

Subdermal

pharyngeal

Yes

Mastoid yroid

Implant

Cochlear

2 Ch

Acoustic

Appendix E Default Tables

Channel Default Settings

Nerve Integrity Monitor

Neuro / Otology Head/Neck Peripheral

Neuroma

4 Ch

Neuroma

Name,

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

Specifications and Main Features

Frequently Asked Questions

User Manual