Medtronic 8253600 Instructions for Use

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Nerve Integrity Monitor

NIM-Response® 3.0 and NIM-Neuro® 3.0

1. Select Procedure

Neuro/Otology

Custom Procedures

* indicates default settings have been changed

Monitoring

Setup

Monitoring

Setup

Step 1 of 2

Head/Neck

Peripheral

5/1/2009 9:00 AM

NIM-Response 3.0

Information

Reports

NIM-Response® 3.0

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

NIM-Response 3.0

Global

Settings

Help

1. Select Procedure

Setup

Step 1 of 2

Neuro/Otology

Head/Neck

Peripheral

Custom Procedures

Monitoring

Information

Reports

NIM-Neuro® 3.0

User’s Guide

* indicates default settings have been changed

5/1/2009 9:00 AM

NIM-Neuro 3.0

Global

Settings

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

Help

NIM-Neuro 3.0 and NIM-Response 3.0

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: NIM-Response® 3.0, NIM-Neuro® 3.0, and APS®. All other trademarks, service marks, registered trademarks, or registered service marks are the property of their respective owners in the United States and other countries.

Symbols

LOT

ACC

REF

STERILE R

STERILE

STERILE EO

EC REP

0123

IPX1

IPX7

IPX8

NIM-Neuro 3.0 and NIM-Response 3.0

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

Manufacturer

Date Of Manufacture

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

Conforms To IEC/EN60601-1 and ANSI/AAMI ES60601-1 Certied To CSA C22.2 No.60601-1

105345

Protective Earth

Equipotential

Consult Instructions for Use

Caution

Protected Against Vertical Water Drops.

Catalog Number

AC Power

Output

Input

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

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.

Follow instructions for use.

General warning sign

Quantity

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

Printer

NIM-Neuro 3.0 and NIM-Response 3.0

Contents

Symbols ........................................................................................................... 3

Buttons and Indicators .............................................................................. 5

Glossary (used in this manual) ................................................................. 6

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

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

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

Warnings and Precautions ........................................................................7

Warnings ...................................................................................................................7

Precautions ..............................................................................................................8

NIM Quick Monitoring Setup ................................................................... 8

Basics of What You Will See and Hear During Monitoring ............. 9

When the System Arrives...........................................................................10

Unpacking and Inspection ...........................................................................10

Software..............................................................................................................10

Components ..................................................................................................10

Console Front ..........................................................................................................10

Console Left side ....................................................................................................10

Console Rear ............................................................................................................10

Patient Interface .....................................................................................................11

Patient Simulator ...................................................................................................11

Stimulator Probes/Handles ................................................................................11

Monopolar .........................................................................................................11

Bipolar .................................................................................................................12

Muting Detector .....................................................................................................12

APS Electrode Handswitch .................................................................................12

Electrodes .................................................................................................................13

Power Cords .............................................................................................................13

The Splash Screen ..................................................................................................14

Self Test ...............................................................................................................14

Setup Mode .................................................................................................... 14

Select Procedure Step 1 of 2 Screen .........................................................14

Global Settings .......................................................................................................15

Add/Maintain Custom Titles and Comments on the Global

Settings Screen ................................................................................................15

Quick Tags ..........................................................................................................16

Help ..............................................................................................................................16

View Electrode Placement Using the Help Screen ..............................16

Electrode Placement ......................................................................................17

Listen to Audio Samples ...............................................................................18

Place Electrodes Step 2 of 2 Screen .................................................................18

Electrode Check ......................................................................................................18

Electrode Check Panel ...................................................................................18

Electrode check Panel Pass/Fail ..................................................................18

Electrode Check Show Details Panel ........................................................20

Electrode Type Panel ......................................................................................20

Case Information ....................................................................................................20

Procedure Settings Panel ....................................................................................21

Advanced Settings ................................................................................................22

Audio Tab ...........................................................................................................22

Monitoring Tab .................................................................................................23

Identify STIM1 and STIM2 Names ..............................................................24

Stimulus Artifact Example ............................................................................ 24

Special Note on Recognizing Artifact ...................................................... 25

Important Note on Stimulator Adjustments .........................................25

Microscope Tab (available on the NIM-Neuro 3.0 only) ....................26

APS Tab ................................................................................................................27

Monitoring Mode ......................................................................................... 28

Events Panel .............................................................................................................29

Control Panel ...........................................................................................................29

The APS Monitoring Screen ...............................................................................30

Mute an APS Alarm .........................................................................................31

The Reports Mode ........................................................................................ 32

Select Report Format ............................................................................................32

Snapshots/Event Reports .............................................................................32

Choose Report Content .......................................................................................33

Generate Snapshots/Events Report Format.................................................33

Snapshots/Events Reports .pdf Image Example .................................34

Select the Log File ..................................................................................................34

Construct the Log File ..........................................................................................34

Generate the Log File ...........................................................................................35

Log Reports pdf Image Example ............................................................... 35

Log Reports .csv (in Excel) Example ..........................................................35

APS Reports .............................................................................................................33

APS Reports .pdf Image Example .............................................................. 36

Creating a Report ...................................................................................................36

Snapshots Report ............................................................................................ 36

Log Files .....................................................................................................................37

Quick Reports .......................................................................................................... 37

Special Functions and Features ...............................................................37

Visual Alarms and Warnings ...............................................................................37

Audio – Understanding What You Hear .........................................................38

Alarms ..................................................................................................................38

Voices ...................................................................................................................38

Tones ...................................................................................................................39

STIM Bur Guard ................................................................................................39

System Set-Up ............................................................................................... 39

Operating Room Set-Up ......................................................................................39

Typical Set-Up (shown with IPC) ................................................................39

Anesthesia Requirements ............................................................................39

Muting Detector Set-Up ......................................................................................40

Muting .................................................................................................................41

Monopolar Electrosurgical Instrument Clamping ...............................41

Patient Interface Set-Up .............................................................................41

Patient Interface and Stimulators ...................................................................41

Monopolar Incrementing Probe ................................................................42

Monopolar Probe with Universal Handle ...............................................42

Bipolar Probe ....................................................................................................43

APS Electrode Stimulator .............................................................................43

Patient Interface and Stimulator Combinations .........................................43

Monopolar Incrementing Stimulator and APS

Electrode Stimulator ......................................................................................44

Monopolar Probe and Stimulus Dissection Probe ..............................44

Bipolar and Monopolar Probe ...................................................................44

Monitor Set-Up ..............................................................................................45

Basic Set-Up All Procedures ...............................................................................45

Standard Set-Up .....................................................................................................45

Custom Set-Up ........................................................................................................45

Additional Settings................................................................................................46

For Installing the Stimulating Electrode .................................................46

APS Monitoring ......................................................................................................46

Changing APS Settings .................................................................................47

Surgery Notes ...................................................................................................47

After Surgery ...........................................................................................................47

When the Case is Complete ...............................................................................47

When Monitoring is Complete ..........................................................................47

Power Disconnection .....................................................................................47

Cleaning and Maintenance .......................................................................47

Cleaning (after each use) .............................................................................47

Storage ................................................................................................................47

Maintenance .....................................................................................................47

Maintenance Schedule ..................................................................................48

Fuses ...........................................................................................................................49

Console Replacement ....................................................................................49

Patient Interface Replacement ...................................................................50

Troubleshooting ...........................................................................................51

Technical Specications ........................................................................... 52

Accessories / Parts List ................................................................................ 55

System Components & Accessories ..........................................................55

Annual System Quick Check ..............................................................................56

Patient Simulator Instructions for Use .................................................. 57

Introduction .............................................................................................................57

System Description ...............................................................................................57

System Set-Up .........................................................................................................57

Simulator Set-Up .............................................................................................57

System Assessment ...............................................................................................58

Conrming Electrodes ...................................................................................58

Electrode Lead O ..........................................................................................59

Stimulation ...............................................................................................................60

Mechanical Stimulation ................................................................................60

Stimulus: Set and Measure ...........................................................................60

Threshold Test ..................................................................................................61

Cleaning ..............................................................................................................61

Storage ................................................................................................................60

Troubleshooting .............................................................................................60

The NIM 3.0 Equipment Cart .................................................................... 62

Uncrating ..................................................................................................................62

NIM 3.0 Tether .........................................................................................................62

Channel Default Settings...........................................................................63

Display Default Settings.............................................................................64

STIM1 & 2 Default Settings ...................................................................... 64

Microscope Default Settings .................................................................... 64

Guidance and Manufacturer’s Declaration –

Electromagnetic Immunity ....................................................................... 65

Part I ............................................................................................................................65

Part II ...........................................................................................................................66

Limited Warranty .......................................................................................... 67

NIM-Neuro 3.0 and NIM-Response 3.0

Ω

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.

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

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.

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)

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

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

Setup Button: Opens/Starts the setup process

Monitoring Button: Opens the Main/Monitoring Screen

Reports Button: Opens the Reports Screen

Program Loading Indicator

NIM-Neuro 3.0 and NIM-Response 3.0

Glossary

APS Automatic Periodic Stimulation.

DSP Digital Signal Processor.

Event Sequence A series of events separated from each other by less than one second.

FCU Foot Control Unit.

GUI Graphical User Interface.

NIM Nerve Integrity Monitor.

NIM 3.0 NIM-Neuro 3.0 or the NIM-Response 3.0

Stimulus Artifact A monitoring term for an artifact created by stimulus voltage delivered to the patient, which is

picked up as feedback either internally or externally to the monitoring equipment. It is normally small and does not impact monitoring but can, under certain conditions, be displayed and sounded on the monitor.

Stimulus Artifact On-Screen On the monitoring screen, the stimulus artifact appears as an event (above or below threshold)

which starts directly after the stimulus on the left side of the screen and proceeds for a duration into the EMG waveform detection area. The level of the artifact is directly proportional to the stimulus delivery and cannot be EMG because nerve signals need time propagate.

Stimulus Artifact Sound The audio representation of a stimulus artifact. It is a high frequency sound similar to a cymbal (ti--

tchi). This sound should not be confused with an EMG sound which sounds like a drum beat.

Stimulus Rejection Period

Adjustable delay reading EMG after stimulation. In previous versions of the NIM, this was referred to as Stimulus Artifact or Artifact Delay.

NIM-Neuro 3.0 and NIM-Response 3.0

Indications for Use

The 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. The 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, Thoracic 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 Thoracic Surgical Procedures.

Device Description

The NIM-Neuro 3.0 is an eight-channel and 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. The NIM 3.0 System records electromyographic (EMG) activity from muscles innervated by the aected nerve. The 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. The monitor utilizes touch screen and color graphic user interface (GUI) along with the audio feedback to increase the usability of the device.

Contraindications

The 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.

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

W1 The 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.

W2 If paralyzing anesthetic agents have been used, patient must regain muscle activity prior to use of the NIM-Neuro/Response 3.0 EMG

Monitor. a. To limit the paralytic eect of anesthetic agents, the anesthesiologist should monitor Train-of-Four (TOF) to prevent diminished EMG activity. Consult anesthesiologist if EMG changes are observed.

W3 Surgical Identication of exposed Neural structures is key to their preservation. Failure to use Nerve Stimulation Probe may contribute to

unintended surgical nerve damage or resection.

W4 To avoid the risk of re or explosion, do not use the Medtronic NIM System in the presence of ammable anesthetics and/or oxygen rich

environment. W5 After each procedure, properly clean and disinfect all reusable system components. W6 To avoid alternate site patient burns or lesions:

a. Do not activate the electrosurgical instruments (ESU) while stimulator is in contact with tissue.

b. Do not leave dissection instruments, stimulating electrodes, or probes in surgical eld.

c. Do not store dissection instruments, stimulating electrodes, or probes in electrosurgical instrument holder.

d. Do not allow a second surgeon (for example, fat harvesting) to use electrosurgical instruments while stimulator is in use.

e. Do not activate electrosurgical instrument for prolonged periods while ESU is not in contact with tissue.

f. Do not activate electrosurgical instrument near the recording or stimulating electrodes.

g. Do not allow patient interface boxes or recording / stimulating electrodes sites to be ooded with saline.

h. Do not allow excessive stray AC or DC leakage currents from patient connected equipment; Avoid creating an unintended grounding

path through applied electrodes. Practitioner is responsible for proper use, periodic safety certication of patient connected equipment, and AC power grounding in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 medical safety standard.

W7 Disconnect power to the console before cleaning the unit to avoid electrical macro shock. W8 Achieve electrical grounding reliability with proper connections. Connect the console to hospital grade receptacles only. W9 DO NOT use any parts other than Medtronic Xomed, Inc. components as damage or substandard performance could result. W10 This 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. W11 It is important that the NIM-Neuro/Response 3.0 operator be familiar with this manual, its precautions, procedures and safety issues. W12 To avoid electrical shock, do not attach unapproved components or accessories to the Medtronic NIM System. W13 All service must be performed by Medtronic qualied personnel only. W14 Do not directly contact active, implanted devices with the stimulator as it may disrupt the implanted device’s operation. Consult medical

specialist before use. W15 Electrocardiogram monitoring artifacts may be caused by Medtronic NIM stimulus current delivery or EMG electrode impedance

monitoring.

NIM-Neuro 3.0 and NIM-Response 3.0

W16 Use of unapproved stimulators, stimulus probes, stimulus dissection instruments or electrodes may result in compromised Medtronic NIM

operation, such as, but not limited to decreased accuracy. W17 Repair and/or modication to the Medtronic NIM or any accessory by 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. W18 To avoid the risk of infection, the user must maintain good sterility practices. W19 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 and not detected (32mA, 250V. Xomed Part No.: 8253075).

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. Simultaneous stimulation of the nerve and the surrounding tissue, resulting in current shunting (inadequate delivery of stimulus

current to target nerve tissue). g. Flatline on the EMG channel caused by shorted internal amplier (characterized by baseline activity of < 3μV peak-to-peak). h. EMG electrodes not positioned properly in the target muscles.

W20 Stimulator current may cause involuntary patient movement resulting in patient injury. W21 If the incrementing probe handle malfunctions, it could result in increased current delivery to the patient. Immediately disconnect the

Control Plug from the Patient Interface box and use the console to adjust stimulus current.

W22 Be careful not to damage vascular or neural structures when preparing the nerve for the installation of the APS Electrode. W23 Electrode integrity should be checked after electrode insertion and before electrode removal to give additional assurance that electrode

continuity was maintained throughout the entire procedure. If the system indicates improper electrode impedance, consult the Troubleshooting topic for impedance value troubleshooting.

W24 Remove APS electrode from patient prior to using external debrillator to prevent thermal injury to patient at APS electrode site. W25 Operation in close proximity to high frequency (shortwave or microwave) equipment may produce instability in the electrical stimulator

output.

W26 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 (Neurophysiologist) attention is required for stimulus levels which exceed default settings or conditions. Levels higher than 2mA RMS/ cm2 (3 mA) for Slim Prass Probe and Prass Bipolar Probe may result in tissue damage.

W27 Do not perform Magnetic Resonance Imaging (MRI) on a patient with electrodes, probes, and EMG tubes in the eld. The eect of MRI is

unknown on these devices.

W28 Loud extraneous monitoring noise may be caused by activation of electrosurgical unit. Muting Detector must be properly attached to the

active electrosurgical lead.

Precautions

P1 Medical Electrical Equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put

into service according to the EMC information provided in this Guide.

P2 Portable and mobile RF including cell phones and 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 The 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 Inability to deliver stimulus current ow may be caused by inadvertent simultaneous current delivery from both STIMprobe outputs,

resulting in current shunting.

P6 Avoid accidental contact between ‘PATIENT APPLIED PARTS’ and other conductive parts including those connected to protective earth. P7 The metal 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.

P8 The muting detector is susceptible to damage from dropping. Visually inspect inner jaw surfaces for cracking, chipping or damage prior

to use. Insucient muting may result.

NIM Quick Monitoring Set-Up

The following procedure for OR sta users is not meant to replace a complete understanding of this user’s guide, but may serve as a quick reminder of basic NIM setup, monitoring screens, and monitoring sounds. Refer to the Monitoring set-up topic for more information.

1. Place the NIM 3.0 system within the surgeon’s view and plug the NIM power cord into the dedicated outlet.

2. Turn the NIM system on. The self-test is complete.

Note: Do not use long-term paralyzing anesthetics to ensure proper EMG monitoring.

3. On the NIM SET-UP screen, select a specic surgery to be monitored. The Place Electrodes illustration appears indicating how to make the connections.

4. Synchronize the NIM date and time to the OR clock, enter the patient information, and surgeon name.

5. Following the illustration on the screen, connect all color coded cables (subdermal electrodes or EMG tube, ground, and STIM 1 return) to the corresponding patient interface.

NIM-Neuro 3.0 and NIM-Response 3.0

6. Connect a monopolar stimulator probe to the STIM 1 jack. Note: Once the electrodes are connected, the Automatic Electrode Check: GREEN Checks conrms the integrity of the connections.

7. Clip the muting detector to the monopolar electrocautery cord(s) and plug it into the MUTE input located on the back of the NIM console.

8. Begin monitoring by proceeding to the Monitoring panel by pressing Monitor. Your NIM 3.0 system is ready to monitor with its default settings.

Basics of What You Will See and Hear During Monitoring

The following procedure is meant to be completed by surgeons and OR sta users. Refer to the Monitoring Mode topic for more information.

1. The surgeon stimulates the nerve with a probe to conrm the location and integrity of the nerves.

Upon stimulation of the nerve, EMG is evoked and is audible in the form of event tones and raw EMG sounds pulsed at ~4X/sec. The EMG event is also shown on the monitoring screen as a waveform. See gure 1.

Figure 1. Biphasic EMG waveform

• Peak-to-peak measurement or amplitude.

• Note the latency is measured from the stimulus from the left hand side of the screen to the start of the EMG waveform.

2. The surgeon uses the stimulator probe as the primary means to conrm the location and integrity of the nerves.

The NIM is continuously monitoring and you may also hear changes in the EMG, or mechanically evoked nerve responses that look and sound similar to stimulator evoked nerve responses.

Note: It is important to understand the NIM system’s visual and audio feedback so as not to confuse the stimulus artifact with real EMG, or recognize if both the stimulus artifact and real EMG are present at the same time.

The NIM system sounds a “Current Delivery” tone (a short warble sound) when contacting tissue, but not evoking a response. The tone indicates the set current is being delivered.

3. The surgeon conrms the integrity of the nerve using the probe throughout the entire procedure including at the end.

4. If desired, document the pre- and post-surgical EMG monitoring responses with the Reports or Save features on the NIM.

Refer to the table of contents for more information on the following related topics:

• Stimulus artifact

• Threshold

• Undertanding audio/visual

NIM-Neuro 3.0 and NIM-Response 3.0

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.

After unpacking, save the cartons and packing material. If the instrument is to be shipped the shipping package will provide proper protection.

Software

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

Components

Console Front

1 - STIM1 stimulus adjustment. 2 - STIM2 stimulus adjustment. 3 - Touchscreen. The Touch Screen displays EMG waveforms and controls many of the functions of the

NIM 3.0. 4 - Volume adjustment. 5 - Product name. 6 - The Speaker provides audio alarms, acoustic EMG monitoring, and voice prompts.

Console Left side

1 - Anti-Glare Stand. Use this device to change the viewing angle of the NIM 3.0 screen. It is shown in

the tilted (up) position.

2 - USB Out. The USB Out is an industry standard USB type connector that you can use with mass

storage devices.

Console Rear

1 - Carry Handle for transporting unit. 2 - Potential equalization terminal. Can be used to equalize ground potentials between O.R.

instruments.

3 - Accessory Power Outlet. Use this power outlet with the NIM 3.0 printer power device only. 4 - Fuse Access. The AC power fuses are located on the back of the units. 5 - Power Switch. The power switch turns power on or o. 6 - Power Connector. The power cord plugs into the back of the NIM 3.0 System console. The input

fuses and accessory output is in the power entry module. Plug the power cord into the A/C power outlet.

7 - Anti-Glare Stand. Use this device to change the viewing angle of the NIM 3.0 screen. It is shown

in the tilted up position.

8 - Patient Interface Connector. The patient interface connector is a 44-pin D-sub.

9 - RCA Audio Jack. An RCA audio jack is provided to output an audio signal that you can overlay

onto a video signal when using industry standard recording devices. The output is audio line

level (1 Vp-p). 10 - Handswitch connector. Used for APS procedures only. 11 - Muting Detector Input. Near-eld radio frequency detector. 12 - Mini Jack. Standard conguration used for private listening through Stereo Headphones. 13 - For future use. 14 - Surgeon Mini Screen Port. Output connection to Surgeon Mini Screen or video recorder. 15 - USB Out. The USB Out is an industry standard USB type connector (two port) that you can use

with mass storage devices/printer/keyboard. 16 - VGA Output. Only used to connect NIM-Neuro 3.0 System to microscope.

Note: Microscope VGA output not active on NIM-Response 3.0 System.

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.

2 3 4

5 6

10 11

12 13

14 15

Patient Interface

1 - Electrode ground. Signal return for patient electrodes.

2 - Stimulating Instrument Jack or Stimulator Probes (Monopolar or Bipolar).

3 - Incrementing Probe Control Jack. Connects Incrementing Probe controls

to the NIM 3.0.

4 - Stimulus (out) Jack, negative (-).

5 - Stimulus Return, positive (+).

6 - Patient Interface to console connector.

7 - Connector release.

8 - The Patient Interface fuses are for Stimulator Output and specically

tested for ECU protection.

9 - Positive Electrode Jacks. Positive electrodes have matching color-coded

wires and plugs.

10 - Negative Electrode Jacks. Negative electrodes have black wires and

color-coded plugs.

11 - Patient Interface Clips.

12 - NIM-Response 3.0 Patient Interface shown for reference only.

Note: Use Xomed 11270048 Fuse, 5 x20mm, 32mA, 250 V. Order 8253075 Fuse Kit for replacements.

NIM-Neuro 3.0 and NIM-Response 3.0

1 2 3

4 5

9 10 11

Patient Simulator

Use the Patient Simulator for troubleshooting and demonstrating the system without the need for patient interaction. 1 - Stimulator pads (Simulated Events).

2 - Stimulator return (anode) plug.

3 - Electrode ground plug.

4 - Simulated subdermal electrode plugs.

Stimulator Probes/Handles

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

Monopolar

Ball Tip Probe

1 - Stimulus to Patient Contact Area

2 - Insulated Sleeve

3 - Probe Base

Standard Prass Flush Tip Probe

1 - Stimulus to Patient Contact Area

2 - Insulated Sleeve

3 - Probe Base

Incrementing Monopolar Probe Handle

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

1 - Toggle Button

2 - Probe Jack

3 - Stimulus Plug

4 - Toggle Button Control Plug

1 2

NIM-Neuro 3.0 and NIM-Response 3.0

Incrementing Probe Stimulus Adjustments

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

2 3 1

1 - Toggle button normal or at rest. 2 - Increase current. 3 - Decrease current.

4 - 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

1 - Handle. 2 - Probe Jack. 3 - Stimulus Plug.

Bipolar

Side-by-Side Stimulating Probe

1 - Cable Connection.

2 - Stainless Steel Tubing.

3 - Stimulus to Patient Contact Area.

4 - Insulating Sleeve.

Prass Flush Tip Stimulating Probe

1 - Cable Connection.

2 - Stainless Steel Tubing.

3 - Stimulus to Patient Contact Area.

4 - Insulating Sleeve.

Muting Detector

Refer to Precaution P8 for more information. The 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.

1 - Anti-slide Ring. 2 - Electronic Noise Detection Area. 3 - Insulating Sleeve. 4 - Cable Connector. 5 - Ferrite.

3 4

APS Electrode Handswitch

The APS electrode handswitch cycles through the APS functions (O, Slow, Fast).

1 - Thumb Switch. 2 - Cable.

Electrodes

Electrode types recommended for use with the NIM 3.0 System

NIM 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). The wires are insulated to within 3 mm of the end and are designed to obtain a more specic response.

Paired Subdermal Electrodes. Non-insulated high performance electrodes with 2.5mm spacing.

Prass Paired Electrodes. The electrodes are insulated to within 5mm of the end with 5mm spacing. Musclespecic single use.

Prass Paired Electrodes Small Hub. The electrodes are insulated to within 5mm of the end with 2.5mm spacing. Muscle-specic single use.

NIM-Neuro 3.0 and NIM-Response 3.0

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).

APS (Automatic Periodic Stimulation) Electrode.

Continuous, real-time monitoring of vagus nerve through low-level stimulation.

Single-use.

Power Cords

1897821 Power Cord, 6 Meter, 115 V 1895820 Power Cord Standard, U.S. 1895822 Power Cord, 6 Meter, Europe, U.K. 1895823 Power Cord, Japan, 100 V

Additional information can be found at www.mcatalogs.com/ent/ .

NIM-Neuro 3.0 and NIM-Response 3.0

Splash Screen

Self Test

The system automatically performs an internal integrity check each time you turn the NIM-Response 3.0 ON. Refer to the Maintenance Schedule topic for more information.

Once the NIM-Response 3.0 powers-up, the system briey diplays a series of messages. Then the console does a series of self-tests on the hardware.

Setup Mode

Select Procedure Step 1 of 2 Screen

The Setup screen is the default screen. You must select an existing procedure or begin a new (custom) procedure from the default screen. Optional: You may enter/change the date, time, language, or data elds via the Global Setting button.

1 Tool bar. Select any of the three major functional modes.

2 3

1. Select one of the following procedures by touching it on the screen.

• Neuro/Otology

• Head/Neck

• Peripheral

• Custom Procedures

The system opens a drop down menu which includes a selection of pre-dened procedures.

2. From the drop down menu, select one of the pre-dened procedures by touching it.

The Place Electrodes screen appears.

3. Place the electrodes according to the diagram.

4. Do one of the following:

• Go directly to monitoring either by pressing the Monitoring selection on the top toolbar, or by pressing Monitor.

2 Setup button (default)

3 Set up wizard navigation bar 4 Select procedure (drop down menus) 5 Print, Save, and keyboard icons. These icons only appear if you

connect a USB drive, keyboard, or printer. 6 Monitoring and report buttons. Not available on start up. 7 Screen print/Screen save button (if USB drive is connected) 8 Information button 9 Global settings button 10 Help button

11 Time and date bar. shows the time and date as set in the Global

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

• Access the summary of electrode impedance by pressing .

NIM-Neuro 3.0 and NIM-Response 3.0

Global Settings

You can access the Global Settings panel by pressing the Global Settings button in any of the Setup Mode screens.

1 Global Settings screen 2 Language tab 3 Date /Time tab. Select how the system displays the

date/time. The default format is language sensitive. 4 Data Fields for Case Information tab 5 Blank data elds. Enables you to name two elds which

will appear on the Case Information screen. 6 Diagnostic Mode. Not for end users. This selection

should only be used under the direct supervision of

Medtronic Xomed personnel. 7 Enable DB Saving check box (default is unchecked).

Turns on the .db option in Reports Mode. 8 Set Date and Time button. Opens a data entry key pad

for setting date and time. 9 Restore Defaults button. Restores all settings, including

procedure settings, to their defaults. 10 OK button closes the Global Settings screen.

Add/Maintain Custom Titles and Comments on the Global Settings Screen

This feature enables you to create new titles/comments or delete entries that have already been created including the default titles. The Edit and Delete buttons appear when you select an existing item in the list. The titles/comments are grouped by procedure type as selected by the radio buttons on the left.

1 Title/Comments tab

2 List box containing procedure names 3 List box containing pre-dened titles for the selected procedure 4 Enable Quick Tags check box

5 New, Edit, and Delete buttons 6 Restore Defaults button 7 Selected item is a Quick Tag title check box

1. Select the Titles/Comments tab on the Global Settings screen.

2. Select a procedure from the list box on the left of the Custom Titles and Comments panel. A list of titles for the selected procedure appears in the list box to the right.

3. Do any of the following:

• Press to create a custom title/procedure. Use the on screen or attached keyboard to type a title or comment.

• Select a title, press , and then edit the existing procedure.

• Select a title, press . The system deletes the title.

4. Press .

The system saves your settings.

NIM-Neuro 3.0 and NIM-Response 3.0

Quick Tags

1 Title/Comment text box. By default, the procedure title you selected on the Titles/

Comments tab appears.

You can use the Enable Quick Tags check box to type an abbreviation of the title that appears on a quick tag button on the tool bar at the bottom of the screen during the Monitoring phase. You can activate a quick tag by selecting a title and then select “Selected item is a Quick Tag title” check box. Once you have selected from the drop down menu, type an abbreviation for the title of the button using the pop-up that appears.

1. Refer to the Add/Maintain Custom Titles and Comments on The Global Settings Screen topic to select a title.

2. Select the Enable Quick Tags check box.

3. Select the Selected item is a Quick Tag title check box.

The Edit Title/Comment Abbreviation pop up appears with the title/comment name in the Title/Comment box.

4. Press the Abbreviation box.

The Abbreviation pop up appears with the choice to use an on screen keyboard, or use your attached keyboard.

2 Abbreviation text box 3 Example of the Quick Tag you created.

5. Type the abbreviation you want to use for your quick tag and press .

The Abbreviation pop up disappears and the system returns you to the Edit Title/Comment Abbreviation pop up with an example of how your quick tag button will appear on the Monitoring screen.

Help

The Help screen displays help graphics for locating electrodes or sample audio sounds.

1 Electrode Placement tab. Selects help graphics for locating

You can use the Help screen to view electrode placement graphics to aid in electrode placement and sample audio sounds.

View Electrode Placement Using the Help Screen

You can use the Electrode Placement tab on the help screen to view electrode placement graphics.

electrodes.

2 Diagram/Nerve radio button. Selects help graphics by nerve

number/name.

3 Diagram/Procedure radio button. Selects help graphics by

Procedure. 4 Graphics display area 5 Previous/Next buttons. Use these buttons to change graphics. 6 Audio Samples tab. Contains three sample sound buttons

(pulse, train, burst). 7 OK button. Closes Help screen.

1. On the Setup screen, press .

The Help screen appears with the Electrode Placement tab showing.

2. On the Diagram panel, select one of the following:

• Nerve – to view electrode placement by nerve number/name.

• Procedure – to view electrode placement by procedure.

NIM-Neuro 3.0 and NIM-Response 3.0

3. Use or to move through available placement help graphics.

4. Place electrodes according to the appropriate help graphic.

5. Press to return to the Setup screen.

Electrode Placement

The surgeon will insert electrodes into the appropriate muscle location innervated by the monitored nerve. Additionally, you need a ground electrode (green) and a stim return (white) to complete the electrode setup. NIM 3.0 systems include nerve and electrode placement guides that are color-coded to help reduce confusion.

This page of electrode placement guides contains some, but not all, possible electrode placements. Refer to the button on the NIM screen for an additional list of electrode placement guides.

Extraocular Cranial Nerve III, IV, VI

-(IV N.)

-(VI N.)

-(III N.)

+(IV N.) Sup. oblique m.

+(VI N.) Lat. rectus m.

+(III N.) Inf. rectus m.

Ground

Stim Return (+)

Facial Cranial Nerve VII - 4 Ch.

Frontalis m.

Orbicularis Oculi m.

Orbicularis Oris m.

Mentalis m.

Ground

Stim Return (+)

Vagus Cranial Nerve X

Right Left

Vocalis 2

Vocalis 1

Trigeminal Cranial Nerve V

Temporalis m.

Masseter m.

Ground

Stim Return (+)

Glossopharyngeal Cranial Nerve IX

Glossopharyngeal m.

Ground

Stim Return (+)

Spinal Accessory Cranial Nerve XI

Facial Cranial Nerve VII - 2 Ch.

Orbicularis Oculi m.

Orbicularis Oris m.

Ground

Stim Return (+)

Hypoglossal Cranial Nerve XII

Hypoglossal m.

Ground

Stim Return (+)

NIM® Standard Tube

™

NIM Contact® Tube

TubeNIM TriVantage

Ground

Stim Return (+)

Sternocleidomastoid m.

Trapezius m.

Ground

Stim Return (+)

NIM-Neuro 3.0 and NIM-Response 3.0

Listen to Audio Samples

You can use the Audio Samples tab on the help screen to hear three types of audio alarms.

1. On the Setup screen, press .

The Help screen appears with the Electrode Placement tab showing.

2. Select the Audio Samples tab.

3. Select any of the following audio samples:

• Pulse

• Train

• Burst

4. Press to return to the Setup screen.

Place Electrodes Step 2 of 2 Screen

The system automatically opens this screen after you select a factory installed procedure.

The Place Electrodes Step 2 of 2 screen assists you with electrode location. When the system runs an electrode check, this screen shows the electrodes the system is testing.

Note: If you make changes to the procedure and want to save them, then you must make the changes before selecting the Monitor or Monitoring button.

Note:

• You can bypass this screen by selecting the Monitor or Monitoring button.

• If you bypass the screen, no pre-surgery impedance values of the electrodes, ground, or STIMreturns are available for printed/saved reports.

• If the patient interface, electrodes, ground, or STIMreturns were disconnected when you opened this screen, any printed report will show a failure of the impedance values of the disconnected item(s).

1 Tool Bar. Allows selection of available functional modes. 2 Monitor button opens the Monitoring screen. Note: If you

make changes in the Electrode Check panel, the Procedure Settings panel, or one of the Procedure Settings/Advanced Settings Tabs, a dialog box opens asking if you wish to save your changes.

3 Previous arrow button. Returns you to the Select Procedure

screen. 4 Setup wizard navigation bar 5 Electrode Placement Graphic. Shows electrode placement

for the patient and patient interface. 6 Information button opens the Case Information screen. 7 Electrode Check tab. Closes/Opens Electrode Check panel. 8 Procedure Settings tab. Opens/Closes Procedure Settings

Panel.

Electrode Check

The Electrode Check screen checks the integrity of the patient to Patient Interface connections. It is the only screen where you can adjust the electrode type in use.

NIM-Neuro 3.0 and NIM-Response 3.0

Electrode Check Panel

You can access this panel from two (2) locations: In Setup Mode with Place Electrodes screen (shown below), or from the Monitoring screen by pressing control panel tab and Electrode Check button.

1 Electrode Check Panel typically appears in Setup Mode with Place

Electrodes Screen. You can open/close the Electrode Check Panel using the Electrode Check tab.

2 The system disables monitoring when the Electrode Check panel

is open.

3 Electrode status eld:

• Progress bar. Appears while the system tests electrodes.

• Question Marks. Question marks appear while the system runs the electrode test and are replaced with pass (green check mark) or fail (red x mark) once the system has completed the test.

4 Closes Electrode Check panel. 5 STIM1, STIM2, and Ground status elds.

Note:

• There is no STIM status (blank) if you select Bipolar on the Type Panel (located in the Advanced Settings/Stimulation Panel).

• There is no STIM2 status (blank) if a single stimulator is connected.

• STIM2 appears after you turn it on using the Activate button located on the main screen, or by selecting the STIM2 or APS™ check box on the Procedure Settings/ Stimulation Panel.

• STIM 1, STIM 2, Ground - If a question mark appears after the system has completed the test, no channel electrode or ground was connected so the system reads that as no value (impedance). You must connect at least one channel electrode and ground for the system to read STIM 1, STIM 2, and Ground impedance.

6 Print or Save button appears in this area. Sends monitoring

electrodes, ground, and STIM 1 and 2 return impedance values to the printer or USB drive.

Note: Print button appears only if a printer is connected. The Save button appears if a USB device is connected.

7 Show Details button. Refer to the Electrode Check Show Details

Panels topic.

Electrode Check Panel Pass/Fail

The system measures impedance values of the electrodes to the patient to conrm the integrity of the connection.

Electrode Check

Warning: EMG Monitoring

is Disabled

Electrode Check

1 - Orbicularis Oculi

2 - Orbicularis Oris

Stim 1 Return

Ground

Ω

Show Details

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

NIM-Neuro 3.0 and NIM-Response 3.0

Hide Details

Electrode Check Show Details Panel

Press the Show Details button to see the actual impedance values. Refer to the “Troubleshooting” topic for more information.

1 Electrode Type Button.

Note: When you select the Details view, the system displays the normal electrode impedance limits if the number of channels is less than six.

Electrode Type Panel

Use the Radio Buttons on the Electrode Type screen to select the type of electrode you want to use. Refer to the “Troubleshooting” topic for information on electrode troubleshooting.

Electrode Check

Warning: EMG Monitoring

is Disabled

Subdermal

1.5kΩ

0.7kΩ

(+) 5.9kΩ (-) 5.9kΩ

(+) 6.0kΩ

(-) 55.8kΩ

Subdermal

Endotracheal Tube

Hookwire

Prass Paired

Surface

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

Case Information

The Enter Case Information screen opens when you press the Information button. Use this screen to enter data into preselected data elds. Refer to the Global Settings topic for data eld selection.

1 Tool Bar. Select any of the three major functional Modes.

2 Setup Wizard Navigation Bar. The Previous and Monitor buttons

are located here. Refer to the Buttons and Indicators topic for more information.

3 Case Information. Press any of the information elds to open the

keyboard for data entry. 4 Procedure Settings Tab. Opens Procedure Settings panel. 5 Global Settings and Help Buttons. Refer to the Global Settings

topic for more information.

1. On the Setup screen, Press .

NIM-Neuro 3.0 and NIM-Response 3.0

The Enter Case Information screen appears.

2. Press the Surgeon box and type the surgeon information using the on screen or attached keyboard.

3. Press .

4. Repeat steps 2 and 3 for the following information:

• Patient ID

• Patient Name

• Patient DOB

• Monitoring Professional

• Notes

5. Press .

The system returns you to the Setup screen.

Procedure Settings Panel

You can only access the Procedure Settings panel through the Setup Mode.

Note: You can save your changes on this panel (save to a new or existing procedure). You can review and/or change the monitoring settings for the procedure.

1. Press the Channels button to access a drop down list of channels.

1 Channels. Add, remove, or change the names of the channels. 2 Stimulation Panel. Adjust STIM1 stimulus and STIM2 or APS stimulus (if selected).

3 Event Threshold Panel. Adjust the event threshold, which has a range from 20μV to 2500μV. 4 Save Button

5 Procedure Settings tab. Opens/closes Procedure Settings panel. 6 Advanced Settings Button

• Opens save option panel.

• Save option panel gives you the option to overwrite the existing procedure, create a new procedure, or cancel.

2. Press an active channel to inactivate that channel. Press an inactive channel to open the Muscle Name keyboard.

3. Use the Scroll buttons to locate an existing muscle group.

4. Highlight the muscle name by touching the screen or type the new muscle name.

5. Press OK

The system saves the muscle name and exits.

NIM-Neuro 3.0 and NIM-Response 3.0

Advanced Settings

Advanced Settings function:

• You can use Advanced Settings adjustments made during the Setup Mode (Procedure Settings Panel) for the current or saved session.

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

When you press the Advanced Settings button, the system opens a screen with tabs that enable access to the functions described.

Audio Tab

Refer to the Audio – Understanding What You Hear topic for more information on the Audio tab.

1 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. 2 Stimulus Delivery Audio panel 3 Monitoring Audio panel 4 Volume Balance panel. You can adjust Sound levels using the + and –

buttons for EMG Audio, Event Tones and Voices. A numeric value and

white bar graph indicate the setting relative to full scale (scale is 1 to 5). 5 OK button. Closes the Advance Settings panel.

Additional options for the Stimulus Delivery Audio panel (2):

• 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: You will not hear the Stimulus Delivery Audio when an event has occurred.

The following options are located on the Monitoring Audio panel (3). At least one selection must be active, however you may select both options.

• 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. The EMG activity may sound like a low-pitched “drumbeat”, a high-pitched “crackle,” or a “growl”. When you monitor multiple channels, 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 Threshold setting. The Event Tones are easily heard over O. R. noise and are heard at the same time with the EMG audio, previously mentioned.

• If you selected “Voice – Stimulated EMG Values” in Advanced Settings/Audio, the NIM announces the value of the highest channel in the last or largest event in a sequence (one second after the sequence ends). The system rounds the actual value appropriately for annunciation. For example, the system would announce 623 as “six hundred twenty.”

You can dierentiate channels by tone pitch. The tone for channel 1 activity is lower in pitch than 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 the tone of the channel with the highest EMG activity will be produced.

You can mute individual EMG channels by selecting Show Channel Mute Buttons.

NIM-Neuro 3.0 and NIM-Response 3.0

Monitoring Tab

1 View Scale. Refer to the Control Panel Display Button. 2 Measurement Cursor Position panel. 3 Waveform Filters panel 4 Event Capture panel 5 Sequence Display panel 6 Latency panel

7 Snapshot panel

8 OK button. Closes the Advanced Settings panel.

In the Measurement Cursor Position panel (2), you can select the following measurement start positions:

• Peak Amplitude - selects the largest peak value

• Latency - places the cursor where the response to a stimulation begins.

There are two types of Waveform Filters (3):

• Artifact Filter: Selecting this Check Box enables the detection of artifact as “Spiked Waveforms” .

• Low Frequency Filter: Low Frequency Response is generally caused by the movement of the electrodes, electrode wires, tissue etc. This 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. The lter is on by default for all procedures.

If you selected the Auto Threshold check box in the Event Capture panel (4) and the Event Tones are continuous for 10 seconds:

• Auto Threshold automatically calculates a new Event Threshold (to a maximum of 400μV).

• You will hear all activity less than the new Event Threshold as raw EMG.

• EMG activity greater than the new Event Threshold or greater than 400μV generates Event Tones.

• Additionally, if you selected the Voice setting, it announces the amount of threshold increase.

• The Event Threshold returns to the original value after 10 – 20 seconds of no, or decreased, event activity.

In the Sequence Display box (5), the Last box is selected by default. The following happens:

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

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

• This remains on screen until replaced with the next event or next largest event from a 4 second series of events.

Note: Neither Event Capture nor Largest are available when the x-axis time scale is set to 20 seconds (it is only available in the 50ms time scale).

On the Latency panel (6), you can do the following:

• Control whether the system shows latency values in non-APS stimulated waveform sweeps using the Display Latency check box.

• Control whether the system measures latency to the onset of the response, or to the highest peak EMG value of the response using the Onset or Peak check boxes.

• If you selected Display Latency in Advanced Settings, then for every stimulation pulse that causes a response greater than 20 µV, the system displays the Latency value on the waveform. It may be measured to the onset of the response or to the highest peak EMG value of the response, depending on the settings you chose.

On the Snapshot panel (7), you can do the following:

• Choose the default snapshot actions using the Comment, Print, and/or Save check boxes. You can select more than one action.

• Select the Probe Saves Snapshot check box to control whether the center position on the incrementing stimulus probe saves a snapshot.

• If the center button is enabled and the Comment button is checked, then when you press the center probe button:

• The title/comment box pops out.

• One of the titles in the list is selected.

• The up/down buttons on the probe now do not change the stim current, but rather move the highlight bar up and down the title list.

• When the desired title is selected, the center button moves the selected item into the Event Title, save/print the snapshot and close the title/comment box.

NIM-Neuro 3.0 and NIM-Response 3.0

1 Name/text eld 2 Type Panel. Use this panel to select either the monopolar or bipolar

3 Pulse Width panel. Use this panel to make adjustments to the

4 Rate panel. Use this panel to make adjustments to the stimulus rate. 5 Current Warning Level. This is the maximum stimulator current setting

6 Rejection Period panel 7 Reject Stim Pulse Artifacts check box 8 OK button. Closes the Advance Settings panel.

Identify STIM 1 and STIM 2 Names

1. Press the text box next to the Name eld under the Stimulator 1 or 2 panel to open the Stimulator 1 (or 2) Name keyboard.

2. Press the Stimulator 1 (or 2) Name box.

3. Use the Scroll buttons to locate an existing probe.

4. Highlight (touch the screen) the probe name.

5. Press OK, or type the new name.

The system saves the probe name and exits.

6. Repeat for Stimulator 2 panel.

probes. Monopolar is the default. If you are using bipolar probes, you must change the probe type at this location.

stimulus pulse width.

before a warning dialog appears.

Note: Use this area if you accessed this screen from Setup/Procedure Settings/Advanced Settings. No adjustment is available if you accessed this screen from Monitoring/Control Panel/Advanced Settings.

The following is an example of a pulse width and rate adjustment performed on the Pulse Width (3) and Rate (4) panels.

Pulse width and Rate diagram (number of pulses per second)

Note: If you selected an APS procedure, then the Stimulator 2 Panel/Rate adjustment will be located on the APS Tab.

Use the Rejection Period panel (6) to do the following:

• Adjust the rejection period using the Rejection Period + or - buttons.

• Suppress the stimulus pulse artifacts during monitoring by selecting the Reject Stim Pulse Artifacts check box (7).

Stimulus Artifact Example

The Stimulus Rejection Period enables you to lter the Stimulus Artifact (electric noise caused by stimulation) and all other signals in this period.

Stimulus artifact is a monitoring term for an artifact created by stimulus voltage delivered to the patient, which is picked up as feedback either internally or externally to the monitoring equipment. It is normally small and does not impact monitoring but can, under certain conditions, be displayed and sounded on the monitor. It is important to understand the NIM system’s visual and audio feedback so as not to confuse the stimulus artifact with real EMG, or recognize if both the stimulus artifact and real EMG are present at the same time.

The on-screen stimulus artifact, when it appears on the monitoring panel display, is seen as an event (above or below threshold) which starts directly after the stimulus on the left side of the screen and proceeds for a duration into the EMG waveform detection area. The level of the artifact is directly proportional to the stimulus delivery and cannot be EMG because nerve signals need time propagate.

The stimulus artifact sound is the audio representation of stimulus artifact. It is a high frequency sound similar to cymbals and sounds like “ti - tchi.” It is unlike an EMG sound which is similar to a drum sound.

NIM-Neuro 3.0 and NIM-Response 3.0

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 NIM, Stimulus Rejection Period was referred to as Stimulus Artifact or Artifact Delay.

Special Note on Recognizing Artifact

The 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. Refer to the “Troubleshooting” topic for more information.

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.

• 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. If/when wires must cross, they should cross at right angles.

• The pace pulse generated by pacemakers may be detected and displayed by the NIM 3.0 System as a rhythmic artifact signal. This is caused by the electrode ground or stimulus return electrodes being in close proximity to the pacemaker or its lead wire(s). The 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). The 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 Ground Impedances are within tolerance (review Setup Mode/Electrode Check ).

• There 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. That 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.

Important Note on Stimulator Adjustments

By selecting a procedure, the default settings for stimulus intensity normally provide adequate stimulation. The 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:

• The functional health of the nerve itself.

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

• Proximity to the nerve.

• The pulse width of the stimulus.

You should use the amount of stimulation 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 nerves during thyroid procedures. The best guideline for setting the stimulus intensity level is to use the lowest amount that produces an EMG event. Under- and overstimulation are covered under W19, W20, and W27 in the “Warnings” topic.

NIM-Neuro 3.0 and NIM-Response 3.0

The surgeon should be aware:

• That 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.

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

Note: Stimulator adjustment involves the adjustment of the Current, 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 (5), a dialog box opens:

• Stimulus in excess of the current warning level (usually 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 mA.

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

Note: When the “Display Overlay” check box is not checked, the system does not display all other parts of the panel.

The 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 specics.

1 Overlay Mode panel 2 Overlay Position panel 3 Resolution panel 4 Overlay Training panel 5 Overlay Format panel 6 OK button. Closes the Advance Settings panel.

Use the Display Overlay selection on the Overlay Mode panel (1) to activate the microscope overlay video output.

Example

You can select between displaying any event or events resulting from stimulation.

Use the Overlay Position panel (2) to select where the system displays the overlay.

Location is ne tunable at plus or minus 60 pixels using the horizontal or vertical oset adjustment.

The resolution (3) should be set to the value specied by the microscope manufacturer.

Use the Overlay Training panel (4) to display an event until replaced with a new event, or have the display turn o after a selected period of time.

Select the Largest Channel radio button on the Overlay Format panel (5) to select where the system displays show data only or data and waveform. Example shows data with waveform.

NIM-Neuro 3.0 and NIM-Response 3.0

APS Tab (Automatic Periodic Stimulation)

1 APS Channels panel. Channels 1 and 2 checked by default. 2 Alarm panel

3 APS Stimulation panel 4 APS EMG panel 5 OK button. Closes Advance Settings panel.

Use the Alarm panel (2) to customize the following alarm settings:

• Amplitude Only sets the alarm to sound if the EMG response tolerance limit is reached regardless of the latency (default is 50% less than baseline and lower than 2000µV). You can also set an absolute alarm limit in this area. Absolute alarm limit example: If the baseline amplitude is 3000 μV, the amplitude percentage limit is 50% (1500 μV), and Amplitude Absolute limit is 1000 μV, then a signal of 1400 μV would not cause an alarm because although the signal has decreased more than 50%, it is still above the absolute limit.

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

• Absolute Alarm Adjustment. This is an actual EMG voltage response above which the percentage alarm is disabled.

• Amplitude OR Latency sets the alarm to sound if either the EMG amplitude OR the latency limit is reached.

• Amplitude AND Latency only sets the alarm to sound if BOTH the EMG amplitude AND the latency limits are reached.

• The Latency limits button is located to the right of the Increase button and toggles between percent (%) and msec.

• Percentage – this is the percentage increase in latency from the baseline latency at which an alarm condition occurs (for example, if the setting is 10%, then an alarm occurs when the amplitude goes above 110% of baseline - a 10% increase).

• msec – this is the increase in latency (in milliseconds) from the baseline latency at which an alarm condition occurs (for example, if the setting is 1.5 msec and the baseline latency is 8.0 msec, then an alarm occurs when the latency goes above 9.5 msec).

Use the APS Stimulation panel (3) to to select a “Slow Rate” and “Fast Rate” . You may switch between these rates when in monitoring. The default settings for this panel are:

• Slow Rate 10/min (10 per minute)

• Fast Rate 1/sec (1 per second).

• Baseline Rate. You can select the rate at which baseline acquisition occurs from the following values:

• 10/min

• 1/sec

• 2/sec

Note: The Pulse Width adjustment for APS is found on the Stimulation Tab Stimulator 2 panel.

Create a Baseline Measurement for an APS Procedure

You must take a baseline measurement using the Baseline button on the Monitoring screen before you can perform APS trending.

Note: When at least one channel gets a good baseline and any other channel has a median amplitude above the event threshold, the system continues the baseline stimulation pulses for up to 20 more pulses to enable those channels to meet the criteria before stopping.

1. On the Monitoring screen, press .

The Establishing APS Baseline screen appears displaying the baseline test results.

2. If you received a baseline failure (the system displays the reason for the failure in the gray box), Press to perform a new baseline test.

3. Press .

The system closes the Establishing APS Baseline window, saves your baseline, and returns you to the Monitoring screen.

NIM-Neuro 3.0 and NIM-Response 3.0

Vagus APS Stim

On the APS EMG panel, the Show APS Waveforms check box is selected by default. The system shows the waveforms from APS stimulation on the Monitoring Screen as blue with EMG response in white. Press the Mute APS EMG Audio to mute the APS EMG Audio (pop, pop, pop sound).

On the APS EMG panel you can control the following audio selections:

• Mute the APS EMG Audio using the Mute check box. If you select the Mute check box, then the EMG audio is muted for the sweeps initiated by a APS stimulation pulse. If you deselect the Mute check box, then the volume of the EMG audio for APS sweeps is controlled by the +/- adjustment provided.

• Voice - EMG Values – If you select this check box, then the NIM periodically announces the last APS EMG value audibly. Use the radio buttons to select the frequency of annunciation.

Monitoring Mode

Access the Monitoring screen by selecting the Monitor or Monitoring button. The Monitoring screen appears during surgery and shows all EMG activity.

Note: APS is not shown.

1 Tool bar 9 Scale. Displays screen scale

settings. 2 STIM 1 panel 10 Volume panel 3 Channel label. Displays

the channel number and nerve being monitored.

4 Trace. Displays stimulus

nerve activity/inactivity. 5 STIM 2 panel 13 Control Panel tab 6 Artifact Delay. Shows

where artifact ends and

EMG begins. 7 Events panel 15 Print and Save icons. The

8 Snapshot button

The STIM1 panel (2) displays the following settings:

• Stimulation setting (large numbers)

• Measured value (in the small window)

• Adjustment buttons for the STIM1 current settings.

If the STIM2 panel is inactive, it displays the Activate button. If active as a second stimulator, its display is the same as STIM1.

If an APS procedure has been selected then the APS STIM Panel appears:

Vagus APS Stim

11 Setup, Monitoring, and

Reports buttons

12 Amplitude

14 Date, Time, GUI, and DSP

version

system automatically displays these icons (on all screens with time and date bars) only if you connect a USB drive and/or a printer.

1.00

0.00 mA

Pulse Rate

APS On

Baseline

1.00

1.00 mA

Pulse Rate

APS On

Baseline

• The APS On, check box, Slow Rate, and Fast Rate buttons will be inactive (gray) until after the APS Baseline has been established.

• Refer to the APS Tab section in the Setup Mode topic for how to establish a baseline.

NIM-Neuro 3.0 and NIM-Response 3.0

Events Panel

The Events panel (7) displays the Event Threshold settings and enables you to adjust the setting level (in 5μV increments).

• EVENT THRESHOLD is 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.

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

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

Use the Snapshot Button (8) to save the current screen to memory (for reports), or to a selected peripheral device:

• Comments Icon Snapshot Option. Refer to the Control Panel topic for additional information.

• Print and Save Icon Snapshot Option. The system displays these icons automatically if a USB drive and/or a Printer are connected and you selected those devices on the Control Panel - Snapshot Action. Refer to the Control Panel topic for additional information.

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

The Volume panel (10) displays an adjustable volume setting.

You can adjust Sound levels using the volume knob on the console’s front panel (see Console Front, Item C). A numeric value and white bar graph indicate the setting relative to full scale. The default setting is 50.

The amplitude (12) displays activity level in microvolts on each channel:

• A box encloses the activity level of the highest channel.

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

• If the system detects a signal (response) outside the range of the system’s ability to measure (100,000μV or higher), the system displays the “Out of Range” message.

Control Panel

Use the Control Panel to access additional settings and monitoring features.

Press the Display button (1) to open the Scale Panel.

1 Electrode Check button 2 Freeze button. When you press the Freeze button, the system

displays the screen content, unchanged, until you press the Freeze button again. The Freeze button enables you to view an event over an extended period.

Note: The system does not display any events that take place after you press the Freeze button.

3 Measure button. Displays a cursor to view details of an event

waveform. 4 Display button 5 Events panel. Select Event Capture box and the system captures

and holds EMG activity that exceeds the Event Threshold setting. 6 Snapshot Action panel 7 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. 8 Help button. Press the Help button to view an abbreviated

assistance on the Monitor Display.

NIM-Neuro 3.0 and NIM-Response 3.0

1 The vertical portion of the EMG display represents peak-to-peak

amplitude. You can adjust the scale. The 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.

2 Time scale is represented by the horizontal portion of the EMG

display and is adjustable (refer to the Advanced Settings / Monitoring Tab). The screen is divided into equal sections. This diers from the “Amplitude scale” in that the “Time scale” selection is the entire horizontal portion of the screen.

3 OK Button, closes Scales panel.

Note: Changing either scale only aects how the data appears on the screen. It does not modify the sensitivity of the unit.

The following buttons are available on the Events/Snapshot Action panel (6) :

• Comments. Opens comments panel enabling comments and Event Titles (you may enter titles via keyboard or select them from a customized list) you wish to add to the captured event when you press the Snapshot button. The system displays these comments/title on the printed and/or saved event. Refer to the Add/Maintain Custom Titles and Comments on the Global Settings Screen topic to customize this list.

Note: You can modify Comments and Event Titles in Reports Mode.

• Print. Sends captured event to the printer with comments if you selected it when you press the Snapshot button.

• Save. Sends captured event to the USB mass storage device with comments if you selected it when you pressed the Snapshot button.

1 When you activate the Measure button, the on screen cursor (green)

shows the amplitude (μV) and 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.

2 When you press the OK button, the system turns o the cursors and

displayed values. 3 The system displays the time. 4 Cursor Position buttons move the vertical (green line) cursor left or

right in increments of 0.25mS.

The APS Monitoring Screen

APS is a process wherein a nerve at risk is continuously being stimulated. This stimulation is monitored and charted continuously in real time. You can plot and observe trends.

The plotted characteristics are:

• EMG amplitude (peak-to-peak, response to stimulation)

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

The 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.

If a measurement falls outside the limit values, the dots appear red-colored and the console issues an audible alarm to alert you depending on what alarm settings you selected on the Advanced Settings screen. Alarm mute buttons appear when in an alarm state, enabling you to mute the audible alarms.

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Medtronic 8253600 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual