Medtronic NIM4CM01 Instructions for Use

Nerve Integrity Monitor

NIM Vital ™

Instructions for use

The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

The following are trademarks or registered trademarks of Medtronic in the United States and other countries: NIM Vital™, APS™, Nervassure™, and NerveTrend™. ™* ®*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.

Table of Contents

Intended use 2

Indications for use 2

Device description 2

Contraindications 2

Warnings and precautions 2

Warnings ...........................................................................................................................................................................................2

Precautions ......................................................................................................................................................................................3

NIM quick monitoring set-up 4

The basics of what you will see and hear during monitoring .......................................................................................5

Unboxing and installing the system 5

Setting up the NIM Vital™ console ..........................................................................................................................................6

Installing the NIM Vital™ battery ..............................................................................................................................................6

Setting up the NIM Vital™ cart ..................................................................................................................................................6

Connecting NIM Vital™ accessories .........................................................................................................................................6

First time user interface setup ..................................................................................................................................................6

Set the time zone, date, time, and date/time format .......................................................................................................6

Create a surgeon prole..............................................................................................................................................................7

Saving to a surgeon prole .............................................................................................................................................7

Save custom proles to a USB drive ............................................................................................................................7

Import custom proles from a USB drive ..................................................................................................................7

Components 8

Power Cords .................................................................................................................................................................................11

Software overview 11

Turning the system on ..............................................................................................................................................................11

SETUP tab ...................................................................................................................................................................................... 11

Select user proles or default categories .......................................................................................................................... 13

Select a default procedure ........................................................................................................................................... 13

Select a user prole......................................................................................................................................................... 13

Connect Devices screen ................................................................................................................................................ 14

Check Electrode screen ................................................................................................................................................. 14

MONITORING tab ........................................................................................................................................................................ 15

EMG Display ....................................................................................................................................................................... 15

EMG display area ............................................................................................................................................................. 16

Recognizing stimulus artifacts.................................................................................................................................... 16

Understanding and recognizing other artifacts ................................................................................................... 17

MONITORING tab right panel ...................................................................................................................................... 17

MONITORING tab left panel ......................................................................................................................................... 18

NerveTrend™ (available once enabled) ...................................................................................................................20

NIM Vital™ bottom panel ..............................................................................................................................................21

NIM Vital™ top panel.......................................................................................................................................................22

Settings overview ....................................................................................................................................................................... 25

Global settings .................................................................................................................................................................. 26

Accessing settings ........................................................................................................................................................... 26

Nervassure™ settings panel ......................................................................................................................................... 26

NerveTrend™ panel .........................................................................................................................................................26

Audio panel ...................................................................................................................................................................... 27

Display Settings panel ................................................................................................................................................... 28

Stimulation panel ............................................................................................................................................................ 30

Identify STIM 1 and STIM 2 types ............................................................................................................................... 31

Important note on stimulator adjustments ........................................................................................................... 31

Titles and comments ...................................................................................................................................................... 35

Optional features in monitoring ........................................................................................................................................... 35

Quick tags ........................................................................................................................................................................... 35

Probe-based functions .................................................................................................................................................. 36

REPORTS tab ................................................................................................................................................................................. 37

Include quick tags on a report .................................................................................................................................... 38

Delete quick tags from the report ............................................................................................................................. 38

Edit the snapshot title and comments..................................................................................................................... 38

Include snapshots on a report .................................................................................................................................... 38

Edit sessions ...................................................................................................................................................................... 39

Include trending graphs in a report - Nervassure™ and NerveTrend™ ........................................................39

Edit case information on a report .............................................................................................................................. 39

Generate the report ........................................................................................................................................................ 39

Nervassure™ overview .............................................................................................................................................................. 40

Nervassure™ case set up ............................................................................................................................................... 40

Nervassure™ Monitoring Screen details .................................................................................................................. 40

Monitoring a Nervassure™ case ................................................................................................................................. 41

Thyroid with Nervassure™ specic features ...........................................................................................................43

Muting a Nervassure™ alarm ....................................................................................................................................... 43

Default Nervassure™ alarm criteria ........................................................................................................................... 44

Default Nervassure™ trend settings.......................................................................................................................... 44

Audio – understanding what you hear .............................................................................................................................. 46

Alarms .................................................................................................................................................................................. 46

Voices ................................................................................................................................................................................... 47

Tones ....................................................................................................................................................................................47

Other sounds .................................................................................................................................................................... 47

Powering down the NIM Vital™ system ..............................................................................................................................48

Resetting/powering down the console with the power button ...................................................................48

Nerve Integrity Monitor

Visual error and informational messages 48

System set-up 49

Operating room set-up .....................................................................................................................49

Anesthesia requirements .......................................................................................................50

Patient Interface setup ...................................................................................................................... 50

Stimulators ..................................................................................................................................50

Patient Interface and stimulator combinations .............................................................53

For installing the stimulating electrode ......................................................................................54

Surgery Notes ....................................................................................................................................... 54

After surgery ......................................................................................................................................... 54

When the case is complete ..............................................................................................................55

When monitoring is complete ........................................................................................................55

Managing patient interfaces 55

Power backup 55

General operation ............................................................................................................................... 55

Charging the patient interface ....................................................................................................... 55

Loss of power during surgery ......................................................................................................... 56

Console battery charging ................................................................................................................. 56

Using the console with no battery installed ..............................................................................56

Resetting/powering o the patient interface with the power button ............................56

Troubleshooting 56

Patient interface troubleshooting .................................................................................................58

Reprocessing and maintenance 58

Cleaning .................................................................................................................................................. 58

Disinfection ........................................................................................................................................... 59

Storage ....................................................................................................................................................59

Maintenance ......................................................................................................................................... 59

System self-tests .......................................................................................................................59

System quick check ................................................................................................................59

Annual planned maintenance ............................................................................................59

Annual system quick check and safety check ...........................................................................61

Cybersecurity ........................................................................................................................................ 62

Optional Accessories 62

System description .............................................................................................................................62

Simulator set-up ..................................................................................................................................62

Using the patient simulator .............................................................................................................63

Patient interface noise caused by the patient simulator and cart power supply

......................................................................................................................................................... 63

Conrming electrodes ............................................................................................................ 63

EMG Electrode lead o ........................................................................................................... 65

Stimulation ................................................................................................................................. 65

External display support ................................................................................................................... 67

Wireless display module ...................................................................................................................67

NIM Vital™ Mute adapter ..................................................................................................................67

NIM Muting detector ......................................................................................................................... 67

Muting Detector setup ...................................................................................................................... 68

Additional mute probe adapter information .................................................................70

Muting .......................................................................................................................................... 70

STIM Bur Guard .................................................................................................................................... 70

Accessories / parts list ........................................................................................................................ 70

System components & accessories ....................................................................................70

Installing the power isolator ...........................................................................................................72

NIM Probes and electrodes ..............................................................................................................73

Fuses.........................................................................................................................................................74

Patient Interface fuse replacement ...............................................................................................75

NIM Vital Wireless Medical Radio Frequency Technology 76

Wireless Quality of Service (QoS) ................................................................................................... 76

Wireless security ..................................................................................................................................76

Technical specications 77

NIM Vital Compatible Accessories ................................................................................................79

The NIM Vital™ equipment cart 79

NIM Vital™ lockdown .......................................................................................................................... 80

NIM Vital™ cart repair .........................................................................................................................80

Display default settings 82

STIM1 & 2 default settings 82

Legal information 83

Contact information ...........................................................................................................................83

Open source software disclosure ..................................................................................................83

Guidance and manufacturer’s declaration – electromagnetic emission and immunity

....................................................................................................................................................................83

Guidance and manufacturer’s declaration - electromagnetic immunities - part II

......................................................................................................................................................... 84

Limited warranty ................................................................................................................................. 85

Transmissible Spongiform Encephalopathies (TSE) ...............................................................85

Glossary................................................................................................................................................... 86

Buttons and indicators ......................................................................................................................87

Symbols .................................................................................................................................................. 90

Nerve Integrity Monitor

Intended use

The NIM Vital™ is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motorsensory nerves and registering EMG responses during surgery.

Indications for use

The NIM Vital™ system may be used for EMG monitoring in support of surgical procedures including: intracranial, extracranial, intratemporal, extratemporal and surgeries associated with the neck, spine, thorax, and upper and lower extremities.

Device description

The NIM Vital™ system is an intraoperative EMG monitor that enables users to locate and conrm the integrity of nerves during surgical procedures.

The system stimulates nerves (propagates an action potential) through a variety of stimulation probes that causes the muscle associated with the nerve to contract. The system then picks up these electric signals from the muscles through a variety of electrodes and converts this information into meaningful graphs and sounds that the system displays on the monitor.

The system also continuously monitors EMG activity from the muscles innervated by the nerve at risk.

Contraindications

The NIM Vital™ system 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 Vital™ system 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 Vital™ system 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 Vital™ 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 nerves is key to their preservation. Failure to use Medtronic’s Nerve Stimulation Probe may

contribute to unintended surgical nerve damage or resection. a. The user is responsible for ensuring the electrodes are placed, or inserted into the target muscles. The electrode check, or tap test only indicates that the electrodes are making contact with the patient’s tissue and does not indicate that the needle is inserted into the correct muscle.

W4 To avoid the risk of re or explosion, do not use the Medtronic NIM Vital™ 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 when patient interface is connected to the NIM Vital™ console through the

patient interface cord:

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 interfaces 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:

a. other than Medtronic components as damage or substandard performance could result.

b. that are damaged components or accessories.

Nerve Integrity Monitor

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 Vital™ 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 Vital™ system. W13 All service must be performed by Medtronic qualied personnel only, unless otherwise noted. 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. 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 identify nerve, a condition where probe is on nerve but you do not get an EMG tone 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V 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 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 continuous

monitoring electrodes.

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 continuous monitoring electrode from patient prior to using external debrillator to prevent thermal injury to patient

at continuous monitoring 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, if necessary, must be

properly attached to the active electrosurgical lead.

W29 User is responsible for at minimum annual functional and safety checks. W30 Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity. W31 Do not use if sterile package has been opened or is damaged.

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 Vital™ system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is

necessary, the NIM Vital™ should be observed to verify normal operation in the conguration in which it will be used.

Nerve Integrity Monitor

P5 Avoid accidental contact between ‘PATIENT APPLIED PARTS’ and other conductive parts including those connected to

protective earth.

P6 The NIM Vital™ is only compatible with the metal Muting Probe (Ref - 8220325). Earlier model Muting Probes are not

compatible.

P7 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.

P8 The patient interface is susceptible to damage from dropping. Visually inspect for damage prior to use. Inability to monitor

may result.

P9 The Ethernet connection of the NIM Vital™ Console, if activated, is intended to be connected to the hospital network. Do not

connect it to other equipment.

P10 At the end of their life cycle, all NIM Vital™ System electronic components must be sent to a WEEE recycling center or disposed

of according to local regulations.

P11 The NIM Vital™ console contains a Li-Ion battery pack that the user installs/replaces. Failure to follow the instructions for

proper installation/replacement of the Li-Ion battery pack may could result in a hazard.

P12 The Patient Interface contains a Li-Ion battery pack that must be replaced by trained service personnel only. The replacement

of Li-Ion batteries by inadequately trained personnel could result in a hazard.

P13 The multiple socket outlet (MSO) inside the locked drawer of the NIM Vital™ Cart is only intended to power the NIM Vital™

Console and NIM Vital™ Power Isolator for Printer. Connecting both NIM Vital™ Console and NIM Vital™ Power Isolator for Printer into the MSO eectively leads to create a Medical Electrical system. The system has been tested and met the applicable portions of the IEC 60601-1 standard. a. Do not plug any device into the MSO other than the NIM Vital™ Console and NIM Vital™ Power Isolator for Printer. b. Do not overload the MSO by using it for multiple systems. The MSO shall be only used for supplying power to one NIM Vital™ Console and one NIM Vital™ Power Isolator for Printer. c. Printer shall be always powered through the NIM Vital™ Power Isolator for Printer. d. Do not plug the power cord of the NIM Vital™ Cart into an extension cord or an additional MSO.

P14 The battery inside the NIM Vital™ Console can only power the system for a short period of time. NIM Vital™ system shall be

always connected to mains power for extended use and loss of power source would result in risk of loss of monitoring. P15 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. P16 A baseline EMG response should be obtained with a stimulating probe once the nerve(s) of interest are identied. Nerve

integrity should be checked with a stimulating probe then compared to the baseline throughout the procedure.

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 tab” topic for more information.

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

2. Press on the bottom right of the console display.

3. The system automatically runs the self-test until you hear the bleedle tone.

4. On the NIM Vital™ Setup screen, select the default prole followed by a surgical specialty and specic procedure to be monitored.

5. After selecting a procedure, the Connect Devices screen appears on the NIM Vital™ Setup screen. Undock the patient interface

from the console base. Wait for the solid blue paired wireless symbol to appear on the patient interface which indicates a wireless connection.

Note: If the wireless is not available, plug in the PI cord between the console and the PI. The console connector is located on the back-left side and is marked by a PI box symbol (refer to the “Buttons and indicators” and “Symbols” topics for more information).

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

6. After the patient interface connects to the NIM Vital™ system, press to progress to the Check Electrode screen. The Electrode

placement guide appears indicating how to connect the system.

7. Ensure the date and time are synchronized with the OR clock. Optional: Enter case information using the Edit Case information

button located on the top right of the screen.

8. Following the illustration on the screen, connect all color-coded cables (subdermal electrodes or EMG tube, ground, and STIM 1

return [red with white wire]) to the corresponding patient interface.

Note: The automatic electrode check shows one of the following for each connection: green bars with white checkmarks conrm the integrity of the connections. Red bars with white Xs indicate a bad connection. White, spinning icons indicate the system is checking the connection.

Nerve Integrity Monitor

9. Press , or the MONITORING tab to begin monitoring on the Monitoring screen. The NIM Vital™ system is ready to monitor with its default settings.

10. After the patient is draped, connect a sterile NIM monopolar stimulator probe to the STIM 1 jack (color-coded black plug and black socket).

The 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 tab” topic for more information.

1. The surgeon uses the stimulator probe as the primary means to conrm the location and integrity of the nerves. Refer to warning W3.

One of two events may occur:

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

• Upon stimulation of the nerve, EMG is evoked, and the default audible tone is heard at ~4X/sec and raw EMG (thump, thump, thump). The EMG event is also shown on the monitoring screen as a waveform (gure 1).

Figure 1. Biphasic EMG waveform showing 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. Between probe uses the NIM is passively monitoring muscles and you may hear changes in the EMG, or mechanically evoked nerve responses that look and sound similar to stimulator evoked nerve responses. Note: The NIM may not alert the surgeon to all types of surgical manipulation of the nerve including sharp, surgical resection.

3. The surgeon conrms the integrity of the nerve using the probe throughout the entire procedure and at the end of the procedure. Refer to the table of contents “Audio - understanding what you hear” topic for more information.

Unboxing and installing the system

Check o the contents of the box against the packing slip. If incomplete or damaged, notify customer service at +1 800 874 5797. If the container is damaged or cushioning material shows stress, notify the carrier and customer service. Keep the shipping materials

for carrier inspection. After unpacking, save the cartons and packing material. If the NIM Vital™ system is to be shipped, the shipping package will provide

proper protection.

Nerve Integrity Monitor

Setting up the NIM Vital™ console

1. Remove the NIM Vital™ console from its shipping box.

2. Place the console on a stable counter or on the NIM Vital™ cart (if purchased). Refer to the “Setting up the NIM Vital™ cart” topic for more information.

3. Install the NIM Vital™ battery that shipped separately from the NIM Vital™ system. Refer to the “Installing the NIM Vital™ battery” topic for more information.

4. While facing the NIM Vital™ console’s front, gently pull the monitor up and toward you until it reaches the desired placement.

5. Rotate the monitor until the monitor screen is facing you.

6. If you are not using the cart, plug the power cord into the socket on the rear of the console.

Installing the NIM Vital™ battery

1. Remove the two screws on the information plate located on the back of the console base between the patient interface cradles using a phillips head screwdriver.

2. Insert the battery into the battery compartment with the pull tab on the battery facing up until you feel the battery engage.

3. Replace the information plate by placing the lip on the bottom of the plate into the bottom edge of the battery compartment.

4. Align the two screw holes and replace the phillips head screws using a screwdriver.

Setting up the NIM Vital™ cart

Refer to the “The NIM Vital™ equipment cart” topic for additional information.

1. Remove the cart from its shipping crate. Refer to the uncrating instructions that ship with the shipping crate.

2. At the top of the cart, remove the tape securing the power cord and move it out of the way.

3. Place the NIM Vital™ console onto the top of the cart making sure to align the two pins on the cart with the holes in the bottom of the console.

4. Reach underneath the console tray and hand-tighten the securing knob.

5. Plug the power cord into the console.

6. Plug the 20 ft Mains power cord into the multi-socket outlet (MSO) located in the lower drawer of the cart.

7. Secure the cord using the cable clamp in the lower drawer using a phillips head screwdriver.

If you plan to add a printer to the bottom shelf of the cart, refer to the “Installing the power isolator” topic. Refer to the “Precautions” topic for additional information.

Connecting NIM Vital™ accessories

Place the patient interfaces into the cradles to begin charging them.

First time user interface setup

Refer to the “SETUP tab” topic for more information while performing a basic setup.

1. Connect unit to AC power.

2. Turn power switch On.

3. After the system completes the self-test, press .

4. Select Language (English is default).

5. Press or to close Global settings.

Set the time zone, date, time, and date/time format

1. During setup, press time/date in the lower right corner of the screen.

The System Date Time Settings dialog box appears.

2. Select the time zone from the Time Zone drop-down menu.

3. Select the date/time format using the Date Time Format drop-down list.

4. Press and select the correct date from the calendar.

5. Select the time using the Hours/Minutes/Seconds drop-down lists.

6. Do one of the following:

• Press [Conrm] and the system saves the information.

• Press [Cancel] to exit without saving the information.

Nerve Integrity Monitor

Create a surgeon prole

You can create a Surgeon prole from the Select Prole screen.

1. Click [NEW] on the initial setup screen. The New Surgeon Prole dialog box appears.

2. Press the Enter Prole Name text box. The electronic keyboard appears.

3. Type the name of the Surgeon prole.

4. Click [CONFIRM]. The Edit Prole screen appears.

5. Select a procedure(s) from the Available Procedures lists using the tabs to navigate between specialties.

6. Click to move the procedures to the Prole Procedures box.

7. Once the user moves the procedure, she/he can rename the procedure by:

• Select the procedure to rename from the Prole Procedures box.

• Press . The Edit Procedure Name dialog box appears.

• Type the new procedure name.

• Click [Conrm] or [Cancel] to either conrm the name change or cancel the change.

8. Click [Conrm] to save the surgeon prole.

9. Do one of the following:

• Select the prole to continue with the new prole.

• Press [Edit], then select the new prole to return to the Edit Prole screen and modify the prole.

• Select [Delete], then select a prole and press [CONFIRM] or [CANCEL] to either conrm the removal of the prole or cancel the removal.

Saving to a surgeon prole

Once the user creates a surgeon prole and selects a procedure, the user can save the settings changes made during monitoring into the prole’s procedure as preferences. Refer to the “Create a surgeon prole” and “Select a user prole” topics for additional information.

1. On the Monitoring screen, press .

2. After making changes, press to save all current changes. The system removes the save prole button once the system saves the settings until the next time the user changes settings. The next time the user selects the procedure from the surgeon prole, an asterisks appears next to its name to indicate it has been customized and loads with all of the saved surgeon preferences. Note: This procedure does

not save patient case information.

Save custom proles to a USB drive

1. Navigate to the Prole Selection screen.

2. Insert a USB drive.

The system detects the USB drive and appears.

3. Click the button. The system saves all custom proles.

Import custom proles from a USB drive

1. Navigate to the Prole Selection screen.

2. Insert USB drive containing saved custom proles.

The system detects the USB drive and appears.

3. Click the button. The system saves all the custom proles on the console. Refer to the “Select a user prole “ topic for additional information.

Nerve Integrity Monitor

Components

Console front

1 Power button. 2 Screen. 3 Camera. 4 Microphone.

Console left side

1 USB-A (3.0) port. 2 USB-C (3.0) port.

Console right side

1 STIM 1 adjustment knob.

2 STIM 2 adjustment knob. 3 Volume knob.

4 Mute detector adaptor connection.

Nerve Integrity Monitor

Console display bottom

1 USB-C. 2 Dual USB-A.

5 6

3 Ethernet. 4 Display port. 5 HDMI. Not specically for use with a microscope. 6 Audio (headphones).

Console base back

1 Patient interface docking cradles.

2 Wired patient interface port. 3 Battery door. 4 Earth ground (P.O.A.G.). 5 Power inlet. 6 Console fuses.

Nerve Integrity Monitor

Patient Interface

1 Electrode ground. Signal return for patient electrodes.

2 Stimulating Instrument Jack or Stimulator Probes (Monopolar or

Bipolar).

8 9

3 Incrementing Probe Control Jack. Connects Incrementing Probe controls

to the NIM Vital™.

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

5 Stimulus Return, positive (+). 6 Patient Interface to console connector.

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

tested for ECU protection.

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

wires and plugs.

9 Negative Electrode Jacks. Negative electrodes have black wires and

color-coded plugs. 10 Patient Interface Clips. 11 Docking connector. 12 Battery indicator LED. 13 Fuse indicator LED. 14 Power button. 15 Spare fuses.

Incrementing Probe Adapter

1 Connect to Incrementing probe. 2 Connect to patient interface. Note: For use with prass incrementing probe (CFN 8225825 and CFN

8225490)

Nerve Integrity Monitor

Incrementing probe

The (single use) incrementing probe provides the surgeon with the means to adjust the stimulation current at the surgical site. Refer to the “Probe-based functions” for additional information on specic button functions.

2 3 1

1. Toggle button normal or at rest.

2. Increase.

3. Decrease.

4. The user can perform the following functions with the toggle button:

• Momentary press saves the current screen to memory (for reports) and to a selected peripheral device (printer and/or USB ash drive) if the user selected that option in the settings area.

• Press and hold opens a menu on the user interface with more options.

Power Cords

1895825 Power Cord, 6 Meter, EU 1897821 Power Cord, 6 Meter Standard, U.S. 1895824 Power Cord, 6 Meter, U.K. 1895823 Power Cord, Japan, 100 V

Software overview

Turning the system on

1. Press . The splash screen appears and automatically performs an internal integrity check. Once the system completes its integrity check,

the Select Prole screen appears.

The system automatically performs an internal integrity check on the system and batteries for the console and patient interface, if docked, each time you turn the NIM Vital™ system ON. If the system encounters any errors during the self-test, the user will not be able to use the NIM Vital™ system. Refer to the “Maintenance schedule” and “Troubleshooting” topics for more information.

SETUP tab

The setup tab consists of the following screens:

Screen 1. Select Prole 1 Global settings.

2 SETUP tab.

3 Prole options. 4 Progress tracking bar.

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Screen 2. Select Category 1 Select Procedure Category (if the user selected

the default prole on the previous screen).

2 Specialties. 3 Progress tracking bar. 4 Return to previous screen.

Screen 3. Select Procedure 1 Go back.

2 Selected category.

3 Select procedure. 4 Progress tracking bar.

Screen 4. Connect Devices 1 Go back to previous setup screen.

2 Selected procedure. 3 Go to next setup screen.

4 Status of the patient interface (connected). 5 Progress tracking bar.

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Screen 5. Electrode Check

4 5 6

1 Edit Channels. 2 Go back to previous setup screen. 3 Selected procedure. 4 Channel 1 electrode check passed. 5 Channel 2 electrode check failed. 6 Ground check passed.

7 Electrode check show/hide details. 8 Stim probe selection. 9 Electrode check status bar. 10 Progress Tracking bar. 11 Proceed to monitoring.

Select user proles or default categories

The SETUP screen appears after the system has completed an internal integrity check via the splash screen.

Select a default procedure

During the setup, you can keep track of the progress of setting up the default procedure using the yellow indicator bar at the bottom of the screen.

1. Press [Default Prole] on the touchscreen. The system progresses to the next screen showing the default categories.

2. Select a default category.

3. Press one of the pre-dened procedures on the touchscreen.

The “Connect Devices” screen appears.

4. Undock the patient interface. If no patient interface is docked, dock one to register it with the NIM Vital™ system, then undock it. The system automatically begins connecting the patient interface. The Status: Connected message appears with a green border

around the Patient Interface selection box and the paired blue wireless symbol illuminates on the patient interface. Note: If a wireless connection is not available, plug in the patient interface cable between the NIM Vital™ console and the patient

interface. The console connector is located on the back, left side and is marked by a PI box symbol (refer to the “Buttons and indicators” and “Symbols” topics for more information).

5. Press on the bottom right side of the screen. Note: if you press without connecting to a patient interface (wired

or wirelessly), the Notication dialog box appears with the message, “Monitoring is unavailable until the patient interface is connected. Continue?” The user must select [CONFIRM] or [CANCEL] before proceeding to the next screen.

The Check Electrode screen appears and shows the status of the electrode check.

6. Place the electrodes on the patient according to the diagram. Refer to the “Help” topic for additional information.

7. Select the correct stimulator for the procedure.

8. Press on the right of the screen, or the MONITORING tab, to progress to the MONITORING screen. Note: If you progress to the MONITORING screen without passing the electrode check, the warning message, “Impedance check

has failed: Continue?” appears. The user must select [CONFIRM] or [CANCEL] before proceeding to the MONITORING screen.

Select a user prole

During the initial setup, you can keep track of the progress of setting up the default procedure using the yellow indicator bar at the bottom of the screen.

1. Select a pre-dened user prole. Refer to the “Create a surgeon prole” topic for additional information.

2. Press one of the pre-dened procedures on the touchscreen. The Connect Devices screen appears. Refer to the “Connect Devices” topic for more information.

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3. Undock the patient interface. The system automatically begins connecting the patient interface. The Status: Connected message appears with a green border

surrounding the Patient Interface selection box and the paired blue wireless symbol illuminates on the patient interface. Note: If a wireless connection is not available, plug in the patient interface cable between the NIM Vital™ console and the

patient interface. The console connector is located on the back, left side and is marked by a patient interface symbol (refer to the “Buttons and indicators” and “Symbols” topics for more information).

4. Press on the bottom right of the screen. The Check Electrode screen appears and shows the status of the electrode check. Refer to the “Check Electrode screen” topic for

additional information.

5. Place the electrodes according to the diagram. Refer to the “Electrode placement” topic for additional information.

6. Select the correct stimulator for the procedure.

7. Press on the bottom right of the screen, or the MONITORING tab, to progress to the MONITORING screen. Note: If you progress to the MONITORING screen without passing the electrode check, the warning message, “Impedance check

has failed: Continue?” appears. The user must select [CONFIRM] or [CANCEL] before proceeding to the MONITORING screen. The Monitoring screen appears.

Connect Devices screen

The following information is located on the Connect Devices screen.

The symbol appears in the top right-hand corner of the screen when the patient interface is cradled.

Wireless connection

Undocking the patient interface initiates an automatic wireless connection to the console. The Status: Connected message appears with a green border around the Connect device box and the paired light will illuminate on the patient interface.

The symbol appears in the top right-hand corner of the screen when the patient interface is connected wirelessly. Note: Only undock the patient interface you plan to use. Once undocked, the system automatically connects to the patient interface

that is undocked rst. If you need to switch connection to the other patient interface, replace the rst patient interface into its dock and undock the other patient interface box.

Wired connection

If a wireless connection is not available, plug in the patient interface cable between the NIM Vital™ console and the patient interface. The console connector is located on the back-left side and is marked by a patient interface symbol (refer to the “Buttons and indicators” and “Symbols” topics for more information).

The symbol appears in the top right-hand corner of the screen when the patient interface is connected with a cable.

Check Electrode screen

The Check Electrode screen assists you with electrode placement. The surgeon should insert the electrodes into the appropriate target muscle location innervated by the monitored nerve. The

surgeon should then insert the ground electrode (green) and the stim return (white) as shown in the electrode placement diagram. Once the surgeon places the electrodes on the patient, the surgeon needs to insert the other end of the electrodes into the patient interface to complete the electrode setup. NIM Vital™ systems include nerve and electrode placement guides that are color-coded to help reduce confusion.

The electrode placement guide contains some, but not all, possible electrode placements. Press on the SETUP screen for an additional list of electrode placement guides ( Refer to the help section for electrode placement diagrams).

When the system runs an electrode check, this screen shows the electrodes the system is testing.

• Green bar with white check marks indicate the electrode is connected to the corresponding channel.

• Red bar with white Xs indicate the connection is incomplete.

• A spinning icon indicates the system is calculating.

If you connected all the electrodes properly, all channels will have green check marks indicating the electrode check has passed.

Select the correct stimulator for the procedure and then press to proceed to monitoring. STIM 1, STIM 2, Ground - If a spinning icon appears after the system has completed the test, no channel electrode or ground was

connected, so the system reads that as a 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.

Nerve Integrity Monitor

If the user needs detailed values, press to show the more detailed impedance menu. If showing details, use the drop-down menus on the Electrode Type panel (the only screen where you can adjust the electrode type in use) to select the type of electrode you want to use. Refer to the “Troubleshooting” topic for information on electrode troubleshooting.

Note:

• You can bypass the next place electrodes screen by selecting the MONITORING tab or .

• If you bypass the Check Electrode 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 exit the Check Electrode screen, any printed reports will show a failure of the impedance values of the disconnected item(s).

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

• STIM2 appears after you turn it on using the Activate button located on the main screen, or by selecting the STIM2 from the drop-down list on the Stimulation Panel.

Edit channel names

From the Electrode Check page, the user can open the Edit Channels panel. This panel enables adding, editing, and removing channels from the selected procedure. Once changes have been made, select [Apply Changes] to use the settings in the current procedure only, or select [Save to Prole] to save the channels for current and future use. The user can also reset changes to the latest save point (or to default in a default procedure) by selecting [Reset to Saved].

MONITORING tab

Access the MONITORING screen by pressing MONITORING on the top tool bar, or . The main monitoring screen helps provide EMG information to the surgeons. The EMG information can be free running and

stimulation evoked.

EMG Display

Free-running EMG

If the user has Event Capture disabled on the Threshold panel, the NIM Vital™ system continuously displays free running EMG picked up by the electrodes. If the user enables Event Capture, the system only displays values above the threshold values.

Evoked EMG

The surgeon can use the stimulator probe to conrm the location and integrity of the nerves. When the surgeon touches the surgical site with the STIM probes, one of the two following events happen:

You can expect one of two events:

• Stimulation with an EMG response - This event occurs when the stimulation device touches healthy nerve tissue that is capable of propagating an action potential that reaches its innervated muscle tissue. The surgeon will notice the following on the console: — Audio (thump, thump, thump, thump) — Biphasic wave form — An amplitude value — A STIM measured value

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• Stimulation of tissue, but no EMG response - This event occurs when the stimulation device touches non-nerve tissue, or if the

current delivered is not sucient to propagate an action potential. The surgeon will notice the following on the console: — Hear the current delivery tone — See a STIM measured value

A detailed list and explanations of all the monitoring screen buttons are displayed below.

1 Scale. Displays screen scale settings.

2 Settings button. 3 Save Prole button (only when settings have been

changed, but not saved into a prole).

4 Trace. Display stimulus nerve activity/inactivity. 5 Adjust view. 6 Snapshot button. 7 Freeze button (when activated). 8 Measure button (when activated).

9 Check Electrodes button. 10 Baseline button (only active if the user activates it

on the settings panel).

11 Channel label. Displays the channel number and

nerve being monitored.

12 Amplitude.

13 Stim panels. 14 Stim return value. 15 Threshold panel. 16 Show details button. Provides access to event

capture and adjust threshold.

17 Volume panel. Adjust the system volume.

EMG display area

The amplitude displays activity level in microvolts on each channel:

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

• When the STIM probe is removed and “Largest Overall” is selected, a box encloses the channel with the largest event.

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

• Absolute Amplitude Limit: The Absolute Amplitude Limit (in uV) and the Amplitude Percentage Limit (in %) are used in conjunction to determine the APS amplitude alarm criteria. The lower of the two limits sets the alarm limit. For example, if the baseline amplitude is 2000 V, Amplitude Percentage limit is 50%, and Absolute Amplitude limit is 500 V, then a signal of 800 V would not cause an alarm because although the signal has decreased more than 50%, it is still above the Absolute Amplitude limit.

Recognizing stimulus artifacts

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.

Nerve Integrity Monitor

The stimulus rejection period enables you to lter the stimulus artifact (electric noise caused by stimulation) and all other signals in this period.

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

Understanding and recognizing other artifacts

The NIM Vital™ 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 Vital™ 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 may not provide automatic synchronized muting with the NIM Vital™ 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 Vital™ system wires.

• The pace pulse generated by pacemakers may be detected and displayed by the NIM Vital™ 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 operative 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 Vital™ 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.

MONITORING tab right panel

STIM 1

The STIM1 panel displays the following settings:

• Stimulation setting (large numbers in mA units)

• Measured value (small numbers)

• Adjustment buttons for the STIM1 current settings.

• You can adjust the current of the stimulator plugged into the STIM 1 port using or , or the knobs located on the side of the

monitor. Refer to the “Stimulation panel” topic for more information.

STIM 2

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. You can adjust the current of the stimulator plugged into the STIM 2 port using or , or the knobs located on the side of the

monitor. Refer to the “Stimulation panel” topic for additional information.

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Threshold

Use threshold to dene where EMG activity becomes signicant. EMG activity exceeding the threshold is dened as an event and results in event tones. Any activity below this threshold does not trigger an audible event.

Show details/event capture

The Threshold panel displays the threshold settings and enables you to adjust the setting level (in 5, 10, or 100V increments

depending on the Threshold value). Press to access the threshold settings and then press or to increase or decrease the

value as desired. The system displays the setting in micro-Volts. Press to access the Event Capture toggle button. When event capture is enabled, the system captures any waveform above the event threshold. The event capture stays on the screen until the next waveform above the threshold appears.

Volume

The Volume panel displays an adjustable volume setting.

You can adjust sound levels using or in 5% increments. The default setting is 50.

MONITORING tab left panel

The NIM Vital™ left panel contains the following items you can use to adjust the monitoring screen.

Baseline

You can create a baseline and then manually trend future stimulations against the baseline using the trend function. For Nervassure™ continuous monitoring, select a Nervassure™ procedure on the Select Procedure screen during initial setup. For nonNervassure™ procedures, you can use the NerveTrend™ function which works similarly to the trend function.

Electrode Check button

The Electrode Check panel checks the integrity of the patient to the patient interface connections.

1 Electrode check button. Opens/

closes Electrode Check panel.

2 STIM1, STIM2, and Ground status

elds.

3 Electrode Show Details status eld:

• Green check marks. Green check marks appear when the electrodes are connected

correctly.

• Spinning icons. Spinning icons appear while the system runs the electrode test.

• Red X. A red X appears when the electrodes are connected incorrectly or fail.

4 The system disables monitoring

when the Electrode Check panel is open.

5 Show/hide details button.

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 1, STIM 2, Ground - If a spinning icon a question mark appears after the system has completed the test, no channel electrode or ground was connected, so the system reads that as a 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.

Electrode check

You can perform an electrode check on the MONITORING screen using .

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Electrode Check panel pass/fail

The system measures impedance values of the electrodes to the patient to conrm the integrity of the connection. The electrode check only indicates that the electrodes are making contact with the patient’s tissue. The system does not conrm that the needle is inserted into the correct muscle. The user is responsible for ensuring the electrodes are placed, or inserted into the target muscles.

The above graphic illustrates that all channels have passed the electrode check. A red bar with a white X will replace the green bar with a white checkmark if a channel(s) fails.

Electrode Check Show Details button

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

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

Measure

When activated, press to enable and adjust the measurement cursor. Refer to the “Display settings” topic for additional information.

1. Enable the Measurement cursor on the main screen.

2. Select the cursor type. This determines where the cursor is initially displayed.

3. Adjust the cursor position.

Freeze

When activated, press to freeze the current waveform on the screen. The main screen shows “Display is Frozen” during this

time. Press again to end the freeze. Monitoring continues in the background when enabled and monitoring sounds still play.

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Adjust view

Press to adjust the scale (Y-axis V [amplitude] and x-axis mS [milli-seconds]).

1 Adjust View button. 2 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.

3 Time scale is represented by the horizontal portion

of the EMG display and is adjustable. 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. Note: Changing either scale only aects how the

data appears on the screen. It does not modify the sensitivity of the unit.

Snapshot

Use the Snapshot Button to save the current screen to memory (for reports). Based on options selected in Settings/Display, taking a snapshot can also ask for additional comments, print, and/or save to le on a connected USB.

Save Prole

Press [Save Prole] to save any current settings changes to a user prole. If the user is in a default prole pressing [Save Prole] asks the user to enter a new prole name and automatically adds the procedure to the prole. If the user is in a custom prole pressing [Save Prole] updates existing stored procedure settings.

Settings

Use the Settings panel to access additional settings/advanced settings and monitoring features.

1 Settings button.

4 3

2 6

2 Stimulation settings. 3 Display settings. 4 Audio settings. 5 NerveTrend™ or Nervassure™

settings (if enabled).

6 Titles and Comments.

NerveTrend™ (available once enabled)

NerveTrend™ enables users to manually track the status of a nerve over time. The system records EMG responses that the user captures and plots over time using a graph.

Creating a NerveTrend™ baseline

1. Press .

2. Select Display.

3. Expand Additional Features.

4. Toggle Enable NerveTrend™ to On.

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5. Press . The NIM Vital™ system performs a number of measurements (minimum of 20) and shows the results for channels one and/or two

with the amplitude and latency (if enabled).

6. Do one of the following:

• Press [Cancel] to return to MONITORING without creating a baseline measurement.

• Press [Re-evaluate] to direct the system to restart the baseline measurement.

• Press [Continue] to use the system’s measurements. If you pressed (insert continue button), the Operating Side panel appears.

7. Select an operating side which auto-generates as session title.

8. Change the session title or add session comments, if desired.

9. Press [Accept].

Using the NerveTrend™ feature

1. Identify a proximal location on the nerve at risk.

2. Stimulate the nerve at the proximal location using the supramaximal stimulus value.

3. Initiate a NerveTrend™ baseline. Refer to the “Probe-based functions” and “NerveTrend™” topics for additional information.

4. After a successful baseline acquisition, stimulate the same anatomical location at the same stimulus intensity and document the EMG response on the graph using the incrementing probe buttons or the Trend button on the NIM Vital™ system (stimulation at a modied intensity causes responses to appear as grey indicating that they cannot be graphed. Returning the stimulation intensity to the baseline level and repeating stimulation allows graphing to continue).

Note: the user can repeat this step multiple times throughout the procedure to visualize a change in the nerve function.

NIM Vital™ bottom panel

The bottom panel of the NIM Vital™ displays the following informational symbols.

1 Data recording (on). 2 System is running on console battery (or No Mains power

connected). 3 Take a screenshot. 4 Patient interface battery status. 5 Date/time (settings if in Setup).

4 5

Battery status

The user can view the battery status using . The battery indicator enables the user to see the remaining battery in the Patient Interface. A lightning bolt icon appears on the bottom right of the display when the battery is charging.

Recording icon

If the user has enabled data recording, the recording icon appears on the bottom panel until the user turns o the setting.

Console battery icon

The console battery icon slowly pulses when the console detects that it has lost main A/C power. It remains until the console detects it has regained A/C power.

Screenshot icon

The screenshot icon appears when the console detects a mounted, approved USB. Taking a screenshot captures the entire screen (not just a waveform) and saves it directly to the USB.

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NIM Vital™ top panel

You can view, add, and update patient information using the Edit case information button located on the top panel of the NIM Vital™. You can also access the NIM Vital™ Help screen and view the connected devices.

1 Global settings. 2 Current procedure.

1 2

5 6

Edit/congure case information button

The Congure case information setting enables the user to choose which elds appear on the Edit case information panel. The Edit case information panel opens when you press the Edit Case Information button. Use this screen to enter data into

preselected data elds. The user can modify the Data elds displayed by selecting the icon on the top left of the Edit case information panel. In the Congure Case Information window, the user can turn on/o each data eld for display in the Edit case information panel. Select [Save to Prole] to keep the changes in a surgeon prole, or [Conrm] to save the changes for the current case.

3 SETUP tab. 4 MONITORING tab. 5 REPORTS tab. 6 Edit case information button. 7 Type of patient interface connection. 8 Help button.

1 Congure Case Information setting. 2 Select Items to Include in Case Information. 3 SAVE TO PROFILE. 4 CONFIRM.

1 Edit Case Information. Press any of the information elds

to open the keyboard for data entry. Changes are saved

automatically.

2 Patient ID.

3 First Name. 4 Last Name.

5 Date of Birth. 6 Prole Name.

7 Close the Edit Case Information screen.

1. From the MONITORING screen, press the Edit Case Information button. The Case Information screen appears.

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

3. Repeat step 2 and 3 for the following information depending on conguration:

• Patient ID

• Patient Name

• Patient DOB

• Notes

4. Press the reverse arrow button on the right side panel. The system returns you to the previous screen.

Help

1 Electrode Placement.

1 2 3

4 5

2 Audio Samples. 3 User Manual. 4 LOS Troubleshooting. 5 Contact. 6 Close Button.

Nerve Integrity Monitor

The Help screen displays help graphics for locating electrodes, sample audio sounds, an electronic version of the IFU, LOS troubleshooting, and contact information.

You can use the Help screen to view electrode placement graphics which aids in the 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.

1. In the top right-hand corner of the screen, press . The Help screen appears.

2. Press [Electrode Placement]

3. Place electrodes according to the appropriate help graphic.

4. Press [Close] to return to the current screen.

Note: When the user accesses the Help screen from the MONITORING screen, the system disables monitoring. Electrode placement

The surgeon should insert the electrodes into the appropriate muscle location innervated by the monitored nerve. The surgeon should then insert the ground electrode (green) and the stim return (white) as shown in the electrode placement diagram. Once the surgeon places the electrodes on the patient, the surgeon needs to insert the other end of the electrodes into the patient interface to complete the electrode setup. NIM Vital™ systems include nerve and electrode placement guides that are color-coded to help reduce confusion.

The electrode placement guide contains some, but not all, possible electrode placements. Press on the top right-hand corner of the screen for an additional list of electrode placement guides.

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Listen to audio samples

You can use the Audio Samples tab on the Help screen to hear multiple types of audio.

1. On the SETUP screen, press . The Help screen appears.

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2. Select the Audio Samples tab.

3. Select any of the following audio samples:

• Pulse

• Train

• Burst

• Event tone

• Current Delivery tone

4. Press [Close] to return to the SETUP screen.

Note: When the user accesses the Help screen from the MONITORING screen, the system disables monitoring. View the Instructions for Use

1. On the SETUP screen, press The Help screen appears.

2. Select [User Manual]. The Instructions for Use appears in the right pane.

3. Use the scroll bar on the right to scroll through the Instructions for Use.

4. Select [DOWNLOAD] (appears when the system detects a mounted, approved USB). The system downloads the .pdf le the USB drive. Note: The user receives a message stating the system saved the document to

the USB drive after ve seconds. You must wait at least two minutes before removing the USB drive though. It takes the system at least two minutes to complete the download.

5. Press [Close] to return to the current screen.

Note: When the user accesses the Help screen from the MONITORING screen, the system disables monitoring. View the LOS troubleshooting information

1. In the top right-hand corner of the screen, press . The Help screen appears.

2. Press [LOS Troubleshooting].

3. View the intraoperative LOS troubleshooting algorithm.

4. Press [Close] to return to the current screen.

Note: When the user accesses the Help screen from the MONITORING screen, the system disables monitoring. View contact information

1. In the top right-hand corner of the screen, press . The Help screen appears.

2. Press [Contact].

3. View Medtronic’s contact information/Remote assistance.

4. Press [Close] to return to the current screen.

Note: When the user accesses the Help screen from the MONITORING screen, the system disables monitoring.

Connected devices

The user views the status of connected devices using . The Connected Devices panel provides detailed information on any connected patient interface whether it is docked, wirelessly connected, or wired.

Settings overview

Settings/Advanced settings adjustments made in the MONITORING mode lasts for the duration of the session unless the user presses [Save Prole] which saves the changes in a prole.

Nerve Integrity Monitor

Global settings

Press to access the Global Settings menu on any screens.

1 Global Settings screen. 2 Case panel. Press [End case] to end the current case and return to the Select Proles

screen.

3 Information panel. Access the following screens:

• About

• Help

4 USB panel (appears when the system detects an approved, mounted USB drive). Press

[Unmount USB drive] to safely remove the USB drive.

5 Power options panel. Press [Shut down] to shut down the NIM Vital™ system. 6 Select a Language drop-down menu.

7 Close the Global settings panel.

Accessing settings

The user can only access/modify these settings from the MONITORING tab.

1. Press . The Settings slider panel buttons appear (for example: ).

2. Select one of the following settings you want to adjust:

• Nervassure™ (available when enabled).

• NerveTrend™ (available when enabled).

• Audio.

• Display.

• Stimulation.

• Titles and Comments The panel slides out enabling you to make the adjustments.

Note: to open any Advanced Settings panel, the user must accept a dialog box that warns her/him about modifying advanced settings.

Nervassure™ settings panel

Refer to the “Nervassure™ settings” topic for additional information on Nervassure™ settings.

NerveTrend™ panel

The user must enable the NerveTrend™ panel using the Display panel. Go to Display/Additional Features/Enable NerveTrend™ toggle button. Once the user selects Enable NerveTrend ™“on”, the system shows the NerveTrend™ panel and the user can now access the NerveTrend™ settings/advanced settings.

Note: If you adjust the advanced settings, you will change the default characteristics of your NIM Vital™. Only someone with

knowledge of the advanced settings and how they impact your NIM Vital™ should make changes. If the user selects , the system displays a warning. The user must select [Cancel] or [Conrm] to return to settings or move forward to the advanced settings panel.

Nerve Integrity Monitor

1 Settings button. 2 NerveTrend™ settings.

3 Trending Display expand/collapse menu:

• Trend Latency.

• Show connectors.

• Show Entire Session.

• Show as Mountain Graph. 4 NerveTrend™ settings advanced settings. 5 NerveTrend™ Channels. 6 NerveTrend™ Color Conditions expand/collapse menu:

• Color Display Criteria.

• Amplitude Threshold.

• Absolute Threshold.

• Latency Threshold.

On the NerveTrend™ settings panel you can select the following diverse types of trends to track:

• Trending Display settings - you can toggle on/o the following settings from the Trending Display settings panel: — Trend latency - Turn on latency for the trending area. — Show Connectors - Display connecting lines between trend points. — Show Entire Session – When enabled, the system displays the entire session in the trend window. When disabled, the trend is

on a rolling timeframe that only shows the most recent portion of the trend session.

— Show as Mountain Graph - Change the visual layout of the trend.

• Color Conditions - View the alarm color conditions. The Color conditions depend on the Alert Type setting (amplitude/latency). The user must enable Trend Latency to use a latency Alert Type.

NerveTrend™ advanced settings

On the NerveTrend™ advanced settings panel you can adjust the following:

• NerveTrend™ Channels - Toggle on/o the EMG channels in the procedure to trend.

• NerveTrend™ Color Conditions - You can adjust the following color condition information:

— Condition Type (amplitude only, latency only, amplitude AND latency, Amplitude OR latency) — Amplitude Threshold — Latency Threshold

Audio panel

Refer to the “Audio – understanding what you hear” topic for more information on the Audio tab. Note: If you adjust the advanced settings, you will change the default characteristics of your NIM Vital™. Only someone with

1 Settings button.

2 Audio panel. 3 Stimulus Delivery Audio.

4 Monitoring EMG Audio:

• EMG Audio.

• Event Tones.

• Voice - Stimulated EMG Values.

• Show Channel Mute Button.

5 Volume Balance:

• EMG Audio Volume Balance.

• Event Tones Volume Balance.

• Voices Volume Balance.

6 Audio Advanced Settings. 7 Active Stimulus Only.

+ 65 hidden pages

Medtronic NIM4CM01 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual