Medtronic NCCPUE4 Instructions for Use

NIM-Eclipse™ E4 SD

Nerve Monitoring System

User’s Manual

Software Version 4.3

CUSTOMER SERVICE For further information regarding the use of this product or to report any problems, please contact Medtronic using the appropriate information provided on the contact information card packaged with each device; or contact your local distributor.

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.

© 2021 Medtronic. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

Table of Contents

Device description ............................................................................................................ .... 1-1

Indications for use ............................................................................................................. .... 1-1

Target patient population .............................................................................................. .... 1-1

Intended use ....................................................................................................................... .... 1-1

Contraindications .............................................................................................................. .... 1-1

Warnings and Precautions ............................................................................................. .... 1-1

Warnings ...................................................................................................................... .... 1-1

Precautions .................................................................................................................. .... 1-3

Training requirements ..................................................................................................... .... 1-4

Residual risks ....................................................................................................................... .... 1-4

Possible adverse events .................................................................................................. .... 1-4

Material composition ....................................................................................................... .... 1-4

Section 2: Setting up Hardware

System components and software ............................................................................. .... 2-1

System accessories ........................................................................................................... .... 2-1

Unpack the system ........................................................................................................... .... 2-1

Shipping and storage environment ................................................................... .... 2-1

System components descriptions ............................................................................... .... 2-2

NIM-Eclipse™ System controller ........................................................................... .... 2-2

Patient Interface Module (PIM) ............................................................................ .... 2-3

Probe outputs ............................................................................................................. .... 2-3

Pulse Oximeter ........................................................................................................... .... 2-4

Electro-Surgery Unit mute probe ....................................................................... .... 2-4

NIM-Eclipse™ System computer .......................................................................... .... 2-4

Power Controller Unit .............................................................................................. .... 2-4

Connecting the system components ......................................................................... .... 2-5

Connection guide ..................................................................................................... .... 2-5

Patient Interface Module connection ................................................................ .... 2-5

Powering on the system ................................................................................................. .... 2-6

Patient Interface Self-Test ....................................................................................... .... 2-6

Section 3: Quick Start and Stop

Quick start procedure ...................................................................................................... .... 3-1

Monitoring Options .................................................................................................. .... 3-1

Quick stop procedure ...................................................................................................... .... 3-1

Section 4: Creating and Modifying Protocols

NIM-Eclipse™ System Run/Modify Test selection screen..................................... .... 4-1

NIM-Eclipse™ System Resume/Review Test selection screen ............................ .... 4-2

Create a protocol ............................................................................................................... .... 4-3

Modify a protocol .............................................................................................................. .... 4-3

Run a test .............................................................................................................................. .... 4-3

Start/Stop ............................................................................................................................. .... 4-3

Run test functional keys .................................................................................................. .... 4-4

Resume a test ...................................................................................................................... .... 4-4

Resume a test after accidental power loss ............................................................... .... 4-4

Patient Information ......................................................................................................... .... 4-5

Personal ........................................................................................................................ .... 4-5

Case Sta ...................................................................................................................... .... 4-5

Case Details ................................................................................................................. .... 4-6

Monitored Modalities, Alerts, Alarms................................................................. .... 4-6

Case Info ....................................................................................................................... .... 4-6

Create a Patient Prole .................................................................................................... .... 4-7

Modify a Patient Prole ................................................................................................... .... 4-7

Delete a Patient Prole .................................................................................................... .... 4-7

Edit Lists ................................................................................................................................ .... 4-7

System Settings.................................................................................................................. .... 4-8

General tab .................................................................................................................. .... 4-8

Colors tab ..................................................................................................................... .... 4-9

Training tab ................................................................................................................. .... 4-9

Congure Channels .......................................................................................................... .. 4-10

Verifying Impedances .............................................................................................. .. 4-10

Selecting a Channel Mode ..................................................................................... .. 4-10

Setting a Channel On/O ....................................................................................... .. 4-10

Naming Channels ...................................................................................................... .. 4-10

Raw EMG Modality ............................................................................................................ .. 4-11

Triggered EMG Responses ............................................................................................. ..4-11

Neural Proximity Test Mode ........................................................................................... .. 4-12

Pedicle Screw Integrity Test ........................................................................................... ..4-13

Nerve Root Test .................................................................................................................. ..4-13

Train of Four (TOF)............................................................................................................. ..4-14

TOF Stimulation Artifacts ....................................................................................... ..4-14

Graph ............................................................................................................................. .. 4-15

Responses .................................................................................................................... .. 4-15

Motor Evoked Potential (MEP) ...................................................................................... .. 4-15

D WAVE .................................................................................................................................. .. 4-16

Speech Mapping ............................................................................................................... ..4-16

Motor Mapping .................................................................................................................. .. 4-17

Modality Settings .............................................................................................................. .. 4-17

Trace Panel ................................................................................................................... .. 4-17

Stack Settings ............................................................................................................. ..4-18

Numeric Settings ....................................................................................................... .. 4-19

Markers Settings ........................................................................................................ .. 4-19

Stimulus Settings ............................................................................................................... .. 4-20

Electrical Stimulus Advanced Settings Window ............................................ ..4-20

Secondary Windows Settings ....................................................................................... .. 4-22

Timer 1 .......................................................................................................................... ..4-22

Surgeon Screen .......................................................................................................... .. 4-22

Camera 1 ...................................................................................................................... ..4-22

Speaker Settings ................................................................................................................ .. 4-22

Comments settings........................................................................................................... ..4-23

System generated comments ............................................................................... ..4-23

User entered comments ......................................................................................... ..4-23

Predened comments ............................................................................................ .. 4-23

Auto Comments ................................................................................................................. ..4-24

Show Comments ............................................................................................................... ..4-24

Comments File .................................................................................................................... ..4-24

Section 5: Monitoring and Review

NIM-Eclipse™ System Monitoring Screen ................................................................. .... 5-1

Monitoring screen sections ........................................................................................... .... 5-2

Pulse Oximeter window .......................................................................................... .... 5-2

EMG Tests window .................................................................................................... .... 5-2

Trace window ............................................................................................................. .... 5-2

Stack window ............................................................................................................. .... 5-2

Spine View window .................................................................................................. .... 5-3

Timer window ............................................................................................................. .... 5-3

Speech mapping window ...................................................................................... .... 5-3

Probe control of menu functions ................................................................................ .... 5-3

Dragging Elements in Trace and Stack Windows ................................................... .... 5-3

Right-click windows menu ............................................................................................ .... 5-3

Include Channels for Autotesting ....................................................................... .... 5-4

Clear Traces .................................................................................................................. .... 5-4

Next Average .............................................................................................................. .... 5-5

Baselines ....................................................................................................................... .... 5-5

Reset EP Traces ........................................................................................................... .... 5-5

Cursors dialog ............................................................................................................. .... 5-6

Add alert/alarm .......................................................................................................... .... 5-7

Other right-click options ........................................................................................ .... 5-7

System menu ...................................................................................................................... .... 5-8

Screenshot capture ........................................................................................................... .... 5-8

Screen and window view customization .................................................................. .... 5-8

NIM-Eclipse™ System Review Data Screen ............................................................... .... 5-9

Review a test ....................................................................................................................... ..5-10

NIM-Eclipse™ System Review Data Functional Keys ............................................. .. 5-10

Print Settings ....................................................................................................................... .. 5-11

Output ........................................................................................................................... .. 5-11

Select Reports............................................................................................................. ..5-11

Professional Report .................................................................................................. ..5-11

Report Header ............................................................................................................ .. 5-11

Report Parameters .................................................................................................... .. 5-11

Report Generator .............................................................................................................. ..5-12

Templates ..................................................................................................................... .. 5-12

Lists ................................................................................................................................. .. 5-13

Printing ......................................................................................................................... ..5-14

Saving the Report ..................................................................................................... ..5-14

Formatting Text .......................................................................................................... .. 5-14

Report Tables ...................................................................................................................... ..5-15

Example: Text Layout Using Tables ..................................................................... ..5-16

Create and Edit Report Templates ............................................................................... ..5-17

Adding Data Fields ................................................................................................... ..5-17

Section 6: Remote Monitoring

NIM-Eclipse™ System remote monitoring ................................................................ .... 6-1

Clinical system remote monitoring session ............................................................. ......6-1

Remote system remote monitoring session ............................................................ ......6-2

OR Time ................................................................................................................................. ......6-3

Text chat ............................................................................................................................... ......6-3

Troubleshooting remote connections ....................................................................... ......6-4

Section 7: System Information

Sterility .................................................................................................................................. ......7-1

Cleaning and maintenance............................................................................................ ......7-1

Cleaning........................................................................................................................ ......7-1

Disinfection ................................................................................................................. ......7-1

Disposal................................................................................................................................. ......7-2

Technical support .............................................................................................................. ......7-2

Limited warranty ............................................................................................................... ......7-2

Technical Specications .................................................................................................. ......7-3

System overview ....................................................................................................... ......7-3

EMG Mode ................................................................................................................... ......7-4

Neural Proximity Mode ........................................................................................... ......7-5

Screw Test Mode ........................................................................................................ ......7-5

Nerve Root Test Mode ............................................................................................. ......7-5

TOF Test Mode ............................................................................................................ ......7-6

MEP Test Mode ........................................................................................................... ......7-6

D Wave Test Mode ..................................................................................................... ......7-6

Speech Mapping Test Mode .................................................................................. ......7-6

Motor Mapping Test Mode .................................................................................... ......7-7

Patient Interface Module ........................................................................................ ......7-7

System architecture .................................................................................................. ......7-8

Operational environment ...................................................................................... ......7-8

Guidance and manufacturer’s declaration – electromagnetic emission and im-

munity .................................................................................................................................. ......7-9

Part I ............................................................................................................................... ......7-9

Part II .............................................................................................................................. ... 7-10

Troubleshooting ................................................................................................................ ...7-11

Symbols ............................................................................................................................... ...7-14

Introduction

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.

Device description

The NIM-Eclipse™ System is an eight-channel EMG and evoked potential monitor for intraoperative use during surgeries in which a motor nerve is at risk due to unintentional manipulation. The NIM-Eclipse™ 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.

Indications for use

The NIM-Eclipse™ System is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials, and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

The system provides feedback to the surgeon and operating room team to assist in the localization and assessment of spinal nerves and verication of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Target patient population

The NIM-Eclipse™ System is used during minimally invasive and open operative surgical procedures in various locations of the body with peripheral and/or central nervous system involvement in adult patients where intraoperative neuromonitoring is appropriate. It is designed to be used by neurophysiology clinicians, technicians or surgeons.

Intended use

The NIM-Eclipse™ System is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. Indicated surgical procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, thoracic surgeries, and upper and lower extremities.

Contraindications

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

Comprehensive relative contraindications for transcranial electrical motor evoked potentials (MEP) include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices. Otherwise, unexplained intraoperative seizures and possibly arrhythmias are indications to abort MEP.

Warnings and Precautions

It is important that the NIM-Eclipse™ System operator be familiar with this manual, device warnings and precautions, procedures and safety issues.

Warnings

W1 The NIM-Eclipse™ 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 To avoid alternate site patient burns or lesions:

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

• Do not leave dissection instruments, stimulating electrodes or probes in surgical eld.

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

• Do not allow a second surgeon to use electrosurgical instrument while stimulator is in use.

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

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

• Do not allow Stimulators, Digital Preampliers, or recording/stimulating electrodes sites to be ooded with saline.

• Do not allow excessive stray AC or DC leakage currents from patient-connected equipment; avoid creating an unintended grounding path through applied electrodes.

• Verify that the ESU return electrode is properly applied and making good contact with the patient.

• Do not use the ESU return electrode as the patient ground connection for the NIM-Eclipse™ System.

• Do not place the ESU return electrode above or near the NIM-Eclipse™ System recording or stimulating electrodes.

• Do not connect the patient or patient ground electrode to grounded metal objects or to earth ground, either directly or indirectly.

• Avoid using non-approved external patient connected devices, which may create pathways from the patient to earth ground.

• Practitioner is responsible for proper use, periodic safety certication of patient connected equipment, and AC power grounding in accordance to appropriate IEC 60601-1 and/or IEC60601-1-1 medical safety standard.

W3 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 may result in neural tissue damage or injury to exposed tissue. Do not exceed an energy level of 50 mJ per pulse (measured into a 1 kilo-ohm load).

1-1NIM-Eclipse™ E4 SD

Introduction

W4 While Muting is activated, auditory and visual monitoring are disabled. W5 High stimulator current and/or transcranial motor stimulation may cause involuntary patient movement resulting in patient injury. W6 High stimulator current and/or transcranial motor stimulation activating of the fth cranial nerve or Mastication muscles may cause

tongue lacerations.

W7 Do not use this instrument for either direct stimulation to, or direct recording from, the heart. Do not use for trans-thoracic stimulation;

maintain anode and cathode stimulating sites in close proximity.

W8 Direct stimulator contact may disrupt the operation of active implanted devices. Do not stimulate a patient with an implanted cardiac

pacemaker or similar implanted device without the approval of a licensed medical practitioner. W9 Do not use high level electrical or MEP stimulation to directly stimulate an exposed nerve. W10 High level electrical stimulators can produce outputs of 400V @ 100mA. Use electrodes with appropriate surface area to ensure safe

current densities. Do not use a needle electrode for patient ground. W11 Avoid prolonged use of high sound pressure levels or light intensity stimulation which may cause permanent hearing or visual

impairment. W12 LED goggles for ash stimulation should be used with closed eyes only. W13 False negative responses (failure to locate nerve) may result from:

• Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other).

• Inadequate stimulus current (too low or set to 0 mA).

• Inadequate current for stimulation of nerve through hardware, such as pedicle screws or stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve.

• Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.

• Inadvertent simultaneous current delivery from both Stimulator probe outputs. This may result in current shunting, division between the stimulator probes (this is referring to monopolar probes only).

• Flatline on the EMG channel caused by shorted internal amplier (characterized by baseline activity of < 3 µV p-p).

• Electrodes not positioned properly in the target muscles

• Non-ush contact between the stimulating electrode or probe and the nerve, inadequate stimulator probe electrical contact surface area, or high impedance.

• Stimulator return electrode is not connected, or other incomplete electrical connection between the NIM-Eclipse™ System, monitoring electrode and stimulator probe.

• Defective stimulating electrode or probe.

W14 Do not power-on the NIM-Eclipse™ System when the stimulator is in the surgical eld. W15 To avoid the risk of re or explosion, do not use the NIM-Eclipse™ System in the presence of ammable anesthetics and/or oxygen-rich

environments. W16 To avoid electrical shock, do not attach unapproved components or accessories to the NIM-Eclipse™ System. W17 Proper handling, insertion, and placement of electrodes and probes is critical for safe and accurate monitoring. W18 Improperly placed or bent needles increase the risk of needles breaking o in the patient. W19 Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needles to break o in patient. W20 Extreme care must be taken when handling instruments with sharp points or edges. W21 The surgical practitioner must choose the appropriate size and locations of electrodes and probes based on the procedure to be

performed and the stimulating current necessary for the application. W22 Reuse of single use electrodes and probes increases the risk of infection and may cause degraded or ineective monitoring. W23 After each procedure, properly clean and disinfect all reusable system components. W24 Disconnect power to the NIM-Eclipse™ System or connected printer before cleaning the unit to avoid electrical macro shock. W25 To avoid the risk of electric shock, connect the NIM-Eclipse™ System to hospital grade receptacles only. Achieve electrical grounding

reliability with proper connections. W26 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. W27 All service must be performed by Medtronic qualied service personnel only. Repair and/or modication to the NIM-Eclipse™ System or

any accessory by anyone other than Medtronic qualied service personnel may signicantly compromise the unit’s ability to monitor

nerve activity or expose hazardous voltages. W28 Use of any accessories, cables and disposables other than those specied or provided by Medtronic could result in compromised operation

such as but not limited to decreased accuracy, increased electromagnetic emissions, or decreased electromagnetic immunity of this

equipment. W29 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.

1-2 NIM-Eclipse™ E4 SD

Introduction

W30 Operation in close proximity to high frequency (shortwave or microwave) equipment may produce instability in the electrical stimulator

output. W31 Do not perform Magnetic Resonance Imaging (MRI) on a patient with electrodes, and probes in the eld. The eect of MRI is unknown on

these devices. W32 Do not touch non-medical equipment and patient simultaneously. W33 Special care must be exercised to distinguish between the high-pitched beep of the Event Tones (EMG activity over threshold), and the

dual-beep Stimulus Tone (indicates the set current is being delivered). W34 The NIM-Eclipse™ System is oered in both Laptop and Desktop versions. If the Desktop system is used, the Power Controller Unit must be

used with the system.

• Do not overload the Power Controller Unit by using it to control multiple systems. One Power Controller Unit is intended to be used with one system only.

• Do not connect any devices to the Power Controller Unit other than the NIM-Eclipse™ System for which its use is intended. The unit is not intended for use as a power source for devices that are not specically part of the NIM-Eclipse™ System.

• Do not place the Power Controller Unit on the oor when in use. The Power Controller Unit is intended to be used as a desktop/tabletop device.

• Proper handling, insertion, and placement of connections is critical for safe operation; consult the Setting Up Hardware section for more information.

• Do not use an extension cord with the Power Controller Unit; use only the system component line cords provided.

• The Power Controller Unit should be used away from heat emitting appliances such as heaters and radiators, etc.

• Do not use the unit in areas where there is excessive moisture or conductive contaminants present.

W35 The use of systems or components of other manufacturers in conjunction with the NIM-Eclipse™ System have not been veried. The

performance characteristics may be altered if systems or components of other manufacturers are used in conjunction with this device.

Precautions

P1 To avoid loud, extraneous monitoring noise during electrosurgical unit activation, ensure the ESU detection software is enabled or the

Muting Probe is properly attached to the active electrosurgical lead.

P2 To avoid false positive EMG events (stimulus artifacts):

• Ensure the recording electrodes and the stimulator (+) or (-) cabling are routed separately and not tangled.

• When possible, ensure the EMG ground is physically placed between the stimulator return electrode and the EMG channel input electrodes.

P3 Proper placement and setup of the electrosurgical unit away from the NIM-Eclipse™ System will reduce or minimize unnecessary muting

and interference. P4 Cables should be secured to the oor with tape or other non-trip device. P5 To avoid excessive muting:

• Avoid high-power electrosurgical unit monopolar settings. Note that muting caused by electrode charging may last several seconds after electrosurgical Instrument use.

• Avoid accidental contact between connected but unapplied electrodes and other conductive parts.

P6 Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard container in accordance with

hospital or other user facilities policy.

P7 This equipment is not liquid or splash proof. Erratic operation or permanent damage can result if water or liquids enter any of the

electronic portions of this equipment.

P8 Do not modify, change, alter or delete the software in this equipment. Third party software may interfere with proper operation of this

medical device. Do not install any o-the-shelf software without rst consulting Medtronic. Installing unapproved software may void the warranty.

P9 Automatic updates of Windows™* and Anti-Virus software have been disabled to prevent updating during a monitored procedure.

However the user will continue to be notied when software updates are available to be downloaded. Always install new updates as soon as is practically possible to ensure your system is current.

P10 Non-medical equipment approved to an appropriate standard (like IEC 60950) may be connected to the System I/O and auxiliary

mains output provided that the total leakage current meets the requirements of IEC 60601-1. If not, an IEC 60601-1 approved isolation transformer with appropriate ratings must be used. Consult Medtronic for additional details.

P11 To avoid system damage, do not connect any device other than NIM-Eclipse™ System accessories into the inputs on the rear panel of the

NIM-Eclipse™ System controller.

P12 Reasonable care should be made in making electrical connections and handling electrically powered devices. Do not use damaged

electrical equipment or frayed electrical cords.

P13 The NIM-Eclipse™ System operates from power sources of 50 to 60 Hz at 100/240 VAC. Use only hospital-grade power cords and the

connectors supplied with the NIM-Eclipse™ System. Be sure power cords and connectors are in good condition. Never apply a voltage to the equipment that is outside the range specied for its connectors.

P14 Connection of equipment not tested and or not found in conformance with the IEC60601-1 MEDICAL DEVICES AND APPLIANCES standards

is strictly prohibited.

1-3NIM-Eclipse™ E4 SD

Introduction

P15 Avoid accidental contact between connected but unapplied parts (devices which can be connected to the patient) and other conductive

parts including those connected to protective earth. P16 To avoid electrical and re hazard, use only recommended fuses. Fuses must match by type, voltage rating, and current rating. P17 To prevent overheating, keep ventilation holes free from obstruction. P18 Do not connect USB devices to the system while a test is running. P19 At the end of their life cycle, all NIM-Eclipse™ System electronic components must be sent to a WEEE recycling center or disposed of

according to local regulations. P20 The NIM-Eclipse™ System is not debrillator-proof. Remove all applied parts from the patient before applying the debrillator.

P21 Do not exceed the power rating of the NIM-Eclipse™ System Controller CPU Power Output (200VA). P22 Check the polarity and function before inserting peripheral connectors. Digital Preamplier Module and Stimulator connectors will mate

easily if alignment arrows line up. Damage will occur if excessive insertion force is used. P23 Medical electrical equipment including the NIM-Eclipse™ System may be aected by RF sources, such as radio or TV stations and portable

or mobile cellphones or communications devices. Consider RF sources when installing this equipment. P24 The NIM-Eclipse™ System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the

NIM-Eclipse™ System should be observed to verify normal operation in the conguration in which it will be used. P25 Once the user bends the probe, DO NOT attempt to straighten the probe again as damage will occur to the insulation.

Training requirements

This device is intended for use by physicians trained in the procedures described in the Indications for use.

Residual risks

Residual risks related to the use of the NIM-Eclipse™ System include: electrical shock, cardiac arrhythmia, cardiac arrest, bronchospasm, toxicity, nerve damage, nerve paralysis, nerve paresis, nerve fatigue, injury, infection, sepsis, additional exposure to anesthesia, and additional intervention needed to complete therapy.

Possible adverse events

In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.

Material composition

For material of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/ productstewardship.

1-4 NIM-Eclipse™ E4 SD

Section 2: Setting up Hardware

In this section, you will be able to:

1. Verify and identify system components

2. Install system components

3. Power on the system

Setting up Hardware

System components and software

The following components and software programs are available with the NIM-Eclipse™ System:

Computer NCCPUE4/NCCPUE4-DE/NCCPUE4-FR/NCCPUE4-IT/

Display monitor MON19/945MON19 CUSB100/945CUSB100 controller USB jumper cable, 0.5m Controller ECLC/945ECLC NIM-Eclipse™ System controller CPJ203/945CPJ203 power controller jumper cable, 0.9m Stimulators EEX901/945EEX901 electrical stimulator extender CPJ206/945CPJ206 power controller jumper cable, 1.8m

Digital preamplier module

Peripherals MDP201/945MDP201 ESU mute probe

Other P216/945P216 or P226 power controller (required for

NCCPUE4-ES/945NCCPUE4 laptop computer

NWCPUE4/NWCPUE4-DE/NWCPUE4-FR/NWCPUE4-IT/ NWCPUE4-ES/945NWCPUE4 desktop computer

AE102/945AE102 insert earphones CPC18/CPC19 UK/EU power cord, 6m VG202/945VG202 LED goggles CPC16/945CPC16 hospital grade power cord, 15ft DAQ916/945DAQ916 digital preamplier CPP500AUS/CPP50EUR/CPP50UK/CPP500IND printer

POC180/945POC180 pulse oximetry cable

desktop computer systems) TC32/945TC32 transporter case

Cables CDAQ916/945CDAQ916 preamplier cable

CEEX20/945CEEX20 stimulator cable, 6m CEEX98/945CEEX98 stimulator cable, 2.4m

CUSB6/945CUSB6 printer USB cable, 1.8m

power cord, 1.8m

System accessories

Disposable subdermal needle electrodes

Direct nerve probes BNP2001, CNP2001, CNP2002, FTP1001, MNP1001,

Pulse oximeter sensor

Note: The use of the Pulse Oximeter sensors with the NIM-Eclipse™ E4 System is not approved in Brazil or Canada.

Note: The use of the Direct nerve probes with the NIM-Eclipse™ E4 System is not approved for Speech Mapping and Motor Mapping Modalities in the European Union.

DSN1260, DSN1299, DSN2260, DSN2280, DSN2299 Electrode 945DSN1260, 945DSN1299, 945DSN2260, 945DSN2280,

945DSN2299

PSP1000, PSP1001, PSP1002, BNP2002, FTP2001, MNP2001, PSP2000, PSP2001, PSP2002

945BNP2001, 945CNP2001, 945FTP1001, 945MNP1001, 945PSP1000, 945PSP1001, 945BNP2002, 945CNP2002, 945FTP2001, 945MNP2001, 945PSP2000, 945PSP2001

PXC2002/945PXC2002 Stimulus

extenders

Surface electrodes

dissection instrument

Corkscrew electrodes

DSE0001, DSE0002, DSE0003, DSE0004, DSE0005 945DSE0001, 945DSE0002, 945DSE0003, 945DSE0004,

945DSE0005

DSE1115, DSE1125, DSE2115, DSE2125, DSE3115, DSE3125, DSE4115, DSE4125

945DSE1115, 945DSE1125, 945DSE2115, 945DSE2125, 945DSE3115, 945DSE3125, 945DSE4115, 945DSE4125

NSD2750, 945NSD2750

MEP1001, 945MEP1001

Unpack the system

When you unpack the NIM-Eclipse™ System, save the cartons and packing material in which your monitor arrived. If the instrument is to be shipped from one location to another, the custom designed shipping package will provide the best protection.

When the box is unpacked, check o the contents of the box against the items listed on the packing slip. If the contents are incomplete, or if there is damage, notify Medtronic. If the shipping container is damaged, or the cushioning material shows signs of stress, notify the carrier as well.

Shipping and storage environment

The items contained in this package can be stored or shipped within the following environmental limits. Note that these limits apply to nonoperational storage and shipping situations.

• Temperature -20°C to +60°C

• Humidity 15% to 95% (non-condensing)

• Atmospheric pressure 500kPa to 1060kPa

NIM-ECLIPSE™ E4 SD2-1

Setting up Hardware

System components descriptions

The main components of the NIM-Eclipse™ System neurological monitoring system consist of the NIM-Eclipse™ System controller, computer with installed NIM-Eclipse™ System software, Patient Interface Module (PIM), and optional stimulators.

NIM-Eclipse™ System controller

The ECLC/945ECLC NIM-Eclipse™ System controller provides high-speed digital data processing, stimulation generation and audio processing of EMG activity. The NIM-Eclipse™ System controller connects to the computer via the high-speed USB interface. The controller also supplies switched AC power to the computer.

Power indicator

Front panel indicator illuminates when the NIM-Eclipse™ System controller power is on.

Note: When power is switched on, there is a 2 to 3 second delay before power is applied.

Rear panel

The NIM-Eclipse™ System controller rear panel contains connectors for all optional peripheral components. Only Preamplier A, Electrical Stimulator Extender and the ESU probe connectors are used in the NIM-Eclipse™ SD system. Refer to the NIM-Eclipse™ System neurophysiologist supported (NS) Manual for details of the additional functions. The rear panel also contains the CPU USB interface, AC power input and output, main system power switch and fuse compartment.

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5 6

11 12 13 14 15 16 17

1. Preamplier A: Connect the OPM660/945OPM660 Patient Interface Module black color-coded connector to Preamplier A.

2. Preamplier B (not used)

3. Stimulator: Connect the OPM660/945OPM660 Patient Interface Module red color coded connector to Stimulator connector.

4. Earphones (not used)

5. LED Goggles (not used)

6. ESU Probe: Connect the MDP201/945MDP201 ESU Mute probe to this connector to provide audio muting and pausing of stimulation during electrocautery use.

7. USB Interface: Connect the NIM-Eclipse™ System controller to the computer USB port using the USB jumper cable.

8. Audio Input

9. Potential Equalization Terminal: The NIM-Eclipse™ System controller potential equalization terminal can be used to equalize ground potentials between instruments. Improper or inadequate power grounding can cause a potential dierence to exist between the NIM-Eclipse™ System controller chassis and earth ground, possibly resulting in line-related interference and artifact. Improper grounding is most often caused by faulty AC outlets. This potential dierence can be minimized or eliminated by connecting a heavy gauge wire from the Potential Equalization Terminal to a known high quality earth ground terminal.

10. CPU Power Out

11. External Triggered In

12. External Triggered Out 1

13. External Triggered Out 2

14. External EMG Speaker

15. Main Power Switch: Applies power to the controller and computer via the Computer Power Outlet. Power to the NIM-Eclipse™ System controller must be applied prior to login to Windows™*.

16. Fuse: The NIM-Eclipse™ System controller requires two (2) T2.5A250V Type 2 fuses.

17. AC Power In: Connect to AC power source. The NIM-Eclipse™ System operates from 105 – 240Vac, 50 – 60 Hz. Maximum input power is 300VA.

NIM-ECLIPSE™ E4 SD

2-2

Setting up Hardware

Patient Interface Module (PIM)

The Patient Interface Module (PIM), PN OPM660/945OPM660, provides the means for connecting the patient to the NIM-Eclipse™ System. The PIM contains the recording electrode amplier and electrical stimulator to connect to probes, MEP and TOF electrodes. The Patient Interface Module has inputs for one or two (left and right) pulse oximeters.

The PIM accepts recording electrodes from subdermal needle and surface electrodes. The PIM connects to the NIM-Eclipse™ System Controller via a two-connector, 20ft cable.

Note: The use of the Pulse Oximeter sensors with the NIM-Eclipse™ E4 System is not approved in Brazil or Canada.

PIM recording electrode inputs

Eight numbered and color-coded recording channels are provided grouped in two sets (left and right) of four channels. Electrode inputs of channels 1-4 are marked with a black outline to indicate left side electrode placement. Channels ve through eight are marked with white outline to indicate right side electrode placement. Color-coded electrode leads connect to their respective color-coded channels. Two electrodes per channel are required. Certain tests may require fewer than eight channels.

PIM stimulation panel

The NIM-Eclipse™ System provides stimulation suitable for peripheral, direct nerve and transcranial electrical motor evoked potentials (MEP). The stimulators are electrically isolated from the patient and the outputs are protected by both hardware and software fault detectors to ensure patient safety. Patient current is displayed for both constant current and constant voltage stimulation modes.

The PIM stimulation panel contains the connections for probes and for transcranial motor evoked potentials (MEP) and train of four (TOF) electrodes.

Probe outputs

These outputs connect to the Surgeon-Controlled Probe and electried instruments. In both cases, a return electrode must be connected from the Stim Return connector to the patient. The Stim Control and Instrument output polarity is negative (-) and the Stim Return reference polarity is positive (+).

The single use Surgeon-Controlled Probe with detachable tips allows remote adjustment of the stimulation current and control of the test through the user interface. The probe has two buttons for control, a multi-color LED indicator that provides test and status information and a buzzer for button press audio feedback.

Note: Surgeon-Controlled Probe stimulation is automatically halted when ESU is detected by the ESU Mute Probe.

NIM-ECLIPSE™ E4 SD2-3

Setting up Hardware

MEP Output

The MEP output is used to deliver high current, biphasic, transcranial electrical stimulation to elicit motor evoked potentials at selected muscle sites. MEP parameters are dened in the Modality Settings Panel & the Stimulus Settings Panel.

The MEP output connectors are specially keyed to accept only the MEP electrode. Open the online Setup Help feature to aid in the placement of electrodes.

TOF Output

TOF (Train of Four) output is used for peripheral nerve stimulation to evoke a compound motor action potentials (CMAPs) at the innervated muscle. The TOF test is used as a measure of muscle relaxation to non-depolarizing neuromuscular blockade agents. TOF outputs are polarized. Position the (-) negative surface electrode distal (closer to the innervated muscle) and the (+) positive surface electrode approximately 1-2 centimeters proximal to the (-) negative surface electrode.

Pulse Oximeter

The PIM will accept inputs from up to two (left and right) disposable pulse oximeter nger or toe sensors. The SD OPM accepts two Pulse Oximeter inputs. Each DPM only accepts a single Pulse Oximeter. When the pulse oximeters are used, oxygen saturation information is automatically measured and displayed. Oxygen saturation can be helpful to monitor for low blood ow in extremities due to eects of patient positioning.

Note: The use of the Pulse Oximeter sensor with the NIM-Eclipse™ E4 System is not approved in Brazil or Canada.

Electro-Surgery Unit mute probe

The MDP201/945MDP201 Electro-Surgery Unit (ESU) mute probe senses ESU activity and will stop stimulation and automatically mute the EMG speaker audio, preventing unwanted interference.

Note: When the ESU mute probe is used and electrocautery is detected, stimulus triggered traces will not be collected.

Clamp the ESU around only one output wire of the electrocautery and as close as possible to the interference generating device’s case. In some cases it may be necessary to loop the ESU wire around the probe twice. This technique will improve artifact detection. Connect the MDP201/945MDP201 cable connector to the controller rear panel connector labeled ESU Probe.

When both monopolar and bipolar electrosurgery units are used, and are located near each other, the mute probe can be connected to both as follows: Separate the bipolar ESU leads suciently and clamp the mute probe around one lead only close to the ESU enclosure. Open the mute probe clamp and place the monopolar ESU lead as described above.

Internal ESU detection sofware is available for use when you do not have access to the ESU mute probe. To access the internal ESU detection, open the speaker settings within any of the protocols to toggle the ESU detection.

Note: ESU detection is not a default setting and must be enabled prior to the start of cautery.

ELECTRO-SURGICAL UNIT

Return Electrode

89.5%

ESU Probe

Active Electrode

From ESU Active Electrode

To ECLIPSE Controller ESU Probe Input

NIM-Eclipse™ System computer

The NIM-Eclipse™ System is supplied with either a desktop or laptop computer with installed software. The computer provides user interface, data display, communications and output functions. The computer also interfaces with external devices, such as printers, LAN or remote monitoring features. The computer is supplied with all necessary software applications preloaded.

Consult the supplied computer’s hardware manual (included with the system) for the exact computer specications.

Power Controller Unit

The Power Controller Unit provides complete line isolation and surge suppression for protection of sensitive system components. Each Power Controller Unit provides electrical outlets congured to connect with the power cords provided with the NIM-Eclipse™ System components. The Power Controller Unit is used ONLY with the NIM-Eclipse™ System where the system uses the Desktop small form factor computer unit.

NIM-ECLIPSE™ E4 SD

2-4

Setting up Hardware

Connecting the system components

The NIM-Eclipse™ System is a highly sensitive instrument capable of detecting microvolt level physiological activity. Every precaution is taken in the instrument design to reduce extraneous and unwanted interference due to electrical noise (motors, uorescent lights, etc.) which may compromise data acquisition. This interference is characterized by an excessive line frequency signal present in the Live or Current Sweep display modes. Selection of a suitable installation site will minimize or eliminate this eect.

The back panel of the Main Console has a power ON/OFF switch. This switch may be kept in the ON position, and the entire system activated from the Power Controller Unit On/O switch.

Note: Power must be applied to the System controller prior to applying power to the computer. If power to the controller is interrupted, be sure to sequence power on as described.

Note: In the event the computer does not respond to keystrokes or mouse movements, press and hold the power button for 10 to 20 seconds to restart the system.

Connection guide

The NIM-Eclipse™ System has connectors on the rear panel to interface to the PIM, ESU mute probe, and other devices. Connect the patient related peripherals as required for your application as shown in the diagram below. An optional mouse may be connected to the NIM-Eclipse™ System via the computer USB ports. To connect an optional printer to a laptop NIM-Eclipse™ System, a wireless connection such as Bluetooth™* or WiFi™* must be used. If a desktop system is used, the optional printer may be connected via USB.

If a desktop computer is used instead of a notebook computer as shown, plug the Power Controller Unit into the Hospital Grade Receptacle, then plug the NIM-Eclipse™ System components; including printer, monitor, and other similar connected accessories; into the Power Controller Unit. Only the Power Controller Unit should be connected to a Hospital Grade Receptacle as it provides electrical isolation to the equipment. Do not bypass the Power Controller Unit by plugging these accessories directly into a wall outlet.

Patient Interface Module connection

The PIM is connected to the Controller via a twenty-foot dual cable, enabling you to place the Controller at some distance from the patient. Connect the PIM interface cable connectors to the Preamplier “A” and Stimulator connectors of the NIM-Eclipse™ System Controller.

SD SYSTEM CONNECTION DIAGRAM

Notebook Computer

Notebook Computer Supply

NIM-Eclipse™ Controller

Mouse

ESU Probe

Patient Module

To Hospital Grade Receptacle

NIM-ECLIPSE™ E4 SD2-5

Setting up Hardware

Powering on the system

Once all connections have been made:

1. Plug the NIM-Eclipse™ System controller into a hospital grade receptacle or the Power Controller Unit that has been plugged into a hospital grade receptacle. Ensure the NIM-Eclipse™ System is positioned so it can be easily disconnected from the hospital grade receptacle, if necessary. Note: If using a desktop computer with Power Controller Unit, turn the Power Controller Unit on by placing the switch in the I position.

2. Press the NIM-Eclipse™ System controller rear panel power switch button.

3. After ve seconds, press the power button on the computer.

Patient Interface Self-Test

The PIM recording and electrical stimulator sections are tested for proper operation during start-up. If, for some reason, the PIM fails the self-test procedure an error message will be displayed.

In most cases, this error is caused by a faulty connection or an electrical disturbance. When the error message occurs, check the connections or replace the PIM or cable. Click Reconnect to return to the screen. If the problem persists, contact Medtronic.

NIM-ECLIPSE™ E4 SD

2-6

Section 3: Quick Start and Stop

In this section, you will be able to:

1. Use the NIM-Eclipse™ System on a basic level.

2. Stop the NIM-Eclipse™ System.

Quick Start and Stop

Quick start procedure

The following are instructions to quickly get up and running with the NIM-Eclipse™ System. These instructions are very general and represent only the basics of operating the system. We encourage you to read the manual thoroughly to make full use of the exibility and power of the NIM-Eclipse™ System.

To get started with the NIM-Eclipse™ System:

1. Connect the system as described in the Setting Up Hardware section.

2. Power on the Controller.

3. Power on the Computer.

4. Conrm the Operator name on the NIM-Eclipse™ System splash screen, then click [SD].

5. Click [Run Test]. Select the appropriate protocol from the protocol list and click [Run], or, double-click on the selected protocol. Note: Default protocols are provided as examples of the systems capabilities. Do not use default protocols without prior conrmation that

they are applicable for the intended procedure.

6. In the Select Patient window, select Existing Patient, New Patient or Unnamed based on case needs, then click [OK].

7. In the Congure Channels window, rename the electrode channels, if desired.

8. Connect the recording electrodes, Surgeon-Controlled Probe and stimulus return electrode to the Patient Interface Module.

9. Click [OK] to start monitoring.

10. Adjust stimulation as needed.

Monitoring Options

• When applicable, change Sensitivity and Sweep Length for improved signal display.

• Use the Modality Settings Panel to adjust Test Parameters.

• Use the Comments feature to enter comments, as necessary.

• Press the Print button to print a summary report.

• Press the Screenshot icon to quickly save a snapshot of the screen.

Quick stop procedure

The following are instructions to quickly stop and shut down the NIM-Eclipse™ System.

1. Click the Stop All icon on the NIM-Eclipse™ System screen or F2 on the keyboard to stop recording and stimulation for all started modalities.

2. Click the System Menu icon on screen and select Close to close the protocol.

3. Click the System Menu icon on screen and select Exit to close the system.

4. Click the Windows™* Start menu and select Shut Down to turn o the computer.

5. Turn o the power of the NIM-Eclipse™ System controller.

6. Turn o the NIM-Eclipse™ System Power Controller Unit (desktop version only).

3-1 NIM-Eclipse™ E4 SD

Section 4: Creating and Modifying Protocols

In this section, you will be able to:

1. Understand NIM-Eclipse™ System screens

2. Use the Patient Information Panel

3. Use the System Settings Panel

4. Understand Congure Channels

5. Create a Protocol

6. Modify a Protocol

7. Use the Modalities Settings Panel

8. Use the Stimulus Settings Panel

9. Use the Secondary Windows™* Settings Panel

10. Use the Speaker Settings Panel

11. Use the Comments Settings Panel

Creating and Modifying Protocols

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NIM-Eclipse™ System Run/Modify Test selection screen

The NIM-Eclipse™ System Run/Modify Test Selection screen contains protocol tabs and Medtronic and user-dened protocol lists.

1. System Menu: Use this menu to access System Info, Setup Help, Help, User’s Manual, Support, and Exit the system.

2. Protocol tabs: Displays the protocol list by protocol type.

3. Refresh (or F5 key): Click to refresh the protocol list.

4. Minimize: Click to minimize window.

5. Maximize: Click to maximize window.

6. Close: Click to close the application.

7. System Settings: Allows users to change the general settings for the overall system.

8. Show/Hide settings panel: Shows/Hides settings and chat.

9. Resize window: Drag to resize the window display.

12. Remote View: Allows users to enable remote networking.

13. Review Test: Shows list of saved procedures available for review.

14. Resume Test: Allows users to resume a test/procedure.

15. Run Test: Allows users to select/run protocols from a list of saved protocols.

16. Run/Modify: Click to run/modify the selected protocol.

17. USERS: Toggle between Medtronic and user-dened protocols.

18. Protocol list: Displays the list of saved protocols, their related modalities, the date and time when the protocol was last saved, and any notes. Select a protocol by clicking on it. A quick doubleclick will select and run the protocol.

10. Modify Protocol: Allows users to modify protocols from a list of saved protocols.

11. New Protocol: Allows users to create/save new protocols.

4-1 NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

NIM-Eclipse™ System Resume/Review Test selection screen

The NIM-Eclipse™ System Resume Test screen displays a list of recently run tests. The NIM-Eclipse™ System Review Test screen displays the patient test inside the selected folder. Right-click the column headers to show/hide columns.

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3 4 5 6

7 8

1. System Menu: Use this menu to access System Info, Setup Help, Help, User’s Manual, Support, and Exit the system.

2. Folder path and Folder icon: Displays the address of the selected test. Click the icon to open the browser to select a test.

3. Refresh (or F5 key): Click to refresh the screen.

4. Minimize: Click to minimize window.

5. Maximize: Click to maximize window.

6. Close: Click to close the application.

7. Patient and Case Information: Displays a series of panels that enables users to complete case information including Personal, Case Sta, and Case Info.

8. System Settings: Allows users to change the general settings for the overall system.

9. Show/Hide settings panel: Shows/Hides settings and chat.

10. Resize window: Drag to resize the window display.

11. Modify Protocol: Allows users to modify protocols from a list of saved protocols.

12. New Protocol: Allows users to create/save new protocols.

13. Remote View: Allows users to enable remote networking.

14. Review Test: Shows list of saved procedures available for review.

15. Resume Test: Allows users to resume a test/procedure.

16. Run Test: Allows users to select/run protocols from a list of saved protocols.

17. Resume/Review: Click to resume/review the selected test.

18. Patient list: Displays the list of patients, the date and time when the protocol was last saved. Right-click a test and select from the available options. Right-click the header line to select which columns are visible.

4-2NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Create a protocol

The New Protocol feature enables users to create and save new protocols.

1. Click [New Protocol] on the Main screen.

2. On the Electrodes screen, congure channels.

3. Use Modalities Settings to congure parameters for the modalities to be included in the protocol. Refer to the Modality Settings topic for more information.

4. Click File Menu > Save As to save the protocol.

5. Select Save As and navigate to the user sub-folder location where the protocol will be saved.

6. Name the Protocol, then click Save.

Modify a protocol

The Modify Protocol feature enables users to modify and save existing protocols. The window is divided into Protocol Name, Modalities, Date and Time, and Notes columns. To modify a protocol, click [Modify Protocol] on the Main screen.

• Users: These folders are used to store Medtronic preset protocols and user created protocols. Right-click on a folder to add, rename, or

remove the folder.

• Protocol Tabs: Protocol tabs organize available protocols into categories. The system includes one default tab, Spinal. Right-click on a tab to

add a new category or rename or remove existing categories.

• Protocol List: The Protocol List displays all standard Medtronic (read only) and user dened test protocols. Test protocols are further

subdivided by the protocol tabs at the top of the screen. Right-click over a protocol name and select from the displayed menu one of the available functions. Multiple protocols can be selected for simultaneous Export and Delete. Right-click the header line to import protocols.

• Read only: Factory Preset protocols are read only, but may be modied and saved with a new name.

• User dened: User dened tests are created either directly or indirectly by modifying and renaming a factory preset test.

To modify a protocol:

1. On the Main screen, locate the appropriate protocol in either the Medtronic or User folders and within the protocol tabs.

2. Highlight the desired protocol and click [Modify], or double click the desired test protocol.

3. Use Modalities Settings to congure parameters for the modalities to be included in the protocol. Refer to the Modality Settings topic for more information.

4. Click File Menu > Save to save the protocol.

5. Select Save As and navigate to the user sub-folder location where the protocol will be saved.

6. Name the Protocol, then click Save.

Run a test

The Run Test screen contains a list of factory preset and user-dened test protocols. The window is divided into Protocol Name, Modalities, Date and Time, and Notes columns. To run a test, click [Run Test] on the Main screen and do the following:

1. Locate the appropriate protocol in either the Medtronic or User folders and within the protocol tabs.

2. Highlight the desired protocol and click [Run], or double click the desired test protocol.

3. In the Select Patient window, choose an existing patient or enter the name and ID number of a new patient.

• Select an existing patient’s information to add to the Case. When selecting an existing patient, the patient’s information populates in the

Patient and Case info Panel on the monitoring screen.

• Provide new patient information. In the Select Patient window, type the patient’s rst name, last name, and ID number. Patient

information for this new patient can be modied in the Patient Information Panel on the monitoring screen.

• Select an Unnamed Patient. When selecting an unnamed patient in the Select patient window, patient information can be modied in

the Patient Information Panel on the monitoring screen.

4. Click [Ok].

Start/Stop

Press the Start/Stop button on the modality window title bar to start/stop recording and stimulation.

4-3 NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Run test functional keys

Use the following functional keys on the keyboard to perform NIM-Eclipse™ System functions while running a test.

Key Run Test

F1 Help F2 N/A F3 N/A (Use Shift+F3 in simulation mode to simulate

F4 Electrodes F5 N/A F6 N/A F7 N/A F8 N/A F9 Save screen F10 Print screen F11 Speaker On/O

measured current)

Resume a test

From the Main screen, users can resume test from the last saved point. The user can resume a test as long as the period of time between starting and resuming a test doesn’t exceed 7 days. The resume test screen contains the following sections:

• Patient Name: Field contains the patient name.

• ID: Field lists the ID number associated with the patient.

• Protocol: Field lists the name of the Protocol.

• Date and Time: Field lists the date and time the protocol was created.

• Folder: Field contains the folder name for the patient or patient data. Right-click over the header line of the list to show/hide the folder.

To resume a test:

1. Click [Resume Test] on the NIM-Eclipse™ System Main screen.

2. Select the patient test to be resumed.

3. Click Resume.

4. Click Yes to reset all stimulus Intensities to zero, or No to retain stimulus intensity settings.

Resume a test after accidental power loss

The following are instructions to resume a test after accidental power loss:

1. Turn on the computer, if it is not rebooted automatically.

2. Launch the NIM-Eclipse™ System application.

3. Follow the Resume a test procedure above to continue. Note: Select Yes to reset all stimulus intensities to zero during Resume a test.

4-4NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Patient Information

The Patient Information panel enables users to enter data about the case. Access the Patient Information panel from the NIM-Eclipse™ System Resume or Review screen by clicking the Patient Information icon.

There are several sections in the Patient Information Tab. Each of these sections contains a series of text entry elds and lists for data entry.

Personal

The Personal section contains information elds specic to the patient such as vital statistics, patient’s address, and notes.

Case Sta

The Case Sta section contains information elds used to list the individuals involved in the case such as the surgeons, anesthesiologists, technicians, and hospital.

4-5 NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Case Info

The Case Info section contains elds used to list information about the case such as the diagnosis, procedure, muscle sites, anesthesia, and surgery start and end time. The system automatically lls the Monitoring Start and End elds when the user starts/stops a modality.

Case Details

The Case Details section contains elds for history, pre- and postoperative neuro decit.

Monitored Modalities, Alerts, Alarms

When the user starts a modality, the system automatically marks it as a monitored one. The system shows Numbers of Alerts and Alarms per

modality. Click the Details icon (3 dots) to review or modify these events.

4-6NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Create a Patient Prole

1. Click [Review Test].

2. Click the Patient and Case Information icon.

3. Click + in the Patient Information panel.

4. In the New Patient window, type the patient’s name and ID number in the elds.

5. Press [OK].

Modify a Patient Prole

1. Click [Review Test].

2. Select the patient from the list.

3. Click the Patient and Case Information icon.

4. Modify patient information in the Personal, Case Sta, Case Info, Case Details 1, and Case Details 2 sections of the Patient Information panel.

Delete a Patient Prole

1. Click [Review Test].

2. Select the patient from the list.

3. Click the Patient and Case Information icon.

4. Click [ in the Patient Information panel.

5. In the Delete Patient Data window, click [OK] to delete the selected patient’s data.

Alternatively, to delete a patient prole:

1. In the review test screen, right-click the patient test and select Delete.

2. In the Delete Patient Data window, click [OK] to delete the selected patient’s data.

Edit Lists

Users can edit preset items in the Patient Information panel by using the List Editor feature. Refer to the “Report Generator” topic for a description of how to edit lists.

To open the list editor:

1. Click the Patient and Case Information icon.

2. Click either Case Sta or Case Info to reveal the Edit List button.

3. Click [Edit Lists] button.

4-7 NIM-ECLIPSE™ E4 SD

System Settings

The System Settings panel controls the look and feel of the NIM-Eclipse™ System. On the panel, the user can congure General settings as described below.

General tab

• The Language setting enables users to select the language that the system displays.

• The Units settings enable users to select what units the system uses.

• The Amplitude Decrease warning setting enables the user to enter the percentage drop of the response amplitude when the system displays a warning. If the user enters zero, it disables the warning.

• The Latency Increase warning setting enables the user to enter the increase in percentage when the system displays a warning. If the user enters zero, it disables the warning. The system only displays the MEP latency warning if the peak-to-peak amplitude is above or equal to the Threshold level.

• The Auto Switch EMG Modality switches from Triggered EMG to Raw EMG if the measured current is 0 for 10 seconds. The Auto Switch EMG modality switches from Raw EMG to Triggered EMG if the measured current is not 0.

• The SD Advanced Mode enables more modality and stimulus settings to be adjusted by the users. Additionally, this setting enables the thumbnail tray.

• ESU software detection enables the software to detect the ESU, mute the audio, and stop the stimulation. To work reliably, connect the recording electrodes for all EMG channels to the patient.

• The ESU software detection algorithm uses the Detection Level setting. Adjust the level to work appropriately with your ESU devices.

• The Notch Frequency setting enables users to select either 50 or 60 Hz for the notch frequency.

• When the user checks [Create research le], the system creates/updates the le for the case every time the user changes a eld used in the research le while in the main screen, or when the user closes run/review. The system does not create the le for tests saved with 4.3.423 or earlier versions. The system uses the patient encrypted name and data folder name for the le name. Also, the system creates two other les: the “Res_Header.cvs” le with column headers for the research data les and the “Res_Lists.cvs” le with the list items used for the elds in the research le. The [Folder Name] selects where to create the le. [Combine all research les] creates the “Res_Data.cvs” le. If the user checks [Include header in the combined le], the system puts the header line in that le.

• When the user checks [Enable export of current sweeps], the system exports individual EP sweeps for the D Wave modality while the [Current Sweep (Live)] is checked. The system places les with exported data in the test data folder.

• The Show on Status Bar list enables users to select what displays on the status bar.

• The Thumbnail Size slider controls the width of the trace and other thumbnails when minimized.

• Pen width controls the width of the displayed traces.

Creating and Modifying Protocols

4-8NIM-ECLIPSE™ E4 SD

Creating and Modifying Protocols

Colors tab

• The Color Mode setting enables users to select Black, White, Custom, and Printer color modes. Each color mode provides a default palette of colors that the system uses to display information.

• The Set Default setting resets all changes made to the color palette.

• The colors for the selected color mode are organized in two groups; Common Colors group and EEG/EMG Channels group.

• The system assigns the Selected Color to a color setting when the user clicks on that setting. Select a color from the list, or press [Advanced] to select a color from the palette. Click anywhere in the screen to close the Selected Color list.

• If the user checks the Display Captured box and there are captured traces, the system uses channel colors for the captured traces. The system uses the EMG Response color for the raw traces.

Training tab

• The Training settings enable the system to simulate data for dierent modalities and situations and display the data while running a test.

• The system controls the Training settings from the same computer where the test is running, or from a dierent computer. Both programs must create the same Simulated Data Folder.

• The Training tab is always available in the System Settings main screen and during a run test, modify test, and new protocol in simulation mode. When in run mode, the only settings available are the Simulated Data Folder and Anesthesia Agents settings.

• Use the Open Waveform Simulator setting to generate data for the modalities. Click on any Waveform or Ampl Change window to change its shape.

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Congure Channels

Verifying Impedances

The Congure Channels window enables you to dene channels. The window provides a visual representation of the Patient Interface Module. Eight boxes representing the eight available channels display electrode information. Visual representations of the Ground, Stimulation control and return, Instrument, and both positive and negative impedances for MEP and TOF modalities are also provided in the channel menu.

During the test, electrodes are continuously monitored. If an electrode lead fails or if its impedance becomes too high to provide accurate monitoring a warning message will be displayed. Insure electrode impedances are lower than 5K Ohms and attempt to match impedances of each channel to less than 2K Ohms.

Each electrode is measured independently, however at least 3 electrodes, including the Patient Ground electrode must be connected to obtain accurate readings.

Proper application of recording electrodes is essential for accurate monitoring and reduction of power line related interference. Power line interference appears as a 50/60 Hz, or multiples of 50/60 Hz, periodic waveform “riding” on the trace. It can be caused by either electrostatic or electromagnetic induction from the power line to the patient or instrument. Reducing or balancing electrode impedance or moving the patient position relative to the equipment or changing the site may reduce this artifact.

Selecting a Channel Mode

When the D Wave modality is enabled, each channel can be turned o, selected as an EMG channel, or selected as a D Wave channel. To change the mode select the button that matches the channels color.

The system enables the [OK] button when a test is running and all recording channels used for the test are green. Green channels indicate the impedances are in the proper range. If a channel is not green, this indicates the channel has high impedance. If the channel cannot be xed, click on the checkmark next to the channel mode button to disable the channel and allow the test to continue.

Setting a Channel On/O

The user can enable/disable a channel by using the checkmark next to the channel mode button. If all channels for are o, the system stops all modalities except the Trig EMG. This setting enables the user to use the Trig EMG for stimulation

without recording.

Naming Channels

1. Click the channel descriptor located at the bottom the monitoring screen. Each colored channel has a corresponding text box containing the channel name.

2. Name the channel by typing the name of each channel in the text eld.

3. Click [OK].

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Raw EMG Modality

The Raw EMG modality displays the EMG signal responses in real time. If the user enables Captured Responses, the system captures responses when the signal exceeds the response amplitude. The system displays the captured responses above the trace in the trace window. The captured response remains displayed until the signal again exceeds the threshold. If the user enables the EMG Audio Tone for Raw EMG, the user hears a beep tone when the signal exceeds the threshold.

Triggered EMG Responses

Triggered responses are derived from EMG traces. Triggered EMG captures a segment of an EMG trace, occurring after a stimulus or threshold trigger. If the user checks [Captured Responses] and there are captured traces, the system uses channel colors for the captured traces. The system uses the EMG Response color for the raw traces. The captured response will remain displayed until the next Triggered response exceeds the preset threshold or the Clear button is pressed. The peak-to-peak amplitude of both the stimulus Triggered and captured responses are displayed. If EMG Audio Tone is enabled for Triggered EMG, a beep tone will be heard whenever the Triggered response exceeds the threshold. The system switches the modality from Triggered EMG to Raw EMG after ten seconds, if enabled. Select [Freeze] to stop updating the window while the system collects data.

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Neural Proximity Test Mode

The Neural Proximity Test Mode is designed to provide feedback to indicate proximity to a nerve root during the early portions of the surgical procedure. The surgical instrument is connected to the Stim Control or Instrument output of the Patient Interface Module and is electried. The program automatically changes stimulation intensity applied to the instrument while searching for an EMG response.

The test begins immediately when the Neural Proximity test mode is selected. Stimulation is applied automatically and EMG responses to stimulation are monitored with parameters previously dened. Responses found at lower stimulation intensities indicate the nerve is closer to the instrument site.

Audio feedback provides the indication of nerve proximity. High and low frequency tones indicate a nerve near or more distance to the electried instrument site respectively. Three dierent tone frequencies are used to indicate the stimulus current intensity needed to evoke an EMG response. Tone Threshold Low and Tone Threshold High parameters dene the intensity levels at which the audio tone changes. When the stimulus intensity decreases, the tone duration and the interval between the tones also decreases. When the measured stimulation intensity is zero. If enabled, the user hears an EMG tone when EMG activity has amplitudes greater than the preset Raw EMG threshold. Audible EMG is not available.

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Pedicle Screw Integrity Test

The Pedicle Screw Integrity Test is designed to quickly and automatically verify proper positioning of pedicle screws during spinal xation procedures. The Pedicle Screw Integrity mode combines automatic electrical stimulation and EMG response analysis to speed testing of screw placement. Stimulus parameters and response criteria are adjustable. The Pedicle Screw Integrity test provides the user with voice or tone status indicators and ability to stop the test after the rst response is found or to continue the test until the End Intensity is reached.

The Surgeon-Controlled Probe is used to contact and stimulate the screw. When the test starts, the stimulus intensity is applied at the Start Intensity value. For each stimulus intensity, the EMG amplitude at the selected muscle sites is measured and tested against the response criteria. If a response is not found, the stimulus intensity is increased. When the response criteria for a trace are met three consecutive times at the same stimulus intensity, a valid response has been found. The response is then tested against the Pass/Fail Criteria and the result displayed and saved.

The Pass/Fail criteria can be based on responses meeting absolute stimulus intensities or based on intensity levels required to elicit a response when the corresponding nerve root has been tested.

In the SD Advanced Mode, the “Stop After First Response” check box can be accessed in the Stimulus Parameters under the Pedicle Screw section of the Stimulus Settings. If the box is checked, the auto test procedure will stop when the rst response is found. If a response cannot be elicited or the control is not checked the procedure continues until the End stimulus intensity is reached.

When the test ends, the result will be saved for each spinal level tested as a comment for later review. The end-of-test comment indicates the level tested and test result: Pass, Fail or No Decision. The comment will also display the trace names and stimulus intensities (mA) when a response was found. Comments are displayed with a green, red or yellow background for Pass, Fail or No Decision, respectively. Use two dierent stimuli for dierent pedicle levels.

Enabling the pedicle screw audio will prompt the NIM-Eclipse™ System to silence the EMG audio during the pedicle screw testing phase. Once the pedicle screw testing is complete, the system automatically adjusts the EMG audio.

Nerve Root Test

The Nerve Root Test is used to locate and quantify the health of a nerve root. Results of the Nerve Root test are saved and can be used as a reference when performing the Pedicle Screw Integrity Test. The Nerve Root test relies on direct stimulation of the nerve root and combines automatic electrical stimulation and EMG responses to quantify results. Stimulus parameters and response criteria are adjustable.

The Surgeon-Controlled Probe is used to contact and stimulate the nerve root. When the test starts, the stimulus intensity is applied at the Start Intensity value. For each stimulus intensity, the EMG amplitude at the selected muscle sites is measured and tested against the response criteria. If a response is not found, the stimulus intensity is increased. When the response criteria for an EMG trace is met, a valid response has been found and the test ends. If a response cannot be found, the test will stop when the predened End stimulus intensity is reached.

When the test ends, the stimulus intensity required to elicit an EMG response for the corresponding nerve root will be saved for each spinal level tested.

The Spine View displays the spinal segmental levels to be tested. The test results are displayed on the appropriate vertebral level selected. Press a spinal level with probe button 1 to begin the test.

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Train of Four (TOF)

Train of Four uses peripheral stimulation of the ulnar nerve at the wrist and the peroneal nerve at the bular head. Single channel EMG responses are recorded from abductor digiti minimi and anterior tibialis muscles, respectively. The ratio of the height of the fourth response to the rst has been dened as the train of four ratio. The height of the response is measured as the dierence in amplitude from the largest peak to the following trough. In the absence of nondepolarizing block, the T4/T1 ratio is approximately one.

TOF is an automatic test that rst determines the stimulation intensity required to achieve a maximal muscular response. During the rst or calibration phase, the stimulation applied is a single pulse repeated twice per second. The stimulation increases in intensity until the recorded compound motor action potential (CMAP) in the innervated muscle reaches a maximum. TOF cannot be repeated until 12 seconds have passed since the last TOF stimulation.

TOF Stimulation Artifacts

Stimulus artifact may obscure the TOF responses or provide incorrect measurements, especially when the stimulation and recording electrodes are in close proximity. To reduce the eects of stimulus artifact:

• Prep the skin with abrasive prior to applying stimulation or recording surface electrodes.

• Do not place the proximal stimulation electrode closer than 2, preferably 3, inches from the recording electrode.

• Place the stimulation electrode centers no further than 1 inch apart.

• Use small, 15mm x 20 mm surface area stimulation electrodes.

• Use biphasic stimulation.

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Graph

The TOF graphic is a bar graph representation of the peak-to-peak amplitudes of each EMG response to the stimulus. The rst bar is colored red and represents the amplitude of the EMG response during the calibration phase. This is the T0 reference response. The second group of yellow bars represents the amplitude responses to each stimulus in the train of four. The rst bar in the group is T1 and the last T4.

The TOF ratio is displayed to the right. When the amplitude of the T4 response is less than 20% of the T1 response, the TOF ratio is not displayed but is replaced by the remaining number of twitches.

Responses

TOF responses are EMG compound motor action potentials (CMAP) in response to each stimulus in the TOF stimulation pattern. The responses are displayed shifted and superimposed. The maximum peak-to-peak amplitude of each response is measured and the T4/T1 ratio is calculated. The scale is automatically calculated and displayed on the lower right. The time base is xed at 10ms/div and displayed on the lower left.

TOF responses are scaled automatically and are based on the higher of the baseline calibration and rst response in the TOF train. The CMAP peak-to-peak amplitude must be above the threshold to be considered a valid response.

Motor Evoked Potential (MEP)

The MEP test mode is used to test spinal cord motor pathways. Transcranial electrical stimulation is applied over the scalp motor cortex using two spiral electrodes. A constant voltage, fast or slow charge, biphasic train of pulses is used at selectable intensities to elicit an EMG response. Single train and double train stimulation modes are available. Recording electrodes are placed at muscle locations corresponding to the spinal levels at risk during the surgical procedure. The stimulus is triggered and responses are recorded and displayed for analysis. Single and dual beep tones indicate the stimulator has been armed and triggered, respectively.

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D WAVE

The D Wave modality is used to test the motor pathways of the spinal cord. Transcranial electrical stimulation is applied on the scalp over the motor cortex. The D Wave response is recorded from the epidural space of the spinal cord with the use of an epidural catheter electrode. D Wave is recorded from selected channels dierent from the EMG channels.

Speech Mapping

The Speech Mapping modality is used to nd the speech related areas of the brain. The stimulation is applied for a selected period of time, there is no recording.

When starting the Speech Mapping modality, the stimulator becomes active at 0.5mA. Select the delivered current amount. When the stimulator comes into contact with the tissue it delivers this amount for a selected amount of time (default is 4 seconds). After the selected duration has elapsed, the delivered current amount will stop and return to 0.5mA. To initiate another stimulation, the stimulator tip must break contact with the tissue to prime the instrument for the next stimulation. If the Speech Mapping Audio Tones checkbox is enabled, tones will alert the user when stimulation is initiated by contact with tissue, when stimulation ceases, if the instrument breaks contact with the tissue, or if the selected time has elapsed.

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Motor Mapping

The Motor Mapping modality is used to nd the motor related areas of the brain recorded from the EMG channels. Click [Freeze] to stop updating the window while the system collects data.

Modality Settings

The Modality Settings panel contains all parameters for adding/removing modalities and modifying the recording and displaying settings. The Modality Settings panel is divided into the following sections; Trace, Stack, Spectral, Numeric, and Markers.

• Modalities can be added at any time while creating a protocol or running a test.

• Modalities can be removed at any time during creation of a protocol.

• When opening a protocol, modalities cannot be removed after any test has started.

To add modalities:

1. Click the modality button [+] at the top of the Modality Settings panel.

2. Select the check box for each modality to be added.

3. Click on each modality tab, then click the down arrow icon in the Modality Settings panel to reveal modality settings. Note: Press the down arrow icon on the right side of the panel to reveal additional modality settings. On the Congure Channels window, complete the elds as necessary, then click [OK].

To remove modalities:

1. Click the remove modality button [-] at the top of the Modality Settings panel.

2. Uncheck the box for each modality to be removed, then click [Apply].

Trace Panel

The Trace Panel provides controls for the display of the modality traces used during a procedure. The available settings for each modality vary; the system only displays the settings available for the selected modality.

Note: Some settings are only available when the system is in SD Advanced Mode.

Trace Settings Field Trace Settings Field Description

Channel Use this eld to select a channel. The additional Trace settings that appear apply to the selected channel. Apply to all Select this eld to apply settings changes to all channels. Sensitivity This eld species the sensitivity to be used in the display. Use the Up and Down keys to change the sensitivity on the

Trace or Stack windows.

Response Level [μV] Use this eld to set response threshold value for Raw EMG modality. Only EMG signals exceeding this threshold will be

considered as a response and will be captured.

Captured Responses Use this eld to indicate that the system should capture and display responses for review when they exceed the

threshold amplitude if the setting is enabled. This setting is only available for the Raw EMG and Triggered EMG modalities.

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Trace Settings Field Trace Settings Field Description

Artifact Rejection Select this eld to enable/disable artifact rejection acceptance limits for data. When a reading exceeds the artifact

limits, it will be rejected as invalid and not processed. Select the artifact rejection limit in the Level [V] eld. The system mutes the Raw EMG if the signal is above the artifact level.

Threshold Line Current Sweep (Live)

Select this eld to show/hide the threshold lines in the trace window. Drag these lines to adjust the response or artifact levels. Select the threshold level in the Level [V] eld. The system displays the current sweep instead of the building average when the user selects current sweep in the EP modalities.

Start [ms] Use this eld to set a time delay after the start of the stimulus, so that the checking for a response or artifact rejection

may begin at some time after the stimulation. This feature is useful in the event of a high amplitude stimulus artifact. Level [μV] Use this eld to set the threshold level or artifact rejection limits. Display Use this section to enable/disable items on the trace display. The following items are available.

Captured Responses Auto Sensitivity Baseline

Peak to Peak Ampl AUC AUC Baseline

Replication Number Time Time Baseline

Max Response Stimulus Information Time Captured

Best Channel Filters Use the lters settings to optimize the signal to noise ratio of the desired signal.

LFF [Hz] Low frequency lter, denes the high pass frequency in Hz. The LFF setting allows for

frequencies below the dened frequency to be removed by the lter.

HFF [Hz] High frequency lter, denes the low pass frequency in Hz. The HFF setting allows for

frequencies above the set frequency to be removed by the lter.

Notch Select this eld to enable/disable the line rejection lter which removes power line

related interference. Sweep Length [ms] Use this eld to set the sweep length in milliseconds. Sweep length denes the total analysis time for the data. Shifted Oset [%] Use this eld to set the percentage oset for each trace in TOF trace window. Split Use this eld to select the orientation of the split trace display. Less Replications Use this eld to set the max number of replications to be displayed when Less Replications is selected. More Replications Use this eld to set the max number of replications to be displayed when More Replications is selected. Replications per

division Ignore when

Use this eld to set the vertical space between the displayed replications. The number of vertical divisions occupied by each channel will depend on this setting and the number of the displayed replications.

If the user checks this eld, the system does not collect traces when the measured current is 0. measured current is 0

Note: The system shows the Peak-to-Peak Ampl value on replications as a percentage change to the baseline value if the system shows the baselines. The system shows the AUC value on replications as a percentage change to the baseline value if the system shows baselines and baseline AUC.

Stack Settings

The stacked mode displays sweeps stacked in time and is a convenient way to show response history. The most recent trace is shown at the bottom of the stack. The user can open the Stack settings panel by left-clicking on a channel name in the Stack window.

Note: Raw EMG is not a settings option in Stack Settings.

Stack Settings Field Stack Settings Field Description

Channel Use this eld to select a channel. The additional Stack settings that appear apply to the selected channel. Open/Close the

Select this eld to place the window on the top in the thumbnail tray. Modality

Stack Window Apply to all Select this eld to apply settings changes to all channels. Sensitivity This eld species the sensitivity to be used in the display. Space Use this eld to dene the amount of space between each trace in the stack.

X Shifted Oset Percent of one horizontal division, maximum of 250.

Y Shifted Oset Percent of one vertical division, maximum of 100.

Baseline Use this section to enable/disable the Baseline in the display.

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Timebase [ms/div] Use this eld to set the time window for the displayed data. Peak to Peak Ampl Select this eld to display the value. Accept/Reject Repl Select this eld to display the numbers for all replications in the D Wave stack window. Replication Number Select this eld to display the value. AUC Replication Select this eld to show AUC on the replications. AUC Baseline Select this eld to show AUC on the baselines. Only Responses When checked, put only responses in the stack. TOF Calibration Select this eld to show TOF calibration traces. TOF [%] Select this eld to TOF % or TOF Count. If unchecked, then the system shows Peak-to-Peak Amplitude. Split Use this eld to select the orientation of the split stack display.

Numeric Settings

Numeric Settings Field Numeric Settings Field Description

Open/Close Modality Numeric Window

Modality Name Select this eld to modify the modality name. Font Size Use this eld to select the font size for the numeric data. Default layout The user can change the width or order of the columns using the left mouse button. Click [Default layout] to reset

Select this eld to place the window on the top in the thumbnail tray.

the window layout. The user can also reset the layout by Double-clicking on the header bar, or below the rows in the window.

Markers Settings

Markers provide a convenient means of labeling D Wave features. Markers can be placed on the Building Average, Last Average, Replications, and Baselines.

When the system displays baselines and baseline markers in the Trace/Stack windows, the system displays amplitude and latency values for the markers on replications and last averages as percentage changes to the baseline values.

Markers Settings Field Markers Settings Field Description

Trace Window Use the Trace Window settings to enable/disable marker features which appear in the Trace window. Stack Window Use the Stack Window settings to enable/disable marker features which appear in the Stack window. Channel Use this eld to select the channel for which the markers will be dened. Name Use this eld to enter marker names or select from a list of predened markers. Type Use this eld to dene the type of marker being tracked. The available marker types are; Peak, Trough, Fixed, and

Manual. Peaks and Troughs of a channel are dened as points for which at least two samples, on both sides, must lie below

or above that point, respectively. A Fixed Marker Type will remain stationary at the selected latency position.

Center Use this eld to dene the center of the Peak or Trough Marker or the position of the Fixed Marker in milliseconds.

Click in the eld and select the time length after the beginning of the stimulus trigger when the peak or trough’s center will occur. The available range begins either at zero (the stimulus onset) if a pre-stimulus delay has been selected, or at the value of the post stimulus delay. The end of the range is the sum of the dened sweep length and the sweep delay.

Interval This eld denes the time interval, in milliseconds, for which the Peak or Trough Marker will track the desired EP

feature. The interval is equal on both sides of the marker center. For example, if the center is set to 15 ms and the interval chosen is 2 ms, the EP feature will be tracked from 13 to 17 ms.

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Stimulus Settings

The Stimulus settings panel provides stimulation settings for the modality modes used during a procedure. These settings are described below. Note: Some settings are only available when the system is in SD Advanced Mode. To adjust stimulation settings:

1. Click the Stimulus icon.

2. Click the down arrow icon next to the modality to reveal stimulus settings. In SD Advanced mode, users can do the following to adjust advanced stimulus settings:

1. Click the ellipses (...) on the right side of the panel to reveal advanced stimulus settings.

2. On the additional stimulus settings window, complete the elds, as necessary, then click [Apply]. The following elds appear on the Stimulus Settings panel but are not applicable to all modalities.

Stimulus Settings Field Stimulus Settings Field Description

Trigger source The Trigger source setting is used with Trig EMG. Every stimulus generates a sweep if the user selects Stimulus. The

stimulation is disabled and the system generates a sweep when the signal is above the threshold if the user selects

Threshold. Rate Use this eld to set the desired stimulation rate. Probe [mA] Use this eld to increase or decrease stimulation delivered to the probe. EMG stimulation is a constant current

source. Suppress Stimulus

Artifact Suppress Train/Double

Train Artifact Show selected pedicle

levels only TOF [mA] Use this eld to set the stimulation current for the TOF test. MEP [V] Use this eld to set the stimulation voltage for the MEP test. Mode Use the mode setting to determine how the stimuli are to be applied.

Set ASI The Set ASI (After Stimulus Interval) setting is only available in Single Sequence mode. The Set ASI determines the

Duration Available only for the Speech Mapping modality. Use this eld to select the maximum time for stimulation. Disable Interval Only available for the Speech Mapping modality. After the user stops the Speech mapping stimulation by

Use two Neural Proximity stimuli

Select this eld to enable stimulus artifact suppression and set the interval of suppression in milliseconds.

When ON, the system extends the stimulus artifact suppression to the end of the train/double train.

Select this eld to show/hide and enable/disable all pedicle level buttons in the Stimulus Settings panel. To enable

individual pedicle level buttons, select the desired pedicle level.

• Repetitive mode repeats the stimuli throughout the modality.

• Non-repetitive mode activates the next stimulus once each time the Pause/Resume button is pressed.

• Single Sequence mode activates all stimuli in the current modality once each time the Start button is pressed.

• External mode generates a stimulus when a trigger pulse is detected on the Trigger Input connector.

interval between this stimulus and the next stimulus. The available range is from (Sweep Length + 8) ms to 100000

ms.

removing the probe, or reaching Duration time, do not start another stimulation until set Disable Interval expires.

Only available for the Neural Proximity modality.

Electrical Stimulus Advanced Settings Window

The following elds appear on the advanced stimulus settings window but are not applicable to all modalities.

Advanced Stimulus Settings Field

Mode Used this eld to select the stimulus mode. Four modes are available, Hi El 100mA/400V, Low EL 4mA/ 4V, Fast MEP,

Type Use this eld to select the stimulation type. Voltage and Current are the available stimulation types. Polarity Use this eld to select the polarity of the pulse. The polarity selections are Normal, Inverse, and Biphasic. When

Output Unilateral (stimulus from only one stimulator output).

Advanced Stimulus Settings Field Description

and Slow MEP.

Biphasic is selected, a positive pulse is followed immediately by a negative pulse of equal amplitude and duration. Use the biphasic mode to achieve zero net charge (cancellation of positive and negative charge) stimulation.

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Advanced Stimulus Settings Field

Pulses Use this eld to select the type of pulse that is delivered. A single stimulus is one pulse, delivered at a stated

InterTrain Interval Used for double trains. The InterTrain Interval is the interval between the start of the rst train and the start of the

Pulse Duration [μs] Use this eld to select the duration of the pulses in micro seconds. Train Count Use this eld to select the number of pulses to be included in the train. Train Rate Use this eld to select the train pulse rate in pulses/second. Train Interval The system calculates the Train Interval from the Train Rate. The system calculates the Train Rate when the user

Stim Port This eld displays the stimulator port in use. Max Current [mA] Use this eld to set the maximum stimulation current for the Intensity slider. Max Voltage [V ] Use this eld to set the maximum stimulation voltage for the Intensity slider. Intensity Step Use this eld to set the intensity step from 0 to 20 mA or Volts for High Electrical mode. The increment above that

Advanced Stimulus Settings Field Description

interval; A train is a sequence of identical pulses. The responses to the train stimulus are recorded as a single sweep. The train rate and count may be selected from the list box as desired; A Double train is two pulse trains as described above separated by an adjustable intertrain interval.

second train.

enters a Train Interval value.

limit is 1 mA or Volt per step. Use this eld to set the intensity step for Fast MEP and Slow MEP modes.

Neural Proximity Advanced Stimulus Settings

Auto Intensity Max [mA] Use this eld to enter the maximum intensity used in the searching algorithm. Threshold Low [mA] /

Threshold High [mA]

Three dierent tone frequencies are used to indicate the stimulus current intensity needed to evoke an EMG response. Tone Threshold Low and Tone Threshold High parameters dene the intensity levels at which the audio tone changes.

Pedicle Screw Advanced Stimulus Settings

Auto Intensity Start/ Maximum

Fail If Below If the stimulus intensity current needed to evoke a response is below this value, the screw test fails for that level. Pass If Above If the stimulus intensity needed to evoke a response is above this value, the screw test passes. Stop After First Response Check this box to stop stimulation and auto testing when a response is found for a single channel. If not checked,

Dierence to Nerve Root When the setting is on and the nerve root has been tested, the dierence between the pedicle screw test intensity

Fail If Below Di If the dierence of stimulus intensity is below the desired value, the screw test fails for that level. Pass If Above Di If the dierence of stimulus intensity is above the desired value, the screw test passes.

These settings dene the Start (minimum) and End (maximum) stimulus intensity current used in the test.

the stimulation will continue until the End Intensity is reached.

and nerve root intensity needed to generate a response is used to determine the result, using the following two thresholds.

Nerve Root and Train of Four (TOF) Advanced Stimulus Settings

Auto Intensity Start/Auto Intensity Maximum

Use these elds to set the Start (minimum) and End (maximum) stimulus intensity current used in the test.

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Secondary Windows™* Settings

Use the Secondary Window Settings panel to select additional settings for the timer and to set up a camera.

Timer 1

The Timer windows provide a simple stopwatch with the following features:

• Use the Name eld to type the name of the timer.

• Select Reset on MEP Stimulus to enable the timer to reset when the system generates a MEP stimulus.

• Select Warning to enable the timer to display a warning at a designated time interval. When the warning is activated, the timer color

changes to red until timer is reset.

• Use the Interval [min] eld to select the stopwatch time.

• Use the Stopwatch Mode to set a countdown for the timer.

• Use the Start/Stop and Reset buttons to control the timer.

Surgeon Screen

The Surgeon screen displays on a second monitor and can provide information for the surgeon. Connect the secondary display to the laptop, select Extended Mode and congure the screen sharing parameters prior to starting the NIM-Eclipse™ E4 System software.

After the test begins, select the Surgeon screen control to open the surgeon window on the monitoring display. Adjust the information and appearance of the screen with the following parameters:

• Use the Source eld to select the information that appears on the Surgeon screen.

• Use the Target eld to select the position of the information on the Surgeon screen.

• Use the Target Width and Target Height elds to adjust the size of the information that appears on the Surgeon screen.

Camera 1

The NIM-Eclipse™ SD System has the ability to import one video and one audio input simultaneously. The cameras or video input can be used for microscope, operating room, patient or other views. Use this window to preview and record from the camera and audio devices.

• Use the Camera Device eld to select the camera input.

• Use the Audio Device eld to select the audio input.

Speaker Settings

Use the Speaker Settings panel to set the Raw EMG audio and various tone settings. Muting of Raw EMG audio is also controlled from this panel. The following elds appear on the Speaker Settings panel.

EMG Audio Volume Use the slider to increase/decrease the overall volume of both the EMG audio volume. Tone Volume Use the slider to increase/decrease the tone volume. Audio Output Use this eld to select the computer or the ECLC as the audio device. EMG Tone Use this eld to select which EMG tone is audible and also if the audio tone is enabled or disabled. Pedicle Screw Audio Use this eld to set the pedicle tone type. The pedicle tone types available are a tone or voice. Speech Mapping

Audio Tone Duration Use this eld to select Short, MEdium or Long duration of the tone. Impedance Warning

Beep Current Applied Tone Use this eld to enable/disable the tone for applied current to the patient. Continuous tone When enabled, a tone is heard for every delivered stimulus. Timer Warning tone Use this eld to enable/disable a tone when the system generates a Timer warning. Screenshot Tone Use this eld to enable/disable the tone when a screenshot is taken. Chat Message tone Use this eld to enable/disable a tone when a new chat message has arrived. Probe buzzer Buzzer provides audible feedback of a probe button press. Same EMG tone for all

channels

Use this eld to set the audio type. The Speech Mapping types available are tone or voice.

Use this eld to enable/disable the Impedance Warning Beep.

When the user selects this checkbox, the system uses one tone for all EMG channels. Select the channel tone by clicking on a Tone test button.

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Positive and negative response tones

Mute Stimulus Artifacts

Mute below Use this feature to silence low level EMG and attend only to those EMG bursts above the set level. When the Mute

Mute above Raw EMG artifact level

Mute High Frequency Artifacts

Enable EMG Audio Use this eld to enable/disable EMG Audio. EMG Audio by

Channel EMG tone by channel Use this eld to enable/disable the EMG tone by channel. Tone Test Click on the speaker icon to hear the tone associated with the corresponding channel.

When the user selects this checkbox, the system uses the selected tone for positive responses. Use the tone for the channel above the selected channel for negative responses.

Use this eld to reduce the sound level of the artifact. Stimulus artifact can be present when recording EMG during direct nerve stimulation. The artifact sounds like a click or pop and occurs with each stimulus.

EMG Below feature is enabled, audible EMG activity will be muted if the EMG signal is below the set level for all selected EMG traces.

When the user selects this and the Art.Rejection checkbox, the system mutes parts of the Raw EMG channel when the data is above theArtifact Level.

Check every 4 ms of Raw EMG for muting. Mute the Raw EMG audio in that interval if the signal is no less than the Above [peak-peak μV] value and the system detects a high frequency artifact. Display the 4 ms Raw EMD data with the Current Sweep (Live) color when the system mutes the audio.

Use this eld to enable/disable Raw EMG audio by channel.

Comments settings

The Comments window displays time stamped events that occur during a procedure and user dened comments that are typed in the Comments eld or selected from the predened comments list. Comments are available in Review Mode and can be printed to the Summary report.

There are three types of comments: system generated comments, user entered comments, and predened comments.

System generated comments

The System automatically saves and displays events that occur during a procedure.

User entered comments

Users can enter comments as necessary during a procedure. When comments are created there is a one hour grace period for editing the text. After that, every edit will create a new revision of the comment that can be reviewed. When a report is printing comments, only the most current revision will be included.

To enter comments:

1. Click the Comments eld at the bottom of the screen.

2. Enter comments.

Predened comments

The Comments Settings window allows users to save comments, edit comments and load saved comments. Additionally, users can determine the types of comments the system generates automatically and whether or not the comments appear in the Stack windows.

To save comments:

1. Click the Comment settings icon.

2. Type a comment in the comment eld, then press Enter.

3. Click the Save icon.

4. Name the comment le, then click Save. To Load Comments:

1. Click the Comment settings icon.

2. Click the Load icon.

3. Select the appropriate comment le, then click Open.

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Auto Comments

To select comments automatically generated by the system:

1. On the Comment Settings window, select any of the following elds to enable/disable the automatic generation of a comment.

• Screen Save: Automatically generate a comment when a snapshot is saved.

• Impedance: Automatically generate a comment when an impedance is performed.

• Pedicle Screw Test: Automatically generate a comment when a pedicle screw test is performed.

• Nerve Root Test: Automatically generate a comment when a nerve root test is performed.

2. Click [OK].

Show Comments

To select whether or not comments appear in the Stack windows, On the Comment Settings window, click the box next to Stack Window and then click [OK].

The system displays all comments if the Most recent only checkbox remains unchecked. If the user checks Most recent only, the system displays only the most recent comment.

Comments File

The system creates a text le with comments when the user starts a test in the “C:\NimEclipse\Log” folder. The system adds every new comment to that le. The le can be read by other programs while the test is running. When the user closes the test, the system deletes the les.

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Section 5: Monitoring and Review

In this section, you will be able to:

1. Understand the Monitoring screen and windows

2. Use the Surgeon-Controlled Probe

3. Manipulate the Monitoring screen

4. Save and review screen captures

5. Review Data

6. Print Settings

7. Develop Report

8. Create and Edit Templates

Monitoring and Review

NIM-Eclipse™ System Monitoring Screen

Below is a brief description of the function of each button and icon shown on the Monitoring Window of the NIM-Eclipse™ SD System.

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9 10

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1. System Menu: Use this menu to access Save, Save As, Review Test, System Info, Setup Help, Help, User’s Manual, Support, and Close to exit the system.

2. Modality tabs: controls which modality is active during a test. When selected, the active modalities change color to orange.

3. Increase/Decrease Sensitivity buttons: increase/decrease the amplitude display of the active channels. Use Shift + mouse wheel to change sensitivity for all channels in the window under the mouse pointer. Use Ctrl + mouse wheel to change sensitivity for the channel under the mouse pointer.

4. Increase/Decrease Timebase/Sweep Length buttons: increase/ decrease the timebase/sweep length setting of the active channels.

5. Congure Channels button: allows users to Identify and assign electrodes and channels and check electrode impedances.

6. Minimize, Maximize and Close Window buttons: allow users to minimize, maximize, and close the monitoring window.

7. Modalities Settings: Allows users to congure trace and stack display parameters for the selected modality.

8. Stimulus Settings: Allows users to congure stimulation settings for the selected modality.

9. Secondary Windows™* Settings: Allows user to congure secondary window settings.

10. Speaker Settings: Allows users to congure audio settings for

EMG, and Pedicle modalities.

11. Print Settings: Allows users to congure document output settings.

12. Patient Information: Displays a series of sections that allows users to enter information about case including personal Info, and Case Sta, Case Info.

13. Remote Monitoring Settings: Displays settings for a remote monitoring session.

14. System Settings: Allows users to congure system settings such as the display language, units, and status bar displays.

15. Comments: Allows users to add comments to a test during the procedure.

16. Chat: Allows users to communicate during a remote monitoring session.

17. Show/Hide settings panel: Shows/hides the Settings Panel.

18. Resize Window: Click and drag this area to resize the monitoring window.

19. Comment settings: Edit, create, and save predened comments.

20. Comment Text Box: Use this area to type comments.

21. Screenshot icons: Press the camera icon to captures a screenshot of the trace, spine, pulse oximeter, and intensity windows. Use the folder icon to browse captured screenshots. Note: If the Ctrl button is pressed when the snapshot icon is clicked, the entire NIM-Eclipse™ System window will be captured.

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Monitoring screen sections

Test window screens have common features: Spine View, Pulse Oximeter, Stimulation, Timer, and Trace windows.

Pulse Oximeter window

The Pulse Oximeter window displays left and right pulse oximeter oxygen saturation and heart rate in some of the the modes. Oxygen saturation appears when pulse oximeter sensors are connected to the patient. Up to two sensors can be used. This window also displays the menu activated by the Surgeon-Controlled Probe and instructions for specic tests.

Note: Pulse oximeters are not approved for use with the NIM-Eclipse™ System in Brazil and Canada.

EMG Tests window

The EMG Tests window displays the stimulation intensity, measured patient current, selected pedicle level for testing, and the result of this testing.

To increase/decrease stimulation:

1. Press button 1 or button 2 on the Surgeon-Controlled Probe to increase or decrease the Set current, respectively.

2. Press and hold either button to quickly increase or decrease the current. Alternatively, use the buttons in the EMG Tests window or the probe slider in the Stimulus Settings panel to increase/decrease the stimulation.

EMG and Pedicle Screw stimulation use a constant current rectangular pulse with parameters dened in the Stimulus Settings panel. The other EMG Tests windows display the Set and Measured electrical stimulation intensity. Intensity changes automatically and cannot be

manually controlled. The measured currents are color coded, based on the measured current:

Green Above Threshold High Red Below Threshold Low Yellow Between Thresholds

When Dierence to Nerve Root is enabled in SD Advanced Mode, the measured intensities for the nerve root, the screw and their dierence will be displayed. Stimulation begins at the Start intensity and either continues to the End Intensity or stops when a response has been found. When the test completes the stimulus intensity needed to elicit the response for the selected pedicle level is displayed. Additionally, the Vertebral Level that is tested appears.

The MEP stimulation area displays the Set Voltage intensity and patient current. MEP stimulation uses a constant voltage, biphasic pulse train with parameters dened in MEP Settings. The biphasic pulse train provides a positive pulse followed immediately by the same amplitude and duration negative pulse. This mode will simultaneously stimulate both hemispheres non-preferentially.

When the test is rst selected, the Set voltage is 150 V. If the test mode is changed, and then returned to MEP, the set voltage will return to its previous value. Click on the up or down arrows to increase or decrease the Set voltage respectively. The current delivered to patient is displayed in the box. The patient current is negative because of the biphasic stimulation pulse. The Surgeon-Controlled Probe can also be used to control the set voltage.

Trace window

The Trace window displays the Raw EMG, Triggered EMG, Train of Four, Neural Proximity, Pedicle Screw, Nerve Root, MEP, and Motor Mapping and D Wave responses. Up to eight channels can be displayed. Some tests may require, or use, fewer than eight channels.

The area is divided into left and right sections and traces are color-coded to match the electrode leads and channel colors of the Patient Interface Module.

Red Channel 1 & Channel 5 Blue Channel 2 & Channel 6 Violet Channel 3 & Channel 7 Orange Channel 4 & Channel 8

The amplitude of the EMG signal is represented by the vertical portion of the display. The timebase divisions are represented by the horizontal portion of the display.

The Trace windows display numeric values for the amplitudes of the signals in each channel. Train of Four (TOF) responses are EMG compound motor action potentials (CMAP) in response to each stimulus in the TOF stimulation pattern.

The responses are displayed shifted and superimposed. The maximum peak-to-peak amplitude of each response is measured and the T4/T1 ratio is calculated. The scale is automatically calculated and displayed on the lower right when the user clicks Auto Sensitivity. TOF responses are scaled automatically and are based on the higher of the baseline calibration and rst response in the TOF train. The CMAP peak-to-peak amplitude must be above the threshold to be considered a valid response.

The MEP test mode displays EMG responses as single sweep evoked response trace or stacked traces (in SD Advanced Mode).

Stack window

The stack window shows multiple replications for triggered sweeps.

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Spine View window

The Spine View window displays a graphic representation of the spine levels that are selected for the protocol and channel buttons. Spinal level buttons are displayed for certain tests. Left and right spinal level locations are always shown relative to the spine view.

In the Stimulus Settings Panel, users can select the spine levels (represented by pedicle level buttons) that are needed for the test. When a spinal levels button is pressed, the test starts. Stimulation is increased and a response is either found or not found within the stimulation

limits. The measured current value, at which a response was found or maximum current limit was reached, is displayed next to the tested level button. The spinal level buttons display the test results for that level as follows:

Red Fail Yellow No Decision (Intermediate) Green Pass

When the test is started by pressing a spinal level button, the test result is marked with that level name for later review. Pressing a spinal level button that has been previously tested will result in the test repeated for that level and the earlier result discarded. Switch the posterior/anterior view by pressing the [Anterior] or [Posterior] button.

Timer window

The timer window shows a digital timer that can be used to manually capture elapsed time.

Speech mapping window

Use the speech mapping window to adjust the stimulation intensity and to start and stop speech mapping.

Probe control of menu functions

The two-button Surgeon-Controlled Probe can be used to change tests, initiate, increase, and decrease stimulation, print a report, or request attention from the remote monitoring site.

Press and hold both buttons to access the Menu. The information display area will rst indicate Menu and then menu options. Click with probe button 1 or 2 to move between tests or other menu options. Press and hold button 1 to select that option. Press and hold button 2 to cancel the menu. If no selection is made within ve seconds, the menu area closes without a selection.

Press button 1 to close the displayed message windows.

Dragging Elements in Trace and Stack Windows

Use dragging for the following actions:

• Move individual traces.

• Move all traces for a channel by dragging the channel name.

• Move a marker.

• Change marker interval by grabbing its end.

• Change the AUC start and end point.

• Change the maximum and minimum points.

• Move cursors.

Drag channel names in the Trace window using Ctrl+Left mouse button to reorder channels.

Right-click windows menu

Right-click over the Trace, or Stack windows to display the related menu. Right-click over a trace to display a particular set of Trace window menu items. Right-click away from a trace display another set of Trace window menu items.

Right-click over the stimulus name in the Trace window to open a window with the stimulus parameters and intensity sliders.

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Include Channels for Autotesting

Use Include Channels for Autotesting to include or exclude a channel from automated testing in Pedicle Screw, Nerve Root, and Neural Proximity modalities. When a channel is o, the channel does not appear in the window. When the channel is excluded, the system displays the channel, but it is not used in the automated algorithm.

Example: Exclude a channel from automated testing when a channel has noise that is expected to end soon.

Apply to all EMG modalities: Select this eld to apply the selections made on the Trace, or Stack menu to all EMG modalities.

Clear Traces

Use Clear Traces for MEP modalities to remove unwanted traces from the display.

Last trace (applies to all channels): Select this eld to apply the selections to the last trace only.

All traces (applies to all channels): Select this eld to apply the selections to all traces.

Baseline (applies to all channels): Select this eld to apply the selections to the Baseline trace.

Monitoring and Review

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Monitoring and Review

Next Average

Use Next Average to begin a new average at any time. For example, if a grand average of 500 sweeps has been chosen and the building average shows an identiable evoked potential after 200 sweeps, you may improve response time by starting a new average immediately.

The Next Average starts the selected EP traces only. Channel: Select this eld to include all of the traces. All of the traces

are selected once the next average button is selected. Reset Building Average: If the user selects this eld, the the system

clears the building averages for the selected channels and the new building averages start. If the user does not select this eld, the system continues the current building average.

Save Building Average: If this eld is selected, the building averages for the selected channels will be saved as last averages before the new building averages start. If this eld is not selected, the current building average will be lost.

Example: 3 traces on the left and 3 traces on the right. Five of the traces are good, but one trace is unclear. Select next average and deselect the unclear trace. The other traces continue on to the next set of sweeps, but the unclear trace continues to nish the rst set of sweeps to obtain a better waveform.

Baselines

Use Baselines to install the last averages as baselines for the selected EP channels.

The Use selected traces checkbox appears when the user opens the Baseline dialog window from the Stack window menu. If the user selects the Use selected traces checkbox, the system sets the selected trace as a baseline for selected channels with only one selected trace (the system ignores channels without selected traces or multiple selected traces).

When the user clicks [OK] and checks [Use baselines installed during the test], the system shows the baselines used during the test at the selected time. This setting is available in review mode only.

Note: The system must complete a full sweep of traces before you can set a baseline.

Reset EP Traces

Use Reset EP Traces to reset the selected EP traces. The window contains a series of check boxes for these features:

• Last Average

• Building Average

• All Replications

• Baseline

Use these checkboxes to select/deselect the data that will be reset.

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Cursors dialog

Trace window

Trace cursors are two vertical cursors per EP or Trig EMG Trace. To

display a cursor, move the pointer close to the left border of the window, or select it in the Cursors dialog. When the cursor appears, drag it to the desired position. If you drop the cursor mark on a trace it follows the trace point. To delete a cursor, drag it to the left border of the window or unselect it in the Cursors dialog.

The user can choose Multiple cursors in the Trace and Stack windows. The user can choose up to eight vertical (latency) and horizontal (amplitude) cursors in the Trace window and each stack channel.

Monitoring and Review

Stack window

In the Stack window – select the channels for which cursors will be visible.

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Add alert/alarm

Add Alert/Alarm - Opens a dialog window used to add an alert or

alarm. The system generates a comment when the user creates an alert/alarm.

Other right-click options

Save Building Average - Use the Save Building Average dialog to save

it without starting another average when used while the modality is stopped.

Cursors – Open the Cursors dialog to select the cursors for the window.

More Replications/Less Replications – The system switches between these two modes when the user selects one or the other.

Auto Hide Traces – When the user selects Auto Hide Traces, the system only saves traces immediately before and after the selected comments are visible.

Hide Trace – Hide selected highlighted traces. The system highlights Traces when the user hovers the mouse pointer over them. Use the Ctrl+left mouse button to select a single trace in the Stack window. Use the Shift+Left mouse button to select the whole row in the Stack window.

Unselect Traces – Unselect all selected traces in the Stack window. Unhide Trace – Unhide the last hidden traces. Unhide All Traces – Unhide all hidden traces. Zoom Trace – Zoom the selected channel in the Stack windows. Equalize Traces – Set the traces to their default positions. Update Comment – Update a comment for modied peaks in the TOF

trace window.

Copy Window – Copy the window to the clipboard. Markers – Open the Marker settings panel. Place Marker – Open the Place Marker dialog. Remove Marker – Remove the highlighted marker.

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System menu

Save: Saves the current version of the protocol. If the protocol is a predened Medtronic protocol, which cannot be modied, the Save As window automatically appears.

Save As: Opens the Save As window for saving the protocol as a new le. Close: Closes the current protocol. A window will appear asking the user if they want to save the changes to the protocol. System Info: Displays system name, version date, program version, Controller, DAQ version, ESM Main version, ESM1 version, and ESM2 version

data. Setup Help: Opens a window with pictures for proper positions of the electrodes on the patient’s body. User’s Manual: Opens the NIM-Eclipse™ System User’s Manual window. Use this window to access electronic copies of the NIM-Eclipse™ System

NS, SD, or Service Manual. Support: View help materials and contact support information. Close: Closes the system menu.

Screenshot capture

The system is capable of capturing screenshots during procedures using the screenshot icon. Click the screenshot icon at any time during a procedure to capture the data portion of the NIM-Eclipse™ System window and save it to a folder on the NIM-Eclipse™ System. Press [Ctrl] and click the screenshot icon to capture the entire NIM-Eclipse™ System window.

Review saved screenshots by clicking on the browse folder next to the screenshot icon.

Screen and window view customization

Note: This feature is available only in SD Advanced mode.

Dene which modalities appear within a particular layout tab by dragging and dropping protocol windows from the thumbnail tray into the Monitoring screen. Existing sections can be moved by clicking on the top bar of the window when the cursor is the shape of a hand. While holding down the left button of the mouse, drag the window to a new location.

The height and width of a window can also be modied. When the cursor turns into a two-sided arrow, click and drag the window edge until the desired dimension is reached.

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NIM-Eclipse™ System Review Data Screen

The NIM-Eclipse™ System allows you to review saved data for any patient. Data can be recalled for review either selectively, by time or comment, or automatically “played back”. For example, EMG data can be reviewed by playing back the scrolling EMG as it was recorded. The Review Data screen must be accessed from the Run/Modify Test Selection screen after opening the NIM-Eclipse™ System software by clicking Review Test.

Below is a brief description of the function of each button and icon shown on the Review screen of the NIM-Eclipse™ System:

1. Review By: When reviewing stimulated EMG modalities using Previous, Next or Play buttons, data will be selected based on this selection. If EMG Modalities is selected then the next available data, regardless of the modality, will be selected. If it is a dierent modality, the screen will be switched. When the Selected Modality is used only data from the active modality will be displayed.

2. Previous/Next: Select the previous/next saved triggered EMG/EP data. The previous/next button moves in 4 second intervals for the Raw EMG.

3. Play: Plays data automatically and works in similar way to the Next button when clicked repeatedly.

4. Review Bar: The Review bar allows users to skip to a particular place in the test during playback. When reviewing data that was collected using the Resume Test function, the time markers for the viewed data can be noted in the Trace windows on the Review screen. If the user resumes data collection using the Resume Test tab, the time increments on the progress bar display the last data collected until the progress bar reaches the resume data point . When the progress bar reaches the new data point, all new data appears.

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Review a test

To select a test for review:

1. Click [Review Test] on the NIM-Eclipse™ System Main screen.

2. Click a patient test from the list.

3. Click Review.

NIM-Eclipse™ System Review Data Functional Keys

Use the following functional keys on the keyboard to perform NIM-Eclipse™ System functions while reviewing data.

Key Review Test

F1 Help F2 Previous F3 Next F4 Play/Stop F5 Remote Sync Screen F6 Remote Live On/O F7 N/A F8 N/A F9 N/A F10 Print screen F11 Speaker On/O

Monitoring and Review

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Monitoring and Review

Print Settings

The system produces detailed reports in several formats. These formats are PDF and HL7. You may print data at any time during Test or or Review. The reports can be generated locally to a variety of supported printers. Reports can also be saved to a le and attached to Email. You may also select options relating to HIPAA and patient privacy.

Output

Use the printer and HL7 features to select the format of the test data output. When the Printer tab is selected, the system displays the printer menu, properties button, and a PDF Reports button. When the HL7 tab is selected, the system displays the check box for “View report in HL7 File Viewer”, and a PDF Reports button.

The Printer menu allows users to select a congured printer for system printing. The Properties button displays the selected printer’s properties. The PDF reports button allows users to open the default folder where the PDF reports are saved.

Comment

The Comments text box is a free text area to add additional comments to the report.

Select Reports

The Select reports section contains the Summary, Comment History, Trace, Stack, and Patient Info report types. The system outputs each of the enabled reports when the user clicks [Print Report]. [Print

Screen] creates a one-page report.

Professional Report

The Template Section allows users to select predened report template for the professional report.

Click [Report Generator] to open the professional report program.

Report Header

The Report Header section includes text boxes used to add information to the reports header. This information includes Hospital Name, Department/phone, Address, and City/state/zip code.

The report header section also includes an area to enter a legal notice regarding the condentiality of medical records and Health Insurance Portability and Accountability Act (HIPAA).

Report Parameters

Report Parameter settings enable/disable additional features to the report such as black and white print output, including the patient name on the report header, including the legal notice, changing black to white background, fast print screen to PDF using the eDoc PDF Pro printer without opening the save dialog for the report.

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Report Generator

The Report Generator allows you to create highly customizable reports with a minimum of typing by using templates.

Templates

A template is a set of forms with placeholders for data. Each template has exactly one form called MAIN – this is the form representing the entire report. When printing, select the template and the Report Generator takes the template’s MAIN form and lls in the data.

Once the MAIN form is automatically lled in, the document can be printed or further edited. In many cases the MAIN form may be all you need to create a report. However, you may also have blocks of text that are specic to certain types of procedures. In this case, you can have a template with a generic Main form and any number of additional secondary forms. You can insert these forms by dragging them from the forms pane onto the document pane. As you drop these forms, all data elds will be automatically lled in.

If the template has a large number of additional forms, nding the right one may become dicult. To alleviate that, forms may be assigned a group name. You can then use the FILTER button to show only the forms from a particular group. Use CLEAR FILTER to show all forms again.

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Lists

Forms are complex blocks of text that may span multiple paragraphs, contain images, tables and data placeholders. However, there may be simple chunks of text that you often use, such as muscle names, diagnoses etc. Instead of typing them, you can insert them from the INSERT / LIST ITEM menu.

Lists are customizable via the EDIT LIST button. There are a few system lists that are xed. Their content can be edited but the lists themselves cannot be deleted or reordered. In addition to them, you can dene any number of custom lists containing arbitrary data.

Lists are installed with some predened data.

Editing Lists

The button brings up the List Editor. Here you can add lists and add items to existing lists. You can also delete or reorder lists and items by grabbing them by the handle and dragging them. To delete anything, drag it to the Recycle bin. You can delete items or entire lists. You can add new lists and list members by clicking on the or by pressing Enter while editing the previous item. Some lists have a little padlock instead of a drag handle. Those are the system lists and they can’t be deleted or reordered. However, you can still add, remove and reorder the items in these lists.

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Printing

Once the report is ready for printing, select the PRINT tab. In the print preview, the pages are shown exactly as they will print. Use the zoom options to inspect your document and then click the PRINT button to send it to the printer. Alternatively, you can go back to the Edit tab for further changes.

When the Report Generator is opened from within NIM-Eclipse™ SD System, it will ll the Main form and if no data is missing, will go directly to the Print tab. If there is missing data, the Report Generator will go to the Edit tab since you most likely will need to edit the missing elds before printing. The missing elds appear highlighted in yellow.

Saving the Report

You can save the report for further editing or printing. A saved report contains the report document itself, all the patient data and the template to allow further editing of the saved report. When a saved report in opened the forms pane is displayed. Since the patient data is there as well, you can drag-drop additional forms and they will be lled in on the y.

Formatting Text

The Edit tab contains the standard controls for font and paragraph manipulation. You may also include numbered or bulleted lists. The Insert tab allows inserting a table, a page break or a list item. Inserting a page break in edit mode will add a horizontal line where the break will occur. To see what the document will look like when printed, switch to the Print tab.

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Monitoring and Review

Report Tables

Tables can be used to display tabular data, but just as importantly, they can help you with the text layout. To insert a table, position the cursor where you want the table to appear and click TABLE on the Insert tab. From the popup, drag the mouse to determine the size of the table. Click the square that reects the desired size. When a table is initially inserted, all of its columns are set to “auto width”. The table grid color is light gray which means that the grid won’t be

visible when printing; it is only shown in edit mode. Table columns can either have xed width (in inches) or have “auto width”. When a table contains both xed and auto width columns, the layout

works as follows. First, from the page width the widths of all xed columns are subtracted. The remaining space is divided equally between the “auto width” columns.

You can control the column widths via the table context menu. To bring up the table context menu, right-click anywhere in the table. You can add/remove rows, toggle between invisible and visible grid and set column widths.

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Monitoring and Review

Example: Text Layout Using Tables

In the Report Generator, tables are used to control the layout of text. Suppose you want your company logo to appear on the top right of the rst page. To do that, rst insert a table with 2 columns:

Next, copy the logo image from another program and paste it in the right column:

Columns are “auto width” by default, meaning that they take up the whole page and divide the available space equally. To adjust the right column, position the cursor inside the column and right-click to bring up the table menu. Click the plus or minus buttons until the column is the desired size.

The logo is placed. Note that the table grid is light gray, meaning the grid lines will not print.

Anything can be inserted inside a table cell including formatted text with its own alignment, bulleted lists and even nested tables.

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Monitoring and Review

Create and Edit Report Templates

Templates are created and edited from within the Report Generator. Click the Edit Template button to toggle the Template editing mode on and o.

The template editing mode opens a form editor window under the document window. In addition, each form in the forms pane has two buttons: edit and delete.

Use the edit button to modify the form in the form editor. Use the delete button permanently removes the form. The form editor controls are the same as the document window. The form editor has three additional controls: Group name, New form and Insert

eld. You can resize the form editor up to the whole available space. The convenience of having the document window open as well is that you can

copy and paste between the two windows. For example, while writing a report if you type a paragraph that may be used in other reports you can quickly add it to the template. To do so, toggle TEMPLATE EDIT, copy and paste your paragraph from the document into the form editor, and toggle TEMPLATE EDIT again to close the form editor. Now your paragraph is included in the template and you can just drag and drop it if needed in future reports.

Adding Data Fields

If the paragraph you want to add to the template contains the patient name, we need to insert a data eld that will be lled with the actual patient name for each report.

In the form editor, position your cursor where you want the data eld to be inserted. Click the INSERT DATA FIELD button. A popup appears with a list of available data elds. Click on the data eld you need and it will be inserted in the form. Since there are many data elds, it may be dicult to nd the one you need. If you know approximately what the eld name should be, just start

typing it in the search box and the selection will narrow down as you type.

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Section 6: Remote Monitoring

In this section, you will be able to:

1. Start and End a Clinical System Remote Monitoring Session

2. Start and End a Remote System Remote Monitoring Session

3. Initiate a Text Chat Session

Remote Monitoring

NIM-Eclipse™ System remote monitoring

The NIM-Eclipse™ System provides two exible approaches to remote monitoring depending upon the remote monitoring connection scheme. Connections between the monitoring site (Clinical System) and the remote review site (Remote System) can be made through an Internet connection.

The user can establish Remote monitoring using one of two available modes per session:

• Screen Share: Screen Share allows the remote view site users to view the Clinical System screen but they cannot change the screen layout, view, or settings.

• Share Data: Share Data allows the data to be streamed from the Clinical System to the Remote System so that the remote review site user can change their view of the data without changing the Clinical view.

• Text Chat: Text Chat allows monitoring site users to chat with remote review site users once a remote connection has been made between the Clinical System and the Remote System, regardless of which remote monitoring mode the user selects. To save the chat log, right-click on the chat window and export the text.

Clinical system remote monitoring session

To enable a remote connection from the monitoring site (Clinical System) to the remote review site (Remote System), do the following:

1. On the Main screen, click the Remote Monitoring icon.

2. In the Remote Monitoring Settings window, press [Enable networking]. Note: If desired, select the Auto-enable networking check box to automatically enable Remote Monitoring functions in the future. When enabled, the IP address appears in the Remote Hosting section.

3. Ensure the remote user has an account on this computer. The system lists remote users in the Remote Monitoring User Accounts section. If a user does not exist, select [+] to type a user name and password. If desired, select the Auto-Accept check box next to the user name to enable that remote user to automatically connect to the Clinical System.

Notes:

• The user may manually add remote users by placing those users in the NimEclipseRemoteUsers Local Group in the Windows™* operating

system.

• To manually congure Auto-Accept, add the remote user to the NimEclipseRemoteUsersAutoAccept Local Group in the Windows™*

operating system.

• The user may use Active Directory credentials.

4. From the Hosting Services section, select the type of remote monitoring service, Share data, or the Screen Share screen.

5. The system is now ready to accept remote connections. Important: When the Remote System communicates with the Clinical System, if a user has not been given permission to Auto-Accept, the monitoring site user must accept the remote review site user to complete the remote monitoring service connection. Press [Accept] in the Remote Monitoring Settings window to accept the connection.

Note: Up to four remote users may connect to a single Clinical System simultaneously.

6. To disconnect a remote user, press [Disconnect].

When the remote connection is activated, the Remote Monitoring Settings window displays additional details under Remote Clients. The additional details include; User, Connection Duration, Data Rate in Kpbs, and Response time in ms.

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Remote Monitoring

Remote system remote monitoring session

To activate a remote connection from the remote view site (Remote System) to the monitoring site (Clinical System), do the following:

1. On the Main screen, press [Remote View]. The system displays the Remote Browser window. Note: The software version of the Remote System must match the software version of the Clinical System.

2. When the system discovers clinical systems on the network, the systems appear in tabs on the Remote Browser screen. If there are no clinical systems on the network, you can manually set up a system.

Note: On the Main screen, click the Remote Monitoring icon and deselect the Enable discovery check box if Discovery is not desired.

3. A. Select the appropriate system (for found systems). B. If there are no found systems, click the add button (+) (to manually enter a system), then type your Host Name or IP Address, User Name,

Password, and then press [Request accesss].

4. Once the Clinical System accepts your connection you may select Start monitoring to begin your session.

Notes:

• If the user is using Share Data and wants to keep the Remote view layout synchronized with the Clinical system, ensure the user selects

the Synchronize automatically check box. If the user does not select Synchronize automatically, a red outline appears around the tab the user is viewing on the Clinical side if that tab is not currently selected on the Remote side.

• If the user is using Screen Share and would like to t the Clinical view to your Remote screen, select the Auto-Fit View check box.

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Remote Monitoring

OR Time

Remote View displays “OR Time”, which is operating room live time. Remote View also displays the remote locations live time on the status bar. If the network bandwidth is low and data cannot be transferred on time, the delay between displayed data at the remote location and the data in the operating room increases. The remote location can detect the increased delay by observing the dierence between the OR Time and the remote location live time.

Text chat

To create a text chat session, activate a connection between the Clinical System and the Remote System, and then do the following:

1. Click the Chat tab in the Remote Monitoring Settings window.

2. Type the text you want to send in the entry eld, then click [Send].

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Remote Monitoring

Troubleshooting remote connections

1. Ensure a network connection is possible between the two systems to be connected. If the systems are not on the same network, the user can use a Virtual Private Network. Consult the Information Technology department at your facility.

2. Ensure each side has set the correct date, time, and time zone.

6-4NIM-ECLIPSE™ E4 SD

Section 7: System Information

In this section, you will be able to:

1. Clean and Maintain the NIM-Eclipse™ System

2. Locate User Assistance

3. View the Limited Warranty

4. View Technical Specications

5. View the Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

6. Troubleshoot

7. View Symbols

System Information

Sterility

This device is provided NON-STERILE and is REUSABLE.

Cleaning and maintenance

Cleaning

1. Disconnect all power cords from system components.

2. Preparation of NIM Insert Earphones

a. Discard the single-use earbuds. b. Replace the velcro strips covering the earphone velcro pads if organic soil contamination is visible on the velcro strips. If soil is visible

directly on the velcro pads, discard the earphone set.

3. Prepare a solution of one of the following detergents in tap or puried water and at the temperature and concentration within ranges recommended by the detergent manufacturer:

a. a neutral (pH 6.0–8.0) enzymatic detergent b. a mild-alkaline (pH 8.0–11.0) non-enzymatic detergent

During application, the temperature of the detergent solution shall not exceed 40°C (104°F).

4. Clean the system components and cords by wiping their accessible surfaces with a soft, lint-free cloth dampened with the prepared detergent solution. Wipe in a single direction and away from vents and crevices until surfaces are visibly clean.

5. If residual soil is observed in a hard-to-reach area, clean the aected area with a non-abrasive, soft-bristled brush moistened with the detergent solution until the area is visibly clean.

6. Wipe accessible surfaces of the system and cords with a soft, lint-free cloth moistened with puried water.

7. If any areas were cleaned using a brush, rinse these areas with a clean soft-bristled brush moistened with puried water.

8. Dry all accessible surfaces of the system and cords by wiping them with a dry lint-free cloth. Allow moisture in any hard-to-reach areas to air-dry.

Disinfection

1. Prior to disinfection, ensure that the system has been cleaned as instructed above and that all power cords remain unplugged.

2. Wipe surfaces of the reusable system components and cords using a sterile lint-free cloth soaked with one of the following disinfectant solutions:

a. 70% isopropyl alcohol b. 0.5% accelerated hydrogen peroxide c. 0.5% sodium hypochlorite (bleach).

3. Do not allow the solution to penetrate vents or access electrical components.

4. Wipe in a single direction and away from vents and crevices.

5. Fold the wipe over to access hard-to-reach areas.

6. Allow the disinfectant to remain in contact with system’s surfaces and cords for at least 10 minutes. Re-apply the disinfectant to the areas where air-drying of the disinfectant has occurred.

7. For disinfection using bleach: After the specied disinfectant contact time, remove disinfectant residuals by wiping system surfaces as described above, using a sterile, lint-free cloth moistened with puried water.

8. Before re-using or storing the system, allow the surfaces to air-dry or wipe o visible moisture with a dry, sterile, lint-free cloth.

Disposal

Dispose of this device in accordance with hospital, administrative, or government policies.

Technical support

For further information regarding the use of this product or to report any problems, please contact Medtronic Xomed using the appropriate information provided on the contact information card packaged with each device; or contact your local distributor.

Limited warranty

A. This LIMITED WARRANTY provides assurance for the customer who purchases a Medtronic Xomed Product (hereinafter the “Product”) that

should the Product fail to function to Medtronic Xomed’s published specications during the term of this LIMITED WARRANTY (one year from the date of shipment for new Product, 90 days from date of shipment for refurbished or used Product), Medtronic Xomed will either replace, repair, or issue a credit (adjusted to reect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Medtronic Xomed or from its aliate or its authorized distributor or representative.

B. To qualify for this LIMITED WARRANTY, the following conditions must be met:

1. The Product must be used on or before its “Use By” or “Use Before” date, if applicable.

2. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling.

3. Medtronic Xomed must be notied in writing within 30 days following discovery of a defect.

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NIM-ECLIPSE™ E4 SD

System Information

4. The Product must be returned to Medtronic Xomed within 30 days of Medtronic Xomed receiving notice as provided for in (3) above.

5. Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic Xomed or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product.

C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IM-

PLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic Xomed be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of

applicable law. Users may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be aected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

NIM-ECLIPSE™ E4 SD

7-2

System Information

Technical Specications

System overview

Multitasking: Simultaneous, acquisition, processing, display, saving and printing or faxing of data.

Multimodality: Monitoring of evoked potentials, or EMG.

User interface: Keyboard, mouse and surgeon controlled probe. Probe buttons control test and print functions. Multicolor LED indicates test result

Data collection modes: Free running, averaged, or triggered responses.

Data presentation: Data are displayed in window : Spine view, Trace, Stack, and Stimulation.

Spine view window Display graphical representation of spine and controls to select spinal level and indicate test result.

Trace window: Displays continuous and triggered EMG, TOF, EP and MEP. Stack window: Displays triggered EMG,TOF, EP and MEP traces stacked in time.

Stimulation window: Displays value of set and measured stimulation intensity.

Pulse oximeter: SpO2 from two pulse oximeters displayed on screen.

Saving data: Data is saved automatically.

Data review: Previously saved data can be reviewed.

Data recovery: Automatic recovery of data after power or system failure.

Remote Monitoring: Review data remotely via network, or internet. View single or multiple sites. Data can be reviewed simultaneously from many sites. Text

Impedance test: Manual and automatic with visual warnings.

Test protocols: Standard test protocols are provided and can be modied and saved by user.

Comments: Free-form text entry saved with the test data.

Quick reports: Automatically generated for every test. Printer, PDF, HL7 and FAX output.

Setup help: Graphical descriptions of electrode setup. Speaker output: EMG trace or signal triggered tones. Speaker is automatically muted during electrocautery. Voice indicators: Voice indicates test results, settings and status.

Max stim current: 100 mA.

Stim polarity: Normal, Inverse, Biphasic.

Stimulation rate: 0.1 – 100 stim/s.

Stim pulse duration: 25 – 1000 μs.

Low pass lter: 50 – 4000 Hz.

High pass lter: 30 – 500 Hz.

Sweep Length: 1 – 5000 ms.

Response threshold: 0 – 25000 μV.

Response start: 0 – 40 ms.

Suppress stim artifact: Removes stimulus artifact from trace display.

and status. Buzzer provides audible feedback of button press.

chat.

Help: Context sensitive.

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NIM-ECLIPSE™ E4 SD

EMG Mode

Acquisition: Free running and stimulus triggered. All data can be saved.

Channels: 8, Independent On/O controls.

Raw EMG timebase: 10, 20, 50, 100, 200, 500, 1000, 2000 msec/div, 10 divisions.

EMG Audio output: On/O. All EMG channels.

Volume: Two independent controls: EMG audio, Event capture tone.

Mute below threshold: EMG audio is muted when EMG is below recording threshold.

Beep if above

threshold:

ESU muting: Automatic muting of electrocautery noise using Mute Probe or software ESU detection.

EMG stimulation

Intensity mode: Manual.

Stimulation output: Stim Control and Instrumentation.

Monitoring: On-screen display of patient current.

Response Indicators: Visual: Color.

Indicates EMG trace above threshold.

Constant current, 400V compliance into 4K Ohm load.

mode:

Audible: Variable pitch tone.

System Information

NIM-ECLIPSE™ E4 SD

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System Information

Neural Proximity Mode

Acquisition: Stimulus triggered EMG. All data can be saved.

Channels: 8, Independent On/O controls.

Quantitative EMG: Stimulus triggered peak-to-peak EMG amplitude.

Volume: Neural proximity tone.

ESU Muting: Automatic muting of EMG audio during electrocautery using Mute Probe.

Neural Proximity

stimulation mode:

Auto Intensity Max: 1 - 60 mA.

Intensity Mode Automatic.

Stimulation Output: Stim Control and Instrumentation.

Monitoring: On-screen display of patient current

Response Indicators: Visual: Color.

Constant current, 400V compliance into 4K Ohm load.

Audible: Variable pitch tone.

Screw Test Mode

Acquisition: Stimulus triggered. All data can be saved.

Channels: 8, Independent On/O controls.

Quantitative EMG: Stimulus triggered peak-to-peak EMG amplitude.

Volume: Status tone.

Screw stimulation mode: Constant current, 400V compliance into 4K Ohm load.

Intensity Start: 0.1 - 10 mA.

Intensity End: 1 - 60 mA.

Intensity Step: 1 mA.

Intensity Mode: Automatic.

Stimulation Output: Stim Control.

Monitoring: On-screen display of patient current.

Response Criteria: 3 response replications.

Response Acquisition: Stop after rst valid response or continue to End intensity.

Pass Fail Indicators: Visual: Color.

Audible: Tone.

Nerve Root Test Mode

Acquisition: Stimulus triggered. All data can be saved.

Channels: 8, Independent On/O controls.

N. Root stimulation mode: Constant current, 400V compliance into 4K Ohm load.

Intensity Start: 0.1 - 3 mA.

Intensity End: 1 - 15 mA.

Intensity Step: 0.5 mA.

Intensity Mode: Automatic.

Stimulation Output: Stim Control.

Monitoring On-screen display of patient current.

Response Criteria: 3 response replications.

Response Acquisition: Stop after rst valid response.

Test Indicators: Visual: Color.

Audible: Tone.

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NIM-ECLIPSE™ E4 SD

TOF Test Mode

TOF stimulation mode: Constant current, 400V compliance into 4K Ohm load.

Intensity Mode: Automatic determination of supramaximal threshold.

Intensity Start: 0.1 - 10 mA.

Intensity End: 1 - 80 mA.

Stimulation Output: TOF.

Monitoring: On-screen display of patient current.

MEP Test Mode

MEP stimulation mode: Constant voltage, Fast charge 0-1000V, 1000mA compliance into 1K Ohm load; Slow charge 0-600V, 175 mA compliance.

Pulse Duration: Fast MEP 30 - 75 μs. Slow MEP 100 - 500 μs.

Stimulation Output: MEP.

System Information

Channels: 1.

Display: Trace: Overlapping, time shifted traces for each stimulus in the train with peak markers.

Graphical: Amplitude histogram, TOF ration (%), TOF count (0 - 4).

Channels: 8, Independent On/O controls.

Train Mode: Single, Train, Double Train.

Monitoring: On-screen display of patient current.

D Wave Test Mode

Channels: 1 to 8.

Averaging: Grand averaging.

Markers: Up to 8 per channel.

Speech Mapping Test Mode

Stimulation: High electrical stimulus.

Stimulation output: Stim control and instrumentation.

Monitoring: On-screen display of patient current.

Pulse oximeter: SpO2 from two pulse oximeters displayed on screen (Not approved in Brazil and Canada).

NIM-ECLIPSE™ E4 SD

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System Information

Motor Mapping Test Mode

Acquisition: Stimulus triggered EMG. All data can be saved.

Channels: 8, Independent On/O controls.

Stimulation: High electrical stimulus.

Stimulation output: Stim control and instrumentation.

Monitoring: On-screen display of patient current.

Patient Interface Module

Recording Channels: 8.

Input Modes: Needle or surface electrodes.

Indicators: LEDs indicate active electrode inputs.

Amplier Input: ± 25 mV.

Noise: 20 nV/v Hz 30 - 3000 Hz.

CMRR: > 100 db @ 60Hz.

Impedance: > 100 Mohms.

DC Input: 1.25 V.

Bandwidth: 30 Hz - 4 Khz.

A/D converter: 20 KHs/channel, 16 bit.

Stimulator Outputs: Surgeon controlled probe.

Oximeter: Nonin Xpod™* Patient Cable Oximeter Rev 29+.

Isolation: Optical and Galvanic.

Safety: Meets or exceeds IEC601-1.

Connectors: DIN 42802 touch-proof.

Environmental: Splash proof.

Electried instrument.

Train of Four.

MEP.

Oximeter Inputs: 1 or 2.

Population: Adult, pediatric and neonatal.

Oxygen saturation range: 0 to 100%.

(Not approved in Brazil and Canada)

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NIM-ECLIPSE™ E4 SD

System architecture

Central CPU i5 or higher, 1.4+ GHz, 4GB+ RAM.

Operating system: 64-bit Windows™* 7/10 for System; 32/64-bit Windows™* 7/10 for Reader.

Platform: Desktop or laptop.

Graphics resolution: 1024 x 768 or higher.

Display size: 15” or larger.

EMG speaker: 1 internal.

Mass storage: 64+ GB HDD, R/W DVD.

Printer: Any Windows™* supported printer.

Communications: Network compatible.

Power: 100-240 VAC, 50-60Hz, < 300W.

Operational environment

temperature range:

Operating

Humidity: 30-70% RH non-condensing.

Atmospheric

pressure range:

Mode of operation: Continuous duty.

10 to 40 ºC (Operating).

700 kPa to 1060 kPa.

System Information

Classications

Type of Protection against electrical shock: Class I Medical Device per IEC/EN60601-1.

Degree of protection against electrical shock: Type BF applied parts.

Ingress of water, dust, or solids IEC 60529: IPX0.

Use with ammable anesthetics mixtures, with air,

oxygen, and nitrous oxide:

Power Outlets

System Controller (ECLC/945ECLC): 200VA.

Power Controller (P216, 945P216, P226): 300VA (total combined load from 4 outlets).

Not suitable for use in the presence of ammable anesthetic mixtures and/or oxygen-rich environments.

NIM-ECLIPSE™ E4 SD

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System Information

Guidance and manufacturer’s declaration – electromagnetic emission and immunity

Environment of intended use: professional healthcare facility environment.

Guidance and manfacturer’s declaration - electromagnetic emissions

The NIM-Eclipse™ is intended for use in the electromagnetic environment specied below. The customer or the user of the NIM-Eclipse™ should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emission CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage uctuations/icker emissions IEC 61000-3-3

Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not oer adequate protection to radio‐frequency communication services. The user might need to take mitigation measures, such as relocating or re‐orienting the equipment.

Part I

The NIM-Eclipse™ is intended for use in the electromagnetic environment specied below. The customer or the user of the NIM-Eclipse™ should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8

Note: UT is the a.c. mains voltage prior to application of the test level.

Group 1 The NIM-Eclipse™ uses RF energy only for its internal function. Therefore, its RF emissions are

Class A

Complies

very low and are not likely to cause any interference in nearby electronic equipment.

The NIM-Eclipse™ is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purpose.

Guidance and manufacturer’s declaration – electromagnetic immunity

±8 kV contact ±15 kV air

±2kV for power supply lines ±1kV for input/output lines

±1kV line to line ±2 kV line to earth

0 % UT (100 % dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0 % UT (100 % dip in UT) for 1 cycle at 0°

70 % UT (30 % dip in UT) for 0.5 sec at 0°

0 % UT (100 % dip in UT ) for 5 sec 0 % UT (100 % dip in UT ) for 5 sec

30 A/m 30 A/m

±8 kV contact ±15 kV air

±2kV for power supply lines ±1kV for input/output lines

±1kV line to line ±2kV line to earth

0 % UT (100 % dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0 % UT (100 % dip in UT) for 1 cycle at 0°

70 % UT (30 % dip in UT) for 0.5 sec at 0°

The relative humidity should be at least 5%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the NIM-Eclipse™ requires continuous operation during power mains interruptions, it is recommended that the NIM-Eclipse™ be powered from an uninterruptible power supply or a battery.

Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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NIM-ECLIPSE™ E4 SD

System Information

Part II

Guidance and manufacturer’s declaration - electromagnetic immunities

The NIM-Eclipse™ is intended for use in the electromagnetic environment specied below. The customer or the user of the NIM-Eclipse™ should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test level Compliance level Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

3Vrms 150kHz to 80MHz 6 Vrms 150 kHz to 80 MHz in ISM bands

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the NIM-Eclipse™, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Radiated RF IEC 61000-4-3

NOTE These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

3V/m 80MHz to 2.7 GHz

9 – 28 V/m Spot frequencies 385 MHz to 5.785 GHz Pulse modulation

3V/m 80 MHz to 2.7 GHz

9 – 28 V/m Spot frequencies 385 MHz to 5.785 GHz Pulse modulation

Portable and mobile RF communications equipment should be used no closer to any part of the NIM-Eclipse™, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = (6/E) √P

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, E is the immunity test levels in volt per meter (V/m), and d is the recommended separation distance in meters (m). Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distances between portable and mobile RF communications equipment and the NIM-Eclipse™

The NIM-Eclipse™ is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NIM-Eclipse™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NIM-Eclipse™ as recommended below, according to the maximum output power of the communications equipment.

Rated maximum power of transmitter

P (W)

380 MHz - 390 MHz d = 0.22√P

430 MHz - 470 MHz d = 0.22√P

Separation distance according to frequency of transmitter meters

704 MHz - 787 MHz d = 0.67√P

800 MHz - 960 MHz d = 0.22√P

1.7 GHz -

1.99 GHz d = 0.22√P

2.4 GHz -

2.57 GHz d = 0.22√P

5.1 GHz -

5.8 GHz d = 0.67√P

0.01 0.03 0.03 0.07 0.03 0.03 0.03 0.07

0.1 0.07 0.07 0.21 0.07 0.07 0.07 0.21 1 0.22 0.22 0.67 0.22 0.22 0.22 0.67 10 0.7 0.7 2.12 0.7 0.7 0.7 2.12 100 2.2 2.2 6.7 2.2 2.2 2.2 6.7 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the

equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

NIM-ECLIPSE™ E4 SD

7-10

System Information

Troubleshooting

For any troubleshooting items not corrected by the actions below, contact Technical Support.

Issue Possible Cause Action

Some or all traces are at Electro surgical cautery (ESU) is in use Wait until ESU stops.

Open or loose electrodes (including patient ground) Verify connectivity of electrodes. Electrodes in wrong pin. Verify the electrodes are in the correct pins Saturated ampliers. Artifact of FSI indicator appears.

Line related artifacts on some or all traces AC operated equipment. Periodic artifacts are caused by AC

Guest (remote PC) unable to connect to Host (NIM-Eclipse™ System Spinal System)

operated equipment. Large power line artifacts (between 100-1000 microvolts) can preclude evoked potential monitoring and must be addressed prior to monitoring.

Electrostatic or Electromagnetic interference Remove power connections from equipment at

ECG contamination due to electrodes being placed over artery or in close proximity to ECG signal

EMG interference or movement artifacts Consult anesthesiologist regarding anesthetic

Wireless connection is o. The PC has a wireless on/o switch on the

Wireless connection is on, but unable to connect to the Internet.

Remote Monitoring is not enabled on the Host. From the Test screen, click the Remote

Unable to connect to IP address after virtual private network is established.

according to the electrode chart.

Use the Raw EMG to view input data so that changes can be seen easily.

the wall outlet. Disconnect power from microscope, electric

operating room table, blood warmer, heating blanket, etc.

Test for faulty AC outlets or excessive leakage current from perioperative equipment. Verify that the system wall power outlet is well grounded.

Use an alternate wall outlet. Connect the system isopotential ground

terminal to a known good ground using a heavy gauge wire to ensure zero voltage dierence between equipment.

Set the Stimulation Rate to a non-integer multiple of the power line frequency, for example 4.3Hz.

Verify electrode impedances are lower than 5K Ohms. Attempt to match impedances to less than 2K Ohms.

Use a large, 2-3 cm² active area electrode for patient ground.

Braid electrode leads to reduce electromagnetic interference.

Minimize electrostatically induced interference by changing the position of the Patient Interface Module and/or electrode leads.

Reposition electrodes on aected channel(s)

agents used Prevent electrode movement by securing to

the patient with tape

front, side, or on the keyboard layout. Conrm that the switch is in the On position.

Click on the Wireless icon on the taskbar to open available network selections. Conrm that the preferred network is selected.

icon on the right side of the screen.

The Remote Monitoring Settings panel appears. Press [Enable Networking] to enable remote monitoring.

Conrm that the 8000 port is open on the rewall for both incoming and outgoing trac.

7-11

NIM-ECLIPSE™ E4 SD

Issue Possible Cause Action

Guest does not have correct IP address. On the Test screen, click the Remote

The system displays the incorrect date / time format on the user interface and on reports.

Excessive stimulus artifact High or unbalanced electrode impedance (may be on

Stimulation not delivered (measured current does not equal set current)

Improper impedance values / failed impedance test

Windows™* is not using the correct region format for date/ time.

stimulation, recording, or ground electrodes)

Stimulation and recording electrodes are overlapping or in close proximity

Electrodes not properly connected If pre-gelled adhesive electrodes are used,

Stimulating electrode or probe connection or contact with tissue

Current shunting Ensure electrode sites are not ooded

Stimulus Mode set to non-repetitive Verify Stimulus Mode setting High electrode impedance (greater than 5K Ohms) or high

electrode imbalance (electrodes are not within 2K Ohms of each other)

System Information

icon on the right side of the screen.

The Remote Settings panel appears. The correct IP address appears in the Remote Hosting section.

Note: If NIM-Eclipse™ E4 System software version is v4.1.410 or lower, update to the latest version. See Technical Support.

Close the NIM-Eclipse™ E4 System software.

In the Windows™* Control Panel, select Region and Language settings.

On the Formats tab, select the appropriate language from the Format list.

On the Location tab, select the appropriate country from the Current Location list.

Click [Apply] and then click [OK].

Restart the NIM-Eclipse™ E4 System Software.

Prep skin at stimulation and recording sites Ensure proper electrodes connections and

placement Verify electrode impedances are lower than 5K

Ohms. Attempt to match impedances to less than 2K Ohms.

Place ground electrode between recording and electrical stimulator electrodes

Increase distance between the recording and stimulation electrode leads. If they must cross, set leads at right angles.

Add Stimulus delay Use Suppress Stimulus to blank out the

stimulus artifact

ensure the gel pads are not contacting each other.

Verify electrode impedances are lower than 5K Ohms. Attempt to match impedances to less than 2K Ohms.

Ensure ush contact between stimulating electrode or probe and nerve

Ensure proper connections and placement

Verify electrode placement

Ensure proper electrodes connections and placement

Prevent electrode movement by securing to the patient with tape

Prep skin at electrode sites Remove and replace with new electrode. If

correcting high imbalance, remove and replace electrode with highest impedance reading rst.

NIM-ECLIPSE™ E4 SD

7-12

System Information

Issue Possible Cause Action

Electrode impedance is too low Ensure positive and negative electrode tips are

Stimulator Error Message Faulty connection between stimulator and controller Check all connections

Stimulus settings exceed built-in safety limits Change stimulus parameters to reduce output

High stimulator electrode impedance Ensure proper electrodes connections and

not contacting each other below surface of skin

Replace stimulator module or cable

energy

placement

7-13

NIM-ECLIPSE™ E4 SD

Symbols

System Information

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See recycling. medtronic.com for instructions on proper disposal of this product.

Equipotential Ground connector

AC Power

Type BF Applied Part

Fuse

Functional earth (ground)

Protective earth

High voltage. Do not use for Trans-Cranial stimulation

Power o / Power on

Follow instructions for use

General warning sign

Warning: Dangerous Voltage

ROHS - Environmental friendly use period - China (SJ/T11364-2006)

NIM-ECLIPSE™ E4 SD

Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1. Certied to CSA C22.2 No.60601-1

7-14

Medtronic Xomed

EC REP

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Canada

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Medtronic NCCPUE4 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual