NIM-ECLIPSE E4 NS Users Manual sw ver 4.3 Feb 2021

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 Digital Preamplifier Module... ������2-3 Pulse Oximeter... ������2-3 Electro-Surgery Unit mute probe ... ������2-3 Electrical Stimulator Module... ������2-4 NIM-Eclipse™ System computer... ������2-5 Power Controller Unit... ������2-5 Connecting the system components... ������2-5 Connection guide... ������2-6 NS System Connection Diagram... ������2-6 Powering on the system... ������2-7

Section 3: Quick Start and Stop Quick start procedure... ������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, Stop All, and Pause/Resume Stimulation... ������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 Staff... ������4-5 Case Details... ������4-6 Case Info... ������4-6 Monitored Modalities, Alerts, Alarms... ������4-7 Create a Patient Profile... ������4-8 Modify a Patient Profile... ������4-8 Delete a Patient Profile... ������4-8 Edit Lists... ������4-8 System Settings... ������4-9 General tab... ������4-9 Colors tab... ��� 4-10 Training tab... ��� 4-11 Electrodes and Channels... ��� 4-12 Naming electrodes... ��� 4-13 Assigning channels... ��� 4-13 Sets... ��� 4-14 Stimulating Boxes... ��� 4-14 Modalities... ��� 4-14 EEG... ��� 4-14 Raw EMG... ��� 4-14 Triggered EMG... ��� 4-14 MEP... ��� 4-15 Pedicle Screw... ��� 4-15 Pedicle Tract... ��� 4-15 Nerve Root... ��� 4-16

Neural Proximity... ��� 4-16 Train of Four (TOF)... ��� 4-16 SEP Upper and Lower... ��� 4-16 BAER... ��� 4-16 VEP... ��� 4-16 Other EP... ��� 4-17 Speech Mapping... ��� 4-17 Motor Mapping... ��� 4-17 D Wave... ��� 4-17 Modality Settings... ��� 4-17 Trace Settings... ��� 4-18 Spectral Settings... ��� 4-21 Numeric Settings... ��� 4-22 Markers Settings... ��� 4-22 Stimulus Settings... ��� 4-23 Electrical Stimulus Advanced Settings Window... ��� 4-24 Audio Stimulus Advanced Settings Window... ��� 4-25 Secondary Windows Settings... ��� 4-27 Measured Current - All Stimuli... ��� 4-27 EMG Tests... ��� 4-27 Pulse Oximeter... ��� 4-27 Camera 1 & Camera 2... ��� 4-27 Surgeon Screen... ��� 4-27 Timer 1 & Timer 2... ��� 4-27 Vital Signs... ��� 4-27 Speaker Settings... ��� 4-28 Diagnostics... ��� 4-28 Comments settings... ��� 4-29 System generated comments... ��� 4-29 User entered comments... ��� 4-29 Predefined comments ... ��� 4-29 Auto Comments... ��� 4-29 Show Comments... ��� 4-29 Save... ��� 4-30 Comments File... ��� 4-30 Spectral Settings... ��� 4-21 Numeric Settings... ��� 4-22 Markers Settings... ��� 4-22 Stimulus Settings... ��� 4-23 Electrical Stimulus Advanced Settings Window... ��� 4-24 Audio Stimulus Advanced Settings Window... ��� 4-25 Secondary Windows Settings... ��� 4-27 Measured Current - All Stimuli... ��� 4-27 EMG Tests... ��� 4-27 Pulse Oximeter... ��� 4-27 Camera 1 & Camera 2... ��� 4-27 Surgeon Screen... ��� 4-27 Timer 1 & Timer 2... ��� 4-27 Vital Signs... ��� 4-27 Speaker Settings... ��� 4-28 Diagnostics... ��� 4-28 Comments settings... ��� 4-29 System generated comments... ��� 4-29 User entered comments... ��� 4-29 Predefined comments ... ��� 4-29 Auto Comments... ��� 4-29 Show Comments... ��� 4-29 Save... ��� 4-30 Comments File... ��� 4-30

Section 5: Monitoring and Review NIM-Eclipse™ System Monitoring Screen... ������5-1 System Menu... ������5-2 Layout tabs... ������5-2 Impedances ... ������5-2 Threshold Impedance... ������5-3 Impedance Autochecking... ������5-3 Screenshot capture... ������5-3 Screen and Window customization... ������5-3 Channels On/Off... ������5-4 Include Channels for Autotesting... ������5-4 Dragging Elements in Trace and Stack Windows... ������5-4 Right-click windows menu... ������5-4

Clear Traces... ������5-5 Next Average... ������5-5 Baseline... ������5-6 Reset EP... ������5-6 Cursors dialog... ������5-6 Add alert/alarm... ������5-7 Other right-click options ... ������5-7 NIM-Eclipse™ System Review Data screen... ������5-8 Review a test... ������5-9 Previous/Next arrow control... ������5-9 Play/Stop Playback control... ������5-9 Review test functional keys... ������5-9 Print Settings... ��� 5-10 Output... ��� 5-10 Comment... ��� 5-10 Select Reports... ��� 5-10 Professional report... ��� 5-10 Report Header... ��� 5-10 Legal Notice... ��� 5-10 Report Parameters... ��� 5-10 Export data settings... ��� 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 Create and Edit Report Templates... ��� 5-17 Add Date 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 specifications... ������7-3 System overview... ������7-3 Digital preamplifier module... ������7-3 Digital preamplifier module... ������7-4 Pulse oximeter module (not approved in Brazil and Canada)... 7-4 Evoked potential monitoring... ������7-5 EEG monitoring... ������7-5 EMG monitoring... ������7-5 Speech mapping... ������7-6 Stimulation general... ������7-6 Electrical high level... ������7-6 Electrical slow charge MEP... ������7-6 Electrical fast charge MEP... ������7-7 Pedicle screw integrity... ������7-7 Neural proximity... ������7-8 Electrical low level... ������7-8 Audio... ������7-8 Visual... 7-8 External stimulus trigger output... ������7-9 System architecture... ������7-9 Operational environment... ������7-9 Guidance and manufacturer’s declaration – electromagnetic emission and immunity ... ��� 7-10 Part I... ��� 7-10 Part II... ��� 7-11 Troubleshooting... ��� 7-12 Symbols ... ��� 7-15

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 a multi-functional, thirty two channel monitor designed for intraoperative and ICU applications. The system can be used to simultaneously monitor EEG, evoked potentials (EP) and spontaneous and triggered EMG activity. It is designed to meet the highly demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environment. The system incorporates a graphical, point and shoot style user interface to clearly identify and speed parameter selection. A/D conversion is performed in the digital preamplifier module, at the patient location, to minimize interference and improve isolation. High performance preamplifiers, combined with digital signal processing and statistical testing are used to ensure high quality recorded data. The System incorporates multiple digital signal processors and microcontrollers to enhance product flexibility, response time, and patient safety. All patient connections are both software and hardware protected against faults. Patient data can be reviewed during monitoring and reviewed remotely as well. Data can be saved and printed in a variety of formats including HL7 and faxed or emailed directly.

Indications for use The NIM-Eclipse™ System (NS) is intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient’s neurological and vascular status.

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 (NS) 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 significantly 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, pro convulsant 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 W2

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. 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 field. • 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 Preamplifiers, or recording/stimulating electrodes sites to be flooded 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.

NIM-Eclipse™ E4 NS

1-1

Introduction

• Practitioner is responsible for proper use, periodic safety certification 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 effective 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). 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 fifth 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 flash 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 amplifier (characterized by baseline activity of < 3 µV p-p). • Electrodes not positioned properly in the target muscles • Non-flush 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 field. W15 To avoid the risk of fire or explosion, do not use the NIM-Eclipse™ System in the presence of flammable 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 off in the patient. W19 Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needles to break off 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 ineffective 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 qualified service personnel only. Repair and/or modification to the NIM-Eclipse™ System or any accessory by anyone other than Medtronic qualified service personnel may significantly compromise the unit’s ability to monitor nerve activity or expose hazardous voltages. 1-2

NIM-Eclipse™ E4 NS

Introduction

W28 Use of any accessories, cables and disposables other than those specified 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. 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 field. The effect 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 offered 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 specifically part of the NIM-Eclipse™ System. • Do not place the Power Controller Unit on the floor 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 verified. 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 floor 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 off-the-shelf software without first 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 notified 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. NIM-Eclipse™ E4 NS

1-3

Introduction

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 specified 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. 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 fire 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 defibrillator-proof. Remove all applied parts from the patient before applying the defibrillator. 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 Preamplifier 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 affected 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 configuration 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 NS

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/ NCCPUE4-ES/945NCCPUE4 laptop computer

Cables

CDAQ916/945CDAQ916 preamplifier cable CEEX20/945CEEX20 stimulator cable, 6m

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

CEEX98/945CEEX98 stimulator cable, 2.4m

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

AE102/945AE102 insert earphones

CPC18/CPC19 UK/EU power cord, 6m

VG202/945VG202 LED goggles

CPC16/945CPC16 hospital grade power cord, 15ft

Digital preamplifier module

DAQ916/945DAQ916 digital preamplifier

CPP500AUS/CPP50EUR/CPP50UK/CPP500IND printer power cord, 1.8m

Peripherals

MDP201/945MDP201 ESU mute probe

CUSB6/945CUSB6 printer USB cable, 1.8m

POC180/945POC180 pulse oximetry cable Other

P216/945P216 or P226 power controller (required for desktop computer systems) TC32/945TC32 transporter case

System accessories Disposable subdermal needle electrodes

DSN1260, DSN1299, DSN2260, DSN2280, DSN2299

Direct nerve probes

BNP2001, CNP2001, CNP2002, FTP1001, MNP1001, PSP1000, PSP1001, PSP1002, BNP2002, FTP2001, MNP2001, PSP2000, PSP2001, PSP2002

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

Electrode extenders

DSE0001, DSE0002, DSE0003, DSE0004, DSE0005

Surface electrodes

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

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

PXC2002/945PXC2002

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

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

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

Stimulus dissection instrument

NSD2750, 945NSD2750

Corkscrew electrodes

DME1001, DME2002, DME1004 945DME1001, 945DME2002, 945DME1004

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.

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 off 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 2-1

NIM-ECLIPSE™ E4 NS

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, Digital Preamplifier Module(s), and Electrical Stimulator Module(s).

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. 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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4. 5. 6.

7. 8. 9.

Preamplifier A: Connect the DAQ916/945DAQ916 Digital Preamplifier module to the black color-coded connector to Preamplifier A. Preamplifier B: If a second DAQ916/945DAQ916 Digital Preamplifier module is used, connect the black color-coded connector to Preamplifier B. Stimulator: Connect the EEX901/945EEX901 module red color-coded connector to Stimulator connector. If a second EEX901/945EEX901 module is used, connect the second module to the first module. Do not connect the second module to the ECLC. Earphones LED Goggles ESU Probe: Connect the MDP201/945MDP201 ESU Mute probe to this connector to provide audio muting and pausing of stimulation during electrocautery use. USB Interface: Connect the NIM-Eclipse™ System controller to the computer USB port using the USB jumper cable. Audio Input 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 difference 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 difference can be minimized or eliminated by connecting a heavy gauge wire from the Potential Equalization Terminal to a known high quality earth ground terminal.

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10. 11. 12. 13. 14. 15.

16. 17.

CPU Power Out External Triggered In External Triggered Out 1 External Triggered Out 2 External EMG Speaker 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™*. Fuse: The NIM-Eclipse™ System controller requires two (2) T2.5A250V Type 2 fuses. AC Power In: Connect to AC power source. The NIM-Eclipse™ System operates from 105 – 240Vac, 50 – 60 Hz. Maximum input power is 300VA.

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Setting up Hardware

Digital Preamplifier Module The DAQ916 Digital Preamplifier Module (DPM) provides signal detection, amplification, montage selection, A/D conversion, antialiasing filtering, and digital signal preprocessing. Isolated digital data is routed to the controller, via a 20ft cable, for further processing. The DPM has inputs for remote electrodes and a pulse oximeter. Two DPM’s may be used at different patient locations to provide up to 32 recording channels. The DPM’s are labeled “A” and “B”. An LED will illuminate to indicate the DPM in use. DPM “A” and “B” electrodes are used as inputs to define channels and traces. DPM “A” is used for channels 1 – 16, DPM ‘B” is used for channels 17 – 32. Patient electrode leads are connected to the DPM input pins in accordance with the requirements of the specific test. Software controlled electrode switching allows any of thirty-two (32) inputs to be configured to form up to 16 channels. When two DPM’s are used, a total of 64 inputs are available for up to 32 channels. Each input pin has an LED which will be illuminated when that pin (electrode) is used in the current recording. Note: A patient ground electrode must be used on each DPM if two DPM’s are used in a test.

Pulse Oximeter The DPM accepts input from one disposable pulse oximeter finger or toe sensors. If two DPM’s are used, an additional pulse oximeter input is available. When the pulse oximeters are used, oxygen saturation information is automatically measured and displayed. Oxygen saturation can be helpful to monitor for low blood flow in extremities due to effects 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 automatically mute the EMG speaker audio, preventing unwanted interference. 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 sufficiently 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 software is available for use when you do not have access to the ESU mute probe. To access the internal ESU detection, open the System settings within any of the protocols to toggle the ESU detection.

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Setting up Hardware

Electrical Stimulator Module The system’s electrical stimulator module provides stimulation suitable for peripheral, direct nerve, cortical and slow or fast charge transcranial electrical motor evoked potentials (MEP). A wide variety of triggering modes and pulse outputs are available.

The electrical stimulator is located in the controller. Stimulator outputs are then routed to site selectors located in the EEX901/945EEX901 stimulator extender. The System accepts up to two EEX901/945EEX901 electrical stimulator extenders, designated ESM1 and ESM2. A numeric indicator displays the ESM number. Using two EEX901/945EEX901 extenders, up to 16 high level outputs are available. ESM1 interfaces to the controller stimulator via a 20 ft cable connected to the ESM 1 Input connector. A second extender (ESM2) can be connected via an 8 ft cable from ESM1 output to the ESM2 input connector. Connect the cable to either Input/Output end of the EEX901/945EEX901. The stimulators are electrically isolated from the patient and the outputs are protected by both hardware and software fault detectors to insure patient safety. Patient current is displayed for both constant current and constant voltage stimulation modes. The stimulator extenders are small and lightweight and can be placed at the patient location. The EEX901/945EEX901 provides eight independent high level outputs, paired as left and right, for peripheral nerve stimulation and a low-level output for direct nerve applications. Note: Up to 16 high level and 2 low level outputs are available if two EEX901/945EEX901 Stimulator Extenders are used. The positive (anode) is connected to the red terminal of the site, and the negative (cathode) to the black terminal. EEX901/945EEX901 provides high level outputs to a maximum of 100mA or 400V and low level outputs to 4mA/4V. Stimulus pulse duration is adjustable for the Low and High level outputs, respectively. Stimulus rates can be adjusted for all stimuli. A special MEP stimulation output mode is available using site 4. Output pulses may be either single train or double train.

Stimulator self-test Left, Right and Low output stimulators are independent of one another and are verified for proper operation by comprehensive self-tests prior to starting a test or if a stimulator error was detected. If, for some reason, a stimulator fails the self-test procedure the following message appears: • Please contact Customer Service! Self-test indicates a *** Left *** output failure. If your application allows, you may continue temporarily by modifying the test output from the Stimulator Output Definition. Note: The Title Bar of this message includes a specific code relating to the failure. Please make note of this when contacting technical support. If the result indicates that one output has failed you may have the option to temporality reconfigure your test protocol and complete the monitoring procedure. To do so, press OK to continue and change all Stimulus Name references from the failed side to operational side, for example, from Left 1 to Right 3. Save the Test Protocol with a new name to differentiate it from the original. The system will then check your protocol to insure that all Stimulus Names have been changed as described above and, if not, display an error message indicating those Names requiring a changed stimulus output site.

Stimulator error messages The stimulators communicate with the main console using a digital serial link. If communications are interrupted, the following error message will appear: • Electrical Stimulator Extender Module not found. Check Connections or replace module. In most cases this error is caused by a faulty connection at the stimulator or console or an electrical disturbance. Check the connections or replace the stimulator module or cable. If the problem persists, contact Medtronic. The Electrical Stimulators provide built-in safety mechanisms to insure patient safety. The following error message will appear when the stimulator detects an internal or external fault: • Electrical Stimulator Module Error.

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Setting up Hardware

The error message will be displayed for three possible reasons: • The stimulus settings exceed the built-in safety limits. - Change the stimulus parameters to reduce the output energy. For example, reduce Stimulus Intensity, Pulse Duration or Stimulus Rate. If train stimulation is used, reduce the Train Count. • Check for high stimulator electrode impedance. - Reapply or change the electrodes if necessary. • The stimulator module or stimulator cable is faulty. - Replace the defective component and retry.

Audio stimulators The System can produce various auditory stimuli to either intraoperative ear insert. Auditory stimulation may be tone bursts, over a wide range of frequencies and envelopes, or square wave clicks. The stimulus intensity foam ear insert can be varied. Broadband uniform masking noise is also available.

Visual stimulators High intensity LED goggles provide visual stimulation. The applied stimulation may be unilateral, or bilateral, with relative intensity level control.

External trigger outputs The System provides two external trigger outputs which can be used to trigger an external stimulator. The output trigger is a positive true, 100µs wide, TTL compatible pulse derived from BNC connectors located on the Main Unit connector slots.

Vital signs monitor The system can be connected to an external Vital Signs Monitor (VSM) to display certain measurements along with the neurological data. Use this information to correlate changes in the neurological data with ongoing vital signs. The VSM communicates with the System via the serial port. Connect the VSM to the Serial port of the desktop, or to the serial port or serial port adapter of portable computer. A list of supported vital signs monitors is provided in the Secondary window settings section.

Microscope view or video camera input The operator may display the surgeon’s microscope view or video from a camera on the screen along with the monitored data. Connect video to the USB video adapter. Plug the USB plug into any available USB connector of the computer.

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 specifications.

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 configured 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.

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, fluorescent 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 effect. 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/Off 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.

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Setting up Hardware

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.

NS System Connection Diagram

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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 five seconds, press the power button on the computer.

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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 flexibility 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. Confirm the Operator name on the NIM-Eclipse™ System splash screen, then click [NS]. 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 confirmation 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. Connect appropriate disposables, such as electrodes, to Digital Preamplifier & Stimulator modules. 8. Click the Impedances icon. 9. Verify impedances and electrode placement on the patient. 10. Click [Close] at the bottom of the Impedances window. 11. As necessary, use the icons on the right side of the screen to modify settings while monitoring. 12. Press F1 to open system help. 13. Click [Save] to save the Protocol.

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 off the computer. 5. Turn off the power of the NIM-Eclipse™ System controller. 6. Turn off the NIM-Eclipse™ System Power Controller Unit (desktop version only).

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Section 4: Creating and Modifying Protocols

In this section, you will be able to: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Understand NIM-Eclipse™ System screens Use the Patient Information Panel Use the System Settings Panel Understand Electrodes and Channels Create a Protocol Modify a Protocol Use the Modalities Settings Panel Use the Stimulus Settings Panel Use the Secondary Windows™* Settings Panel Use Diagnostics Use the Speaker Settings Panel Use the Comments Settings Panel

Creating and Modifying Protocols

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

1.

System Menu: Use this menu to access System Info, Help, User’s Manual, Support, and to Exit 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. 10. Modify Protocol: Allows users to modify protocols from a list of saved protocols. 11. New Protocol: Allows users to create/save new protocols.

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12. 13. 14. 15.

Remote View: Allows users to enable remote networking. Review Test: Shows list of saved procedures available for review. Resume Test: Allows users to resume a test/procedure. 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-defined 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.

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