Medtronic NCCPUE4 Instructions for Use
NIM-Eclipse™ E4 NS
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
Digital Preamplier 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 Sta ...................................................................................................................... ......4-5
Case Details ................................................................................................................. ......4-6
Case Info ....................................................................................................................... ......4-6
Monitored Modalities, Alerts, Alarms................................................................. ......4-7
Create a Patient Prole .................................................................................................... ......4-8
Modify a Patient Prole ................................................................................................... ......4-8
Delete a Patient Prole .................................................................................................... ......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
Predened 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
Predened 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/O ........................................................................................................ ......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 specications .................................................................................................. ......7-3
System overview ....................................................................................................... ......7-3
Digital preamplier module .................................................................................. ......7-3
Digital preamplier 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 im-
munity .................................................................................................................................. ... 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 preamplier module, at the patient location, to minimize interference and improve isolation. High performance
preampliers, 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 exibility, 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 ow 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 signicantly 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 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 Preampliers, 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.
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Introduction
• Practitioner is responsible for proper use, periodic safety certication 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 eective 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 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 amplier (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 ineective 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 qualied service personnel only. Repair and/or modication to the NIM-Eclipse™ System or
any accessory by anyone other than Medtronic qualied service personnel may signicantly compromise the unit’s ability to monitor
nerve activity or expose hazardous voltages.
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Introduction
W28 Use of any accessories, cables and disposables other than those specied 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 eld. The eect 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 oered 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 specically 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 veried. 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 notied 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.
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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 specied 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 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 debrillator-proof. Remove all applied parts from the patient before applying the debrillator.
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 Preamplier 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 aected 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 conguration 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.
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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 preamplier
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 preamplier CPP500AUS/CPP50EUR/CPP50UK/CPP500IND printer
POC180/945POC180 pulse oximetry cable
desktop computer systems)
TC32/945TC32 transporter case
Cables CDAQ916/945CDAQ916 preamplier 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
DME1001, DME2002, DME1004
945DME1001, 945DME2002, 945DME1004
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 NS2-1
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, Digital Preamplier 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.
1. Preamplier A: Connect the DAQ916/945DAQ916 Digital Preamplier
module to the black color-coded connector to Preamplier A.
2. Preamplier B: If a second DAQ916/945DAQ916 Digital Preamplier
module is used, connect the black color-coded connector to Preamplier
B.
3. 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 rst module. Do not
connect the second module to the ECLC.
4. Earphones
5. LED Goggles
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 dierence 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 dierence 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 NS
2-2
Setting up Hardware
Digital Preamplier Module
The DAQ916 Digital Preamplier Module (DPM) provides signal
detection, amplication, montage selection, A/D conversion, antialiasing ltering, 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 dierent 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 dene 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 specic test. Software
controlled electrode switching allows any of thirty-two (32) inputs to be
congured 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 nger 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 ow in extremities
due to eects 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 suciently 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.
NIM-ECLIPSE™ E4 NS2-3
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 veried 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 Denition.
Note: The Title Bar of this message includes a specic 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 recongure 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 dierentiate 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.
NIM-ECLIPSE™ E4 NS
2-4
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 specications.
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 congured 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, 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 eect.
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.
NIM-ECLIPSE™ E4 NS2-5
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
NIM-ECLIPSE™ E4 NS
2-6
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.
NIM-ECLIPSE™ E4 NS2-7
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. Conrm 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 conrmation 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 Preamplier & 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 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 NS
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 Electrodes and 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 Diagnostics
11. Use the Speaker Settings Panel
12. 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-dened 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.
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-dened 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.
4-1 NIM-ECLIPSE™ E4 NS
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. You can review patient tests recorded with the NIM-Eclipse™ NS or NIM-Eclipse™ SD Systems.
Right-click the column headers to show/hide columns.
1. System Menu: Use this menu to access System Info, Help, User’s
Manual, Support, and to Exit 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, Case Info, Case Details and Monitored Modalities, Alerts,
Alarms.
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 NS
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. Use the Add Modality (plus sign) on the modality settings panel to add the desired modalities.
3. Use Modalities Settings to congure parameters for the modalities to be included in the protocol. Refer to the Modality Settings topic for
more information.
4. Click System Menu > Save As to save the protocol.
5. In the Save As window, 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. 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 dened 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 modied and saved with a new name.
• User dened: User dened 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 congure parameters for the modalities to be included in the protocol. Refer to the Modality Settings topic for
more information.
4. Click System Menu > Save As to save the protocol.
5. In the Save As window, 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-dened 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 modied 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 modied in
the Patient Information Panel on the monitoring screen.
4. Click [Ok].
Start/Stop, Stop All, and Pause/Resume Stimulation
• Press the Start/Stop button on the modality window title bar to start/stop recording and stimulation.
• Press the Stop All icon to stop recording and stimulation for all started modalities.
• Press the Pause/Resume icon to pause/resume repetitive or single sequence stimulation for all started modalities. Delivers the next stimulus
when non-repetitive stimulation.
4-3 NIM-ECLIPSE™ E4 NS
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 Stop All
F3 Pause/Resume stimulation, or next stimulus
F4 Impedance
F5 N/A
F6 N/A
F7 Next average
F8 Install baseline
F9 Save screen
F10 Print screen
F11 Speaker On/O
when non-repetitive stimulation. Use Shift+F3 in
simulation mode to simulate 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.
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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 specic 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.
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Creating and Modifying Protocols
Case Details
The Case Details section contains elds for history, pre- and postoperative neuro decit.
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 Monitoring
Start and End when the user starts/stops a modality.
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Creating and Modifying Protocols
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.
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Create a Patient Prole
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 Prole
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 Patient Information panel.
Delete a Patient Prole
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 prole:
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.
Creating and Modifying Protocols
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 [Edit List].
3. Click [Edit Lists].
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