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THE NEUROSIGN

INTRAOPERATIVE NERVE MONITOR

PRESERVING NERVE INTEGRITY

User Manual

NOP08-EN-10

March 2021

2797

Summary of Contents for NEUROSIGN V4

Page 1: ...THE NEUROSIGN V4 INTRAOPERATIVE NERVE MONITOR PRESERVING NERVE INTEGRITY User Manual NOP08 EN 10 March 2021 2797...

Page 2: ...t time of publication Company details Neurosign The Magstim Company Limited Spring Gardens Whitland Carmarthenshire SA34 0HR Website https www neurosign com Product Enquiries Telephone 44 0 1994 24079...

Page 3: ...The Magstim Company Ltd iii NOP08 EN 10 Welcome to the Neurosign V4 Intraoperative Nerve Monitor...

Page 4: ...The Magstim Company Ltd iv NOP08 EN 10 Page intentionally left blank...

Page 5: ...o provide information on the configuration operation and maintenance of the nerve monitor The Neurosign V4 Assembly Guide NOP18 EN and Reference Guide NOP19 EN are also available for reference It is i...

Page 6: ...The Magstim Company Ltd vi NOP08 EN 10 Page intentionally left blank...

Page 7: ...4 4 Home Screen 41 4 5 Quick Start Session default 42 4 6 In Surgery 43 4 7 Advanced Features 48 4 8 Reconfiguring Channels 54 4 9 Pre Amplifier Replacement 55 4 10 Patient Reports 56 4 11 Settings 6...

Page 8: ...The Magstim Company Ltd viii NOP08 EN 10 Page intentionally left blank...

Page 9: ...r Pod P N 4440 00 Neurosign V4 Pre amplifier 4 Channel P N 4444 00 Neurosign V4 Pre amplifier 8 Channel P N 4448 00 Neurosign V4 Mute Sensor P N 4225 00 Note Disposables that are compatible are listed...

Page 10: ...The Magstim Company Ltd 10 NOP08 EN 10 Page intentionally left blank...

Page 11: ...promptly with the transportation company All correspondence concerning the equipment must specify the model name and or number as well as the serial number exactly as they appear on the equipment invo...

Page 12: ...The Magstim Company Ltd 12 NOP08 EN 10 Page intentionally left blank...

Page 13: ...The Magstim Company Ltd 13 NOP08 EN 10 SECTION 1 PRODUCT OVERVIEW...

Page 14: ...monitor allows for substantial personalisation of its functions which can be saved in personalised surgeon profiles with customised procedure settings All functions and settings are controlled via th...

Page 15: ...o the upper and lower extremities e g tethered cord pedicle screw procedures cauda equina c Contraindications The nerve monitor is contraindicated for use with neuromuscular blocking agents that will...

Page 16: ...ds to mute the EMG audio 4 USB Export Import The USB memory stick connection for import export provided with a rubber cover See page 24 for more information 5 Stimulator STIM 2 Dial Not currently avai...

Page 17: ...ction Connectionsocketforthepre amplifier lead 13 Slave Screen Connection For more information contact the product enquiries team page ii 14 Display Connection a Touch Screen DCU b Mains unit The conn...

Page 18: ...The Magstim Company Ltd 18 NOP08 EN 10 Page intentionally left blank...

Page 19: ...The Magstim Company Ltd 19 NOP08 EN 10 SECTION 2 ACCESSORIES...

Page 20: ...nel four orange 23 Reference Electrode Channel The corresponding sockets for the reference electrode channel green 24 Electrode Channels 5 8 The corresponding sockets for channel five grey channel six...

Page 21: ...lator Pod Socket The stimulator pod connection lead should be attached to the pre amplifier socket see page 20 Primary Stimulator Sockets Stimulator Pod Socket Mounting Clip 27 28 29 2 3 Mute Sensor I...

Page 22: ...trodes Part number Description Box of 4469 00 2 Channel Electrode Set 10 4470 00 4 Channel Electrode Set 10 4472 00 8 Channel Electrode Set 5 1705 00 Reference Electrode 20 Surface Electrodes Part num...

Page 23: ...use of a return electrode 10 Stimulating Instruments Part number Description Box of 4003 00 Triple Hook Paediatric Probe 1 4009 00 Double Hook Paediatric Electrode 1 4012 00 Ring Dissector requires th...

Page 24: ...basic USB 2 0 memory stick is compatible with the nerve monitor Do not attempt to connect any other devices the USB ports are protected and will not support unauthorised devices Attempting to connect...

Page 25: ...The Magstim Company Ltd 25 NOP08 EN 10 SECTION 3 WARNINGS SYMBOLS...

Page 26: ...ent and result in improper operation WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to an...

Page 27: ...as this may cause damage In the event of hardware failure or software corruption the nerve monitor is designed to fail in a safe state In this state the stimulator and EMG audio channels are disabled...

Page 28: ...s far as possible from the electrode leads Patients with active medical devices such as pacemakers or cochlear implants should not be stimulated using the stimulating probe without due consideration b...

Page 29: ...s Manufacturer see page ii for contact details SN Product serial number REF Product reference number Date of manufacture DO NOT dispose in general waste Please contact the Magstim Company Ltd for advi...

Page 30: ...td 30 NOP08 EN 10 Trigger output socket see page 17 Trigger input socket see page 17 Mute sensor socket see page 17 Ethernet socket see page 17 Stimulator pod to pre amplifier connection see page 20 U...

Page 31: ...assword INFORMATION PROMPT RESTORE LAST SESSION page 41 NEXT PROCEED BACK PREVIOUS ACCEPT CANCEL EDIT SYSTEM RESTART This indicates the system is restarting SOUND MUTED VOLUME EMG AUDIO DISABLED page...

Page 32: ...FREQUENCY PULSE WIDTH ii Settings See 4 11 Settings on page 61 for more information SET TIME AND DATE SET TIME ZONE KEYBOARD SETUP BLUETOOTH DISCOVERY PAIR WITH BLUETOOTH DEVICE REMOVE BLUETOOTH PAIR...

Page 33: ...DURE MONITORING NOTCH FILTER WAVEFORM SETTINGS WAVEFORM THRESHOLD STIMULATION ARTEFACT REJECTION SAR FILTER WAVEFORM SCALE TIMEBASE SCALE CHANNEL ON OFF ARTEFACT REJECTION FILTER EDIT FIELD ENTER TEXT...

Page 34: ...NOP08 EN 10 vi Reporting See d Exporting Reports on page 59 for more information ATTACH DETACH EVENT TO EXPORT EXPORT AS PDF EXPORT AS BMP EXPORT AS CSV PRIMARY STIMULATOR SECONDARY STIMULATOR PROCED...

Page 35: ...The Magstim Company Ltd 35 NOP08 EN 10 SECTION 4 INSTRUCTIONS FOR USE...

Page 36: ...V4 Assembly Guide NOP18 EN Additional copies are available at neurosignsurgical com or from your Neurosign representative see page ii Important Before use please make sure you have read and understood...

Page 37: ...oth Setup on page 63 for information on Bluetooth pairing If you press NO this can be setup at a later time The nerve monitor is now ready for use and will present the home screen Please familiarise y...

Page 38: ...stimulator pod lead into the socket on the stimulator pod 29 right and connect the other end to the socket on the pre amplifier 25 right 25 Stimulator Pod Socket 22 Electrode Channels 1 4 24 Electrod...

Page 39: ...8 Lockable Wheels 7 Storage Pocket 6 Stimulator STIM 2 Dial 5 USBExport Import 4 ScreenTilt Adjust 17 Ethernet Socket 16 Mute Sensor Socket 15 Display Connection a 14 SlaveScreenConnection 13 Pre Ampl...

Page 40: ...n test a prompt will ask Do you wish to proceed with monitoring disabled Note If audio is disabled following audio test failure no EMG audio will be output and the following icon will display in place...

Page 41: ...e screen In subsequent uses the option is given to restore the last session below with a description of the profile and procedure used Figure 4 2 Restore last session Selecting this will re load the s...

Page 42: ...n profile will also allow custom procedure settings to be saved On the Home screen select Select Default and press Select a surgical procedure and press Press to perform the electrode impedance check...

Page 43: ...gs b Trigger Mode d Figure 4 3 Active monitoring screen 4 Channel Procedure a Session Details The surgeon profile patient name and procedure setup name are displayed in the top left hand corner b Filt...

Page 44: ...rsors if shown This will be automatically saved Events must be captured and annotated whilst monitoring is active Not available in default mode see page 42 LATENCY CURSORS Show or hide the latency cur...

Page 45: ...imulator dial 1 page 16 i Stimulator confirmation When the stimulating probe is used the stimulator indicator will change to green as below and a warble tone will sound to confirm that the set current...

Page 46: ...played signal which has exceeded the waveform threshold 5 Timebase Scale Thesetscaleoftimecurrentlydisplayed on the screen X axis To adjust the scale press in the monitoring menu then press or to adju...

Page 47: ...cator will show to the left of each channel window as can be seen below Green indicates the impedance is good Amber indicates the impedance is adequate but not ideal Red indicates the impedance is poo...

Page 48: ...protection passwords are non recoverable Service representatives are not able to recover profiles or the patient data associated with them Unfortunately if a password is forgotten that profile will b...

Page 49: ...be edited by pressing To edit an existing procedure setup select the procedure and press a default procedure setup cannot be edited and should be duplicated first Note Procedures shown with the symbol...

Page 50: ...he maximum stimulation current for the procedure For safety reasons default procedures have built in maximum values that cannot be exceeded Trigger frequency Hz Set to either 30Hz or 3Hz Pulse Width D...

Page 51: ...anywhere within the channel window if the amplitude of the signal is greater than the set threshold value Stimulator The waveform screen will trigger on the first confirmed stimulator pulse see i Sti...

Page 52: ...filter ON or OFF Adjust the sensitivity using the or SAR Stimulator Artefact Rejection SAR filter The SAR filter removes the stimulus click wherever the stimulating probe is touched Toggle the SAR fil...

Page 53: ...n one Neurosign V4 Intraoperative Nerve Monitor is used the relevant profiles can be copied between machines using USB memory stick see a USB on page 24 To export a profile Insert the USB memory stick...

Page 54: ...edure before surgery which is not supported by the connected 4 channel pre amplifier as standard Note In cases where the monitoring is active follow the instructions in section 4 9 Select or create a...

Page 55: ...i e 8 to 4 the screen below will be shown Figure 4 10 Monitoring Pre Amplifier Replaced In this case it is not necessary to match the channel colours Instead connect the required electrodes into any a...

Page 56: ...rgery reports the patient details must be entered A procedure summary can now be added in the procedure summary box e g Exploration of right ear for cholesteatoma Press to save the settings b Events S...

Page 57: ...rom the monitoring menu Reports accessed from the report management screen are read only To access the report management screen From the home screen press Scroll up or down under the Surgeon Procedure...

Page 58: ...ent if entered during monitoring 5 Expand See the selected event in a larger view 6 Attach Attach the selected event to the patient report for exporting Only attached events will be exported along wit...

Page 59: ...B on page 24 Insert the USB memory stick into the USB port 4 page 16 Press to export to the USB memory stick Select the required file type Once the importing icon has gone the USB memory stick may be...

Page 60: ...s expected that the internal memory can store in excess of 100 000 events it is advised that periodic exporting of patient records be carried out at least once a year to protect from accidental data l...

Page 61: ...luetooth setup see c Bluetooth Setup on page 63 USB profile import see d Transferring Profiles on page 53 USB profile export see d Transferring Profiles on page 53 System details access the unique dev...

Page 62: ...ancel Keyboard setup press the flag to choose the keyboard layout b System Settings Screen brightness 0 100 System volume 10 100 Set the maximum volume for the system tones i e keyboard tones stimulat...

Page 63: ...e c Bluetooth Setup ThenervemonitoriscapableofpairingtocertaindevicesviaBluetooth creatingatwo node IT network to allow reports to be exported wirelessly This type of connection could result in unfore...

Page 64: ...g files iii Compatible devices If exported as a pdf a pdf viewer is required on the device in order to view the file The Bluetooth capability of the nerve monitor is currently only available for the f...

Page 65: ...The Magstim Company Ltd 65 NOP08 EN 10 SECTION 5 TROUBLE SHOOTING...

Page 66: ...ms of the same priority will be cycled through with each alarm being reported Further information on each alarm priority is shown below More detailed information on specific errors and alarms can be f...

Page 67: ...nto the external USB port right and press This information can then be sent to the relevant service provider for further evaluation 5 3 System Alarms Messages Banner Message Action Check Electrode Con...

Page 68: ...can be found on page ii System Audio Error If necessary you can continue with audio disabled by pressing YES when prompted See b Connection Audio Test on page 40 for more information Alternatively sw...

Page 69: ...fier Reconnect the stimulator pod if the error remains contact your service provider Contact details can be found on page ii Battery Voltage Low Contact your service provider to replace the internal b...

Page 70: ...seconds and switch the nerve monitor back on Wait for the nerve monitor to perform the connection audio test If the error returns contact your service provider Contact details can be found on page ii...

Page 71: ...rear of the base and that the power switch and mains plug switch are on Display connection cable is not properly connected Check the cable is properly connected and secured at both ends see 1 4 Rear V...

Page 72: ...channel window see page 46 Press the channel volume and use the slider to increase Silence when stimulating the device has not detected any voltage in the muscle the muscle has not contracted The musc...

Page 73: ...w Problem Cause Action Pre amplifier offline lost connection The pre amplifier is either not connected or there is a problem with the connection If you are not currently monitoring you can continue wi...

Page 74: ...The Magstim Company Ltd 74 NOP08 EN 10 Page intentionally left blank...

Page 75: ...The Magstim Company Ltd 75 NOP08 EN 10 SECTION 6 CARE MAINTENANCE...

Page 76: ...ith hospital protocol The Magstim Company Ltd recommends that a lint free cloth moistened with 70 isopropyl alcohol should be used Care must be taken to ensure the equipment is not soaked and has drie...

Page 77: ...resents a serious threat of electric shock and immediate risk to the user Any attempt to remove the security screws will invalidate the product guarantee Performance verification should be carried out...

Page 78: ...e of the equipment would make repair or servicing uneconomic If for any reason it is necessary to return the nerve monitor or accessories care should be taken to ensure that the equipment is adequatel...

Page 79: ...The Magstim Company Ltd 79 NOP08 EN 10 SECTION 7 TECHNICAL INFORMATION...

Page 80: ...further equipment Only equipment that meets the relevant IEC standards and is configured in compliance with IEC 60601 1 should be connected to the nerve monitor c Degree of protection provided by enc...

Page 81: ...nse audio volume Master Volume External connections EMG Amplifier Module Pre amplifier Trigger In Trigger Out Open Drain Mute sensor USB EMG Audio 8 4W rms 95dBa 1m b Stimulator pod Primary Stimulator...

Page 82: ...z 3dB points Noise 20 V rms Input referred Notch filter 50Hz 60Hz off 7 3 General Specification Power 100V 230V 50 60Hz 75VA Dimensions 790mm wide 400mm deep 1600mm high Weight 24Kg Maximum load permi...

Page 83: ...ls screen 1 Serial Number The product serial number 2 Reference Number The product reference number 3 Date Of Manufacture The date this product was manufactured 4 Base Unit The details for the product...

Page 84: ...cy current through a local area of tissue Electrode A conductor through which electricity enters or leaves an object substance or region EMG Electromyography EMG the electrical activity of muscles Mon...

Page 85: ...Variant English US NOP08 PTbr Manual do usu rio do Neurosign V4 Portugu s Brasil NOP08 ES Manual del usuario de Neurosign V4 Espa ol NOP08 FRca Manuel d utilisation Neurosign V4 Fran ais Canadien Supp...

Page 86: ...www neurosign com The Magstim Company Ltd...

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