MAGSTIM NEUROSIGN V4 User manual

THE NEUROSIGN V4
INTRAOPERATIVE NERVE MONITOR
PRESERVING NERVE INTEGRITY
Service Manual
NOP20-EN-03
January 2021
2797

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Magstim® and Neurosign® are registered trade marks of The Magstim Company Ltd.
This document, and all other versions there of, remain property of the Magstim Company Ltd.
and should not be modified of copied without first obtaining permission from the company.
The information contained within this document was accurate at time of publication.
Company details
Neurosign®
The Magstim Company Limited
Spring Gardens, Whitland,
Carmarthenshire, SA34 0HR
Website: http://www.neurosignsurgical.com
Product Enquiries
Telephone: [phone]
Fax: [phone]
E-mail: [e-mail]
Servicing Enquiries
Telephone: [phone]
E-mail: servic[email protected]om
Sales Enquiries
Telephone: [phone]
Fax: [phone]
E-mail: [email protected]om
Authorised Representative in the European Community:
Technomed Europe
Amerikalaan 71, 6199 AE Maastricht-Airport,
The Netherlands
Tel: [phone]

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The Neurosign®V4 Intraoperative Nerve Monitor is a Neurosign Surgical product
which belongs to the Neurosign®division of the Magstim Company Limited.
This service manual has been written to provide information on how to service and
maintain the Neurosign®V4 Intraoperative Nerve Monitor.
!Note: Any modifications, repairs or servicing of the products, named in this manual
or otherwise, not carried out by The Magstim Company Limited or persons authorised
by the company will invalidate the product guarantee.
Within the guarantee period you are advised to contact the Magstim service
department for any servicing or repairs. Contact details can be found on page ii.
For more information on the product guarantee see page 9.
Tools required
The following tools may be required in order to assemble, disassemble and service
the Neurosign®V4 Intraoperative Nerve Monitor.
Pozi drive No. 1
3mm
5mm
Preface

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Company details ii
Preface iii
Tools required iii
Devices covered 7
Product Guarantee 9
PRODUCT OVERVIEW 11
1.1 Front View 12
1.2 Rear View 13
1.3 Pre-Amplifier 14
1.4 Stimulator Pod 15
WARNINGS & SYMBOLS 17
2.1 Warnings & Precautions 18
2.2 Device symbols key 21
ASSEMBLY & DISASSEMBLY 23
3.1 Assembly 24
3.2 Disassembly 26
CARE & MAINTENANCE 29
4.1 Cleaning & Disinfecting 30
4.2 Storage & Environment 30
4.3 User Maintenance & Calibration 30
4.4 Servicing & Device Lifetime 31
4.5 Packaging & Transportation 32
4.6 Decommissioning 32
SERVICING 33
5.1 Testing Requirements 34
5.2 Battery Replacement 34
5.3 Software Upgrade 35
5.4 Keyboard Installation 41
5.5 Device Schematics & Drawings 42
TECHNICAL INFORMATION 43
6.1 Safety Specification 44
6.2 Technical Specification 45
6.3 General Specification 46
6.4. System Details 47
Document Version/s 49
Contents

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This service manual is applicable to the following devices:
Neurosign®V4 Intraoperative Nerve Monitor - P/N: 4230-00
(Referred to as 'nerve monitor')
Accessories:
Neurosign®V4 Stimulator 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: Full information regarding consumables such as stimulating probes and
electrodes are not included in this document. Documentation regarding consumables
is provided along with the item/s. Alternatively documentation can be obtained on
request from your Neurosign®representative.
Devices covered

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Product Guarantee
The Magstim Company Ltd. guarantees the effectiveness of both materials and
workmanship for a period of two years from the date of shipment for the following
products:
Neurosign®V4 Intraoperative Nerve Monitor - P/N: 4230-00
Neurosign®V4 Stimulator 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
The Magstim Company Ltd. reserves the right to perform guarantee services in its
factory, at an authorised repair station, or at the customer’s installation at the
discretion of the company.
The Magstim Company Ltd. guarantees to repair or replace defective equipment or
parts, free of charge within the guarantee period, provided that the said defects occur
during normal use. Replacement will be only at the company's discretion where a
repair is not possible and/or not feasible.
Disposables such as batteries, electrodes and stimulating probes are not covered
under this guarantee.
Claims for damages during shipment must be filed 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 invoice/unit.
Improper use, mishandling, tampering with, or operation of the equipment without
following operating instructions will void this guarantee and release The Magstim
Company Ltd. from any further obligations under this guarantee.
The Magstim Company Ltd. will accept responsibility for effects on safety, reliability
and performance of the equipment provided:
• Any modifications, repairs or servicing of the products are carried out by The
Magstim Company Limited or persons authorised by the company;
• The electrical installation of the relevant room complies with local regulations
and;
• The equipment is used in accordance with the user manual.
The Magstim Company Ltd. guarantees to support the products stated above for a
period of seven years from date of shipment and where the terms of this guarantee
have been met. Servicing and replacement parts will be available within this time.
The Magstim Company Ltd. cannot guarantee that spare parts will be available
after this time. Please see "4.4 Servicing & Device Lifetime" on page 31 for more
information.

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SECTION 1
PRODUCT OVERVIEW

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1.1 Front View
Touch
Screen DCU
2.
Master
Volume Dial
3.
Stimulator
(STIM 1) Dial
1.
Storage
Drawer
9.
Mains
Unit
8.
Lockable
Wheels
7.
Storage
Pocket
6.
Stimulator
(STIM 2) Dial
5.
USB Export
/ Import
4.
1. Stimulator (STIM 1) Dial
This controls the current/voltage for
the primary stimulating probe/s
2. Touch Screen DCU
The majority of the functions are
selected via the touch screen DCU
(Display Control Unit).
3. Master Volume Dial
Rotate the dial clockwise to increase
the volume, anticlockwise to decrease
the volume. Press and hold for 2
seconds to mute the EMG audio.
4. USB Export/Import
The USB memory stick connection for
import/export, provided with a rubber
cover
5. Stimulator (STIM 2) Dial
Not currently available. For more
information contact the product
enquiries team (page ii).
6. Storage Pockets
The nerve monitor houses a ‘pocket’
on either side of the unit to safely store
the pre-amplifier and the stimulator
pod. The 'pockets' are fully removable
to facilitate cleaning.
7. Lockable Wheels
The wheels allow the nerve monitor
to be moved around i.e. between
theatre's. To lock the wheels, press
down on the tab for each wheel.
8. Mains Unit
The mains unit houses the power
supply and speaker.
9. Storage Drawer
The storage drawer is designed
to accommodate and store the
disposables.

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1.2 Rear View
Screen Tilt
Adjust
17.
Ethernet Socket16.
Mute Sensor Socket15.
Display Connection (a)14.
Slave Screen Connection13.
Pre-Amplifier
Connection
12.
Trigger
Output
11.
Trigger
Input
10.
Power
Switch
20.
Power
Input
19.
Display
Connection(b)
(14.)
Equipotential
Point
18.
10. Trigger Input
Connect an external stimulator trigger
to this connector. This requires a TTL 5V
pulse.
11. Trigger Output
The output is a TTL 5V signal at the
same frequency as the stimulator.
12. Pre-Amplifier Connection
Connection socket for the pre-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 connection between the touch
screen DCU and the mains unit via the
UI cable.
15. Mute Sensor Socket
Connection socket for the mute sensor
lead.
16. Ethernet Socket
For more information contact the
product enquiries team (page ii).
17. Screen Tilt Adjust
Refer to the operating manual for
information.
18. Equipotential Point
See "a. Electrical Testing" on page 31
19. Power Input
Connection socket for the AC mains
power lead provided with the nerve
monitor.
20. Power Switch
The switch to turn the nerve monitor
ON and OFF.

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1.3 Pre-Amplifier
The pre-amplifier collects the EMG signals from the electrodes and amplifies them
for processing and display.
The pre-amplifier is available in a 4-Channel or 8-Channel variant.
21. Mounting Clip
A mounting clip is located on the side of the pod so that it can be attached to the
side rail of the operating table.
22. Electrode Channels 1 - 4.
The corresponding sockets for channel one (blue), channel two (red), channel three
(violet) and channel 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 (yellow), channel seven
(brown) and channel eight (cream). These are unique to the 8-Channel pre-amplifier.
25. Stimulator
Pod Socket
26. Pre-Amplifier
Connection Lead
22. Electrode
Channels 1 - 4
24. Electrode
Channels 5 - 8
23. Reference
Electrode
Channel
21. Mounting
Clip
25. Stimulator Pod
Socket.
Plug the stimulator pod
connection lead into here.
26. Pre-Amplifier
Connection Lead.
Connect the other
end of this lead to the
corresponding socket
on the rear of the touch
screen DCU (see page
13).

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1.4 Stimulator Pod
The stimulator pod serves as a connection point for the stimulating probes and allows
for two stimulating probes to be connected simultaneously. This can be useful when
both precise and wide-field stimulation is required. The stimulator pod also serves to
reduce the length of cable attached to the stimulating probes, making them easier
to handle.
27. Mounting Clip
A mounting clip is located on the side
of the stimulator pod so that it can be
attached to the side rail of the operating
table.
28. Primary Stimulator Sockets
The primary stimulating probes should
be connected into the corresponding
coloured sockets.
29. Stimulator Pod Socket
The stimulator pod connection lead
should be attached to the pre-amplifier
socket (see page 14).
Primary
Stimulator
Sockets
Stimulator
Pod Socket
Mounting
Clip
27.
28.
29.

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SECTION 2
WARNINGS & SYMBOLS

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2.1 Warnings & Precautions
• Failure to heed the following warnings and precautions may cause damage to the
equipment and render the equipment unusable or dangerously unsafe.
• The Neurosign®V4 Intraoperative Nerve Monitor is designed for use during surgical
procedures and must only be used by trained personnel who have carefully studied
this User Manual.
• Electromagnetic compatibility (EMC): This Neurosign V4 complies with IEC
60601-1-1:2014, Edition 4.0 (Conducted and radiated emissions comply with CISPR
11 Group 2 Class A limits and immune to the Professional Healthcare Environment).
The Neurosign V4 also complies with IEC 60601-2-40:2016 regarding compatibility
for use alongside HF Surgical Equipment.
WARNING: Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment 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 any part of the Neurosign V4, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
NOTE: The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-orienting
the equipment.
Please be aware: It is not possible to test all sources of RF interference.
Consequently, if you experience any unexpected operation from the Neurosign®
V4, isolate the device from any surrounding portable and mobile radio frequency
communications equipment. If incorrect operation continues, please contact
Magstim using the contact details on page ii.
• Excepting those stated in "4.3 User Maintenance & Calibration" on page 30, no
user-serviceable parts are found within the Neurosign®V4 Intraoperative Nerve
Monitor. Please refer to page 30 for proper Care and Maintenance information.
• Opening the case presents a serious threat of electric shock and immediate risk
to the user.

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• Any attempt to remove the securing screws will invalidate the product guarantee.
• No unauthorised modifications may be made to the nerve monitor or any of its
associated accessories.
• CLASS I: Equipment must only be connected to an AC mains supply with protective
earth. Connection should only be made with the power lead provided with the
equipment.
• This device is designed as an aid to surgeons in the identification and monitoring
of nerves at risk of injury during surgery. It is not a replacement for surgical
experience.
• Do not use this equipment in the presence of flammable anaesthetic mixtures.
• Handle with care. Dropping this device or any accessories may cause physical
damage and affect performance.
• Ensure that the mains plug and socket are readily accessible to provide isolation
from the supply mains if necessary.
• Do not permit liquid close to the ventilation slots in the bottom of the casing.
• Do not insert objects into connector housings, holes or slots in the casing for
cleaning purposes, 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.
• Do not connect the mute sensor to the nerve monitor without attaching the clamp
to the electrocautery cable or spurious muting of the nerve monitor may occur.
• When a mute sensor is connected and active, the stimulator current confirm will
not be reported.
• High levels of radio frequency (RF) may interfere with the operation of the mute
sensor if the device is not connected to the electrocautery cable.
• Care should be taken to avoid the tip of the stimulating probe coming into contact
with that of the electrocautery probe, this will cause damage to the internal
circuitry of the nerve monitor.
• The use of this device other than as described will reduce the level of protection
provided by the equipment. If it is deemed necessary to use the device in any
way other than as stated in this document it is strongly advised to contact The
Magstim Company Ltd. for advice before use.
• During use, the nerve monitor will have a number of leads/cables connected.
Therefore, care should be exercised with lead/cable placement to avoid a tripping
hazard.

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• Under extreme conditions it may be possible that the mute sensor, pre-amplifier
or the stimulator pod are affected by RF. In this case, the offending piece of
equipment should be identified and replaced. Alternatively, an improvement may
be achieved by moving the pre-amplifier, stimulating pod, associated cables, or
changing the position of the mute sensor.
• Incorrect needle placement or faulty electro-surgical equipment has the potential
to cause burns at the point of contact between the needle electrodes and tissue.
It is therefore strongly recommended that instructions are strictly adhered to, and
that the equipment is regularly checked and serviced.
• The possible risk of burns caused by interaction between the electrosurgical
machine and the monitor should be a factor in balancing the risks associated
with the surgery.
• In order to reduce possible induced current in needle electrode leads (caused by
stray RF emitted by the electro-surgical unit), the electrode leads should be kept
as far as possible from the electro-surgical unit.
• Cables from the electro-surgical unit, both active and return, should also be kept
as 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
being given to the risks involved. Current must not pass across the heart or the
implanted device. The use of bipolar probes will greatly reduce any possible current
spread. If used, keep the current to the minimum needed to stimulate the nerve.
• Leads or equipment which do not comply with IEC 60601-1 should not be
connected to the nerve monitor (and accessories), or plugged into the connection
sockets.
• Only the supplied AC power lead should be connected to the nerve monitor. If
required, replacement/s can be obtained via the sales department.
• The nerve monitor must not be used in the vicinity of objects sensitive to magnetic
fields.
• Neurosign®stimulating probes have been specifically designed to limit the current
density at the tips. Do not use non-Neurosign®devices as these may not comply
with the current density limits.
• Wireless/Bluetooth export is not intended to be used when monitoring mode is
active
• It is the responsibility of the user to identify, analyse, evaluate and control potential
risks every time a device is connected or disconnected.
• DO NOT step on the device.
• DO NOT sit on the device.
• The maximum load permitted on the device is 1.5kg and should not be exceeded.