MAGSTIM NEUROSIGN V4 User manual

THE NEUROSIGN®V4
INTRAOPERATIVE NERVE MONITOR
PRESERVING NERVE INTEGRITY
User Manual
NOP08-EN-10
March 2021
2797

The Magstim Company Ltd.©ii
NOP08-EN-10
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 is accurate at time of publication.
Company details
Neurosign®
The Magstim Company Limited
Spring Gardens, Whitland,
Carmarthenshire, SA34 0HR
Website: https://www.neurosign.com
Product Enquiries
Telephone: [phone]
E-mail: [e-mail]
Servicing Enquiries
Telephone: [phone]
E-mail: [e-mail]
Sales Enquiries
Telephone: [phone]
E-mail: [e-mail]
YOUR LOCAL REPRESENTATIVE
Authorised Representative in the European Union:
Technomed Europe
Amerikalaan 71, 6199 AE Maastricht-Airport,
The Netherlands
Tel: [phone]

The Magstim Company Ltd.©iii
NOP08-EN-10
Welcome to the
Neurosign®V4 Intraoperative Nerve Monitor

The Magstim Company Ltd.©iv
NOP08-EN-10
Page intentionally left blank.

The Magstim Company Ltd.©v
NOP08-EN-10
The Neurosign®V4 Intraoperative Nerve Monitor (referred to as 'nerve monitor') is a
Neurosign®product and belongs to the Neurosign®division of The Magstim Company
Limited.
This user manual has been written to 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 important to ensure that the most up-to-date documents are used as reference
materials. Documents are available from Neurosignsurgical.com or on request from
your local Neurosign®representative. See page ii for contact details.
Preface

The Magstim Company Ltd.©vi
NOP08-EN-10
Page intentionally left blank.

The Magstim Company Ltd.©vii
NOP08-EN-10
Company details ii
Preface v
Devices Covered 9
Product Guarantee 11
PRODUCT OVERVIEW 13
1.1 Product Description 14
1.2 Indications & Contraindications 15
1.3 Front View 16
1.4 Rear View 17
ACCESSORIES 19
2.1 Pre-Amplifier 20
2.2 Stimulator Pod 21
2.3 Mute Sensor 21
2.4 Disposables 22
2.5 Connections 24
WARNINGS & SYMBOLS 25
3.1 Warnings & Precautions 26
3.2 Device symbols key 29
3.3 Touch screen symbols Key 31
INSTRUCTIONS FOR USE 35
4.1 System Configuration 36
4.2 Connection & Disconnection 38
4.3 Adjusting The Screen Tilt 41
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 61
TROUBLE SHOOTING 65
5.1 Alarm Overview 66
5.2 Non-Recoverable Error 67
5.3 System Alarms & Messages 67
5.4 Troubleshooting (Physical) 71
5.5 Neurosign V4 Earthing Cable 73
CARE & MAINTENANCE 75
6.1 Cleaning & Disinfecting 76
6.2 Storage & Environment 76
6.3 User Maintenance & Calibration 76
6.4 Servicing & Device Lifetime 77
6.5 Packaging & Transportation 78
6.6 Decommissioning 78
TECHNICAL INFORMATION 79
7.1 Safety Specification 80
7.2 Technical Specification 80
7.3 General Specification 82
7.4. System Details 83
7.5 Glossary Of Terms 84
7.6 Document Version/s 85
Contents

The Magstim Company Ltd.©viii
NOP08-EN-10
Page intentionally left blank.

The Magstim Company Ltd.©9
NOP08-EN-10
This user 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: Disposables that are compatible are listed in "2.4 Disposables" on page
22. Full documentation regarding disposables is provided along with the item/s.
Alternatively documentation can be obtained on request from your Neurosign®
representative.
Devices Covered

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

The Magstim Company Ltd.©11
NOP08-EN-10
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 Ltd. 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 "6.4 Servicing & Device Lifetime" on page 77 for more
information.
Product Guarantee

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

The Magstim Company Ltd.©13
NOP08-EN-10
SECTION 1
PRODUCT OVERVIEW

The Magstim Company Ltd.©14
NOP08-EN-10
TheNeurosign®V4IntraoperativeNerveMonitoris a multi-channeltouchscreennerve
monitor designed for use in ENT surgery and neurosurgery.
Using Neurosign®needle or surface electrodes connected to the pre-amplifier, the
nerve monitor detects EMG signal within muscles caused by the contraction of the
muscle due to mechanical or electrical stimulation of the nerve controlling it. The
nerve monitor then amplifies the EMG data into an audible signal and displays the
data as a waveform on the active monitoring screen (page 43).
The nerve 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 the touch screen, except for the three
dedicated control dials located below the screen for the Master Volume, Stimulator 1
and Stimulator 2 adjustments.
A connection for up to two stimulating probes is provided via the stimulator pod so
that suspect tissue or a nerve, may be directly stimulated during the surgery using a
Neurosign®stimulating probe.
The nerve monitor has a number of self-checking routines to ensure that the unit is
working reliably. In the event of failure the unit will alert the operating room staff and
prevent further use.
1.1 Product Description

The Magstim Company Ltd.©15
NOP08-EN-10
a. Intended Use
The Neurosign®V4 Intraoperative Nerve Monitor is intended for locating and
identifying cranial and peripheral motor and mixed motor-sensory nerves during
surgery, including spinal nerve roots.
b. Indications For Use
Indications for 4 channel intraoperative nerve monitoring include, Intracranial
surgeries, Extracranial surgeries (e.g. parotidectomy), Intratemporal surgeries (e.g.
mastoidectomy), Extratemporal surgeries, Neck surgeries (e.g. thyroidectomy).
Indications for 8 channel intraoperative nerve monitoring include, Intracranial
surgeries, Extracranial surgeries (e.g. parotidectomy), Intratemporal surgeries (e.g.
mastoidectomy), Extratemporal surgeries, Neck surgeries (e.g. thyroidectomy), Spinal
surgeries (e.g. tethered cord, degenerative treatments, pedicle screw procedures,
cauda equina, fusion cages, rhizotomy, and open/percutaneous lumbar procedures),
Surgeries to 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 significantly reduce, if not completely eliminate, EMG responses to electrical
or mechanical nerve stimulation.
The nerve monitor requires the patient to have a relevant pre-operative functioning
nerve in order to detect the relevant EMG responses.
d. Training
The nerve monitor is intended to be used with the minimum of training. However it is
assumed that those interacting with the unit are qualified to the minimum standard
to be present in the operating theatre during surgery and are overseen by a qualified
surgeon.
The nerve monitor should only be used by those who have fully read and understood
this user manual, in conjunction with training provided by a certified Neurosign®
trainertoensureproperunderstandingoftheproduct, disposables and the associated
protocols.
Please contact The Magstim Company Ltd. to arrange training. Contact details can be
found on page ii.
1.2 Indications & Contraindications

The Magstim Company Ltd.©16
NOP08-EN-10
1.3 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 See page 24 for more
information.
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.

The Magstim Company Ltd.©17
NOP08-EN-10
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.
1.4 Rear View
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
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 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
See "4.3 Adjusting The Screen Tilt" on
page 41 for information.
18. Equipotential Point
See "a. Electrical Testing" on page 77
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.

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

The Magstim Company Ltd.©19
NOP08-EN-10
SECTION 2
ACCESSORIES

The Magstim Company Ltd.©20
NOP08-EN-10
2.1 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.
Plug the stimulator pod
connection lead into here (see
page 21).
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 17).
26. Pre-Amplifier
Connection Lead
25. Stimulator Pod Socket
22. Electrode
Channels 1 - 4
24. Electrode
Channels 5 - 8
23. Reference
Electrode
Channel
21. Mounting
Clip