Warnings & Precautions - MAGSTIM NEUROSIGN V4 User Manual

3.1 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
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 "6.3 User Maintenance & Calibration" on page 76, no
user-serviceable parts are found within the Neurosign
Monitor. Please refer to page 75 for proper Care and Maintenance information.
• Opening the case presents a serious threat of electric shock and immediate risk
to the user.
The Magstim Company Ltd.
V4 Intraoperative Nerve Monitor is designed for use during surgical
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V4 Intraoperative Nerve
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