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6.1 Safety Specification
The Neurosign
®
safety standard IEC 60601-1.
a. Classification, protection against electrical shock
With reference to safety standard IEC 60601-1 the nerve monitor and its accessories
are classified as:
CLASS I
Equipment must only be connected to supply mains with protective earth.
Connection should only be made with the power lead provided with the
equipment
Type BF
Applied Parts : stimulating probes, stimulator pod, electrodes and pre-amplifier
circuits are electrically isolated from the other parts of the equipment and meet
Type BF leakage current limits.
Continuous Mode Of Operation
b. EMC
The nerve monitor and its accessories comply with the requirements of EMC Standard
EN 60601-1-2. Refer to the user manual for more information.
Note: To avoid problems with EMC interference, the nerve monitor should not be
used in the vicinity of any equipment that does not comply with EMC Safety Standard
EN 60601-1-2, including mobile phones. Any interface cable which connects the
nerve monitor to an external piece of equipment not supplied by the The Magstim
Company Ltd. must be no more than 4m in length.
c. Connection of 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.
d. Degree of protection provided by enclosure
The nerve monitor and its accessories are classified as IPX0 (Not Protected), as
specialised protection provided against the ingress of liquids is not required.
e. Flammable and combustive environments
The Neurosign
V4 Intraoperative Nerve Monitor and its accessories are not protected
®
from, and should not be used in, the following environments (safety standard IEC
60601-1):
•
Flammable anaesthetic mixtures with air, oxygen or nitrous oxide.
•
Oxygen rich environments
The Magstim Company Ltd.©
V4 Intraoperative Nerve Monitor and its accessories comply with
NOP20-EN-03
44
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