Hardware Instructions for Use
12
Excerpt from the IEC 60601-1 Standard
CAUTION
When connecting other equipment, qualified attention must be paid to the
following excerpt from the medical safety standard to which this system complies.
IEC 60601-1 Medical Electrical Equipment, Part 1:
General Requirements for Basic Safety and Essential Performance.
Chapter 16: Medical Electrical Systems.
When connecting to a medical appliance with an F-type applied part, or some additional
equipment complying not with IEC 60601-1 but with the relevant safety standard for such
equipment, the additional equipment:
1)
must either be placed outside the patient environment --the patient environment is any
area in which intentional, or unintentional contact can occur between patient and parts of
the system (e.g. a printer, VEP Monitor) or as a result of some other person touching parts
of the system;
or
2) if placed within the patient environment, must be:
a) provided with an additional protective earth connector;
or
b) supplied from a separating transformer, limiting the enclosure/touch leakage current to
a value not exceeding:
N
ormal
C
ondition: 0.1 mA or
S
ingle
F
ault
C
ondition 0.5 mA.
Please refer to IEC 60601-1 for further details.
