Excerpt From The Iec 60601-1 Standard - natus Dantec Keypoint G4 Hardware Instructions For Use

Dantec Keypoint G4

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), 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 an extra separating transformer, limiting the enclosure/touch leakage
current to a value not exceeding: Normal Condition: 0.1 mA or Single Fault Condition
0.5 mA.
Please refer to IEC 60601-1 for further details.
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