Handheld monitor user’s manual
Chapter 9-3
The data should be recorded in an equipment log. If the
device is not functioning properly or fails any of the
following tests, the device has to be repaired.
① Inspect the equipment and accessories for mechanical and
functional damage.
②
Inspect the safety relevant labels for legibility.
③
Verify that the device functions properly as described in
the instructions for use.
④ Test the earth leakage current according IEC
60601-1:1988 + A1:1991 + A2:1995: Limit: NC 500μA,
SFC: 1000μA.
⑤
Test the enclosure leakage current according to IEC
60601-1:1988 + A1:1991 + A2:1995: Limit: NC 100μA,
SFC: 500μA.
⑥ Test the patient leakage current (normal operation)
according IEC 60601-1:1988 + A1:1991 + A2:1995:
Limit: type CF: for a.c.: 10μA, for d.c.: 10μA.
⑦ Test the patient leakage current under single fault
condition according IEC 60601-1:1988 + A1:1991 +
A2:1995:
Limit: type CF: for a.c.: 50μA, for d.c.: 50μA.
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