Handheld pulse oximeter user’s manual
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 must be repaired.
①
Inspect the equipment and accessories for mechanical
and functional damage.
②
Inspect the relevant safety labels for legibility.
③
Verify that the device functions properly, as described in
the instructions for use.
④
Test the earth leakage current, according to IEC 60601-
1:1988 + A1:1991 + A2:1995: Limit: NC 500
μ
A, SFC:
1000
μ
A.
⑤
Test the enclosure leakage current according to IEC
60601-1:1988 + A1:1991 + A2:1995: Limit: NC 100
μ
A,
SFC: 500
μ
A.
⑥
Test the patient leakage current (normal operation)
according IEC 60601-1:1988 + A1:1991 + A2:1995:
Limit: type BF: for a.c.: 100
μ
A, for d.c.: 100
μ
A.
⑦
Test the patient leakage current under single fault
condition according to IEC 60601-1:1988 + A1:1991 +
A2:1995:
Limit: type BF: for a.c.: 5mA, for d.c.: 5mA.
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