Shenzhen Comen Medical Instruments co., ltd.
5
♦ Be sure that there is no intense electromagnetic interference source
around the equipment, such as radio transmitter or mobile phone etc.
Attention: large medical electrical equipment such as electrosurgical
equipment, radiological equipment and magnetic resonance imaging
equipment etc. are likely to bring electromagnetic interference.
CAUTION :
♦ Before use, the equipment, patient cable and electrodes etc. should be
checked. Replacement should be taken if there is any evident
defectiveness or aging symptom which may impair the safety or
performance.
♦ The following safety checks should be performed at least every 24
months by a qualified person who has adequate training, knowledge,
and practical experience to perform these tests.
a) Inspect the equipment and accessories for mechanical and
functional damage.
b) Inspect the safety relevant labels for legibility.
c) Inspect the fuse to verify compliance with rated current and
breaking characteristics.
d) Verify the device functions properly as described in the
instructions for use.
e) Test the protection earth resistance according IEC 601-1/1988:
Limit 0.2 ohm.
f) Test the earth leakage current according IEC 601-1/1988: Limit:
NC 500 uA, SFC 1000uA.
g) Test the patient leakage current according IEC 601-1/1988: Limit:
10 uA (CF).
h) Test the patient leakage current under single fault condition with
mains voltage on the applied part according IEC 601-1/1988:
Limit: 50uA (CF).
The data should be recorded in an equipment log. If the device is not
functioning properly or fails any of the above tests, the device has to be
repaired.
♦ Ruptured fused must only be replaced with the same type and rating as
the original.
♦ The equipment and reusable accessories can be sent back to the
manufacturer for recycling or proper disposal after their useful lives.
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