4
♦ When the battery’s useful life is over, contact with the manufacturer or local distributor
for disposal or dispose the battery according to local regulations.
1.2.3 General Cautions
CAUTION :
♦ Avoid liquid splash and excessive temperature. The temperature must be kept between
5℃ and 40℃ while working. And it should be kept between -20℃ and 55 ℃ during
transportation and storage.
♦ Do not use the equipment in dusty environment with bad ventilation or in the presence
of corrosive.
♦ 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).
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