SE-1 Electrocardiograph User Manual Safety Guidance
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1.2.3 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. 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 the performance.
5. 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 the rated current and circuit-breaking
characteristics.
d) Verify that the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.1 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500μA, SFC
1000μA.
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA,
SFC 500μA.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA,
d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA,
d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
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