Maintenance Of Main Unit, Patient Cable And Electrodes - EDAN SE-1 User Manual

SE-1 Electrocardiograph User Manual
trans-print each other.
Note: Recorder paper provided by the manufacturer should be used. Other paper may
shorten the life of the thermal print head. The deteriorated print head may lead
to illegible ECG reports and block the advance of the paper.

11.4.3 Maintenance of Main Unit, Patient Cable and Electrodes

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 related 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.
j) Test the patient leakage current under single fault condition with mains voltage on
the applied part according to IEC/EN 60601-1: Limit: 50μA (CF).
k) Test the essential performance according to IEC/EN 60601-2-25, or methods
recommended by the hospital or local distributor.
Cleaning, Care and Maintenance
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