User's Manual

SE-1010 PC ECG User Manual Cleaning, Care and Maintenance
- 150 -
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 500 µA, SFC
1000 µA
g) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100 µA, SFC
500 µA.
h) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10 µA, d.c.
10 µA; SFC a.c. 50 µA, d.c. 50 µA.
i) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10 µA, d.c.
10 µA; SFC a.c. 50 µA, d.c. 50 µA.
j) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50 µA (CF).
The data should be recorded in an equipment log. If the equipment is not functioning properly or
fails any of the above tests, the equipment has to be repaired.
WARNING
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failures and possible health hazards.