Maintenance Of Main Unit, Patient Cable And Electrodes - EDAN SE-601 Series User Manual

to illegible ECG reports and block the advance of the paper.
Storage Requirements:
♦ Recorder paper should be stored in a dry, dark and cool area, avoiding excessive
temperature, humidity and sunshine.
♦ Do not put the recorder paper under fluorescence for a long time.
♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage
environment, which will lead to color change of the paper.
♦ Do not overlap the recorder paper for a long time, or else the ECG reports may
trans-print each other.

13.3.3 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 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).
The leakage current should never exceed the limit. 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.
WARNING
institution employing the use of this equipment to implement a satisfactory
maintenance schedule may cause undue equipment failures and possible health
hazards.
SE-601 Series Electrocardiograph User Manual
: Failures on the part of the responsible individual hospital or
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