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SE-1201 Electrocardiograph User Manual
13.3.4 Maintenance of the Main Unit and the Patient Cable
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
The following safety checks should be performed at least every 12 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).
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.
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.
CAUTION
WARNING
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Cleaning, Care and Maintenance
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