EDAN iSE-301 User Manual - page 52
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance
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Do not overlap the recorded paper for a long time, or else the ECG reports may
trans-print each other.
9.4.3
Maintenance of the Main Unit, the 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 rated current and breaking characteristics.
d) Verify the device functions properly as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, 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.
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
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.