EDAN SE-1515 User Manual - page 95
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance
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2. Wipe off the disinfectant solution with a dry cloth after disinfection.
3. Leave the suction bulbs and clamps to air dry for at least 30 minutes.
10.4 Maintenance of ECG Sampling Box
CAUTION
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) Verify that the device functions properly as described in the instructions for use.
d) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
e) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, SFC
1000 μA
f) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100 μA,
SFC 500 μA.
g) 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.
h) 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.
i) 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).
j) Test the essential performance according to IEC/EN 60601-2-25, or methods
recommended by the hospital or local distributor.
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.