EDAN iSe Series User Manual page 73

iSE Series Electrocardiograph User Manual
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 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).
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. Checks 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.
1. 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.
2. Any serious incident that has occurred in relation to the device should be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.
Main unit and sampling box
Avoid excessive temperature, sunshine, humidity and dirt.
Put the dustproof coat on the main unit and sampling box after use and prevent
Cleaning, Care and Maintenance
WARNING
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