User's Manual

SE-1200 Pro&SE-1201 Pro Electrocardiograph User Manual Cleaning, Care and Maintenance
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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 as described in the instructions for use.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1
ohms.
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 actual 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 correctly or fails any of the above tests,
the equipment has to be repaired.
WARNING
1. Failure from 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 severe incident concerning the device should be reported to the manufacturer
and the Member State's competent authority in which the user and patient are
established.
Main unit
 Avoid excessive temperature, sunshine, humidity, and dirt.