SE-3 Electrocardiograph Service Manual Safety Guidance
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CAUTION
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 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 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).
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.
6. Ruptured fuses must only be replaced with those of the same type and rating as the
original.
7. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do not dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or the battery, please contact your
local Civic Office, or the shop where you purchased the product.
8. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
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