SE-3 3-Channel Electrocardiograph User Manual
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perform these tests.
a) Inspect the equipment and accessories for mechanical and functional
damage.
b) Inspect the safety relevant 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
0.2 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC
500 uA, SFC 1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10
uA (CF).
h) Test the patient leakage current under single fault condition with mains
voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA
(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 fuse must only be replaced with the same type and rating as the
original.
7. When the effective lifetime of the equipment and accessories is over, collect and
classify them, and dispose them according to local regulations.
8. Federal (US) law restricts this device to sale by or on the order of a physician.
1.2.4 Cleaning & Disinfection Cautions
CAUTION
:
9. Turn off the power before cleaning and disinfection. If mains supply used, the
power cord should be drugged out of the outlet also. And prevent the detergent
from seeping into the equipment.
10. Do not immerse the unit or patient cable into liquid under any circumstances.
11. Do not clean the unit and accessories with abrasive fabric and avoid scratching
the electrodes.
12. Any remainder of detergent should be removed from the unit and patient cable
after cleaning.
13. Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.