Cleaning & Disinfection Cautions - EDAN SE-601 Series User Manual

5. The following safety checks should be performed at least every 24 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 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 fuse must only be replaced with that of the same type and rating as
the original.
7. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.2.4 Cleaning & Disinfection Cautions
CAUTION
1. Turn off the power before cleaning and disinfection. If the mains supply is used,
the power cord should be dragged out of the outlet. Prevent the detergent from
seeping into the equipment.
2. Do not immerse the unit or the patient cable into liquid under any
circumstances.
3. Do not clean the unit and accessories with abrasive fabric and avoid scratching
the electrodes.
4. Any remainder of detergent should be removed from the unit and the patient
cable after cleaning.
5. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
SE-601 Series Electrocardiograph User Manual
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