Maintenance Of Main Unit, Patient Cable & Electrodes - KONTROLab EC-300 Manual De Usuario

8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes
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 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 0.2ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500uA, SFC
1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10uA (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 leakage current should never exceed the limit. 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.
WARNING
1) Main Unit
♦
Avoid excessive temperature, sunshine, humidity and dirt.
♦
Put on the dustproof coat after use and prevent from shaking violently when moving it
to another place.
♦
Prevent any liquid from seeping into the equipment, for it will affect the safety and
performance of the electrocardiograph.
2) Patient Cable
♦
Integrity of patient cable, including main cable and lead wires, should be checked
regularly. And be sure that it is conductible.
♦
Do not drag or twist the patient cable with excessive stress while using. Hold the
connector plugs instead of the cable when connecting or disconnecting the patient
: Failure on the part of the responsible individual hospital or
institution employing the use of this equipment to implement a
satisfactory maintenance schedule may cause undue equipment
failure and possible health hazards.
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