EDAN SE-3 Series User Manual page 76

SE-3&SE-300 Series Electrocardiograph User Manual
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.
Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c.
i)
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).
k) Test the essential 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. 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.
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failures and possible health hazards.
1) Main Unit
♦
Avoid excessive temperature, sunshine, humidity or dirt.
♦
Put the dustproof coat on the main unit after use and prevent shaking it violently when
moving it to another place.
♦
Prevent any liquid from seeping into the equipment, otherwise the safety and
performance of the electrocardiograph can not be guaranteed.
2) Patient Cable
♦
Integrity of the patient cable, including the main cable and lead wires, should be
checked regularly. Make sure that it is conductible.
♦
Do not drag or twist the patient cable with excessive stress while using it. Hold the
connector plug instead of the cable when connecting or disconnecting the patient cable.
♦
Align the patient cable to avoid twisting, knotting or crooking in a closed angle while
using it.
♦
Store the lead wires in a big wheel to prevent any people from stumbling.
♦
Once damage or aging of the patient cable is found, replace it with a new one
immediately.
WARNING
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Cleaning, Care and Maintenance