Bladder Volume Tester User’s Manual V1.02
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Test the protection earth resistance according to IEC 60601-1: Limit: 0.1Ω.
Test the earth leakage current according to IEC 60601-1: Limit: Normal Condition 500µA, Single
Fault Condition: 1000µA.
Test the touch current according to IEC 60601-1: Limit: Normal Condition 100µA, Single Fault
Condition: 500µA.
Test the patient leakage current according to IEC 60601-1: Limit: for a.c.: 100µA for d.c.: 10µA
Test the patient leakage current under single fault condition with mains voltage on the applied part
according to IEC 60601-1: Limit: for a.c.: 500µA for d.c.: 50µA.
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.
2. Please clean the plug of power cord at least once a year. Too much dust on plug may cause the fire.
12.9 Essential Performance Checks
In the cause of using the instrument, due to electromagnetic disturbance making the instrument
generate artifacts or distortion in an image or error of a displayed numerical value; or making the
instrument generate the display of incorrect numerical values associated with the diagnosis to be
performed; or making the instrument generate the production of unintended or excessive ultrasound output;
or making the instrument generate the production of unintended or excessive transducer assembly surface,
should go to a qualified testing organization for IEC 60601-1-2 test.
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