EDAN U60 - Maintenance

U60 Diagnostic Ultrasound System User Manual Inspection and Maintenance
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15.4. Maintenance
CAUTION
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
WARNING
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.
Maintenance must be performed every 12 months, including the safety and functionality of the
system.
The following safety checks should be performed at least every 12 months by a qualified person
who has adequate training, knowledge, and practical experience to perform these tests.
 Inspect the safety-related labels for legibility.
 Inspect the fuse to verify compliance with rated current and breaking characteristics.
 Verify that the device function properly as described in the instructions for use.
 Test the protection earth resistance according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: 0 - 0.1 Ω.
 Test the earth leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37: Limit:
NC 500 μA, SFC 1000 μA.
 Test the patient leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: AC NC 100 μA, SFC 500 μA, DC NC 10 μA, SFC 50 μA.
 Test the enclosure leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: NC100 μA, SFC 500 μA.
 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 any
of the above tests fail, please contact the maintenance personnel of EDAN.