SE-2003&SE-2012 Series Holter System Recorder User Manual
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7.4.2 Maintenance of the Recorder and the Patient Cable
CAUTION
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
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.
a) Inspect the recorder and accessories for mechanical and functional damage.
b) Inspect the safety related labels for legibility.
c) Verify that the recorder functions properly as described in the instructions for use.
d) 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.
e) 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.
f) 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).
g) Test the essential performance according to IEC 60601-2-47, 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 recorder is not functioning properly or fails any of the above tests, the recorder has to
be repaired.
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.
1) Recorder
♦ Avoid excessive temperature, sunshine, humidity and dirt.
♦ Put the dustproof coat on the recorder after use and prevent shaking it violently when
moving it to another place.
♦ Prevent any liquid from seeping into the recorder; otherwise the safety and the
performance of the recorder can not be guaranteed.
2) Patient Cable
♦ Integrity of the patient cable, including the main cable and lead wires, should be checked
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