Sentec LuMon, Service Manual, Page: 14 / 33

Maintenance/Safety and Functionality Tests
14 of 33 Service Manual for the LuMon™ System
3.2.4 Electrical Safety Check
The LuMon™ System has been designed to comply with the IEC 60601-1 standard:
•
Safety approvals and applied part BF: IEC 60601-1 (3 rd edition)
•
Electromagnetic compatibility (EMC): IEC 60601-1-2 (4 rd edition)
To ensure electrical safety of the equipment it is recommended that qualified service personnel performs the
electrical safety check once a year (but every two years the latest) and after repair.
The electrical safety check for the LuMon™ System must be performed in accordance with the IEC
62353:2014 standards for medical electrical equipment classified as Class 1 and Applied Part Type BF.
Technicians must be familiar with these standards applicable to the institution and the country. Test equipment
and its application must comply with the applicable standard.
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Safety test according to IEC 62353 may be performed if the following criteria are met:
•
The LuMon™ Monitor has not been opened.
•
No changes have been made to the mains power connections and none of the protective earth
connections (PE) have been disconnected.
Tools : Electrical safety analyzer for tests according to IEC 62353 (e.g. Rigel 288, Fluke ESA615 or Gossen
Metrawatt Secutest)
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If the required equipment is not available, send the LuMon™ Monitor to a
SenTec Authorized LuMon™
Technician,
your local SenTec representative or SenTec AG for testing.
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If equipment is send to a
SenTec Authorized LuMon™ Technician,
your local SenTec representative or SenTec
AG please refer to section ‘instructions for repackaging and shipping’ of the User’s Guide for the LuMon™
System [1].
A complete ‘Certificate of Disinfection’ [6] and, if applicable, the ‘Repair or Investigation Request Form’ [7] must
be provided.
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Prior to maintenance, service or repair, all components of the LuMon™ System must be cleaned and
disinfected. More details can be found in section ‘cleaning and disinfection’ of the User’s Guide for the LuMon™
System [1].
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Before performing the safety test, read the operating instructions of your safety analyzer.
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Make sure that all connecting cables are plugged in correctly. Poor or missing connections may lead to false
positive test results.
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If safety or functionality test fails, the respective problem must be fixed before the equipment is returned to the
user.
The belt and the belt connector are an applied part of Type BF. The interface ports of the LuMon™ Monitor are
isolated with 2 MOPP to the belt connector socket and 1 MOPP to the mains input. There is no isolation
between the individual interface ports.
The electrical safety check is performed according to IEC 62353. The following connections must be tested:
•
Protective Earth Resistance Test: Earth wire of the AC power cord, Equipotentiality terminal
connector (ground). The resistance between two of these must be less than 0.3
Ω
.
•
Earth Leakage Current: The current must be
below 5’000 µ A (normal condition
) /
10’000 µ A
(single fault condition ) see IEC 60601-1 Figure 13 and chapter 8.7.3 d).
•
Patient Leakage Current from patient connection to earth. The current must be below 100
µ
A
(normal condition) / 500 µ A (single fault condition)
see IEC 60601-1 Figure 15.