Instrument Safety Test; System Test; What Is A Medical Electrical System; General Requirements For A System - Philips Avalon CTS M2720A Service Manual

6 Preventive Maintenance and Safety
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Instrument Safety Test

You must perform the instrument safety test every time you exchange, repair, upgrade or in any other way
work on the power supply or the power inlet. You must test the system as a stand-alone system, and as a
system in conjunction with the fetal monitor.
The instrument safety test is made up of four separate tests :
Protective Earth Test
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Enclosure Leakage Current - Normal Condition
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Enclosure Leakage Current - Single Fault Condition
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Patient Leakage Current - Single Fault Condition
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System Test

After mounting and setting up a system, perform system safety tests.

What is a Medical Electrical System?

A medical electrical system is a combination of at least one medical electrical device and other electrical
equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

General Requirements for a System

After installation or subsequent modification, a system must comply with the requirements of the system
standard IEC/EN 60601-1-1. Compliance is checked by inspection, testing or analysis, as specified in the
IEC 60601-1-1 or in this book.
Medical electrical equipment must comply with the requirements of the general standard IEC/EN 60601-
1, its relevant particular standards and specific national deviations. Non-medical electrical equipment shall
comply with IEC and ISO safety standards that are relevant to that equipment.
Relevant standards for some non-medical electrical equipment may have limits for enclosure leakage
currents higher than required by the standard IEC 60601-1-1. These higher limits are acceptable only
outside the patient environment. It is essential to reduce enclosure leakage currents when non-medical
electrical equipment is to be used within the patient environment.
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