Performance Verification Procedures 5: Performance Verification
173
IEC62353
Some countries require service personnel to follow IEC62353 when examining the device before returing
it back to the user, after Maintenance, Inspection, or Repair. Service personnel must assess the safety of
Medical Electrical Equipment And Medial Electrical System and comply with IEC60601-1.
This section describes the tests of Efficia DFM100’s electrical safety based on the requirement of
IEC62353. For those facilities which follow IEC62353, follow the instructions listed in this section.
This section is organized into the following topics:
Te st Met h o d . . . . . . . . . . . . . . . . . . p. 173
Protective Earth Resistance . . . . . . . . . . . . . . . p. 173
Insulation Resistance (Not Mandatory) . . . . . . . . . . . . . p. 174
Leakage Currents . . . . . . . . . . . . . . . . . p. 176
Chassis (Enclosure) Leakage . . . . . . . . . . . . . . . p. 176
Patient Lead Leakage . . . . . . . . . . . . . . . . p. 176
Test Method
In order to establish a systematic maintenance plan, Philips recommends all safety tests and records be
made under the following circumstances:
• Upon reception of the Efficia DFM100,
• Every year, and
• Whenever the Efficia DFM100 is opened for repair.
The steps used for these tests and the acceptable ranges of values are derived from local and international
standards but may not be equivalent. These tests are not a substitute for local safety testing where it is
required for an installation or a service event.
Protective Earth Resistance
Figure 134 illustrates the protective earth resistance measurement of Efficia DFM100.
Figure 134 Efficia DFM100 Protective Earth Resistance Test Diagram
Acceptable test results (Maximum impedance):
With detachable power supply cord, x <
200m(IEC 62353).
Detachable power supply cord, x <
100m(IEC 62353).
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