DATREND Systems ES601 Plus - Patient Auxiliary Leakage Current; Alternative and Direct Methods of Leakage Current Measurement

ES601Plus OPERATING MANUAL
2.1.9 Patient Auxiliary Leakage Current
In this test, sometimes called an interlead leakage test, ES601Plus measures the current that flows out of
one applied part, through the human body load, and into all the other applied parts shorted together. As
with all leakage tests, auxiliary leakage current is measured in microamps, while simulating a variety of test
conditions at the DUT.
In addition to specifying the individual test cases, the auxiliary leakage measurement requires the kind of
applied parts tested to be classified as "B” - body, "BF” - body-floating or "CF” - cardiac-floating. This is
done through the Group setup as described in the preceding section. Up to ten applied parts can be
arbitrarily partitioned into the five Groups provided by the test setup.
When testing auxiliary leakage, ES601Plus can be configured to record the following AC and DC values for
each applied part defined in the test setup:
Normal Polarity Normal Condition
Single-Fault Condition, Line 2 Open
Single-Fault Condition, Earth Open
(NP:NC)
(NP:SF L2O)
(NP:SF EO)
Reverse Polarity Normal Condition
Single-Fault Condition, Line 2 Open
Single-Fault Condition, Earth Open
(RP:NC)
(RP:SF L2O)
(RP:SF EO)
In addition to these six test conditions, IEC60601 and AAMI-ES1 standards require a supplementary test
condition (STC) where the power switch on the DUT can be set to either "ON" or "OFF". If this STC is
enabled, ES601Plus measures auxiliary leakage for each normal (NC) or single-fault (SF) condition in
combination with the DUT power switch in "ON" or "OFF" position. For each NC or SF test condition,
ES601Plus records the maximum leakage observed and the STC ("ON" or "OFF") that produced the
maximum leakage.
2.1.10 Alternative and Direct Methods of Leakage Current Measurement
These methods for measurement of Device Leakage and Patient Leakage are set out in VDE-0751, which is
the electrical safety standard for medical devices developed by Verband der Elektrotechnik, Elektronik und
Informationstechnik (VDE), the organization that sets standards for all electrical equipment marketed in
Germany. VDE-0751 test procedures are simplified forms of IEC60601 test methods, and are specifically
intended for post-repair testing of serviced electromedical equipment. Acceptance limits are comparable to
IEC60601 but are tailored to suit the simplified nature of the test protocols.
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