DATREND Systems ES601-US, Operating Manual

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ES601-US OPERATING MANUAL
Overview/Chapter 2
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Page 13
The way in which lead leakage must be measured is highly dependent on the standard and on the specified
group "Type". For AAMI-ES1 standard, collective leakage is measured for patient source current, but then
is measured individually from each lead for patient sink current (isolation test of Group 1, Type BF/CF). If
the safety standard is IEC60601, and a patient lead group is designated "Type CF", then the leakage current
produced by each patient connection within that group is measured individually. For a patient lead group
which is "Type B" or "Type BF", then the collective leakage of the group is measured. In accordance with
the Third Edition of IEC60601, if testing Mains on Applied Parts (MAP) of a specific group of patient
connections, then any other patient lead groups provided by the DUT that are not being MAP-tested must
be connected to ground. If testing "Type CF" defibrillator paddles in accordance with the IEC60601-2-4
standard, then collective leakage of the paddles is measured, but only when performing the MAP test. For
this special case, a higher leakage is permitted than is otherwise allowed under the general standard. For
VDE-0751 and IEC62353 standards, patient connections are also tested in functional groups, however,
collective leakage of each group is always measured regardless of the group "Type".
The complicated details of testing patient lead leakage are managed automatically by ES601-US, simply by
making a choice of safety standard and selecting an appropriate "Type" for each different group of patient
connections provided by the DUT (ECG; invasive blood pressure; temperature; SpO2; and so on). Setting
up ES601-US to perform patient leakage measurements is relatively simple and is further explained in
section 5.10.
When testing patient leakage, ES601-US can be configured to record the following AC and DC values for
each group of parts defined in the test setup:
Normal Polarity Normal Condition
Single-Fault Condition, Neutral Open
Single-Fault Condition, Ground Open
Single-Fault Condition, Isolation Test
(1)
(NP:NORM.)
(NP:OPEN N.)
(NP:OPEN G.)
(NP:ISO. TST.)
Reverse Polarity Normal Condition
Single-Fault Condition, Neutral Open
Single-Fault Condition, Ground Open
Single-Fault Condition, Isolation Test
(1)
(RP:NORM.)
(RP:OPEN N.)
(RP:OPEN G.)
(RP:ISO. TST.)
(1) Type BF or CF patient leads only; not tested for Type B
Under the IEC60601 standard, patient connections within "Type CF" groups are tested individually in turn.
In this case, for each normal (NC) and single-fault (SF) condition ES601-US will record the number of the
patient connection that produces the highest leakage.
In addition to NC and SF conditions listed above, IEC60601 and AAMI-ES1 standards require
supplementary test conditions (STC). ES601-US allows the user to optionally enable or disable the STC in
the leakage setup, according to the characteristics of the DUT. Optional STC include: