DATREND Systems ES601 Plus, Operating Manual

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ES601 Plus OPERATING MANUAL
APPLIED PARTS: If set to "TEST", measurement of patient leakage is enabled. If set to
"DO NOT TEST", patient leakage is disabled. All safety standards
require applied parts to be tested if the DUT provides applied parts
(e.g.: ECG leads; blood pressure transducer; temperature probe; SpO2
probe; etc).
AUXILIARY
LEAKAGE:
If set to "TEST", measurement of auxiliary (lead-to-lead) leakage is
enabled. If set to "DO NOT TEST", auxiliary leakage is disabled.
To enable auxiliary leakage measurements, APPLIED PARTS must be
set to "TEST".
For full compliance with requirements of IEC60601 and AAMI-ES1
standards, this control should be set to "TEST". However, this setting
will cause each patient connection to be individually tested. This will
increase the length of time required to complete the leakage test, and
will substantially increase the amount of information which will be
included in the reported test results. The extent of such increases in
test time and reported data will depend on the number of leads that
must be tested.
ISOLATED
SIGNAL I/O: Options are "DO NOT TEST" (default) or "TEST!" This parameter
determines whether an isolated voltage equal to 110% of the AC
supply will be output from the AUX1 jack of ES601
Plus
. The AUX1
output is current-limited to a few milliamperes.
AUX1 is intended to connect to isolated input or output signals
provided by the DUT. An example of an isolated signal input/output
would be a Ethernet data connection which achieves isolation by
means of a signal transformer internal to the DUT.
This test is mandatory under IEC60601 and AAMI-ES1 standards
when the DUT has an
is o late d data connection such as an Ethernet
port. If enabled, the test does NOT measure the leakage current of the
data connection. In this test, the mains voltage is applied to the data
connection and leakage current is then measured from the DUT
enclosure to protective earth, from DUT applied parts to protective
earth, and (for AAMI standard) between interconnected patient leads.
When measuring the mains-on-applied-part leakage, ES601
Plus
will
connect AUX1 to protective earth, rather than isolated mains.
Manual Testing/Chapter 5
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