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Single Channel ECG Test System | User Manual
If users would like to test with unused electrodes connected to P6, it should be
possible to create a simple extension to the terminal marked RL/N (P6) for
connecting unused electrodes.
3.3
IEC 60601-2-27
Please note this section is written for IEC 60601-2-27:2005. In order to meet
publishing deadlines, it is not yet updated to the latest standard. However, the
concepts remain the same.
The following table provides some guidance on actual tests to IEC 60601-2-27,
including highlighting some apparent limitations in the standard.
Clause
Test
Guidance
6.8.2 bb) 4) Heart rate
accuracy in
response to
irregular rhythm
The waveforms required to verify manufacturer
claims (A1 to A4, originally from ANSI/AAMI)
can be accessed
using “Special” button (under
the list of Main Functions, see 2.6.1). These
waveforms have been obtained from the
Physionet website.
6.8.2 bb) 5) Response time
to a change in
heart rate
The results of this test can occasionally be on
the limit. It is possible to have time delays of up
to 1s between changing the rate on the PC and
the actual output, as the WhaleTeq system
implement changes only at the end of a cycle to
ensure a smooth transition. It is also possible to
have delays of several seconds in the patient
monitor. If the result is within 1s of the limit,
more accurate methods may be needed such as
oscilloscope monitoring of the real time ECG
signal (at BNC2) and using this to determine the
start time.
6.8.2 bb) 6) Time to alarm
for tachycardia
The waveforms required to verify manufacturer
claims (B1, B2 with half and double amplitude)
can be accessed usi
ng “Special” button in the
“Main Function”. These waveforms are
downloaded from Physionet website and are
identical to the AAMI/ANSI waveforms. Note
that the preceding “normal condition”
(80bpm)
