Page 5 of 34
SECG 5.0 AIO | User Manual
Standard/Application
The following table shows the standards for which SECG 5.0 AIO has been designed for, and
includes any limitations:
Standard
Clause(s)
Limitations/Notes
IEC 60601-2-25:2011
(Diagnostic)
201.12.4: All performance tests
except
：
◆
CMRR test and baseline
noise
➔
use WhaleTeq CMRR
series tester
◆
Test referring to the CTS
atlas (CAL/ANE
waveforms)*, CSE database
➔
use WhaleTeq MECG
series tester
*Note: for most tests CAL/ANE
waveforms are alternates. For
two tests may be required
(201.12.4.102.3, test of lead
networks; and 201.12.4.105.3
test of ringing from mains notch
filter)
For 201.12.4.101 (large dc
offset test), the SECG is
limited to ±1Vdc. However,
this is almost certainly
enough to exceed the point
of saturation.
For the test circuit in figure
201.110, switch position A is
not
provided.
This
is
considered an error in the
standard due to the loading
effect of R2. Instead the DC
offset is provided in series
with output as per Figure
201.106.
IEC 60601-2-27:2011
(Patient monitoring)
201.7.9.2.9.101 b), 4) and 6)
(special test waveforms for Figure
201.101)
201.12.1.101, all performance
tests except baseline noise and
CMRR tests
No known limitations
IEC 60601-2-47:2012
(Ambulatory)
201.12.4, all tests except CMRR
test
No known limitations
ANSI/AAMI EC 13
2002/(R)2007/C2008
All performance tests except
CMRR test and as noted right
See below for Clauses 5.1.4
n) and 5.2.9.1 f), g)
1
General limitation: this equipment is designed for use with isolated ECG circuits, as are
generally provided for medical ECG. If applied to a non-isolated circuit, the noise may be
excessive.
1
5.1.4 n) Fast QRS: The sampling rate is limited to 0.2ms, some distortion of the pulse is possible below
6ms.
5. 2.9.1 f), g): Functionality is not included at this time; note the test is not applicable to most ECG
systems
