Vitrolife EmbryoScope - Page 73

EmbryoScope time-lapse incubator
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The two tables below contain the applicable information required for a system other than those
specified for use only in a shielded location and for systems that are not life-supporting.
Guidance and manufacturer’s declaration – electromagnetic immunity
The EmbryoScope time-lapse incubator is intended for use in the home healthcare environment
specified below. The customer or the user of the EmbryoScope time-lapse incubator should
assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Conducted RF
IEC 61000-4-6:2013
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM and
amateur radio bands
between 150 kHz to
80 MHz
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM and
amateur radio bands
between 150 kHz to
80 MHz
EUT remained safe during the test in
normal operational mode and in alarm
mode.
It is recommended that portable and
mobile RF communications equipment
is used no closer to any part of the
EmbryoScope time-lapse incubator,
including cables, than 0.3 metres,
which corresponds to the distance of
the test level applied. Otherwise,
degradation of the performance of the
EmbryoScope time-lapse incubator
could result.
Field strengths from fixed RF
transmitters as determined by an
electromagnetic site survey
1
should be
less than the compliance level in each
frequency range.
Radiated RF
IEC 61000-4-3:2006 +
A1:2007 + A2:2010
10 V/m
80 MHz to 2.7 GHz
10 V/m
80 MHz to 2.7 GHz
Radiated RF IEC 61000
-4-3:2006 + A1:2007 + A2:2010
– Proximity fields from RF wireless
communications equipment
TETRA 400
385 MHz, PM, 18 Hz,
1.8 W, 27 V/m
385 MHz, PM 18 Hz,
1.8 W, 27 V/m
GMRS 460
FRS 460
450 MHz, FM,
± 5 kHz dev., 1 kHz
sine, 2 W, 28 V/m
450 MHz, FM,
± 5 kHz dev., 1 kHz
sine, 2 W, 28 V/m
LTE Band 13
LTE Band 17
710/745/780 MHz,
PM, 217 Hz, 0.2 W,
9 V/m
710/745/780 MHz,
PM, 217 Hz, 0.2 W,
9 V/m
GSM 800
GSM 900
TETRA 800
iDEN 820
CDMA 850
LTE Band 5
810/870/930 MHz,
PM, 18 Hz, 2 W,
28 V/m
810/870/930 MHz,
PM, 18 Hz, 2 W,
28 V/m
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE Band 1
LTE Band 3
LTE Band 4
LTE Band 25
1720/1845/1970
MHz, PM, 217 Hz,
2 W, 28 V/m
1720/1845/1970
MHz, PM, 217 Hz,
2 W, 28 V/m