ELECTROMAGNETIC COMPATIBILITY INFORMATION
This device is suitable for home healthcare environment and professional healthcare facility environment.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
The essential performance is the digital thermometer can offer the temperature measurement.
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields,
near the medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device in case the distance is
shorter.
Guidance and manufacturer's declaration – electromagnetic immunity
Phenomenon
Professional healthcare
facility environment
Home healthcare
facility environment
Basic EMC standard
or test method
The device is suitable for use in the specified electromagnetic environment and it meets
the following immunity test levels. Higher immunity levels may cause the device's essential
performance lost or degraded.
Radiated RF
EM fields
Proximity fields
from RFwireless
communications
equipment
Electrostatic
discharge
IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
3V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
10V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
1kHz or 2Hz can be specified by
the manufacturer
See the RF wireless communication equipment
table in "Recommended minimum
separation distances".
30A/m; 50 Hz or 60Hz
NA
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
NA
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. output signal output lines connected directly to outdoor cables
IEC 61000-4-3
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-3
IEC 61000-4-8
Electric fast
transients bursts
Surges
Rated power
frequency
magnetic fields
Guidance and manufacturer's declaration – electromagnetic emissions
Phenomenon
Home healthcare environment
Profession healthcare
facility environment
The device is suitable for use in the specified electromagnetic environment and it has
meets the following standard's emission requirements.
Home healthcare
environment
CISPR 11, Group 1,
Class A or B
CISPR 11, Group 1, Class B
Harmonic distortion
IEC 61000-3-2,
Class A or not applicable
NA
NA
Voltage fluctuations
and flicker
IEC 61000-3-3
or not applicable
Conducted
disturbances
induced by
RF fields
NA
NA
NA
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. all patient-coupled cables
4. SIP/SOP whose maximum cable length ≥ 3m
IEC 61000-4-6
IEC 61000-4-11
IEC 61000-4-11
Voltage dips
Voltage
interruptions
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Recommended minimum separation distances
Test frequency
(MHz)
Nowadays, many RF wireless equipments are being used in various healthcare locations
where medical equipment and/or systems are used. When they are used in close proximity
to medical equipment and/or systems, the medical equipment and/or systems' basic safety
and essential performance may be affected. This device has been tested with the immunity
test level in the below table and meet the related requirements of IEC 60601-1-2:2014. The
customer and/or user should help keep a minimum distance between RF wireless commun-
ications equipment and this device as recommended below.
385
450
710
745
780
810
870
930
1720
1845
1970
5500
5240
2450
5785
Band
(MHz)
380-390
430-470
704-787
800-960
1700-1990
5100-5800
2400-2570
Service
TETRA 400
GMRS 460
FRS 460
LTE Band
13, 17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3
4, 25; UMTS
WLAN 802.11
a/n
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Modulation
Pulse
modulation
18Hz
FM ± 5 kHz
deviation
1 kHz sine
Pulse
modulation
217Hz
Pulse
modulation
18Hz
Pulse
modulation
217Hz
Pulse
modulation
217Hz
Maximum
power(W)
1.8
2
0.2
2
2
0.2
2
Distance
(m)
0.3
0.3
0.3
0.3
0.3
0.3
0.3
Immunity
test level
(V/m)
27
28
9
28
28
9
28
Pulse
modulation
217Hz
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