ARABIC
Electromagnetic Compatibility Information
The device satises the EMC requirements of the international standard IEC
60601-1-2. The requirements are satised under the conditions described in
the table below. The device is an electrical medical product and is subject
to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications
equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or
between other electrical equipment.
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specied below. The customer or the user of the device should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment –
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
uctuations/
icker emissions
IEC 61000-3-3
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or the user of the device should assure that it is
used in such an environment.
Immunity test IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
IP27
-
WEEE
Electrostatic
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short interruptions and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
Group 1 The device uses RF energy only for
Class B The device is suitable for use in all
N/A
N/A
test level
± 8 kV contact
±2 kV, ±4 kV,
±8 kV,
±15 kV air
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
± 1 kV differ-
ential
mode
± 2 kV common
mode
< 5% UT
(>95% dip
in UT)
for 0.5 cycle
40% UT
(60% dip
in UT)
for 5 cycle
70% UT
(30% dip
in UT)
for 25 cycle
<5% UT
(>95% dip
in UT)
for 5 secretary
30 A/m;
50Hz or 60Hz
guidance
its internal function.
Therefore, its emissions are very low
and are not likely to cause any interference in nearby electronic equipment.
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Compliance level
± 8 kV
contact
±2 kV,
±4 kV,
±8 kV,
±15 kV air
N/A
N/A
N/A
30 A/m;
50Hz
or 60Hz
Electromagnetic environment - guidance
Floors should be wood,
concrete or ceramic tile.
If oors are covered
with synthetic material,
the relative humidity
should be at least 30 %.
Power frequency magnetic elds should be
at levels charactertic
of a typical location in
a typical commercial or
hospital environment.
Table 3
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or the user of the device should assure that it is
used in such an environment.
Immunity
test
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
RF
Wireless
Communication
Equipment
IEC
61000-4-3
IEC 60601 test
level
3 Vrms
150 kHz
to 80 Mhz
10 V/m
80 MHz
to 2.7 Ghz
380MHz,
27V /m
450MHz,
28V /m
710MHz,745
MHZ, 780MHz
9V/m
810MHz,870
MHZ, 930MHz
28V/m
1720MHz,
1845 MHZ,
1970MHz
28V/m
2450MHz,
28V /m
5240MHz,
5500 MHZ,
5785MHz
9V/m
Compliance Electromagnetic
N/A
10 V/m
380MHz,
27V /m
450MHz,
28V /m
710MHz,
745 MHZ,
780MHz 9V/m
810MHz,
870 MHZ,
930MHz 28V/m
1720MHz,
1845 MHZ,
1970MHz
28V/m
2450MHz,
28V /m
5240MHz,
5500 MHZ,
5785MHz
9V/m
environment –
guidance
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the device,
including cables, than
the recommended
separation distance
calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended
separation distance
3.5
√P
d=
1
E
80 MHz to 800 MHz
7
√P
d=
1
E
800 MHz to 2.7 GHz
Where P is the maximum output power
rating of the transmitter
in watts (W) according to the transmitter
manufacturer and d
is the recommended
separation distance in
metres (m).
Field strengths from
xed RF transmitters,
as determined by an
electromagnetic site
survey, a should be
less than the compliance level in each frequency range.
Interference may occur
in the vicinity
of equipment marked
with the following symbol:
25557/DMT-4220
JOYTECH Healthcare CO., Ltd.
No.365, Wuzhou Road,
Yuhang Economic Development Zone,
Hangzhou City, 311100 Zhejiang, China
Made In China
Shanghai International Holding Corp.
GmbH (Europe) Eiffestrasse 80,
Table 4
Recommended separation distances between portable and mobile
RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which
radiated therefore disturbances are controlled. The customer or the user
of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter W
0.01 0.12 0.23
0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higer
frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects and people.
Separation distance according to frequency
of transmitter m
80MHz to 800MHz 800MHz to 2.7GHz
d=
3.5
E
√P
1
d=
7
√P
1
E
0197
20537 Hamburg - Germany
Importato da / Imported by / Importado por / Importado por /
Importé par / Importowane przez / Εισαγωγή από /
:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
55°C
IP27
-20°C
95% 1060 hPa
15% 700 hPa
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M25557-M-Rev.4-10.20
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