*This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone,
transceiver or radio control products. If you have to do so, the device should be observed to verify normal
operation.
*The use of accessories and power cord other than those specified, with the exception of cables sold by the
manufacturer of the equipment or system as replacement parts for internal components, may result in
increased emissions or decreased immunity of the equipment or system.
WARNINGS!
The device complies with the IEC 60601-1-2 standard for electromagnetic compatibility. Please do not let
thermometer become source of the disturbance, also try your best avoid source of the disturbance. Inquire at
COCET for details on this measurement data. We reserve the right to make technical and design changes in
the course of continuous product improvement.
ELECTROMAGNETIC COMPATIBILITY
The digital thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the digital thermometer should assure that it is used in such an environment.
Guidance and manufacturer´s declaration – electromagnetic emission
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations /
flicker
emissions
IEC 61000-3-3
Group 1
Class B
N/A
N/A
Emissions test
Compliance
Electromagnetic environment – guidance
The digital thermometer uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The digital thermometer is suitable for use in all establishments,
including domestic establish-ments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
THE THERMOMETER WAS DESIGNED AND MANUFACTURED IN COMPLIANCE WITH THE FOLLOWING
EUROPEAN STANDARDS
IEC 60601-1
IEC 60601-1-2
ISO 80601-2-56
ISO15223-1
Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
medical electrical equipment Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body temperature measurement
ISO15223-1 Medical devices--symbols to be used with medical device labels,labelling
and information to be suppliedlied--Part 1:General requirements The product fulfills the
requirements of Directive 93/42/EEC.
The digital thermometer are intended for use in the electromagnetic environment specified below. The customer or the
user of the digital thermometer should assure that it is used in such an environment.
Guidance and manufacturer´s declaration – electromagnetic immunity
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage
variationson
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50/60Hz
30 A/m, 50/60Hz
0 % UT
(100 % dip in UT )
for 0.5 cycle at 0°,
45°, 90°, 135°,180°,
225°, 270°, and 315°
0 % UT
(100 % dip in UT )
for 1 cycle at 0
°
70 % UT
(30 % dip in UT )
for 25/30 cycles at 0
°
0 % UT
(100 % dip in UT )
for 250/300 cycle at 0
°
0 % UT
(100 % dip in UT )
for 0.5 cycle at 0°,
45°, 90°, 135°,180°,
225°, 270°, and 315°
0 % UT
(100 % dip in UT )
for 1 cycle at 0
°
70 % UT
(30 % dip in UT )
for 25/30 cycles at 0
°
0 % UT
(100 % dip in UT )
for 250/300 cycle at 0
°
± 0.5 kV, ± 1 kV
differential mode
line-line
± 0.5 kV, ± 1 kV
differential mode
line-line
± 8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
± 2 kV for power
supply lines100 kHz
repetition frequency
± 1 kV for input/
output lines
± 2 kV for power
supply lines
100 kHz repetition
frequency
± 8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Immunity test
EC 60601
test level
Compliance level
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the digital
thermometer product name requires
continued operation during power mains
interruptions, it is recommended that the
digital thermometer be powered from an
uninterruptible power supply or a battery.
environment.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.
The digital thermometer is intended for use in the electromagnetic environment specified below. The customer or the
user of the digital thermometer should assure that it is used in such an environment.
Guidance and manufacturer´s declaration – electromagnetic immunity
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 Vrms 150 kHz to
80 MHz outside
ISM bandsa
10 V/m
80 MHz to 2.7 GHz
3 Vrms
150 kHz to 80 MHz
6 Vrms 150 kHz to
80 MHz outside
ISM bandsa
10 V/m
Immunity test
EC 60601
test level
Compliance level
Electromagnetic environment -
guidance
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
b.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended
separation distance for transmitters in these frequency ranges.
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
c.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
digital thermometer is used exceeds the applicable RF compliance level above, the TT-CL011 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the digital thermometer .
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,
d.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a.
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to
Portable and mobile RF communications
equipment should be used no closer to any
part of the digital thermometer , including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
80MHz to 800MHz
Recommended separation distance
800MHz to 2.7GHz
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 fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range
b
Interference may occur in the vicinity of
equipment marked with
the following symbol:
Rated maximum output
of transmitter W
Separation distance according to frequency of transmitter/m
150kHz to 80MHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
80kHz to 800MHz
800MkHz to 2.5GHz
The digital thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the digital thermometer can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
digital thermometer as recommended below, according to the maximum output power of the communications
equipment.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
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.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Recommended separation distances between portable
and mobile RF communications equipment and the digital thermometer
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum
distance between RF wireless communications equipment and the device as recommended below, according to the
maximum output power of the communications equipment.
Recommended separation distances between RF wireless communications equipment
Frequency
MHz
385
1.8
2
0.2
2
2
2
0.2
0.3
0.3
0.3
0.3
0.3
0.3
0.3
27
28
9
28
28
28
9
27
28
9
28
28
28
9
450
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5780
Maximum
Power W
Distance
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
p
Recommended separation
distance
RF wireless 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.
Where P is the maximum output
power rating of the ransmiter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitter, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range. Interference
may occur in the vicinity of
equipment marked with
the following symbol:
KFT-03/04-SMS-EN
