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Caution Please read the instructions for use. Do not reuse
Manufacturer
BF type applied part Battery Recycling Paper Recycling
The CE mark and Notified
Body Registration Numbers,
the requirement of Annex II
from Medical Device
Directive 93/42/EEC are
met.
Indicates this device is subject to the
Waste Electrical and Electronic
Equipment Directive in the European
Union. To protect the environment,
dispose of useless device at appropriate
collection sites according to national or
local regulations.
Authorized representative
in the European
community.
Guidance and manufacturer’s declaration – electromagnetic emissions
The TH8xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the
TH8xyz series should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1
Class B
The TH8xyz series 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.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Not applicable
The TH8xyz series is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Symbol Descriptions
Guidance and manufacturer’s declaration – electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the
TH8xyz series should assure that it is used in such an environment.
Immunity test
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Not
applicable
3 V/m
IEC 60601
test level
3 Vrms
150 kHz
to 80 MHz
3 V/m
80 MHz
to 2,5 GHz
Portable and mobile RF communications equipment should be used no closer to
any part of the TH8xyz series, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
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 meters (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:
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1,2
d = 1,2
d = 2,3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a. 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 TH8xyz series is used exceeds the applicable RF compliance level above, the TH8xyz
series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the TH8xyz series.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the
TH8xyz series should assure that it is used in such an environment.
Immunity test Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
6 kV contact
8 kV air
6 kV contact
8 kV air
Not applicable
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.
Surge
IEC 61000-4-5
Not applicable
IEC 60601
test level
2 kV for power
supply lines
1 kV for input/
output lines
1 kV line(s) to
line(s)
2 kV line(s) to
earth
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the TH8xyz series requires
continued operation during power mains interruptions, it is
recommended that the TH8xyz series be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Not applicable
3 A/m 3 A/m
Recommended separation distances between portable and
mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM
The TH8xyz series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the TH8xyz series can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the TH8xyz series as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Separation distance according to frequency of transmitter
m
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
80 MHz to 800 MHz150 kHz to 80 MHz 800 MHz to 2,5 GHz
d = 1,2 d = 1,2 d = 2,3
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