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Symbol Descriptions
The CE mark and
Notified Body
Registration
Numbers, the
requirement of Annex
II from Medical
Device Directive
93/42/EEC are met.
Please read the
instructions for use
BF type applied part
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
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic
emissions
Not applicable
IEC 61000-3-2
Voltage
fluctuations/
Not applicable
flicker emissions
IEC 61000-3-3
Indicates this
device is subject to
the Waste
Electrical and
Electronic
Equipment
Directive in the
European Union.
Paper Recycling
Battery Recycling
Electromagnetic environment – guidance
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.
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.
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.
Do not reuse
Immunity test
Manufacturer
Authorised
representative
in the
Conducted
3 Vrms
European
RF
community
150 kHz to
IEC
80 MHz
61000-4-6
3 V/m
Radiated RF
80 MHz to
IEC
2,5 GHz
61000-4-3
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.
Compliance
IEC 60601
Electromagnetic environment – guidance
test level
level
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
d = 1,2
d = 1,2
Not
d = 1,2
applicable
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).
3 V/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
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