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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.
Caution
Manufacturer
Authorized representative in
the European community
Manufacturer's declaration-electromagnetic emissions
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz series should assure that it is used in such an environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Manufacturer's declaration-electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz series should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Electrostatic
Contact:±8 kV
discharge(ESD)
Air±2 kV,±4 kV,±8 kV,±15 kV
IEC 61000-4-2
Power
30 A/m
frequency(50, 60
50 Hz or 60 Hz
Hz) magnetic field
IEC 61000-4-8
Manufacturer's declaration-electromagnetic immunity
Please do not dispose of the
product in the household waste
at the end of its useful life.
Disposal can take place at
appropriate collection points
provided in your country.
Please read the instructions for
use
To protect the environment,
dispose of empty batteries at
your retail store or at
appropriate collection sites
according to national or local
regulations.
IP22
Classification for water ingress and particulate matter.
Electromagnetic environment-guidance
(for home healthcare environment)
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.
Compliance level
Electromagnetic
environment-guidance
(for home healthcare
environment)
Contact:±8 kV
Floors should be wood, concrete or
Air±2 kV,±4 kV,±8 kV,±15 kV
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%
30 A/m
The TH8xyz series power
50 Hz and 60 Hz
frequency magnetic fields should be
at levels characteristic of a typical
location in a typical home healthcare
environment.
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz series should assure that is used in such and environment.
Immunity test
IEC 60601 test
level
Do not reuse
Radiated RF
10 V/m
IEC 61000-4-3
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Paper
Recycling
BF type
applied part
NOTE1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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 re-orienting or relocating the TH8xyz series.
portable and mobile RF communications equipment and the TH8xyz series
The TH8xyz series is intended for use in an electromagnetic environment (for home healthcare) 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
0,01
0,1
1
10
Compliance level
Electromagnetic environment-guidance
(for home healthcare environment)
10 V/m
Recommended separation distance:
80 MHz – 2,7 GHz
d = 1,2
80 % AM at 1 kHz
d = 1,2
80MHz to 800 MHz
d = 2,3
800MHz 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 fixed RF transmitters, as determined
by an electromagnetic site survey,
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Recommended separation distance between
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
d =1,2
d =1,2
N/A
0,12
N/A
0,38
N/A
1,2
N/A
3,8
should be less than
a
b
800 MHz to 2,7 GHz
d =2,3
0,23
0,73
2,3
7,3
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