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 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.
Authorized
representative in
the European
community
Caution
Please read the
instructions for use
Paper Recycling
Manufacturer
BF type applied part
IP22
Classification for
water ingress and
particulate matter.
To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites
according to national or local regulations.
Manufacturer’s declaration – electromagnetic immunity
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the TH2xyz series should assure that it is used in
such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment –
guidance
(for home healthcare environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%
Power
frequency(50, 60
Hz) magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The
TH2xyz series
power frequency
magnetic fields should be at levels
characteristic of a typical location in a
typical home healthcare environment.
Manufacturer’s declaration – electromagnetic immunity
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the TH2xyz series should assure that it is used in
such an environment.
Immunity test
IEC 60601 test
level
Complian
ce level
Electromagnetic environment – guidance
(for home healthcare environment)
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
10 V/m
80 MHz –
2,7 GHz
80 % AM at
1 kHz
Recommended separation distance:
d = 1,2
√P
d = 1,2
√P
80MHz to 800 MHz
d = 2,3
√P
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,
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:
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
TH2xyz series
is used exceeds the applicable RF compliance level above, the
TH2xyz 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
TH2xyz series
.
Manufacturer’s declaration-electromagnetic emissions
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below.The customer or the user of the TH2xyz series should assure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The TH2xyz 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.
RF emissions
CISPR 11
Class B
The TH2xyz 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.
