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
Manufacturer
BF type applied part
To protect the environment, dispose of empty
batteries at your retail store or at appropriate
collection sites according to national or local
regulations.
Paper Recycling
IP22
Classification for water ingress and
particulate matter.
Manufacturer’s declaration-electromagnetic emissions
The TH5xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH5xy series should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The TH5xy 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 TH5xy 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.
Manufacturer’s declaration-electromagnetic immunity
The TH5xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH5xy 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 TH5xy 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 TH5xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH5xy series should assure that is used in such and environment.
Immunity test
IEC 60601 test level
Compliance 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
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,
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.
