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.
Do not reuse
Caution
Please read the instructions for use
Paper Recycling
Manufacturer
To protect the environment, dispose of
empty batteries at your retail store or at
appropriate collection sites according to
national or local regulations.
BF type applied
part
Authorized representative in the European
community
IP22
Classification for water ingress and particulate matter.
Manufacturer’s declaration-electromagnetic emissions
The TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7xy 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 TH7xy 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 TH7xy 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 TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7xy 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, 60Hz)
magnetic field IEC
61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The TH7xy 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 TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7xy 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
√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
TH7xy series is used exceeds the applicable RF compliance level above, the TH7xy 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 TH7xy series.
Recommended separation distance between
portable and mobile RF communications equipment and the
TH7xy series
The TH7xy 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 TH7xy series can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the TH7xy series as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d =1,2
√P
80 MHz to 800 MHz
d =1,2
√P
800 MHz to 2,7 GHz
d =2,3
√P
0,01
N/A
0,12 0,23
0,1
N/A
0,38 0,73
1
N/A
1,2 2,3
10
N/A
3,8 7,3
100
N/A
12 23
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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for 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.
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7xy series should assure that it is used in such an environment.
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance LEVEL
(V/m)
(for home healthcare)
385 380
–390
TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27
27
450 430
–
470
GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2 0,3 28
28
710
704 – 787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2 0,3 9
9
745
780
810
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2 0,3 28
28
870
930
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28
28
1 845
1 970
2 450
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2 0,3 28
28
5 240
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9
9
5 500
5 785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.
Содержание TH709L
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