MedNet EC-REP GmbH
Borkstra
β
e 10, 48163 M
ϋ
nster, Germany
TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Road, Wugu Dist., 24888 New Taipei City TAIWAN www.taidoc.com
Importer:
Plot of cumulative size distribution of results
0.1
1
10
100
0
20
40
60
80
100
0
20
40
60
Cumulative Fraction (%)
Mean Mass Fraction (%)
AeroDynamic Diameter (µm)
individual tests
mean
Reference to Standards:
• Electric Safety Standards EN 60601-1
• Electromagnetic Compatibility according to EN 60601-1-2
• Particle Size according to EN 13544-1, clause 6.8.2
The device is a class IIa medical device according to Medical Device Directive 93/42/EEC.
• Please contact your dealer for assistance with any other difficulties.
• Performance may vary with medication such as suspensions or high viscosity. See
medication supplier’s data sheet for further details.
• Performance information provided by the manufacturer in accordance with the
standard EN 13544-1:2007 may not apply to drugs supplied in suspension or high
viscosity form. Please consult the drug supplier for more information.
Note
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity
The TD-7013 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the TD-7013 should assure that it is used in such an environment.
Immunity
test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast
transient/burst IEC
61000-4-4
Surge IEC 61000-4-5
Voltage Dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
Power frequency (50, 60
Hz) magnetic field IEC
61000-4-8
Contact: ±8 kV
Air±2 kV,±4 kV,±8 kV,±15
kV
+ 2kV for power supply
lines
+ 1kV for input/output
lines
+ 0.5kV, +1kV line(s) to
line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
Voltage dips:
0 % U
T
; 0,5 cycle
0 % U
T
; 1 cycle
70 % U
T
; 25/30 cycles
Voltage interruptions:
0 % U
T
; 250/300 cycle
30 A/m
50 Hz or 60 Hz
Contact: ±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
+ 2kV for power supply
lines
Not applicable
+ 0.5kV, +1kV line(s) to
line(s)
Not applicable
Voltage dips:
0 % U
T
; 0,5 cycle
0 % U
T
; 1 cycle
70 % U
T
; 25/30 cycles
Voltage interruptions:
0 % U
T
; 250/300 cycle
30 A/m
50 Hz
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Mains power quality should be that of a typical home
healthcare environment.
Mains power quality should be that of a typical home
healthcare environment.
Mains power quality should be that of a typical home
healthcare environment. If the user of the TD-7013 requires
continued operation during power mains interruptions, it is
recommended that the TD-7013 be powered from an
uninterruptible power supply or a battery.
The TD-7013 power frequency magnetic fields should be at
levels characteristic of a typical location in a typical home
healthcare environment.
IEC 60601
test level
Electromagnetic environment-guidance
(for home and professional healthcare environment)
Compliance
level
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.
Manufacturer’s declaration-electromagnetic immunity
The TD-7013 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the TD-7013 should assure that it is used in such and environment.
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
Portable and mobile RF communications
equipment should be used no closer to any part of the
TD-7013 including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
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).
Interference may occur in the vicinity of equipment marked
with the following symbol:
Immunity
test
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
IEC 60601
test level
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Compliance
level
Electromagnetic environment-guidance
(for home and professional healthcare environment)
Recommended separation distance between
portable and mobile RF communications equipment and the Lifechek TD-7013
The Lifechek TD-7013 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF
disturbances are controlled. The customer or the user of the Lifechek TD-7013 can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the Lifechek TD-7013 as recommended
below, according to the maximum output power of the communications equipment.
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.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for 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.
Separation distance according to frequency of transmitter
m
Rated maximum output
power of transmitter
(W)
0,01
0,1
1
10
100
150 kHz to 80 MHz
d =1,2√P
0,12
0,38
1,2
3,8
12
80 MHz to 800 MHz
d =1,2√P
0,12
0,38
1,2
3,8
12
800 MHz to 2,7 GHz
d =2,3√P
0,23
0,73
2,3
7,3
23
The TD-7013 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the TD-7013 should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
(for home and professional healthcare environment)
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Compliance
The TD-7013 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 TD-7013 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 emissions
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
385
450
710
745
780
810
870
930
1 720
1 845
1 970
2 450
5 240
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.
The Lifechek TD-7013 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the
Lifechek TD-7013
should assure that it is used in such an environment.
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
Compliance
LEVEL
(V/m)
(for home
healthcare)
27
28
9
28
28
28
9
Immunity
test
LEVEL
(V/m)
27
28
9
28
28
28
9
Distance
(m)
0,3
0,3
0,3
0,3
0,3
0,3
0,3
Maximum
power
(W)
1,8
2
0,2
2
2
2
0,2
Pulse modulation
b)
18 Hz
FM
c)
±5 kHz deviation
1 kHz sine
Pulse modulation
b)
217 Hz
Pulse modulation
b)
18 Hz
Pulse modulation
b)
217 Hz
Pulse modulation
b)
217 Hz
Pulse modulation
b)
217 Hz
TETRA 400
GMRS 460, FRS 460
LTE Band 13, 17
GSM 800/900, TETRA 800,
iDEN 820, CDMA 850,
LTE Band 5
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE Band
1, 3, 4, 25; UMTS
Bluetooth, WLAN, 802.11 b/g/n,
RFID 2450, LTE Band 7
WLAN 802.11
a/n
380 – 390
430 – 470
704 – 787
800 – 960
1 700 – 1 990
2 400 – 2 570
5 100 – 5 800
B.E.K.
Sağlık Ürünleri Eğitim Turizm Emlak ve Danıșmanlık Hizmetleri San. ve Tic. Ltd. Ști.
Ahmet Yesevi Mah. Sanayi Cad. Akarsu İș Merkezi No: 523/21 Nilüfer/Bursa/TÜRKİYE
Tel: +90 444 9 235 e-posta: info@beksaglik.com.tr www.lifechek.com.tr
