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Guidance and manufacturer's declaration - electromagnetic immunity
The CARDIOAfib (
02009200000100) is intended for use in the electromagnetic environment specified below. The
customer or the user of the CARDIOAfib (
02009200000100) should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test level
Compliance level
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
150 kHz to 80 MHz:
150 kHz to 80 MHz:
recommended separation distance calcula-
3Vrms
3Vrms
Conducted RF
ted from the equation appropriate for the
6Vrms (in ISM and
6Vrms (in ISM and
IEC 61000-4-6
frequency of the transmitter.
amateur radio bands)
amateur radio bands)
Recommended separation distances:
80% Am at 1kHz
80% Am at 1kHz
d = 0.35 √P
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2,7 GHz
d = 2.3 √P
Where p is the maximum output power
rating of the transmitter in watts (W) accor-
ding to the transmitter manufacturer and
d is the recommended separation distance
Radiated RF
10V/m,
10V/m,
in metres (m). Field strengths from fixed RF
IEC 61000-4-3
80% Am at 1kHz
80% Am at 1kHz
transmitters, as determined by an electro-
magnetic 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:
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.
a
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 as-
sess 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 device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Recommended separation distances between portable and mobile RF communications equipment and the device.
The CARDIOAfib (
02009200000100) is intended for use in an electromagnetic environment in which radiated RF di-
sturbances are controlled. The customer or the user of the CARDIOAfib (
02009200000100) can help prevent electro-
magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmittters) and the device as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output
power of transmitter
150 kHz to 80 MHz
80MHz to 800MHz
800MHz to 2.7GHz
(W)
d=3.5 √P
d=1.2 √P
d=2.3 √P
0,01
0.12
0.12
0,1
0.38
0.38
1
1.2
1.2
10
3.8
3.8
100
12
12
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.
Guidance and manufacturer's declaration - electromagnetic immunity
The
is intended for use in the electromagnetic environment specified below. The
CARDIOAfib (
02009200000100)
customer or the user of the
CARDIOAfib (
02009200000100)
, should assure that it is used in such an environment.
Test frequency
Band
a
)
Service
a
)
Modulation
b
)
Modulation
b
) (W)
Distance (m)
(MHz)
(MHz)
Pulse
385
380 – 390
TETRA 400
modulation
b
)
1,8
0,3
18 Hz
FM c)
GMRS 460,
±5 kHz
450
430 – 470
2
0,3
FRS 460
deviation
1 kHz sine
710
Pulse
LTE Band
745
704 – 787
modulation
b
)
0,2
0,3
13, 17
217 Hz
780
Radiated RF
IEC61000-4-3
GSM
(Test
810
800/900,
specifications
Pulse
TETRA 800,
for
870
800 – 960
modulation
b
)
2
0,3
iDEN 820,
ENCLOSURE
18 Hz
PORT
CDMA 850,
930
LTE Band 5
IMMUNITY to
RF wireless
communica-
GSM 1800;
1 720
tions
CDMA 1900;
Pulse
1 700 –
GSM 1900;
equipment)
1 845
modulation
b
)
2
0,3
1 990
DECT;
217 Hz
LTE Band 1, 3,
1 970
4, 25; UMTS
Bluetooth,
WLAN,
Pulse
2 400 –
2 450
802.11 b/g/n,
modulation
b
)
2
0,3
2 570
RFID 2450,
217 Hz
LTE Band 7
5 240
Pulse
5 100 –
WLAN 802.11
5 500
modulation
b
)
0,2
0,3
5 800
a/n
217 Hz
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 MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT,
and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Mi-
nimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
6
E =
√P
d
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST
LEVEL in V/m.
SAFETY INFORMATION
The symbols below can be found in the Instruction Manual as well as on labels and other components.
SYMBOL
DESCRIPTION
SYMBOL
DESCRIPTION
"PLEASE REFER TO THE INSTRUCTIONS FOR USE" symbol
Catalogue Number
Symbol for "COMPLIES WITH MDD 93/42/EEC as
"TYPE BF APPLIED PART" symbol
amended by directive 2007/47/EC"
0068
Storage and transport humidity symbol
"MANUFACTURER" symbol
Storage and transport temperature symbol
SN
Symbol for "SERIAL NUMBER"
Caution
Symbol for "DIRECT CURRENT"
Lot number
Keep dry
Protected against solid objects over 12 mm
and against vertically falling drops of water.
Latex free
Appliance date of production: The second pair of digits in the lot number identifies the year, the third pair identifies the month.
(e.g. LOT 1016100001: 16=2016; 10= October).
THIS BLOOD PRESSURE MONITOR COMPLIES WITH:
- The device has been verified and it conforms to the provisions of the EC council directive 93/42/EEC (Medical Device Directi-
ve), its Annex I essential requirements and corresponding standards.
- EN 1060-1: 1995/A2: 2009 Non-invasive sphygmomanometers - Part 1 - General requirements.
- EN 1060-3: 1997/A2: 2009 Non -invasive sphygmomanometers - Part 3 - Supplementary requirements for electro-mechanical
blood pressure measuring systems.
- EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test Procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers.
THIS PRODUCT COMPLIES WITH THE DIRECTIVE 2012/19/EU.
The crossed bin symbol on the appliance indicates that the product, at the end of its life, must be disposed of
separately from domestic waste, either by taking it to a separate waste disposal site for electric and electronic
appliances or by returning it to your dealer when you buy another similar appliance. The user is responsible for
taking the appliance to a special waste disposal site at the end of its life. If the disused appliance is collected
correctly as separate waste, it can be recycled, treated and disposed of ecologically; this avoids a negative impact
on both the environment and health, and contributes towards the recycling of the product's materials. For further
information regarding the waste disposal services available, contact your local waste disposal agency or the shop where you
bought the appliance.
THIS PRODUCT COMPLIES WITH EU DIRECTIVE 2006/66/EC
The crossed bin symbol on the batteries indicates that, at the end of their life, they must be disposed of separately
from domestic waste, either by taking them to a separate waste disposal site for batteries or by returning them
to your dealer when you buy similar rechargeable or non-rechargeable batteries. The chemical symbols Hg, Cd,
Pb, printed under the crossed bin symbol, indicate the type of substance contained in the batteries: Hg=Mercury,
0.23
Cd=Cadmium, Pb=Lead. The user is responsible for bringing batteries, at the end of their life, to the appropriate collection
facilities in order to facilitate treatment and recycling. The correct disposal of your old toy will help prevent potential negative
consequences for the environment and human health and favour the recycling of the materials of which the product is made.
0.73
Illegal disposal of the product by the user will damage the environment and human health. For further information regarding
the waste disposal services available, contact your local waste disposal agency or the shop where you bought the appliance.
2.3
POUCH CLEANING SYMBOLS
7.3
Wash by hand in cold water,
23
Do not bleach,
30° C
Do not tumble dry,
line drying,
Do not iron,
Do not dry clean.
IMMUNITY
TEST LEVEL
(V/m)
27
28
9
28
28
28
9
0068
PIKDARE S.p.A.
Via Saldarini Catelli, 10
22070 - Casnate con Bernate (CO) - Italy
www.picsolution.com
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