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Electromagnetic compatibility
The product complies with the EMC-standard according to IEC60601-1-2, but the mobile communicat
ion devices’ emissions can disturb the product’s
functioning. For the proper functioning of the device please follow the instructions of the user manual.
Electromagnetic disturbance emission
T
HE
WIWE
MOBILE AND HEART DIAGNOSTIC DEVICE WAS MADE TO BE USED IN AN ELECTROMAGNETIC ENVIRONMENT WITH THE CONDITIONS BELOW
.
T
HE USER NEEDS TO ENSURE
,
THAT THE DEVICE IS FUNCTIONING WITH THESE CONDITIONS
.
Disutrbance emission examination
Compliance
Electromagnetic environment
– guideline
RF emissions,
MSZ EN 60601-1-2:2008, MSZ EN 55011:2010
Class B
Approved: 30-
1000MHz,
The WIWE device’s consumption is lower, than 75 W. Its disturbance
emission is negligible. so it won’t cause any disturbances in the
functioning of the device.
WIWE mobile diagnostic deivce is suitable to use in any kind of
establishment, including houses and establishments directly connected
to the low voltage network supplying the houses.
The WIWE mobile heart diagnostic device is not suitable to be connected
with other devices.
RF emissions, supply gateway
MSZ EN 60601-1-2:2008, MSZ EN 55011:2010
Class B
Approved: 0,15-30MHz
Overtone emissions
MSZ EN 60601-1-2:2008, MSZ EN 61000-3-2 :
100Hz-2kHz
[
non applicable]
Changes in voltage /flicker emissions
MSZ EN 60601-1-2:2008, MSZ EN 61000-3-3:2013
[
non applicable]
Electromagnetic disturbance allowance
T
HE
WIWE
MOBILE AND HEART DIAGNOSTIC DEVICE WAS MADE TO BE USED IN AN ELECTROMAGNETIC ENVIRONMENT WITH THE CONDITIONS BELOW
.
T
HE USER NEEDS TO ENSURE
,
THAT THE DEVICE IS FUNCTIONING WITH THESE CONDITIONS
.
Disturbance allowance examination
IEC 60601
examination level
Compliance
Electromagnetic environment - guideline
Electrostatic discharge (ESD)
MSZ EN 60601-1-2:2008
± 6 kV
on contact
± 8 kV
on strikeover
approved
Wood, concrete or ceramic floor case needed. If the floor is covered with
plastic, then the relative humidity should be at least 30 %.
Quick electrical transients/burst
MSZ EN 60601-1-2:2008
±2kV L, N–
reference
between earth
approved
The energetic quality of the network needs to be equal with the usual
used in commercial or hospital environment.
Shockwave (Surge)
MSZ EN 60601-1-2:2008
1kV L-N
approved
The energetic quality of the network needs to be equal with the usual
used in commercial or hospital environment.
Voltage breaking, short time voltage outages
fluctuations on the input supply wires
MSZ EN 60601-1-2:2008
100%, 60%, 30%
1, 5, 25 periods
approved
The energetic quality of the network needs to be equal with the usual
used in commercial or hospital environment. WIWE was made to use in
battery mode. At least 50 measurements can be done with it.
Magnetic field with network frequency
(50/60 Hz)
MSZ EN 60601-1-2:2008
3 A/m
non applicable
There is no part in the WIWE which is sensitive for the network’s
electromagnetic field.
Electromagnetic disturbance allowance
T
HE
WIWE
MOBILE AND HEART DIAGNOSTIC DEVICE WAS MADE TO BE USED IN AN ELECTROMAGNETIC ENVIRONMENT WITH THE CONDITIONS BELOW
.
T
HE USER NEEDS TO ENSURE
,
THAT THE DEVICE IS FUNCTIONING WITH THESE CONDITIONS
.
Disturbance
allowance
examiation
IEC 60601 1-2
examination level
Compliance
Electromagnetic environment - directive
Conducted RF
MSZ EN 60601-1-
2:2008
3Veff
0,15
–
80MHz
modulation:
2Hz, 80% AM
[3Veff] V
approved
The portable and mobile RF transmission deivces can only be used within a distance derived from
a formula based on the transmitter’s frequency.
Suggested distance for clearance
d=[3,5/V1]√P
d=[3,5/E1]√P 80 MHz –
800 MHz
d=[7/E1]√P 800 MHz –
2,5 GHz
where P is the highest capacity of the transmission output in Watts (W) and d is the suggested
distance for clearance in meters (m).
The field strength determined by local measurement, coming from the deplyoed RF
transmitters
a.
should be smaller than the compliance level in case of each frequency interval
b.
Disturbance can occur in the environment of devices with this symbol here:
Broadcasted RF
MSZ EN 60601-1-
2:2008
3 V/m
3V/m (0,08-
2,5GHz)
modulation:
2Hz, 80% AM
[3] V/m
approved
N
OTES
:
1.
I
N CASE OF
80
MH
Z AND
800
MH
Z THE HIGHER FREQUENCY INTERVAL
(
UPPER
)
NEEDS TO BE USED
.
2.
T
HESE ARE ONLY GUIDELINES
.
I
T IS POSSIBLE
,
THAT ELECTROMAGNETIC SPREADING CAN
’
T BE USED IN EVERY SITUATION
,
IT IS DEPENDENT ON THE OBJECTS IN THE ENVIRONMENT
,
THE SPATIAL LOCATION OF THE PEOPLE AND THEIR ABSORBING AND
REFLECTIVE CAPABILITES TOO
.
Suggested clearance distances between the portable and mobile RF telecommunication devices and the WIWE mobile heart diagnostic device
T
HE
WIWE
MOBILE HEART DIAGNOSTIC DEVICE WAS MADE TO USE IN SUCH ELECTROMAGNETIC ENVIRONMENT
,
WHERE THE
RF
DISTURBANCES ARE UNDER CONTROL
.
T
HE BUYER OR USER OF THE
WIWE
MOBILE HEART DIAGNOSTIC DEVICE CAN HELP TO PREVENT THE ELECTROMAGNETIC DISTURBANCES BY DETERMINING THE SMALLEST CLEARANCE DISTANCE BETWEEN THE TELECOMMUNCATION DEVICES
(
TRANSMITTERS
)
AND THE
WIWE,
DEPENDENT ON THE TELECOMMUNACTION DEVICE
’
S HIGHEST OUTPUT CAPACITY
.
The transmitter
’s
highest given output
capacity
W
Clearance dist
ance based on the transmitter’s frequency
(m
)
150 kHz
–
80 MHz
d=[3,5/V
1
]√P
80 MHz
–
800 MHz
d=[3,5/E
1
]√P
800 MHz
–
2,5 GHz
d=[7/E
1
]√P
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,69
3,69
7,38
100
11,67
11,67
23,33
In case of the transmitter with the highest output capacity that are not in this table the
suggested clearance distance in meters (m) can be determined with the use of the equation dependent on the transmitter’s freq
uency,
where P is the highest ouput transmitting capacity given buy the manufacturer in Watts (W).
1.
N
OTE
: In case of 80 MHz and 800 MHz the higher frequency interval (upper) needs to be used
2. N
OTE
:
These are only guidelines. It is possible, that el
ectromagnetic spreading can’t be used in every situation, it is dependent on the objects in the environment, the spatial loca
tion of the people and their absorbing and
reflective capabilites too.
