ASTOPAD
®
Instructions for Use
17 Guidelines and manufacturer’s declaration
64
Guidelines and manufacturer's declaration - electromagnetic immunity
ASTOPAD is intended for use in the electromagnetic environment specified below. The customer or user of ASTOPAD
should assure that the system is used in such an environment.
Immunity test
Test level
Compliance
level
Electromagnetic environment
– recom-
mended separation distance
Conducted disturb-
ances induced by
high-frequency
fields according to
IEC/EN 61000-4-6
3 V
eff
0.15 MHz to 80 MHz
6 V
eff
in ISM frequency
bands between 0.15
MHz and 80 MHz
80 % AM at 1 kHz
Complies
P
d
2
,
1
Radiated RF dis-
turbances
IEC 61000-4-3
3 V/m / 10 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
Complies
P
d
2
,
1
80 MHz to 800 MHz
P
d
3
,
2
800 MHz to 2.7 GHz
Portable and mobile RF communication equipment should not be used at a distance from ASTOPAD (including its ca-
bles) that is less than the recommended separation distance calculated from the equation applicable to the frequency of
transmission.
Where P is the maximum output power rating of the transmitter in watts (W) as specified by the transmitter manufacturer
and
d
is the recommended separation distance in meters (m).
At all frequencies according to an on-site test
a
, the field strength of fixed RF transmitters is lower than the compliance
level
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher value applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic wave propagation is affected by absorption
and reflection from structures, objects and people.
a
The field strength of fixed transmitters, e.g. base stations of mobile phones and land mobile services, amateur radio
stations AM and FM radio and television transmitters, cannot be theoretically determined precisely beforehand. To as-
sess the electromagnetic environment due to fixed RF transmitters, a site survey is recommended. If the measured field
strength at the location in which the ASTOPAD is used exceeds the compliance level specified above, the ASTOPAD
should be observed to verify normal operation at that application site. If abnormal performance is observed, additional
measures may be necessary, such as reorientation or relocation of the ASTOPAD.
b
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and ASTO-
PAD
ASTOPAD is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or user of ASTOPAD can help prevent electromagnetic interference by maintaining a minimum distance be-
tween portable and mobile RF communications equipment (transmitters) and ASTOPAD as recommended below, ac-
cording to the maximum output power of the communications equipment.
Maximum output power
rating of transmitter in
watts (W)
Separation distance according to frequency of transmitter in meters (m)
150 kHz to 80 MHz
P
d
2
,
1
80 MHz to 800 MHz
P
d
2
,
1
800 MHz to 2.7 GHz
P
d
3
,
2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters whose maximum output power rating is not specified in the above table, the distance can be determined
using the equation applicable to the respective column, where P is the maximum output power rating of the transmitter in
Watts (W) as specified by the transmitter manufacturer.
NOTE 1: For the calculation of the recommended separation distance from the transmitters in the frequency range of
80 MHz to 2.7 GHz, an additional factor of 10/3 was used to reduce the likelihood of interference occurring due to a mo-
bile/portable communication device used unintentionally in the patient area.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic wave propagation is affected by absorption
and reflection from structures, objects and people.