iHealth BP5 Instructions page 20

Table 3
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer's declaration - electro magnetic immunity
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment spec ed below. The cus-
tomer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
IMMUNITY IEC 60601
test test level
Conducted RF 3 Vrms 150 kHz
IEC 61000-4-6 to 80 MHz
Radiated RF 3 V/m 80 MHz
IEC 61000-4-3 to 2.5 GHz
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 a ected by absorption and
re ection from structures, objects and people.
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic envi-
ronment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in
which the wireless blood pressure monitor is used exceeds the applicable RF compliance level above, the wireless blood pressure monitor
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the wireless blood pressure monitor.
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Table 4
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications
The Wireless Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. The customer or the user of the Wireless Blood Pressure Monitor can help prevent electro-
magnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Wireless Blood Pressure Monitor as recommended below, according to the maximum
Rated maximum output
power of transmitter W
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be deter-
mined 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 a ected by absorption and re ection from struc-
tures, objects and people.
18
Compliance
Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment should be used no closer to any part of
the wireless blood pressure monitor, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
3V
d =1.2√ P
d =1.2 √P 80 MHz to 800 MHz
d =2.3 √P 800 MHz to 2.5 GHz
3V/m
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 meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,
should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
equipment and the Wireless Blood Pressure Monitor
output power of the communications equipment.
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz d =1.2 √P
0.01
0.1
1
10
100
80 MHz to 800 MHz d =1.2 √P
0.12
0.38
1.2
3.8
12
800 MHz to 2,5 GHz d =2.3 √P
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23