iHealth BP5, Instruction Manual

Table 3

For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Table 4

For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

18

Guidance and manufacturer’s declaration - electro magnetic immunity

The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specfied below. The cus-

tomer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.

IMMUNITY

test

IEC 60601

test level

Compliance

level

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6 

Radiated RF

IEC 61000-4-3

3 Vrms 150 kHz

to 80 MHz 

3 V/m 80 MHz

to 2.5 GHz

3V

3V/m

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:

d =1.2√ P

d =1.2 √P 80 MHz to 800 MHz

d =2.3 √P 800 MHz to 2.5 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 meters (m). 

Field strengths from fixed 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: 

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.

radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic envi-

ronment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured  field 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, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications 

equipment and the Wireless Blood Pressure Monitor

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

output power of the communications equipment.

Rated maximum output

power of transmitter W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d =1.2 √P

80 MHz to 800 MHz d =1.2 √P

800 MHz to 2,5 GHz d =2.3 √P

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 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 affected by absorption and reflection from struc-

tures, objects and people.