Body Clock iTENS, User Manual

22

Guidance and manufacture’s declaration – electromagnetic immunity 

The iTENS is intended for use in the electromagnetic environment 

specified below. The customer or the user of the iTENS 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

3 Vrms

3 V/m

Portable and mobile RF 

communications equipment 

should be used no closer 

to any part of the iTENS, 

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  80 MHz to 2,5 MHz

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 metres (m). Field 

strengths from fixed RF 

transmitters, as determined 

by an electromagnetic 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 assess 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 iTENS is used exceeds the applicable RF compliance level above, 

the iTENS should be observed to verify normal operation. If abnormal 

performance is observed, additional measures may be necessary, such 

as re-orienting or relocating the iTENS.

b   Over the frequency range 150 kHz to 80 MHz, field strengths should be 

less than 3 V/m.

iTENS - EMC Information continued