Penta medical i5/i7 manual rev. 1.5, Table 204 – ADLINK Medical-i7 18/21 User Manual

Page 53

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PENTA Medical i5/i7
Manual

Rev. 1.5

Document: Manual_Medical_i7_R1.5.docx

Page 53 of 59 pages

Last change date: 7-Mar-13

11.3.3. Table 204

Guidance and manufacturer´s declaration – electromagnetic immunity – for EQUIPMENT and
SYSTEM that are not LIFE-SUPPORTING (see 6.8.3.201 b))

Guidance and manufacturer´s declaration – electromagnetic immunity

The PENTA is intended for use in the electromagnetic environment specified below. The customer
or the user of the PENTA 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 V

150 kHz to 80 MHz




3 V/m

80 MHz to 2,5 GHz










10 V






10 V/m


Portable and mobile RF communications equipment
should be used no closer to any part of the PENTA,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

P

d

35

,

0

=





P

d

35

,

0

=

80 MHz to 800 MHz

P

d

7

,

0

=

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 metres (m).

b


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 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 PENTA

is used exceeds the applicable RF compliance level above,

the PENTA

should be observed to verify normal operation. If abnormal performance is observed, additional measures may

be necessary, such as reorienting or relocating the PENTA

.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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