Eid for life-support functions – ZOLL E Series Monitor Defibrillator Rev R User Manual

Page 107

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9650-1210-01 Rev. R

A-9

EID for Life-Support Functions

The life-support functions

a

of the E Series unit are intended for use in the electromagnetic environment specified

below. Ensure that the E Series unit is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment — Guidance

Portable and mobile RF communications equip-
ment should be used no closer to any part of the
E Series unit, including cables, than the recom-
mended separation distance calculated from the
equation applicable to the frequency of the trans-
mitter.

Recommended Separation Distance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to 80 MHz
outside ISM bands

b

10 Vrms
150 kHz to 80 MHz
in ISM bands

b

3 Vrms

10 Vrms

d = 1.2

d = 1.2

Radiated RF
IEC 61000-4-3

10 V/m
80 MHz to 2.5 GHz

10 V/m

d = 1.2

80 MHz to 800 MHz

d = 2.3

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 recom-
mended separation distance in meters (m).

c

Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,

d

should be less than the compliance level in each
frequency range.

e

Interference may occur in the vicinity
of equipment marked with the follow-
ing symbol:

NOTE 1 At 80 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

The life-support functions on the E Series unit are pacing and defibrillation.

b

The ISM (industrial, scientific, and medical) bands between 150 KHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

c

The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range

80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used
in calculating the recommended separation distance for transmitters in these frequency ranges.

d

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 E Series unit is used exceeds the
applicable RF compliance level above, the E Series unit should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the E Series unit.

e

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

P

P

P
P

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