ZOLL AED 3, Administrator'S Manual

Page: 46 / 72

38 ZOLL AED 3 Administrator’s Guide 9650-000752-01 Rev. D
Immunity
test (cont’d) IEC 60601 test
level (cont’d) Compliance
level (cont’d) Electromagnetic environment
- guidance (cont’d)
Recommended separation
distance
Radiated RF
IEC 61000-4-3 10 V/m
80 MHz to
2.5 GHz
10 V/m
d = 1.20 80 MHz to 800 MHz
d = 2.30  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,
c
should be less than the
compliance level in each
frequency range.
d
Interference may occur in the
vicinity of equipment marked with
the following symbol:
The ZOLL AED 3 defibrillator is suitable for use in all professional and domestic
establishments. It is not intended for use near intentional transmitters of radio energy
outside the ranges stated in the above table, such as high frequency surgical equipment,
radar installations, or radio transmitters. It is also not intended for use in fixed or rotary
wing aircraft. Operation outside of this environment could result in the misinterpretation of
the ECG rhythms or CPR signals, interference to the display or audio messages, or the
inability to provide defibrillation therapy.
NOTE 1: U
T
is the a.c. mains voltage prior to application of the test level.
NOTE 2: At 80 MHz, the higher frequency range applies.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
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.
b
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.
c
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 AED is used exceeds
the applicable RF compliance level above, the ZOLL AED 3 defibrillator should be observed
to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the AED.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

P

P