Cardiac stimulator 4427 Easypace - Instructions for use
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Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycle
70% U
T
(30% dip in U
T
)
for 25 cycle
5% U
T
(>95% dip in U
T
)
for 5 s
Not Applicable
(a)
Mains power quality should be that of a
typical commercial or hospital environment. If
the User of the 4427 Easypace requires
continued operation during power mains
interruptions, it is recommended that the
4427 device be powered from an
uninterruptible power supply (UPS) or a
battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m Not Applicable
(a)
Power frequency magnetic fields shold be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Conduced 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)
Not Applicable
(a)
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,5 GHz
10 V/m
(1)
Portable and mobile RF communications
equipment should be used no closer to any
part of the 4427 device, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Pd 2,1= 80 MHz to 800 MHz
Pd 3,2= 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
recommended separation distance in metres
(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 following symbol:
NOTES:
(a) The 4427 Easypace device is not mains powered but has an internal power source. U
T
is the a.c. mains
voltage prior to application of the test level.
(b) The ISM (industrial, scientific e medical) bands between 150 kHZ e 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 station 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 4427 Easypace is used exceeds the applicable RF compliance level above, the 4427 device should
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