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Medfusion® Model 3500 pump V6
Operator’s Manual
Guidance and manufacturer’s declaration – electromagnetic immunity
The Medfusion® Syringe Pump Model 3500 V6 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Medfusion® Syringe Pump Model 3500 V6 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
outside ISM bands
a
10 Vrms
150 kHz to 80 MHz in
ISM bands
a
10 V/m
80 MHz to 2.5 GHz
3 V
10 V
10 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the Medfusion® Syringe Pump
Model 3500 V6, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2
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
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:
î
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
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 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 Medfusion® Syringe Pump Model 3500 V6 is
used exceeds the applicable RF compliance level above, the Medfusion® Syringe Infusion Pump Model 3500 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Medfusion® Syringe Pump Model 3500 V6.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Summary of Contents for Medfusion 3500
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