Terumo Advanced Perfusion System 1 Operator's Manual page 308

Technical Support
Table 203 – Guidance and manufacturer's declaration – electromagnetic immunity – for LIFE–
SUPPORTING EQUIPMENT and SYSTEMS (see 6.8.3.201 b))
Guidance and manufacturer's declaration – electromagnetic immunity
The Terumo Advanced Perfusion System 1 is intended for use in the electromagnetic environment specified
®
below. The user of the Terumo
®
environment.
Immunity test
IEC 60601 test level
10 Vrms
Conducted RF
IEC 61000-4-6 150 kHz to 80 MHz
in ISM bands
10 V/m
Radiated RF
IEC 61000-4-3 80 MHz to 2,5 GHz
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.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
a
MHz; 13,553 MHz to 13,567 MHz; 29,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
b
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
c
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 Terumo Advanced Perfusion System 1 is used exceeds the applicable RF compliance level above,
®
the Terumo ® Advanced Perfusion System 1 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Terumo Advanced Perfusion System 1.
®
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d
Advanced Perfusion System 1 should assure that it is used in such an
Compliance
Electromagnetic environment – guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part
of the Terumo
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d =1,2
10 Vrms
a
d =1,2
d =2,3
10 V/m
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,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
11-13
® Advanced Perfusion System1,
√
P
√
P
80 MHz to 800 MHz
√
P
800 MHz to 2,5 GHz
d
c