158
For Medical Staff
Table 203 – Guidance and manufacturer’s declaration – electromagnetic immunity – for IEC 60601-1-2:2007 (EN 60601-1-2:2007)
for LIFE-SUPPORTING EQUIPMENT and SYSTEMS (see 5.2.2.2)
Guidance and manufacturer’s declaration – electromagnetic immunity
The TERUFUSION Syringe Pump Type SS3 OTCI is intended for use in the electromagnetic environment specified below.
The customer or the user of the TERUFUSION Syringe Pump Type SS3 OTCI should assure that it is used in such an
environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the TERUFUSION
Syringe Pump Type SS3 OTCI, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
outside ISM bands
a
3 Vrms
Recommended separation distance
d=1.2
√
P
10 Vrms
150 kHz to 80 MHz
in ISM bands
a
10 Vrms
d=1.2
√
P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
d=1.2
√
P 80 MHz to 800 MHz
d=2.3
√
P 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:
Notes
1. At 80 MHz and 800MHz, the higher frequency range applies.
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 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 TERUFUSION Syringe Pump Type SS3 OTCI is used exceeds
the applicable RF compliance level above, the TERUFUSION Syringe Pump Type SS3 OTCI should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the TERUFUSION Syringe Pump Type SS3 OTCI.
d. Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
