Clic 2008T, Руководство пользователя

Страница: 37 / 40

2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 35
Guidance and manufacturer’s declaration – electromagnetic immunity
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T hemodialysis machine 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 2008T hemodialysis machine, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
If abnormal performance is observed such as
TMP alarms or blood leak alarms, additional
measures may be necessary, such as re-
orienting or relocating the equipment.
Recommended separation distance
Conducted RF
IEC61000-4-6 3 Vrms
150 kHz to 80 MHz 3 Vrms
150 kHz to 80 MHz
1.2

P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz 3 V/m
80 MHz to 2.5 GHz
1.2

P80 MHz to 800 MHz
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 meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.
b
Interference may occur in the
vicinity of High Frequency Surgical
Equipment (such as electrocautery
devices) or other intentional radio
frequency emitting equipment
typically marked with the following
symbol:
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
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
2008T hemodialysis machine is used exceeds the applicable RF compliance level above, the2008T
hemodialysis machine should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the 2008T hemodialysis machine.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.