Chapter 12, Reference Information
215
Haemonetics
®
Cell Saver
®
Elite
®
User Manual
P/N 120745-IE, Manual revision: AA
Table 19, Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Cell Saver Elite system is intended for use in the electromagnetic environment specified below. The
customer or user of the Cell Saver Elite system should ensure that it is used in such an environment.
Immunity Test
IEC/EN 60601
Test Level
Compliance
Level
Electromagnetic Environmental Guidance
Portable and mobile RF communication
equipment should be used no closer to any part
of the Cell Saver Elite system, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC/EN 61000-
4-6
Radiated RF
IEC/EN 61000-
4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3Vrms
3V/m
Where
P
is the maximum output rating of the
transmitter in watts (W) according to the
transmitter manufacturer and
d
is the
recommended separation distance in meters.
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
equipment 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.
NOTE 3: The Elite device was subjected to immunity testing. However, during immunity testing it is not
practicable to test all possible modes and operating conditions. Because of this, all critical functions of
the Elite system are designed with redundant systems to ensure ongoing safe operation of the device in
all anticipated operating environments.
a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio AM and FM broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To asses 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 Cell Saver Elite system is used exceeds the applicable RF compliance level above, the Cell Saver
Elite system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Cell Saver Elite system.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d
1.2 P
=
d
1.2 P
=
80 MHz to 800 MHz
d
2.3 P
=
800 MHz to 2.5 GHz