IEC/EN 60601-1-2 Standard Requirements
219
Haemonetics
®
Cell Saver
®
Elite
®
+ User Manual
P/N 130859-US, Manual Revision: AA
Table 25, Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or
user of the system should ensure that it is used in such an environment.
Immunity Test IEC/EN 60601-1-2 4th
Edition Test Level
Compliance
Level
Electromagnetic Environmental Guidance
Portable and mobile RF communication
equipment should be used no closer to any part
of the system, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC/EN 61000-
4-6
Radiated RF
IEC/EN 61000-
4-3
3Vrms 0.15MHz to
80MHz
6 Vrms in ISM bands
3 V/m
80 MHz to 2.7 GHz
3Vrms
0.15MHz to
80MHz
6 Vrms in
ISM bands
3V/m
80 MHz to
2.7 GHz
Recommended separation distance:
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 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 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 system is used exceeds the applicable RF compliance level above, the system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
d
3.5
V
1
-------
P
=
d
3.5
E
1
-------
P
=
80 MHz to 800 MHz
d
7
E
1
------
P
=
800 MHz to 2.7 GHz
