8.8
Instructions for Use & Clinical Reference Manual (US)
TABLE 203
Guidance and Manufacturer’s Declaration – Emissions,
Equipment and Systems that are Life-Supporting
The Automated Impella® Controller is intended for use in the electromagnetic environment
specified below. The customer or user of the Automated Impella® Controller should ensure that it is
used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
d = 1.2
√P
800 MHz to 2.5 GHz
Where P is the maximum
power rating in watts and
d is the recommended
separation distance in
meters.
Field strengths from fixed
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.
(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 Automated Impella
®
Controller is used exceeds the applicable RF
compliance level above, the Automated Impella
®
Controller should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Automated Impella
®
Controller.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m
IEC 60601
Test Level
10 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Compliance
Level
10 Vrms
20 V/m
Electromagnetic
Environment –
Guidance
Portable and mobile RF
communications equipment
should be separated from
the Automated Impella®
Controller by no less
than the recommended
separation distances
calculated/listed below:
d = 0.35
√P
d = 0.6
√P
80 to 800 MHz
