151Appendix
10
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
Appendix C: EMC Manual Requirements Guidance Document (continued)
a
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
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
which the HVAD
®
Pump is used exceeds the applicable RF compliance level above, the HVAD
®
Pump
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the HVAD
®
Pump.
d
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2:
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.
NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
Recommended separation distances between portable and mobile RF communications
equipment and the HVAD
®
Pump
The HVAD
®
Pump is indicated for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the HVAD
®
Pump can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the HVAD
®
Pump as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz
outside ISM bands
150kHz to 80MHz
within ISM bands
80MHz to
800MHz
800MHz to
2.5GHz
0.01 0.12 0.12 0.12 0.23
0.1 0.38 0.38 0.38 0.73
1 1.2 1.2 1.2 2.3
10 3.8 3.8 3.8 7.3
100 12 12 12 23
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