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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
150 HVAD® Instructions for Use
Appendix C: EMC Manual Requirements Guidance Document (continued)
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (continued)
Immunity
Test
IEC 60601
Test Level
Compliance
Level Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the HVAD
®
Pump, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted
RF
IEC 61000-4-6
3 Vrms
(150 kHz to
80 MHz outside
ISM bands
a
)
3 Vrms
(outside ISM bands)
10 Vrms (150 kHz to 80
MHz inside ISM bands
a
)
10 Vrms
(within ISM bands)
Radiated RF
IEC 61000-4-3
10 V/m
(80 MHz to 2.5 GHz)
10 V/m
(80 MHz to 800 MHz)
(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).
b
determined by an electromagnetic site
survey,
c
should be less than the compliance
level in each frequency range.
d
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
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