149Appendix
10
9
8
7
6
5
4
3
2
1
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)
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The HVAD
®
or the user of the HVAD
®
Pump should assure it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Guidance
Electrostatic
Discharge
IEC 61000- 4-2
± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
Refer to Section 4.2 for
guidance on minimizing
the impact of ESD.
Electrical Fast
Transient / Burst
IEC 61000-4-4
± 2 kV on Power Supply
Lines
± 1 kV on Input/Output
Lines
± 2 kV on Power Supply Lines
± 1 kV on Input/Output Lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV Differential Mode
± 2 kV Common Mode
± 1 kV Differential Mode
± 2 kV Common Mode
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage Dips,
Short Interrupts &
Variations on power
Supply Lines
IEC 61000-4-11
< 5% U
T
(95% dip in U
T
for
0.5 cycles)
< 40% U
T
(60% dip in U
T
for 5 cycles)
< 70% U
T
(30% dip in U
T
for 25 cycles)
< 5% U
T
(95% dip in U
T
for 0.5
cycles)
< 40% U
T
(60% dip in U
T
for 5
cycles)
< 70% U
T
(30% dip in U
T
for 25
cycles)
Mains power quality
should be that of a
typical commercial or
hospital environment. The
HVAD
®
Pump will always
have a battery back-up
power supply connected.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level
Power Frequency
Magnetic Fields
IEC 61000-4-8
30 A/m 30 A/m Power frequency
at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
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