HeartWare Ventricular Assist System Instructions For Use Manual page 40

HeartWare
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The HVAD ® Pump is intended for use in the electromagnetic environments specified below. The customer or the user of the HVAD
Immunity Test IEC 60601 Test Level
Electrostatic ± 6 kV Contact
◗ ◗
Discharge ± 8 kV Air
◗ ◗
IEC 61000- 4-2
Electrical Fast ± 2 kV for Power supply Lines
◗ ◗
Transient/ ± 1 kV for Input/Output Lines
◗ ◗
Burst
IEC 61000-4-4
Surge ± 1 kV Line to line
◗ ◗
IEC 61000-4-5 ± 2 kV Line to earth
◗ ◗
Voltage Dips, < 5% U (>95% dip in U
◗ ◗
T
Short Interrupts, & < 40% U (60% dip in U
◗ ◗
T
Variations on < 70% U (30% dip in U
◗ ◗
T
power Supply < 5% U (>95% dip in U
◗ ◗
T
Lines
IEC 61000-4-11
NOTE: U is the AC mains voltage prior to application of the test level.
T
Immunity Test IEC 60601 Test
Level
Power Frequency 3 A/m
Magnetic Fields
IEC 61000-4-8
Conducted RF 3 Vrms
IEC 61000-4-6 (150 kHz to 80
MHz outside ISM
Radiated RF bands )
a
IEC 61000-4-3
10 Vrms
(150 kHz to 80
MHz inside ISM
bands )
a
10 Vrms
(80 MHz to 2.5
GHz
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 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 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.
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 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 HVAD
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HVAD
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
I
36 HeartWare Ventricular Assist System
®
Compliance Level
± 6 kV Contact
◗ ◗
± 8 kV Air
◗ ◗
± 2 kV for Power supply Lines
◗ ◗
± 1 kV for Input/Output Lines
◗ ◗
± 1 kV Line to line
◗ ◗
± 2 kV Line to earth
◗ ◗
for 0.5 cycles) < 5% U (>95% dip in U
◗ ◗
T T
for 5 cycles) < 40% U (60% dip in U
◗ ◗
T T
for 25 cycles) < 70% U (30% dip in U
◗ ◗
T T
for 5 s) < 5% U (>95% dip in U
◗ ◗
T T
Compliance Guidance
Level
3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the HVAD
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
3 Vrms d=1.2√P (outside ISM bands)
10 Vrms d=1.2√P (within ISM bands)
10 V/m d=1.2√P (80 MHz to 800 MHz)
d=2.3√P (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).
survey, should be less than the compliance level in each frequency range.
c
the following symbol:
® Pump should assure it is used in such an environment.
Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital
environment.
Mains power quality should be that of a typical commercial or hospital
environment.
for 0.5 cycles) Mains power quality should be that of a typical commercial or hospital
T
for 5 cycles) environment. The HVAD
T
for 25 cycles) supply connected.
T
for 5 s)
T
b Field strengths from fixed RF transmitters, as determined by an electromagnetic site
Interference may occur in the vicinity of equipment marked with
d
® Pump is used exceeds the applicable RF compliance level above, the HVAD
Pump.
®
Pump will always have a battery backup power
®
Pump, including cables, than the
®
® Pump should be observed to