Halyard CO LIEF PMG-Basic - Page 38

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Table 8-3 IEC EMC Specications (Immunity)
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The HALYARD* Pain Management System is intended for use in the electromagnetic environment specied below. The customer or the user of the HALYARD* Pain
Management System should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If oors are covered with
synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV dierential mode
±2 kV common mode
±1 kV dierential mode
±2 kV common mode
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input 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
5 seconds
<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 5 seconds
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the HALYARD* Pain Management System requires
continued operation during power mains interruptions, it is recommended
that the HALYARD* Pain Management System be powered from an
uninterruptible power supply or battery.
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of typical
location in a typical commercial or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
rms
3 V/m
Portable and mobile RF communications equipment should be used no closer
to any part of the HALYARD* Pain Management System including cables,
than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
d = [1.17] √P
d = [1.17] √P 80 MHz to 800 MHz
d = [2.33] √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).
Field strengths from xed RF 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 aected by absorption and reection from structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should
be considered. If the measured eld strength in the location in which the HALYARD* Pain Management System or any of its components are used exceeds the applicable RF
compliance level above, the HALYARD* Pain Management System should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating components or the entire HALYARD* Pain Management System.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Avanos Exhibit 2069 Page 38
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089