LB0261 Rev A 01/2018
© Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc.
Page 42
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
The
miraDry System is intended for use in the electromagnetic environment specified below. The
customer or the user of miraDry System should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic
Environment:
Guidance
Electrostatic Discharge
(ESD)
IEC61000-4-2
±6kV contact
±8kV air
±2,4,6kV contact
±2,4,8kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast transient/
burst
IEC61000-4-4
±2kV for power
supply lines
±1kV for input/
output lines
±2kV line to ground
±1kV line to line
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC61000-4-5
±1kV differential
mode
±2kV common
mode
±0.5, 1kV
differential mode
±0.5, 1, 2kV
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
IEC61000-4-11
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of miraDry
System requires
continued operation
during power mains
interruptions, it is
recommended that
miraDry System be
powered from an
uninterruptible
power supply or a
battery.
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
PASS
Power-frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.