13
Guidance and Manufacturer
’
s Declaration
–
Electromagnetic Immunity for all Equipment and Systems
Adherus AutoSpray ET Dural Sealant is a battery operated system and is intended for use in the electromagnetic
environment specified below. The customer or user of Adherus AutoSpray ET Dural Sealant 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
Not Applicable Battery
Operated System with
no Digital Circuitry
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
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
Not Applicable Battery
Operated System
Main 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
Not Applicable Battery
Operated System
Main 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 cycle
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 sec
Not Applicable Battery
Operated System
Main power quality should be that of a
typical commercial or hospital
environment. If the user of the
equipment requires continued operation
during power main interruptions, it is
recommended that the equipment be
powered from an uninterruptible power
supply or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Not Applicable Battery
Operated System with
no Magnetically
Sensitive Components
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
*NOTE: U
T
is the a.c. main voltage prior to application of the test level.
