Guidance And Manufacturer's Declaration - Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Tyco Healthcare AutoSonix Manual Del Operador

Guidance and manufacturer's declaration – electromagnetic emissions
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical System should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical System should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
Compliance
The AutoSonix™ Ultrasonic Surgical System uses RF energy only for its internal
Group 1 function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
The AutoSonix™ Ultrasonic Surgical System is suitable for use in all establishments
Class A
other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Complies
IEC 60601
test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
<5 % U
T
(>95 % dip in U ) for 0,5 cycle
T
40 % U
T
(60 % dip in U ) for 5 cycles
T
70 % U
T
(30 % dip in U ) for 25 cycles
T
<5 % U
T
(>95 % dip in U ) for 5 sec
T
3 A/m
Electromagnetic environment – guidance
Compliance level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
<5 % U
T
(>95 % dip in U ) for 0,5 cycle
T
40 % U
T
(60 % dip in U ) for 5 cycles
T
70 % U
T
(30 % dip in U ) for 25 cycles
T
<5 % U
T
(>95 % dip in U ) for 5 sec
T
3 A/m
3
(Table 201)
(Table 202)
Electromagnetic 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.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the AutoSonix™ Ultrasonic
Surgical System requires continued
operation during power mains
interruptions, it is recommended
that the AutoSonix™ Ultrasonic
Surgical System be powered from
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.