Guidance And Manufacturer's Declaration; Electromagnetic Emissions; Electromagnetic Immunity - Le Maitre TRIVEX Manuel D'utilisation

R2931 TUV/ EU Power Cord
R2927 China/ AUS Power Cord
TRIVEX SYSTEM DISPOSABLES/ACCESSORIES
REF DESCRIPTION
7205683 Autoclavable Storage and Sterilization Tray
7209513 Illuminator Inflow Tubing
7209514 TRIVEX , 4.5 mm Blade and Tubing
7209515 TRIVEX, 5.5 mm Blade and Tubing
7210115 Replacement Lamp
GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMISSIONS
The LeMaitre Vascular TRIVEX System is intended for use in the electromagnetic environment specified below. The customer or the user of the LeMaitre Vascular TRIVEX System
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 LeMaitre Vascular TRIVEX System is intended for use in the electromagnetic environment specified below. The customer or the user of the LeMaitre Vascular TRIVEX System
Immunity Test
Electrostatic (ESD) Discharge
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: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
should assure that it is used in such an environment.
Compliance Electromagnetic Environment - Guidance
Group 1 The LeMaitre Vascular TRIVEX System uses RF energy only for its internal functions. Therefore, the
RF emissions are very low and are not likely to cause any interference in nearby electronic equip-
ment.
Class A The LeMaitre Vascular TRIVEX System is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power supply network that supplies build-
ings used for domestic purposes
Class A
Complies
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
should assure that it is used in such an environment.
IEC 60601 Test Level Compliance Level
± 6kV contact ± 6kV contact
± 8kV air ± 8kV air
± 2kV for power supply lines ± 2kV for power supply lines
± 1kV for input/output lines ± 1kV for input/output lines
± 1kV differential mode ± 1kV differential mode
± 2kV common mode ± 2kV common mode
<95% dip in UT for 1/2 cycle <95% dip in UT for 1/2 cycle
60% dip in UT for 5 cycles 60% dip in UT for 5 cycles
30% dip in UT for 25 cycles 30% dip in UT for 25 cycles
>95% dip in UT for 5 sec >95% dip in UT for 5 sec
3 A/m 3 A/m
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic tile and 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 LeMaitre Vascular
TRIVEX System requires continued operation during power mains
interruptions, it is recommended that the LeMaitre Vascular
TRIVEX System be powered from an uninterruptible power supply
or a battery.
The power frequency magnetic field should be at levels
characteristic of a typical location in a typical commercial or
hospital environment
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