ev3 ARTISSE ISD-5 Mode D'emploi page 6

WARRANTY DISCLAIMER
Although this product has been manufactured under carefully
controlled conditions, the manufacturer has no control over the
conditions under which this product is used. The manufacturer
therefore disclaims all warranties, both expressed and implied, with
respect to the product including, but not limited to, any implied
warranty of merchantability or fitness for a particular purpose.
The manufacturer shall not be liable to any person or entity for
any medical expenses or any direct, incidental or consequential
damages caused by any use, defect, failure or malfunction of the
product, whether a claim for such damages is based upon warranty,
contract, tort or otherwise. No person has any authority to bind
the manufacturer to any representation or warranty with respect
to the product . The exclusions and limitation set out above are
not intended to, and should not be construed so as to contravene
mandatory provisions of applicable law. If any part or term of this
Disclaimer of Warranty is held illegal, unenforceable or in conflict
with applicable law by a court of competent jurisdiction, the validity
of the remaining portions of this Disclaimer of Warranty shall
not be affected, and all rights and obligations shall be construed
and enforced as if this Disclaimer of Warranty did not contain the
particular part or term held to be invalid .
DISPOSAL
Dispose of Artisse™ Detachment Device in accordance with
hospital, administrative and/or local government policy.
Declaration about the Electromagnetic Compatibility of
Artisse™ Detachment Device according to EN60601-1-2 Ed: 4.0
Electromagnetic Emission
The Artisse™ Detachment Device is intended to be used in the
electromagnetic environment specified below. The customer
or user of the device should ensure that it is used in such an
environment .
Emissions Test Compliance
RF-Emissions
Group 1
CISPR 11
RF-Emissions
Class [A]
CISPR 11
Harmonic
Not
emissions IEC
applicable
61000-3-2
Voltage
fluctuations/
Not
flicker
applicable
emissions
IEC 61000-3-3
Electromagnetic
Environment Guidance
The device uses RF Energy
only for its internal function.
Therefore the RF Emission is
very low and it is more unlikely
that nearby equipment is
affected.
The Artisse™ Detachment
Device is suitable for use in
all establishments other than
domestic and those directly
connected to the public low-
voltage power supply network
that supplies buildings used
for domestic purposes .
Electromagnetic Immunity
The Artisse™ detachment Device is intended to be used in the
Electromagnetic environment specified below.
The customer or user of the device should ensure that it is used in
such an environment .
Immunity IEC 60601
Test test level
± 8kV
ESD 61000-
Contact
4-2
±15kV Air
±2 kV for
power
Electrical
supply
fast
lines
transient/
±1 kV for
burst IEC
input/
61000-4-4
output
lines
±1 kV
line(s) to
Surge IEC line(s)
61000-4-5 ±2 kV
line(s) to
earth
<5 % UT
(>95 % dip
in UT)
for 0,5
Voltage
cycle
dips, short
40 % UT
interruptions
(60 % dip in
and
UT)
voltage
for 5 cycles
variations
70 % UT
on power
(30 % dip in
supply
UT)
input lines
for 25
IEC 61000-
cycles
4-11
<5 % UT
(>95 % dip
in UT for
5 s)
Power
Frequency
50/60Hz
3 A/m
magnetic
field IEC
61000-4-8
4
Electromagnetic
Compliance
Environment
level
Guidance
Floors should be
wood, concrete
or
±2/4/6/8 kV Ceramic tile . If
Contact floors are covered
±2/4/8/15 with synthetic
kV Air material, the
relative humidity
should be at least
30 %.
Not
Not Applicable
Applicable
Not
Not Applicable
Applicable
Not
Not Applicable
Applicable
Power frequency
magnetic fields
should be
at levels
characteristic of
30 A/m
a typical location
in a typical
commercial
or hospital
environment .