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STANDARDS
CERTIFICATIONS
E-SWIN SAS, the exclusive manufacturer of the device
has
been awarded an ISO 13485 certification.
COMPLIANCE
E-Swin SAS declares that the
complies with the essential
requirements of Directive 93/42/EEC, Annex II, Article 3 and has the
CE mark under the responsibility of the TÜV Rheinland (CE 0197).
This device therefore complies with the related requirements and
standards.
It is consistent with the standard: EN 60601-1, EN 60601-1-2,
EN 60601-1-6.
PRECAUTIONS FOR USE
Never let either the base or the applicator come into contact with
water. Never open the base or the applicator you can be exposed
to high voltage. Never use cartridges and accessories other than
those designated and sold for
and by E-Swin SAS.
ENVIRONMENTAL PROTECTION
Please comply with local regulations when disposing of
packaging and consumables. Wherever possible, try to promote
recycling.
TECHNICAL CHARACTERISTICS
ELECTROMAGNETIC IMMUNITY
NOTE 1:
UT is the a.c mains voltage prior to application of the test level.
NOTE 2:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption an reflection from
structures, objects and peoples.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which
is used exceed the applicable RF compliance level above,
should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
.
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS
EQUIPMENT AND
is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and
, as recommended below, according to the maximum output power of the communications equipment.
Rates max. output power of trans-
mitter - (W)
Separation distance according to frequency of transmitter (m)
150 Hz to 80 MHz (d = 1,2 √P)
80 MHz to 800 MHz (d = 1,2 √P)
800 MHz to 2,5 GHz (d = 2,3 √P)
0,01
0,12
0,12
0,24
0,1
0,37
0,37
0,74
1
1,20
1,20
2,24
10
3,70
3,70
7,40
100
12
12
24
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
b
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