48
49
IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and the device, as recommended below, according to the maximum output power of the
communications equipment.
Immunity test: IEC 61000-4-3
CERTIFICATIONS
The company E-Swin SAS, the exclusive manufacturer of
device, is certified to ISO standards 13485.
CONFORMITY
E-SWIN hereby declares that
meets the essential re-
quirements of the 93/42/CEE Directive, Annex II, Article 3, and
holds the CE mark under the responsibility of TUV Rheinland. It
is consistent with the standard : EN 60601.
STANDARDS
LIGHT EMISSION
The
is classified under risk group 3 related to “thermic
retinal” danger.
The inhomogeneity of lighting on the applied surface is below to
20%.
The ocular risk is negligible from a distance, between the eye and
the surface of emission, of 7,40 meters.
Output energy on the treatment area versus user’s
selection:
Energy setting
Fluence (J/cm²)
1
9,0
2
9,8
3
10,6
4
11,4
5
12,2
6
13,0
PRECAUTIONS FOR USE
Never bring the base unit or the applicator into contact with
water. Do not open the base unit or the applicator, as you may
risk exposure to high voltages. Never use cartridges and acces
-
sories other than those designated and sold by E-Swin SAS for
use with
.
ENVIRONMENTAL PROTECTION
You must abide by local regulations for the disposal of packa-
ging and consumables. Insofar as possible, recycling should be
encouraged.
TECHNICAL CHARACTERISTICS
Test frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
Maximum
power (W)
Distance
(m)
IMMUNITY TEST
LEVEL (V/m)
385
380 –390
TETRA 400
Pulse modulation
b)
18 Hz
1,8
0,3
27
450
430 – 470
GMRS 460, FRS 460
FM
c)
± 5 kHz deviation
1 kHz sine
2
0,3
28
710
704 – 787
LTE Band 13, 17
Pulse modulation
b)
217 Hz
0,2
0,3
9
745
780
810
800 – 960
GSM 800/900; TETRA 800;
iDEN 820; CDMA 850;
LTE Band 5
Pulse
modulation
b)
18 Hz
2
0,3
28
870
930
1 720
1 700 – 1990
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation
b)
217 Hz
2
0,3
28
1 845
1 990
2 450
2 400 – 2570
Bluetooth, WLAN, 802.11 b/g/n,
RFID 2450, LTE Band 7
Pulse
modulation
b)
217 Hz
2
0,3
28
5 240
5 100 – 5 800
WLAN 802 .11 a/n
Pulse modulation
b)
217 Hz
0,2
0,3
9
5 500
5 785
NOTE:
If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM
may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would
be worst case.