15. Self-adhesive electrodes.
The position of the electrodes is shown in the manual of electrode positions.
The electrodes supplied are top quality, pre-gelled and ready for use, they are particularly
suitable for electrostimulation treatments.
They are very flexible making it easy to treat all areas. Remove the protective plastic from the
electrode before use, position it on the skin as shown in the manual and replace the plastic
after use.
Electrode duration is determined by the skin's pH value; we recommend no more than 20
applications using the same electrode.
Repeated use of the same electrodes can compromise stimulation safety: do not use
electrodes when they no longer stick to the skin; in fact it can cause skin redness that can last
for many hours after stimulation. Consult a doctor if this occurs.
16. Declaration of Conformity
IACER S.r.l., headquartered in Italy, via S. Pertini 24/A 30030 Martellago (VE), declares on its
own responsibility devices T-ONE EVO I and T-ONE EVO II is manufactured in conformity with
93/42/EEC Directive (MDD) as amended by 2007/47/CE date 25 September 2007.
T-ONE EVO I and T-ONE EVO II are Class IIa devices, with reference to 93/42/EEC Directive
(MDD), annex IX rule 9 (and following modifications Dir. 2007/47/CE)
Martellago, 29/03/2010
17. Technical specifications.
Risk class:
IIa in accordance with the 93/42/EEC directive (and following
modifications).
Insulation class:
Internally powered device with type BF applied parts, in accordance with
the EN 60601-1 standard.
Classification:
IP30, based on the penetration of liquids and powder; equipment not
protected.
Housing:
ABS.
Power Supply:
Ni/Mh rechargeable battery 4.8V 1600mAh.
Battery charger:
model XKD-C0300NHS6.0-5W, input 100-240 VAC 50-60Hz, output 6
VDC 300mA
Ave. consumption: 1 W.
Limitations:
equipment not suitable for use in environments with a high concentration
of oxygen and/or flammable liquids and/or flammable gas; do not use with
equipment for electrosurgery or short-wave or microwave therapy.
Operation:
equipment suitable for continuous operation.
Output channel:
4 channels, independent and galvanically isolated.
Output current:
maximum power, peak to peak 218mA, 31 mA max effective per single
channel with load from 200 ohm to 1000Kohm.
Type of impulse:
compensated biphasic square wave.
IACER SRL
Legal representative
Mario Caprara
MNPG05-08 Ed. 12/10/10 Pag. 52