I-Tech I-TECH 10000, Руководство пользователя

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IACER Srl 3 MNPG179
Compliance of the concerned products with the Directive 93/42/EEC has been
assessed and certified by the Notified Body
0476 - Kiwa Cermet Italia S.p.a.
Via di Cadriano 23 – 40057 Cadriano di Granarolo (BO), Italia
Certificate no.: MED24021
following the certification procedure according to Annex II (excluding point 4) of the
Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
Classification
The I-TECH LA8000 e LA10000 has the following classification:
•
class IIb (Directive 93/42/EEC, Annex IX, rule 9, 10 and further
amendments);
•
class I with B type applied part (classification EN 60601-1);
•
class 4 laser (classification EN 60825-1);
•
equipment unsuitable for use in presence of a flammable
anesthetic mixture containing air, oxygen and nitrous oxide;
•
equipment suitable for continuous operation;
•
equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic
Environmental intended use: Ambulatory and in hospital
I-TECH LA8000/10000 is an electro-medical device that delivers treatments
of laser-therapy, with the help of power laser up to 8000mW (10000mW for
the LA10000 model) for the provision of treatment though a specific probe.
I-TECH LA8000/10000 is an active therapeutic device, not invasive, used
especially by physiotherapists, physicians and pain therapists.
The use of I-TECH LA8000/10000 is reserved to those professionals, who can
guarantee thanks to their training a proper and completely safe use of the
device.
MASSIMO MARCON Martellago, 14/09/2018