Cocoon primelase excelence - Page 6

User Manual I Primelase I 10
23. The manufacturer and distributors will only be re-
sponsible for the safety of the product if repairs, modi-
cations and adjustments are carried out by expressly
authorized qualied personnel and if the appliance is
used by qualied personnel and in accordance with the
instructions of use.
24. The appliance should never be used in presence of
gasses or inammable liquids.
25. Only personnel authorized by the manufacturer
may give technical service to the appliance, especially
in the inside of the protection covers. This includes any
kind of adjustment to the power supplies, power stag-
es and control stages, due to the dangerous voltages
inside the equipment.
26. For safety reasons, the mains cable is supplied with
a plug with earth-fault protection connection. Use only
a suitable electric socket connected to earth. Other-
wise damage could be caused to the appliance and
persons. In the event of problems or questions, contact
the High Technology Products, S.L.U. TSS.
27. We recommend an inspection of the inside of the
equipment by High Technology Products, S.L.U. after
12 months. Technical service will be in charge of in-
spect and verify the correct operation of three main cir-
cuits: hydraulic circuit, electric circuit and optic circuit.
28. Only products and liquids specied by the manu-
facturer should be used, otherwise the guarantee will
be cancelled.
Other safety requirements
IMPORTANT: In the event of any doubts regarding
health, pregnancy, lactation, etc., both the person re-
ceiving the treatment and the person performing it must
consult a specialist before the treatment begins.
MDD Regulation
In general terms, the primelase device has been de-
signed and manufactured to include the basic require-
ments in compliance with Annex II of Directive 93/42/
EEC for Health Products and its revised versions in
Directive 2007/47/EEC. PRIMELASE is classied as a
Class IIb electro-medical device, dened as active ther-
apeutic equipment with exchange of energy with the
human body in a hazardous way. PRIMELASE is clas-
sied as a Class I electro-medical device with earth-
fault protection, in accordance with the requirements
established in the harmonized Standard IEC 60601-1
for basic safety for electro-medical devices. PRIME-
LASE incorporates accessories in direct contact with
the patient to carry out their intended functions, which
are classied as Applied Parts Type B in application of
the harmonized Standard IEC 60601-1. CE marking
conrms compliance with the European Directive appli-
cable to the device.
More specically, in accordance with the intended com-
position and operation, the PRIMELASE equipment
is classied as Class IV laser product in compliance
with the Standard IEC 60601-2-22 for laser products
for medical use, with direct reference to Standard IEC
60825-1 for the safety of laser products. All users of
the laser device are recommended to carefully read
this manual and all the technical information provided,
which explain the operation and safe use of the equip-
ment. Furthermore, users of the laser device should be
familiar with the information to be found in the Euro-
pean Standard EN207 which gives recommendations
for protection against laser energy. All users present in
the room in which the laser energy radiation is emitted
should be familiar with the recommendations and dan-
gers described in this manual.
The standards appearing in this user manual are dened
only as a reference. You may contact with the manu-
facturer if additional information is required about the
applicable standards or its current versions.