dental X dxp DOMINA PLUS B, Руководство оператора

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GENERAL INFORMATION - 1
1.3 Professional user profiles
European regulations on safety and the sterilization process describe the following professional roles:
OPERATOR a person who uses the device for the intended purpose on a daily basis
MAINTENANCE TECHNICIAN a person assigned to the ordinary maintenance of the device on a daily basis
Note: the operator and maintenance technician may also be the same person.
RESPONSIBLE AUTHORITY: an individual (often the employer) or group of people responsible for the use and maintenance
of the device, who ensures that:
• the operator and maintenance technician are adequately trained to use the device in full safety;
• regular training is provided for all personnel regarding the operation and maintenance of the device, including emergency
procedures in the event of emission of toxic, flammable, explosive or pathogenic material into the environment;
• registration documents for attendance of the training are preserved and its full understanding is verified;
• a written, electronic or paper record is kept of the sterilization procedures carried out from the moment the device is
installed.
1.4 Conformity to European Directives
The Domina Plus B sterilizer produced by NSK Dental Italy satisfies the essential requirements of the Directive 93/42/EEC for
medical devices, European Standard EN 13060 and Directive 2014/68/EC for pressure equipment (PED).
This DENTAL X product has been designed and manufactured with high quality materials and parts that can be recycled and
reused.
Separate disposal of electrical and electronic equipment, in accordance with Directive 2012/19/UE (WEEE).
The equipment belongs to Category 8 (medical equipment). In force in the nations of the European Union,
Norway and Switzerland.
CE Mark and Notified Body number. The CE mark indicates that the device satisfies the essential requirements
of the Medical Devices Directive 93/42/EEC.
Notified Body: IMQ S.p.A., Via Quintiliano, 443, 20138 Milan (Italy), Identification N. 0051.
1.5 Warranty
DENTAL X products are guaranteed against manufacturing errors and defective materials. NSK Dental Italy reserves the right
to examine and determine the cause of any problem. The warranty will be void if the product has not been used properly or
for its intended use, if it has been tampered with by unqualified personnel or fitted with non-original NSK Dental Italy parts.
Replacement parts are available for ten years after production of the model has ceased.
Failure to follow the guidelines given below will void the warranty and/or make the device dangerous to operate.
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In the event of faults and/or malfunction, follow the guidelines given in paragraph 6.2 “Warning messages” and paragraph
6.3 “List of alarms”. If the problem persists, do not attempt to operate the device but contact the NSK Dental Italy technical
support.
„ Do not operate the device until the necessary repairs have been made to restore its proper operation.
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Do not attempt to disassemble the device, replace faulty or damaged components and/or have it adjusted or repaired by
personnel without proper training and authorization from NSK Dental Italy.
„ Faulty or damaged components should only be replaced with original NSK Dental Italy parts.