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General Information
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.
The operators who use the sterilizer daily are represented by qualified medical personnel:
• Doctor;
• Dental surgeon;
• Implantologist;
• Hygienist.
• Dental assistant
MAINTAINER: 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.
TECHNICIAN: a person assigned to the extraordinary maintenance of the device. It is the person authorized to
perform all electrical and mechanical interventions, adjustments and repairs.
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;
the operator is adequately trained on hygiene and sterilization practices used in the dental field;
• 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.
Note: Any serious accident occurring with the device must be reported to the Manufacturer and to the competent
authority of the Member State where the accident occurred.
Please report incidents, near misses and product malfunctions to the NSK Dental Italy customer care office at:
servicesterilization@nsk-italy.it.
1.4 Conformity to European Directives
As reported in the declaration of conformity Mod.444-003, drawn up in compliance with Article 19 Annex IV of the
regulation 2017/745/EU, the DXPclave sterilizer manufactured by NSK Dental Italy meets the essential requirements
defined by 2017/745/EU Regulation for medical devices, according to which it is classified in class IIa. It also
complies with the Directives 2014/68/EC for pressure vessels (PED), 2014/30/EU (Directive Electromagnetic
Compatibility) and 2014/35/EU (Directive Low Voltage).
The DXPclave sterilizer also complies with the reference technical standards EN 13060, IEC 61010-1, IEC 61010-2-
40 and IEC 61326-1.
The declaration of conformity is a printed accompanying document in paper format.
This dxp 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/RAEE). The equipment belongs to Category 8 (medical equipment).
CE Mark and Notified Body number. The CE mark indicates that the device satisfies the essential
requirements of the Medical Devices Regulatory (UE) 2017/745.
Notified Body: TÜV SÜD Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München
– Germany., Identification N. 0123.
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