Mälzer Dental CORSOART A Instrucciones De Uso página 7

Instruction manual CORSOART
Contraindications
The articulator should not be used in patients who have allergic reactions to the material used in the
medical device.
Target Groups
This document is intended for dentists and dental laboratory technicians as users of the articulator,
and for the staff in the dental practice who disinfect and clean the articulator.
Transport and Storage
Information on the Packaging
Note: Please retain the packaging if you wish to ship the device out for service or repair.
The externally printed symbols are for transport and storage and have the following meaning:
Symbol for „Read instructions for use"
SN
Symbol for „Serial Number"
REF
Symbol for „Article Number"
Symbol for „Date of manufacture"
Symbol for „Manufacturer and manufacturer address"
CE mark (Communauté Européenne). A product bearing this mark complies
with the requirements of the relevant EU directive, i.e. the applicable European
standard.
Nameplate
The nameplate is placed on the packaging of the articulator.
CORSOART Articulator A / AC-Line Typ M
®
SN
Mälzer Dental e.K.
Owner: Carsten Althaus
Schlesierweg 27
31515 Wunstorf, GERMANY
REF
Phone: +49 (0) 5033/9630990
Fax: +49 (0) 5033/963099-99
E-Mail: [email protected]
Web: www.maelzer-dental.de
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articulators
®
General intended purpose - proper use
The user must be aware of the functional safety and the proper condition of the device before each use of the device.
The articulator is a medical device according to the applicable national legislation. The articulator is designed so that no
danger to the user and/or patient shall arise.
This product is only designed for use in dental practices. Any other use is not permitted.
Proper use also involves observing all the stipulations in the instructions for use and adhering to the disinfection and cleaning
instructions.
The general guidelines and/or national laws and regulations applicable to medical devices must be applied to the product and
fulfilled in accordance with its intended use.
It is the obligation of the user:
• to only use tools that are not defective.
• to protect the patient and third parties from any hazards.
• to avoid contamination by the product.
During use, national legal regulations are to be followed, and most particularly:
• The applicable health and safety regulations.
• The applicable accident prevention measures.
In Germany, operators, those responsible for devices, and users are obliged to operate their devices in compliance with the
regulations of the German Medical Devices Act (MPG).
The user is responsible for cleaning and disinfecting the articulator.
Intended use
Articulators are devices for simulating the temporomandibular joint movement. For this purpose, plaster models of the dental
arches of the upper and lower jaw are mounted in occlusion in the articulator. Subsequently, the movements of the jaws
with respect to one another can be simulated, which is essential for the preparation of replacement teeth, partial and full
prosthetics, or splints.
Depending on the setting options for the articulator, mastication movements can be precisely simulated to varying extents.
This makes it possible to produce fixed tooth replacements, such as crowns and bridges, or removable tooth replacements,
such as partial prosthetics, full dentures or splints.
The following types of articulator can be distinguished:
• Non-adjustable articulators
• Semi-adjustable articulators
• Fully adjustable articulators
The various models differ with regard to their setting options, whether it be with regard to individual adjustment of the Bennett
angle, the condylar track inclination, the terminal hinge axis, or the incisal guidance. The incisal disc is exchangeable so that
the gliding angle can also be individually adjusted. With lateral movements of the mandible, condylar displacement occurs. A
distinction is made between an immediate side shift and a progressive side shift. [Reitemeier, 2006]
Arcon Articulators
Furthermore, a distinction can also be made between so-called non-arcon and arcon articulators. In the former, the structure
of the device is the reverse of the human jaw (the condyles are mounted in the upper part of the articulator), while in the latter,
the structure corresponds to the human anatomical conditions of the temporomandibular joint. This has no bearing on the
function, however, since the relative movement of the lower jaw to the upper jaw is the same for both technical approaches.
In non-arcon articulators the course of movement in the articulator joint is reversed compared to the natural process so that it
requires some getting used to. [Seeher, 2004]
Intended medical use
The medical device is designed for modelling a patient's real and individual physiological or non-physiological
temporomandibular joint movements, as may be required when implementing splints, mock-ups, functional crowns and
bridges, partial and total prosthetics, and treatments for craniomandibular dysfunction.
Other intended use
Articulator for the two- and three-dimensional simulation of mandibular movement and temporomandibular function.
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