Anthos A5 CONTINENTAL, Руководство оператора

Страница: 5 / 100

A5 - A6 PLUS - L6
EN
5
Equipment OFF. Ukrainian national symbol of conformity.
C(MET)us Quality Mark (USA and CANADA)
Tipping hazard.
Equipment in compliance with essential requirements of
directive 93/42/EU and subsequent changes
(Class IIa Medical Device).
Notified body: IMQ spa. "Refer to the Technical Manual"
It means that for reasons of safety you need to consult
the Technical Manual before using the equipment.
1.2. INTENDED USE
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient chair, dental unit, dental
handpieces, multifunction pedal and operating light.
The dental unit is intended for professional dental treatment, for example to treat oral and dental pathologies of varying degrees of clinical form, stage,
gravity; and to manage and provide support for dental and oral diagnosis, treatments, post-operative controls for oral health, prevention and prophylaxis.
The prevailing medical conditions to be treated with the dental unit belong to the following branches of dentistry and oral health:
• Oral Hygiene;
• Orthodontics;
• Conservative dentistry and Prosthesis;
• Periodontology;
• Endodontics;
• Implants;
• Oral Surgery.
In order to achieve its intended use, the dental unit may support and control the following parts or devices, if supplied:
• Air/water syringe;
• Turbine;
• Micromotor;
• Scaler;
• Ultrasonic surgical equipment;
• Curing Light;
• Intraoral camera;
• Intraoral X-ray sensor;
• Intraoral 3D Scanner;
• Operating Light;
• Suction system;
• Multimedia systems;
• Intraoral X-ray equipment (support only, excluding management)
The dental chair is designed to support and position the patient during dental treatment.
Contraindications
The device is not intended for the following uses and/or applications:
- Use on unintended anatomical areas;
- Use on patients weighing more than the maximum permitted load;
- Use on non-alert or uncooperative patients or patients unable to maintain their position for the duration of the operation;
- Use by an unauthorised dental practitioner;
- Use by an operator not trained on the device.
Characteristics of the dental unit
• The dental units described in this manual are Medical Devices intended for dental treatment.
• The dentist's board may hold up to 6 instruments.
• The assistant’s board can hold 2 suction tubes and 3 instruments.
• This equipment must be used only by adequately trained personnel (dentists and paramedics).
• The device is intended for non-continuous operation with intermittent loads (see the operating times of the individual parts in the dedicated sections).
• The device is classified as pollution degree 2 (under IEC 60601-1).
• Overvoltage category (under IEC 60664-1): II.
(for American and Canadian markets only):
Dental units and relevant accessories are intended for dental treatment and provide the dentist with a user interface allowing to control the
operation of dental chair and all connected instruments. The system supplies air, water, a suction system and electricity to allow the dentist to
intuitively control all the procedures for patient care normally performed in a dental surgery.
Federal law restricts the sale of this equipment to dentists only.