A3 PLUS - A5 - A6 PLUS - L6
SURGICAL SINGLE CART
Age: approximately 4 years and older, according to the physical characteristics described below (height and weight)
Height: from 1 m.
Weight: see "Maximum permissible load on the dental chair" in the DATA SPECIFICATIONS paragraph.
State of health: good general health (physical impairments are allowed provided that the disability does not affect the patient’s ability to cooperate with
the operator).
Nationality: irrelevant.
State of patient: awake and able to cooperate with the operator.
Pregnancy: there are no special indications for pregnant women, the same indications as above apply.
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.
1.2.1. CLASSIFICATION AND REFERENCE STANDARDS
• Classification of MEDICAL DEVICES:
Dental unit classification according to the rules set out in Annex VIII of Reg. (EU) 2017/745: Class IIa.
The CE mark certifies the conformity of the product with the Medical Device Regulation (EU) 2017/745, as described here.
• Classification of ELECTRICAL MEDICAL EQUIPMENT:
Classification of the dental unit in accordance with standard EN 60601-1 on safety of medical equipment: Class I - Type B.
• Reference standards:
the dental units described in this manual are equipment designed in compliance with IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) (Ed.3),
IEC 60601-1:2005 + A1:2012 (Ed. 3.1), IEC 60601-1-6:2010 (Ed.3), IEC 62366:2007 (Ed.1), IEC 80601-2-60:2019 (Ed.2), IEC 60601-1-2:2014 (Ed.4),
IEC 62304:2006 + A1:2015 (Ed.1.1), ISO 6875:2011 (Ed.3), ISO 7494-1:2011 (Ed.2) and EN 1717:2000 (Ed.1) standards on devices for the safety of
the water system (protection unit type AA and AB).
To Next Page
Loading...
