WARNINGS
12.1 FEDERAL LAW
The indication below applies to the United States of America only.
The United States Federal Law restricts the use of this medical device in its territory to qualied dental health
professionals, t and certied to perform and manage their professional duties.
For the U.S. market: federal laws restrict these devices to sale by or on the order of a specialized surgeons,
dentists and authorized personnel, who meet the requirements provided by the national laws in force in the
country of installation.
12.2 WARNING APPLICABLE TO ALL COUNTRIES IN WHICH THE DEVICE IS SOLD
The information below is based on the requirements of standards to which the manufacturers of medical devices
must adhere (as stated in the standard IEC 62366).
12.3 USER POPULATION
This radiological medical device must only be used by qualied dental health practitioners, t and certied to
perform their professional duties. The user must be authorised and duly trained (see Section 4.4 Specic user
training), according to the requirements provided by the national laws in force in the country of installation. The
training and preparation of personnel are included in the tasks of RESPONSIBLE ORGANIZATION.
Users must know and comply with the rules of dental practice in compliance with knowledge acquired in the eld
and the key medical hygiene principles including cleaning, disinfection and sterilization of medical devices.
The medical device can be used by any adult dental practitioner of any weight, height, gender and nationality.
The user must wear gloves.
The user is not the patient.
The user must not be prone to any of the following:
• visual impairments: any vision problems must be corrected by glasses or lenses.
• hearing diculties that could prevent the user hearing audible alarms depending on medical devices;
• diculty memorizing or concentrating that could affect the setting of sequences or the performance of
acquisition protocols.
12.4 SPECIFIC USER TRAINING
THE INDICATION BELOW APPLIES TO THE ONTARIO ONLY:
The Standard of practice for CT dental scanners approved by Council – April 18, 2011 prescribes specic
professional requirements for the use of CT dental scanners with respect to the FOV generated
INFORMATION APPLICABLE TO ALL THE COUNTRIES WHERE THE DEVICE IS SOLD:
ACTEON Imaging, upon request, provides Training and/or materials for training on the basis of the specic needs
identied by RESPONSIBLE ORGANIZATION.
Contents, duration, options and details of the training courses are detailed in the purchasing contract, for
information you must ask to your dealer / distributor.
12.5 PATIENT POPULATION
This medical device is designed to be used with the following patient population:
• Children from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height],
• Teenagers,
• Adults,
• Old Age Pensioners.
This medical device can be used on any patient of any weight, age, height (except the restrictions indicated for
children), gender and nationality.
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