1.2.1
Eligible Patient Group
This medical device is designed to be used with the following patient groups:
• Children;
• Adolescents;
• Adults;
• Seniors.
1.2.2
Patient Selection Criteria
It is not recommended to use the device in the following cases.
Air-polisher for supra- and subgingival use:
1.
Upper respiratory tract infections,
chronic bronchitis/asthma;
2.
Pregnant and breastfeeding women;
3.
Patients undergoing treatment
(radiotherapy, chemotherapy,
antibiotics);
4.
Acute infectious oral lesions.
It is not recommended to use the powders in the following cases:
1.
Allergy to the aroma of the powder;
2.
Patients on a sodium restricted diet
or who suffer from serious respiratory
problems, such as chronic bronchitis,
asthma, emphysema, etc., unless
1.2.3
Indications for Use
Use of the device is suitable for all eligible patients (see
doctor has prescribed a treatment among those described in the intended use of the device (see
Chapter 1.1.1 on page 2
1.1.2 on page 2
for the function of the air-polisher).
1.2.4
Users
The device must be used exclusively by specialised and properly trained personnel, specifically
the dental surgeon/dentist or dental hygienist, who must be able-bodied, adult, of any weight,
age, height, gender, and nationality.
for the function of the piezoelectric ultrasonic scaler and
INTRODUCTION
This medical device can be used on patients
of any age, weight, height, gender, and
nationality, where applicable.
Piezoelectric ultrasonic scaler:
1.
Patients with active implantable
medical devices (for example:
pacemakers, hearing aids, and/or other
electromagnetic prostheses) without
prior authorisation from their doctor;
2.
Patients with clinical conditions not
suitable for treatment of the sites (for
example: local anaesthesia).
otherwise specified by their doctor.
All air-polishing devices and piezoelectric
ultrasonic scalers are intended for professional
use only. The user is therefore the only person
able to decide if and how to treat their patients.
Chapter 1.2.1 on page 3
) whose
Chapter
3