Safety Information; Standards And Regulations; Operating Personnel - Dentsply Sirona SiroLaser Blue Instructions For Use Manual

2 Safety information

2.1 Standards and regulations

Qualification/education
Obligation of the user
Unauthorized access
8
2 Safety information
IMPORTANT
Immediately notify the manufacturer and the national competent
authority of any serious incident that has occurred with the product.
2.1 Standards and regulations
For the installation and operation of the SiroLaser Blue, Dentsply Sirona
requires:
● compliance with IEC 60825-1 and its amendments,
● observance of any supplemental national laws and regulations.
Public legal requirements may include special safety regulations
concerning protection against laser radiation. These requirements must
be fulfilled.
The SiroLaser Blue is manufactured in compliance with the provisions
of Medical Device Regulation 2017/745 concerning medical devices.
National directives regarding electrical installations must be observed.
2.2

Operating personnel

The SiroLaser Blue may only be operated by educated and qualified
personnel (dentist, assistent, dental hygienist). The applicable
occupational safety regulations and accident prevention measures, the
current Instructions for Use and national requirements concerning
education must be complied with.
Know-how Know-how and expertise about laser therapy as well as the skilled use
of the laser and the applied indications are required. Please refer to
applicable country-specific requirements.
Experience Dentsply Sirona recommends to gain practical experience in laser
dentistry before first use of the SiroLaser Blue by attending an
appropriate training. Amongst others Dentsply Sirona offers trainings.
Please see the Dentsply Sirona homepage (www.dentsplysirona.com).
Users are obliged to use only faultless materials, to ensure correct
application and to protect themselves, the patient and other persons
against hazards.
In order to prevent false or improper use, the SiroLaser Blue must not
be used by unauthorized persons. Therefore the SiroLaser Blue
equipment must be protected against unauthorized access when not in
use. This can be achieved, for example, by switching the SiroLaser Blue
off after usage so that the electronic access key (pin code) must be
entered before using it again.
WARNING
The SiroLaser Blue may only be used and maintained by thoroughly
trained personnel.
Dentsply Sirona
Instructions for use SiroLaser Blue
65 40 863 D3648
D3648.201.01.07.02 2023-08