Pioon H1 - Safety Guidelines; Proper Use Instructions

USER MANUAL Page 8 of 69
2 SAFETY
2.1 Proper Use
2.1.1 General
The diode laser in the H1 system is a Class 4 laser system. The user must ensure
that the device works properly and is in a satisfactory condition before each use.
"Proper use" includes following all the instructions for use and ensuring that all
inspections and service tasks are performed.
Apply and meet the underlying guidelines and /or national laws, national regulations
and the rules of technology for medical devices applicable for startup and use of the
PIOON products for the intended purpose.
The user must observe the following:
 only use properly operating equipments;
 protect himself or herself and third parties from danger;
 avoid contamination from the product.
During use, national legal regulations must be observed, in particular:
 the applicable health and safety regulations.
 the applicable accident prevention regulations.
To guarantee constant readiness for use and maintenance of value of the PIOON
product, the recommended servicing and safety inspections must be done annually.
Authorised to repair and service the PIOON product:
 Technicians from the PIOON or its branches who are trained to deal with the
product.
 the technicians of the PIOON franchised dealers specifically trained by PIOON.
The operator, person responsible for the device and user must operate their devices