1 General Information
This product is an active therapeutic device intended for the exclusive
use for diagnoses, treatments and relative procedures of dentistry.
The product must be operated or handled by the qualified dentists or
by dental staffs under the supervision of the dentist.
Such dentists or dental staffs should instruct and/or assist the
patients to approach to and leave from the product.
Patients should not be allowed to operate or handle the product
unless he/she is so instructed.
1-1 Intended Use of the Product
1-2 Compliance with Regulation and Directive
This product complies with MDR (EU) 2017/745 and RoHS Directive
2011/65/EU.
1-3 Declaration of Conformity
We hereby declare that the product listed below complies with the
essential requirements of the MDR (EU) 2017/745 and RoHS Direc-
tive: 2011/65/EU based on category 8 of Annex I.
Product : DENTAL CHAIR (CLASS
Ⅰ
)
Model : CLESTA
Ⅱ
CHAIR / CELEB CHAIR
CLESTA
eⅢ
CHAIR
PROGRES
" CLASS
Ⅰ
" has been defined by the rule 13 of MDR Annex VIII.
The product has been designed and manufactured in accordance with
the European standards as the listed in the Declaration of Conformity.