Osservazioni Importanti; Product Description - Zhermack D2 Manual Del Usuario

contaminato smaltire in accordo alle normative locali vigenti.

8. OSSERVAZIONI IMPORTANTI

Le eventuali informazioni rilasciate in qualunque modo, anche durante le dimostrazioni, non rappresentano deroga
delle istruzioni d'uso. L' o peratore è tenuto a controllare se il prodotto è idoneo all'applicazione prevista. L'Azienda non
potrà essere ritenuta responsabile dei danni, anche di terzi, che siano conseguenza del mancato rispetto delle istruzioni
o dell'inidoneità all'applicazione e, comunque, nei limiti del valore dei prodotti forniti. Segnalare qualsiasi incidente grave
verificatosi in relazione al Dispositivo Medico al fabbricante e all'autorità competente.
Questo simbolo viene utilizzato per identificare un dispositivo medico come definito nel Regolamento UE 2017/745.
EN - Dispenser D2
1. INTENDED USE
1:1 dental material dispenser.

2. PRODUCT DESCRIPTION

The Dispenser D2 is a non-sterile manual device designed to deliver two-component dental materials (e.g. elastomeric
impression materials, dental cements) from a 50 ml cartridge directly inside the patient' s oral cavity or into another device
(e.g. an impression tray).
The Dispenser D2 is reusable.
3. INDICATIONS FOR USE
This device is intended for use by dental sector professionals and for the purposes of dental treatment. The Dispenser D2
is ideal for delivering two-component dental materials packaged in 50 ml cartridges, such as elastomeric impression
materials and dental cements.
4. CONTRAINDICATIONS
There are no known contraindications.
5. SIDE EFFECTS
There are no known side effects.
GENERAL WARNINGS/PRECAUTIONS:
• The product' s instructions for use must be kept for the duration of its use.
• This device should only be used by dental professionals within a professional dental environment (public or pri-
vate health facilities with the necessary legal authorisations).
• To reduce the risk of cross-contamination, always use new, uncontaminated gloves when handling the dispenser.
• The dispenser is NOT supplied sterile. Before using it for the first time, it must be DISASSEMBLED,
CLEANED, DISINFECTED AND STERILISED following the instructions given in sections 6.2.1, 6.2.2,
6.2.3 and 6.2.4.
• Replace the dispenser if it becomes visibly worn or damaged. The end of the reusable dispenser' s life cycle is
normally determined by wear and/or damage resulting from use.
6. STEP-BY-STEP INSTRUCTIONS
6.1 PRELIMINARY OPERATIONS
1. Read the instructions prior to use.
2. Disinfect your hands and put on a new pair of disposable gloves.
6.2 CLEANING, DISINFECTING AND STERILISING THE DEVICE
SPECIFIC WARNINGS/PRECAUTIONS:
• The cartridge and the mixing tip must always be removed from the dispenser before the dispenser is cleaned,
disinfected and sterilised.
INSTRUCTION FOR USE