Myray 708G, Operator'S Manual

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EN OPERATOR'S MANUAL
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1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION
Single-use hygienic protections are the main means of protection against transmission of cross-infections
between patients. In order to prevent transmission of infectious diseases from patient to patient, it is essential
to always use the single-use protections. The single-use protections are classified as Class I medical device
and may not be replaced with others in a lower class.
The single-use protections must be in compliance with the ISO 10993-1 standards on biocompatibility and
approved by the control bodies where required (e.g. FDA, CE).
Always change the disposable protective cover for the bite before using it for a new patient.
The disposable protective covers must be stored in a clean dry place away from direct sunlight and UV rays.
The bite piece and the chinrest can be disinfected by immersing them in a cold sterilising liquid. For
sterilisation of these parts, follow the instructions of the supplier of the sterilising product.
Cover all the components that will come into contact with the hands of the dental staff with disposable single-
use protections, as they might be contaminated by indirect contact with the patient’s mouth. In particular, be
careful how you handle the control console of the device, the mouse and keyboard of the PC.
Prior to positioning patients for any X-ray exposure, always cover the bite block with a new clean non-sterile
plastic barrier, to avoid cross contamination.
Note for users in Canada: ask your trusted dental material distributor for any plastic barrier that is suitable in
size and is marketed in Canada according to the local regulations in force.
According to Health Canada, bite block covers are Class I devices and are distributed by authorised
establishments only, as listed in the MDEL database.