EN
OPERATOR'S MANUAL
13
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 provided. 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 replace the single-use hygienic protections of the bite piece before positioning a new patient.
The single-use hygienic protections (Cefla code 97901337) must be stored in a dry and clean place without
direct exposure to sunlight or UV rays.
The bite piece and the chinrest can be disinfected by immersing them in a cold sterilizing liquid. For
sterilization of these parts, follow the instructions of the supplier of the sterilizing product.
Cover all the components that will come into contact with the hands of the dental staff with 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 and the touch screen, mouse and keyboard of the
PC.
Prior to positioning patients for any x-ray exposure, always cover the biteblock with a new clean non-sterile
plastic barrier, to avoid cross contamination.
Note to users in Canada: ask your trusted dental material distributor for any plastic barrier that is suitable in
size and is legally marketed in Canada.
According to Health Canada, bite block covers are Class I devices and are distributed by authorized
establishments only, as listed in the MDEL database.
1.8. SAFETY WARNINGS
1.8.1. CONDITIONS OF USE
In order to use the device in safe conditions, refer to the following paragraphs in the manual.
1.8.2. GENERAL SAFETY
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Do not forget to turn off the main switch on the equipment before leaving the surgery.
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The device is not protected against liquid penetration (Class IPX0
–
common protection).
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The equipment is not suitable for use in the presence of a mixture of flammable anaesthetic gas with oxygen or
nitrous oxide.
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Portable telecommunications devices (RF) may interfere with the X-ray device; use in the vicinity of the X-ray
device should therefore be prohibited.
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This equipment must be stored properly so that it is kept in top working order at all times.
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The user must be present at all times when the equipment is turned on or ready for start-up. In particular, never
leave the equipment unattended in the presence of children or other unauthorised personnel in general;
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The Manufacturer shall not be held responsible (under civil and criminal law) for misuse, carelessness or
improper use of the equipment.
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If any person who is not an authorised technician changes the product in any way by replacing parts or
components with other ones not used by the Manufacturer, they shall assume responsibility for the product.
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Any computer, monitor, printer, mouse, keyboard and any other device connected to the X-ray device must be
compliant with ISO, IEC, EN or local standards.
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The Manufacturer is not responsible for problems or malfunction of parts and/or components not approved by
itself, not complying with the regulations and not installed by qualified technical personnel acknowledged by the
Manufacturer.
