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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 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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Before leaving the surgery, deactivate the main switch of the device.
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The device is not protected against liquid penetration (Class IPX0 – common protection).
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The device 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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The device must be looked after and kept in perfect efficiency.
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The device must never be left unattended when it is on or ready to start, in particular in the presence of minors or
in general persons not authorised for its use.
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The manufacturer declines all responsibility (civil and penal) for any abuse, negligence or improper use of the
device.
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Unauthorised technicians that modify the device replacing parts or components with others different from those
used by the manufacturer assume the same responsibility as the manufacturer.
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Computers, monitors, printers, mice, keyboards and other devices connected to the X-ray device must be in
compliance with the ISO, IEC and EN standards or the respective local regulations.
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The manufacturer is not responsible for problems or malfunctions of parts or components not approved by the
manufacturer and not in compliance with the standards installed by qualified technicians acknowledged by the
manufacturer.
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Do not use electronic devices that do not comply with IEC 60601-1-2:2007 in proximity of life-support equipment
(e.g. pacemakers or heart stimulators) and hearing aids. Before using any electronic device in health facilities,
always check that it is compatible with the other equipment present.
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The X-ray tube contains insulating mineral oil. This oil is potentially hazardous if ingested or if it comes into contact
with the skin or mucous membranes. In the event of a defect or fault, the oil may leak out. Avoid direct contact with
the oil and do not inhale the vapours.
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Do not eat, drink or smoke near the device.
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OPERATOR'S MANUAL
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