Safety - GENDEX Oralix AC Manual Del Usuario

6 Safety

In the interest of the safety of patient and user, the following points should be observed:
Electrical Safety
Only qualified service representatives should be authorized to remove the covers, or otherwise obtain
access to the powered circuits.
The equipment should preferably be used in rooms with provisions in compliance with the relevant
national and/or international legislation and recommendations concerning electrical safety in rooms used
for medical purposes, concerning provisions of an additional protective earth (ground) terminal for
equipotent connection.
Always disconnect or switch the equipment off before cleaning or disinfecting
Mechanical Safety
Where complete safeguarding of the equipment is not possible due care must be taken to ensure that no
part of the user's or patient's body or clothing can be trapped or injured by any part of the equipment.
In particular, make sure that fingers are not caught pinched in the articulated arm, when closing it.
Explosion Safety
The equipment is not suitable for use in the presence of flammable gasses or vapors.
Remember that some disinfectants vaporize to form explosive mixtures, and that if such disinfectants are
used the vapor must be allowed to disperse before the equipment is returned to use.
Radiation Safety
Only qualified and authorized personnel may operate this equipment observing all laws and regulations
upon Radiation Protection.
Operators are strongly urged to acquaint themselves with current recommendations of the International
Commission on Radiological Protection.
Full use must be made of all radiation protection features on the equipment and of all radiation protection
devices, accessories and procedure available to protect Patient and Operator from x-ray radiation.
The tubehead contains dielectric mineral oil, which is potentially injurious in case of ingestion or contact
with skin or mucous membrane.
In case of damage, the oil can flow out of the tubehead. In that case, avoid contact with the oil or breathing
any potential vapor. In case of a limited lost of oil, the oil can be wiped out, wearing impermeable gloves.
Mandatory reporting according to the European Directive 93/42 for medical devices
In order to fulfill the obligations foreseen for the CE marking, the user must report to the
Health Authorities in charge any accident involving the medical device and any eventual
alteration in its features or performances, including insufficient user's instructions, which could
cause death, injuries or a health hazard to patient and/or operator. Such reporting must also
be promptly notified to the manufacturer or his agent, in order to permit the fulfillment of the
obligations foreseen in the a.m. European Directive for the manufacturer.
Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER
GENDEX
18 Oralix AC