Radiation Protection; Specialist Personnel; Protection From Electric Shock - Air Techniques ProVecta 3D Prime Installation Instructions Manual

Important information
Make the Installation and Operating Instruc-
i
tions always available to the operator in the vi-
cinity of the device
The sale or prescription of this device by a med-
ical practitioner is subject to the restrictions of
the applicable Federal Acts The device may be
used only under permanent supervision by a
EN
dentist or licensed medical practitioner
US
Caution: Federal law restricts this device
to sale by or on the order of a Doctor
2.6 Radiation protection
Comply with all applicable X-ray protection
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regulations and X-ray protection measures
Use the prescribed X-ray protection equip-
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ment
In order to reduce the level of X-ray exposure,
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we recommend the use of bismuth, lead
shielding or protective aprons, especially for
children and teenagers
The persons operating the equipment must
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keep away from the X-ray unit while the expo-
sure is being taken The minimum distance re-
quired by the law must be maintained
Children and pregnant women must consult a
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doctor before recording an X-ray image
No person other than the patient is permitted
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to be present in the radiation room without X-
ray protection measures In exceptional cir-
cumstances another person may be present
to provide assistance, but this must not be a
member of the surgery staff When the expo-
sure is being taken, make sure that you main-
tain visual contact with the patient and the
unit and keep talking to the patient
The radiation room must be lockable to pre-
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vent entry by unauthorized persons
If a fault occurs, abort the exposure immedi-
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ately by releasing the trigger button
2.7 Specialist personnel
Operation
Persons operating the unit must ensure safe
and correct handling based on their training and
knowledge
Instruct or have every user instructed in han-
i
dling the unit
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Installation and repairs
All installation, resetting, alteration, expansion,
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and repair work must be carried out either by
Air Techniques personnel or by a suitably
qualified person approved by Air Techniques
2.8 Protection from electric shock
Comply with all relevant electrical safety regu-
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lations when you work with this unit
Never touch the patient and unshielded plug
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connections of the device at the same time
Replace any damaged cables or plugs imme-
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diately
Comply with the EMC rules concerning
medical devices
The appliance is designed for operation in
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healthcare facilities (in accordance with IEC
60601-1-2) If the appliance is operated in an-
other environment, observe possible effects
on the electromagnetic compatibility
Do not use the device near HF surgical devic-
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es and MRI equipment
Keep a minimum distance of 30 cm between
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the device and other electronical devices
Note that cable lengths and cable extensions
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have effects on electromagnetic compatibility
No maintenance measures are required to
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maintain the basic EMC safety
NOTICE
Negative effects on the EMC due to
non-authorized accessories
Only Air Techniques accessories or
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accessories approved by Air Tech-
niques may be used
If other accessories are used, observe
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any negative consequences to the
function of the appliance
NOTICE
Erroneous operation mode due to
use immediately adjacent to other
devices or with other stacked de-
vices
Do not stack the unit together with
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other devices
If this is unavoidable, note any poten-
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tial impacts on the operation mode
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