Air Techniques Rxonly ProVecta 3D Prime, Operating Instructions Manual

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2 Safety
The unit has been developed and designed
appropriately such that hazards are largely
excluded if the unit is used in accordance with its
Normal Use.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects to skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended use and indication
ProVecta 3D Prime is computed tomography x-
ray unit intended to generate 3D and panoramic
X-ray images in dental radiography for adult and
pediatric patients. It provides diagnostic details of
the maxillofacial areas for a dental treatment.
The device is operated and used by physicians,
dentists, and x-ray technicians.
Not intended for mammography use.
2.2 Normal use
The unit must only be used by dentists or dental
assistants who have been trained in the use of X-
ray radiation in accordance with the applicable
legal requirements.
2.3 Improper use
Any use of this appliance/these appliances above
and beyond that described in the Installation and
Operating Instructions is deemed to be incorrect
usage. The manufacturer cannot be held liable
for any damage resulting from incorrect usage.
The operator will be held liable and bears all
risks.
2.4 Contraindication
The radiobiological effects of X-ray beams in tis-
sue result in the following contraindications:
– Pregnancy
– Pre-existing illnesses preventing the recording
of a CBCT image
– Absence of a justified indication
Exceptions can be formulated at the discretion of
the physician.
2.5 General safety information
❯
Comply with the guidelines, laws, rules and
regulations applicable at the site of operation
when you use this unit.
❯
Prior to each use, check the function and
proper condition of the device.
❯
Do not convert or modify the unit.
❯
Comply with the Installation and Operating
Instructions.
❯
Make the Installation and Operating Instruc-
tions always available to the operator in the
vicinity of the device.
The sale or prescription of this device by a medi-
cal practitioner is subject to the restrictions of the
applicable Federal Acts. The device may be used
only under permanent supervision by a dentist or
licensed medical practitioner.
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 reg-
ulations and X-ray protection measures.
❯
Use the prescribed X-ray protection equip-
ment.
❯
In order to reduce the level of X-ray exposure,
we recommend the use of bismuth, lead
shielding or protective aprons, especially for
children and teenagers.
❯
The persons operating the equipment must
keep away from the X-ray unit while the expo-
sure is being taken. The minimum distance
required by the law must be maintained.
❯
Children and pregnant women must consult a
doctor before recording an X-ray image.
❯
No person other than the patient is permitted
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 prevent
entry by unauthorized persons.
❯
If a fault occurs, abort the exposure immedi-
ately by releasing the trigger button.
Important information
2210200496L41 1911V006 5
EN-
US