EN
OPERATOR'S MANUAL
49
8. PERIODIC CHECKS AND MAINTENANCE
In the interest of safety and health of the patient, the staff or third parties, inspections and maintenance need to be
carried out at set intervals.
Period
Operator
Object
Description
Yearly
Specialised technician of
the dealer that initially
installed the device or
another
technician
authorised
by
the
manufacturer
The X-ray device as a
whole
In order to assure the
operating safety of the
device, it is advisable to
inspect the x-ray device in
all its parts, in order to
prevent or repair any faults
For installations in the U.S.: please refer to the document “Addendum: Inspection and Maintenance”.
8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE
- Acquisition of the Blank image
The acquisition of the Blank image allows to enhance scanning performance. This short procedure is compulsory and
the iRYS software requires it every two weeks. Further information about this procedure can be found in the "Acquisition
Operations" section of the iRYS manual.
-
Quality control by means of a phantom (QA Phantom)
Image resolution (sets of lines/mm)
2.5 lp/mm
Low contrast resolution
At least 2 low contrast points can be distinguished
Artefacts
The image must not feature artefacts such as visible
horizontal lines or halftoning
Frequency of the check
Yearly
Use the optional phantom, available upon request, with the relevant user instructions, or, as an alternative, use a dental
phantom compliant with IEC 61223-3-4:2000 standard.
The quality control consists in performing a normal examination on QA Phantom through an automatic procedure
guided by the iRYS software. This periodic quality control guarantees proper functioning of the device and the validity
of the results obtained.
The control is carried out by a qualified expert or by the dealer who carried out the first installation of the X-ray device,
or by another technician authorised by the Manufacturer.
In order to correctly carry out this procedure, see “Acquisition operations” in the iRYS manual and the technical manual.
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