Pro-Dent CT 161

USER MANUAL
Last update 16.05.2017

PRO-PROJECT
Kwiatowa 43A Street, 22-105 Okszow, Poland
tel.: +48 668 453 266; fax: +48 82 545 24 40

www.pro-project.pl
e-mail: contact@pro-project.pl
 Pro-Dent CT 161

CE – Marking

• This product bears CE-Marking “CE” in accordance with the Council Directive
93/42/EEC about Medical Devices, and fulfils essential requirements of Annex 1 of
the Directive.
The product is a class I device without a measuring function (MDD).

General information

• This user manual is an integral part of the product and should always be kept near the
device. Observance of the manual is a prerequisite for proper performance and correct
operation of the device.
• The warranty period is 5 (five) years and begins on the day of delivery.
It is unaffected by repairs covered by the warranty regulations.
• This technical documentation is in conformity with the device specifications and all
applicable safety standards valid on the day of printing.
All rights are reserved for devices, techniques and names appearing in the manual.

Safety instructions

• Dispose of packaging material according to the applicable waste disposal regulations

and keep it out of the reach of children.
• The product is a medical device. Only a person with sufficient knowledge and skill
may use the device.
• Before using the device, the operator must ascertain that it is in correct working order
and operating condition.
• The operator must be trained in the use of the device.

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Disclaimer
• Operator safety, specific measuring accuracy and interference-free operation can be
guaranteed only if original devices and parts are used. Safe operation and proper
device performance are not guaranteed if accessories or consumables from other
manufacturers are used.
• Pro-Project cannot be held liable for any damage resulting from the use of accessories
or consumables from other manufacturers
• Pro-Project considers itself responsible for safety, reliability and performance of the
device only if assembly, extension, readjustment, modification or repair is carried out
by Pro-Project or by persons/companies authorized by Pro-Project, and only if the
device is used in compliance with the technical documentation.

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Pro-Dent CT 161
Phantom for acceptance and constancy testing of 3D function of dental Cone-Beam CT,
Dental Volume Tomography (DVT) and 3D imaging devices according to DIN 6868-161
and QS-RL.

Technical data (can be modified to customer specifications):

• diameter: 160mm
• 20mm thick main module containing:
– test object containing equivalents of air, soft tissue and bone
– positioning markers
– bubble level
• 20mm, 50mm and 60mm thick PMMA modules with positioning aids
• test stand with a table for placing the phantom in the test position
• folding base for test stand positioning on the X-ray unit’s chair
• convenient, portable case for storing and transporting the phantom

Product features:
• Complies with:
– DIN 6868-161
– QS-RL
• CE certified
• the Manual provides detailed guidelines for carrying out each test, results assessment
and registration

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Procedures for carrying out tests with the Pro-Dent CT 161

For the correct assessment of all desired image quality parameters, some instructions
related to phantom positioning, phantom scanning, and volume data reconstruction need to be
followed:

• The phantom needs to be positioned in the x-ray beam in a way that all the relevant
test structures are captured by the detector. The use of a phantom holder is
recommended.
• It has to be ensured that there are no other objects in the field of measurement than the
investigated phantom. The use of a positioning aid made of very hypodense material
(e.g. polystyrene) might be helpful to isolate the phantom from the peripheral CT x-
ray equipment (see Figure 1 ).
• Cylindrical phantoms have to be in alignment with the z-axis of the CT scanner
• The use of a predefined standard clinical protocol is recommended for volume data
acquisition.
• It has to be ensured that the correct phantom is selected in the evaluation software.
• The volume data reconstruction needs to be performed in a way that the complete
phantom is enclosed
• An appropriate voxel size should be chosen which does not affect the evaluation of
certain image quality parameters (e.g. use a fraction of the expected spatial resolution
when the modulation transfer function shall be calculated).

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Figure 1.Transverse and coronal views of an exemplary volume data set.

The design of the phantom Pro-Dent CT 161 conforming to the German standard DIN 6868-
161 is depicted in Figure 2. It consists of four sections and all image quality parameters
according to are determinable:
• Approximated MTF Assessment of in-plane spatial resolution by using an
approximation procedure.
• Contrast-to-noise indicator (CNI) PVC-PMMA contrast in relation to the noise of the
PVC-PMMA test insert.
• Uniformity indicator (UI*) PVC-PMMA contrast in relation to the maximum
difference between the mean CT value of four peripheral ROIs and the mean CT value
measured for a central ROI.
• Acceptance indicator (AI) CNI weighted by the dose at the axis of rotation and by the
50% value of the approximated MTF.

The specification and the placement of the ROIs used for determining all these image
quality parameters are given in Table 1 and Figure 3.
It should be noted that the dose at the axis of rotation has to be entered as an additional
evaluation parameter when prompted by the application.

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Figure 2: Design of the phantom Pro-Dent CT 161 (a)–(d) Ideal transverse views of section
1–4 (C=0 HU, W=1000 HU).

Table 1: Specification of the evaluation ROIs for the phantom

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Figure 3: Schematic placement of the evaluation ROIs for the Phantom Pro-Dent CT 161
shown for the ideal transverse views of section 1 (a), 2 (b), 3 (c), and 4 (d). Each ROI is
labeled by its individual ID.

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 TEST RESULTS
Pro-Dent CT 161

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