ORTHOPANTOMOGRAPH™ OP 3D 3D Constancy Check Procedure 216221 rev.4 0.805.5264 Disclaimer Copyright © 2019 by PaloDEx Group Oy. All rights reserved. ORTHOPANTOMOGRAPH™, OP™ and OP 3D™ are either registered trademarks or trademarks of KaVo Kerr Group Finland in the United States and/or other countries. KaVo™ is either registered trademark or trademark of Kaltenbach & Voigt GmbH in the United States and/or other countries. All other trademarks are property of their respective owners. Documentation, trademark and the software are copyrighted with all rights reserved. Under the copyright laws the documentation may not be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine-readable form in whole or part, without the prior written permission of KaVo Kerr Group Finland. KaVo Kerr Group Finland reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your KaVo Kerr representative for the most current information. The manufacturer has no liability for consequential damage, personal injury, loss, damage or expense directly or indirectly caused by the use of the product. No agent, distributor or other party is authorized to give warranty or other liability on behalf of the manufacturer with respect to its products. Manufacturer: PaloDEx Group Oy Nahkelantie 160 FI-04300 Tuusula FINLAND Tel. +358 10 270 2000 www.kavokerr.com Scope This document instructs the 3D constancy check procedure, how values are interpreted, and gives a short description of each measurement. Following properties of 3D reconstructed volume are evaluated during inspection: - Image noise - Grey value / Low contrast resolution - Uniformity - Artefacts - High contrast spatial resolution This document assumes KaVo Driver 19.3 (IAM 5.22.18241) or newer is installed on the system. Always see latest driver information for possible changes. For detailed description on csv table data output from the automatic 3D QC check (not required for constancy check completion), please refer to Appendix A. The results of the periodical checks below should be recorded, and the check images archived. To do this, it is recommended that a “Constancy Test” “Patient” record is created under which the test images can be recorded. Appendix B contains record sheet templates. NOTICE! The reference levels may change with x-ray unit firmware / driver updates. Upon such updates, new reference levels for measured values for the unit should be established. Always refer to the limiting values that are specified with current 3D QC test. Appendix C contains reference tables for required tests in The State of New Jersey. Required tools: - 3D QC Phantom (215966) - 3D QC Phantom holder (included with the device) Optional tools: - Constancy test phantom and holder (3D Quality Tool Kit) (215966) 1. Automatic 3D QC program: - Image noise Grey values / Low contrast resolution Field uniformity High contrast resolution Artefacts Perform the “3D QC” program as described in the ORTHOPANTOMOGRAPH™ OP 3D User and Installation Manual. Following measurements are checked automatically with the “3D QC”program: - Noise Grey values / Low contrast resolution Field uniformity High contrast resolution If 3D QC test result is “Passed” then above measurements are within manufacturer specified limits. Reference image of a passed 3D QC test and ROI measurements. To check numerical results, open the resulting image in a 3D viewer. The axial slice 140 of the volume contains measurement results and used reference values. Record results to the sheet templates provided in Appendix B. The measurement results are automatically stored in a csv table. Path for this file is typically C:\ProgramData\PaloDEx Group\IDX\Logs\. It is not necessary, but the created .csv file can be copied to be archived as constancy check results or imported to a spreadsheet program to closer examine the measured values. In case of failed QC result, this file can be attached for technical support request. Appendix A has more information on interpreting this file. Description for the measurements: Image noise: Noise is defined as standard deviation of the 3D measurement ROI in the volume. Noise is determined from several materials in the phantom: - PMMA std. dev. - PTFE std. dev. - Air std. dev. Grey values / Low contrast resolution: Grey values of several materials in the reconstructed volume are measured. There must be difference in grey values in different materials to ensure adequate low contrast resolution and consequently to make sure that good tissue/bone separation is achieved in the 3D volume. Following grey values are measured from the volume: - PMMA average value o Corresponds approximately to X-ray absorption of water - PTFE average value - Air average value Field uniformity: Field uniformity measurement calculates max difference in grey values between centre and border regions of the PMMA material in the phantom. High contrast resolution: High contrast resolution is measured, and the result presented as MTF10 – value. MTF (Modulation Transfer Function) is a function of spatial resolution which refers to the smallest line-pair the system can resolve. 2. Artefacts This check is carried out visually. Person with experience on interpreting 3D images should perform the check. Examine the axial slices of 3D QC volume taken in the previous QC steps. Be aware of artefacts which do not originate from the object or from the projection conditions. Please note that there will be some circles drawn in the volume to indicate areas used for 3D QC program result calculations. Requirement for acceptance: Absence of artefacts, except for those that may be expected due to phantom or projection conditions. If the requirement is fulfilled, confirm in the acceptance report by checking “Artefact”. Examples: Acceptable, shadowing may appear around straight horizontal material interfaces. Not acceptable; discontinuity in circular shape due to geometry mismatch between scans with different offset. In similar artefacts are observed, redo 3D geometry calibrations before retrying 3D QC. If problem persists, contact service. 3. High contrast spatial resolution (alternative method) 1. Place the Constancy test phantom and holder onto the 3D QC phantom holder. 2. When running test for the first time on given unit, set the 3D imaging program as follows: Select the third molars from the dental chart o This adjusts the ROI to middle of the phantom o The FOV is set to 9 x 11 Set resolution to High Set mA to 4.00 mA Disable Scout mode 3. Record selected exposure parameters under constancy check sheet in Appendix B “Selected reference values for the constancy check”. Use these parameters in following periodical checks. 4. Open captured volume in the workstation using a 3D viewer. Use axial view to find maximum number of distinguishable line pairs in the axial slice. Requirements: The visually identifiable space resolution must be at least 1LP/mm. Assessment: The structure 12 (1.2 LP/mm) should be represented precisely as dissociated lines. NOTICE! The groups of lines 13 and 14 (1.3 and 1.4 LP/mm, respectively) are generally easily identifiable. Refer also to the image below for line pair identification (please note that numerical index of the line groups do not appear in the image, they are presented here for line group identification): Following image shows visually accepted line pairs: Reference image of a passed 3D high contrast spatial resolution test. Appendix A. 3D QC measurement values and results in the 3D QC CSV table with Driver Update version 19.3 or newer File default location: C:\ProgramData\PaloDEx Group\IDX\Logs\ Naming: <year><month><day>T<time>-<serial number>-<phantom>-3D.csv For example, 20190624T091258-KT1700009-QC2016-3D.csv File structure: Line 1 4 5 7 10 12 13 14 15 31 32 33 39 48 Contents QC calculation date and time Program ID number Unit FOV size Exposure values Unique image identifier Index value for reconstruction type Number of projections expected for current program Actual number of valid projection images. Number smaller than on previous line may indicate problems in system. Measurements from phantom upper areas Measurements from phantom middle areas Measurements from phantom lower areas Listing of acceptance limits Summary of measured acceptance values Appendix B. Constancy check record and one-year monthly follow-up sheets Operator: System: Serial numbers: System: Type of radiation emitter: Number: Selected reference values for the constancy check (FOV, kV, mA): Results of the check: Series Check item Requirements 1 Image noise Local variation of the pixel 3D QC phantom ROI value around an average value measurements. (according to manufacturer's indications) - PMMA std.dev. PTFE std.dev. AIR std.dev. 2 Grey value / Low contrast resolution Grey values for different materials in reconstructed volume within limits. 3D QC phantom ROI measurements. - PMMA average value PTFE average value AIR average value 3 Uniformity Difference in voxel value of similar thickness zones of a sample within limits. 3D QC phantom ROI measurements. - Uniformity 4 Artefacts In accordance with DIN V 6868-161 Visual check of the phantom 5 High contrast spatial resolution ≥ 1 Lp/mm for 10% contrast (with sample in the center of the scan) Phantom test record, visual assessment of the LP phantom in software Name of the inspector Signature Check condition Date Result Noise Year: Allowed deviation 20% PMMA AIR PTFE max std.dev. std.dev. std.dev. Grey values / low contrast resolution Allowed deviation 20% AIR PTFE PMMA average average average value value value Artefacts January February March April May June July August September October November December Year: Uniformity <200 PMMA uniformity measurement values Center January February March April May June July August September October November December Left Right Anterior Posterior High contrast spatial resolution >1 lp/mm lp/mm Appendix C. Manufacturer’s Recommendations for Alternate Dental CBCT QA Program (for The State of New Jersey) Table 3A Computed Tomography QC Requirements Item 1 2 3 Required Test or Procedure Equipment Function “Indicators, Mechanical & other Safety Checks Film Processing QC Testing CT Number for Water Frequency Daily Daily Daily Substitute Test or Procedure 3D constancy check procedure, code 216221 (part of separate QC kit), Section 1: Automatic 3D QC program None, not applicable 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; 3D quality check automatically performs intensity check for water equivalent 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; Quality check program automatically performs field uniformity check 4 Field Uniformity Daily 5 Laser Film Printer QC Low Contrast Resolution Weekly None, not applicable Initial & Annually QC phantom computerized SW test has limits for signal and noise values of PMMA, PTFE and air. This assures tissue separation performance specified by manufacturer (low contrast resolution). 6 7 High Contrast Resolution Initial & Annually Optionally, QA test can be performed using appropriate Low Contrast phantom. Low Contrast phantom is not provided by manufacturer. 3D constancy check procedure, code 216221, Section 3: High contrast spatial resolution Standard Must work properly None, not applicable Pass QC phantom computerized SW test, applicable measurement Minimum PMMA ROI value (acceptance limits shown by the SW) Pass QC phantom computerized SW test, applicable measurements Maximum PMMA Std. Dev Maximum PTFE Std. Dev Maximum AIR Std. Dev (acceptance limits shown by the SW) None, not applicable Option 1: Pass QC phantom computerized SW test Option 2: To be established by Medical Physicist Constancy test phantom MTF10 – value must be at least 1.0 8 Noise Initial & Annually 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; Quality check automatically performs noise check 9 Scan Localization Light Accuracy Initial & Annually Medical Physicist’s QC Survey Medical Physicist’s Quality Assurance Program Review Initial & Annually Initial & Annually OP 3D User & Installation Manual; Patient positioning light adjustment Same as Alternate Dental CBCT Same as Alternate Dental CBCT 10 11 (Visually identifiable spatial resolution must be at least 1.2LP/mm) Pass QC phantom computerized SW test, applicable measurements Maximum PMMA Std. Dev Maximum PTFE Std. Dev Maximum AIR Std. Dev (acceptance limits shown by the SW) Exact alignment to geometry test phantom marks as per procedure NJAC 7:28-22.10 NJAC 7:28-22.4(a)7 Manufacturer’s Recommendations for Alternate Dental CBCT QA Program Table 6 Medical Physicist’s Computed Tomography QC Survey Item 1 2 3 Required Test or Procedure Scan Increment Accuracy Scan Localization Light Accuracy Patient Dose (Multiple Scan Average Dose) MSAD or Computed Tomography 4 Dose Index-CTDI Pre-Patient Collimation Accuracy 5 Contrast Scale 6 CT Number for Water Substitute Test or Procedure None – Not Applicable Standard OP 3D User & Installation Manual; Patient positioning light adjustment OP 3D User & Installation Manual; Imaging program specifications Exact alignment to geometry test phantom marks as per procedure OP 3D User & Installation Manual; Collimator adjustment 3D constancy check procedure, code 216221, Section 1: Automatic 3D QC program Pass computerized collimation test and test as established by the Medical Physicist Pass QC phantom computerized SW test, applicable measurement Minimum PMMA ROI value Minimum PTFE ROI value Maximum AIR ROI value (acceptance limits shown by the SW) 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; 3D quality check automatically performs Pass QC phantom computerized SW test Small FOV Minimum PMMA ROI ≥ 120 None – Not Applicable As established by the Medical Physicist 7 8 Slice Thickness Field Uniformity 9 Low Contrast Resolution 10 11 12 13 14 High Contrast Resolution Noise Scan Protocol Review Review of Facility and Technologists QC Tests Physicist Report and Recommendations intensity check for water equivalent None- Not Applicable 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; Quality check program automatically performs field uniformity check QC phantom computerized SW test has limits for signal and noise values of PMMA, PTFE and air. This assures tissue separation performance specified by manufacturer (low contrast resolution). Optionally, QA test can be performed using appropriate Low Contrast phantom. Low Contrast phantom is not provided by manufacturer. 3D constancy check procedure, code 216221 (part of separate QC kit), Section 3: High contrast spatial resolution None- Not Applicable Pass QC phantom computerized SW test, applicable measurements Maximum PMMA Std. Dev Maximum PTFE Std. Dev Maximum AIR Std. Dev (acceptance limits shown by the SW) Option 1: Pass QC phantom computerized SW test Option 2: To be established by Medical Physicist Constancy test phantom MTF10 – value must be at least 1.0 3D constancy check procedure, code 216221 Section 1: Automatic 3D QC program; Quality check program automatically performs noise check Same as NJAC 22.10(a) Same as NJAC 22.10(a) (Visually identifiable spatial resolution must be at least 1.2LP/mm) Pass QC phantom computerized SW test, applicable measurements Maximum PMMA Std. Dev Maximum PTFE Std. Dev Maximum AIR Std. Dev (acceptance limits shown by the SW) Same as NJAC 22.10(a) Same as NJAC 22.10(a) Same as NJAC 22.10(a) Same as NJAC 22.10(a)