FCR 1 Shot Phantom Semi-Annual Report Form - fuji
Contents
1. Checklist Procedure 1 Each clinical site using CR will have an individual set up and configuration Begin by making a list of system components and the functions that should be checked on a monthly basis It is good practice to include the checklist in your monthly QC records 2 Verify that each function is working and note that the function has been checked If any equipment does not perform as expected contact the appropriate service organi zation to investigate the problem Example FCR Reader 1 Erase IP 2 Urgent processing 3 Date Time 4 HIC LP and IDT connections ID Terminal 1 Barcode Reader 2 Options Buttons 3 Service Options 4 Date Time Performance and Corrective Action Each of the items on the CR Reader function checklist should pass or receive a check mark Items not passing the checklist should be reported immediately Malfunctioning equipment should be reported to service engineer for repair or replacement as soon as possible Reference Operations Chapter 2 in the Fuji Operation Manual Reader Specific Information Section II pages A O in the Fuji Medical Systems CR User s Guide Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 3 Clean CR Reader Air Vents and Work Area Objective It is good practice to keep the intake air vents of the CR Reader hardcopy device and workstations free from lint and other obstructions to reduce dust artifact and ensure proper cooling and oper2. IMAGE NOISE AND ARTIFACT Action Limit Noise similar to baseline image Artifact free Noise Artifact FCR QA workstation Acceptable QA Workstation Acceptable Other workstation Acceptable Other Workstation Acceptable Image Printer Acceptable Image Printer Acceptable Notes Corrective Action Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 39 FCR 1 Shot Phantom Semi Annual Report Form Date Operator Perform the Standard Monthly Tests Plus PRIMARY ERASURE TEST Action Limits No evidence of previous image on returned imaging plate Evidence of previous image Yes No Acceptable Notes Corrective Action ACCURACY OF MEASUREMENT TOOLS Action Limits No more than 5 error 9 5 10 5 cm on 10 cm measurement 19 21 cm on a 20 cm Measurement QA Workstation Accuracy Acceptable Diagnostic Workstation Accuracy Acceptable Image Printer Scale Accuracy Acceptable Notes Corrective Action EXPOSURE LINEARITY TEST Action Limits S of image 1 should be double 15 that of image 2 S of image 3 should be one half 15 that of image 2 Optical density of center measure ment circle EC of images 1 and 3 should be within 15 of image 2 see example in test instruction section Image 1 S Image 2 Ss Image 3 S Image 1 OD Image 2 OD Image 3 OD Notes Corrective Action Acceptable Acceptable Acceptable Acceptable Acceptable Accep
3. FUJIFILM Medical Systems U S A Copyright 2000 3 5 Review S Number and L Values ost vw ase TA PE Ner eed Se 27 6 Inspection and Cleaning of Imaging Plates 221121 1 28 29 7 Inspection and Cleaning of Cassettes 2 0 0 eee ee eee 30 8 Check CR Reader Functions 646 224 0e rl pee ee Deedee bas ye aie aula 31 9 Clean CR Reader Air Vents and Work Area 0 0 00 eee 32 10 Workstation Monitor Check o og de sody w x x RERO EE 33 IE Repeat Reject Analy SiS V ouod dzia fl or e onse v org ats 34 12 Image Consultation Training uices ieee ses eee eee ese dita 35 13 Preventative Maintenance of CR Reader auaaaaa aaa 11 36 SECTION III Quality Assurance Documentation Forms 1 FCR 1 Shot Phantom Monthly Report Form uaaaaaaaaaaaa1 39 2 FCR 1 Shot Phantom Semi annual Report Form 0 40 3 mage Review L g Sheet vos Ver ENS RE RRXES RUE RD R G 41 4 AP Mamienanec DOS svo sae 3 o reme re o eme e Pe medo 42 5 Workstation Monitor Checklist suas 0 eee eens 43 6 Repeat Reject Analysis Report Form 0 0 00 eee eee 44 4 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Section I FCR 1 Shot Phantom QA Program FCR 1 Shot Phantom Tests and Frequency Name of Test Equipment Relative Sensitivity S Calibration Test Exposure Room CR Image Reader Shading Test CR Image Reader Contrast Evaluation
4. of the original setting Do not change kVp distance or mA settings 3 Expose the phantom wait 10 minutes and process the phantom image as described in the FCR Phantom Exposure Identification and Image Processing Procedures section of the manual 4 Using the Semi annual Report Form record the S number and optical density of the cen ter circle in the lower third of the phantom on the lines designated Image 1 S and OD 5 Using the same IP and cassette repeat steps 3 and 4 except expose the phantom two times before processing and record the S number and optical density measurement on the lines designated Image 2 S and OD 6 Once more using the same IP and cassette repeat steps 3 and 4 except expose the phan tom four times before processing and record the S number and optical density measure ment on the lines designated Image 3 S and OD Precautions Multiple exposures should be conducted at 5 to 10 second intervals between exposures Wait 10 minutes between the final exposure of any series and the processing of the IP Most experts agree that the exposure timer circuit of the generator is more stable than mA station or kVp selection Do not perform this test by changing mA stations If errors are detected it is important to qualify the accuracy and repeatability of the x ray exposure unit System Linearity continued on next page Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 19 Performance an
5. 2 Clean CR cassettes with a cleaning solution typically used for cleaning the exterior of film screen radiographic cassettes Blood or other body fluids should be cleaned with the appropriate germicidal agent Always remove the IP before cleaning the interior surfaces of the cassette DO NOT immerse the cassette when cleaning Apply the cleaning solution to a soft cloth sparingly Always wear the appropriate protective clothing when handling any cleaning solution Allow the cassette to fully air dry before reinserting the IP Performance and Corrective Action Cassettes that exhibit any damage should be removed from use and repaired or replaced Reference IP Handling Appendix B in the Fuji Operation Manual Routine Maintenance page 34 in the Fuji Medical Systems CR User s Guide Cleaning Solution for Imaging Plates ST V HR V Generation and Higher page 35 in the Fuji Medical Systems CR User s Guide CR Imaging Plate and Cassette Warranty Policy page 36 in the Fuji Medical Systems CR User s Guide Fuji Cares About the Environment pages 37 38 in the Fuji Medical Systems CR User s Guide 30 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Check CR Reader Functions Objective It is good practice to confirm that the CR Reader and its attached devices are function ing properly and that indicator lamps operate normally Frequency Monthly or after any service or maintenance on the CR Reader Equipment Needed
6. ambient radiation on IP s it is recommend that they are stored on edge and off the floor Cassettes should be rotated first in first out Only the cassette used for the exposure should be in the x ray room It is poor practice to leave exposed or unexposed cassettes in the x ray room during a procedure Reference Operations Chapter 2 in the Fuji Operation Manual Erasure of IP s page in the Fuji Medical Systems CR User s Guide Technical Tips page 6 in the Fuji Medical Systems CR User s Guide Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 25 Check Image Printer Objective It is good practice to confirm that all printers are producing images of proper density and contrast and are free of artifacts Frequency Daily at the beginning of the workday Equipment Needed Calibration film from integrated printer sensitometer Densitometer internal or external Procedure 1 Review image printers Operation and Service Manual for checking density and calibration procedures 2 Calibrate the printer each time film is loaded or as directed in the manufacturer s manual 3 Verify that fluid levels temperature and chemical activity of wet processing systems are within acceptable limits 4 Inspect images as they are acquired for artifacts If artifacts exist investigate the source and call service as needed 5 If wet processors are used conduct a Hypo Retention test quarterly for film archiva
7. improper positioning or exposure Performance and Corrective Action It is the responsibility of each facility to establish exposure ranges that employ the lowest dose based on image quality desired per examination The cause of abnormally high or low S numbers and L values should be determined and corrective action should be taken to improve these values that effect image quality Reference CR System Speed page 10 in the Fuji Medical Systems CR User s Guide Information on S Numbers pages 11 12 in the Fuji Medical Systems CR User s Guide Acceptable Exposure Range for Fuji CR Imaging Plates pages 13 15 in the Fuji Medical Systems CR User s Guide Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 27 Inspection and Cleaning of the Imaging Plates Objective It is good practice to inspect and clean Imaging Plates on a regular basis to help eliminate unwanted image artifacts Any damage to the IP should be identified and preventative measures put in place to prevent damage to additional imaging plates Frequency Monthly or upon observation of image artifacts Equipment Needed Cleaning solution Lint free cloth Cotton glove Note Lint free cotton gloves and lens cloth are available in most photographic supply stores Procedure 1 While wearing lint free cotton gloves remove the IP from the cassette and inspect for arti facts and physical damage If artifacts exist use a lint free cloth suc
8. the center of the scale and mark the paper at 10 cm intervals using a fine point pencil Compare the distance between the phantom points on the printed CR 1 Shot phantom image and the paper scale produced from that image Performance and Corrective Action Measurement tools on the workstation or printed on the film should be accurate to with in 5 For example a 10 cm measurement on the film or workstation should yield a measured result of 9 5 to 10 5cm or 19 cm to 21 cm over a 20 cm distance Note The scale from the CR Reader may not appear or may be out of the above recom mended tolerances on some brands of printers or network print server systems Scale errors caused by other manufactures devices are beyond our control Check with your printer or network print server manufacturer for additional information 18 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM System Linearity Objective To confirm that the EDR Exposure Data Recognizer will re scale under and over exposure and produce images of consistent density when the phantom is exposed to normal 50 less and 100 more exposure Frequency Semi annually Equipment Needed FCR I Shot CR Phantom Densitometer e Stop Watch e Semi Annual Report Form Procedure 1 Erase the QA designated IP using the secondary erasure mode of your CR image reader 2 Set up the exposure room for your normal phantom exposure except reduce the exposure time to one half 50
9. 53 FUJIFILM I amp 1 Imaging a Information FUJIFILM Medical Systems FCR Quality Assurance Program Introduction This manual consists of three sections Section I describes the Fuji FCR 1 Shot Phantom and the various tests that can be performed using the phantom Section II features good practice tips and maintenance guides for your CR image reader and associated components of your imaging sys tem Section III contains the forms needed to thoroughly document your Quality Assurance Program Do not write in this book photocopy the pertinent forms in Section I Establishing a Baseline Phantom Image and Section III The Fuji FCR 1 Shot Phantom provides a system wide quality analysis by incorporating eight performance tests in a single exposure In addition to a practical analysis of the FCR Reader the test tool provides an image that can be used system wide to evaluate monitor workstation and laser printer performance Consistency in the performance of Quality Control testing is a must We recommend that prior to conducting the monthly phantom exposure hard copy printers are calibrated according to the manufacturers specifications We also recommend that one individual is designated as the Quality Assurance Leader Other individuals should be trained to perform testing in the leader s absence When an error has been detected repeat the test to confirm that the error has not been caused by a procedural mistake It is important to establish th
10. Exposure Room CR Image Reader Workstations Hardcopy Printer Sharpness Test CR Image Reader Workstations Hardcopy Printer Laser Jitter Test CR Image Reader Image Noise Artifact Test Exposure Room Imaging Plate CR Image Reader Workstations Hardcopy Printer Primary Erasure of Imaging Plate Test CR Image Reader Accuracy of Measurement Tools Scale Test Workstations Hardcopy Printer System Linearity Test Exposure Room CR Image Reader FUJIFILM Medical Systems U S A Copyright 2000 Frequency Purpose Monthly Single Exposure Confirms the consistency and calibration of the x ray exposure unit and PMT of the CR image reader Monthly Single Exposure Confirms the uniformity of the CR light guide and optics Monthly Single Exposure Confirms the consistency of the x ray expo sure unit image processing of the CR image reader workstation display and hardcopy printer Monthly Single Exposure Confirms the x ray tubes performance CR Reader optics monitor display and hardcopy printer Monthly Single Exposure Confirms the consistency of the CR Reader laser printer optics and transport systems Monthly Single Exposure Confirms the uniformity of the x ray beam condition of the imaging plates dirt or other foreign matter on the CR Reader light guide monitor degradation and film processor arti fact Semi annually Single Exposure Confirms proper performance of
11. FCR Phantom Exposure Identification and Image Processing Procedures section of this manual 3 After checking the S number to ensure it is in normal range compare the new image against the standard baseline image Performance and Corrective Action Inspect the image for signs of increased graininess or artifact Increased Graininess Increased image grain is typically related to exposure Check exposure factors collimation distance and S number Imaging Plate Dust stains and scratches on the IP will produce white artifacts on the image IP s should be dusted with a soft dry lint free cloth on a monthly basis Particles that cannot be removed in this manner should be removed by gently cleaning the IP with Anhydrous Ethanol CR Reader Reader artifacts can be caused by dust or dirt particles on the Light Guide This will typi cally be demonstrated as a soft edged white line running end to end in the image area of the film parallel to the 14 or 10 dimension Call service to clean the Light Guide Hardcopy Printer Artifacts that are present on the hardcopy but not visible on the QA workstation are usu ally caused by the printer and may require service assistance These artifacts may be caused by laser optics dirty print heads rollers chemical stains or improper film stor age loading or handling Anhydrous Ethanol is a federally controlled HAZMAT and is stocked in most hospital laboratories or pharmaci
12. Medical Systems U S A Copyright 2000 13 Sharpness Objective To confirm optic and image processing systems are functioning normally Frequency Monthly or after service to the CR Reader Equipment Needed FCR QA 1 Shot Phantom image 2X magnifier Monthly Report Form Procedure 1 Use the image produced in the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your CR image reader to produce a new image 2 Expose and process your standard phantom image as described in the FCR Phantom Exposure Identification and Image Processing Procedures section of this manual 3 Inspect the resolution test tool located in the center of the phantom Precautions Be sure to always expose the Fuji FCR 1 Shot Phantom using the small focal spot and at the proper distance Note The copper filter within CR 1 Shot Phantom produces a significant amount of scatter radiation and degrades the visibility of detail in the line pair test tool This evalu ation is a comparative study from month to month and is not meant to demonstrate max imum system resolution System resolution is measured as described in the Acceptance Test Section of the Service Manual of your CR Reader Performance and Corrective Action FCR Readers are available in standard and HQ models Compare the results of your lat est exposure to the standard baseline image Record the results o
13. Monthly Report Form Procedure 1 Use the image produced in the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your CR image reader to produce a new image 2 Expose and process the IP as described in the FCR Phantom Exposure Identification and Image Processing Procedure section of this manual 3 Visually compare the contrast patches against the established baseline Precautions When comparing hard copy images always be sure that the laser printer is freshly cali brated and in control When comparing softcopy images monitor brightness and contrast controls should be checked for display consistency and viewing room lighting set to its minimum level As monitor brightness degrades a loss of visibility of the contrast difference within each patch group will occur It is up to each facility to determine the application and useful life of viewing monitors Note At an 80 kVp non grid exposure it is not uncommon for a slight scatter density pattern to occur in the phantom image around the perimeter of the darkest density patch Performance and Corrective Action The contrast patches should demonstrate two distinct densities each and be similar in relationship to the baseline image Typically a simple pass fail observation is sufficient however measurements on a printed film can be recorded and tracked as a density dif ference Ei FUJIFILM FUJIFILM
14. and Corrective Action Review images on a routine bases for white spots minus density artifacts that may be caused by dust or dirt particles Reference IP Handling Appendix B in the Fuji Operation Manual Routine Maintenance page 34 in the Fuji Medical Systems CR User s Guide Cleaning Solution for Imaging Plates ST V HR V Generation and Higher page 35 in the Fuji Medical Systems CR User s Guide CR Imaging Plate and Cassette Warranty Policy page 36 in the Fuji Medical Systems CR User s Guide Fuji Cares About the Environment pages 37 38 in the Fuji Medical Systems CR User s Guide Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 29 Inspection and Cleaning of Cassettes Objective It is good practice to determine if there is any physical damage to the CR cassette Identify the cause of the problem and remove any damaged cassette from use Insertion of a broken cassette into a CR Reader can result in mechanical failure and system shut down Frequency Monthly or upon observation of a damaged cassette Equipment Needed Soft lint free cloth Mild cleaning solution Procedure 1 Visually inspect the CR cassette The inspection should include the removal of the IP see Inspection and Cleaning of Imaging Plates Any cassette showing physical dam age should be removed from service immediately and repaired If the cassette cannot be repaired to a state that is acceptable for use it should be replaced
15. anual or contact your Fuji Service Engineer or Imaging Specialist for assistance Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 Table of Contents SECTION I FCR 1 Shot Phantom QA Program 1 FCR 1 Shot Phantom Tests and Frequency 0 0 eee eee 6 2 FCR 1 Shot Phantom Diagram 4 4 4226 3 m0 04 s EO ow 0 GR GA Caes 7 3 Establishing a Baseline Phantom Image 0 00 e eee eee 8 4 FCR Phantom Exposure Identification and Image Processing Procedures 9 FCR 1 Shot Phantom Tests 5 Relative S Number Calibration 2 5 6 55 ek EVE xh ERE w 10 11 O Shading CONECUO ca duco espe e doi HEU d Ua Vd ed e dS dors 12 T Contrast Evaluation 22 92 cco eet 4244 enn REPRE REFERO ERE 13 8 Sharpness london es ae ale dA ORG WA eC E Ce eA AG ES SCA S 14 9 EaserJittet ca oma Po BAG Gund WY COSE ZI Se Sek TASSE ad quts 15 10 Image Noise and Artifact oce RE REX VE a E CERE wt 16 11 Primary Erasure F nction iod she oer pet Rr ane Rr 17 12 Accuracy of Measurement Tools 2 05 0 34 i486 ee bee ad eee eee Bat 18 15 System Lineanty ii inc eR ERIS EGW AG izy Bela eee ee 19 20 SECTION II Quality Control and Good Practice Program duo Manes Quality Commitment Program Overview uaaaaaa aaa aaa aaa eee 23 Review Image Quality 5 ua rza SO PRE WPA OR D Ta eaa 24 Erase Unused Imaging Plates ya SUK e nar ERE r 25 Check Image Printer aba wio kei GO E SIL Sea E EID 26 w FUJIFILM
16. ation Frequency Monthly Equipment Needed Soft cloth Mild cleaning solution Vacuum Procedure 1 Use a soft cloth dampened with a mild cleaning solution suitable for plastic and metal surfaces and wipe the surface areas on and around the CR Reader and other components 2 Wipe all work surfaces cassette storage areas and especially the cassette insertion area of the CR Reader Dampen the cloth with the cleaning fluid Never apply solutions directly to any of the components 3 Following the directions on the label an Industrial CRT cleaner can be used for the monitors and IDT s 4 It may be necessary to use a vacuum to remove lint within the vent covers Performance and Corrective Action The possibility of dust artifacts appearing the patient images should be reduced as clean liness is improved Keeping air vents clear and filters clean will ensure proper cooling of the equipment Reference CR Reader Operations and Service Manuals 32 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Workstation Monitor Check Objective It is good practice to assess the general image display of softcopy monitors used for QA or Diagnostic Workstations Frequency Monthly Equipment Needed SMPTE test pattern and or Phantom Image Procedure 1 Clean the monitor with an industrial CRT cleaning solution following the directions on the label 2 Lower the lights in the reading room to their lowest acceptabl
17. d Corrective Action Using the S number and optical density of Image 2 as a baseline compare the images produced at one half and double dose S Number Evaluation As exposure increases S number decreases The S number of Image I should be double 15 that of Image 2 The S number of Image 3 should be one half 24 1596 that of Image 2 Density Evaluation Measure the optical density of the center circle located in the lower third of Image 2 Compare the optical density of the same location of Image 1 and Image 3 The optical density of Images 1 and 3 should be within 15 of Image 2 Example S number of Image 2 186 Target S number for Image 1 is 372 2X Image 2 S number 15 55 8 for an acceptance range of 316 2 to 427 8 Target S number for Image 3 is 93 1 2 Image 2 S number 15 13 95 for an acceptance range of 79 05 to 106 95 Optical density of Image 2 1 45 Target optical density for Image 1 and 3 should be the same 15 0 22 for a range of 1 23 to 1 67 20 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Section II Quality Control and Good Practice Program Quality Commitment Program Overview A complete Quality Assurance Program consists of quality control testing and Good Practice Many important quality control tests are performed with the FCR 1 Shot Phantom However independent testing and maintenance of additional system comp
18. e baseline FCR 1 Shot Phantom image when you are confident that your exposure unit CR image reader workstation and image printing systems are in proper calibration This program was developed by the Imaging Specialist Group at FUJIFILM Medical Systems U S A INC Update and editing was done by Denise M Minnigh and David W MacCutcheon The information contained herein can change without notice owing to product and or technical improvements Please make sure before using the product that the information you are referring to is up to date We assume no responsibility for any consequence resulting from any wrong or improper use or operation etc of the product Copyright 2000 by FUJIFILM Medical Systems U S A INC AII rights reserved Only the Baseline Phantom Image Chart and Quality Assurance Documentation Forms in Section III may be reproduced and copied All other sections of this program may not be reproduced stored in a retrieval system or transmitted in any form or by any means electronic or mechanical including photocopying and recording without written permission from the publisher AII FCR Readers are calibrated to an Sft of 200 when the IP is exposed to an 80kVp beam at a distance of 72 resulting in an exposure of 1mR at the IP surface Fuji does not recommend the use of added filtration in the beam beyond that used in the units normal operation FCR Reader calibration procedures can be reviewed in the Reader Service M
19. e level 3 This test can be performed with the Phantom image and or a SMPTE test pattern While the Contrast Test in this manual can produce a helpful contrast patch pattern it is the product of x ray exposure and therefore not always repeatable Many QA workstations are loaded with the SMPTE test pattern It is good practice to confirm that the 0 5 and the 95 100 patches and horizontal and vertical resolution pat terns are visualized as they were during your baseline evaluation Performance and Corrective Action If there is a detectable change in performance since the baseline evaluation image quality may be compromised A calibration procedure for the monitor may need to be performed by a qualified service person Reference Workstation Monitor Operations and Service Manuals Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 33 Repeat Reject Analysis Objective It is good practice to determine the number and cause of repeated images This data can be used to help reduce patient exposure improve image quality and department efficien cy Employ the same basic procedure as for film screen imaging Frequency Quarterly or as needed Equipment Needed AII reject films images or reject list from Review Image Quality test Total number of films images produced during test period AII repeated images during the analysis period Procedure 1 On a quarterly basis start collecting rejected hardcopy images For
20. e the printer and reprint the image If the S number is in the normal range and printer density is still outside the limits printer service may be needed Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 11 Shading Correction Objective The shading correction of the CR Reader ensures that the scanning laser intensity is uni form across the scanning width of the imaging plate Frequency Monthly and following service to the light guide or optics of the CR Reader Equipment Needed FCR I Shot Phantom image Densitometer Monthly Report Form Procedure 1 Use the image produced in the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your CR Image Reader to produce a new image 2 Expose and process your standard phantom images described in the FCR Phantom Exposure Identification and Image Processing Procedure section of this manual 3 Measure the optical density of the center circle EC located in the lower third of the phantom Record the measured density on the Monthly Report Form 4 Measure the optical density of the circles to the left EL and right ER of center Record the results on the Monthly Report Form Precautions Be sure that the phantom is positioned properly as described in steps 3 and 4 of the FCR Phantom Exposure Identification and Image Processing Procedures The pur pose of these steps are t
21. es If an outside supplier is needed small quantities less than 5 gallons per year can be pur chased from Pharmco Products Inc Phone 203 740 3471 specify Denatured Alcohol SDA3A 200 Proof 16 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Primary Erasure Function Objective To confirm that the primary erase function of the CR Reader is capable of fully erasing an exposed CR imaging plate Frequency Semi Annually following service to the erasure lamp module or when erasure failure is suspected Equipment Needed FCR I Shot Phantom e Semi Annual Report Form Procedure 1 Use the imaging plate returned from the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your CR image reader and produce a new phantom image 2 Expose and process the IP as described in the FCR Phantom Exposure Identification and Image Process Procedures of this manual 3 After the IP is returned to the cassette bring the IP and cassette to the IDT for re pro cessing If you are testing CR Readers with an internal stacker request the return of the same IP using the utility maintenance mode see the specific CR Reader s Operations Manual 4 Reprocess the previously returned IP using the standard Contrast Test menu and verify output image to laser printer and or connected workstation Performance and Corrective Action The image produced
22. ew Image Quality Objective Monitoring image quality and confirming patient identification helps to reduce repeats It is good practice to review the images as they are acquired Frequency Review patient images as they are acquired Equipment Needed Patient images soft and or hardcopy mage Review Log Sheet Procedure Review each patient image and verify that the proper menu was selected 2 Confirm that the correct patient demographics were used 3 Check S number and L values are in the appropriate range for good image quality 4 If contrast or densities are inconsistent validate calibration of the Hardcopy output device 5 Record repeated images on the Repeat Reject Analysis form 6 Report image quality issues such as image noise or a perceivable change in image contrast or density to the person s involved in quality assurance for investigation Performance and Corrective Action Using the acceptable S number and L value range the proper menu selection and patient demographics are important for optimizing patient image quality If repetitive errors are found in these areas additional operator training should be conducted to improve these deficiencies Reference Precautions for Exposure Appendix Z in the Fuji Operations Manual Troubleshooting Guide pages 26 31 in the Fuji Medical Systems CR User s Guide CR System Speed page 10 in the Fuji Medical Systems CR User s G
23. f your evaluation on the Monthly Report Form The resolution target can be viewed on hard copy or on a review station monitor Use a magnifier to help evaluate resolution on a printed film Soft copy presentation may limit the visible resolution of the CR image Use the magnification function on the worksta tion if available Note When reviewing the resolution test tool on soft copy a wavy artifact moir pat tern may occur This is a normal event caused by interference between the frequency of the test tool and display device If your workstation has a magnification tool changing magnification levels will help to reduce or eliminate this interference 14 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Laser Jitter Objective To confirm the mechanical consistency and accuracy of the laser optics module and transport systems of the CR Reader and the laser printer Frequency Monthly after service to the CR Reader Optics or as needed Equipment Needed FCR QA 1 Shot Phantom image 2X magnifier Monthly Report Form Procedure 1 Use the image produced in the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your FCR Image Reader to produce a new image 2 Expose and process the IP as described in the FCR Phantom Exposure Identification and Image Processing Procedures conditions section of this manual 3 Inspect the horiz
24. from the second scanning of the original phantom IP should be completely blank There should be no evidence of residual exposure on the re processed IP If residual image is demonstrated recheck that the original phantom image S num ber is within 200 15 If S number is within normal range and a residual image exists have service check the erasure lamp section of the CR Reader Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 17 Accuracy of Measurement Tools Objective To evaluate workstation and laser printer measurement tool accuracy Frequency Semiannually or following software upgrade to the workstation or printer Equipment Needed Workstation measurement tools if available Printed FCR 1 Shot Phantom image Pencil and paper e Semi Annual Report Form Procedure Workstation If your QA or diagnostic review workstation offers the feature of a measurement tool activate the measurement function Look closely within the object area of the phan tom There are a series of tiny holes drilled at 10 cm intervals in the upper 3 of the phantom Carefully place the cursor over the measurement hole and activate measure ment function Check the tool accuracy at 10 and 20 cm points on the horizontal and vertical axis Printed image Printed images may be presented in reduced or enlarged size If your laser printer produces a measurement scale printed along the outside of the image place a piece of paper in
25. h as a photographic lens cloth and gently rub the surface clean 2 It may be necessary to use a cleaning solution if stains or persistent artifacts remain Use only those cleaning solutions recommended by the IP manufacturer See page 16 titled Image Noise and Artifact Test for more details 3 Always wear appropriate protective clothing when handling cleaning solutions Do not apply the solution directly to the plate rather put a small amount of the solution on a lint free cloth and wipe the surface of the IP in a zigzag pattern to remove the artifact 4 If any artifact cannot be removed by these methods or if physical damage is noted the plate should be immediately removed from service and the Quality Control technologist informed It may be helpful to contact a Fuji Service Engineer to help identify the cause of the damaged imaging plates 5 To ensure the best usage of the IP s within a facility a rotation system for management of cassettes and IP s should be instituted Precautions Using a solution other than those recommended by the IP manufacturer can result in irrepara ble damage and will void any warranty either written or implied Due to the nature of many cleaning solutions it is important to follow the safety recommendations of the solution manufacturer when handling and storing these products Refer to the MSDS sheet for each solution 28 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Performance
26. is essential for maintaining image quality Quality Assurance procedures and good practice methods that uncover a potential problem should be reported to the appropriate service organization for repair or replacement 36 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Section III Quality Assurance Documentation Forms FCR 1 Shot Phantom Monthly Report Form Date Operator RELATIVE SENSITIVITY TEST Action Limit S 20 of baseline Density 0 15 OD baseline Baseline Ss Monthly Test S Acceptable Baseline density Monthly density Acceptable Notes Corrective Action SHADING CORRECTION TEST Action Limit Measured density of outside circles should not exceed 10 of the center circle L Circle C Circle R Circle Acceptable Notes Corrective Action CONTRAST EVALUATION Action Limit Contrast patch visibility compared to baseline image CR QA Workstation Acceptable Other Workstation Acceptable Printed Image Acceptable Notes Corrective Action SHARPNESS TEST Action Limit No change from baseline image Baseline Sharpness monitor Monthly Sharpness monitor Acceptable Baseline Sharpness printer Monthly Sharpness printer Acceptable Notes Corrective Action JITTER TEST Action Limit No Jitter jagged edges visible around T object Jitter on monitor Image yes no Acceptable Jitter on printer Image yes no Acceptable Notes Corrective Action
27. ive S Number Calibration Objective Compare the S number to the standard This test will evaluate the exposure system the calibration of the PMT Photomultiplier tube and the baseline density of hard copy printer devices when an IP is exposed to the pre established dose The image produced from this single exposure will be used for all the phantom evaluation monthly tests Frequency Monthly and following service to the Light Guide or PMT of the CR Reader Equipment Needed FCR QA 1 Shot Phantom Lead Apron Timer Densitometer Monthly Report Form Procedure Note This test should be performed in the confirmed primary x ray exposure room according to the baseline exposure conditions established in the FCR Phantom Exposure Identification and Image Processing Procedure section of the manual Remember the S number is an indication of the amount of exposure reaching the IP the exposure conditions and settings must be identical each month 1 Erase the QA designated IP using the secondary erasure mode of your CR image reader 2 Expose and process the IP as described in the FCR Phantom Exposure Identification and Image Processing Procedure conditions section of this manual 3 Record and evaluate the S number produced on the Monthly Report Form 4 Measure the optical density produced within the center measurement circle EC on the FCR 1 Shot Phantom diagram and record the results on the Monthly Re
28. l Precautions Film is produced in batches Consequently there may be slight variations in the characteris tics of the film between batches In addition film aging and storage conditions can also affect the sensitometric characteristics of the film Calibrate the printer each time film is loaded or as directed in the manufacturer s manual Some printers such as the Fuji Thermal Dry Imager FM DP 2636 and FM DP 3543 require a special optical filter to be installed in X Rite model 301 301RS and 331 densitometers Filter kits are available from FUJIFILM Medical Systems Contact your Fuji Account Manager for information This added filter does not affect density measurements on other film types Check with your printer manufacturer if a compensation filter is needed Performance and Corrective Action If problems are detected corrective action should be taken before clinical films are processed under less than optimal conditions If density steps fall outside control limits fol low the printer manufactures recommendations for proper adjustments or recalibration Reference Image Printer Operations and Service Manuals 26 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Review S Number and L Value Objective To look for trends or exams where exposure factors may need to be optimized It is good practice to review the S numbers and L values as images are acquired and search for trends on a monthly basi
29. m the table and raise it to its maximum height so the beam would strike the floor Turn on the field light Place a lead apron on the floor and in the field Place the designated CR IP and cassette on the apron with the green stripe at the anode end of the x ray tube Place the FCR 1 Shot Phantom directly on the cassette with its identifica tion stripe at the green stripe end Collimate the x ray beam to a size 1 larger than the outside frame of the cassette Set the kVp at 80 and make an exposure on a small mA station 100 mA or less Select a time of 0 10 second Expose and process according to steps 5 12 of the FCR Phantom Exposure Identification and Image Processing Procedures located on the next page If needed first adjust the mA station then the time setting to establish an exposure with an S number close to 200 150 250 Remember as exposure decreases S number increases Record the settings in pencil on the chart below Use the lower box to record the back up exposure room expo sure factors Primary Exposure Room Baseline Exposure Factors Exposure Room Distance IP kVp mA Time Target S Number Phantom Serial CR Reader Back up Exposure Room Baseline Exposure Factors Exposure Room Distance IP kVp mA Time Target S Number Phantom Serial CR Reader 8 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM 10 11 FCR Phantom Exposure Identifica
30. o minimize the heel effect of the x ray tube Prior to servicing the CR Reader check the calibration and shading correction of hard copy devices to eliminate the possibility of a printer problem Some printers such as the Fuji Thermal Dry Imager FM DP 2636 and FM DP 3543 require a special optical filter to be installed in X Rite model densitometers Filter kits are available from FMSU Contact your Fuji Account Manager for information This added filter does not affect density measurements on other film types Check with your printer manufacturer if a compensation filter is needed Performance and Correction Action The measured optical density of either outside circle should not exceed 10 of the center optical density measurement If your measurement exceeds this limit re expose the phantom making sure that the density variation is not caused by beam collimation If the measured result is still out of specification and uniformity of the hard copy printer confirmed call service as needed 12 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Contrast Evaluation Objective To confirm that the contrast of CR image is normal when compared to an established standard This procedure can be performed on printed images the QA workstation and clinical review workstations Frequency Monthly after CR Reader Service or as needed Equipment Needed Baseline FCR QA 1 Shot Phantom image Current FCR QA 1 Shot Phantom image
31. onents such as printers and workstations are also very important This portion of the manual concentrates on quality assur ance aspects that are not a function of the FCR 1 Shot Phantom Good Practice can be defined as a plan for proper usage daily maintenance and housekeeping and should be practiced by all operators A program promoting Good Practice helps to focus all operators into a quality system Section II is designed to be a basic guide for Fuji Computed Radiography systems and the peripheral components that make up the full imaging chain at your facility Consult the manu facturers of the various components involved for their recommendations on quality control rec ommended maintenance schedules and Good Practice This portion of the Quality Commitment program is divided into five timed sequences Every Image Daily Monthly Quarterly and Semi Annual Every Image 1 Review image quality Daily 1 Erase imaging plates 2 Check image printer Monthly 1 Review S numbers and L values 2 Inspection and cleaning of imaging plates 3 Inspection and cleaning cassettes 4 Check CR Reader functions 5 Cleaning of CR Reader air vents and work area 6 Workstation Monitor Check Quarterly Repeat Reject Analysis Semi annual 1 Image Consultation and Training Imaging Specialist 2 Preventative maintenance of CR Reader Service Engineer Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 23 Revi
32. ones Mastoids Sinuses Other CHEST Lungs Ribs Scapula Sternum Other ABDOMEN PELVIS Pelvis Hip Sacrum Coccyx Other UPPER EXTREMITIES Hand Fingers Wrist Forearm Elbow Humerus Shoulder Other LOWER EXTREMITIES Foot Toes Ankle Leg Knee Femur OTHER 44 FUJIFILM Medical Systems U S A Copyright 2000 Ei FUJIFILM Fi FUJIFILM FUJI Medical Systems U S A Inc 419 West Avenue Stamford CT 06902 203 324 2000 www fujimed com
33. ontal and vertical edges of the T object in the phantom image Performance and Corrective Action At the QA workstation inspect the high contrast edges of the T object located in the center of the upper one third of the phantom image Look for jagged edges or loss of continuity If jagged edges exist on the workstation and printed image call for service on the CR Reader If jagged edges occur on the printed image but are not visible on the QA workstation call for service of the laser printer Record the results of your evalua tion on the Monthly Report Form Note It is normal for the T object to demonstrate some level of jagged edges under magnification however they should not be visible to the unaided eye Compare the most recent image against the baseline image to establish any change using 2X magnifi cation Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 15 Image Noise and Artifact Objective Review the phantom image for the presence of elevated noise or artifact This evaluation can be used to inspect images from the IP CR Reader and hardcopy printer Frequency Monthly as part of normal phantom evaluation or as needed Procedure 1 Use the image produced in the Relative S Number Calibration test and proceed to Step 3 or erase the QA designated IP using the secondary erasure mode of your CR image reader to produce a new image 2 Expose and process the IP as described in the
34. port Form Precautions Some printers such as the Fuji Thermal Dry Imager FM DP2636 and FM DP 3543 require a special optical filter to be installed in X Rite model 301 301RS and 331 den sitometers Filter kits are available from FMSU Contact your Fuji Account Manager for information This added filter does not affect density measurements on other film types Check with your printer manufacturer if a compensation filter is needed 10 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Performance and Corrective Action S Number Evaluation S variation should be no greater than 20 of the established standard If your results exceed this level the following steps should be taken to further investigate 1 Repeat the test If results change you may have an intermittent exposure problem in the x ray generator 2 If results are still beyond tolerance expose the phantom in the second qualified room to confirm if the error exists in the CR Reader or the exposure room Call appropriate service as needed Hardcopy Evaluation When printing hard copy images always be sure that the laser printer is freshly calibrated and in control and that the image processing parameters are unchanged from the baseline exam Compare results against the previously established baseline optical density of the phantom image Variation should not be greater than 0 15 optical density OD If a greater difference exists recalibrat
35. s The patient lists on workstations such as the Fuji QA WS 771 can be sorted by selecting S number in ascending and descending order Frequency On a monthly basis review S numbers and L values on patient images Equipment Needed Patient images soft and or hardcopy Image Review Log Sheet Procedure 1 The S Sensitivity number and the L Latitude value is presented with the output image The S number though not an absolute value can be used to help determine if optimal exposure settings were used to obtain clinically acceptable images A review of the S numbers and L values can be done as the images are acquired 2 Any trend indicating that exposures are greater than necessary should be investigated Digital imaging systems such as CR will maintain proper density as dose is reduced As dose is reduced noise increases Exposure values should be established at the lowest level that produces images of low noise and good image quality Each clinical facility is responsible for setting their own S number criteria 3 The L value can be used to determine if the appropriate portion of the recorded expo sure was used to form the output image Typically L values range from 1 7 to 2 3 Only extreme variations will warrant further investigation This will be manifested in either very high or very low contrast images and typically represents images that are the result of grid cut off
36. softcopy review systems create a log of repeated images 2 Calculate the repeat rate by comparing total image acquisition to those repeated Evaluate each image for the reason it was repeated and categorize based on previous experience with film screen imaging New categories may be added such as Improper Menu Selection With CR it will be important to determine if an addition al exposure was actually made as it is often possible to correct images at the work station Performance and Corrective Action The repeat rate should be below 5 A repeat category that is significantly higher than others indicates an area for potential improvement Identifying the common cause of repeats can be used to determine if additional training or review is needed Use the information obtained between the Review Image Quality and Review S Number and L Value together with the Repeat and Reject analysis test to search for areas of improvement Programs such as the Fuji Certified Trainer or Advanced Image Processing help facilities maximize the benefits of Computed Radiography 34 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Image Consultation Training Objective Department turnover often requires scheduled revisits by Fuji Imaging Specialist Schedule imaging specialist consultations for Image Optimization or on site Educational Seminars to maintain a consistent level of technical expertise in your department Freq
37. table FUJIFILM Medical Systems U S A Copyright 2000 Gi FUJIFILM Image Review Log Sheet Date PT S Name or Comments I D Number Note Any images that need to be reviewed by a Fuji Imaging Specialist should be placed on this log Include any additional information such as technique grid or positioning issues A copy of this log should be placed in all areas where images are reviewed Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 4 IP Maintenance Log Cleaning and Inspection Records YEAR IP Date of RZE ue Number Installation Size P lt AUS ANUS QS VP eg Q S9 qQ Quarterly Comments 42 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Workstation Monitor Checklist Cleaning and Inspection Records MONTH YEAR Monitor Date of Number Installation SMPTE or Phantom Test Results Additional Comments Ei FUJ FILM FUJIFILM Medical Systems U S A Copyright 2000 43 Repeat Reject Analysis Report Form TECH MENU HIGH S LOW S EXAMINATION POSITION MOTION ERROR SELECTION NUMBER NUMBER OTHER SKULL Skull Facial B
38. the CR image reader erasure lamp mechanism Semi annually Single Exposure Confirms accuracy of workstation measure ment tools and image printer scale Semi annually Series of Exposures Confirms EDR function and CR image reader linearity Gi FUJIFILM A Laser Jitter Test Object 1 6mm Pb D 10 cm points for Workstation amp Printer 8 total Scale Accuracy Size 0 5 mm B1 Contrast Patch Outer Circle 0 15mm Pb Diameter amp Depth Inner Circle 0 5mm Pb EL left EC center ER right B2 Contrast Patch Outer Circular hole Measuring Points for Shading Correction 0 0mm cu Inner Circle 0 7mm cu amp Sensitivity 19mm Diameter 3 0mm Lucite removed C Sharpness Test Tool F Cassette Positioning Locator Anode End does not appear on image Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 7 Establishing a Baseline Phantom Image Choose an x ray room for phantom exposure that produces consistent exposures has a good choice of small mA stations and can create a non grid exposure at a distance of 60 inches or more cassette can be placed on the floor Newer generation x ray equipment with digital kVp settings may produce more accurate and repeatable exposure settings from month to month It is important to qualify a second x ray room if available to compare test results that may have been caused by an exposure related malfunction of the primary x ray room Move the x ray tube to a location away fro
39. tion and Image Processing Procedures Complete the Secondary Erasure cycle on your control IP cassette If the exposure unit has not been used within 90 minutes perform the manufacturer s tube warm up procedure Position the phantom directly on top of the control 14 x 17 cassette matching the orientation strip at the established distance of no less than 60 inches A lead apron should be placed behind the cassette to reduce backscatter Collimate the beam one inch outside the frame of the cassette The orientation strip must always be at the anode end of the x ray tube Expose the phantom at 80 kVp and the pre established mA and time settings to produce your QA image When setting up your program refer to Establishing a Baseline Phantom Image on the previous page Do not process immediately Wait 10 minutes before proceeding Take your exposed IP cassette to an available IDT Input your test image demographics for proper identification From AR anatomical region on the IDT select the Test region typically found on the second page From Test select the Contrast menu Verify that the Contrast menu is set for 1 1 Format and the EDR option is Semi mode Also confirm that there has been no change in SS or CS i e 1 0 1 0 from baselines Process your IP Lock your baseline image on the QA workstation for comparison with future images Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 9 Relat
40. uency Semi annual or when turnover in radiology personnel requires Procedure It is good practice to maintain on going image consultation or training programs with your Fuji Imaging Specialist Image Optimization reviews imaging and exposure proce dures and promotes improved efficiency through custom menu creation to meet each facility s specific needs In addition one and two day on site educational seminars are available These seminars include The FCR Certified Trainer Program Advanced Image Processing and FCR Quality Assurance Contact your Fuji Account Manager or Imaging Specialist for details Performance and Corrective Action On going educational seminars are essential for maintaining image quality Ei FUJIFILM FUJIFILM Medical Systems U S A Copyright 2000 35 Preventative Maintenance of CR Reader Objective It is good practice to follow the Preventative Maintenance PM schedule set up by the manufacturer of your CR system Routine scheduled Preventative Maintenance assures that your system is accurately calibrated and operating properly Frequency Semi annually Procedure The scheduled Preventative Maintenance performed by a Fuji Service Engineer covers all operating systems of the CR Reader Routine scheduled service on your FCR system ensures calibration cleaning and adjustment of the laser optics light guide and transport systems Performance and Corrective Action On going Preventative Maintenance
41. uide 24 FUJIFILM Medical Systems U S A Copyright 2000 Fi FUJIFILM Erase Unused Imaging Plates Objective The imaging plates used in CR are sensitive to radiation from many sources including scatter and background radiation Imaging plates unused for extended times can produce images of lower image quality decreased contrast and higher noise For this reason it is good practice to erase IP s at least every 48 hours if they have not been used Frequency Daily or IP s that have not been used within 48 hours Equipment Needed CR Reader Department IP s in Cassettes Procedure 1 At the CR Reader select Secondary Erasure for any IP that may have been exposed to scatter radiation or may not have been used in the past 24 hours To erase a direct x ray exposure select Primary Erasure 2 Insert cassette into the CR Reader 3 Once erasure is complete remove cassette from CR Reader and return it to routine use 4 CR Reader will return to routine processing upon completion of each erasure process Performance and Corrective Action Any energy absorbed by the IP will remain trapped until the erasure process has been com pleted Ambient radiation can increase mottle within the image lower contrast and affect S value reading IP s that are suspect of being exposed to scatter or direct x ray exposure should be erased prior to use IP s should be stored away from both direct and in direct radiation To reduce the effects of
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