SenoScan Enterprise Acquisition Station Operator Mamual Issue 1, Revision 2 APPENDIX A LOGS, WORKSHEETS, AND CHECKLISTS A-l_ GENERAL ‘This Appendix contains examples of the various charts which are referenced in the preceding sections of this manual. These charts, depending upon utilization, may be formatted as logs, records, worksheets, and/or checklists. A-2 PURPOSE OF APPENDIX ‘The pages contained in this appendix are example copies which may be used as copy master originals from which actual working documentation can be made. e o CONTENTS ‘This appendix contains the following documentation: Chart A-1_ Phantom Image Acquisition Test Log Chart A-2 Printer Daily Test Log Chart A-3 Phantom Image Quality Weekly Test Log Chart A-4 Detector Calibration and Flat Field Weekly Check Log Chart A-5 Rejected Image Log Chart A-6 Reject Report Quarterly Summary Worksheet Chart A-7 System Resolution Monthly Check Log Chart A-8 System Operation Monthly Checklist Chart A-9 Compression Force Semi-annual Test Log Chart A-10 Physicist Annual Quality Control Tests Summary Records, Worksheets, and Cheeklises A-M/BlankSenoScan Enterprise Acquisition Node Operator Manual Phantom Image Acquisition Test Log _ Start Date: Machine ID: Technique: kvp mA Background Mean 9C Basen Ve) Wek 12 3 4 6 6 7 6 0 WH RM we Ym mm mm ww ia Background StDev gag a 0 Wek 12345 6 7 8 BO eo 8 7 te wom 2 mm a ws Logs, Records, Worksheets, and ChecklistsIssue I Revision 000 Disk/Background ADU Level Difference Measurements Backoround | pick | ADU Lovet Background | isk | ADU Level weok | Mean | stdev | Mea | Difference Woe | mean | sidev | Mean | Difference 1 “ 2 6 3 16 4 ” 5 18 6 ‘9 7 20 8 a 9 Ea 10 23 " 2 ” 25 18 6 QC Baseline Values (5 Day Averages) Background | Background | ADU Level ‘Mean ‘StDev Difference ADU Level Difference (G0 Bassine vave) Wek 1 23 4S FT RH MWHNN EH HT ww WN DH Mw w A-3/BlankSenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-2. Printer Daily Test Log Printer 1D: Refer to printer manufacturer’ Quality Control Test Procedure. Log pass/fail in appropriate column, Date Tech ID Pass Fail fn Failure of this test indicates a potential problem which ean impact the validity of a patient record. ‘The printer must be removed from service and must not be used to print patient records until it is repaired and this test is passed. Records, Worksheets, and Checklists A-5tBlankSenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-3. Phantom Image Quality Weekly Test Log Machine 1D: ‘Technique for Test: KVp__mA_ Window Value: Level Value: Note: Use the same windowfevel vatues (420) ‘each time this test is accomplished. No. of Objects Visualized in image || Result Date | TechiD |e [Speck Gps] Masses | Pass | Fai) Avtfact Description ae te rt te rt te rr Hee rt ie rT iy v7 ney 7 BH vt Hee it Hee ae ae ae HEE it Records, Worksheets, and Checklists ‘A-7IBlankSenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-4. Detector Calibration and Flat Field Weekly Check Log Machine ID: Daily || Flat Field RO! Mean Values % Deviation Flat toch | “au | Ferien aves | __eDevaon | te vate | TA] C2, — Top | ton Tiower]iowerl top | top Jiowor]iower] Fie ate | 1D Pass com | tok | mane | in| sgn | fom | ane | om” [ne "ase Failure of the Daily Calibration and/or Flat Field test indicates a problem in the SenoSean detector or imaging subsystem. The system must be removed from service and repaired before it may be used to image patients. Records, Worksheets, and Checklisis A-9(Blank‘SenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-5. Rejected Image Log Machine ID: Tech | Reject Other Reason for Reject Reject Image Saved As: Date | ID | Code (Use when Reject Code is N/A.) (Filename) vt Reject Code Descriptions Patient Motion ‘ADU Count Too High | 10 [ No Image Image Artifacts | 11 | Miscellaneous 1A | Positioning - LCC 1B | Positioning - RCC. 1€ | Positioning - LMLO 10 | Positioning - RMLO_ Patient Artifact Poor Compression ‘ADU Count Too Low Poor image Quality | 12 | Unknown olalels 6 7 8 9 Mechanical Failure Records, Worksheets, and Checklists Al UBlank‘SenoScan Enterprise Acquisition Station Operator Manual Issue 3, Revision 2 Chart A-6. Reject Report Quarterly Summary Worksheet Machine ID: Date: Tech ID; Total Images Taken During Period: Established Baseline Rate:_____%" eres Cause Neuere | “elect | Pagan" | Passirairs 1A Positioning - LCC - % 16 Positioning - REC % % 1c Positioning - LMLO % % | 1D Positioning - RMLO % % | 2 Patient Motion % % 3 Patient Artifact % % 4 Poor Compression: ~ % % a 5 ‘ADU Count 00 iow % % 6 ADU Count too high T % % 7 Image Artifacts % % | 8 Poor Image Quality % ” % je Mechanical Failure % % No Image % ~ % z Miscellaneous % % 2 Unknown % % a OVERALL % “Enter rate from previous analysis. Reject Rate in % = Number of Rejects IF this is frst analysis, enter ‘none! Total Images “Pass = baseline rate #2 Corrective Action Required: Follow up: Records, Worksheets, and Checklists A-13/Blank‘SenaScan Enterprise Acquisition Station Operator Manual Issue }, Revision 2 Chart A-7. System Resolution/Scan Speed Uniformity Monthly Check Log Machine ID: Date | Tech iD |. Parallel (pass = 27 Ipinm ‘Standard Imaging Mode 210% modulation) High: (pas: '-Res Mode 11.4 Ip/mm: 5% modulation) [ Perpendicular Center Left Right Parallel Perpendicular} Requirement: Failure of the System Resolution/Scan Speed Uniformity Check indicates a problem in the SenoScan detector, imaging subsystem, or scan drive. The system must be removed from service and repaired before it may be used to image patients. Records, Worksheets, and Checklists A-15(BlankSenoScan Enterprise Acquisition Station Operator Manwal Issue 1, Revision 2 Chart A-8. System Operation Monthly Checklist (Sheet 4 of 3) Machine ID:, Pass | Fail 1. Rotate the Gantry clockwise until it stops. Verify that the gantry moves at a constant rate without hang-ups or unusual noise. Verify that the maximum angle of rotation shown on the LED display is +125° + 2°. 2. Rotate the gantry counterclockwise until it stops. Verify that the gantry moves at a constant rate without hang-ups or unusual noise. Verify that the maximum angle of rotation shown on the LED display is -187° + 2°, 3. Rotate the gantry back to home position until the gantry LED display indicates 0°. Verify that the gantry arm is in the vertical position, 1. Lower the gantry (at 0° rotation) until it can go.no lower. Verify that the gantry moves al a constant rate to its lower limit without hang-ups or unusial noise. 2. Raise the gantry (at 0° rotation) until it can go no higher. Verify that the gantry moves at a constant rate to its upper limit without hangups or unusual noise. 1. Place an object, such as the ACR phantom on the breast support and compress it to maximum, compression. Measure the thickness between the breast support and the compression paddle and verify that the displayed thickness is within 5 mm of the actual measurement, 2. While the paddle is lowered to 9 cm or less (on display panel), attempt to rotate the gantry. Verify that rotation is not possible. While the paddle is lowered within 9 em or less, attempt to elevate or lower the gantry. Verify that gantry motion is not possible. 4, Verify that the manual compression knob operates at all times, even when no power is applied to the system.) * See Waring at end of this chart. (Continued on next page.) Records, Worksheets, and Checklists A-17/Blank‘SenoSean Enterprise Acquisition Station Operator Mamual Chart A-8. System Operation Monthly Checklist Machine ID: Rotation * 1. Rotate the Gantry clockwise until it stops. Verify that the gantry moves at a constant raie without hang-ups or unusual noise. Verify that the maximum angle of rotation shown on the LED display is +120° + 2°. 2. Rotate the gantry counterclockwise until it stops. Verify that the gantry moves at a constant rate without hang-ups or unusual noise. Verify that the maximum angle of rotation shown on the LED display is -185°* 2°. 3. Rotate the gantry back to home position until the gantry LED display indicates 0®. Verify that the gantry arm is in the vertical position. Elevation * 1. Lower the gantry (at 0° rotation) until it can go no lower. Verify that the gantry moves at a constant rate to its lower limit without hang-ups or unusual noise. 2. Raise the gantry (at 0° rotation) until it can go no higher. Verify that the gantry moves at a constant rate to its upper limit without hangups or unusual noise. Compression * 1. Place an object, such as the ACR phantom on the breast support and compress it to maximum compression. Measure the thickness between the breast support and the compression paddle and verify that the displayed thickness is within £5 mm of the actual measurement. . While the paddle is lowered to 9 cm or less (on display panel), attempt to rotate the gantry. Verify that rotation is not possible. 3. While the paddle is lowered within 9 cm or less, attempt to elevate or lower the gantry. Verify that gantry motion is not possible. 4, Verify that the manual compression knob operates at all times, even when no power is applied to the system.) See Warning at end of this chart. (Continued on next page.) Records, Worksheets, and Checklists Issue }, Revision 2 (Sheet 1 of 3) Pass | Fail A-17/BlankSenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-8. System Operation Monthly Checklist Machine ID: Emergency Stop * 1. Depress the Emergency Stop button, Verify that no motions (rotation, elevation, and (motorized) compression are possible. 2. Release the Emergency Stop button. Verify that all motions are now possible. Automatic Decompression * 1. Disable Automatic Decompression. Lower the compression paddle to a displayed compressed thickness of 4-5 cm. Acquire an image. Be sure to hold down the x-ray button until the scan is completed. Verify that the compression paddle does NOT raise on completion of the scan. 2. Enable Automatic Decompression. Raise the paddle to a displayed thickness of 4-5 cm and acquire an image. Be sure to hold down the x- ray button until the scan is completed. 3. Verify that the compression paddle automatically raises to a thickness value of 16.5 cm ( 1.0 em) as observed on the acquite sereen, 4. Raise the paddle to a displayed thickness of 17 cm and acquire an image. Be sure to hold down the x-ray button until the scan is completed. 5. Verify that the compression paddle does NOT raise on completion of the scan, Light Field 1, Press the light field button. Verify that the light field illuminates, then extinguishes after 15 seconds. 2. Press the light field button to illuminate the light field, wait 5 seconds then press again. Verify that the light field extinguishes when the button is pressed the second time. 3. With the light field off, step on the footswitch fo lower the compression paddle. Verify that the light field illuminates, then extinguishes after 15 seconds, * See Waming at end of this chart. (Continued on next page.) Records, Worksheets, and Checklists (Sheet 2 of 3) 4-19/BlankSenoScan Enterprise Acquisition Station Operator Manual Issue 1. Revision 2 Chart A-8. System Operation Monthly Checklist Machine ID: I Audible and Visual X-ray Indicators * 1. Verify that, during image acquisition, the x-ray indicators are illuminated for the duration of the x-ray exposure. 2. Verify that during the image acquisition, the x-ray warning lamp outside the room entry door is illuminated (if applicable), 3. Verify that during the image acquis Door Interlock Check (if applicable) ion, the audible alarm is activated. 1. Verify that image acquisition is disallowed when room entry door is open. Visual Inspections * 1, Inspect the Breast Support surface for eracks, chips, and sharp edges, 2. Inspect all paddles for cracks, chips, sharp edges, and separation at the chest wall and where they attach to the paddle frame. 3. Inspect the patient face shield for cracks, chips, and sharp edges. 4, Inspect the technologist shield for cracks. 1 * See Waning at end of this chart. from service and do not use it for patient ex: the faulty item is repaired. (Sheet 3 of 3) Failure of any of the above tests marked with an asterisk (#) indicates that a safety hazard may exist. Remove the system aminations until Failure of tests not marked with an asterisk docs not represent a safety hazard and the system may be used for patient examinations pending repair. If the faulty item is not repaired within 30 days the system must be removed from service. Records, Worksheets, and Checklists A-2UBlankSenoSan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-9. Compression Force Semi-annual Test Log Machine ID; Measured Compression Force ae Pass | Fail Power (1) ‘Manual (2) Displayed (3) | Pass | Fal Date | TechID (1) Power compression force must be 25-46 lbs (2) Manual compression force must be equal to or better than (1). {) Force displayed must be newton equivalent (¢ 5%) of measurement obiained in (1). To convert, use: 1 Ibf= 4.45 N or 1 N= 0.225 If Records, Worksheets, and ChecklistsSenoSean Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-10. Physicist Annual Quality Control Tests Summary (Sheet 4 of 4) Document #: ____. Revision: Machine ID: Date: — Physicist performing tests: Facility: X-ray Field, Chest Wall Missed Tissue, and Light Field Checks X-ray Field to Markings: Pass Fail 100 x (IL +R) 100 x (AL+ [Pl Standard 100 GLI + IRI) x (Al+ IPL) sip <7 nd SIDS? High-Res Digital Image to X-ray Field . standard 100 =D <5 ca sD * High-Res soo lB =A) <9 Standard Sip * High-Res . Standard 100 x 4A) <9 - ‘SID High-Res Standard es Hiigh-Res Missed Tissue at Chest Wall P’< 8.5 mm ee Light Field to Markings and X-ray Field: All edges of light ficld outside of x-ray field. Standard. High-Res All edges < than 12 mm outside markings. Standard High-Res Records, Worksheets, and Checklists A-25/Blank‘SenoScan Enterprise Acquisition Station Operator Manual Issue 1, Revision 2 Chart A-10. Physicist Annual Quality Control Tests Summary —_ (Sheet 2 of 4) Date: Document #: Revision: Physicist performing tests: Machine ID: Facility Compression Paddle Alignment Pass Fail ‘Vertical edge of the posteriori edge of the compression paddle is not visible on the acquired image. Vp Accuracy Test Average measured kVp for each selected kVp ee setting is within # 5% of the select KVP set- ting. Coefficient of variation for each selected kVp a does not exceed 0,02 Linearity, Reproduei ity, and Accuraey Linearity < 0.08 Reproducibility < 0.035 for each technique Half Value Layer t, In [2E,/ Ep] —t, In [2E,/ Eo} fae a me Ey - [ in [E/E] etry — Average Glandular Dose and Output Average glandular dose to a standard 4.2 em ez compressed breast does not exceed 300 mrad. Phantom Image Acquisition Test No obvious artifacts Background StDev is less than 50 ADU Background Mean within +100 ADU of baseline ADU Level Difference within -100/+300 ADU of baseline Records, Worksheets, and Checklists A-27/BlankSenoScan Emerprise Aequisition Station Operator Maral Issue J, Revision 2 ChartA-10. Physicist Annual Quality Control Tests Summary (Sheet 3 of 4) Date: Document # Revision: Physicist performing test Machine ID: Facility: Image Quality Pass Fail Visualize at least 4 fibers, Visualize at least 3 calcification groups. Visualize at least 3 masses. System Resolution/Scan Speed Uniformity Standard Mode: Visualize 7 Ip/mm pattern, | 8 both parallel and perpendicular directions, cece (5 transitions, 10% modulation at all locations. SI Parallel Center Left Right ea ee Fz | | Perpendicular High-Res Mode: Visualize 11.1 Ip/mm pattern, ea both parallel and perpendicular directions, 5 transitions, 5% modulation Flat Field Test Manual Method Automated Method No unexplained artifacts visible with window az : width > 800. Mean deviation between comers and center within 20% aM | Geometric Distortion and Resolution Uniformity With @ 40 mesh copper sereen, there is no i i distortion or blurring in any area of the image. a Records, Worksheets, and Checklists: 4-29/BlankSenoSean Enterprise Acquisition Station Operator Manwal Issue 1, Revision 2 Chart A-10. Physicist Annual Quality Control Tests Summary (Sheet 4 of 4) Date: __ Document #: Revision Physicist performing tests: ‘Machine ID: Facility Automatic Decompression Control With Auto Release Compression disabled, the ee compression paddle does not raise at the end of the scan, With Auto Release Compression disabled, the ea ‘manual compression knob can be turned to raise the compression paddle manually. When power is off at the gantry, the manual ea compression knob can be tured to raise the compression paddle manually. System Artifacts ‘There are no unexplained artifacts in the image ee when viewed at a window width of 2 800. Records, Worksheets, and Checklists A-31/B lank