附件八之二_GE Senographe Essential(範例)
醫院：
檢查人員簽名：
覆核人員簽名：
TEST RESULTS RECORD FORMS
Daily and Weekly Tests
Facility : ………………………………… Year Date 1 Initials Monitor cleaning (daily) Seno Advantage Viewing Conditions Flat Field test (daily) (weekly) Image Quality test (weekly) Viewing Conditions (weekly) Year Date 17 Initials Monitor cleaning (daily) Seno Advantage Viewing Conditions Flat Field test (daily) (weekly) Image Quality test(weekly) Viewing Conditions (weekly) Remarks: A A Action Limit: If the reading room configuration has changed, the source of the problem must be identified, and corrective action taken, before any further mammographic images are reviewed or interpreted using the Seno Advantage. 18 19 20 21 22 23 ROOM: ……………………………………..A Month 8 9
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Month 24 25 26 27 28 29 30 31
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Image Quality and MTF Measurement Test Record (1/3)
Use this form to record the results of Flat Field, Phantom Image Quality and CNR and MTF Measurement tests:
Year Month Date Initials Flat Field Brightness non-uniformity High frequency modulation Bad pixel verification Bad ROI SNR non-uniformity Phantom Image Quality AWS: Zoom Window Width (WW) Window Level (WL) No. of fibers No. of specks groups No. of masses Printer: No. of fibers No. of speck groups No. of masses Test object used:
Phantom Used:
Flat Field Test Result LSL: N/A Brightness non-uniformity High frequency modulation Bad pixel verification Bad ROI SNR non-uniformity
2
USL 10.00 0.80 100 0.00 40
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Image Quality and MTF Measurement Test Record (2/3)
Determination of Operating Level CNR Date Day 1 Day 2 Day 3 Day 4 Day 5 CNRol CNRol (Operating Level CNR) = Average of 5 CNR values, one acquired on each of five consecutive days. Notes: 以下情形必須重新建立 CNRol 1.更換 X 光球管。 2.更換 Rh 濾片。 3. 更換 IQST device。 4. 更換鉛柵。 5. 更換 detector。 6. detector 增益值進行再校正。 CNR Date CNR Date CNR
3
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Image Quality and MTF Measurement Test Record (3/3)
Year Month Date Initials MTF + CNR Measurements MTF parallel at 2 lp/mm MTF parallel at 4 lp/mm MTF perpendicular at 2 lp/mm MTF perpendicular at 4 lp/mm Contrast-to-Noise Ratio (CNR) Change in CNR Action Limit : The system passes the MTF Measurement test if the following conditions are met: MTF Parallel at 2lp/mm > 49% MTF Parallel at 4lp/mm > 18 MTF Perpendicular at 2lp/mm > 49% MTF Perpendicular at 4lp/mm > 18% For each condition that is met, the Status will be Pass. The system passes the CNR Measurement test if the change in CNR does not exceed 0.2. If this condition is met, the Status will be Pass. IQST Device Reference No:
Notes :
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
MTF Measurement and AOP Mode and SNR Check Records
Frequency: Monthly Room: ………………………………. Year Month Date Initials AOP Mode Check; mAs or F/n. See Guidance section 5 AOP Mode and SNR Check1 regarding a method to record these results. 25 mm acrylic 50 mm acrylic 60 mm acrylic AOP Mode Check; SNR values: 25 mm acrylic 50 mm acrylic 60 mm acrylic 測試標準 : (1) SNR as mean/sd: SNR 值必須超過 50 (2) AOP Mode 測試必須符合以下結果 : Unit: …………………………………
5
附件八之二_ GE Senographe Essential (範例)
醫院： Notes:
檢查人員簽名：
覆核人員簽名：
MONITOR CALIBRATION CHECK
Frequency: Monthly Room: ……………………………….. Date Month Initials Monitor 0%-5% contrast 95%-100% contrast Gray steps Alphanumerics line-pair images (center) line-pair images (corners) • Action Limit: a. The 0%-5% contrast and the 95%-100% contrast shall be visible. b. Each step from 0% to 100% shall be distinguishable from the adjacent ones. c. The alphanumeric characters shall appear sharply focused. d. The high-contrast line-pair patterns representing 3-pixels-on/3-pixels-off and 2-pixels-on/2pixelsoff must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the line-pair patterns. The high-contrast line-pair patterns representing 1- pixel-on/1-pixel-off must be distinguishable at the center and the corners of the display for the horizontal orientation of the patterns. Failure to distinguish the 1-pixel-on/1-pixel-off, high-contrast, vertical line-pair patterns does not constitute failure of the test. • Use of the Test Results: The ability to distinguish the low-contrast line-pair patterns is not a requirement for this test. If these conditions are maintained, the monitors are considered correctly calibrated.
6
Unit: ………………………………
Left (pass/Fail)
Right (pass/Fail)
附件八之二_ GE Senographe Essential (範例)
醫院： 檢查人員簽名： 覆核人員簽名： If the system fails the test, the source of the problem must be identified and corrective action taken, before any further mammographic images are reviewed or interpreted using the Seno Advantage.
Visual Checklist Record
Frequency: Monthly Room: ……………………………… Year: Month Day Initials Gantry: Angulation Indicator Locks (all) Field Light Smoothness of motion Inspect all paddles for cracks Control Panel: Switches/indicators Display Technique charts Other: Cleaning fluid Unit: ………………………………….
Pass: P Fail: F
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名： Does not Apply: N/A
覆核人員簽名：
Record of Check
Year Month Date Initials Visual Inspection Repeat Analysis Auto Compression: Manual
Radiologist Review Physicist Review
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Repeat Exposure Record Sheet - Manual Method
Use this chart to record all repeated exposures that caused the patient to receive additional dose beyond that of the normal exam. Period covered: Dates From…………………………. To ………………………….
Study #
Causes
No. of Times
Date
Technologist
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附件八之二_ GE Senographe Essential (範例)
醫院： Causes: 1 2 3 4
檢查人員簽名： Positioning Patient Motion Exposure too low (noisy image) Exposure too high (image saturation)
覆核人員簽名： 5 6 7 8 Incorrect Patient ID X-ray Equipment Failure Blank Image Other
Repeat Exposure Analysis – Manual Method
Use this chart to analyze all repeated exposures that caused the patient to receive additional dose beyond that of the normal exam. Period covered: Dates From……………………….. To ……………………………
Cause 1 2 3 4 5 6 7 8 Positioning Patient Motion Exposure too low (noisy image) Exposure too high (image saturation) Incorrect Patient ID X-ray Equipment Failure Blank Image Other
No. of Repeat Exposures
Percentage of repeats by category
Total of Repeat Exposures (R) Total of All Exposures (T) Repeat Exposure Percentage (R/T x 100)
10
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Repeat and Reject Exposure Analysis – Automated Method
Use this chart to record the analysis of repeated and rejected exposures. Period covered: Dates From……………………… To……………………….. Cause Positioning Patient Motion Poor Compression Improper Detector Exposure X-Ray Equipment Failure Equipment Artifacts Blank Image Clinical Artifacts Incorrect View Marker QC, Acceptance Tests, Calibration Interventional Image (e.g., wire loc.) Other Number of Percentage of Number of Percentage of Repeats Repeats Rejects Rejects
Total Repeats + Rejects Total Repeats Total Rejects Non-Clinical Repeats+Rejects Total number of exposures Total Repeat+Reject rate Total Repeat rate
11
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名： Clinical Repeat rate
覆核人員簽名：
Summary of Mammography Equipment Evaluation for Senographe DS Mammographic System (Annual QC Tests)
Facility Name: Address:
Date of Installation Date of Survey 年度品保專業人員
Unit Ser. No. Room IDSU Signature
TEST TESULTS
1. Flat Field and Image Quality Checks Reference: Flat Field and Phantom IQ Test Pass Brightness Non–uniformity High Frequency Modulation Bad Pixel Verification Bad ROI SNR Non–uniformity Requirement: All Flat Field checks must pass.
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Fail
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名： AWS Printer
No. of Fibers No. of Speck Groups No. of Masses Requirement: 4 largest fibers, 3 largest speck groups, and 3 largest masses must be detected.
2. CNR and MTF Measurement Reference: CNR and MTF Measurement MTF parallel at 2 lp/mm MTF parallel at 4 lp/mm MTF perpendicular at 2 lp/mm MTF perpendicular at 4 lp/mm CNR Requirement: MTF at 2 lp/mm > 49% MTF at 4 lp/mm > 18%.
3. AOP Mode and SNR Check Reference: AOP Mode and SNR Check
Exposure Parameters–AOP, STD Mode mA Acrylic Thickness (mm) Track/filter kV s 25 50 60 Requirement: Exposure Parameters–AOP, STD Mode Acrylic Thickness (mm) Track/filter mAs kV 25 Mo/Mo 20 - 60 26 50 60
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SNR
SNR > 50 > 50 > 50
Rh/Rh Rh/Rh
40 - 90 45 - 95
29 30 or31
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
4. Collimation Assessment Reference: Collimation Assessment Pass Deviation between X-ray field and light field is less than 2% of SID. X-ray field does not extend beyond any side of the image receptor by more than 2% of SID. Chest wall edge of the field extends to the chest wall edge of the image receptor. Chest wall edge of compression paddle not visible in image and does not extend beyond image receptor by more than 1% of SID. Requirement: All collimation requirements must pass. 5.Evaluation of Focal Spot Performance Reference: Evaluation of Focal Spot Performance Resolution Limit (lp/mm) Bars paral. AC axis Bars perpr. AC axis M R M R o h o h Fail
Anode track Contact geometry 1.5X Magnification
Requirement: In the contact mode or the 1.5X magnification mode, measurements made with thebars parallel to the anode-cathode axis must be at least 13 lp/mm; measurements with the bars per- pendicular to the anode-cathode axis must be at least 11 lp/mm.
6. Sub-system MTF Reference: Sub-System MTF Measurement Large Focal Spot Track M o R h M o R h M o
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Small Focal Spot Freq. (lp/mm) 5 5 5 5 8 Pass Fail
Axis Width Width Length Length Width
Freq. (lp/mm) 2.09 2.09 2.09 2.09 3.93
Pass
Fail
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
R Width 3.93 8 h M Length 3.93 8 o R Length 3.93 8 h Requirement: All sub-system MTF requirements must pass.
7, Breast Entrance Exposure, Average Glandular Dose, and Reproducibility Reference: Breast Entrance Exposure, Average Glandular Dose and Reproducibility Coefficient of Variation of mAs Coefficient of Variation of air kerma
Mean glandular dose to Standard breast
AOP, CNT mode AOP, STD mode AOP, DOSE mode
other (specify parameters) Requirement: The maximum acceptable coefficient of variation for both mAs and air kerma is 0.05. The mean glandular dose to the Standard breast must not exceed 3 mGy (0.3 rad) per view.
8. Artifact Evaluation and Flat Field Uniformity Reference: Artifact Evaluation and Flat Field Uniformity Pass Artifacts are not apparent or are not expected to mimic or obscure clinical information. Requirement: Artifact requirements must pass. Fail
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附件八之二_ GE Senographe Essential (範例)
醫院： 檢查人員簽名： 9. kVp Accuracy and Reproducibility Reference: kVp Accuracy and Reproducibility
覆核人員簽名：
kVp error at lowest measurable clinical kVp (%) kVp error at most commonly used clinical kVp (%) kVp error at highest available clinical kVp (%)
Requirement: The kVp shall be accurate within ± 5 percent of the indicated or selected kVp at eachof the above measurement points.
Coefficient of variation at most commonly used clinical kVp setting
Requirement: At the most commonly used clinical setting of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.02.
10. Beam Quality Assessment (Half-Value Layer Measurement) Reference: Beam Quality Assessment (Half-Value Layer Measurement) Pass Half-value layer equals or exceeds minimum allowed under MQSA. Requirement: Half-value layer must equal or exceed MQSA minimum value. Fail
11. Radiation Output Reference: Radiation Output Value Radiation output Requirement: The system shall be capable of producing a minimum output of 7.0 mGy air kerma per second (800 mR per second) under specified conditions. Pass Output maintained for at least 3.0 sec Requirement: The system shall be capable of maintaining the required minimum radiation output averaged over a 3.0 second period.
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Units
Fail
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
12. Mammographic Unit Evaluation Reference: Mammographic Unit Assembly Evaluation Pass System meets requirements for motion of tube-image receptor assembly. System meets requirements for compression paddle decompression. Fail
Requirement: The system shall meet the MQSA requirements for motion of the tube-image receptorassembly and for compression paddle decompression.
Flat Field Test
Phantom Used : Measurement Brightness Non–uniformity High Frequency Modulation Bad Pixel Verification Bad ROI SNR Non–uniformity Requirement : All Flat Field checks must pass. LSL:N/A USL Pass/Fail
Image Quality Checks: AWS and SA
Phantom Used : Zoom AWS Score SA Score Pass/ Fail Requirement : 4 largest fibers, 3 largest speck groups, 3 largest masses must be detected.
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Window Width Window Level (WW) (WL)
No. of Fibers
No. of Speck Groups
No. of Masses
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
CNR and MTF Measurement
Phantom Used: IQST Device Reference MTF MTF MTF Contrast-toparallel at perpendicular perpendicular Noise Ratio 4 lp/mm at 2 lp/mm at 4 lp/mm (CNR)
MTF parallel at 2 lp/mm
Chang in CNR
Action Limit: The system passes the MTF Measurement test if the following conditions are met: MTF Parallel at 2lp/mm > 49% MTF Parallel at 4lp/mm > 18% MTF Perpendicular at 2lp/mm > 49% MTF Perpendicular at 4lp/mm > 18% For each condition that is met, the Status will be Pass. The system passes the CNR Measurement test if the change in CNR does not exceed 0.2. If this condition is met, the Status will be Pass. Date: Test Tool: . . . . . . . . . . . . . . . . . . .
AOP Mode and SNR Check
Exposure Parameters – AOP, STD Mode Acrylic Thickness (mm) 25mm 50mm 60mm Action Limit: The AOP Mode test is successful if the exposure parameters are in accord with the values specifiedin the following table. Requirement: Exposure Parameters – AOP, STD Mode Acrylic Thickness Track/filter (mm) 25mm 50mm
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Track/filter
mAs
kV
SNR
Pass/Fail
mAs 20 - 60 40 - 90
kV 26 29
SNR >50 >50
Mo/Mo Rh /Rh
附件八之二_ GE Senographe Essential (範例)
醫院： 60mm
檢查人員簽名： Rh/Rh 45 - 95
覆核人員簽名： 30or 31 >50
Collimation Assessment
Date: ………………………………….. Source to Image Receptor Distance (SID): …660mm………………………….. Deviation between X-ray field and light field: coin diameter is Field of View X-ray Tube Target Left Edge Deviation Right Edge Deviation Sum of magnitudes of left and right edge deviations Sum as % of SID Anterior Edge Deviation Chest Wall Edge Deviation Sum of magnitudes of anterior and chest edge deviations Sum as % of SID Use of Test Results: If the sum of left plus right deviations or anterior plus chest wall edge deviations exceeds 2% of the SID, the source of the problem must be identified and corrective action taken within 30 days of the test date. Difference between X-ray field and image receptor: coin diameter is
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Field of View X-ray Tube Target Left Edge Difference (absolute) Left Edge Difference (% of SID) Right Edge Difference (absolute) Right Edge Difference (% of SID) Anterior Edge Deviation (absolute) Anterior Edge Deviation (% of SID) Chest Wall Edge Deviation (absolute) Chest Wall Edge Deviation (% of SID) Chest wall edge of the field extends to the chest wall edge of the image receptor (yes/no) Use of Test Results: If the entire chest wall edge of the x-ray field does not extend to the chest wall edgeof the image receptor, or if the X-ray field extends beyond the image receptor by more than 2% of SID, the source of the problem must be identified and corrective action taken within 30 days of the test date.
Collimation Assessment (Cont.)
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附件八之二_ GE Senographe Essential (範例)
醫院： 檢查人員簽名： 覆核人員簽名： Alignment of chest wall edges of compression paddle and image receptor coin diameter is X-ray Tube Target Paddle Size Difference between compression paddle edge and image receptor edge at chest wall (absolute) Difference (% of SID), edge visible (Yes/No) Paddle Size Difference between compression paddle edge and image receptor edge at chest wall (absolute) Difference (% of SID), edge visible (Yes/No) Paddle Size Difference between compression paddle edge and image receptor edge at chest wall (absolute) Difference (% of SID), edge visible (Yes/No) Paddle Size Difference between compression paddle edge and image receptor edge at chest wall (absolute) Difference (% of SID), edge visible (Yes/No) Use of Test results: If the chest wall edge of the compression paddle is within the image receptor or projects beyond the chest wall edge of the image receptor by more than 1% of SID, the source of the problem must be identified and corrective action taken within 30 days of the test date.
Sub-System MTF Measurement
21
附件八之二_ GE Senographe Essential (範例)
醫院： Date: Test Tool:
檢查人員簽名： …………………………… …………………………….
覆核人員簽名：
Patient ID #:…………………………… FineView status at the start of the measurement (circle one) FineView status at the end of the measurement (circle one) Large Focal Spot Track Mo Rh Mo Rh Axis Width Width Length Length N(2.09) N(3.93) Ss Ns Sb Nb M(2.09) M(3.93) Disabled Disabled Enabled Enabled
Small Focal Spot Track Mo Rh Mo Rh Axis Width Width Length Length N(5) N(8) Ss Ns Sb Nb M(5) M(8)
where: Ss = the mean value in a region of interest (ROI) including only “space” material, Sb = the mean value in an ROI including only “bar” material, Ns = the standard deviation in an ROI including only “space” material, Nb = the standard deviation in an ROI including only “bar” material, N(f) = the standard deviation in an ROI including the bar pattern group of frequency f, and M(f) = the MTF at frequency f. f = 2.09 and 3.93 lp/mm for the large focal spot. f = 5 and 8 lp/mm for the small focal spot.
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Sub-System MTF Measurement (Cont.)
Sub-System MTF Measurement Results Large Focal Spot Freq. Pass Fail (lp/mm) 2.09 2.09 2.09 2.09 3.93 3.93 3.93 3.93 Small Focal Spot Freq. Pass Fail (lp/mm) 5 5 5 5 8 8 8 8
Track Mo Rh Mo Rh Mo Rh Mo Rh
Axis Width Width Length Length Width Width Length Length
Action Limit: The MTF values obtained in the test must exceed the Action Limits specified in the following table. Large Focal Spot Track Mo Rh Mo Rh Mo Rh Mo Rh Axis Width Width Length Length Width Width Length Length Freq. (lp/mm) 2.09 2.09 2.09 2.09 3.93 3.93 3.93 3.93 Action Limit 0.55 0.55 0.55 0.55 0.19 0.19 0.19 0.19 Small Focal Spot Freq. (lp/mm) Action Limit 0.30 5 0.30 5 5 5 8 8 8 8 0.34 0.34 0.08 0.08 0.11 0.11
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Breast Entrance Exposure, Average Glandular Dose and Reproducibility
Dosimetry system used ……………………….. Fieldsize ……………………….. Phantom ID ……………………….. Imaging Parameters and Reproducibility: Breast thickness Phantom Exposure Control Mode (AOP, Man.) Nominal kVp setting Target/Filter mAs setting Measured HVL (mm Al) Exposure Readings Exposure #1 Exposure #2 Exposure #3 Exposure #4 Mean Values Standard Deviations (SD) Coefficients of Variation (CV) Dosimetry Ion Chamber Reading mAs Energy & mAs Corrected Exposure Dose Conversion Factor (mrad/R) Computed Avg. Glandular Dose (mrad) Action Limit : mAs and Air Kerma Reproducibility: The maximum acceptable coefficient of variation for both mAs and air kerma in the reproducibility test is 0.05. Use of Test Results: If these conditions are not met, the source of the problem must be identified, and corrective action taken, within 30 days of the test date. Action Limit : Mean Glandular Dose: The mean glandular dose to the Standard breast must not exceed 3 mGy (0.3 rad) per view. Use of Test Results: If this condition is not met, the source of the problem must be identified, and corrective action, taken before further mammographic images are acquired using the Senographe Essential FFDM system that failed.
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4.2 cm
R
mAs
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Artifact Evaluation and Flat Field Uniformity
Type of Attenuator Thickness of Attenuator kVp setting mAs setting Image Receptor size Patient ID # Field size ……………………………. ……………………………. ……………………. …….. …………………………… …………………………… …………………………… ……………………………
Mo/Mo Focal Spot Magnification kVp mAs Artifact visible? Flat Field Non-Uniformity Equipment Artifact Detector Grid Attenuator Defect Other Description of Artifacts:
Mo/ Rh Rh/ Rh
Mo/Mo
Mo/Rh
Rh/Rh
Use of Test results: If an artifact or non-uniformity is present, and is expected to mimic or obscure clinical information, the source of the problem must be identified and corrective actions taken within 30 days of the test date.
25
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
kVp Accuracy and Reproducibility
kVp meter : Target /Filter Normal kVp setting Focal Spot mAs Measurement kVp values: 1 2 3 4 Mean kV p SD Additional kVp measurement 5 6 7 8 9 10 Recalculated Mean kV p SD Mean kVp - Normal kVp 0.05 x Normal kVp % Error Coefficient of Variation: (SD /Mean kVp) a Mo/Mo Mo/Rh Rh/Rh
26
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
平均管電壓峰值與顯示管電壓峰值之差異不應超過±5％。 管電壓再現性的變異係數必須≦ 0.02。
Beam Quality Assessment (Half-Value Layer Measurement)
Nominal kVp setting TARGET MATERIAL Filter mAs Exposure measurements (mR) No aluminum filtration, E(0a): 0.2 mm of added aluminum, E(2) 0.3 mm of added aluminum, E(3) 0.4 mm of added aluminum, E(4) 0.5 mm of added aluminum, E(5) No aluminum filtration, E(0b) Average E(0) = (E(0a)+ E(0b))/2 Calculated HVL (mm Al) Minimum allowed HVL: Maximum allowed HVL:
1. 半值層的下限值： (1) 測半值層時有放壓迫板： 在乳房攝影的管電壓範圍內(必須低於 50kVp)，有壓迫板存在時，所測量的 半值層需大於或等於下列的值： HVL≧ kVp/100 + 0.03(mmAl) (2) 測半值層時沒有放壓迫板： HVL≧ kVp/100(mmAl) 2. 半值層的上限值： HVL≦ kVp/100 + C(mmAl) 鉬/鉬組合時C= 0.12 mmAl 鉬/銠組合時C= 0.19
27
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
銠/銠組合時C= 0.22 鎢/銠組合時C= 0.30
Radiation Output
kVp 28 Breast Support 4.5cm above 28 Anode Mo Mo Filter Mo Mo SID (cm) EXP (mR) mAs Time Rate Kerma (sec) (mR/s) (mGy/s)
TIME: 3 SEC
Air Kerma Rate (mGy/s)= Exposure Rate (mR/s)x 0.00873 mGy/mR
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Mammographic Unit Assembly Evaluation
Site: Date: Equipment: Room ID: X-ray unit manufacturer Model : Pass/ Fail Free-standing unit is mechanically stable All moving parts move smoothly, without obstructions to motion All locks and detents work properly Image receptor holder assembly is free from vibrations Image receptor slides smoothly into holder assembly Image receptor is held securely by assembly in any orientation Compressed breast thickness scale accurate to ±0.5 cm, reproducible to ±2mm Patient or operator is not exposed to sharp or rough edges, or other hazards Operator technique control charts are posted Operator protected during exposure by adequate radiation shielding All indicator lights working properly Auto -decompression can be overridden to maintain compression (and status displayed) Manual emergency compression release can be activated in the event of a power failure Compress Force 15-20lb Collimator Light >160 Lux Note: Maximum Angle Display Tube Head to Left Tube Head to Right Pass/Fail
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Summary of Mammography Equipment Evaluation of Seno Advantage (Annual QC Tests) Test Results
1. Viewing Conditions Check and Setting Reference: Viewing Conditions Check and Setting Value Ambient Light Level Units
Pass
Value stable 5 lux over one minute
Fail
Requirement: The ambient light level must not exceed 20 lux. The measured value must be stable over one minute, with a tolerance of 5 lux over the measuring time with regards to the nominal lightingvalue. 2. Monitor Calibration Reference: Monitor Calibration Luminance Units: ………………………………….. Date of Baseline setting: BASELINE LUMINANCE Luminance Level L10 L60 L120 L180
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Date of QC Measurement: LUMINANCE MEASUREMENTS Left Monitor Pass/Fail Right Monitor Pass/Fail
Left Monitor
Right Monitor
附件八之二_ GE Senographe Essential (範例)
醫院： L255 Requirement:
檢查人員簽名：
覆核人員簽名：
The L10 luminance level of each monitor must be within 0.5 cd/m2 of the baseline measurement, The L60 luminance level of each monitor must be within 1 cd/m2 of the baseline measurement, The L120 luminance level of each monitor must be within 2 cd/m2 of the baseline measurement,
The L180 luminance level of each monitor must be within 7 cd/m2 of the baseline measurement, The L255 luminance level of each monitor must be within 10 cd/m2 of the baseline measurement. 3. Image Quality - SMPTE Pattern Reference: Image Quality – SMPTE Pattern Left Monitor Is the 0%-5% contrast visible? Is the 95%-100% contrast visible? Is each gray level step of the pattern distinguishable from the adjacent steps? Are alphanumeric characters sharply focused? Are line pair images in center distinguishable? Are line pair images in corners distinguishable? Right Monitor
Requirement: The 0%-5% contrast and the 95%-100% contrast shall be visible and each step from 0% to 100% shall be distinguishable from the adjacent ones. The alphanumeric characters shall appear sharply focused. The high-contrast line-pair patterns, except for the 1-pixel-on/1-pixel-off, vertical line-pair patterns, must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the line-pair patterns.
4. Analysis of the Seno Advantage Screen Uniformity Reference: Analysis of the Seno Advantage Screen Uniformity Pass Artifacts are not apparent or are not expected to mimic or obscure clinical information.
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Fail
附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Requirement: Artifact requirements must pass.
VIEWING CONDITIONS CHECK AND SETTING
Facility: Room: Date: ROOM DESCRIPTION Monitor position:
Room Lights:
Desk Lights:
Other: Ambient Light value: Room layout:
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Action Limit: The ambient light level must not exceed 20 lux. The measured value must be stable over one minute (with a tolerance of 5 lux over the measuring time with regards to the nominal lighting value). If the system fails the test, the source of the problem must be identified and corrective action taken, before any further mammographic images are reviewed or interpreted using the Seno Advantage.
MONITOR CALIBRATION
Facility: Luminance units: Luminance Level L10 L60 L120 L180 L255 Luminance Level L10 L60 L120 L180 L255 R1 R2 R3 R4 R5 Baseline Luminance L1 L2 L3 L4 L5 Baseline Luminance Date:
Date of Baseline setting: BASELINE LUMINANCE Luminance Level L10 L60 L120 L180
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Date of QC Measurement: LUMINANCE MEASUREMENTS Left Monitor Pass/Fail Right Monitor Pass/Fail
Left Monitor
Right Monitor
附件八之二_ GE Senographe Essential (範例)
醫院： L255 Action Limits:
檢查人員簽名：
覆核人員簽名：
The L10 luminance level of each monitor must be within 0.5 cd/m2 of the baseline measurement, The L60 luminance level of each monitor must be within 1 cd/m2 of the baseline measurement, The L120 luminance level of each monitor must be within 2 cd/m2 of the baseline measurement, The L180 luminance level of each monitor must be within 7 cd/m2 of the baseline measurement, The L255 luminance level of each monitor must be within 10 cd/m2 of the baseline measurement.
Image Quality –SMPTE Pattrern
Right Monitor (Pass/Fail) Is the 0%-5% contrast visible? Is the 95%-100% contrast visible? Is each gray level step of pattern? distinguishable from the adjacent steps? Are alphanumeric characters sharply focused? Are line pair images in center distinguishable? Are line pair images in corners distinguishable? Bleeding (gray levels degradation)? Other? Left Monitor (Pass/Fail)
Comments
Action Limit:
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附件八之二_ GE Senographe Essential (範例)
醫院： 檢查人員簽名： 覆核人員簽名： The SMPTE test pattern, low contrast targets and all gray level squares must be discernible. The alphanumeric characters shall appear sharply focussed. The high-contrast line-pair patterns representing 3-pixels-on/3-pixels-off and 2-pixels-on/2-pixels-off must be distinguishable at the center and the corners of the display for both the horizontal and vertical orientations of the bar patterns. The high-contrast line-pair patterns representing 1-pixel-on/1pixel-off must be distinguishable at the center and the corners of the display for the horizontal orientation of the bar patterns. If the system fails the test, the source of the problem must be identified, and corrective action taken, before any further mammographic images are reviewed or interpreted using the Seno Advantage.
Analysis of the Seno Advantage Screen Uniformity
Right Monitor (P/F) Visible Scratches Visible black poin Visible black point Visible non-uniformities Other Left Monitor (P/F)
Description of Artifacts:
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附件八之二_ GE Senographe Essential (範例)
醫院：
檢查人員簽名：
覆核人員簽名：
Action Limit: If an artifact or non uniformity is present and is expected to mimic or obscure clinical information, the source of the problem must be identified and corrective actions taken within 30 days of the test date.
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