REF # DOC #80XXX-00. STANDARD IMAGING, INC Deming Way Middleton, WI TEL TEL FAX

Transcription

1 REF STANDARD IMAGING, INC Deming Way Middleton, WI TEL TEL FAX Jul / Standard Imaging, Inc. DOC #80XXX-00 #

2 General Precautions WARNING: Follow manufacturer s recommended safety procedures for radioactive sources. CAUTION: Do not drop or mishandle the Lucy 3D QA Phantom components. Warnings and Cautions alert users to dangerous conditions that can occur if instructions in the manual are not obeyed. Warnings are conditions that can cause injury to the operator, while Cautions can cause damage to the equipment. CAUTION: Refer all servicing to qualified individuals. CAUTION: Proper use of this device depends on careful reading of all instructions and labels. 2

3 Table of Contents PAGE 3 Overview 4 Lucy 3D QA Phantom Setup 5 Lucy 3D QA Phantom Setup 8 Dosimetry QA Accessory Package Description 14 CT Imaging QA Accessory Package Description 19 MRI Imaging Accessory Package Description 24 Radiation Alignment Pointers 26 Additional Accessories Description 27 Additional Accessories Description 44 Getting Started Checklist 45 Position Verification and Isocenter Alignment Testing 46 Stereotactic Treatment Verification 49 Descriptions of Lucy 3D QA Phantom Alignment Bases 50 Maintenance 50 Bibliography 51 Parts and Accessories List 52 Features and Specifications 56 Service Policy 56 Customer Responsibility 57 Warranty Overview 3120 DEMING WAY MIDDLETON, WI USA The Lucy 3D QA Phantom is designed to perform comprehensive quality assurance tests for an entire stereotactic radiosurgery/ SRT procedure. It is compatible with CT, MR, and Angiographic imaging modalities. The phantom allows verification of treatment planning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verification is accomplished via components that accommodate ion chambers, film, MOS- FETs, TLDs and polymer gels. The Lucy 3D QA Phantom is a high precision modular phantom with tolerances of 0.1 mm in all critical areas, Figure 1. The sphere's design includes an 81 x 81 x 35 mm cavity in the upper Hemisphere A for placement of larger accessories. The lower Hemisphere C has 4 cylindrical cavities for placement of the imaging markers. A 85 x 85 x 10 mm cavity is located at the center of the sphere for smaller accessories. Imaging markers and accessories are always at known locations within the sphere's geometry. The cavities allow users to add testing capabilities, as they become needed or available, without having to replace or modify the phantom. The spherical phantom is typically mounted onto a Precision Leveling and Rotational Alignment Base or onto a manufacturer s stereotactic frame interface via a positioning assembly which permits 360 rotation in transverse, sagittal and coronal planes. 3

4 Overview Continued The Lucy 3D QA Phantom will assist in meeting the recommendations of TG 40 Comprehensive QA for Radiation Oncology, TG 42 Stereotactic Radiosurgery, TG 53 Quality Assurance for Clinical Radiotherapy Treatment Planning, and TG 66 Quality Assurance for Computer-tomography Simulators. For a detailed description of using Lucy 3D QA Phantom in a quality assurance program, please see "Lucy The Quality Assurance Phantom for Precision Radiation Therapy," Peter O'Brien, PhD and Ramani Mamaseshan, PhD; Lucy 3D QA Phantom Setup The Lucy 3D QA Phantom is mounted on the Precision Leveling and Rotational Alignment Base, REF 70021, or in the Stereotactic Frame Interface for the specific SRS treatment system to be evaluated. The phantom thus mounted can then be positioned within the imaging systems used to obtain images for the treatment planning software, CT, MRI and/or angiography. The phantom is imaged, the images are imported into the treatment planning system and a treatment is planned for the phantom. The phantom is then moved to the SRS treatment facility and treated. All imaging, planning and treatment steps are performed with the phantom the same as they would be for a real patient. In this manner the entire imaging and treatment chain can be evaluated. Whenever an image is transferred within the planning and delivery chain a potential for error exists. By examining images of the Lucy 3D QA Phantom after every image transfer step one can identify and address any errors that may occur. The locations for accessories within the Lucy 3D QA Phantom are shown in Figure 1. Figures 2 and 3 show how the Lucy 3D QA Phantom can be positioned in transverse, sagittal or coronal planes. This positioning can be accomplished with the SRS Frame Interfaces or with the Precision Leveling and Rotational Alignment Base. Lucy 3D QA Phantom Sphere includes (See Figure 1a): 1 Hemisphere locating pins (2) 2 Hemisphere screws (2) 3 Slotted screw plugs (2) 4 Hemisphere screw cavitys (2) 5 Short filler plug (1) 6 Short filler plug cavity (1) 7 Long filler screw cavity (1) 8 Marker cylinders (4) 9 Marker cylinder cavities (4) 10 Cavity 81 x 81 x 35 mm (1) 11 Cavity 81 x 81 x 10 mm (1) 12 Lucy Midchamber Plug 85 x 85 x 10 mm (1) 13 Filler plugs (4) Many options exist for SRS treatment planning and delivery. To perform tests specific to the system being evaluated, the user must select the accessories appropriate for the required tests. An example of a verification protocol is given in this manual section Stereotactic Treatment Verification. The user must be aware that tests for their specific RSR system will vary depending on the operation of their system. 4

5 Lucy 3D QA Phantom Setup C x A Figure 1a: Lucy 3D QA Phantom Sphere Features 5

6 Lucy 3D QA Phantom Setup Continued Figure 1b: Lucy 3D QA Phantom Sphere Dimensions 6

7 Lucy 3D QA Phantom Setup Continued Figure 2: Lucy 3D QA Phantom shown in transverse mounting position on standard base Figure 3: Lucy 3D QA Phantom shown in sagittal mounting position on standard base Standard Base Includes: 1 Standard Veritcal Support 2 Posterior Base 3 Counterbalance weight of lead 4 Anterior Base 5 Leveling Screws (3) Standard Clamp Includes: 6 Standard Neck 7 Screw Clamp Figure 4: Standard Base for the Lucy 3D QA Phantom, including Standard Clamp 7

8 Dosimetry QA Accessory Package Description This package includes the following accessories: Dosimetry Insert for Ion Chamber (multiple REF numbers) Dosimetry Film Cassette for three 2.5" x 2.5" films (REF 70084) Target / Treatment Verification Film Cassette (REF 70078) Dosimetry Insert for Ion Chamber (multiple REF numbers) This insert is used to verify a prescribed dose at the exact center of the Lucy 3D QA Phantom. The insert in made so the center of the ion chamber s active volume is positioned at the geometric center of the Lucy 3D QA Phantom. A clamp is provided to fix the chamber is position. The insert can be made to accommodate any of the small ion chambers typically used for small field dosimetry. The thickness of the insert is 10 mm so the overall thickness of the ion chamber and cable must be less than 10 mm. A single insert can only accommodate a specific model ion chamber, however multiple inserts for different ion chambers can be used interchangeably with one Lucy 3D QA Phantom. Figure 5: Dosimetry Insert for Ion Chamber, this example shows an Exradin A16 Ion Chamber Figure 6: Open Lucy 3D QA Phantom showing the Exradin A14SL or A16 Microchamber in position. Figure 7: Lucy 3D QA Phantom assembled with the ion chamber locked in position 8

9 Dosimetry QA Accessory Package Continued Figure 8: Schematic of Dosimetry Insert for Ion Chamber (Exradin A16 version) showing dimensions in mm 9

10 Dosimetry QA Accessory Package Continued Dosimetry Film Cassette for three 2.5" x 2.5" films (REF 70084) This cassette positions three films at the exact center of the Lucy 3D QA Phantom for film dosimetry measurements. The two films on either side of the central film are separated by 2.25 mm acrylic spacers. The cassette and spacers are made of clear acrylic. One spacer has ten 1 mm holes for orientation purposes. Figure 9: Dosimetry Film Cassette with the four spacers Figure 10a: Schematic of Dosimetry Film Cassette for three 2.5" x 2.5" films showing dimensions in mm 10

11 Dosimetry QA Accessory Package Continued A A SECTION A-A Figure 10b: Schematic of Dosimetry Film Cassette for three 2.5" x 2.5" films showing dimensions in mm 11

12 Dosimetry QA Accessory Package Continued Target/Treatment Verification Film Cassette (REF 70078) This cassette is made of black acrylic so it can accommodate radiochromic or conventional therapy film. It positions one 3 inch film at the exact center of the Lucy 3D QA Phantom. There are sharp markers in the Target/Treatment Verification Film Cassette which will produce four impressions forming a square on the film equidistant from the centre. The Target/Treatment Verification Film Cassette has a fifth marker, a position indicator. This fifth orientation marker produces an impression on the film and as well in the image. This marker will indicate the orientation of the Lucy 3D QA Phantom within the treatment planning system. Figure 11: Open cassette showing both sides of the cassette and a close up of the markers Figure 12: CT Scan of cassette 12

13 Dosimetry QA Accessory Package Continued A A SECTION A-A 4.85 B TITANIUM SHARP TIP 4.85 DETAIL B SCALE 8 : Figure 13: Schematic of Target/Treatment Verification Film Cassette showing dimensions in mm 13

14 CT Imaging QA Accessory Package Description This package includes the following accessories: CT Marker Cylinders, set of four (REF 70072) CT Volume Insert with 3 irregular known volumes (REF 70076) CT Grid Insert for spatial distortion (REF 70075) CT Marker Cylinders, set of Four (REF 70072) The CT Marker Cylinders and the MRI Marker Cylinders are used to evaluate the fusion function of treatment planning programs. The CT Marker Cylinders are acrylic cylinders 10 mm in diameter and 25 mm in length. One end of the cylinders has a red ring etched into the cylinder for orientation purposes. They fit into cavities in one hemisphere of the Lucy 3D QA Phantom which are spaced on a rectangle 60 mm center to center. Each markers contains five 2 mm diameter aluminum spheres which are spaced 5 mm center to center. Figure 14: Close-up of the four cylinders 2.00 Figure 15: CT Scan of cylinders A A SECTION A-A Figure 16a: Schematic of a CT Marker Cylinder showing dimensions in mm 14

15 CT Imaging QA Accessory Package Continued Figure 16b: Schematic of CT Marker Cylinder location within the Lucy Sphere showing dimensions in mm 15

16 CT Imaging QA Accessory Package Continued CT Volume Insert with 3 irregular known volumes (REF 70076) This insert has three irregularly shaped air volumes of 250, 750, and 1750 mm 3. The volume insert is used to ensure the integrity of the images as they are moved from one software program to another. Each time an image is transferred there exists the chance that an error may occur. Because the exact size and volume of the three geometries are known, any errors that occur can be quantified. Figure 17: CT Volume Insert Figure 18: CT Scan of the insert Area Volume Geometry mm 2500 mm 3 Geometry mm 7500 mm 3 Geometry mm mm 3 Figure 19: Table of the three geometries with the areas and volumes listed 16

17 CT Imaging QA Accessory Package Continued CT Grid Insert for spatial distortion (REF 70075) This insert is a two dimensional metallic grid specifically designed for checking image distortion and symmetry. Grid lines are visible at conventional settings for CT scanners. The grid wires are 0.5 mm aluminum and are spaced 5 mm apart. The wires originate at the center of the insert. Figure 20: CT Grid Insert Figure 21: CT Scan of insert 17

18 CT Imaging QA Accessory Package Continued 0.50 C L C L Figure 22: Schematic of CT Grid Insert for spatial distortion showing dimensions in mm 18

19 MRI Imaging Accessory Package Description This package includes the following accessories: MRI Marker Cylinders, set of four (REF 70074) MRI Volume Insert with 3 irregular known volumes (REF 70077) MRI Signal Generator (REF 70063) MRI Marker Cylinders, set of four (REF 70074) The CT Marker Cylinders and the MRI Marker Cylinders are used to evaluate the fusion function of treatment planning programs. The MRI Marker Cylinders are acrylic cylinders 10 mm in diameter and 25 mm in length. One end of the cylinders has a red ring etched into the cylinder for orientation purposes. They fit into cavities in one hemisphere of the Lucy 3D QA Phantom which are spaced on a rectangle 60 mm center to center. Each markers contains five 2 mm diameter spheres filled with mineral oil. The spheres are spaced 5 mm center to center. Figure 23: Close-up of the four cylinders A A SECTION A-A Figure 24: Schematic of a MRI Marker Cylinder showing dimensions in mm 19

20 MRI Imaging Accessory Package Continued MRI Volume Insert with 3 irregular known volumes (REF 70077) This insert has three irregularly shaped volumes which are filled with mineral oil. The areas are the same as that of the CT Volume Insert but the volumes are different because of the acrylic plates on each side to contain the mineral oil. The volume insert is used to ensure the integrity of the images as they are moved from one software program to another. Each time an image is transferred there exists the chance that an error may occur. Because the exact size and volume of the three geometries are known, any errors that occur can be quantified. Figure 25: MRI Volume Insert Area Volume Geometry mm 1700 mm 3 Geometry mm 5250 mm 3 Geometry mm mm 3 Figure 26: Table of the three geometries with the areas and volumes listed 20

21 MRI Imaging Accessory Package Continued Geometry 1 Geometry Geometry Figure 27: Schematic of MRI Volume Insert showing dimensions in mm 21

22 MRI Imaging Accessory Package Continued MRI Signal Generator (70063) The signal generator fits into the large cavity of the Lucy 3D QA Phantom and contains a manganese chloride solution. The volume of manganese is required to produce enough MRI signal strength to image the MRI Marker Cylinders and the MRI Volume Insert. Figure 28: MRI Signal Generator Figure 29: MRI image of cylinders, volume insert, and signal generator 22

23 MRI Imaging Accessory Package Continued A A SECTION A-A Figure 30: Schematic of MRI Signal Generator showing dimensions in mm 23

24 Radiation Alignment Pointers The Radiation Alignment Pointer (REF 70079) attaches to the Precision Leveling and Rotational Alignment Base (REF 70021) for secure positioning. Two alignment pointers are provided, one with a 5 mm tungsten sphere tip and one with a 3 mm aluminum sphere tip. The spheres are used for optical alignment and can also be used for radiation isocenter alignment when used with radiographic film. Figure 31: Close up of the pointer tips Figure 32: Pointer on base 24

25 Radiation Alignment Pointers Continued Figure 33: Schematic of Radiation Alignment Pointer 25

26 Additional Accessories Description IGRT Localization & Angiography Marker Cylinders, set of four (REF 70073) IGRT Localization & Angiography Marker Cylinders when used with the CT Marker Cylinders and the MRI Marker Cylinders are used to evaluate the fusion function of treatment planning programs. The IGRT kv and X-Ray Angiography Marker Cylinders are acrylic cylinders 10 mm in diameter and 25 mm in length. One end of the cylinders has a red ring etched into the cylinder for orientation purposes. They fit into cavities in one hemisphere of the Lucy 3D QA Phantom which are spaced on a rectangle 60 mm center to center. Each markers contains one 2 mm diameter lead sphere. The center of the sphere is placed 3 mm below the top of the acrylic cylinder. Figure 34: Close-up of the four cylinders A A SECTION A-A Figure 35a: Schematic of an IGRT Localization & Angiography Marker Cylinder showing dimensions in mm 26

27 Additional Accessories Description Figure 35b: Schematic of IGRT Localization & Angiography Marker Cylinder location withing the Lucy Sphere showing dimensions in mm 27

28 Additional Accessories Continued Dosimetry Film Cassette for Three 3.0" x 3.0" Films (REF 70091) This cassette positions three films at the exact center of the Lucy 3D QA Phantom for film dosimetry measurements. The two films on either side of the central film are separated by 2.25 mm acrylic spacers. The cassette and spacers are made of clear acrylic. One spacer has ten 1 mm holes for orientation purposes. Figure 36: Cassette with the four spacers A Figure 37a: Schematic of Dosimetry Film Cassette for Three 3.0" x 3.0" Films showing dimensions in mm 28

29 Additional Accessories Continued A A SECTION A-A Figure 37b: Schematic of Dosimetry Film Cassette for Three 3.0" x 3.0" Films showing dimensions in mm 29

30 Additional Accessories Continued Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Films (REF 70089) This cassette positions thirteen films in the large void in one hemisphere of the Lucy 3D QA Phantom for film dosimetry measurements. The cassette and spacers are made of clear acrylic. One spacer has ten 1 mm holes for orientation purposes. Figure 38: Cassette with the fourteen spacers A Figure 39a: Schematic Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Films showing dimensions in mm

31 Additional Accessories Continued A A SECTION A-A Figure 39b: Schematic Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Films showing dimensions in mm 31

32 Additional Accessories Continued Multiple Target Shapes Insert Kit (REF 76013) This insert provides complex geometric targets of known dimensions and volumes. Use this insert to assess if your treatment planning system can accurately re-create the target shapes. The kit includes the Dosimetry Film Cassette for Thirteen 2.5 x 2.5 films which can be used separately to verify dosimetric delivery. The insert contains two core target shapes with corresponding avoidance structures which can be used to test complex dose delivery plans and a relative dose shape against objects of known dimensions. Figure 40: Multiple Target Shapes Insert Kit R 3.18 mm 7.11 mm 2.11 mm Ø 6.0 mm Ø 20.0 mm mm Ø 6.0 mm Ø 10.0 mm Ø 20.0 mm Figure 42: Core Target Shape Dimensions (not drawn to scale) 32

33 Additional Accessories Continued A A SECTION A-A Figure 43: Multiple Target Shapes Insert Kit Schematic 33

34 Additional Accessories Continued Dosimetry Insert for MOSFET Detectors (REF 70058) This dosimetry insert positions 15 MOSFET detectors in the central plane of the Lucy 3D QA Phantom. One detector is positioned at the exact center of the phantom. The size of the cavities are 2.5 x 8 x 1 mm. Figure 44: Dosimetry Insert for MOSFET Detectors Figure 45: CT Scan of Insert 34

35 Additional Accessories Continued Figure 46: Schematic of Dosimetry Insert for MOSFET Detectors showing dimensions in mm 35

36 Additional Accessories Continued Dosimetry Insert for 3mm TLD Detectors (REF 70059) This dosimetry insert allows the positioning of up to 49 TLDs in the central plane of the Lucy 3D QA Phantom. One TLD is positioned at the exact center of the phantom. The size of the cavities are 3.4 x 3.4 x 1 mm. Figure 47: Dosimetry Insert for TLD Detectors Figure 48: CT Scan of insert 36

37 Additional Accessories Continued A DETAIL A SCALE 5 : 1 Figure 49: Schematic of Dosimetry Insert for TLD Detectors showing dimensions in mm 37

38 Additional Accessories Continued Dosimetry Insert for 1mm TLD Detectors (REF 70106) This dosimetry insert allows the positioning of up to 85 TLDs in the central plane of the Lucy 3D QA Phantom. One TLD is positioned at the exact center of the phantom. The size of the cavities are 1.5 x 1.5 x 1 mm A Figure 50a: Schematic of Dosimetry Insert for TLD Detectors showing dimensions in mm 38

39 Additional Accessories Continued DETAIL A SCALE 6 : Figure 50b: Schematic of Dosimetry Insert for TLD Detectors showing dimensions in mm 39

40 Additional Accessories Continued Electron Density QA Insert (REF 70104) This insert provides four independent targets plus the surrounding material made of different CT electron densities, and is designed to fit inside the existing cavity in the Lucy 3D QA Phantom. The insert measures 85 mm x 85 mm x 10 mm, and provided targets include Air, Adipose (nominal CT value: -60), Trabecular Bone (nominal CT value: 220) and Cortical Bone (nominal CT value: 850). The surrounding material is Blue Water (nominal CT value: 70). # Material Density [g/cm3] Nom. CT Value [HU] Electron Density [per cc x 1023] 1 Adipose Trabecular Bone Cortical Bone Air (no insert) 5 Blue Water Figure 51: Electron Density QA Insert ADIPOSE INSERT CORTICAL BONE INSERT TRABECULAR BONE INSERT NO INSERT - REMAINS EMPTY REFERENCE HOLE Figure 52: Electron Density QA Insert 40

41 Additional Accessories Continued Ø Figure 53: Schematic of Electron Density QA Insert showing dimensions in mm 41

42 Additional Accessories Continued MRI Isocentric Volume Insert (REF 70107) Developed in cooperation with Sam Hancock, Ph.D. of Southeast Missouri Hospital this insert has a single isocentrically placed irregularly shaped volume which is filled with mineral oil. The insert allows for complete end-to-end QA of the complete radiosurgery process. Perform tests including those for CT and MR, image fusion, treatment planning and treatment delivery all with a single system. Because the exact size and volume of the target is known, the integrity of images of the insert can be checked for accuracy when the files are transferred from one software to another. Image fusion can be tested between different imaging modalities also. A plan can be created in the treatment planning computer to treat the volume and dosimetry tests utilizing the Dosimetry Insert for Ion Chamber (multiple REF numbers) and Target/Treatment Verification Film Cassette (REF 70078) can be completed. A PowerPoint presentation by Dr. Hancock outlining the use of this insert is available upon request from Standard Imaging. Figure 54: MRI Isocentric Volume Insert 42

43 Additional Accessories Continued Figure 55: Schematic of MRI Isocentric Volume Insert Area Volume Geometry mm 890 mm 3 Geometry mm 890 mm 3 Geometry mm 5250 mm 3 43

44 Getting Started Checklist Before you begin, review the following checklist: 1. When obtaining Dosimetric QA Measurements using: Ion Chambers: Confirm you have the correct Dosimetry Insert for Ion Chamber Fig. 1, for the ion chamber you will be using. Test the ion chamber with the Dosimetry Insert for Ion Chamber to be certain it fits. Film: Confirm you have film available for the Dosimetry Film Cassette you will be using; four Dosimetry Film Cassettes Fig. 2, are available. Confirm film pieces have been cut to the proper size. Decide how the film density will be related to dose using a scanning system or visual inspection. If using film that needs to be run through an automatic processor, determine how this will be done. Typically, the small piece of film is taped to the end of a large piece of film and then both are run through the processor. 2. When obtaining MRI Imaging QA Measurements: The MRI Signal Generator Fig. 3, must be placed in the Lucy 3D QA Phantom when the MRI Marker Cylinders Fig. 4, and MRI Volume Insert Fig. 5, are imaged. 3. Allocation of time: Ensure that adequate time is scheduled on imaging and treatment equipment for completing a Lucy 3D QA Phantom imaging and treatment session. Initially, several hours may be required. 44

45 Position Verification and Isocenter Alignment Testing The Lucy 3D QA Phantom includes the Lucy Midchamber Plug with 4 mm Brass Ball (REF 50209) which can be utilized as a position verification and isocenter alignment test object. Position Verification Setting up the Lucy 3D QA Phantom and securing the interface to your specific stereotactic frame can be a complicated process. If done correctly the absolute center of the Lucy 3D QA Phantom will be automatically aligned to the isocenter of your system which is required so that measurements made with Lucy will be accurate. Using the Lucy Midchamber Plug a simple test can be performed to verify the setup. 1. Install the Lucy 3D QA Phantom and frame interface into the patient treatment frame. Level the phantom and ensure it is parallel to the CT or MRI scanning couch. 2. Scan the phantom and the patient treatment frame using a series of CT or MRI slices. Ensure a complete series of images is acquired including the entire phantom. Ensure the fiducial markers of the patient treatment frame are visible on the scanned images. 3. Record the phantom orientation for any subsequent images that may be obtained, such as, sets of axial, sagittal and coronal images. 4. Import the CT and/or MRI images into the treatment planning software. 5. Using the fiducial markers of the patient treatment frame locate the machine isocenter of your treatment field. 6. Verify that the 4 mm radio-opaque brass ball of the Midchamber Plug is aligned to the machine isocenter. End-to-End Hidden Target Test Utilizing the Lucy MidChamber Plug a complete end-to-end test that mimics a patient treatment can be accomplished. 1. Install the Lucy 3D QA Phantom and frame interface into the patient treatment frame. Level the phantom and ensure it is parallel to the CT or MRI scanning couch. 2. Scan the phantom and the patient treatment frame using a series of CT or MRI slices. Ensure a complete series of images is acquired including the entire phantom. Ensure the fiducial markers of the patient treatment frame are visible on the scanned images. 3. Record the phantom orientation for any subsequent images that may be obtained, such as, sets of axial, sagittal and coronal images. 4. Import the CT and/or MRI images into the treatment planning software. 5. Using the radio-opaque marker as a treatment volume construct a simple treatment plan. 6. Utilize positioning tools and/or methods to set up the phantom in the treatment room. 7. Irradiate the phantom and acquire images of the treatment fields utilizing the MV imaging system or film. 8. Evaluate the position of the radioopaque marker in relation to the treatment field in the obtained images. 45

46 Stereotactic Treatment Verification Getting Started 1. Secure the Lucy 3D QA Phantom to the stereotactic frame. Level the phantom and ensure it is parallel to the CT or MRI scanning couch. Ensure the axis of the test insert being used is parallel to plane of the CT or MRI slices. 2. Scan the phantom and the patient treatment frame using a series of CT or MRI slices. Ensure a complete series of images is acquired including the entire phantom. Ensure the fiducial markers of the patient treatment frame are visible on scanned images. Note: The MRI Volume Chamber Fig. 5, may be used for either CT or MRI scans. The CT Volume Chamber Fig. 6, is only used for CT scanning. The CT Marker Cylinders Fig. 7, and MRI Marker Cylinders Fig. 4, are used to evaluate the fusion function of treatment planning programs. If both CT and MRI scans are obtained, place the CT Marker Cylinders in the Lucy 3D QA Phantom during the CT scanning and the MRI Marker Cylinders in Lucy 3D QA Phantom during the MRI Scanning. Note: The MRI Signal Generator must be placed in the Lucy 3D QA Phantom when the MRI Marker Cylinders and MRI Volume Insert are imaged. 3. Record the phantom orientation for any subsequent images that may be obtained, such as, sets of axial, sagittal, and coronal images. 4. Import the CT and/or MRI images into the treatment planning software. 5. Construct a treatment plan using the imported CT and/or MRI images. The plan may be done for one of the volume inserts or for any target created by the user. Ensure the target is outlined and visible on the hard copy of the plan if required. Using your treatment planning software, calculate the volume of the 3 targets in the volume inserts. Compare the volumes calculated within the treatment planning system to the known target volumes to confirm the correct volumes have been established by the treatment planning software1. Note: Any imaging discrepancy should be noted for further action. 'Fusion' QA Process 6. If both CT and MRI scans are imported into the treatment planning software, the images can be fused using the tools within the treatment planning software. The accuracy of the fused images can be evaluated by comparing them to the known measurements described in the Lucy 3D QA Phantom specifications. 'Distance Measurements' QA Process 7. Exact manufacturing tolerances allow you to compare the Lucy 3D QA Phantom distance measurements to the distance measurements of images in treatment planning software2. Distance measurements should be evaluated at every step of the imaging process as errors may occur whenever images are transferred from one program to another. The steps after which distance accuracy should be evaluated include acquisition of CT and MRI images, after transfer of the CT and MRI images to the treatment planning software, after the fusion and planning steps, and after saving and recalling plans from the record and verify software program. Distance measurements should also be verified in all planes used for treatment planning, transverse, sagittal, and coronal. NOTE: Any discrepancy should be noted for further action. 46

47 Stereotactic Treatment Verification Continued To perform distance measurements, first identify the isocenter(s) used in the plan relative to the coordinate system of the frame. Be sure the isocenter(s) are visible on the hardcopy printout of the plan. This hard copy will be used later to compare isocenter(s) and isodose curves to the actual dose measured by film dosimetry. Plans should be done in a transverse slice corresponding to the plane at the center of the target chamber and also in a perpendicular sagittal and/or coronal plane containing one of the isocenters. Mark the isocenter(s) coordinates on the frame plates to enable treatment set-up, Step 9. This description is specifically for the case where laser set-up to marked points is used. For other techniques the actual set-up will be different. 'Dosimetry Measurements' QA Setup Process 8. Insert the Target/Treatment Verification Film Cassette Fig. 8, in the Lucy 3D QA Phantom. The cassette can accept commercially available radiochromic or conventional therapy film; if light-sensitive film is used, test the film cassette to ensure it is light proof. There are sharp markers in the Target/Treatment Verification Film Cassette which produce four impressions forming a square on the film equidistant from the center. The Target/Treatment Verification Film Cassette has a fifth position indicator marker. This fifth orientation marker produces an impression on the film and indicates the orientation of the Lucy 3D QA Phantom within the treatment planning system. 9. Place the Lucy 3D QA Phantom on the treatment couch using the frame and the marked coordinates to identify the treatment isocenters. Visually ensure the orientation of the Lucy 3D QA Phantom is identical with the orientation used during CT and MRI scanning. 'Dosimetry Measurements' Treatment Process 10. Select the prescription dose, which is compatible with the sensitivity of thefilm, and deliver the prescription dose to the Target/Treatment Verification Film Cassette within the Lucy 3D QA Phantom. Then treat the Lucy 3D QA Phantom with the selected prescription dose. 11. Process and handle the exposed film as needed depending on the type of film being used. 12. Locate the center of the film using the four marks that are on the film located towards each corner of the square. The fifth mark on the film will indicate the orientation of the Lucy 3D QA Phantom. 'Planned Dose to Delivered Dose' Comparison Process 13. To compare the delivered radiation pattern with the planned dose distribution, the film density pattern must be registered with the planned dose distribution3. To compare the planned dose to the delivered dose, an isodose distribution must be produced from the film and overlaid on the treatment plan isodose distribution. (Use the tools available within the treatment planning system to compare the isodose distribution produced on the film to the planned isodose distribution or visually compare the developed film to the printed hard copy of the treatment plan.) Note: Any discrepancy should be noted for further action. 47

48 Stereotactic Treatment Verification Continued 14. In a similar manner, the Dosimetry Insert for Ion Chamber may be used to confirm prescribed dose at the exact center of the Lucy 3D QA Phantom. The TLD Dosimetry Cassette and the MOSFET Dosimetry Cassette may also be used for dosimetry tests. 48

49 Descriptions of Lucy 3D QA Phantom Alignment Bases Standard Precision Leveling and Rotational Alignment Base - REF The original standard alignment base (Figure 4) provides great functionality for many applications where a specific stereotactic frame is not desired to be mounted in the testing scenarios, including: 1. The base is free-standing on flat surfaces with three leveling feet to align or level 2. The spherical phantom extends over the base anterior, surrounded by air, permitting a large range of scanning or radation delivery approaches 3. The spherical phantom is repeatedly locked in the same position by way of a clampling screw ("neck") assembly 4. The spherical phantom may be mounted in a coronal, sagittal or transverse mounting position, creating repeatable coronal, sagittal and transverse planes of simulation 5. The spherical phantom may be rotated and locked to any of 360 degree positions, in either coronal or transverse mounting, and repeated over time or place. (General Electric) MRI Headcoil Base - MRGE-B NOTE: If the Lucy 3D QA Phantom is to be imaged in the body coil, the Simple Leveling Base (REF 70038) may fit on the couch surface of some MR models. In either case, the Lucy 3D QA Phantom is fitted with the MRI accessories (REF 70074, REF 70077, and REF 70063, for example) to provide self-generating signal, and the MR fiducial points and target volumes. Stereoadapter 5000 Stereotactic Frame Supports (used with and GEMRI-A) - REF The Lucy Precision Base (REF 50003) and GEMRI-A alignment bases are used for the Sandstrom Stereoadapter 5000, with the addition of delrin optional adapters (REF 70101) which stabilize the position of the Stereoadapter frame. Load-Bearing Stereoadapter Frame Support (used with 70021) - REF Includes delrin adapter (REF 70101) and an Anterior Extended Base to support vertex of the Sandstrom Stereoadapter. For applications requiring rigid stability of system and where additional weighted surgical accessories may be mounted on vertex of stereoadapter, i.e. biopsy targeting kit, IGS tracking devices, etc. This supportive base performs the same functions as the Standard Precision Leveling and Rotational Alignment Base (REF 70021), with the exception of point 1. The concase plastic base cradles in the headcoil to permit typical T1 or T2 -weighted brain protocols to be run within the headcoil, simulating actual patient conditions. The supportive base is not compatible with large body coils. 49

50 Maintenance Exterior cleaning of the device can be done with a soft brush and a cloth. Gently brush all surfaces to remove dirt and dust. Remove any remaining dirt with a cloth slightly dampened with a solution of mild detergent and water or a liquid disinfecting agent. There are no user serviceable parts on the Lucy 3D QA Phantom. Calibration of the Lucy 3D QA Phantom is not required. If assistance is desired in the proper disposal of this product (including accessories and components), after its useful life, please return to Standard Imaging. Bibliography 1. R. Ramasesham, M. Heydarian, Comprehensive quality assurance for stereotactic radiosurgery treatments, Phys. Med. Biol. 48(2003) N119-N R. Ramani, et.al., A QA phantom for dynamic stereotactic radiosurgery: Quantitative measurements, Med. Phys. 22(8), August R. Ramani, et.al., The use of Radiochromic film in treatment verification of dynamic stereotactic radiosurgery, Med. Phys. 21(3), AAPM Radiation Therapy Committee TG53: Quality assurance for clinical radiotherapy treatment planning, Med. Phys. 25(10), October AAPM Radiation Therapy Committee TG66: Quality assurance for computed-tomography simulators and the computed-tomography-simulation process, Med. Phys. 30(10), October

51 Parts and Accessories List REF Description Lucy 3D QA Phantom - Spherical Lucite Phantom Precision Leveling and Rotational Alignment Base Blank Filler Plug (HEMI-C) Lucy Midchamber Plug with 4mm Brass Ball Stereotactic Frame Interfaces Leksell G Gamma Knife / 3-D Line Stereotactic Frame Interface BrainLAB Stereotactic Frame Interface Radionics / CRW/BRW Stereotactic Frame Interface Varian / CRW/BRW Stereotactic Frame Interface Sandstrom Stereo-Adapter Stereotactic Frame Interface Lucy Dosimetry QA Accessory Package - One of the following chamber inserts: C03 - Dosimetry Insert for Model A1SL Exradin Ion Chamber, cc C04 - Dosimetry Insert for Model A14SL Exradin Ion Chamber, cc C09 - Dosimetry Insert for Model A16 Exradin Ion Chamber, cc C12 - Dosimetry Insert for Wellhofer-CC13 Ion Chamber C13 - Dosimetry Insert for Wellhofer-CC04 Ion Chamber C14 - Dosimetry Insert for Wellhofer-CC01 Ion Chamber, 0.01 cc C15 - Dosimetry Insert for PTW Ion Chamber C16 - Dosimetry Insert for PTW Ion Chamber, cc C17 - Dosimetry Insert for PTW Semiflex, 0.3cc Ion Chamber C18 - Dosimetry Insert for PTW (T31006) Ion Chamber C21 - Dosimetry Insert for PTW Pinpoint 3D Ion Chamber C22 - Dosimetry Insert for PTW Ion Chamber C23 - Dosimetry Insert for PTW Pinpoint, 0.03cc Ion Chamber C27 - Dosimetry Insert for Model A18 Exradin Ion Chamber, cc C28 - Dosimetry Insert for Scanditronix SFD DEB050 Ion Chamber, 4.25 mm C29 - Dosimetry Insert for Scanditronix SFD Ion Chamber, 5.11 mm Dosimetry Film Cassette for four 2.5 x 2.5 inch Films Target / Treatment Verification Film Cassette Lucy CT Imaging QA Accessory Package - CT Marker Cylinders, set of four - CT Volume Insert with 3 irregular known volumes - CT Grid Insert for spatial distortion Lucy MRI Imaging QA Accessory Package - MRI Marker Cylinders, set of four - MRI Volume Chamber with 3 irregular known volumes - MRI Signal Generator Radiation Alignment Pointers (Includes 5 mm tungsten sphere tip and 3 mm aluminum sphere tip) Additional Accessories IGRT Localization & Angiography Marker Cylinders, set of four Dosimetry Film Cassette for four 2.5" x 2.5" films Dosimetry Film Cassette for fourteen 2.5" x 2.5" films Dosimetry Film Cassette for four 3.0" x 3.0" films MOSFET Dosimetry Cassette Dosimetry Insert for 3mm TLD Detectors Dosimetry Insert for 1mm TLD Detectors Electron Density QA Insert Multiple Target Shapes Insert Kit MRI Isocentric Volume Insert Blank Midchamber Plug (HEMI-A) MAX 4000 Electrometer Exradin A16 MicroChamber Exradin A14SL MicroChamber Exradin A1 Thimble Ion Chamber Exradin A18 Thimble Ion Chamber 51 Leksell Gamma Knife is a registered trademark of Elekta Instruments, Inc.

52 Features and Specifications Lucy 3D QA Phantom Blank Filler Plug (HEMI-C) Blank Filler Plug (HEMI-A) Lucy Midchamber Plug with 4mm Brass Ball Accessory Port for Ionization Chambers Precision Leveling and Rotational Alignment Base Height Depth Width Weight Acrylic Sphere 140 mm (5.51 in) diameter 81 x 81 x 35 mm (3.19 x 3.19 x 1.38 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 8 mm (.31 in) diameter 30 cm (11.81 in) 23 cm (9.06 in) 20 cm (7.87 in) 3.4 kg (7.5 lbs) Dosimetry QA Accessories Dosimetry Insert for Ion Chamber Dosimetry Film Cassette for four 2.5" x 2.5" films Target/Treatment Verification - Film Cassette - Four Titanium Fiducial Markers - One Titanium Fiducial Marker for Orientation Dosimetry Film Cassette for Four 3.0" x 3.0" films Dosimetry Film Cassette for Fourteen 2.5" x 2.5" films 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 60 mm (2.36 in) square pattern 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 35 mm (3.35 x 3.35 x 1.38 in) CT QA Accessories CT Marker Cylinders, set of four - Five 2.0 mm Aluminum Spheres per cylinder CT Volume Insert with 3 irregular known volumes - Geometry One - Geometry Two - Geometry Three CT Grid Insert for spatial distortion MRI QA Accessories MRI Marker Cylinders, set of four - Five 2.0 mm mineral oil spheres per cylinder MRI Volume Insert with three known Geometries - Geometry One - Geometry Two - Geometry Three MRI Signal Generator - Cavity Filled with Manganese Chloride Imaging QA Accessories IGRT Localization & Angiography Marker Cylinders, set of four - One 2.0 mm Lead Sphere in each cylinder 10 mm (.39 in) length, 25 mm (.98 in) diameter 5 mm (.197 in) center-to-center 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) Area 250 mm, Volume 2500 mm 3 Area 750 mm, Volume 7500 mm 3 Area 1750 mm, Volume mm 3 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 0.5 mm (.02 in) aluminum wire spaced 5 mm (.197 in) apart 10 mm (.39 in) length, 25 mm (.98 in) diameter 5 mm (.197 in) center-to-center 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) Area 250 mm, Volume 1700 mm 3 Area 750 mm, Volume 5250 mm 3 Area 1750 mm, Volume mm 3 85 x 85 x 35 mm (3.35 x 3.35 x 1.38 in) 10 mm (.39 in) length, 25 mm (.98 in) diameter Radiation Alignment Pointer Includes 3 mm Optical Alignment Tip and Radiation 5 mm Alignment Tip 52 Specifications are subject to change without notice.

53 Features and Specifications Continued MOSFET Dosimetry Cassette Cassette with 15 cavities 2.5 x 8 x 1 mm to accommodate MOSFET Diodes Dosimetry Insert for 3mm TLD Detectors Cassette with 49 cavities 3.4 x 3.4 x 1 mm to accommodate TLDs Dosimetry Insert for 1mm TLD Detectors Cassette with 78 cavities 1.5 x 1.5 x 1 mm to accommodate TLDs Multiple Target Shapes Insert Kit Cassette with 49 cavities 3.4 x 3.4 x 1 mm to accommodate TLDs Electron Density QA Insert Insert with 4 different targets made of materials that have different CT densities MRI Isocentric Volume Insert Insert with isocentrically placed irregularly shaped volume 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 63 x 63 x 20 mm (2.5 x 2.5 x.78 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) 85 x 85 x 10 mm (3.35 x 3.35 x.39 in) Standards 93/42/EEC See for applicable tech notes. Specifications are subject to change without notice. 53

54 Notes 54

55 Service Policy Customer Responsibility If service, including recalibration, is required, please contact Standard Imaging s Customer Service department by phone or prior to shipping the product. Standard Imaging s Customer Service and Technical Service staff will attempt to address the product issue via phone or . If unable to address the issue, a return material authorization (RMA) number will be issued. With the RMA number, the product can be returned to Standard Imaging. It is the responsibility of the customer to properly package, insure and ship the product, with the RMA number clearly identified on the outside of the package. The customer must immediately file a claim with their carrier for any shipping damage or lost shipments. Return shipping and insurance is to be pre-paid or billed to the customer, and the customer may request a specific shipper. Items found to be out of warranty are subject to a minimum service fee of 1 hour labor (excluding recalibrations) for diagnostic efforts and require a purchase order (PO) before service is performed. With concurrence from customer, the product may be replaced if it is unserviceable or if the required service is cost prohibitive. Products incurring service charges may be held for payment. Standard Imaging does not provide loaner products. See the Standard Imaging Warranty and Customer Responsibility for additional information. Serialization Information Standard Imaging products that are serialized contain coded logic in the serial number which indicates the product, day and year of manufacture, and a sequential unit number for identification: A YY DDD X This product and its components will perform properly and reliably only when operated and maintained in accordance with the instructions contained in this manual and accompanying labels. A defective device should not be used. Parts which may be broken or missing or are clearly worn, distorted or contaminated should be replaced immediately with genuine replacement parts manufactured by or made available from Standard Imaging Inc. CAUTION: Federal law in the U.S.A. and Canadian law restrict the sale, distribution, or use of this product to, by, or on the order of a licensed medical practitioner. The use of this product should be restricted to the supervision of a qualified medical physicist. Measurement of high activity radioactive sources is potentially hazardous and should be performed by qualified personnel. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from Standard Imaging Inc. prior to such repair or replacement. If this product is in need of repair, it should not be used until all repairs have been made and the product is functioning properly and ready for use. After repair, the product may need to be calibrated. The owner of this product has sole responsibility for any malfunction resulting from abuse, improper use or maintenance, or repair by anyone other than Standard Imaging Inc. The information in this manual is subject to change without notice. No part of this manual may be copied or reproduced in any form or by any means without prior written consent of Standard Imaging Inc. A YY DDD X Unique product ID Last two digits of the year (e.g = 99, 2000 = 00) Day of the year (1< DDD < 365) Unique unit ID Number (1 < X < 9) 55

56 Warranty Standard Imaging, Inc. sells this product under the warranty herein set forth. The warranty is extended only to the buyer purchasing the product directly from Standard Imaging, Inc. or as a new product from an authorized dealer or distributor of Standard Imaging, Inc. For a period provided in the table below from the date of original delivery to the purchaser or a distributor, this Standard Imaging, Inc. product, provided in the table is warranted against functional defects in design, materials and workmanship, provided it is properly operated under conditions of normal use, and that repairs and replacements are made in accordance herewith. The foregoing warranty shall not apply to normal wear and tear, or if the product has been altered, disassembled or repaired other than by Standard Imaging, Inc. or if the product has been subject to abuse, misuse, negligence or accident. Product Standard Imaging Ionization Chambers Standard Imaging Well Chambers Standard Imaging Electrometers Standard Imaging BeamChecker Products Standard Imaging Software Products All Other Standard Imaging Products Standard Imaging Custom Products Standard Imaging Remanufactured Products Standard Imaging Custom Select Products Consumables Serviced Product Resale Products ADCL Product Calibration (Standard Imaging uses the UW-ADCL for recalibrations required under warranty) Warranty Period 2 years 2 years 5 years 2 years 1 year 1 year 1 year 180 days 90 days 90 days 90 days As defined by the Original Equipment Manufacturer 0-90 days = 100% of ADCL Calibration Costs days = 75% of ADCL Calibration Costs days = 50% of ADCL Calibration Costs days = 25% of ADCL Calibration Costs (days from date of shipment to customer) Standard Imaging s sole and exclusive obligation and the purchaser s sole and exclusive remedy under the above warranties are, at Standard Imaging s option, limited to repairing, replacing free of charge or revising labeling and manual content on, a product: (1) which contains a defect covered by the above warranties; (2) which are reported to Standard Imaging, Inc. not later than seven (7) days after the expiration date of the warranty period in the table; (3) which are returned to Standard Imaging, Inc. promptly after discovery of the defect; and (4) which are found to be defective upon examination by Standard Imaging Inc. Transportation related charges, (including, but not limited to shipping, customs, tariffs, taxes, and brokerage fees) to Standard Imaging are the buyer s responsibility. This warranty extends to every part of the product except consumables (fuses, batteries, or glass breakage). Standard Imaging, Inc. shall not be otherwise liable for any damages, including but not limited to, incidental damages, consequential damages, or special damages. Repaired or replaced products are warranted for the balance of the original warranty period, or at least 90 days. This warranty is in lieu of all other warranties, express or implied, whether statutory or otherwise, including any implied warranty of fitness for a particular purpose. In no event shall Standard Imaging, Inc. be liable for any incidental or consequential damages resulting from the use, misuse or abuse of the product or caused by any defect, failure or malfunction of the product, whether a claim of such damages is based upon the warranty, contract, negligence, or otherwise. This warranty represents the current standard warranty of Standard Imaging, Inc. Please refer to the labeling or instruction manual of your Standard Imaging, Inc. product or the Standard Imaging, Inc. web page for any warranty conditions unique to the product. 56