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REF 91210 DOC #80XXX-00 STANDARD IMAGING, INC. 3120 Deming Way Middleton, WI 53562-1461 TEL 800.261.4446 TEL 608.831.0025 FAX 608.831.2202 Jul / 2010 ©2010 Standard Imaging, Inc. DOC #80542-06 WWW. .COM

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Page 1: WWW. · QA Phantom in a quality assurance program, please see "Lucy The Quality Assurance Phantom for Precision Radiation Therapy," Peter O'Brien, PhD and Ramani Mamase-shan, PhD;

REF 91210

DOC #80XXX-00

STANDARD IMAGING, INC.3120 Deming WayMiddleton, WI 53562-1461

TEL 800.261.4446TEL 608.831.0025FAX 608.831.2202

Jul / 2010 ©2010 Standard Imaging, Inc.

DOC #80542-06

WWW. .COM

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General Precautions

WARNING:Follow manufacturer’s recom-mended safety procedures for radioactive sources.

CAUTION:Do not drop or mishandle the Lucy 3D QA Phantom com-ponents.

CAUTION:Refer all servicing to quali-fied individuals.

CAUTION:Proper use of this device de-pends on careful reading of all instructions and labels.

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.

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3 Overview4 Lucy 3D QA Phantom Setup5 Lucy 3D QA Phantom Setup8 Dosimetry QA Accessory

Package Description14 CT Imaging QA Accessory

Package Description19 MRI Imaging Accessory

Package Description24 Radiation Alignment Pointers26 Additional Accessories Description27 Additional Accessories Description44 Getting Started Checklist45 PositionVerificationand

Isocenter Alignment Testing46 StereotacticTreatmentVerification49 Descriptions of Lucy 3D QA

Phantom Alignment Bases50 Maintenance50 Bibliography51 Parts and Accessories List52 FeaturesandSpecifications56 Service Policy56 Customer Responsibility57 Warranty

Table of Contents

PAGE

Overview

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. Thephantomallowsverificationoftreatmentplanning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verificationisaccomplishedviacomponentsthataccommodateionchambers,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 cav-ity 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 al-low 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 position-ing assembly which permits 360° rotation in transverse, sagittal and coronal planes.

3120 DEMING WAYMIDDLETON, WI 53562-1461 USAWWW.STANDARDIMAGING.COM

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Overview Continued

The Lucy 3D QA Phantom is mounted on the Precision Leveling and Rotational Alignment Base, REF 70021, or in the Stereotactic FrameInterfaceforthespecificSRStreat-ment 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 er-ror 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.

Many options exist for SRS treatment planning and delivery. To perform tests specifictothesystembeingevaluated,theuser must select the accessories appropri-ate for the required tests. An example of a verificationprotocolisgiveninthismanualsectionStereotacticTreatmentVerification.The user must be aware that tests for their specificRSRsystemwillvarydependingonthe operation of their system.

The Lucy 3D QA Phantom will assist in meet-ing the recommendations of TG 40 Compre-hensive QA for Radiation Oncology, TG 42 Stereotactic Radiosurgery, TG 53 Quality As-surance for Clinical Radiotherapy Treatment Planning, and TG 66 Quality Assurance for Computer-tomography Simulators.

Lucy 3D QA Phantom Setup

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 Mamase-shan, PhD; 2001.

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 Shortfillerplug(1)6 Shortfillerplugcavity(1)7 Longfillerscrewcavity(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)

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Lucy 3D QA Phantom Setup

Figure 1a: Lucy 3D QA Phantom Sphere Features

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Lucy 3D QA Phantom Setup Continued

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Figure 1b: Lucy 3D QA Phantom Sphere Dimensions

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Lucy 3D QA Phantom Setup Continued

Figure 3: Lucy 3D QA Phantom shown in sagittal mounting position on standard base

Figure 2: Lucy 3D QA Phantom shown in transverse mounting position on standard base

Figure 4: Standard Base for the Lucy 3D QA Phantom, including Standard Clamp

Standard Base Includes:1 Standard Veritcal Support2 Posterior Base3 Counterbalance weight of lead4 Anterior Base5 Leveling Screws (3)

Standard Clamp Includes:6 Standard Neck7 Screw Clamp

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Dosimetry QA Accessory Package Description

This package includes the following ac-cessories:

• Dosimetry Insert for Ion Chamber (multiple REF numbers)

• Dosimetry Film Cassette for three 2.5" x2.5"films(REF70084)

• Target / Treatment Verification Film Cassette (REF 70078)

Dosimetry Insert for Ion Chamber (mul-tiple 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 insertcan be made to accommodate any of the small ion chambers typically used for small fielddosimetry.Thethicknessoftheinsertis 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 7: Lucy 3D QA Phantom assembled with the ion chamber locked in position

Figure 6: Open Lucy 3D QA Phantom showing the Exradin A14SL or A16 Microchamber in position.

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Figure 8: Schematic of Dosimetry Insert for Ion Chamber (Exradin A16 version) showing dimensions in mm

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Dosimetry Film Cassette for three 2.5" x 2.5" films (REF 70084)This cassette positions three films at theexact center of the Lucy 3D QA Phantom forfilmdosimetrymeasurements.Thetwofilmsoneither sideof the central filmareseparated 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

Dosimetry QA Accessory Package Continued

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Figure 10a: Schematic of Dosimetry Film Cassette for three 2.5" x 2.5" films showing dimensions in mm

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Figure 10b: Schematic of Dosimetry Film Cassette for three 2.5" x 2.5" films showing dimensions in mm

Dosimetry QA Accessory Package Continued

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Target/Treatment Verification Film Cas-sette (REF 70078)This cassette is made of black acrylic so it can accommodate radiochromic or conven-tional therapyfilm. Itpositionsone3 inchfilmattheexactcenteroftheLucy3DQAPhantom. There are sharp markers in the Target/TreatmentVerificationFilmCassettewhich will produce four impressions forming a square on the filmequidistant from thecentre. TheTarget/TreatmentVerificationFilmCassettehasafifthmarker,apositionindicator.Thisfifthorientationmarkerpro-ducesanimpressiononthefilmandaswellin 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

Dosimetry QA Accessory Package Continued

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Figure 13: Schematic of Target/Treatment Verification Film Cassette showing dimensions in mm

Dosimetry QA Accessory Package Continued

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This package includes the following ac-cessories:

• 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 pro-grams. 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.Theyfitintocavitiesinonehemi-sphere of the Lucy 3D QA Phantom which are spaced on a rectangle 60 mm center to center.Eachmarkerscontainsfive2mmdi-ameter aluminum spheres which are spaced 5 mm center to center.

CT Imaging QA Accessory Package Description

Figure 14: Close-up of the four cylinders

Figure 15: CT Scan of cylinders

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CT Imaging QA Accessory Package Continued

Figure 16b: Schematic of CT Marker Cylinder location within the Lucy Sphere showing dimensions in mm

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CT Volume Insert with 3 irregular known volumes (REF 70076)This insert has three irregularly shaped air volumes of 250, 750, and 1750 mm3. 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.

CT Imaging QA Accessory Package Continued

Figure 17: CT Volume Insert

Figure 18: CT Scan of the insert

Figure 19: Table of the three geometries with the areas and volumes listed

Area Volume

Geometry 1 250 mm 2500 mm3

Geometry 2 750 mm 7500 mm3

Geometry 3 1750 mm 17500 mm3

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CT Grid Insert for spatial distortion (REF 70075)This insert is a two dimensional metallic grid specifically designed for checking imagedistortion and symmetry. Grid lines are vis-ible 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.

CT Imaging QA Accessory Package Continued

Figure 20: CT Grid Insert

Figure 21: CT Scan of insert

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Figure 22: Schematic of CT Grid Insert for spatial distortion showing dimensions in mm

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This package includes the following ac-cessories:

• 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 pro-grams. 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.Theyfitintocavitiesinonehemi-sphere of the Lucy 3D QA Phantom which are spaced on a rectangle 60 mm center to center. Eachmarkerscontainsfive2mmdiameterspheresfilledwithmineraloil.Thespheres are spaced 5 mm center to center.

MRI Imaging Accessory Package Description

Figure 23: Close-up of the four cylinders

Figure 24: Schematic of a MRI Marker Cylinder showing dimensions in mm

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MRI Volume Insert with 3 irregular known volumes (REF 70077)This insert has three irregularly shaped vol-umeswhicharefilledwithmineraloil.Theareas 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 thatoccurcanbequantified.

MRI Imaging Accessory Package Continued

Figure 25: MRI Volume Insert

Figure 26: Table of the three geometries with the areas and volumes listed

Area Volume

Geometry 1 250 mm 1700 mm3

Geometry 2 750 mm 5250 mm3

Geometry 3 1750 mm 12250 mm3

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MRI Imaging Accessory Package Continued

Figure 27: Schematic of MRI Volume Insert showing dimensions in mm

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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 im-age the MRI Marker Cylinders and the MRI Volume Insert.

MRI Imaging Accessory Package Continued

Figure 28: MRI Signal Generator

Figure 29: MRI image of cylinders, volume insert, and signal generator

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MRI Imaging Accessory Package Continued

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Figure 30: Schematic of MRI Signal Generator showing dimensions in mm

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The Radiation Alignment Pointer (REF 70079) attaches to the Precision Leveling and Rotational Alignment Base (REF 70021) for secure positioning. Two alignment point-ers 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 radio-graphicfilm.

Radiation Alignment Pointers

Figure 31: Close up of the pointer tips

Figure 32: Pointer on base

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Figure 33: Schematic of Radiation Alignment Pointer

Radiation Alignment Pointers Continued

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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 orientationpurposes.Theyfitintocavitiesinone 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.

Additional Accessories Description

Figure 34: Close-up of the four cylinders

Figure 35a: Schematic of an IGRT Localization & Angiography Marker Cylinder showing dimensions in mm

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Additional Accessories Description

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

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Dosimetry Film Cassette for Three 3.0" x 3.0" Films (REF 70091)This cassette positions three films at theexact center of the Lucy 3D QA Phantom forfilmdosimetrymeasurements.Thetwofilmsoneither sideof the central filmareseparated 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.

Additional Accessories Continued

Figure 36: Cassette with the four spacers

Figure 37a: Schematic of Dosimetry Film Cassette for Three 3.0" x 3.0" Filmsshowing dimensions in mm

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Additional Accessories Continued

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Figure 37b: Schematic of Dosimetry Film Cassette for Three 3.0" x 3.0" Filmsshowing dimensions in mm

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Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Films (REF 70089)Thiscassettepositionsthirteenfilmsinthelarge void in one hemisphere of the Lucy 3D QAPhantom for filmdosimetrymeasure-ments. The cassette and spacers are made of clear acrylic. One spacer has ten 1 mm holes for orientation purposes.

Additional Accessories Continued

Figure 38: Cassette with the fourteen spacers

Figure 39a: Schematic Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Filmsshowing dimensions in mm

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Additional Accessories Continued

Figure 39b: Schematic Dosimetry Film Cassette for Thirteen 2.5" x 2.5" Filmsshowing dimensions in mm

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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” x2.5”filmswhichcanbeusedseparatelyto verify dosimetric delivery. The insert contains two core target shapes with cor-responding avoidance structures which can be used to test complex dose delivery plans and a relative dose shape against objects of known dimensions.

Additional Accessories Continued

Figure 40: Multiple Target Shapes Insert Kit

2.11 mm

Ø 6.0 mm

R 3.18 mm

Ø 20.0 mm 31.75 mm

7.11 mm

Ø 6.0 mm

Ø 10.0 mm

Ø 20.0 mm

Figure 42: Core Target Shape Dimensions (not drawn to scale)

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Additional Accessories Continued

Figure 43: Multiple Target Shapes Insert Kit Schematic

80.65

80.65

A A

34.90

SECTION A-A

63.35

63.35

20

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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.

Additional Accessories Continued

Figure 44: Dosimetry Insert for MOSFET Detectors

Figure 45: CT Scan of Insert

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Figure 46: Schematic of Dosimetry Insert for MOSFET Detectorsshowing dimensions in mm

8.00

10.00

5.00

8.10

3.10 3.10

5.00

2.654.257.50

Additional Accessories Continued

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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.

Additional Accessories Continued

Figure 47: Dosimetry Insert for TLD Detectors

Figure 48: CT Scan of insert

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Figure 49: Schematic of Dosimetry Insert for TLD Detectorsshowing dimensions in mm

Additional Accessories Continued

84.95

84.95

6.6

42.48

10

10

A

3.40

3.40 3.10

3.10

DETAIL A SCALE 5 : 1

7.502.00 3.00

84.95

84.95

6.6

42.48

10

10

A

3.40

3.40 3.10

3.10

DETAIL A SCALE 5 : 1

7.502.00 3.00

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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.

Additional Accessories Continued

Figure 50a: Schematic of Dosimetry Insert for TLD Detectorsshowing dimensions in mm

5.00

42.48

5.00

A

3.50

84.95

84.95

3.50

7.50

2.00

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Figure 50b: Schematic of Dosimetry Insert for TLD Detectorsshowing dimensions in mm

Additional Accessories Continued

DETAIL A SCALE 6 : 1

1.20

1.50

1.50

1.20

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Electron Density QA Insert (REF 70104)

This insert provides four independent targets plus the surrounding material made of differ-ent CT electron densities, and is designed to fitinsidetheexistingcavityintheLucy3DQA 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 sur-rounding material is Blue Water (nominal CT value: 70).

Additional Accessories Continued

NO INSERT - REMAINS EMPTY

ADIPOSE INSERT

TRABECULAR BONEINSERT

CORTICAL BONEINSERT

REFERENCE HOLE

Figure 51: Electron Density QA Insert

# MaterialDensity [g/cm3]

Nom. CT

Value [HU]

Electron Density [per cc x 1023]

1 Adipose 0.94 -60 3.102

2 Trabecular Bone 1.20 220 3.863

3 Cortical Bone 1.91 850 5.9524 Air (no insert) – – –5 Blue Water 1.09 70 3.524

Figure 52: Electron Density QA Insert

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Additional Accessories Continued

Figure 53: Schematic of Electron Density QA Insertshowing dimensions in mm

84.95

84.95

22.35

39.88

10.00

Ø 20.07

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MRI Isocentric Volume Insert (REF 70107)

Additional Accessories Continued

Developed in cooperation with Sam Han-cock, Ph.D. of Southeast Missouri Hospital this insert has a single isocentrically placed irregularlyshapedvolumewhichisfilledwithmineral oil. The insert allows for complete end-to-end QA of the complete radiosur-gery 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

accuracywhenthefilesaretransferredfromone 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

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Additional Accessories Continued

84.94

84.94

10.01

1.5

8.5

Figure 55: Schematic of MRI Isocentric Volume Insert

1 2

3

Area Volume

Geometry 1 127 mm 890 mm3

Geometry 2 127 mm 890 mm3

Geometry 3 750 mm 5250 mm3

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Getting Started Checklist

Before you begin, review the following checklist:

1. When obtaining Dosimetric QA Measurements using:

Ion Chambers: ConfirmyouhavethecorrectDosimetryInsertforIonChamberFig.1,fortheion

chamber you will be using. Test the ion chamber with the Dosimetry Insert for Ion Chamber to be certain it

fits.

Film: ConfirmyouhavefilmavailablefortheDosimetryFilmCassetteyouwillbeusing;

four Dosimetry Film Cassettes Fig. 2, are available. Confirmfilmpieceshavebeencuttothepropersize. Decidehowthefilmdensitywillberelatedtodose…usingascanningsystemor

visual inspection. Ifusingfilmthatneedstoberunthroughanautomaticprocessor,determinehow

thiswillbedone.Typically,thesmallpieceoffilmistapedtotheendofalargepieceoffilmandthenbotharerunthroughtheprocessor.

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.

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The Lucy 3D QA Phantom includes the Lucy Midchamber Plug with 4 mm Brass Ball (REF 50209) which can be utilized as a positionverificationandisocenteralignmenttest object.

Position VerificationSetting up the Lucy 3D QA Phantom and securingtheinterfacetoyourspecificstereo-tactic 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 treat-ment 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.Ensurethefiducialmarkersofthe 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. Usingthefiducialmarkersofthepatienttreatment frame locate the machine isocenterofyourtreatmentfield.

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 TestUtilizing the Lucy MidChamber Plug a com-plete 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 treat-ment 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.Ensurethefiducialmarkersofthe 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 im-agesofthetreatmentfieldsutilizingtheMVimagingsystemorfilm.

8. Evaluate the position of the radio-opaque marker in relation to the treat-mentfieldintheobtainedimages.

Position Verification and Isocenter Alignment Testing

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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.Ensurethefiducialmarkersofthe 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 treat-ment 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 treat-ment planning system to the known target volumes toconfirm thecorrectvolumes 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 Lucy3DQAPhantomspecifications.

'Distance Measurements' QA Process

7. Exact manufacturing tolerances allow you to compare the Lucy 3D QA Phan-tom distance measurements to the dis-tance measurements of images in treat-ment 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 beverifiedinallplanesusedfortreat-ment planning, transverse, sagittal, and coronal.

NOTE: Any discrepancy should be noted for further action.

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To perform distance measurements, firstidentifytheisocenter(s)usedintheplan 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 filmdosimetry.Plansshouldbedonein 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 casewhere laserset-up to marked points is used. For other techniques the actual set-up will be different.

'Dosimetry Measurements' QA Setup Process

8. InserttheTarget/TreatmentVerificationFilm Cassette Fig. 8, in the Lucy 3D QA Phantom. The cassette can accept commercially available radiochromic or conventionaltherapyfilm;iflight-sensi-tivefilmisused,testthefilmcassettetoensure it is light proof. There are sharp markers in the Target/Treatment Veri-ficationFilmCassettewhichproducefour impressions forming a square on the film equidistant from the center.TheTarget/TreatmentVerificationFilmCassettehasafifthposition indicatormarker.This fifth orientationmarkerproducesanimpressiononthefilmandindicates the orientation of the Lucy 3D QA Phantom within the treatment plan-ning 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 Phan-tom 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 the-film,anddelivertheprescriptiondoseto the Target/Treatment Verification Film Cassette within the Lucy 3D QA Phantom. Then treat the Lucy 3D QA Phantom with the selected prescrip-tion dose.

11.Processandhandletheexposedfilmas needed depending on the type of filmbeingused.

12.Locatethecenterofthefilmusingthefourmarksthatareonthefilmlocatedtowards each corner of the square. Thefifthmarkonthefilmwillindicatethe orientation of the Lucy 3D QA Phantom.

'Planned Dose to Delivered Dose' Com-parison Process

13. To compare the delivered radiation pattern with the planned dose distri-bution, the film density patternmustbe registered with the planned dose distribution3. To compare the planned dose to the delivered dose, an isodose distribution must be produced from the filmandoverlaidonthetreatmentplanisodose distribution. (Use the tools available within the treatment planning system to compare the isodose distribu-tionproducedonthefilmtotheplannedisodose distribution or visually compare thedevelopedfilmtotheprintedhardcopy of the treatment plan.) Note: Any discrepancy should be noted for further action.

Stereotactic Treatment Verification Continued

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Stereotactic Treatment Verification Continued

14. In a similar manner, the Dosimetry Insert for Ion Chamber may be used to confirmprescribeddoseat theexactcenter of the Lucy 3D QA Phantom. The TLD Dosimetry Cassette and the MOSFET Dosimetry Cassette may also be used for dosimetry tests.

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Descriptions of Lucy 3D QA Phantom Alignment Bases

Standard Precision Leveling and Rota-tional Alignment Base - REF 70021

The original standard alignment base (Figure 4) provides great functionality for many ap-plicationswhereaspecificstereotacticframeis not desired to be mounted in the testing scenarios, including:

1. Thebase is free-standingonflatsur-faces 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 mount-ed 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 posi-tions, in either coronal or transverse mounting, and repeated over time or place.

(General Electric) MRI Headcoil Base - MRGE-B

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.

NOTE: If the Lucy 3D QA Phantom is to be imaged in the body coil, the Simple Level-ingBase(REF70038)mayfitonthecouchsurface of some MR models. In either case, theLucy3DQAPhantomisfittedwiththeMRI accessories (REF 70074, REF 70077, and REF 70063, for example) to provide self-generatingsignal,andtheMRfiducialpoints and target volumes.

Stereoadapter 5000 Stereotactic Frame Supports (used with 70021 and GEMRI-A) - REF 70101

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 Sup-port (used with 70021) - REF 70102

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 surgi-cal accessories may be mounted on vertex of stereoadapter, i.e. biopsy targeting kit, IGS tracking devices, etc.

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Bibliography

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.

Maintenance

If assistance is desired in the proper disposal of this product (including accessories and components), after its useful life, please return to Standard Imaging.

1. R. Ramasesham, M. Heydarian, “Comprehensive quality assurance for stereotactic radiosurgery treatments”, Phys. Med. Biol. 48(2003) N119-N205.

2. R. Ramani, et.al., “A QA phantom for dynamic stereotactic radiosurgery: Quantitative measurements”, Med. Phys. 22(8), August 1995.

3.R.Ramani,et.al.,“TheuseofRadiochromicfilmintreatmentverificationofdynamicstereotactic radiosurgery”, Med. Phys. 21(3), 1994.

4. AAPM Radiation Therapy Committee TG53: “Quality assurance for clinical radiotherapy treatment planning”, Med. Phys. 25(10), October 1998.

5. AAPM Radiation Therapy Committee TG66: “Quality assurance for computed-tomography simulators and the computed-tomography-simulation process”, Med. Phys. 30(10), October 2003

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Parts and Accessories List

REF

91210700213016650209

7010070039708537009370101

70096-C0370096-C0470096-C0970096-C1270096-C1370096-C1470096-C1570096-C1670096-C1770096-C1870096-C2170096-C2270096-C2370096-C2770096-C2870096-C297008470078

700737007670075

700747007770063

70079

7007370084700897008370058700597010670104760137010772257

9001592726927239270592729

Description

Lucy 3D QA Phantom - Spherical Lucite PhantomPrecision Leveling and Rotational Alignment BaseBlank Filler Plug (HEMI-C)Lucy Midchamber Plug with 4mm Brass Ball

Stereotactic Frame InterfacesLeksell G Gamma Knife® / 3-D Line Stereotactic Frame InterfaceBrainLAB Stereotactic Frame InterfaceRadionics™ / CRW/BRW Stereotactic Frame InterfaceVarian / CRW/BRW Stereotactic Frame InterfaceSandstrom Stereo-Adapter Stereotactic Frame Interface

Lucy Dosimetry QA Accessory Package- One of the following chamber inserts:

- Dosimetry Insert for Model A1SL Exradin Ion Chamber, 0.056 cc- Dosimetry Insert for Model A14SL Exradin Ion Chamber, 0.009 cc- Dosimetry Insert for Model A16 Exradin Ion Chamber, 0.007 cc- Dosimetry Insert for Wellhofer-CC13 Ion Chamber- Dosimetry Insert for Wellhofer-CC04 Ion Chamber- Dosimetry Insert for Wellhofer-CC01 Ion Chamber, 0.01 cc- Dosimetry Insert for PTW 23323 Ion Chamber- Dosimetry Insert for PTW 31010 Ion Chamber, 0.125 cc-DosimetryInsertforPTWSemiflex,0.3ccIonChamber- Dosimetry Insert for PTW 31014 (T31006) Ion Chamber- Dosimetry Insert for PTW Pinpoint 3D Ion Chamber- Dosimetry Insert for PTW 60008 Ion Chamber- Dosimetry Insert for PTW Pinpoint, 0.03cc Ion Chamber- Dosimetry Insert for Model A18 Exradin Ion Chamber, 0.125 cc- Dosimetry Insert for Scanditronix SFD DEB050 Ion Chamber, 4.25 mm- Dosimetry Insert for Scanditronix SFD Ion Chamber, 5.11 mm

- Dosimetry Film Cassette for four 2.5 x 2.5 inch Films-Target/TreatmentVerificationFilmCassette

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 AccessoriesIGRT Localization & Angiography Marker Cylinders, set of fourDosimetryFilmCassetteforfour2.5"x2.5"filmsDosimetryFilmCassetteforfourteen2.5"x2.5"filmsDosimetryFilmCassetteforfour3.0"x3.0"filmsMOSFET Dosimetry CassetteDosimetry Insert for 3mm TLD Detectors Dosimetry Insert for 1mm TLD Detectors Electron Density QA InsertMultiple Target Shapes Insert KitMRI Isocentric Volume InsertBlank Midchamber Plug (HEMI-A)

MAX 4000 ElectrometerExradin A16 MicroChamberExradin A14SL MicroChamberExradin A1 Thimble Ion ChamberExradin A18 Thimble Ion Chamber

Leksell Gamma Knife® is a registered trademark of Elekta Instruments, Inc.

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Features and Specifications

Specifications are subject to change without notice.

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

Dosimetry QA Accessories Dosimetry Insert for Ion Chamber DosimetryFilmCassetteforfour2.5"x2.5"films Target/TreatmentVerification - Film Cassette - Four Titanium Fiducial Markers - One Titanium Fiducial Marker for Orientation DosimetryFilmCassetteforFour3.0"x3.0"films DosimetryFilmCassetteforFourteen2.5"x2.5"films 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

Radiation Alignment Pointer Includes 3 mm Optical Alignment Tip and Radiation 5 mm Alignment Tip

Acrylic Sphere 140 mm (5.51 in) diameter81 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)

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)

10 mm (.39 in) length, 25 mm (.98 in) diameter 5 mm (.197 in) center-to-center85 x 85 x 10 mm (3.35 x 3.35 x .39 in)Area 250 mm, Volume 2500 mm3

Area 750 mm, Volume 7500 mm3

Area 1750 mm, Volume 17500 mm3

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-center85 x 85 x 10 mm (3.35 x 3.35 x .39 in)

Area 250 mm, Volume 1700 mm3

Area 750 mm, Volume 5250 mm3

Area 1750 mm, Volume 12250 mm3

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

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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

Standards 93/42/EEC

See www.standardimaging.com for applicable tech notes.Specifications are subject to change without notice.

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)

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Notes

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Customer ResponsibilityService Policy

This product and its components will perform properly and reliably only when operated and maintained in accordance with the instruc-tions contained in this manual and accompa-nying 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 pe-riod, 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 function-ing 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.

If service, including recalibration, is required, please contact Standard Imaging’s Customer Service department by phone or email prior to shipping the product. Standard Imaging’s Customer Service and Technical Service staff will attempt to address the product is-sue via phone or email. 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 clearlyidentifiedontheoutsideofthepack-age.The customermust immediately filea 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 aspecificshipper.Itemsfoundtobeoutofwarranty 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 serial-ized contain coded logic in the serial number which indicates the product, day and year of manufacture, and a sequential unit number foridentification:

A YY DDD X

AYY

DDDX

Unique product IDLast two digits of the year(e.g. 1999 = 99, 2000 = 00)Day of the year (1< DDD < 365)Unique unit ID Number (1 < X < 9)

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Warranty

Standard Imaging, Inc. sells this product under the warranty herein set forth. The war-ranty 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 Im-aging, Inc. or if the product has been subject to abuse, misuse, negligence or accident.

Product Warranty PeriodStandard Imaging Ionization Chambers 2 yearsStandard Imaging Well Chambers 2 yearsStandard Imaging Electrometers 5 yearsStandard Imaging BeamChecker Products 2 yearsStandard Imaging Software Products 1 yearAll Other Standard Imaging Products 1 yearStandard Imaging Custom Products 1 yearStandard Imaging Remanufactured Products 180 daysStandard Imaging Custom Select Products 90 daysConsumables 90 daysServiced Product 90 daysResale Products AsdefinedbytheOriginalEquipmentManufacturer

ADCL Product Calibration(Standard Imaging uses the UW-ADCL forrecalibrations required under warranty)

0 - 90 days = 100% of ADCL Calibration Costs91 - 182 days = 75% of ADCL Calibration Costs

183 – 365 days = 50% of ADCL Calibration Costs366 – 639 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 con-tains 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, includinganyimpliedwarrantyoffitnessforaparticularpurpose.InnoeventshallStandardIm-aging, 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.