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User’s Guide, MultiPHAN
© 2019 by Gammex Inc. All rights reserved.
The information contained in this guide is copyrighted and all rights are reserved
by Gammex Inc. Copying, duplicating, selling, or otherwise distributing any part of
this manual without the prior written consent of Gammex Inc. is prohibited.
Gammex Inc. reserves the right to make periodic modifications to this manual with-
out obligation to notify any person or entity of such revision.
This guide is written for Model 2823.
Document 008888-00-00

Gammex Inc.
7600 Discovery Drive
Middleton, WI 53562 USA
+1 608-828-7000
www.gammex.com

ii
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . 2
Intended Use . . . . . . . . . . . . . . . . . . . .2
Limitations of Use . . . . . . . . . . . . . . . . .2
Quality and Regulatory Systems . . . . .2
Health and Safety Information . . . . . . .2
Regulatory Information . . . . . . . . . . . . .3
About the MultiPHAN . . . . . . . . . . . 5
Description . . . . . . . . . . . . . . . . . . . . . .5
MultiPHAN Design . . . . . . . . . . . . . . . .6
MultiPHAN Diagrams . . . . . . . . . . . . . .8
Support and OperationCleaning . . 9
Initial Setup . . . . . . . . . . . . . . . . . . . . .9
Daily Procedure . . . . . . . . . . . . . . . . . .9
1
Support and Maintenance . . . . . . 13
Maintaining Hardware . . . . . . . . . . . . 13
Disposal and Recycling . . . . . . . . . . . 13
Contacting Gammex Technical
Support . . . . . . . . . . . . . . . . . . . . . . 13
Specifications . . . . . . . . . . . . . . . . 15
Product Specifications . . . . . . . . . . . . 15
Appendix A: Regulatory Supple-
ment . . . . . . . . . . . . . . . . . . . . . . . 17
Symbols . . . . . . . . . . . . . . . . . . . . . . . 17
Operator Responsibility . . . . . . . . . . . 18
Reporting Health or Safety Related
Issues or Concerns . . . . . . . . . . . . . 18
 Preface
Intended Use

The MultiPHAN is intended for routine and periodic verification of the coincidence
of laser positioning, portal imaging, cone-beam CT, and light field systems with
Radiotherapy Treatment Systems consistent with internationally recognized
standards.

Limitations of Use

Do not use results from the MultiPHAN to make changes to your system, do use
the results to perform additional system checks.

Quality and Regulatory Systems

Gammex meets quality system standards including ISO 13485, FDA 21 CFR 820
Quality System Regulation, Health Canada’s Medical Device Regulation.
Gammex Quality Management System is certified to 13485 by SGS.
Gammex employs self-certification in the application of the CE mark to this class I
device in accordance with the Medical Device Directive, 93/42/EEC, Annex VII.
Gammex Class I medical products are listed in Europe with the Competent Author-
ity of Germany.

Health and Safety Information

WARNING: Freezing temperatures will damage the phan-

tom. Store the phantom at room temperature or within the
35° to 105° F (2° to 40° C) storage range.

• Do not operate the phantom if visual inspection identifies physical damage.

Physical damage causes premature desiccation.

The MultiPHAN must be used in accordance with the

instructions in this manual. Read all instructions and safety
labels before use.

For instructions to report health or safety related concerns, see Reporting Health
or Safety Related Issues or Concerns on page 18.

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Regulatory Information

For a definition of the symbols used throughout this document and additional
information related to user and device safety, see Appendix A: Regulatory
Supplement on page 13. Review this information thoroughly before setting up and
using the instrument.

3
 1 About the MultiPHAN
Description
The MultiPHAN is designed to test alignments of the treatment beam origin with the
diverse set of image guidance systems used for patient alignment during radiation
therapy. This includes:
• Treatment beam isocenter
• Light field
• Lasers
• kV Imaging
• MV Imaging
• CBCT
• TomoTherapy MVCT
3D and 6D repositioning with the treatment couch

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MultiPHAN Design
The MultiPHAN is a cube constructed primarily of HE CT Solid Water®. Internally,
there is a set of 5 registration rods composed of bone-mimicking material. In the
AP and lateral projection views, these rods align in an X-shape to facilitate manual
or automatic registration.
At the center of the cube is a 6.4 mm ceramic target. This target is used to identify
the isocenter in different treatment and imaging systems. The central target is
denoted by scribe lines on the surface of the cube. The anterior and lateral surfaces
also have grooves encircling the target such that the target alignment can be
visually corroborated in projection views.
There is another 6.4 mm ceramic target offset from the main target. This target is
commonly used to test repositioning, notably by offsetting the phantom to place this
2nd target at the isocenter and confirm that the MultiPHAN can be properly
repositioned.
In addition to the scribe lines denoting the central and off-center target, there are
L-shaped scribes on the MultiPHAN surface corresponding to a 10 cm x 10 cm field
size at isocenter.
Note: The MultiPHAN includes a stand that can be used for repositioning tests.
Specifically, the stand includes 2 discrete locations that accommodate the
phantom. The first of these (on the Left+Inferior side of the stand) is used for setting
up the phantom at isocenter. The phantom can then be shifted to the other location,
on the Right+Superior side of the stand, to place the offset marker at isocenter
(note that the vertical placement should be performed with the couch). The stand
also includes 2 kickstands to create discrete and reproducible rotational
adjustments and 3 knobs to create variable rotational offsets. The kickstands and
knobs can be used to test registration and 6D couch-based repositioning. Finally,
the stand includes 3 BBs that can be used to measure pixel size in the detector.
Note that the stand comes with 3 rubber feet on the ends of each nylon screw. These feet
can be used to protect certain sensitive couch-top materials, such as mylar laminate, from

6
the risk of damage by the nylon screws. If the cube is not being used with such a couch-top,
then the rubber feet can be twisted off or cut off by the user.

7
MultiPHAN Diagrams

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 2 Support and OperationCleaning
Initial Setup

When first receiving the MultiPHAN, collect high quality CT scans of the phantom
and then generate a simple treatment plan that can facilitate isocenter testing on
the treatment system. As part of this step, we recommend checking that the CT
simulator lasers are aligned with the CT image plane. We also recommend re-
checking this alignment regularly (e.g. following TG 66) and if adjustments are
required, updating the alignment and treatment plans.
1 Align the MultiPHAN with the lasers on the CT Simulator.
2 Collect CT images.
a. We recommend collecting a set of high-quality CT scans, such as with axial
slices, a high dose, and a thin slice thickness.
3 Transfer the images to a TPS and generate a simple plan for the MultiPHAN.
The treatment plan isocenter should be at the center of the MultiPHAN.
a. Users might find it beneficial to contour the bone-mimicking rods and the
two ceramic markers.
4 Generate DRRs for both the lateral and AP directions.
Note: In some treatment planning systems, use of bone setting when creating the
DRRs for MV and kV images helps improve visibility of the alignment rods.

Daily Procedure

Confirm Coincidence of Lasers with Treatment Isocenter

1 Set up the MultiPHAN on the treatment system using the lasers for alignment.
a. For sake of testing repositioning later, it is recommended to setup the Mul-
tiPHAN using the included stand.
b. The superior and inferior ends of the stand should be oriented consistently
with the LINAC, and the MultiPHAN should be placed in the indentation on
the Left+Inferior side of the stand.
2 Collect AP and lateral views using the MV imager.
3 Review the images to confirm that the rods form an X-pattern. If not, adjust the
phantom position and recollect the MV images.
4 Perform a registration between the MV images and the DRR images using the
treatment console registration software.
5 Confirm that this registration offset falls within desired clinical tolerances.

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Confirm Coincidence of kV Imaging with Treatment Isocenter
1 Setup and check the position of the MultiPHAN, as defined above.
2 Collect AP and lateral views using the kV imager.
3 Perform a registration between the kV images and the DRR images using the
treatment console registration software.
4 Confirm that this registration offset falls within desired clinical tolerances

Confirm Coincidence of CBCT and MVCT Imaging with Treatment

Isocenter
1 Setup and check the position of the MultiPHAN, as defined above.
2 Collect a CBCT or MVCT image volume.
3 Perform a registration between the CBCT/MVCT images and the original CT
volume using the treatment console registration software.
4 Confirm that this registration offset falls within desired clinical tolerances

Confirm Coincidence of Light Field with Radiation Field

1 Setup and check the position of the MultiPHAN, as defined above.
2 Turn on the light field to 10 cm x 10 cm.
a. This light field should match square denoted by the be scribe lines on the
MultiPHAN surface. The scribe lines correspond to a 10 cm x 10 cm field
when the MultiPHAN is setup at 100 SAD.
3 Collect an MV image of the phantom using a 10 cm x 10 cm radiation field.
4 Measure the radiation field to confirm that it is 10 cm x 10 cm. This
measurement can be done using common measurement tools like ImageJ, or
with dedicated analysis software like SunCHECK.

Confirm 3D Registration and Repositioning

1 Setup and check the position of the MultiPHAN, as defined above.
2 Shift the phantom from indentation on the Left+Inferior side of the stand to the
offset position on the Right+Superior side. This places the offset marker at the
treatment isocenter in the lateral and longitudinal directions.
3 Adjust the couch vertically so that the offset marker is at the isocenter.
4 MV image registration:
a. Collect AP and lateral images using the MV imager.
b. Register the MV images to the DRR images using 2D/2D registration at the
treatment console.
c. Confirm that the reported registrations match the known shifts of +35 mm
superior, -30 mm lateral, -30 mm vertical.
5 kV image registration:

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 a. Collect AP and lateral images using the kV imager.
b. Register the kV images to the DRR images using 2D/2D registration at the
treatment console.
c. Confirm that the reported registrations match the known shifts of +35 mm
superior, -30 mm lateral, -30 mm vertical.
6 CBCT/MVCT image registration:
a. Collect CBCT or MVCT images of the MultiPHAN.
b. Register the CBCT or MVCT images to the planning images using 3D/3D
registration at the treatment console.
c. Confirm that the reported registrations match the known shifts of +35 mm
superior, -30 mm lateral, -30 mm vertical.
7 If couch-based repositioning is available, use the couch to automatically move
the phantom back to the original position, such that the center of the
MultiPHAN is at the treatment isocenter.
8 Confirm the repositioned location visually, or by acquiring additional images.

Confirm 6D Registration and Repositioning

1 Setup and check the position of the MultiPHAN, as defined above.
2 Shift the phantom from indentation on the Left+Inferior side of the stand to the
offset position on the Right+Superior side. This places the offset marker at the
treatment isocenter in the lateral and longitudinal directions.
3 Add additional rotations by using the kickstands on the stand, by using the
screws on the stand, or by rotating the stand on the couch.
• Note that if you want to test the same rotations each time the test is run,
you can do so by using the kickstands, or by selecting a specific
thumbscrew and screwing it completely in each time the test is run. The
angle can be measured with a digital level.
4 Collect images using MV imaging, kV imaging, CBCT, and MVCT and perform
a registration on the treatment console.
5 If 6D couch-based repositioning is available, use the couch to automatically
move the phantom back to the original position, such that the center of the
MultiPHAN is at the treatment isocenter.
6 Confirm the repositioned location visually, or by acquiring additional images.

Confirm Optical Distance Indicator (ODI)

1 Remove the MultiPHAN from the stand and place directly on the couch.
2 Adjust the couch up or down such that central plane of the MultiPHAN lies at
the isocenter.
3 Measure the distance to the MultiPHAN surface using the ODI.

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4 Compare the ODI reading to the known phantom surface location (commonly
93 cm, given a 100 cm SAD setup and noting that the MultiPHAN is 14 cm on
a side, so the anterior surface is 7 cm above the isocenter).

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 3 Support and Maintenance
Maintaining Hardware

Repair
There are no user-serviceable components in the MultiPHAN. If there are problems
with the instrument, contact Gammex support.

Parts
Accessories can be ordered from the Gammex Sales department by telephone +1
608-828-7000 or email gammexsales@sunnuclear.com.

Cleaning
Clean the MultiPHAN with a mild detergent. Rinse the phantom with water and
wipe it dry.

CAUTION: Do not use solvents or abrasive cleaners.

Storage
Use and storage conditions are shown below. The phantom should not be
subjected to conditions of extreme cold or heat. A brittle fracture could occur with
sudden thermal shock from cold to warm conditions. Under very hot conditions, the
phantom materials may soften and deform.
Table 3-1.

Use Temperature 15 – 25o C

Storage Temperature 2 - 40o C
Storage and Use Relative Humidity 8 – 70%

Disposal and Recycling

Do not discard unit as waste. Recycle the components in accordance with local
regulations.

Do not throw in trash; dispose of in an environmentally friendly way.

Contacting Gammex Technical Support

Technical support is available from Gammex Inc. Contact the Support department:
• By telephone: +1 (321) 259-6862, option 3, then 3.
• By email: GlobalSupport@sunnuclear.com

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 4 Specifications
Product Specifications

Table 4-1. MultiPHAN

Characteristic MultiPHAN
Alignment System 5 high density rods, easy to visualize and register
on the LINAC; they work with CBCT, MV EPID, kV
imaging, 6D couches, and more
Isocenter Marker Low-Z ceramic bead. Encircled by a groove on
cube faces to check alignment in planar images
Offset Marker Low-Z ceramic bead at a fixed offset from
isocenter, for registration and repositioning
Light Field Test Scribe markers on the phantom surface indicate
the light field corresponding to a 10 cm x 10 cm
radiation field at isocenter
Tissue Equivalent Constructed of a CT HE Solid Water base, with
Gammex bone-mimicking registration rods
Easy to Align Thin white laser scribe lines extend the full
phantom length for fast and accurate alignment
Case Included
Stand (optional) Easily and precisely shift the cube from an
isocentric alignment to the offset target with this
discrete-positioning stand. The stand can also
enact rotations to test registration and
repositioning.
Dimensions 14 cm x 14 cm x 14 cm
Weight 2.7 kg (6.0 lbs)
Material HE CT Solid Water
All specifications subject to change

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15
16
 Appendix A: Regulatory Sup-
plement

Symbols

The following symbols are used in this guide and in Gammex, Inc. product labeling.

WARNING: This symbol indicates a hazard that could

result in major injury or equipment damage.

This symbol indicates a general mandatory action.

Consult instructions for use.

Do not throw in trash; dispose of in an environmentally friendly way.

Manufacturer’s Identification (name and address).

Date of Manufacture.

Serial Number.

Catalog Number.

Authorized representative in the European Community.

This symbol indicates conformity with EC Directives.

17
Operator Responsibility

The instructions in this manual are intended for trained clinical personnel. The
operator is solely responsible for the accurate setup and use of the phantom. The
operator of the instrument bears the full responsibility for validating measurement
results and calibrating the CT system.

Reporting Health or Safety Related Issues or Concerns

Should the need arise to report any safety or health related issues or concerns
regarding the use of Gammex products, contact Gammex directly or in the case of
our European customers, contact our Authorized European Representative. Gam-
mex's Authorized European Representative is:

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

Australian customers, contact Gammex’s Australian Sponsor:

alphaXRT Pty Ltd
Suite 1.15, 90-96 Bourke Road,
Alexandria, NSW, 2015, Australia

Modifications to Equipment

WARNING: No modifications may be made to this unit

without the expressed written consent of Gammex.
Unauthorized changes might present a risk to user or
patients or affect certification and will void the warranty.

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 4VO
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3275 Suntree Boulevard
sunnuclear.com
Melbourne, FL 32940 USA