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Technical Publication

XVI R5.0
Customer Acceptance Tests

Document ID: 1503162_07


Publication date: 2020-05
Language: English
Copyright statement
Copyright ©2020 Elekta Limited. All rights reserved. Do not copy or use this document, or parts
of it, without written agreement from Elekta Limited. All trademarks and registered trademarks
of Elekta products are the property of the Elekta Group.

Acknowledgement of other trademarks


Elekta acknowledges the trademarks and registered trademarks of other manufacturers that we
use in this document.

Referenced documents
Elekta does not supply all the documents that we refer to in this document with the equipment.
Elekta reserves the right to make the decision on which of the documents we supply with the
equipment.

Worldwide product manufacturing centers - Oncology


Elekta Limited
Linac House, Fleming Way,
Crawley, West Sussex. RH10 9RR.
United Kingdom
Tel: +44 (0)1293 544422, Fax: +44 (0)1293 654321

Elekta Beijing Medical Systems Co.,


Ltd.
No. 21, Chuang Xin Road,
Science and Technology Park,
Changping District,
Beijing. 102200
P.R. China
Tel: +86 10 8012 5400, Fax: +86 10 8012 5401

For technical help, contact your local Elekta representative


or Elekta product support - www.elekta.com/services

Document ID: 1503162_07 XVI R5.0


Customer Acceptance Tests
Page 2 ©2020 Elekta Limited.
Table of Contents

Table of Contents
Chapter Title Page

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 XVI Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

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Customer Acceptance Tests
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Introduction

1 Introduction
Section Title Page

1.1 Customer acceptance tests for the XVI system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7


1.2 Product configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Tools and test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.4 Adjustments during test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5 Equipment registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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Introduction

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Introduction
Customer acceptance tests for the XVI system

1.1 Customer acceptance tests for the XVI system


The tests in this document are the standard tests that Elekta do after the installation is
completed. The tests show that the XVI system:
• Is installed correctly
• Operates satisfactorily
• Operates to the specifications agreed in the Contract of Sale.

Note: If Elekta have to do other tests, that are not agreed as part of the Contract of Sale, there are
added costs.

Before you start the tests, make sure that the scale convention of the XVI system is the same as
the host digital accelerator. Refer to XVI Installation Information for more information.
After each test, record the result in this document in the space after the test procedure.
To do the tests in a minimum of time, Elekta recommends that you do them in the sequence of
this document. But, it is possible to do the tests in different sequences.

1.2 Product configurations


The XVI system is a product that is part of the Elekta linear accelerator configuration and is
available in these product configurations:
• Elekta Synergy®
• Elekta Infinity™
• Versa HD™
• Elekta Axesse™.

1.3 Tools and test equipment


The tools and test equipment necessary to complete the tests in this document are:
• 18FG Leeds X-ray imaging phantom
• A 1 mm copper (Cu) filter plate
• A ball bearing phantom
• The ball bearing reference data
• Catphan® CTP 503.

1.4 Adjustments during test


Only make the adjustments that you can complete with the controls that the user can access
during usual operation. If you make other adjustments, you can cause a change to the results of
earlier tests. Therefore, you must do these tests again.

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Introduction
Equipment registration

1.5 Equipment registration


When the applicable customer acceptance tests are completed, the representatives from Elekta
and the customer must make sure that all copies of the document have:
• The results tables completed correctly
• All signatures and the date of approval on the Certificate of Acceptance.
When the Customer Acceptance Tests are completed, send the approved customer acceptance
test document to Elekta.
• If the Customer Acceptance Tests are completed using an electronic Customer
Acceptance Tests (CAT) document, upload the approved electronic document to the
Elekta Customer Lifecycle Management (CLM) system for equipment registration.
• For Customer Acceptance Tests using hardcopies, the BU or Distributor keeps two
copies, and the customer keeps one copy. A copy of the approved Certificate of
Acceptance is uploaded to the CLM for equipment registration.

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XVI Tests

2 XVI Tests
Section Title Page

2.1 3D image quality tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11


2.1.1 Setting up the Catphan® phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.2 Doing the 3D uniformity test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.3 Doing a test of the 3D low contrast visibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.1.4 Doing a test of the 3D spatial resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.1.5 Doing a test of the 3D transverse vertical scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.1.6 Doing a test of the 3D transverse horizontal scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.1.7 Doing a test of the 3D sagittal geometric scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.2 Doing a test of the Table Move Assistant accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.3 Doing a test of the 3D Registration accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.3.1 Measuring VolumeView™ registration accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.3.2 Measuring MV registration accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.3.3 Results of registration accuracy measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2.4 Doing a test of the 2D Geometric accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
2.5 Doing a test of the 2D imaging system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.5.1 Doing a test of the 2D low contrast visibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.5.2 Doing a test of the 2D Spatial resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.6 Certificate of Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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XVI Tests
3D image quality tests

2.1 3D image quality tests


The 3D imaging tests show that the 3D image quality is in compliance with the specification.

Note: Elekta recommends that you give a minimum of 10 minutes between each scan.

2.1.1 Setting up the Catphan® phantom

1 Make sure that you warm up the X-ray tube.


2 Move the iso-rotation turntable of the treatment table to 0°.
3 Put the Catphan® phantom on the treatment table at the gantry end. Make sure that the top
of the box opens away from the gantry.
4 Remove the Catphan® phantom from the box and put it on the end of the opened box (see
Figure 2.1).

002705_001

Figure 2.1 Catphan® CTP 503 phantom


5 Put the spirit level (3), supplied in the box, on top of the Catphan® phantom in the G-T
direction (see Figure 2.2).

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1 2 3

180º

4
000851 ©2013 Elekta Limited

Figure 2.2 Catphan® CTP 503 phantom in position

(1) Thumbscrews (3) Spirit level


(2) Fourth alignment marker (4) Alignment markers 1 - 4
6 Do a check to make sure that the level is correct. Adjust if necessary.
7 Adjust the position of the box, until the white alignment markers on top of the Catphan®
phantom align with the isocenter.
8 Adjust the thumbscrews (1) until the Catphan® phantom is level (see Figure 2.2).
9 Use the room lasers to adjust the position of the Catphan® phantom. Make sure that the
sides of the phantom and the white alignment markers align with the isocenter.
10 In the G-T direction, align from the gantry end to the fourth alignment marker (2).
CAUTION 2.1
Do not rotate the gantry until you are sure the path of the radiation head, kV source arm, and
kV and MV detector arms is clear. If the path is not clear, a collision of the parts and the
treatment table can occur. If you ignore this caution, you can cause damage to the equipment.
11 Move the kV detector panel to the small FOV position.
12 Make sure that the S10 collimator cassette and F0 filter cassette are in the kV source arm.
13 Extend the kV source arm.

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2.1.2 Doing the 3D uniformity test

This test shows that the 3D Uniformity is in specification.

Specification ≤1.5%

Note: If you have to comply with the Atomic Energy Regulatory Board (AERB) in India, do not do this
procedure but follow the procedure in the Addendum to the XVI Customer Acceptance Test. This is
applicable in India only.

1 In the G-T direction, align from the gantry end to the fourth alignment marker on the
phantom (see Setting up the Catphan® phantom).
2 Make a new patient ID and name it CAT-Uniformity (see the XVI Instructions for Use to
set up a patient).
3 Make a new treatment name and name it Uniformity.
4 Make a new field name and name it Uniformity.
5 Click Acquire VolumeView™ image.
6 Select the CAT - Image Quality Uniformity preset and acquire an image.
After you acquire the VolumeView™ image, reconstruction starts automatically.
7 Click Accept.
This accepts the reconstruction results.
8 Click View Reconstruction.
9 In the Slice Averaging drop-down list, select 3 slices, (the equivalent to 1.5 mm).
10 In the Transverse image area, select the uniformity module (see Figure 2.3).

Note: This is usually the slice number 32 for the Catphan® CTP 503.

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2 cm
NOT TO SCALE 002706 ©2011 Elekta Limited

Figure 2.3 Uniformity module


11 Right-click in the Transverse image area, and select Pixel value Loc.
The Image probe dialog box appears (see Figure 2.4).

X Y Z 1 2

NOT TO SCALE 002707 ©2012 Elekta Limited

Figure 2.4 Image probe dialog box

(1) Box size (2) Interpolated zooming check box


12 Make sure that the Interpolated zooming check box is selected (see (2) Figure 2.4).

Note: Interpolated zooming makes the voxels in the Image probe dialog box appear to be smooth (see
the XVI Instructions for Use manual for more information).

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13 To see the Transverse image area, move the Image probe dialog box to the right side of the
Transverse image area.
14 Zoom in until the box size in the Image probe dialog box is 1.00 cm.
a In the Transverse image area, move the mouse pointer approximately 1 cm from the
left edge of the image area.
b Click and hold the right mouse button, and drag down to zoom in until the box size is
1.00 cm.
c If it is necessary, adjust the contrast and brightness.
15 Click the center in the Transverse image area.
16 Record the Mean pixel value that appears in the Image probe dialog box in Table 2.1.
17 In the Transverse image area, click in five different positions of the image (see Figure 2.5).
Record the coordinates in Table 2.1.

5 4.5 cm
Z

2 4

3
001571 ©2011 Elekta Limited

Figure 2.5 Transverse image - coordinate values


18 Record the Mean pixel values in Table 2.1 for all the selected positions.
19 Calculate the maximum percentage difference of the highest Mean pixel values recorded
(see Figure 2.6).

Figure 2.6 Equation


20 Record the result in Table 2.2.
21 Select Dismiss to exit the VolumeView Reconstruction window.
Test Results
The test results show that the transverse uniformity is in specification.

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Table 2.1 3D uniformity test result table

Measurement Position Coordinate position (cm) Mean pixel value


X Y Z
Position 1 - center 0 0 0 986.16
Position 2 -4.5 0 0 986.16
Position 3 0 0 -4.5 985.17
Position 4 +4.5 0 0 986.97
Position 5 0 0 +4.5 988.03

Table 2.2 Percentage difference result

Percentage difference 0.29

Flamarion Digitally signed by Flamarion

Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart


Barbosa Goulart
Date: 2020.09.22 15:11:33
-03'00'

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2.1.3 Doing a test of the 3D low contrast visibility

See Formulae for low contrast visibility for more information on the formulae used in this
procedure.

% Low contrast visibility


Specification ≤3.0%

1 To align the treatment table in the G-T direction and set up the Catphan® phantom, do one
of the steps that follow.
a Align the treatment table from the G-end with the first alignment marker on the
Catphan® phantom (see Setting up the Catphan® phantom).
b If you have a license for RATM, move the treatment table in the T-direction. For
Catphan® CTP 503 move the treatment table 11 cm (subtract from the current
position).
2 Make a new patient ID and identify it as CAT - Contrast.
3 Make a new treatment name and identify it as Contrast.
4 Make a new field and identify it as Contrast.
5 Click Acquire VolumeView™ image.
6 Select the CAT - Image Quality Contrast preset and acquire an image.
After the VolumeView™ acquisition is completed, reconstruction starts automatically.
7 Click Accept to accept the reconstruction results.
8 Click the View Reconstruction.
9 In the Slice Averaging list, select 3 slices.
10 In the Transverse image area, go to the contrast resolution module.

Note: This is usually slice number 32 for the Catphan® CTP 503.

11 Right-click in the Transverse image area, and select Pixel value Loc.
12 Use the PAGE UP and PAGE DOWN keys until the alignment markers are aligned vertically
and horizontally.
For Catphan® CTP 503 (see Figure 2.7):
– The Teflon rod (8) is in the top right position.
– The keyway (11) is at the bottom center position.

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5 2 6

8
9

4 7

10

9 9

3 11 2 1
002735_001

Figure 2.7 Contrast resolution module - Catphan® CTP 503

(1) Acrylic (5) PMP insert (9) Air rods


(2) Air insert (6) Teflon insert (10) Alignment marker
(3) Polystyrene insert (7) Delrin (11) Keyway
(4) LDPE insert (8) Teflon rod
13 Make sure that the Interpolated zooming check box is selected.
14 To see the Transverse image area, move the Image probe dialog box to the right of the
Transverse image area.
15 In the Transverse area, right-click the mouse button and drag until the polystyrene insert (3)
is approximately in the center.
16 Zoom in until the box size in the Image probe dialog box is 0.35 cm.
17 Put the mouse pointer on the center of the polystyrene insert (3), and then left-click the
mouse button.
The image appears in the center of the Image probe.
18 Make sure that the image in the Image probe dialog box shows only the polystyrene insert
(3). Make sure that you cannot see the edges of the polystyrene insert.
19 In the Image probe dialog box, record the Mean (pixel) and St.Deviation (standard
deviation) values of the polystyrene insert (3).
20 Do steps 17 to 19 again for the LDPE insert (4).
21 In the documentation supplied with the Catphan® Phantom, from the Sensitometry section,
get the values of:
– CTpolystyrene (-35)
– CTLDPE (-100)
22 Use the values in step 23 to calculate the low contrast visibility. Record the results in Table
2.4.
23 Use the values in step 19 in the equation below to calculate the low contrast visibility.

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Figure 2.8 Low contrast visibility equation

This is an example of the top element of the equation, with the values from step 21 :

Figure 2.9 Example equation to calculate low contrast visibility


24 Make sure that the low contrast visibility is in tolerance. Record the results in Table 2.4.
25 Select Dismiss.
This closes the VolumeView Reconstruction window.

Table 2.3 Contrast polystyrene insert results

Insert Mean pixel value Standard Deviation Hounsfield Unit (CT #


(Mean) (SD) est)
Polystyrene 950.42 13.64 -35
LDPE 906.46 18.00 -100

Note: Record the values in this test in full, this includes the numbers with a decimal point. For example
000.00.

Table 2.4 Percentage of low contrast visibility result

Percentage of low contrast visibility 2.34

Flamarion Digitally signed by Flamarion


Flamarion Barbosa Goulart Barbosa Goulart
Accepted by: Signature: Barbosa Goulart Date: 2020.09.22 15:12:41
-03'00'

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2.1.3.1 Formulae for Low contrast visibility

The test measurements show that the XVI system can sense the difference between water and
fat. To do the tests, Elekta use a Catphan® phantom with the materials that follow:
• Polystyrene, to simulate water
• LDPE, to simulate fat.
An object is defined as visible when the average CT numbers of the object and the background
are different by more than the local average Standard Deviation (SD). The SD is a measurement
of the noise.

1 2
Pixel count

Hounsfield units/pixel value


NOT TO SCALE 001472 ©2011 Elekta Limited

Figure 2.10 Separation of objects by more than one standard deviation

(1) LDPE (2) Polystyrene

Therefore the contrast visibility of an object can be defined by:

If the result of the above equation is greater than one, the object is visible.
Where:
• CT polystyrene is the mean CT number measured locally for polystyrene.
• CT LDPE is the mean CT number, measured locally for LDPE.
The formula to calculate the contrast in CT numbers is:

When the background is water, the formula to calculate the percentage contrast is:

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The formula to calculate the percentage low contrast visibility of an object is:

Therefore, the formula becomes:

Include the CT number for polystyrene and LDPE in this formula to get the value for low contrast
visibility:

If the result of the above equation is greater than one, the object is visible.

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2.1.4 Doing a test of the 3D spatial resolution

Specification A minimum of 10 line pairs per centimeter

1 To align the treatment table in the G-T direction and set up the Catphan® phantom, do one
of the steps that follow.
a Align the treatment table from the G-end with the applicable alignment marker on the
Catphan® phantom. For the Catphan® CTP 503, align the treatment table with the
second alignment marker.
b If you have a license for RATM, move the treatment table 3 cm in the G-direction from
the alignment marker position (add to current position) on the Catphan® CTP503.
2 Make a new patient ID and name it CAT - Spatial.
3 Make a new treatment name and name it Spatial.
4 Make a new field name and name it Spatial.
5 Click Acquire VolumeView™ image.
6 Select the CAT - Image Quality Spatial preset and acquire an image.
After the VolumeView™ acquisition is completed, reconstruction starts automatically.
7 Click Accept.
8 Click the View Reconstruction button.
9 In the Slice Averaging list, select 3 slices.
10 In the Transverse image area, go to the spatial resolution module.

Note: This is usually slice number 32 for the Catphan® CTP 503.

11 Use the PAGE UP key, and count the slice number where the spatial resolution module does
not appear. Record the value in Table 2.5.
12 Use the PAGE DOWN key and count the slice number where the spatial resolution module
does not appear. Record the value in Table 2.5.
13 Select the slice in the middle of the recorded range of slices.
14 Zoom in or zoom out of the image until the spatial resolution module fills the image area.
15 Hold down the W key and move the pointer on line pair 10 until you get the best brightness
and contrast. For Catphan® CTP 503 (see Figure 2.11).

2
1

002709_001

Figure 2.11 Spatial resolution - Catphan® CTP 503 - Transverse view

(1) Line pair 1 (2) Line pair 10

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16 Record the highest number line pair that you can see in Table 2.5.
17 Select Dismiss
This closes the VolumeView Reconstruction window.

Table 2.5 Spatial resolution test results

Results
Slice number step 11 30
Slice number step 12 42
Spatial resolution (lp/cm) 12

Flamarion Digitally signed by Flamarion

Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart


Barbosa Goulart
Date: 2020.09.22 15:13:40
-03'00'

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2.1.5 Doing a test of the 3D transverse vertical scale

This test shows that the 3D transverse vertical scale is in specification.

Specification 117 mm ±1.0 mm (tolerance is equivalent to ±4 pixels)

1 Make sure that the S20 collimator and the F0 filter cassettes are in the kV source arm.
2 To align the treatment table in the G-T direction and set up the Catphan® phantom, do one
of the steps that follow.
a Align the treatment table from the G-end to the third alignment marker on the
Catphan® phantom. This alignment marker is applicable to a Catphan® CTP 503.
b If you have a license for RATM, move the treatment table 4 cm from the third
alignment marker position in the G-direction (add to current position).
3 Make a new patient ID and name it CAT - Geometric.
4 Make a new treatment name and name it Geometric.
5 Make a new field name and name it Geometric.
6 Click Acquire VolumeView™ image.
7 Select the CAT - Image Quality Geometric preset and acquire an image.

Note: After the VolumeView™ acquisition is completed, reconstruction starts automatically.

8 Click Accept.
9 Click the View Reconstruction button.
10 In the Slice Averaging list, select 3 slices.
11 In the Transverse image area, go to the contrast resolution module. This is usually slice
number 120.
12 Move the pointer to align with the top edge of the upper air insert.
13 Hold down the ALT key and the mouse button and drag the pointer to the top edge of the
lower air insert.
14 Release the ALT key and the mouse button, and measure the distance between the two air
inserts (see Figure 2.12).

Note: VolumeView™ shows the values in centimeters.

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117 mm

Air

117 mm
LPDE Delrin

Air
016118_001

Figure 2.12 Measure the distance between the two inserts - Catphan® CTP 503
15 Multiply the value on the screen by 10 to get the result in millimeters. Record the result in
Table 2.6.

Table 2.6 Vertical measurement between two inserts

Distance between Air to Air inserts 116.8 mm

Flamarion Digitally signed by Flamarion

Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart


Barbosa Goulart
Date: 2020.09.22 15:14:41
-03'00'

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2.1.6 Doing a test of the 3D transverse horizontal scale

This test shows that the 3D transverse horizontal scale is in specification.

Specification 117 mm ±1.0 mm (tolerance is equivalent to ±4 pixels)

1 Load the reconstructed images from the test of the 3D transverse vertical scale.
2 In the Transverse image area, go to the contrast resolution module. This is usually slice
number 120.
3 Move the pointer to align with the left edge of the Delrin insert.
4 Hold down the ALT key and the mouse button and drag the pointer to the left edge of the
LDPE insert.
5 Release the ALT key and the mouse button, and measure the distance between the two
inserts.

Note: VolumeView™ shows the values in centimeters.

6 Multiply the value on the screen by 10 to give the result in millimeters. Record the result in
Table 2.7.

Table 2.7 Horizontal measurement between two inserts

Distance between Delrin and LDPE inserts 116.8 mm

Flamarion Digitally signed by Flamarion

Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart


Barbosa Goulart
Date: 2020.09.22 15:16:03
-03'00'

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2.1.7 Doing a test of the 3D sagittal geometric scale

This test shows that the 3D sagittal geometric is in specification.

Specification 110 mm ±1.0 mm (tolerance is equivalent to ±4 pixels)

1 Load the reconstructed images from the test of the 3D transverse vertical scale.
2 Open the Sagittal image area (see Figure 2.13).

Note: It is only possible to see the alignment marker lines in the isocenter slice.

110

NOT TO SCALE 002712 ©2011 Elekta Limited

Figure 2.13 VolumeView™ reconstruction window - Sagittal image area


3 In the Sagittalimage area, measure the distance between the first and fourth alignment
markers on the Catphan® phantom. For Catphan® CTP 503 (see Figure 2.14).

Note: VolumeView™ shows the values in centimeters.

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110 mm

NOT TO SCALE 000578 ©2013 Elekta Limited

Figure 2.14 Catphan® CTP 503 sagittal scale measurement (Distance of 110 mm)
4 If it is necessary, adjust the settings for contrast and brightness.
5 Multiply the value on the screen by 10 to give the result in millimeters. Record the value in
Table 2.8.

Table 2.8 3D Sagittal test results

Measurement Measured distance (mm)


Sagittal plane - distance between the first alignment
109.9
marker and the fourth alignment marker

Flamarion Digitally signed by Flamarion


Barbosa Goulart

Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart Date: 2020.09.22 15:16:34
-03'00'

2.2 Doing a test of the Table Move Assistant accuracy


These tests measure the accuracy of the TMA after a VolumeView™ registration.

Specification Image registration is ≤1.0 mm.

CAUTION 2.2
Do not rotate the gantry before you make sure that the path of the beam limiting device, kV
source arm, kV and MV detector arms is clear. If the path is not clear, a collision of the parts
and the treatment table can occur. If you ignore this caution, you can cause damage to the
equipment.
1 Do the setup for the tests.

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a Put the ball bearing in a position that is an offset by 15 mm of the isocenter in all three
axis.

NOT TO SCALE 001572 ©2011 Elekta Limited

Figure 2.15 Ball bearing phantom


b Extend the kV detector arm and the kV source arm to the correct position to do the
images.
c Move the kV detector arm to the small field of view (FOV).
d Make sure that the S20 collimator and F0 filter cassettes are in the kV source arm.
2 Do the XVI calculated shift test (Test 1).
a Complete the system interlocks and make sure that the treatment table is in isocentric
zero position.
b In XVI, select the patient Bill Ballbearing, treatment 1, and the kV images field.
c Make a new field and name it ATM test.
d Click Acquire VolumeView image.
e Select the CAT - Image Registration preset and acquire an image.
After the VolumeView™ acquisition is completed, reconstruction starts automatically.
f Click Accept to accept the reconstruction results.
g Manually move the white sphere in each of the three windows until they have the
same center as the virtual ball bearing. The virtual ball bearing is at the end of the
green tube in the Coronal and Sagittal image areas. Move the ball bearing to the center
of the green tube in the Transverse image area.
h Click Convert To Correction.
i Record the results in the XVI calculated shifts column (see Table 2.9).
j Click Accept.
k Type your name in the Approval dialog box, and then click OK.
The Table Move Assistant shows the results.

Note: The Table Move Assistant dialog box is set to one decimal point.

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l On the FKP, press and hold the ENABLE and TABLE ASU keys on the FKP to move the
treatment table to the new position.

Note: A tolerance of >35 mm on the Table Move Assistant automatically disables the TABLE ASU and
ENABLE keys on the FKP. It is then only possible to move the treatment table from the controls in
the treatment room (see the XVI Instruction for Use manual).

m Click Done to close the Table Move Assistant.


3 Do the corrections after movements test (Test 2).
a Complete the system interlocks and make sure that the treatment table is in isocentric
zero position.
b Click Acquire VolumeView image.
c Select the CAT - Image Registration preset and acquire an image.
After the VolumeView™ acquisition is completed, reconstruction starts automatically.
d Click Accept to accept the reconstruction results.
e Manually move the purple sphere in each of the three windows until they have the
same center as the virtual ball bearing. The virtual ball bearing is at the end of the
green tube in the Coronal and Sagittal image areas. Move the ball bearing to the center
of the green tube in the Transverse image area.
f Click Convert To Correction.
g Record the values in the XVI convert to corrections after move column (see Table 2.9).
h Make sure that the corrections are ≤1.0 mm in all directions.
i Click Accept.
j Type your name in the Approval dialog box.
k Click OK.
l Click Done to close the Table Move Assistant.

Table 2.9 Test results of VolumeView™ treatment table accuracy tests

XVI convert to
Manual XVI calculated shifts
Axis Direction corrections after Direction ≤ spec
offset (Test1)
move (Test 2)
cm mm cm mm
Lateral (X) 15 mm 1 0.48 A 0 0.1 A Y
Longitudinal (Y) 15 mm 1 0.47 G 0 0 - Y
Height (Z) 15 mm 1 0.48 U 0 0.7 D Y

Flamarion Digitally signed by Flamarion

Flamarion Barbosa Goulart


Barbosa Goulart
Accepted by: Signature: Barbosa Goulart Date: 2020.09.22 15:17:07
-03'00'

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2.3 Doing a test of the 3D Registration accuracy


These 3D registration tests measure the registration accuracy of the kV images to the MV
isocenter for compliance with the specification.

Specification Image registration is ≤ 1.0 mm

This test uses the results from the Table Move Assistant accuracy tests.

1 Make sure that the accuracy tests for the Table Move Assistant are completed.
2 Do the test for the 3D Registration accuracy.

2.3.1 Measuring VolumeView™ registration accuracy

1 Copy the Test 2 results from the VolumeView™ treatment table accuracy tests to the
applicable results table in the Results of registration accuracy measurement section.

Note: For IEC 61217, +Longitudinal = G-direction, +Lateral = B-direction, +Height = Up. For IEC
60601-2-1, +Longitudinal = G-direction, +Lateral = B-direction, +Height = Down.

2 Make sure that you record the direction of error, for example, 0.23 mm in the A-direction.

2.3.2 Measuring MV registration accuracy

Note: A license for IMRT is a prerequisite for this measurement. If you do not have an IMRT license,
acquire the images manually (see the XVI Installation Information manual).

1 Extend the kV and MV detector arms.


2 On the treatment control system (TCS), select Delivered Stored Beam.
3 Select kV Flexmap Cal.
4 Log on to iViewGT™ in Clinical Mode.
5 Make a new patient ID with eight IMRT segments. Give it the name XVI CAT - Registration, a
treatment ID of 1, and a field ID of 1.
6 Double click the field ID, set IMRT Segments to a value of 8.
7 Select Single Exposure.
8 Deliver the IMRT prescription.
9 Click Export Image to export the images from iViewGT™ to the XVI system.
10 Click Images for this field.
11 In the Image Field Format list box, select the .his from the list.
12 In the Image files field, browse to the folder on the XVI control cabinet
\service_mv_images.
13 Make a new folder with the same name as the field ID in step 5 .
14 Browse to the new patient ID in step 5 .
15 In the File name: field, type #.his.
16 Click Save.
The Export dialog box appears.

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17 Click OK.
The acquired IMRT images are exported to the specified folder.
18 On XVI, select the patient Bill Ballbearing, treatment 1, and field kV images.
19 Select Service > kV Service Functions > Flexmap Functions > Full Flexmap Calibration.
20 Do the on screen wizard instructions until the Isocenter Location window opens.
21 Click Repeat Scan.
22 Click Next.
The Movement Instruction wizard opens.
23 Record the values in the Movement Instruction wizard in the MV registration accuracy
table. Make sure that you record the direction of error. For example, 0.5 mm to A.
24 Click Cancel to close the Full FlexMap Calibration wizard.
25 Make sure that the MV registration accuracy tests are ≤1.0 mm.
26 Calculate the difference between the kV and MV registration accuracy results. Record the
result in the Difference between kV & MV column). Make sure that you record the direction
of the difference correctly.

Note: The VolumeView™ values are in centimeters and the MV values in millimeters.

27 Make sure that the difference between the kV and MV registration accuracy values are
≤ 0.5 mm.

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Doing a test of the 3D Registration accuracy

2.3.3 Results of registration accuracy measurements

Note: VolumeView™ show the isocenter values in centimeters and the MV system values in millimeters.
Make sure that you multiply the VolumeView™ values by 10 to get the results in millimeters.

Table 2.10 kV registration accuracy measurements

Axis XVI calculated movement (mm)


Lateral (X) 0.1
Longitudinal (Y) 0.0
Height (Z) 0.7

Table 2.11 MV registration accuracy measurements

Axis XVI calculated movement (mm) Directions: A or B, G or T, Up or


down
Lateral (X) 0.05 B
Longitudinal (Y) 0.4 T
Height (Z) 0.91 D

Table 2.12 Results and difference between kV and MV registration accuracy measurements

Axis kV registration ≤ spec MV registration ≤ spec Difference


accuracy (mm) (Y/N) accuracy (mm) (Y/N) between kV &
MV (mm)
Lateral (X) 0.1 Y 0.05 Y 0.05
Longitudinal (Y) 0.0 Y 0.4 Y 0.4
Height (Z) 0.7 Y 0.91 Y 0.21

Note: For IEC 61217, +Longitudinal = G-direction, +Lateral = B-direction, +Height = Up. For IEC
60601-2-1, +Longitudinal = G-direction, +Lateral = B-direction, +Height = Down.
Digitally signed by Flamarion
Flamarion
Flamarion Barbosa Goulart Barbosa Goulart
Accepted by: Signature: Barbosa Goulart Date: 2020.09.22 15:17:38
-03'00'

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Doing a test of the 2D Geometric accuracy

2.4 Doing a test of the 2D Geometric accuracy


This test is to show that the display center of the acquired static 2D kV image identifies the MV
radiation isocenter.

Specification ≤ 4 pixels at isocenter (≤ 1.0 mm )

1 Put the single ball bearing at the isocenter for MV.


2 Select the patient, treatment 1, and create a new field and name it 2D Geometric.
3 Click Acquire PlanarView image.
4 Select the CAT - 2D Geometric preset.
5 Acquire four PlanarView™ images with the gantry at 180°, 90°, 0° and -90°.
6 Click the Show Center button, and zoom in to 400%.
7 Select an image, and then select Tools > Service > Display Pixel Factor Information.
8 Move the pointer to the center of the ball bearing and record the X and Y coordinate values
in Table 2.13.
9 Move the pointer to the center of the purple cross (image center) and record the X and Y
coordinate values in Table 2.13.
10 Do steps 7 to 9 again for each of the other images. Record their values in Table 2.13.

Table 2.13 Distance from cross to ball bearing center

Difference Image
Image Gantry
Ball bearing center Image center center and ball
number angle (°)
bearing center
X Y X Y X Y
1 180º 518 510 518 509 0 1
2 90º 519 514 518 513 1 1
3 0º 518 511 517 510 1 1
4 -90º 515 509 515 507 0 2

Note: The values measured must be ≤ 4 pixels.

Flamarion Digitally signed by Flamarion

Accepted by: Flamarion Barbosa Goulart Barbosa Goulart


Signature: Barbosa Goulart Date: 2020.09.22 15:18:05
-03'00'

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Doing a test of the 2D imaging system

2.5 Doing a test of the 2D imaging system


2.5.1 Doing a test of the 2D low contrast visibility

This test is to show the 2D low contrast visibility of the full X-ray imaging chain.

Specification A minimum of 12 discs

1 Warm up the X-ray tube and make sure that it is at the correct temperature.
2 Put the TOR 18FG Leeds phantom (2) on the carbon fiber table top at the isocenter at 45° to
the room lasers. The top of the phantom is at isocenter (see Figure 2.16).

45º
1

001550 ©2011 Elekta Limited

Figure 2.16 Phantom and plate position

(1) 1 mm CU plate (2) TOR 18FG


3 Put the 1 mm copper (Cu) plate (1) on top of the TOR 18FG Leeds phantom (2).
4 Rotate the gantry to -90°.
5 Make sure that the S20 collimator and F0 filter cassettes are in the kV source arm.

Note: Make sure that the phantom is approximately at 45° to the room lasers (see step 2 ).

6 Make a new patient with the name CAT- 2D.


7 Make a new treatment with the name 2D.
8 Make a new field with the name 2D.
9 Click Acquire PlanarView.
10 Select the CAT - 2D Geometric preset and acquire an image.
11 Adjust the brightness and contrast until the two disks are clearly in view in the squares (1)
and (2) (see figure below).

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5 A

B
3
NOT TO SCALE 002714 ©2011 Elekta Limited

Figure 2.17 X-ray image of TOR 18FG phantom

(1) Low contrast marker no. 7 (4) Brightness indicator


(2) Contrast indicator (5) Resolution grid
(3) Low contrast marker no. 12
(A) Low contrast markers 1-9 (B) Low contrast markers 10-18
12 Count the numbers of low contrast disks you can see of the total 18 disks (see Table 2.14).

Note: The more disks you can see, the better the low contrast visibility is.

Table 2.14 Low contrast disks

First series of low contrast disks 1-9 (A)


1 2 3 4 5 6 7 8 9
16% 14.50% 12.30% 10.80% 8.60% 7.60% 6.60% 5.50% 4.50%
Second series of low contrast disks 10-18 (B)
10 11 12 13 14 15 16 17 18
3.90% 3.30% 2.70% 2.30% 1.80% 1.60% 1.35% 1.15% 0.90%
13 Make sure that the number of disks you can see is in compliance with the specification.
Record the results in Table 2.15.

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Table 2.15 Low contrast disk test results

Number of disks visible 16

Digitally signed by Flamarion


Flamarion
Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart
Barbosa Goulart
Date: 2020.09.22 15:18:39
-03'00'

2.5.2 Doing a test of the 2D Spatial resolution

This test shows that the 2D spatial resolution is in specification.

Specification A minimum of the 10th group (1.4 lp (line pairs)/mm)

1 Load the image from the test of the 2D Low contrast visibility.
2 Set the brightness and contrast so that you see the two disks clearly in the squares (1) and
(2) (see Doing a test of the 2D Low contrast visibility).
3 Adjust the quality of the image until you can see the brightness and contrast boxes.
4 Monitor the resolution grid and count the number of spatial frequency groups that you can
see clearly (see Figure 2.18).

Note: A frequency group is a group of five bars. Count the frequency groups from the left column, and in
each column from the top down.

Count

NOT TO SCALE 002715 ©2011 Elekta Limited

Figure 2.18 Visible frequency groups


5 Record the number of frequency groups counted in Table 2.17.

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Table 2.16 Group table in lp/mm of the TOR 18FG Phantom

Number of resolved groups - spatial resolution in lp/mm


(1) 0.5 (4) 0.71 (7) 1.0 (10) 1.4 (13) 2.0 (16) 2.8 (19) 4.0
(2) 0.56 (5) 0.8 (8) 1.12 (11) 1.6 (14) 2.24 (17) 3.15 (20) 4.5
(3) 0.63 (6) 0.9 (9) 1.25 (12) 1.8 (15) 2.5 (18) 3.55 (21) 5.0

Table 2.17 Spatial resolution test results

Number of frequency groups visible 13

Digitally signed by
Flamarion
Accepted by: Flamarion Barbosa Goulart Signature: Barbosa Goulart Date:
Flamarion Barbosa Goulart
2020.09.22 15:19:10
-03'00'

Customer notes & comments:

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XVI Tests
Certificate of Acceptance

2.6 Certificate of Acceptance

The installation and commissioning of the Elekta products were completed. The applicable tests in the customer
acceptance test plan were completed in compliance with the specification. A user manual (Instructions for Use)
was supplied.

Serial No. of the linear accelerator: 109119

Serial No. of the Precise Treatment Table™: 229281

Serial No. and type of beam limiting device: 280059

Serial No. of iViewGT™ system: 1 302805

Serial No. of XVI system: 1 337216

Precise Digital Accelerator (Precise Treatment System™) ✔ Elekta Infinity™


Elekta Synergy® Platform Versa HD™
Elekta Synergy® Elekta Axesse™

Hospital
ACCG - Hospital Araujo Jorge

Address
Rua 239, n. 206 Setor Universitario

Country
Brazil

Flamarion Digitally signed


by Flamarion
Barbosa Barbosa Goulart
Name: Flamarion Barbosa Goulart Signature: Date: 2020.09.22
Goulart 15:20:32 -03'00'
Date: Sep 22, 2020 Hospital Representative
Thales Monteiro Digitally signed by Thales
Name: Thales Macieira Signature: Macieira Monteiro Macieira
Date: 2020.09.22 15:19:51 -03'00'

Date: Sep 22, 2020 Elekta Representative

If the Customer Acceptance Tests are completed using an electronic Customer Acceptance Tests (CAT) document,
upload the approved electronic document to the Elekta Customer Lifecycle Management (CLM) system for
equipment registration.
For Customer Acceptance Tests using hardcopies, the BU or Distributor keeps two copies, and the customer keeps
one copy. A copy of the approved Certificate of Acceptance is uploaded to the CLM for equipment registration.

1 This is not the serial No. of the control cabinet. The serial No. for the system can be downloaded from CLM.

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Certificate of Acceptance

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