Philips MX 16 Instruction Manual

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MX 16-slice

P e r f o r m a n c e T e s t I n s t r u c t i o n s

4550 193 03381 Revision C

This document and the information contained in it is proprietary and confidential information of Philips Healthcare ("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Philips Legal Department. Use of this document and the information contained in it is strictly reserved for current Philips personnel and Philips customers who have a current and valid license from Philips for use by the customer’s designated in-house service employee on equipment located at the customer’s designated site. Use of this document by unauthorized persons is strictly prohibited. Report violation of these requirements to the Philips Legal Department. This document must be returned to Philips when the user is no longer licensed and in any event upon ’Philips first written request.

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Symbol Descriptions

Attention symbol Radiation warning symbol

Laser warning symbol Biohazard warning symbol

Magnetism warning symbol Projectile warning symbol

Electrical warning symbol Do not touch

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Revision History

ECO # Revision Date Comments

H3002508 A July 2009 New Release

E-007395 B May 2010

E-130676 C July 2020 Updated NOTE on page 12

This document was prepared by the CT/NM Service Innovation. For any additions, corrections, or suggestions, contact your next level of support.

Modified Performance Test Criteria

Matrix on page 2

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Safety Information

To the User of This Manual

The user of this manual is directed to read and carefully review the instructions, warnings and cautions contained herein prior to beginning installation or service activities. While you may have previously installed or serviced equipment similar to that described in this manual, changes in design, manufacture or procedure

may have occurred which significantly affect the present installation or

Installation and Environment

Except for installations requiring certification by the manufacturer per federal standards, see that a radiation protection survey is made by a qualified expert in accordance with NCRP 102, section 7, as revised or replaced in the future. Perform a survey after every change in equipment, workload, or operating conditions

which might significantly increase the probability of persons receiv

Diagnostic Imaging Systems - Mechanical-electrical Warning

All of the moveable assemblies and parts of this equipment should be operated with care and routinely inspected in accordance with the manufacturer’s recommendations contained in the equipment manuals. Only properly trained and qualified personnel should be permitted access to any internal parts. Live electrical terminals are deadly; be sure line disconnects are opened and other appropriate precautions are taken before opening access doors, removing enclosure panels, or attaching accessories.

Do not under any circumstances, remove the flexible high tension cables from the x-ray tube housing or high tension generator and/or the access covers from the generator until the main and auxiliary power supplies have been disconnected. Failure to comply with the above may result in serious or fatal bodily injuries to the

operator or thos

e in the area.

Electrical-grounding Instructions

The equipment must be grounded to an earth ground by a separate conductor. The neutral side of the line is not to be considered the earth ground. On equipment provided with a line cord, the equipment must be connected to properly grounded, three-pin receptacle. Do not use a three-to-two pin adapter.

service.

ing more than the maximum permissible dose equivalent.

Diagnostic Imaging Systems - Radiation Warning

X-ray and Gamma-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures are strictly observed.

The useful and scattered beams can produce serious or fatal bodily injuries to any persons in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to leakage radiation from within the source housing or to scattered radiation resulting from the passage of radiation through matter.

Those au established safe exposure factors and procedures described in publications, such as: Subchapter J of Title 21 of the Code of Federal Regulations, "Diagnostic X-ray Systems and Their Major Components", and the national council on radiation protection (NC Up To 10 Mev-equipment Design and Use", as revised or replaced in the future.

Those responsible for planning of x-ray and gamma-ray equipment installations must be thoroughly familiar and comply completely with NCRP no. 49, "Structural Shielding Design and Evaluation For Medical Of X-rays and Gamma-rays of Energies Up to 10 Mev", as revised and replaced in the future. Failure to observe these warnings may cause serious or fatal bodily injuries to the operator or those in the area. Add additional safety information as needed

thorized to operate, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the current

RP) no. 102, "Medical X-ray And Gamma-ray Protection For Energies

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MX 16-slice Performance Test Instructions Revision C

Contents

MX 16-slice Performance Manual .................................................................................................... 1

Introduction ............................................................................................................................................................ 1

Scope................................................................................................................................................................ 1

Overview ................................................................................................................................................................1

Equipment Required .........................................................................................................................................2

Performance Test Criteria Matrix...................................................................................................................... 2

Safety .....................................................................................................................................................................4

Prerequisites for Performance Testing................................................................................................................... 5

Automatic Tests ..................................................................................................................................................... 6

Position the System Test Phantom................................................................................................................... 6

Start the Automatic Test ...................................................................................................................................7

Automatic Performance Test ............................................................................................................................8

Before Beginning the Automatic Performance Test ....................................................................................8

Automatic Acceptance Test ............................................................................................................................14

Automatic Constancy Test.............................................................................................................................. 17

Automatic QA Test.......................................................................................................................................... 18

Appendix A: System Test Phantom ............................................................................................... 20

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MX 16-slice Performance Test Instructions

MX 16-slice Performance Manual

Introduction

This document provides system performance tests, test methods, and performance specifications for the MX 16-slice System. Personnel using this document and performing these tests are expected to be familiar with CT system test methods and the operation of the MX 16-sliceSystem. A MX 16-slice System meeting these performance specifications is a necessary but not sufficient condition for acceptable system performance and acceptable image quality for system shipment to customers and subsequent clinical use.

Scope

This document applies to all completely assembled and fully calibrated MX 16-slice CT Systems.

Overview

MX 16-slice Performance

The purpose of the Performance, Constancy, Acceptance and QA tests are as follows:

• Performance Test

Run this test after major component replacement such as, X-ray tube or DAS. This tests the general image quality of the scanner.

• Acceptance Test

The Acceptance test is run in the field for the newly installed scanner or if major changes were made in the scanner version and/or scanner hardware. The result obtained during the Acceptance test is the base line for the next Constancy test.

• Constancy Test

The Constancy test is run during Planned Maintenance or component replacement. Constancy measures the performance and stability of the system relative to the results received in the Acceptance test.

• QA Test

The QA test runs scans to compare the CT numberm Uniformity, and Noise of the scan wiht the allowed tollerance.

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MX 16-slice Performance Test Instructions

Equipment Required

System Test Phantom 455012001021

Performance Test Criteria Matrix

Table 1 lists the Performance tests required when performing the listed procedures.

Follow the instructions in this manual for the performance tests indicated in the table.

Procedure Performance Constancy Acceptance

MX 16-slice Performance

Table 1:

New system Installation

Site System Installation

X-ray tube replacement

HV Generator replacement

Ref. Detector replacement

A-Plane Replacement

Z Position Detector Board Replacement

Central six ADM Replacement

Single ADM replacement

Compensator Replacement

Reference Converter Board Replacement

DMS Replacement

Slice Thickness Detection Board Replacement

Y Y

Planned Maintenance

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Y Y

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MX 16-slice Performance Test Instructions

NOTE If the Constancy test fails, repeat the Acceptance test.

MX 16-slice Performance

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

Safety

WARNING collision hazard! when mounting the phantom make sure that it is positioned so that it

will not come in contact with the gantry covers or the rotor.

WARNING Close all Gantry covers before performing tests. Check that the temperature regulation

of the gantry and the DMS function properly. wait for the temperature to stabilize

within ±2 ℃ .

CAUTION Ensure that the phantom is completely vertical (Tilt = 0) before performing any calibration or

performance tests; tilt or misalignment of the phantom may result in inaccurate calibration and performance tests.

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MX 16-slice Performance Test Instructions

Prerequisites for Performance Testing

1. All operating software has been installed and Auto-Calibration has been successfully completed.

2. The system is fully functional with all hardware and software calibrations complete and performs according to

specification. All covers must be in place and securely attached. All other safety covers or switches must be in their normal operating positions or states unless specifically changed by a test procedure.

MX 16-slice Performance

3. The X-ray tube must be warmed up to a nominal tube heat (20%) be

fore starting the test and all air calibrations

must be current.

4. The Gantry / Detector cooling system must be fully functional, and must maintain normal and stable temperatures. The normal DMS (Data Measurement System) operating temperature is 32 ±2°C. It is important to maintain temperature stability within ±2°C between calibration and image performance testing in order for the test results to be valid.

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MX 16-slice Performance Test Instructions

Automatic Tests

Position the System Test Phantom

To launch the Automatic Tests described in this manual, position the System Phantom according to the following procedure.

1. Position the System Phantom at the head of the Patient Table using the Phantom Holder.

2. Manually control the height of the Patient Table so that the outside laser marker is set to the center of the Phantom

(see Figure 1

MX 16-slice Performance

3. Manually move the Patient Table Top so that the Inner Laser Marker set to the water layer (see Figure 2

Figure 2: Upside

Figure 1: Lateral Side

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MX 16-slice Performance Test Instructions

Start the Automatic Test

1. Insert the IST key, and log On the IST.

2. Double click the MX 16-slice icon on desktop, and log On as ctsoft(ctsoft).

3. Warm up the X-Tube to 20%.

4. From the main menu, click Service, select the Advanced Service tab, select Performance, and perform the

Automatic Tests in the following order:

• Automatic Performance Test on page 8

• Automatic Acceptance Test on page 14

• Automatic Constancy Test on page 17

• Automatic QA Test on page 18

NOTE During performance tests, verify that the images are free of rings and other artifacts.

MX 16-slice Performance

Figure 3: Automatic Tests Process

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MX 16-slice Performance Test Instructions

Automatic Performance Test

The Automatic Performance Test runs scans of different types to check the performance of the system, the full test performs 16 scans in different modes and takes approximately 15 minuntes to complete.

Before Beginning the Automatic Performance Test

• The Automatic Performance tests scans the images automatically but does not check the individual scans for

rings, bands and artifacts; inspection of images MUST be performed by the FSE. No rings or bands are allowed on the image. Use a window width of 100 for Head and 150 for Body, with the window centered on the CT number of the material (e.g. 0 for Water).

• For all Scans: If a scan in any mode fails with comply to specified tolerances, repeat the scan manually using

the same parameters and verify that the results are correct. The SD and CT tolerance values may change during the lifetime of the system.

NOTE If the error message” Tube Power Limit Exceeded” is displayed, wait until the tube cools down and try running the

scan again.

MX 16-slice Performance

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MX 16-slice Performance Test Instructions

Run the Automatic Performance Test according to the following procedure:

1. In Auto-performance dialog box, highlight Performance (see Figure 3 Next.

2. In the Config Information dialog box, enter the

required information.

• Machine SN

• Customer Name

• Customer Address

• Phantom SN

• Aculon CT Number

• FSE Name

NOTE The recommended Aculon CT

MX 16-slice Performance

on page 7), and click

Numer is 100.

3. Click OK.

Figure 4: Config Information

4. An Instructions dialog box opens (see Figure 5 on page 10). Follow the on-screen instructions to positon the System Phantom, and once it is in position, click OK to continue.

a. Mount the System Phantom to the Phantom Support. The Phantom must be level.

b. Set the laser beam to the Water Layer of the Phantom.

c. Adjust the System Phantom in the center of the Gantry.

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

Water Layer

Figure 5: Position Phantom Instruction

Make

5. In the following dialog boxes click Start to select the desired items (see Figure 7

on page 10).

6. Select the desired items and click Next to continue the Performance test.

Figure 6: Water Layer (to be updated)

Figure 7: Select the desired items

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

WARNING Make sure there is no one in scanner room, and the scanner room door is closed.

7. Click OK to continue.

8. The application scans the System Phantom and calculates the position of the System Phantom.

If the position is not accepted, the application provides instructions to adjust the position of the Phantom.

9. When the System Phantom position is accepted, the system will automatically start the Performance Test scan (see

Figure 8

on page 11).

Figure 8: Verify Items

The test automatically runs a sequence of scans. The scans and scan parameters are listed in Verify Item area.

10. When the image quality of each item is found to comply with the required tolerances its State is recorded in green as Passed as shown in Figure 8

on page 11. When the image quality of an item fails to comply with any required

tolerance its State is recorded in red as Failed.

11. When the Auto-performance test is complete, an Auto-performance report is generated automatically and saved on the disk.

12. Click Report to view the test results (see Figure 9

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on page 12).

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MX 16-slice Performance Test Instructions

NOTE If any of the sub-items failed during the Auto-performance test, repeat the same sub-item or perform it again

manually.

MX 16-slice Performance

Figure 9: Performance Report (Example)

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MX 16-slice Performance Test Instructions

Exception: when any of the Teflon CT value failed during the Auto-performance test, please ignore if it is in the

range of 900-1100HU.

MX 16-slice Performance

Figure 10: Example

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MX 16-slice Performance Test Instructions

Automatic Acceptance Test

Run the Automatic Acceptance Test according to the following procedure:

1. In the Auto-performance dialog box, highlight Acceptance (see Figure 3 Next.

2. In the Config Information dialog box, enter the

required information (see Figure 11

• Machine SN

• Customer Name

• Customer Address

• Phantom SN

• Aculon CT Number

• FSE Name

• Reason

MX 16-slice Performance

on page 7), and click

on page 14).

NOTE The recommended Aculon CT

Numer is 100.

3. Click OK.

Figure 11: Config Information

4. An Instructions dialog box appears. Follow the on-screen instructions to positon the System Phantom, and once it is in position, click OK to continue.

5. In the following window, click Start to select the desired items, and click Next to continue the Acceptance test.

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

WARNING Make sure no one is in the scanner room, and the scanner room door is closed.

6. Click OK to continue.

7. The application scans the System Phantom and calculates the position of the System Phantom.

If the position is not accepted, the application will provide instructions for adjusting position of the Phantom.

8. When the System Phantom position is accepted, the system will automatically start the Acceptance Test scan.

The test automatically runs a sequence of scans and the scans and parameters are listed in Verify Item area.

9. When the image quality of each item is found to comply with the required tolerances its State is recorded in green as Passed. When the image quality of an item fails to comply with any required tolerance its State is recorded in red as Failed.

10. When the Auto-acceptance test has completed, an Auto-acceptance report is generated automatically and saved.

11. Click Report to view the test results (see Figure 12

on page 16).

NOTE If any of the sub-items failed during the auto-Acceptance test, repeat the same sub-item or perform it again

manually.

12. When all the items passed and the measurements are within the required ranges, a baseline is automatically saved.

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

Figure 12: Acceptance Report (Example)

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MX 16-slice Performance Test Instructions

Automatic Constancy Test

Run the Automatic Constancy Test according to the following procedure:

MX 16-slice Performance

1. In the Auto-performance dialog box, highlight Constancy (see Figure 3

2. Follow Step 2

on page 14 to Step 9 on page 15 of the Automatic Acceptance Test on page 14.

on page 7), and click Next.

3. When the Auto-constancy test is complete, an Auto-constancy report is generated automatically and saved. Click Report to view the test results (see Figure 13

on page 17).

NOTE If any of the sub-items failed during auto-Constancy test, repeat the same sub-item or perform it again manually.

Figure 13: Constancy Report (Example)

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MX 16-slice Performance Test Instructions

Automatic QA Test

Run the Automatic QA Test according to the following procedure:

MX 16-slice Performance

1. In the Auto-performance dialog box, highlight QA (see Figure 3

2. Follow Step 2

on page 14 to Step 9 on page 15 of the Automatic Acceptance Test on page 14.

on page 7), and click Next.

3. When the QA Test has completed, a QA Test report is generated automatically and saved. Click Report to view the test results (see Figure 13

on page 17).

NOTE If any of the sub-items failed during QA test, repeat the same sub-item or perform it again manually.

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MX 16-slice Performance Test Instructions

MX 16-slice Performance

Figure 14: QA Test Report

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MX 16-slice Performance Test Instructions

Appendix A: System Test Phantom

The test phantom used for the majority of these tests is the System Performance Phantom. This phantom is supplied as part of every MX 16-slice system. The phantom consists of a combined Head and Body Phantom. The Head Phantom is a 200 mm diameter PVC shell filled with distilled water. The Head Phantom has three sections (see detailed description of the system phantom in Figure 15

1. The physics layer is used for impulse response and tomographic section thickness (slice width) measurements.

2. The water layer is used to measure uniformity and noise.

3. The Multi–Pin Layer is used for low contrast scale check.

The Body Phantom part of this phantom consists of a water hole (0 ±10 CT) and air (1000 ±10 CT).

System Test Phantom

on page 21–Figure 18 on page 24.

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MX 16-slice Performance Test Instructions

Large Field (300 mm) Section

Small Field (250 mm) Section

(

)

t i

116 mm

60 mm

Centering

(25 mm

OD)

33 mm

Oblique View

System Test Phantom

Figure 15:

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MX 16-slice Performance Test Instructions

Aluminum (Slice Width) Layer

Water Layer

Multipin Layer

Small Field (250 mm) Section

is filled with water

Large Field (300 mm) Section

is filled with Aculon

Centering

Mounting

Clamp

Handle

Lexan

Ramp

Locator

Spatial Phantom

Low Contrast Phantom

Slice Width Ramp

Teflon pin

Ramp

Locator

Point Spread Function Phantom

(0.18 mm copper wire)

Water pin is

behind the

Teflon pin

Aculon

Perspex

Left Side View

System Test Phantom

Figure 16:

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MX 16-slice Performance Test Instructions

Large Field (300 mm OD) Section

Small Field (200 mm OD) Section

Spatial Phantom,

Perspex (|130 ± 15) with Lexan pins

Low Contrast Phantom,

Aculon (|100 ± 15) with Lexan pins

6 mm

3 mm

5 mm

2 mm

7 mm

4 mm

Aluminum

Slice

Width

Ramp

Polyethelyene

(|-60 ± 15)

Perspex

(|130 ± 15)

Teflon

(|950 ± 50)

Lexan

(|110 ± 15)

Centering

Point Spread Function Phantom

(0.18 mm copper wire)

aluminum strip at 45° to horizontal

Note: Aculon = nylon Perspex = acrylic

1 of 4 Ramp

Locators

Teflon

in Large Field Sec

(|950 ± 50)

Water

in Large Field Section

(0 ± 10)

System Test Phantom

Figure 17:

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MX 16-slice Performance Test Instructions

Handle

Mounting Clamp

Water Fill

Full Field (300 mm OD) Section

Front View

System Test Phantom

Figure 18:

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MX 16-slice Performance Test Instructions

Table 2:

Pin Number Description

1 Nylon (Aculon) body with six smaller Lexan pins of 3 mm, 4 mm, 5 mm, 6 mm, 7 mm and 8 mm diameter.

2 Polyethylene

3 Teflon

4 Perspex with seven rows of holes of different diameters. Each row has five equidistant holes of the same

diameter, as follows:

Row 1 1.00 mm holes, 2.00 mm apart

Row 2 1.25 mm holes, 2.50 mm apart

Row 3 1.50 mm holes, 3.00 mm apart

Row 4 1.75 mm holes, 3.50 mm apart

System Test Phantom

Row 5 2.00 mm holes, 4.00 mm apart

Row 6 2.50 mm holes, 5.00 mm apart

Row 7 3.00 mm holes, 6.00 mm apart

5 Lexan

6 Perspex

Region 7 PVC (shell)

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