Gammex Doppler 403 Flow Phantom Manual
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Gammex Doppler 403 Flow Phantom Manual

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Title
Doppler 403
Flow
TM
Phantom
Model 1425B

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Summary of Contents for Gammex Doppler 403 Flow Phantom

  • Page 1 Title Doppler 403 Flow Phantom Model 1425B...
  • Page 2 User’s Guide, Doppler 403™ Flow Phantom © 2016 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 writ- ten consent of Gammex Inc.

  • Page 3: Preface

    Gammex meets worldwide standards including EN ISO 13485, FDA 21 CFR 820, and IEC 60601-1. 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.

  • Page 4: Regulatory Information

    Finding Additional Information For more information about the Doppler 403 Flow Phantom, refer to the Gammex website — www.gammex.com. Visit the website for the latest product information and product updates. Document Conventions Bold typeface indicates a button name or something that the user must type.

  • Page 5: Table Of Contents

    Introduction ......1 Caring for the Doppler 403 Flow Phantom ..23 Description .
  • Page 6 This page is intentionally left blank. Contents...

  • Page 7: Introduction

    The phantom has horizontal and diagonal vessel orientations, and includes test objects for both Doppler and B-mode assessments. As a B-Mode phantom the Doppler 403 Flow Phantom meets all ACR, and AIUM requirements for acceptance testing as well as for biannual and annual system performance evaluation and routine quality control tests.

  • Page 8: Accessories

    Accessories The following Doppler 403 Flow Phantom replacement parts are available. Part Number Description xxxxxx Scanning window cover xxxxxx Replacement screws for scanning window cover Phantom Assembly The phantom assembly consists of a target array with tissue-mimicking materials and vessels, and a flow system with a pump and flow controller used to circulate blood-mimicking fluid.

  • Page 9: Flow System

    Doppler QA. The vessel inner diameter is 0.5 cm, and the fluid is pumped through the vessel at user-selectable rates. Phantom Top Panel Figure 1-3 shows the Doppler 403 Flow Phantom top panel features. Control panel Diagonal...

  • Page 10: Sono Transducer Holder

    Sono Transducer Holder A Sono Transducer Holder is included with each Doppler 403 Flow Phantom (Figure 1-1 on page 1). The holder enables precise transducer placement for consistently reproducible QA tests. See the Sono Transducer Holder User’s Guide located on the Ultrasound CD or memory stick for...

  • Page 11: Operation

    (20 – 25 °C) before powering on. Before starting a QA scanning session: Place the Doppler 403 Flow Phantom on a stable, level surface and turn power on. Remove the scanning surface cover. Select the appropriate imaging transducer for the test to be performed.

  • Page 12: Scanning For Color Flow Imaging

    Image plane projecting through horizontal Image plane projecting through diagonal Figure 2-1. Doppler 403 Flow Phantom B-Mode Images of Vessel Sections Scanning for Color Flow Imaging Refer to Appendix A: Flow Velocity Accuracy on page 27 for flow velocity theory and calculations.
  • Page 13 • Flow is towards the transducer on the right side of the color image and away from the transducer on the left side of the image. • Color changes from right to left due to sensitivity of the displayed velocity to the beam angle, which changes across the vessel in this example because a sector transducer was used.

  • Page 14: Scanning With Doppler Signals

    Scanning with Doppler Signals When setting up for Doppler signal imaging: • A linear array transducer performs best for beam steering tests. • Use a small sample volume (gate) placed as closely as possible to the middle of the vessel. Perform the scan: Using the same scanning plane orientation used in Scanning for Color Flow Imaging on page 6, place transducer on phantom.

  • Page 15: Doppler Qa

    Doppler QA This section provides information for using the Doppler 403 Flow Phantom for Doppler signal tests as part of a complete ultrasound system evaluation. When qualifying any medical device, the Quality Control test suite must comply with all local regulations and the testing facility’s Quality System.

  • Page 16: Depth

    Color Flow Sensitivity and Penetration Depth This test determines the maximum depth at which usable color flow information is received. Perform the test: Set the phantom to CONTINUOUS or PULSE mode with a mid-range flow rate (5–7 ml/s). Wait a few seconds for flow to reach the selected rate. Record the mode and rate.

  • Page 17: Directional Discrimination

    Set the phantom to CONTINUOUS mode with a low (1–2 ml/s) flow rate. Record the mode and rate. On the ultrasound system, set the color flow output power and color gain for maximum sensitivity without excessive noise. Scan the diagonal vessel. Toggle between color flow and B-mode.

  • Page 18: Flow Velocity Profiles

    In the Doppler 403 Flow Phantom, following any bending of the tube (vessel), a parabolic flow profile is achieved after an “entrance length” that is proportional to the Reynolds number in the fluid and the vessel’s inside diameter.

  • Page 19: Flow Velocity Accuracy

    Table 3-1, column 5, Entry Length (cm), provides the calculated entrance lengths required to achieve parabolic flow at 22 °C for the blood-mimicking fluid inside the vessel, which has a density of 1.03 g/cc, a viscosity of 4.1 cP, and an inside diameter of 0.5 cm. As shown in the table, for a flow rate of 6 ml/s, parabolic flow conditions are achieved after about 10.54 cm.

  • Page 20: Sample Gate Positioning Accuracy

    If available, set the ultrasound system to display a curve that shows TAMAX (a continuous estimate of the maximum velocity on the spectral display), and TAMEAN (a continuous estimate of the mean velocity on the spectral display). Reduce the sample volume gate to 2 mm, and position the gate so that it is centered on the horizontal vessel axis.

  • Page 21: 2D B-Mode Qa

    2D B-Mode QA This section provides information for using the Doppler 403 Flow Phantom for B-Mode imaging in 2D and 3D ultrasound systems, as part of a complete ultrasound system evaluation. When qualifying any medical device, the Quality Control test suite must comply with all local regulations and the testing facility’s Quality System.

  • Page 22: Image Uniformity And Transducer Integrity

    Image Uniformity and Transducer Integrity This series of tests evaluates image uniformity and checks for transducer element damage or weakness. If non-uniformities are observed, before recording results, verify the results are reproducible and not the result of poor transducer–phantom coupling. On the ultrasound system, select the transducer to be tested and adjust settings to optimize the image.

  • Page 23: Distance Measurement Accuracy

    Figure 4-3. Curvilinear Array Image Uniformity Test, Two Images Covering Entire Array Two images may be required to assess the entire array. In Figure 4-3 on page 17, note there is no evidence of dead elements in either image. Record the results on the B-Mode QC Test Data Sheet. If required, repeat steps using other transducers normally used with this scanning system.

  • Page 24: Lateral And Axial Resolution And Image Geometry

    Lateral and Axial Resolution and Image Geometry This test assesses resolution quality of a scanning array. Refer to Figure 1-2 on page 2 for phantom target location, depth and type. When performing this test: On the ultrasound system, select the transducer to be tested and set the beamformer speed of sound to 1540 m/s.
  • Page 25 Figure 4-7. Resolution Target Group at 4 cm Indicates Axial Resolution • Pin targets are resolved axially if an imaginary horizontal line can be drawn between the imaged targets on the scan, without touching either target image (Figure 4-8 on page 19). •...

  • Page 26: Gray Scale Display

    Gray Scale Display This section provides information for using the Doppler 403 Flow Phantom to asses the ultrasound system’s gray scale display as part of a complete ultrasound system evaluation. When qualifying any medical device, the Quality Control test suite must comply with all local regulations and the testing facility’s Quality System.

  • Page 27: Quantitative

    Save the image to the ultrasound system and to the PACS. Record the gain setting. View the images saved in steps on both the ultrasound system and the PACS display. Observe whether the same image features are seen on both the ultrasound system images and the PACS display.

  • Page 28: Dual Display Analysis

    Repeat steps – three times. Record the average echo level for each gray scale target and for the background material on the Quantitative Measurement test data sheet. Dual Display Analysis This test provides a qualitative assessment of the ultrasound system’s gray scale display using the dual mode display available on some ultrasound systems.

  • Page 29: Support And Maintenance

    Gammex offers annual rejuvenation and recertification services to further prolong the life of the phantom and to ensure continued proper operation. Rejuvenation and proper care will prolong the life of the phantom for many years, and ensure that it continues to meet Gammex specifications. See Contacting Gammex Technical Support on page 24.

  • Page 30: Charging The Battery

    Charging the Battery The flow pump and flow controls are powered with a 14.8 v Li-Ion battery. The battery must be charged using the Li-Ion battery charger supplied with the Doppler 403 Flow Phantom. The battery is not user-replaceable. Maintenance Repairs There are no user-repairable parts.

  • Page 31: Specifications

    Specifications Specifications Table 7-1. Doppler 403 Flow Phantom Specifications* Category Characteristic Specification Case Material Aluminum Dimensions (cm/in.) 28 x 30.5 x 22 (11 x 12 x 8.7) Weight kg (lb.) 8.34 (18.4) Tissue-mimicking Material Patented HE Gel™ material Speed of sound (m/s, ± 10)
  • Page 32 Table 7-1. Doppler 403 Flow Phantom Specifications* (Continued) Category Characteristic Specification Anechoic cylinders 9 cylinders 3 cylinders in 3 groups (low scatter cysts) Cylinder group depths (cm, ± 0.3) 4.0, 9.0, 14.0 Cylinder diameter/group (mm, ± 0.5) 2.0, 4.0, 6.0 Attenuation at low contrast 0.05...

  • Page 33: Appendix A: Flow Velocity Accuracy

    Appendix A: Flow Velocity Accuracy Flow Profiles in the Doppler 403 Flow Phantom Flow instruments produce physiological flow rate levels used to perform a full range of quality and acceptance tests. Flow phantoms provide a realistic signal environment as a spectrum of velocities is produced across the flow profile of a simulated vessel.

  • Page 34: Mean And Maximum Velocity Calculations

      0.06 Table 3-1 on page 13 provides L values for peak velocities in the Doppler 403 Flow Phantom, up to 122 cm/s. Mean and Maximum Velocity Calculations Many ultrasound systems display velocity estimates on the spectral display. The notations TAMEAN...
  • Page 35 The values: 6–19 cm and 24.8–7.8 cm (within the shaded area) make up the rulers on the edges of the water dam (Figure 1-2 on page 2). Flow Profiles in the Doppler 403 Flow Phantom...

  • Page 36: Beam Width Effects

    Figure A-6. Horizontal and Diagonal Vessel Relative Lengths and Parabolic Flow Development Beam Width Effects When TAMEAN is measured on an ultrasound system, typically the Doppler range gate is set to include the entire diameter of the vessel. The intensity-weighted average velocity representing the mean Doppler shift is affected by attenuation of the beam when traveling through tissue (phantom material), and loss of low velocity readings due to wall filter settings used in the presets and/or in settings chosen by the sonographer.

  • Page 37: Beam Width Effects: Spectral Broadening

    Beam Width Effects: Spectral Broadening For flow parallel to the ultrasound beam axis, the Doppler equation is   - -    where • f = Doppler frequency shift • f = frequency transmitted by the transducer • v = velocity of scattering particles in the blood-mimicking fluid •...
  • Page 38 Figure A-9. Beam Geometry and Displayed Velocity, Vessel Depth Effect Appendix A: Flow Velocity Accuracy...

  • Page 39: Appendix B: Harmonic Imaging

    Appendix B: Harmonic Imaging Harmonic Imaging in Medical Ultrasound Harmonic imaging has become an important signal processing and display mode in medical ultrasound. In harmonic imaging an ultrasound pulse is sent from the transducer at a nominal (fundamental) frequency. If the pulse has a high enough amplitude, it undergoes a nonlinear distortion as it travels through tissues.
  • Page 40 Figure B-2. B-Mode Images of Phantom, Imaging Comparison Figure B-3 illustrates one trade-off to consider when selecting the mode for a particular examination: though a.sharper image can be realized using harmonic imaging compared with the fundamental mode, this enhanced sharpness comes with a loss of penetration. Figure B-3.

  • Page 41: Gray Scale Applications

    In order for phantoms to present valid resolution results for harmonic imaging, these three tissue properties must adequately correspond to those of human tissue. Attenuation in soft tissue increases with frequency, approximately proportional to f , where f is the frequency in MHz. This attenuation property must be present in any phantom used to study harmonic imaging performance.
  • Page 42 If the shape of the S-curve changes, the relative image brightness for each echo level also changes (Figure B-6). For example, image post-processing techniques can help to identify subtle tissue variations by modifying the shape of the curve to emphasize certain ranges of echo levels. Degradation in the system hardware can also affect the shape of the curve, producing unexpected variations in the contrast between echo levels.

  • Page 43: Appendix C: Additional Reading

    Appendix C: Additional Reading The following references may be referred to for supplemental information. Browne, J. Ramnarine, K., Watson, A., Hoskins, P. (2003). Asessment of the acoustic properties of common tissue-mimicking test phantoms. Ultrasound in Medicine and Biology, Vol. 29 (7), pp. 1053–1060. AIUM.
  • Page 44 This page is intentionally left blank. Appendix C: Additional Reading...

  • Page 45: Appendix D: Regulatory Supplement

    Symbols The following symbols are used in this guide and in Gammex, Inc. product labeling. WARNING: This symbol indicates a risk of electric shock. WARNING: This symbol indicates a hazard that could result in major injury or equipment damage.

  • Page 46: 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. Gammex's Authorized European Representative is:...

  • Page 47: Warranty

    THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRANTIES SET FORTH ABOVE. SELLER MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS OR ANY PARTS THEREOF. The product warranty can be registered at http://www.gammex.com/warranty.asp.

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