Gammex Doppler 403 Flow Phantom User manual

Title
Doppler 403TM Flow
Phantom
Model 1425B

ii
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. is prohibited.
Gammex Inc. reserves the right to make periodic modifications to this manual without obligation to
notify any person or entity of such revision.
This guide is written for Model 1425B
Doppler 403™ Flow Phantom and Multi-Frequency HE Gel™ are trademarks of Gammex Inc., a
wholly owned subsidiary of Sun Nuclear Corporation. Other trademarks or trade names are the
property of their respective owners.
Document 008315, Rev A, 05 April 2016
Gammex Inc.
7600 Discovery Drive
Middleton, WI 53562 USA
[phone]
www.gammex.com

Preface iii
Preface
Intended Use
The Doppler Flow 403 (Model 1425B) ultrasound phantom is intended to provide the user (trained
ultrasound personnel) a reference as part of a quality assurance program for clinical B-Mode, M-
Mode and Doppler Ultrasound systems.
User Needs:
1 A phantom that can:
a. Be used to perform a QC survey of Doppler ultrasound systems at installation.
b. Be used to perform annual QC surveys.
c. Test the flow velocities from constant flow rates to pulsatile flow rates.
d. Mimic the speed of sound, attenuation and echogenicity in blood and tissue.
2 A phantom that is lightweight, durable, easily portable, easy to use and reliable.
Quality and Regulatory Systems
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.
Gammex Class I medical products are listed in Europe with the Competent Authority of Germany.
Health and Safety Instructions
For instructions to report health or safety related concerns, see Reporting Health or Safety Related
Issues or Concerns on page 40.
WARNING: To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth (ground). Do not
bypass the device’s grounding system.
WARNING: Use only the Gammex-approved power supply that was
shipped with the Doppler 403 Flow Phantom. The power supply is
designed to power the system and charge the Li-ion battery.
WARNING: Do not use the phantom if the power supply or power supply
cord appear to be damaged.
WARNING: Do not immerse the phantom in liquid.
WARNING: Use only Gammex-supplied blood mimicking fluid to ensure
functionality meets specifications. Use of other blood mimicking
material will void your warranty.
WARNING: To avoid fault conditions, check for physical damage to
Doppler 403 Flow Phantom prior to and after each use.

iv Preface
• Use only distilled water or coupling gel on the scanning surface. Do not use mineral oil,
baby oil, or lanolin-based gels.
• Do not operate the phantom if visual inspection identifies physical damage. Physical
damage to the case may cause premature desiccation.
Regulatory Information
For a definition of the symbols used throughout this document and additional information related to
user and device safety, see Appendix D: Regulatory Supplement on page 39. Review this
information thoroughly before setting up and using the equipment.
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.
Italicized typeface indicates the title of a manual, a cross-referenced subsection in this manual, or
introduces a new term or phrase.
WARNING: Do not use in the presence of flammable anesthetics.
WARNING: Do not use in a sterile or corrosive environment.
WARNING: Freezing temperatures will damage the phantom. Store the
phantom at room temperature or within the 35° to 105° F (2° to 40° C)
storage range.
WARNING: Do not press the transducer into the scanning surface.
CAUTION: Routine preventive maintenance and safety testing are
recommended yearly.
CAUTION: Do not remove or otherwise damage the scanning surface material.
The Doppler 403 Flow Phantom must be used in accordance with the instructions in
this manual. Read all instructions and safety labels before use.

Contents v
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Quality and Regulatory Systems. . . . . . . . . . . . . . . iii
Health and Safety Instructions . . . . . . . . . . . . . . . . iii
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . iv
Finding Additional Information . . . . . . . . . . . . . . . . iv
Document Conventions. . . . . . . . . . . . . . . . . . . . . . iv
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Phantom Assembly. . . . . . . . . . . . . . . . . . . . . . . . . 2
HE Gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Flow System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Phantom Top Panel . . . . . . . . . . . . . . . . . . . . . . . . 3
Scanning Surface . . . . . . . . . . . . . . . . . . . . . . . . 3
Water Dam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Sono Transducer Holder. . . . . . . . . . . . . . . . . . . 4
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Mode Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Setting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Scanning Using an Abdominal Transducer. . . . . . . 5
Scanning for Color Flow Imaging . . . . . . . . . . . . . . 6
Scanning with Doppler Signals . . . . . . . . . . . . . . . . 8
Doppler QA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Doppler Signal Sensitivity and Penetration
Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Color Flow Sensitivity and Penetration Depth. . . . 10
Low Flow Sensitivity at Depth. . . . . . . . . . . . . . . . 10
Color Flow B-Mode Image Congruency . . . . . . . . 10
Directional Discrimination . . . . . . . . . . . . . . . . . . . 11
Flow Velocity Profiles . . . . . . . . . . . . . . . . . . . . . . 12
Flow Velocity Accuracy . . . . . . . . . . . . . . . . . . . 13
Sample Gate Positioning Accuracy. . . . . . . . . . 14
2D B-Mode QA . . . . . . . . . . . . . . . . . . . . . . . . . 15
B-Mode Sensitivity and Penetration Depth . . . . . . 15
Image Uniformity and Transducer Integrity. . . . . . 16
Distance Measurement Accuracy . . . . . . . . . . . . . 17
Lateral and Axial Resolution and Image
Geometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Gray Scale Display. . . . . . . . . . . . . . . . . . . . . . 20
Qualitative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Quantitative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Baseline Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Subsequent Tests . . . . . . . . . . . . . . . . . . . . . . . 21
Dual Display Analysis . . . . . . . . . . . . . . . . . . . . . . 22
Support and Maintenance . . . . . . . . . . . . . . . . 23
Caring for the Doppler 403 Flow Phantom . . . . . . 23
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Weighing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Rejuvenation and Recertification . . . . . . . . . . . . 23
Charging the Battery . . . . . . . . . . . . . . . . . . . . . 24
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Disposal and Recycling . . . . . . . . . . . . . . . . . . . 24
Contacting Gammex Technical Support . . . . . . . . 24
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . 25
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Appendix A: Flow Velocity Accuracy. . . . . . . 27
Flow Profiles in the Doppler 403 Flow
Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Mean and Maximum Velocity Calculations . . . . 28
Beam Width Effects . . . . . . . . . . . . . . . . . . . . . . . . 30
Beam Width Effects: Spectral Broadening . . . . . . 31
Appendix B: Harmonic Imaging . . . . . . . . . . . 33
Harmonic Imaging in Medical Ultrasound . . . . . . . 33
Phantom Use in Harmonic Imaging. . . . . . . . . . . . 33
Gray Scale Applications . . . . . . . . . . . . . . . . . . . . 35
Appendix C: Additional Reading . . . . . . . . . . 37
Appendix D: Regulatory Supplement. . . . . . . 39
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . 39
Reporting Health or Safety Related Issues or
Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Modifications to Equipment . . . . . . . . . . . . . . . . . . 40
Interaction with Other Electrical Equipment. . . . . . 40
EMC Precautions. . . . . . . . . . . . . . . . . . . . . . . . 40
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Contents

vi Contents
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Description 1
1 Introduction
Description
The Doppler 403™Flow Phantom, Model 1425B, is a self-contained Doppler flow and B-Mode QA
test system. The phantom provides streamlined fluid flow at variable rates in a continuous or pulsed
mode. 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.
The phantom background material is Gammex’s patented Multi-Frequency HE Gel™, a tissue-
mimicking background used to evaluate image uniformity, detect dead transducer elements, and
assess maximum penetration depth. Carefully placed targets within the gel measure axial and
lateral resolution, electronic caliper distance accuracy, and dead zone. Grey Scale targets are set
at -6 dB, and +6 dB relative to the background material, with equivalent attenuation properties.
Anechoic cylinder targets of 2, 4, and 6 mm diameters are embedded at three depths; a 10 mm
anechoic target is provided for image quality analysis. All phantom material is fully compatible with
the latest tissue harmonic imaging modes and technology, including a non-adipose tissue B/A value
and frequency-dependent attenuation.
As a flow phantom the Doppler 403 consists of a low echogenicity fluid flow system and an electronic
flow controller. Together they provide a testing source to determine maximum signal penetration,
channel isolation or directional discrimination, and flow rate readout accuracy for various angles and
beam directions. The horizontal segment of the vessel simulates a carotid artery and the diagonal
segment is used for measuring Doppler sensitivity and developing scanner techniques.
Parts
Parts included with the Doppler 403 Flow Phantom.
Figure 1-1. Doppler 403 Flow Phantom and Sono Transducer Holder Parts
Part No. Description
805660 or
805661
Doppler 403 Flow Phantom assembly, 0.5 attenuation
Doppler 403 Flow Phantom assembly, 0.7 attenuation
xxxxxx Power supply for charging Li-Ion battery (not shown)
xxxxxx Power supply pouch for power supply and cable storage and portability (not shown)
xxxxxx Test Data Sheets for recording quality assurance test results (included on memory stick or CD
008315 Doppler 403 Flow Phantom User’s Guide (this guide, not shown)
xxxxxx Sono Transducer Holder for Doppler Flow Phantom (includes cable holder)
Holds an ultrasound transducer in a precise location for repeatable quality assurance tests
007578-04 Sono Transducer Holder User’s Guide (included on memory stick or CD)
Doppler 403 Flow Phantom Sono Transducer Holder

2Section 1. Introduction
Accessories
The following Doppler 403 Flow Phantom replacement parts are available.
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. The tissue-
mimicking HE Gel, vessels, and blood-mimicking fluid are ultrasonically similar to human tissue,
which allows the use of typical clinical ultrasound system control settings when scanning the
phantom, and ensures that performance measured with the phantom approximates the scanner’s
performance in a clinical setting.
Figure 1-2. Doppler 403 Flow Phantom Features and Targets
HE Gel
The HE (High Equivalence) Gel is a patented tissue-mimicking material that makes up the phantom
background. The HE Gel has the acoustic properties of human tissue with a sound speed of
1540 +/- 10 m/s. The gel is available in 0.5 or 0.7 dB/cm/MHz attenuation values and can be used
to test transducers and systems from 2 to 18 MHz. Due to the composition of the HE Gel, the
phantom can be rejuvenated, extending use for many years.
Targets
The 18 cm deep phantom contains 0.1 mm nylon fiber targets (pin targets), anechoic cylinders of
various diameters, gray scale targets, and a continuous flow loop, all embedded in a background
material of tissue-mimicking HE Gel. The targets and features are shown in Figure 1-2.
Part Number Description
xxxxxx Scanning window cover
xxxxxx Replacement screws for scanning window cover
Target depth scale
Horizontal vessel
Diagonal vessel
Pin targets
(nylon fibers)

Phantom Top Panel 3
Flow System
A continuous flow loop vessel with one horizontal and one diagonal segment contains blood-
mimicking fluid for 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.
Figure 1-3. Doppler 403 Flow Phantom Top Panel
Scanning Surface
The patented aluminum-composite scanning surface is constructed for optimal transmission of an
ultrasound signal. The surface also protects the tissue-mimicking HE Gel from damage or
desiccation. However, the surface must be treated with care. To keep the phantom in good working
condition:
• Do not remove or otherwise damage the scanning surface.
• Do not use sharp objects on or near the scanning surface.
• Use only gentle pressure when scanning the phantom. Excessive pressure on the
scanning surface can permanently distort the surface and the near field objects (strings) in
the gel.
• Use scanning gel or fill the water dam with distilled water to optimize transducer coupling.
• Clean all scanning gel from the phantom’s surface using distilled water and a soft fabric or
paper towel following the instructions in Cleaning on page 23.
In the event the scanning surface becomes damaged or detached from the background gel, contact
Gammex for service. See Repairs on page 24.
Water Dam
The scanning surface is surrounded by the water dam. Five holes on the water dam are for mounting
the scanning window protective cover and transducer holder.
Rulers along the water dam edges (Figure 1-3) refer to transducer placement and entrance length
(in cm) needed to achieve parabolic flow relative to the horizontal and diagonal vessel tubing. Refer
to Table 3-1 on page 13. When the Doppler beam is vertically oriented in the phantom and the
sample volume is positioned within the vessel, the rulers indicate the distance the Doppler sample
volume will be from the vessel's entrance.
The numeric values on the rulers indicate distance from the origin of the vessels, which are outside
the region of the phantom accessible to ultrasound imaging.
Control panel
Diagonal
vessel ruler
(cm)
Water dam
Scanning
surface
Horizontal
vessel ruler
(cm)

4Section 1. Introduction
• The front ruler applies to the horizontal vessel; the scale increases from right-to-left,
reflecting the right-to-left flow in the horizontal vessel.
• The back ruler applies to the diagonal vessel; the scale increases from left-to-right,
reflecting the left to-right flow direction in the diagonal vessel.
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
complete instructions.
Control Panel
Mode Controls
Power Supply
The phantom is supplied with a medically rated power supply designed to charge the phantom’s
internal Li-Ion battery.
No. Item Description
1Flow Rate Display LEDs display selected flow rate in ml/s (0.0 to 12.5 ml/s)
2Fast and Slow
buttons
Adjust flow rate and select mode:
• Press to change flow rate when operating in CONTINUOUS mode
• Press to change pulse rate when operating in PULSE mode
• Press simultaneously to toggle between CONTINUOUS mode and PULSE mode
3Flow Status light On when flow controller pump is on
• On steady: Operating in CONTINUOUS mode
• Blinking: Operating in PULSE mode
4On/Off switch Activates pump in CONTINUOUS mode, and provides power to flow controller pump
Figure 1-4. Doppler 403 Flow Phantom Controls and Indicators
1234
Table 1-1. Continuous and Pulse Mode Controls
Item CONTINUOUS Mode PULSE Mode
Mode
selection
• Turn ON to activate
CONTINUOUS mode.
• Press Fast and Slow buttons
together to switch to PULSE
mode.
Press Fast and Slow buttons together to activate/deactivate
mode.
PULSE mode rate is 1 RPM when the mode starts for the first
time.
When the rate is changed and the mode is switched to
CONTINUOUS and back to PULSE, the rate returns to the
same PULSE rate that was last selected.
Fast and
Slow buttons
Increase and decrease flow rate:
• Press briefly and release to
change flow rate in single
increments.
• Press and hold to change flow
rate in multiple increments.
Increase and decrease pulse rate:
• Press briefly and release to change pulse rate
incrementally.
Pump Cycle/
Pulse Rate
On continuously. On 0.5 seconds, off 0.5 seconds, repeating, when initially
activated.
Flow rate 0 to 12.5 ml/s, in discrete steps. 0 to 12.5 ml/s; peak flow rate determined by CONTINUOUS
mode flow rate when PULSE mode is activated.
Mode
Interaction
PULSE mode flow rate/pulse determined by CONTINUOUS
mode flow rate when PULSE mode is activated.

Setting Up 5
2 Operation
Setting Up
Before starting a QA scanning session:
1Place the Doppler 403 Flow Phantom on a stable, level surface and turn power on.
2Remove the scanning surface cover.
3Select the appropriate imaging transducer for the test to be performed.
4Use a generous amount of scanning gel or distilled water to ensure sufficient coupling and good
transmission.
To prevent insufficient coupling and poor transmission, do not use mineral oil, baby oil, or a
lanolin-based gel as a coupling medium.
5Optionally install the Sono Transducer Holder on the phantom’s water dam.
Align holder pins over water dam holes and insert pins until fully seated. Be sure holder bottom
is flush against water dam on all four sides.
a. Position jaws for optimal transducer location for the QA test being performed, and secure
transducer in place using knurled knobs.
b. Record transducer position on the test data sheet.
See the Sono Transducer Holder User’s Guide for complete instructions.
Scanning Using an Abdominal Transducer
1Place abdominal transducer on scanning surface and adjust scanner's depth setting and gain
controls to display full depth of phantom.
2Orient transducer so that image plane is identical to the image planes depicted in Figure 2-1 on
page 6.
3Compare the features in the images in Figure 2-1 with their location and relative arrangement
on the phantom diagram in Figure 1-2 on page 2. Note that:
• The vessels appear hypoechoic because the fluid has a low backscatter level, mimicking
human blood.
• The 6 mm, 4 mm and 2 mm anechoic cylinders present imaging challenges for an abdominal
transducer.
• The gray scale targets at 6 cm depth stand out, as do the nylon fiber targets.
CAUTION: As with any electronic device, large temperature variations can
cause moisture and condensation which can result in errant readings. Before
operating the Doppler 403 Flow Phantom, allow 4 hours for the unit to reach
room temperature (20 – 25 °C) before powering on.
WARNING: Do not press the transducer into the scanning surface. Oil
can damage the transducer.

6Section 2. Operation
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.
When setting up for color flow imaging:
• A 5 MHz or higher frequency transducer is best for scanning the horizontal vessel. For
optimal images, use a higher frequency to view the horizontal vessel.
• A lower frequency transducer provides optimal viewing of deeper structures in the
phantom.
• Position the transducer such that the phantom targets are viewed in the same left-to-right
image plane orientation as shown in Figure 1-2 on page 2.
• When viewing color flow images, keep in mind that fluid is pumped through the vessel in a
continuous loop.
Perform the scan:
1On the phantom, select a mid-range flow rate (5–7 ml/s) using the Fast and Slow buttons.
Wait a few seconds for flow to reach the selected rate.
2On the ultrasound system, activate Color Velocity Imaging Mode.
3Select a color scheme that distinguishes flow towards the transducer (“positive flow”) from flow
away from the transducer (“negative flow”). The commonly used BART display scheme (Blue
Away, Red Towards) is shown in Figure 2-2.
Figure 2-2. Transducer Placement for Viewing Horizontal Vessel in Color Velocity Imaging Mode
4Scan the horizontal vessel (Figure 2-3 on page 7).
If the transducer is a phased or convex array, place the transducer so that the central acoustic
axis of the color image is perpendicular to the vessel axis. This can be determined by
visualizing the inner and outer surface of the vessel wall, top and bottom.
5Observe the following in Figure 2-3:
• Color display verifies right-to-left flow direction for the horizontal vessel when scanned in the
orientation depicted in Figure 1-2 on page 2.
Image plane projecting through horizontal Image plane projecting through diagonal
Flow toward the transducer
color scheme (red)
Flow away from the transducer
color scheme (blue)
Transducer

Scanning for Color Flow Imaging 7
• 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.
Figure 2-3. Color Velocity Image of the Horizontal Vessel Obtained Using a Sector Transducer
6Scan the diagonal vessel in the same scanning plane orientation used in step 4.
Figure 2-4. Color Velocity Image of the Diagonal Vessel Obtained Using a Sector Transducer
Observe the following in Figure 2-4:
• Flow is moving towards the transducer and the scanning surface for this diagonal vessel
segment.
• Orange-red color shift indicates flow towards the scanning surface.
• No flow is detected where the beam is perpendicular to the vessel, as seen in the area of no
color on the far right end of the color box (top right in the image).

8Section 2. Operation
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:
1Using the same scanning plane orientation used in Scanning for Color Flow Imaging on page 6,
place transducer on phantom.
2On ultrasound system, select B-mode display and visualize the horizontal vessel.
3Activate ultrasound system’s PW Doppler (Pulsed-Wave Doppler) mode.
4Generate a spectral Doppler signal with beam steered towards the right, as shown in Figure 2-
5, left image.
5Without moving transducer, steer Doppler beam towards the left and generate another spectral
Doppler signal, as shown in Figure 2-6.
Figure 2-5. Doppler Spectral Display of Horizontal Vessel, Beam Steering, Continuous Flow
Observe the following in Figure 2-5:
• Flow direction as established in Figure 2-2 on page 6 is verified, and flow is continuous.
• Vessel contents appear black in the gray scale images, verifying the low echogenicity of the
blood-mimicking fluid.
6Increase sample volume so
gated region includes entire
diameter of vessel.
Observe the following in
Figure 2-6:
• Flow direction is away
from the transducer.
• Compared with Figure 2-
5, a wider range of flow
velocities is displayed,
from maximum along the
vessel axis to near zero at
the vessel walls.
• A parabolic flow profile is
seen in this part of the
vessel, using a mid-range
flow rate.
Flow towards transducer Flow away from transducer
Figure 2-6. Doppler Spectral Display of Horizontal Vessel,
Continuous Flow, Full Gated Region

Doppler Signal Sensitivity and Penetration Depth 9
3 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.
QA test results are recorded on the Doppler QC Test Data Sheet, located on the CD or memory
stick. Follow the procedures in Setting Up on page 5 before beginning the QC scanning session.
Refer to Appendix A: Flow Velocity Accuracy on page 27 for information about flow velocity theory
and calculations, and to Scanning with Doppler Signals on page 8 for a Doppler scanning overview.
Doppler Signal Sensitivity and Penetration Depth
This test determines the maximum depth at which a usable Doppler signal is detected.
• The Doppler spectral display is used to indicate Doppler signal sensitivity.
• For additional instructions for performing Doppler signal procedures, refer to Scanning with
Doppler Signals on page 8.
Perform the test:
1Set the phantom to CONTINUOUS or PULSE mode with a mid-range flow rate (5–7 ml/s).
2Record the mode and rate.
3Scan the diagonal vessel.
• Starting at the vessel’s shallow end on the right side of the scanning surface (Figure 3-1, left
image), move the transducer down the vessel (right to left on the scanning surface) until the
flow waveform fades into noise at the deepest visible point of the vessel (Figure 3-1, right
image).
• The depth just before the signal fades out is the system’s Doppler Signal Penetration Depth.
Scanning Dia gonal Vess el
Figure 3-1. Scanning the Diagonal Vessel for Doppler Penetration Depth (Signal Strength)
4Record the test result on the Doppler QC Test Data Sheet.
5If required, repeat steps 1- 4at a range of flow rates from low to high.
Shallow End of Diagonal Vessel Deep End of Diagonal Vessel
Showing Signal Penetration Depth

10 Section 3. Doppler QA
Color Flow Sensitivity and Penetration Depth
This test determines the maximum depth at which usable color flow information is received.
Perform the test:
1Set 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.
2Record the mode and rate.
3On the ultrasound system, activate Color Velocity Imaging Mode (“color flow”).
4Scan the diagonal vessel.
• Starting at the vessel’s shallow end on the right side of the scanning surface, move the
transducer down the vessel (right to left on the scanning surface) until the color flow
information fades out at the deepest visible point of the vessel (Figure 3-2).
• The depth just before the signal fades out is the system’s Color Flow Penetration Depth.
Figure 3-2. Scanning the Diagonal Vessel for Color Flow Penetration Depth
5Record the test result on the Doppler QC Test Data Sheet.
6If required, repeat steps 1- 5at a range of flow rates from low to high.
Low Flow Sensitivity at Depth
This test determines the lowest flow rate that can be detected at a given depth.
1Set the phantom to CONTINUOUS or PULSE mode with a mid-to-high range flow rate (5–12.5
ml/s).
Wait a few seconds for flow to reach the selected rate.
2Record the mode and rate.
3Scan the diagonal vessel.
4On the phantom, decrease the flow rate until the Doppler signal fades out.
The lowest flow rate at which a usable Doppler signal is obtained is the Low Flow Sensitivity at
Depth.
5Record the test result on the Doppler QC Test Data sheet.
6If required, repeat steps 1- 4at a range of flow rates from low to high.
Color Flow B-Mode Image Congruency
This test verifies that the B-mode image vessel matches the location of the Doppler signal. The flow
should fill the vessel to the walls without overlapping the walls (Figure 3-3 on page 11).

Directional Discrimination 11
1Set the phantom to CONTINUOUS mode with a low (1–2 ml/s) flow rate.
2Record the mode and rate.
3On the ultrasound system, set the color flow output power and color gain for maximum
sensitivity without excessive noise.
4Scan the diagonal vessel.
5Toggle between color flow and B-mode.
a. Observe whether the color flow information is displayed only within the vessel.
b. Record scanner settings that produce poor correlation.
c. Note whether the highest flow rate occurs at the vessel’s center and the lowest flow rate at
the vessel wall.
Figure 3-3. Scanning the Diagonal Vessel for Color Flow and B-Mode Image Correlation
6Record the results on the Doppler QC Test Data sheet.
7If required, repeat steps 1- 6at a range of flow rates from low to high.
Directional Discrimination
The Directional Discrimination test evaluates the scanner’s ability to accurately display flow
direction.
With the beam perpendicular to the flow, Doppler signals and the spectral broadening artifact should
be equally positive and negative, and the magnitude of the signals should be the same.
Perform the test:
1Set the phantom to CONTINUOUS mode and set the flow rate to produce a laminar flow, at a
flow rate low enough that aliasing does not occur.
2Record the mode and rate.
3Scan the horizontal vessel.
Place the transducer so that the beam is perpendicular to the vessel axis (Figure 3-4 on page
12).
The spectral display should be equally positive and negative, mirroring across the baseline.

12 Section 3. Doppler QA
Figure 3-4. Scanning Horizontal Vessel for Directional Discrimination, Beam Perpendicular to Flow
4Angle the beam to display flow in one direction only, and verify there is no evidence of flow in
the other direction (Figure 3-5, left image).
5Angle the beam to display flow in the direction opposite from the direction in step 4, and verify
there is no evidence of flow in the other direction (Figure 3-5, right image).
Figure 3-5. Scanning the Horizontal Vessel for Directional Discrimination: Unidirectional Flow
6Record the results on the Doppler QC Test Data Sheet.
Flow Velocity Profiles
There is a velocity gradient in fluid moving inside a tube, from near zero at the wall to higher values
inside the tube. (Refer to Appendix A: Flow Velocity Accuracy on page 27.) If the velocity profile
inside the tube is parabolic, then the peak velocity along the axis of the tube is twice the average
velocity.
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.
Note that both the horizontal vessel and diagonal vessel extend outside the phantom’s scanning
area; this is reflected on the water dam ruler scales. For the horizontal vessel the ruler scale starts
at 6 cm, meaning that the corresponding point on the horizontal vessel is 6 cm from the beginning
of the vessel. For the diagonal vessel, the ruler scale starts at 7.8 cm.

Flow Velocity Profiles 13
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. This location can be
found by referring to the rulers on the water dam.
At locations short of the entrance length required for parabolic flow, the maximum velocity along the
vessel axis has a value that depends on the Doppler measurement point. As illustrated in Figure 3-6:
• For a volume flow rate of 6.0 ml/s and vessel inside diameter of 0.5 cm, 10.54 cm is needed
to achieve parabolic flow.
• For this flow rate, with the Doppler sample volume defined by transducer position 3, the
ratio vmax /vmean is 61.1/30.6 = 2. However, the ratio is less than 2 at points closer to the
entrance (right side of scanning surface).
Figure 3-6. Example, Flow Velocity and Parabolic Profiles
In the horizontal vessel, parabolic flow is achieved at volume flow rates up to 11 ml/s for sample
volumes positioned on the far left side of the scanning surface. In the diagonal vessel, parabolic flow
is achieved at all flow rates. The diagonal vessel is approximately 30% longer than the horizontal
vessel.
Refer to Appendix A: Flow Velocity Accuracy on page 27 for additional information about flow
velocity theory and the calculations used in estimating flow velocity in the phantom.
Flow Velocity Accuracy
The Flow Velocity Accuracy test evaluates the congruence between the flow velocity displayed on
the ultrasound system and the flow velocity displayed on the phantom.
1Set the phantom to CONTINUOUS mode with a low (1–2 ml/s) flow rate.
2Record the mode and rate.
3On the ultrasound system, activate PW Doppler mode.
Table 3-1. Flow Rate Estimated Velocities for Horizontal Vessel
Flow Rate (Q) Velocity (cm/s) Entry Length (cm) Reynolds
Number
Phantom
Display (ml/s)
System Display
(ml/min)
Average
(vmean)
Peak Velocity
at Parabolic
Flow (vmax)
Entry Length to
Achieve Parabolic
Flow
Re
1 60 5.1 10.2 1.76 58.57
2 120 10.2 20.4 3.51 117.14
3 180 15.3 30.6 5.27 175.71
4 240 20.4 40.7 7.03 234.28
5 300 25.5 50.9 8.79 292.85
6 360 30.6 61.1 10.54 351.41
7 420 35.7 71.3 12.30 409.98
8 480 40.7 81.5 14.06 468.55
9 540 45.8 91.7 15.81 527.12
10 600 50.9 101.9 17.57 585.69
11 660 56.0 112.0 19.33 644.26
12 720 61.1 122.2 21.08 702.83
Flow rate =
6.0 ml/s
Transducer positions
ID =
0.5 cm

14 Section 3. Doppler QA
4If 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).
5Reduce the sample volume gate to 2 mm, and position the gate so that it is centered on the
horizontal vessel axis.
6Apply angle correct so that the angle correct cursor is parallel to the direction of flow, i.e., the
vessel axis.
7Use the values in Table 3-1 to compare the displayed peak value of the ultrasound system’s
Doppler signal spectrum with the estimated peak velocity as calculated from the flow rate
displayed on the phantom control panel.
8Record the results on the Doppler QC Test Data Sheet.
9Repeat steps 1- 8at a range of flow rates from low to high.
Sample Gate Positioning Accuracy
The sample gate, or volume cursor, indicates the region in the imaged volume from which Doppler
information is collected for analysis. The Sample Gate Positioning test evaluates the accuracy of
the cursor’s location in the phantom with its representation on the B-mode image.
For this test, a small gate size produces better results.
1Set the phantom to CONTINUOUS mode with a mid-range (5–7 ml/s) flow rate.
2On the ultrasound system, set the sample volume gate size to between 1 mm and 1.5 mm.
3Record the phantom mode and rate, and ultrasound system gate size.
4Scan the diagonal vessel so that the image displayed is a cross-section of the vessel (Figure
3-7).
5Place the cursor at several locations across the vessel and measure the flow rate.
• The highest velocity reading should occur when the cursor is centered along the vessel axis.
• If the highest apparent velocity occurs when the cursor is off-center, on the edge, or outside
the vessel, service is recommended.
Figure 3-7. Scanning the Diagonal Vessel for Sample Gate Positioning Accuracy
6Record the results on the Doppler QC Test Data Sheet.