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 User’s Guide, Mini-Doppler Flow Phantom

© 2019 by Gammex Inc. All rights reserved.

The information contained in this guide is copyrighted and all rights are reserved by Gammex Inc.
Copying, duplicating, selling, or otherwise distributing any part of this manual without the prior 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 1430 LE,
Other trademarks or trade names are the property of their respective owners.
Document 007809-00-08

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

ii
 Preface
Intended Use

Intended to provide for routine and periodic verification of high resolution ultrasound patient
diagnostic imaging performance for the identification of disease and pathologies.

Limitations of Use

The 1430 LE is designed to be operated in battery mode. Using the system with the charger plugged
in may introduce unwanted noise.

The 1430 LE phantom is designed to be used to aid in the Quality Control testing and monitoring of
ultrasound instruments only. It is not to be used for diagnostic decisions.

Quality and Regulatory Systems

Gammex meets worldwide standards including EN ISO 13485 and FDA 21 CFR 820.
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 medical device.
Gammex Class I medical devices 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 25.

WARNING: Do not remove the phantom’s surface material. The phantom

comes ready to scan.

WARNING: This phantom is designed for indoor use only.

WARNING: Store your 1430 LE with cover closed securely.

Always attach the scanning surface cover and store the phantom out of
direct sunlight when it is not in use.

WARNING: Weigh the phantom when you first receive it and then every 6
months after that. Record the values on the data sheet.

WARNING: Return the phantom for inspection and/or repair if it has been
dropped or damaged. Physical damage to the case will cause premature
desiccation.

WARNING: If your 1430 LE is not regularly in use, step the 1430 through
the constant and pulsatile flow settings for a period of 1-2 hours on a
monthly basis. This will keep the scatterers in the blood mimicking fluid
in suspension.

Preface iii
 WARNING: Freezing temperatures will damage the phantom and high
temperatures will accelerate desiccation. Store the phantom at room
temperature or within the 35° to 105° F (2° to 40° C) storage range.

CAUTION: As with any electronic device, large temperature variation can

cause moisture and condensation problems which can result in errant
readings. Therefore, before operating the 1430, allow the unit to reach room
temperature of 20-25ºC for at least four hours.

Note: Gammex recommends annual servicing of your 1430 LE to ensure proper

operation. Our qualified service technicians will check for desiccation and provide any
needed rejuvenation, as well as scanning and certification to original specifications, and
repairs

The Mini-Doppler Flow Phantom must be used in accordance with the instructions in
this manual. Read all instructions and safety labels before use.

Regulatory Information

For a definition of the symbols used throughout this document and additional information related to
user and device safety, see Appendix B: Regulatory Supplement on page 25. Review this
information thoroughly before setting up and using the equipment.

Finding Additional Information

For more information about this phantom, refer to the Gammex website —www.gammex.com. Visit
the website for the latest product information and product updates.

iv Preface
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Directional Discrimination . . . . . . . . . . . . . . . . . . . 13
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Accuracy of Flow Velocity Readout . . . . . . . . . . . . 13
Limitations of Use . . . . . . . . . . . . . . . . . . . . . . . . . . iii Accuracy of Sample Gate Positioning . . . . . . . . . . 14
Quality and Regulatory Systems. . . . . . . . . . . . . . . iii
Support and Maintenance . . . . . . . . . . . . . . . . 15
Health and Safety Instructions . . . . . . . . . . . . . . . . iii
Caring for the 1430 LE Phantom . . . . . . . . . . . . . . 15
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . iv
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Finding Additional Information . . . . . . . . . . . . . . . . iv
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Monitoring the Phantom’s Weight . . . . . . . . . . . 15
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Rejuvenation and Recertification . . . . . . . . . . . . 15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
........................................ 2 Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Evaluating the Phantom . . . . . . . . . . . . . . . . . . . 2 Disposal and Recycling . . . . . . . . . . . . . . . . . . . 16
Quantitative Measurement . . . . . . . . . . . . . . . . 7 Contacting Gammex Technical Support . . . . . . . . 16
Quantitative Procedure . . . . . . . . . . . . . . . . . . . . . . 7 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . 17
Baseline Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Phantom Specifications . . . . . . . . . . . . . . . . . . . . . 17
Subsequent Tests . . . . . . . . . . . . . . . . . . . . . . . . 7 Target Specifications . . . . . . . . . . . . . . . . . . . . . . . 17
Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Doppler Mode Phantom Specifications . . . . . . . . . 17
Qualitative Measurement . . . . . . . . . . . . . . . . . 8 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Qualitative Measurement Procedure . . . . . . . . . . . 8
Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Appendix A: Harmonic Imaging . . . . . . . . . . . 21
Harmonic Imaging . . . . . . . . . . . . . . . . . . . . . . . . . 21
Doppler Overview . . . . . . . . . . . . . . . . . . . . . . . 9 Grey Scale Applications . . . . . . . . . . . . . . . . . . . . 21
Doppler Guided Tour . . . . . . . . . . . . . . . . . . . . . . . 9 System Linearity . . . . . . . . . . . . . . . . . . . . . . . . 22
Pulse Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Evaluating the Doppler System. . . . . . . . . . . . . 10 Appendix B: Regulatory Supplement. . . . . . . 25
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Doppler Quality Control Tests . . . . . . . . . . . . 12 Operator Responsibility . . . . . . . . . . . . . . . . . . . . . 25
Doppler Signal Sensitivity . . . . . . . . . . . . . . . . . . . 12 Reporting Health or Safety Related Issues or
Color Flow Sensitivity . . . . . . . . . . . . . . . . . . . . . . 12 Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Flow Sensitivity at Depth. . . . . . . . . . . . . . . . . . . . 12 Modifications to Equipment . . . . . . . . . . . . . . . . . . 26
Color Flow B-Mode Image Congruency . . . . . . . . 12

Contents v
vi Contents
 1 Introduction
Description

The Gammex 1430 LE Mini-Doppler Flow Phantom is an instrument for measuring the image quality of small
parts and intra-cavity ultrasound scanning systems. The tissue mimicking gel is ultrasonically similar to human
tissue. This allows the use of normal scanner control settings and ensures that the performance measured with
the phantom closely approximates the scanner’s performance in a clinical examination.
Scanning is the best way to familiarize yourself with the features and functions of the 1430 LE. A guided tour of
the phantom is provided on the following pages.

Description 1
 2 Operation
WARNING: The phantom comes ready to scan. Do not remove the
surface material.

• Always place the phantom on a stable, level surface for scanning.

• Use distilled water or a generous amount of coupling gel to ensure good transmission.
• Do not use mineral oil, baby oil, or lanolin-based gels as a coupling medium. Poor
transmission is a result of insufficient coupling.
• Clean the scanning surface immediately after use. Use a soft cloth or paper towel and soap
and water, if needed.

WARNING: Do not press the transducer into the scanning surface. This
behavior damages the scanning surface and shortens the life of the
phantom. For curved transducers, use water or a thick gel layer.

Evaluating the Phantom

A 4.5 MHz probe provides a good overall view of the phantom for this demonstration.
1 To couple with water, fill the dam with distilled water. For a better image quality, use gel.
2 Rest the transducer on the scanning surface. Adjust the scanner to display the full depth of the
phantom.

You might notice that the tissue echoes near the bottom of the phantom fade into noise. The
depth at which usable echoes disappear is the depth of penetration. The depth markers on the
phantom label will help you determine the depths of the targets.
3 Move the transducer across the scanning surface while observing the locations of the targets.

Notice how the smooth texture of the tissue mimicking gel emphasizes image non-uniformities
and artifacts, making them easier to detect. Scanning an area without targets is a good way to
test for image uniformity.

Decrease gain controls to highlight pin targets.

4 Scan the vertical pin targets and freeze the image. Use the electronic calipers to measure the
distance between two of the vertical pin targets. Repeat for two of the horizontal pin targets.
The vertical pins have 5 mm spacing while the horizontal pins have 10 mm-spacing.

Use the pin targets to determine vertical distance accuracy and horizontal distance accuracy.
The highest dead zone pin you can see should be the point of reference not the scanning
surface.

2 Section 2. Operation
 0.1 mm nylon
pin
Use the
calipers to
measure
vertical
distance
accuracy

and horizontal
distance accuracy

5 Freeze an image of the resolution target group at 1 cm. Examine the horizontal row of pins at
the top of the target group. The pins that are closest together without touching indicates the
scanner’s lateral resolution.

6 Repeat this procedure with the other resolution target groups. Notice how lateral resolution is
narrowest in the focal zone. For a transducer whose focal zone is in the area between the
resolution targets, an alternate test can be performed. Freeze an image of the vertical pin
targets. Use the electronic calipers to measure the horizontal width of the pin targets in the
near, mid and far fields of the image.

3
 Notice how the pin targets are narrowest in the focal zone. The pin width demonstrates the
width of the ultrasound beam at that depth and approximates the lateral resolution of the
scanner.

4 Section 2. Operation
7 Decrease the image depth and examine the resolution target group at 1 cm. Notice how the
images of the lower pin targets may begin to merge. The smallest distance between two pins
that can be clearly resolved with no vertical overlap is called the scanner’s axial resolution.

Unresolved Resolved

Pin targets are resolved axially if an imaginary horizontal line can be drawn between the targets
without touching either target. The targets on the left are not resolved. The targets on the right
are resolved.

Examine the other resolution target groups and compare the resolution at various depths. Axial
resolution might change with depth. Scan the nearest cystic target group.
8 Scan the nearest cystic target group. Each target should be round with a clean black
appearance and well defined edges. Bright specular echoes at the top and bottom of the targets
are normal.

Normal Distorted System noise

Measure the dimensions of the 4 mm cystic target to check the image geometry. Use the
calipers to measure from top to bottom and side to side. Repeat with the other cystic target
groups as part of the cyst imaging test.

9 Decrease image depth to the minimum and examine the dead zone target group. You can also
use the dead zone targets to measure lateral resolution in the extreme near field of the
transducer.
• The highest dead zone pin you can see should be the point of reference for all
measurements – not the scanning surface.
10 Scan the four grey scale targets and observe the difference in their grey levels. Adjust the gain
control and observe how this affects the brightness of the targets. Notice how noise in the
anechoic target becomes apparent as the gain increases. If your system has image post-
processing capabilities, observe how the contrast between targets changes with different
settings.

5
 Adjust the gain control to the lowest noise level. This is the point at which you eliminate noise
in the anechoic cyst (lower the gain until it just disappears). Record this gain setting and use it
for future grey scale measurements. Freeze the image and visually evaluate the grey scale
targets. Match each target with a step on the grey bar in the image. Make a hard copy and
compare the hard copy with the image on the scanner.
11 When you finish scanning the phantom, empty the water dam or completely clean off the
coupling gel with a soft cloth or paper towel. Replace the cover and secure by lifting the handle
to protect the phantom.

6 Section 2. Operation
 3 Quantitative Measurement
A target’s brightness level can be most accurately measured using electronic methods. The user
defines a region of interest and the scanner determines the average pixel value. To reduce the effect
of speckle and small variations in the targets, take and average several measurements.
Note: If your system does not have a region of interest (ROI) tool, you can’t perform this test. As an
alternative, refer to the Qualitative Measurement on page 8 of this document.
Note: All values determined by the quantitative measurement test depend on scanning technique.
Take great care to perform the test in the same manner each time.

Quantitative Procedure

Baseline Test
1 Scan the grey scale targets and display them as large as possible. Freeze the image.
2 Measure the echo level of the anechoic target. Adjust the system gain so that the measurement
is approximately 1. This ensures that the system’s noise floor is barely reaching the visible
level.
3 Record this setting and reuse for all subsequent tests.

Subsequent Tests
1 Scan the grey scale targets and display them as large as possible. Adjust the system control
settings as recorded on the data sheet.
2 Freeze the image and place the region of interest (ROI) tool completely inside the grey scale
target image. The ROI should be approximately 2/3 – 3/4 the diameter of the circle, and it
should be centered in the circle.
3 Measure and record the echo level of each target.
4 Measure and record the echo level of the background material directly beside the anechoic
target. Use as close to the same ROI as the target as possible. Unfreeze the image.
5 Perform this process three times and record the average echo level.

Analysis

Contact your service engineer if target 2, 3, or 4 varies from the baseline by 10% or more.

Quantitative Procedure 7
 4 Qualitative Measurement
Video monitors on most ultrasound systems contain a grey bar that shows the grey levels available
for display. Grey bars normally contain between sixteen and sixty-four steps of increasing
brightness. You can estimate pixel values by locating a grey bar step that approximates the
brightness of the region of interest.
Note: It is absolutely critical that all system control settings be precisely reproduced for these tests.
Errors introduce variations in your data and might invalidate your results.

Qualitative Measurement Procedure

1 Assign a unique number to each grey level on the grey bar.

2 Scan the grey scale targets and display them as large as possible. Freeze the image.
3 For each target, determine which step on the grey bar is the same brightness as the target and
record this number on the data sheet. Do the same for the background material directly beside
the anechoic target. Keep a print out of the image for reference.

Analysis

Contact your service engineer if any target varies from the baseline by more than two steps.

8 Section 4. Qualitative Measurement

 5 Doppler Overview
Flow instruments and string test objects are two types of Quality Control test tools for Doppler
ultrasound scanners. Flow instruments, such as the Gammex 1430 LE, produce physiological flow
rates and can be used to perform the full range of quality and acceptance tests.
“Flow phantoms provide a more realistic signal environment in which a spectrum of velocities is
produced across the flow profile of a simulated vessel. Flow instruments can be calibrated in terms
of absolute flow rates (and, therefore, maximum velocities).”4
Flow phantoms mimic blood flow in the body; the continuous stream simulates venous flow.5 The
angled vessel is used to measure sensitivity for different frequency transducers and accuracy of the
Doppler angle (refer to Gammex 1425A Optimizer). The variable flow speeds test the accuracy of
the Doppler shift. Good flow instruments are self-contained and provide an accurate speed of
sound. They are also practical for routine quality control and comparison of ultrasound systems as
well as teaching the principles of Doppler ultrasound.1
String phantoms are not physiological.7 String phantoms display a specular-like reflection from the
string surface which could produce uncertainties in specifying the exact Doppler angle.10 The knot
signal on the spectral display shows as a regular spike, this can interfere with visualization of the
Doppler spectrum.7 Also, the water tank can produce unwanted reverberations and reflections.

Doppler Guided Tour

When the unit is first turned on, the phantom enters Continuous mode and the pump spins at
approximately one-half maximum speed.
The LED is lit when the pump is running.
Momentarily pressing the Fast button increases the speed a small amount. Pressing and holding
down the Fast button increases the speed 4 times faster. The Slow button works the same way as
it relates to decreasing the speed.
The LED turns off when the pump is off.
There are 180 discrete speed steps.

Pulse Mode
Simultaneously pressing the Fast and Slow buttons enters the Pulse mode. When the phantom
enters Pulse mode, the pump pulses for 0.5 seconds on and 0.5 seconds off. The speed of the pump
is set in Continuous mode. Pressing the Fast button pulses the pump faster. Pressing the Slow
button pulses the pump slower.
The Pulse rates are:
1 0.125 seconds on, 0.125 seconds off
2 0.250 seconds on, 0.250 seconds off
3 0.375 seconds on, 0.375 seconds off
4 0.500 seconds on, 0.500 seconds off
5 0.625 seconds on, 0.625 seconds off
6 0.750 seconds on, 0.750 seconds off
7 0.875 seconds on, 0.875 seconds off
8 1.000 seconds on, 1.000 seconds off
To return to Continuous mode, press the Fast and Slow buttons at the same time.

Doppler Guided Tour 9

 Evaluating the Doppler System
For the Doppler demonstration:
• Use a 5 MHz transducer
• Turn on the Doppler Mode
1 Select a flow rate preset using the Up/Down buttons. It takes a few seconds for the flow to reach
the selected rate.
2 Use a sector transducer to scan the blood vessel. Place the transducer so that the central
acoustic axis of the color image is perpendicular to the axis of the vessel. This can be
determined by visualizing the inner and outer surface of the vessel wall, both on the top and
bottom.

10 Section 5. Doppler Overview

 3 Examine the image. The positive color flow segment should mirror the negative color flow
segment across the image of the vessel. Proper color balance demonstrates the scanner’s
directional discrimination.

4 Scan the blood vessel so that the image displayed is a cross-section of the vessel. With the flow
phantom in constant flow mode, place the cursor at several locations across the vessel and
measure the velocity. The highest velocity reading should occur when the cursor is placed in
the center of the vessel. This test evaluates the accuracy of the sample gate positioning.

5 Scan the vessel along its length with the flow phantom in continuous flow mode. Close the
sample gate to the smallest opening. Compare the displayed peak value on the scanner with
the estimated peak value, corresponding to the displayed flow on the control module, to
determine the accuracy of the maximum velocity readout. Use the provided chart to translate
Flow measurements into estimated speed.
6 Use color tagging techniques to verify the maximum velocity readout. By using tagging
techniques, isolate each flow rate and identify the maximum flow rate. This value should be
near the value in step 5.
7 When you have finished scanning the phantom, completely clean off the coupling gel or water
with a soft cloth or paper towel. Turn off the Doppler Mode and close the cover to protect the
phantom.

Doppler Guided Tour 11

 6 Doppler Quality Control Tests
Doppler Signal Sensitivity

This test determines the depth at which usable Doppler signal is detected. Measuring
the maximum range at which the Doppler signal is detected with the audible Doppler
signal and the Doppler spectral display indicates the Doppler Signal Sensitivity.
1. Set the 1430 Phantom to produce a pulsatile or constant flow in the mid-range of flow rates.
Scan the angled vessel. Start with the shallow end and move down the vessel until the flow
waveform disappears into noise.
The depth just before the signal fades out is the system’s Doppler Signal Sensitivity.
Repeat this test at a range of flow rates from low to high.
Record the results on your Doppler QC Test Data Sheet.

Color Flow Sensitivity

Similar to the Maximum Depth of Penetration test, this test determines from what depth
into the test instrument color flow information can be received.
1 Set the 1430 Phantom to produce a pulsate or constant flow in the mid-range of flow rates.
Record the rates.
2 Scan the angled vessel. Start with the shallow end and move down the vessel until the color
flow information disappears.
3 The depth just before the signal fades out is the system’s color flow sensitivity.
4 Repeat this test at a range of flow rates from low to high.
5 Record the results on your Doppler QC Test Data Sheet.

Flow Sensitivity at Depth

This test determines the lowest flow rate that can be detected at a given depth.
1 Set the 1430 Doppler Phantom to produce a pulsate or constant flow in the mid to high-range
of flow rates.
2 Scan the angled vessel at a depth of 5 cm.
3 Decrease the flow rate until the Doppler display disappears. The lowest flow rate at which a
useful Doppler signal is obtained is the flow sensitivity.
4 Repeat this test at various depths in the phantom.
5 Record the results on your Doppler QC Test Data Sheet.

Color Flow B-Mode Image Congruency

Verify that the B-mode image vessel is where the Doppler signal is. The flow should fill
the vessel to the walls and should not overlap the walls.
1 Set the 1430 Doppler Phantom to constant flow mode.
2 Set the scanner’s color flow output power and color gain for maximum sensitivity without
excessive noise.
3 Toggle between color flow and B-mode. Observe whether the color flow information is
displayed only in the vessels. Record scanner settings that produce poor congruency. Also

12 Section 6. Doppler Quality Control Tests

 note whether the highest flow occurs at the vessel’s center and the lowest flow at the vessel
wall.
4 Record the results on your Doppler QC Test Data Sheet.

Directional Discrimination

Flow moves either toward or away from the transducer. The Directional Discrimination test
evaluates the scanner’s ability to accurately display flow direction. With the flow perpendicular to the
Doppler beam, Doppler signals resulting from spectral broadening are usually obtained. If the beam
is perpendicular to flow, the spectral broadening artifact should be equally positive and negative and
the magnitude of the signals should be the same.
1 Set the 1430 Phantom in constant flow mode and produce a laminar flow with a velocity low
enough that aliasing does not occur.
2 Scan the horizontal vessel with a sector transducer. Place the transducer so that the central
acoustic axis of the color image is perpendicular to the axis of the vessel. To do this, adjust the
transducer until the top wall and bottom wall of the vessel are both clear on the image.
3 The positive color flow segment should mirror the negative color flow segment across the image
of the vessel.
4 The spectral display should be equally positive and negative, mirroring across the baseline.
5 Angle the Doppler beam to display flow in one direction only. There should be no evidence of
flow in the other channel.
6 Record the results on your Doppler QC Test Data Sheet.

Accuracy of Flow Velocity Readout

An accurate estimate of the velocity within a flow pipe, given the volume flow rate, depends on the
velocity profile within the tube. If the profile is assumed parabolic, the maximum velocity inside the
tube is 2x the average velocity. If the flow is turbulent or has some characteristic other than laminar,
then the velocity calculation becomes much more challenging.
Generally, as flow enters a tube, the velocity profile will not be parabolic, but will gradually become
so, depending on flow conditions, rate, and tube diameter. The distance it takes depends on the
nature of the flow profile entering the tube.
The Reynolds number (Re) is used to distinguish between different flow classifications, namely
laminar and turbulent flow. Laminar flow occurs at low Reynolds numbers, where viscous forces are
dominant, and is characterized by smooth, constant fluid motion. Within circular pipes, the critical
Reynolds number is generally accepted to be 21009. In order to assume well-known flow conditions
at a measuring point, the inner area of the tube shall be uniform over an entrance length L that is
for a laminar flow.

Where Di is the inner diameter of the tube.

The Reynolds number is:

Where μ is the dynamic viscosity of the fluid, ρ is the density, and l is the characteristic length, which
is conventionally considered the inner diameter. The velocity averaged over a cross-section of the
tube is:

Where Q is the flow rate and Ri is the radius of the inside of the tube.

Directional Discrimination 13
 The flow rate, Q, is described as:

Where Δp is the drop in pressure along the tube over length l.

In case of a parabolic velocity profile, the axial velocity is:

We cannot assume that the flow of the fluid as it enters the 1430 system is laminar. Therefore, the
entrance length can only be estimated to be some value between the value found by the above
equation, and the value from the equation of the entrance length for turbulent flow, which is
described as:

1 Set the Doppler phantom to produce a constant flow at a low flow rate.
2 Close the gate to the smallest size available and center it in the vessel. This will sample the flow
rate at its highest velocity.
3 Compare the measured peak velocity value to the estimated velocity value on the 1430 LE
Flow/Speed conversion chart.
4 Record the results on your Doppler QC Test Data Sheet.

Accuracy of Sample Gate Positioning

The sample gate or volume cursor indicates the region in space from which Doppler information is
collected for analysis. The location of the cursor in the phantom should be accurately represented
on the B-mode image.
Note: A small gate size is preferred.
1 Set the Doppler phantom to produce a constant flow.
2 Scan the vessel so that the image displayed is a cross-section of the vessel.
3 Place the cursor at several places across the vessel and measure the flow rate.

The highest velocity reading should occur when the cursor is placed in the center of the vessel.
If the strongest signal occurs when the cursor is off-center, on the edge, or outside the vessel,
service is recommended.
4 Record the results on your Doppler QC Test Data Sheet.

14 Section 6. Doppler Quality Control Tests

 7 Support and Maintenance
Caring for the 1430 LE Phantom

WARNING: The phantom comes ready to scan. Do not remove the

surface material.

Cleaning
Clean the scanning surface after use. Scanning gel left on the surface might degrade the phantom’s
appearance. Wipe off any gel or distilled water, and wash gently with a damp cloth. Do not immerse
the phantom in any fluid. Do not use any solvents or abrasive cleaners.

Storage
Gammex designed the patented HE Gel to last for years when properly maintained and stored. After
cleaning the phantom, follow these storage guidelines.
• Store the phantom with the cover tightly closed within an airtight container. This action
contributes greatly to long phantom life.
• Store the phantom out of direct sunlight when not in use.
• Store the phantom in an indoor, protected environment at room temperature (20–25 °C). If
room temperature cannot be maintained, the phantom must be stored within the 35–105 °F
(2–40 °C) range. Freezing temperatures damage the phantom. High temperatures might
accelerate desiccation.

Monitoring the Phantom’s Weight

The phantom’s background gel desiccates very slowly over time. The phantom should be weighed
when received, and periodically thereafter. Record the weight in the Phantom Weight Chart provided
on the CD or memory stick included with the phantom.
• Weigh the phantom before first use, and record the weight.
• For most climate-controlled environments, you should weigh the phantom every 6 months
thereafter, and record the weight. If the phantom is in use in a high temperature and low
humidity environment or in mobile situation, you should test the phantom more frequently.
Consistency in the recorded weights indicates that the gel’s moisture level and scanning
characteristics are stable.
• If your organization observes a weight difference of 2 grams or more within 6 months,
contact Gammex Support. Refer to Contacting Gammex Technical Support on page 16.

Rejuvenation and Recertification

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 prolongs the life
of the phantom for many years, and ensure that it continues to meet Gammex specifications.
Over time, the patented HE Gel slowly loses moisture. This process can be accelerated by high
temperatures, incorrect storage, and damage to the case or scanning surface. Follow the
instructions in the Storage section above to reduce the amount of moisture lost.

Important! We recommend that your organization send in the phantom for rejuvenation after it has
lost 10-15 grams of its original weight. If the phantom has lost more than 20 grams, Gammex cannot
guarantee that the phantom will be able to rejuvenate successfully.

Weighing the phantom as directed in the Monitoring the Phantom’s Weight section above provides
information about the relative moisture levels in the phantom.

Caring for the 1430 LE Phantom 15

 Note: There are no international standards for ultrasound phantoms. Gammex's rejuvenation
process can restore the phantom to within our manufactured product specifications.

Maintenance

Repairs
There are no user-repairable parts. Only qualified personnel should attempt to service the phantom.
If the phantom fails to function properly, contact Gammex. See Contacting Gammex Technical
Support.

Parts
Your organization can order accessories from the Gammex Sales department: Telephone +1 608-
828-7000.

Disposal and Recycling

When the components are no longer functional or are otherwise ready to be discarded, recycle or
dispose of them according to local waste management or recycling regulations.

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

Contacting Gammex Technical Support

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

16 Section 7. Support and Maintenance

 8 Specifications
Phantom Specifications

Table 8-1. 1430 LE Phantom Specifications*

Category Characteristic Specification

Phantom Weight Approximately 1.75 kg (3 lbs. 13 oz.)
Specifications Dimensions 17 x 8.25 x 11.4 cm (6.75 x 3.25 x 4.50 in.)
Case Material ABS plastic
Pint Target Material Nylon monofilament
Scanning Surface Composite film
Tissue Mimicking Material Water-based HE gelTM with the appearance of
Background human tissue.
Material
Speed of Sound 1540±10 m/s
Temperature dependence of speed of 1.5 m/s/ºC
sound
Attenuation Coefficient 0.7±0.05 dB/cm/MHz
0.5±0.05 dB/cm/MHz
Refer to phantom side label
All acoustic measurements made at 4.5 MHz, 22º C.
*Due to our philosophy of continuous quality improvement, all specifications are subject to change.

Target Specifications

Table 8-2. 1430 LE Phantom Target Specifications*

Category Characteristic Specification

Cystic Targets Diameters 1, 2, 4, and 7 mm
Placement 1, 3, 3.5, and 6 cm deep
Speed of Sound 1540±10 m/s
Attenuation Coefficient 0.05±0.01 dB/cm/MHz
Grey Scale Targets Diameter 7 mm
Placement 3 cm deep
Speed of Sound 1540±10 m/s
Temperature Dependence on Speed 1.5 m/s/ºC
of Sound
Contrast -6 dB, +6 dB, high scatter relative to background
Pin Targets Diameter 0.1 mm
Vertical Spacing 5 cm at 1 to 9 cm deep
Horizontal Spacing 10mm at 1 and 5 cm deep
Resolution Target Depth 1, 3.5, and 6 cm deep
Groups
All acoustic measurements made at 4.5 MHz, 22º C.
*Due to our philosophy of continuous quality improvement, all specifications are subject to change.

Doppler Mode Phantom Specifications

The 1430 LE phantom comes with a 14.8 V Li-Ion rechargeable battery made of 4 high quality
cylindrical 18650 cells, with PCB and poly-switch for full protection.

Phantom Specifications 17
 WARNING: Li-Ion battery might explode if charging or discharging
improperly. User must have the knowledge of how to charge and
discharge Li-Ion battery before using Li-Ion battery pack. We recommend
that you use our smart Li-Ion battery charger to recharge the battery
pack. Never use a conventional DC adapter to charge the battery module.

WARNING: We are not responsible for any damage that is caused by the
misuse of the Li-Ion battery.

Category Characteristic Specification

Li-Ion Battery AC Input 100-240V
Charger DC Output 14.8V, 500mA
Environmental IPXX No special protection against ingress of liquids or
Conditions dust.
Operating Temperature 0 to +40ºC
Storage Temperature 0 to +40ºC
Humidity 30-85% Relative Humidity (No dew condensation)
Tissue Mimicking Speed of Sound 1550±10 m/s
Blood Material Density 1.03 g/cm³
Average Particle Diameter 4.7 μm Particle
Particle Concentration 20 mg/ml
Total Volume approximately 100 ml
Viscosity 3.8 x 10-3 Pa s (-0.11 x 10-3 Pa s/ºC)
Vessel Speed of Sound 1550±10 m/s
Density 1.03 g/cm³
Inner Diameter 4 mm
Wall Thickness 1 mm
Positions Horizontal at 2 cm deep
Diagonal 35º from 2 cm deep (at wall)
Re 850 at max velocity
L 10.5 cm at max velocity
Flow Meter Type in-line turbine
Accuracy better than 1.5% F.S.*
*The microprocessor-based flow controller within the 1430 produces accurate flow rates from 1.0 to 10 ml/sec
with better than 1.5% Full Scale Accuracy. However, the accuracy of the 1430 system as a whole is based on
a number of factors, including (but not limited to) temperature, flow setting, ultrasound settings, etc. The
accuracy of the complete 1430 system might vary. For more information, see Accuracy of Flow Velocity
Readout on page 13.
*Due to our philosophy of continuous quality improvement, all specifications are subject to change.

18 Section 8. Specifications
 9 References
1 AIUM. (1994) Performance Criteria and Measurements for Doppler Ultrasound Devices (pp. 28
– 33) Laurel, MD: American Institute of Ultrasound in Medicine.
2 AIUM. (1995) AIUM Quality Assurance Manual for Gray-Scale Ultrasound Scanners Laurel,
MD: American Institute of Ultrasound in Medicine.
3 Boote, E.A., & Zagzebski, J.A., (1988) Performance Tests of Doppler Ultrasound Equipment
With a Tissue and Blood-Mimicking Phantom. Journal of Ultrasound in Medicine 7, 137-147.
4 Groth, D.S., Zink, F.E., Felmlee, J.P., Kofler, J.M., James, E.M., Lindsey, J.R. & Pavlicek, W.
(1994). Blood Flow Velocity measurements: A Comparison of 25 Clinical Ultrasonographic Uits.
Journal of Ultrasound in Medicine 14, 273-277.
5 Hendrick, W.R., (1995) Quality Control and Acceptance Testing. In W.R. Hendrick, S.D.L.
Hykes, & D.E. Starchman (Ed.), Ultrasound Physics and Instrumentation (3rd Edition) (pp. 280
– 313). Mosby Yearbook.
6 IEC 61685:2001, International Standard.
7 IPSM. (1994) P.R. Hoskins, S.B.Sheriff, & J.A. Evans (Ed.), Testing of Doppler Ultrasound
Equipment (Report No. 70). York, Great Britain: The Institute of Physical Sciences in Medicine.
8 IPSM. (1995) Robert Price (Ed.), Routine Quality Assurance of Ultrasound Imaging Systems
(Report No. 71). York, Great Britain: The Institute of Physical Sciences in Medicine.
9 Munson, B.R., Young, D.F., Okiishi, T.H. (2006) Fundamentals of Fluid Mechanics, Fifth
Edition. John Wiley & Sons, Inc., Hoboken, N.J.
10 Zagzebski, J.A., (1995) Acceptance Tests for Doppler and Color Flow Imaging Equipment. In
Lee Goldman & Brian Towlhes (Ed.) Medical CT and Ultrasound: Current Technology and
Applications (pp. 197-209). Madison, WI: Advanced Medical Publishing.

Doppler Mode Phantom Specifications 19

20 Section 9. References
 Appendix A: Harmonic Imaging

Harmonic Imaging

Harmonic imaging is an important scanning mode in medical ultrasound. Harmonic imaging is done
by transmitting a pulse from the transducer at a nominal frequency, the fundamental frequency, and
processing the received signals to detect echoes at twice that frequency, which is the second
harmonic. The result is that better resolution can be attained at a given depth than if the reception
had been at the fundamental frequency, as in conventional ultrasound. Reverberations and side
lobe artifacts are reduced, axial and lateral resolution is increased, and the signal to noise ratio
might be greater than that obtained when transmitting and receiving at the frequency of the
harmonics. In many cases, image quality is improved by using harmonic imaging.
There are three tissue properties that determine the effectiveness of harmonic imaging:
• Pulse propagation speed
• Attenuation (rate of pulse energy loss with depth)
• The value of the nonlinearity parameter: B/A
In order for phantoms to present valid resolution results for harmonic imaging, these three properties
must adequately correspond to human tissue.
The B/A value quantifies the rate of transfer with respect to propagation distance of ultra- sonic
fundamental frequency energy to harmonic frequencies. The greater the B/A value, the greater the
energy transfer rate. Generally, the beam profile for the harmonic is narrower than for the
fundamental, which means better lateral and elevational resolution in the harmonic signal.
Tissue-mimicking phantoms are appropriate for assessing harmonic imaging only if the B/A value
for the tissue-mimicking material in the phantom adequately approximates that of soft tissues.
Measurements of the value of B/A for the tissue-mimicking materials in Gammex phantoms indicate
results lie in the range for non-adipose soft tissue, meaning B/A is between 6 and 7.1

Grey Scale Applications

Metastases are sometimes slightly hyperechoic or hypoechoic compared with the surrounding
tissue. If the scanner is not measuring grey levels accurately, the metastases may not be detected.
The Quantitative Measurement ensures that the grey level signal is measured consistently. The
Qualitative Measurement ensures that grey levels are displayed on the monitor consistently. By
performing these tests, the user can determine the optimal system settings for measuring grey
levels, which can then be used in clinical applications.

1. Gong, X. F., Zhu, Z. M., Shi, T., Huang, J. H. (1989) Determination of the acoustic nonlinearity parameter in
biological media using FAIS and ITD methods, J. Acoust. Soc. Am. 86 (1), pp 1-5.

Harmonic Imaging 21
 System Linearity
Ultrasound systems use special processing circuits to translate the amplitude of echoes into
brightness levels on the display monitor. These circuits use mathematical functions that often
produce an S-shaped curve when the mean pixel value data are plotted vs the target echo level. As
shown in the figure below, for a given set of operating conditions, each echo level produces a
corresponding brightness level on the monitor.

Figure B-1. An S-shaped curve is used to translate echo levels into brightness levels on the video
display. Notice how different echo levels, –X, 0 and +X dB produce corresponding brightness
values B–, Bo and B+.

For example, image post-processing techniques help the user identify subtle tissue variations by
modifying the shape of the S-curve to emphasize certain ranges of echo levels. Degradation in the
system hardware can also affect the shape of the curve and produce unexpected variations in the
contrast between echo levels. The distortion in the information displayed to the user might affect the
interpretation of the ultrasound image.

22 Appendix A:. Harmonic Imaging

 Figure B-2. Changes in the shape of the S-curve result in different brightness levels for the same
echo levels. Notice how the positions of the original brightness levels B–, Bo and B+ have moved
to B–1, Bo1 and B+1.

Changes in the system response can be identified by measuring the average pixel value of the grey
scale targets and the background material. Pixel values can be estimated qualitatively by eye. They
are measured with image analysis tools provided on some ultrasound instruments or from
workstations associated with PACS systems.

Harmonic Imaging 23
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24 Appendix A:. Harmonic Imaging

 Appendix B: Regulatory Supplement
In addition to the regulatory information contained in the body of this manual, the following
supplemental regulatory information is provided.

Symbols

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

WARNING: This symbol indicates a hazard that could result in major

injury or equipment damage.

Consult instructions for use.

Note: Important or supporting information.

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

Manufacturer’s Identification (name and address).

Date of Manufacture.

Serial Number.

Catalog Number.

Authorized representative in the European Community.

This symbol indicates conformity with EC Directives.

Operator Responsibility

The instructions in this manual are intended for trained personnel. The operator is solely responsible
for the accurate setup and use of the phantom.

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, Gammex's

Symbols 25
 Authorized European Representative:

Sun Nuclear GmbH

Martin-Behaim Str. 4-6, 63263
Neu-Isenburg - Germany

Any serious incident that has occurred in relation to this medical device should be
reported to the manufacturer and the competent authority of the Member State in which
the user is established;
Australian customers, contact Gammex’s Australian Sponsor:
alphaXRT Pty Ltd
Suite 1.15, 90-96 Bourke Road,
Alexandria, NSW, 2015, Australia

Modifications to Equipment

WARNING: No modifications may be made to this unit without the

expressed written consent of Gammex. Unauthorized changes may
present a risk to user or patients and will void the warranty

26 Appendix B:. Regulatory Supplement

This page is intentionally left blank.

27
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