ATS 535-H User manual

MODEL 535-H
BASIC QUALITY ASSURANCE
PHANTOM
Revised
June 2014
ATS Laboratories, Incorporated
900 Asbury Ave
Norfolk, VA 23513
Tel: [phone] Email: [email protected]
Website: atslaboratories-phantoms.com

TABLE OF CONTENTS
Section Page
Introduction 3
Product Description 3
Tests Performed 3
Specifications 4
Model 535-H Target Diagram 5
Dead Zone 6
Vertical Measurement Calibration 6
Horizontal Measurement Calibration 7
Axial and Lateral Resolution 8
Focal Zone 8
Sensitivity (Maximum Depth of Penetration) 9
Functional Resolution, Definition and Fill-in 10
Care and Handling of Rubber Based Phantoms 11
Warranty 11
Sample Ultrasound Performance Record

INTRODUCTION
Quality assurance tissue-mimicking phantoms are used to evaluate the accuracy and performance of ultrasound
imaging systems. The phantoms mimic the acoustic properties of human tissue and provide test structures within
the simulated environment. They are essential to detect the performance changes that occur through normal
aging and deterioration of system components. Routine equipment performance monitoring can reduce the
number of repeat examinations, the duration of examinations and maintenance time.
This phantom is constructed of a new rubber-based tissue-mimicking material developed by ATS Laboratories.
This material extends the useful life of the phantom by avoiding problems due to melting, freezing, dehydration
and breakage from dropping which are common with hydrogel (water-based) phantoms. By eliminating these
problems, the durability, quality and reliability of this product is guaranteed for three years.
The acoustic properties of all biologic and non-biologic materials are affected by temperature variations. Most
diagnostic imaging systems and tissue-mimicking phantoms are calibrated at room temperature, commonly
referred to as 23°C. To ensure measurement accuracy ATS incorporates a thermometer strip affixed to the outside
surface of the phantom housing.
The sound velocity of most diagnostic imaging systems is calibrated to 1,540 meters per second (mps), the
assumed average velocity of sound through human soft tissue. The rubber-based tissue-mimicking material has a
sound velocity of 1450 mps at 0.5dB/cm/Mhz at room temperature (23°C). The line targets and anechoic target
structures have been physically positioned to compensate for the differences in the speed of sound, assuring
accuracy of measurements.
PRODUCT DESCRIPTION
The Model 535-H rubber-based, tissue-mimicking (TM) phantom is designed to fulfill the basic testing
requirements of a Quality Assurance Program.
The phantom is designed with a combination of monofilament line targets and six tissue mimicking cylindrical
targets of varying sizes. The monofilament line targets have a diameter of 0.12 mm, to optimize the displayed
image at frequencies ranging from 2.25 to 7.5 MHz. Four groups of line targets are provided to evaluate the
vertical and horizontal calibration measurements, axial-lateral resolution and the dead zone.
TESTS PERFORMED
·Dead Zone or Transducer Ring-Down
·Vertical Measurement Calibration
·Horizontal Measurement Calibration
·Focal Zone
·Sensitivity
·Axial & Lateral Resolution
·Functional Resolution, Definition and Fill-In

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Scan Surface 1
Scan Surface 3
Scan Surface 2
Scan Surface 4

SPECIFICATIONS
GENERAL
Overall Dimensions: 23.4 x 209 x 9.5 cm*
Weight: 3.1 Kg*
Housing Material: PVC
Wall Thickness: 1.0 cm*
Scan Surfaces: 4
Scan Surface Dimensions: 17.5 x cm*
19 x 8 cm*
TISSUE MIMICKING MATERIAL
Type: Urethane rubber
Freezing Point: < -40°C
Melting Point:
Attenuation Coefficient:
Speed of Sound:
> 100°C
0.5 dB/cm/MHz (measured at 3.5 MHz)
1450 mps at 23°
LINE TARGETS
Material: Monofilament Nylon
Diameter: 0.12 mm
Vertical Group:
Number of Targets: 17
Interval Spacing: 1 cm
Depth: 1 - 17 cm
Horizontal Group:
Number of Targets: 10
Number of Groups: 2
Interval Spacing: 2 cm
Depth: 5 cm from Scanning Surface #1
5 cm from Scanning Surface #3
Dead Zone Group:
Number of Targets: 9
Lateral Displacement: 5 mm
Interval Spacing: 1 mm
Depth: 2 - 10 mm
Axial-Lateral Resolution Group:
Number of Targets: 6
Lateral Displacement: 1.0 mm
Interval Spacing: 5, 4, 3, 2, 1 mm
Axial Depths: 5.5 & 11 cm
Lateral Depths: 4.5 & 16.5 cm
ANECHOIC TARGET STRUCTURES
Type: Non-echogenic, cylindrical
Number of Targets: 6
Diameters: 4, 8, 10 mm
Interval Spacing 1.0 cm
Depth: 3, 5, 13 cm
WARRANTY: Lifetime
*Nominal dimensions

DEAD ZONE
Description and Reason For Testing
The dead zone is the distance from the front face of the transducer to the first identifiable echo at the
phantom/patient interface. In the region of the dead zone no clinical data can be collected. The dead zone
occurs because an imaging system cannot send and receive data at the same time. The depth of the
dead zone depends upon the frequency and performance of the transducer and the pulsing/receiving
section of the system.
Testing Procedure
1. Place the phantom on a clean, flat surface with scanning surface #1 positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal"
liver scanning. If the bottom of the phantom is visualized, adjust the gain settings until the
image goes entirely black. Record these settings on the quality assurance record. These
setting should be used for subsequent testing.
4. Scan the phantom until the dead zone target group is clearly displayed. Freeze this image.
5. This group is composed of 9 line targets. The first target is positioned 2 mm below the scan
surface. Subsequent targets are spaced 1 mm apart, to a depth of 10 mm.
6. Using the electronic calipers, measure the distance between the first target imaged and the
echo produced by the scan surface. The resulting value will be the depth of the dead zone.
7. Document the depth measurement on the quality assurance record.
Results
If the depth of the dead zone is greater than 10.0 mm, corrective action should be considered by the
individual Ultrasound Department.
VERTICAL MEASUREMENT CALIBRATION
Description and Reason For Testing
Vertical distance measurements are obtained along the axis of the sound beam. Proper diagnosis is
dependent upon accurate representation of the size, depth and volume of structures being examined.
Most imaging systems use depth markers and/or electronic calipers to obtain these measurements. The
vertical line targets are scanned and a distance measurement obtained. The resulting measurement is
then compared to the known distance between the line targets in the phantom. The accuracy of vertical
distance measurements is dependent upon the integrity of the timing circuitry of the imaging system.
Testing Procedure
1. Place the phantom on a clean, flat surface with scanning surface #1 positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used,
fill the scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal"
liver scanning. If the bottom of the phantom is seen, adjust the gain settings until the image
goes entirely black. Record these settings on the quality assurance record. These setting
should be used for subsequent testing.
4. Position the transducer over the vertical group of line targets until a clear image is obtained.
Freeze the display.

5. Using the electronic calipers or the timing markers measure the greatest distance that can be
clearly imaged between line targets.
6. Document the measurement obtained on the quality assurance record.
Results
Vertical Spacing: 1.0 cm center to center ± 0.1 mm
If a discrepancy occurs which is greater than 1.0 mm, corrective action should be considered by the
individual Ultrasound Department.
HORIZONTAL MEASUREMENT CALIBRATION
Description and Reason For Testing
Horizontal distance measurements are obtained perpendicular to the axis of the sound beam. Proper
diagnosis is dependent upon the accurate representation of the size and volume of a structure being
examined. Most imaging systems use distance markers and/or electronic calipers to obtain these
measurements. The phantom is scanned and a distance measurement obtained. The resulting
measurement is then compared to the known distance in the phantom. The accuracy of the horizontal
distance measurements is dependent upon the integrity of the transducer, the output intensity and the
resolution of the imaging system.
Testing Procedure
Note: The Model 535-H Basic QA phantom provides two scanning surfaces used to evaluate horizontal
measurement calibration. Linear array scanning systems should use #1 scanning surfaces. Sector
scanning systems should use #3 scanning surfaces.
1. Place the phantom on a clean, flat surface.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used,
fill the scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal"
liver scanning. If the bottom of the phantom is seen, adjust the gain settings until the image
goes entirely black. Record these settings on the quality assurance record. These settings
should be used for subsequent testing.
4. Position the transducer over the horizontal group of line targets until a clear image is obtained.
Freeze the image.
5. Using the electronic calipers or the timing markers measure the greatest distance that can be
clearly imaged between line targets displayed.
6. Note: Some sector scanners have distance markers on the outside edges of the sector image
with no other indicators available. Hand-held calipers must be used for distance
measurements within the image on the monitor.
7. Document all of the measurements on the quality assurance record.
Results
Interval Spacing: 2 cm ± 1 mm
Depths: 5 cm ±.1 mm (Scan surface #1)
5 cm ±.1 mm (Scan surface #3)
If a discrepancy occurs which is greater than 2 mm, corrective action should be considered by the
individual Ultrasound Department.

AXIAL AND LATERAL RESOLUTION
Description and Reason For Testing
Resolution is the minimum reflector separation between two closely spaced objects which can be imaged
separately. If a system has poor resolution capabilities, small structures lying close to each other will
appear as one image, causing improper interpretation of the ultrasound findings.
Resolution along the axis of the sound beam is referred to as Axial Resolution. Axial Resolution is
affected by the pulsing section of the imaging system and the condition of the transducer.
Resolution perpendicular to the axis of the sound beam is termed Lateral Resolution. Lateral Resolution
is dependent upon the beam width, increased beam width will reduce the Lateral Resolution.
Testing Procedure
In the Model 535-H scan surface #1 and #3 are used to evaluate axial resolution at depths of 5.5 and 11
cm. To evaluate lateral resolution, scan surfaces #2 and #4 are used, at depths of 4.5 and 16.5 cm.
The interval spacing of the line targets are 5, 4, 3, 3, and 1 mm. Each target is spaced 1 mm laterally to
avoid over shadowing of the adjacent targets.
1. Place the phantom on a clean, flat surface with scanning surface #1 positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used, fill the
scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal" liver
scanning. If the bottom of the phantom is seen, adjust the gain settings until image goes entirely black.
Record these settings on the quality assurance record. These settings should be used for subsequent
testing.
4. Position the transducer over the axial resolution group of line targets on the phantom until a clear
image is obtained. Freeze this image.
5. Examine the image to determine if all of the line targets within the group are clearly displayed as
separate target points. Record the closest spaced target points which can be imaged (refer to
specification drawing). Obtain a hard copy of the display.
6. Document all observations made on the quality assurance record.
7. Position the phantom with scan surface #3 ready for use. Repeat steps 2-5.
8. Repeat steps 1-6 for scan surfaces #2 and #4 to obtain measurements of the lateral resolution.
Results
The system's ability to resolve the array targets at all four depths should remain consistent from week to
week when using the same instrument settings and the Model 535-H phantom. Compare the test results
obtained with a baseline or previous test. If the current image demonstrates changes in the system's
ability to resolve these targets, corrective action should be considered.
FOCAL ZONE
Description and Reason For Testing
The focal zone is the region surrounding the focal point in which the intensity and the lateral resolution is
the greatest. Clinically, structures examined within the focal zone will provide the best diagnostic
information obtainable. The focal zone can be affected by changes in the pulsing/receiving section of the
imaging system or damage to the transducer.

Testing Procedure
1. Place the phantom on a clean, flat surface with #1 scanning surface positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used,
fill the scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal"
liver scanning. If the bottom of the phantom is seen, adjust the gain settings until image goes
entirely black. Record these settings on the quality assurance record. These settings should
be used for subsequent testing.
4. Position the transducer over the vertical group of line targets on the phantom, until a clear
image is obtained. Freeze the display and obtain a hard copy.
NOTE: A line rather than a dot is produced on the display. The length of the line is indicative of
the width of the beam. Therefore, targets inside the focal zone form a shorter line than those
outside of the focal zone. Adjustments in the gain settings will change the length of the line
targets displayed.
5. For a variable focused transducer, scans with several different focal zone settings should be
performed. Dynamically focused transducers may not display changes in the width of the line
targets. However a change in the intensity can be observed upon adjustment of the
transmitting focus of the transducer.
6. Using the hard copy, draw a line connecting the ends of the echoes received from the line
targets (both sides), the line should form a smooth curve. This will illustrate the shape of the
sound beam. Now locate the narrowest portion, this is the focal zone. Measure the width of
the beam and the depth at this point.
7. Document the depth of the focal zone and the measurement of the focal width on the quality
assurance record.
Results
The location of the focal zone should agree with the manufacturer's specifications and should not change
with time. This applies to both fixed and dynamically focused systems. If changes occur corrective action
should be considered.
SENSITIVITY (MAXIMUM DEPTH OF PENETRATION)
Description and Reason For Testing
The ability of an imaging system to detect and display weak echoes from small objects located at
specified depths (penetration) is referred to as sensitivity. Clinically, weak reflecting echoes are commonly
produced from internal structures of organs. Definition of these structures can be extremely important in
the interpretation of the ultrasound findings. Sensitivity can be affected by the pulser/receiver section of
the system, the degree of focusing of the transducer, attenuation of the medium, depth and shape
(geometry) of the reflecting object, and electromagnetic interference from the local surroundings.
Testing Procedure
The Model 535-H is provided with two sets of anechoic target structures, at two depths from scan surface #1. The
ability to use all four scanning surfaces allows measurements to be obtained at 6 depths.
1. Place the phantom on a clean, flat surface with #1 scanning surface positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used, fill the
scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal" liver
scanning. If the bottom of the phantom is seen, adjust the gain settings until image goes entirely black.

Record these settings on the quality assurance record. These settings should be used for subsequent
testing.
Note: In addition to the above, this test should also be performed with output levels set at the highest and
lowest settings. This enables any changes in output to be more easily detected.
4. Position the transducer over the two 10 mm anechoic targets. This surface provides measurements at
depths of 3 and 13 cm.
5. Freeze image and obtain a hard copy.
6. Repeat steps 1-5 for the remaining scan surfaces, to provide measurements at remaining scanning
depths.
7. Examine the image to determine the last or deepest target structure displayed. Using the electronic
calipers or the timing markers measure the depth of this target.
8. Document the depth measurement on the quality assurance record.
Results
The depth of penetration should not shift by more than 1.0 cm, when using this phantom at same
instrument settings and transducer. If a discrepancy occurs corrective action should be considered by the
individual Ultrasound Department.
FUNCTIONAL RESOLUTION, DEFINITION AND FILL-IN
Description and Reason For Testing
Functional resolution is an imaging system's ability to detect and display the size, shape, and depth of an
anechoic structure within the test phantom. In practice, the data obtained will give a direct indication of
the minimum size structure the system is capable of resolving at a given depth.
Definition and Fill-in describes the imaging system's ability to detect and display the shape and echogenic
characteristics of a structure. Clinically, a correct diagnosis is dependent upon the system's ability to
differentiate between a cystic or solid structure versus echo patterns originating from the surrounding
normal tissue.
Testing Procedure
The Model 535-H is provided with two sets of anechoic target structures, at two depths from scan surface
#1. The ability to use all four scanning surfaces allows measurements to be obtained at 6 depths.
1. Place the phantom on a clean, flat surface with scanning surface #1 positioned for use.
2. Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used,
fill the scanning well slowly to avoid introduction of air bubbles.
3. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal"
liver scanning. If the bottom of the phantom is seen, adjust the gain settings until image goes
entirely black. Record these settings on the quality assurance record. These settings should
be used for subsequent testing.
4. Position the transducer over the anechoic circular target group on the phantom, until a clear
image is obtained.
5. Freeze image and obtain a hard copy.
6. Repeat steps 1-5 with the remaining 3 scan surfaces.
7. Examine the images obtained to determine the smallest target visualized at the shortest and
longest depths. Due to the configuration of the sound beam small targets in the near field may
not be imaged.

8. All findings should be documented on the quality assurance record.
Results
The targets should appear circular with sharp clearly defined edges, indicating an abrupt transition from
the echogenic to the anechoic region. The targets are anechoic and should be free of any internal echoes
or fill-in. However, the presence of internal system noise may manifest itself by producing an observable
shade of gray within the target area.
The specific values determined, while significant in their own right, are somewhat less important than
stability over time. Performing this test on a routine basis at the same instrument settings should produce
the same results. Any changes should be investigated.
CARE RUBBER-BASED PHANTOMS
For best results the phantom should be kept clean at all times and stored at room temperature. In
particular a build-up of dried coupling gel on the scan surface should be avoided. The phantom may be
cleaned with warm water using a lint free cloth. Particularly stubborn stains and dirt may be removed with
a mild household cleaner. The use of petroleum solvents should be avoided since they may adversely
react with the rubber-based material.
WARRANTY
Statement of Warranty:
ATS Laboratories, Incorporated warrants this rubber-based phantom for it’s lifetime from the date of
delivery to the purchaser, that the Phantom is free from functional defects in materials and workmanship.
The lifetime of this phantom is estimated to be 10 years from the date of manufacturing. If ATS
Laboratories, Incorporated, deems the phantom to be defective, at its sole option, the Phantom will be
repaired or replaced free of charge, in a reasonable amount of time.
ATS shall not be otherwise liable for any damages, including but not limited to incidental damages,
consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties as stated below.
Conditions of Warranty:
1. The defect must be reported and the Phantom returned within the warranty period.
2. The Phantom must be packaged properly to avoid damage during shipping.
3. All transportation charges will be paid by the purchaser.
Invalidation of Warranty:
1. If the phantom has been altered or repaired other than by ATS Laboratories, Incorporated.
2. If the phantom has been subject to abuse, misuse, negligence or accident.
3. If the purchaser has exposed the Phantom to petroleum solvents.