Cirs ZERDINE 049 User manual

USER GUIDE
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Elasticity QA Phantoms
Models 049 & 049A
900 Asbury Ave • Norfolk, Virginia 23513 • USA • Tel: [phone] • WWW.CIRSINC.COM
ZERDINE®Inside
A registered trademark of CIRS

TABLE OF CONTENTS
1 OVERVIEW 1
2 INSTRUCTIONS FOR USE 2
HANDLING AND CARE ��������������������������������������������������������������� 2
GENERAL GUIDELINES FOR PERFORMING MEASUREMENTS ������������������������� 3
ESTABLISHING A BASELINE ��������������������������������������������������������� 3
3 TESTING PROCEDURES 4
4 SPECIFICATIONS- MODEL 049 5
5 SPECIFICATIONS- MODEL 049A 7
6 ZERDINE® 8
7 WARRANTY 9

1
Overview
The Model 049 and 049A Elasticity
QA Phantoms are elasticity reference
tools developed for both shear wave
and compression elastography. The
phantoms contain targets of known
stiffness relative to the background
material and range in stiffness, diam-
eter and depth.
Both phantoms are made of CIRS'
proprietary Zerdine®hydrogel poly-
mer, which has been formulated to
produce lesions of differing Young’s
modulus. To maximize phantom
lifetime, this gel is contained in a rugged ABS plastic housing with a Saran-based
laminate membrane.
The Model 049 Elasticity QA Phantom contains 10 mm and 20 mm diameter
spheres of varying hardness relative to the background material. The spheres are
located at depths of 15 mm and 35 mm respectively and will appear hyperechoic to
the background using standard B-mode imaging.
The Model 049A contains sets of stepped cylinders that vary in diameter from 1.6
mm to 16.7mm. The stepped cylinders in each set are located at depths of 3 cm
and 6 cm. Each set has a different hardness relative to the background material and
will appear almost isoechoic to the background using standard B-mode imaging.
CIRS is certified to ISO 13485:2016 standards. We have an in-house test facility to
measure acoustic properties of speed, attenuation and relative contrast. In addi-
tion, two ultrasound systems are used to visually inspect each phantom. As a result,
every ultrasound phantom is subjected to rigorous testing both during manufacture
and upon completion. The user may observe very minor imperfections within the
product such as: very slight inhomogeneities with the background speckle pattern
and only seen under certain conditions or a very small air bubble in a place that
does not impact utility or integrity of the phantom. Any such anomalies have been
determined, by CIRS engineers, to not impact the quality, performance or usability
of the product and are deemed “aesthetic imperfections”. The embedded lesions
may contain random inhomogeneities. Such inhomogeneities may prove useful in
demonstrating the ability of sonoelastography techniques to discriminate subtle
differences in material properties. A Certificate of Compliance is issued with each
phantom.
Models 049 & 049A are
Suitable for:
• Determining dynamic range
• Checking system performance
over time
• Training and demonstrating of
system features
• Research and development

2
INSTRUCTIONS FOR USE
HANDLING AND CARE
With proper care, the Model 049 and 049A will withstand years of normal use.
Below are some guidelines to follow.
The scanning surface is the most important item on the phantom to protect. It can
withstand normal scanning pressure but DO NOT press on the scanning surface
with your fingernails or any other sharp objects. If the scanning surface becomes
damaged, seal the phantom in an airtight container and IMMEDIATELY contact
CIRS for return authorization. Call 800-617-1177, email at [email protected] or fax
RMA Request form to 757-857-0523.
The phantom may be cleaned with mild soap and water ONLY. Avoid Solvent-
based, alcohol-based, or abrasive cleaning agents.
For longest life, the phantom should be cleaned after each use and stored at room
temperature in the provided carry case. The primary concern is gel desiccation due
to loss of water vapor through the membrane. In addition, the thermal stresses
associated with the freeze/thaw cycle may cause the gel to crack or damage the
housing integrity, while extreme heat may accelerate water vapor transmission
through the membrane. To minimize desiccation, always store the phantom in the
air-tight carry case with the removable storage cover attached.
Inspect your phantom regularly for signs of damage and weight loss. If any notice-
able changes to the phantom are detected, return the phantom IMMEDIATELY for
repair or replacement.
At least once a year, weigh your phantom and compare to original
weight noted on certificate of compliance. If the phantom has lost
or gained more than 1% of its original weight and you notice a
difference in vertical distance measurements, or the scan surface
appears depressed, call CIRS at [phone].
This product contains Zerdine, a non-flowing water-based, poly-
acrylamide material which is fully sealed within the phantom housing.
Zerdine contains trace amounts of the residual monomer acrylamide
CAS#79-06-1. There are no known hazards when the phantom
is used and stored as intended. Zerdine is fully cured and will not
leak from the housing. Damage to the integrity of the housing may
expose the user to trace amounts of acrylamide monomer. The
amount is not sufficient to pose an acute health risk, but it is still
advised to wear protective gloves if handling exposed Zerdine gel
due to the potential long-term hazards of the monomer. It is also
advisable to wash hands and all surfaces with soap and water after
handling exposed Zerdine gel.

3
Regulations regarding disposal of materials with trace acrylamide
monomer vary by locality. Contact your local authority for instruc-
tions. If assistance is desired in the proper disposal of this product,
including accessories and components, after its useful life, please
return to CIRS.
GENERAL GUIDELINES FOR PERFORMING MEASUREMENTS
It is recommended that all measurements be performed at the most frequently used
imaging arrangements. The importance of these tests is to make sure the system
performance remains constant over an extended period of time. Measurements
may also be used to compare the performance of various setups of the same ma-
chine or to compare different machines in a quantitative manner.
The following are general steps for imaging all targets:
• Some wires will appear as short lines rather than dots. When using the
electronic calipers, always take measurements from a point on one echo
to the same point on the next, i.e., center to center. Otherwise, errors may
be introduced.
• If a convex probe is used, center the target within the scan plane in order to
minimize degradation and distortion introduced on the outer edges of the
probe.
• When assessing vertical distance measurements, DO NOT press on the
scanning surface. Pressure on the scanning surface causes the wires
to become temporarily displaced, making vertical distance measure-
ments inaccurate.
• When assessing horizontal distance accuracy, ensure the scan plane is
perpendicular to the horizontal target group. Rotation of the probe will result
in inaccurate distances.
• Always be sure the phantom is scanned while at room temperature. A
phantom just received may be colder or hotter than room temperature de-
pending on where it was stored during shipping. Temperature affects the
speed of sound and, ultimately, the perceived measurements. The phantom
should be stored at room temperature for at least 24 hours before use to
ensure its core temperature is correct.
• The most accurate measurements will be made with the phantom 22˚C ±
1˚C (70˚F–73˚F).
HANDLING AND CARE (CONTINUED)

4
ESTABLISHING A BASELINE
Before performing routine quality assurance measurements, establish:
1. System settings for each measurement:
System setup can have a dramatic impact on the results obtained from quality as-
surance measurements. You must establish and record what system settings
should be used for each of the quality assurance tests. These same settings
should be used each time the test is performed. If not, then the conclusions
drawn may not be valid. CIRS recommends that you use the most commonly
used settings for the type of probe tested- i.e. the liver preset values for an abdominal
probe- which are called a "normal" technique in the sections that follow.
2. Baseline measurements:
The first set of measurements taken will be the baseline measurements for the
combination of system settings and phantom. Record the system settings and
phantom serial number used to acquire each measurement along with
your measurement results. On subsequent scans, refer to the baseline results
to determine if the ultrasound system has drifted to an unacceptable level. It is
each facility's responsibility to establish the magnitude of drift allowed
before corrective action is warranted.
3. Allowable deviation from baseline measurements:
The difference between the original baseline measurements and subsequent
measurement should be calculated and recorded. At some point the difference
will be large enough that some action is required (call service, replace system,
etc.). Each facility needs to determine the action level for each test. You should
refer to the user’s manual of your ultrasound scanner and note the stated
accuracies of the system’s general imaging measurements. These stated ac-
curacies may greatly influence the conclusion made when evaluating the ultra-
sound system. For example, if the measurement accuracy for your system
is 10% for distances up to 2 cm, the scanner may detect 2.0 cm as being any
where from 1.8 cm to 2.2 cm and still be functioning properly. The user is
responsible for establishing action levels.
4. Frequency of system assessment:
How often each system is evaluated is also up to each facility to determine.
CIRS recommends at least annually.
Reference the accreditation programs established by the ACR and AIUM at
www.acr.org or www.aium.org for further guidance on establishing a QA program.
TEST PROCEDURES
The Model 049 and 049A phantoms are designed as reference tools for perfor-
mance assessment and training in both shear wave and strain imaging elastogra-
phy.

5
Specifications - Model 049
TARGET LAYOUT
PHANTOM HOUSING
Material 1/4” Black ABS
Outer Dimensions 210 x 150 x 107 mm
SCANNING SURFACE
Material Saran-based laminate
MEMBRANE RETAINER
Material 1/16” Black ABS
Dimensions of scan opening 165 mm x 97 mm x 1/16”
REMOVABLE STORAGE COVER
Material 1/8” Black ABS
BACKGROUND MATERIAL
Material Zerdine
Speed of Sound 1540 m/s
30 30 30 30 30
TOP VIEW
15
35
FRONT VIEW
10mm Ø
20mm Ø
RIGHT END VIEW
Type I Type II Type III Type IV
Note that, due to differences in measurement methodology, the certified values for
Young’s modulus that are provided with the phantom may disagree with the values
measured with your system. For more information, see:
Oudry J, Lynch T, Vappou J, Sandrin L, Miette V. Phys Med Biol. Comparison of four different
techniques to evaluate the elastic properties of phantoms in elastography: is there a gold
standard? 2014 Oct

6
LESIONS
Material Zerdine
Speckle Contrast Hyperechoic to background
ELASTICITY1
Background 18
Lesion Type I 6
Lesion Type II 9
Lesion Type III 36
Lesion Type IV 70
10 MM DIAMETER LESION
Quantity 4 each at 15 mm depth
One of each hardness
20 MM DIAMETER LESION
Quantity 4 each at 35 mm depth
One of each hardness
ACCESSORIES
Carry case, Certificate of Compliance, Model 049 User Guide
NOTES
All dimensions without tolerances are nominal.
1Elasticity values will vary depending on the measurement of the system used.
Batch sample measurements, made using a quasi-static compression load frame,
are provided with the included certification sheet.
All measurements made at 22˚C ± 1˚C.

7
Specifications - Model 049A
TARGET LAYOUT
PHANTOM HOUSING
Material 1/4” Black ABS
Outer Dimensions 210 x 150 x 107 mm
SCANNING SURFACE
Material Saran-based laminate
MEMBRANE RETAINER
Material 1/16” Black ABS
Dimensions of scan opening 165 mm x 97 mm x 1/16”
REMOVABLE STORAGE COVER
Material 1/8” Black ABS
BACKGROUND MATERIAL
Material Zerdine
Speed of Sound 1540 m/s
LESIONS
Material Zerdine
Speckle Contrast Hyperechoic to background
TOP VIEW
120.0mm
180.0mm
30.0mm
60.0mm
95.0mm
SIDE VIEW
16.668mm (21/32”)
10.404mm (13/32”)
1.58mm (1/16”)
2.53mm (3/32”)
4.05mm (5/32”)
6.49mm (1/4”)
STEP TARGET
Type I Type II Type III Type IV

8
Zerdine®
The Model 049 and 049A is constructed from a patented, solid elastic material
developed at CIRS called Zerdine. Zerdine, unlike other phantom materials on the
market, is not affected by changes in temperature. It can be subjected to boiling
or freezing conditions without sustaining significant damage. Zerdine is also more
elastic than other materials and allows more pressure to be applied to the scanning
surface without subsequent damage to the material. At normal room temperatures,
Zerdine will accurately simulate the ultrasound characteristics found in human liver
tissue. Specific proprietary fabrication procedures enable close control over the
homogeneity of Zerdine and the reliability of its acoustic characteristics from batch
to batch.
The speed of sound in Zerdine can be adjusted between 1430 and 1650 meters
per second. The acoustic attenuation can be adjusted between 0.05 dB/cm-MHz
and 1.50 dB/cm-MHz. The relation between the acoustic attenuation, A, and the
acoustic frequency, F, is of the form A = AoFnwith values of the power coefficient, n,
in the range of 0.8 to 1.10, indicating the proportional increase of the acoustic at-
tenuation with frequency. Backscatter characteristics can be adjusted through the
addition of predetermined amounts of calibrated scatter material, and are fully com-
patible with harmonic imaging. Zerdine can be molded into very intricate shapes,
and the material can be cured in layers allowing the production of “multi-tissue”
phantoms. Zerdine, like most other phantom materials, will desiccate if unprotect-
ed; thus, all phantoms must be stored properly. If stored in the case provided, your
phantom should last many years.
ELASTICITY 2
Background 18
Lesion Type I 6
Lesion Type II 9
Lesion Type III 36
Lesion Type IV 70
STEPPED CYLINDERS
Quantity 8 Two of each hardness
Depths 3 & 6 cm deep
Diameters 1.6, 2.5, 4.1, 6.5, 10.4, 16.7 mm
ACCESSORIES
Carry case, Certificate of Compliance, Model 049A User Guide
NOTES
All dimensions without tolerances are nominal.
2Elasticity values will vary depending on the measurement of the system used.
Batch sample measurements, made using a quasi-static compression load frame,
are provided with the included certification sheet.
All measurements made at 22˚C ± 1˚C.
All speed of sound and attenuation measurements made with 5 MHz
focused transducer.

9
Warranty
All standard CIRS products and accessories are warranted by CIRS against defects
in material and workmanship for a period as specified below. During the warranty
period, the manufacturer will repair or, at its option, replace, at no charge, a product
containing such defect provided it is returned, transportation prepaid, to the manu-
facturer. Products repaired in warranty will be returned transportation prepaid.
There are no warranties, expressed or implied, including without limitation any im-
plied warranty of merchantability or fitness, which extend beyond the description on
the face hereof. This expressed warranty excludes coverage of, and does not pro-
vide relief for, incidental or consequential damages of any kind or nature, including
but not limited to loss of use, loss of sales or inconvenience. The exclusive remedy
of the purchaser is limited to repair, recalibration, or replacement of the product at
manufacturer’s option.
This warranty does not apply if the product, as determined by the manufacturer,
is defective because of normal wear, accident, misuse, or modification.
Non-Warranty Service
If repairs or replacement not covered by this warranty are required, a repair estimate
will be submitted for approval before proceeding with said repair or replacement.
Returns
If you are not satisfied with your purchase for any reason, please contact your local
distributor prior to returning the product. Visit https://www.cirsinc.com/distributors/
to find your local distributor. If you purchased your product direct through CIRS, call
Customer Service at 800-617-1177, email [email protected], or fax an RMA request
form to 757-857-0523. CIRS staff will attempt to remedy the issue via phone or
email as soon as possible. If unable to correct the problem, a return material
authorization (RMA) number will be issued. Non-standard or “customized” products
may not be returned for refund or exchange unless such product is deemed by
CIRS not to comply with documented order specifications. You must return the
product to CIRS within 30 calendar days of the issuance of the RMA. All returns
should be packed in the original cases and or packaging and must include any
accessories, manuals and documentation that shipped with the product. The RMA
number must be clearly indicated on the outside of each returned package. CIRS
recommends that you use a carrier that offers shipment tracking for all returns and
insure the full value of your package so that you are completely protected if the
shipment is lost or damaged in transit. If you choose not to use a carrier that offers
tracking or insure the product, you will be responsible for any loss or damage to the
product during shipping. CIRS will not be responsible for lost or damaged return
shipments. Return freight and insurance is to be pre-paid.
With RMA number, items may be returned to:
CIRS
Receiving
900 Asbury Ave,
Norfolk, Virginia, 23513 USA
Product Warranty Period
Models 049 & 049A - Elasticity QA Phantoms 48 Months

©
2013 Computerized Imaging Reference Systems, Inc. All rights
reserved. Specifications subject to change without notice.
Publication: 049 049A UG 030920
Computerized Imaging Reference Systems, Inc. has been
certified by UL DQS Inc. to (ISO) 13485:2016. Certificate
Registration No.10000905-MP2016.
COMPUTERIZED IMAGING
REFERENCE SYSTEMS, INC.
900 Asbury Ave
Norfolk, Virginia 23513 • USA
TOLL FREE 800.617.1177
TEL: [phone]
FAX: [phone]
EMAIL: [email protected]
www.cirsinc.com
Technical Assistance
1.800.617.1177