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)