Cirs 053S User manual

Model 053S, 053L & 053L-EF
Tissue-Equivalent
Ultrasound Prostate Phantom
ZERDINE ® Inside
A registered trademark of CIRS
USER GUIDE
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900 Asbury Ave • Norfolk, Virginia 23513 • USA • Tel: [phone] • WWW.CIRSINC.COM

3
OVERVIEW
The CIRS Ultrasound Prostate Training Phantom is a multi-modality disposable
phantom developed for practicing procedures which involve scanning the prostate
with a rectal probe.
Gel formulations within the Model 053S & 053L are designed to minimize needle
tracking and to provide imaging contrast under CT, MRI, ultrasound and elastrogra-
phy.
The prostate along with structures simulating the rectal wall, seminal vesicles and
urethra is contained within an 11.5 x 7.0 x 9.5 cm clear acrylic container. A 3 mm
simulated perineal membrane enables various probes and surgical tools to be
inserted into the prostate.
This phantom is an ideal training device for ultrasound guided cryosurgery, radioac-
tive seed implantation, and needle biopsy.
The phantom is available with (053L) and without lesions (053S) and can be ordered
in either the standard side-re conguration or an alternate geometry optimized for
end-re probes (053L-EF).
PHANTOM SPECIFICATIONS
Background
Ultrasound appearance: anechoic
CT appearance: dark
MRI appearance: dark (T1 weighted)
Elastography: soft
Prostate
Dimensions: 5 cm x 4.5 cm x 4 cm
Ultrasound appearance: average
echogenicity
CT appearance: dark, slight contrast
with background
MRI appearance: bright (T1 weighted)
Elastography: soft, slight contrast with
background
Volume: 53cc
Seminal Vesicles
Dimensions: 7 mm Ø x 10 cm long
Imaging appearance is similar to
prostate
Urethra
Dimensions: 7 mm Ø
Ultrasound appearance: anechoic
CT appearance: dark, similar to prostate
MRI appearance: darker than prostate
(T1 weighted)
Elastography: stiffer than prostate
Rectal Wall
Dimensions: 6 cm x 11 cm x 0.5 cm
Imaging appearance is similar to urethra
Lesions (053L and 053L-EF Only)
Qty: 3
Dimensions: Approximately 10 mm Ø
Ultrasound appearance: hypoechoic
CT appearance: bright
MRI appearance: dark (T1 weighted)
Elastography: stiff
Perineal Membrane
3 mm thick Z-skinTM elastomer
(1) US Patent #5196343

4
4.5cm
1cm 5cm
1cm
.5cm
4cm
3.2cm
2.6cm
TOP VIEW
SIDE VIEW
PERINEAL
MEMBRANE
PROSTATE
URETHRA
URETHRA
SEMINAL
VESICLES
SEMINAL
VESICLES
RECTAL
WALL
PROBE OPENING
Model 053S Ultrasound Image Model 053L - Lesion Shown
053L MR (T1 Weighted)
4.5cm
5cm
TOP VIEW
SIDE VIEW
PERENIAL
MEMBRANE
PROSTATE
URETHRA
SEMINAL
VESICLES
1.2cm
SEMINAL
VESICLES
URETHRA
PROBE OPENING
053L CT

5
USE OF THE PHANTOM
1. Remove phantom from sealed polyethylene bag.
2. Remove protective tape from openings in the phantom.
3. Scan the prostate in the usual manner using adequate coupling gel. Avoid ex-
cessive force on the rectal wall to avoid tearing.
4. Prostate can be biopsied through rectal wall or through the urethane
perineal membrane.
5. The Prostate Phantom is also suitable for training in cryosurgical procedures,
radioactive seed implantation, and thermal ablation and other minimally invasive
procedures.
CLEANING THE PHANTOM
1. It is not essential to remove all coupling gel from the opening between uses. A
small amount of residual gel will protect the phantom from desiccation.
2. If you wish to clean the residual coupling gel from the rectal wall, you may gently
ush the rectal wall with water or a dilute bleach solution. Although the phantom
has anti-microbial agents inside it, the bleach may inhibit mold growth inside
the air-tight bag when the phantom is not in use.
3. Always store the phantom in an air-tight container when not in use. If using the
provided polyethylene bag, squeeze out as much air as possible before sealing
the bag.

6
HANDLING PRECAUTIONS AND END OF LIFE DISPOSAL
This phantom is a disposable product and is not designed for extended use. It can be reused; howev-
er, as with any disposable training device, it will continue to deteriorate with each additional puncture.
For maximum product lifetime, store the phantom in an airtight bag or container. Standard room
temperature and humidity is acceptable for storage. Sub-freezing temperatures should be avoided
during shipping, as the freeze-thaw cycle may damage housing integrity and displace the targets.
High temperatures may accelerate desiccation. If signs of weight loss are seen (such as a sunken
scanning surface), contact CIRS for assistance.
When not in use, the phantom must be stored in an air-tight container, such as
a ziplock bag to minimize desiccation. Warranty will not cover dehydration.
Technical questions should be referred to CIRS customer service at [phone].
This product contains Zerdine, a non-owing water-
based, polyacrylamide material which is fully sealed
within the phantom housing. Zerdine contains trace
amounts of 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 Zerdine containing trace monomer acrylamide
below levels necessary to cause adverse health effects. None the
less, it is advised to wear protective gloves if handling exposed
Zerdine gel. It is also advisable to wash hands and all surfaces with
soap and water after handling exposed Zerdine gel.
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.

7
WARRANTY
All standard CIRS products and accessories are warranted by CIRS against defects
in material and workmanship for a period as specied 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 tness, 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 modication.
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 MAYBE RETURNED TO:
CIRS
Receiving
900 Asbury Ave,
Norfolk, Virginia, 23513 USA
*Please note: once any device has been inserted into the phantom (such as biopsy needles, localization
wires, etc.) the 12 month warranty will not cover claims related to material desiccation or needle tracking.
PRODUCT WARRANTY PERIOD
Model 053S/ L/ L-EF - Tissue Equivalent Ultrasound
Prostate Phantom 12 Months*

©
2013 Computerized Imaging Reference Systems, Inc. All rights reserved.
Specications subject to change without notice.
Publication: 053S/L/L-EF UG 072020
Computerized Imaging Reference Systems, Inc. has
been certied by UL DQS Inc. to (ISO) 13485:2016.
Certicate 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