Cirs 059 User manual

OBJECTIVE
The Model 059 is a perfect demonstration tool for sonoelastography, because it ac-
curately mimics the ultrasonic characteristics of tissues found in an average human
breast.
PHANTOM DESCRIPTION
The size and shape of the phantom simulates that of an average patient in the
supine position.
A special holding tray facilitates proper hand position during the training proce-
dures.
Each phantom measures approximately 14 cm long x 12 cm wide x 7.5 cm high
with a volume of 600 cc. Within each phantom, there are 12 masses that are
approximately three times harder than the background material and are randomly
positioned. These lesions have minimal contrast with conventional ultrasound (hy-
poechoic relative to background), but will show up readily on elastograms.
SPECIFICATIONS
Size & Weight 600 cc (14 cm x 12 cm x 7.5 cm)
Tray Dimensions 22.5 cm x 20.0 cm
Material Zerdine®

USE OF THE PHANTOM
The phantom should not be removed from the white holding tray. The membrane
covering the phantom should never be removed. Each phantom contains 12 dense
masses which are blue in color. These targets are randomly placed and specically
designed for visualization with elastography and practicing core biopsy procedures.
Before imaging, be sure to place an ample amount of coupling gel on the probe or
the polyethylene membrane which covers the phantom.
The phantom can be punctured many times before being “tracked out”. Side to
side manipulation of the needle within the phantom can produce signicant echoic
artifacts because this motion tends to introduce air.
If the phantom needs to be stored after the membrane has been punctured, be
sure to place it in an air-tight container such as a ziplock bag. This will help avoid
desiccation.
CARE AND HANDLING
• This phantom is a disposable product and is not designed for extended
use. It can be reused; however, 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 contain-
er. 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 tempera-
tures may accelerate desiccation. If signs of weight loss are seen (such as a
sunken scanning surface), contact CIRS for assistance.
• Technical questions should be referred to CIRS customer service at (800) 617-
1177.

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 satised with your purchase for any reason, please contact Customer
Service or your local distributor prior to returning the product. Visit https://www.
cirsinc.com/distributors/ to nd your local distributor. Call 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 ex-
change unless such product is deemed by CIRS not to comply with documented
order specications. 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
*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 059 - Breast Elastography Phantom 12 Months*
©
2013 Computerized Imaging Reference Systems, Inc. All rights reserved.
Specications subject to change without notice.
Publication: 059 UG110920
Computerized Imaging Reference Systems, Inc. has been
certied by UL DQS Inc. to (ISO) 13485:2016. Certicate
Registration No.10000905-MP2016.