Gammex Phantom 404 LE User manual

404 LE
Precision Small Parts
Phantom
User’s Guide

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Table of Contents
Introduction.......................................................................................3
Caring for your 404 LE......................................................................4
Scanning your 404 LE.......................................................................5
A Guided Tour of your 404 LE...........................................................6
Evaluating the Phantom....................................................................7
Target Configuration........................................................................11
Cystic Targets..................................................................................11
Pin Targets......................................................................................11
Resolution Target Groups..................................................................11
Phantom Specifications..................................................................13
Physical Specifications...................................................................13
Tissue Mimicking Background Material..........................................13
Harmonic Imaging..........................................................................14
Phantom Desiccation.....................................................................15
Charts and Graphs........................................................................15
Product Warranty...........................................................................16
Sales and Service..........................................................................17

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Introduction
The 404 LE phantoms are designed to measure the image quality of high frequency trans-
ducers and intra-cavity ultrasound scanning systems. These Precision Small Parts Phan-
toms permit precise measurements of resolution for testing the following image indicators:
• Dead zone
• Axial and lateral resolution at various depths
• Cyst imaging
• Accuracy of electronic calipers
• Depth of penetration
• Image uniformity
• Vertical and horizontal distance calibration
• Focal zone registration
The 404 LE uses a tissue mimicking gel that provides a smoother background texture and
a composite film scanning surface that maximizes the ultrasonic beam transmission.
Limitations of Use
The 404 LE is designed to be used to aid in the Quality Control testing and monitoring of
ultrasound instruments only. The 404 LE is not to be used to make diagnostic decisions.

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Caring for your 404 LE
Phantom comes ready to scan. Do not remove surface material.
Store your 404 LE with water dam and cover closed securely.
Always attach the scanning surface cover and store the phantom out of direct sunlight
when it is not in use.
Store your 404 LE at 35º-105ºF (2º-40ºC).
Freezing temperatures will damage the phantom and high temperatures will accelerate
desiccation.
Weigh your 404 LE to monitor desiccation.
Weigh the phantom when you first receive it and then every 6 months. Record the values
on the data sheet.
Do not drop or damage the phantom.
Return the phantom for inspection and/or repair if it has been dropped or damaged.
Physical damage to the case will cause premature desiccation.
Gammex recommends annual servicing of your 404LE to ensure proper operation. Our
qualified service technicians will check for desiccation and provide any needed
rejuvenation, scanning/certification to original specifications, and repairs.

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Scanning your 404 LE
• Always place the phantom on a stable, level surface for scanning.
•The phantom comes ready to scan. Do not peel off the surface material.
•Do not press the transducer into the scanning surface. This damages the
scanning surface and will shorten the life of the phantom. For curved transducers, use
water or a layer of gel.
• Use water or a generous amount of coupling gel to ensure good transmission. Do
not use mineral oil, baby oil or lanolin-based gels as a coupling medium. Poor transmis-
sion is a result of insufficient coupling.
• Clean the scanning surface immediately after use. Use a soft cloth or paper towel
and soap and water, if needed.
Caution:
Do not press the transducer
into the scanning surface.

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A Guided Tour of your 404 LE
The Precision Small Parts Phantom 404 LE is an instrument for measuring the image
quality of small parts and intra-cavity ultrasound scanning systems. The tissue
mimicking gel in the 404 LE is ultrasonically similar to human tissue. This allows the
use of normal scanner control settings and ensures that the performance measured
with the phantom closely approximates the scanner’s performance in a clinical
examination.
Scanning is the best way to familiarize yourself with the features and functions of the
404 LE. A guided tour of the phantom is provided on the following pages.

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Evaluating the Phantom
Remember
A 4.5 MHz probe will provide a good overall view of the phantom for this demonstration.
1. Turn the handle out of the way and slide the cover off the phantom.
2. To couple with water, fill the dam with distilled water. For a better image quality,
use gel.
3. Rest the transducer on the scanning surface. Adjust the scanner to display the
full depth of the phantom.
You may notice that the tissue echoes near the bottom of the phantom fade into noise.
The depth at which usable echoes disappear is called the depth of penetration. The
depth markers on the phantom label will help you determine the depths of the targets.
•The phantom comes ready to scan. Do not peel off the
surface material.
•Never press the transducer into the scanning surface.
• Always clean and dry the scanning surface after each use.
Never leave coupling gel or water on the scanning surface
for more than a few hours.
•Do not use mineral oil, baby oil, or lanolin-based gels as a
coupling medium.

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4. Move the transducer across the scanning surface while observing the locations
of the targets.
Notice how the smooth texture of the tissue mimicking gel emphasizes image
non-uniformities and artifacts, making them easier to detect. Scanning an area
without targets is a good way to test for image uniformity.
Decrease gain controls to highlight pin targets.
5. Scan the vertical pin targets and freeze the image. Use the electronic calipers to
measure the distance between two of the vertical pin targets. Repeat for two of
the horizontal pin targets. The vertical pins have 5 mm spacing while the
horizontal pins have 10 mm spacing.
Use the pin targets to determine vertical distance accuracy and horizontal
distance accuracy. Note that the highest dead zone pin you can see should be
the point of reference not the scanning surface.
6. Freeze an image of the vertical pin targets. Use the electronic calipers to
measure the horizontal width of the pin targets in the near, mid and far fields of
the image.
Notice how the pin targets are narrowest in the focal zone. The pin width
demonstrates the width of the ultrasound beam at that depth and approximates
the lateral resolution of the scanner.

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7. Decrease the image depth and examine the axial resolution target group at 1 cm.
Notice how the images of the lower pin targets may begin to merge. The smallest
distance between two pins that can be clearly resolved with no vertical overlap is
called the scanner’s axial resolution.
Examine the other axial resolution target groups and compare the resolution at
various depths. Axial resolution may change with depth.
8. Scan the nearest cystic target group. Each target should be round with a clean
black appearance and well defined edges. Bright specular echoes at the top and
bottom of the targets are normal.
Unresolved Resolved
Pin target are resolved axially if an imaginary horizontal line can be drawn
between the targets without touching either target. The targets on the left are not
resolved. The targets on the right are resolved.

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Measure the dimensions of the 4 mm cystic target to check the image geometry.
Use the calipers to measure from top to bottom and side to side. Repeat with the
other cystic target groups as part of the cyst imaging test.
9. Decrease image depth to the minimum and examine the dead zone target group.
The dead zone targets can also be used to measure lateral resolution in the
extreme near field of the transducer.
Note: The highest dead zone pin you can see should be the point of
reference for all measurements – not the scanning surface.
10. When you are done scanning the phantom, empty the water dam or completely
clean off the coupling gel with a soft cloth or paper towel. Replace the cover and
secure by lifting the handle to protect the phantom.

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Target Configuration
Cystic Targets
Diameters............................................................................................1, 2 and 4 mm
Placement.................................................................................1, 3.5 and 6 cm deep
Pin Targets
Diameter........................................................................................................0.1 mm
Vertical spacing................................................................... 5 mm at 1 to 9 cm deep
Horizontal spacing...........................................................10 mm at 1 and 5 cm deep
Resolution Target Group
...........................................................................1, 3.5 and 6 cm deep
All acoustic measurements made at 4.5 MHz, 22ºC.
Due to our philosophy of continuous quality improvement,
all specifications are subject to change.

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13
Phantom Specifications
Physical Specifications
Weight..............................................................Approx. 1.75 kg (3 lbs. 13 oz.)
Dimensions.......................................................................11.4 x 17 x 8.25 cm
(4.50 x 6.75 x 3.25 in.)
Scanning surface......................................................................Composite film
Case material.................................................................................ABS plastic
Pin target material........................................................... Nylon monofilament
Tissue Mimicking Background Material
Water-based gel with appearance of human tissue.
Speed of sound...........................................................................1540±10 m/s
All acoustic measurements made at 4.5 MHz, 22ºC.
Due to our philosophy of continuous quality improvement,
all specifications are subject to change.

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Harmonic Imaging
Harmonic imaging has become an important addition to the medical ultrasound
community. Harmonic imaging is when a pulse is sent from the transducer at a nominal
(fundamental) frequency, but the signal received by the transducer is twice that
frequency, which is the second harmonic. The result is that better resolution is attained
at any given depth than if the reception had been at the fundamental frequency, as in
conventional ultrasound.
There are three tissue properties that determine the effectiveness of harmonic imaging:
1. pulse propagation speed
2. attenuation (rate of pulse energy loss with depth)
3. the value of a thermodynamic parameter: B/A
In order for phantoms to present valid resolution results for harmonic imaging, these
three properties must adequately correspond to human tissue. Attenuation increases
with frequency and much of the propagation involves the fundamental frequency, so in
harmonic imaging, there is enhanced resolution without as much attenuation as there
would be if the higher frequency were used to generate the pulses at the transducer. So,
higher frequency resolution occurs for greater depths within the subject than if
conventional ultrasound was used.
The ratio of B/A quantifies the rate of transfer with respect to propagation distance of
ultrasonic fundamental frequency energy to harmonic frequencies. The greater the
amplitude, the greater the energy transfer rate; thus, the beam profile for the harmonic is
smaller than for the fundamental, which means better lateral and elevational resolution.
Tissue-mimicking phantoms will be appropriate for assessing harmonic imaging only if
B/A for the tissue-mimicking material in the phantom adequately approximates that of
soft tissues. Recently, we have developed the capacity to measure the value of B/A for
the tissue-mimicking materials in Gammex phantoms and have found it to lie in the
range for human soft tissue, meaning B/A is between 6 and 71.
______________________________________
1Gong, X. F., Zhu, Z. M., Shi, T., Huang, J. H. (1989) Determination of the
acoustic nonlinearity parameter in biological media using FAIS and ITD methods, J.
Acoust. Soc. Am. 86 (1), pp 1-5.

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Phantom Desiccation
Over time, the phantom’s water-based gel will slowly lose moisture. This process is ac-
celerated by high temperatures, incorrect storage, and damage to the case or scanning
surface. Consistently storing the phantom in an air-tight container will contribute greatly
to long phantom life. A properly stored phantom will reduce the amount of moisture lost
per year.
For most climate-controlled environments, the phantom weight should be checked every
six months. Phantoms used in high temperatures/low humidity environments or in mo-
bile situations should be tested more frequently. As the phantom desiccates, the scan-
ning surface may flatten out. It is suggested that the phantom be sent in for rejuvenation
once it has lost 15 grams of its total weight. When this occurs, contact GAMMEX
(1-800-GAMMEX-1).
Charts and Graphs
Refer to the Charts and Graphs section of the manual to find the appropriate charts and
graphs for your 404 LE phantom, which include:
Data Sheet
Phantom Weight Chart

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Product Warranty
WARRANTY, DISCLAIMERS AND LIMITATION OF LIABILITY:
The Products are covered by the warranty set forth in the following paragraphs. The warranty is
extended only to the purchaser of the Products directly from Seller (or an authorized dealer of
Seller) as new merchandise. For a period of twelve (12) months from the date of original delivery
to Buyer, the Products are warranted to be free from functional defects in materials and work-
manship, provided they are operated under condition of normal use, and that repairs and re-
placements are made in accordance herewith. Seller does not warrant bulbs. The foregoing
warranty shall not apply to Products that have been disassembled, altered or repaired (other
than proper replacement bulbs) other than by Seller or if the Product has been subject to abuse,
misuse, negligence or accident.
Seller’s sole and exclusive warranty obligation and Buyer’s sole and exclusive warranty consists
of Seller, at its option, repairing or replacing free or charge Products: (a) which contain a defect
covered by the above warranty; (b) which are reported in writing to Seller not later than seven
(7) days after the expiration of the warranty period; (c) which are returned to Seller promptly
after discovery of the defect; and (d) which are found to be defective by Seller upon Seller’s ex-
amination. Buyer shall pay all transportation charges. SELLER SHALL NOT BE OTHERWISE
LIABLE FOR ANY DAMAGES, INCLUDING BUT NOT LIMITED TO INCIDENTAL DAMAGES,
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GENCE, PROMISSORY, ESTOPPEL, STRICT LIABILITY, MISREPRESENTATION, TORT)
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THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE
WARRANTIES SET FORTH ABOVE. SELLER MAKE NO WARRANTY OF MERCHANTABIL-
ITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS OR
ANY PARTS THEREOF.
© 2003 GAMMEX 006225-00-05
Your warranty may be registered at http://www.gammex.com/warranty.asp

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Sales and Service
GAMMEX is committed to satisfying our customer’s needs. If you have any questions,
comments, or suggestions regarding our products and service, please call or fax us.
Sales Department hours are Monday through Friday, 7:30 am to 5:00 pm Central Time.
1-800-GAMMEX-1 (426-6391)
1-608-828-7000
1-608-828-7500 Fax
e-mail: [email protected]
Service Department hours are Monday through Friday, 7:30 am to 5:00 pm Central
Time.
1-800-232-9699
1-608-828-7000
1-608-828-7500 Fax
e-mail: [email protected]
GAMMEX, Inc.
7600 Discovery Drive
P.O. Box 620327
Middleton, WI 53562-0327 U.S.A.
http://www.gammex.com

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Notes:

19
Notes:

Gammex, Inc.
P.O. Box 620327
Middleton, WI 53562-0327 USA
1 800 GAMMEX 1 (426-6391)
1 608 828 7000
Fax: [phone]
www.gammex.com
e-mail: [email protected]
Gammex-RMI LTD
Broadway Business Centre
32A Stoney Street
Nottingham NG1 1LL
United Kingdom
[phone]
Fax: [phone]
e-mail: [email protected]
Gammex-RMI GMBH
Bergstrasse 2
35398 Giessen
Germany
[phone]
Fax: [phone]
e-mail: [email protected]