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        Precision Resolution Grey Scale Phantom User Guide
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1.  copy with the image on the scanner        11    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     Slide the cover to the Return the handle to Slide the handle down   top of the water dam  the top of the phantom  secure with screws     f  gt        4 Store in an airtight container or plastic bag     11    Target Specifications    Cystic Targets    ETT    EN NN NO 2 4  and 6 mm  S ienn  EE 3  8  and 14cm deep  OT SN EE 1540 10 m s  Attenuation COGTICIONE ciccicscciescsnsietaacccnonessennenstiensanesnceustonssnentanansesannaale 0 05 0 01 dB cm MHz    Grey Scale Targets    Eloge 9 5 x 9 5 x 13 4 mm  Placement E E EN ET NE MG 4 cm deep  Speed Ol SUNN eenegen eege eege eege 1540 10 m s  Temperature dependence on speed Of sound    1 5 m s   C  Contrast   R low scatter   6 dB   6 dB  high scatter relative to background    Pin Targets    ET 0 1 mm  Vertical Spacing    sese sere eee neee eee 2 cm at 2 16 cm deep  ee ZONM Al SAC UG E 3 cm at 2 and 12 cm deep  Cross Ders    eee 0 2 mm at 2 and 6 cm deep    Resolution Target Group  seit tod E A at 3  8  and 14 cm deep    All acoustic measurements made at 4 5 MHz  22  C     Due to our philosophy of continuous quality improvement   all specifications are subject to change     12    Dead Zone   target group      a i EE 0 1 mm Nylon Pins     3 cm spacing    r    Par vidde  cyst  
2.  the circle     19    3  Measure and record the echo level of each target    4  Measure and record the echo level of the background material directly beside  the anechoic target  Use as close to the same ROI as the target as possible   Unfreeze the image     5  Perform this process three times and record the average echo level for each grey  scale target and for the background material on the data sheet     Analysis    Contact your service engineer if target 2  3  or 4 varies from the baseline by 10  or  more     20    Qualitative Measurement    Video monitors on most ultrasound systems contain a    grey bar    which shows the grey  levels available for display  Grey bars normally contain between sixteen and sixty four  steps of increasing brightness  Pixel values can be estimated by locating a grey bar step  that approximates the brightness of the region of interest     Note  It is absolutely critical that all system control settings be precisely reproduced for  these tests  Errors will introduce variations in your data and potentially invalidate your  results     Method    Assign a step on the grey bar to each grey scale target and the background     Procedure   1  Assign a unique number to each grey level on the grey bar    2  Scan the grey scale targets and display them as large as possible  Freeze the  image    3  For each target  determine which step on the grey bar is the same brightness as    the target and record this number on the data sheet  Do the same for the bac
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5. 405 GSX LE  Precision Resolution  Grey Scale Phantom          User s Guide    Table of Contents    Fa 970 TT og EE 3  Caring for your E  4  Scanning your 405 GSX LE ttt netnnenntennnnn nerne nnee ne 5  A Guided Tour of your E  6  Evaluating AE e EE 7  Target SPC ANS TT T 12  Ee 12  Grey Scale el EE ENE ENE ENE 12  PM MM settee EE 12  Resolution Target Group    12  Phantom SPENNE ASer 14  VE GL er  8    e de 9 srecne enrenar er ere Serr renee aera ee en me tert rte een 14  Tissue Mimicking Background Maternal    sees eee 14  Harmonic IMAJIN Gaiaa aa aa a E A a 15  Grey ee e TEE 16  System Dae  17  Quantitative MESEN ee 19  Baseline EE ERE 19  Ise  ERE EE EEE een 19  GM EEE ET EE EE RE 21  eT ISIC CAN EE EE 22  Charts andi Graph TT 22  Product E E 23  Sales  and Te EE EE 24    Introduction    The 405 GSX LE phantom provides users with a wide range of criteria to evaluate  the performance of their ultrasound machine  The advanced tissue mimicking gel  used in the phantom has been developed to provide a smoother background texture  than conventional gels  The gel reduces backscatter and is fully compatible with the  latest tissue harmonics equipment and technology  The phantom utilizes an advance  composite film scanning surface that improves transmission properties  thus allowing  more of the ultrasound beam to be received and transmitted     The 405 GSX LE phantom is designed to be used for quality control purposes when  monitoring these important image characteristics     axia
6. KM           Horizontal  cross strings    D B    a    La  2 4  and B mm  10 flow scatter cysts       0 1 mm Nylon Pins  3 cm spacing       1 mm 3 mm   Pr     2 0 mm   3 mm    171 0 mm  1 03 mm  0 25 mm  Resolution target group Dead Zone target group    13    Phantom Specifications    Physical Specifications    VE Approx  2 8 kg  6 Ibs  5 oz    DIMENSIONS EE EE NE ER 23 2 x 8 25 x 18 5 cm   mee  9 25x3 25x7 25in    Scanning 510 le EE EEE Composite Film  GE ene eebe tegen Extruded ABS plastic  KSE ee ee Nylon monofilament    Tissue Mimicking Background Material    Water based gel with appearance of human tissue     eiee fo  516  Vg 0 BEE 1540 10m s  Aten  ation ee ENE Aa 0 7 0 05 dB cm MHz  EN ER EE 0 5 0 05 dB cm MHz  EE NE EE EE refer to phantom side label  Nonlinearity parameter EE 6 60 3  S 6 7  Accepted value for human liver tissue     All acoustic measurements made at 4 5 MHz  22  C     Due to our philosophy of continuous quality improvement   all specifications are subject to change     14    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 fre   quency  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 thr
7. RODUCTS OR PARTS THEREOF     THEREARE NOEXPRESS ORIMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRAN   TIES SET FORTHABOVE  SELLER MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS  FORAPARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS ORANY PARTS THEREOF        2003  2013 GAMMEX 006469 00 06    Your warranty may be registered at http  Awww gammex com warranty asp    23    Sales and Service    GAMME 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  sales gammex com    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  support gammex com    GAMMEX  Inc   7600 Discovery Drive  Middleton  WI 53562 U S A     http   www gammex com    24    Notes     25       aNNosvYLTIN ES    ISO 13485    Certified Quality System    Gammex  Inc    7600 Discovery Dr    Middleton  WI 53562 USA  1800 GAMMEX 1  426 6391   1 608 828 7000   Fax  1 608 828 7500  www gammex com   e mail  sales  gammex com    Gammex RMI LTD  Broadway Business Centre  32A Stoney Street  Nottingham NG1 ILL   United Kingdom    44 0115 9247188   Fax   44 0115 9247189  e mail  uksales  amp  gammex com    Gammex RMI GMBH  Bergstrasse 2   35398 Giessen   Germany    49 64
8. an alternate test can be performed     Pin targets  have merged       9 9    s  Lateral resolution of this scan is 0 5mm  PSI PS Es  C NOT o    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 demon   strates the width of the ultrasound beam at that depth and approximates the  lateral resolution of the scanner     Measure pin width  to get lateral Pay  resolution     Pin targets are  narrowest in the  focal zone        Decrease the image depth and examine the axial resolution target group at 3 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        These r   targets   overlap   vertically  Ia mm  Lower pin  targets have      1 0 mm  merged  Ing Smi   0 25 mm       Axial resolution of this scan is 1 0 mm        Unresolved Resolved    Pin targets 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     Examine the other axial resolution target groups and compare the resolution at  various depths  Axial resolution may change with depth     Scan the nearest cystic target group  Eac
9. ay to familiarize yourself with the features and functions of the  405 GSX LE  A guided tour is provided on the following pages     Water dam with Dead zone  protective cover target group    Horizontal pins for  horizontal distance  accuracy test    Grey scale targets  and one anechoic  target    Low scatter  targets for cyst  imaging test    Horizontal pins for  horizontal distance  accuracy test    Resolution  target group       Vertical pins for vertical Depth indicators  distance accuracy and in centimeters  lateral resolution tests    Evaluating the Phantom    Remember  e phantom comes ready to scan  Do not peel off surface mate   rial   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        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 de
10. difference in bright   ness between different echo levels  will remain constant  If the shape of the S curve  changes  the relative image brightness for each echo level will also change     For example  image post processing techniques help the user identify subtle tissue vari   ations by modifying the shape of the S curve to emphasize certain ranges of echo levels   Degradation in the system hardware can also affect the shape of the curve and produce  unexpected variations in the contrast between echo levels  The distortion in the information  displayed to the user may affect the interpretation of the ultrasound image  This is why it is  important to do quality measurement with as little post processing as possible  An example  of these distortions is shown on the following page     17    Monitor  Brightness  Level       XB 0B XB Echo Level    Changes in the shape of the S curve result in different brightness levels for the same  echo levels  Notice how the positions of the original brightness levels B_  Bg and B   have moved to B_   Bo  and B         Changes in the system response can be identified by measuring the average pixel  value of the grey scale targets and the background material as displayed on the video  monitor  Pixel values can be estimated by eye or measured with image analysis tools  provided on some ultrasound instruments or computers equipped with video    frame  grabbers    and special software     18    Quantitative Measurement    A target   s brightness 
11. ee 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 the nonlinearity 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 resolu   tion     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  meani
12. h 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        Normal Distorted System noise    Measure the dimensions of the 6 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     Decrease image depth to the minimum and examine the dead zone target group   The dead zone targets can 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   Not the scanning surface     10  Scan the four grey scale targets and observe the difference in their grey levels   Adjust the gain control and observe how this affects the brightness of the targets   Notice how noise in the anechoic target becomes apparent as the gain increases   If your system has image    post processing    capabilities  observe how the contrast  between targets changes with different settings  Adjust the gain control to the  lowest noise level  This is the point at which you eliminate noise in the anechoic  cyst  lower the gain until it just disappears   Record this gain setting and use it for  future grey scale measurements  Freeze the image and visually evaluate the grey  scale targets  Match each target with a step on the grey bar in the image  Make a  hard copy and compare the hard
13. k   ground material directly beside the anechoic target  Keep a print out of the image  for reference    Analysis    Contact your service engineer if any target varies from the baseline by more than two  steps     21    Phantom Desiccation    Over time  the phantom   s water based gel will slowly lose moisture  This process is  accelerated by high temperatures  incorrect storage  and damage to the case or scan   ning surface  Consistently storing the phantom in an air tight container will contribute  greatly to long phantom life  Properly storing your phantom will reduce the amount of  moisture lost per year  For instructions on how to properly store and take care of your  phantom  go to the Caring for Your Phantom section     For most climate controlled environments  the phantom weight should be checked  every six months  Phantoms used in high temperature low humidity environments or  in mobile situations should be tested more frequently  As the phantom desiccates   the scanning surface may flatten out  It is suggested that the phantom be sent in for  rejuvenation once it has lost 10 15 grams of its original weight  If the phantom has  lost more than 20 grams  Gammex cannot guarantee that the phantom will be able to  rejuvenate successfully     Charts and Graphs    Refer to the Charts and Graphs section of the manual CA to find the appropriate  charts and graphs for your 405 GSX LE phantom  which include     Data Sheet    Quantitative Measurement  Qualitative Measurement    
14. l resolution   lateral resolution   dead zone target imaging   vertical and horizontal distance accuracy  image uniformity    oe Sh    The triangular grey scale targets in the phantom can be used to test the resolution of  high performance ultrasound scanners     Unique to the 405 GSX LE are two horizontal cross fibers located in the middle of the  phantom  These fibers have been included to assist the user in aligning the transducer  and can be used as a reference    marker    to ensure that QA tests are performed  consistently every time     Limitations of Use  The 405 GSX LE is designed to be used to aid in the quality control testing and monitor     ing of high performance ultrasound systems only  It is not to be used to make diagnostic  decisions     Caring for your 405 GSX LE    Phantom comes ready to scan  Do not remove surface material        Store your 405 GSX LE with 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 405 GSX LE at 352 105  F  2   40  2C    Freezing temperatures will damage the phantom and high temperatures will accelerate  desiccation     Weigh your 405 GSX 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 prema
15. level can be most accurately measured using electronic methods   The user defines a region of interest and the scanner determines the average pixel  value  To reduce the effect of soeckle and small variations in the targets  several  measurements are taken and averaged     Note  If your system does not have a region of interest  ROI  tool  you will not be able  to perform this test  As an alternative  refer to the Qualitative Measurement section of  this document  on page 21     Note  All values determined by the quantitative measurement test depend on scanning  technique  Great care should be taken to perform the test in the same manner each  time     Method  Define a region of interest and measure the average echo level     Procedure    Baseline Test    1  Scan the grey scale targets and display them as large as possible  Freeze the  image   2  Measure the echo level of the anechoic target  Adjust the system gain so that the    measurement is approximately 1  This ensures that the system   s noise floor is  barely reaching the visible level     3  Record this setting and reuse for all subsequent tests     Subsequent Tests    Ti Scan the grey scale targets and display them as large as possible  Adjust the  system control settings as recorded on the data sheet     2  Freeze the image and place the region of interest  ROI  tool completely inside    the grey scale target image  The ROI should be approximately 2 3     3 4 the  diameter of the circle  and it should be centered in
16. ng B A is between 6 and 7       Gong  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     15    Grey Scale Applications    Metastases are sometimes slightly hyperechoic or hypoechoic compared with the sur   rounding tissue  If the scanner is not measuring grey levels accurately  the metastases  may not be detected  The Quantitative Measurement ensures that the grey level signal  is measured consistently  The Qualitative Measurement ensures that grey levels are  displayed on the monitor consistently  By performing these tests  the user can determine  the optimal system settings for measuring grey levels  which can then be used in clinical  applications     16    System Linearity    Ultrasound systems use special processing circuits to translate the amplitude of echoes  into brightness levels on the video monitor  These circuits use mathematical functions  that often produce an S shaped curve when graphed  As shown in the figure below   each echo level produces a corresponding brightness level on the monitor     Monitor  Brightness  Level By       XB OB XB Echo Level    An S shaped curve is used to translate echo levels into brightness levels on the video  display  Notice how each echo level     X  0 and  X dB produce the corresponding bright   ness values B_  By and B      As long as the shape of the curve remains constant  the contrast  or 
17. nty 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 examination  Buyer shall pay all transportation charges  Products manufac   tured by third parties must be returned to Seller within thirty  30  days of Seller   s invoice date for such  Products  Products ordered by Buyer to be manufactured by Seller on a special order basis may be  returned under Seller   s warranty policy for repair or replacement but may not be returned for credit     SELLER SHALL NOT BE OTHERWISE LIABLE FOR ANY DAMAGES INCLUDING BUT  NOT LIMITED TO INCIDENTAL DAMAGES  CONSEQUENTIAL DAMAGES  OR SPECIAL  DAMAGES OR FOR ANY OTHER LOSS  DAMAGE PENALTY OR EXPENSE OF ANY KIND   INCLUDING  WITHOUT LIMITATION  LOSS OF PROFITS OR OVERHEAD REIMBURSE   MENT  PERSONAL INJURY OR PROPERTY DAMAGE  THE AFORESAID WARRANTY  OBLIGATION OF SELLER CONSTITUTES ITS SOLE LIABILITY  AND  UNDER NO CIR   CUMSTANCES  SHALL THE MAXIMUM LIABILITY OF SELLER UNDER ANY LEGAL  THEORY  e g  CONTRACT  WARRANTY  NEGLIGENCE  PROMISSORY ESTOPPEL   STRICT LIABILITY  MISREPRESENTATION  TORT  AND FOR ANY REASON WHATSO   EVER  e g  DEFECT  DELAY OR OTHERWISE  EXCEED THE PURCHASE PRICE OF THE  DEFECTIVE PART  REGARDLESS WHETHER THE CLAIM IS ASSERTED BY BUYER OR  ANY OTHER PERSON OR ENTITY  THE LIABILITIES OF SELLER  AS ABOVE SET FORTH   SHALL NOT BE EXTENDED BECAUSE OF ADVICE GIVEN BY IT IN CONNECTION WITH  THE DESIGN  INSTALLATION OR USE OF THE P
18. pth markers on the phantom label will help you determine  the depths of the targets     0 1mm Nylon Pins    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     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 2 cm spacing while the horizon   tal pins have 3 cm spacing     Use these 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     Use the calipers  to measure  vertical distance  accuracy    and horizontal  distance accuracy       Freeze an image of the resolution target group at 1 cm  Examine the horizontal  row of pins at the top of the target group  The pins that are closest together  without touching indicates the scanner   s lateral resolution     Repeat this procedure with the other resolution target groups  Notice how lateral  resolution is narrowest in the focal zone  For a transducer whose focal zone is in  the area between the resolution targets  
19. ture desiccation     Gammex recommends annual servicing of your 405 GSX LE to ensure proper  operation  Our qualified service technicians will check for desiccation and provide any  needed rejuvenation  scanning certification to original specifications  and repairs     Scanning your 405 GSX 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     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  transmission is a result of insufficient coupling     Do not press the transducer into the scanning surface  This damages the  scanning surface and will shorten the life of the phantom  For curved transduc   ers  use water or a thick gel layer     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     A Guided Tour of your 405 GSX LE    The Precision Resolution Grey Scale Phantom  405 GSX LE  provides a means for  monitoring the image quality of ultrasound scanning systems  The tissue mimicking  gel in the 405 GSX LE is ultrasonically similar to human tissue  This allows the use of  normal scanner control settings and ensures that the performance measured  closely  approximates the scanner   s performance in a clinical examination     Scanning is the best w
    
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