Multi-Purpose, Multi-Tissue Ultrasound Phantom LT QU AL RASOUN D USER GUIDE ITY NC ASSURA E U Model 040GSE 900 Asbury Ave • Norfolk, Virginia 23513 • USA • Tel: 757-855-2765 • WWW.CIRSINC.
TABLE OF CONTENTS 1 OVERVIEW 1 2 INSTRUCTIONS FOR USE 2 HANDLING AND CARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 USE OF REMOVABLE WATER WELL AND COVERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 GENERAL GUIDELINES FOR PERFORMING MEASUREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . 4 ESTABLISHING A BASELINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OVERVIEW The Model 040GSE Multi-Purpose, Multi-Tissue Ultrasound Phantom is a sturdy, reliable phantom for testing the imaging performance of ultrasonic systems. Key Tests with Model 040GSE The phantom is made of CIRS' proprietary Zerdine® hydrogel polymer, which has been formulated to provide tissue mimicking properties under B-mode ultrasound and other features such as harmonic imaging.
INSTRUCTIONS FOR USE HANDLING AND CARE With proper care, the Model 040GSE 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.
HANDLING AND CARE (CONTINUED) Regulations regarding disposal of materials with trace acrylamide monomer vary by locality. Contact your local authority for instructions. If assistance is desired in the proper disposal of this product, including accessories and components, after its useful life, please return to CIRS. USE OF THE REMOVABLE WATER WELL AND COVERS The phantom is shipped with the protective cover attached to the phantom.
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 that 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 machine or to compare different machines in a quantitative manner.
2. Baseline measurements: The first set of measurements taken will be the baseline measurements for the combination of system settings and phantom. Record the system settings and phantom serial number used to acquire each measurement along with your measurement results. On subsequent scans, refer to the baseline results to determine if the ultrasound system has drifted to an unacceptable level.
3. Adjust the instrument settings (gain, TGC, output, etc.) as for a “normal” technique. Record these settings for use on subsequent testing. 4. Align the probe so that the targets are maximized. 5. Freeze the image and obtain a hard copy. 6. Observe the general appearance of the phantom. Note if all regions at the same depth are displayed with the same intensity across the image. 7. Record your observations.
BEAM PROFILE, FOCAL ZONE AND LATERAL RESPONSE WIDTH The beam profile is the shape of the ultrasound beam. A typical beam profile is shown in Figure 1. The narrowest region within the beam profile is indicative of the focal point. By convention, the region surrounding the focal point with intensity within 3 dB of maximum is the focal zone. The best images are obtained while within the focal zone.
4. Align the probe so that all the vertical targets are displayed at their maximum intensity level. 5. Freeze the image and obtain a hard copy. 6. Using electronic calipers, measure the distances between two wires at various depths or align the echoes to the display markers for comparison. 7. Record these measurements. 8. Compare the measured values with the recorded baseline distances.
AXIAL AND LATERAL RESOLUTION TESTING (CONTINUED) The Model 040GSE has three combined axial and lateral resolution target groups. The first two groups, at depths of 3 cm and 6.5 cm, are designed for probes of 5 MHz and above. They consist of 13 parallel nylon wires of 80 microns diameter. The third target is located at 10.5 cm depth for evaluation of low frequency probes. It consists of 11 parallel nylon wires of 80 microns diameter.
D5 Axial Resolution D4 D3 D2 Edge to adjacent Edge 3 mm C6 C5 C4 Edge to adjacent Edge 2 mm C3 D1 C1 C2 Lateral Resolution Figure 3 - Combined Axial/Lateral Resolution Target at 10.5 cm depth (top) and a table listing the distances between them (bottom) Targets Axial Resolution (mm) C1-D1 C2-D2 1.0 2.0 C3-D3 3.0 C4-D4 4.0 C5-D5 5.0 Targets Lateral Resolution (mm) C1-C2 C2-C3 C3-C4 5.0 4.0 3.0 C4-C5 2.0 C5-C6 1.
In the second method, the anechoic cylinders are used as simulated focal lesions as follows: 1. Apply coupling gel to the scanning surface or fill the water trough with tap water. 2. Adjust the instrument settings (gain, TGC, output, etc.) as for a “normal” technique. Record these settings for use on subsequent testing. 3. Orient the transducer to image the length the anechoic cylinder, taking care to adjust the tilt so that the cylinders are lined up in a vertical column. 4.
Testing for low-contrast target detectability is performed as follows: 1. Apply coupling gel to the scanning surface or fill the water trough with tap water. 2. Position the transducer above the cyst of interest and perpendicular to the wires. You should be imaging the circular cross section of the cylinders. 3. Adjust the instrument settings (gain, TGC, output, etc.) as for a “normal” liver technique. Record these settings for use on subsequent testing. 4.
ELASTICITY CONTRAST SENSITIVITY The Model 040GSE provides elasticity targets for the next generation of ultrasound imagers using elastography. The elasticity value for the background is 20 kPa. The target group at a depth of 1.5 cm has a diameter of 6mm, while the target group at 5 cm has a diameter of 8 mm. Both groups provide elasticity values of 10, 50 and 100 kPa. These targets are suitable for qualitative assessment of sonoelastography systems, and checking system performance over time.
DEAD ZONE ASSESSMENT CONTINUED The near field group consists of parallel, 100 micron diameter, nylon, monofilament wires horizontally spaced 6 mm apart from center to center (Figure 4, page 13). Vertical distance from the center of each wire to the top edge of the scanning surface ranges from 5 mm down to 1 mm in 1 mm increments. 6mm 6mm 6mm 1mm 6mm SCANNING 2mm 3mm 4mm 5mm Figure 4 - Near Field Target The depth of the dead zone may be measured as follows: 1.
SPECIFICATIONS TARGET LAYOUT PHANTOM Housing Outer Dimensions Scanning Surface Scanning Material Speed of Sound Other ABS Plastic 17.8 x 12.7 x 20.
WIRE TARGETS Material Nylon monofilament NEAR FIELD GROUP Number of targets Diameter Depth range Vertical distance between targets 5 100 microns 1 to 5 mm 1 mm VERTICAL DISTANCE GROUP Number of targets Diameter Depth range Vertical distance between targets 16 100 microns 1 to 16 cm 10 mm HORIZONTAL DISTANCE GROUPS Number of groups Diameter Depths Number of targets Horizontal distance between targets 2 100 microns 4 & 9 cm 6 & 7 respectively 10 & 20 mm respectively AXIAL / LATERAL RESOLUTION GROUPS G
ANECHOIC STEPPED CYLINDERS Material Zerdine LEGEND: Depth (cm) Diameter (mm) 1.3 2.0 3.0 4.5 6.7 10.0 1.5 X X X X X - 4.5 X X X X X - 7 - X X X X X 10 - X X X X X 13 - X X X X X 16 - X X X X X X = Apply - = Do Not Apply Table 1 - Cystic Masses Location and Size GRAY SCALE TARGETS Material Zerdine Depth & Diameter Contrast, dB -9 -6 -3 +3 +6 >15 3 cm, Ø 8mm X X X X X X 11.
ZERDINE® The Model 040GSE is constructed from a patented, solid elastic material developed at CIRS called Zerdine. Phantoms constructed from Zerdine will not melt or leak when punctured and they do not require refrigeration. Zerdine is also more elastic than other materials and allows more pressure to be applied to the scanning surface without subsequent damage to the material. At normal room temperatures, Zerdine will accurately simulate the ultrasound characteristics found in human liver tissue.
WARRANTY All standard CIRS products and accessories are warranted by CIRS against defects in material and workmanship for a period as specified 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 manufacturer. Products repaired in warranty will be returned transportation prepaid.
APPENDIX 1: QUALITY ASSURANCE RECORD FOR MODEL 040GSE MODEL 040GSE MULTI-PURPOSE MULTI-TISSUE ULTRASOUND PHANTOM QUALITY ASSURANCE RECORD Q Location: ____________________ Unit: ________________ Probe: ________________ QC Phantom SN: ______________________ Machine Settings: Depth of Field (FOV) ________________________ cm Gain: _______________________ Power: ______________________ Focal Zone(s) ______________ cm ____________ cm ____________ cm __________ cm _________cm Preprocessing__________________ Post
COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC. 900 Asbury Ave Norfolk, Virginia 23513 • USA TOLL FREE 800.617.1177 TEL: 757.855.2765 FAX: 757.857.0523 EMAIL: admin@cirsinc.com www.cirsinc.com Technical Assistance 1.800.617.1177 © 2013ComputerizedImagingReferenceSystems,Inc.Allrightsreserved. Specifications subject to change without notice. Publication: 040GSE UG 102620 ComputerizedImagingReferenceSystems,Inc.hasbeen certified by UL DQS Inc. to (ISO) 13485:2016. Certificate Registration No.10000905-MP2016.
