10 years. CIRS is certified to ISO 13485:2016 standards. We have an in-house test facility to measure acoustic properties of materials. In addition, ultrasound imaging systems are used to inspect each phantom. Every ultrasound phantom that CIRS distributes has passed thorough testing during manufacture and completion to ensure the highest quality product available.
GENERAL GUIDELINES FOR PERFORMING MEASUREMENTS To evaluate the performance of diagnostic ultrasound imaging systems, the Model ATS539 has a combination of monofilament line targets and tissue-mimicking cylin- drical targets of varying sizes and contrasts. The following are general steps for imaging all targets: •...
If not, then the conclusions drawn may not be valid. CIRS recommends that you use the most commonly used settings for the type of probe tested- i.e. the liver preset values for an abdominal probe- which are called a "normal"...
TESTING PROCEDURES The following sections outline procedures for routine quality control tests with the Model ATS539. It may be useful to refer to the target map, shown in the Specifica- tions section of page 14, when reviewing these procedures. UNIFORMITY TESTING Uniformity is defined as the ability of the machine to display echoes of the same magnitude and depth with equal brightness on the display.
Note: In addition to the above, this test should also be performed with output levels set at the highest and lowest settings. This enables any changes in output to be more easily detected. 4. Position the transducer over the 8 mm group of anechoic targets. 5.
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Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal" scanning. If the bottom of the phantom is seen, adjust the gain settings until image goes entirely black. Record these settings on the quality assurance record. These settings should be used for subsequent testing.
VERTICAL DISTANCE MEASUREMENTS Vertical distance measurements obtained along the axis of the sound beam. The accurate representation of the size, depth and volume of a structure is a critical factor in a proper diagnosis. Most imaging systems use depth markers and/or electronic calipers to obtain these measurements.
Testing is performed as follows: Note: The Model ATS539 Multipurpose phantom provides two scanning surfaces used to evaluate horizontal measurement calibration. Linear array scanning sys- tems should use #1 scanning surfaces. Sector scanning systems should use #3 scanning surfaces.
Lateral Resolution is dependent upon the beam width, increased beam width will reduce the Lateral Resolution. The Model ATS539 provides four scanning surfaces to evaluate axial-lateral resolu- tion at four given depths. Target locations in the phantom are referenced from the center of the array at target point 5.
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The system's ability to resolve the array targets at all four depths should remain consistent from week to week when using the same instrument settings and the Model ATS539 phantom. Compare the test results obtained with a baseline or previous test. If the current image demonstrates changes in the system's ability to resolve these targets, corrective action should be considered.
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Adjust the instrument settings (gain, TGC, output, etc.) as for a “normal” tech- nique. Record these settings for use on subsequent testing Orient the transducer to image the length of the vertical target wires, taking care to adjust the tilt so that the wires are lined up in a vertical column. Rotate the transducer 45°...
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Results: This target group varies in echogenicity and provides a good indication of the performance of the gray scale processing and displayed dynamic range. The test should be compared with a baseline test using the same instrument settings, to determine if any change in the characteristics of the target group has occurred with time.
Freeze the image and obtain a hard copy. Examine the image to determine the first and last target in each size group displayed. Record the range of depths visualized for each group. Due to the configuration of the sound beam small targets in the near field may not be imaged.
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Apply an adequate amount of low viscosity gel or water to the scan surface. If water is used, fill the scanning well slowly to avoid introduction of air bubbles. Adjust the instrument settings (TGC, output, etc.) to establish baseline values for "normal" scanning. If the bottom of the phantom is visualized, adjust the gain settings until the image goes entirely black.
SPECIFICATIONS TARGET LAYOUT Trim this edge only before applying. Align edge to top edge of Phantom. PRODUCT LABEL SPECIFICATIONS ATS 539 Multi-Purpose Phantom NAME: SCALE: 24.7 cm x 22.5 cm RTPC_Target LBL 539_102620 FILE: 900 Asbury Ave SIZE: Norfolk, Virginia 27613 800-617-1177 / 757-855-2765 102620 TRIM TO CROP MARKS...
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NEAR FIELD GROUP Number of targets: Depth range: 2.0 - 10.0 mm Spacing: 1.0 mm VERTICAL DISTANCE GROUP Number of targets: Depth range: 1.0 - 18.0 cm Spacing: 1.0 cm HORIZONTAL DISTANCE: LINEAR PROBES Number of targets: Depth from Scan Surface #1: 5.0 cm Spacing: 2.0 cm...
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Depth: 4.0 cm Contrast: +15,+6, +3,-3,-6, -15 dB with respect to background NOTES All dimensions without tolerances are nominal All measurements made at 22˚C ± 1˚C MODEL ATS539 INCLUDES COMPONENT DESCRIPTION Multi-Purpose Phantom 10-Year Warranty User Guide Certificate of Compliance...
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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.
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APPENDIX 1: QUALITY ASSURANCE RECORD FOR MODEL ATS539 MODEL ATS539 MULTI-PURPOSE ULTRASOUND PHANTOM QUALITY ASSURANCE RECORD...
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