Page 3
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.
INSTRUCTIONS FOR USE HANDLING AND CARE For best results the phantom should be kept clean at all times and stored at room temperature. In particular a build-up of dried coupling gel on the scan surface should be avoided. The phantom may be cleaned with warm water using a lint free cloth.
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 ATS570. It may be useful to refer to the target map, shown in the Specifica- tions section of page 15, 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.
5. Document the depth measurement on the quality assurance record. Results: The system's depth of penetration should remain consistent from week to week when using the same instrument settings and Model 570 phantom. Compare the test results obtained from the baseline records. If the current image demonstrates changes in the system's ability to resolve these targets, corrective action should be considered.
VERTICAL DISTANCE MEASUREMENTS Vertical distance measurements are obtained along the axis of the sound beam. Ac- curate 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.
Document all of the measurements on the quality assurance record. Note: Some sector scanners have distance markers on the outside edges of the sector image with no other indicators available. Hand-held calipers must be used for distance measurements within the image on the monitor. Results: The system's horizontal distance measurements should remain consistent from week to week when using the same instrument settings and Model 570 phantom.
GRAYSCALE CONTRAST SENSITIVITY Gray scale or gray scale processing uses the amplitude of the echoes received to vary the degree of brightness of the displayed image. The adjustment of the echo signal required to go from a just noticeable (lowest gray scale level) echo to the maximum echo brightness is referred to as the displayed dynamic range.
Page 11
Using the electronic calipers, measure the distance between the first tar get imaged and the echo produced by the scan surface. The resulting value will be the depth of the dead zone Document the depth measurement on the quality assurance record. Results: The system's dead zone should remain consistent from week to week when using the same instrument settings and Model 570 phantom.
SPECIFICATIONS TARGET LAYOUT PHANTOM Housing Outer Dimensions 27 x 21.5 x 9.6cm Scanning Surface 17.5x7.5 cm 14.0 x7.5 cm Scanning Material Urethane Rubber Speed of Sound 1450 m/s at 23° WIRE TARGETS Material Nylon monofilament Diameter 0.12mm ENDOCAVITY Opening: Ø 26.9mm x 71mm deep Slots: 12.7 mm;...
Page 13
VERTICAL DISTANCE GROUP Number of targets: B1: 17 B2: 8 Depth range: B1: 10-160 mm B2: 10-80 mm Spacing: B1: 10 mm B2: 10 mm HORIZONTAL DISTANCE GROUP Number of groups: Depths: 5 & 5 cm Number of Targets: Spacing: 2 cm DEAD ZONE GROUP Number of targets:...
Page 14
+3, -3 dB Diameter: 6 mm Distance from Endocavity Opening: 30 mm NOTES All dimensions without tolerances are nominal All measurements made at 22˚C ± 1˚C MODEL ATS570 INCLUDES COMPONENT DESCRIPTION Multi-Purpose & Endoscopic Phantom 5-Year Warranty User Guide Certificate of Compliance...
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.
Page 16
APPENDIX 1: QUALITY ASSURANCE RECORD FOR MODEL ATS570 MODEL ATS570 MULTI-PURPOSE & ENDOSCOPIC PHANTOM QUALITY ASSURANCE RECORD...
Need help?
Do you have a question about the ATS570 and is the answer not in the manual?
Questions and answers