A qualified medical physicist should perform these tests. Alternatively, the tests may be performed by properly trained individuals, such as a nuclear medicine technologist, who has been authorized by a supervising medical physicist. The test results must be reviewed by the qualified medical physicist and properly documented. Note that some specifications that follow come from IAEA Human Health Series 6. 3.3.2 Parameter Actor Requirement Uniformity of response to a uniform flux of radiation from an 123 point source shall be measured intrinsically every quarter. On Planar Uniformity Imaging Site a daily basis planar uniformity with collimators used for I-123 imaging shall be performed using a Tc-99m or Co-57 flood source.. Tests the resolution of the system in terms of the FWHM of its point spread function. Test shall be conducted semiannually with System Spatial Physicist the collimators routinely used with 123I ioflupane studies. The Resolution result of the test shall be less than 8 mm at 10 cm measured using a Tc-99m source. Tests the COR offset, alignment of camera Y-axis, and head tilt with respect to the scanner center of rotation. Mean value of the Verification of COR offset should not exceed1/2 pixel (typically 2 mm) when Physicist measured at the center and edges of the FOV. Position of Y=0 axis Rotation (COR) and the Y gain shall be the same for all heads in a multi-head system. The accuracy of the photon energy analyzer shall be within Photon Energy Physicist manufacturer specifications. Verifying this is typically part of daily Analyzer QC. Shall confirm that the attenuation maps are registered to the CT Attenuation SPECT images within the manufacturer specifications. This is Medical physicist map registration typically performed using manufacturer-provided phantoms and procedures. 3.4. Subject Selection This activity describes criteria and procedures related to the selection of appropriate imaging subjects that are necessary to reliably meet the Profile Claim. 3.4.1 The study is contraindicated in patients with allergies or hypersensitivity reactions to ioflupane, the excipients in the formulation, or iodine, as about 120 mg of Iodine in the form of potassium iodide should be administered by mouth 0.5-to-2 hours prior to the intravenous administration of the 123I
A qualified medical physicist should perform these tests. Alternatively, the tests may be performed by properly trained individuals, such as a nuclear medicine technologist, who has been authorized by a supervising medical physicist. The test results must be reviewed by the qualified medical physicist and properly documented. Note that some specifications that follow come from IAEA Human Health Series 6. 3.3.2 Parameter Actor Requirement Planar Uniformity Imaging Site Uniformity of response to a uniform flux of radiation from an point source shall be measured intrinsically every quarter. On a daily basis planar uniformity with collimators used for I-123 imaging shall be performed using a Tc-99m or Co-57 flood source.. System Spatial Resolution Physicist Tests the resolution of the system in terms of the FWHM of its point spread function. Test shall be conducted semiannually with the collimators routinely used with 123I ioflupane studies. The result of the test shall be less than 8 mm at 10 cm measured using a Tc-99m source. Verification of (COR) Physicist Tests the COR offset, alignment of camera Y-axis, and head tilt with respect to the scanner center of rotation. Mean value of the COR offset should not exceed1/2 pixel (typically 2 mm) when measured at the center and edges of the FOV. Position of Y=0 axis and the Y gain shall be the same for all heads in a multi-head system. Photon Energy Analyzer Physicist The accuracy of the photon energy analyzer shall be within manufacturer specifications. Verifying this is typically part of daily QC. CT Attenuation map registration Medical physicist Shall confirm that the attenuation maps are registered to the SPECT images within the manufacturer specifications. This is typically performed using manufacturer-provided phantoms and procedures. 3.4. Subject Selection This activity describes criteria and procedures related to the selection of appropriate imaging subjects that are necessary to reliably meet the Profile Claim. 3.4.1 The study is contraindicated in patients with allergies or hypersensitivity reactions to ioflupane, the excipients in the formulation, or iodine, as about 120 mg of Iodine in the form of potassium iodide should be administered by mouth 0.5-to-2 hours prior to the intravenous administration of the 123I Rotation 123
001.QIBA_SPECT_Ioflupane_Profile.v1.0_post-public_comments.clean_copy.2017_06_26.docx