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decimal3d:instructions_for_use:instructions_for_use [2019/09/13 01:38] – [Known Limitations] kerhartdecimal3d:instructions_for_use:instructions_for_use [2019/11/29 13:03] – [Clinical Safety] kerhart
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 ===== Overview, Indications for Use, and Intended Use ===== ===== Overview, Indications for Use, and Intended Use =====
  
-The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiotherapy devices through the use of optical (laser) scanning technology. This device will serve as a direct replacement to the current processes for designing such patient-specific radiotherapy devices. One such common current process is for electron therapy clinical setups, which involves hand drawing of the patient-specific aperture shape onto a semi-transparent “template” block, using the treatment light field to verify accuracy against the treatment area that has been outlined directly on a patient by the treating physician. This now flattened and projected aperture shape can then be scanned and digitized allowing for computer controlled fabrication. This new decimal3D device will replace this process by providing a means to accurately scan and digitize the treatment area.  After the surface scan is obtained, this device also provides a means for designing and ordering the required devices (e.g. digitization of the field for electron apertures), analogous to the current digitization process in the existing clinical workflow.+The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a “clinical patient set up” is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology). One such common current process is for electron therapy clinical setups, which involves hand drawing of the patient-specific aperture shape onto a semi-transparent “template” block, using the treatment light field to verify accuracy against the treatment area that has been outlined directly on a patient by the treating physician. This now flattened and projected aperture shape can then be scanned and digitized allowing for computer controlled fabrication. This new decimal3D device will replace this process by providing a means to accurately scan and digitize the treatment area.  After the surface scan is obtained, this device also provides a means for designing and ordering the required devices (e.g. digitization of the field for electron apertures), analogous to the current digitization process in the existing clinical workflow.
  
 This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified Radiation Oncologist has made appropriate determination of the acceptability of a “clinical set up” approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific device from our company, in cases where a licensed Radiation Oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device’s indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient. This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified Radiation Oncologist has made appropriate determination of the acceptability of a “clinical set up” approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific device from our company, in cases where a licensed Radiation Oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device’s indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient.
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 ===== Clinical Safety ===== ===== Clinical Safety =====
  
-It is the responsibility that the user performs end-to-end testing prior to the clinical use of decimal3D. The user should follow accepted industry guideline and clinical experience for the end-to-end testing. This testing should be performed by qualified personnel and should ensure (at a minimum) that users are able to scan, digitize, and order an electron block that meets or exceeds the clinical accuracy as compared to the clinic's current process for clinical electron set ups.+It is the responsibility of the user to perform end-to-end testing prior to the clinical use of decimal3D. The user should follow accepted industry guideline and clinical experience for the end-to-end testing. This testing should be performed by qualified personnel and should ensure (at a minimum) that users are able to scan, digitize, and order an electron block that meets or exceeds the clinical accuracy as compared to the clinic's current process for clinical electron set ups.
  
 It is the responsibility of the facility to ensure that all users of the decimal3D have had training on the decimal3D App and possess the appropriate clinical education and experience to properly use the application. It is the responsibility of the facility to ensure that all users of the decimal3D have had training on the decimal3D App and possess the appropriate clinical education and experience to properly use the application.
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   - Once a scan has been created its name cannot be edited (scan names are for convenience only and are used elsewhere in the application)   - Once a scan has been created its name cannot be edited (scan names are for convenience only and are used elsewhere in the application)
   - Once a beam has been created its name cannot be edited (beam names are used within the cutout engraving, therefore if an appropriate name was used, we recommend that you create a new beam with the desired name, using the same parameters, and then delete the wrongly named beam)   - Once a beam has been created its name cannot be edited (beam names are used within the cutout engraving, therefore if an appropriate name was used, we recommend that you create a new beam with the desired name, using the same parameters, and then delete the wrongly named beam)
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 ===== Release Notes ===== ===== Release Notes =====
  
decimal3d/instructions_for_use/instructions_for_use.txt · Last modified: 2023/04/17 16:34 by kerhart