decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/10/16 17:44] – kmobile | decimal3d:instructions_for_use:instructions_for_use [2019/11/29 13:05] – [System Availability and Data Integrity] 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 | + | The primary purpose and intended use of this device is to improve the efficiency of designing patient specific |
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 | + | It is the responsibility |
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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===== Product Features ===== | ===== Product Features ===== | ||
- | decimal3D is a medical software accessed on an iPad and managed through the Apple App Store®. decimal3D allows users to enter standard patient information, | + | decimal3D is a medical software accessed on an iPad and managed through the Apple App Store®. decimal3D allows users to enter standard patient information, |
==== System Availability and Data Integrity ==== | ==== System Availability and Data Integrity ==== | ||
- | The decimal3D App is installed on a standard Apple iPad and uses the Structure Sensor by Occipital. These off-the-shelf hardware components are covered by manufacture warranties, which can be extended to ensure continuous support and service for all components of the decimal3D system. All system data is stored locally on the iPad using secure encryption technology. As this application stores patient protected health information (PHI), clinics should secure the iPad following their internal Mobile Device protection policies to ensure protection of patient data and maintain HIPAA compliance. Remote tracking and lockout software is highly recommended to ensure the iPad data can be locked, deleted, and recovered in the event an iPad is lost or stolen. | + | The decimal3D App is installed on a standard Apple iPad and uses the Structure Sensor |
It should be noted however, that decimal3D nor its host iPad should be used as the sole location to store critical patient treatment record information. As a mobile device, iPads can be prone to potential loss or damage. Once an order has been placed however, .decimal securely stores the treatment device information on its servers for the time period required by the US FDA and users may request this information, | It should be noted however, that decimal3D nor its host iPad should be used as the sole location to store critical patient treatment record information. As a mobile device, iPads can be prone to potential loss or damage. Once an order has been placed however, .decimal securely stores the treatment device information on its servers for the time period required by the US FDA and users may request this information, | ||
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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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- | [[decimal3d: | ||
===== Release Notes ===== | ===== Release Notes ===== | ||
decimal3d/instructions_for_use/instructions_for_use.txt · Last modified: 2023/04/17 16:34 by kerhart