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General| Imaging Technology | 3D Imaging |
|---|---|
| Detector Type | Flat Panel Detector |
| Generator Voltage | 60-90 kV |
| Type | Cone Beam Computed Tomography (CBCT) |
| Field of View (FOV) | Ø 5 cm x 5 cm |
| Voxel Size | 80 µm |
| Image Resolution | High resolution |
Introduction to the document, its purpose and structure.
Explanation of warning symbols and their meanings.
General safety information and precautions for using the device.
Defines the approved applications and patient types for the device.
Measures and guidelines for safe radiation handling.
General overview of the product and its components.
List of items included in the product's package.
List of accessories required for device operation.
Detailed technical specifications and parameters of the device.
Performance characteristics of the X-ray tube.
Physical dimensions of the device.
Description of the device's functions and operational modes.
Detailed explanation of how the device generates images.
Identification and description of the device's operating controls.
Instructions for navigating and using the touch screen interface.
Procedures for operating the device and acquiring images.
Instructions for attaching and using patient positioning aids.
Steps to correctly position the patient for X-ray acquisition.
Procedure to perform a test run for unit functionality.
Process of capturing an X-ray image.
How to use the emergency stop switch to halt the unit.
Procedures for cleaning and disinfecting the unit and accessories.
Guidelines for cleaning the external surfaces of the device.
Instructions for cleaning and disinfecting positioning aids.
Procedures for reprocessing medical device components.
Risk assessment for reprocessing medical devices.
Standardized procedure for device reprocessing.
Detailed steps for manual reprocessing.
Table of program parameters for image acquisition.
Specific parameters for CBCT imaging.
Specific parameters for panoramic imaging.
Data on scattered radiation levels.
Scattered radiation data for CBCT imaging.
Data on X-ray leakage rates.
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