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Study DeviceGenius PRP is a class II medical device with an 510(k)FDA clearance for platelet and
plasma separation for bone graft handling. Protocol numberTOYOSGENIUSPRP1701Study Title randomized
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Step 1: Start by reading the instructions manual that comes with the study device.
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Step 2: Familiarize yourself with the different components and features of the device.
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Step 3: Ensure that the device is fully charged or connected to a power source.
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Step 4: Turn on the study device by pressing the power button.
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Step 5: Follow the on-screen prompts or navigate through the device's menus using the provided buttons or touchscreen.
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Step 6: Fill out the study device by entering the required information, such as personal details or study parameters.
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Step 7: Double-check the entered information for accuracy before submitting it.
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Step 8: Once you have filled out all the necessary information, save or submit the data according to the device's instructions.
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Step 9: If applicable, securely store or transmit the filled-out study data as per the study protocol or guidelines.
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Step 10: When done using the study device, properly turn it off and disconnect it from any power source.
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What is study device?
Study device is a medical device that is used in clinical research studies or investigations.
Who is required to file study device?
The sponsor or investigator leading the clinical study is required to file the study device.
How to fill out study device?
The study device should be filled out with all relevant information regarding the medical device being used in the study.
What is the purpose of study device?
The purpose of study device is to document and track the use of medical devices in clinical research studies to ensure patient safety and study accuracy.
What information must be reported on study device?
The study device report must include details such as the name of the device, manufacturer, model number, and how it is being used in the study.
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