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Aimed BreetheOXY1 SystemInstructions for Use & Reference Manuals RESPONSIBILITY The OXY1 System will perform in conformity with the description thereof contained in this manual and accompanying labels
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A data sheet for Abiomed typically contains detailed technical and performance specifications of their medical devices, particularly heart pumps and related products.
Healthcare providers, medical device distributors, and any involved entities that handle or utilize Abiomed products are required to file a data sheet to ensure compliance with regulations and proper usage.
To fill out a data sheet for Abiomed, users should provide relevant product information, patient data, operational parameters, and any adverse effects if applicable, following the guidelines attached to the data sheet template.
The purpose of the data sheet is to provide crucial information for monitoring device performance, ensuring patient safety, regulatory compliance, and aiding in the continuous improvement of medical technologies.
Information that must be reported includes device serial numbers, usage data, patient identifiers, operational outcomes, and any complications or side effects experienced during the use of the product.
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