Overview
The Boston Scientific WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems are specialized medical devices, which are subject to specific guidelines for full body Magnetic Resonance Imaging (MRI) scans. This user manual details the protocols to ensure MRI safety and effectiveness while the devices are implanted in patients. It is essential for healthcare professionals to comprehend this manual in its entirety before conducting such scans.
Important Notices and Regulatory Compliance
The manual begins by specifying that the WaveWriter Alpha systems are embedded with ImageReady MRI Full Body Technology, thus permitting MRI scans under certain stipulations. It underscores the compulsory requirement for a physician’s order for the sale, distribution, and use of these systems, as enforced by Federal law.
Device Utilization and Modification Rights
For the non-MRI related implantation process, features, programming, and use, it redirects readers to the product manuals specific to the WaveWriter Alpha systems. Privileges of Boston Scientific Corporation include the right to amend product information and illustrations without prior notification to enhance product reliability and functionality.
Trademark and Legal Rights
A list of trademarks owned by Boston Scientific and associated affiliates is furnished, indicating legal ownership of device nomenclature such as ImageReady, WaveWriter Alpha, and several others.
Comprehensive Information and Labeling
The device user manual provides references to additional documents that should be consulted for a more extensive understanding of the devices’ indications, contraindications, warnings, and precautions. These include the Indications DFU (Directions for Use), the Information for Prescribers DFU, and a separate document covering labeling symbols. The relevance of reading all product labeling prior to device usage is highlighted for implanting physicians.
Warranty and Support
Warranty information can be found through Boston Scientific’s designated warranty website. This emphasizes the company’s commitment to after-sale support and customer care.
Conclusion
Overall, the first two pages of the user manual serve as an introductory section, providing an overview of the device’s capability for safe MRI usage, emphasizing compliance with legal restrictions, and offering preliminary guidance for healthcare providers. It also directs medical professionals to additional resources that cover a broader scope of information required for the WaveWriter Alpha and WaveWriter Alpha Prime systems.
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