Introduction
The St. Jude Medical SJM Biocor Valve is a medical device intended for use in patients requiring a replacement heart valve. This user manual provides vital information to physicians on the correct use, indications, contraindications, warnings, precautions, and adverse events associated with the valve. Additional sections cover the clinical studies, individualization of treatment, patient counseling, packaging and storage instructions, directions for use, and a patient registration guide.
Contents Overview
Beginning with a device description, the manual outlines the design and intended use of the SJM Biocor Valve. It proceeds to discuss indications for use, which are specific clinical scenarios where valve replacement is appropriate, followed by contraindications that highlight when the device should not be used.
A detailed section on warnings and precautions alerts to potential risks and safety information, including MRI compatibility. This is particularly important for patient management and safety considerations. Included in this section are comprehensive details about adverse events, both observed and potential, which must be understood to inform patients correctly and manage expectations.
The manual addresses clinical studies that provide evidence for the effectiveness and safety of the valve. For a tailored treatment approach, there is guidance on the individualization of treatment, underscoring the importance of anticoagulant and antiplatelet therapy, as well as considerations for specific patient populations.
Patient counseling information is essential for informing patients about the valve, its functionalities, and the surgical process. Furthermore, to ensure device integrity until use, the manual includes instructions for packaging and storage.
The directions for use section is a critical part of the manual, presenting a step-by-step process starting from pre-implant handling to the actual implantation. It covers various procedures such as removing the valve from packaging, rinsing, surgical guidelines, sizing, and intra-operative assessment. A subsection on MaraŃ Valve Implantation suggests a specific method for implanting this valve type.
After the successful utilization of the SJM Biocor Valve, there is a provision for patient registration. This helps in tracking and post-market surveillance. Lastly, the manual details the limited warranty provided by St. Jude Medical for this device, which denotes the terms under which the product is guaranteed.
The user manual is a comprehensive document intended to guide healthcare professionals through all the necessary steps and considerations for the safe and effective use of the SJM Biocor Valve. It must be read thoroughly before the device is used on a patient.
References:
Download: St. Jude Medical Physician’s Manual SJM Biocor Valve
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