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General| Brand | Boston Scientific |
|---|---|
| Model | ENDOTAK RELIANCE |
| Category | Medical Equipment |
| Language | English |
Details the leads, their components, and intended use in AICD systems.
Lists patient contraindications and critical safety warnings for lead use.
Covers safety concerns related to MRI and diathermy environments.
Guidelines for electrical performance, conversion testing, securing, and general precautions.
Summarizes adverse events and findings from clinical studies.
Details on obtaining a limited warranty certificate for the lead.
Explains the specific components and design features of the leads.
General guidance on implant procedures, necessary items, and opening instructions.
Covers sterilization, surgical prep, and available accessory options.
Describes tools and techniques for handling and positioning the lead.
Explains lead cap usage and critical precautions for lead handling.
Step-by-step instructions for inserting the stylet into the lead.
Details methods for inserting the lead into the venous system.
Guidance on correctly positioning the lead and verifying its stability.
Procedures for evaluating lead position, electrical performance, and conversion testing.
Techniques for securing the lead and tunneling it to the implant site.
Guidelines for connecting the lead terminals to the AICD pulse generator.
Recommendations for post-implant evaluation and testing of lead performance.
Instructions for returning explanted leads for analysis and proper disposal.
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