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Manuals
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Abbott Manuals
Pulse Generator
Proclaim 3662
Clinician manual
Abbott Proclaim 3662 Clinician Manual
Implantable pulse generator
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Table Of Contents
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Contents
Table of Contents
Troubleshooting
Bookmarks
Table of Contents
Table of Contents
Prescription and Safety Information
Intended Use
Indications for Use
MRI Safety Information
Contraindications
Warnings
Precautions
Sterilization and Storage
Handling and Implementation
Hospital and Medical Environments
Home and Occupational Environments
Adverse Effects
System Overview
Product Description
Interaction Among Main System Components
Identifying the IPG
Package Contents
Directions for Use
Creating an IPG Pocket
Connecting a Lead or Extension to the IPG
Tighten the Setscrew Clockwise
Insert the Port Plug
Implanting the IPG
Replacing the IPG
Disposing of Explanted Components
Checking the Status of the IPG Battery
Technical Support
Product Materials
Product Specifications
Storage Specifications
Appendix A: Product Specifications
IPG Specifications
Operating Parameters for the IPG
Compatibility Guidelines for Ipgs with Compatible Headers
Compatible Medtronic Leads and Extensions
Programmers and Controllers
Leads and Extensions
Appendix B: System Components and Accessories
Ipgs
Adapters
Trial System
Appendix C: Battery Longevity Information
Energy Factors for Tonic Stimulation Parameters
Energy Factors for Burstdr Stimulation Parameters
Energy Factors for Various Burstdr Stimulation Parameters
Battery Longevity Graphs
Estimated Battery Longevity by Energy Factor for Proclaim Ipgs
Disposal Guidelines for Battery-Powered Devices
Appendix D: Regulatory Statements
Statement of FCC Compliance
Statement of Compliance with License-Exempt RSS Standard (Canada)
Identification Information for Product Registration
Bluetooth Smart Wireless Technology Information
Radio Transmitter, Cables, Transducers
Quality of Service for Wireless Technology
Wireless Security Measures
Troubleshooting for Wireless and Coexistence Issues
Efficacy Evaluation
Appendix E: Safety and Effectiveness Studies
Clinical Summary for the Genesis™ (IPG) Neurostimulation System for SCS
Summary of Risks Identified in the Retrospective Clinical Studies
Clinical Summary for Burstdr™ Stimulation
Accountability of Subject Cohort
Subject Accounting
Demographics and Primary Diagnosis
Pain Duration and Origin
Pain Treatment History
Summary of All Aes
Summary of Study-Related Saes
Summary of Non-Study Related Saes
Device and Device Usage Data
Percentage of Paresthesia Coverage
Additional Nonpowered Effectiveness
Pain Measures
Change in Overall VAS Score from Baseline to Week 12
Responder Rates
Device Satisfaction and Stimulation Preference
Subject Satisfaction Summary at Week 24
Psychosocial Health and Physical Function Measures
Summary of PGIC Questionnaire
Components of SF-36 Quality of Life Physical and Mental Scores
Summary of ODI Scores
Summary of SF MPQ-2 Scores
Summary of PCS Scores
Summary of BDI-II Scores
Pain Medication
Summary of Supplemental Clinical Information
Conclusions Drawn from the Study
Effectiveness Conclusions
Appendix F: Symbols and Definitions
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Proclaim™ Implantable Pulse Generator
Models 3660, 3661, 3662, 3663, 3665, 3667
Clinician's Manual
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