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Pulse Generator
Proclaim 3662
Abbott Proclaim 3662 Manuals
Manuals and User Guides for Abbott Proclaim 3662. We have
1
Abbott Proclaim 3662 manual available for free PDF download: Clinician Manual
Abbott Proclaim 3662 Clinician Manual (81 pages)
Implantable Pulse Generator
Brand:
Abbott
| Category:
Pulse Generator
| Size: 2.41 MB
Table of Contents
Table of Contents
3
Prescription and Safety Information
5
Intended Use
5
Indications for Use
5
MRI Safety Information
5
Contraindications
5
Warnings
5
Precautions
7
Sterilization and Storage
8
Handling and Implementation
8
Hospital and Medical Environments
9
Home and Occupational Environments
9
Adverse Effects
10
System Overview
10
Product Description
11
Interaction Among Main System Components
11
Identifying the IPG
12
Package Contents
12
Directions for Use
12
Creating an IPG Pocket
12
Connecting a Lead or Extension to the IPG
13
Tighten the Setscrew Clockwise
15
Insert the Port Plug
15
Implanting the IPG
15
Replacing the IPG
16
Disposing of Explanted Components
16
Checking the Status of the IPG Battery
16
Technical Support
17
Product Materials
17
Product Specifications
17
Storage Specifications
17
Appendix A: Product Specifications
17
IPG Specifications
18
Operating Parameters for the IPG
19
Compatibility Guidelines for Ipgs with Compatible Headers
19
Compatible Medtronic Leads and Extensions
19
Programmers and Controllers
20
Leads and Extensions
20
Appendix B: System Components and Accessories
20
Ipgs
20
Adapters
21
Trial System
21
Appendix C: Battery Longevity Information
22
Energy Factors for Tonic Stimulation Parameters
23
Energy Factors for Burstdr Stimulation Parameters
27
Energy Factors for Various Burstdr Stimulation Parameters
27
Battery Longevity Graphs
29
Estimated Battery Longevity by Energy Factor for Proclaim Ipgs
29
Disposal Guidelines for Battery-Powered Devices
30
Appendix D: Regulatory Statements
30
Statement of FCC Compliance
30
Statement of Compliance with License-Exempt RSS Standard (Canada)
30
Identification Information for Product Registration
30
Bluetooth Smart Wireless Technology Information
31
Radio Transmitter, Cables, Transducers
31
Quality of Service for Wireless Technology
32
Wireless Security Measures
32
Troubleshooting for Wireless and Coexistence Issues
32
Efficacy Evaluation
33
Appendix E: Safety and Effectiveness Studies
33
Clinical Summary for the Genesis™ (IPG) Neurostimulation System for SCS
33
Summary of Risks Identified in the Retrospective Clinical Studies
35
Clinical Summary for Burstdr™ Stimulation
36
Accountability of Subject Cohort
40
Subject Accounting
40
Demographics and Primary Diagnosis
41
Pain Duration and Origin
43
Pain Treatment History
43
Summary of All Aes
45
Summary of Study-Related Saes
46
Summary of Non-Study Related Saes
46
Device and Device Usage Data
50
Percentage of Paresthesia Coverage
60
Additional Nonpowered Effectiveness
60
Pain Measures
60
Change in Overall VAS Score from Baseline to Week 12
61
Responder Rates
61
Device Satisfaction and Stimulation Preference
68
Subject Satisfaction Summary at Week 24
68
Psychosocial Health and Physical Function Measures
69
Summary of PGIC Questionnaire
69
Components of SF-36 Quality of Life Physical and Mental Scores
70
Summary of ODI Scores
71
Summary of SF MPQ-2 Scores
71
Summary of PCS Scores
73
Summary of BDI-II Scores
73
Pain Medication
74
Summary of Supplemental Clinical Information
74
Conclusions Drawn from the Study
74
Effectiveness Conclusions
74
Appendix F: Symbols and Definitions
77
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