Boston Scientific 0128 Manuals

Manuals and User Guides for Boston Scientific 0128. We have 1 Boston Scientific 0128 manual available for free PDF download: Physician's Lead Manual

Boston Scientific 0128 Physician's Lead Manual

Boston Scientific 0128 Physician's Lead Manual (42 pages)

Steroid-Eluting Tined Endocardial Defibrillation Leads

Brand: Boston Scientific | Category: Medical Equipment | Size: 0 MB

Table of Contents

Table of Contents
4
Information for Use

6
- Device Description
  6
- Indications
  6
- Contraindications
  6
- Warnings
  6
  - Aicd/Lead Compatibility
    7
  - MRI Exposure
    7
  - Diathermy Exposure
    7
  - Implanting
    7
  - Electrical Performance
    8
  - Conversion Testing
    8
  - Securing and Tunneling
    8
  - Single Use Only
    8
- Precautions
  8
  - General
    8
- Adverse Events
  9
  - Observed Adverse Events
    9
  - Potential Adverse Events
    10
- Clinical Trial
  11
  - Clinical Investigation
    12
- Warranty
  15
Device Features

16
- Detailed Device Description
  16
Lead Evaluation

18
- Implant Information
  18
- Included Items
  18
- Opening Instructions
  19
- Sterilization
  19
- Surgical Preparation
  19
- Accessory Options
  19
  - Suture Sleeves
    20
  - Stylets
    20
  - Stylet Guide
    20
  - Vein Pick
    20
  - Lead Caps
    21
- Handling the Lead
  21
Implantation

22
- Inserting the Stylet
  22
- Inserting the Lead
  22
- Positioning the Lead
  25
- Minimizing Pacemaker Interaction
  26
- Checking for Lead Stability
  27
- Evaluating Lead Position
  27
  - Taking Baseline Measurements
    27
- Electrical Performance
  28
  - Evaluating with the Pulse Generator
    29
  - Evaluating with the PRM
    29
- Conversion Testing
  29
- Securing the Lead
  31
- Connection to a Pulse Generator
  34
Post-Implant Evaluation

35
- Follow-Up Testing
  35
- Explantation
  35
References

36
SPECIFICATIONS (Nominal)

37
Symbols on Packaging

38

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