Boston Scientific Emblem MRI S-ICD Manuals

Manuals and User Guides for Boston Scientific Emblem MRI S-ICD. We have 1 Boston Scientific Emblem MRI S-ICD manual available for free PDF download: User Manual

Boston Scientific Emblem MRI S-ICD User Manual

Boston Scientific Emblem MRI S-ICD User Manual (70 pages)

Brand: Boston Scientific | Category: Pulse Generator | Size: 17 MB

Table of Contents

Table of Contents
3
Description

7
- Related Information
  7
- Intended Audience
  7
- Indications for Use
  7
- Contraindications
  7
- Warnings
  7
  - General
    7
  - Handling
    8
  - Implantation
    8
  - Post-Implant
    9
- Precautions
  9
  - Clinical Considerations
    9
  - Sterilization and Storage
    10
  - Implantation
    10
  - Device Programming
    11
  - Environmental and Medical Therapy Hazards
    12
  - Hospital and Medical Environments
    12
  - Home and Occupational Environments
    16
  - Follow-Up Testing
    18
  - Explant and Disposal
    18
- Supplemental Precautionary Information
  18
  - Potential Adverse Events
    19
Patient Screening

21
Operation

25
- General
  25
- Modes of Operation
  25
  - Shelf Mode
    25
  - Therapy on Mode
    25
  - Therapy off Mode
    25
- Sensing Configuration and Gain Selection
  26
- Sensing and Tachyarrhythmia Detection
  26
  - Detection Phase
    26
  - Certification Phase
    27
  - Decision Phase
    27
- Therapy Zones
  27
- Analysis in the Conditional Shock Zone
  28
- Charge Confirmation
  29
- Therapy Delivery
  29
- Smart Charge
  29
- Redetection
  30
- Shock Waveform and Polarity
  30
- Post-Shock Bradycardia Pacing Therapy
  30
- Manual and Rescue Shock Delivery
  30
- Additional Features of the S-ICD System
  31
- System Diagnostics
  32
- Storing and Analyzing Data
  33
  - Treated Episodes
    33
  - Untreated Episodes
    33
  - Captured S-ECG
    33
  - S-ECG Rhythm Strip Markers
    34
  - Patient Data
    35
- S-ICD System Magnet Use
  36
  - Magnet Use for Patients with Deep Implant Placement
    37
  - Magnet Response and Pulse Generator Mode
    38
- Bidirectional Torque Wrench
  39
Using the EMBLEM S-ICD Pulse Generator

39
Communication Compliance

56
- Radio and Telecommunications Terminal Equipment (RTTE)
  56
Additional Information

56
- Product Reliability
  56
- Pulse Generator Longevity
  57
- Specifications
  58
  - X-Ray Identifier
    58
- Definitions of Package Label Symbols
  65
- S-ICD System and Pacemaker Interaction
  67
- Warranty Information
  68

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