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ManualsBrandsAvant ManualsElectronicsImplantable Cardioverter Defibrillator Device

Table Of Contents

Device Description
Intended Use
Indications
Intended Clinical Benefits
MRI Safety Information
Contraindications
Warnings
- Implantation Procedure
- Device Replacement
- Battery Incineration
- Storage and Handling
- High-Voltage Pulse Generator
- Magnetic Resonance Imaging (MRI)
Precautions
- Implantation Procedure
- Device Modification
- Storage and Handling
- Temperature Equilibrium
- Lead Impedance
- Suboptimal Bluetooth Communication
- Disconnecting Leads and Avoiding Shock While Handling
- External Equipment for Arrhythmia Induction
- Antiarrhythmic Drugs
- Sterilization
- Damaged Package
- Environmental Hazards
  - Device Communication
  - Additional Pacemaker
  - External Defibrillators
  - Electrosurgical Instruments
  - Therapeutic Radiation
- Hospital and Medical Environments
  - High Radiation Sources
  - Medical Lithotripsy
  - Diathermy
  - Ultrasound Therapy
- Environmental and Medical Therapy Hazards
- Home and Industrial Environments
- Transcutaneous Electrical Nerve Stimulation
- Radiofrequency Ablation
- Electronic Article Surveillance (EAS)
- Metal Detectors
- Cellular Phones
Adverse Events
Pulse Generator Header
- Lead Receptacle Connector Types
Sensing
Radiopaque Identification
Implanting the Pulse Generator
- Training Personnel
- Inspecting and Handling the Device
- Sterile Package and Contents
- Opening the Sterile Package
- Choosing the Implant Site
  - Pectoral Placement
    - Submuscular
    - Subcutaneous
  - Abdominal Placement
- Implanting the Leads and Testing the Device
  - Forming the Pocket and Connecting the Leads
Managing and Following Patients
- Patient Education
- Implant/Patient Registration Form
- Patient Follow-Up
Device Longevity
- Elective Replacement Indicator (ERI)
Using a Magnet
Explanting the Pulse Generator
Out-of-Service/Explant/Patient Death Form
Technical Support
Additional Information
- High-Voltage Waveforms
Physical Specifications
- Device Measurements
- Device Materials
- Noise Detection
- Charge Time
- Lead Compatibility
Battery Information
Device Configurations
Inductive Communication
BLE Operating Frequencies
Spare Parts and Accessories
Detection Performance in the Presence of Electromagnetic Interference in Differential Mode
Symbols

Noise Detection

Table 18. Noise detection

Model

Noise Detection Rate

All devices 100 or more sensed events per second

Charge Time

Table 19. Charge Time

Model

Charge Time

All devices Less than 10 seconds