Product Card
Table Of Contents
- Device Description
- Intended Use
- Indications
- Intended Clinical Benefits
- MRI Safety Information
- Contraindications
- Warnings
- 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
- Hospital and Medical Environments
- 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
- Sensing
- Radiopaque Identification
- Implanting the Pulse Generator
- Managing and Following Patients
- Device Longevity
- Using a Magnet
- Explanting the Pulse Generator
- Out-of-Service/Explant/Patient Death Form
- Technical Support
- Additional Information
- Physical Specifications
- 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
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antitachycardia pacing, cardioversion, or defibrillation. Additionally, high-energy induced or
conducted currents can reset the programmed parameters and damage the pulse generator and
tissue surrounding the implanted lead electrodes.
Device Communication
Communication with the device can be affected by electrical interference and strong magnetic
fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient
and the programmer. If the problem persists, contact Abbott Medical.
Additional Pacemaker
These devices provide bradycardia pacing. If another pacemaker is used, it should have a bipolar
pacing reset mode and be programmed for bipolar pacing to minimize the possibility of the output
pulses being detected by the device.
External Defibrillators
External defibrillation may damage the pulse generator. It may also result in temporary or
permanent myocardial damage at the electrode-tissue interface or temporarily or permanently
elevated pacing capture thresholds. Minimize current flowing through the pulse generator and lead
system by following these precautions when using external defibrillation on a patient with a pulse
generator:
- Position defibrillator paddles as far from the pulse generator as possible (a minimum of 13