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
13
addition, changing cardiac electrical characteristics may prevent detection of a tachyarrhythmia or
may cause the pulse generator to misinterpret a normal rhythm as a clinically significant
arrhythmia. Changes in medication may require defibrillation threshold testing, updating the
morphology template, and reprogramming of the device.
Sterilization
The package contents have been sterilized with ethylene oxide before shipment. This device is
FOR SINGLE USE ONLY and is not intended to be resterilized.
Do not implant the device when the sterility indicator within the inner package is purple, because it
might not have been sterilized, or when the storage package has been pierced or altered, because
this could have rendered it non-sterile.
Damaged Package
Do not use the device or accessories if the packaging is wet, punctured, opened or damaged
because the integrity of the sterile packaging may be compromised. Return the device to Abbott
Medical.
Environmental Hazards
External devices generating strong electromagnetic fields can cause operational problems in the
pulse generator that include: cessation of or intermittent bradycardia pacing, and inadvertent