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
33
Inspecting and Handling the Device
Inspect the packaging before removing the device. Do not implant the pulse generator if:
The package is damaged or wet
The dot on the ethylene oxide label is purple
Purple indicates that the package has not been sterilized.
The Use Before Date on the outer box and the tray has been exceeded
The Use Before Date reflects the minimum battery voltage required to support the calculated
battery longevity shown in the programmer's on-screen help.
The pulse generator has been sterilized using ethylene oxide gas. If the sterile package has been
compromised, return the device to Abbott Medical.
CAUTION: The device is for single use only and is not intended to be resterilized.
CAUTION: Do not submerge pulse generators in liquids or liquid baths.
CAUTION: The pulse generator should not be autoclaved, immersed in sterilant liquids,
gamma-irradiated, or ultrasonically cleaned.