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
8
Storage and Handling
Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia
therapies Off during surgical implant and explant or post-mortem procedures, and when
disconnecting leads. The device can deliver a serious shock if you touch the defibrillation
terminals while the device is charged.
For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity setting and
the lowest possible setting of Ventricular Sensitivity, 0.2 mV, may be more susceptible to EMI
according to testing required by ISO 14117 clause 4.5.2. The devices comply with the
electromagnetic compatibility requirements of ISO 14117 clause 4.5.2 at atrial and ventricular
sensitivities of 0.3 mV and less sensitive settings.
High-Voltage Pulse Generator
Perform all defibrillation testing with the pulse generator in the pocket.
Magnetic Resonance Imaging (MRI)
MR Conditional ICDs and CRT-Ds. Testing has demonstrated that the Abbott Medical
MR Conditional system is conditionally safe for use in the MRI environment when used according
to the instructions in the MRI-Ready Systems manual. The Abbott Medical MR Conditional system
includes an Abbott Medical MR Conditional device connected to one or more Abbott Medical
MR Conditional leads.