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
2
Table 2. Dual-chamber pulse generator descriptions
Name
Model
Number
Description
Connector
Type
Delivered
Energy
(approx.)
MRI Status
Avant™ DR CDDRA700Q
Dual-chamber ICD
with BLE telemetry
DF4-LLHH/IS-1 40 J
MR
Conditional
Neutrino™
NxT DR
CDDRA800Q
Dual-chamber ICD
with BLE telemetry
DF4-LLHH/IS-1 40 J
MR
Conditional
CDDRA600Q
Gallant™
DR
CDDRA500Q
Dual-chamber ICD
with BLE telemetry
DF4-LLHH/IS-1 40 J
MR
Conditional
Entrant™
DR
CDDRA300Q
Dual-chamber ICD
with BLE telemetry
DF4-LLHH/IS-1 36 J
MR
Conditional
Abbott Medical DF4 connector cavities comply with ISO 27186:2010(E).
Abbott Medical IS-1 connector cavities comply with the international connector standard: ISO 5841-3.