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
19
Minimize radiofrequency ablation risks by:
Programming all tachyarrhythmia therapies off
Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator
Positioning the groundplate so that the current pathway does not pass near the pulse generator.
For example, place the groundplate under the patient's buttocks or legs
Having external defibrillation equipment available
Electronic Article Surveillance (EAS)
Advise patients that the Electronic Article Surveillance/Anti-theft (EAS) systems such as those at
the point of sale and entrances/exits of stores, libraries, banks, or tag readers that include radio
frequency identification (RFID) equipment emit signals that may interact with the device. To
minimize the possibility of interaction, advise patients to simply walk through these areas at a
normal pace and avoid lingering near or leaning on these systems.
Metal Detectors
Advise patients that metal detector security systems such as those found in airports and
government buildings emit signals that may interact with ICDs and CRT-Ds. To minimize the
possibility of interaction, advise patients to simply walk through these areas at a normal pace and
avoid lingering. Even so, the ICD and CRT-D systems contain metal that may set off the airport
security system alarm. If the alarm does sound, the patient should present security personnel with