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
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home appliances; arc or resistance welders; equipment with large motors; induction furnaces; very
large or defective electric motors; and internal combustion engines with poorly shielded ignition
systems.
The patient should avoid strong magnetic fields since they are potentially capable of inhibiting
tachyarrhythmia therapies. If a patient is frequently in a high-magnetic-field environment and
therefore at risk of not having therapies delivered, you may choose to program the device to ignore
magnetic fields. Therapies would then be delivered in the normal manner in response to detected
arrhythmias. Magnet application would have no effect on operation.
Advise patients to not play sports or engage in activities where there is a risk of repetitive blows to
the implanted device area.
Twiddler's Syndrome: Caution patients against manipulating the implanted device as it may result
in lead damage or lead displacement.
Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation (TENS) may interfere with device function. To reduce
interference, place the TENS electrodes close to one another and as far away from the device/lead
system as possible. Monitor cardiac activity during TENS use.
Radiofrequency Ablation
Radiofrequency ablation in a patient with a pulse generator may cause malfunction or damage.