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
17
Diathermy
Avoid diathermy, even if the device is programmed off, as it may damage tissue around the
implanted electrodes or permanently damage the pulse generator.
Ultrasound Therapy
The device should not be exposed to therapeutic levels of ultrasound energy, as the device can
inadvertently concentrate the ultrasound field and cause harm that might not be immediately
detectable. Diagnostic ultrasound treatment is not known to affect the function of the device.
Environmental and Medical Therapy Hazards
Advise patients to avoid devices that generate a strong electric or magnetic interference (EMI). EMI
could cause malfunction of or damage to the pulse generator, resulting in non-detection or delivery
of unneeded therapy. Moving away from the source or turning it off will usually allow the pulse
generator to return to its normal mode of operation.
Advise patients to avoid any areas marked with a "No Pacer" symbol.
Home and Industrial Environments
A variety of devices produce electromagnetic interference (EMI) of sufficient field strength and
modulation characteristics to interfere with proper operation of the pulse generator. These include:
high-powered radio, television, and radar transmitters/antennas; high-voltage transmission lines;