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
65
Detection Performance in the Presence of Electromagnetic
Interference in Differential Mode
The Atrial Sensitivity setting of 0.2mV and Ventricular sensitivity 0.3mV (Low Frequency Attenuation
Filter ON) may be more susceptible to EMI (as defined by ISO 14117 clause 4.5.2).
Atrial Sensitivity of 0.3mV (and less sensitive settings) and Ventricular Sensitivity of 0.3mV and less
sensitive settings (Low Frequency Attenuation Filter Off) and 0.4 mV and less sensitive settings (Low
Frequency Attenuation Filter On) comply with the requirements of ISO 14117 clause 4.5.2, which
requires that the implantable pulse generator shall be constructed so that commonly encountered
electromagnetic signals are unlikely to be confused with sensed beats and to change the therapeutic
behavior of the implantable pulse generator.
The common mode rejection ratio for this device for 16.6 Hz, 50 Hz and 60 Hz is higher than a factor of
100.