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
11
Table 5. Possible causes and solutions for suboptimal BLE communication
Possible Causes
Solutions
The BLE dongle orientation or location is
suboptimal.
Move or reorient the Merlin PCS slightly. Make sure
that the BLE dongle faces the implantable device.
People or objects interfere with the
communication between the Merlin PCS and
the device.
Make sure that the space between the Merlin PCS and
the device is free from interfering objects or people.
The BLE dongle is too far away from the
device.
Move the Merlin PCS closer to the device.
Other products in the vicinity are causing
electromagnetic interference (EMI).
Power off or remove equipment that could cause EMI.
Disconnecting Leads and Avoiding Shock While Handling
Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia
therapies Off during surgical implant and explant or post-mortem procedures, and when
disconnecting leads. The device can produce electrical artifacts that can be sensed by the pulse