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Provides an introduction to the OPTIMIZER Integra CCM-D System and its purpose.
Outlines the conditions and patient types for which the system is indicated.
Details the features and functions of the Implantable Pulse Generator.
Introduces the Guardio Charger, its purpose, and where to find more details.
Lists common and uncommon risks related to the surgical implantation of the device.
Details potential issues that may arise during the use and operation of the device and charger.
Critical information regarding clinical study participation and device identification.
Provides instructions and advice for patient recovery after the implantation procedure.
Describes general expectations, resuming activities, and medication interactions.
Warns about potential interference from external electronic devices and magnets.
Important safety advice regarding medical procedures, MRI, and security screening.
Identifies and describes all parts of the Guardio Charger System and its key functionalities.
Explains the charging method and provides step-by-step instructions for charging the IPG and charger.
Explains how to terminate charging sessions and interpret alert codes for troubleshooting.
Guidance on charger placement, charging frequency, cleaning, and general maintenance.
Information regarding the expected lifespan and eventual replacement of the implanted pulse generator.
Answers to common questions about the IPG's function, activities, and replacement.
Details electromagnetic immunity and emissions standards for the IPG and Guardio Charger.
Explains the RF wireless technology, specifications, and communication quality between devices.
Provides steps to resolve issues with establishing a wireless connection between the IPG and Guardio Charger.
General| Device Type | Cardiac Contractility Modulation (CCM) Device |
|---|---|
| Delivery Method | Implantable |
| Therapy | Cardiac Contractility Modulation |
| Programmability | Yes |
| Implantation | Subcutaneous |
| Indication | Heart failure with reduced ejection fraction (HFrEF) |
| Therapy Delivery | Electrical pulses delivered to the right ventricular septum during the absolute refractory period of the cardiac cycle. |
| Lead Configuration | Dual-lead system |
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