Heart Connect Remote Software 5.5

The Heart Connect™ System is an optional data-sharing platform designed to effectively display and share physiological and medical data sourced from connected medical devices. This system enables healthcare providers and personnel from Boston Scientific to set up online meetings, facilitating the sharing of video feeds from connected devices with remote participants.

Heart Connect enhances the efficiency of patient care through several key features:

• Facilitates the exchange of clinical expertise among colleagues during complex clinical scenarios.
• Provides real-time technical guidance during the utilization of connected medical equipment.
• Aids in the training of clinical staff.
• Enables on-screen annotations for clearer communication.
• Supports various settings including implant procedures, follow-up device checks, and satellite clinic locations.

The Heart Connect Model 3935 iOS Remote Software application allows remote users to engage in online meetings initiated by local users or other remote participants. Through this application, remote users can:

• Join online meetings upon invitation.
• View live video feeds from connected medical equipment.

The Heart Connect Remote Software application is designed to be used specifically with the Heart Connect System Model 3933. For implementation support, interested parties are encouraged to consult their local Boston Scientific representative.

Intended Use

The Heart Connect System aims to share vital physiological and other medical data from compatible medical devices, thus enhancing communication among healthcare providers and Boston Scientific personnel during patient care.

Contraindications

This system should not be used with medical devices that do not meet the compatibility standards outlined in the Instructions for Use documentation.

Warnings

Utilizing any cables or accessories beyond those provided with the Heart Connect System may lead to increased emissions or reduced immunity. The system must be kept at least 1.5 meters (4.9 feet) away from patients and is deemed MR unsafe, requiring it to remain outside MRI Zone III and higher. Additionally, this system is non-sterile and cannot undergo sterilization processes.

Precautions

Access to patient data should be restricted to authorized healthcare providers and Boston Scientific personnel. Modifications to system settings should only be performed under the guidance of authorized personnel. Connection of USB drives must be limited to authorized users to prevent unauthorized changes to the system. It is advisable for local users to securely store the Heart Connect System when not in operation. In cases of unexpected behavior, restarting the system is recommended; however, persistent issues should prompt users to cease operations and contact Boston Scientific Technical Services for assistance, as detailed in the product manual.

Adverse Effects

No known adverse effects have been reported.

Please refer to the product labeling for detailed indications, contraindications, warnings, precautions, and any adverse events associated with use. Rx only.