1.1. System Overview

1.1.1. Software Product Identification

SmartView Remote Monitoring Software 3.14
 08031527021188

1.1.1.1. Intended Use

The intended use of the SmartView Remote Monitoring Software (RMS) is to:

  1. Provide a web-based interface to manage patients followed remotely
  2. Generate interpreted PDF reports collected from patient device raw data, for presentation to the physician

1.1.1.2. Network Requirements

Communication with 2G/3G/4G cellular network must be available for collecting the device's raw data. An internet connection is required for the users to download PDF reports. If no 2G/3G/4G communication is available, reports cannot be transmitted to the user. Similarly, if no internet connection is available, users cannot access the software. Therefore, physicians cannot access the patient data.

Please note this software is not intended as an emergency response system. It is worth noting that in-clinic follow-up of pacemaker patients is still indicated and is in no way replaced, under any circumstances, by this remote monitoring technology.

1.1.1.3. Intended Users

The SmartView Remote Monitoring Software is intended to be used by qualified healthcare professionals only. The SmartView Remote Monitoring Software interfaces with the compatible MicroPort CRM monitoring devices at the patient’s home, and the physician’s screen via a web browser or application programming interface.

MicroPort CRM informs the physician and healthcare facility that

  1. execution of the SmartView Remote Monitoring Software on an IT network could result in previously unidentified risks to patients, users or third parties;
  2. the healthcare facility is advised to identify, analyze, evaluate and control these risks;
  3. subsequent changes to the IT network could introduce new risks and require additional analysis; and
  4. changes to the IT network include:
    1. changes in IT network configuration;
    2. addition of items (hardware and/or software platforms or software applications) to the IT network;
    3. removal of items from the IT network;
    4. update of hardware and/or software platforms or software applications on the IT network; and
    5. upgrade of hardware and/or software platforms or software applications on the IT network.

The remote monitoring system enables you to perform the following tasks:

  • Add users and patients
  • View and manage remote transmissions:
    • indicate completed and pending status
    • add comments
    • view all historical transmissions for a patient
  • Export transmission data in .pdf, .xml (Paceart® compatible and IEEE 11073 compatible) or source file formats
  • View patient lists with advanced filters:
    • by physician
    • by referral
    • by device
    • by implant date
    • by follow up date
  • Transfer patients:
    • to other clinics
    • accept into your clinic
  • View clinic reports:
    • monitoring device activities
    • monitoring device transmissions
    • monitoring device replacements
    • user activity (showing user response time for follow ups)
  • Manage your profile and reset your own password

For implantable devices allowing wireless communication, the remote monitoring system also allows you to:

  • View and manage scheduled transmissions
  • Create recurring automatic schedules:
    • for the clinic
    • for a patient
  • View and manage alert transmissions
  • Set physician notifications via email, fax and SMS
    • settings for critical alerts, significant alerts, and patient initiated transmissions
    • escalate to send a reminder alert for unopened alerts

1.1.1.4. Contraindications and/or limitations

No clinical contraindications as to the usage of SmartView RMS are known. No limitations as to the usage of the SmartView RMS are known.

1.1.2. System requirements

1.1.2.1. Web browsers

Our system is optimized for Windows operating systems and the following web browsers:

  • Internet Explorer 11
  • Firefox 60.0
  • Chrome 67.0

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1.1.3. Paceart®

You can download a Paceart® compatible file that can be imported into Paceart® 4.0

1.1.4. Source File

You can download a source file format (*.idf).

1.1.5. XML Format

You can export data as an IEEE 11073 report (*.xml).

1.1.6. Patient reports in PDF

You can download the patient reports to PDF onto your computer (*.pdf). In order to download the PDF reports, you can either click on the links as for the other export formats or click on the Save icon available in Acrobat Reader or select Save a Copy from the File drop-down menu. Browse the possible locations on your PC or the network where you can save a copy of a document. Click on the Save button.