1.1. System Overview

1.1.1. Software Product Identification

SmartView Remote Monitoring Software 3.13

	08031527013893

1.1.1.1. Intended Purpose

The SMARTVIEW Remote Monitoring Software (RMS) is a standalone medical software, embedded on a central server (Back Office - BO), that is intended to make the data stored in the compatible implanted device available to the physician, thereby ensuring remote patient management.

The intended purpose of the SMARTVIEW Remote Monitoring Software (RMS) is to provide the physician with:

• a web-based interface allowing patient management through the monitoring of patients’ device data, and
• interpreted PDF reports built from patients’ device data stored on MicroPort CRM Back-Office.

Please note that:

• The SMARTVIEW Remote Monitoring Software (RMS) is not intended to work as an emergency response system
• The SMARTVIEW Remote Monitoring Software (RMS) does not modify the intended use/indications of use of the implant, nor does it modify the patient care in any way.
• The use of the SMARTVIEW Remote Monitoring Software (RMS) does not replace regular “in-clinic” follow-up

1.1.1.2. Performance and Safety

The performance of SmartView Remote Monitoring Software is to ensure the integrity of the data collected from a MicroPort compatible implanted cardiac device through a compatible patient’s monitoring device, and the display of this data to the physician.

Any serious incident in relation to the device should be reported to MicroPort CRM and the local Competent Authority.

The Summary of Safety and Clinical Performance (SSCP) will be available at https://ec.europa.eu/tools/EUDAMED after the launch of European Database on Medical Devices/ Eudamed.

1.1.1.3. Compatible devices

The SMARTVIEW compatible MicroPort pacemakers and defibrillators displayed below are grouped according to the type of technology used.

1.1.1.3.1. Remote Monitoring Technology: Inductive Telemetry

Remote Monitoring device: Smart Spot (previously Smartview Hot Spot)

Compatible Implantable devices:

• REPLY-SR, REPLY-D, REPLY-DR, FACIL-DR, REPLY-VDR, REPLY-CRT-P 
• ESPRIT-S, ESPRIT-SR, ESPRIT-D, ESPRIT-DR 
• REPLY200-SR, REPLY200-DR 
• KORA100-SR, KORA100-DR, KORA250-SR, KORA250-DR
• ENO-SR, ENO-DR, TEO-SR, TEO-DR, OTO-SR, OTO-DR

1.1.1.3.2. Remote Monitoring Technology: Bluetooth Low Energy (BLE)

Remote monitoring device: SmartView Connect

Compatible Implantable devices:

• ALIZEA-SR, ALIZEA-DR, BOREA-SR, BOREA-DR, CELEA-SR, CELEA-DR
• ENERGYA DF1-VR, ENERGYA DF4-VR, ENERGYA DF1-DR, ENERGYA DF4-DR, ENERGYA DF1-CRT-D, ENERGYA DF4-CRT-D, ENERGYA 4LV-CRT-D
• TALENTIA DF1-VR, TALENTIA DF4-VR, TALENTIA DF1-DR, TALENTIA DF4-DR, TALENTIA DF1 SonR CRT-D, TALENTIA DF4 SonR CRT-D, TALENTIA 4LV SonR CRT-D

1.1.1.3.3. Remote Monitoring Technology: Radio Frequency (RF) Telemetry

Remote Monitoring device: Smart Monitor (previously Smartview Monitor)

Compatible Implantable devices:

• PARADYM RF-VR, PARADYM RF-DR, PARADYM RF-SonR, PARADYM RF-CRT
• INTENSIA-VR, INTENSIA-DR, INTENSIA-SonR, INTENSIA-CRT
• PLATINIUM-VR, PLATINIUM-DR, PLATINIUM-CRT-D, PLATINIUM-SonR CRT-D
• ULYS DF1-VR, ULYS DF1-DR, ULYS DF4-VR, ULYS DF4-DR
• EDIS DF1-VR, EDIS DF1-DR, EDIS DF4-VR, EDIS DF4-DR
• GALI DF1-CRT-D, GALI DF1-SonR CRT-D, GALI DF4-CRT-D, GALI DF4-SonR CRT-D, GALI 4LV-CRT-D, GALI 4LV-SonR CRT-D

1.1.1.4. Indication and target population

1.1.1.4.1. Indication

The SMARTVIEW Remote Monitoring Software (RMS) is indicated for the remote follow-up of patients who are implanted:

• with a compatible MicroPort pacemaker according to the applicable Medical Guidelines (2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay), or
• with a compatible MicroPort defibrillator according to the applicable Medical Guidelines (2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death).

The corresponding clinical conditions regarding pacemaker and defibrillator implantation are detailed hereafter.

According to guidelines, a pacemaker is mainly indicated for the following conditions:

Accepted patient conditions warranting chronic cardiac pacing include:

• symptomatic paroxysmal or permanent second- or third-degree AV block;
• symptomatic bilateral bundle branch block;
• symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders;
• bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias;
• vasovagal syndromes or hypersensitive carotid sinus syndromes.

Synchronous atrioventricular pacing is indicated for patients who may benefit from maintenance of AV synchrony and for the treatment of conduction disorders that require restoration of both rates and which include:

• various degrees of AV block to maintain the atrial contribution to cardiac output;
• VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm.
• Low cardiac output or congestive heart failure secondary to bradycardia.

Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in physical activity.

Guidelines on cardiac pacing are provided by the European Society of Cardiology (2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi:10.1093/eurheartj/ehab364), and the American College of Cardiology and the American Heart Association (2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol. 2013; 61(3):e6-75).

According to guidelines, a defibrillator is indicated in: 

• Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. 
• Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.
• Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study.
• Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
• Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
• Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular fibrillation or sustained VT at electrophysiological study.

For further details please refer to “2008 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” and its 2012 Focused Update or “2017 AHA/ACC/HRS Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death” or “2015 ESC Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death”.

According to guidelines, a cardiac resynchronization therapy defibrillator is indicated in: 

• Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes.
• Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.
• Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study.
• Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
• Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
• Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular fibrillation or sustained VT at electrophysiological study.
• Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced LVEF and wide QRS.

For further details please refer to “2008 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” and its 2012 Focused Update or “2017 AHA/ACC/HRS Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death” or “2015 ESC Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death”.

For biventricular pacing therapy, please also refer to “2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi:10.1093/eurheartj/ehab364”.

1.1.1.4.2. Target population

The population targeted for the device is the patient population for which the device is indicated excluding pediatric subjects.

1.1.1.5. Intended Clinical Benefits

The intended clinical benefit of the SMARTVIEW Remote Monitoring Software (RMS) is remote patient management. It allows physicians to remotely monitor device/patient status; physicians can access the back-office data management system and generate interpreted PDF reports.

There is no direct clinical benefit of SMARTVIEW Remote Monitoring Software (RMS): this device is not claiming clinical benefit that can be specified through measurable, patient-relevant clinical outcome(s).

1.1.1.6. 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.

1.1.1.7. 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

1.1.1.8. 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.

1.1.1.9. Warnings and precautions

1.1.1.10. Residual risks and any undesirable effects

There is no residual risk for the SMARTVIEW Remote Monitoring Software after implementation of risk control measures. SMARTVIEW Remote Monitoring Software has no undesirable effect.

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.