The software and efficient file structure on which it is built offers remote monitoring services the fastest and most user-friendly environment to reduce the time spent in producing intuitive and accurate patient results. A number of proprietary features make this software unique and the most productive and highly regarded in clinical research and diagnostic communities.

ECG Data Review and Analysis Key Features:

• Advanced signal processing – Global Instrumentations M12A Enterprise Software Platform signal processing algorithms provide superior accuracy in beat detection, labeling, and noise rejection resulting in rapid identification of events and scanning of records.
• Afib beat detection & Afib burden reporting - The combination of the fully automated Afib detection combined with robust arrhythmia reviewing tools allows for complete AFIB assessment.
• Up to 21-day Holter analysis - Full support for extended Holter studies. Let the software sort and categorize thousands of beats during extended Holter monitoring. Trends, averages, totals, tables, etc., are automatically and rapidly adjusted providing minimal time to re-tabulate data post-editing.
• User friendly editing and graphical user interface - Use the intuitive configuration management tools to quickly set-up scanning criteria and report formats to satisfy unique client requirements. Final reports can be customized to include: company name, company logo, contact information, diagnostic terms, morphological terms, key phrases, and more.
• Import data from 3rd party Holter and patch recorders - The M12A Enterprise Software Platform features a proprietary interface to allow rapid integration of new recorder types including patch wearable sensors. Our solution is device agnostic.

  Sample screenshots from the M12A Enterprise Software Platform

  

• Customizable criteria and reports - Quickly create individualized reports and scanning criteria for specific clients with configuration management tools. This includes control of demographic information, page content, strip types, one or six day graphic summary with strips, and more.

  Sample summary report pages from an extended Holter Monitoring test

  

The M5 Recorder is an ultra-compact reusable ECG sensor ideal for extended duration ambulatory remote monitoring studies. Unlike many devices, the new M5 Recorders offers a wearable patch electrode that can be easily replaced by the patient to extend recording duration without jeopardizing data collection or requiring the patient to return to the clinic. Additionally, it is water-resistant, allowing patients the freedom to go about their daily routine without interrupting cardiac monitoring. Due to its small size, and its ability to be placed centrally on the chest, the M5 Recorder can effectively capture the P-wave.

The M5 Wearable ECG Recorder is fully integrated with the M12A Enterprise Software Platform to offer a best-in-class combination of cloud-ready data management, precise and efficient review & report generation, and patient-friendly use.

• Durable, compact and water-resistant recorder (suitable for showering)
• Patch electrode or multiple lead set alternatives using standard electrodes
• Minimal preparation—No skin abrasion
• FDA cleared for pediatrics and adults
• Up to 14 days continuous recording on a single battery charge
• Secure internal memory to store up to 21 days of 3-channel ECG data
• Real-time ECG lead and signal quality confirmation at patient set-up via BluetoothTM (BLE) link to M12A Enterprise Software Platform
• Electrodes can be replaced by patient if needed – simply swap and continue recording
• 3 axis-accelerometry provides position & motion reporting through the M12A Enterprise Software Platform

The M12A Enterprise Software Platform provides flexible and configurable options for enabling and controlling review and edit access to internal staff, outside scanning parties, and clinical site clients. 

For internal use within a monitoring or scanning center, the M12A Enterprise Software Platform offers multiple user role settings allowing basic review and editing functionality, to roles with full administrator rights for confirming and locking final reports. It also supports multiple tiers of confirmation which allows for initial technician, QC technician and final confirmation.

Remote monitoring or scanning service organizations with client physician sites spread in a wide geography can offer their clients a software license to provide HIPAA-compliant, secure, digital methods to move ECG data from the remote location to the analysis center. Following a quality review and desired editing, a summarized pdf report is returned to the provider. If desirable, the services company can allow review and editing rights. The M12A Enterprise Software Platform puts control of the physician client access in the hands of the service provider.

Flexible licensing frameworks are available to support named or concurrent users models, pay-per-use (PPU) methods, and all with the ability to easily add new users as you grow your business.

The M12A Enterprise Software Platform is designed to make management and deployment as easy as possible. A cost saving for scanning services and other multi-location service providers.

M12A Enterprise Software Platform Remote Cardiac Monitoring Deployment Scenarios

Flexible across remote monitoring applications, a real-time ECG monitoring algorithm for clinical decision support such as mobile cardiac telemetry (MCT) and the Retrospective Algorithm for continuous long-term recordings such as extended Holter monitoring.

The Global Instrumentation M12A Enterprise Software Platform ECG Monitoring Algorithms use advanced signal processing and analytics to provide highly accurate QRS detection, interval measurements, and rhythm interpretation for up to 3 channels of captured ECG data.

The algorithm performs continuous analysis of the ECG data. The analysis processing consists of the following components:

• Signal Conditioning
• QRS Detection
• Beat Classification and Clustering
• R to R Measurement
• Heart Rate Calculation
• Asystole, Ventricular Tachycardia, and Ventricular Fibrillation Detection

The Retrospective Algorithm contains the same element listed above as well as:

• Extensible Form clustering
• HRV Time Domain
• Automatic AFIB detection
• Various Trended patterns

By accurately interpreting the ECG waveform, the algorithm can be deployed in medical diagnostic systems to assist health care professionals assess patient cardiac status. The algorithms are designed to enable deployment in diverse platforms including cloud-based and remote mobile cardiac telemetry (MCT) services. The Real-Time Algorithm is also lightweight enough to embed in body-worn patch sensors.