The Health-Patch is intended to measure and record physiological signals like ECG, bioimpedance, accelerometer and others for research applications. The Health-Patch continuously records health data up to 5 days for offline analysis and processing. The Health-Patch consists of a non-disposable recorder, a disposable dry electrode electrode array with integrated main unit holder, a docking station for high-speed data download and a wireless USB dongle for live visualisation and verification of correct functioning.
Optionally the Health-Patch can be delivered with standard Ag/AgCl electrodes.
Medical, Professional sports & defense applications
The health-patch platform can be used for a wide variety of applications in medical, sports and defense applications. The health-patch platform is especially suited for high-quality, long term (upto 5 days) raw data collection for offline (AI) algorithm development. The health patch is lightweight and easy to use for the user and care provider. Besides offline data collection the health-patch platform can also stream raw or summarized biosignals using Bluetooth LE.
Wearable Health Patch Technology Platform
The Health-Patch technology consists of a number of universal applicable building blocks, which can quickly be reconfigured for different applications.
The current health patch is focussed around a single lead ECG measurement, but the underlying technology platform is also suited to create solutions that require 2 lead (Einthoven triangle) or multi lead ECG recorders.
With small modifications the internal amplifiers can be used to measure ExG signals to track muscle, eye or brain activity depending on the exact application.
Besides ExG signals the health-patch platform also measures bioimpedance. This is currently used for breathing rate measurement but is also interesting for other applications.
Activity & Motion
In the health patch platform there is a 16G accelero sensor which measures, vibrations, shock, G-Force and direction towards the earth gravitational field. The hardware also contains gyroscope and magnetometer sensors for tull 9 DOF motion tracking applications.
On the patch also (skin) temperature can be measured. This function is currently under development and will be validated in the coming months.
Joint development of 2M Engineering & TNO/Holst
TNO at Holst Centre and 2M Engineering have jointly developed a Health Patch. Expertise of TNO/Holst is printed & flexible electronics and expertise of 2M is on product creation, certification and production.
We believe the health-patch platform will help healthcare companies around the world to bring customized wearable devices to market, targeting pre- and post-operative monitoring, ambulatory monitoring and a variety of specific conditions such as Chronic Obstructive Pulmonary Disease (COPD), Inflammatory Bowel Disease (IBD), and for the remote monitoring of Covid-19 patients.
Furthermore, because of its modular design, additional vital function measures can be integrated, such as oxygen saturation and vascular dynamics.
Wearable Health Patch – ECG, BR, ACC
The health-patch beta prototype shown on the right includes a number of the learnings of the proof of concept version and fully complies with the CE directives and requirements. This version which is intended exclusively for clinical investigations complies with the applicable safety, EMC, biocompatibility and radio standards.
Disposable electrode patch
The wearable health patch consists of a disposable electrode patch with recorder holder which is sticked to chest of the user. The printed electronics is flexible, uses innovative dry electrode materials that can breath.
Reusable Data recorder / Streamer
The health-patch recorder is slided into the electrode patch holder and collects & stores raw ECG (250sps), BR, ACC data up to 5 continuous days. The event marker button can be used to mark events and only essential information is presented to the user. The health-patch recorder is IP67 waterproof.
The recorder uses Bluetooth LE connectivity to set up, start and stop recordings wirelessly. The wireless interface is also used for live or summarized data streams. The recorder can easily be integrated in third party software applications via the API. The API can be customized for specific applications.
Health-Patch PC application
The Health-Patch PC application is used to:
- Setup a new measurement
- Live streaming visualizations
- Download and store recordings
The health-patch PC application is mostly for research applications. Creation of custom smartphone applications is possible using the open device API.
Live data streaming
The live data stream can be used to check correct placement and functioning of the electrodes before the user / patient is going home. This way the care provider can ensure that the system is functioning correctly/
For custom applications the recorder can process the raw data using signal processing algorithms. This can reduce the raw data and extract the real information early in the process, which reduces overall device power and wireless/storage constraints in other parts of the chain.
Monitor the heart function, detect arrhythmias, heart rate, heart rate variability. Lead on/off detection.
AC input range: 16mVpp
DC input range: -320mW to +340mW
Sample rate: 250sps
Resolution: 24/16bit effective.
Monitor body activities, G-force and postures
Range: +/- 16G
Dimensions: X, Y, Z
DC accuracy: +/- 0.02G
Sample rate: 64Hz
Resolution: 12 bit
Magnetometer & gyroscope hardware prepared.
Breathing rate monitoring
Sample rate: 64Hz
Mark specific events by pressing the button
70 x 40 x 10mm
High-resolution data storage
Store raw measurement data for periods up to 5-7 days without recharge.
Wireless data streaming
Wireless raw or event based data streaming using Bluetooth Low Energy. Remote start, stop of recordings. Live data visualization.
Bluetooth Low Energy 5.2
Custom wearable health patch solutions
Different applications, use cases and specifications require different technical implementations. The health-patch platform is a solid basis for OEM product development. Based on client specifications we create custom solutions, including the required changes to the flexible electronics, hardware, product design, functionality and embedded algorithms. 2M is also experienced in the medical device certification and production of the complete solution.
Sensors & hardware
The hardware of the health patch platform is modular and allows extension with additional sensors like skin temperature or blood oxygen saturation sensor. Other sensors like EMG, EEG, EOG sensors are possible on request.
Functionality & software
The functionality of the device and application programming interface can easily be changed based on client’s specifications to meet the exact requirements for the specific application.
The overall aesthetics of the product and specific mechanical requirements with respect to biocompatibility and waterproofness are customizable. We believe in fast prototyping but can support all the way to high-volume production techniques.
Web, app & Cloud
2M delivers also website interfaces, custom PC applications for Windows or MAC, or Smart devices (Android or iOS). Including Cloud data storage and data processing.
Biomedical signal processing
The wearable health patch platform is our basis for creation of specific OEM products and dedicated solutions. By using smart algorithms that detect specific events or compress the datastream really power efficient solutions can be created. Low power consumption is essential for making these wearable products small and lightweight. 2M is specialized in smart algorithm development, validation and certification for embedded solutions. This enables new possibilities for accurately tracking treatment, emergency detection or (chronic) disease management.
Medical device certification
2M is experienced in medical device certification and has the required medical quality systems in place. From device classification, to risk analysis to tests at testhouses and the full documentation.
2M is experienced in executing small scale and larger production volumes. This can be done inhouse or via one of our partners.