MEDICAL PRODCUTS

We have extensive experience of manufacturing devices for the US, European and Asia Pacific markets. Specializing in hand held devices for self medication, we work closely with industry recognized design houses and human factors engineering consultants, ensuring that every product meets the specific needs of the end users.

Our medical devices manufacturing capabilities include:

  • Proprietary ECG Detection Module

  • Ambulatory ECG Telemetry Devices 

  • Drug Infusion Devices

  • Vital Signs Recording Patches

  • Respiratory Treatment Devices

Our production engineers work alongside human factors engineers making sure all products are:

  • Certified and Compliant with industry regulators

  • Pass Verification and Validation tests

  • Pass Clinical Evaluation reports

  • Pass Formative, Summative and Comparison Usability tests

  • Complete with product labelling, instructions and packaging

Inline with FDA regulations, the majority of manufacturing for medical products takes place in an ISO:13485 clean room facility. Substantial investment in recent years has allowed us to increase output and optimize our facilities for specific projects.

For any enquiries regarding medical products please get in contact with us at HQ@cardiosport.com

ECG

WIRELESS DETECTION MODULE

The ECG Detection Module is designed for use in ECG Holter and Telemetry monitors in the ambulatory healthcare market. Using our proprietary CBA9 ™ ASIC Biochip, the ECG Detection can process 2 channel ECG data (Lead I and Lead II) and broadcast data in Bluetooth Low Energy to multiple receivers. The main function is to convert an analogue ECG input signal into digital signals and send to a host controller and to detect the QRS complex generating a pulse signal and ECG wave. The emphasis on the design is very low power consumption and the ability to capture small input signal amplitudes, discerning valid signals from artefacts and noise with active filtering.

Designed to be used in Holter and Cardiac Event Monitoring devices, the ECG Detection Module can detect: Respiration, heart rate variability, QT analysis, ST segment analysis, patient rhythm morphology, atrial fibrillation, changes in ST segment, and other cardiac rhythm abnormalities.

 

The module design is compact and can be integrated into the smallest hardware, delivering long battery life from a coin cell battery. Tested with 1-2 Lead ECG telemetry wearable patches and fabric electrodes integrated into clothing, the ECG detection module is the ideal solution for the next generation of ambulatory cardiac monitors. Our proprietary algorithms can filter noises and artefacts caused by movement and detect consistent ECG accuracy during exercise and excessive movement.

Specification:

  • 3-Lead ECG Signal

  • Suitable for ECG Patches, Fabric sensors and 3M Red Dot Electrodes

  • Event Detection Algorithm

  • Recording Rate: 256 Sample/s

  • High Resolution 16bit ADC Output

  • Sampling rate from 128Hz - 1024Hz

  • Internal Memory

  • Bluetooth Low Energy

  • 7 Day Battery Life 

  • Rechargeable Battery or

  • CR2450 coin cell battery

  • Weight: 15g / 0.5 oz 

  • Diameter: 36.5mm

VSP

VITAL SIGN PATCH

VSP (Vital Sign Patch) is our 1-Lead ECG patch concept for wireless vital signs monitoring in a number of different ambulatory environments, including: Out Patients, EMS, First Responders and Military applications. Featuring our CBA9™ ASIC Biochip Module and Bluetooth Low Energy, VSP records wireless 1-Lead ECG, Respiratory Rate and Body Temperature in real time and broadcasts to multiple devices. Internal memory storage allows VSP to record data for up to 24 hours. 

The compact design is optimized to save weight and space when not in use and uses two replaceable 3M foam FDA approved ECG electrodes, ensuring accurate readings and zero movement or skin irritation. It is inexpensive to replace and ease of use. 

Specification:

  • 1 - Lead ECG Signal

  • CBA9™ Biochip Module

  • 2 Disposable 3M ECG Electrodes

  • Recording Rate: 200 Sample/s

  • High Resolution 16bit ADC Output

  • Up to 1Khz Sampling Rate

  • Bluetooth Low Energy

  • 7 Day Battery Life

  • CR2032 Battery

  • 13 x 4 cm

  • 28 grams

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