Cardea Associates was founded by experts who are passionate about saving lives through cardiovascular research and product innovation.
CardeaScreen is a portable ECG device that helps physicians to conduct Pre-Participation Exams (PPE) to identify abnormal heart conditions in young athletes who may be at risk for sudden cardiac arrest. It wirelessly connects via Bluetooth with analysis software that runs on a standard Windows-based PC.
The CardeaScreen system has two main subsystems:
A 12-Lead ECG Transmitter that connects to patients and transmits highly accurate ECG data.
A PC based software application with algorithm that analyzes the ECG data and presents ECG interpretations ready to be ready to be over-read and confirmed by a clinician.
Andrews-Cooper provided a turn-key solution to develop two versions of the CardeaScreen 12-lead ECG transmitter. We were responsible for all development activities – mechanical, electrical and software. Specific aspects of the design included:
12 Lead ECG
Rugged/Water Sealed Requirements – Increased ECG Transmitter’s water seal rating from IEC IPX2 to IP55.
Concept: concept design, requirements, planning
Design: responsible for all development activities, both hardware and software. This included:
All plastic parts
Tooling: Injection mold tooling, and procurement of all custom parts
Testing: written test protocols. Validation and Verification testing of all requirements. Used local test houses to complete EMC and Environmental testing.
Certification: Worked with Intertek to achieve required safety certification.
Manufacturing: Sourced an FDA certified contract manufacturer and successfully moved the product into production.
The CardeaScreen high bandwidth transmitter (0.05 – 150 Hz) digitizes at 1000 Hz and a resolution of less than 1 μVolt, compared to common industry standards of 500 Hz and 2.5-5 μVolt. The real-time recording screen continuously displays all of the ECG trace data, helping the clinician correct patient motion and other noise artifacts which commonly degrade ECG quality. Adaptive AC line filters remove pure line noise (e.g.: 60 Hz) without introducing the common “ringing” artifact associated with high-amplitude and narrow R waves. And the baseline wander filter effectively removes respiration artifacts without distortion of ST segments. The 16 second recording duration supports high-quality computation of median beats, particularly important for athletes with very low resting heart rates.