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About PCA 500
With the tremendous advancement in wearable technologies like smartwatches, there is still a big difference between a single lead ECG and a hospital-grade 12-lead ECGs. Single lead ECGs can detect abnormal rhythm patterns (arrhythmias) and AFIB; however, a 12-lead ECG remains the gold standard for comprehensive medical evaluation, such as for the diagnosis of arrhythmias, ischemic changes, QT interval changes, cardiomyopathy, myocarditis, and importantly, heart attacks (STEMI).
The QT Medical Personal Care Assistant (PCA 500) is FDA approved and is now available from MobilDrTech for purchase by Health Professionals and by patients with a physician’s prescription. It is the world's most compact 12-lead ECG system and, with its simplicity, ease of use and familiar interface on mobile platforms, the PCA 500 brings hospital-quality 12-lead ECG capability to many non-traditional areas.
The PCA 500 is useful for high risk patients who have had coronary artery bypass graft (CABG) surgery, or percutaneous coronary intervention (PCI, i.e. coronary stent). It is also designed for use by patients with chronic heart failure and arrhythmias.
The PCA 500 Starter Pak includes:
PCA 500 ECG Recorder with built in rechargeable LI-ION battery
Wall Charger, 3.7V, US-2pin
QT ECG Disposable Electrode Strips
Carrying Case for Recorder
In a clinical trial, over 95% of patients with no training, and no experience with ECGs, could do a full 12-lead ECG test after reading simple instructions. This revolutionary system will enable visiting nurses, home health personnel, nurses, med techs or patients with heart disease to do timely, high quality 12-lead ECG tests wherever the patient is located.
PCA 500 is digital, wireless, and mobile friendly. It is smaller than a deck of cards, fits in the shirt pocket, and works with iOS and Android phones and tablets.
Importantly, patented, proprietary electrodes can save significant time in ECG procedures and greatly reduce errors related to misplacement of electrodes and cable connections.
Remote or rural areas, sports venues, airlines and transportation systems, nursing homes/SNFs and patients’ homes are all areas with high potential for use. Other use cases include clinical trials, confined populations (jails and prisons), employee health and urgent care facilities. The small form factor and mobile App availability also make the PCA 500 ideally suited for a wide range of telemedicine applications anywhere there is an Internet connection.
PCA 500, combines hospital grade accuracy, mobile technology, advanced software and cloud-based management to set a new standard in cardiac care. Free mobile apps (Android & IOS) allow patients to send their ECGs to the cloud for evaluation.
With EKG360, QT Medical’s own diagnostic service, a network of cardiologists* can interpret the ECGs sent to the cloud and provide patients at home with a detailed report so they can consult their physician for the course of action. Providers and patients also have the option of sending ECGs to local cardiologists who have agreed to read and provide diagnostic reports.
The PCA 500 is the first and only FDA approved 12-Lead ECG that can be used in the home and operated by the patient themselves to perform a hospital-grade ECG. The data is instantaneously sent through the HIPAA compliant cloud to a physician for evaluation. Cloud based computer diagnostic algorithms for instant preliminary interpretation are currently available with no additional fee. Artificial Intelligence (AI) analytics, with much improved clinical accuracy, are under development and will be provided to all users in the near future. With PCA 500, healthcare facilities can streamline their workflow, minimize the needs for personnel training and maintenance, manage all ECG needs in the cloud and get more accurate results instantly.
*EKG360 cardiologist network currently available in California. Qualified, licensed practitioners in other states will be added as demand dictates.
Registrations & Certifications
The PCA 500 has received FDA 510k clearance in the United States.
For MobilDrTech customers in the European Union and the UK, the CE Mark has been applied for and is expected to be granted in Q1, 2020.
Discussions are currently ongoing with the National Health Service (NHS) in the United Kingdom.
Certification with Health Canada is planned and will be announced later.
Compact and Portable Resting 12-Lead ECG System
Built-in 700 mAh rechargeable Li-ion battery
16 hours continuous use
Wireless connectivity – Bluetooth
Dimensions: 7.2 x 6.8 x 1.8 cm (2.8 x 2.7 x 0.7 in)
Weight: 67 g (2.4 oz)
Patented Pre-Positioned Electrode Strips
Simplifies lead placement procedure
70% faster setup time
AHA & IEC compliant
Proven usable by providers or patients with no training
QT ECG Apps & Cloud Management System
Free Apps available for IOS and Android Phones and Tablets
1000Hz sampling rates suitable for pediatrics and adults
Adjustable gain and speed function
Serial comparison of different ECGs by superimposing waveforms
All documents and encrypted data transferred through secure connection to the cloud – HIPAA & GDPR compliant