VerityVital

VerityVital is a specialized Remote Patient Monitoring (RPM) data synchronization tool designed to securely capture and transmit vital health data from clinical-grade external hardware to healthcare providers.

CRITICAL HARDWARE REQUIREMENT:
This application CANNOT function independently and does not measure vital signs using mobile device sensors. It acts strictly as a secure data bridge and requires a physical connection via Bluetooth Low Energy (BLE) to specific, external medical devices. To use this app, patients must be issued one or both of the following approved hardware monitors by their contracted healthcare provider:
1. A&D Medical UA-651BLE Blood Pressure Monitor
2. A&D Medical UP-200BLE Pulse Oximeter

The application automatically handles the secure synchronization of data (Systolic/Diastolic pressure, SpO2, and Pulse Rate) directly from these external devices to your healthcare provider's clinical backend system.

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DISCLAIMER
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EMERGENCY SITUATIONS:
If you are experiencing a medical emergency, chest pain, or shortness of breath, DO NOT USE THIS APP. Call 911 or your local emergency services immediately.

1. NOT A MEDICAL DEVICE & NOT MEDICAL ADVICE: This application is not a medical device and does not diagnose, treat, cure, or prevent any medical condition. This app is a data collection and transmission tool only. It does NOT provide medical advice, independent diagnostics, or treatment plans.

2. HARDWARE ACCURACY: Readings are dependent on the calibration and proper use of third-party Bluetooth hardware. Sync errors or Bluetooth interference may result in delayed or missing data.

3. NO DOCTOR-PATIENT RELATIONSHIP: Use of this app does not create a doctor-patient relationship between you and the app developers.

4. CONSULT YOUR PHYSICIAN: Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on or transmitted through this app. Users must always seek a doctor’s advice in addition to using this app and before making any medical decisions.

Note for Reviewers:
This application is a clinical tool with a staff-mediated configuration model. Initial setup requires a physical A&D device. To review administrative gates and clinical threshold settings, tap 'Staff Setup' on the menu and enter the review PIN: 6789. For a full demonstration of the BLE data capture pipeline and data transmission, please refer to the secure demonstration video link provided in our app access instructions.

1. Regulatory Clearance Documentation:
Blood Pressure Integration: Below is the link to the official FDA 510(k) Premarket Notification document for the integrated A&D UA-651BLE blood pressure monitor under clearance number K141160.

https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141160.pdf

Pulse Oximeter Integration: The integrated A&D UP-200BLE Pulse Oximeter is regulated by the US FDA as a Class II Exempt medical device under Product Code DQA (Regulation 21 CFR 870.2700). Because it is classified as Exempt, the federal government does not issue an individual 510(k) clearance document. It is manufactured under strict ISO 13485 medical quality standards and is fully commercialized for clinical remote monitoring data tracking.