Intended use

Intended use:

OTH is a software platform consisting of two integrated parts, a web application and a mobile device application. The software platform is intended to provide patient information from the patient to a remote healthcare team through relevant network technology.

OTH is intended for booking and management of appointments, patient interaction through video consultation and text messaging, capture of electronic questionnaires, aggregation, storage and management of clinical data, as well as information management of independent external physiological measurement devices connected either directly to the mobile device application or through digital communication technologies such as USB, Bluetooth or Bluetooth Low Energy (BLE).

Product claims:

The OTH software platform allows HCPs (Health care professionals) to remotely monitor patients' vital signs (blood pressure, pulse, body weight, and SpO2) through questionnaires and/or forms requesting the patient to report on their health status and/or perform measurements. This combination of objective data and subjective responses enables HCPs to make informed, timely decisions for patients diagnosed with COPD (chronic obstructive pulmonary disease), CHF (congestive heart failure) or HTN (hypertension).

OTH enables the healthcare professional to design and distribute individualized or generic electronic questionnaires and/or forms. The healthcare professional may add threshold values for reference when reviewing reported information in the web application.

Indication for Use:

OTH version 2 is indicated for use by patients and by healthcare professionals for collecting and reviewing data from patients who are capable and willing to engage in the use of OTH.