Intended Use

CareSimple® is intended for non-continuous, mobile and multi-parameter physiologic patient monitoring. Patients using CareSimple® report quantitative and qualitative parameters from the following electronic input methods:

• Manual entries;
• Questionnaires;
• Wireless patient medical devices;
• Messaging, audio and video communications.

CareSimple® is intended to provide information which is used to support decisions with diagnosis or therapeutic purposes by the Health Care Professional (HCP), but not as the only means to aid in the diagnosis or treatment of a patient. 

CareSimple® retrospectively displays the data, user-defined data alerts and system alerts to the HCP. CareSimple® also allows the patient to review their data.

CareSimple® is not intended to make a diagnosis. CareSimple® does not replace the exercise of the knowledge, skills or judgment of any HCP and more particularly, does not replace a diagnostic decision made by an HCP. HCPs using CareSimple® are expected to be using it in conjunction with other sources of patient information to support diagnosis or treatment including but not limited to electronic health records or claims history. 

CareSimple® is not intended for emergency use or real-time monitoring. CareSimple® is not an emergency medical response system.