Application Specification

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Product Requirements

Intended Use

The My GrandCare Monitoring System Product Family is a communication tool that collects vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The system allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients. Caregivers can be notified when readings have been taken or not taken. The system also can be used to remind patients when it is time to take medication, provide information about the medication as entered by caregivers, and to notify caregivers when medication has been taken or not taken.

The system can also collect information from commercially available activity of daily living sensors, such as motion, door, bed and temperature sensors, caller ID modems, and action buttons, which can be reviewed by caregivers, and which can trigger rule-based notifications to caregivers.

Indications for Use

The My GrandCare Monitoring System product family is intended to collect vital sign measurements from commercially available physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the, caregivers' questions by participating in surveys. The My GrandCare Monitoring System Product Family allows the caregiver to review patient data, receive notifications when readings have been taken or not taken, or fall outside a caregiver-defined range, and initiate video conferencing with patients, or select and send educational and motivational content to patients. The system also serves as a medication management system for the patient and caregiver.

How Used

The system collects measurements captured on commercially available personal computers, from commercially available wireless medical devices which are designed for home and assisted living center use, and displays the information on the computer screen for the patient, and through an Internet interface for the caregiver. The system can provide alerts to caregivers when health readings have been taken or not taken, or fall outside a caregiver-defined range, or when medication has been accessed or not accessed. It can provide prompts to patients when it is time to taken medications, and information about the medication. The system provides multiple choice-style health assessments for the patient, and then delivers the results to caregivers.

Intended User(s)

Clinical users are assisted living-based caregivers, or adult children, grandchildren of home-based patients. End users are home-based elderly patients or assisted living-based elderly patients. Additional users include installers, distributors, purchasing agents and the environment.

Intended Use Environment(s)

Homes and assisted living centers.

Targeted Patient Populations

Elderly patients living at home, or assisted living-based elderly patients.

Contraindications

The My GrandCare Monitoring System product family is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is not intended to be used as a personal emergency response system (PERS). It is made available to patients when time-critical care is not required. The My GrandCare Monitoring System product family is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

GC-01-OUM-0043 Rev A

pdf format (Media:ProductRequirements.pdf)