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The CareStation CS126S is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse rate, blood pressure, temperature, blood glucose, weight, and breath peak flow measurements. The information is collected upon the request and direction of the health care provider. The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgment and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareStation 126S Videophone system is a standalone videophone system that is equipped with the capability to transmit and receive data from a variety of external vital signs and medical measurement devices. The CareStation 126S also includes an integrated electronic digital stethoscope that provides for both local and remote auscultation functions and an optional accessory plug-in pulse oximetry sensor unit. Typically, the CareStation is deployed in a patient's home and another CareStation is installed in a healthcare provider or caregiver's office. Each is connected to a standard telephone network connection and the two systems communicate with each other through internal modems and transmit real-time video, audio, and data between them. The realtime video and audio communications allow the patient and caregiver to view and speak with each other. Using a supplied stethoscope transducer attached to the patient's system, heart, breath, and bowel sounds may be transmitted to the caregiver's system where they may be listened to using a set of stethoscope earphones that are supplied with the system. With existing legally marketed vital signs measurement devices attached to the patient's system, the caregiver may monitor the patient's blood pressure, pulse rate, temperature, weight, blood oxygen saturation, blood glucose level, breath peak flow, and transmit this data to the caregiver's system. Vital signs measurement devices used with the CareStation system are FDA approved devices and are used for the same purposes for which they received 510(K) approval or are devices that are exempt under applicable 21 CFR sections. The data may be captured, displayed, and/or saved on a computer using one or more of a variety of software packages including CareStation for Windows™. The CareStation may be configured for use with one to three external devices