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The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements. the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that runs on the Caretaker platform to provide additional hemodynamic measures to the Caretaker Remote Display App And Caretaker Software Library, K181196, and CareTaker Physiological Monitor, (K211588, K163255, K151499). These parameters are not intended to predict or detect cardiovascular mortality or any other condition, disease, and/or patient outcome.

The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations. In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention. The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.

CareTaker Medical's App ("CareTaker Remote Display App") is a software App that runs on Commercial, Off the Shelf (CoTS) hardware to provide additional controls and features to the CareTaker4 Physiological Monitor, K163255, as well as an interface to other devices. The App is a software platform that displays and stores physiological parameters and waveforms from patient monitoring medical devices. CareTaker Remote Display App can also forward this data to third party systems, including Electronic Medical Records systems. The integrated CareTaker Software library provides new control and configuration functions to a connected CareTaker4 Physiological Monitor. This library can also be used by 3rd parties to develop their own Apps that are capable of controlling a CareTaker4 as well. The library does not and cannot control any other medical devices or systems it is connected with. CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.

CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP"), heart rate ("HR"), ould respiration rate ("RSP"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual method or any A MI 81060 compliant BP device, or is automatically calibration mode. All parameters derived by Care Taker are reported to an integrated LCD screen and optionally to a remote display monitor (RDDS) via standard radio transmission protocols. The device is intended for use by clinicians or other properly trained medical personnel and does not provide any physiological alarm functions.

CareTaker is a cardiovascular monitoring device that non-invasively measures continuous blood pressure, heart rate and respiration rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA"). CareTaker is calibrated using any manual or AAMI 81060 compliant blood pressure device or is automatically calibrated using its self-calibration mode.

CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP") and heart rate ("HR"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical settings.

CareTaker is a cardiovascular monitoring device that noninvasively measures continuous blood pressure and heart rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA")