超音波、心電図、動脈硬化指標など統合システム化

超音波、心電図、動脈硬化指標など統合システム化

ワイヤレス 携帯 連続 動脈硬化指標

2017年5月12日金曜日

ケアテイカ

Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Dated: February 16, 2016 Received: February 17, 2016 CareTaker Wireless Vital Signs Monitor Indications for Use (Describe) 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 Trade Name: CareTaker Wireless Vital Signs Monitor Common Name: CareTaker Continuous Non‐Invasive Blood Pressure Monitor Device Description: _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”) Intended Use: 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. Device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical setting. 8) Comparison to Predicate: Both the CareTaker and the NextFin predicate device are continuous non‐invasive blood pressure and heart rate monitors that derive these physiological parameters from the arterial pulse collected by a finger cuff. The devices are characterized by the following common features and differences:

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