(236 days)
The LiDCOrapid V2 Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
- The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
- When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation
Locations of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the LiDCOrapid V2 Monitor, which outlines its indications for use and regulatory classification. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).