Pulse Co-oximeter

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Masimo Australia Pty Ltd

classe:

Class IIb

Fabriqué par:

Masimo Corporation 52 Discovery, Irvine, CA, 92618 United States Of America

Domaine thérapeutique:

46201 - Pulse Co-oximeter

indications thérapeutiques:

The device is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation, methemoglobin saturation, total haemoglobin concentration, and/or respiratory rate.; and is indicated for use with adult, paediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments. The device has an additional mode to provide clinicians with a guided tool to help screen newborns for Critical Congenital Heart Disease (CCHD) per the established CCHD Screening protocol.

Statut de autorisation:

A

Date de l'autorisation:

2008-12-03