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510(k) Data Aggregation
K Number
K030943Device Name
MODIFICATION TO HIOX
Manufacturer
SENSOR MEDICS CORP.
Date Cleared
2003-04-22
(27 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
SENSOR MEDICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.
Device Description
The Hi-Ox® is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 lpm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's. Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation. The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1.5 cmH,O, typically ~ 1.07 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve's resistance is specified to be less than 3 cmH2O/I/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.
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