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CPAP O-Two single use SET, mask n°3 child, + manometer

https://unicat.msf.org/cat/product/80526
STD SCTDCPAP202

Valid Article

Single patient multiple use A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
R02010401 - Cpap circuits
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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CPAP in line system o-two, with manometer

Definition

A system of devices intended to be integrated between a medical gas supply and a face mask/mouthpiece to assist noninvasive ventilation using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It is a small plastic unit intended to be used with a separate flowmeter and manometer to establish a gas pressure proportional to gas flow rate through turbulent gas flow in an internal chamber using accelerating micro-channels (a virtual valve); tubing is included.

Specifications

The o-two Single-Use “Open CPAP” Delivery System provides accurate CPAP delivery.

A Luer port is located on the device to attach a pressure gauge. The ambient air intake port and the location of the in-line oxygen hose are designed to eliminate the possibility of accidental occlusion (risk of barotrauma).

The adjustment of the CPAP level is achieved by adjusting the output flow from your oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting.

As this is an “Open” system, the device allows unrestricted inspiratory flows, since the patient has access to ambient air.

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Technical specifications

  • CPAP range: 5 – 25 cm H2O
  • Pressure gauge range: 0 - 20 cm H2O
  • Required therapy flow rate: 8 - 25 l / min
  • Weight with face mask and tubing: 0.1 kg
  • Input connection: oxygen therapy barb
  • Patient face mask connection: 22mm
  • Non sterile, single patient use

Packaging & Labelling

Each set is individually packed

Instructions for use

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Precautions for Use

The system is not adapted for neonates and infants.

MSF requirements

Respiratory support in emergency for respiratory failure, alternative to invasive mechanical ventilation

Added value:

  • light weight, portable
  • ability to generate CPAP with oxygen flow of less than 10L (can work on oxygen concentrator)

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