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CONCENTRATOR O2 (New Life Intensity) 10l, 230V, 50 Hz + acc.

https://unicat.msf.org/cat/product/53898
NST EEMDCONE5--

Valid Article

Former Code(s): EHOEZFR0664 EHOECONC5-- EHOEZNL0365 EHOEZBE1132
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.
Z12159004 - Oxygen concentrators
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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CONCENTRATOR O2 (New Life Intensity) 10l

Removed as MSF Standard in 2021 for several reasons and replaced by the DeVilbiss 1025 (see "replaced by" at bottom of the page)

Definition

​A stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, through an attached nasal cannula, to a patient requiring oxygen therapy. It consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location.

Specifications

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Quality standards

ISO 80601-2-69, 2020, edition 2, Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

Components

  • Casing with vertical layout + handle + 4 wheels
  • 2 filters (accessible thanks to the removable panel)
    • Foam pre-filter for large particles
    • Felt filter for fine dust particles and bacteria
  • Flowmeter adjustable from 1 to 10 litres/min
  • Standard connector nozzle at the O2 outflow (9/16)
  • Power cable

Technical specifications

  • Oxygen concentration (based on 21°C at sea level):
    • 2-9 litres/min: 92% +3.5 / -3%
    • 10 litres/min: 90% +5.5 / -3%
  • Ajustable flowrate from 2 to 10 litres/min
  • Oxygen outlet with connection for a humidifier if required
  • Pressure of oxygen output: 138 kPa
  • Accuracy: Flowmeter ± 10% or ± 200ml of indicated flow
  • Power switch
  • Circuit breaker reset button for re-establishing the current following a power surge
  • Power supply: 220-240 V AC, 50 Hz, 1.55Amp
  • Average consumption: 590 W
  • Sound: 55 dB
  • Response Time: 5 minutes to reach maximum oxygen concentration.

Dimensions

Volume D x W x H: 36.8 x 41.9 x 69.9 cm

Weight: 26 kg

Supplied with the Article

  • 1 user's and maintenance manual
  • 1 technical manual
  • 1 spare filters kit including:
    • 6 foam pre-filters
    • 5 dust felt filters
  • 5 reusable humidifiers

To be Ordered Separately

Don't forget to order the administration devices in sufficient quantities because they are single patient use!

  • oxygen masks for adults and children
  • nasal oxygen cannula for adults and children
  • nasal oxygen cannula for neo-nates and prematures
  • oxygen tubes
  • pediatric flow splitter Sureflow

See related articles at the end of the technical sheet

Instructions for use

Before use, read carefully the user's and maintenance manual (supplied with the concentrator).

Once the device is turned on, 15 min are necessary to get the maximum level of O2 concentration.

Use of the Airborne module

In case TB patients are suspected: order the Airborne module for the O2 concentrator (avoid cross-contamination)

Use of the humidifier (see separate technical sheet)

The humidification of oxygen is recommended in case of prolonged administration in order to prevent the mucous membranes to dry out.

But if the O2 administration is of short duration (few hours), it is better not to use a humidifier.

5 reusable humidifiers (EEMDCONA003) are supplied with the concentrator.

Use of the paediatric flow splitter 'Sureflow' (see separate technical sheet)

This flow-splitter (EEMDCONE007) is more expensive but more reliable than the previous one.

The paediatric flow splitter allows administering O2 to 2, 3 or 4 children simultaneously and to regulate exactly the flow rate for each child (see separate technical sheet). This should be used with nasal cannula's (nasal prongs) and monitored with a pulse oximeter.

To use humidifiers with this flow splitter you have to order male connectors to screw on the top of humidifiers. To have the same number of connectors as humidifiers to screw: order the HUMIDIFIERS SET (EEMDCONA007) which contains all the necessary accessories for the flow splitter

Power supply

The concentrators must work on a stabilized electric supply source.

In case of electric supply problems it is necessary to provide for assistance like a diesel type generator.

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Precautions for Use

  • Place the concentrator in a well ventilated area, at least 30 cm away from walls or any other object that might prevent free air flow.
  • Protect the concentrator from humidity.
  • Protect the O2 source from any flame or spark. Do not smoke nearby.
  • Do not to use grease on the connections.
  • Do not to use solvent (alcohol, petrol…) on the equipment.

Maintenance

The preventive maintenance is simple but must be rigorous (with maintenance logbook):

  • Regularly remove the dust from the casing (to unscrew)
  • Foam pre-filter:
    • clean twice a week
    • replace when damaged (minimum once a year)
  • Case filter: replace every 3 months (in a dusty environment, check every month)
  • Final anti-bacterial filter (inside of the concentrator): replace once a year
  • Humidifier: autoclave sterilization between each patient, change the water daily.

It is recommended to have one oxygen analyzer per mission (see related articles below) and one Biomed tool kit.

MSF requirements

Item selected in 2015 by the MSF anaesthetists in collaboration with the biomedical group.

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