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CONCENTRATOR O2 (DeVilbiss 1025KS) 10l, 220V + access.

https://unicat.msf.org/cat/product/79921
STD EEMDCONE12-

Valid Article

Former Code(s): EEMDZBD0001
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 (DeVilbiss 1025KS) 10l

The model 1025KS replaces the New Life Intensity oxygen concentrator

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.

Synonym

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

  • 1 concentrator 1025KS
  • 5 outflow connectors HU-2555S
  • 1 user's manual
  • 5 long term filters 1025D-605
  • 1 set of 6 dust filters 303DZ-605
  • 2 antibacterial filters PV5LD-651

Technical specifications

  • Oxygen concentration: >90 % ± 3 % with a flow rate of 10 litres/min
  • Pressure of oxygen output: 20.0 +/- 1.0 psi (138 kPA +/- 7kPA
  • User interface
    • easy to operate
    • numbers and displays clearly visible and easily readable in low ambient light and sunlight
    • Digital or analogue meter that displays cumulative hours of device operation
  • Oxygen outlet with 6 mm (1/4 inch) barbed fitting or equivalent
  • Flowmeter displaying flowrate
    • minimum flow rate of 0.5 l/min or less
    • adjustable, within minimum gradation intervals of 1 l/min
  • Noise level < 60 dB(A).
  • Capable to be disinfected with hospital grade detergents
  • Fluid spill resistance: IP21
  • Circuit breaker for re-establishing the current following a power surge
  • Power switch
  • Power supply:3
    • Voltage 220-230 V AC, 50 Hz, 3.2Amp
    • Input voltage tolerance: 187-255 V
    • Average consumption: 670 W
  • Operating conditions
    • temperature from 10–40°C
    • relative humidity from 15–85% (preferably up to 95%)
  • Movable with wheels on at least two castors

3-level alarm system

  • Sound alarm + flashing light "service required" in case of power failure
  • Sound alarm in case the oxygen pressure is below the average (i.e. bended tube, flowmeter < 1 litre/minute or > 5 litres/minute)
  • OSD system = continuous monitoring of O2 concentration:
    • Green light => concentration > 85 %
    • Yellow light => concentration < 85 % (± 2 %)
    • Yellow light + sound alarm => concentration < 75 %

Protection against electric shock

  • Class II double insulation
  • Type B

Dimensions

  • Dimensions: 62.2 x 34.2 x 30.4 cm
  • Weight: 19 kg

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

Caution, the spare-parts of the different models of De Vilbiss are not always interchangeable!

Instructions for use

Before use, read carefully the user's and maintenance manual (supplied with the concentrator), and the “Respiratory therapy” chapter in the Manual of nursing care procedures, MSF, 2020.

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. 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 (paediatric distributor Sureflow) HUMIDIFIERS KIT (EEMDCONA007) which contains all the necessary accessories.

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Precautions for Use

  • Place the concentrator in a well ventilated area, at least 20 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.

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.

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 equipment page) .

MSF requirements

Article to replace the New Life Intensity concentrator because of frequent break-downs, expensive spare-parts.

The DeVilbiss is a more reliable apparatus, simple to maintain, with a reactive technical support from the manufacturer.

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SPARE-PARTS

The accessories or spare parts of the different models are not always interchangeables!

Check your concentrator model (at the back of the machine) before ordering spare parts!

The model for which a spare part is intended always appears in the label of the article (525KS and/or 1025KS)