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OXYGEN GENERATOR (Nidek MAX 30) 30L 230V/50Hz

https://unicat.msf.org/cat/product/80882
NST EEMDCONE18-

Valid Article

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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OXYGEN GENERATOR (Nidek MAX 30) 30l

Definition

The device is intended to supply supplemental oxygen to persons requiring oxygen therapy. It products oxygen by concentrating the oxygen contained in room air. It
can be used to administer oxygen with nasal cannulas or another type of device. It is possible to connect several Nidek in order to increase the oxygen flow production

Specifications

Performance

  • Oxygen Volume/Pressure: 63 SCFH @ 50 psi or 30 LPM @ 3.4 bar
  • Oxygen Purity: 93% (± 3%)
  • Oxygen Dew point: - 60°F or -51°C
  • Feed Air Requirement: None, compressors included
  • Response Time: Approximately 5 minutes to attain maximum purity after initial start-up or extended shut-down, or longer if a supplemental tank is used.

Physical

  • Oxygen Outlet Fitting: 1/8" NPT Male Insert
  • Sound Levels: 60 dBA @ 1 m
  • Dimensions: 24 x 21 x 44 in (W x D x H) or 610 x 530 x 1120 mm (W x D x H)
  • Weight: 200 lb or 91 kg
  • Power Requirement: Standard (International) 230 VAC, 50/60 Hz, Single Phase, 11 A
  • Oxygen Flow Rate: 63 SCFH or 30LPM
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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
  • Power cable
Image

Technical specifications

  • Oxygen concentration at 93% (+/- 3%) at 30 LPM
  • Pressure of oxygen output: 3,4 bar​ - 50 PSIG
  • Colour HD touch screen 4.5"
  • Output: 2 to 30 litres/min
  • Adjustable flow rate up to two outlets: 1 to 15 LPM each
  • Oxygen outlet: NF, BS, DIN
  • Power switch
  • Power supply: 230 V - 50/60 Hz / 11A
  • Average power: 2100 Watts
  • Noise level within ISO 80601-2-69:2014 guidelines
  • On both sides and back: three cabinet inlet air filters
  • At the compressor input: 3 inlet air filters
  • Before the oxygen outlet: a final product filter < 3µm
  • Multiple tube-axial fans (x10) cool the compressor compartment and the heat exchanger coils.
  • Mobile: on wheels Ø 65 mm
  • operating conditions:
    • temperature between 10°C and 40°C
    • relative humidity between 15% and 95% non condensing

Dimensions

Volume D x W x H/ 530 x 610 x 1120 mm
Weight: 113 kg

Supplied with the Article

  • 1 user's and maintenance manual
  • 1 technical manual

Instructions for use

Oxygen Generator for

  • Respirateurs d'anesthésie / OTs
  • Respirateurs de réanimation / ICUs
  • Oxygénothérapie
  • Systèmes de remplissage de bouteilles

Power supply

The generators 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.

Precautions for Use

  • Place the generator in a well ventilated area, at least 30 cm away from walls or any other object that might prevent free air flow.
  • Protect the generator 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

  • Wash the three cabinet air filters every two weeks or 20h.
  • The compressor air filter element should be replaced every 6 months or more frequently in dusty envir
  • Check oxygen concentration every 15,000 hours or 3 years to verify the continuous function. The low pressure compressor should be rebuilt after 15000h of operation. The booster compressor should be rebuilt after 6000h of operation.

MSF requirements

Mobile O2 station producing 30LPM, use in projects requiring high flow oxygen

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Description approved by OCB referent (Jonathan Delchambre) in September 2021.