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OXYGEN ANALYSER, 0-10 LPM 21%-95.6%

https://unicat.msf.org/cat/product/12669
STD EIMTCONE1--

Valid Article

Former Code(s): EHOECONC3AO EEMDCONE3AO
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.
Z1203020403 - Oxygen analysers
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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Documents

OXYGEN ANALYSER

Definition

The oxygen analyzer measures oxygen concentration and flow at the outlet of an oxygen concentrator using ultrasound technology and measures pressure using a silicon pressure sensor.

Specifications

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Quality standards

ISO 80601-2-55, 2018, edition 2, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Components

  • Oxygen analyzer
  • Soft cover
  • Tubing
  • 2 batteries AA
  • 1 manual

Technical specifications

  • From a single connection, the device controls all concentrators from 0 to 10 l/min:
    • Oxygen concentration (%) 21% -95.6% ± 1.5%
    • Flow rate (l/min) 0-10 l/min ± 0.2 l/min
    • The patient output pressure (KPa‌& psi) 0.5-50 PSI ± 0.5%
  • No calibration of the device is necessary, no measuring cell to change
  • Easy to use, 2 buttons only
  • Battery powered: 2 AA batteries (> 16000 readings)
  • The device turns off automatically in order to extend the life of the battery

Dimensions

  • +/- Thickness 2.6 cm; width 8 cm; length 13 cm
  • Weight: +/- 185 g

Packaging & Labelling

Unit package

Supplied with the Article

  • 1 x carry case
  • 1 x set single use batteries
  • 1 x certificate of calibration and inspection to be provided
  • 1 x user / maintenance manual

To be Ordered Separately

Connectors and/or adapters suitable for measurement of various medical gas supply sources, e.g. oxygen concentrators, ventilators/anaesthesia machines and patient circuits (T-piece and/or in-line adapters)

Instructions for use

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Precautions for Use

  • Do not use the apparatus for continuous oxygen monitoring.
  • Do not use the apparatus to measure the oxygen concentration of a concentrator when flowing at rates lower than its optimal performance as specified by the concentrator manufacturer. Generally 4 LPM or less on concentrators that have a maximum flow of 10 LPM ​, and 1 LPM or less on concentrators that have a maximum flow of 5 LPM
  • Do not autoclave or expose the apparatus to high temperatures (>60°C).
  • Not for use in anaesthesia applications or for measuring oxygen concentration from any sources other than conventional oxygen concentrators.
  • Not suitable for use in the presence of flammable anaesthetic mixtures. Danger of fire or explosion!
  • Do not use rechargeable batteries.
  • Do not use the apparatus ​to check a concentrator with a humidifier in place. Humidity from a humidifier could damage the device.

MSF requirements

Essential tool for the control and maintenance of an oxygen concentrator, providing fast and accurate information on its performance and good operation.

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