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INCENTIVE SPIROMETER, portable, single patient, adult

https://unicat.msf.org/cat/product/54101
STD EPHYSPIR1A-

Valid Article

Former Code(s): EPHYZFR0077 EPHYZBE0023
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.
Z121501 - Spirometry instruments
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.
I measuring function
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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INCENTIVE SPIROMETER

Definition

A portable mechanical breathing-muscle exerciser used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing.

It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of air which can be inspired.

Specifications

Image

Quality standards

EN ISO 26782, 2009, (confirmed 2020) Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans

Technical specifications

  • Plastic bottle/container, latex-free
  • Minimum volume/capacity:
    • adult: 4 litres
    • child/elderly person: 2.5 litres
  • Flexible tubing connected to the container
  • Mouth piece at distal end of tubing
  • One-way valve to ensure that patients inhale, rather than exhale into the unit
  • Colored highly visible and moveable piston
  • Universal graphical graduation (indicating correct inspiratory flow rate)
  • External adjustable inspiratory indicator attached to the container
  • Single Patient Use

Instructions for use

The patient must breathe in slowly and as deeply as possible.

MSF requirements

Rehabilitation item used in all types of contexts.

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