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SPACER, single patient, medium mask

https://unicat.msf.org/cat/product/50787
STD SMSUSPAC4M-

Valid Article

Former Code(s): EMEQZBE0092 EMEQSPAC402 EMEQSPAC4M-
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.
R900901 - Inhalers
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
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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SPACER, single patient

Definition

Medicine chamber spacer for single-patient use

A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. By holding the drug after aerosolization this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway.

Specifications

Technical specifications

  • inhalation chamber washable
  • mouthpiece with valve
  • facemask in silicone: small or medium
  • for single patient use

Packaging & Labelling

Single piece, with 1 face mask included.

Instructions for use

Can be used with or without mask

After spraying medication into the chamber the patient may take the dose either by taking a single deep inhalation or by taking multiple shallow inhalations (tidal breathing). The medication will remain as a cloud for about 10 seconds, so inhalation should follow spraying fairly promptly.

With normal daily use the spacer will last about 12 months, after which it should be replaced.

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Precautions for Use

  • Clean the spacer and the mask at least once a week according to the manufactures instructions.
  • Store the spacer in a clean dry place.

MSF requirements

Cheap spacer, that can be given to the patient when discharged from the hospital.

For a hospital use, where the spacer can be used for several patients, there is a reusable spacer available (see related articles).

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