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SPACER, 155 ml, + silicone masks size1 & size2 + mouthpiece

https://unicat.msf.org/cat/product/13648
STD EMEQSPAC2--

Valid Article

Former Code(s): -X
Article is intended to be used with children (<12 years) ONLY.
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

Definition

Container that is placed between the metered-dose inhaler and the asthmatic patient's mouth in order to make delivery of inhaled medication easier and to improve the treatment effectiveness, particularly in young children.

Specifications

Technical specifications

  • Antistatic inhalation chamber
  • Volume: 155 ml, for paediatric use
  • Plastic mouthpiece with inspiratory and expiratory valve
  • All materals are latex-free
  • Connecting ring with opening for the mouthpiece of the metered dose inhaler (pre-fitted to the inhalation chamber)

Supplied with the Article

Each spacer is supplied with 2 paediatric masks (one of each size):

  • size 1 for children from 0 to 1 year (silicone)
  • size 2 for children from 1 to 4 years (silicone)

Instructions for use

  • For children under 4 years, use the mask.
  • For children over 4 years, inhalation can be done directly with the mouthpiece.
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Maintenance

  • The spacer and masks must be cleaned and disinfected before every change in patients. If it is not sterilised afterwards, the mouthpiece must also be replaced.
  • Dismantle and sterilise the spacer and masks according to the manufacturers instructions
  • If single patient use: clean the chamber, the mouthpiece and the connecting ring in boiling soapy water at least once a week.
  • The spacer can be cleaned, disinfected and sterilised for re-use in the hospital up to 30 times as described. After that, it must be replaced.
  • The spacer should be replaced at least once a year.

(Cf Introduction: Disinfection and sterilization in the field)

Storage

After disinfection or sterilisation, store the spacer in a dry, dust-free place.

MSF requirements

The reusable spacer is intended for hospital use and it can be used for several patients.

A cheaper single patient spacer is also available and can be given to the patient when discharged from the hospital.

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