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MASK ANAESTHESIA + RIM + HOOK, size 4, adolescent

https://unicat.msf.org/cat/product/12526
STD EANEMASARH4

Valid Article

Former Code(s): -X
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.
R03010101 - Anaesthetic face masks
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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MASK ANAESTHESIA + RIM + HOOK

Definition

A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It includes a 22 mm connector and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator or an anaesthesia balloon for ventilation assistance.

Specifications

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Quality standards

  • ISO 5356-1, 2015, edition 4, (confirmed 2020) Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
  • ISO 18190, 2016, edition 1, Anaesthetic and respiratory equipment - General requirements for airways and related equipment

Technical specifications

  • Rigid moulded shell, made of neoprene or polysulphone. A transparent dome (optional) allows observation for vomitus, secretions, blood, lip colour and exhaled moisture and is better accepted by a conscious patient.
  • Green or blue silicone rubber rim:
    • flexible
    • the pressure of the rim (cuff) can be adjusted through a valve. A somewhat under-inflated rim achieves a better seal than a fully inflated one.
    • anti-leak
  • Silicone rubber connector, 22 mm diameter
  • Metal ring with hooks for fixing the headband
  • Each shell must be marked with a number corresponding to the size of the mask:
    • 2 for child
    • 4 for adolescent
    • 5 for adult
    • 6 for tall adult
  • Autoclavable
  • Non sterile, reusable

Instructions for use

  • The masks nº 2 (child) and nº 5 (adult) are supplied with the manual resuscitator for adult/child.
  • The mask nº 2 (child) is also supplied with the manual resuscitator for child/newborn child.
  • ​For infants, specific round all silicone masks are available.

Provide a sufficient quantity of masks in each size.

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Maintenance

Must be pre-disinfected, cleaned and sterilized by steam autoclave after each use.

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

Basic resuscitation equipment

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