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MASK ANAESTHESIA, silicone, size 0, premature infant

https://unicat.msf.org/cat/product/12529
STD EANEMASAS0-

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.
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
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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, silicone

Definition

A flexible, form-shaped device designed to be placed over a child'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 15 mm or a 22 mm connector.

This device is sometimes used in association with a manual resuscitator or an anaesthesia balloon for ventilation assistance in infants and small children.

Specifications

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

  • Round, flexible, moulded shell, made of transparent silicone
  • With open silicone cuff
  • Each shell is marked with a number or a size corresponding to age of the baby/child:
SizeNumberOuter diameter
PrematureS042 mm
NewbornM150 mm
InfantL260 mm
  • Mouth diameter:
    • 15 mm for size 0 (premature) and 1 (newborn) => fits inside the valve connection = male connection
    • 22 mm for size 2 (small child) => fits outside the valve connection = female connection
  • Autoclavable
  • Non sterile, reusable

Instructions for use

The all silicone mask nº 1 (newborn) is supplied with the self-inflating bag for child/newborn.

For children, adolescents and adults, specific masks with rim and hooks are available.

Provide a sufficient quantity of masks in each size.

Maintenance

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

  • Remove all connector adapters from the device. The devices must be reprocessed in a disassembled state, as far as possible.
  • Do a manual pre-cleaning, until the devices are visually clean. Submerge the devices in a cleaning solution. Clean the surfaces with a soft bristol brush.
  • Visual inspection for cleanliness of the products and reassembling,
  • Check that the product has no dents, cracks, deformations, scratches, etc.
  • Check all markings on the product for clear visibility.

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

Basic resuscitation equipment

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