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RESUSCITATOR MANUAL (Ambu), child + masks RH2/S1

https://unicat.msf.org/cat/product/12547
STD EANERESU2CN

Valid Article

Former Code(s): EANESIBS1CN
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.
R03020201 - Manually operated pulmonary resuscitators
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
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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RESUSCITATOR child (Ambu)

Definition

A hand-operated device designed to provide or assist ventilation in children who are apnoeic or exhibit inadequate respiration. It employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal tube; oxygen may also be connected when necessary.

It is used by emergency medical services in ambulances, intensive care units, during internal patient transfer, accident and emergency, mass casualty incidents, and is generally placed strategically throughout a hospital.

Specifications

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Quality standards

ISO 10651-4, 2023, edition 2, Lung ventilators - Part 4: Particular requirements for user-powered resuscitators

Technical specifications

  • SELF-INFLATING BAG
    • self-inflating and compressible balloon in transparent silicone
    • maximum bag volume: 635 ml
    • maximum stroke volume: 450 ml
    • air intake valve
    • patient valve connection
    • fitted with a handle allowing the use with one hand only and regular inflations
    • autoclavable 30x
  • PEDIATRIC PATIENT VALVE
    • non rebreathing device, one-way, with unique valve inlet
    • translucent polysulphone
    • fitted with a pressure limiting valve with pop-off cap (40 cm H2O)
    • patient connector ISO 22/15 mm
    • male respiratory connector ISO 30 mm, female respiratory connector ISO 24 mm
    • dead space < 6 ml
    • inspiratory resistance at 5 l/min: < or = to - 5 cm of H2O
    • expiratory resistance at 5 l/min: < or = to 5 cm of H2O
    • silicone valve inlet (different than the red adult valve inlet)
  • MASK nº RH2
    • transparent polysulphone shell
    • silicone rubber blue rim
    • fitted with metal hookring
    • adjustable on 22/15 mm connections
  • MASK nº S1
    • transparent silicone
    • adjustable on 22/15 mm connections
  • OXYGEN RESERVOIR BAG
  • Easy to disassemble for cleaning
  • All components are autoclavable up to 134ºC
  • Latex free
  • Non sterile

Instructions for use

Forms part of the emergency resuscitation equipment. Should always be kept ready for use: visible, clean, complete and in good working order.

Should only be used by experienced staff.

The use of the oxygen reservoir bag is recommended if oxygen is available, as it enables to enrich the inspired gas with oxygen.

Precautions for Use

The patient valve is different for the adult/child self-inflating bag and the child self-inflating bag. The childself-inflating bag must be used with the "paediatric" patient valve (see related articles below).

Never obstruct the pressure relief valve, unless medically indicated. High pressures can cause pulmonary lesions.

Maintenance

Before use:

  • Check that the valve outlet operates correctly (it should not stick), by gently breathing through the valve whilst watching the flap move.
  • Check the elasticity of the bag by manual pressure.

After each use:

  • The patient valve and the masks must be pre-disinfected, cleaned and sterilized by steam autoclave

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

Device used for manual ventilation assistance in children with weight between 10 and 30 kg, in case of respiratory distress or failure.

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