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MASK LARYNGEAL, reusable, size 4

https://unicat.msf.org/cat/product/12523
STD EANEMALA04-

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.
R01020101 - Laryngeal masks, single-lumen
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
M
The order of this product needs to be justified and is only acceptable under certain conditions.
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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MASK LARYNGEAL

Definition

A curved tube used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients.

It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring.

Synonym

LMA (Laryngeal Mask Airway)

Specifications

Quality standards

  • ISO 11712, 2009, edition 1, Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
  • ISO 18190, 2016, edition 1, Anaesthetic and respiratory equipment - General requirements for airways and related equipment

Technical specifications

Single piece moulded device, latex free

  • Mask
    • Ovoid, silicone, semi-rigid portion intended to be inserted into the pharynx
    • inflatable peripheral cuff allowing to guarantee airtight seal over the glottic opening. Maximum pressure inside the cuff: 60 mm H2O
  • Tube connected to the mask:
    • translucent silicone
    • curve that is similar to the one of a tracheal tube
    • ended by a 15 mm connector allowing to fit on an Ambu® valve (and filter)
  • Separate inflation line with valve and inflation pilot balloon allowing to inflate the cuff
  • Autoclavable up to 134ºC
  • Non sterile, reusable
  • Sizes: see table below

Instructions for use

The laryngeal mask must always be used with an antiviral/antibacterial filter (see related articles below).

One unit of each size must be available in every structure having intubation equipment.

Precautions for Use

Some anaesthetic agents available within MSF, like ketamine, contraindicate this use.

Maintenance

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

(Cf Introduction: Disinfection and sterilization in the field)

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Extra Tables

# 2

# 2 1/2

# 3

# 4

# 5

Weight / poids patient

10 – 20 kg

20 – 30 kg

30 – 50 kg

50 – 70 kg

70 – 100 kg

Max volume LMA cuff / bourrelet

10 ml

14 ml

20 ml

30 ml

40 ml

Min. intern. Ø tube

8.6 mm

8.5 mm

8.5 mm

9.6 mm

10.6 mm

Max. extern. Ø tube

15 mm

17.5 mm

17.5 mm

20 mm

22.5 mm

Tube intern. length / longueur

13.8 cm

15.9 cm

15.9 cm

17.8 cm

20.0 cm

Intern. Ventilation volume

11 ml

15 ml

16 ml

21 ml

30 ml

Weight / poids

24.6 g

33.9 g

38.3 g

53.2 g

73.0 g