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LARYNGOSCOPE FO (fibreoptic) + 7 blades

https://unicat.msf.org/cat/product/53891
STD EANELARY7--

Valid Article

Former Code(s): EANEZFR0162
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.
Z12021003 - Laryngoscopes
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
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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FIBREOPTIC LARYNGOSCOPE + 7 blades

Definition

A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal tube prior to the delivery of inhalation anaesthesia and/or ventilation.

It has a handle containing batteries to power its fibreoptic light for airway illumination, and a curved or straight blade of various lengths that can be hinged/interchanged.

Specifications

Quality standards

ISO 7376, 2020, edition 3, Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

Technical specifications

Rigid case including 2 handles and 7 blades

HANDLE

  • 2 sizes:
    • 1 handle diameter 28 mm
    • 1 handle diameter 19 mm, for better ergonomy while using small blades
  • chromium-plated brass or stainless steel
  • hollow and cylindrical
  • the handle of 28 mm is fitted for 2 x R14 batteries 1.5V, the handle of 19 mm for 2 x AA batteries, alcaline, 1.5V
  • fitted with a bulb, 2.5 V which switches on when the handle and the blade are connected
  • end with contact pads fitting the various blades
  • with green coloured ring, normalised (FO)

BLADES

  • stainless steel
  • fibre optic = FO (transmitting the light to the tip of the blade)
  • 6 curved Macintosh blades FO:
    • 1 x nº 0, total length 80 mm (± 5 mm): for infants from 6 to 12 months
    • 1 x nº 1, total length 90 mm (± 5 mm): for toddlers from 1 to 2 years
    • 1 x nº 2, total length 110 mm (± 5 mm): for children from 2 to 10 years
    • 2 x nº 3, total length 130 mm (± 5 mm): for children > 10 years and small adults
    • 1 x nº 4, total lenght 150 mm (± 5 mm): for tall adults
  • 1 straight Miller blade, nº 0, total length 78 mm (± 5 mm): for new-borns and infants up to 6 months

Supplied with the Article

  • 2 x R14 batteries 1.5 V or 2 x AA batteries, alcaline, 1,5V
  • 5 x spare-bulbs (only 1 spare if LED)

Instructions for use

Image

Precautions for Use

To prevent batteries from deteriorating, it is recommended to remove them from the handle when the instrument is unused for a prolonged period or stored under damp conditions.

Maintenance

After each use:

  • The blades must be cleaned, pre-disinfected and sterilized by steam autoclave (caution, repeated sterilization decreases the quality of the light transmitted by the fibres).
  • The handle must be cleaned and disinfected. Use a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix the with other products. Make sure to wet surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

This laryngoscope forms part of the emergency anaesthesia equipment and must always be present and kept ready for use in all hospital settings.

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