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TRACHEOSTOMY TUBE, cuffed, int.tube, ster., ID 5.0mm

https://unicat.msf.org/cat/product/18387
STD SCTDTUBT04C

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single patient multiple use A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
R0105020101 - Tracheostomic cannulas, cuffed, not reinforced, with fixed flange, and kits
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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TRACHEOSTOMY TUBE, cuffed

Definition

A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea during a tracheotomy to provide a patent airway. It is constructed of plastic and includes an inner cannula. It is cuffed and non-fenestrated. It is secured in position by a tracheostomy tube holder fastened around the patient's neck.

Specifications

Quality standards

  • ISO 5366, 2016, edition 1, Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
  • EN 1282-2, 2009, Tracheostomy tubes - Part 2: Paediatric tubes, edition: 3

Technical specifications

  • Cannula:
    • PVC, silicone
    • 90º angled tube with balloon
    • non-fenestrated
    • open, atraumatic distal end
    • proximal end with male conical connector, Ø15 mm
    • collar which fits the patient's neck
    • radio-opaque
  • Tracheal balloon:
    • PVC, etc.
    • located near the distal end of the cannula
    • low pressure
    • connected to an inflating duct:
      • included in the wall of the tube
      • ending in a non-return valve with Luer connection
      • with indicator balloon indicating inflation status of the balloon
  • Inner cannula:
    • removable while leaving the cannula in situ
    • proximal end with standard connector, 15 mm Ø for connecting to the ventilation system (by rotation or clip / click system)
    • reusable after cleaning it thoroughly
  • Guide for insertion
  • Fixing strip
  • Sterile device, for single patient use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Choosing the appropriate inner and outer diameter sizes of the tracheostomy tube are important when recommending the initial tracheostomy tube size or tracheostomy tube changes.

A tracheostomy tube from one manufacturer may not correspond to the same size from a different manufacturer as they may have different internal/external diameters or length. Different manufacturers follow different sizing guidelines: some tracheostomy tubes utilise the Jackson sizing system, while other tubes use the ISO method.

The appropriate dimensions are listed on the flange of the tracheostomy tube.

ISO requires that tracheostomy tubes are sized according to the narrowest part of the inner diameter which includes the inner cannula. The outer cannula is measured as the largest diameter of the outer cannula.

Size

Inner Ø

Outer Ø

length

Use for

4

5.0 mm

9.4 mm

60 - 65 mm

Child

6

6.4 mm

10.8 mm

70 - 76 mm

Adolescent

Adult woman

8

7.6 mm

12.2 mm

70 - 82 mm

Adult man

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