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ENDOTRACHEAL CLOSED SUCTION SYST. 72h, CH14, 3720001

https://unicat.msf.org/cat/product/80393
STD SCTDTUSC14E1

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 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).
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.
R050102 - Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
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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ENDOTRACHEAL CLOSED SUCTION SYSTEM

Definition

Closed suction system for tracheal aspiration, on an adult patient, intubated and artificially ventilated in ICU.

A flexible tube typically made of plastic designed for periodic aspiration of liquids and/or semi-solids from a patient's upper airway. The tube is usually 40 to 56 cm in length and of small enough diameter to fit through an endotracheal (ET) tube. It usually has a smooth and rounded distal-tip configuration, including end and side holes; most include a finger-controlled valve to regulate the suctioning pressure. The device is externally attached through a large-diameter extension tube to a vacuum system and collection jar; it is used to remove excessive internal secretions from the lungs, bronchi, trachea, and pharynx. This is a single-use device.

Specifications

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Quality standards

ISO 8836, 2019, edition 5, Suction catheters for use in the respiratory tract

Technical specifications

  • Suction catheter
    • CH 14 = external Ø 4.7 mm
    • length: 537 mm
    • length scale
    • improved sheathing: transparent, resistant and silent
  • Distal end
    • Instillation port with integral cap
    • Flexible tip catheter with Murphy's eye
    • Isolation valve
    • Double ball connection
  • Proximal end
    • Ergonomic suction valve
      • allows control of the suction force
      • Locking system to prevent unwanted activation
    • Disconnection tool
    • Standard colour code: green
  • Sterile, à usage unique

Packaging & Labelling

Each catheter is packed in a disposable peel pack allowing safe handling, and storage until needed for use and facilitating proper aseptic presentation.

Box of 15 units.

(Cf Introduction: Packaging and labelling)

Instructions for use

Storage

  • Store in a clean, dry place.
  • Avoid direct sunlight
  • Temperature between -20°C and +50°C.

MSF requirements

For patients

  • Being ventilated for more than 24 hours AND
  • having acute respiratory distress syndrome OR hypoxia requiring high level of PEEP (≥10cmH2O)

Closed suction system prevents deconnection and subsequent episodes of desaturation in hypoxic patients and limits ventilator associated pneumonia

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