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ARTIFICIAL AIRWAY MANOMETER/INFLATOR, Luer

https://unicat.msf.org/cat/product/75576
STD EANEAACM1--

Valid Article

Former Code(s): EMEQCUFF6-- EHOEZNL0322
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.
R01038001 - Endotracheal tube cuffs inflation systems
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 measuring function
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
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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ARTIFICIAL AIRWAY MANOMETER/INFLATOR

Definition

A device designed to measure the pressure and instill air into the (low pressure) cuff of an in situ endotracheal or endobronchial tube. The inflator includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.

Synonym

Cuff manometer, cuff pressure gauge

Specifications

  • Analog system with no dependence on any energy source
  • Rubber hand bulb for cuff inflation
  • Diameter of the dial = +/- 68 mm
  • The dial has two zones of measurement graded in cm H2O with colour coding (green = safe range)
  • Pressure release valve on the back for adjustment of the pressure
  • Hook on the back to aid storage (optional)
  • Luer connection: for connection to the tracheal or laryngeal tube allowing pressure measuring and regulation, either directly or via the connecting tube
  • Tubing with Luer connection: +/- 100 cm
  • Vacuum valve: for connection to the tracheal tube allowing a complete deflation of the cuff by squeezing the inflation bulb
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Quality standards

ISO 23371, 2022, edition 1, Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices

MSF requirements

Mechanical ventilation in intensive care (+ operating room)

Will be mentioned in the protocol “prevention of pneumonia acquired under mechanical ventilation” but simple use with direct reading of the “right” pressure on the manometer screen.

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