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HME FILTER, BREATHING CIRCUIT, 22M/15F, child, s.u.

https://unicat.msf.org/cat/product/70155
STD SCTDBRCF3C-

Valid Article

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).
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.
R040102 - Antibacterial and antiviral respiratory filters humidifiers
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
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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FILTER, BREATHING CIRCUIT + HME

Definition

A non-sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain micro-organisms whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the air / gases inspired by the patient.

It is a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract.

It is used during periods of prolonged respiratory support (ventilated patients in ICU).

Intended for

  • SCTDBRCF3A-: adults and children over 15 kg
  • SCTDBRCF3C-: children 10 - 15 kg

Synonym

HMEF

Specifications

Quality standards

  • ISO 23328-1, 2003, edition 1, (confirmed 2014) Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
  • ISO 23328-2, 2002, edition 1, Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects

Technical specifications

RIGID BOX: transparent plastic: enables visual inspection of secretions.

FILTER

  • transparent plastic (enables visual inspection of secretions)
  • dead space: < 40 ml
  • Type: mechanical filters usually consist of a sheet of densely packed glass fibers that have been resin-bonded. This sheet provides a high resistance to gas flow per unit area due to the dense packing of the fibers. To decrease the resistance to gas flow to an acceptable level, a glass fiber sheet with a large surface area is utilized. The sheet is pleated to maintain a large surface area in a smaller package, also reducing deadspace in the housing. The fiber sheet is hydrophobic, in an effort to minimize water absorption.
  • Efficiency:
    • 100 – penetration rate
    • penetration rate of NaCl particles: the more efficient a filter is, the lower the penetration rate will be
    • Bacterial and viral filtration efficiency: 99.999 %

HME = Heat and Moisture Exchange

Mechanism of HME: warming and humidification is regulated by the moisture content of the expired air and patient's core temperature

  • Housing contains a layer of foam or paper embedded with a hydroscopic salt such as calcium chloride
  • Expired air cools as it crosses the membrane, resulting in condensation
  • On inspiration absorbed heat evaporates the condensate and warms the air, the hygroscopic salt releases water molecules when the vapor pressure is low
  • Moisture output greater than 30 mg H2O/L

STANDARD CONNECTIONS: 22M/15F

TIDAL VOLUME:

  • adult: > 150 ml
  • child: 70 - 150 ml

OTHER SPECIFICATIONS

  • With or without capnograph port
  • Latex-free
  • Medically clean: moulded at very high temperature, manufactured and assembled in a clean environment
  • For single patient use

Packaging & Labelling

Unit packaging in peel-open pack

Instructions for use

The filter MUST be changed between each patient.

It may be used in an individual patient for a maximum of 72 hours but should be changed earlier if soiled.

The filter must be positioned as close as possible to the patient (between the facial mask or the intubation tube and the respiratory assistance device).

MSF requirements

To be used for ventilated patients in ICU.

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