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FILTER, BREATHING CIRCUIT, 15M/15F, neonate, s.u.

https://unicat.msf.org/cat/product/18277
STD SCTDBRCF1N-

Valid Article

Former Code(s): -X
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.
R040101 - Antibacterial and antiviral respiratory filters
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

Definition

A non-sterile device intended to remove/filter microorganismsfrom air to prevent patient exposure during respiration and anaesthesia.

It is a small plastic housing containing a filter which will typically also filter other particulates.

Intended for:

  • SCTDBRCF1A--: adults and children over 15 kg
  • SCTDBRCF1N-: neonates and children below 15 kg

Synonym

BSF: breathing system filter

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)
  • dead space:
    • SCTDBRCF1A--: < 40 ml
    • SCTDBRCF1N--: < 18 ml

FILTER

  • 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 %

​STANDARD CONNECTIONS

SCTDBRCF1A-

SCTDBRCF1N-

Patient side

15F / 22M

15F / 8.5 F

Breathing circuit side

15M / 22F

15M

TIDAL VOLUME

  • SCTDBRCF1A--: > 150 ml
  • SCTDBRCF1N--: 25 – 100 ml maximum

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 24 hours, regardless of the form of ventilation (manual or mechanical).

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).

Routine use eliminates the need for sterilization of respiratory assistance equipment.

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