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FACE MASK NIV, non-vented, complete, reusable, M

https://unicat.msf.org/cat/product/73736
STD EANEFAMA3CM

Valid Article

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.
R0301010202 - Niv masks
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
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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NIV FACE MASK, non-vented, reusable

Definition

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV).

It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap.

Specifications

(Respireo non vented mask)

  • a) mouth-and-nose cushion (rim)
  • b) main body
  • c) forehead support
  • d) forehead rest
  • e) adjusting knob
  • f) adjusting screw
  • g) cap
  • h) elbow
  • i) headgear
  • l) clip
Image

Technical specifications

  • Non-vented mask, covers nose and mouth
  • Standard female 22 mm tapered fitting for external connection to the ventilator
  • Rotating elbow, coloured blue to indicate the mask is non-vented for dual limb circuit
  • Physical dead space (= empty volume of the mask to the end of the swivel) : < 250 ml for the Large size
  • Therapy pressure 4 to 40 cm H2O
  • Does not contain latex, PVC or DEHP materials
  • Reusable: the mask can be autoclaved at 120°C

Packaging & Labelling

Unit packaging including instructions for use.

To be Ordered Separately

For the Respireo Hospital F mask: the headgear has to be replaced every 7 days and is single patient use. Spare headgears have to be ordered separately. (see accessories)

Instructions for use

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Precautions for Use

  • This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting.
  • The mask should not be worn unless the ventilator system is turned on and operating properly.
  • Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition.
  • Ensure the soft sleeves are fitted at all times during use.

Maintenance

Must be pre-disinfected, cleaned and sterilized by steam autoclave after each use.

Follow the manufacturer's instruction

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

Volume or pressure cycled ventilators such as the Monnal T60 or LTV 1200 are designed to function with a closed circuit (non-vented) and the exhalation valve on the machine releases the expired/exhaled gases, while the inspiration valve is closed.

Therefore if there is a leak in the system such as with a vented mask, the inspiration valve will not close and an alarm will trigger continuously.

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