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HEADBAND, for anaesthesia mask

https://unicat.msf.org/cat/product/12496
STD EANEBAND1--

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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.
R03010180 - Artificial ventilation masks - accessories
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
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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HEADBAND, for anaesthesia mask

Definition

A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration.

Specifications

Technical specifications

  • Antistatic rubber or silicone
  • Single piece moulded
  • Fenestred square + 4 straps with reinforced perforations
  • Firm, moderate elasticity
  • Adult size
    • Total length: 70 cm
    • Length of the straps: 30 cm
    • Width: 20 cm
    • Thickness: 2 mm
  • Autoclavable
  • Non sterile, reusable

Instructions for use

Reserved for experienced anaesthetists.

Attention, nothing must be allowed to interfere with correct observation of the patient (risk of vomiting, cyanosis etc.).

Maintenance

Use a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

(Cf Introduction: Disinfection and sterilization in the field)

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