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COLLAR, CERVICAL, paediatric, adjustable, s.p.

https://unicat.msf.org/cat/product/13600
STD EMEQCCOLPA1

Valid Article

Former Code(s): -X
Single patient multiple 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.
Y060312 - Cervical spine orthoses
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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COLLAR, CERVICAL, paediatric

Definition

A padded device that is worn around the neck and used to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae.

Specifications

Technical specifications

  • One single piece made of radiotransparent foam-lined polyethylene
  • Paediatric size
  • 12 different height adjustments
  • Fitted with 2 safety clips to hold the collar in place
  • Size: 447 x 188 x 14 mm
  • Weight: 100 g

Packaging & Labelling

Packaged flat with instructions for use.

Instructions for use

Two persons are needed: while the first maintains in-line immobilization of the head, neck and torso, the second fits the collar.

Single-patient multiple use.

Precautions for Use

  • When wearing a cervical collar for more than 10 days, a progressive weaning is necessary using a lighter support collar.
  • Ensure the chin piece is in correct position and that the size is fixed at all time during use as detachment of collar during use can lead to severe neck injury.
  • Immobilization with a collar is not recommended in trauma patients with penetrating injuries

Maintenance

In case the device needs to be reused, it must be with a detergent/disinfectant solution 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.

MSF requirements

Easy to fit, light, washable.

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