DRESSING, HAEMOSTAT., chitosan rapid Z-fold. 7X150cm (Celox)

STD SDREBHAECR071

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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).
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.
M040504 - Inorganic haemostatic devices
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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HAEMOSTATIC DRESSING, chitosan

Definition

A sterile, non-bioabsorbable dressing made with chitosan intended to be applied to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for surgical use.

Haemostatic agents use is limited to the severe-moderate bleeding as temporarily dressing before referral to the closest hospital before definitive control.

Specifications

Mucoadhesive agents create a strong adherence to tissues and physically seal bleeding wounds. Most brands use chitosan, a naturally occurring, bio-compatible polysaccharide derived from shellfish, and work in this fashion.

On contact with anionic erythrocytes, the chitosan salts rapidly ‘cross-link', adhering strongly with the wound surface. This adhesive process is thought to be the primary mechanism of action; independent of platelets or clotting factors.

Chitosan is extracted from shrimp shells, there are however no cases on record of allergic reaction to chitosan based haemostatics, even in those with a known seafood allergy.

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Technical specifications

  • Z-folded viscose compress
  • 8 g of chitosan granules (high surface area macro-granules) on the compress
  • Sterile, for single use
  • 7.6 x 152 cm gauze strip
  • 14 x 11 x 1.4 cm foil pouch
  • weight = 32 g

Packaging & Labelling

Each sterile dressing is individually wrapped in a vacuum metallized pack with the IFU printed on the outside.

(Cf Introduction: Packaging and labelling)

Instructions for use

The primary treatment for all serious bleeds is direct pressure; all haemostatics are designed to be used with direct pressure at the site of the bleed – directly onto the bleeding artery, deep within the wound if necessary. Haemostatic dressings are not a ‘magic powder' that can be casually applied somewhere near the wound and left to work.

  • Tear open pack. Take out the Celox and take one end of the Z-folded gauze.
  • Tightly pack the unfolding Celox directly to the source of the bleeding. Pack remaining wound cavity with Celox or standard gauze. Excess Celox can be torn or cut if necessary.
  • Apply FIRM pressure directly to the wound for AT LEAST ONE MINUTE or until bleeding stops.
  • Wrap and tie with a bandage so as to maintain pressure on the wound.
  • Discard any remaining Celox.
  • Transfer patient to medical facility as soon as possible.
  • Show empty pack to medical personnel (do not assume the hospital will know how to deal with the haemostatic you have applied)

For further care: physically remove gauze from the wound and any loose surface granules. Fully flood entire wound area with sterile saline irrigation solution. Proceed with normal irrigation and / or suction. Ensure all product is removed from the wound prior to initiation of wound treatment.

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Precautions for Use

  • Device not intended for surgical (internal) use as it is not X-Ray detectable.
  • Do not apply over eyes. If eye irritation occurs flush with water for five minutes.

Storage

  • Store below 30°C
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