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UMBILICAL CORD CLAMP, sterile, s.u.

https://unicat.msf.org/cat/product/18527
STD SDREUMBC2--

Valid Article

Former Code(s): SDREZYN1005
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.
V0202 - Umbilical clamps and clippers, single-use
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
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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UMBILICAL CORD CLAMP

Definition

A sterile manual instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating the cord, and is intended to enable aseptic haemostasis.

Specifications

Technical specifications

  • plastic material (latex free)
  • serrations on the two contact areas
  • security lock with a click to indicate correct locking of the cord clamp and protect against accidental re-opening.
  • serrations tighten when closed
  • smooth edges
  • sterile, for single use
  • Length: +/- 55 mm
  • Width: middle +/- 5 mm, end +/- 10 mm
  • Height when closed: +/- 11 mm

Packaging & Labelling

Each clamp is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage until needed for use and facilitating proper aseptic presentation.

Secondary packaging: box of 100 or 125.

Instructions for use

  • Wait at least 1 to 3 minutes before clamping the cord
  • Clamp the cord with two forceps 10 cm from the umbilicus and cut in between. Use sterile blade or scissors.
  • Tie off the cord with a cord clamp, leaving a 2 to 3 cm stump.
    • rotate the clamp with the open side towards itself so that the locking teeth are visible.
    • thick umbilical cords must be clamped at the ring side
    • both teeth must be correctly positionned
    • to close the clamp, both teeth must be heard to engage with a "Click"
  • Disinfect the umbilicus: apply 7.1% chlorhexidine digluconate to the tip, stump and base of the cord.
Image

Precautions for Use

  • If the baby has a thick umbilical cord, then the cord must be placed towards the ring end of the clamp to ensure a correct closure.
  • Avoid to put these clamps in ANC kits if precise instructions cannot be given to the users.

MSF requirements

Included in the interagency emergency health kit.

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