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VACUUM EXTRACTOR obstetrical (Kiwi OmniCup), manual s.u.

https://medicalguidelines.msf.org/en/node/506
https://unicat.msf.org/cat/product/71860
STD EMEQVENT3--

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.
U1004 - Manual obstetrical extractors, 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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VACUUM EXTRACTOR obstetrical (Kiwi OmniCup), manual s.u.

Definition

An assembly of hand-operated devices designed to facilitate the delivery of a foetus during vaginal childbirth by enabling traction to be applied to the foetal head by means of a suction cup that is attached to the scalp. It consists of a cup with a soft inner liner to prevent tissue damage, a hand-operated pump, and a handle used to apply traction. It is typically used for dystocia, uterine inertia, maternal exhaustion, maternal/foetal distress. This is a single-use device.

Specifications

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Technical specifications

PalmPump

  • simple hand vacuum pump
  • thumb or finger activated vacuum release valve
  • accurate vacuum indicator.

The Kiwi OmniCup

  • a Malmstrom-style cup = rigid type with a firm flattened mushroom-shaped cup and circular ridge around the cup rim
  • universal cup for all presentations
  • low profile: 50mm Ø x 20mm
  • with a handle grip for easy insertion = assists with proper placement in fetal malpresentations
  • flexible stem (length 15 cm) enables the cup to be placed over the flexion point no matter the position of the fetal head

Sterile, for single use

Instructions for use

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Precautions for Use

If traction is misdirected or too forceful, vacuum may be broken. Before replacing cup, examine fetal scalp for trauma and re-assess presentation and position.

As with forceps procedures, there should be a willingness to abandon attempts at vacuum delivery if satisfactory progress is not made.

MSF requirements

The disposable device replaces the reusable one as there were several quality problems notified.

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