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(pump Flocare) ADMINISTRATION SET, ENFit, ster.,s.u. 586514

https://unicat.msf.org/cat/product/71418
STD EEMDENPC102

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.
Z12030385 - Infusion instruments – consumables
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
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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(pump Flocare) ADMINISTRATION SET

Two models of administration sets can be ordered according to the brand of your feeding pump.

The Applix pump is no longer produced but the sets can still be ordered.

Definition

A device intended to enable connection of components of an enteral feeding system using an electrical pump. It is typically a small plastic device containing a lumen to facilitate enteral administration of feeds after connection; it has no additional functionality and is dedicated to enteral feeding applications. This is a single-use device.

Specifications

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Quality standards

  • ISO 80369-1, 2018, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
  • ISO 80369-3, 2016, edition 1, +A1 2019 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

Technical specifications

  • TUBING:
    • Transparent PVC, DEHP free, latex free
    • Ø internal = 2.7 mm
    • Length: 175 – 200 cm
  • DROP-COUNTING CHAMBER
  • THUMB WHEEL REGULATOR: Allows to adjust feeding flow rate between 0 and the maximal value. Alternative: CLAMP for positioning the pump
  • PROXIMAL CONNECTOR (to the feeding pouch): ENPlus, non compatible with Luer
  • ADMINISTRATION PORT: For medication, hydration and flushing of the tubing, located at 40 cm from the end
  • DISTAL CONNECTOR (towards the nasoenteral tube): connection ENFit, non compatible with luer
  • COLOUR of the ENFit connections: purple is often used for enteral feeding medical devices, but the specific ISO norm does not specify the colour.
  • Sterile
  • For single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

  • Connect the set to the feed container as instructed on the packaging of the pump set.
  • Tube feeding may only commence after correct position of the tube has been validated (e.g. by pH measurement of gastric contents)
  • Follow aseptic practice when handling feed, tubes and feeding sets
  • Flush the tube before and after feed and medication administration, and at least 3 times a day
  • Sets need to be changed every 24 hours

Precautions for Use

Preventing misconnection errors

  • Regularly inspect tubing for proper connections.
  • Reconnect tubing only under good lighting. Trace tubing back to the source prior to reconnecting.
  • Do not modify or try to adapt connections to enteral devices.
  • Do not use IV pumps to administer enteral feedings.
  • Use enteral syringes (that cannot connect with an IV line) to deliver medications enterally.

MSF requirements

Administration set that is required to administer enteral feeding with the enteral nutrition/feeding pump.

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