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ENTERAL SYRINGE ENFit, 1 ml, LDT, washable

https://unicat.msf.org/cat/product/91502
STD SCTDSYENW01

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 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).
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.
A020108 - Enteral feeding syringes
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.
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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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ENTERAL SYRINGE, ENFit, washable

Definition

A device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device.

It consists of a calibrated hollow barrel (cylinder) made of plastic, and a moveable plunger. The tip is designed to mate only with enteral administration devices and is specifically incompatible with Luer (6%) connectors and intravenous devices.

Specifications

See information on nasogastric and enteral tubes

Quality standards

ISO 80369-3, 2016, edition 1, +A1 2019 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
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Technical specifications

washable syringe allowing a reuse for the same person

3-part syringe: barrel + gasket + plunger

To avoid dosage errors with the large dead space of the regular ENFit syringes, a Low Dose Tip (LDT) was developed.

BARREL

  • transparent polypropylene
  • capacity:
    • regular ENFit: 10 ml, 20 ml and 60 ml
    • ENFit LDT: 1ml, 2.5 - 3 ml and 5 ml
  • easily read graduations
    • 1 ml and 2.5 ml syringe => every 0.1 ml
    • 5 ml syringe => every 0.2 ml
    • 10 ml and 20 ml syringe => every 0.5 ml
    • 60 ml syringe => every 1 ml
  • ending with a female EnFit tip, LDT (low dose tip) for the syringes 1 - 5 ml to decrease the dead space.

PLUNGER

  • polypropylene, polyethylene
  • perfectly fit to slide easily and smoothly inside the barrel
  • purple colour to distinguish from injection syringes.

GASKET

  • synthetic elastomer (latex free)
  • ensures an efficient seal

Packaging & Labelling

Unit packaging

(Cf Introduction: Packaging and labelling)

Instructions for use

Enteral-specific syringes are introduced with the ENFit female connector. They are required to administer medicine, flush, hydrate, or bolus feed through the ENFit feeding tubes and extension sets.

The small LDT syringes are used to administer oral suspensions and medications via nasogastric tubing.

Cleaning instructions

  • do not allow contents to dry in the syringe before washing
  • syringes can be cleaned by washing in warm, soapy water
  • the plunger should be removed and washed separately
  • if visible soil remains, use a soft-bristled brush to aid washing the plunger and the INSIDE of the syringe barrel. Do not use abrasive products on the oiutside of the barrel is this may lead to premature removal of printed markings.
  • rinse each component with cold water and allow to air dry
  • do not dry the components with paper towel as this will shorten the life of the device
  • discard syringe when:
    • black O-ring gasket is distorted or damaged
    • barrel markings are too difficult to read
    • plunger is too difficult to move

Precautions for Use

Oral-tipped and Luer-tipped syringes will not fit the ENFit connector system.

The syringes cannot be sterilised and must be kept single patient use, not to be shared amongst different patients.

Do not use with a syringe driver

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