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FLOW REGULATOR, for gravity infusion

https://unicat.msf.org/cat/product/53009
STD SINSSETIFRG

Valid Article

Former Code(s): SINSZFR0086
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.
A030104 - Flow regulators
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.
I sterile
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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FLOW REGLATOR, for gravity infusion

This device doesn't replace the nurse's responsibility to monitor the infusion of the prescribed therapy = you still need to count the drops to match the set rate on the dial.

It does not replace electric syringes or volumetric pumps (with much higher accuracy and safety).

Definition

A manual device designed to control the infusion rate through gravity intravenous administration infusion sets. It typically consists of a mechanism that regulates the flow using a calibrated dial that permits control of the flow rate in a given range.

The device is used in-line with gravity infusion administration sets. This is a single-use device.

Specifications

Technical specifications

  • Extension set with flow controller for infusion, with or without injection site
  • Adapts to all conventional infusion tubing, Luer connection
  • Speed from 5 to 250 ml / hour
  • Sterile, for single use

Instructions for use

See SOP in the nursing library:

  • 15.13.D. SOP Flow regulator adult patient use V1 2023 EN.pdf
  • 15.12. SOP Methods of Administering Intravenous Medications and Fluids V1 2022.pdf

Precautions for Use

Do not use Rate Flow Regulator for blood transfusion or for highly viscous fluids.

Drop rate is affected by various factors such as hydrostatic pressure (height of the infusion bottle above the patient), venous pressure, patient movement, catheter/needle size and location, fluid viscosity, pressure in fluid container, fluid head-height etc. Changes in any of these factors during infusion can lead to variations in the drop rate.

MSF requirements

Allows greater accuracy of the infusion rate

The use of the different IV flow devices:

When to use

Precautions for use

IV set only

  • Used for gravity intravenous administration of infusions and medications, excluding blood and blood products.
  • Not recommended for paediatrics or neonates.
  • Must remain a closed system connected to an IV bag at all times.

IV set + gravity flow regulator

  • To regulate the flow of IV fluids or IV medications by gravity to ensure a constant rate.
  • For ADULT patients in ambulances, ER's, IPD's where infusion/syringe pumps are not available or routinely used.
  • Do not use the flow regulator with blood/blood products or with solutions with a viscosity higher than that of a 10% glucose solution.
  • Do not use in paediatric and neonatal patients.
  • Use with caution and under strict control of the flow rate in case of administration of solution whose any possible variation in the flow would be dangerous.
  • In situations where the medication flow needs to be precise and constant an infusion pump should be used. The flow regulator is not a replacement for a syringe pump nor infusion pump.

Syringe pump

  • To infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency.
  • To deliver a consistent rate and pressure over a required period of time.
  • To infuse very small volumetric infusion rates.
  • For continuous medication infusions over an extended period at slow infusion rates

  • Accurate and safe maintenance/replacement fluid administration for neonatal patients. Total volume to infuse is dependent on syringe size

  • All medications requiring a continuous infusion MUST be administered by syringe pump only.
  • Used primarily for neonatal, infant, palliative care or critically ill patients when fluid volume and accuracy is a concern
  • Additional 5 ml flush required after every medication to flush the infusion line of the remaining medication at the same rate of administration.
  • Requires luer lock compatible syringes, and user must choose syringe being used on the pump.
  • Uses dedicated infusion lines.
  • User should be familiar with operating system
  • Dependent on battery life/electricity.
  • Must remain a closed system connected to a syringe at all times.

Infusion pump

  • To facilitate the accurate and consistent administration of medications and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes.
  • It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers.
  • For ICU levels of care.
  • Dedicated infusion set
  • User should be familiar with operating system.
  • Dependent on battery life/electricity
  • Must remain a closed system connected to an IV bag at all times.
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