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BLOOD TRANSFUSION BURETTE, 150 ml, sterile, s.u.

https://unicat.msf.org/cat/product/45187
STD SINSSEBG2--

Valid Article

Former Code(s): SINSZFR0071
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).
Article is intended to be used with children (<12 years) ONLY.
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.
A03010102 - Infusion controllers with filter (also transfusion controllers)
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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BLOOD TRANSFUSION BURETTE

Definition

The transfusion burette is used to administer blood or blood products from a container to a child's vascular system through a needle or catheter inserted into a vein. The device includes tubing, a graduated burette, a flow regulator, a drip chamber, an infusion line filter and a hollow spike to penetrate and connect the tubing to a pouch.

Specifications

for the Multimedical article:

1 - Spike with 3µ air filter

2 - Small clamp

3 - Burette

4 - 150 ml cylinder

5 - Float valve

6 - Button cover

7 - Drip chamber

8 - Blood filter - 200µ

9 - Roller

10 - Flash-back connector

12 - Luer lock male cap

Image

Quality standards

ISO 1135-4, 2015, edition 6, Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed

Technical specifications

  • Proximal connector: spike to connect to the blood bag.
  • Graduated burette of 150 ml
  • Drop counting Chamber
  • Blood filter of 150 – 220 µ (to be used with whole blood, not leucocyte depleted), located in the drop counting chamber or in the burette
  • Thumb wheel regulator: to adjust transfusion rate
  • Tubing: transparent, PVC is an option, preferred phthalates free as for use in neonates. Without injection port (preferable). Length: 150 – 200 cm. Internal diameter: +/- 3 mm. (low priming volume is preferred) smaller diameter acceptable
  • Distal connector: male Luer lock connection with protective sheath.
  • Sterile, for single use.

Packaging & Labelling

single unit package, sterile, peel open

Instructions for use

Start the transfusion as soon as the transfusion set is connected to the blood bag. The blood unit must be administered within a maximum of 4 hours.

The transfusion set has a drop factor of 15 drops of blood/ml (or 20 drops of distilled water)

Follow transfusion protocols in the country of use, and, as a minimum, the following ones

Precautions for Use

  • The transfusion burette cannot be used with an infusion pump!
  • Nothing should ever be added to a blood transfusion line. If necessary, use a separate IV line.
  • The burette must be hanging in a vertical position throughout the transfusion.
  • During the transfusion, check the flow rate periodically by counting the drops.
  • The transfusion set must remain a closed system and is single use only (1 patient/1 transfusion).
  • Never disconnect the transfusion set from the blood bag. Discard as one unit.

MSF requirements

The transfusion set with burette is designed to deliver blood products via gravity. The burette enables the user to accurately measure a prescribed volume of blood in 150 ml increments or less. It is the preferred method to administer transfusions to paediatric patients when an infusion pump (including the specific transfusion set) or syringe pump and trained healthcare worker are not available.

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