General Description - Euromed

Issue Date: - 03 /03/2020

Issue / Revision No: - 01/02

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General description of

Euro-Burette

Sterile infusion set with graduated chamber (burette) for slow intravenous administration of a precise volume of infusion or injectable drug, over a given time. This system limits the risk for hypervolemia (an excessive volume of infusion being given to a patient).

Not to be used for blood and blood products.

Conforms to ISO 8536-5:2004&ISO 8536-4:2013.

General Description:

- The infusion set shall be provided with protective caps to maintain sterility of the

internal parts of the set until

the set is used. The air-inlet device shall be provided with a protective cap over the

closure-piercing device or needle

Burette is a Medical Device which include:

- vented spike covered with protective cap.

- Roller clamp at proximal end and another one at the distal end.

- Graduated Burette chamber top-covered with hanging loop, bacteria retention air inlet

(with snap on cap) and injection port.

- Floating valve in the base of the burette chamber.

- Flexible drip chamber below the burette chamber with filter in its base.

- Distal tube contains Y-Site which provides a port for administration of medication.

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Euro-Burette

Type & Size

# Code No.

Product Name

Tube O.D

Tube I.D

Flow Rate

Length of tube

Flow regulator

Leakage test

Tensile Strength

Closure piercing device

Fluid Filter

Injection Site

GMDN Code

1 073 Burette 100ml

4.1 mm± 0.1

3 mm± 0.1

1000ml/10min

≥1500 mm

Composed of Roller Clamp & Wheel

No Leakage

Pass Pierce Fluid Container

Present Self Sealing

12159

2 075 Burette 150ml

4.1 mm± 0.1

3 mm± 0.1

1000ml/10min

≥1500 mm

Composed of Roller Clamp & Wheel

No Leakage

Pass Pierce Fluid Container

Present Self Sealing

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Euro-Burette

Graduated Chamber

Product Name/Size Code

No Max.

Numbered

Scale Interval

Max. Scale

Intervals

Nominal

Capacity

10ml 5 ml 100ml Euro-Burette 100ml 073

150ml Euro-Burette 150ml 075

Intended Patient Population:

-This product is used for pediatric patient and/or heart-prostrate or kidney-

prostrate patient, also used for patients who need small dosage and mixed

medicine and short interval.

-Patient : Humans , Female , Male Aged: 65+ years , Middle Aged 45-64 years ,

Adult , 19-44 years, Adolescent: 13-18 years, 6-12 years with a people who

need medicine by determine concentration and have week vein cant bear the

Normal infusion ,children from 2-5 , infants less than 23 month

-Use is restricted to qualified doctor or paramedic

Brand Name : Euro Burette

Intended Use:

-Surgically invasive short-term use.

- allows fine control of fluids volumes and avoids inadvertent over-transfusion

-Used to deliver a fixed volume of IV fluid at a fixed rate, sometimes with added

medication.

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Euro-Burette

-The spike is inserted into the solution container. The clamp above the burette is

opened and the burette allowed to fill to the required volume (ensuring the

vent cap is open). Following this, the clamp is closed, the chamber is filled with

fluid and the line primed in accordance with manufacturer’s instructions. Usually

the chamber is squeezed to allow fluid to flow through the chamber and to

displace air upwards. The burette is then filled to the desired level. The fluid flow

is regulated using the lower clamp. If the upper clamp is left shut, the fluid will

stop flowing once the burette is empty.

-The use of the burette allows fine control of fluids volumes and avoids

inadvertent over-transfusion and the intended for infusion sets for the

administration of infusion fluids (electrolytes, carbohydrates, amino acids, fat

emulsions) for medical therapy. They are routinely used in combination with

large volume parenteral solution containers, e. g, glass bottles and plastics

bags. Their design allows adjustment of the flow rate, with only rough estimate

of volume, usually stated in drops per milliliter infused. Glass bottles and plastics

containers graduations have only wide-spaced intervals and are fairly

inaccurate and insufficient when a dosage and reading of only milliliters are

considered.

Materials Composition of Euro- Burette

As shown from the followed tables that is the product Euro- Burette is composed

of the followed material:

# Part name of product Raw Material Contact

1 Spike protector Polypropylene (medical grade) Direct contact with Doctor or Nurse

2 vented Spike (Acrylonitrile Butadiene Styrene)

ABS

Direct contact with Doctor or Nurse & Fluid

container

3 Air-inlet Cap PVC (medical grade)

Direct contact with Doctor or Nurse

4 Injection Site Latex Free Direct contact with Fluid or Medicine

5 Upper Cap of burette body ABS Direct contact with Doctor or Nurse

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Euro-Burette

6 Burette Body Rigid PVC (medical grade) Direct contact with Fluid or Medicine

7 Floating Valve Latex Free Direct contact with Fluid or Medicine

8 Bottom Cap of burette body ABS Direct contact with Doctor or Nurse

9 Drip Needle Stainless steel 304

Direct contact with Fluid or Medicine

10 Drip Chamber PVC (medical grade) Direct contact with Fluid or Medicine

11 Fluid Filter Nylon net Direct contact with Fluid or Medicine

12 Tubing PVC (medical grade) Direct contact with Fluid or Medicine

13 Roller Clamp Polypropylene (medical grade) Direct contact with Doctor or Nurse

14 Y-Site Transparent ABS +Latex Free Direct contact with Fluid or Medicine

15 Luer Lock Connector Transparent ABS Direct contact with Fluid or Medicine

16 Cap of Connector Polypropylene (medical grade) Direct contact with Doctor or Nurse

17 Needle Cover Polypropylene (medical grade) Direct contact with Doctor or Nurse

18 Needle Stainless steel Direct contact with patient

19 Needle Hup Polypropylene (medical grade) Direct contact with Fluid or Medicine

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Euro-Burette

Bill of material

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Euro-Burette

Indications: Infusion sets with Burette are specially designed to administer measured volume

of infusion fluid, drugs Antibiotics through gravity as well as pressure pump

method, especially to administer infusion in children.

Administration of infusion of fluids (electrolyte, carbohydrate, amino acids, fat

emulsion)

Contraindications: - Product should not be used in patients with known hypersensitivity to any of

the materials used.

- Administration of high viscous fluids.

- large blood transfusion.

INSTRUCTION FOR USE: 1-Close both roller clamps.

2-Remove spike protector.

3-Insert spike into I.V. container.

4-Open upper clamp and permit burette to fill required level.

Squeeze drip chamber to fill half full

5-Open door clamp again and permit burette to refill to required level.

Tap burette to remove air bubbles from the solution.

6-Open lower clamp to clear air from tubing. Close lower clamp.

7-Keep upper clamp closed during infusion of solution in the burette.

8-perform venipuncture and adjust flow rate of solution using lower clamp.

9-Medication may be added through

a) The latex injection site on the top of the burette.

b) The latex flash back bulb at the end of the tubing.

10-To refill the burette. close lower clamp and make sure there is solution in the

drip chamber repeat steps 4 and 5 above.

11-- Product is single use only , discard the product in safety box .

Sterilization: -Burette is sterilized by Euromed for Medical Industries. EtO sterilization, biological

indicator testing and aeration process are performed by Euromed for Medical

Industries Company.

--Sterilized by ETO (Ethylene oxide 80% and Carbon dioxide CO2 20%)

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Euro-Burette

Shelf life: -Following sterilization the product has 5 years shelf life, provided that it is stored

in the original packaging in recommended.

storage condition and that the packs are not damaged or opened or

tampered with in any way.

Storage Condition the Temperature limit from 10°C to 35°C

-Sterilized by ETO (Ethylene oxide 80% and Carbon dioxide CO2 20%)

-ETO sterilization is conducted according to ISO -11135-1 standard and has

been validated and approved by the CE competent authority.

●Microbial tests: according to the IP or USP

●Results: products were found sterile

●Stability and reactivity

●General: stable

●Biocompatibility tests

Biocompatibility tests conducted according to the relevant ISO standard 10993.

Accidental Release Measures: If the cylinder cracked, get red from it immediately.

WARNINGS:

●Product is single use only. Re-use of the product can cause change in physical

characteristics.

●The product should be checked for any major complications i.e. in (vented

Spike Body clamp, Flexible tubing, Injection port, Graduated chamber, y-

connector ,S.S Needle )

●Do not re-sterile may increase the EO Residual in the product or physical

property of the products may be change.

●Visually inspect and carefully check the product and packaging before use.

●Improper transport and handling may cause structural/functional damage to

device or packaging.

●Transportation / Dispatch of the material should be done under covered &

safe container to avoid any damage, rain & direct heat.

●Discard after use. Do not recycle, clean or re-sterile.

●Ensure proper disposal of product and packing after use.

●Use the product immediately after opening the packaging please destroy

when it was used.

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Euro-Burette

●This product should be used by a Doctor / Registered Practitioner or

Paramedic.

●- Do not use Diazepam , Carmustin , or calcitriol with burette may lead to 25%

incompatibility

Precautions :

- Read instructions before use.

- Check expiry date prior to use.

- Ensure before use that product / packing is not ruptured or damaged

- Dangerous incompatibilities can be prevented by a plausibility check

regarding the SPC and available sources on compatibility information, also

considering the material used for therapy (e.g. diluent, IV container, IV lines)

and the infusion regimen.

- Assessment and planning of regimes to avoid mixing of drugs, which have to

be administered separately.

- Individual labeling for each drug preparation (including drug, concentration,

patient name).

- Separating the drug doses by time and place. This can include the rinsing of

the infusion system with a neutral IV solution prior to the application of another

drug.

- Consistently checking alternative modes of administration and/or using multi-

lumen catheters.

- Use of appropriate in-line filters can reduce influx of particles which result from

incompatibilities. In-line filters are able to retain solid particles of at least 0.2

μm. As a consequence, the filter may block. This is not a malfunction of the filter,

but should initiate a check of the medication in order to eliminate any

incompatibility.

Possible Complications:

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Euro-Burette

-Only physicians or nurses experienced with its application, corresponding

interventional techniques and possible complications may use this product.

Possible complications can occur at any time pre-, intra- and post-operative.

Combination with other medical devices:

- Burette are usually used in conjunction with solution bags

- The device must be compatible with Cannula male luer lock set

Compatibility with other medical device: Manufacturers / designers of Burette market products necessarily compatible

with Cannula male luer lock and solution bag.

Manufacturers / designers of Burette develop their products taking into account

the specifications of cannula male luer lock which connected to patient and

solution bag ,

All criteria related to the development and production of Burette are studied

with a focus on safety, patient comfort, ease of use and optimization of

treatment

Packaging:

-The sets are individually packed in Pouch consists of polyamide, polypropylene

& Medical Paper which maintains the integrity of the sets.

-Burette shall be sealed individually in a unit packaging.

Packing: -Each 20 pouch in inner box and 6 inner boxes are packed in master carton.

Storage condition: -Shall be stored in cool & dry place.

-Do not exposure to heat or direct sunlight.

-the Temperature limit from10°C to 35°C.

-Keep away from any source of ignition.

labelling and package material Standard: According to ISO 15223-1

●Product name

●Manufacture name and address

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Euro-Burette

●EU representative

●CE Mark with number 0120

●Kind of sterilization EO

●Lot number

●Expiry date

●Storage Conditions

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Euro-Burette

Name Date Reason for Change Version

Shiamaa Rabeey 20 /08 2/ 019 First issue 01

Shimaa Rabeey 03/03/2020 Update description 02

Prepared By Approved By

Name Aya Mostafa Shaimaa Rabeey

Position Quality Assurance Quality Assurance manger

Signature

Date 03/03 /2020 03/03/2020

Documents

General Description - Euromed