General Description - Euromed
Transcript of 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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General description of
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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General description of
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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General description of
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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General description of
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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General description of
Euro-Burette
Bill of material
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General description of
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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General description of
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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General description of
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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General description of
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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General description of
Euro-Burette
●EU representative
●CE Mark with number 0120
●Kind of sterilization EO
●Lot number
●Expiry date
●Storage Conditions
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Issue / Revision No: - 01/02
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General description of
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