Download English - Medicontur

INSTRUCTION FOR USE
KONTUR BSS irrigating solution for ophtalmic surgery
Content:
500 ml or 1000 ml clear, transparent balanced salt solution.
Description:
KONTUR BSS is a physiological isotonic ophtalmic irrigating solution (OIS) for intraocular or topical
irrigation of the eye during ophtalmic surgery.
Table 1. Composition
Ingredients
Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium acetate trihydrate
Sodium citrate dihydrate
Hydrochloric acid (to adjust pH)
Water for injections
1000 ml solution contains (mg)
6400
750
480
300
3900
1700
q.s.
q.s.
Table 2. Characterisation
Classification according to pH and buffering capacity
group
base buffering capacity
acid buffering capacity
(mol/l per pH)
(mol/l per pH)
essentially unbuffered
0.0001
- 0.0009
Osmolality
293-325 mosm/kg
pH range
7.0 -7.6
Indications:
•
Irrigation of the anterior chamber of the eye during cataract surgery and other intraocular surgical
procedures,
•
Flushing out alpha-chymotrypsin following enzymatic zonulolysis,
•
Intraoperative irrigation of the anterior chamber of the eye in hyphaema,
•
Irrigation of the cornea during strabotomy and other extraocular surgical procedures,
•
Irrigation of the conjunctiva following fluorescein instillation,
•
Irrigation of the anterior eye region and lacrimal ducts after corrosive injury and burn
•
Moistening the cornea and conjunctiva during laser treatment
Contraindications:
There are not known contraindications to the use of balanced salt solution.
Packaging:
Clear transparent solution in opaque plastic bottle closed with latex-free rubber stopper/Alu ring and
light blue plastic cap.The overall packaging contains this medical leaflet as well.
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Sterilisation:
This product has been sterilized by steam. The applied sterilisation procedure is marked on the bottle.
Storage:
Do not store above 25 oC.
Do not expose to direct sunlight.
Do not freeze.
Keep dry, protect from moisture/water.
Expiration:
Do not use this medical device after the expiry indicated on the primary container.
The expiry date refers to the first day of the month of expiry.
Conditions of transportation:
Handle with care.
Warnings:
•
Do not use if the sterilized package is open or damaged.
•
Do not resterilize by any means.
•
Do not use if expired.
•
Do not reuse. Any occasional re-use must be avoided as it may pose serious health risk either by
non-sterility or by any mechanical defect caused by the previous use.
•
Not for injection or IV infusion.
•
Use only a clear solution.
Precautions:
BSS contains no preservatives.
Open the container under sterile conditions only.
The addition of any medication to BSS may result in damage to intraocular tissue. There have been rare
reports of corneal clouding or edema following ocular surgery in which BSS was used as an irrigating
solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the
cornea and other ocular tissues.
The aqueous fluid of diabetic patients shows increased osmolarity, intraoperative lens changes may
occur. It is proposed to adjust the osmolarity of the aqueous fluid accordingly.
Since KONTUR BSS is isosmotic with normal aqueous fluids it should be used with caution in diabetic
patients undergoing vitrectomy.
Interactions:
In reasonably foreseeable environmental conditions, no significant interaction or possible damage
caused by exposition to magnetic fields, external electrical influences, electrostatic discharge, pressure
or variation in pressure, thermal ignition sources, and acceleration is known.
Handling:
Use an administration set with an air inlet in the plastic spike since the bottle does not contain a
separate airway tube. Follow directions of the particular administration set to be used.
Grasp light blue plastic cap on top of bottle and flip it up by your thumb, then pull it off.
Remove the aluminium ring by pulling it aside.
Insert spike aseptically into the bottle through the center target area of the latex-free rubber stopper.
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Allow the fluid to flow and remove air from the tubing before irrigation begins.
Method and duration of administration:
This ocular irrigating solution should be used according to the local therapeutic protocol.
The dose and the duration of use depends on the respective situation according to the operative,
therapeutic or diagnostic procedure and should be decided on a case-to-case basis by the attending
surgeon.
BSS is a physiologic solution aligned with aqueous fluid, overdosing (intoxication) is not possible.
Possible per-operative and postoperative complications and undesirable effects
As with any surgical procedure, there is risk involved. The risk can be reduced significantly with
adherence to the instructions provided by the manufacturer
When the corneal endothelium is abnormal, irrigation or any other trauma may result in bullous
keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal
decompensation have been reported. Their relationship to the use of BSS has not been established.
Reporting customer complaints including quality complaints, adverse events and other medical device
related observations:
Customer complaints including quality complaints, adverse events and other medical device related
observations should be reported to Medicontur without delay. A report describing the details of the
complaint/event, the applied therapy, the product type, LOT/serial number of the medical device used is
requested.
Return of product:
If possible, return the medical device and/or its original container and/or any part of the packaging to
Medicontur or to your local distributor.
Contact for complaints:
Medicontur Medical Engineering Ltd.
Quality Assurance
Herceghalmi Road, H-2072 Zsámbék, Hungary
Phone: +36 23 56 55 50
Fax: +36 23 56 55 56
E-mail: [email protected]
Liability:
Medicontur does not bear any responsibility for improper model selection by the physician, for improper
handling, use, surgical technique applied or for any other iatrogenic error caused by the implanting
surgeon.
This product is subject to change with or without prior notice. Improvement changes may be made in
specification, shape and material.
Several product types listed in this Instructions for use may not be marketed.
Please keep this Instructions for use and read it carefully before you apply this medical device. In case
you are not in the possession of the Instructions for use, please request a copy.
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Any national version has been translated from the core English text. Should you face any discrepancy or
problem in interpretation, please use the English version for guidance.
Symbols used:
1. Do not resterilize
2. For single use
3. Keep away from sunlight
4. Keep dry
5. Use by (date)
6. Consult instructions for use
7. Sterilized using steam
8. Batch code
9. Manufacturer
10. CE certified
Waste management:
The product or its waste material should be disposed of in accordance with local/national regulations
and requirements.
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Manufacturer:
Medicontur Medical Engineering Ltd.
[email protected]
www.medicontur.com
Head Office
Herceghalmi Road
2072 Zsámbék
Hungary
Export Office
Chemin des Aulx 18
1228 Plan-les-Ouates
Geneva / Switzerland
Date of issue:
11/2012
The content of this document is subject to change without prior notice.
The symbol * indicates the sections subjects to revisions since the last version.
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