Presentation of fractionated silicone oil
Arciolane is a fractionated, purified, sterile and apyrogenic silicone oil for completely safe vitreoretinal surgery.
It comes in a vial or syringe. In two viscosities, 1300 and 5500 cSt.
Ideal for long-term tamponade: Reduces emulsification phenomena
Thanks to a unique process for extraction of low molecular weight polymers, Arcadophta reduces emulsification phenomena and facilitates the long-term use of Arciolane.
Dedicated packaging for ophthalmic use
For greater security and ease of use, Arciolane is packaged in a syringe made of thick blown glass, reducing the risk of fracture when subjected to strong pressure. It can be connected to all the Vitreotome compressed air systems.
Arcadophta offers a panel of connection kits (ARC for single use, or resterilisable APIS) for all Dorc, Corneal, Alcon, B&L, Oertli systems, etc.
Please refer to the Accessories page.
For some retinal detachments, a tamponade with silicone oil is necessary. Arciolane silicon oil has a low propensity to form an emulsion which gives it very good tolerance. Its low viscosity enables easy extraction even through small transconjunctival incisions. These properties make it an important tool in dealing with complex retinal surgery.
Purified and fractionated medical quality silicone oil, designed for prolonged retinal tamponade.
Instruction for use
Fractionated silicone oil for retinal surgeryÂ Arciolane Â®
Arciolane fractionated, purified, sterile and apyrogenic silicone oil for vitreo-retinal surgery.
PRESENTATION AND PACKAGING:
ArciolaneÂ® is a medical grade purified and fractionated silicone oil, designed for prolonged tamponade of the retina. The product is available in pouched vial and pouched syringe for viscosities 1300 cSt or 5500 cSt. A set of patient labels is provided to allow the traceability. This product contains neither latex, nor Phtalates, nor preservatives.
Prolonged tamponade after surgical treatment for severe retinal detachment (RD) especially: RD with giant tears, RD with proliferative vitreoretinopathy, traumatic RD, RD that complicate a diabetic retinopathy, RD secondary retinal detachment to a viral retinititis .
known hypersensitivity to silicone. Arciolane should not be used in seudophakic patients who have been fitted with a silicone IOL.
As with all surgical procedures, the posterior segment surgery presents risks which the surgeon must evaluate ARCADOPHTA is not liable for any post-operative complications which arise following the use of Arciolane. Some of the potential complications of retinal detachment surgery or of silicone oil implantation are: per-and postoperative ocular hypotony or hypertony , post operative choroidal detachment, corneal epithelium edema, secondary retinal detachment, cystoid macular edema, infection (endophthalmy), glaucoma by angle closure, keratitis, cataract, late emulsification of the silicone oil.
Do not re-sterilize, single use only. The sterility and purity of the product are only guaranteed for a single use. Do not use if the sterile pouch has been compromised. Do not use after expiration date. It is recommended that silicone oil be removed once satisfactory results have been achieved.
Silicone oil has a limited ability to absorb light that could result in excessive retinal damage in case of photocoagulation. Silicone oil has a comparatively
high refractive index that can result in a significant refractive error when calculating IOL power using standard formulas.
DIRECTIONS FOR USE:
Before use, check the integrity of the individual pouch preserving the sterility.
- Vials: Transfer in aseptic conditions the content of the vial into a sterile syringe.
- Syringe: Do not use ARCIOLANE syringe with a pressure higher than 5 bars (72.5psi) as it could cause the syringe breakage and result in serious injury.
Note: the ARCADOPHTA connection accessories for the ARCIOLANE syringes (ARC, APIS) cannot be used with a pressure higher than 4 bars. Before use remove the white stopper from the top of the syringe by rotating it a quarter turn. The syringe is ready to be used. Connect the syringe in a silicone oil injection machine.
Removal: When removing the silicone oil, make sure that there are no silicone blebs in the vitreal cavity. Once withdrawn from the patient, Arciolane should be discarded as any human biological product. Strictly reserved for surgeons trained in retinal surgery.
Dry heat and autoclave.
keep at room temperature in a dry, protected area.