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SMARTSIL 1000/5000

Instruction for use


Purified Silicone Oil for Vitreoretinal Surgery

  • Maximum interfacial tension and minimum interactions between tissues, cells and endo-tamponades media
  • Optimal combination of specific gravity, refractive index and surface tension
  • The choice of viscosity for a balance between easy injection and a stable temporary tamponade
Physico-chemical properties
Interfacial tension ≥ 40 mNm-1 at 37°C
Density 0.97
Viscosity 1000/5000 cSt
Refractive index 1.40
Volatility < 1%
Polydispersity < 2.80
Volume of oil 10 ml
Syringe 20 ml
Shelf Life 3 years
GPC
GC
Purification
  • Vacuum molecular distillation solvent-free purification
  • Potentially toxic low molecular weight oligomers (D4 to D20) extraction
  • Residual volatile components extraction (water, ethanol, etc.)
Sterilization
  • Silicone oils are dry-heat sterilized
  • Syringes are steam sterilized
Post-purification controls
  • Gel permeation chromatography (GPC)
  • Gaseous chromatography (GC)
Packaging
  • Syringes are supplied sterile under double pouch
Indication

SmartSil 1000/5000 is used for prolonged tamponade after surgical treatment for severe retinal detachment (RD), especially:

Purification
  • RD with proliferative vitreal retinopathy
  • RD with diabetic retinopathy complications
  • RD with giant tears
Sterilization
  • Traumatic RD
  • Secondary RD with viral retinitis