Invasive medical devices

The flexibility offered by optical fibers for laser light transmission has been a major progress for invasive applications of medical laser. However developing and manufacturing safe products requires solving rather complex technical problems..

Dermatology, cardiology, ophthalmology, oncology, dentistry, aesthetics… high power laser, visible light, fluorescence, sensors signal… all these issues are very different but in every case the system performance is highly dependent of the fiber probe quality and construction.

 

A medical fiber probe generally includes:

  • An optical fiber with or without protection
  • An SMA connector
  • An hand piece (option)
  • A customized distal end
  • An RFID security system

Biocompatibility

The fibers that we propose, either HCS or Silica / silica types, are USP Class VI biocompatible, non toxic and ETO sterilizable. Simple protections of silicon or Teflon tubes can be used with biocompatibility certificates as well as latex free or phtalates free certificates.


Single use

Costs issues are very important in the design and manufacturing process of disposable medical devices to make them compatible with single use. However low cost has to be compatible with safety and reliability of the products.

For this purpose the SMA connector commonly used for medical probes has been totally redesigned in two models: “One shot” and “Power shot” (free-standing). The assembly procedure is “crimp and cleave” type, a very quick process avoiding the use of glue often a problem for sterilization. These connectors are compatible with most standard hand pieces.


Qualification Reliability

For all custom design requests SEDI-ATI can help with an R&D team having long experience of medical applications and constraints, as well as a Quality department with transverse responsibility to elaborate quality and reliable of products.

 


Certifications et conformity

– ISO 13485 : 2012

– ISO  9001 : 2008

– CE 0476 Directive 93/42/EEC

– ISO 11607 (Packaging)

– ISO Class 7 (Salles Blanches)

        


Sterilization


ETO sterilization is outsourced under our responsibility in conformity with CE 93/42


Achievements / Products

Main qualified designs
  •  "One Shot" Probes (Bare Fibers)
  •  "Ring" Probes for EVLT applications
  •  "Curved" for Urologie
  •  "FireFly" Diffusors