Intended purpose | Medical devices

For devices falling within the scope of Directive 93/42/EEC (Medical Devices Directive, applies to ICOmed, SN, SF, SNplus, SFplus) or Regulation (EU) 2017/745 (Medical Devices Regulation, applies to UNm, UFm, UNmplus, UFmplus, INm, IFm, INmplus, IFmplus, IFbw), the following intended uses apply:

  • For Universal Ovens series UNm, UFm, UNmplus and UFmplus: The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.
  • For Incubators series INm and IFm: The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.
  • For Incubators series INmplus and IFmplus: The appliance may be used for temperature control of rinsing and infusion solutions and contrast agents.
  • For Sterilisers series SN, SF, SNplus and SFplus: The product is intended for the sterilisation of medical products with dry heat at atmospheric pressure.
  • For CO2 Incubators series INCOmed: The appliance is intended for the creation and maintenance of constant environmental conditions for application in the field of in vitro fertilisation (IVF), especially for the incubation of oocytes, spermatozoa and zygotes in special culture dishes for IVF application as well as for gene expression and the biosynthesis of RNA and proteins.
  • For Blanket Warmer series IFbw: The appliance may be used for heating non-sterile covers and cloths.
  • For CO2 Incubators series ICOmed: The appliance is intended for the creation and maintenance of constant environmental conditions for application in the field of in vitro fertilisation (IVF), especially for the incubation of oocytes, spermatozoa and zygotes in special culture dishes for IVF application as well as for gene expression and the biosynthesis of RNA and proteins.

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