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(C-arm) COMPLETE PROTECTION COVER 3 parts, s.u., sterile

https://unicat.msf.org/cat/product/90207
STD EDIMXRFC103

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(fluoroscopic x-ray) PROTECTION COVER C-Arm, s.u., sterile

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Definition

Sterile, single-use plastic protective cover for fluoroscopic x-ray system (C-arm) to protect them from body fluids, blood and contaminants

Specifications

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Technical specifications

  • highly resistant polyethylene
  • antistatic
  • transparent
  • sterile, single use
  • different sizes according the part to cover:
    • EDIMXRFC103: complete set including 3 covers for the 3 parts
      • 2 banded bag covers‌ (min 100x60 cm)
      • 1 C-arm cover
    • EDIMXRFC102:
      • for part 1 (image intensifier or flat detector) or part 3 (x-ray tube)
      • minimum 100 x 60 cm
      • elastic fixation/ banded bag

Packaging & Labelling

Varying according the manufacturer: box of 20, 40, 60, 80...

MSF requirements

Sterile cover for orthopaedic interventions: internal fixations.

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