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(PRO Drill) LINEN, autoclavable RPL-005

https://unicat.msf.org/cat/product/87798
STD EEMDDRIA607

Valid Article

Z12130580 - Motorised orthopaedic surgery system instruments - hardware accessories
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
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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(PRO Drill) LINEN & TEXTILE GUARD DrillCover PRO

Definition

Fabric cover for the surgical dril PRO Drill. The drill itself is not sterilised, but it comes with a cover that is sterilised by steam autoclaving.

Cover Guard protects the PRO Drill linen from impacting or puncture pins, Kirschner-wires or other hardware during loading or use, from accidentally contacting sharps or being dropped too hard on hard surface, etc..

Specifications

LINEN

  • Textile bag made of 3 layers
    • Outer fabric: woven polyester layer
    • PTFE membrane: prevents transfer of liquids, bacteria, pathogens, viruses
    • Inner fabric: woven polyester layer
  • Barrier level: level 4 ANSI/AAMI PB70 barrier performance against fluide penetration and micro-organisms (bacteries and viruses)
  • Fully-taped seams
  • Lifetime linen: replacement after 75 sterilisation cycles (autoclave)
  • Autoclavable with steam autoclave at 121°C for 30 minutes or 132°C for 4 minutes

TEXTILE GUARD

  • Medical-grade silicone
  • Puncture resistant
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Instructions for use

Maintenance

Follow the manufacturers' recommendations.

The linen Drillcover PROand cover guard must be pre-disinfected, cleaned and sterilized by steam autoclave after each use (steam autoclave at 121°C for 30 min).

Any solution with a high or low pH may damage the instrument. Do NOT use dish soap, iodine, bleach, cold-soak solution, chlorhexidine-based solution, laundry soap or surgeons hand scrub.

Reprocessing linen together with sharps and hard objects may result in damage to the linen and compromised sterility.

Clean DrillCover linen and cover guard in a detergent/desinfecant solution for medical solution to remove blood and tissue from the device. Scrub soiled areas of linen and cover guard in the solution using a softbristled, non-abrasive brush under the surface of the solution to minimize splashing.

Metal brushes and scouring pads must be avoided, do not scrub the linen fabric against itself, this will damage the linen.

Rinse thoroughly in water.

Allow device to dry completely before sterilization, remove excess moisture with lint-free, soft absorbent towel to speed up drying. Do not wring or twist it. Hang linen in a drying cabinet or on a drying rack in front of a fan.

Please make sure there is no hole in the sterile cover after each sterilisation process.

Wrap the linen together with the cover guard in two sterilization sheets (do NOT fold linen along the same lines after each use: this will create concentrated areas of wear and tear)

  • Lay linen flat
  • Fold lengthwise once
  • Fold widthwise twice, webbing side first, then grommet side on top with the grommet facing upward.
  • Place cover guard on top of linen

Do not exceed 75 use cycles for the linen

MSF requirements

Mandatory and reusable accessory of the PRO Drill surgical drill.

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