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SURGICAL DRILL (PRO Drill) + acc.

https://unicat.msf.org/cat/product/86575
STD EEMDDRIE6--

Valid Article

Z12130503 - Orthopaedic surgical drills
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.
SPM
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3481
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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SURGICAL DRILL (PRO Drill)

Definition

The cordless drill PRO Drill is a battery powered surgical instrument to be used during orthopaedic trauma or surgical procedures for drilling/reaming into bones. It also serves to the fixation or the cut of screws, pins and other fixation material.

It consists of a handpiece, on which one of the two adapters; InLine Adapter for non-cannulated drilling and reaming or Cannulated Adapter for either cannulated or non-cannulated drilling and reaming. Each adapter accepts reamers and drill bits with either Hudson or Zimmer (also referred to as Stryker, Hall-Jacobs or Modified Trinkle) quick-connect shanks. A selection of different drill chucks and quick-connect attachments is available for use with either adapter.

The engine rotational speed is controlled directly on the PRO Drill handpiece.

The PRO Drill is a low cost surgical power drill. The drill itself is not sterilised, but it comes with a sterile cover, which is sterilised. Please make sure there is no hole in the sterile cover after each sterilisation process.

Synonym

Surgical power tool

Specifications

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Components

PRO Drill - MSF Standard Set KIT-PRO-001-C

  • 1 x PRO Drill 12V Drill/Reamer (modified Makita DF032D) with 2x 1.5Ah 12V batteries (Makita BL1016) MK-DRI-002
  • 1 x PRO Drill 12V Battery Charger (Makita part DC10SA/B for 220-240V/50Hz power supply, Type C plug) MK-CHG-002-C
  • 1 x PRO Drill InLine Adapter RPA-006
  • 1 x PRO Drill 7.4mm Drill Chuck with Key RPA-007
  • 1 x PRO Drill AO Small Quick Connect RPA-009
  • 2 x Linen and Textile Guard DrillCover PRO SYST-006
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Technical specifications

  • Speed:
    • Low speed/ reaming: 450 RPM
    • High speed/ drilling : 1500 RPM
  • Torque settings:
    • Drill Position: 9.6 Nm
    • Reamer Position: 32 Nm
  • Internal power supply:
    • 2 battery pack litium-ion of 12 V (DC) <100 Wh
  • Battery:
    • battery life: 20 min under continuous use
    • charging: approximately 30 min
  • Classification of device when assembled for use: internally powered ME Equipment
  • Protection against electric shocks:
    • Adapter and attachments are Type B applied parts.

Dimensions

  • Weight Handpiece: 1.1 kg

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
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To be Ordered Separately

  • 1 x PRO Drill cannulated adapter RPA-005: needed for the Kirschner wire

Instructions for use

Read the user manual provided with the drill before use.

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Maintenance

Follow the manufacturers' recommendations.

The electrical components of the drill and battery cannot withstand water. Use caution to avoid getting water inside the plastic coating of the drill.

The device is not suited for automatic cleaning.

In case the prescribed unloading procedure has not been followed, the outside of the power tool can be wiped with a detergent/disinfectant, for medical equipment. Prepare the solution in required concentration. Use a lintfree cloth moistened with a disinfectant solution to wipe the outside of the power drill. Make sure all the surfaces completely wet. Wait for the surfaces to dry for at least 15 minutes before turning the drill back on. Make sure that no liquid penetrates the power drill!

Attachments and adapters 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.
  • Scrub adapter and attachment bores with a channel-cleaning brush (ESTEBRUS05-).
  • While cleaning chucks, open and close the jaws to reach all areas inside the chuck.
  • While cleaning quick-connects, open and close the locking sleeve to clean the area underneath.
  • Rinse thoroughly in water. Allow device to dry completely before sterilization
  • Individually wrap each adapter and attachment in two sterilization sheets. Wrap chuck keys with chucks.

Storage

  • Temperature: 10 to 40°C
  • Relative humidity: 30 to 70%
  • Atmospheric pressure: 700 to 1060 hPa

MSF requirements

Compatible with the OrthoFix Galaxy External Fixation.

Can be used with Xcaliber cylindrical Bone Screws and drill bits up to 6mm diameter.

This drill is appropriate for surgical missions with low to medium numbers of external fixation cases where the Stryker Cordless driver is not justified in terms of prices but having a power drill may be useful if staff can use it safely.

The PRO Drill can also be the back-up in high-volume ortho projects using the Stryker should there be a failure of the Stryker

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