SURGICAL DRILL (Cordless Driver 4) +accessories

NST EEMDDRIE4--

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Former Code(s): -X EHOEZBE1216 EHOEDRIE4-- EEMD4--
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.
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The order of this product needs to be justified and is only acceptable under certain conditions.
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).
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 (Cordless Driver 4)

The Cordless Driver 4 is no longer produced and is replaced by the Cordless Driver 8 (see “replaced by” at bottom of the page).

Most of the accessories and spare-parts are compatible with the other models. The models are mentioned in the labels of the parts.

Definition

The cordless drill Cordless Driver 4 is a battery powered surgical instrument for use during orthopaedic trauma or surgical procedures for cutting or drilling the bone. It also serves to the fixation of screws or to cut the screw, the pins and other fixation material.

It consists of a handpiece, on which tips and specific tools are fitted depending on the surgical procedure being performed (wicking, reamer, pin collet, sagittal saw or drill). The engine rotational speed is controlled directly on the handpiece.

Synonym

Surgical power tool

Specifications

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Components

  • 1 x Cordless Driver 4 Handpiece ref. 4405000000
  • 1 x Synthes Drill ref.4100110000
  • 1 x Synthes Reamer ref.4100210000
  • 1 x Sagittal Saw Attachment ref.4100400000
  • 1 x Drill with Jacobs chuck (Ø 6,35mm = ¼ inch) ref. 4100131000
  • 1 x Reamer with Jacobs chuck (Ø 6,35mm = ¼ inch) ref. 4100231000
  • 1 x Pin Collet ref.4100125000
  • 1 x Hudson Modified Trinkle Reamer ref. 4100235000
  • 1 x Battery Charger (system 7) ref.7110120000
  • 1 x Non-Sterile (Aseptic) Small Battery ref. 722211000
  • 1 x Small Transfer Shield ref. 7222130000
  • 1 x Aseptic Battery Housing CD3-4 ref. 7222120000
  • 1 x Sterilisation Tray ref. CMNETH

Technical specifications

  • Operating Cycle:
    • Forward / back running: cycle of 5 times 1 min running/ 4 min off , with 2 h break
    • Operating in oscillation mode: cycle of 5 times 15 sec running /15 sec off, with 90 min break
    • Operating with sagittal saw tip: cycle of 4 times 10 sec running / 20 sec off, with 90 min break
  • Speed:
    • Drill Position: 1500 tr/min
    • Reamer Position : 303 tr/min
  • Couple:
    • Drill Position: 3,3 Nm
    • Reamer Position: 15,7 Nm
  • Motor cannulated: 4,0 mm
  • Double trigger with forward, backward, alternating mode
  • Protection rating against penetration: IPX 0 (not water resistant)
  • Internal power supply:
    • 9,9 V (DC) battery pack by Smart Life Stryker (lithium-ion)
    • 9,6 V per battery pack System 6 (nickel-cadmium)
  • Battery life: 20 min under continuous use with Lithium-Ion
  • Operating conditions:
    • Temperature: 10° to27°C
    • Atmospheric Pressure: 700 to 1060 hPa
    • Relative humidity: 30 to 75 %

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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Instructions for use

Read the user manual provided with the drill before use.

Maintenance

Cleaning / Washing: no not immerse

Sterilisation: autoclavable at 134°C

Always remove the battery before sterilisation in the autoclave.

(Cf Introduction: Disinfection and sterilization in the field)

Periodic maintenance:

  • Before each use: Inspect, test and activate the handpiece to ensure proper operation.
    • Check that no parts are loose or missing.
    • Check the free movement of all moving parts.
    • Pay attention to any abnormal noise or vibration and note the operating speed.
  • Every 3 months: Try the tip of sagittal saw with the handpiece for one minute to determine the operating temperature. If the distal end and the body of the piece are heated to an uncomfortable temperature to touch 43.3°C, send the handpiece and the tip to ASS .
  • As needed: If the operation of the type of tips chuck or keyless freezes, apply a specific oil for surgical instruments on the jaws of the tip. Wipe off excess oil
  • As needed: If the handpiece release button on the wireless engine 3 freezes, apply a specific oil for surgical instruments to the handpiece.

For detailed information on maintenance and sterilization of the device, refer to the manual supplied with it.

Storage

  • Temperature: -20 to 40°C
  • Relative humidity: 10 to 75%
  • Atmospheric pressure: 500 to 1060 hPa

MSF requirements

Surgical drill necessary to perform internal fixations, and other orthopaedic procedures.

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