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SURGICAL DRILL (Cordless Driver 8) +accessories

https://unicat.msf.org/cat/product/74717
STD EEMDDRIE5--

Valid Article

Former Code(s): EEMDZTR0001
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PME
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 (Cordless Driver 8)

Definition

The cordless drill Cordless Driver 8 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.

The Cordless Driver 8 is replacing the previous models which are no longer produced CD4 and CD3. Most of the accessories and spare-parts are compatible with the other models. The models are mentioned in the labels of the parts.

Synonym

Surgical power tool

Specifications

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Components

codelabelqty
EEMDDRIA401(perceuse CD4-8) PIECE A MAIN 44050000001
EEMDDRIA407(drill CD3-4-8) SYNTHES DRILL, AO fitting, small 41001100001
EEMDDRIA409(drill CD3-4-8) SYNTHES REAMER, large 41002100001
EEMDDRIA411(drill CD3-4-8) SAGITTAL SAW ATTACHEMENT 41004000001
EEMDDRIA429(drill CD3-4-8) JACOBS DRILL, Ø 6,35 mm 41001310001
EEMDDRIA410(drill CD3-4-8) JACOBS REAMER, Ø 6,35mm 41002310001
EEMDDRIA408(drill CD3-4-8) PIN COLLET, 2 to 3.2 mm 41001250001
EEMDDRIA402(drill CD3-4-8) HUDSON MODIFIED TRINKLE REAMER 41002350001
EEMDDRIA403(drill CD3-4-8) BATTERY CHARGER, system7, 7110120000E1
EEMDDRIS502(drill CD4-8) SMARTLIFE BATTERY, large non ster.71261100002
EEMDDRIA405(drill CD4-8) TRANSFER SHIELD, small 72221300001
EEMDDRIA502(drill CD8) SMARTLIFE BATTERY HOUSING,asept.large 71261200001

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
    • ReamerPosition : 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 against solid/ liquid ingress: IPX 0 (not water resistant)
  • Internal power supply:
    • 9,9 V (DC) battery pack by Smart Life Stryker (lithium-ion) <100Wh
    • 9,6 V per battery pack System 6 (nickel-cadmium) <100Wh
  • 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 %

Dimensions

  • H x W x L:137 x 34 x 103 mm
  • Weight Handpiece: 0,58 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
Image

To be Ordered Separately

Instructions for use

Read the user manual provided with the drill before use.

Maintenance

Cleaning / Washing: do 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.

June 2024: second battery added in the composition list

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