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DERMATOME, ELECTRICAL (ACCULAN 3Ti) with battery + access.

https://unicat.msf.org/cat/product/12751
NST EEMDDERE5--

Outdated Article

Former Code(s): EHOEDERE51-
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.
Z120103 - Dermotomy equipment
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
M
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).
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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DERMATOME, ELECTRICAL (ACCULAN 3Ti)

Stopped in 2019 because no longer produced and replaced by the new model‌ EEMDDERE6-- STD DERMATOME, ELECTRICAL ACCULAN 4 (see “replaced by” at bottom of the page)

Definition

A battery-powered surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade. A rechargeable battery pack is connected to the instrument to provide the electrical power for operation. This is a reusable device.

Specifications

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Technical specifications

  • Blade travel: 3.1 mm
  • 6300–6800 strokes/min
  • Size of cut:
    • 78 mm width maximum
    • adjustable with 10 flaps of 8 mm wide
  • Thickness of cut:
    • 0.2 mm to 1.2 mm
    • graduation every 0.1 mm
  • Dimensions: 285 x 115 x 50 mm
  • Autoclavable à 134ºC (= 2 bars) or 121ºC (= 1 bar)

Packaging & Labelling

  • Dermatome + accessories: unit packaging.
  • Blades: unit sterile packaging (box of 10)

(Cf Introduction: Packaging and labelling)

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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Supplied with the Article

  • 1 cover
  • 1 sterile funnel
  • 1 rechargeable battery (Li-ION)
  • 1 battery charger
  • 1 storage tray
  • 30 single use, sterile blades

Instructions for use

Read the instructions manual carefully.

To be used only by practitioners who are trained in this technique.

Precautions for Use

To avoid damaging the device through improper assembly/operation and losing the manufacturer's warranty:

  • Use the device only according to the instructions for use
  • Follow safety and maintenance instructions

Maintenance

The dermatome must be cleaned and sterilized by steam autoclave after each use. Remove the rechargeable battery and dismantle the components with great care, without forcing.

(Cf Introduction: Disinfection and sterilization in the field)

Waste management

Immediately after use, dispose of the blade into a sharps container

(Cf Public Health Engineering In Precarious Situations, MSF, 2010, Chapter 6)

MSF requirements

Alternative to the manual dermatome (see related articles below)

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