ELECTRO SURGICAL UNIT (Surgilec MC2), 220 V + accessories

NST EEMDESUE4--

Discontinued Article

Former Code(s): EHOEELSU4MC
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.
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.
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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ELECTRO SURGICAL UNIT (Surgilec MC2)

The article was stopped in 2018 because no longer produced. It is replaced by the model Lamidey SEAL‌ (see “replaced by” at bottom of the page).

Definition

Electro surgical generator, used in surgery for the cutting of soft tissues and coagulation.

Specifications

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Quality standards

EN IEC 60601-2-2 , 2018, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Components

  • 1 electro surgical generator
  • 10 handpieces
  • 2 sets of 15 short cutter electrodes
  • 3 patient return electrodes
  • 1 split patient return electrode
  • 1 French/English instructions leaflet

Technical specifications

  • ELECTRO SURGICAL GENERATOR
    • the setting of the continuous currents for cutting and coagulation is operated independently
    • possibility of continuous setting in case of haemostatic cutting (= modulated cutting)
    • power for monopolar mode:
      • 200 W / 400 Ω in cutting mode
      • 80 W / 400 Ω in coagulation mode
    • power supply: 220-240 V / 50-60 Hz (110 V adaptation on request)
    • unit supplied with fuses
    • power cable
    • dimensions: 35 x 30 x 15 cm
    • weight: 7.7 kg
  • HANDPIECE
    • model: Tactilec C
    • 3 points plug
    • hand operated with normalized buttons' colour: yellow for the cutting, blue for the coagulation (the coagulation is overriding the cutting)
    • non sterile, autoclavable: withstands more than 250 sterilization cycles at 134º C
  • MONOPOLAR ELECTRODE
    • = active electrode: it is the electrode which carries the current where it is needed
    • short cutter type
    • non sterile, autoclavable
  • PATIENT RETURN ELECTRODE
    • model Siliplaque C
    • = neutral electrode: ensures the reverse of the current and closes the circuit
    • flexible, mono-surface type
    • wide contact surface
    • supplied with cable
    • non autoclavable

Safety features

  • Automatic limitation of output voltage
  • Indifferent sonorous and visual security for the plate conductor and for the contact plate/patient with the adhesive double faced plate
  • Reduced emission of interferences and limitation of HF leakage current
  • Alarm in case of HF overpower
  • Device protected against defibrillation shocks

Packaging & Labelling

Instructions for use

To be used by qualified staff only.

Read the manufacturer's notice carefully.

The patient return electrode has to be applied as widely as possible on the patient's bare skin and as close as possible to the surgery field.

Secure the electrical protection of the apparatus with a double conversion UPS (see related articles below).

Precautions for Use

CAUTION, DANGER OF BURN:

  • if the contact surface between the plate and the patient is too small (current concentration)
  • if the plate is not always dry (liquids are electric conductors)

Maintenance

The electrode-holder and the electrodes must be cleaned and sterilized by steam autoclave after each use. Always leave the electrodes to cool down after sterilization.

The plate is not autoclavable and must be cleaned and disinfected with a 0.5% detergent-disinfectant solution for medical devices (i.e. 25 ml = 1 stroke of dosing pump for 5 litres water). Do not leave to dry in the sun.

(Cf Introduction: Disinfection and sterilization in the field)

MSF requirements

Article selected for two of its functions: monopolar cutting and coagulation (for general surgery).

Easy to use and compact, it ensures all safety required for high quality bistouries.

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