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ELECTROSURGICAL SYSTEM (Lamidey SEAL), 230V + accessories

https://unicat.msf.org/cat/product/79477
STD EEMDESUE10-

Valid Article

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.
Z12010902 - Electrosurgical units (esu) for general use
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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Documents

  • EEMDESUE10- ELECTROSURGICAL SYSTEM (Lamidey SEAL), 230V + accessories - PIITM.pdf
  • Bistouri Electrique Lamidey SEAL (Manuel d'Utilisation)

ELECTRO SURGICAL UNIT (Lamidey SEAL)

Definition

This electrosurgical unit is a medical device intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes. It is not intended for argon electrosurgery.

Specifications

The SEAL is an output electrosurgical generator that provides the power for cutting, desiccating, fulgurating and coagulating tissue during surgery. The generator is used for bipolar and monopolar electrosurgical procedures. A thermocision mode is available as an option.

The generator features computer controlled Instant Response Technology designed to ensure a consistent clinical effect through all tissue types.

You can use handpiece or footswitch controls to activate the generator.

Receptacles are marked to ensure the correct connection of accessories.

Indicators alert you when the generator is activated.

Plate disconnection alarms are available through the use of a single patient plate.

A no-plate alarm is also present to prevent monopolar activation by mistake.

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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 x SEAL generator
  • 10 x EEMDESUA401: V11MCT9N Handpiece TACTILEC 4 m cable, tripins plug, chuck for electrode diam. 2.4mm, reusable
  • 1 x EEMDESUS1001: V11F3AX Power cable 16A/250V, 3 x 1mm², 5.50 m​
  • 3 x EEMDESUA403: V11IS1C Patient return electrode silicone, monopolar, adult + cable 5m reusable
  • 6 x EEMDESUA402: 11CCDI Set of 5 short electrodes Ø 2.4mm, cutters, insulated, straight, length 65mm, reusable
  • 2 x EEMDESUA1005: V11CD2L Set of 5 long electrodes, cutters, insulated, straight 20mm, length 120mm, reusable
  • 50 x EEMDESUC404: VPLAD2 Double-surface adhesive plate, adult, single-use
  • 50 x EEMDESUC1001: VPLEN2 Double-surface adhesive plate, child, single-use
  • 2 x EEMDESUA405: V11K250 Cable/connector UNIPLAC 5 m for single-use adhesive plate, conn.22x28mm

Technical specifications

Electrosurgical system generator

The generators have double insulation to isolate the high-frequency current applied to the patient in its own current loop. The current is therefore distributed through the handpiece and returns through the patient's return electrode to the generator.

Operating conditions

  • Temperature range: 10°C to 40°C (50°F to104°F)
  • Relative humidity: 30% à 75%
  • Atmospheric pressure: 700 à 1060mbar

Input

  • Power supply: 220-240V, 50-60 Hz
  • Maximum power:1200 VA

Output

  • Waveform: pure sinewave and pulsed sinewaves
  • Frequency emitted: 450 KHz
  • Modulation frequency: 21 KHz
  • Monopolar Cut
    • Autocut: max power 360 W / 250
      • Pure cut:
      • Blend 1
      • Blend 2
      • Endosection
    • Forced cut ​(with hemostasis)​
      • Forced pure cut
      • Forced blend 1
      • Forced blend 2
      • Endosection

Dimensions

the generator:

  • Length x Width x Height: 44 x 36 x 11 cm
  • Weight: 8.2 kg

Supplied with the Article

  • 100 x CLEANING PAD for electrosurgical tip, 5x5cm, sterile SSCOETCP55
  • 25 x EEMDESUC1001: VPLEN2 Double-surface adhesive plate, child, single-use

To be Ordered Separately

  • EEMDESUC1002: VPLBB2 SPLIT PATIENT RETURN ELECTRODE, neonate s.u.
  • EEMDESUA1004: VPB20D10 BIPOLAR ELECTRODE straight, reusable
  • EEMDESUA1002: V11F242 CABLE FOR BIPOLAR ELECTRODE reusable
  • EEMDESUA414: V11SM2FN BIPOLAR FOOTSWITCH, double

Instructions for use

Three cut modes, all controlled by Instant Response™ technology, offer surgeons a variety of choices

  • Low Cut for delicate tissue or laparoscopic cases
  • Pure Cut for a clean, precise cut
  • Blend for cutting with hemostasis

Four coagulation modes

  • Desiccate for low voltage contact coagulation suitable in laparoscopic and delicate tissue work
  • Fulgurate (high crest factor) for efficient noncontact coagulation in most applications
  • Fulgurate (low crest factor) for lower voltage coagulation requirements
  • Spray for coagulating large tissue areas with superficial depth of necrosis

Three bipolar modes

  • Precise, Standard, and Macrobipolar are controlled by the Instant Response™ system
  • Precise and Standard settings utilize low voltage to prevent sparking

An optional Thermocision mode

Precautions 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).

CAUTION, DANGER OF BURN:

  • if the contact surface between the return electrode and the patient is too small (current concentration)
  • If the plate is poorly adhered to the patient's skin and causes a sharp angle restricting the passage of current and thus creating heat which can even provoke burns.
  • if the plate is not always dry (liquids are electric conductors)

MSF requirements

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

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