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ELECTRO SURGICAL UNIT (Valleylab Force FX), 220 V + acc.

https://unicat.msf.org/cat/product/53618
NST EEMDESUE6--

Outdated Article

Former Code(s): EHOEZNL0373 EHOEZFR0686
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.
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.
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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ELECTROSURGICAL UNIT (Force FX)

Stopped in 2019 because no longer manufactured. Replacement by Lamidey SEAL (see “replaced by” at bottom of the page).

Definition

An assembly of devices 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

The assembly includes

  • a mains electricity-powered RF generator with monitoring functions/controls
  • connection cables
  • a handpiece with electrodes to apply the energy to the surgical site
  • a patient return electrode is necessary for monopolar electrosurgery

Specifications

The Valleylab Force FX™ is an isolated output electrosurgical generator that provides the power for cutting, desiccating, and fulgurating tissue during surgery. The generator is used for bipolar and monopolar electrosurgical procedures.

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.

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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 Mains electricity-powered RF generator with monitoring functions/controls connection cables
  • 10 x HANDPIECE with switch & cable, reusable E2100 EEMDESUA603
  • 3 x PATIENT RETURN ELECTRODE, adult, reusable EEMDESUA606
  • 2 x PATIENT RETURN ELECTRODE, child, reusable EEMDESUA610
  • 3 x RUBBER BAND, with fixation button
  • 3 x CABLE FOR REUSABLE PATIENT RETURN ELECTRODE, EEMDESUA607
  • 4 x CABLE for SPLIT PATIENT RETURN ELECTRODE E0560 EEMDESUA605

Technical specifications

Electrosurgical system generator

Isolated generators isolate the current from ground and do not allow significant current to seek alternate paths to ground. The current must return through the patient return electrode to the generator.

  • Operating parameters:
    • Temperature range: 10°C to 40°C (50°F to 104°F)
    • Relative humidity: 30% to 75%
    • Atmospheric pressure: 700 to 1060mbar
  • Input
    • Operating range is 85 to 132 AC volts.
    • Maximum current is 7 amperes in "Cut" and 4 amperes in "Coagulation"
  • Output:
    • Bipolar
      • Precise: 470 kHz sinusoid
      • Standard: 470 kHz sinusoid
      • Macro: 470 kHz sinusoid
    • Monopolar Cut
      • Low: 390 kHz sinusoid. Similar to the Pure Cut mode except the maximum voltage is limited to a lower value.
      • Pure: 390 kHz sinusoid
      • Blend: 390 kHz bursts of sinusoid, recurring at 27 kHz intervals. 50% duty cycle envelope.
    • Monopolar Coagulation
      • Desiccate: 240 kHz sinusoid repeated at 39 kHz. 8% duty cycle.
      • Fulgurate: 390 kHz damped sinusoidal bursts with a repetition frequency of 30 or 57 kHz into 500 ohms
      • Spray: 390 kHz damped sinusoidal bursts with a randomized repetition centered at 28 kHz. Frequencies include 21kHz < f < 35 kHz. Output is further modulated by a random 250 Hz envelope with a variable duty cycle. Output power changes by less than 15% or 5 watts, whichever is greater, as the line voltage varies from 104-132 volts and 208-264 volts (at rated load).

Dimensions

the generator:

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

Supplied with the Article

  • 150 x MONOPOLAR BLADE ELECTRODE, 6cm s.u. E1551G EEMDESUC605
  • 50 x MONOPOLAR BLADE ELECTRODE, 16cm s.u., E1551-6 EEMDESUC606
  • 100 x CLEANING PAD for electrosurgical tip, 5x5cm, sterile SSCOETCP55S

To be Ordered Separately

  • EEMDESUC601 SPLIT PATIENT RETURN ELECTRODE, adult s.u.
  • EEMDESUC603 SPLIT PATIENT RETURN ELECTRODE, child s.u.
  • EEMDESUC604 SPLIT PATIENT RETURN ELECTRODE, neonate s.u.
  • EEMDESUA611 BIPOLAR ELECTRODE BAYONET, 2mm reus. E4054-CT
  • EEMDESUA612 CABLE FOR BIPOLAR ELECTRODE reusable E0020V
  • EEMDESUA613 BIPOLAR FOOTSWITCH, standard E6009B

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

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 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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