(MC2/SEAL) RETURN ELECTRODE,mono,adult+cable 5m,reus.V11IS1C

STD EEMDESUA403

Valid Article

Former Code(s): EHOEELSU403
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.
Z12010980 - Electrosurgery instruments – hardware accessories
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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(ESU) PATIENT RETURN ELECTRODE, reusable

Definition

A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. The return electrode is necessary for monopolar electrosurgical functions.

Synonym

Bovie pad, grounding pad, safety pad and patient return pad.

Specifications

  • Material: conductive silicone
  • Non sterile
  • 1 size: for adults (body weight of > 15 kg)
    • +/- 25x15cm, contact surface = 375 cm²= total surface
  • Connecting cable length: varies according to manufacturer: 50 - 500 cm

To be Ordered Separately

  • A rubber band to attach the return electrode firmly to the patient (EEMDESUA608)

Instructions for use

  • Select the site for application of the return electrode so that the current paths between the active and return electrode are as short as possible and run lengthwise or diagonally to the body.
  • Apply the return electrode on the closest upper arm or upper leg, depending on the operating field, but no closer than 20 cm.
  • The application site must be dry, shaven, clean (do not use alcohol to clean as this dries out the skin) and free from metal jewelry.
  • The return electrode must not be applied to damaged or injured skin, no ECG electrodes or implants (bone pins or plates) are in the path of the current, ensure that the patient's heart is never in the path of the current.

Precautions for Use

  • The return electrodes may be used only by trained medical personnel.
  • Use only return electrodes that are compatible with your HF generator.
  • Make sure that the return electrode is in perfect condition before application. If there is any damage, the defective part may no longer be used. Repair is not permitted.
  • The return electrodes are ready to use. Do not use any additional contact gel.
  • Check the return electrode regularly, and after moving the patient, to ensure that the entire surface makes contact. If a return electrode is partially pulled off, it can cause damage to the skin.

Maintenance

Can be cleaned and disinfected with a 0.5% detergent-disinfectant solution for medical equipment (i.e. 25 ml = 1 stroke of dosing pump for 5 litres water).

Do not soak in a liquid.

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