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  3. (MC2/SEAL) SPLIT PATIENT RETURN ELECTRODE,neonate,s.u.VPLBB2
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(MC2/SEAL) SPLIT PATIENT RETURN ELECTRODE,neonate,s.u.VPLBB2

https://msf.oodin.sh/cat/product/79803
STD EEMDESUC1002

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
Z12010985 - Electrosurgery instruments – consumables
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
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) SPLIT PATIENT RETURN ELECTRODE, s.u.

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.

Because of frequent patient burns at pad sites, the RECQM (Return Electrode Contact Quality Monitoring) system was developed. The generator has a microprocessor that monitors the quantity and quality of contact the return electrode makes with the patient. Monitoring return electrodes are easily identifiable: they have a split foil surface as opposed to a large single sheet of foil on the pad. With the RECQM system, if electrode contact is interrupted the generator will alarm and deactivate.

Synonym

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

Specifications

Technical specifications

Flexible sticky pad: a polymer covers the conductive foil: the adhesive edge is needed to hold the pad in direct contact with the patient's skin, lowers skin resistance and fills patient skin irregularities.

Sterile and single use

3 sizes:

  • For adults (body weight of > 15 kg) EEMDESUC404
    • contact surface = 140 cm²
    • total surface = +/- 180 - 200 cm²
  • For children (body weight of 5 – 15 kg) EEMDESUC1001
    • contact surface = 70 cm²
    • total surface = 100 - 130 cm²
  • For neonates (body weight < 5kg) EEMDESUC1002
    • contact surface = 40 cm²
    • total surface = +/- 70 cm²

To be Ordered Separately

EEMDESUA1003: an additional connecting cable to secure the connection between a SPLIT return electrode and the generator (cable with REM-pin connector).

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.

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.

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