Neutral Electrode Instructions for Use

Attention Please read the information in this leaflet carefully. Improper handling and care, as well as unintended use may cause premature wear or risks to patients and users. Intended use The neutral electrodes must only be used by trained, medical staff instructed in use of this product.

NEUTRALELECTRODE

The neutral electrodes are intended for any monopolar surgical intervention and service discharge of the HR current when working with HF devices. They are not intended for direct contact with the heart or central vascular system. The neutral electrodes are connected to the neutral electrode connection of the electrosurgical generator via an HF cable. We recommend a fuel gas extraction in HF surgery. The maximum accessory rated voltage must not exceed a voltage of 4300 Vp. In combination with other HF accessories, the maximum accessory voltage corresponds to the smallest accessory rated voltage.

ENGLISH

NEUTRAL-ELECTRODE

INSTRUCTIONS FOR USE

89232003 - 89242005

Safety note The maximum rated voltage of the neutral electrodes can be taken from these operating instructions, the label or the current product catalogue. New rubber neutral electrodes must be cleaned before commissioning (see item "Cleaning"). Before any use, a function test must be performed (see item "Function test"). Ensure that the neutral electrode is correctly connected to the generator and attached to the patient (see item "Attaching the neutral electrode)). Proceed with care to avoid damage to the neutral electrode and/or injury to the patient or the surgical staff. The neutral electrode must only be used in persons with body weight of 11.5 kg or more. Observe that no flammable substances must be in direct proximity during the entire application, since there is a danger of explosion otherwise. The application of HF current may cause damage to pacers and defibrillators. Therefore, affected patients must consult a cardiologist before the intervention. Cleaning Due to the product design, the materials used and the purpose, a defined limit of maximum possible preparation cycles cannot be specified. Instruments for electrical surgery are naturally subject to increased wear depending on the type and duration of the application.

Günter Bissinger Medizintechnik GmbH Hans-Theisen-Str.1 79331 Teningen Germany Tel.: +49 7641 9 14 33 0 Fax: +49 7641 9 14 33 33 Email: [email protected] www.bissinger.com

HH-8923_Neutral-Elektrode_vB - EN.docx Revision B 10.11.2021/MG

Spray or wiping disinfection is not sufficient. Cleaning preparation: Remove the rubber neutral electrodes from their packaging. Disassembly of the rubber neutral electrode is not possible or necessary.

Manual cleaning: The rubber neutral electrodes must be disinfected right before and after every use. The rubber neutral electrodes should be thoroughly cleaned with a soft brush or a plastic fleece and flushed, since particles or dried secretion may

otherwise adhere to them. This may make later cleaning and sterilisation difficult or even impossible. Ensure that areas that are difficult to access are thoroughly cleaned and multiply flushed. Highly alkaline cleaning with pH values above 10 and below 13 do not have any harmful influence on the service life. Cleaning of the device: Machine cleaning is prohibited. This may cause failure after just a few cycles. Disinfection: The neutral electrodes are disinfected by spray or wiping disinfection. Limitation of preparation: The product service life depends on wear, damage and frequency of cleaning and disinfection. Attaching the neutral electrode Place the neutral electrode on a level muscular or well-vascularised skin area near the area of surgery. The current path between the electrodes should be as short as possible but not undercut a distance of 20 cm. Also choose this area so that as little liquid as possible or, if possible, no liquid at all, can reach this area. In an adult person, best use an arm or thigh. Before applying the neutral electrode, the selected area must be shaved, cleaned thoroughly and dried. Now the function test must be performed. The neutral electrode must be applied with the long edge vertical to the power direction, i.e. the flowing current will hit the long edge of the neutral electrode first. The neutral electrode must be firmly attached to the location described above with two rubber straps. To check the even seat of the neutral electrode, run your hand over the neutral electrode with slight pressure. Then connect the neutral electrode to the device using the corresponding cable. After use, the cable is disconnected from the device again. Now remove the neutral electrode from the patient carefully. Function inspection Before every use, check the insulation of the neutral electrodes for pressure points or damage. Neutral electrodes with damage or pressure points must not be used. Repair and modification Defective neutral electrodes must not be repaired. They must be replaced by new neutral electrodes. Independent modification and repair are strictly prohibited and will cause loss of the manufacturer's warranty. Packaging, storage, transport, handling The neutral electrodes must be kept in a clean and dry environment. They should be kept individually in a protective container with single compartments or welded into foil. The neutral electrodes must be treated with the greatest care when transporting, cleaning, during maintenance, sterilisation and storage. Maintenance of the sterile condition after sterilisation must be warranted by the operator. Returns Returns are only accepted if they are marked as "hygienically harmless" or "not decontaminated" and safely packed for shipping.

Disposal Disposal of the neutral electrodes, the packaging material and accessories must take place according to the respective applicable countryspecific provisions and laws. About these operating instructions The operating instructions must be kept freely accessible for each user for the period of use of the neutral electrodes. Warranty Günter Bissinger Medizintechnik GmbH delivers only inspected and defect-free products to its customers. All of our products are designed and produced to meet the highest quality standards. Liability for products modified as compared to the original, used for any other purpose or treated or used improperly is excluded. Explanation of symbols used

Batch number

Attention: Unsterile product

Order number

ATTENTION!

Observe operating instructions

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