Monopolar and Bipolar HF Cables Instructions for Use

WARNINGS AND PRECAUTIONS Improper use can lead to hazardous situations.

INSTRUCTIONS FOR USE (EN) MONOPOLAR AND BIPOLAR HF CABLES

An incorrect combination of products can lead to injury of patients, users, or third parties as well as to product damage. -

RUDOLF Medical GmbH + Co. KG Zollerstrasse 1, 78567 Fridingen, Germany Phone: +49 7463 9956-0 Fax: +49 7463 9956-56 [email protected] www.RUDOLF-med.com D1223 / Rev A / ACR00333 / 2022-04-20

PLEASE READ BEFORE PROCESSING AND KEEP IN A SAFE PLACE INTENDED PURPOSE HF surgery cables are intended to transmit electrical current from the output of a HF generator to the instrument or to the connector of a neutral electrode at the generator. The cables must be used only with compatible HF generators and instruments. The combination possibilities depend on the corresponding connection types at the generator and instruments.

Instruments and cables for HF surgery must only be used by trained or qualified personnel. In the case of patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of this disease, the applicable national regulations regarding the preparation of instruments must be applied.

Connection and Activation - Before using monopolar instruments, ensure that a designated HF neutral electrode is correctly attached to the patient and properly connected to the designated HF generator. This does not apply to bipolar applications. - When connecting the cable make sure that the HF generator is switched off or in standby mode (where applicable). - When combining with other HF accessories, make sure to avoid output settings on the HF generator where the maximum output voltage may exceed the rated accessory voltage listed below. - Failure to observe these warnings and precautions may result in injury, malfunction, or other unexpected occurrences. - Improper use will result in immediate loss of warranty. No liability will be accepted for any damage caused by improper handling. - Prior to each use, the cables must undergo a visual and functional inspection. - Make sure that the correct connection at the generator or instrument is selected and that the cable is completely plugged in. - Never use damaged cables. - Do not kink the cables or wind them too tightly to avoid cable breakage. - Always unplug the HF cables by the plug and never by the cable to avoid damage. - Do not use the cables in the presence of flammable or explosive substances.

Combinability / Compatibility - Before use, make sure that the product is compatible with the HF accessories and the HF generator intended for the procedure. - The HF cables must never be connected to different or unknown power sources. The instructions, safety, and warning notes in the operating instructions of the accessories and HF generator used must be followed. Other Important Notes: Maximal Rated Accessory Voltage (Umax)

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Product

Umax

Monopolar HF cables

4.3 kVp

Bipolar HF cables

0.8 kVp

Neutral electrode cable

4.3 kVp

When combined with other HF accessories, the maximum rated accessory voltage of the system is equal to the lowest rated accessory voltage of the individual products. The maximum rated accessory voltage of the product can be found in these instructions for use, on the label or in the current product catalogue. If you have any questions, please contact RUDOLF Medical. Before use, the entire instructions for use of this product and any accessories used, as well as of the HF generator and HF neutral electrode (monopolar application) must be observed. The specifications, safety instructions and warnings in the respective instructions for use must be observed and followed.

REPROCESSING INSTRUCTIONS Products are delivered in a non-sterile state and must be cleaned, disinfected, and sterilized before the first and any other subsequent use. Restrictions - Due to the product design, the materials used and the intended purpose, it is not possible to provide a maximum number of possible reprocessing cycles. - The service life of the products is determined by their function and the careful handling of them. Initial Treatment at the Place of Use - The products must be reprocessed within 1 hour after use, to prevent dirt from drying on the products. - Heavy soiling on the instrument must be removed with a disposable rag, cloth, or tissue immediately after use. - Do not use any fixing agents or hot water (>40°C), as this leads to the fixing of residues and can affect the success of the cleaning procedure.

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Do not use any fixing agents or hot water (>40°C), as this leads to the fixing of residues and can affect the success of the cleaning procedure.

Transportation - Safe storage and transportation of the instruments to the reprocessing site in a closed receptacle / container system to avoid damage to the instruments and contamination to the environment. Automated Cleaning and Disinfection - Clean and disinfect the cable only in suitable washers and disinfectors (WD) and with a procedure / program validated for the WD and this type of cable (EN ISO 15883). - The operating and loading instructions of the WD manufacturers must be observed. - When choosing the cleaning agent, please observe the material and properties of the instrument, the cleaning agents recommended by the WD manufacturer for the respective application and the relevant lists and recommendations of the Robert Koch Institute (RKI) and of the German Society for Hygiene and Microbiology (DGHM, Deutsche Gesellschaft für Hygiene und Mikrobiologie). Detergents for the automated cleaning in a WD Process

Detergent

pH value

Manufacturer

Alkaline

neodisher® FA

12.2

Dr. Weigert

Enzymatic

deconex® 23 Neutrazym

9.7

Borer

Automated cleaning with thermal disinfection in a washer/disinfector with an alkaline or enzymatic detergent Process

Reagents

Time / Min.

T / °C

Pre-wash

Water

1

Cold

Water

3

Cold

Draining Pre-wash Draining Cleaning

Water, 0.5% alkaline detergent OR

55 5

Water, 0.5% enzymatic detergent

45

Draining Neutrali-zation

Water

3

Cold

Water

2

Cold

Draining Rising Draining

D1223

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