RUDOLF Bipolar Forceps Instructions for Use

account the safety and warning instructions given in these instructions for use.

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INSTRUCTIONS FOR USE (EN) BIPOLAR FORCEPS

Incidents that have been reported in connection with the use of electrosurgical systems: - Unintended activation with resulting tissue injury in the wrong location and/or damage to the equipment. - Fire in connection with surgical drapes and other inflammable materials. - Alternating current paths leading to burns on spots where the patient or user comes into contact with components without insulation. - Explosions caused by sparks in the proximity of inflammable gases. - Perforation of organs. Sudden severe bleedings.

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RUDOLF Medical GmbH + Co. KG Zollerstr. 1, 78567 Fridingen, Germany Tel. +49 7463 9956-0 Fax +49 7463 9956-56 [email protected] www.RUDOLF-med.com D0163 / Rev I / ACR00291 / 2022-07-29

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PLEASE READ BEFORE USE AND KEEP IN A SAFE PLACE INTENDED USE The Bipolar Forceps are designed to grasp, dissect and coagulate selected tissue during open surgical procedures. They must be connected to the bipolar output of an electrosurgical generator using a suitable bipolar cable and must only be used with parameters for bipolar coagulation. Do not exceed a maximum output of 300 Vp (HF510-011 – 511-511) 500 Vp (HF515-015 – HF533-722) of your generator. CONTRAINDICATIONS - Do not use the instrument if, in the opinion of the attending physician, the risks to the patient outweigh the benefits. - The Bipolar Forceps are not effective for tubal sterilization, coagulation of the fallopian tubes, etc. - Since the safe and effective use of bipolar forceps strongly depends on factors such as tissue type, pathology and surgical procedure, the above information can only be used as a general guidance. The clinically successful application is dependent upon the knowledge and experience of the surgeon, who is responsible for deciding which structures can be reasonably treated and whether the patient’s condition, e.g., the coagulation status, allows a successful treatment while taking into

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WARNINGS AND PRECAUTIONS The Bipolar Forceps may only be used by surgeons who have been trained in the usage of the products and who have the required knowledge and experience for the specific surgical procedures. When using electrosurgery in patients with pacemakers or other active implants, special requirements apply (e.g., low HF current, patient monitoring) In any case, a cardiologist or appropriate medical specialist must be consulted. Activate electrosurgical current only if the contact areas are in full view and have good contact with the tissue that needs to be treated. Do not touch any other metallic instruments, trocar sleeves, optics or similar objects during use. When temporarily not in use, the instrument must be placed electrically insulated from the patient. Never use the instruments in the presence of flammable or explosive substances. Follow all safety precautions and instructions supplied by the manufacturer of the electrosurgical generator. RUDOLF Medical instruments must be cleaned, disinfected, and sterilized before first use. Protective caps and transport packaging must be removed beforehand. A complete functional check must be carried out before each use. Check for damage and wear, in particular for insulation defects. Never use damaged instruments. Improper use and overstraining due to twisting / levering can lead to breaks and permanent deformation. Do not use metal brushes or abrasives, as there is a risk of corrosion due to surface damage. The safe combination of instruments with each other or with accessories must be checked by the user before clinical use. Be careful when handling sharp tips and cutting edges risk of injury. In the case of patients with Creutzfeldt-Jakob disease (CJK), suspected CJK or possible variants of this disease, the applicable national regulations regarding the preparation of instruments must be applied.

Never leave instruments in disinfectant solution too long. Follow the instructions of the respective manufacturer. Automated cleaning / disinfection should be preferred to manual cleaning / disinfection, since automated processes can be standardized, reproduced and thus validated.

PRIOR TO EACH USE: VISUAL AND FUNCTIONAL INSPECTION Check for: - External damage (shaft deformed, dents or sharp edges) - Correct functioning - Detergent or disinfectant residues - Free passage through working channels. REPROCESSING INSTRUCTIONS Restrictions - Repeated / frequent reprocessing according to these instructions has only little effect on the durability of the instruments. - The durability of a reusable instrument is essentially determined by wear and damage caused by the application. Initial treatment at the place of use - The instruments must be reprocessed within 1 hour after use, to prevent dirt from drying on the instruments. - Heavy soiling on the instrument must be removed with a disposable rag, cloth, or tissue immediately after use. - Working channels and lumens must be flushed through at least 3 times immediately after use to avoid blockages. - 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. - Defective instruments must be identified and clearly marked. They are also to be reprocessed. Transportation Safe storage and transport 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 - Clean and disinfect the instrument only in suitable washers and disinfectors (WD) and with a procedure / program validated for the WD and this type of instrument (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 Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM, German society for hygiene and microbiology). Detergent for automated cleaning in washers and disinfectors (WD) Process Type

Detergent

pH value

Manufacturer

Alkaline

Neodisher® FA

12.2

Dr. Weigert

7

Ruhof

Enzymatic Endozime

Automated cleaning program with thermal disinfection in the WD using an alkaline OR enzymatic process

Water

Time / min 1

T / °C cold

Water

3

cold

Water, 0.5 % alkaline detergent OR Water, 0.5 % enzymatic detergent

5

Water

3

Warm tap water (>40°C)

Process

Reagents

Pre-cleaning Drain Pre-cleaning Drain

Cleaning

55 45

Drain Neutralization

Preparation for decontamination - The instruments must be disassembled or opened for reprocessing as far as possible without using tools.

Drain Rinsing

Water

2

Warm tap water (>40°C)

Manual pre-cleaning - Before automated cleaning in case of heavily encrusted soiling, cleaning must be carried out in the ultrasonic cleaning bath with 0,5 % enzymatic cleaning detergent (cleaning solution < 40 ° C, sonication time min. 15 min.). - Remove the instrument and rinse them completely with cold water to remove the cleaning detergent. - Observe the manufacturer’s instructions for the cleaning agent (concentration, temperature, and sonication time).

Drain Disinfection * Drying **

Demineralized water

>5 > 20

> 90 max. 93

* Carry out mechanical thermal disinfection by considering the national requirements regarding the A0 value from ISO 15883-1 (A0 = 3000). ** If necessary, manual drying with a lint-free cloth can also be carried out. Dry instrument cavities with sterile compressed air.

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