RUDOLF Medical GmbH

Bone Rongeur Forceps Instuctions for Use

4 Pages

INSTRUCTIONS FOR USE (EN) D0820 / Rev.B / DCR00787  Bone Rongeur Forceps  Bone Rongeur Forceps  Item numbers See page 4. Indication Bone Rongeur Forceps are used if the bone must be kept, temporarily fixed, or bone parts have to be removed. Description The device consists of a handle with rings or branches and a jaw part. By pressing the handle or the branches together, the jaw part closes. The jaw part is strong enough for bones. It has a closing mechanism without locking and they have partly a double translation There are different sizes and models available. Lifetime The useful life of the instrument is limited to handling of the device. Bending or overloading causes damages. Careful reprocessing and easy handling ensures more than 1000 operations. If the jaw part is blunt or there are pores or cavities visible, then you must stop using the instruments.  Function check Following delivery and before each use new instruments must undergo a thorough visual examination and must be tested for functionality. If the instrument exhibits any external faults (scratches, breakages, cracks, notches, damaged insulation, bent parts or stiffness) or if they do not function in the way described, please inform us as manufacturer or our sales partners immediately. Warnings and precautions - Do not use damaged instruments. - The instrument has only a limited stability. Force applied too strongly can lead to damage and negatively affects it’s functioning. First use of new instruments - The instrument is delivered non-sterile. It must be cleaned and sterilized before the first use. Warnings and precautions - During preparation, the temperature affecting the instrument must not exceed 137°C, - Automatic cleaning and disinfection is to be preferred to manual cleaning and disinfection. The automatic cleaning and disinfection procedure is much safer.  - Never use metal brushes/sponges or abrasive cleaning agents for manual cleaning. - Only clean instruments and instruments of low microbiological contamination enable a successful sterilization. - In case of damage the devices should undergo the complete reprocessing process before being sent back to the manufacturer for repair. - Never use cleaning agents with bleaching agents, such as sodium hypochlorite, as it causes severe corrosion.  Robert-Koch Insitute (RKI) of the DGHM Deutsche Gesellschaft für Hygiene und Mikrobiologie (German society for hygiene and microbiology) and consider the instrument’s material and characteristics. See additional information of the preparation instructions at hand.  Application area - After use, the instruments must be prepared as fast as possible. - Remove residues and stains on the instrument immediately after use with a single use cloth or tissue. - Do not use a fixating agents or hot water (>40°C) as this can cause the fixation of residues which may influence the result of the reprocessing process. - Deposit them preferably in a dry place. - If necessary; soak the instruments in a solution with a suitable combination of cleaning and disinfecting agents. Please, observe the manufactures’ instructions of the cleaning and disinfecting agents. - Put the instruments in suitable wire baskets.  *the suitability of the cleaning agent as well as subsequently described method has been demonstrated based on preclinical testing / validation by RUDOLF Medical.  Transportation - Safe storage and transportation in a closed container to the reprocessing area to avoid any damage of the instruments and contamination of the environment. Cleaning Automated cleaning - Clean and disinfect the instrument only in suitable washers and disinfectors (WD) and with for the WD and the instrument validated procedure / program according to EN ISO 15883. - Suitable WDs are provided with special cleaning baskets / slide-in carts for sensitive instruments. - Avoid any rinsing shadows when loading the WD slide-in cart with instruments in order to obtain an ideal rinsing pressure for the entire instrument. Pay special attention to the jaws. - Do not overload the WD slide-in carts, do not pile them up. - Please observe the instructions for use and loading indications of the WD manufacturer. - When choosing the appropriate cleaning agents see the respective lists and recommendations of the  Cleaning agents for automatic cleaning in WD Manufacturer Trade name Dr. Weigert GmbH & Co. KG Neodisher FA Borer Switzerland Deconex 23 Neutrazym  A - Cleaning program (Miele G 7735) - 1 min. pre-cleaning with cold water - Draining - 3 min. pre-cleaning with cold water - Draining - 5 min cleaning at 55°C with 0,5 % alcaline detergent - or 5 min cleaning at 45°C with 0,5 % enzymatic detergent - Draining - 3 min. neutralization with warm water (>40°C) and neutralizer - Draining - 2 min. rinse with warm tap water (>40°C) - Draining Maintenance, Control and Inspection - After the cleaning and disinfection, the instruments must be inspected visually for cleanness. They must be macroscopically clean (no visible residues/soiling). Pay special attention to grooves, ratchets, closures and other difficult accessible areas. - Should there still be any visible residues or liquids repeat the cleaning and disinfecting procedure. - Prior to any sterilization the instruments must be assembled and inspected for function, wear and tear and for damages, and if necessary it has to be exchanged. After the inspection, dismantle the instrument if necessary for sterilization. - The lock must be oiled with medical grade white oil (RUDOLF RU 8880-03)  Page 1 of 4
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