Instruction Guide Re-Usable Surgical Instruments. Instruction Guide Re-usable surgical instruments (GA 30.1)

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Violet Cummings
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1 Instruction Guide Re-usable surgical instruments (GA 30.1) Part A: General Information 1. Field of application 2. Basics 3. General 4. Construction and Material 5. Compatibility 6. Labelling label symbols 7. Disposal; return consignment 8. Warranty 9. Manufacturer Service contact 10. Norm - References Part B: Information of the treatment 11. General basics for hygiene and treatment 12. Mechanical cleaning and thermal disinfection 13. Control and maintenance 14. Packaging 15. Sterilization 16. Storage and treatment of instruments 17. Confirmation - notices Part C: Application 18. General application Part A: General information 1. Field of application This instruction guide is valid for all re-usable surgical instruments, that A: consist of only one piece B: may contain simple joints or simple movable parts C: may be composed of several exchangeable parts (e.g. Bone Mill) Products that are connected to an active apparature or operated by their own energy are excluded of this instruction guide. 2. Basics This instruction guide can t replace training, carefulness and user s knowledge of technology.we therefore put the relevant legislation, standards and recommendations (e.g. RKI2 or AKI1) assumed to be known (see "Standards / References") and therefore limit ourselves to be observed by the user for each instrument instructions and information which are of importance for our products. Reasons for these statements and the consequences for non-compliance risks are set out in the legislation and recommendations. Instruments are generally delivered non-sterile! After receipt, please check identity, completeness, integrity and function before bringing the instruments for treatment. Before every use of instruments, please prove them for cracks, deformations, damages and functional efficiency. Following sectors need especially careful inspection: Blades, tips, closures, locks, ratchets and all movable parts. Worn, corroded, deformed, porous or otherwise damaged instruments must be sorted out. ATTENTION! Read this instruction very carefully, before use and treatment of the product! 1 / 6

3. General Ortho Select guarantees for the quality of construction and material of the product. For our instruments only steels according DIN EN ISO 7153-1 are used for medical instruments.

The instruments may be used exclusively for its intended use in the medical fields by appropriately trained and qualified personnel.

2 3. General Ortho Select guarantees for the quality of construction and material of the product. For our instruments only steels according DIN EN ISO are used for medical instruments. Plastics for medical products are approved and tested for biocompatibility. The instruments may be used exclusively for its intended use in the medical fields by appropriately trained and qualified personnel. Responsible for the selection of instruments for specific applications or the operational use, the appropriate training and information and sufficient experience for the handling of the instruments is the attending doctor or user. 4. Construction and Material The instruments are designed according to the latest instrument technology and to the best available technology. Safety and functioning can only be guaranteed, if instructions of operation manual and hints in this instruction are considered and followed. Full details are described in the available literature. 5. Compatibility The instruments are available in many shapes and sizes and are made out of different materials. Instruments can be combined (e.g. Locking pliers and slap hammers), but this is only possible with other SMT-Products and only when it is given and released by SMT. A combination of SMT-Products with third-party products excludes from any warranty and guarantee. When reassembling after disassembly, separate parts cannot be replaced by other manufacturers! If there are interchangeable parts, by the intended use of the product, (e.g. different work inserts in bone mill) no other manufacturers may be used! We recommend also referring other accessories (e.g. maintenance products) from Ortho Select. 6. Labelling label symbols REF Item or order number Batch number NOT STERILE Indication for NON sterile products Caution, note attached documents Caution, note instruction guide European approval symbol GA31.1 accompanying Instruction for use (e.g. No. GA e) Attached or viewed on Attention! For sterile delivered products is valid: If sterile packaging is damaged (e.g. Cracks, slices, breakages, etc.), the product is not allowed to be used. Products with above listed faults must be marked (note for damaged sterile-packaging) and send back to Ortho Select. 7. Disposal; return consignment Ortho Select GmbH only accepts returns if the products are declared as hygienically safe (treated with disinfection processes), if they are marked as not decontaminated and if they are safely packed. After successful disinfection, defective or obsolete instruments must be disposed professionally or supply a recycling system. 2 / 6

3 8. Warranty Safety note: The responsibility for proper cleaning, disinfection and sterilization of instruments is incumbent upon the customer / product user. National arrangements, including limitations thereto, must be followed carefully. Ortho Select delivers exclusively tested and faultless products to their customers. All our products are designed and manufactured to meet the highest quality standards. Ortho Select as a manufacturer of products excludes from any warranty claims and assumes no liability for direct or consequential damages caused by: - incorrect usage - improper use, application or handling - after usage on patients with Creutzfeldt-Jacob-Disease (CJD) or its variants, we refuse any Responsibility for re-usage! We recommend destruction of instruments. A treatment and reuse also in accordance with the Directive RKI2 done entirely on their own responsibility! - improper treatment and sterilization - improper maintenance and repairs - failure to follow this instruction guide Repairs may only be carried out by authorized Ortho Select companies or individuals. Foreign-throughs result in the exclusion of all warranty claims. 9. Manufacturer Service contact Failure to understand this instruction may result in: - Death or severe injury to the patient - Severe injury to the user - damage to the equipment Please contact us for any uncertainties, disagreements or questions arise, before the product is used or treated again. Ortho Select GmbH Eltastrasse Wurmlingen Germany Tel: +49(0) Fax: +49-(0) Mail: info@ortho-select.de 10. Norm - References - AKI1-guide Instrumenten-Aufbereitung richtig gemacht - RKI2-recommendation: Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten - DIN EN 285 Large-steam-sterilizer - DIN EN Small-steam-sterilizer - DIN EN ISO Cleaners Disinfectors - DIN EN 868/ ANSI AAMI ISO Packaging materials - DIN EN ISO Sterilisation Manufacturer s information - DIN EN ISO (or DIN EN 554/ ANSI AAMI ISO 11134) Sterilization process Wet heat - 1 AKI: Arbeitskreis Instrumenten-Aufbereitung - 2 RKI: Robert-Koch-Institut 3 / 6

4 Part B: Information for treatment 11. General basics for hygiene and treatment Manual pre-cleaning: Equipment: Cleaning-brush out of plastic, Water jet gun (Aquajet) Hygiene at working area: Here the effective hygiene measures are in accordance with country-specific requirements. Please note the water quality in accordance with DIN EN 285, Appendix B. 1. Disassembling of all removable parts. Pay attention to material and instrument proper handling and storage! 2. Place all parts for at least 10 minutes in neodisher LM 2 and press all moving parts at least 5 times. 3. Brush parts carefully until no contamination (blood, tissue adhesions) is more visible. 4. Treat parts additionally in an ultrasonic bath (concentration neodisher LM ml/l*1). 5. Through rinsing with cold, demineralized tap water, remove residues of detergent. With the water jet gun down all surfaces and cavities thoroughly (min. 1 minute) and press any moving parts at least 5 times. 12. Mechanical cleaning and thermal disinfection Equipment: Washer-disinfector (WD) from Miele with Vario TD program. Neodisher MediClean forte from the company Dr. Weigert. 1. Place the instrument against movement in the WD, so that the spray directly hits the instrument. Clean parts only in disassembled and unstressed condition. 2. Start the Vario TD-program incl. thermal disinfection. The thermal disinfection has to occur in consideration of the A0-value and national provisions (pren/iso 15883). Source and information to Miele: The process operates according to a fixed pattern: - Intensive pre-rinse with cold water 4 minutes - Cleaning with neodisher MediClean forte at a temperature of 55 C 10 minutes holding time. Please note the corresponding dosing instructions of the manufacturer, in this case Dr. Weigert. ( - Neutralization with warm water (> 40 C) 3 minutes - Intermediate rinse with warm water (> 40 C) 2 minutes - Thermal disinfection with deionized water (A0 value > 3000) - Drying 30 minutes. Remove the residual moisture from the instruments, especially in ports. To do this, use filtered compressed air, which does not lead to recontamination. If there is still visible contamination (blood, tissue adhesions) after mechanical reprocessing, the cleaning and disinfection must be done again. 4 / 6

5 13. Control and maintenance - Instruments need to be cooled to room temperature! - Assemble instruments for functional testing! - Cultivate joints, threads and friction surfaces after cleaning / disinfection, but before the functional test and sterilization with medicated oil spray or instrument milk. Use other maintenance products (paraffin / white oil-based and silicon-free) only if approved for steam sterilization and biocompatibility. - Sort out damaged instruments and check success of cleaning disinfection (repeat if necessary), return with decontamination certificate to us. 14. Packaging - No special requirements - Packaging according DIN EN 868/ ANSI AAMI ISO can be used 15. Sterilization Equipment: Steam sterilizer according DIN EN or DIN EN Sterilization is done after a thorough cleaning. It does not replace the cleanliness of instruments to be sterilized. - Put the instruments into an approved packaging for steam sterilization (soft packaging, sterile Containers with appropriate storage). - Sterilization occurs according a validated steam sterilization process in fractioned Vacuum process at 132 C. Other methods are not allowed for this sterilization. 1. Fractionated pre-vacuum (3 times) 2. Sterilization temperature 132 C plus tolerance according DIN EN ISO (or DIN EN 554)/ ANSI AAMI ISO Holding time in full cycle 5 minutes 4. Drying time: 10 minutes In order to avoid staining (silicate), or corrosion of the instrument, the steam must be free of ingredients. The recommended limits for particle contents in feed water and steam condensate is fixed by EN 285. Already infested instruments by corrosion must IMMEDIATELY be taken out of the Mineral processing cycle. When sterilizing multiple instruments, the maximum capacity of the sterilizer must not be exceeded (see information by respective manufacturers). Responsibility for cleaning, disinfection and sterilization of instruments rests solely with the Operators of sterilization department or product users. More detailed information on the reprocessing of medical devices can be found under the homepage of the Working Group Instrument reprocessing. Here you can download for free the latest version of the RED brochure. 16. Storage and treatment of instruments - Dry, dust-proof, no external force, no major temperature fluctuations and not in the immediate vicinity of aggressive media. - Useful in trays, containers, cabinets - Otherwise, no special or additional requirements 17. Confirmation notices The above instructions for the preparation of medical device for re-usage have been specified as suitable. The user (conditioner) is responsible for ensuring that the finally executed treatment with appropriate equipment, materials and personnel in the preparation facility reaches the desired results. For this, normally validation and routine monitoring of the process are required. Any deviation from the instructions provided by the user (conditioner) should carefully be evaluated on tis effectiveness and potential adverse consequences. 5 / 6

6 Part C: Application 18. General application The user has to become familiar with the product before using it. In no case an instrument may be used by carelessness so that a danger to patient, surgeon or surgical staff can be caused. This concerns mainly cutting, clamping or bruising instruments. You may need additional support tools to ensure a safe use of instruments. This may be necessary as an example for removing implant steel by using a bolt cutter. Here, a holding forceps serve to keep the severed piece safely. There is a risk of contamination of the patient in toothed working ends by chip formation while keeping implants such as bone plates, screws, wires and pins. By slipping through these toothed working ends under pressure (e.g. locking plier holds implant rod), chips can be either on the instrument or on the implant form, falling into the body cavity under certain circumstances. Manufacturer in the EC: Ortho Select GmbH, Eltastrasse 2, Wurmlingen Tel.: / Fax: / info@ortho-select.de / 6

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Manufacturer Silony Medical GmbH Leinfelder Strasse 60 70771 Leinfelden-Echterdingen Germany US Representative: Silony Medical Corp. 8200 NW 27TH STR, STE#104, DORAL, FL 33122 USA Phone: +1 305 916 0016