accuratus swiss
Subtilis lever for the trochant bone 40° with two long peaks 30mm /33 cm No. 45
accuratus swiss Subtilis Range Instructions for Use
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INSTRUCTIONS FOR USE
Subtilis® Range of Surgical Instruments produced by Accuratus AG These instructions apply to reusable non-sterile surgical instruments, supplied by Accuratus AG, and intended for reprocessing in a health care facility setting. The instruments used to implant orthopaedic prostheses do not have an indefinite function life. All reusable instruments are subjected to repeated stresses related to bone contact, impaction and routing, cleaning and sterilization process. It is essential that the surgeon and operating theatre staff are fully conversant with the appropriate surgical technique for the instruments and associated implant, if any. CAUTION: These instructions DO NOT APPLY to single-use devices. These reprocessing instructions have been validated as being capable of preparing reusable instruments for reuse. It is the responsibility of the re-processor to ensure that the reprocessing is performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences. WARNINGS
• Do not exceed 140 °C during reprocessing steps. • Highly alkaline conditions can damage products with aluminium parts. • Complex devices, such as those with tubes, hinges, retractable features, mated surfaces, and textured surfaces, require special attention during cleaning. Manual pre-cleaning of such device features is required before automated cleaning processing. • Avoid exposure to hypochlorite solutions, as these will promote corrosion. • Ensure that no instruments or pieces of instruments are left in the surgical site prior to closure, as they may not be detectable using imaging techniques such as X-ray or MRI and patient injury may result.
Limitations on Reprocessing
• Repeated processing has minimal effects on instrument life and function. • End of useful life is generally determined by wear or damage in surgical use. • Damaged instruments should be repaired by the recognized manufacturer or replaced to prevent potential patient injury.
Decontamination Considerations - CJD
Under certain classifications of risk, the World Health Organization (WHO), or local regulatory authorities recommend special CJD (Creutzfeldt-Jakob Disease) inactivation processing procedures. Consult WHO and local regulations for further information.
Reprocessing Instructions Care at the Point of Use
• Remove debris, tissue or bone fragments. Remove excessive soil with a disposable wipe. • Immerse instruments in a neutral pH detergent solution or water to prevent drying and encrustation of surgical soil. • Avoid prolonged exposure to saline to minimize the chance of corrosion.
Containment & Transportation
• Reprocess instruments as soon as possible after use. • Universal precautions for handling bio-hazardous materials should be observed.
Preparation for Cleaning
• For instruments that require disassembly for cleaning, perform disassembly as shown in the applicable disassembly diagram for that instrument.
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A. Manual Cleaning: ALL INSTRUMENTS
• Clean delicate (microsurgical) instruments separately from other instruments. • Prepare an enzymatic neutral pH cleaning solution in accordance with the manufacturer’s instructions. • Soak soiled instruments per manufacturer’s instructions (minimum of 5 minutes) in the enzymatic solution. • Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hardto-reach areas, textured surfaces, or crevices. Rinse the instrument thoroughly with warm tap water. • Ultrasonically clean the instrument for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions. Rinse the instrument thoroughly with warm tap water. • Dry the instrument immediately after final rinse.
B. Manual Cleaning – Instruments with cannulas, lumens or holes
• Follow the steps in Section A. Manual Cleaning – ALL INSTRUMENTS. • When cleaning, use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the cannula, lumen, or hole. Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic neutral pH cleaning solution to flush hard to reach internal areas. • When rinsing, flush the cannulations, lumens, or holes with warm tap water. • Dry internal areas with filtered compressed air.
C. Manual Cleaning – Articulating Instruments (moveable parts)
• Follow the steps in Section A. Manual Cleaning – ALL INSTRUMENTS. • Immerse the instrument in the neutral pH cleaning solution to avoid aerosol generation. Actuate moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features. For instruments with flexible shafts, bend or flex the instrument under the neutral pH cleaning solution while brushing the flexible areas. • Actuate and/or retract moveable parts while rinsing. For instruments with flexible shafts, flex the instrument while rinsing. Dry internal areas with filtered compressed air.
Automated Cleaning
• For complex instruments, as described in Manual Cleaning sections B. and C. above, it is necessary to manually clean prior to automated processing to improve the removal of soil. • Clean, using the “INSTRUMENTS” cycle in a validated washer disinfector and a pH neutral cleaning agent intended for use in automated cleaning. The cleaning cycle should incorporate enzymatic pre-wash, wash, rinse, thermal rinse, and drying steps. • Load instruments so that hinges are open and cannulations, holes, and concave surfaces can drain. • Place heavier instruments on the bottom of containers. Do not place heavy instruments on top of delicate instruments.
Inspection and Functional Testing
• Inspect all instruments before sterilization or storage to ensure the complete removal of soil. • If areas are difficult to inspect visually, apply a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instruments thoroughly after using hydrogen peroxide solution. If soil is still present, re-clean the instrument. • Visually inspect the instrument and check for damage and wear. Cutting edges should be free of nicks and have a continuous edge, jaws and teeth should align properly, moveable parts should have smooth movement, locking mechanisms should fasten securely; long, thin instruments should be free of bending and distortion.
Disinfection
• Instruments must be terminally sterilized prior to surgical use. Re-assemble instrument (if applicable), prior to sterilization, in accordance with the disassembly/re-assembly instructions provided with the instrument. See Sterilization instructions.
Maintenance
• Lubricate moving parts with a water-soluble lubricant per the manufacturer’s instructions. • Lubrication should be performed after cleaning but before sterilization.
Packaging
• If desired, use instrument trays to contain instruments that are provided in sets. • Wrap instruments in accordance with local procedures, using standard wrapping techniques. • Label the contents of the wrapped tray using an indelible marker or other sterilization compatible label system.
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REVERSE REVERSE EN ARRIERE RÜCKWÄRTS DIRECCIÓN OPUESTA INVERSO INVERTER ACHTERUIT TILBAGE BAKÅT TAAKSEPÄIN ΠΡΟΣ TA ΠIΣΩ ZPĚTNÝ FORDÍTOTT ODWROTNY DOZADU
LOCK LOCK VERROUILLER SPERRE ENCLAVE BLOCCATO TRAVAR VERGRENDELEN LÅS LÅST LUKKO AΣΦAΛIΣMENΟ ZAMYKACÍ ZÁR BLOKADA ZAMKNUTÉ
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DO NOT DISASSEMBLE NE PAS DÉMONTER NICHT ZERLEGEN NO DESARMAR NON SMONTARE NÃO DESMONTAR NIET DEMONTEREN MÅ IKKE SKILLES AD FÅR EJ DEMONTERAS EI SAA PURKAA OSIIN NA MHN AΠΟΣYNAΡMΟΛΟΓEITA NEROZEBÍRAT NE SZERELJE SZÉT NIE ROZŁĄCZAĆ NEROZOBERAJTE
FORWARD FORWARD VERS L’AVANT VORWÄRTS HACIA ADELANTE AVANTI AVANÇAR VOORUIT FREM FRAMÅT ETEENPÄIN ΠPOΣ TA EMΠΡΟΣ PŘEDNÍ ELŐRE DO PRZODU DOPREDU
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APEX APEX APEX APEX APEX APICE APEX APEX APEX APEX KÄRKI ΚΟΡΥΦΗ APEX APEX APEX APEX
RESET TO GREEN RESET TO GREEN RÉINITIALISATION ZURÜCKSETZEN AUF GRÜN RESTABLECER A VERDE RESET AL VERDE REPOR EM VERDE OPNIEUW INSTELLEN OP GROEN NULSTIL TIL GRØN ÅTERSTÄLL TILL GRÖNT NOLLAA VIHREÄKSI ΕΠΑΝΑΦΕΡΕΤΕ ΣΤΗΝ ΠΡΑΣΙΝΗ ΓΡΑΜΜΗ VYNULOVAT NA ZELENOU ÁLLÍTSA VISSZA ZÖLDRE ZEROWANIE DO ZIELONEGO RESET NA ZELENÚ
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MUST USE WITH GUIDE SHAFT MUST USE WITH GUIDE SHAFT DOIT ÊTRE UTILISÉ AVEC UN AXE GUIDE VERWENDUNG NUR MIT FÜHRUNGSSCHAFT SE DEBE USAR CON VARILLA GUÍA UTILIZZARE CON LO STELO GUIDA DEVE SER UTILIZADO COM A HASTE GUIA MOET WORDEN GEBRUIKT MET GELEIDE-AS SKAL ANVENDES MED STYREFÆSTE MÅSTE ANVÄNDAS MED STYRSKAFT KÄYTETTÄVÄ OHJAUSVARREN KANSSA ΠΡΕΠΕΙ ΝΑ ΧΡΗΣΙΜΟΠΟΙΕΙΤΑΙ ΜΕ ΑΞΟΝΑ ΟΔΗΓΟ MUSÍ SE POUŽÍVAT S VODICÍM TUBUSEM VEZETŐ NYÉLLEL KELL HASZNÁLNI KONIECZNE UŻYCIE Z TRZPIENIEM NAPROWADZAJĄCYM MUSÍ SA POUŽÍVAŤ S VODIACIM HRIADEĽOM
NOT FOR USE WITH IMPLANT NOT FOR USE WITH IMPLANT NE PAS UTILISER AVEC UN IMPLANT NICHT FÜR DIE VERWENDUNG IN KOMBINATION MIT IMPLANTATEN NO SE DEBE USAR CON EL IMPLANTE DA NON UTILIZZARE CON L’IMPIANTO NÃO DESTINADO A UTILIZAÇÃO COM IMPLANTES NIET VOOR GEBRUIK MET IMPLANTAAT IKKE TIL BRUG MED IMPLANTAT EJ FÖR ANVÄNDNING MED IMPLANTAT EI KÄYTETTÄVÄKSI IMPLANTIN KANSSA ΝΑ ΜΗΝ ΧΡΗΣΙΜΟΠΟΙΕΙΤΑΙ ΜΑΖΙ ΜΕ ΕΜΦΥΤΕΥΜΑ NENÍ URČENO K POUŽITÍ S IMPLANTÁTEM NE HASZNÁLJA IMPLANTATUMMAL NIE DO UŻYTKU Z IMPLANTEM NIE JE URČENÉ NA POUŽITIE S IMPLANTÁTOM
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PRELIMINARY ASSEMBLY INSTRUMENT PRELIMINARY ASSEMBLY INSTRUMENT ASSEMBLAGE PRÉLIMINAIRE REQUIS VORBEREITENDE INSTRUMENTENMONTAGE INSTRUMENTO DE MONTAJE PRELIMINAR STRUMENTO PER L’ASSEMBLAGGIO PRELIMINARE INSTRUMENTO DE MONTAGEM PRELIMINAR VOORBEREIDENDE ASSEMBLAGE VAN HET INSTRUMENT INDLEDENDE SAMLING AF INSTRUMENTET PRELIMINÄRMONTERA INSTRUMENT INSTRUMENTIN ALUSTAVA KOKOAMINEN ΕΡΓΑΛΕΙΟ ΠΡΟΚΑΤΑΡΚΤΙΚΗΣ ΣΥΝΑΡΜΟΛΟΓΗΣΗΣ NÁSTROJ PRO PŘÍPRAVNÉ SESTAVENÍ ELŐZETES SZERELVÉNY MŰSZER INSTRUMENT DO WSTĘPNEGO MONTAŻU NÁSTROJ NA PREDBEŽNÉ ZOSTAVENIE
DISTRIBUTED BY DISTRIBUÉ PAR VERTRIEB DURCH DISTRIBUIDO POR DISTRIBUITO DA DISTRIBUÍDO POR GEDISTRIBUEERD DOOR DISTRIBUERET AF DISTRIBUERAS AV JAKELIJA ΔΙΑΝΕΜΕΤΑΙ ΑΠΟ ΤΗΝ DISTRIBUTOR FORGALOMBA HOZZA ROZPROWADZANE PRZEZ DISTRIBÚTOR
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