BBraun
Orthopedic and trauma instruments
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Aesculap®
Aesculap Orthopaedics
en USA
de fr es it pt nl da sv fi lv lt ru cs pl sk hu sl hr ro bg tr el
Instructions for use/Technical description Orthopedic and trauma instruments Note for U.S. users This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use for United States users can be obtained by visiting our website at www.aesculapImplantsystems.com. If you wish to obtain a paper copy of the Instructions for Use, you may request one by contacting your local Aesculap representative or Aesculap's customer service at 1-866-229-3002. A paper copy will be provided to you upon request at no additional cost. Gebrauchsanweisung/Technische Beschreibung Orthopädie- oder Traumatologieinstrumentarium Mode d’emploi/Description technique Instruments d’orthopédie ou de traumatologie Instrucciones de manejo/Descripción técnica Instrumental de ortopedia o traumatología Istruzioni per l’uso/Descrizione tecnica Strumentario per ortopedia e traumatologia Instruções de utilização/Descrição técnica Conjunto de instrumentos de ortopedia e traumatologia Gebruiksaanwijzing/Technische beschrijving Orthopedie- of traumatologie-instrumentarium Brugsanvisning/Teknisk beskrivelse Ortopædi- eller traumatologi-instrumenter Bruksanvisning/Teknisk beskrivning Ortopedi- eller traumatologiinstrument Käyttöohje/Tekninen kuvaus Ortopedia- tai traumatologiainstrumentit Lietošanas instrukcijas/tehniskais apraksts Ortopēdijas vai traumatoloģijas instrumenti Naudojimo instrukcija/techninis aprašas Ortopediniai arba traumatologiniai instrumentai Инструкция по примению/Техническое описание Ортопедический и травматологический инструментарий Návod k použití/Technický popis Ortopedické a traumatologické instrumentárium Instrukcja użytkowania/Opis techniczny Instrumentarium dla ortopedii i traumatologii Návod na použitie/Technický opis Ortopedické alebo traumatologické inštrumentárium Használati útmutató/Műszaki leírás Ortopédiai vagy traumatológiai műszerkészlet Navodila za uporabo/Tehnični opis Ortopedski ali travmatološki instrumenti Upute za uporabu/Tehnički opis Instrumenti za ortopediju ili traumatologiju Manual de utilizare/Descriere tehnică Instrumentar pentru ortopedie sau traumatologie Упътване за употреба/Техническо описание Ортопедични или травматологични инструменти Kullanım Kılavuzu/Teknik açiklama Ortopedi ya da travmatoloji ekipmanları Οδηγίες χρήσης/Τεχνική περιγραφή Όργανα ορθοπεδικής ή τραυματολογίας
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap® – a B. Braun brand TA013850
0482
2020-09
V6
Change No. 63450
en
3.2 ®
Aesculap Orthopedic and trauma instruments 1.
About this document
Note General risk factors associated with surgical procedures are not described in these instructions for use.
1.1
Scope
These instructions for use apply to instruments with lumens or indentations, as well as collapsible instruments that are composed entirely or in part of sensitive materials (e.g. aluminium or POM). Note The valid CE mark for the product can be found on the label of the packaging of the product. ► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com
1.2
Safety messages
Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows:
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".
WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.
3.3
CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.
Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.
2.
Clinical use
2.1
Areas of use and limitations of use
2.1.1
Intended use
The orthopedic or trauma instrument is used in orthopedic or trauma surgery, e.g. for procedures involving implantations of endoprostheses or fracture implants.
2.1.2
Indications
Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. The indications correspond to those of the implant system used.
2.1.3
Absolute contraindications
The absolute contraindications correspond to those of the implant system used.
2.1.4
Relative contraindications
The relative contraindications correspond to those of the implant system used. In the presence of relative contraindications, the user decides individually regarding the use of the product.
2.2
Safety information
2.2.1
Clinical user
General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located.
3.4
Reusable products
Preparations at the place of use
► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
3.5
Preparing for cleaning
► Do not disassemble fixation screws which permanently connect the various components. ► Disassemble separable instrument (e.g. with set screws) prior to cleaning.
3.6
Cleaning/Disinfection
3.6.1
Product-specific safety information on the reprocessing method
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► With PVD coated products, do not use oxidizing process chemicals (e.g. H2O2), as these can cause bleaching or
layer loss. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foaming and
degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water
3.6.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free
Chapter Manual cleaning/disinfection and subsection:
Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■ Connect components with
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting
lumens and channels directly to the rinsing port of the injector carriage.
■ Keep working ends open for cleaning.
Sterility
■ Place the product on the tray
The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.
2.3
immersion disinfection
cloth or medical compressed air
Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.
2.2.2
■ Chapter Manual cleaning with
with all product links and joints open.
Application
WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.
3.
Validated reprocessing procedure
3.1
General safety information
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
3.7
Manual cleaning/disinfection
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.
3.7.1
Manual cleaning with immersion disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfecting cleaning
RT (cold)
>15
2
D–W
Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
III
Disinfection
RT (cold)
5
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
Note If there is no final sterilization, then a virucidal disinfectant must be used.
V
Drying
RT
-
-
-
-
Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
D–W: FD–W:
Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this.
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
3.8
Mechanical cleaning/disinfection with manual pre-cleaning
Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.8.1
Manual pre-cleaning with a brush
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfectant cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
Rinsing
RT (cold)
1
II
D–W
-
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase
Step
Inspection
► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.
3.9.1
Visual inspection
► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed
areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service.
3.9.2
Functional test
► This product should be assembled prior to sterilization. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check rotating products (e.g. reusable drills and cutters) for bends and deformities. To do this, roll the product
on an even surface. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.10 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.11 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by
opening any valves and faucets). ► Validated sterilization process
– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.
3.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
-
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh
3.8.2
3.9
T [°C/°F]
t [min]
Water quality
Chemical
4.
Technical service
CAUTION Modifications to medical technology equipment result in loss of approval and can result in forfeiture of guarantee/warranty claims. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.
5.
Disposal
WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA013850
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral:
■ Concentrate: – pH neutral – <5 % anionic surfactant
■ 0.5 %* working solution Mildly alkaline:
■ Concentrate: – pH = 9.5 – <5 % anionic surfactant
■ 0.5 % solution III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.
2020-09
V6
Change No. 63450