BBraun
Single-piece instruments made from high-grade steel, titanium alloysand plastics suitable for alkaline processing
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Instructions for use/Technical description Single-piece instruments made from high-grade steel, titanium alloys and plastics suitable for alkaline processing 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.aesculapimplantsystemsifus.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 Einteilige Instrumente aus Edelstahl, Titanlegierungen und alkalisch aufbereitbaren Kunststoffen Mode d’emploi/Description technique Instruments monobloc en acier inoxydable, en alliages au titane et en plastique alcalin retraitable Instrucciones de manejo/Descripción técnica Instrumental de una sola pieza de acero inoxidable, aleaciones de titanio y plásticos aptos para la limpieza alcalina Istruzioni per l’uso/Descrizione tecnica Strumenti monopezzo in acciaio inossidabile, leghe di titanio e plastiche trattabili con sostanze alcaline Instruções de utilização/Descrição técnica Instruções de utilização de instrumentos monobloco em aço inoxidável, ligas de titânio e plásticos tratados por alcalinos Gebruiksaanwijzing/Technische beschrijving Eendelige instrumenten van roestvrij staal, titaniumlegeringen en alkalisch behandelbare kunststoffen Brugsanvisning/Teknisk beskrivelse Instrumenter i ét stykke af rustfrit stål, titaniumlegeringer og alkalisk behandlet plast Bruksanvisning/Teknisk beskrivning Instrument i ett stycke av rostfritt stål, titanlegeringar och plast som kan bearbetas alkaliskt Käyttöohje/Tekninen kuvaus Yksiosaiset instrumentit, jotka on valmistettu ruostumattomasta teräksestä, titaaniseoksista ja emäksisesti käsiteltävistä muoveista Lietošanas instrukcijas/tehniskais apraksts Viengabala instrumenti, kas izgatavoti no nerūsējošā tērauda, titāna sakausējumiem, alvas vai pārstrādātas sārmainas plastmasas Naudojimo instrukcija/techninis aprašas Vientisi instrumentai iš nerūdijančio plieno, titano lydinių arba šarminiu būdu perdirbamo plastiko Инструкция по примению/Техническое описание Цельные инструменты из нержавеющей стали, титановых сплавов и стойких к щелочному воздействию пластмасс Návod k použití/Technický popis Jednodílné nástroje z ušlechtilé oceli, titanových slitin a plastů s možností alkalické předsterilizační přípravy Instrukcja użytkowania/Opis techniczny Instrumenty jednoczęściowe ze stali nierdzewnej, stopów tytanu i tworzyw sztucznych przygotowywane do użycia przy zastosowaniu środków o odczynie zasadowym Návod na použitie/Technický opis Jednodielne nástroje vyrobené z nehrdzavejúcej ocele, zliatin titánu a plastov, ktoré je možné spracovávať alkalickým spôsobom Használati útmutató/Műszaki leírás Egydarabos műszerek rozsdamentes acélból, titánötvözetekből és lúgos tisztítószerekkel regenerálható műanyagokból Navodila za uporabo/Tehnični opis Enodelni instrumenti iz legiranega jekla, titanovih zlitin in umetnih materialov, ki dopuščajo obdelavo v alkalnem okolju Upute za uporabu/Tehnički opis Jednodijelni instrumenti od oplemenjenog čelika, slitina titanija ili plastike koja se može tretirati alkalnim sredstvima Manual de utilizare/Descriere tehnică Instrumente dintr-o singură piesă, din oțel inoxidabil, aliaje de titan și mase plastice reprocesabile în mediu alcalin Упътване за употреба/Техническо описание Еднокомпонентни инструменти от неръждаема стомана, титаниеви сплави и алкално обработваеми пластмаси Kullanım Kılavuzu/Teknik açiklama Paslanmaz çelikten, titanyum alaşımdan ve alkali olarak işlenebilen plastikten üretilmiş tek parçalı aletler Οδηγίες χρήσης/Τεχνική περιγραφή Εργαλεία ενός τεμαχίου από ανοξείδωτο χάλυβα, κράματα τιτανίου και πλαστικά με δυνατότητα επεξεργασίας με αλκαλικά προϊόντα
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.bbraun.com AESCULAP® – a B. Braun brand TA015365
2021-04
Change No. AE0060818
en ®
AESCULAP Single-piece instruments made from high-grade steel, titanium alloys and plastics suitable for alkaline processing 1.
About this document
Note General risk factors associated with surgical procedures are not described in these instructions for use.
1.1
Scope
Single-piece instruments, of which all surfaces are directly accessible and visible. The instruments do not contain aluminum, nickel-silver or tin components and are not nickel-plated or chrome-plated. Note The applicable CE mark for the product can be found on the label or packaging of the product. ► For article specific instructions for use and material compatibility and lifetime information, 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:
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. 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. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 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. Note If there is no final sterilization, then a virucidal disinfectant must be used. 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.
3.2
General information
The spinal instrument set is used for applications as part of procedures such as implantation of implants for the stabilization of the spine or for the fusion of vertebral bodies.
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:
2.1.2
■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.
2.
Clinical use
2.1
Areas of use and limitations of use
2.1.1
Intended use
Indications
Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.
2.1.3
Contraindications
No known contraindications.
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. 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
Sterility
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
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. ► Always ensure a complete attachment with the designated instrument or implant prior to each use of the product. WARNING Risk of injury due to instrument penetration which is too deep or wrong choice of instrument!? The markings and scales on the instrument should only be taken as guidance! ► Always perform visual inspection while using invasive instruments.
tion/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".
3.3
Reusable products
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 option to determine if a product is no longer functional, see Inspection.
3.4
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
Cleaning/Disinfection
3.5.1
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 approved for plastics and high-grade steel 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. ► If there are residues of bone, tissue or medical materials and supplies (e.g. casting compound, bone cement): pre-
clean the product manually (using a cleaning brush).
3.5.2
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:
■ all except FW176R
cloth or medical compressed air Manual cleaning using ultrasound and immersion disinfection
■ FW176R
■ Suitable cleaning brush ■ Disposable syringe 20ml ■ Drying phase: Use lint free cloth or medical compressed air
Alkaline machine cleaning and thermal disinfection
■ all except FW176R
Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
■ FW176R
■ Place product on a sterile screen basket suitable for cleaning (make sure all areas will be reached by water jets).
■ Suitable cleaning brush ■ Disposable syringe 20ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■ Chapter Manual cleaning with immersion disinfection Chapter Manual cleaning/disinfection and sub-sections:
■ Chapter Manual cleaning with ultrasound and immersion disinfection Chapter Machine cleaning/disinfection and sub-sections:
■ Chapter Mechanical alkaline cleaning and thermal disinfection Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
3.6
Manual cleaning/disinfection
Phase IV
► 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.
► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.
3.6.1
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
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
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).
II
Intermediate rinse
RT (cold)
1
-
D–W
-
Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
III
Disinfection
RT (cold)
5
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
3.7.1 Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical/Note
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
3.7
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh
Machine cleaning/disinfection
Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
– pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11*
► 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.
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 alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.8
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*
II
Rinsing
RT (cold)
1
-
D–W
-
Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
3.6.2
Manual cleaning with ultrasound and immersion disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
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
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh
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).
D–W: Drinking water 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.
3.8.2
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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.
– pH ~ 13 – <5 % anionic surfactant
■ working solution 0.5% – pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
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.
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
In accordance with the program for the cleaning and disinfecting machine
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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.9
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 products having long, narrow geometries (in particular rotating instruments) for deformations. ► 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
► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.10 Packaging ► Appropriately protect products with fine working tips. ► 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.
4.
Technical service
CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015365
2021-04
Change No. AE0060818