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Sterilizer baskets and accessories
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AESCULAP® en USA
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Instructions for use/Technical description Sterilizer baskets and accessories 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.aesculapusaifus.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 1-800-282-9000. A paper copy will be provided to you upon request at no additional cost. Gebrauchsanweisung/Technische Beschreibung Sterilisiersiebschalen und Zubehör Mode d’emploi/Description technique Tamis de stérilisation et accessoires Instrucciones de manejo/Descripción técnica Bandejas de esterilización por tamiz y accesorios Istruzioni per l’uso/Descrizione tecnica Cestelli per sterilizzazione e accessori Instruções de utilização/Descrição técnica Taças de rede de esterilização e acessórios Gebruiksaanwijzing/Technische beschrijving Sterilisatiezeefschalen en toebehoren Brugsanvisning/Teknisk beskrivelse Instrumentkurve og tilbehør Bruksanvisning/Teknisk beskrivning Steriliseringstrådkorgar och tillbehör Käyttöohje/Tekninen kuvaus Sterilointikorit ja lisätarvikkeet Lietošanas instrukcijas/tehniskais apraksts Sterilizācijas sieta trauki un piederumi Naudojimo instrukcija/techninis aprašas Tinklinės sterilizavimo kiuvetės ir priedai Инструкция по примению/Техническое описание Стерилизационные сетчатые корзины и принадлежности Návod k použití/Technický popis Sterilizační síta a příslušenství Instrukcja użytkowania/Opis techniczny Sita sterylizacyjne i akcesoria Návod na použitie/Technický opis Sterilizačné sieťové misky a príslušenstvo Használati útmutató/Műszaki leírás Sterilizáló szűrőtálcák és tartozékok Navodila za uporabo/Tehnični opis Mrežaste košare za sterilizacijo in dodatki Upute za uporabu/Tehnički opis Rešetkaste posude za sterilizaciju i pribor Manual de utilizare/Descriere tehnică Tăvile de filtrare sterilizante și accesoriile Упътване за употреба/Техническо описание Кошници за стерилизиране и принадлежности Kullanım Kılavuzu/Teknik açiklama Sterilizatör süzgeç tepsiler ve aksesuarlar Οδηγίες χρήσης/Τεχνική περιγραφή Διάτρητοι δίσκοι αποστείρωσης και πρόσθετα εξαρτήματα
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 TA015851
2021-01
Change No. 64152
en ®
AESCULAP Sterilizer baskets and accessories 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 all Aesculap sterilizer baskets and accessories ► 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.
WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.
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.
CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.
3.2
General information
Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.
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".
For indications, see Intended use.
3.3
2.
Clinical use
2.1
Areas of use and limitations of use
2.1.1
Intended use
Sterilizer baskets (incl. specific accessories): The Aesculap sterilizer baskets (incl. specific accessories: lid, inserts, separators, etc.) are used by OP and AEMP personnel and are dimensionally stable containers intended for repeated use. They used for holding goods to be cleaned and/or sterilized for preparation and for transport and storage in a sterile barrier system (e.g. sterilization containers, etc.). General accessories for sterilizer baskets: General accessories for sterilizer baskets (e.g. stop frame, retaining clips, locking pins, sterilizer clamps, sterilizer frames for knives, electrode holders, etc.) are used by OP and AEMP personnel and are intended for repeated use. They serve to hold goods to be sterilized in position as much as possible during the sterilization process, transport and storage.
2.1.2
2.1.3
Indications
Absolute contraindications
No known absolute contraindications.
2.1.4
Relative contraindications
Not known relative 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 The medical professional will make decisions on concrete applicability based on the warranted properties and technical data.
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
Limitations on reuse
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.
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
Risk of infection or damage to the medical devices due to insufficient or inappropriate reprocessing! The reprocessing procedure described below applies only to unloaded trays. ► For loaded trays, read and follow the instructions for reprocessing the products in their respective instructions for use. 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. ► 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.
3.5.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
► Suitable cleaning brush ► Drying phase: use a lint-free
Chapter Manual cleaning/disinfection and subsection:
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.
Mechanical alkaline cleaning and thermal disinfection
cloth or medical compressed air.
■ Chapter Manual cleaning with
► Place the product in the tray as
Chapter Mechanical cleaning/disinfection and subsection:
appropriate for cleaning (to avoid rinsing blind spots).
immersion disinfection
■ Chapter Mechanical alkaline cleaning and thermal disinfection
3.6
Manual cleaning/disinfection
3.8
► 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.
3.6.1
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*
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*
Inspection
► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.
3.8.1
Visual inspection
► Ensure that all contamination has been removed. In particular, pay attention to mating surfaces, hinges, shafts
and recessed areas. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► 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.
3.8.2
Functional test
IV
Final rinse
RT (cold)
1
-
FD-W
-
► Check that the product functions correctly. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
V
Drying
RT
-
-
-
-
3.9
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 ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
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.
Mechanical cleaning/disinfection
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.
3.7.1
Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
– 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.
3.10 Storage
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.
3.7
Steam sterilization
► Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent. ► Validated sterilization process
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: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11* 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.
► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
4.
Technical service
CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► 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. TA015851
2021-01
V6
Change No. 64152