BBraun
Transsphenoidal specula
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AESCULAP® en USA
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Instructions for use/Technical description Transsphenoidal specula 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 Transsphenoidale Spekula Mode d’emploi/Description technique Spéculums transsphénoïdaux Instrucciones de manejo/Descripción técnica Espéculos transfenoidales Istruzioni per l’uso/Descrizione tecnica Specula transfenoidali Instruções de utilização/Descrição técnica Espéculos transesfenoidais Gebruiksaanwijzing/Technische beschrijving Transsfenoïdale specula Brugsanvisning/Teknisk beskrivelse Transsphenoidal spekula Bruksanvisning/Teknisk beskrivelse Transsfenoidalt spekulum Bruksanvisning/Teknisk beskrivning Transsfenoidalt spekulum Käyttöohje/Tekninen kuvaus Transfenoidaalinen tähystin Kasutusjuhend/Tehniline kirjeldus Transsfenoidaalne speekul Lietošanas instrukcijas/tehniskais apraksts Deguna paplašinātāji Naudojimo instrukcija/techninis aprašas Transfenoidinis plėtiklis Инструкция по примению/Техническое описание Зеркало для транссфеноидальной хирургии Návod k použití/Technický popis Transsfenoidální zrcátka Instrukcja użytkowania/Opis techniczny Wzierniki transfenoidalne Návod na použitie/Technický opis Transfenoidálne spekulum Használati útmutató/Műszaki leírás Transzszfenoidális spekulum Navodila za uporabo/Tehnični opis Transsfenoidni spekulum Upute za uporabu/Tehnički opis Transsfenoidalni spekulumi Manual de utilizare/Descriere tehnică Specule transsfenoidale Упътване за употреба/Техническо описание Трансфеноидални спекулуми Kullanım Kılavuzu/Teknik açiklama Transsfenoidal spekula Οδηγίες χρήσης/Τεχνική περιγραφή Διασφηνοειδής διαστολέας
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 TA016757
2023-03
Change No. AE0062739
en AESCULAP® Transsphenoidal specula 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 transsphenoidal specula. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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: 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.
3.2
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 precleaning 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".
3.3
Reusable products
Clinical use
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.
2.1
Areas of use and limitations of use
3.4
2.1.1
Intended use
► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for
2.
Transsphenoidal specula are used in transsphenoidal hypophysectomy. The specula are inserted into the nostril to create and enlarge the operating tunnel.
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. 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
Preparations at the place of use
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
Danger to the patient! The product must not be manually processed. ► Process the product only in a mechanical washer/disinfector. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.
3.5.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
Reference
Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
■ Place the product on a tray that is
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
3.
Validated reprocessing procedure
3.1
General safety instructions
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.
■ Place the product on the tray with all product links and joints open.
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
3.6
Mechanical cleaning/disinfection with manual pre-cleaning
Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.6.1
Manual pre-cleaning with a brush
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
Rinsing
RT (cold)
1
-
D–W
-
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.
suitable for cleaning (avoid rinsing blind spots).
D-W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and
disinfection 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.
3.6.2
Mechanical alkaline cleaning and thermal disinfecting
Phase
Step
T [°C/°F]
I
Prerinse
<25/77
II
Cleaning
55/131
t [min]
Water quality
Chemical
3
D–W
-
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-germ, max. 10 KBE/100ml, as well as low endotoxin contaminated, max. 0.25 endotoxin units/ml) *Recommended: B. Braun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.7
Inspection
► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.
3.7.1
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. 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.
3.7.2
Functional test
CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► 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.
3.8
Packaging
► Place the product in its holder or on a suitable tray. ► For packaging the trays, use sterile barrier packaging system according to ISO 11607-1 (e.g., Aesculap ster-
ile container system). ► Ensure that the packaging provides sufficient protection against contamination of the product during stor-
age.
3.9
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.
3.10 Storage ► 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. ► 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. TA016757
2023-03
Change No. AE0062739