AESCULAP AE0061781 Ring Type Scissors and Spring Type Scissors
Specifications
- Product Type: Ring-type scissors and spring-type scissors
- Manufacturer: Aesculap AG
- Website: www.bbraun.com
- Phone: +49 (0) 7461 95-0
- Address: Am Aesculap-Platz, 78532 Tuttlingen, Germany
Product Usage Instructions
Clinical Application
The scissors are designed for various surgical purposes including cutting tissues, medical materials, nails, bandages, and clothing. Micro-scissors are specifically used in microsurgery procedures.
Intended Use
The scissors are suitable for a wide range of surgical procedures across all surgical fields. Please refer to the specific indications for use.
Safety Precautions
Before each use, inspect the product to ensure there are no loose or bent parts that could cause injury or malfunction.
Instructions for use/Technical description
Ring-type scissors and spring-type scissors
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.
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
- TA015820 2022-06
AESCULAP®
Ring-type scissors and spring-type scissors
About this document
Note
General risk factors associated with surgical procedures are not described in these instructions for use.
Scope
- These instructions for use apply to ring-type and spring-type scissors in nearly all surgical disciplines.
- Note
- The applicable CE mark for the product can be seen on the label or packaging of the product.
For article-specific instructions for use material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com
Safety messages
Safety messages make clear the dangers to patients, users,sr, and/or productsuct 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.
Clinical use
Areas of use and limitations of use
Intended use
Surgical scissors
The instruments are used to cut tissue and/or medical materials and supplies.
Dissecting scissors
The instruments are used to cut and/or dissect tissue.
Nail scissors
The instruments are used to cut or split fingernails toenailsails and/or cuticles.
Bandage scissors and material scissors
The instruments are used to cut medical materials anpplies and/or clothing.
Micro scissors
The instruments are used to cut and/or dissect tissue during microsurgical procedures.
Indications
The instruments are used in a multitude of surgical procedures and interventions in almost all surgicdisciplinesnes see Intended use.
Contraindications
No contraindications for the product are currently known.
Safety information
Clinical user
General safety information
To prevent damage caused by improper setup or operation, and to not compromise the mamanufacturer’sarranty 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, safe placelace forto usand e, 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 theoretical and practical proficiency in 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.
Sterility
The product is delivered in an unsterile condition.
- Clean the new product after removing its transport packaging and before its initial sterilization.
Application
WARNING
Risk of injury and/or malfunction!
- Before each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
- Always carry out a function test before each use of the product.
Validated reprocessing procedure
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.
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 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 corrosiandaand destroystainless 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 manufacturer’s 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”.
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 opportunity to recognize a product that is no longer functional, see Inspection.
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.
Cleaning/Disinfection
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,e and exposure time.
- Do not exceed a disinfection temperature of 96 °C.
- For products with plasma layers (e.g. Noir instruments), the layer can be damaged or worn if special cleaning procedures with oxidizing chemicals (e.g. hydrogen peroxide H2O2) are used.
- Do not use oxidizing chemicals for cleaning.
- For wet disposal, use suitable cleaning agents/disinfectants. To prevent foam formation and reduced efficiency of the process chemicals: Before mechanical cleaning and disinfection, rinse the product thor-oughly under running water
Validated cleaning and disinfection procedure
| Validated procedure | Specific requirements | Reference |
| Manual cleaning with immersion disinfection | ► Use a suitable cleaning brush.
► Keep working ends open when cleaning. ► Clean products with movable hinges in the open position or while moving the joints. ► Drying phase: Use a lint-free cloth or medical compressed air |
Chapter Manual cleaning/disinfection and sub-section:
■ Chapter Manual cleaning withh immersion disinfection |
| Mechanical alkaline cleaning and thermal disinfection | ► Place the product on a screen basket suitable for cleaning (make sure all areas will be reached by water jets).
► Keep working ends open when cleaning. ► Place the product on the sterilization tray with the hinge open. |
Chapter Mechanical cleaning/disinfection and sub-section:
■ Chapter Mechanical alkaline cleaning and thermal disinfection |
Manual cleaning/disinfection
- Before manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution.
- After manual cleaning/disinfection, check visible surfaces visually for residues.
- Repeat the cleaning/disinfection process if necessary.
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* |
| IV | Final rinse | RT
(cold) |
1 | – | FD-W | – |
| V | Drying | RT | – | – | – | – |
- D–W: Drinking water
- FD–W: 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 disinfection procedure.
Phase I
- Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible sur-faces 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 minute.
- 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 the 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.
Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
| 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:
– 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: Drinking water
- FD–W: 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
Inspection
- Allow the product to cool down to room temperature.
- Dry the product if it is wet.
Visual inspection
- Make sure all dirt has been removed. In particular, pay attention to, for example, mating surfaces, hinges, shafts, recessed areas, and drilled grooves.
- If the product is dirty: repeat the cleaning and disinfection process.
- Check the product for damage, e.g., corroded, loose, bent, broken, cracked, worn, heavily scratched, or missing parts.
- Check the product for missing or faded labels.
- Check the cutting edges for continuity, sharpness, nick,s, 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 TechnicaServicece.
Functional test
CAUTION
Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication!
- Before 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 properly (e.g. hinges, locks/latches, sliding parts, etc.).
- Make sure that the scissor blades provide light resistance when closing.
- Immediately put aside inoperative products and send them to Aesculap Technical Service, see TechnicalServicee.
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.
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 in fractionated vacuum process
- Steam sterilizer by DIN EN 285 and validated by DIN EN ISO 17665
- Sterilization in 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.
Storage
- Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.
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 due to sharp-edged and/or pointed products!
- When disposing of or recycling the product, ensure that the packaging prevents injury to the product.
Note
The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015820 2022-06 Change No. AE0061781
FAQs
Q: Where can I obtain the Instructions for Use if I am a United States user?
A: If you are a U.S. user, please visit the website at www.aesculapusaifus.com to obtain the specific Instructions for Use for United States users. You can also request a paper copy by contacting your local Aesculap representative or customer service at 1-800-282-9000.
Q: What are the different types of scissors included in the product?
A: The product includes ring-type scissors and spring-type scissors designed for various surgical tasks such as cutting tissues, nails, bandages, and materials.
Documents / Resources
 |
AESCULAP AE0061781 Ring Type Scissors and Spring Type Scissors [pdf] Instruction Manual AE0061781 Ring Type Scissors and Spring Type Scissors, AE0061781, Ring Type Scissors and Spring Type Scissors, Scissors and Spring Type Scissors, Spring Type Scissors, Scissors |