AESCULAP Ring-Type and Spring-Type Scissors

1. About This Document

General risks of surgical intervention are not described in these instructions for use.

1.1 Scope of Application

These instructions for use are valid for ring-type and spring-type scissors in practically all surgical specialties.

The CE mark valid for the product can be found on the product label and packaging.

For item-specific instructions for use, as well as information on material compatibility and product service life, please refer to B. Braun eIFU at eifu.bbraun.com.

1.2 Warnings

Warnings alert to dangers for the patient, user, and product that may arise during product use. Warnings are marked as follows:

[WARNING] Indicates a possible risk. If not avoided, minor to moderate injuries may occur.

[CAUTION] Indicates possible material damage. If not avoided, the product could be damaged.

2. Clinical Use

2.1 Scope of Application and Limitation of Use

2.1.1 Intended Use

• Surgical Scissors: The instrument is used for cutting tissues and/or medical excipients.
• Dissecting Scissors: The instrument is used for cutting and/or dissecting tissues.
• Nail Scissors: The instrument is used for cutting or splitting fingernails and toenails and/or the cuticle.
• Dressing and Material Scissors: The instrument is used for cutting medical utensils and/or clothing.
• Micro Scissors: The instrument is used for cutting and/or dissecting tissues in microsurgical procedures.

2.1.2 Indications

The instrument is used in a wide range of interventions and procedures in practically all surgical specialties, see Intended Use.

2.1.3 Contraindications

No contraindications for the product are currently known.

2.2 Safety Warnings

2.2.1 Clinical Users

General Safety Warnings

To prevent damage caused by improper handling and use, and thus preserve the manufacturer's warranty and liability rights:

• Use the product only in accordance with these instructions for use.
• Observe the information on safety measures and maintenance instructions.
• The application and use of the product and accessories must be entrusted exclusively to personnel with the required training or who possess the necessary knowledge and experience.
• Store the product new from the factory or not yet used in a dry, clean, and protected place.
• Before using the product, check that it functions and is in perfect condition.
• Keep the instructions in an accessible place for the operator.

Note

The user is obliged to notify the manufacturer and the competent authorities in the country of any serious incidents related to the product in which they are involved.

Observations on Surgical Interventions

The user will be responsible for performing the surgical intervention appropriately.

Successful use of this product requires corresponding clinical training, as well as theoretical and practical mastery of all necessary surgical techniques, including the handling of this product.

The user is obliged to request information from the manufacturer if the pre-operative situation regarding the use of the product is unclear.

2.2.2 Sterility

The product is supplied non-sterile.

• Thoroughly clean the new product from the factory after unpacking and before the first sterilization.

2.3 Application

[WARNING] Risk of injury and/or malfunctions.

• Before each use, visually inspect the product for loose, bent, broken, cracked, or worn parts.
• Check functionality before each use.

3. Approved Process for Surgical Instrument Processing

3.1 General Safety Warnings

Note

Comply with legal provisions and national and international standards and guidelines, in addition to the hygiene regulations of the facility where product processing will take place.

Note

In the case of patients suffering from Creutzfeldt-Jakob disease, or suspected of suffering from this disease or its variants, the current country-specific regulations regarding product processing must be complied with.

Note

Automatic processing should be preferred over manual cleaning, as it yields a safer and more effective result.

Note

It should be noted that the correct cleaning of this medical device can only be guaranteed through prior validation of the processing procedure. In this case, responsibility lies with the user/person responsible for said procedure.

Note

A virucidal cleaning agent should be used if the product is not to be sterilized subsequently.

Note

For up-to-date information on product preparation and material compatibility, also visit B. Braun eIFU at eifu.bbraun.com.

The approved steam sterilization method has been performed in the Aesculap sterile container system.

3.2 General Information

Dried or encrusted residues from surgical interventions can make cleaning difficult or ineffective, causing corrosion damage. For this reason, no more than 6 hours should pass between use and cleaning, pre-wash temperatures should not exceed >45 °C, and disinfectants with fixatives (with aldehyde and alcohol bases) that can promote encrustation should not be used.

Excessive doses of neutralizing agents or solvents can cause chemical attack and/or discoloration, as well as visual or automatic illegibility of laser inscriptions on stainless steel.

For stainless steel products, chlorine residues and chlorinated substances (e.g., those contained in surgical intervention residues, medications, saline solutions, cleaning, disinfection, and sterilization water) can cause irreversible corrosion damage (pitting corrosion, internal corrosion) to these products and eventually destroy them. To remove any residue, products must be thoroughly rinsed with completely demineralized water, then dried. Perform a final drying if necessary.

Only use proven and authorized process chemicals (e.g., authorized by VAH/DGHM or FDA, or with CE marking) recommended by the manufacturer regarding material compatibility. All manufacturer instructions for the chemical must be strictly followed. Otherwise, the following problems may arise:

• Optical material alterations, such as discoloration or color change in the case of titanium or aluminum. Visible alterations may appear on aluminum surfaces from pH values above 8 in the working solution.
• Material damage such as corrosion, cracks, breakage, premature aging, or swelling.

• Never clean the surface with metal brushes or other abrasive agents, as there is a risk of corrosion.
• For more information on hygienic, safe, and material-friendly sterilization and cleaning, see www.a-k-i.org section "AKI-Brochures", "Red brochure".

3.3 Reusable Products

Factors that can cause product damage from its processing are unknown.

To detect product malfunction, it is advisable to perform a visual and functional examination before first use, see Inspection.

3.4 Preparation at the Point of Use

• Where applicable, non-visible surfaces should be irrigated with running, completely demineralized water, e.g., with a disposable syringe.
• Completely remove visible residues from surgical interventions with a damp, lint-free cloth.
• Place the dried products in the waste container, close it, and proceed with cleaning and disinfection within a maximum of 6 hours after use.

3.5 Cleaning/Disinfection

3.5.1 Specific Safety Warnings for Processing

Product damage or destruction may occur due to the use of unsuitable cleaning/disinfection agents and/or excessively high temperatures.

• Use detergents/disinfectants according to the manufacturer's instructions.
• Observe concentration, temperature, and exposure time values.
• Do not exceed the disinfection temperature of 96 °C.

For products with plasma coatings (e.g., Noir instruments), special cleaning procedures involve adding oxidizing chemicals (e.g., hydrogen peroxide H2O2) that attack or remove the coatings.

• Do not use oxidizing chemicals for cleaning.
• Use detergents/disinfectants suitable for removing wet debris. To prevent foaming and reduce the effectiveness of process chemicals: Before automatically cleaning and disinfecting the product, it should be rinsed with plenty of running water.

3.5.2 Approved Cleaning and Disinfection Process

AP: Potable water

ACD: Completely demineralized water with at least potable water quality from a microbiological perspective

TA: Ambient temperature

*Recommended: BBraun Stabimed fresh

• Follow the recommendations for suitable disposable syringes and cleaning brushes, see Approved Cleaning and Disinfection Process.

Phase I

• Immerse the entire product in the cleaning-disinfectant solution for at least 15 min. Ensure all accessible surfaces are wetted.
• Clean the product with a suitable cleaning brush until all surface residues are removed.
• Where applicable, non-visible surfaces should be brushed with a suitable brush for at least 1 min.
• During cleaning, move movable components, such as adjustment screws, joints, etc.
• Subsequently, rinse these areas thoroughly with the cleaning-disinfectant solution at least 5 times using a disposable syringe.

Phase II

• Thoroughly rinse the product with running water (all accessible surfaces).
• While rinsing, move movable components, such as adjustment screws, joints, etc.
• Allow excess water to drain sufficiently.

Phase III

• Immerse the entire product in the disinfectant solution.
• While disinfecting, move movable components, such as adjustment screws, joints, etc.
• Irrigate lumens at the beginning of the exposure time, at least 5 times, with a suitable disposable syringe. Ensure all accessible surfaces are wetted.

Phase IV

• Thoroughly rinse the product (all accessible surfaces).
• During the final rinse, move movable components, such as adjustment screws, joints, etc.
• Irrigate lumens at least 5 times with a suitable disposable syringe.
• Allow excess water to drain sufficiently.

Phase V

• Dry the product during the Drying Phase with wipes or medical compressed air, see Approved Cleaning and Disinfection Process.

3.7 Automatic Cleaning/Disinfection

Note

The effectiveness of the cleaning and disinfection device must be certified (e.g., FDA approved and CE marked according to DIN EN ISO 15883).

Note

Regular inspection and maintenance of the cleaning and disinfection device shall be carried out.

3.7.1 Automatic Alkaline Cleaning and Thermal Disinfection

Device Type: Single-chamber cleaning/disinfection device without ultrasound

AP: Potable water

ACD: Completely demineralized water with at least potable water quality from a microbiological perspective

*Recommendation: BBraun Helimatic Cleaner alkaline

• After automatic cleaning/disinfection, check that no residues remain on visible surfaces.

3.8 Inspection

• Allow the product to cool to ambient temperature.
• Dry the product if it is damp or wet.

3.8.1 Visual Inspection

• Ensure all dirt has been removed. Special attention should be paid to, for example, adjustment surfaces, hinges, shanks, deep points, and boreholes.
• For dirty products: repeat the cleaning and disinfection process.
• Check that the product shows no damage, e.g., corroded, loose, bent, broken, cracked, worn, heavily scratched, or broken parts.
• Check if product labels are discolored or missing.
• Check if cutting edges are continuous, sharp, or have nicks or other damage.
• Check if surfaces show rough changes.
• Check if the product has burrs that could damage tissues or surgical gloves.
• Check if the product has damaged or missing parts.
• Immediately remove the product if it is damaged and send it to Aesculap Technical Service, see Technical Service.

3.8.2 Function Test

[CAUTION] Risk of product damage (metal degradation/fretting corrosion) if not sufficiently lubricated.

• Lubricate moving parts (e.g., joints, sliding parts, and threaded rods) before performing the function test with a conservation oil suitable for the sterilization method applied (e.g., for steam sterilization STERILIT® spray oil | JG600 or STERILIT® drip lubricator | JG598).
• Check the product's functionality.
• Ensure all moving parts (e.g., hinges, locks/latches, sliding parts, etc.) move correctly.
• Ensure the scissor blades move against each other with slight resistance.
• Immediately remove the product if it does not function and send it to Aesculap Technical Service, see Technical Service.

3.9 Packaging

• Protect products with fine working ends well.
• Place the product in the corresponding holder or basket. Ensure existing cutting edges are protected.
• Package the baskets according to the sterilization procedure (e.g., in Aesculap sterile containers).
• Ensure the packaging is reliable and will prevent recontamination of the product during storage.

3.10 Steam Sterilization

• Ensure the sterilizing medium has access to all external and internal surfaces (by opening valves and taps, for example).
• Validated sterilization method: Autoclave sterilization using the fractionated vacuum method. Autoclave according to DIN EN 285 and validated according to DIN EN ISO 17665. Sterilization using the fractionated vacuum method at 134 °C for 5 min.
• When carrying out simultaneous sterilization of several products in a steam sterilizer, ensure that the sterilizer is not loaded beyond the manufacturer's specifications.

3.11 Storage

• Store sterile products in packaging with a bacterial barrier in a dry, dark place, protected from dust and at a constant temperature.

4. Technical Service

[CAUTION] If modifications are made to the technical medical equipment, the warranty and guarantee rights, as well as any approvals, will be voided.

• Do not modify the product.
• For technical assistance and repairs, contact your B. Braun/Aesculap distributor.

Technical 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

Information on other Technical Service addresses will be provided at the address specified above.

5. Disposal of Waste

[WARNING] Risk of infection from contaminated products.

• It is mandatory to comply with national regulations when disposing of or recycling the product, its components, and packaging.

[WARNING] Risk of injury from products with sharp and pointed edges.

• When disposing of or recycling the product, it must be ensured that the packaging prevents injuries from the product.

Note

The operating company must clean the product before disposal, see Approved Process for Surgical Instrument Processing.

Product Number: TA015820

Date: 2022-06

Change No.: AE0061781