Aesculap Spring-Handle Surgical Instruments

Introduction

This document provides instructions for the use and reprocessing of Aesculap spring-handle surgical instruments.

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 the website at www.aesculapusa.com. A paper copy can be requested from your local Aesculap representative or Aesculap's customer service at 1-800-282-9000.

The general risks of surgical procedures are not described in these instructions.

Scope of Application

Scope: Spring-handle instruments, with and without locking mechanism.

Intended Use: The instruments are used in universal surgical applications across all specialties.

Indications: Refer to Intended Use.

Contraindications:

• Absolute Contraindications: None known.
• Relative Contraindications: Medical or surgical conditions (e.g., comorbidity) that could hinder the success of the operation may cause healing delays or endanger the success of the operation. In case of relative contraindications, the user must decide individually whether to use the product.

Safety Warnings

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

⚠️ WARNING: Indicates a potential risk. If not avoided, minor to moderate injuries may occur.

❗ ATTENTION: Indicates potential material damage. If not avoided, the product may be damaged.

General Safety Warnings for Clinical Users

To prevent damage from improper treatment and use, and to 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 with the necessary knowledge and experience.
• ▶️ Store new or unused products 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 of the country of any serious incidents related to the product in which they are involved.

Observations on Surgical Procedures

The user is responsible for performing the surgical procedure adequately. Successful use of this product requires corresponding clinical training and mastery of all necessary surgical techniques, both theoretical and practical, 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.

Sterility

The product is supplied non-sterile.

• ▶️ Clean the new product thoroughly after unpacking and before the first sterilization.

Application

⚠️ WARNING: Risk of injury and/or malfunction.

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

Approved Process for the Treatment of Surgical Instruments

General Safety Warnings

• ▶️ Comply with legal provisions and national and international standards and guidelines, as well as the hygiene regulations of the facility where product treatment will take place.
• ▶️ In the case of patients suffering from Creutzfeldt-Jakob disease, or suspected of suffering from it or its variants, the current country-specific regulations regarding product treatment must be complied with.
• ▶️ Automatic processing is preferred over manual cleaning, as it yields a safer and more effective result.
• ▶️ It must be taken into account that the correct cleaning of this medical device can only be guaranteed through prior validation of the treatment process. In this case, the responsibility lies with the user/responsible person for said process.
• ▶️ A virucidal cleaning agent must be used if the product is not to be sterilized immediately afterwards.
• ▶️ For up-to-date information on product preparation and material compatibility, also visit B. Braun eIFU at eifu.bbraun.com.
• ▶️ The validated steam sterilization method was performed using the Aesculap sterile container system.

General Indications

Dried or encrusted residues from surgical procedures can hinder or make cleaning ineffective, leading to corrosion damage. Therefore, no more than 6 hours should pass between use and cleaning, pre-wash temperatures should not exceed >45 °C, and disinfectants with fixatives (based on aldehyde and alcohol) that can promote encrustation should not be used.

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

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

Only use process chemicals that have been tested and approved (e.g., approved by VAH/DGHM or FDA, or CE marked) and are recommended by the manufacturer regarding material compatibility. All manufacturer instructions for the chemical product 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, breaks, 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".

Reusable Products

Factors that can cause product damage from its processing are unknown. To detect if the product is not functioning, it is advisable to perform a visual and functional examination before the first use (see Inspection).

Preparation at the Place of Use

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

Cleaning/Disinfection

Specific Safety Warnings for Treatment Process

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

• ▶️ Use only disinfectants/cleaning agents in accordance with the manufacturer's instructions that are suitable for use on stainless steel.
• ▶️ Observe the concentration, temperature, and exposure time values.
• ▶️ Do not exceed the disinfection temperature of 95 °C.
• ▶️ If microsurgical products can be securely and suitably fixed for cleaning in machines or on holders, they can be cleaned and disinfected automatically.

Approved Cleaning and Disinfection Process

Manual Cleaning/Disinfection

• ▶️ Before manual disinfection, allow irrigation water residues to drain first to prevent dilution of the disinfectant.
• ▶️ After manual cleaning/disinfection, visually check that no residues remain on visible surfaces.
• ▶️ If necessary, repeat the cleaning/disinfection process.

Manual Cleaning with Immersion Disinfection

AP: Tap water

ACD: Completely demineralized water with at least microbiological quality of tap water

TA: Ambient temperature

*Recommended: B. Braun Stabimed fresh

• ▶️ Follow the indications 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, brush non-visible surfaces with a suitable brush for at least 1 min. During cleaning, move mobile 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: Rinse the product thoroughly with running water (all accessible surfaces). While rinsing, move mobile components such as adjustment screws, joints, etc. Allow residual water to drain sufficiently.
• Phase III: Immerse the entire product in the disinfectant solution. While disinfecting, move mobile components such as adjustment screws, joints, etc. Irrigate cavities at the beginning of the exposure time, at least 5 times, using a suitable disposable syringe. Ensure all accessible surfaces are wetted.
• Phase IV: Rinse the product thoroughly (all accessible surfaces). During the final rinse, move mobile components such as adjustment screws, joints, etc. Irrigate cavities at least 5 times using a suitable disposable syringe. Allow residual 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).

Automatic Cleaning/Disinfection

Note: The effectiveness of the cleaning and disinfection apparatus 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 apparatus must be carried out.

Automatic Alkaline Cleaning and Thermal Disinfection

Apparatus Type: Single-chamber cleaning/disinfection apparatus without ultrasound

AP: Tap water

ACD: Completely demineralized water with at least microbiological quality of tap water

TA: Ambient temperature

*Recommendation: B. Braun Helimatic Cleaner alkaline

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

Inspection

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

Visual Inspection

• ▶️ Check that all dirt has been removed. Special attention should be paid to, for example, adjustment surfaces, hinges, shanks, deep points, and perforating grooves and the sides of chisel teeth.
• For dirty products: repeat the cleaning and disinfection process.
• ▶️ Check if the product shows damage, e.g., defective insulation, corroded parts, loose, deformed, broken, cracked, worn, fragmented, and torn parts.
• ▶️ Check if product labels are discolored or missing.
• ▶️ 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).

Function Test

❗ ATTENTION: Risk of product damage (metal degradation/frictional corrosion) if not sufficiently lubricated.

• ▶️ Lubricate moving parts (e.g., joints, sliding parts, and threaded rods) before performing the function test with a preservation 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 function.
• ▶️ Check that all moving parts (e.g., hinges, locks, sliding parts, etc.) move correctly.
• ▶️ Check rotating products (e.g., reusable drills and burs) for deformation and bending. To do this, roll the product on a smooth surface, for example.
• ▶️ Check compatibility with products with which it is combined.
• ▶️ Immediately remove the product if it does not function and send it to Aesculap Technical Service (see Technical Service).

Packaging

• ▶️ Secure the product with the lock open or at the first notch at most.
• ▶️ Place the product in the corresponding holder or basket. Ensure that existing cutting edges are protected.
• ▶️ Pack the baskets according to the sterilization procedure (e.g., in Aesculap sterile containers).
• ▶️ Ensure that the packaging is reliable and will prevent recontamination of the product during storage.

Steam Sterilization

Note: To prevent breakage due to internal fissure corrosion, sterilize instruments with a locking mechanism with the lock open or at the first locking tooth.

• ▶️ Ensure that the sterilizing medium has access to all external and internal surfaces (by opening valves and taps, for example).

Validated Sterilization Method:

• Steam sterilization by fractional vacuum method
• Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
• Steam sterilization by fractional vacuum method at 134 °C for 5 min

If sterilizing multiple products simultaneously in a steam sterilizer, ensure that the sterilizer is not overloaded beyond the manufacturer's specifications.

Storage

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