Bipolar coagulation forceps

The accessory voltage rating and plug connection of the product:

en ®

Aesculap Bipolar coagulation forceps 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 for bipolar coagulation forceps in the versions: Standard, Rose Gold Non-Stick, Sintram, BiProtect, Pivot-Point, Caspar, Yasargil, Irrigation and Micro and Laboratory. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Applicable to

Accessory voltage rating

Plug connection

■ CASPAR Coagulation Forceps - Reusable ■ Sintram Non-Stick Bipolar Forceps - Reusable ■ Micro and Laboratory Forceps - Reusable ■ Pivot-Point Bipolar Forceps - Reusable ■ BiProtect - Anti Collateral Damage Forceps ■ YASARGIL Coagulation Forceps - Reusable ■ Irrigating Coagulation Forceps - Reusable

600 Vp

Aesculap flat connector

■ Standard Coagulation Forceps - Reusable

600 Vp

Aesculap round male connector* EURO flat connector* Aesculap flat connector* *see brochure C30481

■ Rose Gold Non-Stick Bipolar Forceps, Single Use

550 Vp

Us round male connector

■ Rose Gold Non-Stick Bipolar Forceps - Reusable

600 Vp

Us round male connector

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: DANGER Shows a possible threat of danger. If not avoided, death or severe injuries may result. 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.

2.

Clinical use

Note The short summary of safety and clinical performance of the product is available in the European Database for Medical Products (EUDAMED).

2.1

Areas of use and limitations of use

2.1.1

Intended use

Bipolar forceps are used for styptic coagulation and for gripping and preparing tissues during surgical interventions, including neurosurgery.

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.

The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2). To avoid HF burns: ► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated. ► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories. ► Before each use, inspect products visually for: damage and surface changes on the insulation. ► Never place the product on or next to the patient. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device. ► Follow the instructions for use of the HF device. Check forceps with coated electrodes, working tips, e.g. Rose Gold Non-Stick Forceps, before every use to ensure that the coating is still complete and opaque. If the coating is incomplete, do not use the forceps and discard them.

2.2.3

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile products Applicable for Rose Gold Non-Stick Forceps, Single-Use: GK501SU to GK510SU. The product is gamma-sterilized and ships in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. ► Do not reuse the product.

The preparation of the product affects its functionality. Risk of injury, illness or death due to contamination and/or impaired functionality of the product. ► Do not reprocess the product.

2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components, particularly the ceramic insulation of the tips and the insulation of the forceps limbs. ► Always carry out a function test prior to each use of the product.

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.

3.

Validated reprocessing procedure

3.1

General safety information

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.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

2.2.2

Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The specified chemistry was used for validation.

Product

Product-specific safety information Risk of breakage at the ceramic insulation (BiProtect forceps only). ► To avoid damage to the working tip, especially to the ceramic insulation: do not apply excessive forces and protect the working tip from impacts and knocks. ► Prior to each application inspect the ceramic insulation for completeness and/or cracks. ► For storage and processing, always cover the forceps tips with the tip protection supplied for this purpose. Sparks may be created during proper use of the HF instrument, which may lead to ignition or explosion of flammable gases. ► Observe the safety guidelines in the instructions for use of the HF device. HF instruments may lead to thermal damage to the patient/user. ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage is equal to or less than the accessory voltage rating specified for the product. ► Adjust the HF power output appropriately for the intended procedure, ► Select the lowest possible HF power output. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab.

Note For patients with Creutzfeld-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General notes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 1 hours should be left between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non 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 damage to the products in case of non stainless steel. These must be removed by rinsing thoroughly with desalinated water and then drying. Perform 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 reprocessing the product. All of the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be 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 surface 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

Single-use products

3.7.2

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine without ultrasound1)

Applicable for Rose Gold Non-Stick Forceps, Single-Use: GK501SU to GK510SU. ► Do not reuse the product.

Phase

Step

The preparation of the product affects its functionality. Risk of injury, illness or death due to contamination and/or impaired functionality of the product. ► Do not reprocess the product.

D [°C/°F]

I

Pre-rinse

<25/77

3

D–W

-

3.4

II

Cleaning

55/131

10

FD–W

Alkaline cleaner

Reusable products

Evidence of biocompatibility and processibility for the products was produced by the manufacturer after the following processing cycles. Any additional reuse falls under the responsibility of the user. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection. Applicable to

20

■ YASARGIL Coagulation Forceps - Reusable ■ Irrigating Coagulation Forceps - Reusable

75

Chemistry

Utility solution pH ~ 112) III

Neutralization3)

>10/50

2

FD–W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate irrigation I

>10/50

1

FD–W

-

V

Intermediate irrigation II3)

>10/50

1

FD–W

-

VI

Thermal disinfection

90/194

5

FD–W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

■ Rose Gold Non-Stick Bipolar Forceps – Reusable

25

DW: FD–W:

Drinking water Fully desalinated water The following cleaning and disinfection device was used to verify cleanability: Miele PG 8535 Dr. Weigert neodisher® SeptoCleanwas used to verify cleanability. Due to the high pH value of the cleaner, the neutralization and the second intermediate irrigation was used.

1) 2) 3)

Preparation at the place of use

► If applicable, rinse surfaces that are not accessible for visible inspection (preferably with highly purified water),

for instance using a disposable syringe. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Put the wet product into a closed disposal container and have it transferred to cleaning and disinfecting within

1 h.

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

Danger to the patient! ► Only reprocess the product by mechanical cleaning. Risk to patient due to cross contamination! ► Contaminated products already used in the ZNS – Do not clean together with clean products in the same cleaning container, – Do not use in other areas, insofar as they have not been cleaned with alkaline cleaner (pH ~11). 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, – that are approved for aluminum, plastics, stainless steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► For storage and processing, always cover the BiProtect forceps tips with the tip protection supplied for this pur-

pose. Immersion treatment in a 3% H2O2 solution for approx. 5 minutes is a particularly effective and gentle method for dissolving encrustations on HF instruments. Subsequently, the debris can be removed by hand, with a medium-hard brush and or in an ultrasonic bath. This is followed by the next standard reprocessing steps.

3.7

Water quality

Processing cycles

■ CASPAR Coagulation Forceps - Reusable ■ Sintram Non-Stick Bipolar Forceps - Reusable ■ Micro and Laboratory Forceps - Reusable ■ Pivot-Point Bipolar Forceps – Reusable ■ BiProtect – Anti Collateral Damage Forceps ■ Standard Coagulation Forceps – Reusable

3.5

t [min]

Mechanical cleaning/disinfection with manual pre-cleaning

Note It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (e.g. fulfillment of EN ISO 15883). Note The washer-disinfector machine used for processing must be serviced and checked at regular intervals.

3.7.1

Manual pre-cleaning with brush

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

RT (cold)

>15

1

D–W

B. Braun Stabimed® fresh

II

Rinsing

RT (cold)

1

-

D–W

-

► Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). ► Place the product on the tray with all product links and joints open. ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.8

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. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes for deformities. ► Ensure that the forceps tips close parallel to each other and without misalignment. ► 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. ► Check coatings on electrodes and discard if damaged. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.8.2

Functional test

► Check that the product functions correctly. ► Check all moving parts for complete mobility. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.9

Packaging

► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that tips are protected. ► 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.

3.10 Steam sterilization ► Make certain that all external and internal surfaces will be exposed to the sterilizing agent. ► 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 Note The product is also suitable for sterilization at 134 °C/holding time 18 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.

3.11 Storage DW: RT:

Drinking water Room temperature

► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

4. Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Ensure that all accessible surfaces are wet. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed. ► If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush. ► Mobilize non-rigid components, such as set screws and hinges, during cleaning. ► Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml). Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing.

Technical service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. 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. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents the product from causing injury. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA012932

2021-01

V6

Change No. 64152