Bipolar electrodes

en ®

Aesculap Bipolar electrodes Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

1.

Applicable to

■ GK343R ■ GK344R ■ GK345R ■ GK360R

2.

Intended use

The bipolar electrodes are used for hemostatic coagulation in HF surgery. They are intended for use in various disciplines, including neurosurgical procedures.

3.

Indications

Indications, see Intended use. Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

4.

Contraindications

None known.

5.

Risks and side effects

Within the framework of the legal obligation to provide information, we draw attention to the following possible risks and side effects, as known by the manufacturer in connection with the use of surgical instruments. These are predominantly process- and not product-specific and include unwanted damage to surrounding tissue, which manifest, e.g. as bleeding, infection, incompatibility of materials or parts of instruments that remain unnoticed in the patient.

8.

Validated reprocessing procedure

8.1

General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. The specified chemistry was used for validation.

8.2

8.3

Safe handling and preparation

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar). ► Sterilise the product immediately after use, see Validated reprocessing procedure. WARNING Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ► Observe the safety guidelines in the instructions for use of the HF device. WARNING Thermal injuries to patients/users due to insufficient insulation of leads in active accessories! ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage does match or not exceed the accessory voltage rating specified for the product. The manufacturer has tested the product and verified that it can withstand 100 reprocessing cycles. Durability in clinical practice depends on individual intraoperative use and hospital specific processing conditions. ► Prior to each use, inspect products for: damage or surface changes to the insulation. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Adjust the HF power output to the intended surgical intervention. Take into account clinical experience or ref-

erence values. ► 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. The product is furnished with the following connection on the plug side: Aesculap Flat connection. Refer to our brochures to find a compatible cable. The accessory voltage rating of the product is 600 Vp. 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. ► 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. ► When using an HF instrument together with another instrument, the clearance between the working ends must be guaranteed to be as large as possible. ► In the case of bi-instrumental work with the MINOP inVent trocar, implement the HF instrument last if possible. ► In the case of bi-instrumental work with the MINOP inVent trocar, remove the HF instrument from the trocar first if possible.

7.

Safe operation

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

Reusable products

Processing conditions are not known to cause damage to the product. Subject to appropriate care, the product can be re-used up to 100 times - provided that it is undamaged and clean. The user shall be responsible for any further reuse. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

8.4

6.

General information

Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion. Therefore, do not exceed a period of 1h between use and processing, make sure pre-cleaning temperatures are <45°C to prevent clotting, and do not use disinfectants that can cause clotting (active ingredient: aldehyde, alcohol). 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. 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 damage to metallic products. These must be removed by rinsing thoroughly with demineralized 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 processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ 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 ► For further detailed information on hygienically safe and material-friendly/sustainable reconditioning, see www.a-k-i.org heading "AKI Brochures", "Red Brochure".

Preparations at the place of use

► If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),

using a disposable syringe, for example. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the wet product in a sealed waste container and take it to be cleaned and disinfected within 1h.

8.5

Cleaning/disinfection

8.5.1

Product-specific safety notes on the reprocessing procedure

DANGER Danger to the patient! ► Process the product exclusively with mechanical cleaning. DANGER Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for use, for example, on aluminum, plastic materials, and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permissable cleaning temperature of 55 °C. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids. ► Do not use process chemicals that result in stress cracks and embrittling in plastics.

8.6

Alkaline machine cleaning and thermal disinfection

Note As a matter of principle, the efficacy of the cleaning and disinfection device must be certified (e.g. in accordance with EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. Type of device: Single-chamber cleaning/disinfection device without ultrasound1) Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 % Working solution2)

III

Neutralization

>10/50

2

FD–W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate rinse I

>10/50

1

DI–W

-

V

Intermediate rinse II

>10/50

1

FD–W

-

VI

Thermal disinfection

90/194

5

DI–W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: Drinking water DI–W: Demineralized water 1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele PG 8535 2) Cleaner with prion inactivating effect (see technical information Dr. Weigert neodisher® SeptoClean)

► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Store product with open joint in the sieve basket. ► Connect individual parts with lumens and channels directly to the special flushing connection of the injector

trolley. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

8.7

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see Technical Service.

8.8

Packaging

► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

8.9

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 fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

9.

Technical Service

WARNING Risk of injury and/or malfunction! ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

10.

Disposal

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

TA013449

2020-08

V6

Change No. 60793