Landolt bipolar coagulation forceps

► 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.

®

Aesculap Landolt bipolar coagulation forceps

Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Legend 1 2 3 4 5

Landolt bipolar coagulation forceps Handle Pushbutton Movable handle part Inner guide

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

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

Disassembling ► Close moveable handle part 4. ► Press and hold pushbutton 3. ► Simultaneously, push up moveable handle part 4. ► Extract inner guide 5 from handle 2, see Fig. 1.

Applicable to ■ GK560R ■ GK561R ■ GK580R ■ GK581R

Assembling

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at https://extranet.bbraun.com

Intended use

► Make certain that moveable handle part 4 is closed and pushed up. ► Insert inner guide 5 first into handle 2, then into moveable handle part 4. ► With inner guide 5 inserted, pull down moveable handle part 4 so that pushbutton 3 engages. ► Check that moveable handle part 4 is securely locked, see Fig. 2.

Validated reprocessing procedure

The bipolar coagulation forceps are used for hemostasis with HF current in microsurgical and neurosurgical procedures.

General safety notes

Indications, see Intended use.

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

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

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.

Contraindications

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.

Indications

None known.

Risks and side effects As part of the legal duty to inform, the following typical risks and side effects associated with the use of surgical instruments are referred to. These are predominantly procedure-specific, non product-specific and not limited to unwanted damage to surrounding tissue resulting in e.g. bleeding, infection, material incompatibilities or instrument parts remaining unnoticed in the patient, etc.

Safe handling and preparation CAUTION Federal law restricts this device to sale by or on order of a physician! ► 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. 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

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.

Note For up-to-date information about 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.

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 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: ■ Optical changes in 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 surface and could cause corrosion ► For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use.

Preparations at the place of use ► If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),

The manufacturer has tested the product and verified that its insulation can withstand 20 reprocessing cycles. In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions. ► Prior to each use, inspect products for: damage or surface changes to the insulation. ► Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see Technical Service. ► Adjust the HF power output (and argon flow rate) to the intervention to be carried out. Take into account clinical experience or reference 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 plug end of the product is fitted with the following connector: pin, 1.6 mm, sprung. 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. ► Prior to each use, visually inspect the product for: damage or surface changes to the insulation. ► Never place the product on or next to the patient.

using a disposable syringe, for example. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning. DANGER Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. DANGER