Monopolar HF electrodes

en ®

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

1.

Applicable to

■ GK361R ■ GK362R ■ GK363R ■ GK364R ■ GK365R ■ GK366R

2.

Intended use

Monopolar electrodes are used for monopolar cutting, coagulation and dissection in HF surgery. They are intended for use in various disciplines, including neurosurgical procedures such as ventriculoscopy.

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

Do not use in: ■ Patients wearing active implants such as pacemakers, deep brain stimulators or spinal-cord simulators. Note Use bipolar instruments where possible for patients fitted with pacemakers or other conductive implants.

5.

Risks and side effects

Within the framework of the legal obligation to provide information, the following possible known risks and side effects associated with the use of surgical instruments are highlighted. These are predominantly process-specific, not product-specific, and include unwanted damage to surrounding tissue, such as bleeding, infection, incompatibility of materials, or parts of instruments left in the patient unperceived.

6.

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.

► Follow the instructions for use of the HF device. ► For monopolar contact coagulation, take care that the HF power dose set at the HF device does not exceed 50 W. ► For simultaneous application of the HF electrode and another instrument, ensure that the widest possible dis-

tance between the working tips is maintained. Note Do not apply spray coagulation under any circumstances.

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.

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

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 detailed information on hygienically safe and material-friendly/careful processing, please refer to www.a-k-i.org Header "AKI-Brochures", "Red brochure".

8.3

Reusable products

► 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). ► Reprocess the product immediately after use, see Validated reprocessing procedure.

Influences of treatment that lead to damage to the product are not known. The product can be re-used up to 100 times with proper care and if 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.

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.

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

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.

8.5.1

Product-specific safety notes on the reprocessing procedure

The manufacturer has tested the product and verified that it can withstand 100 processing 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 sort out damaged or inoperative products and have them sent 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 plug end of the product is fitted with the following connector: pin, 4 mm, sprung. Refer to our brochures to find a compatible cable. The accessory voltage rating of the product is 1 200 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. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device.

8.4

Preparations at the place of use

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

DANGER Danger to the patient! ► Only reprocess the product using machine 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 permitted 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. ► Do not use process chemicals that cause stress cracks or brittleness in plastics.

8.6

Mechanical alkline cleaning and thermal disinfection

Note In principle, the cleaning and disinfection device must have a certified efficacy (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

FD–W

-

V

Intermediate rinse II

>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

D–W: Drinking water FD–W: Demineralized water 1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele PG 8535 2) Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Open the links and joints before placing the product on the sterilization tray. ► Connect the lumens and channels of individual parts directly to the injector unit's special flushing connector. ► 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 put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical 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

► 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!

TA013255

2020-08

V6

Change No. 60793