Reusable electrode handles (monopolar)

Connecting the handle at the HF device

Cleaning/disinfection

► Insert the plug in the appropriate monopolar output socket of the HF device.

Product-specific safety notes on the reprocessing procedure

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). ► Do not exceed the maximum permitted cleaning temperature of 93 °C.

Immersion treatment in a 3 % H2O2 solution for approx. 5 minutes is a particularly effective and gentle method to dissolve encrustations from HF instruments. The debris can be removed manually with a soft brush. This is followed by the conventional reprocessing steps. ► Do not clean the product in an ultrasound bath. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

Validated cleaning and disinfection procedure

Fig. 6

E.g. inserting the coax plug in the monopolar output socket (GN640)

Validated procedure

Specific requirements

Reference

Mechanical alkaline cleaning and thermal disinfection

■ Place the instrument in a

Chapter Mechanical cleaning/disinfecting and sub-chapter:

tray that is suitable for cleaning (avoiding rinsing blind spots).

Activate HF

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

When using a handle with activation keys, the HF output can be activated by pressing the keys. ► Press the yellow key: activation of the “Cutting” operating mode. ► Press the blue key: activation of the “Coagulating” operating mode.

Mechanical cleaning/disinfecting

Note For correct functioning of the HF device, configure the device for handle activation according to the instructions for use of the HF device!

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

When using a handle without keys, the HF output of the HF device is controlled by a foot switch connected to the HF device.

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Validated reprocessing procedure

Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound

Note Note the validated processing procedure brochure (AVA-V6), available separately, see Validated cleaning and disinfection procedure.

Phase

General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

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.

– pH = 11*

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

III

Intermediate rinse

>10/50

1

FD-W

-

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation.

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Note If there is no final sterilization, then a virucidal disinfectant must be used. 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.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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 measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for 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 the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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 of 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 surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Inspection, maintenance and checks

Disassembling the product before carrying out the reprocessing procedure

► Validated sterilization process

► Remove the working electrodes from the handle.

– Disassemble the instrument – Steam sterilization through fractionated 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 ► 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.

► 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. ► Check for compatibility with associated products.

Packaging ► Place the product in its holder or on a suitable tray. ► 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.

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).

Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

Preparation before cleaning ► Disassemble the product prior to cleaning.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.

Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure.

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Always adhere to national regulations when disposing of or recycling the product or its components! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass contains instructions on disassembly of the product, as well as information for proper disposal of environmentally hazardous components) Any product carrying this symbol must be disposed of separately through dedicated electrical and electronic devices recycling. Within the EU, such disposal is taken care of by the manufacturer free of charge.

Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.

Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap agency, see Technical Service.

Storage

Distributor in the US/Contact in Canada for product information and complaints

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

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

Technical Service Risk of injury and/or malfunction! ► Do not modify the product.

TA-Nr. 022261

WARNING ► 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] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Accessories/Spare parts Note Information about accessories and spare/replacement parts can be found in Aesculap brochure C-304-81.

Technical Data Classification acc. to Directive 93/42/EEC Designation

Class

Reusable electrode handles (monopolar) without keys

IIa

Reusable electrode handles (monopolar) with keys

IIb

Conforming to standard IEC/DIN EN 60601-2-2

Ambient conditions Storage and transport conditions Relative humidity

0 % to 75 %, no condensation

Ambient temperature

-20 °C to +50 °C

Atmospheric pressure

500 hPa to 1 600 hPa

Direct sunlight

Protect against direct sunlight

09/12

V6

Änd.-Nr. 45195