YASARGIL Aneurysm Clip Applier Forceps Instructions for Use/Technical Description

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

Aesculap® YASARGIL aneurysm clip applier forceps

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.

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General information

1 2 3 4

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.

Jaw part Branches left/right Color-coding button YASARGIL aneurysm clip applier forceps

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

Intended use

Intended use The YASARGIL aneurysm clip applier forceps is used for opening, closing and applying Aesculap

YASARGIL aneurysm The YASARGIL aneurysmclips. clip applier forceps is used for opening, closing and applying Aesculap YASARGIL aneurysm clips.The clip appliers are MR Unsafe. Note Aesculap In the following text, YASARGIL aneurysm clips are referred to as aneurysm clips.

Available sizes

Disassembling the product before carrying out the reprocessing procedure

All clip applier forceps are marked according to size (Mini or Standard) and clip material (Phynox or titanium) so that their correct application with aneurysm clips of the respective size and material is ensured. For detailed information on the available sizes, see YASARGIL aneurysm clips/applier forceps brochure.

► Open up products with hinges.

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.

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.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Safe operation

CAUTION

Damage to, imprecise functioning and incorrect closing force of the aneurysm clips caused by using the wrong applier forceps! ► Use aneurysm clips only with the matching applier forceps; note the respective color of the color-coding button. ► Apply long aneurysm clips only with the long clip applier forceps (see TA011547).

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 plastic materials. – 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. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.

Validated cleaning and disinfection procedure

► Observe color of color-coding button 3.

Titanium aneurysm clips

Phynox aneurysm clips

Standard

Blue

Black

Mini

Red

Gray

Use clips and clip applier forceps only in the following combinations: ■ Phynox aneurysm clips with the clip applier forceps for Phynox aneurysm clips ■ Titanium aneurysm clips with the clip applier forceps for titanium aneurysm clips ■ Mini and Standard aneurysm clips must be applied with the clip applying forceps of the appropriate size (Mini and Standard) ► Insert the aneurysm clip into jaws 1. ► Compress the branches left/right 2, see Fig. A. The inserted aneurysm clip opens. ► Fully release branches left/right 2, see Fig. B. The aneurysm clip closes. ► Detach clip applier forceps 4 from the aneurysm clip.

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ When cleaning products with

Chapter Manual cleaning/disinfection and sub-chapter: immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with

Note In order to avoid the clip dropping out whilst being handed from the surgical nurse to the surgeon, do not open the clip applier forceps during handover.

Validated reprocessing procedure

■ Chapter Manual cleaning with

movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline

their hinges open.

cleaning and thermal disinfecting

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note Sincepatients no reprocessing methods have been validated for removal of transmissible spongiform encephalopathy agents For with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, (TSE) observe thefrom relevant medical devices, this device should not bereprocessing used for patients known or suspected TSE agent disease, including CJD and vCJD. national regulations concerning the of with products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 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.

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.