YASARGIL aneurysm clip applier forceps

Use with locking function

Aesculap® YASARGIL aneurysm clip applier forceps Legend 1 2 3 4 5 6 7

Inserting the aneurysm clip and engaging the lock ► Insert the aneurysm clip into jaws 1. ► Press lock push button 4 while compressing branches left/right 2, see Fig. A.

Lock 5 is engaged, see Fig. B. With lock 5 engaged, jaws 1are tensioned so that the aneurysm clip is lightly clamped in between jaws 1.

Releasing the lock

Jaw part Branches left/right Color-coding button Lock pushbutton Lock Spring Clip applier forceps

► Compress branches left/right 2 to the positive stop.

Jaws 1 of clip applier forceps 7 closes and the aneurysm clip opens. Spring 6 switches automatically to the unlocked position, see Fig. C.

Detach the clip applier forceps from the aneurysm clip ► Fully release branches left/right 2, see Fig. D.

Jaw piece 1 of clip applier forceps 7 opens and the aneurysm clip closes. ► Detach clip applier forceps 7 from the aneurysm clip.

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

Validated reprocessing procedure General safety notes Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

Intended use The YASARGIL aneurysm clip applier forceps are used for opening, closing and applying Aesculap YASARGIL aneurysm clips. Note In the following text, Aesculap YASARGIL aneurysm clips are referred to as aneurysm clips.

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.

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. 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

Contraindications 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.

Available sizes 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 the YASARGIL aneurysm clip brochurefor clip applier forceps.

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. ► Clean the new product mechanically after removing its transport packaging and 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.

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 ► Open up products with hinges.

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 dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Safe operation Cleaning/disinfection 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.

CAUTION

Product-specific safety notes on the reprocessing procedure Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

► Observe color of color-coding button 3.

DANGER Size

Titanium aneurysm clips

Phynox aneurysm clips

Standard

Blue

Black

Mini

Red

Gray

Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. DANGER

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 or Standard, respectively). Locking function Note The clip applier forceps can be used with or without locking function.

Use without locking function ► Insert the aneurysm clip into jaw piece 1. ► Compress branches left/right 2.

The inserted aneurysm clip opens. ► Fully release branches left/right 2. The aneurysm clip closes. ► Detach clip applier forceps 7 from the aneurysm clip.

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 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.