Plastic storage tray for aneurysm clips

Aesculap® Plastic storage tray for aneurysm clips Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

Intended use The Aesculap plastic storage tray for aneurysm clips is intended exclusively for the organization, storage and safe transport of Aesculap YASARGIL aneurysm clips. To ensure the sterility of the aneurysm clips, additional adequate packaging for sterile materials must be used. The purpose of the aneurysm clips is described in the respective instructions for use.

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. ► Follow general guidelines and aseptic principles when handling contaminated items that have undergone or are to undergo sterilization.

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.

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

WARNING

Note To prevent any avoidable contamination of the aneurysm clips, and to save the considerable time and effort involved in removing the clips from the plastic storage tray, cleaning and disinfecting and, finally, re-sorting them into the storage tray, handle the loaded storage tray with extreme care before and during surgery. CAUTION

Safe operation Loading aneurysm clips into the storage tray Each hollow in the storage tray has a recess for an identification tag assigned to it, marked with a bracket “[ ]”. ► Prior to filling the storage tray for the first time, define the allocation of the compartments and mark them with the appropriate identification tags. ► Thoroughly clean (manually or mechanically) the empty plastic storage tray, see Validated cleaning and disinfection procedure. ► Carefully sort the aneurysm clips into the appropriate compartments, according to the art. no. shown on the identification tags. ► To ensure that the aneurysm clips cannot be damaged when the lid is put on and closed, do not overfill the storage compartments with aneurysm clips (max. number depending on their shape and size). ► When putting on the lid, make certain that the profiles in the lid precisely fit and engage in the compartments in the base of the storage tray, and that the inscription “This side up” is visible on the top of the lid. ► Always close the lid before transporting the loaded plastic storage tray.

CAUTION

Risk of insufficient sterility due to dried-in dirt and residual germs! ► Do not clean the aneurysm clips in the plastic storage tray. Observe the instructions concerning cleaning and disinfection, as given in the instructions for use of the aneurysm clips. ► Clean/disinfect (manually or mechanically) the plastic storage tray only when it is completely empty. ► For cleaning and disinfection, separate the lid from the base of the storage tray. 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 93 °C. Damage to the product caused by unsuitable cleaning and disinfecting agents! Phenolic and enzymatic cleaning and disinfecting agents are suitable for the Aesculap plastic storage tray only under certain conditions and at low concentrations (max. 0.5 %). ► To prevent stress cracking, do not use rinsing agents that contain tensides. ► Do not use solvents such as acetone or benzine. ► Always observe the manufacturers’ instructions concerning cleaning and disinfecting agents.

Contaminated aneurysm clips

Minimum requirements for handling the aneurysm clips Note The user is responsible for the proper handling of the product. Additional precautions may be necessary, depending on conditions at the location where the product is used. ► To prevent contamination of the aneurysm clips, avoid contact with the unused aneurysm clips and the plastic

storage tray under all circumstances. ► Always use sterile forceps that have not been contaminated with blood or body fluids to take aneurysm clips from the storage tray during surgery. ► Put on and close the lid after aneurysm clips have been taken from the storage tray. Cover the plastic storage tray with a sterile cloth and keep it available in a place as far as possible away from the operating field. ► After use, put the plastic storage tray into a sterile container and close the sterile container for transport to CSSD.

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

► Set aside contaminated aneurysm clips and clean and disinfect them, or dispose of them, according to their

instructions for use.

Contaminated plastic storage tray ► Reprocess the contaminated plastic storage tray as soon as possible. ► Remove aneurysm clips from the plastic storage tray. ► Separately the lid from the base component of the plastic storage tray and clean and disinfect (manually or

mechanically) individually. ► Carry out ultrasound cleaning:

– as an effective mechanical supplement to manual cleaning/disinfecting, – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfecting, – as an integrated mechanical support measure for mechanical cleaning/disinfecting, – for additional cleaning of products with residues left after mechanical cleaning/disinfection. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids. ► 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 For mechanical cleaning: Note Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components. Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ 20 ml disposable syringe ■ When cleaning products with

Chapter Manual cleaning/disinfection and sub-chapter:

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

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.

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.

■ Chapter Manual cleaning with immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with their hinges open.

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting