IQ RESET knee instrument set

Validated reprocessing procedure Aesculap® IQ RESET knee instrument set

General safety instructions

Symbols on product and packages

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.

Caution, general warning symbol Caution, see documentation supplied with the product

Mechanical Cleaning

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

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

Manual Cleaning

Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Pre-cleaning with a brush

General information

Pre-cleaning with a brush followed by mechanical cleaning

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Manual or mechanical cleaning

Scope These instructions for use apply to all size-specific configurations of instrument sets for the implantation of primary knee implant systems for the models Columbus, Vega and e.motion.

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.

Preparations at the place of use

Intended use The IQ RESET knee instrument set is used for the implantation of primary knee replacement prostheses. The instrument set contains all necessary instruments for the preparation of the implant bed, for the function checks and for the final implantation of the components.

► 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

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Impaired operation outcome as a result of incorrectly selected instruments! ► Ensure that the instrument set is appropriate for the knee system used.

Note Fixation screws which permanently connect the various components must not be disassembled. ► Remove the storage template sheet prior to cleaning.

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

WARNING ► Ensure that the IQ RESET knee instrument set is used only by persons with the requisite training, knowledge, or

experience. ► Read, follow, and keep the instructions for use. ► Follow the operating manuals of the respective knee system. ► Use IQ RESET only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new IQ RESET, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused IQ RESET sets in a dry, clean, and safe place. ► Prior to each use, visually inspect the contents of the IQ RESET for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the instrument if it is damaged or defective. Set aside the instrument immediately if it is damaged. ► Immediately replace defective or damaged instruments with original spare parts. ► Ensure that a sterile instrument set is available for the bordering sizes (next size up and next size down).

Safe operation

► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► 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.

Validated cleaning and disinfection procedure Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

WARNING Risk of gloves getting caught or damaged when handling the instruments or tray! Risk of injury from sharp, pointed or cutting instruments! ► Handle the instruments and tray with care. WARNING

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 allowable temperature of 55 °C.

The IQ RESET instruments are stored in cleaning storage devices and can be cleaned in the cleaning storage devices. ► Only clean instruments together with other Aesculap instruments validated for cleaning in the cleaning storage device. ► Complex instruments (e.g. saw guides) or instruments inserted in the medullary cavity (IM) (e.g. drills, reamers and rasps) must be cleaned manually according to the following note. Note For each individual instrument, the validated reprocessing procedure is available from the Aesculap Extranet (https://extranet.bbraun.com) using the relevant article number. The size-specific instrument sets also contain small labels with symbols for reprocessing, known as IFR (instructions for reprocessing), as well as the number of the instructions for use for cleaning the respective contents of the set.

Inspection, maintenance and checks ► Allow the IQ RESET to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the IQ RESET is dry, clean, operational,

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the instruments if they are wet or damp. ► Repeat cleaning and disinfection of instruments that still show impurities or contamination. ► Carry out a function check of the instruments and storage device. ► Immediately sort out damaged or inoperative instruments and have them sent to AesculapTechnical Service, see Technical Service. ► Check for compatibility with associated products.