Femur alignment instrument NS340R NS580R

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

Aesculap® Femur alignment instrument NS340R/NS580R

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.aesculap-extra.net The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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General information

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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.

Gauge adjustment screw Gauge Slide for determining the implant size Slide adjustment screw Base unit Bottom part with condylar plate Screw for loosening and adjusting the condylar plate

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

Date of manufacture

Disassembling the product before carrying out the reprocessing procedure

Intended use The femur alignment instrument is used in operations on the knee joint. It is used to determine the size of the femur implant and for the correct alignment of the femur implant.

► Disassemble the product immediately after use, as described in the respective instructions for use.

Preparations at the place of use

Safe handling and preparation

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/ Aesculap agency.

► 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.

► 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 ► Dismantle the product prior to cleaning, see Disassembling.

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

CAUTION

Safe operation A detailed description of its use can be found in the operating manual of the corresponding Aesculap knee system (e.g. O-433 02).

Disassembling ► Unscrew slide adjustment screw 4. ► Remove slide for determining the implant size 3. ► Unscrew gauge adjustment screw 1 as far as it will go.

The gauge 2 can now only be moved to and fro slightly. ► Unscrew screw for loosening and adjusting the condylar plate 7 as far as it will go. ► Withdraw bottom part with condylar plate 6 in the direction of the screw for loosening and adjusting the con-

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 e.g. on aluminum, plastic materials and stainless steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

► 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. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – 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.

dylar plate 7 out from the base unit 5.

Validated cleaning and disinfection procedure

Assembling Note The femur rotation angle can be individually adjusted. Take into account whether it is a right or left knee. ► Push bottom part with condylar plate 6 into the base unit 5. ► Tighten screw for loosening and adjusting the condylar plate 7. ► Push slide 3 onto base unit 5 . ► Tighten slide adjustment screw 4. ► Fasten the gauge2 using the gauge adjustment screw 1 tightly onto the base unit 5.

Validated procedure

Specific requirements

Reference

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Place the instrument in a tray

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter: with ultrasound and brush cleaning and thermal disinfecting

Manual cleaning/disinfection Risk to patients! ► The product must only be cleaned mechanically!

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.

■ Chapter Manual pre-cleaning ■ Chapter Mechanical alkaline

Note To adjust the femur size on the bone, the slide adjustment screw 4 must be untightened again.

Validated reprocessing procedure

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

DANGER

Mechanical cleaning/disinfection with manual pre-cleaning 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). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.