Insertion instrument for hip endoprosthesis stems

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

Aesculap® Insertion instrument for hip endoprosthesis stems

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.

Legend

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

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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.

Clamping lever Handle Tensioning wedge Polygon adapter Hexagon adapter

General information

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

Intended use The insertion instrument is used for implanting hip endoprosthesis stems, using an appropriate adapter intended for this purpose. Observe the instructions for use of the implant. The insertion instrument allows rotation-free adaptation, positioning and implantation of the implant. The insertion instrument is separated from the implant without stress on the implant environment and the implant Due to the limited pulling strength of the instrument, it can not be used for explanting the prosthesis stem.

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.

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.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use.

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.

Preparation before cleaning

Safe operation

► Dismantle the product prior to cleaning, see Disassembling.

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

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

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

CAUTION

Important notes ► To ensure that clamping lever 1 can be opened after insertion, make certain that the insertion instrument is cor-

rectly positioned on the prosthesis.

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 60 °C.

► Remove the insertion instrument as soon as the implant has been inserted.

Implantation ► Move clamping lever 1 of the insertion instrument to adapting position (90°), see Fig. A. ► Insert the insertion instrument in the implant port as far as it will go. ► Move clamping lever 1 to touch handle 2 so that the implant is clamped in the insertion instrument.

The implant is automatically set in axial alignment with the insertion instrument. ► To separate the insertion instrument from the implant: Open clamping lever 1 and detach the insertion instrument in the direction of the stem.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush, e.g. TA006874 ■ 20 ml disposable syringe ■ When cleaning instruments 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.

Disassembling

► Insert clamping lever 1 in handle 2 and mildly press on it in assembly position, see Fig. C. ► From the lower end of the instrument, insert tensioning wedge 3 in the insertion instrument and turn it to the

or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush, e.g. TA006874 ■ 20 ml disposable syringe ■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

right as far as it will go. In this way tensioning wedge 3 is fastened. ► Align the beveled surfaces of tensioning wedge 3 and move clamping lever 1 beyond the ratchet resistance to its adaption position, see Fig. B.

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Place instruments in the tray with

Note If there is no noticeable ratchet resistance, the tensioning wedge needs to be tightened further.

Validated reprocessing procedure

immersion disinfection

■ Drying phase: Use a lint-free cloth

► Move clamping lever 1 beyond a ratchet resistance to its assembly position (180°), see Fig. C. ► To release tensioning wedge 3, turn it to the left and remove it downward. ► Pull out clamping lever 1 from handle 2.

Assembling

■ Chapter Manual cleaning with

their hinges open.

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 For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.

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