Acetabular reamers and standard reamer shafts

Validated reprocessing procedure Aesculap® Acetabular reamers and standard reamer shafts

General safety instructions

Legend

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.

A B C D 1 2 3 4 5

Standard shaft with non-navigated sleeve Standard shaft with navigation sleeve Full profile reamer MIOS low cross-section reamer Rigid body adapter (for navigation) Marking (for insertion depth) Adapter for reamer heads Locking mechanism Locking sleeve

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

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. 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

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 acetabular reamers are used for preparing the implant bed for spherical hip cups.

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.

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

Safe operation Shaft adapters with Harris, AO and Zimmer connectors are available for the individual motor handpieces. The standard shaft is available either with a non-navigated sleeve, see Fig. A, or with a navigation sleeve, see Fig. B. They are powered preferably by motor handpieces with a maximum rotational speed of 300/1 min.

WARNING

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.

Breach of the pelvic floor or excessive size of the acetabulum due to application of a sharp reamer or excessive pressure! ► Apply new reamers with appropriate caution. ► Take care to apply appropriate pressure.

► Prepare the acetabulum step by step, starting with a small reamer. ► Make certain that the reamer profile is hemispherical.

► 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

Note Normally, the end face of a full-profile reamer, see Fig. C, corresponds to the correct insertion depth of the hip cup. For MIOS low cross-section reamers, see Fig. D, the insertion depth is indicated by black marking 2. ► When the reamer basket is full: Stop the process and empty the reamer basket.

CAUTION

Note A full reamer basket reduces the cutting performance and makes it difficult to open the shaft coupling.

Disassembling Releasing the reamer head ► Pull back locking mechanism 4 and loosen the reamer head.

This releases the reamer head.

Dismounting the locking mechanism, see Fig. II

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 (e.g. aluminum, plastics, 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 80 °C.

► 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. ► If bone or tissue residue is present, the instrument must be pre-cleaned manually (using a brush).

Validated cleaning and disinfection procedure

► Turn and push back locking sleeve 5. ► Pull back locking mechanism 4.

Validated procedure

Specific requirements

Reference

Assembling

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and sub-chapter:

Mounting the locking mechanism, see Fig. I ► Push locking mechanism 4 into adapter for reamer heads 3. ► Push forward and turn locking sleeve 5.

■ Chapter Manual cleaning with immersion disinfection

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

Coupling a reamer head

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

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Chapter Mechanical alkaline

■ Place products in the tray with

► Put the reamer head on adapter for reamer heads 3 and turn the reamer head.

their hinges open.

The reamer head is locked.

cleaning and thermal disinfecting

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

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