THA Handle

Validated reprocessing procedure Aesculap® THA handle

General safety instructions

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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.

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

THA handle Rasp Instrument insertion Clamping lever Borehole for cross pin Hammer plate

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

Symbols on product and packages Oil all movable parts before each use.

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 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.

Applicable to

General information

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

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.

at https://extranet.bbraun.com

Intended use The THA handle is used in hip replacement surgeries to adapt orthopedic instruments, such as profilers, for insertion and removal procedures.

Available sizes The THA handle is available in different variants and for application with various surgical techniques.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Note Use of the THA rasp handle requires detailed knowledge of hip arthroplasty and the biomechanical situation at the hip. ► 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. ► Clean the new product after removing its transport packaging and prior to its initial sterilization (automatic). ► 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.

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

Safe operation Product-specific safety notes on the reprocessing procedure Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Danger to the patient! ► Only mechanically clean the product.

WARNING DANGER

Insert instrument into the THA handle (example: rasp) ► Open clamping lever 4, see Fig. A. ► Push rasp 2 into the instrument holder 3, see Fig. B. ► Close the clamping lever 4. ► Check that rasp 2 is firmly mounted.

Inserting and removing the instrument (example: rasp)

WARNING

Risk of injury and/or damage to the product due to incorrect application of the hammer! ► When driving the rasp in and out, using a hammer, only hit the hammer plate of the THA rasp handle.

Note A cross pin (such as ND017R) can be inserted into the holes 5 for orientation.

Remove instrument from the THA handle (example: rasp) ► Open clamping lever 4 completely, see Fig. C. ► Remove rasp 2 from the instrument holder 3.

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for aluminum, plastics, and high-grade steel for instance, according to the manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time.

► Carry out ultrasound cleaning:

– as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfection.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

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

■ Cleaning brush: e. g. TA006874 ■ 20 ml disposable syringe ■ Place the instrument in a tray

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

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

■ Keep working ends open for cleaning.

■ Place instruments in the tray with their hinges open.

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting