Femur trial implant impactor instrument Instructions for Use

Aesculap® Femur trial implant impactor instrument NS371R Legend 1 Base unit 2 Handle 3 Femur trial implant

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

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.a-k-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.

Date of manufacture

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

Intended use

► Dismantle the product prior to cleaning, see Disassembling.

The femur trial implant impactor instrument is used in operations on the knee joint.

Cleaning/disinfection

Safe handling and preparation Product-specific safety notes on the reprocessing procedure

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. CAUTION

► 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.

Safe operation ► Insert the hook-shaped end of the base unit 1 into the corresponding receptacle of the femur trial implant 3, see

Fig. 2. ► Turn handle 2 clockwise. ► Femur trial implant 3 is attached to the femur impactor instrument. ► Position the femur trial implant 3 on the prepared bone. ► Hammer in the femur trial implant 3 using the femur impactor instrument.

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.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

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

■ Suitable cleaning brush ■ 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).

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Disassembling ► Unscrew handle 2 from the base unit 1, see Fig. 1.

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

Assembling Note Do not screw in the handle too far, otherwise the femur trial implant cannot be inserted.

DANGER

► Screw handle 2 into base unit 1.

The femur trial implant impactor instrument is ready for use.

Validated reprocessing procedure General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

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.

Manual pre-cleaning with a brush

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.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

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.aesculap-extra.net The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

General information 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.

D–W: Drinking water RT: Room temperature *Recommended:BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.