Hip endoprosthetics instrument set

Aesculap® Hip endoprosthetics instrument set Symbols on product and packages Symbol

Explanation Caution, general warning symbol Caution, see documentation supplied with the product

LEFT

left

RIGHT

Right

ANT / Anterior

Anterior

POST / Posterior

Posterior

MED / Medial

Medial

LAT / Lateral

Lateral

TOP

Top

F / FEM

Femur

SZ / SIZE

Large

S / SMALL

Small

M / MEDIUM

Medium

L / LARGE

Large

RESECT

Resection

Character/number combination, e.g. F3

Data on the instrument's size

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 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 ► Open up products with hinges.

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.

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

Preparation before cleaning ► Disassemble the product prior to cleaning.

Cleaning/disinfection

This hip endoprosthetics instrument set has been designed for primary implantation and revision implantation of Aesculap hip endoprostheses. It offers all the instruments that are used for handling the bones and soft tissue of the hip joint when a given indication is present in such a way that an Aesculap hip implants can be used.

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. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab. ► Read, observe and keep the instructions for use for hip endoprostheses and for individual instruments, as well as the surgical manual.

Product-specific safety notes on the reprocessing procedure

CAUTION

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 80 °C.

► 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/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure

Safe operation Risk of injury and/or malfunction! ► Before each use, check the instrument set for completeness and carry out a function test. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING ► Apply appropriate care when assembling or dismantling instruments.

Validated procedure

Specific requirements

Reference

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

■ Use a suitable cleaning brush. ■ 20 ml disposable syringe ■ When cleaning products with

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

movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

cloth or medical compressed air

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

Validated reprocessing procedure Mechanical cleaning/disinfection with manual pre-cleaning 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 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.