Instrument set: Excia T

Aesculap® Instrument set: Excia T Legend A Equipment tray (example) B Equipment wire basket (example) C Section of storage template sheet (example for disassemblable product, locus line points to several parts in the tray)

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

Date of manufacture

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.

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 ► Disassemble the disassemblable instruments prior to cleaning, see Disassembling/Assembling. ► Remove the storage template sheet from the tray. ► Clean profiler adapter with Woodpecker connector NT115R, NT116R and NT117R separately. Follow the instruc-

Applicable to

tions for use of the relevant article.

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

at https://extranet.bbraun.com

Cleaning/disinfection

Intended use

Product-specific safety notes on the reprocessing procedure

The instrument set provides instruments for the implantation of primary hip replacement prostheses of the corresponding implant system.

Safe handling and preparation CAUTION Federal law restricts this device to sale by or on order of a physician! ► Ensure that the instrument set is operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Follow the operating manuals of the respective implant system. ► Use the instrument set only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new instrument set, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused instruments sets in a dry, clean, and safe place. ► Prior to each use, visually inspect the contents of the instrument set for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the instrument if it is damaged or defective. Set aside the instrument immediately if it is damaged. ► Immediately replace defective or damaged instruments with original spare parts.

Safe operation

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 – Ensure that cleaning and disinfecting agents are approved for use on aluminum, plastics and stainless 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 55 °C.

CAUTION

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

Validated procedure

Specific requirements

Reference

Manual cleaning and wipe disinfection

■ Drying phase: Use a lint-free cloth or medi-

Chapter Manual cleaning/disinfection and subchapter:

cal compressed air

■ Storage template sheet Risk of gloves getting caught or damaged when handling the instruments or tray! Risk of injury from sharp, pointed or cutting instruments! ► Handle the instruments and tray with care. WARNING

Disassembling/Assembling Note Disassemblable instruments are labeled on the storage template sheet as corresponding articles, see Fig. C.

■ Chapter Manual cleaning and wipe disinfecting

Manual pre-cleaning with ultrasound and brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Instrument set

■ Pre-clean all products manually with a suitable cleaning brush.

■ An Equipment tray can be cleaned fully in the ultrasonic bath

■ Use a 20 ml disposable syringe. ■ Remove the wire basket and lid of the tray, and place these in the cleaning and disinfecting machine separately.

► Follow the instructions for use of the disassemblable instruments.

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subchapter:

■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Validated reprocessing procedure General safety instructions

Manual cleaning/disinfection

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

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

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.

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

Manual cleaning and wipe disinfecting Step

T [°C/°F]

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

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

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

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.

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

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.

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.

Phase

D–W: FD–W: RT:

t [min]

Conc. [%]

Water quality

Chemical

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature