Metha extraction instrument

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

Aesculap® Metha Metha extraction instrument

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.

Legend

General information

1 2 3 4 5 6 7 8 9

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.

Extraction instrument Support handle Turning handle Catches for the support handle on the turning handle Mounting wheel Housing Sheath Standoff forks Prosthesis stem

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

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 extraction instrument for modular neck components is used in hip-endoprosthetic interventions with the Metha modular short-stem prosthesis. It serves for separating the modular neck component from the prosthesis stem.

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

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Applying the Metha extractor instrument requires precise knowledge in hip endoprosthetics 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. ► 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.

► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure Risk to patients! ► The product must only be cleaned mechanically! DANGER

CAUTION

Safe operation ► Apply extraction instrument 1 in its initial position on the end plane of the prosthesis stem 9. Ensure that the

standoff forks 8 are positioned correctly, see Fig. 1. ► Turn turning handle 3 clockwise until standoff forks 8 are spread widely enough that they fit firmly between the

prosthesis stem and the modular neck component. ► For easier handling, insert support handle 2 in the required position in one of the catches 4 on the turning handle. ► In order to loosen the implant connection, hold the extraction instrument 1 with one hand on the support handle 2 and turn in a clockwise direction with the other hand on the turning handle 3. The modular neck component will come loose. ► Remove the modular neck component. Note Hammer blows on the modular neck component, across the cone axis, will help loosening the cone connection. Avoid damaging the bone when doing this!

Disassembling ► Turn turning handle 3 clockwise until the stem 7 can be removed. ► Turn mounting wheel 5 anti-clockwise until the housing 6 and mounting wheel 5 come apart, see Fig. 2.

Assembling

► 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 Validated procedure

Specific requirements

Reference

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

■ 20 ml disposable syringe ■ Place the product in a tray that

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

is suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with their hinges open.

► Screw mounting wheel 5 clockwise onto the housing 6 as far as it will go. ► Insert stem 7 into housing 6 and tighten in an anti-clockwise direction using the turning handle 3, until the

standoff forks 8 have closed.

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for high-grade steel and titanium alloys according to manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 120 °C.

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Mechanical cleaning/disinfection with manual pre-cleaning

Validated reprocessing procedure

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).

General safety instructions

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

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 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.

Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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 ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

► For service and repairs, please contact your national B. Braun/Aesculap agency.

Mechanical alkaline cleaning and thermal disinfecting

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Disposal

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA

D–W: FD–W:

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

Packaging ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization Note The product may only be sterilized when dismantled. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

opening any valves and faucets). ► Validated sterilization process

– Disassemble the product – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.

Distributor in the US/Contact in Canada for product information and complaints

TA-Nr. 011426

03/13

V6

Änd.-Nr. 46824