Multipiece instruments with roller closing mechanism

► 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.

®

Aesculap Multipiece instruments with roller closing mechanism Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

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 Product-specific safety notes on the reprocessing procedure

About this document Note General risk factors associated with surgical procedures are not described in this documentation.

CAUTION

Scope Multipiece instrument with roller closing mechanism and screw and/or: ■ with flat or coil spring ■ with third valve ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet at www.extranet.bbraun.com

Intended use

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Keep working ends open for

Chapter Manual cleaning/disinfection and sub-chapter:

This instrument is used in universal surgical application in all fields.

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

See intended use

No known absolute contraindications.

Mechanical alkaline cleaning and thermal disinfection

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

■ All except FW023R

Safe handling and preparation

Validated reprocessing procedure

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

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. 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.

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the instrument in a tray

■ FW023R

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

■ Place the product on the tray

cleaning and thermal disinfecting Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

with all product links and joints open.

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

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

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

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

■ Chapter Mechanical alkaline

with their hinges open.

► 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.

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Place instruments in the tray

Relative contraindications The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the operation. In the presence of relative contraindications, the user decides individually regarding the use of the product.

immersion disinfection

cleaning.

Indications

Absolute contraindications

■ Chapter Manual cleaning with

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

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.

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. 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. ► Drain any remaining water fully.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

Mechanical alkaline cleaning and thermal disinfecting Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

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

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

Mechanical cleaning/disinfecting

IV

Thermal disinfecting

90/194

5

FD-W

-

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).

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

D–W: FD–W:

Mechanical alkaline cleaning and thermal disinfecting

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

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

Inspection, maintenance and checks

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

CAUTION

– pH = 11*

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 instrument is dry, clean, operational,

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

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).

D–W: FD–W:

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

► 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. ► Check for compatibility with associated products.

Packaging

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

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).

► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► Close the locks so that the jaw tips just touch each other. ► 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 sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

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

Steam sterilization

Manual pre-cleaning with a brush

Note The product can be sterilized either in disassembled or in assembled condition.

Mechanical cleaning/disinfection with manual pre-cleaning

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth.

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

Rinsing

RT (cold)

II

opening any valves and faucets). ► Validated sterilization process

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

– Steam sterilization using 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 instruments 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.

Storage ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

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

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. 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.

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. 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] Other service addresses can be obtained from the address indicated above.

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

TA016757

2018-12

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