Torque wrench 20 Nm 27 Nm

en Aesculap® Torque wrench 20 Nm / 27 Nm 1.

About this document

WARNING Implant failure owing to incorrect assembly of the tibial shafts! ► Screw the threaded end of the tibial shaft into the nut of the tibial shaft attachment. ► Adjust the ML position of the tibial shaft in a way that the asymmetric support collar is oriented so that the side extending further is oriented towards the neutral 0 position. ► Tighten the tibial shaft by hand. ► Only use a torque wrench for the final tightening.

Note General risk factors associated with surgical procedures are not described in these instructions for use.

► When tightening the tibial shafts, use the adapters NE185R (12 mm and 14 mm shaft diameter) or NS835R

1.1

► Torque the tibial shaft to 20Nm.

Scope

These instructions for use apply to the products listed below: Torque wrench 20 Nm / 27 Nm ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows:

(10 mm shaft diameter) and counterhold them on the tibia using a tibia counterholder suiting the system. WARNING Incorrect securing of the tibial locking ring can result in implant failure! ► Insert the rotation axle and its bearing sleeve in the tibial component and use the tibial locking ring to secure it. To do so, first turn the locking ring by hand. ► Only use a torque wrench for the final tightening. ► When tightening the tibial locking ring, use the wrench NP454R (for meniscus components size F1, H 10 mm and

H 12 mm: locking ring spanner NP462RM) and counterhold using the tibial plateau holder NQ830R. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

Intended use The NE184RM torque wrench is used for the controlled tightening of bolted modular connections in Aesculap knee systems: ■ for tightening the tibial and femoral extension stems using the adapters NE185R and NS835R. ■ at the EnduRo knee system for tightening the tibial locking ring using the wrenches NP454R (for meniscus component NP462R: size F1, H=10mm and H=12mm) ■ at the EnduRo knee system for pre-tensioning the cone connection between the rotation axle and the hinge ring using the adapter NP420R ■ at the EnduRo knee system for tightening the lock nut on the rotation axle using the insertion instrument NP455R The NE184RM torque wrench has a 3/8" square connection fitting. All associated adapters and wrenches fit into this connection fitting.

Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

Contraindications No known contraindications.

2.2

Safety information

Clinical user General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

Sterility The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. ► Tighten screws using even, clockwise turns of the torque wrench. ► Adjust the torque until the indicator points at the specified value (20 Nm or 27 Nm).

WARNING Incorrect mounting of the femoral stems can result in implant failure! ► When inserting the femoral shaft including the pre-assembled tension bolt and nut into the dovetail of the femoral implant, make sure that the side lugs on the femoral shaft engage in the groove of the intercondylar box on the femoral component. ► Properly adjust the A-P position of the femoral shaft. ► Use the adapter NE185R to tighten the tension bolt by hand. ► Only use a torque wrench for the final tightening. ► When tightening the femoral joints, use the adapter NE185R and counterhold using the shaft holder that

matches the shaft type. ► Use a shaft holding instrument for counterholding when tightening the femoral shafts. Make sure that the coun-

terholder is positioned in the section grooves of the shaft as close to the torque wrench as possible. ► Torque the femoral shaft to 27 Nm.

► Torque the tibial locking ring to 27Nm.

WARNING Incorrect coupling and securing of the cone connection between the rotation axle and the femoral hinge ring can result in implant failure! ► Once the femoral and tibial components have been implanted, and the meniscal component has been inserted, fit the cone connection between the rotation axle and the femoral hinge ring. ► Only use a torque wrench for the final tightening. ► Swing the hinge ring over the rotational axle. ► Attach the adapter NP420R coupled to the counterholder NP419R to the threads of the rotation axle and tighten

by hand. ► Use the counterholder NP419R when tightening the cone connection. ► Torque cone connection to 20 Nm. ► Remove the NP420R adapter and the counterholder NP419R. ► Place the lock nut in the insertion instrument NP455R and use the locking ring to secure it. ► Tighten the lock nut by hand. Loosen the locking ring as soon as the lock nut is bolted on the thread and cannot

become drop off anymore. ► During the final tightening, secure the implant holder NQ570R including a suitable femoral insert and attached

handle NP495R on the implant and counterhold. ► Torque lock nut to 20 Nm.

3.

Validated reprocessing procedure

3.1

General safety information

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. 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 B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection.

3.4

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.

3.5

Cleaning/Disinfection

Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound

Product-specific safety information on the reprocessing method Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants in accordance with the manufacturer's instructions, – which are approved for aluminum, plastics and high-grade steel. – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

■ 0.5 % working solution – pH = 11*

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free

Reference

III

Intermediate rinse

>10/50

1

FD-W

-

Chapter Manual cleaning/disinfection and subsection:

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

■ Chapter Manual cleaning with immersion disinfection

cloth or medical compressed air

■ Place the product on a tray that

Alkaline machine cleaning and thermal disinfection

is suitable for cleaning (avoid rinsing blind spots).

Chapter Machine cleaning/disinfection and sub-sections:

■ Chapter Mechanical alkaline cleaning and thermal disinfection

3.6

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

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

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

Visual inspection ► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps.

Manual cleaning with immersion disinfection Step

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

3.8

Manual cleaning/disinfection

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

Phase

D–W: FD–W:

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components.

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)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

► Check the product for missing or faded labels. ► Check products having long, narrow geometries (in particular rotating instruments) for deformations. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► 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. 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. 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. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.7

Machine cleaning/disinfection

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.

Functional test ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.9

Packaging

► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.10 Steam sterilization ► 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

– Steam sterilization using fractional 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 ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Technical service

CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA012951

2020-04

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Change No. 62628