MACSTL insertion instrumentation for polyaxial screws

en ®

Aesculap MACSTL insertion instrumentation for polyaxial screws

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.

Legend

2.3.2

1 Hexagonal socket wrench 2 Catch 3 Hexagon insert bit 4 Ratchet grip 5 Reversing ring 6 Coupling ring 7 Cannulated screwdriver 8 Harris shaft 9 Catch 10 Hexagon insert bit 11 Handle 12 Insertion sleeve 13 Centralizer 14 MACSTL polyaxial clamping element 15 MACSTL polyaxial screw

Product-specific safety information Precise knowledge of vertebral body stabilization and its associated biomechanical principles are prerequisites for application of the MACSTL insertion instrumentation for the MACSTL polyaxial screw 15. Operative use of the MACSTL insertion instrumentation for MACSTL polyaxial screws 15 is described in detail in the relevant O.R. manual. ► Read the O.R. manual thoroughly before using the MACSTL insertion instrumentation for MACSTL polyaxial screws 15. ► Inform patients of the advantages and disadvantages of the MACSTL insertion instrumentation for MACSTL polyaxial screws.

1.

About this document

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

1.1

Scope

These instructions for use apply for MACSTL insertion instrumentation for polyaxial screws. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

2.3.3

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

Sterility

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

2.4

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. The reversing ring 5 on the ratchet grip 4 can be set in the following positions: ■ Middle position: Ratchet mechanism locked, left and right torque transmission ■ Left position (label FWD): Ratchet mechanism ready for use, right torque transmission ■ Right position (label REV): Ratchet ready for use, left torque transmission

2.4.1

Implantation

► Mount the insertion instrument with the centralizer 13. ► Prepare the opening in the vertebral body with preparation instruments and, if applicable, Kirsch-ner wire. ► Screw in the MACSTL polyaxial screw 15 with the ratchet grip 4 to a depth at which the MACSTL polyaxial clamp-

ing element 14 still has mobility on the vertebral body. At the same time, position and align the MACSTL polyaxial clamping element 14 with the aid of the handle 11.

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:

Product

Note After removal of the insertion instrument, the MACSTL polyaxial clamping element must still be fully mobile 14.

2.4.2

Releasing and removing the insertion instrument

► If a Kirschner wire was applied: Remove the Kirschner wire (see Instructions for use for the MACSTL Kirschner

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Scope of supply

wire instruments). ► Press down on the catch 9 and pull out the insertion instrument.

2.4.3

Removing the centralizer

► Mount the removal instrument. ► Check that the connecting implants (plate, rod) and locknuts have been emplaced. The fixation of connecting

implants/locknuts and the use of the MACSTL torque wrench are described in separate instructions for use.

Art. no.

Designation

► Be sure that the hexagon insert bit 3 of the removal instrument engages in the hexagonal socket of the

FW337R

Hexagonal socket wrench 1

► Loosen the centralizer 13 and screw it out of the MACSTL polyaxial clamping element 14. When doing this, exert

FW317R

Centralizer 13

FW400R*

Ratchet grip 4

FW319R

Cannulated screwdriver 7

FW316R

Handle 11

FW318R

Insertion sleeve 12

centralizer 13.

* FW400R is replaced by FW116R.

2.2

Areas of use and limitations of use

2.2.1

Intended use

The MACSTL insertion instrumentation is used for hand implantation of MACSTL polyaxial clamping elements and MACSTL polyaxial screws. The temporarily mounted centralizer serves the following purposes: ■ Providing axial support for the implantation of MACSTL polyaxial screws 15 ■ Positioning of MACSTL polyaxial clamping elements 14 ■ Emplacing connecting plates ■ Providing a point of impact for the force of distraction ■ Centering locknuts when affixing them ■ Transmitting a load moment when tightening locknuts The hexagonal socket wrench 1 (wrench diameter 5 mm) is used to mount the centralizer 13. For identification purposes, the instrument is equipped with a blue handle and is labeled “for centralizer”.

2.2.2

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.

2.2.3

Contraindications

No known contraindications.

2.3

Safety information

2.3.1

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.

counterforce on the handle 11. ► Press down on the catch 2 and remove the centralizer 13 from the removal instrument.

3.

Validated reprocessing procedure

3.1

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 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.ak-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 opportunity to recognize a product that 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

Preparing for cleaning

► Do not disassemble fixation screws which permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly. ► Disassemble the product prior to cleaning. ► Open up product with hinges. ► Remove the sealing cap from the Luer lock connector. ► Open all valves/faucets.

3.6

Disassembly

3.6.1

Removing the centralizer from the MACSTL polyaxial clamping element

Validated procedure

Specific requirements

Reference

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

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Place the product on a tray that

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

■ FW316R

with ultrasound and brush

■ Chapter Mechanical alkaline

■ Connect components with

cleaning and thermal disinfecting

lumens and channels directly to the rinsing port of the injector carriage.

■ To flush the product: Use a flushing nozzle or flushing sleeve.

■ Keep working ends open for

► Insert the hexagonal socket wrench 1 in the centralizer 13. ► Unscrew the centralizer 13 with the hexagonal socket wrench 1.

3.6.2

■ Chapter Manual pre-cleaning

is suitable for cleaning (avoid rinsing blind spots).

cleaning.

■ Place the product on the tray

Dismantling the insertion instrument

with all product links and joints open.

► Press down on the catch 9 of the cannulated screwdriver 7. ► Remove the cannulated screwdriver 7 from the insertion sleeve 12. ► Remove the handle 11 from the insertion sleeve 12. ► Pull the coupling ring 6 towards the stop, in the direction of the handle. ► Remove the cannulated screwdriver 7 from the ratchet grip 4.

3.8

3.6.3

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

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.

Dismantling the removal instrument

► Press down on the catch 2 of the hexagonal socket wrench 1. ► Remove the hexagonal socket wrench 1 from the insertion sleeve 12. ► Remove the handle 11 from the insertion sleeve.

3.7

Cleaning/Disinfection

3.7.1

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! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

3.8.1

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)

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

-

-

-

-

► 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

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

■ FW317R-FW319R ■ FW337R

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

■ Chapter Manual cleaning with immersion disinfection

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

infection procedure.

■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection

■ FW316R

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

cloth or medical compressed air

■ FW318R ■ FW337R

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

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

flushing nozzle or flushing sleeve.

■ Keep working ends open for

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

cleaning.

■ Place the product on the tray with all product links and joints open.

■ FW317R ■ FW319R

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

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.

■ To flush the product: Use a

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

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.

■ Drying phase: Use a lint-free Mechanical alkaline cleaning and thermal disinfection

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh

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

■ Chapter Manual pre-cleaning

3.8.2

Manual cleaning with ultrasound and immersion disinfection

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

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

-

-

-

-

with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ To flush the product: Use a flushing nozzle or flushing sleeve.

■ Keep working ends open for cleaning.

■ Place the product on the tray with all product links and joints open.

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-

3.10.2 Manual pre-cleaning with ultrasound and brush

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. 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

3.9

Mechanical cleaning/disinfection

Step

D [°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 fresh ► 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. 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.

3.10.3 Mechanical alkaline cleaning and thermal 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). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.9.1

Phase

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

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

■ working solution 0.5% – pH = 11*

– pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5%

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

– pH = 11* D–W: FD–W:

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

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

DW: FD–W:

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

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

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

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

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

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

3.10 Mechanical cleaning/disinfection with manual pre-cleaning 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.

3.10.1 Manual pre-cleaning with a brush 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

Rinsing

RT (cold)

1

-

D–W

-

► 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. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► 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: Drinking water 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.

3.11.2 Functional test CAUTION Damage (metal cold welding/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: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products, see Assembly. ► 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.

3.12 Assembly 3.12.1 Mounting the centralizer on the MACSTL polyaxial clamping element Precondition: The MACSTL polyaxial screw 15 and MACSTL polyaxial clamping element 14 have been mounted. ► Insert the hexagonal socket wrench 1 in the centralizer 13. ► Screw the centralizer 13 with the aid of the hexagonal socket wrench 1 onto the MACSTL polyaxial clamping element 14 in such a way that the pins engage in the grooves.

3.12.2 Mounting the insertion instrument The insertion instrument consists of: ■ a ratchet grip 4 ■ a cannulated screwdriver 7 ■ a handle 11 ■ an insertion sleeve 12 ► Pull the coupling ring 6 towards the stop, in the direction of the handle. ► Insert the cannulated screwdriver 7 in the ratchet grip 4. ► Release the coupling ring 6. ► Put the handle 11 all the way onto the insertion sleeve 12. ► Push the cannulated screwdriver 7 through the insertion sleeve 12 all the way to the stop.

3.12.3 Mounting the removal instrument The removal instrument consists of: ■ a hexagonal socket wrench 1 ■ a handle 11 ■ an insertion sleeve 12 ► Put the handle 11 all the way on the insertion sleeve 12. ► Push the hexagonal socket wrench 1 through the insertion sleeve 12 all the way to the stop.

3.12.4 Mounting the centralizer on the insertion/removal instrument Precondition: ■ Either the insertion or removal instrument is mounted ■ The centralizer 13 is mounted on the MACSTL polyaxial clamping element 14. ► Push the centralizer 13 on the insertion sleeve 12 until it engages, and at the same time hold onto the MACSTL polyaxial clamping element 14. The two components are now interlocked.

3.13 Packaging ► Appropriately protect products with fine working tips. ► 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.

3.14 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Note The product may only be sterilized in disassembled condition. ► 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 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.

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

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► 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. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA010385

2020-09

V6

Change No. 63349