activL – Revision instruments and distraction forceps

4 3

FW965R

FW960R

1

1

A

2

2

B 3

2

FW966R 5

C 1

3

FW967R

D 6

E

7

FW968R

FW998R

FW968R

4

F

8 FW965R

5

6 FW998R

FW579R

FW966R/ FW967R 9

7

10

8

12

10/11

9

9

12 10

14

8

10 15 6

11

13

11

en AESCULAP® activL® Revision instruments and distraction forceps Legend A activL angled distraction forceps FW960R B activL angled revision distraction forceps FW965R C activL revision instrument for endplates FW966R; size S/M D activL revision instrument for endplates FW967R; size L/XL E activL revision instrument for PE inlay FW968R F activL handle for revision instrument FW998R 1 Handle parts 2 Lock 3 Locking lever 4 Working tip 5 Pins 6 Jaw piece 7 Endplates 8 Adjustment knob 9 Anchoring rods 10 Hook 11 Recesses 12 Lock nut 13 Pins 14 Slots 15 Tubular shaft

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 activL revision instruments and distraction forceps. Note The applicable CE mark for the product can be seen on the label or packaging of the product. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. 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

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.

2.2.2

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.

2.3.1

Distracting/mobilizing vertebral bodies with the activL angled distraction forceps FW960R

DANGER Risk of fracture of the vertebral body endplates and/or injury to surrounding structures due to overdistraction! ► Apply proper care when distracting. ► Avoid excessive distraction. CAUTION Damage to the product caused by actuation of the locking lever! ► To release lock 2, gently press the handle parts 1 together and actuate locking lever 3. Note Mobilization of the intervertebral disk space is a critical process and should be performed under X-ray control. Note The intervertebral space distraction is often wedge-shaped. Sufficient load relief in the posterior intervertebral disk space is required so that parallel distraction can be performed over the entire intervertebral space. ► Insert the working end 4 into the intervertebral space, see Fig. 2. When doing so, ensure that the instrument is pushed as dorsally as possible into the intervertebral disk space. ► Distract/mobilize the distraction forceps FW960R by pressing the handle parts 1 together as required. Note Lock 2 engages automatically when handle parts 1 are released.

2.3.2

Removing the activL angled distraction forceps FW960R

► Gently press the handle parts 1 together and actuate locking lever 3, see Fig. 1.

This releases the lock 2 of the distraction forceps FW960R.

2.3.3

Applying the activL angled revision distraction forceps FW965R

DANGER Injury to surrounding blood vessels and soft tissue! Damage to the product or to the activL disk prosthesis! ► To protect the blood vessels, always use a retractor in conjunction with this product. ► Always insert the product into the two holes at the right-hand side of the prosthesis.

2.1

Areas of use and limitations of use

CAUTION Damage to the product caused by actuation of the locking lever! ► To release the lock, gently press the handle parts together and actuate locking lever 3.

2.1.1

Intended use

► Insert pins 5 of the distraction forceps FW965R into the holes on the right-hand side of the implant, see

The activL revision instruments and distraction forceps are used for the distraction/mobilization of two adjacent lumbar vertebral bodies or prostheses plates, as well as for the repositioning and revision of activL intervertebral disk prostheses. activL angled distraction forceps FW960R The activL angled distraction forceps is used for the distraction/mobilization of two adjacent vertebral bodies. activL angled revision distraction forceps FW965R The activL angled revision distraction forceps is used for distracting the two activL metal plates of an implanted activL prosthesis in order to remove the PE inlay in corrective surgery. activL revision instrument for endplates FW966R/FW967 and handle FW998R The activL revision instrument for endplates and the corresponding handle are used for the repositioning and revision of activL intervertebral disk prostheses.

Fig. 4. ► Distract the distraction forceps FW965R by pressing the handle parts 1 together as required.

Note Lock 2 engages automatically when handle parts 1 are released.

2.3.4

Removing the activL angled revision distraction forceps FW965R

► Gently press the handle parts 1 together and actuate locking lever 3, see Fig. 3.

This releases the lock 2 of the distraction forceps FW965R.

2.3.5

Removing the PE inlay with activL revision instrument for PE inlay FW968R from the intervertebral disk prosthesis

► Insert the jaw part 6 of the revision instrument FW968R between the two endplates 7 of the intervertebral

No known contraindications.

disk prosthesis, see Fig. 5. Ensure the following: – The orientation of the revision instrument FW968R in the caudal direction corresponds with the “caudal” marking on the revision instrument. – The edges of the jaw part 6 are pointing in the direction of the inferior endplates. ► Push the revision instrument along the lower endplate, until the jaw part 6 engages on the PE inlay. ► Turn the adjustment knob 8 clockwise to fix the PE inlay in place on jaw part 6, see Fig. 6. ► Lift the revision instrument FW968R with fixated PE inlay over the edge of the inferior endplate and remove from the endplate by pulling in the anterior direction. ► To remove the PE inlay from the revision instrument FW968R: – Rotate the adjustment knob 8 in a counterclockwise direction. – Pull the PE inlay from the jaw part 6.

2.2

2.3.6

activL revision instrument for PE inlay FW968R The activL revision instrument for PE inlay is used for the revision of the activL PE inlay.

2.1.2

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.

2.1.3

Contraindications

Safety information

Use of the activL revision instruments and distraction forceps requires precise knowledge about spine surgery and the stabilization and biomechanical situation at the spine. Surgical application of the activL revision instruments and distraction forceps is described in detail in the associated operating manual.

2.2.1

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.

Reposition/remove endplates with activL revision instrument for endplates FW966R/FW967R

DANGER Risk of injury to nerves and surrounding structures due to uncontrolled posterior pressure of the hooks of the anchoring rods! ► Apply proper care when manipulating the anchoring rods. ► Do not apply excessive pressure. ► Screw handle FW998R onto handpiece of revision instrument FW966R/FW967R, see Fig. 7.

Note The pins 13 on the screw connection of the anchoring rods of the revision instrument will point in the same direction as the corresponding hooks on the front part. Note In case of an incomplete revision of the implant, the endplates are removed one after another. The slotted hammer is also used for the revision procedure. Note The endplates can grow into and adhere strongly to the vertebral bodies. This can considerably complicate the revision procedure. If the revision is of a prosthesis implanted a number of years ago, the endplates may need to be removed from the intervertebral body with a chisel or elevator prior to using the revision instrument.

► Turn the anchoring rods 9 so that both hooks 10 are pointing outwards, see Fig. 8. ► Push the revision instrument FW966R/FW967R between the endplates. When doing so, ensure that the

hooks reach over the posterior edges of the plates. ► Turn both anchoring rods 9 90° in the direction of the plate to be removed. ► Pull back the anchoring rods 9. When doing so, ensure that the anchoring rods engage securely in the recesses 11 on the posterior side of the plate, see Fig. 9. ► Fix the anchoring rods 9 in place by turning the lock nut 12 counterclockwise. When doing so, hold the anchoring rods so that they cannot turn anymore. ► Carefully reposition or withdraw the plate. ► To remove the endplate completely, hit it out with the slotted hammer FW579R. ► Undo the lock nut 12 by turning it clockwise. ► Turn the anchoring rods 9 90° in the anterior direction and remove the endplate. ► If applicable, remove other endplates in the same way.

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 precleaning 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

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable

Chapter Manual cleaning/disinfection and subsection:

■ FW968R ■ FW998R

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

■ FW960R ■ Fw965R ■ FW966R ■ FW967R

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

■ FW968R ■ FW998R

for cleaning (avoid rinsing blind spots).

■ Keep working ends open for cleaning. ■ Place the product on the tray with all

■ Chapter Manual prealkaline cleaning and thermal disinfecting

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

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable

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

■ FW966R ■ FW967R

for cleaning (avoid rinsing blind spots).

■ Keep working ends open for cleaning. ■ Place the product on the tray with all

■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical

product links and joints open.

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

■ FW960R ■ Fw965R

Deviating manual pre-cleaning:

■ Phase I: Fully immerse the product in cold water for at least 5 min and mobilize nonrigid components at least two times. Ensure that all accessible surfaces are moistened.

■ Phase II: Clean the product with a suitable cleaning brush under running water until all discernible residues have been removed from the surface. Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

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

■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Phase III: 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. Mechanical cleaning

■ 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.

■ Keep working ends open for cleaning. ■ Place the product on the tray with all

Preparing for cleaning

FW966R, FW967R, FW968R: ► Disassemble the product prior to cleaning, see Disassembly.

► Unscrew handle FW998R of revision instrument FW966R/FW967R. ► Turn the anchoring rods 9 so that the hooks 10 are positioned in the direction of the slots 14. ► Slide the anchoring rods 9 behind the handpiece until the hooks 10 are positioned on the middle section

cleaning with a brush

■ Chapter Mechanical

product links and joints open.

► Open up product with hinges.

Disassembly

ing with ultrasound and immersion disinfection

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

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable

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.

activL revision instrument for endplates FW966R/FW967R

■ Chapter Manual clean-

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

Preparations at the place of use

3.6.1

Chapter Manual cleaning/disinfection and subsection:

ical compressed air

Reusable products

3.6

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable

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

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for

3.5

ing with immersion disinfection

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

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

■ Chapter Manual clean-

product links and joints open.

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

of the revision instrument FW966R/FW967R. When doing so, slide the hooks 10 through the slots 14, see Fig. 10. ► Turn the lock nuts 12 counterclockwise until they are fully undone. ► Slide the lock nuts 12 along the anchoring rods behind the handpiece.

3.8.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

3.6.2

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

-

-

-

-

activL revision instrument for PE inlay FW968R

► Turn the adjustment knob 8 counterclockwise and gently pull on the jaw part 6 until the jaw part comes

out, see Fig. 11.

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 are approved for, e.g., aluminum, plastics, and high-grade steel, according to the manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► 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 ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

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

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

3.9.1

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

-

disinfection 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.

3.8.2

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, phenolfree, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

RT

-

V

Drying

-

-

-

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

disinfection 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.

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

disinfection 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.

3.9.2

Manual pre-cleaning with ultrasound and brush

Phase

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

disinfection 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.

3.9.3

Mechanical alkaline cleaning and thermal disinfecting

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* 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

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.

D–W: FD–W:

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

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

3.9

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.

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

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

3.10.1 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. ► 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

Technical service.

3.10.2 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 properly (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.

3.11 Assembly 3.11.1 activL revision instrument for endplates FW966R/FW967R ► Slide the lock nuts 12 along the anchoring rods 9 as far as the threaded rods, see Fig. 10. ► Turn the lock nuts 12 clockwise onto the threaded rods. ► Turn the anchoring rods 9 so that the hooks 10 are positioned in the direction of the slots 14. ► Slide the hooks 10 through the slots 14.

3.11.2 activL revision instrument for PE inlay FW968R ► Insert the jaw part 6 into the tubular shaft 15 of the revision instrument FW968R until it engages, see

Fig. 11. When doing so, ensure that the “caudal” marking on the tubular shaft is aligned with the edge of the jaw part 6. ► Push the jaw part 6 in the direction of the adjustment knob 8 and turn the adjustment knob clockwise

until the jaw part is positioned just in front of the tubular shaft. When doing so, ensure that the jaw part is not compressed by the tubular shaft.

3.12 Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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 stor-

age.

3.13 Steam sterilization 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. ► 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.

3.14 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. TA011904

2022-02

Change No. AE0061406