Distraction set with lockable distraction screws

2.3.2

en ®

Aesculap Distraction set with lockable distraction screws Legend 1 Distractor for lockable distraction screws, right 2 Distractor for lockable distraction screws, left 3 Screwdriver for lockable distraction screws 4 Lockable offset distraction screw 5 Hexagon 6 Shaft 7 Lockable distraction screw 8 Thumb screw 9 Ratchet lever 10 Toothed rack 11 Guide 12 Distraction arm (at guide) 13 Buttons (for locking and release) 14 Distraction arm (at toothed rack)

Sterility

Non-sterile packaged products Art. no.

Designation

FW848R

Distractor for lockable distraction screws, right

FW849R

Distractor for lockable distraction screws, left

FW850R

Distraction screwdriver for lockable distraction screws

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile products Art. no.

Designation

FW851SU

Lockable offset distraction screw, 12 mm

FW852SU

Lockable offset distraction screw, 14 mm

FW853SU

Lockable offset distraction screw, 16 mm

FW854SU

Lockable offset distraction screw, 18 mm

FW855SU

Lockable distraction screw, 16 mm

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

FW856SU

Lockable distraction screw, 18 mm

1.1

FW861SU

Lockable distraction screw, 12 mm

These instructions for use apply for the distraction set with lockable distraction screws. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

FW862SU

Lockable distraction screw, 14 mm

1.2

The product has been gamma-sterilized and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date.

1.

About this document

Scope

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: 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

Available sizes

Art. no.

Designation

FW848R

Distractor for lockable distraction screws, right

FW849R

Distractor for lockable distraction screws, left

FW850R

Distraction screwdriver for lockable distraction screws

FW851SU

Lockable offset distraction screw, 12 mm

FW852SU

Lockable offset distraction screw, 14 mm

FW853SU

Lockable offset distraction screw, 16 mm

FW854SU

Lockable offset distraction screw, 18 mm

FW855SU

Lockable distraction screw, 16 mm

FW856SU

Lockable distraction screw, 18 mm

FW861SU

Lockable distraction screw, 12 mm

FW862SU

Lockable distraction screw, 14 mm

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. In the text below, short designations are used for the following components: ■ Distractor for lockable distraction screws is referred to as "distractor" ■ Distraction screwdriver for lockable distraction screws is referred to as "distraction screwdriver" ■ Lockable distraction screws are referred to as "distraction screws" ■ Lockable offset distraction screws are referred to as “offset distraction screws” Note Any application of the distraction screw includes the application of the offset distraction screw, even if the latter is not mentioned explicitly!

2.4.1

Applying the distraction screw, see Fig. A

WARNING Compression of or damage to the spinal canal due to selection of a distraction screw of excessive length! ► Use the radiographic image to determine the correct length of the distraction screw according to the vertebral body. ► Always maintain x-ray control when applying the distraction screw. Note For very small vertebral bodies, offset distraction screws must be used to ensure that there is sufficient space for the implantation instruments! ► Choose distraction screw 7 or offset distraction screw 4. ► Insert distraction screw 7 or offset distraction screw 4 in distraction screwdriver 3. ► Place distraction screwdriver 3 on hexagon 5 of distraction screw 7 and make sure it engages. ► Check the self-holding function of distraction screw 7 in distraction screwdriver 3.

- or ► Place distraction screwdriver 3 on hexagon 5 of offset distraction screw 4 and make sure it engages.

2.2

Areas of use and limitations of use

2.4.2

2.2.1

Intended use

Note For very small vertebral bodies, offset distraction screws must be used to ensure that there is sufficient space for the implantation instruments!

The distractor for lockable distraction screws is used in combination with the corresponding lockable distraction screws for the parallel distraction of adjacent vertebral bodies in the cranial section for the purpose of extending the height of the intervertebral disk space.

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. 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.

Inserting the distraction screw into the vertebral body under X-ray control, see Fig. B

► Position and screw in distraction screw 7/offset distraction screw 4 at the center of the vertebral body. ► Remove distraction screwdriver 3 from distraction screw 7/offset distraction screw 4. ► Apply second distraction screw 7/offset distraction screw 4, ensuring that the distraction screw 7/offset distrac-

tion screw 4 is positioned in parallel.

2.4.3

Mounting the distractor and carrying out the distraction, see Fig. C/D

WARNING Risk of loosening/tear-out of the distraction screws when distracting with the distractor and the distraction screws! ► Use the distraction forceps for the distraction process. ► Do not use the distractor and the distraction screws for the actual distraction process. ► Lock the distractor in the extended condition. WARNING Irritation of the facet joints/strain on spinal cord and nerve roots due to excessive distraction! ► Extend the distraction forceps slowly and carefully under X-ray control. ► Observe the tactile response. ► Use the heights of adjacent (healthy) disks as a guide for the required degree of distraction. ► Select distractor right 1 or distractor left 2. ► Turn thumb screw 8 to transfer the distance of parallel distraction screws 4/7 to distraction arms 12/14.

The distance between distraction arms 12/14 corresponds to the distance between distraction screws 4/7. ► Mount distractor right 1 or distractor left 2 on parallel distraction screws 4/7 so that they click into position. ► Distract with the distraction forceps. ► While distracting with the distraction forceps, extend distractor right 1 or distractor left 2 by turning thumb

screw 8. ► Once the distraction process carried out with the distraction forceps is complete, lock distractor right 1 or dis-

tractor left 2 and hold the vertebrae in the distracted position.

2.4.4

Removing the distractor, see Fig. E

► To release the distraction after the implantation in the intervertebral disk space, press ratchet lever 9 at the dis-

tractor. Distraction arms 12/14 move toward each other. The distractor is fully released from any load. ► Press buttons 13 at the side of distraction arm 12/14 and slide off the distractor from distraction screws 4/7. ► Remove distraction screws 4/7 from the vertebrae, using distraction screwdriver 3.

3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method

3.

Validated reprocessing procedure

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 the material in question (e.g., aluminum, plastics, high-grade steel), – 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.

3.1

General safety instructions

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

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.

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

3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: 30 mm/∅: 5.5 mm,

Chapter Manual cleaning/disinfection and subsection:

■ FW848R–FW850R

■ Disposable syringe 20 ml ■ When cleaning instruments with

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.

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

Single-use products

or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ FW848R–FW850R

3.9

Manual cleaning/disinfection

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

3.9.1

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

-

Drying

RT

-

-

-

-

FW854SU

Lockable offset distraction screw, 18 mm

FW855SU

Lockable distraction screw, 16 mm

FW856SU

Lockable distraction screw, 18 mm

V

FW861SU

Lockable distraction screw, 12 mm

FW862SU

Lockable distraction screw, 14 mm

D–W: FD–W: RT: *Recommended:

Distractor for lockable distraction screws, right Distractor for lockable distraction screws, left

FW850R

Distraction screwdriver for lockable distraction screws

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.

3.5

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.

3.6

Preparing for cleaning

► Disassemble the product immediately after use, as described in the respective instructions for use. ► Disassemble the product prior to cleaning, see Disassembly.

3.7

Disassembly

► Pull distraction arm 12 (labeled "RIGHT/LEFT") along toothed rack 10 until toothed rack 10 is not seated in

guide 11 anymore.

cleaning and thermal disinfecting

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

Lockable offset distraction screw, 16 mm

FW849R

with a brush

■ Chapter Mechanical alkaline

all product links and joints open.

FW853SU

FW848R

■ Chapter Manual pre-cleaning

nozzle or flushing sleeve.

Lockable offset distraction screw, 14 mm

Designation

suitable for cleaning (avoid rinsing blind spots).

■ Place the product on the tray with

FW852SU

Reusable products

■ Disposable syringe 20 ml ■ Place the product on a tray that is

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

■ To flush the product: Use a flushing

Designation

Art. no.

e.g., TA006874

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

Lockable offset distraction screw, 12 mm

3.4

■ Cleaning brush: 30 mm/∅: 5.5 mm,

■ Connect components with lumens

FW851SU

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

immersion disinfection

■ Drying phase: Use a lint-free cloth

Art. no.

► Do not reuse the product.

■ Chapter Manual cleaning with

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

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.

e.g., TA006874

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature 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.

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

3.13 Packaging

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. ► 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.

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

3.14 Steam sterilization

3.10.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

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.

II

Rinsing

RT (cold)

1

-

D–W

-

► 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

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-

– 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

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.

3.10.2 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

D–W: 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

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 Tech-

nical service.

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 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.

3.12 Assembly Note Combine distraction arm 12 labeled "RIGHT" only with distraction arm 14 labeled "FW848R"! Combine distraction arm 12 labeled "LEFT" only with distraction arm 14 labeled "FW849R"! ► Push the ratchet lever 9. ► Mount distraction arm 12 (labeled "RIGHT/LEFT") with guide 11 on the toothed rack, ensuring the correct orien-

tation of the distraction arms 12/14.

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

trolled room.

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. TA012512

2020-05

V6

Change No. 62702