S4 instruments

en

Aesculap® S4® instruments Legend

1.

1 2 3 4

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

Set screw starter FW177R Counter-torque with L-handle FW178R Rod persuader FW208R Reduction lever (consisting of inner tube FW229R, screwdriver FW228R and outer sleeve FW235R and spacer FW141P or FW143P) 5 Reduction lever percutaneous (consisting of inner tube FW229R, screwdriver FW228R and outer sleeve FW353R and spacer FW141P or FW143P) 6 Counter torque FW236R 7 Nut wrench FW237R 8 Distractor (consisting of distractor FW238R and two distractor arms FW239R) 9 Rod insertion instrument FW240R 10 Distraction spindle FW241R (consisting of distractor and extension) 11 Rod length measuring instrument FW242R 12 Screw length measuring instrument FW351R 13 Slotted hammer FW243R 14 Tissue protection tube FW244P 15 Tissue protection tube FW355P 16 K-wire FW247S 17 Trocar FW271M 18 K-wire aiming device FW258M 19 Handle for removing K-wire aiming device FW274M 20 K-wire protection sleeve FW352R 21 Cannulated monoaxial screwdriver FW262R 22 Pedicle dissector FW263R 23 Screw tabs FW264R, FW265R, FW266R, FW267R and FW268R 24 Polyaxial screwdriver FW270R 25 Dilation sleeve FW272R 26 Dilation sleeve FW354R 27 Screwdriver FW176R

2

About this document

1.1

Scope

► For article specific instructions for use and material

compatibility and lifetime information, B. Braun eIFU at eifu.bbraun.com

see

Note The applicable CE mark for the product can be found on the label or packaging of the product.

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 potential danger. If it is not prevented, death or severe injuries 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.

en 2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1 Intended use The S4 instruments are used to implant the S4 implants using the systems listed below: ■ S4 Spinal System ■ S4 CS - Cannulated System ■ S4 FRI/S4 FRI percutaneous The S4 fracture reduction tools are used to reposition and stabilize fractures using the cannulated S 4 implants of the S4 Spinal system.

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

Product specific safety information

► To avoid damage to the working end: Carefully

No known contraindications.

insert the product through the working channel (e.g. trocar). ► Read and observe the OP manuals listed below and keep them in a safe place: – S4 Modular Open Pedicle Screw System - Surgical Technique O68002 – S4 Element MIS Surgical Technique O69002 – S4 Element Surgical Technique O74002 – S4 Element MIS Surgical Technique O82002 – S4 Long Tab Surgical Technique O82302

2.2

2.2.3

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

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.

Sterility

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

Name

FW247S

S4 KIRSCHNER DRILL WIRE 1.5 X 440MM BLUNT

► Do not reuse product. Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not process product.

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.

3

en 2.3

Application

DANGER If the guidewire is pushed into the aorta this can be life-threatening for patients! ► When inserting S4 implants or S4 instruments using the guidewire, observe the markings on the guidewire. ► Use forceps to hold the guidewire. ► Remove the guidewire in time. 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. WARNING Any excessive instrument penetration or incorrect instrument selection can result in injury to the patient! The markings and scales on the instruments are for guidance only! ► X-ray checks when using invasive instruments. WARNING The trocar might be inserted too far in case of a missing end stop! ► Use trocar FW271M only in combination with K-wire aiming device FW258M. ► Only use the products under visual control. WARNING Pedicle screw insufficiently anchored in pedicle! ► If pedicle screws having the diameters ∅ 4 or ∅ 4.5 mm are to be used, do not dissect the pedicle using FW263R or SZ376R . Note UseFW274M to remove FW258M.

4

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.

en 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

Single use products

Art. no.

Designation

FW247S

S4 KIRSCHNER DRILL WIRE 1.5 X 440MM BLUNT

► Do not reuse product. Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not process product.

3.4

Reusable products

Note The information listed below applies to all products not intended for single use. 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.

3.5

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

► Do not disassemble anchoring screws/bolts that

permanently connect the various components. ► Disassemble the product prior to cleaning, see Dis-

assembly.

3.7

Disassembly

► Disassemble the set screw starter using an open-

ended SW6 wrench, see Fig. 1.

Fig. 1 Note The locking screw insert does not need to be disassembled for cleaning purposes.

5

en ► Disassemble reduction lever 4, see Fig. 2. Fully dis-

assemble reduction lever and unbolt lock nut.

► Disassemble rod insertion instrument 9, see Fig. 5:

Unscrew the inner part.

Fig. 2 Fig. 5 ► Disassemble reduction lever percutaneously 5, see

Fig. 3. Fully disassemble reduction lever and remove lock nut.

► Disassemble distraction spindle 10, see Fig. 6.

Fig. 6

5 Fig. 3

► Disassemble rod length measuring instrument 11,

see Fig. 7.

► Disassemble distractor 8 including the distractor

arms, see Fig. 4: Actuate slider B and remove distractor arm FW239R.

Fig. 4 Legend B Slider

Fig. 7

6

en 3.8

Cleaning/Disinfection

3.8.1 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! ► Use cleaning agents and disinfectants in accor► For wet disposal use suitable cleaning agents/disindance with the manufacturers' instructions. fectants. To prevent foam from forming and a reduced effectiveness of the process chemicals: ► Observe specifications regarding concentration, Prior to mechanical cleaning and disinfection, rinse temperature and exposure time. the product thoroughly under running water ► Do not exceed the maximum allowable disinfection ► If the microsurgical products can be secured in temperature of 95 °C. machines or storage racks suitable for thorough ► To prevent increased contamination of equipped cleaning, have the microsurgical products mechaninstrument trays during use, please ensure that ically cleaned and disinfected. contaminated instruments are collected separately and not returned to the instrument tray.

3.8.2 Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Manual cleaning with immersion disinfection only: FW141P, FW143P, FW177R FW178R, FW228R, FW229R, FW235R, FW236R– FW239R, FW241R– FW243R, FW244P, FW247S, FW258M, FW262R–FW268R, FW270R, FW271M, FW272R, FW274M, FW351R–FW354R, FW355P

■ Cleaning brush: TA011994/TE654202, GK469200 Chapter Manual cleaning/disinfection and sub■ Single use syringe 20ml sections: ■ Keep working ends open for cleaning purposes. ■ Chapter Manual clean■ Clean products having movable hinges in the open ing with immersion dis-

Manual cleaning using ultrasound and immersion disinfection only: FW176R, FW208R, FW240R

■ Cleaning brush: TA011994/TE654202, GK469200 Chapter Manual cleaning/disinfection and subsec■ Single use syringe 20ml tion: ■ Keep working ends open for cleaning purposes. ■ Chapter Manual clean■ Clean products having movable hinges in the open ing with ultrasound and

position or while moving the joints.

Reference

infection

■ Drying phase: Use lint free cloth or medical compressed air

■ Check visible surfaces for residue after manual cleaning/disinfection.

■ Repeat the cleaning process if necessary.

position or while moving the joints.

immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air

7

en Validated procedure

Specific requirements

Reference

Alkaline machine cleaning and thermal disinfection only: FW141P, FW236R, FW237R, FW241R, FW243R, FW244P, FW247S, FW274M, FW258M, FW272M, FW353R, FW354R, FW355P

■ Place the product on a tray that is suitable for

Chapter Machine cleaning/disinfection and subsections: ■ Chapter Mechanical alkaline cleaning and thermal disinfection

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection only: FW143P, FW177R, FW178R, FW208R, FW228R, FW229R, FW235R, FW238R, FW239R, FW240R– FW242R, FW262R– FW268R, FW270R, FW271M, FW351R, FW352R

■ 20 ml disposable syringe ■ Place product on screen basket suitable for clean-

Manual pre-cleaning using ultra-sound and brush and subsequent alkaline machine cleaning and thermal disinfection only: FW208R

■ 20 ml disposable syringe ■ Put jaw protecting cap on the product. ■ Place product on a screen basket suitable for

cleaning (avoid rinsing blind spots).

■ Connect the lumens and channels of individual parts directly to the injector unit's special flushing connector.

■ Keep working ends open for cleaning purposes. ■ Open the links and joints before placing the product on the screen basket.

ing (make sure all areas will be reached by water jets).

■ FW178R, FW228R, FW235R, FW258M, FW262RFW268R, FW270R, FW352R, FW272R, FW354R: Connect the lumens and channels of individual parts directly to the injector unit's special flushing connector.

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection: ■ Chapter Manual precleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Keep working tips open for cleaning purposes. ■ Open the links and joints before placing the product on the screen basket.

cleaning (make sure all areas will be reached by water jets).

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

■ Keep working tips open for cleaning purposes. ■ Open the links and joints before placing the prod-

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsections: ■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

uct on the screen basket.

3.9

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.

8

► Repeat the cleaning/disinfection process if neces-

sary.

en 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

-

V

Drying

RT

-

-

-

-

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 ► Fully immerse the product in the cleaning/disinfec-

tant 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.

9

en 3.9.2 Manual cleaning with ultrasound and immersion disinfection 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

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

-

-

-

-

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.

10

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.

en 3.10 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.

3.10.1 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – 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

DW: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical

cleaning/disinfecting.

11

en 3.11 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.

3.11.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant 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 ► Fully immerse the product in the cleaning/disinfec-

tant 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.

12

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.

en 3.11.2 Manual pre-cleaning with ultrasound and brush 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

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

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.

(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.

13

en 3.11.3 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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

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.

14

en 3.12 Inspection

► Check for compatibility with associated products.

► Allow the product to cool down to room tempera-

► Immediately put aside inoperative products and

ture. ► Dry the product if it is wet or damp.

3.12.1 Visual inspection ► Ensure that all soiling has been removed. In partic-

ular, 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 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 Technical service.

3.12.2 Functional test CAUTION The product may become damaged (metal pitting/fretting corrosion) if insufficiently oiled! ► Oil any moving parts (e.g.joints, spool parts and threaded rods) prior to the functional test using oil suitable for the applied sterilization process (e.g. STERILIT® I oil spray JG600 for steam sterilization or STERILIT® I drip-feed lubricator JG598). ► Assemble disassembled products, see Assembly.

send them to Aesculap Technical Service, see Technical service.

3.13 Assembly 3.13.1 Assemble the set screw starter ► Hand-tighten the bolt(s) of the set screw starter,

see Fig. 8.

Fig. 8 Note The set screw starter is not designed to remove set screws. If the working end comes loose, it can be tightened by hand without any tools. Use the set screw revision screwdriver FW193R to remove the set screws.

3.13.2 Assemble the reduction lever ► Assemble reduction lever 4, see Fig. 9.

Fig. 9

3.13.3 Assemble reduction lever percutaneous ► Screw lock nut C onto inner sleeve, see Fig. 10.

C

Fig. 10 Legend C Clamping nut

► Check that the product functions correctly. ► Check that all moving parts are working property

(e.g. hinges, locks/latches, sliding parts etc.). ► Check rotating products (e.g.reusable drills and

cutters) for bends and deformities. To do this, roll the product, for example, on a flat surface.

15

en ► Insert the screwdriver in the inner sleeve, use the

► Assemble distraction spindle 10, see Fig. 15.

spacer to secure it and attach the set screw D, see Fig. 11.

D

Fig. 11

Fig. 15

► Insert the subassembly into the FRI outer sleeve,

► Assemble rod length measuring instrument 11, see

see Fig. 12.

Fig. 16.

Fig. 12

3.13.4 Assemble further components of the device ► Assemble distractor 8 including its distractor arms,

see Fig. 13.

Fig. 13 ► Assemble rod insertion instrument 9, see Fig. 14.

Fig. 16 Fig. 14

16

en 3.14 Packaging

4.

Technical service

► Appropriately protect products with fine working

tips. ► Secure products having ratchet locks fully opened

or locked no further than in the first notch. ► Close the locks until the jaw tips are just in contact. ► 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 pro-

tection against contamination of the product during storage.

3.15 Steam sterilization Note FW240R, FW270R: The product may only be sterilized in a disassembled state. Note FW177R, FW208R, FW238R, FW239R, FW240R, FW242R, FW262R–FW268R, FW272R: The product can be sterilized in both a disassembled and an assembled state.

CAUTION Modifications to 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.

4.1

Art. no.

Name

FW233201

Replacement nut (for distractor FW238R and distraction spindle FW241R)

► 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 in a fractionated vacuum process – Steam sterilizer in accordance with DIN EN 285 and validated in accordance with DIN EN ISO 17665 – Sterilization in a 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.

Accessories/spare parts

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.

3.16 Storage ► Store sterile products in germ-proof packaging,

protected from dust, in a dry, dark, temperaturecontrolled area.

17