S4 MIS Instruments

A FW734R

4

B

5

a

C 6

D

b 7

FW238R

c

50

60

70

80

40

50

60

70

80

3 d

50

4

40

20

1 FW272R

30

90

FW734R

100

H

10

0

I

80

70

60

50

a

5

40

F

f 2 c e

30 40

G

30

E

J

6

7 K

FW238R

en

Aesculap® S4® MIS Instruments Legend

1.

1 S4 MIS Taps FW714R, FW715R and FW716R 2 S4 MIS Guide instrument FW708R 3 S4 MIS Reduction lever Outer sleeve short FW705R 4 S 4 MIS Set screw long FW707R (for use with S4 Percutaneous thread pipe FW734R) 5 S4 MIS Spacer FW709R (for use with nut and guide sleeve of FW241R) 6 S4 MIS Rod insertion instrument, offset FW711R 7 S4 MIS Distraction arm short FW706R (for use with Distractor FW238R) 8 S4 MIS Tab Breaker FW712R

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

a Nut and guide sleeve of FW241R b Slider on the distraction arm c Reference point of the markings d Pedicle screw e Monoaxial pedicle screw f All-around marking

Figures A Disassembly threadpipe FW734R and Set screw FW707R B Disassembly spacer FW709R C Disassembly rod insertion instrument FW711R D Disassembly Distractor FW238R and Distraction arms short FW706R E Additional information regarding the marking on the outer sleeve F Additional information regarding the marking on the tap G Additional information regarding the marking on the guide instrument H Installation of threadpipe FW734R and Set screw FW707R I Installation of spacer FW709R J Installation of rod insertion instrument FW711R K Installation of Distractor FW238R and Distraction arms short FW706R

2

About this document

1.1

Scope

These instructions for use apply for the following products: Art. no.

Designation

FW705R

S4 MIS REDUCTION LEVER OUTER SLEEVE SHORT

FW706R

S4 MIS DISTRACTION ARM SMALL

FW707R

S4 MIS SETSCREW LONG F.FW734R

FW708R

S4 MIS GUIDE INSTRUMENT

FW709R

S4 MIS SPACER

FW711R

S4 MIS ROD INSERTION INSTRUMENT OFFSET

FW712R

S4 MIS TAB BREAKER

FW714R

S4 MIS TAP CANNULA SCR 4.5 MM

FW715R

S4 MIS TAP CANNULA SCR 5.5 MM

FW716R

S4 MIS TAP CANNULA SCR 6.5 MM

FW734R

S4 FRI REPOSITION LEVER THREADPIPE PERCUTANEOUS

Note The applicable CE mark for the product can be found on the label or packaging of the product. ► For article specific instructions for use and material

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

see

en 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 danger is not prevented, death or severe injuries can 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

2.1

Areas of use and limitations of use

2.1.1 Intended use The S4 MIS instruments complement the system scope of the S4 FRI - fracture reduction instruments. The S4 Instruments are used to implant the S4 implants of the systems listed below: ■ S4 Spinal System ■ S4 CS – Cannulated System ■ S4 FRI/S4 FRI Percutaneous The S4 MIS Instruments and S4 Fracture Reduction Instruments are used to reposition and stabilize fractures using the cannulated S4 Implants of the S4 Spinal System.

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 No known contraindications.

2.2

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. 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

Product specific safety information

► Read, comply with and retain instructions for use of

S4instruments TA012384 . ► Read, comply with and retain the operating manu-

als S4 Spinal SystemInstrumentation, S4 Modular Open Pedicle Screw System - Surgical technique O68002, S4 Modular MIS Pedicle Screw System Surgical technique O69002 and S4 MIS. ► To avoid damage to the working end: carefully insert the product through the working channel (e.g. trocar).

3

en 2.2.3 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

DANGER If the K-wire is pushed into the aorta, death may result! ► When inserting S4 implants or S4 instruments using the guide wire, observe the markings on the guide wire. ► Use forceps to hold the guide wire. ► Remove the guide wire in time. DANGER Danger of severe injuries from incorrectly positioning implants! The depth markings and scales on the instruments are indicative only! ► Observe the relevant reference points of the markings - see installation section. ► Check the correct position of the implants using x-ray. 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 Risk of injury due to excessive penetration of instruments or incorrect instrument selection! The markings and scales on the instruments are for reference only! ► X-ray checks when using invasive instruments. WARNING Risk of injury due to excessive penetration of the trocar insertion if the end stop is missing! ► Use trocar FW271M only in combination with K-wire aiming device FW258M.

4

WARNING The slipping of the outer sleeve FW705R may result in prolonged surgery! ► Secure the outer sleeve by hand when inserting/removing other instruments (e.g. tap, screwdriver). ■ The positioner FW708R can be used to refit the outer sleeve. ■ The outer sleeve can be secured via threadpipe FW234R and the Set screw long FW707R. CAUTION Using the wrong screwdriver can result in damage to or malpositioning of pedicle screws! ► Only use the guide instrument FW708R to screw in monoaxial pedicle screws. CAUTION If the screwdriver is not seated properly, damage to the monoaxial pedicle screw FW708R can result! ► When screwing in the monoaxial pedicle screw, always insert the screwdriver all the way into the head of the pedicle screw.

en 3.

Validated reprocessing procedure

3.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".

5

en 3.3

Reusable products

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

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably

with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Preparing for cleaning

► Do not disassemble anchoring screws/bolts that

permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly. ► Open products having hinges.

3.6

Disassembly

3.6.1 Threadpipe FW734R and set screw FW707R ► When using the set screw FW707R with the S4 per-

cutaneous thread tube FW734R: unscrew the set screw 4 from the threadpipe FW734R, see Fig. A.

3.6.2 Spacer FW709R ► Remove nut and guide sleeve a from spacer 5, see

Fig. B.

3.6.3 Rod insertion instrument FW711R ► Unscrew the inner part from the rod insertion

instrument6, see Fig. C.

3.6.4 Distractor FW238R and Distraction arms short FW706R ► Actuate the slider b and remove the distraction

arms 7 from the distractor FW238R, see Fig. D. ► Disassemble the distractor FW238R including the

distraction arms.

6

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! ► Use cleaning agents and disinfectants in accordance with the manufacturer's instructions, – which are approved for plastics and 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. ► 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. ► To prevent increased contamination of equipped instrument trays during use, please ensure that contaminated instruments are collected separately and not returned to the instrument tray.

en 3.7.2 Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush: TA011944,

Chapter Manual cleaning/disinfection and subsection: ■ Chapter Manual cleaning with immersion disinfection

TE654202

■ 20 ml disposable syringe ■ Keep working ends open for cleaning purposes.

■ Clean products having movable hinges in the open position or while moving the joints.

■ Drying phase: Use a lint-free cloth or medical compressed air Alkaline machine cleaning and thermal disinfection ■ FW705R

■ FW707R ■ FW709R ■ FW712R

■ Place product on a sterile screen basket suitable for 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.

Chapter Machine cleaning/disinfection and sub-sections: ■ Chapter Mechanical alkaline cleaning and thermal disinfection

■ Keep working ends open for cleaning purposes.

■ Open the links and joints before placing the product on the screen basket. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ■ FW706R

■ FW708R ■ FW711R ■ FW714R–FW716R ■ FW734R

■ Suitable cleaning brush: TA011944, TE654202

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

■ FW705R/FW709R/FW714R–FW716R: 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 pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Keep working ends open for cleaning purposes.

■ Open the links and joints before placing the product on the screen basket.

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 neces-

sary.

7

en 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

-

-

-

-

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.

8

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.

en 3.9

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.

3.9.1 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.

9

en 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

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. 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.

10

en 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

■ 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.

3.11 Inspection ► Allow the product to cool down to room tempera-

► Check the product for burrs that could damage tis-

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

► Check the product for loose or missing parts.

3.11.1 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 the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots.

sue or surgical gloves. ► Immediately put aside damaged or inoperative

products and send them to Aesculap Technical Service, see Technical service.

3.11.2 Functional test CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently oiled! ► Oil any moving parts (e.g. joints, sliding 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® Idrip-feed lubricator JG598).

11

en ► Assemble disassembled products, see Assembly.

3.13 Packaging

► Check that the product functions correctly.

► Place the product in its holder or on a suitable tray.

► 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 Note The scale on the outer sleeve 3 refers to the reference point c on the body of the pedicle screw d, see Fig. E. Note The scale on the taps 1 refers to the total length of the dilatation sleeve FW272R, see Fig. F. Note The scale on the guide instrument 2 refers to the reference point c on the body of the monoaxial pedicle screw e, see Fig. G. The all-round marker f serves as a guide when using the instrument as a guide instrument for repositioning the outer sleeve.

3.12.1 Threadpipe FW734R and set screw FW707R ► When using the set screw FW707R with the S4 Per-

cutaneous thread tube FW734R: screw the set screw 4 onto the threadpipe FW734R, see Fig. H.

3.12.2 Spacer FW709R ► Screw the nut of the spacer5 and the guide sleeve

and the nut of FW241Ra in the sequence shown onto the thread of the spacer 5, see Fig. I.

3.12.3 Rod insertion instrument FW711R ► Insert the inner part into the rod insertion

► Install Distractor FW238R, see TA012384.

12

tection against contamination of the product during storage. ► Secure products having ratchet locks fully opened or locked no further than the first notch.

3.14 Steam sterilization Note FW709R, FW711R, FW734R: Products can be sterilized in both the disassembled and the assembled state. Note To avoid failure due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first lock 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 – Disassemble the product – Steam sterilization in fractionated vacuum process – Steam sterilizer in accordance with EN 285 and validated in accordance with EN ISO 17665 – Sterilization in 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 protected from dust, in a dry, dark, temperaturecontrolled area.

3.12.4 Distractor FW238R and Distraction arms short FW706R the distraction arms 7 Distractor FW238R, see Fig. K.

process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient pro-

► Store sterile products in germ-proof packaging,

instrument 6 and tighten - see Fig.J.

► Attach

Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization

to

the

en 4.

Technical service

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

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

13