S4 percutaneous instruments

en ®

Aesculap S4® percutaneous instruments Legend 1 Cleaning instrument FW692R 2 Clamp sleeve FW693R 3 Percutaneous outer sleeve FW735R 4 Inner sleeve FW694R 5 Inner sleeve FW734R 6 Screwdriver FW695R (for polyaxial S4 bolts) 7 Screwdriver FW696R (for monoaxial S4 bolts) 8 Spacer axial FW143P 9 Insertion instrument for locking screws FW697R 10 Counterholder for percutaneous outer sleeve FW736R

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.

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

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.

1.1

2.2.2

1.

About this document

Scope

These instructions for use apply for the following products:

Product specific safety information

► Read, observe and safely store the OR Manuals S4 Spinal System Instrumentation, S4 Modular MIS Pedicle Screw

System - Surgical technique O69002. Art. no.

Designation

FW692R

Cleaning instrument

FW693R

Clamp sleeve

FW735R

Percutaneous outer sleeve

FW694R

Inner sleeve

FW734R

Inner sleeve

FW695R

Screwdriver for polyaxial S4 bolts

FW696R

Screwdriver for monoaxial S4 bolts

FW143P

Spacer axial

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.

FW697R

Insertion instrument for set screws

2.3.1

Counterholder for percutaneous outer sleeve

The cleaning instrument is used to clean/clear the cannulation if a cannulated instrument is blocked intra-operatively by soft tissue or bone chips.

FW736R

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, see B. Braun eIFU 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 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.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

S4 percutaneous instruments are used to implant cannulated S4 implants of the S4 Spinal System using a percutaneous operating technique.

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.

2.2.3

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 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.

Cleaning instrument FW692R

WARNING Risk of injury if the cleaning instrument punctures the cannulated instrument! ► Carefully remove the obstruction by applying a slight pressure. ► Always insert the cleaning instrument in the direction of the working end. ► Do not use your hand to close the outlet port. CAUTION Incorrect use of the cleaning instrument may damage cannulated instruments! ► Always insert the cleaning instrument in the direction of the working end. ► Check the cleaning instrument for bends, kinks and other damage before use. ► Disassemble the instrument where possible on a separate sterile table, if applicable see Disassembly ► Carefully insert the cleaning instrument into the cannulation from the handle side towards the working end. ► Remove the obstruction by using the handle part to apply slight pressure. Be careful not to obstruct the cannu-

lation. ► Install the instrument.

2.3.2

Clamp sleeve FW693R and screwdriver FW695R/FW696R

Screwdrivers facilitate the percutaneous application of pedicle screws of the S4 Spinal System. Depending on the type of bolt, the corresponding screwdriver for monoaxial or polyaxial bolts must be chosen. ► Assemble the clamp sleeve, see Assembly. Insert the pedicle screws in the clamp sleeve ► Turn clamping bolt C in the direction of the arrow until the thread in the direction of the working end becomes visible, see Fig. 1. ► Pull the outer sleeve A back as far as possible towards the clamping bolt C, see Fig. 2. ► Insert screwdriver F into clamp sleeve 2 from the rear end. Make sure the side lugs slide into the grooves all the way to the bottom, see Fig. 3. ► Insert the working ends of the pedicle screws into the tension sleeve B, see Fig. 4. For polyaxial pedicle screws: Ensure that the hexagon of the screwdriver is fully inserted in the hexagon of the polyaxial pedicle bolt. For monoaxial pedicle bolts: Ensure the dihedron is seated securely in the bolt head. ► Push the outer sleeve A towards the pedicle bolt and clamp it into the clamp sleeve 2 using the clamping bolt C, see Fig. 5. ► Check to ensure that the implant is properly seated in the clamp sleeve 2. ► For implanting the pedicle screw and inserting the rod, see operating technique or operating manual for the S4 Spinal System, S4 FRI and S4 SRI. Remove the clamp sleeve from the inserted pedicle screw ► Turn clamping bolt C in the direction of the arrow until the thread in the direction of the working end becomes visible, see Fig. 6. ► Pull back the outer sleeve A towards the clamping bolt C. ► Remove Complete clamp sleeve 2, see Fig. 7.

3.

Validated reprocessing procedure

3.7.2

3.1

General safety information

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: e.g. TA007747 and/or TE654202 ■ Disposable syringe 20ml ■ Keep working ends open for cleaning purposes. ■ Clean products having movable hinges in the open

Chapter Manual cleaning/disinfection and subsection:

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

Validated cleaning and disinfection procedure

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.

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

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.

Alkaline machine cleaning and thermal disinfection

Note If there is no final sterilization, then a virucidal disinfectant must be used.

■ Spacer FW143P ■ Cleaning instru-

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

3.4

ment FW692R

■ Clamp sleeve

■ 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.

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.

Chapter Machine cleaning/disinfection and subsections:

■ 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.

FW693R

■ Insertion instrument for set screws FW697R

■ Percutaneous outer sleeve FW735R

■ Counterholder for percutaneous outer sleeve FW736R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Inner sleeve FW694R and FW734R

■ Screwdriver FW695R and FW696R

■ Cleaning brush: e.g. TA007747 and/or TE654202 ■ Disposable syringe 20ml ■ Place product on a sterile screen basket suitable for

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

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

■ Chapter Manual pre-

■ Connect the lumens and channels of individual parts

■ Chapter Mechanical

directly to the injector unit's special flushing connector.

cleaning with a brush

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

alkaline cleaning and thermal disinfecting

on the screen basket.

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.

ing with immersion disinfection

position or while moving the joints.

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

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.

■ Chapter Manual clean-

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 dis-

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

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*

► Pull the outer sleeve A off over the collet B towards the working end. ► Unscrew clamping bolt C towards the rear end and remove from collet B, see Fig. 8.

II

Intermediate rinse

RT (cold)

1

-

D–W

-

3.6.2

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

-

-

-

-

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.

3.6

Disassembly

3.6.1

Clamp sleeve FW693R

Inner sleeve FW694R and FW734R

► Unscrew nut D from inner sleeve E, see Fig. 9.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

Hazardous to patients! The product may not be processed manually. ► Process the product exclusively by machine. ► Process the product only by mechanical cleaning preceded by manual pre-cleaning. Mechanical cleaning/disinfection may cause damage to or destruction of the product! ► Only clean/disinfect the product manually. ► Do not sterilize the product under any circumstances. Unsuitable cleaning/disinfecting agents may cause damage to or destruction of the product! ► Only use cleaning/disinfecting agents approved for surface cleaning in accordance with the manufacturer’s instructions. 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. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

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.

3.9

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

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

3.10.2 Mechanical alkaline cleaning and thermal disinfecting 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%

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Pre-rinse

<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

– pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: 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.

3.11 Inspection

D–W: FD–W:

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

► 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 visible surfaces for residues after mechanical cleaning/disinfecting.

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

► Check the product for missing or faded labels. ► Check products having long, narrow geometries (in particular rotating instruments) for deformations. ► 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

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 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.

CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently 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. ► 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 product, for

example, on a flat surface. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.12 Assembly 3.12.1 Clamp sleeve FW693R ► Screw the clamping bolt C onto the collet B until the thread of the collet is just covered. ► Slide outer sleeve A over the collet B from the front, see Fig. 10. Make sure the slots are aligned with the T-nuts.

The ribbed end of the clamp sleeve should point towards the clamping bolt C for ease of use.

3.12.2 Inner sleeve FW694R and FW734R ► Bolt nut D onto inner sleeve E, see Fig. 11.

3.13 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.14 Steam sterilization Note The product may only be sterilized in a disassembled state. ► 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 EN285 and validated in accordance with EN ISO17665 – Sterilization in the fractionated vacuum process at 134 °C, holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Technical service

CAUTION Modifications 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.

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. TA013496

2020-12

V6

Change No. 63662