S4 Spondylolisthesis Reduction Instrument (SRI) FW225R

FW232R 5

FW 231R 4

3

2

1

FG322R

9 10

FG321R

11

12

8

6 7

en

AESCULAP® S4®Spondylolisthesis Reduction Instrument (SRI) FW225R Legend

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

1 Cylinder piece 2 Polyaxial screw body 3 Fitting 4 Outer T-handle 5 Inner T-handle 6 Distraction spindle 7 Articulated head of the fitting 8 Distraction spindle nut 9 Chuck key 10 Reduction lever 11 Adjusting screw 12 Rod

1.

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

About this document

2.

Clinical use

2.1

Components required for usage

Art. no.

Designation

FG321R

SOCON Chuck key for spindle distractor

FG322R

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

SOCON Quick-release chuck key, angled

FW231R

S4 SRI T-wrench

1.1

FW232R

S4 SRI T-wrench with hex chuck

Scope

These instructions for use apply for the following products:

2.2

Areas of use and limitations of use

Art. no.

Name

2.2.1

Intended use

FW225R

S4 Spondylolisthesis Reduction Instrument (SRI)

► For article specific instructions for use and material

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

1.2

see

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 extremely severe injuries may result.

2

The S4 Spondylolisthesis Reduction Instrument (SRI) is used to reduce spondylolisthesis and to reposition dislocated vertebrae in the lumbar spine.

2.2.2

Indications

Indications are described in the relevant chapter of the instructions for use TA011187.

2.2.3

Contraindications

Contraindications are described in the relevant chapter of the instructions for use TA011187.

en 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.

► Only use the instrument with image intensifier

control and/or spinal cord monitoring. ► Avoid over-distraction or over-reduction. ► Do not tighten the reduction device too firmly to

the pedicle screws. The S4 Spondylolisthesis Reduction Instrument (SRI) should be used exclusively with implants of the Aesculap S4 Spinal System. For specific information about S4 implants and instruments, please contact your Aesculap Service Agency or Aesculap directly. Note The product consists in part of NiCoCrMo (MP35N). The material contains cobalt.

2.3.3

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.4

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.

2.4.1

Positioning the screws

Note Positioning the screws is critical. It is recommended to position the monoaxial pedicle screws in parallel in the sagittal plane and to ensure that laterally the monoaxial pedicle screws do not diverge too much. ► Insert the monoaxial pedicle screws into the cranial

2.3.2

Product specific safety information

The decision as to whether and to what extent a reduction is necessary depends on the indication and is the responsibility of the treating surgeon. To ensure a safe reduction, any force must be carefully applied and the spread may not exceed the height of the physiological disc space. improper use may result in injury to the spinal column and nerve roots!

vertebral body according to the anatomical conditions of the patient’s, in parallel to the upper end plate and as parallel to each other as possible.

3

en ► Position the caudal monoaxial pedicle screws such

that they extend in parallel to the cranial monoaxial pedicle screws in both planes (differing from the converging standard screw position). This type of screw positioning permits optimal use of the reduction instrument and facilitates rod placement.

2.4.2

Preparation

► Insert the cylinder piece 1 into the tulip head of the

pedicle screw 2 and use the outer T-handle 4 to bolt the thread on the fitting 3 into the thread in the tulip head of the pedicle screw 2 of the vertebra to be repositioned. ► Insert the inner T-handle 5 to apply counter pressure during tightening, see foldout page. Do not turn the inner T-handle 5 in so doing. The Thandle 5 is used just to apply counter pressure when tightening the outer T-handle 4. ► Position the fitting 3 on the pedicle screw 2 of the other vertebra as described above. ► Insert the distraction spindles 6 into the articular head 7 of the installed fitting. Make sure that the link heads of the feed spindles are positioned at the bottom, see foldout page. Note Using the component marked "R" on the patient's right and the component marked "L" on the patient's left will result in placement of the SRI distraction spindle lateral to the pedicle screws. In taller patients this orientation of the SRI device can cause soft tissue irritation. Alternatively, the system can be reversed by placing the component marked "R" on the patient’s left and the component marked "L" on the patient’s right. This will place the distraction spindle medially from the pedicle screws result in diminished soft tissue irritation.

4

2.4.3

Distraction

► Place standard distraction instrument, e.g. a dis-

traction forceps, between the screw attachments. ► Slowly spread the S4 Spondylolisthesis Reduction

Instrument (SRI) to achieve the desired distraction and use the distraction nut to secure the distraction spindle in this position. ► Spread the vertebral bodies as little as possible (in most a minimal or even no distraction is required). ► For spreading turn the distraction spindle nuts 8 on both sides in the direction of the articulated head, as necessary using the chuck key 9.

2.4.4

Reduction

► Perform the reduction (lordosis, kyphosis) by plac-

ing both T-handles 4 on the two caudal adjusting screws 11 and carefully reduce the spondylolisthesis simultaneously on both sides. ► Monitor the cranial root tension during reduction. Note Best results are usually achieved by one or two turns of the adjusting screw 11 alternating on both sides. A marked decrease in the root tension can be observed during the reduction of spondylolisthesis, .

2.4.5

Securing the reduction

► Fix the achieved vertebral position with an inter-

vertebral spacer or suitable distractor.

2.4.6

Removing the reduction instrument and final assembly

► For distraction, first loosen the distraction screw so

that the frame can be easily removed. ► Remove one side of the instrument by loosening

the outer T-handle 4 while at the same time using the inner T-handle 5 to apply counter pressure. Do not turn the inner T-handle 5 in so doing. The Thandle 5 is only used to apply counter pressure while tightening the outer T-handle 4. ► Insert the the S4 rod.

en ► Insert the S4clamping bolt in the screw head and

3.2

using the designated instrument tighten to the specified torque (as described in the S4 instructions for use). ► To remove the other side of the structure, proceed as described above. ► Once both sides are secured, remove the break-off tabs from the pedicle screws (as described in the S4 instructions for use TA011187).

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.

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.

General information

5

en 3.3 Reusable products ■ There is no maximum number of applications and

3.6

Disassembly

processing cycles for the product.

■ The service life of the product is limited by damage, normal wear, kind and duration of the usage, handling, storage and transportation of the product. ■ Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

3.4

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Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably

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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

8

6

Preparing for cleaning 7

► Do not disassemble anchoring screws/bolts that

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

Fig. 1 ► Pull the reduction lever 10 from the lever. ► Unscrew the adjusting screw 11 from the lever. ► Pull the articulated head of the fitting 7 from the

distraction spindle 6. ► Unscrew the distraction spindle nut 8 from the dis-

traction spindle 6.

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en 3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

Hazardous to patients! The product may not be manually prepared for reuse. ► Prepare the product for reuse only by manual precleaning followed by mechanical cleaning. 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.

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Manual pre-cleaning using ultra-sound, brush and water-pressure pistol and subsequent alkaline machine cleaning and thermal disinfection

Chapter Mechanical clean■ Suitable cleaning brush ing/disinfection with manual ■ Water pressure gun: 3 bar to 4 bar pre-cleaning and subsection: ■ Clean products with movable joints while moving ■ Chapter Manual prethe joints.

Reference

■ Connect the lumens and channels of individual

cleaning with ultrasound and brush

parts directly to the injector unit's special flushing connector.

■ Chapter Mechanical alka-

■ Place the product on a tray that is suitable for

line cleaning and thermal disinfecting

cleaning (avoid rinsing blind spots).

7

en 3.8

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.

3.8.1

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 (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.

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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 3.8.2

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.

9

en 3.9

Inspection

► Assemble disassembled products, see Assembly.

► Allow the product to cool down to room tempera-

► Check that the product functions correctly.

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

► Check that all moving parts are working property

3.9.1

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 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.

3.9.2

(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.

3.10 Assembly

10

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Functional test

CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently oiled! ► Before the functional test, oil any moving parts (e.g. joints, sliding parts and threaded rods) with maintenance oil suitable for the sterilization process (e.g. STERILIT® I oil spray JG600 for steam sterilization or STERILIT® Idrip-feed lubricator JG598).

8

6

7 Fig. 2 ► Insert the reduction lever 10 into the lever. ► Screw the adjusting screw 11 into the lever. ► Screw the distraction spindle nut 8 onto the dis-

traction spindle 6. ► Attach the articulated head of the fitting 7 to the

distraction spindle 6.

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en 3.11 Packaging

4.

Technical service

► 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.

3.12 Steam sterilization Note The product may only be sterilized in 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 fractionated vacuum process – Steam sterilizer in accordance with EN285 and validated in accordance with EN ISO17665 – 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.

CAUTION Modifications of medical equipment may result in the voiding 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.

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

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

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