S4 Spinal System – Torque wrench

en Aesculap® S4® Spinal System – Torque wrench Legend 1 Dynamometric Wrench FW170R 10 Nm for locking screw in screw head/hook head 2 Dynamometric Wrench FW207R 4 Nm for locking screw in cross connector A Indicator arrows

1.

About this document

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

1.1

WARNING The improper attachment of the cross connector may result in injuries! ► In tightening the locking screws, make sure the cross connector fully rests on the rods. ► Fully tighten the locking screw on the cross connector using the torque wrench FW207R (4 Nm) CAUTION Over-tightening the locking screw may damage the implant! ► Tighten locking screw slowly using dynamometric wrench FW170R until the display arrow points to 10 Nm.

Scope

► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at

eifu.bbraun.com

1.2

WARNING The improper mounting of the locking screw can result in injury/loss of correction! ► Position the locking screw correctly. ► Make sure that the rods are positioned correctly at the bottom of the groove. ► Only break off flanks after the locking screws have been fully tightened. ► When tightening the locking screw, always withstand with the appropriate counter-holding instrument.

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

CAUTION The improper use for loosening screws can damage the torque wrenches! ► Always use the proper revision screwdriver to loosen tightened loosening screws. CAUTION Improper use can damage the counterholder! ► Always slide the counterholder all the way on the rod over the screw head. Make sure the rod is fully inside the slit at the working end. ► Ensure that the rod projects beyond the counterholder on both sides. The torque wrenches FW170R and FW207R are dynamometric wrenches. ► Prior to using the dynamometric wrenches FW170R and FW207R, make sure the display arrows A point to zero. ► To prevent reading errors, always take parallel readings from the dynamometric wrenches. ► Tighten screws evenly, using clockwise turns of the torque wrench. Be careful not to jerk the torque wrench.

3.

Validated reprocessing procedure

The S4 Spinal System - Torque wrenches are used to secure the S4 Spinal System - locking screws using defined torque: ■ 10 Nm to tighten the locking screw in the screw head/hook head (FW170R torque wrench) ■ 4 Nm to tighten the locking screw in the cross connector (FW207R torque wrench)

3.1

General safety information

2.1.2

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.

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

► Do not lever during use. ► Read and observe the operating manuals listed below and keep them in a safe place:

– – – –

2.2.3

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

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

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 Using an untested dynamometric wrench can result in injury/loss of correction! ► Prior to each use, check whether the next service date has been reached. ► Do not use a torque wrench if the service interval has expired. ► Send any torque wrenches of which the service interval has expired to the technical service department for testing, see Maintenance. WARNING Using a defective dynamometric wrench can result in injury/loss of correction! ► Prior to every use, check whether the display arrows point to zero. ► Do not use a torque wrench showing a deviation from the zero position.

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

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".

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

Cleaning/Disinfection

3.5.1

Product-specific safety information on the reprocessing method

Hazardous to patients! The product may not be processed manually. ► Only mechanically process the product. 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. ► For wet disposal use suitable cleaning agents/disinfectants. To prevent foam formation and reduced effectiveness

of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly under running water

3.5.2

4.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Alkaline machine cleaning and thermal disinfection

■ Place the product on a tray that

Chapter Machine cleaning/disinfection and sub-sections:

is suitable for cleaning (avoid rinsing blind spots).

■ Chapter Mechanical alkaline

■ Open the links and joints before

cleaning and thermal disinfection

placing the product in the screen basket.

3.6

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.

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

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

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

Phase

TA011495

3.6.1

Mechanical alkaline cleaning and thermal disinfection Step

T [°C/°F]

I

Pre-rinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

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

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.

3.7

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.7.1

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the 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.

3.7.2

Functional test

CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently oiled! ► Oil any moving parts (e.g. joints, slide 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). ► Check that the product functions correctly. ► 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.

3.8

Packaging

► Secure products that have ratchet locks fully opened or locked no further than in the first notch. ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.9

Steam sterilization

► 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

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Maintenance and service

4.1

Maintenance and repair

The dynamometric wrenches FW170R and FW207R have been calibrated to 10 Nm and 4 Nm, respectively, by the manufacturer. If the indicator arrows do not point to zero when the torque wrench is not loaded, the wrench is defective and may not be used under any circumstances. ► Replace torque wrench if damaged.

2020-10

V6

Change No. 62188