S4 Cervical Spinal System – Occipital Torque Wrench FW103R

Validated reprocessing procedure

en ®

Aesculap S4® Cervical Spinal System – Occipital Torque Wrench FW103R Legend 1 2 3 4

General safety instructions 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.

Thumb nut Smooth surface Hexagonal bit Integrated screws

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

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used.

SN

Manufacturer's serial number

Applicable to

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

General information

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at https://extranet.bbraun.com

Intended use The S4 Cervical Spinal System torque wrenches with click function are used to tighten the S4 Cervical System set screws with a defined torque: ■ 2.8 Nm for tightening the set screw in the screw head/hook head/occipital plate/transverse connector and other connectors.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts.

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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use.

Safe operation

Preparations at the place of use

► Make sure that the instrument is correctly mounted and that the hexagonal bit is firmly fixed. ► Tighten the set screws, turning the torque wrench evenly in a clockwise direction. In doing so, make sure that

► 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.

the torque wrench is turned without jerking. ► Instrument will click when the defined torque is obtained.

WARNING

WARNING

Risk of injury/correction loss due to improper mounting of the set screw! ► Set the set screw in place correctly. ► Make certain that the rods are correctly positioned in the body of the polyaxial ► When tightening the set screw always apply counter torque using the countering instrument intended for this purpose. Risk of injury due to improper mounting of the transverse connector! ► When tightening the set screw make sure that the transverse connector is completely seated on the rods. ► Fully tighten the set screw on the transverse connector using the torque wrench. Risk of damage to the implant by applying excess torque to the set screw! ► Slowly tighten the set screw using the torque wrench, until the torque wrench clicks.

CAUTION

► Disassemble the product prior to cleaning, see Disassembling.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for (e.g. aluminum, plastics, high-grade steel), – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable washing temperature of 55 °C.

► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. Risk of damage to the torque wrench due to improper usage! ► To undo a tightened set screw always use the set screw removal screwdriver FW064R.

CAUTION

CAUTION

Preparation before cleaning

Damage to the countering instrument due to improper usage! ► Always slide the countering instrument over the rod receptacle head as far as it will go. In doing so, make sure that the implant entirely engages into the slot at the working tip. ► Make sure that the rod protrudes on both sides of the countering instrument.

► Carry out ultrasound cleaning:

– as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: e.g. TA011944,

Chapter Manual cleaning/disinfection and sub-chapter:

■ When cleaning products with

Wrong assembly leads to malfunction of the instrument! ► Make sure that the instrument is assembled correctly.

movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

CAUTION

Disassembling ► Unscrew the thumb nut 1 from the rear of the wrench head, see Fig. A. ► Remove the hexagonal bit 3 from the inner surface of the wrench head, see Fig. B. ► Take care not to lose the hexagonal bit and the thumb screw.

Assembling ► After cleaning, reassemble the hexagonal bit 3 in the torque wrench by inserting it into the bit cavity on the

inner surface of the torque wrench head, see Fig. A. The inner surface of the torque wrench can be identified by the two integrated screws 4. ► Engage the thumb nut 1 on the rear of the wrench head and securely tighten, see Fig. B The rear of the wrench can be identified by the smooth surface 2.

TE654202, GK469200

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush: e.g. TA011944, TE654202, GK469200

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with their hinges open.

■ Chapter Manual cleaning with immersion disinfection

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting