S4 Rigid Polyaxial Fixation Screwdriver FW156R

S4® Rigid Polyaxial Fixation Screwdriver FW156R Symbols on product and packages Symbol

Explanation Caution, general warning symbol Caution, see documentation supplied with the product

Date of manufacture

Only tested and approved process chemicals (e.g. VAH/DGHM or FDA approval or CE mark) that are, according to the chemical manufacturers' recommendations, compatible with the product's materials may be used for processing the product. All application parameters specified by the chemical's manufacturer, such as temperatures, concentrations and exposure times must be observed under all circumstances. Failure to do so can have the following adverse effects: • 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 ¾ Do not use process chemicals that cause stress cracking or brittleness of plastics. ¾ Clean the product immediately after use. Further detailed advice on hygienically safe and material-preserving/value-preserving reprocessing can be found at www.a-k-i.org ¾ Use suitable cleaning/disinfecting agents if the product is to be put away in wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfecting, thoroughly rinse the product with running water.

Preparation at the place of use ¾ Rinse surfaces that cannot be visually inspected, e.g. on products with hidden gaps or lumens or products with complex geometries, preferably with distilled water, using e.g. a disposable syringe. ¾ Remove visible residues as completely as possible, using a lint-free wet wipe. ¾ Have the product transferred, in dry condition and stored in a closed disposal container, for cleaning and disinfecting within 6 h.

Intended use The S4 Rigid Polyaxial Fixation Screwdriver FW156R is used for the implantation of S4 Pedicle Screws.

Cleaning/disinfection

Safe handling and preparation CAUTION Federal law restricts this device to sale by or on order of a physician! Risk of injury caused by incorrect operation of the product! ¾ Attend relevant product training before using the product. ¾ For information about product training, please contact your national B. Braun/ Aesculap agency. WARNING ¾ Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ¾ Read, follow, and keep the instructions for use. ¾ Use the product only in accordance with its intended purpose, see Intended use. ¾ Remove the transport packaging and clean the new product thoroughly, either by hand or mechanically, prior to initial sterilization. ¾ Store the new or unused product in a dry, clean, and protected place. ¾ Prior to each use, visually inspect the product for: loose, bent, broken, cracked, worn, or fractured parts. ¾ Do not use the product if it is damaged or defective. Immediately set aside the product if it is damaged. ¾ Immediately replace damaged components immediately with original spare parts.

Safe operation

WARNING

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ¾ Use cleaning and disinfecting agents according to the manufacturer’s instructions, that – are approved for plastics and high grade steel. ¾ Observe specifications regarding concentration, temperature and exposure time.

¾ Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, prior to mechanical cleaning/disinfection. – as an integrated mechanical supplement to mechanical cleaning/disinfection. – as an additional process to remove residues left on products after mechanical cleaning/disinfecting

Manual Cleaning/Disinfecting ¾ Clean products featuring movable links with the links open or being moved. ¾ Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution. ¾ Inspect visible surfaces for residues after manual cleaning/disinfecting. ¾ Repeat the cleaning process if necessary.

Manual ultrasonic cleaning and immersion disinfection Risk of injury and/or product malfunction! ¾ Always carry out a function check prior to using the product. ¾ Do not bend the screwdriver or exercise levering forces. ¾ Do not overtighten or tighten by mechanical means the threaded shaft of the screwdriver. Risk of implant damage due to use of inappropiate screwdriver! ¾ Only use the screwdriver with Polyaxial S4 Pedicle Screws.

Stage

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

BBraun Stabimed; aldehyde-, phenol-free and QAV-free

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfecting

RT (cold)

15

2

D–W

BBraun Stabimed; aldehyde-, phenol-free and QAV-free

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Drying

RT

-

-

-

-

CAUTION ¾ Do not use the screwdriver with torque wrenches or for interface with set screws. ¾ Do not use the tip of the screwdriver as a lever since it is fragile. ¾ Remove any part of this instrument that became disassociated from the main instrument from the patient as it is not implantable.

Validated reprocessing procedure Note Adhere to national law and regulations, international standards and guidelines, 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 the products. Note Mechanical reprocessing should be preferred over manual cleaning because of the better and more reliable cleaning results of mechanical processing. Note Please note that successful processing of this medical product can be ensured only through a validated processing procedure. Responsibility for the validation lies with the user/processor. Note Up-to-date information on reprocessing can be found on the Aesculap Extranet at www.aesculap-extra.net

General information To avoid unnecessary, excessive contamination of the entire instrument tray, care must be taken at the stage of application that contaminated instruments are collected separately and not put back into the instrument tray. Encrusted or fixated surgical residues can make cleaning more difficult or ineffective, and can cause corrosion of stainless steel products. 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: aldehyde, alcohol) should be used. Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of laser inscriptions, in terms of visual reading and machine-readability, on stainless steel surfaces. Residues containing chlorine or chlorides, e.g. surgical residues or residues from medicines, saline solutions and service water used for cleaning, disinfecting and sterilizing will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. To remove such residues, the products must be adequately rinsed with fully desalinated water, followed by thorough drying.

D–W: FD–W: least) RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at Room temperature

Stage I ¾ Clean the product in an ultrasound cleaning bath (frequency 35 kHz) for at least 15 minutes. Make certain all accessible surfaces are moistened and acoustic shadows are avoided. ¾ Clean the product with a suitable cleaning brush, until all visible residues have been removed from the surface. ¾ Brush through all surfaces not accessible to visual inspection, e.g. in products with hidden gaps, lumens or complex geometries, for at least 1 min or until no more residues can be removed, using a suitable cleaning brush (e.g. TA011944, TE654202, GK469200). ¾ Mobilize non-rigid components such as set screws, links, etc. during cleaning. ¾ After cleaning, thoroughly rinse through these components (at least five times) with the cleaning solution, using a disposable syringe (20 ml). ¾ Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. Stage II ¾ Rinse (through) the entire product (all accessible surfaces) under running water. ¾ Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ¾ Allow residual water to drip off sufficiently. Stage III ¾ Fully immerse the product in the disinfecting solution. ¾ Mobilize non-rigid components, such as set screws, joints, etc. during disinfecting. ¾ Rinse lumens at least 5 times, using a disposable syringe (20 ml) and an appropriate rinsing adapter. Make certain all accessible surfaces are moistened by the solution. Stage IV ¾ Rinse (through) the entire product (all accessible surfaces). ¾ Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ¾ Rinse lumens at least 5 times, using a disposable syringe (20 ml) and an appropriate rinsing adapter. ¾ Allow residual water to drip off sufficiently. Stage V ¾ Dry the product completely with lint-free tissue or medical-quality compressed air.