MACS TL thoracic screwdriver Instructions for Use

Validated reprocessing procedure Aesculap® MACS TL® MACS TL® thoracic screwdriver

General safety instructions

Legend

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.

1 Screw sleeve 2 Retaining tongues 3 Screw the knurled nut

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

Explanation

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.

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

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

Symbols on product and packages Symbol

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

Note For up-to-date information about 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.

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

at https://extranet.bbraun.com

Intended use The MACS TL® thoracic screwdriver is used to implant the MACS TL® thoracic stabilization screw.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Applying the MACS TL® thoracic screwdriver requires precise knowledge about spine stabilization and the biomechanical situation at the spine. Operative use of the MACS TL® instrument set is described in detail in the relevant O.R. manual. ► Prior to first application, thoroughly read the O.R. manual for the MACS TL® thoracic screwdriver. ► 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. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

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.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.

Preparations at the place of use

Safe operation Mispositioning of the screw can cause extremely severe complications for the patient! ► Always maintain radiographic control through all steps of the operation. DANGER

► 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.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

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

WARNING To insert the screw: ► Insert the tip of the thoracic screwdriver MACS TL® into the hexagonal socket of the screw. ► Turn knurled nut3 clockwise to fixate the screw on the MACS TL® thoracic screwdriver. ► Screw the screw into the bone through the guide sleeve using the MACS TL® thoracic screwdriver. ► Turn knurled nut 3 counterclockwise to loosen the screw from the MACS TL® thoracic screwdriver. ► Pull the thoracic screwdriver MACS TL® out.

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 permitted cleaning temperature of 60 °C.

Disassembling The MACS TL® thoracic screwdriver will not function properly if the retaining tongues are bent or kinked! ► Do not bend or crimp the retaining tongues. CAUTION

► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► 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. ► Carry out ultrasound cleaning:

► Unscrew screw sleeve 1. ► Unscrew knurled nut 3 and push it, together with the retaining tongues 2, over the shaft of the MACS TL® tho-

racic screwdriver.

Assembling

– 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 The MACS TL® thoracic screwdriver will not function properly if the retaining tongues are bent or kinked! ► Do not bend or crimp the retaining tongues.

CAUTION ► Push knurling nut 3 with retaining tongues 2 on to the shaft of the MACS TL® thoracic screwdriver in such a way

that the retaining tongues 2 are guided in the grooves of the shaft. ► Turn knurled nut 3 onto the thread, but do not tighten it. ► Screw the screw sleeve 1 onto the tip of the MACS TL® thoracic screwdriver and tighten it down.

Validated procedure

Specific requirements

Reference

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

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that

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

is suitable for cleaning (avoiding rinsing blind spots).

■ Keep working ends open for cleaning.

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting