ABC system for anterior cervical fusion – Drill FJ840R –

Validated reprocessing procedure Aesculap® ABC ABC system for anterior cervical fusion – Drill FJ840R –

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 Stop 2 Insertion shank 3 Ball joint

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.

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.

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

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.

at https://extranet.bbraun.com

General information

Intended use Drill FJ840R may only be used with instruments from the Aesculap ABC system for anterior cervical fusion. The drill is operated manually with the ABC drill handle FJ839R or with a motor system and Aesculap Intra handpiece (e.g. GD450R/GD456R).

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

The operating surgeon must be thoroughly conversant with stabilization techniques for, and the biomechanical properties of, the cervical spine. He must also be familiar with the theory and practice of operative techniques within the ABC system. ► 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).

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.

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.

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

Safe operation

DANGER

Risk to patients! ► The product must only be cleaned mechanically! Risk of drilling into the patient’s spinal cord as a result of the cutting depth set incorrectly on the drill guide! ► Insert drill FJ840R into the drill guide and check the preset cutting depth with a caliper (e.g. AA845R, Caspar instruments for anterior cervical fusion).

Risk of screw damage and bone trauma! The stop will not stop a sharpened drill. ► Never repoint the drill. ► Replace blunt drills with new ones.

DANGER

CAUTION

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

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 plastic material and 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.

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

WARNING Risk of incorrect cutting depth and damage from a sharpened and truncated drill! ► Never repoint the drill. ► Replace blunt drills with new ones. CAUTION ► To adjust the required depth with depth-adjustable drill guides FJ822R and FJ823R, turn guide sleeve of the drill

guide in direction + or –. ► To position the screw hole correctly, insert the end of the drill guide all the way into the plate hole. ► Drill to the preset cutting depth.

The drill will be stopped by the stop 1. Note For detailed information regarding the intraoperative procedure, see TA009777.

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

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Mechanical alkaline cleaning and thermal disinfection

■ Place the instrument in a tray

Chapter Mechanical cleaning/disinfecting and sub-chapter:

that is suitable for cleaning (avoiding rinsing blind spots).

■ Chapter Mechanical alkaline cleaning and thermal disinfecting