BBraun

ABC system for anterior cervical fusion – Screwdriver FJ846R –

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File Name: BBraun - ABC - TA009846 - ABC system for anterior cervical fusion – Screwdriver FJ846R – - 2017-12.pdf

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► Detach the screwdriver B from the screw head 5. If the screwdriver B cannot be removed:

Aesculap ABC ABC system for anterior cervical fusion – Screwdriver FJ846R –

– If the ABC screw has not been fully screwed into the plate hole, screw the ABC screw in deeper by 1/4 to 1/2 turns. – If the ABC screw has been screwed in too deeply, loosen the ABC screw by 1/4 to 1/2 turns, see Fig. 1.

Legend 1 Shaft 2 Sleeve 3 Handle

5 4

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product Fig. 1

Screw fully screwed in (left), screw not fully screwed in (right)

Removing an ABC screw

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

Damage to the ABC screw through incorrect application of the screwdriver when screwing into the ABC plate! ► Fully insert the tip of the screwdriver into the screw head.

at https://extranet.bbraun.com

Intended use

CAUTION

The ABC screwdriver FJ846R is used exclusively for screwing in and out the ABC screws of the Aesculap ABC system for anterior cervical fusion.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! 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. ► Observe the instructions for use of ABC plates and ABC screws (TA009693 and TA009911), ABC instruments (TA09777) and the operating manual (brochure no. O17702). ► 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).

CAUTION

► To unlock the ABC screw, use the screwdriver B to push the locking pin 7 into the screw. ► Turn the screwdriver B to remove the ABC screw, see Fig. F.

Note If ABC screws turn without any resistance, use ABC revision instrument FJ829R (see TA009777).

Validated reprocessing procedure General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

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

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

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

Screwing in an ABC screw Damage to the ABC screw through incorrect application of the screwdriver when screwing into the ABC plate! ► Fully insert the tip of the screwdriver into the screw head. CAUTION

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. 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.

General information Damage to the ABC screwdriver and the ABC screw or breakage of the screwdriver tip, respectively, through angled insertion or tilting of the screwdriver! ► Always align the screwdriver shaft with the screw axis.

CAUTION

Damage to the ABC screwdriver and the ABC screw or breakage of the screwdriver tip, respectively, through angled insertion or tilting of the screwdriver! ► Always align the screwdriver shaft with the screw axis.

Damage to or breakage of the ABC screwdriver by deflecting the screwdriver handle beyond the acoustic signal (“click”)! ► Do not deflect the screwdriver handle beyond 20° against the shaft axis. An acoustic signal indicates that maximum permissible angle has been reached. ► Never bend the screwdriver at the shaft when fitting a screw. Damage to the ABC screwdriver and the ABC screw or incorrect locking of the ABC screw through incomplete engagement in the hole of the ABC plate! ► Ensure that the ABC screw fully engages in the hole of the ABC plate.

CAUTION ► Never use the screwdriver B without the screw holding sleeve A. ► Slide the screw-holding sleeve A onto the screwdriver B. ► Fully insert the tip 4 of the screwdriver B into the screw head 5.

The locking pin is pushed down and unlocks the ABC screw. ► Slide the screw-holding sleeve A over the screw head 5, see Fig. C. ► Screw ABC screw into the hole of the ABC plate 6 by applying mild pressure with screwdriver B, until the screw

head 5 fully engages in the screw hole, see Fig. D. Note The handle of the screwdriver can be angled by up to 20° against the shaft axis. An acoustic signal indicates that maximum permissible angle of the handle has just been reached. The handle returns to the axial position as soon as it is released, see Fig. E.

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

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 – be 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-

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.

Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

Mechanical cleaning/disinfection with manual pre-cleaning 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.

Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Ultrasonic cleaning

RT (cold)

>15

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Rinsing

RT (cold)

D–W

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ When cleaning instruments with mov-

Chapter Manual cleaning/disinfection and sub-chapter:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

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

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

■ Drying phase: Use a lint-free cloth or medical compressed air Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ Place the instrument in a tray that is

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subchapter:

■ Chapter Manual pre-cleaning with

suitable for cleaning (avoiding rinsing blind spots).

ultrasound and brush

■ Chapter Mechanical alkaline clean-

■ Place instruments in the tray with their

ing and thermal disinfecting

hinges open.

Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

Mechanical alkaline cleaning and thermal disinfecting

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

Prerinse

<25/77

D–W

Cleaning

55/131

FD-W

■ Concentrate, alkaline:

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Ultrasonic cleaning

RT (cold)

>15

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Intermediate rinse

RT (cold)

D–W

III

Disinfection

RT (cold)

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Final rinse

RT (cold)

FD-W

Drying

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

FD-W

Thermal disinfecting

90/194

FD-W

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 alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Inspection, maintenance and checks

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

CAUTION

Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Check for compatibility with associated products.

Packaging ► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

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 fractionated 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 ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.

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

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 009846

2017-12

Änd.-Nr. 57993

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