BBraun

ABC explantation instruments

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B 1

B B

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F 7

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C 2

Aesculap® ABC ABC explantation instruments Legend A B C D E F a b

ABC explantation screwdriver FJ837R ABC E-Plate bit, conical FJ847R ABC explantation bit, straight FJ848R Needle holder BM221R ABC extractor for locking pin FJ896R ABC screw segment break-off instrument FJ897R Outwards Inwards

The product is gamma-sterilized and supplied in sterile packaging. The product must not be reused. ► 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. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

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

Symbols on product and packages Sterilization using irradiation

► To remove the ABC screws, follow steps 1 to 5.

Step 1

Sterilization with steam or dry heat

CAUTION Not for reuse in intended applications as defined by the manufacturer

Use by CAUTION

Risk of the ABC E plate bit breaking and damage to the ABC screw caused by overtorquing or lateral bending with the screwdriver! Risk of the ABC E-Plate bit breaking and/or damage to the ABC screw if the ABC E-Plate bit is not fully inserted into the screw head! ► Avoid strong, abrupt movements with the screw driver. ► ABC Always insert the E-Plate bit fully in the screw head. Risk of damage to the ABC screw and ABC plate if the straight ABC explantation bit C with the white marking is used in step 1! ► Always use the conical ABC E-Plate bit in step 1. ► Carry out steps 2 and 3 before using the straight ABC explantation bit C.

► Insert conical ABC E-Plate bit B (black marking) into ABC explantation screwdriver A, see Fig. 1. ► Insert ABC E-Plate bit B fully into the head of the ABC screw 2 and unlock locking pin 1 of the ABC screw, see

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

Fig. 2. ► Press on the screwdriver with your hand; at the same time turn the screwdriver counterclockwise with gradually

increased torque, until the screw is released from the bone. ► Unscrew the ABC screw.

Date of manufacture

Step 2 ► If the screw cannot be removed as described in Step 1 and the conical ABC E-Plate bit B (black marking) has

broken off, grasp the broken off bit with needle holder D and remove. ► To remove the broken bit from the screwdriver A, push the holding sleeve 3 forwards. ► Lock the locking mechanism of the ABC screw by using the ABC locking instrument FJ828R in the usual way, see

instructions for use for ABC instruments TA009777.

Applicable to

► To activate the ABC extractor for locking pin E, turn the outer sleeve counterclockwise until an audible click is

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

at https://extranet.bbraun.com

heard. The "click" signals that the extractor is activated and can be used to extract the locking pin. Note The directions in which turning knob 4/T-handle 5 i are then turned can be seen from the arrows on the turning knob and T-handle, see Fig.. 3.

Intended use The ABC explantation instruments listed are used for the explantation of the ABC plate, the ABC E-Plate plate, and the ABC screws for anterior cervical stabilization. The special instruments for the explantation of ABC implants are mainly manufactured from stainless instrument steel (ISO 7153/1).

► Turn turning knob 4 clockwise to screw in the ABC extractor for locking pin E in violetten Verriegelungspin 1,

see Fig. 4. ► As soon as the tip of the ABC extractor for locking pin E is fully screwed into the purple locking pin, turn T-

handle 5 clockwise to remove the pin from the screw.

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.

WARNING

Risk of injury to the patient if the pin is inadvertently dropped and lost! ► Ensure that the pin does not fall out inadvertently; it is small and difficult to find. ► To remove the locking pin, hold the pin extraction instrument over a suitable receptacle or a surgical table.

► To remove the pin 1 from the ABC extractor for locking pin E, hold turning knob 4 and turn T-handle 5 counter-

clockwise until the pin comes out, see Fig. 5. ► To reactivate the ABC extractor for locking pin E, turn the outer sleeve counterclockwise until an audible click is

heard. The operating surgeon must be thoroughly conversant with stabilization techniques for, and the biomechanical properties of, the cervical spine. He must be familiar with all theoretical and practical aspects of the operating technique for the ABC system and the ABC E-Plate. ► 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 the ABC E-Plate (TA011799), the ABC plates and screws (TA009693), the ABC E-Plate instruments (TA011800) and the ABC instruments (TA009777). ► Comply with the operating manual of the ABC E-Plate (brochure no. O27102) and of the ABC system (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).

DANGER

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

Art. no.

Designation

FJ847R

ABC E-Plate bit, conical

FJ848R

ABC explantation bit, straight

Step 3 ► Remove segments of the ABC screw with the ABC screw segment break-off instrument F.

Risk of injury to the patient if screw segments are inadvertently dropped and lost! ► To remove a screw segment from the screw segment break-off instrument, hold this over a suitable receptacle or a surgical table. WARNING Damage to the ABC screw segment break-off instrument if more than one segment of the screw head is grasped! ► Always only grasp and break off one screw segment each time. CAUTION Damage to the screw segment break-off instrument and ABC plate if too much pressure is applied or pressure is applied inwards at first! ► Always press outwards first. CAUTION ► Insert the tip of the ABC screw segment break-off instrument 6 at an angle into the middle of the screw head,

see Fig. 6. ► To grasp one of the segments, press together handles 7. ► To break off a screw segment, first press outwards then inwards. ► Repeat this process until all screw segments have been removed.

Step 4

Disassembling the product before carrying out the reprocessing procedure

► Insert straight ABC explantation bit C (white marking) into ABC explantation screwdriver A, see Fig. 7. ► Insert ABC explantation bit C fully into the ABC screw head.

► Disassemble the product immediately after use, as described in the respective instructions for use. ► Open up instruments with hinges.

CAUTION

Risk of the ABC explantation bit breaking and damage to the ABC screw caused by overtorquing or lateral bending with the screwdriver! Risk of the ABC explantation bit breaking and/or damage to the ABC screw if the ABC explantation bit is not fully inserted into the screw head! ► Avoid strong, abrupt movements with the screw driver. ► Always insert the ABC explantation bit fully in the screw head.

► Press on ABC screwdriver A with your hand; at the same time turn the screwdriver counterclockwise with grad-

ually increased torque, until the screw is released from the bone. ► Unscrew the ABC screw 2.

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.

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

Cleaning/disinfection Step 5 ► To remove further screws, repeat steps 1 to 4. ► If necessary, remove ABC plate with needle holder D.

Product-specific safety notes on the reprocessing procedure

Disassembling CAUTION ABCextractor for locking pin FJ896R ► Rotate sleeve 8 in a counterclockwise direction, see Fig. 8. ► Extract turning knob 4 in the direction of the arrow. Sleeve 8remains on the shaft.

Assembling ABC extractor for locking pin FJ896R ► Press turning knob 4 in the opposite direction of the arrow, see Fig. 8. ► Turn sleeve 8 clockwise. ► To activate the ABC extractor for locking pin E, turn the outer sleeve 5 counterclockwise until an audible click is heard.

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. 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. 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.

Hazard caused by inadequate cleaning, disinfection and sterilization! ► Always clean explantation screwdriver FJ837R with ultrasound prior to mechanical or manual cleaning. CAUTION ► 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.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable

Chapter Manual cleaning/disinfection and sub-chapter:

■ FJ897R

Single-use products

WARNING

■ Chapter Manual cleaning with immersion disinfection

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

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.

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.

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

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

■ FJ896R ■ FJ897R

■ Connect components with lumens and chan-

for cleaning (avoiding rinsing blind spots). nels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place instruments in the tray with their hinges

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

open. Art. no.

Designation

FJ847R

ABC E-Plate bit, conical

FJ848R

ABC explantation bit, straight

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.

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

■ FJ837R

■ Cleaning brush ■ 20 ml disposable syringe ■ Mount jaws protection on the product. ■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

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

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Connect components with lumens and chan-

■ Chapter Mechanical alka-

nels directly to the rinsing port of the injector carriage.

line cleaning and thermal disinfecting

■ Keep working ends open for cleaning. ■ Place instruments in the tray with their hinges open.

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

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

Manual cleaning with immersion disinfection

Manual pre-cleaning with ultrasound and brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfecting cleaning

RT (cold)

>15

D–W

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

Ultrasonic cleaning

RT (cold)

>15

D–W

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

Intermediate rinse

RT (cold)

D–W

Rinsing

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: 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. D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► 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 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.

Mechanical alkaline cleaning and thermal disinfecting 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: – pH = 13 – <5 % anionic surfactant

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 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► 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.

■ 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

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).

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

Inspection, maintenance and checks

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush CAUTION Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfectant cleaning

RT (cold)

>15

D–W

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

Rinsing

RT (cold)

D–W

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-

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. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products. Note Intensive use of the instruments leads to normal wear.

Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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 Note The product can be sterilized either in disassembled or in assembled condition. Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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

– Disassemble the instrument – Steam sterilization through 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. ► Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.

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. 011500

2017-12

Änd.-Nr. 57993

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