Apfelbaum instruments

en

2.1.2 ®

Aesculap Apfelbaum instruments

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

Legend

2.1.3

1 Odontoid guide sleeve (FJ962R) 2 Handle 3 Locking knob 4 Guide sleeve C1-C2 (FJ982R) 5 Odontoid inner drill sleeve (FJ963R) 6 Slide 7 Release button 8 Adjustable stop 9 Apfelbaum C1-2 inner sleeve guide (FJ985R) 10 Odontoid impactor (FJ964P) 11 Slot 12 Odontoid screwdriver (FJ969R) 13 Screw sleeve 14 Retaining tongue 15 Knurled nut 16 Screwdriver C1-C2 (FJ989R) 17 Cervical retractor (BW079R) 18 Counter retractor (BV739R) 19 C1-C2 obturator (FJ983R) 20 C1-C2 trocar (FJ984R) 21 Odontoid tap (FJ967R) 22 C1-C2 tap (FJ987R) 23 Odontoid hollow core drill (FJ965R) 24 Odontoid ball end driver (FJ968R) 25 C1-C2 ball end driver (FJ988R)

No known contraindications.

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for the following products: Art. no.

Designation

BV739R

APFELBAUM COUNTER RETRACTOR

BW079R

APFELBAUM CERVICAL RETRACTOR

FJ962R

APFELBAUM ODONTOID SLEEVE GUIDE

FJ963R

APFELBAUM ODONTOID INNER SLEEVE GUIDE

FJ964P

APFELBAUM ODONTOID IMPACTOR FOR FJ962R

FJ965R

APFELBAUM ODONTOID HOLLOW CORE DRILL

FJ967R

APFELBAUM ODONTOID TAP

FJ968R

APFELBAUM ODONTOID BALL END DRIVER

FJ969R

APFELBAUM ODONTOID 2.5MM HEX DRIVER

FJ982R

APFELBAUM C1-2 SLEEVE GUIDE

FJ983R

APFELBAUM C1-2 OBTURATOR FOR FJ982R

FJ984R

APFELBAUM C1-2 TROCAR

FJ985R

APFELBAUM C1-2 INNER SLEEVE GUIDE

FJ987R

APFELBAUM C1-2 TAP

FJ988R

APFELBAUM C1-2 BALL END DRIVER

FJ989R

APFELBAUM C1-2 2.5MM HEX DRIVER

Contraindications

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.2.2

Product

Product-specific safety information 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. In order to use the Apfelbaum instruments, the operator must have precise knowledge regarding the stabilization and biomechanical properties of cervical vertebrae. For information regarding the operative use of the Apfelbaum odontoid instruments, see O.R. manual (Aesculap cat. no.: O-507-02). For information regarding the operative use of the C1-C2 instruments, see operating manual (Aesculap cat. no.: O508-02). ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

2.2.3

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

2.3.1

Odontoid instruments

Instruments may be combined as follows for odontoid screw fixation: ■ Inner drill sleeve 5 only with guide sleeve 1 ■ Impactor 10 only with inner drill sleeve 5 and guide sleeve 1 ■ Odontoid tap 21 only with guide sleeve 1 ■ Screwdriver 12 DANGER The patient can suffer from extremely severe complications if instruments or implants are positioned incorrectly! ► Carry out operative steps with radiographic visualization. ► Position the Kirschner wire perpendicular to the odontoid process in the second cervical vertebra. ► Place the hollow drill 23 over the Kirschner wire and prepare the third cervical vertebra to accommodate the

guide sleeve and inner drilling sleeve. Note The applicable CE mark for the product can be seen on the label or packaging of the product.

► Slot the inner drill sleeve 5 into the guide sleeve 1.

► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

► Place the inner drill sleeve 5 with the guide sleeve 1 over the Kirschner wire in the operating field. ► Release locking knob 3 (max. 1 rotation) to position the handle 2.

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The Apfelbaum instruments consist of the odontoid and C1-C2 instruments. The Apfelbaum odontoid instruments are used only for odontoid screw fixation in cervical vertebrae. The Apfelbaum C1-C2 instruments are used only for Magerl screw fixation in cervical vertebrae. The Apfelbaum instruments are used to prepare screw anchors, as well as to position and insert Apfelbaum implantation screws.

The inner drill sleeve 5 snaps into place and remains rotatable.

The handle 2 can be rotated around the guide sleeve 1 in increments of 22.5°. ► Snip off the Kirschner wire behind the adjustable stop 8 ► Place the impactor 10 over the inner drilling sleeve 5 on the guide sleeve 1 in such a way that both the handle 2 of the guide sleeve 1 and the slide 6 on the inner drilling sleeve 5 are seared in the slot 11 of the impactor 10. If necessary, rotate the handle 2 on the inner drilling sleeve 5 around the guide sleeve 1. ► Make certain to leave a space of at least 5 mm between the bottom of the impactor 10 and the end of the Kirschner wire. ► To fix the guide sleeve 1 and its spikes to the third cervical verterbra, hammer in the guide sleeve 1. When doing

this, make certain that the Kirschner wire is not driven in. DANGER The patient can suffer from severe complications the guide sleeve is positioned incorrectly! The position of the guide sleeve affects all subsequent operative steps. ► When withdrawing the Kirschner wire, as well as during subsequent operative steps, make certain that the guide sleeve remains firmly in place in the third cervical vertebra. ► Remove impactor 10 and Kirschner wire. ► Press the release button 7 to position the stop 8 (maximum adjustment range 24 mm, in ratcheted 1 mm incre-

ments). ► Press the release button 7 to allow the stop 8 to snap into place. ► To prepare a bone for thread cutting, drill a hole using drill FJ966R or FJ976R, see instructions for use TA010744. ► Press down on the slide 6 and remove the inner drilling sleeve 5 from the guide sleeve 1. ► To prepare the drill hole for screw fitting, cut threads with odontoid tap 21.

► To insert the screw:

– Insert the tip of the screwdriver 12 into the hexagon socket of the screw. – Turn the knurled nut 15 clockwise, to fix the screw to the screwdriver 12. – Secure the screw and screwdriver 12 working through the guide sleeve 1 in the drill hole in the bone. – Turn the knurled nut 15 counterclockwise, to release the screw from the screwdriver 12. – Remove 12 screwdriver. ► Pull the guide sleeve out of the anchor for the third cervical vertebra and out of the operative field.

2.3.2

C1-C2 instruments

Instruments may be combined as follows for C1-C2 screw fixation: ■ Inner sleeve guide 9 only with guide sleeve 4 ■ Guide sleeve 4 only with obturator 19 and trocar 20 ■ Screwdriver 16 only with guide sleeve 4 DANGER The patient can suffer from extremely severe complications if instruments or implants are positioned incorrectly! ► Carry out operative steps with radiographic visualization. ► Push the obturator 19 into the guide sleeve 4.

The obturator snaps into the guide sleeve 4 and remains rotatable. DANGER The patient can suffer from severe complications the guide sleeve is positioned incorrectly! The position of the guide sleeve affects all subsequent operative steps. ► When removing the obturator, as well as during subsequent operative steps, make certain that the guide sleeve remains firmly in place. ► Place the guide sleeve 4 with obturator in the operative field. ► Press down on the slide on the obturator 19 and remove the obturator from the guide sleeve 4. ► Place the trocar 20 into the guide sleeve 4 to pierce the cortical bone. ► Push the inner sleeve guide 9 into the guide sleeve 4.

The inner sleeve guide 9 snaps into place and remains rotatable. ► To prepare a bone for thread cutting, drill a hole using drill FJ986R, see instructions for use TA010744. ► Press down on the slide 6 and remove the inner sleeve guide 9 from the guide sleeve 4. ► To prepare the drill hole for screw fitting, cut threads with thread cutter 22. ► To insert the screw:

– Insert the tip of the screwdriver 16 into the hexagon socket of the screw. – Turn the knurled nut 15 clockwise, to fix the screw to the screwdriver 16. – Secure the screw and screwdriver 16 working through the guide sleeve 4 in the drill hole in the bone. – Turn the knurled nut 15 counterclockwise, to release the screw from the screwdriver 16. – Remove 16 screwdriver. ► Remove the guide sleeve 4 from the operating field.

2.3.3

Retractors

3.

Validated reprocessing procedure

3.1

General safety instructions

■ Counter retractor 18 may be combined with retractor blades BV741T to BV746T and cervical retractor 17. ■ Cervical retractor 17 may be combined with retractor blades BW153T to BW157T.

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.

3.6

Disassembly

3.6.1

Disassembling the screwdriver

CAUTION The screwdriver will not function properly if the retaining tongues are bent or crimped! ► Do not bend or crimp the retaining tongues. ► Unscrew screw sleeve 13. ► Unscrew the knurled nut 15 and push it, together with the retaining tongues 14 over the shaft of the screw-

driver.

3.6.2

Disassembling the guide sleeve

► Loosen the locking shaft counterclockwise, unscrew and remove from the handle by pulling in the direction of

the arrow.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for (e.g. aluminum, plastics, high-grade steel), – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. For products with plasma layers (e.g. Noir instruments), the layer is attacked or removed when special cleaning procedures with the addition of oxidizing chemicals (e.g. hydrogen peroxide H2O2) are used. ► Do not use oxidizing chemicals for cleaning. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Brush length:

Chapter Manual cleaning/disinfection and subsection:

■ FJ962R ■ FJ964P ■ FJ965R ■ FJ969R ■ FJ967R–FJ968R ■ FJ982R–FJ984R ■ FJ987R–FJ988R ■ FJ984R ■ FJ989R

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 "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

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.

3.5

Preparing for cleaning

► Disassemble the product immediately after use, as described in the respective instructions for use. ► Disassemble the product prior to cleaning, see Disassembly.

immersion disinfection

■ Disposable syringe 20 ml ■ Keep working ends open for cleaning.

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning. cloth or medical compressed air

Manual cleaning with ultrasound and immersion disinfection

■ BV739R ■ BW079R ■ FJ963R ■ FJ985R

■ Brush length: 30 mm/∅: 5,5 mm, e.g. TA006847

■ Disposable syringe 20 ml ■ Keep working ends open for

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

cleaning.

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

General information

■ Chapter Manual cleaning with

■ Drying phase: Use a lint-free

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

3.2

– 50 mm/∅ 10 mm; e.g. TA007747 for FJ962R, FJ982R, FJ967R – 50 mm/∅ 3,7 mm; e.g. GK694200 for FJ965R

■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ FJ968R ■ FJ982R–FJ984R ■ FJ987R–FJ988R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ BV739R ■ BW079R ■ FJ962R–FJ964R ■ FJ965R ■ FJ967R ■ FJ969R ■ FJ989R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FJ985R

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Brush length: – 50 mm/∅ 10 mm; e.g. TA007747 for FJ962R, FJ982R, FJ967R – 50 mm/∅ 3,7 mm; e.g. GK694200 for FJ965R – 50 mm/∅ 3.8 mm; e.g. TA011327 for FJ963R

■ Disposable syringe 20 ml ■ Place the product on a tray that

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

is suitable for cleaning (avoid rinsing blind spots).

■ Brush length: – 30 mm/∅ 5.5 mm; e.g. TA006847 for FJ969R, FJ989R – 50 mm/∅ 3.8 mm; e.g. TA011327 for FJ985R

■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

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

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.8

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.

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.

3.8.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

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).

II

Intermediate rinse

RT (cold)

1

-

D–W

-

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

III

Disinfection

RT (cold)

5

2

D–W

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

3.9.1 Phase

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

3.9

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh

Mechanical cleaning/disinfection

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfecting machine without ultrasound

– pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5% – pH = 11*

► 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 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.

3.8.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

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

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

DW: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.10 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.

3.10.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► 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.

3.10.2 Manual pre-cleaning with ultrasound and brush Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

► 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.

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► 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.

3.10.3 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

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Accessories / spare parts

Additional instruments are required for odontoid and C1-C2 screw fixation. The full range of the instruments can be found in brochures O23402 (ondontoic screw fixation) and O23502 (C1-C2 fixation).

– pH = 13 – <5 % anionic surfactant

■ working solution 0.5% – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

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

3.11 Inspection ► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.11.1 Visual inspection ► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.11.2 Functional test ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.12 Assembly 3.12.1 Assembling the screwdriver CAUTION The screwdriver will not function properly if the retaining tongues are bent or crimped! ► Do not bend or crimp the retaining tongues. ► Push the knurled nut 15 with the retaining tongues 14 onto the screwdriver shaft, so that the retaining

tongues 14 engage in the grooves of the screwdriver shaft. ► Screw the knurled nut 15 onto the threads, but do not tighten the nut down. ► Screw the screw sleeve 13 onto the tip of the screwdriver and tighten it down.

3.12.2 Fitting guide sleeve FJ962R ► Push locking shaft into the handle of the instrument, screw in clockwise and tighten.

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

3.14 Steam sterilization Note FJ962R, FJ967R, FJ969R, FJ989R: The product can be sterilized either in disassembled or in assembled condition. ► 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 fractional 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 ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

6.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA010746

2020-11

V6

Change No. 63662