activ O frame system

en AESCULAP® activ O Frame system Legend A B C D E F G H I J

Connecting piece with quick-release coupling Coupling bar Coupling piece short Radiolucent valve Fixation screws Screwdriver for fixation screws Fastening clamp T-wrench UNITRAC universal holder Forceps for changing the blades

1.

About this document

2.2.2

Sterility

Non-sterile packaged products Art. no.

Designation

BV399R

Forceps for changing the blades

BV858R

Connecting piece with quick-release coupling

BV859R

Coupling piece short

BV860R

Coupling bar 150 mm

BV861R

Coupling bar 200 mm

BV862P

Radiolucent valve: Size S-green

BV863P

Radiolucent valve: Size M-yellow

BV864P

Radiolucent valve: Size L-blue

BV868R

Screwdriver for fixation screws

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

BV869R

Fastening clamp

1.1

BV899R

T-wrench

Scope

These instructions for use apply to the following products: ■ Instruments of the activ O frame system Note The applicable CE mark for the product can be seen on the label or packaging of the product. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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: 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 Aesculap activ O frame is a surgical approach and retraction system. It is used for a ventral, ventrolateral or lateral approach to the spine. With this system, valves can be placed at any position on the ring and fastened on the spine, using fixation screws. The frame can be fastened to the operating table (see instructions for use TA011611 or TA009150 respectively). In the latter configuration, fixation with fixation screws on the spine is not required.

2.1.2

Indications

The product is supplied non-sterile and intended to be used in sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile products Art. no.

Designation

BV865SU

Fixation screw: Size S-green

BV866SU

Fixation screw: Size M-yellow

BV867SU

Fixation screw: Size L-blue

The product has been sterilized by irradiation and is supplied in sterile packaging. The safe sterile provision of the product is only guaranteed if the sterile packaging is undamaged and unopened and the use-by date has not passed. ► Store products in their original packaging in a dust-protected, dry and temperature-controlled room. ► Protect products from direct sunlight. ► Remove products from their original protective packaging only just prior to application. ► Visually inspect the product packaging to ensure that the sterile barrier system is intact. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. The product is intended for single-use. ► Do not reuse the product. The processing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not process the product.

2.3

Application

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.

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.

2.1.3

2.3.1

Contraindications

No known 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.

Mounting the radiolucent valves

WARNING Injuries to nerve roots and spinal cord due to mismatch between fixation screw and valve sizes! ► Use the color-coded fixation screws matching the color of the valve. ► Screw in the fixation screw under X-ray monitoring. WARNING Injury to soft tissue parts or vessels, caused by fixation screws! ► Position the valve without a fixation screw. Only when the valve is correctly positioned, insert and tighten the fixation screw. CAUTION Breakage, deformation or loosening of the fixation screw due to manipulating the valve after insertion of the fixation screw, resulting in complication or prevention of fixation screw removal from the valve! ► Place the valve in the correct position before inserting the fixation screw. ► When using a valve with a fixation screw: Affix the valve to the associated frame using the coupling bar. CAUTION Valve breakage! ► Avoid knocks on the valve or on components connected to the valve. ► Do not impel the fixation screws with a mallet under any circumstances. ► Select a valve D of appropriate length (S, M or L) for the patients. ► Valve D can be fixed to the vertebral body with a fitting fixation screw E. Be careful to use a valve and

screw of the same size (see color code). ► Apply screwdriver F on the hexagon head of fixation screw E. ► Insert and tighten fixation screw E in valve D, see Fig. 1.

2.3.2

Loosening the fixation screw

► Apply screwdriver F on fixation screw E and unscrew counterclockwise. ► Remove screwdriver F with fixation screw E from the operating field.

Note The fixation screw E is fixed on the screwdriver F.

2.3.3

Adapting the coupling bars

WARNING Damage to soft tissue parts! Loss of approach due to incorrect tightening or mounting of the coupling bars! ► Tighten the nut of the coupling bar, then verify that the angular position cannot be moved anymore. ► Always engage the valve coupling until it clicks. ► Depending on application, mount coupling piece C or coupling bar B on radiolucent valve D.

Note Optionally, coupling bars B can be mounted at an offset angle of 90°. ► If necessary mount universal holder I on the respective coupling. ► To extent the construct, install connecting piece with quick-release coupling A on the respective coupling, see Fig. 2.

2.3.4

Adjusting the inclination angle of the coupling bars

Note Coupling bars B can be adjusted to an inclination of between 15° upwards and 90° downwards. ► To loosen the coupling lock, apply T-wrench H on hexagon 1 and untighten counterclockwise. ► Move T-wrench H to the required angle and tighten hexagon 1 turning the tool clockwise, see Fig. 3. Coupling bar B is locked again.

2.3.5

Releasing the quick-release coupling

► Grip the quick-release coupling 1 of the connecting piece A or the UNITRAC universal holder J on the han-

dle part and pull backwards, see Fig. 4. Note Optionally, optics holder RT081R can be fixed to UNITRAC universal holder J and connecting piece with quickrelease coupling A. ► Fasten connecting piece with quick-release coupling A on the frame, using fastening clamp G, and install optics holder RT081R (see instructions for use TA009907).

2.3.6

Uncoupling the radiolucent valve

Note Radiolucent valve D can be uncoupled in two different ways. ► Grasp the coupling and press with the thumb on pin 1 of valve D. - or ► Push forceps J with the jaw side 2 under the coupling and use the forceps bolt 3 to push them onto the pins 1 of the valve D, see Fig. 5.

2.3.7

Mounting the fastening clamp on the frame

WARNING Loss of approach due to incorrect mounting and closing of the fastening clamp! ► Firmly tighten the fastening nut. ► Always engage the coupling bars and the frame until they click.

3.2

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 precleaning 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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Single-use products

Art. no.

Designation

BV865SU

Fixation screw: Size S-green

BV866SU

Fixation screw: Size M-yellow

BV867SU

Fixation screw: Size L-blue

The product is intended for single-use. ► Do not reuse the product. The processing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not process the product.

3.4

Service life

Art. no.

Designation

BV399R

Forceps for changing the blades

BV858R

Connecting piece with quick-release coupling

BV859R

Coupling piece short

BV860R

Coupling bar 150 mm

BV861R

Coupling bar 200 mm

Fastening clamp G is fixed on frame 4. ► Click the coupling bar B or connecting piece with the quick-release coupling A into the jaw piece of the fasting clamp G and place it in the desired position, see Fig. 7. ► Tighten fastening nut1 until the clamp is fully closed. If necessary tighten further with T-wrench H, see Fig. 8.

BV862P

Radiolucent valve: Size S-green

BV863P

Radiolucent valve: Size M-yellow

BV864P

Radiolucent valve: Size L-blue

2.3.8

BV868R

Screwdriver for fixation screws

CAUTION Loss of the fastening nut and the upper clamping element caused by complete removal of the fastening nut! ► Only loosen the fastening nut by 2–3 turns. ► Loosen fastening nut 1 by 2–3 counterclockwise turns. ► Click the fasting clip G into the desired position onto the frame 4 (BV814R/BV815R), see Fig. 6.

Dismounting the fastening clamp from the frame

► Loosen fastening nut 1 by 2–3 counterclockwise turns, using T-wrench H if necessary. ► Unclick coupling bar B or connecting piece with quick-release coupling A from the jaw part of fastening

BV869R

Fastening clamp

clamp G. ► Slide off fastening clamp G from the frame by applying lateral pressure on the clamp, see Fig. 9.

BV899R

T-wrench

2.3.9

Disassembling/Assembling the fastening clamp

Disassembling ► Remove fastening nut 1 from threaded pin 3 by turning it counterclockwise. ► Remove jaw part 2, see Fig. 10. Assembling ► Put jaw part 2 with its hole over threaded pin 3. ► Screw on fastening nut 1 clockwise, with the hexagon facing upwards.

Influences of the processing using the validated procedure 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.

3.5

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for

example.

3.

Validated processing procedure

► 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.

3.1

General safety instructions

3.6

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 processing of products. Note Mechanical processing 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. Note Sterilization should always be favored over disinfection under all circumstances. Only if final sterilization is not possible should disinfection with a virucidal agent be preferred. Note Up-to-date information about processing and material compatibility can be found on the B. Braun eIFU site at eifu.bbraun.com The validated steam sterilization procedure was carried out in the AESCULAP sterile container system.

Preparing for cleaning

If applicable: ► Disassemble the product prior to cleaning.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the processing method

BV901R to BV904R: Danger to the patient! The product must not be manually processed. ► Process the product only in a mechanical washer/disinfector. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement).

3.7.2

Validated cleaning and disinfection procedure

Note Reprocessing may only take place in accordance with the following listed procedures in version V6. These are documented in the brochure “Validated Reprocessing Procedures” (AVA-V6) C63402. You will also find this brochure on the B. Braun eIFU site at eifu.bbraun.com Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection BV399R, BV842R, BV859R, BV862P to BV864P, BV868R, BV869R, BV899R, FK166R, RT069R, RT092R

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► When cleaning instruments with

Chapter Manual cleaning/disinfecting and subsection:

movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning. ► Drying phase: Use a lint-free cloth or medical compressed air.

with immersion disinfection

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► When cleaning instruments with

Chapter Manual cleaning/disinfecting and subsection:

movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning. ► Drying phase: Use a lint-free cloth or medical compressed air.

with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection BV399R, BV859R, BV868R, BV901R to BV904R, FK166R

► Place the product on a tray that is

Chapter Mechanical cleaning/disinfection and subsection:

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection BV842R, BV862P to BV864P, BV869R, BV899R, RT069R

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Place the product on a tray that is

suitable for cleaning (avoid rinsing blind spots). ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Place the product on the tray with all product links and joints open.

■ Chapter Manual pre-cleaning

Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection RT092R

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Place the product on a tray that is

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

Manual cleaning with ultrasound and immersion disinfection BV814R, BV815R, BV843R, BV858R, BV860R, BV861R, RT073R, RT081R

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection BV814R, BV815R, BV843R, BV858R, BV860R, BV861R, RT073R, RT081R

3.8

suitable for cleaning (avoid rinsing blind spots). ► Place the product on the tray with all product links and joints open.

■ Chapter Manual cleaning

■ Chapter Manual cleaning

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Chapter Manual pre-cleaning

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Place the product on a tray that is

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

with a brush

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfecting

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

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*

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

-

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfection procedure.

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

-

-

-

-

with a brush

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of

V

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.

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

suitable for cleaning (avoid rinsing blind spots). ► Place the product on the tray with all product links and joints open.

suitable for cleaning (avoid rinsing blind spots). ► Place the product on the tray with all product links and joints open.

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.

D–W: FD–W:

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

disinfection 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. 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.

3.9

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.9.1

Mechanical alkaline cleaning and thermal disinfecting

3.10.3 Mechanical alkaline cleaning and thermal disinfecting

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

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

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

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:

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

– pH ≈ 13 – < 5 % anionic surfactant

– pH = 13 – < 5 % anionic surfactant

■ working solution 0.5%

■ working solution 0.5%

– pH = 11*

– pH = 11*

III

Intermediate rinse

>10/50

1

FD-W

-

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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: B. Braun Helimatic Cleaner alcaline

D–W: FD–W:

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

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

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

3.10.4 Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with 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

I

II

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

Rinsing

RT (cold)

1

-

D–W

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: B. Braun Helimatic Cleaner alcaline

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

Neutral:

■ Concentrate: – pH neutral – < 5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate:

-

– pH = 9.5 – < 5 % anionic surfactant

■ 0.5 % solution

D–W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh

III

Intermediate rinse

>10/50

1

FD-W

-

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

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

disinfection 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.

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: B. Braun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

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

3.10.2 Manual pre-cleaning with ultrasound and brush

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

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

Rinsing

RT (cold)

1

-

D–W

-

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 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

Technical service. D–W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfection 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.

3.11.2 Functional test CAUTION Damage (metal cold welding/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: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products. ► Check that the product functions correctly. ► Check that all moving parts are working properly (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 Packaging ► 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 stor-

age.

3.13 Steam sterilization RT069R Note The product may only be sterilized in disassembled 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). ► Use validated sterilization process: – Disassemble the product – 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.

3.14 Storage ► Store sterile products in germ-proof packaging (sterile barrier system). Observe the information provided

by the manufacturer of the sterile barrier system in regards to storage.

4.

Technical service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. 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.

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. Note The user institution is obliged to process the product before its disposal, see Validated processing procedure. TA011942

2022-02

Change No. AE0061406