AtRactor Atraumatic Retraction System Instructions for Use

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Aesculap AtRactor – Atraumatic Retraction System Key 1 Motor drive 2 Toothed rack 3 Blade arm 4 Swivel joint 5 Retractor arm 6 Lock positions 7 Blade 8 Push button 9 Crank 10 Stop 11 Rail 12 Recess 13 Adjustment pin 14 Engagement mechanism 15 Straining screw 16 Clamp 17 Grip padding 18 Threaded rod 19 Height adjustment screw 20 Disassembly pin 21 Lower tube 22 Insertion attachment 23 Retraction lever handle

Images A B C D E F G H I J

Atraumatic retractor FC501R Straight blades FC502R/FC503R/FC506R, Angular blades FC504R/FC505R/FC507R Atraumatic retractor with offset blades Atraumatic retractor with crank FC501800 and blades Atraumatic retractor with offset blades, for insertion, in closed position, in the sternum Table fixation for Mammaria retraction system FC512R Mammaria retraction system FC511R Atraumatic retractor with inserted retraction lever handle FC511800 Table fixation with attached Mammaria retraction system Atraumatic retractor with Mammaria retraction system

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 AtRactor – Atraumatic Retraction System. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

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: 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 AtRactor – Atraumatic Retraction System is used in median sternotomy to acquire access and enable the preparation of the mammary artery. It consists of an atraumatic retractor and a Mammaria retraction system to lift the retractor. For optimum adaptation to the patient, the blades of the retractor are movable on the blade arms and the blade arm is also swivel-mounted. This enables an atraumatic, V-shaped opening of the sternum. Suture holder FC135SU can be used in combination with the retractor.

2.1.2

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.

2.1.3

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.

2.2.2

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. ► Before lifting the retractor with the Mammaria retraction system: Open the retractor sufficiently.

3.

Validated reprocessing procedure

3.1

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. 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 B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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 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.

3.6

Disassembly

3.6.1

Disassembling the Mammaria retraction system for reprocessing

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

-

V

Drying

RT

-

-

-

-

► Remove the disassembly pins 20 and remove the threaded rod 18 completely from the lower tube 21, see Fig. G.

3.6.2

Disassembling the Mammaria retraction system from the retractor

► Lower the retraction system with the height adjustment screw 19, until the retraction lever handle 23 is approx-

imately horizontal, see Fig. H. ► Remove the retraction lever handle 23 from the grip padding 17 of the retraction system and then push it down-

wards from the retractor arm 5.

3.6.3

Disassembling the Mammaria retraction system from the table fixation

► Slide the retraction system on the rail 11 of the table fixation as far as the lateral stop 10 and remove it from

the rail 11 vertically in an upwards direction, see Fig. I. ► Undo the straining screw 15 of the table fixation and remove the table fixation from the operating table rail.

3.6.4

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

Disassembling the retractor

► Close the retractor using the crank 9 and remove it from the surgical opening, see Fig. D. ► Push the blades 7 downwards from the blade arms 3. ► Remove the crank 9 from the motor drive 1 by pressing the push button 8.

Note If the removable crank 9 is misplaced during the operation or is otherwise unusable, the retractor can be moved with a standard clamp. To do this insert the working ends of a clamp in the holes of the motor drive 1 and turn the motor drive 1.

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 plastic material and 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. ► 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

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

■ Straight blades FC502R/FC503R/FC506R

■ Angular blades FC504R/FC505R/FC507R

■ Table fixation FC512R

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

■ Chapter Manual cleaning with immersion disinfection

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

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

-

-

-

-

■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection

■ Atraumatic retractor FC501R ■ Mammaria retraction system FC511R

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

with 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 Mechanical alkaline cleaning and thermal disinfection

■ Straight blades

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

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline

FC502R/FC503R/FC506R

cleaning and thermal disinfecting

■ Angular blades FC504R/FC505R/FC507R

■ Table fixation FC512R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

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

■ Atraumatic retractor FC501R ■ Mammaria retraction system

is suitable for cleaning (avoid rinsing blind spots).

FC511R

■ Connect components with

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

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

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

■ Chapter Manual pre-cleaning

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.

with a brush

■ Chapter Mechanical alkaline

lumens and channels directly to the rinsing port of the injector carriage.

cleaning and thermal disinfecting

■ To flush the product: Use a flushing nozzle or flushing sleeve.

3.8

D–W: FD–W:

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.

infection procedure.

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.

3.10.2 Mechanical alkaline cleaning and thermal disinfecting

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

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:

Mechanical cleaning/disinfection

– pH = 13 – <5 % anionic surfactant

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.

3.9.1

Mechanical alkaline cleaning and thermal disinfecting

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

■ 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:

– 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

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

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.

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 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 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, 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 retractor ► Apply the crank 9 centrally on the lock position of the motor drive 1 and apply mild pressure so that it engages,

see Fig. D. ► Open the retractor with the crank 9 about a hand's width. ► Slide the two blades 7 onto the blade arms 3 of the retractor. One blade 7 will be on the left and one will be on

the right of the swivel joint 4. The blade surfaces should point inwards. ► To insert the retractor in the sternum, arrange the blades 7 on the blade arms 3 so that they are offset in relation

to the opposite blade, see Fig. C. Note The lock positions 6 on the blade arms 3 will help to position the blades, see Fig. A. ► Close the retractor as far as the stop, see Fig. E. ► After inserting the retractor in the sternum, open the retractor again slightly and move the blades 7 on the blade

arms 3 into the required lock position 6. Observe the following: – For an atraumatic V-shaped opening of the sternum, it is recommended to position the blades 7 at equal distances from the swivel joint 4, see Fig. D. – For optimum viewing conditions for preparing the mammary artery, the blades 7 must lie exactly under the sternum bone.

3.12.2 Mounting the table fixation Note The table fixation must be placed on the side of the patient on which the mammary artery is to be prepared. If both mammary arteries are to be prepared, one table fixation is needed on each side of the operating table. Note If the operating table is too narrow, we recommend using an additional rail. ► Attach the table fixation over the surgical drape on the operating table rail. Position it on the table rail so that

it is in line with in the middle of the patient's sternum. To mount the table fixation: – Open the straining screw 15 of the clamp 16, see Fig. F. – Mount the clamp 16 on the operating table rail and screw the straining screw 15 tight. ► When adjusting the operating table: – Retract the adjustment pins 13 of the table fixation. – Align the rail 11 of the table fixation horizontally. – Lock the table fixation in place by releasing the adjustment pins 13.

3.12.3 Mounting the retraction system ► Use the height adjustment screw 19 to lower the retraction system to the lowest height level, see Fig. G. ► Place the retraction system as vertically as possible on one of the stops 10 of the table fixation in the area of

the recess 12 with the insertion attachment 22 on the rail 11, and move it to the middle of the rail 11, see Fig. I. The retraction system is fixated form-fit in the central area between the recesses 12. ► Raise the retraction system with the height adjustment screw 19, so that the grip padding 17 is about a hand's width above the patient's body.

3.12.4 Mounting the Mammaria retraction system onto the retractor Note The retraction level handle 23 must be on the side of the retractor, which should be raised. ► Push the retraction lever handle 23 onto the retractor arm 5 from the free end of the retractor, so that the free

end of the retraction lever handle 23 is pointing towards the Mammaria retraction system, see Fig. H. ► Push on the retraction lever handle 23 until it is approximately in the area of the swivel joints 4 of the retractor. ► Lift the free end of the retraction lever handle 23 to lift the retractor unilaterally. ► Insert the end of the retraction lever handle 23 into the grip padding 17 of the retraction system, see Fig. J. ► Raise the retraction system using the height adjustment screw 19 as required, until the optimum viewing con-

ditions for preparing the mammary artery are obtained.

3.13 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 storage.

3.14 Steam sterilization 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). ► 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.

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

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.

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. TA014012

2020-12

V6

Change No. 63662