Retraction system Münster

en ®

Aesculap Retraction system Münster Legend 1 2 3 4 5 6 7 8 9

Sleeve Locking lever without anti-twist device Fixation clamp BV822R without anti-twist device Locking lever with anti-twist device Fixation clamp BV838R with anti-twist device Round notched rod Endpiece BV827R Octagonal notched rod Key PG290R

1.

About this document

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

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.

1.1

3.2

Scope

These instructions for use apply for the Retraction system Münster. 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

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".

The retraction system Münster is used in stomach and vascular surgery as well as gynecology.

3.3

2.1.2

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.

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.

3.4

Reusable products

Preparations at the place of use

No known contraindications.

► 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.

2.2

3.5

2.1.3

2.2.1

Contraindications

Safety information 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. It is possible to position several valves on the ring in almost any arrangement desired. The system is self-adjusting and used with octagonal and round notched rods. When using the octagonal notched rod 8, the surgeon adjusts and positions the system. The fixation clamp BV838R, when combined with the octagonal notched rod, prevents the valves twisting and being levered out. ► Steadily increase the application of force using the octagonal notched rod 8 and round notched rod 6 in 5 mm steps. This avoids the tissue being overextended. ► In order to reduce the force, activate the locking lever 2/4 of the fixation clamp 3/5, see Fig. 9.

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. ► Open up product with hinges.

3.6

Disassembly

► Unscrew the round notched rod 6, octagonal notched rod 8 and valves from one another.

Note The locking nut of the safety pin cannot be removed from the notched rod (loss prevention device). ► Pull the locking lever 2/4 from the fixation clamp 3/5. ► Remove the ring whilst leaving the sleeve 1 open, see Fig. 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.

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:

■ BV823R, BV825R-BV828R, BV833R-BV835R, BV839R, BV840R

■ 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.

■ Drying phase: Use a lint-free

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

-

-

-

-

cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection

■ BV814R, BV815R, BV817R, BV819R, BV821R, BV822R, BV837R, BV838R, BV849R

■ 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

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

■ BV823R

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

■ BV825R-BV828R, BV833R-

is suitable for cleaning (avoid rinsing blind spots).

BV835R, BV839R, BV840R

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

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

■ BV814R, BV815R, BV817R,

is suitable for cleaning (avoid rinsing blind spots).

BV819R, BV821R, BV822R, BV837R, BV838R, BV849R

3.8

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

■ Chapter Manual pre-cleaning with a brush

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

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

D–W: FD–W:

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

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 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.

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

-

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

III

Disinfection

RT (cold)

5

2

D–W

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

3.9

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.

Mechanical cleaning/disinfection

IV

Final rinse

RT (cold)

1

-

FD-W

-

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).

V

Drying

RT

-

-

-

-

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

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) 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. ► 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.

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: – 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

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

3.11 Inspection

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).

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

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

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

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

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

► 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*

RT (cold)

1

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

3.10.1 Manual pre-cleaning with a brush

II

3.11.1 Visual inspection

-

D–W

-

► 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 Ring/ring connecting rod ► Push the sleeve 1 back all the way. ► Insert the cone into the recess and lock by pushing the sleeve forward 1. ► Repeat this procedure for all of the adaption points, see Fig. 1.

3.12.2 Valve/octagonal notched rod/round notched rod/round notched rod with hinge/ octagonal notched rod with fixable hinge ► Select the notched rods in accordance with the required length. ► Take the valve that is to be inserted and screw it onto the notched rod, align it, and use the key 9 to tighten the

locking nut, see Fig. 6 and Fig. 7. The endpiece 7 can be screwed on if necessary when using the round notched rod 6. ► For the octagonal notched rod 8 with fixable hinge: Align the hinge and use the Allen key to moderately tighten the screw. Note Do not use the endpiece 7 in combination with the octagonal notched rod 8. ► For the round notched rod 6: Screw the endpiece BV827R 7 onto the notched rod, see Fig. 7

3.12.3 Fixation clamp/locking lever for the octagonal and round notched rod ► Push the locking lever 2/4 into the fixation clamp 3/5, see Fig. 2 and Fig. 3.

3.12.4 Octagonal notched rod/round notched rod/fixation clamp BV838R

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

WARNING Restricted stability and function! ► Do not insert any notched rods that are screwed together into the fixation clamps.

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

► Insert them notched rod in the direction of the arrow through the drilled hole in the fixation clamp 3/5, see Fig. 4

and Fig. 5. Any shrinking back is prevented by the ratchet of the locking lever 2/4.

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: – 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.

► In order to move the notched rod against the direction of the arrow, press on the locking lever 2/4.

The locking mechanism is released. BV838R: For the octagonal notched rod 8, a clip is provided to protect against distortion due to form locking, see Fig. 6. For the round notched rod 6, the anti-twist device folds backwards, see Fig. 7.

3.12.5 Fixation clamp/ring ► Unscrew the screw of the fixation clamp 3/5 until the fixation clamp 3/5 can be freely placed on the ring. ► Place the fixation clamp 3/5 with the inserted notched rod and installed valve (aligned towards the surgical field)

on the ring. ► Screw the fixation clamp 3/5 tight, see Fig. 6 and Fig. 7.

Note It is possible to change the position of the valve by loosening the locking nut, see Fig. 6 and Fig. 7. WARNING Restricted stability! ► Do not attach the fixation clamp in the area of the ring lock. Note Loosen and tighten the valve on the octagonal notched rod 8 using the locking nut in such a way that no forces are transferred to the fixation shank, and so that there is no risk of damaging the latter, i.e. when loosening and tightening the locking nut, the valve must be used as counterbearing (held in the hand). ► In order to enable better access to the surgical field, unscrew the projecting endpiece 7 after retraction. It is only

possible to unscrew the endpiece when the black marking on the endpiece 7 is visible outside the ring on the side of the fixation clamp 3/5 that is turned away from the surgical field, see Fig. 9.

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 ► 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. TA010185

2020-09

V6

Change No. 63346