Frankfurt retraction system

en

2.3 ®

Aesculap Frankfurt retraction system Legend 1 Goiter frame, complete 2 Cephalic frame 3 Threaded bolts 4 Locking screws 5 Gearings 6 Right thoracic frame 7 Sleeve 8 Left thoracic frame 9 Cylinder 10 Recess 11 Fixation clamp, complete 12 Wing nut 13 Valve clamp 14 Ratchet lever 15 Frame clamp 16 Valve, complete 17 Notched rod 18 Valve blade 19 Münster holding arm 20 Pediatric frame 21 Münster support arm adapter

1.

About this document

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 damage to the fixation clamp! If the wing nut is rotated when the fixation clamp is not seated on the goiter/pediatric frame, the material will be subjected to a great deal of stress! ► Make certain not to rotate the wing nut when the fixation clamp is not seated on the goiter/pediatric frame. Note To avoid pressure points from the goiter frame in the chest and shoulder regions, a suitable material, e.g. surgical drape or similar, should be laid underneath it.

2.3.1

Adjusting the cephalic frame

► Unscrew the locking screws 4 on the cephalic frame as far as they will go. ► Place the cephalic frame 2 in the desired position. ► Tighten the locking screws 4.

2.3.2

Sliding the valve and fixation clamp assembly onto the goiter/pediatric frame

► Loosen wing nut 12 and slide on valve 16 with fixation clamp 11.

2.3.3

Adjusting valve retraction force

► To increase valve 16 retraction force: Slide notched rod 17 in the direction of the arrow. To avoid overstraining

tissues, retraction force is increased continuously in 4 mm increments. ► To reduce valve 16 retraction force: Activate ratchet lever 14 on the fixation clamp and push notched rod 17 in

the opposite direction of the arrow.

2.3.4

Using the Münster support arm adapter to support the pediatric frame

► If necessary, mount the Münster support arm adapter, see Assembly.

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

3.

Validated reprocessing procedure

1.1

3.1

General safety instructions

Scope

These instructions for use apply for the Frankfurt 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: 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 Frankfurt retraction system is used to extend the operative access in goiter and abdominal pediatric surgery, in combination with the instruments intended for this purpose.

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.

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. ► Open up product with hinges.

3.6

Disassembly

3.6.1

Removing the valve 16 from the fixation clamp 11

► Activate the ratchet lever 14 and slide the notched rod 17 of the valve 16 through the valve clamp 13 in the

opposite direction of the arrow and out of the fixation clamp 11.

3.6.2

Removing the fixation clamp 11 from the goiter/pediatric frame

► Unscrew the wing nut 12 of the fixation clamp 11 as far as it will go. ► Slightly tilt the fixation clamp 11 on the goiter/pediatric frame and then remove it.

3.6.3

Disassembling the goiter frame

► Unscrew the locking screws 4 on the cephalic frame 2 as far as they will go. ► Remove the cephalic frame 2. ► Slide the sheath 7 on the right thoracic frame 6 back as far as it will go. ► Remove the right thoracic frame 6 from the left thoracic frame 8.

3.6.4

Dismantling the adapter of the Münster holding arm 21 that supports the pediatric frame

► Open the jaws of the Münster holding arm 19. ► Remove the pediatric frame 20 from the jaws of the Münster support arm. ► Push the adapter 21 off the Münster holding arm 19.

3.9

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:

■ Retractors ■ Pediatric frame ■ Fixation clamp ■ Adapter for table fixation ■ Goiter frame

cloth or medical compressed air

is suitable for cleaning (avoid rinsing blind spots).

■ Retractors ■ Pediatric frame ■ Adapter for table fixation ■ Goiter frame

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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.

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

■ Fixation clamp

is suitable for cleaning (avoid rinsing blind spots).

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.8

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

immersion disinfection

■ Drying phase: Use a lint-free ■ Place the product on a tray that

Mechanical cleaning/disinfection

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).

■ Chapter Manual cleaning with

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

Mechanical alkaline cleaning and thermal disinfection

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

Manual cleaning/disinfection

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

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

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

3.8.1

Manual cleaning with immersion disinfection

II

Rinsing

RT (cold)

1

-

D–W

-

Phase

Step

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

infecting solution.

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

-

-

-

-

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. 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.

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 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.

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

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.

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.

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.

3.11.2 Functional test

5.

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).

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

► 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 goiter frame ► Slide the sheath 7 on the right thoracic frame 6 back as far as it will go. ► Introduce the cylinder 9 on the right thoracic frame 6 into the recess 10 of the left thoracic frame 8. ► Slide the sheath 7 over the joint to lock in place. ► Unscrew the locking screws 4 on the cephalic frame 2 as far as they will go.

Note Make sure that the pairing code on the gearings 5 corresponds. ► Slide threaded bolts 3 on the cephalic frame 2 into the slots located in the gearings 5 on the right thoracic

frame 6 and left thoracic frame 8. ► Adjust the goiter frame 1 and tighten the locking screws 4.

3.12.2 Tightening the valve in the fixation clamp ► Slide the notched rod 17 in the direction of the arrow through the valve clamp 13 of the fixation clamp 11. The

ratchet lever 14 engages, preventing the notched rod from slipping backwards. ► To move the notched rod 17 in the opposite direction of the arrow: Press ratchet lever 14. The ratchet lever can

now be moved and the notched rod can be pushed.

3.12.3 Fixing the blade and fixation clamp assembly on the goiter/pediatric frame Note As many blades as desired can be placed on the goiter/pediatric frame. The system is self-adjusting when in use. CAUTION The functionality of the retraction system will be impaired and its stability inadequate for goiter surgery if the fixation clamp is not properly attached! ► Do not position the fixation clamp in the area near to the sheath 7. WARNING Risk of damage to the fixation clamp if the pediatric/goiter frame is not seated in the frame clamp 15! ► Before tightening the wing nut, make certain that the pediatric/goiter frame is seated in the frame clamp. ► Unscrew the wing nut 12 as far as it will go. ► Align the fixation clamp 11 to the operating field and click it onto the goiter frame 1 or pediatric frame 20 from

outside so that the frame is seated in the frame clamp 15. ► Tighten the wing nut 12 until the fixation clamp 11 is seated securely on the goiter frame 1 or pediatric

frame 20.

3.12.4 Mounting the adapter for the Münster holding arm 21 to support the pediatric frame ► Push the adapter 21 onto the Münster holding arm. ► Insert the pediatric frame 20 into the jaws of the Münster holding arm 19. ► Close the jaws.

3.13 Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► Close the locks so that the jaw tips just touch each other. ► 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 3.14.1 Goiter frame BW080R Note 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 fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

3.14.2 Retractors, pediatric frame and fixation clamp ► 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 fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer: ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

Disposal

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. TA010289

2020-09

V6

Change No. 63348