Reusable trocar system 3.5 mm

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Aesculap Reusable trocar system 3.5 mm Legend 1 Trocar sleeve 2 Insufflation valve (optional, open position) 2a Stopcock 3 Spring cap 4 Recess 5 Trocar obturator 6 Positioning lug 7 Valve unit (reusable) 8 Sealing cap 9 Cross slit valve 10 Tab 11 Suture fixation (only for trocar sleeves without insufflation)

1.

About this document

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

1.1

Scope

These instructions for use apply for the following products:

2.3

Safety information

2.3.1

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.

2.3.2

Product specific safety information

► Only use the product under visual control. ► Only combine Aesculap trocar components of the EK line with each other. ► Only combine trocar sleeves and trocar obturators having the same color codes (diameters) and the same working

lengths. Art. no.

Designation

EK310R

Trocar sleeve 3.5/60 mm, smooth with stopcock

EK311R

Trocar sleeve 3.5/60 mm, smooth without stopcock

EK314R

Trocar sleeve 3.5/110 mm, smooth with stopcock

EK315R

Trocar sleeve 3.5/110 mm, smooth without stopcock

► Only use suture fixation 11 on trocar sleeves without an insufflation valve. ► Observe handling instructions in the instrument specific instructions for use.

2.3.3

2.4 EK345R

Conical pointed trocar obturator, 3.5/60 mm

EK346R

Conical pointed trocar obturator, 3.5/110 mm

EK348R

Conical blunt trocar obturator, 3.5/60 mm

EK349R

Conical blunt trocar obturator, 3.5/110 mm

EK355R

Conical pointed trocar obturator, 3.5/60 mm

EK356R

Conical pointed trocar obturator, 3.5/110 mm

EK358R

Conical blunt trocar obturator, 3.5/60 mm

EK359R

Conical blunt trocar obturator, 3.5/110 mm

EK380P

Valve unit for 3.5 mm trocar

EK381P

Cross slit valve for 3.5 mm trocar

EK382P

Sealing cap for 3.5 mm trocar

EK397R

Suture fixation for 3.5 mm trocar

► For article specific instructions for use and material compatibility and lifetime information, 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

Available sizes

Sterility

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

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. ► If necessary, replace the sealing element. ► To prevent damage to the sealing element, apply appropriate care when inserting any instruments. ► If possible, insert instruments closed, straight and centrally through the sealing element. WARNING Any inappropriate use may result in danger to patients! ► Prior to inserting the trocar into the patient, prepare an abdominal pneumoperitoneum, e.g. using a Veress needle. ► Apply skin incisions to avoid any excessive application of force. ► For further trocar placement, perform visual intra-abdominal checks. CAUTION Incompatible instruments may result in malfunctions! ► Check for mutual compatibility of the trocar system and instruments. Carefully insert the instrument into the trocar and check for patency. Note When using the trocar sleeve with insufflation cock, the trocar obturator bearing the cock icon on its head must be used. ► Insert valve unit 7 into trocar sleeve 1, see Assembly. ► When using the trocar sleeve 1 with insufflation valve 2: Close stopcock 2a by turning it clockwise by 90°. ► Insert trocar obturator 5 into trocar sleeve 1. Position the positioning lug 6 in recess 4. ► Insert the trocar into the patient applying alternating left/right rotary movements and even and controlled pres-

sure. ► Retract trocar obturator 5.

Trocar sleeve 1 shall remain in position in the patient. ► When using suture fixation 11: Wind the suture around the suture fixation11 into the slots at least twice. ► If the insufflation is connected to the insufflation valve 2: Connect the insufflation device, start the device, and

open stopcock 2a. ► Perform intra-abdominal visual control. ► Post application, remove the suture thread from the suture fixation 11.

Note Apply rotary motion in removing hook-shaped instruments.

The reusable RBC trocar system is available in the versions listed below: ■ Working lengths: – 60 mm – 110 mm ■ Diameter: 3.5 mm (blue) The full overview over the trocar systems is described in the online endoscopy catalog www.endoscopy-catalog.com

Note The valve unit can be removed from the trocar sleeve for retrieving larger portions of resected tissue. The resulting gas loss must be compensated after the valve unit is reinstalled.

2.2

Areas of use and limitations of use

2.2.1

Intended use

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

The reusable trocar system is used in general laparoscopic surgery and surgical interventions in pediatrics, gynecology and urology. It is used to prepare and maintain access to the operating field for instruments and endoscopes. Endoscopic instruments of up to a diameter of 3.5 mm can be inserted through the trocars.

2.2.2

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.

2.2.3

Contraindications

► Do not use if laparoscopic operating techniques are contraindicated.

3.

Validated reprocessing procedure

3.1

General safety information

Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this.

3.8

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

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.

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.

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

3.2

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

-

-

-

-

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

3.3

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

► Do not disassemble anchoring screws/bolts that permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly. ► If there is an insufflation valve 2: Open stopcock 2a.

3.6

Disassembly

3.6.1

Trocars

► In case there is an insufflation valve 2: Unscrew spring cap 3. ► Remove stopcock 2a. ► If necessary, open the suture fixation screw 11 and slide the suture fixation from the trocar sleeve 1.

3.6.2

Valve unit

► Pull valve unit 7 using lug 10 from the trocar sleeve 1. ► Pull cross slit valve 9 from the sealing cap 8 for cleaning.

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. ► For wet disposal, use suitable cleaning agents/disinfectants. To prevent foam from forming and reduced effec-

tiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly under running water

3.7.2

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

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 option to determine if a product is no longer functional, see Inspection.

3.4

D–W: FD–W:

Validated cleaning and disinfection procedure

Validated procedure Manual cleaning with immersion disinfection

Specific requirements

■ Length of brush head: 30 mm/∅: 4.5 mm, e.g. TA011944

■ Single use syringe 20 ml ■ Drying phase: Use a lint-free

Reference

■ Length of brush head: 30 mm/∅: 4.5 mm, e.g. TA011944

■ Single use 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.

■ To flush the lumens/channels: Use flush lances or flush sleeves in the injector cart.

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.

3.9

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.

3.9.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with immersion disinfection

cloth or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

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

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

■ Chapter Manual pre-cleaning

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

with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

► 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.

3.9.2

Mechanical alkaline cleaning and thermal disinfecting

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

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical

3

D–W

-

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

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: FD–W:

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

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

3.10.1 Visual inspection ► Make sure all contamination has been removed. In particular, pay attention for instance to mating surfaces,

hinges, cocks/valves, shafts, recessed areas and drilled grooves. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check product for damage, e.g. corroded, loose, bent, broken, cracked, worn, heavily scratched or missing parts. ► 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 Tech-

nical service.

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

3.11 Assembly 3.11.1 Trocars ► In case there is an insufflation valve 2: Insert stopcock 2a in the insufflation valve 2. ► Screw spring cap 3 on. ► If necessary, slide suture fixation 11 onto the trocar sleeve 1 and tighten the suture fixation screw 11.

3.11.2 Valve unit ► Engage the cross slit valve 9 in the seal cap 8. ► Fully press valve unit 7 into the trocar sleeve 1 with lug 10 in the recess 4.

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

3.13 Steam sterilization Note The product can be sterilized in both a disassembled and an assembled state. Note Sterilize the trocar obturator separately (i.e. not inserted into the trocar or valve unit). Note Aesculap recommends using the Endo Rack for sterilization and storage of the product. CAUTION Any incorrect handling during sterilization may result in damage or leakage of the cross slit valve! ► Sterilize the trocar obturators separately, making sure that they are not inserted in the trocar sleeve or the valve unit. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

opening any valves and faucets). ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Maintenance and Service

4.1

Technical service

CAUTION Modifications to medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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.

4.2

Accessories/spare parts

Art. no.

Name

EK380P

Reusable valve unit, 3.5 mm, complete set (pack of 20), consisting of:

■ EK381P ■ EK382P

■ cross slit valve 3.5 mm alone (pack of 20) ■ sealing cap 3.5 mm (pack of 20)

EK397R

Suture fixation (1 unit)

Full overview over the trocar systems: cf. online endoscopy catalog www.endoscopy-catalog.com

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 from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA013286

2020-09

V6

Change No. 61676