Reusable trocar system 10 mm, 12 mm

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Aesculap Reusable trocar system 10 mm, 12 mm Legend 1 Trocar sleeve (with optional thread) 2 Insufflation valve (optional, open position) 2a Stopcock 3 Spring cap 4 Recess 5 Trocar obturator 6 Positioning lug 7a Sealing cap red (with valve converter) 7b Sealing cap yellow 8 Locking buttons 9 Reusable valve unit (10–12 mm with 5-mm valve converter) 10 Reusable valve unit (10–12 mm) 11 Disposable universal sealing element (5–12 mm) 12 Valve shell 13 Cross slit valve 14 Tab

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: Art. no.

Designation

EK024R to EK028R

Trocar sleeve

EK034R to EK038R

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 with visual control. ► Only combine Aesculap trocar components of the EK series with each other. ► Only combine trocar sleeves and trocar obturators with the same color code (diameter) and the same working

length. ► Observe handling instructions in the instrument-specific instructions for use.

2.3.3

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile products Art. no.

Designation

EK002SU

DISPOSABLE UNIVERSAL SEALING ELEMENT FOR 10/12MM TROCARS

EK159SU

DISPOSABLE DILATION TROCAR OBTURATOR 10/110MM

EK160SU

DISPOSABLE DILATION TROCAR OBTURATOR 10/150MM

EK169SU

DISPOSABLE DILATION TROCAR OBTURATOR 12/110MM

EK170SU

DISPOSABLE DILATION TROCAR OBTURATOR 12/150MM

The product is gamma-sterilized and supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. ► Do not reuse the product.

EK056R, EK057R, EK059R, EK060R, EK062R, EK063R, EK066R, EK067R, EK069R, EK070R, EK072R, EK073R

Trocar obturator

EK083P, EK086P

Valve unit

2.4

EK084P

Cross slot valve

EK085P

Sealing cap

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. ► Replace sealing element if necessary. ► To prevent damage to the sealing element, apply appropriate care when inserting any instruments. ► If possible, insert instruments in their closed position, straight and central through the sealing element.

The preparation of the product affects its functionality. Risk of injury, illness or death due to contamination and/or impaired functionality of the product. ► Do not reprocess the product.

EK087P

Reduction converter

EK088P

Valve shell

Application

► 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

The reusable trocar system of the EK series is available in the following variants: ■ Useful lengths: 110 mm, 150 mm ■ Diameter: 10 mm (green), 12 mm (yellow) For a complete overview of our trocar systems, please see the Endoscopy Online Catalog under www.endoscopycatalog.com Note The reusable trocar sleeves can be combined with either reusable or single-use trocar obturators and sealing elements.

2.2

Areas of use and limitations of use

2.2.1

Intended use

The reusable trocar system is used in operations in laparoscopic general surgery, gynecology and urology. It serves to create and maintain an approach to the operating field for instruments and endoscopes in laparoscopic operations. Endoscopic instruments of 5–10 mm diameter (10-mm trocar) and 5–12 mm diameter (12-mm trocar) can be inserted.

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.

WARNING Risk to patients due to inappropriate application! ► Prior to inserting the trocar into the patient, prepare an abdominal pneumoperitoneum, e.g. with a Veress needle. ► Apply skin incisions in order to avoid excessive application of force. ► Position trocars under intra-abdominal visual control. CAUTION Malfunction due to incompatible instruments! ► Check for mutual compatibility of the trocar system and instruments. To do this, carefully insert the instrument into the trocar and check for patency. ► Insert valve unit 9/10/11 into trocar sleeve 1, see Assembly. ► When using the trocar sleeve with the insufflation stopcock 2: Close stopcock 2a by turning it clockwise by 90°. ► For valve unit 9 with 5mm flap converter: Open sealing cap red 7a, see illustration, arrow B. ► Insert the trocar obturator 5 into the trocar sleeve 1. Place the positioning lug 6 in recess 4. ► Insert the trocar into the patient by alternating left/right rotating movements, applying even and controlled pres-

sure. ► For trocar sleeve 1 with thread: turn trocar sleeve clockwise until fully fixed in the thread. ► Retract trocar obturator 5.

Trocar sleeve 1 remains positioned in the patient. ► When connecting the inflation to the inflation stopcock 2: connect, start inflation and open stopcock 2a. ► Carry out intra-abdominal visual control. ► For valve unit 9 with 5mm flap converter: Click sealing cap red 7a into the sealing cap yellow 7b, see illustration,

arrow C. ► For using 10–mm and 12–mm instruments and valve unit 9 with 5-mm linked converter: Use the yellow sealing

cap 7b. ► After use, with trocar sleeve 1 with thread: turn trocar sleeve counterclockwise until the thread is fully released.

Note Use a reduction sleeve when inserting needles. Note Apply rotary movement to remove hook-shaped instruments. Note The valve unit can be removed from the trocar sleeve for retrieving larger portions of resected tissue. The depressurization caused by this action has to be compensated when re-installing the valve unit.

3.

Validated reprocessing procedure

2.3

Safety information

3.1

General safety information

2.3.1

Clinical user

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

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 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.

Validated procedure

Specific requirements

Reference

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.

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

■ Suitable cleaning brush, e.g.

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

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

3.3

Single-use products

Art. no.

Designation

EK002SU

DISPOSABLE UNIVERSAL SEALING ELEMENT FOR 10/12MM TROCARS

EK159SU

DISPOSABLE DILATION TROCAR OBTURATOR 10/110MM

EK160SU

DISPOSABLE DILATION TROCAR OBTURATOR 10/150MM

EK169SU

DISPOSABLE DILATION TROCAR OBTURATOR 12/110MM

EK170SU

DISPOSABLE DILATION TROCAR OBTURATOR 12/150MM

► Do not reuse the product.

The preparation of the product affects its functionality. Risk of injury, illness or death due to contamination and/or impaired functionality of the product. ► Do not reprocess the product.

3.4

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.

3.5

Preparing for cleaning

Disassembly

3.7.1

Trocars with insufflation valve

Reusable valve unit

► Press both locking buttons 8 on the valve shell 12 and remove valve unit 9/10 from the trocar sleeve 1. ► Valve unit 9: Open sealing cap at tab 14 and remove it upwards from valve shell 12. ► Valve unit 10: Remove sealing cap 7b at tab 14 upwards from valve shell 12. ► Remove cross slot valve 13 downwards and out of valve shell 12.

3.7.3

Single-use universal sealing element

► Press both locking buttons 8 at valve shell 12, remove single-use universal sealing element 11 from the trocar

and dispose of the used sealing element.

3.8

Cleaning/Disinfection

3.8.1

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! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush, e.g.

Chapter Manual cleaning/disinfection and subsection:

TA007747

■ 20 ml disposable syringe ■ Keep working ends open for 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

cleaning and thermal disinfecting

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning.

■ Place the product on the tray with all product links and joints open.

3.9

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.

3.9.1

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

-

-

-

-

D–W: FD–W:

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

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.

■ Chapter Manual cleaning with immersion disinfection

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.

3.10 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

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

-

cleaning.

■ When cleaning instruments

with a brush

■ Chapter Mechanical alkaline

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.

► Screw off spring cap 3. ► Remove stopcock 2a.

3.7.2

■ Chapter Manual pre-cleaning

infection procedure.

► Disassemble the product prior to cleaning, see Disassembly. ► For valve unit 9 with 5mm flap converter: Open sealing cap red 7a at the joint, see illustration, arrow B.

3.7

■ Single use syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

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.

3.6

TA007747

cloth or medical compressed air 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.

3.14 Steam sterilization Note Aesculap recommends using an Endo Rack for sterilization and storage of the product. Note The product can be sterilized either in disassembled or in assembled condition. CAUTION Damage or leaking of the cross slot valve caused by incorrect handling during sterilization! ► Sterilize trocar obturators separately (not in the trocar sleeve). ► Position the sealing cap with its joint in such a way that the joint is kept open. ► 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).

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

-

-

-

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.

3.11 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 contamination has been removed. In particular, pay attention to mating surfaces, hinges, shafts,

► 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.

3.15 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 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.

4.2

Accessories/Replacement Parts

Art. no.

Designation

EK083P

Reusable valve unit for 10-mm and 12-mm trocars with 5-mm linked converter (x1), complete (1 pc) consisting of:

EK084P EK087P EK088P

– Cross slit seal for 10-mm and 12-mm trocars, single (pack of 20 seals) – Flap converter, reduction from 10/12 mm to 5 mm (pack of 5) – Valve unit for 10-mm and 12-mm trocars, single (1 pc)

EK086P

Reusable valve unit for 10-mm and 12-mm trocars with sealing cap, complete (1 pc), consisting of:

EK084P EK085P EK088P

– Cross slit seal for 10-mm and 12-mm trocars, single (pack of 20 seals) – Sealing cap for 10-mm and 12-mm trocars, single (pack of 20 caps) – Valve unit for 10-mm and 12-mm trocars, single (1 pc)

EK002SU

Disposable universal sealing cap, complete (pack of 20)

recessed areas and drill grooves. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. corroded, loose, bent, broken, cracked, worn or severely scratched and frac-

tured 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.

3.11.2 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.

3.12 Assembly 3.12.1 Trocars with insufflation valve ► Install stopcock 2a in insufflation valve 2. ► Unscrew the spring cap 3.

3.12.2 Reusable valve unit ► Check seals for cracks and other damage; replace if necessary. ► Press sealing cap 7a or 7b downwards into valve shell 12. With this, position the link or tab in recess 4. ► Press cross slot valve 13 upward into valve shell 12. ► Insert valve unit 9 or 10 in trocar sleeve 1. ► Press on the middle of the sealing cap 7a/7b until both locking buttons 8 audibly click into the trocar sleeve 1.

When doing so, position the joint next to the valve unit 9 and the tab 14 next to the valve unit 10 in the recess 4.

3.12.3 Single-use universal sealing element ► Install single-use universal sealing element 11 in trocar sleeve 1. ► Press centrally on single-use universal sealing element 11 until both locking buttons 8 click into position.

3.13 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.

For a complete overview of trocar systems, see the Endoscopy Online Catalog at 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, ensure that the packaging prevents the product from causing injury. Note The user institution is obliged to reprocess the product before its disposal, see Validated cleaning and disinfection procedure. TA012756

2020-07

V6

Change No. 61676