Reusable trocar system 5 mm

en

2.3.2 ®

Aesculap Reusable trocar system 5 mm 1 Trocar sleeve (with optional thread) 2 Insufflation valve (optional, open position) 2a Valve 3 Spring cap 4 Recess 5 Trocar obturator 6 Positioning lug 7 Single-use valve unit 8 Valve unit (reusable) 9 Sealing cap 10 Cross slit valve 11 Tab 12 Suture fixation (only for smooth trocar sleeves)

About this document

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

1.1

length. ► Use suture fixation 12 only with smooth trocar sleeve 1. ► Observe handling instructions in the instrument-specific instructions for use.

Legend

1.

Scope

These instructions for use apply for the following products: Item no.

Designation

EK010R to EK018R

Trocar sleeve

EK045R to EK053R

Trocar obturator

2.3.3

Valve unit

EK081P

Cross slot valve

EK082P

Sealing cap

EK097R

Suture fixation

► 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

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 Item no.

Designation

EK001SU

SINGLE-USE SEALING UNIT FOR 5MM TROCARS

EK148SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/60MM

EK149SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/100MM

EK150SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/150MM

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.

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.

2.4 EK080P

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

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. ► 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. 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 cannula. ► 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 7/8 into trocar sleeve 1, see Assembly. ► When using the trocar sleeve with an insufflation valve 2, close valve 2a by turning it 90° to the right. ► Insert the trocar mandrel 5 into the trocar 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.

The reusable trocar system of the EK series is available in the following variants: ■ Working lengths: – 60 mm – 110 mm – 150 mm ■ Diameter: 5 mm (red) For a complete overview of our trocar systems, please see the Endoscopy Online Catalog under www.endoscopycatalog.com

► For trocar sleeves 1 with threads: turn in a clockwise direction until the trocar is in the desired position. ► Retract trocar obturator 5.

2.2

Areas of use and limitations of use

2.2.1

Intended use

Note Apply rotary movement to remove hook-shaped instruments.

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 up to 5 mm diameter 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.

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.

Trocar sleeve 1 remains positioned in the patient. ► When using the suture fixation 12: Wind the suture around suture fixation 12 at least twice, into the slots. ► When connecting the inflation to the inflation valve 2: connect, start inflation and open valve 2a. ► Carry out intra-abdominal visual control. ► Post application, unwind the suture thread from the suture fixation 12. ► After use, with trocar sleeve 1 with thread: turn trocar sleeve counterclockwise until the thread is fully released.

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

3.1

General safety information

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

3.9

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

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

Art. no.

Designation

EK001SU

SINGLE-USE SEALING UNIT FOR 5MM TROCARS

EK148SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/60MM

EK149SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/100MM

EK150SU

SINGLE-USE DILATATION TROCAR OBTURATOR 5/150MM

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

infection procedure. ► 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

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

Preparing for cleaning

► Fixation screws which permanently connect the various components must not be disassembled. ► Disassemble the product prior to cleaning, see Disassembly. ► If there is a spacer with inflation valve 2: open valve 2a.

3.7

Disassembly

3.7.1

Trocars

► If there is a spacer with inflation valve 2: open valve 3. ► Remove valve 2a. ► If necessary, open the screw of the suture fixation 12 and slide off the suture fixation from the trocar sleeve 1.

3.7.2

Reusable valve unit

► Grasp tab 11 of valve unit 8 and extract the valve unit from trocar sleeve 1. ► For cleaning, extract cross slit valve 10 from sealing cap 9.

3.7.3

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.

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

Single-use valve unit

► Grasp tab 11 of single-use valve unit 7, extract the valve unit from trocar sleeve 1 and dispose of the valve unit.

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.

3.8

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! ► Following the manufacturer's instructions, use cleaning and disinfecting agents, – be approved for plastic material (thermoplastics, silicon) and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water

3.10.1 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

-

Validated procedure

Specific requirements

Reference

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

Manual cleaning with immersion disinfection

■ Cleaning brush e.g.,TA007747 ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

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

3.8.2

Validated cleaning and disinfection procedure

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

■ Cleaning brush e.g.,TA007747 ■ 20 ml disposable syringe ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ If the insufflation valve 2 is present: Connect the insufflation valve 2 or Luer valve directly to the special connector at the injector carriage.

■ Use jetting lances or irrigation sleeves in the injector vehicle to rinse out the lumens/ducts.

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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]

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.

3.11 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,

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 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.

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 ► If the insufflation valve 2 is present: Install valve 2a into the insufflation valve 2. ► Screw on spring cap 3. ► If necessary, slide suture fixation 12 onto trocar sleeve 1 and tighten the screw of suture fixation 12.

3.12.2 Valve unit ► With a reusable valve unit 8: extract cross slit valve 10 from sealing cap 9. ► Completely push the valve unit 7/8 into trocar sleeve 1 with tab 11 in recess 4.

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.

3.14 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Note Aesculap recommends using an Aesculap Endo Rack for sterilization and storage of the product. CAUTION Damage or leaking of the cross slit valve can be caused by incorrect handling during sterilization! ► Sterilize trocar obturators separately (not inserted in trocar sleeve or 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.

3.15 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

Item no.

Designation

EK001SU

Single-use valve unit 5 mm (pack of 20)

EK080P EK081P EK082P

Reusable valve unit 5 mm (pack of 20) Cross-slit valve 5 mm, single (pack of 20) Sealing cap 5 mm, single (pack of 20)

EK097R

Suture fixation (1 pc)

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-edged 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 reprocessing procedure. TA012921

2020-07

V6

Change No. 61676