Reusable reduction sleeves and suture material sleeves

en

2.4 ®

Aesculap Reusable reduction sleeves and suture material sleeves Legend 1 2 3 4 5

Reduction sleeve (5 mm to 3.5 mm) Suture material sleeve Recess Sealing cap Tab

1.

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. ► 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. CAUTION Malfunction due to incompatible instruments! ► To check the compatibility of the trocar system with instruments, carefully insert the instrument into the trocar sleeve and check for patency.

About this document

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

Note The sealing function of the suture material sleeves and the reduction sleeves can be ensured only with instruments inserted!

1.1

2.4.1

Scope

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

Designation

EK390R

Reduction sleeve 5 mm to 3.5 mm

EK391R

Suture material sleeve for 3.5 mm trocars

► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at

eifu.bbraun.com

1.2

Inserting a needle

Reduction sleeve ► Insert the needle holder into reduction sleeve 1 far enough that the end of the needle holder can be seen. ► Grasp the suture thread immediately behind the needle. ► Completely retract the working end of the needle holder with the needle into reduction sleeve 1. ► Insert reduction sleeve 1 in the trocar. ► Post application, distally remove the needle from reduction sleeve 1. Do not pull the needle through sealing cap 4.

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.

Suture material sleeve ► Insert suture material sleeve 2 into the trocar seal down to the positive stop. ► Insert the suture material through suture material sleeve 2.

2.4.2

Insert 3.5mm instruments into 5mm trocars

Reduction sleeve ► Insert reduction sleeve 1 in the trocar. ► Insert the instrument through reduction sleeve 1.

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

3.

Validated reprocessing procedure

3.1

General safety information

2.

Clinical use

2.1

Available sizes

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

Designation

Diameter

Sealing cap

Reduction sleeve

5 mm to 3.5 mm

blue

Suture material sleeve

3.5 mm

blue

Note For a complete overview of our trocar systems, see the Endoscopy Online Catalog at www.endoscopy-catalog.com

2.2

Areas of use and limitations of use

2.2.1

Intended use

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.

The reduction sleeves are used during operations in general laparoscopic surgery, pediatrics, gynecology and urology to prevent leaks when inserting 3.5mm diameter instruments into 5mm trocars and to insert needles or swabs safely through the trocar valve unit, for example. The suture material sleeves are used to introduce needles safely through the trocar valve unit.

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.

2.2.2

3.2

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.

2.3.2

Product-specific safety information

► To prevent damage at the working end: carefully insert the product through the working channel (e.g. trocar). ► Only use the product under vision. ► Only combine Aesculap trocar components of the EK line with each other. ► Observe handling instructions in the instrument-specific instructions for use.

2.3.3

Sterility

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

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

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

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 prior to cleaning, see Disassembly.

3.6

Disassembly

► Pull sealing cap 4 upward, grasping it at tab 5.

3.7

Cleaning/Disinfection

3.9

3.7.1

Product-specific safety information on the reprocessing method

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).

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.

Mechanical cleaning/disinfection with manual pre-cleaning

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

-

► 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

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush:

Chapter Manual cleaning/disinfection and subsection:

30 mm/∅: 4.5 mm, e.g. TA011944

■ Chapter Manual cleaning with

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

immersion disinfection

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

■ Cleaning brush:

► 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:

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).

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

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.

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

3.9.2

■ Use jetting lances or irrigation

Mechanical alkaline cleaning and thermal disinfecting

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

sleeves in the injector vehicle to rinse out the lumens/ducts.

3.8

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

Manual cleaning/disinfection

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:

► 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.

3.8.1

Manual cleaning with immersion disinfection

Phase

Step

– pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5% – pH = 11*

I

Disinfecting cleaning

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

-

-

-

-

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.

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-

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.

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

3.10.1 Visual inspection ► 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 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 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 ► Completely push the sealing cap 4 into the reduction sleeve 2 or suture material sleeve with the tab 5 in the

recess 3.

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 either in disassembled or in assembled condition. Note Sterilize the reduction sleeve separately (i.e. not inserted into trocar or valve unit). Note For sterilization and storage of the product, Aesculap recommends using the Endo Rack. ► 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 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

EK382P

Sealing cap 3.5mm, single (pack of 20)

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. TA013287

2020-07

V6

Change No. 61676