AdTec – Needle holder and pressure plate applicator pliers

en AESCULAP® AdTec® Needle holder and pressure plate applicator pliers Legend 1 2 3 4

Jaw piece Lubrication points Luer lock connector for cleaning channel Screw handle

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 to AdTec® needle holders and the pressure plate application pliers. Note The applicable CE mark for the product can be seen on the label or packaging of the product. Note For the instructions for use and further information on B. Braun / AESCULAP products please refer to the B. Braun eIFU website 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.

2.4.2

Engaging the lock

► To lock handle 4 and jaw piece 1, fully compress the handle until the lock engages automatically with a

click. The instrument is locked now.

2.4.3

Releasing the lock

► Fully compress handle 4 until the lock is released automatically with a click.

Note After releasing the lock, the handle must be opened half-way at least before the lock can be engaged again.

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

No known contraindications. Applies to PL406R: Do not use with any indications other than named application areas.

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 precleaning 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".

2.3

Safety information

3.3

2.3.1

Clinical user

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.

2.

Clinical use

2.1

Available sizes

The suppliable AdTec® needle holders are described at www.endoscopy-catalog.com

2.2

Areas of use and limitations of use

2.2.1

Intended use

AdTec® needle holders are used for grasping and suturing in laparoscopic operations using trocars. The applier forceps PL406R is used for fixating the counter-pressure plate of a circular stapler.

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

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.

3.4

Reusable products

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

► Open up instruments with hinges. ► Remove the sealing cap from the Luer lock connector.

3.6

Cleaning/Disinfection

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.

3.6.1

Product-specific safety information on the reprocessing method

2.3.2

3.6.2

Product

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. ► Improper loading (lateral forces, bending, torsion, etc.) should be avoided. ► Clamp and affix only needles in the jaw parts using needle holders.

2.3.3

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.

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ Single use syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable

Chapter Manual cleaning/disinfection and subsection:

Sterility

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

2.4

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.

2.4.1

Closing the jaw piece

► To close jaw piece 1 and grasp objects without engaging the lock on handle 4, slightly compress the han-

dle.

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

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ 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.

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

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

■ Chapter Manual precleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.7

Manual cleaning/disinfection

3.8.2

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

the disinfecting solution.

Mechanical alkaline cleaning and thermal disinfecting

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

3.7.1

Manual cleaning with ultrasound and immersion disinfection

I

Prerinse

<25/77

3

D–W

-

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

III

RT (cold)

Disinfection

1

RT (cold)

5

-

D–W

2

-

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

■ 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:

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

disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

3.8

– pH ~ 13 – <5 % anionic surfactant

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.

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.

3.9

Inspection

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

3.9.1

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 products with long, slim shapes (in particular rotating instruments) for deformities. ► 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.

3.9.2

Functional test

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) at the marked points 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). ► Prior to function checks, lubricate both locking parts at the labeled points with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization:JG600 STERILIT® I oil spray or JG598 STERILIT® I drip). ► 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.

3.10 Packaging ► 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 stor-

age.

3.11 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces

3.8.1

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

-

(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.

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

area. 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

disinfection 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.

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

EJ751251

Sealing cap for Luer Lock connector (pack of 20)

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. TA011172

2022-06

Change No. AE0061781