DS clip removal forceps

en

2.4.2

Aesculap DS clip removal forceps

2.5

1 DS clip removal forceps 2 Jaws with teeth 3 Clip guide 4 Clip guide stop (clip ejector) 5 Retaining lug for clip guide 6 Clip guide stop (clip receiver) 7 Clip stop in jaws 8 Clip ejection window 9 Screw handle 10 Color coding (black: double bridge clip system; second color: clip size) 11 DS clip (model with latch) 12 Proximal end/bend 13 Latch 14 Clip bracket 15 Receptacle/hollow organ

WARNING Risk of injury when using the product outside the field of view! ► Apply the product only under visual control. WARNING Risk of injury due to electric shock! The handle of the DS clip removal forceps is not insulated. ► Do not apply any current to the DS clip removal forceps. CAUTION Damage to the trocar! ► Carefully feed the DS clip removal forceps with the jaws closed straight through the center of the trocar.

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 DS clip removal forceps. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

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.

Legend

1.

Sterility

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

®

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:

Note The DS clip removal forceps must be inserted on the same axis as that on which the clip was placed. To remove a placed clip, the clip's distal tip must be exposed. ► Push the clip guide 3 of the DS clip removal forceps 1 as far as the proximal stop of the clip guide 6. When doing

so, hold the clip guide on the labeled point on the narrow side, see Fig. A. The DS clip removal forceps are ready for use. ► Push on handle 9 until the jaws with teeth 2 touch. ► Carefully feed the DS clip removal forceps into the corresponding trocar with the jaws 2 closed, see Fig. B. ► In order to open the jaws 2, open handle 9 as far as it will go, see Fig. C. ► Guide the DS clip removal forceps, coming from the proximal end 12, over the DS clip 11, see Fig. D. When doing so, ensure that the DS clip is positioned fully in the jaws and does not protrude from the sides. ► Carefully push the DS clip removal forceps forward until DS clip 11 is positioned on the clip stop in jaw 7, see Fig. E.

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

Note When pushing on the handle 9, there must be no counteracting force applied.

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

► To close the jaws, push on handle 9 until the jaws with teeth 2 touch. ► Ensure that the DS clip is located between the clip guide 3 and behind the touching jaw parts with teeth 2.

2.

Clinical use

2.1

Available sizes

Note If the desired starting position is not achieved, then the DS clip removal forceps must be carefully removed and the DS clip has to be grasped again.

Art. no.

Designation

Color code

PL816R

Clip removal forceps for DS clips MEDIUM ∅ 10/310 mm

light blue

PL817R

Clip removal forceps for DS clips MEDIUM-LARGE ∅ 10/310 mm

green

PL818R

Clip removal forceps for DS clips LARGE ∅ 12/310 mm

orange

2.2

Areas of use and limitations of use

2.2.1

Intended use

DS clip removal forceps are used to remove DS clips placed during the same operation from a receptacle and/or hollow organ in a controlled manner and remove them from the site. DS clips with latch and DS clips without latch can be removed. The DS clip removal forceps can be used both for open surgery and laparoscopy.

2.2.2

Contraindications

Do not use in any cases that are not listed under Indications, see Indications.

2.3

Risks, adverse effects and interactions

The following possible undesired effects or interactions currently know to the manufacturer are referenced within the framework of the legal information reporting requirement. These are procedure-specific, not product-specific, and include infections or damage to treated or neighboring tissue structures.

2.4 Safety information ■ General risk factors associated with surgical procedures are not described in this documentation. ■ Aesculap is not responsible for any complications arising from, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis.

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques.

2.4.1

direction of the arrow, see Fig. G. The jaws 2 hold the DS clip in the jaws. ► Push on handle 9 until the jaws with teeth 2 touch, see Fig. H. ► Pull the DS clip removal forceps 1 through the trocar out of the body in this position. ► Push the clip guide 3 in a suitable location (e.g. instrument table) in a distal direction as far as the stop of the clip guide 4, see Fig. I. ► Rotate the DS clip removal forceps such that clip ejection window 8 is parallel to the table's surface. ► Whilst continually monitoring the clip ejector window 8 and the DS clip 11, repeatedly open and close the handle 9 until the DS clip 11 slides through the clip ejector window 8 out of the jaw parts. Note If the DS clip does not slide out of the jaws on its own, then the DS clip can also be removed using tweezers. ► Push the clip guide 3 of the DS clip removal forceps 1 as far as the proximal stop of the clip guide 6. When doing

so, hold the clip guide on the labeled point on the narrow side, Fig. A. The DS clip removal forceps are ready to use for the next clip.

Indications

DS clips of the following sizes can be removed with the DS clip removal forceps, see Available sizes: ■ MEDIUM ■ MEDIUM-LARGE (with and without latch) ■ LARGE (with and without latch)

2.2.3

► Close the handle 9 as far as it will go, see Fig. F. ► Carefully pull the DS clip removal forceps 1 with the handle closed from the receptacle/hollow organ 15 in the

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.

3.

Validated reprocessing procedure

3.1

General safety instructions

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

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.ak-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 opportunity to recognize a product that 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

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

► Use suitable cleaning/disinfecting agents if the product is disposed of 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

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

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

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.8.1

Manual pre-cleaning with a brush

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

Rinsing

RT (cold)

1

-

D–W

-

infection procedure.

cloth or medical compressed air

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

■ Connect components with

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-

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

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).

Validated cleaning and disinfection procedure

Validated procedure

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline

lumens and channels directly to the rinsing port of the injector carriage.

cleaning and thermal disinfecting

■ To flush the product: Use a

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.

3.8.2

flushing nozzle or flushing sleeve.

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:

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.

3.7.1

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

I

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.

3.8

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 example, on aluminum, plastic materials, 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.

3.7

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 V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

► Remove the sealing cap from the Luer lock connector. ► Remove the star wheel.

3.6.2

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.

Ultrasonic cleaning

T [°C/°F] RT (cold)

t [min] >15

Conc. [%] 2

Water quality D–W

– pH = 13 – <5 % anionic surfactant

■ working solution 0.5%

Chemical

– pH = 11*

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

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

Drying

-

-

-

According to the program for cleaning and disinfection device

II

Intermediate rinse

RT (cold)

1

-

D–W

-

V

III

Disinfection

RT (cold)

5

2

D–W

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

D–W: FD–W:

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► 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 ► 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.

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 soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or 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 product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► 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) 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). ► 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 storage.

3.11 Steam sterilization ► 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.

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

4.

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.

5.

Accessories / spare parts

Information about accessories/spare parts can be found in the following instructions for use: ■ TA013285 – Laparoscopic DS clip applier forceps and DS titanium ligature clips ■ TA013409 – DS clip applier forceps for open surgery and DS titanium ligature clips

6.

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 due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA013510

2020-08

V6

Change No. 62178