Laparoscopic DS clip applier forceps and DS titanium ligature clips

2.2.2

en

DS titanium ligature clips

AESCULAP Laparoscopic DS clip applier forceps and DS titanium ligature clips

Art. no.

Designation

Color code

PL450SU

DS clip magazine SMALL (15 individually and sterile packed magazines with 6 DS clips)

yellow

Legend

PL452SU

DS clip cassette SMALL multipack (6 individually and sterile packed magazines with 24 DS clips)

yellow

PL453SU

DS clip magazine SMALL-MEDIUM (15 individually and sterile packed magazines with 6 DS clips)

purple

PL459SU

DS clip magazine MEDIUM (15 individually and sterile packed magazines with 6 DS clips)

light blue

PL462SU

DS clip magazine MEDIUM-LARGE (15 individually and sterile packed magazines with 6 DS clips)

green

PL465SU

DS clip cassette MEDIUM-LARGE with notch (15 individually and sterile packed magazines with 6 DS clips)

green

PL468SU

DS clip magazine LARGE (12 individually and sterile packed magazines with 6 DS clips)

orange

PL471SU

DS clip cassette LARGE with notch (12 individually and sterile packed magazines with 6 DS clips)

orange

PL475SU

DS clip cassette X-LARGE with notch (12 individually and sterile packed magazines with 4 DS clips)

light grey

®

1 Jaws 2 Guiding ridges 3 Lubrication points 4 Sealing cap for Luer lock irrigation connector 5 Luer lock connection for cleaning the application forceps 6 Screw handle 7 Color coding clip applier forceps (black: dual shank clip system; second color: clip size) 8 Clip magazine 9 Labeling of the position of the tooth (labeling only for products with tooth) 10 DS clip 11 Adhesive strips 12 Slot (in DS clip) 13 Tooth 14 Clip size labeling

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 laparoscopic DS clip applier forceps and DS titanium ligature clips. Note The applicable CE mark for the product can be seen on the label or packaging of the product.

2.3

Areas of use and limitations of use

2.3.1

Intended use

► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

The laparoscopic DS clip applier forceps and DS titanium ligature clips are used for the ligating of vessels and hollow organs and for marking anatomical structures.

eIFU at eifu.bbraun.com

1.2

2.3.2

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: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result.

DS appendectomy clip (clip size X-LARGE) ■ Removal of the appendix and additionally the A. Appendicularis as applicable

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.

2.1 DS titanium ligature clips material ■ Pure titanium acc. to DIN EN ISO 5832-2 ■ Not transparent to X-rays Available sizes

2.2.1

Laparoscopic DS clip applier forceps

Note Ligature clips are intended for use on vessels or tissue structures (such as bile duct, appendix), for which surgical ligature clips are considered the best tools. The size, type and material of the clip are selected by the surgeon, based on his experience, estimation and requirement.

2.3.3

Absolute contraindications

DS titanium ligature clips (clip sizes SMALL to LARGE) and DS appendectomy clip (clip size X-LARGE) Do not use: ■ on the central circulatory system ■ on the central nervous system ■ in case of foreign-body sensitivity for titanium ■ for contraceptive procedures such as tubal occlusion, vasectomy ■ for closure of the A./V. renalis during living kidney donation

Clinical use

2.2

Indications

DS titanium ligature clips (clip sizes SMALL to LARGE) ■ Ligation of vessels and hollow organs ■ Marking of anatomic structures for radiological detection

■ DS appendectomy clip only: with highly inflammatory appendix with inclusion of the appendix base

Art. no.

Designation

Color code

2.3.4

PL801R

Laparoscopic DS clip applier forceps for DS clips SMALL ∅5.5/310 mm

yellow

Relative contraindications include, but are not limited to, medical and/or surgical conditions that could prevent the success of the implantation, e.g. disorders of the connective tissue (Marfan syndrome) or infections.

PL802R

Laparoscopic DS clip applier forceps for DS clips SMALL-MEDIUM ∅5.5/310 mm

purple

PL806R

Laparoscopic DS clip applier forceps for DS clips MEDIUM ∅10/310 mm

light blue

PL807R

Laparoscopic DS clip applier forceps for DS clips MEDIUM-LARGE ∅10/310 mm

green

Laparoscopic DS clip applier forceps for DS clips LARGE ∅12/310 mm

orange

PL809R

Laparoscopic DS clip applier forceps for DS clips X-LARGE ∅12/310 mm

light grey

PL822R

Laparoscopic DS clip applier forceps for DS clips SMALL-MEDIUM ∅5.5/420 mm

purple

PL826R

Laparoscopic DS clip applier forceps for DS clips MEDIUM ∅10/420 mm

light blue

PL827R

Laparoscopic DS clip applier forceps for DS clips MEDIUM-LARGE ∅10/420 mm

green

Laparoscopic DS clip applier forceps for DS clips LARGE ∅12/420 mm

orange

PL808R

PL828R

2.4

Relative contraindications

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 procedural, not product-specific and include infection, migration/dislocation of the clip with the possibility of (re)opening of a closed cavity organ/vessel (such as bleeding), necrosis of the clipped structure, injury to the treated or neighboring tissue structures and sensitivity to the metal components of the clip.

2.5

Safety information

The DS titanium ligature clips may only be used with the special Aesculap applier and removal forceps for DS titanium ligature clips. Applier or removal forceps supplied by other manufacturers must not be used.

2.5.1

Laparoscopic DS clip applier forceps

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in applications according to its intended use, see Intended use. ► Clean (manually or mechanically) any new product that is supplied from the factory after it has been removed

from the transport packaging and before first sterilisation, see Validated reprocessing procedure. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► Ensure that the sealing cap is fitted securely on the Luer lock irrigation connector to prevent gas loss during

insufflation.

2.5.2

DS titanium ligature clips

DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

Note The sizes of the DS clip application forceps and clip magazine 8 are recognizable by the color code 7 and by the clip size label 14. ► Fix the clip cassette 8 onto a sterile surface using the adhesive strips 11 in order to guarantee secure positioning. ► Insert jaw parts 1 of the DS clip application forceps with slight pressure vertically up to the stop in the shaft of

the clip magazine 8, see Fig. A. WARNING Breakage of the clip when touching with activated ultrasonic instrument and as a result re-opening of the clipped vessel! ► Do not touch the clip with an activated ultrasonic instrument. The product is gamma-sterilized and supplied in sterile packaging. The product must not be reused. ► Read, follow, and keep the instructions for use. ► Use the product only in applications according to its intended use, see Intended use. ► Store any new or unused products in a dry, clean, and safe place. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience. ► Store implant components in their original packaging. Remove them from their original protective packaging

only just prior to application. ► Prior to use, check the product expiry date and verify the integrity of the sterile packaging. ► Do not use implant components that are past their expiration date or whose packaging is damaged.

2.5.3

Product

Product-specific safety information Interactions between MRI and implant components!

■ MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an additional risk to implant wearers.

■ Implants produce moderate MRI artifacts. Note The applicability of ligating clips (in the respectively available clip size) depends on the size of the structure and is at the discretion of the user. Use is also effected in the context of the vessel condition and/or whether clip application is generally indicated. The position of the clip must be checked by the user after application.

■ 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 implant components used, along with the article number, implant designation, patient label and batch and serial number (if applicable), must be documented in the patient records. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ■ Do not, under any circumstances, use damaged or surgically excised clips. ■ Clips and clip cassettes that have been used before must not be reused.

2.5.4

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Single-use products DS titanium ligature clips The DS titanium ligature clips are implants that are only intended for single use. DANGER Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product! ► Do not reuse the product.

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

2.6

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. WARNING Risk of injury when using the product beyond 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 applier forceps is not insulated. ► Do not apply any current to the DS clip applier forceps. WARNING Risk of dislocation of clips from cutting tissue too close to clip! ► When cutting clipped structures, leave an area of tissue of at least the width of a clip between the clip and cutting site. ► Ensure that the structure is not under tension when cutting. CAUTION Damage/loss of the clip! ► Hold the DS clip application forceps by the shaft for clip removal from the clip magazine. ► Carefully insert the DS clip application forceps straight and central through the trocar. ► Do not close jaw parts when inserting through the trocar. ► Select the clip size according to the case of application.

Note Clip cassettes 8 with a hollow on the upper surface and a raised handle recess contain clips with tooth 13. The labeling of the position of the tooth 9 marks the position of the tooth in the clip cassette 8. ► Always ensure that the tissue to be ligated is fully inside the clip. A deviating procedure is within the discretion

of the user. ► Only use the DS clip applier forceps with the appropriate clip cassette.

► Remove the DS clip applier forceps from the clip cassette 8 using the clip that is positioned in the jaw part 1,

see Fig. B. Simplified identification of the empty clip shafts by protruding wing, see Fig. C. ► Check that the clip is positioned correctly in the DS clip applier forceps: – Guiding ridges 2 of the jaws 1 must be in the slot 12 of the DS clip, see Fig. D/Fig. E. – The clip must be positioned all the way into the DS clip applier forceps, see Fig. E. ► Close the clip: press the DS clip application forceps together to the stop. Make sure the clip is applied under visual control. ► Check the fit and operability of the clip. Note Optionally, incorrectly placed clips can be removed with the Aesculap clip removal forceps, sizes MEDIUM, MEDIUMLARGE and LARGE, see Accessories / spare parts. ► If necessary apply further clips. ► Dispose of the opened clip cassette 8 after the surgical procedure.

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.a-

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

3.3

Single-use products

DS titanium ligature clips The DS titanium ligature clips are implants that are only intended for single use. DANGER Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product! ► Do not reuse the product.

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling 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 opportunity to recognize a product that 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

► Remove the sealing cap from the Luer lock connector. ► Remove the star-type reel stand.

3.7

Cleaning/Disinfection

3.7.1

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 – that are approved for 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.

3.7.2

3.9

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

■ Only DS clip applier forceps

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Place the product on a tray that

■ Only DS clip applier forceps

is suitable for cleaning (avoid rinsing blind spots).

■ Connect components with

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

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

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

■ Chapter Manual pre-cleaning

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

-

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

with a brush

■ Chapter Mechanical alkaline

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

cleaning and thermal disinfecting

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

■ To flush the product: Use a flushing nozzle or flushing sleeve.

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

infection procedure.

■ Keep working ends open for cleaning.

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

3.8

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).

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.

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.

3.8.1

Manual cleaning with ultrasound and immersion disinfection

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.

Phase

Step

3.9.2

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic 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

-

RT (cold)

5

III

Disinfection

2

D–W

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

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

■ working solution 0.5% – pH = 11*

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-

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. 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.

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

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.

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 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 Tech-

nical service.

3.10.2 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). ► 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 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.

3.12 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► 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.

3.13 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: ■ TA013409 – DS clip applier forceps for open surgery and DS titanium ligature clips ■ TA013510 – DS clip removal forceps

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. TA013285

2020-08

Change No. 62178