Clip applier forceps for open surgery and titanium ligating andmarking clips

en ®

Aesculap Clip applier forceps for open surgery and titanium ligating and marking clips Legend 1 2 3 4 5 6 7 8

Handle with color coding, clip applier forceps Jaws Guideway Lubrication points Clip cassette Clip Adhesive strips Clip size labeling

1.

About this document

Scope

These instructions for use apply for clip applier forceps and titanium ligating and marking clips. ► 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

Safety information

2.4.1

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. ► Always follow the safety advice and information given in the instructions for use. ► 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. ► 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.

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

1.1

2.4

Safety messages

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. Aesculap is not responsible for complications caused by: ■ incorrect indication or implant selection ■ incorrect surgical technique ■ incorrect combination of implant components ■ combination not approved by Aesculap with components from other manufacturers ■ exceeding the limitations of the treatment method or non-observance of essential medical precautions The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

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:

2.4.2

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

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.

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

2.

Clinical use

2.1

Product description

2.1.1

Titanium ligating and marking clips material

2.1.2

Available sizes

■ Pure titanium acc. to ISO 5832-2 ■ Not transparent to X-rays

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. The titanium ligating and marking clips must only be used with the special Aesculap applier and removal forceps for titanium ligating and marking clips. ► Do not use applier or removal forceps supplied by other manufacturers.

2.4.3

Titanium ligating and marking clips Single-clip applier forceps for

Color code

Micro clips

white

Small clips

yellow

Medium clips

blue

Medium-large clips

green

Large clips

orange

Product-specific safety information

Sterility

Clip applier forceps The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Titanium ligating and marking clips The product has been EO-sterilized and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Store implant components in their original packaging. Remove them from their original protective packaging only just prior to application. ► Do not use the product after its use-by date. ► Do not, under any circumstances, use damaged or surgically removed clips. ► Do not reuse the clip cassettes and clips.

Clip applier forceps Complete overview of the clip applier forceps, see online catalog www.chirurgische-instrumente.info

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.

2.2

Areas of use and limitations of use

2.5

Application

2.2.1

Intended use

2.5.1

Documentation

The clip applier forceps for open surgery and the titanium ligating and marking clips are used for the ligation of vessels and hollow organs and for marking anatomical structures for radiological detection. Note Ligature clips are intended for use on vessels or tissue structures (such as bile ducts), 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.

2.2.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

■ Ligature of vessels and hollow organs ■ Marking of anatomic structures for radiological detection 2.2.3

Absolute contraindications

Do not use: ■ in case of foreign-body sensitivity for titanium ■ in contraceptive procedures (such as tubal litigation, vasectomy.

2.2.4

Relative contraindications

Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the operation, e.g. disorders of the connective tissue (Marfan syndrome) or infections.

2.3

Risks, adverse effects and interactions

As part of the legal duty to inform, the following typical risks, interactions and side effects associated with the use of surgical instruments are pointed out. Possible risks, side effects and interactions of the application currently known to the manufacturer are: ■ 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

Each package contains additional labels showing the designation, article and lot number and – if applicable – the individual serial number of the product. ► Use these labels for documentation in the patient’s file.

2.5.2

Implantation

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 clip applier forceps is not insulated. ► Do not apply any current to the 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 double the clip between the clip and cutting site. ► Ensure that the structure is not under tension when cutting. CAUTION Risk of damaging/losing the clip when removing it from the clip cassette! ► Do not close the clip applier forceps when removing the clip. ► Select the clip size according to the case of application. ► Ensure that the tissue to be ligated is fully inside the clip. ► Only use the clip applier forceps with the appropriate clip cassette.

Note The sizes of the clip applier forceps and the clip cassettes 5 can be seen in the color code 1 and on the clip size labeling 8.

► Fix the clip cassette 5 onto a sterile surface using the adhesive strips 7 in order to guarantee secure positioning,

see Fig. A. ► Insert the jaw parts 2 of the clip applier forceps vertically all the way into the shaft of the clip cassette 5 with gentle pressure, see Fig. A. ► Remove the clip applier forceps from the clip cassette 5 using the clip 6 that is positioned in the jaw part. ► Check that the clip is positioned correctly in the clip applier forceps, see Fig. B. – flush in the jaw part of the clip applier forceps – not twisted, tilted or imprecisely positioned ► To close the clip: Press the clip applier forceps together with appropriate force. Make sure the clip is applied under visual control. ► Check the fit and operability of the clip.

3.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Keep working ends open for

Chapter Manual cleaning/disinfection and subsection:

■ Clip applier forceps

cleaning.

3.

Validated reprocessing procedure

3.1

General safety instructions

immersion disinfection

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

Note Optionally, incorrectly placed clips can be removed with the Aesculap clip removal forceps, see Accessories / spare parts. ► If necessary apply further clips. ► Dispose of the opened clip cassette 5 after the surgical procedure.

■ Chapter Manual cleaning with

■ When cleaning instruments

■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Clip applier forceps

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline

■ Keep working ends open for

cleaning and thermal disinfecting

cleaning.

■ Place the product on the tray

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

with all product links and joints open.

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.

3.7

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

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

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.

3.7.1

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

-

-

-

-

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

Single-use products

Titanium ligating and marking clips ► 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

Clip applier forceps 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

Cleaning/Disinfection

3.6.1

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 plastics 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 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

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.

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) 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.

3.8

Mechanical cleaning/disinfection

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.

3.8.1

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

10

FD-W

■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5%

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 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.

– pH = 11* TA009546 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

DW: 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.

3.9

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 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.

3.9.2

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.

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 / spare parts

Information about accessories/spare parts can be found in the following instructions for use: ■ TA008750 – Endoscopic clip appliers ■ TA008986 – Titanium ligating and marking clips ■ TA013903 – Clip removal forceps

2020-07

V6

Change No. 62162