Pneumatic clip applier (with insertable titanium clip cassette and CO2cartridge)

en ®

Aesculap Pneumatic clip applier (with insertable titanium clip cassette and CO2 cartridge)

2.2

Areas of use and limitations of use

2.2.1

Intended use

The pneumatic clip applier (with insertable titanium clip cassette and CO2 cartridge) is used for the ligation of vessels and hollow organs and for marking anatomical structures. The product is used in combination with Aesculap titanium clip cassettes.

2.2.2

1 Star wheel 2 Screw handle 3 Cartridge adapter 4 Flap (catridge compartment) 5 Application lever (for closing the clip) 6 Retaining ring 7 Pushing rod 8 Inner tube 9 Shaft 10 Lubrication points 11 Space for titanium clip cassette 12 Jaws protector 13 Cartridge 14 Stop (cartridge adapter) 15 Cassette feeder 16 Stop (jaw protection)

Note Ligating clips are intended for use on vessels and tissue structures (e.g. the biliary tract) for which the surgeon believes ligating clips are the best tools. The size, type and material of the clip are selected by the surgeon, based on his experience, estimation and requirement.

2.2.3

2.2.4

Relative contraindications

The following conditions, individual or combined, may result in delayed healing or compromised surgical success: ■ Medical or surgical conditions that could prevent the success of the operation, e.g. connective tissue disorders (e.g. Marfan syndrome) or infections. In the case of relative contraindications, the user decides individually on the use of the product.

About this document

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.

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

1.1

Absolute contraindications

Do not use: ■ on the central nervous system ■ in case of foreign-body sensitivity for titanium ■ in contraceptive procedures such as tubal litigation, vasectomy

2.3

1.

Indications

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

Legend

Scope

These instructions for use apply for the following products:

2.4

Safety information

Art. no.

Designation

2.4.1

Clinical user

PL520R

CHALLENGER TI-P HANDLE

PL522R

SHAFT COMPL.D:5MM L:310MM

PL536R

SHAFT COMPL.D:10MM L:370MM

PL538R

SHAFT COMPL.D:10MM L:260MM

PL603R

MULTIF.CLIP APPL.TI-P 5/205MM F.SM-CLIPS

PL604R

MULTIF.CLIP APPL.TI-P 5/310MM F.SM-CLIPS

PL606R

MULTIF.CLIP APPL.TI-P 10/370MM F.ML-CLIP

PL608R

MULTIF.CLIP APPL.TI-P 10/260MM F.ML-CLIP

PL609R

SHAFT TI-P ALL.5/205MM F.HANDLE PL520R

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.

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

eifu.bbraun.com

1.2

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. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.4.2

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.

Product-specific safety information

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. ► To avoid damage to the jaws and the titanium clip cassette: carefully insert the pneumatic clip applier through

the trocar.

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

► In order to prevent unintentional releasing of the shaft from the handle by retracting the star wheel: push the

2.

Clinical use

► Keep the jaws protector installed when the product is not in use. ► Only use the product with visual control.

2.1

Available sizes

retaining ring 6 onto the handle to the star wheel from above and rotate by 180°.

2.4.3

Designation

Art. no./Dimensions

Pneumatic clip applier (with insertable titanium clip cassette and cartridge), complete

PL606R

PL608R

PL604R

PL603R

Shaft diameter

10 mm

10 mm

5 mm

5 mm

Length

370 mm

260 mm

310 mm

205 mm

2.5

Handle only

PL520R

PL520R

PL520R

PL520R

Shaft only (including interior tube and pushing rod)

PL536R

PL538R

PL522R

PL609R

Pushing rod only

PL536801

PL538801

PL522800

PL601800

Inner tube only

PL536802

PL538802

PL522801

PL601801

Jaws protector

PL536810

PL536810

PL522810

PL522810

Retaining ring

PL520301

PL520301

PL520301

PL520301

Titanium clip cassette, size: small-medium including cartridge (12 cassettes, each with 12 clips and 12 cartridges)

-

-

PL574T

PL574T

Titanium clip cassette, size: medium-large including cartridge (12 cassettes, each with 8 clips and 12 cartridges)

PL579T

PL579T

-

-

Challenger Ti-P CO2-cartridges alone (3 cartridges)

PL575SU

Sterility

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

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 to the patient and/or damage to the instrument if incompatible trocars are used! ► When using the instrument with a trocar: – Check the compatibility of the trocar and instrument (with titanium clip cassette). – Guide instrument into or out of the trocar only with opened jaws. WARNING Risk of dislocation of clips by 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. ► Insert the clip applier carefully, in a straight line and centrally through the trocar.

2.5.1

Setting up the pneumatic clip applier

Demounting the jaws protector ► Compress the jaw part protection 12 and carefully remove it in the direction of the shaft, see Fig. K. PL575SU

PL575SU

PL575SU

Assembling the pneumatic clip applier ► For instruction on how to assemble the pneumatic clip applier, see Chapter 3.12.

Inserting a cartridge Note The flap of the cartridge compartment must be closed in one swift, continuous movement; otherwise, at the moment of broaching, the cartridge pressure will force open the flap of the cartridge compartment and the cartridge will be emptied! ► Open flap of the cartridge compartment 4: pull lateral surfaces of the gray flap of the cartridge compartment 4

backward. ► Insert the cartridge 13 with the round side to the stop 14 into the cartridge adapter 3, see Fig. D.

The flat side of the cartridge 13 is visible. ► Close the flap of the cartridge compartment 4, see Fig. E, making sure that application lever 5 is not caught or

pushed back. The cartridge 13 is broached automatically. Note The pushing rod 7 may move forward and back in the shaft 9 when the cartridge is broached! Function check Note During function checks, pushing rod 7 moves only if the application lever is pressed far enough. ► Push application lever 5 of the pneumatic clip applier through to the limit stop and release it again, see Fig. H.

Application lever 5 moves back to its rest position. Any forward and backward movement of the pushing rod 7 must take place in the shaft 9 and be visible on the space for the titanium clip cassette 11. Inserting the titanium clip cassette ► Insert the titanium clip cassette with cassette feeder 15 in shaft 9, making sure that the feeder is not damaged in the process, see Fig. F. ► Push down the titanium clip cassette until the lugs at its sides engage in the pneumatic clip applier, see Fig. G. The pneumatic clip applier is ready for use now.

2.5.2

Operating the pneumatic clip applier

CAUTION Malfunction of the titanium clip cassette due to use of the same cartridge for more than one cassette! ► Replace the cartridge as well when changing the titanium clip cassette.

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. Evidence of biocompatibility and processibility for the product was produced by the manufacturer after 50 processing cycles. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Chapter 3.11. The recommended annual servicing reduces the risk of failure and extends the service life of the product; see Chapter 4.1.

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

► Make sure the cartridge of the pneumatic clip applier has been removed, see Chapter 3.6.2. ► Fixation screws which permanently connect the various components must not be disassembled. ► Disassemble the product prior to cleaning, see Chapter 3.6. ► Open up instruments with hinges.

3.6

Disassembly

3.6.1

Removing the titanium clip cassette

► Close the jaws with the application lever 5 and withdraw the titanium clip cassette, see Fig. I.

3.6.2

Removing the cartridge

WARNING Alarm caused by residual gas hissing out when opening the flap of the cartridge compartment! ► Inform O.R. personnel of impending cartridge change. ► Open flap of the cartridge compartment 4: pull lateral surfaces of the gray flap of the cartridge compartment 4

backward. ► Remove cartridge 13 from cartridge adapter 3 against the direction of the arrow, see Fig. D.

3.6.3

Disassembling the pneumatic clip applier

Note The last clip in each titanium clip cassette is color-marked in order to indicate that the titanium clip cassette will be empty after the present application!

► With retaining ring 6 mounted: rotate the retaining ring 6 until the opening of the ring points downward in the

Note Do not close the jaws of the instrument when inserting/approaching the structure to be clipped.

► Pull off retaining ring 6 towards rear of handle, see Fig. A.

► Load clip: Push application lever 5 to the stop and release it again.

Application lever 5 moves back to its rest position. The next clip is automatically fed into the jaws after each complete push and release movement of application lever 5. Note In case of any malfunction at this stage, clip loading must be inspected and repeated extracorporeally. ► Close clip: Push application lever 5 of the pneumatic clip applier through to the limit stop, see Fig. H. ► Close the clip only in the clip guide in the jaws of the pneumatic clip applier. Make sure the clip is applied under

visual control. ► Check the fit and operability of the clip. ► If necessary apply another clip. ► Dispose of titanium clip magazine and cartridges after the operation.

2.5.3

Changing the titanium clip cassette and the cartridge

► Remove the empty titanium clip cassette, see Chapter 3.6.1. ► Remove empty cartridge 13, see Chapter 3.6.2. ► Insert new cartridge 13, see Chapter 2.5.1. ► Carry out function check, see Chapter 2.5.1. ► Insert new titanium clip cassette, see Chapter 2.5.1.

3. 3.1

Validated reprocessing procedure 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.

direction of the application lever 5. ► Hold the shaft 9, pull the rotary ring 1 to the stop in the direction of the handle 2 and remove the shaft 9,

see Fig. J.

3.6.4

Disassembling the shaft

► Withdraw inner tube 8 from shaft 9. ► Pull the pushing rod 7 from the inner tube 8.

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 peek plastics and stainless 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. Contamination or obstruction of the valve mechanism due to impact of cleaning agents! ► Do not apply ultrasonic immersion for cleaning the handle. ► Compress jaws protector 12 and carefully guide it over the jaws to the stop 16 of the outer tube, see Fig. L. ► If the product can be fixated on storage devices safely and appropriately for cleaning: carry out mechanical

cleaning and disinfecting. ► Only dispose of the product dry, as otherwise contamination may penetrate into the shafts.

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush: e.g. PM995R or

Chapter Manual cleaning/disinfection and subsection:

■ Shaft

■ Drying phase: Use a lint-free cloth or medical

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".

■ Chapter Manual cleaning with ultrasound and immersion disinfection

compressed air Mechanical alkaline cleaning and thermal disinfection

■ Screw handle

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.

■ Single use syringe 20 ml ■ Place the jaw part protection 12 onto the product.

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.

GK469R

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Shaft

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

■ Place the product on the tray with flap of cartridge compartment 4 open, see Fig. A.

■ Suitable cleaning brush: e.g. PM995R or GK469R

■ Single use syringe 20 ml ■ Place the jaw part protection 12 onto the product.

■ 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.

Chapter Mechanical cleaning/disinfection and subsection:

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

■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.8

Manual cleaning/disinfection

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

► 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.

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).

3.8.1

Manual cleaning with ultrasound and immersion disinfection

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

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

3.10.1 Manual pre-cleaning with ultrasound and brush

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

Phase

Step

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

Rinsing

RT (cold)

1

-

D–W

-

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

-

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

V

Drying

RT

-

-

-

-

► Note the information on appropriate cleaning brushes and disposable syringes, see Chapter 3.7.2.

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 Chapter 3.7.2.

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 Chapter 3.7.2.

3.9

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.

3.9.1

Mechanical alkaline cleaning and thermal disinfection

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

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

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.

3.10.2 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: – pH ~ 13 – <5 % anionic surfactant

■ 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:

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.

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

3.11.1 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

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

scratched and fractured components.

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* 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

► 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

Chapter 4.2.

3.11.2 Functional test CAUTION Damage to sealing components caused by maintenance spray-lubrication of the handle! ► Do not spray-lubricate the handle. ► Only spray marked areas in the shaft, see lubrication locations 10 in Fig. B.

D–W: FD–W:

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

CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Lubricate the labeled lubricating points 10 before the functional test using the maintaining oil suitable for the sterilization procedure used (e.g. for steam sterilization STERILIT® I oil spray JG600 or STERILIT® I drop-feed lubricator JG598).

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

► Assemble disassembled products, see Chapter 3.12. ► Check that the product functions correctly.

– Close jaws from the tip to the rear. – The tips must contact when the jaws are closed. – the closed jaws may not intersect. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Make sure the cartridge of the pneumatic clip applier has been removed, see Chapter 3.6.2. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Chapter 4.2.

3.12 Assembly CAUTION Malfunctions caused by incorrect assembly sequence! ► Keep to the correct order of assembly.

3.12.1 Assembling the shaft ► Push the pushing rod 7 into the inner tube 8. ► Push the inner tube 8 into the shaft 9 using the pushing rod 7.

3.12.2 Assembling the pneumatic clip applier ► Pull the rotary ring 1 to the stop in the direction of the handle 2. ► Hold the rotary ring 1 on the stop and push in the assembled shaft 9. Press the shaft 9 against the handle 2 and

turn it until the marking lines are in line with the shaft 9 and star wheel 1 and the star wheel 1 snaps forward, see Fig. C. ► Install retaining ring 6 on handle 2 between star wheel 1 and application lever 5 and twist the ring by 180°.

3.13 Packaging ► Place the product in its holder or on a suitable tray. Make certain the jaws are protected. ► 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.

3.14 Steam sterilization CAUTION Loss of sterility of/damage to the handle caused by cartridge left in the pneumatic clip applier! ► Make sure that no cartridge is left in the pneumatic clip applier under any circumstances. ► If a cartridge remains after sterilization: check handle for functionality and sterilize again. 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.

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

4.

Maintenance and Service

4.1

Maintenance

To ensure reliable operation, Aesculap recommends maintaining the product as indicated on the maintenance label, see Fig. M. ► For corresponding services, contact your national B. Braun/Aesculap agency. see Chapter 4.2

4.2

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.

4.3

Accessories/Replacement Parts

Accessories and spare parts are listed in the Endoscopy online catalog at www.endoscopy-catalog.com or in the Aesculap brochure C62311.

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.

6.

Symbols on product and packaging Maintenance labeling on the handle and shaft with a note regarding the next maintenance deadline, see Chapter 4.1

YYYY-MM TA012509

2020-09

V6

Change No. 63464