Targon – Explantation instruments

KH294R

KH299R

9

KH298R

10

KH297R

11

KH296R

12

KH279R

13

KH278R

14

KH215R

15

KH216R

16

KH289R

17

1

KH276R

2

KH275R

3

A KH291R

4

KH292R

5

KH293R

6

KT233R

7

E

B

F KH286R

8

C a KH290R

D G

18

3 6 4 b D c d e

H

1

f 2 5

Socket extractors (Fig. E)

en ®

®

Aesculap Targon Explantation instruments Legend A B C D E F G

Trephine cutters Extractor Cover sleeve Extractor in use Socket extractor Socket extractor in use Hexagon wrench/T-handle a Set screw H Extraction instruments for broken-off intramedullary locking nails b Extraction instrument c Sleeve d Conical internal thread e Distal nail fragment f Lever instrument

1.

About this document

No.

Designation

Inner ∅, at the front (mm)

9

Socket extractor KH299R for screw shaft ∅ 6 mm

6

10

Socket extractor KH298R for screw shaft ∅ 5 mm

5

11

Socket extractor KH297R for screw shaft ∅ 4.5 mm

4.5

12

Socket extractor KH296R for screw shaft ∅ 3.5 mm

3.4

13

Socket extractor KH279R for screw head (D8mm) of screws of ∅ 6 mm, 5 mm and 4.5 mm and for the Targon PFT anti-rotation pin

8

14

Socket extractor KH278R for screw head (D7mm) of screws of ∅ 3.5 mm and for the Targon PF antirotation pin

7

15

Socket extractor KH215R for Targon support socket with thin connection area ∅ 10.5 mm

10.5

16

Socket extractor KH216R for Targon support socket with thicker connection area ∅ 12 mm

12

Further range (Fig. G)

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

No.

Designation

1.1

20

Hexagon wrench KH289R, 6 mm and 4,5 mm

21

T-handle KH290R, 6 mm (reinforced)

Scope

These instructions for use apply for Targon explantation instruments. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► 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 messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Product description

2.1.1

Available sizes

Trephine cutters (Fig. A) No.

Designation

Inner ∅ (mm)

Outer ∅ (mm)

1

Trephine cutter KH294R for reaming over the screw head of Targon screws with ∅ 6 mm, 5 mm, 4.5 mm and 3.5 mm and the anti-rotation pin

8.2

10.7

2

Trephine cutter KH276R for reaming over the screw shaft of Targon screws with ∅ 6 mm, 5 mm and 4.5 mm

6.2

8.5

3

Trephine cutter KH275R for reaming over the screw shaft of Targon screws with ∅ 3.5 mm

3.7

5.5

Extractors (Fig. B) No.

Designation

Outer ∅, at the front (mm)

4

Extractor KH291R for defective hexagonal sockets SW 4.5 mm of locking screws, support screws, antirotation pins and PFT Telescrews

4.8

5

Extractor KH292R for defective hexagonal sockets SW 3.5 mm of locking screws, and for threaded sleeves

3.8

6

Extractor KH293R for Targon support sleeve with defective connector

6.5

Extractor KT233R (slim shaft) for defective hexagonal socket SW 3.5 mm of FN Telescrews

3.8

7

Compression sleeve (Fig. C) No.

Designation

Inner ∅, at the front (mm)

8

Cover sleeve KH286R

11.2 12.5

Extraction instruments The extraction instruments are available in several diameters. There also is a lever instrument KH327R for levering out the nail fragment to be extracted. Art. no.

Nominal inner ∅ (mm)

Outer ∅ (mm) D

KH326R

7

9

KH328R

8

10.5

KH329R

9

11.5

KH330R

10

12.5

KH331R

11

13.5

KH332R

12

14.5

KH217R

13

15.5

KH218R

14–15

17

KH219R

17

19

2.2

Areas of use and limitations of use

2.2.1

Intended use

Explantation of Targon implants (Targon F, Targon T, TX, Targon PF, PFT, FN, Targon RF, Targon PH/PH+,Targon H/H+) or in case of complicated conditions, e.g. damaged, jammed or sessile implants or in case of damaged instruments. Intended use of trephine cutters The trephine cutters are used for reaming over implants, loosening screws in the bone and for applying the socket extractor (Fig. D) to the implant. To be used for: ■ locking screws, to ream over the screw head and the insertion cortex, to slightly loosen the screws. After that the extractor can be applied to the hexagonal socket of the screw, or the socket extractor to the screw head. ■ locking screws, for reaming over the screw shaft or the insertion cortex, if the screw head has broken off. After this preparation, the socket extractor can be applied. ■ the anti-rotation pin and the support socket, for reaming over the end and subsequent use of the socket extractor. Intended use of the extractors The extractors are used for undoing the locking screws, the anti-rotation pin, the support sockets, the support screws and the threaded sleeves. The extractor is inserted in the hexagonal socket or in a hole drilled into the implant component (Fig. E and F). Use it if the hexagonal socket or the connecting piece of the implant component has been turned smooth or damaged. Intended use of the cover sleeve The cover sleeve KH286R serves as auxiliary instrument for explanting a damaged or cracked Targon PF support socket by means of the conical extractor KH293R. The cover sleeve prevents the support socket from expanding and thus helps preventing the extractor from disengaging (slippage). Intended use of socket extractors The socket extractors are used for extracting the locking screws, the anti-rotation pin, the support sockets and the support screws. The socket extractor is applied around the outer circumference of the implant (Fig. F). Use it if the screw head has broken off or the extraction efforts with the extractor were unsuccessful. Intended use of extraction instruments for broken-off intramedullary locking nails These extraction instruments serve for removing broken-off locking nails from the medullary cavity. The extraction instruments can be used for titanium nails as well as for steel alloy nails.

2.2.2

Indications

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

2.2.3

Absolute contraindications

No known absolute contraindications.

2.2.4

Relative contraindications

The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the operation. In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.3

Safety information

2.3.1

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. ► 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.

Removing the nail fragment ► Ensure, that the diameter of the medullary cavity is larger than the outer diameter D of the instruments (Step 1). ► If necessary, bore up the medullary cavity. ► After removing the last locking screw on the nail fragment, insert the lever instrument through the locking drill hole (Step 2). ► Lever free the nail fragment and lock the instrument. ► Adapt the T handle and insert the extraction instrument into the medullary cavity (Step 3). ► If the instrument does not move smoothly, bore up the cavity in steps of 0.5 mm. Important: The inside of the sleeve must be clean. ► Pull the sleeve over the nail fragment and tighten by turning clockwise (Step 4). ► Remove the lever instrument (Step 5). ► Extract the nail fragment (Step 6). If necessary, hammer it out with quick, soft knocks with a slotted mallet. Note For sessile intramedullary nails and/or if the nail fragment is relatively long, additional surgical measures may be required to loosen the nail fragment.

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

2.3.2

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

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.

2.4

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

Sterility

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 and visual inspection prior to each use of the product. WARNING Risk of failure of the extraction instruments when implant components are stuck or jammed too solidly! ► Always try slightly loosening the implant component before applying the extraction instruments, in order to remove the bone substance grown around the implant. ► Ream over screws with the trephine cutters; ream over the support socket with trephine cutter KH422R ∅ 13,6 mm / 16 mm and slightly lever it out with the hexagon wrench. We recommend the following sequence of application of the trephine cutters, the extractors and the socket extractor:

2.4.1

Trephine cutters (Fig. A)

► Adapt the trephine cutters to a T handle. ► Ream over the implant component by hand, in the direction of the alignment.

Note If necessitated by hard cortical bone, the implant can also be reamed over carefully with a motor-powered trephine cutter.

2.4.2

Extractors (Fig. B)

► Clean the area of the hexagonal socket or the drill hole. ► Adapt the appropriate extractor to a T handle. ► Apply the extractor along the implant axis and turn it counterclockwise, applying mild pressure.

The conical left-hand thread jams in the drill hole and tightens itself. ► Continue extracting the implant by turning the socket extractor counterclockwise (Fig. D).

If the extractor fails to engage deeply enough in the hexagonal socket head of the screw and therefore cannot perform its function: ► Ream off the bone material around the screw with the trephine cutter and apply the socket extractor.

2.4.3

Cover sleeve (Fig. C)

► Remove residues of sessile bone from in front of the Targon PF support socket. ► Push the cover sleeve over the connection-side end of the support socket (applying slight taps with a hammer,

if necessary). ► Insert the conical extractor through the cover sleeve. ► Extract the support socket.

2.4.4

Socket extractors (Fig. E)

► Adapt the socket extractor to a T handle. ► Place the socket over the implant and turn the socket extractor counterclockwise, applying mild axial pressure.

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

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.

The conical left-hand thread jams on the implant surface and tightens itself. ► Continue extracting the implant by turning the socket extractor counterclockwise (Fig. F).

Note For expanded or worn implant components, carry out the extraction procedure with next larger socket extractor.

2.4.5

Extraction instruments for broken-off intramedullary locking nails (Fig H)

Function The extraction instrument has a sleeve with a conical internal thread attached to it. This threaded sleeve is screwed onto the nail fragment, where it locks itself and can be pulled out with the extraction instrument. Preparing the application ► Prior to the operation, it must be ensured that the correct instrument for the diameter of the nail at the breaking line is available (especially in cases of connector-side nail fractures). The diameter of solid locking nails usually increases towards the nail connection. ► Remove any connection-side locking screws and the connection-side nail fragment. ► Determine which extraction instrument has to be used at the fracture line of the connection-side nail fragment by sliding the sleeve over the nail fragment. At least 1 mm length of the nail fragment must fit into the sleeve. Note In cases of connection-side fractures of nails supplied by other manufacturers, the diameter even of the largest extraction instrument might be too narrow. To be certain that you have the appropriate tool available, please contact the implant manufacturers.

3.5

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly.

3.6

Disassembly

KH290R ► Remove set screw a from T-handle.

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 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. ► In case of bone or tissue residues on the product: Pre-clean the product manually with a suitable cleaning brush.

3.7.2

3.9

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

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

■ All articles

■ Chapter Manual cleaning with immersion disinfection

■ Do not use metal cleaning

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

■ KH286R ■ KH289R ■ KH291R ...KH293R ■ KH327R ■ KT233R

■ KH286R: rinsing the products under flowing water required, move movable parts.

Chapter Mechanical cleaning/disinfection and subsection:

■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ KH215R ... KH219R ■ KH275R... KH279R ■ KH290R ■ KH294R ■ KH296R ... KH299R ■ KH326R ■ KH328R ... KH332R 3.8

brushes or other abrasives that would damage the product surface and could cause corrosion.

Mechanical alkaline cleaning and thermal disinfecting

Phase

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

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%

cleaning and thermal disinfecting

nels, use flushing lances or flushing sleeves in the injector carriage.

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Do not use metal cleaning

3.9.1

■ Chapter Mechanical alkaline

■ For flushing the lumens/chan-

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

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Machine type: single-chamber cleaning/disinfecting machine without ultrasound

brushes or other abrasives that would damage the product surface and could cause corrosion.

Mechanical alkaline cleaning and thermal disinfection

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).

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ KH290R: for flushing the lumens/channels, use flushing lances or flushing sleeves in the injector carriage.

– 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

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.

3.10 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).

■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

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

Manual cleaning/disinfection

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

3.10.1 Manual pre-cleaning with a brush

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

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

3.8.1

Manual cleaning with immersion disinfection

I

Disinfecting 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

II

Rinsing

RT (cold)

1

-

D–W

-

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

-

-

-

-

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-

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-

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.

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.

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

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.

■ working solution 0.5% – 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

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.

3.11 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

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.11.2 Functional test ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check rotating products (e.g. reusable drills and cutters) for bends and deformities. To do this, roll the product

on an even surface. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.12 Assembly KH290R ► Screw set screw a into T-handle.

3.13 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.

3.14 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.

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

4.

Technical service

CAUTION Modifications to medical technology equipment result in loss of approval and can result in forfeiture of guarantee/warranty claims. ► 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.

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. TA010483

2020-11

V6

Change No. 63662