CranioPlate System 1.5 mm - Micro screws and micro plates Instructions for Use

en ®

AESCULAP CranioPlate System 1.5 mm - Micro screws and micro plates Legend A Locked position of the screw magazine (closed) B Operation of screw magazine C Unlocked position of the screw magazine (open) D Couple/decouple the screwdriver blade 1 Handle 2 Sliding ring 3 Blade

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 the CranioPlate System 1.5 mm - Micro screws and micro plates. 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: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

2.4

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. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.4.2

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 bearers. ■ Implants produce moderate MRI artifacts. Depending on the MR pulse frequency, the size of the artifacts may vary.

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The implant components implanted must be documented in all patient records, including the article numbers of components, implant designation, batch number and serial number (if available).

■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques.

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

■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-

2.

Clinical use

2.1

Product description

incorrectly combined implant components and/or operating techniques, the limitations of treatment methods, or lack of asepsis. ■ Do not, under any circumstances, use damaged or surgically removed components. ■ Implants already used must not be reused. ■ The forces to be transferred by the implant must be kept to the achievable minimum. ■ Delayed healing can cause implant breakage due to metal fatigue. ■ Micro screws once removed from the screw magazine must not be put back into the screw magazine. ■ Mesh and micro plates must not be bent multiple times. ■ Replace the screwdriver blade as soon as it is worn (loss of friction). Note The screw heads are not equalized in meshes of 0.3 mm thickness. Note Inappropriate fixation or any combination with other fixation methods (sutures, clamp systems) can result in the formation of steps, shifts of the calvarium and loosening and breakage of implant components. Note Combine implant components of Aesculap CranioPlate System 1.5 mm with each other only.

Additional information on Aesculap implant systems is available from B. Braun/Aesculap or from your local B. Braun/Aesculap agency.

2.1.1

Materials

The materials used in the implant are listed on the packaging: ■ Titanium alloy Ti6Al4V according to ISO 5832-3 ■ Pure titanium according to ISO 5832-2 The titanium implants are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not affect the implant quality.

2.2

Areas of use and limitations of use

2.2.1

Intended use

The CranioPlate system 1.5 mm is used for the osteosynthesis of bone fractures, craniotomized bone flaps and bridging cranial bone defects. It consists of: ■ Micro screws ■ Micro plates ■ Micro meshes There is a special instrument set for implanting these elements. Trays are used for holding or storing medical devices, such as instruments, implants or motor components during cleaning and sterilization, as well as during transport.

2.2.2

Indications

■ Craniofacial surgery ■ Cranial bone flaps ■ Cranial fractures ■ Certain fractures of the midface and craniofacial skull ■ Certain orthognathic fractures of the jaws and chin ■ Other reconstructive indications at the skull 2.2.3

Contraindications

■ Severe osteoporosis or osteomalacia ■ Severely damaged bone structures that could prevent stable implantation of implant components ■ Bone tumors in the region of the implant anchoring ■ Lack of cooperation on the part of the patient ■ Foreign-body sensitivity and oversensitivity against the implant materials ■ Fever ■ Acute or chronic infections in the region of the implant anchoring ■ Degenerative bone diseases ■ Anticipated overload on the implant 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: ■ Changes in position, loosening, wear and tear on, or fracture of implant components ■ Primary and secondary infections ■ Tissue reaction to implant materials ■ Injury to blood vessels and nerves ■ Haematosis and wound healing disorders ■ Implant failure resulting from excessive load: – Warping or bending – Loosening – Breakage – Inadequate fixation – Failed or delayed fusion

sels, muscles, and tendons.

■ Aesculap is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant,

2.4.3

Sterility

The product is delivered in an unsterile condition. For implant components in original packaging: ► Store implant components in their original packaging. Remove them from their original protective packaging only just prior to implantation. ► Use the storage tray for sterilization and sterile prep. ► Ensure that the implant components do not come into contact with instruments in the implant system storage devices. ► Ensure that the implant components are not damaged in any way.

2.5

Application

DANGER Damage to the CNS and poor cosmetic results due to insufficient fixation of fragments and inadequate bridging of bone defects achieved with the meshes! ► Carry out a stability check of the surgical provision. ► Use a more substantial mesh. ► Cover the cranial bone defect with mesh so that it is overlapping to enable sufficient circumferential fixation with screws. ► Insert additional screws. WARNING Tissue irritation caused by sharp cut edges after cutting the mesh! ► Use different cutting forceps. WARNING Risk of implant malfunction due to incorrect application! ► Take care that any excentric motion due to the screwdriver movement is kept to a minimum when inserting the micro screws. ► Insert the screw at right angles to the bone surface plane and the implant. ► Drive in the screw on the screwdriver axis. Do not tilt the screw. ► For hard bone: Predrill the screw holes. The following conditions must be fulfilled prior to application: ■ All the requisite special implantation instruments must be present and in good working order. ■ The operating surgeon and operating room team are thoroughly conversant with the operating technique and with the available range of implants and instruments; information materials on these subjects must be complete and ready to hand. The intervention has been explained to the patient, whose consent concerning the following information has been documented: ■ The implants must not be subjected to overload through extreme strains, hard physical work or exercise. The implant may loosen or suffer material fracture if subjected to excessive load. ■ The patient must be informed about the limits of allowable strain on the implant, and be given appropriate behavior guidelines. The risks of transgressing these rules must be explained to the patient. ■ The patient must undergo regular medical follow-up examinations. Further information on B. Braun/Aesculap implant systems is available at any time from B. Braun/Aesculap or from the responsible B. Braun/Aesculap branch.

3.

Validated reprocessing procedure

3.6.2

3.1

General safety instructions

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml

Chapter Manual cleaning/disinfection and subsection:

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Disassembling the screwdriver

► Retract sliding ring 2 on the handle 1. ► Pull blade 3 out of the handle 1.

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, surgical steel varieties, titanium alloy and pure titanium, – 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. The storage tray is provided only for sterilization. ► Do not process the products in the storage tray (FM910P). Note The micro screws are processed in their screw magazines. The micro plates and micro mesh can be processed in the modules (FM913P and FM915P). ► Process the instruments separately from the implant system storage modules. ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

Validated cleaning and disinfection procedure

■ CranioPlate Instruments

■ Chapter Manual cleaning with

FM903R to FM905R

immersion disinfection

■ CranioPlate Instruments FM916R to FM917R

■ CranioPlate storage units FM910P to FM915P Manual cleaning with ultrasound and immersion disinfection

■ CranioPlate Screwdriver

■ Suitable cleaning brush ■ Disposable syringe 20 ml

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with

FM902R

ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

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

■ CranioPlate Instruments

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline

■ Place the product on the tray

FM903R to FM905R

■ CranioPlate Instruments

cleaning and thermal disinfecting

with all product links and joints open.

FM916R to FM917R

■ CranioPlate storage units FM910P to FM915P

■ CranioPlate screw magazine FM920T to FM929T

■ CranioPlate plates and mesh FM960T to FM983T Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

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

■ CranioPlate Screwdriver

is suitable for cleaning (avoid rinsing blind spots).

FM902R

■ Place the product on the tray

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

with all product links and joints open.

3.7

Manual cleaning/disinfection

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

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

3.7.1

Manual cleaning with 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

-

-

-

-

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.

3.7.2

Manual cleaning with ultrasound and immersion disinfection

3.9

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*

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.

Mechanical cleaning/disinfection with manual pre-cleaning

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

3.9.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

Rinsing

RT (cold)

1

-

D–W

-

IV

Final rinse

RT (cold)

1

-

FD-W

-

II

V

Drying

RT

-

-

-

-

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

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.

3.8

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.

3.9.2

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

-

-

-

According to the program for cleaning and disinfection device

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

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

Mechanical alkaline cleaning and thermal disinfecting

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

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. – 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

-

-

-

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.

► 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) 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). ► Assemble disassembled products, see Assembling the screwdriver. ► 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 Assembling the screwdriver ► Retract sliding ring 2 on the handle 1. ► Push the blade 3 up to the stop in the handle 1.

3.12 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.

3.13 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.

3.14 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.

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. TA011828

2021-09

Change No. AE0061095