activ C-insertion instrument

en

2.3.2 ®

Aesculap activ C-insertion instrument Legend A Insertion instrument and accessories 1 Key (for insertion instrument) 2 Insertion instrument 3 Repositioning instrument 4 Irrigation connector 5 Button 6 Adjusting wheel 7 Clamping sleeve 8 Connector piece 9 Spacer B Revision instrument

1.

About this document

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

1.1

2.4

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. ► Follow OP-Manual no. O31302 and instructions for use “activ C disk prosthesis”, see TA011995. ► Mounting the insertion instrument, see Assembly.

2.4.1

Coupling the implant

WARNING Damage to the implant due to improper handling! ► Follow the instructions for use of activ C disk prosthesis TA011995. ► Mount the implant on the insertion instrument immediately after removing it from the implant packaging. ► Handle the friction surfaces of the prosthesis plates and of the polyethylene inlay with care. ► Open the implant packaging.

Note Do not remove the implant from the packaging! ► Mount insertion instrument 2 on the disc prosthesis with the latter still in its packaging, observing the

Scope

These instructions for use apply for activ C-insertion 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

Sterility

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

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:

"CRANIAL" and "CAUDAL" markings. The superior prosthesis plate (the one with the spikes) must abut the part of insertion instrument 2 marked "CRANIAL", while the inferior prosthesis plate (with the fin) has to abut the part of insertion instrument 2 marked "CAUDAL". ► Turn clamping sleeve 7 clockwise to fixate the intervertebral disc prosthesis on insertion instrument 2. ► Remove the disc prosthesis from its packaging, holding it with the insertion instrument 2.

2.4.2

Inserting the implant

WARNING Damage to vertebral body end plates when the intervertebral disk prosthesis is tapped in! ► Apply proper care when tapping in the intervertebral disk prosthesis.

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

► Carefully, under X-ray control, insert the disk prosthesis into the intervertebral disk space. The superior prosthesis

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

► If necessary impel the implant with light hammer taps on the proximal end of insertion instrument 2.

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

2.

Clinical use

2.1

Available sizes

plate (plate with the spikes) must be oriented cranially, the inferior prosthesis plate (the plate with the fin) caudally.

WARNING Compression of the spinal canal and of other posterior elements caused by the intervertebral disk prosthesis inserted too deeply! ► Prior to inserting the intervertebral disk prosthesis, adjust the depth stop to minimum insertion depth. ► Introduce the disk prosthesis into the intervertebral space under X-ray control. ► If necessary, correct the depth stop position using the adjusting wheel 6 until the intended position is reached. ► Should repositioning become necessary, screw repositioning instrument 3 onto the proximal end of insertion

instrument 2 and carefully, with a slotted hammer, move the implant to its intended position. Art. no.

Designation

2.4.3 FW857R

Insertion instrument with irrigation connector H6

FW863R

Spacer for implant height 5 mm

FW864R

Spacer for implant height 6 mm

Decoupling the implant

Note To avoid damage to the implant, do not couple an insertion instrument that already has been decoupled once. ► Loosen clamping sleeve 7 on insertion instrument 2 by turning it counterclockwise, and remove insertion

instrument 2. ► If clamping sleeve 7 is difficult to loosen, insert key 1 in one of the lateral drill holes of clamping sleeve 7 and

FW866R

loosen clamping sleeve 7 in this way.

Insertion instrument with irrigation connector H5

► On the intraoperative X-ray image, in AP and lateral view, check the size, height and position of the intervertebral

FW867R

Repositioning instrument

FW868R

Revision instrument

3.

Validated reprocessing procedure

FW945R

Key for insertion instrument

3.1

General safety instructions

2.2

Areas of use and limitations of use

2.2.1

Intended use

The insertion instrument is used for picking up the activ C intervertebral disc prosthesis from its sterile packaging, inserting it in the prepared intervertebral space, and carrying out position corrections of the prosthesis.

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

disk implant.

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.

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.

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.

2.3

Safety information

2.3.1

Clinical user

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".

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.

3.2

General information

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.

3.8.1

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

► 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.

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

3.5

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

-

-

-

-

3.4

Preparations at the place of use

Preparing for cleaning

► Disassemble the product immediately after use, as described in the respective instructions for use. ► Disassemble the product prior to cleaning, see Disassembly.

Note During cleaning the clamping sleeve 7 must sit loosely on the instrument shaft. Note To ensure proper cleaning of spacers 9, the PEEK forks must sit loosely (so that they can be turned in both directions) on the thread.

3.6

Disassembly

► Uncouple spacer 9 from insertion instrument 2 by pressing "push to clean" button 5 at the handle of insertion

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh

instrument 2 and simultaneously pulling it out, axially, towards the working end. ► If applicable, unscrew repositioning instrument 3 from insertion instrument 2 by turning it counterclockwise. ► Before reprocessing, ensure that the clamping sleeve 7 is sitting loosely on the instrument shaft.

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

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

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.

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 e.g., aluminum, plastics, high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: 250 mm/∅ 3.7 mm,

Chapter Manual cleaning/disinfection and subsection:

■ FW867R ■ FW945R

■ Chapter Manual cleaning with ■ Disposable syringe 20 ml immersion disinfection ■ When cleaning instruments with mov-

e.g. GK469200

able hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning. medical compressed air

■ FW868R

■ Cleaning brush: 250 mm/∅ 3.7 mm, e.g. GK469200

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.

■ Drying phase: Use a lint-free cloth or Manual cleaning with ultrasound and immersion disinfection

infection procedure.

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ■ Disposable syringe 20 ml ultrasound and immersion dis■ Keep working ends open for cleaning. infection ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

■ Drying phase: Use a lint-free cloth or

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.8.2

Manual cleaning with ultrasound and immersion disinfection

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

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

-

-

-

-

medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ FW867R ■ FW945R

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

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline

■ Connect components with lumens and

cleaning and thermal disinfecting

channels directly to the rinsing port of the injector carriage.

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

■ Place the product on the tray with all product links and joints open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FW868R

■ Cleaning brush: 250 mm/∅ 3.7 mm, e.g. GK469200

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

■ Disposable syringe 20 ml ■ Chapter Manual pre-cleaning ■ When cleaning instruments with movwith ultrasound and brush able hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Chapter Mechanical alkaline

■ Place the product on a tray that is

cleaning and thermal disinfecting

suitable for cleaning (avoid rinsing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

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

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

3.8

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.

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.

3.9

Mechanical cleaning/disinfection

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

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]

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

3.11.1 Visual inspection

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).

3.9.1

3.11 Inspection

Water quality

Chemical/Note

3

D–W

-

10

FD-W

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

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

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

nical service.

3.11.2 Functional test

III

Intermediate rinse

>10/50

1

FD-W

-

► Assemble disassembled products, see Assembly. ► 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.

IV

Thermal disinfecting

90/194

5

FD-W

-

3.12 Assembly

V

Drying

-

-

-

According to the program for cleaning and disinfection device

■ working solution 0.5% – pH = 11*

DW: FD–W:

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

Note Account for the size of the implant when selecting the insertion instrument! ► Remove irrigation connector 4 from the handle end of insertion instrument 2. ► Verify that clamping sleeve 7 on insertion instrument 2 has been loosened. ► Turn clamping sleeve 7 counterclockwise until it is no longer in connection with connecting piece 8 of insertion

instrument 2. ► Connect the spacer 9 corresponding to the intraoperatively selected implant height to the insertion

instrument 2. ► Insert spacer 9 in the hole of the connecting piece, observing the "CRANIAL" and "CAUDAL" markings on the

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

3.10.1 Manual pre-cleaning with ultrasound and brush Phase

Step

D [°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

-

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.

3.10.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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 Note The product may only be sterilized in disassembled 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).

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

Step

3.13 Packaging

► Validated sterilization process

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

Phase

spacer 9 and insertion instrument 2. At the same time keep button 5, "push to clean", at the handle of insertion instrument 2 pressed down. ► Insert spacer 9 down to the stop in insertion instrument 2. ► Release "push to clean" button 5. By axially pulling at spacer 9, check that the spacer is properly locked in insertion instrument 2. ► Turn adjusting wheel 6 counterclockwise to set the depth stop to minimum insertion depth.

t [min]

Water quality

Chemical

3

D–W

-

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

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.

– Disassemble the product – 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 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. TA011997

2021-05

V6

Change No. AE0060911