activC handle, reamer guide, chisel guide, trial implants

2.2

Areas of use and limitations of use

Aesculap activC® handle, reamer guide, chisel guide, trial implants

2.2.1

Intended use

Legend

2.2.2

1 Trial implant 2 Handle 3 Reamer guide 4 Mounting block (for reamer guide) 5 Reamer 6 Reamer handpiece 7 HiLAN pneumatic motor 8 activC chisel insert 9 Chisel holder 10 Chisel guide 11 Locking pipes 12 Adjusting wheel 13 Locking clip

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

en ®

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 activC handle, reamer guide, chisel guide and trial implants. ► 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. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

The trial implants are used in conjunction with the handpiece to verify the size, height and shape of the activC intervertebral disk prosthesis to be implanted, and in conjunction with the reamer guide or the chisel guide to prepare the fin bed for the inferior implant plate of the activC intervertebral disk prosthesis.

Indications

For indications, see Intended use.

2.2.3

Contraindications

No known contraindications.

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. 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.

2.3.2

Product

Product-specific safety information Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

2.

Clinical use

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

2.1

Available sizes

► Only combine Aesculap products with each other. ► Always adhere to applicable standards. ► To prevent damage at the working end: carefully insert the product through the working channel (e.g. trocar). ► Only use the product under vision.

Art. no.

Designation 1

Trial implant size XS, H5

FW790R1

Trial implant size XS, H6

FW791R1

Trial implant size S, H5

FW792R1

Trial implant size S, H6

FW793R1

Trial implant size M, H5

FW794R1

Trial implant size M, H6

FW795R1

Trial implant size L, H5

FW796R1

Trial implant size L, H6

FW797R1

Trial implant size XL, H5

FW798R1

Trial implant size XL, H6

FW799R1

Trial implant size XXL, H5

FW800R1

Trial implant size XXL, H6

FW87011

Handle

FW871R2

Reamer guide (with mounting block)

GB771R2

Hi-Line XS handpiece angled XL-I

GE700SU4

Hi-Line XS activC drill XL-I D1, 5

FW784R3

activC chisel guide

FW786R3

activC chisel holder

FW787R4

activC chisels

FW789R

1

knowledge, or experience.

Trays FW645R and FW647R

2 only tray FW647R 3 only tray FW645R 4 single-use products

2.3.3

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile products Art. no.

Designation

GE700SU

Hi-Line XS activC drill XL-I D1, 5

FW787R

activC Chisels

The product has been gamma-sterilized and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. Single-use products The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

2.4

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. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. Note Follow OP-Manual no. O31302 and instructions for use "activC intervertebral disk prosthesis", see TA011995.

2.4.1

Mounting the trial implant of the selected size on the handle

► Turn locking pipes 11 of handle 2 to “open” position , see Fig. 1. ► Mount the trial implant with the selected size, height and shape onto the handle 2. Note the "CRANIAL" and

"CAUDAL" markings on the handle and on the trial implant. .

► Turn locking pipes 11 of handle 2 to "closed" position ► Check the trial implant for firm seating.

WARNING Compression of the spinal canal and of other posterior elements caused by trial implants inserted too deeply! ► Prior to insertion of trial implants, adjust the depth stop to minimum insertion depth. ► Insert trial implants in the intervertebral space under X-ray control. ► Use adjusting wheel 12 to set the depth stop of the trial implant to minimum insertion depth. ► Insert the trial implant in the intervertebral space under X-ray control. Ensure correct cranial and caudal align-

ment of the trial implant. ► Align the markings of the trial implant center to the midline marking. ► If necessary, correct the position of the depth stop with adjusting wheel 12 until the intended position is reached.

Ensure that depth stop abuts to the anterior edge of the vertebral body.

WARNING Increased risk of migration if the selected implant size is too small! ► Select the trial implant or implant size, respectively, to achieve maximum coverage of the vertebral body endplates. ► On the X-ray, in AP and lateral view, check to ensure that the size, position and alignment of the trial implant are correct. WARNING Irritation of the facet joints and strain on spinal cord and nerve roots due to excessive or insufficient distraction! ► Select the correct trial implant/ implant height. ► Check for correct height of the trial implant in a lateral X-ray. ► On the intraoperative X-ray image, in AP and lateral view, check the size, height and position of the trial implant. ► With the trial implant properly positioned, turn locking pipes 11 to "open" position and pull off handle 2 care-

fully in axial direction from the trial implant. The trial implant remains in the intervertebral space.

► To ream the first hole under lateral X-ray control: With the motor running, push reamer handpiece 6 at an even

speed and with mild forward pressure into the first guiding slot down to the stop. ► Pull back reamer handpiece 6 and, after moving the pins of mounting block 4 in the second guiding slot, repeat

the reaming procedure under lateral X-ray control. The reaming depth will be limited by the stop on the reamer guide 3. ► With the hand control not actuated, shift the safety stop on the pneumatic motor to position "0". ► Cautiously pull out reamer handpiece 6 first from the rear and then from the front reamer guide 3. ► Remove reamer guide 3 and the trial implant from the vertebral disk space. Clean the fin bed with nerve hooks from the discectomy set.

2.4.3

Chiseling the fin bed

Assembling the chisel guide Note The handle and the chisel guide are fitted with identical locking mechanisms. ► Turn locking pipes 11 of chisel guide 10 to "open" position . ► Mount the chisel guide 10 onto the trial implant in the intervertebral space. Note the "CRANIAL" and "CAUDAL"

markings on the handle and on the trial implant.

Note The fin bed can either by prepared by reaming or chiseling. This can be carried out either with the reamer guide with handpiece or the chisel guide with chisel holder, depending on which set is used.

► Turn locking pipes 11 of chisel guide 10 to "closed" position

2.4.2

WARNING Damage to nerves, spinal cord and other tissue because of fin bed reamed too deeply due to using too long a chisel. ► Only use chisel holder FW786R. ► Only use chisel FW787R.

Fin bed reaming

Assembling the reamer guide Note The handle and the reamer guide are fitted with identical locking mechanisms. ► Turn locking pipes 11 of reamer guide 3 to "open" position . ► Mount the reamer guide 3 onto the trial implant in the intervertebral space. Note the "CRANIAL" and "CAUDAL"

markings on the reamer guide and on the trial implant. ► Turn locking pipes 11 of reamer guide 3 to "closed" position . Reamer guide 3 is fixed to the trial implant. ► Check again, by X-ray imaging, the position of the trial implant.

► Mount the chisel onto the chisel holder 9, see Fig. 6. ► To do this mount the chisel sideways onto the chisel holder and push it backwards until it engages. Pull at the

chisel, to check that it is engaged properly.

Assembling the reamer handpiece WARNING Damage to nerves, spinal cord and other tissue because of fin bed reamed too deeply due to using too long a reamer handpiece or reamer! ► Only use reamer handpiece Hi-Line XS XL-1 (GB771R). ► Only use activC reamer (GE700SU). ► Prior to mounting, verify that the safety stop of the pneumatic motor is in position "0". ► Assemble the compressed-air tube, the HiLAN pneumatic motor and reamer handpiece 6 as described and illus-

trated in the respective instructions for use, see Fig. 2. ► Hold locking clip 13 of mounting block 4 pressed down and push the mounting block over the reamer

handpiece 6, see Fig. 3. ► Slide on mounting block 4 as far as it will go and release locking clip 13, see Fig. 4. ► Pull at the mounting block 4 to check whether it is engaged properly. The arrow marking on the locking clip 13

must point to the "closed" pictogram. ► Mount reamer 5 as described in the instructions for use of reamer handpiece 6. WARNING Risk of injury to blood vessels, nerves, spinal cord or other tissue if wrong reamer is used! ► Only use the activC reamer GE700SU. ► Check for technical faults prior to use. ► Do not use bent reamers. ► Do not reuse reamers after first use. DANGER Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product. Note The reaming of the fin bed determines the position and orientation of the disk prosthesis in the plane of the intervertebral disk. The fin bed must only be prepared for the inferior implant plate. WARNING Malpositioning of the intervertebral disk prosthesis due to failure to observe the midline! ► Check the central position of the trial implant by means of the midline marking and on the AP-view Xray image. ► Make certain that the position of the trial implant does not change during reaming. WARNING Risk of injury caused by sharp chisel! ► To avoid injuries to critical blood vessels, nerves and other tissue, as well as injuries to the operating surgeon, always work with appropriate care when a reamer is clamped in the machine. ► Do not activate the motor before the handpiece with the coupled reamer is properly positioned in the guide hole and the guiding slot of the reamer guide. ► A: Insert the reamer handpiece 6 with the reamer clamped in into the front guide hole of the reamer guide 3,

see Fig. 5. ► B: Insert the laterally protruding pins of the mounting block 4 into the rear guide slots of the reamer guide 3, see Fig. 5. ► With the hand control not actuated, push the safety stop to

. Chisel guide 10 is fixed to the trial implant. ► Check again, by X-ray imaging, the position of the trial implant.

.

The system is ready for operation. Note The reaming of the fin bed determines the position and orientation of the disk prosthesis in the plane of the intervertebral disk. WARNING Malpositioning of the intervertebral disk prosthesis due to failure to observe the midline! ► Check the central position of the trial implant by means of the midline marking and on the AP-view Xray image. ► Make certain that the position of the trial implant does not change during reaming. WARNING Risk of injury to nerves and spinal cord caused by too deep insertion of the reamer! ► Use activC instruments only. ► Use the instruments according to their intended use. ► For reaming the holes, apply the reamer only in combination with a correctly selected and positioned trial implant and with the reamer guide coupled. ► Take care that the depth stop of the trial implant abuts the anterior edge of the vertebral body. ► Always maintain lateral X-ray control while reaming the holes.

WARNING Risk of injury to blood vessels, nerves, spinal cord or other tissue if wrong chisel is used! ► Only use chisel FW787R. ► Do not use bent chisels. Do not reuse chisels after first use. Note The chiseling of the fin bed determines the position and orientation of the disk prosthesis in the plane of the intervertebral disk. The fin bed must only be prepared for the inferior implant plate. WARNING Malpositioning of the intervertebral disk prosthesis due to failure to observe the midline! ► Check the central position of the trial implant by means of the midline marking and on the AP-view Xray image. ► Make certain that the position of the trial implant does not change during reaming. WARNING Risk of injury caused by sharp chisel! ► To avoid injuries to critical blood vessels, nerves and other tissue, as well as injuries to the operating surgeon, always work with appropriate care when a chisel is clamped in the chisel holder. ► A: Carefully push the chisel holder 9 with the chisel through the rear chisel guide, see Fig. 7. ► B: Carefully push the chisel holder 9 with the chisel through the front chisel guide, see Fig. 7.

Note The chiseling of the fin bed determines the position and orientation of the disk prosthesis in the plane of the intervertebral disk. WARNING Malpositioning of the intervertebral disk prosthesis due to failure to observe the midline! ► Check the central position of the trial implant by means of the midline marking and on the AP-view Xray image. ► Make certain that the position of the trial implant does not change during chiseling. WARNING Risk of injury to nerves and spinal cord caused by too deep insertion of the reamer! ► Use activC instruments only. ► Use the instruments according to their intended use. ► Only use the fin in combination with a correctly selected and positioned trial implant and with the chisel guide coupled. ► Take care that the depth stop of the trial implant abuts the anterior edge of the vertebral body. ► Always maintain lateral X-ray control while chiseling the fin. ► Carefully mount the chisel guide with chisel on the vertebral body. ► With slight pressure and at an even speed, chisel under lateral X-ray control. The chiseling depth is limited by

the stop on the chisel guide 10. ► Carefully pull the chisel backwards out of the chisel guide. ► Remove chisel guide 10 and the trial implant from the vertebral disk space. ► Clean the fin bed with nerve hooks from the discectomy set.

3.

Validated reprocessing procedure

3.1

Single-use products

Art. no.

Designation

GE700SU

Hi-Line XS activC drill XL-I D1, 5

FW787R

activC chisels

► Do not reuse the product.

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

3.2

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.

3.3

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.

3.4

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.

3.5

Disassembly

3.7

3.5.1

Uncoupling the reamer guide/handle from the trial implant

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

infecting solution.

► Turn locking pipes 11 of reamer guide 3 or of handle 2 to "open" position . ► Pull off the trial implant in axial direction. ► Decouple reamer 5 from reamer handpiece 6 as described in instructions for use TA011267.

3.5.2

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

Detaching the mounting block from the reamer handpiece

► Hold locking clip 13 of mounting block 4 pressed down (arrow marking points to "open" position

) and pull off

the mounting block from reamer handpiece 6.

3.5.3

Uncoupling the chisel guide/handle from the trial implant

► Turn locking pipes 11 of chisel guide 10 or of handle 2 to "open" position ► Pull off the trial implant in axial direction. ► Raise the chisel by the tip on the instrument and push out forwards.

.

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 example aluminum, plastic materials, and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water

3.6.2

Validated cleaning and disinfection procedure

Validated procedure Manual cleaning with immersion disinfection

■ FW786R

Specific requirements

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

■ FW789R–FW800R ■ FW870 ■ FW871R ■ FW784R

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

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with immersion disinfection

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ FW789R–FW800R: Clean

■ Drying phase: Use a lint-free

■ FW786R

is suitable for cleaning (avoid rinsing blind spots).

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: FD–W: RT: *Recommended:

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature BBraun Stabimed fresh

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

cloth or medical compressed air

■ Place the product on a tray that

Phase

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.

reamer guide 3, chisel guide 10 and handle 2 with locking pipes 11 in closed position ( ) and do not move them during cleaning.

Mechanical alkaline cleaning and thermal disinfection

Manual cleaning with immersion disinfection

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

cloth or medical compressed air

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ When cleaning instruments

3.7.1

Reference

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

Manual cleaning/disinfection

Chapter Mechanical cleaning/disinfection and subsection:

3.7.2

Manual cleaning with ultrasound and immersion disinfection

■ Chapter Mechanical alkaline

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

-

-

-

-

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

■ FW789R–FW800R ■ FW870 ■ FW871R ■ FW784R

■ Cleaning brush: TA011944 ■ Disposable syringe 20 ml ■ Place the product on a tray that

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

is suitable for cleaning (avoid rinsing blind spots).

with ultrasound and brush

■ 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.

■ Chapter Manual pre-cleaning ■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Keep working ends open for cleaning.

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

■ Clean reamer guide 3, chisel guide 10 and handle 2 with locking pipes 11 in closed position ( ) and do not move them during cleaning.

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.

3.9.2

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

3.8

Mechanical 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:

Mechanical cleaning/disinfection

– pH = 13 – <5 % anionic surfactant

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.8.1

Mechanical alkaline cleaning and thermal disinfecting

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

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

– 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:

– 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

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

DW: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.9

■ working solution 0.5%

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.

3.9.1

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

-

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.

3.10.2 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. ► 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 Packaging

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

► 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.

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

3.12 Steam sterilization

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.

Note The product may only be sterilized in disassembled condition. Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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

– 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.

3.13 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Store sterile single-use products in germ-proof packaging in a dust-protected, dry, dark and temperature-con-

trolled room.

3.13.1 Ambient conditions The following environmental conditions apply to the transport and storage of the product: Temperature

-10 °C to 50 °C

Relative humidity

10 % to 90 %

Atmospheric pressure

500 hPa to 1 060 hPa

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.

6.

Symbols on product and packaging "Closed" position

"Open" position

Ready

TA011996

2020-07

V6

Change No. 62347