Ennovate Cervical instruments for occipital fixation

en

Aesculap® Ennovate® Cervical Instruments for occipital fixation Legend

Contents

Instruments for occipital fixation - Straight instruments 1 Ennovate Cervical T-handle SZ004R 2 Ennovate Cervical occipital plate bender FW090R 3 Ennovate Cervical occipital plate holder SZ101R 4 Ennovate Cervical occipital drill ∅ 2.9 mm SZ102SU/SZ102R 5 Ennovate Cervical occipital drill ∅ 3.9 mm SZ103SU/SZ103R 6 Ennovate Cervical occipital tap ∅ 4.5 mm SZ104R 7 Ennovate Cervical occipital tap ∅ 5.5 mm SZ105R 8 Ennovate Cervical occipital drill/tap guide for 6 mm / 8 mm screws SZ106R 9 Ennovate Cervical occipital drill/tap guide for 10 mm / 12 mm screws SZ107R 10 Ennovate Cervical occipital drill/tap guide for 14 mm / 16 mm screws SZ108R 11 Ennovate Cervical occipital torque wrench SZ109R 12 Ennovate Cervical occipital counter torque wrench SZ110R 13 Ennovate Cervical occipital screwdriver SZ111R 14 Ennovate Cervical occipital screw remover SZ112R 15 Ennovate Cervical occipital screw remover shaft SZ113R

1. 1.1 1.2 2. 2.1 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 3. 3.1 3.2 3.3 3.4 3.5 3.5.1 3.5.2 3.6 3.6.1 3.6.2 3.7 3.7.1 3.7.2 3.8 3.9 3.9.1 3.9.2 3.10 3.11 3.11.1 3.11.2 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.7.3 4.7.4

Instruments for occipital fixation - Occipital Access instruments 16 Ennovate Cervical Occipital Access – drill/tap guide ∅ 4.5 mm SZ114R 17 Ennovate Cervical Occipital Access – drill/tap guide ∅ 5.5 mm SZ115R 18 Ennovate Cervical Occipital Access – angled gear instrument SZ116R 19 Ennovate Cervical Occipital Access – screwdriver bit SZ123SU 20 Ennovate Cervical Occipital Access – set of depth stops (6 mm to 16 mm) SZ119SU 21 Ennovate Cervical Occipital Access – bits for 4.5 mm screws (drill and tap bits) SZ120SU 22 Ennovate Cervical Occipital Access – bits for 5.5 mm screws (drill and tap bits) SZ121SU 23 Tubing clamp, serrated jaws AN912R The relative size of the instruments does not necessarily reflect their size in reality. The depictions in this document are schematic representations only and may deviate from the actual product.

2

About this document... Scope... Safety messages... Clinical use... Product description... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Safe application... Pre-operative planning... Verify size / contour plate... Place plate... Drill screw hole... Straight instruments... Occipital Access instruments... Cut thread with tap... Straight instruments... Occipital Access instruments... Insert and lock screw... Straight instruments... Occipital Access instruments... Insert rod... Insert set screw... Straight instruments... Occipital Access instruments... Tighten set screw... Remove implants... Remove occipital plate screws... Remove set screws and polyaxial screws... Validated reprocessing procedure... General safety instructions... General information... Single-use products... Reusable products... Preparations at the place of use... Preparing for cleaning... Disassembly... Ennovate Cervical occipital bender (FW090R)... Ennovate Cervical occipital torque wrench (SZ109R)... Plate holder (SZ101R)... Angled gear instrument (SZ116R)...

3 3 3 3 3 3 3 3 3 3 3 4 4 5 5 5 5 5 6 6 7 8 8 8 9 9 9 10 10 10 10 11 12 12 12 13 13 13 13 13 13 13 14 14 14 14 14

en 2.

Clinical use

2.1

Product description

4.8.2 4.9 4.9.1 4.9.2 4.10 4.10.1 4.11 4.11.1 4.11.2 4.11.3 4.12 4.12.1 4.12.2 4.13 4.13.1 4.13.2 4.13.3 4.13.4 4.14 4.15 4.16 5. 6. 7.

Cleaning/Disinfection... 14 Product-specific safety information on the reprocessing method... 14 Validated cleaning and disinfection procedure... 15 Manual cleaning/disinfection... 16 Manual cleaning with immersion disinfection... 16 Manual cleaning with ultrasound and immersion disinfection 17 Mechanical cleaning/disinfection... 18 Mechanical alkaline cleaning and thermal disinfecting... 18 Mechanical cleaning/disinfection with manual pre-cleaning . 19 Manual pre-cleaning with a brush... 19 Manual pre-cleaning with ultrasound and brush... 20 Mechanical alkaline cleaning and thermal disinfecting... 20 Inspection... 21 Visual inspection... 21 Functional test... 21 Assembly... 22 Ennovate Cervical occipital bender (FW090R)... 22 Ennovate Cervical occipital torque wrench (SZ109R)... 22 Plate holder (SZ101R)... 22 Angled gear instrument (SZ116R)... 22 Packaging... 23 Steam sterilization... 23 Storage... 23 Technical service... 23 Disposal... 23 Symbols on product and packaging... 23

1.

About this document

2.3

Safety information

2.3.1

Clinical user

4.8 4.8.1

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

1.1

Scope

These instructions for use apply to the Ennovate Cervical instruments for the occipital fixation. 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 mate-

rial 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.

Instruments for occipital fixation - Straight and Occipital Access instruments The surgical technique performed with the instruments for occipital fixation - Straight instruments is described in the sections entitled 'Straight instruments'. For patients with thoracic hunchback an angled gear instrument is available that can be used for drilling, tapping and screw insertion. An integrated pusher allows to transfer the energy to the working end so that the hole preparation and screw insertion work smoothly under difficult circumstances. The surgical technique is described below in the sections entitled ’Occipital Access instruments’.

2.2

Areas of use and limitations of use

2.2.1 Intended use The Ennovate Cervical instruments for occipital fixation are used for the implantation of Ennovate Cervical System occipital implants. The indications and contraindications are described in the Instruction for Use of the Ennovate Cervical implants TA015777. 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 Contraindications For contraindications, see Intended use.

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.

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged. 3

en 2.3.2

Product

Product-specific safety information These instructions for use only describe the specificities of the Ennovate Cervical occipital fixation. For information on the Ennovate Cervical system occipital implants and on the Ennovate Cervical basic technique, refer to the following documents:

Art. no.

Designation

SZ114R

Ennovate Cervical Occipital Access – drill/tap guide ∅ 4.5 mm

SZ115R

Ennovate Cervical Occipital Access – drill/tap guide ∅ 5.5 mm

Art. no.

Designation

SZ116R

TA015777

IFU ENNOVATE IMPLANT SYSTEM FOR POSTERIOR, OCCIPITAL, CERVICAL AND THORACIC STABILIZATION

Ennovate Cervical Occipital Access – angled gear instrument

AN912R

Tubing clamp, serrated jaws

TA015763

IFU ENNOVATE CERVICAL BASIC INSTRUMENTS

► Inspect the new product after removing its transport packaging and

TA015755

IFU ENNOVATE CERVICAL TRAYS

O03102

ENNOVATE CERVICAL - SURGICAL TECHNIQUE

O03202

ENNOVATE CERVICAL NAVIGATION - SURGICAL TECHNIQUE

prior to first use to ensure it is in good working order. The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Non-sterile, single-use products

► Only combine Aesculap products with each other.

Art. no.

Designation

► Observe the graphic/packing template when storing the instruments.

SZ102R

Ennovate Cervical occipital drill ∅ 2.9 mm

Instruments can fall in situ or on the floor! Handles can loosen during use! ► Check the seating of the coupling handles on the instruments for tightness.

SZ103R

Ennovate Cervical occipital drill ∅ 3.9 mm

► Only use Aesculap Ennovate instruments and accessories.

Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! ► Only carry out alignment and insertion of the instruments and polyaxial screws under radiographic control or with the aid of a navigation system.

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. ► Do not reuse the product. Sterile, single-use products Art. no.

Designation

Straight instruments 2.3.3

Sterility

Non-sterile, reusable products Art. no.

Designation

SZ102SU

Ennovate Cervical occipital drill ∅ 2.9 mm

SZ103SU

Ennovate Cervical occipital drill ∅ 3.9 mm

Occipital Access instruments

Straight instruments

SZ123SU

Ennovate Cervical Occipital Access - screwdriver bit

SZ004R

Ennovate Cervical T-handle

SZ119SU

FW090R

Ennovate Cervical occipital bender

Ennovate Cervical Occipital Access - set of depth stops (6 mm-16 mm)

SZ101R

Ennovate Cervical occipital plate holder

SZ120SU

SZ104R

Ennovate Cervical occipital tap ∅ 4.5 mm

Ennovate Cervical Occipital Access - bits for 4.5 mm screws (drill & tap bits)

Ennovate Cervical occipital tap ∅ 5.5 mm

SZ121SU

SZ105R

Ennovate Cervical Occipital Access - bits for 5.5 mm screws (drill & tap bits)

SZ106R

Ennovate Cervical occipital drill/tap guide for 6 mm / 8 mm screws

SZ107R

Ennovate Cervical occipital drill/tap guide for 10 mm / 12 mm screws

SZ108R

Ennovate Cervical occipital drill/tap guide for 14 mm / 16 mm screws

SZ109R

Ennovate Cervical occipital torque wrench

SZ110R

Ennovate Cervical occipital counter torque wrench

SZ111R

Ennovate Cervical occipital screwdriver

SZ112R

Ennovate Cervical occipital screw remover

SZ113R

Ennovate Cervical occipital screw remover shaft

Occipital Access instruments

4

The product has been sterilized by irradiation and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. ► 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.

en 3.

Application

Note All handles and handle surfaces are grey. All actuating elements that are actuated during the operation are gold colored. All torque wrench handles are purple.

3.1

a 2

Safe application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or missing components. ► Always carry out a function test prior to each use of the product. WARNING Risk of injury to patients due to damaged instruments! Ennovate Cervical instruments are precise and can be easily damaged. ► Handle Ennovate Cervical instruments with the greatest of care. ► Do not repair or modify the instruments (e.g. sharpening the tips). In case of malfunction send them to Aesculap Technical Service.

3.2

Pre-operative planning

To ensure a safe procedure, it is recommended to measure the thickness of the occipital bone with the help of a CT-scan or other suitable imaging types. The thickness determines the length of the occipital screws that will be implanted later.

3.3

Verify size / contour plate

DANGER Risk of injury due to damage/breakage of the plate if bent incorrectly! ► Only bend plate with provided bending pliers. ► Do not bend plate back. ► Avoid small bending radii, notching or scratching the plate.

b

c

Fig. 1 ► Contour the plate within the laser marked lines using the occipital

plate bender 2 (FW090R), see Fig. 1. – Insert the plate into the plate bender 2. Make sure it is well positioned (the protuberance a of the plate bender must be applied on the laser marked lines of the plate). – Press the handles b of the plate bender together to contour the plate. If needed, turn knob c to adjust the distance between the handles.

3.4

Place plate

A plate holder 3 (SZ101R) is available to facilitate the placement of the occipital plate. a a

CAUTION The plate cannot be firmly fixed in the plate holder if it is excessively bent. ► Do not bend the plate more than 15 degrees.

3

CAUTION A deformation of the holes may compromise a good locking of the screws within those holes. ► Do not deform the holes with the bending pliers. ► Make sure to bend the plate within the laser marked lines. ► Choose the plate size and design according to the anatomy of the

patient.

Fig. 2 ► Align the plate to plate holder 3 face down, so that the drill guide can

later be clipped into the plate holder, see Fig. 2. ► Snap in the lever arm a.

5

en 3.5

Drill screw hole

DANGER Risk of injury due to a hole that is too deep or too shallow! ► Do not sharpen the drill, otherwise the drill depth becomes inaccurate. ► Replace blunt drills with new ones. ► Check the depth of the occipital bone on pre-op images. ► Proceed with care to prevent damage to the dura. ► Always check the drill lengths with the guide sleeve being used: Insert the required drill into the guide up to the positive stop and verify the exposed length of the drill with a caliper. Note Drilling may be performed under radiographic control. DANGER Risk of injury due to a hole that is incorrectly placed or too deep! Risk of injury (instable plate) due to a hole that is not perpendicular to the plate. Revision required or operation delay if the hole is not aligned with the plate hole. ► Make sure to use the drill guide for drilling. DANGER Risk of injury and damage to the drill if the rotational speed is too high! ► Make sure to set an appropriate rotational speed for the intended application. Since the bone thickness is highest at the EOP (external occipital protuberance) it is recommended to place the first screw in the EOP at the midline of the occipital bone.

Note The drill/tap guides 8/9/10 (SZ106R/SZ107R/SZ108R) and 16/17 (SZ114R/SZ115R) can be clipped onto the plate holder 3 (SZ101R) at location a, so that it is easier to hold both the occipital plate holder and the occipital drill/tap guide with one hand. ► Use the sounder SZ066R to confirm the depth of the prepared hole.

3.5.1

Straight instruments

DANGER Risk of injury or damage to occipital bone (leading to poor screw anchorage) due to a hole that is too wide! ► Make sure to select the correct drill. Check the color coding. DANGER Risk of injury to the dura, nerve roots and blood vessels due to a hole that is too deep or too shallow! ► Make sure to select the correct drill/tap guide. Check the laser marking that indicates the drill depth on each guide. The positive stop of the drills are color-coded to match the color of the screw heads: ■ ∅ 2.9 mm drill 4 (SZ102SU/SZ102R) for ∅ 4.5 mm screws (gold) ■ ∅ 3.9 mm drill 5 (SZ103SU/SZ103R) for ∅ 5.5 mm screws (blue) The drill can be driven with a motor system and the Aesculap AO small drill attachment (GB623R). Three drill guides are available to cover the different drill depth. The two ends of the same guide cover different depth: ■ Drill/tap guide 8 (SZ106R) for 6 mm / 8 mm screws ■ Drill/tap guide 9 (SZ107R) for 10 mm / 12 mm screws ■ Drill/tap guide 10 (SZ108R) for 14 mm / 16 mm screws

Note It is recommended that the first hole is prepared (including tapping) and the first screw is inserted before the other screws are implanted. The first screw holds the plate in place while drilling and tapping the other holes. ► Always use the drill guide to drill holes. This ensures that the holes are

a

drilled at the correct location and to the correct depth. The guide also helps in aligning the drill perpendicular to the plate, which is necessary for a stable fixation of the plate.

3

4/5

a

16/17 8/9/10

8/9/10

Fig. 4

a 3

3

► Choose the guide according to the desired drill depth. ► Insert the required drill into the guide up to the positive stop and verify

the exposed length of the drill with a caliper (e.g. AA845R). ► Place the guide 8/9/10 on the plate holder 3, see Fig. 4. Make sure to

Fig. 3

6

place the guide with its groove facing upward (it can be used to slide the clamp of the plate holder into it). The teeth of the drill guide should come into contact with the bone. ► Insert the drill 4/5. Make sure that the drill is held perpendicular to the occipital plate. ► Drill until the depth stop is reached.

en 3.5.2

► Attach the motor system to the angled gear instrument 18 (SZ116R).

Occipital Access instruments

DANGER Risk of injury or damage to occipital bone (leading to poor screw anchorage) due to a hole that is too wide! ► Make sure to select the correct drill. Check the color coding (golden for ∅ 4.5 mm and blue for ∅ 5.5 mm). DANGER Revision required or operation delay if a hole is not centered! ► Make sure to use the drill end of the drill/tap guide for drilling. DANGER Risk of injury to the dura, nerve roots and blood vessels due to a hole that is too deep or too shallow! ► Make sure to use the correct depth stop. Check the laser marking that indicates the drill depth on each depth stop.

► Attach the drill bit 21/22 of the chosen size to the angled gear instru-

ment, see Fig. 5. Forceps can be used. Make sure the drill bit is fully inserted. ► Select the depth stop corresponding to the desired drill depth from the set of depth stops 20. Make sure to select the correct depth stop. Check the laser marking on the depth stops. ► Insert the depth stop over the bit. Check that it is not put on backwards. Forceps can be used to attach the stop to the angled gear instrument.

a 3 18

DANGER Risk of injury to the patient if the drill bit or depth stop are not attached properly! ► Make sure that the drill bit and the depth stop are attached properly. CAUTION Operation delay if the drill falls off the angled gear instrument! ► Make sure to keep the drill turning while removing it from the bone.

c 16/17 20 21/22 12 mm

Fig. 6 ► Choose the appropriate drill guide 16/17. Make sure that the drill end

of the drill/tap guide is used to help guiding the drill. ► Insert the required drill into the guide up to the positive stop and verify

CAUTION Operation delay! ► Reattach the drill to the angled gear instrument in case it gets stuck in the bone. Two drill bits and two drill guides are available:

■ Drill bit 21 (SZ120SU) and drill guide 16 (SZ114R) for ∅ 4.5 mm screws (gold)

■ Drill bit 22 (SZ121SU) and drill guide 17 (SZ115R) for ∅ 5.5 mm screws (blue) The drill/tap guides are double ended with one end for drilling and the other one for tapping. The drill can be driven with a motor system and an Aesculap hex drill attachment (e.g. GB886R). A set of depth stops 20 (SZ119SU) is available to cover the different drill depth. The depth stops are designed for drill depths from 6 mm to 16 mm.

the exposed length of the drill with a caliper (e.g. AA845R), as shown on the left side of the image, see Fig. 6. ► Place the guide 16/17 on the plate holder 3 (SZ101R). Make sure to place the guide with its groove facing upward (it can be used to slide the clamp of the plate holder into it). The teeth of the drill guide should come into contact with the bone. ► Adapt the angle of the handle b to optimize the transmitted force, see Fig. 5: – Turn the wheel c until the correct angle is reached. – Fix the wheel by turning it clockwise. ► Drill by actuating the motor system and applying force on the handle b. Make sure that the shaft a of the angled gear instrument is held parallel to the occipital plate, see Fig. 6.

18

21/22

b

20

18 c 20 21/22

Fig. 5 7

en 3.6

Cut thread with tap

DANGER Risk of injury due to a hole that is too wide (instable plate)! Revision required in case of screw loosening or bone breakage! Damage or breakage of instruments! ► Hold the screw tap axially to the prepared hole when turning in and out. Avoid levering, bending and strong applications of force while doing so. ► Make sure to use the correct tap size. Check the color coding and laser marking. DANGER Risk of injury due to an incorrectly placed hole or a hole that is too deep! Risk of injury (instable plate) due to a hole that is not perpendicular to the plate! Revision required or operation delay if the hole is not aligned with the plate! ► Make sure to use the tap guide for tapping. DANGER Risk of tissue injury or stripping bone threads when inserting tap! ► Always check that the tap advances correctly while applying the tap. DANGER Injury of the dura, nerve roots and blood vessels from a hole that is too deep, too shallow or misplaced! ► Make sure to select the correct tap guide. Check the laser marking that indicates the tapping depth on each guide. Always use the tap guide when tapping. This ensures that the hole is tapped at the correct location and to the correct depth. The guide also helps in aligning the tap perpendicular to the plate, which is necessary for a stable fixation of the plate. 3.6.1 Straight instruments The taps are color-coded to match the color of the screw heads: ■ Tap 6 (SZ104R) for ∅ 4.5 mm screws (gold) ■ Tap 7 (SZ105R) for ∅ 5.5 mm screws (blue)

The ratchet straight handle a (SZ001R) can be moved to the following positions by rotating the collar of the handle, as shown on the right side of the image, see Fig. 7: ■ Forward (IN): for tapping ■ Locked (•): blocks the ratchet ■ Reverse (OUT): for removing tap from the bone ► Leave the fixed occipital drill/tap guide 8/9/10 (SZ106R/SZ107R/SZ108R) in place for tapping the pre-drilled hole. ► Choose the appropriate tap. ► Attach the tap 6/7 to the ratchet straight handle a (SZ001R), as shown on the left side of the image, see Fig. 7: – Push the handle a onto the hex connection of the tap up to the stop. – Align the rotation setting 'IN' with the laser marked line (or keep it locked to block the ratchet). ► Position the tap on the previously prepared entry point and cut the thread by rotating clockwise to the required depth while maintaining the appropriate trajectory, as shown on the right side of the image, see Fig. 7. Make sure to hold the tap perpendicular to the occipital plate, see Drill screw hole. ► Align the rotation setting 'OUT' with the laser marked line (or keep it locked to block the ratchet). ► Unscrew the tap counter-clockwise. ► Loosen the tap from the handle by pulling on the black sleeve b. ► Remove the occipital drill/tap guide before placing the occipital screws. 3.6.2

Occipital Access instruments

DANGER Risk of injury to the dura, nerve roots and blood vessels due to a hole that is too deep or too shallow! ► Make sure to select the correct depth stop. Check the laser marking on the depth stop. ► Make sure that the depth CAUTION Delay of surgery if non-sufficient force is applied to be able to tap! ► Make sure to adapt the handle to optimize the transmitted force. The tap bits are color-coded to match the color of the screw heads: ■ Tap bit 21 (SZ120SU) for ∅ 4.5 mm screws (gold) ■ Tap bit 22 (SZ121SU) for ∅ 5.5 mm screws (blue)

a 8/9/10 b

18

6/7

21/22

20

6/7 a

16/17

3 1 b a

b

c

Fig. 7

Fig. 8

8

en ► Turn the drill/tap guide 16/17 (SZ114R/SZ115R) so that the tap side

connects to the occipital plate, as shown on the left side of the image, see Fig. 8. Make sure to place the guide with its groove facing upward (it can be used to slide the clamp of the plate holder into it). The teeth of the drill guide should come into contact with the bone. ► Choose the appropriate tap bit. ► Remove the depth stop 20 (SZ119SU) and the drill bit 21/22 by using the provided clamping forceps 23 (AN912R): – Clamp the drill with the forceps. – Pull on the forceps with one hand while pushing against the forceps with the thumb of the other hand holding the angled gear instrument 18. ► Attach the tap bit 21/22 and the depth stop 20 to the angled gear instrument, as shown at the top of the image, see Fig. 8 ► Adapt the angle of the handle b to optimize the transmitted force: turn the wheel c until the correct angle is reached. Fix the wheel by turning clockwise, as shown on the right side of the image, see Fig. 8. ► Tap by actuating the T-handle 1 (SZ004R) and applying force on the handle b, as shown on the right side of the image, see Fig. 8. Make sure that the shaft a of the angled gear instrument is held parallel to the occipital plate, see Drill screw hole.

3.7

Insert and lock screw

Since the bone thickness is highest at the EOP (external occipital protuberance) it is recommended to place the first screw in the EOP at the midline of the occipital bone. Two types of screws are available: ■ ∅ 4.5 mm screws (gold) ■ ∅ 5.5 mm screws (blue). These are backup or rescue screws for the golden ∅ 4.5 mm. The design of the screwdriver ensures that the screw is fixed and axially aligned to the screwdriver.

3.7.1

a b

CAUTION Operation delay if the screws are not inserted into the center of the plate holes. ► Always use a drill/tap guide to prepare the screw hole. Do not drill and tap without a guide.

3

13

13

Fig. 9 ► Attach the ratchet handle straight a (SZ001R) to the occipital

screwdriver 13 (SZ111R) by sliding the hexagonal portion of the driver shaft into the handle coupling b up to the stop. ► Align the rotation setting 'IN' with the laser marked line (or keep it locked to block the ratchet). ► Pick up the screw with the occipital screw driver 13, as shown on the left side of the image, see Fig. 9. ► Insert the occipital screws with the occipital screwdriver, as shown on the right side of the image, see Fig. 9. Make sure to hold the screwdriver perpendicular to the occipital plate. Visually check that the screw is fully seated. Locking the occipital screws firmly in the plate with the occipital screwdriver is sufficient. Do not overtighten the screws to prevent free spinning of the screws. 3.7.2

WARNING Risk of injury to the patient (instable plate/risk of loosening) or operation delay due to free spinning screws or from screws that are incorrectly inserted! ► Make sure that the screw is screwed in vertically into the plate. ► Insert the screw until it is fully seated. ► Visually check that the screw is fully seated. ► Do not overtighten the screws. CAUTION Operation delay! Damage to the screw if the screwdriver is not fully inserted into the screw. Torque cannot be transferred! ► Connect the screwdriver/screwdriver bit completely to the screw. ► Hold the screwdriver axially to the pre-prepared hole when turning in and out. Avoid levering, bending and strong applications of force when doing so.

Straight instruments

Occipital Access instruments 18 19

b

3

18 19

a a

19

Fig. 10 ► Remove the depth stop and the tap bit from the angled gear

instrument 18 (SZ116R) by using the provided clamping forceps 23, see Occipital Access instruments. ► Attach the screwdriver bit 19 (SZ123SU) and the corresponding occipital screw a as shown on the left side of the image, see Fig. 10. ► Insert the occipital screw a. Make sure that the shaft b of the angled gear instrument 18 is held parallel to the occipital plate. Visually check that the screw is fully seated. Locking the occipital screws firmly in the plate with the angled gear instrument and the screwdriver bit is sufficient. Do not overtighten the screws to prevent free spinning of the screws.

9

en ► When both center screws are placed, remove the plateholder 3

3.9.1

Straight instruments

(SZ101R). ► Place the remaining screws, see Drill screw hole, see Cut thread with tap.

3.8

Insert rod

CAUTION Operation delay! ► To avoid incorrect fixation of the set screw, make sure that the bend in the rod is not too close to the receptacles of the occipital plate.

12

a b

To connect the occipital plate to the cervical spine, pre-bent rods with ∅ 3.5 mm or ∅ 4.0 mm can be inserted into the rod receptacles. ► Insert the rod into the rod receptacles. The rods can be further bent and cut to fit the patient’s anatomy. Fig. 12 ► Start the set screw a in the threaded portion of the rod receptacles

using the set screw starter b (SZ069R/SZ068R), see Fig. 12. ► If needed, the occipital counter torque wrench 12 (SZ110R) or the rod

holding forceps (FW076R) can be used to persuade the rod and guide the set screw into the rod receptacles. 3.9.2

Occipital Access instruments

Fig. 11 For easier rod placement the rod receptacles allow translation and rotation, see Fig. 11. If needed, the rod holding forceps (FW076R) can be used to assist rod insertion. For further information on rod bending, rod cutting and rod insertion, refer to the instructions for use of the Ennovate Cervical basic instruments (TA015763).

3.9

19 a

Insert set screw

CAUTION Intraoperative revision required! Operation delay! Damage to the implant and instruments! ► Load the set screw correctly and completely with the set screw starter. ► Always place the set screw starter axially to the head of the polyaxial screw and do not tilt.

10

18

19 b

Fig. 13 ► Attach the set screw a to the screwdriver bit 19 (SZ123SU) of the

angled gear instrument 18 (SZ116R), see Fig. 13. ► Position the set screw in the threaded portion of the rod receptacles b,

see Fig. 13. If needed, the rod holding forceps (FW076R) can be used to persuade the rod and guide the set screw into the rod receptacles.

en 3.10 Tighten set screw This step is the same using the Straight instruments and Occipital Access instruments. It is imperative to use the counter torque wrench to prevent applying the torque directly to the patient’s spine and to ensure a perpendicular placement of the screwdriver, thus simplifying correct tightening of the set screw. DANGER Injury to patient from initiation of high torques on the spinal column! ► Always use the counter torque wrench 12 (SZ110R). ► Always completely and correctly insert the counter torque wrench 12 over the rod receptacle and check that it is fully seated on the rod. ► Hold the counter torque wrench 12 in position and do not twist or lever against the inserted rod. WARNING Risk of correction loss/insufficient stabilization of the spinal column region to be treated due to under tightening the set screw! ► Set the set screw in place correctly. ► Make sure that the rods are correctly positioned on the floor of the groove. ► Fully tighten the set screw, using the torque wrench 11 (SZ109R). WARNING Revision required due to damaged set screw! Risk of damage to the implant or instruments due to overtightening of the set screw! ► For final tightening of the set screws only use the 2.8 N∙m torque wrench 11. ► Check the recalibration/maintenance date on the torque wrench handle maintenance label prior to each use. ► When tightening or loosening the set screws, make certain that the star bit of the torque wrench is fully engaged in the socket of the set screws. ► Apply the torque slowly and without sudden movement until the torque wrench handle release is audibly triggered. WARNING Inadequate fixation or damage to implants due to introduction of lateral forces! ► When tightening or loosening, only subject the set screws to axial pressure. ► Avoid exerting lateral forces when tightening or loosening the set screws. WARNING Delay of surgery or risk of insufficient stabilization of the spinal column region to be treated due to damaged screw! ► Do not loosen and retighten the set screw more than 3 times.

12 11

Fig. 14 ► Make sure that the occipital torque wrench 11 (SZ109R) is correctly

mounted and that the star bit is firmly fixed. ► If not already in place, insert the counter torque wrench 12 (SZ110R) over the rod receptacle, see Fig. 14. ► Insert the occipital torque wrench 11 and turn evenly clockwise to tighten the set screw while holding the occipital counter torque wrench 12. Make sure to turn the torque wrench smoothly, without jerking. The torque wrench 11 will click when the defined torque (2.8 N∙m) is obtained. ► Do not move the torque wrench back counter-clockwise while it is still inserted in the set screw: if the defined torque is not obtained after turning the torque wrench one time in the clockwise direction, pull out the torque wrench 11 from the set screw, and insert it back at the position in which to start the second round of tightening in the clockwise direction.

Fig. 15 ► Visually double check that the set screw is fully seated, see Fig. 15.

The set screw is located below the top of the receptacle after final tightening when using a ∅ 3.5 mm rod, as shown on the left side of the image, see Fig. 15. The set screw is located plane with the top of the receptacle when using a ∅ 4 mm rod, as shown on the right side of the image, see Fig. 15.

CAUTION Damage to the counter torque wrench 12 due to improper usage! ► Always slide the counter torque wrench over the receptacle as far as it will go. When doing so, make sure that the implant entirely engages into the slot at the working tip. ► Make sure that the rod protrudes on both sides of the counter torque wrench.

11

en 3.11 Remove implants 3.11.1 Remove occipital plate screws

3.11.2 Remove set screws and polyaxial screws

DANGER Damage to the cortical occipital bone and/or occipital bone plate if the screw thread gets damaged during removal of the occipital plate screws! ► Always insert the screw removal shaft 15 fully in the thread of the occipital screw and through the screw remover 14 before unscrewing the screw with the screw remover.

DANGER Injury to patient from initiation of high torques on the spinal column! ► Always use the counter torque wrench 12. ► Always completely and correctly insert the counter torque over the rod receptacle and check that it is fully seated on the rod.

WARNING Remover shaft 15 breaks if excessive torque is applied! ► Do not apply excessive torque when screwing in the remover shaft. ► Do not apply additional torque once the shaft is fixed.

WARNING Delay of surgery or risk of insufficient stabilization due to damaged screw! ► Do not loosen and retighten the set screw more than 3 times. CAUTION Damage to the torque wrench 11! ► Do not apply excessive torque to loosen the screw. ► Loosen the set screw using the torque wrench 11 (SZ109R) and the

1

14

Fig. 16 ► Attach the screw remover 14 (SZ112R) to the T-handle 1 (SZ004R), see

Fig. 16. a

15

1

14

1

14

a

Fig. 17 ► Insert the screw remover 14 axially on the occipital screw, as shown at

the top of the image, see Fig. 17. ► Insert the removal shaft 15 (SZ113R) through the T-handle 1 and turn

the golden knob a clockwise until it is fixed, as shown at the top of the image, see Fig. 17. As soon as it is fixed, don’t apply any additional torque. ► Turn the T-handle 1 counter-clockwise to remove the screw, as shown at the bottom of the image, see Fig. 17. The screw removal shaft 15 applies tension on the screw to enable the barb under the screw head on the occipital screw to disengage the plate during removal.

12

counter torque wrench 12 (SZ110R) by turning the handle counterclockwise. ► Remove the polyaxial screws with the ball end screwdriver for polyaxial screws (SZ064R) or the Ennovate Cervical screwdriver for polyaxial screws (SZ063R) attached to the straight ratchet handle (SZ001R). Implant removal can result in complications due to stuck implants, ingrown bone tissue, etc. Such complications can lead to damage to implants and/or instruments. In case of complications when removing implant parts, use special instruments, such as the Cervical Revision set, which can be ordered from Aesculap.

en 4.

Validated reprocessing procedure

4.1

General safety instructions

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.

4.2

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 precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKIBrochures", "Red brochure".

4.3

Single-use products

For the list of single use products see Sterility. ► 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 sterile, single-use products. Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the drills with new gloves only. ► Keep the drill storage trays covered or closed. ► Process drill storage devices/trays separately from instrument trays. ► Clean drills must not be cleaned together with contaminated drills. ► Reprocess the drills individually and separately if no implant system storage devices are available, When doing this, make certain that the implant components are not damaged. ► Do not reuse surgically contaminated drills.

4.4

Reusable products

For the list of instruments that can be reused and must be sterilized prior to each use see Sterility. There is no set maximum number of uses and reprocessing cycles for the product. The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling, storage and transport of the product. 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.

4.5

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.

4.6

Preparing for cleaning

► Do not disassemble fixation screws which permanently connect the

various components. ► Disassemble the product prior to cleaning, see Disassembly. ► Open up product with hinges.

13

en 4.7

Disassembly

4.7.1

Ennovate Cervical occipital bender (FW090R)

4.7.4

Angled gear instrument (SZ116R)

a c

b

Fig. 18

Fig. 21

► Loosen the knob a and turn the thread counter-clockwise until the

► Loosen the golden wheel c by turning it counter-clockwise.

knob is completely removed, see Fig. 18. 4.7.2

a

► Turn the nut a counter-clockwise and remove it with the shaft b. Take

care not to lose the nut a.

Ennovate Cervical occipital torque wrench (SZ109R) c

c

4.8

Cleaning/Disinfection

4.8.1

a

Product-specific safety information on the reprocessing method Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastics and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

b

► Use suitable cleaning/disinfecting agents if the product is disposed of

Fig. 19 ► Unscrew the thumb screw c from the rear of the wrench head, as

shown on the left side of the image, see Fig. 19. ► Remove the star bit a from the inner surface of the wrench head, as

shown on the right side of the image, see Fig. 19. The inner surface of the torque wrench can be identified by the two integrated screws b. ► Take care not to lose the star bit a and the thumb screw c. 4.7.3

Plate holder (SZ101R)

c

Fig. 20 ► Push the lever c all the way back, see Fig. 20.

14

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 ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement). ► If the 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.

en 4.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth or medical compressed air

Chapter Manual cleaning/disinfection and subsection:

■ AN912R ■ SZ101R to SZ116R Manual cleaning with ultrasound and immersion disinfection

■ FW090R ■ SZ004R

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth or medical compressed air

■ Chapter Manual cleaning with immersion disinfection Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that is suitable for cleaning (avoiding rins- Chapter Mechanical cleaning/disinfection and

■ AN912R ■ SZ101R to SZ105R ■ SZ109R ■ SZ111R ■ SZ113R

■ Place products in the tray with their hinges open.

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

Chapter Mechanical cleaning/disinfection ■ Suitable cleaning brush with manual pre-cleaning and subsection: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with a brush ■ Place the product in a tray that is suitable for cleaning (avoiding rins■ Chapter Mechanical alkaline cleaning and ing blind spots).

■ SZ106R to SZ108R ■ SZ110R ■ SZ112R ■ SZ114R to SZ116R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FW090R ■ SZ004R

ing blind spots).

■ Place products in the tray with their hinges open. ■ SZ116R: Connect components with lumens and channels directly to

subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

thermal disinfecting

the rinsing port of the injector carriage. Chapter Mechanical cleaning/disinfection ■ 20 ml disposable syringe with manual pre-cleaning and subsection: ■ Place the product in a tray that is suitable for cleaning (avoiding rins■ Chapter Manual pre-cleaning with ultraing blind spots). sound and brush

■ Place products in the tray with their hinges open. ■ Chapter Mechanical alkaline cleaning and ■ SZ004R: Rinse lumens using spray nozzle (3.8 bar water pressure) at thermal disinfecting least 3 times for 20 seconds each.

■ SZ004R: Connect components with lumens and channels directly to the rinsing port of the injector carriage.

15

en 4.9

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning/disinfection process if necessary.

4.9.1

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, 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 disinfection 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 run-

ning 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.

16

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.

en 4.9.2

Manual cleaning with ultrasound and immersion disinfection

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

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, 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 disinfection 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 run-

ning 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 run-

ning 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.

17

en 4.10 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. 4.10.1 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

DW: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

18

en 4.11 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. 4.11.1 Manual pre-cleaning with a brush 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

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection 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 run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing.

19

en 4.11.2 Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection 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 run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. 4.11.3 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfecting machine 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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

20