Ennovate Cervical MIS instruments

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16c

16a 16

16b

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Aesculap® Ennovate® Cervical MIS instruments Legend Ennovate Cervical set MIS 1 Ennovate Cervical MIS dilator handle (SZ145R) 2 Ennovate Cervical drill cannulated ∅ 2.3 mm (SZ013SU/SZ013R) 3 Ennovate Cervical drill cannulated ∅ 2.8 mm (SZ014SU/SZ014R) 4 Ennovate Cervical drill cannulated ∅ 3.3 mm (SZ015SU/SZ015R) 5 Ennovate Cervical MIS obturator for universal drill guide (SZ144R) 6 Ennovate Cervical MIS and C1/C2 K-wire long ∅ 1.5 mm (SZ137SU/SZ137R) 7 Ennovate Cervical MIS K-wire long ∅ 1.0 mm (SZ158SU/SZ158R) 8 Ennovate Cervical MIS dilator small (SZ146R) 9 Ennovate Cervical MIS dilator large (SZ147R) 10 Ennovate Cervical MIS counter torque (SZ148R) 11 Ennovate Cervical MIS extended tab sleeve for MIS screw (SZ149R) 12 Ennovate Cervical MIS screwdriver (SZ150R) 13 Ennovate Cervical MIS rod inserter (SZ151R) 14 Ennovate Cervical MIS tab breaker (SZ153R) 15 Ennovate Cervical MIS drill removal tool (SZ157R) 16 Ennovate Cervical MIS universal drill guide (inclusive 3.5 mm / 3.6 mm and 4.0 mm tube) (SZ143R) consisting of: 16a Drill guide body 16b Drill guide 3.5 mm / 3.6 mm tube 16c Drill guide 4.0 mm tube 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.

Contents 1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 3. 3.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4

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About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Safe application... MIS streamlined workflow... Prepare MIS universal drill guide 16 (SZ143R)... Insert MIS universal drill guide... Open cortex: create pilot hole... Drill hole...

3 3 3 3 3 3 3 3 3 3 4 4 5 5 5 5 6 6 7

3.2.5 3.2.6 3.2.7 3.2.8 3.2.9 3.2.10 3.2.11 3.2.12 3.2.13 3.2.14 3.2.15 3.2.16 3.2.17 3.3 3.3.1 3.3.2 3.3.3 3.3.4 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.7.3 4.8 4.8.1 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

Remove drill guide body... 7 Insert dilators... 7 Remove drill... 8 Insert K-Wire... 8 Remove small dilator and drill tube... 8 Cut thread with tap (optional)... 8 Prepare screw... 8 Perform navigated screw placement... 9 Prepare rod... 9 Insert rod... 9 Insert set screw... 10 Tighten set screw... 10 Remove long tabs... 10 MIS extended workflow... 11 Insert K-wire into the drill removal tool... 11 Insert drill removal tool... 11 Align K-wire to the drill tip... 11 Remove drill... 12 Validated reprocessing procedure... 12 General safety instructions... 12 General information... 12 Single-use products... 13 Reusable products... 13 Preparations at the place of use... 13 Preparing for cleaning... 13 Disassembly... 13 MIS universal drill guide (SZ143R)... 13 MIS rod inserter (SZ151R)... 13 Drill removal tool (SZ157R)... 13 Cleaning/Disinfection... 14 Product-specific safety information on the reprocessing method... 14 Validated cleaning and disinfection procedure... 14 Manual cleaning/disinfection... 15 Manual cleaning with immersion disinfection... 15 Manual cleaning with ultrasound and immersion disinfection 16 Mechanical cleaning/disinfection... 17 Mechanical alkaline cleaning and thermal disinfecting... 17 Mechanical cleaning/disinfection with manual pre-cleaning. 18 Manual pre-cleaning with a brush... 18 Manual pre-cleaning with ultrasound and brush... 19 Mechanical alkaline cleaning and thermal disinfecting... 19 Inspection... 20 Visual inspection... 20 Functional test... 20 Assembly... 20 MIS universal drill guide (SZ143R)... 20 MIS rod inserter (SZ151R)... 20 Drill removal tool (SZ157R)... 20

en 4.14 4.15 4.16 5. 6. 7.

Packaging... Steam sterilization... Storage... Technical service... Disposal... Symbols on product and packaging...

1.

About this document

21 21 21 21 21 21

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1 Intended use The Ennovate Cervical MIS instruments are used for the minimally invasive implantation of Ennovate Cervical system implants. The indications and contraindications are described in the instruction for use of the Ennovate Cervical implants (TA015777).

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

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

1.1

For indications, see Chapter 2.1.1.

Scope

These instructions for use are limited to the specificities of the MIS technique and apply only to the instruments listed on the foldout page. 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. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.1.3 Contraindications For contraindications, see Chapter 2.1.1.

2.2

Safety information

2.2.1

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.

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Product

2.2.3

Sterility

Product-specific safety information These instructions for use are limited to the specificities of Ennovate Cervical MIS instruments. Several steps are described in the instructions for use for the basic technique. The MIS technique is always performed with the Brainlab navigation system. Refer to the operating manual and instructions for use dedicated to navigation. Refer to the following documents:

Non-sterile, reusable products

Art. no. TA015777

Art. no.

Designation

SZ145R

Ennovate Cervical MIS dilator handle

SZ144R

Ennovate Cervical MIS obturator for universal drill guide

SZ146R

Ennovate Cervical MIS dilator small

Designation

SZ147R

Ennovate Cervical MIS dilator large

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

SZ148R

Ennovate Cervical MIS counter torque

SZ149R

Ennovate Cervical MIS extended tab sleeve for MIS screw

SZ150R

Ennovate Cervical MIS screwdriver

SZ151R

Ennovate Cervical MIS rod inserter

SZ153R

Ennovate Cervical MIS tab breaker

SZ157R

Ennovate Cervical MIS drill removal tool

SZ143R

Ennovate Cervical MIS universal drill guide

TA015763

IFU ENNOVATE CERVICAL BASIC INSTRUMENTS

TA015762

IFU ENNOVATE CERVICAL NAVIGATED INSTRUMENTS

TA015755

IFU ENNOVATE CERVICAL TRAYS

O03102

ENNOVATE CERVICAL - SURGICAL TECHNIQUE

O03202

ENNOVATE CERVICAL NAVIGATION - SURGICAL TECHNIQUE

O03302

ENNOVATE CERVICAL MIS - SURGICAL TECHNIQUE

► Only combine Aesculap products with each other. ► Only use Aesculap Ennovate instruments and accessories. ► When disposing of or recycling the product, ensure that the pack-

aging prevents injury by the product. ► Observe the graphic/packing template when storing the instruments. ► Use the product only in applications according to its intended use, see

Chapter 2.1.1. 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. Injury of spinal cord, nerve roots and blood vessels due to piercing of the cortex in case of incorrect application! ► Only carry out alignment and insertion of the instruments and polyaxial screws with the aid of a navigation system.

► Inspect the new product after removing its transport packaging and

prior to first use to ensure it is in good working order. The product is delivered in a non-sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Non-sterile, single-use products Art. no.

Designation

SZ013R

Ennovate Cervical drill cannulated ∅ 2.3 mm

SZ014R

Ennovate Cervical drill cannulated ∅ 2.8 mm

SZ015R

Ennovate Cervical drill cannulated ∅ 3.3 mm

SZ137R

Ennovate Cervical MIS and C1/C2 K-wire long ∅ 1.5 mm

SZ158R

Ennovate Cervical MIS K-wire long ∅ 1.0 mm

The product is delivered in a non-sterile 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

SZ013SU

Ennovate Cervical drill cannulated ∅ 2.3 mm

SZ014SU

Ennovate Cervical drill cannulated ∅ 2.8 mm

SZ015SU

Ennovate Cervical drill cannulated ∅ 3.3 mm

SZ137SU

Ennovate Cervical MIS and C1/C2 K-wire long ∅ 1.5 mm

SZ158SU

Ennovate Cervical MIS K-wire long ∅ 1.0 mm

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.

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Application

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

3.2

3.1

3.2.1 Prepare MIS universal drill guide 16 (SZ143R) The tubes and the positive stop of the drills are color-coded to match the color of the screw heads: ■ ∅ 3.5 mm / 3.6 mm tube 16b and ∅ 2.3 mm drill 2 (SZ013SU/SZ013R) for ∅ 3.5 mm / 3.6 mm polyaxial screws (silver). ■ ∅ 4.0 mm tube 16c and ∅ 2.8 mm drill 3 (SZ014SU/SZ014R) for ∅ 4.0 mm polyaxial screws (gold). ■ ∅ 4.5 mm tube (SZ058R) and ∅ 3.3 mm drill 4 (SZ015SU/SZ015R) for ∅ 4.5 mm polyaxial screws (green)

Safe application

When using K-wires, observe the following two warning notices:

MIS streamlined workflow

For patient registration, navigation set-up and instrument calibration refer to the IFU for Ennovate Cervical navigated instruments (TA015762).

DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing of the cortex in the case of incorrect application! ► Only carry out the alignment and insertion of the instruments, Kwires and polyaxial screws under radiographic control or with the aid of a navigation system. ► Carefully guide the instruments over the K-wire. When doing this, make sure that the K-wire remains in its position. It is recommended to hold the K-wire and to check the striped marking on the K-wire. ► Do not bend K-wires. Immediately replace bent K-wires. ► Inspect the cannulation of the instruments for blockage before every application.

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling the holes! ► Always use the correct Ennovate Cervical drill guides when drilling holes. ► Do not combine drills and guides incorrectly.

DANGER Injury of spinal cord, nerve roots and blood vessels due to bent K-wires or K-wires not holding in the bone! ► Do not reuse K-wires. ► Carefully drive in K-wires. ► Do not bend K-wires. Immediately replace bent K-wires. ► Insert the K-wires in the correct direction, with the roughened end pointing forward. ► Only use K-wires SZ137SU/SZ137R, SZ158SU/SZ158R of the Ennovate Cervical system.

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole that is too deep or too shallow. ► Use an appropriate imaging technique to select an appropriate drill length prior to the operation. ► Align and insert the drills only under radiographic monitoring and/or aided by a navigation system. ► Select a drill of a length equivalent to the intended drill hole depth. ► Always check the drill length with a caliper before starting to drill. ► Check the laser marking on the drill guide.

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.

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole of an inaccurate size! ► Make sure to attach the appropriate drill tube. Check the color coding and laser marking. ► Make sure to use the right drill. Check the color coding and laser marking.

WARNING Risk of injury to the 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 of the tips). In case of malfunction send them to Aesculap Technical Service.

DANGER Risk of injury and damage to the drill if the rotational speed is too high! ► Make sure to set a rotational speed appropriate for the intended application. WARNING Risk of revision due to instable fixation or damage to the bone! Damage to the implant or instrument! Prepared hole is too shallow! ► Do not sharpen the drill, as this makes the reading on the depth gauge inaccurate and falsifies the reading. ► Replace blunt drills with new ones.

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16b/16c

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16 e

5 5

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5 16a

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16

b d

c

b d

16

Fig. 1

Fig. 2

► Select the appropriate drill guide tube 16b/16c or ∅ 4.5 mm

► Introduce the MIS obturator 5 (SZ144R) into the MIS universal drill

tube SZ058R. ► Attach the tube to the drill guide body 16a, see Fig. 1. ► Select the appropriate drill 2/3/4. ► Set the desired depth on the MIS universal drill guide 16 (SZ143R): hold down the golden square button d and adjust the depth stop e to the desired position. Release the golden button d to lock the depth stop e in place. ► Insert the required drill into the MIS universal drill guide 16 up to the positive stop and verify the exposed length with a caliper (e.g. AA845R). The universal drill guide offers a range of up to 40 mm. ► Attach the Aesculap navigation adapter with 4 marker spheres (SZ091R) to the universal drill guide, see TA015762. ► Perform the calibration, see TA015762.

guide 16 (SZ143R). Check that the tip of the obturator 5 protrudes out of the guide, as shown on the left side of the image, see Fig. 2. ► Insert the assembly through the lateral stab incision into the surgical site. The flexibility of the soft tissue enables you to adjust its position in order to place it at the precise planned entry site for the pedicle screw. ► Remove the obturator 5 while holding the MIS universal drill guide 16, thereby maintaining its trajectory. Before removing the obturator 5 align the flattened section a of the obturator handle with the opening b of the depth stop c on the drill guide 16, as shown on the right side of the image, see Fig. 2. This ensures that the spring d on the shaft of the obturator 5 does not collide with the depth stop c of the drill guide 16.

3.2.2

Insert MIS universal drill guide

DANGER The patient can suffer from severe complications if the MIS universal drill guide slips out of its position or/and is positioned incorrectly! The position of the MIS universal drill guide affects all subsequent operative steps! ► When removing instruments (for example the obturator) during the procedure, make sure that the MIS universal drill guide remains firmly in place. ► When removing the obturator, make sure that the spring of the obturator does not collide with the depth stop of the drill guide. ► Always check the navigation to maintain the desired trajectory and positioning of the guide. WARNING Delay of surgery if the obturator is not inserted correctly! ► Check that the tip of the obturator is protruding out of the guide. ► Make a small stab incision through the skin, subcutaneous tissue and

dorsal fascia. The incision can be dilated with a haemostatic forceps.

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3.2.3

Open cortex: create pilot hole

WARNING Delay of surgery due to the introduction of a too small cortical punch in the right tube! ► Make sure to select the right cortical punch. Check the color coding and laser marking Cortical punches (SZ059R/SZ060R/SZ061R) are included in the Ennovate Cervical navigation set (see TA015762). The cortical punches are marked with a color coded ring according to the screw head color. ► Choose the appropriate cortical punch. ► Introduce the cortical punch into the MIS universal drill guide 16 (SZ143R). ► Position the cortical punch together with the MIS universal drill guide 16 on the desired entry point and advance the cortical punch into the bone until the stop is reached. Note The cortical punch has a positive stop in the drill guide 16 and protrudes 6 mm (independently of the depth stop). ► Remove the cortical punch.

en 3.2.4

Drill hole

WARNING Operation delay if hole position is lost! ► Do not remove the drill after drilling the hole. Only remove the drill handle or the motor system. The drill remains in the bone for the next step (dilation).

16a e 16a

The drill can be driven manually with a drill handle palm style (SZ003R) / drill handle teardrop style (SZ002R) or with a motor system and an AO small drill attachment (e.g. GB623R). a

d 2/3/4 16b/16c

16b/16c

16 2/3/4 b

► Remove the drill guide body 16a while the drill tube 16b/16c or

∅ 4.5 mm tube SZ058R remains in situ to protect the soft tissue: – Slide the golden lever arm d at the distal end of the drill guide body in a clockwise direction, as shown on the left side of the image, see Fig. 4 – Hold the golden lever d in this position and unlock the drill guide body 16a from the drill tube 16b/16c or ∅ 4.5 mm tube SZ058R by pulling the drill guide body upwards. Make sure that the drill does not get caught on the depth stop e. – Remove the drill guide body 16a by sliding it over the drill.

Fig. 3 ► Attach

the appropriate drill 2/3/4 (SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R) to the desired drill handle a (SZ002R or SZ003R) or to the motor system as described in the IFU for Ennovate Cervical Basic instruments (TA015763). ► Verify that the depth stop b of the MIS universal drill guide 16 (SZ143R) is still set at the desired depth. ► Insert the drill into the MIS universal drill guide 16 and advance the drill to the predefined depth under trajectory control with the Brainlab navigation system until the stop is reached. ► Leave the drill in place and only remove the drill handle a (SZ002R or SZ003R) or the motor system. 3.2.5

Fig. 4

3.2.6

Insert dilators

2/3/4

1

16b/16c

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a

Remove drill guide body

WARNING Operation delay if hole position is lost! ► Do not remove drill from the bone until the dilators have been placed. Only remove the drill guide body 16a. ► When removing the drill guide body 16a, make sure that the drill does not get caught on the depth stop and gets removed from the bone.

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a

Fig. 5 The fascia and muscles need to be dilated to allow for screw placement. the dilators over the drill 2/3/4 (SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R) and drill tube 16b/16c or ∅ 4.5 mm tube SZ058R starting with the small dilator 8 (SZ146R) and continuing with the large dilator 9 (SZ147R). Push and twist to dilate tissue. ► If preferred, a dilator handle 1 (SZ145R) is available: slide the pins of the handle into the slots a of the dilators. Turn the dilator handle 1 clockwise. The dilators should be docked on the bony anatomy to minimize the risk of soft tissue irritations. ► Slide

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Remove drill

3.2.9

CAUTION Operation delay (change to open technique) if the hole is lost (and cannot be relocated) when removing the drill! ► Hold the drill tube firmly in place while removing the drill.

Remove small dilator and drill tube

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► Attach a desired handle (SZ002R/SZ003R) and remove the drill 2/3/4

(SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R) by turning counter-clockwise. ► Once the drill is removed keep the drill tube firmly in place and immediately continue with the next surgical step inserting the K-wire.

16b/16c

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3.2.8 Insert K-Wire Two K-wires are available: ■ ∅ 1.0 mm K-wire long 7 (SZ158SU/SZ158R) for ∅ 3.6 mm MIS screws ■ ∅ 1.5 mm K-wire long 6 (SZ137SU/SZ137R) for ∅ 4.0 mm and 4.5 mm MIS screws DANGER Risk of injury if the K-wire is not properly fixed in the bone and thereby loses its position! ► Make sure to properly insert the K-wire in the pilot hole. ► Always check the position of the K-wire. CAUTION Operation delay (change to open technique) if the hole is lost (and cannot be relocated) before inserting the K-wire! ► Hold the drill tube firmly in place once the drill is removed until the K-wire is fully inserted.

6/7

16b/16c

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Fig. 7 ► Remove the small dilator 8 (SZ146R) and the drill tube 16b/16c or

∅ 4.5 mm tube SZ058R by hand. Constantly hold the K-wire 6/7 in place to make sure it does not move. Leave the large dilator 9 (SZ147R) in place as it serves as a working port during the subsequent surgical steps.

3.2.10 Cut thread with tap (optional) Ennovate Cervical MIS screws are equipped with a fully threaded, tapered tip reducing the need to tap. The use of a tap is recommended in case of a hard bone. This step is optional. ► Perform navigated tapping, see TA015762. 3.2.11 Prepare screw Cannulated long tab screws are available and dedicated to the MIS procedure. Refer to the surgical technique O03302 for more details. WARNING Operation delay if the long tabs of the MIS screw prematurely break or if implants get damaged due to loosening of the screw from the extended sleeve! ► Proceed with care when inserting the MIS long tabs into the extended tab sleeve. ► Visually inspect correct seating of the extended sleeve pin within one of the MIS sleeve holes. a

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b

c

11

Fig. 6 ► Select the appropriate K-wire 6/7. ► Insert the K-wire 6/7 through the drill tube 16b/16c or ∅ 4.5 mm

b

tube SZ058R into the pilot hole. Make sure that the threaded tip of the K-wire 6/7 is located at the distal end. ► Insert the K-wire 6/7 until the thread is fully inserted in the bone. The end of thread indicates the end position of the screw.

Fig. 8

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c

en ► Select the correct screw.

► Check the relative position of the two lines a, b on the MIS screwdriver

► Slide the extended tab sleeve 11 (SZ149R) over the MIS long tabs a in

in relation to the upper edge of the dilator 9: – Make sure that the dilator is fully seated on the bone. – If the first line a on the screwdriver lines up with the upper edge of the dilator, the threaded part of the screw is seated in the bone. – If the second line b on the screwdriver lines up with the upper edge of the dilator, the full screw length is seated in the bone. – To ensure maximum polyaxiality of the screw, do not tighten the screw completely down to the second line b. Leave a small gap below the head to allow rotation and angulation of the screw head. ► Once the screw is placed, remove the large dilator 9.

the direction of the arrow. Slightly press the long tabs a together to ease the sliding of the extended sleeve. A click is heard when the small pin c at the distal end of the extended tab sleeve clicks into one of the small holes b of the MIS long tabs. 3.2.12 Perform navigated screw placement

3.2.13 Prepare rod The MIS rods have a teardrop shaped geometry to engage with the rod inserter 13 (SZ151R). Rods are available in 10 mm increments. Do not cut the rods in order to maintain the blunt tip for screw insertion. ► Define the appropriate rod length with the navigation system or using rod templates. ► MIS rods have a predefined lordotic shape. If further bending is needed, bend the rod as described in TA015763.

L

Fig. 9 Note The screw length L is measured from the tip of the screw to the sphere of the screw shaft, see Fig. 9. To ensure maximum polyaxiality with the screw, do not tighten the screw completely down to the bone. Leave a small gap below the head to allow rotation and angulation of the screw head. Prepare the MIS screwdriver 12 (SZ150R), see TA015762. In TA015762 the steps are described with the screwdriver SZ063R. Proceed exactly in the same way with SZ150R. ► Perform the navigated screw insertion, see TA015762. ► To check if the final screw position has been reached: – Check the screw depth information of the navigation system. – Check the relative position of the MIS screwdriver 12 in relation to the dilator 9 as described in the next step.

12

a

b

9 Fig. 10

Note Be aware that an extremely bent rod might be difficult to insert through the MIS incision. 3.2.14 Insert rod WARNING Loss of the rod in situ may require the expansion of the skin incision! ► Do not decouple the rod inserter from the rod until the final position has been reached and the rod is completely fastened by at least one set screw. WARNING Inadequate fixation due to incorrect rod position! ► Check that the screw head is oriented orthogonally to the rod. ► Always position the MIS rods in such a way that the teardrop shaped tip and the conical tip are outside of the screw head. ► Select suitable rod lengths. When doing this, consider any possible corrective maneuver to be performed (e.g. distraction). ► Check the rod positioning before fastening with the set screw. WARNING Operation delay due to incomplete coupling of the rod on the rod inserter or incorrect alignment of the rod with the grooves of the extended sleeve. ► Insert the rod in the correct direction: check that the laser marked arrow on the rod inserter points to the rod tip. ► Verify a solid fixation of the rod in the rod inserter. ► Only tighten/loosen the golden rotary knob on the rod inserter by hand. Do not use any additional tools. ► Align the grooves of the extended sleeve so that the rod can be inserted.

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en 13

13 a

11

c b

b

3.2.16 Tighten set screw The final tightening of the set screw is performed as described in TA015763. the only difference is that the MIS counter torque handle 10 (SZ148R) is used instead of the counter torque handle SZ008R. ► Refer to TA015763 for all risks related to this step. ► Once the final tightening is achieved, detach the rod inserter 13 (SZ151R) from the rod by turning the golden knob a counter-clockwise, see Fig. 11. Remove the connection by pulling the rod inserter 13 out of the rod, e.g. by levering the rod inserter towards the construct. ► Once all set screws are fully tightened, visually double-check that the set screws are fully seated. The set screws are located plane with the top of the polyaxial screw tulips after final tightening with the ∅ 4.0 mm MIS rod. 3.2.17 Remove long tabs

Fig. 11 ► Unscrew the golden knob a of the rod inserter 13 (SZ151R) and slide

the teardrop shape b of the rod into the distal opening of the rod inserter so that the arrow c on the rod inserter points to the rod tip b. ► Turn the golden knob a clockwise to firmly tighten the rod in place. ► Turn the polyaxial screw so that the long slot of the extended tab sleeve 11 (SZ149R) is turned towards the rod. This can be done by hand or using the rod inserter 13. ► Guide the rod down through the long slots of the extended tab sleeve 11.

WARNING Risk of correction loss / insufficient stabilization of the spinal column due to under-tightening of the set screw! ► Break off the long tabs only once the set screws have been fully tightened.

11

14

3.2.15 Insert set screw 11 a

a

a

a

13

Fig. 13 ► Remove the extended tab sleeve 11 (SZ149R): slightly press or pull the

10

b

Fig. 12 ► Use the MIS counter torque 10 (SZ148R) to persuade the rod in the

polyaxial screw head. ► Load the set screw on one of the set screw starters a (SZ068R or

SZ069R), see TA015763. ► Insert the set screw through the long tabs of the MIS screw into the

polyaxial body. Provisionally tighten the rod with the set screw, see TA015763.

10

flute lateral to the MIS screw long tabs a to disengage the connection and slide off the extended tab sleeve. ► Remove the long tabs a with the MIS tab breaker 14 (SZ153R).

en 3.3

MIS extended workflow

3.3.2

The extended workflow offers an enhanced control of the screw entry point. The surgical workflow is equal to the streamlined workflow until the pilot hole has been drilled. In the extended workflow the cannulated drill stays in the pilot hole while the K-wire is inserted. A dedicated drill removal tool 15 (SZ157R) allows to remove the drill while the K-wire safely stays in place. The only difference to the streamlined workflow concerns the removal of the drill (see Chapter 3.2.7) and the insertion of the K-wire (see Chapter 3.2.8). All other steps are performed in the exact same manner and are therefore not described in this section. ► Perform all steps of the streamlined workflow until you finish the insertion of the dilators (see Chapter 3.2.6). Two K-wires are available: ■ ∅ 1.0 mm K-wire long 7 (SZ158SU/SZ158R) for ∅ 3.6 mm MIS screws ■ ∅ 1.5 mm K-wire long 6 (SZ137SU/SZ137R) for ∅ 4.0 mm and 4.5 mm MIS screws

Insert drill removal tool

6/7 15 a

2/3/4

b

9

b 9

Fig. 15 ► Slide

3.3.1 Insert K-wire into the drill removal tool ► Select the appropriate K-wire 6/7. 6/7 b 6/7 15

b a

the assembly through the cannulated drill 2/3/4 (SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R). ► Swing the drill removal tool 15 (SZ157R) slightly lateral so that the slider a passes the drill stop. ► Slide the assembly down until its distal part b sits on the large dilator 9 (SZ147R). This allows the slider to engage with the drill stop in the next steps. 3.3.3

Align K-wire to the drill tip

a

6/7 c

Fig. 14

b

6/7

2/3/4

2/3/4

► Insert the K-wire into the drill removal tool 15 (SZ157R):

– Turn the golden K-wire lock a counter-clockwise to allow K-wire insertion. – Hold the K-wire with the threaded tip pointing down. After the insertion the threaded tip should be located at the distal end of the drill removal tool to be able to engage with the bone. ► Slide the K-wire into the drill removal tool 15 until the central black marking b is partly covered by the K-wire lock a. ► Re-tighten the K-wire by turning the K-wire lock a clockwise. ► Press the golden ratchet lever c and move the slider to the distal starting position.

Fig. 16 ► Turn the golden K-wire lock a counter-clockwise to release the K-wire. ► Advance the K-wire manually until the central black marking b on the

K-wire is fully inserted into the cannulated drill 2/3/4 (SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R). This aligns the K-wire tip with the drill tip. ► Re-tighten the K-wire by turning the K-wire lock a clockwise. Note To avoid a protruding K-wire do not advance it beyond the laser marking.

11

en 3.3.4

Remove drill

WARNING Operation delay due to difficulty to remove the drill with drill removal tool (bone material stuck in the cannulated drill)! ► Change to the streamlined workflow if the drill cannot be removed with the drill removal tool. a

6/7

2/3/4

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.

15

2/3/4

c

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.

Fig. 17 ► Turn the golden hand wheel c clockwise.

This extracts the drill 2/3/4 (SZ013SU/SZ013R, SZ014SU/SZ014R, SZ015SU/SZ015R) while holding the K-wire 6/7 (SZ137SU/SZ137R or SZ158SU/SZ158R) in place, as can be seen on the left side of the image, see Fig. 17. ► Once the drill is fully removed from the bone, release the K-wire lock a by turning it counter-clockwise, as can be seen on the right side of the image, see Fig. 17. ► Remove the drill removal tool 15 (SZ157R) and the drill 2/3/4. Ensure that the K-wire is not pulled out of the pilot hole: hold the K-wire in place. Note Due to bone material in the tip of the cannulated drill it may happen that the black marking on the K-wire cannot be fully inserted into the cannulated drill and that the drill can not be removed with the drill removal tool. Please change to the streamlined workflow, see see Chapter 3.2. ► Perform all subsequent steps starting from the removal of the small

dilator (see Chapter 3.2.9) to the end.

12

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".

en 4.3

Single-use products

For the list of single use products, see Chapter 2.2.3. ► 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 and K-wires with new gloves only. ► Keep the drill and K-wire storage trays covered or closed. ► Process drill and K-wire storage devices/trays separately from instrument trays. ► Clean drills and K-wires must not be cleaned together with contaminated drills and K-wires. ► Reprocess the drills and K-wires 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 and K-wires.

4.7

Disassembly

4.7.1

MIS universal drill guide (SZ143R)

a

c

Fig. 18 ► Remove the tubes 16b/16c. ► Pull the depth stop a all the way up so that it is loose and the inner part

of the drill guide can be rinsed. ► Unscrew and remove the inner shaft b from the handle c. 4.7.2

4.4

b

MIS rod inserter (SZ151R)

Reusable products a

For the list of instruments that can be reused and must be sterilized prior to each use, see Chapter 2.2.3. 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.

► Unscrew and remove the golden locking knob a.

4.5

4.7.3

Preparations at the place of use

13 Fig. 19

► If applicable, rinse non-visible surfaces preferably with deionized

b

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

Drill removal tool (SZ157R)

a

Fig. 20 ► Turn the K-wire locking knob a counter-clockwise until it is loose..

various components. ► Disassemble the product prior to cleaning, see Chapter 4.7. ► Open up product with hinges.

13

en 4.8

Cleaning/Disinfection

4.8.1

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

4.8.2

► 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 ► 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.

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:

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

Chapter Manual cleaning/disinfection and subsection:

Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that is suitable for cleaning (avoiding

Chapter Mechanical cleaning/disinfection and subsection:

■ SZ013R to SZ015R ■ SZ137R ■ SZ144R to SZ147R ■ SZ158R

■ Chapter Mechanical alkaline cleaning ■ Place products in the tray with their hinges open. and thermal disinfecting ■ SZ145R to SZ147R: Rinse the product under running water. Move

■ SZ013R to SZ015R ■ SZ137R ■ SZ144R to SZ149R ■ SZ151R ■ SZ153R ■ SZ158R Manual cleaning with ultrasound and immersion disinfection

■ SZ143R ■ SZ150R ■ SZ157R

rinsing blind spots).

■ Chapter Manual cleaning with immersion disinfection

■ Chapter Manual cleaning with ultrasound and immersion disinfection

the moving parts while doing so.

■ SZ145R to SZ147R: Connect components with lumens and channels directly to the rinsing port of the injector carriage.

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

■ SZ143R ■ SZ148R to SZ149R ■ SZ151R ■ SZ153R ■ SZ157R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ SZ150R

Chapter Mechanical cleaning/disinfec■ Suitable cleaning brush tion with manual pre-cleaning and sub■ 20 ml disposable syringe section: ■ Place the product in a tray that is suitable for cleaning (avoiding ■ Chapter Manual pre-cleaning with a rinsing blind spots).

■ Place products in the tray with their hinges open. ■ Chapter Mechanical alkaline cleaning and thermal disinfecting ■ SZ143R, SZ148R and SZ151R: Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with their hinges open. ■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

14

brush

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

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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 Chapter 4.8.2. 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.

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 Chapter 4.8.2.

► Mobilize non-rigid components, such as set screws, links, etc. during

cleaning. ► Thoroughly rinse through these components with the cleaning disin-

fectant 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.

15

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 Chapter 4.8.2. 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 Chapter 4.8.2.

16

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.

17

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 Chapter 4.8.2. 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 disin-

fectant 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.

18

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 Chapter 4.8.2. 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.

19