Ennovate instruments for deformity

en

Aesculap® Ennovate® Instruments for deformity Legend

Contents

1 Ennovate quick tube, long SZ334R 2 Ennovate quick tube, short SZ359R 3 Ennovate coronal rod bender, left SZ344R 4 Ennovate coronal rod bender, right SZ345R 5 Ennovate deformity counter torque SZ335R 6 Ennovate deformity set screw driver SZ355R 7 Ennovate deformity set screw starter SZ354R 8 Ennovate DT insert pusher SZ339R 9 Ennovate DT combo pusher SZ341R 10 Ennovate DT rod pusher SZ340R 11 Ennovate derotation tube SZ336R 12 Ennovate hook holder tube SZ357R 13 Ennovate hook pusher SZ358R 14 Ennovate lamina elevator SZ352R 15 Ennovate pedicle preparator SZ351R 16 Ennovate rod gripper SZ332R 17 Ennovate rod rotation wrench SZ333R 18 Ennovate sagittal bender, left SZ342R 19 Ennovate sagittal bender, right SZ343R 20 Ennovate segmental coupler SZ337R 21 Ennovate segmental coupler pin S SZ346R 22 Ennovate segmental coupler pin M SZ347R 23 Ennovate segmental coupler pin L SZ348R 24 Ennovate segmental coupler pin XL SZ349R 25 Ennovate segmental coupler pin XXL SZ350R 26 Ennovate table top rod cutter SZ330R 27 Ennovate transverse coupler, S SZ328R 28 Ennovate transverse coupler, M SZ329R 29 Ennovate transverse coupler, L SZ338R 30 Ennovate transverse process elevator SZ353R

1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.2 2.2.1 2.2.2 2.2.3 3. 3.1 3.1.1 3.1.2 3.2 3.3 3.4 3.5 3.6 3.7 3.7.1 3.7.2 3.8 3.8.1

The depictions in this document are schematic representations only and may deviate from the actual product.

2

3.8.2 3.9 3.10 3.10.1 3.10.2 3.10.3 3.10.4 3.11 3.11.1 3.11.2 3.11.3 3.11.4 3.12 3.12.1 3.12.2 3.13 3.13.1 3.13.2

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Absolute contraindications... Relative contraindications... Safety information... Clinical user... Product... Sterility... Application... Place tubes on the levels requiring derotation... Attach derotation tube 11 (option 1)... Attach quick tube 1 or 2 (option 2)... Attach transverse couplers to tubes... Activate PolyLock® on all levels requiring derotation... Perform derotation maneuvering... Perform en-block derotation maneuvering... Cut rod... Contour rod ex-situ... Bend rod with french rod benders SZ270R... Bend rod with sagittal rod benders... Place and push rod... Push rod into screw head while utilizing derotation tube (option 1)... Push rod into screw head while using quick tubes (option 2). Perform parallel compression and distraction... Insert set screw... Insert set screw using long quick tube... Insert set screw using short quick tube... Insert set screw using derotation tube and DT combo pusher Insert set screw using derotation tube and DT rod pusher . . . Insert and tighten set screw with deformity set screw driver. Tighten set screw using long quick tube... Tighten set screw using short quick tube... Tighten set screw using derotation tube and combo pusher . Tighten set screw using derotation tube and rod pusher... Contour rod in-situ... Contour rod in sagittal plane... Contour rod in coronal plane... Place hook... Place pedicle hook... Place hook using lamina and transverse process...

3 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 5 5 6 6 7 8 9 9 9 10 10 11 11 12 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15

en 4. 4.1 4.2 4.3 4.4 4.5 4.5.1 4.5.2 4.6 4.6.1 4.6.2 4.7 4.7.1 4.7.2 4.8 4.8.1 4.9 4.9.1 4.9.2 4.9.3 4.10 4.10.1 4.10.2 4.11 4.11.1 4.11.2 4.11.3 4.12 4.13 4.14 5. 6. 7.

Validated reprocessing procedure... 15 General safety instructions... 15 General information... 16 Preparations at the place of use... 16 Preparing for cleaning... 16 Disassembly... 16 Table top rod cutter... 16 Coronal Benders... 16 Cleaning/Disinfection... 17 Product-specific safety information on the reprocessing method... 17 Validated cleaning and disinfection procedure... 17 Manual cleaning/disinfection... 19 Manual cleaning with immersion disinfection... 19 Manual cleaning with ultrasound and immersion disinfection 20 Mechanical cleaning/disinfection... 21 Mechanical alkaline cleaning and thermal disinfecting... 21 Mechanical cleaning/disinfection with manual pre-cleaning . 22 Manual pre-cleaning with a brush... 22 Manual pre-cleaning with ultrasound and brush... 22 Mechanical alkaline cleaning and thermal disinfecting... 23 Inspection... 23 Visual inspection... 23 Functional test... 23 Assembly... 24 Table top rod cutter... 24 Coronal Benders... 24 Quick tubes... 24 Packaging... 25 Steam sterilization... 25 Storage... 25 Technical service... 25 Disposal... 25 Symbols on product and packaging... 25

1.

About this document

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

1.1

Scope

These instructions for use apply to Ennovate instruments for deformity. 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 indicate 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 product damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1 Intended use The Ennovate instruments are used for the implantation of Ennovate spinal system implants. 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. For indications, see Intended use. 2.1.3 Absolute contraindications Absolute contraindications are described in the instructions for use of the Ennovate implants TA014887. 2.1.4 Relative contraindications Relative contraindications are described in the instructions for use of the Ennovate implants TA014887.

3

en 2.2

Safety information

3.

2.2.1

Clinical user

When using K-wires, observe the following two warning notices and refer to the instructions for use for Ennovate MIS instruments TA014987 and the operating manual for the MIS module O00702.

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product. 2.2.2

Product

Product-specific safety information ► See instructions for use for the Ennovate handles TA015007, Ennovate

open instruments TA014986, Ennovate implants TA014887, operating manual for the complex spine module, O02302, and operating manual for the open module O48102. ► Use the product only in applications according to its intended use, see Intended use. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. Ennovate surgical instruments are only intended to be used with Ennovate implants ► Only use Ennovate instruments with Ennovate implants.

Application

DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in case of incorrect application! ► Alignment and insertion of the instruments, K-wires and pedicle screws may only be carried out under radiographic control or aided by a navigation system. ► Carefully guide instruments over the K-wires. When doing this, make sure that the K-wire remains in its position. ► Do not bend K-wires. Immediately replace bent K-wire. ► Inspect the cannulas of the instruments for passage before every application. DANGER Injury of spinal cord, nerve roots and blood vessels due to bent K-wire or K-wire not holding in the bone! ► Do not reuse K-wires. ► Use K-wires only with intended K-wire pliers. ► Carefully drive in K-wires. ► Do not bend K-wires. Immediately replace bent K-wires. ► Insert K-wire in the correct direction, with the roughened end forward. ► Only use K-wires SZ369S, SZ369SU, SZ370 or SZ370SU of the Ennovate system. WARNING Risk of injury and/or malfunction! ► Always carry out a functional test prior to each use of the product. ► Only use Ennovate surgical instruments with Ennovate implants. CAUTION 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. Note All handles and handle surfaces are black. All actuating elements that are actuated during the operation are gold colored.

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

2.2.3 Sterility The product will be delivered non-sterile. ► Clean the new product after removing its transport packaging and prior to its initial sterilization, see Validated cleaning and disinfection procedure.

PolyLock® Using PolyLock®, the polyaxiality of a polyaxial pedicle screw can be temporarily blocked by means of specialized instruments of the Ennovate system, without already using a rod or a set screw when doing so. The polyaxial screw thus temporarily becomes a monoaxial screw. PolyLock® can be activated and deactivated three times per pedicle screw during instrumentation. For information on how to activate and deactivate PolyLock®, see Activate PolyLock® on all levels requiring derotation. Note PolyLock® does not need to be deactivated before the final interlocking of the polyaxial screw with the rod and set screw.

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en 3.1

Place tubes on the levels requiring derotation

► For the instructions on Ennovate pedicle screw implantation refer to

the instructions for use TA014986 and the operating manual O02302. WARNING Risk of injury and/or malfunction! ► Always carry out a function test prior to each use of the product. ► Visually inspect the connection geometry prior to use. ► Ensure that the wound area is prepared so soft tissue interference with the instruments is avoided. 3.1.1

Attach derotation tube 11 (option 1)

b 11

► Visually inspect the connection. In case of faulty assembly, the next

step cannot be performed. ► Repeat the three steps as required. Note If contra-rotational corrective forces are desired, additional tubes 1 or 11 may be placed on the next distal and/or proximal levels as needed.

3.2

DANGER Risk of Severe Injury! ► In order to avoid unwanted motion of transverse couplers under derotation loading, make sure to tighten the transverse couplers.

b

a

Attach transverse couplers to tubes

27/28/29 a

11

Fig. 1 ► Place the derotation tube 11 on the head of the pedicle screw a and

latch the lateral catches b completely in the interface on the head of the pedicle screw a until an acoustic signal is audible. ► Visually inspect the connection. In case of faulty assembly, the next step cannot be performed. ► Repeat the two steps as required. 3.1.2

Attach quick tube 1 or 2 (option 2)

a

b

1/2 d c

Fig. 2 ► Make sure that the quick tubes 1 or 2 are in the starting position:

– Rotate the threaded spindle a counter clockwise all the way to the top. –or– – Press both push-buttons b and pull threaded spindle a completely out up to the top . ► Place the tube on the head of the pedicle screw c and latch the lateral catches d completely in the interface on the head of the pedicle screw c until an acoustic signal is audible.

Fig. 3 ► Determine the appropriate length of the transverse couplers 27/28/29

based on the patient’s anatomy. ► Prior to attachment, ensure that the transverse couplers 27/28/29 are

in the unlocked position by turning the golden knob a counter-clockwise. ► Align the snap-in couplings upwards and slide them over the tubes 1 or 11 until an acoustic signal is audible. The sound is an indicator that proper attachment has been achieved. ► Visually inspect the connection. Note In order to apply less weight from the instruments and allow the surgeon a better field of view, the short quick tube 2 has no geometry for the connection of the transverse couplers 27/28/29. If transverse couplers are required at these levels switch to the tall quick tube 1 or derotation tube 11. WARNING Risk of incorrect attachment! Transverse couplers cannot be attached to the short quick tube! ► Attach transverse couplers to connecting instruments such that the label “UP” points away from the patient and the label “DOWN” points towards the patient. ► Ensure proper alignment prior to connection. ► Triangulate the tubes by using transverse couplers starting from the

neutral vertebra and working along the thoracic and lumbar levels that require derotation. ► Secure the triangulation by turning the golden knob a clockwise using the rod pusher handle SZ390R.

5

en 3.3

Activate PolyLock® on all levels requiring derotation

a a

Note Quick tubes 1 and 2 do not have a PolyLock® function. If PolyLock® is required at a certain location, use the derotation tube 11. WARNING Injury to the patient from initiation of high torques on the spinal column! ► Always use a counter torque handle for tightening the set screw and when activating PolyLock®. ► Always completely and correctly insert the counter torque handle in the respective receptacle geometry. Check for the correct positioning. ► Hold the counter torque handle in position and do not twist or lever against the tube or the inserted rod.

5

b

Fig. 5 ► Push the 10 N∙m torque handle a (SZ228R) on to hex connection of the

WARNING Damage to instruments! Applying more than 10 N∙m of torque to the quick tubes can damage the threading. ► Only apply enough torque to persuade the rod into the head of the screw or hook. ► Do not tighten the quick tubes after full persuasion has occurred.

Ennovate polyblocker b (SZ393R) up to the stop, forming the PolyLock® assembly, see Fig. 5. ► Engage the deformity counter torque 5 or segmental coupler 20 to the coupling geometry on the derotation tube 11 and place the PolyLock® assembly into the upper portion of the DT insert pusher 8.

a

8 b 20

27/28/29 5 11

Fig. 6 ► Visually inspect the connection.

Fig. 4 ► Slide and thread the DT insert pusher 8 into the derotation tube 11

using the rod pusher handle SZ390R.

► For information on attaching segmental couplers to the construct, see

Perform derotation maneuvering. ► Turn the PolyLock® assembly while firmly holding the deformity coun-

ter torque 5 or segmental coupler 20 until an acoustic signal sounds from the 10 N∙m torque handle a (SZ228R). The sound is an indicator that PolyLock® has been activated.

3.4

Perform derotation maneuvering

► Derotate the distal vertebra to a neutral position while holding the cor-

responding proximal neutral vertebra steady as a foundation for force application. ► If needed, attach derotation tubes 11 or quick tubes 1 onto the remaining screws. Note These instruments may be connected by transverse couplers 27, 28, or 29 in order to achieve instrument triangulation of all levels requiring derotation, see Place tubes on the levels requiring derotation, see Attach transverse couplers to tubes.

6

en ► If needed attach the segmental couplers 20 to the connection geome-

try of the derotation tubes 11 or the quick tubes 1. ► Align the snap-in couplings upwards and slide them over the tube 1 or 11 until an acoustic signal sounds. The sound is an indicator that proper attachment has been achieved. ► Visually inspect the connection. To ensure the most effective transmission of force to the screw head the following possible combinations of screws and tubes are recommended: ► When utilizing PolyLock®, use the derotation tube 11 to derotate all screw types. ► When not utilizing PolyLock®, use the long quick tube 1 to derotate monoaxial and uniplanar screws. Attempting to derotate with a quick tube on a polyaxial or favored angle screw will cause the screw head to rotate without derotation occurring. Note In order to apply less weight from the instruments and allow the surgeon a better field of view the short quick tube 1 may be used on levels which do not require derotation force application. WARNING Risk of Incorrect attachment! Segmental couplers cannot be attached to the short quick tube! ► Attach segmental couplers to connecting instruments such that the label “UP” points away from the patient and the label “DOWN” points towards the patient. ► Ensure proper alignment prior to connection.

► If needed, retain the correction by sliding segmental coupler pins 21–

25 through the slots of the segmental couplers 20. CAUTION Instrument can fall in-situ or on the floor! Segmental coupler pins are not fixated to segmental couplers! ► Make sure that the segmental coupler pins are engaged in such a way that motion of the construct will not result in disengagement. Note It is recommended to define appropriate blocks, according to the present pathology, and determine the appropriate length of the segmental coupler pins 21–25 based on the number of levels to be aligned.

3.5

Perform en-block derotation maneuvering

In case of an en-bloc derotation, the levels requiring derotation may be divided into smaller blocks in order to achieve the most effective correction possible. In the event of a double major curve, two derotation blocks may lead to the desired correction. Whereas, for single thoracic and triple major curves, three derotation blocks may be considered. ► If needed, attach further segmental couplers 20 on the remainder of the levels requiring derotation that have previously been instrumented with derotation tubes 11 or quick tubes 1, as well as transverse couplers 27, 28, or 29. For the assembly instructions for segmental couplers 20, see Perform derotation maneuvering. ► Prior to the correction, make sure that all levels within the blocks are retained by the segmental coupler pins 21–25. ► Correct the spine by slowly derotating the blocks in opposing directions until the desired axial plane correction is achieved. ► The correction of the rib prominence can be additionally assisted by simultaneously pressing down on the convex ribs and convex screws. 27/28/29

11

20

20

21–25

Fig. 7 ► Derotate the distal vertebra to a neutral position while holding the cor-

responding proximal neutral vertebra steady as a foundation for force application. Attempting to derotate with quick tubes on polyaxial or favored angle screws may cause the screw heads to rotate without derotation occurring. ► If additional segmental correction is required, hold the adjacent level that requires derotation steady and derotate the level further.

21–25

Fig. 8 ► Once the desired spinal alignment has been achieved, the derotation

can be retained by sliding a longer segmental coupler Pin 21–25 through the aligned holes of the segmental couplers 20 of all involved blocks.

DANGER Risk of Severe Injury! Damage to spinal cord, nerve roots, and blood vessels due to rotation! ► Do not over-rotate spine!

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en 3.6

Cut rod

If necessary, the table top rod cutter 26 may be used to assist rod cutting to the required length. ► To determine the length required of the rod: place the flexible rod template SZ267SU in the screw heads or hooks in the same position the rod will later be placed. Bend the flexible rod template according to the corrected spine position. ► Make sure that one end of the pedicle screw construct is near the “1” marking on the flexible rod template. ► Determine the required rod length by reading the numerical marking that comes after the last screw on the other end of the construct. WARNING Injury to the user! Damage to instruments! ► Open gearing and high torque can pinch gloves, fingers, or loose clothing. ► Brace the rod cutter with one hand while turning the handle with the other. ► Only use the Ennovate quick connect T-handle SZ224R. Do not use a torque handle.

► Attach the Ennovate quick connect T-handle SZ224R to the table top

rod cutter 26. 26

a

Fig. 10 ► Turn the handle SZ224R until the arrow a on the large worm gear is

pointing up. ► Align the location on the rod with the marking on the side of the table

top rod cutter 26. ► Adjust gripping so an additional 25 mm is added to the rod.

WARNING Damage to the implant or instrument! Risk of instrument malfunction! ► Only use the rod cutter to cut Aesculap Ennovate 5.5 mm rods. WARNING Risk of instrument malfunction! Improper assembly will cause damage to implant and instrument! ► Make sure that all the assemble steps have been executed prior to use. ► Disassemble jammed instruments. ► Inspect cutting bearings for damage prior to each use.

Note In order to quickly add 25 mm to the rod marking, realign the edge of the finger grip with the face of the table top rod cutter while the desired location of the rod is aligned with the laser marking on the side of the instrument. Then insert the rod into the rod cutter until the same finger grip contacts the front of the instrument’s gold bushing screws. 26

► Straighten the flexible rod template, keeping note of the marking that

denotes the end of the construct. ► Determine the most appropriate length of the rod using the ruler

AA804R or the now straightened flexible rod template SZ267SU. CAUTION Operational delay! ► Make sure that possible compression and distraction maneuvers are evaluated to determine the effect on the rod length requirement prior to cutting the rod.

Fig. 11 WARNING Risk of instrument malfunction! ► Do not insert curved rods into the rod cutter. ► Insert the rod into the center cutter bushing up to the new grip (mea-

Fig. 9

sured length plus 25 mm). ► Turn the T-handle SZ224R clockwise until the inner housing makes a full revolution and an audible signal sounds. The sound is an indicator that the rod has been cut. ► Remove the newly cut rods from the center bushing screws. Note If the rod can not to be cut properly, new bushing screws can be added to replace worn ones. It is recommended to replace the bushing screws after each surgical operation.

8

en Note If the rod can not to be removed from the table top rod cutter 26, the bushings may have to be unthreaded and the rod removed from the bushing in the opposite direction, see Disassembly, see Assembly. Note Replacement bushing screws for the table top rod cutter 26 may be ordered from your Aesculap representative under the part number SZ330206.

3.7

Note The rod b has an orientation line that facilitates the alignment of the rod during the bending process. Note In addition, the rod grippers 16 or rod holding forceps SZ272R could be used to prevent undesired rod rotation during the bending process. 16

Contour rod ex-situ

► For ex-situ rod contouring, place the flexible rod template SZ267SU in

the head of the screws or hooks and bend it according to the corrected spine. ► Carefully remove the rod template so it is not incorrectly repositioned, and use it for reference when bending the rod ex-situ.

e

Fig. 12 WARNING Danger of injury from damage (breakage) of the rod if bent incorrectly! Rod cannot be inserted into the tube! Rod cannot be fastened! ► Avoid severe rod bending in the region of the pedicle screw or hooks. ► Only bend rod with provided rod bending instruments. ► Do not bend rod multiple times at the same location. ► Do not bend rod back. 3.7.1 Bend rod with french rod benders SZ270R If necessary, the rod can be bent with the french rod benders SZ270R. Three different bending radii can be set on the rod bending pliers.

► To prevent undesired rod rotation during the bending process, use the

additional rod grippers 16 or rod holding forceps SZ272R. 3.7.2 Bend rod with sagittal rod benders Rods may be contoured using the sagittal rod benders left 18 (SZ342R) and right 19 (SZ343R), which also allow for small radius bending.

18

19

Fig. 14 b

► To contour the rod, slide the rod into the desired hole of each sagittal

rod bender.

c

c

a

Note The sagittal rod benders have two sets of holes, one set straight through the shafts and one set at an angle through the shafts to allow for multiple exsitu bending curves.

e d

► Grip the most distal portions of the sagittal rod benders for enhanced

mechanical advantage during contouring. ► By levering the sagittal rod benders the rod is bent according to the desired contour. Fig. 13 ► Adjust desired bending radius on the french rod benders e: pull rotary

knob a and set the desired radius by turning ► Place rod b between rotary knob a and the two rollers c. ► Bend rod b to the desired radius by actuating the handle d of the

french rod benders SZ270R.

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en 3.8

► When using the DT insert pusher 8 during other portions described in

Place and push rod

WARNING Revision required due to faulty fastening of the rod! ► Select suitable rod lengths in consideration of any possible corrective maneuver to be performed (e.g. distraction). ► Verify rod positioning under radiographic control before fastening with the set screw. ► Align the contoured rod along the patient’s physiological sagittal pro-

file and slide it through the longitudinal slots of all derotation tubes 11 and quick tubes 1 or 2. 3.8.1

Push rod into screw head while utilizing derotation tube (option 1)

DANGER Risk of severe injury! Pedicle screw can tear out of spinal column if too much force is applied when pushing the rod! Revision required in case of rod break! Damage to pedicle screw due to forces being too high! ► Make sure that the forces applied when turning the cap of the DT rod pusher, or DT combo pusher to the line marking are not too high. When the “0” marking band is reached, the forces are no longer transmitted to the rod, but rather transposed into the interlock of the polyaxiality (PolyLock®). CAUTION Operational delay! Instrument slips from screw head! Set screw cannot be inserted into screw head! Rod cannot be fixated! ► Insert the derotation tube 11 correctly into the interface on the screw head. Check for correct positioning. ► Push rod completely up to the stop in the pedicle screw by turning the cap of the DT rod pusher 10 or DT combo pusher 9 until the “0” marking band is reached. Observe and verify the correct rod position in the head of the pedicle screw. ► For connection of derotation tubes to levels not yet instrumented see

Place tubes on the levels requiring derotation.

6

10

other chapters, the set screw driver 6 must be assembled into the DT rod pusher 10 and engaged with a set screw (SY001T/SY001TS) prior to insertion into the DT insert pusher 8. While the set screw driver is inside the DT rod pusher, completely attach a set screw to the set screw driver. To do so, insert the working end b into the socket of the set screw a and push with light pressure until the line marking c terminates flush with the surface. ► Insert the set screw/set screw driver/DT rod pusher assembly into the DT insert pusher 8. CAUTION Operational delay! Rod cannot be fixated! Set screw cannot be passed through DT rod pusher! ► Set screw driver and set screw must be preloaded into DT rod pusher prior to insertion into DT insert pusher. ► Set screw driver and set screw might become disengaged with each other if set screw driver is pulled up from the DT rod pusher prior to threading set screw into screw or hook head.

9

Fig. 16 ► If the DT insert pusher 8 was not used, slide the DT combo pusher 9

directly into the derotation tube 11. ► Once the cap of the DT rod pusher 10 or the DT combo pusher 9 has

contacted the top of the derotation tube 11, thread the gold cap clockwise until the rod is completely seated into the head of the pedicle screw. Insert the rod pusher handle SZ390R into the golden cap of the DT rod pusher or DT combo pusher to facilitate this step.

c b a

6 c a

Fig. 15

Fig. 17

10

en ► The marked scale on top of the DT rod pusher 10 and DT combo

3.9

pusher 9 indicates the amount of persuasion left until the rod is fully seated into the screw head. ► The rod is completely in the screw head when the “0” marked scale band on the cap terminates flush with the top of the derotation tube.

For parallel compression or distraction, ensure that PolyLock® is activated for force transmission. If using the DT rod pusher 10, it can be loosened slightly to allow for easier parallel compression or distraction.

Note The derotation tube 11 can still be moved along the rod and tilted slightly in order to carry out any necessary distraction or compression maneuvers. 3.8.2

Push rod into screw head while using quick tubes (option 2)

DANGER Risk of severe injury! Pedicle screw can tear out of spinal column if too much force is applied when pushing the rod! Revision required in case of rod break! Damage to pedicle screw due to forces being too high! ► Make sure that the forces applied when turning the cap of the quick tubes are not too high. ► Only apply enough torque to persuade the rod into the head of the screw or hook. ► Do not tighten the Quick Tubes after full persuasion has occurred. CAUTION Operational delay! Instrument slips from screw head! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Connect the quick tube correctly into the interface on the screw head. Check for correct positioning. ► Seat the rod completely up to the stop in the pedicle screw by turning the gold cap of the quick tube clockwise until rod is fully seated. Observe and verify correct rod position into the head of the pedicle screw.

Perform parallel compression and distraction

WARNING Insufficient treatment or stabilization of the spinal column region to be treated! Damage to the implant and/or instruments! ► Before every corrective maneuver: Verify the correct seating of the attachments on the parallel distractor handle or on the parallel compressor handle and correct contact of the instruments on the pedicle screws. WARNING Injury to patient from initiation of high forces on the spinal column! ► Avoid excessive distraction or compression. Note The derotation tube 11 can still be moved along the rod and tilted slightly in order to carry out any necessary distraction or compression maneuvers.

1/11 a

7

Fig. 19 a

► Place the distraction forceps SZ233R or FW281R, between the derota-

1/2 b

Fig. 18

tion tubes 11 or quick tubes 1 and 2 and squeeze the handles until the desired correction is achieved. As a result, the distance between the elements increases evenly. ► For parallel compression, place the compression forceps SZ234R or FW282R, around the derotation tubes 11 or quick tubes 1 and 2 and squeeze the handles until the desired correction is achieved. As a result, the distance between the elements decreases evenly. ► Once the desired correction is achieved, retighten the DT rod pusher 10 to retain the position of the spinal segment using a handle if it was loosened. Note When using the DT rod pusher 10, the deformity set screw starter 7 should be used to initially implant the set screws.

► For connection of the quick tubes to levels not yet instrumented, see

Place tubes on the levels requiring derotation. ► Press threaded spindle a down or screw in by rotating clockwise until

the threaded spindle a sits on the rod. ► Turn threaded spindle a clockwise until the rod is completely counter-

sunk in the head of the pedicle screw b.

CAUTION Damage to implant and instrument! ► The deformity set screw starter 7 should be used to prevent cross threading when using the DT combo pusher 9 to persuade the rod or PolyLock®.

11

en 3.10 Insert set screw If the rod was previously pushed with the DT combo pusher 9 or quick tubes 1 or 2 the set screw should be temporarily inserted before final tightening to ensure proper thread engagement. CAUTION Intraoperative revision required! Operation delay! Damage to the implant and instruments! ► Receive set screw correctly and completely up to the line marking with the insertion instrument for the set screw. ► Always place set screw driver and starter axially to the head of the pedicle screw and do not tilt. 6/7 c b

3.10.3 Insert set screw using derotation tube and DT combo pusher ► Completely take up the set screw a (SY001T/SY001TS) with the deformity set screw starter 7. To do so, insert the working end b into the socket of the set screw a and push with light pressure until the line marking c terminates flush with the surface, see Fig. 20. ► Verify solid seating of the set screw a on the deformity set screw starter. ► Place the set screw a with the set screw starter 7 aligned axially to the cannula of the derotation tube and slide the set screw starter through the cannula. ► Screw the set screw a into the head of the pedicle screw d from the top until the set screw a has contact with the rod e. ► Rotate the set screw starter 7 clockwise while the set screw engages with the pedicle screw thread. ► Stop the rotation when the set screw a tightens against the rod. 3.10.4 Insert set screw using derotation tube and DT rod pusher

e

a d

a

Note The set screw should already be attached to the deformity set screw driver 6 inside the cannula of the DT rod pusher 10, see Push rod into screw head while utilizing derotation tube (option 1)

6/7 c a e

Fig. 20 3.10.1 Insert set screw using long quick tube ► Completely take up set screw a (SY001T/SY001TS) with the deformity set screw starter 7. To do so, insert the working end b into the socket of the set screw a and push with light pressure until the line marking c closes flush with the surface, see Fig. 20. ► Verify solid seating of the set screw a on the deformity set screw starter 7. ► Place the set screw a with the set screw starter 7 aligned axially to the cannula of the tube and slide the set screw starter 7 through the cannula. ► Screw the set screw a into the head of the pedicle screw d from the top until the set screw a has contact with the rod e. ► Rotate the set screw starter 7 clockwise while the set screw engages with the pedicle screw thread. ► Stop the rotation when the set screw a tightens against the rod. 3.10.2 Insert set screw using short quick tube ► Completely take up the set screw a (SY001T/SY001TS) with the deformity set screw starter 7. To do so, insert the working end b into the socket of the set screw a and push with light pressure until the line marking c terminates flush with the surface, see Fig. 20. ► Verify solid seating of the set screw a on the deformity set screw starter 7. ► Place the set screw a with the set screw starter 7 aligned axially to the cannula of the tube and slide the set screw starter 7 through the cannula. ► Screw the set screw a into the head of the pedicle screw d from the top until the set screw a has contact with the rod e. ► Rotate set screw starter 7 clockwise while the set screw engages with the pedicle screw thread. ► Stop rotation when the set screw a tightens against the rod.

12

c d

Fig. 21 ► Push the Ennovate quick connect handle a (SZ224R) onto the hex

connection b of the set screw driver 6 up to the stop. ► Screw the set screw a into the head of the pedicle screw d from the top

until the set screw c has contact with the rod e. ► Rotate set screw driver 6 clockwise while the set screw engages with

the pedicle screw thread. ► Stop the rotation when the set screw c tightens against the rod.

CAUTION Operation delay! ► Do not pull the set screw driver SZ355R out of engagement with the set screw while connecting the torque wrench SZ228R to the set screw driver.

en 3.11 Insert and tighten set screw with deformity set screw driver Note The Ennovate deformity set screw driver 6 must be used when conducting the final tightening of constructs utilizing the derotation tube 11 or the long quick tube 1. WARNING Insufficient stabilization of the spinal column region to be treated due to under tightening the set screw! Risk of damage to the implant or instruments due to overtightening of the set screw! ► For the final tightening of the set screws and when activating PolyLock®, only use the 10 N∙m torque handle SZ228R. ► Check the recalibration/maintenance date on the torque wrench handle maintenance label prior to each use. ► When tightening or loosening the set screws, make sure that the working end of the torque wrench handle shaft is positioned entirely within the socket of the set screws. ► Apply the torque slowly and without sudden movement until the torque wrench handle release is audibly triggered. WARNING Injury to the patient from initiation of high torques on the spinal column! ► Always use a counter torque for the tightening of the set screw and when activating PolyLock®. ► Always completely and correctly insert the counter torque in the respective receptacle geometry. Check for the correct positioning. ► Hold the counter torque in position and do not twist or lever against the tube or the inserted rod. 3.11.1 Tighten set screw using long quick tube

3.11.2 Tighten set screw using short quick tube ► Remove the short quick tube 2 from the screw construct by pushing the two smaller gold buttons inward and pulling the gold knob until a hard stop is felt and the inner shaft no longer moves away from the rest of the instrument. –or– ► Remove the short quick tube 2 from the screw construct by rotating the gold knob counter clockwise until a hard stop is felt and the inner shaft no longer moves away from the rest of the instrument. a

c

Fig. 22 ► Push the 10 N∙m torque handle a (SZ228R) on to hex connection b of

the deformity set screw driver 6 up to the stop. ► Push the counter torque handle c (SZ282R) onto the top of the head of the pedicle screw or hook completely. Note The Counter Torque Holder can be placed in four different positions in 90 degree increments.

► Push the 10 N∙m torque handle a (SZ228R) onto the hex connection of

► Insert the torque handle assembly into the cannula of the counter

the set screw driver 6 up to the stop. ► Insert the set screw driver 6 into the cannulation of the long quick tube 1 and carefully push the set screw driver 6 down with light pressure into the socket of the set screw up to the stop. ► Engage the counter torque 5 (SZ335R) to the coupling geometry on the long quick tubes 1 which require final tightening. ► If needed, a segmental coupler 20 can be used as a counter torque handle during the final tightening. ► Screw in the set screw by turning the torque wrench SZ228R clockwise while firmly holding the segmental coupler 20 or counter torque handle 5 until the set screw SY001T/SY001TS engages with the screw head and an acoustic signal sounds. The sound is an indicator that the final tightening torque of 10 N∙m has been achieved. ► Remove the set screw driver 6 and torque wrench SZ228R assembly from the quick tube 1 by pulling the torque handle and shaft straight out of the tube. ► Repeat the procedure for additional screws.

torque holder and carefully push down with light pressure up to the stop. ► Final tighten the set screw by turning the 10 N∙m torque handle a clockwise. Hold the counter torque handle c (SZ282R) securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that a torque of 10 N∙m has been reached. ► Remove the torque handle assembly together with the counter torque holder SZ282R. ► Repeat the procedure for additional screws. 3.11.3 Tighten set screw using derotation tube and combo pusher ► Push the 10 N∙m torque handle a (SZ228R) onto the hex connection b of the set screw driver 6 up to the stop. ► Insert the set screw driver 6 into the cannula of the combo pusher 9 and carefully push the set screw driver 6 down with light pressure into the socket of the set screw up to the stop. ► Engage the counter torque handle 5 (SZ335R) to the coupling geometry on the derotation tube 11 which require final tightening. ► If needed, segmental couplers 20 can be used as counter torque handles during final tightening. ► Screw in the set screw by turning the torque wrench SZ228R clockwise while firmly holding the segmental coupler 20 or counter torque handle 5 until the set screw SY001T/SY001TS engages with the screw head and an acoustic signal sounds. The sound is an indicator that the final tightening torque of 10 N∙m has been achieved.

13

en ► Remove the set screw driver 6 and torque wrench SZ228R assembly

from the derotation tube 11 by pulling the torque handle and shaft straight out of the derotation tube. ► Repeat the procedure for additional screws. 3.11.4 Tighten set screw using derotation tube and rod pusher

18

19

a b 20 11

Fig. 24

Fig. 23 ► Push the 10 N∙m torque handle a (SZ228R) onto the hex connection b

of the deformity set screw driver 6 up to the stop. ► If the deformity set screw driver is not already engaged with the set

screw, carefully push it down with light pressure into the socket of the set screw up to the stop. ► Engage the counter torque handle 5 to the coupling geometry on the derotation tubes 11 which require final tightening. ► If needed, a segmental coupler 20 can be used as a counter torque handle during final tightening. ► Screw in the set screw by turning the torque wrench a (SZ228R) clockwise while firmly holding the segmental coupler 20 or counter torque handle 5 until the set screw SY001T/SY001TS engages with the screw head and an acoustic signal sounds. The sound is an indicator that the final tightening torque of 10 N∙m has been achieved. ► Remove the set screw driver 6 and the torque wrench a (SZ228R) assembly from the derotation tube 11 by pulling the shaft straight out of the tube. ► Repeat the procedure for additional screws.

3.12 Contour rod in-situ 3.12.1 Contour rod in sagittal plane The sagittal rod benders may be used to improve or adjust kyphosis and lordosis. The instruments have a straight connection interface and angled connection interface, which influences the bending radius and the outcome of the rod curvature.

► Place the rod interface of both sagittal rod benders 18 (SZ342R)

and 19 (SZ343R) on the rod section requiring bending. ► For small incremental bending it is recommended to place the working ends as close together as possible. ► By levering the upper portions of the sagittal rod benders 18 and 19 together, the rod is bent in a lordotic manner. By pulling the instruments away from each other the rod is bent kyphotically. 3.12.2 Contour rod in coronal plane The coronal rod benders 3 and 4 may be used to improve coronal plane correction. The coronal rod benders 3 and 4 have a connecting spindle which allow for the creation of large bending radii. If larger bending radii are needed, press the button on the spindle and adjust the distance between coronal benders 3 and 4. WARNING Danger of injury from damage (breakage) of the rod if bent incorrectly! Rod cannot be inserted into the tube! Rod cannot be fastened! ► Avoid severe rod bending in the region of the pedicle screw or hooks. ► Only bend rod with provided rod bending instruments. ► Do not bend rod multiple times at the same location. ► Do not bend rod back.

4

3

WARNING Danger of injury from damage (breakage) of the rod if bent incorrectly! Rod cannot be inserted into the tube! Rod cannot be fastened! ► Avoid severe rod bending in the region of the pedicle screw or hooks. ► Only bend rod with provided rod bending instruments. ► Do not bend rod multiple times at the same location. ► Do not bend rod back. Fig. 25 ► Place the interface of coronal rod benders 3 and 4 on the rod section

requiring bending.

14

en ► Arrange the handles of the coronal rod benders 3 and 4 such that the

female and male instrument parts can interact, if they are close enough for direct contact between instruments. ► Squeeze or pull apart the handles until the desired bend in the rod is achieved.

3.13 Place hook 3.13.1 Place pedicle hook CAUTION Operation delay! Damage to the hook, the set screw and the hook holder tube from loosening of the hook interlock from the hook holder tube! ► Check that the hook is solidly fastened. ► Visually inspect the correct seating of the support arms in the hook head. ► Divide the facet capsule, and resect a portion of the inferior facet pro-

cess to facilitate the hook placement. ► Prepare the hook placement using the pedicle preparator 15. Slide the

fork-shaped tip below the capsule of the facet joint and set the tip around the inferior part of the pedicle.

3.13.2 Place hook using lamina and transverse process CAUTION Operation delay! Damage to the hook, the set screw and the hook holder tube from loosening of the hook interlock from the hook holder tube! ► Check that the hook is solidly fastened. ► Visually inspect correct seating of the support arms in the hook head. The lamina elevator 14 or transverse process elevator 30 may be used to separate ligamentous attachments in order to insert the hook without constraints. ► Attach the desired hook to either the hook holder tube 12 by engaging the instrument to the implant interface. ► Visually inspect the correct connection between the hook and the hook holder tube 12. ► If needed, slide the hook pusher 13 into the hook head to support the hook placement. WARNING Inadequate fixation or damage to implants due to introduction of lateral forces! ► When tightening or loosening, only subject the set screws to torsion. ► Avoid exerting torsional or lateral forces when tightening or loosening set screws ► Once the rod has been seated, perform the final tightening, see Insert

12

Fig. 26 ► Attach the desired hook to the hook holder tube 12 by engaging the

instrument to the implant interface. ► Visually inspect the correct connection between the hook and the hook holder tube 12. ► If needed, slide the hook pusher 13 into the hook head to support the hook placement. ► Insert the pedicle hook directly towards the inferior pedicle. Ideally the pedicle hook should sit in a very stable position within the residual facet joint firmly against the pedicle. ► If needed, use a mallet to impact the hook pusher 13 to drive the pedicle hook. WARNING Inadequate fixation or damage to implants due to introduction of lateral forces! ► When tightening or loosening, only subject the set screws to torsion. ► Avoid exerting torsional or lateral forces when tightening or loosening set screws. ► Once the rod has been seated, perform the final tightening, see Insert

and tighten set screw with deformity set screw driver.

and tighten set screw with deformity set screw driver.

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.

15

en 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

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.

4.4

Preparing for cleaning

4.5

Disassembly

4.5.1

Table top rod cutter

b a

f

d

e

c

g

Fig. 27 ► Remove the legs f by pulling on them axially until the retaining force

is overcome and they are disengaged from the outer housing. ► Remove the threaded pin a by turning the pin counter-clockwise until the threading is disengaged and then pull it axially out of the outer housing b. ► Remove the worm gear c by pulling it axially out of the outer housing. ► Remove both cutting bushings d by turning them counter-clockwise until the threading is disengaged and then pulling them axially outward from the gear g and the outer housing b. ► Remove the spanner nut e by turning it counter-clockwise until the threading is disengaged from the outer housing. ► Remove the gear g from the outer housing b by pulling it axially out of the outer housing b. Note Replacement bushing screws for the table top rod cutter 26 may be ordered from your Aesculap representative as part number SZ330206. 4.5.2

Coronal Benders

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

e

c

a

d Fig. 28 ► Push and hold down the button a at the top to disengage the ratchet

mechanism.

16

en ► Pull apart the ratchet from the locking guide (the hole in the button a)

while holding down the button a at the top. ► Pull the ratchet locking guide off the handle c until the snap ring disengages. ► Pull the ratchet shaft d off the other handle e until the snap ring disengages.

4.6

Cleaning/Disinfection

4.6.1

Product-specific safety information on the reprocessing method Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastics 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 washing temperature of 60 °C. ► Use suitable cleaning/disinfecting agents if the product is put away in

a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically. 4.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection SZ330R, SZ333R, SZ335R, SZ342R, SZ343R, SZ344R, SZ345R, SZ346R, SZ347R, SZ348R, SZ349R, SZ350R, SZ351R, SZ352R, SZ353R, SZ354R, SZ355R, SZ358R

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with immersion disinfection

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

■ Drying phase: Use a lint-free cloth or medical compressed air. SZ330R/SZ344R/SZ345R: products must be disassembled prior to cleaning. Manual cleaning with ultrasound and immersion disinfection SZ328R, SZ329R, SZ334R, SZ336R, SZ337R, SZ338R, SZ339R, SZ340R, SZ341R, SZ357R, SZ359R

Chapter Manual cleaning/disinfection and sub■ Suitable cleaning brush section: ■ Disposable syringe 20 ml ■ Chapter Manual cleaning with ultrasound and ■ Keep working ends open for cleaning. immersion disinfection ■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air. SZ339R/SZ340R/SZ341R: – Phase I: Clean lumen with a suitable bottle brush in the solution until all discernible residues have been removed from the surface. – Phase II: rinse lumen with spray nozzle (3.8 bar water pressure) at least 3 times for 20 seconds.

17

en Validated procedure

Specific requirements

Reference

Mechanical alkaline cleaning and thermal disinfection SZ335R, SZ346R, SZ347R, SZ348R, SZ349R, SZ350R, SZ351R, SZ352R, SZ353R, SZ354R, SZ355R, SZ358R

■ Place the product on a tray that is suitable for

Chapter Mechanical cleaning/disinfection and subsection:

cleaning (avoid rinsing blind spots).

■ Connect components with lumens and chan- ■ Chapter Mechanical alkaline cleaning and nels directly to the rinsing port of the injector carriage.

thermal disinfecting

■ Keep working ends open for cleaning. ■ Place the product on the tray with all their hinges open.

■ SZ354R/SZ355R: The instrument must be subjected to manual pre-cleaning (using a brush) if bone or tissue residues or residues of additives are present. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection SZ328R, SZ329R, SZ330R, SZ333R, SZ336R, SZ337R, SZ338R, SZ342R, SZ343R, SZ342R, SZ343R, SZ344R, SZ345R, SZ357R

Chapter Mechanical cleaning/disinfection with ■ Suitable cleaning brush manual pre-cleaning and subsection: ■ Disposable syringe 20 ml ■ Chapter Manual pre-cleaning with a brush ■ Place the product on a tray that is suitable for ■ Chapter Mechanical alkaline cleaning and cleaning (avoid rinsing blind spots).

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product

thermal disinfecting

links and joints open.

■ SZ336R/SZ357R: Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ SZ330R/SZ344R/SZ345R: Products must be disassembled prior to cleaning. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection SZ332R, SZ339R, SZ334R, SZ340R, SZ341R, SZ359R

Chapter Mechanical cleaning/disinfection with ■ Suitable cleaning brush manual pre-cleaning and subsection: ■ Disposable syringe 20 ml ■ Chapter Manual pre-cleaning with ultrasound ■ Place the product on a tray that is suitable for and brush cleaning (avoid rinsing blind spots). ■ Chapter Mechanical alkaline cleaning and ■ Connect components with lumens and chanthermal disinfecting nels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open.

■ SZ339R/SZ340R/SZ341R: – Phase I: Clean lumen with a suitable bottle brush in the solution until all discernible residues have been removed from the surface. – -Phase II: rinse lumen with spray nozzle (3.8 bar water pressure) at least 3 times for 20 seconds.

18

en 4.7

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.

4.7.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, 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 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.

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.

19

en 4.7.2

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.

20