Ennovate – Instruments for open access

en

Aesculap® Ennovate Instruments for open access Legend

Contents

1 Ennovate pedicle awl SZ241R 2 Ennovate pedicle probe, lumbar, straight SZ242R 3 Ennovate pedicle probe, lumbar, curved SZ243R 4 Ennovate pedicle probe, thoracic, straight SZ244R 5 Ennovate pedicle probe, thoracic, curved SZ245R 6 Ennovate pedicle probe, lumbar, straight, large SZ263R 7 Ennovate pedicle probe, thoracic, straight, large SZ264R 8 Ennovate pedicle sounder, straight SZ246R 9 Ennovate pedicle sounder, curved SZ247R 10 Ennovate steel ruler AA804R 11 Ennovate pedicle marker, dual band SZ248R 12 Ennovate pedicle marker, single band SZ249R 13 Ennovate screw tap for ∅ 4.5 mm cannulated SZ254R 14 Ennovate screw tap for ∅ 5.5 mm cannulated SZ255R 15 Ennovate screw tap for ∅ 6.5 mm cannulated SZ256R 16 Ennovate screw tap for ∅ 7.5 mm cannulated SZ257R 17 Ennovate screw tap for ∅ 8.5 mm cannulated SZ258R 18 Ennovate screw tap for ∅ 9.5 mm cannulated SZ259R 19 Ennovate screw tap for ∅ 10.5 mm cannulated SZ260R 20 Ennovate screw driver SZ262R 21 Ennovate screw body manipulator SZ265R 22 Ennovate rod bending template, 300 mm SZ267SU 23 Ennovate french rod bender SZ270R 24 Ennovate rod holding forceps SZ272R 25 Ennovate rod pusher SZ273R 26 Ennovate rod pusher, forked, curved SZ275R 27 Ennovate counter torque holder for rod persuader SZ276R 28 Ennovate rod persuader SZ277R 29 Ennovate set screw driver SZ280R 30 Ennovate counter torque holder, L-shaped SZ282R 31 Ennovate torque wrench shaft, 10 Nm SZ283R 32 Ennovate cross connector holder SZ290R 33 Ennovate cross connector caliper SZ291R 34 Ennovate counter torque holder for connectors SZ292R 35 Ennovate rod-to-rod connector inserter SZ295R 36 Ennovate torque wrench shaft, 5 Nm SZ297R 37 Ennovate parallel distractor handle, open SZ233R 38 Ennovate parallel compressor handle, open SZ234R 39 Ennovate working tips, parallel, open SZ252R 40 Ennovate working tips, offset, open SZ253R 41 Ennovate injection cannula, open SR136SU 42 Ennovate sleeve for injection cannula, open SR137R 43 Ennovate injection cannula open long SR166SU 44 Ennovate sleeve for injection cannula open long SR167R 45 Ennovate PolyBlocker SZ393R 46 Ennovate/S4 percutaneous cleaning device FW692R 47 Ennovate set screw driver, short SZ391R

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

The depictions in this document are schematic representations only and may deviate from the actual product. 2

3.2 3.3 3.4 3.4.1 3.4.2 3.4.3

3.5 3.6 3.7 3.8 3.9 3.9.1 3.9.2 3.9.3 3.10 3.11 3.11.1 3.11.2 3.12 3.12.1 3.12.2 3.13 3.13.1 3.13.2 3.13.3 4. 4.1

About this document... Scope... Warnings... Clinical application... Areas of application and restrictions on use... Objective... Indications... Absolute contraindications... Relative contraindications... Safety instructions... Clinical user... Product specific safety information... Sterility... Operation... Prepare pedicle with pedicle awl SZ241R and pedicle probe SZ242R to SZ245R or SZ263R/SZ264R... Cut thread with screw taps SZ254R to SZ260R (optional) . . . Determine screw length with steel ruler AA804R and pedicle probes SZ246R/SZ247R... Screw in pedicle screw... Screw in pedicle screw with screw driver SZ262R... Align screw heads with screw body manipulator SZ265R and screw driver SZ262R... Secure the fenestrated pedicle screw with injection cannula SR136SU/SR166SU and sleeve for injection cannula SR137R/SR167R using bone cement (optional)... Determine rod length with rod bending template SZ267SU . . Adjust rod length with rod cutter FW206R... Bend rod with rod bending pliers SZ270R... Insert rod with rod holding forceps SZ272R... Push rod into screw head... Push rod into screw head with rod pusher SZ273R (option 1) Push rod with rod pusher SZ275R (option 2)... Push rod with rod persuader SZ277R (option 3)... Insert and tighten set screw temporarily with the insertion instrument for the set screw SZ280R (optional)... Insert and finally tighten set screw with torque wrench shaft SZ283R or set screw driver SZ391R... Finally tighten set screw after temporary insertion... Finally tighten set screw without temporary insertion and tightening... Carry out corrective maneuver (optional)... Perform distraction/compression (for option 1 and 2)... Perform parallel distraction/compression (for option 3)... Position the cross connector/rod-to-rod connector/offset connectors... Position cross connector... Position rod connectors... Position lateral-offset connectors... Validated reprocessing procedure... General safety instructions...

3 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 6 6 6 8

8 10 10 10 11 11 11 11 12 13 13 14 14 15 15 16 17 18 19 21 22 22

en 4.2 4.3 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 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 4.14 4.15 4.16 5. 6. 7.

General information... 22 Single-use products... 23 Reusable products... 23 Preparations at the place of use... 23 Preparation before cleaning... 23 Disassembling... 23 Screw driver SZ262R... 23 Rod persuaderrod persuader SZ277R... 23 Parallel distractor handle open SZ233R and parallel compressor handle open SZ234R... 23 Cross connector holder SZ290R... 23 Injection cannula open SR136SU/SR166SU and sleeve for injection cannula SR137R/SR167R... 24 Cleaning/disinfection... 24 Product-specific safety notes on the reprocessing procedure . 24 Validated cleaning and disinfection procedure... 25 Manual cleaning/disinfection... 26 Manual cleaning with immersion disinfection... 26 Manual cleaning with ultrasound and immersion disinfection 27 Mechanical cleaning/disinfecting... 28 Mechanical alkaline cleaning and thermal disinfecting... 28 Mechanical cleaning/disinfection with manual pre-cleaning . 28 Manual pre-cleaning with a brush... 28 Manual pre-cleaning with ultrasound and brush... 29 Mechanical alkaline cleaning and thermal disinfecting... 29 Inspection... 30 Visual inspection... 30 Function test... 30 Assembling... 31 Screw driver SZ262R... 31 Rod persuader SZ277R... 31 Cross connector holder SZ290R... 31 Packaging... 31 Steam sterilization... 31 Storage... 31 Technical Service... 31 Li-ion batteries... 31 Symbols on product and packaging... 31

1.

About this document

Note General risks of surgical interventions are not described in these instructions for use.

1.1

Scope

These instructions for use apply to all products listed in the key. Note The applicable CE mark for the product can be found on the label or packaging of the product. ► For article-specific instructions for use and information on material

compatibility, see Aesculap Extranet at https://extranet.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may emerge during the use of the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. If it is not prevented, minor or moderate injuries may result. CAUTION Indicates potential damage to property. If these are not prevented, the product may be damaged.

2.

Clinical application

2.1

Areas of application and restrictions on use

2.1.1 Objective The Ennovate instruments are used for the implantation of Ennovate Spinal System implants. 2.1.2 Indications Note Use of the product contrary to the indications mentioned above and/or described applications is outside the manufacturer's liability. Indications are described in the instructions for use of Ennovate implants TA014887. 2.1.3 Absolute contraindications Absolute contraindications are described in the instructions for use of Ennovate implants TA014887. 2.1.4 Relative contraindications Relative contraindications are described in the instructions for use for Ennovate implant TA014887.

3

en 2.2

Safety instructions

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. 2.2.2

Product specific safety information

► See instructions for use for the Ennovate handles TA015007 and

Ennovate implants TA014887 and operating manual O00702. ► Use only Aesculap Ennovate instruments and accessories. ► Hints on inserting the instruments into the supports: Observe the graphic/packing template. 2.2.3

Sterility

Non-sterile packaged products The product will be delivered non-sterile. ► Clean brand-new product after removal of the transport packaging and before the first sterilization. Sterile packaged products Art. no.

Designation

SR136SU

Ennovate injection cannula, open

The product is gamma-sterilized and supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use product after expiration date. Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not process product. Single use products Art. no.

Designation

SR136SU

Ennovate injection cannula, open

SZ267SU

Ennovate rod bending template 300 mm

► Do not reuse product.

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3.

Operation

WARNING Risk of injury and/or malfunction! ► Check product for loose, bent, broken, cracked, worn or missing parts before every application. ► Always carry out a function test prior to each use of the product. CAUTION Instrument can fall in situ or on the floor! Handle can loosen during use! ► Check the seating of the coupling handles on the instruments for tightness. ► When using K wires: Observe the following warning notices and usage

instructions for Ennovate MIS instruments TA014987. DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the 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 cannulization 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-wire. ► Insert K-wire in the correct direction, with the roughened end forward. ► Use only K-wires SZ369S, SZ369SU, SZ370 or SZ370SU of the Ennovate system. Note All handles and handle surfaces are black. All actuating elements that are actuated during the operation are gold colored. PolyLock® PolyLock® can be used to temporarily block the polyaxiality of a polyaxial pedicle screw by using specialized instruments from the Ennovate system without the need for a rod or a locking screw. In this way, the polyaxial screw temporarily becomes a monoaxial screw. The procedure for activating and deactivating PolyLock® is described in the relevant chapters of these instructions for use. PolyLock® can be activated and deactivated multiple times during instrumentation. Note PolyLock® does not necessarily have to be loosened before the final interlocking of the polyaxial screw using the rod and locking screw.

en 3.1

Prepare pedicle with pedicle awl SZ241R and pedicle probe SZ242R to SZ245R or SZ263R/SZ264R

Straight and bent pedicle probes for lumbar access (2, 3 and 6) as well as straight and bend pedicle probes for thoracic access (4, 5 and 7) are available for pedicle preparation.

8/9

11/12

WARNING Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! ► Insert pedicle probe carefully. Avoid levering and bending during insertion. ► Do not insert pedicle probe too deep. Verify suitable depth via radiographic control. Coordinate use to determined screw length. WARNING Revision required in case of screw loosening or pedicle break! ► Use pedicle probes 6 and 7 only for screws with ∅ 5.5 mm and larger. ► Carefully insert the pedicle preparator. Avoid levering and bending during insertion. ► Determine entry point and alignment of the pedicle screws.

Fig. 2 ► Verify integrity of the pedicle channel and cortex of the vertebral body:

Probe pedicle channel/cortex of vertebral body with pedicle probes 8/9. Particularly verify the first section of the pedicle channel (approx. 15 mm) when doing so. Note Alternatively, the instruments FW146R/FW147R can also be used.

1

► Optional: Use pedicle marker 11/12 as placeholder during the pedicle

2–7

preparation in order to determine the correct anatomical position under radiographic control.

3.2 a

Fig. 1 ► Perforate cortex with pedicle awl 1 (or with a ∅ <2.5 mm drill).

Note To determine the depth in the pedicle channel, the pedicle probes have ring markings a at 10 mm intervals. ► Prepare pedicle channel with pedicle probe 2 to 7 under radiographic

control to desired depth.

Cut thread with screw taps SZ254R to SZ260R (optional)

The Ennovate pedicle screws are self-cutting, with a continuous threaded tip. No thread cutting is usually required as a result. Screw taps are optionally available in various diameters, however. The screw taps have a smaller diameter than the corresponding screw. The color of the screw tap corresponds to the color of the corresponding screw. WARNING Revision required in case of screw loosening or pedicle break! Damage or breakage of instruments! ► Hold screw tap axially to the pre-prepared pedicle canal and to the K-wire when turning in and out. Avoid levering, bending and strong applications of force when doing so. ► Coordinate selection of screw diameter to the pedicle diameter. Use only screw tap in accordance with the screw diameter. Note In the case of large screw diameters, the thread must be cut to the nominal diameter by gradually raising the screw tap. Note The handles have a rotation direction setting in which the three positions of screw in (IN), locked (∙), and screw out (OUT) can be set.

5

en a a

a 8/9

b 8/9

13–19

a

13–19

c 10

13–19

a

Fig. 4 ► Insert pedicle probe 8/9 into pedicle channel and guide to end of pre-

pared screw hole by carefully probing.

Fig. 3 ► Push preferred handle a (SZ222R to SZ225R) onto the hex connection c

of the corresponding screw tap 13 to 19 up to the stop. ► Set rotation direction setting on the handle to "IN." ► Position screw tap 13 to 19 on previously prepared entry point and cut thread by rotating clockwise to required depth. ► Set rotation direction setting on the handle to "OUT." ► Unscrew screw tap 13 to 19 counter-clockwise. ► Verify integrity of the pedicle channel and cortex of the vertebral body: Probe pedicle channel/cortex of vertebral body with pedicle probes 8/9, see Fig. 2. ► Loosen screw tap 13 to 19 from the handle a. To do so, remove the black sleeve b on the handle and remove screw tap 13 to 19.

3.3

Determine screw length with steel ruler AA804R and pedicle probes SZ246R/SZ247R

The pedicle probe 8/9 is used to determine the required screw length. WARNING Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex! Faulty determination of screw length due to incorrect reading of scale! ► Always read screw length on the millimeter scale. Note The final selection of screw length and screw diameter must be made by the operator.

6

► Mark pedicle probe 8/9 at height of entry point to pedicle channel, e.g.

by placing and clamping a hemostat a. ► Remove pedicle probe from the pedicle canal. ► Determine length of the screw hole: Measure distance from the tip of

the pedicle probe to the marking with steel ruler 10. ► Select suitable screw diameter and suitable screw length according to

preoperative planning and intraoperative measurement.

3.4

Screw in pedicle screw

3.4.1 Screw in pedicle screw with screw driver SZ262R ► When using K wires: Observe the following warning notices and usage instructions for Ennovate MIS instruments TA014987. DANGER Injury to spinal cord, nerve root and blood vessels due to piercing of the cortex and faulty screw placement or inspection due to screw loosening when used improperly! ► Ensure axial alignment of the pedicle screw to the K-wire when screwing in. When doing this, make sure that the K-wire remains in its position. ► Remove K-wire before the screw is completely screwed in. ► Do not remove K-wire too early, as otherwise the pedicle screw guide will fail. WARNING Risk of injury to the patient if the pedicle screw is damaged while it is being removed from the packaging! ► When connecting the pedicle screw with the screwdriver SZ262R never brace against the packaging.

en CAUTION Operation delay! Damage to the pedicle screw, the set screw and by loosening the screw driver from the screw! Torque cannot be transferred! ► Connect screw driver completely to the screw. ► Check that the pedicle screw is securely fastened to the screwdriver. ► Verify the axial alignment of the pedicle screw to the screw driver. ► Before screwing the pedicle screw into the bone, retract the sleeve on the screw driver until it audibly latches. ► Hold screw driver axially to the pre-prepared pedicle canal when turning in and out. Avoid levering, bending and strong applications of force when doing so.

a a

d g 20

c d 20

a

a f f

a c d

d Fig. 6

b

► Before screwing the pedicle screw into the bone: Retract the sleeve d

20

20

e f

f

20 Fig. 5 ► Push preferred handle a (SZ222R to SZ225R) onto the hex

connection b of the screw driver 20 up to the stop. ► Make certain that the screw driver 20 is in the loading position. To do

so, press the gold colored push-button c and gold colored sleeve d forward toward the tip of the screw driver. ► Insert screw driver 20 into the pedicle screw until the tip e of the screw driver sits in the socket of the pedicle screw f and thus axially aligns to the screw shaft. ► Screw in screw driver 20 into the thread of the pedicle screw f up to the stop by rotating the gold colored sleeve d clockwise and tighten. ► In order to completely secure the connection between the screw and the screw driver, set the rotation direction setting on the handle a to locked (∙) and tension gold colored sleeve d by turning clockwise while bracing on the handle a. With polyaxial screws: Fastening is complete when the polyaxial alignment of the pedicle screw is completely blocked.

on the screw driver 20 until you hear it click into place. The gold colored sleeve d can then be freely rotated and used to guide the screw driver when screwing in. ► Set rotation direction setting on the handle a to "IN". ► Position screw driver 20 with fastened pedicle screw f to previously prepared entry point and screw in pedicle screw f under radiographic control to required depth by turning the screw driver 20 clockwise. ► Check correct screw height (how far the pedicle screw f protrudes from the vertebral body). Unscrew pedicle screw somewhat as necessary. To do so, set rotation direction setting on handle a to "OUT" and turn screw driver 20 counter-clockwise. ► When using polyaxial screws: Ensure that the polyaxial alignment of the pedicle screw is ensured and the screw body does not strike against any anatomical structures. ► Press the gold colored push-button c and gold colored sleeve d forward toward the tip of the screw driver 20. ► Unscrew screw driver out of the thread of the screw body by turning the gold colored sleeve d counter-clockwise and remove from the pedicle screw f. ► Remove the handle a from the screw driver 20 by actuating the black sleeve g. ► Verify position and size of the screws before placing the rod with intraoperative imaging.

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en 3.4.2

Align screw heads with screw body manipulator SZ265R and screw driver SZ262R

WARNING Screw in or unscrew polyaxial screw by alignment (axial twisting) of the pedicle screw after activation of PolyLock®! ► Do not axially twist the pedicle screw if the PolyLock® is activated. ► Align rod slots/rod grooves on the pedicle screw before activating the PolyLock®. WARNING Screwing in or unscrewing of monoaxial screw by alignment (axial twisting) of the clamping sleeve! ► Align rod slots/rod grooves of the monoaxial fenestrated pedicle screw before cementing. ► Align rod slots/rod grooves of the monoaxial pedicle screw under radiographic control.

21 21

WARNING Risk of injury from cement leakage! ► Always apply imaging techniques for control during the preparation and positioning of the implants. ► Make certain that the slots of the fenestrated Ennovate pedicle screw are positioned completely in the bone. ► Take care not to perforate the pedicle cortex. ► Do not penetrate the opposite cortex and ensure that the opposite cortex is undamaged. ► Do not insert or cement the fenestrated Ennovate pedicle screw in fractured or partially resected vertebral bodies. Carry out preoperative thin-section CT control. ► Insert and screw the injection cannula and sleeve for injection cannula into the screw head without exerting appreciable force. Make certain that the axes of the pedicle screw and the injection cannula are aligned with each other. ► Cement application must always be accompanied by high-quality, image-producing X-ray screening. Use no more than 2 ml of cement for each pedicle screw. Take the dead space volume of the injection cannula into consideration. WARNING Revision required! Loss of anchoring stability by alignment (axial twisting) of the fenestrated pedicle screw after cementing! ► Align rod slots/rod grooves of the monoaxial fenestrated pedicle screw before cementing. ► Do not twist threaded shaft of the polyaxial and monoaxial pedicle screws after cementing.

a a b

b

Fig. 7

WARNING Wound contamination due to insufficient curing of cement! Risk of set screw thread adhesion, resulting in system instability! ► Observe the correct curing time. ► For monitoring the cement texture, prepare a reference volume of cement together with the cement to be applied. ► Make certain the implant system is not exposed to any load before the cement has reached its final strength.

► With polyaxial screws: If necessary, align screw heads with screw body

manipulator 21. To do so, place the working end a of the screw body manipulator 21 on the head of the pedicle screw b. ► With monoaxial screws: Ensure that the screw heads are correctly aligned to each other with their rod slots so that the other instrumentation steps can be carried out. To do so, use screw driver 20, see Chapter 3.4.1. 3.4.3

Secure the fenestrated pedicle screw with injection cannula SR136SU/SR166SU and sleeve for injection cannula SR137R/SR167R using bone cement (optional) The injection cannulae and sleeves listed below can be combined to secure the fenestrated pedicle screw using bone cement: ■ Ennovate injection cannula open SR136SU with Ennovate sleeve for injection cannula open SR137R ■ Ennovate injection cannula open long for SR166SU with Ennovate sleeve for injection cannula open long for SR167R WARNING Surgery may be delayed in case of an incorrect combination of injection cannula and sleeve! ► Only use injection cannula with matching sleeve.

8

CAUTION Risk of injury due to material incompatibility! ► Only use application systems that have been approved for use with bone cement. CAUTION Damage to the pedicle screw, the injection cannula and delayed surgery due to loosening of the injection cannula from the pedicle screw and resulting replacement of the injection cannula! ► Completely connect the injection cannula and sleeve for injection cannula to the pedicle screw so that the marking line on the injection cannula terminates with the end of the sleeve for injection cannula. ► Check that the pedicle screw is solidly fastened to the injection cannula. ► Verify the axial alignment of the pedicle screw to the injection cannula.

en CAUTION Implant damage caused by the application of excessive shear forces with the injection cannula! ► Do not subject the injection cannula to transverse loads. ► Do not bend the injection cannula. CAUTION Inadequate fixation after removal of the application system due to incorrect viscosity of the cement! Contamination of the interlock thread! ► Make certain the cement has the correct viscosity. ► Follow the manufacturer’s instructions.

41/43

► Insert interconnected instrument 41+42 or 43+44 into the com-

pletely screwed-in pedicle screw a until the tip b of the injection cannula 41/43 is in the inner section of the screw head and is thus axially aligned with the screw shaft. ► Screw in sleeve for injection cannula 42/44 into the thread of the pedicle screw a turning it clockwise. Securely counter any movement at the broad surface c of the injection cannula 41/43 in doing so. With polyaxial screws: Fastening is complete when the polyaxial alignment of the pedicle screw is completely blocked. ► Prior to applying the bone cement: – Check that the injection cannula 41/43 is securely fastened to the pedicle screw a. – Verify the position of the pedicle screw a by an imaging process. ► Prepare the cement. Follow the usage instructions for the cement and applicator used. ► Check the bone cement for proper consistency and viscosity before positioning the applicator on the injection cannula 41/43. In doing so, observe the instructions of the manufacturer of the bone cement. ► Only cement the fenestrated Ennovate screw with a cement suitable for screw augmentation. Note The dead space volume of the injection cannula 41 is 0.6 ml. The dead space volume of the injection cannula 43 is 0.8 ml.

42/44

► Connect applicator to the Luer Lock connection d of the injection

cannula 41/43 from above. Check for secure connection. ► Carefully press the applicator and apply cement at low pressure. Make

b Fig. 8 ► Connect

injection cannula 41/43 to sleeve for injection cannula 42/44. To do so, insert injection cannula 41/43 at a slight angle through the tip of the sleeve 42/44 and pivot into the sleeve at the recessed location.

e

d

d

c 41/43 b

42/44

42/44

sure the applicator is axially aligned with the injection cannula 41/43. Avoid levering and positioning at an angle. ► Regularly verify with radiographic process during application of the bone cement. ► Apply cement until it escapes from the lateral slots of the pedicle screw. Avoid uncontrolled cement escape by continually observing under radiographic control. ► Continue to apply cement until a cement plume becomes visible. If necessary, press the remaining cement in the cannula using the plunger e. To do so, push the plunger e from above into the Luer Lock connection d of the injection cannula 41/43 and press downwards. ► Cement additional pedicle screws with the same procedure. ► Prior to the removal of the injection cannula 41/43: Allow the cement to fully cure. ► After the cement has completely cured: Remove injection cannula 41/43 and sleeve for injection cannula 42/44 from the pedicle screw a. To do so, loosen and remove the sleeve of the injection cannula 42/44 by turning the gold colored sleeve counter-clockwise while bracing on the broad surface of the injection cannula c from the pedicle screw a.

a

Fig. 9

9

en 3.5

Determine rod length with rod bending template SZ267SU

After the pedicle screws have been correctly placed, the required rod length can be determined with the rod bending template 22. Note The determination of rod length is only an estimate. The final selection of rod length must be made by the operator.

b

d

c 23 c

a

a

Fig. 11 ► Adjust desired bending radius on rod bending pliers 23: Pull rotary

knob a and set the desired radius by turning. ► Place rod b between rotary knob a and the two rollers c. Note The rod b has an orientation line that facilitates the alignment of the rod during the bending process.

22

Fig. 10 24

► Place rod bending template 22 in the heads a of the pedicle screws and

read off rod length. ► Take any subsequent distraction into account when determining the rod length.

3.6

b

Adjust rod length with rod cutter FW206R

► If necessary, cut the rod to desired length with rod cutter FW206R to

the proper length.

3.7

23

Bend rod with rod bending pliers SZ270R

If necessary, the rod can be bent with the rod bending pliers 23. Three different bending radiuses can be set on the rod bending pliers. Note Alternatively, the rod bending pliers FW024R can also be used with titanium rods. WARNING Danger of injury from damage (breakage) of the rod if bent incorrectly! Rod cannot be inserted into the clamping sleeve! Rod cannot be fastened! ► Avoid severe rod bending in the region of the pedicle screw. ► Only bend rod with provided rod bending pliers. ► Do not bend rod multiple times at the same location. ► Do not bend rod back.

10

Fig. 12 Note Fixing the rod b with the rod holding forceps 24 can prevent undesired rotation during the bending process. ► Bend rod b to the desired radius by actuating the handle d of the rod

bending pliers 5.

en 3.8

Insert rod with rod holding forceps SZ272R

CAUTION Operation delay! Loss of the rod in situ due to incomplete coupling of the rod to the rod holding forceps or early release of the interlock and incorrect alignment of the rod slots of the pedicle screw! ► Receive rod completely in jaw part of the rod holding forceps and clamp securely. ► Do not release clamping until the rod is correctly placed in the screw heads. ► Align rod slots/rod grooves of the pedicle screw before insertion of the rod.

25

d

b a

b Fig. 14 ► Place rod pusher 25 on rod a and push rod into the head of the pedicle

screw b. ► Continue see Chapter 3.10 or see Chapter 3.11.2.

24

c a

Fig. 13

3.9.2 Push rod with rod pusher SZ275R (option 2) The rod pusher 26 can be used for rod pushing with low height offset. DANGER Risk of severe injury! Pedicle screw can tear out of the spinal column if too much force is applied when pushing the rod! Revision required in case of rod break! ► Ensure that the forces applied when levering with rod pusher are not excessively high. ► Ensure that no notching occurs on the rod due to forces being too high.

► Receive rod a with rod holding forceps 24 and clamp by pressing the

handle parts b together. ► Insert rod a in the rod slots c of the pedicle screws. ► Relieve lock d of the rod holding forceps 24 by pressing the handle

parts b together and fold back. ► Remove rod holding forceps 24 from the rod a.

3.9

Push rod into screw head

3.9.1

Push rod into screw head with rod pusher SZ273R (option 1)

WARNING Operation delay! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Push rod down completely up to the stop in the screw head with rod pusher. ► Make certain and check that the rod is positioned securely in the screw head.

CAUTION Operation delay! Instrument slips from screw head! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Insert rod pusher correctly forked in the interface on the screw head. Check correct positioning. ► Push rod down completely up to the stop in the screw head with rod pusher forked. Make certain and check that the rod is positioned securely in the screw head.

11

en a g a g b

c

28 26

26 a d b

d

c

e f

Fig. 15 ► Insert pins a on the distal working end of the rod pusher 26 into the

interface on the head of the pedicle screw b. Check correct seating in the interface on the screw head. ► Fix rod pusher 26 by pushing the handle parts c together on the head of the pedicle screw b. ► Push rod pusher 26 toward rod d and push rod d up to the stop in the head of the pedicle screw b. ► Continue, see Chapter 3.10 or see Chapter 3.11.2. 3.9.3 Push rod with rod persuader SZ277R (option 3) In the case of a large height offset, the rod persuader 28 can be used. DANGER Risk of severe injury! Pedicle screw can tear out of the 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 threaded spindle of the rod persuader to the line marking are not excessive. When the line marking is reached, the forces are no longer transmitted to the pedicle screw, but rather converted into the interlock of the polyaxialilty (PolyLock®). CAUTION Operation delay! Instrument slips from screw head! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Insert rod persuader correctly into the interface on the screw head. Check correct positioning. ► Push rod completely up to the stop in the pedicle screw by turning the threaded spindle of the rod pusher forceps until the line marking terminates on the threaded spindle flush with the housing of the rod persuader. Observe and verify correct rod position in the head of the pedicle screw.

12

Fig. 16 ► Ensure that the rod persuader 28 is in the starting position:

– Option 1: Rotate the threaded spindle a counter-clockwise all the way to the stop. – Option 2: Press push-button b and pull threaded spindle a completely out up to the stop. ► Place rod persuader 28 on the head of the pedicle screw c and latch lateral catches d completely in the interface on the head of the pedicle screw c until an acoustic signal is audible. ► Visually inspect connection. In case of faulty assembly, the next step cannot be performed. Repeat step as required. ► Press threaded spindle a down or screw in by rotating clockwise until the reduction sleeve e sits on the rod f. ► Turn threaded spindle a further clockwise until the rod f is completely countersunk in the head of the pedicle screw c. ► The rod f is completely in the screw head when the line marking g on the threaded rod a terminates flush with the housing of the rod persuader 28. Note The rod persuader 28 can still be moved along the rod f and tilted slightly in order to carry out any necessary distraction or compression maneuvers. ► Continue, see Chapter 3.11.2.

en 3.10 Insert and tighten set screw temporarily with the insertion instrument for the set screw SZ280R (optional) If the rod was previously pushed with the rod pusher 25 (option 1) or the rod pusher 26 (option 2), the set screw can be temporarily inserted before the final fixating. 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 axially to the head of the pedicle screw and do not tilt.

29

25

29

29

a

c

26

e

d

e

WARNING Insufficient stabilization of the spinal column region to be treated due to undertightening the set screw! Risk of damage to the implant or instruments due to overtightening of the set screw! ► For the final tightening of the locking screws and when activating PolyLock®, use only 10 Nm 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 certain 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 patient from initiation of high torques on the spinal column! ► Always use the counter holder for tightening the locking screw and when activating PolyLock®. ► Always completely and correctly insert the brace in the respective receptacle geometry. Check correct positioning. ► Hold brace in position and do not twist or lever against the rod persuader or the inserted rod.

c b

29

3.11 Insert and finally tighten set screw with torque wrench shaft SZ283R or set screw driver SZ391R

d a

a

a

Fig. 17 ► Completely take up set screw a (SY001T/SY001TS) with the insertion

instrument for the set screw 29. 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. ► Verify solid seating of the set screw a on the insertion instrument 29. ► Place set screw a with insertion instrument 29 aligned axially to the head of the pedicle screw d and screw into the head of the pedicle screw d from the top until the set screw a contacts the rod e. ► Continue, see Chapter 3.11.2.

31/47 b

31/47

Fig. 18 Note The insertion instrument for the locking screw 47 can only be used if the rod was previously pushed with the rod pusher 25 (option 1) or the rod pusher26 (option 2). ► Slide 10 Nm

torque handle a (SZ228R) all the way onto hex connection b of the shaft for torque wrench 31 (for options 1-3) or insertion instrument for locking screw 47 (only for options 1 and 2).

13

en 3.11.1 Finally tighten set screw after temporary insertion Note This section is relevant if the set screw was already temporarily inserted and tightened, see Chapter 3.10.

3.11.2 Finally tighten set screw without temporary insertion and tightening Note This section is relevant if the set screw was not temporarily inserted and tightened. After pushing rod with rod pusher SZ273R (option 1) or rod pusher SZ275R (option 2)

30

b

31/47

31/47

c b

e

30

a

31/47

31/47

30

a c a d Fig. 19 ► Fully insert counter holder 30 from above on the head of the pedicle

screw a, and in the correct position. Note The counter torque holder 30 can be placed in four different positions. ► Insert shaft for torque wrench 31 or insertion instrument for locking

screw 47 into cannulation of the counter holder 30 and carefully slide it downwards applying light pressure all the way into the inner section of the locking screw. ► Screw in the set screw by turning the 10 Nm torque handle b clockwise. Hold the brace handle 30 securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that 10 Nm has been reached. ► Remove shaft for torque wrench 31 or insertion instrument for locking screw 47 conjointly with bracing instrument 30. ► Repeat procedure for additional screws.

Fig. 20 ► Completely take up locking screw a using shaft for torque wrench 31

or insertion instrument for locking screw 47. To do so, insert the working end b into the inner section of the locking screw a and slide inside exerting light pressure until the line marking c terminates flush with the surface. ► Verify secure seat of the locking screw a on the shaft for torque wrench 31 or insertion instrument for locking screw 47. ► Fully insert counter holder 30 from above on the head of the pedicle screw d, and in the correct position. Note The counter torque holder 30 can be placed in four different positions. ► Insert the shaft for the torque wrench 31 or insertion instrument for

locking screw 47 having a mounted locking screw a into the cannulation of the counter holder 30 and carefully guide it downwards onto the head of the pedicle screw d. ► Screw in the set screw by turning the 10 Nm torque handle e clockwise. Hold the brace handle 30 securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that 10 Nm has been reached. ► Remove shaft for torque wrench 31 or insertion instrument for locking screw 47 conjointly with bracing instrument 30. ► Repeat procedure for additional screws. After pushing rod with rod persuader SZ277R (option 3) WARNING Revision required! Inadequate fixation from screwing in at an angle/tilting of set screw! ► Do not strain rod pressing forceps crosswise to the rod axis (mediolateral axis) when inserting the set screw.

14

en 3.12 Carry out corrective maneuver (optional)

31 f c b a

Note Alternatively, the distraction instruments FW181R/FW023R or the compression instruments FW184R/FW210R can also be used.

31

h d g

27

28 i 31

c a

If necessary, the distraction or compression can be performed with the distraction instrument FW281R or the compression instrument FW282R or with the parallel distractor handle 37 or with the parallel compressor handle 38 and the work ends parallel 39 or work ends offset 40 attachments.

e

Fig. 21 ► Completely take up set screw a with torque wrench shaft 31. 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. ► Push counter torque holder 27 from the top on the coupling geometry d on the housing of the rod persuader 28. Note The counter torque holder for rod persuader 27 can be placed in eight different positions. ► Insert torque wrench shaft 31 with mounted set screw a into the can-

nulization of the rod persuader 28 and carefully guide down onto the head of the pedicle screw e. ► Screw in the set screw by turning the 10 Nm torque handle f clockwise. Hold the brace handle 27 securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that 10 Nm has been reached. ► Remove torque wrench shaft 31 from rod persuader 28. ► Repeat procedure for additional screws. ► Move rod persuader 28 to the starting position: Press push-button b and pull threaded spindle h completely out up to the stop. ► Press both gold colored levers i on the housing of the rod persuader 28 simultaneously and remove rod persuader 28 from the pedicle screw and remove from the site. Note The rod persuader 28 can only be decoupled from the pedicle screw if the threaded spindle h is in the starting position up to the stop.

WARNING Insufficient treatment or stabilization of the spinal column region to be treated! Damage to the implant and/or instruments! ► For final tightening of the locking screws and for activating PolyLock® use only 10 Nm torque handle SZ228R. ► Before every corrective maneuver: Verify 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 torques on the spinal column! ► When tightening the locking screw and when activating the PolyLock®, always counteract any movement securely using counter holder for rod persuader or L-shaped counter holder. ► Hold the counter torque holder for rod persuader or L-shaped counter torque holder in position and do not twist against the rod persuader or the inserted rod. ► Avoid excessive distraction or compression. CAUTION Screw in or unscrew polyaxial screw by alignment (axial twisting) of the rod persuader after activation of PolyLock®! ► Do not axially twist the rod persuader if the PolyLock® is activated. ► Always align the rod slots/rod grooves of the rod persuader before PolyLock® is activated. ► Perform operation steps up to and incl. pushing the rod, see

Chapter 3.9. 3.12.1 Perform distraction/compression (for option 1 and 2) Note The described procedure can only be performed if the rod was pushed into the screw head with the rod pusher 25 (option 1) or rod pusher 26 (option 2). ► Select desired starting point of distraction/compression. ► Make certain that the rod is completely inserted into the head of the

pedicle screw. ► Finally tighten first set screw, see Chapter 3.11, in order to be able to

use it as an anchor point for the distraction or compression. ► Loosen or leave loose adjacent set screw while bracing with the corre-

sponding brace 27/30 in order to be able to start the distraction/compression process.

15

en e

39/40

a

f

37/38

3.12.2 Perform parallel distraction/compression (for option 3) Note The described procedure can only be performed if the rod was pushed into the screw head with the rod pusher 28 (option 3).

Fig. 22

WARNING Revision required! Inadequate fixation from screwing in at an angle/tilting of set screw! ► Do not strain rod pressing forceps crosswise to the rod axis (mediolateral axis) when inserting the set screw.

► When using the parallel compressor handle 37 or parallel distractor

► Select desired starting point of distraction.

handle 38, couple desired attachments work ends parallel 39 or work ends offset 40 before the maneuver: Retract coupling sleeves a and push on attachments 39/40.

pedicle screws to be distracted/compressed and the rod is inserted down into the heads of the pedicle screws. ► Finally tighten first set screw, see Chapter 3.11, in order to be able to use it as an anchor point for the distraction or compression. ► Loosen or leave loose adjacent set screw while bracing with the counter torque holder for rod persuader 27 in order to be able to start the distraction process.

f

f e

► Ensure that rod persuader 28 are completely fixed on the heads of the

e a

b

c

a

45 c

28

d

d

27

b 45

Fig. 23 Fig. 24 ► Place distraction instrument b (SZ233R/FW281R) or compression

instrument c (SZ234R/FW282R) next to the heads of the pedicle screws up to the rod d. ► Perform desired distraction or compression by pushing handle parts e together. The distraction/compression is held on the instruments by the lock f. ► Secure distraction/compression: Tighten set screw, temporarily, see Chapter 3.10 or finally, see Chapter 3.11. ► Release lock f by folding back and remove distraction/compression instrument b/c. ► Repeat procedure for additional corrective maneuvers. ► After completing the corrective maneuver: Finally tighten all set screws, see Chapter 3.11.

16

► For polyaxial screws: Deactivate PolyLock®:

– Push ccounter holder for rod persuader 27 from above onto the coupling geometry on the housing of the rod persuader 28. – Slide 10 Nm torque handle a (SZ228R) all the way onto the hex connection b of the Polyblocker 45. – Insert 10 Nm a torque handle including mounted Polyblocker 45 from above all the way into the threaded spindle c of the rod persuader 28. – Turn the 10 Nm torque handle a clockwise to activate PolyLock®. Hold the handle of the counter holder 27 securely in its position until the acoustic signal of the triggering torque handle is heard. The acoustic signal indicates that PolyLock® is activated. – Remove 10 Nm torque handle a including mounted Polyblocker 45 from the rod persuader 28.

en c j

a

39/40

d

37/38 28

45 c

k

Fig. 25 28

► When using the parallel compressor handle 37 or parallel distractor

27

handle 38, couple desired attachments work ends parallel 39 or work ends offset 40 before the maneuver: Retract coupling sleeves d and push on attachments 39/40.

Fig. 27

i h

► For polyaxial screws: Deactivate PolyLock®:

a 31 e/f 28

27

g Fig. 26 ► Place distraction instrument e (SZ233R/FW281R) or compression

instrument f (SZ234R/FW282R) next to the heads of the pedicle screws up to the rod g. ► Perform desired distraction or compression by pushing handle parts h together. The distraction/compression is held on the instruments by the lock i. ► Secure distraction/compression: Tighten set screw, temporarily, see Chapter 3.10 or finally, see Chapter 3.11. ► Release lock i by folding back and remove distraction/compression instrument e/f. ► After completing the corrective maneuver: Finally tighten all set screws, see Chapter 3.11. ► Remove torque wrench shaft 31 from rod persuader 28.

– Push counter holder for rod persuader 27 from above onto the coupling geometry on the housing of the rod persuader 28. – Slide 10 Nm torque handle a (SZ228R) all the way onto the hex connection b of the Polyblocker 45. – Insert 10 Nm torque handle a including mounted Polyblocker 45 from above all the way into the threaded spindle c of the rod persuader 28. – Turn the 10 Nm torque handle a counter-clockwise to deactivate PolyLock®. Hold the counter holder handle 27 securely in position until the threaded spindle c of the rod persuader 28 can be rotated without significant resistance. – Remove the 10 Nm torque handle a including mounted Polyblocker 45 and the counter holder for rod persuader 27 from the rod persuader 28. ► Move rod persuader 28 to the starting position: Press push-button j and pull threaded spindle c completely out up to the stop. ► Press both gold colored levers k on the housing of the rod persuader 28 simultaneously and remove rod persuader 28 from the pedicle screw and remove from the site. Note The rod persuader 28 can only be decoupled from the pedicle screw if the threaded spindle c is in the starting position up to the stop. ► Repeat procedure for additional corrective maneuvers.

3.13 Position the cross connector/rod-to-rod connector/offset connectors WARNING Inadequate fixation due to incorrect rod position! ► Always position the rod-to-rod connectors/cross connectors/offset connectors in such a way that the rod is completely inserted into the rod-to-rod connectors/cross connectors/offset connectors. ► Always position MIS rods in such a way that the end of the hexagon and tip of the rod are located outside the clamping area of the rodto-rod connector/cross connector/offset connector.

17

en WARNING Inadequate fixation or damage to implants due to introduction of lateral forces! ► When tightening or loosening, only subject the set screws to axial pressure. ► Avoid exerting lateral forces when tightening or loosening the set screws.

3.13.1 Position cross connector The combination of a rod-screw construct with additional cross connectors can lead to increased rotational stability of the overall construct. In the case of shorter constructs, the use of cross connectors is optional; in the case of extended instrumentation, they should be used to increase the rigidity of the construction.

WARNING Risk of injury if rod-to-rod connector is positioned incorrectly! ► Always follow the correct sequence of steps when tightening the set screw. ► Check correct positioning. WARNING Risk of damage to the implant due to overtightening of the locking screw! Insufficient fixation due to undertightening or overtightening of the set screw! ► Check the recalibration/maintenance date on the torque wrench handle maintenance label prior to each use. ► When tightening or loosening the set screws, make certain that the working end of the torque wrench handle shaft 5 Nm 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. ► For final tightening of the set screws of the rod-to-rod connectors/cross connectors/offset connectors, use only 5 Nm torque handle SZ229R. ► Position the rod-to-rods/cross connectors/offset connectors correctly. ► Make certain that the rods are completely inserted into the rodto-rod connectors/cross connectors/offset connectors. ► Make certain that there is no soft tissue caught in the rod-to-rod connectors/cross connectors/offset connectors. WARNING Injury to patient from initiation of high torques/forces on the spinal column! Damage to the instruments! ► Always use the respective counter torque holder when tightening a set screw. ► Do not use cross connector holder and rod-to-rod connector inserter as brace. ► Hold brace in position and do not twist or lever against the rod-torod connector/cross connector/offset connector. CAUTION Rod-to-rod connector/cross connector is unusable if set screws are removed or not present! ► Do not unscrew the set screws from the rod-to-rod connectors/cross connectors/offset connectors in any case. ► Do not swap set screws with other components of the rod-to-rod connectors/cross connectors/offset connectors. ► Only use rod-to-rod connectors/cross connectors/offset connectors if all the set screws are present.

18

b

e

32

33

a

c d Fig. 28 ► Determine length of the cross connector to be used with cross connec-

tor caliper 33. To do so, place measuring instrument 33 between both rods a and read length on scale b. ► Choose cross connector c based on the measured length and the individual anatomy of the patient. Before installation of the cross connector, ensure the following in order to prevent blocking during attachment on the rods: – Cross connectors c can be freely placed. – Set screws d of the cross connectors are completely loosened. ► Press handle parts e and take up cross connector c with cross connector holder 32.

en d

c

g f

32

h 36 Fig. 31

c

► Tighten set screw d by turning the 5 Nm torque handle g clockwise.

a

Hold the counter torque holder 34 securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that 5 Nm has been reached. ► Remove 5 Nm torque handle g together with shaft 36 and counter torque holder 34. ► Repeat procedure for additional set screws d. ► Press handle parts e, pivot block j down and remove cross connector holder 32 from cross connector c.

Fig. 29 ► Place cross connector with holding forceps 32 on both rods a. Before

tightening up the locking screws, ensure that the cross connector c is positioned correctly. ► Retract sleeve f and push 5 Nm torque handle g (SZ229R) onto the square connection h of the torque wrench shaft 36 up to the stop.

3.13.2 Position rod connectors An existing supply can be extended or a connection created to an offset screw with rod connectors. There are multiple variants of rod connectors. Axial rod connectors ► Determine length of the rod connector with rod bending template 22

or cross connector caliper 33.

j

► Choose rod connector a based on the measured length and the individ-

ual anatomy of the patient. Before installation of the rod connector, ensure the following in order to prevent blocking during attachment on the rods: – Rod connectors a can be freely placed. – Set screws b of the rod connectors are completely loosened.

g 36

g 34 36

32

i 34

b e g f

c a

h 36

35 a i d Fig. 30

a

► Insert 5 Nm torque handle g with mounted shaft 36 into cannulization

of the counter torque holder for connectors 34 until the tip i of the shaft 36 protrudes slightly out of the counter torque holder 34. ► Place shaft 36 on set screw d and push with light pressure up to the stop in the socket of the set screw d. ► Place counter torque holder 34 completely on cross connector c.

Fig. 32 ► Receive rod a with rod-to-rod connector inserter 35 and clamp by

pressing the handle parts c together. ► Place rod connector a up to its center on the rod to be extended d.

The rod position can be verified with the viewing window e in the rod connector a. ► Retract sleeve f and push 5 Nm torque handle g (SZ229R) onto the square connection h of the torque wrench shaft 36 up to the stop.

19

en Parallel rod connectors ► Determine length of the rod connector with rod bending template 22 or cross connector caliper 33. ► Choose rod connector a based on the measured length and the individual anatomy of the patient. Before installation of the rod connector, ensure the following in order to prevent blocking during attachment on the rods: – Rod connectors a can be freely placed. – Set screws b of the rod connectors are completely loosened.

36

b a g

a

a e b

j

Fig. 33

i

► Temporarily tighten set screw b on the side of the rod to be extended d

with torque wrench shaft 36. ► Press handle parts c, loosen block i and remove inserting instrument for rod connector 35 from rod connector a. ► Once all implants of the extension are placed, insert extension rod j up to the stop in rod connector a. ► Temporarily tighten set screw b on the side of the extension rod j with torque wrench shaft 36. ► Verify correct position of rods in the viewing window e of the rod connector a. Once the rod connector a is correctly placed, the set screws b can be finally tightened.

35

h

Fig. 35

e

g g

d

36 36

c

34

e 36

f 36 a

34 b a k

Fig. 34

Fig. 36

► Insert 5 Nm torque handle g with mounted shaft 36 into cannulization

► Receive rod a with rod-to-rod connector inserter 35 and clamp by

of the counter torque holder for connectors 34 until the tip k of the shaft 36 protrudes slightly out of the counter torque holder 34. ► Place shaft 36 on set screw b and push with light pressure up to the stop in the socket of the set screw b. ► Place counter torque holder 34 completely on rod connector a. ► Tighten set screw b by turning the 5 Nm torque handle g clockwise. Hold the counter torque holder 34 securely in position until the acoustic signal of the triggering torque handle sounds. The acoustic signal indicates that 5 Nm has been reached. ► Remove 5 Nm torque handle g together with shaft 36 and counter torque holder 34. ► Repeat procedure for additional set screws b.

20

pressing the handle parts c together. ► Retract sleeve d and push 5 Nm torque handle e (SZ229R) onto the

square connection f of the torque wrench shaft 36 up to the stop. ► For rod connectors with one open and one closed rod hole:

– Place rod connector with closed rod hole on rod to be extended g. – Temporarily tighten set screw b on the side of the rod to be extended g with torque wrench shaft 36. – Once all implants of the extension are placed, insert extension rod h in open rod hole of the rod connector a. – Temporarily tighten set screw b on the side of the extension rod h with torque wrench shaft 36.