Ennovate – Instruments for MIS access

en

Aesculap® Ennovate Instruments for MIS access Legend

Contents

1 Ennovate parallel distractor forceps SZ231R 2 Ennovate parallel compressor forceps SZ232R 3 Ennovate screw tap for ∅ 4.5 mm to 10.5 mm SZ254R to SZ260R 4 Ennovate MIS bone access needle, short SZ364SU 5 Ennovate french rod bender, adjustable SZ270R 6 Ennovate MIS K-wire trocar, short SZ365R 7 Ennovate MIS K-wire sleeve, short SZ366R 8 Ennovate MIS K-wire forceps SZ367R 9 Ennovate MIS slotted hammer SZ368R 10 Ennovate MIS K-wire steel SZ369S, Ennovate MIS K-wire steel, sterile SZ369SU, Ennovate MIS K-wire nitinol SZ370, Ennovate MIS K-wire nitinol, sterile SZ370SU 11 Ennovate MIS skin incision guide SZ371R 12 Ennovate MIS dilator, S SZ372T 13 Ennovate MIS dilator, M SZ373T 14 Ennovate MIS dilator, L SZ374T 15 Ennovate MIS dilator handle SZ375T 16 Ennovate MIS pedicle probe lumbar, straight SZ376R 17 Ennovate MIS screw length measuring device SZ377R 18 Ennovate MIS downtube, short SZ378R/Ennovate FRI downtube SZ405R 19 Ennovate MIS locking wrench for downtube SZ379R 20 Ennovate MIS removal key, short SZ380R 21 Ennovate MIS screwdriver, short SZ381R 22 Ennovate MIS rod length caliper, short SZ382R 23 Ennovate MIS rod inserter, short SZ384R 24 Ennovate MIS rod inserter, long SZ385R 25 Ennovate MIS rod indicator, short SZ387R 26 Ennovate MIS parallel sleeve SZ388R 27 Ennovate MIS rod pusher, short SZ389R 28 Ennovate MIS rod pusher handle SZ390R 29 Ennovate set screw driver, short SZ391R 30 Ennovate MIS counter torque handle SZ392R 31 Ennovate PolyBlocker SZ393R 32 Ennovate MIS compression/distraction device SZ394T 33 Ennovate MIS C-Ring for compression/distraction device SZ395R 34 Ennovate MIS cage sleeve SZ396R 35 Ennovate MIS quick rod pusher, short SZ397R 36 Ennovate MIS alignment working port, short SZ398P 37 Ennovate MIS alignment tool, short SZ399R 38 Ennovate injection cannula MIS SR138SU 39 Ennovate cannula sleeve MIS SR139R

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

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

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3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.8.1 3.8.2

3.9 3.10 3.11 3.12 3.13 3.14 3.14.1 3.14.2 3.15 3.15.1 3.15.2 3.15.3 3.16

About this document... 3 Scope... 3 Warnings... 3 Clinical application... 4 Areas of application and restrictions on use... 4 Intended purpose... 4 Indications... 4 Absolute contraindications... 4 Relative contraindications... 4 Safety instructions... 4 Clinical user... 4 Product... 4 Sterility... 4 Safe operation... 5 Place K-wire... 5 Place K-wire with bone access needle SZ364SU... 5 Place K-wire with K-wire targeting device (SZ365R and SZ366R)... 6 Perform skin incision with skin incision guide SZ371R... 6 Perform dilation with dilator SZ372T to SZ374T and dilator handle SZ375T... 6 Enlarge pedicle canal with pedicle probe SZ376R... 7 Cut thread with screw tap SZ254R to SZ260R (optional)... 7 Determine screw length with screw length measuring device SZ377R... 8 Couple downtube SZ378R/SZ405R to pedicle screw... 8 Screw in pedicle screw... 8 Screw in pedicle screw with screwdriver SZ381R... 8 Screw in fenestrated pedicle screw with injection cannula SR138SU and cannula sleeve SR139R and fix with bone cement... 9 Determine rod length with rod length caliper SZ382R... 11 Adjust rod length with rod cutter FW206R... 11 Bend rod with french rod bender SZ270R... 11 Insert rod with rod inserter SZ384R/SZ385R... 12 Verify rod with rod indicator SZ387R... 13 Push rod into screw head... 13 Push rod into screw head with quick rod pusher SZ397R (option 1)... 13 Push rod into screw head with rod pusher SZ389R (option 2) 13 Insert and tighten set screw with the insertion instrument for the set screw SZ391R... 14 Take up set screw... 14 Insert and tighten set screw with MIS quick rod pusher SZ397R (option 1)... 15 Insert and tighten set screw with rod pusher SZ389R (option 2) 15 Remove downtube SZ378R/SZ405R with removal key SZ380R 15

en 3.17 Carry out corrective measure (optional)... 16 3.17.1 Prepare distraction/compression... 16 3.17.2 Perform parallel distraction/compression with parallel distractor forceps SZ231R and parallel compressor forceps SZ232R (option 1)... 16 3.17.3 Perform distraction with compression/distraction device SZ394T (option 2)... 17 3.18 Interbody fusion management: distraction/compression with alignment tool SZ399R and cage sleeve SZ396R (optional) . . 18 3.18.1 Remove downtube SZ378R/SZ405R... 18 3.18.2 Perform distraction/compression... 19 3.19 Recouple downtube after cage implantation... 19 3.19.1 Insert alignment working port SZ398P... 19 3.19.2 Recouple downtube SZ378R/SZ405R with alignment tool SZ380R... 20 3.20 Recouple downtube SZ378R/SZ405R after accidental decoupling... 21 3.20.1 Couple alignment tool SZ399R... 21 3.20.2 Recouple downtube SZ378R/SZ405R... 21 4. Validated reprocessing procedure... 22 4.1 General safety instructions... 22 4.2 General information... 22 4.3 Single-use products... 22 4.4 Reusable products... 22 4.5 Preparations at the place of use... 22 4.6 Preparation before cleaning... 22 4.7 Disassembling... 23 4.7.1 Parallel distractor forceps SZ231R and parallel compressor forceps SZ232R... 23 4.7.2 K-wire trocar SZ365R and K-wire sleeve SZ366R... 23 4.7.3 Skin incision guide SZ371R... 23 4.7.4 Downtube SZ378R/SZ405R... 23 4.7.5 Screwdriver SZ381R... 23 4.7.6 Rod length measuring instrument for short construction SZ382R... 24 4.7.7 Rod inserter for short construction SZ384R... 24 4.7.8 Rod inserter for long construction SZ385R... 24 4.7.9 Alignment working port SZ398P... 24 4.7.10 Alignment tool SZ399R... 24 4.7.11 Injection cannula SR138SU and cannula sleeve SR139R... 24 4.8 Cleaning/disinfection... 25 4.8.1 Product-specific safety notes on the reprocessing procedure . 25 4.8.2 Validated cleaning and disinfection procedure... 25 4.9 Manual cleaning/disinfection... 27 4.9.1 Manual cleaning with immersion disinfection... 27 4.9.2 Manual cleaning with ultrasound and immersion disinfection 28 4.10 Mechanical cleaning/disinfecting... 29 4.10.1 Mechanical alkaline cleaning and thermal disinfecting... 29 4.11 Mechanical cleaning/disinfection with manual pre-cleaning . 30 4.11.1 Manual pre-cleaning with a brush... 30 4.11.2 Manual pre-cleaning with ultrasound and brush... 31 4.11.3 Mechanical alkaline cleaning and thermal disinfecting... 31 4.12 Inspection... 32 4.12.1 Visual inspection... 32 4.12.2 Function test... 32

4.13 4.13.1 4.13.2 4.13.3 4.13.4 4.13.5 4.13.6 4.13.7 4.14 4.15 4.16 5. 5.1 5.2 6. 7.

Assembling... Downtube SZ378R/SZ405R... Screwdriver SZ381R... Rod length measuring instrument for short construction SZ382R... Rod inserter for short construction SZ384R... Rod inserter for long construction SZ385R... Alignment working port SZ398P... Alignment tool SZ399R... Packaging... Steam sterilization... Storage... Maintenance and Service... Technical Service... Accessories/Spare parts... Disposal... Symbols on product and packaging...

1.

About this document

32 32 32 32 32 33 33 33 33 33 33 33 33 33 33 33

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 extremely severe injuries may result. WARNING Indicates a potential danger. If it is not prevented, minor or moderate injuries may result. CAUTION Indicates a potential damage to property. If these are not prevented, the product may be damaged.

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en 2.

Clinical application

2.1

Areas of application and restrictions on use

2.1.1 Intended purpose 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 of Ennovate implants TA014887.

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.

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

BB540

Carbon steel scalpel blades

SR138SU

Ennovate injection cannula MIS

SZ364SU

Ennovate MIS bone access needle

SZ369SU

Ennovate MIS K-wire SS, sterile

SZ370SU

Ennovate MIS K-wire nitinol, sterile

The product has been sterilized using irradiation or ethylene oxide and is 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

BB540

Carbon steel scalpel blades

SR138SU

Ennovate injection cannula MIS

SZ364SU

Ennovate MIS bone access needle

SZ369SU

Ennovate MIS K-wire SS, sterile

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.

SZ369S

Ennovate MIS K-wire SS, unsterile

SZ370SU

Ennovate MIS K-wire nitinol, sterile

SZ370

Ennovate MIS K-wire nitinol, unsterile

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.

► Do not reuse product.

2.2.2

Product

Product specific safety information ► See usage instructions 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.

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en 3.

Safe operation

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. While doing so, ensure 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 forceps. ► 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. 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 check prior to using the product.

3.1

Place K-wire

3.1.1

Place K-wire with bone access needle SZ364SU

a

4

Fig. 1 ► Read and observe the enclosed instructions for use of the aspiration

needle SZ364SU. ► Determine entry point and alignment of the pedicle screws. ► Perforate cortex with bone access needle 4. ► Insert the bone access needle 4 under radiographic control to the desired depth. ► Rotate top part a of the bone access needle 4 clockwise by 90° and remove from the sleeve b.

10 10

CAUTION Instrument can fall in situ or on the floor! Loosening of the handle during application! ► Inspect the seating of the coupling handles on the instruments.

9

8

b

Note All actuation 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 using the specialized instruments for the Ennovate system, and without the use of a rod or a locking screw. Then the polyaxial screw temporarily behaves like 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.

b

b

9

b

Fig. 2 ► Insert K-wire 10 in sleeve b of the bone access needle 4 and insert to

the desired depth with K-wire forceps 8 and slotted hammer 9 under radiographic control. ► After reaching the desired depth: Remove the sleeve b for the aspiration needle 4 . Use slotted hammer 9 if necessary. In doing so, ensure that the position of the K-wire 10 does not change.

Note PolyLock® does not necessarily have to be loosened before the final interlocking of the polyaxial screw using the rod and locking screw.

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en 3.1.2

Place K-wire with K-wire targeting device (SZ365R and SZ366R) ► Determine entry point and alignment of the pedicle screws. 6 a b

7

7

► Insert K-wire 10 through K-wire sleeve 7 and insert to the desired

depth with K-wire forceps 8 and slotted hammer 9 under radiographic control. When doing so, ensure that the K-wire is clamped in the recesses c on the mouth part of the K-wire forceps 8. ► After reaching the desired depth: remove K- wire sleeve 7 using K-wire pliers 8 and slotted hammer 9. – In doing so, ensure that the position of the K-wire 10 does not change. – To do so, position K-wire pliers 8 using the provided ledge d behind the articulation on the provided square e on the K-wire sleeve 7 beneath the fastening thread and clamp by actuating the handle parts. ► Place slotted hammer 9 on the clamped K-wire forceps 8, knock out Kwire sleeve 7 and remove over the K-wire 10.

3.2

Perform skin incision with skin incision guide SZ371R 10

Fig. 3 ► Push K-wire trocar 6 in K-wire sleeve 7 from above up to the stop and

screw completely together clockwise using the gold colored sleeve a. Ensure that the trocar and sleeve are securely connected with the gold colored sleeve a. Together, the K-wire trocar 6 and K-wire sleeve 7 from the K-wire targeting device.

11 a

11

DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! ► Insert K-wire targeting device max. 30 mm deep. ► Perforate cortex with K-wire targeting device. ► Insert the K-wire targeting device under radiographic control to the

Fig. 5

desired depth. Note In order that the hand does not enter the beam path when holding the targeting device, the PEEK rod b can be mounted on the trocar and the trocar held at a certain distance from the beam path.

WARNING Risk of injury due to use of unsuitable scalpel blades! ► Mount only scalpel blades BB540 on the skin incision guide.

► Completely loosen the gold colored sleeve a on the K-wire trocar 6.

► Make skin incision matched to the diameter of the downtube: guide

While doing so, brace on the handle of the K-wire trocar 6. ► Remove K-wire trocar 6 from trocar sleeve 7. Use slotted hammer 9 if necessary.

skin incision guide 11 over K-wire 10 and make skin incision. When doing so, ensure the correct depth of the skin incision. ► Remove skin incision guide 11 over K-wire 10.

9

9

10

8

7

8

► Mount two scalpel blades BB540 a on the skin incision guide 11.

10

3.3

8

Fasciae and muscles are bluntly dilated to expand access for inserting the screws. 15 10

7

d

Perform dilation with dilator SZ372T to SZ374T and dilator handle SZ375T

e 14 13 12

c

Fig. 4

Fig. 6 6

a

b 15

c

en ► Push dilators 12 to 14 successively over the K-wire 10. While doing so,

ensure that the K-wire is always held in its position. ► Place dilators directly on the bone in order to prevent soft tissue irritations. Note The dilator handle 15 can be optionally used to facilitate the insertion of the dilators. To do so, the dilators 12 to 14 are inserted into the corresponding opening a to c of the dilator handle 15.

3.4

Enlarge pedicle canal with pedicle probe SZ376R

If necessary, the pedicle canal can be opened further with the pedicle probe. WARNING Revision required in case of screw loosening or pedicle break! ► Use pedicle probe only for screws with ∅ 5.5 mm and larger. ► Do not use pedicle probe deeper than 80 mm. Coordinate use to determined screw length. ► Carefully insert the pedicle preparator. Avoid levering and bending during insertion. ► Carefully insert the pedicle preparator. Avoid levering and bending during insertion Note The pedicle probe is either guided through the medium dilator 13 or the large dilator 14 or used without dilators.

3.5

Cut thread with screw tap 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. a

10

► Remove dilators 12 (and 13 and 14 as applicable) over the K-wire, see

Fig. 6. 10

10

16

16

b

a

3 c

13/14

3

Fig. 8 Fig. 7

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

of the corresponding screw tap 3 up to the stop.

► Guide pedicle probe 16 over the K-wire 10 and prepare to required

► Set rotation direction setting on the handle to “IN”.

depth. When using dilators, ensure that pedicle probe into the dilator 13/14. ► Remove pedicle probe 16 from the site.

► Guide screw tap 3 over the K-wire 10 and cut threads to required

depth by rotating clockwise. ► Set rotation direction setting on the handle to “OUT”. ► Unscrew screw tap 3 counter-clockwise and remove over the K-

wire 10. ► Loosen screw tap 3 from the handle a. To do so, push back the black sleeve b on the handle and remove screw tap 3.

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en 3.6

Determine screw length with screw length measuring device SZ377R

Note The displayed screw length is approx. 2 mm shorter than the K-wire in the screw length measuring device. This increases the security that the screw cannot be screwed in further than the K-wire, injuring underlying structures. The readout is only an approximate value, which is dependent on the insertion depth of the K-wire. The final selection of screw length must be made by the operator. ► Make sure that the position of the K-wire 10 approximately corre-

sponds with the final screw depth. 10

► Pull gold color sleeve a of the downtube 18 back against the spring

mechanism up to the stop so that the retaining lugs b are visible. ► Push the downtube 18 with the retaining lugs b into the interface c on the screw head of the pedicle screw d in this position until an acoustic signal can be heard. This signals the latching of the downtube into the screw head. ► Visually inspect the connection between the downtube 18 and the pedicle screw d. ► Release the gold colored sleeve a. The downtube 18 is moved forward over the pedicle screw d via the spring mechanism. ► Fasten pedicle screw d to the downtube: tighten gold colored sleeve a counter-clockwise (left-hand thread) to the stop and simultaneously hold the downtube 18 securely against it. Fastening is complete when the marking (line and lock) is visible. Note If necessary, the locking wrench for downtube 19 can be pushed over the downtube in order to additionally tighten the connection and secure it against loosening.

17 a

3.8

Screw in pedicle screw

17

Fig. 9 ► Guide screw length measuring device 17 over the K-wire 10 until it lies

on the vertebral body. When doing so, ensure the correct orientation of the screw length measuring device. ► Read screw length between the two widest markings a on the Kwire 10.

3.7

Couple downtube SZ378R/SZ405R to pedicle screw

CAUTION Operation delay! Damage to the pedicle screw, the set screw and the downtube from loosening of the screw interlock from the downtube! ► Check that the pedicle screw is solidly fastened. ► Visually inspect correct seating of the support arms in the screw head. ► Tighten gold colored sleeve on downtube only by hand or with locking wrench. Do not use additional any additional tools.

18 a

b

c

d

18 a 19

Fig. 10 8

d

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. While doing so, ensure 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. 3.8.1 Screw in pedicle screw with screwdriver SZ381R To screw in the Ennovate pedicle screw, it is connected with the screwdriver. To do so, the pedicle screw must already be fastened completely in the downtube. CAUTION Operation delay! Damage to the pedicle screw, the set screw and by loosening the screwdriver from the screw! Torque cannot be transferred! ► Completely connect the screwdriver with the screw so that the marking line on the screwdriver terminates with the end of the downtube. ► Check that the pedicle screw is securely fastened to the screwdriver. ► Verify the axial alignment of the pedicle screw to the screwdriver. ► Do not hold the gold colored sleeve of the screwdriver when screwing in the pedicle screw. Hold the downtube for guidance.

en ► Remove handle f by actuating the black sleeve on the handle of the

21 c

10 f

21

18

e

d

a

b

Fig. 11

screwdriver 21. ► Verify position and size of the pedicle screw before placing the rod with intraoperative imaging. 3.8.2

Screw in fenestrated pedicle screw with injection cannula SR138SU and cannula sleeve SR139R and fix with bone cement For the following steps, the fenestrated Ennovate pedicle screw must already be completely fixed in the downtube. The injection cannula and the cannula sleeve are used to screw in the fenestrated pedicle screw, instead of the screwdriver. These are first connected to each other. To increase anchoring stability, the fenestrated Ennovate pedicle screw can be fixed with bone cement. WARNING Risk of injury due to material incompatibility! ► Only use application systems that have been approved for use with bone cement. Screw in fenestrated pedicle screw

► Insert screwdriver 21 into the downtube 18 until the tip a of the

screwdriver is located in the inner profile of the screw head b and thus axially aligned to the screw shaft. ► Turn the screwdriver 21 into the thread of the screw body by rotating the gold colored sleeve c of the screwdriver clockwise. Securely hold the gold colored sleeve d of the downtube 18 while doing so. Fastening is complete when the marking line e on the screwdriver 21 terminates with the end of the downtube 18 and the polyaxial alignment of the screw (when using polyaxial screws) is completely blocked. ► Push preferred handle f (SZ222R to SZ225R) onto the hex connection of the screwdriver 21 up to the stop. ► Set rotation direction setting on the handle to “IN”. ► Carefully guide the connected instruments over the K-wire 10 and screw in pedicle screw by rotating clockwise several rotations under radiographic control. Do not hold the screwdriver 21 by the gold colored sleeve c while doing so, as otherwise the screwdriver will release from the screw. ► Once the pedicle screw has sufficient hold in the bone, remove Kwire 10 to prevent further advancing of the K-wire. The K-wire cutter 8 can be used together with the slotted hammer 9 for this purpose. ► Insert the pedicle screw under radiographic control up to the desired depth. – 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. – When using monoaxial screws, ensure that the downtubes are aligned to each other so that the other instrumentation steps can be carried out. CAUTION Operation delay! Damage to the pedicle screw, the set screw and the downtube and from loosening of the screw interlock from the downtube! ► When loosening the screwdriver, do not hold the gold colored sleeve of the downtube, or do not release the gold colored sleeve of the downtube. ► After removing the screwdriver, verify solid fastening of the pedicle screw with the downtube and tighten as applicable.

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 cannula sleeve 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. 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! Torque cannot be transferred! ► Completely connect the injection cannula and cannula sleeve to the pedicle screw so that the marking line on the cannula sleeve terminates with the end of the downtube. ► Check that the pedicle screw is solidly fastened to the injection cannula. ► Verify the axial alignment of the pedicle screw to the injection cannula. ► Do not hold the gold colored sleeve for the injection cannula when screwing in the pedicle screw. Hold the downtube for guidance.

► Release screwdriver 21 from the downtube 18: release screwdriver 21

from the pedicle screw by turning the gold colored sleeve c counterclockwise and remove from the downtube 18. 9

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.

38

38

38 a b

39

39

39 c 18

► Carefully guide the connected instruments over the K-wire 18/38/39

and screw in pedicle screw by rotating clockwise several rotations under radiographic control. When doing so, do not hold the sleeve for the injection cannula 39, as otherwise the sleeve and injection cannula 38 will release from the pedicle screw. ► Once the pedicle screw has sufficient hold in the bone, remove Kwire 10 to prevent further advancing of the K-wire. The K-wire cutter 8 can be used together with the slotted hammer 9 for this purpose. ► Insert the pedicle screw under radiographic control up to the desired depth. – 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. – When using monoaxial screws, ensure that the downtubes are aligned to each other so that the other instrumentation steps can be carried out. ► Remove the handle d by retracting the black sleeve e of the injection cannula 38.

Fig. 12

CAUTION Damage to the pedicle screw, the set screw and the downtube and operation delay from loosening of the screw interlock from the downtube! ► When loosening the sleeve for the injection cannula, do not hold the gold colored sleeve of the downtube, or do not release the gold colored sleeve of the downtube. ► After removing the injection cannula, verify solid fastening of the pedicle screw with the downtube and tighten as applicable.

► Connect injection cannula 38 to cannula sleeve 39: insert injection

Cement fenestrated pedicle screw

cannula 38 at a slight incline through the tip of the cannula sleeve 39 and pivot into the sleeve at the recessed location. ► Insert connected instrument into the downtube 18 until the tip of the injection cannula 38 sits in the inner profile of the screw head and is thus axially aligned to the screw shaft. ► Screw in cannula sleeve 39 into the thread of the screw body by rotating the gold colored sleeve a clockwise. Securely hold the gold colored sleeve c of the downtube 18 while doing so. Fastening is complete when the marking line b on the cannula sleeve 39 terminates with the end of the downtube 18 and the polyaxial alignment of the screw (when using polyaxial screws) is completely blocked. 10 d

e 18/38/39

WARNING Revision and loss of anchoring stability by alignment (axial twisting) of the downtube after cementing! ► Align rod slots/rod grooves of the downtube before cementing the pedicle screw. 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. CAUTION Operation delay! Uncontrolled escape of cement on Luer connection! ► Ensure that the Luer lock adapter screw is fully screwed in on the injection cannula. CAUTION Inadequate fixation during 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.

Fig. 13 ► Push preferred handle d (SZ222R to SZ225R) onto the hex connection

of the injection cannula 38 up to the stop. ► Set rotation direction setting on the handle to “IN”.

10

Note Cementing takes place after all the screws have been aligned and the connection rods have been adapted (see Chapter 3.9), but before inserting the rods (see Chapter 3.12) and before locking the fenestrated pedicle screw.

en ► Screw the Luer lock adapter f completely on the injection cannula 38. ► Check that the pedicle screw is solidly fastened to the injection

cannula 38. ► Verify the position of the pedicle screw by a radiographic process. ► Prepare the cement. Follow the usage instructions for the cement and

applicator used. ► Cement pedicle screw only with a cement suitable for screw augmen-

tation. Note The dead space volume of the injection cannula equals 0.8 ml. ► Screw applicator into the Luer connection of the injection cannula 38

from above. Ensure that the connection is secure. ► Regularly verify with radiographic process during application of the bone cement. ► Carefully actuate applicator and apply cement under low pressure. Ensure the axial alignment of the applicator to the injection cannula 38. Avoid levering and inclined placement. ► Apply cement until it escapes from the lateral slots of the pedicle screw. Avoid uncontrolled cement escape by continually observing under radiographic control.

WARNING Screwing in or unscrewing of monoaxial screw by alignment (axial twisting) of the downtube! ► Align rod slots/rod grooves on the downtube under radiographic control. CAUTION Rod length cannot be determined! ► Align downtubes parallel to each other for measurement of the rod length with the rod length caliper. When using monoaxial screws, the downtubes cannot be subsequently aligned parallel. ► Take any subsequent distraction into account when determining the

rod length. 22 22 a b b

38

f

18

a c 18

18

18

g

Fig. 15 ► Guide rod length caliper 22 with both hollow cylinders a over both

Fig. 14 ► Continue to apply cement until a cement plume is visible. If necessary,

press the remaining cement in the cannula with the plunger g. To do so, push plunger g into the injection cannula 38 from the top and press down. ► Cement additional pedicle screws with the same procedure. ► Before removing the injection cannula 38: allow the cement to cure completely. ► After the cement cures completely: remove injection cannula 38 and cannula sleeve 39 from the downtube 18. To do so, release cannula sleeve 39 from the pedicle screw by turning the gold colored sleeve a counter-clockwise and remove from the downtube 18, see Fig. 12.

3.9

Determine rod length with rod length caliper SZ382R

The necessary rod length is determined with the rod length caliper SZ382R. Note The determination of rod length is only an estimate. The final selection of rod length must be made by the operator. WARNING Screw in or unscrew polyaxial screw by alignment (axial twisting) of the clamp sleeve after activation of PolyLock®! ► Do not axially twist clamp sleeve if the PolyLock® is activated. ► Align rod slots/rod grooves for the clamp sleeve before activating the PolyLock®.

outer downtubes 18 (cranial and caudal downtube). Ensure that both downtubes are aligned parallel to each other. ► Read the rod length through the window b in the slide unit. Note The length indicated on the scale indicates the actual rod length. If the measured rod length is between two existing lengths, the two closest rod lengths are indicated by small arrows in the window b. The operator has to select the rod length. Insertion tip and rod hex are already considered in the rod length specification. ► Remove rod length caliper 22 from the downtubes 18. ► Align downtubes 18 with the grooves in the rod direction. To do so, set

rod length caliper 22 inclined by 90° in recesses c of the downtubes 18.

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

the proper length.

3.11 Bend rod with french rod bender SZ270R If necessary, the rod can be bent with the french rod bender SZ270R. Three different bending radiuses can be set on the french rod bender. Note Alternatively, the french rod bender FW024R can also be used with titanium rods.

11

en WARNING Danger of injury from damage (breakage) of the rod if bent incorrectly! Rod cannot be inserted into the downtube! Rod cannot be fastened! ► Avoid severe rod bending in the region of the pedicle screw. ► Only bend rod with provided french rod bender. ► Do not bend rod multiple times at the same location. ► Do not bend rod back

b d c 5 c

CAUTION Operation delay due to incomplete coupling of the rod on the rod inserter or incorrect alignment of the rod slot/rod grooves of the downtube! ► Insert rod up to the stop in the rod inserter and completely tighten fixation. ► Verify solid fixation of the rod in the rod inserter. ► Only tighten/loosen gold colored rotary knob on the rod inserter by hand. Do not use additional any additional tools. ► Align rod slots/rod grooves of the downtube before insertion of the rod. Note The MIS rods have a conical tip on one side for easier implantation through the soft tissue. On the opposite side of the rod, there is a hex that forms the solid interface to the rod inserter. Note When using the long rod inserter SZ385R, an additional distal incision can be required.

a 23

a

23

Fig. 16

a

► Adjust desired bending radius on french rod bender 5: pull rotary

a

knob a and set the desired radius by rotating. ► 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 ► Bend rod b to the desired radius by actuating the handle d of the

18

c

b

french rod bender 5.

b

b

3.12 Insert rod with rod inserter SZ384R/SZ385R WARNING Loss of the rod in situ or expansion of the skin incision required! ► Do not decouple rod inserter from the rod until the rod is completely fastened by at least one set screw.

Fig. 17

a a

WARNING Revision required due to faulty fastening of the rod! ► Always place hex and point of the rod outside of the screw head. ► 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.

24 24

c b

Fig. 18

12

18 b

b

en ► Open the mouth part of the rod inserter 23/24 by turning the gold col-

ored rotary knob a counter-clockwise (up to the line mark with SZ384R). ► Insert rod b with the hex into the mouth part c of the rod inserter 23/24 up to the stop.

3.14 Push rod into screw head 3.14.1 Push rod into screw head with quick rod pusher SZ397R (option 1) Once the rod has been placed through all downtubes, the rod can be pressed into the screw head with the quick rod pusher.

Note The rod can be aligned to the instrument with the orientation lines on the rod and on the rod inserter. ► Rotate the gold colored rotary knob a clockwise and tighten. Verify

solid fixation of the rod in the rod inserter and tighten if necessary. ► Guide the clamped rod b with the rod inserter 23/24 through the lon-

35

gitudinal slot of the downtube 18.

18 18

► Do not decouple rod inserter 23/24 from the rod until the rod b is com-

35

35

pletely fastened by at least one set screw, see Chapter 3.15.

3.13 Verify rod with rod indicator SZ387R The rod indicator SZ387R is used in order to ensure that the rod was placed correctly by the downtubes. CAUTION Faulty display of the rod indicator due to tissue or instrument within the downtube! ► Before inserting the rod indicator, ensure that no tissue is present in the downtube and that no other instruments are located in the downtube.

a

25 18

a

25

18

a

b

a

Fig. 20 ► Insert quick rod pusher 35 from the top into the downtube 18.

Note The quick rod pusher can be pushed into the downtube in two positions, so that the handle points in the direction of the rod axis to the right or left of the downtube. WARNING Operation delay! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Push quick rod pusher down completely until the line marking terminates flush with the head of the downtube. ► If the pressure force by hand is insufficient: use rod pusher SZ389R. ► Push rod a into the screw head: push quick rod pusher 35 down on the

Fig. 19 ► Insert rod indicator 25 from the top into the downtube 18. Ensure that

the rod indicator 25 lies flush with the large diameter on the head of the downtube. ► Read rod position on the window a of the rod indicator 25. – If the “rod” label is visible, the rod was placed correctly. If the “no rod” label is visible, the rod is not in the downtube. ► If the rod is not located in the downtube: correct position of the rod. To do so, remove rod indicator 25 from the downtube and insert rod again, see Chapter 3.12.

handle until the line marking b terminates flush with the head of the downtube 18. Rod a is located completely in the screw head. ► Continue, see Chapter 3.15. 3.14.2 Push rod into screw head with rod pusher SZ389R (option 2) Once the rod has been positioned through all clamp sleeves, the rod can be pressed into the screw head using the rod pusher. DANGER Risk of severe injury! Pedicle screw can tear out of the spinal column if too much force is applied when pushing the rod! ► Make sure that no excessive force is applied when turning the gold-colored sleeve for the rod pusher to the marking "0". When the marking "0" is reached, the forces are no longer transmitted to the screw, but rather converted into the locking mechanism of the polyaxialilty (PolyLock®).

13

en CAUTION Operation delay! Set screw cannot be screwed into screw head! Rod cannot be fixated! ► Turn rod pusher all the way down until the "0" marking on the gold-colored sleeve of the rod persuader instrument terminates flush with the head of the clamp sleeve. Note The rod pusher handle 28 can be used for easier rotation.

a 27 28

18

18

b

b

30

c

Fig. 21 ► Guide rod pusher 27 from the top into the downtube 18 and turn

golden sleeve a of the rod pusher by hand or with rod pusher handle 28 into the downtube 18 clockwise. Rod b is pushed down. The scale c on the rod pusher indicates the remaining reduction path.

3.15 Insert and tighten set screw with the insertion instrument for the set screw SZ391R 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®. ► Hold brace in position and do not twist against the downtube or the inserted rod. CAUTION Operation delay! Damage to the implant and/or instruments! ► Do not allow set screw driver to fall into the downtube. ► Receive set screw correctly and completely up to the line marking with the insertion instrument for the set screw. ► Insert set screw driver axially in the rod pusher. Ensure that the insertion instrument for the set screw does not tilt. 3.15.1 Take up set screw

Note The counter torque handle can be placed on the downtube in eight different positions. a

29

► If the forces are high when screwing in, use counter torque handle 30:

a

push counter torque handle 30 from the top on the head of the downtube 18 up to the stop. Hold the bracing handle 30 securely in position while screwing in. The rod b is completely in the screw head when the scale on the rod pusher reaches the "0" marking. ► Repeat procedure for additional pedicle screws. Rod b is located completely in the screw head. ► Continue, see Chapter 3.15.

d

29

b c 29

d c c

Fig. 22 ► Push torque wrench handle SZ228R a onto the hex connection b of the

insertion instrument for the set screw 29 up to the stop. ► Completely take up set screw SY001T/SY001TS c with the insertion instrument for the set screw 29. To do so, insert the working end of the insertion instrument for the set screw 29 into the socket of the set screw c and push with light pressure until the line marking d terminates flush with the surface of the set screw c. ► Verify secure seat of the locking screw c on the insertion instrument for the locking screw 29.

14

en 3.15.2 Insert and tighten set screw with MIS quick rod pusher SZ397R (option 1)

a

23/24

29 35

c

► Screw in the set screw by turning the torque wrench handle SZ228R a

clockwise. Hold the counter torque handle 30 securely in position while screwing in until the acoustic signal of the triggering counter torque handle 30 sounds. The acoustic signal indicates that 10 Nm has been reached. ► Remove set screw driver 29 from the rod pusher 27. ► Repeat procedure for additional screws. ► Remove rod pusher 27 from the downtube 18 by turning the gold colored sleeve b counter-clockwise. ► Decouple rod inserter 23/24 from the rod d by turning the golden rotary knob c counter-clockwise and remove.

3.16 Remove downtube SZ378R/SZ405R with removal key SZ380R

b

WARNING Operation delay! Downtube cannot be removed! ► Loosen gold colored sleeve of the downtube one to two clockwise rotations before inserting the removal key.

d

Fig. 23 ► Insert set screw driver 29 with mounted set screw into the cannuliza-

tion of the quick rod pusher 35 and carefully guide down onto the screw head. ► Screw in the set screw by turning the torque wrench handle SZ228R a clockwise. Hold the handle of the quick rod pusher 35 securely in position while screwing in until the acoustic signal of the triggering torque wrench handle sounds. The acoustic signal indicates that 10 Nm has been reached. ► Remove set screw driver 29 from the quick rod pusher 35. ► Repeat procedure for additional screws. ► Decouple rod inserter 23/24 from the rod d by turning the golden rotary knob c counter-clockwise and remove. 3.15.3 Insert and tighten set screw with rod pusher SZ389R (option 2) Note The counter torque handle can be placed on the downtube in eight different positions.

► Ensure that all instruments have been removed from the downtube 18.

20 20

90°

20

b

a 18

18

Fig. 25 a

► Loosen gold colored sleeve a on downtube 18 one to two clockwise

23/24 c

revolutions until the line marking is no longer visible.

29 27

30

30

27/b 18

18

Note If necessary, the locking wrench for downtube 19 can be used to make loosening easier. ► Insert removal key 20 from the top into the downtube 18 up to the

d

stop so that the line marking b terminates flush with the head of the downtube 18. ► Turn removal key 20clockwise by 90° towards the clamp sleeve and remove from site in conjunction with the clamp sleeve 18 by pulling on the removal key 20. ► Repeat procedure for additional downtubes.

Fig. 24 ► Push counter torque handle 30 from the top on the head of the

downtube 18 up to the stop. ► Insert set screw driver 29 with mounted set screw into the cannuliza-

tion of the rod pusher 27 and carefully guide down onto the screw head. 15

en 3.17 Carry out corrective measure (optional) 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 forceps or on the parallel compressor forceps and to the downtube. WARNING Injury to patient from initiation of high torques on the spinal column! ► When tightening the locking screw and when activating the PolyLock®, counteract any movement by tightly gripping the parallel distractor handle or the parallel compressor handle. ► Hold the handles of the parallel distractor forceps or parallel compressor forceps in position and do not twist against the downtube or the inserted rod. CAUTION Screw in or unscrew polyaxial screw by alignment (axial twisting) of the clamp sleeve after activation of PolyLock®! ► Do not axially twist clamp sleeve if the PolyLock® is activated. ► Always align rod slots/rod grooves of the clamp sleeve before PolyLock® is activated. 3.17.1 Prepare distraction/compression If necessary, the distraction or compression can be performed with the parallel distractor forceps 1 or with the parallel compressor forceps 2 and the parallel sleeve 26 or C-ring attachments for the compression/distraction device 33. Alternatively, the french rod bender compression/distraction device 32 can also be used for distraction. ► Perform operation steps up to pushing the rod, see Chapter 3.14. ► Select starting point of distraction/compression.

3.17.2 Perform parallel distraction/compression with parallel distractor forceps SZ231R and parallel compressor forceps SZ232R (option 1) Note Only straight rods can be used for the parallel distraction/compression. 26/33

26/33

1/2 18

18

Fig. 27 ► Guide parallel sleeves 26 or C-rings for compression/distraction

device 33 over heads of the downtubes 18 that are to be distracted/compressed. Ensure correct alignment with parallel sleeves 26 when doing so ("UP" text points up). ► Couple parallel distractor forceps 1 or parallel compressor forceps 2 to parallel sleeves 26 or C-rings for compression/distraction device 33.

a 26/33

31 27

a 29 1/2

27

26/33

18 b c

27

Fig. 28 ► For polyaxial screws: Activate PolyLock®:

29 18

27 30 18

Fig. 26 ► Ensure that the rod pusher 27 is completely inserted into the down-

tube. ► Completely tighten set screw, see Chapter 3.15.3.

The set screw is used as an anchor point for the distraction/compression. ► Loosen or leave loose adjacent set screw in order to be able to start the distraction/compression process. Ensure that the downtubes 18 are aligned parallel to each other. 16

– Slide torque handle SZ228R a all the way onto the hex connection of the PolyBlocker 31. – Set torque handle ST228R a including mounted PolyBlocker 31 from above into the gold colored sleeve of the rod pusher 27 and turn the torque handle SZ228R a clockwise until the acoustic signal of the triggering torque handle is heard. Counteract any movement by tightly gripping the parallel distractor handle 1 or the parallel compressor handle 2. The acoustic signal indicates that the PolyLock® was activated. – Remove torque handle SZ228R a including mounted PolyBlocker 31 from the rod pusher 27. ► Perform distraction/compression: push handle parts of the parallel distractor forceps 1 or parallel compressor forceps 2 together. ► Secure distraction/compression with gold colored nut b on the parallel distractor forceps 1 or parallel compressor forceps 2. ► Push torque wrench handle SZ228R a onto the hex connection of the insertion instrument for the set screw 29 up to the stop.

en ► Guide insertion instrument for the set screw 29 through the cannuli-

zation of the rod pusher 27 under light pressure completely into the socket of the previously loosened set screw until the line marking terminates flush with the surface. ► Check for secure seating of the insertion instrument for the set screw 29, see Chapter 3.15.1. ► Turn torque wrench handle SZ228R a clockwise until the acoustic signal of the triggering torque wrench handle sounds. Counter-hold parallel distractor forceps 1 or parallel compressor forceps 2 securely on the handles. The acoustic signal indicates that 10 Nm has been reached. ► Relieve parallel distractor forceps 1 or parallel compressor forceps 2 by loosening the gold colored nut b and opening up the locking device c. ► Retighten both set screws as described above, while bracing with torque wrench handle SZ228R a. ► For polyaxial screws: Deactivate PolyLock®: – Slide torque handle SZ228R a all the way onto the hex connection of the PolyBlocker 31. – Insert torque handle SZ228R a with mounted PolyBlocker 31 from the top into the gold colored sleeve of the rod pusher 27 and turn the torque handle SZ228R a counter-clockwise until the rod persuader instrument 27 can be unscrewed without significant resistance. Counteract any movement by tightly gripping the parallel distractor handle 1 or the parallel compressor handle 2. – Remove torque handle SZ228R a including the mounted PolyBlocker 31 from the rod pusher 27. ► Loosen rod pusher 27 by turning the gold colored sleeve clockwise and pulling out of the downtube 18. ► Remove parallel distractor forceps 1 or parallel compressor forceps 2 from the downtubes 18. ► If needed, use the process for 3.17.3 Perform distraction with compression/distraction device SZ394T (option 2)

27 33 18

a 31 27 33 18

2

Fig. 29 ► Guide C-rings for compression/distraction device 33 over heads of the

downtubes 18 that are to be distracted/compressed. ► Couple parallel compressor forceps 2 to C-rings for compression/dis-

traction device 33.

a 29 27 33 18

2

18

32

32

b

c

Fig. 30 ► For polyaxial screws: ActivatePolyLock®:

– Slide torque handle SZ228R a all the way onto the hex connection of the PolyBlocker 31. – Insert torque handle SZ228R a including mounted PolyBlocker 31 from above into the gold colored sleeve of the rod pusher 27 and turn the torque handle SZ228R a clockwise until the acoustic signal of the triggering torque handle is heard. Counteract any movement by tightly gripping the handles of the parallel distractor 2 in doing so. The acoustic signal indicates that the PolyLock® was activated. – Remove torque handle SZ228R a including mounted PolyBlocker 31 from the rod pusher 27. ► Place compression/distraction device 32 between the two downtubes 18 and rotate 90° to form the rotation point. When doing this, ensure that the compression/distraction device 32 is placed as close to the body as possible. ► Perform distraction: push handle parts of the parallel compressor forceps 2 together. ► Secure distraction/compression with gold colored nut b on the parallel compressor forceps 2. ► Push torque wrench handle SZ228R a onto the hex connection of the insertion instrument for the set screw 29 up to the stop. ► Guide insertion instrument for the set screw 29 through the cannulization of the rod pusher 27 under light pressure completely into the socket of the previously loosened set screw until the line marking terminates flush with the surface. ► Check for secure seating of the insertion instrument for the set screw 29, see Chapter 3.15.1. ► Turn torque wrench handle SZ228R a clockwise until the acoustic signal of the triggering torque wrench handle sounds. Counter-hold parallel distractor forceps 2 securely on the handles when doing so. The acoustic signal indicates that 10 Nm has been reached. ► Relieve parallel compressor forceps 2 by loosening the gold colored nut b and opening up the locking device c. ► Remove compression/distraction device 32 between the two downtubes 18. ► Retighten both set screws as described above, while bracing with torque wrench handle SZ228R a.

17

en ► For polyaxial screws: Deactivate PolyLock®:

– Slide torque handle SZ228R a all the way onto the hex connection of the PolyBlocker 31. – Insert torque handle SZ228R a with mounted PolyBlocker 31 from the top into the gold colored sleeve of the rod pusher 27 and turn the torque handle SZ228R a counter-clockwise until the rod persuader instrument 27 can be unscrewed without significant resistance. Counteract any movement by tightly gripping the handles of the parallel distractor 2 in doing so. – Remove torque handle SZ228R a including the mounted PolyBlocker 31 from the rod pusher 27. ► Loosen rod pusher 27 by turning the gold colored sleeve clockwise and pulling out of the downtube 18. ► Remove parallel compressor forceps 2 from downtubes 18. ► If needed, activate the process for

3.18 Interbody fusion management: distraction/compression with alignment tool SZ399R and cage sleeve SZ396R (optional)

CAUTION Operation delay! Damage to the implant and downtube! ► Loosen gold colored sleeve of downtube one to two rotations clockwise before the outer sleeve of the alignment tool is twisted by 90° in order to loosen the downtube from the pedicle screw. CAUTION Operation delay! Damage to the implant and/or instruments! ► Do not allow alignment tool to fall into the downtube. ► Do not allow outer sleeve to fall over the hex shaft onto the implant. 3.18.1 Remove downtube SZ378R/SZ405R ► Perform operation steps up to screwing in the pedicle screw, see Chapter 3.8. a

b

In order to create more space in the case of a cage implantation, the downtubes can be temporarily removed from the pedicle screws and reattached later. Furthermore, the intervertebral disc space can be distracted for inserting the cage and compressed as required after insertion. The alignment tool 37 is used for this. WARNING Insufficient treatment or stabilization of the spinal column region to be treated! Damage to the implant and/or instruments! ► Never use alignment tool without inner rod. ► To activate the PolyLock® with the alignment instrument, completely connect the clamp sleeve to the pedicle screw and apply counter-action force. ► To activate PolyLock® with the alignment instrument, use only the 10 Nm torque handle SZ228R. WARNING Injury to patient from initiation of high torques on the spinal column! ► To activate the PolyLock® with the alignment instrument, completely connect clamp sleeve to the pedicle screw and apply counter-action force. ► Hold brace in position and do not twist against the downtube or the inserted rod. WARNING Screw in or unscrew polyaxial screw by twisting the alignment instrument in an axial direction after activation of PolyLock®! ► Do not axially twist alignment instrument with activated PolyLock® without bracing using the mounted clamp sleeve. 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 correct seating of the attachments on the parallel distractor forceps or on the parallel compressor forceps.

18

c

37

37 d 18

e

30 18

37

Fig. 31 ► Insert alignment instrument 37, consisting of outer sleeve a, hexago-

nal shaft b and inner rod c, completely mounted and correctly positioned, from above through the clamp sleeve 18 and set into the screw head. The directional arrow on the working end of the alignment tool 37 indicates the correct insertion direction. ► Screw in hexagonal end of the alignment tool 37 clockwise by hand into the screw head in order to anchor the instrument in the screw head. The instrument is fully screwed in when the upper marking line d on the outer sleeve a of the alignment tool 37 terminates flush with the end of the downtube 18. Note The counter torque handle can be placed in eight different positions. ► Push counter torque handle 30 from the top on the head of the

downtube 18 up to the stop. ► Push torque wrench handle SZ228R e onto the hex connection of the alignment tool 37 up to the stop. ► Align downtubes 18 parallel to each other. ► Tighten the alignment tool 37 by turning the torque wrench handle SZ228R e clockwise. Hold the counter torque handle 30 securely in position until the acoustic signal of the triggering torque wrench handle sounds. The acoustic signal indicates that 10 Nm have been reached and PolyLock® is activated.

en Note PolyLock® provides for the parallel distraction of the vertebral bodies in the following.

b 18

► To perform a compression: couple parallel compressor forceps 2 to

cage sleeve 34. ► Perform desired distraction/compression by pushing handle parts of parallel distractor forceps 1 or parallel compressor forceps 2 together. Note The distraction/compression can additionally be secured by the gold colored nut f on the parallel distractor forceps 1 or parallel compressor forceps 2. The cages can now be inserted in accordance with the corresponding cage surgery technology.

f

3.19 Recouple downtube after cage implantation a

90°

CAUTION Operation delay! Difficult coupling of the downtube! Damage to the instruments! ► Remove alignment working port before the downtube is completely engaged on the screw.

g

Fig. 32 ► Loosen gold colored sleeve f on downtube 18 one to two clockwise

revolutions until the line marking is no longer visible. Note If necessary, the locking wrench for downtube 19 can be used to make loosening easier. ► Pull outer sleeve a of the alignment tool 37 out of the downtube until

the circumferential line g on the outer sleeve terminates flush with the end of the downtube 18. ► Twist outer sleeve a of the alignment tool 37 90° to the downtube and remove the two instruments from the site together by pulling on the outer sleeve. ► Repeat the steps for adjacent downtube 18. The two hex shafts b of the alignment tool 37 are now parallel to each other in the two adjacent polyaxially locked pedicle screws. 3.18.2 Perform distraction/compression The distraction/compression can now be performed via the hex shafts of the alignment tool. f

CAUTION Operation delay due to faulty recoupling of downtube to the pedicle screw! Damage to the pedicle screw, the set screw and the downtube! ► Check that the pedicle screw is solidly fastened. ► Visually inspect correct seating of the support arms in the screw head. ► Axially pull or push downtube as applicable until correct seating of the downtube to the pedicle screw is attained. ► Tighten gold colored sleeve on downtube only by hand or with locking wrench. Do not use additional any additional tools. 3.19.1 Insert alignment working port SZ398P

b c b

a

36

36

b

34

1/2 34

Fig. 34 ► Push completely mounted alignment working port 36 over the hex

Fig. 33 ► Guide one cage sleeve 34 over the two hex shafts b of the alignment

tool 37. ► To perform a distraction: couple parallel distractor forceps 1 to cage

sleeve 34.

shaft b of the alignment tool 37 into the existing skin incision of the previously removed downtube 18. When doing so, ensure that the tissue is dilated far enough that there is free access to the pedicle screw. ► Guide the outer sleeve a of the alignment tool 37 over the fixed hex shaft b through the alignment working port 36 up to the stop on the pedicle screw. The correct position of the outer sleeve a has been reached when it sits on the pedicle screw, rotationally fixed, and the circumferential marking line c is visible on the hex shaft b. 19

en 3.19.2 Recouple downtube SZ378R/SZ405R with alignment tool SZ380R WARNING Operation delay! Damage or deformation of the K-wire! ► Axially align screw and downtube. ► Completely loosen gold colored sleeve d of the downtube 18 clockwise

(left-hand thread) so that it can be pulled back against the spring mechanism up to the stop. ► Release the gold colored sleeve d. ► Place downtube 18 from the top on the outer sleeve a of the alignment tool 37 and push down onto the pedicle screw.

► Push downtube 18 completely down on the pedicle screw and let it

click into place. The acoustic signal indicates that the downtube 18 has clicked into place in the screw head. The downtube is correctly latched in place when the upper marking line g on the outer sleeve of the alignment tool 37 terminates flush with the head of the downtube 18. ► If this is not the case, push or pull downtube 18 in the corresponding direction until the marking line terminates flush with the head of the downtube 18. ► Check support arms in screw head for correct seating. ► Fasten pedicle screw to the downtube: tighten gold colored sleeve d counter-clockwise (left-hand thread) to the stop. Securely hold the head of the downtube 18 while doing so. Fastening is complete when the marking h (line and lock) is visible. Note If necessary, the locking wrench for downtube 19 can be pushed over the downtube in order to additionally tighten the connection and secure it against loosening.

a e 18

18 d

Note The counter torque handle can be placed on the downtube in eight different positions.

f

► Push counter torque handle 30 from the top on the head of the

downtube 18 up to the stop. ► Push torque wrench handle SZ228R i onto the hex connection of the

alignment tool 37 up to the stop. ► Loosen the alignment tool 37 by turning the torque wrench

handle SZ228R i counter-clockwise. Hold the counter torque handle 30 securely in position until the alignment tool 37 can be unscrewed without significant resistance. Fig. 35 ► Open alignment working port 36 by loosening the gold colored

37

sleeve e. ► Remove gold colored sleeve e over the downtube 18. ► Individually remove remaining black half shells f of the alignment working port 36 from the site.

18

18

g i 37

d 18

Fig. 37

h 18

Fig. 36

20

30

► Remove all instruments from the downtube 18. ► Repeat the steps for adjacent downtube.