Ennovate Cervical Basic instruments

Ennovate Cervical Set Basic

1

11

17

2

3

12

18

4

5

14

13

19

6

20

7

8

15

21

9

10

16

22

23

24

Ennovate Cervical Set Complementary

1

18

50

57

43

51

58

44

45

52

59

60

46

53

61

31

47

54

62

55

63

48

49

65

66

56

64

en

Aesculap® Ennovate® Cervical Basic instruments Legend Ennovate Cervical Set Basic 1 Ennovate Cervical ratchet handle straight SZ001R 2 Ennovate Cervical drill handle tear drop style SZ002R 3 Ennovate Cervical drill handle palm style SZ003R 4 Ennovate Cervical torque limiting T-handle SZ005R 5 Ennovate Cervical torque limiting handle straight SZ006R 6 Ennovate Cervical counter torque handle SZ008R 7 Ennovate Cervical drill ∅ 2.3 mm solid for universal drill guide SZ016SU/SZ016R 8 Ennovate Cervical drill ∅ 2.8 mm solid for universal drill guide SZ017SU/SZ017R 9 Ennovate Cervical drill ∅ 2.3 mm for variable/fixed drill guide SZ019SU/SZ019R 10 Ennovate Cervical drill ∅ 2.8 mm for variable/fixed drill guide SZ020SU/SZ020R 11 Ennovate Cervical center punch SZ050R 12 Ennovate Cervical fixed drill guide, 12 mm SZ048R 13 Ennovate Cervical fixed drill guide, 14 mm SZ049R 14 Ennovate Cervical variable drill guide for 3.5 mm / 3.6 mm and 4.0 mm screws SZ054R 15 Ennovate Cervical universal drill guide OPEN/NAV (incl. 3.5 mm / 3.6 mm and 4.0 mm tube) SZ055R 16 Ennovate Cervical MIS universal drill guide (incl. 3.5 mm / 3.6 mm and 4.0 mm tube) SZ143R 17 Ennovate Cervical tube for universal drill guide ∅ 4.5 mm screws SZ058R 18 Ennovate Cervical screwdriver for polyaxial screws SZ063R 19 Ennovate Cervical ball end screwdriver for polyaxial screws SZ064R 20 Ennovate Cervical screw body manipulator SZ065R 21 Ennovate Cervical sounder SZ066R 22 Ennovate Cervical set screw starter double-ended SZ068R 23 Ennovate Cervical set screw starter single-ended SZ069R 24 Ennovate Cervical set screw torque/removal driver shaft SZ070R 25 Ennovate Cervical / S4 Cervical rod holding forceps FW076R 26 Ennovate Cervical rod bending template 150 mm SZ073SU 27 Ennovate Cervical rod cutter SZ075R 28 Ennovate Cervical rod cutter CoCr SZ077R 29 Ennovate Cervical rod bender SZ076R 30 Spinal rod bending forceps FW024R 31 Ennovate Cervical persuader in-line SZ080R 32 Ennovate Cervical K-wire ∅ 1.0 mm for 3.6 mm screws SZ010SU/SZ010R 33 Ennovate Cervical K-wire ∅ 1.5 mm for 4.0 mm and 4.5 mm screws SZ011SU/SZ011R 34 Ennovate Cervical / S4 Cervical pedicle depth gauge FW042R 35 Ennovate Cervical bone probe blunt straight SZ022R 36 Ennovate Cervical bone probe blunt curved SZ023R 37 Ennovate Cervical bone probe straight thoracic cannulated SZ024R 38 Ennovate Cervical obturator for can. bone probe SZ025R 39 Ennovate Cervical bone probe thoracic straight SZ026R

2

40 Ennovate Cervical bone probe thoracic curved SZ027R 41 Ennovate Cervical / S4 Cervical bone probe straight FW674R 42 Ennovate Cervical / S4 Cervical bone probe curved FW675R Ennovate Cervical Set Complementary 1 Ennovate Cervical ratchet handle straight SZ001R 18 Ennovate Cervical screwdriver for polyaxial screws SZ063R 43 Ennovate Cervical drill ∅ 3.3 mm solid for universal drill guide SZ018SU/SZ018R 44 Ennovate Cervical tap ∅ 3.5 mm / ∅ 3.6 mm SZ051R 45 Ennovate Cervical tap ∅ 4.0 mm SZ052R 46 Ennovate Cervical tap ∅ 4.5 mm SZ053R 31 Ennovate Cervical persuader in-line SZ080R 47 Ennovate Cervical rod persuader Basic SZ081R 48 Ennovate Cervical rod persuader pistol style SZ082R 49 Ennovate Cervical caliper for cross connectors SZ029R 50 Ennovate Cervical template for SQ020TS domino lateral 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm SZ030R 51 Ennovate Cervical template for SQ021TS domino lateral 3.5 mm / 4.0 mm to 5.5 mm SZ031R 52 Ennovate Cervical template for SQ022TS domino axial 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm SZ032R 53 Ennovate Cervical template for SQ023TS domino axial 3.5 mm / 4.0 mm to 5.5 mm SZ033R 54 Ennovate Cervical template for SQ024TS domino lateral 3.5 mm / 4.0 mm to 5.5 mm SZ034R 55 Ennovate Cervical template for SQ025TS domino lateral 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm SZ035R 56 Ennovate Cervical template for SQ010TS offset-connector SZ036R 57 Ennovate Cervical handle for connector templates SZ039R 58 Ennovate Cervical locking driver for head-to-head connector SZ089R 59 Ennovate Cervical rod bending template 60 mm SZ072SU 60 Ennovate Cervical rod bending template 290 mm SZ074SU 61 Ennovate Cervical in-situ rod bender SZ078R 62 Ennovate Cervical / S4 Cervical lamina preparator FW071R 63 Ennovate Cervical / S4 Cervical hook holding forceps curved FW528R 64 Ennovate Cervical / S4 Cervical compression forceps FW427R 65 Ennovate Cervical / S4 Cervical distraction forceps FW428R 66 Ennovate Cervical / S4 Cervical rod bending plates FW036R The relative size of the instruments does not necessarily reflect their size in reality. The depictions in this document are schematic representations only and may deviate from the actual product.

en Contents 1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 3. 3.1 3.2 3.3 3.3.1 3.3.2 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.11.1 3.11.2 3.12 3.12.1 3.12.2 3.12.3 3.13 3.14 3.15 3.15.1 3.15.2 3.15.3 3.16 3.17 3.18 3.18.1 3.18.2 3.18.3 3.19 3.20 3.20.1 3.20.2 3.20.3 3.20.4 3.20.5 3.21

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Safe application... Prepare screw hole with center punch 11 (SZ050R)... Drill holes for the Ennovate Cervical screws... Use variable drill guide 14 (SZ054R)... Use universal drill guide 15 (SZ055R)... Use bone probes... Confirm depth... Use K-wires as guidance for screw placement (optional)... Cut thread with tap (optional)... Insert screw... Align screw head... Select rod... Cut rod... Cut rod with rod cutter 27 (SZ075R)... Cut rod with rod cutter 28 (SZ077R)... Bend rod... Bend rod with spinal rod bending forceps 30 (FW024R)... Bend rod with Ennovate Cervical rod bender 29 (SZ076R) . . . Bend rod with rod bending plates 66 (FW036R) or in situ rod benders 61 (SZ078R)... Insert rod with rod holding forceps 25 (FW076R)... Insert set screw... Persuade rod... Use rod persuader in-line 31 (SZ080R)... Use rod persuader pistol style 48 (SZ082R)... Use rod persuader Basic 47 (SZ081R)... Tighten set screw... Remove Ennovate Cervical implants... Place laminar hook (optional technique)... Place laminar hook... Insert set screw... Tighten set screw... Perform compression and distraction (optional technique) . . . Use connectors... Cross connectors: Rod-to-rod connectors... Cross connectors: Head-to-head connectors... Domino connectors... Cable connectors... Lateral offset connectors (straight and L-shaped)... Use dual diameter rod SQ009TS...

4 4 4 4 4 4 4 4 4 4 5 5 7 7 7 7 8 9 10 11 11 11 12 14 14 14 14 14 15 15 15 16 16 17 17 17 18 19 19 21 21 21 21 21 21 22 23 23 24 25 25 26

3.22 3.22.1 3.22.2 3.22.3 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 4.7.7 4.7.8 4.7.9 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 4.13.4 4.13.5 4.13.6 4.13.7 4.13.8 4.13.9 4.14 4.15 4.16 5. 6.

Insert laminoplasty plate... 26 Prepare laminoplasty plate and hole... 26 Fix laminoplasty plate... 26 Insert rod... 27 Validated reprocessing procedure... 27 General safety instructions... 27 General information... 27 Single-use products... 28 Reusable products... 28 Preparations at the place of use... 28 Preparing for cleaning... 28 Disassembly... 28 Depth gauge FW042R... 28 Taps SZ051R to SZ053R... 28 Variable drill guide SZ054R... 29 Universal drill guide SZ055R... 29 Rod benders, all instruments with springs and ratchets... 29 Bone probe SZ024R... 29 Rod bender SZ076R... 29 Linear rod persuader SZ080R... 30 Persuador Pistol Style SZ082R... 30 Cleaning/Disinfection... 30 Product-specific safety information on the reprocessing method... 30 Validated cleaning and disinfection procedure... 31 Manual cleaning/disinfection... 32 Manual cleaning with immersion disinfection... 32 Manual cleaning with ultrasound and immersion disinfection 33 Mechanical cleaning/disinfection... 34 Mechanical alkaline cleaning and thermal disinfecting... 34 Mechanical cleaning/disinfection with manual pre-cleaning. 35 Manual pre-cleaning with a brush... 35 Manual pre-cleaning with ultrasound and brush... 36 Mechanical alkaline cleaning and thermal disinfecting... 36 Inspection... 37 Visual inspection... 37 Functional test... 37 Assembly... 37 Depth gauge FW042R... 37 Taps SZ051R to SZ053R... 37 Variable drill guide SZ054R... 38 Universal drill guide SZ055R... 38 Rod benders, all instruments with springs and ratchets... 38 Bone probe SZ024R... 38 Rod bender SZ076R... 38 Linear rod persuader SZ080R... 38 Persuader Pistol Style SZ082R... 39 Packaging... 39 Steam sterilization... 39 Storage... 39 Technical service... 39 Disposal... 39

3

en 1.

About this document

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

1.1

Scope

These Instruction for Use apply to the Ennovate Cervical Basic technique. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on mate-

rial compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1 Intended use The Ennovate Cervical instruments are used for the implantation of Ennovate Cervical system implants. The indications and contraindications are described in the Instruction for Use of the Ennovate Cervical implants TA015777. 2.1.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Chapter 2.1.1.

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.1.3 Contraindications For contraindications, see Chapter 2.1.1.

2.2

Safety information

2.2.1

Clinical user

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

4

en 2.2.2

Product

2.2.3

Sterility

Product-specific safety information These Instruction for Use apply to the Ennovate Cervical Basic technique. For the operating manual of the Basic technique and for all other surgical techniques, please refer to following documents:

Non-sterile, reusable products

Art. no.

Designation

SZ001R

Ennovate Cervical ratchet handle straight

TA015777

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

SZ002R

Ennovate Cervical drill handle tear drop style

SZ003R

Ennovate Cervical drill handle palm style

SZ005R

Ennovate Cervical torque limiting T-Handle

SZ006R

Ennovate Cervical torque limiting handle straight

SZ008R

Ennovate Cervical counter torque handle

TA015762

IFU ENNOVATE CERVICAL NAVIGATED INSTRUMENTS

TA015760

IFU ENNOVATE CERVICAL INSTRUMENTS FOR OCCIPITAL FIXATION

Art. no.

Designation

Ennovate Cervical Set Basic

TA015761

IFU ENNOVATE CERVICAL C1/C2 INSTRUMENTS

SZ050R

Ennovate Cervical center punch

TA015766

IFU ENNOVATE CERVICAL MIS INSTRUMENTS

SZ048R

Ennovate Cervical fixed drill guide, 12 mm

TA015755

IFU ENNOVATE CERVICAL TRAYS

SZ049R

Ennovate Cervical fixed drill guide, 14 mm

TA013082

IFU SECURESPAN

SZ054R

TA013131

IFU SECURESPAN INSTRUMENTS

Ennovate Cervical variable drill guide for 3.5 mm / 3.6 mm and 4.0 mm screws

O03102

ENNOVATE CERVICAL - SURGICAL TECHNIQUE

SZ055R

Ennovate Cervical universal drill guide OPEN/NAV (incl. 3.5 mm and 4.0 mm tube)

O03202

ENNOVATE CERVICAL NAVIGATION - SURGICAL TECHNIQUE

SZ143R

Ennovate Cervical MIS universal drill guide (incl. 3.5 mm / 3.6 mm and 4.0 mm tube)

O03302

ENNOVATE CERVICAL MIS - SURGICAL TECHNIQUE

SZ058R

O47602

SECURESPAN – SURGICAL TECHNIQUE

Ennovate Cervical tube for universal drill guide ∅ 4.5 mm screws

SZ063R

Ennovate Cervical screwdriver for polyaxial screws

SZ064R

Ennovate Cervical ball end screwdriver for polyaxial screws

SZ065R

Ennovate Cervical screw body manipulator

SZ066R

Ennovate Cervical sounder

SZ068R

Ennovate Cervical set screw starter double-ended

SZ069R

Ennovate Cervical set screw starter single-ended

SZ070R

Ennovate Cervical set screw torque/removal driver shaft

FW076R

Ennovate Cervical / S4 Cervical rod holding forceps

SZ075R

Ennovate Cervical rod cutter

SZ077R

Ennovate Cervical rod cutter CoCr

SZ076R

Ennovate Cervical rod bender

FW024R

Spinal rod bending forceps

SZ080R

Ennovate Cervical persuader in-line

FW042R

Ennovate Cervical / S4 Cervical pedicle depth gauge

SZ022R

Ennovate Cervical bone probe blunt straight

SZ023R

Ennovate Cervical bone probe blunt curved

SZ024R

Ennovate Cervical bone probe straight thoracic cannulated

SZ025R

Ennovate Cervical obturator for can. bone probe

SZ026R

Ennovate Cervical bone probe thoracic straight

SZ027R

Ennovate Cervical bone probe thoracic curved

FW674R

Ennovate Cervical / S4 Cervical bone probe straight

FW675R

Ennovate Cervical / S4 Cervical bone probe curved

► Only combine Aesculap products with each other. ► Only use Aesculap Ennovate instruments and accessories. ► Always adhere to applicable standards. ► Observe the graphic/packing template when storing the instruments. ► Use the product only in applications according to its intended use, see

Chapter 2.1.1. Instruments can fall in situ or on the floor! Handles can loosen during use! ► Check the seating of the coupling handles on the instruments for tightness. Injury of spinal cord, nerve roots and blood vessels due to piercing of the cortex in case of incorrect application! ► Only carry out alignment and insertion of the instruments and polyaxial screws under radiographic control or with the aid of a navigation system.

5

en Art. no.

Designation

Ennovate Cervical Set Complementary SZ001R

Ennovate Cervical ratchet handle straight

SZ063R

Ennovate Cervical screwdriver for polyaxial screws

SZ080R

Ennovate Cervical persuader in-line

SZ081R

Ennovate Cervical rod persuader Basic

SZ082R

Ennovate Cervical rod persuader pistol style

SZ051R

Ennovate Cervical tap ∅ 3.5 mm / ∅ 3.6 mm

SZ052R

Ennovate Cervical tap ∅ 4.0 mm

SZ029R

Ennovate Cervical caliper for cross connectors

SZ030R

Ennovate Cervical template for SQ020TS domino lateral 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm

SZ031R

Ennovate Cervical template for SQ021TS domino lateral 3.5 mm / 4.0 mm to 5.5 mm

SZ032R

Ennovate Cervical template for SQ022TS domino axial 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm

SZ033R

Ennovate Cervical template for SQ023TS domino axial 3.5 mm / 4.0 mm to 5.5 mm

SZ034R

Ennovate Cervical template for SQ024TS domino lateral 3.5 mm / 4.0 mm to 5.5 mm

Non-sterile single-use products Art. no.

Designation

SZ016R

Ennovate Cervical drill ∅ 2.3 mm solid for universal drill guide

SZ017R

Ennovate Cervical drill ∅ 2.8 mm solid for universal drill guide

SZ018R

Ennovate Cervical drill ∅ 3.3 mm solid for universal drill guide

SZ019R

Ennovate Cervical drill ∅ 2.3 mm for variable/fixed drill guide

SZ020R

Ennovate Cervical drill ∅ 2.8 mm for variable/fixed drill guide

SZ010R

Ennovate Cervical K-wire ∅ 1.0 mm for 3.6 mm screws

SZ011R

Ennovate Cervical K-wire ∅ 1.5 mm for 4.0 mm and 4.5 mm screws

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

Designation

SZ035R

Ennovate Cervical template for SQ025TS domino lateral 3.5 mm / 4.0 mm to 3.5 mm / 4.0 mm

SZ016SU

Ennovate Cervical drill ∅ 2.3 mm solid for universal drill guide

SZ036R

Ennovate Cervical template for SQ010TS offset-connector

SZ017SU

Ennovate Cervical drill ∅ 2.8 mm solid for universal drill guide

SZ039R

Ennovate Cervical handle for connector templates

SZ018SU

SZ089R

Ennovate Cervical locking driver for head-to-head connector

Ennovate Cervical drill ∅ 3.3 mm solid for universal drill guide

SZ019SU

Ennovate Cervical drill ∅ 2.3 mm for variable/fixed drill guide

SZ020SU

Ennovate Cervical drill ∅ 2.8 mm for variable/fixed drill guide

SZ072SU

Ennovate Cervical rod bending template 60 mm

SZ073SU

Ennovate Cervical rod bending template 150 mm

SZ074SU

Ennovate Cervical rod bending template 290 mm

SZ010SU

Ennovate Cervical K-wire ∅ 1.0 mm for 3.6 mm screws

SZ011SU

Ennovate Cervical K-wire ∅ 1.5 mm for 4.0 mm and 4.5 mm screws

SZ053R

Ennovate Cervical tap ∅ 4.5 mm

SZ078R

Ennovate Cervical in-situ rod bender

FW071R

Ennovate Cervical / S4 Cervical lamina preparator

FW528R

Ennovate Cervical / S4 Cervical hook holding forceps curved

FW427R

Ennovate Cervical / S4 Cervical compression forceps

FW428R

Ennovate Cervical / S4 Cervical distraction forceps

FW036R

Ennovate Cervical / S4 Cervical rod bending plates

► Inspect the new product after removing its transport packaging and

prior to first use to ensure it is in good working order. The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior

to its initial sterilization.

The product has been sterilized by irradiation and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. ► Do not reuse the product. The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

6

en 3.

Application

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

3.1

Safe application

When using K-wires, observe the following two warning notices: DANGER Injury of the spinal cord, nerve roots and blood vessels due to piercing of the cortex in case of incorrect application! ► Only carry out alignment and insertion of the instruments, K-wires and polyaxial screws under radiographic control or with the aid of a navigation system. ► Carefully guide the instruments over the K-wires. When doing this, make sure that the K-wire remains in its position. It is recommended to hold the K-wire and to check the striped marking on the K-wires. ► Do not bend K-wires. Immediately replace bent K-wires. ► Inspect the cannulation of the instruments for blockage 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. ► 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. ► Only use K-wires SZ010SU/SZ010R, SZ011SU/SZ011R of the Ennovate Cervical system. WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or missing components. ► Always carry out a function test prior to each use of the product. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. WARNING Risk of injury to patients due to damaged instruments! Ennovate Cervical instruments are precise and can be easily damaged! ► Handle Ennovate Cervical instruments with the greatest of care. ► Do not repair or modify the instruments (e.g. sharpening of the tips). In case of malfunction send them to Aesculap Technical Service .

3.2

Prepare screw hole with center punch 11 (SZ050R)

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue in case of a too deep penetration of the center punch! ► Never insert the center punch beyond the raised edge. ► Do not use the center punch in case of poor bone quality. ► Determine the entry point and alignment of the polyaxial screw.

a

11

Fig. 1 ► Use the center punch 11 (SZ050R) to open the cortex.

A raised edge a is provided on the center punch, to indicate when the ideal depth has been reached, see Fig. 1. ► Alternatively, make a 1 mm to 2 mm drill hole using a small decortication burr.

3.3

Drill holes for the Ennovate Cervical screws

The drill can be driven manually with a drill handle palm style (SZ003R) / drill handle tear drop style (SZ002R) or with a motor system and an AO small drill attachment (e.g. GB623R). The drill must be applied with a drill guide. The following guides can be used: ■ Variable drill guide 14 (SZ054R) for ∅ 3.5 mm and ∅ 4.0 mm screws ■ Universal drill guide 15 (SZ055R) for navigated procedures and ∅ 4.5 mm screws DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling the holes! ► Always use the correct Ennovate Cervical drill guides when drilling the holes. ► Do not combine drills and guides incorrectly. DANGER Injury to spinal cord and nerve roots caused by application of a drill that is too long! ► Use an appropriate imaging technique to select an appropriate drill length prior to the operation. ► Align and insert the drills only under radiographic monitoring and/or aided by a navigation system. ► Select the drill depth on the guide according to the intended hole depth.

7

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

► Mount the drill on the chosen handle. To insert the drill 9/10

(SZ019SU/SZ019R, SZ020SU/SZ020R) in the handle 2/3 (SZ002R/SZ003R), see Fig. 2: – Pull back the locking sleeve a. – Insert the drill 9/10 up to the stop in the tool holder b of the attachment. – Release the sleeve a. The drill is attached. ► Pull at the drill 9/10 to check that it is securely coupled. a

Note When using the MIS universal drill guide SZ143R, refer to the instructions for use for Ennovate Cervical MIS instruments TA015766. 3.3.1 Use variable drill guide 14 (SZ054R) For better identification the variable drill guide and corresponding drills are marked with a blue ring. The positive stop of the drills are color-coded to match the color of the screw heads: ■ The ∅ 2.3 mm drill 9 (SZ019SU/SZ019R) is required for the ∅ 3.5 mm / ∅ 3.6 mm polyaxial screws (silver). ■ The ∅ 2.8 mm drill 10 (SZ020SU/SZ020R) is required for the ∅ 4.0 mm polyaxial screws (gold). DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole of an inaccurate size! ► Make sure to use the correct drill. Check the color coding and laser marking.

14

Fig. 3 ► Set the desired drilling depth on the variable drill guide 14 (SZ054R) by

rotating the inner sleeve a counter-clockwise, see Fig. 3. Note The variable drill guide offers a range of lengths up to 40 mm. Fixed 12 mm and 14 mm drill guides are available on special request: SZ048R (12 mm) and SZ049R (14 mm).

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole that is too deep or too shallow! ► Check the laser marking on the guide. ► Always check the drill lengths with the guide sleeve that is being used with a caliper prior to drilling. 10 mm

► Select the appropriate drill.

10 mm

2/3

Fig. 4 a 9/10

Fig. 2

8

b

► Check the depth: Insert the required drill into the guide up to the pos-

itive stop and verify the exposed length of the drill with a caliper (e.g. AA845R), see Fig. 4.

en 2/3

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

14

► Attach the drill to the handle, see Chapter 3.3.1, see Fig. 2.

9/10 c

Fig. 5 ► Position the guide at the desired entry site and advance the drill until

the stop is reached, see Fig. 5. ► To uncouple the drill 9/10 from the handle 2/3:

– Pull back the locking sleeve a, see Fig. 2. – Remove the drill 9/10. 3.3.2

Use universal drill guide 15 (SZ055R)

For a quick identification, the tubes are marked with a color-coded ring according to the screw head color: ■ Silver ring for ∅ 3.5 mm / ∅ 3.6 mm tube ■ Golden ring for ∅ 4.0 mm tube ■ Green ring for ∅ 4.5 mm tube 17 (SZ058R) WARNING Delay of surgery due to inaccurate hole position! ► Make sure to select the right tube. Check the color coding. ► Select the appropriate drill guide tube.

Fig. 7 ► Set the desired drilling depth by rotating the inner sleeve c of the drill

guide: turn it counter-clockwise to increase the depth and clock-wise to decrease the depth (as indicated by the arrow on the inner sleeve c), see Fig. 7. DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole that is too deep or too shallow! ► Check the laser marking on the guide. 20 mm

15

b a

20 mm

Fig. 6

Fig. 8

► Attach the tube a to drill guide body b, see Fig. 6. The positive stop of the drills is color-coded to match the color of the screw heads: ■ ∅ 2.3 mm drill 7 (SZ016SU/SZ016R) for ∅ 3.5 mm / ∅ 3.6 mm polyaxial screws (silver) ■ ∅ 2.8 mm drill 8 (SZ017SU/SZ017R) for ∅ 4.0 mm polyaxial screws (gold) ■ ∅ 3.3 mm drill 43 (SZ018SU/SZ018R) for ∅ 4.5 mm polyaxial screws (green)

► Insert the required drill into the guide up to the positive stop and verify

the exposed length of the drill with a caliper (e.g. AA845R), see Fig. 8. DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling the holes! ► Always check the drill lengths with the guide sleeve being used with a caliper before starting to drill.

9

en 2/3

DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! ► Insert the bone probe carefully. Avoid levering and bending during insertion. ► Do not insert the bone probe too deep. Check the depth with the laser-marked scale. Verify suitable depth via radiographic control.

15

7/8/43

WARNING Delay of surgery if the curved bone probe is inserted in the wrong direction. ► Check the groove on the shaft. ► Prepare the channel with the chosen bone probe under radiographic

control to the desired depth. Fig. 9

36/40/42

► Position the guide 15 at the desired entry site and advance the

drill 7/8/43 until the stop is reached, see Fig. 9.

3.4

Use bone probes

Alternatively to drilling holes for the Ennovate Cervical screws, the pedicle preparation can be performed with bone probes. The probes are available in different designs: blunt, sharp, straight, curved. All probes are equipped with a scale to indicate the penetration depth in the bone: ■ Cervical probes 35, 36, 41, 42 (SZ022R, SZ023R, FW674R, FW675R) with diameter 2.3 mm are dedicated for 3.5 mm / 3.6 mm screws. ■ Thoracic probes 39, 40 (SZ026R, SZ027R) with a diameter of 2.8 mm are dedicated for 4.0 mm screws (marked with golden color coding ring). They can be used to prepare holes for 4.5 mm thoracic screws.

b

Fig. 11 ► Make

35/36/39–42

sure to insert the curved bone probes 36/40/42 (SZ023R/SZ027R/FW675R) in the right direction, use groove b for orientation.

Insert 4.0 mm and 4.5 mm screws with K-wire (optional)

33

a

a 38

38 37

Fig. 10 Note To determine the depth in the channel, the probes have ring markings a at 10 mm intervals, see Fig. 10. DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue! Risk of revision in case of screw loosening or pedicle break when preparing a hole of an inaccurate size! ► Make sure to use the right probe. Check the color coding and laser marking.

10

37

37

Fig. 12 Ennovate Cervical offers a thoracic cannulated bone probe 37 (SZ024R) that can be assembled with an obturator 38 (SZ025R), as can be seen on the left side of the image, see Fig. 12. ► Insert the assembly in the same manner as the solid bone probe. ► Once the desired depth is reached, remove the obturator 38 by loosening the golden knob a counter-clockwise. ► Insert the K-wire 33 through the cannulation of the bone probe 37. ► Remove the bone probe 37 while leaving the K-wire 33 in the prepared hole.

en 3.5

Confirm depth

Note This step cannot be performed when using K-wires.

21

3.6

K-wires can be used as guidance for screw placement. ► Insert the ∅ 4.0 mm and ∅ 4.5 mm screws over a 1.5 mm guidewire (SZ011SU/SZ011R, golden color coding). ► Insert the ∅ 3.6 mm screws over a 1.0 mm K-wire (SZ010SU/SZ010R). ► When tapping and inserting the screws over the K-wire, make sure that the K-wire does not advance unintendedly. ► For information on the safe use of K-wires, see Chapter 3.1.

3.7

Fig. 13 ► Use the sounder 21 (SZ066R) to confirm the depth of the prepared hole

Use K-wires as guidance for screw placement (optional)

Cut thread with tap (optional)

Ennovate Cervical screws are equipped with a fully threaded, tapered tip to reduce the need to tap. The use of a tap is recommended in case of hard bone. This step is optional. The taps are equipped with a self-retracting sleeve which helps to avoid the risk of damaging surrounding tissue during tapping. The taps, like the drills, are color-coded in accordance to the screw size: ■ Silver: tap 44 (SZ051R, tap ∅ 3.5 mm / ∅ 3.6 mm) ■ Gold: tap 45 (SZ052R, tap ∅ 4.0 mm) ■ Green: tap 46 (SZ053R, tap ∅ 4.5 mm)

and the integrity of the wall, see Fig. 13. 1

c

44/45/46 34

Fig. 15 Fig. 14 ► Use the pedicle depth gauge 34 (FW042R) to measure the desired

depth of the hole by using the retractable sleeve, see Fig. 14. The pedicle depth gauge 34 (FW042R) is marked in 2 mm intervals. Note The displayed depth reflects the actual screw thread length to be used as well as the depth of the hole, e.g. a 24 mm depth gauge reading represents a 24 mm drill depth as well as that a polyaxial screw with the length of 24 mm has to be selected.

The ratchet straight handle 1 (SZ001R) can be moved to the following positions by rotating the collar of the handle, as shown on the right side of the image, see Fig. 15: ■ Forward (IN): for tapping ■ Locked (•): blocks the ratchet ■ Reverse (OUT): for removing tap from the bone Note The Ennovate Cervical taps are cannulated to allow guided tapping over a K-wire. DANGER Risk of tissue injury or stripping bone threads when inserting the tap! ► Always check if the sleeve retracts correctly prior to applying the Ennovate Cervical tap.

11

en DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue if the tap or K-wire goes too deep. ► Check the depth on the laser-marked scale. ► Hold the K-wire and check the striped marking on the wire to make sure that the K-wire does not advance unintendedly. DANGER Revision required in case of screw loosening or bone breakage! Damage or breakage of instruments! ► Hold screw tap axially to the prepared hole and to the K-wire when turning in and out. Avoid levering, bending and strong applications of force when doing so. ► Make sure to use the right tap size. Check the color coding and laser marking. ► Select the correct tap. Check the color coding and laser marking. ► To attach the tap 44/45/46 to the ratchet straight handle 1 (SZ001R),

push the ratchet straight handle 1 onto the hex connection of the corresponding tap 44/45/46 up to the stop, see Fig. 15. ► Align the rotation setting 'IN' with the laser marked line (or keep it locked to block the ratchet). ► Position the tap 44/45/46 on previously prepared entry point and cut thread to the required depth by rotating clockwise while maintaining the appropriate trajectory.

a c a b

b

Fig. 16

3.8

Insert screw

DANGER Incorrect application can result in trauma to the spinal cord and nerve roots! Severe or fatal hemorrhage as a result of vascular injury! ► Check the insertion of screws by radiographic monitoring and/or with the aid of a navigation system. ► Take care not to breach the anterior and lateral cortices when screwing in the screw. ► Ensure that the vessels and nerves are not eroded, punctured during implantation or damaged as a result of implant breakage or migration after implantation. ► Take care to avoid pulsatile erosion of the vessels and nerves because of close apposition of the implants. WARNING Risk of injury to the patient if the polyaxial screw is damaged during removal from the packaging! ► When connecting the polyaxial screw with the screwdriver SZ063R never brace it against the packaging. WARNING Operation delay! Damage to the polyaxial screw if the screwdriver is not correctly engaged in the screw! Torque cannot be transferred to the screw! ► Connect the screwdriver completely to the screw. ► Check that the polyaxial screw is firmly attached to the screwdriver. ► Verify the axial alignment of the polyaxial screw to the screwdriver. – Only allow the axial load on the screw during screw insertion. – Avoid the induction of lateral forces. ► Hold the screwdriver axially to the prepared hole when turning in and out. Avoid levering, bending and strong applications of force when doing so. CAUTION Delay of surgery due to wrong screw selection! ► Check the laser marking and color-coding.

► Read the depth from the scale a as the sleeve b retracts during tapping,

see Fig. 16. ► Align the rotation setting 'OUT' with the laser marked line (or keep it

locked to block the ratchet). ► Unscrew the tap counter-clockwise. ► Verify the integrity of the pre-drilled hole and cortex of the vertebral

L

body with sounder 21 (SZ066R). ► Loosen the tap 44/45/46 from ratchet straight handle 1 by pulling on the black sleeve c.

Fig. 17 Note The screw length L is measured from the tip of the screw to the sphere of the screw shaft, see Fig. 17. To ensure maximum polyaxiality with the screw, do not tighten the screw completely down to the bone. Leave a small gap below the head to allow rotation and angulation of the screw head.

12

en ► Select the appropriate screw (diameter, length, and type).

1 1

c d

a

f

b

18

18

Fig. 20 Fig. 18

► Make sure that the screw is firmly seated on the screwdriver and the

► Set the rotation direction setting on the handle to ‘IN’ (or keep it locked

to block the ratchet). ► Push the straight handle 1 (SZ001R) onto the hex connection a of the screwdriver 18 (SZ063R) up to the stop, see Fig. 18.

polyaxiality is blocked for insertion, see Fig. 20. ► Insert the screw while maintaining the appropriate trajectory. Use the

outer rotational sleeve f to better hold the screwdriver while screwing. ► After insertion of the screw, rotate the golden knob d counter-clock-

wise to release the screwdriver. ► Pull the black sleeve c of the handle 1 while pulling the screwdriver 18

out of the handle. d

d

b e

18

b e

Fig. 19 ► Place the tip b of the screwdriver into the head e of the screw until the

tip b of the screwdriver sits in the socket of the polyaxial screw and thus axially aligns to the screw shaft, see Fig. 19. ► Screw in the screwdriver 18 into the thread of the polyaxial screw e up to the stop by rotating the golden knob d clockwise until the screwdriver thread engages the screw head e and tighten the golden knob d. Fastening is complete when the polyaxial alignment of the polyaxial screw is completely blocked.

DANGER Injury to the spinal cord, nerve root and blood vessels due to piercing of the cortex and faulty screw placement due to screw loosening when used improperly! ► Ensure the axial alignment of the polyaxial screw to the K-wire when screwing in. When doing this, make sure that the K-wire remains in its position. ► When inserting the screw over the K-wire make sure that the Kwire does not advance forward. It is recommended to hold the Kwire and to check the striped marking on the wire. ► Remove the K-wire before the screw is completely screwed in to ensure that the K-wire does not advance forward. ► Do not remove the K-wire too early, otherwise the polyaxial screw guidance will fail. Note The Ennovate Cervical screwdrivers are cannulated to allow guided screw insertion over a K-wire. ► When using K-wires, observe the warnings described for using K-wires,

see Chapter 3.1.

13

en 3.9

Align screw head

3.11 Cut rod

Once the screw is inserted, the position of the polyaxial head can be optimized for rod insertion. The polyaxial screw body can be rotated by 360° and angled up to 90°. The ∅ 4.0 mm favored angle screws provide additional angulation in the cephalad and caudal directions for a total of 110° with +/- 65° cone angulation.

DANGER Risk of damage to patient, personnel or equipment in the operating room due to flying fragments from cut rod! ► Always hold the piece of rod to be cut at both ends. ► Use rod cutter 27 (SZ075R) to cut titanium rods.

20

► Use rod cutter 28 (SZ077R) to cut titanium and cobalt chrome rods and

20

for a smoother rod cut result. ► If desired, file sharp edges left after cutting the rod with a suitable instrument, such as the Aesculap durogrip file OL429R. 3.11.1 Cut rod with rod cutter 27 (SZ075R) ► To avoid projection, use the rod holding forceps 25 (FW076R) to grasp the small piece to be cut.

a b

Fig. 21 ► To optimize the position of the head, use the screw body

manipulator 20 (SZ065R), see Fig. 21. – Place the working end a of the screw body manipulator in the head of the polyaxial screw b. – Adjust the head angle as desired. Note If the screw is inserted too far, polyaxial movement of the screw body will be impeded due to bone contact. If the screw is inserted too deep, turn the screw counter-clockwise using the ball end screwdriver 19 (SZ064R) or with the screwdriver 18 (SZ063R) attached to the ratchet handle straight 1 (SZ001R) (rotation setting set to 'OUT' or locked). until full polyaxial motion is achieved.

27

b

Fig. 22 ► Cut rod with scissors a or center hole b of the rod cutter 27, see

Fig. 22. 3.11.2 Cut rod with rod cutter 28 (SZ077R) Note It is not possible to cut the rods at the location where it is excessively bent, as it won’t be possible to insert the rod into the rod cutter. Use the rod cutter SZ077R before bending the rods.

3.10 Select rod The Ennovate Cervical rods are supplied in a straight design (excluding pre-bent rods for the occipital plate and curved MIS rods). Their curvature can be adjusted to the required spine lordosis using the bending instruments. Exact contouring of the rods is essential to the successful assembly of the system. ► Determine the correct rod length and curvature that enable the rod to smoothly fit inside the heads of the polyaxial screws (or hooks). ► Use a rod bending template to aid in rod contouring or trimming to the required length (optional). Rod templates exist in lengths of 60 mm, 150 mm and 290 mm (SZ072SU, SZ073SU, SZ074SU). For differentiation the rods are color-coded: ■ Silver: 3.5 mm rods ■ Gold with blue orientation line: 4.0 mm titanium rods ■ Silver with white orientation line: 4.0 mm cobalt chrome rods ► Select the appropriate rod (according to the diameter, length and material).

a

c

e

b

28

f a

d

8 mm

Fig. 23 ► Make sure that the handles a of the rod cutter 28 (SZ077R) are in a

free, relaxed and open position. ► Mark cutting location on the rod. ► Rotate the large knob b clockwise until both arrows f are aligned. ► Slide the rod d into the center hole c of the rod cutter.

14

en ► Repeatedly squeeze the handles until the rod is cut.

The rod will be cut at the side of the rod cutter marked with “cutting line” e, as shown on the right side of the image, see Fig. 23. The cutting line is located approx. 8 mm from the upper surface of the instrument.

3.12.1 Bend rod with spinal rod bending forceps 30 (FW024R) b

a

30

c

3.12 Bend rod To bend cobalt chrome rods use the spinal rod bending forceps 30 (FW024R). To bend titanium rods use the spinal rod bending forceps 30 or the Ennovate Cervical rod bender 29 (SZ076R). Alternatively to the rod bender, Ennovate Cervical offers rod bending plates 66 (FW036R) as well as in situ rod benders 61 (SZ078R) which can be used to bend titanium and cobalt chrome rods. Titanium is highly notch-sensitive and therefore care must be taken during rod contouring to ensure that surface damage to the rod is minimal. This is necessary to avoid potential fatigue failure of the implant. When using cobalt chrome rods please be aware that due to the material characteristics sharp bends (e.g. not smaller than a radius of 50 mm or 130°) should be avoided. If sharper bends are needed bend the rod in several steps while changing positions along the rod. Note For long Ennovate Cervical rods, bending should be carried out in several steps in order to avoid excessive or insufficient lordosis. DANGER Damage to and breakage of the Ennovate Cervical rods caused by excessive strain on the material! Danger of injury from damage (breakage) of the rod if bent incorrectly! ► Always bend the rods in one direction only. Do not bend back the rods. ► Always use Ennovate Cervical bending instruments for bending the rods. ► Avoid small bending radii, notching or scratching of the rods. ► Always use Ennovate Cervical cutting instruments for cutting the rods. WARNING Delay of surgery due to incorrect bending of the rod! Rod cannot be inserted into the polyaxial screw head! Rod cannot be fastened! ► Avoid severe rod bending in the region of the polyaxial screw. ► Adjust the curvature of the rod to the anatomical situation. WARNING Delay of surgery due to wrong sequence in the surgery when using rod cutter SZ077R! ► Make sure to cut the rod before bending the extremities, as bent extremities will not fit into the rod cutter.

b

c

Fig. 24 ► Select the radius (small, medium, large) by pulling and turning the knob

a, see Fig. 24. ► Place the rod between the rollers b and the knob a. ► Repetitively squeeze the handles c.

3.12.2 Bend rod with Ennovate Cervical rod bender 29 (SZ076R)

b

b a

a

c

c

c

d

c

29

Fig. 25 ► Make sure that the rod bender is in its starting position, with the cen-

tral roller a moved completely back, see Chapter 4.13.7. ► Insert the rod between the central roller a and the two rollers b, see Fig. 25. ► Bend the rod to the desired radius by actuating the handle c of the rod bender. ► Repeatedly squeeze the handle until the desired contouring is achieved. ► To release the rod from the bender, press the release lever d and move the ratchet back to the starting position.

CAUTION Operation delay due to inability to bend cobalt chrome rod! ► Do not use rod bender 29 (SZ076R) to bend cobalt chrome rods. ► Use spinal rod bending forceps 30 (FW024R), or alternatively 61/66 (SZ078R/FW036R), to bend cobalt chrome rods. Note Rods with diameter of 4 mm have an orientation line that facilitates the alignment of the rod during the bending process, see Fig. 26. 15

en 26

b

29

29

e

3.13 Insert rod with rod holding forceps 25 (FW076R) WARNING 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 polyaxial screw! ► Insert 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 polyaxial screw before inserting the rod. b a

Fig. 26 As an optional bending guide, the rod bending template 26 (SZ073SU) can be inserted in the mounting on the distal roller for continuous visualization, as can be seen on the left side of the image, see Fig. 26. ► In case short rods need to be bent or the rod end needs to be contoured, insert the rod in one of the grooves e in front of the rollers.

25

3.12.3 Bend rod with rod bending plates 66 (FW036R) or in situ rod benders 61 (SZ078R) 66 61

Fig. 28 ► Insert the rod using the rod holding forceps 25 (FW076R), see Fig. 28. ► Close the handles a to engage the locking mechanism. ► Insert the rod in the rod slots of the polyaxial screws. ► Relieve the lock b by squeezing the handles a together.

WARNING Inadequate fixation due to incorrect positioning of the rod in the screw head! ► Check that the screw head is at a right angle to the rod. ► Check that the rod is securely positioned in the groove base. Fig. 27 ► To use the rod bending plates 66, insert the rod in the distal hole of the

bending plates. Contour the rod, see Fig. 27. ► To use the in situ rod benders 61:

– Position the in situ rod bender on the rod. – Contour the rod.

Fig. 29 ► Check that the screw head is at a right angle to the rod. ► Check that the rod is securely positioned in the groove base.

16

en ► Place set screw a with set screw starter 22/23 aligned axially to the

3.14 Insert set screw This step can only be performed where the rod is completely seated on the floor of the groove. If it is not, continue with the rod persuasion, see Chapter 3.15, WARNING Revision required! Inadequate fixation from screwing in at an angle/tilting of set screw (cross-threading)! ► Do not use the set screw to push the rod down. ► Make sure that the rod is correctly positioned on the floor of the groove before inserting the set screw. CAUTION Intraoperative revision required! Damage to the implant and instruments! Operation delay! ► Load the set screw correctly and completely with the set screw starter. ► Always place the set screw starter axially to the head of the polyaxial screw and do not tilt it.

22/23

22/23

3.15 Persuade rod DANGER Risk of severe injury if too much force is applied when persuading the rod! Polyaxial screw can tear out of the spinal column! Notching can occur on the rod due to too high forces! Revision required if rod breaks! ► Ensure that the forces applied when persuading the rod are not excessively high. ► Ensure that no notching occurs on the rod due to forces being too high. 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 of the screw head. Check correct positioning. ► Push the rod down completely up to the stop in the screw head. Make certain that the rod is positioned securely in the screw head. CAUTION Damage to and breakage of the rod persuader! ► Never use the rod persuader to bend the cervical rod. ► Never use the rod persuader to act as a counter torque for the Ennovate Cervical set screws.

b b

a

head of the polyaxial screw c and screw the set screw a into the head of the polyaxial screw c from the top until the set screw a contacts rod d, see Fig. 31.

a

3.15.1 Use rod persuader in-line 31 (SZ080R)

Fig. 30 ► Load the set screw on one of the set screw starters (22 (SZ068R) dou-

ble-ended or 23 (SZ069R) single-ended), see Fig. 30. Insert the working end b into the socket of the set screw a and push with light pressure. ► Verify solid seating of the set screw a on the set screw starter 22/23.

WARNING Delay of surgery due to the persuader not being in the starting position! ► Make sure that the golden knob is pulled up so that the 3 lines are visible. Note The text and arrows on the instrument indicate the directions in which the knob can be moved to reach different positions, e.g. the release position is reached by pulling up the knob. The arrows do not point to the lines, see Fig. 32. The starting position is reached when: ■ The knob can freely move between the second and third line. ■ The knob is pulled up, so that the 3 lines are visible.

22/23

a d

c

Fig. 31

17

en a a

a

a a

b

b

b

c

c

c

b b

c

Fig. 32

Fig. 34

► Check that the instrument is in the starting position, see Chapter 4.13.

► To disengage the persuader from the screw head, turn the golden

– Pull the golden knob a up to the third line as shown on the left side of the image, see Fig. 32. – Place the persuader over the head of the screw. ► Attach the persuader to the screw head c by releasing the golden knob d down to the second line as shown at the center of the image, see Fig. 32. The two arms on the distal end of the persuader b collapse and engage on the screw head c. ► Visually inspect the connection. In case of a faulty assembly, the next step cannot be performed. ► Persuade the rod by turning the golden knob a in the clockwise direction until the first line is reached as shown on the right side of the image, see Fig. 32. The rod is fully seated in the screw head c.

knob a counter-clockwise as far as possible (until the second line can be seen) and pull it up to the third line, see Fig. 34. Arms b spread and disengage from the screw head c. 3.15.2 Use rod persuader pistol style 48 (SZ082R) CAUTION Delay of surgery if the persuader is not in the start position! ► Make sure that the handle is pressed up against the forward stop. b

23

48

23

g a d e

31

b Fig. 35

f

48

c

► Release the bar a so that the handle b can move to the starting posi-

Fig. 33 ► Insert the set screw through the rod persuader in-line 31 (SZ080R)

using the single-ended set screw starter 23 (SZ069R), see Fig. 33.

tion, pressed up against the forward stop c. To release the ratchet, press down the bar at location e, see Fig. 35. ► Squeeze the handle b to attach the rod persuader 48 to the screw head f. ► Persuade the rod by further squeezing the handle b until the rod is fully seated in the screw head. ► Insert the set screw g through the rod persuader 48 using the singleended set screw starter 23 (SZ069R). ► To disengage the rod persuader 48, release the bar a so that the handle can move back to the starting position. Note When applying the rod persuader pistol style, the set screw can only be inserted using the single-ended set screw starter 23.

18