Silony Medical VERTICALE Navigation Manual de usuario

VERTICALE

Navigation

INSTRUMENTATION GUIDE

MADE IN GERMANY

TABLE OF CONTENTS

Introduction / Preface ................................................................................................................................................................................. 3

Indications / Contraindications .............................................................................................................................................................. 3

Preparation of Navigation system and instrumentation.............................................................................................................. 4

Prerequisites on Navigation system and tracker ...................................................................................................................... 4

Assembly of instruments .................................................................................................................................................................... 5

Assembly of Navigated shaft instruments .................................................................................................................................. 5

Instrument registration instructions ........................................................................................................................................... 6

Instrumentation / surgical steps ............................................................................................................................................................ 7

General Notes on use of Navigation instruments .................................................................................................................... 7

Position and approach ......................................................................................................................................................................... 8

Opening the cortex of the pedicle ................................................................................................................................................... 8

Open the pedicle canal with a probe ............................................................................................................................................. 8

Tapping (optional) .................................................................................................................................................................................. 9

Selection of screw .................................................................................................................................................................................. 9

Screw loading onto Navigated Screw Driver ............................................................................................................................. 10

Screw insertion ....................................................................................................................................................................................... 11

Further surgical steps .......................................................................................................................................................................... 11

PRODUCT INFORMATION ................................................................................................................................................................. PI 01

Instruments .............................................................................................................................................................................................. PI 02

Implants .................................................................................................................................................................................................... PI 03

The Navigation tracker shown in this instrumentation guide is representative for a variety of general navigation

tracker customary in the market.

NOTE: The following guide is intended to familiarize you with the surgical procedure and use of the VERTICALE®

Navigation Instrumentation. This instrumentation guide supplements the guides for the VERTICALE® Screw Rod

System. Instruments from Silony Medical are processed, serviced, and cared for in accordance with the information

given in the instructions for use. Please read this guide and the instructions for use accompanying the implants

carefully before using the implant, and also pay particular attention to the information appended to this guide. This

guide does not replace brieng by a surgeon experienced in the instrumentation used in spinal surgery. We would be

happy to assist you in nding a hospital that provides an opportunity to observe surgical procedures.

NOTE: Silony Medical is not a manufacturer of navigation systems or equipment. Please refer to the navigation

company’s software and user guides for instructions for use and training prerequisites on the navigation system.

Instructions for use and handling of any third-party navigation systems in combination with Silony instruments

are the responsibility of the hospital and navigation company. The navigation system should be set up per the

manufacturer’s instructions.

VERTICALE NAVIGATION 3

Navigation Instruments for Silony Medical VERTICALE® Screw Rod Systems

The Navigation Instruments for VERTICALE® are designed for compatibility with the Medtronic StealthStation®

Navigation System and the Medtronic NavLock™ tracker.

For general instructions on use, indications, contraindications and warnings please refer to the following manuals and guides:

VERTICALE® OPEN and MultiLocking Screw Rod System Instrumentation Guide

Instructions for Use VERTICALE implants

Instructions for Use Silony surgical instruments

Medtronic’s current navigation system software and user guides (StealthStation®, NavLock™)

Position Verication of VERTICALE® Navigation Instruments for VERTICALE® Spine Systems has been performed with

Medtronic StealthStation® S8 Navigation System and NavLock™ Tracker.

Physicians and operators of the system, instruments and software should read all related (Silony Medical and third-party)

user guides carefully before handling the equipment and have access to the user guides at all times. Prior to using the

VERTICALE® Navigated Instruments for VERTICALE® Screw Rod Systems, the physicians and operators should review the

Silony Medical VERTICALE® System guides for their indications for use.

Silony Medical navigation instruments for VERTICALE® Screw Rod Systems are NOT compatible with the implants from

other manufacturers. The VERTICALE® Navigation Instruments are intended for use with Silony Medical VERTICALE®

implants only:

• VERTICALE® Pedicle screws with short & reduction head

- VERTICALE® Polyaxial screw

- VERTICALE® Monoaxial screw

- VERTICALE® Uniplanar screw

- VERTICALE® Revision / Iliac screw

- VERTICALE® MultiLocking screw

INDICATIONS / CONTRAINDICATIONS

Please refer to the supplemental VERTICALE® system guides and Instructions for Use for general procedural instructions,

indications, contraindications and warnings.

Please consider the following additional information for Navigation use:

Additional Indications for Navigation use

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE®

pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures.

These instruments are designed for use with third-party stereotactic navigation system Medtronic StealthStation®,

which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where

reference to a rigid anatomical structure, such as vertebra, can be identied relative to a CT or MR based model,

uoroscopy images, or digitized landmarks of the anatomy.

Additional Contraindications for Navigation use

Medical conditions which contraindicate the use of a computer-assisted surgery system and its associated applications with

Silony Medical VERTICALE® system include any medical conditions which may contraindicate the medical procedure itself.

INTRODUCTION / PREFACE

NOTE: Please also note the Instructions for Use provided with each product. They may include additional advice that leads to

exclusion of the implant procedure.

All instrumentation guides and Instructions for Use can be found on our eLabeling portal (https://elabeling.silony-medical.com/)

PREPARATION OF

NAVIGATION SYSTEM

AND INSTRUMENTATION

Prerequisites on Navigation System and tracker

Note: For navigated instrumentation with Medtronic StealthStation®, the hospital’s Medtronic navigation

instrument set must include the Medtronic NavLock™ trackers. Silony Navigation Instruments require following the

instructions for use for the respective Medtronic navigation system and its navigation tracker, which are provided

by the navigation system manufacturer. If the respective third-party instrument tracker set is not available at the

hospital, the VERTICALE® Navigation Instruments cannot be navigated. In the event that the respective third-party

instrument tracker set is unavailable, a non-navigated technique using uoroscopy and respective Silony Medical

instrumentation may be adopted as per Silony Medical Instrumentation guides.

*Note: Position verication was performed with Medtronic StealthStation® System S8 and Software Version 1.2.0.

Navigation System Respective Instrument tracker / Array

Medtronic StealthStation® System S8* Medtronic NavLock™ tracker

VERTICALE NAVIGATION 5

Assembly of Navigated Shaft Instruments

1) Attach the corresponding Navigation tracker to the respective

Navigation Instrument (awl, probe, tap or SD Inner Shaft)* until

it snaps into place, make sure that the Navigation tracker is

securely connected to the respective instrument.

2) Attach Silony handle according to your preference to the

proximal interface of the instrument shaft*.

3) Additional steps for Navigated Screw Driver

The Navigated screw driver consists of a navigated driver shaft

in combination with modular components of the VERTICALE®

Screw driver VI-1130. Please refer to the instrument list

section at the end of this guide for combination options, e.g.

with SI-0024. For further (dis-)assembly instructions of the

modular screw driver VI-1130 or SI-0024, please refer to the

supplemental information provided with the instruments.

3.1) Attach your desired outer sleeve option onto

the Basic Core.

3.2) Instead of a non-navigated driver shaft, insert

the VI-7130 SD Inner Shaft into the respective

Screw driver Basic Core options.

* Further instrument options can be found in the instrument list

section at the end of this guide

** Further handle options can be found in the instrument list

section at the end of this guide

NOTE: Do not use the same tracker type/geometry on

two dierent instruments without new registration

procedure. For registration instructions, please refer to

the registration section.

Fig. 1 Attaching Navigation tracker to navigated shaft

instrument.

GI3111

Ratchet T-Handle**

Fig. 2 Assembling Navigated screwdriver shaft with Basic Core

of e.g. VI-1130.

NOTE: If the tracker cannot be rigidly connected to the

respective Silony Navigation Instrument, utilize Silony

standard non-navigated surgical technique as described

in the VERTICALE® system guides.

Follow the instructions for NavLock™ tracker.

Assembly of instruments

Note: For selection on tracker type or array size please

refer to the third-party’s user guides.

6 SILONY MEDICAL – Instrumentation Guide

Instrument Registration Instructions

Refer to the navigation manufacturer’s current navigation software and user guides for patient referencing and instrument

registration.

Follow the instructions for StealthStation® and NavLock™ tracker.

For each instrument to be navigated, assign the appropriate instrument tool card and tracker type/geometry in the navigation

software that has been attached to the respective instrument. Use the cross-reference table at the end of this guide for any

VERTICALE Navigation Instrument being used.

Upon successful registration, the trajectory and location of the distal tip of the instrument or screw are visually represented

within the software by the third-party instrument or screw selected from the corresponding tool cards. If you desire to change

the tip of the virtual representation to reect the diameter and length of the screw, follow the instructions of the chosen

navigation system.

VERTICALE NAVIGATION 7

Instrumentation / Surgical Steps

General Notes on use of Navigation instruments

The following section describes only the specic steps for the use of VERTICALE® Navigation instruments. For the general

instrumentation steps of the VERTICALE system for an open appraoch, we ask you to study the instrumentation guide for the

VERTICALE® OPEN Screw Rod system.

Please review the following notes prior to using VERTICALE® Navigation instruments.

• Prior to navigation, always conrm that accuracy of the instrument tip or tip of screw driver with rigidly connected

screw is in an acceptable range for the intended use by positioning the navigated tip on an identiable anatomical

landmark and comparing the actual tip location to that displayed by the system.

• Assess navigational accuracy repeatedly throughout a procedure.

• After each change to the navigated instrumentation assembly in use (e.g. for each new screw; after

re-attachment of tracker including array and spherical markers) when using a surgical navigation system, the

navigated instrumentation assembly must be re-veried for accuracy.

• Discontinue use if inaccuracy is suspected.

• If the stereotactic navigation system does not appear to be accurate or registration of Silony instruments fails

despite troubleshooting (e.g. resetting the system), do not rely on the navigation system. A non-navigated

technique using uoroscopy and respective Silony Medical instrumentation should be used as per Silony Medical

Instrumentation guides.

• If the desired virtual screw or instrument diameter is not available in the software, use the next larger available

size in diameter (e.g. Ø 5.2 mm screws Software: select Ø 5.5 mm screw projection).

• At all times during use, ensure the navigation tracker is visible to the camera of the respective navigation system

in use.

• For probes, taps and the screw driver, the navigation tracker will rotate around the instrument shaft. Please

hold the tracker with the hand for permanent camera visibility of the array markers while using the

instrument.

• For inserting taps and screws rotate proximal instrument handle clockwise, for removal rotate

anti-clockwise.

• Some instruments are equipped with an anti-rotation pin. For these instruments, the navigation tracker will

not rotate around the instrument shaft during use (only back and forth rotation allowed for permanent

camera visibility).

• Care should be taken to avoid bending forces on registered instruments during navigation procedure as deection

can inuence navigation accuracy.

• If instruments drop or may otherwise be damaged, re-verify them with respect to anatomical landmarks or use

another instrument. Do not use any instrument if verication of anatomical landmarks fails. Omission to

do so may lead to serious injury to the patient.

• Do not use the tracker and/or Silony Navigation instruments if any components appear to be loose, bent or

otherwise damaged.

• Cannulated instruments (taps, screw driver) are available for using guide wires

• The guide wires are not navigated instruments.

• Ensure that the length of the guide wire exceeds the length of implant, instrument and additional handle.

• Push the instrument over the placed guide wire

• Ensure the guide wire remains securely in position throughout the entire duration of the procedure.

• Remove the guide wire after screw insertion and conrming nal screw position.

VI7010

VERTICALE Nav Awl with Stop*

Assemble and register respective probe as described in

assembly and registration section. Please refer to general

notes section prior to navigation.

Please refer to the VERTICALE® OPEN Instrumentation Guide

for information on opening up the cancellous bone of the

vertebral body with a probe.

* Further instrument options at the end of this guide.

Open the pedicle canal with a probe

8 SILONY MEDICAL – Instrumentation Guide

Position and approach

Assemble and register respective awl as described in assembly

and registration section. Please refer to general notes section

prior to navigation.

Please refer to the VERTICALE® OPEN Instrumentation Guide

for information on opening the pedicle with an awl.

* Further instrument options at the end of this guide.

VI7024

VERTICALE Nav Thoracic Probe*

VI7025

VERTICALE Nav Lumbar Probe*

Please refer to the VERTICALE® OPEN Instrumentation Guide for information on patient position and approach.

Opening the cortex of the pedicle

VERTICALE NAVIGATION 9

Selection of screw

Select the VERTICALE® pedicle screw type and size (length

and diameter) based on pre-operative planning and

uoroscopic imaging. VERTICALE® Pedicle screws with

short & reduction head are compatible with VERTICALE®

Navigation Instruments:

• VERTICALE® Polyaxial screw

• VERTICALE® Monoaxial screw

• VERTICALE® Uniplanar screw

• VERTICALE® Revision / Iliac screw

• VERTICALE® MultiLocking screw

Assemble and register respective tap as described in assembly

and registration section. Please refer to general notes section

prior to navigation.

Please refer to the VERTICALE® OPEN Instrumentation Guide

for information on tapping with solid taps or cannulated taps

in combination with guide wires for guided insertion.

* Further instrument options at the end of this guide.

Tapping (optional)

VI7045

VERTICALE Nav Tap

4.5 + 5.2 mm*

VI7067

VERTICALE Nav Tap

6.2 + 7.2 mm*

10 SILONY MEDICAL – Instrumentation Guide

VI7130

VERTICALE Nav SD Inner Shaft

Fig. 3 Navigated screw driver with loaded screw.

NOTE: Please ensure the screw driver tip is fully seated

in the screw drive feature and the connection is rigid

after tightening

Screw loading onto Navigated Screw Driver

1) Assemble and register screw driver shaft as described in

assembly and registration section.

2) Adjust for short or long head screws, in analogy to VI-1130,

by pressing the button on the middle part of the handle of

the Screw driver basic core and pulling or pushing the driver

shaft into its dedicated position.

3) Loading screw, in analogy to VI-1130

The VERTICALE® pedicle screw driver tip is rst inserted

deeply into the inner drive feature of the screw shaft. After

that, the internal thread of the screw head is connected to

the external thread of the instrument by rotating clockwise

and applying gentle downward force with the instrument

shaft.

NOTE: For full instructions please refer to the VERTICALE®

OPEN Instrumentation Guide and supplemental

information provided with the instrument.

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