spine planning 1 · the spine & trauma navigation system enables computer-assisted navigation of...

SPINE PLANNINGVersion 1.0

Software User GuideRevision 1.1Date of issue: 2020-03-09 (ISO 8601)Copyright 2020, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS1 GENERAL INFORMATION.............................................................................................51.1 Contact Data ........................................................................................................................................5

1.2 Legal Information ...............................................................................................................................6

1.3 Symbols................................................................................................................................................7

1.4 Using the System ...............................................................................................................................8

1.5 Compatibility with Medical Devices and Software ......................................................................9

1.6 Training and Documentation..........................................................................................................11

2 SPINE PLANNING INTRODUCTION ..................................................................132.1 Getting Started ..................................................................................................................................13

2.2 Toolbar ................................................................................................................................................15

3 SCREW PLANNING ...........................................................................................................193.1 Proposed Screws .............................................................................................................................19

3.2 Manual Planning Workflow.............................................................................................................25

TABLE OF CONTENTS

Software User Guide Rev. 1.1 Spine Planning Ver. 1.0 3

TABLE OF CONTENTS

4 Software User Guide Rev. 1.1 Spine Planning Ver. 1.0

1 GENERAL INFORMATION1.1 Contact Data

Support

If you cannot find information you need in this guide, or if you have questions or problems, contactBrainlab support:

Region Telephone and Fax Email

United States, Canada, Centraland South America

Tel: +1 800 597 5911Fax: +1 708 409 1619

[email protected]

Brazil Tel: (0800) 892 1217 [email protected]

UK Tel: +44 1223 755 333

[email protected]

Spain Tel: +34 900 649 115

France and French-speakingregions Tel: +33 800 676 030

Africa, Asia, Australia, EuropeTel: +49 89 991568 1044Fax: +49 89 991568 811

JapanTel: +81 3 3769 6900Fax: +81 3 3769 6901

Expected Service Life

Brainlab provides eight years of service for software. During this period of time, software updatesas well as field support are offered.

Feedback

Despite careful review, this user guide may contain errors. Please contact us [email protected] if you have improvement suggestions.

Manufacturer

Brainlab AGOlof-Palme-Str. 981829 MunichGermany

GENERAL INFORMATION


mailto://[email protected]://[email protected]://[email protected]:[email protected]

1.2 Legal Information

Copyright

This guide contains proprietary information protected by copyright. No part of this guide may bereproduced or translated without express written permission of Brainlab.

Brainlab Trademarks

Brainlab® is a trademark of Brainlab AG.

Non-Brainlab Trademarks

Windows® is a registered trademark of Microsoft Corporation in the US and other countries.

Patent Information

This product may be covered by one or more patents or pending patent applications. For details,see: www.brainlab.com/patent.

Integrated Third-Party Software

This software is based in part on the following work. The full license and copyright notice can befound at the links below:• libjpeg-turbo (https://github.com/libjpeg-turbo/libjpeg-turbo/blob/master/LICENSE.md)• libtiff 4.0.4 beta (http://www.libtiff.org/misc.html)• Xerces-C++, developed by the Apache Software Foundation (https://xerces.apache.org/

xercesc/)

CE Label

The CE label indicates that the Brainlab product complies with the essential re-quirements of Council Directive 93/42/EEC (the “MDD”).Spine Planning is a part of the Spine & Trauma Navigation System, which isa Class IIb product according to the rules established by the MDD.

Sales in US

US federal law restricts this device to sale by or on the order of a physician.

Report Incidents Related to This Product

You are required to report any serious incident that may have occurred related to this product toBrainlab, and if within Europe, to your corresponding national competent authority for medicaldevices.

Legal Information


https://www.brainlab.com/patent/https://github.com/libjpeg-turbo/libjpeg-turbo/blob/master/LICENSE.mdhttp://www.libtiff.org/misc.html

1.3 Symbols

Warnings

WarningWarnings are indicated by triangular warning symbols. They contain safety-criticalinformation regarding possible injury, death or other serious consequences associatedwith device use or misuse.

Cautions

Cautions are indicated by circular caution symbols. They contain important informationregarding potential device malfunctions, device failure, damage to device or damage toproperty.

Notes

NOTE: Notes are formatted in italic type and indicate additional useful hints.

Product Symbols

Symbol Explanation

Unique Device Identifier

Consult instructions for use

Manufacturer

Medical Device

U.S. federal law restricts this device to sale by or on order of a physician

GENERAL INFORMATION


1.4 Using the System

Intended Use and Indications for Use/Intended Purpose

The Spine & Trauma Navigation System is intended as an intraoperative image-guidedlocalization system to enable minimally invasive surgery. It links a freehand probe, tracked by apassive marker sensor system to virtual computer image space on a patient's preoperative orintraoperative 3D image data.The Spine & Trauma Navigation System enables computer-assisted navigation of medicalimage data, which can either be acquired preoperatively or intraoperatively by an appropriateimage acquisition system. The software offers screw implant size planning and navigation on rigidbone structures with precalibrated and additional individually-calibrated surgical tools.The system is indicated for any medical condition in which the use of stereotactic surgery may beappropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, along bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopicimage and 3D fluoroscopic image reconstruction) and/or an image data based model of theanatomy.

Known Contraindications

There are no known contraindictions for the use of this device.

Place of Use

The planning tasks shall be performed in an office or in the operating room.The navigation tasks shall be performed in an operating room/suite.

User Profiles

Neuro / Ortho / Spine / Trauma surgeons or their assistants having a 3D image acquisition system(such as CT or 3D C-arm), or utilizing preoperatively acquired CT / CT like (and potentially fusedMR) imaging data in combination with a Brainlab navigation system.

Patient Population

The patient population includes any medical condition in which the use of stereotactic surgerymay be appropriate and where a reference to a rigid anatomical structure, such as the skull, thepelvis, a long bone or vertebra can be identified relative to the acquired image (CT, 3Dfluoroscopic image reconstruction).

Clinical Benefit

The Spine & Trauma Navigation System provides the following benefits:• Higher accuracy in placement of screw implants in comparison to conventional techniques• Reduced radiation dose for the operating staff in comparison to conventional techniques• Lower (intra-operative and post-operative) complication rate due to misplaced screws in

comparison to conventional techniques• The need for the patient to return to the operating room for revision surgery is reduced or

eliminated

Plausibility Review

WarningBefore patient treatment, review the plausibility of all information input to and output fromthe system.

Using the System


1.5 Compatibility with Medical Devices and Software

Non-Brainlab Devices

WarningUsing medical device combinations that have not been authorized by Brainlab mayadversely affect safety and/or effectiveness of the devices and endanger the safety of thepatient, user and/or environment.

Compatible Brainlab Medical Software

Only Brainlab medical software specified by Brainlab may be installed and used with the system.Contact Brainlab support for clarification regarding compatibility with Brainlab medical software.

Non-Brainlab Software

Only authorized Brainlab employees may install software on the Brainlab system. Do notinstall or remove any software applications.

Updates

WarningUpdates to the operating system (hotfixes) or third-party software should be performedoutside clinical hours and in a test environment to verify correct operation of the Brainlabsystem. Brainlab monitors the released Windows hotfixes and will know, for some updates,if problems can be expected. Contact Brainlab support if any problems to operating systemhotfixes are encountered.

Virus Scanning and Malware

Brainlab recommends protecting the system with state-of-the-art anti-virus software.Be aware that some malware protection software (e.g., virus scanner) settings can negativelyaffect system performance. For example, if real-time scans are performed and each file access ismonitored, then loading and saving patient data may be slow. Brainlab recommends disablingreal-time scans and performing virus scans during non-clinical hours.

WarningEnsure that your anti-virus software does not modify any Brainlab directories, specifically:• C:\Brainlab, D:\Brainlab, F:\Brainlab, etc.• C:\PatientData, D:\PatientData, F:\PatientData, etc.

WarningDo not download or install updates during treatment planning.Contact Brainlab support for further information regarding any of these issues.

Microsoft Security Updates for Windows and Driver Updates

Brainlab allows the installation of security patches only. Do not install service packs and optionalupdates. Verify your settings to ensure updates are downloaded and installed correctly and at asuitable time. Do not update drivers on Brainlab platforms.See the Brainlab website for more information about settings and a list of Microsoft SecurityUpdates blocked by Brainlab support.Address: www.brainlab.com/updates

GENERAL INFORMATION


https://www.brainlab.com/updates/

Password: WindowsUpdates!89

Compatibility with Medical Devices and Software


1.6 Training and Documentation

Brainlab Training

Before using the system, all users must participate in a mandatory training program held by aBrainlab authorized representative to ensure safe and appropriate use.

Responsibility

WarningThis system solely provides assistance to the surgeon and does not substitute or replacethe surgeon's experience and/or responsibility during its use. It must always be possiblefor the user to proceed without the assistance of the system.Only trained medical personnel may operate system components and accessory instrumentation.

Extended OR Time

Brainlab Navigation Systems are sensitive technical equipment. Depending upon OR setup,patient positioning, calculation durations and complexity, surgery duration using navigation mayvary. It is up to the user to decide whether a potential prolongation is acceptable for the respectivepatient and treatment.

Reading User Guides

This guide describes complex medical software or medical devices that must be used with care.It is therefore important that all users of the system, instrument or software:• Read this guide carefully before handling the equipment• Have access to this guide at all times

GENERAL INFORMATION


Training and Documentation


2 SPINE PLANNINGINTRODUCTION

2.1 Getting Started

Background

Brainlab Elements Spine Planning allows you to plan screws for surgical navigation. Dependingon the region of interest, screws can be automatically proposed by the software or plannedmanually.

How to Open Spine Planning

① ①

Figure 1

Step

1. Select a patient or add a new patient.

2. Optional: Select a disease classification.

3. Under the Spine & Trauma category, select Planning or 3D Navigation.

SPINE PLANNING INTRODUCTION


Step

4. Under the Planning or 3D Navigation category, select Screw Planning ①.NOTE: For more information see the Patient Data Manager Software User Guide.

Getting Started


2.2 Toolbar

Home Button

Select Home to return to your start page. All changes are saved and SpinePlanning remains running in the background. From the start page you canopen other Brainlab applications (e.g., Spine & Trauma 3D Navigation).

Zoom and View Menu

Figure 2

Function Description

Scroll Scroll up or down through all slices within a window.

Zoom• Drag up/left (zoom out) or down/right (zoom in).• When using a touchscreen, press two fingers on the image and pinch

inward (zoom out) or outward (zoom in).

Pan Drag to move a slice within a window.

Windowing Adjust the brightness and contrast by swiping across the slice.

NOTE: The zoom and viewing functions can be performed with touchscreen gestures or with amouse.



Data Menu

① ②

④

⑤

③

Figure 3

No. Component

① Open the Data menu to select patient data and planned items.

②Select MORE to load additional patient data.NOTE: From the loaded data, the software automatically selects the assumed best fit-ting image set (e.g., newest with the smallest slice distance).

③ Select the Objects, Screws or Points tab to view previously planned objects, screwsor points.

④ Use the eye icons to show/hide all objects, screws or points.

⑤ Use the eye icon to show/hide the selected object, screw or point.

Toolbar


Screw Properties

①

②

③

Figure 4

No. Component

① Edit screw Name as required.

② Enter a Comment for that screw, as required.

③ Select the Color button, then select the color you wish to assign that screw.



Toolbar


3 SCREW PLANNING3.1 Proposed Screws

Background

Based on your vertebra selection, the software proposes planned screws. These screws must bereviewed and approved before proceeding with navigated surgery.NOTE: Automatic screw proposal is available for standard thoracolumbar pedicle screwplacement. When planning screws in other spinal regions, use the manual planning workflow.

Various image modalities are compatible with Brainlab Elements Spine Planning, however,proposed screws are only provided when using CT and Cone Beam CT (X-ray) data.If the software fails to propose planned screws, proceed with manual screw planning.NOTE: If you wish to disable the proposed screw feature, contact Brainlab support. In that case,the target definition step is not available.

Related Links

Manual Planning Workflow on page 25

SCREW PLANNING


How to Define Target Area

①

②

③

Figure 5

Step

1. Select the vertebrae in which you plan to insert screws ①.The selected vertebrae are highlighted.NOTE: Use the Outline toggle ② to show/hide the automatic vertebra outlining.

2. Select Next to confirm selection.

3. The software labels the vertebrae by level ③. Check that the labeling in the softwarematches the actual vertebrae level of the patient.• If labeling is correct, select Confirm.• If labeling is incorrect, select Discard. Vertebrae are labeled generically.

Proposed Screws


NOTE: Upon opening the software, the vertebrae are calculated, which may take up to twominutes. Optionally, select Skip to proceed without calculating the vertebrae and plan screwsmanually.

Screw Planning Views

①

②

④

③

Figure 6

No. Component

①

DRR/3D viewSelect the arrows to open view options:• DRR• 3D• AP: Anterior-posterior• Lat (L): Lateral left• Lat (R): Lateral right• Screw: Centered on selected screw

NOTE: Once a view has been manipulated (e.g., with panning or zoom), the viewchanges to Free.

② Inline views

③ Yellow lines identify the current slice in the Cine View.

④ Cine View: Plays through the slices that the screw perpendicularly intersects. Use thebutton to pause or play through the slices, or select a slice using the slider.

NOTE: When scrolling, views are scrolled perpendicular to patient orientation (i.e., not in line withthe planned screw).

SCREW PLANNING


Planning Page Features

① ②

④⑤

⑥

⑦

③

Figure 7

No. Component

① Touch a screw or select a screw from the SCREWS list to activate drag-and-drop han-dles.

② Planned screw Length and Diameter

③ SCREWS list

④ New Screw: Add a manually planned screw.

⑤ Realistic Shape: Toggle on/off to show a realistic screw shape or a simple cylindricalform.

⑥ Diameter and Length adjustment tools

⑦

Virtual Rod: Toggle on/off to show the length measured between the center of thescrew heads.NOTE: It is important to consider that physical rods require additional length at the rodends. Overall rod length can change compared to planning if the intraoperative verte-brae relation differs to the plan (e.g., due changed patient position, decompression oralignment).

NOTE: Virtual Rod length is not available for manually planned screws.

Proposed Screws


How to Plan with Proposed Screws

②

⑥

④

③

①

⑤

Figure 8

Step

1. Based on your target area definition, screws are automatically added to the image set forthoracolumbar vertebrae.Select a screw from the SCREWS list ②.

2. Review the screw Length and Diameter ①.Use the drag-and-drop handles to adjust screw position and/or length.NOTE: Length adjustments using the drag-and-drop handles are made in 5 mm incre-ments.

3. Make any necessary adjustments to Diameter or fine adjustments to Length using thecontrols ④.

4. Optional: Use the Cine View ⑥ to review the trajectory of the planned screw.

5. Optional: Toggle Virtual Rod ⑤ to show/hide the measured distance between the screwhead centers.NOTE: Virtual Rod is only available if at least two screws on the same treatment sidehave been approved.

6. To approve the screw, select the checkbox.A check mark ② appears next to the approved screw in the SCREWS list.NOTE: You can also add screws manually using the New Screw button ③.

SCREW PLANNING


How to Add and Remove Proposed Screws

①②

Figure 9

Step

1. Select the arrows at the top of the SCREWS list.

2. To add a screw, select it from the AVAILABLE SCREWS list using the plus icon ①.The screw is added to the image set and moves to the SCREWS list.NOTE: Optionally, select Back to select additional vertebrae. The software proposesscrews for those selected vertebrae.

3. To remove a screw, select it from the SCREWS list using the minus icon ②.The screw moves back to the AVAILABLE SCREWS list.

Proposed Screws


3.2 Manual Planning Workflow

Manual Screw Planning

Manual screw planning is necessary:• When planning screws in the cervical, sacrum or pelvic area.• In case of target definition failure.• If only MR data is available.

Screws can also be added manually in addition to the screws proposed by the software.Virtual Rod length is not available for manually planned screws.

How to Plan Screws Manually

④

① ③②

⑤

⑥

Figure 10

Step

1. Select New Screw ④.A screw is added parallel to the currently selected screw. If no screw is selected, a screwis added to the center of the inline view.

2. Review the selected screw Length and Diameter ②.Use the drag-and-drop handles ① to adjust screw position and/or length.NOTE: Length adjustments using the drag-and-drop handles are made in 5 mm incre-ments.

3. Make any necessary adjustments to Diameter or fine adjustments to Length using thecontrols ⑥.

4. Repeat manual planning steps for each screw.

5. Optional: Toggle Realistic Shape ⑤ on/off to show a realistic screw shape or a simplecylindrical form.

6. Optional: Select the trash icon ③ to delete the selected screw.

SCREW PLANNING


Manual Planning Workflow


INDEXA

add screws manually..................................................................25approve proposed screws.......................................................... 23automatic screw proposal...........................................................19available screws list....................................................................24

Ccompatible image sets................................................................19compatible spine regions............................................................19

Ddata menu.................................................................................. 16define target area....................................................................... 20delete screws........................................................................ 24,25

Eerror vertebrae definition............................................................ 25

Ffailure of vertebrae definition...................................................... 25

Hhome button............................................................................... 15

Iinline views................................................................................. 21

Llevel definition.............................................................................20loading patient data.................................................................... 16

Mmanual screw planning...............................................................25

Nnaming screw............................................................................. 17

Oobjects........................................................................................ 16open the software.......................................................................13

Ppan............................................................................................. 15plan proposed screws................................................................ 23planning tools............................................................................. 22planning views............................................................................21points..........................................................................................16

Rrealistic shape....................................................................... 22,25remove screws...................................................................... 24,25

Sscrew color................................................................................. 17screw list.....................................................................................24screw name................................................................................ 17scroll........................................................................................... 15select vertebrae..........................................................................20start the software........................................................................13support numbers.......................................................................... 5

Ttarget definition...........................................................................20toggle buttons........................................................................22,25

Vvertebrae of interest................................................................... 20views.......................................................................................... 21virtual rod....................................................................................22

Wwindowing...................................................................................15

Zzoom...........................................................................................15

INDEX


brainlab.com

Art-No. 60920-06EN

*60920-06EN*

TABLE OF CONTENTS1 GENERAL INFORMATION1.1 Contact Data1.2 Legal Information1.3 Symbols1.4 Using the System1.5 Compatibility with Medical Devices and Software1.6 Training and Documentation

2 SPINE PLANNING INTRODUCTION2.1 Getting Started2.2 Toolbar

3 SCREW PLANNING3.1 Proposed Screws3.2 Manual Planning Workflow

INDEX

spine planning 1 · the spine & trauma navigation system enables computer-assisted navigation of...

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