UPDATE STRUCTURE OPERATIVE INTRA- · Pre-Operative Steps Using Smartbrush Use Smartbrush to segment objects of interest in data sets. For more information, see the Software User Guide

INTRA-OPERATIVESTRUCTUREUPDATEVersion 1.0

Software User GuideRevision 1.1Copyright 2018, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTSGENERAL INFORMATION ...................................................................................................5

Contact Data................................................................................................................................................5Legal Information .........................................................................................................................................6

Safety Notices.............................................................................................................................................7

Intended Use ...............................................................................................................................................8

Compatibility with Medical Devices .......................................................................................................9

Training and Documentation .................................................................................................................10

SOFTWARE OVERVIEW......................................................................................................11

Introduction ...............................................................................................................................................11

Loading Patient Data ...............................................................................................................................12

Beginning a Session ...............................................................................................................................14

Instrument Calibration and Verification ..............................................................................................15

Using Intraoperative Structure Update ...............................................................................................17Surface Acquisition ....................................................................................................................................19Surface Shaping ........................................................................................................................................21

Viewing Objects........................................................................................................................................22

Saving Data, Closing and Exiting the Software.................................................................................24

INDEX ....................................................................................................................................................25

TABLE OF CONTENTS

Software User Guide Rev. 1.1 Intraoperative Structure Update Ver. 1.0 3

TABLE OF CONTENTS

4 Software User Guide Rev. 1.1 Intraoperative Structure Update 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, Central andSouth America

Tel: +1 800 597 5911Fax: +1 708 409 1619 [email protected]

Brazil Tel: (0800) 892-1217

UK Tel: +44 1223 755 333

[email protected]

Spain Tel: +34 (900) 649 115

France and French-speaking regions 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 five years of service for software. During this period of time, software updatesas well as field support are offered.

Feedback

Despite careful review, this manual may contain errors.Please contact us at [email protected] if you have suggestions as to how we canimprove it.

Manufacturer

Brainlab AGOlof-Palme-Str. 981829 MunichGermany

GENERAL INFORMATION


1.1.1 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 registered trademark of Brainlab AG in Germany and/or the US.

Non-Brainlab Trademarks

Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the United Statesand other countries.

Integrated 3rd-Party Software

This software is based in part on the work of the Independent JPEG Group.This software is based in part on iTextSharp by Bruno Lowagie and Paulo Soares.Intraoperative Structure Update is proprietary software. The Intraoperative Structure Updatesoftware is protected by copyright. In addition to the Intraoperative Structure Update software,other software applications may also be installed on the Intraoperative Structure Updateworkstation that are licensed under the GNU General Public License. The proprietary softwareand the free software are used in compliance with the "mere aggregation" clause defined by theGNU GPL. The full terms and conditions of the GNU General Public License can be found here:http://www.gnu.org/licenses/gpl-2.0.html

Patent Information

This product may be covered by one or more patents or pending patent applications. See https://www.brainlab.com/patent for more details.

CE Label

• The CE label indicates that the Brainlab product complies with the essential re-quirements of European Council Directive 93/42/EEC, the Medical Device Di-rective (“MDD”).

• According to the rules established by the MDD, Cranial is a Class IIb product.

NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.

Disposal Instructions

Only dispose of electrical and electronic equipment in accordance with statutory regu-lations. For information regarding the WEEE (Waste Electrical and Electronic Equip-ment) directive, visit:http://www.brainlab.com/en/sustainability

Sales in the US

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

Contact Data


1.2 Safety Notices

Warnings

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

Cautions

Cautions are indicated by circular caution symbols. They contain safety-critical informationregarding possible problems with the device. Such problems include device malfunctions,device failure, damage to device or damage to property.

Notes

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

GENERAL INFORMATION


1.3 Intended Use

Indications for Use

The indications for use are defined in the Software User Guide of the IGS system that is usingIntraoperative Structure Update e.g., Cranial.

Plausibility Review

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

Responsibility

This application solely provides additional assistance to the surgeon or user and does notby any means substitute or replace the surgeon’s or user’s experience and/orresponsibility during its use.

Medical Electrical Systems

For information regarding the configuration of medical electrical systems, see the relevant SystemUser Guide and Technical User Guide.

Instrument Contact with Brain Tissue and Spinal Fluid

Only use instruments intended for direct contact with brain tissue and spinal fluid.

Intended Use


1.4 Compatibility with Medical Devices

Compatible Brainlab Medical Software

Intraoperative Structure Update 1.0 is compatible with:• Content Manager 2.0• DICOM Viewer 2.0• Patient Browser 4.0• DICOM Proxy 3.2• Image Fusion 1.0• Smartbrush 2.0

Other Brainlab Software

Other compatible Brainlab software may become available after the release of this user guide. Ifyou have questions regarding compatibility of the software contact Brainlab support.If you are currently running software versions other than those specified above, contact Brainlabsupport for clarification regarding compatibility.

Only Brainlab medical software specified by Brainlab may be installed and used with thesystem.

Virus Scanning and Malware

Be aware that some malware protection software (e.g., virus scanner) settings cannegatively affect system performance. For example, if real-time scans are performed andeach file access is monitored, then loading and saving patient data may be slow. Brainlabrecommends disabling real-time scans and to perform virus scans during non-clinicalhours.

Ensure that your anti-virus software does not modify any Brainlab directories.

Do not download or install updates during treatment planning. Contact Brainlab supportfor further information.

GENERAL INFORMATION


1.5 Training and Documentation

Brainlab Training

To ensure safe and appropriate use, before using the system all users should participate in atraining program held by a Brainlab representative.

Documentation

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

Training and Documentation


2 SOFTWARE OVERVIEW2.1 Introduction

General Information

Intraoperative Structure Update supports the modification of an object (e.g., a tumor), using anavigated instrument. The software renders the remaining area into a 3D object.NOTE: Intraoperative Structure Update assumes the calculated object has not moved and thatit is smaller than the original. It cannot add additional volume to the original object.

Pre-Operative Steps Using Smartbrush

Use Smartbrush to segment objects of interest in data sets. For more information, see theSoftware User Guide for Smartbrush.

A Typical Workflow

Steps

1. Select your patient.

2.Select a pre-existing object (e.g.,a Smartbrush object).NOTE: For more information, see the Software User Guide for Smartbrush.

3.Start Cranial and register your patient.NOTE: For more information, see the Software User Guide for Cranial ENT.

4.

Calibrate a suitable instrument within the Cranial environment, ready for use with Intrao-perative Structure Update.Ensure the instrument axis is calibrated using the ICM4 e.g., either via V-inset (notch) orhole calibration.

5. Start Intraoperative Structure Update.

6. Navigate the resection cavity by moving the calibrated instrument along the resection cav-ity (see page 19).

7. Finalize the object.

8. Verify the new object.

9. Select Done.

SOFTWARE OVERVIEW


2.2 Loading Patient Data

How to Load Patient Data

①

Figure 1

Steps

1. Select the patient in the menu bar ① to open Patient Browser.

2. Choose a patient in Patient Browser.

3. Press Select.

NOTE: For further information see the Software User Guide for Content Manager, PatientBrowser and DICOM Viewer.

Loading Patient Data


How to Select Patient Data

①

Figure 2

Steps

1. Select your pre-existing object from your patient data set.

2. Remove any unwanted image data by selecting X ①.

3. Select OK.

NOTE: For further information see the Software User Guide for Content Manager, PatientBrowser and DICOM Viewer.

SOFTWARE OVERVIEW


2.3 Beginning a Session

General Information

Intraoperative Structure Update works in conjunction with Cranial software.Use Cranial to register your patient. For further information see the Software User Guide,Cranial ENT.

Using Brainlab Elements

Content Manager displays an overview of installed Brainlab Elements.Before or after using Intraoperative Structure Update, you can use other Elements e.g.,Smartbrush or Adaptive Hybrid Surgery Analysis (subject to installation and licensing).For further information see the Software User Guide for Smartbrush and Software User Guidefor Adaptive Hybrid Surgery Analysis.

Start Cranial Software

①

Figure 3 Open Cranial from Content Manager in your chosen workflow.

Step

Select the Cranial application ①.The software loads and the main screen opens.

Register Patient Using Cranial Software

Before proceeding with Intraoperative Structure Update you must first register your patientusing Cranial.

Beginning a Session


2.4 Instrument Calibration and Verification

Calibrating the Instrument Axis

Before proceeding with Intraoperative Structure Update, calibrate an instrument using Cranial.

Figure 4

Use the ICM4 (receptacle or hole, notch or v-inset) to correctly calibrate the axis.

To prevent errors due to incorrect instrument handling, make sure to verify the calibrationaccuracy of the instrument tip, axis, and diameter. Perform verification after calibrating aninstrument, loading a precalibration, or restoring a calibration.For more information see the Software User Guide, Cranial ENT.

Recalibration Prompt

Figure 5 You are prompted to recalibrate your instrument using Holes or Notch when the instrument axis ismissing. You must use Cranial Software to recalibrate your instrument.

SOFTWARE OVERVIEW


Instrument Verification

Use the cone of the reference array to verify the accuracy of the instruments.

Instrument Calibration and Verification


2.5 Using Intraoperative Structure Update

How to Start Intraoperative Structure Update

Step

Select Intraoperative Structure Update from Content Manager.

Example View

① ② ③ ④ ⑤

Figure 6

No. Component

① Object information

② Original object prior to resection

③ Navigated instrument

④ Trajectory path of the navigated instrument

⑤ Indicates reference array visibility status

Menu Functions

Button Function

Zoom: to region of interest.

SOFTWARE OVERVIEW


Button Function

Surface acquisition is switched on.

Surface acquisition is switched off.

Start: starts surface acquisition.

Stop: stops or halts surface acquisition.

Reset: Resets or restores the last saved object.”.

Camera Status Bars

Icon Reference Array Visibility

Visible

Not visible

Camera not connected

Camera warming up

Using Intraoperative Structure Update


2.5.1 Surface Acquisition

How to Acquire the Resection Cavity

Steps

1.Ensure instruments are calibrated for use using Cranial.For further information, see Cranial ENT Software User Guide.

2. Move your instrument into position, ensuring it is in the camera’s field of view.

3.Press Start to acquire the resection cavity.Surface Acquisition ON is displayed.

4.

Gently move the calibrated instrument along the resection cavity, marking all points thatindicate the resection cavity.

NOTE: An audible tone sounds during acquisition. The tone changes when enough pointsare taken. No sound is heard if the navigated instrument is taken outside the pre-plannedobject.

5.Press Stop when complete.Alternatively, press Stop to temporarily halt point acquisition, if needed.

6.Intraoperative Structure Update calculates the residual area, creating a new object.NOTE: The 2D views update during acquisition and the 3D view updates after acquisition.

7. Verify the calculated surface of the new Intraoperative Structure Update object.

8.If needed, use Reset to discard your calculated surface.Alternatively, press Start again (see step 3), to continue further point ac-quisition.

9.

Select Done when complete.A new object is saved in Patient Browser, with the following format:Original name + the residual volume. E.g., “tumor 75%”.The new object is available for use in other applications e.g., Cranial navigational use. Ifneeded, the original object can be reselected from Patient Browser.NOTE: Always select Done to save updated objects for later use in other applications orto export. Pressing the Home button does not save or create new objects.

The optical Standard Pointer is not suitable for resection cavity acquisition.

Only modify structures that have not changed shape or position in the currently navigatedimage set, e.g., due to brain shift.

Brain shift may cause a discrepancy between preoperative patient data and the actualposition.

Verify the surface of the voxel object carefully after point acquisition.

SOFTWARE OVERVIEW


How to Verify the Calculated Surface Accuracy

Step

Hold the instrument to landmarks within the resection cavity and verify that the position of theinstrument displayed in the image views corresponds with the actual point on the patient's anato-my.NOTE: If inaccuracies exist, re-acquire the surface or add additional points.

Navigation Accuracy

The navigation and registration accuracies directly influence the accuracy of the residualobject.

Resection Results

② ③ ⑤④

①

⑥

Figure 7 The object information in the 3D view displays the object’s values, before and after resection. Theoutlines of both objects are visible in all views ⑥.

No. Explanation

① Percentage of original object

② Original object volume

③ Object name

④ Residual volume

⑤ Percentage remaining of original object

⑥ Outline of original object

Using Intraoperative Structure Update


2.5.2 Surface Shaping

General Information

Some objects provide limitations for the software in successfully and accurately calculating thesurface.Only smooth organic shapes are processed by the algorithm. Sharp, pointed shapes are notsuitable and give inaccurate results.

Shape Compatibility Overview

The table below shows how different shapes are supported by the application:

Surface Shape Type Example Supported?

Concave Supported

Slightly convex Supported

Deeply convex Supported with limitations

Acute edgesNot supportedErrors may occur aroundthe highlighted areas

SOFTWARE OVERVIEW


2.6 Viewing Objects

How to View Object Information

Step

Click the folder icon to display the SELECTED DATA view.

Auto Selection of Objects within Tumor Workflow

To ensure acquisition starts immediately, Intraoperative Structure Update by default, choosesobjects with an object type of either:• Tumor or;• Unknown

Figure 8 If the object type is Unknown, the software automatically prompts you to save it as Tumor in orderto continue after pressing Done.

Example View

① ② ③ ⑤ ⑧⑥⑦④

Figure 9

Viewing Objects


View your resection object and/or other existing objects in the SELECTED DATA view.

No. Explanation

① Object information

② Resection object

③ Toggle switch for selecting/deselecting individual objects

④ Current image set

⑤ Object selection list

⑥ Toggle switch for selecting/deselecting all objects

⑦ Indicates currently selected resection object

⑧ Toggle layout view on/off

SOFTWARE OVERVIEW


2.7 Saving Data, Closing and Exiting the Software

Saving, Closing and Exiting Intraoperative Structure Update

Button Explanation

Returns you to the previous step.

Select Done to perform the following:• Save your existing task/object• Close Intraoperative Structure Update• Open another application

Pressing the Home button returns you to Content Manager without saving opentasks.

Select Exit from the main screen of Content Manager to start a new treatment orshut down the system.

Saving Data, Closing and Exiting the Software


INDEXA

auto selection............................................................................. 22

Ccamera status.............................................................................18contact with brain tissue and spinal fluid...................................... 8

Ddisposal instructions..................................................................... 6

Eexit..............................................................................................24

Hhome button............................................................................... 24how to.........................................................................................14

close intraoperative structure update..................................... 24open intraoperative structure update......................................17

Iinstrument

calibration using ICM4............................................................ 15recalibration............................................................................ 16selection................................................................................. 19verification.............................................................................. 16

instrument contactbrain tissue and spinal fluid...................................................... 8

intraoperative structure updategeneral information................................................................. 11how to close............................................................................24how to open............................................................................17views.......................................................................................22workflow..................................................................................11

Lloading patient data.................................................................... 13

Nnavigation accuracy....................................................................20

Oobject information....................................................................... 22object naming convention...........................................................19open Cranial............................................................................... 14optimal object shaping................................................................21

Ppatient data.................................................................................13pointer selection......................................................................... 19

Rremove patient data....................................................................13resection results......................................................................... 20reset........................................................................................... 18

Ssaving new object.......................................................................19select patient data...................................................................... 13shape compatibility.....................................................................21start............................................................................................ 18stop.............................................................................................18support......................................................................................... 5surface accuracy........................................................................ 20surface acquisition......................................................................19surface acquisition on/off............................................................18

Uusing brainlab elements............................................................. 14using Smartbrush....................................................................... 11

Vverification.................................................................................. 16views

image overview.......................................................................22

Zzoom...........................................................................................17

INDEX


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Documents

UPDATE STRUCTURE OPERATIVE INTRA- · Pre-Operative Steps Using Smartbrush Use Smartbrush to segment objects of interest in data sets. For more information, see the Software User Guide