SPINE AND TRAUMA User Guide Rev 2.0

TABLE OF CONTENTS

TABLE OF CONTENTS GENERAL INFORMATION ...7 Contact Data and Legal Information ...7 Legal Information ...8

Symbols ...9 Hardware Symbols...10

Intended Use ...12 Training and Documentation ...13 Documentation...14

INSTRUMENTATION OVERVIEW ...15 Instrument Handling and Overview ...15 Using Fixation Pins and Schanz Screws ...16 Available Instruments...17

GENERAL INSTRUMENTATION...23 Disposable Reflective Marker Spheres ...23 Using Marker Spheres ...24

Instrument Calibration Matrix (Rev. 4) - ICM4 (41874)...26 Calibration Inserts 3.6 mm and 6.3 mm (53520, 53521)...29 Calibration Insert for Synthes LISS/LCP (53510) ...30 Calibration Inserts for Synthes LFN 9-11 mm (53511) and 12-16 mm (53512) ...32

Patient Scan Drape (22182) ...34 Draping the Patient ...35 Securing the Drape ...41 Removing the Drape ...42

Adhesive Flat Markers Angio (19143) ...43 Adhesive Flat Markers for Scanners (19144) ...44 iCT Scan Drape (22180-23) ...45 Draping CT Scanner with iCT Drape ...46

Calibration Phantom iCT Kit ...50 Verifying the Automatic Image Registration with the Phantom...51

Establishing a Serial Connection ...52

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TABLE OF CONTENTS

POINTERS...53 Using Pointers ...53 Maintaining Pointer Accuracy...54

Types of Pointers ...55 Disposable Clip-on Remote Control (53153) ...56 Attaching the Disposable Clip-on Remote Control ...57 Using the Disposable Clip-on Remote Control ...59 After Use...60 Technical Specifications ...61 Electromagnetic Compatibility and Emissions ...63 Electromagnetic Immunity ...64 RF Communications Equipment...66

REFERENCE ARRAYS ...67 General Array Handling ...67 MI Reference Arrays, X-Press ...69 MI Reference Array, X-Press Kits...70 Bone Fixators, X-Press ...71 Using Schanz Screws with Bone Fixators ...72 Bone Fixator “1-Pin”, X-Press ...74 Bone Fixator “2-Pin”, X-Press ...77 Using the Drill Template (Optional)...78 Attaching the Bone Fixator “2-Pin”, X-Press ...79 Reference Array Assembly...81 Attaching and Detaching the Reference Array...82 Preparation for Registration ...84

Spine Reference Kit - Anterior/Lateral/Oblique (55070)...86 Inserting Fixation Pin...87 Attaching the Connector Tube...89 Attaching the Reference Array Unit ...90

Spine Reference X-Clamp ...92 Attaching and Using the Spine Reference X-Clamp ...93 Detaching Spine Reference X-Clamp...96

Radiolucent Spine Reference Clamp (55756) ...97 Attaching, Detaching and Using the Clamp ...99

Skull Reference Set ...102 Self-Drilling Screws and Screwdriver ...104 Using the Skull Reference Set ...105 Attaching the Skull Reference Base to the Skull...106 Preparation for Registration and Navigation ...108 Removing the Skull Reference Set...110

Reference Headband (41878) with Reference Headband Array (41877) ... 111 Attaching the Reference Headband and Array ...112

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INSTRUMENT ADAPTERS ...113 Using Adapters ...113 Adapter for Surgical Motor System (41840) ...115 Attaching Adapter for Surgical Motor System ...116

Instrument Adapter Kit, StarLink Interface...117 Assembling Instrument Adapter Array ...118 Attaching Adapter to the Instrument ...119

Instrument Adapter, StarLock Interface (55080, 55085)...120 Attaching the StarLock ...121

Reference Array for Trauma Implants (53500) ...122

SPINE IGS INSTRUMENTS ...125 Spine IGS Instrument Set ...125 Instrument Tips ...126 IGS Tool Star Units and Handles ...128 Attachment...130

Instrument Verification and Validation ...131 Pedicle Access Needle ...132

DRILL GUIDE ...135 Assembly ...135 Assembling the Drill Guide ...137

Accessories ...138 Depth Control...139 Drill Guide Trocar Insert ...141

Drill Guide Kit - Trocar and Tissue Protection Sleeve ...143 Verification and Validation ...145 Optional Calibration of the Drill Depth ...147

Navigation ...148 Navigating with the Trocar Tube and Tissue Protection Sleeve ...149

FLUORO REGISTRATION KITS ...151 Fluoro Registration Kits - General Handling ...151 Fluoro 3D/2D Registration Kit (55720) ...153 Inserting Reflective Disks (55775)...155 Attaching and Securing Fluoro 3D/2D Registration Kit ...157 Using a Laser Targeting Device for Siemens C-arms ...159 Instrument User Guide Rev. 2.9 Spine and Trauma

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Using 2D Registration Ring ...161 Draping the Fluoro 3D/2D Registration Kit ...163

Fluoro Registration Kit (Rev. 2) (55705) ...165 Inserting Reflective Disks (55775)...166 Attaching Fluoro Registration Kit (Rev. 2) ...168 Attaching Removable Calibration Plate ...169 Fluoro Registration Kit (Rev. 2) C-Arm Drape (55706) ...171

Fluoro Registration Kit (Rev. 1) (41705) ...176 Inserting Reflective Disks (Fluoro Registration Kit, Rev. 1) (41775)...177 Attaching Fluoro Registration Kit (Rev. 1)...179

Fluoro Registration Kit for Ziehm Vision FD Vario 3D C-arm (55730) ...180 xSpot (55741) ...183 xSpot Accessories ...184 Using xSpot ...187

INDEX ...189

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Instrument User Guide Rev. 2.9 Spine and Trauma

GENERAL INFORMATION

1

GENERAL INFORMATION

1.1

Contact Data and Legal Information

Contact Data

Support If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region

Telephone and Fax

Email

United States, Canada, Central and South America

Tel: (800) 597-5911 Fax: (708) 409-1619

[email protected]

Brazil

Tel: (0800) 892-1217

UK

Tel: +44 1223 755 333

Spain

Tel: +34 (900) 649 115

France and French-speaking regions

Tel: +33 800 676 030

Africa, Asia, Australia, Europe

Tel: +49 89 991568-44 Fax: +49 89 991568-811

Japan

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

[email protected]

Expected Service Life Unless specifically stated otherwise, there is no defined service life for instruments. The end of service life depends on wear and damage during use. Repeated reprocessing has minimal effect on the service life time.

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

Manufacturer Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany

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Contact Data and Legal Information

1.1.1

Legal Information

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

Brainlab Trademarks StarLink® is a registered trademark of Brainlab in Germany and/or the US.

CE Label • The CE label shows that the Brainlab product complies with the essential requirements of the Medical Device Directive (MDD). • According to MDD, Council Device Directive 93/42/EEC, the classification of the Brainlab product is defined in the corresponding Software User Guide. 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 regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: http://www.brainlab.com/weee

Sales in the US US federal law restricts these devices to sale by or on the order of a physician.

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GENERAL INFORMATION

1.2

Symbols

Symbols Used in This Guide

Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse.

Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding 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.

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Symbols

1.2.1

Hardware Symbols

Symbols on Hardware Components Symbol

Explanation Type B Applied Part according to IEC 60601-1

Type BF Applied Part according to IEC 60601-1

Attention! Consult accompanying documents

Potential equalization point

MR Safe

MR Unsafe

MR Conditional: The number shown on each label specifies the MR environment in which the device can be used with caution

Do not reuse

Non-Sterile

Do not resterilize

Sterilized with ethylene oxide

Do not use if packaging is damaged

Keep away from sunlight

Keep dry

Storage conditions for relative humidity non-condensing: The specified humidity range is shown on each label

Storage conditions for air pressure: The specified air pressure range is shown on each label

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GENERAL INFORMATION

Symbol

Explanation Storage conditions for temperature: The specified temperature range is shown on each label

Quantity of products in packaging

Batch number

Serial number

Article number

Expiration date. Do not use after this date.

Date of manufacture

Manufacturer

Authorized representative in the European Community

IPXY

Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects • Y = Protection against ingress of liquid On/off switch

Standby switch to bring the device into standby mode

Direct current Acoustic power output of integrated ultrasound probes complies with FDA Track 3 and IEC 60601-2-37

Consult the operating instructions

Follow the instructions for use

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Intended Use

1.3

Intended Use

Hardware Handling

Place of Use The medical devices in this user guide are to be used in the operating room.

Careful Hardware Handling System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully. Only trained medical personnel may operate system components and accessory instrumentation.

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GENERAL INFORMATION

1.4

Training and Documentation

Training

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

Supervised Support Before using the system for surgical procedures where computer-aided navigation is considered essential: • Simulate a sufficient number of complete procedures on sawbones and/or cadavers. • Use the system in operations where computed-aided navigation may be desirable but not essential. A Brainlab representative must be present at such operations to provide guidance where necessary.

Responsibility This system solely provides assistance to the surgeon and does not substitute or replace the surgeon’s experience and/or responsibility during its use.

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Training and Documentation

1.4.1

Documentation

Intended Audience This user guide is intended for surgeons and their staff.

Reading User Guides The user guides describe complex medical devices and surgical navigation software that must be used with care. It is important that all users of system, instruments and software: • Read the user guides carefully before handling the equipment • Have access to the user guides at all times

Available User Guides

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User Guide

Contents

Software User Guides

• Overview of treatment planning and image-guided navigation • Description of OR system setup • Detailed software instructions

Instrument User Guides

Detailed instructions on instrument handling

Cleaning, Disinfection and Sterilization Guide

Details on cleaning, disinfecting and sterilizing instrumentation

System User Guides

Comprehensive information on system setup

Technical User Guide

Detailed technical information on the system, including specifications and compliances

Instrument User Guide Rev. 2.9 Spine and Trauma

INSTRUMENTATION OVERVIEW

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INSTRUMENTATION OVERVIEW

2.1

Instrument Handling and Overview

Safety Critical Information

Correct Handling The instruments described in this manual are highly accurate and sensitive medical devices and must be handled with extreme care. If you drop or otherwise damage an instrument, return it immediately to Brainlab for testing. Failure to do so may lead to serious injury to the patient. Do not use damaged or corroded instruments.

If you suspect an instrument is inaccurate, verify and validate it again, or return it to Brainlab for testing.

Creutzfeldt-Jakob Contamination Do not use Brainlab instrumentation on patients suspected of having Creutzfeldt-Jakob disease (CJD or vCJD).

MR Safety Unless otherwise noted, the instruments are MR unsafe.

Sterilization Unless otherwise indicated, instruments must be sterilized before use. Details are provided in the Cleaning, Disinfection and Sterilization Guide. If a sterile instrument is inadvertently removed from the sterile field, it must be sterilized again.

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Instrument Handling and Overview

2.1.1

Using Fixation Pins and Schanz Screws

General Information The placement of a fixation pin in bone structures is a standard minimally invasive and low-risk surgical procedure that is required in order to provide a stable basis for attaching reference arrays and performing navigation. However, as an incision is required, read the following information carefully.

Risks Because fixation pin placement requires an incision, one or more of the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, bone fracture or thrombosis. Placement of a fixation pin in the acetabulum may cause lesions of the viscera. Avoid multiple drilling attempts as this may weaken the bone and increases the risk of post-operative stress fractures. Stop drilling once the opposite corticalis has been reached.

Precautions If you use an automatic drill to place a fixation pin, use only the lowest drilling speed to maintain maximum control over the drilling depth. Do not bend the fixation pin during the drilling procedure. Use only a threaded fixation pin with the specified diameter. Using a fixation pin with the incorrect diameter could result in unstable attachment. To ensure stable attachment, position fixation pins bicordically where possible.

Disposable Items Schanz screws are disposable items. Dispose of them after use.

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INSTRUMENTATION OVERVIEW

2.1.2

Available Instruments

General Instrumentation Illustration

Instrument User Guide Rev. 2.9 Spine and Trauma

Component

See

Disposable Reflective Marker Spheres

Page 23

Instrument Calibration Matrix (Rev. 4) - ICM4

Page 26

Patient Scan Drape

Page 34

Adhesive Flat Markers Angio

Page 43

Adhesive Flat Markers for Scanners

Page 44

iCT Scan Drape

Page 45

Calibration Phantom iCT Kit

Page 50

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Instrument Handling and Overview

Pointers Illustration

Component

See

Pointer with Sharp Tip

Page 55

Pointer Extended with Sharp Tip

Page 55

Disposable Clip-on Remote Control

Page 56

Component

See

MI Reference Array, X-Press

Page 69

Component

See

Spine Reference Kit Anterior/Lateral/Oblique

Page 86

General Reference Array Illustration

Spine Reference Arrays with Fixation Pins Illustration

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INSTRUMENTATION OVERVIEW

Spine Reference Clamps Illustration

Component

See

Spine Reference X-Clamp

Page 92

Radiolucent Spine Reference Clamp

Page 97

Component

See

Skull Reference Set

Page 102

Skull Reference Set Illustration

Reference Headband with Reference Headband Array Illustration

Instrument User Guide Rev. 2.9 Spine and Trauma

Component

See

Reference Headband with Reference Headband Array

Page 111

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Instrument Handling and Overview

Instrument Adapters Illustration

Component

See

Adapter for Surgical Motor System

Page 115

Instrument Adapter Kit, StarLink Interface

Page 117

Instrument Adapter, StarLock Interface

Page 120

Reference Array for Trauma Implants

Page 122

Component

See

Spine IGS Instrument Set

Page 125

Drill Guide and Accessories

Page 135

Spinal Instrumentation Illustration

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INSTRUMENTATION OVERVIEW

Illustration

Component

See

Pedicle Access Needle

Page 132

Component

See

Fluoro 3D/2D Registration Kit

Page 153

Fluoro Registration Kit (Rev. 2)

Page 165

Fluoro Registration Kit (Rev. 1)

Page 176

Fluoro Registration Kit for Ziehm Vision FD Vario 3D C-arm

Page 180

xSpot

Page 183

Fluoro Registration Kits Illustration

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