CURVE DUAL NAVIGATION STATION System User Guide Rev 1.2

TABLE OF CONTENTS

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

Symbols ...10 Symbols Used in This Guide ...10 Hardware Symbols...11

Intended Use ...14 Using the System ...14

Training and Documentation ...16 Training ...16 Documentation...17

SYSTEM OVERVIEW ...19 System Components ...19 System Setup ...22 Curve Optical Tracking...22 Curve EM System Setup ...24 OR Setups ...25

Proper System Handling ...27 Inspections ...30 Annual Inspection ...31 Weekly and Monthly Inspections ...32 Safety Inspection ...33

Malfunctions and Return Instructions ...34 Malfunctions...34 Return Instructions ...35

MONITOR CART ...37 Components ...37 Cart Arms and Monitors ...39 Range of Motion...41 Positioning Monitors...44 Locking Monitors...46

Panels and System Ventilation ...47 Back Panels ...47 System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2

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TABLE OF CONTENTS

Sound Panel ...51 System Ventilation ...53 LED Indications...54

Cabling ...55 Cable Connection ...55 Cable Storage ...58

CAMERA CART ...59 Cart Components ...59 Camera Cart ...59 Camera ...61

Cabling ...62 Cable Attachment ...62

Camera Use ...64 Range of Motion...66 Operating Position ...69 Adjusting Camera Position ...70

LEDs and Acoustic Signals ...75

EM TRACKING UNIT ...77 EM Tracking Unit Components ...77 Overview...77

EM Tracking Unit Setup ...79 Overview...79 Setting Up EM Tracking Unit ...80 Connecting EM Tracking Unit to Monitor Cart ...84 Connecting EM Instruments ...86

Using the EM Tracking Unit ...87 Overview...87 Positioning Components ...88 Positioning Patient ...91

LEDs and Acoustic Signals ...93 Overview...93

USING THE SYSTEM ...95 Powering System On ...95 Turning On System ...96

System Shutdown ...97 Sterile Use ...99 Sterile Camera Handle Drape ...99 Sterile Monitor Drape ...101

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TRANSPORT ...105 Locking and Unlocking Brakes ...105 Monitor Cart Brakes ...106 Camera Cart Brakes ...107

Docking Camera and Monitor Carts...108 Before You Begin ...108 Transport and Parking Position ... 111 Docking and Undocking Procedure ...115

Transporting the System ...117 Proper Transport Procedure...119

Parking and Storage ...121 Parking...121 Storage ...122 Transporting the EM Tracking Unit using Transport Cases...123 Long Term Storage ...126

CLEANING ...127 Cleaning Instructions ...127 Curve System ...129 Protection Cover for Monitors...131 Protection Cover for Camera...132 Transport Cases...133

INDEX ...135

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TABLE OF CONTENTS

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System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2

GENERAL INFORMATION

1

GENERAL INFORMATION

1.1

Contact Data and Legal Information

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: +1 800 597 5911 Fax: +1 708 409 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 1044 Fax: +49 89 991568 5811

Japan

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

[email protected]

Expected Service Life Brainlab provides eight years of service for Curve Dual Navigation Station. Brainlab provides a minimum of five years of service for EM Tracking Device. During these periods of time, spare parts as 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 can improve this manual.

Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich 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 • Brainlab® is a registered trademark of Brainlab AG in Germany and/or the US. • Curve ™ is a trademark of Brainlab AG in Germany and/or the US.

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

CE Label The CE label shows that the Brainlab product complies with the essential requirements of Council Directive 93/42/EEC (the "MDD"). According to the principles set out in the MDD, Curve and the EM Tracking Unitare Class IIb products.

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: www.brainlab.com/en/sustainability To arrange the disposal of the UPS battery, please contact Brainlab support.

Registration, Evaluation and Authorization of Chemicals (REACH) REACH is the European chemicals law that came into force to improve the protection of human health and the environment from risks that can be posed by chemicals. The identification of a substance as a substance of very high concern and its inclusion in the candidate list for REACH creates certain legal obligations for the importers, producers and suppliers of an article that contains such a substance. Brainlab requests suppliers to inform whether and to what extent substances from the list are used in their products. For further information regarding REACH processes at Brainlab, contact us here: 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.

Federal Communications Commission (FCC) Statement This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio 8

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GENERAL INFORMATION

communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their expense. Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The WLAN module included in this product cannot be accessed by end users. The FCC ID of the WLAN module is listed on the WLAN label attached to the Monitor Cart. Please contact Brainlab Support in case of any related questions.

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Symbols

1.2

Symbols

1.2.1

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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GENERAL INFORMATION

1.2.2

Hardware Symbols

Symbols on Hardware Components The following symbols may be found on the system: Symbol

Explanation

Class 2 Wireless LAN

AC current

Potential equalization point

IPxy

Ingress Protection according to IEC 60529 X = Protection against ingress of solid objects Y = Protection against ingress of liquid Do not reuse

Do not resterilize

Sterilized with ethylene oxide

Do not use if packaging is damaged

Keep away from sunlight

Keep dry

Quantity of products in packaging

Batch code

Serial Number

Use by month YYYY

Date of manufacture

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Symbols

Symbol

Explanation

Manufacturer

Danger of clamping hand or other body parts in equipment

Do not look directly into the laser beam or point laser beam into the patient’s face or eyes. Laser radiation emitted from aperture Do not stare into beam Class 2 laser product max. output 1mW wavelength 635 nm Radio device

Consult accompanying documentation

When the D and line below it are lined up, the camera is perpendicular to the base of the Camera Cart

Markers on joints to identify the parking position

Marker indicates correct transport position for the height of telescopic post

Only move Camera Cart in transport position

Only move Monitor Cart in transport position

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GENERAL INFORMATION

Symbol

Explanation

Visual hint: how to dock/undock system

Danger of tilting: Do not move system when brakes are locked or if device is blocked by obstacles

Strong magnetic field

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Intended Use

1.3

Intended Use

1.3.1

Using the System

System Use The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating: • A tracking system (optical or electromagnetic) • A computer unit that runs the software • Display units to display the navigation, including touch functionality for the user to interact with the software.

Place of Use The system is only for use indoors, in a hospital operating room.

Patient Population The patient population consists of patients that could be treated via Brainlab application software that are released for this Image Guided Surgery (IGS) device. For details please refer to the relevant Software User Guide.

User Profile The following describes the intended users of the system and their respective tasks: • The clinical team (e.g. nurses) is responsible for transporting the Curve into the OR, setting up and preparation of the system for sterile use prior to surgery with constant control of sterility during surgery as well as shutting down, tidying and storage of the system after surgery. • The clinical team (e.g. surgeons) is responsible for the configuration of the clinical setup and the sterile use of Curve (interaction with Brainlab application Software and Hardware) during image guided surgery. • The cleaner is responsible for cleaning and storage of the device. • The Brainlab medical technician is responsible for installation of the Brainlab device as well as system maintenance, repair and support. • The hospital medical technician is responsible for overseeing electrical safety of installed devices and contacting Brainlab in case of additional support.

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

Frequency of Use The frequency of use is defined is defined according IEC 60601-1-6 to be between once per month and several times per week.

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GENERAL INFORMATION

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

System Maintenance Do not carry out inspections or maintenance while Curve is being used for patient treatment.

Applied Parts Depending on the clinical application software running on Curve, applied parts might be combined with the platform on system level. For details please refer to the Brainlab documentation for that part.

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Training and Documentation

1.4

Training and Documentation

1.4.1

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 critical, perform a sufficient number of complete procedures with a Brainlab representative present 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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1.4.2

Documentation

Intended Audience This user guide intended for surgeons and hospital staff.

Reading User Guides 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 Disregarding information in the user guides, in particular the disregard of warning and cautions, is considered to be abnormal use.

Available User Guides 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 instruments

System User Guides

Comprehensive information on system setup

Technical User Guide

Detailed technical information on the system, including specifications and compliances

NOTE: Not all of the above-mentioned user guides are available or relevant for all Brainlab products. If you have questions regarding the user guides you received, contact Brainlab support.

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Training and Documentation

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SYSTEM OVERVIEW

2

SYSTEM OVERVIEW

2.1

System Components

Terminology The Curve Dual Navigation Station shall be referred to as “Curve system” in this user guide.

Abbreviation UPS is used to abbreviate “uninterruptible power supply” in this manual.

General Information The Curve system is a navigation platform used for image guided surgery, consisting of: • A camera unit (see page 61) • A medical computer unit for running software (see Technical User Guide) • Touchscreen monitor units for displaying navigation and for user interaction with the software (see page 39)

EM Tracking Unit The EM Tracking unit consists of two main components, EM Base Station and EM Field Generator. EM Base Station must be fixed to the OR table. EM Field Generator must be fixed to either the Fixation Plate or the Positioning Arm when in use.

Optical Tracking Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light. • Reflective elements, affixed to reference arrays on the patient and to instrumentation, reflect the infrared signals back to the camera unit. • Reflected signals from the reflective elements are captured and digitized by each camera lens from a different angle. • The software uses the camera input to calculate the relative three-dimensional positions of the instruments and the patient reference arrays.

Basis for Electromagnetic Tracking Electromagnetic (EM) tracking uses a field generator to create a known volume of a varying magnetic field. This field induces voltage into coils located inside the EM instruments. From the strength and phase of the induced voltages, the position of the instrument inside the area of interest is calculated. Brainlab software applications use this tracking unit input to display the three-dimensional position of the EM instruments relative to the EM Patient Reference.

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System Components

System Components

② ③

① ④

⑧

⑤

⑦

⑥

Figure 1

20

No.

Component

See

①

Camera Cart

Page 59

②

Camera

Page 61

System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2

System Setup

2.2

System Setup

Curve Optical Tracking

General Information The Curve system is an optical-tracking, touchscreen-operated planning and navigation system designed for pre- and intraoperative use. • Monitor Cart and Camera Cart are delivered pre-installed and ready for use. • All system components are suitable for continuous use during surgical procedures. • Only use system components indoors, in an operating room.

How to Safely Position the System Steps

See

1.

Remove protection covers from display and camera before entering the OR. Page 108

2.

Move equipment into the OR

Page 119

3.

Angle the system so that: • The Curve logo on the Monitor Cart points toward the patient • User and connection panels and the Camera Cart connector point away from the patient NOTE: Do not position the camera, monitors or any other part of the Curve system directly over the patient.

Page 25

4.

Lock all brakes on the Monitor Cart and Camera Cart.

Page 105

5.

Move monitors into desired position.

Page 44

6.

Lock all locks on the monitor arms.

Page 46

7.

Move camera into desired position.

Page 70

8.

Connect all cables at the connection panel.

Page 48

Ensure that the system is set up so it is not possible for the patient to touch or come in contact with the equipment. Ensure that the system is set up in a way that the mains power plug on the Monitor Cart is easily accessible. In case of malfunction, you must be able to easily unplug the mains power cable.

Sterile Field The Curve system is unsterile. Do not allow the camera, monitors or any other part of the Curve system to enter the sterile field.

Interferences If camera’s infrared light interferes with other devices, reposition these devices and/or the camera so that the interference is resolved. The camera’s infrared light may interfere with other IR-based OR equipment, such as remote controls, pulse oximeters or IR-sensitive microscopes.

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System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2