User Guide
130 Pages
Preview
Page 1
CURVE DUAL DISPLAY CURVE SINGLE DISPLAY Version 1.0
System User Guide Revision 1.0 Copyright 2011, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS GENERAL INFORMATION... 7 Chapter Overview... 7 Contents... 7
Contact Data and Legal Information... 8 Contact Data... 8 Legal Information... 9
Symbols... 10 Symbols Used in This Guide... 10
Intended Use... 11 Using the System... 11
Training and Documentation... 14 Training... 14 Documentation... 15
SYSTEM OVERVIEW... 17 Chapter Overview... 17 Contents... 17
System Components... 18 Overview... 18
System Setup... 21 Overview... 21 OR Setups... 23
Proper System Handling... 26 Overview... 26
Inspections... 29 Overview... 29 Annual Inspection... 30 Weekly and Monthly Inspections... 31 Safety Inspection... 32
Malfunctions and Return Instructions... 33 Malfunctions... 33 Return Instructions... 34
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TABLE OF CONTENTS
MONITOR CART... 35 Chapter Overview... 35 Contents... 35
Components... 36 Overview... 36
Cart Arms and Monitors... 38 Overview... 38 Range of Motion... 41 Positioning Monitors... 44 Locking Monitors... 46
Panels and System Ventilation... 47 Back Panels... 47 Sound Panel... 53 System Ventilation... 55 LED Indications... 56
Cabling... 57 Cable Connection... 57 Cable Storage... 60
CAMERA CART... 61 Chapter Overview... 61 Contents... 61
Cart Components... 62 Camera Cart - Curve Dual Display... 62 Camera Cart - Curve Single Display... 64 Camera... 66
Cabling... 67 Cable Attachment... 67 Wireless Camera Communication... 69
Camera Use... 71 Overview... 71 Range of Motion... 73 Operating Position... 76 Adjusting Camera Position... 77
LEDs and Acoustic Signals... 85 Overview... 85
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TABLE OF CONTENTS
USING THE SYSTEM... 87 Chapter Overview... 87 Contents... 87
Powering System On... 88 Overview... 88 Turning On System... 89
System Shutdown... 90 Overview... 90
Sterile Use... 92 Sterile Camera Handle Sleeve... 92 Sterile Touchscreen Use... 94
TRANSPORT... 97 Chapter Overview... 97 Contents... 97
Locking and Unlocking Brakes... 98 Overview... 98 Monitor Cart Brakes... 99 Camera Cart Brakes... 100
Docking Camera and Monitor Carts... 101 Before You Begin... 101 Transport and Parking Position... 104 Docking and Undocking Procedure... 110
Transporting the System... 112 Overview... 112 Proper Transport Procedure... 114
Parking and Storage... 116 Parking... 116 Storage... 117 Long Term Storage... 118
CLEANING... 119 Chapter Overview... 119 Contents... 119
Cleaning Instructions... 120 Overview... 120 Curve System... 122 Protection Cover for Monitors... 124 Protection Cover for Camera... 125 System User Guide Rev. 1.0 Curve Dual Display, Curve Single Display Ver. 1.0
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TABLE OF CONTENTS
INDEX... 127
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System User Guide Rev. 1.0 Curve Dual Display, Curve Single Display Ver. 1.0
GENERAL INFORMATION
1
GENERAL INFORMATION
1.1
Chapter Overview
1.1.1
Contents
Topics Covered Section
See
Contact Data and Legal Information
Page 8
Symbols
Page 10
Intended Use
Page 11
Training and Documentation
Page 14
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Contact Data and Legal Information
1.2
Contact Data and Legal Information
1.2.1
Contact Data
Support
Feedback
If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region
Telephone and Fax
United States and Canada
Tel: (800) 597-5911 Fax: (708) 409-1619
Africa, Asia, Australia, Europe
Tel: +49 89 991568-44 Fax: +49 89 991568 5811
Latin America
Tel: +55 11 33 55 33 70 Fax: +55 11 33 55 33 79
Japan
Tel: +81-3-3769-6900 Fax: +81-3-3769-6901
France and French-speaking regions
Tel: +33-800-67-60-30
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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GENERAL INFORMATION
1.2.2
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
Curve™ is a trademark application of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
iPod touch® and iPhone® are trademarks of Apple Inc., registered in the US and other countries.
CE Label • The CE label shows that the Brainlab product complies with the essential requirements of Medical Device Directive (MDD). • According to MDD, Council Device Directive 93/42/EEC, classification of the Brainlab product is defined in the corresponding Software User Guide. 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 To arrange the disposal of the UPS battery, please contact Brainlab support.
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
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Symbols
1.3
Symbols
1.3.1
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
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NOTE: Notes are formatted in italic type and indicate additional useful hints.
System User Guide Rev. 1.0 Curve Dual Display, Curve Single Display Ver. 1.0
GENERAL INFORMATION
1.4
Intended Use
1.4.1
Using the System
System Use
The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating: • An optical tracking system • A computer unit that runs the software • Display unit(s) 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: • Trained hospital personnel (e.g., nurses) are responsible for setting up the system before the surgical procedure and for removing the system after the surgical procedure. - System setup and removal includes: moving and positioning, plugging cables in/out, startup/ shutdown, cleaning of the system, connecting/disconnecting 3rd party devices. • Sterile nurse is responsible for maintaining sterility during surgery, including the draping of devices. • Surgeons and/or surgical assistants steer and interact with the Brainlab software running on the system using the system touchscreen(s). For detailed information on use of the software, see the relevant Software User Guide. • Brainlab personnel are responsible for system maintenance (see page 29) and support (see page 8).
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. Frequency of Use
The frequency of use is defined to be between once per month and several times per week.
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Intended Use
Symbols on Hardware Components
The following symbols may be found on the system: Symbol
Explanation Potential equalization point
IP20
IP Classification 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
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
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GENERAL INFORMATION
Symbol
Explanation 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 (Camera Cart - Curve Dual Display only)
Only move Camera Cart in transport position
Only move Monitor Cart in transport position
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
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from the system.
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Training and Documentation
1.5
Training and Documentation
1.5.1
Training
Brainlab Training
When using the navigation system for the first time, a Brainlab representative should be present for guidance. Start with procedures of low complexity, where you can easily verify how a navigation system will assist you and where limitations are. Simulate procedures on cadavers and/or phantoms before using the system with a patient.
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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GENERAL INFORMATION
1.5.2
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: Available user guides vary depending on the Brainlab product. If you have questions regarding the user guides you received, contact Brainlab support. Quick Reference Guides
Quick Reference Guides are available for most software applications and for some complex instruments. They provide condensed information on using the software or hardware, and are intended to supplement the user guides. NOTE: Quick Reference Guides do not replace the user guides.
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Training and Documentation
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SYSTEM OVERVIEW
2
SYSTEM OVERVIEW
2.1
Chapter Overview
2.1.1
Contents
Topics Covered Section
See
System Components
Page 18
System Setup
Page 21
Proper System Handling
Page 26
Inspections
Page 29
Malfunctions and Return Instructions
Page 33
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System Components
2.2
System Components
2.2.1
Overview
Terminology
Unless otherwise specified, both the Curve Dual Display and Curve Single Display shall be referred to as “Curve system” in this user guide. Similarly, unless otherwise specified, the carts for both the Curve Dual Display and Curve Single Display shall be referred to as “Monitor Cart” and “Camera Cart” 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:
Optical Tracking
Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light.
• A camera unit (see page 66) • A medical computer unit for running software (see Technical User Guide) • Touchscreen monitor unit(s) for displaying navigation and for user interaction with the software (see page 38)
• 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.
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SYSTEM OVERVIEW
Components Curve Dual Display
s
d
a
f
Figure 1
No.
Component
See
a
Camera Cart - Curve Dual Display
Page 62
s
Camera
Page 66
d
26” touchscreens
Page 38
f
Monitor Cart - Curve Dual Display
Page 36
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System Components
Components Curve Single Display
s
d
a
f
Figure 2
20
No.
Component
See
a
Camera Cart - Curve Single Display
Page 62
s
Camera
Page 66
d
26” touchscreen
Page 38
f
Monitor Cart - Curve Single Display
Page 36
System User Guide Rev. 1.0 Curve Dual Display, Curve Single Display Ver. 1.0
SYSTEM OVERVIEW
2.3
System Setup
2.3.1
Overview
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 before entering the OR.
Page 101
2.
Move equipment into the OR
Page 114
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
Page 23
NOTE: Do not position the camera, monitors or any other part of the Curve system directly over the patient. 4.
Lock all brakes on the Monitor Cart and Camera Cart.
Page 98
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 77
8.
Connect all cables at the connection panel.
Page 50
Ensure that the system is set up so it is not possible for the patient to touch or come in contact with the equipment.
As the Camera Carts do not offer a mains power switch, 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 Camera Cart 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. Setup for Wireless Communication
In the ideal setup for wireless camera communication, the two carts have a direct line of sight to each other. If people are positioned directly between the antennas, wireless connection may be negatively influenced. If wireless camera communication appears to be unstable, use cable-based communication.
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