Brainlab CRANIAL/ENT OPTICAL User manual

CRANIAL/ENT
OPTICAL
Instrument User Guide
Revision 2.3
Copyright 2019, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................7
1.1 Contact Data........................................................................................................................................7
1.2 Legal Information ...............................................................................................................................8
1.3 Symbols..............................................................................................................................................10
1.4 Using the System .............................................................................................................................14
1.5 Training and Documentation..........................................................................................................15
2 INSTRUMENTATION OVERVIEW..........................................................................17
2.1 Instrument Overview........................................................................................................................17
2.1.1 Available Instruments.......................................................................................................................19
3 GENERAL INSTRUMENTATION............................................................................23
3.1 Disposable Reflective Marker Spheres........................................................................................23
3.1.1 Using Marker Spheres......................................................................................................................24
3.2 Disposable Registration Markers..................................................................................................26
3.2.1 Attaching Markers ............................................................................................................................28
3.3 Suction Tubes....................................................................................................................................31
3.4 Instrument Calibration Matrix........................................................................................................32
4 POINTERS..................................................................................................................................35
4.1 Pointer Cranial/ENT with Blunt Tip...............................................................................................35
4.2 Multiple Tip Pointer Package.........................................................................................................37
4.3 Softouch Pointer...............................................................................................................................39
4.3.1 Softouch Pointer Technical Information ............................................................................................43
4.4 Z-touch Laser Pointer......................................................................................................................45
4.4.1 Z-touch Laser Beams.......................................................................................................................47
4.4.2 Control LED and Laser Indications...................................................................................................49
4.4.3 Z-touch Laser Pointer Technical Information ....................................................................................52
4.5 Pointer Electromagnetic Information...........................................................................................54
5 REFERENCES.........................................................................................................................57
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5.1 Standard Cranial Reference Array................................................................................................57
5.1.1 Positioning Arrays ............................................................................................................................59
5.2 Reference Clamp Universal............................................................................................................61
5.3 Vario Reference Arm for Mayfield Headholder ..........................................................................64
5.3.1 Attaching Arm to Headholder ...........................................................................................................65
5.4 Reference Headband .......................................................................................................................68
5.5 Skull Reference Package................................................................................................................70
5.5.1 Screwdriver......................................................................................................................................71
5.5.2 Assembly and Attachment................................................................................................................72
5.5.3 Removing the Skull Reference Package ..........................................................................................76
6 INSTRUMENT ADAPTERS..........................................................................................79
6.1 Instrument Adapter Package .........................................................................................................79
6.1.1 Instrument Adapter Accessory .........................................................................................................82
6.2 Instrument Adapter Clamps for Rectangular/Cylindrical Instruments.................................83
7 ULTRASOUND........................................................................................................................85
7.1 Ultrasound Adapters........................................................................................................................85
7.1.1 Components.....................................................................................................................................86
7.1.2 Attaching the Unique Fit Adapter Base to the Probe ........................................................................88
7.1.3 Attaching the Standard Fit Adapter to the Probe ..............................................................................90
7.1.4 Ultrasound Calibration......................................................................................................................93
7.1.5 Draping Ultrasound Adapters...........................................................................................................94
8 BIOPSY INSTRUMENT HOLDERS......................................................................97
8.1 Frameless Biopsy System..............................................................................................................97
8.2 VarioGuide .......................................................................................................................................102
8.2.1 Assembly .......................................................................................................................................104
8.2.2 Attaching the VarioGuide to the Skull Clamp..................................................................................107
9 MICROSCOPES...................................................................................................................109
9.1 Microscope Adapter Sets .............................................................................................................109
9.2 Draping .............................................................................................................................................111
9.3 Strain Relief .....................................................................................................................................112
9.4 Attaching the Microscope Tracking Array (41767-19) to the Microscope Adapter..........113
9.4.2 Available Microscope Adapter Kits.................................................................................................114
9.5 Leica Microscopes.........................................................................................................................117
9.5.1 Connection to Curve 1.1 and Above...............................................................................................118
9.5.2 Connection to Curve ceiling-mounted.............................................................................................119
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9.5.3 Connection to Kick 1.0 and Kick 2.0...............................................................................................120
9.5.4 Connection to Kolibri......................................................................................................................121
9.5.5 Connection to VectorVision sky......................................................................................................122
9.6 Haag-Streit Microscopes ..............................................................................................................123
9.6.1 Connection to Curve 1.1 and Above...............................................................................................124
9.6.2 Connection to Curve ceiling-mounted.............................................................................................125
9.6.3 Connection to Kick 1.0 and Kick 2.0...............................................................................................126
9.6.4 Connection to Kolibri......................................................................................................................127
9.6.5 Connection to VectorVision sky......................................................................................................128
9.7 Olympus Microscopes...................................................................................................................129
9.7.1 Connection to Curve 1.1 and Above...............................................................................................131
9.7.2 Connection to Curve ceiling-mounted.............................................................................................132
9.7.3 Connection to Kick 1.0 and Kick 2.0...............................................................................................133
9.7.4 Connection to Kolibri......................................................................................................................134
9.7.5 Connection to VectorVision sky......................................................................................................135
9.8 Zeiss Microscopes.........................................................................................................................136
9.8.1 Connection to Curve 1.1 and Above...............................................................................................138
9.8.2 Connection to Curve ceiling-mounted.............................................................................................140
9.8.3 Connection to Kick 1.0 and Kick 2.0...............................................................................................141
9.8.4 Connection to Kolibri......................................................................................................................142
9.8.5 Connection to VectorVision sky......................................................................................................143
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Instrument User Guide Rev. 2.3 Cranial/ENT Optical 5

TABLE OF CONTENTS
6 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

1 GENERAL INFORMATION
1.1 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: [phone]
Fax: [phone] [email protected]
Brazil Tel: [phone] [email protected]
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking
regions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
Expected Service Life
Unless specifically stated otherwise, Brainlab provides five years of service for instruments.
During this period of time, spare parts as well as field support are offered.
Feedback
Despite careful review, this user guide may contain errors. Please contact us at
user[email protected] if you have improvement suggestions.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 7

1.2 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
•Brainlab®is a trademark of Brainlab AG.
•iHelp®is a trademark of Brainlab AG.
•Softouch®is a trademark of Brainlab AG.
•StarLink®is a trademark of Brainlab AG.
•VarioGuide®is a trademark of Brainlab AG.
•Z-touch®is a trademark of Brainlab AG.
Non-Brainlab Trademarks
Doro®is a registered trademark of pro med instruments GmbH
MAYFIELD®is a registered trademark of Integra Lifesciences Holding Corp.
MultiVision™is a trademark of Carl Zeiss Meditec AG.
OPMI®, Pentero®, and PENTERO®are registered trademarks of Carl Zeiss Meditec AG.
Patent Information
This product may be covered by one or more patents or pending patent applications. For details,
see: www.brainlab.com/patent.
CE Label
The CE label shows that the Brainlab product complies with the essential re-
quirements of Council Directive 93/42/EEC (the “MDD”).
According to the rules established by the MDD, the classification of the Brain-
lab product is defined in the corresponding Software User Guide.
NOTE: The validity of the CE label can only be confirmed for products manu-
factured by Brainlab.
Disposal Instructions
When a medical device reaches the end of its functional life, clean the device of all biomaterial/
biohazards and safely dispose of the device in accordance with applicable laws and regulations.
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 or relative substances that could be present in the medical equipment,
visit:
www.brainlab.com/sustainability
Report Incidents Related to This Product
Legal Information
8 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

You are required to report any serious incident that may have occurred related to this product to
Brainlab, and if within Europe, to your corresponding national competent authority for medical
devices.
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
GENERAL INFORMATION
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 9

1.3 Symbols
Warnings
Warning
Warnings are indicated by triangular warning symbols. They contain safety-critical
information regarding possible injury, death or other serious consequences associated
with device use or misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain important information
regarding potential device malfunctions, device failure, damage to device or damage to
property.
Notes
NOTE: Notes are formatted in italic type and indicate additional useful hints.
Symbols on Hardware Components
The below symbols may be found on the system.
Symbol Explanation
Type B Applied Part
NOTE: Applied parts that are normally not conductive and can be immediately re-
leased from the patient.
Type BF Applied Part
NOTE: Applied parts that have conductive contact with the patient, or have medium
or long term contact with the patient.
Caution
NOTE: User should consult the instructions for use for important cautionary informa-
tion such as warnings and precautions that cannot, for a variety of reasons, be pre-
sented on the medical device itself.
Equipotentiality
NOTE: To identify the terminals which, when connected together, bring the various
parts of an equipment or of a system to the same potential, not necessarily being the
earth (ground) potential.
Do not re-use
NOTE: Indicates a medical device that is intended for one use, or for use on a single
patient during a single procedure.
Non-sterile
NOTE: Indicates a medical device that has not been subjected to a sterilization proc-
ess.
Do not resterilize
NOTE: Indicates a medical device that should not be resterilized.
Symbols
10 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

Symbol Explanation
Sterilized with ethylene oxide
Sterilized with irradiation
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
Temperature limit
NOTE: Indicates the temperature limits to which the medical device can be safely
exposed.
Humidity limitation
NOTE: Indicates the range of humidity to which the medical device can be safely ex-
posed.
Atmospheric pressure limitation
NOTE: Indicates the range of atmospheric pressure to which the medical device can
be safely exposed.
Quantity of included items
Manufacturer's batch code
Manufacturer's serial number
Reference (article) number
NOTE: Indicates Brainlab's product number.
Use by date
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Date of manufacture
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Manufacturer
Authorized representative in the European Community
GENERAL INFORMATION
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 11

Symbol Explanation
IPXY
Ingress Protection Rating
• Protection against foreign solids (numbers 0 to 6, or letter X).
• Protection against foreign liquids (numbers 0 to 9, or letter X).
NOTE: The letter X is listed if insufficient data has been gathered to assign a protec-
tion level.
NOTE: Refer to IEC 60529 for clarification of the number codes.
Consult instructions for use
U.S. federal law restricts this device to sale by or on order of a physician
MR conditional
NOTE: Presents no known hazards in a specific MR environment.
MR Unsafe
NOTE: Presents hazards in all MR environments.
MR Safe
NOTE: Presents no known hazards in any MR environment.
Switch to bring the device into standby mode
Switch to turn the device on/off
Contains or presence of natural rubber latex
NOTE: Presence of natural rubber or dry natural rubber latex as a material of con-
struction within the medical device or the packaging of a medical device.
Non-pyrogenic
Indicates that the equipment is suitable for direct current only
Sitting prohibited
Keep hands clear (pinch point hazard)
Contains an RF transmitter for operation
Symbols
12 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

Symbol Explanation
Class II Equipment
Unique Device Identifier
Refer to instruction manual or booklet
GENERAL INFORMATION
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 13

1.4 Using the System
Intended Purpose
This Instrument User Guide is intended for use with Brainlab Cranial Registration, Navigation and
ENT software and contains information on how to assemble and safely use the required
instruments in surgery.
Careful Handling of Hardware
System components and accessory instrumentation are comprised of precise mechanical
parts. Handle them carefully.
Using the System
14 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

1.5 Training and Documentation
Brainlab Training
Before using the system, all users must participate in a mandatory training program held by a
Brainlab authorized representative to ensure safe and appropriate use.
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
Available User Guides
NOTE: Available user guides vary depending upon the Brainlab product. If you have questions
regarding the user guides you received, please contact Brainlab support.
User Guide Contents
Software User Guides • Overview of treatment planning and image-guided navigation • Description of OR system setup
• Detailed software instructions
Hardware User Guides Detailed information on radiotherapy and surgical hardware, typi-
cally defined as large complex instruments
Instrument User Guides Detailed instructions on instrument handling
Cleaning, Disinfection and
Sterilization Guide Details on cleaning, disinfecting and sterilizing instruments
System User Guide Detailed information on system setup
Technical User Guide Detailed technical information on the system, including specifica-
tions and compliances
System and Technical User
Guide Combines the contents of the System User Guide and the Techni- cal User Guide.
GENERAL INFORMATION
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 15

Training and Documentation
16 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

2 INSTRUMENTATION
OVERVIEW
2.1 Instrument Overview
Further Information
Detailed instructions on the use of instruments with their respective software is provided in your
Software User Guide.
Compatibility
Instruments can only be used with systems or other instruments that have been specified by
Brainlab as compatible. Contact Brainlab support if you are unsure of instrument compatibility.
Correct Handling
Before use, always ensure that each instrument is correctly assembled and all components are
tightly connected and/or locked, if necessary.
During use, regularly check that all instrument components have remained securely attached and
have not become dislodged or damaged. Any movement of fixed instruments during or after
patient registration results in inaccurate navigation, posing a risk to the safety of the patient.
Warning
The instruments described in this user guide are highly accurate and sensitive medical
devices and must be handled with extreme care. If you drop or otherwise damage an
instrument, or if an instrument is corroded or defective in any way, immediately call your
local Brainlab service provider for instructions on how to proceed. Failure to do so and
continued use of a damaged device may lead to serious injury to the patient.
Warning
If you suspect a reference array has been moved or damaged at any time after registration,
immediately stop and verify the array again. Changing an array’s position after registration
disturbs the entire measurement coordinate system, posing a risk to the patient.
Warning
If you suspect an instrument calibration has become inaccurate immediately stop and
verify/validate the instrument again.
Warning
If using marker spheres on, or in the vicinity of, oscillating or vibrating instruments, the
marker spheres must be checked at regular intervals to make sure that they remain
securely attached.
NOTE: Ensure that marker spheres are visible to camera at all times during use.
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 17

Array Positioning
The system recognizes an instrument by the geometrical arrangement of the marker spheres on
its tracking array. For the system to properly identify an instrument, the camera must have a clear
view of its marker spheres at all times.
For the best recognition of the array, position the array perpendicular to the plane through the
centers of all marker spheres.
Possible Complications
Use of some Brainlab products requires an additional incision to be made. Therefore, the following
complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, bone
fracture or thrombosis.
Creutzfeldt-Jakob Contamination
Warning
Do not use Brainlab instrumentation on patients suspected of having Creutzfeldt-Jakob
disease (CJD or vCJD).
MR Safety
Unless otherwise noted, instruments are MR unsafe.
Sterilization
If a sterile instrument or any of its components is inadvertently removed from the sterile field, or
comes into contact with an unsterile object during unpacking or clinical use, it must be sterilized
again.
Do not resterilize or reuse disposable instruments, as this could affect navigation accuracy, posing
a risk to the patient. They must be disposed of after each use.
Warning
Unless otherwise indicated, instruments must be sterilized before use. Detailed information
about reprocessing procedures, parameters and cleaning detergents are available in your
Cleaning, Disinfection & Sterilization Guide.
Instrument Contact to Brain Tissue and Spinal Fluid
Only the following instruments are intended for direct contact with brain tissue and spinal fluid:
•Disposable Biopsy Needle 1.8 mm/235 mm (5 PCS) (41779)
•Disposable Stylet (10 PCS, Pre-Calibrated) (55797)
•Pointer Cranial/ENT with Blunt Tip (53106, 41780-5)
Instrument Overview
18 Instrument User Guide Rev. 2.3 Cranial/ENT Optical

2.1.1 Available Instruments
Disposables & General Instrumentation
Illustration Name
Disposable Reflective Marker Spheres
Disposable Registration Markers
Multi-Modality Fiducial Markers
Disposable Stylet
NOTE: Not detailed in this user guide. See separate in-
structional leaflet for further information.
Disposable Biopsy Needle 1.8 mm/235 mm
NOTE: Not detailed in this user guide. See separate in-
structional leaflet for further information.
Disposable Sterile Touchpen
NOTE: Not detailed in this user guide. See separate in-
structional leaflet for further information.
VarioGuide Drill Kit
NOTE: Not detailed in this user guide. See separate in-
structional leaflet for further information.
Suction Tubes
Instrument Calibration Matrix
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.3 Cranial/ENT Optical 19

Pointers
Illustration Name
Pointer Cranial/ENT with Blunt Tip
Multiple Tip Pointer Package
Softouch Pointer
Z- touch Laser Pointer
References
Illustration Name
Standard Cranial Reference Array (3- and 4-Marker)
Reference Clamp Universal
Vario Reference Arm
Reference Headband and Reference Unit For Head-
band
Skull Reference Package
Available Instruments
20 Instrument User Guide Rev. 2.3 Cranial/ENT Optical