Brainlab CRANIAL/ENT OPTICAL TRACKING User manual

CRANIAL/ENT
OPTICAL
TRACKING
Instrument User Guide
Revision 2.6
Date of issue: 2022-01-13 (ISO 8601)
Copyright 2022, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................5
1.1 Contact Data........................................................................................................................................5
1.2 Legal Information ...............................................................................................................................6
1.3 Symbols................................................................................................................................................7
1.4 Using the System .............................................................................................................................11
1.5 Training and Documentation..........................................................................................................12
2 INSTRUMENTATION OVERVIEW..........................................................................13
2.1 Instrument Overview........................................................................................................................13
2.1.1 Available Instruments and Classification ..........................................................................................16
3 GENERAL INSTRUMENTATION............................................................................21
3.1 Disposable Reflective Marker Spheres........................................................................................21
3.1.1 Using Marker Spheres......................................................................................................................22
3.2 Suction Tubes....................................................................................................................................24
3.2.1 Reusable Suction Tubes .................................................................................................................25
3.3 Instrument Calibration Matrix........................................................................................................27
4 POINTERS..................................................................................................................................29
4.1 Navigation Pointer Cranial/ENT.....................................................................................................29
4.2 Multiple Tip Pointer Package.........................................................................................................31
4.3 Softouch Pointer...............................................................................................................................33
4.3.1 Softouch Pointer Technical Information ............................................................................................37
4.4 Z-touch Laser Pointer......................................................................................................................39
4.4.1 Z-touch Laser Beams.......................................................................................................................41
4.4.2 Control LED and Laser Indications...................................................................................................43
4.4.3 Z-touch Laser Pointer Technical Information ....................................................................................46
4.5 Electromagnetic Compatibility......................................................................................................49
5 REFERENCES.........................................................................................................................53
5.1 Standard Cranial Reference Array................................................................................................53
TABLE OF CONTENTS
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 3

5.1.1 Positioning Arrays ............................................................................................................................55
5.2 Reference Clamp Universal............................................................................................................57
5.3 Vario Reference Arm (Mayfield Headholder)..............................................................................60
5.3.1 Attaching Arm to Headholder ...........................................................................................................62
5.4 Reference Headband .......................................................................................................................65
5.5 Skull Reference Package................................................................................................................67
5.5.1 Screwdriver......................................................................................................................................68
5.5.2 Assembly and Attachment................................................................................................................69
5.5.3 Removing the Skull Reference Package ..........................................................................................73
6 INSTRUMENT ADAPTERS..........................................................................................75
6.1 Arrays and Clamps...........................................................................................................................75
6.1.1 Instrument Adapter Accessories.......................................................................................................79
6.2 Instrument Adapter Clamps for Rectangular/Cylindrical Instruments.................................81
6.3 Instrument Adapter Clamp Softgrip (Size L, XL) .......................................................................83
7 ULTRASOUND........................................................................................................................87
7.1 Ultrasound Adapters........................................................................................................................87
7.1.1 Attaching the Unique Fit Adapter Base to the Probe ........................................................................89
7.1.2 Generic Ultrasound Adapter Base Kit...............................................................................................91
7.1.3 Ultrasound Calibration......................................................................................................................93
8 TRAJECTORY ALIGNMENT TOOLS.................................................................95
8.1 VarioGuide .........................................................................................................................................95
8.1.1 Assembly .........................................................................................................................................97
8.1.2 Attaching the VarioGuide to the Head Holder.................................................................................100
9 MICROSCOPES...................................................................................................................103
9.1 Microscope Adapter Sets .............................................................................................................103
9.2 Draping .............................................................................................................................................105
9.3 Attaching the Microscope Tracking Array (41767-19) to the Microscope Adapter..........106
9.3.2 Available Microscope Adapter Kits.................................................................................................107
INDEX..................................................................................................................................................109
TABLE OF CONTENTS
4 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

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 Product Lifetime
Unless specifically stated otherwise, Brainlab provides five years of service for instruments. See
the information about each instrument in this guide for more details. During the expected product
lifetime, 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. 2.6 Cranial/ENT Optical Tracking 5

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.
•Softouch®is a trademark of Brainlab AG.
•VarioGuide®is a trademark of Brainlab AG.
•Z-touch®is a trademark of Brainlab AG.
Non-Brainlab Trademarks
Cortex Screw Plus-Drive™self-drill is a trademark of Synthes GmbH.
Doro®is a trademark of pro med instruments GmbH.
Max-Drive®drill-free is a trademark of Gebrüder Martin GmbH & Co. KG.
MAYFIELD®is a trademark of Integra Lifesciences Holding Corp.
MultiVision™is a trademark of Carl Zeiss Meditec AG.
OPMI®, Pentero®, and PENTERO®are 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.
Disposal Instructions
When a surgical instrument reaches the end of its functional life, clean the instrument of all
biomaterial/biohazards and safely dispose of the instrument 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 relevant substances that could be present in the medical equipment,
visit: www.brainlab.com/weee/
Report Incidents Related to This Product
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.
Legal Information
6 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

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 hardware components:
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.
GENERAL INFORMATION
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 7

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
Symbols
8 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

Symbol Explanation
IPXX
Ingress Protection Rating
• First digit: Protection against foreign solids (numbers 0 to 6, or letter X).
• Second digit: 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
GENERAL INFORMATION
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 9

Symbol Explanation
Class II Equipment
Unique Device Identifier
Single sterile barrier system with protective packaging inside
Double sterile barrier system
Follow instructions for use
Medical Device
Symbols
10 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

1.4 Using the System
Purpose of this User Guide
This Instrument User Guide is intended for use with Brainlab IGS Cranial 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.
GENERAL INFORMATION
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 11

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.
Supervised Support
Before using the system for surgical procedures where computer-aided navigation is considered
critical, perform a sufficient number of complete procedures together with a Brainlab
representative.
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.
Training and Documentation
12 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

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
Verify devices you suspect inaccurate on known anatomical landmarks or using the ICM.
Replace inaccurate devices or return them to Brainlab for further inspection/testing.
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 13

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.
Warning
Set up the OR considering permanent visibility of all navigated equipment.
The cameras should have an unobstructed view of the reflective marker spheres on the
tracking array. The marker spheres shall not be masked. Otherwise, navigation is not
possible or inaccuracies may occur during navigation. Plan the OR setup prior to surgery.
The camera must have an unobstructed view of the reflective marker spheres of the
instrument.
NOTE: Ensure that marker spheres are visible to camera at all times during use.
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).
Sterilization
If a sterile and reusable 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 and Sterilization Guide. Reprocess reusable devices according to
the descriptions in the Cleaning, Disinfection and 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)
•Disposable Pre-calibrated Suction Charr. 8 (10 PCS) (52184)
•Disposable Pre-calibrated Suction Charr. 12 (10 PCS) (52185)
Instrument Overview
14 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

•Navigation Pointer Cranial/ENT (41780-5)
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 15

2.1.1 Available Instruments and Classification
Disposables and General Instrumentation
Illustration Name Cranial ENT
Disposable Pre-calibrated Suction
NOTE: Not detailed in this user guide. See sepa-
rate instructional leaflet for further information.
NOTE: Visually inspect for breaches in the sterile
barrier system integrity prior use.
Yes No
Disposable Reflective Marker Spheres
NOTE: Visually inspect for breaches in the sterile
barrier system integrity prior use.
Yes Yes
Disposable Stylet
NOTE: Not detailed in this user guide. See sepa-
rate instructional leaflet for further information.
NOTE: Visually inspect for breaches in the sterile
barrier system integrity prior use.
Yes No
Reusable Suction Tubes No Yes
Instrument Calibration Matrix Yes Yes
Pointers
Illustration Name Cranial ENT
Pointer Cranial/ENT with Blunt Tip Yes Yes
Multiple Tip Pointer Package Yes Yes
Softouch Pointer Yes Yes
Z- touch Laser Pointer Yes Yes
Available Instruments and Classification
16 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

References
Illustration Name Cranial ENT
Standard Cranial Reference Array (4-Marker) Yes Yes
Reference Clamp Universal Yes Yes
Vario Reference Arm Yes Yes
Reference Headband and Reference Unit for
Headband Yes Yes
Skull Reference Package Yes Yes
Instrument Adapters
Illustration Name Cranial ENT
Instrument Adapter Package
NOTE: Instrument Adapter Array (Starlink), Size
M only to be used for ENT.
Yes Yes
Instrument Adapter Clamps for Rectangular/
Cylindrical Instruments Yes Yes
Instrument Adapter Offset-link 45° 20 mm Yes Yes
Instrument Adapter Extension 50 mm Yes Yes
Ultrasound
Illustration Name Cranial ENT
Ultrasound Adapters Yes No
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 17

Illustration Name Cranial ENT
Ultrasound Registration Phantom Yes No
Trajectory Alignment Tools
Illustration Name Cranial ENT
VarioGuide Yes No
V-Insets Yes No
Microscope Adapters
Illustration Name Cranial ENT
Microscope Tracking Array and Adapter Sets Yes No
Available Instruments and Classification
18 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking

Compatible Non-Brainlab Medical Devices
Medical Device Model Manufacturer Cranial ENT
Cranial Fixation
Device
Head Holder for intra-op-
erative CT and MRI:
Mayfield, Doro, Noras,
GE, or similar construc-
tion
Integra Neurosciences
311 Enterprise Drive
Plainsboro, NJ 08536
USA
Pro Med Instruments
GmbH
Bötzinger Str. 38
79111 Freiburg
Germany
Noras MRI products
GmbH
Leibnizstrasse 4
97204 Höchberg
Germany
GE Healthcare
3000 North Grandview
Waukesha, WI 53188
USA
Yes No
Self-drilling screw
1.5 x 6 mm maxDrive
drill-free (Martin) or Cor-
tex Screw PlusDrive self-
drill (Synthes)
Gebrüder Martin GmbH
and Co. KG
Ludwigstaler Str. 132
78532 Tuttlingen Germany
Synthes GmbH
Eimattstr. 3
4436 Oberdorf
Switzerland
Yes Yes
Screwdriver blade 1.5 mm (appropriate for
used screws) Yes Yes
Screwdriver handle Appropriate for used
blade and screws Yes Yes
Drill bit and handle
(optional) 1.1 mm Yes Yes
Disposable Biopsy
Needle Type A
PAJUNK GmbH
Karl-Hall-Strasse 1
78187 Geisingen
Germany
Yes No
Multi-Modality Do-
nut Registration
Markers
IZI Medical Products
7020 Tudsbury Road
Baltimore, MD 21244
USA
Yes Yes
INSTRUMENTATION OVERVIEW
Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking 19

Available Instruments and Classification
20 Instrument User Guide Rev. 2.6 Cranial/ENT Optical Tracking