Microscope Navigation 0 - Brainlab User Guides...• M525 OH4/OHC4, F50/F40, C50/C40 Leica...

MICROSCOPENAVIGATIONMICROSCOPE INTERFACE CABLES

Hardware User GuideRevision 1.0Date of issue: 2020-05-26 (ISO 8601)Copyright 2020, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS1 GENERAL INFORMATION.............................................................................................5

1.1 Contact Data ........................................................................................................................................5

1.2 Legal Information ...............................................................................................................................6

1.3 Symbols................................................................................................................................................7

1.4 Using the System ...............................................................................................................................8

1.5 Compatibility with Medical Devices and Software ....................................................................10

1.6 Training and Documentation..........................................................................................................11

2 Microscope Interface Cables...................................................................................13

2.1 Microscope Navigation ...................................................................................................................13

2.2 Cables Overview ...............................................................................................................................14

2.3 Strain Relief .......................................................................................................................................16

2.4 Cleaning..............................................................................................................................................17

3 LEICA MICROSCOPES ..................................................................................................19

3.1 Connection to Curve 1.0 .................................................................................................................19

3.2 Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted)..........................20

3.3 Connection to Curve Ceiling-Mounted ........................................................................................21

3.4 Connection to Curve Navigation ...................................................................................................22

3.5 Connection to Kick 1.x and Kick 2.x ............................................................................................23

4 HAAG-STREIT MICROSCOPES.............................................................................25





5 ZEISS MICROSCOPES ...................................................................................................29

TABLE OF CONTENTS

Hardware User Guide Rev. 1.0 Microscope Navigation 3




5.4 Connection to Curve Navigation ...................................................................................................32


TABLE OF CONTENTS

4 Hardware User Guide Rev. 1.0 Microscope Navigation

1 GENERAL INFORMATION1.1 Contact Data

Support

If you cannot find information you need in this guide, or if you have questions or problems, contactBrainlab support:

Region Telephone and Fax Email

United States, Canada, Centraland South America

Tel: +1 800 597 5911Fax: +1 708 409 1619

[email protected]

Brazil Tel: (0800) 892 1217 [email protected]

UK Tel: +44 1223 755 333

[email protected]

Spain Tel: +34 900 649 115

France and French-speakingregions Tel: +33 800 676 030

Africa, Asia, Australia, EuropeTel: +49 89 991568 1044Fax: +49 89 991568 5811

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

Expected Product Lifetime

Brainlab provides five years of service for this product.

Feedback

Despite careful review, this user guide may contain errors. Please contact us [email protected] if you have improvement suggestions.

Manufacturer

Brainlab AGOlof-Palme-Str. 981829 MunichGermany

GENERAL INFORMATION


mailto://[email protected]



mailto:[email protected]

1.2 Legal Information

Copyright

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

Brainlab Trademarks

• Brainlab® is a registered trademark of Brainlab AG.• Curve® is a registered trademark of Brainlab AG.• Kick® is a registered trademark of Brainlab AG.

Non-Brainlab Trademarks

• Leica, ARVEO® is a registered trademark of Leica Microsystems CMS GmbH.• HAAG-STREIT® is a registered trademark of Haag-Streit Holding AG.• KINEVO®, OPMI®, Pentero®, Pentero C®, PENTERO® and TIVATO® 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 indicates that the Brainlab product complies with the essential re-quirements of the Council Directive 93/42/EEC ("MDD").Microscope Navigation is a Class IIb product according to the rules establishedby the MDD.

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 relevant substances that could be present in the medical equipment,visit:www.brainlab.com/sustainability

Report Incidents Related to This Product

You are required to report any serious incident that may have occurred related to this product toBrainlab, and if within Europe, to your corresponding national competent authority for medicaldevices.

Sales in US

US federal law restricts this device to sale by or on the order of a physician.

Legal Information


https://www.brainlab.com/patent/

https://www.brainlab.com/sustainability/

1.3 Symbols

Warnings

WarningWarnings are indicated by triangular warning symbols. They contain safety-criticalinformation regarding possible injury, death or other serious consequences associatedwith device use or misuse.

Cautions

Cautions are indicated by circular caution symbols. They contain important informationregarding potential device malfunctions, device failure, damage to device or damage toproperty.

Notes

NOTE: Notes are formatted in italic type and indicate additional useful hints.

Product Symbols

Symbol Explanation

Keep dry

Manufacturer's batch code

Reference (article) numberNOTE: Indicates the Brainlab product number.

Manufacturer

Consult instructions for use

U.S. federal law restricts this device to sale by or on order of a physician

Unique Device Identifier

Medical Device

GENERAL INFORMATION


1.4 Using the System

Abbreviated Device Description

Microscope Navigation is software that runs on a Brainlab IGS platform or Brainlab navigationsystem, which consists of a computer, a display and an infra-red (IR) tracking camera. It can beused in conjunction with other Brainlab Image Guided Surgery (IGS) software. The connectionbetween the surgical microscope and the Brainlab navigation system is established by adedicated microscope integration cable. Designed to assist during surgeries that utilize a surgicalmicroscope, the software links the microscope view to the preoperative patient image data andprovides information based on:• The field of view through the microscope.• The microscope position relative to the patient.• The patient's medical imaging data.The microscope position is tracked during surgery so that patient image data can be displayed/superimposed over the corresponding patient anatomy, either on the monitor or through themicroscope's Head-Up Display (HUD).For orientation, the optical axis and focus point are displayed on the corresponding location on thepatient's image set. The focus point can also be displayed in the connected navigation application.The software provides functionality to verify and correct a patient registration provided by the IGSsoftware.Furthermore, it offers motorized movement functionality of supported surgical microscopes.

Intended Use and Indications for Use

The Microscope Navigation is a device, that when used with a Brainlab navigation system andcompatible instrument accessories, is intended as image guided planning and navigation systemto enable open and minimally invasive surgery.It links an instrument and the view of the surgical field (e.g., video, view through surgicalmicroscope) to a virtual computer image space on patient image data being processed by thenavigation workstation.The device is indicated for any medical condition in which a reference to a rigid anatomicalstructure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of theanatomy.

Place of Use

The application is developed to run on Brainlab IGS Platform or navigation system, which shall beused in hospital environments, specifically in rooms which are appropriate for surgicalinterventions (e.g. operation rooms).

User Profiles

The intended user profile is defined as follows:• Brainlab software, hardware and platforms are used by surgeons (neuro, ortho, spinal, trauma),

surgeon’s assistants and OR-nurses.• Brainlab hardware and platforms are handled by trained OR staff and maintained by trained

Brainlab personnel.

Patient Population

There are no demographic or regional limitations for patients. It is up to the surgeon to decide ifthe system shall be used to assist a certain treatment.

Using the System


Careful Handling of Hardware

System components and accessory instrumentation are comprised of precise mechanicalparts. Handle them carefully.

Plausibility Review

WarningBefore patient treatment, review the plausibility of all information input to and output fromthe system.

GENERAL INFORMATION


1.5 Compatibility with Medical Devices and Software

Compatible Non-Brainlab Surgical Microscopes

Model Manufacturer

• HS 5-1000 (Hi-R 1000 + FS 5-33)• HS 3-1000 (Hi-R 1000 + FS 3-43)• HS Hi-R 700 (FS 2-23, FS 3-43, FS 5-33)• MÖLLER 20-1000 (Hi-R 1000 + FS 4-20)

HAAG-STREIT SURGICAL/ MÖLLER-WEDEL GmbHRosengarten 1022880 WedelGermany

• M530 OHX• M530 OH6• ARVEO• M720 OH5/OHC5• M525 OH4/OHC4, F50/F40, C50/C40

Leica Microsystems (Schweiz) AGMax Schmidheiny-Strasse 2019435 HeerbruggSwitzerland

• KINEVO 900• TIVATO 700• OPMI PENTERO 900• OPMI PENTERO 800• OPMI Pentero/Pentero C

Carl Zeiss Meditec AGSite OberkochenRudolf-Eber-Straße 1173447 OberkochenGermany

Additional surgical microscopes may become available after release of this manual. ContactBrainlab support if you have any questions regarding compatibility with Brainlab software.

Non-Brainlab Devices

Using medical device combinations which have not been authorized by Brainlab may adverselyaffect safety and/or effectiveness of the devices, and endanger safety of patient, user, and/orenvironment.

Compatibility with Medical Devices and Software


1.6 Training and Documentation

Brainlab Training

Before using the system, all users must participate in a mandatory training program held by aBrainlab 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

GENERAL INFORMATION


Training and Documentation


2 MICROSCOPE INTERFACECABLES

2.1 Microscope Navigation

General Information

Microscopes from various manufacturers can be set up for use with Brainlab navigation systems.The connection between the surgical microscope and the Brainlab navigation system isestablished by a dedicated microscope integration cable.The navigation system can determine the viewing direction, the focus point, and the field of viewdiameter of the microscope and display the information on the navigation screen.To set up a microscope:• A Microscope Adapter Set must be attached to the microscope.• The microscope and the navigation system must be connected using the correct microscope

integration cable.For more information on the Microscope Adapter Set, refer to the Cranial/ENT Optical TrackingInstrument User Guide.

Before Using

Read the relevant Software User Guide before performing microscope navigation.

MICROSCOPE INTERFACE CABLES


2.2 Cables Overview

Cables List

①

② ③ ④

⑤

⑥⑦⑧

Figure 1

No. Cable Name Article No.

① BREAKOUT INTERFACE CABLE FOR CURVE 1.0 15234B

② BNC CABLE 10 M 18562-08

③ MICROSCOPE INTERFACE CABLE 2.0 (HAAG-STREIT/MOELLER/OLYMPUS) 15204

④ SVGA MONITOR CABLE MALE-MALE 10 M 15229A

⑤ (CAN BUS) MICROSCOPE INTERFACE CABLE 2.0 (LEICA) 15222C

⑥ MICROSCOPE INTERFACE CABLE 2.0 (ZEISS) 15217C

⑦

MICROSCOPE INTERFACE CABLE 3.0 (ZEISS) (shown) 15235-01

MICROSCOPE INTERFACE CABLE 3.0 (LEICA) 15236-01

MICROSCOPE INTERFACE CABLE 3.0 (HAAG-STREIT/MOELLER) 15237-01

⑧

MICROSCOPE INTERFACE CABLE (ZEISS KINEVO 900) 15240

MICROSCOPE INTERFACE CABLE 4.0 (ZEISS KINEVO 900STEREO) 15241-01

MICROSCOPE INTERFACE CABLE 4.0 (ZEISS KINEVO900/TIVATO 700) (shown) 15241-02

MICROSCOPE INTERFACE CABLE 4.0 (ZEISS) 15241-03

MICROSCOPE INTERFACE CABLE 4.0 (LEICA) 15241-04

Cables Overview


Cabling

• Do not connect additional hardware to the original setting after calibration.• Do not connect devices other than a valid calibrated video camera to the video port of the

navigation system.• Make sure that there is enough space for the movement range of the microscope head when

connecting it.• Do not expose the system to direct UV light, as it may damage equipment.

NOTE: For further information about electrical safety, see the relevant System and TechnicalUser Guide and/or the manufacturer's instructions for use for your microscope.



2.3 Strain Relief

About Strain Relief

Ensure safe usage by using strain relief loops to keep the cabling free from snagging hazards.

How to Attach the Strain Relief

①

②

③ ④

⑤Figure 2

Step

1. Put the hook and loop strap through the strain relief loops of the microscope cable, wrap-ping the strap once around the cable ①.

2. Attach the microscope cable with the hook and loop strap:• To the rail of the ceiling unit, when using the Curve Ceiling-Mounted and Buzz Navi-

gation (Ceiling-Mounted) systems ②.• To the strain relief adapter, when using the Curve Navigation 17700 ③, Curve ④ and

Kick systems ⑤.NOTE: The Curve Navigation 17700 system will be referred to from this point forward asCurve Navigation.

Strain Relief


2.4 Cleaning

Before You Begin

Ensure that the system is fully shut down and disconnected from mains power before beginningcleaning.

No Automatic Disinfection

Do not use automatic cleaning and disinfection procedures for the system components.

No Sterilization

Do not sterilize any part of the system. High temperatures from sterilization may damagecomponents.

No Liquids

Ensure that liquids do not enter the system, as this could damage the component and/or theelectronics.

Disinfectant Types

The cabling shall only be cleaned using the following disinfectant types:• alcohol-based (e.g., Meliseptol, Mikrozid AF Liquid)• alkylamine-based (e.g., Incidin Plus 2%)• active oxygen-based (e.g., Perform)• aldehyde/chloride-based (e.g., Antiseptica Kombi - Flächendesinfektion)

NOTE: Use only surface disinfectants released in your specific market.

Cleaning the Cables

To clean the microscope interface cables:

Step

1. Shut down the connected systems.

2. Disconnect the cable from the connected systems.

3. Close the connectors using cable caps if provided.

4. Clean the cable surfaces using a surface disinfectant (see list of Brainlab approved disin-fectants). Follow disinfectant manufacturer's recommendations.NOTE: Use a dry cloth to remove any surface disinfectant residue.

5. Carefully clean the surface of the connectors, ensuring that no liquids enter the connector.



Cleaning


3 LEICA MICROSCOPES3.1 Connection to Curve 1.0

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve 1.0 system according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop strap provided. This strap fits through the hole located on the foot of the system.

The compatible Leica microscopes are:• M525 (OH4/OHC4, F50/F40, C50/C40)• M530 (OHX, OH6, ARVEO)• M720 (OH5/OHC5)

Leica M525/M530/M720 (SAI)

Figure 3

NOTE: It is recommended to use an HD-SDI connection if available.

LEICA MICROSCOPES


3.2 Connection to Curve 1.1 and 1.2 and BuzzNavigation (Ceiling-Mounted)

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on thenavigation systems according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop strap provided. This strap fits through the hole located on the foot of the system.

NOTE: Secure any loose cables that hang from the Buzz Navigation (Ceiling-Mounted)Connection Unit to the rail of the ceiling supply unit (CSU) with the hook and loop strap.



Figure 4


Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted)


3.3 Connection to Curve Ceiling-Mounted

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve Ceiling-Mounted system according to the following diagrams.NOTE: Secure any loose cables that hang from the Curve Ceiling-Mounted Connection Unit tothe rail of the ceiling supply unit (CSU) with the hook and loop strap.



Figure 5

LEICA MICROSCOPES


3.4 Connection to Curve Navigation

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve Navigation system according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop strap provided. This strap fits through the hole located on the foot of the system.

NOTE: The Curve Navigation system is only compatible with Microscope Navigation 1.6software and above.



Figure 6


Connection to Curve Navigation


3.5 Connection to Kick 1.x and Kick 2.x

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theKick system according to the following diagrams.NOTE: Secure any loose cables that hang from Kick to the base of the system with the hook andloop strap provided. This strap fits through the hole located on the foot of the system.



Figure 7

LEICA MICROSCOPES


Connection to Kick 1.x and Kick 2.x


4 HAAG-STREITMICROSCOPES

4.1 Connection to Curve 1.0

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve 1.0 system according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop straps provided. These straps fit through the hole located on the foot of the system.

Haag-Streit Hi-R 1000/Hi-R 700

Figure 8

NOTE: Image injection (HUD) is not available for Haag-Streit Hi-R 700.


HAAG-STREIT MICROSCOPES



How to Connect



Haag-Streit Hi-R 1000/ Hi-R 700

Figure 9






How to Connect



Figure 10


HAAG-STREIT MICROSCOPES



How to Connect



Figure 11




5 ZEISS MICROSCOPES5.1 Connection to Curve 1.0

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve 1.0 system according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop straps provided. This strap fits through the hole located on the foot of the system.

Zeiss OPMI Pentero/Pentero C/PENTERO 800/PENTERO 900, KINEVO 900 (Legacy ODU Interface)

Figure 12


ZEISS MICROSCOPES



How to Connect



Zeiss OPMI Pentero/Pentero 900

Figure 13

Zeiss KINEVO 900 (Advanced LAN Interface), TIVATO 700 (Advanced LAN Interface)

Figure 14

NOTE: Image injection (HUD) is not available for TIVATO 700.




How to Connect


Zeiss OPMI Pentero/PENTERO 800/PENTERO 900, KINEVO 900 (Legacy ODU Interface)

Figure 15

Zeiss TIVATO 700

Figure 16

ZEISS MICROSCOPES


5.4 Connection to Curve Navigation

How to Connect

Connect the supplied cables between the microscope ports and the corresponding ports on theCurve Navigation system according to the following diagrams.NOTE: Secure any loose cables that hang from Curve to the base of the system with the hookand loop strap provided. This strap fits through the hole located on the foot of the system.

NOTE: The Curve Navigation system is only compatible with Microscope Navigation 1.6software and above.

ZEISS Pentero, PENTERO 800/ PENTERO 900

Figure 17

NOTE: Only HD-SDI can be integrated.

ZEISS KINEVO 900 (Advanced LAN Interface), TIVATO 700 (Advanced LAN Interface)

Figure 18

NOTE: Image injection (HUD) is not available for TIVATO 700.

Connection to Curve Navigation



How to Connect


Zeiss OPMI Pentero

Figure 19

Zeiss OPMI PENTERO 800/PENTERO 900

① ②

Figure 20

No. Component

① Adapter cable SVHS to 2BNC

② FGA 2B-4St/S-VHS-St 10m

NOTE: The Zeiss LEMO S-VIDEO cable (000000-0457-982) is provided by Zeiss.

ZEISS MICROSCOPES


INDEXD

disposal instructions..................................................................... 6

Mmaintenance...............................................................................17microscopes

Haag-Streit, connection to navigation system........................ 25Leica, connection to navigation system..................................19Microscope Adapter Set......................................................... 13Zeiss, connection to navigation system..................................29

Ssafe disposal................................................................................ 6support numbers.......................................................................... 5sustainability.................................................................................6

Wwaste electrical and electronic equipment (WEEE)......................6

INDEX


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