User Guide
38 Pages
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MICROSCOPE NAVIGATION MICROSCOPE INTERFACE CABLES
Hardware User Guide Revision 1.0 Date of issue: 2020-05-26 (ISO 8601) Copyright 2020, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
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 ...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 4.1 Connection to Curve 1.0 ...25 4.2 Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted) ...26 4.3 Connection to Curve Ceiling-Mounted ...27 4.4 Connection to Kick 1.x and Kick 2.x ...28
5 ZEISS MICROSCOPES ...29 Hardware User Guide Rev. 1.0 Microscope Navigation
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TABLE OF CONTENTS
5.1 Connection to Curve 1.0 ...29 5.2 Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted) ...30 5.3 Connection to Curve Ceiling-Mounted ...31 5.4 Connection to Curve Navigation ...32 5.5 Connection to Kick 1.x and Kick 2.x ...33
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GENERAL INFORMATION
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
United States, Canada, Central Tel: +1 800 597 5911 and South America Fax: +1 708 409 1619
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
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 at [email protected] if you have improvement suggestions.
Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany
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Legal Information
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 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 requirements of the Council Directive 93/42/EEC ("MDD"). Microscope Navigation is a Class IIb product according to the rules established by 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 regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) 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 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.
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GENERAL INFORMATION
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.
Product Symbols Symbol
Explanation
Keep dry
Manufacturer's batch code Reference (article) number NOTE: 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
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Using the System
1.4
Using the System
Abbreviated Device Description Microscope Navigation is software that runs on a Brainlab IGS platform or Brainlab navigation system, which consists of a computer, a display and an infra-red (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. The connection between the surgical microscope and the Brainlab navigation system is established by a dedicated microscope integration cable. Designed to assist during surgeries that utilize a surgical microscope, the software links the microscope view to the preoperative patient image data and provides 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 the microscope's Head-Up Display (HUD). For orientation, the optical axis and focus point are displayed on the corresponding location on the patient'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 IGS software. 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 and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery. It links an instrument and the view of the surgical field (e.g., video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation workstation. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.
Place of Use The application is developed to run on Brainlab IGS Platform or navigation system, which shall be used in hospital environments, specifically in rooms which are appropriate for surgical interventions (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 if the system shall be used to assist a certain treatment.
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GENERAL INFORMATION
Careful Handling of Hardware System components and accessory instrumentation are comprised of precise mechanical parts. Handle them carefully.
Plausibility Review Warning Before patient treatment, review the plausibility of all information input to and output from the system.
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Compatibility with Medical Devices and Software
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/ MÖLLERWEDEL GmbH Rosengarten 10 22880 Wedel Germany
• M530 OHX • M530 OH6 • ARVEO • M720 OH5/OHC5 • M525 OH4/OHC4, F50/F40, C50/C40
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 9435 Heerbrugg Switzerland
• KINEVO 900 • TIVATO 700 • OPMI PENTERO 900 • OPMI PENTERO 800 • OPMI Pentero/Pentero C
Carl Zeiss Meditec AG Site Oberkochen Rudolf-Eber-Straße 11 73447 Oberkochen Germany
Additional surgical microscopes may become available after release of this manual. Contact Brainlab 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 adversely affect safety and/or effectiveness of the devices, and endanger safety of patient, user, and/or environment.
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1.6
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
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Training and Documentation
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MICROSCOPE INTERFACE CABLES
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MICROSCOPE INTERFACE CABLES
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 is established by a dedicated microscope integration cable. The navigation system can determine the viewing direction, the focus point, and the field of view diameter 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 Tracking Instrument User Guide.
Before Using Read the relevant Software User Guide before performing microscope navigation.
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Cables Overview
2.2
Cables Overview
Cables List
②
③
④
①
⑤
⑧
⑦
⑥
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
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
MICROSCOPE INTERFACE CABLE (ZEISS KINEVO 900)
15240
⑦
MICROSCOPE INTERFACE CABLE 4.0 (ZEISS KINEVO 900 15241-01 STEREO) ⑧
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MICROSCOPE INTERFACE CABLE 4.0 (ZEISS KINEVO 900/TIVATO 700) (shown)
15241-02
MICROSCOPE INTERFACE CABLE 4.0 (ZEISS)
15241-03
MICROSCOPE INTERFACE CABLE 4.0 (LEICA)
15241-04
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MICROSCOPE INTERFACE CABLES
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 Technical User Guide and/or the manufacturer's instructions for use for your microscope.
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Strain Relief
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
③
④
②
①
⑤ Figure 2
Step 1.
Put the hook and loop strap through the strain relief loops of the microscope cable, wrapping 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 Navigation (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 as Curve Navigation.
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MICROSCOPE INTERFACE CABLES
2.4
Cleaning
Before You Begin Ensure that the system is fully shut down and disconnected from mains power before beginning cleaning.
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 damage components.
No Liquids Ensure that liquids do not enter the system, as this could damage the component and/or the electronics.
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 disinfectants). 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.
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Cleaning
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LEICA MICROSCOPES
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LEICA MICROSCOPES
3.1
Connection to Curve 1.0
How to Connect Connect the supplied cables between the microscope ports and the corresponding ports on the Curve 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 hook and 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.
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Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted)
3.2
Connection to Curve 1.1 and 1.2 and Buzz Navigation (Ceiling-Mounted)
How to Connect Connect the supplied cables between the microscope ports and the corresponding ports on the navigation systems according to the following diagrams. NOTE: Secure any loose cables that hang from Curve to the base of the system with the hook and 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. 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 4 NOTE: It is recommended to use an HD-SDI connection if available.
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Hardware User Guide Rev. 1.0 Microscope Navigation
LEICA MICROSCOPES
3.3
Connection to Curve Ceiling-Mounted
How to Connect Connect the supplied cables between the microscope ports and the corresponding ports on the Curve Ceiling-Mounted system according to the following diagrams. NOTE: Secure any loose cables that hang from the Curve Ceiling-Mounted Connection Unit to the rail of the ceiling supply unit (CSU) with the hook and loop strap. 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 5
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