MOUNTED) (CEILING- NAVIGATION BUZZ - Brainlab User Guides

TABLE OF CONTENTS1 GENERAL INFORMATION.............................................................................................7

1.1 Contact Data ........................................................................................................................................7

1.2 Legal Information ...............................................................................................................................8

1.3 Symbols..............................................................................................................................................101.3.1 Symbols Used in This Guide .............................................................................................................10

1.4 Project-Specific Information ..........................................................................................................14

2 SYSTEM COMPONENTS ..............................................................................................15

2.1 System Components .......................................................................................................................15

2.2 Medical Computer Unit (MCU) .......................................................................................................182.2.1 Overview ...........................................................................................................................................182.2.2 MCU Ports .......................................................................................................................................19

2.3 Displays ..............................................................................................................................................222.3.1 42" Display .......................................................................................................................................232.3.2 CM Display/Additional CM Display ...................................................................................................24

2.4 CM Camera.........................................................................................................................................26

2.5 Connection Unit ................................................................................................................................29

2.6 Supply Unit ........................................................................................................................................32

2.7 Accessories .......................................................................................................................................332.7.1 Converter Box ..................................................................................................................................342.7.2 Patch Field .......................................................................................................................................352.7.3 Coupling Box....................................................................................................................................36

3 SYSTEM CONNECTIONS.............................................................................................37

3.1 Connections Overview ....................................................................................................................37

3.2 Third-Party Connections.................................................................................................................38

3.3 Wireless LAN Connection...............................................................................................................39

3.4 Potential Equalization Connection ...............................................................................................40

3.5 Power Outlets ....................................................................................................................................41

3.6 Cabling Options ................................................................................................................................423.6.1 Cabling Specifications for In-Arm Cables .........................................................................................45

TABLE OF CONTENTS

Site Planning Manual Rev. 1.3 Buzz Navigation (Ceiling-Mounted) Ver. 1.0 3

3.7 Connection Options .........................................................................................................................473.7.1 MCU Connection Options.................................................................................................................483.7.2 Connection Unit Options ..................................................................................................................533.7.3 42" Display and Feature Panel Connection Options .........................................................................563.7.4 Supply Unit Connection Options.......................................................................................................583.7.5 Tracking Camera Connection Options..............................................................................................593.7.6 CM Display Connection Options.......................................................................................................60

4 PLANNING..................................................................................................................................61

4.1 Planning Specifications ..................................................................................................................614.1.1 Overview ...........................................................................................................................................614.1.2 Recommended Locations ................................................................................................................63

4.2 System Specifications.....................................................................................................................714.2.1 Mechanical Specifications .................................................................................................................714.2.2 Physical Specifications.....................................................................................................................724.2.3 Electrical Specifications....................................................................................................................734.2.4 Environmental Conditions ................................................................................................................744.2.5 Hospital Network ..............................................................................................................................75

4.3 Mounting Options.............................................................................................................................764.3.1 42" Display On-Wall Mounting..........................................................................................................774.3.2 42" Display In-Wall ...........................................................................................................................784.3.3 Additional 42" Display On-Wall .........................................................................................................794.3.4 Additional 42" Display In-Wall...........................................................................................................804.3.5 Ceiling Superstructure and Substructure ..........................................................................................814.3.6 Connection Unit................................................................................................................................834.3.7 Supply Unit.......................................................................................................................................844.3.8 Medical Computer Unit.....................................................................................................................854.3.9 Converter Box ..................................................................................................................................864.3.10 Rack Installation.............................................................................................................................87

4.4 Electrical Outlets ..............................................................................................................................884.4.1 Configuration....................................................................................................................................90

4.5 MCU Rack Installation .....................................................................................................................92

4.6 Required Service Access to 42" Display.....................................................................................93

4.7 Ventilation ..........................................................................................................................................94

4.8 42" Display Ventilation ....................................................................................................................964.8.1 Overview ...........................................................................................................................................96

4.9 Magnetic Resonance (MR) Environment .....................................................................................98

5 REQUIREMENTS AND SPECIFICATIONS .................................................103

5.1 Requirements for Ceiling Arm Integration ................................................................................1035.1.1 Ceiling Supply Unit (CSU) ..............................................................................................................1065.1.2 Medical Computer Unit (MCU) .......................................................................................................108

TABLE OF CONTENTS

4 Site Planning Manual Rev. 1.3 Buzz Navigation (Ceiling-Mounted) Ver. 1.0

6 SITE PREPARATION .......................................................................................................109

6.1 Installation Requirements.............................................................................................................1096.1.1 On-Site Logistics .............................................................................................................................1096.1.2 Duct Work/Conduits ....................................................................................................................... 1116.1.3 Protective Earth Connections/Potential Equalization ......................................................................119

7 IMPLEMENTATION ...........................................................................................................121

7.1 General Time Line/Durations .......................................................................................................1217.1.1 Overview .........................................................................................................................................121

7.2 Project Phases ................................................................................................................................122

7.3 Scope of Customer Work..............................................................................................................124

8 APPENDIX ................................................................................................................................127

8.1 Appendix ..........................................................................................................................................127

TABLE OF CONTENTS


TABLE OF CONTENTS


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

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 trademark of Brainlab AG.• Buzz™ is a trademark of Brainlab AG.

Liability

The general descriptions and specifications in this guide do not in any way constitute a legallybinding representation or warranty. The information provided is subject to change without notice.No legal obligations exist, either on the part of Brainlab, the customer or any third-party withregard to the planning, sale, delivery, installation or operation of a Buzz Navigation (Ceiling-Mounted) system except as stipulated by duly executed written agreements between the partiesand any attachments thereto.NOTE: All pictures and drawings in this manual are NOT TO SCALE!

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 principles set out in the MDD, Buzz Navigation (Ceiling-Mounted) is a Class IIb product.

NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.

Certificates and Approvals

Buzz Navigation (Ceiling-Mounted) is certified according to:• IEC 60601-1:2005+A1:2012(3.1 Edition)• ANSI/AAMI ES60601-1:2005/(R)2012• CAN/CSA-C22.2 NO. 60601-1:14

Ingress Protection

The 42" Display is rated IP20 (front side IP54) according to IEC 529.The Ceiling-mounted Display is rated IP20 (front side IP54) according to IEC 529.

Perchlorate

For residents of the state of California, U.S.A., special handling may apply to perchloratematerials. For more information, visit: www.dtsc.ca.gov/hazardouswaste/perchlorate.For recycling instructions, please contact Brainlab.

Legal Information


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

http://www.dtsc.ca.gov/hazardouswaste/perchlorate

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.

GENERAL INFORMATION


1.3 Symbols1.3.1 Symbols Used in This Guide

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.

Symbols on Hardware Components

The below symbols may be found on the system.

Symbol Explanation

Type B Applied Part according to IEC 60601-1

Type BF Applied Part according to IEC 60601-1

Caution

Potential equalization point

Do not reuse

Non-Sterile

Do not resterilize

Symbols


Symbol Explanation

Sterilized with ethylene oxide

Do not use if packaging is damaged

Keep away from sunlight

Keep dry

Storage conditions for temperature: The specified temperature range is shown oneach label

Storage conditions for relative humidity non-condensing: The specified humidityrange is shown on each label.

Storage conditions for air pressure: The specified air pressure range is shown oneach label

Quantity of products in packaging

Batch number

Serial number

Article number

Use by month YYYY

Date of manufacture

Manufacturer

Authorized representative in the European Community

MR Conditional

GENERAL INFORMATION


Symbol Explanation

ETL/Intertek approval

Radio device

Risk of electrical shock

Class I Laser: Risk of injury due to laser radiation

(Vega Camera)Laser radiation emitted from apertureDo not stare into beamClass 2 laser productmax. output 1mW wavelength 635-670 nmANSI Z136.1 (2014), IEC 60825-1 (2014)FDA/CDRH 21 CFR 1040.10 and 1040.11 except for deviations pursuant toLaser Notice No. 50, dated June 24, 2007.

IPXX

Ingress Protection according to IEC 60529• 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.

Power button

Consult the operating instructions

Follow the instructions for use

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

Unique device identification

Symbols on Packaging

Symbol Explanation

Handle with care

Symbols


Symbol Explanation

Do not stack

This side up

Keep dry

Temperature limitNOTE: Indicates the temperature limits to which the medical device can be safelyexposed.

Humidity limitationNOTE: Indicates the range of humidity to which the medical device can be safely ex-posed.

Atmospheric pressure limitationNOTE: Indicates the range of atmospheric pressure to which the medical device canbe safely exposed.

GENERAL INFORMATION


1.4 Project-Specific Information

General Information

This guide covers standard information and general specifications. As project requirements varyfrom site to site, these specifications must be adapted accordingly. For the implementation of anyproject, a detailed site planning phase by Brainlab is necessary.

Purpose and Audience

This Site Planning Manual is intended as a reference for the effective and correct implementationof Buzz Navigation (Ceiling-Mounted). This guide is written for customers, in particularcustomers who have purchased or intend to purchase Buzz Navigation (Ceiling-Mounted), aswell as all members of the clinical, architectural, structural and consulting teams who are involvedin the planning and implementation of Buzz Navigation (Ceiling-Mounted) or parts of it. Itdescribes all information required to prepare the sites for on-wall and in-wall mounting, and ceilingmounting, including drawings.This guide is to be provided to all relevant parties at the beginning of the planning process andexplained in appropriate detail. Read this manual carefully and acquaint yourself sufficiently withthe system before planning its implementation.This Site Planning Manual contains important information about the responsibilities and duties ofall relevant parties. Pay special attention to the warnings and cautions provided in this manual.

Ceiling-Mounted Arm System

This guide contains specific information for suppliers of ceiling-mounted arms systems thatevaluates the compatibility of the arm system to Buzz Navigation (Ceiling-Mounted).Buzz Navigation (Ceiling-Mounted) requires a ceiling-mounted arm system in order to operatewithin its intended use. Brainlab does not offer or provide such a ceiling-mounted arm system.

Customer Responsibility

All structural preparations, such as reinforcement and/or strengthening for roof-mounted items,ceilings, superstructures, or any related objects are the responsibility of the customer.Additionally, it is the customer’s sole responsibility:• To identify and provide, at their own cost, a ceiling-mounted arm system from a third-party

supplier that allows a safe combination with Buzz Navigation (Ceiling-Mounted).• To ensure that the ceiling-mounted arm system meets all specifications and requirements, as

stated in this document.• To ensure that the ceiling-mounted arm system is installed and ready for the Buzz Navigation

(Ceiling-Mounted) installation by Brainlab at the mutually agreed installation date.

Technical Specifications

In the event of technical deviations from the specifications (related, for instance, to country-specific codes and standards), planning and execution must be reworked in order to fulfill allapplicable regulations.NOTE: The customer is responsible for notifying Brainlab of any necessary modifications that arerequired to meet applicable local or country-specific codes and regulations.

Safety Information

The Medical Computer Unit (MCU) of the Buzz Navigation (Ceiling-Mounted) is not tested inMR environment. Therefore, the Computer Unit must be placed outside the MR cabin when BuzzNavigation (Ceiling-Mounted) is used in combination with an intraoperative MR scanner.

Project-Specific Information


2 SYSTEM COMPONENTS2.1 System Components

General Information

Buzz Navigation (Ceiling-Mounted) can be used in a professional healthcare facilityenvironment for various surgical procedures involving video processing, image recording, patientdata viewing and software application control. It is suitable for continuous use during surgicalprocedures.Integrating the ceiling-mounted camera and display, and using suitable application software, BuzzNavigation (Ceiling-Mounted) is used as navigation station.

Essential Performance

As essential performance is defined by the clinical function(s), it is dependent on the Brainlabapplication used and the clinical procedure. Consult the corresponding Software User Guide tosee if an essential performance is defined, and if so, which essential performance.

Frequently Used Functions

The following are defined as the most frequently used Buzz Navigation (Ceiling-Mounted)hardware functions:• Positioning prior to surgery• Activation of laser pointer for positioning• Startup/shutdown• Non-sterile repositioning of ceiling-mounted components during surgery• Sterile use of ceiling-mounted components during surgery• Cleaning of switched-off device• Connecting/unplugging third-party devices• Transferring patient data to the device• Sterile and unsterile interacting with application software

Buzz Navigation (Ceiling-Mounted) Components

Buzz Navigation (Ceiling-Mounted) (article number 15706) comprises the followingcomponents:

Component Description

Medical Computer Unit(MCU)

Processes data that can be displayed on a connected display or pro-vided at interface connections at the MCU user or connection panel,Feature Panel or Connection Unit.

42" Display Provides interaction with Brainlab software. Available as In- or On-Wall variant.

SYSTEM COMPONENTS


Component Description

Ceiling-mounted (CM)Display

Display unit to display the navigation, including touch functionality foruser to interact with the software. This is the main display for image-guided surgery.

Ceiling-mounted (CM)Camera An optical tracking system (camera on a camera joint).

Connection Unit

An optional device used for extending the interfaces available on theMCU. As the MCU is located outside the OR, the Connection Unit isnecessary, (e.g., for connection of third-party devices such as the mi-croscope, ultrasound, or c-arm that are available inside the OR). TheConnection Unit provides interfaces for data, video input and videooutput.

Supply UnitProvides electric power (DC) to the CM Display and CM Camera. Italso converts optical fiber Ethernet connection from the MCU to cop-per-based Ethernet connection to the CM Camera.

Feature Panel Enables monitoring, control and interaction with the MCU.

WarningDo not place objects on Buzz Navigation (Ceiling-Mounted) components.

Illustration

⑤

②① ③④

No. Description

① Additional (optional) 42" Display

② 42" Display

③CM DisplayNOTE: An additional (optional) CM Display is possible instead of Additional 42" Dis-play.

④ CM Camera

System Components


No. Description

⑤ Connection Unit

Related Links

Medical Computer Unit (MCU) on page 1842" Display on page 23CM Display/Additional CM Display on page 24Connection Unit on page 29Supply Unit on page 32Accessories on page 33

SYSTEM COMPONENTS


2.2 Medical Computer Unit (MCU)2.2.1 Overview

General Information

The Medical Computer Unit (MCU) processes data that can be displayed on a connected displayor provided at interface connections at the MCU user or connection panel, feature panel orConnection Unit.

MCU

①

Figure 1

No. Component

① MCU

MCU Location

The MCU must be located outside the OR, (e.g., in a control room rack).Optical transfer lines are used to connect MCU and display over a distance up to 100 m.

Medical Computer Unit (MCU)


2.2.2 MCU Ports

User Panel

Multiple third-party video connections are possible at the same time.

②

①

④

③

⑤

⑥

⑨

⑧⑦

⑩

Figure 2

No. Component

① CD/DVD drive

②Analog Video Input• 1 x S-video IN• 1 x Composite IN

③ 2 x SDI Video Inputs

④

Imaging Output for Microscope• 1 x DVI-I Out• 1 x USB B

NOTE: This video output may also be used for a display that can be connected by theuser (e.g., a projector).

The USB Type B connector at theMCU User Panel is explicitly for connectingthe Brainlab Microscope Cable. Connecting other devices to this interfacemight damage the devices or the MCU.

⑤ 2 x DVI Video Inputs

⑥

Power connections for transfer line components• 6 x 5V DC / 2A

NOTE: Only connect equipment specified by Brainlab.

⑦Network Connection• Tracking Unit/Camera• Intraoperative Data/Navigation

⑧Data ports2 x USB 3.0

⑨ Computer power button with status LED

⑩ Mains power LED

SYSTEM COMPONENTS


User Panel: Occupied Ports

The black rectangles in the illustration show which ports are typically reserved for connections tothe Connection Unit and CM Camera. Different configurations are possible:

②①

③

① ①

Figure 3

No. Component

① Connection Unit

② CM Camera

③ 3 connections occupied

Back Connection Panel

③

①

⑤④ ⑥ ⑧

⑪

②

⑦

⑩

⑨

Figure 4

No. Component Can be Used By

① Mains Switch Trained user

② Mains Power Inlet Trained user

③ Potential equalization Trained user

④ Network/USB 2.0 to Feature Panel Brainlab support

⑤ Hospital Network (1 GbE) Brainlab support

⑥ Hospital Network (10 GbE) - Not in use Brainlab support

MCU Ports


No. Component Can be Used By

⑦

Audio In / Out• Microphone In• Audio In• Audio Out

Brainlab support

⑧ Video Output and USB 2.0 for Display 1 - 4 Brainlab support

⑨ Video Output for Display 5 Brainlab support

⑩

Power connections for transfer line components4 x 5 V DC / 0.5 A eachNOTE: Only connect equipment specified by Brainlab to theDC output.

Brainlab support

⑪ 2 x USB 3.0 Brainlab support

Back Connection Panel: Occupied Ports

The boxes in the illustration show which ports are typically reserved for connections to other BuzzNavigation (Ceiling-Mounted) components. Different configurations are possible:

③①

⑤

④

⑥

②

Figure 5

No. Component

① Feature panel

② 42" Display

③ CM Display

④ Additional 42" Display (optional) or additional CM Display (optional)

⑤ 3 x (+ 1 optional for additional display)

⑥ Connection Unit

SYSTEM COMPONENTS


2.3 Displays

General Information

The 42" Display (On-Wall / In-Wall) and CM Display enables interaction with Brainlab softwareapplications.Viewing options vary depending on the software application and user preferences. For moreinformation, see the relevant Software User Guide.The display is highly precise and fragile electrical equipment. Handle it carefully.When the system is running, the displays are always on and can be used.

Touch Display Use

Regardless of the number of touch displays connected to the Buzz Navigation (Ceiling-Mounted), only one interaction can be performed and is recognized at a time.

Control

Optionally, displays can be switched off/on separately (e.g., through a room control for MR scans).

Positioning

Position ceiling-mounted display so as to not interfere with surgery or movement of the OR staff.

Not for Diagnostic Use

WarningThe 42" Display and the CM Display do not comply with DIN EN 6868 and are not intendedfor diagnostic use.

Displays


2.3.1 42" Display

42" Display and Feature Panel

① ②Figure 6

No. Component

① 42" Display

② Feature panel

Display Variants

Location Description

In-Wall The 42" Display is integrated in the wall

On-Wall The 42" Display is attached to the surface ofthe wall

Additional Touch Display (Optional)

The Buzz Navigation (Ceiling-Mounted) can optionally be installed with an additional 42"Display.

①Figure 7

No. Component

① Additional touch display

Power Outlet

The main 42" Display and each additional 42" Display requires one power outlet.

SYSTEM COMPONENTS


2.3.2 CM Display/Additional CM Display

General Information

WarningDo not place objects on the ceiling-mounted components.

Display Components

①

Figure 8

No. Component

① Touchscreen

Range of Motion

The range of motion greatly depends on the arm system installed. See the user guide of the armsystem manufacturer for more information.

CM Display Dimensions

①Figure 9

CM Display/Additional CM Display


No. Component

①4 x M4Screw length in display 22-24 mm

SYSTEM COMPONENTS


2.4 CM Camera

General Information

Do not place any transparent or semi-transparent materials (such as foil or glass) betweencamera and tracked instruments.Highly reflective items or sources of light obstruct the camera’s view. Artifacts caused byreflections can reduce accuracy, especially during registration.The positioning laser of the CM Camera is a Class 2 laser module and has a warning label. Donot cover the warning label connecting to an arm system.

WarningDo not place objects on the Ceiling-Mounted components.

CM Camera Components

⑤

②

①

③④

Figure 10

No. Component

① Camera handle

② Positioning laser

③ Illuminator filter

④ Lens

⑤ Laser trigger

CM Camera


Camera Field of View

Position the camera so that the operating field is in the center of the camera field of view. Optimalworking distance is 1.2 to 1.8 m from the camera to the operating field.If instruments are not in the camera field of view, they cannot be tracked.The navigation software displays the camera field of view dialog (see Software User Guide) andhelps you to determine the best camera position.

Figure 11

The camera must not be protected or covered with methods not approved by Brainlab. Donot obstruct the normal air flow around the camera, for example, by draping or bagging thecamera. Doing so will affect the camera’s operational environment, possibly beyond itsrecommended thresholds.

SYSTEM COMPONENTS


CM Camera Dimensions

416.

6591.2

190.7

Figure 12

Related Links

Physical Specifications on page 72

CM Camera


2.5 Connection Unit

General Information

The Connection Unit is used for extending the interfaces available on the MCU. As the MCU islocated outside the OR, the Connection Unit is necessary for connection of third-party devices(e.g., the microscope, ultrasound device, or c-arm) that are available inside the OR. TheConnection Unit provides interfaces for data, video input and video output.

Connection Unit Front Connections

②① ③ ④

Figure 13

No. Component

①Navigation Imaging:• 2 x 3G-SDI In• DVI-D In

②Data:• USB 2.0• 2 x Intraoperative Data (LAN, shared 1 Gbit/s)

③

Microscope:• Communication 1: USB-B• Communication 2: Ethernet• Head-Up Display (HUD) 1: DVI-A• Head-Up Display (HUD) 2: DisplayPort (DP)

④ Status LED

Status LED

LED Status Connection Unit Status

Off Connection Unit turned off/unpowered

Green Connection Unit running

SYSTEM COMPONENTS


Connection Unit Rear Connections

① ② ③ ④

Figure 14

No. Component

①

Fiber optic connections:• SDI 1 and 2• USB• DVI In 1• IntraOP Data• DP3 and DVI Out (Mic)• 3 x Spare

②5V DC / 2 A24 V DC / 0.5 ACovered when not in use

③ Potential equalization

④ Power

Power Supply

The Connection Unit requires one power outlet.

Connection Unit Dimensions

8990.2

Connection Unit


381

377

Figure 15

Related Links


SYSTEM COMPONENTS


2.6 Supply Unit

General Information

The Supply Unit provides electric power (DC) to the CM Display and the CM Camera. It alsoconverts optical fiber Ethernet connection from the MCU to copper-based Ethernet connection tothe CM Camera.The Supply Unit requires one power outlet.

Supply Unit Dimensions

Figure 16

Related Links


Supply Unit


2.7 Accessories

General Information

Accessories for the installation:• Converter box• Patch field• Coupling box

Related Links

Converter Box on page 34Patch Field on page 35Coupling Box on page 36

SYSTEM COMPONENTS


2.7.1 Converter Box

General Information

The Converter Box houses, organizes, manages and protects Buzz Navigation (CeilingMounted) converter connections.

Dimensions

Figure 17

Converter Box


2.7.2 Patch Field

General Information

The rack mountable Patch Field houses, organizes, and protects fiber optic connections.

Description

Figure 18

Width 482.6 mm

Height 44 mm

Depth 194.98 mm

SYSTEM COMPONENTS


2.7.3 Coupling Box

General Information

The Coupling Box is a distribution box for mounting in drywall installations. It is suitable to insertfiber cables for proper installation and comes with cable entries and cable reliefs.

Description

Figure 19

Width 260 mm

Height 332 mm

Depth 60 mm

Coupling Box


3 SYSTEM CONNECTIONS3.1 Connections Overview

Before You Begin

Read all user guide documentation carefully before connecting any equipment to BuzzNavigation (Ceiling-Mounted).

Mains Power Cables

The mains power cables may only be exchanged by Brainlab or authorized service personnel.Do not tug or pull at cables when establishing or opening a connection, but always pull at theconnector. Otherwise, the interface or connector might be broken and live parts becomeaccessible.Ensure that there is sufficient slack when connecting cables. Do not strain or place the attachedcables under tension.Attach cables carefully, ensuring that no one will trip over them.

Restrictions Connecting Equipment to Panels

WarningOnly connect equipment that is specified by Brainlab or where Brainlab claimscompatibility with the Buzz Navigation (Ceiling-Mounted) to the device.Buzz Navigation (Ceiling-Mounted) is not intended for real-time video distribution. A real timecritical source, (e.g., an endoscope), must remain directly connected to its dedicated display oroptical system.For critical applications, it must be possible to make information available independently of BuzzNavigation (Ceiling-Mounted), (e.g., bypassing Buzz Navigation (Ceiling-Mounted) andconnecting the signal directly to a monitor).

WarningAdditional equipment connected to medical electrical equipment must comply with therespective IEC or ISO standards (e.g., IEC 60950 for data processing equipment andIEC60601-1 for medical equipment). Furthermore, all configurations shall comply with therequirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rdedition of IEC 60601-1, respectively). Anyone connecting additional equipment to medicalelectrical equipment configures a medical system and is therefore responsible that thesystem complies with the requirements for medical electrical systems. Please note thatlocal laws take priority over the above-mentioned requirements. If in doubt, consult yourlocal representative or the technical service department.

WarningConnecting electrical equipment to multiple socket outlets effectively leads to creating anME SYSTEM, and can result in a reduced level of safety.

SYSTEM CONNECTIONS


3.2 Third-Party Connections

General Information

Buzz Navigation (Ceiling-Mounted) detects newly connected video signals. All connected videoinput and output sources are shown in Content Manager. If a source does not appear, selectRefresh in Content Manager. For more information, see the Content Manager Software UserGuide.Despite certain video signal types being generally supported, it is possible that some devices arenot compatible with Buzz Navigation (Ceiling-Mounted). If you are unsure of a device’scompatibility, contact Brainlab support.An external (optional) 3D display must support 3D line-by-line technology to display 3D contentcorrectly.

MCU LAN Connection

Connecting Buzz Navigation (Ceiling-Mounted) to the hospital network offers:• The transfer of patient data from or to the system.• Remote access of information displayed on the display.• The possibility to stream, record and share a session depending on the Brainlab application

running on the device and the integration into the hospital network.Only connect IEC-compliant devices to the LAN ports.

USB Connections

Scan USB flash drives with an antivirus software before connecting them to the system.

WarningOnly connect bus-powered (low-power or high-power) devices compliant to the USB 1.x,2.0 or 3.0 specification or specifically released devices to Buzz Navigation (Ceiling-Mounted). Bus-powered devices must not draw more power than 500mA (USB 2.0) or900mA (USB 3.0) according to the USB specification.Do not connect self-powered USB devices to Buzz Navigation (Ceiling-Mounted). Self-powered devices are USB-devices that are externally powered by a separate power supply.Otherwise the safety and effectiveness of the equipment cannot be guaranteed.

Third-Party Connections


3.3 Wireless LAN Connection

Wireless LAN Compliance

Buzz Navigation (Ceiling-Mounted) is compliant with the following:• CE• FCC• IC

The WLAN module included in this product cannot be accessed by the end users. The FCC IDand IC ID of the WLAN module can be found on the label. Please contact Brainlab Support incase of any related questions.The wireless device to which the Buzz Navigation (Ceiling-Mounted) shall be connected mustcomply with the standard IEEE 802.11 a/b/g/n.NOTE: Wireless features may be disabled in accordance with local restrictions or pendingapproval. Contact Brainlab support for more information.

NOTE: If there is a bad, or no, wireless connection, use a cable connection (LAN cable).

NOTE: The antenna of the WLAN module is behind the Feature Panel glass close to the speaker.A distance of 20 cm should be maintained between the WLAN antenna and the user.

WarningOnly operate the system in secured network environments.

SYSTEM CONNECTIONS


3.4 Potential Equalization Connection

General Information

The function of the potential equalization conductor is:• To equalize potentials between different metal parts that can be touched simultaneously.• To reduce differences of potential that can occur between medical electrical devices and

conductive parts of other objects during operation.NOTE: A potential equalization connection to the system is optional. When connecting a potentialequalization conductor, an ME System is created.

How to Connect Potential Equalization Cables

Perform this task before using the system and while the system is still turned off.

Potential Equalization Pins (POAG)

Medical Computer Unit

Connection Unit

Step

1. Plug potential equalization cable into potential equalization port on the Medical ComputerUnit.

2. Connect potential equalization cable to an equivalent wall outlet or an equipotential bond-ing terminal.

3. Plug potential equalization cable into potential equalization port on the Connection Unit.

4. Connect potential equalization cable to an equivalent wall outlet or an equipotential bond-ing terminal.

Potential Equalization Connection


3.5 Power Outlets

Separate Outlets

These components of a Buzz Navigation (Ceiling Mounted) installation need separate poweroutlets.

Component Outlet Location Power Cable Length Comment

42" Display In-wall /On-wall

Next to main 42” Dis-play >1.7 m

Supply Unit for CMDisplay and CM Cam-era

Next to main 42” Dis-play >1.7 m

Connection Unit Next to ConnectionUnit >1.7 m

MCU Next to MCU >1.7 m

Network ConverterTracking Unit Next to Converter Box >1.7 m

Wall plug transformersrequire extra spacearound power outletdepending on country-specific adapters.

Network Converter In-traoperative Data Next to Converter Box >1.7 m


Network ConverterFeature Panel Next to Converter Box >1.7 m


Optional Additional 42" Display

Additional 42" DisplayIn-wall / On-wall Next to display >1.7 m

SYSTEM CONNECTIONS


3.6 Cabling Options

General Information

All cabling for a standard set-up is shipped with the product. External cabling needed for third-party device integration is not described here.

Short Distance Cabling

These cables are used inside control or equipment room between MCU, converters on the MCUor Converter Box and the Patch Field.To allow flexibility the cabling from the converters or from the Converter Box to the Patch Fieldcome in different lengths.

Cabling Description

Fiber cable options• 2 m and 3 m patch cable set for rack installa-

tion• 5 m cable set

Other Cables in the control room

Cabling required for:• Converter• Power• Hospital network• Optional video

Long Distance Cabling

Long distance fiber optic cabling is used, for example, inside the ceiling and between the MCU(control room) and the operating room. For flexibility, six cable options are available:• Fiber Cable MTF-12 10 m• Fiber Cable MTF-12 20 m• Fiber Cable MTF-12 30 m• Fiber Cable MTF-12 50 m• Fiber Cable MTF-12 70 m• Fiber Cable MTF-12 100 m

If you choose to use customer cabling, it must comply with these specifications:• Optical fiber OM4 50/125 µm containing 12 fibers with MTP connectors (female) at both ends• Amount of fiber line per connection: see table below

Amount of fibers Cable from Cable to Cable Length

1 Patch field PC Side Main 42" Display ORSide Custom up to 100 m

Additional 42" Display (optional):

1 Patch field PC Side Additional 42" DisplayOR side Custom up to 100 m

Additional CM Display (optional):

1 (only if an additional42” Display is not in-stalled, otherwise 0)

Patch field PC Side Additional CM DisplayOR side Custom up to 100 m

The fiber cables to the display should at least protrude 1 meter from the conduit opening behindthe display (main and additional 42" Display).The fiber cables connected to the Patch Field and to the Coupling Box should reach the devicewith little margin.

Cabling Options


The cables to the patch field must have enough length from the conduit opening. The usage offiber sockets is possible. Only connect the fiber directly to an optional fiber socket without furtherfiber interconnection points.Ensure that the customized cables are tested and documented for Brainlab service before BuzzNavigation (Ceiling-Mounted) installation.Ensure that the cabling is secured against dirt and dust and mechanic impact until final BuzzNavigation (Ceiling-Mounted) installation.

Cabling Inside the Operating Room

Cabling from the main 42" Display to the ceiling-mounted components:• Ethernet and PE cable Buzz CM Camera CM Display cable bundle• CM Display ceiling 11 m• CM Display Ceiling to Display 8 m

Cabling from coupling box to the Connection Unit:• Fiber cable 8m for Buzz Connection Unit• 1. Cable Gland Option: 1 x 63 mm with 3 grommets and 1 dummy

• 2. Cable Gland Option: 2 x 50 mm with 3 grommets and 1 dummy

NOTE: Cable gland is used for Ceiling Supply Unit cable entry.

Cabling to Connection Unit:• Power cabling

SYSTEM CONNECTIONS


• Optional video cabling (e.g., microscope, ultrasound, c-arm)

Related Links

Power Outlets on page 41

Cabling Options


3.6.1 Cabling Specifications for In-Arm Cables

General Information

The minimum bending radius for the fiber optic cables is 40 mm.Buzz Navigation (Ceiling-Mounted) contains several cable bundles. The number of theindividual cable bundles depends on the variant.

Cable Bundle 15700-91 (11 m)

For the CM Display, this cable bundle consists of the following cables covered by a fabric tube:• 2 x FOs including plugs and connectors• 1 x power cable (with two wires plus shield), including connector at both ends

Details:• Each FO plug is 11 x 13 mm (FO plug cannot be removed)• Connectors at the power cable can be removed for assembly• Cable bundle diameter is approximately 14 mm• For Buzz Navigation (Ceiling-Mounted), one cable bundle is required• One FO is a spare part

Figure 20

NOTE: Both ends of cable bundle are identical.

Cable Bundle 15700-93 (8 m)

This cable bundle is run through the arm system.For the CM Display, this cable bundle consists of the following cables covered by a fabric tube:• 2 x FOs including plugs• 1 x power cable (two wires plus shield), including connector at the both ends• 1 x protective earth cable (4 mm²)

Details:• Each FO plug is 11 x 13 mm (FO plug cannot be removed)• Connectors at the power cable can be removed for assembly• Fabric tube can be removed• Protective earth cable must be connected to the protective earth terminal.• Cable bundle diameter is approximately 14 mm• One FO is a spare part

SYSTEM CONNECTIONS


① ②

Figure 21

No. Component

①Front end including connectors for the power cableNOTE: The protective earth cable must be connected to the protective earth terminal(provided by customer).

② Back end including connectors for the power cable

Flexible Ethernet and PE-Cable 15895 (20m / 8m)

This cable bundle is run through the arm system.The cable bundle for the CM Camera consists of the following cables and is covered by a fabrictube:• 1 Ethernet cable including plugs• 1 protective earth cable

Details:• PE cable 8 m length (4 mm²)• Ethernet cable 20 m length (AWG25)• Diameter of the cable bundle is approx. 15 mm• Diameter of the Ethernet plug is approx. 16 mm• Fabric tube can be permanently removed

Figure 22

Cabling Specifications for In-Arm Cables


3.7 Connection Options

General Information

There are several variations in how the system components can be connected to each other andto third-party devices. There are also options in which cables to use.

Related Links

MCU Connection Options on page 48Connection Unit Options on page 5342" Display and Feature Panel Connection Options on page 56Supply Unit Connection Options on page 58Tracking Camera Connection Options on page 59CM Display Connection Options on page 60

SYSTEM CONNECTIONS


3.7.1 MCU Connection Options

Power and Data Connections

The table describes the different options for connections to and from the MCU.Where the cable is marked in italic, you can choose between different cable options.

Set Up Type Connection From via To Cabling

Power Power AC Mains MCU AC Input Power socket Country specif-ic power cord

Power Power DC DC Plug MCU DC OutDP TransmitterDC In

DC Power DPDVI TL

Power Power DC DC Plug MCU DC OutDVI TransmitterDC In

DC Power DPDVI TL

Power Power DC DC Plug MCU DC OutDVI ReceiverDC In

DC Power DPDVI TL

Hospital Net-work

Network /Ethernet RJ45 MCU Hospital

NetworkHospital Net-work

Short Ethernetcable

Feature Panel Network /Ethernet RJ45 MCU Feature

PanelPatch FieldConverter Box

Touch DisplayFeature Panel

Short EthernetcableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancePatch OM3 fi-ber

Network Con-nection Unit

Network /Ethernet RJ45 MCU Intra OP

Data

Coupling BoxPatch FieldConverter Box

ConnectionUnit

Short EthernetcableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

Tracking Unit /Camera

Network /Ethernet RJ45 MCU Tracking

Unit / Camera

Supply UnitPatch FieldConduitConverter Box


Short EthernetcableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

MCU Connection Options



Microscope In-tegration Con-trol

Data USB Connec-tion Unit USB Display 2


ConnectionUnitMicroscope In-tegration

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

Touch DisplayWall Data USB USB Display 1

Patch FieldConverter Box

Touch Display

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancePatch OM3 fi-ber

Touch CM Dis-play Data USB USB Display 3


CM Display

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC Coupler11 m Fiber+ 8 m Fiber

Optional Connections

AdditionalTouch Display Data USB USB Display 4


AdditionalTouch Display

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancePatch OM3 fi-ber

DC Power (7) Power DC DC Plug MCU DC Out Additional Pow-er Sink DC Power

SYSTEM CONNECTIONS


Video Input


Microscope In-tegration Video Input Up to 3G-SDI MCU SDI In 1


ConnectionUnitMicroscope In-tegration VideoIn

SDI CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

Microscope In-tegration Ster-eo

Video Input Up to 3G-SDI MCU SDI In 2Coupling BoxPatch FieldConverter Box

ConnectionUnit Micro-scope Integra-tion Video InStereo


Ultra Sound In-tegration Video Input

DVI Input 1ConnectionUnit

MCU DVI In 1Coupling BoxPatch FieldDVI Receiver

ConnectionUnit(e.g., UltraSound) Video In

Short distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

Optional Video Input

Video Input onConnectionUnit

Video Input Up to 3G-SDI MCU SDI In 2Coupling BoxPatch FieldConverter Box

ConnectionUnit(e.g., Endo-scope Video In)


Video Input onMCUSDI In

Video Input Up to 3G-SDI MCU SDI In 2

SDI Source(e.g., RoomCam, VideoMatrix)

Cover SDI In 2Port on Con-nection Unit.Cabling fromVideo Sourceto MCU.

Video Input onMCU DVI In Video Input DVI Input 2 MCU DVI In 2

Optional DVISource (e.g.,DVI Matrix)

Cabling fromVideo Sourceto MCU.

Video Input onMCUS-Video In

Video Input S-Video Input MCU S-videoIn

Optional S-vid-eo Source(e.g., UltraSound)





Video Input onMCU Compo-site In

Video Input Composite In-put

MCU Compo-site In

Optional Com-posite Source(e.g., c-arm)


Video Output / Display


Touch Display Video Out DisplayPort MCU Display 1Coupling BoxPatch Field

Touch Display

Short distancePatch OM3 fi-berLong distancefiberLC-LC Coupler1 m short fibercable

CM Display Video Out DisplayPort MCU Display 3Coupling BoxPatch Field

CM Display

Short distancePatch OM3 fi-berLong distancefiberLC-LC Coupler11 m + 8 m fi-ber

Microscope In-tegrationHUD 2

Video Out DisplayPort MCU Display 2Coupling BoxPatch FieldDP Transmitter

ConnectionUnitMicroscope In-tegrationHUD 2



Video Out DVIMCU Display(Microscope)

Coupling BoxPatch FieldDVI Transmitter



Optional Video Out / Additional Display

Additional Dis-play Video Out DisplayPort MCU Display 2

Patch FieldDP Transmitter

Additional Dis-play

Cover DP Outon ConnectionUnit.Cabling fromAdditional Dis-play to MCU.

SYSTEM CONNECTIONS



Touch Display Video Out DisplayPort MCU Display 4Patch FieldDP Transmitter

AdditionalTouch Display

Short distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancePatch OM3 fi-ber

Additional Dis-play Video Out DVI

MCU Display 5Additional Dis-play

Patch FieldDVI Transmitter

Additional Dis-play

Cabling fromAdditional Dis-play to MCU.

Related Links

Cabling Options on page 42



3.7.2 Connection Unit Options

Power and Data Connections

The table describes the different options for connections to and from the Connection Unit.Where the cable is marked in italic, you can choose between different cable options.


Power Power AC Mains ConnectionUnit Power socket Country specif-

ic power cord

Network Con-nection Unit

Network /Ethernet RJ45

ConnectionUnit Intraopera-tive Data 1 & 2,MicroscopeCommunication2

Converter BoxPatch FieldCoupling Box

MCU Intra OPData

Medium dis-tance 8 m fiberLC-LC CouplerLong distancefiberShort distancePatch OM3 fi-berShort EthernetCable

Microscope In-tegration Con-trol & PatientData

Data USB Connec-tion Unit

ConnectionUnitMicroscope In-tegration, USBData


MCU USB Dis-play 2

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8 m fiber

Video Input Options


Microscope In-tegration Video Input Up to 3G-SDI

ConnectionUnitNavigationImagingSDI 1 In


MCU SDI In 1

Medium dis-tance 8m fiberLC-LC CouplerLong distancefiberShort distancePatch OM3 fi-berSDI Cable


Video Input Up to 3G-SDI



MCU SDI In 2


SYSTEM CONNECTIONS




Video Input DVI

ConnectionUnitNavigationImagingDVI In

Patch FieldCoupling Box

MCU DVI In 1

Medium dis-tance 8m fiberLC-LC CouplerLong distancefiberShort distancePatch OM3 fi-berDVI Receiver

Optional Video Input

Video Input Video Input Up to 3G-SDI



MCU SDI In 2


Video Input onMCU

Video Input onMCU Up to 3G-SDI


Not used. Not used.

Cover SDI In 2Port on Con-nection Unit.Cabling fromVideo Sourceto MCU.

Video Input onMCU Video Input DVI

ConnectionUnitNavigationImagingDVI In

Not used. Not used.

Cover DVI InPort on Con-nection Unit.Cabling fromVideo Sourceto MCU.

Video Output / Display Options



Video Out DVI



MCU Display(Microscope)

Short distancePatch OM3 fi-berLong distancefiberLC-LC CouplerMedium dis-tance 8m fiber


Video Out DisplayPort


DP TransmitterPatch FieldCoupling Box

MCU Display 3

Medium dis-tance 8m fiberLC-LC CouplerLong distancefiberShort distancePatch OM3 fi-ber

Option Additional Display

Connection Unit Options



Additional Dis-play Video Out DisplayPort


Not used. Not used.

Cover DPHUD2 Port onConnectionUnit.Cabling fromAdditional Dis-play to MCU.

Related Links


SYSTEM CONNECTIONS


3.7.3 42" Display and Feature Panel Connection Options

Connections

The table describes the different options for connections to and from the 42" Display and FeaturePanel.Where the cable is marked in italic, you can choose between different cable options.


Power Power AC Mains Feature PanelTouch Display (Mains Switch) Power socket Country specif-

ic power cord

Feature Panel Network /Ethernet RJ45 Feature Panel

Touch DisplayConverter BoxPatch Field

MCU NetworkFeature Panel

Short EthernetcableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancefiber 1 m

Touch Display Data USB Touch Touch DisplayPatch FieldConverter Box

MCU USB Dis-play 1

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancefiber 1 m

Touch Display Video Out DisplayPort Touch DisplayPatch FieldDP Transmitter

MCU Display 1


Optional Additional Touch Display

OptionalPower

Power AC Mains AdditionalTouch Display (Mains Switch) Power socket Country specif-

ic power cord

Optional Addi-tional TouchDisplay

Data USB Touch AdditionalTouch Display


MCU USB Dis-play 4

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancefiber 1 m

AdditionalTouch Display Data Power Control Additional

Touch Display Touch Display Power ControlLine 25 m

42" Display and Feature Panel Connection Options



Touch Display Video Out DisplayPort AdditionalTouch Display

Patch FieldDP Transmitter

MCU Display 4


Related Links


SYSTEM CONNECTIONS


3.7.4 Supply Unit Connection Options

Connections

The table describes the different options for connections to and from the Supply Unit.Where the cable is marked in italic, you can choose between different cable options.


Power Power AC Mains Supply Unit Power socket Country specif-ic power cord

Tracking Data Network Ethernet Supply UnitPatch FieldConverter Box

MCU TrackingUnit / Camera

Short EthernetcableShort distancePatch OM3 fi-berLong distancefiberLC-LC CouplerShort distancefiber 1 m


Network / Pow-er Ethernet / DC Supply Unit Arm system Tracking Unit /

Camera

Vega NetworkCable 20 m +Power OverEthernet

CM Display Power DC Power Supply Unit Arm system CM Display 11 m + 8 m DCPower Cable

CM SystemPower Data Power Control Supply Unit Feature Panel RB Control

Line 0,7 m

Related Links


Supply Unit Connection Options


3.7.5 Tracking Camera Connection Options

Connections

The table describes the different options for connections to and from the tracking unit.



Network / Pow-er Ethernet / DC Tracking Cam-

era Arm system Supply Unit

Vega NetworkCable 20 m +Power OverEthernet

PE Camera Grounding PE Tracking Cam-era Arm system Ceiling Plate

Grounding PE Cable 8 m

Related Links


SYSTEM CONNECTIONS


3.7.6 CM Display Connection Options

Connections

The table describes the different options for connections to and from the CM Display.Where the cable is marked in italic, you can choose between different cable options.


Tracking Unit /Camera Power DC Power CM Display Arm system Supply Unit 11 m + 8 m DC

Power Cable

PE CM Display Grounding PE CM Display Arm system Ceiling PlateGrounding PE Cable 8 m

Touch Display Data USB Touch CM DisplayPatch FieldConverter Box

MCU USB Dis-play 3

USB CableShort distancePatch OM3 fi-berLong distancefiberLC-LC Coupler11 m + 8 m Fi-ber Cable

Touch Display Video Out DisplayPort CM DisplayPatch FieldDP Transmitter

MCU Display 3

Short distancePatch OM3 fi-berLong distancefiberLC-LC Coupler11m + 8m FiberCable LC-LCCoupler

Related Links


CM Display Connection Options


4 PLANNING4.1 Planning Specifications4.1.1 Overview

Patient Environment

The patient environment is defined as a distance of 1.5 m [4'11"] around the patient table and2.5 m [8'2.43"] above the OR floor.

Figure 23

WarningDo not position any Buzz Navigation (Ceiling-Mounted) component close to the sterile field.

Layout Design Parameters

The Connection Unit, CM Display, 42" Display and CM Camera are installed inside the OR. Thesecomponents are designed for positioning inside the patient environment.The Connection Unit is ideally placed near to the integration devices (e.g., microscope). It can beplaced onto a Ceiling Supply Unit.The MCU must be positioned outside the operating room. The location of the MCU must bedefined at the beginning of the site planning process.

PLANNING


The customer is responsible for providing sufficient space to access all Brainlab components formaintenance. Brainlab validates the location together with the local experts during the siteplanning process.Additionally, consider that the height of the camera and display(s) depends on the followingparameters:• Ceiling structure height• Substructure height• Type of arm system

Location Parameters

For finding the best possible location within an existing or a newly planned hospital, the followingparameters influence the final decision:• Laminar air flow field• Structural/static information• Types of surgical procedures to be performed

Detailed investigation and analysis will be carried out by the Brainlab representatives.NOTE: The power cables for the CM Display are 11 m + 8 m in length and for the CM Camerahave a maximum length of 20 m.

Special Requirements for Spinal Applications

To use the system for spinal applications with a CT scanner, make sure that the camera can beextended beyond both ends of the patient table. This requires exact planning of the BuzzNavigation (Ceiling-Mounted) central axis.

Third-Party Specifications

It is the customer's responsibility to ensure that additional components connected to medicalelectrical equipment comply with the respective IEC or ISO standards.

Planning Specifications


4.1.2 Recommended Locations

Setup (without Additional Displays): Top View

① ②

③

Figure 24

PLANNING


Diagram Text

This is the text in the illustration above:

No. Description

①/②Equipment room/technical room (adjacent to operating room)(Alternative location can be considered outside patient environment. To be discussedat planning stage)

③ Operating room

Color Description

(blue) Delivery and mounting by Brainlab

(orange) Delivery by Brainlab; mounting by builder/customer

(red) Delivery and mounting by builder/customer

(gray) Existing structure

Brainlab equipment (delivery and mounting):

Buzz Navigation (Ceiling-Mounted)

BN.1 Operating Room 42" Display In-Wall (incl. Supply Unit)

BN.2 Operating Room CM Camera

BN.3 Operating Room CM Display

BN.4 Operating Room Connection Unit

BN.5 Operating Room Coupling Box

BN.6 Technical Room MCU

BN.7 Technical Room Converter Box (Transfer Line Converter)

BN.8 Technical Room Patch Panel

Brainlab equipment (delivery Brainlab, mounting onsite)

Equipment

BNf.1 Operating Room 42" Display Mounting Frame

Existing equipment:

Equipment

E.1 Operating Room OR Table

E.2A/2B Operating Room CSU (Ceiling Supply Unit) A=ANES./B=SURG.

E.3 Operating Room 4-arm system with lights

E.4 Operating Room Laminar Air Flow

E.5 Operating Room Microscope

On-site preparation:

Electrical Preparation

P.1 Technical Room Computer Rack or Appropriate Cabinet

P.2 Operating Room Access hatch installation and maintenance

Recommended Locations


Setup (without Additional Displays): Side View

①

②

Figure 25

PLANNING


Diagram Text


No. Description

① Operating room

② False ceiling

Color Description







Existing equipment:

Equipment


E.3 Operating Room 4-Arm System



Setup (with additional Displays): Top View

① ②③

Figure 26

PLANNING


Diagram Text


No. Description

①/②Equipment room/technical room (adjacent to operating room)(Alternative location can be considered outside patient environment. To be discussedat planning stage)

③ Operating room

Color Description








BN.1a Operating Room Additional 42" Display In-Wall


BN.3a/b Operating Room CM Dual Displays







Equipment


BNf.1a Operating Room Additional 42" Display Mounting Frame

Existing equipment:

Equipment


E.2a/2b Operating Room CSU (Ceiling Supply Unit) A=ANES./B=SURG.

E.3 Operating Room 4-Arm System with OR Lights






P.2 Operating Room Access Hatch (Installation and Maintenance)



Setup (with additional Displays): Side View

①

②

③

①

Figure 27

PLANNING


Diagram Text


No. Description

① Operating room

② False ceiling

Color Description






BN.3a/b Operating Room CM Dual Display

Existing equipment:

Equipment


E.3 Operating Room 4-Arm System

Related Links

CM Camera on page 26



4.2 System Specifications4.2.1 Mechanical Specifications

Customer Responsibility

All indicated specifications are requirements to be fulfilled by the customer during planning,storage, installation and operation. It is the customer's responsibility to carry out structural/staticload analysis and certify the design and construction of the substructure.The customer is responsible for a safe mounting of the mounting plates to the wall in case of BuzzOn-Wall, respectively for a safe mounting of the mounting frame into the wall in case of Buzz In-Wall. This includes the definition of the components used to mount the device. These componentsincluding material and material quality must be adequate for the structure/substructure of the walland the weight and dimensions of the respective device.

Installation Considerations

The touch display assembly of Buzz can be flipped around its lower edge in order to service allcomponents. The chosen mounting location must provide sufficient clearance in front of and belowthe Buzz touch display. The ventilation openings of the Buzz components must not be covered.If Buzz is mounted flush (In-Wall system), sufficient heat dissipation must be ensured by eitherstructural measures or an active ventilation system. The ambient temperature shall not exceed thedefined limits during normal operation.

Wall-Mounted Devices

Use stainless steel or galvanized screws/bolts to mount the wall mounted components.Depending on the wall medium, the customer must use fasteners sufficient for the overall load ofthe system components under consideration of local codes (safety factors, etc.).

PLANNING


4.2.2 Physical Specifications

Size and Weight

Component Width Height Depth Weight includingSafe Working Load

MCU 439 mm 164.5 mm 414 mm 17 kg

42" Display On-Wall 1189 mm 667 mm 103 mm 38 kg

42" Display In-Wall 1189 mm 667 mm

103 mm(Depth inwall =98 mm)

38 kg

Additional 42" Display On-Wall 1054 mm 667 mm 103 mm 30 kg

Additional 42" Display In-Wall 1054 mm 667 mm

103 mm(Depth inwall =98 mm)

30 kg

CM Display 672 mm 411 mm 73 mm 9.5 kg

Additional CM Display 672 mm 411 mm 73 mm 9.5 kg

CM Camera 116 mm 86 mm 613 mm 1.7 kg

Manual Camera Joint 95 mm 450 mm 192 mm 2.1 kg

Connection Unit 381 mm 91 mm 377 mm 3.8 kg

Supply Unit(mounted to wall display)

169 mm 57 mm 300 mm 1.3 kg

Physical Specifications


4.2.3 Electrical Specifications

Power Use

Component Operating Volt-age

Current Frequency Power Con-sumption

MCU 100 - 240 V 8 - 4 A 50 /60 Hz Max. 850 W (typi-cally 350 W)

Converter (3,MCU Side) 100 - 240 V 0.16 – 0.08 A 50 /60 Hz Max. 19 W

Touch DisplayOn-Wall 100 - 240 V 3.5 - 1.5 A 50 /60 Hz Max. 350 W (typi-

cally 200 W)

Touch Display In-Wall 100 - 240 V 3.5 - 1.5 A 50 /60 Hz Max. 350 W (typi-

cally 200 W)

Additional TouchDisplay On-Wall 100 - 240 V 3.5 - 1.5 A 50 /60 Hz Max. 350 W (typi-

cally 200 W)

Additional TouchDisplay In-Wall 100 - 240 V 3.5 - 1.5 A 50 /60 Hz Max. 350 W (typi-

cally 200 W)

Connection Unit 100 - 240 V 1.6 - 0.8 A 50 /60 Hz Max. 190 W

Supply Unit 100 - 240 V 1.5 - 0.8 A 50 /60 Hz Max. 190 W

Fuse Ratings

Component Fuse Ratings

MCU 2 x T 10A H 250V/5 x 20 mm

Connection Unit 2 x T 1.6A H 250V/5 x 20 mm

AC Power Supply

Verify that the AC power supply branch circuit that provides power to Buzz Navigation (Ceiling-Mounted) is not overloaded. This will reduce the risk of personal injury, fire, or damage to theequipment.Buzz Navigation (Ceiling-Mounted) load should not exceed 80% of the branch circuit rating.Consult the electrical authority responsible for your facility wiring and installation requirements.

PLANNING


4.2.4 Environmental Conditions

Local Restrictions

• Store and operate the system in locations that are protected against moisture, wind, sunlight,dust, salinity and sulfur.

• Do not store system in the close vicinity of chemical products or gas.• Do not expose system to direct UV light.• Exposing the device to environmental stress above or below the specified boundaries (e.g.,

fumigation for pest control) may lead to damage or reduced lifetime of the device.

Altitude Considerations

• Unless stated otherwise, the system is rated for use at an altitude less than 3000 meters.• Transport or store the system at an altitude less than 6000 meters.

Adaption Time

Adaption time for use after extreme storage conditions is a minimum of 24 hours.

Temperature, Humidity and Pressure Conditions

Specification Operating Conditions Transport/Storage Conditions

Ambient Temperature

For components inside the op-erating room:10°C to 30°C [50°F to 86°F]For components outside theoperating room:10°C to 35°C [50°F to 95°F]

-10°C to 45°C [14°F to 113°F]

Relative Humidity 30% to 75% (non-condensing) 10% to 90% (non-condensing)

Pressure 700 to 1060 hPa 500 to 1060 hPa

Environmental Conditions


4.2.5 Hospital Network

Network Requirements

The hospital network must comply with the following definition according IEEE 802.3:1000BASE-Tor 100BASE-TX.The following requirements apply to LAN wiring:• Category 5 or better for 10/100 Ethernet• Category 5e or better for Gigabit Ethernet

NOTE: The customer must take ISO / IEC 11801 requirements into account.

WarningConnecting the device to a hospital network is creating a ME system according to IEC60601-1. Brainlab recommends that the hospital network components are compliant withan adequate IEC standard.

Network Bandwidth and Latency

Bandwidth Minimum: 5 Mbit/s

Latency Minimum: ≤ 50 ms

Network Precautions

Connecting the Buzz Navigation (Ceiling-Mounted) to a hospital network that includes otherequipment might result in previously unidentified risks to patients, operators or third parties.The hospital should identify, analyze, evaluate and control risks arising by connecting the BuzzNavigation (Ceiling-Mounted) to a hospital network.Subsequent changes to the hospital network may introduce new risks and require additionalanalysis. Changes to the hospital network include:• Changes to the hospital network configuration• Connecting additional items to the hospital network• Disconnecting items from the hospital network• Updating or upgrading equipment connected to the hospital network

It is recommended to use an adequate separation device for the network (LAN) interface with arating of minimum 1 MOOP and a dielectric strength of minimum 1.5 kV.

Only operate the equipment in secured networking environments. Make sure the network isprotected against unauthorized access (e.g., user authentication, firewall, etc.) and againstmalicious software. If connected to an insecure network, the equipment functionalitycannot be guaranteed (e.g., due to possible malicious/non-secure software infections).

When integrating the Buzz Navigation (Ceiling-Mounted) into a wireless network, select anadequate encryption (e.g., WPA2) to protect patient data from unauthorized access.

PLANNING


4.3 Mounting Options

General Information

In general, installing ceiling-mounted devices requires a superstructure and/or substructure towhich the arm supplier will attach their mounting system according to their specifications. Thecustomer or builder is responsible for providing and certifying the fixed attachment between thearm supplier's mounting systems and building superstructure or substructure by a certifiedstructural engineer of record.The building superstructure and/or substructure must be capable of supporting the weight andload of the camera and display together with the weight and load of the used arm system.Refer to the arm supplier documentation for details.Ultimately, it is the responsibility of the project’s structural engineer to specify and approve theattachment methods and if necessary, carry out a structural load analysis and certify the designand construction of the superstructure or the substructure.

On-Site Logistics

In order to guarantee best practice and a short implementation period, certain requirements mustbe fulfilled by the customer (or customer-assigned third-party vendors) prior to the Brainlabinstallation. The following section gives a brief overview of the typical scope of work.

Wall/Substructure

Structural/static approval by licensed engineer.

Definition of Protective Earth, Functional Earth and Potential Equalization

PROTECTIVE EARTH (PE): Conductor to be connected between the PROTECTIVEEARTH TERMINAL and an external protective earthing system (e.g., electrical safety).

FUNCTIONAL EARTH (FE): Terminal, directly connected to a circuit or to a screeningpart, that is intended to be earthed for functional purposes (e.g., EMC, SHLD).

POTENTIAL EQUALIZATION: Conductor other than a PROTECTIVE EARTH CON-DUCTOR or a neutral conductor, providing a direct connection between electrical equip-ment and the potential equalization busbar of the electrical installation (e.g., compensa-tion of voltage, single fault condition (SFC)).

Duct Work/Conduits

• Conduit implementation according to the Brainlab drawings• Inner diameter: 40 mm (1.57") (unless stated otherwise: refer to Brainlab drawings)• All conduits to be prepared with pull wire• Refer to schematics for routing overviews

Suggested Mounting Height

The recommended center mounting height for the Buzz Touch Display In-Wall/On-Wall is at150 cm (59") above finished floor.

Mounting Options


4.3.1 42" Display On-Wall Mounting

General Information

The on-wall 42" Display metal frame is provided prior to the main shipment. Prepare and set upmounting plates according to Brainlab drawings.The On-Wall mounting plate kit consists of one component:• (A) Main Display Mounting Frame

NOTE: As well as these dimensions, you must include 10 cm clearance around the display.

How to Install Buzz On-Wall

Step

1. Mount the Main Display Housing Frame (A) to the wall with one single screw using thehole ① on the upper back side. This screw is only required for easy leveling of the hous-ing and must be removed later. The suggested mounting height is 177 cm (69.7") fromfinished floor to the hole ①.

2. Level and fasten the Main Display Housing Frame (A) using the four long slots ②.

3. Remove screw ① from the hole.

4. Create a silicone joint on the top side between the wall and the Main Display HousingFrame to reach an ingress protection of class IP21. Otherwise, only IP20 can be ach-ieved.

5. Clip the foam cover from the packaging into the Main Display Housing Frame (A) as aprotection against scratches. See detailed description in the attached packaging leaflet.

PLANNING


4.3.2 42" Display In-Wall

General Information

The Display Housing (In-Wall) metal frame is provided prior to the main shipment.To achieve the recommended mounting height, center cutout at 150 cm (59") above finished floor.If a different mounting height is desired, adjust accordingly.The cutout for the frame must be 1140-1144 mm x 619-625 mm to enable the installation of theframe.The minimum depth of the opening is 98 mm (5.5").Sufficient ventilation must be ensured. Do not obstruct the vents on top and bottom of the frame.The in-wall mounting plate kit consists of the Display Housing (In-Wall) metal frame.NOTE: If several 42" Displays in-wall are mounted adjacent to each other, plan a 6-10 cm (2-4")gap between the in-wall frames to avoid interference of the protruding front bezels.

How to Install the 42" Display Housing (In-Wall)

Step

1. Slide the Display Housing (In-Wall) into the wall cut out.

2. Level and fasten the Display Housing (In-Wall) using the 16 long slots at the sides of thehousing.

3. Create a silicone joint between the yellow design frame and wall surface to reach an in-gress protection of IP44.Otherwise, only IP20 can be achieved.

4. Clip the foam cover from the packaging into the Display Housing (In-Wall) as a protec-tion against scratches. See detailed description in the attached packaging leaflet.

42" Display In-Wall


4.3.3 Additional 42" Display On-Wall

General Information

The additional 42" Display On-Wall metal frame is provided prior to the main shipment.Prepare and set up mounting plates according to Brainlab drawings.The On-Wall mounting plate kit consists of one component:• (A) Display mounting frame

NOTE: As well as these dimensions, you must include 10 cm clearance around the display.

PLANNING


4.3.4 Additional 42" Display In-Wall

General Information

The additional Display Housing (In-Wall) metal frame is provided prior to the main shipment.• To achieve the recommended mounting height, center cutout at 150 cm (59") above finished

floor. If a different mounting height is desired, adjust accordingly.• The cutout for the frame must be 1005-1009 mm x 619-623 mm to enable the installation of the

frame.• The minimum depth of the opening is 98 mm (3.9").• Sufficient ventilation must be ensured. Do not obstruct the vents on top and bottom of the

frame.Prepare and set up mounting plates according to Brainlab drawings. The In-Wall mounting platekit consists of one component:• (A) Display Housing (In-Wall)

NOTE: If more 42" Displays In-Wall are mounted adjacent to each other, plan a 6-10 cm (2-4")gap between the In-Wall frames to avoid interference of the protruding front bezels.

How to Install Display Housing (In-Wall)

Step

1. Put the Display Housing (In-Wall) (A) into the wall.

2. Level and fasten the Display Housing (In-Wall) (A) using the 16 long slots ① at eachside in the display metal frame.

3. Create a silicone joint between the yellow design frame and wall (Ingress ProtectionIP44).

4. Clip the foam packaging cover as protection against scratches in the Display Housing(In-Wall) (A).

Additional 42" Display In-Wall


4.3.5 Ceiling Superstructure and Substructure

General Information

In general, installing ceiling-mounted devices requires a superstructure and/or substructure towhich the arm supplier will attach their mounting system according to their specifications. Thecustomer or builder is responsible for providing and certifying the fixed attachment between thearm suppliers mounting systems and building superstructure or substructure by a certifiedstructural engineer of record.The building superstructure and/or substructure must be capable of supporting the weight andload of the camera and display together with the weight and load of the used arm system. Refer tothe arm supplier documentation for details.Ultimately, it is the responsibility of the project’s structural engineer to specify and approve theattachment methods and if necessary, carry out a structural load analysis and certify the designand construction of the superstructure or the substructure.

Scope of Responsibility

Figure 28

Pre-Engineered Mounting Systems

Third-party arm suppliers typically offer pre-engineered mounting systems for equipmentmounting, which can be purchased together with the arm systems.For details on supplier-specific pre-engineered mounting systems, refer to the third-party armsupplier documentation.Depending on the specific site, a pre-engineered mounting system may be attached as follows:• Welded to superstructure or fabricated substructure• Bolted to superstructure or fabricated substructure• Anchored to structural concrete slab or structural composite deck (common in the US and

Japan)

Load Overview

The actual loads and moments of the entire setup depends on the project-specific armconfiguration and specified third-party arm supplier and therefore must be calculated for thespecific project.The actual load and moments for each installation depend on a number of factors and can, incase of uncertainty, only be accurately determined by a qualified structural engineer of record,using site-specific structural calculations.

PLANNING


Brainlab is not responsible for observing site-specific structural safety measures.

Safety Factors

The weight values of the ceiling-mounted components do not include a safety factor, but are realmeasured values. The following are the responsibility of the customer:• Calculate the total load for each device, including any necessary substructures, and include it

in any further calculations.• Calculate a minimum safety factor for the ceiling superstructure. In accordance with DIN EN

60601-1, a safety factor of 4.0 is required.• Guarantee compliance of the calculated factor with the local statutory requirements (regulatory

guidelines and applicable codes)Brainlab recommends a safety factor of at least 4.0 (in accordance with DIN EN 60601-1, only innon-earthquake zones). The vertical loads and bending moments specified for all ceiling-mountedcomponents should therefore be multiplied by at least 4.0. It is the responsibility of the customerto evaluate an appropriate safety factor in an earthquake zone.

Related Links

System Specifications on page 71

Ceiling Superstructure and Substructure


4.3.6 Connection Unit

Mounting Considerations

• Preparation and provision of shelf space for the Connection Unit: If the Connection Unit isplaced on a CSU, the CSU must be capable of supporting the weight of the Connection Unit.

• The Connection Unit cannot be stacked.• The Connection Unit can be positioned within the patient environment.• The Connection Unit cannot be positioned in a different orientation than described here.• If the fiber optic cables of the Connection Unit are not routed in-wall or through a CSU, cable

protection is recommended (on-wall/floor conduits).• Potential positioning risk: damaging of fiber optic cables at the back of the Connection Unit if

exposed to mechanical force.• The Connection Unit housing should not be covered to avoid over-heating.

Secure the Connection Unit against tipping over.

Connection Unit Position

The preferred position for Connection Unit is horizontal. It can be placed in a vertical positionunder the following restrictions:• This is not allowed in MR environments.• It must be secured against tipping over.• The Brainlab logo must point downwards.

PLANNING


4.3.7 Supply Unit

General Information

In general, a Supply Unit is installed for each CM Display. This section only applies for the SupplyUnit of the additional CM Display, since the Supply Unit of the standard CM Display is attached tothe 42" Main Display frame.

Preparation

If an additional CM Display is installed, the second Supply Unit can be placed with the followingoptions:• in the wall behind the 42” Main Display• on the ceiling.

For the first option, a cutout in the wall behind the 42” Main Display must be prepared, which mustprovide enough space to enable the installation and a sufficient ventilation of Supply Unit.The following image shows an example of the cutout (marked with broken line) and the location ofsecond Supply Unit behind the 42” Main Display.

①

②

③

Figure 29

No. Description

① Supply Unit

② Behind (in wall)

③ Supply Unit 2nd CM Display

Supply Unit


4.3.8 Medical Computer Unit

Ventilation Openings

Do not restrict the ventilation openings of the MCU.

① ②

Figure 30

No. Component

① Exhaust areas (back side)

② Air intake areas (underside)


• Preparation and provision of shelf or rack space for the MCU: The shelf or rack on which theMCU shall be positioned must be capable of supporting the weight of the MCU and meet spacerequirements.

• The MCU shall not be installed in the patient environment.• The MCU cannot be stacked.• The MCU is an actively cooled device. Consider the location and direction of the vents when

positioning the MCU.• If the MCU is placed in a 19" rack, four (4) height units must be available.• The MCU is not designed for wall-mounting.• If the fiber optic cables of the MCU cannot be routed in-wall, cable protection measures are

recommended (on-wall/-floor conduits).• Potential positioning risks:

- Accidental contact with mains power switch at the front turns the system off (in particular tobe considered when placing under table).

- Damage to fiber optic cables at the back of the MCU if exposed to mechanical force.

PLANNING


4.3.9 Converter Box


• Preparation and provision of shelf or rack space for the Converter Box: The shelf or rack onwhich the Converter Box shall be positioned must be capable of supporting the weight of theConverter Box and meet space requirements.

• The Converter Box shall not be installed in the patient environment.• The Converter Box can be stacked on the Medical Computer Unit.• If the Converter Box is placed in a 19" rack, two (2) height units must be available.• Horizontal positioning is recommended.

Converter Box


4.3.10 Rack Installation

General Information

Buzz Navigation (Ceiling-Mounted) does not include a rack. To install Buzz Navigation(Ceiling-Mounted) on a rack, the rack must have at least 7 Height Units (HU).Extra shelves are required for the MCU and Converter Box. The Patch Field can be mounteddirectly in a 19" framework without shelves.The rack must also provide 4 power outlets for the MCU and 3 converters.

Height Units

Component Height Units

MCU 4 HU

Converter Box 2 HU

Patch Field 1 HU

PLANNING


4.4 Electrical Outlets

Electrical Considerations

• Mains power connections and outlets as per Brainlab planning drawings.• The appliance coupler must be readily accessible or a main switch or Indicator installation

according to Brainlab specifications is required.

Safety Considerations

WarningTo avoid the risk of electric shock, Buzz Navigation (Ceiling-Mounted) (Class 1) equipmentshall only be connected to mains power equipped with Protective Earth in accordance withIEC 60601-1:2012 Clause 7.9.2.2.

Power Supply

Mains power outlets (one each) in direct proximity are required for:• MCU• Connection Unit• 42" Display• Optional additional 42" Display• Supply Unit(s)

In addition, three mains power outlets are required for the converters which cannot be connectedto the MCU.The mains power must meet the following criteria:• 100-120 V/200-240 V ± 10%• 50/60Hz

NOTE: For the North American market the voltage is restricted to 100-120Vac, 60 Hz.

Buzz Navigation (Ceiling-Mounted) does not provide an uninterruptible power supply.Brainlab recommends providing Buzz Navigation (Ceiling-Mounted) with a battery backupsupply mains.

Requirements for External Main Switch or Indicator

Scenarios:

Component Setup Mains Plug accessi-ble and visible foroperator

External MainsSwitch or Indicatorrequired?

MCURack installation Yes No

Flat surface (e.g., ta-ble) Yes No

42" Display and/or ad-ditional 42" Display

On-Wall Yes No

In-Wall No Yes

Connection UnitFlat Surface (e.g., ta-ble, CSU) Yes No

Integrated No Yes

Electrical Outlets


Component Setup Mains Plug accessi-ble and visible foroperator

External MainsSwitch or Indicatorrequired?

CM Display / Addition-al CM Display / CMCamera with SupplyUnit

CM Arm System No Yes

Requirements for External Main Switch

A main switch must be provided in close vicinity to the Buzz Navigation (Ceiling-Mounted)component that meets the following requirements:• Must be conform to IEC 61058-1 for a mains transient voltage of 4 kV• Must disconnect phase and neutral simultaneously• Protective earth may not be separated by the switch• Must be recognizable that the switch belongs to the Buzz Navigation (Ceiling-Mounted)

component(s)• The switch must be labeled according to IEC 60601-1:2012 Clause 7.4.1• Must be suitable for the electrical specifications of component(s) connected to the switch.

NOTE: The components can also switched in series (e.g., Touch Display and Additional Display),if the Mains Switch is suitable for the Power Requirements.

PLANNING


4.4.1 Configuration

Wiring Concept

①②③⑤

④

Figure 31

Configuration


No. Text in Illustration

①

Fiber optic signal cableCamera Ethernet cablePE cable cameraCopper cable display powerFiber optic signal cableCable bundle

② OR

③ Ceiling

④ Supply unit

⑤ Server room

NOTE: The MCU is in the server room.

NOTE: If using an additional CM Display, the Supply Unit for it is mounted in the ceiling or in anopening behind the 42’’ Display frame.

PLANNING


4.5 MCU Rack Installation

Requirements

To install the MCU in a computer rack, the MCU must be placed in a computer rack with aminimum width of 600 mm.• The height of mounting angles must not exceed 30 mm to ensure sufficient ventilation of the

MCU.

• The heat distribution of the MCU is 400 W.• The temperature inside the rack should not exceed +35°C.• The environmental requirements must be fulfilled.• The minimum required height inside the rack for the computer is four rack units: 177.8 mm

(4 x 44.45 mm).

MCU Rack Installation


4.6 Required Service Access to 42" Display

General Information

The 42" Display can be flipped down 90° when Brainlab services the system. Ensure that there issufficient space in front of and below the system and no permanent objects are installed there.

Required Access Area

Figure 32

PLANNING


4.7 Ventilation

Ensuring Ventilation

Do not cover or block ventilation openings. Otherwise the system could overheat and be seriouslydamaged.

Ventilation Openings on 42" Display On-Wall

Ventilation openings are located on the bottom and sides of the system as marked below.

Figure 33

In-Wall Ventilation Openings

Ventilation openings are located as marked below.

① ②

Figure 34

No. Component

① MCU connection panel

② MCU user panel

NOTE: There are no exposed ventilation openings on the In-Wall 42" Display.

NOTE: The MCU must be installed on the bottom plate.

Ventilation


Buzz In-Wall Mounting Frame

Ventilation openings are located as marked below.

Figure 35

NOTE: There are no exposed ventilation openings on the in-wall 42" Display.

PLANNING


4.8 42" Display Ventilation4.8.1 Overview

General Information

The installation must ensure that 100 W can be diverted from the inside of the wall.The air temperature inside the wall must not exceed 35°C. The installation can be with activecooling as well as passive cooling.Parameters that influence heat distribution and should be considered especially for a passivecooling are:• The wall material surrounding the air volume inside the wall (thermal conductivity, thickness of

materials).• The temperature inside the OR (heating below or above the 42" Display should be prevented).• The unobstructed air volume within the wall (which can be improved, i.e., with greater wall

depth, opening to the ceiling and/or ventilation grids).

Heat Distribution Without Openings

The below image shows the heat distribution when no openings or ventilation grids are installed:

Figure 36

42" Display Ventilation


Heat Distribution With Openings

The below image shows the improved heat distribution with ventilation grids installed below andabove the touch display:

Figure 37

PLANNING


4.9 Magnetic Resonance (MR) Environment

Safety Information

Ensure that all arm systems with Buzz Navigation (Ceiling-Mounted) components fulfill therequirements for the MR environment. The range of the arm system must conform to therequirements for the MR environment. See MR Safety below.The following components are rated “MR conditional” according to ASTM F2503-13 (StandardPractice for Marking Medical Devices and Other Items for Safety in the Magnetic ResonanceEnvironment): 42" Display(s), Feature Panel, CM Camera with manual joint, CM Display(s),Connection Unit.While planning the electric power supply network of the MR cabin, consider that all BuzzNavigation (Ceiling-Mounted) components inside the MR cabin must be separated from mainspower during every MR scan in order to avoid possible artifacts.

MR Safety

All components must be installed according to this table:

Component Located within 50 Gauss (5mT) volume

Located within 5 Gauss (0.5mT) volume

CM Camera

Not allowedAllowed

CM Display including joint

42" Display

Supply Unit

Connection Unit

Coupling Box

MCU Not allowed

The MCU is not tested in an MR environment and must not be positioned inside the MRenvironment.Consider that during MR imaging, the Connection Unit must be switched off. (For moreinformation on MR safety and MR scan mode see the System and Technical User Guide).

MR Conditional

Non-clinical testing has demonstrated the 42" Display(s), Feature Panel,Supply Unit, CM Camera with manual joint, CM Display and ConnectionUnit are MR Conditional.

A patient with this device can be safely scanned in an MR system meeting the followingconditions:• Static magnetic field of 1.5 Tesla and 3 Tesla, with maximum spatial field gradient of 2.0 G/cm

(0.02 T/m).• To prevent autonomous acceleration, do not move device across 5 mT (50 Gauss) line.• All components have to be powered off during scanning.

MR-induced malfunction testing with device exposure to the clinical level static field B0, theswitched gradient field (dB/dt) and the RF field (B1, E) in 1.5 Tesla and 3 Tesla MR systemspassed all tests according to Brainlab testing procedure.

Magnetic Resonance (MR) Environment


Safety Notes

If using the system in an MR environment, ensure that the arm system also complies with this MRenvironment.The ceiling-mounted arm system need to be compliant with applicable standards (e.g., IEC60601-1).

WarningThe Connection Unit must be placed in a horizontal position (on its bottom side). Do notplace the Connection Unit vertically in an MR environment. The component has not beentested for this and might behave differently.

WarningThe Manual Joint, CM Display, CM Camera, Connection Unit, Supply Unit, 42" Display (maindisplay and additional display), can be exposed to a field strength of maximum 50 Gauss/5mT (MR Conditional). They must be placed outside the 50 Gauss/5 mT line and switched offduring the MR scan.

PLANNING


Operating Room

① ②③

④

Figure 38



Diagram Text


No. Description

①Preparation/scrubRecommended 15-20 m2

②Control RoomRecommended 10-15 m2

③Operating room iMRIRecommended 65-85 m2

④Equipment roomRecommended 10-20 m2

Color Description



(green) Delivery and mounting by imaging device supplier





BN.1 Operating Room Main 42" Display In-Wall

BN.2 Operating Room Supply Unit





Additional Equipment

aE.1 Technical Room Converter Box (Transfer Line Converter)

aE.2 Technical Room Patch Panel

aE.3 Operating Room Coupling Box


Equipment

BNf.1 Operating Room 42" Display mounting frame

Existing equipment:

Equipment

EE.1 Operating Room OR Table

EE.2 Operating Room CSU (Ceiling Supply Unit)

EE.3 Operating Room 2-arm system

EE.4 Operating Room Laminar air flow

PLANNING




PP.1 Technical Room Computer rack or appropriate cabinet



5 REQUIREMENTS ANDSPECIFICATIONS

5.1 Requirements for Ceiling Arm Integration

Scope

The scope of this section is to provide sufficient details of the Buzz Navigation (Ceiling-Mounted) characteristics to identify the correct ceiling-mounted arm system to use in order toobtain a safe combination, namely:• General integration aspects of the Buzz Navigation (Ceiling-Mounted) in an OR• Specific aspects for assessing if a particular ceiling-mounted arm system is compatible with

Buzz Navigation (Ceiling-Mounted)In addition, it provides sufficient details to identify the correct CSU in order to obtain a safecombination and to asses if the environment is suited for the Buzz Navigation (Ceiling-Mounted).The ceiling-mounted arm system need to be compliant with applicable standards (e.g., IEC60601-1).

Cabling

The ceiling-mounted arm system needs to provide enough space for appropriate cabling asspecified below to ensure safe and effective signal transfer.The cables installed inside the arm systems must not be run over sharp edges that could causecable damage.

Display Specifications and Requirements

Part Specification

Display weight9.5 ± 0.5 kgNOTE: Consider the display mount (below).

Display mount Vesa 100 Mount. Compatible for the dimensions of the display (i.e.,672.15 x 410.5 x 72.7 mm (W/H/D))

REQUIREMENTS AND SPECIFICATIONS


Part Specification

Arm system screws (cus-tomer responsibility)

Specified so that the display-side interface of the display mount iscompatible with VESA 100.For the fixation of the display following screws must be used:• Diameter: M4 Thread Pitch 0.7

Max Torque 1.2 ± 0.1 Nm (0.89 ft lb)• Length of screw: must be defined by arm supplier. Requirement is

that the effective length within the display is 23 ± 1 mm.NOTE: As Brainlab does not know the thickness of the display hold-er and the potentially required adapter plate, Brainlab does not pro-vide the required screws. The screws shall be provided by the armsupplier. When delivering the arm system, the appropriate screwsand the potentially required adapter plate shall be affixed to the armusing nuts.

Rotation The display mount of the arm system allows a rotation of max. 335°

Cable mounting The arm system is specified to enable the mounting of the cable15700-93 with a diameter of approx. 14 mm.

Additional display specifi-cations

• The display may be installed inside the patient environment.• The display contains a touchscreen with projected-capacitive

touch (PCAP) technology.• The display contains one speaker.• The display is powered by the Supply Unit with 24 VDC.• The heat emission of the display is max. 50 W.

Inclination of display Must be limited to +60° / -30°

Ground connection termi-nal At central axis

Camera Specifications and Requirements

Part Specification

Camera (with joint) weight3.9 ± 0.5 kgNOTE: CM Camera consists of Tracking Unit (2.1 kg) and ManualJoint (1.8 kg).

Manual joint interface Defined in its dimensions that it fits to an Ondal AC2000, Valia Sand MD21/MD21+ without any adapters.

Rotation

The interface of the spring-loaded arm has a rotation stop limiting,which is compatible with the interface of the manual joint. The aim isto prevent damaged cables due to unlimited rotation. The overall ro-tation depends on the size of the limit stop, (i.e., installation on anOndal AC2000 allows for a 330° rotation).

Cable mountingThe arm system is specified to enable the mounting of the cablebundle 15895 with a diameter of approx. 15 mm and a diameter ofapprox. 16 mm for the Ethernet plug of the cable.

Additional camera withmanual joint specifications

• The camera with manual joint may be installed inside the patientenvironment.

• The camera is powered by the supply unit with 42.5 -57 VDC(PoE+ IEEE 802.3at).

• The heat emission of the camera is max. 30W.

Requirements for Ceiling Arm Integration


Part Specification

Range of motion of cam-era with manual joint

Yaw axis:

The adjustment depends on the size of the limit stop at the interfaceof the spring loaded arm, (i.e., installation on an Ondal AC2000 al-lows for a 330° rotation).Pitch axis:

The IR Tracking Unit can be adjusted in a range of minimum 0° and90° downwards relative to the horizontal plane.Roll axis:

The IR tracking unit can be adjusted manually in a range of mini-mum 45° around the roll axis from the horizontal position (min. 45°clockwise, min. 45° anti-clockwise rotation).

General Arm-Related Requirements

Part Specification

Protective EarthThe display/camera requires an adequate Protective Earth terminal(close to the central axis) that is connected to the hospital ProtectiveEarth.

RotationEach arm has rotation stops limiting the horizontal rotation to max.:• 315° between spring arm and extension arm• 335° between extension arm and central axis

Up-down movement The up/down movement of the ceiling arm system is restricted to amaximum angle of 100° (+40° to -60°).

CablesCables inside the arm system have a min. bending radius of 10 mm.The arm system is specified so that cables installed inside the armsystems will not be damaged, (e.g., by sharp edges).

Ground connection ter-minal At Central Axis

Related Links

System Specifications on page 71Cabling Specifications for In-Arm Cables on page 45



5.1.1 Ceiling Supply Unit (CSU)

Connection Unit Specifications and Requirement

The Connection Unit is intended to be installed on a CSU inside the OR. The followingspecifications and requirements can be used to assess if a particular CSU is compatible to theBuzz Navigation (Ceiling-Mounted). The customer must ensure that the CSU fulfills allspecifications and requirements.NOTE: For the North American market the voltage is restricted to 100-120VAC, 60Hz.

WarningDo not restrict the ventilation openings of the CSU.

Diagram - CSU with Connection Unit

①

②

⑥

③

⑤

④

⑦Figure 39

Ceiling Supply Unit (CSU)


Diagram Text


No. Description

① Ceiling Supply Unit (CSU)

② Access for installation and maintenance

③Connection UnitKeep free space of 100 mm at rear side, to connect external imaging source

④1 x Power supply1 x Potential equalization1-2 Iotek cable glands (delivered by Brainlab)

⑤ Front view

⑥ Side view

⑦ Operating room



5.1.2 Medical Computer Unit (MCU)

Computer Unit Requirements and Specifications

The location where the MCU is installed must:• Be specified to carry the weight of the MCU (17 ± 1 kg).• Be specified for the size of the MCU (439 x 164.5 x 414 mm (W/H/D)).• Be compatible with power consumption and a waste heat of MCU of maximum 850 W.• Provide a power socket for the MCU (100-240V and 50/60Hz).

NOTE: For the North American market the voltage is restricted to 100-120VAC, 60Hz.

• The noise emission of the MCU does not exceed 45 dB(A), when it is positioned in normaloperating position on the floor, measured at a distance of 1 m and height of 1.2 m.

• The MCU ventilation openings shall not be blocked.• The MCU must:

- Be installed outside the OR.- Be installed outside of the MR environment.- Not be installed in the patient environment.

The MCU has an internal power supply.

Related Links

System Specifications on page 71

Medical Computer Unit (MCU)


6 SITE PREPARATION6.1 Installation Requirements6.1.1 On-Site Logistics

General Information

In order to guarantee best practice and a short implementation period, certain requirements mustbe fulfilled by the customer (or customer-assigned third-party vendors) prior to the Brainlabinstallation. The following section gives an overview of the typical scope of work.

Cable Strain Relief

Figure 40

To prevent possible injury to the patient or OR personnel, cables connecting floor components tothe Connection Unit (like a microscope) must be tethered to the mounting location of theConnection Unit. Use the Velcro strap on the microscope cable in connection with either a bar onthe CSU or an alternative means (like a hook) in close proximity of the connectors.NOTE: Refer to Brainlab drawings for site-specific preparation, size and routing of conduit forSELV power and fiber.

SITE PREPARATION


Ceiling Access

Ceiling access in the form of a hatch or removable lighting fixture must be provided for installationof cables in a conduit.Circular apertures in the ceiling concentrically located on the axis of the CSU and the arm systemsare needed for installation and maintenance of Brainlab components.

Electrical Power

Mains power connections and outlets, as per Brainlab project-specific drawings, must be active forBrainlab component installation and testing.

Networking

Network access points (LAN drops), as indicated on Brainlab project-specific drawings, must beactive with hospital IP addresses issued for Brainlab component configuration and testing.

Temporary Supplies/Services

In order to install Brainlab components, the environment must be well lit, dust free, and climatecontrolled.In addition, the following equipment may be needed:• Pallet jack• Step ladders• Waste containers• Elevator• Fork lift

Installation Requirements


6.1.2 Duct Work/Conduits

General Information

Refer to the drawings below for site-specific preparation, size and routing of conduit for SELVpower and fiber optic transfer lines.The customer is required to provide conduits as outlined in this section.Unless noted otherwise, the minimum inner diameter for all conduits is 40 mm [1.57''] with aminimum bending radius of 300 mm [11.8"]. Preparations must be carried out in accordance withthe Brainlab project-specific layouts and drawings. Ensure that a pull wire is supplied in everyconduit.NOTE: If a 300 mm [11.8"] bending radius is not feasible, contact Brainlab consulting. Brainlabrecommends conduits with a smooth internal finish.

Minimum Required Conduits

The cabling for Buzz Navigation (Ceiling-Mounted) requires at least the number of conduits forthe stated connection in the table below. Each conduit must be at least 40 mm diameter.

Amount Ø Conduit from Conduit to Cabling/Options

1 40 mm MCU/Patch field Main Touch Dis-play (Supply Unit)

Custom10 m20 m30 m50 m70 m100 m

1 40 mm MCU/Patch field Coupling Box(Connection Unit)

Custom10 m20 m30 m50 m70 m100 m

1 40 mm Supply UnitArm SystemCM Display

11 m

Option

1 40 mm MCU/Patch field Additional 42"Touch Display

Custom10 m20 m30 m50 m70 m100 m

1 40 mm Touch Display Additional 42"Touch Display 25 m

Additional conduits may be needed for optional external components, (e.g., additional display).

SITE PREPARATION


Buzz Navigation (Ceiling-Mounted) Installation with OR Lights

Additional conduits, power, grounding, wall cutouts, or other on-site preparations may benecessary, depending on the specific OR light. Refer to the specific OR light supplier's projectinstructions.

Cable Trays

Cable trays may be used in place of conduits only when complete access along the entire lengthcan be guaranteed by the customer. This is valid for both during installation and any futuremaintenance.Conduits along the length of the cable trays are required to protect the fiber optic cables.

Duct Work/Conduits


Site Preparation (without Additional Displays)

①

②

Figure 41

SITE PREPARATION


Diagram Text


No. Description

①Equipment room/technical room (adjacent to operating room)(Alternative location can be considered outside patient environment. To be discussedat planning stage)

② Operating room

Color Description





Electrical on-sitepreparation

FloorPlanSymbol

Description

Standard power outlet according to local norms. Recom-mended: generator and UPS backup

Power outlet - switchable (e.g., via room control or powerswitch)

RJ45 network socket (hospital network)

Power switch with light indicator, connected to power out-let, all pole breaking; on wall and visible

Grommeted cover plate with cable feed through

Potential equalization (optional)

Floorplan

Eleva-tion

Conduits with pull wire. Inner diameter 40 mm / 1.57inch. Total cable length refers to distance from and toeach device plug and does not mean conduit length







Duct Work/Conduits





BN.7 Technical Room Convertor Box


Brainlab equipment (delivery Brainlab, mounting by others)

Equipment


Existing equipment:

Equipment


E.2A/2B Operating Room CSU (Ceiling Supply Unit) A=ANES./B=SURG.

E.3 Operating Room 4-arm system with OR lights






P.2 Operating Room Access hatch (installation and maintenance)

Conduits requirements to be installed/ready prior Brainlab's installation:

Name Quantity Length (m) Start End

BL.A 1 max. 100* + 8 MCU BN.6 Connection UnitBN.4

BL.B 1 max. 100* MCU BN.6 42" Display BN.1

BL.C 1 20 42" Display BN.1 CM Camera BN.2

BL.D 1 11 + 8 42" Display BN.1 CM Display BN.3

* length depending on Long Distance Cabling options

SITE PREPARATION


Site Preparation (with Additional Displays)

①②

Figure 42

Duct Work/Conduits


Diagram Text


No. Description

①Equipment room/technical room (adjacent to operating room)(Alternative location can be considered outside patient environment. To be discussedat planning stage)

② Operating room

Color Description


(orange) Delivery by brainlab; mounting by builder/customer



Electrical onsitepreparation

FloorPlanSymbol

Description

Standard power outlet according to local norms. Recom-mended: generator and UPS backup

Power outlet - switchable (e.g., via room control or powerswitch)

RJ45 network socket (hospital network)

Power switch with light indicator, connected to power out-let, all pole breaking; on wall and visible

Grommeted cover plate with cable feed through

Potential equalization (optional)

Floorplan

Eleva-tion

Conduits with pull wire. Inner diameter 40 mm / 1.57inch. Total cable length refers to distance from and toeach device plug and does not mean conduit length




BN.1a Operating Room Additional 42" Display In-Wall


BN.3a/b Operating Room CM Dual Displays

SITE PREPARATION









Equipment


BNf.1a Operating Room Additional 42" Display Mounting Frame

Existing equipment:

Equipment


E.2 Operating Room CSU (Ceiling Supply Unit)

E.3 Operating Room 4-arm system with OR Lights






P.2 Operating Room Access hatch (installation and maintenance)

Conduits requirements to be installed/ready prior Brainlab's installation:

Name Quantity Length (m) Start End

BL.A 1 max. 100* + 8 MCU BN.6 Connection UnitBN.4

BL.B 1 max. 100* MCU BN.6 42" Display BN.1

BL.C 1 20 42" Display BN.1 CM Camera BN.2

BL.D 1 11 + 8 42" Display BN.1 CM Display BN.3a

BL.E 1 max. 100* MCU BN.6 42" AdditionalDisplay BN.1a

BL.F 1 max. 20** 42" Display BN.1 42" AdditionalDisplay BN.1a

BL.G 1 100 42" Display BN.1 CM Display BN.3b

* length depending on Long Distance Cabling options** length depending on Relay Control Line

Duct Work/Conduits


6.1.3 Protective Earth Connections/Potential Equalization

Protective Earth

It is the customer’s responsibility to provide a means for connecting the Brainlab-providedProtective Earth cables of the CM Display and CM Camera close to the ceiling flange of the armsystem prior to system installation. The customer must choose a terminal connection cross-section that meets the national and local standards for protection.Details of the connection point to be provided by the customer:Threaded post terminal, diameter up to 5.3 mm.NOTE: The provision of a Protective Earth cable by the customer does not comply with Brainlabrequirements.

A separate protective earth cable is a safety measure and required for the Buzz Navigation(Ceiling-Mounted) monitor(s) only. Both the Buzz Navigation (Ceiling-Mounted) MCU and theConnection Unit are covered by the protective earth wire of their power cords.

Potential Equalization

As well as the Protective Earth connection, Brainlab provides the option to connect a PotentialEqualization cable to the satellite devices (Buzz Navigation (Ceiling-Mounted) Connection Unitand MCU). The use of the Potential Equalization points on the Buzz Navigation (Ceiling-Mounted) MCU and the Connection Unit is not mandatory and at the discretion of the hospital. Ifthe hospital requires the use of the Potential Equalization, the Potential Equalization connectionpoint on the hospital’s side must be provided by the customer close to the Brainlab components tobe connected (cables are provided by Brainlab).The use of the Potential Equalization connections is not safety relevant and is used only tomitigate against interferences between multiple devices on different circuits.

SITE PREPARATION


Protective Earth Connections/Potential Equalization


7 IMPLEMENTATION7.1 General Time Line/Durations7.1.1 Overview

General Information

Consulting / Requirement

analysis / Pre-Planning Phase

Planning Phase On-Site visit Detailed PlanningPreparation / Pre-

Installation / Production

Installation Training

Purchase Agreement

Training Acceptance / Release for clinical use

Minimum 3 weeks*(varies)

1 – 2 daysMinimum 2 weeks*

Approximately 10-12 weeks

Approximately 1 week

Design Freeze

„sign off“

System Installation Acceptance

Miltestone

*NOTE: The entire planning phase as well as the whole project duratation ultimately depends on the information and communitcation flow among the involved project parties.

Minimum of 16 weeks*

Phase

Approximately 1 week

Figure 43

The actual timeline for each project varies depending on the installation. This timeline should onlybe used as a rough guide. The actual timeline can only be confirmed after the Brainlab layoutdrawings have been approved and signed by the customer. This normally occurs during thedetailed planning phase/design freeze.It is recommended that the customer nominates an appropriate, dedicated project manager ortechnical representative for planning and installation who will communicate customer-specificrequirements to the Brainlab customer consultant. Experience has shown that a well-coordinatedhospital project team greatly contributes to keeping the project timeline on schedule.

IMPLEMENTATION


7.2 Project Phases

Consulting and Requirement Analysis

This is the preliminary feasibility phase. It involves the technical feasibility analysis to verify thelocation and technical suitability of system implementation of Buzz Navigation (Ceiling-Mounted) to the designated OR.

Pre-Planning

Before any Buzz Navigation (Ceiling-Mounted) solution is confirmed or scheduled forinstallation, Brainlab customer consultants must be involved.All customer information (name, address, designated contact persons, status of the OR, interfacedevices, plan and section of OR and surrounding rooms) must be provided to the Brainlabcustomer consultant for pre-planning and preliminary layout proposals.The following information must be provided in order for the Brainlab customer consultant to begin:

Information Type Category Details

Contact

Project address, hospital, depart-ment

Name, country, address, phone,email

Contact person (customer)

Name, address, phone/fax, emailOn-site architect, responsible facilitymanager

Other applicable local parties, firms,engineers, etc.

Site

Designated OR Room number, floor, wing

Status of OR Existing, planned, in use, not inuse

Estimated date for clinical use Date

Interface devices for live navigation/integration

Type, manufacturer (e.g., ZeissPentero microscope), output sig-nal/connection type.

Drawings (AutoCAD2000.dwg)

Plan of designated OR and sur-rounding rooms All architectural and equipment in-

formationCross section of designated OR andsurrounding rooms

Planning Phase

A preliminary layout proposal will be drafted by Brainlab and sent to the customer and/or assignedarchitects. This layout must checked in detail by the customer (both users and technicalrepresentatives of the customer), especially with respect to the position of the central ceiling axisof the arm selected system and the area covered by ceiling-mounted devices (display, cameraand OR lamps, if applicable).The proposed location of the 42" Display, ceiling-mounted devices, Connection Unit and the MCUmust be approved by the customer.Based on the Brainlab layout proposal, local drawings for the ceiling mount (substructure andinterface plate) must be prepared by the customer and their engineer.

On-Site Visit

The Brainlab customer consultant, the customer and the local architects must agree on:• The reworked Brainlab OR layout (including all devices)

Project Phases


• All technical issues (ceiling substructure, final location of devices, etc.)• A timeline (next steps, possible delivery, and installation date)• The scope of work packages for all involved parties and trades (if required)

Detailed Planning

Brainlab completes a detailed set of planning drawings, which must be approved (i.e., “signed off”)by the customer. The detailed project timeline is issued by Brainlab and must be confirmed by thecustomer.

Production

This is the preparation phase for the customer, Brainlab and other involved parties. In this phasethe following points are achieved:• Issuance of final layout drawings by Brainlab• Brainlab orders site-specific parts; preassembly and testing in Germany• On-site preparation by customer, as specified in the Brainlab planning drawings• On-site shipment of all Brainlab components

Pre-Installation

This is the first fixation of intermediate ceiling substructure. Pre-installation must be done beforethat main installation of the arm system and before closing the false ceiling.

Installation

This phase includes the on-site installation of Brainlab components by Brainlab as well as systemintegration and testing by Brainlab installation engineers.

Acceptance

This milestone covers the system installation acceptance and commissioning procedure betweenBrainlab and the customer.

Training

Brainlab support provides device and maintenance training, as well as acceptance and usertraining.

Acceptance Training

This milestone covers the clinical training acceptance procedure of the system and application byBrainlab personnel with the user. Only after the successful Brainlab product training and trainingacceptance is the Brainlab system released for clinical use by the user.

IMPLEMENTATION


7.3 Scope of Customer Work

General Information

In order to guarantee best practices and a short implementation period, certain requirements mustbe fulfilled by the customer prior to the Brainlab installation. Below is an overview of a typicalscope of work. This shall be covered either by the customer or local contractors employed by thecustomer.Refer to the site-specific planning drawings for further details. These drawings are submitted andrefined in the course of the project implementation.

Ceiling Superstructure/Substructure

• Customer scope of work of according to arm supplier specifications including the weight ofBuzz Navigation (Ceiling-Mounted) components.

• Ceiling mount design and respective superstructure/substructure approval, preparation andmounting according to arm supplier specifications.

• Structural/static approval by structural engineer of record.• Any substructure design, preparation and installation necessary to support the mounting

system of the arm supplier.

Duct Work/Conduits

• Conduit implementation according to the Brainlab drawings.• Inner diameter of 40 mm [1.57"] (unless defined otherwise; refer to the site-specific Brainlab

drawings).• All conduits prepared with pull wire (minimum bending radius of 300 mm).• Cable grommets at end of conduits.• Cable duct preparation as specified in the Brainlab planning drawings.

Installation Hatch

On-site preparation in the ceiling according to the Brainlab drawings.

Electrical/Power

• Power outlets as specified in the Brainlab planning drawings.• Potential equalization connectors provided can be connected to a potential equalization point in

the OR.

Networking

• 1 x RJ45 network points as defined in Brainlab planning drawings.• Access to the hospital PACS network shall be provided to Brainlab (issue IP address).

Protective Earth connections / Potential Equalization

Grounding points within the operating room as specified in the Brainlab planning drawings.

CSU Pendant

All modifications required to place the Connection Unit onto the CSU pendant as specified in theBrainlab planning drawings, such as power plug, grounding point (PE), blanks plate for feedingcable through or connector plates (if applicable).

Scope of Customer Work


Preparation for Connection Unit and Computer Unit Positioning

Refer to Brainlab planning drawings for Connection Unit and Computer Unit positioning, andprovide any required equipment therefore (e.g., providing power, shelves, CSU).

Ventilation

Ensure that adequate ventilation is provided to meet the environmental requirements of thespecific Brainlab product.

IMPLEMENTATION


Scope of Customer Work


8 APPENDIX8.1 Appendix

References

• Technical requirement sheet for Buzz Navigation (Ceiling-Mounted) arms systems• Buzz Navigation (Ceiling-Mounted) System and Technical User Guide• Brainlab Cleaning, Disinfection & Sterilization Guide

Cleaning and Disinfection

Refer to the Buzz Navigation (Ceiling-Mounted) System and Technical User Guide.

Abbreviations

Abbreviation Explanation

AWG American Wire Gauge

CR Control room

CSU Ceiling supply unit

EQR Equipment room

FO Fiber optic (cable)

IGS Image-guided surgery

iMRI Intraoperative magnetic resonance imaging

LC Optical fiber connector

OM2 / OM3 Multimode fiber

OR Operating room

PCAP Projected capacitive touch technology

PE Protective Earth

POAG (Potentialausgleich) Potential Equalization

SELV Separated extra-low voltage

APPENDIX


Appendix


INDEXNumerics

42" Display................................................................................. 23

Aadditional mains switch.............................................................. 88arm requirments....................................................................... 103

Ccables......................................................................................... 45cabling........................................................................................ 42camera

field of view.............................................................................27ceiling requirements................................................................... 81ceiling supply unit (CSU).......................................................... 106ceiling-mounted (CM) camera.................................................... 24ceiling-mounted (CM) display.....................................................26client responsibility..................................................................... 14components................................................................................15connection panel........................................................................ 20connection unit........................................................................... 29converter box..............................................................................34coupling box............................................................................... 36current........................................................................................ 73

Eenvironmental conditions............................................................74ethernet...................................................................................... 75external mains switch................................................................. 88

Ffield of view

camera....................................................................................27functions..................................................................................... 15

Hhardware ports........................................................................... 19

LLAN connection.......................................................................... 38LAN specification........................................................................75layout..........................................................................................61liability...........................................................................................8

Mmain display............................................................................... 23medical computer unit (MCU).....................................................18

ports........................................................................................19MR environment......................................................................... 98

Ooperating conditions................................................................... 74

Ppanels

connection panel.................................................................... 19patch field................................................................................... 35patient environment....................................................................61ports........................................................................................... 19potential equalization..................................................................40power consumption.................................................................... 73power outlets.............................................................................. 41pre-installation.......................................................................... 109project time line........................................................................ 121

Rrack.............................................................................................92

Ssize............................................................................................. 72storage conditions...................................................................... 74supply unit.................................................................................. 32support numbers.......................................................................... 7

Ttime line.................................................................................... 121transport conditions.................................................................... 74

Vventilation................................................................................... 94voltage........................................................................................73

Wweight......................................................................................... 72wireless LAN.............................................................................. 39

INDEX


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MOUNTED) (CEILING- NAVIGATION BUZZ - Brainlab User Guides

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