NavSuite Navigation Kits Ref 7700-009-xxx Instructions for Use Rev G May 2008

Intended Use of the Navigation System The Navigation Kit for NavSuite™ allows the Navigation System II-Camera REF 7700-500-000 and a flat panel monitor to be ceiling-mounted on flexible arms so that the camera and monitor can be positioned independently for optimal system flexibility. The NavSuite™ includes a computer workstation, a control unit for data input, camera, and the navigation suspension as the articulated camera arm. The Rover Navigation Kit for NavSuite™ allows the ceiling-mounted Navigation System II-Camera and a flat panel to be connected to the I/O panel of the Navigation System II-Cart REF 7700-100-000. The navigation suspension is intended to be used as the articulated camera arm. For additional information on the intended use of the Navigation System II, refer to the Instructions for Use supplied with the camera. For further specifications, refer to the intended use of the navigation software modules included in the Safety Information supplied with the software modules.



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User/Patient Safety WARNINGS: • Read and understand this information, file it in your maintenance records. Familiarization with the Stryker® Navigation System prior to its use is important. Only trained personnel are to use this system. • Before using any component compatible with the system, read and understand the instructions. Pay special attention to the user/patient safety information provided in the Instructions for Use supplied with the components. Failure to comply may result in patient and/or operating room staff injury or damage to the system components. • Prior to each use, the system should be checked for loose components and damage. DO NOT use if these conditions exist. If service is required, contact your Stryker Navigation sales representative. • To prevent overheating, do not place the system in proximity of heat sources such as radiators or air ducts. • Refer to the Instructions for Use for the Navigation System II-Camera to read the user/patient safety information related to the camera. • To avoid product damage, do not place bottles with liquids on any part of the system. Spilling liquids on any electrical device attached to the system should warrant inspection by an authorized Stryker service technician. • To avoid product damage and/or unintentioned motion of the camera arm, do not hang weights on the articulated arms. • Prior to surgery, the system should be checked with the navigated instruments to ensure that the equipment is functioning properly. • Do not service this device. The system does not contain any parts the user can service. If service is required, contact your Stryker Navigation sales representative.

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• To avoid operating room staff/patient injury, avoid collisions above the surgical field during the procedure. • Performing procedures with system other than those specified in these instructions or outside of its intended use will compromise the navigation accuracy. • Clean and inspect the system before first and every use. Refer to the Cleaning and Sterilization Instructions contained in this manual. • Take special precautions regarding electromagnetic compatibility (EMC) when using this medical electronic equipment. Install and put the equipment into service according to the EMC information in the EMC Specifications Manual REF 6000-005-770. This medical equipment meets all requirements in the IEC 60601-1-2 standard and can be installed in a normal environment. The equipment must not be placed or installed close to strong electromagnetic sources which may influence the function of this equipment. • This equipment is not suitable for use in the presence of flammable anesthetic mixtures with air, oxygen or nitrous oxide. • Excessive infrared radiation from external sources can influence localization of the instruments by the Navigation System. Refer to the Navigation System II-Camera Instructions for Use. • Use only Stryker approved components and accessories. Other components or accessories may not properly interface with the system or may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. Contact your Stryker Navigation sales representative for more detailed information. • To avoid injury to fingers and/or hand, use the handle of the articulated arm for repositioning. • The user must not make simultaneous contact with patient and NavSuite.

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• To avoid operating room staff injury and/ or product collision/damage, ensure that the NavSuite arms are always returned to the upper position when not used. • To avoid operating room staff injury and/ or product damage, prior to moving the camera and/or monitor always ensure that no obstacle may collide with the camera/monitor/arms. • Refer to the Instructions for Use supplied with the NavSuite components for safety notes related to each component. • Colission between the navigation camera and spring arm may occur when the camera is pushed up towards the ceiling. Prevent such colissions. • Do not place the system near equipment that generates a magnetic field as stored patient data can be erased. • The integration of system components and accessories must comply with IEC 60601-1 and IEC 60601-1-2. Other accessories may not properly interface with the system. Contact your Stryker Navigation sales representative for more detailed information. • The final responsibility for proper installation of the NavSuite lies directly with the party charged with the system integration. The system integrator is responsible that adapted medical devices fulfill all requirements according to the Medical Device Directive 93/42/EEC article 12.

Specifications* REF 7700-009-010 Navigation Kit for NavSuite™ REF 7700-009-020 Rover Navigation Kit for NavSuite™ Size: 17,0 cm [6.6 in] height 24,5 cm [9.64 in] width 46,5 cm [18.30 in] length Weight: 20,5 kg [9.28 lb] Firewire cable: maximum length 1.8 m Approvals: CSA International CAN/CSA-C22.2 No. 601.1-M90 IEC 60601-1 EN 60601-1 IEC 60601-1-2 EN 60601-1-2 US UL 60601-1 04 Material: stainless steel (transformer) Power supply: 100-120V ~ 50-60 Hz 9,5 A 220-240V ~ 50 Hz 4,3 A Enclosure protection: IPX0 Ordinary Equipment Equipment Type: Class I Operation:

CAUTIONS: • DO NOT use any part of the system for loading, transport or storage unless otherwise specified. Failure to comply may lead to product damage and malfunction. Storage and Transportation:

* Specifications listed are approximate and may vary slightly from unit to unit. Standards listed are valid unless a transition period may be applicable.



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Function and Features Navigation System II-Camera • REF 7700-500-000 • Communicates the coordinate location of the navigated instruments to the system. It identifies the location and orientation of one or more instruments in three dimensional space. Monitors • Display patient images for surgeon and operating room staff during the surgical procedure. • 1280 x 1024 pixel monitor, part of the computer workstation. • 1280 x 1024 pixel monitor to be mounted onto the ceiling. MO Drive Interface • MO drive can be used for magneto-optical data transfer.

Camera Handle • Use to position the camera for optimal alignment towards patient/instruments. Reusable Handle • REF 0682-000-181 • Must be used to reposition the camera within the sterile surgical field. For further details, refer to the information supplied with the reusable handle. Keyboard • User interface to navigation software. Keyboard Protector • Used to protect the keyboard against spilling of liquids. DVD Drive • Used for data transfer on digital versatile disc.

Mouse • Enables operating room staff to interface with the navigation software.

Camera Handle Figure 1: Ceiling-Mounted Camera

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Figure 2: Ceiling-Mounted Flat Panel Monitor  �

I/O Panel NavSuite™ �������������������������� I/O Panel relevant connections for Navigation Kit • Used to switch system on/off • Used to connect: - USB 2.0 - Ceiling-mounted camera via Firewire - Network - Fluoro C-arm via BNC - Endoscope via S-Video - Monitor via VGA/DVI

NavSuite™��������������������������� I/O Panel relevant connections for Rover Navigation Kit • Used to switch system on/off • Used to connect the Navigation System II-Cart with: - Ceiling-mounted camera via Firewire - Ceiling-mounted monitor via VGA

Power Switch

Figure 3: NavSuite I/O Panel Connections for Navigation Kit

Figure 4: NavSuite I/O Panel Connections for Rover Navigation Kit 

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Isolation Transformer REF 7700-009-300 Power Outlets • Multiple sockets can be used for power supply. • See Specifications.

Power Outlets

Figure 5: Isolation Transformer

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Instructions for Navigation Kit 1 Initialize 1.1 Turn on the system by pressing the power switch at the I/O panel. See figure 3 and 4. 1.2 Log in. 1.3 Start the application. 1.4 Load or enter patient data. 2 Setup and Intraoperative Use 2.1 Use the reusable handle for camera repositioning within the sterile surgical field. 2.2 Use the flat panel handle to reposition the ceiling-mounted monitor. 2.3 Use the keyboard/mouse to input data from outside the sterile surgical field.

3 Setup and Intraoperative Use 3.1 Use the reusable handle for camera repositioning within the sterile surgical field. 3.2 Use the Cart keyboard/mouse to input data from outside the sterile surgical field. 4 System Shutdown 4.1 Turn the Cart off by pressing the Cart power switch. Refer to Instructions for Use supplied with the Cart. 4.2 Turn the system off by pressing the NavSuite I/O panel power switch for at least 3 seconds. See figure 4. 4.3 Return the flat panel and the camera arms to the upper position.

3 System Shutdown 3.1 Turn the system off by pressing the power switch. See figure 2. 3.2 Return the flat panel and the camera arms to the upper position.

Instructions for Rover Navigation Kit 1 Connect 1.1 Connect the Navigation System II-Cart to the NavSuite I/O panel via Firewire and VGA. Refer to figure 4. 1.2 Before starting the application disconnect the firewire cable from the camera mounted on the Navigation System II-Cart. Refer to the Instructions for Use supplied with the camera. 2 Initialize 2.1 Press the power switch at the NavSuite I/O panel. Refer to figure 4. 2.2 Initialize the Navigation System IICart. Refer to Instructions for Use supplied with the Cart.



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Symbol Definition

Precautionary Information

CSA International

This label is located on top and on the side of the isolation transformer.

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste. The product should be collected separately. Refer to your local distributor for return and/or collection systems available in your country.

CE conformity: Essential Requirements of Medical Device Directive 93/42/EEC.

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Troubleshooting Guidelines Camera is not working: • Power cable/firewire cable is not connected, defective or loose. Check connections. Plug in power cable. Reset cable connectors at the camera. Call for service, if required. • Main power interruptor is off. Turn on the main power interruptor. See figure 5. • Voltage selector is not set correctly. Verify that the voltage selector is properly set. See figure 6. • Fuses are tripped. Verify that the fuses are not tripped. • Camera/connection is defective. Call for service. • Firewire cable of camera is still connected to Cart. Disconnect the firewire cable from the camera mounted on the Cart.

Fuse (2x) Voltage Selector

Main Power Interruptor

Figure 6: Main Power Interruptor Located on the Isolation Transformer

Monitor/camera articulated arm drifts upward or drops: • Arm tension requires adjustment. Call for service.

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Cleaning and Sterilization Instructions CAUTIONS: • DO NOT allow moisture to enter any opening of the isolation transformer. Fluids/moisture may damage the electrical components. • Please observe the monitor/keyboard manufacturer’s care instructions and special safety/caution notes. Cleaning Instructions for Camera For instructions related to the camera, refer to the Instructions for Use supplied with the camera. Cleaning Instructions for Monitor and Keyboard 1. Clean only if required. 2. Clean the whole surface using a lint-free soft cloth lightly dampened with an alcohol-free cleaning fluid suitable for computer screens and/or keyboards. 3. Polish the cleaned surface. Cleaning and Sterilization Instructions for the Reusable Handles For cleaning and sterilization of the reusable handles, refer to the respective instructions of the reusable handles. Refer to the Guide for Cleaning and Steam-Based Sterilization REF 6000-005-750 for cleaning safety and caution notes, cleaning equipment and detailed cleaning and sterilization instructions intended for instruments with electronics.

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Translated Equivalent: 7700-009-713

Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany t: +49 761 4512 0 Distributed by: Stryker Navigation 4100 East Milham Avenue Kalamazoo, MI 49001 USA t: +1 269 323 7700

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