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Installation Protocol

Table of Contents

Page 2 of 16

Change Record

Revision Comment Date Author A Initial version 16. Oct 2006 RAS B Added iNtellect ENT Navigation,

reformatting 27. Nov. 2006 UB C Update for LWT Release 13. Nov. 2007 MEL

With the issuing of this document all previous revisions of the document are deemed invalid.

This document is property of Stryker Leibinger GmbH & Co. KG and is provided for internal use only. It is not intended for general distribution. Carefully read this document prior to installation. For informative background information, refer to the user documentation supplied with the product.

For detailed instructional steps to install related components, refer to installation instructions posted to the Technical Corner of www.strykereurope.com/navigation.

Table of Contents

1

Installation Site

... 3

2

Visual Checks

... 4

3

Functional Testing

... 5

4

General Safety Instructions

... 10

5

Training

... 11

6

Installation Summary

... 15

Page 3 of 16

1 Installation

Site

Hospital/City/Country: Customer No.:

Hospital Contact Person and Phone No.:

Customer Phone Line for Remote Service (Modem): Period of visit:

Visual Checks Page 4 of 16

2 Visual

Checks

Entire system and components are clean, free of severe defects, scratches, or gouges detrimental to the cosmetic quality of the finished product.

Visually inspect the inner compartment of the Cart/Laptop Stand under good light conditions for defects, misrouted or pinched cables, necessary or missing wire ties, or otherwise out-of-the-ordinary assembly practices.

Wheels. Ensure the Cart/Laptop Stand moves and turns as expected and there is no apparent grinding or unusual noise or excessive resistance. Check wheel locks function.

Page 5 of 16

3 Functional

Testing

Mechanics OK

Check camera and monitor(s) for secure position, proper tilt position and range of motion. Tilt feature must be able to be

repositioned by hand and sufficiently tight to support the weight of the component attached. For Navigation System II, refer to the installation instructions provided for REF 7700-100-000.

Computer HW / SW OK

Ghost Version and LOT:

Application iNtellect Crainial / ENT Navigation–SW Version and LOT: Functionality of: Monitor and Mouse

Attention: iNtellect Cranial/ENT supports the FP6000 camera, only.

System OK

If the Cranial / ENT Navigation software is not installed, perform installation in accordance with the Installation Instructions.

Check if the combination of the installed application software version, operating system version, hardware configuration is in accordance with the Navigation System Configuration Matrix (NASCOM).

Logon as “Navigation”.(no password). Click “iNtellect Cranial[ENT] Navigation”, The application starts.

Proceed to “System Setup”.

Turn on a smart instrument and validate it on the calibration device (a point calibration device or tracker is needed if the mask is used as patient tracker). Ensure that all tools are displayed in the graphics window.

Perform a CT scan of a phantom according to the Imaging Protocol described in the Navigation System Safety Information for Cranial / ENT Navigation. Transfer the images to the Navigation Computer and import the images into the Cranial / ENT Navigation Software. Examine the imported slices to ensure correct pixel size, slice position and image orientation.

Patient Registration and Tracking Mask

Apply a Patient Registration Mask to a phantom that has a shape similar to a human’s face.

Functional Testing

Page 6 of 16 Attach a communication unit to the mask.

Turn on the mask as patient tracker. Ensure that it is displayed in the graphics window.

Set the camera so that the displayed head appears in the center of the Optimal Working Space.

Perform a mask setup.

Microscope Kit

If a microscope has been integrated to the system, ensure that the microscope kit and the hose holder on the cart are properly installed. Ensure that the sticky markers “Calibrated Part Warning”

(REF 6000-054-703) have been appropriately placed on the microscope. Connect and turn on the microscope and place the microscope tracker in the field of view of the camera. Enter OR-Setup. Ensure that the

microscope connects automatically to the system and the microscope tracker is shown in the OR-Setup view.

With the microscope tracker connected use the OR-Setup to connect another smart instrument, e.g. Pointer 6000-11 or Small Pointer 6000-12, to validate the microscope calibration. Focus the microscope on the tip of the pointer and make sure that both, the microscope tracker and the pointer, are in the field of view of the camera. Ensure by looking through the microscope that during the microscope validation task a virtual green circle encircles the tip of the pointer.

Use a phantom and phantom data for navigation. Register using a smart instrument, i.e. Small Pointer 6000-12. Use the auto-focus to align the virtual crosshair cursor in the microscope’s field of view with a well known landmark on the phantom. Verify that the microscope focal point position is shown in the phantoms image data on the navigation screen within the accepted accuracy range.

The following checks apply if Cranial is installed onto a Remote Planning System

Verify that the navigation capability has been switched off on the remote planning system.

Verify that the associated navigation system is running the same

software version like the planning system (e.g. Cranial 1.1 and not an older version like Cranial 1.0, Neuro 2.0, Neuro 1.1 or Neuro 1.0). Plan a navigated surgery with segments, approaches and a registration on the remote planning system. Backup the patient data, transfer it to the associated navigation system and restore the patient data there. Verify that the data transfer has been completed correctly.

Verify on the navigation system that all the planning data of the patient has been transferred correctly.

Page 7 of 16 On the navigation system perform the registration, which has been

planned before on the remote planning system. Navigate the patient. Verify registration and navigation for correct and accurate functioning.

Functional Testing

Page 8 of 16

Smart Tools and Instruments

Program started as user “Navigation”, battery inserted into Smart Tools

OK

Mask Communication Unit, serial no.: 6001-380-000 LED(s) and related battery Button: SELECT

Patient Registration Mask:

LED check with Infrared LED Sensor Calibration Device type:

Calibration Device part no: Calibration Device serial no: LED(s) and related battery Buttons: SELECT, TURN CW (clockwise) and CCW

(counterclockwise)

LED check with Infrared LED Sensor Microscope Tracker(optional)

Part no.: Serial no.:

LED check with Infrared LED Sensor Additional Navigated Instruments Smart Instrument type:

Smart Instrument part no: Smart Instrument serial no: LED(s) and related battery

Buttons: SELECT, TURN CW and CCW

LED check with Infrared LED Sensor Smart Instrument type:

Smart Instrument part no: Smart Instrument serial no: LED(s) and related battery

Buttons: SELECT, TURN CW and CCW

Page 9 of 16

Smart Instrument type: Smart Instrument part no: Smart Instrument serial no: LED(s) and related battery

Buttons: SELECT, TURN CW and CCW

General Safety Instructions

Page 10 of 16

4

General Safety Instructions

OK

The user has been trained on the Safety notes, potential hazards and safety measures as described in Safety Information supplied with the system application software.

User/patient safety warning and caution notes as described in the Instructions For Use supplied with instruments have been carefully read and understood by the user.

The user understands that for safe and effective use it is necessary that the instructions for use including the cleaning, inspection, sterilization and maintenance recommendations as well as the storage and transportation instructions supplied with each instrument must be followed.

The functionality of the software user manual has been explained in order to access description of software information, error and warning messages and related corrective actions.

The importance of verifying the registration by performing a landmark test whenever a movement of the patient is suspected has been trained. The user is informed that the communication unit must not be autoclaved.

The user understands that the mask must not be distorted or moved relative to the patient’s face after the mask setup has been performed. This applies if the mask is used as patient tracker.

The user understands that the Patient Registration Mask is a single use device and must not be used repeatedly.

The user understands that the masks are for external use only. They must be used in the intended way only: e.g. applied to the face around the eyes and on the nose and nowhere else.

Masks may only be applied to healthy skin and must not come into contact with wounds, blood or other body fluids.

The user understands that no force must be applied to instruments when navigation is used for guidance. Any deformation of the tool compromises the accuracy.

The user understands that only tools suitable for navigation can be navigated by means of a tracker (e.g. no flexible shaft, bending or high vibrating parts).

Page 11 of 16

5 Training

In case of a new or an update software installation, train the staff. Explain features referring to the Release Notes and explain user settings.

The user understands that there are some requirements for Auto-registration that may not be required for other navigated applications. E.g.:

• The patient scan must include the nose and the top of head completely

• The patient orientation must be defined correctly during image import (e.g. x-axis = direction right ear; y-axis = direction nose; z-axis=direction top of head)

• The Patient Registration Mask must be used in the intended way (e.g. applied to face around eyes and on nose and nowhere else).

• System Setup: The camera should be positioned above the patient’s head looking down upon the patient. The angle defined by the camera and the patient’s Z-axis (pointing from feet to head) should be as close to 90° as possible.

When using a navigated microscope place the camera on the right side of the microscope so that the communication window is facing straight to the camera to optimize visibility of the microscope tracker. The recommended elevation of the camera is between the elevation of the patient tracker and the microscope tracker.

• Camera alignment: The patient tracker and the navigated instruments have to be in indicated working space of the navigation system. If a microscope is used, the microscope tracker must also be visible in the grey area.

• Draping of the microscope: The microscope drape has to be translucent and appropriate for Image Guided Surgery. Microscope vendors offer drapes

recommended for IGS. The microscope drape must tightly cover the LEDs of the microscope tracker minimizing the distance between drape and LEDs. It is

recommended to use a rubber band snapped over the tracker to pull the drape on the LEDs to get the most accurate results. Make sure sterile rubber band or tape is available during surgery. Refer to the IFU of the microscope tracker.

• Microscope Verification Task: Verify the accuracy of the data injection using the tip of the active tool (pointer) under the microscope. This task has to be

performed during surgery before trusting the data injection display. The System Setup tab can be raised at any time during surgery. Additional tests based on reference markers segmented as VOIs (Volumes of Interest) can be used during the case to verify the data injection accuracy including patient registration.

• Microscope Maintenance: Explain that the microscope tracker has been individually calibrated to work for this system. Explain that service on the

microscope can result in de-calibration of the microscope’s focal point navigation or data injection display. If the microscope has been serviced, Stryker Customer Support has to be informed before the system is used to verify or re-calibrate the microscope.

Training

Page 12 of 16 The following table lists items that require special attention:

Cranial System OK

Explain the different types of patient tracking devices (mask and other trackers). Explain that any patient tracking device can be used for Surface Matching and for point to point registration.

The user understands that Auto-registration is solely supported by the Patient Registration Mask. Explain how the mask must be tested before attaching it to the patient (status indicator on Communication Unit). Only if AIM Registration is licensed: Explain how the mask can be used for Automatic Intra-operative Mask Registration if an intra-operative CT scanner is used. Make sure the user understands the difference of Mask Registration (skin surface based) and AIM Registration (detected LED based). Make sure the user knows that the Mask must NEVER be MR-scanned.

Explain how the Patient Registration Mask is to be attached to the patient’s face. Explain how the Communication Unit is attached to the Mask. The user understands that the Mask and the Communication Unit together form a smart instrument and that they do not function if

separated (refer to the mask video in System Setup).

Emphasize the safety instructions concerning the mask usage (e.g. firm attachment, no movement, tracking device must stay stable during the entire procedure, external usage only).

Explain which part of the Mask is functioning as patient tracker and that any other LEDs are switched off after Mask Setup.

Explain that the Communication Unit must be secured to the patient’s head and must not distort the skin by tearing at the mask.

Explain the different registration methods (point-to-point, surface matching and Auto-registration).

Explain that the registration method must be selected on the Procedure Page.

Explain the Mask Setup procedure and show the single shot vs. multiple capture method.

Explain the meaning of the colored indicators for each mask LED (grey, red, green).

Explain the matching result dialogue (used LEDs for matching and the meaning of the deviation).

Emphasize the importance that the Mask must not move relative to the camera while taking the snapshots.

Emphasize the importance of the navigation accuracy confirmation. Explain that Surface Refinement can be used to improve any registration (if confirmation yields that this was necessary).

If Surface Refinement is used to improve an existing registration, no extra point set is required.

Explain the importance to choose rigid anatomical landmarks near the operation region if Point Registration is used.

Page 13 of 16

Cranial System OK

Inform about the importance of Rescue Points and how to define and use them. Explain that Rescue Points are not suitable to improve a

registration. They serve as a means to restore the current registration in case of unintended movement of the patient tracker.

Explain that live video images can be displayed (Home Page, Video settings …) and show how this is done.

Explain the full-screen navigation feature and how to configure it to the users needs (Home Page, User settings …)

Explain the automatic function to display the video image if actually navigation is not possible (because the involved tools are currently not visible, Home Page, System Settings …).

Explain that segments can be prepared in Planning and can be used in Navigation as a NoFly zone

Training

Page 14 of 16

Microscope Integration OK

Explain the importance of appropriate camera placement.

Explain the importance of good camera alignment using the System Setup.

Explain the appropriate draping of the microscope tracker for IGS. Explain the importance and how to use the microscope verification task (i.e. during System Setup).

Explain why Stryker has to be informed if the integrated microscope is maintained by other companies.

System training given OK

Name of Hospital Staff: Name of Hospital Staff: Name of Hospital Staff:

Instructions For Use or Important Information supplied with instruments taken notice of

Safety Information supplied with system application software taken notice of

Release Notes supplied with system application software taken notice of

Scanning Protocol supplied with system application software taken notice of

Software User Manual supplied with system application software taken notice of

Page 15 of 16

6 Installation

Summary

System installation for patient treatment has been: successfully completed

completed with following restrictions:

___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________

For the customer: For Stryker:

Name: Date/Place: Signature:

For internal use:

Update of the customer database o.k.

Final Remarks and Agreements

___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________

7

File in Maintenance Record

Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 D-79111 Freiburg / Germany t: +49 (0)761 4512-0 f: +49 (0)761 4512-120 Distributed by: Stryker Navigation 4100 East Milham Avenue Kalamazoo, MI 49001 USA t: 1 269 323 7700 t: 800 253 3210