Page 2 Permission is hereby granted, free of charge, to any person obtaining a copy of the fonts feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark accompanying this license ("Fonts") and associated documentation files (the "Font Software"), to or other intellectual property rights concerning that name or logo.
Page 3 Chapter 1 Health and Safety Compliance ................. 1 Important Information ..........................1 Intended Use ............................. 1 Overview of the SPY-PHI System ......................3 User Qualifications ............................ 4 General System Safety ..........................5 Electrical Safety – General ............................ 5 Electrical Safety – Power............................5 Light Safety- Illumination ............................
Page 4 Flipping the Display Image 180° ......................57 Recording Video ............................59 Recording Video on the Stryker SDC3™ HD Information Management System ..........59 Recording Video on Sony 1000MD and Sony 3300MT Recorders ..............61 Recording Video on TEAC UR-4MD Recorders ....................62 Capturing Screenshots ..........................
Page 5 Service ................................76 Language Setting ..............................78 Chapter 8 Cleaning the SPY PHI Imager ................79 Preparation .............................. 79 Cleaning SPY-PHI Components ......................79 Disinfecting SPY-PHI Components ......................79 Inspecting SPY-PHI Components ......................80 Storage ..............................80 Appendix A: Troubleshooting ....................81 Clearing SPY-PHI Imager, Illumination, and Recorder Errors ..............
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Page 7 Keep this manual in a safe, accessible location. Questions or comments about any information in this manual should be sent to Stryker Customer Support. The words WARNING, CAUTION, and Note carry special meaning and the associated clauses should be carefully reviewed: WARNING: Indicates risks to the safety of the patient or user.
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Page 9 The SPY-PHI System is configured as shown in Figure 1 and includes the following components: ▪ SPY Portable Handheld Imager (HH9030) with integrated light guide and camera cables, optimized for VIS/NIR imaging ▪ Video Processor/Illuminator (PC9001) capable of providing VIS/NIR illumination to the SPY-PHI imager via its light guide cable and the image processing required to generate simultaneous, real-time HD-video color and NIR fluorescence images...
Page 10 The SPY-PHI System is used in conjunction with the following consumable products: ▪ sterile drape ▪ ICG imaging agent Medical-grade accessories, which may be used to support the SPY-PHI System include: ▪ medical-grade video monitor ▪ medical-grade video recorder ▪ articulating arm ▪...
Page 11 WARNING: To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth. CAUTION: Do not use or store liquids around the VPI. If liquid enters the VPI, immediately turn system off and unplug it from the power outlet. Do not insert objects into the ventilation holes of the VPI enclosure.
Page 12 WARNING: Avoid looking at light emitted directly from the SPY-PHI imager. Table 13 in Appendix C contains specifications for the NIR radiation emitted in Fluorescence mode. Use of controls or performance of procedures other than those specified herein may result in hazardous radiation exposure. A laser aperture label is located on the top surface of the imager as prescribed by applicable standards (see Figure 2).
Page 13 SPY-PHI imager and system VPI are labeled with the following laser safety warning labels in accordance with applicable standards: Table 1: Images and Locations of Laser Warning Labels Top of SPY-PHI imager, see Figure 2. VPI, front panel, see Figure 9. The Video Processor/Illuminator used with the SPY-PHI imager is a component that is shared with the PINPOINT Endoscopic Fluorescence Imaging System.
Page 14 For further information and guidance refer to “Guidance and Manufacturer’s Declaration – Electromagnetic Compatibility” included with the SPY-PHI System. If the imaging system becomes unresponsive and does not resume normal function after turning off and back on, stop using the imaging system, and contact Stryker Customer Support. WARNING: Do not use the SPY-PHI imager if any part of the system is damaged or does not function properly.
Page 15 If an irregularity appears to be minor, refer to Appendix A -Troubleshooting. If the irregularity cannot be resolved, contact Stryker Customer Support. In the case that any component of the SPY-PHI System needs to be returned to NOVADAQ please adhere to the following: ➢...
Page 16 The following section describes symbols and indicators that appear on the SPY- PHI imager and VPI. Table 2: Symbols on the SPY-PHI Imager Turn laser on/off (green button) Button pad Display Mode (grey button) Button pad Tools menu button (grey button) Button pad Focus (upper blue button) Button pad...
Page 17 Table 3: Symbols on the Video Processor / Illuminator (VPI) and on System Labeling Rear panel, power Power On switch Rear panel, power Power Off switch Stand-by mode Front panel Laser on Front panel Type CF patient-applied part* Front panel Illumination on/off Front panel White balance...
Page 18 Accompanying General Warning Documentation Laser Warning Front panel Manufacturer Rear panel Date of manufacture Rear panel Accessory Reference or Model name/number Packaging Accessory Serial number Packaging Accessory Lot number/Date code Packaging Accessory Made in Germany Packaging Accessory Made in Canada Packaging Accessory Made in USA...
Page 19 Equipotential symbol Rear panel SGS Q-mark Rear panel CE Marking declaring EU Directive compliance Rear panel Accompanying Authorized European (EC) Representative Documentation Accompanying Medical Device Documentation Table 4: Onscreen Symbols in the Software Interface Standby mode See Chapter 6 White light mode See Chapter 6 Illumination failed error Appendix A...
Page 20 White balance completed See Chapter 7 White balance failed See Chapter 7 Video recording in progress See Chapter 7 Video recording paused See Chapter 7 Video recording in progress (TEAC UR-4MD See Chapter 6 recorder) Video recording paused (TEAC UR-4MD recorder) See Chapter 6 Video recording stopped (TEAC UR-4MD recorder) See Chapter 6...
Page 21 Button action- Screenshot captured See Chapter 7 Tools menu – Image flip See Chapter 7 Tools menu – Video recording See Chapter 7 Tools menu – Video recording device unavailable See Chapter 7 Tools menu – Screenshot See Chapter 7 Tools menu –...
Page 22 (part of menu Green feature) Below “White Green Select Balance” button A laser-on indicator light is also located on the SPY-PHI imager. 4-0003045 Rev. G...
Page 23 WARNING: If any items are missing or damaged, do not use the SPY-PHI System and contact a Stryker service representative. Use Table 6 to identify and inspect all SPY-PHI System parts before setting up the system. Table 6: List of SPY-PHI System Parts...
Page 24 WARNING: The SPY-PHI System has been certified for compliance with international standards for electromagnetic compatibility (EMC). The imaging system generates radio frequency energy and should be installed and used in accordance with the instructions in order to minimize the possibility of interference with other electro-medical equipment. However, there is no guarantee that interference will not occur in any particular installation.
Page 25 WARNING: All electro-medical devices connected to the imaging system must be certified medical-grade and all interconnected configurations shall comply with the IEC 60601-1 system standard. Failure to comply with this standard may result in unsafe operation of the system and/or injury to the patient or operator.
Page 26 Connect the VPI cables and components as shown in Figure 3. The connections on the rear VPI panel are described in Figure 4. Figure 3: SPY-PHI system wiring diagram showing connection to video monitors and recorder SDI co-axial cable VPI power cord SDI co-axial cable Medical video monitor power cord RS232 serial cable...
Page 27 Figure 4: Video Processor / Illuminator rear panel showing connectors and ports Main power switch RJ45 port (Communication port) Device identification label Ext. sync Potential equalization conductor SDI 1 video out Video format switch SDI 2 video out RS232 port (Communication port) DVI video out CAUTION: The communication ports on the rear panel are intended for use by NOVADAQ...
Page 28 There are several NOVADAQ-certified recorders for use with the SPY Portable Handheld Imaging System. Availability varies depending on region. Note: In order for the onscreen recorder controls and status to be visible to the operator during normal operation of the SPY-PHI System, the VPI SDI 1 video output must be connected to the SDI-IN connector on the recorder.
Page 29 Ensure that the video-format switch on the VPI is in the correct position for the recorder that is being used. The correct output formats are as follows: ▪ Stryker SDC3 HD Information Management System: 3G-SDI ▪ SONY 1000MD recorder: HD-SDI ▪...
Page 30 Insert the camera cable into the camera port on the VPI (see Figure 6). Figure 6: Connecting the SPY-PHI imager to the VPI Fully insert the end of the SPY-PHI imager light guide cable into the light guide port on the VPI and confirm that it is fully engaged (see Figure 6). WARNING: Avoid looking at light emitted directly from the SPY-PHI imager.
Page 31 ICG imaging agent is a sterile, water soluble tricarbocyanine dye with a peak spectral absorption at 800-810 nm in blood plasma or blood. ICG contains not more than 5.0% sodium iodide. ICG is to be administered intravenously. The Sterile Water for Injection, pH of 5.0 to 7.0, provided with the ICG is used to reconstitute the ICG.
Page 32 The Imaging System should not be used for NIR imaging during surgical procedures with patients who are known to be sensitive to iodides or iodinated imaging agents. WARNING: Anaphylactic deaths have been reported following ICG administration during cardiac catheterization. Each vial of ICG and accompanying Sterile Water for Injection are intended for use with only 1 patient and within 6 hours of reconstitution.
Page 33 Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, immediate treatment with the appropriate agents, for example, epinephrine, antihistamines, and corticosteroids should be administered. Resuscitative measures may also be required. WARNING: Do not use any ICG that has been reconstituted for more than 6 hours.
Page 34 ▪ 10 ml reconstituted ICG solution ▪ Sterile normal saline for injection ▪ 3 ml syringe ▪ 10 ml syringe ▪ 3-way stopcock For recommended dosage per procedure, see Table 7. Note: Dosing per procedure will vary based on the procedure and is determined at the discretion of the imaging surgeon.
Page 35 Prior to the NIR imaging procedure, withdraw the desired dosage of ICG solution for each planned imaging sequence into separate single use 3 ml syringes. With a single use 10 ml syringe, withdraw 10 ml of sterile saline. Switch to Fluorescence mode using the Illumination button on the SPY-PHI imager.
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Page 37 WARNING: Proper sterile technique must be used when preparing the SPY-PHI imager for surgical procedures. The following components are not sterile and should not be handled by a sterile operator: ➢ Video Processor / Illuminator (VPI) ➢ Undraped SPY-PHI imager and cables. WARNING: Use only the approved drape model.
Page 38 The following draping instructions must be followed: Non-sterile operator: Open the package containing the sterile drape. Non-sterile operator: Remove the wrapped drape from the pouch by grasping it between the folded paper insert. Do NOT touch the wrapping or the drape. 4-0003045 Rev.
Page 39 Sterile operator: Using proper sterile technique, take the wrapped drape from the non-sterile operator. Sterile operator: Place the wrapped drape on a sterile surface. Sterile operator: Unwrap the drape and place the sterile rubber bands to the side. SPY Portable Handheld Imaging System Operator’s Manual...
Page 40 Sterile operator: Grasp the drape, locate the opening, and insert one hand. Sterile operator: Using the hand inside the drape, grasp the lens by the edges and hold it firmly. CAUTION: Do not hold the lens by the lens-tabs. 4-0003045 Rev. G...
Page 41 Non-sterile operator: Present the SPY-PHI imager to the sterile operator, nose first, such that the lens is inserted into the front nose-piece of the SPY-PHI. Sterile operator: Use the hand inside the drape to press the lens firmly onto the front of the SPY-PHI imager. Sterile Operator: With the clip engaged, push the drape over the SPY-PHI imager.
Page 42 Non-sterile operator: Grasp the exposed end of the drape and pull the drape over the SPY-PHI imager. CAUTION: Touch ONLY the end of the drape. Non-sterile operator: Pull the drape over the entire length of the cables. CAUTION: The sterile operator must be careful not to accidently touch the undraped cables while the drape is pulled over the SPY-PHI imager and cables.
Page 43 Sterile operator: Wrap one sterile rubber band over the front of the imager and onto the handle to secure the drape. Sterile operator: Pull the drape taut around the lens so that no part of it is obscuring the imaging field. Sterile Operator: Wrap one sterile rubber band around the body of the imager.
Page 44 To remove the drape: Remove the sterile rubber bands. Squeeze the two tabs on the drape lens together and pull the imager away from the drape lens. When the clip has disengaged, carefully remove the SPY-PHI imager from the drape. Consumables should be disposed of in compliance with local, regional, and national regulations.
Page 45 The SPY-PHI imager is designed for single-handed operation with ergonomic controls. The size and weight of the SPY-PHI imager have been optimized to ensure user comfort during imaging. The buttons on the imager can be used to control all imaging functions, including: ▪...
Page 46 Figure 7: Overview of SPY-PHI imager controls and indicators Illumination button / Laser-on Menu / menu select button indicator Display mode / exit menu button Focus near (press and hold) / vertical menu navigation (up) button Focus far (press and hold) / vertical menu navigation (down) button The label locations on the SPY-PHI imager are shown in Figure 8.
Page 47 Figure 8: Overview of label locations on the SPY-PHI imager Laser aperture warning label Device ID label SPY Portable Handheld Imaging System Operator’s Manual...
Page 48 The VPI provides NIR and white light illumination, video processing, user interface, and other control capabilities for the SPY-PHI system. The front panel includes buttons for controlling the primary functions of the system, indicators for power and laser-on, and ports for the SPY-PHI light guide and camera cables (see Figure 9).
Page 49 The primary functions of the SPY-PHI System include: ▪ Powering on the system into Standby mode ▪ Focusing the image ▪ Turning Fluorescence Illumination on ▪ Selecting fluorescence display modes ▪ Toggling between Fluorescence and White Light Illumination modes ▪ Returning to Standby mode and powering off the system SPY Portable Handheld Imaging System Operator’s Manual...
Page 50 CAUTION: In order for it to initialize correctly, the SPY-PHI imager should be draped, and connected to the VPI, prior to powering on the system. To power on the system: Move the SPY-PHI System into an appropriate position for the clinical imaging procedure.
Page 51 Figure 10: Onscreen Standby mode icon Standby Mode To focus the video image during imaging: Hold the SPY-PHI imager 10 to 40 cm (4 to 15 inches) from the surface or tissue to be imaged. While viewing the image on the video monitor, press and hold one focus button at a time until a sharp and focused image is achieved (see Figure 11).
Page 52 Figure 12: Animated onscreen focus adjustment icon If the focus-stop icon displays, the focus has reached the end of its adjustment range. Press the opposite focus button. 4-0003045 Rev. G...
Page 53 WARNING: Avoid looking at light emitted directly from the SPY-PHI imager. In Fluorescence Imaging mode, the VPI provides near-infrared spectrum illumination through the SPY-PHI imager for viewing a fluorescence image on the system display. To turn on Fluorescence Imaging mode: ▪...
Page 54 Figure 14: Overlay mode with displayed Fluorescence mode icon Note: For best results, dim or turn away overhead and head-mounted surgical lights during fluorescence imaging. 4-0003045 Rev. G...
Page 55 In Fluorescence Imaging mode, three different display modes are available: ▪ Overlay mode – see Figure 15 ▪ SPY Color-Segmented Fluorescence (CSF) mode – see Figure 16 ▪ SPY mode – see Figure 17 In Overlay mode, an NIR fluorescence image is superimposed in pseudo-color (green) on a white light image.
Page 56 In SPY Color-Segmented Fluorescence (CSF) mode, a white light image is displayed in grayscale with NIR fluorescence overlaid in a color scale. Increasing fluorescence levels transition from blue to yellow to red. A color legend is provided on the right side of the screen.
Page 57 To select fluorescence display modes: ▪ Press the A button on the SPY-PHI imager (see Figure 18). The fluorescence display mode changes each time the button is pressed. Figure 18: Display mode button The mode selections are indicated by the icons at the top of the screen (see Figure 19).
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Page 59 The SPY Portable Handheld Imaging System enables the user to toggle between fluorescence imaging and white-light imaging at any time during a procedure. To toggle between Fluorescence mode and white-light mode: ▪ On the SPY-PHI imager, press the Illumination button The White Light mode activated icon displays in the top right corner of the screen for two seconds (see Figure 20).
Page 60 VPI rear panel) for five seconds and then switch the power on again. The SPY-PHI imager cables should remain connected to the VPI during this time. If the fault persists after cycling the power on and off as described, please contact Stryker Customer Support. 4-0003045 Rev. G...
Page 61 Secondary functions of the SPY-PHI System include: ▪ ° Flipping the display image 180 ▪ Starting and pausing video recording ▪ Capturing screenshots ▪ Performing a white balance ▪ Accessing the VPI Options menu SPY Portable Handheld Imaging System Operator’s Manual...
Page 62 The Tools menu provides access to additional functions at any time during imaging. When accessed, the tools menu displays on the left side of the video image. Figure 21: Overview of the Tools menu Flip display image Start and pause video recording Capture screenshot Perform white balance Access VPI Options menu.
Page 63 Figure 23: Tools menu Navigate the menu by pressing the focus/arrow buttons, (up) and (down). Press to activate the selected icon in the menu. To exit the Tools menu and return to a live image at any time, press the A button If required, the display image can be flipped 180°.
Page 64 Figure 24: Flip Display Image icon in the Tools menu The image inverts 180°. The image inverts each time the icon is toggled. An image flipped icon displays in the top-right corner of the screen as long as image flip is active (see Figure 25).
Page 65 Video recording can be started and paused from the Tools menu. Note: When using a MediCapture recorder, control from the Tools menu is not available. To start and pause video recording: Open the Tools menu by pressing the B button In the Tools menu, select the Record icon (see Figure 26).
Page 66 (see Figure 28). Figure 28: Recording-paused message If the recorder-unavailable icon displays, see Video Recording and Screenshot Errors on page 82. For more information about using the Stryker SDC3™ HD Information Note: Management System, see the device operating instructions. 4-0003045 Rev. G...
Page 67 To start and pause video recording: Open the Tools menu by pressing the B button In the Tools menu, select the Record icon (see Figure 29). Figure 29: Recording icon in the Tools menu Press the B button to start and pause recording. A recording icon displays in the top right corner of the screen during recording (see Figure 30).
Page 68 Figure 31: Onscreen recording-paused icon Note: When using the Sony recorder (PC9026), press the stop button on the recorder to stop recording and close the video case. If the recorder-unavailable icon displays, see Video Recording and Screenshot Errors on page 82. For more information about using Sony recorders, see the device operating instructions.
Page 69 4. To pause video recording, press the VIDEO/PAUSE button on the front panel of the recorder. A recording-paused icon displays on the screen. To resume recording, press the VIDEO/PAUSE button again. 5. To enable playback, press the CLOSE button on the front panel of the recorder.
Page 70 Figure 33: Capturing screenshots on the Stryker SDC3 system If the recorder-unavailable icon displays, see Video Recording and Screenshot Errors on page 82. For more information about using the Stryker SDC3™ HD Information Note: Management System, see the device operating instructions. 4-0003045 Rev. G...
Page 71 To capture a screenshot: Open the Tools menu by pressing the B button In the Tools menu, select the Screenshot icon (see Figure 34). Figure 34: Screenshot icon in the Tools menu Press the B button to capture the screenshot. The screenshot icon momentarily displays in the top right corner of the screen and the captured screenshot appears briefly in a picture-in-picture window in the lower-right corner of the screen, followed by the image number (see...
Page 72 Figure 35: Onscreen screenshot display If the recorder-unavailable icon displays, see Video Recording and Screenshot Errors on page 82. Note: For more information about using Sony recorders, see the device operating instructions. To capture a screenshot: 1. Open the Tools menu by pressing the B button 2.
Page 73 The color fidelity of the color image may be affected by external sources of white light, such as surgical lights, overhead lighting, or daylight. Performing a white balance optimizes the image so that white objects appear white. Perform a white balance if the image color fidelity appears inaccurate.
Page 74 Figure 36: Onscreen white balance icons White balance is active White balance completed White balance failed To perform a white balance from the SPY-PHI imager: With Illumination on, hold the SPY-PHI imager approximately 10 cm (4 inches) from a matte white surface, such as gauze or white cloth. Press the B button to open the Tools menu.
Page 75 Figure 37: White balance in the Tools menu Press the B button again to execute the white balance. Note: Illumination must be turned on to perform a white balance. SPY Portable Handheld Imaging System Operator’s Manual...
Page 76 The following settings and options can be configured from the menu (see Figure 38): ▪ Image Quality ▪ Display Options (PINPOINT Camera) ▪ Default Profile ▪ Load Profile (1-4) ▪ Save Profile ▪ Service ▪ Exit ▪ Language For more information about the VPI Options menu, refer to Appendix B. Figure 38: Options and settings that are available from the VPI Options menu 4-0003045 Rev.
Page 77 To access the VPI Options menu from the SPY-PHI imager: Press the B button to open the Tools menu. Press the bottom focus controls to navigate to the wrench icon in the list and press the B button again to open the VPI Options menu (see Figure 39).
Page 78 When the VPI Options menu is displayed on the monitor, it can be navigated using the buttons on the SPY-PHI imager. To navigate the VPI Options menu using the SPY-PHI imager: 1. With the VPI Options menu open, navigate by pressing the focus buttons, (up) and (down).
Page 79 Figure 41: Menu controls on the VPI front panel For more information about the VPI Options menu, see Appendix B. SPY Portable Handheld Imaging System Operator’s Manual...
Page 80 The following image quality settings are user-configurable. For a more complete description of these settings refer to Appendix B. Sharpening From 0 to 10 Larger values increase image sharpening Brightness From 0 to 255 Larger values increase image brightness Red Saturation From 0 to 1024 Larger values increase red saturation—...
Page 81 To select which fluorescence display modes shall be available to the user when using the system, complete the following steps: Press the Menu button on the front panel or select the VPI Options menu in the Tools menu Highlight Display Options and press the Right arrow button or the button to select.
Page 82 Save Profile allows the user to save a set of configurable settings for future use. These settings include: ▪ Display Modes ▪ Image Quality ▪ On-screen Info Up to 4 profiles are available. To save a profile, complete the following steps: Press the Menu button on the front panel or select the VPI Options menu in the Tools menu Highlight Save Profile and press the Right arrow button or the...
Page 83 1. Press the Menu button on the front panel of the VPI or select the VPI Options menu in the Tools menu 2. Highlight Service and press the Right arrow button or the button to select. 3. Highlight Recorder Setup and press the Right arrow button or the button to select.
Page 84 Press the Up or Down arrow button to choose the desired test pattern. Press the Right arrow button or the button to display the test pattern. Press the Right arrow button or the button to exit the test pattern when done.
Page 85 It is recommended that the imaging system components be cleaned after each use. Prepare components for cleaning using the following procedure: Turn off the power to the VPI. Remove and discard the drape (if applicable). WARNING: Failure to power off the VPI before starting to clean may expose personnel to unsafe conditions and result in damage to the system.
Page 86 Perform a check before and after each use. Do not continue to use a product that is damaged and/or incomplete or has loose parts. Contact Stryker Customer Support to send in the damaged product with loose parts to be repaired. Do not attempt to carry out any repairs on your own.
Page 87 WARNING: Do not use the SPY-PHI imager if any part of the system is damaged or does not function properly. Failure to follow this warning may lead to injury. The SPY-PHI System contains no user-serviceable parts. Do not attempt to open imaging system components.
Page 88 If the system detects an illumination failure, the illumination-failed icon displays (see Figure 43). If an Illumination-failed error occurs: Press the Illumination button on the VPI twice to clear the error. If the illumination fails a second time, turn off the system power off and contact a qualified NOVADAQ service representative.
Page 89 Figure 44: Recorder unavailable icon in Tools menu Recorder unavailable when video record selected Recorder unavailable when screenshot selected To select the recorder in the VPI Options menu, see Recorder Setup on page 76. For more information about configuring Sony recorders, see Setting up the Sony 1000MD Recorder for Control from the VPI on page 83 or Setting up the Sony 3300MT Recorder for Control from the VPI on page 87.
Page 90 Using the arrow buttons on the front panel, navigate to Settings and press the ENTER button. In the Settings menu, select System Admin Settings and press the ENTER button. In the warning dialog box, select Confirm and press the ENTER button. 4-0003045 Rev.
Page 91 In the System Admin Settings menu, select Device Settings and press the ENTER button. In the Device Settings menu, navigate to the RS-232C 1 field, press the ENTER button. Select System Control from the list and press the ENTER button. SPY Portable Handheld Imaging System Operator’s Manual...
Page 92 Select Advanced and press the ENTER button. In the System Control Setting dialog box, in the Speed field, select 115200 bps from the list. 10. Select Apply and press the ENTER button. 11. In the Device Settings menu, select Apply and press the ENTER button. 12.
Page 93 To configure the Sony 3300MT recorder: Press the MENU button on the front panel of the recorder. The main recorder menu opens on the display. Using the arrow buttons on the front panel, navigate to Settings and press the ENTER button. In the Settings menu, select System Admin Settings and press the ENTER button.
Page 94 In the System Admin Settings menu, select Device Settings and press the ENTER button. Select the Control tab. In the RS-232C field, select System Control from the list. 4-0003045 Rev. G...
Page 95 Next to the RS-232C field, select Advanced and press the ENTER button. In the Speed field, select 115200 bps. SPY Portable Handheld Imaging System Operator’s Manual...
Page 96 10. In the Protocol Mode field, select HVO-1000MD. 11. In the System Control Setting dialog, click Apply. 12. In the Device Settings dialog, click Apply and then press the MENU button to exit. 4-0003045 Rev. G...
Page 97 For a general troubleshooting guide, see Table 8. Table 8: General Troubleshooting Guide Video image is dark, The VPI is not able to CAUTION: The SPY-PHI imager may be damaged Illumination button does communicate with the if it is connected to or disconnected from the VPI while it is not change the SPY-PHI imager.
Page 98 The video image appears The Brightness value is set In the VPI Options menu, check the Image Quality value for Brightness. too dark. too low. If the value is less than 175, increase the value. The video image appears The Red or Blue Saturation In the Options menu, check the Image Quality value for the Red or Blue too red or blue.
Page 99 Users can adjust displayed video image settings in the Image Quality menu. Increasing the sharpening value increases the degree to which the displayed video is sharpened. Video sharpening is an image processing feature and does not affect the focus of the SPY-PHI imager. The Sharpening setting can be set to any value between 0 and 10.
Page 100 Select Mean to set the brightness by weighting the adjustment more by the mean brightness of the scene and less by the brightest points. For example, use the Mean setting to set the brightness for viewing objects that are farther from the front of the SPY-PHI imager. Foreground objects may appear too bright to see detail.
Page 101 Entering the Properties / Service menu displays device-specific information. The information shown includes: ▪ DSP version ▪ Boot version ▪ FPGA version ▪ LCB version ▪ VPI serial number ▪ SPY-PHI imager version ▪ SPY-PHI imager serial number During fluorescence imaging, the imaging system offers up to three different video display options.
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Page 103 Table 10: VPI Specifications Light sources Spectrum Visible (VIS) Near Infrared (NIR) Type Light-emitting diode array NIR laser diode Inputs/Outputs Video output signals HD-SDI, 3G-SDI, DVI HD formats HD-SDI 1080i 59.94, 3G-SDI 1080p 59.94 Resolution (pixels) 1920x1080 Service port I/O RS-232 (D-subminiature 9-pin connector) Operator Controls Power on/off...
Page 104 Table 11: SPY-PHI imager Specifications Optical Image sensors CMOS HD sensor assembly HD format 1080p Aspect ratio 16:9 Physical Dimensions Height 136 mm, Width 88 mm, Length 122 mm Weight 495 g not including cables Cable length Environment Operating temperature +10 to +30°C Relative humidity 10 to 85%RH...
Page 105 Table 12: Equipment Classification Type of protection against Class 1 As per IEC 60601-1 electric shock Continuous Operation Degree of protection against IPXX moisture Laser class Class 3R As per IEC 60825-1 Complies with 21CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.
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Page 107 This Software End User License Agreement (“Agreement”) is between you the end user (“You” or “Your” as appropriate) and Novadaq Technologies ULC (“Novadaq”). THE PINPOINT SYSTEM INCLUDES PINPOINT SYSTEM SOFTWARE WHICH NOVADAQ IS PREPARED TO LICENSE YOU TO USE AS PART OF YOUR USE OF THE PINPOINT SYSTEM BUT ONLY ON THE TERMS AND CONDITIONS SET OUT IN THIS AGREEMENT.
Page 108: General Terms
Disclaimer. THE WARRANTY IN THIS SECTION 3 IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, ACCURACY, AND ANY WARRANTIES THAT MAY ARISE OUT OF COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.
Page 109 Indemnification. Each party shall indemnify, defend and hold harmless the other party, its successors and assigns and their respective directors, officers, employees and agents from and against any and all liabilities, damages, losses, settlements, penalties, fines, costs and expenses, including, without limitation, reasonable attorneys’ fees of whatever kind or nature (but not including taxes), to the extent arising from any third-party claim, action, suit or proceeding based upon: (a) the indemnifying party’s negligence or misconduct in the performance of its obligations or exercise of its rights under the Agreement, and (b) the indemnifying party’s breach of the Agreement;...
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Stryker SPY PHI HH9000 Operator's Manual

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Page 108: General Terms