Stryker SPY PHI HH9000 Operator'S Manual Download Page 105

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SPY Portable Handheld Imaging System

Operator’s Manual

Table 12: Equipment Classification

Type of protection against
electric shock

Class 1
Continuous Operation

As per IEC 60601-1

Degree of protection against
moisture

IPXX

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. 50, dated June 24, 2007.

Radio frequency emissions Group 1, Class A

As per CISPR 11

Harmonic emissions

Class A

As per IEC 61000-3-2

Table 13: NIR Radiation and Source Characteristics

Aperture for NIR radiation

SPY-PHI imager

Accessible NIR radiation

Wavelength

805 nm

Repetition rate

Overlay mode: 20 pulses/s

SPY mode: 40 pulses/s

Power output (maximum)

2 mJ/pulse as per IEC 60825-1

Pulse duration

Overlay mode: 8.33 ms

SPY mode: 10 ms

Beam divergence

50°± 5°

Embedded laser source

Classification

Class 4, invisible

Summary of Contents for SPY PHI HH9000

Page 1: ......

Page 2: ...CT INCIDENTAL OR CONSEQUENTIAL DAMAGES WHETHER IN AN ACTION OF CONTRACT TORT OR OTHERWISE ARISING FROM OUT OF THE USE OR INABILITY TO USE THE FONT SOFTWARE OR FROM OTHER DEALINGS IN THE FONT SOFTWARE...

Page 3: ...Setting up the System 17 SPY PHI System Parts 17 Setting Up the SPY PHI System 18 Selecting an Appropriate System Installation Location 18 Connecting to Ancillary Video Devices Optional 19 Connect the...

Page 4: ...Imaging 53 Returning to Standby Mode and Shutting down the System 53 Loss of Imaging During Use 54 Chapter 7 Operating the SPY PHI System Secondary Functions 55 Using the SPY PHI Tools Menu 56 Flippi...

Page 5: ...ding and Screenshot Errors 82 Setting up the Sony 1000MD Recorder for Control from the VPI 83 Setting up the Sony 3300MT Recorder for Control from the VPI 87 General Troubleshooting 91 Fuse Replacemen...

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Page 7: ...he safety of the patient or user Failure to follow warnings may result in injury to the patient or user CAUTION Indicates risks to the equipment Failure to follow cautions may result in product damage...

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Page 9: ...zed 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 simul...

Page 10: ...ch may be used to support the SPY PHI System include medical grade video monitor medical grade video recorder articulating arm medical cart WARNING This manual does not explain or discuss clinical pro...

Page 11: ...owered on WARNING Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked hospital only or hospital grade Connect the imaging system components only t...

Page 12: ...ified 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 Figure 2 Laser aperture on...

Page 13: ...althcare environments The imaging system generates radio frequency energy and should be installed and used in accordance with these instructions in order to minimize the possibility of interference wi...

Page 14: ...nresponsive 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 th...

Page 15: ...oubleshooting 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 followin...

Page 16: ...n pad Focus lower blue button Button pad Laser Aperture indicator Top of imager Manufactured by Device ID label bottom of imager Do not immerse in any liquid Device ID label bottom of imager Maximum t...

Page 17: ...de Front panel Laser on Front panel Type CF patient applied part Front panel Illumination on off Front panel White balance Front panel Menu Front panel Down part of menu feature Front panel Up part of...

Page 18: ...Accessory Packaging Serial number Accessory Packaging Lot number Date code Accessory Packaging Made in Germany Accessory Packaging Made in Canada Accessory Packaging Made in USA Accessory Packaging M...

Page 19: ...European EC Representative Accompanying Documentation Medical Device Accompanying Documentation Table 4 Onscreen Symbols in the Software Interface Standby mode See Chapter 6 White light mode See Chapt...

Page 20: ...rding in progress TEAC UR 4MD recorder See Chapter 6 Video recording paused TEAC UR 4MD recorder See Chapter 6 Video recording stopped TEAC UR 4MD recorder See Chapter 6 Display image currently rotate...

Page 21: ...pter 7 Tools menu Screenshot See Chapter 7 Tools menu Screenshot device unavailable See Chapter 7 Tools menu White balance See Chapter 7 Tools menu VPI Options menu See Chapter 7 Table 5 Indicator Lig...

Page 22: ...16 4 0003045 Rev G part of menu feature Green Up Below White Balance button Green Select 1 A laser on indicator light is also located on the SPY PHI imager...

Page 23: ...g up the system Table 6 List of SPY PHI System Parts Video Processor Illuminator VPI Model PC9001 SPY Portable Handheld Imager SPY PHI Model HH9030 Power cord HD SDI cable DVI cable SPY Portable Handh...

Page 24: ...ectro medical equipment despite being installed according to the instructions 1 Select a location in which to use the imaging system that is within 3 m access of an appropriate power outlet WARNING Re...

Page 25: ...e to comply with this standard may result in unsafe operation of the system and or injury to the patient or operator The VPI may be interconnected to other medical grade video devices such as Video re...

Page 26: ...the rear VPI panel are described in Figure 4 Figure 3 SPY PHI system wiring diagram showing connection to video monitors and recorder 1 SDI co axial cable 4 VPI power cord 2 SDI co axial cable 5 Medic...

Page 27: ...ualization conductor The potential equalization conductor can be used to equalize across multiple devices or to provide a redundant ground The potential equalization conductor is only to be used by qu...

Page 28: ...ectro 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 thi...

Page 29: ...rder 3G SDI TEAC UR 4MD recorder HD SDI or 3G SDI MediCapture USB300 recorder HD SDI or 3G SDI WARNING The following procedures must be performed using proper sterile technique if they are being perfo...

Page 30: ...Figure 6 Figure 6 Connecting the SPY PHI imager to the VPI 3 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...

Page 31: ...tered for use as a pharmaceutical product Contact your local distributor for more information on the availability of ICG at your location WARNING Refer to the ICG Package Insert prior to use Following...

Page 32: ...the ICG vial are sterile and must be handled aseptically to maintain the sterile field during surgery Radioactive iodine uptake studies should not be performed for at least a week following the use of...

Page 33: ...he surgical team Prepare ICG for administration as follows 1 Remove one 1 25 mg vial of ICG and one 1 10 ml vial of Sterile Water for Injection from the kit 2 Draw up the 10 ml Sterile Water for Injec...

Page 34: ...g per procedure will vary based on the procedure and is determined at the discretion of the imaging surgeon Table 7 Recommended ICG Dosage for Perfusion Assessment per Procedure Plastic Reconstructive...

Page 35: ...e prepared 3 ml syringe of ICG solution and one prepared 10 ml syringe of saline solution 3 Inject the prepared 2 5 mg ml ICG solution into the line as a tight bolus 4 Immediately switch access on the...

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Page 37: ...e WARNING Do not use the drape if the seals on the pouch appear compromised WARNING The drape is supplied sterile sterilized using ethylene oxide and must be handled aseptically to maintain sterility...

Page 38: ...tructions must be followed 1 Non sterile operator Open the package containing the sterile drape 2 Non sterile operator Remove the wrapped drape from the pouch by grasping it between the folded paper i...

Page 39: ...33 3 Sterile operator Using proper sterile technique take the wrapped drape from the non sterile operator 4 Sterile operator Place the wrapped drape on a sterile surface 5 Sterile operator Unwrap the...

Page 40: ...6 Sterile operator Grasp the drape locate the opening and insert one hand 7 Sterile operator Using the hand inside the drape grasp the lens by the edges and hold it firmly CAUTION Do not hold the len...

Page 41: ...ager to the sterile operator nose first such that the lens is inserted into the front nose piece of the SPY PHI 9 Sterile operator Use the hand inside the drape to press the lens firmly onto the front...

Page 42: ...ape over the SPY PHI imager CAUTION Touch ONLY the end of the drape 12 Non sterile operator Pull the drape over the entire length of the cables CAUTION The sterile operator must be careful not to acci...

Page 43: ...one sterile rubber band over the front of the imager and onto the handle to secure the drape 14 Sterile operator Pull the drape taut around the lens so that no part of it is obscuring the imaging fie...

Page 44: ...s 2 Squeeze the two tabs on the drape lens together and pull the imager away from the drape lens 3 When the clip has disengaged carefully remove the SPY PHI imager from the drape Consumables should be...

Page 45: ...sure user comfort during imaging The buttons on the imager can be used to control all imaging functions including Turning illumination on and off Selecting display modes Starting and pausing video rec...

Page 46: ...umination button Laser on indicator 3 Menu menu select button 2 Display mode exit menu button 4 Focus near press and hold vertical menu navigation up button 5 Focus far press and hold vertical menu na...

Page 47: ...SPY Portable Handheld Imaging System Operator s Manual 41 Figure 8 Overview of label locations on the SPY PHI imager 1 Laser aperture warning label 2 Device ID label 3 UDI...

Page 48: ...er on and ports for the SPY PHI light guide and camera cables see Figure 9 The rear panel includes the imager identification labels and inferface and power connection ports see Figure 4 Figure 9 Overv...

Page 49: ...f 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 Whi...

Page 50: ...itch on the rear panel of the VPI is turned to the on position If after confirming that the main power switch is in the on position the indicator still does not illuminate please consult Appendix A Tr...

Page 51: ...10 to 40 cm 4 to 15 inches from the surface or tissue to be imaged 2 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...

Page 52: ...46 4 0003045 Rev G 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...

Page 53: ...mode Press the Illumination button on the SPY PHI imager see Figure 13 OR Press the Illumination button on the front panel of the VPI see Figure 9 Figure 13 Illumination button on the SPY PHI imager...

Page 54: ...48 4 0003045 Rev G 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...

Page 55: ...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...

Page 56: ...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 Figure 16...

Page 57: ...e 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 The selected mode is always indicated by an icon in the upper ri...

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Page 59: ...White Light mode activated icon displays in the top right corner of the screen for two seconds see Figure 20 Figure 20 White Light Illumination mode icon White light mode To shut down the SPY PHI sys...

Page 60: ...n the front panel It is not necessary to power off the system using the main power switch on the back of the VPI If the SPY PHI System fails to produce continuous imaging switch the main power off on...

Page 61: ...g System Operator s Manual 55 Secondary functions of the SPY PHI System include Flipping the display image 180 Starting and pausing video recording Capturing screenshots Performing a white balance Acc...

Page 62: ...ge Figure 21 Overview of the Tools menu Flip display image Start and pause video recording Capture screenshot Perform white balance Access VPI Options menu For more information see Error Reference sou...

Page 63: ...return to a live image at any time press the A button If required the display image can be flipped 180 This is useful when the SPY PHI imager is mounted on a table mounted medical arm and reorientati...

Page 64: ...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 F...

Page 65: ...m the Tools menu is not available To start and pause video recording 1 Open the Tools menu by pressing the B button 2 In the Tools menu select the Record icon see Figure 26 Figure 26 Recording icon in...

Page 66: ...r of the screen when recording is paused see Figure 28 Figure 28 Recording paused message If the recorder unavailable icon displays see Video Recording and Screenshot Errors on page 82 Note For more i...

Page 67: ...ct the Record icon see Figure 29 Figure 29 Recording icon in the Tools menu 3 Press the B button to start and pause recording A recording icon displays in the top right corner of the screen during rec...

Page 68: ...re information about using Sony recorders see the device operating instructions To start and stop video recording from the Tools menu 1 Open the Tools menu by pressing the B button 2 In the Tools menu...

Page 69: ...e recorder If the record icon displays briefly and then disappears the TEAC recorder may not be selected in the VPI Service menu See Recorder Setup on page 76 For more information about using the TEAC...

Page 70: ...er in a picture in picture window bar see Figure 33 The screenshot will be automatically saved to the system Figure 33 Capturing screenshots on the Stryker SDC3 system If the recorder unavailable icon...

Page 71: ...e 34 Screenshot icon in the Tools menu 3 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...

Page 72: ...To capture a screenshot 1 Open the Tools menu by pressing the B button 2 In the Tools menu select the Screenshot icon see Figure 34 3 Press the B button to capture the screenshot The screenshot activ...

Page 73: ...n hold the SPY PHI imager approximately 10 cm 4 inches from a matte white surface such as gauze or white cloth 2 Press the white balance button on the front panel of the VPI An icon will appear in the...

Page 74: ...failed To perform a white balance from the SPY PHI imager 1 With Illumination on hold the SPY PHI imager approximately 10 cm 4 inches from a matte white surface such as gauze or white cloth 2 Press th...

Page 75: ...ble Handheld Imaging System Operator s Manual 69 Figure 37 White balance in the Tools menu 4 Press the B button again to execute the white balance Note Illumination must be turned on to perform a whit...

Page 76: ...e 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...

Page 77: ...to the wrench icon in the list and press the B button again to open the VPI Options menu see Figure 39 Figure 39 Accessing the VPI Options menu in the Tools menu 3 Press the B button again to open th...

Page 78: ...buttons in the VPI front panel can also be used to navigate the Options menu directly from the VPI 3 Press the A button on the camera to exit the VPI Options menu Note If no menu selection is made wi...

Page 79: ...SPY Portable Handheld Imaging System Operator s Manual 73 Figure 41 Menu controls on the VPI front panel For more information about the VPI Options menu see Appendix B...

Page 80: ...hat are closer to the front of the SPY PHI imager Select Mean to set the brightness by weighting the adjustment more by the mean brightness of the scene and less by the brightest points Select Balance...

Page 81: ...eselect To restore the Image Quality settings and Display Modes selections to the default settings complete the following steps 1 Press the Menu button on the front panel or select the VPI Options men...

Page 82: ...rrow button or the button to select 3 Press the Up or Down arrow button to choose the profile number to save to 4 Press the Right arrow button or the button to select the profile Selecting Service in...

Page 83: ...ner of the screen complete the following steps 1 Press the Menu button on the front panel or select the VPI Options menu in the Tools menu 2 Highlight Service and press the Right arrow button or the b...

Page 84: ...t arrow button or the button to exit the test pattern when done To change the language setting complete the following steps 1 Press the Menu button on the front panel or select the VPI Options menu in...

Page 85: ...equires cleaning use a small amount of glass cleaner and a soft cloth or gauze Do not use abrasive cleaners or strong solvents CAUTION Do not use caustic or abrasive cleaners that could damage the SPY...

Page 86: ...bels which are required for the safe and intended use must be legible WARNING Observe caution with a damaged and incomplete product injury to the patient operator or third parties is possible Perform...

Page 87: ...ing to a qualified NOVADAQ service representative As the system enters Standby mode the connected imager initializes If a communication error is detected the camera failed error icon will display and...

Page 88: ...alified NOVADAQ service representative Figure 43 Onscreen Illumination failed icon If the VPI is not configured for recording and Video Recording or Screen Capture is selected the icons in Figure 44 d...

Page 89: ...rs 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 If the Sony recorder is being installed for th...

Page 90: ...arrow buttons on the front panel navigate to Settings and press the ENTER button 3 In the Settings menu select System Admin Settings and press the ENTER button 4 In the warning dialog box select Conf...

Page 91: ...Manual 85 5 In the System Admin Settings menu select Device Settings and press the ENTER button 6 In the Device Settings menu navigate to the RS 232C 1 field press the ENTER button 7 Select System Co...

Page 92: ...NTER button 9 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 pre...

Page 93: ...n on the front panel of the recorder The main recorder menu opens on the display 2 Using the arrow buttons on the front panel navigate to Settings and press the ENTER button 3 In the Settings menu sel...

Page 94: ...88 4 0003045 Rev G 5 In the System Admin Settings menu select Device Settings and press the ENTER button 6 Select the Control tab 7 In the RS 232C field select System Control from the list...

Page 95: ...SPY Portable Handheld Imaging System Operator s Manual 89 8 Next to the RS 232C field select Advanced and press the ENTER button 9 In the Speed field select 115200 bps...

Page 96: ...0 4 0003045 Rev G 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 exi...

Page 97: ...ger 1 Check that the SPY PHI imager is properly connected to the VPI 2 Check that Illumination is turned on 3 Ensure that the front of the SPY PHI imager is 10 cm from a matte white surface such as ga...

Page 98: ...equency interference may be occurring between the imaging system and the malfunctioning equipment 1 Check to see if any of the following resolve the problem Reorient or relocate the imaging system or...

Page 99: ...0 and 255 Increasing this value increases the brightness of the video displayed on the monitor Increase the Red Saturation value to increase the overall redness of the video displayed on the monitor...

Page 100: ...y balancing the Peak and Mean settings For example use the Balanced setting when viewing objects both near to and farther away from the front of the SPY PHI imager Balanced is the default setting and...

Page 101: ...played The Overlay image display combines the white light image and the NIR fluorescent image In this mode the NIR fluorescence appears green on top of a high definition white light image In this imag...

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Page 103: ...panel switch Standby Front panel button White light Fluorescence mode SPY PHI imager Fluorescence display modes SPY PHI imager Operating Environment Operating temperature 10 to 30 C Relative humidity...

Page 104: ...Aspect ratio 16 9 Physical Dimensions Height 136 mm Width 88 mm Length 122 mm Weight 495 g not including cables Cable length 3 m Environment Operating temperature 10 to 30 C Relative humidity storage...

Page 105: ...rsuant to Laser Notice No 50 dated June 24 2007 Radio frequency emissions Group 1 Class A As per CISPR 11 Harmonic emissions Class A As per IEC 61000 3 2 Table 13 NIR Radiation and Source Characterist...

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Page 107: ...opy of the Program solely for Your own internal business operations solely on the PINPOINT System on which the Program was first installed consistent with the Documentation b to use the Documentation...

Page 108: ...Section 3 3 Novadaq or its authorized supplier may voluntarily and at its sole discretion offer such support to You 4 TERMINATION This Agreement is effective until terminated Novadaq may terminate thi...

Page 109: ...Program is used however you may not otherwise assign sell transfer delegate or dispose of whether voluntarily or involuntarily by operation of law or otherwise this Agreement or any rights or obligati...

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