Operators Manual
110 Pages
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Customer Support 800 624 4422 Toll Free (USA only) 408 754 2039 800 729 2917 Toll Free (USA only) Fax 408 754 2969 Fax Email: [email protected] Novadaq Technologies ULC 8329 Eastlake Drive, Unit 101 Burnaby, BC V5A 4W2 Canada
Document: 4-0003045 Edition: English – INTL Revision: Rev.G, 2021-04 Printed in Canada
© 2021 by NOVADAQ Technologies ULC U.S. Patents: www.stryker.com/patents Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: NOVADAQ, PINPOINT, SPY-PHI, STRYKER. All other trademarks are trademarks of their respective owners or holders. The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo. Copyright © 2006 by Tavmjong Bah. All Rights Reserved. Permission is hereby granted, free of charge, to any person obtaining a copy of the fonts accompanying this license ("Fonts") and associated documentation files (the "Font Software"), to reproduce and distribute the modifications to the Bitstream Vera Font Software, including without limitation the rights to use, copy, merge, publish, distribute, and/or sell copies of the Font Software, and to permit persons to whom the Font Software is furnished to do so, subject to the following conditions: The above copyright and trademark notices and this permission notice shall be included in all copies of one or more of the Font Software typefaces. The Font Software may be modified, altered, or added to, and in particular the designs of glyphs or characters in the Fonts may be modified and additional glyphs or characters may be added to the Fonts, only if the fonts are renamed to names not containing either the words "Tavmjong Bah" or the word "Arev". This License becomes null and void to the extent applicable to Fonts or Font Software that has been modified and is distributed under the "Tavmjong Bah Arev" names. The Font Software may be sold as part of a larger software package but no copy of one or more of the Font Software typefaces may be sold by itself. THE FONT SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL TAVMJONG BAH BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, INCLUDING ANY GENERAL, SPECIAL, INDIRECT, 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. Except as contained in this notice, the name of Tavmjong Bah shall not be used in advertising or otherwise to promote the sale, use or other dealings in this Font Software without prior written authorization from Tavmjong Bah. For further information, contact: [email protected].
Permission is hereby granted, free of charge, to any person obtaining a copy of the fonts accompanying this license ("Fonts") and associated documentation files (the "Font Software"), to reproduce and distribute the Font Software, including without limitation the rights to use, copy, merge, publish, distribute, and/or sell copies of the Font Software, and to permit persons to whom the Font Software is furnished to do so, subject to the following conditions: The above copyright and trademark notices and this permission notice shall be included in all copies of one or more of the Font Software typefaces. The Font Software may be modified, altered, or added to, and in particular the designs of glyphs or characters in the Fonts may be modified and additional glyphs or characters may be added to the Fonts, only if the fonts are renamed to names not containing either the words "Bitstream" or the word "Vera". This License becomes null and void to the extent applicable to Fonts or Font Software that has been modified and is distributed under the "Bitstream Vera" names. The Font Software may be sold as part of a larger software package but no copy of one or more of the Font Software typefaces may be sold by itself. THE FONT SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL BITSTREAM OR THE GNOME FOUNDATION BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, INCLUDING ANY GENERAL, SPECIAL, INDIRECT, 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. Except as contained in this notice, the names of Gnome, the Gnome Foundation, and Bitstream Inc., shall not be used in advertising or otherwise to promote the sale, use or other dealings in
this Font Software without prior written authorization from the Gnome Foundation or Bitstream Inc., respectively. For further information, contact: [email protected]
Copyright © 2003 by Bitstream, Inc. All Rights Reserved. Bitstream Vera is a trademark of Bitstream, Inc.
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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 ...6 Warning Labels on the SPY Portable Handheld Imaging System ...7 Electromagnetic Compatibility (EMC) and Environmental Safety ...7 Damaged or Malfunctioning Equipment ...8 Cleaning and Disinfecting ...8
Repair and Modification ... 9 Disposal of SPY-PHI System Components ... 9 Symbols and Indicator Lights ... 10 Indicator Lights on the Video Processor / Illuminator (VPI) ... 15
Chapter 2
Unpacking and 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 Video Processor / Illuminator (VPI) ... 20 Connecting to an Medical-grade Video Monitor... 21 Connecting to a Medical Recorder ... 22 Connecting to Ancillary Video Devices (Optional) ... 22 Selecting the Appropriate Video Output Format ... 22 Connecting the SPY-PHI Imager to the VPI ... 23
Chapter 3
Handling, Preparation, and Administration of ICG ...25
About Indocyanine Green (ICG) Imaging Agent ... 25 ICG Safety ... 25 Clinical Pharmacology ... 25 ICG Contraindications ... 25 ICG Warnings ... 26 ICG Adverse Reactions ... 27
General ICG Preparation Instructions ... 27 ICG Administration via Central or Peripheral Venous Line ... 28 Supplies Required for each Imaging Sequence ... 28 Dosage ... 28 Preparation for ICG Administration ... 29 SPY Portable Handheld Imaging System Operator’s Manual
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ICG Administration ... 29 Timing of ICG Administration... 29
Disposal of Consumables and ICG ... 29
Chapter 4
Draping the SPY-PHI Imager ...31
Fitting the Drape ... 32 Removing the Drape ... 38 Disposal of Consumables ... 38
Chapter 5
Overview of SPY-PHI Components ...39
SPY-PHI Imager Controls, Indicators, and Labels ... 39 VPI Controls, Indicators, and Labels ... 42
Chapter 6
Operating the SPY-PHI System ...43
Powering on the System into Standby Mode ... 44 Focusing the Image using the SPY-PHI Controls ... 45 Turning On Fluorescence Imaging Mode ... 47 Display Modes in Fluorescence Imaging Mode ... 49 Overlay Mode ... 49 SPY Color-Segmented Fluorescence (CSF) Mode ... 50 SPY Mode ... 50 Selecting Fluorescence Display Modes ... 51
Toggling between Fluorescence and White-light 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 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 ... 63 Capturing Screenshots on the Stryker SDC3™ HD Information Management System ... 63 Capturing Screenshots on Sony 1000MD and Sony 3300MT Recorders ... 65 Capturing Screenshots on TEAC UR-4MD Recorders ... 66
Performing a White Balance ... 67 Using the VPI Options Menu ... 70 Accessing the VPI Options Menu from the SPY-PHI imager ... 71 Navigating the VPI Options Menu ... 72 Accessing and Navigating the VPI Options Menu from the VPI ... 72 Image Quality Settings ... 74 Display Options Settings ... 75 User Profiles ... 75 ii
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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 ... 81 SPY-PHI Imager Communication Error ... 81 Illumination Error ... 82 Video Recording 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 Replacement Procedure ... 92
Appendix B: VPI Menu Options and Settings ...93 Image Quality Menu Settings ... 93 Sharpening (0-10) ... 93 Brightness (0-255) ... 93 Red Saturation (0-1024) ... 93 Blue Saturation (0-1024) ... 93 Peak/Mean ... 93
Default Profile Menu ... 94 Service Menu ... 95 Display Options Menu ... 95 SPY Image ... 95 Overlay Image ... 95 SPY Color Segmented Fluorescence (CSF) Image ... 95
Appendix C: Specifications and Standards ...97 Appendix D: Software License Agreement ...101
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WARNING:
Read before use. This Operator’s Manual contains essential information on using the SPY Portable Handheld Imaging System (SPY-PHI System) safely and effectively. Before use, thoroughly review this manual and use the system as instructed. 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. 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.
Note: Provides special information to clarify instructions or present additional useful information.
The SPY Portable Handheld Imaging System (SPY-PHI System) is an active device used to visualize circulation, including lymphatics and blood vessels, as well as related tissue perfusion with near infrared fluorescence imaging during a variety of surgical procedures. The SPY Portable Handheld Imaging System is to be used by trained healthcare professionals and it does not provide diagnosis or prescribe therapy.
WARNING:
The imaging system should be used according to its approved Intended Use.
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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
Figure 1:
SPY-PHI System components
1.
SPY Portable Handheld Imager (SPY-PHI)
4.
Camera cable
2.
Light guide cable
5.
Camera port
3.
Light guide port
6.
Video Processor/Illuminator (VPI)
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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:
WARNING:
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▪
medical-grade video monitor
▪
medical-grade video recorder
▪
articulating arm
▪
medical cart
This manual does not explain or discuss clinical procedures. Therefore, this imaging system must only be used by, or under the supervision of, a licensed physician. The operator must be trained in clinical procedures.
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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. Do not connect or disconnect the SPY-PHI camera cable while the VPI is powered 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 to approved medical systems or to systems that are powered from approved isolation transformers. Do not use the imaging system if the power cord or plug is damaged or modified in any way. Do not remove or override the ground connection on the power cords.
CAUTION:
Unplug power cords by grasping the plug. Do not unplug power cords by pulling on the cable. To isolate the equipment from supply mains, set the mains power switch on the rear panel of the VPI to off.
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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). Figure 2: Laser aperture on the SPY-PHI imager
Note:
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The SPY-PHI System is a laser device. Always comply with local regulations and consult with a local laser safety officer for safe use of laser devices, particularly, when using the SPY-PHI System for imaging a patient's facial area.
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The SPY-PHI imager and system VPI1 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. 1
The Video Processor/Illuminator used with the SPY-PHI imager is a component that is shared with the PINPOINT Endoscopic Fluorescence Imaging System.
The user is expected to follow all precautions and warnings outlined in this manual, and adhere to the electromagnetic compatibility (EMC) limits set out in the electromagnetic compatibility guidance document. Failure to do so may compromise the system’s ability to maintain basic safety under abnormal EMC conditions. The imaging system has been certified for compliance with international standards for EMC and is suitable for use in professional healthcare 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 with other electro-medical equipment. However, there is no guarantee that interference will not occur in any particular installation. If in turning the imaging system off and on, the SPY Portable Handheld Imaging System is shown to cause harmful interference to other electro-medical equipment, the user is encouraged to try to correct the interference by:
WARNING:
▪
Reorienting or relocating the imaging system or the equipment receiving the interference
▪
Increasing the separation between the imaging system and the equipment receiving the interference
▪
Connecting the imaging system to an outlet on a different circuit from the one to which the other equipment is connected
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify normal operation. SPY Portable Handheld Imaging System Operator’s Manual
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WARNING:
Use of accessories, transducers and cables other than those specified or provided by NOVADAQ could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Note:
The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). It is not intended for use in a residential environment (for which CISPR 11 Class B is required). 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. Failure to follow this warning may lead to injury. In the event of a drop or impact, inspect the SPY-PHI imager and do not use it: ➢
If there is any visible damage to the imager
➢
If there is evidence of sharp edges or exposed pinch points
➢
If there is concern that the impact might have damaged the imager
If any of the above events occur, please contact Stryker Customer Support.
WARNING:
Follow the instructions in Chapter 8 to clean and disinfect the SPY-PHI System components and accessories. Keep the light guide cable connector clean at all times. Contaminants on the light guide cable connector may cause overheating.
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WARNING:
The imaging system does not contain any user-serviceable parts and does not require any preventive inspection or maintenance. Do not disassemble, modify or attempt to repair it. Patient or user injury and/or instrument damage can result. Refer all servicing to a qualified NOVADAQ service representative. 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: ➢
Clean and disinfect the component thoroughly prior to returning for repair.
➢
Ideally, return the component in its original packaging. If this is not possible, package the part sufficiently to secure it for transport. NOVADAQ is not liable for damage resulting from improper shipping.
The SPY-PHI System components should be disposed of in compliance with local, regional, and national regulations, or returned to NOVADAQ for disposal.
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The following section describes symbols and indicators that appear on the SPYPHI imager and VPI. Table 2: Symbols on the SPY-PHI Imager
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Turn laser on/off (green button)
Button pad
A
Display Mode (grey button)
Button pad
B
Tools menu button (grey button)
Button pad
Focus (upper blue button)
Button 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 temperature: +30°C
Device ID label, bottom of imager
Refer to instruction manual/booklet
Device ID label, bottom of imager
Reference or Model name/number
Device ID label, bottom of imager
Serial number
Device ID label, bottom of imager
CE Marking declaring EU Directive compliance
Device ID label, bottom of imager
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Table 3: Symbols on the Video Processor / Illuminator (VPI) and on System Labeling
Power On
Rear panel, power switch
Power Off
Rear panel, power switch
Stand-by mode
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 menu feature)
Front panel
Right (part of menu feature)
Front panel
Camera socket
Front panel
Refer to instruction manual/booklet
Rear panel
Caution
Rear panel
or
*applicable to PINPOINT camera and NOVADAQ laparoscope
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General Warning
Accompanying Documentation
Laser Warning
Front panel
Manufacturer
Rear panel
Date of manufacture
Rear panel
Reference or Model name/number
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
Made in Taiwan
Accessory Packaging
Do not reuse - single use only
Accessory Packaging
Use-by Date
Accessory Packaging
Fuse
Rear panel
Do not dispose in general waste
Rear panel
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Equipotential symbol
Rear panel
SGS Q-mark
Rear panel
CE Marking declaring EU Directive compliance
Rear panel
Authorized 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 Chapter 6
Illumination failed error
Appendix A
Overlay display mode
See Chapter 6
SPY display mode
See Chapter 6
CSF display mode
See Chapter 6
White balance in progress
See Chapter 7
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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 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 rotated 1800
See Chapter 7
SPY-PHI imager error
See Appendix A
Language setting
See Chapter 7
Button action- Focus adjustment
See Chapter 6
Button action- Focus limit reached
See Chapter 6
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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 – Screenshot device unavailable
See Chapter 7
Tools menu – White balance
See Chapter 7
Tools menu – VPI Options menu
See Chapter 7
Table 5: Indicator Lights on the VPI
Laser indicator1
Top left side of front panel
Power indicator
Above “Power” button
Illumination indicator
Blue
Laser on
Amber
Off
Green
On
Above “Illumination” button
White
Illumination on
Below “Illumination” button
Green
Down
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