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Quest Engineering SPECTRUM 3 Instructions For Use Manual

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QUEST SPECTRUM
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Instructions for Use

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Summary of Contents for Quest Engineering SPECTRUM 3

  • Page 1 ® QUEST SPECTRUM Instructions for Use...
  • Page 2 ® QUEST SPECTRUM Document Change History Summary of Change Document Date Performed Description of Change Version number Version dd/mm/yyyy First issue, based on QMI0009 Version_16. NDK/DBO/ QUEST SPECTRUM-IFU 1.0-1.4 2042 10/06/2020 Several Draft versions made during development of ECO 2042 Lay-out and product information updated as part 2325...
  • Page 3 ® QUEST SPECTRUM ® QUEST SPECTRUM Intra-operative Fluorescence Imaging Open and Minimal Invasive Surgery Instructions for Use...
  • Page 4 ® QUEST SPECTRUM p. 1/50 Corporate Headquarters Quest Medical Imaging B.V. Industrieweg 41 1775 PW Middenmeer The Netherlands Website: www.quest-mi.com Customer Service and Technical Support Email: info@quest-mi.com Phone: +31-227-60-40-46 Fax: +31-227-60-41-85 Contact USA Quest Medical Imaging Inc. 10000 Cedar Avenue Suite 3-164 Cleveland, OH 44106 U.S.A.

  • Page 5: Table Of Contents

    ® QUEST SPECTRUM p. 2/50 Table of Contents Health and Safety Compliance ..................... 4 Important Information ..........................4 Indication for Use ..........................4 User Qualifications ..........................4 Repair and Modification ........................5 System Overview ........................... 6 Components ............................6 Imaging Agent ............................6 Article List .............................7 General System Safety ........................
  • Page 6 ® QUEST SPECTRUM p. 3/50 Starting surgery ..........................22 Case View ............................29 Using the Camera ..........................30 Using the Camera Arm ........................31 Pin code ............................. 33 Case manager ........................... 33 8.10 Settings .............................. 34 8.11 Help ..............................37 Cleaning, Disinfection and Sterilization ..................

  • Page 7: Health And Safety Compliance

    ® QUEST SPECTRUM p. 4/50 1 Health and Safety Compliance 1.1 Important Information WARNING: Read Before Use ® This instruction manual contains essential information on using the QUEST SPECTRUM safely and effectively. Before use, thoroughly review this manual and use the system as instructed. Keep this manual in a safe, accessible location.

  • Page 8: Repair And Modification

    ® QUEST SPECTRUM p. 5/50 1.4 Repair and Modification ® WARNING: The QUEST SPECTRUM 3 does not contain any user-serviceable parts. Annual preventive inspection or maintenance is required. Do not disassemble, modify, or attempt to repair it. Patient or user injury and/or instrument damage can result.

  • Page 9: System Overview

    ® QUEST SPECTRUM p. 6/50 2 System Overview 2.1 Components ® The QUEST SPECTRUM 3 is a Fluorescent Imaging System designed and developed to assist in open and minimally invasive fluorescence image-guided surgery and consists of the following components shown in Figure 1. Figure 1: Overview of the QUEST SPECTRUM®...

  • Page 10: Article List

    ® QUEST SPECTRUM p. 7/50 2.3 Article List Table 1: Overview of all articles sold with the QUEST SPECTRUM® 3. Laparoscopes have a separate manual, Drapes have a separate manual, USA only. Article Number Item Name System ® ART-SYS-0029 QUEST SPECTRUM 3 for VIS/ICG/MB 115V ®...

  • Page 11: General System Safety

    ® QUEST SPECTRUM p. 8/50 3 General System Safety 3.1 Electrical Safety – General WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth. WARNING: Do not use the system adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe to verify normal operation in the configuration in which it will be used.

  • Page 12: Light Safety

    ® QUEST SPECTRUM p. 9/50 3.4 Light Safety WARNING: Do not detach the optical fiber from the ring light or laparoscope when the excitation light source is enabled. Without qualified optical components ring light or laparoscope, the excitation light source must be considered class 3R and corresponding precautions must be taken.
  • Page 13 ® QUEST SPECTRUM p. 10/50 never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire. Always place the light source in standby mode whenever the scope is removed from the light cable, or the device is unattended.

  • Page 14: Icg Safety

    ® QUEST SPECTRUM p. 11/50 4 ICG Safety 4.1 Clinical Pharmacology Following intravenous injection, Indocyanine Green (ICG) is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). ICG undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebral-spinal uptake of the dye.

  • Page 15: Adverse Reactions

    ® QUEST SPECTRUM p. 12/50 4.3 Adverse reactions Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treatment with the appropriate agents (e.g., epinephrine, antihistamines, and corticosteroids) should be administered. 4.4 Over dosage There are no data available describing the signs, symptoms, or laboratory findings accompanying over dosage.

  • Page 16: Symbols And Indicator Lights

    ® QUEST SPECTRUM p. 13/50 5 Symbols and indicator Lights Table 2: General Symbols and Signs Article number Serial number Applied part Class 1 BF type Manufacturer Follow instructions for use Table 3: Symbols and Signs IPC On/ off button with blue light indicator Table 4: Symbols and Signs Trolley Aperture Warning: Do not view the beam with magnifying optical...

  • Page 17: Disposal

    ® QUEST SPECTRUM p. 14/50 6 Disposal The QUEST SPECTRUM ® components and consumables should be disposed of in compliance with local, regional, and national regulations. ❖ Single use or consumable components and accessories such as the QUEST SPECTRUM ® Drapes should be disposed in compliance with the regulatory regulations.

  • Page 18: Unpacking And Setting Up

    ® QUEST SPECTRUM p. 15/50 7 Unpacking and Setting Up 7.1 Unpacking the System WARNING: Check according to Table 5 below if all components are complete and ® undamaged before proceeding installing the QUEST SPECTRUM Contact Quest Medical Imaging B.V. or representative if components are missing or damaged.
  • Page 19 ® QUEST SPECTRUM p. 16/50 ® QUEST SPECTRUM Trolley Barco Branded 4K UHD surgical display Instructions for Use...
  • Page 20 ® QUEST SPECTRUM p. 17/50 Instructions for Use Draping Instructions Quick Start Instructions for Use...

  • Page 21: Setting Up Quest Spectrum ® 3

    ® QUEST SPECTRUM p. 18/50 ® 7.2 Setting Up QUEST SPECTRUM 7.2.1 Installation of components Quest Medical Imaging or a qualified representative will install the components. CAUTION: Installation by personnel that is not qualified by Quest Medical Imaging can result in damage or failure of the device. Quest Medical Imaging is not liable for damage caused by installation by unqualified personnel.

  • Page 22: Camera And Light Connector

    ® QUEST SPECTRUM p. 19/50 7.2.3 Camera and Light Connector In Figure 3, the Camera and Light connection are shown. The camera adapter has a magnetic lock mechanism that eases the connection. The Ring light or the Laparoscope adapter can be connected to ®...
  • Page 23 ® QUEST SPECTRUM p. 20/50 Assembly: 1) Unlock the camera by turning the lens adapter clockwise (from the user’s perspective) 2) Insert the ring light/ laparoscope into the camera 3) Make sure the lens adapter is back in the locked position: a.

  • Page 24: Operation

    ® QUEST SPECTRUM p. 21/50 8 Operation ® 8.1 Preparing the QUEST SPECTRUM ® Take the following into consideration before moving the QUEST SPECTRUM 1. If the Trolley is equipped with an arm onto which the camera or a monitor is mounted, the arm should be folded away before the Trolley is moved.

  • Page 25: Brake Instructions

    ® QUEST SPECTRUM p. 22/50 ® WARNING: The QUEST SPECTRUM Laparoscopes needs to be sterilized prior usage. The sterilization procedures are explained in its own manual. 8.2 Brake instructions ® The QUEST SPECTRUM 3 can be put on the brakes by using the buttons on the side of the trolley. Figure 5: Brake control centre CAUTION: Before lowering the brakes, make sure no cables or other objects are...
  • Page 26 ® QUEST SPECTRUM p. 23/50 Figure 6: home screen Figure 7: insert patient data Instructions for Use...
  • Page 27 ® QUEST SPECTRUM p. 24/50 Figure 8: Start Surgery Figure 9: Select surgery Instructions for Use...
  • Page 28 ® QUEST SPECTRUM p. 25/50 Focus The camera can be focused manually by using the following options: • By using the camera (see chapter 8.2 “using the camera”) • By using the touchpad of the IPC When focusing, the icon will be set to MF (Manual Focus), when done this will be set to the other icon.
  • Page 29 ® QUEST SPECTRUM p. 26/50 180° turn When wanting to rotate the image a complete 180° this function can be used. The whole image will rotate 180° by simply selecting the icon on the side. The icon will also automatically transform into an 180° icon. By selecting the 180°...
  • Page 30 ® QUEST SPECTRUM p. 27/50 Second menu When selecting this icon, another menu will appear. With these extra settings the imaging can be perfected to create the best possible image. Further explanation about these options and possibilities can be found below.
  • Page 31 ® QUEST SPECTRUM p. 28/50 Visible light The amount of visible light can be adjusted by use of these icons. Increasing the amount of visible light has no influence on the fluorescence. Furthermore, increasing or decreasing the light is advised depending on the situation and personal preferences of the user.

  • Page 32: Case View

    ® QUEST SPECTRUM p. 29/50 Figure 10: Surgery mode view (ICG). Main image corresponds to Overlay (OV) mode. On the left, from top to bottom: RGB, NIR, GR modes. 8.5 Case View After having ended the surgery the Case view screen will turn up (see figure 11). In this screen an overview is given of all taken snapshots and recordings.

  • Page 33: Using The Camera

    ® QUEST SPECTRUM p. 30/50 8.6 Using the Camera Figure 12: camera The tables below give an overview of all the options and functions of the camera. There are two different tables, the first one showcases all the options and functions when the menu is closed, and the second table shows the various camera options when the menu is open.

  • Page 34: Using The Camera Arm

    ® QUEST SPECTRUM p. 31/50 Menu Open Long press start video/end video start video/end video Short press snapshot snapshot Turn Manual Focus on Turn manual focus off Scrolling through menu Manual focusing Long press Closes menu Closes menu Short press Selecting an icon Selecting an icon For an open surgery, the camera can be handheld or held by the mechanical camera arm included.
  • Page 35 ® QUEST SPECTRUM p. 32/50 along the joints of the arm (Figure 15). Cables should not be tight between joints, to avoid any damage due to pulling. Figure 14: Camera positioned in arm gripper Figure 15: Cables secured in camera arm ®...

  • Page 36: Pin Code

    ® QUEST SPECTRUM p. 33/50 8.8 Pin code Figure 16: Pin code Each surgeon is given a personal four-digit pin code. This pin code is requested when wanting to access the “case manager” and the “settings”. First, the correct surgeon needs to be selected. Thereafter, the surgeon’s correct pin code needs to be entered (see figure 16).

  • Page 37: Settings

    ® QUEST SPECTRUM p. 34/50 Figure 17: Case manager Delete By selecting this icon, recordings and snapshots can be deleted. Export When wanting to export a recording or snapshot, this icon should be selected. After having selected this icon, the correct device needs to be selected and all content can be exported to this device.
  • Page 38 ® QUEST SPECTRUM p. 35/50 Figure 18: Settings Technical service settings When having entered the correct pin-code after selecting the option Technical service, an interface as shown in figure 19 will appear. See an explanation about the setting options below. Figure 19: Technical service settings Instructions for Use...
  • Page 39 ® QUEST SPECTRUM p. 36/50 By selecting this icon, the recording time and the frame rate during recording can be changed to the user’s preferences. The language and pin code settings can be changed by selecting this icon. When wanting an overview of all registered surgeons this icon should be selected.

  • Page 40: Help

    ® QUEST SPECTRUM p. 37/50 The language and pin code settings can be changed by selecting this icon. 8.11 Help The “help” icon on the home page can be selected when experiencing trouble with the system (see figure 21). Advised is first to try and solve the problem by using the appendix trouble shooting (see appendix A: trouble Shooting).

  • Page 41: Cleaning, Disinfection And Sterilization

    ® QUEST SPECTRUM p. 38/50 9 Cleaning, Disinfection and Sterilization 9.1 Cleaning Instructions Cleaning: ❖ Make sure to unplug the main power supply before cleaning ❖ Use a slightly moistened lint free soft cloth material. Do not soak in cleaning fluids as liquid ingress into unit may result in damage of the electronics.

  • Page 42: Appendix A: Trouble Shooting

    ® QUEST SPECTRUM p. 39/50 10 Appendix A: Trouble Shooting 10.1 Trouble shooting Table 8: Trouble shoot overview Situation Recommended action Check whether the on/off button lights blue (if not press the on/off button till it turns blue) System does not start after Restart the system after 1 minute pressing the on / off button Try another socket...

  • Page 43: Fuse Replace Procedure

    ® QUEST SPECTRUM p. 40/50 10.2 Fuse Replace Procedure Note: If a fuse needed to be replaced make sure that both fuses are replaced at the same time. To replace the fuses, unscrew the fuse holder as shown in Figure 22. The fuses can be found just above the main power supply.

  • Page 44: Appendix B: Technical Specifications

    ® QUEST SPECTRUM p. 41/50 11 Appendix B: Technical Specifications Table 9: Technical specifications Item Value Remark Input voltage 230V AC 115V AC Input frequency 50Hz 60Hz Power dissipation 520 W 520 W Current consumption 2.2A 4.4A Fuse rating 2 x 5A 2 x 8A Ceramic or sand filled (In series)

  • Page 45: Appendix C: Emc And Environmental Safety

    ® QUEST SPECTRUM p. 42/50 12 Appendix C: EMC and Environmental Safety ® The QUEST SPECTRUM 3 has been tested and found to comply with electromagnetic compatibility (EMC) limits for medical devices to IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

  • Page 46: Appendix D: Manufacturer's Declaration

    ® QUEST SPECTRUM p. 43/50 13 Appendix D: Manufacturer’s declaration The system is intended for use in the electromagnetic environment specified in the tables below. For maximum performance, ensure that the system is used in the environments described in these tables. Guidance and Manufacturer’s declaration-electromagnetic emissions Table 11: Guidance and Manufacturer’s declaration-electromagnetic emissions...
  • Page 47 ® QUEST SPECTRUM p. 44/50 Guidance and Manufacturer’s declaration-electromagnetic immunity Table 12: Guidance and Manufacturer’s declaration-electromagnetic immunity ® The QUEST SPECTRUM 3 is intended for use in the electromagnetic environment specified below. The ® customer or the user of the QUEST SPECTRUM 3 should assure that it is used in the following environment: IEC 60601-1-2 Compliance...
  • Page 48 ® QUEST SPECTRUM p. 45/50 Portable and mobile RF communications equipment should ® be used no closer to any part of the QUEST SPECTRUM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 49 ® QUEST SPECTRUM p. 46/50 Guidance and Manufacturer’s declaration-electromagnetic immunity Table 14: Recommended separation distance between portable ® and mobile RF communications equipment and the QUEST SPECTRUM ® The QUEST SPECTRUM 3 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 50 ® QUEST SPECTRUM p. 47/50 Declaration of Conformity Manufacturer: Quest Medical Imaging B.V. Industrieweg 41 1775 PW Middenmeer the Netherlands ® We declare under our sole responsibility that the QUEST SPECTRUM 3 complies with the following directive: Directive 93/42/EEC-M5 for medical devices 2797 ®...

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