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MolecuLight i:X User Manual

Imaging device
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Trademarks
MolecuLight
TM
, MolecuLight i:X
TM
, MolecuLight DarkDrape
TM
, MolecuLight Adapter
TM
, Standard Imaging Mode
TM
,
TM
TM
TM
TM
TM
Fluorescence Imaging Mode
, ST-image
, ST-video
, FL-image
, FL-video
are trademarks of MolecuLight, Inc.
Patent Information
The MolecuLight i:X Imaging Device (hereafter referred to as the device, MolecuLight i:X or MolecuLight i:X Imaging Device)
contains patented technology developed by MolecuLight Inc.:
Canadian Patent No. 2,724,973
U.S. Patent No. 12/992,040
Global patents and further U.S. patents are pending.
Publication Information
User Manual, Part Number 1294, Revision 1.1
Contact Information
The MolecuLight i:X and its accessories are designed and manufactured by MolecuLight Inc.
MolecuLight Inc.
425 University Ave., Suite 700
Toronto, Ontario, Canada
M5G 1T6
TM
MolecuLight i:X
User Manual
Telephone: +1-647-362-4684, or 1-877-818-4360 (North America Only)
Fax: 647-362-4730
Email: info@moleculight.com
www.moleculight.com
The European authorized representative for MolecuLight Inc. is Emergo.
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
TM
MolecuLight i:X
User Manual Revision 1.1
Page 2 of 43

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Summary of Contents for MolecuLight i:X

  • Page 1 , FL-video are trademarks of MolecuLight, Inc. Patent Information The MolecuLight i:X Imaging Device (hereafter referred to as the device, MolecuLight i:X or MolecuLight i:X Imaging Device) contains patented technology developed by MolecuLight Inc.: Canadian Patent No. 2,724,973 U.S. Patent No. 12/992,040 Global patents and further U.S.

  • Page 2: Table Of Contents

    2.2 S ......................................7 YMBOLS 9.6.1 Zooming in and out ..................................29 2.2.1 Symbols Used on the MolecuLight i:X Imaging Device Label ......................7 9.6.2 Panning ......................................29 2.2.2 Symbols Used on MolecuLight i:X ..............................8 9.7 D ................................29...

  • Page 3: Introduction

    Warning exposure to magnetic fields, electrostatic discharge and thermal ignition sources during use of the i:X Imaging Device you will find new and helpful information about the bacterial load in and around wounds during the device. clinical examination process, helping you to better manage wound treatment for your patients.

  • Page 4: Acronym Table

    Table 2: MolecuLight i:X symbols Date of manufacture 2.2.3 Symbols Used on MolecuLight i:X Packaging Catalog number The following table lists the symbols and statements used on the MolecuLight i:X packaging label and indicates storage and transportation conditions. Serial number Symbol Source &...

  • Page 5: Symbols Used For Moleculight Darkdrape Label

    Meaning: Do not use if package is damaged MolecuLight i:X has an operational duty cycle of 15 minutes on, 5 minutes off. The implication for this duty cycle is that if the MolecuLight i:X is continuously used in Fluorescence Imaging Mode for 15 minutes, the device will need to be switched...

  • Page 6: Contents

    Table 7: List of recommended MolecuLight i:X accessories and consumables items 1-6 illustrated in Figure 1 and detailed in Table 6 below. These items allow the MolecuLight i:X Imaging Device to be Do not connect the MolecuLight i:X Imaging Device to a power supply using cables that have not Warning used in a patient care setting.

  • Page 7: Moleculight I:x Imaging Device Overview

    8. Display Screen: provides touch functionality and displays images in real-time 9. Home Button: pressing button turns Display Screen ON 10. Port for Charging Display Screen and Data Transfer: to be used with the white connecting cable on the MolecuLight Power Cable, boot should be lifted for access Figure 3: MolecuLight i:X Real-time Imaging 11.

  • Page 8: Intended Use And Indication For Use

    Proteus spp, Klebsiella pneumoniae, Beta-hemolytic streptococci (Group B) and Enterobacter spp during clinical assessment, Figure 4: Schematic rendering of MolecuLight i:X Imaging Device showing 1- System Status LED, 2- Battery Status LED 3- Range Finder treatment, and monitoring of treatment response of wounds.

  • Page 9: Power Button

    MolecuLight i:X is equipped with a pulsed laser-based Range Finder sensor which is used to determine the distance between MolecuLight i:X and the wound. The Range Finder LED indicates to the user when the device is held at the correct...

  • Page 10: Range Finder Led

    If you are unable to obtain optimal ambient light for Fluorescence Imaging Mode, MolecuLight recommends using When the MolecuLight i:X Imaging Device is OFF, the Battery Status LED is OFF, except when the battery is critically low and MolecuLight DarkDrape (used in conjunction with MolecuLight Adapter). For more information refer to Section 4.3.

  • Page 11: Rocker Switch

    9.3 Imaging with MolecuLight i i :X (iX Camera App) The MolecuLight iX Camera App is a simple and intuitive application that allows you to quickly and easily capture images and videos on your MolecuLight i:X Imaging Device. Warning Only use the iX Camera App to capture wound images and/or videos.

  • Page 12: Capture An Image

    9.3.1.3 6. Aim MolecuLight i:X towards the wound. A square briefly appears in the center of the field of view to indicate The iX Camera App allows you to capture both an ST-video and FL-video by selecting the Video icon.

  • Page 13: Creating A New Album

    To enable the Album feature, open the Settings Menu and tap the Album Feature switch: When the Album feature is enabled, the default Active Album to view saved images/videos on the MolecuLight i:X is the Camera Roll as depicted in Figure 12.

  • Page 14: Accessing And Using Previously Created Albums

    Album. If user chooses not to delete the images after the Album is deleted, the images will be found in the Camera Roll. Figure 17: Deleting Albums MolecuLight i:X User Manual Revision 1.1 Page 27 of 43 MolecuLight i:X User Manual Revision 1.1...

  • Page 15: Z Ooming In And Out And P Anning

    If the USB connector end of the white connecting cable is connected to the USB power adapter, Note disconnect it. 2. Do not use iTunes to copy or move images from MolecuLight i:X to your computer. If you have iTunes on your computer, you will automatically be prompted to access the images/videos via iTunes. MolecuLight i:X User Manual Revision 1.1...

  • Page 16: Home Button

    To prevent unauthorized access to data acquired on the MolecuLight i:X you may want to create a passcode. You are able to lock the Display Screen while not using the MolecuLight i:X. Locking the Display Screen saves battery life and To create a passcode for MolecuLight i:X, go to Settings >...

  • Page 17: Measuring Wound Area

    The 3 available settings are placement is at the 1 and 7 o’clock position or at the 11 and 5 o’clock position when holding the MolecuLight i:X in a portrait (vertical) orientation, as depicted in Figure 22 and Figure 23.

  • Page 18: Auto Mode

    For optimal results, ensure the MolecuLight WoundSticker placement is at the 1 and 7 o’clock position or at the 11 and 5 o’clock position when holding the MolecuLight i:X in a portrait (vertical) orientation, as depicted in Figure 22 and Figure 23.

  • Page 19: Disposal Of Moleculight I:x

    Use a disinfecting wipe (CaviWipe) to remove all debris from the MolecuLight Adapter by gently wiping all sides and Clean and disinfect MolecuLight i:X before and after it is used and between wound assessment procedures. Failure to do so surfaces, including tabs.
  • Page 20 The MolecuLight i:X can be wiped clean using disinfecting wipes. Ensure excess fluid from the wipes does not Make sure all lighting is off in order for the LED to turn green. If you have any questions, contact MolecuLight at enter any openings and that the device is thoroughly dry before use.

  • Page 21: Warranty

    Camera App Error Description Cause Action MolecuLight warrants this product to be free from any defects in material and workmanship for a period of one year from Message the date of purchase by the initial purchaser. Message from iOS to “iX Camera”...

  • Page 22: Appendix A: Specifications

    Height 21 cm Width (maximum) 9.5 cm Depth (maximum) 4 cm Weight 398 g The electrical specifications for the MolecuLight Power Cable P/N 1142 are as follows: Model: PSA05F-050QAL6 Input Output 100-240 V 0.18 A 60 Hz Model: PSA10F-050 Input...
  • Page 23 Display Screen: provides touch functionality and displays images/videos Home Button: turns Display Screen ON Port for charging Display Screen and downloading data: to be used with MolecuLight i:X Connecting Cable Rocker Switch in Standard Imaging Mode™ position: allows for Standard Mode Imaging Rocker Switch in Fluorescence Imaging Mode™...
  • Page 24 6. TURNING OFF b. Turn Display Screen off by a. Turn device off by pressing ©2017 MolecuLight Inc. All Rights Reserved. PN 1295 Rev 1.0. power button for 3 seconds. pressing screen power button Consult the MolecuLight i:X™ User Manual for more information.
  • Page 25 APPENDIX D: INSTRUCTIONS FOR USE Adapter For optimal imaging with the MolecuLight i: X™ Imaging Device in Fluorescence Imaging Mode™ kDrape 10 Pack x(10pk) x (PPI) 1. Use a disinfecting wipe to clean 2. Expand the MolecuLight 3. Carefully place the MolecuLight uary 2016 the MolecuLight Adapter.
  • Page 26 Active Album ICON LEGEND iX Camera App Camera Settings Image Library Auto Trace Manual Trace Expand Contract Checkmark ©2017 MolecuLight Inc. All Rights Reserved. PN 1317 Rev 1.0. Consult the MolecuLight i:X™ User Manual for more information.