MolecuLight i:X Manual Del Usuario página 8

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1. Standard Imaging Mode (or ST-Mode): Real-time imaging as per standard photography.
In Standard Imaging Mode, MolecuLight i:X is able to capture the following images:
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a. ST-image : An image captured in Standard Imaging Mode
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b. ST-video : A video captured in Standard Imaging Mode
Note Wound measurement is only possible on an ST-Image (see Section 10).
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2. Fluorescence Imaging Mode (or FL-Mode): Real-time imaging in Fluorescence Imaging Mode as a result of violet light
illumination. In Fluorescence Imaging Mode, MolecuLight i:X is able to capture the following images:
a. FL-image TM : An image captured in Fluorescence Imaging Mode
b. FL-video TM : A video captured in Fluorescence Imaging Mode
The device provides image-guidance during visual assessment of wounds.
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The device can capture an ST-image
, ST-video
, FL-image
and extent of harmful bacteria. This helps to guide the clinical team towards a more comprehensive wound examination
through guided or 'targeted' debridement and sampling of potentially harmful bacteria. Images can be appended to a
patient's clinical care record by exporting the images in JPEG format or printing them (see Section 9.9).
Figure 2: Clinician side, side views and Patient side of MolecuLight i:X Imaging Device
1. Power Button: pressing button turns the device ON/OFF
2. Display Screen Power Button: pressing button turns Display Screen ON/OFF
3. System Status LED: indicates overall device performance
4. Battery Status LED: indicates device battery charge
5. Range Finder LED: indicates optimal distance from wound
6. Ambient Light Status LED: indicates optimal lighting environment for Fluorescence Imaging Mode
7. Heat Sink: dissipates heat during use
Warning Heat Sink may get warm after prolonged use
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
11. Rocker Switch for Standard Imaging Mode and Fluorescence Imaging Mode: allows the user to switch between
Standard Imaging Mode and Fluorescence Imaging Mode
12. Violet Wavelength LEDs: provide illumination when in Fluorescence Imaging Mode
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MolecuLight i:X User Manual Revision 1.0
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, and FL-video
of wounds to quickly identify the presence
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13. Camera Sensor Window: protects the camera sensor which allows image and video capture
14. Range Finder Sensor: detects optimal distance from wound, and
Ambient Light Sensor: detects optimal lighting conditions for Fluorescence Imaging Mode
15. Illumination Zone: area includes camera sensor window, Violet Wavelength LEDs, Ambient Light Sensor and Range
Finder Sensor
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
Note
window with your fingers
16. Label: lists certifications, references User Manual, indicates date of manufacture, contains MolecuLight Inc.'s address,
provides device model and serial number
17. Holding Contour: allows the user to grip the device securely
18. MolecuLight i:X Charging Port: allows device charging with black power supply cable on the MolecuLight Power Cable
19. Buttons for future functionality
MolecuLight's training program includes the following to ensure user knowledge of how to operate the device:
Reading this User Manual in its entirety
Following the Quick Start Guide (Appendix C) and the MolecuLight i:X Imaging Device Overview (Appendix B)
Following the MolecuLight DarkDrape & MolecuLight Adapter Instructions for Use (Appendix D) and the MolecuLight i:X
Wound Measurement Quick Start Guide (Appendix E)
The MolecuLight i:X Imaging Device is restricted to use by trained health care professionals and
Caution
should be protected from unauthorized use.
4.2 How MolecuLight i i :X Creates Images in FL-Mode
The MolecuLight i:X includes two high-efficiency violet wavelength emitting LEDs that illuminate wounds and surrounding
skin for high-resolution and real-time fluorescence imaging of bacteria and tissues, without the need for contrast agents.
When wounds are illuminated by violet light, endogenous collagens in the connective tissue matrix emit a green colored
fluorescent signal. Some bacteria emit a red colored fluorescence signal due to the production of endogenous porphyrins,
and others emit a cyan colored fluorescence signal due to the production of endogenous pyoverdine. The MolecuLight i:X
Imaging Device simultaneously captures fluorescence from both bacteria and tissues and creates a composite image on the
high-resolution color LCD Display Screen. The user can easily and instantly visualize the presence and location of bacteria
within and around a wound.
Figure 3 illustrates how MolecuLight i:X uses violet light illumination to create real-time fluorescence images.
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
Caution
window with your fingers, as this may affect illumination and image quality (see Figure 2, item 15).
Note The red color may appear orange to some users.
Figure 3: MolecuLight i:X Real-time Imaging
Violet Wavelength LEDs homogeneously illuminate the wound, resulting in the generation of a red or cyan fluorescence
signal when bacteria are present due to the presence of endogenous porphyrins or pyoverdine.
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