Manual Mode - MolecuLight i:X Manual Del Usuario

Once the user has pressed the Contract
Note
range, the Contract icon will disappear, leaving the Expand
Note
The wound area measurement is not displayed unless the user selects the Checkmark

10.3 Manual Mode

If Auto Mode is not tracing an accurate wound boundary, the iX Camera App also allows for manual tracing of the wound
border to measure wound area. The following steps are required for manual wound area measurements:
1. Ensure the Standard Imaging Mode wound image is captured with 2 MolecuLight WoundStickers (P/N 1266) placed
close to and within the plane of the wound. Measurement accuracy will be degraded if the MolecuLight WoundStickers
are off plane, in which case stickers may appear elliptical. 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.
2. When capturing an image, ensure the MolecuLight i:X Camera Sensor is parallel to the wound and the MolecuLight
WoundStickers are in field of view.
3. Open the image of interest from the Image Library
4. Use your index finger or a stylus to draw the border of the wound. Maintain contact with the Display Screen until
closing the wound border trace.
5. Select the Checkmark icon if the trace is acceptable.
6. If the trace is not acceptable, press the Manual Trace
Manual Mode.
7. Once the desired wound border is drawn, a Checkmark
2
the wound area will appear in cm .
Note The wound area measurement is not displayed unless the user selects the Checkmark icon.
10.3 Saving a Wound Measurement
When a wound border is traced (in either Auto or Manual Mode), a Checkmark
pop-up message will appear prompting the user to 'Accept and Save' the image. The user should select 'OK' when the
wound border trace accurately represents the border of the wound. Once 'OK' is selected, the image with the wound
border, reported area measurement, and any length/width or vertical/horizontal dimensions (when enabled) will be saved
as a new image to the same Album as the original image.
11 Interpretation of Fluorescence Images
MolecuLight i:X allows real-time visualization of the presence and distribution of bacteria in wounds (for more details, see
Sections 4.2 and 5). When the device is used in FL-Mode as described in Step 5 of the Quick Start Guide in Appendix C,
fluorescence images of a wound may be obtained.
The fluorescence images obtained with the MolecuLight i:X Imaging Device have distinct fluorescence colors which are
associated with bacteria and other different wound components. Users may see the following characteristic fluorescence
colors when imaging wounds:
Color
Red* Typically associated with the presence of potentially harmful levels of bacteria
Green Typically associated with connective tissues in skin
Typically associated with blood, highly vascularized tissues, necrotic tissue, highly pigmented tissue
Dark/black areas
(freckles, moles, etc.) or poorly illuminated areas
Typically associated with materials in the field of view that are white (bed sheet, clothing, paper,
White
wound measuring ruler, etc.) or oversaturation of color signal
Cyan Typically associated with the presence of Pseudomonas aeruginosa
Table 13: Color indicators for interpretation of fluorescence images
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MolecuLight i:X User Manual Revision 1.0
icon until it reaches the smallest detection threshold
icon.
icon.
. Select the Manual Trace icon.
icon once to exit Manual Mode and press it again to reenter
icon is available to 'Accept and Save' the wound border and
icon is available and when selected, a
Indicator
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Note* Red color of bacteria may appear orange to some users.
Figure 24 provides examples of the Standard Imaging Mode (ST-Image) and corresponding Fluorescence Imaging Mode (FL-
Image) from typical diabetic foot ulcers (DFUs) showing the characteristic red and green fluorescence colors typically seen
during use of the MolecuLight i:X Imaging Device for assessing a DFU.
11.1 Color Blindness
Correct interpretation of the images acquired with the MolecuLight i:X Imaging Device requires that the user can
differentiate between green and red colors. A typical test for red-green color blindness involves looking at color swatches
(see the examples in Figure 25). Individuals who do not suffer from red-green color blindness will be able to see the number
56 in the left-hand color swatch shown below, and the number 74 in the right-hand color swatch shown below.
Figure 25: Color figure swatches used in a typical clinical color-blindness test
Caution MolecuLight i:X should not be used by individuals confirmed to be color blind.
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Figure 24: Examples of MolecuLight i:X images in Standard
Imaging Mode and Fluorescence Imaging Mode. Red color
indicates the presence of bacteria (shown by arrows).
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