Power Button - MolecuLight i:X Manual Del Usuario

4.3 MolecuLight DarkDrape and MolecuLight Adapter Device Description and Use
Used together, the MolecuLight DarkDrape and the MolecuLight Adapter provide a convenient and optimal environment for
imaging wounds when room lights cannot be turned off or windows cannot be blocked.
The MolecuLight DarkDrape provides a light-blocking shield that may be draped over a wound. The MolecuLight Adapter
provides an attachment that allows the MolecuLight i:X to connect to the MolecuLight DarkDrape. After the MolecuLight
DarkDrape is securely attached to the MolecuLight Adapter, the MolecuLight Adapter slides onto the MolecuLight i:X and
clicks into place.
Please see Section 12.4 for MolecuLight Adapter cleaning instructions.
Please see Appendix D for the MolecuLight DarkDrape and MolecuLight Adapter Instructions for Use.
Warning
Do not reuse the MolecuLight DarkDrape. It is for single use only.
Caution Do not overtighten the drawstring when securing the MolecuLight DarkDrape to the patient.
Caution Avoid touching the wound with the MolecuLight DarkDrape.
Be aware of compromised visibility of the imaging target when using the MolecuLight DarkDrape to
Caution
avoid injuring the patient.
Note Ensure the MolecuLight DarkDrape does not obstruct the imaging field of view.
Note The MolecuLight DarkDrape is designed for fluorescence imaging on the lower leg or foot.
5 Intended Use and Indication for Use
The MolecuLight i:X instantly visualizes the presence of potentially harmful levels of bacteria through endogenous
autofluorescence without the need for contrast agents or contact with the patient. The intended use of the device is to
assist health care professionals during the management of patients with wounds by enabling real-time visualization of
potentially harmful bacteria. The device is intended to be used as part of routine clinical wound assessment processes
which may include examination for characteristic signs and symptoms of infection. Under violet light illumination, the
MolecuLight i:X can capture and document images or videos of wounds and surrounding areas where fluorescent bacteria
may be present. The bacterial fluorescence signals detected by the device provide health care professionals with a visual
indication of bacterial presence, load, and location within and around wounds. This information can be used to guide health
care professionals in their selection, application, and response monitoring of wound therapies.
The indication for use of the device is to instantly visualize the presence of potentially harmful bacteria commonly found
within or around wounds including S. aureus, P. aeruginosa, E. coli, Coagulase-negative staphylococci, Enterococcus spp,
Proteus spp, Klebsiella pneumoniae, Beta-hemolytic streptococci (Group B) and Enterobacter spp during clinical assessment,
treatment, and monitoring of treatment response of wounds.
5.1 Off Label Use
The MolecuLight i:X is intended only to be used with the iX Camera App
documentation of wounds. Using the MolecuLight i:X for other purposes, or using Apps other than the iX Camera App which
may be available on the MolecuLight i:X device is considered off label use.
6 Device Basics
The device consists of two primary elements:
1. MolecuLight i:X Imaging Device – contains the electronics required to support its imaging functionality, including optical
filters, camera sensor, range finder and ambient light sensors and the violet light source. It also contains several LEDs to
indicate the status of various operational components of the device.
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The MolecuLight i:X Imaging Device contains a rechargeable battery which needs to be kept charged in order for
MolecuLight i:X to work properly. Refer to Section 9.8 for details about charging the
MolecuLight i:X.
Primary features on the MolecuLight i:X Imaging Device include:
Rocker Switch
Two Power Buttons
Four Status indicator LEDs (see Figure 4)
Two Charging Ports
2. Display Screen – displays both standard light and fluorescence images on a touch-sensitive color LCD screen, which can
be controlled by the user touching the screen in order to control the imaging functionality of the device.
The Display Screen leverages iPod technology and has the following characteristics:
4-inch (diagonal) widescreen display with Multi-Touch technology
1136-by-640-pixel resolution at 326 pixel per inch
800:1 contrast ratio (typical)
2
500 cd/m max brightness (typical)
Fingerprint-resistant oleophobic coating
The Display Screen contains a rechargeable battery, which needs to be kept charged in order for MolecuLight i:X to function
properly. Refer to Section 9.8 for details about charging the Display Screen.
For instructions about using the device's Display Screen functionality, please refer to Section 9.10.
The Display Screen and the MolecuLight i:X Imaging Device each contain separate rechargeable
Note batteries. Both batteries need to be charged separately in order for MolecuLight i:X to work
properly. Refer to Section 9.8 for details about charging the MolecuLight i:X.
Figure 4: Schematic rendering of MolecuLight i:X Imaging Device showing 1- System Status LED, 2- Battery Status LED 3- Range Finder
LED and 4- Ambient Light Status LED

6.1 Power Button

The MolecuLight i:X Imaging Device has a Power Button for controlling the ON/OFF state of the electronics in the device.
The Power Button can toggle the MolecuLight i:X to one of the following states:
OFF: the MolecuLight i:X is powered off
ON: the MolecuLight i:X is powered on (Violet Wavelength LEDs turn on after Fluorescence Imaging Mode is
selected)
The ON/OFF state of the MolecuLight i:X is independent of the ON/OFF/SLEEP state of the Display
Note
Screen. Refer to Section 9.10 for details about the ON/OFF state of the Display Screen.
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