User's Manual

DD399 MolecuLight DX® User Manual for Wi-Fi Certification
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Introduction
The MolecuLightDX is a cordless, handheld device indicated for standard digital imaging and fluorescence imaging.
The MolecuLightDX’s standard digital imaging capability can acquire and document standard digital images of
dermatological wounds, and aid clinicians in measuring their surface area, length, and width.
The MolecuLightDX’s fluorescence digital imaging capability can acquire (in real-time) and document intrinsic
fluorescence emission of dermatological wounds between 500-545 nm and 600-665 nm when illuminated by violet
405 nm excitation light under acceptable environmental lighting conditions.
The MolecuLightDX is capable of capturing high-resolution still images and/or video using the standard digital
imaging and fluorescence digital imaging.
MolecuLight Inc. provides technical support, a User Manual, and Quick Start Guides to aid you with the use of the
MolecuLightDX. Please review this User Manual thoroughly before operating your device.
Indications for Use
The MolecuLightDX is intended for use as a handheld imaging tool that allows clinicians diagnosing and treating
skin wounds, at the point of care, to
(i) View and digitally record images of a wound,
(ii) Measure and digitally record the size of a wound, and
(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation
light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase
the likelihood that clinicians can identify wounds containing bacterial loads >10
4
CFU per gram as compared to
examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the
presence of bacteria in a wound.
The MolecuLightDX does not diagnose or treat skin wounds.
Caution
Do not use the MolecuLightDX for purposes other than imaging or video
documentation of wounds using the iX Imaging App. Do not use any other
Apps which may be present on the MolecuLightDX.
Warnings, Cautions, and Notes
Please read the following safety information before using the MolecuLightDX Imaging Device.
The MolecuLightDX is an imaging device that does not require contact with the patient. It captures images/videos
and utilizes safe levels of violet wavelength light to illuminate a wound for fluorescence imaging. The
MolecuLightDX Imaging Device does not require the use of exogenous imaging contrast agents. Some patients may
experience some warmth from the device during exposure.
The Range Finder Sensor contains a fully-enclosed laser. No hazardous laser radiation is emitted during use. No eye
or skin protection is required for the user or patient when operating the MolecuLightDX.