MolecuLight i:X Manual Del Usuario página 4

1 Introduction
Congratulations on your purchase of the MolecuLight i:X
allows you to rapidly visualize potentially harmful bacteria in real-time during wound assessment and includes a wound
measurement application for quick wound area measurements. MolecuLight is confident that as you use the MolecuLight
i:X Imaging Device you will find new and helpful information about the bacterial load in and around wounds during the
clinical examination process, helping you to better manage wound treatment for your patients.
The device is designed to aid and simplify clinical assessment, microbial sampling and treatment of wounds provided by
clinicians at the point-of-care. Its compact, handheld size and intuitive and simple user interface are designed for use across
hospitals and wound care clinical settings.
MolecuLight Inc. provides technical support, a User Manual, a Quick Start Guide and other educational references to aid you
with the use of the MolecuLight i:X Imaging Device. Please review this User Manual thoroughly before operating your
device.
2 Warnings, Cautions, and Notes
Please read the following safety information before using the MolecuLight i:X Imaging Device.
The MolecuLight i:X 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 MolecuLight i:X Imaging
Device does not require the use of exogenous imaging contrast agents.
The MolecuLight i:X is a Class II medical device per Health Canada Regulations.
The MolecuLight i:X is a Class IIa medical device per MDD 93/42/EEC.
MolecuLight i:X is intended for use by trained health care professionals.
There are no known contraindications or side effects associated with the use of the MolecuLight i:X.
Some patients may experience some warmth from the device during exposure.
The Range Finder Sensor (see Figure 2, item 14) 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 MolecuLight i:X.
Refer to Section 2.1.3 for the meaning of acronyms used throughout this User Manual.
2.1 Warnings, Cautions, and Notes
Warnings, cautions, and notes are used to describe serious and non-serious safety conditions of the device. The symbols
used to describe these safety conditions are:
Messages with this heading indicate serious adverse reactions, potential safety hazards, and
Warning limitations in use imposed by a condition labeled with a warning. The warning identifies steps that
should be taken if the incident occurs.
Messages with this heading indicate information regarding any special care to be exercised by the user
Caution and/or patient for the safe and effective use of the device. All caution statements should be followed
to ensure data and device integrity.
Messages with this heading provide additional information that increase the user's understanding of
Note
the operation of the device.
2.1.1 General Warning Messages
The use of an accessory or cable with the MolecuLight i:X Imaging Device other than those specified in
Warning Section 3 may result in increased emissions or decreased immunity of the MolecuLight i:X Imaging
Device.
TM
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Imaging Device. The handheld MolecuLight i:X Imaging Device
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The MolecuLight i:X Imaging Device comes fully assembled and ready for use. No modification of this
Warning
equipment is allowed. Modification of the device will void the terms of the warranty.
Warning Do not stack the MolecuLight i:X Imaging Device.
MolecuLight i:X is intended to be used in a hospital/clinic by trained health care professionals. Avoid
Warning exposure to magnetic fields, electrostatic discharge and thermal ignition sources during use of the
device.
Do not charge or use the device in areas with potentially explosive atmospheres such as fueling areas
Warning
or in areas where the air contains chemicals or particles.
Warning Do not point the violet wavelength LEDs directly into eyes (see Figure 2, item 12).
MolecuLight i:X is not suitable for use in the presence of flammable anesthetic mixtures with air,
Warning
oxygen or nitrous oxide.
Protect MolecuLight i:X against dust and moisture by storing it in its original shipping package
Warning
overnight or when not in use for prolonged periods of time.
Warning Avoid strong physical shocks and dropping.
Any damage to the device (crack or other visible deformity) may affect the functional, intended use
Warning
and/or safety of the MolecuLight i:X. Contact MolecuLight for guidance at [email protected].
Warning Do not soak or immerse MolecuLight i:X in water or other liquids.
Be aware of surroundings when operating MolecuLight i:X in a dark environment. The environment
Warning should be safe to prevent tripping or bumping into any objects during fluorescence imaging
procedures.
2.1.2 General Caution Messages
Caution Do not attempt to use the device while it is charging. The device will not function.
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).
Prior to charging the device, ensure the MolecuLight Power Cable P/N 1142 (described in Section 3.1)
Caution is undamaged before plugging into a wall outlet. Use of an extension cord or an electrical power bar is
discouraged.
When charging is complete, the MolecuLight Power Cable P/N 1142 should initially be disconnected
Caution
from the wall electrical outlet and then removed from the MolecuLight i:X Imaging Device.
Use of controls, adjustments or procedures other than those specified in this User Manual may result
Caution
in hazardous laser light radiation exposure from the Range Finder Sensor (Section 2.5).
The MolecuLight i:X Imaging Device is restricted to use by trained health care professionals and should
Caution
be protected from unauthorized use.
The Heat Sink (Figure 2, item 7) may get warm after prolonged use. The device will shut down if
Caution
0
temperature exceeds 46 C or 115
Caution Improper cleaning/disinfection of the device may result in distorted images.
Caution Images/videos should be regularly downloaded and saved to avoid loss of patient information.
Non-MolecuLight Apps may appear on the MolecuLight i:X for download. Do not download any non-
Caution
MolecuLight Apps in order to maintain the device configuration intended for use.
2.1.3 Acronym Table
Acronym
RF
ST-image TM
TM
ST-video
FL-image TM
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F.
Meaning
Radio Frequency
An image captured in Standard Imaging Mode
A video captured in Standard Imaging Mode
An image captured in Fluorescence Imaging Mode
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