MolecuLight i:X User manual

MolecuLight i:XTM User Manual
MolecuLight i:XTM User Manual Revision 1.1 Page 2 of 43
Trademarks
MolecuLightTM, MolecuLight i:XTM, MolecuLight DarkDrapeTM, MolecuLight AdapterTM, Standard Imaging ModeTM,
Fluorescence Imaging ModeTM, ST-imageTM, ST-videoTM, FL-imageTM, FL-videoTM are trademarks of MolecuLight, Inc.
Patent Information
The MolecuLight i:XImaging Device (hereafter referred to as the device, MolecuLight i:X or MolecuLight i:X Imaging Device)
contains patented technology developed by MolecuLight Inc.:
Canadian Patent No. 2,724,973
U.S. Patent No. 12/992,040
Global patents and further U.S. patents are pending.
Publication Information
User Manual, Part Number 1294, Revision 1.1
Contact Information
The MolecuLight i:Xand its accessories are designed and manufactured by MolecuLight Inc.
MolecuLight Inc.
425 University Ave., Suite 700
Toronto, Ontario, Canada
M5G 1T6
Telephone: [phone], or 1-877-818-4360 (North America Only)
Fax: [phone]
Email: [email protected]om
www.moleculight.com
The European authorized representative for MolecuLight Inc. is Emergo.
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands

MolecuLight i:XTM User Manual Revision 1.1 Page 3 of 43
Contents
1INTRODUCTION ........................................................................................................................................................................ 5
2WARNINGS, CAUTIONS, AND NOTES ........................................................................................................................................ 5
2.1 WARNINGS,CAUTIONS,AND NOTES ..........................................................................................................................................................5
2.1.1 General Warning Messages...........................................................................................................................................................5
2.1.2 General Caution Messages ............................................................................................................................................................6
2.1.3 Acronym Table ..............................................................................................................................................................................7
2.2 SYMBOLS ..............................................................................................................................................................................................7
2.2.1 Symbols Used on the MolecuLight i:X Imaging Device Label ........................................................................................................ 7
2.2.2 Symbols Used on MolecuLight i:X .................................................................................................................................................8
2.2.3 Symbols Used on MolecuLight i:X Packaging ................................................................................................................................8
2.2.4 Symbols Used for MolecuLight DarkDrape Label ..........................................................................................................................9
2.2.5 Symbols Used for MolecuLight DarkDrape Package Label ............................................................................................................9
2.3 CERTIFICATIONS .....................................................................................................................................................................................9
2.3.1 Classifications ..............................................................................................................................................................................10
2.4 ELECTROMAGNETIC COMPATIBILITY .........................................................................................................................................................10
2.5 INFORMATION ON LASER RADIATION OUTPUT............................................................................................................................................10
3CONTENTS .............................................................................................................................................................................. 11
3.1 MOLECULIGHT I:XSYSTEM CONTENTS .....................................................................................................................................................11
3.2 MOLECULIGHT I:XACCESSORIES AND CONSUMABLES..................................................................................................................................11
4MOLECULIGHT I:X IMAGING DEVICE OVERVIEW..................................................................................................................... 12
4.1 MOLECULIGHT I:X IMAGING DEVICE DESCRIPTION AND USE .........................................................................................................................12
4.2 HOW MOLECULIGHT I:XCREATES IMAGES IN FL-MODE ..............................................................................................................................14
4.3 MOLECULIGHT DARKDRAPE AND MOLECULIGHT ADAPTER DEVICE DESCRIPTION AND USE.................................................................................15
5INTENDED USE AND INDICATION FOR USE ............................................................................................................................. 15
5.1 OFF LABEL USE ....................................................................................................................................................................................15
6DEVICE BASICS........................................................................................................................................................................ 15
6.1 POWER BUTTON ..................................................................................................................................................................................16
6.1.1 Status Indicator LEDs...................................................................................................................................................................17
6.1.1.1 System Status LED..........................................................................................................................................................................17
6.1.1.2 Range Finder LED ...........................................................................................................................................................................17
6.1.1.3 Ambient Light Status LED ...............................................................................................................................................................18
6.1.1.4 Battery Status LED..........................................................................................................................................................................19
6.1.2 Rocker Switch ..............................................................................................................................................................................19
7QUICK START GUIDE ............................................................................................................................................................... 19
8ENVIRONMENTAL CONDITIONS THAT AFFECT USE ................................................................................................................. 20
8.1 LIGHTING............................................................................................................................................................................................20
8.2 OPERATING TEMPERATURE ....................................................................................................................................................................20
8.3 STORAGE ............................................................................................................................................................................................20
9OPERATING INSTRUCTIONS.................................................................................................................................................... 20
9.1 PROPER IMAGING TECHNIQUE ................................................................................................................................................................20
9.2 HANDLING MOLECULIGHT I:X.................................................................................................................................................................21
9.3 IMAGING WITH MOLECULIGHT I:X(IXCAMERA APP) ..................................................................................................................................22
9.3.1 Capture an Image ........................................................................................................................................................................22
9.3.1.1 Capture an ST-image ........................................................................................................... ...........................................................22
9.3.1.2 Capture an FL-image ......................................................................................................................................................................23
9.3.1.3 Capture a video ..............................................................................................................................................................................23
9.3.1.4 Capture an ST-video .......................................................................................................................................................................23
9.3.1.5 Capture an FL-video .......................................................................................................................................................................24
9.4 REVIEW IMAGES AND/OR VIDEOS USING THE IMAGE LIBRARY .......................................................................................................................25
MolecuLight i:XTM User Manual Revision 1.1 Page 4 of 43
9.5 USING THE ALBUM FEATURE (OPTIONAL) .................................................................................................................................................25
9.5.1 Creating a New Album.................................................................................................................................................................26
9.5.2 Accessing and Using Previously Created Albums ........................................................................................................................27
9.5.3 Capture Image and Video Capture Screens.................................................................................................................................28
9.5.3.1 Capture Screens when the Active Album is the Camera Roll .........................................................................................................28
9.5.3.2 Capture Screens when the Active Album is Created ......................................................................................................................28
9.5.4 Deleting Albums ..........................................................................................................................................................................28
9.6 ZOOMING IN AND OUT AND PANNING ......................................................................................................................................................29
9.6.1 Zooming in and out .....................................................................................................................................................................29
9.6.2 Panning........................................................................................................................................................................................29
9.7 DELETING IMAGES AND VIDEOS ...............................................................................................................................................................29
9.8 CHARGING MOLECULIGHT I:X.................................................................................................................................................................29
9.8.1 Charge the MolecuLight i:X Imaging Device................................................................................................................................30
9.8.2 Charge the MolecuLight i:X Display Screen.................................................................................................................................30
9.9 UPLOADING IMAGES AND VIDEOS TO COMPUTER .......................................................................................................................................30
9.10 DISPLAY SCREEN FUNCTIONALITY.............................................................................................................................................................31
9.10.1 Basic Display Screen Functionality for MolecuLight i:X Use....................................................................................................31
9.10.1.1 Home Button..................................................................................................................................................................................31
9.10.2 Connect to a Wi-Fi Network....................................................................................................................................................32
9.10.3 Connect to the Internet ..........................................................................................................................................................32
9.10.4 Create a Passcode ...................................................................................................................................................................32
10 MEASURING WOUND AREA ................................................................................................................................................... 33
10.1 SETTINGS MENU ..................................................................................................................................................................................33
10.1.1 Wound Border Thickness ........................................................................................................................................................33
10.1.2 Display of Length & Width Dimensions...................................................................................................................................33
10.1.2.1 Length & Width ................................................................................................................ ..............................................................34
10.1.2.2 Vertical & Horizontal......................................................................................................................................................................34
10.2 AUTO MODE .......................................................................................................................................................................................34
10.3 MANUAL MODE...................................................................................................................................................................................35
10.3 SAVING A WOUND MEASUREMENT .........................................................................................................................................................35
11 INTERPRETATION OF FLUORESCENCE IMAGES ....................................................................................................................... 35
11.1 COLOR BLINDNESS................................................................................................................................................................................36
12 CLEANING AND DISINFECTING MOLECULIGHT I:X................................................................................................................... 37
12.1 PRE-CLEAN THE MOLECULIGHT I:X ..........................................................................................................................................................37
12.2 DISINFECT THE MOLECULIGHT I:X............................................................................................................................................................37
12.3 CLEAN THE MOLECULIGHT I:X.................................................................................................................................................................37
12.4 PRE-CLEAN THE MOLECULIGHT ADAPTER .................................................................................................................................................38
12.5 DISINFECT THE MOLECULIGHT ADAPTER ...................................................................................................................................................38
13 MAINTENANCE OF MOLECULIGHT I:X ..................................................................................................................................... 38
14 DISPOSAL OF MOLECULIGHT I:X ............................................................................................................................................. 38
15 TROUBLESHOOTING AND SUPPORT ....................................................................................................................................... 38
15.1 FREQUENTLY ASKED QUESTIONS .............................................................................................................................................................38
15.2 IXCAMERA APP TROUBLESHOOTING ........................................................................................................................................................41
16 WARRANTY ............................................................................................................................................................................ 42
APPENDIX A: SPECIFICATIONS ............................................................................................................................................................ 43
APPENDIX B: MOLECULIGHT I:X IMAGING DEVICE OVERVIEW
APPENDIX C: MOLECULIGHT I:X IMAGING DEVICE QUICK START GUIDE
APPENDIX D: MOLECULIGHT DARKDRAPE AND ADAPTER INSTRUCTIONS FOR USE
APPENDIX E: MOLECULIGHT I:X WOUND MEASUREMENT QUICK START GUIDE

MolecuLight i:XTM User Manual Revision 1.1 Page 5 of 43
1Introduction
Congratulations on your purchase of the MolecuLight i:XTM Imaging Device. The handheld MolecuLight i:XImaging Device
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:XImaging 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:XImaging Device. Please review this User Manual thoroughly before operating your
device.
2Warnings, Cautions, and Notes
Please read the following safety information before using the MolecuLight i:XImaging Device.
The MolecuLight i:Xis 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:XImaging
Device does not require the use of exogenous imaging contrast agents.
The MolecuLight i:Xis 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:Xis 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:
Warning
Messages with this heading indicate serious adverse reactions, potential safety hazards, and
limitations in use imposed by a condition labeled with a warning. The warning identifi
es steps that
should be taken if the incident occurs.
Caution
Messages with this heading indicate information regarding any special care to be exercised by the user
and/or patient for the safe and effective use of the device. All caution statements should be followed
to ensure data and device integrity.
Note
Messages with this heading provide additional information that increase the user’s understanding of
the operation of the device.
2.1.1 General Warning Messages
Warning
The use of an accessory or cable with the MolecuLight i:XImaging Device other than those specified in
Section
3 may result in increased emissions or decreased immunity of the MolecuLight i:XImaging
Device.
MolecuLight i:XTM User Manual Revision 1.1 Page 6 of 43
Warning
The MolecuLight i:XImaging Device comes fully assembled and ready for use. No modification of this
equipment is allowed. Modification of the device will void the terms of the warranty.
Warning
Do not stack the
MolecuLight i:XImaging Device.
Warning
MolecuLight i:Xis intended to be used in a hospital/clinic by trained health care professionals. Avoid
exposure to magnetic fields, electrostatic discharge and thermal ignition sources
during use of the
device.
Warning
Do not charge or use the device in areas with potentially explosive atmospheres such as fueling areas
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).
Warning
MolecuLight i:Xis not suitable for use in the presence of flammable anesthetic mixtures with air,
oxygen or nitrous oxide.
Warning
Protect MolecuLight i:Xagainst dust and moisture by storing it in its original shipping package
overnight or when not in use for prolonged periods of time.
Warning
Avoid strong physical shocks and dropping.
Warning
Any damage to the device (crack or other visible deformity) may affect the functional, intended use
and/or safety of the MolecuLight i:X. Contact MolecuLight for guidance at supp[email protected].
Warning
Do not soak or immerse MolecuLight i:Xin water or other liquids.
Warning
Be aware of surroundings when operating MolecuLight i:Xin a dark environment. The environment
should be safe to prevent tripping or bumping into any objects
during fluorescence imaging
procedures.
Warning
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the MolecuLight i:X,
including cables that may be specified by MolecuLight Inc. Otherwise, degradation of the performance
of MolecuLight i:Xcould result.
2.1.2 General Caution Messages
Caution
Do not attempt to use the device while it is charging. The device will not function.
Caution
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
window with your fingers, as this may affect illumination and image quality (see Figure 2, item 15).
Caution
Prior to charging the device, ensure the MolecuLight Power Cable P/N 1142 (described in Section 3.1)
is undamaged before plugging into a wall outlet. Use of an extension cord or an electrical power bar is
discouraged.
Caution
When charging is complete, the MolecuLight Power Cable P/N 1142 should initially be disconnected
from the wall electrical outlet and then removed from the MolecuLight i:XImaging Device.
Caution
Use of controls, adjustments or procedures other than those specified in this User Manual may result
in hazardous laser light radiation exposure from the Range Finder Sensor (Section 2.5).
Caution
The MolecuLight i:XImaging Device is restricted to use by trained health care professionals and should
be protected from unauthorized use.
Caution
The Heat Sink (Figure 2, item 7) may get warm after prolonged use. The device will shut down if
temperature exceeds 460C or 1150F.
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.
Caution
Non-MolecuLight Apps may appear on the MolecuLight i:Xfor download. Do not download any non-
MolecuLight Apps in order to maintain the device configuration intended for use.

MolecuLight i:XTM User Manual Revision 1.1 Page 7 of 43
2.1.3 Acronym Table
Acronym
Meaning
RF
Radio Frequency
ST-imageTM
An image captured in Standard Imaging Mode
ST-videoTM
A video captured in Standard Imaging Mode
FL-imageTM
An image captured in Fluorescence Imaging Mode
FL-videoTM
A video captured in Fluorescence Imaging Mode
LED
Light Emitting Diode
2.2 Symbols
2.2.1 Symbols Used on the MolecuLight i
i:
XImaging Device Label
The following table lists the symbols and statements used on the MolecuLight i:XImaging Device label (silver label).
Symbol
Meaning
Caution, consult accompanying documents
Read User Manual
Date of manufacture
Catalog number
Serial number
Certification of safety testing
Dispose of the MolecuLight i:Xin accordance with your country’s legal requirements for the disposal
of electrical and electronic waste
RF transmitter for wireless transmission
Device duty cycle (if device is
continuously on for 15 minutes in Fluorescence Imaging Mode, violet
LEDs should be turned off for 5 minutes before Fluorescence Imaging Mode is accessed again)
CE Marking indicates European Conformity to essential requirements of applicable European
product directives; 0123 represents MolecuLight Inc.’s Notified Body
Rx only
For prescription use
Statement
Meaning
CAN ICES-3(B)/NMB-3(B)
Self-Declaration of Compliance (SDoC) to Industry Canada ICES-003(B)
The MolecuLight i:X Imaging Device
complies with Part 15 of the FCC Rules
For further information related to this statement, refer to Section 2.3
for specific certification and Section 2.4
for electromagnetic
compatibility
For use only with Power Cable P/N:
1142. A utiliser uniquement avec Câble
N/P: 1142
For further information related to accessories and consumables, refer
to Section 3
Contains FCC ID:BCG-A1421 and IC:579C-
A1421
In reference to iPod touch (part of the MolecuLight i:X, referred to as
the Display Screen)
Table 1: Symbols and statements on MolecuLight i:XImaging Device label
MolecuLight i:XTM User Manual Revision 1.1 Page 8 of 43
2.2.2 Symbols Used on MolecuLight i
i:
X
The following table lists the symbols used in the labeling of MolecuLight i:X.
Symbol
Source & Meaning
Symbol
Source & Meaning
Source: IEC 60417-5010
Meaning: Power Button
Source: MolecuLight symbol
Meaning: Ambient Light Status
Source
: MolecuLight symbol
Meaning
: Display Screen Power Button
Source: MolecuLight symbol
Meaning: Port for Charging Display Screen and
Data Transfer
Source: MolecuLight symbol
Meaning: System Status
Source: MolecuLight symbol
Meaning: Fluorescence Imaging Mode
Source: IEC 60417-5546
Meaning: Battery Status
Source: MolecuLight symbol
Meaning: Standard Imaging Mode
Source: IEC 60417-5031
Meaning
: MolecuLight i:XCharging Port
(D.C)
Source
: MolecuLight symbol
Meaning
: Home Button (for Display Screen)
Source: MolecuLight symbol
Meaning: Range Finder
Table 2: MolecuLight i:Xsymbols
2.2.3 Symbols Used on MolecuLight
i:
XPackaging
The following table lists the symbols and statements used on the MolecuLight i:Xpackaging label and indicates storage and
transportation conditions.
Symbol
Source & Meaning
Symbol
Source & Meaning
Source: ISO 15223-1:2012
Meaning:
Maintain within -10o
C
to 50
oC (14oF to 122o
F) ambient
temperature
Source: WEEE symbol, EU Directive 2012/19/EU
Meaning:
Dispose of the MolecuLight i:Xin
accordance with your country’s legal requirements for
the disposal of electrical and electronic waste
Source:
ISO 15223-1:2012
Meaning:
Non sterile
Source:
ISO 15223-1:2012
Meaning:
Maintain within 10% to 70% humidity
Source:
ISO 15223-1:2012
Meaning:
Fragile
Source: ISO 15223-1:2012
Meaning:
Maintain within 89 kPa to 102 kPa for
atmospheric pressure
Source:
ISO 7000:2014
Meaning:
Face up
Source:
MolecuLight symbol
Meaning:
Do not stack or compress
Source:
ISO 7000:2014
Meaning
: Recyclable
Source:
ISO 15223-1:2012
Meaning
: Keep dry
Table 3: MolecuLight i:Xtransportation and storage conditions

MolecuLight i:XTM User Manual Revision 1.1 Page 9 of 43
2.2.4 Symbols Used for MolecuLight DarkDrape Label
The following table lists the symbols and statements used on the MolecuLight DarkDrape label.
Symbol
Source & Meaning
Symbol
Source & Meaning
Source:
ISO 15223-1:2012
Meaning:
Catalog number
Source:
ISO 15223-1:2012
Meaning:
Do not use if package is damaged
Source:
ISO 15223-1:2012
Meaning:
Batch code
Source:
ISO 15223-1:2012
Meaning:
For single use only
Source:
ISO 15223-1:2012
Meaning:
Date of manufacture
Source:
ISO 15223-1:2012
Meaning:
Non sterile
Source:
ISO 7010:2011
Meaning:
Read User Manual
Source:
IEC 60417 – 5840
Meaning:
Type B applied part
Source:
ISO 15223-1:2012
Meaning:
Caution, consult
accompanying documents
Source: European Conformity Marking
Meaning:
Manufacturer's declaration that the
product meets the requirements of the applicable EC
directives
Table 4: Symbols and statements on the MolecuLight DarkDrape label
2.2.5 Symbols Used for MolecuLight DarkDrape Package Label
The following table lists the symbols and statements used on the MolecuLight DarkDrape packaging label.
Symbol
Source & Meaning
Symbol
Source & Meaning
Source
: ISO 15223-1:2012
Meaning
: Catalog number
Source:
ISO 15223-1:2012
Meaning
: Keep dry
Source
: ISO 15223-1:2012
Meaning:
Batch code
Source:
ISO 15223-1:2012
Meaning
: Do not use if package is damaged
Source:
ISO 15223-1:2012
Meaning
: Date of manufacture
Source:
ISO 15223-1:2012
Meaning
: For single use only
Source:
ISO 7010:2011
Meaning
: Read User Manual
Source:
ISO 15223-1:2012
Meaning
: Non sterile
Source:
ISO 15223-1:2012
Meaning
: Fragile
Source:
IEC 60417 – 5840
Meaning
: Type B applied part
Source:
ISO 15223-1:2012
Meaning:
Caution, consult
accompanying documents
Source: European Conformity Marking
Meaning:
Manufacturer's declaration that
the product meets the requirements of the
applicable EC directives
Table 5: Symbols and statements on the MolecuLight DarkDrape package label (10-pack and 50-pack)
2.3 Certifications
The MolecuLight i:XImaging Device complies with the following standards:
xSafety Testing per IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013
including Canadian National Differences per CAN/CSA-C22.2 No. 60601-1:14 and
US National Differences per ANSI/AAMI ES 60601-1:2005/A1:2012
xSafety EMC Testing per IEC 60601-1-2:2014 4th Edition / EN 60601-1-2:2015
xSafety LED testing per IEC 60601-2-57:2011 and IEC 62471:2006 / EN 60601-2-57:2011 and EN 62471:2008
xUsability Testing per IEC 60601-1-6:2010+A1:2013 / EN 60601-1-6:2010 and EN 62366:2008
xRisk Management per ISO 14971:2007 / EN ISO 14971:2012
MolecuLight i:XTM User Manual Revision 1.1 Page 10 of 43
xQuality Management System Requirements per ISO 13485:2016 / EN ISO 13485:2016
The MolecuLight DarkDrape complies with ISO 10993-1:2009 / EN ISO 10993-1:2009: Biological evaluation of medical
devices.
2.3.1 Classifications
MolecuLight i:Xhas an operational duty cycle of 15 minutes on, 5 minutes off. The implication for this duty cycle is that if
the MolecuLight i:Xis continuously used in Fluorescence Imaging Mode for 15 minutes, the device will need to be switched
to Standard Imaging Mode for 5 minutes before selecting Fluorescence Imaging Mode again to allow for optimal
performance of the Violet Wavelength LEDs.
The medical device classification of the MolecuLight i:Xin Canada is Class II medical device and a Class IIa medical device in
Europe. Alone, the MolecuLight i:Xdoes not require patient contact for use. The MolecuLight DarkDrape (used in
combination with the MolecuLight Adapter and MolecuLight i:Xto achieve an optimal lighting environment for imaging
wounds) is a Type B patient applied part which complies with medical device biocompatibility requirements.
The MolecuLight i:Xis classified as “IPX0” for fluid ingress, therefore it has no inherent protection against damage from
exposure to liquids.
2.4 Electromagnetic Compatibility
The MolecuLight i:XImaging Device meets the requirements of Safety EMC Testing per IEC 60601-1-2:2014 4th Edition / EN
60601-1-2:2015. Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC)
and must be used according to the instructions in this User Manual.
While unlikely, it is possible that high levels of emitted radio-frequency (RF) electromagnetic interference (EMI) from other
portable and mobile RF communications equipment or nearby radio-frequency sources could result in performance
disruption of the MolecuLight i:XImaging Device.
To avoid the risk of increased electromagnetic emissions or decreased immunity from such emissions, use only accessories
recommended by MolecuLight (i.e. MolecuLight Power Cable, see Section 3.1). Connection of accessories not recommended
by MolecuLight will void product warranty and could result in malfunctioning of the MolecuLight i:XImaging Device or other
devices located in the area.
This device complies with Part 15 of the US FCC Rules. This device complies with Canadian ICES-003 (B).
Note
The emissions characteristics of the MolecuLight i:Xmake it suitable for use in industrial areas and
hospitals (CISPR 11 class A).
MolecuLight i:Xis not intended for use in a residential environment
and does
not comply with
IEC 60601-1-11:2015 General requirements for basic safety and essential performance --
Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment.
2.5 Information on Laser Radiation Output
The MolecuLight i:XImaging Device uses a miniature pulsed laser-based range finder to determine the optimal distance
between the device and the wound for superior image quality. The laser module in the range finder emits light at 850 nm
which is invisible to the human eye. The laser’s individual pulse duration is 3.33 ns and the pulse train is 52.3 ms at a 200 ms
repetition rate. The laser complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.50.
The laser is a Class 1 certified laser
Caution
Do not point the laser (from the
Range Finder sensor) into eyes (Figure 2, item 14).

MolecuLight i:XTM User Manual Revision 1.1 Page 11 of 43
3Contents
Figure 1: MolecuLight i:XImaging Device and its components
3.1 MolecuLight i
i:
XSystem Contents
The MolecuLight i:XImaging Device comes fully assembled and ready for use. The standard system configuration includes
items 1-6 illustrated in Figure 1 and detailed in Table 6 below. These items allow the MolecuLight i:XImaging Device to be
used in a patient care setting.
# in
Figure 1
Item Description
1
MolecuLight i:XImaging Device
Device operates on Apple iOS software
2
MolecuLight Power Cable
Cable to charge the MolecuLight i:XImaging Device and download
images/videos to a computer; Includes geography
-
specific plug adaptors (where
applicable)
3
Quick Start Guide
Step by step guide for MolecuLight i:Xuse
4
User Manual
Provides detailed instructions on use of the MolecuLight i:X
5
Optical
Lens Wipes
5 x Optical lens cleaning towelettes, individually packaged for cleaning display
screen and optical windows (ProWorks)
6
MolecuLight WoundStickers
1 box of 2,000 stickers for wound area measurement with the MolecuLight i:X
Table 6: List of items included with the MolecuLight i:XSystem (P/N 1153)
Note
The MolecuLight DarkDrape and MolecuLight Adapter (Figure 1, items 7-8) are not part of the
MolecuLight i:XSystem configuration. They are optional accessories that may be ordered separately.
3.2 MolecuLight
i:
XAccessories and Consumables
MolecuLight i:Xaccessories and consumables are listed below in Table 7 along with suggested vendors from which the
items may be purchased (if not available from MolecuLight).
MolecuLight i:XTM User Manual Revision 1.1 Page 12 of 43
To reorder items available from MolecuLight, contact MolecuLight by email: [email protected].
# in
Figure 1
Item Description
MolecuLight
Part #
Reorder from MolecuLight
2
MolecuLight
Power Cable
Cable to charge the MolecuLight i:XImaging
Device
and download images/videos to a
computer; Includes geography
-specific plug
adaptors (where applicable)
1142 Yes
3
Quick Start Guide
Step by step guide for MolecuLight i:Xuse
1295
Yes
4
User Manual
Provides detailed instructions on use of the
MolecuLight i:X
1294 Yes
5
Optical Lens
Wipes
(Box of
100)
Box of 100 optical lens cleaning towelettes,
individually packaged for cleaning
display
screen
and optical windows (ProWorks)
1182 Yes
6
MolecuLight
WoundStickers
1 box of 2,000 stickers for wound area
measurement with the MolecuLight i:X
1266 Yes
7
MolecuLight
Adapter
Reusable Adapter to connect MolecuLight
DarkDrape to the MolecuLight
i:Xto create an
optimal lighting environment for imaging wounds
1215 Yes
8
MolecuLight
DarkDrape
(Case
of 50)
Case of 50 MolecuLight DarkDrapes, individually
packaged for one
-
time use to create an optimal
lighting environment for imaging wounds
1212 Yes
N/A
eo
TECHSPEC
Lens Cleaning
Solution
Lens cleaning solution t
o clean the device’s
optical components
(Edmund Optics) N/A
No; available from Edmund
Optics, Fisher Scientific,
VWR, Staples.com,
Amazon.com
N/A
Fisherbrand Lens
Paper (4’’x
6’’)
Len paper t
o clean the device device’s optical
components
(Fisher Scientific) N/A
No; available from Fisher
Scientific,
VWR,
Staples.com, Amazon.com
N/A
CaviWipes
Disinfecting wipes to clean the device between
uses (Metrex)
N/A
No; available from Metrex,
K
-Dental, Amazon.com,
Fisher Scientific
Table 7: List of recommended MolecuLight i:Xaccessories and consumables
Warning
Do not connect the MolecuLight i:XImaging Device to a power supply using cables that have not
been approved by MolecuLight.
Note
Lens Cleaning Solution and Lens Paper may be used instead of the Lens Cleaning
Towelette.
Detailed information about cleaning and disinfecting the MolecuLight i:Xis provided in Section 12.
4MolecuLight i
i:
XImaging Device Overview
4.1 MolecuLight
i
:X Imaging Device Description and Use
The MolecuLight i:XImaging Device allows clinicians to quickly, safely and easily visualize potentially harmful bacterial
presence and distribution on skin and in wounds, in real-time at the point-of-care. The device is non-contact and no imaging
contrast agents are required for fluorescence imaging.
The MolecuLight i:XImaging Device is a handheld medical device comprised of a high-resolution color LCD display and
touch-sensitive screen with integrated optical and microelectronic components. MolecuLight i:Xuses its patented
technology to enable real-time standard light and fluorescence imaging of bacteria and tissue components in wounds and
surrounding healthy skin of patients.
The MolecuLight i:XImaging Device captures real-time images (JPEG format) and videos (MOV format) in Standard Imaging
ModeTM and Fluorescence Imaging ModeTM. These modes are identified as follows:

MolecuLight i:XTM User Manual Revision 1.1 Page 13 of 43
1. Standard Imaging ModeTM (or ST-Mode): Real-time imaging as per standard photography.
In Standard Imaging Mode, MolecuLight i:Xis able to capture the following images:
a. ST-imageTM: An image captured in Standard Imaging Mode
b. ST-videoTM: A video captured in Standard Imaging Mode
Note
Wound measurement is
only possible on an ST-Image (see Section 10).
2. Fluorescence Imaging ModeTM (or FL-Mode): Real-time imaging in Fluorescence Imaging Mode as a result of violet light
illumination. In Fluorescence Imaging Mode, MolecuLight i:Xis able to capture the following images:
a. FL-imageTM: An image captured in Fluorescence Imaging Mode
b. FL-videoTM: A video captured in Fluorescence Imaging Mode
The device provides image-guidance during visual assessment of wounds.
The device can capture an ST-imageTM, ST-videoTM, FL-imageTM, and FL-videoTM of wounds to quickly identify the presence
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:XImaging 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
MolecuLight i:XTM User Manual Revision 1.1 Page 14 of 43
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
Note
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
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:XCharging 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:
xReading this User Manual in its entirety
xFollowing the Quick Start Guide (Appendix C) and the MolecuLight i:XImaging Device Overview (Appendix B)
xFollowing the MolecuLight DarkDrape & MolecuLight Adapter Instructions for Use (Appendix D) and the MolecuLight i:X
Wound Measurement Quick Start Guide (Appendix E)
Caution
The MolecuLight i:XImaging Device is restricted to use by trained health care professionals and
should be protected from unauthorized use.
4.2 How MolecuLight i
i:
XCreates Images in FL-Mode
The MolecuLight i:Xincludes 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:Xuses violet light illumination to create real-time fluorescence images.
Caution
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
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:XReal-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.

MolecuLight i:XTM User Manual Revision 1.1 Page 15 of 43
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 Dar
kDrape. It is for single use only.
Caution
Do not over
tighten the drawstring when securing the MolecuLight DarkDrape to the patient.
Caution
Avoid
touching the wound with the MolecuLight DarkDrape.
Caution
Be aware of compromised visibility of the imaging target when using the MolecuLight DarkDrape to
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.
5Intended Use and Indication for Use
The MolecuLight i:Xinstantly 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:Xcan 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:Xis intended only to be used with the iX Camera App for purposes of image or video
documentation of wounds. Using the MolecuLight i:Xfor other purposes, or using Apps other than the iX Camera App which
may be available on the MolecuLight i:Xdevice is considered off label use.
6Device Basics
The device consists of two primary elements:
1. MolecuLight i:XImaging 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.
MolecuLight i:XTM User Manual Revision 1.1 Page 16 of 43
The MolecuLight i:XImaging Device contains a rechargeable battery which needs to be kept charged in order for
MolecuLight i:Xto work properly. Refer to Section 9.8 for details about charging the
MolecuLight i:X.
Primary features on the MolecuLight i:XImaging Device include:
xRocker Switch
xTwo Power Buttons
xFour Status indicator LEDs (see Figure 4)
xTwo 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:
x4-inch (diagonal) widescreen display with Multi-Touch technology
x1136-by-640-pixel resolution at 326 pixel per inch
x800:1 contrast ratio (typical)
x500 cd/m2max brightness (typical)
xFingerprint-resistant oleophobic coating
The Display Screen contains a rechargeable battery, which needs to be kept charged in order for MolecuLight i:Xto 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.
Note
The Display Screen and the MolecuLight i:XImaging Device each contain separate rechargeable
batteries. Both batteries need to be charged separately in order for MolecuLight i:Xto work
properly. Refer to Section 9.8 for details about charging the MolecuLight i:X.
Figure 4: Schematic rendering of MolecuLight i:XImaging 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:XImaging 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:Xto one of the following states:
xOFF: the MolecuLight i:Xis powered off
xON: the MolecuLight i:Xis powered on (Violet Wavelength LEDs turn on after Fluorescence Imaging Mode is
selected)
Note
The ON/OFF state of the MolecuLight i:Xis independent of the ON/OFF/SLEEP state of the Display
Screen. Refer to Section 9.10 for details about the ON/OFF state of the Display Screen.

MolecuLight i:XTM User Manual Revision 1.1 Page 17 of 43
The Power Button functions as follows:
Action
Effect
If the MolecuLight i:X is OFF, press and
hold the Power Button for 3 seconds
Switches MolecuLight
i:Xfrom OFF to ON.
If the MolecuLight i:X is ON, press and
hold the Power Button for 3 seconds
Switches MolecuLight
i:X from ON to OFF.
If the MolecuLight
i:X is ON during
Fluorescence Imaging Mode for greater
than
90 seconds
Switches Violet Wavelength LEDs from ON to OFF automatically (to
conserve battery).
Note You will need to move the Rocker Switch to Standard Imaging
Mode and then back to Fluorescence Imaging Mode to activate the
Violet
Wavelength LEDs.
If the MolecuLig
ht i:X is ON and you
don’t touch MolecuLight
i:X for 30
min
utes
Switches the MolecuLight i:Xfrom ON to OFF automatically after 30
min
utes (timing out to conserve battery).
Note If the Rocker Switch is in the Fluorescence Imaging Mode
position when powering the MolecuLight
i:XON, you need to move the
Rocker
Switch to Standard Imaging Mode and then back to Fluorescence
Imaging Mode to turn on the Violet Wavelength LEDs.
Reset
function (to be used when the
device or any of its functions are not
functioning as intended)
To reset the MolecuLight i:X, switch the device off, then hold the Power
B
utton for 8 seconds. The System Status LED will blink red initially, then
yellow
and then red again twice. This sequence indicates a reset was
performed.
Remove finger from button once this sequence is observed.
Press the Power Button again for 2-3 seconds to turn on the device.
Table 8: Power Button functions
6.1.1 Status Indicator LEDs
The MolecuLight i:Xis designed with four sensors to guide you in capturing optimal images/videos. Each sensor has a
corresponding indicator light (LED) on the MolecuLight i:X.
6.1.1.1 System Status LED
MolecuLight i:Xperiodically executes a self-diagnosis to ensure it is operating properly. The System Status LED
indicates the overall operational state of the MolecuLight i:XImaging Device.
Indicator
Meaning
Solid Green Light
MolecuLight i:XImaging Device is functioning as expected.
Solid Yellow Light
You can continue imaging, however follow up with MolecuLight as soon as possible.
Solid
Red Light
The device has malfunctioned. Stop using the device immediately and contact
MolecuLight to troubleshoot the problem.
Red Light, Yellow Light, and 2
Red Light flashes
The device is going through a reset (after the Power Button has been pressed).
Table 9: System Status LED
Note
When the device is OFF, no System Status LED color is visible. When you power on the device, the
System Status LED
blinks green 5 times for 2 seconds, staying solid green on the 5th blink. Blinking
indicates that the device is performing its self-diagnostic routine.
6.1.1.2 Range Finder LED
MolecuLight i:XTM User Manual Revision 1.1 Page 18 of 43
MolecuLight i:Xis equipped with a pulsed laser-based Range Finder sensor which is used to determine the distance
between MolecuLight i:Xand the wound. The Range Finder LED indicates to the user when the device is held at the correct
distance for optimal imaging.
LED Indicator
Meaning
Green Light
The optimal distance (8-12 cm) between MolecuLight i:Xand the wound being imaged has been
reached. See Figure 8.
Amber Light
The distance between MolecuLight i:Xand the wound is out of its optimal range (i.e. closer than 8 cm
or further than 12 cm) and/or the Range Finder sensor is unable to determine the device-to-wound
distance. The user can adjust the device-to-wound distance to obtain a Green Light for imaging.
Table 10: Range Finder LED
Note
The Range Finder LED turns green when the distance between Range Finder and the wound is within 8-12
cm.
The Range Finder LED should be used when in FL-Mode. It is also strongly recommended to be used when in ST-
Mode to obtain images with similar sizes (for presentation or comparison purposes).
The Range Finder LED should always be used when measuring wound area per Section 10.
Caution
Capturing a FL-image or FL-video outside the recommended device-to-wound distance may result in
suboptimal fluorescence and/or image quality.
Caution
A defect in the Range Finder’s function may result in distorted/inaccurate images/videos. See Section
15 Troubleshooting & Support, question 18 on how to verify the Range Finder function.
6.1.1.3 Ambient Light Status LED
FL-images and FL-videos need to be captured in a dark environment for optimal fluorescence image quality. The Ambient
Light Status LED indicates if the level of ambient light in the examination room is optimal for Fluorescence Imaging to aid
users in capturing optimal fluorescence images and videos.
Note
The Ambient Light Status LED is only ON in Standard Imaging Mode. It turns off in Fluorescence Imaging
Mode.
For use with Fluorescence Imaging Mode, view the Ambient Light Status LED immediately after turning off room lights and
prior to toggling the Rocker Switch to Fluorescence Imaging Mode.
Indicator
Meaning
Green Light
The ambient light level in the imaging environment is adequate for fluorescence imaging.
Amber Light
The ambient light level is too high and fluorescence images should not be captured.
The user should reduce the ambient light settings by turning off the room lights, blocking windows, turning
off computer monitors or other means until the Ambient Light Status LED turns green.
Note If you are unable to obtain optimal ambient light for Fluorescence Imaging Mode, MolecuLight
recommends using MolecuLight DarkDrape (used in conjunction with MolecuLight Adapter). For more
information, refer to Section 4.3 or contact MolecuLight.
Table 11: Ambient Light Status LED
Note
The Ambient Light Status LED is not active or ON when the Violet Wavelength LEDs are turned on
for imaging in Fluorescence Imaging Mode. In Fluorescence Imaging Mode, the Ambient Light
Status LED is OFF.
Caution
A defect in the Ambient Light Status LED may result in inaccurate images.
Caution
Ignoring the Ambient Light
Status LED indicator may result in inaccurate images.

MolecuLight i:XTM User Manual Revision 1.1 Page 19 of 43
6.1.1.4 Battery Status LED
The Battery Status LED indicates the MolecuLight i:XImaging Device battery charge level.
Note
This LED indicates the battery status for the MolecuLight i:XImaging Device only. The Display
Screen’s battery status and charging status operates independently of this functionality and is
displayed on the screen.
Indicator
Meaning
Solid Green Light
The MolecuLight i:Xbattery is fully charged or at high power (over 80% power).
Solid
Yellow Light
The MolecuLight i:Xbattery power is between 20-80% power and MolecuLight i:Xcharging is
advised.
Solid Red Light
The battery power has dropped below 20% power and the MolecuLight i:Xrequires immediate
charging.
Table 12: Battery Status LED
When the MolecuLight i:XImaging Device is OFF, the Battery Status LED is OFF, except when the battery is critically low and
not charging, at which point the LED blinks red every 2 seconds.
When the MolecuLight i:XImaging Device is charging, the Battery Status LED blinks to indicate charging status of the device.
6.1.2 Rocker Switch
The Rocker Switch enables the user to toggle between Standard Imaging Mode and Fluorescence Imaging Mode.
When the Rocker Switch is in its “down” position, MolecuLight i:Xis in Fluorescence Imaging Mode.
When the Rocker Switch is in its “up” position, MolecuLight i:Xis in Standard Imaging Mode.
To enable Standard Imaging Mode:
1.
Turn on the device (if it is not already on).
2.
Toggle the Rocker Switch to its “up” position
(Figure 5).
xMolecuLight i:Xis in Standard Imaging Mode.
To enable Fluorescence Imaging Mode:
1.
Toggle the Rocker Switch to its “down” position
(Figure 6).
x
MolecuLight i:Xis in Fluorescence Imaging Mode.
xViolet Wavelength LEDs turn on.
Figure 5:
Rocker Switch in Standard Imaging Mode (in ‘up’ position)
Figure 6:
Rocker Switch in Fluorescence Imaging Mode (in ‘down’ position)
7Quick Start Guide
Please see Appendix C for the MolecuLight i:XQuick Start Guide.
MolecuLight i:XTM User Manual Revision 1.1 Page 20 of 43
8Environmental Conditions That Affect Use
MolecuLight i:Xis intended to be used in a hospital/clinical setting.
Caution
MolecuLight i:Xis not suitable for use in the presence of flammable anesthetic mixtures with air,
oxygen or nitrous oxide.
8.1 Lighting
The level of ambient light in the imaging environment dramatically affects the quality of both the Standard Imaging Mode
and Fluorescence Imaging Mode images acquired with the MolecuLight i:XImaging Device. A green Ambient Light Status
LED indicates when the lighting conditions are optimal for imaging in Fluorescence Imaging Mode. During Standard Imaging
Mode the Ambient Light Status LED will be amber. Check the Ambient Light Status LED prior to toggling the Rocker Switch to
FL-Mode.
If you are unable to obtain optimal ambient light for Fluorescence Imaging Mode, MolecuLight recommends using
MolecuLight DarkDrape (used in conjunction with MolecuLight Adapter). For more information refer to Section 4.3.
Caution
Be aware of surroundings when using the MolecuLight i:Xin dark environments during
Fluorescence Imaging Mode. Failure may result in bodily injury due to tripping.
8.2 Operating Temperature
The device is designed to operate in environment temperatures between 10-30oC (50-86oF).
8.3 Storage
Store MolecuLight i:Xat room temperature in a secure location between uses.
Store the MolecuLight DarkDrape at room temperature in a dry place.
9Operating Instructions
9.1 Proper Imaging Technique
A standardized wound imaging protocol is critical to the accuracy and objectivity of digital wound evidence and image
capture. Images should be acquired while holding the device stable in the hands of the user and while the patient is not
moving (to avoid movement artifacts in the images). See Figure 7.
To capture images with MolecuLight i:X(in either Standard Imaging Mode or Fluorescence Imaging Mode):
xHold the device 8-12 cm away from the wound. The Range Finder LED is green when the distance between
MolecuLight i:Xand the wound is optimal.
xEnsure that the wound is centered in the camera’s field of view.
xHold MolecuLight i:Xsuch that the plane of the wound is parallel to the plane of MolecuLight i:X. See Figure 8.
Note
The optical glass windows (see Figure 7) must be clean for optimal Standard Imaging Mode and
Fluorescence Imaging Mode image capture
. Refer to Section 12 for information about cleaning
MolecuLight i:X.
Caution
Patient movement while the device is in close proximity to the patient may result in distorted images.
Caution
Angling the device incorrectly may result in poor image quality. The Illumination Zone on the device
should point directly at wound and be held at the recommended distance.
Failure
to do so may result
in poor image quality. Refer to Figure 8.