MolecuLight i:X User Manual
MolecuLight i:XTM User Manual
Trademarks
MolecuLightTM, MolecuLight i:XTM, MolecuLight DarkDrapeTM, MolecuLight AdapterTM, Standard Imaging ModeTM,
Fluorescence Imaging Mode
TM
, ST-imageTM, ST-videoTM, FL-imageTM, FL-videoTM are trademarks of MolecuLight, Inc.
Patent Information
The MolecuLight i:X Imaging 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:X and its accessories are designed and manufactured by MolecuLight Inc.
MolecuLight Inc.
425 University Ave., Suite 700
Toronto, Ontario, Canada
M5G 1T6
Telephone: +1-647-362-4684, or 1-877-818-4360 (North America Only)
Fax: 647-362-4730
Email: info@moleculight.com
www.moleculight.com
The European authorized representative for MolecuLight Inc. is Emergo.
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
MolecuLight i:X
TM
User Manual Revision 1.1 Page 2 of 43
Contents
1 INTRODUCTION ........................................................................................................................................................................ 5
2 WARNINGS, 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
3 CONTENTS .............................................................................................................................................................................. 11
3.1 MOLECULIGHT I:X SYSTEM CONTENTS ..................................................................................................................................................... 11
3.2 MOLECULIGHT I:X ACCESSORIES AND CONSUMABLES .................................................................................................................................. 11
4 MOLECULIGHT I:X IMAGING DEVICE OV ERVIEW ..................................................................................................................... 12
4.1 MOLECULIGHT I:X IMAGING DEVICE DESCRIPTION AND USE ......................................................................................................................... 12
4.2 HOW MOLECULIGHT I:X CREATES IMAGES IN FL-MODE .............................................................................................................................. 14
4.3 MOLECULIGHT DARKDRAPE AND MOLECULIGHT ADAPTER DEVICE DESCRIPTION AND USE ................................................................................. 15
5 INTENDED USE AND INDICATION FOR USE ............................................................................................................................. 15
5.1 OFF LABEL USE .................................................................................................................................................................................... 15
6 DEVICE 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
7 QUICK START GUIDE ............................................................................................................................................................... 19
8 ENVIRONMENTAL CONDITIONS THAT AFFEC T USE ................................................................................................................. 20
8.1 LIGHTING ............................................................................................................................................................................................ 20
8.2 OPERATING TEMPERATURE .................................................................................................................................................................... 20
8.3 STORAGE ............................................................................................................................................................................................ 20
9 OPERATING INSTRUCTIONS .................................................................................................................................................... 20
9.1 PROPER IMAGING TECHNIQUE ................................................................................................................................................................ 20
9.2 HANDLING MOLECULIGHT I:X ................................................................................................................................................................. 21
9.3 IMAGING WITH MOLECULIGHT I:X (IX CAMERA 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
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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 INTERPR ETATION 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 TROUBL ESHOOTING AND SUPPORT ....................................................................................................................................... 38
15.1 FREQUENTLY ASKED QUESTIONS ............................................................................................................................................................. 38
15.2 IX CAMERA APP TROUBLESHOOTING ........................................................................................................................................................ 41
16 WARRAN TY ............................................................................................................................................................................ 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 MEASUR EMENT QUICK START GUIDE
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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.
Messages with this heading provide additional information that increase the user’s understanding of
the operation of the device.
Warning
The use of an accessory or cable with the MolecuLight i:X Imaging Device other than those specified in
Section
3 may result in increased emissions or decreased immunity of the MolecuLight i:X Imaging
Device.
Warning
The MolecuLight i:X Imaging 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:X Imaging Device.
Warning
MolecuLight i:X is 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:X is not suitable for use in the presence of flammable anesthetic mixtures with air,
oxygen or nitrous oxide.
Warning
Protect MolecuLight i:X against 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 support@moleculight.com.
Warning
Do not soak or immerse MolecuLight i:X in water or other liquids.
Warning
Be aware of surroundings when operating MolecuLight i:X in 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
a
ntennas) 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:X could result.
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:X Imaging 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:X Imaging 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 46
0
C 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:X for download. Do not download any nonMolecuLight Apps in order to maintain the device configuration intended for use.
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.
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Imaging Device. The handheld MolecuLight i:X Imaging Device
2 Warnings, Cautions, and Notes
Please read the following safety information before using the MolecuLight i:X Imaging Dev ice.
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:
2.1.2 General Caution Messages
Note
2.1.1 General Warning Messages
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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
Symbol
Meaning
Dispose of the MolecuLight i:X in accordance with your country’s legal requirements for the disposal
of electrical and electronic waste
continuously on for 15 minutes in Fluorescence Imaging Mode, violet
CE Marking indicates European Conformity to essential requirements of applicable European
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)
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:
N/P: 1142
For further information related to accessories and consumables, refer
Contains FCC ID:BCG-A1421 and IC:579CA1421
In reference to iPod touch (part of the MolecuLight i:X, referred to as
the Display Screen)
Symbol
Source & Meaning
Symbol
Source & Meaning
Source: IEC 60417-5010
Meaning: Power Button
Source: MolecuLight symbol
Meaning: Ambient Light Status
Source
Meaning
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:X Charging Port
(D.C)
Source
: MolecuLight symbol
Meaning
: Home Button (for Display Screen)
Source: MolecuLight symbol
Meaning: Range Finder
Symbol
Source & Meaning
Symbol
Source & Meaning
Source: ISO 15223-1:2012
Meaning:
C
to 50
F) ambient
temperature
Source: WEEE symbol, EU Directive 2012/19/EU
Meaning:
accordance with your country’s legal requirements for
the disposal of electrical and electronic waste
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source: ISO 15223-1:2012
Meaning:
atmospheric pressure
Source:
Meaning:
Source:
Meaning:
Source:
Meaning
Source:
Meaning
2.1.3 Acronym Table
2.2 Symbols
2.2.1 Symbols Used on the MolecuLight ii:X Imaging Device Label
The following table lists the symbols and statements used on the MolecuLight i:X Imaging Device label (silver label).
Caution, consult accompanying documents
2.2.2 Symbols Used on MolecuLight ii:X
The following table lists the symbols used in the labeling of MolecuLight i:X.
: MolecuLight symbol
: Display Screen Power Button
Read User Manual
Date of manufacture
Catalog number
Serial number
Certification of safety testing
RF transmitter for wireless transmission
Device duty cycle (if device is
LEDs should be turned off for 5 minutes before Fluorescence Imaging Mode is accessed again)
product directives; 0123 represents MolecuLight Inc.’s Notified Body
The MolecuLight i:X Imaging Device
complies with Part 15 of the FCC Rules
1142. A utiliser uniquement avec Câble
Table 1: Symbols and statements on MolecuLight i:X Imaging Device label
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to Section 3
Table 2: MolecuLight i:X symbols
2.2.3 Symbols Used on MolecuLight i:X Packaging
The following table lists the symbols and statements used on the MolecuLight i:X packaging label and indicates storage and
transportation conditions.
o
o
Dispose of the MolecuLight i:X in
ISO 15223-1:2012
Maintain within 10% to 70% humidity
Maintain within 89 kPa to 102 kPa for
MolecuLight symbol
Do not stack or compress
ISO 15223-1:2012
: Keep dry
MolecuLight i:X
Maintain within -10
o
C (14oF to 122
ISO 15223-1:2012
Non sterile
ISO 15223-1:2012
Fragile
ISO 7000:2014
Face up
ISO 7000:2014
: Recyclable
Table 3: MolecuLight i:X transportation and storage conditions
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Symbol
Source & Meaning
Symbol
Source & Meaning
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source:
Meaning:
Source: European Conformity Marking
Meaning:
product meets the requirements of the applicable EC
directives
Symbol
Source & Meaning
Symbol
Source & Meaning
Source
: ISO 15223-1:2012
Meaning
: Catalog number
Source:
Meaning
Source
: ISO 15223-1:2012
Meaning:
Batch code
Source:
Meaning
Source:
ISO 15223-1:2012
Meaning
: Date of manufacture
Source:
Meaning
Source:
ISO 7010:2011
Meaning
: Read User Manual
Source:
Meaning
Source:
ISO 15223-1:2012
Meaning
: Fragile
Source:
Meaning
Source:
ISO 15223-1:2012
Meaning:
Caution, consult
accompanying documents
Source: European Conformity Marking
Meaning:
the product meets the requirements of the
applicable EC directives
Note
The emissions characteristics of the MolecuLight i:X make it suitable for use in industrial areas and
hospitals (CISPR 11 class A).
MolecuLight i:X is 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.
Caution
Do not point the laser (from the
2.2.4 Symbols Used for MolecuLight DarkDrape Label
The following table lists the symbols and statements used on the MolecuLight DarkDrape label.
ISO 15223-1:2012
Catalog number
ISO 15223-1:2012
Batch code
ISO 15223-1:2012
Date of manufacture
ISO 7010:2011
Read User Manual
ISO 15223-1:2012
Caution, consult
accompanying documents
Table 4: Symbols and statements on the MolecuLight DarkDrape label
ISO 15223-1:2012
Do not use if package is damaged
ISO 15223-1:2012
For single use only
ISO 15223-1:2012
Non sterile
IEC 60417 – 5840
Type B applied part
Manufacturer's declaration that the
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.
ISO 15223-1:2012
: Keep dry
ISO 15223-1:2012
: Do not use if package is damaged
ISO 15223-1:2012
: For single use only
ISO 15223-1:2012
: Non sterile
IEC 60417 – 5840
: Type B applied part
Manufacturer's declaration that
Table 5: Symbols and statements on the MolecuLight DarkDrape package label (10-pack and 50-pack)
2.3 Certifications
The MolecuLight i:X Imaging Device complies with the following standards:
x Safety 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
x Safety EMC Testing per IEC 60601-1-2:2014 4th Edition / EN 60601-1-2:2015
x Safety LED testing per IEC 60601-2-57:2011 and IEC 62471:2006 / EN 60601-2-57:2011 and EN 62471:2008
x Usability Testing per IEC 60601-1-6:2010+A1:2013 / EN 60601-1-6:2010 and EN 62366:2008
x Risk Management per ISO 14971:2007 / EN ISO 14971:2012
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x Quality 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:X has an operational duty cycle of 15 minutes on, 5 minutes off. The implication for this duty cycle is that if
the MolecuLight i:X is 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:X in Canada is Class II medical device and a Class IIa medical device in
Europe. Alone, the MolecuLight i:X does not require patient contact for use. The MolecuLight DarkDrape (used in
combination with the MolecuLight Adapter and MolecuLight i:X to 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:X is 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:X Imaging 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:X Imaging 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:X Imaging 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).
2.5 Information on Laser Radiation Output
The MolecuLight i:X Imaging 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
MolecuLight i:X
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User Manual Revision 1.1 Page 10 of 43
Range Finder sensor) into eyes (Figure 2, item 14).
# in
Figure 1
1
MolecuLight i:X Imaging Device
Device operates on Apple iOS software
MolecuLight Power Cable
Cable to charge the MolecuLight i:X Imaging 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:X use
4
User Manual
Provides detailed instructions on use of the MolecuLight i:X
Optical
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
Note
The MolecuLight DarkDrape and MolecuLight Adapter (Figure 1, items 7-8) are not part of the
MolecuLight i:X System configuration. They are optional accessories that may be ordered separately.
# in
Figure 1
MolecuLight
Part #
Reorder from MolecuLight
MolecuLight
Power Cable
Cable to charge the MolecuLight i:X Imaging
Device
computer; Includes geography
adaptors (where applicable)
3
Quick Start Guide
Step by step guide for MolecuLight i:X use
1295
Yes
User Manual
Provides detailed instructions on use of the
MolecuLight i:X
Optical Lens
Wipes
100)
Box of 100 optical lens cleaning towelettes,
individually packaged for cleaning
screen
and optical windows (ProWorks)
MolecuLight
WoundStickers
1 box of 2,000 stickers for wound area
measurement with the MolecuLight i:X
MolecuLight
Adapter
Reusable Adapter to connect MolecuLight
DarkDrape to the MolecuLight
optimal lighting environment for imaging wounds
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
eo
Lens Cleaning
Solution
Lens cleaning solution t
optical components
No; available from Edmund
Optics, Fisher Scientific,
VWR, Staples.com,
Amazon.com
Fisherbrand Lens
Paper (4’’x
Len paper t
components
No; available from Fisher
Scientific,
Staples.com, Amazon.com
CaviWipes
Disinfecting wipes to clean the device between
uses (Metrex)
No; available from Metrex,
K
Fisher Scientific
Warning
Do not connect the MolecuLight i:X Imaging 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
3 Contents
To reorder items available from MolecuLight, contact MolecuLight by email: info@moleculight.com.
Item Description
Figure 1: MolecuLight i:X Imaging Device and its components
3.1 MolecuLight ii:X System Contents
The MolecuLight i:X Imaging 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:X Imaging Device to be
used in a patient care setting.
Item Description
2
5
Lens Wipes
Table 6: List of items included with the MolecuLight i:X System (P/N 1153)
-
3.2 MolecuLight i:X Accessories and Consumables
MolecuLight i:X accessories and consumables are listed below in Table 7 along with suggested vendors from which the
items may be purchased (if not available from MolecuLight).
TM
MolecuLight i:X
User Manual Revision 1.1 Page 11 of 43
2
4
5
6
7
8
N/A
N/A
N/A
Detailed information about cleaning and disinfecting the MolecuLight i:X is provided in Section 12.
(Box of
TECHSPEC
6’’)
and download images/videos to a
-specific plug
display
i:X to create an
-
o clean the device’s
(Edmund Optics)
o clean the device device’s optical
(Fisher Scientific)
Table 7: List of recommended MolecuLight i:X accessories and consumables
1142 Yes
1294 Yes
1182 Yes
1266 Yes
1215 Yes
1212 Yes
N/A
N/A
N/A
VWR,
-Dental, Amazon.com,
Towelette.
4 MolecuLight ii:X Imaging Device Overview
4.1 MolecuLight i:X Imaging Device Description and Use
The MolecuLight i:X Imaging 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:X Imaging 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:X uses 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:X Imaging Device captures real-time images (JPEG format) and videos (MOV format) in Standard Imaging
TM
and Fluorescence Imaging ModeTM. These modes are identified as follows:
Mode
MolecuLight i:X
TM
User Manual Revision 1.1 Page 12 of 43
Note
Wound measurement is
only possible on an ST-Image (see Section 10).
Warning
Heat Sink
Note
Keep the Illumination Zone clean and avoid covering the Violet Wavelength LEDs and camera sensor
window with your fingers
Caution
The MolecuLight i:X Imaging Device is restricted to use by trained health care professionals and
should be protected from unauthorized use.
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
.
1. Standard Imaging Mode
In Standard Imaging Mode, MolecuLight i:X is able to capture the following images:
a. ST-image
b. ST-video
TM
(or ST-Mode): Real-time imaging as per standard photography.
TM
: An image captured in Standard Imaging Mode
TM
: A video captured in Standard Imaging Mode
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
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:X is able to capture the following images:
a. FL-image
b. FL-video
The device provides image-guidance during visual assessment of wounds.
The device can capture an ST-image
TM
: An image captured in Fluorescence Imaging Mode
TM
: A video captured in Fluorescence Imaging Mode
TM
, ST-videoTM, FL-imageTM, and FL-video
TM
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).
1. Power Button: pressing button turns the device ON/OFF
Figure 2: Clinician side, side views and Patient side of MolecuLight i:X Imaging Device
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
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
TM
MolecuLight i:X
User Manual Revision 1.1 Page 13 of 43
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:X Charging 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:
x Reading this User Manual in its entirety
x Following the Quick Start Guide (Appendix C) and the MolecuLight i:X Imaging Device Overview (Appendix B)
x Following the MolecuLight DarkDrape & MolecuLight Adapter Instructions for Use (Appendix D) and the MolecuLight i:X
Wound Measurement Quick Start Guide (Appendix E)
4.2 How MolecuLight ii:X Creates Images in FL-Mode
The MolecuLight i:X includes 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:X uses violet light illumination to create real-time fluorescence images.
Figure 3: MolecuLight i:X Real-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.
TM
MolecuLight i:X
User Manual Revision 1.1 Page 14 of 43
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.
Note
The Display Screen and the MolecuLight i:X Imaging Device each contain separate rechargeable
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.
Note
The ON/OFF state of the MolecuLight i:X is 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.
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.
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 for purposes of image or video
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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MolecuLight i:X
User Manual Revision 1.1 Page 15 of 43
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:
x Rocker Switch
x Two Power Buttons
x Four Status indicator LEDs (see Figure 4)
x 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:
x 4-inch (diagonal) widescreen display with Multi-Touch technology
x 1136-by-640-pixel resolution at 326 pixel per inch
x 800:1 contrast ratio (typical)
x 500 cd/m
x 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.
Figure 4: Schematic rendering of MolecuLight i:X Imaging Device showing 1- System Status LED, 2 - Battery Status LED 3- Range Finder
2
max brightness (typical)
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:
x OFF: the MolecuLight i:X is powered off
x ON: the MolecuLight i:X is powered on (Violet Wavelength LEDs turn on after Fluorescence Imaging Mode is
selected)
TM
MolecuLight i:X
User Manual Revision 1.1 Page 16 of 43
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