For Research Use Only. Not for use in diagnostic procedures.
iBright
™
Imaging Systems
USER GUIDE
For use with the iBright
™
CL1500 Imaging System and the iBright
™
FL1500
Imaging System
Catalog Numbers A44114 (CL1500) and A44115 (FL1500)
Publication Number MAN0018592
Revision D.0
Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
Revision history:Pub.No. MAN0018592
Revision Date Description
D.0 31 October 2022
•
Updating workflows according to instrument firmware upgrades.
•
Adding SmartRange
™
HDR functionality and analysis of E-gel and colony images in Universal
mode.
C.0 24 August 2020
Adding SAE chapter due to addition of SAE instrument functionality.
B.0 23 September 2019
•
Updated the components list (see Table 1 on page 6).
•
Updated the recommended excitation/emission wavelengths to image fluorescent Western blots
(see "Fluorescent Blots (FL1500 model only)" on page 14).
•
Updated the emission filters for the iBright
™
FL1500 Instrument (see Table 4 on page 18).
•
Added additional outputs for TPN-normalized data.
•
Added additional information for resetting factory defaults, backing up, and restoring settings (see
"Settings" on page 30).
A.0 7 June 2019
New document for iBright
™
Imaging Systems.
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE
LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR
ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Important Licensing Information: This product may be covered by one or more Limited Use Label Licenses. By use of this product,
you accept the terms and conditions of all applicable Limited Use Label Licenses.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2022 Thermo Fisher Scientific Inc. All rights reserved.
Contents
■
CHAPTER1Productinformation ................................................. 7
Productdescription ............................................................. 7
Contents ....................................................................... 7
■
CHAPTER2Start, sign on, and configure theinstrument ..................... 9
Create an instrumentprofile ...................................................... 9
Create an instrument account and link to Connect using a cloudaccount .............. 9
Mobiledevice ............................................................. 10
PC using Connectaccount ................................................. 10
PC using instrument Connectapp ........................................... 10
Link to Connect using an existing instrumentaccount .............................. 11
If the unit iso ................................................................. 11
If the unit is on and in sleepmode ................................................ 12
If the unit is on and in activemode ............................................... 12
■
CHAPTER3Operate the iBright
™
imager ...................................... 13
Choose imaging mode and start image capture .................................... 13
ChemiBlots ................................................................... 14
Image using ChemiBlots ................................................... 14
Fluorescent Blots (FL1500 modelonly) ............................................ 15
Image using FluorescentBlot ............................................... 15
Nucleic AcidGels .............................................................. 17
Image using Nucleic AcidGel ............................................... 17
ProteinGels ................................................................... 18
Image using ProteinGels ................................................... 18
UniversalMode ................................................................ 19
Options available inmodes ...................................................... 21
Image Gallery .................................................................. 24
Viewimages .............................................................. 24
iBright
™
Imaging Systems User Guide
3
■
CHAPTER4Export and analyzeimages ....................................... 25
Exportimages ................................................................. 25
Export newimages ........................................................ 25
Export galleryimages ...................................................... 25
Select an Export filetype ................................................... 26
Archive/Backup g2i imagefiles .............................................. 27
Analyzeimages ................................................................ 28
Analyze newimages ....................................................... 28
Analyze galleryimages ..................................................... 30
Analyze 96-well E‑Gel
™
images taken in Universal mode using the E‑Gel
™
96application ........................................................... 30
Analyze colony images taken in Universal mode using the Colony
Countapplication ........................................................ 31
■
CHAPTER5Maintain theinstrument ........................................... 33
Settings ....................................................................... 33
Manageaccounts .......................................................... 35
Run instrumentdiagnostics ..................................................... 36
Clean theinstrument ........................................................... 36
Replace the instrumentfuses .................................................... 37
Materials required .......................................................... 37
Replace thefuses .......................................................... 37
Move theinstrument ........................................................... 38
Prepare forshipping ....................................................... 38
■
CHAPTER6Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR
Part 11 Support ................................................................... 39
Security Audit e-Signature (SAE) for the iBright
™
Imager ............................ 39
Activate your license key ........................................................ 40
Enable SAEmode .............................................................. 40
Disable SAEmode ............................................................. 41
Sign in to the instrument inSAE mode ............................................ 41
Change your password in SAEmode ............................................. 42
SAE user roles ................................................................. 42
SAE privileges for default user roles .............................................. 43
Non-SAE user roles ............................................................ 43
Acquire images in SAEmode .................................................... 44
Contents
4
iBright
™
Imaging Systems User Guide
Use the Gallery in SAEmode .................................................... 44
Filestatus ................................................................ 44
Filter Gallery by filestatus .................................................. 44
Archive/Backup g2i image files in SAE mode ................................. 44
Commitchanges ............................................................... 45
Signdata ..................................................................... 46
Unlockfiles ................................................................... 46
Generate an audit history ....................................................... 47
View the e-Signature history ..................................................... 47
Export imagefiles .............................................................. 47
Generate and export Analysis Report ............................................. 48
■
APPENDIXAInstrumentspecifications ........................................ 49
Instrument dimensions andspecifications ......................................... 49
Electrical requirements ......................................................... 49
Environmental requirements ..................................................... 49
Network requirements .......................................................... 50
Instrument and computerconnections ............................................ 51
■
APPENDIXBSafety .............................................................. 53
Symbols on thisinstrument ..................................................... 53
Location of safety labels on theinstrument .................................... 55
Safety information for instruments not manufactured by Thermo FisherScientific ...... 55
Instrumentsafety .............................................................. 55
General ................................................................... 55
Physical injury ............................................................. 56
LED (Light-EmittingDiode) .................................................. 56
Electricalsafety ........................................................... 57
Cleaning anddecontamination .............................................. 58
Instrument component and accessorydisposal ................................ 58
Safety and electromagnetic compatibility (EMC) standards .......................... 59
Safetycompliance ......................................................... 59
EMC ..................................................................... 59
Environmentaldesign ...................................................... 60
Chemicalsafety ................................................................ 62
Biological hazardsafety ......................................................... 63
Contents
iBright
™
Imaging Systems User Guide
5
■
APPENDIXCDocumentation and support .................................... 64
Related documentation and references ........................................... 64
Customer and technical support ................................................. 65
Limited product warranty ........................................................ 65
Contents
6
iBright
™
Imaging Systems User Guide
Product information
IMPORTANT! Before using this product, read and understand the information in the “Safety”
appendix in this document.
Product description
The iBright
™
CL1500 Imaging System allows users to image chemiluminescent Western blots, DNA and
RNA gels stained with fluorescent nucleic acid stains, and visible protein gels. The iBright
™
FL1500
Imaging System adds the capability of imaging fluorescent Western blots using multiple dyes.
The iBright
™
imagers use a simple design and intuitive workflows to deliver high-resolution images.
They can be run directly from the touchscreen to start and create images, while also providing on-board
software for image analysis. To further analyze data, the instrument can be integrated with the iBright
™
Image Analysis Software available for desktop and Connect.
Contents
Table1Included imager system parts
Component
Quantity
iBright
™
Imaging System 1
Power cord (region specific) 1
Quick Reference Guide 1
Contrast tray 1
iBright
™
Imaging System Sample Blot 1
Sample stage/turntable 1
Product Information Sheet 1
Safe Imager
™
Viewing Glasses 1
1
iBright
™
Imaging Systems User Guide
7
Table2Available accessories
Component Part number
iBright
™
System Contrast Tray A56597
Sample stage A33829
High-Power USB Wi-Fi Module A26774
iBright
™
E‑Gel
™
Tray Adapter
A56600 (11/22)
A56599 (48/96)
Chapter1Product information
Contents
1
8
iBright
™
Imaging Systems User Guide
Start, sign on, and configure the
instrument
Create an instrument profile
1.
Touch
to sign in to your instrument user account.
2.
Touch Get started.
3.
Touch Create a Profile.
4.
Enter a Screen name.
5.
Enter and confirm a four-digit pin.
6.
Touch Create profile.
7.
(Optional) If you want to link your instrument to your Connect account, see “Link to Connect using
an existing instrument account” on page11.
Create an instrument account and link to Connect
using a cloud account
1.
Touch to sign in to your instrument user account.
2.
Touch Get Started.
3.
Click on Connect.
4.
Link your account using one of these methods:
•
Mobile device — Connect using a QR generated by the instrument and scanned by the
instrument Connect mobile app.
•
PC — Connect using a link code that is entered into the instrument Connect app or your
online Connect account.
•
Instrument — Enter your Connect account information directly on the instrument.
2
iBright
™
Imaging Systems User Guide
9
Mobile device
1.
Touch Mobile Device.
2.
Launch instrument Connect mobile app.
3.
Sign into your Connect account on the mobile app.
4.
Click on
.
5.
Click on QR code.
6.
Scan QR code on the instrument.
Your Connect account should now be linked to your instrument account.
PC using Connect account
1.
Touch PC.
2.
Login to your Connect account online.
3.
Click on
.
4.
Click on .
5.
Select iBright from the drop-down menu.
6.
Enter the linking code and click on Send.
Your Connect account should now be linked to your instrument account.
PC using instrument Connect app
1.
Touch PC.
2.
Launch the instrument Connect mobile app.
3.
Sign into your Connect account on the mobile app.
4.
Click on
.
5.
Click on Linking code.
6.
Enter the linking code and click Send.
Your Connect account should now be linked to your instrument account.
Chapter2Start, sign on, and configure the instrument
Create an instrument account and link to Connect using a cloud account
2
10
iBright
™
Imaging Systems User Guide
Link to Connect using an existing instrument account
Linking to Connect after account creation can only be done during the export process.
1.
Click on .
2.
Select an image.
3.
Click on Actions.
4.
Click on Export.
5.
Click on Choose destination.
6.
Click on Cloud.
7.
Click on Sign in.
8.
Connect using one of the methods outlined in “Create an instrument account and link to Connect
using a cloud account” on page9.
If the unit is o
1.
Ensure the unit is plugged in and turn on using the switch on the back of instrument.
The instrument will go directly to the sign-in page.
2.
Enter a Screen name.
3.
Enter and confirm a 4-digit pin.
Note: For those not logged on as a user (guest), acquired images are saved to a guest gallery.
The guest gallery is not private. Any logged in user can view and modify images residing in the
guest gallery.
4.
From the Welcome screen, choose the appropriate Mode from the drop-down menu, touch
and place sample in the center of the transilluminator glass.
5.
Touch to close drawer (do not physically push on the drawer). Instrument adjusts and displays a
live-view sample image in the viewport.
Chapter2Start, sign on, and configure the instrument
Link to Connect using an existing instrument account
2
iBright
™
Imaging Systems User Guide
11
If the unit is on and in sleep mode
1.
Touch the screen to wake.
2.
Touch
to sign in to use or set up a user profile. See “Create an instrument profile” on page9 for
instructions on how to create a user profile.
Note: For those not logged on as a user (guest), acquired images are saved to a guest gallery.
The guest gallery is not private. Any logged-in user or other guest user can view and modify
images residing in the guest gallery.
3.
Enter a Screen name.
4.
Enter and confirm a 4-digit pin.
5.
From the Welcome screen, choose the appropriate Mode from the drop-down menu, touch Open
Drawer, and place sample in the center of the transilluminator glass.
6.
Touch
to close drawer (do not physically push the drawer). Instrument adjusts and displays a
live-view sample image in the viewport.
If the unit is on and in active mode
1.
If not already signed in, touch to sign in or set up a new user profile. See “Create an instrument
profile” on page9 for instructions on how to create a user profile.
Note: For those not logged on as a user (guest), acquired images are saved to a guest
gallery. The guest gallery is not private. Any logged-in user can view and modify images
residing in the guest gallery.
2.
From the Welcome screen, choose the appropriate Mode from the drop-down menu, touch
and place sample in the center of the turntable glass.
3.
Touch to close drawer (do not physically push the drawer). Instrument adjusts and displays a
live-view sample image in the viewport.
Chapter2Start, sign on, and configure the instrument
If the unit is on and in sleep mode
2
12
iBright
™
Imaging Systems User Guide
Operate the iBright
™
imager
Choose imaging mode and start image capture
On the Welcome screen:
1.
Use the drop-down menu to select the desired mode.
•
Chemi Blots to image chemiluminescent substrates.
•
Fluorescent Blots to image fluorescent substrates.
•
Nucleic Acid Gels to image DNA and RNA gels.
•
Protein Gels to image visible and fluorescently stained protein gels.
•
Universal to image samples containing multiple readouts, such as chemiluminescence,
fluorescence and/or colorimetric stains. Image display is similar to Fluorescent Blots and
allows you to assign false color to any sample. Use Colony Count and E‑Gel
™
96 applications
to provide specialized workflows to ensure proper analysis for these applications.
2.
Touch
to open drawer.
3.
Place sample in the center of the viewing area.
4.
Touch
to close drawer.
Note: In Chemi, Fluorescent Blots, and Universal modes the live view is illuminated using the
white Epi-LED by default. To use the green transilluminator LED for illumination for live view and to
capture of the membrane layer, touch the box Use Trans Light on the live-view screen.
Instrument automatically aligns, zooms, focuses, and acquires a live-view sample image.
Note: If any manual adjustments are required for zoom or focus, touch More options4Camera and
choose the appropriate menu item.
•
To image in Chemi Blots mode, proceed to “Image using Chemi Blots” on page14.
•
To image in Fluorescent Blots mode, proceed to “Fluorescent Blots (FL1500 model only)” on
page15.
•
To image in Nucleic Acid Gels mode, proceed to “Image using Nucleic Acid Gel” on page17.
•
To image in Protein Gels mode, proceed to “Image using Protein Gels” on page18.
•
To image in Universal Mode, proceed to “Universal Mode” on page19.
3
iBright
™
Imaging Systems User Guide
13
Chemi Blots
Mode to image chemiluminescent Western blots.
Image using Chemi Blots
1.
Touch Smart Exposure.
The imager acquires a series of short exposures, then renders a preview image and recommends
an exposure time. This is not a real image.
2.
(Optional) Touch More options4Region of Interest. Region of Interest is for directing Smart
Exposure to a specific region of the sample. Select the area to use as a Smart Exposure focal
point.
3.
(Optional) Adjust the exposure time using the following methods:
•
Touch
or .
•
Finger swipe in the segmented dial.
•
Touch the dial center box to select a preset exposure time or touch Custom to manually input
a time.
The image preview updates in real-time.
4.
Touch Enter (for a custom manual input).
5.
(Optional) Touch Smart Range
™
HDR to capture a high dynamic range image.
HDR exposure time will display. Touch Capture to acquire the HDR image or uncheck Smart
Range
™
HDR to return to Smart Exposure.
Note: This feature is also available after image capture.
6.
(Optional) Touch
to lock the camera settings (exposure time and zoom) to acquire additional
images using the same settings.
Note: Once lock settings are applied, the sample auto-rotation feature will be disabled after the
drawer has opened and closed. This feature is also available after image capture.
7.
Touch Capture to acquire an image.
The captured image is displayed and automatically saves to the gallery.
8.
If the image is acceptable, touch Export, Gallery, or Analyze. If the image is not acceptable, touch
More options to optimize the image or touch Trash to remove the image, then return to step 2 to
adjust exposure conditions.
Chapter3Operate the iBright
™
imager
Chemi Blots
3
14
iBright
™
Imaging Systems User Guide
Fluorescent Blots (FL1500 model only)
Mode to image fluorescent Western blots using a single channel or up to 4 channels using excitation
wavelengths (FWHM) of approximately 455-485 nm, 515-545 nm, 608-632 nm, 610-660 nm, and
745-765 nm; approximate emission wavelengths (FWHM) 508-557 nm, 568-617 nm, 675-720 nm,
710-730 nm and 800-850 nm.
Image using Fluorescent Blot
1.
Touch Choose a dye to select from one to four dyes from the pre-populated list.
Alternatively, to add a dye that is not in the pre-populated list, touch Custom Dye at the bottom
left-hand corner of the screen. Select a custom dye that has previously been entered or enter the
information for a new dye: dye name, emission wavelength, excitation wavelength, and false color.
a.
To edit an existing dye, touch the dye name button. Touch Dye and change the assigned dye
to any other pre-populated dye in the fluorescent dye list. Dyes in the pre-populated dye list
are categorized by most recently used, name, and emission color.
b.
Touch False Color and change the false color assigned to that dye.
Note: Each dye is assigned a false color to be used in the composite overlay.
c.
To remove the assigned dye from the channel, touch Remove Dye at the bottom left-hand
corner of the screen. Touch Confirm.
2.
Touch Done.
3.
Touch Smart Exposure. Alternatively, for manual exposure, touch More options4Manual
Exposure. For manual exposures, click on the dye to add a time for each dye selected.
The imager will acquire a series of short exposures for each dye type selected. It will then render
preview images and a recommended exposure time for each channel. These are not real images.
4.
(Optional) Touch More options4Region of Interest. Region of Interest is for directing Smart
Exposure to a specific region of the sample. You can select dierent, same, or no region of interest
for each channel.
5.
To adjust or set a manual exposure time for any of the channels you are acquiring, select the
channel (dye) that you want to change:
•
Touch
or .
•
Finger swipe in the segmented dial.
•
Touch the dial center box to select a preset exposure time or touch Custom to manually input
a time.
The image preview updates in real-time.
Chapter3
Operate the iBright
™
imager
Fluorescent Blots (FL1500 model only)
3
iBright
™
Imaging Systems User Guide
15
6.
Touch Capture to acquire an image.
The captured image is displayed and automatically saves to the gallery.
7.
If the image is acceptable, touch Export, Gallery, or Analyze. If the image is not unacceptable,
touch More options to optimize the image or touch Trash to remove the image, then return to step
2 to adjust exposure conditions.
Chapter3Operate the iBright
™
imager
Fluorescent Blots (FL1500 model only)
3
16
iBright
™
Imaging Systems User Guide
Nucleic Acid Gels
Mode to image DNA and RNA gels stained with fluorescent nucleic acid stains such as Ethidium
Bromide, SYBR
™
Safe, SYBR
™
Green (I or II), SYBR
™
Gold and similar products. For imaging high-
throughput E‑Gel
™
96-well agarose gels, use the E‑Gel
™
96 specialty application in Universal mode.
Image using Nucleic Acid Gel
1.
Touch Smart Exposure. Alternatively, to set a manual exposure time, touch the center of the dial.
The imager acquires a series of short exposures and then renders a preview image and a
recommended exposure time. This is not a real image.
2.
(Optional) Touch More options4Region of Interest. Region of Interest is for directing Smart
Exposure to a specific region of the sample.
3.
To adjust or set a manual exposure time, select a method:
•
Touch
or within dial.
•
Finger swipe in the segmented dial.
•
Touch the dial center box to select a preset exposure time or touch Custom to manually input
a time.
The image preview will update in real-time.
4.
Touch Capture to acquire image with the indicated exposure time.
Captured image appears on screen and automatically saves to the gallery.
5.
If the image is acceptable, touch Export, Gallery or Analyze. If the image is not acceptable, touch
More options4Image adjust to optimize the image or touch Trash to remove the image, then
return to step 2 to adjust exposure conditions.
Chapter3Operate the iBright
™
imager
Nucleic Acid Gels
3
iBright
™
Imaging Systems User Guide
17
Protein Gels
•
Protein Gels Visible: USE THE WHITE SCREEN OR CONTRAST TRAY BETWEEN THE SAMPLE
AND TRANSILLUMINATOR GLASS for samples including Coomassie-stained protein gels and
silver-stained protein gels.
•
Protein Gels Fluorescent: PLACE SAMPLE DIRECTLY ON THE TRANSILLUMINATOR GLASS for
samples including No-Stain
™
-labeled protein gels and SYPRO
™
dye-stained protein gels.
Image using Protein Gels
1.
Select whether you are imaging a visible sample (Protein Visible) or fluorescent sample (Protein
Fluorescent).
2.
An auto-zoomed and focused Live View of the image is now displayed in the viewport.
IMPORTANT! For visual stained protein on nitrocellulose and PVDF membrane, use Universal
Mode4Visible channel without the white screen.
3.
Touch Smart Exposure. Alternatively, to set a manual exposure time, touch the center of the dial.
The imager acquires a series of short exposures and then renders a preview image and a
recommended exposure time. This is not a real image.
4.
(Optional) Touch More options4Region of Interest. Region of Interest is for directing Smart
Exposure to a specific region of the sample. You can select dierent, same, or no region of interest
for each channel.
5.
To adjust or set a manual exposure time, select a method:
•
Touch or within dial.
•
Finger swipe in the segmented dial.
•
Touch the dial center box to select a preset exposure time or touch Custom to manually input
a time.
The image preview will update in real-time.
6.
Touch Capture to acquire image with the indicated exposure time.
Captured image appears on screen and automatically saves to the gallery.
7.
If the image is acceptable, touch Export, Gallery or Analyze. If the image is not acceptable, touch
More options4Image adjust to optimize image or touch Trash to remove image, then return to
step 2 to adjust exposure conditions.
Chapter3Operate the iBright
™
imager
Protein Gels
3
18
iBright
™
Imaging Systems User Guide
Universal Mode
Mode to image samples containing one or more signal types (chemi, fluor, and/or visible).
Table3Illumination sources, excitation filters, and emission filters for the iBright
™
CL1500
Instrument.
Illumination Excitation Filters Emission Filters
White Epi-LED 455-485 nm
400-700 nm
568-617 nm
ND filter
[1]
400-700 nm
Green trans 490-520 nm
[1]
Neutral density filter decreases the intensity of the white Epi-LED for visible imaging.
Table4Illumination sources, excitation filters, and emission filters for the iBright
™
FL1500
Instrument.
Illumination
Excitation Filters Emission Filters
White Epi-LED
455-485 nm
400-700 nm
508-557 nm
568-617 nm
675-720 nm
710-730 nm
800-850 nm
515-545 nm
608-632 nm
610-660 nm
nIR Epi-LED 745-765 nm
ND filter 400-700 nm
Green trans 490-520 nm
1.
Touch Choose Channel to select from one to four dierent dyes or stains from the pre-populated
list.
Alternatively, to add a dye that is not in the pre-populated list, touch Custom Dye at the bottom
left hand corner of the screen. Select a custom dye that has previously been entered or enter the
information for a new dye: dye name, emission wavelength, excitation wavelength, and false color.
a.
To edit an existing dye, touch the dye name button. Touch Dye and change the assigned dye
to any other pre-populated dye in the fluorescent dye list. Dyes in the pre-populated dye list
are categorized by most recently used, name, and emission color.
b.
Touch False Color and change the false color assigned to that dye.
Note: Each dye is assigned a false color to be used in the composite overlay.
c.
To remove this assigned dye from the channel, touch Remove Dye at the bottom left hand
corner of the screen. Touch Confirm.
Chapter3
Operate the iBright
™
imager
Universal Mode
3
iBright
™
Imaging Systems User Guide
19
Channel refers to the type of signal you want to capture and the imaging conditions you want to
use.
•
Chemi: Channel for measuring chemiluminescent signals.
•
Fluor [Epi-LED]: Channel for measuring fluorescent signals that are excited using the
appropriate Epi-LED/excitation filter combination and the appropriate emission filter.
•
Fluor [Trans]: Channel for measuring fluorescent signals that are excited by the green
transilluminator and appropriate emission filter.
•
Nucleic acid: Channel for measuring fluorescent signals in gel that are excited by the green
transilluminator and the 568-617 emission filter (stained DNA and RNA).
•
Protein: Channel for measuring fluorescent and visible signals in gel that are excited or
illuminated by the green transilluminator and the 568-617 emission filter — stained or labeled
protein.
•
Visible: Channel for measuring visible signals on an opaque media (nitrocellulose membrane,
PVDF membrane, etc.) using the Epi-white LED with neutral density filter and appropriate
emission filter.
•
TPN: Total protein normalization channel is for normalizing Western blot results to total protein
load by lane.
•
E‑Gel
™
96: Channel for measuring fluorescent signals in high throughput E‑Gel
™
96 excited
by the green transilluminator and the 568-617 nm emission filter. Choosing this channel also
allows for an analysis workflow with deconvolution of image and data.
•
Colony Count: Channel for imaging bacterial petri dishes and cell culture plates using
dierent fluorescent filters, trans illumination, and Epi-white LEDs. Choosing this channel also
allows for a specialized colony analysis workflow.
2.
Touch Smart Exposure. Alternatively, for manual exposure, touch More options4Manual
Exposure. The imager will acquire a series of short exposures for each dye type selected. It will
then render preview images and a recommended exposure time for each channel. These are not
real images.
3.
(Optional) Touch More options4Region of Interest. Region of Interest is for directing Smart
Exposure to a specific region of the sample.
4.
To adjust or set a manual exposure time for any of the channels that you are acquiring, select the
channel (dye) that you want to change:
•
Touch or within dial.
•
Finger swipe in the segmented dial.
•
Touch the dial center box to select a preset exposure time or touch Custom to manually input
a time.
Note: When recommended exposure time is adjusted, the image preview will update in real time.
Chapter3
Operate the iBright
™
imager
Universal Mode
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Imaging Systems User Guide
5.
Touch Capture to acquire all of the selected channels with the indicated exposure times. Captured
image(s) appears in viewport and automatically saves to the gallery.
6.
If the image is acceptable, touch Export, Gallery, or Analyze. If the image is not acceptable, touch
More options4Image adjust to optimize image or touch Trash to remove the image, then return
to steps 3-5 to adjust exposure conditions.
Options available in modes
Each mode oers More Options on certain workflow screens to provide detailed camera and image
adjustment.
Table5Camera
Sub option
Detail
Resolution/Sensitivity
Changes binning setting to increase resolution/decrease sensitivity or
decrease resolution/increase sensitivity.
Zoom/Focus
Changes zoom level to increase or decrease image area. Focus is
automatically adjusted based on zoom. Auto focus can be used to
optimize sharpness.
Note: Optical zoom 1X to 2X and digital zoom 2X to 8X.
Sample rotation
Imager mechanically rotates sample ±10° depending on orientation.
Rotation is automatic, but also allows ability to adjust in More
Options4Camera Settings.
Table6Routines
Sub option
Detail
Multi-exposure
Series of 5 preset exposure times producing one image for each time
period.
Signal accumulation
Series of exposures where user defines the first capture (time), the last
capture (cumulative capture time) and the total number of captures.
Note: Images acquired using Signal Accumulation are not
recommended for publication or analysis. This feature is recommended
for determining an optimal exposure time.
Chapter3Operate the iBright
™
imager
Options available in modes
3
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™
Imaging Systems User Guide
21
Table7Image adjust
Sub option Detail
Contrast
Grayscale dierentiation between image features. Can use Auto
contrast (high, medium, low) or view raw image with no contrast.
User can manually adjust Gamma, White, Black using slider bars.
Channels and Layers
Allow user to navigate between individual channels associated with
a multi-channel image; pertains only to Chemi Blot, Fluorescent Blot,
and Universal modes (e.g., Channels: membrane, Alexa Fluor
™
488,
Alexa Fluor
™
555, Composite). Layers allow toggling on and o dierent
channels.
Zoom
For the CL1000, CL1500, FL1000, and FL1500 instruments, zoom
increases or decreases the optical (2X) and digital zoom (4X) up to a
total 8X zoom.
Invert
Produces a negative or positive (white to black or black to white) of the
displayed image.
Saturation
False colors saturated white pixels (65,536) as red to dierentiate from
non-saturated pixels.
Table8Other options
Sub option
Detail
Region of Interest
Specify an area on the image to determine the optimal exposure time
for that region using the Smart Exposure tool.
Manual exposure Manually select an exposure time for sample.
Smart Exposure
Predicts optimal exposure for minimizing pixel saturation and
maximizing dynamic range for a specific sample. Renders a preview
of how the image will appear at the recommended exposure time.
Smart Range
™
HDR
The Smart Range
™
HDR algorithm mathematically combines a short
and long exposure together into a single image that contains both
high and low signal intensities that fall within the linear dynamic range.
The new image maintains 16-bit resolution with lower noise and higher
linear dynamic range.
Band excision (Nucleic Acid
Gels mode)
Opens drawer and turns on green transilluminator to allow for safe band
excision on nucleic acid gels.
Membrane overlay (Chemi
blots, Fluorescent blots, and
Universal Mode)
Allows visible membrane overlay to see any visible prestained markers,
which aid in identifying molecular weights for unknown samples.
Chapter3Operate the iBright
™
imager
Options available in modes
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Imaging Systems User Guide
Table8Other options(continued)
Sub option Detail
2UP view (Fluorescent Blot
mode)
After a Smart Exposure or Capture, images are displayed by default
in a 2UP view.
•
Top image displays individual channels in grayscale. Switch
between individual channels by touching the channel you want
to display and edit. After a dye is selected, that channel image is
displayed in the top view and becomes editable so the user can
increase or decrease the exposure time dial and see in real time
the eect on the image preview.
•
Bottom image displays the color composite with channels
displayed as dierent false colors overlaid on a black background.
Individual channels can be toggled on and o in the composite
image by touching
at the left of the appropriate channel name.
•
For the Visible channel color composite, the signal is false‑colored
overlaid on a white background. Example: This channel is used to
display Coomassie‑stained protein gels.
1UP view (Fluorescent Blot
mode)
After a Smart Exposure or Capture, images can also be displayed in
a 1UP view.
Image displays the grayscale and false-color composite images by
toggling Gray or Color. User can switch between Individual channels
by touching the dye name you want to display. Individual channels can
be toggled on and o in the composite image by touching
on the
left of the appropriate dye name.
Note: Functionality for toggling between individual channels in
grayscale view or toggling on and o individual channels in the false-
color composite view is identical to the 2UP view.
Auto Enhance
Applies rolling-ball correction to the composite image of a multichannel
image. It can be toggled on and o and only aects the visible image,
not the raw data.
Camera lock settings
Allows user to lock the camera settings to take additional images with
the same parameters.
Chapter3Operate the iBright
™
imager
Options available in modes
3
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™
Imaging Systems User Guide
23
Image Gallery
The Image Gallery is an on-board storage location where your image files are kept for future viewing.
In the gallery you can easily retrieve, analyze, and manage your image files. Any image acquired on the
imager is automatically saved into a user's individual image gallery. For those not logged on as a user
(guest), acquired images are saved to a common gallery that houses all guest image files.
View images
On the Welcome screen or mode drop-down menu:
1.
Touch Gallery or .
2.
Toggle between Thumbnail view and List view to see stored images as thumbnails or a table.
Click the column headers to sort the images.
3.
Touch an image to select it. Touch again to deselect images. To choose all stored images, touch
Select all. Unselect using Deselect all.
4.
To filter images, touch Filter options and enter the search criteria. Touch Done.
5.
To select all of the images captured on a selected date, check the box on the left side for the
appropriate date.
Chapter3Operate the iBright
™
imager
Image Gallery
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Imaging Systems User Guide
Export and analyze images
Export images
Export new images
From the "Welcome" screen:
1.
Capture an image. See “Choose imaging mode and start image capture” on page13.
2.
Touch Export.
3.
(Optional) Touch Edit to enter a new file name or comments. Touch Save.
4.
Choose a Destination.
•
Connect
•
USB Drive
•
Network Drive
•
Network Printer
Note: The instrument requires a path for connection to a network drive or printer. Consult your
IT department for questions regarding your network. The following information may be required to
map a network drive:
·
Drive location: Enter the IP address, server name and file pathway (use forward slashes).
Example: 192.168.1.100/shared/R&D Data/John_Smith/2016
·
Additional information: Enter the domain name, username, and password.
5.
Choose a file type for export. See “Select an Export file type” on page26.
Export gallery images
1.
In the Gallery, select the desired image/images. See “View images” on page24 .
2.
Touch Actions.
3.
Touch Export.
4.
(Optional) Touch Edit to enter a new file name or comments. Touch Save.
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25
5.
Choose a Destination.
•
Connect
•
USB
•
Network Drive
•
Print
Note: The instrument requires a path for connection to a network drive or printer. Consult your
IT department for questions regarding your network. The following information may be required to
map a network drive:
·
Drive location: Enter the IP address, server name and file pathway (use forward slashes).
Example: 192.168.1.100/shared/R&D Data/John_Smith/2016
·
Additional information: Enter the domain name, username, and password.
6.
Choose a file type for export. See “Select an Export file type” on page26.
Select an Export file type
When exporting images, select an appropriate file type for your application. From the Export images
screen:
1.
Touch Choose File Type.
2.
Touch a file type.
File type Description
Publication - Exports 24-bit color-adjusted images for data sharing and presentation
TIFF Best quality
JPEG Medium quality
PNG Medium quality
Analysis - Exports 16-bit black and white, non-adjusted images for external image analysis
and processing
TIFF Best quality
G2i (iBright
™
proprietary file type for iBright
™
Analysis Software -
available on desktop and Connect)
Best quality
Note: Publication file types allow you to export composite and all channels as separate image
files. Touch the checkbox at the bottom of the screen to choose this option. If unchecked, then
only the false-color composite image will be exported.
3.
Touch Next.
Chapter4
Export and analyze images
Export images
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Imaging Systems User Guide
Archive/Backup g2i image files
All iBright
™
system users have an individual gallery for viewing and managing their own image files.
iBright
™
administrators can manage all user galleries simultaneously or individually.
1.
Touch Gallery.
Note: You can view the image files in the Gallery as thumbnails or a list. In list view, the user can
sort by file name, imaging mode, file size (kB), or acquisition date.
2.
Touch Filter options.
Note: Galleries can be filtered by keyword, date, imaging mode, and exposure mode (normal and
HDR).
3.
(Optional) Check the box Include guest's images to include the guest gallery.
4.
Check the Images box for all users to view images from all user galleries.
5.
(Optional) Check the Images for all users box, touch Enter ID, and choose the desired username
of the individual gallery that you want to manage.
6.
Touch Done. In the filtered Gallery, select the desired image file(s) or touch Select All to select all
image files in the Gallery.
7.
Touch Export to archive/backup the selected g2i file(s) or touch
to delete.
IMPORTANT! If an excessive number of files are selected, touching Actions is not
recommended. This may result in long wait times or possibly a system crash. Wait time is directly
proportional to the number of and total size of the selected image files.
Note: Action in the Gallery is intended for viewing image information, image adjustments, image
analysis, file renaming, and file export with no more than 50 image files in the tray. Bulk export and
delete should be done in the main Gallery using Export or Delete, respectively.
Chapter4Export and analyze images
Export images
4
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™
Imaging Systems User Guide
27
Analyze images
Analyze new images
1.
Capture an image. See “Choose imaging mode and start image capture” on page13.
2.
With the desired image open, touch Analyze.
The system automatically finds and displays analysis frames, lanes, and bands for the selected
image file. Multi-channel images are displayed as individual channels that can be toggled or
swiped between using the touchscreen. The system can identify 1-4 dierent analysis frames.
3.
(Optional) Touch the Sensitivity dial to raise or lower the band display threshold to increase or
decrease the number of bands displayed in each analysis frame.
4.
(Optional) Touch Edit analysis frame to remove, add or edit existing analysis frames.
5.
(Optional for fluorescent images) Touch the dye drop-down menu to select a particular dye or the
membrane view.
6.
(Optional) Touch More options to access image adjustments or to generate a report.
Image adjustments Functions
Adjust lanes Add, remove, or edit lanes.
Adjust bands Add, remove, or edit bands.
Add markers
Identify a molecular weight lane for each analysis frame. A known
standard can be used to approximate the molecular weight of unknown
bands.
Adjust image
Images are by default displayed auto-contrasted (medium). User can
change the auto-contrast to high or low setting or manually set black,
white and gamma using the appropriate slider bar.
Normalization
Total Protein Normalization (TPN) uses a total protein label or stain to
detect and quantify the total lane protein in a gel or on a membrane.
Western blot targets are normalized to total protein to correct for
loading and transfer anomalies. Alternatively, a housekeeping protein
can be immuno-detected and quantified to approximate protein load for
the same purpose.
Generate report
Prepare a pdf report displaying the images and analysis table
associated with the image file. Prior to generation of the report, select
the desired data to be included in the analysis table and edit the report
name if needed. This file can be exported and/or printed.
After each image adjustment:
a.
Touch Apply to accept the changes.
Chapter4
Export and analyze images
Analyze images
4
28
iBright
™
Imaging Systems User Guide
b.
(Optional) Touch Next to display the analysis table. At the top of the table, touch to change
the table output by:
Output Units Description (Lane and Band Table)
Volume Intensity Sum of pixel intensities contained in an identified band.
Weight kDa
Molecular weight estimated for an unknown sample
based on the sample's relative mobility in the gel
versus the molecular weight and relative mobility of
known standards.
Density Intensity/Area
Average intensity for all pixels contained in an identified
band (Volume divided by Area).
Local Background
Corrected Volume
Intensity
Volume minus the local background intensity (2-pixel
area surrounding the identified band region).
Local Background
Corrected Density
Intensity/Area
Local Background Corrected Volume divided by the
Area.
Migration Distance R
f
Distance migrated divided by the gel length.
Band Purity % percent
Divide the background-corrected band volume
(intensity) by the sum of all background-corrected band
volume (intensities) in the lane and multiply by 100.
Lane Purity
[1]
% percent
Divide the background-corrected band volume
(intensity) by the background-corrected total lane
volume (intensity) and multiply by 100.
[1]
This output is only available in the report.
c.
For TPN–normalized data, the lane and band table has the following additional outputs:
Output Units Description (Lane and Band Table)
Total Lane Volume Intensity Sum of pixel intensities contained in an identified lane.
Background Volume
(RB)
Intensity
Background determined using Rolling Ball Background
Correction.
Adjusted Total Lane
Volume
Intensity Total Lane Volume minus background volume.
Normalization Factor —
Normalization factors are proportional to the total lane
protein signal with a reference lane nominally set to
1.000.
Area (band)
[1]
Pixels
Total number of pixels contained within an identified
band.
Normalized
Corrected (band)
Volume
[1]
Intensity
Adjusted Total (band) Volume divided by the
Normalization Factor of the lane.
[1]
This output is available in the report only.
Chapter4
Export and analyze images
Analyze images
4
iBright
™
Imaging Systems User Guide
29
Analyze gallery images
On the "Welcome" screen or capture screen Mode drop-down menu:
1.
Touch Gallery or . Select one or multiple images.
2.
Touch Actions.
3.
If more than one image was initially selected, then choose one of the images within the scrollbar. If
needed, edit, remove, or delete the selected image.
4.
Touch Analyze.
The system automatically finds and displays analysis frames, lanes, and bands for the selected
image file. Multi-channel images are displayed as individual channels that can be toggled or
swiped between using the touchscreen. The system can identify 1-4 dierent analysis frames.
5.
(Optional) Touch the Sensitivity dial to raise or lower the band display threshold to increase or
decrease the number of bands displayed in each analysis frame.
6.
(Optional) Touch Edit analysis frame to remove, add or edit existing analysis frames.
7.
Touch Apply to accept any changes.
8.
(Optional) Touch More options to adjust lanes or bands, add markers, access image adjustments,
perform total protein normalization, or generate a report. For details, see “Analyze new images” on
page28.
For details on TPN normalized data outputs and TPN normalization channel lane outputs, see
“Analyze new images” on page28.
9.
(Optional) To generate a report, touch Generate report. Select data to include in the report and
edit the report name if desired. Press Enter. Touch OK.
10.
Touch Export.
11.
Select a destination and touch Done.
Analysis data is exported as a .csv file along with the report as a .pdf file.
Analyze 96-well E‑Gel
™
images taken in Universal mode using the
E‑Gel
™
96 application
1.
Open the desired 96-well E‑Gel
™
from the gallery or viewport. Touch Analyze.
The system automatically finds and displays the analysis frame and well template for the selected
image file. Lanes and bands are automatically detected after acquiring the frames and wells.
2.
Touch Edit analysis frame to remove, add, or resize existing analysis frames.
3.
Touch Apply to save changes. The system will run the well detection algorithm.
4.
(Optional) If needed for improved analysis, touch Reanalyze.
5.
Touch Next to analyze sample.
Chapter4
Export and analyze images
Analyze images
4
30
iBright
™
Imaging Systems User Guide
6.
Touch More options to add, remove, or edit lanes and/or bands.
Image adjustments Functions
Adjust lanes Add, remove, or edit lanes.
Adjust bands Add, remove, or edit bands.
Adjust image
Images are by default displayed auto-contrasted
(medium). User can change the auto-contrast to
high or low setting or manually set black, white
and gamma using the appropriate slider bar.
Deconvolute
Simplify viewing of the image by separating
individual samples into individual images.
Generate report
Prepare a pdf report displaying the images and
analysis table associated with the image file. Prior
to generation of the report, select the desired data
to be included in the analysis table. This file can
be exported and/or printed.
7.
Touch Apply to save changes.
8.
(Optional) To generate a report, touch Generate report. Select data to include in the report and
edit the report name if desired. Press Enter. Touch OK.
9.
Touch Export.
10.
Select a destination and touch Done.
Analysis data is exported as a .csv file along with the report as a .pdf file.
Analyze colony images taken in Universal mode using the Colony
Count application
1.
With the desired image open, touch Analyze.
The system automatically finds and displays wells and colonies for the selected image file.
2.
Touch Edit analysis well to add wells, remove wells, adjust well size, and adjust well shape.
3.
Touch Apply to save changes.
4.
Touch Adjust gating to change the colonies displayed based on area, brightness, and circularity.
5.
Touch the well to be adjusted, then change the specific parameters.
6.
Touch Done to save changes.
7.
Select the proper channel and background based on the image.
8.
Touch Next to analyze sample.
Chapter4
Export and analyze images
Analyze images
4
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™
Imaging Systems User Guide
31
9.
Touch More options to adjust colonies and image.
Image adjustments Functions
Adjust colonies Move and resize colonies.
Adjust image Adjust contrast, channels, and layers.
10.
(Optional) To generate a report, touch Generate report. Select data to include in the report and
edit the report name if desired. Press Enter. Touch OK.
11.
Touch Export.
12.
Select a destination and touch Done.
Analysis data is exported as a .csv file along with the report as a .pdf file.
Chapter4Export and analyze images
Analyze images
4
32
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™
Imaging Systems User Guide
Maintain the instrument
Settings
Access Settings
from the Home screen.
Instrument Settings
About Instrument
Provides all instrument details including serial number and firmware
version.
Date and Time Select a Time Zone, Date Format, and Time Format for your region.
Sleep Mode Enable or disable a sleep mode by toggling the button.
Manage Users
Security
mode
O = Guest users allowed. On = Login required for all
users.
Manage
accounts
See “Manage accounts” on page35.
Instrument Name Customize the instrument name.
Language Select a display language (subject to availability).
Reset User Tips Reset user tips for the logged-in guest.
Reset Factory Defaults
Note: Selecting this reset erases all user data and gallery
files.
Resets instrument to factory settings and clears out existing user
information. The instrument must be powered o, then powered on
to apply the change.
After resetting factory defaults, perform the new instrument set‑up
tasks. See Chapter 2, “Start, sign on, and configure the instrument”.
Backup and Restore
Backup Systems Settings and restore settings.
Note: This does not back up image files.
To enable or disable automatic file backup, see "Network Drive" in the
"Network Configuration" section (below).
File Naming Convention
User sets preference for file naming by selecting up to 3 of the following aspects: Mode, Binning, Custom
Field User, Exposure Time, and Sequential Number. Date and Time are mandatory aspects. The
aspects can be ordered by choice.
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33
Error Log
Displays instrument error history with sortable columns for Date, User, and Error Description. The Error
Log is exportable.
Event Log
Displays instrument error history with sortable columns for Date, User, Event Type, and Cloud Status.
Software Update
Updates the instrument software package by downloading via USB dongle or connection to the cloud.
Note: Cloud option requires a connection to your Connect account.
Network Configuration
Wired Searches for an ethernet connection.
Wireless
Searches for a wireless connection. Requires a USB wireless adapter
(High-Power USB Wi-Fi Module, Cat. No. A26774).
Network Drive
•
Enter a Drive location for connection. If needed, enter a Domain
name, Username, and Password.
•
Toggle the button to enable or disable automatic g2i file export
and backup upon logout.
Printer Configuration
Enter an IP address and choose between US Letter or A4 paper
size.
Cloud Region
Select the cloud region associated with your location: China if you are
located in China and Other if you are located anywhere other than
China.
Capture History
Displays image capture history with sortable columns for Date, User, Capture Mode, Image Name, and
Capture Status.
Chapter5Maintain the instrument
Settings
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Service Tools
Instrument Diagnostic
Runs diagnostic testing on the instrument hardware. Provides an end
report showing the functional status of hardware items.
Note: Running diagnostics is not required. Contact a service
technician for any issues.
Ship Prep Mode
Allows removal of the turntable for shipping.
Note: Instrument can only be powered o once turntable is removed.
Pixel Mapping
Pixel mapping is used to identify camera-specific pixel intensity
dierences that occur in long exposures and applies a correction for
any pixel that deviates from the normal dark value.
Manage accounts
Manage accounts allows for editing of user types and PINs and deleting profiles.
1.
Touch and log in to your user account. Once you log in, you are automatically taken to the
Welcome screen.
Note: You must be an Admin logged into your profile to manage accounts.
2.
Touch
, then click All Accounts.
•
All current user profiles will display.
•
Columns for Users, Created (date), User Type, and Account Type are sortable.
3.
Select the user whose account you want to manage.
4.
Select Manage on the bottom left side of the screen. Change a standard user to an Admin user by
sliding the button to Admin.
Note: You cannot change an Admin user to a standard user.
5.
Delete PIN — If a standard user forgets their PIN number, then you can delete their PIN so they
are prompted to create a new PIN the next time they log on.
6.
Delete Account — If you delete a user's account, you will also delete all of the image files in their
gallery.
Chapter5Maintain the instrument
Settings
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™
Imaging Systems User Guide
35
Run instrument diagnostics
Instrument functions can be checked by a user to confirm proper hardware operating conditions.
1.
Touch .
2.
Touch Service Tools.
3.
Touch Instrument diagnostic.
4.
Touch Start test.
The instrument will check the instrument hardware for correct operation and settings. The test will
take ~10 minutes to complete. The results of the test will display once complete. Detailed results
can be exported for further review.
Note: Ensure the drawer is not blocked. The drawer will open as part of the testing. (Not
applicable to iBright
™
CL750 model.)
Clean the instrument
Repeated instrument use can cause spots and smudges on the sample stage, which can then decrease
image quality. Clean the sample stage as needed.
Materials required
•
Safety glasses
•
Powder-free gloves
•
Tissue, lint-free
•
Deionized water
•
Ethanol, 70% solution
Note: Avoid the use of detergents.
1.
Open the drawer to expose the sample stage.
2.
Lightly spray the glass surface with deionized water or a 70% ethanol solution.
3.
Wipe the surface with a lint-free tissue until suciently clean.
4.
Close the drawer and operate the instrument as normal.
Chapter5Maintain the instrument
Run instrument diagnostics
5
36
iBright
™
Imaging Systems User Guide
Replace the instrument fuses
Materials required
•
Fuses, 1.6A, Time-Lag T, 250VAC, 5 × 20-mm (2)
•
Safety glasses
•
Powder-free gloves
•
Screwdriver, flathead
Replace the fuses
CAUTION! FIRE HAZARD. For continued protection against the risk of fire, replace fuses only with
listed and certified fuses of the same type and rating as those currently in the iBright
™
imager.
1.
Power o, then unplug the iBright
™
imager.
2.
Using a flat-head screwdriver, pry open the fuse door, and remove the fuse holder.
3.
Remove each fuse from its fuse holder and inspect it for damage. Carbon typically coats the inside
of failed fuses.
4.
Replace each failed fuse with a 1.6A, Time-Lag T, 250VAC, 5 × 20-mm Fuse.
Note: The voltage and amperage ratings are on the fuse holder.
5.
Install the fuse holder.
6.
Plug in, then power on the iBright
™
imager. The installation is successful if the instrument powers
on.
Chapter5
Maintain the instrument
Replace the instrument fuses
5
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™
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37
Note: Fuse failure can result from fluctuations in the supplied power to the iBright
™
imager. To prevent
further failures, consider installing an electrical protective device, such as a UPS or surge protector.
Move the instrument
CAUTION! PHYSICAL INJURY HAZARD. Do not attempt to lift the instrument or any other heavy
objects unless you have received related training. Incorrect lifting can cause painful and sometimes
permanent back injury. Use proper lifting techniques when lifting or moving the instrument. At least
two people are required to lift it.
IMPORTANT! Moving your instrument can create subtle changes in the alignment of the instrument
optics. Recalibrate the instrument if necessary.
•
Ensure that the surface on which you place the instrument can support at least 50kg (110lbs).
•
Ensure that the path to transport the instrument is clear of obstructions.
•
At least two people are needed to lift and carry the instrument.
•
Keep your spine in a good neutral position.
•
Bend at the knees and lift with your legs.
•
Do not lift an object and twist your torso at the same time.
•
Coordinate your intentions with your assistant before lifting and carrying.
Prepare for shipping
1.
Touch .
2.
Touch Service Tools.
3.
Touch Ship prep mode.
Drawer opens.
4.
Remove turntable.
5.
Touch Next.
6.
Power o the instrument.
Chapter5Maintain the instrument
Move the instrument
5
38
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™
Imaging Systems User Guide
Invitrogen
™
iBright
™
SAE Software
Solution for 21 CFR Part 11
Support
Security Audit e-Signature (SAE) for the iBright
™
Imager
IMPORTANT! 21 CFR part 11 is a regulation that describes the criteria for acceptance by the
U.S. Food and Drug Administration (FDA) for electronic records and electronic signatures. Part 11
is composed of procedural and technical requirements. Procedural requirements are the standard
operating procedures instituted by the end user, and technical requirements are the functional
characteristics of the compliance management software used.
This section is intended to provide instructions for using Security, Audit, and E-Signature (SAE)
on board iBright
™
Imaging Systems. Security, Audit, e-Signature (SAE) software provides the tools
necessary for supporting 21 CFR Part 11 technical compliance including:
•
Creating and maintaining user accounts
•
Managing and enforcing password policies of all accounts
•
Assigning, managing and enforcing access rights to all accounts
•
Documenting and maintaining audit and e-Signature histories
•
Permitting e-Signature approval for data verification
To implement the iBright
™
SAE Software Solution for 21 CFR Part 11 support on iBright
™
Imaging
Systems, you need the following components installed, activated, and communicating:
•
SAE Administrator Console — With the iBright
™
Imager Analysis Application Profile, used to
configure the SAE settings for iBright
™
Imaging Systems
•
iBright
™
SAE License — Used to activate the SAE settings for the iBright
™
instrument and desktop
analysis software
•
iBright
™
Instrument – SAE Mode — Firmware connected with the SAE Administrator Console
•
iBright
™
Analysis Software – Secure — Desktop analysis software connected with the SAE
Administrator Console
Note: For details on accessing iBright
™
SAE Software Solution downloads and resources, see the
"Related documentation and references" section.
6
iBright
™
Imaging Systems User Guide
39
Activate your license key
1.
Log in as Local Admin on the instrument.
IMPORTANT! Only the Local Administrator (Local Admin) has the ability to activate the license
key on the instrument. The license key only needs to be activated one time.
Note: Running an instrument qualification using Installation Qualification/Operational
Qualification/Performance Qualification (IQ/OQ/PQ) is recommended before SAE mode is enabled
on the iBright
™
imager for the first time.
2.
Touch Settings on the right of the top toolbar.
3.
Touch SAE.
4.
Touch SAE License.
5.
Enter the SAE License Activation Code and touch Next.
Note: If the license validation is successful, "Registration complete" appears.
Note: The license activation code is case sensitive.
6.
Press Done. The activation code will be saved.
7.
Enter the IP address and port of the SAE console location, then touch Next.
Note: IP address and port location (e.g., 10.X.X.X:8201/admin-console/index.html) are available in
the address bar of the SAE Admin Console.
Enable SAE mode
1.
Log in as Local Admin on the iBright
™
instrument.
IMPORTANT! Only the Local Administrator (Local Admin) has the ability to enable SAE mode on
the iBright
™
imager.
2.
Touch Settings located on the right side of the top tool bar.
3.
Touch SAE.
4.
Touch SAE mode.
5.
Move the slider to Enable, then touch Next.
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Activate your license key
6
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™
Imaging Systems User Guide
6.
If not already done during the license activation, enter the IP address and port of the SAE console
location and then touch Next.
Note: IP address and port location (e.g., 10.X.X.X:8201/admin-console/index.html) are available in
the address bar of the SAE Admin Console.
7.
The system will require the SAE Administrator to enter their credentials to complete the process.
Enter credentials and touch Next to complete the process.
Disable SAE mode
1.
Log in as Local Admin or SAE Console Admin on the iBright
™
instrument.
2.
Touch Settings located on the right side of the top tool bar.
3.
Touch SAE.
4.
Touch SAE mode.
5.
Move the slider to Disable, then touch Next.
6.
At this point the SAE Admin may need to enter their credentials and touch Disable to continue or
Cancel to leave the SAE mode enabled.
7.
If user touches Disable, then the following warning will pop up:
Note: SAE users will not be able to access their current images when SAE is disabled. You
can backup or export those files before disabling SAE. Image files remain on the system and
can be accessed when SAE mode is enabled again.
Note: It is recommended an SAE Admin perform this action. If a Local Admin performs this action
then it will not be recorded in the audit history on the SAE Admin Console.
Sign in to the instrument in SAE mode
1.
Enter your SAE username and password in the SAE login window.
Note: Your username and password must be created by the SAE Admin on the SAE Console prior
to logging in.
2.
Touch Sign In. After signing in, you may be prompted to change your SAE password.
IMPORTANT!
The following symbols cannot be used in your password: + & % \
Note:
The following characters can be used in addition to letters and numbers for passwords: - _
( ) [ ] { } / ~ ! @ # $ * ^ = . , ' " : ; | < > ?
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Disable SAE mode
6
iBright
™
Imaging Systems User Guide
41
Change your password in SAE mode
1.
Touch User Profile on the left side of the top toolbar.
2.
Touch Edit and enter your old password, your new password, and then confirm your new
password.
IMPORTANT! The following symbols cannot be used in your password: + & % \
Note: The following characters can be used in addition to letters and numbers for passwords: - _
( ) [ ] { } / ~ ! @ # $ * ^ = . , ' " : ; | < > ?
Note: Your new password must meet the complexity requirements set by the SAE Console
Admin.
Note: If you exceed the maximum number of sign-in attempts, you will be temporarily locked out
of your account. See the SAE Console Admin.
Note: You may have limited access to iBright
™
instrument functions based on your user role set
by the SAE Console Admin. in the SAE Console.
SAE user roles
Role
Description
SAE Console Administrator (SAE
Console Admin)
A default system role with full access privileges to the SAE Console. The SAE
Console Admin creates new SAE user accounts, defines what privileges are
granted to each SAE user role, and assigns user roles to all other SAE users.
iBright
™
Administrator A default SAE role with privileges to use and manage the iBright
™
instrument
and iBright
™
Analysis Software – Secure.
iBright
™
Scientist A default SAE role with privileges to use the iBright
™
instrument and iBright
™
Analysis Software – Secure.
Chapter6Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Change your password in SAE mode
6
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™
Imaging Systems User Guide
SAE privileges for default user roles
Category
Function
Default Roles
SAE Console
Admin
iBright
™
Admin
iBright
™
Scientist
Image Management
Acquire, Analyze, Adjust, Export, and
Delete
Yes Yes Yes
Security
Configuration
Sign g2i File, Unlock g2i File Yes Yes Yes
Enable SAE on instrument
[1]
Yes No No
Disable SAE on instrument Yes Yes No
Instrument
Configuration
Administer Instrument, Update
Instrument System Configuration
Yes Yes No
Service Tools
Instrument Diagnostics, Pixel
Mapping, and Export Workspace
Yes Yes No
[1]
Enabling SAE on board iBright
™
instruments requires the Local Admin (initiate) and the SAE Console Admin (approve).
Non-SAE user roles
Role
Description
Local Administrator (Admin) Local Admin has full administrator access to the iBright
™
instrument when
SAE mode is disabled. When SAE mode is enabled, this non-SAE role is only
allowed to enable and disable SAE mode and to change their own password.
Field Service Representative (FSE) FSE must log into the iBright
™
instrument when SAE mode is disabled to have
full access to the Service Tools.
Chapter6Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
SAE privileges for default user roles
6
iBright
™
Imaging Systems User Guide
43
Acquire images in SAE mode
Image acquisition in SAE mode is the same as in non-SAE mode.
For iBright
™
CL750 instruments, see the "Choose imaging mode and start image capture" section of the
iBright
™
CL750 Imaging System User Guide (MAN0018652).
For iBright
™
CL1500/FL1500 instruments, see the "Choose imaging mode and start image capture"
section of the iBright
™
CL1500/FL1500 Imaging Systems User Guide (MAN0018592).
Note: In SAE mode, data is committed to the audit log as v1 at image acquisition.
Use the Gallery in SAE mode
File status
File status is depicted on the thumbnails in the Gallery using the following symbols:
•
X – Uncommitted: Image file(s) with uncommitted changes
•
– Committed: Image file(s) with committed changes (saved)
•
– Signed Data (locked): Image file(s) with committed changes and required e-Signatures
Filter Gallery by file status
1.
To filter or sort image files in the iBright
™
Gallery by file status, touch Filter options.
2.
Check the appropriate boxes.
•
X – Uncommitted: Image file(s) with uncommitted changes
•
– Committed: Image file(s) with committed changes (saved)
•
– Signed Data (locked): Image file(s) with committed changes and required e-Signatures
Archive/Backup g2i image files in SAE mode
All SAE users have an individual gallery for viewing and managing their own secured image files. SAE
users with privileges to configure the iBright
™
instrument can manage all user galleries simultaneously
or individually.
1.
Touch Gallery.
Note: You can view the image files in the Gallery as thumbnails or a list. In list view, the user can
sort by file name, imaging mode, file size (kB), or acquisition date.
2.
Touch Filter options.
Note: Galleries can be filtered by acquisition date and imaging mode.
3.
(Optional) Check the box Include guest's images to include the guest gallery.
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Acquire images in SAE mode
6
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™
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4.
Check the Images box for all users to view images from all user galleries.
5.
(Optional) Check the Images for all users box, touch Enter ID, and choose the desired username
of the individual gallery that you want to manage.
6.
Touch Done. In the filtered Gallery, select the desired image file(s) or touch Select All to select all
image files in the Gallery.
7.
Touch
Export to archive/backup the selected g2i file(s) or touch to delete.
IMPORTANT! If an excessive number of files are selected, touching Actions is not
recommended. This may result in long wait times or possibly a system crash. Wait time is directly
proportional to the number of and total size of the selected image files.
Note: Action in the Gallery is intended for viewing image information, image adjustments, image
analysis, file renaming, and file export with no more than 50 image files in the tray. Bulk export and
delete should be done in the main Gallery using Export or Delete, respectively.
Commit changes
In SAE mode, user changes (acquisition, analysis, adjustments, editing, renaming, and export) are
recorded in the audit history for each image file. After image acquisition, the file is automatically
committed, and the audit history is initiated. All additional changes are maintained as uncommitted
changes and ocially become part of the audit history when the user commits the change(s).
Note: The Commit Changes button is only available if the file(s) you are reviewing have uncommitted
changes (X).
1.
To commit changes for an image file(s) in the gallery, select the desired image file(s) and touch
Actions.
2.
Touch Commit Changes.
Note: The Commit Changes button is also available in the More Options menu in the
acquisition, analyze, and adjust workflows.
3.
Touch Reason for Commit and from the dropdown menu choose the appropriate reason.
Note: Reason for Commit will appear based on settings in the SAE Admin Console. If Required
or Optional, users will have the ability to indicate the reason. If set to Silent, changes will be
committed to the audit log, but no reason will be prompted.
4.
Touch Save. If successful, a window will show Changes committed.
Note: Once complete, the file status changes from Uncommitted (X) to Committed ( ) and a
new audit version is added to the audit history. The Commit button is dynamic and once changes
are committed, it changes to Sign Data (see “Sign data” on page46) to allow the user to perform
that action.
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Commit changes
6
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™
Imaging Systems User Guide
45
Sign data
In SAE mode, committed image files can be e-signed by one or more users to verify data integrity.
The SAE Console Admin can dictate what actions require signatures and the number of user roles that
are required to e-sign for each action. Once an image file has been e-signed by all required signees, it
becomes a signed file and is locked from future edits.
1.
To sign a committed file, touch Sign Data.
Note: The Sign Data button is also available under More options in the acquisition, analyze, and
adjust workflows.
2.
Select the Meaning for signing the file from the drop-down menu.
IMPORTANT! If more than one e-Signature is required on the imager, all signatures must be
collected before exiting the e-Signature workflow or the process must be repeated (i.e., all signers
must be present).
3.
Touch Next.
Note: A series of icons will be displayed for all required signatures. Role requirements will be
listed below.
4.
Select any Press to Sign button.
5.
Enter your Username and Password.
6.
Touch Done. If credentials are accepted the user returns to the Sign Data screen.
7.
Repeat steps 4-6 until all required signatures are collected, the file status changes from Committed
( ) to Signed/Locked ( ), and they are recorded in the e-Signature history with an active status.
Unlock files
In SAE mode, signed files are locked and must be unlocked by a user with unlock privileges before any
further changes can be made to the file. When a file is unlocked, the file’s e-Signature status changes to
inactive.
1.
In the Gallery, select the desired image file(s), touch Actions and then touch Unlock.
Note: The user will be warned that they are about to inactivate the signature.
Note: Unlock is also available under More Options in the acquisition, analyze, and adjust
workflows.
2.
The user must comment about why the file is being unlocked, then touch Unlock.
•
A message informs you when the file has been successfully unlocked.
•
e-Signature becomes inactive in the e-Signature history status.
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Sign data
6
46
iBright
™
Imaging Systems User Guide
Generate an audit history
1.
Touch Audit history to review the audit history and the change table for the selected image file.
•
The audit history contains the following information: Version, Date & Time, Username, Role,
Action, Reason and Comment.
•
Audit history is also available in the Adjust and Analyze workflows under More options.
2.
Select one row in the audit history to view the image and change details for the selected and
previous version or select any two rows to view the images and change details for the two selected
versions.
3.
Touch Open to view and compare the images from selected versions.
4.
(Optional) Change the channel from the drop-down menu on top of the image to view a dierent
channel image in a multichannel image.
5.
(Optional) Select/deselect layer options on the top of image to show/hide the layers on image.
6.
Touch Audit Report to generate the Audit History Report as a pdf file. The report contains an audit
history table along with the image comparisons of the selected versions.
7.
Touch
Export to export the Audit History Report to a USB drive, network drive, or network
printer.
View the e-Signature history
Touch e-Signature history to review the e-Signature history.
Note: The e-Signature History contains the following information: Commit version, Signed Date (and
time), Signed By, Signed Role, Meaning, and Status.
Note: e-Signature History is also available in the Adjust and Analyze workflows under More options.
Export image files
Touch Export to export an image as a g2i file type.
Note: Other file extensions are available, but only g2i files can be securely exported from the iBright
™
instrument and opened in the iBright
™
Analysis Software – Secure.
Note: Uncommitted files cannot be exported.
Note: g2i files can be exported as signed or unsigned files based on the file status.
Chapter6
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Generate an audit history
6
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™
Imaging Systems User Guide
47
Generate and export Analysis Report
Touch Generate Report under the More options menu to generate a PDF report with image
information, channel images, and densitometry data.
Note: When generating reports from an unsigned g2i file, you will be prompted to cancel the report
generation and sign the file to generate the signed report; or proceed to generate unsigned report.
Note: Reports generated from signed g2i files can be exported only as signed reports.
Chapter6Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Generate and export Analysis Report
6
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™
Imaging Systems User Guide
Instrument specifications
Instrument dimensions and specifications
Specification
iBright
™
Imager
Dimensions (L × W × H) 68.0 × 38.2 × 59.8 cm
Weight 52 kg (115 lbs)
Instrument clearance (Back) 15.25 cm (6 in.)
Electrical requirements
WARNING! For safety, the power outlet used for powering the instrument must be accessible at all
times. In case of emergency, you must be able to immediately disconnect the main power supply to
the instrument. Allow adequate space between the wall and the equipment so the power cord can be
disconnected in case of emergency.
•
Electric receptacle with grounding capability
•
Maximum power dissipation: ~960 W (not including computer and monitor)
•
Mains AC line voltage tolerances must be up to ±10 percent of nominal voltage
Device
Rated voltage
Circuit
required
Rated
frequency
Rated power
iBright
™
Imager 100–240 ±10% VAC
[1]
10 A 50/60 Hz 410 W
[1]
If the supplied power fluctuates beyond the rated voltage, a power line regulator may be required. High or low voltages can adversely
affect the electronic components of the instrument.
Environmental requirements
Condition
Acceptable range
Installation site Indoor use only
Electromagnetic interference Do not use this device in close proximity to sources of strong
electromagnetic radiation (for example, unshielded intentional RF sources).
Strong electromagnetic radiation may interfere with the proper operation of
the device.
A
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™
Imaging Systems User Guide
49
(continued)
Condition
Acceptable range
Altitude Between sea level and 2000m (6500ft.) above sea level
Operating conditions
•
Humidity: 15–80% relative humidity (noncondensing)
•
Temperature: 15 to 30°C (59 to 86°F)
Note: For optimal performance, avoid rapid or extreme fluctuations in
room temperature.
Storage and transport
conditions
•
Humidity: 20–80% relative humidity (noncondensing)
•
Temperature: –30 to 60°C (–22 to 140°F)
Thermal output During operation, the net thermal output, based on the actual current draw
of the instrument, is expected to be approximately 960 W (3275Btu/h).
Vibration Ensure that the instrument is not adjacent to strong vibration sources,
such as a centrifuge, pump, or compressor. Excessive vibration will aect
instrument performance.
Pollution degree The instrument has a Pollution Degree rating of II. The instrument may only
be installed in an environment that has nonconductive pollutants such as
dust particles or wood chips. Typical environments with a Pollution Degree II
rating are laboratories and sales and commercial areas.
The noise output of the instrument is £ 55 dB(A) when running.
Other conditions Ensure the instrument is located away from any vents that could expel
particulate material onto the instrument components.
Avoid placing the instrument and computer adjacent to heaters, cooling
ducts, or in direct sunlight.
Network requirements
The instrument:
•
Is factory-configured for IPv4 TCP/IP communication and includes an Ethernet adapter
(100/1,000 Mbps) with an RJ45-type connector for integrating the device into a local area network
(LAN).
•
Can alternatively be configured for wireless networking (High Power USB WiFi Module required,
sold separately as an optional accessory).
The instrument can be configured for either wired or wireless networking, not both.
If a Thermo Fisher Scientific service representative is to install the instrument:
•
If the instrument will be connected to a LAN, an active, tested network jack must be in place before
the scheduled installation date.
•
A representative from your information technologies department must be available during the
installation to help connect the instrument to your network.
AppendixA
Instrument specifications
Network requirements
A
50
iBright
™
Imaging Systems User Guide
Required materials to network the instrument:
•
Wired—Ethernet cable of sucient length with RJ45 connectors
–
CAT5 cable for a 100Mbps network connection
–or–
•
Wireless—High Power USB WiFi Module (Cat.No.A26774, sold separately)
Instrument and computer connections
iBright
™
Imager front view
1
2
3
1
Touchscreen
2
USB port
3
Sample stage/turntable
AppendixAInstrument specifications
Instrument and computer connections
A
iBright
™
Imaging Systems User Guide
51
iBright
™
Imager rear view
1
2
4
5
3
1
USB port
2
Ethernet port — RJ45 port for 10/100 Mbps ethernet communication with the instrument
3
Fuse cover
4
Power switch
5
Power port — 100-240 VAC
AppendixAInstrument specifications
Instrument and computer connections
A
52
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Safety
WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user
documentation may result in personal injury or damage to the instrument or device. Ensure that
anyone using this product has received instructions in general safety practices for laboratories and
the safety information provided in this document.
·
Before using an instrument or device, read and understand the safety information provided in the
user documentation provided by the manufacturer of the instrument or device.
·
Before handling chemicals, read and understand all applicable Safety Data Sheets (SDSs) and use
appropriate personal protective equipment (gloves, gowns, eye protection, and so on). To obtain
SDSs, visit thermofisher.com/support.
Symbols on this instrument
Symbols may be found on the instrument to warn against potential hazards or convey important safety
information. In this document, the hazard symbol is used along with one of the following user attention
words:
•
CAUTION! – Indicates a potentially hazardous situation that, if not avoided, may result in minor or
moderate injury. It may also be used to alert against unsafe practices.
•
WARNING! – Indicates a potentially hazardous situation that, if not avoided, could result in death or
serious injury.
•
DANGER! – Indicates an imminently hazardous situation that, if not avoided, will result in death or
serious injury.
Symbol
English Français
Caution, risk of danger
Consult the manual for further safety
information.
Attention, risque de danger
Consulter le manuel pour d’autres
renseignements de sécurité.
Protective conductor terminal (main ground) Borne de conducteur de protection (mise à la
terre principale)
B
iBright
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53
(continued)
Symbol English Français
Do not dispose of this product in unsorted
municipal waste
CAUTION! To minimize negative
environmental impact from disposal
of electronic waste, do not
dispose of electronic waste in
unsorted municipal waste. Follow
local municipal waste ordinances
for proper disposal provision
and contact customer service
for information about responsible
disposal options.
Ne pas éliminer ce produit avec les déchets
usuels non soumis au tri sélectif.
MISE EN GARDE! Pour minimi‐
ser les conséquences négatives sur
l’environnement à la suite de l’éli‐
mination de déchets électroniques,
ne pas éliminer ce déchet électro‐
nique avec les déchets usuels non
soumis au tri sélectif. Se conformer
aux ordonnances locales sur les dé‐
chets municipaux pour les disposi‐
tions d’élimination et communiquer
avec le service à la clientèle pour
des renseignements sur les options
d’élimination responsable.
AppendixBSafety
Symbols on this instrument
B
54
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Location of safety labels on the instrument
Safety information for instruments not manufactured
by Thermo Fisher Scientific
Some of the accessories provided as part of the instrument system are not designed or built by Thermo
Fisher Scientific. Consult the manufacturer's documentation for the information needed for the safe use
of these products.
Instrument safety
General
CAUTION! Do not remove instrument protective covers. If you remove the protective instrument
panels or disable interlock devices, you may be exposed to serious hazards including, but not limited
to, severe electrical shock, laser exposure, crushing, or chemical exposure.
AppendixBSafety
Safety information for instruments not manufactured by Thermo Fisher Scientific
B
iBright
™
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55
Physical injury
CAUTION! Moving Parts. Moving parts can crush, pinch and cut. Keep hands clear of moving
parts while operating the instrument. Disconnect power before servicing.
LED (Light-Emitting Diode)
CAUTION! LED (light-emitting diode) HAZARD. Removing the protective covers and (when
applicable) defeating the interlock(s) may result in exposure to the internal LED. LEDs can burn the
retina, causing permanent blind spots. To ensure safe LED operation:
·
Never look directly into the light beam.
·
Wear proper eye protection and post a warning sign at the entrance to the laboratory if the LED
protection is defeated for servicing
·
Remove jewelry and other items that can reflect a light beam into your eyes or those of others
·
Do not remove safety labels, instrument protective panels, or defeat safety interlocks.
·
The system must be installed and maintained by a Thermo Fisher Scientific Technical
Representative.
AppendixBSafety
Instrument safety
B
56
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Electrical safety
WARNING! Ensure appropriate electrical supply. For safe operation of the instrument:
·
Plug the system into a properly grounded receptacle with adequate current capacity.
·
Ensure the electrical supply is of suitable voltage.
·
Never operate the instrument with the ground disconnected. Grounding continuity is required for
safe operation of the instrument.
AVERTISSEMENT! Veiller à utiliser une alimentation électrique appropriée. Pour garantir le
fonctionnement de l’instrument en toute sécurité :
·
Brancher le système sur une prise électrique correctement mise à la terre et de puissance adéqua‐
te.
·
S’assurer que la tension électrique est convenable.
·
Ne jamais utiliser l’instrument alors que le dispositif de mise à la terre est déconnecté. La continui‐
té de la mise à la terre est impérative pour le fonctionnement de l’instrument en toute sécurité.
WARNING! Power Supply Line Cords. Use properly configured and approved line cords for the
power supply in your facility.
AVERTISSEMENT! Cordons d’alimentation électrique. Utiliser des cordons d’alimentation
adaptés et approuvés pour raccorder l’instrument au circuit électrique du site.
WARNING! Disconnecting Power. To fully disconnect power either detach or unplug the power
cord, positioning the instrument such that the power cord is accessible.
AVERTISSEMENT! Déconnecter l’alimentation. Pour déconnecter entièrement l’alimentation,
détacher ou débrancher le cordon d’alimentation. Placer l’instrument de manière à ce que le cordon
d’alimentation soit accessible.
AppendixBSafety
Instrument safety
B
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Cleaning and decontamination
CAUTION! Cleaning and Decontamination. Use only the cleaning and decontamination methods
specified in the manufacturer's user documentation. It is the responsibility of the operator (or other
responsible person) to ensure the following requirements are met:
·
No decontamination or cleaning agents are used that could cause a HAZARD as a result of a
reaction with parts of the equipment or with material contained in the equipment.
·
The instrument is properly decontaminated a) if hazardous material is spilled onto or into the
equipment, and/or b) prior to having the instrument serviced at your facility or sending the
instrument for repair, maintenance, trade-in, disposal, or termination of a loan (decontamination
forms may be requested from customer service).
·
Before using any cleaning or decontamination methods (except those recommended by the
manufacturer), users should confirm with the manufacturer that the proposed method will not
damage the equipment.
MISE EN GARDE! Nettoyage et décontamination. Utiliser uniquement les méthodes de nettoya‐
ge et de décontamination indiquées dans la documentation du fabricant destinée aux utilisateurs.
L’opérateur (ou toute autre personne responsable) est tenu d’assurer le respect des exigences sui‐
vantes:
·
Ne pas utiliser d’agents de nettoyage ou de décontamination susceptibles de réagir avec certaines
parties de l’appareil ou avec les matières qu’il contient et de constituer, de ce fait, un DANGER.
·
L’instrument doit être correctement décontaminé a) si des substances dangereuses sont renver‐
sées sur ou à l’intérieur de l’équipement, et/ou b) avant de le faire réviser sur site ou de l’envoyer
à des fins de réparation, de maintenance, de revente, d’élimination ou à l’expiration d’une période
de prêt (des informations sur les formes de décontamination peuvent être demandées auprès du
Service clientèle).
·
Avant d’utiliser une méthode de nettoyage ou de décontamination (autre que celles recomman‐
dées par le fabricant), les utilisateurs doivent vérifier auprès de celui-ci qu’elle ne risque pas
d’endommager l’appareil.
Instrument component and accessory disposal
To minimize negative environmental impact from disposal of electronic waste, do not dispose of
electronic waste in unsorted municipal waste. Follow local municipal waste ordinances for proper
disposal provision and contact customer service for information about responsible disposal options.
AppendixBSafety
Instrument safety
B
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Safety and electromagnetic compatibility (EMC)
standards
The instrument design and manufacture complies with the following standards and requirements for
safety and electromagnetic compatibility.
Safety compliance
Reference
Description
EU Directive 2014/35/EU European Union “Low Voltage Directive”
IEC 61010-1
EN 61010-1
UL 61010-1
CAN/CSA C22.2 No.
61010-1
Safety requirements for electrical equipment for measurement, control, and
laboratory use – Part 1: General requirements
IEC 61010-2-081
EN 61010-2-081
Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 2-081: Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other purposes
IEC 62471-1:2007 Photobiological safety of lamps and lamp systems
EN 62471-1:2007
EMC
Reference
Description
Directive 2014/30/EU European Union “EMC Directive”
IEC 61326-1 Electrical Equipment for Measurement, Control and
Laboratory Use – EMC Requirements – Part 1:
General Requirements
EN 61326-1
AS/NZS 2064 Limits and Methods of Measurement of
Electromagnetic Disturbance Characteristics of
Industrial, Scientific, and Medical (ISM)
Radiofrequency Equipment
AppendixBSafety
Safety and electromagnetic compatibility (EMC) standards
B
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(continued)
Reference
Description
ICES-001, Issue 4 Industrial, Scientific and Medical (ISM) Radio
Frequency Generators
FCC Part 15 Subpart B (47 CFR) U.S. Standard Radio Frequency Devices
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
Environmental design
Reference
Description
EU Directive 2012/19/EU European Union “WEEE Directive”—Waste electrical and electronic equipment
EU Directive 2011/65/EU European Union “RoHS Directive”—Restriction of hazardous substances in
electrical and electronic equipment
EU Directive 2006/66/EC European Union “Battery Directive”
GB/T 26572-2011 Requirements of concentration limits for certain restricted substances in
electrical and electronic products
SJ/T 11364-2014 Marking for the restricted use of hazardous substances in electronic and
electrical products
产品中有害物质的名称及含量
China EEP Hazardous Substances Information
部件名称
Component
Name
iBright
™
CL1000 Instrument
iBright
™
FL1000 Instrument
有害物质
Hazardous Substances
铅
(Pb)
汞
(Hg)
镉
(Cd)
六价铬
(Cr(VI))
多溴联苯
(PBB)
多溴二苯醚
(PBDE)
电路板
PCBA's
X O O O O O
电源供应器
Power Supply
X O O O O O
AppendixBSafety
Safety and electromagnetic compatibility (EMC) standards
B
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(continued)
产品中有害物质的名称及含量
China EEP Hazardous Substances Information
电机组件
Electromechani
cal Assemblies
X O O O O O
本表格依据 SJ/T11364 的规定编制 This table is compiled according to SJ/T 11364 standard.
O: 表示该有害物质在该部件所有均质材料中的含量均在 GB/T26572 规定的限量要求以下.
Indicates that the concentration of the hazardous substance in all homogeneous materials for the part is
below the relevant threshold of the GB/T 26572 standard.
X: 表示该有害物质至少在该部件的某一均质材料中的含量超出 GB/T26572 规定的限量要.
Indicates that the concentration of the hazardous substance in at least one homogenous material of the
part is above the relevant threshold of the GB/T 26572 standard.
AppendixBSafety
Safety and electromagnetic compatibility (EMC) standards
B
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Chemical safety
WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel
read and practice the general safety guidelines for chemical usage, storage, and waste provided
below. Consult the relevant SDS for specific precautions and instructions:
·
Read and understand the Safety Data Sheets (SDSs) provided by the chemical manufacturer
before you store, handle, or work with any chemicals or hazardous materials. To obtain SDSs, see
the “Documentation and Support” section in this document.
·
Minimize contact with chemicals. Wear appropriate personal protective equipment when handling
chemicals (for example, safety glasses, gloves, or protective clothing).
·
Minimize the inhalation of chemicals. Do not leave chemical containers open. Use only with
adequate ventilation (for example, fume hood).
·
Check regularly for chemical leaks or spills. If a leak or spill occurs, follow the manufacturer's
cleanup procedures as recommended in the SDS.
·
Handle chemical wastes in a fume hood.
·
Ensure use of primary and secondary waste containers. (A primary waste container holds the
immediate waste. A secondary container contains spills or leaks from the primary container.
Both containers must be compatible with the waste material and meet federal, state, and local
requirements for container storage.)
·
After emptying a waste container, seal it with the cap provided.
·
Characterize (by analysis if necessary) the waste generated by the particular applications, reagents,
and substrates used in your laboratory.
·
Ensure that the waste is stored, transferred, transported, and disposed of according to all local,
state/provincial, and/or national regulations.
·
IMPORTANT! Radioactive or biohazardous materials may require special handling, and disposal
limitations may apply.
AVERTISSEMENT! PRÉCAUTIONS GÉNÉRALES EN CAS DE MANIPULATION DE PRODUITS
CHIMIQUES. Pour minimiser les risques, veiller à ce que le personnel du laboratoire lise attentive‐
ment et mette en œuvre les consignes de sécurité générales relatives à l’utilisation et au stockage
des produits chimiques et à la gestion des déchets qui en découlent, décrites ci-dessous. Consulter
également la FDS appropriée pour connaître les précautions et instructions particulières à respecter :
·
Lire et comprendre les fiches de données de sécurité (FDS) fournies par le fabricant avant de
stocker, de manipuler ou d’utiliser les matériaux dangereux ou les produits chimiques. Pour obtenir
les FDS, se reporter à la section « Documentation et support » du présent document.
·
Limiter les contacts avec les produits chimiques. Porter des équipements de protection appropriés
lors de la manipulation des produits chimiques (par exemple : lunettes de sûreté, gants ou vête‐
ments de protection).
·
Limiter l’inhalation des produits chimiques. Ne pas laisser les récipients de produits chimiques
ouverts. Ils ne doivent être utilisés qu’avec une ventilation adéquate (par exemple, sorbonne).
·
Vérifier régulièrement l’absence de fuite ou d’écoulement des produits chimiques. En cas de fuite
ou d’écoulement d’un produit, respecter les directives de nettoyage du fabricant recommandées
dans la FDS.
·
Manipuler les déchets chimiques dans une sorbonne.
AppendixBSafety
Chemical safety
B
62
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·
Veiller à utiliser des récipients à déchets primaire et secondaire. (Le récipient primaire contient les
déchets immédiats, le récipient secondaire contient les fuites et les écoulements du récipient pri‐
maire. Les deux récipients doivent être compatibles avec les matériaux mis au rebut et conformes
aux exigences locales, nationales et communautaires en matière de confinement des récipients.)
·
Une fois le récipient à déchets vidé, il doit être refermé hermétiquement avec le couvercle fourni.
·
Caractériser (par une analyse si nécessaire) les déchets générés par les applications, les réactifs et
les substrats particuliers utilisés dans le laboratoire.
·
Vérifier que les déchets sont convenablement stockés, transférés, transportés et éliminés en res‐
pectant toutes les réglementations locales, nationales et/ou communautaires en vigueur.
·
IMPORTANT ! Les matériaux représentant un danger biologique ou radioactif exigent parfois une
manipulation spéciale, et des limitations peuvent s’appliquer à leur élimination.
Biological hazard safety
WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents,
and blood of humans and other animals have the potential to transmit infectious diseases.
Conduct all work in properly equipped facilities with the appropriate safety equipment (for example,
physical containment devices). Safety equipment can also include items for personal protection,
such as gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses, or
goggles. Individuals should be trained according to applicable regulatory and company/ institution
requirements before working with potentially biohazardous materials. Follow all applicable local,
state/provincial, and/or national regulations. The following references provide general guidelines when
handling biological samples in laboratory environment.
·
U.S. Department of Health and Human Services, Biosafety in Microbiological and Biomedical
Laboratories (BMBL), 5th Edition, HHS Publication No. (CDC) 21-1112, Revised December 2009;
found at:
https://www.cdc.gov/labs/pdf/CDC-BiosafetymicrobiologicalBiomedicalLaboratories-2020-
P.pdf
·
World Health Organization, Laboratory Biosafety Manual, 3rd Edition,
WHO/CDS/CSR/LYO/2004.11; found at:
www.who.int/publications/i/item/9789240011311
AppendixBSafety
Biological hazard safety
B
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Documentation and support
Related documentation and references
Product Details
Product Description Webpage URL
iBright
™
Analysis Software
Connect
Cloud-based iBright
™
Analysis Software
Connect is supplied with one free terabyte of
digital data storage.
http://thermofisher.com/
Connect
iBright
™
Imager Firmware Firmware updates and patches for all iBright
™
Instruments are available for download on the
Thermo Fisher website.
http://thermofisher.com/
iBrightAnalysis
iBright
™
Analysis Software iBright
™
Analysis Software (desktop version)
is for managing, adjusting, analyzing, and
annotating G2i digital image files that were
captured on an iBright
™
Imager.
iBright
™
Analysis Software –
Secure
iBright
™
Analysis Software - Secure (desktop
version) supports 21 CFR Part 11 compliance.
SAE Administrator Console
Software
SAE Administrator Console Software supports
21 CFR Part 11 compliance by providing
security, audit, and e-Signature (SAE) for
iBright
™
Instruments and iBright
™
Analysis
Software – Secure.
SAE License for iBright
™
License for Security, Audit, and e-Signature
(SAE) on iBright
™
Instruments and iBright
™
Analysis Software – Secure.
Document Publication number Description
iBright
™
Imaging Systems
Documentation
100085109 Provides instructions for obtaining
service and technical support for the
iBright
™
Imaging Systems.
iBright
™
Imaging Systems Quick
Reference
100085108 Provides basic instructions for
performing imaging with the iBright
™
Imaging Systems.
C
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Imaging Systems User Guide
Customer and technical support
Visit thermofisher.com/support for the latest service and support information.
•
Worldwide contact telephone numbers
•
Product support information
–
Product FAQs
–
Software, patches, and updates
–
Training for many applications and instruments
•
Order and web support
•
Product documentation
–
User guides, manuals, and protocols
–
Certificates of Analysis
–
Safety Data Sheets (SDSs; also known as MSDSs)
Note: For SDSs for reagents and chemicals from other manufacturers, contact the
manufacturer.
Limited product warranty
Life Technologies Corporation and/or its aliate(s) warrant their products as set forth in the
Life Technologies' General Terms and Conditions of Sale at www.thermofisher.com/us/en/home/
global/terms-and-conditions.html. If you have any questions, please contact Life Technologies at
www.thermofisher.com/support.
AppendixCDocumentation and support
Customer and technical support
C
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™
Imaging Systems User Guide
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iBright CL1500_FL1500 Instruments User Guide_UG_MAN0018592-v6-
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18:00:57.116Z
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