Hach LightDeck MINI User manual

L-80-00043-SCCC Rev 01
User Guide
LightDeck MINI System
Please see the test cartridge package insert for test-specific information.
Software version 1.0 or greater

Contents
Symbols........................................................................................................................................ iii
Introduction................................................................................................................................... 1
Description.........................................................................................................................................................................1
Principle of Operation...................................................................................................................................................1
Safe Usage and Handling Precautions....................................................................................... 2
Precautions.......................................................................................................................................................................2
Biohazards and Waste.................................................................................................................................................2
Electrical Hazards...........................................................................................................................................................2
Laser Warnings...............................................................................................................................................................3
Other Safety Warnings.................................................................................................................................................3
LightDeck MINI Overview............................................................................................................. 4
Installation..........................................................................................................................................................................4
LightDeck MINI Front, Back, and Bottom Views................................................................................................4
Instrument Label..............................................................................................................................................................5
LightDeck MINI Specifications...................................................................................................................................5
Calibration..........................................................................................................................................................................5
Navigation..........................................................................................................................................................................5
Import Lot-Specific Calibration Data with New Cartridge Lots............................................... 6
RUN TEST...................................................................................................................................... 7
Start instruments and software.................................................................................................................................7
Test Procedure................................................................................................................................................................7
Read cartridge.................................................................................................................................................................8
VIEW DATA.................................................................................................................................. 10
Maintenance and Cleaning ........................................................................................................ 12
How to Clean Outside Surfaces............................................................................................................................. 12
Troubleshooting.......................................................................................................................... 12

Symbols
Consult instructions for use
Serial number
Batch code/lot number
Catalog number
Use by YYYY-MM-DD
Temperature limit
Caution, consult accompanying documents
Biological risk/Biohazard
Electrical hazard
Manufacturer
Date of manufacture
Do NOT recycle. In compliance with European Directive 2002/96/EC on waste
electrical and electronic equipment (WEEE), this equipment must not be disposed
of as unsorted municipal waste. Instead, it must be collected separately in
accordance with local recycling regulations. Presence of the symbol indicates
that compliance must be adhered to for this device on waste electrical and
electronic equipment (WEEE).
DC electrical power rating

Introduction
1
Introduction
The LightDeck MINI System (hereafter referred to as LightDeck MINI) is used in conjunction
with LightDeck test cartridges. Please refer to the test cartridge package insert for test-specific
information.
The LightDeck MINI and test cartridges are manufactured by MBio Diagnostics, Inc. (dba
LightDeck Diagnostics), based in Boulder, CO, USA.
Disclaimers
1. LightDeck Diagnostics shall not be liable for malfunctions and damage resulting from
installation, relocation, remodeling, or LightDeck MINI repair done by vendors other than
those specified by LightDeck Diagnostics.
2. LightDeck Diagnostics shall not be liable for malfunctions and damage of LightDeck
Diagnostics products due to the use of products of other manufacturers not supplied by
LightDeck Diagnostics.
3. LightDeck Diagnostics shall not be liable for malfunctions and damage resulting from
negligence of precautions and operating methods contained in this manual.
4. LightDeck Diagnostics shall not be liable for malfunctions and damage resulting from use
under environmental conditions outside the range of conditions required for proper use of
this product (e.g., power supply, installation environment) described in this manual.
5. LightDeck Diagnostics shall not be liable for malfunctions and damage resulting from natural
disasters such as fires, earthquakes, and floods.
The LightDeck MINI is used with LightDeck test cartridges to perform immunoassays.
Description
The LightDeck MINI is an automated fluorescence analyzer. The LightDeck MINI is run by
software on a computer that is connected to the LightDeck MINI. The user interface on the
computer guides you through the test procedure. Results are displayed at the end of the test and
may be viewed, exported, or printed.
Principle of Operation
Planar waveguides with a printed microarray are assembled into disposable plastic cartridges.
Each spot in the microarray measures a biomarker or built-in control. Light is focused through
an integrated lens to create an evanescent field just above the surface of the waveguide. This
evanescent field excites only the fluorescent dye that is bound by the capture antibody on the
waveguide. At the end of the test, a laser turns on to excite bound dye. A camera reads
fluorescence signal and software converts signal to quantitative concentrations of biomarkers. The
result is displayed on the screen in µg/L.

Safety Information
2
Safe Usage and Handling Precautions
This section contains safety precautions which must be followed for safe operation of the
LightDeck MINI .
Precautions
Before using the LightDeck MINI, read this User Guide to ensure correct operation.
Observe the precautions. Failure to do so may result in injuries, cause property
damage, or produce incorrect results.
The LightDeck MINI is to be operated by personnel trained for its intended use and
correct operation.
Biohazards and Waste
Wear appropriate Personal Protective Equipment (e.g., wear gloves, lab coat, and
eye protection). Follow biohazard procedures when handling samples and cleaning
the LightDeck MINI.
Used test cartridges, pipette tips, and contaminated swabs or cloths used for cleaning
equipment are potentially infectious waste and disposal must follow applicable local,
state, or federal regulations.
When discarding the LightDeck MINI that may be contaminated with sample, disposal
must follow applicable local, state, or federal regulations.
Electrical Hazards
Use only the power supply included with the LightDeck MINI. The power supply
voltage applied to the equipment is AC90-264V –2.5A, 50-60 Hz.
To avoid electrical shock, observe the following precautions:
•Avoid installation location where water may splash on the equipment.
•Plug the power cable into an outlet with a grounding receptacle.
•Make sure that all cables/cords have been properly connected.
When plugging the power supply in or removing it from an outlet, grasp the plug (not
the cord) to prevent damage to the cord.
There are no user serviceable parts. Do not remove covers or other parts to avoid
electrical shock or injury from moving parts.

Safety Information
3
Laser Warnings
The LightDeck MINI includes an embedded laser. The equipment complies with FDA
performance standards for laser products except for deviations pursuant to Laser Notice No. 50,
dated June 24, 2007.
The LightDeck MINI is considered a Class 1 laser product per IEC 60825-1: 2007.
Do not open the LightDeck MINI. The LightDeck MINI has no user serviceable parts.
Any unauthorized opening of the instrument can cause potential hazards, can expose
hazardous laser radiation, and will invalidate warranty claims.
The LightDeck MINI is a Class 1 laser device. A light-tight enclosure and a safety
interlock prevents the internal laser source from emitting laser light, should the test
cartridge door be opened when a cartridge is not present.
If the enclosure is damaged, immediately stop using the LightDeck-MINI to prevent
possible exposure to hazardous laser radiation.
Caution –Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Other Safety Warnings
EXPLOSIVE HAZARD: Do not use flammable and explosive gas around the
equipment.
Do not place fingers into the LightDeck MINI test cartridge door.
Test cartridges are single use only. Do not reuse test cartridges.
Only insert test cartridges manufactured by LightDeck Diagnostics. Do not insert
damaged or used test cartridges into the LightDeck MINI.
Wear appropriate Personal Protective Equipment for the sample type being tested
when using the LightDeck MINI.
Only connect the LightDeck MINI to a USB 2.0 or USB 3.0 port of a host computer.
Use only the USB cable provided with the LightDeck MINI.

Overview
4
LightDeck MINI Overview
The LightDeck MINI ships in a custom-designed protective box. Use only these protective boxes
if you must transport the components.
The following items are supplied with your LightDeck MINI:
1. LightDeck MINI
2. Power supply and cord
3. USB cable
4. 100 µL fixed volume pipette
5. 30 disposable pipette tips
6. USB flash drive containing LightDeck-T software
7. User Manual
Installation
1. Unpack the LightDeck MINI and place it on a level, stable surface. Inspect for any
obvious signs of damage. Report any damage immediately.
2. Install the software from the USB flash drive supplied with the LightDeck MINI.
1. Insert the USB flash drive in the computer.
2. Double click on the installation file.
3. Follow the installation procedure as directed by the software.
4. Plug in the power sources for the computer and LightDeck MINI.
5. Attach USB cable from the LightDeck MINI to the computer.
3. Before using, allow the LightDeck MINI to equilibrate to the surrounding temperature for
at least 30 minutes. Operating temperatures depend on the test cartridges, but are
typically 50–104 °F, 10 –40 °C.
LightDeck MINI Front and Back Views
USB Port
Front View
Test Cartridge Door
Power Supply Input
Back View

Overview
5
Instrument Label
LightDeck MINI Specifications
Detection system
Fluorescence immunoassay instrument
Cartridge
Compatible with test cartridges manufactured by
LightDeck Diagnostics
Electrical power rating
+12DC / 2.5A max
Wall Power
AC90-264V –2.5A, 50-60 Hz.
Laser classification
Laser Class 1 (per IEC 60825-1)
Operating temperature
Specific to test cartridges, typically 50–104°F, 10 –
40°C
Operating relative humidity
25 –65%, non-condensing
Storage temperature
0 –45°C
Storage humidity
5 –95%, non-condensing
Altitude
0-2000 m
Weight
3.5 pounds, 1.5 kg
Physical dimensions
4.4 (W) x 5.9 (H) x 6.1 (L) inches
112 (W) x 150 (H) x 155 (L) millimeters
Calibration
The LightDeck MINI is factory calibrated. No user calibration or verification required.
Software Interface
The Home Screen lets you navigate to modules to run sample or quality control tests, to view
stored sample results or QC data, or import cartridge definition files.
RUN TEST: Test samples
VIEW DATA: Review stored data
IMPORT: A lot-specific cartridge definition file must be uploaded for
each new lot of reagent. It contains calibration information.
INFORMATION: Application information and legal

Overview
6
Import Lot-Specific Calibration Data with New Cartridge Lots
Each test cartridge lot is factory calibrated. Lot-specific calibration data must be loaded from the
USB flash drive that is included with each box of test cartridges. If the file is missing, you will get
a message to load the calibration data from the USB flash drive. Alternatively, calibration data
can be downloaded from the internet by following the prompts in the LightDeck-T software.
1. Turn on the computer
2. Start LightDeck-T software by double clicking the LightDeck-T icon on the desktop to
launch the software.
3. Import the calibration file
4. Select IMPORT.
5. Navigate to the USB drive. Double click the xxx.cdf.xml file. Alternatively, select
INTERNET to download the file.
6. Select “Update Now” to import the calibration information.
The LightDeck-T software will import the cartridge definition file and calibration information. Do
not remove the USB drive until the screen shows “Completed successfully.”

Run Test
7
RUN TEST
This section tells you how to run a test or QC test. The examples show screen shots for a
LightDeck MC + CYN Test Cartridge.
If cartridges were refrigerated, allow to warm to room temperature for at least 15 minutes.
Start instruments and software
1. Turn on the computer
2. Start LightDeck-T software
3. Double click the LightDeck-T icon on the desktop to launch the software.
Test Procedure
Click the RUN TEST button.
Enter sample information.
•Choose a test from the drop-down
menu.
•Enter Sample Information
•Click ACCEPT to load your inputs.
Open the pouch. Remove the test
cartridge.
•Avoid touching the clear plastic on the
bottom of the test cartridge.
•Label the test cartridge with a sample
ID.
Caution: A desiccant sachet should also
be in the pouch. Discard the cartridge if
the desiccant sachet is not present.

Run Test
8
Add sample to reagents.
•Add 100 Lsample to the microtube
containing dried reagents.
•Mix by aspirating and dispensing 10
times until the reagents are fully
rehydrated and well mixed with the
sample.
•When using the pipette depress the
plunger fully before aspirating.
Add sample to cartridge
•Dispense 100 Lcombined sample
and reagents into the sample port of
the test cartridge.
Read cartridge
Open cartridge door.
•Click READY to open the test cartridge
door.
Tip: The door will automatically close after
30 seconds, so click Ready when you are
ready to insert the test cartridge. If the door
closes, just click Ready again.

Run Test
9
Insert the cartridge.
•Insert the test cartridge.
The LightDeck MINI reads the test cartridge
bar code and populates the rest of the
Sample Information.
Test Processing
The rest of the test is automatic. For most
test cartridge types, the processing time is
10 minutes.
Test Complete
Results are displayed.
Click DONE to release the cartridge and
remove it from the LightDeck MINI.
Export Test Results
If a PDF report for the sample is desired,
click VIEW DATA, select samples to export,
and click EXPORT.

Review Results
10
Review Results
This section tells you how to view results, create reports, and archive samples.
Click VIEW DATA
❶
❷
❸
Select PDF Summary to export data as .pdf files. Select Excel Spreadsheet to export data in a
spreadsheet format.
You may configure the table to show multiple columns. Click on Select Columns, then click on
the field, and then click on the arrow to move it.

Review Results
11
Select Raw Files to export the six .png files and one .res file that is associated with the sample
measurement.
Overview
The table gives a summary of samples that have not been archived.
Click on the Box and Arrow icon to show the details associated with the sample.
The default order in the table is the most recent test first. Click on the column header to sort in
ascending or descending order. For example, if you use “QC” as part of your naming
convention, you can sort by Sample ID to group QC samples together.
Click Show Archived at the top of the table to show archived samples in the summary table.
EXPORT
❶Click on the format for the export operation.
•You can choose the fields to include in your spreadsheet.
•Click PDF Summary for a summary table of the selected samples, similar to the table
shown on the screen,
•Click PDF Summary and Individual Files for a multi-page PDF with a report for each
sample selected.
•Click Excel Spreadsheet for an Excel file. Each row in the spreadsheet contains data
associated with each sample.
•Individual Files gives you a report for each sample.
❷Click on the Select All box at the top of the table or on individual samples. Click EXPORT to
create the reports or a spreadsheet.
❸Click on the ARCHIVE to hide them from the table. Files are always saved to a default
location on the computer.

Appendix
12
Maintenance and Cleaning
The LightDeck MINI is a maintenance-free instrument and has no user-serviceable parts. When
encountering failures or damage, please contact Technical Support.
Do not open the LightDeck MINI for cleaning or servicing.
How to Clean Outside Surfaces
Use a soft cloth to clean the LightDeck MINI with a mild detergent, 70% solution of ethanol or
isopropyl alcohol in water, or 10% bleach solution.
Do not directly spray the LightDeck MINI with cleaner.
Apply cleaning solutions to a cloth and then wipe the instrument.
Troubleshooting
When an error occurs, a dialog box appears displaying the error message, possible cause and
solution. If you are unable to resolve the problem, please contact Technical Support.
Error Message
Reason Type
Action
The cartridge has expired
Cartridge shelf life
exceeded
Discard expired cartridge. Run
within expiration.
The cartridge contains an
invalid barcode
Did not recognize the
barcode
Re-run the sample using a
new cartridge.
Unable to read the cartridge
barcode
Barcode not read
Verify that barcode is not
damaged and retry. If error
persists, select a new
cartridge.
The inserted cartridge is of
an unknown test type
Cartridge Definition File not
loaded
Load the Calibration Info for
the cartridge lot using the USB
drive provided in the test
cartridge box.
Wrong Cartridge Inserted –
Do you wish to proceed?
Cartridge inserted does not
match requested test
Update sample information to
indicate test type matching the
cartridge type.
Calibration information
needed
Instrument has no record of
cartridge lot information
Load Calibration Info for that
specific cartridge lot using the
USB drive provided in the test
cartridge box.
Unknown error processing
the cartridge
General error
Must run a new cartridge. If
the problem repeats, re-start
the instrument.
Error connecting to hardware
Internal instrument
communication
Restart the instrument. If
problem persists, contact
Customer Support.
Cartridge error
Internal control out of range
Re-run the sample using a
new cartridge
Reference Spots Not Found
Reference internal control
out of range
Re-run the sample using a
new cartridge

Appendix
13
High background detected
Excessive background
Re-run the sample using a
new cartridge if error repeats
dilute sample prior to
measurement with a new
cartridge
Low Internal Positive Control
Flow control reading low
Re-run the sample using a
new cartridge
High Internal Positive Control
Flow control reading high
Re-run the sample using a
new cartridge
Reference Spot Not Found
Reagent pellet error
Re-run the sample using a
new cartridge
Dried Reagents Not Added or
Cartridge Not Punctured
Reagent pellet error or
cartridge error
Re-run the sample using a
new cartridge
Cartridge Hold Failure
Cartridge error
Re-run the sample using a
new cartridge

Appendix
14