Alere Cholestech LDX Manual de usuario
Cholestech LDX®
System User Manual
Read Me First
Congratulations on the purchase of your Alere Cholestech LDX®
System. Please take a few minutes to examine the contents
of your package to be sure that nothing has been damaged in
shipment.
Be sure to read the instructions in this user manual before
operating the Alere Cholestech LDX®Analyzer. If you have any
questions now or in the future, please contact Alere.
Cholestech LDX®
System User Manual
2 Alere Cholestech LDX®System User Manual
Table of Contents
Introduction .....................................................................4
Examining Your Package Contents............................................. 5
How the Alere Cholestech LDX®Analyzer Works........................ 6
Getting Started ..............................................................10
Setting the Conguration Menu ................................................ 12
Conguration Menu Flowchart.................................................. 14
Alere Cholestech LDX®Optics Check....................................... 16
Optics Check Cassette Test Procedure .................................... 17
Testing Procedure..........................................................18
Running a Test........................................................................... 18
Performing a Fingerstick ........................................................... 22
Using Your MiniPet®Pipettes .................................................... 25
Quality Control...............................................................26
Results Outside the Control Range........................................... 28
Risk Assessment ...........................................................30
Coronary Heart Disease (CHD) Risk Assessment Program ...... 30
Performing a CHD Risk Assessment......................................... 31
Risk Assessment Flowchart ...................................................... 33
Risk Assessment Modeling ....................................................... 34
3Alere Cholestech LDX®System User Manual
Troubleshooting & Maintenance ....................................35
Cleaning .................................................................................... 35
Precautions and Warnings ........................................................ 36
Corrective Action....................................................................... 37
Limited Warranty ...........................................................41
General Specications...................................................42
Glossary of Terms ..........................................................43
Contact Alere.................................................................44
Symbols .........................................................................45
4 Alere Cholestech LDX®System User Manual
Introduction
The Alere Cholestech LDX®System is a small, portable analyzer
and test cassette system. It is easy to use and gives fast and
reliable results. To run a test, just add a sample to the cassette
and place it into the analyzer. In a few minutes the results will
appear on the screen.
The Alere Cholestech LDX®System is for in vitro diagnostic use
only. This manual contains all the information you need to operate
and care for the Alere Cholestech LDX®Analyzer. Please read this
entire manual before you use the analyzer.
Alere™ Product Support and Customer Service
Alere will provide every customer with the product support
and training needed to properly use the Alere Cholestech
LDX®System. We maintain a staff of qualied Product Support
Specialists available 24 hours a day, seven days a week.
5Alere Cholestech LDX®System User Manual
Examining Your Package Contents
When you receive your Alere Cholestech LDX® Analyzer, open the
shipping box and check the contents against the packing list.
Please save the shipping box for reuse if you plan to send the
Alere Cholestech LDX®Analyzer and supplies to other sites. The
Alere Cholestech LDX®System Includes:
• Alere Cholestech LDX®Analyzer
• Power Supply
• Optics Check Cassette
• User Manual
• Accessory Tray
• Capillary Tubes
• Capillary Plungers
• Single-use Lancets
• MiniPet®Pipette
• Pipette Tips
• Alere™ Thermal Printer and Cable Assembly
A carrying case is available as an optional accessory.
(The carrying case is not intended for shipping the Alere
Cholestech LDX®Analyzer.)
In addition to these supplies, you may need the following
materials that are not provided with your Alere Cholestech LDX®
System:
• Alere Cholestech LDX®Test Cassettes
• Alere™ Level 1 and 2 Controls
• Biohazardous waste containers
• Alcohol swabs
• Gloves
• Gauze sponges
• Vacuum collection tubes, needles and tube holders
if the sample is to be collected by venipuncture.
6 Alere Cholestech LDX®System User Manual
The Analyzer
The Alere Cholestech LDX®Analyzer has a 32-character display
screen and three buttons that control all the steps needed for
operation. The three buttons are labeled RUN, DATA and STOP.
Liquid Crystal
Display
Data Button
Stop Button
Run Button
How the Alere Cholestech LDX®
Analyzer Works
The Alere Cholestech LDX®Analyzer uses reectance photometry
(the amount of light reected from a solid surface) to measure
the amount of substances in blood. The analyzer measures color
changes of the four reagent pads. The amount of color formed is
converted by the analyzer to a concentration and the results are
shown on the liquid crystal display (LCD) screen.
7Alere Cholestech LDX®System User Manual
RUN:
1. Opens the cassette drawer and activates the analyzer
when the analyzer is hibernating.
2. Starts a test. Press the RUN button after a cassette is
placed in the drawer to start a test.
3. Allows you to enter information into the CHD Risk
Assessment Program and change settings in the
Conguration Menu when used with the DATA button.
DATA:
1. Allows you to review the results from the last cassette
tested.
2. Allows you to enter information into the Risk Assessment
Program.
3. Allows you to change settings in the Conguration Menu.
STOP:
1. Stops a test.
2. Closes the drawer.
3. Allows you to enter and exit the Conguration
Menu of the analyzer.
The drawer will close and the screen will go blank after four
minutes without use.
8 Alere Cholestech LDX®System User Manual
Power Socket,
9V—1A
Connects power
supply to analyzer.
Printer Port
Connects printer
to analyzer.
ROM Pack
Contains upgradable
firmware.
ROM Pack Clip
Cable Support
In the back of the analyzer are two ports: a circular port for the
power supply and a rectangular port used for connecting the
analyzer to a printer. There is also a ROM pack that contains
upgradable rmware. The power supply provides the analyzer
with 9 volts DC at 1 amp. A country-specic power supply is
included.
NOTE: The Alere Cholestech LDX®Analyzer contains a battery
that cannot be replaced by the user. Battery life is greatly reduced
if the analyzer is left unplugged. To conserve this battery, we
recommend plugging in the analyzer when not in use.
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