MICROPOINT qLabs Vet User manual

EN
REF QV-1
Vet
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Table of Contents
1. Introduction....................................................................................3
1.1 Before You Start
1.2 Intended Use
1.3 Test Principle
1.4 Packaging
2. Accessory List...............................................................................5
3. Product Overview..........................................................................5
4. Operation Summary......................................................................7
5. Before Testing................................................................................7
6. Precautions, Limitations and Warnings.......................................8
6.1 Care of Your qLabs®Vet
6.2 Patient Health Status
6.3 Performing a Test
6.4 Collecting Blood Sample
6.5 Electromagnetic Compatibility
7. Powering the qLabs®Vet ON and OFF........................................9
7.1 Power Connection
7.2 Powering the qLabs®Vet On
7.3 Powering the qLabs®Vet Off
8. qLabs®Vet Settings.....................................................................11
8.1 Enter Setup Mode
8.2 Setting the Date
8.3 Setting the Time
8.4 Setting the Normal Range
8.5 Patient ID Setup
8.6 Lot Number Setup
8.7 Selecting Language
9. Perform a Test.............................................................................14
9.1 Entering Test mode
9.2 Insert a Test Strip
9.3 Entering the Patient ID
9.4 Conrming the Patient ID
9.5 Selecting the Species
9.6 Entering the Strip Code and Lot Number (if enabled)
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9.7 After Conrming the Code
9.8 Heating Up
9.9 Getting a Finger stick Sample
9.10 Performing the Test
9.11 Results and Explanation
9.12 Finishing the Test
10. Reviewing Previous Results.......................................................21
10.1 Displaying QC Test Results
10.2 Displaying Patient Test Results
11. Quality Control..............................................................................25
11.1 Onboard QC Tes
11.2 Liquid QC Test
12. Maintenance.................................................................................25
12.1 Care and Cleaning of Your Screen
12.2 Installing/Replacing Batteries
12.3 Maintenance
13. Troubleshooting...........................................................................27
14. Symbols........................................................................................29
15. Performance Characteristics & Product Specications.........30
15.1 Operation Condition
15.2 Product Specications
16. Warranty........................................................................................31
17. Contact Address and Phone Number........................................33
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1. Introduction
1.1 Before You Start
Before using qLabs®Vet, read the User’s Manual carefully.
1.2 Intended Use
The qLabs®Vet is intended for use with qLabs®Vet test strips for in vitro
quantication measurement of a patient’s PT and APTT.
The qLabs®Vet is for veterinary use only.
The qLabs®Vet is validated for use with canine and feline samples
only.
1.3 Test Principle
qLabs®Vet automatically detects the insertion of a qLabs®test strip and
heats the strip to a preset operating temperature. After a drop of blood is
applied to the strip, the capillary channels carry the blood to the reaction
zones, where the blood mixes with pre-printed reagents and starts to
coagulate. Each strip contains two reaction zones. Each reaction zone
contains a pair of metallic electrodes, to which a constant voltage is
applied by the qLabs®Vet. As the coagulation of the blood proceeds, the
current monitored across the two electrodes changes. The qLabs®Vet
detects the change of the current in the test zone and determines the PT
and/or APTT results. The qLabs®Vet and test strips provide APTT, PT
results.
1.4 Packaging
The qLabs®Vet was packed individually.
Upon receipt of package, please open and remove the packaging
materials. Place the qLabs®Vet on a at surface and connect the power
adapter.
Do not keep the qLabs®Vet in direct sunlight, near a high heat source, or
near an area with a strong magnetic eld.
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2. Accessory List
qLabs®Vet includes the following accessories:
• Power Adapter
• User’s Manual
• Quick Start Guide
• Data Manager Installation DVD
• Data Manager Operation Guide
• eCable
NOTES:
• To avoid the possibility of damage, use only the power adapter
supplied with the qLabs®Vet.
• Standard AA batteries can also be used for qLabs®Vet.
• The qLabs®eStation can be purchased separately from Micropoint
Biotechnologies, Inc. Please contact your local distributor for
ordering information.
3. Product Overview
Identication of Components
Front View
1) LCD Screen
2) Returning/Power Button
3) Right Button
4) Left Button
5) OK Button
6) Test Strip Guide
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Back View
1) Battery Cover
2) Battery Cover Screw
3) Battery Cover Release
Top View
1) Power Supply Jack
2) Data Port
Bottom View
1) Barcode Scanner (Laser)
qLabs®Vet Test Strip
1) Electrode Leads
2) Test Zone
3) Sample Well
4) Test Name
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4. Operation Summary
Operation
Preparation
Meter Setup
Performing a Test
Reviewing Previous
Results
Power ON Time Setting
Date Setting Normal Range
Setting
Collect Sample Test Sample
Review QC Data Review Patient Data
Patient ID
Lot Number
Language
Upload Data Print DataDelete Data
Enter Patient ID and
or Strip Lot Number Select Species
5. Before Testing
Before using qLabs®Vet to do a test, you will need:
• qLabs®Vet test strip
• Power supply or batteries
If you are testing fresh venous blood samples, you will also need:
• 21-gauge needle or larger with 1.0 mL syringe
• Sterile alcohol
• Disposable glove
• Puncture-resistant container for medical sharps
• Sterile band aid
• Bio-hazardous container
Or if you are testing citrated whole blood samples, you will also need:
• Eppendorf tube rack
• 200 uL pipette and pipette tips
• Disposable glove
• Sterile alcohol
• Disposable venous blood lanet
• 1.8 or 2.7 mL 3.2% (w/v) sodium citrate venous collection tube
• Bio-hazardous container
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6. Precautions, Limitations and
Warnings
qLabs® Vet is used only for animals in vitro diagnostics.
Before using this system, take special note of CAUTIONS
throughout this User’s Manual.
As with all diagnostic tests, qLabs® Vet’s test results should
be scrutinized in light of a specic patient’s condition and
anticoagulant therapy. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated or
supplemented with additional test data or repeated with
other testing methods.
6.1 Care of Your qLabs®Vet
• The qLabs®Vet is a delicate instrument and should be handled
with care. Dropping or other mishandling may cause malfunction of
qLabs®Vet.
• The qLabs®Vet should be transported in a carrying case or a
secure container.
• DO NOT spill any liquid on the qLabs®Vet. If it happens,
immediately contact local distributor from Micropoint
Biotechnologies, Inc.
• DO NOT store the qLabs®Vet below -10 ºC or above 40 ºC.
• DO NOT use the qLabs®Vet for any other types of test strips not
provided by Micropoint Biotechnologies, Inc.
6.2 Patient Health Status
Current patient health status may cause inaccurate or unexpected test
results. It is important to take certain health factors into consideration
when interpreting the test results and deciding on a course of action for
your patients. Failure to do so may lead to an incorrect interpretation of
the test result.
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6.3 Performing a Test
• The qLabs®Vet should be operated on a level surface that is free
of vibration. Testing on an uneven or unstable surface may cause
inaccurate results. DO NOT hold the qLabs®Vet in your hands
during the testing.
• The blood sample must be applied to the test strip immediately
after collection. Otherwise, the blood sample may begin clotting,
causing inaccurate results.
• DO NOT move or touch the qLabs®Vet during testing.
DO NOT switch power supplier from adapter to battery or
vice versa during testing!
6.4 Collecting Blood Sample
• Use only fresh non anti-coagulated whole blood and citrated whole
blood. Do not use plasma.
• The drop of blood must be a minimum of 10 μL.
• Hematocrit ranges between 30% and 55% will not affect test
results.
6.5 Electromagnetic Compatibility
• This equipment has been tested and found to comply with
applicable EMC emission requirements as specied in EN 61326-1:
2006 and EN 61326-2-6: 2006, immunity to electrostatic discharge
as specied in IEC 61000-4-2, and immunity to radio-frequency
interference at the frequency range and test levels specied in IEC
61000-4-3. The emissions of the energy used are low and not likely
to cause interference in nearby electronic equipment.
• Do not use this instrument in a dry environment, especially if
synthetic materials are present. Synthetic clothes, carpets,
etc., may damage static discharges in a dry environment. That
may cause incorrect operation or damage to the device. The
recommended humidity operating range is 10% to 90%.
• Do not use this instrument near cellular or cordless telephones,
walkie talkies, garage door openers, radio transmitters, or
other electrical or electronic equipment that are sources of
electromagnetic radiation, as these may interfere with the proper
operation of the instrument.
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7. Powering the qLabs®Vet ON and
OFF
7.1 Power Connection
The qLabs®Vet comes with a power supply which must be plugged into
the qLabs®Vet power supply jack. Alternatively, the qLabs®Vet can use 4
standard AA batteries (See Section 12.2).
The messages on the four-cell grid displayed at the
bottom of the screen provide hints for the functions of the
buttons.
7.2 Powering the qLabs®Vet On
OK
NEXT
-+
DD/MM/YY HH:MM
01/02/12
12:00
When the qLabs®Vet is initially powered on,
it will beep and automatically enter Setup
mode. In the Setup mode you can change
the qLabs®Vet settings, or
SET MEM
OFF
VER
Press the “OK” button to view the prompt to
insert a test strip.
When qLabs®Vet is in the standby mode, you have two choices to power
on the monitor:
1) Press and hold the “Power” button for 2 seconds to turn on the
qLabs®Vet, or
2) Insert a fresh test strip if you are ready to perform a test. The
qLabs®Vet will then prompt you to conrm the strip code.
Turning the qLabs®Vet ON in CHOICE 1, allows the user to:
• Perform a test, or
• Check the version of the software and the manufacturer information
by pressing “VER” button, or
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