MICROPOINT qLabs ElectroMeter Plus Manual de usuario
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REF Q-2 Plus
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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. OperationSummary........................................................................7
5. Before Testing.................................................................................7
6. Precautions, Limitations and Warnings.........................................8
6.1 Care of Your qLabs®ElectroMeter Plus
6.2 Patient Health Status
6.3 Performing a Test
6.4 Collecting a Finger Stick Blood Sample
6.5 Electromagnetic Compatibility
7. Powering the qLabs®ElectroMeter Plus ON and OFF...............10
7.1 Power Connection
7.2 Powering the qLabs®ElectroMeter Plus On
7.3 Powering the qLabs®ElectroMeter Plus Off
8. qLabs®ElectroMeter Plus Settings.............................................12
8.1 Enter Setup Mode
8.2 Setting the Date
8.3 Setting the Time
8.5 Patient ID Setup
8.6 QC Lockout Setup
8.7 Selecting Language
9. Perform a Test..............................................................................15
9.1 Entering Test mode
9.2 Insert a Test Strip
9.3 Entering the Patient ID
9.3.1 Manual Input
9.3.2 Auto Scan
9.4 Confirming the Patient ID
9.5 Entering the Strip Code
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9.5.1 Manual Input
9.5.2 Auto Scan
9.6 Confirming the Code
9.7 Heating Up
9.8 Getting a Finger stick Sample
9.9 Performing the Test
9.10 Results and Explanation
9.11 Finishing the Test
10. Reviewing Previous Results.........................................................22
10.1 Displaying QC Test Results
10.2 Displaying Patient Test Results
10.3 Deleting Patient Test Results
10.4 Printing Patient Test Results
11. Quality Control..............................................................................25
11.1 Onboard QC Test
11.2 Liquid QC Test
12. Maintenance.................................................................................26
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 Specifications.............30
15.1 Operation Condition
15.2 Product Specifications
16. Warranty........................................................................................31
17. Contact Address and Phone Number..........................................33
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1. Introduction
1.1 Before You Start
Before using qLab®ElectroMeter Plus, read the entire User’s Manual
carefully.
1.2 Intended Use
The qLabs®ElectroMeter Plus is intended for use with qLabs®Coag Panel
2 test strips for in vitro quantification Prothrombin Time (PT)/International
Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT).
Blood normally clots to slow down the flow of the blood in response to
the damage of blood vessels, in order to prevent excessive bleeding. A
clot formed inappropriately in the areas of heart, lung and brain, however,
can hinder normal blood flow and may result in life-threatening events
such as stroke and heart attack. For patients who lose their ability to
properly reabsorb clots and patients who have low tolerance to clots,
anticoagulation medicine (blood thinner) is prescribed. Because these
medications may have narrow therapeutic windows and be sensitive to
diet and lifestyle, it may be necessary for patients to adjust their dosage
regularly. In order to make good decisions regarding the need for such
an adjustment, it is important for the patient to know the clotting status
of their blood. A quick and accurate measurement of clotting capacity is
critical for the safety and effectiveness of the anticoagulation therapy.
The PT is an extrinsic coagulation pathway, which is commonly used
for monitoring vitamin K antagonist therapy because of its sensitivity to
variations in the concentration of the vitamin K dependent factors II, VII
and X. While PT times may vary depending on the test method used, INR
values should be the same regardless of the method used. International
Normalized Ratio (INR) is recommended by WHO to remove dependence
on reagent and test method. The qlabs®ElectorMeter calculates the PT
value based on an analysis of the test data, and then converts this to the
correct INR value.
The APTT is a general coagulation test used for screening and measuring
the functionality of the intrinsic coagulation pathway, which involves the
coagulation factor XII, XI, IX, VIII, X, V, II and fibrinogen. It is also used to
monitor the effectiveness of heparin therapy. The APTT is a modification of
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the Partial Thromboplastin Time (PTT). It can provide a more precise and
sensitive assay.
Micropoint Biotechnologies, Inc. provides various combinations of the
above tests in one strip, including:
• PT/INR Test Strips
• APPT Test Strips
• PT/APTT combo Test Strips
1.3 Test Principle
qLabs®ElectroMeter Plus automatically detects the insertion of a
qLabs®Coag Panel 2 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®ElectroMeter Plus.
As the coagulation of the blood proceeds, the current monitored across
the two electrodes changes. The qLabs®ElectroMeter Plus detects the
change of the current in the test zone and determines the PT and/or APTT
results. The qLabs®ElectroMeter Plus and test strips provide APTT, PT
and INR results.
1.4 Packaging
The qLabs®ElectroMeter Plus was packed individually.
Upon receipt of package, please open and remove the packaging
materials. Place the qLabs®ElectroMeter Plus on a flat surface and
connect the power adapter.
Do not keep the qLabs®ElectroMeter Plus in direct sunlight, near a high
heat source, or near an area with a strong magnetic field.
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2. Accessory List
qLabs®ElectroMeter Plus includes the following accessories:
• Power Adapter
• User’s Manual
• Carrying Case
• Lancet Device
• Instructional DVD
• Quick Start Guide
• Data Manager Installation DVD
• Data Manager Operation Guide
• eCable
NOTE:
• To avoid the possibility of damage, use only the power adapter
supplied with the qLabs®ElectroMeter Plus.
• Standard AA alkaline batteries can also be used for qLabs®
ElectroMeter Plus.
• The qLabs®eStation can be purchased separately from Micropoint
Biotechnologies, Inc. Please contact your local distributor for ordering
information.
3. Product Overview
Identification 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®Coag Panel 2 Test Strip
1) Electrode Leads
2) Test Zone
3) Sample Well
4) Test Name
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4. Operation Summary
5. Before Testing
Before using qLabs®system to do a test, you will need:
• qLabs®Coag Panel 2 test strip
• Power supply or batteries
• Alcohol wipes
• Gauze and Band-Aid
• Lancet device
• Puncture proof container
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6. Precautions, Limitations and
Warnings
qLabs®blood coagulation testing system is intended for in
vitro diagnostics use only. Before using this system, take
special note of CAUTIONS throughout this User’s Manual.
6.1 Care of Your qLabs®ElectroMeter Plus
• The qLabs®ElectroMeter Plus is a delicate instrument and should
be handled with care. Dropping or other mishandling may cause
malfunction of qLabs®ElectroMeter Plus.
• The qLabs®ElectroMeter Plus should be transported in a carrying
case or a secure container.
• DO NOT spill any liquid on the qLabs®ElectroMeter Plus. If this
should occur, immediately contact local distributor from Micropoint
Biotechnologies, Inc.
• DO NOT store the qLabs®ElectroMeter Plus below -10 ºC or above
40 ºC.
• DO NOT use the qLabs®ElectroMeter Plus 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.
6.3 Performing a Test
• The qLabs®ElectroMeter Plus 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®ElectroMeter Plus
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.
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• Plasma samples or whole blood samples with anticoagulation
reagents are not suitable for the qLabs®Coag Panel 2 test.
• DO NOT move or touch the qLabs®ElectroMeter Plus during testing.
DO NOT switch power supplier from adapter to battery or
vice versa during testing!
6.4 Collecting a Finger Stick Blood Sample
• Sanitize the site of the nger stick with alcohol wipe before testing.
• Use fresh capillary nger stick blood sample for testing.
• Squeezing the nger stick site excessively (milking) may release
interstitial fluid into the blood sample, which may lead to inaccurate
results.
• The site of the nger stick must be completely dry. If any alcohol
remains on the finger, it may cause hemolysis, which may lead to
inaccurate results.
6.5 Electromagnetic Compatibility
• This equipment has been tested and found to comply with applicable
EMC emission requirements as specified in EN 61326-1: 2006 and
EN 61326-2-6: 2006, immunity to electrostatic discharge as specified
in IEC 61000-4-2, and immunity to radio-frequency interference
at the frequency range and test levels specified 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
cause damaging static discharges in a dry environment. That may
cause incorrect operation or damage to the device.
• 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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