MICROPOINT qLabs ElectroMeter Plus User Manual
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  • Page 1 REF Q-2 Plus Plus qLabs.ElectroMeter.manual.Q-2 Plus.indd 1 2/12/2014 6:16:27 PM...
  • Page 2: Table Of Contents

    Table of Contents Introduction..................3 1.1 Before You Start 1.2 Intended Use 1.3 Test Principle 1.4 Packaging Accessory List................5 Product Overview................5 Operation Summary................7 Before Testing.................7 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...
  • Page 3 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...
  • Page 4: Introduction

    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).
  • Page 5: Test Principle

    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...
  • Page 6: Accessory List

    ® • 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...
  • Page 7 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 qLabs.ElectroMeter.manual.Q-2 Plus.indd 6...
  • Page 8: Operation Summary

    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 •...
  • Page 9: Precautions, Limitations And Warnings

    • 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 ®...
  • Page 10: Collecting A Finger Stick Blood Sample

    • 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 •...
  • Page 11: Powering The Qlabs

    7. Powering the qLabs ElectroMeter ® Plus ON and OFF 7.1 Power Connection The qLabs ElectroMeter Plus comes with a power supply which must ® be plugged into the qLabs ElectroMeter Plus power supply jack. ® Alternatively, the qLabs ElectroMeter Plus can use 4 standard AA ®...
  • Page 12: Powering The Qlabs ® Electrometer Plus Off

    • Check the version of the software and the manufacturer information by pressing OK button, or V7.0.01 MICROPOINT 033200F0200009 • Enter Setup mode by pressing “SET” button to change the ElectroMeter Plus setting, or • Enter Memo mode by pressing “MEM” button to review previous results.
  • Page 13: Qlabs ® Electrometer Plus Settings

    8. qLabs ElectroMeter Plus Settings ® Follow the steps below to change the date, time, and a target range for your INR results. 8.1 Enter Setup Mode When the qLabs ElectroMeter Plus is turned ® on for the first time, it will automatically enter to the Setup Mode.
  • Page 14: Setting The Time

    8.3 Setting the Time The time is in 24-hour format: “HH:MM” (Hour: Minute). After the day setting, the setting option will prompt you to the hour setting mode. The hour will be highlighted on the display. Use “+” and “-” functional buttons to adjust the hour.
  • Page 15: Selecting Language

    NOTE: • To make sure the QC lockout function goes right, please keep the meter’s built-in timer working. Just set up the time when the meter was initially powered on and keep either adapter or battery power supply uninterrupted. Interruption in power supply will reset the timer. •...
  • Page 16: Perform A Test

    9. Perform a Test 9.1 Entering Test Mode When the qLabs ElectroMeter Plus is ® turned on by pressing the “OK” button, the display screen will prompt the user to insert a test strip. Go to Section 9.2 for test strip insertion.
  • Page 17: Entering The Patient Id

    9.3 Entering the Patient ID The Patient ID can be composed of numbers or letters, with a length of no more than 14 digits. The Patient ID can be entered either via user’s manual input or the built-in barcode scanner. 9.3.1 Manual Input Use “+”...
  • Page 18: Entering The Strip Code

    9.5 Entering the Strip Code ENTER CODE The Strip Code can be entered either via User’s Manual input or the built-in barcode PT/APTT scanner. 471022636 NEXT NOTE: • The Strip Code contains information of the type of test. After you entered the Strip Code, the test name will be recognized automatically and displayed on the screen.
  • Page 19: Auto Scan

    9.5.2 Auto Scan User can also use the built-in barcode scanner to scan the Strip Code on the pouch. 9.6 Confirming the Code CONFIRM If the Strip Code is entered correctly, press PT/APTT “OK” button to confirm the code. 471022636 Otherwise, press “BACK”...
  • Page 20: Getting A Fingerstick Sample

    9.8 Getting a Fingerstick Sample Good finger stick technique is beneficial to both the professional user and the patient. Getting a good finger stick will ensure minimal discomfort for the patient and accurate test results for the user. 9.8.1 Maximize Good Blood Circulation 1) If needed, briefly warm the hand in warm water or with a heating 2) Massage the finger with a downward motion several times before performing the fingerstick...
  • Page 21: Performing The Test

    9.9 Performing the Test Make sure to apply the blood sample directly on the sample well of the strip. DO NOT move the qLabs ElectroMeter Plus while ® adding the blood to the strip. After the blood sample is added, the qLabs ®...
  • Page 22: Results And Explanation

    20.1 Page = 6 When testing is complete, the qLabs ® 48.1 APTT 16:26 ElectroMeter Plus will beep and the test 00005 results will appear on the screen along with the patient ID and test time. MENU If the test results need to be reported instantly, press “MENU”...
  • Page 23: Reviewing Previous Results

    Plus when it is not in use. 20.1 Page = 6 48.1 APTT 16:26 Before turning off the meter, press the “ ” 00005 button to return to the test mode. MENU Remove the test strip from the meter. To perform another test, please use a fresh test strip.
  • Page 24: Displaying Qc Test Results

    10.1 Displaying QC Test Results The meter stores up to 12 QC results chronologically. The most recent result is named “N-1”. The least recent result is named “N-12”. Press the “+” and “-” buttons to switch between QC result. Press “ ”...
  • Page 25: Printing Patient Test Results

    In the REMOVE/PRINT interface, press the “ ” to enter delete setting interface. Use “+” and “-“ buttons to toggle between deleting all results or the current result. Press the “OK” button to confirm or press “ ” button to exit. If the option to delete the current result is selected, the “DELETED!”...
  • Page 26: Quality Control

    ® temperatures or humidity (which could happen if the foil pouch is torn or punctured). 11.2 Liquid QC Test Micropoint Biotechnologies, Inc. has optional liquid controls for qLabs ® PT-INR system. The qLabs PT-INR and APTT liquid controls are used ®...
  • Page 27: Maintenance

    • If storing the ElectroMeter Plus for an extended period, completely remove the batteries before the next use. Dispose of the batteries in compliance with local regulations. 12.3 Servicing All servicing and adjustment must be performed by Micropoint Biotechnologies, Inc.’s service engineers only. qLabs.ElectroMeter.manual.Q-2 Plus.indd 26 2/12/2014 6:17:40 PM...
  • Page 28: Troubleshooting

    13. Troubleshooting CORRECTIVE ERROR CODE DISCRIPTION ACTIONS If you have already applied ADD BLOOD the blood sample and this DO NOT add more blood to message continues for longer the test strip. Repeat the test than 30 seconds, it indicates with a fresh test strip and a that not enough blood has fresh drop of blood.
  • Page 29 CORRECTIVE ERROR CODE DISCRIPTION ACTIONS 1. Make sure the strip is within the expiry date. Internal QC check out of E005 2. Make sure the Strip Code specifications. is entered correctly. 3. Retest with a new strip. 1. Make sure the strip and liquid controls are within the expiry date.
  • Page 30: Symbols

    14. Symbols SYMBOLS EXPLANATION SYMBOLS EXPLANATION In Vitro Expiry Date Diagnostics Caution. Read Fragile Carefully Avoid Liquid Biological Risk Spills Separate DO Not Reuse Collection Temperature Manufacturer Limitation Authorized Consult Representative Instructions For in the European Community Catalog Serial Number Number CE Mark Lot Number...
  • Page 31: Performance Characteristics & Product Specifications

    15. Performance Characteristics & Product Specifications 15.1 Operation Condition between 10ºC and 35ºC (50ºF Temperature and 95ºF) Humidity 10% and 90% Atmospheric Pressure 700 hPa and 1060 hPa 15.2 Product Specifications 32 V1 ColdFire Display screen 128×96 LCD Test memory 200 test results Laser Class 2, according to EN Barcode scanner...
  • Page 32: Warranty

    Micropoint Biotechnologies, Inc.’s only liability and purchaser’s only remedy under this warranty is that during the warranty period Micropoint Biotechnologies, Inc. shall replace or repair, at no charge, any Meter component with defects in material or workmanship. MICROPOINT BIOTECHNOLOGIES, INC.
  • Page 33 IF MICROPOINT BIOTECHNOLOGIES, INC. OR ITS DISTRIBUTORS ARE AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES AND NOTWITHSTANDING THE ESSENTIAL PURPOSE OF ANY REMEDY. qLabs.ElectroMeter.manual.Q-2 Plus.indd 32 2/12/2014 6:17:50 PM...
  • Page 34: Contact Address And Phone Number

    Customer Service and Technical Support Available 8:30 AM to 5:30 PM (Beijing Standard Time), Monday-Friday. Tel: +86 755 86296766 Micropoint Biotechnologies, Inc. 6F, No.3, Industry 5 Road, Shekou, Shenzhen, Guangdong 518067, China Tel: +86 755 86296766 Fax: +86 755 86673903 www.micropointbio.com...
  • Page 35 P/N MP320401 Rev.A1 qLabs.ElectroMeter.manual.Q-2 Plus.indd 34 2/12/2014 6:17:54 PM...

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