MICROPOINT qLabs ElectroMeter Q-3 Pro User Manual

MICROPOINT qLabs ElectroMeter Q-3 Pro User Manual

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Q-3 Pro
®
qLabs
ElectroMeter
User's Manual
For Health Care Professional Use Only
A

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Summary of Contents for MICROPOINT qLabs ElectroMeter Q-3 Pro

  • Page 1 Q-3 Pro ® qLabs ElectroMeter User’s Manual For Health Care Professional Use Only...
  • Page 2 Revision History Version Revision Date Changes 2020-04 New Release...
  • Page 3: Table Of Contents

    Table of Contents 1 Introduction ..............1 1.1 Before You Start .............1 1.2 Intended Use ..............1 1.3 Test Principle ..............1 1.4 Packaging ..............1 2 Product Overview ............2 3 Operation Summary ............4 4 Before Testing ..............4 5 Precautions, Limitations and Warnings .......5 ®...
  • Page 4 7.5 Test Parameter .............16 7.5.1 Sample No............16 7.5.2 Codechip............16 7.5.3 Reference Range ..........18 7.5.4 INR Precision ............19 7.5.5 PT Units ............. 19 7.5.6 APTT Units ............20 7.6 System Parameter ............20 7.6.1 Date/Time ............21 7.6.2 Beeper ...............
  • Page 5 9.2 Input Test Strip Information ..........35 9.3 Install Test Strip Codechip ..........35 9.4 Input QC Information ............36 9.5 Install QC Liquid Codechip ...........36 9.6 Heating ................37 9.7 Add Sample ..............38 9.8 QC Test................38 9.9 QC Test Results ............39 10 Results .................41 10.1 Result Channel ............41 10.2 Test Result ..............42 10.3 QC Results ..............43...
  • Page 6: Introduction

    1 Introduction 1.1 Before You Start ® Before using qLabs ElectroMeter, read the User’s Manual as well as the package inserts for all relevant consumables carefully. 1.2 Intended Use ® ® The qLabs monitoring system, which consists of qLabs ElectroMeter ®...
  • Page 7: Product Overview

    2 Product Overview Front View 1.Test Strip Guide 2.Touch Screen Back View 3.Footpad 4.Battery Cover with Label 5.Magnetic Charging Port...
  • Page 8 Left View Right View 6.Power Button 7. Codechip Slot Top View 8.Data Port 9.Power Supply Jack...
  • Page 9: Operation Summary

    3 Operation Summary Operation Preparation Bluetooth Sample No. Reference Language PT Units APTT Units WIFI Switch Switch Codechip Range Precision Setting Setting Setting Setting Setting Setting Setting Meter Setup Date/Time Beeper Backlight Screen Sleep Upload/Print Transport Operator ID Mode Setting Setting Setting Rotation...
  • Page 10: Precautions, Limitations And Warnings

    ® • DO NOT spill any liquid on the qLabs ElectroMeter. If this should occur, immediately contact your local distributor from Micropoint Biotechnologies Co., Ltd. ® • DO NOT store the qLabs ElectroMeter below -10 ºC or above 40 ºC.
  • Page 11: Performing A Test

    5.3 Performing a Test ® • The qLabs ElectroMeter 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 in your hands during the testing. •...
  • Page 12: Collect Fresh Venous Whole Blood Samples

    5.5 Collect fresh venous whole blood samples • Use a syringe at least 1 ml to puncture a vein to collect fresh venous whole blood. • Avoid repeated use of the same syringe for puncture acquisition. • Do not use syringe with anti-coagulants (e.g., EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample.
  • Page 13: Warning Information On Built-In Lithium Battery

    • The user must use the matching 5V special charger provided by Micropoint to charge. • Do not bring the meter close to a high-temperature heat source. • Do not allow the meter to be hit or exert heavy pressure on the meter.
  • Page 14: Power On/Off

    6 Power On/Off 6.1 Battery and Charging When turning on the meter for the first time after unpacking, please connect the adapter for power supply and turn off the transportation mode. You do not need to repeat this operation for subsequent reboot. Ensure the meter is fully charged before using for the first time.
  • Page 15: Sleep Mode

    Once Operator ID is On, the Log out icon in Main screen will be enabled and displayed in brown (see figure 2-2). To switch between the operators, please return to the screen for inputting the operator ID by pressing the Log out icon, and then re-enter the operator ID.
  • Page 16: Power Off

    6.4 Power Off After a press of the Power button for 3 seconds, the system will deliver a message to select. Press " " to power off the instrument, or press " " to cancel the operation (see figure 2-4). When the battery power of the meter is exhausted, it will automatically shut down.
  • Page 17: Settings

    7 Settings 7.1 Enter Settings Screen Click the "Settings" icon from the main menu screen (Figure 2-2) to enter the Settings screen (Figure 3-1). (3-1) 7.2 Language Click "Language" from the Settings screen (Figure 3-1) to enter the screen that prompts the user to select a language (Figure 3-2).
  • Page 18 Click “WIFI” from Settings menu (see Figure 3-1) to enter the WIFI menu (see Figure 3-3). When the WIF button is displayed in blue, it means WIFI is turned on; when the WIFI button is grayed out, it means WIFI is turned off.
  • Page 19: Bluetooth

    The loss of signal or access to bandwidth of one particular client may vary depending on one or more of the following situations: the type and num- ber of other clients, the performance of the Access Point, the presence of electromagnetic disturbances, and other potential interfering factors, e.g., concrete walls.
  • Page 20 II for printing. The test results can also be transferred to DMS, LIS or HIS system via eStation II. After connecting with a specific mobile APP, Micropoint cloud can be accessed to upgrade and maintain the meter’s software when necessary.
  • Page 21: Test Parameter

    7.5 Test Parameter Click "Test Parameter" from the Setting screen (Figure 3-1) to enter the screen (Figure 3-10) that prompts the user to set the parameters. (3-10) 7.5.1 Sample No. Click "Sample No." from the Test Parameter screen (Figure 3-10) to enter the screen (Figure 3-11) that prompts the user to set the sample No.
  • Page 22 Click “Test Strip” from Codechip menu (see figure 3-12) to enter Test Strip menu (see figure 3-13). The Codechip information of the installed strip then displayed in this menu. A new strip Codechip can also be installed by inserting the strip Codechip into the Codechip slot (see the right figure on Section 2 Product Overview).
  • Page 23: Reference Range

    In addition to being installed from Codechip menu, a Codechip can also be installed during the test. When testing with a test strip or control with a Codechip installed, the installation operation is no longer required during the test; otherwise, the system enter the prompt menu which enables the user to install the desired Codechip accordingly.
  • Page 24: Inr Precision

    Click any value in the Reference Range table to automatically enter the menu which allow the user to modify the value, and the user can re-modify the upper and lower limits (see figure 3-16) within the given setting range. After the value range is modified, if the test result is below the lower limit, "...
  • Page 25: Aptt Units

    APTT mean based on local clinical results to obtain an accurate ratio. The normal APTT mean is 36 by default, which is determined by Micropoint based on parallel tests of 20 healthy individuals. 7.6 System Parameter Click "System Parameter" from...
  • Page 26: Date/Time

    7.6.1 Date/Time Click "Date/Time" from the System Parameter screen (Figure 3-20) to enter the screen (Figure 3-21) that prompts the user to set the date and time. The user can set the date, time, and even their display format respectively. Click " "...
  • Page 27: Screen Rotation

    7.6.3 Screen Rotation Press the "Screen Rotation" from the System Parameter screen (Figure 3-20) to enter the screen for selecting screen rotation (Figure 3-23). Change the settings and rotate the screen for 180°, then the text direction is adjusted automatically. The test strip is inserted from the lower part by default.
  • Page 28: Print And Upload

    7.6.6 Print and Upload Click "Auto Print/Upload" from the System Parameter screen (Figure 3-20) to enter the print upload setting screen (Figure 3-26). The auto print/upload function is disabled when the button is grayed out. The auto print/upload function is enabled when the button is blue. Click "...
  • Page 29: About The Device

    7.7 About the Device Click "About the Device" from Settings screen (Figure 3-1) to enter the screen that displays the system information (Figure 3-28). The user can check the version and log information. Click " " to return to the previous screen and click " "...
  • Page 30 After touching "User Management" from the operator ID screen (Figure 3-29), the administrator can enter the screen and view the created user list (Figure 3-30). To create a new user account, please touch " " at the bottom of the screen. The number of user accounts should not exceed 50.
  • Page 31 If the administrator forgets the password, please contact the local distributor or relevant technicians of Micropoint. (3-32) The user can log in to any existing account from the Login screen. Enter the correct password and log into the screen to perform the relevant operation.
  • Page 32: Sample Test

    8 Sample Test 8.1 Input Sample No. When the sample No. switch is turned off, skip the step of inputting the sample No. and insert the test strip directly. When the sample number switch is turned on, the sample can be numbered manually or automatically.
  • Page 33: Input Test Strip Information

    8.3 Input Test Strip Information After the test strip is inserted, please enter the test strip information screen (Figure 4-3), and input the Codechip number of the test strip, the Codechip number can be inputted through manually input and click " "...
  • Page 34: Heating

    When the input Codechip number of the test strip does not match the Codechip information, the system will deliver a warning message indicating that the Codechip information does not match. When the input Codechip number of the test strip has expired, the system will deliver a warning message indicating that the Codechip has expired.
  • Page 35: Add Sample

    8.6 Add Sample The system will count down and prompt the user to add sample (Figure 4-6) upon the completion of heating, and the sample must be added within 120 seconds. Do not move the instrument or your fingers during sample adding. If the sample is not added properly within 120 seconds, the system will deliver an error message indicating sample...
  • Page 36 3. Clean the selected area with 70% isopropyl alcohol, or an alcohol pad. Dry thoroughly with cotton or gauze. 4. Puncture the finger following the instructions for the lancet that you are using. 5. Apply gentle, continuous pressure until a large, hanging drop of blood forms.
  • Page 37: Perform A Test

    NOTES: Do not exceed 30 seconds from venipuncture to adding blood sample. 8.7 Perform a Test After the sample is added properly, the system will start the test automatically and display the test progress (Figure 4-7). Do not perform other operations during testing.
  • Page 38: Test Results

    8.8 Test Results Please check the strip insert for the results and explanation. The system will display the test results after the test is completed (Figure 4-8). The test results can be printed or uploaded, provided that the instrument is properly connected to the printer or server.
  • Page 39: Quality Control

    Failure of Quality Control test will result in the instrument displaying an error code. Please repeat the test utilizing a new test strip. • Liquid QC Test Micropoint Biotechnologies Co., Ltd. has optional liquid controls for qLabs system. The qLabs...
  • Page 40: Input Test Strip Information

    9.2 Input Test Strip Information After the test strip is inserted, please enter the test strip information screen (Figure 5-2), and input the Codechip number of the test strip, the Codechip number can be inputted through manually input and click " "...
  • Page 41: Input Qc Information

    When the input Codechip number of the test strip has expired, the system will provide a warning message indicating that the Codechip has expired. 9.4 Input QC Information After the Codechip is installed, please enter the QC information screen (Figure 5-4), and input the Codechip number of the QC liquid (see the outer package for details), The Codechip number can be...
  • Page 42: Heating

    When the input Codechip number of QC liquid does not match the Codechip information, the system will provide a warning message indicating that the Codechip information does not match. When the input Codechip number of QC liquid has expired, the system will provide a warning message indicating that the Codechip has expired.
  • Page 43: Add Sample

    9.7 Add Sample The system will count down and prompt the user to add sample (Figure 5-7) upon the completion of heating, and the sample must be added within 120 seconds. Please strictly follow the requirements of the QC liquid insert during sample adding.
  • Page 44: Qc Test Results

    9.9 QC Test Results The system will display the QC test results after the test is completed (Figure 5-9). The test results can be printed or uploaded, provided that the instrument is properly connected to the printer or server. (5-9) From Query Result screen (Figure 5-9), touch "Remarks"...
  • Page 45 If the test strip has not been removed after the QC test is completed, please click " " from the test result screen to go to the strip removal screen (Figure 5-11), and remove the test strip in the direction shown in the figure. If the test strip is removed from the test result screen after the QC test is finished, the screen will directly jump...
  • Page 46: Results

    10 Results When the storage amount of the sample result reaches 80% of the total amount of the meter, the user will be prompted to upload data. If the user does not upload the data, the sample results will automatically overwrite the oldest records after the total amount exceeds the limit.
  • Page 47: Test Result

    10.2 Test Result Click "Test Result" from the result screen (Figure 6-1) to enter the test result query screen (Figure 6-3). If there are multiple test results, please scroll through the display for all results. Click " " in the test result screen to clear all test results.
  • Page 48: Qc Results

    10.3 QC Results Click "QC Test" Result from the result screen (Figure 6-1) to enter the QC test result query screen (Figure 6-5). If there are multiple QC test results, please scroll through the display to list all results. Click "...
  • Page 49: Maintenance

    11 Maintenance ® 11.1 Care and Cleaning of Your qLabs ElectroMeter Follow these steps for cleaning the qLabs ElectroMeter: ® 11.1.1 Cleaning Frequency 1. Clean the meter after every patient and when there are signs of visible soil and/or organic material prior to disinfecting. Also follow any facility disinfection SOPs.
  • Page 50 11.1.4 Recommended cleaning/disinfecting solutions 1. Disposable wipes containing a quaternary ammonium compound up to 0.5% (single compound or mixture) in isopropyl alcohol up to 55%. 2. Do not use other disinfectants or cleaning solutions on the meter. 3. Recommended cleaning cloths are listed in table 1. 4.
  • Page 51: Precautions For Lithium-Ion Battery

    When stored for more than 3 months, it is recommended to turn on the transportation mode after charging every 3 months to avoid battery discharge and capacity attenuation. 11.3 Servicing No user serviceable components. All service and adjustment must be performed by Micropoint Biotechnologies Co., Ltd.
  • Page 52: Troubleshooting

    12 Troubleshooting When you receive an error code, please retest. If you receive a second error code, then contact your local distributor and test the patient with a laboratory method. Do not interpret an error code as a patient result in any case. CORRECTIVE ERROR CODE DESCRIPTION...
  • Page 53 CORRECTIVE ERROR CODE DESCRIPTION ACTIONS Please retest with a new test INR result is out of range, or strip. If the problem recurs, E009 sample may not be suitable for please contact your local dealer qLabs testing. and use the laboratory method to perform the test.
  • Page 54 CORRECTIVE ERROR CODE DESCRIPTION ACTIONS Please adjust the ambient temperature to 10 °C ~ 35 °C, and turn off the meter for The temperature of the meter E019 5 minutes, then turn on the is too high. meter and restart the test. If the problem recurs, please contact the relevant technical staff.
  • Page 55: Symbols

    13 Symbols SYMBOLS EXPLANATION SYMBOLS EXPLANATION In Vitro Expiry Date Diagnostics Caution. Read Fragile Carefully Keep Dry Biological Risk Separate Do Not Reuse Collection Temperature Manufacturer Limitation Authorized Consult Representative Instructions For in the European Community Catalogue Serial Number Number CE Marking Lot Number...
  • Page 56: Operating Condition And Product Specifications

    14 Operating Condition and Product Specifications 14.1 Operating Condition Temperature 10ºC ~ 35ºC / 50ºF ~ 95ºF Humidity 10% ~ 90% (No condensation) Maximum altitude 4300 m (14,000 feet) 14.2 Product Specifications Processor 32-bit ARM Cortex-M4 Display 320mm×480mm LCD Touch screen Capacitive touch screen Stores up to 2,000 patient records Memory...
  • Page 57: Special Storage Conditions And Methods

    Micropoint Biotechnologies Co., Ltd.’s only liability and purchaser’s only remedy under this warranty is that during the warranty period Micropoint Biotechnologies Co., Ltd. shall replace or repair, at no charge, any Meter component with defects in material or workmanship. MICROPOINT BIOTECHNOLOGIES CO., LTD. MAKES NO OTHER...
  • Page 58 IN CONNECTION WITH THE METER, REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE METER. IN NO EVENT WILL MICROPOINT BIOTECHNOLOGIES CO., LTD. BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, CONSEQUENTIAL, OR PUNITIVE LOSS OR DAMAGES IN ANY WAY RELATED TO THE METER, OR ANY THIRD PARTY.
  • Page 59 Fax: +32 2 732 60 03 Fax : +86 755 86673903 www.obelis.net E-mail : customerservice@micropointbio.com www. micropointbio.com ©2020 Micropoint Biotechnologies Co., Ltd. All rights reserved. Printed in China. qLabs and Micropoint are registered trademarks of Micropoint Biotechnologies Co., Ltd. ®...

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