Table of Contents 1 Introduction ..................... 4 1.1 Before You Start ..................4 1.2 Intended Use .................... 4 1.3 Test Principle ................... 4 1.4 Packaging ....................4 2 Product Overview ................... 5 3 Operation Summary ..................7 4 Before Testing ....................
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7.5.7 Transport Mode ............... 23 7.6 About the Device ................... 24 7.7 Operator ID .................... 24 8 Sample Test ....................26 8.1 Input Sample No..................26 8.2 Insert a Test Strip ................... 26 8.3 Input Test Strip Information ..............27 8.4 Install Codechip ..................
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14 Operating Condition and Product Specifications ........51 14.1 Operating Condition ................51 14.2 Product Specifications ................ 51 15 Special storage conditions and methods ............. 52 16 Warranty ...................... 52...
1 Introduction 1.1 Before You Start Before using the qLabs ElectroMeter to test Prothrombin Time (PT) , ® International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT), read the entire User’s Manual carefully. 1.2 Intended Use The qLabs monitoring system is used for quantitative measurement of ®...
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Front View 1.Test Strip Guide 2.Touch Screen Back View 3.Footpad 4.Battery Cover 5.Magnetic Charging Port...
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Left View Right View 6.Power Button 7. Codechip Slot Top View 8.Data Port 9.Power Supply Jack...
3 Operation Summary 4 Before Testing Before using the qLabs monitoring system to do a test, you will need: ® • qLabs Test Strips ® • Power supply • Puncture proof container Testing fi ngerstick blood sample: • Alcohol Pads and Gauze •...
• 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 ®...
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.
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.
6 Power On/Off 6.1 Power On When the instrument is turned on for the first time, the battery must be fully charged. If the battery is running low, please don’t turn on the instrument until the power adapter provided with the instrument is inserted into the power jack and connected to the external power supply.
IIf Operator ID is Off, the Log out icon in Main screen will be disabled and grayed out (see figure 2-3), and the meter then directly enters the Main screen after it is turned on. (2-3) 6.2 Power Off Press and hold the Power button for 1 second to turn it off. If auto sleep function is enabled, the meter will automatically shut down after the idle time reaches the sleep waiting time.
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).
7.3 Bluetooth Click “Bluetooth” from Settings menu (see fi gure3-1) to enter the Bluetooth menu (see fi gure 3-3). When the Bluetooth button is displayed in blue, it means Bluetooth is turned on; when the Bluetooth button is grayed out, it means Bluetooth is turned off.
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II for printing. The test results can also be transferred to DMS, LIS or HIS system via eStation II. After connecting with a specifi c mobile APP, Micropoint cloud can be accessed to upgrade and maintain the meter’s software when necessary.
7.4 Test Parameter Click "Test Parameter" from the Setting screen (Figure 3-1) to enter the screen (Figure 3-7) that prompts the user to set the parameters. (3-7) 7.4.1 Sample No. Click "Sample No." from the Test Parameter screen (Figure 3-7) to enter the screen (Figure 3-8) that prompts the user to set the sample No.
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Click “Test Strip” from Codechip menu (see fi gure 3-9) to enter Test Strip menu (see fi gure 3-10). 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 fi gure on P6).
the test; otherwise, the system enter the prompt menu which enables the user to install the desired Codechip accordingly. The Codechip provides the meter with important information that it needs to perform the coagulation test. The chip contains information about the test strip code, the lot number, and the expiration date.
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 fi gure 3-13) within the given setting range. After the value range is modifi ed, if the test result is below the lower limit, "...
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. 7.5 System Parameter Click "System Parameter" from...
7.5.1 Date/Time Click "Date/Time" from the System Parameter screen (Figure 3-17) to enter the screen (Figure 3-18) that prompts the user to set the date and time. The user can set the date, time, and even their display format respectively. Click " "...
7.5.3 Screen Rotation Press the "Screen Rotation" from the System Parameter screen (Figure 3-17) to enter the screen for selecting screen rotation (Figure 3-20). 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.
7.5.6 Print and Upload Click "Auto Print/Upload" from the System Parameter screen (Figure 3-17) to enter the print upload setting screen (Figure 3-23). 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.
7.6 About the Device Click "About the Device" from Settings screen (Figure 3-1) to enter the screen that displays the system information (Figure 3-25). The user can check the version and log information. Click " " to return to the previous screen and click " "...
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Click “Change Password” from Operator ID menu (see fi gure 3-26) to enter the Change Password menu (see fi gure 3-27). To change password, please enter Current Password and New Password, then enter New Password again to confi rm the password. If the password is forgotten, please contact your local dealer or the relevant technical staff.Click "...
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.
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 " "...
8.4 Install Codechip Insert the test strip Codechip into the chip slot (see Section 1.3 for position details), then the specific Codechip information will display (Figure 4-4). (4-4) When the input Codechip number of the test strip does not match the Codechip information, the system will deliver a warning message i n d i c a t i n g t h a t t h e C o d e c h i p...
8.5 Heating After the test strip is inserted and its Codechip is installed, the instrument will enter the heating state, and the screen will display the heating progress (Figure 4-5). (4-5) 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...
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heating pad. 2) Massage the finger with a downward motion several times before performing the fingerstick. 3) Lower the hand to below the heart level when collecting the blood drop. 2. Identify a site on the finger to puncture 1) On one of the middle fingers of either hand.
8.6.2 Collect fresh venous whole blood samples 1. Clean the venipuncture site with alcohol and allow it to air-dry completely. 2. Collect > 0.1 mL of venous blood into 1.0mL syringe. 3. Discard the fi rst four drops of blood collected. Then immediately apply one drop of blood (at least 10 μL) directly onto the strip for testing.
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.
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If the test strip has not been removed after the test is completed, please click " " from the test result screen to go to the strip removal screen (Figure 4-10), and remove the test strip in the direction shown in the fi gure. If the test strip is removed from the test result screen after the test is fi nished, the screen will directly jump to the Main...
The qLabs PT-INR and APTT liquid controls can be purchased separately ® from Micropoint Biotechnologies Co., Ltd. Please refer to the qLabs ® PT-INR and APTT liquid controls package insert for detailed operation instructions.
9.2 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 " "...
When the input Codechip number of the test strip has expired, the system will provide a war ning m e s s a g e i n d i c a t i n g t h a t t h e Codechip has expired.
When the input Codechip number of QC liquid does not match the Codechip information, the system will provide a warning message i n d i c a t i n g t h a t t h e C o d e c h i p information does not match.
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.
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 "Comment"...
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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 fi gure. If the test strip is removed from the test result screen after the QC test is fi nished, the screen will directly jump...
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.
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.
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 "...
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 Clean the meter after every patient and when there are signs of visible soil and/or organic material prior to disinfecting.
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excess solution before wiping the surface of the meter. 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.
Fully charge the meter prior to storage or extended non-usage. For storage greater than three months, recommend recharge every three months to avoid battery capacity discharge and decay. 11.3 Servicing No user serviceable components. All service and adjustment must be performed by Micropoint Biotechnologies Co., Ltd...
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...
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CORRECTIVE ERROR CODE DESCRIPTION ACTIONS Please turn off the meter and reboot it again. If the problem E008 Scanning error. recurs, please contact the relevant technical staff. Please retest with a new test strip. If the problem recurs, The sample may not suitable E009 please contact your local dealer for qLabs testing.
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CORRECTIVE ERROR CODE DESCRIPTION ACTIONS Please retest with a new test strip. If the problem recurs, E016 FIB calculation error. please contact your local dealer and use the laboratory method to perform the test. Do not remove the test strip E018 The strip is placed improperly.
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...
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14 Operating Condition and Product Specifi cations 14.1 Operating Condition Temperature 10ºC ~ 35ºC / 50ºF ~ 95ºF Humidity 10% ~ 90% (No condensation) Maximum altitude 4300 m (14,000 feet) 14.2 Product Specifi cations Processor 32-bit ARM Cortex-M4 Display 320mm×480mm LCD Touch screen Capacitive touch screen Bar code module...
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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...
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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.
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