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Avalun LabPad INR User Manual

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INR
LabPad
®
User guide
2017/01/01

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Summary of Contents for Avalun LabPad INR

  • Page 1 LabPad ® User guide 2017/01/01...
  • Page 3 English...
  • Page 4 Index 1 Introduction 1.1 Intended use 1.2 Measurement procedure 1.3 The LabPad ® 1.4 Quality Controls 2 LabPad INR overview ® 2.1 The device 2.2 Color screen 2.3 Power supply 2.4 The Tsmart INR microcuvette ® 2.5 How to insert the microcuvette 2.6 How to discard the microcuvette 3 First use and general instructions for use 3.1 First use and initialization...

  • Page 5: Table Of Contents

    5.4 Performing a test and displaying result 5.5 Discarding the microcuvette 6 Retrieving saved results 6.1 Browsing the list of results 6.2 Reviewing results 6.3 Trend statistics of the INR range 7 Sharing results via Bluetooth 7.1 Bluetooth configuration 7.2 Operating with Bluetooth 7.3 Result display with Bluetooth 8 Error messages 9 Troubleshooting...
  • Page 6 INR for your INR measurement. ® In order to use this device, you need to obtain the appropriate microcuvettes: single-use Tsmart INR from the Avalun Company. ® Caution Caution This user guide provides you with all the information you need to operate this device optimally.
  • Page 7 Before using this device, you must consult your physician in order to be sure there is no contraindications to its use. Your physician will provide a targeted therapeutic range with a low and a high value. This therapeutic range can be saved in the device (see section 4.7 Therapeutic range for INR measurements) to be...
  • Page 8 The single-use Tsmart INR microcuvette contains a lyophilized ® reagent made of thromboplastin. When the blood sample is dropped on the microcuvette plate that has been previously inserted in the device (see section 5 Performing an INR test), it is sucked in by capillarity and gets mixed with the reagent. The coagulation reaction then begins.
  • Page 9 1.3 The LabPad ® In the box, you will find: 1) The LabPad INR testing device ® 2) A battery charger including a power adapter and a micro USB-B cable 3) A carrying bag 4) A user guide 5) A quick reference guide Check that these elements are included; if not, contact your reseller.
  • Page 10 Operating conditions and precautions for safe use To ensure the proper operation of the device as well as your own safety, please follow the instructions below. • Use your LabPad INR in a location with sufficient lighting ® and with ambient temperature between 15 and 32°C (59 to 90°F).
  • Page 11 Healthcare professionals See section 5 Performing an INR test for specific recommendations. 1.4 Quality Controls The smart meter LabPad INR is a technologically advanced ® device that runs several Quality Controls automatically before performing a test. When a problem that could prevent the test from being performed occurs, an error message is displayed on the device screen.
  • Page 12 2 LabPad INR overview ® 2.1 The device The LabPad ® Manufacturer, IVD, CE, symbols for instructions Tsmart insertion area ® Tsmart eject button ® Color screen John Smith 12:24 12:24 Browse buttons Validation button Eject Tsmart smart 2016/01/01 2017/01/01 Micro USB port Product reference number, serial number, bar code...
  • Page 13 How the user interface works: The green triangular buttons are for browsing the pages upwards or downwards. The center power button is for confirming the selection. Note Pressing the center power button for more than 2 seconds is also used to switch the device on, switch it off and access the setting menu (see section 3 First use and general instructions use).
  • Page 14 Main display Contextual information area Display area 04/21 Message area Insert Tsmart for new test Insert Tsmart for new test Current date 2017/01/01 2.3 Power supply The LabPad INR can be operated on battery or ® from an electrical power supply. For the latter, connect the provided cable to the micro USB port located on the lower part of the device and the battery charger (power adapter) to a...
  • Page 15 To recharge the battery, connect the provided cable to the USB port located on the lower part of the device and the battery charger to a power supply. The electrical socket must be installed close to the device and be easily accessible in order to be able to unplug quickly the battery charger in case of emergency.
  • Page 16 The icon with the lightening symbol means the battery is charging. Note Whatever the battery charge, it is always possible to perform an INR test by plugging the device in to a power supply. Note It is advised not to store the device when the battery is low. When the battery is totally empty, saved data are not lost but the device must be configured again (see section 3.1 First use initialization).
  • Page 17 2.4 The Tsmart INR microcuvette ® The Tsmart ® Broad curved plate on which blood drop is deposited Central micro channel that contains the reagent, where the blood drop is sucked in Datamatrix that contains all the information required to perform the INR test as well as the expiry date (see section 1.4 Quality Controls ) Please refer to the microcuvette instructions for use that contain all information for an optimal use.
  • Page 18 2.6 How to discard the microcuvette The side blue button releases the Tsmart ® INR for discarding after use (see section 5.5 Discarding the microcuvette). 3 First use and general instructions for 3.1 First use and initialization Caution • When you use the LabPad INR for the first time, plug it ®...
  • Page 19 Continue the initialization process using the triangular buttons to browse up or down and the center power button to validate and go to the next step. Welcome 12:24 John Smith 12:24 Configuration 12:24 Language John Smit LabPad LabPa d LabPad vX.X English LabPad vX.X Français Italiano The LabPad INR starts ®...
  • Page 20 12:24 12:24 John Smith John Smith Configuration Configuration Set time Time format 24h format : 05 Once completed, the start screen is displayed and the device configures itself. John Smith Welcome 12:24 John Smith 12:24 12:24 Thank you for choosing the LabPad Initialization in progress LabPad LabPad vX.X...
  • Page 21 Caution Verify that the date & time are correct. If incorrect, you will have to adjust them from the “Settings” menu (see section 4 Settings). When you get this screen, the device is ready to be used. 12:24 John Smith 12:24 Your LabPad is ready! Insert Tsmart for new test...
  • Page 22 • When you press the center power button for 2 seconds • When you connect the device with the USB cable provided 3.3 Power off The device switches off automatically after 2 minutes without use; to change this duration, follow the instructions in section 4.5 Power off.
  • Page 23 3.4 Full reset Caution A full reset means a definitive loss of all results saved in the memory as well as a cancellation of personal settings (the factory settings will be restored). Before resetting the device, the battery charge must be checked. If the indicator is red , plug it in to a power supply. You can reset the device by pressing both browse buttons during at least 5 seconds.
  • Page 24 Once confirmed, a second confirmations screen is displayed. 12:24 12:24 John Smith Full reset WARNING You are about to erase all memory and restore factory settings. Confirm Cancel 2017/01/01 Once confirmed with the center power button, the device starts again and steps are identical to the first use and configuration (see section 3.1 First use and initialization).
  • Page 25 You can access “Settings” by pressing the center power button for 2 seconds and selecting “Settings”. 12:24 12:24 John Smith 12:24 John Smith 12:24 Settings Power off Back Back LabPad Measurements Memory management Bluetooth USB connection Settings 2017/01/01 2017/01/01 To change language, date & time format, date, time, brightness and power off, select “LabPad”.
  • Page 26 4.1 Language Caution Changing the user interface language will make the device start again. John Smith 12:24 12:24 John Smith 12:24 Select language LabPad LabPad vX.X English Français Italiano 2017/01/01 2017/01/01 Once the new language is validated, wait for one of these two screens.
  • Page 27 4.2 Date & Time format Date format Time format 24hr or 12hr (am/pm) 12:24 John Smith 12:24 Set date format Date: Note MM/JJ/AAAA JJ/MM/AAAA AAAA/MM/JJ 2017/01/01 4.3 Date & Time Set Date and then Time. If you make a mistake, validate and then start again to set Date & Time from the beginning.
  • Page 28 4.4 Brightness 12:24 Brightness Brightness is set by default at the maximum level. You can choose to decrease it to reduce battery consumption. Minimum Medium Maximum 2017/01/01 4.5 Power off Choose the period of time before the device automatically powers off. 12:24 John Smith 12:24 Power off...
  • Page 29 12:24 12:24 John Smith Screen timeout Screen saving after: 2 min 5 min 10 min Never 2017/01/01 4.6 Measurement unit The default setting first displays an INR measurement with the INR value, but it is possible to visualize the same result in seconds (PT Prothrombin Time) or percentage (QT Quick Time %) by pressing the center power button then the browse buttons (see section 6.2 Reviewing...
  • Page 30 12:24 12:24 12:24 12:24 John Smith John Smith John Smith 12:24 12:24 2017/01/01 at 12:12 2017/01/01 at 12:12 2017/01/01 at 12:12 Seconds 2017/01/01 2017/01/01 2017/01/01 QT test result PT test result INR test result If the test result is outside the measuring range of the device (see section 13 Technical specifications), an error message is displayed...
  • Page 31 Enter the minimum value then the maximum value with the browse buttons. The default setting is 2.0 to 2.5. You can adjust the minimum value up to 3.5 and the maximum value up to 4.5. When you increase the minimum value, the maximum value increases simultaneously to maintain a gap of at least 0.5.
  • Page 32 12:24 John Smith 12:24 Memory management 12:24 John Smith Automatic Memory management Automatic 2017/01/01 When automatic management is off, a new option from the “Measurements” menu allows you to select a range of results to erase, starting from the oldest one. From “Measurements”, select “Results deletion”;...
  • Page 33 Caution All deletion of results is definitive. Note When automatic memory management is off and memory is full, the device will not allow any new measurement (see section 8 Error messages). 5 Performing an INR test 5.1 Prior recommendation You must configure the device before performing a first measurement (see section 3 First use and general instructions use).
  • Page 34 Healthcare professionals Additionally, use single-use gloves. Make sure lancets or lancing devices are adequate for healthcare professionals use. 5.3 Applying the blood drop onto the microcuvette Healthcare professionals Make sure the patient’s hand is warm and relaxed. Blood sampling should be done preferably on the ring or middle finger. Disinfect the finger and leave it to dry completely or dry it with a soft rag or lint-free cloth.
  • Page 35 Open the pouch to take out the microcuvette, and insert it in the insertion area of the LabPad (see section 2.5 How to insert ® microcuvette). Quality control of the microcuvette is automatic. If the expiry date has passed, error code 7 is displayed together with the icon (see section 8 Error Messages).
  • Page 36 When the “drop blood” icon is displayed, John Smith 12:24 12:24 you have 2 minutes to prick your finger and drop the blood on the microcuvette curved plate. Drop blood 2017/01/01 Check that your hand is warm. If necessary, gently massage your finger, preferably the ring or middle finger. Massage it towards the fingertip to facilitate the blood drop.
  • Page 37 The central micro channel is designed to suck the blood in as soon as the drop touches the center of the plate. Approach your finger gently and carefully towards the plate to apply your blood drop onto it. For proper filling it is important not to press your finger on the plate. Filling must be completed in one go. Caution Do not squeeze your finger. Apply the drop of blood in one single action. Squeezing your finger or drop your blood in more than one single action may lead to incorrect results.

  • Page 38: Performing A Test And Displaying Result

    Keep your finger slightly above the plate until the screen changes and you hear the “beep”. The screen shows the measurement is in progress. 2017/01/01 2017/01/01 If necessary, wipe the excess blood and apply the bandage. 5.4 Performing a test and displaying result The measurement is performed automatically within 2 minutes, and the result is displayed with the measurement unit set using the “Settings”...

  • Page 39: Discarding The Microcuvette

    When the test result is in the therapeutic range, the round indicator is in the green zone ; on the contrary, if it is out of the range, the indicator is in the red zone In this last case, make sure you follow the procedure determined with your physician or contact a healthcare professional.
  • Page 40 Caution Do not try to pull the Tsmart INR, as ® you may damage the microcuvette and leave part of it inside the device. Once the Tsmart INR is discarded, the screen displays the list of ® results with the newest result at the top. John Smith 12:24 12:24...

  • Page 41: Retrieving Saved Results

    6 Retrieving saved results All results are automatically saved in the device memory, which can save up to 1,000 measurements. 6.1 Browsing the list of results To find a result, use the triangular John Smith 12:24 12:24 buttons to browse the list of results. 1 of 10 01/01 04/21...

  • Page 42: Trend Statistics Of The Inr Range

    John Smith 12:24 12:24 John Smith 12:24 12:24 12:24 12:24 John Smith 2017/01/01 at 12:12 2017/01/01 at 12:12 2017/01/01 at 12:12 Seconds 2017/01/01 2017/01/01 2017/01/01 6.3 Trend statistics of the INR range When at least two INR results with a set therapeutic range have been saved in the memory within the last 60 days (see section 6 Retrieving saved...

  • Page 43: Sharing Results Via Bluetooth

    Note Statistics include only the results corresponding to the tests performed with the last therapeutic range setting. These statistics are displayed in the format of colored pie charts showing percentages of results respectively inferior to, superior to, and within the therapeutic range. Use the browse buttons if necessary to reset the period to examine.
  • Page 44 Select “Bluetooth” from the “Settings” menu (see section 4 Settings). 12:24 John Smith 12:24 Settings Back LabPad Measurements Memory management Bluetooth USB Connection 2017/01/01 3) Enable Bluetooth, and confirm with the center power button. 12:24 12:24 John Smith Bluetooth Bluetooth Off On 2017/01/01 Note Switching the LabPad INR on or off does not affect the last ®...
  • Page 45 The following screen offers the possibility to connect a new device or get back to the “Settings” menu. Select the desired option with the center power button. John Smith 12:24 12:24 Bluetooth Connect to: New device Known device Back 2017/01/01 The connected Bluetooth icon consequently appears on the upper left part of the LabPad INR screen.
  • Page 46 12:24 12:24 John Smith Bluetooth Waiting for connection XXXXXX Back 2017/01/01 When the connection is active, a confirmation message is displayed and the connected Bluetooth icon appears on the upper left part of the screen. 12:24 Select “Back” twice to exit the “Settings” menu, and to be able to perform a test. John Smith 12:24 12:24...

  • Page 47: Operating With Bluetooth

    7.2 Operating with Bluetooth When a device that has been connected to your LabPad ® beforehand is close by, the Bluetooth connection is activated automatically and the Bluetooth icon appears on the upper-left part of the screen. In this event, any results awaiting transmission are immediately transferred by the LabPad INR to the other ®...

  • Page 48: Error Messages

    To check transmission date & time, select a result. The screen then displays the following: 12:24 12:24 John Smith Test date & time 2017/01/01 at 12:12 INR value Date & time of Bluetooth transmission 2017/01/01 at 12:30 2017/01/01 8 Error messages When an error occurs, this icon appears followed by “Error XX”.

  • Page 54: Troubleshooting

    9 Troubleshooting Caution Never attempt to open the device. In case of doubt, contact your reseller. Caution If you notice a damage to your device (cracked screen glass, side button broken… etc.), contact your reseller. When this message is displayed “Error XX”, XX being the error reference number, see section 8 Error...
  • Page 55 Problem found Possible solution The device is not Plug the battery charger in and check working the battery icon: if it is red, leave it to charge for at least 4 hours. Battery cannot be Contact your reseller. Do not open the charged device;...

  • Page 56: Storage And Transportation

    10 Storage and transportation Store the LabPad INR in a dry place; refer to section 13 ® Technical specifications for further details on temperatures acceptable for the device. Make sure no liquid is projected on the device, in order to ensure that proper functioning is maintained.

  • Page 57: Warranty

    12 Warranty The LabPad INR is under warranty by your reseller. In the event ® of defect (see section 9 Troubleshooting) during the warranty period, the device can be repaired or exchanged. Please contact your reseller. 13 Technical specifications Range INR 0.8-8 PT 7.2-72 seconds QT 10-110% Operating conditions Place the device on a stable, flat and vibration-free surface.

  • Page 58: List Of Icons

    Battery Lithium-ion Polymer 3.7V 2100mAh Complies with IEC 62133 standard Battery charger 100-240V, 50-60Hz, input 0.2A output 1.0A, 5Vdc When charging, the range of temperature accepted is 5 to 40°C/41 to 104°F. Can withstand main supply voltage fluctuations up to ±10% of the nominal voltage. Can withstand temporary overvoltage occurring on the main supply and transient voltages up to the levels of overvoltage category II.

  • Page 59: List Of Symbols

    Heating or measuring is in progress An error occurred Battery fully charged Battery ¾ full Battery half-full Battery ¼ full Battery empty Battery is charging The device is connected to another device via Bluetooth 15 List of symbols CE marked product...
  • Page 60 Manufacturer In-Vitro Diagnostics device (IVD) Read the user guide Discard in a bin dedicated to electronic waste Serial number Global Trade Item Number Product reference Temperature limits between which the device can be safely exposed Refer to the documents inserted in the box...
  • Page 61 Symbols of the battery charger: DC voltage AC voltage The protection of the battery charger is ensured by means of double insulation. Symbol of the laser inside the device: Class I laser device...
  • Page 62 AVALUN SAS 7, Parvis Louis Néel 38000 Grenoble, France LabPad INR_IFU EN V6_1117...

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