User Manual
Contents
1. P f 7 ra z Incorrect Correct 8 10 The meter will automatically start sample evaluation and display and a time counter Within a minute the test result will be displayed on the d meter The SI unit of the test result is g dL Upto 1000 most recent test result gets automatically be stored in the meter along with their date and time stamps Remove the used test strip from the meter and dispose it as per local regulations amp blood sample disposal guidelines Test Results Warning Dehydration and low hemoglobin results You may get falsely elevated hemoglobin results if you are severely dehydrated If you think you are severely dehydrated contact your healthcare professional immediately e If you get unexpected results please check your system with control strip e If you experience symptoms that are not consistent with your hemoglobin results even after following right usage instructions in this booklet please call your healthcare professional for assistance We do not advice making significant changes to medical treatment program only based on the hemoglobin reading measured on TrueHb hemometer Viewing Results in Memory The meter stores most recent 1000 readings with their respective values of the test memory number of the test time amp date of the test Following first in first out logic oldest result automatically drops out from the memory when memory is full and a ne2. If any time within one year of purchase meter does not work for any reason you have all rights to get it replaced for a fresh meter through your authorized distributor for free The warranty is deemed to be terminated in case genuine TrueHb hemometer strips are not used with the TrueHb hemometer or when the True Hb meter or TrueHb test strips are deformed damaged or altered in any way Instruments subjected to misuse abuse neglect unauthorized repair or modification are excluded from this warranty Please complete the warranty registration card and get it stamped amp signed by your distributor at the time of purchase The TrueHb meter has a one year warranty from the original date of purchase Please write your date of purchase here DISTRIBUTOR S STAMP Protected by one or more of the patents filed by the company and its officials Developed amp Manufactured by Wrig Nanosystems Pvt Ltd TBIU Synergy Building IIT Delhi Hauz Khas N Delhi 16 Printed in India
3. Before using this product please read this manual carefully TrueHb Hemometer System This TrueHb Hemometer System Kit includes a TrueHb Meter b TrueHb control strip c Lancing Device d TrueHb User manual e Feather Touch User Manual f Warranty card If any item s is are found to be missing in kit or any visible damage in any item in the box is found please contact us at info truehb com Intended use The TrueHb Hemometer System is intended to be used for the quantitative measurement of hemoglobin in fresh capillary whole blood samples taken from the forearm upper arm hand thigh calf or fingers The TrueHb Hemoglobin Monitoring System is intended for use outside the body in vitro diagnostic use by healthcare professionals and individuals It should not be used for diagnosis of diseases or for on newborns Test principle The TrueHb Hemometer System is based on the principle of reflectance photometry A drop of blood is applied to the strip It disperses within the hydrophilic mesh The hemoglobin is extracted out from the RBC and with the help of reagents present in the strip is converted into a complex The optical reflectance is measured which is inversely proportional to the concentration of hemoglobin in the blood sample This corresponds to the total hemoglobin present in blood Important For accurate results e Read instructions carefully before use e The TrueHb Hemomet
4. age to the meter Do not let any liquids dirt dust blood or control solution spill inside the meter as it may damange the electronics of the meter Remove the batteries if device is not in use for a long period of time Store your meter strips control solution and other items in your carrying case after each use in a cool dry place below 30 C but do not refrigerate Do not store the device close to strong magnetic field wireless system or mobile telephones as this may interfere with the proper operation of the meter Clean your hands properly before performing the test Do not touch the strip where blood sample is to be applied Use the strips provided with the meter for accurate results Please check the expiration date of the strips provided on the test strip container before using them for testing the hemoglobin Store test strips only in their Original vial Do not get the water and other liquids inside the meter Keep the strip channel clean Keep the meter dry and avoid exposing it to extreme temperatures or humidity Warning Do not use your test strips if your vial is damaged or left open to air This could lead to error messages or false readings The TrueHb monitoring system contains small parts that may be dangerous if swallowed Error Messages Error 1 B What it means E F E Test strip was inserted before test strip symbol appeared on display screen What to do Take out the strip an
5. d wait until you see the test strip symbol on the display before inserting a strip Error 2 w Lo along with the I battery symbol p D0 What it means i 4 The battery is exhausted What to do Kindly charge the battery Error 3 Lo along with the temperature symbol What it means Temp is lower than the normal operating temperature What to do Kindly perform the test at a temperature between 5 45 C Error 4 g Hi along with the D 0 a thermometer Q 0 symbol What it means Temp is higher than the normal operating Temperature What to do Kindly perform the test at temperature between 5 45 C Error 5 Hi along with light E Y indicator X What it means Ambient Light intensity is higher or the meter is facing directly a light source What to do Move meter away from highly lit areas to a normal lit area and continue testing SPECIFICATIONS Photometry Measurement g dL units Memory 1000 blood sample test with date and time Operating 5 to 90 non Relative Humidity condensing Operating 10 to 45 C temperature Power Source One 3 4 volt Lithium ion rechargeable 2032 package battery Sample Whole blood capillary from fingertips Storage 4 to 40 C Conditions of Strips TROUBLESHOOTING I Meter does not turn ON P Ronen le What to Do Cause The battery is Charge the battery dead and reset the date and time if necessary The battery is Check that the insta
6. e symbol Appears if your meter is out of operating temperature range Meter use and precaution E Do not allow water or other liquids to enter the meter E Avoid exposing the meter to extreme temperature and humidity Keep the strip channel clean E Keep the meter out of reach of children Setting up the meter Turning ON amp OFF the meter Long press the D button for more than one second to turn ON the meter If the meter does not turn on try charging the device Long press the same button for more than 1 second to turn OFF the meter at any point in time Setting up Date and Time Time amp Date should be set at the date of purchase of the meter or when the battery is replaced In case the meter is kept idle for over a months time the date amp time should be checked and if it is found to be mismatching with the actual date and time the same should be set Please follow given instructions to set up the date amp time of the meter 1 Turn ON the meter and long press the A button for more than 1 second till symbols DD MM start flashing 2 Use lt and P buttons to move to the correct digit and A and V buttons to set the correct value Press to save the date 3 Once the date has been set the time character s will start flashing Set the time using the arrow keys in the manner similar to that of setting date 4 Save the time by pressing the button and restart the meter by long
7. er must only be used with genuine TrueHb Hemometer Test strips and TrueHb control strips e Test only venous or capillary whole blood Specimens EDTA or heparin anticoagulants can be used for stored blood samples Introduction Hemoglobin is a protein present in the red blood cells RBCs It is primarily associated with the transport of oxygen from lungs to different parts of the body Since total hemoglobin level in blood guides many clinical diagnosis and therapeutic interventions total hemoglobin is one of the most frequently ordered laboratory tests Serial assessments are often made to track disease progression blood loss and efficacy of the therapies involving restoration of hemoglobin levels to normal Total hemoglobin level screening involve blood donors in blood banks blood transfusion patients dialysis patients biliary patients etc N a Upper arm J f Forearm 3 _ Finger tips y n F Calf TrueHb meter can be used for measuring Hb from samples taken from the forearm upper arm hand thigh calf or fingers Normal Hemoglobin Levels The normal hemoglobin range anything below or above range is low or high hemoglobin respectively is indicated as follows Adult Males 13 5 18 g dL Adult Females 12 16 g dL Warnings e We recommend to take blood samples from the tip of your fingers e Severe dehydration and excessive water loss may cause falsely elevated results e TrueHb m
8. eter contains small parts that may be dangerous if swallowed e Keep the TrueHb device and TrueHb strips out of children s reach About TrueHb Meter Charging Port Display Screen Up Arrow button Left Arrow Off On Select button Button Right Arrow Down Arroy Button Button Test Strip Holder Test area Display Screen Displays your test results date time etc Right Left Up and Down Buttons To move among displayed items On Off Select button To turn the meter on and off and to select displayed items Test Strip Slot For inserting the test strip Mini USB Charging Port For charging the battery Display Indications DD MM Shows Date and month Batch code Indicates the code number of test strips Battery Symbol Indicates the battery level Strip Symbol Indicates when to insert test strip Clean Lens Excess Light Symbol Warning Battery Symbol Date Memory Mode Symbol Memory counter Blood Drop Symbol Batch Code Symbol Temperature Warning Test Result Area Strip Symbol Time Measurement Waiting Unit Symbol Blood Drop Symbol This symbol appears when the meter is ready for you to apply blood drop Test Result Area Shows the hemoglobin level Measurement Units Indicates the units for the test result g dL Memory Indicates a test result is being recalled from memory Light indicator when light intensity is higher than normal Temperatur
9. lled battery is installed incorrectly correctly There is no Install the battery battery in the meter The display is damaged Defective meter Meter doesn t Take out the battery charge in case and reinsert it after 5 the meter is minutes Recharge not in use fora the meter long period immediately Always remove out the battery in case storing the meter for a long period Il Wide variance of results within short period of time Probable katto Da Cause Meter Optical Detector is dirty or has been improperly cleaned Incorrect blood sampling done Insufficient amount of Blood Test strips damaged or improperly maintained Meter body damaged or hardware problem Properly clean meter with damp cloth Take blood sample without milking the body part while taking a capillary sample Homogenize the stored blood before sample applying it on strip Make sure test region is completely reddened with enough blood sample at least 10ul Change test strips Contact distributor Symbols SEE mo EF O 6 L a p c m i 4 x EJ Consult instruction for use Manufacturer For in vitro diagnostic use only Storage Temperature Range Catalogue Number Do not reuse Expiry Date Keep away from sunlight and heat Do not discard along with household waste Sterilized by irradiation Test per kit Serial number Code number WARRANTY CARD
10. pressing for over 1 second Performing the Test Turn ON the meter The system undergoes an autocheck and auto calibration after which the battery level date time and strip s batch code are displayed within 2 seconds If the displayed batch code is found to be different from the code mentioned on the strip bottle Use lt and P buttons to move to the correct digit and A and W buttons to set the correct value Accept the batch code by pressing the button The meter would flash strip symbol on the display Insert a fresh test strip into a meter with the arrows on the strip facing up and pointing towards the display Ensure the correct positioning of the strip with the guiding V notch and the positioning hole in the strip properly placed and locked 5 Do not allow fingers or other foreign objects to come in contact with the white test area of the test strip 6 Immediately after inserting the fresh test strip the display would flash the symbol Prick a body surface using a lancing device or a syringe and drop a hanging drop of blood from the freshly lanced finger on the white test area of the strip Make sure the body part used for extracting blood sample is clean and disinfected For lancing instructions please refer to the lancing device user maual 7 Ensure that there is sufficient blood a minimum of 10ul to completely cover the white colored test area a 7 7
11. w result is recorded by the meter To reach in the memory mode long press left lt q button for over a second after turning ON the meter View recorded results of past dates follow given steps To jump across readings stored across different dates use lt and buttons to scroll the date Use A and V buttons to view the results of a particular date The readings on a particular day will be displayed First reading of the date would be displayed first followed by the later readings Turn OFF the meter to exit the memory mode menu Caring For Your Meter The meter should be cleaned after each use to remove any excess blood Remove any residual blood or other matter on the outside of the meter by using gauze or cloth dampened with an appropriate disinfectant such as a mild detergent mild soap and water Clean the optical lens regularly using a water moist cotton cloth everyday or in case where dust or dirt has fallen on the optical lens Make sure you do not scratch the optical lens surface as damaging the lens may lead to inconsistent results Do not use alcohols to clean the meter Alcohols damage the meter and the optical lens Do not use strong abrasive or corrosive cleaning solutions as they can damage the meter and the optical lens Never dip or immerse the device in disinfectant solution Do not clean the unit with substances such as gasoline paint thinner or other organic solvents to avoid any dam
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