Align Gluco-Monitoring System (BG1) OWNER`S MANUAL
Contents
1. control of your diabetes Due to the meter s compact size and simple operation you can easily self monitor your blood glucose levels anywhere anytime If you have questions regarding this product please visit www ihealthlabs com contact your place of purchase or call iHealth Labs Customer Service at 1 855 816 7705 INTENDED USE The iHealth Align Gluco Monitoring system BG1 is intended to be used for Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip palm forearm upper arm calf or thigh Single person measurement it should not be shared e Self testing outside the body vitro diagnostic use as an aid to monitor the effectiveness of diabetes control The iHealth system should not be used for the diagnosis of or screening for diabetes or for neonatal use Alternative Site Testing AST should be performed only during steady state times when glucose levels are not changing rapidly e Health Blood Glucose Test Strips AGS1000I are intended for use with the Health Align Gluco Monitoring System to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips palm forearm upper arm calf or thigh e The Health control solutions are intended for use with the Health Align Blood Glucose Monitoring System to check that the glucose meter and test strips are working properly These solutions contain a known range of glucose as indicate2. glucose meter with blood samples collected in a test tube Use fresh capillary blood only TEST STRIP VIAL LABEL 2 5 Test Strips e a Bandelettes Model Mod le AGS 10001 Blood Glucose Test Strips Bandelettes pour lecteur de glyc mie To measure blood glucose levels from fresh capillary whole blood For use with Smart Gluco Monitoring System and Wireless Smart Gluco Monitoring System only Expires 90 days after first opening For in vitro diagnostic use only Consult instructions for use Do not reuse Single patient use for self testing only Pour mesurer le taux de glyc mie d un chantillon de sang total frais capillaire Pour utilisation avec le Syst me intelligent de surveillance de la glyc mie et Syst me intelligent de surveillance de la glyc mie sans fil uniquement Expire 90 jours apr s ouverture Pour diagnostic in vitro uniquement Consultez les instructions d utilisation Usage Note Scan QR code before first use Remarque Lire le code QR avant la premi re utilisation de ce flacon Control Solution Range Plage de la Solution de contr le LEVEL NIVEAU mg dL mmol L Lot No Lot N Use by Utiliser avant le Date Opened Date d ouverture Manufactured for Fabriqu pour iHealth Lab Inc USA iHealth Lab Inc wn ems ee com Mountain View CA 9 unique Pour un usage domicile pour des personnes diab tiques Store at 39 F 86 F 4 C 30 C Do not refrigerate Keep away from direct sunlight Cons
3. or patients who are in shock Test results that are lower than actual values may occur in individuals who are in a hyperglyce mic hyperosmolar state with or without ketosis Please consult your healthcare professional before use If your blood glucose results are lower or higher than usual and you do not have symptoms of illness first repeat the test If you have symptoms or continue to get results that are higher or lower than usual follow the treatment advice of your healthcare professional 4 If you are experiencing symptoms that are inconsistent with your blood glucose test and you have followed all of the instructions provided in this Owner s Manual contact your healthcare professional immediately Use only fresh whole blood samples to test your blood glucose Do not use test strips that are expired or appear to be damaged as they may return inaccurate results Always use care when handling the iHealth Align Glucose Meter Dropping or throwing the meter may cause damage Don t expose the Health Align Glucose Meter test strips or control solution to extreme conditions such as high humidity heat freezing cold or dust The lancing device is for self use only Do not share or re use lancets Please refer to the Lancing Device Manual for the detailed procedure GET STARTED e Download the App Prior to first use download the free iHealth Gluco Smart App to your mobile device from the Apple App Store or Googl
4. d on the bottles The iHealth Gluco Smart App is the iOS application for the iHealth Gluco Monitoring System and is used for data extraction and analysis IMPORTANT SAFETY INSTRUCTIONS Please read the following information carefully before using the iHealth system Always keep 1 these instructions in a safe place for reference Misuse of the Health system can cause electrocution burns fire and other hazards The glucose meter and lancing device are for single patient use Do not use either item on multiple patients Do not share the glucose meter or lancing device with anyone including other family members Do not place the Health system in or near liquid e Use the Health system only for the purpose described in the Owner s Manual Use only iHealth branded accessories Do not use the Health system if it has sustained any damage is not working properly e Keep the Health system away from heat at all times Do not let the Health system come into contact with surfaces that are hot to the touch Do not block test port or place the glucose meter on soft surfaces that may block the test port Keep test port free from lint hair debris etc Do not place anything on top of the glucose meter e Do not place foreign objects into any opening in the glucose meter Do not use the glucose meter in a manner not specified by the manufacturer When not in use please disconnect the glucose meter f
5. e Play Store Follow the on screen instructions to create your iHealth account Access Health Cloud Account Your iHealth account also gives you access to the free and secure iHealth cloud service Go to www ihealthlabs com and click Sign In for access once your account has been created Scan to Code Test Strips Please carefully read and follow the instructions below to avoid getting inaccurate test results and or test strip tracking error Connect your mobile device to the Internet and open the Gluco Smart App When prompted scan the QR code on the top of the iHealth test strip vial to calibrate the test strips with the meter You must scan the QR code each time a new vial is opened Test blood glucose level Step 1 Launch the App Step 2 Connect the meter Plug your meter into the headphone jack of your mobile device The iHealth logo on the meter should be facing the same direction as the screen of your mobile device 5 Note Do not twist your meter during the measurement process You might need to remove the case on your mobile device before connecting the meter Step 3 Insert the test strip into the meter s strip port Make sure the red arrow marker on the test strip is facing the same direction as the iHealth logo on the meter Step 4 Prepare the lancing device O Q Snap off the lancing device cap O Insert a new lancet firmly into the lancing device holder cup O Twist the lance
6. erver entre 4 C 30 C 39 F 86 F Ne pas r frig rer Ne pas exposer a la lumi re directe du soleil 1 855 816 770 8 AM 5 00 PM PST B nas to Friday iu Europe iHealthLabs www ihealthlabs eu 3 Rue Tronchet 75008 Paris France 33 0 1 44 94 04 81 9 00 AM 5 30 PM Monday to Friday V2 0 7 iHealth Align GLUCO MONITORING SYSTEM SPECIFICATIONS ONOO BW n Model BG1 Machine size 2 03 x 1 17 x 0 37 52mm x 30mm x 9 5mm Measuring method Amperometric technology using glucose oxidase Result range 20 mg dL 600 mg dL 1 1 mmol L 33 3 mmol L Power source DC3 0V CR1620 Storage condition Test Strips 39 2 F 86 Storage condition The meter 4 F 131 F 20 C 55 C Humidity 1096 8096 RH Operating conditions 50 F 95 F 10 C 35 C Blood source Fresh capillary whole blood 10 11 12 F 4 C 30 C Humidity 10 8096 RH Blood Sample Size Min 0 7 microliter Product life span Five years The table of substances below shows the highest concentration without significant interference x 10 error 14 Compounds Limitation Ascorbic acid 2mg dL Uric acid gt 10mg dL Acetaminophen gt 5mg dL Bilirubin gt 15mg dL Dopamine gt 0 03mg dL L dopa gt 0 45mg dL Triglycerides gt 2000mg dL Hemoglobin gt 250mg dL LIMITATIONS OF USE The iHealth Align Gluco Monitoring System is not intended for
7. ervice Manufactured for iHealth Lab Inc USA iHealth Lab Inc www ihealthlabs com Mountain View CA 94043 USA 1 855 816 7705 8 30 AM 5 30 PM PST Monday to Friday except holidays Email support ihealthlabs com Europe iHealthLabs Europe SARL www ihealthlabs eu 3 Rue Tronchet 75008 Paris France 33 0 1 44 94 04 81 9 00 AM 5 30 PM Monday to Friday except holidays Email support ihealthlabs eu ANDON HEALTH CO LTD padl No 3 Jin Ping Street Ya An Road Nankai District Tianjin 300190 China Tel 86 22 60526161 17 EXPLANATION OF SYMBOLS In vitro diagnostic medical device S N Serial number Caution consult accompanying documents Consult instructions for use Manufacturer Electrical products waste should not be disposed of with household waste Please recycle where facilities exist Check with your local authority or retailer for recycling advice DES REP Authorized representative in the European Community m Oo C THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES 4 4 dt Keep away from rain LOT Lot Number Use by date Sterilized Using Irradiation Do not Reuse C O 1 O 7 Complies with IVD98 79 EC requirements KA IMPORTANT INFORMATION REQUIRED BY THE FCC Changes or modifications not expressly approved by iHealth Lab Inc would void the user s authority to operate the product NOTE This product has been tested and found to comply with the limits for a Class B digital dev
8. he testing takes place When traveling across time zones living on or near a time zone boundary you need to be aware that the logged glucose measurement times may not be synchronized to your normal day to day regime f you take insulin and will be traveling across time zones talk to your health care professional before your trip SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists or error messages other than the ones below appear please call iHealth Labs Customer Service at 1 855 816 7705 Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances Problems The meter does not respond after the test strip has been inserted into the glucose meter Possible Causes 1 The meter is not correctly connected to a mobile device Solution s 1 Remove the meter from the mobile device and reconnect 2 Too much time has passed between inserting the test strip and performing the test 2 Remove and reinsert the test strip into the glucose meter 3 Test strip has not been fully inserted into the glucose meter 3 Reinsert the test strip into the glucose meter Test results are inconsistent or control solution test results are not within the specified range 1 Not enough blood sample in the test strip 1 Retest with a new test strip and make sure that enough sample has been applied 2 Test strip or contr
9. iHealth Align Gluco Monitoring System BG1 OWNER S MANUAL mem mem For in vitro diagnostic use only Read instructions before use for self testing Table of Contents INTRODUCTION I Im e eee me 1 INTENDED USE HIM 1 IMPORTANT SAFETY INSTRUCTIONS m 1 CONTENTS OF THE Health Align GLUCO MONITORING SYSTEM 2 TEST PRINCIPLE 4 IMPORTANT TEST INFORMATION 4 5 USING PHONE SANITARY COVER error 8 REFERENCE VALUE OF THE Health Align GLUCO MONITORING SYSTEM 8 THE IHEALTH SYSTEM CARE AND MAINTENANCE 9 PERFORMING A BLOOD GLUCOSE TEST WITH ALTERANTE SITE 11 IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS 12 COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS 13 TEST STRIP VIAL LABEL e 14 Health Align GLUCO MONITORING SYSTEM SPECIFICATIONS 14 LIMITATIONS OF USE I meme 15 SYSTEM TROUBLESHOOTING e 16 WARRANTY INFORMATION 17 EXPLANATION OF SYMBOLS M M MH 18 IMPORTANT INFORMATION REQUIRED BY THE FCC 19 INTRODUCTION Thank you for purchasing the iHealth Align Gluco Monitoring System BG1 This manual provides important information to help you use the system properly Before using this product please read the Owner s Manual thoroughly Regular monitoring of your blood glucose levels can help you and your doctor gain better
10. ice pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This product generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this product does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme la norme NMB 001 du Canada V1 0 19
11. lucose results fluctuate often Caution Alternate Site Testing should not be used to calibrate continuous glucose monitoring systems CGMs Results from Alternate Site Testing should not be used in insulin dose calculations IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS The control solution contains a known amount of glucose that reacts with test strips and is used to check that your meter and test strips are working together properly The result of the control solution test should be within the range printed on the test strip vial label Materials needed to perform a control solution test Health Align Gluco Monitoring System BG1 e Health Blood Glucose Test Strip AGS10001 e Health Control Solution Level I Level Il or Level III Perform a control solution test when First receiving or purchasing the meter Checking the meter and test strips which should be done at least once a week Using a new vial of test strips You suspect the meter and or test strips are not working properly Your blood glucose test results are not consistent with your expectations or you think the results are not accurate e Practicing the testing process After the test strips are exposed to extreme conditions The meter has been dropped or damaged Out of Range Results Results falling outside the specified range may be caused by Error in performing the test Expired or contaminated control solution Expi
12. ng from your package or the package appears to have been opened prior to your use please call iHealth Labs Customer Service at 1 855 816 7705 2 The lancing device can be used multiple times however the lancet should be changed after each use 3 The number of sanitary covers for the mobile device is equal to the number of test strips 4 Only iHealth Level Il control solution is included in the package If you need level I and level Ill control solution please call Health Labs Customer Service at 1 855 816 7705 for assistance 5 Content may vary according to geographic markets Please check your package Mobile Device Compatibility The iHealth system is compatible with select iOS and Android devices For a complete list of compatible devices visit our support page on www ihealthlabs com TEST PRINCIPLE Testing with the iHealth system is based on the measurement of electrical currents generated by the reaction of glucose with the reagent of the test strip The iHealth system measures the current and converts it to the corresponding blood glucose level The strength of the current produced by the reaction depends on the amount of glucose in the blood sample IMPORTANT TEST INFORMATION e Severe dehydration or excessive water loss may cause inaccurate results If you believe you are suffering from severe dehydration consult your healthcare professional immediately Inaccurate results may occur in severely hypotensive individuals
13. ol solution has expired 3 Test strip has been damaged due to heat or humidity 4 iHealth System is not performing due to the environment being above or below room temperature 16 2 Retest with a new test strip or new control solution 3 Perform a control solution test using a new test strip If results are still out of range replace with new vial of test strips 4 Bring the iHealth System to room temperature environment and wait approximately 30 minutes before performing a new test After blood sample has been Test strip is not inserted properly Use a new test strip and redo the test applied to the test strip testing doesn t start WARRANTY INFORMATION iHealth Lab Inc IHealth warrants the iHealth meter the Product and only the Product against defects in materials and workmanship under normal use for a period of three years from the date of purchase by the original purchaser Warranty Period Under this Limited Warranty if a defect arises and a valid claim is received by iHealth within the Warranty Period regarding the Product at its option and to the extent permitted by law iHealth will either 1 repair the Product using new or refurbished replacement parts or 2 exchange the Product with a new or refurbished Product In the event of a defect to the extent permitted by law these are the sole and exclusive remedies For more information please visit www ihealthlabs com or contact customer s
14. oration of the meter casing or lancing device for example it is difficult to read the labeling information 3 Corrosion crazing fine cracks embrittlement and or cracking of the meter casing or lancing device PERFORMING A BLOOD GLUCOSE TEST WITH ALTERNATE SITE You have the option of taking a blood sample from other sites on your body besides the fingertip The iHealth system allows you to test on your palm forearm upper arm calf or thigh with equivalent results to fingertip testing when used appropriately Remember to replace the lancing device cap with the clear cap and follow the above Test blood glucose level instructions to perform an Alternate Site Test Upper Arm Forearm Calf Food medication illness stress and exercise can affect blood glucose levels Capillary blood from the fingertips reflects these changes faster than capillary blood from other sites AST should be used only during steady state times when blood glucose levels are not changing rapialy You may perform Alternate Site Testing in the following instances In a pre meal or fasting state two hours or more after the last meal Two hours or more after taking insulin Two hours or more after exercising You should NOT perform AST if You think your blood glucose is low You are unaware that you might have hypoglycemia You are testing for hyperglycemia Your AST results do not match the way you feel Your routine g
15. process Discard the used test strip and lancet properly Note Refer to the Cleaning and Disinfecting section of the Owner s Manual for cleaning and disinfecting procedures USING PHONE SANITARY COVER We strongly advise that you put your mobile device into the sanitary cover before testing The sanitary cover is for single testing use only Please contact iHealth customer service for purchasing additional sanitary covers N 22 22 Cr m N SN REFERENCE VALUE OF THE iHealth Align GLUCO MONITORING SYSTEM Time of day People without diabetes Fasting and before meals 100 mg dL 2 hours after meals 140 mg dL 1 American Diabetes Association Diagnosis and Classification of Diabetes Mellitus Position Statement Diabetes Care 34 Supp 1 S66 2011 2 Tietz Fundamentals of Clinical Chemistry 6th Edition Edited by Burtis CA and Ashwood ED W B Saunders Co Philadelphia PA 2008 p 849 Please consult a healthcare professional for interpretation of your blood glucose measurements and to determine a target range that is best for you THE IHEALTH SYSTEM CARE AND MAINTENANCE Replacing the battery Your meter comes with one 3V CR1620 lithium battery installed The battery lasts up to six months depending on the usage Follow the instructions below to replace the battery 1 Turn the meter over with the iHealth logo facing down 2 Lift off the back cover by pulling fi
16. red or contaminated test strip e Meter malfunction If you continue to get control solution test results that fall outside of the range printed on the vial the meter may not be working properly Discontinue use and call iHealth Labs Customer Service at 1 855 816 7705 for assistance To purchase additional control solution call iHealth Labs Customer Service NOTE Do not use expired control solution The control solution range printed on the test strip vial is for control solution use only It is not a recommended range for your blood glucose level COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS The iHealth system provides you with whole blood equivalent results The result you obtain from your glucose meter may differ somewhat from your laboratory results due to normal variation The iHealth system results can be affected by factors and conditions that do not affect laboratory results in the same way To make an accurate comparison between the iHealth system and laboratory results follow the guidelines below Before the Lab Test Perform a control solution test to make sure that the meter is working properly If possible fast at least eight hours before conducting a comparison test Take the iHealth system with you to the lab While at the Lab Make sure that samples for both tests are taken and tested within 15 minutes of each other Wash your hands before obtaining a blood sample Never use your
17. rmly from the notch next to the test strip port 3 Remove the battery by pressing the small white eject button next to the battery tray 4 Insert the new battery with the side facing up and snap it into place 5 Press the back panel back in place by inserting the front clip into place and snapping the back of the cover down When the Battery is low indicator appears within the app replace the battery to ensure successful and accurate measurements Disposal Electrical products should not be disposed of with household waste Please mmm where facilities exist Check with your local authority or retailer for recycling advice Cleaning And Disinfecting the Meter and Lancing Device The cleaning and disinfection is absolutely necessary for the test procedure because cleaning can ensure the meter works well for example display will be clear to see after cleaning and disinfection will reduce the chance of spreading infection to others The meter and lancing device should be cleaned and disinfected following each use We suggest that you use CaviWipes Metrex Research Corporation EPA Reg No 46781 8 EPA Est No 9 56952 WI 001 CaviWipes with isopropanol and diisobutyl phenoxy ethoxyethyl dimethyl benzyl ammonium chloride as the active ingredients have been shown to be safe for use with the meter and lancing device You can purchase this product from the suppliers listed below 1 Visit the
18. rom the mobile device All parts of the iHealth system are considered biohazards and can potentially transmit infectious diseases even after you have performed cleaning and disinfection Please refer to the resources identified below for detailed information FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html CONTENTS OF THE iHealth Align GLUCO MONITORING SYSTEM Package contents may vary according to geographic markets Please refer to the package contents listed on the package you purchased Connector Absorbent hole Confirmation window Test strip handle Contact bars Test Strip Port The Meter The Test Strip AGS10001 EN Cocking Handle cc Lancet Removal Handle Release Button Depth Indicator Window White Cap for finger testing 2 iHealth Lancing Device e Health Control Solution Level II Lancet Cap e Lancet Clear Cap for Alternate Site Testing Note 1 If any items printed on the package are missi
19. t cover off Replace the lancing device cap Set the lancing level to your desired pressure level Q Cock the handle until it clicks Step 5 Obtain a blood sample Press the lancing device against the site to be lanced and then press the release button to puncture the site Gently squeeze the site until a drop of blood forms XQ Step 6 Apply the blood sample to the test strip Quickly apply the blood sample to the absorbent hole on the tip of the test strip Make sure the confirmation window of the test strip is completely filled with the blood sample and remove your finger Step 7 Read the test results After approximately 5 seconds your blood glucose result will appear on your mobile device screen The meter needs to remain connected to your mobile device during testing and syncing Note The results obtained from the glucose meter are plasma calibrated This helps you and your physician or other qualified healthcare providers to compare your meter results with laboratory tests Refer to the instructions given by your physician or other qualified healthcare providing Do not deviate from these instructions on the basis of the result without first consulting your physician Step 8 Discard the used test strip and lancet Remove the used test strip from the meter using a tissue Remove the lancet from the lancing device Tip Prior to disposal stick the lancet into the cover that was snapped off earlier in the
20. use on neonates The iHealth Align Gluco Monitoring System is not intended for use on artery blood serum and plasma The Health Align Gluco Monitoring System should only be used with Health test strips AGS1000 The Health Align Gluco Monitoring System can be used up to an altitude of 10 744 feet 3 276 meters The following substances at levels greater than normal or therapeutic levels may cause significant interference affect the result by greater than 10 resulting in an inaccurate result ascorbic acid uric acid acetaminophen dopamine L dopa These substances do not affect test results in normal concentrations but may affect test results in high concentrations Do not use haemolysis samples icterus samples or high lipemia samples Patients undergoing oxygen therapy may show results lower than actual levels Not for use for patients in a hyperglycemic hyperosmolar state with or without ketosis Not for use on critically ill patients Not for patients who are dehydrated hypertensive hypotensive or in shock Very low or very high red blood cell count hematocrit can lead to incorrect test results If you do not know your hematocrit level please consult your healthcare provider We recommend periodic 15 comparison of the iHealth system to another monitoring system known to be well maintained and monitored by a healthcare provider The meter will automatically adjust for the current time zone when t
21. website www metrex com or contact Metrex at 800 841 1428 for product or technical information 2 Visit the website http www endochoice com Equipment search wipe The meter and lancing device are validated to withstand 11 000 individual tests and 11 000 cleanings over their 5 year life spans Steps for cleaning and disinfecting the meter and lancing device 1 After a test clean and wash your hands 2 Use one CaviWipe to carefully clean the meter front and back 3 Disinfect the meter with another wipe and let it air dry 4 Use the same method with the CaviWipes to clean and disinfect the lancing device 5 Take off and discard the sanitary cover for the mobile device after each test WARNING D Each disinfection step requires a pre cleaning step Wash hands thoroughly with soap and water after handling the meter lancing device or test strips 2 Only the surface of the meter can be cleaned and disinfected with the disinfecting towelette Do not insert the CaviWipe into the test port Signs of Potential Physical And Performance Deterioration If you encounter any of the following circumstances stop using the meter and contact the place of purchase for assistance or call the iHealth toll free customer service number at 1 855 816 7705 1 The device does not work for example the mobile device does not begin testing when the meter is connected with the mobile device and when a test strip is inserted into the meter 2 Discol
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