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For in vitro diagnostic use only

Read instructions before use For self-testing

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iHealth

WirelessSmartGluco‐MonitoringSystem(BG5L)

OWNER’SMANUAL

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TableofContents

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INTRODUCTIN ............................................................................................................................... 3

PACKAGE CONTENTS................................................................................................................. 3

SETUP REQUIREMENTS ............................................................................................................ 4

INTENDED USE ............................................................................................................................. 4

How the Test Works? ..................................................................................................................... 5

IMPORTANT SAFETY INSTRUCTIONS .................................................................................... 5

IMPORTANT TESTING INFORMATION ..................................................................................... 6

INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST) ............................................. 7

WhatisAlternateSiteTesting? ................................................................................................. 7

WhatistheAdvantageofAlternativeSiteTesting? ................................................................. 8

WhentoUseAlternativeSiteTesting? ..................................................................................... 8

PARTS AND DISPLAY INDICATORS ......................................................................................... 9

GlucoseMeter ........................................................................................................................... 9

BloodGlucoseTestStrip ......................................................................................................... 10

SETUPPROCEDURES ............................................................................................................ 11

TESTING WITH A BLOOD SAMPLE ........................................................................................ 12

Offline measurement mode：(not using iOS device) ............................................................. 12

ApplytheTestStrip.........................................................................................................12

ObtainingaBloodSample...............................................................................................12

ApplyYourBloodSample................................................................................................12

ReadtheTestResults......................................................................................................12

DiscardtheUsedTestStrips............................................................................................12

DiscardtheUsedLancet..................................................................................................13

Online measurement mode：(with iOS device) ..................................................................... 13

ApplytheTestStrip.........................................................................................................13

ObtainingaBloodSample...............................................................................................13

ApplyYourBloodSample................................................................................................13

ReadtheTestResults......................................................................................................14

DiscardtheUsedTestStrips............................................................................................14

DiscardtheUsedLancet..................................................................................................14

Control Solution ............................................................................................................................ 14

Summary of content (25 pages)

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For in vitro diagnostic use only Read instructions before use For self-testing iHealthTMWireless Smart Gluco‐Monitoring System (BG5L) OWNER’S MANUAL Table of Contents INTRODUCTIN ............................................................................................................................... 3 PACKAGE CONTENTS................................................................................................................. 3 SETUP REQUIREMENTS ...................................................
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Performing an Offline Control Solution Test with Meter Alone (not using iOS device) ........ 15 I Performing an Online Control Solution Test (with iOS device) ........................................... 16 IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS............................... 17 METER MEMORY ........................................................................................................................ 17 Offline measurement mode：(not using iOS device) ....................................
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INTRODUCTIN Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (BG5L). Before using this product, please read the following contents thoroughly and carefully. This manual provides important information to help you use the system properly so you get accurate readings every time. Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes.
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z Owner’s Manual z Quick Start Guide z USB Charging Cable z Control Solution* Note: * These contents may vary according to geographic markets. You must check your package. If any items printed on the package are missing from your package or the package is opened prior to use, please contact the place of purchase for assistance. The lancing device can be used several times, however, the lancet should be changed after each use.
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• Self‐testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The iHealth Wireless Smart Gluco‐Monitoring System (BG5L) should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternate Site Testing (AST) should be done only during steady – state times when glucose levels are not changing rapidly.
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z The Wireless Smart Glucose Meter and lancing device are for single patient use. Do not use on multiple patients. Do not share the Wireless Smart Glucose Meter or lancing device with anyone, including other family members. z Do not place the Wireless Smart Glucose Meter in or near liquid. z Use the Wireless Smart Glucose Meter only for the purpose described in the Owner’s Manual. z Do not use accessories that are not supplied by the manufacturer.
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z If you are experiencing symptoms that are inconsistent with your blood glucose test results, and you have followed all the instructions provided in this Owner’s Manual, contact your healthcare professional. z Inaccurate results may occur in severely hypotensive individuals or patients who are in shock. Test results that are lower than actual values may occur in individuals who are in a hyperglycemic‐hyperosmolar state, with or without ketosis. Please consult your healthcare professional before use.
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What is the Advantage of Alternative Site Testing? Pain is felt more readily on the fingertips because they are full of nerve endings (receptors). At other body sites where nerve endings are not so condensed, pain is not felt as acutely. When to Use Alternative Site Testing? 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.
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PAR RTS AND DISPLAY INDICATORS Gluccose Meter Page 9 of 25
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Bloo od Glucose Te est Strip Eaach test strip is intended fo or single use only and should be discard ded immediately after use e Test strip ps consist of th he following parts: p Page 10 0 of 25
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NOTE: Only use iHealth Blood Glucose Test Strip with the iHealth Wireless Smart Gluco-Monitoring System (BG5L). Other test strips may produce inaccurate results. SETUP PROCEDURES Prior to the first use, set the meter time by connecting the meter with your iOS device via Bluetooth. Complete the steps below to have your desired time settings saved in the meter. After connecting to your iOS device via Bluetooth and launching the App, you can view your measurement status and your test results on the screen. 1.
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TESTING WITH A BLOOD SAMPLE Offline measurement mode：(not using iOS device) Apply the Test Strip Take a test strip from its vial. You may touch the test strip anywhere on its surface with clean dry hands. Do not bend, cut or modify the test strips in any way. Use each test strip immediately after removing it from the vial. Insert the test strip into the test port of the glucose meter.
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bloood glucose meeter. Discard the used test strips directly y into the waaste containerr Disccard the Used d Lancet Discard the used d lancet directly into a container desig gned for sharrp objects. Always wash hands h thoroughly with soap s and wateer after handliing the meterr, lancing device, test stripss. Notee: Please consult a healthca are professiona al for interprettation of blood d glucose measurements.
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from m the blood saample Read the Test Results Yo our blood gluccose results will w be displayeed on the iOS device. Notee: The resultts obtained froom the glucosee meter are pla asma‐calibratted. This helps you and your physsician or otherr qualified heallthcare provid ders to comparre your meter results r with laaboratory testss.
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Material needed: z iHealth Wireless Smart Gluco-Monitoring System (BG5L) z iHealth AGS-1000I Blood Glucose Test Strip z Control Solution Perform Control Solution test when: z First receiving the meter z Checking the meter and test strips at least once a week z Using a new vial of test strips z You suspect the meter or test strips are not working properly z Your blood glucose test results are not consistent with how you feel, or if you think the results are not accurate z Practicing the testing process z The
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• Hold the meter and move the absorbent hole of the test strip to catch the drop. Once the confirmation window fills completely, the meter will start counting down. Please leave the test strip blood samples when the countdown begins Note: To avoid contaminating the entire vial of Control Solution, do not directly apply Control Solution onto a strip. Step 5: Read and Compare the Results After counting down to “1” the Control Solution test result will appear on the meter display.
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IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS When performing a Control Solution test to check your glucose level, be sure to select the Control Solution test on the app. Control Solution tests conducted in regular testing mode will save results with regular test results, which may yield inaccurate blood glucose levels.
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Online measurement mode：(with iOS device) Press and hold the Memory Button for 3 seconds to turn the meter on. Enable the Bluetooth function on your iOS device. When the “ ” symbol appears, the meter is in Bluetooth communication mode. You may perform a test even when the meter is not connected to your iOS device via Bluetooth, and the meter will save up to 500 test results. launch the App and follow the on-screen instructions. Test results will be transmitted to the App with date and time.
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Before Going to the Lab z Perform a Control Solution test to make sure that the meter is working properly. z If possible, fast for at least eight hours before conducting a comparison test. z Take your Wireless Smart Glucose Meter 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. z Wash your hands before obtaining a blood sample. z Never use your glucose meter with blood samples collected in a test tube.
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Maintenance and Storage of your Wireless SMART GLUCOSE METER z Always use care when handling the Wireless Smart Glucose Meter. Dropping or throwing the meter may cause damage. z Don't expose the Wireless Smart Glucose Meter, test strips, or Control Solution to extreme conditions such as high humidity, heat, freezing cold or dust. z Always wash your hands with soap and water, and rinse and dry them completely before handling the Wireless Smart Glucose Meter and test strips.
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do not know your hematocrit level, please consult your healthcare provider. We recommend periodic comparison of the iHealth Wireless Smart Gluco‐Monitoring System to another monitoring system known to be well maintained and monitored by a healthcare provider. SYSTEM TROUBLE SHOOTING 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.
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Problems have occurred Please use a new test that are related to test strip strip and re-test. use. Problem with the meter. Re-test with a new test strip. If the problem persists, please call iHealth Labs Customer Service at +1‐855‐816‐7705 for assistance. The environmental Please test at a higher temperature is lower than environmental 50℉ temperature. The environmental Please test at a lower temperature is higher than environmental 104℉ temperature.
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Test results are 1. inconsistent or Control Solution test results are 2. not within the specified range. 3. Meter. Not enough sample in the Test Strip. Test strip or Control Solution has expired. Test strip has been damaged due to heat or humidity so that the sample cannot be applied, or the speed of application is too slow. System is not performing due to the environment being above or below room temperature. 1. Re-test with a new Test Strip and make sure that enough sample has been applied. 2.
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Auth horised repressentative in th he European Community C FC CC ID:Z ZRYBG5 5L Bluettooth sign Keep dry d Complies with w IVD98/79 9/EC require ements alth is a trade emark of iHe ealth Lab Inc. iHea “ for iP Phone” mean n that an elecctronic acces ssory “Made for iPod” “Made for iPad”and “Made ned to connect specifica ally to iPod, iPad,iPhone e, respectivelly, and has been b has been design d to meet Apple e performanc ce standards.
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conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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 device, pursuant to Part 15 of the FCC Rules.