Andon Health BG5 Part 15 Spread Spectrum Transmitter User Manual BG5 OM EN 20130124

Andon Health Co., Ltd Part 15 Spread Spectrum Transmitter BG5 OM EN 20130124

Manual

Page 1 of 27  For in vitro diagnostic use only Read instructions before use For self-testing   iHealthTMWireless Smart Gluco‐Monitoring System (BG5) OWNER’S MANUAL   Table of Contents   INTRODUCTIN ...............................................................................................................................2 PACKAGE CONTENTS.................................................................................................................2 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) .............................................6 What is Alternate Site Testing?.................................................................................................7 What is the Advantage of Alternative Site Testing? .................................................................7 When to Use Alternative Site Testing? .....................................................................................7 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
Page 2 of 27  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) .............................................................17 Reviewing Test Results ....................................................................................................  17 Online measurement mode:(with iOS device) .....................................................................18 REFERENCE VALUE OF THE IHEALTH WIRELESS SMART GLUCOSE METER.........18 COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS ....18 Before Going to the Lab .........................................................................................................19 While at the Lab......................................................................................................................19 Cleaning and Disinfection...............................................................................................................19 IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS......21 Maintenance and Storage of your Wireless SMART GLUCOSE METER...........................21 LIMITATIONS OF USE ................................................................................................................22 SYSTEM TROUBLE SHOOTING ..............................................................................................23 Result Readings ......................................................................................................................23 Error Message .........................................................................................................................23 Trouble Shooting.....................................................................................................................24 IMPORTANT INFORMATION REQUIRED BY THE FCC .................................................26   INTRODUCTIN   Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (BG5). 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. Due to its compact size and easy operation, you can use the iHealth Wireless Smart Gluco-Monitoring System (BG5) to easily monitor your blood glucose levels on your own, anywhere, any time.  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.   PACKAGE CONTENTS     z Wireless Smart Glucose Meter
Page 3 of 27  z Test Strips*        z Lancing device     z Clear alternate site testing device cap     z Lancets*           z Travel Case    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.
Page 4 of 27   SETUP REQUIREMENTS    The iHealth Wireless Smart Gluco‐Monitoring System (BG5) is designed to be used with the following iPod Touch ,iPad, iPhone models: iPod Touch 4 iPod Touch 5 iPhone 4S iPhone 4 iPhone 5 iPad2 iPad3 iPad4 iPad Mini The iOS version of these devices should be V5.0 or higher.    INTENDED USE    The iHealth Wireless Smart Gluco‐Monitoring System (BG5) should 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 only and should not be shared  • 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 (BG5) 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.   Control  Solutions  are  intended  for  use  with  the  Wireless  Smart  Gluco‐Monitoring  System  (BG5). Control Solutions can be used to check that the glucose  meter  and test strips  are  working properly and that the measurement is accurate. These Control Solutions contain a known amount of glucose,
Page 5 of 27  as  indicated  on  the  bottles.  If  you  need  to  purchase  additional  Control  Solution,  you  can  call  Customer Service at +1‐855‐816‐7705.     How the Test Works?    The  iHealth  Wireless  Smart  Gluco‐Monitoring  System  (BG5)  monitors  glucose  levels  by  measuring the amount of electrical currents that are generated when the glucose in your system reacts with the reagent of a test strip. The strength of the current produced by the reaction depends on the amount of  glucose  in  the  blood  sample.  The  glucose  meter  measures  the  current  and  converts  to  the corresponding blood glucose level.   IMPORTANT SAFETY INSTRUCTIONS     Please    carefully    read    the   following    information    before   using    the    iHealth   Wireless    Smart  Gluco‐Monitoring System (BG5). Always keep these instructions in a safe place for reference.    z Misuse of the Wireless Smart Gluco‐Monitoring System can cause electrocution, burns, fire and other hazards. 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.  z Do not  use  the Wireless  Smart Glucose Meter  if it  has  suffered  any  damage  or is  not  working properly. z  Keep  the  Wireless  Smart  Glucose  Meter  away  from  heat  at  all  times.  Do  not  let  the  Wireless  Smart Glucose Meter come into contact with surfaces that are hot to the touch.  z Do  not  block  test  ports or  place  the  Wireless  Smart  Glucose  Meter  on  soft  surfaces  that  may block them. Keep test ports free from lint, hair, debris, etc.
Page 6 of 27  z Do not place anything on top of the Wireless Smart Glucose Meter.  z Do not place foreign objects into any opening in the Wireless Smart Glucose Meter.  z Please make sure it is not used by children or people who cannot express their own volition to use it, and do not put the glucose meter in a place where it can easily be reached by children. z Do  not  use  the  Wireless  Smart  Glucose  Meter  where  aerosol  sprays  are  being  used or where oxygen is being administered. z Do not use in a manner not specified by the manufacturer.     IMPORTANT TESTING INFORMATION    z Severe dehydration and excessive water loss may cause results that are lower than actual values.  If  you  believe  you  are  suffering  from  severe  dehydration,  consult  a  healthcare  professional immediately. z 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. z Use  only fresh  whole  blood  samples  to  test  your  blood  glucose.  Using  other  substances  will result in inaccurate results. 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.   INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST)     There are limitations for doing AST. Please consult your healthcare professional before you conduct  AST.  The  Wireless  Smart  Gluco‐Monitoring  System  limits  usage  to  steady‐state  blood  glucose
Page 7 of 27    conditions only.    What is Alternate Site Testing?    Alternate  Site  Testing  (AST)  is  blood  glucose  self‐monitoring  using  a  blood  sample  collected  from somewhere other than the fingertips. The Wireless Smart Gluco‐Monitoring System (BG5) allows you to test on the palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing.                             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. Therefore, when testing blood glucose levels during or immediately after one of these , such as meals or exercise, take a blood sample from your fingertips only. AST should be done only during steady–state times when glucose levels are not changing rapidly.
Page 8 of 27  AST is suitable in the following instances:  z In a pre‐meal or fasting state (two hours or more after the last meal)  z Two hours or more after taking insulin  z Two hours or more after exercising    Caution:  AST  should  not  be  used  to  calibrate  continuous  glucose  monitoring  systems  (CGMs). Results from AST should not be used in insulin dose calculations. Do not use AST if: z You think your blood glucose is low  z You believe you may be hypoglycemic  z You are testing for hyperglycemia  z Your routine glucose results fluctuate often  z You are pregnant
Page 9 of 27                 PARTS AND DISPLAY INDICATORS     Glucose Meter
Page 10 of 27        Blood Glucose Test Strip    Each test strip is intended for single use only and should be discarded immediately after use Test  strips consist of the following parts:
Page 11 of 27      NOTE: Only use iHealth Blood Glucose Test Strip with the iHealth Wireless Smart Gluco-Monitoring System (BG5). 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.  Download the Free iHealth App Prior to first use, download and install the free iHealth App from the App Store. Use keyword search terms “iHealth,” “BG5” or” iHealth Gluco-Smart.”   2. Account Setup and Registration Follow the on-screen instructions to register and set up your personal account.   3. Connect the Glucose Meter to your iOS Device via Bluetooth Press and hold the Memory Button for 3 seconds to turn the meter on. Enable the Bluetooth function on your iOS device. When the model name “BG5xxxxxx” and “Not Paired” appears in the Bluetooth menu, select the model name to pair and connect. When the “ ” symbol appears, the meter is in Bluetooth communication mode. 4. Two-dimensional code scanning Please scan two-dimensional code on the test strip vial after establishing a Bluetooth connection, we will help you manage your test strip
Page 12 of 27    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.      Obtaining a Blood Sample   The detailed procedure reference iHealth Lancing Device     Apply Your Blood Sample    Apply your blood to the  blood sample area of the test strip, making sure the sample area  is  fully covered  with  your  blood  sample.  Please leave the test strip blood samples when the countdown begins    Read the Test Results   【更换显示示图需删除 CTL 标识】 After counting down to  “1”  the test result will appear on the meter display. 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 providers, do not deviate from these instructions on the basis of the result without first consulting your physician   Discard the Used Test Strips   Hold down the eject button to promote to the direction of the test strips, the test strips will leave a
Page 13 of 27                    blood glucose meter. Discard the used test strips directly into the waste container   Discard the Used Lancet              Discard  the  used  lancet  directly  into  a  container  designed  for  sharp  objects.  Always  wash  hands  thoroughly with soap and water after handling the meter, lancing device, test strips.  Note: Please consult a healthcare professional for interpretation of blood glucose measurements.    Online measurement mode:(with 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. If this is your IOS device's Bluetooth function in the open mode, then the blood glucose meter will automatically connect the IOS device, and enter the online measurement mode. Blood glucose meter line measurement mode only display the Bluetooth symbol.      Obtaining a Blood Sample   The detailed procedure reference iHealth Lancing Device     Apply Your Blood Sample    Apply your blood to the blood sample area of the test strip, making sure the sample area is fully  covered with your blood sample. Your iOS device will  beep when you should remove the test strip
Page 14 of 27                    from the blood sample   Read the Test Results     Your blood glucose results will be displayed on the iOS device.    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 providers, do not deviate from these instructions on the basis of the result without first consulting your physician.   Discard the Used Test Strips   Hold down the eject button to promote to the direction of the test strips, the test strips will leave a blood glucose meter. Discard the used test strips directly into the waste container     Discard the Used Lancet              Discard  the  used  lancet  directly  into  a  container  designed  for  sharp  objects.  Always  wash  hands  thoroughly with soap and water after handling the meter, lancing device, test strips.  Note: Please consult a healthcare professional for interpretation of blood glucose measurements.  For additional information, please visit: www.ihealthlabs.com    Control Solution    Control solution contains a known amount of glucose that reacts with test strips and is used to ensure that your meter and test strips are working together properly.
Page 15 of 27    Material needed: z iHealth Wireless Smart Gluco-Monitoring System (BG5) 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 meter has been dropped or damaged    Performing an Offline Control Solution Test with Meter Alone (not using iOS device)   When taking a Control Solution Test with meter alone, it is important to set the test mode to “CTL,” so that the result will not be mixed up with your regular test results. Control Solution Test results will not be saved in the meter’s memory. Please follow the instructions below.   Step 1: Insert the test strip to turn on the meter Insert the test strip in the meter’s Strip Port, and wait for the Blood Sample Symbol to appear in the meter display.  Step 2: Press the Memory Button to turn on the control (“CTL”) mode. When the “CTL” symbol appears, the meter is in control ode and will not save this test results in memory.   Step 3: Press the “Memory Button” again to turn off the “CTL” mode and switch back to the regular testing mode.  When the “CTL” symbol disappears from the meter display, the meter is in regular testing mode and subsequent tests will not be treated as a control solution test.   Step 4: Apply Control Solution • Shake the Control Solution vial before each use.  • Squeeze a drop of Control Solution and place it in the vial cap. For better results, it is recommended that you use the second drop of the Control Solution (discard the first drop).
Page 16 of 27    • 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.   The result of the Control Solution test should be within the range  printed  on  the  test  strip  vial  label.  If  the  test  result  falls  outside  the specified range, repeat the test, carefully following the steps above.   I Performing an Online Control Solution Test (with iOS device)  Step 1: Launch the App  Step 2: Tap the “CTL” button to switch to Control (“CTL”) mode  Step 3: Follow Steps 1-4 of “Performing an Offline Control Solution Test”  Step 4: the Control Solution test result will appear on the iOS device.   Out-of-Range Results   Results falling outside the specified range may be caused by: •   Error in performing the test •   Expired or contaminated Control Solution •   Expired or contaminated test strip •   iHealth Wireless Smart Gluco-Monitoring System (BG5) 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 +1855-816-7705 for assistance.  To purchase additional Control Solution,  call iHealth Labs Customer Service at +1855-816-7705.    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.
Page 17 of 27           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.     METER MEMORY   Offline measurement mode:(not using iOS device)   The Wireless Smart Glucose Meter stores up to 500 of your most recent blood glucose test results along with their respective dates and times.  Reviewing Test Results  1. Press and release “Memory Button” on the meter.  Press the Memory Button to view the test results stored in the meter. The first reading you’ll see is your most recent blood glucose result.            . Note: When  the  meter  memory is  full,  the  oldest  test  result  will  be  deleted automatically, and the newest test result will be saved.   2. Exit the Memory Mode  When  you  reach  the  last  test  result,  the  word  “End”  will  appear,  and  the meter will turn off automatically. If you do not operate the meter in 30 seconds, it will turn off automatically.
Page 18 of 27       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. If the Bluetooth function disconnected, the meter will automatically shut off.    REFERENCE VALUE OF THE IHEALTH WIRELESS SMART GLUCOSE METER    Time of day People without diabetes Fasting and before meals <100 mg/dL 2 hours after meals <140 mg/dL  Source:  (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 your healthcare provider to determine a target range that is best for you.     COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS     The Wireless Smart Glucose Meter 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 Wireless Smart Glucose Meter 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 Wireless Smart Glucose Meter and laboratory results, follow the guidelines below.
Page 19 of 27  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.  z Use fresh capillary blood only.       Cleaning and Disinfection    The cleaning and disinfection is absolutely necessary for the test procedure, because cleaning can insure the meter works well (for example, display will be clear to see after cleaning); and disinfection can avoid the infection to you or to the other people, and the cross‐infection. We strongly  warn that the protective cover  is needed when  use  the  iOS  device to  test  the blood glucose  ,  the  meter  and  lancing  device  should  be  cleaned  and disinfected  following  use. And we suggest you use the following product: CaviWipes (EPA registration number  :46781‐8).  The CaviWipes, with Isopropanol and Diisobutyl‐phenoxy‐ethoxyethyl dimethyl benzyl ammonium chloride  as  the  active  ingredient,  have  been  shown to  be  safe  for  use  with  the BG5  Blood  Glucose meter and lancing device. You  can  purchase  this  product  according  to  the  following  information:  visit  the  web  site www.metrex.com or contact Metrex at 800‐841‐1428 for product or technical information. The meter  and the lancing  device  are  for  single‐patient  use, if user  test  5‐6  times  every  day, the devices  may  be  cleaned  and  desinfected  5‐6  times  per  day,  as  a  result,  there  will  be  11000  cycles cleanings plus disinfections (1 cycle = 1 cleaning + 1 disinfection) for the meter and the device during its 5 years life cycle.
Page 20 of 27    1 After the test, the user should clean and wash hands, and then put on the disposable glove.  2 Use the  Cavi WipesTM (Metrex®   RESERCH CORPORATION,EPA Reg. NO. 46781‐8, EPA  Est. No.  56952‐WI‐001)      to  clean  and disinfect  the  meter’s  housing  and  lens,.Take  one  wipe  to  clean  the meter,  including  its  front  and back  for  10  seconds  for  cleaning  until  there  is no soil on  the surface. Then disinfect the meter with another wipe and keep the surface wet for 2 min. 3 With the same method use the Cavi WipesTM (Metrex®  RESERCH CORPORATION,EPA Reg. NO.  46781‐8, EPA Est. No. 56952‐WI‐001)     to clean and disinfect the lancing device..  4 Take off the glove and the protective cover    Note:  1. Each disinfection step requires a pre‐cleaning step.  2. The users  should wash hands thoroughly with  soap and water  after  handling the meter, lancing device, or test strips. 3. The meter can only be cleaned and disinfected with the disinfecting towelette on the surface of the device, users can not insert the disinfecting towelette into the test strip port and the metal contector, and else the performance of the meter may be influenced. 4. Please refer to the following linkage for detail 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  5. If you have any questions you can call the number+1‐855‐816‐7705  6. Table: A list of the signs of potential deterioration (Physical and in performance)  What do you see? What to do? The device does not work,for example the iOS device can’t begin testing when meter is connect with iOS device or when test strip is Stop  using  and  contact  local  customer  services  or  place  of purchase    for    assistance,    or    toll    free    service    hotline: +1‐855‐816‐7705
Page 21 of 27   inserted into the meter.  Discoloration of the meter casing or lancing device,for example it is difficult to read the labeling information. Stop  using  and  contact  local  customer  services  or  place  of purchase    for    assistance,    or    toll    free    service    hotline: +1‐855‐816‐7705 Corrosion, crazing, embrittlement, Cracking of the meter casing or lancing device Stop  using  and  contact  local  customer  services  or  place  of purchase    for    assistance,    or    toll    free    service    hotline: +1‐855‐816‐7705      IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS    1.  Model: BG5  2.  Machine size: 0.38’’× 1.35’’× 0.75’’ (9mm × 34.5mm ×19mm)  3.  Measuring method: Amperometric technology using glucose oxidase  4.  Result range: 20 mg/dL ~600 mg/dL (1.1 mmol/L ~33.3mmol/L)  5.  Power source: DC 3.7V ,     li‐ion 250mAh  6.  Wireless communication:Bluetooth V3.0+EDR Class2 SPP Frequency Band:2.402‐2.480GHz 7.  Storage condition:     Test Strips     39.2° F~86° F (4° C~30° C), Humidity  <  80% RH  8.  Storage condition:     WIRELESS Smart Glucose Meter     ‐4° F ‐ 131° F (‐20° C~55° C); Humidity  <80%RH  9.  Operating conditions: 50°F~104°F (10° C~40° C)  10.    Blood source: Fresh capillary whole blood  11.     Blood volume: Min. 0.7 micro liter  12.    Life span: Five years     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
Page 22 of 27  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.      LIMITATIONS OF USE    z The iHealth Wireless Smart Glucose Meter is not intended for use on newborns.  z The iHealth Wireless Smart  Glucose  Meter is  not  intended for  use on  artery  blood, serum and plasma. z The  iHealth   Wireless   Smart   Glucose   Meter   should   only  be   used   with   iHealth  test  strips  (AGS‐1000I).  z The  iHealth  Wireless  Smart  Glucose  Meter  can  be  used  up  to  an  altitude  of  3276  meters  (10744feet).  z 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, etc. These substances do not affect test  results  in  normal  concentration  but  may  affect  test  results  in  high  concentrations.  Do  not use haemolysis samples, icterus samples or high lipemia samples. z Patients undergoing oxygen therapy may yield falsely lower results.  z Not for use for patients in a hyperglycemic‐hyperosmolar state, with or without ketosis.  z Not for use on critically ill patients.  z Not to be used for patients who are dehydrated, hypertensive, hypotensive or in shock.  z 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  comparison  of  the  iHealth  Wireless  Smart  Gluco‐Monitoring  System  to another monitoring system known to be well maintained and monitored by a healthcare provider.
Page 23 of 27  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. Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances.  Result Readings    MESSAGE WHAT It Means? ACTION    Blood    glucose    level    is lower  than  20mg/dl (1.1mmol/L) The message indicates very low blood glucose. Consult with your healthcare professional.  Blood  glucose  level  is higher  than  600  mg/dl (33.3mmol/L) The message indicates severe hyperglycemia (high blood glucose). Seek immediate medical assistance.   Error Message    MESSAGE WHAT It Means? ACTION    RE0 The   meter’s   battery   has insufficient power. Please  charge  the battery.    Problems  have  occurred that are related to test strip use. Please  use  a  new  test strip and re-test.
Page 24 of 27      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 temperature  is  lower  than 50℉ Please  test  at  a  higher environmental temperature.  The  environmental temperature is higher than 104℉ Please  test  at  a  lower environmental temperature. Erd The test strip is 0 Please use the new test strip. ErE The test strip has expired Please use the new test strip.     Trouble Shooting   Problems Possible Causes Solutions Display  remains  blank after  the  test  strip  has been  inserted  into  the meter. 1.  Battery  power  is  too low for use. 2.  Too  much  time  has passed    between inserting the test strip and  performing the test. 3. Test strip has not been fully  inserted  into  the Meter. 1.  Charge  the battery 2.  Reinsert  the test  strip  into  the meter. 3.  Reinsert  the test  strip  into  the meter,  pressing firmly.
Page 25 of 27         Test  results  are inconsistent  or  Control Solution  test  results  are not  within  the  specified range. 1.   Not   enough   sample in the Test Strip. 2.  Test  strip  or  Control Solution has expired. 3.  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. 4. 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. Re-test with a new Test  Strip  or  new Control Solution 3.  Perform  a  Control Solution    test using  a  new  Test Strip. If the results are  still    out    of range,  replace with  new  vial  of Test Strips. 4.  Bring  the  system to    a room-temperature environment  and wait approximately 30  minutes  before performing  a  new test. The  meter  countdown did not start. Test strip has not been inserted correctly. Use  a  new  Test Strip and redo the test.   In vitro diagnostic medical device   Serial number            Consult instructions for use           Consult instructions for use            Manufacturer     Environmental  Protection–  Waste  electrical  products  should  not  be  disposed  of  with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.       Authorised representative in the European Community
Page 26 of 27         FCC ID:ZRYBG5      Bluetooth sign   Keep dry    Complies with IVD98/79/EC requirements   iHealth is a trademark of iHealth Lab Inc.   “Made for iPod” “Made for iPad”and “Made for iPhone” mean that an electronic accessory has  been  designed to  connect  specifically to iPod,  iPad,iPhone, respectively,  and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPod,iPad, iPhone may affect wireless performance. iPod Touch ,iPad,iPhone are trademarks of Apple Inc., registered in the U.S. and other countries.      Manufactured for iHealth Lab Inc. 719 N. Shoreline Blvd., Mountain View, CA 94043, USA +1-855-816-7705 (toll-free from PST 8:30-17:30 of MON to FRI) www.ihealthlabs.com   ANDON HEALTH CO., LTD.  No. 3 Jin Ping Street, Ya An Road, Nankai District, Tianjin 300190, China  Tel: +86‐22‐60526161  EC   REP Lotus Global Co., Ltd.  15 Alexandra Road, London UK, NW8 0DP  Tel: +0044‐20‐75868010 Fax: +0044‐20‐79006187   IMPORTANT INFORMATION REQUIRED BY THE FCC     This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two 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.
Page 27 of 27  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. 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.   Radiofrequency radiation exposure Information: This  equipment  complies  with  FCC  radiation  exposure  limits  set  forth  for  an  uncontrolled environment. This equipment should be installed and operated with minimum distance of [20] cm between  the  radiator  and  your  body.  This  transmitter  must  not  be  co‐located  or  operating  in conjunction with any other antenna or transmitter.  Cet  équipement  est  conforme  aux  limites  d'exposition  aux  radiofréquences  définies  par  Industrie Canada  pour  un  environnement  non  contrôlé.  Cet  équipement  doit  être  installé  et  utilisé  avec  un minimum de 20 cm de distance entre le dispositif et l'utilisateur ou des tiers.  NOTICE: Changes or modifications made to this equipment not expressly approved by (manufacturer name) may void the FCC authorization to operate this equipment.   This product complies with Industry Canada. IC: RSS‐210 This product is approved in accordance to R&TTE directive transmitter. IC NOTICE This device complies with Industry Canada licence‐exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.  Le  présent  appareil  est  conforme  aux  CNR  d'Industrie  Canada  applicables  aux  appareils  radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.

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