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INTRODUCTION 

Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (the iHealth system). This 

manual provides important information to help you use the system properly. Before using this product, 

please read the Owner’s Manual thoroughly. 

INTENDED USE 

The  iHealth  Wireless  Smart  Gluco-Monitoring  System  (BG5S)  is  intended  to  be  used  for  the  quantitative 

measurement  of  glucose  (sugar)  in  fresh  capillary  whole  blood  samples  drawn  from  the  fingertip,  palm, 

forearm, upper arm, calf or thigh. 

The iHealth Wireless Smart Gluco-Monitoring System (BG5S) is intended to be used by a single person and 

should not be shared. 

The  iHealth  Wireless  Smart  Gluco-Monitoring  System(BG5S)  is  intended  for  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  (BG5S)  should  not  be  used  for  the  diagnosis  of  or 

screening of diabetes or for neonatal use. 

Alternative  site  testing  should  be  done  only  during  steady  -  state  times  (when  glucose  is  not  changing 

rapidly). 

The AGS-1000I & EGS-2003 test strips are for use with the iHealth BG5S meter to quantitatively measure 

glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, 

calf or thigh. 

The  iHealth  control  solutions  are  intended  for  use  with  the  iHealth  BG5S  Wireless  Smart  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 indicated on the bottles.   

The  iHealth  Gluco-Smart  App  is  the  application  for  the  iHealth  Gluco-Monitoring  System,  and  is  used  for 

data extraction and analysis.   

In  order  to  use  the  iHealth  BG5S  Wireless  Smart  Gluco-Monitoring  System,  a  compatible  Android  or  iOS 

mobile device with the necessary mobile application installed is required. 

IMPORTANT SAFETY INSTRUCTIONS 

Please  read  the  following  information  carefully  before  using  the  iHealth  system.  Always  keep  these 

Summary of Contents for BG5S

Page 1: ...iHealth Wireless Smart Gluco Monitoring System Model BG5S OWNER S MANUAL For in vitro diagnostic use only Read instructions before use for self testing...

Page 2: ...14 What Is Alternative Site Testing 14 What Is the Advantage of Alternative Site Testing 15 When Should You Use Alternative Site Testing 15 IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS 16 PERFO...

Page 3: ...d not be used for the diagnosis of or screening of diabetes or for neonatal use Alternative site testing should be done only during steady state times when glucose is not changing rapidly The AGS 1000...

Page 4: ...on top of the iHealth system Do not place foreign objects into any opening in the iHealth system Do not use the meter in a manner not specified by the manufacturer All parts of the iHealth system are...

Page 5: ...ur AST results do not match the way you feel your routine glucose results fluctuate often Do not use AST results to calibrate a continuous glucose monitor CGM Do not use AST results for insulin dosing...

Page 6: ...ary from country to country Please refer to the package contents listed on the package you purchased 1 iHealth Wireless Smart Glucose Meter BG5S 2 iHealth Test Strips 3 iHealth Lancing Device 4 Lancet...

Page 7: ...and Level III Please note that only the level II control solution may be included in the your kit The level I and level III control solution are not included in the your kit You can call iHealth Labs...

Page 8: ...705 8 30AM 5 30PM PST Monday to Friday except holidays Parts and Displays iHealth Wireless Smart Glucose Meter BG5S iHealth Test Strips Use only iHealth test strips with the meter Each test strip can...

Page 9: ...0 devices for example iPhone 4S iPhone 5 iPhone 5c iPhone 5s iPhone 6 iPhone 6 Plus iPhone SE iPod Touch 5G iPod Touch 6G iPad 3 iPad 4 iPad Air iPad Mini 2G iPad mini 3G iPad mini 4G iPad Air 2 Works...

Page 10: ...e lower than actual values may occur in individuals who are in a hyperglycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters If you...

Page 11: ...login your app Note2 You can create an iHealth ID by following instructions in your app or go to www ihealthlabs com to create PROCESS 3 Activate your meter Your meter is powered by a built in recharg...

Page 12: ...ncing device against the site to be lanced Press the release button to puncture the site Gently squeeze your finger until a drop of blood forms Wipe away the first blood drop and squeeze until a secon...

Page 13: ...elps 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...

Page 14: ...SS 1 above PROCESS Login in your app Same to PRCESS 2 above PROCESS Activate your meter Same to PRCESS 3 above PROCESS Confirm your test strip model Keeping your meter is closed to your Android or iOS...

Page 15: ...End will appear and the meter will shut off automatically Similarly the meter will shut automatically when it is idle for three minutes CLEANING AND DISINFECTION The cleaning and disinfection is absol...

Page 16: ...CAL AND PERFORMANCE DETERIORATION If you encounter one of the following circumstances stop using the meter and contact local customer services or the place of purchase for assistance or call the toll...

Page 17: ...tely When Should You 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 cap...

Page 18: ...t of glucose that reacts with test strips and is used to check that your meter and test strips are working together properly Materials needed to perform a control solution test iHealth Wireless Smart...

Page 19: ...ply control solution onto a strip Step A 3 Read and compare the results After the meter counts down to 1 the control solution test result will appear on the meter display The result of the control sol...

Page 20: ...rform 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 your iHealth System to the lab While at the...

Page 21: ...Dropping or throwing the meter may cause damage Always wash your hands with soap and water and rinse and dry them completely before handling the iHealth Wireless Smart Glucose Meter BG5S and test str...

Page 22: ...use such as Test strip may be wet or damaged Test strip may have been removed too soon You applied more blood Re test using a new test strip The environmental temperature is lower than 50 F 10 C The...

Page 23: ...r 3 Reinsert the test strip into the meter pressing firmly Test results are inconsistent or control solution test results are not within the specified range 1 Not enough sample in the test strip 2 Tes...

Page 24: ...ectronic accessory has been designed to connect specifically to the iPod Touch iPad and or iPhone respectively and has been certified by the developer to meet Apple performance standards Apple is not...

Page 25: ...ical 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 Authorised representative in t...

Page 26: ...tion 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...

Page 27: ...ndustry Canada regulations this radio transmitter may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potential radio inter...

Page 28: ...ons flicker emissions IEC 61000 3 3 Complies Table 2 For All ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The BG5S is intended for use in the electromag...

Page 29: ...itters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the followin...

Page 30: ...an be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NO...

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