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This product is approved in accordance to RED directive. 

ELECTROMAGNETIC COMPATIBILITY INFORMATION 

Table 1 For All ME EQUIPMENT and ME SYSTEMS 

Guidance and manufacture’s declaration - electromagnetic emissions 

The BG5S is intended for use in the electromagnetic environment specified below. 

The customer or the user of the BG5S should assure that it is used in such an environment. 

Emissions test 

Compliance 

Electromagnetic environment - guidance 

RF emissions 

CISPR 11 

Group 1 

The BG5S uses RF energy only for its internal function. Therefore, 

its  RF  emissions  are  very  low  and  are  not  likely  to  cause  any 

interference in nearby electronic equipment. 

RF emissions 

CISPR 11 

Class B 

The  BG5S  is  suitable  for  use  in  all  establishments,  including 

domestic establishments and those directly connected to the public 

low-voltage power supply network that supplies buildings used for 

domestic purposes. 

Harmonic emissions 

IEC 61000-3-2 

Class A 

Voltage fluctuations/ 

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 electromagnetic environment specified below. The customer or the user 

of the BG5S should assure that it is used in such an environment. 

IMMUNITY test 

IEC 60601test 

level 

Compliance level 

Electromagnetic environment - 

guidance 

Electrostatic 

discharge (ESD) 

IEC 61000-4-2 

± 6 kV contact 

± 8 kV air 

± 6 kV contact 

± 8 kV air 

Floors  should  be  wood,  concrete  or 

ceramic tile. If  floors are covered  with 

synthetic 

material, 

the 

relative 

humidity should be at least 30 %. 

Electrical fast 

transient/burst 

IEC 61000-4-4 

±2kV for power 

supply lines 

±1kV for 

input/output lines 

± 2 kV for power 

supply lines 

±1kV for input/output 

lines 

Mains  power  quality  should  be  that  of 

a  typical  commercial  or  hospital 

environment. 

Power frequency 

(50/60 Hz) 

magnetic field 

IEC 61000-4-8 

3 A/m 

3 A/m 

Power 

frequency 

magnetic 

fields 

should  be  at  levels  characteristic  of  a 

typical location in a typical commercial 

or hospital environment. 

NOTE: U

T

 is the a.c. mains voltage prior to application of the test level. 

 

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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