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instructions in a safe place for reference.   

 

Misuse of the iHealth system can cause electrocution, burns, fire, and other hazards.   

 

The meter and lancing device are for single patient use. 

 

Do not use either item on multiple patients.   

 

Do not share the meter or lancing device with anyone, including other family members.   

 

Do not place the iHealth system in or near liquid. 

 

The iHealth system can be used up to an altitude of 3276 meters (10744 feet). 

 

Use the iHealth system only for the purpose described in the Owner’s Manual. 

 

Use only accessories that are supplied by the manufacturer. 

 

Do not use the iHealth system if it has sustained any damage or is not working properly. 

 

Keep the iHealth system away from heat at all times. Do not let the iHealth system come into contact 

with surfaces that are hot to the touch. 

 

Do not block test port or place the iHealth system 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 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  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

 

LIMITATIONS OF USE 

The iHealth system is not intended for use on neonates. 

 

The iHealth system is not intended for use on artery blood, serum, and plasma. 

 

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 

Содержание BG5S

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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