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Smart Meter iGlucose, Owner'S Booklet

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i

Glucose

®

 

getting ready for testing

Before performing a blood glucose test, prepare the items below:
• iGlucose® Blood Glucose Meter 
• iGlucose Blood Glucose Test Strips (Please check the 
expiration date on the test strip vial. Do not use expired  
test strips).
• iGlucose Lancing Device
• Sterile Lancet

Summary of Contents for iGlucose

Page 1: ...Owner s Booklet...

Page 2: ......

Page 3: ...lucose Monitoring System User Manual iGlucose is a trademark of Smart Meter LLC iGlucose Blood Glucose Monitoring System is manufactured by Bionime Corporation No 100 Sec 2 Daqing St South Dist Taichu...

Page 4: ...intended to be used by a single person and should not be shared The iGlucose System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home as an aid to m...

Page 5: ...make sure the test results are accurate See Performing a Quality Control Test The iGlucose Meter can only be used with the iGlucose Blood Glucose Test Strips Other test strips should not be used unde...

Page 6: ...Glucose Blood Glucose Meter and iGlucose Test Strips are exposed to a substantial change in temperature please wait 45 minutes before measurement The iGlucose System is not for use on neonates All par...

Page 7: ...st results Certain conditions may cause your blood level of uric acid to rise These conditions include gout or kidney disease This means that when the uric acid concentration in your blood is greater...

Page 8: ...ne Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick D...

Page 9: ...od glucose test strip turning the meter on off charging the battery replacing the battery when needed synchronizing the date and time automatically setting the time and date manually setting the forma...

Page 10: ...control test be performed required items for quality control tests performing a quality control test inserting the test strip understanding control test results recalling test results obtaining readi...

Page 11: ...iGlucose 11...

Page 12: ...ucose the iGlucose blood glucose monitoring system Your iGlucose Blood Glucose Monitoring System consists of several items Please identify each item learn its name and how it is used 1 4 7 10 11 2 5 8...

Page 13: ...to produce an electrical current which is read by the meter and is converted to the corresponding glucose level in the sample The glucose result is then displayed on the meter within 5 seconds 1 iGlu...

Page 14: ...14 iGlucose the iGlucose blood glucose monitoring meter Product name Battery Cover Meter Serial Number Up Button Home Button Display Window Down Button Test Strip Port Sim card IMEI Number...

Page 15: ...ery is low and must be recharged Indicates that the cellular network has connection Indicates when to apply a blood drop Indicates when to apply a control solution drop Indicates a meal marker A full...

Page 16: ...ses should not be used for testing and should be discarded Do not reuse iGlucose Test Strips Do not use expired iGlucose Test Strips See expiration date on Test Strip vial Sample Port Apply a drop of...

Page 17: ...iGlucose Test Strips between 39 86 F or 4 30 C and in a location 10 90 relative humidity Do not expose to direct sunlight or heat Storage of strips near bleach as well as bleach containing products w...

Page 18: ...screen along with the message Charging Cannot Perform Glucose Test The blue light remains on while charging continues It may take 2 3 hours to fully charge When charging is complete the battery icon...

Page 19: ...Please follow the local regulations to properly recycle the rechargeable battery There is risk of explosion if the battery is replaced by an incorrect type Remove the old battery Install the new batt...

Page 20: ...ice 2 Scroll to the Date and time option by using the or button and press the Home button to select The Date and time menu appears 3 Scroll to the Set Date option by using the or button and The date a...

Page 21: ...the or button and press the Home button to select The hour appears Use the Settings or button to change the hour as needed Press the Home button to select and move on to the minute 7 Scroll using the...

Page 22: ...the Settings menu press the or button to scroll to the Back option and press the Home button to select and exit the menu setting preferred meter sound volume 1 Press briefly the button on the device...

Page 23: ...Turn the meter on by pressing and holding the Home button One of the two apple icons will appear on the screen either the Before Meal or the After Meal icon If the icon shown is not what you desire p...

Page 24: ...performing a blood glucose test prepare the items below iGlucose Blood Glucose Meter iGlucose Blood Glucose Test Strips Please check the expiration date on the test strip vial Do not use expired test...

Page 25: ...will be used later to dispose of the used lancet 5 Replace the depth adjustable cap firmly 6 Choose a depth of penetration by rotating the top portion of the depth adjustable cap until your desired s...

Page 26: ...26 iGlucose...

Page 27: ...ood Glucose Test Strip from the vial Close the vial cap immediately 1 Hold the iGlucose Test Strip between your thumb and middle finger with the view window facing you dark side of the sample port fac...

Page 28: ...ss the release button as indicated in the drawing below 4 The meter goes through an internal check that takes 3 seconds Wait until a blood drop icon and Apply a drop of blood message appears on the di...

Page 29: ...ve 3 0 L might contaminate the test strip port and the meter while blood sample size below 0 75 L may cause an inaccurate result or may prevent a meter reading An error code will be displayed if the s...

Page 30: ...rip and repeat with a new iGlucose Blood Glucose Test Strip Please see section below on View Appearance of Blood on the Strip The meter will now count down from 5 to 0 and will display your blood gluc...

Page 31: ...into the protective lancet cover See drawing below Hold the release button of the lancing device in one hand and pull on the plunger with the other hand to safely eject the used disposable lancet See...

Page 32: ...e professional s instructions and discard used strips properly Healthcare professionals should evaluate their patients technique regarding the use of the iGlucose Blood Glucose Monitoring System regul...

Page 33: ...of their true blood glucose level 6 out of 6 times Difference range between the true blood glucose level and the iGlucose Meter result Difference range between the true blood glucose level and the iGl...

Page 34: ...e Blood Glucose Meter performs an internal check If the blood drop icon and the message are NOT showing on the screen do not apply a sample to the test strip as it will result in an error message Reco...

Page 35: ...this range are obtained You can also run a quality control test with the Rightest Control Solution GC550 to check your iGlucose Meter and iGlucose Test Strip Refer to Performing a Quality Control Test...

Page 36: ...ween 20 and 600mg dL If the test result is below 20 mg dL LO will appear on the screen Please repeat your test with by a new test strip If you still get a LO result contact your healthcare professiona...

Page 37: ...sses the quality control test and your iGlucose System is working properly Control Solution Range Example of Control Solution Range printed on your test strip vial label when should a quality control...

Page 38: ...months after opening the bottle or until the expiration date printed on the label of the control solution whichever comes first Example After use wipe the top of the bottle cap with a clean wet tissue...

Page 39: ...press the Home button to select The Control solution screen appears with the message Control solution testing only do not test blood 3 Take one iGlucose Blood Glucose Test Strip from the vial and clos...

Page 40: ...t your meter will automatically turn on once the strip is inserted and the message Strip Inserted will be displayed 3 The meter goes through an internal check that takes 3 seconds Wait until a Control...

Page 41: ...Shake the bottle of Rightest Control Solution GC550 well before opening the cap Remove the bottle cap and place it on a flat surface b Place a drop of control solution onto the top of the cap See draw...

Page 42: ...ution test result will be shown with the control solution icon next to it Compare your quality control test result to the control solution range printed on the iGlucose Blood Glucose Test Strip vial l...

Page 43: ...message Apply a drop of control solution The iGlucose Blood Glucose Meter performs an internal check that takes 3 seconds Touching the control solution to the sample port before prompted will result...

Page 44: ...g System is working correctly Example of control solution range printed on your test strip vial label These ranges may vary depending on the test strip lot that is in use Possible reasons why your Con...

Page 45: ...omatically store a maximum of 500 test results with time and date If your meter has stored500results thenewesttestresultwillreplacetheoldestone The iGlucose Blood Glucose System maintains in the devic...

Page 46: ...the device memory of each blood glucose reading for up to 500 readings To obtain the list of previous blood glucose readings Press the button on the right side of the device The Averages menu appears...

Page 47: ...ined with blood control solution or any liquid please use a clean damp cloth listed below to clean it immediately Do not immerse in water Perform a quality control test to ensure the iGlucose Blood Gl...

Page 48: ...ice should be cleaned before being disinfected If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disi...

Page 49: ...he meter thoroughly Note All blood and body fluids should be cleaned from surface before performing the disinfecting procedure 2 Allow the surface to remain wet for 2 minutes 3 Allow to air dry Please...

Page 50: ...o clean any possible dirt dust blood and other body fluids To disinfect the iGlucose Lancing Device 1 Take another disinfecting wipe and wipe the iGlucose Lancing Device thoroughly Note All blood and...

Page 51: ...eter and or lancing device if any of the following occur Thin silver streaks appear on the screen The screen becomes cracked soft dissolved brittle or swollen You are unable to turn on off your meter...

Page 52: ...strip in the correct way Use correct brand of strip Problem Cannot turn on device Part of the display is not working Meter does not produce sounds No response when charging meter Cannot insert strips...

Page 53: ...curate Move to an area with temperature between 50 F to 104 F 10 C to 40 C and wait 45 minutes Do not artificially heat or cool the device Repeat the test with a new test strip A blood sample was appl...

Page 54: ...you do not see the error message again your meter is functioning properly and able to perform a test The applied blood sample volume is insu cient Discard the used strip and repeat the test using a ne...

Page 55: ...er thereisnoguaranteethatinterferencewillnotoccurinaparticular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the eq...

Page 56: ...ry charge without use of data transmission Number of uses is reduced and varies when data is transmitted Meter Dimensions 104 mm 49 8 mm 16 5 mm Meter Weight 85 0 5 g with battery Monitor Color LCD Mo...

Page 57: ...complete and return the enclosed warranty card Different models have different specifications This warranty applies only to the iGlucose Blood Glucose Monitoring System other models are not covered w...

Page 58: ...g dL Fasting 100 mg dL Two hours after meals 140 mg dL References 1 American diabetes association Standards of medical care in diabetes 2016 2016 39 supp 1 diabetes Care S16 Component Manufacturer Inf...

Page 59: ...one Insulin Pills Log book date From To In case of emergency contact DATE M T W T F S S Breakfast Blood Glucose Insulin Medication Lunch Blood Glucose Insulin Medication Dinner Blood Glucose Insulin M...

Page 60: ...60 iGlucose Warranty Card PLACE STAMP HERE Name Tel Address Distributor name and address Serial No Model Date of Purchase Please present this card for product replacement...

Page 61: ...ing System User Name Emergency Contact Phone No Blood Type Doctor Hospital I am a person with diabetes If you find me in a coma or stupor please contact nearest emergency services immediately Or call...

Page 62: ...62 iGlucose IFU01 ENv2 1218 Manufactured for SMART METER LLC 201 E Kennedy Blvd Suite 880 Tampa FL 33602 www iglucose com...

Page 63: ...iGlucose 63...

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