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For in vitro diagnostic use only

Read instructions before use for self-testing

Align Gluco-Monitoring System (BG1)

OWNER’S MANUAL

Содержание BG1

Страница 1: ...For in vitro diagnostic use only Read instructions before use for self testing Align Gluco Monitoring System BG1 OWNER S MANUAL ...

Страница 2: ... SYSTEM THE IHEALTH SYSTEM CARE AND MAINTENANCE PERFORMING A BLOOD GLUCOSE TEST WITH ALTERANTE SITE IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS TEST STRIP VIAL LABEL iHealth Align GLUCO MONITORING SYSTEM SPECIFICATIONS LIMITATIONS OF USE SYSTEM TROUBLESHOOTING WARRANTY INFORMATION EXPLANATION OF SYMBOLS IMPORTANT INFORMATION REQUI...

Страница 3: ...ing outside the body in vitro diagnostic use as an aid to monitor the effectiveness of diabetes control The iHealth system should not be used for the diagnosis of or screening for diabetes or for neonatal use Alternative Site Testing AST should be performed only during steady state times when glucose levels are not changing rapidly iHealth Blood Glucose Test Strips AGS1000I are intended for use wi...

Страница 4: ...ing on top of the glucose meter Do not place foreign objects into any opening in the glucose meter Do not use the glucose meter in a manner not speciﬁed by the manufacturer When not in use please disconnect the glucose meter from the mobile device All parts of the iHealth system are considered biohazards and can potentially transmit infectious diseases even after you have performed cleaning and di...

Страница 5: ...000I Absorbent hole Conﬁrmation window Test strip handle Contact bars Clear Cap for Alternate Site Testing Cocking Handle Release Button Depth Indicator Window White Cap for ﬁnger testing Lancet Removal Handle Lancet iHealth Control Solution Level II Control Solution Lancet Cap 3 ...

Страница 6: ...is based on the measurement of electrical currents generated by the reaction of glucose with the reagent of the test strip The iHealth system measures the current and converts it to the corresponding blood glucose level The strength of the current produced by the reaction depends on the amount of glucose in the blood sample IMPORTANT TEST INFORMATION Severe dehydration or excessive water loss may ...

Страница 7: ...nload the free iHealth Gluco Smart App to your mobile device from the Apple App Store or Google Play Store Follow the on screen instructions to create your iHealth account Access the iHealth Cloud Account Your iHealth account also gives you access to the free and secure iHealth cloud service Go to www ihealthlabs com and click Sign In for access once your account has been created Scan to Code the ...

Страница 8: ...iHealth logo on the meter Step 4 Prepare the lancing device Snap off the lancing device cap Insert a new lancet ﬁrmly into the lancing device holder cup Twist the lancet cover off Replace the lancing device cap Set the lancing level to your desired pressure level Cock the handle until it clicks 6 Step 5 Obtain a blood sample Press the lancing device against the site to be lanced and then press the...

Страница 9: ... 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 providing Do not deviate from these instructions on the basis of the result without ﬁrst consulting your physician Step 8 Discard the used test strip and lancet Remove the used test strip from th...

Страница 10: ...me of day People without diabetes Fasting and before meals 2 hours after meals 100 mg dL 140 mg dL 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 a healthcare profess...

Страница 11: ...ng the back of the cover down When the Battery is low indicator appears within the app replace the battery to ensure successful and accurate measurements Disposal 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 Cleaning And Disinfecting the Meter and Lancing Device The cleaning...

Страница 12: ...e You can purchase this product from the suppliers listed below 1 Visit the website www metrex com or contact Metrex at 800 841 1428 for product or technical information 2 Visit the website http www endochoice com Equipment search wipe The meter and lancing device are validated to withstand 11 000 individual tests and 11 000 cleanings over their 5 year life spans Steps for cleaning and disinfectin...

Страница 13: ...instructions to perform an Alternate Site Test Upper Arm Forearm Palm Finger Calf Thigh 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 AST should be used only during steady state times when blood glucose levels are not changing rapidly You may perform Alternate Site Te...

Страница 14: ... vial of test strips You suspect the meter and or test strips are not working properly Your blood glucose test results are not consistent with your expectations or you think the results are not accurate Practicing the testing process After the test strips are exposed to extreme conditions The meter has been dropped or damaged Out of Range Results Results falling outside the speciﬁed range may be c...

Страница 15: ...ose meter may differ somewhat from your laboratory results due to normal variation The iHealth system 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 iHealth system and laboratory results follow the guidelines below Before the Lab Test Perform a control solution test to make sure that the meter is wo...

Страница 16: ...3 3 mmol L 5 Power source DC3 0V CR1620 6 Storage condition Test Strips 39 2 F 86 F 4 C 30 C Humidity 10 80 RH 7 Storage condition The meter 4 F 131 F 20 C 55 C Humidity 10 80 RH 8 Operating conditions 50 F 95 F 10 C 35 C 9 Blood source Fresh capillary whole blood 10 Blood Sample Size Min 0 7 microliter 11 Product life span Five years 12 The table of substances below shows the highest concentratio...

Страница 17: ...r 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 These substances do not affect test results in normal concentrations but may affect test results in high concentrations Do not use haemolysis samples icterus samples or high lipemia samples Patients underg...

Страница 18: ...n the test strip 2 Test strip or control solution has expired 3 Test strip has been damaged due to heat or humidity 1 Retest with a new test strip and make sure that enough sample has been applied 2 Retest with a new test strip or new control solution 3 Perform a control solution test using a new test strip If results are still out of range replace with new vial of test strips 4 iHealth System is ...

Страница 19: ...of a defect to the extent permitted by law these are the sole and exclusive remedies For more information please visit www ihealthlabs com or contact customer service Manufactured for iHealth Lab Inc USA iHealth Lab Inc www ihealthlabs com Mountain View CA 94043 USA 1 855 816 7705 8 30 AM 5 30 PM PST Monday to Friday except holidays Email support ihealthlabs com Europe iHealthLabs Europe SARL www ...

Страница 20: ... should not be disposed of with household waste Please recycle where facilities exist Check with your local authority or retailer for recycling advice THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES Keep away from rain Lot Number Use by date Sterilized Using Irradiation Complies with IVD98 79 EC requirements 18 Do not Reuse Authorized representative in the European Community ...

Страница 21: ...armful 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...

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