Introduction; Intended Use; Important Safety Instructions - iHealth BG1 Owner's Manual

INTRODUCTION

Thank you for purchasing the iHealth Align Gluco-Monitoring System (BG1). This manual
provides important information to help you use the system properly. Before using this product,
please read the Owner's Manual thoroughly. Regular monitoring of your blood glucose levels can
help you and your doctor gain better control of your diabetes. Due to the meter's compact size
and simple operation, you can easily self-monitor your blood glucose levels anywhere, anytime.
If you have questions regarding this product, please visit www.ihealthlabs.com, contact your
place of purchase, or call iHealth Labs Customer Service at 1-855-816-7705.

INTENDED USE

The iHealth Align Gluco-Monitoring system (BG1) is intended to be used for:
• Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the
fingertip, palm, forearm, upper arm, calf, or thigh.
• Single person measurement (it should not be shared).
• Self-testing 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 with the iHealth Align
Gluco-Monitoring System to quantitatively measure glucose 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 Align 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 iOS application for the iHealth Gluco-Monitoring System,
and is used for data extraction and analysis.

IMPORTANT SAFETY INSTRUCTIONS

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