Bedienungsanleitung iHealth BG1 (Seite 3 von 24) (Englisch)

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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.

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.

INTENDED USE

IMPORTANT SAFETY INSTRUCTIONS

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

these instructions in a safe place for reference.

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

• The glucose meter and lancing device are for single patient use. Do not use either item on

multiple patients.

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

• Do not place the iHealth system in or near liquid.

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

• Use only iHealth branded accessories.

• 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 glucose meter 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 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 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

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