Summary of Contents for iHealth BG1S
- Page 1 Wireless Smart Gluco-Monitoring System（BG1S） OWNER’S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing...
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Page 2: Table Of Contents
INTRODUCTION IMPORTANT SAFETY INFORMATION Intended use Limitations of use Important safety instructions YOUR NEW WIRELESS SMART GLUCOSE METER Contents of the iHealth Wireless Smart Gluco-Monitoring System (BG1S) Mobile device compatibility TEST PRINCIPLE CONTROL SOLUTION TESTS Warning and precautions Test procedures... -
Page 3: Introduction
The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! The iHealth system is not intended for use on neonates, nor for screening or diagnosis. -
Page 4: Important Safety Instructions
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 test port free from lint, hair, debris, etc. -
Page 5: Your New Wireless Smart Glucose Meter
Package contents vary from country to country. Please refer to the package contents listed on the package you purchased. Note: If any item s printed on the package are missing from your package or the package appears to have been opened prior to y our use, please contact iHealth Customer Care. - Page 6 Wireless Smart Gluco-Monitoring System: The meter: iHealth Test Strips Use iHealth test strips EGS-2003. Do not use the test strips if expired. To keep your test strips in the best possible condition, read the following recommendations thoroughly: Write the expiry date on the test strips vial when first opening. The expiration date can be found at the bottom of the box in which the vial was received in.
- Page 7 Lancing Device Use only with the iHealth lancet. Use only iHealth Control Solution. Keep the control solution at a temperature between 2°C and 30°C (36°F - 86°F) and at a humidity rate of 10 to 85%.
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Page 8: Mobile Device Compatibility
Testing with the iHealth system 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. -
Page 9: Test Procedures
Do not use the control solution after the expiry date or after the shelf-life after opening, whichever comes first, at the risk of getting erroneous results. Test procedures Follow these instructions and refer to the iHealth Wireless Smart Gluco-Monitoring System (BG1S) Owner's Manual for further information. Step 1 Follow instructions on App’s user guide to operate the iHealth App... -
Page 10: Important
Important If test results with the control solution continue to fall outside the range of values printed on the iHealth Test Strips vial, do not use the meter, test strips, or control solution and contact iHealth Customer Care. BLOOD GLUCOSE TEST... -
Page 11: First Time Setup Instructions
Test Strips (EGS-2003) iHealth Lancing device with a lancet loaded iHealth clear cap for alternate site testing (in case of you perform on an AST) The iHealth Wireless Smart Glucose Meter can be used for online test only. About the online test You need the app launched to perform a blood glucose test. - Page 12 You m ust replace the battery according to following instructions before using it again. 1. Turn the meter over with the iHealth logo facing down. 2. Insert the narrow end of the pry plate into the machine groove (close to the iHealth Logo), and press the inner surface of the groove.
- Page 13 Bluetooth is turned on, and BG1S is nearby. Step 4 d. Follow app instructions to insert test strip. Take a new test strip from the test strip vial, hold the middle of the test strip, with the arrow facing the meter, and insert the test strip into the meter’s strip port.
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Page 14: Cleaning And Disinfection
Quickly apply the blood sample to the absorbent hole of the test strip. Make sure the confirmation window of the test strip is completely filled with the blood sample. Do not let blood sample sit for too long before applying to the test strip. Remove your finger from the test strip when APP indicating the beginning of blood sample analysis. - Page 15 Disinfection is to wipe the whole surface of the meter with a gentle disinfecting solution for 2 min, and keep the surface wet during the 2min. The iHealth Wireless Smart Glucose Meter and the iHealth lancing device should be cleaned and disinfected at a minimum of once per week.
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Page 16: Information About Alternate Site Testing (Ast)
INFORMATION ABOUT ALTERNATE SITE TESTING (AST) What is Alternate Site Testing? Alternate Site Testing (AST) is the use of parts of the body, other than the fingertips, to check blood glucose levels. The meter allows you to test on the palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing when used at appropriate times. -
Page 17: Maintenance And Troubleshooting
System troubleshooting If you follow the recommended action below but the problem persists, or error messages other than the ones below appear, please contact iHealth Labs Customer Service. Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances. -
Page 18: Signs Of Potential Physical And Performance Deterioration
If deterioration is observed, please stop using and contact local customer services or place of purchase for assistance, or toll free service hotline: 1-855-816-7705. iHealth WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS Technical specifications 1. Model: BG1S 2. -
Page 19: Important Information Required By The Fcc
(2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by iHealth Labs Inc. would void the user’s authority to operate the product. NOTE: This product has been tested and found to com ply with the limits for a C lass B digital device, pursuant to Part 15 of the FCC Rules. -
Page 20: Electromagnetic Compatibility Information
RED direct i ve. Hereby, Andon Health Co., Ltd. declares that the BG1S is in co mpliance with the Radio Equipment Directive (RED) 2014/53/EU. The full text of the EU declar ation of conformity is available a t the following internet address: www.iHealthlabs.eu... -
Page 21: Warranty Information
Warranty Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1) repair the Product using new or refurbished replacement parts or (2) exchange the Product with a new or refurbished Product. - Page 22 If you have questions or need assistance outside the operational hours and days, please contact your healthcare provider. E-mail : support@iHealthlabs.com Europe: iHealthLabs Europe SAS 36 rue de Ponthieu, 75008, Paris, France www.iHealthlabs.eu Customer service: https://helpcenter.ihealthlabs.eu/hc/en-gb/requests/new or menu Contact in App If you have questions or need assistance outside the operational hours and days, please contact your healthcare provider.
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Page 23: Explanation Of Symbols
EXPLANATION OF SYMBOLS Manufacturer European Authorized Representative In vitro diagnostic medical device Serial number Consult instructions for use Do not use if the package damaged Batch code Catalogue number Caution Use by date Storage temperature Limit Keep away from direct sunlight or near heat sources Keep in a dry place Do not reuse Sterilized using irradiation...