iHealth® Wireless Smart Gluco-Monitoring System（BG1S） OWNER’S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing
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 Expected values Important BLOOD GLUCOSE TEST Important information First time setup instructions About the online test CLEANING AND DISINFECTION INFORMATION ABOUT ALTERNATE SIT
INTRODUCTION Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (BG1S). This manual provides important information to help you to use the system properly. Before using this product, please read the Owner’s Manual thoroughly. If you have questions regarding this product, please visit www.iHealthlabs.com, contact your place of purchase, or call iHealth Labs Customer Service at 1-855816-7705 (Mon.-Fri.
i.e. Within 2 hours of eating, exercising or taking medication. If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) this medication might affect the reliability of your blood glucose results (blood concentrations >5 mg/dL). If you are unsure, then ask your healthcare professional. Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease.
All parts of the kit are considered biohazards and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. Remove the batteries if the blood glucose meter will not be used for a month or more to avoid relevant damage of battery leakage.
iHealth 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. Store the test strips vial between 39°F ~ 86°F (4° C to 30° C) and 10% ~ 85% relative humidity.
iHealth 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%.
Do not expose to direct sunlight or place near heat sources. Use before the expiry date mentioned on the vial. Use the control solution within 90 days of initial opening of the vial. Close the vial immediately after each use. To avoid contamination of the control solution, do not apply directly it to the test strip from the bottle. Dispose of used equipment according to regulations applicable in your country. Refer to the Control Solution tests part to know how to use the Control Solution with your meter.
The control solution must be used within 90 days of opening the vial (Shelf-life after opening) 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.
was not wiped. The storage temperature of the control solution (between 2°C and 30°C) has not been observed. iHealth Wireless Smart Gluco-Monitoring System (BG1S) is faulty. 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.
First time setup instructions Warning Blood glucose results should be displayed in mg/dL, please contact Customer Service if your meter is not set to mg/dL when you first turn on the meter. Using the wrong unit of measurement may cause misinterpretation of your actual blood glucose level and may lead to improper therapy. Before you perform your first blood glucose test, perform a control test to ensure the meter and test strips are working correctly together and are not defective.
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. 3. Push against the inner surface of the groove and lift up the machine shell.(parts with iHealth Logo) 4. Insert the battery with the “+” side facing up and snap it into place. 5. Press the back panel back in place. Green LED（on the side with iHealth logo） on the meter will light up for 3sec after installation of battery.
Do not try to pair the device directly to your phone’s Bluetooth. The meter is noconnectable to your mobile device. It can only be paired through the app once the devices is entered in.Refer to the app’s guide to add your meter to the app. STEP 4 Test your blood glucose level Step 4 a. Prepare the lancing device. First read the manual of the lancing device for the instructions on how to prepare the lancing device. Step 4 b. Wash your hands with warm soapy water for 20 seconds and dry thoroughly.
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. The test result will appear on the display within 5s. Step 4-7: Read the test results. The test result will appear on the app.
It can help to prevent infection, the potential spread of infection, and crosscontamination. The cleaning and disinfection is absolutely necessary for the test procedure, because cleaning can ensure the meter works well (for example, the display will be clear to see after cleaning). Disinfection can avoid the infection to you or to the other people, and the crossinfection.
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. Caution: When performing Alternate Site Testing, please remember to change the cap of the lancing device to the clear cap specially designed for AST.
Caution: Alternate Site Testing should not be used to calibrate continuous glucose monitoring systems (CGMs). Results from Alternate Site Testing should not be used in insulin dose calculations.
The meter does not respond, and red LED lights up new vial of Test Strips. 4. Bring the system to a room-temperature environment and wait approximately 30 minutes before performing a new test. System suspend The meter will recover to default state in 10s after system suspend automatically. Please wait until the green LED remains lit for 3sec Battery power is too low repalce the battery for use.
7.Storage condition: Test Strips 39° F～86° F (4° C～30° C), Humidity 10% ~ 85% RH 8.Storage condition: The meter -4°F～131° F (-20°C～55°C); Humidity 10%～ 80%RH 9. Operating conditions: 50°F ~ 104°F (10° C ~ 40° C),Humidity 25%～80%RH 10. Blood source: Fresh capillary whole blood 11. Blood volume: Min. 0.7 microliter 12. Life span: Five years 13.
FCC ID:SLRBG1S IC:10913A-BG1S This product com plies with Industry Canada IC: RSS-210. This produc t is approved in accordance to RED directive. 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.
1845 1970 2450 5240 5500 5785 2400-2570 5100-5800 Pulse modulation 217Hz, 28V/m Pulse modulation 217Hz, 9V/m WARNING: ①Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
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.
EXPLANATION OF SYMBOLS Manufacturer EC REP 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 Bluetooth sign Complies with the requirements of the European IVD Directive (98/79/EC) This device complies with part 15 of the FCC
FCC & IC警语 20200819 吕萌
