iHealth® Wireless Smart Gluco-Monitoring System Model: BG5S OWNER'S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing
Table of Contents INTRODUCTION ............................................................................................................................ 1 INTENDED USE ............................................................................................................................. 1 IMPORTANT SAFETY INSTRUCTIONS .................................................................................... 1 LIMITATIONS OF USE ............................................................................
INTRODUCTION Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (the iHealth system). This manual provides important information to help you use the system properly. Before using this product, please read the Owner’s Manual thoroughly.
instructions in a safe place for reference. Misuse of the iHealth system can cause electrocution, burns, fire, and other hazards. The meter and lancing device are for single patient use. Do not use either item on multiple patients. Do not share the meter or lancing device with anyone, including other family members. Do not place the iHealth system in or near liquid. The iHealth system can be used up to an altitude of 3276 meters (10744 feet).
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 undergoing oxygen therapy may yield falsely lower results The glucose meter and lancing device are for single patient use Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis. Not for use on critically ill patients.
CONTENTS OF THE WIRELESS SMART GLUCO-MONITORING SYSTEM Package contents vary from country to country. Please refer to the package contents listed on the package you purchased. 1. iHealth Wireless Smart Glucose Meter (BG5S) 2. iHealth Test Strips * 3. iHealth Lancing Device 4. Lancet* 5. Clear Cap for Alternative Site Testing 6.
. Owner’s Manual 8. Quick Start Guide 9. USB Charging Cable 10. Carry case The contents in package of item * is vary from the sales area. Note: • There are three levels for the control solutions: Level I, Level II and Level III. Please note that only the level II control solution may be included in the your kit. The level I and level III control solution are not included in the your kit. You can call iHealth Labs Customer Service for additional levels.
• iHealth Labs Customer Service hotline: 1-855-816-7705 (8:30AM – 5:30PM PST, Monday to Friday except holidays) Parts and Displays iHealth Wireless Smart Glucose Meter (BG5S) iHealth Test Strips Use only iHealth test strips with the meter. Each test strip can be used only once, and consists of the following parts.
iHealth Lancing Device Mobile Device Compatibility Works with the iOS version 8.0/9.0 devices, for example: iPhone 4S iPhone 5 iPhone 5c iPhone 5s iPhone 6 iPhone 6 Plus iPhone SE iPod Touch 5G iPod Touch 6G iPad 3 iPad 4 iPad Air iPad Mini 2G iPad mini 3G iPad mini 4G iPad Air 2 Works with the Android version 4.2/5.0/6.
Samsung Galaxy Note3 (SM-N9006) Motorola Nexus 6 For a complete list of compatible devices, visit our support on page on www.ihealthlabs.com TEST PRINCIPLE 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.
confirm your test strip type first. And then following the instruction below according the test strip type. Test strip type is EGS-2003. About the first time test. We recommend you finish the first time test through online mode showing below from PROCESS 1 to PROCESS 5. But you can also finish the first time test through offline mode (only following PROCESS 5). About the general time test.
• PROCESS 5 Test blood glucose level Step 5-1: Insert the test strip into the meter’s strip port with the contact bars facing toward you. Step 5-2: Prepare the lancing device. ① ② ③ ④ ⑤ ⑥ Snap off the lancet device cap Insert a new lancet firmly into the lancing holder cup Twist the lancet cover off Replace the lancing device cap Set the lancing level Cock the handle until it clicks Step 5-3: Obtain a blood sample. Press the lancing device against the site to be lanced.
Step 5-5: Read the test results. Case ①：If the meter is connecting with the app, the test result will appear both on the app and your meter. Case ②：If the meter is not connecting with the app, the test result will appear on the meter after counting down from 5 to 1. Note 5-5: The results obtained from the glucose meter are plasma-calibrated. This helps you and your physician or other qualified healthcare providers to compare your meter results with laboratory tests.
Test strip type is AGS-1000I. About the first time test. You must finish the first time test through online mode showing below from PROCESS Ⅰ to PROCESSⅤ. About the general time test. After you have finished the first time test, you can finish test through online mode (following PROCESS 4 and 5). But you can also finish test through offline mode (following step5-2 to step5-7). • PROCESS Ⅰ Download the companion app Same to PRCESS 1 (above). • PROCESS Ⅱ Login in your app Same to PRCESS 2 (above).
NoteⅤ-1: •Please carefully read and follow the App’s instructions on the page of scanning-result. •When you have scanned the QR Code once and you haven’t changed strip’s model, there’s no need to scan for this vial unless you change anther mobile device. •As soon as your vial is changed, must follow StepⅤ-1 which is scanning the QR code on the top of the iHealth test strip vial. •When your mobile device is changed, please re-scan the QR code on the top of the iHealth test strip vial which you are using.
Below are the steps on how to clean the meter and lancing device. (1) After a test, clean and wash your hands. (2) Use one CaviWipe to carefully clean the entire external surface of the meter. (3) Then wipe the entire external surface of the meter with another wipe, and keep the surface wet for 2 minutes. (4) Use the same method with the CaviWipes to clean and disinfect the lancing device. Note: • Wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.
Caution: When performing Alternate Site Testing, please remember to change the cap of the lancing device to the clear cap specially designed for AST. There are limitations for doing AST: • Please consult your healthcare professional before you conduct AST. • The iHealth Wireless Smart Gluco-Monitoring System should only be used for AST under steady-state blood glucose conditions.
Two hours or more after exercising. Caution: Do not use sites other than fingertips for testing when blood glucose is rapidly rising or falling, within 2 hours of eating, after taking insulin, immediately after exercise, or when you are ill or under stress. Alternative Site Testing should not be used to calibrate continuous glucose monitoring systems (CGMs). Results from Alternative Site Testing should not be used in insulin dose calculations. Do not use AST if: • You think your blood glucose is low.
forbidden to perform a control solution test with test strip AGS-1000I. Step A-1: Turn on the control solution test (CTL) mode. Insert the test strip into the meter’s strip port to turn on the meter. When the blood sample symbol appears on the meter display, press the memory button to turn on the CTL mode. When the CTL symbol appears, the meter is in control solution test mode and will not save this test result in memory.
NOTE: • Do not use expired control solution. • The control solution range printed on the test strip vial is for control solution use only. It is not a recommended range for your blood glucose level. COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS The iHealth System provides you with whole blood equivalent results. The result you obtain from your glucose meter may differ somewhat from your laboratory results due to normal variation.
7. Storage condition: Test Strips 39°F～86°F (4°C～30°C), Humidity 10%～85%RH The meter -4°F～131° F (-20°C～55°C); Humidity 10%～80%RH 8. Operating conditions: 50°F～104°F (10°C～40°C) , 25%RH～80%RH 9. Blood source: Fresh capillary whole blood 10. Blood volume: Minimum 0.7 micro liter 11. Life span: Five years 12.
The battery in your meter in low on power. Charge the battery. Problem with the meter. Re-test with a new test strip. If the problem persists, call iHealth Labs Customer Service at 1-855-816-7705 for assistance. Problems have occurred that are related to test strip use, such as: - Test strip may be wet or damaged - Test strip may have been removed too soon - You applied more blood Re-test using a new test strip.
Your meter is not synced to the app on your mobile device yet. Follow the instructions above in the “FIRST TIME SETUP INSTRUCTIONS” to sync your meter. The remaining test strip in the vial is “0”. Scan a new vial of test strips. The test strip has expired. Use a new test strip. Troubleshooting Problems 1. 2. Display remains blank after the test strip has been inserted into the meter. 3. 1. Possible Causes Battery power is too low for use.
The meter countdown did not start. Test strip has not been inserted correctly. Use a new test strip and redo the test. WARRANTY INFORMATION iHealth Labs, Inc. ("IHealth") warrants the iHealth meter (the "Product"), and only the Product, against defects in materials and workmanship under normal use for a period of three years from the date of purchase by the original purchaser ("Warranty Period").
EXPLANATION OF SYMBOLS In vitro diagnostic medical device Serial number Caution , consult accompanying documents Consult instructions for use Manufacturer Environmental Protection–Electrical products waste should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice. Authorised representative in the European Community Catalog number Storage temperature limit This device complies with part 15 of the FCC rules.
Do not Re-use Complies with IVD98/79/EC requirements IMPORTANT INFORMATION REQUIRED BY THE FCC This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (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.
IC NOTICE This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radioexempts de licence.
This product is approved in accordance to RED directive. ELECTROMAGNETIC COMPATIBILITY INFORMATION Table 1 For All ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration - electromagnetic emissions The BG5S is intended for use in the electromagnetic environment specified below. The customer or the user of the BG5S should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The BG5S uses RF energy only for its internal function.
Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration - electromagnetic immunity The BG5S is intended for use in the electromagnetic environment specified below. The customer or the user of the BG5S should assure that it is used in such an environment.
Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the BG5S The BG5S is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
