Related Manuals for iHealth BG5S
Summary of Contents for iHealth BG5S
- Page 1 Wireless Smart Gluco-Monitoring System Model: BG5S OWNER'S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing...
-
Page 2: Table Of Contents
COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS ..18 Before the Lab Test ......................... 18 While at the Lab ........................18 THE iHealth Wireless Smart Gluco-Monitoring System SPECIFICATIONS ....... 18 MAINTENANCE AND STORAGE OF YOUR METER............19 SYSTEM TROUBLESHOOTING ....................19 Display Messages ........................ -
Page 3: Introduction
(sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth Wireless Smart Gluco-Monitoring System (BG5S) is intended to be used by a single person and should not be shared. -
Page 4: Limitations Of Use
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 iHealth system on soft surfaces that may block the test port. Keep test port free from lint, hair, debris, etc. - Page 5 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.
-
Page 6: Contents Of The Wireless Smart Gluco-Monitoring System
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. - Page 7 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. •...
-
Page 8: Parts And Displays
(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. 6 / 27... -
Page 9: Mobile Device Compatibility
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... -
Page 10: 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. - Page 11 • PROCESS 2 Login in your app Create an iHealth ID first, and then you can login your app. Note2: You can create an iHealth ID by following instructions in your app, or go to www.ihealthlabs.com create.
- Page 12 • 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 Snap off the lancet device cap ② Insert a new lancet firmly into the lancing holder cup ③...
- Page 13 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.
- Page 14 Ⅴ Ⅴ Ⅴ Ⅴ • PROCESS Test blood glucose level Ⅴ Ⅴ Ⅴ Ⅴ Step -1: Scan the QR code on the top of the iHealth test strip vial to calibrate the test strips with the meter. 12 / 27...
-
Page 15: Data Syncing
-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. Ⅴ Ⅴ Ⅴ Ⅴ... -
Page 16: Signs Of Potential Physical And Performance Deterioration
Alternative site testing (AST) is the use of parts of the body, other than the fingertips, to check blood glucose levels. The iHealth Wireless Smart Gluco-Monitoring System 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: What Is The Advantage Of Alternative Site Testing
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. What Is the Advantage of Alternative Site Testing? Pain is felt more readily on the fingertips because they are full of nerve endings (receptors). -
Page 18: Important Information About Control Solution Tests
Materials needed to perform a control solution test: iHealth Wireless Smart Glucose Meter (BG5S) iHealth Test Strips (AGS-1000I / EGS-2003) iHealth Control Solution (Level I, Level II, or Level III) Perform a control solution test when: First receiving or purchasing the meter... -
Page 19: Out-Of-Range Results
• Meter malfunction If you continue to get control solution test results that fall outside of the range printed on the vial, the meter may not be working properly. Discontinue use and call iHealth Labs Customer Service at 1-855-816-7705 for assistance. -
Page 20: 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. The iHealth System results can be affected by factors and conditions that do not affect laboratory results in the same way. -
Page 21: Maintenance And Storage Of Your Meter
If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call iHealth Labs Customer Service at 1-855-816-7705. Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances. - Page 22 Charge the battery. low on power. Re-test with a new test strip. If the problem persists, call Problem with the meter. iHealth Labs Customer Service at 1-855-816-7705 for assistance. Problems have occurred that are related to test strip use, such as:...
-
Page 23: Troubleshooting
Follow the instructions Your meter is not synced to above in the “FIRST TIME the app on your mobile SETUP INSTRUCTIONS” to device yet. sync your meter. The remaining test strip in Scan a new vial of test strips. the vial is “0”. The test strip has expired. -
Page 24: Warranty Information
("Warranty Period"). Under this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the 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 25: Explanation Of Symbols
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. -
Page 26: Important Information Required By The Fcc
(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. NOTE: This product has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. - Page 27 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.
-
Page 28: Electromagnetic Compatibility Information
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. - Page 29 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.
- Page 30 RF communications equipment and the BG5S The BG5S is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BG5S can help prevent electromagnetic interference by...