iHealth BG5 Wireless Smart-Gluco Monitoring System User Manual

iHealth BG5 Wireless Smart-Gluco Monitoring System

QUICK START GUIDE

Welcome to your iHealth Wireless Smart Gluco-Monitoring System (the iHealth system). Designed to be used with the free iHealth Gluco-Smart App (the app), the system will help you manage your diabetes in an easy and convenient way.

Contents of the Wireless Smart Gluco-Monitoring System
These contents may vary by region. Please refer to the package contents listed on the package you purchased.

iHealth control solution and iHealth test strips sold separately.

FIRST TIME SETUP INSTRUCTIONS

Prior to first use, download and install the free iHealth Gluco-Smart App from the Apple App Store or Google Play Store. Follow the on-screen instructions to create your iHealth account.

Access iHealth Cloud

You can use your iHealth ID to gain access to free and secure Cloud Services. Go to www.ihealthlabs.com and click on “Sign In”.

Charge the battery

Out of the box
Your meter is powered by a built-in, rechargeable battery. Plug one end of the charging cable into the side of the meter and the other end into your computer’s USB port. Charge it for two to four hours before first use. A fully charged battery can typically take up to 200 tests depending on your daily usage.

Low battery message

After you have used your meter for some time, appears for three seconds when the battery in your meter is low on power. You must recharge the battery before using it again. After three seconds, the meter shuts off automatically. The meter does not take any measurement when the battery is low.

Important : If battery is completely drained, fully charge the battery and launch the app to sync the meter before using it again.

Sync the meter

Prior to first use, follow the steps below to connect the meter to the app on your mobile device to set your meter’s time and date.

1. Enable Bluetooth on your iOS or Android device.

2. Press and hold the “Memory” button for three seconds to turn the meter on.

3. Select the model name “BG5xxxxxx” in the Bluetooth menu to pair and connect.

4. Launch the app to connect the meter to the app. The Bluetooth symbol ” “will flash and remain lit on the meter.

Note : Repeat steps 1-4 when switching to a different iOS or Androiddevice, making sure to un-pair or forget the meter on the previous device.

Scan the test strip vial

Caution : Please carefully read and follow the instructions below to avoid getting inaccurate test results and/or test strips tracking errors.

Connect your mobile device to the Internet and open the Gluco-Smart App. When the glucose meter is connected to the mobile device, scan the QR code on the top of the iHealth test strip vial to calibrate the test strips wit the meter. You must scan the QR code each time a new vial is opened.

When all 25 strips in a vial have been used, appears on the meter to alert you that it is time to open a new vial, and the meter will shut off automatically. The meter does not take any measurement when “Er d” appears on the meter.

Test blood glucose level

If you have synced your meter to the app on your mobile device, scanned the QR code of a test strip vial, and want to take a reading with the app:
[1] Make sure Bluetooth is turned on to connect the meter to the app on your mobile device.
If you have synced your meter to the app on your mobile device, scanned the QR code of test strip vial, and want to take a reading without the app launched: Skip step [1].
[2] Insert the test strip into the meter’s strip port.
Insert the test strip into the strip port with the contact bars facing toward you.

[3] Prepare the lancing device.

① Snap off the lancet device cap
② Insert a new lancet firmly into the lancing holder cup
③ Twist the lancet cover off
④ Replace the lancing device cap
⑤ Set the lancing level
⑥ Cock the handle until it clicks

[4] Obtain a blood sample.

Press the lancing device against the site to be lanced. Press the release button to puncture the site. Gently squeeze your finger until a drop of blood forms. Wipe away the first blood drop and squeeze until a second small blood drops forms.

[5] Apply the blood sample to the test strip.

Quickly apply the blood sample to the absorbent hole (tip) of the test strip. Make sure the confirmation window of the test strip is completely filled with the blood sample.

Quickly remove your finger from the test strip when the countdown (from 5 to

1. begins on the meter display, or when you hear a sound alert from your mobile device.

[6] Read the test results.
-If the meter is not connected to the app, the test result will appear on the meter after counting down from 5 to 1.

– If the meter is connected to the app, the test result will appear on the app.

[7] Discard the used test strip and lancet.

Remove the used test strip from the meter using a small amount of tissue paper. Discard the used test strip and lancet properly. (Tip: Prior to disposal, stick the lancet into the cover)

DATA SYNCING

The meter can save up to 500 of the most recent blood glucose test results. When the meter needs to save a new test result and has already stored 500 test results, the oldest test result will be overwritten by the new test result.
When the meter is connected to the app on your mobile device, tap the “Upload” button to upload the saved data from the meter to the app.

CUSTOMER SERVICE

If you need additional iHealth test strips, iHealth control solution, lancing devices, and lancets, please visit
www.ihealthlabs.com, or you may contact customer service at:

USA:
Tel:+ 1-855-816-7705 (8:30 A.M. – 5:30 P.M. PST, Monday to Friday
except holidays)
Email: support@ihealthlabs.com
Europe:
Tel: +33(0)1 44 94 04 81 (9:00 A.M. – 5:30 P.M., Monday to Friday except holidays)
Email: support@ihealthlabs.eu
For additional product information, please go to
www.ihealthlabs.com
IMPORTANT SAFETY INSTRUCTIONS: Use only iHealth test strips.
The meter and lancing device are for single patient use only.
Don’t share them with anyone, including other family members.
Please refer to the iHealth Wireless Smart Gluco-Monitoring
System Owner’s Manual for more information.
iHealth is a trademark of iHealth Labs Inc.
©2016 iHealth Labs Inc. All rights reserved.
Manufactured for iHealth Labs Inc., Mountain View, CA 94043, USA.

Device Compatibility

Apple iOS devices (requires iOS version 8.0 or higher)

• iPhone 7/7 Plus
• iPhone 6S/6S Plus
• iPhone 6/6 Plus
• iPhone 5S/5C
• iPhone 5
• iPhone 4S
• iPad Air 2
• iPad Air
• iPad Mini 3
• iPad Mini 2
• iPad Mini
• iPad Pro
• iPad 4th Gen
• iPad 3rd Gen
• iPad 2
• IPod Touch 6th Gen
• iPod Touch 5th Gen

Android devices (requires operating system 4.0 or later)

• Samsung Galaxy S7/S7 Edge

• Samsung Galaxy S6/S6 Edge

• Samsung Galaxy S5

• Samsung Galaxy S4

• Samsung Galaxy S3

• Samsung Galaxy Note3

• Samsung Galaxy Note2

• HTC One M7

• LG Nexus 4

• LG Nexus 5

• Motorola Nexus 6

FAQ

Troubleshooting

The meter countdown did not start

The test strip may not be inserted correctly. Re-test using a new test strip.

Test results are inconsistent or control solution test results are not

within the specified range

Re-test with a new test strip and make sure there is at least 0.7 micro liter of blood sample or control solution on the strip. If the results are still out of range, contact Customer Service at 1-855-816-7705.

The meter displays “ErF”

Measurement cannot be taken while the meter is charging. Unplug the charging cable before testing.

The meter displays “ErE”

The test strips have expired. Use a new test strip.

The meter displays “Lo”

Battery level is low and needs to be charged before use.

The meter displays “Er3”

Re-test with a new test strip. If the problem persists, call Customer Service at 1-855-816-7705.

The meter displays “Er2” or “Er4”

Re-test with a new test strip. If the problem persists, call Customer Service at 1-855-816-7705.

The meter displays “Er8”

There is a communication error. Re-pair to your mobile device and try taking the test again.

The meter displays “Er6”

The environmental temperature is high. The operating temperature needs to be 50°F～104°F (10°C～40°C).

The meter displays “Er5”

The environmental temperature is low. The operating temperature needs to be 50°F～104°F (10°C～40°C).

The meter displays “Erd”

There are no more remaining strips in the vial. Scan a new vial of test strips.

The meter displays “ErC”

Your meter is not synced to the app on your mobile device. Follow the instructions for first time set up to sync your meter.

The meter displays “Er9”

The test strip was removed during measurement. Retest using a new test strip.

Setup and Usage

Are test results lost when the battery dies?

No, the meter will save your measurements even when the battery is completely drained.

Can I set up the app so multiple users can use the iHealth Wireless

Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is designed for single user only. It is not recommended to share your device with anyone, including other family members.

What do I do if the battery is completely drained?

The battery will drain completely if you forget to charge it as recommended or if your meter is not used for a lengthy period of time. When this happens, recharge the battery and launch the App to sync the meter with your mobile device before using the meter again.

How many measurements can be taken on a full battery charge?

Up to 200 measurements can be taken on a full battery charge.

How long do I need to charge the battery before first use?

You need to charge the battery for 2-4 hours before first use.

How can I configure the time and date on the meter?

Prior to first use you need to sync the meter to the app on your mobile device to set your meter’s time and date. Refer to the Quick Start Guide for more information.

How do I switch between multiple mobile devices?

Turn off the Bluetooth of the last used mobile device if the two mobile devices are within 66 feet, then follow the instructions in the Quick Start Guide to pair with the iHealth meter. Keep in mind that you will have to re- pair each time you switch mobile devices.

Can this be used with more than one mobile device?

Yes, you can use the iHealth Wireless Smart Gluco-Monitoring System with as many mobile devices as you wish. Just install the iHealth Gluco-Smart App on each device you intend to use with the meter.

Test Strips and Coding

How do I get control solution?

Control solution can be purchased in our online store at www.ihealthlabs.com.

Do I need to scan the QR code every time I insert a new test strip?

No. You only need to scan QR code when you open a new vial of test strips.

What is the QR code on the test strip vial? Why do I need to scan the QR

code?

The QR code is located on the top of iHealth test strip vial. You must scan the QR code before using it for the first time and any time you open a new vial of test strips. The QR code scanning feature provides you with a convenient way to code the meter with the test strips to ensure accurate blood glucose results. Scanning the QR code also enables the app to track and show you the quantity of test strips in the vial, as well as expiration information.

What happens if I use expired test strip?

An error message will appear on the app to remind you to use a new test strip or an error code will display on the meter if you are doing an offline test.

What kind of test strips should be used with the iHealth Gluco-smart

Monitoring System?

Only use iHealth brand test strips with the iHealth system.

Which way does the test strip go into the meter?

Make sure you insert the test strip with the contact bars facing up into the test strip port.

What should I store the iHealth test strips in?

Store your iHealth test strips in their original vial only. Never store them in another vial, any other container or outside the vial.

Can I re-use the test strip?

No, you should only use a test strip once.

What are the tips for proper handling and storage of the iHealth test

strips?

Shake a test strip out into your hand. Try not to touch the end of the strip. Wash and dry your hands thoroughly before you open the test strip vial. Use the test strip immediately after you remove it from the vial. Don’t expose test strips to direct sunlight or extreme heat. Don’t freeze test strips or store them in extreme cold. Immediately close the vial after you open it. Store test strips in their original vial with the lid securely closed. Do note transfer test strips between vials.Keep test strips in a dry place and follow the recommended storage conditions as specified in the user’s manual: Storage condition: 39.2° F ~ 86° F (4° C ~ 30° C), Humidity 10% ~ 80% RH.

My test strip expiration is at a later date. Why does the app say my

test strips are expired?

Once the test strips are opened and scanned for the first time, a countdown of 90 days begins. This is to prevent any inaccuracies due to the test strips being exposed to moisture, light, etc.

Checking Blood Glucose

__What conditions are not suitable for using the iHealth system?

Please refer to the “Limitations of Use” section in the owner’s manual.

__Why the test result is different from using other brand glucose

meter?

The iHealth system provides you with the whole blood equivalent results. The result you obtain may differ somewhat from other home use glucose meters result due to normal variation. You can take a control solution test if you suspect the test results are not accurate. Refer to the “Performing a Control Solution Test” section on owner’s manual.

__How can I use the Clear Cap for AST?

The clear cap is for palm, forearm, upper arm, calf, or thigh sampling only. Replace the lancing device cap with the Clear Cap when doing an AST test.

__Can I use a blood sample from other areas of my body?

Yes. Alternate Site Testing (AST) is the use of parts of the body, other than the fingertips, to check blood glucose levels. The iHealth 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. There are limitations for doing AST. Please consult your healthcare professional before you conduct AST. The iHealth system should only be used for AST under steady- state blood glucose conditions. Refer to the  “Information about Alternate Site Testing (AST)” section on owner’s manual for detailed information.

__What is a control solution test and how do I run a control solution

test?

The control solution test using iHealth control solution ensures that you are performing tests correctly and receiving accurate results. Refer to the “Important Information About Control Solution Tests” section on the owner’s manual for detailed instructions.

__How do I use the lancing device?

Prepare the lancing device first by following the steps below and press the lancing device against the site to be lanced.

Press the release button to puncture the site.

1. Snap off the lancet device cap
2. Insert a new lancet firmly into the lancing holder cup
3. Twist the lancet cover off
4. Replace the lancing device cap
5. Set the lancing level
6. Cock the handle until it clicks

__When or how often should a control solution test be performed?

Control solution tests should be performed when:

1. First receiving or purchasing the meter.
2. Checking the meter and test strips (which should be done at least once a week).
3. Using a new vial of test strips.
4. You suspect the meter or test strips are not working properly.
5. Your blood glucose test results are not consistent with your expectation, or you think the results are not accurate.
6. Practicing the testing process.
7. The meter has been dropped or damaged.

__How do I easily get a drop of blood?

There are a few ways you can improve blood flow and make blood glucose checks easier:

1. Warm your fingers by washing with warm, soapy water, then rinse and dry completely.
2. Let your arm hang down at your side to increase blood flow to the fingertips.
3. Grasp finger just below the joint closest to the fingertip and massage gently toward tip of finger, then squeeze for 3 seconds.
4. Set the iHealth lancing device at the appropriate level for you.

__How much/large of a blood sample is needed?

Minimum of 0.7 micro liter is required.

__How long does the iHealth system to take check blood glucose level?

Once the blood sample is on the test strip, it takes about five seconds to get your reading.

__How do I know that enough blood sample has been taken?

Make sure the confirmation window of the test strip is completely filled with the blood sample. Remove your finger quickly when countdown appears in the meter display or when you hear a sound alert from the app if the meter is connected to a mobile device.

__How do I see my test results on meter?

Press the memory button located in the side of the meter to view the test results stored in the meter. The first reading you’ll see is your most recent blood glucose result. To review earlier test results, press the memory button repeatedly.

Product Information

__What is the iHealth Wireless Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is the innovative blood glucose monitoring system that connects with your mobile device through Bluetooth technology to help you test, track and manage your Blood Glucose levels. The iHealth system works with the free iHealth Gluco-Smart App that has personalized health tools to help you get the most out of your data and to better manage your health goal. Through the app, you can easily view glucose trends over time, set test and medication reminders, track test strip quantity and expiration information and share data with your healthcare provider.

__How accurate is the iHealth Wireless Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is a FDA and CE approved device. It meets the rigorous accuracy standards set by the governing bodies in the USA and Europe. It meets the ISO 15197:2013 requirements, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.nnThe standard requires that manufacturers of these systems provide even greater accuracy than the previous version. For detailed information, please visit http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1749.

__Can measurements be taken without a mobile device?

Yes. After the meter is synced with your mobile device, you may use the meter when your mobile device is not available. The measurement data will be stored in the meter.

__How many offline measurements can be stored in the meter?

Up to 500 offline measurements can be stored in the meter.

__Can I use other brand test strips on the iHealth meter?

No, only iHealth brand test strips can be used for the meter.

__Can I use other brand lancets?

You should try to use iHealth brand lancets. Some generic lancets might be compatible, consult with pharmacist before you purchase non-iHealth brand lancets.

__Can I set up the app so multiple users can use the iHealth Wireless

Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is designed for single user only. It is not recommended to share your device with anyone, including other family members.

__Is the iHealth meter covered by insurance?

No, it is not covered by insurance, we are working with insurance providers right now to try to get coverage. However, we have priced our test strips very reasonably, making it comparable to most co-pays.

__How do I clean the meter and how often?

The meter and lancing device should be cleaned and disinfected following each use. We suggest that you use CaviWipesTM ((Metrex® Research Corporation, EPA Reg. No. 46781-8, EPA Est. No. 56952-WI-001). Refer to the “Cleaning and Disinfection” section in the owner’s manual for detailed information.

__Can I set up the app so multiple users can use the iHealth Wireless

Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is designed for single user only. It is not recommended to share your device with anyone, including other family members.

__Can I set up the app so multiple users can use the iHealth Wireless

Smart Gluco-Monitoring System?

The iHealth Wireless Smart Gluco-Monitoring System is designed for single user only. It is not recommended to share your device with anyone, including other family members.

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