iHealth BG1 Align Gluco-Monitoring System User Manual

iHealth BG1 Align Gluco-Monitoring System User Manual

WELCOME

Welcome to your iHealth Align Gluco-Monitoring System (the iHealth system). The iHealth system is designed to be used with the free iHealth Gluco-Smart App (the App) and will help you manage your diabetes.

COMPATIBILITY

The iHealth system is compatible with select iOS and Android devices. For a complete list of compatible devices, visit our support page on www.ihealthlabs.com.

INSTALL THE BATTERY

Your meter comes with two 3V CR1620 lithium battery. The battery lasts up to six months depending on the usage. Follow the instructions below to replace the battery.

1. Turn the meter over with the iHealth logo facing down.
2. Lift off the back cover by pulling firmly from the notch next to the test strip port.
3. Insert the new battery with the “+” side facing up and snap it into the battery tray.
4. Press the back panel back in place by inserting the front clip into place and snapping the back of the cover down.

When the “Battery is low” indicator appears on the app, replace the battery to ensure successful and accurate measurements.

Disposal – Electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.

GET STARTED

Download the App

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

Access the iHealth Cloud Account

Your iHealth account also gives you access to the free and secure iHealth cloud service. Go to www.ihealthlabs.com and click “Sign In” for access once your account has been created.

Scan to Code the Test Strips

Please carefully read and follow the instructions below to avoid getting inaccurate test results and/or test strip tracking errors:
Connect your mobile device to the Internet and open the Gluco-Smart App. When prompted, scan the QR code on the top of the iHealth test strip vial to calibrate the test strips with the meter. You must scan the QR code each time a new vial is opened.

Test blood glucose level

Step 1: Launch the App
Step 2: Connect the meter
– Plug your meter into the headphone jack of your mobile device. The iHealth logo on the meter should be facing the same direction as the screen of your mobile device.

Note :

• Do not twist your meter during the measurement process.
• Remove the case on your mobile device before connecting the meter.

Step 3: Insert the test strip into the meter’s strip port

Make sure the red arrow marker on the test strip is facing the same direction as the iHealth logo on the meter.

Step 4: Prepare the lancing device

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

Step 5: Obtain a blood sample

Press the lancing device against the site to be lanced and then press the release button to puncture the site. Gently squeeze the site until a drop of blood forms.

Step 6: Apply the blood sample to the test strip

Quickly apply the blood sample to the absorbent hole on the tip of the test strip. Make sure the confirmation window of the test strip is completely filled with the blood sample, and remove your finger

Step 7: Read the test results

After approximately 5 seconds, your blood glucose result will appear on your mobile device screen. The meter needs to remain connected to your mobile device during testing and syncing.

Step 8: Discard the used test strip and lancet

Remove the used test strip from the meter using a tissue.

Remove the lancet from the lancing device. (Tip: Prior to disposal, stick the lancet into the cover that was snapped off earlier in the process.)
Discard the used test strip and lancet properly.

Note :
Refer to the Cleaning and Disinfecting section of the Owner’s Manual for cleaning and disinfecting procedures.

PRODUCT SUPPORT

For more product information, please go to Settings > Help with the app or visit us online at
www.ihealthlabs.com

CUSTOMER SERVICE

If you need additional iHealth test strips, iHealth control solution, lancing devices, or lancets, please contact:

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. CET, Monday to Friday, except holidays)
Email: support@ihealthlabs.eu
For additional product information, please go to www.ihealthlabs.com.

IMPORTANT SAFETY INSTRUCTIONS:

ONLY use iHealth test strips. The meter and lancing device are for single patient use only. Do not share them with anyone, including other family members.
Please refer to the iHealth Align Gluco-Monitoring System Owner’s Manual for more information.

iHealth is a trademark of iHealth Lab Inc.

©2013 iHealth Lab Inc. All rights reserved.
Manufactured for iHealth Lab Inc., Mountain View, CA 94043, USA.

Device Compatibility

Apple iOS devices (requires iOS version 8.0 or higher)

SUPPORT iPhone 8/8 Plus, iPhone X, iPhone XR, iPhone XS, and iPhone XS MAX by using the original Apple Lighting to 3.5 mm Headphone Jack Adapter

• iPhone 7/7 Plus

• iPhone 6S/6S Plus

• iPhone 6/6 Plus

• iPhone 5S/5C

• iPhone 5

• iPhone 4S

• IPod Touch 6th Gen

• iPod Touch 5th Gen

FAQ

Test Strips and Coding:

__What kind of test strips should be used with the iHealth Align?

Only use iHealth brand test strips with the iHealth system.

__Why can’t I scan the QR code, and why does the error “Make sure your

meter and mobile device are connected when scanning the QR code” pop up every time?

Before we can see if there is an issue with the app, we need to make sure the iHealth Align is making a connection and is fully powered.

When plugging in the iHealth Align, you will see that the Align symbol on the app (upper left) will turn blue to show that the connection is activated. If this does not happen, it could be one of 2 issues:

1. The Align is not fully plugged in, or could be blocked by your phone case
2. The battery in the Align is dead or not fully charged

You may click on the How-To video link below to verify that everything is being done correctly.

https://www.youtube.com/watch?v=jXWrmtncAQ

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.

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:

__Blood Glucose Levels: How long does it take to check?

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

__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 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.

Product Information:

__How do I conserve battery life?

Please remove the test strip and meter from your mobile device after each reading to conserve battery life

__Will this product come with a battery?

iHealth Align comes with two CR1620 batteries. Install the battery before use. Please refer to the Quick Start Guide for installation

__Will the app alert me when the battery is low?

Yes. Make sure to replace the battery immediately when you see the low battery message to ensure uninterrupted use.

__Will iHealth Align work with a phone case on?

This will depend on the phone case that you have. You can use it with a phone case as long as iHealth Align is fully inserted into the audio port.

__Can iHealth Align take offline readings?

No, iHealth Align must be plugged into a smart phone, and used with the companion iHealth Gluco-Smart app in order to take a reading.

__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.

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