User Manual for the iHealth Gluco+

The iHealth Gluco+ is an FDA approved smart, wireless blood glucose-monitoring system. It is a portable and accurate diabetes management device designed for personal use. For more information about the iHealth Gluco+ Blood Glucose Monitor, read the blog here!

The operation manual below was extracted from iHealth Labs Support

Get to know the iHealth Gluco+ Intended Use

The iHealth Wireless Smart Gluco-Monitoring System consists of the iHealth Wireless Smart Glucose Meter, iHealth Test Strips and the iHealth Gluco-Smart App mobile application.

The iHealth Gluco+ system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The system is intended to be used by a single person and should not be shared. It is designed for self testing outside the body by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The iHealth Wireless Smart Gluco-Monitoring System should not be used for the diagnosis or of self screening of diabetes or for neonatal use. Alternative site testing (AST) should be done only during steady-state times (when glucose is not changing rapidly).

iHealth Gluco+ Mobile Device Compatibility

The Gluco+ system is compatible with:

• Apple iOS devices (requires iOS version 8.0 or higher)
• Android devices (requires operating system 4.0 or later)

The iHealth Gluco+ Parts

The iHealth Gluco+ Kit includes:

1 x Smart Glucose Meter

1 x Lancing Device

1 x Test Strip

1 x Lancet

1 x Control Solution

1 x Clear Cap for AST

1 x USB Charging Cable

1 x Travel Case

The iHealth Gluco+ Smart Meter Features and Display Symbols

LED Display

Test results, symbols and messages appear here.

Strip Port

Insert the test strip into the strip port to automatically turn on the meter.

Micro USB

Charge the meter through the provided USB cable.

Memory Button

Located on the side of the meter. It is used to turn on the meter and view past test results.

Eject button

Located at the back side of the meter. It is used to automatically remove the test strip.

Blood Sample Symbol

Flashes when the meter is ready to accept the blood sample.

Bluetooth Symbol

Appears when the meter is connected with an iOS device through the Bluetooth function.

CTL Symbol

Appears when doing a control solution test and indicates that the result won’t be stored in the memory.

Test Result Display

Displays the test result.

Low Battery Symbol

Appears when the battery is low.

Measurement Unit

Appears with the test result either in mg/dL or mmo/L.

Setting up the iHealth Gluco-Smart App and Gluco+ Meter

The iHealth Gluco-Smart App can be downloaded for free from the Apple App Store and Google Play Store. Then:

1. Open the app and follow the on screen instructions to create your iHealth ID.
2. Turn on your mobile device's Bluetooth.
3. Connect the Gluco+ meter to the app by clicking on “My Devices” in the app’s menu.
4. On the “My Devices” screen, click the ‘+’ icon in the top right hand corner to add a new device.
5. In the “Add Device” screen, select “Gluco+” as the meter. Make sure the Bluetooth is turned on and the meter is in close proximity to your mobile device. Your mobile device will start searching automatically for the “Gluco+” meter. Select the one you would like to connect. The Bluetooth symbol on the meter will flash twice, then after three seconds, the meter turns off automatically.

Using the iHealth Gluco+ System - Blood Glucose Testing Instructions

1. Prepare the Wireless Smart Glucose Meter by charging the device.
2. Prepare the App (if using online testing). Open the app and click the “Measurement” button. Make sure your Bluetooth is turned on. The connection will be set up automatically.

3. Prepare the Lancing device
   1. Remove the lancing device cap
   2. Insert a new lancet firmly into the lancing holder cap
   3. Twist the lancet cover off (do not discard)
   4. Replace the lancing device cap
   5. Adjust the puncture depth setting. Set the lancet level from level 1 (Min) to 5 (Max)
   6. Twist until you hear a “click”

4. Clean your hands before blood collection
   1. Wash your hands with warm soapy water and dry thoroughly (Dirty or wet hands will impact results)
   2. Massage your fingers or shake hands out to push blood to your fingertips

Do not use iodine disinfectant, as it will lead to an inaccurate measurement.

5. Insert the test strip
   1. Take a new test strip from the test strip bottle, hold the middle of the test strip with the arrow facing the meter and insert the test strip into the meter’s strip port
   2. After inserting the test strip, the blood glucose meter will start up automatically. The blood dripping symbol flashes, indicating that the test strip is waiting for the blood sample. If the blood sample is not filled within 3 minutes, the meter will sleep automatically.

When inserting the test strip, do not touch the blood collection port with your finger. The contamination of the test strip will lead to an inaccurate measurement result. Use each strip promptly after removing it from the vial. Close the vial lid quickly after removing a new test strip. Do not use test strips that have been used or have expired.

6. Obtain a blood sample
   1. Press the lancet device against the site to be lanced. Press the release button to lance the site.
   2. Massage your finger until a drop of blood forms.

Do not squeeze the blood sample location as it will lead to an inaccurate measurement.

7. Read the test results
   1. 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.
   2. The meter begins to count down from 5 to 1 when the blood sampling port is full. The test result will appear on the display.

If the blood sampling port is not filled completely, do not add more blood to the test strip. Discard the test strip. Insert a new test strip before measuring.

8. Discard the test strip and lancet
   1. Push the eject button on the back side, discard the used test strip into a proper container to avoid contaminating other articles
   2. Insert the used lancet into the lancet cover to avoid exposing the needle tip. Push the remove lancet part slightly and discard the lancet properly.

After disposing of water test strips and lancet cover with blood, wash your hand thoroughly with soap and warm water.

9. Manage blood glucose data
   1. Download the “iHealth Gluco-Smart” app software from your relevant app store. Create a login and account.
   2. Turn on the mobile device’s Bluetooth. Search for and connect the Gluco+ meter when prompted by the app. Enjoy using the iHealth Gluco Smart App for intelligent personalisation services such as online measurement, data uploading, historical data viewing, glycemic trend analysis and more.

About the Offline Test (Taking a Measurement Without the Gluco-Smart App)

You can perform a blood glucose test without the iHealth Gluco-Smart app launched. Insert the test strip to start up a measurement. When you perform a blood glucose test without the app, your results will be saved on the meter. It can save up to 500 test results. To synchronise your result on your iHealth profile, launch the Gluco-Smart app and click “Upload.”

Data Synchronisation

The Gluco+ meter can save as many as 500 of the most recent blood glucose test results. When the meter needs to save a new test result and it has already stored 500 test results, the oldest results will be overwritten by the newest test result.

How To See Saved Test Results On The Gluco+ Meter

Short press the memory button to view the test results stored in the meter. The first reading you’ll see is your most recent blood glucose test reult. To view earlier test results, press the memory button repeatedly.

When you reach the last test result, the figure “- - -” will appear. The meter will turn off automatically when it is idle for 10 seconds.

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. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

Control Solution Tests

The iHealth Control Solution is intended to be used with the iHealth Wireless Smart Gluco Monitoring System (iHealth Gluco+). The iHealth Control Solution contains a specific quantity of glucose concentrate which reacts with the test strips, it’s used to verify the accuracy of blood glucose test results.

Materials needed to perform a control solution test:

iHealth Wireless Smart Glycose Meter

iHealth Test Strips (EGS-2003 & EGS-2043)

iHealth Control Solution (Level 1, Level 2, or Level 3)

Perform a control solution test when:

• The iHealth Control Solution is used to ensure the iHealth Wireless Smart Gluco Monitoring System is working correctly together and is not defective.

It should also be used in the following situations:

• First receiving or purchasing the meter.
• Each time you open a new vial of test strips.
• If you suspect a dysfunction of the meter or test strips.
• To familiarise yourself with the practice of testing.
• If you suspect that the results are not accurate.
• After the meter has been dropped.

Using the iHealth Test Strips

Use iHealth Test Strips EGS-2003 & EGS-2043. Do not use the test strips if expired. To keep your test strips in the best possible condition:

• Write the expiry date on the test strips vial when first opening.
• Store the test strips vial between 4 degrees C to 30 degrees C and 10% ~ 85% relative humidity.
• Keep the test strips away from direct sunlight.
• Test strips must be stored in their original vial only. Do not transfer them to a new vial or another container.
• Do not touch the test strips when your hands are wet.
• Use each strip promptly after removing a new test strip.
• Keep the vial lid closed at all times.
• Do not bend, cut or alter the test strips. Doing so will lead to inaccurate results.
• Do not use strips if the vial is damaged.

Each test strip can be used only once, and consists of the following parts:

Using the iHealth Lancing Device

• Use only with the iHealth Lancet and iHealth Control Solution. To store the Control Solution:
• Keep the Control Solution at a temperature between 2 degrees C and 30 degrees C and at a humidity rate of 10 to 85%.
• Do not expose Control Solution to direct sunlight or place it 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 it directly to the test strip from the bottle.

Dispose of used equipment according to regulations applicable in your country.

iHealth Gluco+ Glucometer Cleaning And Disinfection

Proper cleaning of the meter is essential, as it will help prevent infection and cross-contamination.

• Cleaning involves wiping the whole surface of the meter for 10 seconds, until there is no soil on the surface.
• Disinfection involves wiping the whole surface of the meter for 2 minutes - keeping the surface wet during this time.
• The meter and lancing device should be cleaned and disinfected at a minimum of once per week.
• Do not insert the disinfecting wipe into the test strip port.

The iHealth Wireless Smart Glucose Meter and iHealth Lancing Device are validated to support 10,000 cleanings over their lifespan.

Information About Alternate Site Testing (AST) - What is Alternate Site Testing?

Alternate Site Testing is the use of parts of the body, other than the fingertips, to check blood glucose levels. The iHealth blood glucose 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 AST, 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 AST should only be used under steady-state blood glucose levels.

What Is The Advantage Of Alternate Site Testing?

Pain is felt more readily on the fingertips because they are full of nerve endings. At other body sites where nerve endings are not so condensed, pain is not felt as acutely.

When Should You Use Alternate Site Testing?

Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood from the fingertips reflects these changes faster than capillary blood from other sites. Therefore, when testing blood glucose levels during or immediately after meals or exercise, or when another of the above noted conditions applies, take a blood sample from your fingertips only. AST should be used only during steady-state ties when glucose levels are not changing rapidly.

Alternate Site Testing is suitable in the following instances:

• In a pre-meal or fasting state (two hours or more after the last meal)
• Two hours or more after taking insulin
• Two hours or more after exercising

Do not perform AST if:

• You think your blood glucose is low
• You are unaware that yo umight have hypoglycemia
• You are testing for hyperglycemia
• Your AST results do not match the way you feel
• Your routine glucose results fluctuate often

iHealth Gluco+ Display Messages And Troubleshooting

“E1” is displayed

Strip removed during measurement. Start again using a new test strip.

“E2” or  “E4” is displayed

Problem with the meter. Retest with a new test strip. If the problem persists, call iHealth Labs Customer Service.

“E3” is displayed

Problems have occured 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. Retest using a new test strip.

“E5” is displayed

The environmental temperature is lower than 10 degrees C.

“E6” is displayed

The environmental temperature is higher than 40 degrees C.

“E7” is displayed

Communication error. Press and hold the MEMORY button for 7 seconds. This will restore the meter’s factory settings. Use the charging line to activate the meter.

“E8” is displayed

 Blood glucose level is lower than 20mg/dL (1.1mmol/L). Repeat the test using a new test strip. If your result still flashes Lo, seek medical advice immediately.

“E9” is displayed

Blood glucose level is higher than 600 mg/dL (33.3mmol/L). Wash and dry your hands and the test site thoroughly. Repeat the test using a new test strip. If your result still flashes HI, seek medical advice immediately.

Display remains blank after the test strip has been inserted into the meter

Possible Causes:

1. Battery power is too low
2. Too much time has passed between inserting the test strip and performing the test
3. The test strip has not been fully inserted into the meter

Solutions:

1. Charge the battery
2. Reinsert the test strip into the meter
3. Firmly reinsert the test strip into the meter.

Test results are inconsistent or Control Solution test results are not within the specified range

Possible Causes:

1. Not enough sample in the test strip
2. Test strip or Control Solution has expired
3. Test strip has been damaged due to heat or humidity so that the sample cannot be applied or the speed of application is too slow
4. System is not performing due to the environment being above or below room temperature

Solutions:

1. Retest with a new test strip and make sure that enough sample has been applied
2. Retest with a new test strip or new control solution
3. Perform a control solution test using a new test strip. If the results are still out of range, replace with a new vial of test strips
4. Bring the system to a room temperature environment and wait approximately 30 minutes before performing a new test

The meter countdown did not start

Possible Cause:

1. The strip has not been inserted correctly

Solution:

1. Use a new test strip and redo the test

The meter does not respond

Possible Cause:

1. System suspended

Solution:

1. Press and hold the MEMORY button for 7 seconds to restore factory settings. Use the charging line to activate the meter.

Limitations Of Use

The Gluco+ system is not intended for screening or diagnosis. It is also not intended for use on:

• Newborns
• Arterial or venous whole blood, serum or plasma
• People who are severely dehydrated
• People who are severely hypotensive
• People who are in shock
• People who are undergoing or have recently received xylose absorption therapy

Additional notes:

• Patients undergoing oxygen therapy may yield falsely lower results.
• The meter and lancing device are for single patient use.
• System is not for use on critically ill patients.
• Use only on fresh capillary whole blood samples to test your blood glucose.
• Very low or very high red blood cell count (hematocrit) can lead to incorrect test results.
• System is for self testing only.
• Do not use AST results to calibrate a continuous glucose monitor or for insulin dosing calculations.
• AST should only be used during times when blood sugar is not fluctuating rapidly, i.e. within 2 hours of eating, exercising or taking medication.
• If you take acetaminophen or acetaminophen containing medications, this might affect the readability of your blood glucose results. If you are unsure, ask your healthcare professional.
• Certain conditions may cause your blood glucose level of uric acid to rise. These conditions include gout or kidney disease. If your blood level of uric acid is high, your blood glucose results may not be reliable. If you are unsure, ask your healthcare professional.
• High levels of Vitamin C in your blood might cause inaccurate blood glucose results when using this blood glucose monitoring system.

Important Safety Instructions for the Gluco+

1. Do not change your therapy based on a test result that does not match what you feel or if you believe that your test result could be incorrect.
2. Misuse of the iHealth Wireless Smart Gluco-Monitoring System can cause electrocution, burns, fire and other hazards.
3. If your blood glucose result does not match what you feel and you have followed the instructions in this Owner’s Manual, follow your healthcare professional’s instructions or contact your healthcare professional.
4. Always use a new, sterile lancet each time you test to avoid infection. For safety reasons, each time you use a new lancet, you cannot go back to a used lancet. Never reuse any lancet.
5. Do not swallow and keep away from children.
6. The meter and lancing device are for single patient use. Do not use either item on multiple patients. Never share the meter or lancing device with anyone - including family members.
7. Do not place the system on or near liquid.
8. The system can be used up to an altitude of 3275 metres.
9. Use the system only for the purpose described in the Owner’s Manual.
10. Use only the accessories that are supplied by the manufacturer.
11. Do not use the iHealth system if it has sustained any damage or if it is not working properly.
12. Keep the system away from heat at all times. Do not let it come into contact with surfaces that are hot to the touch.
13. Do not block the test port or place the iHealth system on soft surfaces that may block the test port. Keep the test port free from lint, hair, debris, etc.
14. Do not place anything on top of the system.
15. Do not place foreign objects into any opening in the system.
16. Do not use the meter in a manner not specified by the manufacturer.
17. All parts of the iHealth system are considered biohazards and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.