VivaChek VGM200 User manual

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VivaChek GLU & KET User's manual Cover(En)
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1205091101
2019-08

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Blood Glucose and β-Ketone Monitoring System
Dear VivaChek™ System User,
Thank you for choosing the VivaChek™ Blood Glucose and β-Ketone Monitoring
System! VivaChek™ Blood Glucose and β-Ketone Monitoring System is designed
for easy test of blood glucose/β-ketone and helps you keep them under control.
Read this User’s Manual carefully before you use your system. Please keep your
User’s Manual in a safe place, you may want to refer it in the future.
Thank you again for choosing the VivaChek™ System.
Intended Use and Principle
VivaChek™ Blood Glucose and β-Ketone Monitoring System is comprised of the
VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Blood
Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips
(VKS01). Glucose measurement is based on electrochemical biosensor
technology using the enzyme Glucose Dehydrogenase to catalyze the formation of
gluconolactone from the oxidation of glucose whereby two electrons are produced.
The electrical current resulting from this enzymatic reaction is proportional to the
concentration of glucose in the sample and is measured by the meter. The meter is
calibrated to display the equivalent of plasma glucose values. Using the same
technology, β-ketone is converted by β-hydroxybutyrate dehydrogenase and the
magnitude of electrical current resulting from this enzymatic reaction is
proportional to the amount of β-hydroxybutyrate present in the sample.
The System is intended to quantitatively measure the glucose and β-ketone
concentration in fresh capillary whole blood samples drawn from the fingertips. It is
intended for self-testing outside the body (in vitro diagnostic use) by people with
diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not
intended for neonatal use or for the diagnosis of or screening for diabetes. This
system is intended to be used by a single person and should not be shared.
The System is not intended for use in healthcare or assisted-use settings such as
hospitals, physician offices, or long-term care facilities because it has not been
cleared by FDA for use in these settings. Use of this system on multiple patients
may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C
Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

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TABLE OF CONTENTS
1. Understanding Your Testing Tools…………………………………......
1
Your Meter System Overview…………………………………………......
1
Your Meter Display……………………………………………………...….
2
Important Safety Information………………………………………………
4
Limitations…………………………………………………………………...
5
2. Setting Up Your System…………………………………………...……..
6
Set the Time and Date…………………………………………………......
6
Set the Audio Feature………….……………………………….....……….
8
Set the Test Alarm……………………………………………....…………..
8
Set the Meal Marker..............................................................................
9
Set the Hypoglycemia (Hypo) Alarm.....................................................
9
Set the Ketone Warning…………………………………………....………
10
Pairing Your Meter with the Smart Phone……………………..…………
10
Using Your Meter without the App……………………………..………….
11
3. Taking a Test…………………………………………………………….....
12
Preparing the Test Strip…………………………………………………....
12
Getting a Blood Drop and Testing…………………………………………
12
Discard the Used Test Strip…..…………………………………………...
14
Expected Blood Glucose/β-Ketone Control Goal..................................
14
Taking a GKI Testing.............................................................................
16
Questionable or Inconsistent Results....................................................
18
Testing with Control Solution…………………………….……………......
18
Using the Meter Memory…………………………………………………..
21
4. Maintenance and Troubleshooting……………………………….........
23
Replace the Battery………………..……………………………………….
23
Caring for Your Monitoring System……………...............……………….
24
Cleaning and Disinfection………………………………………………….
24
Troubleshooting Guide……………………………………………………..
26
Symptoms of High/Low Blood Glucose and Ketoacidosis……………...
27
5. Technical Information…………………………………………………….
28
System Specifications……………………………………………………...
28
Warranty……………………………………………………………………..
31

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CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS
Your Meter System Overview
The VivaChek™ Blood Glucose and β-Ketone Meter and Test Strips

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Your Meter Display
The picture below shows all the symbols that appear on your meter display.
Please make sure the display is working properly before testing. When the meter is
off, press and hold power button to see the complete display. All display segments
will appear. If you need more time to check the display, repeat the above operation.
All of the segments should be clear and exactly like the picture below. If not,
contact VivaChek Customer Support at 888-969-6928 (7 days a week. 9 a.m.-5
p.m. Eastern Time) for help. Please contact your healthcare professional if you
need help outside of these hours.
Icon
What it Means
The top left area on the screen indicates the date.
The top right area on the screen indicates the time.
The top middle area on the screen indicates morning or
afternoon time.
Indicates the display form of date and month have been set.
Indicates success Bluetooth communication.
Indicates failure Bluetooth communication.
Indicates the alarms have been set.

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Blood glucose test mode.
Blood β-ketone test mode.
GKI
Glucose ketone index (GKI) test mode.
Indicates a low battery or it needs to be replaced.
Indicates average value.
Indicates test result history.
Center area on the display that shows test results or error
codes.
Indicates the system is ready to test.
Control test result.
Pre-meal marker.
Post-meal marker.
Blood glucose test results are displayed as mg/dL and blood
β-ketone test results are displayed as mmol/L.
Indicates the temperature is not suitable for testing.
Ketone warning.
Indicates that a low test result may cause hypoglycaemia.
Notes:
Your VivaChek™ Blood Glucose and β-Ketone Meter is pre-set with beep sound
function, the meter will beep when:
•turn on the meter.
•set the date and time.
•set the test mode.
•the test strip is inserted and ready to apply blood or control solution.
•sufficient blood or control solution is pulled into the test strip.
•the test is complete.
•it is time to perform a test if you set the test alarms.
•if any error occurs during operation.

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Meter Use and Precautions
•The meter is preset to display blood glucose concentration in milligrams per
deciliter (mg/dL) by default. And meter is preset to display blood β-ketone
concentration in millimoles per liter (mmol/L) by default. The unit of measure
cannot be adjusted.
•Do not get water or other liquids inside the meter.
•Keep the strip port area clean.
•Keep your meter dry and avoid exposing it to extreme temperatures or humidity.
Do not leave it in your car.
•Do not drop the meter or get it wet. If you do drop the meter or get it wet, check
the meter by running a quality control test. Refer to Quality Control Test for
instructions.
•Do not take the meter apart. Taking the meter apart will void the warranty.
•Refer to the Caring for Your Meter section for details on cleaning the meter.
•Keep the meter and all associated parts out of reach of children.
Note: Follow proper precautions and all local regulations when disposing of the
meter and used batteries.
Important Safety Information
•The meter is single patient use. Do not share them with anyone including
other family members! Do not use on multiple patients!
•Do not use the meter if it is dropping into water or splashing water on to it.
•Wash and dry your hands well before and after testing.
•Test strips and safety lancets are for single use only.
•Do not drop blood directly on the flat surface of the test strip.
•Check the expiration dates and discard dates on your test strips vial label
(or on the foil pouch) and control solution bottle label.
•Use only VivaChek™ Blood Glucose/β-Ketone Test Strip with your
VivaChek™ Blood Glucose and β-Ketone Meter.
•Use only VivaChek™ Blood Glucose/β-Ketone Control Solution with your
VivaChek™ Blood Glucose and β-Ketone Meter and VivaChek™ Blood
Glucose/β-Ketone Test Strip.
•Please contact your physician or diabetes healthcare professional if you
determine to make a change on your current medical therapy or diet activity
based on test results.
•If the system is used in a manner not specified by the manufacturer,
the protection provided by the system can be impaired.
Potential Biohazard
All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfection.

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Note:
1. The meter is for single patient use. Do not share them with anyone including
other family members! Do not use on multiple patients!
2. All parts of the kit are considered biohazardous. They can potentially transmit
infectious diseases from blood borne pathogens, even after you have
performed cleaning and disinfection. Please follow proper precautions when
handling your meter.
3. For more information, please refer to the FDA Public Health Notification: “Use
of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010) at
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
You may also refer to the CDC Clinical Reminder: “Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
Limitations
•For single-patient use only.
•The system is tested to accurately read the measurement of glucose in
fresh capillary whole blood within the range of 20 to 600 mg/dL and
β-ketone in fresh capillary whole blood within the range of 0.1 to 8.0 mmol/L.
•Very high (above 70%) and very low (below 20%) hematocrit levels can
cause false results for blood glucose testing, and very high (above 65%)
and very low (below 20%) hematocrit levels can cause false results for
blood β-ketone testing. Talk to your healthcare professional to find out your
hematocrit level.
•Patients undergoing oxygen therapy may cause false results.
•Severe dehydration (excessive water loss) may cause inaccurate results.
•Not for neonatal use.
•Not for use on patients with critical illness.
•Not for use in severely hypotensive individuals or on patients in shock or in
a hyperosmolar state.
•Not for screening or diagnosis of diabetes.
•Do not use the system at altitudes above 13123ft (4000 meters) above sea
level for blood glucose testing and 8700 ft (2651 meters) above sea level for
blood β-ketone testing.
•Do not use when humidity is higher than 90% and lower than 10%, as
extremes in humidity may affect results.
•For in vitro diagnosis use only.
•The system is not intended for use in healthcare or assisted-use settings
such as hospitals, physician offices, or long-term care facilities because it
has not been cleared by FDA for use in these settings.

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CHAPTER 2: SETTING UP YOUR SYSTEM
Before you first time using your meter or if you change your meter batteries, you
should check and update your meter settings.
Set the Date and Time
1. Enter the setting mode and set the clock
When the meter is off, press and hold the power button for more than 2 seconds
until the meter beeps to enter the set up mode. Press the side button to adjust the
set of clock for 12 or 24 hour mode, then press the power button to save your
choice. Start setting the display form of date.
2. Set the date display form
The date icon will now flash, press the side button to adjust the set of date display
form for d/m or m/d mode, then press the power button to save your choice. Start
setting the date.
3. Set the date
The year will now flash. Press the side button to adjust it and press power button.
Then it will shift to next digit for setting. Repeat the above action until the year
setting is completed, then press the power button until the meter beeps to set.
The month will now flash. Press the side button to adjust it and press power
button. Then it will shift to next digit for setting. Repeat the above action until the
month setting is completed, then press the power button until the meter beeps to
set.

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The date will now flash. Press the side button to adjust it and press power button.
Then it will shift to next digit for setting. Repeat the above action until the date
setting is completed, then press the power button until the meter beeps to set.
4. Set the Time
The hour will now flash. Press side button to adjust the current hour and press
power button. Then it will shift to next digit for setting. Repeat the above action
until the hour setting is completed, then press the power button until the meter
beeps to set.
The minute will now flash. Press side button to adjust the minute and press
power button. Then it will shift to next digit for setting. Repeat the above action
until the minute setting is completed, then press the power button to set.
Note:
Before you first time use your meter system for testing, please adjust the meter
settings to set the date and time, ensuring that results stored in the memory are
shown with the correct date and time.

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Set the Audio Feature
After setting the date and time, press the power button until the meter beeps to
set, the beep will now flash. Press the side button to set ON or OFF, press the
power button to save the audio setting.
Set the Test Alarm
After the audio setting is completed, the meter will enter the test alarm setting
mode, the reminder function reminds users to take a measurement. Your meter is
pre-set with the test alarm function to “OFF”, you can set up to 5 reminders per day.
If you turn 5 test alarms on (A1, A2, A3, A4 and A5), your meter is pre-set with the
following times for your convenience, you can adjust each time to suit your needs.
A1 7:00 A2 9:00 A3 14:00 A4 18:00 A5 22:00
Before you set the time, the and the word “OFF” will be displayed, symbol “A1”
flashes. Press side button to turn the alarm function on or off, and press power
button to save.
If you select “On”, the hour flashes, “A1” and the remain on the display. Press
side button to select the hour. Press power button to set.
The minute flashes, press side button to select 00, 15, 30, or 45. These are the
only choices. Press power button to set minutes.

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The next alarm “A2” flashes on the display with and “OFF”.
You can either set a second alarm by press side button to turn on the second
alarm. Do the same procedures to set the rest alarms.
Note: If the meter is on at the test reminder time, the test alarm does not occur.
Set the Meal Marker
After setting the test alarm functions, the symbols of will now flash, along
with word “On” on the display. Press side button to turn the meal marker function
on or off, press power button to set.
Set the Hypoglycemia (Hypo) Alarm
After setting the meal marker, you can set the hypo alarm, which indicates a
possible hypoglycemic condition (blood glucose level is too low).
Before you set the hypo alarm, the flashes along with “On” on the display.
Press side button to turn the Hypo alarm function on or off, press power button to
set. If you select the hypo alarm “on”, the display shows 70 mg/dL (as default).
Press power button to set.

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Note:
•Talk to your healthcare professional to help you decide the hypo level that suit
for your situation.
•For healthcare professionals, the hypoglycemic level may vary from person to
person. It is recommended to turn the hypo alarm function OFF when using the
meter in a professional facility.
Set the Ketone Warning
After the hypo alarm setting is completed, the symbol will now flash,
along with word “On” on the display. Press side button to turn the Ketone Warning
on or off, press power button to set.
After setting Ketone Warning, the screen will show all symbols which you have set
before. Press power button and the meter will turn off.
Once all the settings are completed, if you want to change the setting, please press
and hold the power button when the VivaChek™ Blood Glucose and β-Ketone
Meter is off and then return to the setting mode.
Pairing Your Meter with the Smart Phone
Pairing prepares your VivaChek™ Blood Glucose and β-Ketone Meter and Smart
Phone to communicate with each other. The distance between the meter and smart
phone should be within 5 meters. Download the XXXXX App before pairing your

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meter with smart phone.
Note: XXXXX App is compatible with Android 4.1 above, and iOS 8.0 above
operating system.
WARNING
DO NOT pair another person’s meter with your Smart Phone.
To pair the Smart Phone with your meter, start with your meter on and follow these
steps:
1. Turn on your meter.
2. Turn on Bluetooth®on your Smart Phone.
3. Open the APP on your Smart Phone.
4. Select searching my device on the APP.
5. Look for a meter named VivaChek.
6. Tap on the meter named VivaChek.
7. Enter your meter pass code using the keypad. The pass code is the last 5
digits from the Serial Number on the back of your meter.
8. Tap Pair
9. Wait for the Smart Phone status to say “√”. Congratulations! Your meter and
Smart Phone are now paired.
10. After pairing the meter with your Smart Phone, the Smart Phone will Sync date
and time on your meter.
11. The “Syncing Data” will appear on the App with the symbol to notify you
that the meter is communicating with the app. Tap the symbol , and then the
meter will send test results to the Smart Phone.
12. After syncing data between meter and the Smart Phone, the App will display all
data of test result from meter.
Using Your Meter without the App
The meter can be used without a Smart Phone or the App. You can still test your
blood glucose/β-ketone and review your test results on the meter screen.
Your meter automatically stores up to 1000 results with the time and date. Test
results are stored from the newest to the oldest. If there are already 1000 records
in memory, the oldest record will be erased to make room for a new one.

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CHAPTER 3: TAKING A TEST
Set up your meter correctly and have all the materials you will need ready before
you begin testing. This including your VivaChek™ Blood Glucose and β-Ketone
Meter, VivaChek™ Blood Glucose Test Strips, VivaChek™ Blood β-Ketone Test
Strips and VivaChek™ Safety Lancets.
Preparing the Test Strip
1. Wash and dry your hands well before testing.
2. Remove a test strip from the test strip vial (or the foil pouch). Tightly close the
vial cap immediately after you have removed the test strip.
3. Insert the test strip into the meter in the direction of the arrows.
4. A symbol with a test strip with a flashing blood ( ) will appear
letting you know the meter is ready to test.
Note:
Check the expiration and discard dates on the test strip vial (or the foil pouch). All
expiration dates are printed in Year-Month format. 2021/01 indicates January,
2021. Make sure the test strip does not appear damaged. Prior to testing, wipe and
dry the test site with an alcohol swab or soapy water. Make sure there is no cream
or lotion on the test site.
Getting a Blood Drop and Testing
Here is an example of how to use a VivaChek™ Safety Lancet for fingertip blood
sampling. If you use a different single-use auto-disabling safety lancet or lancing
device, please follow the manufacturer’s instructions.
1. Carefully rotate and pull off the protective cap.
Avoid placing your thumb or fingers over the
uncapped end of the safety lancet.
2. Hold the safety lancet against the puncture site. Note:
Before using a single-use auto-disabling safety
lancet for blood sampling, wash both hands with
soap and warm water and disinfect the puncture site

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with a topical skin antiseptic such as an alcohol swab.
3. Gently press the safety lancet against the puncture
site to lance the skin. Listen for an audible click. This
indicates that the safety feature of the device has
been activated. Dispose of the lancet in an
appropriate biohazard sharps container. Please see
the Caution Statement.
4. Gently massage from the surrounding area toward
the puncture site to collect the required blood volume.
For the greatest reduction in pain, lance on the sides
of the fingertips. Rotation of sites is recommended.
Repeated punctures in the same spot can make
fingers sore and callused.
Caution Statement
Do not use the single-use auto-disabling safety lancet if the cap is missing
or loose.
Always use a new, sterile single-use auto-disabling safety lancet. Do not
reuse the single-use auto-disabling safety lancet.
Avoid getting the single-use auto-disabling safety lancet dirty with hand
lotion, oil, dirt or debris.
Single-use auto-disabling safety lancets appropriate biohazard sharps
container. If a biohazard sharps container is not available use a heavy duty
plastic container such as a laundry detergent bottle. Ensure the container is
leak-resistant and has a hard puncture proof lid. Do not place loose sharps
into the trash and do not flush down the toilet. Do not place sharps into the
recycle bin as they are not recyclable.
5. Immediately touch the tip of the test strip to the drop of blood. The blood
pulled into the test strip through the tip. Make sure that the blood sample
has been fully filled the check window on the strip tip. Hold the tip of the test
strip in the blood drop until the meter beeps.
Note:
If the blood sample does not fill the check window, do not add a second drop.
Discard the test strip and start over with a new test strip.

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6. For blood glucose testing, the meter counts down from 5 to 1, and for blood
β-ketone testing, the meter counts down from 9 to 1. And then the result
appears on the display. The test result will automatically be stored in the
meter memory. Please do not touch the test strip during the countdown as
this may result in an error.
Discard the Used Test Strip
You can discard the used test strip by slide the strip ejector to the direction of arrow.
Meter turns off automatically after a beep.
Potential Biohazard
Dispose of the used test strips as medical waste.
Note:
1. The meter is for single patient use. Do not share them with anyone including
other family members! Do not use on multiple patients!
2. All parts of the kit are considered biohazardous. They can potentially transmit
infectious diseases from blood borne pathogens, even after you have
performed cleaning and disinfection. Please follow proper precautions when
handling your meter.
Expected Blood Glucose/β-Ketone Control Goal
1. Blood Glucose Reference Ranges
Expected blood glucose values for people without diabetes:1
Time of Day
Glucose Range
Fasting and before Meals
<100 mg/dL
2 hours after meals
<140 mg/dL
Warning:
•If your blood glucose result is below 50 mg/dL or above 250 mg/dL, it may
indicate a potential serious medical condition, please contact your healthcare

15
professional as soon as possible.
•Please contact your physician if you determine to make a change on your
current medical therapy based on test result.
2. Blood β-Ketone Reference Ranges
The blood β-ketone test measures beta-hydroxybutyrate, an important ketone
body in the blood.2Normally, levels of beta-hydroxybutyrate are expected to be
less than 0.6 mmol/L.3
Beta-hydroxybutyrate may increase if a person fasts, exercises vigorously or has
diabetes and becomes ill.2,4 If your blood β-ketone result is lower than 0.1 mmol/L
and your blood glucose result is 300.0 mg/dL or higher, repeat both the β-ketone
and glucose tests with new test strips. If the same result appears again or the
result does not match with how you feel, contact your healthcare professional.
Follow your healthcare professional’s advice before you make any changes to your
diabetes medication programme.
If your blood β-ketone result is between 0.6 and 1.5 mmol/L and your blood
glucose result is 300.0 mg/dL or higher, this may indicate development of a
problem that could require medical assistance. Follow your healthcare
professional’s advice.
If your blood β-ketone result is higher than 1.5 mmol/L and your blood glucose
result is 300.0 mg/dL or higher, contact your healthcare professional promptly for
advice and assistance. You may be at risk of developing diabetic ketoacidosis
(DKA).3-7
References:
1. American Diabetes Association. Standards of Medical Care in Diabetes.
Diabetes Care 2018; vol.41 (supplement 1): S13-S27.
2. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special
Topics in Endocrinology and Metabolism 1982; 4: 1-27.
3. Wiggam MI, O’Kane MJ, Harper R, Atkinson AB, Hadden DR, Trimble ER, Bell
PM. Treatment of diabetic ketoacidosis using normalization of blood
3-hydroxybutyrate concentration as the endpoint of emergency management.
Diabetes Care 1997; 20: 1347-1352.
4. Harano Y, Kosugi K, Hyosu T, Suzuki M, Hidaka H, Kashiwagi A, Uno S,
Shigeta Y. Ketone bodies as markers for Type 1 (insulin-dependent) diabetes
and their value in the monitoring of diabetes control. Diabetologia 1984; 26:
343-348.
5. Ubukata E. Diurnal variation of blood beta-Ketone bodies in insulin-dependent
diabetes mellitus and noninsulin-dependent diabetes mellitus patients: The
relationship to serum C-Peptide immuno reactivity and free insulin. Ann Nutr
Metab 1990; 34: 333-342.
6. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzo RA. Metabolic effects of
low-dose insulin therapy on glucose metabolism in diabetic ketoacidosis.
Diabetes 1988; 37: 1470-1477.
7. Hale PJ, Crase J, Nattrass M. Metabolic effects of bicarbonate in the treatment
of diabetes ketoacidosis. Br Med J 1984; 289: 1035-1038.

16
Taking A GKI Testing
You will know your GKI (Glucose Ketone Index) result after performing blood
glucose and blood β-ketone test.
1. Enter GKI testing mode
When meter is on, press power button for 3s, the symbol of GKI and a test strip
will both flash, then press power button again to confirm.
2. Performing Blood Glucose Testing
The symbol of “GLU”, “GKI” and a test strip will appear letting you know the meter
is ready to test blood glucose.
Insert the VivaChek™ blood glucose test strip into the meter, the symbol of a test
strip with flashing blood will appear letting you know the meter is ready to test.
Immediately touch the tip of the test strip to the drop of blood, the meter counts
down from 5 to 1, your blood glucose result appears on the display after a beep.
The test result will display for 1 second and automatically be stored in the meter
memory, then the meter turns to blood β-ketone testing.

17
3. Performing Blood β-Ketone Testing
The symbol of “KET”, “GKI” and a test strip will appear letting you know the meter
is ready to test blood β-ketone.
Insert the VivaChek™ blood β-ketone test strip into the meter, the symbol of a test
strip with flashing blood will appear letting you know the meter is ready to test.
Immediately touch the tip of the test strip to the drop of blood, the meter counts
down from 9 to 1, your blood β-ketone result appears on the display after a beep.
The test result will display for 1 second and automatically be stored in the meter
memory, then the meter turns to GKI testing.
4. Understanding your GKI Result
One second after the blood β-ketone result displayed on the screen, the meter will
display GKI result permanently, and store it in memory.