KetoCoach S11006 User manual

KetoCoach™ Blood Ketone Monitoring System
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Dear KetoCoach™Owner aka Awesome Person
You did it! You're making an effort to improve your health through measuring ketones.
You're awesome. And we're honored to be along for the journey.
First of all, thank you for choosing the KetoCoach™ Blood Ketone Monitoring System
to help you accurately monitor your blood ketone level. Your new KetoCoach™
Blood Ketone Monitoring System is an autocoding system that does not require you
to manually select the correct calibration (commonly known as "coding the meter").
Pretty cool! All of the information you need to use and maintain the KetoCoach™
Blood Ketone Monitoring System is included in this manual. Before you begin using
your new KetoCoach™ Blood Ketone Monitoring System, please read all of the
instructions provided in this User’s Manual, then follow the
instructions in test strips package insert.
For questions or support, please visit our website at www.ketocoachx.com or call
1-800-587-5496. We're here to help you have a great experience with our product.

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Intended Use
The KetoCoach™ Blood Ketone Monitoring System is intended to quantitatively
measure β-hydroxybutyrate (β-ketone) in fresh capillary whole blood from ngertips.
It should only be used by a single patient and it should not be shared. Testing is done
outside the body (In Vitro diagnostic use). It is intended for self-testing by people
with diabetes at home as an aid to monitoring the effectiveness of diabetes control
programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal
use.
The KetoCoach™ Blood Ketone Monitoring System is comprised of the KetoCoach™
Blood Ketone Meter and KetoCoach™ Blood Ketone Test Strip and KetoCoach™
Ketone Control Solution.
IMPORTANT:
• Dehydration – Severe dehydration may lead to inaccurate blood ketone test result.
If you suspect you are severely dehydrated, contact your healthcare professional
immediately.
• A hematocrit range that is higher than 60% or lower than 20% can cause inaccurate
blood ketone test results.
• Suitable for self-testing.
• Not intended for use on neonates.

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Important Safety Instructions
• The meter and lancing device are for single patient use. Do not share them with
anyone including other family members. Do not use on multiple patients.
• All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfection.
• Users should wash hands thoroughly with soap and water after handling the meter,
lancing device, or test strips.
The link of public health notications and standard practice guidelines are :
• “FDA Public Health Notication: Use of Fingerstick Devices on More than One
Person Poses Risk for ransmitting Bloodborne Pathogens: Initial Communication”
(2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
• “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html
Limitations
1. The system should not be used to test neonates.
2. Do not test samples other than fresh capillary whole blood obtained from the
ngertip.

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3. Do not use the system at altitudes above 10,335 feet (3,150meters).
4. Do not use when Hematocrit is outside the acceptable hematocrit range for
testing of 20% to 60%.
5. Severe dehydration (excessive water loss) may cause inaccurate results. If
you believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
6. For in vitro diagnostic use only.
7. Critically ill patients should not be tested with this device.
8. Inaccurate results may occur in severely hypotensive individuals or patients in
shock or in a hyperglycemic-hyperosmolar state.
9. Incorrect result may occur in individuals who are dehydrated.
10. The meter and lancing device are for single patient use. Do not share these items
with anyone, including other family members! Do not use on multiple patients!
11. Do not reuse; each test strip is for single use only.
12. Do not use when humidity is higher than 90% and lower than 20%, as extremes
in humidity may affect results.
13. For single patient use only.
14. For over-the counter use.
15. The system is not intended for use in the diagnosis of or screening for diabetes
mellitus.

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Table of Contents
Understanding Your KetoCoach™ Blood Ketone Monitoring System............ 7
The KetoCoach™ Meter ............................................... 8
The KetoCoach™ Meter Display Screen .................................. 10
The KetoCoach™ Blood Ketone Test Strip ................................ 12
Setting Up Your New System ............................................ 13
Inserting (or Changing) the Battery ...................................... 13
Setting the Clock .................................................... 15
Setting the Alarm .................................................... 19
Turning ON/OFF Tone Sound .......................................... 21
Control Solution Testing................................................ 24
Performing a Ketone Control Solution Test ................................ 24
Control Solution Troubleshooting........................................ 30
Testing your Blood Ketones............................................. 31
Preparing Your Lancing Device ......................................... 32
Performing a Blood Ketone Test ........................................ 34

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Understanding Your Test Results ........................................ 38
Understanding Your Blood Ketone Test Results ............................ 38
Viewing Stored Readings from Memory ................................... 40
Viewing Stored Readings of Ketone Test Results from Memory ................ 40
Caring for the Meter ................................................... 43
Cleaning the Meter................................................... 43
Storage and Precautions .............................................. 48
Solving Problems ..................................................... 50
Product Warranty ..................................................... 54
Specications ........................................................ 55
Supplies ............................................................. 56

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Understanding Your KetoCoach™ Blood Ketone Monitoring System
Each KetoCoach™ system may include the following items:
Note:
• Contents may change without notice.
• Lancets and Lancing Device are optional components.
• KetoCoach™ Blood Ketone Test Strip, KetoCoach™ Ketone Control Solution are
necessary but sold separately.
Please contact us at www.ketocoachx.com for purchasing information.
Lancing Device
User Guide
KetoCoach™
Level 2 Ketone
Control Solution
Lancets
The KetoCoach™ Meter
The KetoCoach™ Blood
Ketone Test Strip
(vial or foil-wrapped)

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The KetoCoach™ Meter
Test Strip Port
This is where you insert the test strip and the
meter will turn on automatically.
Meter Display
Show your test results, memory values, average,
and other messages.
Enter ( ) and ▲▼buttons
Press and hold ( ) for 2 seconds to turn the
meter on or off, or press ( ) to go into setup
mode when not testing.
Press ▲or▼to enter control mode with test strip
inserted, during meter setup, or to navigate the
stored test values and averages.

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Ejection Switch
Push and eject a used test strip. Meter will turn
off automatically when the test strip is ejected.
The USB is not active in this meter.
Battery Compartment
Holds two CR 2032 3V Lithium coin cell batteries.

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The KetoCoach™ Meter Display Screen
BEEPER
ALARM/ CLOCK
MEMORY
MAIN DISPLAY
AREA
UNIT
HOUR/MINUTES
BLOOD DROP
TEST STRIP
TEMPERATURE
BATTERY
CONTROL SOLUTION
MODE (CTRL)

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MAIN DISPLAY AREA.....Displays test results, stored test values, calculated result
averages, and messages
MEMORY ........................Indicates the number in the main display area is a stored
test value (see page 40)
BATTERY........................Appears when the battery is low and needs to be replaced
TEMPERATURE .............Appears when it is either too hot or too cold to test (outside
the ranges 50°F~104°F for ketone test)
TEST STRIP....................This icon will ash to prompt you to insert a test strip for
testing
UNIT ................................Unit of measurement for your blood ketones
CTRL ...............................Indicates a control solution test (see page 24)
BEEPER..........................Appears when turning ON/OFF tone sound (see page 20)
ALARM ............................Indicates the alarm function is on (see page 19)
CLOCK ............................Appears when setting date and time (see page 15)
BLOOD DROP.................This icon will ash to indicate the meter is ready for testing

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The KetoCoach™ Blood Ketone Test Strip
The KetoCoach™ Blood Ketone Test Strip is ketone specic, biosensor-based test
strip that can test blood ketone levels in capillary whole blood in as quickly as 8
seconds and requires very little blood sample. The test result is plasma referenced for
easy comparison to lab results and has under-ll detection to alert you when there is
not enough blood to perform a test, so you can be assured that each reading you get
is an accurate and meaningful result when the control reading is within the specied
range.
IMPORTANT:
• Be sure to use only the KetoCoach™ Blood Ketone Test Strip with the
KetoCoach™ Meter. Other brands of test strips will not work with the meter.
• The KetoCoach™ Blood Ketone Test Strip is sensitive to moisture and light. For
vial test strips, it is important to close the vial cap of the test strip bottle tightly after
each use. DO NOT leave any test strips outside the bottle while not in use.
• Carefully discard used test strips and lancets in proper waste containers according
to your healthcare provider’s instructions.
• DO NOT reuse test strip. The test strip is for single use only.
Contact Points
Insert this end to the test
strip port on the meter
Sampling End
Apply blood or control solution
here

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Setting Up Your New System
Inserting (or Changing) the Battery
The batteries need to be inserted before using your KetoCoach™ Meter
for the rst time or when the “ ” icon appears on the meter display
screen.
Material you will need:
• Two CR 2032 3V Lithium coin cell batteries
• Your KetoCoach™ Meter
Step 1.
Turn meter off. Remove the battery cover on the back of the
meter by pushing the tab and pulling the door up. Remove the old
batteries.

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Step 2.
Insert the new batteries with the + side up. They do not snap into
place but rest on the metal contact. The door holds the batteries
down.
Put the battery door back in place and snap it closed.
NOTE:
• After changing the batteries, the meter automatically prompts you to check the time
and date when it is turned on either by inserting a test strip or pressing “ ”. If it is
correct, press “ ” to conrm setup and exit, or if the time and date are not correct,
turn to page 15 for Setting the Clock.
• The date and stored results will not be erased when the batteries are being
changed.
• Discard used batteries according to your local regulation.
• The meter uses two 3-volt lithium batteries, coin cell CR2032. This type of battery
can be found in many stores. Always keep a spare packaged battery on hand.
• Be sure the batteries go in + side up.
• Remove the batteries if unused for a long time.

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Setting the Clock
Material you will need:
• Your KetoCoach™ Meter
Begin Set Up
Step 1.
Press and hold “ ” to turn on the meter.
Step 2.
The ashing test strip icon will appear on the meter display screen.
Step 3.
Press “▲” twice and the meter display screen shows “ ”.

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Set Year
Step 4.
Press “ ” and the current year will ash. Use “▲” or “▼” to select the
correct year.
Press “ ” to conrm your choice and advance to set the month.
Set Month
Step 5.
The current month will ash. Use “▲” or “▼” to select the correct
month.
Press “ ” to conrm your choice and advance to set the day.
Set Day
Step 6.
The current day will ash. Use “▲” or “▼” to select the correct day.
Press “ ” to conrm your choice and advance to set the 12-hour or 24-
hour time format.

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Set 12-hour or 24-hour Time Format
Step 7.
The time format will ash. Use “▲” or “▼” to select the time format of
your choice.
Press “ ” to conrm your choice and advance to set the hour.
Set Hour
Step 8.
The current hour will ash. Use “▲” or “▼” to select the correct hour.
Press “ ” to conrm your choice and advance to set the minutes.
Set Minutes
Step 9.
The current minutes will ash. Use “▲” or “▼” to select the correct
minutes.
Press “ ” to conrm your choice and exit time setup.

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NOTE:
• Anytime during setup, you may either press “ ” to exit, or insert a KetoCoach™
Blood Ketone Test Strip to begin testing. The changes you have done so far will be
memorized by the meter.
After setting up your clock, you can turn off the meter by holding and pressing “ ”,
continue to set your meter, or insert a test strip to begin testing (see Testing Your
Blood Ketone on page 31, or Control Solution Testing on page 24).

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Setting the Alarm
You can set up to three alarms for ketone testing on your KetoCoach™ Meter. You
must set the clock before setting the alarms. When an alarm rings, a melody will play
for 20 seconds. Pressing “ ” or inserting a test strip will silence the alarm.
Materials you need:
•Your KetoCoach™ Meter
Step 1.
Press and hold “ ” to turn on the meter.
Step 2.
The ashing test strip icon will appear on the meter display screen.
Step 3.
Press “▲” or “▼” until “ ” starts to ash. Press “ ” to enter alarm
setting.

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Step 4.
The display screen will indicate alarm 1 status (the default is OFF).
You can turn it on by pressing “▲” or “▼”. Press “ ” to conrm your
choice and advance to set the hours.
Step 5.
The hours will ash. Press “▲” or “▼” to select the hour. Press “ ” to
conrm your choice and advance to set the minutes.
Step 6.
The minutes will ash. Press “▲” or “▼” to select the correct minutes.
Press “ ” to conrm your choice and advance to set alarm 2.