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.

KetoCoach™ Blood Ketone Monitoring System
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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)