Owner's Manual
-Ketone & Blood Glucose
Monitoring System
TD-4279
3
Dear TD-4279 keto-mojo System Owner:
Thank you for purchasing the TD-4279 -Ketone & Blood Glucose
Monitoring System. This manual provides important information to help
you to use the system properly. Before using this product, please read
the following contents thoroughly and carefully.
The System measures both blood glucose and -ketone. Regular
monitoring of your blood glucose and -ketone levels can help you and
your doctor gain better control of your diabetes. Due to its compact
size and easy operation, you can use the TD-4279 -Ketone & Blood
Glucose Monitoring System to easily monitor your blood glucose and
-ketone levels by yourself anywhere, any time.
If you have other questions regarding this product, please contact KETO-
CHECK at 800.513.1965 (10am - 4pm PST) or place of purchase.
Intended Use
The keto-mojo -ketone & blood glucose monitoring system is
intended for the quantitative measurement of glucose in fresh capillary
whole blood from the finger, and for the quantitative measurement of
-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from
the finger. The system is intended for in vitro diagnostic use and
for single-patient use as an aid to monitoring the effectiveness of a
diabetes control program. The system should not be used for the
diagnosis of or screening for diabetes, nor for use on neonates.
The test for haematocrit (HCT) as part of the system, is intended
for use in the in vitro quantification of packed red blood cell volume
fraction in capillary whole blood as an aid in monitoring the status of
total volume of red blood cells. The test reading of haematocrit (HCT)
is used only to determine whether the blood test sample is within the
acceptable range of -ketone & blood glucose monitoring system
monitoring system.It should not be used for the diagnosis of anaemia
or erythrocytosis.
Version 1.0 2017/07 311-4279300-014
4
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. Do NOT use the equipment in places where aerosol sprays are being
used, or where oxygen is being administered.
5. Do NOT under any circumstances use the device on neonates or
infants.
6. This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only.
7. Before using this device, read all instructions thoroughly and practice
the test. Carry out all the quality control checks as directed.
8. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets
and vial caps are choking hazards.
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.
For more information, please visit
1. "FDA Public Health Notification: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial
Communication" (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.
htm
2. "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
5
9. Do not use this instrument in close proximity to sources of strong
electromagnetic radiation, as this may interfere with the accurate
operation.
10. Proper maintenance and periodically control solution test are essential
to the longevity of your device. If you are concerned about your
accuracy of measurement, please contact your local customer service
or place of purchase for help.
6
BEFORE YOU BEGIN
10

Important Information
10

Test Principle
11

Contents of System
11

Meter Overview
12

Display Screen
13

Test Strip
13
SETTING THE METER
14
THE MEASURING MODES
15

For Blood Glucose Testing
15

For -ketone Testing
15
QUALITY CONTROL TESTING
16
When Should the Control Solution Test be Performed?
16
Performing a Control Solution Test
16
TESTING WITH BLOOD SAMPLE
18

Preparing the Lancing Device for Blood Testing
18

Performing a Blood Glucose or -Ketone Test
19

Alternative Site Testing (for -Ketone Test)
22
METER MEMORY
23

Reviewing Test Results
23

Reviewing Blood Glucose Day Average Results
23
DOWNLOADING RESULTS ONTO A COMPUTER
24
MAINTENANCE
25

Battery
25

Caring for Your Meter
26

Disinfecting Procedures
27

Caring for Your Test Strips
28

Important Control Solution Information
29
TABLE OF CONTENTS
7
SYSTEM TROUBLESHOOTING
30

Result Readings (for glucose test)
30

Result Readings (for -ketone test)
30

Error Messages
32

Troubleshooting
33
DETAILED INFORMATION
34

Reference Values
34

Comparing Meter and Laboratory Results
35
SYMBOL INFORMATION
36
SPECIFICATIONS
37
8
(e)
(f)
(d)
(g)
(h)
(i)
(a)
(b)
(c)
SET
9
(k)
(j)
(l)
(n)
(m)
1
2
10
BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional immediately.
If your blood glucose or -ketone results are lower or higher than
usual, and you do not have any symptoms of illness, first repeat the

test. If you have symptoms or continue to get results which are
higher or lower than usual, follow the treatment advice of your

healthcare professional.
Use only fresh whole blood samples to test your blood glucose or
-ketone. Using other substances will lead to incorrect results.
If you are experiencing symptoms that are inconsistent with your
blood glucose or -ketone test results and you have followed all the

instructions given in this owner's manual, contact your healthcare
professional.
The device should not be used on severely hypotensive individuals
or patients in shock. Readings which are lower than actual
values may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Please consult the
healthcare professional before use.
Limitation
The device should not be used on individuals in hyperglycemic-
hyperosmolar state, with or without ketosis; not for neonatal use;
not for use on critically ill patients.
11
Test Principle
Contents of System
Your system measures the amount of sugar (glucose) or -ketone in whole
blood. The glucose or -ketone testing is based on the measurement of
electrical current generated by the reaction of glucose or -ketone with the
reagent of the strip. The meter measures the current, calculates the blood
glucose or -ketone level, and displays the result. The strength of the current
produced by the reaction depends on the amount of glucose or -ketone in
the blood sample.
Your new keto-mojo -ketone & blood glucose monitoring system kit
includes:
1. Meter
2. Owner's Manual
3. Quick Start User Guide
4. 2 x 1.5 V AAA alkaline batteries
Test strips (c), control solutions (d), sterile lancets (f) or lancing device (e) are
not included in the kit. They must be purchased separately. Please make
sure you have those items needed for a test beforehand.
The strip port cable is not provided in the kit but an accessory for the data
transmission feature connecting to your personal computer (see section
Downloading Results onto your Computer). Please contact KETO-CHECK
at 800.513.1965 (10am - 4pm PST) or place of purchase.
NOTE:
If any items are missing from your kit or opened prior to use, please contact
local customer services or place of purchase for assistance.
12
SET
Meter Overview
Front
Top
Right Side
Left Side
Back
1
2
5
6
4
3
Test Strip Slot / Strip Communication Port
Insert test strip here to turn the meter on for testing.
Download test results with a strip port connection cable.
Display Screen
Main Button (M)
Enter the meter memory and silence a reminder alarm.
Test Strip Ejector
Eject the used strip by pushing up this button.
SET Button (S)
Enter and confirm the meter settings.
Battery Compartment
1
2
3
5
4
6
13
Display Screen
Ketone Symbol / Ketone Warning
Glucose Level / Ketone Level
Error Warning
Low Battery Symbol
Day Average
Memory Symbol
Hb Level / Time / Date
Hb Unit
HCT Level
Glucose / Ketone Measurement
Unit
Measurement Modes
Gen any time of day
AC before meal
PC after meal
1
2
3
4
5
6
7
9
8
10
Test Strip Symbol
Blood Drop Symbol
Code
Glucose Symbol
Alarm Reminder
13
12
14
15
16
11
14
13 12
1
15
3
7
2
4
5
6
8
11
ATTENTION:
The front side of test strip should
face up when inserting test strip.
Test results may be wrong if the contact
bar is not fully inserted into the test slot.
NOTE:
The TD-4279 keto-mojo -Ketone & Blood Glucose Monitoring System
should only be used with TD-4279 keto-mojo Glucose or -Ketone Test
Strips. Using other test strips with this monitoring system can produce
inaccurate results.
Test Strip
Absorbent Hole
Confirmation Window
1
2
Test Strip Handle
Contact Bars
3
4
9
(for glucose test)
(for ketone test)
1
3
4
2
10
16
14
SETTING THE METER
Before using your meter for the first time, you should check and
update these settings.
Entering the Setting Mode (a)
Start with the meter off (no test strip inserted). Press S.
1. Setting the date
The sequence of the date setting is: YEAR MONTH DAY. With
the YEAR / MONTH / DAY flashing in sequence, press M until the
correct year/month/day appears. Press S.
2. Setting the time format
Press M to select the desired time format --- 12h or 24h. Press S.
3. Setting the time
With the HOUR / MINUTE flashing in sequence, press M until the
correct hour/minute appears. Press S.
4. Setting the unit of measurement
Press M to switch between mg/dL and mmol/L. Press S.
5. Setting the buzzer
With the buzzer displays, press M to switch between "On" and "OFF".
Press S.
6. Deleting the memory
With "dEL" and a "
" on the display, press M and select "no" to
keep the results in memory then press S to skip. To delete all the
results, press M and select "yes" to delete all the memory records.
7. Setting the reminder alarm
Your meter has four reminder alarms. The meter will display "OFF"
and "AL1 ". If you don't want to set an alarm, press S to skip this step;
Or press M to select "On", then press S.
15
THE MEASURING MODES
For Blood Glucose Testing
The meter provides you with three modes for measuring, Gen, AC
and PC. You can switch between each mode by:
1. Start with the meter switched off. Insert a test strip to turn on the
meter. The screen will display a flashing " " and "Gen".
2. Press M to switch between Gen, AC and PC mode.
For -Ketone Testing
The meter provides you with one mode for measuring, Gen. You can
start with the meter switched off. Insert a test strip to turn on the
meter. The screen will display a flashing " " and "Gen".
Congratulations! You have completed all settings!
NOTE:
These parameters can ONLY be changed in the setting mode.
If the meter is idle for 3 minutes during the setting mode, it will switch

off automatically.
With the hour/minute flashing in sequence, press M to select the
correct hour/minute. Press S and go to the next alarm setting.
NOTICE:
When the alarm beeps, press M to switch it off. Otherwise, it will
beep for 2 minutes then switch off.
8. Setting the backlight
The default setting for meter backlight ("BL") is set to ON. Press M to
switch between "On" and "OFF".Press S.
16
NOTICE:
Your device will tag this measurement as QC test automatically.
To avoid contaminating the control solution, do not directly apply
control solution onto a strip.
QUALITY CONTROL TESTING
When Should the Control Solution Test be
Performed?
if it is mandatory following the local regulations in your country,
if you suspect the meter or test strips are not working properly,
if your test results are not consistent with how you feel, or if you
think the results are not accurate,
to practice the testing process, or
if you have dropped or think you may have damaged the meter.
Test strips (c), control solutions (d), lancing device (e) or sterile
lancets (f) may not be included in the kit (please check the contents
on your product box). They can be purchased separately. Please
make sure you have those items needed for a test beforehand.
Performing a Control Solution Test
To perform a control solution test, you will need: (b), (c) and (d).
1. Insert the test strip to turn on your meter
Wait for the meter to display "
" and " ".
2. Apply control solution (g)
Shake the control solution vial thoroughly before use. Squeeze out
the first drop and wipe it off, then squeeze out another drop and place
it on the tip of the vial cap. Hold the meter to move the absorbent hole
of the test strip to touch the drop. Once the confirmation window fills
completely, the meter will begin counting down.
17
3. Read and compare the result
After counting down to 0, the control solution test result will appear
on the display. Compare this result with the range printed on your test
strip vial and it should fall within this range. If not, please read the
instructions again and repeat the control solution test.
With "QC" displayed, the meter will store your test result in memory
under "QC".
Out-of-range results
If you continue to have test results fall outside the range printed on
the test strip vial, the meter and strips may not be working properly.
Do NOT test your blood. Call KETO-CHECK at 800.513.1965 (10am
- 4pm PST) for help.
NOTE:
There is no HCT and Hb display function while the meter is in QC mode.
The control solution range printed on the test strip vial is for control solution
use only. It is not a recommended range for your blood glucose or ketone
level.
See the MAINTENANCE section for important information about your

control solution.
18
WARNING:
To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet. Lancets are for single use only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the

lancing device.
Wash and dry your hands thoroughly after handling the meter, lancing
device and test strips to prevent infection. For more information, please
refer to the "Cleaning and Disinfection" section.
If the meter is being operated by a second person who is providing
testing assistance to the user, the meter and lancing device should be
decontaminated prior to use by the second person.
Sharing the lancing device and lancets may increase the risk of
contracting infectious diseases. Lancing device must not be used for
more than one person.
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood
extraction significantly reduces variations between measurements.
Please follow the suggestions below before obtaining a drop of
blood:
Select the puncture site at fingertips (for glucose test).
Select the puncture site either at fingertips or palm (please see
section 'Alternative Site Testing' [AST]).
Rub the puncture site for about 20 seconds before penetration.
Clean the puncture site using cotton moistened with 70% alcohol
and let it air dry.
Preparing the Lancing Device for Blood Testing
Please follow the instructions in the lancing device insert for collecting
a blood sample.
TESTING WITH BLOOD SAMPLE
19
Use a clear cap (optional) while setting up the lancing device (for
-ketone test).
Fingertip testing (l)
Press the lancing device's tip firmly against the lower side of your

fingertip. Press the release button to prick your finger; a click

indicates that the puncture is complete.
Blood from site other than the fingertip (m) (for -ketone test)
Replace the lancing device cap with the clear cap for AST. Pull the
cocking control back until it clicks. When lancing the palm, avoid

lancing the areas with obvious veins because of excessive bleeding.
NOTE:
Choose a different spot each time you test. Repeated punctures at the

same spot may cause soreness and calluses.
Please consult your health care professional before you begin AST (for

-ketone test).
It is recommended that you discard the first drop of blood as it may

contain tissue fluid, which may affect the test result.
Performing a Blood Glucose or -Ketone Test
To perform a blood glucose or -ketone test, you will need: (b), (c),
(e) and (f).
1. Insert the test strip to turn on the meter
Wait for the meter to display "
", " ", and "GLU" or "KETONE"
2. Select the appropriate measuring mode by pressing M
3. Obtaining a blood sample (h)
Use your pre-set lancing device to puncture the desired site. Wipe off
the first drop of blood with a clean cotton swab. The size of the drop
should be at least as big as (actual size), which is 1.0 microliter (L)
of volume. Gently squeeze the punctured area to obtain another drop
of blood. Be careful NOT to smear the blood sample.
20
NOTE:
Do not press the punctured site against your test strip or try to smear the
blood.
If you do not apply a blood sample to the test strip within 3 minutes, the
meter will automatically turn off. You must remove and reinsert the test strip
to start a new test.
The confirmation window should be filled with blood before the meter

begins to count down. NEVER try to add more blood to the test strip after

the drop of blood has moved away. Discard the used test strip and retest
with a new one.
If you have trouble filling the confirmation window, please contact your

health care professional or the local customer service for assistance.
5. Read your result
The result of your blood glucose test with HCT/ Hb levels or the result
of your -ketone test will appear after the meter counts down to 0.
The blood glucose result with HCT/ Hb levels or the -ketone result
will be stored in your memory automatically.
6. Eject the used test strip (j)
Eject your test strip by pushing the eject button on the side. Use a
sharps bin to dispose of used test strips. The meter will switch itself
off automatically.
Always follow the instructions in the lancing device insert when
removing the lancet.
4. Apply the sample (i)
Gently apply the drop of blood to the absorbent hole of the test strip
at a tilted angle. Confirmation window should be completely filled if
enough blood sample has been applied. Do NOT remove your finger
until you hear a beep sound.
21
WARNING:
The used lancet and test strip may be biohazardous. Please discard them
carefully according to your local regulations.
Wash your hands thoroughly with soap and water after handling the meter,
lancing device and test strips to avoid contamination. For more
information, please refer to the "Cleaning and Disinfection" section.
22
Alternative Site Testing (for -Ketone Test)
In addition to using your fingertips, you can test on your palms.
Important:
There are limitations with AST
(Alternative Site Testing).
Please consult your health care
professional before you
perform AST.
Suggested Test Areas
for the Hand
When to use AST?
Food, medication, illness, stress and exercise can affect ketone
levels. Capillary blood at the fingertip reflects these changes faster
than capillary blood at other sites. Thus, when testing ketone during
or immediately after a meal, physical exercise, or any other event,
take a blood sample from your finger only.
We strongly recommend that you perform AST ONLY at the following
times:
In a pre-meal or fasting state (more than 2 hours since the last
meal).
Two hours or more after taking insulin.
Two hours or more after exercise.
Do NOT use AST if:
You think your ketone is low.
Your AST results do not match the way you feel.
Your routine ketone results often fluctuate.
23
METER MEMORY
This meter stores the 1000 most recent blood glucose test results
along with respective HCT/Hb values, dates and times or -ketone
test results along with respective dates and times in its memory. To
enter the meter memory, start with the meter switched off.
Reviewing Test Results
1. Press and release M.
"
" will appear on the display. Press M again, and the first reading
you see is the last blood glucose result along with HCT/Hb value,
date, time and the measuring mode or you will see the last -ketone
result along with date, time and the measuring mode.
2. Press M to recall the test results stored in the meter. After the last
glucose or -ketone test result, press M again and the meter will
switch off.
Reviewing Blood Glucose Day Average Results
1. Press and release M. When "
" appears on the display, keep
pressing M for 3 seconds until the flashing "
" appears. Release
M and then your 7-day average result measured in general mode will
appear on the display.
2. Press M to review 14-, 21-, 28-, 60- and 90- day average results
stored in each measuring mode in the order of Gen, AC, and then PC.
3. Exit the meter memory. Keep pressing the M and the meter will
switch off after displaying the last test result.
NOTE:
Any time you wish to exit the memory, keep pressing M for 5 seconds or

leave it without any action for 3 minutes. The meter will switch off

automatically.
Control solution results are NOT included in the day average.
24
DOWNLOADING RESULTS ONTO
A COMPUTER
Data Transmission Via Cable
You can use your meter with a strip port cable and the Healthcare
Software System to view test results with HCT/Hb levels on your
personal computer. To learn more about the Healthcare Software
System or to obtain a strip port cable separately, please contact the
local customer services or place of purchase for assistance.
1. Obtaining the required cable and installing the software
To download Healthcare Software System, please visit TaiDoc's
website: www.taidoc.com
2. Connecting to a personal computer
Connect the strip port cable to a USB port on your computer. With
the meter switched off, connect the other end of the strip port cable to
the strip communication port. "PC" will appear on the meter display,
indicating that the meter is in communication mode.
3. Data transmission
To transmit data, follow the instructions provided with the software.
Results will be transmitted with the date and time. Remove the cable
and the meter will automatically switch off.
WARNING:
While the meter is connecting to the PC, it will be unable to perform a blood
glucose or -ketone test.
25
MAINTENANCE
Battery
Your meter comes with two 1.5V AAA size alkaline batteries.
Low Battery Signal
The meter will display one of the messages below to alert you when
the meter power is getting low.
1. The "
" symbol appears along with display messages: The
meter is functional and the result remains accurate, but it is time to
change the batteries.
2. The "
" symbol appears with E-b and
: The power is not
enough to do a test. Please change the batteries immediately.
Replacing the Battery (k)
To replace the batteries, make sure the meter is turned off.
1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old batteries and replace with two 1.5V AAA size
alkaline batteries.
3. Close the battery cover. If the batteries are inserted correctly, you
will hear a "beep" afterwards.
NOTE:
Replacing the batteries does not affect the test results stored in the

memory.
As with all small batteries, these batteries should be kept away from

children. If swallowed, promptly seek medical assistance.
Batteries may leak chemicals if unused for a long time. Remove the

batteries if you are not going to use the device for an extended period (i.e.,
3 months or more).
Properly dispose of the batteries according to your local environmental

regulations.
26
Caring for Your Meter
To avoid the meter and test strips attracting dirt, dust or other
contaminants, please wash hands thoroughly with soap and water
before and after use.
Why the cleaning and disinfection should be performed
Cleaning and disinfection are different. Cleaning is the process of
removing dirt (e.g. food debris, grease, dust), while disinfection is the
process of killing germs (e.g. bacteria and viruses).
When to clean and disinfect the meter
Clean the meter when you see any dirt on it. You should disinfect the
meter at least once a week to prevent infection.
How to clean and disinfect the meter
The meter must be cleaned prior to the disinfection. Use one
disinfecting wipe to clean exposed surfaces of the meter thoroughly
and remove any visible dirt or blood or any other body fluid with the
wipe. Use a second wipe to disinfect the meter. Do NOT use organic
solvents to clean the meter.
We recommend for meter cleaning and disinfection you should use
the disinfecting wipes/towelettes from below. The following product
with isopropyl alcohol as the active ingredient has been shown to be
safe for use with the blood glucose plus -ketone monitoring system:
Micro-Kill+ (Micro-Kill Plus) by Medline (EPA Reg. No. 59894-
10-37549)
To obtain disinfecting wipes and other information, please contact
Medline at 1-800-MEDLINE (1-800-633-5463) or visit www.medline.
com. You can also purchase it at Amazon (www.amazon.com) or
Walmart (www.walmart.com).
27
Disinfecting Procedures
1. Wipe all meter's exterior surface display and buttons by three
passes vertically and three passes horizontally with a folded
disinfecting towelette. Hold the meter with the test strip slot pointing
down and wipe the area around the test slot but be careful not to
allow excess liquid to get inside. Keep meter wet with disinfection
solution contained in the wipe for a minimum of 2 minutes for
Micro-Kill+ wipes. (p)
2. Remove the wipe. Allow the meter surface to dry completely.
3. Discard the used wipes and never reuse them. Users should wash
hands thoroughly with soap and water after handling the meter,
lancing device, or test strips.
Improper system cleaning and disinfection may result in meter
malfunction. If you have a question, please contact local customer
service at 800.513.1965 for assistance.
This device has been validated to withstand up to 10950 cleaning
and disinfection cycles using the recommended disinfecting wipe/
towelette. The tested number of cycles is estimated by 10 cleaning
and disinfection cycles per day over 3 years. The meter should be
replaced after the validated number of cleaning and disinfection
cycles or the warranty period, whichever comes first.
Stop using the meter if you see any signs of deterioration. For
example:
Meter cannot be turned on
LCD display cracks or becomes cloudy
Buttons no longer function
Meter outer casing cracks
Data cannot be transmitted to pc
Color or paint/printing on housing is abnormal
28
Scratches or abrasions on meter are higher than acceptable
Please contact the customer service for a replacement meter if
any of the signs of deterioration are noticed.
NOTE:
Do NOT clean and disinfect the meter while performing tests.
If the meter is being operated by a second person, the meter and lancing
device should be decontaminated prior to use by the second person.
Do NOT allow cleaning and disinfecting solution to get in the test slot,
battery compartment, or strip-ejection button.
If you do get moisture in the test strip slot, wipe it away with a corner of
tissue.
Always dry the meter thoroughly before using it
Do not spray the meter directly with cleaning solutions especially those
containing water (i.e. soapy water), as this could cause the solution to
enter the case inside and damage the electronic components or circuitry
After removing a glucose test strip from its vial, immediately close
the vial cap tightly.
Touch the glucose and ketone test strips with clean and dry hands.
Use each test strip immediately after removing it from the vial.
Write the opening date on the vial label when you first opened it.
Discard remaining blood glucose or -ketone test strips after 6
months.
Caring for Your Test Strips
Storage conditions: 35.6F to 86F (2C to 30C) for both blood
glucose test strips and blood -Ketone test trips. Relative humidity
of both is between 10% ~ 85%. Do NOT freeze.
Store your blood glucose test strips in their original vial only. Do not

transfer to another container.
Store test strip packages in a cool dry place. Keep away from
direct sunlight and heat.
29
Do not use test strips beyond their expiry date. This may cause
inaccurate results.
Do not bend, cut, or alter a test strip in any way.
Keep the strip vial away from children since the cap and the test
strip may be a choking hazard. If swallowed, promptly see a doctor

for help.
For further information, please refer to the test strip package
insert.
Important Control Solution Information
Use only Our control solution with your meter.
Do not use the control solution beyond the expiry date or 3 months
after first opening. Write the opening date on the control solution
vial and discard the remaining solution after 3 months.
It is recommended that the control solution test be done at room

temperature 68F ~ 77F (20C ~ 25C). Make sure your control
solution, meter, and test strips are at this specified temperature


range before testing.
Shake the vial before use, discard the first drop of control solution,
and wipe off the dispenser tip to ensure a pure sample and an
accurate result.
Store the control solution tightly closed at temperatures between
35.6F ~ 86F (2C ~ 30C). Do NOT freeze.
30
SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or
error messages other than the ones below appear, please contact
your local customer service. Do not attempt to repair yourself and
never try to disassemble the meter under any circumstances.
Result Readings (for glucose test)
MESSAGE
WHAT IT MEANS
< 10 mg/dL (0.6 mmol/L)
240 mg/dL (13.3 mmol/L)
> 700 mg/dL (38.9 mmol/L)
Result Readings (for -ketone test)
MESSAGE
WHAT IT MEANS
< 0.1 mmol/L
0.1 to 8.0 mmol/L
> 8.0 mmol/L
31
How to interpret blood Ketone results
References
1. Schade DS, Eaton RP. Metabolic and clinical significance of
ketosis. Special Topics in Endocrinology and Metabolism 1982;4:1-
27.
2. 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;20:1347-52.
3. 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;26:343-8.
4. Ubukata E. Diurnal variation of blood -Ketone bodies in
insulin-dependent diabetes mellitus and noninsulindependent
diabetes mellitus patients: The relationship to serum C-peptide
immunoreactivity and free insulin. Ann Nutr Metab 1990;34:333-42.
5. 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;37:1470-77.
6. Hale PJ, Crase J, Nattrass M. Metabolic effects of bicarbonate in
the treatment of diabetic ketoacidosis. Br Med J 1984;289;1035-8.
Your Ketone reading
Interpretation
Below 0.6mmol/L
This is normal
Between 0.6 and 1.5
mmol/L
You may require medical assistance; contact your
Diabetes healthcare team for advice.
Above 1.5mmol/L
Risk of Diabetic ketoacidosis; call your Diabetes
healthcare team immediately.
32
Error Messages
MESSAGE
WHAT IT MEANS
WHAT TO DO
E-b
Appears when the batteries
are too low.
Replace the batteries
immediately.
E-2
Expired code chip.
Repeat the test with a new lot of
test strip.
E-U
Appears when a used test
strip is inserted.
Repeat with a new test strip.
E-t
Appears when ambient
temperature is above or
below system operation
range.
System operation range is
10C to 40C (50F to 104F).
Repeat the test after the meter
and test strip are in the above
temperature range.
E-0,
E-A,
E-E,
E-C
Problem with the meter.
Repeat the test with a new test
strip. If the meter still does not
work, please contact the local
customer service for assistance.
E-F
Appears when test strip is
removed while counting
down, and insufficient blood
volume. Or the HCT result
is above 75 %.
Review the instructions and
repeat test with a new strip.
If the problem persists, please
contact the local customer
service for help.
33
1. If the meter does not display a message after inserting a test strip:
POSSIBLE CAUSE
WHAT TO DO
Batteries exhausted.
Test strip inserted upside down or
incompletely.
Defective meter or test strips.
Replace the batteries.
Insert the test strip with contact bars
end first and facing up.
Please contact customer services.
2. If the test does not start after applying the sample:
POSSIBLE CAUSE
WHAT TO DO
Insufficient blood sample.
Defective test strip.
Sample applied after automatic
switch-off (3 minutes after last user
action).
Defective meter.
Repeat the test using a new test strip
with larger volume of blood sample.
Repeat the test with a new test strip.
Repeat the test with a new test strip.
Apply sample only when flashing " "
appears on the display.
Please contact customer services.
Troubleshooting
3. If the control solution testing result is out of range:
POSSIBLE CAUSE
WHAT TO DO
Error in performing the test.
Control solution vial was poorly
shaken.
Expired or contaminated control
solution.
Control solution that is too warm or
too cold.
Defective test strip.
Meter malfunction.
Improper working of meter and test
strip.
Read instructions thoroughly and
repeat the test again.
Shake the control solution vigorously
and repeat the test again.
Check the expiry date of the control
solution.
Control solution, meter, and test strips
should be at room temperature 68F
to 77F (20C to 25C) before testing.
Repeat the test with a new test strip.
Please contact customer services.
Please contact customer services.
34
The -Ketone test measures Beta-Hydroxybutyrate ( -OHB), the most
important of the three -Ketone bodies in the blood. Normally, levels of -OHB
are expected to be less than 0.6 mmol/L.
-OHB levels may increase if a person fasts, exercises vigorously or has
diabetes and becomes ill. If your -Ketone result is 0.0 mmol/L, repeat the
-Ketone test with new test strips. If the same message appears again or the
result does not reflect 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 -Ketone result is between 0.6
and 1.5 mmol/L, this may indicate development of a problem that could require
medical assistance. Follow your healthcare professional's instructions. If your
-Ketone result is higher than 1.5 mmol/L, contact your healthcare professional
promptly for advice and assistance. You may be at risk of developing diabetic
ketoacidosis (DKA).
Please consult your doctor to determine a target range that
works best for you.
DETAILED INFORMATION
Reference Values
Blood glucose plus -ketone monitoring plays an important role in
diabetes control. A long-term study showed that maintaining blood
glucose levels close to normal can reduce the risk of diabetes
complications by up to 60%*1. The results provided by this system
can help you and your healthcare professional monitor and adjust
your treatment plan to gain better control of your diabetes.
American Diabetes Association. Standards of medical care in diabetes- 2016;
39 (supp.1 Diabetes Care): S16.
35
Comparing Meter and Laboratory Results
The meter provides you with whole blood equivalent results. The
result you obtain from your meter may differ somewhat from your
laboratory result due to normal variation. Meter results may be
affected by factors and conditions that do not affect laboratory results
in the same way. To make an accurate comparison between meter
and laboratory results, follow the guidelines below.
Before going to the lab:
Perform a control solution test to make sure that the meter is
working properly.
Fast for at least eight hours before doing comparison tests, if
possible.
Take your meter with you to the lab.
While staying at the lab:
Make sure that the samples for both tests are taken and tested
within 15 minutes of each other.
Wash your hands before obtaining a blood sample.
Never use your meter with blood that has been collected in a gray-
top test tube.
Use fresh capillary or venous blood only.
You may still have a variation from the result because blood glucose
or -ketone levels can change significantly over short periods of time,
especially if you have recently eaten, exercised, taken medication
or experienced stress*2. In addition, if you have eaten recently, the
blood glucose level from a finger prick can be up to 70 mg/dL (3.9
mmol/L) higher than blood drawn from a vein (venous sample) used
for a lab test*3. Therefore, it is best to fast for eight hours before doing
comparison tests. Factors such as the amount of red blood cells in the
blood (a high or low hematocrit) or the loss of body fluid (dehydration)
may also cause a meter result to be different from a laboratory result.
36
SYMBOL INFORMATION
SYMBOL
REFERENT
In vitro diagnostic medical device
Consult instructions for use
Temperature limitation
Do not use if package is damaged
*2: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April,
49-51.
*3: Sacks, D.B.: "Carbohydrates. " Burtis, C.A., and Ashwood,
E.R.( ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B.
Saunders Company (1994), 959.
SPECIFICATIONS
Model No.: TD-4279
Dimension & Weight: 96 (L) x 61 (W) x 26 (H) mm, 67.2 g
Power Source: Two 1.5V AAA alkaline batteries
Display: LCD
Memory: 1000 measurement results with respective date and time
External Output: Strip port cable

Auto electrode insertion detection
Auto sample loading detection
Auto reaction time count-down
Auto switch-off after 3 minutes without action
Temperature Warning
Operating Condition:
50F ~ 104F (10C ~ 40C), 10% to 85% R.H. (non-condensing)
Meter Storage / Transportation Conditions:
-4F ~ 140F (-20C ~ 60C), below 95% R.H.
Glucose Test Strip Storage / Transportation Conditions:
35.6F to 86.0F (2C to 30C), 10% to 85% R.H. (non-condensing),
up to 21 months for un-opened vial
-Ketone Test Strip Storage / Transportation Conditions:
35.6F to 86.0F (2C to 30C), 10% to 85% R.H. (non-condensing),
up to 18 months for un-opened vial
Measurement Units:
Glucose: Either mg/dL or mmol/ (Default mg/dL)
-ketone: mmol/L
Measurement Range:
Glucose : 10 ~ 700 mg/dL (0.56 ~ 38.89 mmol/L)
-ketone: 0.1 ~ 8.0 mmol/LExpected service
life: 5 years
37
This device has been tested to meet the electrical and safety requirements of:
IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1, IEC/EN 61326-2-6.
38
For self-testing
Distributed by
KETO-CHECK, INC.
952 School St. Suite 212
Napa, CA 94559-2824
Tel: 800.513.1965 10am-4pm PST
Please contact your healthcare provider outside hours of operation.
TD-4279