Keto-mojo TD-4279 User Manual

ver 1.0 2017/07
312-4279301-014

TD-4279

β-Ketone Test Strip

Warnings

► For in vitro diagnostic use (for use outside of the body only).
► For single use only.
► 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.

► Please read this sheet and your TD-4279 keto-mojo β-Ketone & Blood Glucose Monitoring System

Owner's Manual before you use this test strip. Use only TD-4279 keto-mojo β-Ketone Test Strip with
TD-4279 keto-mojo β-Ketone & Blood Glucose Monitoring System to obtain accurate results, and be
covered by the manufacturer’s warranty.

► This system is not for use in patient with abnormally low blood pressure, or those who are in shock, as

well as in hyperglycemic-hyperosmolar state, with or without ketosis.

► This system should not be used on critically ill patients, or patients with impaired peripheral circulation,

severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic
coma or shock.

► Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for

advice.

Intended Use

TD-4279 keto-mojo β-Ketone Test Strip, when use together with the keto-mojo β-Ketone & Blood Glucose

Monitoring System, allows your β-Ketone levels to be measured by yourself at home. It uses fresh whole

blood samples from the finger. This system is intended for single-patient use (lay-users at home) and should
not be shared. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

About Alternative Site Testing (AST)

IMPORTANT: There are limitations for performing AST. Please read the β-ketone & blood glucose monitoring
system Owner’s Manual and consult your doctor before you perform AST.

Alternative site testing (AST) is when individuals check their β-Ketone levels using areas of the body
other than the fingertip. The β-ketone & blood glucose monitoring system allows AST to be performed on a
site other than the fingertip - namely the palm.

Do NOT use AST if:

■ You think your β-Ketone is low.

■ Your AST results are inconsistent with the way you feel.

■ Your routine β-Ketone results often fluctuate.

To obtain a blood sample from the alternative site, please rub the puncture site for approximately 20
seconds before following the procedures of “Testing Your β-Ketone”.

Limitations

► Haematocrit: The haematocrit level is limited to between 10% and 70%. Please ask your healthcare

professional if you do not know your haematocrit level.
► Neonatal Use: This test strip must not be used for the testing of newborns.
► Altitude Effects: Altitudes up to 10,742 feet (3,275m) do not affect test results.

Storage and Handling

IMPORTANT: Do not use the test strips if they have expired.

► Test strips expire 6 months after first opening. Write the first opening date on the test strip vial when you

first opened it. (For strip vial only)
► Store the test strips in a cool, dry place between 35.6°F and 86°F (2°C and 30°C) and 10% to 85%

relative humidity.
► Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.

► Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other containers.

(For strip vial only)
► Do not touch the test strips with wet hands.
► Use each test strip immediately after taking it out of the vial or individual foil packet. Close the vial

immediately after taking out a strip. (For strip vial only)
► Keep the vial closed at all times. (For strip vial only)
► Do not bend, cut, or alter the test strip.

Strip Appearance

1

1. Absorbent Hole

Apply a drop of blood here.

2

The blood will be automatically absorbed.

2. Confirmation Window

This is where you confirm if enough blood has been
applied to the absorbent hole in the strip.

3

3. Test Strip Handle

Hold this part to insert the test strip into the slot.

4

4. Contact Bars

ATTENTION

Insert this end of the test strip into your meter.
Push it in firmly until it will go no further.

The front side of the test strip should face up when inserting the test strip.

Test results may be wrong if the contact bar is not fully inserted into the test slot.

Code Chip Instructions

The code chip is applied to calibrate the meter and set a reminder that the test strip will be expired in 30 days.

Operation

You must insert the code chip to code the meter and renew the strip’s expiry date
whenever you begin to use a new box of test strips.

1. Insert the code chip when the monitor is off. Wait until the number appears on
the display.

2. Remove the code chip. The display will show “OFF”, and then meter will switch off.
This means that the meter has been updated to the new expiry date and is
ready for measurement.

Checking the Number

You need to make sure that the number displayed on the meter matches the number on your test strip vial
before you proceed. If it matches, you can proceed with your test. If the numbers do not match, please stop
testing and insert the correct code chip. If the problem persists, contact Customer Service for help.

NOTICE:

■ The number on the display is only for your reference.

■ The expiry date reminder will be activated and an
error message will appear if the test strip is expired.
The numbers shows in the center means that the day
counts down from 30 to 01. Please be reminded to use
the remaining test strips within 30 days to get accurate
results. If the error message E-2 appears, it means that the test strip is expired. Repeat the test with a new
lot of test strip to get accurate result.

Code Chip

Testing Your β-Ketone

PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING.

STEP 1

Insert the test strip fully into the slot of your meter until it will go no further.
When the strip is fully inserted, the meter will do several self-checks.

STEP 2

Collect a blood sample for about 1.0 μL with the test strip. A sufficient
quantity of blood is required for the test to provide accurate results. Touch
the blood drop with the absorbent hole of the test strip, and wait until the
confirmation window is fully covered. Do NOT apply a smeared blood sample.
The meter will start counting down.

STEP 3

After few seconds, the meter will display your β-Ketone level. The last reading
will be automatically saved in the meter. Turn it off by removal and disposal of
the used test strip.

Please refer to your Owner’s Manual for further information.

Cleaning and disinfection of your meter are required to reduce the risk of bloodborne pathogen transmission.

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, blood, or any other body fluid with the wipe. Use a second
wipe to disinfect the meter by following the disinfecting procedure. Please refer to your Owner's Manual for
more information about the cleaning and disinfection procedures with a disinfecting wipe.

The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to

your local regulations.

Reading Your Result

The β-Ketone readings deliver plasma equivalent results and are displayed in millimoles of ketone per liter of

blood (mmol/L).

The β-Ketone test measures Beta-Hydroxybutyrate (ß -OHB), the most important of the three β-Ketone bodies

in the blood. Normally, levels of ß -OHB are expected to be less than 0.6 mmol/L.

ß -OHB levels may increase if a person fasts, exercises vigorously or has diabetes and becomes ill. If your

β-Ketone result is 0.0 mmol/L, repeat the β-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 β-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 β-Ketone result is higher than 1.5

mmol/L, contact your healthcare professional promptly for assistance. You may be at risk of developing

diabetic ketoacidosis (DKA)

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 β-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.

Please consult your doctor to determine a target range that works best for you.

1-6

.

Questionable or inconsistent results

If your test results are unusual or inconsistent with how you are feeling:

■ Make sure the confirmation window of your test strip is completely filled with blood.

■ Check the expiry date of your test strips.

■ Check the performance of your meter and test strip with the control solution.

PLEASE NOTE: Unusually high or low β-Ketone levels may be symptoms of a serious medical condition. If
most of your results are unusually high or low, please contact your healthcare professional.

Quality Control Testing

Our control solutions contain a known amount of β-Ketone that can react with test strips. Do a control
solution test in following conditions:

■ You first receive the meter

■ At least once a week to routinely check the meter and test strips

■ You begin using a new vial of test strips

■ You suspect the meter or test strips are not working properly

■ Practicing the testing process

■ You have dropped or think you may have damaged the meter

You can check the performance of meter, test strip and your technique by comparing the control solution
results with the range printed on the label of test strip vial. Checking regularly can ensure your test results are
accurate. If the quality control check fails, conduct the quality control check again or contact customer service
if the quality control check continues to fail. Please refer to the Owner's Manual for complete testing
instructions.

IMPORTANT: The reference range of the control solution may vary with each new vial or package of test strips.
Make sure you check the range on the label of your current vial or on the current package.

If the LCD displayed code is not the same as the code on your test strip vial or package, and the code
number cannot be updated, please contact Customer Service for assistance.

Chemical Components

> ß-Hydroxybutyrate Dehydrogenase (Pseudomonas sp.) ≧0.5 U
> Electron shuttle 35%
> Enzyme protector 10%
> Non-reactive ingredients 42%

Performance Characteristics

Always wear gloves and follow your facility’s biohazard control policy and procedures when performing tests
involving patient blood samples. Use fresh whole blood samples only. Professionals may use test strips to
test capillary and venous whole blood.
Sample Size: 1.0 μL
Reaction Time: 10 seconds
System Measurement Range: 0.1 mmol/L ~ 8 mmol/L
Haematocrit Range: 10% to 70%

Accuracy

TD-4279 keto-mojo β-ketone & blood glucose monitoring system was tested in the hand of 120 lay users
using capillary blood samples, covering the rage between 0.04 – 6.77 mmol/L. The results are compared
to the laboratory method and are shown below:

Table 1. Results for β-Ketone concentration <2 mmol/L

Within 0.3 mmol/L

80/89(89.9%)

Within 0.5 mmol/L

89/89(100%)

Table 2. Results for β-Ketone concentration ≧2 mmol/L

Within 5%

15/31 (48.4%)

Note: When results of TD-4279 keto-mojo are compared to the laboratory results, difference values below 2
mmol/L are expressed in mmol/L, while those above 2 mmol/L are compared in percentage.

Precision

Precision studies using control solutions (intermediate precision) and blood samples (repeatability) are
shown blow:

Within 10 %

25/31 (80.6%)

Within 15 %

30/31 (96.8%)

Within 20 %

30/31 (96.8%)

Within 25 %

31/31 (100%)

Table 3. Intermediate precision

Control solutions

Mean (mmol/L)

SD (mmol/L)

CV (%)

L1

0.584

L2

2.592

0.058 0.072

9.86% 2.78%

Table 4. Repeatability

Blood samples

Mean (mmol/L)

SD (mmol/L)

CV (%)

Level 1

0.513

Level 2

2.920

0.063 0.103

12.28% 3.53%

Level 3

4.997

0.177

3.54%

Symbol Information

Symbol Referent

in vitro diagnostic medical
device

Consult instructions for use

Temperature limitation

Do not reuse

Use Only With TD-4279 keto-mojo β-Ketone &

Blood Glucose Monitoring System.

35.6°F

86°F

For self-testing.

Symbol Referent

Keep away from sunlight

Keep dry

Do not use if package is
damaged

Distributed by KETO-CHECK, INC.

952 School St. Suite 212

Napa, CA 94559-2824

Tel: [phone]am-4pm PST

Please contact your healthcare provider outside hours

of operation.