IMPORTANT: Please read this information and your TB100 user’s manual before
using TB100 Test Strips. Call Spengler Customer Service immediately if these
instructional materials or your meter results seem unclear.
Intended Use
The TB100 Blood Glucose Test Strips are used with the TB100 Blood Glucose
Meter for quantitatively measuring glucose (sugar) in whole blood obtained
from the fingertip, palm and forearm. The TB100 Blood Glucose Monitoring
System is intended for use in the home and in professional settings to monitor
blood glucose levels. The TB100 Test Strips are for testing outside the body (in
vitro diagnostic use).
Test Principle
On each test strip there is a test area containing reaction chemicals. When blood
is applied to this area, a chemical reaction takes place, then a transient electrical
current is formed. The blood glucose concentration is calculated based on the
electrical current detected by the meter, then the result is showed on the
display. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL
(33.3 mmol/L). The TB100 Test Strip is calibrated to display the equivalent of
plasma glucose values to allow easy comparison of results with laboratory
methods.
Precautions
˙
For in vitro diagnostic use (outside the body) only.
˙
Do not reuse test strips.
˙
Do not use test strips beyond the expiration date printed on the package since
this may cause inaccurate results.
˙
Discard the vial and any unused test strips 3 months after you first open it.
Constant exposure test strips to air may destroy chemicals in the test strip. This
damage can cause incorrect readings.
˙
The sample must only be applied to the tip of the test strip. Do not apply blood
or control solution to the top, left or right sides of the test strip. This may cause
inaccurate test results.
˙
Use only the TB100 Blood Glucose Meter with the TB100
Test Strips.
˙
Keep the test strip vial away from children. The cap is a choking hazard. The
cap or vial contains drying agents to protect the test strips. Drying agents may
be harmful if inhaled or swallowed and may cause skin or eye irritation.
˙
Any change in medication based on the TB100 blood glucose
test results without the consent and advice of a physician or healthcare
professional is not recommended. Consult your physician or healthcare
professional before making changes in your treatment plan based on
your blood glucose test results.
˙
Severe dehydration and excessive water loss may cause false low results. If you
believe you are suffering from severe dehydration, consult your physician
immediately.
˙
All devices contaminated with blood should be disposed of properly.
˙
If you get TB100 Control Solution test results that fall outside the
range printed on the test strip vial, repeat the test with a new test strip. If the
test result is still outside the range printed on the test strip vial, the TB100 may
not be working properly. DO NOT use the system to test your blood
until you get a control solution test result within the range printed on the test
strip vial label.
Storage and Handling
˙
Store at room temperature between 4-30
℃
(39-86
℉
). Do not refrigerate or
freeze. Avoid exposing test strips to extreme temperatures.
˙
Store away from direct sunlight and heat.
˙
Use each strip immediately after removing it from the vial.
˙
Store your test strips in their original vial only. The cap or vial contains drying
agents to protect the test strips. Do not transfer test strips to a new vial or any
other container.
˙
After removing a test strip from the vial, replace the vial cap immediately and
close it tightly.
˙
Do not bend, cut, or alter the Test Strip in any way.
˙
With clean, dry hands you may gently touch the test strip anywhere when
removing it from the vial or inserting it into the meter.
How to do the Test
See your User’s Manual for a step-by-step guide on how to do the test.
Warning
Alternate site testing (AST) should ONLY be used in the following intervals:
˙
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 blood glucose is low.
˙
You are unaware of hypoglycemia.
˙
Your AST results do not match the way you feel.
˙
You are testing for hyperglycemia.
˙
Your routine glucose results are often fluctuating.
˙
If you are pregnant.
All parts of the glucose monitoring system should be considered potentially
infectious and are capable of transmitting blood-borne pathogens between
each user. To assure that you are not placing yourself or other persons at risk,
always remember:
˙
The meter and lancing device are for single person use.
Do NOT share them with anyone including other family members! Do not use
on multiple persons!
˙
All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfection.
˙
Refer to your user’s manual section “Cleaning and Disinfection procedure” for
how to clean your meter and lancing device.
1.
2.
3.
What Does The Results Mean?
Normal Glucose Values
The normal fasting glucose range for a diabetic adult is 70 to 130 mg/dL (3.9 to
7.2 mmol/L). One to two hours after meals, normal glucose values should be less
than 180 mg/dL (10.0 mmol/L).1 For people with diabetes, consult your
physician or healthcare professional for the target glucose values that are right
for you.
Low Glucose Values
The TB100 Meter displays results between 20 and 600 mg/dL (1.1 and 33.3
mmol/L). If your test result is lower than 20, “Low” (LO) will appear on the meter
display. This indicates severe low blood sugar (hypoglycemia). You should
immediately treat low blood sugar as recommended by your healthcare
professional.
High Glucose Values
If your test result is above 600 mg/dL (33.3 mmol/L), “High” (HI) will appear on
the meter display screen. This indicates severe high blood sugar (hyperglyce-
mia). You should immediately treat high blood sugar as recommended by your
healthcare professional.
Unexpected Results
Low or high blood sugar readings can indicate a potentially serious medical
condition. If your blood sugar is unusually low or high, or if you do not feel the
way your results indicate, repeat the test with a new test strip.
If your reading is
not consistent with your symptoms or if your blood glucose result is less than 60
mg/dL (3.3 mmol/L) or higher than 240 mg/dL (13.3 mmol/L), you should contact
your healthcare professional and follow his or her treatment advice.
Limitations
The TB100 Blood Glucose Test Strips give accurate results when the following
limitations are observed:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Use only the TB100 Test Strip with the TB100 Meter.
Use only capillary whole blood from finger, palm and forearm. Do not use
plasma or serum.
Do not use neonate samples. TB100 Test Strips are not validated for and
should not be used for testing neonatal blood specimens.
The system is tested to accurately read the measurement of glucose in
whole blood within the range of 20 to 600mg/dL (1.1-33.3 mmol/L).
This system can be used up to an altitude of 7545 feet.
The test strips are for single use only. Do not reuse test strips.
TB100 Test Strip does not interfere with the hematocrit at a normal range
(35-55%) of blood glucose. High (above 55%) and low (below 35%)
hematocrit can cause false results. Patients with higher hematocrit values
(above 55%) will usually test lower whiles patients with lower hematocrit
values (below 35%) will test higher. Please ask your healthcare professional
if you do not know your Hematocrit level.
Acetaminophen, uric acid, ascorbic acid (vitamin C), and other reducing
substances when occurring in normal blood or normal therapeutic
concentrations do not significantly affect results. However, abnormally high
concentrations in blood may cause inaccurately high results. Lipemic
samples; Cholesterol up to 375 mg/dL or triglycerides up to 2,000 mg/dL do
not significantly affect test results. However, glucose values in specimens
beyond these levels, should be interpreted with caution.
Blood samples that contain a high concentration of dissolved oxygen may
lower the test result.
Antiglycolysis and anticoagulants in blood samples may affect the test
results.
Severe dehydration, diabetic ketoacidosis, hyperosmolar non-kitotic state,
hypotension, shock, or peripheral vascular disease.2,3,4 may cause
inaccurate results.
Critically ill patients should not be tested with home use blood glucose
monitors as it may lead to inaccurate results.
Select the Puncture Site to Obtain Blood
You may obtain a blood drop from the fingertip, palm, or forearm. If using the
forearm, choose a fleshy area away from bone, visible veins and hair. If using
the palm, choose a fleshy area on the palm below your thumb or pinky finger.
Select a spot with no visible veins and away from deep lines, which may cause
your blood sample to smear. Wash your hands and the puncture site with
warm, soapy water. Dry them thoroughly. If you use an alcohol swab, make
sure the skin is dry before lancing. To help you get a large enough drop of
blood, you may gently massage or apply warmth to the site to increase blood
flow. Press and hold the sampler against your fingertip, palm or forearm for a
few seconds, then press the release button.
Blood Glucose Testing
Insert a Test Strip to the meter. The meter will turn on. Use the Lancing Device
to obtain the right size blood drop. Refer to your Lancing Device User’s
Instruction for how to lance your finger, forearm and palm. Then obtain a
blood sample about the size of a pinhead. Gently touch only one edge of the
Test Strip to the blood sample. Do not press the edge of the strip against the
test site. When the strip is full of blood, the meter will “beep” or you will see
the test strip chamber area completely filled.
Read Results
Read the test results in an average of 5 seconds. The result will be stored in
the meter memory. Results are displayed as mg/dL (milligrams per deciliter of
blood) or mmol/L (millimoles per liter of blood) depending on the units you
chose when you set up your meter. To change the units displayed, see your
User’s Manual section “Setting Up the Meter.”
Wash hands thoroughly with soap and water after handling the meter,
lancing device, or test strips.
1
For Testing Glucose in Capillary Whole Blood
TB100 Test Strip Package Insert
