Spirit Healthcare TEE2 User manual

5) Meter will count down from five-to-one (5-to-1) on the display. Test results, time,
and date will appear and automatically be stored in the meter's memory. Remove
used test strip from port. Meter will turn off after three (3) seconds.
TEST RESULTS
The TEE2 brand of Meters will display results between 1.1-33.3 mmol/L.
Normal Blood Glucose Results
The range of a normal fasting* blood glucose level for non-diabetic adults is
between 3.9-5.5 mmol/L. Two (2) hours after a meal, the range of a normal blood
glucose level for non-diabetic adults is less than 7.8 mmol/L.1
*Fasting is defined as no caloric intake for at least eight (8) hours.
Low Blood Glucose Results
If the test result is below 1.1 mmol/L, Lo will appear on the display indicating
hypoglycemia (low blood glucose). You should follow the appropriate treatment
recommendations of your healthcare professional.
High Blood Glucose Results
If the test result is above 33.3 mmol/L, HI will appear on the display to indicate
hyperglycemia (high blood glucose). If so, follow hyperglycemia treatment
recommendations of your healthcare professional.
Unexpected Results
Low or high blood glucose readings can indicate a potentially serious medical
condition. If your results are unusually low or high, or don’t match the way you feel,
repeat the test with a new test strip. If your reading is inconsistent with your
symptoms or your result is less than 3.3 mmol/L or higher than 13.3 mmol/L,
contact your healthcare professional.
Please note that:
• An abnormally high or low red blood cell count (hematocrit level over 55% or
below 30%) may produce inaccurate results.
• Severe dehydration (excessive water loss) may cause inaccurate results. If you
believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
• Altitude of up to 3,000m (10,000 ft) above sea level has no effect on the
performance of the test strip.
• Interferences: Acetaminophen, ascorbic acid (vitamin C), uric acid 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 inaccurate high results.
• Blood samples that contain a high concentration of dissolved oxygen may lower
the test result.
• Discard used test strips properly in an appropriate container.
METER AND TEST STRIP PERFORMANCE CHECK
The TEE2 Control Solution (Control A and/or B) contains a known amount of
glucose that reacts with the TEE2 Test Strip in combination with the TEE2 Brand of
Meters to make sure they are working properly together and the correct testing
procedure is being followed.
You may run a check when you:
• Want to practice the test procedure using the control solution instead of blood.
• Use the meter for the first time.
• Open a new vial of test strips.
• Have symptoms that are inconsistent with your blood glucose test results.
• Believe your test results are not accurate.
• Suspect your meter and test strips are not performing properly.
• Drop or damage the meter.
If your control solution test results do not fall within the range printed on the test
strip vial, repeat the test. Out of range results may be due to one or more of the
following factors:
• Error in performing the test.
• Expired or contaminated control solution.
• Expired or damaged test strip.
• Failure to shake control solution bottle.
• Failure to discard first drop of control solution and wipe bottle tip clean.
If results continue to fall outside the range printed on the vial, the Test Strip and
Meter may not be working properly. If so, do not use your system and contact your
authorised i-SENS sales representative.
CHEMICAL COMPOSITION
Each TEE2 Test Strip contains the following reagents:
Glucose oxidase(Aspergillus sp.): 2.7 units
Hexaamineruthenium(III) chloride: 45.7 μg
Other ingredients: 1.6 μg
PERFORMANCE CHARACTERISTICS
The performance of TEE2 Brand of BGM Systems has been evaluated in laboratory
and clinical tests.
TEE2 Blood Glucose Test Strips
IMPORTANT
Please read this information and the TEE2 brand of blood Glucose Meters
Owner's Booklet before using TEE2 Test Strips.
PGC8E2012 REVx 07/2017
WARNINGS AND PRECAUTIONS
• Inaccurate results may occur in patients undergoing oxygen therapy.
• Keep test strips and the test strip vial away from children. The test strips and
vial cap may be choking hazards. Drying agents in the vial cap may be harmful
if inhaled, swallowed, or may cause skin or eye irritation.
• Test strips are for single use only. Do not reuse.
• If test strip does not absorb the blood sample properly, please contact your
authorised i-SENS sales representative.
CAUTION
Alternative site and fingertip results may differ significantly due to rapid changes
in the glucose level after meals or exercise, hypoglycemic symptoms, or effects
of drugs such as insulin. Use a fingertip sample site if you suffer from
hypoglycemia or have experienced hypoglycemic shock or symptoms.
For instructions on how to obtain samples from alternative sites, please refer to
the Alternative Site Testing(AST) section of the Owner's Booklet of your meter.
INTENDED USE AND TEST PRINCIPLE
TEE2 Blood Glucose Test Strips work with the TEE2 brand of Blood Glucose
Meters to quantitatively measure glucose in whole blood. The TEE2 brand of Blood
Glucose Monitoring system is for self-testing outside the body (in vitro diagnostic
use). The TEE2 brand of Blood Glucose Monitoring System should not be used for
the diagnosis of diabetes or for testing newborns. Glucose in blood samples react
with the chemical in the test strip to produce a small electrical current. The TEE2
brand of Blood Glucose Meter detects the electrical current which reflects the amount
of glucose in the blood sample.
STORAGE AND HANDLING
• Store vial in a cool and dry place between 1-30˚C (34-86˚F). Do not freeze.
• Keep the vial of test strips away from direct sunlight or heat.
• Store unused test strips in their original vial to avoid damage or contamination.
• Push the lid down on the vial immediately after taking out a test strip to fully close
the vial and maintain air tightness.
• Handle test strips only with clean and dry hands.
• Use the test strip immediately after taking it out of the vial.
• Do not bend, cut, or alter the test strips in any way.
• Do not force a test strip into the meter. Gently push it into the meter’s test strip port.
• Apply only fresh capillary whole blood for testing.
• Use all of the test strips within the expiration date printed on the test strip box and
vial label.
• Dispose of test strips past the expiration date immediately. Using test strips past
their expiration date can produce incorrect test results.
• Test strips in new, unopened vials and test strips in vials that have been opened can
be used up until the expiration date printed on the test strip box and vial label if the
test strips are used according to its storage and handling methods.
BLOOD SAMPLE COLLECTION PROCEDURE
Wash hands and sample site with soap and warm water. Rinse and dry thoroughly
before beginning blood sample collecting with a lancing device.
Fingertip Site Blood Sampling
Unscrew the lancing device tip. Place the loaded lancing device against the side of
the fingertip and press the release button. Massage the fingertip to obtain a round
drop (at least 0.5 µL, actual size: ) of blood. Apply test strip tip to the blood sample.
Alternative Site Blood Sampling
Select a clean, soft and fleshy sample site area free of visible veins, hair, and away
from bones. Gently massage the sample site to help blood circulation to minimise
result differences between fingertip and alternative site sampling. Firmly press and
hold the lancing device against sample site. Wait until the skin surface under the
lancing device changes color. Then press the release button while continuing to apply
pressure. Keep holding the lancing device against your skin until sufficient (at least
0.5 µL, actual size: ) amount of blood is drawn. Carefully lift the lancing device
away from your skin.
TEST PROCEDURE
1) Wash hands and sample site with soap and warm water. Rinse and dry thoroughly.
2) Insert test strip with contact bars facing up into the port. Push in strip gently until
meter beeps.
3) Then the or symbol will appear.
4) Use lancing device to get blood sample. Sample must be at least 0.5 µL (actual
size: ) to fill the test strip confirmation window. When the or
symbol appears on display, apply blood sample to edge of the narrow end of the
test strip until the meter beeps. If confirmation window is not filled completely, an
Er4 message may appear.

TEE2 Blood Glucose Test Strips
© 2017 i-SENS, Inc. All Rights Reserved.
i-SENS, Inc. 43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH, Altenhofstrasse 80,
D-66386 St. Ingbert, Germany
• No part of this document may be reproduced in any form or by any means without the
prior written consent of i-SENS.
• The information in this manual is correct at the time of printing. However, i-SENS
reserves the right to make any necessary changes at any time without notice as our
policy is one of continuous improvement.
ACCURACY
The TEE2 Brand of BGM system is calibrated to yield results equivalent to plasma
glucose concentrations. The accuracy of the TEE2 Brand of BGM
Systems was
evaluated by comparing blood glucose results obtained
by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument. The
following results were obtained by diabetic patients at clinic centers.
Slope 0.9805
Y-intercept 0.01 mmol/L
Correlation coefficient (r)
0.995
Number of sample 100
Range tested 1.3-26.2 mmol/L
Accuracy results for glucose concentration < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
86/162 (53.1%) 143/162 (88.3%) 162/162 (100%)
Accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10% Within ± 15%
265/438 (60.5%) 395/438 (90.2%) 436/438 (99.5%)
DESCRIPTION OF SYMBOLS
Consult instructions for use
Temperature limitation
In vitro diagnostic medical device
Manufacturer
Authorised representative
CE mark reg. IVDD 98/79/EC
Batch code
Use by (unopened or opened test strip vial)
Cautions for safety and optimum product use
Do not reuse
Reference
1. American Diabetes Association. “Standards of Medical Care in Diabetes – 2016.”
Diabetes Care. January 2016; 39(1):S15, S100.
PRECISION
The precision studies were performed in a laboratory using the TEE2 BGM System.
Within Run Precision
Blood avg. 2.4 mmol/L SD = 0.1 mmol/L
Blood avg. 3.9 mmol/L SD = 0.2 mmol/L
Blood avg. 7.4 mmol/L CV = 3.5%
Blood avg. 11.3 mmol/L CV = 2.6%
Blood avg. 19.0 mmol/L CV = 3.2%
Between Run Precision
Control avg. 2.1 mmol/L SD = 0.1 mmol/L
Control avg. 6.2 mmol/L CV = 2.9%
Control avg. 20.1 mmol/L CV = 3.2%
This study shows that there could be variation of up to 3.5%.
Spirit Healthcare Ltd.
Spirit House
Saffron Way, Off Saffron Lane,
Leicester, LE2 6UP
Customer Support Tel :
0800 881 5423