Abbott FreeStyle Lite Instrukcja Użytkownika Pobierz pdf

FREESTYLE LITE® BLOOD GLUCOSE TEST STRIPS

FreeStyle Lite Blood Glucose Test Strips-Product Information

Only for use with FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Systems to Test for Glucose in Whole Blood

(Blood Glucose Test Strip with Coulometric Technology)

IMPORTANT: PLEASE READ THIS INFORMATION AND YOUR OWNER’S BOOKLET BEFORE

USING THE FREESTYLE LITE TEST STRIPS TO TEST YOUR BLOOD SUGAR.

For help call Customer Care at 1-888-522-5226, 24 hours a day, 7 days a week.

Intended Use

The FreeStyle Lite Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the

finger, upper arm and palm and venous whole blood for FreeStyle Lite, FreeStyle Freedom Lite Systems. It is intended for use by healthcare

professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not

intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Warnings

• Do not use during xylose absorption testing.

• Any change in medication based on FreeStyle Lite blood glucose test results without the consent and advice of a

physician or healthcare professional is not recommended.

• Product contains small components that might be considered 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.

• If you get FreeStyle 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 system 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.

• Do not fill the test strip from both the left and right sample areas during a single test. This may cause inaccurate test

results.

• Do not use test strips beyond the expiration date printed on the package since this may cause inaccurate results.

• Physiologic differences in the circulation between the finger, and other test sites like the upper arm and palm,

may result in differences in blood glucose measurements from the other test sites and your finger. Differences in

blood glucose measurements between the other test sites and your finger may be observed after eating, insulin

medication or exercise. Changes in blood glucose may be observed in finger blood samples sooner than blood samples

from alternate sites. Vigorous rubbing of the alternate test sites before lancing will help to minimize the difference

between finger and alternate site test results. If you are testing for hypoglycemia (low blood glucose), or if you suffer

from hypoglycemia unawareness, we recommend that you test on your fingers.

Important

• The device must not be used on more than one person including other family members due to the risk of spreading infection. All parts

of the device and its accessories are considered biohazardous and can potentially transmit infectious diseases, even after performing the

cleaning procedure.

1,2

• Healthcare professionals handling this system must always wear gloves and should follow the infection control policies and procedures

approved by their facility.

• If you choose to use a sample from the palm or upper arm consult your healthcare professional before you use any one of these sites to

monitor your blood glucose.

Precautions

• Ensure that the correct unit of measurement is displayed with each result. See Owner’s Booklet for further details.

• Severe dehydration or 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.

Storage and Handling

• Test strips must be discarded after the expiration date printed on the vial.

• After removing a test strip from the vial, replace the vial cap immediately and close it tightly. 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.

• Store at room temperature between 40°F to 86°F (4°C to 30°C). Use test strips only within the system operating temperature range as

outlined in your Owner’s Booklet.

• Avoid exposing test strips to extreme temperatures.

• Do not bend, cut, or alter a FreeStyle Lite 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.

Performing a Blood Glucose Test

Test Method

When the blood sample is applied to the test strip, the glucose in the blood reacts with the chemicals on the test strip, producing a small

electrical current. The meter measures the current over time, calculates the electrical charge, and converts it to a glucose value.

See your blood glucose meter Owner’s Booklet for a step-by-step guide on how to do the test.

1. Set Up

• Depending on your blood glucose monitoring system, it can be used to test on your finger, palm and upper arm.

• Wash your hands and the test site with warm water and soap to ensure accurate results. Thoroughly dry your hands and the test site. Do

not use lotion or cream on the test site. To bring fresh blood to the surface, rub the test site (except the finger) vigorously for a few seconds

until you feel it getting warm.

• Put a strip in the meter. Meter will turn on automatically.

2. Do the Test

• When the prompt to apply the sample appears on the screen, use your lancing device to obtain a blood sample.

• Gently touch one sample application area of the test strip to the blood sample. If the strip does not fill, reapply the sample to the same

area within 60 seconds. Do not apply the sample to both edges of the strip. Do not put the sample on top of the sample application area.

• When the strip is full, the meter will “beep” or you will see the moving lines on the display.

3. Read Results

• Read the test results on the meter display.

4. Wash your hands and test site thoroughly with warm water and soap after handling the meter, lancing device or test

strips.

What Do Your Results Mean?

• The expected glucose range for a non-diabetic, non-pregnant fasting adult is under 100 mg/dL.

• Two hours after meals, levels should be less than 140 mg/dL.

• Consult your healthcare professional to determine the range that is appropriate for you.

• Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low or

high, or if you do not feel the way your reading indicates, 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 or higher than 240 mg/dL you should contact your healthcare professional

and follow his or her treatment advice.

Limitations

The FreeStyle Lite blood glucose test strips give accurate results when the following limitations are observed:

1. The test strips are for single use only. Do not reuse test strips.

2. Use fresh, whole capillary blood from the site you have selected to test.

3. Clean the site with warm soapy water and dry thoroughly before testing.

4. There is no effect from altitude up to 10,000 feet (3,048 meters) above sea level.

5. Hematocrit range: 15% to 65%.

Additional Information for Healthcare Professionals:

1. A venous whole blood sample may also be used. Use venous blood within 30 minutes after drawing. Common anticoagulants

(lithium heparin, EDTA) may be used.

2. Cholesterol up to 500 mg/dL or triglycerides up to 3,000 mg/dL do not significantly affect test results. However, glucose values in

specimens beyond these levels, should be interpreted with caution.

3. In situations of decreased peripheral blood flow, capillary blood testing may not be appropriate as it may not represent the true

physiological state. Examples would include but are not limited to: severe dehydration caused by diabetic ketoacidosis or the

hyperosmolar non-ketotic state, hypotension, shock, or peripheral vascular disease.

2,3,4

Critically ill patients should not be tested with

home use blood glucose meters.

Checking the System

The control solution is used to check the performance of the meters, test strips, and your testing technique. The system is performing

correctly if the control solution test result falls within the specific control solution range listed on your FreeStyle Lite test strip vial.

Control Solution Ranges:

Low: 30 - 60 mg/dL

Normal: 76 - 114 mg/dL

High: 248 - 372 mg/dL

NOTE: A control solution test should be performed when using the meter for the rst time, opening a new vial of strips,

when you get a HI or LO result, your test results do not agree with how you feel or you want to conrm that your meter

and test strips are working properly. To obtain control solution, call Customer Care.

When a control solution test is done, you should get results within the expected range printed on the test strip vial. If control solution test

results fall outside this range, repeat the test. Results that fall outside the range may be caused by:

• error in performing the test

• expired or contaminated control solution

• test strip deterioration

• meter malfunction

WARNING: If you continue to get FreeStyle control solution test results that fall outside the range printed on the test

strip vial, the system may not be functioning 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. Contact Customer Care.

Performance Characteristics

The performance of these test strips has been tested both in laboratory and clinical studies. The testing range is 20 mg/dL to 500 mg/dL.

The FreeStyle Lite test strip is calibrated to display the equivalent of plasma glucose values to allow easy comparison of results with

laboratory methods.

Accuracy

Capillary blood glucose results obtained by lay users were compared with those obtained using the YSI Glucose Analyzer.

Summary of system accuracy for finger samples with YSI glucose results lower than 75 mg/dL.

Within

± 5 mg/dL

Within

± 10 mg/dL

Within

± 15 mg/dL

73% (8/11) 100% (11/11) 100% (11/11)

Summary of system accuracy for finger samples with YSI glucose results of 75 mg/dL or higher.

Within

± 5 %

Within

± 10 %

Within

± 15 %

Within

± 20 %

68% (115/168) 95% (160/168) 99% (166/168) 99% (167/168)

Summary of system accuracy for alternate site samples with YSI glucose results lower than 75 mg/dL.

Test Site

Within

± 5 mg/dL

Within

± 10 mg/dL

Within

± 15 mg/dL

Palm 1/5 (20%) 3/5 (60%) 5/5 (100%)

Upper Arm 0/1 (0%) 1/1 (100%) 1/1 (100%)

Summary of system accuracy for alternate site samples with YSI glucose results of 75 mg/dL or higher.

Test Site

Within

± 5%

Within

± 10%

Within

± 15%

Within

± 20%

Palm 32/69 (46%) 54/69 (78%) 65/69 (94%) 67/69 (97%)

Upper Arm 39/76 (51%) 60/76 (79%) 69/76 (91%) 72/76 (95%)

The regression statistics are derived from a plot of the lay user finger data versus YSI capillary data.

Slope 0.95

y-intercept 7.3 mg/dL

Correlation coefficient (R) 0.99

Number of samples tested 179

Range tested 38-375 mg/dL

Precision

Within-lot and within-vial precision of these test strips was measured with venous blood samples in the laboratory.

Within-Lot Precision

Average Glucose Concentration mg/dL 43.3 94.2 140.7 238.3 345.0

SD mg/dL 1.5 2.3 2.9 4.8 6.8

CV % 3.3 2.4 2.2 2.3 2.4

Within-Vial Precision

Average Glucose Concentration mg/dL 43.3 94.2 140.7 238.3 345.0

SD mg/dL 1.3 2.0 2.4 3.9 6.0

CV % 2.9 2.2 1.8 1.9 2.1

Variability in blood tests from strip to strip was 3.3% or less.

Chemical Composition

FAD Glucose Dehydrogenase (Aspergillus Oryzae) ≥ 1.0 Unit

Other ingredients (buffer, mediator, etc.) ≥ 0.01 mg

Reference

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

3 American Diabetes Association Clinical Practice Recommendations: Diagnosis and classification of diabetes mellitus. Diabetes Care 2005;28

(Suppl.1):S37-S42.

4 Atkins SH, Dasmahapatra A, Jaker MA, Chorost MI, Reddy S: Fingerstick glucose determination in shock. Ann Int Med 114: 1020-1024.

1991.

5 Sandler M, Low-Beer T: Misleading capillary glucose measurements. Practical Diabetes 7: 210. 1990.

6 Wickham NWR, Achar KN, Cove DH: Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes 3: 100. 1986.

Description of Symbols

Consult instructions for use

Temperature limitation

Manufacturer

Batch code

Use by

Do not reuse

in vitro diagnostic medical device

23278A

1 2

Podsumowanie treści

Strona 1

FREESTYLE LITE® BLOOD GLUCOSE TEST STRIPSFreeStyle Lite Blood Glucose Test Strips-Product Information Only for use with FreeStyle Lite and FreeStyle F

Strona 2

This product(s) and/or its use are protected by one or more of the following patents/ Este producto y su uso están protegidos por una o más de las sig

Więcej dokumentów dla Nie Abbott FreeStyle Lite

Aby wyświetlić dokument Abbott FreeStyle Lite Instrukcja Użytkownika

Abbott FreeStyle Lite Instrukcja Użytkownika (14 strony)

Komentarze do niniejszej Instrukcji

Brak uwag

Abbott FreeStyle Lite Instrukcja Użytkownika

Przeglądaj online lub pobierz Instrukcja Użytkownika dla Nie Abbott FreeStyle Lite. freestyle lite® blood glucose test strips Instrukcja obsługi

Podsumowanie treści

Więcej dokumentów dla Nie Abbott FreeStyle Lite

Komentarze do niniejszej Instrukcji