OneTouch Ultra Manual
OneTouch
Blodsukkermåler
Ultra
Læs nedenfor 📖 manual på dansk for OneTouch Ultra (2 sider) i kategorien Blodsukkermåler. Denne guide var nyttig for 2 personer og blev bedømt med 4.5 stjerner i gennemsnit af 2 brugere
Side 1/2
• Patients undergoing oxygen therapy may yield falsely low results.
• Test results may be falsely low if the patient is severely dehydrated, in
shock, or in a hyperosmolar state (with or without ketosis). Critically
ill patients should not be tested by blood glucose meters.
• Lipemic samples: Cholesterol levels up to 700 mg/dL (18.1 mmol/L) and
triglycerides up to 3000 mg/dL (33.9 mmol/L) do not affect the results.
Grossly lipemic patient samples have not been tested and are not
recommended for testing with the OneTouch
® Ultra® Family of Meters.
Test Principle
The OneTouch®
Ultra® Family of Meters and OneTouch Ping® Meter
Remote are plasma-calibrated to allow easy comparison of results with
laboratory methods. Glucose in the blood sample mixes with special
chemicals on the test strip and a small electrical current is produced.
This current is measured by the OneTouch® Ultra® Family of Meters and
OneTouch Ping® Meter Remote and displayed as your blood glucose
result. The strength of this current changes with the amount of glucose
in the blood sample.
Reagent Composition
Each test strip contains: Glucose oxidase ≥ 0.08 IU; (Aspergillus niger)
ferricyanide ≥ 22 µg; other ingredients (buer, etc.). The test strip vial
contains a drying agent.
Performance Characteristics
The performance of OneTouch® Ultra® Test Strips has been evaluated
both in laboratory and in clinical tests.3
Measurement Range: The measurement range of the OneTouch
®
Ultra® Family of Meters is 20 to 600 mg/dL (1.1–33.3 mmol/L).
System Accuracy: Diabetes experts have suggested that glucose
meters should agree within 15 mg/dL (0.83 mmol/L) of a laboratory
method when the glucose concentration is lower than 75 mg/dL
(4.2 mmol/L), and within 20% of a laboratory method when the glucose
concentration is 75 mg/dL (4.2 mmol/L) or higher. Samples from
100 diabetic patients at 1 clinical center were tested using both the
OneTouch® Ultra®2 System and the YSI Model 2300 Glucose Analyzer
(laboratory test).3
System Accuracy Results for Glucose Concentrations <75 mg/dL
(4.2 mmol/L)
System Accuracy Results for Glucose Concentrations 75 mg/dL ≥
(4.2 mmol/L)
System Accuracy Results across the entire Glucose Range
Therefore, 96.3% of the total results obtained with the OneTouch
®
Ultra
®
2
System achieved the goal suggested by the diabetes experts.
Regression Statistics: Samples were tested in duplicate on each of
3 test strip lots. Results indicate that the OneTouch® Ultra®2 System
compares well with a laboratory method.
Precision:
Within Run Precision (100 venous
blood tests per glucose level)
Results show that the greatest variability observed between test strips
when tested with blood is 2.5% or less.
Data generated using OneTouch® Ultra®
2 Meter. OneTouch® Ultra®2
is representative of the OneTouch® Ultra® Family of Meters and the
OneTouch Ping® Meter Remote.
1. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York:
Simon and Schuster (1995), p. 158.
2. American Diabetes Association, Position Statement, Diagnosis and
Classification of Diabetes Mellitus, Diabetes Care 31:S55-S60, 2008.
3. Data on file.
OneTouch Ping®
Meter Remote—contact Animas Customer Service at
1 877-937-7867, 24 hours a day, 7 days a week.
For assistance outside of these hours, please contact your healthcare
professional.
Description of Symbols
For a complete description of all symbols used, refer to the User Guide
that came with your system.
Covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862,
6,284,125, and 7,112,265. Use of these test strips and associated monitoring device is
protected under the following U.S. patents: 6,413,410, 6,733,655, 7,250,105. Purchase of
the associated monitoring device does not act to grant a use license under these patents.
Such a license is granted only when the associated monitoring device is used with
OneTouch
®
Ultra
®
Test Strips. No test strip supplier other than LifeScan, Inc. is
authorized to grant such a license. The accuracy of results generated with LifeScan
meters using test strips manufactured by anyone other than LifeScan has not been
evaluated by LifeScan.
Intended Use
OneTouch® Ultra® Test Strips are used with the OneTouch® Ultra® Family
of Meters and the OneTouch Ping® Meter Remote for quantitatively
measuring glucose in fresh capillary whole blood. The OneTouch®
Ultra®
Test Strips and associated meters are intended for use by people
with diabetes at home and health care professionals in the clinical
setting. OneTouch® Ultra® Test Strips and associated meters are for use
in fingertip, forearm, and palm testing.
Storage and Handling
• Store the test strip vial in a cool dry place below 86°F (30°C).
Do Not refrigerate. Keep away from direct sunlight and heat.
Exposure to temperatures and/or humidity outside the required
storage conditions may result in inaccurate readings.
• Store your test strips in their . To avoid damage or original vial only
contamination, transfer test strips to any other container.Do Not
• Do Not Only open open the test strip vial until you are ready to test.
vial when removing test strips.
• After removing a test strip from the vial, immediately close the vial lid
tightly. Use each test strip immediately after removing it from the vial.
• Do Not use test strips from any vial that is damaged or left open to air.
• Write the discard date (date opened plus 6 months) on the vial label
when you rst open it.
• use test strips beyond the expiration (printed on vial label) or Do Not
discard date, whichever comes rst.
• Avoid getting dirt, food, or liquids on the test strip. With clean, dry
hands, you may touch the test strip anywhere on its surface.
• Do Not bend, cut, or alter the test strip in any way.
• Test strips are for single use only. Never reuse a test strip that had
blood or control solution applied to it.
• Make sure your meter and test strips are about the same temperature
before you test.
• Apply only control solution or a blood sample to the test strip.
• After performing a test, return the used test strip to the vial.Do Not
• Used test strips may be considered biohazardous waste in your area.
Be sure to follow your health care professional’s recommendations or
your local regulations for proper disposal.
Blood Glucose Test Procedure
For instructions on performing a blood test (including blood sample
collection), refer to the User Guide that came with your system.
Test Results
Low Glucose Values
If your test result is below 20 mg/dL (1.1 mmol/L), a warning message
will appear indicating a low glucose level. This may indicate severe
hypoglycemia (low blood glucose). Treat this condition immediately,
according to your health care professional’s recommendations.
Although this message could be due to a test error, it is safer to treat
rst, and then do another test.
High Glucose Values
If your test result is above 600 mg/dL (33.3 mmol/L), a warning
message will appear indicating a high glucose level. This may indicate
severe hyperglycemia (high blood glucose). You should retest your
glucose level. If the message appears again, call your health care
professional immediately.
If You Get Unexpected Results
If your blood glucose result is below 70 mg/dL (3.9 mmol/L),
indicating low blood glucose, or above 180 mg/dL (10.0 mmol/L),
indicating high blood glucose, you should contact and follow your
health care professional’s treatment advice.1 If you continue to get
unexpected results, check your system with control solution. If you
are experiencing symptoms that are not consistent with your blood
glucose test results AND you have followed all instructions described
in your User Guide, call your health care professional. Never ignore
symptoms or make signicant changes to your diabetes control
program without speaking to your health care professional.
IMPORTANT:
Please read this information and your OneTouch
®
Ultra
®
Family of Meters and OneTouch Ping
®
Meter Remote User
Guide before using OneTouch
®
Ultra
®
Test Strips. Do Not use your
OneTouch
®
Ultra
®
Test Strips if your vial is open or damaged in any
way as this could lead to error messages or inaccurate blood glucose
values. Contact LifeScan Customer Service at 1 800 2278862
immediately if the test strip vial is open or damaged, or if these
instructional materials or your meter results seem unclear. (Contact us
7 days a week, 8 a.m. – 8 p.m. Eastern Time. For assistance outside of
these hours, please contact your healthcare professional.)
Range of Expected Values
Blood glucose management requires the help of a health care
professional. Together you can set your own range of expected blood
glucose values, arrange your testing times, and discuss the meaning of
your blood glucose results.
Expected blood glucose levels for people without diabetes:
2
Time Range, mg/dL Range, mmol/L
Fasting Less than 100 Less than 5.6
2 hours after meals Less than 140 Less than 7.8
Checking the System
Use OneTouch
® Ultra® Control Solutions
A control solution test is performed to check that the meter and test
strips are working together properly and that you are performing the
test correctly. For instructions on how and when to check the system
by performing a control solution test, refer to the User Guide that came
with your system.
Limitations of Procedure
OneTouch® Ultra® Test Strips give accurate results when the following
limitations are observed:
• use for the diagnosis of diabetes or for testing of newborns.Do Not
• Test strips are for single use only. reuse.Do Not
• The test strips are specific to D-glucose and do not react to other
sugars, which may be present in blood.
• Use only fresh capillary whole blood. use serum or plasma.Do Not
• Hematocrit is the percentage of red blood cells in the blood.
Extremes in hematocrit may affect test results.3 Hematocrit levels
below 30% may cause falsely high readings and hematocrit levels
over 55% may cause falsely low readings. If you do not know your
hematocrit level, consult your health care professional.
• OneTouch® Ultra® Test Strips may be used at altitudes up to 10,000
feet (3048 meters) without an effect on test results. Accurate results
were demonstrated in clinical studies performed at altitudes up to
5,280 feet (1609 meters) and in studies simulating altitudes up to
10,000 feet (3048 meters).
Health care professionals—please note these additional limitations
of procedure:
• Fresh capillary blood may be collected into heparin-containing
test tubes if the blood is used within 10 minutes. use other Do Not
anticoagulants or preservatives.
• Interferences: Acetaminophen, salicylates, 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.
In vitro diagnostic. For self-testing.
OneTouch
®
Ultra
®
Test Strips
Tiras reactivas OneTouch
®
Ultra
®
Test Strips/Tiras reactivas
OneTouch
®
Ultra
®
Test Strips
Tiras reactivas OneTouch
®
Ultra
®
IMPORTANT:
Some OneTouch® Ultra® Meters and the OneTouch
Ping® Meter Remote require coding. For meters that require
coding,
matching the code on the meter to the code on the
test strip vial is essential to obtain accurate results. Refer to the
User Guide that came with your system to determine if your
meter requires coding and get detailed instructions on coding.
Within ±5 mg/dL
(0.28 mmol/L)
Within ±10 mg/dL
(0.56 mmol/L)
Within ±15 mg/dL
(0.83 mmol/L)
Percent (and number) of meter
results that match the laboratory
test
48.8% (41/84) 84.5% (71/84) 100.0% (84/84)
Within ±5%
Within ±10% Within ±15%
Within ±20%
Percent (and number) of meter
results that match the laboratory
test
38.0%
(196/516)
68.0%
(351/516)
88.2%
(455/516)
95.7%
(494/516)
Within ±15 mg/dL
(0.83 mmol/L) or ±20%
Percent (and number) of meter results
that match the laboratory test
96.3% (578/600)
Number
of
Subjects
Number
of
Tests
Slope Intercept
mg/dL
(mmol/L)
95% CI Slope 95% CI Intercept
mg/dL (mmol/L)
Std. Error
(S
y.x
)
mg/dL
(mmol/L)
R2
100 600 0.972
-2.657
(-0.012)
0.958 to 0.985 -5.415 to 0.102
(-0.168 to 0.145)
17.743
(1.000) 0.973
Total Precision (200 control solution
tests per glucose level)
Target
Glucose
mg/dL
(mmol/L)
Mean
Glucose
mg/dL
(mmol/L)
Standard
deviation
mg/dL
(mmol/L)
Coecient
of
variation
(%)
40
(2.2)
41.0
(2.28)
1.02
(0.057) 2.50
100
(5.6)
97.4
(5.40)
1.74
(0.096) 1.78
130
(7.2)
120.7
(6.70 )
2.10
(0.116) 1.74
200
(11.1)
200.9
(11.15)
2.87
(0.160) 1.43
300
(16.7)
305.6
(16.96)
3.55
(0.197) 1.16
Glucose
Levels
Mean
Glucose
mg/dL
(mmol/L)
Standard
deviation
mg/dL
(mmol/L)
Coecient
of
variation
(%)
LOW 46.6
(2.59)
1.01
(0.056) 2.18
MID 115.1
(6.39 )
2.19
(0.121) 1.90
HIGH 350.8
(19.47)
5.48
(0.304) 1.56
IMPORTANT: For complete operating instructions and other
important technical information, refer to the User Guide that
came with your system. IF YOU HAVE QUESTIONS ABOUT THE
USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT LIFESCAN
CUSTOMER SERVICE AT 1 800 227-8862. (Contact us 7 days a
week, 8 a.m. – 8 p.m. Eastern Time. For assistance outside of
these hours, please contact your healthcare professional.)
References
OUR COMMITMENT TO YOU:
As your partner in diabetes care, we offer valuable
diabetes-related knowledge, tools and special offers online.
www.OneTouch.com
Should you need additional assistance, we welcome you to
contact us 7 days a week, 8 a.m. – 8 p.m. Eastern Time.
For assistance outside of these hours, please contact your
healthcare professional. 1 800 227-8862 (English)
m WARNING: Keep the test strip vial away from children; test
strips are a choking hazard. Do Not swallow test strips. The test
strip vial may contain drying agents that are harmful if inhaled
or swallowed and may cause skin or eye irritation. Do Not ingest
or swallow any items.
As your partner in diabetes care, we oer valuable
diabetes-related knowledge, tools and special oers online.
www.OneTouch.com
Should you need additional assistance, we welcome you to contact us
7 days a week, 8 a.m. – 8 p.m. Eastern Time.
1 800 227-8862 (English) • 1 800 381-7226 (Español)
OneTouch Ping
® Meter Remote—contact Animas Customer Service at
1 877-937-7867, 24 hours a day, 7 days a week.
For assistance outside of these hours, please contact
your healthcare professional.
Health Care Professionals: Please visit www.OneTouch.com or call
the OneTouch
® Customer Care Line at 1 800 227-8862 (English) for
additional instructions on using OneTouch
®
Meters in a clinical setting
(e.g., long term care facilities and physician oces).
Profesionales del cuidado de la salud: por favor, visiten www.OneTouch.com
o llamen a la Línea de Asistencia al Cliente OneTouch
®
al 1 800 381-7226
(Español) para obtener instrucciones adicionales sobre cómo usar los
medidores OneTouch
® en un entorno clínico (por ejemplo, centros de
cuidado a largo plazo y consultorios médicos).
AW 06626606A
Produkt Specifikationer
| Mærke: | OneTouch |
| Kategori: | Blodsukkermåler |
| Model: | Ultra |
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