Advertisement
Patent information
The system described herein is covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, 6,284,125, 7,112,265, and D546,216. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,733,655, 7,250,105, 7,468,125. Purchase of this device does not act to grant a use license under these patents. Such a license is granted only when the device is used with OneTouch® Ultra® Test Strips. No test strip supplier other than LifeScan 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.
Before you begin
Before using this product to test your blood glucose, carefully read this User Guide and the inserts that come with the OneTouch® Ultra® Test Strips and OneTouch® Ultra® Control Solution. Take note of warnings and cautions throughout this User Guide, which are identified with . Many people find it helpful to practice the test with control solution before testing with blood for the first time. See Control solution testing.
Intended use
The OneTouch® UltraMini® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® UltraMini® System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of diabetes or for testing newborns.
Test principle
Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.
The OneTouch® UltraMini® Blood Glucose Monitoring System
Included with your kit:
Keep the meter and testing supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective disks on the lancets and control solution vial cap are choking hazards.
METER
TEST STRIP
Turning your meter on
To perform a test, insert a test strip as far as it will go. The display will turn on and the meter will briefly perform system checks. Or, to change the time and date, start with the meter off, then press and hold ▼ for five seconds until the start-up test screen appears. After the start-up test screen, the pre-set time and date will appear on the display. Or, if you want to turn the meter on to review past results, start with the meter off, then press and release ▼.
Start-up Test Screen
Every time you turn your meter on, a start-up test screen will appear for two seconds. All segments of the display should appear briefly on the start-up test screen to tell you that the meter is working properly. To check that all display segments are working, as soon as the start-up test screen appears, press and hold ▲ to keep the start-up test screen display on. Release ▲ to proceed to the next step. If the meter does not power on, try changing the meter battery. See Replacing the battery.
Turning your meter off
There are several ways to turn your meter off:
If any information is missing from the start-up test screen, there may be a problem with the meter. Call LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week).
Your OneTouch® UltraMini® Meter comes with the time, date and unit of measure pre-set. Before using your meter for the first time or if you change the meter battery, you should check and update the time and date. Make sure you complete steps 1 to 7 below to ensure your desired settings are saved.
If your display shows mmol/L rather than mg/dL, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
Have these things ready when you test your blood glucose level:
If you cannot test due to a problem with your testing supplies, contact your healthcare professional or LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). Failure to test could delay treatment decisions and lead to a serious medical condition.
Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results. Each time you test, check to make sure the code numbers match.
Overview of the Lancing Device
*The blue (or black) cap and clear cap are also used for depth adjustment
NOTE: If you do not have a lancing device, please refer to the instructions that came with your lancing device.
To reduce the chance of infection:
Preparing your sample site
Before you test your blood glucose, wash your hands and forearm (if applicable) thoroughly with warm, soapy water. Rinse and dry.
Lancing and sampling from your fingertip
Choosing the right sampling site at the right time
The OneTouch® UltraMini® Meter allows you to sample blood from your fingertip, forearm or palm. Forearm and palm sampling is also referred to as "alternate site testing" (AST). At times, results obtained at the forearm or palm may be different from a fingertip measurement. Talk to your healthcare professional before you begin using your forearm or palm for sampling.
If you are testing: | Use blood sample from your: |
Routinely before meals Prior to or more than two hours after:
| Fingertip, forearm, or palm |
When your blood glucose is changing rapidly, such as:
| Fingertip |
Do Not test on your forearm or palm when:
Remember: Consult with your healthcare professional before using your forearm or palm for testing.
Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. If bruising occurs at an alternate site or you have difficulty getting a sample, consider sampling from a fingertip instead. You may want to review the choice of sites with your healthcare professional.
Lancing and sampling from an alternate site
Sampling from your palm or forearm allows you to use your fingertips less often. You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip. Getting a blood sample from your forearm or palm is different than getting a sample from your fingertips.
Forearm sampling
Choose a fleshy area of the forearm away from bone, visible veins and hair. Sometimes there is less blood flow to the forearm than to the fingertips. To help you get a large enough drop of blood, you may gently massage or apply warmth to the site to increase blood flow.
Palm sampling
Choose a fleshy area on the palm below your thumb or little pinky finger. Select a spot with no visible veins and away from deep lines, which may cause your blood sample to smear.
The clear cap is used for forearm and palm sampling only. Replace the blue (or black) cap with the clear cap.
Once you have a blood sample and your meter shows the screen with the flashing blood drop icon , you are ready to obtain a blood glucose result. If your meter does not show the screen with the flashing blood drop icon , remove the unused test strip and re-start the test process. See Getting a blood sample.
If you test at the low end of the operating range (43–111°F) and your glucose is high (over 180 mg/dL), the reading on your meter may be lower than your actual glucose. In this situation, repeat the test in a warmer environment with a new test strip as soon as possible.
If mg/dL does not appear with the test result, call LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
Error messages
If you get an Er message on your screen rather than a result, see Understanding error and other messages.
Unexpected test results
Refer to these cautions whenever your results are lower than, higher than, or otherwise not what you expect.
Dehydration and low glucose results
Severe dehydration resulting from excessive water loss may cause false low results. If you think you are suffering from severe dehydration, contact your healthcare professional immediately.
Low glucose results
If your test result is lower than 70 mg/dL or is shown as LO, it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test.
High glucose results
If your test result is higher than 180 mg/dL, it may mean hyperglycemia (high blood glucose). If you are uncertain about this test result, consider re-testing. Your healthcare professional can work with you to determine what actions, if any, you should take if your results are higher than 180 mg/dL.
If your meter displays HI, you may have a very high blood glucose level (severe hyperglycemia) exceeding 600 mg/dL. Re-check your glucose level. If the result is HI again, this may indicate a severe problem with your blood glucose control and it is important you obtain and follow instructions from your healthcare professional without delay.
Repeated unexpected glucose results
If you continue to get unexpected results, check your system with control solution. See Control solution testing. If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this User Guide, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional.
Unusual red blood cell count
A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results.
After getting a result
Once you have read your result, you may:
Removing the used lancet
Remove the lancing device cap by snapping it off. Cover the exposed lancet tip before removing the lancet. Place the lancet protective disk on a hard surface. Push the lancet tip into the disk. Remove the lancet and place it in a container for sharp objects. Replace the cap.
Disposing of the used lancet and test strip
It is important to discard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your local regulations or your healthcare professional's recommendations for proper disposal.
The meter stores a maximum of 500 blood glucose test results. When the meter memory is full, the oldest result is dropped as the newest is added. Results are stored automatically when you test, along with the time, date and unit of measure. You can review the results stored in the meter memory, starting with the most recent.
If your meter is off, press and release ▼ to turn it on. After the start-up test screen, your most recent test result will appear on the display. "M" also appears to indicate memory mode.
If you have just completed a test, leave the test strip in the meter and press ▼ to enter the memory mode. Your most recent blood glucose test result appears along with "M".
Press ▼ to move to the previous result stored in the meter. Then, press ▲ or ▼ to move forward or backward through all of your results. When you're finished reviewing past results, press and hold ▼ for two seconds until the meter turns off.
NOTE: If no results are currently stored in the meter, "–––" will appear on the display.
You can use your meter with OneTouch® Diabetes Management Software (DMS) for storing your records and to help you spot patterns for planning meals, exercise, and medication. OneTouch® DMS puts information downloaded from the meter into charts and graphs. If you are a current OneTouch® DMS user, additional software updates may be required for use with the OneTouch® UltraMini® Meter. Please visit www.OneTouchDiabetesSoftware.com.
OneTouch® Ultra® Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly.
Do a control solution test:
Do Not swallow control solution; it is not for human consumption. Do Not apply control solution to the skin or eyes as it may cause irritation.
Start with the meter off. If you have turned the meter on to change settings or review past results, turn it off.
The control solution range printed on the test strip vial is for OneTouch® Ultra® Control Solution only. It is not a recommended range for your blood glucose level.
If you continue to get control solution results that fall outside the range printed on the test strip vial, Do Not use the meter, the test strips, or the control solution. Call LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week).
Your OneTouch® UltraMini® Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent). Replacement batteries can be found in most stores where batteries are sold. Your meter comes with the battery already installed. A battery icon appears in the far righthand side of the meter display to indicate low battery.
When there is enough power for a minimum of 100 more tests, the battery icon will appear.
After each test and when reviewing past results, the battery icon will now flash to remind you to change the battery as soon as possible.
When the battery icon is flashing by itself on the display, you cannot perform a test. You must install a new battery before using your meter.
Your OneTouch® UltraMini® Blood Glucose Monitoring System does not need any special maintenance.
Storing your system
Store your meter, test strips and control solution in your carrying case after each use. Store each item in a cool, dry place below 86°F, but Do Not refrigerate. Keep all items away from direct sunlight and heat. Tightly close the cap on the test strip vial and/or control solution vial immediately after use to avoid contamination or damage. Store test strips only in their original vial.
Checking for expiration or damage to test strips and control solution
Test strips and control solution have expiration dates printed on their vials. When you first open a test strip or control solution vial, you must record the discard date in the space provided on the label:
Do Not use the test strips or control solution after the expiration date printed on the vial or the discard date, whichever comes first, or your results may be inaccurate.
Do Not use your test strips if your vial is damaged or left open to air. This could lead to error messages or tests that read higher than the actual value. Call LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week) immediately if the test strip vial is damaged.
Cleaning your meter
To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do Not use alcohol or another solvent to clean your meter.
Do Not get any liquids, dirt, dust, blood, or control solution inside the meter through the test port or the data port. Never spray cleaning solution on the meter or immerse it in any liquid.
Cleaning your lancing device and clear cap
To clean these items, wipe them with a soft cloth dampened with water and mild detergent. Do Not immerse the lancing device in any liquid.
To disinfect these items, prepare a solution of one part household bleach to ten parts water. Wipe the lancing device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. After disinfecting, rinse briefly with water and allow both to air dry.
The OneTouch® UltraMini® Meter displays messages when there are problems with the test strip, with the meter, or when your blood glucose levels are higher than 600 mg/dL or lower than 20 mg/dL. Messages do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing a warning message.
Message | What it means | What to do |
You may have a very low blood glucose level (severe hypoglycemia), lower than 20 mg/dL. | This may require immediate treatment according to your healthcare professional's recommendations. Although this message could be due to a test error, it is safer to treat first and then do another test. | |
You may have a very high blood glucose level (severe hyperglycemia), over 600 mg/dL. | Re-check your glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional without delay. | |
The meter has detected that the temperature is above the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range of 43–111°F. | Repeat the test after the meter and test strips have reached a temperature within the operating range. | |
The meter has detected that the temperature is below the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range of 43–111°F. | Repeat the test after the meter and test strips have reached a temperature within the operating range. | |
No result in memory, such as the first time use of the meter. or, Your meter was unable to recall this result. | You can still perform a blood glucose test and get an accurate test result. Contact LifeScan Customer Service at 1 800 227- 8862 (available 24 hours a day, seven days a week) to report this occurrence if this is not your first time use of the meter. | |
Error message indicates there is a problem with the meter. | Do Not use the meter. Contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
Error message could be caused either by a used test strip or a problem with the meter. | Repeat the test with a new test strip; see Testing your blood glucose. If this message continues to appear, contact LifeScan Customer Service at 1 800 227- 8862 (available 24 hours a day, seven days a week). | |
Error message indicates that the blood or control solution sample was applied before the meter was ready. | Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing blood drop icon appears on the display. If this message continues to appear, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
One of the following may apply: You may have high glucose and have tested in an environment near the low end of the system's operating temperature range (43–111°F). or, | If you tested in a cool environment, repeat the test in a warmer environment with a new test strip; see Testing your blood glucose. If this error message appears again, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
There may be a problem with the test strip. For example, it may have been damaged or moved during testing. or, | If you tested in a normal or warm environment, repeat the test with a new test strip; see Testing your blood glucose. If this error message appears again, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
The sample was improperly applied. or, | If you applied the sample incorrectly, review blood application (see Testing your blood glucose) or control solution testing (see Control solution testing) and repeat the test with a new test strip. If the error message appears again, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
There may be a problem with the meter. | If this error message appears again, contact LifeScan Customer Service at 1 800 227-8862 (available 24 hours a day, seven days a week). | |
The meter has detected a problem with the test strip. Possible causes are test strip damage or an incompletely filled confirmation window. | Repeat the test with a new test strip. Refer to blood application (see Testing your blood glucose) or control solution testing (see Control solution testing). | |
Meter battery is low but there is enough power to perform a test. | When the flashing battery icon first appears, there is enough power for a minimum of 100 more tests. Test results will still be accurate, but replace the battery as soon as possible. | |
The icon flashes on the display by itself when there is not enough battery power to perform a test or view previous results. | Replace the meter battery. |
Comparing meter and laboratory results
Test results with the OneTouch® UltraMini® Meter are plasma-calibrated. This helps you and your healthcare professional to compare your meter results with laboratory tests. If you have been using another type of meter—one that provides whole blood-calibrated results—you may notice that your test results with the OneTouch® UltraMini® Meter are approximately 12% higher. OneTouch® UltraMini® Meter test results and laboratory test results both are expressed in plasma-equivalent units. However, your meter result may differ from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way. Your OneTouch® UltraMini® Meter glucose value is considered accurate when it is within ±20% of the laboratory measurement. There are some specific situations that could cause a difference of more than ±20%:
For accuracy and precision data and for important information on limitations, see the insert that comes with your test strips. To maximize your chances of an accurate comparison between meter and laboratory results, follow a few basic guidelines:
Before going to the lab
While at the lab
1Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.
Technical specifications
Reported result range | 20–600 mg/dL |
Calibration | Plasma-equivalent |
Sample | Fresh capillary whole blood |
Test time | 5 seconds |
Assay method | Glucose oxidase biosensor |
Meter power source | One replaceable 3.0 Volt CR 2032 lithium battery (or equivalent) |
Unit of measure | mg/dL |
Memory | 500 blood glucose test results |
Automatic shutoff | 2 minutes after last action |
Size | 4.25 x 1.26 x.67 inches |
Weight | Approximately 1.4 ounces, with battery |
Operating ranges | Temperature: 43–111°F Altitude: up to 10,000 feet Relative humidity: 10–90% Hematocrit: 30–55% |
Battery ratings | One 3.0 V d.c., 3 mA (one CR 2032 battery) ⎓ direct current |
Symbols
Cautions and Warnings: Refer to safety-related notes in the User Guide and inserts that came with your meter and testing supplies.
⎓Direct current
Low battery
Serial Number
Electrical and safety standards
The meter has been tested for immunity to Level 4 electrostatic discharge as specified in IEC 61000-4-2. This meter has been tested for immunity to radio frequency interference over the frequency range 80 MHz to 2.5 GHz at 3 V/m as specified in IEC 61000-4-3. Degree of protection rating: Minimum of IP2X. This meter complies with CISPR 11:2003, Class B (Radiated Only). Emissions of the energy used are low and are not likely to cause interference in nearby electronic equipment.
CAN/CSA C22.2 61010-1:04, UL 61010-1:04, IEC 61010-1 and IEC 61010-2-101.
Guarantee
LifeScan guarantees that the OneTouch® UltraMini® Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable.
As your partner in diabetes care, we welcome you to contact us anytime.
1 800 227-8862 (English)
www.OneTouchDiabetes.com
If you cannot reach Customer Service, contact your healthcare professional for advice.
Manufactured for: LifeScan, Inc. Milpitas, CA USA 95035
© 2009 LifeScan, Inc. Milpitas, CA 95035
Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.
Advertisement
Thank you! Your question has been received!
Need Assistance?
Do you have a question about the Ultra Mini that isn't answered in the manual? Leave your question here.