Blood Glucose Monitoring System User’s Manual For in vitro diagnostic use
Table of Contents Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Monitoring System Kit Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Setting Up the Meter . . . . . . . . .
Managing Your Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Test Results in Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Blood Glucose Averages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use Language The ReliOn Ultima Blood Glucose Monitoring System is intended for in vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima system is indicated for home (lay user) or professional use in the management of patients with diabetes.
Observe caution when using around children. Small parts may constitute a choking hazard. How Your ReliOn Ultima Blood Glucose Monitoring System Works When you insert a test strip into your meter, the Apply Sample message shows on your meter’s display window. When a blood sample or control solution sample is applied to the test strip, the glucose reacts with the chemicals on the test strip. This reaction produces a small electrical current that is measured. The result shows on your meter’s display window.
Important Health-Related Information Language Low or high blood glucose results can indicate a potentially serious medical condition. If your blood glucose result is unusually low or high, or if you do not feel the way your result indicates, repeat the test with a new test strip. If your result is not consistent with your symptoms or if your blood glucose result is less than 50 mg/dL or higher than 300 mg/dL you should contact your healthcare professional and follow his or her treatment advice.
Monitoring System Kit Contents • Blood Glucose Test Strips • Control Solutions • Data Management System Language Items not included: • Carrying Case • Lancing Device Language • Logbook • Warranty Card Language • Meter • User’s Manual • Lancets Language Monitoring System Kit contains: 4
Setting Up the Meter Enter Setup Mode Language Language Language Language 5 Start with the meter off (no test strip inserted). Press and hold and until and Commands • Press to move between setup displays • Press to move forward • Press to go back • Press to turn display light On and Off appear. This indicates the beeper is turned on. indicate the beeper is turned off. Beeper Press or to change the beeper setting. Press to save the beeper setting and move to set time.
Month – Day Time Format 24 Hour Format Note: If using the 12-hour time format, AM and PM appear. The time format flashes. Press or to change the time format. Press save the time format and to move to set date format. to Language Year The year flashes. Press or until the correct year appears. Press to save the year and to move to set month. The month flashes. Press or until the correct month appears. Press to save the month and to move to set day. The day flashes.
Date Format Language Language Language Language 7 Month – Day The date format flashes. Press or to change the date format. Press save the date format and to move to the measurement units. to Day.Month IMPORTANT: Please check that the correct time and date is set before you use the meter for the first time. This will help you keep records of when you monitor and will help you and your healthcare professional make informed decisions about your care.
Testing Your Blood Glucose Do not use the meter if the display check screen does not exactly match the example. D5 13758 2012/03 E.g. Expiration date: March 31, 2012 • Use the meter within the test strip operating range • Use the test strip immediately after removing it from its foil packet • Use each test strip only once Language Language If the screen does not match, the meter may show an incorrect result. Please contact Customer Service.
D5 13758 2012/03 Language E.g. Expiration date: March 31, 2012 Language Note: See test strip instructions for use for operating range and more information on limitations of use. Test Site Language Language 9 Do not use expired test strips; they may produce inaccurate results. The expiration date is the last day of the month if only the month and year are shown. Do not use a wet, bent, scratched or damaged test strip. Do not use the test strip if its foil packet has a puncture or tear in it.
Base of thumb Upper arm change rapidly (e.g.
Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK. Language Open the foil test strip packet at the notch and tear down to remove the test strip. 4˚C Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK. Performing a Blood Glucose Test Language Insert the Test Strip With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter.
IMPORTANT: If the count down does not start, you may not have applied enough blood to the test strip. See test strip instructions for use for re-application instructions. If the countdown still does not start, remove the used strip and discard it properly. Start a new test with a new test strip. Language Language Apply Blood to the Test Strip Bring the blood drop to the white area at the end of the test strip. The blood is drawn into the test strip. Language Obtain a Blood Sample Select a test site.
Hold the blood drop to the white area until the meter beeps (if sound is on) and the status bar appears on the display. This indicates the test strip has obtained enough blood. Language Language Language Language 13 The countdown appears on the display as the meter checks your glucose level. Note: Do not remove the test strip from the meter or disturb the test strip during the countdown. View the Result The meter beeps (if sound is on) when the result appears on the display.
Understanding Blood Glucose Test Results Result Lower than 50 mg/dL What It Means Low ( hypoglycemic ) What To Do If you have symptoms such as weakness, sweating, nervousness, headache or confusion, then follow your healthcare professional’s recommendation to treat hypoglycemia. If you have no symptoms of low blood glucose, then repeat the test with a new test strip on your fingers. If the result is lower than 50 mg/dL, perform a control solution test to ensure your system is functioning properly.
Result Higher than 300 mg/dL What It Means High ( hyperglycemic ) Language Language Language Language 15 Contact Customer Service toll-free at 1-800-992-3612 What To Do If you have symptoms such as fatigue, thirst, excess urination, or blurry vision, then follow your healthcare professional’s recommendation to treat hyperglycemia. If you have no symptoms of high blood glucose, then repeat the test with a new test strip on your fingers.
Meter: What To Do Severe low blood glucose or There may be a problem with the test strip Repeat the test with a new test strip. If the result is LO, contact your healthcare professional immediately. Blood glucose level is high Repeat the test with a new test strip. If the result appears again, follow your healthcare professional’s instructions.
Meter: Display What It Means Language Appears when result is: Higher than 500 mg/dL Severe high blood glucose or There may be a problem with the test strip Language Language Repeat the test with a new test strip. If the result is HI, contact your healthcare professional immediately. Note: If you see the error messages E-3 or E-4, consult the Error Messages section in this user’s manual.
There are three levels of control solution available (Low, Mid, High). Contact Customer Service for information on how to obtain control solutions. Language Language Control solutions may be used with glucose test strips.
Important Control Solution Testing Notes Language • Use only MediSense control solutions with the meter • Replace the cap securely on the bottle immediately after use Language Do not use control solution past the expiration date. Do not add water or other liquid to control solution. Do not swallow or inject the control solution. Do not use the control solution as eye drops.
Insert the Test Strip With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter. Note: The meter turns off after 3 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter. Language Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK. Language Open the foil test strip packet at the notch and tear down to remove the test strip.
This display always appears when the meter is turned on. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service. Language See “Testing Your Blood Glucose” section for more information. Time and date (if set) appear next. Language Language Language 21 LOT 00000 and the Apply Sample symbols and also appear. Press to mark the test as a control solution test. appears.
The countdown appears on the display as the meter checks the glucose level. Note: Do not remove the test strip from the meter or disturb the test strip during the countdown. If the countdown does not start, remove and discard the used test strip, turn off the meter and try again with a new strip. Language Language Language Hold the control solution drop to the white area until the meter beeps (if sound is on) and the status bar appears on the display.
Language View the Result The meter beeps (if sound is on) when the result appears on the display. The test is complete (examples shown). The result is stored in memory as a control solution result or you can write it in a logbook as a control result. Language Compare the control solution result to the range printed on the blood glucose test strip instructions for use. The result should fall within the range.
Press to turn the meter on. This display always appears when the meter is turned on. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service. See “Testing Your Blood Glucose” section for more information. Language Start with the meter off (no test strip inserted). Language Viewing Test Results in Memory Language Meter memory stores up to 450 events – control solution and blood glucose results, and other meter information.
Your most recent result, with time and date (if set) it was obtained, appears next. The following symbols indicate the type of result: Language = Blood glucose result = Glucose control solution result Language Press to review the previous result. Repeat this for each result you wish to review. Note: To exit meter memory at any time, press and hold . Language Appears on the display when there are no previous results to view.
Language Language Language IMPORTANT: • Set the date and time before testing to be able to review averages • Averages do not include glucose control solution results and results that do not show time and date • Control solution results not marked as control solution tests may cause averages to be inaccurate • appears on the display when there are no current averages to view blood glucose test results appear in averages as 20 mg/dL • blood glucose test results appear in averages as 500 mg/dL • Lan
While in memory, press . Your 7-day average appears. Note: n = number of results included in your 7-, 14-, or 30-day average. Language Press to view the 14-day average. Language Language Language 27 Press to view the 30-day average. Press to return to the 7-day average, or Press to return to the memory screen. Press and hold of inactivity. Contact Customer Service toll-free at 1-800-992-3612 to turn off the meter.
Transferring Results to a Computer What To Do The temperature is too hot or too cold for the meter to work properly 1. Move the meter and test strips to a location where the temperature is within the test strip operating range. (See test strip instructions for use for the appropriate range.) 2. Wait for the meter and test strips to adjust to the new temperature. 3. Repeat the test using a new test strip. 4. If the error reappears, contact Customer Service. Meter error 1. Turn off the meter. 2.
Message Language Language Language Language 29 What It Means What To Do The blood glucose level may be too low to be read by the system or There may be a problem with the test strip 1. Review the testing instructions. 2. Repeat the test using a new test strip. 3. If the error reappears, contact your healthcare professional immediately. The blood glucose level may be too high to be read by the system or There may be a problem with the test strip 1. Repeat the test using a new test strip. 2.
or 1. Check that you are using the correct strip for this meter. (See test strip instructions for use to verify your strip is compatible with this meter.) 2. Repeat the test using a test strip for use with your meter. 3. If the error reappears, contact Customer Service. No coding required or Test strip may be damaged, used, or the meter does not recognize it 1. Check that you are using the correct test strip for this meter.
Troubleshooting Language What It Means Language The meter Test strip is not does not enter inserted correctly or test mode fully into the meter after inserting a test strip. What To Do 1. With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter. 2. If the meter still does not enter test mode, contact Customer Service. Language No battery is installed Battery is installed incorrectly 1. Install battery with (+) facing up.
Sample applied after meter turns off 1. 2. 3. 4. Defective meter or test strip 1. Remove the used strip and discard it properly. 2. Repeat the test using a new test strip. 3. If the test still does not start, contact Customer Service. Remove the used strip and discard it properly. Review the testing instructions. Repeat the test using a new test strip. If the test still does not start, contact Customer Service. Language 1. See test strip instructions for use for re-application instructions. 2.
Maintaining the Meter Replacing the Battery Language Language Language Language 33 The meter comes with a CR 2032 lithium (coin cell) battery installed. It provides power for about 1,000 tests. • Appears on the display when the battery is low. • Causes the display light to fail to turn on. appears, you may still use the meter and the results will be accurate. When The display light will not work. Replace the battery immediately. When appears alone, the meter is not usable.
3. Insert a new CR 2032, lithium (coin cell) battery: (+) facing up. 4. Slide the battery cover into place until it clicks. Note: Dispose of used batteries properly. Language Language If the meter does not include a plastic tab, push the battery upward to remove it. Language 2. If the meter includes a plastic tab, pull on the tab to remove the battery. Language 1. Gently push the battery cover in and up to remove it.
Language 5. Press and hold to turn the meter on. If the meter does not turn on, check to see that the battery was installed properly. If meter turns on, the meter may prompt you to reset the time and date. (See ‘Setting Up the Meter’ in this user’s manual.) Note: Test results will be not be lost even if the meter loses its time and date settings.
Storing the Meter Store the meter in the carrying case provided. Language Language IMPORTANT: Do not try to clean the test strip port. Do not pour liquid into the test strip port or onto the buttons. Do not immerse the meter in water or other liquid. Language Avoid getting dirt, dust, blood, control solution, or liquid in the meter test strip port. Clean the outside of the meter using a damp cloth and mild soap.
Specifications Language Language Language Language 37 Size Length 7.47 cm Width Top 5.33 cm Bottom 4.32 cm Depth 1.63 cm Weight 40 to 46 grams Power Source 1 CR 2032 Lithium (coin cell) battery Battery Life Approximately 1,000 tests Memory Up to 450 events, including control solution results, blood glucose results, and other meter information. Storage Temperature Meter -25 ° to 55 °C (–13 ° to 131 °F) Test strips See test strip instructions for use.
Assay Method Amperometric electrochemistry See blood glucose test strip instructions for use. Control Solution Range Language See blood glucose test strip instructions for use. Functions Blood glucose testing Memory 450 events Glucose averaging 7-, 14-, and 30-day Control solution marking and testing Beeper On: When countdown starts and ends. Display Light On: Stays on during countdown; turns off 30 seconds after results appear. Stays on while transferring results to a computer.
Operating Range See operating range of the test strip you are using. System temperature Meter relative humidity 10% to 90%, non-condensing Language 10 ° to 50 °C (50 ° to 122 °F) Language Meter temperature System relative humidity 10% to 90%, non-condensing System altitude Clinical testing demonstrates that altitudes up to 2,195 meters (7,200 feet) above sea level do not affect results See test strip instructions for use.
Language Language American Diabetes Association Position Statement:Standards of Medical Care in Diabetes—2010. Diabetes Care 2010;33 (Suppl.1):S11-S61 Language 1.
Distributed by: Wal-Mart Corp. Bentonville, AR 72716, USA Manufacturer: Abbott Diabetes Care, Inc. 1360 South Loop Rd. Alameda, CA 94502, USA Customer Service: 1-800-992-3612 Call toll-free 24 hours a day, 7 days a week. ReliOn® is a registered trademark used under license by Abbott Diabetes Care, Inc.
