BD Consumer Healthcare 1 Becton Drive Franklin Lakes, New Jersey 07417 Lancets manufactured by BD. Lancet device and control solution(s) manufactured for BD. Paradigm, Solutions, Paradigm Link, Bolus Wizard and MiniMed are registered trademarks of Medtronic MiniMed. BD, BD Logo, BD Latitude, BD Logic and BD Ultra-Fine are trademarks of Becton, Dickinson and Company. © 2003 BD Monitor and test strips manufactured for BD by Nova Biomedical Corporation, Waltham, MA 02454. U.S. Patent No. 6,258,229 and other U.
Welcome Thank you for choosing the Paradigm Link™ Blood Glucose Monitor. This Owner’s Guide contains important information on the meter and how it works. Please read it carefully before using your new blood glucose meter. The Paradigm Link™ Blood Glucose Monitor, developed by Medtronic MiniMed and BD, is designed to be convenient and easy to use. It is the first blood glucose meter designed for wireless communication with Paradigm® Model 512 or higher Insulin Infusion Pumps.
Important Information ! • Before you begin using your new Paradigm LinkTM Blood Glucose Monitor, please read all of the instructions provided in this Owner’s Guide. • Use the meter only if the protective seal on the box containing your Paradigm Link™ Blood Glucose Monitor is unbroken. • Perform all quality control checks recommended in your Owner’s Guide. • Consult with your diabetes healthcare professional and follow his or her guidance for your blood glucose monitoring routine.
Table of Contents Getting to Know Your Paradigm Link™ Blood Glucose Monitor Meter Components .........................................................................................................................2 Kit Contents........................................................................................................................................3 Meter Display ...................................................................................................................................
Getting to Know Your Paradigm Link™ Blood Glucose Monitor Kit Contents Monitor (Battery installed) BD™ Lancet Device BD Ultra-Fine™ 33 Lancet Meter Components Vial of 10 BD™ Test Strips Owner’s Guide BD™ Control Solution Test Strip Slot and Data Port* Monitor Display Arrow Buttons Left arrow moves backward; right arrow moves forward Insulin Recording Button Mode Button Getting Started Poster Quick Reference Guide Day Case Warranty Card * Accepts a cable to download stored data to a personal comput
Meter Display Test Strips When you turn the Paradigm LinkTM Blood Glucose Monitor on, the “all segments” display appears briefly. This tells you that all the display segments are working properly. BD™ Test Strips are designed for use with your Paradigm LinkTM Blood Glucose Monitor, BD Logic™ Blood Glucose Monitor or BD LatitudeTM Diabetes Management System only. Use each test strip only once, then discard. Do not reapply blood to the test strip. Beep Symbol Beeper is preset to ON A.
Important BD™ Test Strip Information • Use only BD™ Test Strips when testing. • Remove the test strip from the vial only when ready to test. Lancet Device The diagram below shows the components of the BD™ Lancet Device. Depth Penetration Dial (1 = shallow to 6 = deep) Cap Arming Knob • Store test strips at room temperature below 86°F (30°C). Do not refrigerate or freeze. • Test strips should be stored only in original vial. • Keep vial cap closed tightly after each use.
Getting Started Before You Measure Your Blood Glucose Level for the First Time: 1) Program your meter ID number into your Paradigm® Model 512 or higher Pump. See the Paradigm Pump User Guide or the Paradigm Link™ Getting Started Poster 2) Set your meter to the same time and date as your pump. See page 9. 3) Code your meter. See page 13. 4) Use control solution to test your meter. See page 15. 5) Now you are ready to test your blood glucose level. See page 22.
6. Set Year: Press the right or left arrow button until the correct year appears. HOW TO SET THE TIME, DATE, AND BEEPER Meter is off, with no test strip inserted in the test strip slot. 1. Begin Setup: Press and continue to hold the Mode button until you hear a short beep and see the flashing hour displayed. Release the Mode button. 7. Press the Mode button briefly to confirm your choice and to advance to set the month. AM Flashing Hour Display 2.
12. Set Beeper: Beeper is preset to “ .” Press the right or left arrow button to select the beeper setting (ON or OFF). Coding Your Meter WHY CODING YOUR METER BEFORE TESTING IS NECESSARY Set Beeper (Example) Your Paradigm LinkTM Blood Glucose Monitor must be manually “coded” to match the vial of test strips you will be using in order to provide accurate blood glucose test results. NOTE: Instructions in this guide assume the beeper is set to You should code your meter: ,” you will not hear the “ .
3. When the codes match, press the Mode button. A blinking blood drop shows that the meter is ready for you to test. To run a control solution test, refer to page 15. To run a blood glucose test, refer to page 22. HOW TO CODE YOUR METER Meter is off, with no test strip inserted in the test strip slot. 1. Insert a BD™ Test Strip into the test strip slot. The meter turns on and briefly displays the “All Segments” display. To turn off the meter, remove and discard the used test strip.
Important Control Solution Information HOW TO RUN A CONTROL SOLUTION TEST Meter is off, with no test strip inserted in the test strip slot. • Use only the BD™ Control Solution for the test. • Check the expiration date on the control solution vial. Do not use the control solution if the expiration date has passed. • Store only for 3 months after first opening. When you open a new vial of control solution, count forward 3 months and write that date on the label of the control solution vial.
5. Shake the control solution vial and discard a drop before use. Squeeze a drop of control solution onto a clean, hard, dry surface. 3. A blinking blood drop tells you that the meter is ready for the next step. Squeeze Drop of Control Solution Blinking Blood Drop 4. Mark as a control solution test by pressing the right or left arrow button until a “ ” appears. 6. While holding the meter, touch the edge of the inserted test strip to the drop of control solution.
Out-of-range results may be caused by the following: 7. The display counts down from 5 seconds as the meter performs the test. Test Countdown 8. When the test is finished, a long beep sounds and the meter displays the result. mg/dL Test Result (Example) • You may not be doing the test properly. Retest and follow the instructions carefully. • The Paradigm LinkTM Blood Glucose Monitor may not be coded properly to match the test strips being used.
How to Test Your Blood Glucose 3. Insert a BD Ultra-FineTM 33 Lancet into the lancet holder. Insert Lancet Preparing the Lancet Device Before testing, wash your hands with soap and warm water. Dry thoroughly. 4. Remove the lancet cover while holding the base of the lancet. 1. Unscrew the cap from the BD™ Lancet Device. Remove Lancet Cover Unscrew Cap 2. Select the penetration depth by turning the cap dial from 1 (shallow) to 6 (deep).
Getting and Applying a Blood Sample to the BD™ Test Strip Inserting the BD™ Test Strip Meter is off, with no test strip inserted in the test strip slot. 1. Place the armed BD™ Lancet Device securely on the side of your finger and press the trigger button to activate the device. If necessary, gently squeeze your finger to help form a drop of blood. 1. Insert a BD™ Test Strip into the test strip slot. The meter turns on and briefly displays “All Segments.
2. Apply blood drop to the edge of the test strip. The blood is drawn into the test strip. Hold your finger to the edge of the test strip until you hear a short beep or see the meter display begin to count down. Apply Blood Drop Correct The glucose result will flash while meter is transmitting the glucose result to the insulin pump. Removing the strip will not automatically turn off the meter while RF transmission is in progress (flashing).
If the test result is higher than 600 mg/dL, the meter sounds 3 quick beeps and the display will read “ .” You may have high blood sugar. Retest your blood glucose immediately using a new test strip. If your reading is still high, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately. The meter will not transmit when the glucose result is " ".
MARKING FOR IDENTIFICATION FUNCTION Mark a Single Blood Glucose Test So It Is Not Sent To Your Paradigm® Model 512 or Higher Pump If you want to take a single blood glucose measurement and not have that result sent to your Paradigm® Model 512 or higher Pump, you can mark it as a control solution test. 1. Insert a BD™ Test Strip into the test strip slot. 2. Match the code number on the display with the code on the test strip vial. 3. A blinking blood drop next step.
Marking a Blood Glucose Test For Identification 4. To save the marked test result, press the Mode button. A blood glucose test can be marked for identification after completing a test. For an explanation of situations in which you may wish to mark a blood glucose test, refer to page 31. 1. Test your blood glucose. (Refer to page 22 for how to test.) mg/dL 2. After a blood drop is applied to the test strip, the display counts down from 5 seconds and shows your test result.
How to Use Your Meter’s Basic Memory Functions Reviewing Your Basic Memory Functions The Basic Memory functions help you and your healthcare professional track changes in your blood glucose levels over time. 2. Your Most Recent Blood Glucose Test Result with date and time of testing is shown on the display. (To set the correct date and time, refer to page 10.
How to Use Your Meter’s Optional Functions Your Paradigm LinkTM Blood Glucose Monitor has Optional functions that can help you and your healthcare professional manage your diabetes. The Optional functions allow you to: Setting the Optional Functions Meter is off, with no test strip inserted in the test strip slot. 1. Begin Setup: Press and continue to hold the Mode button. You will hear 2 short beeps and see “ ” and the word “ .” Release the Mode button. 1.
4. Set Insulin Recording Function: The Insulin Recording function is preset to “ .” Press the right or left arrow button to select ”). the setting (“ ” or “ 5. Press the Mode button briefly to confirm your choice and to advance to set Time-Specific Averages. 6. Set Time-Specific Averages: The Time-Specific Averages function automatically comes with the 7-Day Average function. The Time-Specific Averages function is preset to “ .” Press the right or left arrow button to select the setting (“ ” or “ ”). 8.
11. Set Marking for Identification Function: The Marking for Identification function is preset to “ .” Press the right or left arrow button to select the setting (“ ” or “ ”). Press the Mode button briefly to confirm your choice and to advance to end of setup. Reviewing Your Optional Functions Meter is off, with no test strip inserted in the test strip slot. Set Marking Function 2. Your Most Recent Blood Glucose Test Result with date and time of testing is shown on the display.
5. Your Last Insulin Record with date and time of recording is shown on the display. The display will alternate between insulin dose and insulin type. (Refer to page 53 for Labeling Your Insulin Types.) 9. Press the Mode button briefly to advance to the next function. U Mem. Mem. PM PM Insulin Record (Example) 6. If you wish to review up to 30 stored insulin records, continue to press the left arrow button. 11. Press the Mode button briefly to advance to the next function.
Uses For Your Meter’s Optional Functions 13. To review the individual 3 test results that make up the A1 average, press the left arrow button. “ ” is displayed after the last test result. 7-DAY AVERAGE Mem. mg/dL Mem. mg/dL AM AM Your Paradigm Link™ Blood Glucose Monitor allows you to review the average of all test results taken in the last 7 days. The average will not include marked or control solution test results.
This function lets you and your healthcare professional: • Choose up to 4 time periods during the day for which you want to track results. The meter labels these times as A1, A2, A3, and A4. You can also view the 3 individual test results, with date and time, that make up the A2 Average. Each flashing box represents one of the 3 test results that makes up the average. • View your Time-Specific Averages on the meter display. • View the 3 test results that make up each Time-Specific Average.
Recording Your Insulin Doses Meter is off, with no test strip inserted in the test strip slot. Your Paradigm Link™ Blood Glucose Monitor allows you to enter insulin dosing information into its memory. This feature might be used if you inject insulin in addition to the insulin you infuse with your pump. 2. After you deliver your insulin, press and release the Insulin Recording button. The meter turns on and advances to insulin recording. The and a flashing “1” appear on the display.
6. To save the insulin dose, press the Mode button briefly, or press the Insulin Recording button. A long beep sounds to confirm that the insulin dose was saved. (Refer to page 51 for marking your insulin dose.) Marking an Insulin Dose 7. If you inject more than one type of insulin at one time, turn off the meter by pressing and holding the Mode button. Repeat steps 2 through 6 to record your next insulin type. 1. Record your insulin dose. (Refer to page 48 for how to record your insulin doses.) 8.
Labeling Your Insulin Types Marking Insulin Doses: Some examples of how you may use the Marking function to mark an insulin dose are shown below. • You may wish to mark a dose that you are recording to indicate that you entered the information at a different time than you actually delivered the insulin. • You may wish to indicate that a dose amount was different than what you normally take at that time.
Additional Information Summary: How to Review Your Basic and Optional Functions STEPS RESULT Press Mode Meter turns ON DISPLAY SETUP REQUIRED? Display Messages and Troubleshooting Guide No U Mem. mg/dL Avg. mmol/L AM PM Press arrow buttons Review up to Last 30 Test Results Mem. mg/dL DISPLAY WHAT IT MEANS WHAT TO DO Yes (see page 37) System Check. Verifies that all segments are working.
DISPLAY WHAT IT MEANS Meter is ready to accept a blood sample. WHAT TO DO DISPLAY Apply a blood sample to the test strip. Refer to page 22 for how to test your blood glucose. WHAT IT MEANS WHAT TO DO Your blood glucose reading is lower than 20 mg/dL. You may have low blood sugar. Retest your blood glucose immediately. If your reading is still “ ,” you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.
DISPLAY WHAT IT MEANS WHAT TO DO The average of all blood glucose test results taken in the last 7 days. No action required. The average of all blood glucose test results taken in the last 14 days. No action required. DISPLAY AM Mem. mg/dL AM A control solution test result. No action required. A control value will not transmit to the pump. A marked blood glucose test result. No action required. A marked insulin dose. No action required. System Error.
DISPLAY WHAT IT MEANS Incorrect application of blood sample or control solution onto the test strip. Test strip may be damaged. Meter does not • Battery is dead. turn on after • Battery is installed inserting incorrectly or there is no a test strip. battery in the meter. • Test strip is inserted upside down or incompletely. • Meter may not be working properly. WHAT TO DO DISPLAY Insert a new test strip and perform the test again. Meter does not begin test countdown after applying a blood sample.
The meter will tell you the battery is low by displaying meter is turned on. 4. Open the battery door by pushing back on the opener and lifting up as shown. when the • You can still get accurate test results or review your memory functions. However, when the symbol first appears, there is only enough power to perform approximately 20 tests. • When the battery runs out, the meter will not turn on.
Healthcare Precautions and Limitations Conditions That May Affect Results • Severe dehydration and excessive water loss may cause false low results. If you think you may be dehydrated, consult your healthcare professional immediately. Elevated levels of acetaminophen, tolazamide, uric acid, bilirubin, ephedrine, and methyldopa may affect results. • Test results greater than 240 mg/dL may mean high blood sugar (hyperglycemia). Test results lower than 60 mg/dL may mean low blood sugar (hypoglycemia).
Specifications Test Capillary blood glucose referenced to plasma Assay Method Glucose oxidase biosensor Test Result Range 20 mg/dL to 600 mg/dL Test Time 5 seconds Test Strip Volume 0.3 µL* Radio Frequency (RF) 916.
Notes
Paradigm Link™ Blood Glucose Monitor Notes Paradigm Link™ Blood Glucose Monitor BD™ Control Solution BD Ultra-Fine™ 33 Lancets BD™ Test Strips BD™ Lancet Device
