Instruction/ maintenance manual of the product Blood Glucose Meter MODEL Ascensia Elite Bayer HealthCare
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THE NEW FACE of Glucometer ® Diabetes Care System U SER G UIDE F or Use W ith Ascensia E LITE ™ Blood Glucose Meter Need Help W ith Reimbursement? Call Our Bayer Care Help Line: 1-877-787-1912. If Y ou Have Any Questions , Comments or Need Help W ith Reimbursement For Y our T esting Supplies , Please Call 1-800-348-8100.
Intr oduction What it is: The Ascensia E LITE ™ Diabetes Care System is a blood glucose monitoring system. The system is made up of the Ascensia E LITE ™ Meter , T est Strip, and Code Strip. For quality control of the system, the Ascensia E LITE ™ Check Strip and Normal, Low and High Controls are also available.
12 8 9 6 7 5 1 2 3 TESTING MA TERIALS 4 11 10.
i T est Slot – provides an opening for inserting strip into the Meter . Icon – shows proper orientation and direction for inserting the T est Strip, Code Strip or Check Strip into the Meter . Display – displays test results, current Code (Function) Number (F– #), or low battery indicator .
ii Intr oduction ( continued) What you do: 1. Insert the T est Strip into the T est Slot located at the top, center of the Meter . 2. T ouch the test end (tip) of the T est Strip to a drop of blood. A “beep” sounds after the T est Strip reaction chamber is filled with blood.
iii Special Featur e 1. WHA T IS DIFFERENT ? The part of the T est Strip that touches the sample. 2. HOW IS IT DIFFERENT ? The blood sample is drawn into the T est Strip and is not put on the T est Strip.
iv 4. IN O THER WORDS: Think of the T est Strip as a straw used for drink- ing. Y ou put the straw into the liquid. The liquid is drawn into the straw at one end... SO the blood sample is drawn into the T est Strip at one end when you put the tip of the T est Strip into the sample.
v Contents SECTION 1 – The Ascensia E LITE ™ Diabetes Care System • Learn About the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 • Install/Replace Batteries . . . . . . . . . . . . . . . . . . . . . . . . . .
vi Contents ( continued) SECTION 4 – Learn About the Memory Feature • Introduction to Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 • Recall T est Results from the Memory . . . . . . . . . . . . . . . . . . . .
1 Lear n About the System SECTION 1 This booklet is designed to guide you through the operation of the Ascensia E LITE ™ Diabetes Care System with detailed directions and illustrations. A Quick Reference Guide is provided, and can be carried in your Meter Carrying Case.
2 Install / Replace Batteries SECTION 1 THE BA TTERIES: The Meter uses two (3-volt lithium) batteries. These are furnished with the Meter . WHEN TO REPLACE: When the battery voltage becomes weak (after approximately 1 000 readings), the Meter will show a battery display ( ) .
3 Check the Meter Performance SECTION 1 WHEN: When your Meter is new and anytime you want to check that your Meter is functioning properly . WHA T TO EXPECT : A Check Strip test result that falls within the Check Strip Range tells you that the Meter electronics are working properly .
Insert the Check Strip fully into the Meter as shown (with tab pointing right). A beep sounds and a full display* appears. Another beep sounds and the Check Strip test result is dis- played. A check mark ( ✔ ) shows on the display when the Check Strip test is done.
5 If the Check Strip test result is within the range listed on the package insert found inside the Check Strip package, the Meter is functioning properly . If not, refer to the Problem Solving Chart in Section 6. Carefully remove the Check Strip from the Meter , and replace it in its package.
6 Code (Calibrate) the Meter SECTION 2 WHY CODE THE METER? T o match the Meter to the reactivity of the T est Strip, you must first code (calibrate) the Meter using the Code Strip provided in the carton of Ascensia E LITE ™ T est Strips now in use.
7 MA TERIALS REQUIRED: • Ascensia E LITE ™ Meter • Ascensia E LITE ™ Code Strip CODE THE METER: 1 Open your new carton of T est Strips and find the clear plastic packet contain- ing the Code Strip. 2 Carefully tear open the packet, and remove the Code Strip.
8 3 Insert the Code Strip into the T est Slot (as shown). A beep sounds and a full display appears briefly . Another beep sounds and the Function Number (for exam- ple, F-4) appears in the Display . Things to remember: • It is important to insert the Code Strip with a firm motion until it comes to a full stop.
9 The Contr ol T est SECTION 2 T o make sure your Ascensia E LITE ™ Diabetes Care System is performing properly , a Control T est is performed using the Ascensia E LITE ™ Normal Control solution. WHY? A Control T est confirms that the system is functioning properly and you are using proper technique.
10 MA TERIALS REQUIRED: • Ascensia E LITE ™ Meter • Ascensia E LITE ™ Normal Control Solution • Ascensia E LITE ™ Te s t Strip and Code Strip • CLINILOG ® Diary PREP ARE FOR TEST : If not already done, code your Meter using the Code Strip (see page 7).
11 3 Remove the T est Strip from packet. Holding the round end, insert the strip fully into the Meter . NOTE: Save the empty foil packet for use in Step 6. 4 A beep sounds and a full display appears, followed by the Function Number (F#) and the previous test result.
12 6 Gently squeeze a small drop of Control solution onto the inside of the foil you saved in Step 3. 7 T ouch and hold the TEST END of the T est Strip in the drop until after the Meter beeps. A small amount of Control solution is auto- matically drawn into the T est Strip.
13 FOLLOW UP: Record and date all Control T est results in your CLINILOG Diary . CAUTION: If the Control T est result does not fall within the stated range, the system may not be operating prop- erly . See Section 6 of this User Guide and the Ascensia E LITE ™ Control package insert for help.
14 MA TERIALS REQUIRED: • Ascensia E LITE ™ Meter • Ascensia E LITE ™ Te s t Strip and Code Strip • MICROLET ® Adjustable Lancing Device/Lancet - Tissue or cotton ball for wiping finger after testing • CLINILOG ® Diary PREP ARE FOR TEST : If not already done, code your Meter using the Code Strip (see page 7).
15 2 Wash your hands. Use warm soapy water . Rinse and dry thoroughly . 3 Remove foil packets from carton and tear off single packet. 4 T o open the T est Strip packet, carefully peel the foil until the T est Strip is completely exposed (as shown).
16 5 Remove T est Strip from packet. Holding the round end, insert the strip fully into the Meter . NOTE: Be sure to save the foil to use when disposing of the T est Strip. 6 A beep sounds and a full display appears, followed by the Function Number (F#) and the previous test result.
17 1 Stick your finger with the MICROLET Adjustable Lancing Device and form a small drop of blood. Perform the Blood Glucose T est SECTION 3 Note: Multiple Site T esting Consult with your healthcare professional prior to testing from a site other than your fingertips.
4 If you want to store the test result, remove the T est Strip from the Meter as shown. The Meter turns off automatically and the test result is now stored in the memory . Y ou may wish to use a tissue or the foil wrapper from the strip to remove the used strip.
19 5 If you do not want to store the test r esult in the memory , pull out the T est Strip and quickly insert it back into the Meter (within 2 seconds).
20 Perform the Blood Glucose T est ( continued) SECTION 3 Things to remember: • Never use a T est Strip beyond the printed expiration date (on the foil packet). • Use the T est Strip immediately after removing fr om the foil packet. • It is important to insert the T est Strip until it comes to a full stop.
21 Intr oduction to Memory SECTION 4 This section will instruct you on the use of the Ascensia E LITE ™ Meter’ s memory feature. The following questions and answers should help you learn about this feature.
22 Intr oduction to Memory ( continued) SECTION 4 Can I delete test results? Y es, you can delete either all of the test results stored in the memory , or a single test result before it goes into the memory .
23 1 Insert the Check Strip fully into the Meter as shown. NOTE: If your Check Strip is not available, you can use a new T est Strip for this procedure. However , you have to wait 3 minutes for the memory sequence to begin. 2 A beep sounds and a full display appears briefly .
24 1 Insert the Check Strip fully into the Meter . Wait 10 seconds for the memory sequence to begin. NOTE: Y ou may also use a T est Strip to delete all test results from memory . However , you must wait 3 minutes for the memory sequence to begin. When you see the memory sequence begin, proceed to Steps 2 and 3.
25 1 A test result may be deleted at the end of a test during the 3 minutes it is displayed. Use a tissue to pull out the T est Strip and quickly insert it back into the Meter (within 2 seconds). NOTE: Single test results can only be deleted at the end of a test.
26 1 T o prevent the Control results from being included in the average, you should mark each Control T est with a “C.” This must be done before performing the Control T est. First, insert the T est Strip fully into the Meter . 2 A beep sounds and a full display appears briefly .
27 Things to Remember About the Memory SECTION 4 Recall T est Results from the Memory (see page 23) • Low (below 20 mg/dL [1 . 1 mmol/L]) and high (above 600 mg/dL [33.3 mmol/L]) test results are displayed and stored in memory as Lo and Hı. In calculating the aver- age, Lo is entered as 20 mg/dL (1 .
28 Things to Remember About the Memory ( continued) SECTION 4 Mark a Control T est Result (see page 26) 1. Y ou should “mark” your Control T est results with a “C” before storing them in the memory . This prevents the Meter from averaging your Control T est results in with your blood glucose results.
29 Car e of the Meter and Strips SECTION 5 1. T o help keep the Meter and T est Strips free of oils and other contaminants, wash hands and dry thoroughly before using. 2. Handle the Meter carefully . Dropping may damage the electronics or cause other malfunctions.
30 Car e of the Meter and Strips ( continued) SECTION 5 W ARNING: Potential Biohazard: Healthcare professionals or persons using this system on multiple patients should be aware of the following and should follow the infection control procedure approved by their facility .
31 Meter and T est Strip Pr oblems SECTION 6 E-1 E-2 display E-4 Display goes blank after T est, Code or Check Strip is inserted into the Meter . The Function Number displayed is different from the number print- ed on the T est Strip foil packet or carton.
32 Meter and T est Strip Pr oblems (continued ) SECTION 6 Meter fails to start countdown. Some display seg- ments do not appear . Battery display . 1. Blood applied wrong; see pp. iii, iv . 2. T est Strip inserted incorrectly . 3. Sample is applied while full display is showing .
33 T est Result Pr oblems SECTION 6 “Lo” display . “Hı” display . 1. The blood glucose value may be below 20 mg/dL (1 . 1 mmol/L). 2. T est Strip not filled completely . 3. T est Strip is defective or has deteriorated. 4. Wrong Function Number used.
34 T est Result Pr oblems (continued ) SECTION 6 IMPORT ANT : T o have accurate test results, sufficient sample to fill the reaction chamber is needed. The following drawings show how a T est Strip looks when filled and not filled. 1. Rerun test with new T est Strip and apply sufficient sample to fill T est Strip.
35 Service SECTION 7 If attempts to correct a problem fail, please call our Customer Service Department. W e have trained specialists to assist you. In the U.S.A., call toll free at: 1 - 800 - 348 - 8100 IMPORT ANT : • Speak to a Customer Service Representative before returning your Meter for any reason.
36 Check List SECTION 7 1. The Meter serial number is: 2. The date and time the problem occurred was: 3. I tested with both the Check Strip and with the Ascensia E LITE ™ Normal control: • The Check Strip result was: • The Normal Control result was: 4.
37 Limitations of the Pr ocedur e SECTION 7 1. PRESERV A TIVES: • Fluoride – Do not use fluoride as a preservative for blood specimens. • Iodoacetic acid – Do not use iodoacetic acid as a preservative for blood specimens.
38 Specifications SECTION 7 T est Sample: Whole blood T est Result: Plasma/Serum glucose Reaction Chamber Sample V olume: 2 µ L Measuring Range: 20 – 600 mg/dL (1 .
39 3 Then quickly turn the Meter back over (display is blank), remove and r einsert strip within 10 seconds. on is displayed. Immediately pull the strip out within 2 seconds. off is dis- played. The alarm is now off. T o turn the alarm back on, repeat this procedure (# 1 -2-3).
40 Supplies SECTION 7 When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item. REPLACEMENT P ARTS ACCESSOR Y ITEMS Part Number* 40030.
41 Limited W arranty SECTION 7 Manufacturer’ s Warranty: Bayer Corporation (“Bayer”) warrants to the origi- nal purchaser that this instrument will be free from defects in materials and work- manship for 5 years from the date of origi- nal purchase (except as noted below).
42 W arranty ( continued) SECTION 7 BA YER MAKES NO OTHER EXPRESS WAR- RANTY FOR THIS PRODUCT . THE OPTION OF REPLACEMENT , DESCRIBED ABOVE, IS BA YER’S ONL Y OBLIGA TION UNDER THIS WARRANTY . IN NO EVENT SHALL BA YER BE LIABLE FOR INDIRECT , SPECIAL OR CONSEQUEN- TIAL DAMAGES, EVEN IF BA YER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
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