Bayer HealthCare Blood Glucose Meter MODEL Ascensia Elite manuale d’uso

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. How it works: The Ascensia E L[...]

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 . Batteries – provide power for the Meter . Check S[...]

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. The test result is displayed in 30 seconds. The Meter turns on when t[...]

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. 3. WHEN DOES THIS HAPPEN? The test end (tip) of the T est Strip draws (pulls) the blood sample into the T est Strip when the tip touches the bloo[...]

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. W e call this “Sip-in Sampling.” RIGHT WRONG[...]

v Contents SECTION 1 – The Ascensia E LITE ™ Diabetes Care System • Learn About the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 • Install/Replace Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 • Check the Meter Performance . . . . . . . . . . . . . . . . . . . . . .[...]

vi Contents ( continued) SECTION 4 – Learn About the Memory Feature • Introduction to Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 • Recall T est Results from the Memory . . . . . . . . . . . . . . . . . . . . . . . . . . 23 • Delete All 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. Please read the entire User Guide before you begin testing. Before reading th[...]

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 ( ) . When this display appears, it is time to replace the batteries (see page [...]

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 . Note the Check Strip Range printed on the check strip package ins[...]

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. 4 MA TERIALS REQUIRED: • Ascensia E LITE ™ Meter • Ascensia E LITE ™ Check[...]

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. Things to remember: • It is important to insert the Ch[...]

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. Each lot of T est Strips is tested extensively and assigned a Function Number (0 through 12) ident[...]

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. Save the packet to store the Code Strip. Code the Meter ( continued) SECTION 2[...]

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. When inserted fully , the tab on t[...]

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. When running a Control T est, the system is[...]

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). Also check to make sure the T est Strips and the Normal Control Solution have not [...]

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. The Function Number and the previous test result begin flashing alternately . If y[...]

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. The timer begins count- ing down from 29 seconds. The Contr ol T est ( cont[...]

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. Things to remember: • Run a Control T est fr equentl[...]

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). Also check to make sure [...]

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). NOTE: The numbers printed on each T est Strip are manu- facturing numbers and should not be confused [...]

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. The Function Number and the previous test result begin flashing a[...]

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. Blood glucose testing results from sites other than your fingertip could be si[...]

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. CAUTION: Dispose of the used T est Strip and lancet carefully to pr e- vent injury or c[...]

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). dEL appears in the Display , and the test result will not be stored in the memory . Do not pull the T est Strip out of the Meter until the Display goes blank, or the test result will not be deleted[...]

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. When inserted fully , the tab on the[...]

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. How many test results does the memory stor e? The memory stores up to 20 test results, and also provides the “average” of the Blood Glu[...]

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 . How will I know the differ ence between a stored Blood Glucose T est and a Control T est? A Control T est result in memory is preceded by a C[...]

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 . Another beep sounds and the Check Strip result is displayed. Recall T es[...]

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. 2 Pull out the Check Strip, and quic[...]

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. 2 dEL appears in the Display for 2 seconds and then the Meter turns off. NOTE: Do not [...]

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 . The Function Number and the previous test r esult begin flashin[...]

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 . 1 mmol/L), and Hı is entered as 600 mg/dL (3[...]

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. 2. Each Control T est result stored in m[...]

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. 3. Do not expose the Meter , T est Strip, Code Strip or Check Strip to excessive humi[...]

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 . All products or objects which come in contact with human blood, even after c[...]

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. Check Strip test result out-of-range. Meter electronics failur e. 1. Batteries are not instal[...]

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 . Meter electronics or battery failure. 1. Battery voltage low . 1. For[...]

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. 1. The blood glucose value may be above 600 mg/dL (33.3 mmol/L). 2. Same as #3 above. 3. S[...]

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. Hold TEST END to sample unti[...]

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. He/she will give you the information neede[...]

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. The Normal Control Range listed on the end flap of the T est Strip carton is: 5. The Funct[...]

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. 2. ARTERIAL SPECIMEN: Arterial specimens with pO 2 of >200 mmHg had a small bias (average of – 6%) on the Ascensia[...]

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 . 1– 33.3 mmol/L) Measuring Time: 30 Seconds Calibration Curve: Selected by use of the Code Strip Memory Feature: Stores last 20 test results T emperature Compensation: Automatic co[...]

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). The Display sequence is reversed, off appears first and then on. Speci[...]

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* 40030030 Item 3-volt Lithium Battery (DL or CR2032) – 2 (Available at most Camera Stores) 99M39019 50184221 Ascensia E LITE ™ User Guide Quick Referenc[...]

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). During the stated 5-year period, Bayer shall, at no charge, replace a [...]

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. S[...]