Bayer HealthCare Ascensia Elite XL manual

THE NEW FACE of Glucometer ® Diabetes Care System U SER G UIDE F or Use W ith Ascensia E LITE ™ XL Blood Glucose Meter Need Help with Reimbursement? Call Our Bayer Care Help Line: 1-877-787-1912[...]

2 The Meter ii T est end Meter end T est Strip Icon Button Display T est slot[...]

T esting Materials 2 iii • Ascensia E LITE ™ T est Strip – use for blood or control testing. Insert into Meter before drawing in blood or control sample . • Ascensia E LITE ™ Check Strip – use to check if the Meter is working properly before running a blood glucose test. • Ascensia E LITE ™ Code Strip – use to set the Meter (calib[...]

iv • T wo-step testing process: 1. Insert T est Strip in Meter 2. T ouch TEST END to blood • T est results are displayed in 30 seconds . • Meter turns on when inserting a strip and turns off when remov- ing the strip . • Up to 120 test results may be stored in the Meter and can be recalled when necessary . • Stored results may be transfer[...]

1 What do I do first? If needed, install batteries and set the time — test the Meter electronics with a Check Strip — code the Meter to match Ascensia E LITE T est Strips — and then run a control test to test the whole system before running a blood glucose test. What does blood glucose monitoring do for me? Blood glucose levels change during[...]

2 Important Information 2 • T he Ascensia E LITE ™ XL Blood Glucose Meter has been designed for use with Ascensia E LITE ™ T est Strips . T he perfor- mance characteristics of the Meter may not be valid for any other brand of T est Strips . T he use of other T est Strips may cause erroneous results . Bayer Corporation does not warrant the use[...]

User Guide Contents 2 3 SECTION P AGE Set Up For T esting 1 Install Batteries 4 2 Set the Alarm, Time and Units 5 3 Check Strip T est 6 4 Code the Meter 7 5 Control T est 8 T esting 6 Blood Glucose T est 11 7 Important to Remember 15 T est Result Management 8 Stored T est Results 17 9 Data Management 18 T aking Care 10 Meter and T est Strip Care 19[...]

SECTION 1 Install Batteries 4 1. Press firmly on “open” arrow and slide forward in the direc- tion of the arrow . The lid releases . 2. Place new batteries into the bat- tery compartment with the “+” side up . Slide lid back into place , lining up with open slots , and close firmly . T est results stored in the memory are not erased when [...]

SECTION Set the Alarm, Time and Units 2 5 Some Meter options may need to be reset when the Meter is new and when batteries are changed. The options may be changed any time to fit your needs. How do I set the Meter? Hold the button for five seconds to place Meter in “set up” mode . Press the button to change item as it flashes (you have five[...]

SECTION 3 Check Strip T est 6 Check your Meter when new or any time after use, to make sure that electr onics are working pr operly . HOW : 1. Remove the Check Strip from the package (save the package). 2. Insert the Check Strip (“check” side up) fully into the Meter until you hear a beep . A full display* shows , followed by another beep and t[...]

SECTION Code the Meter 4 7 Code the Meter whenever a new box of T est Strips is opened. * This will match the Meter to the T est Strip reactivity . HOW : Y ou will need the Code Strip found in the new box of strips . 1. T ear open the packet found in the new carton of T est Strips and remove the Code Strip (save the pack et). 2. Insert the Code Str[...]

SECTION 5 Control T est 8 Prepare for the T est: 1. T o open the T est Strip foil pack et, carefully peel the foil back until the T est Strip is completely exposed (as shown). Save the foil pack et. Note: Numbers printed on each T est Strip are manufacturing numbers and are not to be confused with Code Numbers (F#). 2. Holding the round end of the [...]

SECTION Control T est 5 9 T ak e the T est: 5. Squeeze a small drop of Control Solution onto the inside of the foil pack et you saved. 6. T ouch and hold the TEST END of the T est Strip to the drop until the Meter beeps (the Control Solution has now been drawn into the T est Strip). The timer begins to count down from 29 seconds . T he test result [...]

SECTION 5 Control T est 10 If you did not mark your control or want to delete the test result, do one of the following options before removing the strip . Remember , after marking or deleting, the test result will then not be a part of the blood glucose test average and will be stor ed in the memory and displayed with “CONT” or “DEL ”. Mark[...]

SECTION Blood Glucose T est 6 11 What does blood glucose monitoring do for me? Blood glucose levels change during the day due to medication, exercise , diet, insulins or hypoglycemics (oral agents) or possibly stress and illness . Blood glucose testing provides information that will help you understand the changes . T his information can help you m[...]

SECTION 6 Blood Glucose T est 12 Y ou need a Meter and T est Strip . T ak e the T est: 1. After washing your hands with warm soapy w ater and drying thoroughly , open a foil pack et and remove the T est Strip . 2. With the Meter off , hold the round end and insert the T est Strip fully into the Meter . Y ou will hear a beep . 2. After a full displa[...]

SECTION Blood Glucose T est 6 13 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 significantly different. T hese differences may vary from indi- vidual to individual, and are physiological d[...]

SECTION 6 Blood Glucose T est 14 T est Results: After 29 seconds , your test result is displayed. Do not remove strip until results are displayed. Record the test result/date in your Clinilog Diary . * Remove the T est Strip . T he Meter turns off and the test result is stored. *If you do not want to store the test result — befor e remov- ing T e[...]

SECTION Important to Remember 7 15 DON’T FORGET— when using the Meter: • Insert the Check Strip , Code Strip or T est Strip with a firm motion until it comes to a full stop . • T he tab on the strip can no longer be seen if the T est Strip has been inserted fully into the Meter . • T he Meter turns off automatically after 3 minutes if st[...]

SECTION 7 Important to Remember 16 DON’T FORGET— when using the Meter (cont.): • When the Meter memory is full and a new test result is entered, the oldest result is deleted (i.e., #1). • T each another person how to use the system, so you will have someone to help if you ever need assistance . DON’T FORGET— when using a T est Strip: ?[...]

How to recall test r esults: 1. Press the button to turn Meter on. After a full display and year , the current date and time are displayed. T he 14-day average then appears with “MEM” (memory) and “ A ” (average) in the lower left corner . T he average result displayed is the average of all blood test results obtained within the last 14 day[...]

SECTION 9 Data Management 18 • Use Win Glucofacts ™ XL Diabetes Management Software . • Y our Meter can transfer test results to a computer where results can be electronically summarized in a logbook report, graph, or chart. • T o make use of this feature , you need special softw are and a connecting cable . • F or more information relati[...]

19 SECTION Meter and T est Strip Care 10 • W ash hands and dry thoroughly before testing to k eep the Meter and T est Strips free of oils and other contaminants . • Handle the Meter carefully to avoid damaging the electronics or causing other malfunctions . • Avoid exposing Meter and T est Strip to excessive humidity , heat, cold, dust, or di[...]

SECTION 10 W arning: P otential Biohazard 20 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 cleaning, should be handled as if capable o[...]

SECTION Meter and T est Strip Problems 11 MESSAGE CA USE SOLUTION See the possible solutions listed and if you need further assistance , contact Bayer Customer Service at: 1-800-348-8100 (24 hours a day) E-1 E-3 display E-4 E-2 display Meter electronics failure . Meter below or above operating tempera- ture, 50°–104° F (10°– 40° C). Immedia[...]

SECTION 11 Meter and T est Strip Problems 22 MESSAGE CA USE SOLUTION Meter fails to start countdown. 1. Blood applied wrong; see page 12. 2. T est Strip inserted incorrectly . 3. Meter turned on before T est Strip inserted. 4. Sample is applied while full display is showing. Some display seg- ments do not appear . Meter electronics or battery failu[...]

SECTION Meter and T est Strip Problems 11 23 MESSAGE CA USE SOLUTION “Lo” display . CAUTION: Glucose levels below 50 mg/dL (2.8 mmol/L) may indicate a potentially serious medical condition. 1. T he 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. [...]

SECTION 11 Meter and T est Strip Problems 24 MESSAGE CA USE SOLUTION Blood glucose or Control T est results are inconsistent, or Control T est results are not within the specified range . 1. Not enough blood or Control Solution is drawn into the T est Strip . 2. T est Strips and/or Control Solution products have passed their expiration date . 3. D[...]

SECTION Service 12 25 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 informa- tion needed to get your problem handled correctly and efficiently . • Have your Ascensia E LITE ™ XL Meter , Ascensia E LITE ™ Check Strip , and a box of Ascensia E LITE[...]

SECTION 12 Service 26 Check List 1. T he Meter serial number is: ___________________ 2. T he date and time the problem occurred was: ___________________ 3. I tested with both the Check Strip and with the Ascensia E LITE ™ Normal Control: Y es____No____ • The Check Strip result w as: ___________________ • The Normal Control result w as: ______[...]

SECTION Limitations of the Procedure 13 27 1. PRESERV A TIVES: • Fluoride – Do not use fluoride as a preservative for blood specimens . • Iodoacetic acid – Do not use iodoacetic acid as a preserv ative for blood specimens . 2. ARTERIAL SPECIMEN: Arterial specimens with pO 2 of >200 mmHg had a small bias (average of – 6%) on the Ascens[...]

SECTION 14 Specifications 28 T est Sample: Whole blood T est Result: Plasma/serum glucose Reaction Chamber Sample V olume: 2 ␮ 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 Featur e: Stores last 120 test results T emperature Compensation: Automatic c[...]

SECTION Supplies 15 29 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 Part Number* Item 40030030 3-volt Lithium Battery (DL or CR2032) – 2 (Available at most Camera Stores) 99C38839 Ascensia E LITE ™ XL User Guide 50184228 Quick Reference Guide 50062[...]

SECTION 15 Supplies 30 ACCESSOR Y ITEMS Product Code Number Item 3870A Ascensia E LITE ™ T est Strips – 50’ s (Medicare patient use only) 3871A Ascensia E LITE ™ T est Strips – 50’ s (mail order only) 3873A Ascensia E LITE ™ T est Strips – 50’ s (professional use only) 3911A Ascensia E LITE ™ T est Strips – 25’ s 3918A Ascen[...]

SECTION W arranty 16 31 Manufacturer’ s Warr anty: Bayer Corporation (“Bayer”) warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original pur- chase (except as noted below). During the stated 5-year period, Bayer shall, at no charge, replace a unit found[...]

SECTION 16 W arranty 32 BA YER MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT . THE OPTION OF REPLACEMENT , DESCRIBED A BOV E, IS BA YER’S ONL Y OBLIGA TION UNDER THIS W ARRANTY . IN NO EVENT SHALL BA YER BE LIABLE FOR INDIRECT , SPECIAL OR CONSEQUENTIAL DAMA GES , EVEN IF BA YER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMA GES . Some state[...]