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i-SENS, Inc.
465-6 Wolgye4-dong, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
© 2012 i-SENS, Inc. All Rights Reserved PGB6E3001 REV4x 02/2012
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80, D-66386
St. Ingbert, Germany
0123

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Summary of Contents for i-SENS e-Checker

  • Page 1 Medical Technology Promedt i-SENS, Inc. Consulting GmbH, 465-6 Wolgye4-dong, Nowon-gu Altenhofstrasse 80, D-66386 Seoul 139-845, Korea St. Ingbert, Germany www.i-sens.com 0123 © 2012 i-SENS, Inc. All Rights Reserved PGB6E3001 REV4x 02/2012...
  • Page 2: Welcome To The E-Cheker

    Welcome to the e-CheKer Blood Glucose Monitoring System Thank you for your purchase of the e-CheKer Blood Glucose Monitoring System. The system provides you with convenient, safe and less painful blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You'll receive an accurate result in only five seconds with a small (0.5 ㎕) blood sample.
  • Page 3: Table Of Contents

    Table of Contents Welcome to the e-CheKer Blood Glucose Monitoring System Table of Contents Important Information: Read This First! e-CheKer BGM System Components e-CheKer Blood Glucose Meter Meter Display Setting the Meter Setting the Month and Date Setting the Time Setting the Year and Measurement Unit Setting the Sound On/OFF Storing Test Results in Meter Memory...
  • Page 4: Table Of Contents

    The e-CheKer meter detects this electrical current and measures the amount of glucose in the blood sample. • If you need assistance, please contact your authorized i-SENS sales representative or visit www.i-sens.com for more information.
  • Page 5: E-Cheker Bgm System Components

    Test Strip. ⑤ Lancing Device Solution Please contact your authorized i-SENS sales representative if any component is missing or damaged. Helpful Tip See page 17 for battery information and replacement instructions. Use only e-CheKer Test Strips with the e-CheKer...
  • Page 6: Meter Display

    Meter Display Setting the Meter When you turn on your e-CheKer Meter the first time, press and hold the M button for three (3) seconds to set the display. check Appears during meter Shows previously • Display format for the date: MM-DD testing.
  • Page 7: Setting The Time

    Setting the Meter Step 2 Step 5 Setting the Date Setting the Minute Press C button until blinking number Press C button until correct minute represents correct date. appears. After minute is set, press M button to move to year setting mode. Press M button to set and move to time setting mode.
  • Page 8: Setting The Sound On/Off

    Storing Test Results in Meter Memory Setting the Meter The e-CheKer Meter provides storage for up to 250 blood glucose Step 8 test results. It also stores the 14-day average and number of tests Setting the Sound On/OFF performed. The following procedure lets you store your test results.
  • Page 9: Deleting Stored Test Results From Meter Memory

    Deleting Stored Test Results from Meter Memory e-CheKer Blood Glucose Test Strip To delete all past stored test results, follow this procedure. The e-CheKer Test Strip supports the accurate measurement of glucose levels in a capillary whole blood sample. Step 1 Begin with meter off.
  • Page 10: Test Strip Storage And Handling

    • Do not reuse test strips. Please do not attempt to remove it by force. If this happens, and Correct position of the contact the i-SENS representative battery. (The”+” side is Helpful Tip not visible.) in your area.
  • Page 11: Coding Meter To Match Test Strips

    Coding Meter to Match Test Strips For accurate results, the code numbers on the e-CheKer Meter Step 3 and e-CheKer Test Strips must match. You must code your meter Press M or C button to select the before using it for the first time and each time you open a new correct code number.
  • Page 12: Meter And Test Strip Performance Check

    Control Solution to test e-CheKer Test Strips and the • Believe your test results are not accurate. e-CheKer Meter. • Suspect your meter and test strips are not performing properly. e-CheKer Control Solution is sold separately. Contact your authorized i-SENS sales representive for more information.
  • Page 13: Testing Meter And Test Strip Performance

    Testing Meter and Test Strip Performance Testing Meter and Test Strip Performance Perform the following steps to check the combined Step 3 performance of your e-CheKer Meter and Test Strips or to assess Test results appear after the meter proper testing procedure performance. counts down from five-to-one (5-to-1).
  • Page 14: Out Of Range Result Factors

    Test Strip and e-CheKer Meter may not be working together properly. If so, do not use your system, please contact your authorized i-SENS sales representative. • The lancing device should be used by one individual and communal use is strongly discouraged.
  • Page 15: Preparing The Lancing Device For Blood Sample Retrieval

    Preparing the Lancing Device for Blood Sample Preparing the Lancing Device for Retrieval Blood Sample Retrieval Step 1 Step 4 Select a desired depth of one-to- Wash hands and fingertip sample site five (1-5) on the lancing device’s with soap and warm water. adjustable tip.
  • Page 16: Using The Lancing Device At Fingertip Sample Site

    Using the Lancing Device at Fingertip Testing Your Blood Glucose Level Sample Site Step 1 Step 1 Insert the test strip with contact bars facing up into the port. Push the strip Place cocked lancing device gently until meter beeps. The code against fingertip side.
  • Page 17: Testing Your Blood Glucose Level

    Helpful Tip If the test strip does not receive a blood sample, please contact Discard used test strips and lancets properly in a your authorized i-SENS sales representative. container for sharp objects.
  • Page 18: Alternative Site Testing

    Alternative Site Testing Alternative Site Testing What is AST (Alternative Site Testing)? Things to know when using AST Usually, when someone tests their glucose, they take the blood Please understand the following things before testing outside sample from the tip of the finger. However, since there are of the fingertip (forearm, palm, thigh, and calf ).
  • Page 19: Discarding Used Lancets

    Discarding Used Lancets Proper discarding of used lancets protects you and others from AST Precautions infection and injury. The following shows the correct process. • Do not ignore the symptoms of hyperglycemia or hypoglycemia. Step 1 • When the results of the test do not reflect one’s opinion, retest Unscrew lancing device tip.
  • Page 20: Target Blood Glucose Ranges

    If you receive a Hi or Lo message, repeat the test. If the result is the same, contact your physician immediately. If Hi or Lo message does not reflect how you feel, contact your authorized i-SENS sales representative.
  • Page 21: Reading Variation Factors

    Reading Variation Factors Caring for the Meter An abnormally high or low red blood cell count(hematocrit Use a soft cloth or tissue to wipe the meter exterior. levels over 60% or below 20%) may produce inaccurate results. If necessary, a small amount of alcohol on a soft cloth or tissue may be used.
  • Page 22: Performance Evaluation

    e-CheKer Blood Glucose Performance Evaluation Monitoring System Specifications The performance of e-CheKer Blood Glucose Monitoring System Strips has been evaluated in laboratory and in clinical tests. • Test Range: 20-600 mg/dL (1.1-33.3 mmol/L) • Sample Size: Minimum 0.5 ㎕ Accuracy: The accuracy of the e-CheKer BGM System (Model GM505FA) was assessed by comparing blood glucose results •...
  • Page 23: Error Messages And Troubleshooting

    Performance Evaluation Error Display Messages and Troubleshooting Message Possible Cause Solution Precision: Precision studies were performed in a laboratory using the e-CheKer BGM System. Test strip has been Use a new strip. Within Run Precision used. Blood average 39.5 mg/dL (2.2 mmol/L) SD=1.2 mg/dL (0.07 mmol/L) Blood average...
  • Page 24: General Troubleshooting

    • Make sure sample was applied in time. Repeat test with new test strip. • Draw sample from another fingertip or alternate site. Repeat test with a new test strip. Contact your authorized i-SENS sales representative if error messages persist after following above actions.
  • Page 25: Warranty Information

    Warranty Information MEMO Manufacturer’s Warranty i-SENS, Inc. warrants that the e-CheKer Meter shall be free of defects in material and workmanship in normal use for a period of five (5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter.
  • Page 26 MEMO MEMO...
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