i-SENS CareSens II Owner's Booklet

i-SENS CareSens II Owner's Booklet

Blood glucose monitoring system
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i-SENS, Inc.
465-6 Wolgye4-dong, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80, D-66386
St. Ingbert, Germany
2012 i-SENS, Inc. All Rights Reserved. PGA1E3011 REVx 02/2012
©
Owner's Booklet

Blood Glucose Monitoring System

Accurate, complete blood glucose
monitoring through advanced
biosensor technology

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Summary of Contents for i-SENS CareSens II

  • Page 1: Blood Glucose Monitoring System

    Blood Glucose Monitoring System Accurate, complete blood glucose monitoring through advanced biosensor technology i-SENS, Inc. 465-6 Wolgye4-dong, Nowon-gu Seoul 139-845, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80, D-66386 St. Ingbert, Germany 2012 i-SENS, Inc. All Rights Reserved. PGA1E3011 REVx 02/2012 ©...
  • Page 2: Welcome To The Caresens Ii Blood Glucose Monitoring System

    Welcome to the CareSens II Blood Glucose Monitoring System Thank you for purchasing the CareSens II Blood Glucose Monitoring System. The system provides you with fast, safe, and convenient blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You will receive an accurate results in only five seconds with a...
  • Page 3: Table Of Contents

    Table of Contents Welcome to the CareSens II Blood Glucose Monitoring System Table of Contents Important Information: Read This First! CareSens II Blood Glucose Monitoring System CareSens II Blood Glucose Meter Meter Display Setting the Meter Setting the Month and Date...
  • Page 4: Table Of Contents

    Very high (60% or more) or very low (20% or less) hematocrit can lead to incorrect test results. The following chart explains the symbols you will find in the CareSens II User Manual, product packaging, and product inserts. If you need assistance, please contact your authorized i-SENS sales...
  • Page 5: Caresens Ii Blood Glucose Monitoring System

    • Helpful Tip See page 40 for battery information and replacement instructions. Use only CareSens Test Strips with the CareSens II Blood Glucose Monitoring System. • P lease contact your authorized i-SENS sales representative if any component is missing or damaged.
  • Page 6: Caresens Ii Blood Glucose Meter

    CareSens II Blood Glucose Meter Meter Display code Meter Display Shows code for three (3) seconds after Test result, symbol and simple message display. test strip insertion М Button On-off power button. Also used to call memory or setting modes.
  • Page 7: Setting The Meter

    Setting the Month and Date Setting the Meter When you turn on your CareSens II Meter [1] Setting the Month the first time, its display will show the Press and hold the M Button for three (3) following setting: seconds. A blinking number indicating the month will appear on the lower left display •...
  • Page 8: Setting The Time

    Setting the Time Setting the Year and Measurement Unit [6] Setting the Year [3] Setting the Time Press the C Button until correct year appears. The meter can be set in an AM/PM 12-hour After setting the year, press the M Button to or 24-hour format.
  • Page 9: Storing Test Results In Meter Memory

    Deleting Stored Test Storing Test Results in Meter Memory Results from Meter Memory The CareSens II Meter provides storage for up to 250 blood glucose test results. It also stores the To delete all past stored test results, follow this procedure.
  • Page 10: Checking The Meter With The Caresens Ii Check Strip

    CareSens II Check Strip The CareSens Test Strip supports the accurate measurement The CareSens II Check Strip is used to determine if the meter of glucose levels in a capillary whole blood sample. is functioning properly. To perform the test, start with the meter turned off.
  • Page 11: Coding Meter To Match Test Strips

    Coding Meter to Match Test Strips Warning! For accurate results, the code numbers on the CareSens II Meter • The CareSens test strip should be used only with fresh capillary and CareSens Test Strips must match. You must code your meter whole blood samples.
  • Page 12: Checking The System

    Checking the System Press the M or the C Button to select the CareSens Control Solution: correct code number. Each time you press You may check your meter and test strips using the the M button, the number will increase by CareSens Control Solution.
  • Page 13: Caresens Glucose Control Solution Storage And Handling

    Perform the following steps to check the combined performance test strips are working properly and you may use them for of your CareSens II Meter and Test Strips or to assess proper testing your blood glucose test. procedure performance.
  • Page 14: Comparing The Control Solution Test Results

    When the test strip is past its expiration date, you are ready to test your blood. • When the meter is not functioning properly. The CareSens Control Solution can be purchased separately. Please contact your authorized i-SENS sales representative. Remove used test strip. The Meter will turn off.
  • Page 15: Using The Lancing Device

    Blood Sample Retrieval You will need a lancing device in order to collect a blood sample. You may use the lancing device contained in the CareSens II Blood Glucose Monitoring System or any other medically approved Wash hands and fingertip sample lancing device.
  • Page 16: Using The Lancing Device At Fingertip Sample Site

    Using the Lancing Device at Fingertip Sample Site Select a desired depth of one-to-five (1-5) on lancing device’s adjustable Place cocked lancing device tip. Rotate ring to align desired against fingertip side. number with the arrow. A beginning setting of three (3) is recommended.
  • Page 17: Testing Your Blood Glucose Levels

    • Helpful Tip When testing from forearm, hold the meter as shown. If the test strip dose not receive a blood sample, please contact your authorized i-SENS sales representative. Meter will count down from five-to-one (5-1) on the display. Test results, time, and date will appear and automatically store in meter memory.
  • Page 18: Alternative Site Testing

    Alternative Site Testing What is AST (Alternative Site Testing)? The meter will automatically turn off if a sample is not applied within two (2) minutes. If this happens, remove the test strip Usually, when someone tests their glucose, they take the blood from the port.
  • Page 19 Things to know when using AST AST Precautions Please understand the following things before testing outside of the • Do not ignore the symptoms of hyperglycemia or fingertip (arms, thighs, calves). hypoglycemia. The capillary blood of the fingertip shows the change in glucose •...
  • Page 20: Discarding Used Lancets

    Discarding Used Lancets Target Blood Glucose Ranges Proper discarding of used lancets protects you and others from infection and injury. The following shows the correct process. Reminders Your target ranges Unscrew general lancing device tip. Time of day from your healthcare expert Before breakfast Before lunch or dinner 1 hour after meals...
  • Page 21: Hi And Lo Messages

    Caring for Your System Use a soft cloth or tissue to wipe the meter exterior. If necessary, The CareSens II Meter displays test results between 20 to 600 mg/dL (1. 1 -33.3 mmol/L). Please refer to the instructions the soft cloth or tissue might be dipped in a small amount of below if you receive a Hi or Lo message.
  • Page 22: Replacing The Batteries

    Specifications Replacing the Batteries When the icon appears on the display for the first time, the • Test Range: 20-600 mg/dL (1.1-33.3 mmol/L) battery should be replaced as soon as possible. • Sample Size: Minimum 0.5 ㎕ Use only non-rechargeable, replaceable, type CR2032 lithium •...
  • Page 23: Performance Characteristics

    Performance Characteristics The performance of CareSens II Blood Glucose Monitoring System Precision: Strips has been evaluated in laboratory and in clinical tests. Precision studies were performed in a laboratory using the Accuracy: CareSens II BGM Systems are calibrated to yield results CareSens II BGM System.
  • Page 24: Understanding Error And Other Messages

    Repeat test with a new strip. Temperature Take system recommended where temperature system range is within operating during test. range (10-40˚C/ 50-104˚F ) and repeat test after 30 minutes. If the error messages persist, contact your authorized i-SENS sales representative.
  • Page 25: General Troubleshooting

    • Check whether the test strip is inserted with the contact i-SENS, Inc. warrants that the CareSens II Meter shall be free of bars facing up. Check if the strip has been inserted defects in material and workmanship in normal use for a period completely till the end.
  • Page 26 MEMO...

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