i-SENS CARESENS DUAL Owner's Booklet
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i-SENS CARESENS DUAL Owner's Booklet

Blood glucose monitoring system
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www.i-sens.com/smartlog
i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu,
Seoul 06646, Korea
www.i-sens.com
© 2016 i-SENS, Inc. All Rights Reserved. PGL6E2202 REV1 07/2016
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80, D-66386
St. Ingbert, Germany
Owner's Booklet
Blood Glucose Monitoring System
Blood β-Ketone Monitoring System

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Summary of Contents for i-SENS CARESENS DUAL

  • Page 1 Blood β-Ketone Monitoring System code for easy access). www.i-sens.com/smartlog i-SENS, Inc. Medical Technology Promedt 43, Banpo-daero 28-gil, Seocho-gu, Consulting GmbH, Altenhofstrasse 80, D-66386 Seoul 06646, Korea www.i-sens.com St. Ingbert, Germany © 2016 i-SENS, Inc. All Rights Reserved. PGL6E2202 REV1 07/2016...
  • Page 2 • The information in this manual is correct at the time of printing. automatically communicate with each other when the However, i-SENS reserves the right to make any necessary changes at any Bluetooth feature is activated. time without notice as our policy is one of continuous improvement.
  • Page 3 Trademarks The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by i-SENS, Inc. is under license. All other trademarks and trade names are those of their respective owners. Note: The SmartLog mobile app may not be compatible with all smartphones.
  • Page 4 CareSens Dual Blood Glucose/Blood β-Ketone...
  • Page 5 Fresh venous whole blood drawn by healthcare professionals • The CareSens Dual Blood Glucose/Blood β-Ketone Meter can be used only for testing blood glucose. CareSens Dual Blood should only be used with CareSens PRO blood glucose and Glucose/Blood β-Ketone Monitoring System should be used KetoSens β-ketone test strips.
  • Page 6 • Operating channels: 40 channels Measurement range 0.1–8.0 mmol/L • Security encryption: 128-bit AES Sample size Minimum 0.5 μL (Advanced encryption standard) Test time 8 seconds Relative humidity 10–90% Sample type Fresh capillary whole blood Temperature 15–30˚C (59–86˚F) Hematocrit 30–60% 8 www.i-sens.com www.i-sens.com 9...

  • Page 7: Inserting Or Replacing The Batteries

    CareSens Dual Blood Glucose/Blood β-Ketone Monitoring System Inserting or Replacing the Batteries CareSens Dual System includes the following items: The CareSens Dual meter uses two 3.0 V lithium batteries. Before * CareSens Dual Blood Glucose/Blood β-Ketone Meter using the meter, check the battery compartment and insert * Owner's Booklet batteries if empty.

  • Page 8: Caring For Your System

    CareSens PRO Blood Glucose Test Strip Use a soft cloth or tissue to wipe the meter exterior. If necessary, The CareSens Dual Blood Glucose Monitoring System measures dip the soft cloth or tissue in a small amount of alcohol. blood glucose quickly and accurately. It automatically absorbs Do not use organic solvents such as benzene or acetone, or the small blood sample applied to the narrow edge of the strip.
  • Page 9 KetoSens Blood β-Ketone Test Strip • Do not reuse test strips. The CareSens Dual Blood β-Ketone Monitoring System measures blood β-ketone quickly and accurately. It automatically absorbs • Do not use test strips past the expiration or discard date. the small blood sample applied to the narrow edge of the strip.
  • Page 10 Note: • The cable for data management software can be ordered separately. Please contact your authorised i-SENS sales Caution: representative. • Keep the meter and testing supplies away from young • The unit of measurement is fixed and it cannot be changed children.

  • Page 11: Setting Up Your System

    CareSens Dual Meter Display Setting Up Your System Press and hold the for 3 seconds to enter the SET Mode. Test results After all settings are finished, press and hold the button for 3 Memory recall mode : appears when test seconds to turn off the meter.
  • Page 12 'PAIr' . PIN on your meter screen. On your smartphone, Meter's ID launch the SmartLog mobile app and select 'more' at the bottom of the screen. Select 'Meter Connection'  'Bluetooth'  'Search' . 20 www.i-sens.com www.i-sens.com 21...

  • Page 13: Adjusting The Date And Time

    Note: Some smartphones, especially those that are not tested or approved by i-SENS, may be incompatible with your meter. Visit www.i-sens.com/smartlog for more information about supported smartphones. You can also scan the QR code on the back cover of this user manual.

  • Page 14: Setting The Sound On/Off

    Press the ◀ or ▶ button until the correct step. minute appears. After setting the minute, press the button to go to the next step. Note: symbol is displayed only when the sound is set to OFF. 24 www.i-sens.com www.i-sens.com 25...
  • Page 15 If the expiration date is set to Caution: October of 2019, the meter Ask your healthcare professional to help you decide what your will display EP at the start of hypoglycemia level is before setting your level. November, 2019. 26 www.i-sens.com www.i-sens.com 27...

  • Page 16: Setting The Strip Expiration Date Indicator

    Press button until the correct month appears. Press and hold the button for 3 seconds to Caution: confirm the month and turn off the meter. Ask your healthcare professional to help you decide what your hyperglycemia level is before setting your level. 28 www.i-sens.com www.i-sens.com 29...

  • Page 17: Checking The System

    KetoSens Control Solution range printed on the test strip box. Before using a new meter or a new box of test strips, you may conduct a control solution test following the procedure on pages 32–33. 30 www.i-sens.com www.i-sens.com 31...

  • Page 18: Control Solution Testing

    Control Solution only. It has nothing to do with your blood strip until the meter beeps. Make sure the confirmation window glucose or your blood β-ketone levels. fills completely. 32 www.i-sens.com www.i-sens.com 33...

  • Page 19: Using The Lancing Device

    Repeated puncturing at the same sample site may cause pain meter may not be working properly. Do not use your system or skin calluses (thick hard skin). Choose a different and contact i-SENS sales representative. site each time you test. 34 www.i-sens.com...

  • Page 20: Preparing The Lancing Device

    The skin depth to get blood samples will vary for various with the load confirmation window and people at different sample sites. The lancing device's release button as shown. adjustable tip allows the best depth of skin penetration to get an adequate sample size. 36 www.i-sens.com www.i-sens.com 37...

  • Page 21: Preparing The Meter And Test Strip

    2 minutes of the symbol appearing on the screen. If sites are on the middle or ring fingers. the meter turns off, remove the strip and reinsert it, and start Press the release button. from Step 2. 38 www.i-sens.com www.i-sens.com 39...
  • Page 22 If you do not want to add any flags on the test result, remove the strip after the test result is displayed. When you test your blood β-ketone, there is no need to attach any flag. Blood β-ketone test result No flag Pre-meal flag Post-meal flag Fasting flag 40 www.i-sens.com www.i-sens.com 41...

  • Page 23: Discarding Used Lancets

    Then press the release button while continuing to apply Always dispose of lancets properly. pressure. Keep holding the lancing device against your skin until sufficient (at least 0.4 μL, actual size: ) blood is drawn. Carefully lift the lancing device away from your skin. 42 www.i-sens.com www.i-sens.com 43...
  • Page 24 • When insulin has the biggest effect with hair or with a line in your palm, do not use that sample. • During two (2) hours after an insulin injection Try puncturing again in a smoother area. 44 www.i-sens.com www.i-sens.com 45...

  • Page 25: Hi And Lo Messages

    If 'Lo' is displayed again upon retesting, Transferring Test Results Using Cable please contact your healthcare professional immediately. Test results stored in CareSens Dual meter can be transferred from the meter to a computer using SmartLog software and cable. The meter screen displays 'Pc' when Note: it is connected to the computer using the data cable.

  • Page 26: Meter Memory

    Meter Memory The CareSens Dual meter can save up to 1,000 test results with Step 3 Viewing Pre-meal Averages time and date. If the memory is full, the oldest test result will be button Repeatedly press the ◀ deleted and the latest test result will be stored.
  • Page 27 ◀ Press the ◀ button to return to the results seen previously. After checking the stored test results, press the button to turn off the meter. 50 www.i-sens.com www.i-sens.com 51...

  • Page 28: Setting The Alarm Function

    Setting the Alarm Function Four types of alarms can be set in the CareSens Dual Meter: one Setting the Time Alarms (alarm 1–3) post-meal alarm (PP2 alarm) and three time set alarms (alarm1– Step 1 3). The PP2 alarm goes off 2 hours after setting the alarm. The Without inserting a test strip, press the ◀...

  • Page 29: Understanding Error Messages

    Press the button for 3 seconds to finish and turn the meter temperature within the operating range. off. The blood sample has abnormally high viscosity or insufficient volume. > Repeat the test with a new test strip. 54 www.i-sens.com www.i-sens.com 55...

  • Page 30: General Troubleshooting

    • Perform control solution test. Note: Note: If the error messages persist, contact your authorised i-SENS If the problem is not resolved, please contact your sales representative. authorised i-SENS sales representative. 56 www.i-sens.com...

  • Page 31: Performance Characteristics

    Within ± 0.83 mmol/L and Within ± 15% Glucose 598/600 (99.7%) Accuracy: The accuracy of the CareSens Dual Blood Glucose Monitoring System (Model: GM01HAC) was assessed by Precision: The precision studies were performed in a laboratory comparing blood glucose results obtained by patients with using CareSens Dual Blood Glucose Monitoring Systems.
  • Page 32 0.02 mmol/L -0.3 % glucose concentrations below 5.55 mmol/L, and 100% within Gentisic acid 0.04 mmol/L 2.7 % ±15% of the medical laboratory values at glucose concentrations Glucosamine -0.06 mmol/L -2.7 % at or above 5.55 mmol/L. 60 www.i-sens.com www.i-sens.com 61...

  • Page 33: Warranty Information

    Warranty Information β-Ketone Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens Dual Meter shall be free Accuracy: The accuracy of the CareSens Dual Blood Glucose/ of defects in material and workmanship in normal use for a Blood β-Ketone System(Model: GM01HAC) was assessed period of five (5) years.
  • Page 34 MEMO MEMO 64 www.i-sens.com www.i-sens.com 65...
  • Page 35 MEMO 66 www.i-sens.com...

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