i-SENS CareSens Dual User Manual
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i-SENS CareSens Dual User Manual

Blood b-ketone 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
© 2022 i-SENS, Inc. All Rights Reserved. PGUAA-0000308 REV0 2022-09
Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80
66386 St. Ingbert, Germany
User Manual
Blood Glucose Monitoring System
Blood β-Ketone Monitoring System
Easy Data Transfer by
Bluetooth Connection
GDH-FAD Based Test Strips
E cient Diabetes
Management with
Tagging Symbols
GDH-FAD

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Summary of Contents for i-SENS CareSens Dual

  • Page 1 GDH-FAD Based Test Strips E cient Diabetes Management with Tagging Symbols GDH-FAD i-SENS, Inc. Medical Technology Promedt Consulting GmbH 43, Banpo-daero 28-gil Altenhofstrasse 80 Seocho-gu, Seoul 06646, Korea 66386 St. Ingbert, Germany www.i-sens.com © 2022 i-SENS, Inc. All Rights Reserved. PGUAA-0000308 REV0 2022-09...
  • Page 2 The CareSens Dual Meter is designed to work with the SmartLog™ mobile app. When using the CareSens Dual System, we suggest you pair your CareSens Dual Meter with your smartphone and track your results.
  • Page 3 ® 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...

  • Page 5: Table Of Contents

    - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - CareSens Dual Blood Glucose/Blood β-Ketone Monitoring System...

  • Page 6: Important Information: Read This First

    Alternate site testing from the forearm and palm may also be used to measure glucose levels. The CareSens Dual Blood Glucose and Blood β-Ketone Monitoring System is intended for use outside the body (in vitro diagnostic use) and is intended for use as an aid to monitor the effectiveness of diabetes management.
  • Page 7 • Glucose/β-Ketone in blood samples reacts with the chemical in the test strip to produce a small electrical current. The CareSens Dual meter detects this electrical current and measures the amount of glucose/β-ketone in the blood sample. • The CareSens Dual Blood Glucose/Blood β-Ketone Meter is designed to minimise code related errors in monitoring by using the no-coding function.

  • Page 8: Specifications & Operating Ranges

    Measurement range 10–600 mg/dL (0.6–33.3 mmol/L) Sample size Minimum 0.4 μL Test time 5 seconds Sample type • Fresh capillary whole blood • Fresh venous, neonatal and arterial whole blood (healthcare professionals only) Temperature 5–45 ˚C Hematocrit 15–65 % 8 www.i-sens.com...
  • Page 9 (healthcare professionals only) Temperature 10–40 ˚C Hematocrit 20–60 % Storage and transport conditions Meter 0–50 ˚C (with battery) • Glucose: 1–30 ˚C Temperature Test strip • β-Ketone: 4–30 ˚C Control solution 8–30 ˚C Relative Test Strip 10–90 % humidity www.i-sens.com 9...

  • Page 10: Caresens Dual Blood Glucose/Blood Β-Ketone Monitoring System

    * Batteries * Logbook * Carrying Case • Check all the components after opening the CareSens Dual Blood Glucose/Blood β-Ketone Monitoring System package. The exact contents are listed on the main box. • The cable for data management software can be ordered separately.

  • Page 11: Inserting Or Replacing The Batteries

    Inserting or Replacing the Batteries The CareSens Dual meter uses two 3.0 V lithium batteries. Before using the meter, check the battery compartment and insert batteries if empty. When the symbol appears on the display while the meter is in use, the batteries should be replaced as soon as possible. The test results may not be saved if the batteries run out.

  • Page 12: Caring For Your System

    If you need to throw your meter away, you should follow existing policies and procedures of your own country or region. For information about correct disposal, please contact your local council or authority. If you need assistance, contact your authorised i-SENS sales representative or visit www.i-sens.com. 12 www.i-sens.com...

  • Page 13: Caresens Pro Blood Glucose Test Strip

    CareSens PRO Blood Glucose Test Strip The CareSens Dual Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip. Contact bars Gently push the test strip, with its...
  • Page 14 CareSens PRO test strip package insert. Caution: • Keep the meter and testing supplies away from young children. • Drying agents in the vial cap may be harmful if inhaled or swallowed and may cause skin or eye irritation. 14 www.i-sens.com...

  • Page 15: Ketosens Blood Β-Ketone Test Strip

    KetoSens Blood β-Ketone Test Strip The CareSens Dual Blood β-Ketone Monitoring System measures blood β-ketone quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip. Contact bars Gently push the test strip, with its...
  • Page 16 • For detailed storage and usage information, refer to the KetoSens test strip package insert. Caution: • Keep the meter and testing supplies away from young children. • The test strips and foil packet may be choking hazards. 16 www.i-sens.com...

  • Page 17: Caresens Dual Blood Glucose/Blood Β-Ketone Meter

    CareSens Dual Blood Glucose/Blood β-Ketone Meter Data Port Display Used to transfer data Shows results from the meter to and messages a computer with a cable Button Button ◀ ▶ Turns the meter Turns the meter on, selects on/off, confirms...

  • Page 18: Caresens Dual Blood Glucose/Blood Β-Ketone Meter Display

    CareSens Dual Blood Glucose/Blood β-Ketone Meter Display Memory symbol: appears when test results stored in the memory are displayed PP2 alarm: appears when the post-meal alarm has been set Bluetooth symbol: appears when Bluetooth feature is on Mute symbol: appears only when the...

  • Page 19: Setting Up Your System

    Setting Up Bluetooth Step 2 Bluetooth Pairing If you do not want to connect your meter to your smartphone, press the button when the screen shows on the right. The meter will go to Step 4 Year Setting Mode. www.i-sens.com 19...
  • Page 20 Launch SmartLog mobile app to start pairing the meter with your smartphone. Note: Follow the on-screen instructions on SmartLog mobile app to begin searching your meter. Some content or menus may differ depending on your smartphone's operating system or SmartLog version. 20 www.i-sens.com...
  • Page 21 SmartLog mobile app screen. The meter will display six digit PIN number. Enter the PIN number into the SmartLog mobile app and touch 'OK'. Make sure the PIN you enter on your smartphone matches the PIN on your meter screen. www.i-sens.com 21...
  • Page 22 2 to 5. 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 23: Adjusting The Date And Time

    Step 6 Setting the Date Press the button until the screen ◀ ▶ displays the correct date. Press the button to confirm the date and to go to the next step. www.i-sens.com 23...
  • Page 24 After the hour is set, press the button to go to the next step. Step 9 Setting the Minute Press the button until the correct minute ◀ ▶ appears. After setting the minute, press the button to go to the next step. 24 www.i-sens.com...

  • Page 25: Setting The Sound On/Off

    If the sound is set to OFF, none of the sound functions will work. After setting the sound, press the button to go to the next step. Note: symbol is displayed only when the sound is set to OFF. www.i-sens.com 25...

  • Page 26: Turning On The Strip Expiration Date Indicator

    'EP' when the test strip is inserted. 'EP' shows alternately also when the test result is displayed right after the test. If the expiration date is set to October of 2024, the meter will display 'EP' at the start of November, 2024. 26 www.i-sens.com...

  • Page 27: Setting The Hypoglycemia (Lo) Indicator

    If the test result is lower than 'Lo' warning will blink the pre-set hypoglycemia on the left level, the meter will display the bottom corner. following. Caution: Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your level. www.i-sens.com 27...

  • Page 28: Setting The Hyperglycemia (Hi) Indicator

    'HI' on the bottom. 'KETONE' symbol blinks 3 times when the result is between 241 mg/dL (13.4 mmol/L) and 600 mg/dL (33.3 mmol/L). Caution: Ask your healthcare professional to help you decide what your hyperglycemia level is before setting your level. 28 www.i-sens.com...

  • Page 29: Setting The Strip Expiration Date Indicator

    A number indicating the month will blink at the bottom of the screen. Press the ◀ ▶ button until the correct month appears. Press and hold the button for 3 seconds to confirm the month and turn off the meter. www.i-sens.com 29...

  • Page 30: 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...
  • Page 31 • If the meter or test strips do not function properly, • If your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not working properly, • If you drop or damage the meter. www.i-sens.com 31...

  • Page 32: Control Solution Testing

    After the symbol appears on the display, apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window fills completely. 32 www.i-sens.com...
  • Page 33 2.0-3.8 mmol/L Control H: XX–XX mg/dL (X.X–X.X mmol/L) Caution: The range printed on the test strip vial or box is for the Control Solution only. It has nothing to do with your blood glucose or your blood β-ketone levels. www.i-sens.com 33...

  • Page 34: Comparing The Control Solution Test Results

    • When the control solution is bottle of control contaminated. solution. If results continue to fall outside the range, the test strip and meter may not be working properly. Do not use your system and contact i-SENS sales representative. 34 www.i-sens.com...

  • Page 35: Using The Lancing Device

    • Always use a new sterile lancet. • Keep the lancing device clean. Note: Repeated puncturing at the same sample site may cause pain or skin calluses (thick hard skin). Choose a different site each time you test. www.i-sens.com 35...
  • Page 36 Hold the lancet firmly. Gently twist to pull off protective disk. Save disk to recap lancet after use. Replace lancing device tip. Step 4 Turn the adjustable tip until it is aligned with the load confirmation window and release button as shown. 36 www.i-sens.com...
  • Page 37 Note: The skin depth to get blood samples will vary for various people at different sample sites. The lancing device's adjustable tip allows the best depth of skin penetration to get an adequate sample size. www.i-sens.com 37...

  • Page 38: Blood Glucose/Blood Β-Ketone Testing

    Push the strip in gently until the meter beeps. Be careful not to bend the test strip. The symbol will appear on the screen. When you insert KetoSens test strip, the meter shows 'KETONE' on the screen. 38 www.i-sens.com...
  • Page 39 If the confirmation window is not filled in time because of abnormal viscosity (thickness and stickiness) or insufficient volume, the Er4 message may appear. It is recommended to place the test strip vertically into the blood sample site as shown below. Good Sample Insufficient Sample www.i-sens.com 39...
  • Page 40 The meter may switch off if the blood sample is not applied within 2 minutes of the symbol appearing on the screen. If the meter turns off, remove the strip and reinsert it, and start from Step 2. 40 www.i-sens.com...
  • Page 41 3 seconds. Discard used test strips safely in disposable containers. If the Bluetooth feature is activated, the meter will send the test result to the connected smartphone. Blood glucose test result Blood β-ketone test result www.i-sens.com 41...
  • Page 42 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. No flag Pre-meal flag Post-meal flag Fasting flag 42 www.i-sens.com...
  • Page 43 Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container. Caution: The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. www.i-sens.com 43...

  • Page 44: Alternate Site Testing (For Glucose Only)

    Then press the release button while continuing to apply 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. 44 www.i-sens.com...
  • Page 45 • During two (2) hours after a meal or exercise • When sick or when glucose levels seem quite lower than test value • When hypoglycemia is not well recognised • When insulin has the biggest effect • During two (2) hours after an insulin injection www.i-sens.com 45...
  • Page 46 • If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, do not use that sample. Try puncturing again in a smoother area. 46 www.i-sens.com...

  • Page 47: Hi And Lo Messages

    0.1 mmol/L. If 'Lo' is displayed again upon retesting, please contact your healthcare professional immediately. Note: Please contact your authorised i-SENS sales representative if such messages are displayed even though you do not have hyperglycemia or hypoglycemia. www.i-sens.com 47...

  • Page 48: Target Blood Glucose Ranges

    – 2021. Diabetes Care), January 2021, vol. 44 (Supplement 1): S15-S33. Transferring Test Results Using Cable 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 it is connected to the computer using the data cable.

  • Page 49: Meter Memory

    Meter Memory The CareSens Dual meter can save up to 1,000 test results with time and date. If the memory is full, the oldest test result will be deleted and the latest test result will be stored. The meter only calculates and displays the averages of blood...
  • Page 50 ◀button ◀ view 1, 7, 14, 30, 60 and Fasting 90-day average values average and the number of tests (1, 7, 14, 30, performed during fasting 60, 90 days) with the symbol for the last test period. ▶button 50 www.i-sens.com...
  • Page 51 Step 6 Use the button to scroll back through the averages seen ▶ previously. Press the button to turn off the meter. Note: The control solution test results saved with the symbol are not included in the averages. www.i-sens.com 51...

  • Page 52: Viewing Test Results Stored In Memory

    After checking the stored test results, press button to turn off the meter. Note: The control solution test results saved with the symbol will be displayed with the symbol when you review the stored test results. 52 www.i-sens.com...

  • Page 53: Setting The Alarm Function

    Setting the Alarm Function Four types of alarms can be set in the CareSens Dual meter: one post-meal alert (PP2 alert) and three time set alarms (alarm 1–3). The PP2 alert goes off 2 hours after setting the alert. The alarms ring for 15 seconds and can be silenced by pressing any button or by inserting a test strip.

  • Page 54: Setting The Time Alarms (Alarm 1-3)

    Step 3 Press the button while ‘On’ blinks to ◀ adjust the time of ‘alarm 1’. A number indicating the hour will blink on the screen. Press the button to set the hour. ▶ 54 www.i-sens.com...
  • Page 55 ‘alarm 2’ mode. Repeat steps 2 to 4 to set the remaining time alarms (alarm 2–3). Step 6 Press and hold the button for 3 seconds to finish and turn the meter off. www.i-sens.com 55...

  • Page 56: Understanding Error Messages

    β-ketone test (10–40 ˚C) and repeat the test after the meter and test strips have reached a temperature within the operating range. The blood sample Repeat the test with a new has abnormally test strip. high viscosity or insufficient volume. 56 www.i-sens.com...
  • Page 57 An electronic error Repeat the test with a new occurred during test strip. If the error the test. message persists, contact your authorised i-SENS sales representative. Note: If the error messages persist, contact your authorised i-SENS sales representative. www.i-sens.com 57...

  • Page 58: General Troubleshooting

    The test result does not match the • Check the expiration or discard date way you feel. of the test strip. • Perform control solution test. Note: If the problem is not resolved, please contact your authorised i-SENS sales representative. 58 www.i-sens.com...

  • Page 59: Performance Characteristics

    β-Ketone Monitoring System has been evaluated in laboratory and in clinical tests. Glucose Accuracy: The accuracy of the CareSens Dual Blood Glucose Monitoring System (Model: GM01HAC) was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument.
  • Page 60 This study shows that there could be variation of up to 4.2 %. β-Ketone Accuracy: The accuracy of the CareSens Dual Blood β-Ketone System (Model: GM01HAC) was assessed by comparing blood β-ketone results obtained by patients with those obtained using a Randox Monaco, a laboratory instrument.

  • Page 61: Influence Quantities

    Correlation coefficient (r) 0.996 Number of subjects Range tested 0.015–7.2 mmol/L Precision: Precision studies were performed in a laboratory using the CareSens Dual Blood β-Ketone Monitoring Systems. Within Run Precision 0.5 mmol/L SD = 0.04 mmol/L 1.4 mmol/L SD = 0.05 mmol/L 3.2 mmol/L...
  • Page 62 Gentisic acid 50 mg/dL (3.24 mmol/L) Glucosamine 9 mg/dL (0.50 mmol/L) 2-deoxyglucose 8.2 mg/dL (0.50 mmol/L) Glutathione (Red) 17 mg/dL (0.55 mmol/L) Hemoglobin 500 mg/dL (0.08 mmol/L) Heparin 8000 U/dL Ibuprofen 40 mg/dL (1.94 mmol/L) Icodextrin 1094 mg/dL 62 www.i-sens.com...
  • Page 63 50–100 mg/dL (2.8–5.6 mmol/L) may cause overestimation of blood glucose results. β-Ketone Packed cell volume (Hematocrit) Packed cell volume evaluation was conducted in various hematocrit levels. The range of hematocrit levels within the acceptance criteria is 20–60 %. www.i-sens.com 63...
  • Page 64 60 mg/dL (3.33 mmol/L) Gentisic acid 50 mg/dL (3.24 mmol/L) Glucose 360 mg/dL (19.98 mmol/L) Glutathione (Red) 20 mg/dL (0.65 mmol/L) Hemoglobin 500 mg/dL (0.31 mmol/L) Heparin 8000 U/dL Ibuprofen 40 mg/dL (1.94 mmol/L) L-Dopa 5 mg/dL (0.25 mmol/L) (L-3,4-dihydroxyphenylalanine) 64 www.i-sens.com...

  • Page 65: User Performance Evaluation

    99.1 % within ±15 mg/dL (±0.83 mmol/L) of the medical laboratory values at glucose concentrations below 100 mg/dL (5.55 mmol/L) and 100 % within ±15 % of the medical laboratory values at glucose concentrations at or above 100 mg/dL (5.55 mmol/L). www.i-sens.com 65...

  • Page 66: Warranty Information

    Warranty Information Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens Dual 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.

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