i-SENS CareSens N Owner's Booklet
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- User manual (48 pages) ,
- Owner's booklet (29 pages) ,
- Manual (23 pages)
Table of Contents
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Table of Contents
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Summary of Contents for i-SENS CareSens N
- Page 1 Owner’s Booklet NFC antenna in the back of the meter i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80, 66386 St. Ingbert, Germany © 2018 i-SENS, Inc. All Rights Reserved PGA1E3422 REV1 12/2018...
- Page 2 Welcome to the CareSens N NFC How to Tag Your Meter to Your Smartphone Blood Glucose Monitoring System Thank you for choosing the CareSens N NFC Blood Glucose ❶ Antenna located in the ❷ Antenna located in the mid- Monitoring System. The system provides you with safe, fast, and...
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Page 3: Table Of Contents
Inserting or Replacing the Battery ------------------------------------------------------- Caring for Your System ------------------------------------------------------------------------ CareSens N Blood Glucose Test Strip --------------------------------------------------- CareSens N NFC Blood Glucose Meter -------------------------------------------------- CareSens N NFC Blood Glucose Meter Display --------------------------------------- Preparation Setting Up Your System -------------------------------------------------------------------- Adjusting the Date and Time -----------------------------------------------------------... -
Page 4: Important Information: Read This First
CareSens N NFC meter detects this electrical current and Intended use: measures the amount of glucose in the blood sample. CareSens N NFC Blood Glucose Monitoring System is used for the • The CareSens N NFC Blood Glucose Meter is designed to... -
Page 5: Specifications
93 X 47 X 15 (mm) Weight 51.5 g (with battery) Operating ranges Temperature 5-50˚C (41-122˚F) • Check all the components after opening the CareSens N Relative humidity 10-90% NFC Blood Glucose Monitoring System package. The exact Hematocrit 15-65% contents are listed on the main box. -
Page 6: Inserting Or Replacing The Battery
Inserting or Replacing the Battery Caring for Your System The CareSens N NFC Meter comes with one 3.0 V lithium battery. Use a soft cloth or tissue to wipe the meter exterior. If necessary, Before using the meter, check the battery compartment and dip the soft cloth or tissue in a small amount of alcohol. -
Page 7: Caresens N Blood Glucose Test Strip
The CareSens N NFC Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs • The CareSens N Test Strips should be used only with fresh the small blood sample applied to the narrow edge of the strip. capillary whole blood samples. -
Page 8: Caresens N Nfc Blood Glucose Meter
CareSens N NFC Blood Glucose Meter CareSens N NFC Blood Glucose Meter Display PP2 alarm NFC icon appears when the appears when NFC Data Port post-meal alarm has Time Synchronization been set Used to transfer data function is performed from the meter to a... -
Page 9: Setting Up Your System
24-hour clock format. Press the or button to select a format. The AM•PM symbol is not displayed in the 24-hour format. After selecting the format, press the S button to go to the next step. 14 www.i-sens.com www.i-sens.com 15... -
Page 10: Setting The Sound On/Off
After setting the sound, press the S button to progress to the next step. Note: • The symbol is displayed only when the sound is set to OFF. • At any stage, press the S button for 3 seconds to exit SET mode and turn off the meter. 16 www.i-sens.com www.i-sens.com 17... -
Page 11: Turning On The Strip Expiration Date Indicator
If the expiration date is set to October of 2019, the meter Caution: Ask your healthcare professional to help you will display "EP" at the start of November, 2019. decide what your hypoglycemia level is before setting your hypoglycemic level. 18 www.i-sens.com www.i-sens.com 19... -
Page 12: Setting The Strip Expiration Date Indicator
A number indicating the month will blink at the bottom of the screen. Press the or button until the correct month appears. Press and hold the S button for 3 seconds to confirm the month and turn off the meter. 20 www.i-sens.com www.i-sens.com 21... -
Page 13: Control Solution Testing
Step 2 You can flag the control solution test result by pressing the button for 3 seconds. To undo the control solution flag, press the button for 3 seconds again. 22 www.i-sens.com www.i-sens.com 23... -
Page 14: Comparing The Control Solution Test Results
Please contact your authorised i-SENS sales contaminated. representative. If results continue to fall outside the range, the CareSens N Test Strip and CareSens N NFC Meter may not be working properly. Do not use your system and contact your authorised i-SENS sales representative. -
Page 15: Using The Lancing Device
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. 26 www.i-sens.com www.i-sens.com 27... -
Page 16: Preparing The Meter And Test Strip
The skin depth to get blood samples will vary for (Actual size of 0.5 µL : ). 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. 28 www.i-sens.com www.i-sens.com 29... - Page 17 Test result upwards. The blood sample may run down the surface of the test strip and flow into the test strip port. • Do not store your meter in unsanitary or contaminated sites. 30 www.i-sens.com www.i-sens.com 31...
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Page 18: Discarding Used Lancets
No flag Pre-meal flag Post-meal flag Caution: The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. Fasting flag Control solution flag 32 www.i-sens.com www.i-sens.com 33... -
Page 19: Alternate Site Testing
Then press the release button while continuing to apply pressure. Keep holding the lancing device against your skin until sufficient (at least 0.5 μL, actual size: ) blood is drawn. Carefully lift the lancing device away from your skin. 34 www.i-sens.com www.i-sens.com 35... -
Page 20: Hi And Lo Messages
Note: Please contact your authorised i-SENS sales • If the sample drop of blood runs or spreads due to contact representative, if such messages are displayed even though with hair or with a line in your palm, do not use that sample. -
Page 21: Target Blood Glucose Ranges
The communication distance may differ on the Transferring Test Results type of smartphones used. Test results stored on the CareSens N NFC meter can be transferred from the meter to a computer using SmartLog software and cable. The meter screen displays "Pc"... -
Page 22: Meter Memory
Meter Memory Methods to Use the NFC Function The CareSens N NFC Meter can save up to 500 glucose test results with time and date. If the memory is full, the oldest test Step 1 result will be deleted and the latest test result will be stored. - Page 23 (1, 7, 14, 30, performed post-meals 90 days) with the symbol for Note: The control solution test results saved with the the last test period. symbol are not included in the averages. button 42 www.i-sens.com www.i-sens.com 43...
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Page 24: Viewing Test Results Stored In The Memory
Setting the Alarm Function Viewing Test Results Stored in the Memory Four types of alarms can be set in the CareSens N NFC Meter: one post-meal alarm (PP2 alarm) and three time set alarms Step 1 (alarm1-3). The PP2 alarm goes off 2 hours after setting the Press any button to turn the meter alarm. -
Page 25: Setting The Time Alarms (Alarm 1-3)
Press the S button for 3 seconds to finish and turn the meter off. Press the button to adjust the time of 'alarm 1' . A number representing the time will blink on the screen. Press the button to set the time. Press the button to end. 46 www.i-sens.com www.i-sens.com 47... -
Page 26: Understanding Error Messages
Repeat test after This error message The blood or control Repeat the test with a may appear when inserting a CareSens N solution sample was new test strip and the wrong blood test strip. applied before the wait until the... -
Page 27: General Troubleshooting
• Check the expiration date of the test you feel. strip. • Perform control solution test. Note: If the problem is not resolved, please contact your authorised i-SENS sales representative. Note: If the error messages persist, contact your authorised i-SENS sales representative. 50 www.i-sens.com www.i-sens.com 51... -
Page 28: Performance Characteristics
System has been evaluated in laboratory and in clinical tests. mg/dL (1.6 mmol/L) and 479 mg/dL(26.6 mmol/L) Accuracy: The accuracy of the CareSens N NFC BGM System Within ± 15 mg/dL (Within ± 0.83 mmol/L) and Within ± 15% (Model GM505PAG, GM505PBG, GM505PCG) was assessed by... - Page 29 0.4 mg/dL (0.02 mmol/L) 1.9% 100 mg/dL(5.55 mmol/L), and 100% within ±15% of the Ibuprofen -1.5 mg/dL (-0.1 mmol/L) 2.8% medical laboratory values at glucose concentrations at or above 100 mg/dL(5.55 mmol/L). Icodextrin -2.7 mg/dL (-0.2 mmol/L) -0.5% 54 www.i-sens.com www.i-sens.com 55...
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Page 30: Warranty Information
Warranty Information Manufacturer’s Warranty MEMO i-SENS, Inc. warrants that the CareSens N NFC 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 31 MEMO 58 www.i-sens.com...