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Related Manuals for i-SENS CareSens PRO
Summary of Contents for i-SENS CareSens PRO
- Page 1 Owner’s Booklet i-SENS, Inc. Medical Technology Promedt 43, Banpo-daero 28-gil, Seocho-gu, Consulting GmbH Altenhofstrasse 80, Seoul 06646, Korea www.i-sens.com 66386 St. Ingbert, Germany © 2018 i-SENS, Inc. All Rights Reserved. PGL5E1006 REVA 11/2018...
- Page 2 • The information in this manual is correct at the time of printing. However, i-SENS reserves the right to make any necessary changes at any time without notice as our policy is one of continuous improvement.
- Page 3 CareSens PRO Blood Glucose Monitoring System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -...
- Page 4 PRO meter detects this electrical current and measures the Intended use: amount of glucose in the blood sample. CareSens PRO Blood Glucose Monitoring System is used for • T he CareSens PRO Blood Glucose Meter is designed to the quantitative measurement of the glucose level in capillary...
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Page 5: Specifications
Specifications CareSens PRO Blood Glucose Monitoring System Product specification CareSens PRO System includes the following items: Measurement range 10-600 mg/dL (0.56-33.3 mmol/L) * CareSens PRO Blood Glucose Meter Sample size Minimum 0.4 μL * Owner's Booklet * Batteries Test time... -
Page 6: Inserting Or Replacing The Batteries
Inserting or Replacing the Batteries Caring for Your System The CareSens PRO meter uses two 3.0 V lithium batteries. Before Use a soft cloth or tissue to wipe the meter exterior. If necessary, using the meter, check the battery compartment and insert dip the soft cloth or tissue in a small amount of alcohol. -
Page 7: Confirmation Window
CareSens PRO Blood Glucose Test Strip The CareSens PRO Blood Glucose Monitoring System measures • D o not reuse test strips. blood glucose quickly and accurately. It automatically absorbs • D o not use test strips past the expiration or discard date. the small blood sample applied to the narrow edge of the strip. - Page 8 Month/Day/Hour/Minute Note: Note: • T he cable for data management software can be ordered separately. Please contact your authorised i-SENS sales It is recommended to check if the display screen on the meter representative. matches the illustration above every time the meter turns on. Do not use the meter if the display screen does not exactly •...
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Page 9: Setting Up Your System
Press the ◀ or ▶ button to select a format. appears, press the button to confirm your The AM•PM symbol is not displayed in the selection and to go to the next step. 24-hour format. After selecting the format, press the button to go to the next step. 14 www.i-sens.com www.i-sens.com 15... -
Page 10: 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. 16 www.i-sens.com www.i-sens.com 17... - Page 11 If the expiration date is set to Caution: October of 2020, the meter will Ask your healthcare professional to help you decide what your display 'EP' at the beginning of hypoglycemia level is before setting your level. November, 2020. 18 www.i-sens.com www.i-sens.com 19...
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Page 12: Setting The Strip Expiration Date Indicator
• U se only the CareSens PRO Control Solutions. the month. • C heck the expiration date printed on the bottle. When you first open a CareSens PRO control solution bottle, record the discard date (date opened plus three (3) months) in the space provided on the label. • M ake sure your meter, test strips, and control solution are at... -
Page 13: Control Solution Testing
Press and hold the ▶ button for 3 seconds to activate the Control Solution Test Mode. This will also flag the control solution test result. To undo the control solution flag, press and hold the ▶ button for another 3 seconds. 22 www.i-sens.com www.i-sens.com 23... -
Page 14: Comparing The Control Solution Test Results
Note: The CareSens PRO Control Solution can be purchased If results continue to fall outside the range, the test strip and separately. Please contact your authorised i-SENS sales meter may not be working properly. Do not use your system 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: Blood Glucose Testing
You need a minimum volume Note: The skin depth to get blood samples will vary for of 0.4 microliter for blood glucose test with CareSens PRO test various people at different sample sites. The lancing device's strip. (Actual size of 0.4 μL: ) adjustable tip allows the best depth of skin penetration to get an adequate sample size. - Page 17 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. Test result 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 Fasting flag Caution: The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. 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 0.4 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
Try puncturing again in a smoother area. Note: Please contact your authorised i-SENS sales representative if such messages are displayed even though you do not have hyperglycemia or hypoglycemia. -
Page 21: Target Blood Glucose Ranges
Target Blood Glucose Ranges Meter Memory The CareSens PRO meter can save up to 1,000 test results with Reminders Your target ranges time and date. If the memory is full, the oldest test result will be from your healthcare professional Time of day deleted and the latest test result will be stored. - Page 22 1, 7, 14, 30 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 button ▶ the last test period. 40 www.i-sens.com www.i-sens.com 41...
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Page 23: Setting The Alarm Function
Setting the Alarm Function Viewing Test Results Stored in Memory Four types of alarms can be set in the CareSens PRO Meter: one Step 1 post-meal alarm (PP2 alarm) and three time set alarms (alarm1- 3). The PP2 alarm activates 2 hours after setting the alarm. The Press any button to turn the meter on. -
Page 24: Setting The Time Alarms (Alarm 1-3)
Step 3 Press the◀ button while 'On' blinks to adjust the time of 'alarm1' . A number indicating the hour will blink on the screen. Press the ▶ button to set the hour. 44 www.i-sens.com www.i-sens.com 45... -
Page 25: Understanding Error Messages
Step 6 operating range. Press the button for 3 seconds to finish and turn the meter off. The blood sample has abnormally high viscosity or insufficient volume. > Repeat the test with a new test strip. 46 www.i-sens.com www.i-sens.com 47... -
Page 26: General Troubleshooting
• C heck whether the test strip is of the CareSens PRO test strip. inserted with the contact bars facing > Repeat the test with a CareSens PRO test upwards. Check if the strip has been strip. inserted completely into the test The display is blank strip port. -
Page 27: Performance Characteristics
32.4 mg/dL (1.8 mmol/L) and 606 mg/dL (33.7 mmol/L) System has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the CareSens PRO Blood Glucose Within ± 15 mg/dL (Within ± 0.83 mmol/L) and Within ± 15% Monitoring System (Model: GM01HAA) was assessed by 592/600 (98.7%) - Page 28 100 mg/dL Gentisic acid 0.8 mg/dL 2.7% (5.55 mmol/L), and 99% within ±15% of the medical laboratory Glucosamine -1.1 mg/dL -2.7% values at glucose concentrations at or above 100 mg/dL (5.55 mmol/L). 52 www.i-sens.com www.i-sens.com 53...
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Page 29: Warranty Information
Warranty Information Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens PRO 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.