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Owner's Booklet
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- Page 1 Owner's Booklet Blood Glucose Monitoring System Accurate, complete blood glucose monitoring through advanced biosensor technology i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea www.i-sens.com µL 2017 i-SENS, Inc. All Rights Reserved. PGA1E3350 REV3 02/2017 ©...
- Page 2 Welcome to the CareSens II Blood Glucose Monitoring System Thank you for choosing the CareSens II Blood Glucose Monitoring System. The system provides you with safe, fast, and convenient blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 μL) blood sample.
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Page 3: Table Of Contents
Table of Contents Important Information: Read This First! ---------------------------------------------- CareSens II Blood Glucose Monitoring System ----------------------------------- CareSens II Blood Glucose Meter ----------------------------------------------------- CareSens II Blood Glucose Meter Display ------------------------------------------ Setting Up Your System ------------------------------------------------------------------ Adjusting the Date, Time and Unit ----------------------------------------------- Setting the ‘Test Result Reset’... -
Page 4: Important Information: Read This First
Intended use: CareSens II Blood Glucose Monitoring System amount of glucose in the blood sample. is used for the quantitative measurement of the glucose level The CareSens II blood glucose meter should be used only • in capillary whole blood as an aid in monitoring diabetes with the CareSens strip. -
Page 5: Caresens Ii Blood Glucose Monitoring System
Insert test strip here. Data Port Used to transfer data from the meter to a computer with a cable. Check all the components after opening the CareSens II Blood • Glucose Monitoring System package. The exact contents are listed on the main box. -
Page 6: Caresens Ii Blood Glucose Meter Display
CareSens II Blood Glucose Meter Display Setting up Your System Display Segment Check Press and hold the M button for 3 seconds to enter the set mode. It is recommended to check if the display screen on the meter After all settings are finished, press and hold the M button for 3 matches the illustration (below, above, etc.) every time the meter... - Page 7 [3] Setting the Time Format [7] Setting the Measurement Unit The CareSens II can display results in mg/dL or The meter can be set in the AM/PM (12-hour) or the 24-hour clock format. mmol/L. You may change the unit by pressing Press C button to select a format.
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Page 8: Setting The 'Test Result Reset
Setting the ‘Test Result Reset’ Meter Memory (Deleting all the saved test results) The CareSens II Meter can save up to 250 glucose test results with time and date. If the memory is In this mode all the results stored in the full, the oldest test result will be deleted and the meter can be deleted. -
Page 9: Checking The Meter With The Caresens Check Strip
The CareSens Check Strip is used to determine if the meter is functioning properly. To perform the test, start with the meter turned off. Use the CareSens Check Strip when: the CareSens II meter is used for the first time • • the battery is replaced •... -
Page 10: Coding Meter To Match Test Strips
Coding Meter to Match Test Strips Warning! For accurate results, the code number on the CareSens II Meter The CareSens Test Strips should be used only with fresh • and CareSens Test Strips must match. You must code your meter capillary whole blood samples. -
Page 11: Checking The System
Checking the System Press the M or the C button to select the You may check your meter and test strips using the CareSens Control Solution (control A and/or B). correct code number. Each time you press the M button, the number will increase by The CareSens Control Solution contains a known one, and each time you press the C button, amount of glucose and is used to check that the... -
Page 12: Control Solution Testing
Control Solution Testing You may do a control solution test: Perform the following steps to check the combined performance • When you want to practice the test procedure using the of your Meter and Test Strips or to assess proper testing procedure control solution instead of blood performance. -
Page 13: Comparing The Control Solution Test Results
Please contact your authorised i-SENS sales representative. If results continue to fall outside the range printed on the test strip vial, the Test Strip and Meter may not be working properly. Do not use your system and contact your authorised i-SENS sales representative. -
Page 14: Using The Lancing Device
You will need a lancing device in order to collect a blood Wash hands and fingertip sample sample. site with soap and warm water. Rinse You may use the lancing device included in the CareSens II Blood and dry thoroughly. Glucose Monitoring System or any other medically approved lancing device. -
Page 15: Applying Blood Sample
Applying Blood Sample Select a desired depth of one-to- Obtain a blood sample using the seven (1-7) on the lancing device's lancing device. Place the device against adjustable tip. Choose a depth the pad of the finger as shown in the by rotating the top portion of the diagram. -
Page 16: Discarding Used Lancets
Discarding Used Lancets • Note Unscrew the lancing device tip. 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 apply the blood sample after ( ) symbol appears on the screen. -
Page 17: Alternate Site Testing
Alternate Site Testing What is AST (Alternate Site Testing)? Things to know when using AST Usually, when someone tests their glucose, they take the blood Please read the following before testing at alternate sites sample from the tip of the finger. However, since there are many (forearms, palms, thighs, and calves). -
Page 18: Hi And Lo Messages
• Note If the sample drop of blood runs or spreads due to contact Please contact your authorised i-SENS sales representative, if such with hair or with a line in your palm, do not use that sample. Try messages are displayed even if you do not have hyperglycemia or puncturing again in a smoother area. -
Page 19: Target Blood Glucose Ranges
Target Blood Glucose Ranges Transferring Test Results Test results stored on CareSens II meter can be transferred from the meter to a computer Reminders using SmartLog software and cable. The meter Your target ranges screen displays 'Pc' when it is connected to... -
Page 20: Caring For Your System
Strong electromagnetic radiation may interfere with the proper operation of this device. Keep the device away from sources of strong electromagnetic radiation, especially when measuring your blood glucose. The CareSens II meter should be used only with CareSens • Slide cover down until it clicks. strips. -
Page 21: Specifications
Specifications Understanding Error and Other Messages • Test Range: 20-600 mg/dL (1.1-33.3 mmol/L) Message What It Means What To Do • Sample Size: Minimum 0.5 μL • Test Time: 5 seconds A used test strip Repeat the test with a new test strip. was inserted. -
Page 22: General Troubleshooting
‘ + ’ side facing up. • Replace the batteries. • Check if the confirmation window is The test does not If the error messages persist, contact your authorised i-SENS filled completely. start even after sales representative. applying the blood •... -
Page 23: Performance Characteristics
Performance Characteristics Precision: The performance of CareSens II Blood Glucose Monitoring System The precision studies were performed in a laboratory Strips has been evaluated in laboratory and in clinical tests. using CareSens II BGM Systems. Accuracy: The accuracy of the CareSens II BGM System (Model... -
Page 24: Warranty Information
Warranty Information MEMO Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens II 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. - Page 25 MEMO...