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Table of Contents Information Important Information: Read This First! Specifications CareSens N Blood Glucose Monitoring System Inserting or Replacing the Batteries Caring for Your System CareSens N Blood Glucose Test Strip CareSens N Blood Glucose Meter CareSens N Blood Glucose Meter Display Preparation Setting Up Your System Adjusting the Date and Time...
Cautions for safety and optimum product use oxygen therapy. Use by (unopened or opened test strip vial) If you need assistance, please contact your authorised i-SENS Do not discard this product with other household-type waste sales representative or visit www.i-sens.com for more information.
5-50˚C (41-122˚F) Relative humidity 10-90% • C heck all the components after opening the CareSens N Blood Glucose Monitoring System package. The exact contents are Hematocrit 15-65% listed on the main box. • T he cable for data management software can be ordered separately. Please contact your authorised i-SENS sales representative. 6 www.i-sens.com www.i-sens.com 7...
Place the cover on the battery compartment. Push down until you hear the tab click into place. Note: Removing the meter batteries will not affect your stored results. However, you may need to reset your meter settings. See pages 14-17. 8 www.i-sens.com www.i-sens.com 9...
Apply blood sample here for testing • D o not bend, cut, or alter test strips in any way. • F or detailed storage and usage information, refer to the CareSens N Test Strip package insert. Caution: • K eep the meter and testing supplies away from young children. • D rying agents in the vial cap may be harmful if inhaled or swallowed and may cause skin or eye irritation. 10 www.i-sens.com www.i-sens.com 11...
It is recommended to check if the display screen on the • T he cable for data management software can be ordered meter matches the illustration above every time the meter separately. Please contact your authorised i-SENS sales turns on. Do not use the meter if the display screen does not representative.
The AM/PM is not displayed button to confirm your selection and go in the 24-hour format. to the next step. After selecting the format, press the S button to go to the next step. 14 www.i-sens.com www.i-sens.com 15...
OFF. • A t any stage, press the S button for 3 seconds to exit SET mode and turn off the meter. Press and hold to quickly scroll through the numbers. 16 www.i-sens.com www.i-sens.com 17...
2 minutes of the symbol appearing on • When using the meter for the first time, the screen. If the meter turns off, remove the strip, reinsert, • Whenever you open a new vial of test strips, and start from step 1. • If the meter or test strips do not function properly, • I f your symptoms are inconsistent with the blood glucose test 18 www.i-sens.com www.i-sens.com 19...
CareSens N Test Strip and Meter may not be working properly. Do not use your system and contact your Note: The CareSens Control Solution can be purchased authorised i-SENS sales representative. separately. Please contact your authorised i-SENS sales representative. 20 www.i-sens.com www.i-sens.com 21...
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. 22 www.i-sens.com www.i-sens.com 23...
( ). get an adequate sample size. If you do not want to save the result as a post- meal test, move on to step 9 after step 7. 24 www.i-sens.com www.i-sens.com 25...
3 seconds. shown in the diagram below. Discard used test strips safely in appropriate containers. Good Sample Insufficient Sample 26 www.i-sens.com www.i-sens.com 27...
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. 28 www.i-sens.com www.i-sens.com 29...
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Note: 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 • During two (2) hours after an insulin injection sample. Try puncturing again in a smoother area. 30 www.i-sens.com www.i-sens.com 31...
American Diabetes Association. “Standards of Medical Care in Diabetes – 2016. ” Diabetes Care. January 2016; 39(1):S15, S100. Note: Please contact your authorised i-SENS sales representative if such messages are displayed even though you do not have hyperglycemia or hypoglycemia.
) results computer using the data cable. from the last 1, 7, 14, 30 and 90 days. For more information, contact your authorised i-SENS sales representative or visit Viewing Averages Stored in the Memory www.i-sens.com. Step 1 Press the or S button to turn the meter on.
Note: The control solution test results saved with 'check' Note: The control solution test results saved with 'check' are will be displayed with 'check' when you review the stored not included in the averages. test results. 36 www.i-sens.com www.i-sens.com 37...
Press to set the time. the bell ( ) symbol, and ‘OFF’ will Press to end. appear on the screen. Then the screen will change automatically to the memory check mode without the bell ( ) symbol displayed. symbol disappears 38 www.i-sens.com www.i-sens.com 39...
(5-50˚C/41- 122˚F) and repeat the test after the meter and test strips have reached a temperature within the operating range. 40 www.i-sens.com www.i-sens.com 41...
Note: If the problem is not resolved, please contact your sales representative. authorised i-SENS sales representative. Note: If the error messages persist, contact your authorised i-SENS sales representative. 42 www.i-sens.com www.i-sens.com 43...
System has been evaluated in laboratory and in clinical tests. using CareSens N BGM Systems. Accuracy: The accuracy of the CareSens N BGM System (Model Within Run Precision GM505PAD, GM505PBD, GM505PCD) was assessed by comparing Blood avg. 2.1 mmol/L SD = 0.1 mmol/L blood glucose results obtained by patients with those Blood avg.
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100% within ± 0.83 mmol/L of the medical laboratory values Hydrocortisone 0.02 mmol/L 1.9% at glucose concentrations below 5.55 mmol/L, and 99.6% within ±15% of the medical laboratory values at glucose Ibuprofen -0.1 mmol/L 2.8% concentrations at or above 5.55 mmol/L. Icodextrin -0.2 mmol/L -0.5% 46 www.i-sens.com www.i-sens.com 47...
Warranty Information Manufacturer’s Warranty MEMO i-SENS, Inc. warrants that the CareSens N 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.