i-SENS CareSens N Pop, Owner'S Booklet

Page 1: ...ll Rights Reserved PGA1E3247 REV0 05 2018 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 Owner s Booklet ...

Page 2: ... just 5 seconds with a small 0 5 μL blood sample Welcome to the CareSens N POP Blood Glucose Monitoring System No part of this document may be reproduced in any form or by any means without the prior written consent of i SENS 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 ...

Page 3: ...tting the Strip Expiration Date Indicator 20 Checking the System 21 Control Solution Testing 22 Comparing the Control Solution Test Results 24 Testing Using the Lancing Device 25 Preparing the Lancing Device 26 Preparing the Meter and Test Strip 28 Flagging Post meal Test Results 28 Applying Blood Sample 29 Discarding Used Lancets 31 Alternate Site Testing 32 HI and Lo Messages 35 Target Blood Glu...

Page 4: ...toring by using the no coding function The CareSens N POP Blood Glucose Meter should be used only with the CareSens N test strips An abnormally high or low red blood cell count hematocrit level over 65 or below 15 may produce inaccurate results If your test result is below 3 3 mmol L or above 13 3 mmol L consult a healthcare professional immediately Inaccurate results may occur in severely hypoten...

Page 5: ...es Temperature 5 50 C 41 122 F Relative humidity 10 90 Hematocrit 15 65 Check all the components after opening the CareSens N POP blood glucose monitoring system package The exact contents are listed on the main box The cable for data management software can be ordered separately Please contact your authorised i SENS sales representative Components CareSens N POP BGM System includes the following ...

Page 6: ... soft cloth or tissue to wipe the meter exterior If necessary dip the soft cloth or tissue in a small amount of alcohol Do not use organic solvents such as benzene acetone or household and industrial cleaners that may cause irreparable damage to the meter Caution Do not expose the meter to direct sunlight heat or excessive humidity for an extended period of time Do not let dirt dust blood or water...

Page 7: ...st strip for testing and use the strip immediately Handle test strips only with clean and dry hands Do not bend cut or alter test strips in any way For detailed storage and usage information refer to the CareSens N 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...

Page 8: ...icates meter is ready for the application of a drop of blood or control solution Decimal point appears when the blood glucose measuring unit is set to mmol L 10 12 13 1 2 3 4 5 6 7 8 9 11 Note It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on Do not use the meter if the display screen does not exactly match the illustration a...

Page 9: ...ot displayed in the 24 hour format After selecting the format press the button to go to the next step Setting UpYour System Press and hold the button for 3 seconds to enter SET mode After all settings are finished press and hold the button for 3 seconds to turn off the meter Press the button to change values Press and hold the button to scroll faster Adjusting the Date and Time Step 1 Entering the...

Page 10: ...played When you press and hold the button to set the post meal PP2 alarm When it is time for a pre set blood glucose test 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 Setting the Sound On OFF Note The symbol is displayed only when the sound is set to OFF Step 7 Setting the Minute Press the button until the correct ...

Page 11: ...hen the screen will return to step 2 See page 14 To confirm all settings press and hold the button for 3 seconds and the screen will switch off Turning on the Hypoglycemia HYPo Indicator Caution Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your level Note If the test result is lower than the pre set hypoglycemia level the meter will display the...

Page 12: ...e the tip clean Close the control solution bottle tightly and store at a temperature between 8 30 C 46 86 F You may do a control solution test When you want to practice the test procedure using the control solution instead of blood When using the meter for the first time Setting the Strip Expiration Date Indicator Step 1 Entering the Expiration Date Setting Press and hold the and buttons at the sa...

Page 13: ...l L Control B 10 2 15 3 mmol L Control Solution Testing Step 1 Insert a test strip into the meter s test strip port with the contact bars facing upwards Gently push the test strip into the port until the meter beeps Be careful not to bend the strip while pushing it in The symbol will show up Note The meter may switch off if the control solution sample is not applied within 2 minutes of the symbol ...

Page 14: ... Lancet Comparing the Control Solution Test Results The test result of each control solution should be within the range printed on the label of the test strip vial Repeat the control solution test if the test result falls outside of the range Out of range results may occur in following situations If results continue to fall outside the range printed on the test strip vial the test strip and meter ...

Page 15: ...y 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 Note 0 a shallow puncture for softer skin 5 a deeper puncture for thick or calloused skin Preparing the Lancing Device Step 1 Wash hands and sample site with soap and warm water Rinse and dry thoroughly Step 2 Unscrew and remove the lancing dev...

Page 16: ... 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 Step 7 Insert a test strip with the contact bars facing upwards into the meter s test strip port Push the strip in gently until the meter beeps Be careful not to bend the test strip The symbol w...

Page 17: ...the test result is displayed the meter will automatically switch off after 3 seconds Discard used test strips safely in disposable containers Note 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 7 Caution Do not allow any foreign substances such as dirt blo...

Page 18: ...However since there are many nerve endings in the fingertip it can be quite painful When doing a glucose test using different parts of the body such as the forearms and palms can reduce the pain during testing This method of testing with different parts of the body is called Alternate Site Testing While AST may reduce the pain during testing it may not be simple for everyone and the following prec...

Page 19: ...even though you do not have hyperglycemia or hypoglycemia AST Precautions Before using AST please consult your healthcare professional Do not ignore the symptoms of hyperglycemia or hypoglycemia When the results of the test do not reflect your opinion retest using the fingertip test If the fingertip result still does not reflect the way you feel please consult your healthcare professional Do not r...

Page 20: ...Reminders Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a m and 4 a m Your target ranges from your healthcare professional ExpectedValues The range of a normal fasting blood glucose level for non diabetic adults is between 3 9 5 5 mmol L Two 2 hours after a meal the range of a normal blood glucose level for non diabetic adults is less than 7 8...

Page 21: ...7 14 30 90days Meter Memory Step 1 Press the or button to turn the meter on The current date and time will be displayed at the bottom of the screen followed by the 1 day average value and the number of the test results saved within the current day Viewing Averages Step 2 Viewing Averages Press the button to view 7 14 30 and 90 day average values and the number of tests performed for the last test ...

Page 22: ...displayed The PP2 alarm activates 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by pressing the or button or by inserting a test strip alarm disappears ViewingTest Results Stored in Memory button button Step 1 Press the button to turn the meter on The current date and time will be displayed on the bottom of the screen followed by the 1 day average value and the...

Page 23: ...est strip If the error message persists contact your authorised i SENS sales representative Repeat the test with a CareSens N test strip The blood or control solution sample was applied before the symbol appeared Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control solution sample Message What It Means The temperature during the test was abov...

Page 24: ...SENS sales representative Performance Characteristics The performance of CareSens N POP Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests Accuracy The accuracy of the CareSens N POP Blood Glucose Monitoring System Model GM505WAC GM505WBC was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analy...

Page 25: ...t of glucose concentration Range mmol L Average of difference Hct 15 65 1 7 to 2 8 0 2 0 1 mmol L 5 3 to 8 0 1 5 7 1 15 5 to 23 3 5 4 1 1 Difference Averages No Interferent 1 Acetaminophen 0 1 mmol L 3 3 2 Ascorbic acid 0 4 mmol L 0 9 3 Bilirubin unconjugated 0 01 mmol L 1 4 4 Ceftriaxone 0 1 mmol L 2 4 5 Cholesterol 0 1 mmol L 1 8 6 Creatinine 0 01 mmol L 0 7 7 Dopamine 0 1 mmol L 0 4 8 EDTA 0 1 ...

Page 26: ...ow 5 55 mmol L and 98 3 within 15 of the medical laboratory values at glucose concentrations at or above 5 55 mmol L Warranty Information Manufacturer s Warranty i SENS Inc warrants that the CareSens N POP 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 handli...

Page 27: ...50 www i sens com MEMO ...