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•  Glucose in blood samples reacts with the chemical in the

test strip to produce a small electrical current. The CareSens

PRO meter detects this electrical current and measures the

amount of glucose in the blood sample.

•   The CareSens PRO Blood Glucose  Meter is designed to

minimise code related errors in monitoring by using the

no-coding function.

•   The CareSens PRO Blood Glucose  Meter should be used

only with the CareSens PRO Test Strips.

 An abnormally high or low red blood cell count (hematocrit

level over 65% or below 15%) may produce inaccurate

results.

 If your blood glucose test result is below 60 mg/dL

(3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult a

healthcare professional immediately.

 Inaccurate blood glucose results may occur in severely

hypotensive individuals or patients in shock. Inaccurate low

blood glucose results may occur for individuals experiencing

a hyperglycemic- hyperosmolar state, with or without

ketosis. Critically ill patients should not be tested with blood

glucose meters.

 

Do not use during or within 24 hours of receiving xylose

absorption testing as it may cause inaccurate results.

If you need assistance, please contact your authorised i-SENS  

sales representative or visit www.i-sens.com for more information.

Important Information: Read This First!

For optimum safety and benefits, please read the entire manual 

contents before using the system.

Intended use:

CareSens PRO Blood Glucose Monitoring System is used for 

the quantitative measurement of the glucose level in capillary 

whole blood as an aid in monitoring diabetes management 

effectively at home or in clinical settings. Fresh venous whole 

blood drawn by healthcare professionals can be used also. 

CareSens PRO Blood Glucose Monitoring System should be used 

only for self-testing outside the body (

in vitro

 diagnostic use 

only). CareSens PRO Blood Glucose Monitoring System should 

not be used for the diagnosis of diabetes. Testing sites include 

the traditional fingertip testing along with alternate site testing 

on forearm and palm.

For 

in vitro

 diagnostic use

This product fulfills the requirements for Directive 98/79/EC 

on 

in vitro

 diagnostic medical devices.

Cautions for safety and optimum product use
Do not discard this product with other household-type 

waste 
Use by 

Authorised representative

Do not reuse 

Batch code

Consult instructions for use 

Manufacturer

Temperature limitation 

Serial number

Meaning of Symbols Used: 

Summary of Contents for CareSens PRO

Page 1: ...l Rights Reserved PGL5E1006 REVA 11 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 Germ...

Page 2: ...in just 5 seconds with a small 0 4 L blood sample WelcometotheCareSens PROBloodGlucose MonitoringSystem No part of this document may be reproduced in any form or by any means without the prior writte...

Page 3: ...cator 19 Setting the Strip Expiration Date Indicator 20 Checking the System 21 Control Solution Testing 22 Comparing the Control Solution Test Results 25 Testing Using the Lancing Device 26 Blood Gluc...

Page 4: ...ause inaccurate results If you need assistance please contact your authorised i SENS sales representative or visit www i sens com for more information Important Information ReadThis First For optimum...

Page 5: ...horised i SENS sales representative Specifications CareSens PRO Blood Glucose Monitoring System Operating ranges Storage Conditions Product specification Measurement range 10 600 mg dL 0 56 33 3 mmol...

Page 6: ...meter check the battery compartment and insert batteries if empty When the symbol appears on the display while the meter is in use the batteries should be replaced as soon as possible The test results...

Page 7: ...e CareSens PRO 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: ...e after eating Fasting test flag used for tests done after fasting for at least 8 hours Month Day Hour Minute 10 12 7 8 9 11 13 14 2 3 5 4 6 10 9 8 1 14 11 12 13 Note It is recommended to check if the...

Page 9: ...ss the or button to adjust until the correct year appears When the present year appears press the S button to confirm your selection and to go to the next step Step 3 Setting the Month A number indica...

Page 10: ...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 Setting the Sound On OFF Note The symbol is displayed only when the sound is set to O...

Page 11: ...level is before setting your level Note If the test result is lower than the pre set hypoglycemia level the meter will display the following HYPowarning willblinkatthe bottom Step 9 This setting allow...

Page 12: ...L and or H The CareSens PRO Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly The CareSens PRO test strip vials have Car...

Page 13: ...up Step 2 Activating Control Solution Test Mode Press and hold the button for 3 seconds to activate the Control SolutionTest Mode This will also flag the control solution test result To undo the cont...

Page 14: ...trol 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 the test strip and meter may not b...

Page 15: ...device The lancing device is for use by a single user only and should not be shared with anyone Use a soft cloth or tissue to wipe the lancing device If necessary a small amount of alcohol on a soft c...

Page 16: ...The symbol will appear on the screen Preparing the Meter and Test Strip Blood GlucoseTesting Step 5 The lancing device has six puncture depth settings 0 for a shallow puncture 5 for a deeper puncture...

Page 17: ...the blood is going in Test result will appear after the meter counts down from 5 to 1 The result will be automatically stored in the meter s memory If the test strip is removed after the test result...

Page 18: ...st press or button to select a pre meal flag a post meal flag or a fasting flag When you remove the test strip while the desired flag is blinking the test result is stored with the flag If you do not...

Page 19: ...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 durin...

Page 20: ...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 y...

Page 21: ...d for the last test period button button Average 1 7 14 30 60 90days Target Blood Glucose Ranges Reminders Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Be...

Page 22: ...ormed pre meals with the symbol for the last test period Step 4 Viewing Post meal Averages Press the button to view 1 7 14 30 and 90 day average values and the number of tests performed post meals wit...

Page 23: ...ting the Post meal Alarm PP2 alarm Step 1 Press any 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 numb...

Page 24: ...on again to cancel alarm1 OFF will blink on the screen 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 se...

Page 25: ...Repeat the test with a new test strip The temperature during the test was above or below the operating range Move to an area where the temperature is within the operating range 5 45 C and repeat the...

Page 26: ...ter inserting a test strip The test does not start even after applying the blood sample on the strip The test result does not match the way you feel General Troubleshooting Note If the problem is not...

Page 27: ...8 3 3 1 7 mg dL 0 2 0 1 mmol L 96 to 144 5 3 to 8 0 3 6 1 7 280 to 420 15 5 to 23 3 8 9 6 2 Range mg dL mmol L Average of difference Hct 15 65 Performance Characteristics The performance of CareSens...

Page 28: ...in 15 of the medical laboratory values at glucose concentrations at or above 100 mg dL 5 55 mmol L Compounds of xylose 9 69 mg dL 0 54 mmol L at glucose concentrations of 50 100 mg dL 2 8 5 6 mmol L m...

Page 29: ...handling tampering use or service of the meter Any claim must be made within the warranty period i SENS will at its discretion repair or replace a defective meter or meter part that is covered by this...

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