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  5. Owner's Booklet

I-SENS CARESENS DUAL Owner's Booklet

Manual is about: BLOOD GLUCOSE MONITORING SYSTEM

Summary of CARESENS DUAL

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    ? 2016 i-sens, inc. All rights reserved. Pgl6e2202 rev1 07/2016 i-sens, inc. 43, banpo-daero 28-gil, seocho-gu, seoul 06646, korea www.I-sens.Com medical technology promedt consulting gmbh, altenhofstrasse 80, d-66386 st. Ingbert, germany owner’s booklet blood glucose monitoring system blood β-keton...

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    Thank you for choosing the caresen dual blood glucose/blood β-ketone monitoring system. The system provides you with rapid and convenient blood glucose/blood β-ketone in vitro (i.E., outside the body) diagnostic monitoring. Test results can be sent to a smartphone through bluetooth® smart wireless c...

  • Page 3: Warning:

    The bluetooth® word mark and logos are registered trademarks owned by bluetooth sig, inc. And any use of such marks by i-sens, inc. Is under license. All other trademarks and trade names are those of their respective owners. Warning: turn off the bluetooth feature in areas where the use of wireless ...

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    Table of contents information important information: read this first! --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------...

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    6 www.I-sens.Com www.I-sens.Com 7 important information: read this first! For optimum safety and benefits, please read the entire manual contents before using the system. Intended use: caresens dual blood glucose/blood β-ketone monitoring system is used for the quantitative measurement of the glucos...

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    8 www.I-sens.Com www.I-sens.Com 9 specifications & operating ranges for blood glucose testing for blood β-ketone testing calibration plasma-equivalent assay method electrochemical battery life 1,000 tests power two 3.0 v lithium batteries (disposable, type cr2032) memory 1,000 test results size 106 ...

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    10 www.I-sens.Com www.I-sens.Com 11 the caresens dual meter uses two 3.0 v lithium batteries. Before using the 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. T...

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    12 www.I-sens.Com www.I-sens.Com 13 warning! • the caresens pro test strips should be used with fresh capillary whole blood samples, or with fresh venous whole blood if drawn by healthcare professionals. • fresh venous whole blood specimens containing the anticoagulants edta and heparin are acceptab...

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    14 www.I-sens.Com www.I-sens.Com 15 ketosens blood β-ketone test strip the caresens dual blood β-ketone monitoring system measures blood β-ketone quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip. Insert contact bars gently push the test ...

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    16 www.I-sens.Com www.I-sens.Com 17 note: • the cable for data management software can be ordered separately. Please contact your authorised i-sens sales representative. • the unit of measurement is fixed and it cannot be changed by the user. Caresens dual meter display shows results, messages s but...

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    18 www.I-sens.Com www.I-sens.Com 19 setting up your system press and hold the s for 3 seconds to enter the set mode. After all settings are finished, press and hold the s button for 3 seconds to turn off the meter. Press ◀,▶ to change values. Press and hold ◀,▶ to scroll faster. Step 1 entering set ...

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    20 www.I-sens.Com www.I-sens.Com 21 serial number 3 look for 'caresens' and the last 4 characters of the meter serial number on the smartlog mobile app screen to correctly identify your meter. Touch your meter's id (caresens xxxx) on the smartlog mobile app screen. 4 the meter will display six digit...

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    22 www.I-sens.Com www.I-sens.Com 23 adjusting the date and time step 4 setting the year press 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 5 setting the month a number indicati...

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    24 www.I-sens.Com www.I-sens.Com 25 step 10 on pressing the ◀ or ▶ button, the screen will display on or off. Press the s button to confirm the selection. The meter will beep in the following instances if set to on. • when you push a button to turn on the meter • when the test strip is inserted in t...

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    26 www.I-sens.Com www.I-sens.Com 27 step 12 this mode allows you to turn the hypoglycemia indicator (possible low blood sugar) on or off and to select the desired level for the indicator. You will be alerted any time your test result is lower than the selected level. On pressing the ◀ or ▶ button, t...

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    28 www.I-sens.Com www.I-sens.Com 29 setting the strip expiration date indicator step 1 entering the expiration date setting press and hold the ◀ and ▶ buttons at the same time for 3 seconds to enter the expiration date settings. After all segments flash across the screen, 'ep' will show up. Step 2 s...

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    30 www.I-sens.Com www.I-sens.Com 31 notes: • use the caresens pro control solutions and ketosens control solutions only with their corresponding test strips. The control solutions are available for purchase separately. • check the expiration date printed on the bottle. • make sure your meter, test s...

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    32 www.I-sens.Com www.I-sens.Com 33 step 4 waiting for the result the display segments will rotate clockwise and a test result will appear after the meter counts down from 5 to 1 if you test with caresens pro test strip and caresens pro control solution. In case of ketosens test strip and ketosens c...

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    34 www.I-sens.Com www.I-sens.Com 35 caution: to avoid infection when drawing a sample, do not use a lancet more than once, and: • do not use a lancet that has been used by others. • always use a new sterile lancet. • keep the lancing device clean. Note: repeated puncturing at the same sample site ma...

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    36 www.I-sens.Com www.I-sens.Com 37 step 5 the lancing device has seven puncture depth settings, numbered 1 through 7 (1 for a shallow puncture, 7 for a deeper puncture). Choose a depth by rotating the top portion of the adjustable tip until the desired number aligns with the arrow. Step 6 to cock t...

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    38 www.I-sens.Com www.I-sens.Com 39 remove the device from the finger. Wait a few seconds for a blood drop to form. You need a minimum volume of 0.4 microliter for blood glucose test with caresens pro test strip and 0.5 microliter for blood β-ketone test with ketosens test strip. (actual size of 0.5...

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    40 www.I-sens.Com www.I-sens.Com 41 step 11 you can attach a flag to a blood glucose test result to indicate particular situations while the strip is still in the meter. When the result is displayed right after a test, press ◀ or ▶ button to select a pre-meal flag ( ), a post-meal flag ( ), or a fas...

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    42 www.I-sens.Com www.I-sens.Com 43 before using ast, please consult your healthcare professional. Alternative site testing (for glucose only) what is ast (alternative site testing)? Usually, we take the blood sample from the tip of the finger. However, since there are many nerve endings in the fing...

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    44 www.I-sens.Com www.I-sens.Com 45 ast precautions • before using ast, please consult your healthcare professional. • do not use ast for your blood β-ketone test. • do not ignore the symptoms of hyperglycemia or hypoglycemia. • when the results of the test do not reflect your opinion, retest using ...

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    46 www.I-sens.Com www.I-sens.Com 47 target blood glucose ranges 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 expected values : the range of a normal fasting* blood g...

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    48 www.I-sens.Com www.I-sens.Com 49 step 3 viewing pre-meal averages repeatedly press the ◀ button to view 1, 7, 14, 30 and 90-day average values and the number of tests performed pre-meals with the symbol for the last test period. Step 4 viewing post-meal averages press the ◀ button to view 1, 7, 1...

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    50 www.I-sens.Com www.I-sens.Com 51 step 1 press any 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 test results stored in memory step 2 ...

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    52 www.I-sens.Com www.I-sens.Com 53 step 1 without inserting a test strip, press the ◀ and s buttons simultaneously for 3 seconds to enter the time alarm mode. ‘alarm1’ will be displayed while ‘off’ blinks on the screen. Step 2 on pressing the ▶ button, ‘alarm1’ is set and ‘on’ is displayed on the s...

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    54 www.I-sens.Com www.I-sens.Com 55 understanding error messages a used test strip was inserted. > repeat the test with a new 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 appl...

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    56 www.I-sens.Com www.I-sens.Com 57 problem troubleshooting • check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely into the test strip port. • check if the appropriate test strip was used. • check whether the batteries are inserted...

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    58 www.I-sens.Com www.I-sens.Com 59 within run precision blood avg. 2.5 mmol/l 0.1 mmol/l blood avg. 4.3 mmol/l 0.2 mmol/l blood avg. 6.9 mmol/l cv = 4.2% blood avg. 10.3 mmol/l cv = 3.3% blood avg. 16.3 mmol/l cv = 3.0% precision: the precision studies were performed in a laboratory using caresens ...

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    60 www.I-sens.Com www.I-sens.Com 61 difference averages no interferent interval 1 interval 2 2.8–5.5 mmol/l 13.9–19.4 mmol/l 20 glutathione (red) -0.05 mmol/l -0.8 % 21 hemoglobin -0.31 mmol/l -2.8 % 22 ibuprofen 0.09 mmol/l -0.9 % 23 icodextrin -0.15 mmol/l -0.4 % 24 l-dopa -0.13 mmol/l 0.0 % 25 me...

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    62 www.I-sens.Com www.I-sens.Com 63 warranty information manufacturer’s warranty i-sens, inc. Warrants that the caresens dual 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 n...

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    64 www.I-sens.Com www.I-sens.Com 65 memo memo.

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    66 www.I-sens.Com memo.