i-SENS KetoSens Owner'S Booklet Download Page 1

Page: 1 / 23

KETONE

Blood

-Ketone Monitoring System

Owner’s Booklet

•

-Ketone Measurement

• 2.5’’ Large, Backlit Display
• Strip Ejector for Easy

Ejection of Used Test Strips

Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80,
66386 St. Ingbert, Germany

i-SENS, Inc.

43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea

Summary of Contents for KetoSens

Page 1: ...arge Backlit Display Strip Ejector for Easy Ejection of UsedTest Strips 2019 i SENS Inc All Rights Reserved PKTAA 0000003 REV0 2019 09 Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany i SENS Inc 43 Banpo daero 28 gil Seocho gu Seoul 06646 Korea ...

Page 2: ...in just 8 seconds with a small 0 5 μL blood sample WelcometotheKetoSens Bloodβ KetoneMonitoringSystem 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 one of co...

Page 3: ...tting the Strip Expiration Date Indicator 19 Checking the System 20 Control Solution Testing 21 Comparing the Control Solution Test Results 23 Testing Using the Lancing Device 24 Preparing the Lancing Device 25 Preparing the Meter and Test Strip 27 Applying Blood Sample 28 Discarding Used Lancets 30 HI Message 31 Additional Functions Meter Memory 32 Viewing Averages Stored in Memory 32 Viewing Tes...

Page 4: ...es reacts with the chemical in the test strip to produce a small electrical current The KetoSens meter detects this electrical current and measures the amount of β Ketone in the blood sample The KetoSens Blood β Ketone Meter is designed to minimise code related errors in monitoring by using the no coding function The KetoSens Blood β Ketone Meter should be used only with the KetoSens Test Strips A...

Page 5: ...2 122 F Test Strip 4 30 C 39 86 F Control solution 8 30 C 46 86 F Relative humidity Test strip 10 90 Product specifications Measurement range 0 1 8 0 mmol L Sample size Minimum 0 5 µL Test time 8 seconds Sample type Fresh capillary whole blood Fresh venous whole blood healthcare professionals only Assay method Electrochemical Battery life 3 000 tests Power Two 3 0 V lithium batteries disposable ty...

Page 6: ...tem Use a 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 or 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 bl...

Page 7: ...strips Do not use test strips past the expiration date Test strips in new unopened test strip box can be used up until the expiration date printed on the foil packet if the test strips are used and stored according to its storage and handling methods Store test strips in a cool and dry place at a temperature between 4 30 C 39 86 F Keep test strips away from direct sunlight or heat and do not freez...

Page 8: ...e Meter Data Port Used to transfer data from the meter to a computer with a cable Button Turns the meter on selects or changes information Display Shows results and messages S Button Turns the meter on off confirms menu selections and changes information Test Strip Port Insert test strip here Note The cable for data management software can be ordered separately Please contact your authorised i SEN...

Page 9: ...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 3 Setting the Month A number indicating the month will blink on the screen Press the or button until the correct month appears Press the S button to confirm your selection and to go to the next step Step 4 Setting the Date Press the...

Page 10: ...OFF Press the S button to confirm the selection The meter will beep in the following instances if the sound is set to On When you press a button to turn on the meter When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When it is time for a pre set blood glucose test If the sound is set to OFF none ...

Page 11: ...ing the Month A number indicating the month will blink at the bottom of the screen Press the or button until the correct month appears Press and hold the S button for 3 seconds to confirm the month and turn off the meter 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...

Page 12: ...e 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 Whenever you open a new box of test strips If the meter or test strips do not function properly Control Solution Testing Step 2 Shak...

Page 13: ...tinue to fall outside the range printed on the test strip box the KetoSens Test Strip and Meter may not be working properly Do not use your system and contact your authorised i SENS sales representative Situations When the control solution bottle was not shaken well When the meter test strip or the control solution were exposed to high or low temperatures When the first drop of the control solutio...

Page 14: ...vice 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 cloth or tissue may be used Step 1 Wash hands and sample site with soap and warm water Rinse and dry thoroughly Step 2 Unscrew and remove the lancing device tip Step3 Firmly insert a new lancet into the ...

Page 15: ...oaded when you feel a click and the load confirmation window turns red Note The skin depth to get blood samples will vary 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 Step 7 Insert a test strip with the contact bars facing upwards into the meter s test strip port Push the strip in gently un...

Page 16: ...hickness 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 Applying Blood Sample Good Sample Insufficient Sample 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 a...

Page 17: ...d Lancets Caution The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly HI Message HI Message The meter displays results between 0 1 8 0 mmol L HI appears when the blood β Ketone level is greater than 8 0 mmol L If HI is displayed again upon retesting please contact your healthcare professional immediately Note In case of blood β ketone test 0 0 mmol L ...

Page 18: ...d for the last test period button button The KetoSens meter can save up to 1 000 β Ketone test results with time and date If the memory is full the oldest test result will be deleted and the latest test result will be stored The KetoSens meter calculates and displays the averages of total test results from the last 1 7 14 30 and 90 days Thenumber oftests withinthe currentday Average 1 7 14 30 90da...

Page 19: ...ff the meter ViewingTest Results Stored in Memory Thenumberof testswithinthe currentday button button Step 1 Without inserting a test strip press the and S buttons simultaneously for 3 seconds to enter the time alarm setting alarm 1 will be displayed while OFF blinks on the screen Step 2 On pressing the button alarm 1 is set and On is displayed on the screen Press the button again to cancel alarm ...

Page 20: ...ns A used test strip was inserted The temperature during the test was above or below the operating range WhatTo Do Repeat the test with a new test strip Understanding Error Messages 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 Move to an area w...

Page 21: ...strip Repeat the test after inserting a KetoSens test strip Problem Troubleshooting Check whether the test strip is inserted with the contact bars facing upwards 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 with the side facing upwards Replace the batteries Check if the confirmation wi...

Page 22: ...rol avg 2 3 mmol L CV 3 8 Control avg 3 9 mmol L CV 4 3 Thisstudyshowsthattherecouldbeavariationofupto4 3 Slope 0 9821 Y intercept 0 0094 mmol L Correlation coefficient r 0 9969 Number of sample 100 Range tested 0 03 7 86 mmol L Warranty Information Manufacturer s Warranty i SENS Inc warrants that the KetoSens Meter shall be free of defects in material and workmanship in normal use for a period of...

Page 23: ...42 www i sens com MEMO ...

Search results

Summary of Contents for KetoSens

Reviews:

Related manuals for KetoSens

Brands by name

Popular brands

i-SENS KetoSens, Owner'S Booklet

Search results

Summary of Contents for KetoSens

Reviews:

Related manuals for KetoSens

Brands by name

Popular brands