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KETONE

Blood

-Ketone Monitoring System

User Manual

•

-Ketone Measurement

•

2.5’’ Large, Backlit Display

•

Strip Ejector for Easy

Ejection of Used Test Strips

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

Содержание KetoSens

Страница 1: ...Display Strip Ejector for Easy Ejection of Used Test Strips 2022 i SENS Inc All Rights Reserved PKTAA 0000008 REV0 2022 11 i SENS Inc 43 Banpo daero 28 gil Seocho gu Seoul 06646 Korea www i sens com...

Страница 2: ...st 8 seconds with a small 0 5 L blood sample Welcome to the KetoSens Blood Ketone Monitoring System No part of this document may be reproduced in any form or by any means without the prior written con...

Страница 3: ...Checking the System 20 Control Solution Testing 21 Comparing the Control Solution Test Results 24 Testing Using the Lancing Device 25 Preparing the Lancing Device 26 Preparing the Meter and Test Stri...

Страница 4: ...g outside the body in vitro by people with diabetic ketoacidosis at home or professional healthcare settings as an aid to monitor the effectiveness of diabetic ketoacidosis control Do not use the syst...

Страница 5: ...d sample The KetoSens Blood Ketone Meter is designed to minimise code related errors in monitoring by using the no coding function The KetoSens Blood Ketone Meter should be used only with the KetoSens...

Страница 6: ...Relative humidity Test strip 10 90 Product specifications Measurement range 0 1 8 0 mmol L Sample size Minimum 0 5 L Test time 8 seconds Sample type Fresh capillary whole blood Fresh venous whole blo...

Страница 7: ...cable for data management software can be ordered separately Please contact your authorised i SENS sales representative KetoSens Blood Ketone Monitoring System includes the following items KetoSens Bl...

Страница 8: ...ep 1 Make sure the meter is turned off Push the cover in the direction of the arrow to open the battery compartment Step 2 Remove the used batteries one at a time Slip your index finger under the batt...

Страница 9: ...er into the meter s test strip port Do not drop the meter or submit it to strong shock Do not try to fix or alter the meter in any way Store all the meter components in the portable case to prevent lo...

Страница 10: ...utomatically absorbs the small blood sample applied to the narrow edge of the strip Contact bars Gently push the test strip with its contact bars facing upwards into the test strip port of meter Confi...

Страница 11: ...4 30 C and 10 90 relative humidity Do not freeze Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original box Open the foil test strip packet to ta...

Страница 12: ...ults 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 sep...

Страница 13: ...me alarm has been set mmol L unit for measurinig blood Ketone KETONE appears when the KetoSens strip is inserted and when the test results are saved or displayed Battery symbol indicated meter battery...

Страница 14: ...o scroll faster Adjusting the Date and Time Step 1 Entering SET Mode Press and hold the S button for 3 seconds to enter SET mode After all the segments flash across the screen the SET will show up Pre...

Страница 15: ...p Step 4 Setting the Date Press the or button until the screen displays the correct date Press the S button to confirm the date and to go to the next step Step 5 Setting the Time Format The meter can...

Страница 16: ...or button until the correct hour appears After the hour is set press the S button to go to the next step Step 7 Setting the Minute Press the or button until the correct minute appears After setting t...

Страница 17: ...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 bloo...

Страница 18: ...screen will display On or OFF Press and hold the S button to confirm the strip expiration date indicator and turn the meter off Turning on the Strip Expiration Date Indicator Note If the pre set expi...

Страница 19: ...ill 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 Expi...

Страница 20: ...ox of test strips you may conduct a control solution test following the procedure on pages 21 23 Note Use only the KetoSens Control Solution available for purchase separately Check the expiration date...

Страница 21: ...ctivate the Control Solution Test Mode This will also flag the control solution test result To undo the control solution flag press and hold the button for another 3 seconds You may do a control solut...

Страница 22: ...not included in the averages Step 3 Applying Control Solution to Test Strip Shake the KetoSens Control Solution bottle well before each test Remove the cap and squeeze the bottle to discard the first...

Страница 23: ...rip box is for the KetoSens Control Solution only It has nothing to do with your blood Ketone level Step 5 Compare the result displayed on the meter to the range printed on the test strip box The resu...

Страница 24: ...s 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 c...

Страница 25: ...the Lancing Device You will need a lancing device in order to collect a blood sample You may use the lancing device that is included in the KetoSens Blood Ketone Monitoring System or any other medica...

Страница 26: ...tip Step 3 Firmly insert a new lancet into the lancet holder Hold the lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip Step 4 Turn...

Страница 27: ...ng device hold the body of lancing device in one hand and pull the sliding barrel with the other hand The device is loaded when you feel a click and the load confirmation window turns red Note The ski...

Страница 28: ...st 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 will appear on the screen...

Страница 29: ...eded to fill the confirmation window actual size of 0 5 L Step 9 After the symbol appears on the screen apply the blood sample to the narrow end of the test strip till the meter beeps If the confirmat...

Страница 30: ...insert it and apply blood sample after symbol appears on the screen Step 10 The test result will appear after the meter counts down from 8 to 1 The result will be automatically stored in the meter s m...

Страница 31: ...et into the saved protective disk Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container Discarding Used Lancets Caution The lancet is for single...

Страница 32: ...lays results between 0 1 8 0 mmol L HI appears when the blood Ketone level is greater than 8 0 mmol L If HI is displayed again upon retesting please contact your healthcare professional immediately Lo...

Страница 33: ...e KetoSens meter can save up to 1 000 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 c...

Страница 34: ...e number of tests performed for the last test period button button Average 1 7 14 30 90 days Note The control solution test results saved with are not included in the averages Step 3 Use the button to...

Страница 35: ...followed by the 1 day average value and the number of the test results saved within the current day Step 2 Use the button to scroll through the test results starting from the most recent and ending w...

Страница 36: ...d on the screen Press the button again to cancel alarm 1 OFF will blink on the screen Step 3 Press the button while On blinks to adjust the time of alarm 1 A number indicating the hour will blink on t...

Страница 37: ...ng the minute will start blinking Press the button to set the minute Step 5 Press the S button to finish and to go to alarm 2 mode Repeat steps 2 to 4 to set the remaining time alarms alarm 2 3 Step 6...

Страница 38: ...ing 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 cont...

Страница 39: ...he test Repeat the test after inserting a new test strip Do not use the meter Contact your authorised i SENS sales representative Repeat the test with a new test strip If the error message persists co...

Страница 40: ...e the batteries Check if the confirmation window is filled completely Repeat the test with a new test strip Repeat the test with a new test strip Check the expiration date of the test strip Perform co...

Страница 41: ...patients with those obtained using a Randox Monaco a laboratory instrument The following results were obtained by diabetic patients at clinic centers Within Run Precision 0 4 mmol L SD 0 027 mmol L 1...

Страница 42: ...he given concentrations does not affect blood ketone measurements Higher concentrations of the substances shown below may cause inaccurate blood ketone results No Interferent Concentration 1 Acetamino...

Страница 43: ...Heparin 8000 U dL 17 Ibuprofen 1 94 mmol L 18 L Dopa L 3 4 dihydroxyphenylalanine 0 25 mmol L 19 Maltose 29 21 mmol L 20 Methyl DOPA 0 47 mmol L 21 Salicylate 4 34 mmol L 22 Tetracycline 0 68 mmol L...

Страница 44: ...ndling 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 w...

Страница 45: ...www i sens com 45 MEMO...

Страница 46: ...46 www i sens com MEMO...

Страница 47: ...www i sens com 47 MEMO...

Страница 48: ...48 www i sens com MEMO...

Страница 49: ...www i sens com 49 MEMO...

Страница 50: ...50 www i sens com MEMO...

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