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i-SENS, Inc.
43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea
© 2019 i-SENS, Inc. All Rights Reserved PKTAA-0000003 REV0 2019/09
Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80,
66386 St. Ingbert, Germany
Owner's Booklet
Blood β-Ketone Monitoring System
• β-Ketone Measurement
• 2.5'' Large, Backlit Display
• Strip Ejector for Easy
Ejection of Used Test Strips
KETONE
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Summary of Contents for i-SENS KetoSens
- Page 1 • Strip Ejector for Easy Ejection of Used Test Strips Medical Technology Promedt i-SENS, Inc. KETONE Consulting GmbH 43, Banpo-daero 28-gil, Altenhofstrasse 80, Seocho-gu, Seoul 06646, Korea 66386 St. Ingbert, Germany © 2019 i-SENS, Inc. All Rights Reserved PKTAA-0000003 REV0 2019/09...
- Page 2 • 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 continuous...
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Page 3: Table Of Contents
Table of Contents Information Important Information: Read This First! Specifications KetoSens Blood β-Ketone Monitoring System Inserting or Replacing the Batteries Caring for Your System KetoSens Blood β-Ketone Test Strip KetoSens Blood β-Ketone Meter KetoSens Blood β-Ketone Meter Display Preparation Setting Up Your System... -
Page 4: Important Information: Read This First
Important Information: Read This First! For optimum safety and benefits, please read the entire manual • T he KetoSens Blood β-Ketone Monitoring System is contents before using the system. Please note the following intended for self-testing outside the body (in vitro instructions: diagnostic use). -
Page 5: Specifications
Specifications KetoSens Blood β-Ketone Monitoring System Product specifications KetoSens BKM System includes the following items: * KetoSens Blood β-Ketone Meter Measurement range 0.1–8.0 mmol/L * Owner's Booklet Sample size Minimum 0.5 µL * Batteries Test time 8 seconds Optional items: • Fresh capillary whole blood... -
Page 6: Inserting Or Replacing The Batteries
Inserting or Replacing the Batteries Caring for Your System The KetoSens Meter uses two 3.0 V lithium batteries. Use a soft cloth or tissue to wipe the meter exterior. If necessary, Before using the meter, check the battery compartment and dip the soft cloth or tissue in a small amount of alcohol. -
Page 7: Ketosens Blood Β-Ketone Test Strip
KetoSens Blood β-Ketone Test Strip Warning! The KetoSens Blood β-Ketone Monitoring System measures blood β-Ketone quickly and accurately. It automatically absorbs • T he KetoSens Blood β-Ketone Test Strips should be used with the small blood sample applied to the narrow edge of the strip. fresh capillary whole blood samples, or with fresh venous whole blood samples if drawn by healthcare professionals. -
Page 8: Ketosens Blood Β-Ketone Meter Display
KETONE: appears when the KetoSens strip is inserted, and when the test results are saved or displayed Battery symbol: indicated meter battery is running low and needs to be replaced Date Test Strip Port... -
Page 9: Setting Up Your System
Press the ◀ or ▶ button to select a format. to confirm your selection and to go to the The AM•PM symbol is not displayed in the next step. 24-hour format. After selecting the format, press the S button to go to the next step. 14 www.i-sens.com www.i-sens.com 15... -
Page 10: Setting The Sound On/Off
If the sound is set to OFF, none of the sound functions will work. After setting the sound, press the S button to go to the next step. Note: symbol is displayed only when the sound is set to OFF. 16 www.i-sens.com www.i-sens.com 17... -
Page 11: Turning On The Strip Expiration Date Indicator
If the expiration date is set to October of 2021, the meter will display 'EP' at the beginning of November, 2021. 18 www.i-sens.com www.i-sens.com 19... -
Page 12: Checking The System
KetoSens Control Solution ranges are printed on the Control Solution Testing KetoSens test strip box. Compare the result displayed on the meter to the KetoSens Control Solution range printed Step 1 on the test strip box. -
Page 13: Comparing The Control Solution Test Results
(3) months), solution. Caution: • W hen the control solution is The range printed on the test strip box is for the KetoSens contaminated. Control Solution only. It has nothing to do with your blood β-Ketone level. If results continue to fall outside the range printed on the test... -
Page 14: Using The Lancing Device
You will need a lancing device in order to collect a blood sample. Step 1 You may use the lancing device that is included in the KetoSens Wash hands and sample site with Blood β-Ketone Monitoring System or any other medically soap and warm water. -
Page 15: Preparing The Meter And Test Strip
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. 26 www.i-sens.com www.i-sens.com 27... -
Page 16: Applying Blood Sample
(thickness and stickiness) or insufficient in appropriate containers. volume, the Er4 message may appear. It is recommended to place the test strip vertically into the blood sample site as shown below. Good Sample Insufficient Sample 28 www.i-sens.com www.i-sens.com 29... -
Page 17: Discarding Used Lancets
The lancet is for single use only. Never share or Note: In case of blood β-ketone test, 0.0 mmol/L appears reuse a lancet. Always dispose of lancets properly. when a test result is less than 0.1 mmol/L. 30 www.i-sens.com www.i-sens.com 31... -
Page 18: Meter Memory
Meter Memory Step 3 The KetoSens meter can save up to 1,000 β-Ketone test results Use the ▶ button to scroll back through the averages seen with time and date. If the memory is full, the oldest test result previously. -
Page 19: Viewing Test Results Stored In Memory
Setting the Alarm Function Viewing Test Results Stored in Memory Three types of alarms can be set in the KetoSens Meter. The alarms ring for 15 seconds and can be silenced by pressing Step 1 any button or by inserting a test strip. -
Page 20: Understanding Error Messages
15–30 ˚C (59–86 ˚F) and repeat the test after the meter and test strips have reached a temperature within the operating range. 36 www.i-sens.com www.i-sens.com 37... -
Page 21: General Troubleshooting
• C heck if the appropriate test strip This error message Repeat the test after a test strip. was used. may appear when inserting a KetoSens • C heck whether the batteries are the wrong blood test strip. inserted with the + side facing β-Ketone test strip is upwards. -
Page 22: Performance Characteristics
Manufacturer’s Warranty System has been evaluated in laboratory and in clinical tests. i-SENS, Inc. warrants that the KetoSens Meter shall be free of defects in material and workmanship in normal use for a Accuracy: The accuracy of the KetoSens BKM System (Model period of five (5) years. - Page 23 MEMO 42 www.i-sens.com...
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