i-SENS KetoSens User Manual
  1. Manuals
  2. Brands
  3. i-SENS Manuals
  4. Measuring Instruments
  5. KetoSens
  6. User manual

i-SENS KetoSens User Manual

Blood b-ketone monitoring system
Hide thumbs Also See for KetoSens:
Table of Contents

Advertisement

Quick Links

i-SENS, Inc.
43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea
www.i-sens.com
© 2022 i-SENS, Inc. All Rights Reserved
PKTAA-0000008 REV0 2022-11
Medical Technology Promedt
Consulting GmbH
Altenhofstrasse 80
66386 St. Ingbert, Germany
User Manual
Blood β-Ketone Monitoring System
β-Ketone Measurement
•
2.5'' Large, Backlit Display
•
Strip Ejector for Easy
•
Ejection of Used Test Strips
KETONE

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the KetoSens and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for i-SENS KetoSens

Summary of Contents for i-SENS KetoSens

  • Page 1 Strip Ejector for Easy • Ejection of Used Test Strips i-SENS, Inc. Medical Technology Promedt Consulting GmbH 43, Banpo-daero 28-gil, KETONE Altenhofstrasse 80 Seocho-gu, Seoul 06646, Korea www.i-sens.com 66386 St. Ingbert, Germany © 2022 i-SENS, Inc. All Rights Reserved PKTAA-0000008 REV0 2022-11...
  • Page 2 Welcome to the KetoSens Blood β-Ketone Monitoring System Thank you for choosing the KetoSens Blood β-Ketone Monitoring System. The system provides you with rapid and convenient blood β-Ketone in vitro (i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 8 seconds with a small (0.5 μL) blood sample.

  • 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

    Please note the following instructions: Intended use: The KetoSens Blood β-Ketone Monitoring System is used with the KetoSens Blood β-Ketone Meter for quantitatively measuring ketone in whole blood. The KetoSens Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro)
  • Page 5 (in vitro diagnostic use). • β-Ketone in blood samples 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. •...

  • Page 6: Specifications

    71.8 g (with batteries) Operating ranges Temperature 10–40 ˚C Relative humidity 10–90 % Hematocrit 20–60 % Storage/transport conditions Temperature Meter (with batteries) 0–50 ˚C Test Strip 4–30 ˚C Control solution 8–30 ˚C Relative humidity Test strip 10–90 % 6 www.i-sens.com...

  • Page 7: Ketosens Blood Β-Ketone Monitoring System

    * Batteries * Logbook * Carrying Case • Check all the components after opening the KetoSens blood β-Ketone monitoring system package. The exact contents are listed on the main box. • The cable for data management software can be ordered separately.

  • Page 8: Inserting Or Replacing The Batteries

    Inserting or Replacing the Batteries The KetoSens 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. The test results may not be saved if the batteries run out.

  • Page 9: Caring For Your System

    If you need to throw your meter away, you should follow existing policies and procedures of your own country or region. For information about correct disposal, please contact your local council or authority. If you need assistance, contact your authorised i-SENS sales representative or visit www.i-sens.com. www.i-sens.com 9...

  • Page 10: Ketosens Blood Β-Ketone Test Strip

    KetoSens Blood β-Ketone Test Strip The KetoSens 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. Contact bars Gently push the test strip, with its...
  • Page 11 Warning! • The KetoSens Blood β-Ketone Test Strips should be used with fresh capillary whole blood samples, or with fresh venous whole blood samples if drawn by healthcare professionals. • Do not reuse test strips. • Do not use test strips past the expiration date.

  • Page 12: Ketosens Blood Β-Ketone Meter

    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. 12 www.i-sens.com...

  • Page 13: Ketosens Blood Β-Ketone Meter Display

    β-Ketone 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...

  • Page 14: Setting Up Your System

    Step 2 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. 14 www.i-sens.com...
  • Page 15 24-hour clock format. Press the ◀ or ▶ button to select a format. The AM•PM symbol is not displayed in the 24-hour format. After selecting the format, press the S button to go to the next step. www.i-sens.com 15...
  • Page 16 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 the minute, press the S button to go to the next step. 16 www.i-sens.com...

  • Page 17: 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. www.i-sens.com 17...

  • Page 18: Turning On The Strip Expiration Date Indicator

    'EP' when the test strip is inserted and when the test result is displayed right after the test. If the expiration date is set to October of 2024, the meter will display 'EP' at the beginning of November, 2024. 18 www.i-sens.com...

  • Page 19: Setting The Strip Expiration Date Indicator

    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. www.i-sens.com 19...

  • Page 20: Checking The System

    β-Ketone and is used to check that the meter and the test strips are working properly. KetoSens Control Solution ranges are printed on the KetoSens test strip box. Compare the result displayed on the meter to the KetoSens Control Solution range printed on the test strip box.

  • Page 21: Control Solution Testing

    Press and hold the ▶button for 3 seconds to activate 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. www.i-sens.com 21...
  • Page 22 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 drop. Then wipe the tip with a clean tissue or cloth. Dispense a drop of control solution onto a clean non-absorbent surface.
  • Page 23 Control M : X.X–X.X mmol/L Used strips should be discarded safely in appropriate containers. Caution: The range printed on the test strip box is for the KetoSens Control Solution only. It has nothing to do with your blood β-Ketone level. Note: The Control Solution can be purchased separately.

  • Page 24: Comparing The Control Solution Test Results

    If results continue 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. 24 www.i-sens.com...

  • Page 25: Using The Lancing Device

    Using 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 β-Ketone Monitoring System or any other medically approved lancing device.

  • Page 26: Preparing The Lancing Device

    Save disk to recap lancet after use. Replace lancing device tip. Step 4 Turn the adjustable tip until it is aligned with the load confirmation window and release button as shown in the diagram. 26 www.i-sens.com...
  • Page 27 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. www.i-sens.com 27...

  • Page 28: Preparing The Meter And Test Strip

    Insert a test 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. 28 www.i-sens.com...

  • Page 29: Applying Blood Sample

    (thickness 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. Good Sample Insufficient Sample www.i-sens.com 29...
  • Page 30 8 to 1. The result will be automatically stored in the meter’s memory. If the test strip is removed after the test result is displayed, the meter will automatically switch off after 3 seconds. Discard used test strips safely in appropriate containers. 30 www.i-sens.com...

  • Page 31: Discarding Used Lancets

    Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container. Caution: The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. www.i-sens.com 31...

  • Page 32: Hi And Lo Messages

    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. Lo Message 'Lo' appears when a test result is less than 0.1 mmol/L. 32 www.i-sens.com...

  • Page 33: Meter Memory

    Meter Memory 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.
  • Page 34 Step 3 Use the ▶ button to scroll back through the averages seen previously. Press the S button to turn off the meter. Note: The control solution test results saved with ' ' are not included in the averages. 34 www.i-sens.com...

  • Page 35: Viewing Test Results Stored In Memory

    ▶ result seen previously. After checking the stored test results, press the S button to turn off the meter. Note: The control solution test results saved with will be displayed with when you review the stored test results. www.i-sens.com 35...

  • Page 36: Setting The Alarm Function

    Setting the Alarm Function Three types of alarms can be set in the KetoSens Meter. The alarms ring for 15 seconds and can be silenced by pressing any button or by inserting a test strip. Setting the Time Alarms (alarm 1–3) Step 1 Without inserting a test strip, press the ◀...
  • Page 37 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 Press the S button for 3 seconds to finish and turn the meter off. www.i-sens.com 37...

  • Page 38: Understanding Error Messages

    Move to an area where during the test was the temperature is above or below the within the operating operating range. range 10–40 ˚C and repeat the test after the meter and test strips have reached a temperature within the operating range. 38 www.i-sens.com...
  • Page 39 Repeat the test after This error message inserting a KetoSens may appear when the test strip. wrong blood β-Ketone test strip is used instead of the KetoSens Blood β-Ketone test strip.

  • Page 40: General Troubleshooting

    • Repeat the test with a new test strip. The test result doesn't • Check the expiration date of the test match the way you strip. feel. • Perform control solution test. Note: If the problem is not resolved, please contact your authorised i-SENS sales representative. 40 www.i-sens.com...

  • Page 41: Performance Characteristics

    Performance Characteristics System Accuracy and Measurement Precision The performance of KetoSens Blood β-Ketone Monitoring System has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the KetoSens Blood β-Ketone Monitoring System (Model GM01GAA) was assessed by comparing blood β-Ketone results obtained by patients with those obtained...

  • Page 42: Influence Quantities

    1.32 mmol/L Acetoacetate 0.98 mmol/L Acetone 10.33 mmol/L Ascorbic acid 0.17 mmol/L Bilirubin (unconjugated) 0.34 mmol/L Captopril 0.46 mmol/L Cholesterol 12.93 mmol/L Creatinine 2.65 mmol/L Dopamine 0.85 mmol/L EDTA 6.84 mmol/L Galactose 3.33 mmol/L Gentisic acid 3.24 mmol/L 42 www.i-sens.com...
  • Page 43 Heparin 8000 U/dL Ibuprofen 1.94 mmol/L L-Dopa 0.25 mmol/L (L-3,4-dihydroxyphenylalanine Maltose 29.21 mmol/L Methyl-DOPA 0.47 mmol/L Salicylate 4.34 mmol/L Tetracycline 0.68 mmol/L Tolbutamide 3.70 mmol/L Tolazamide 3.21 mmol/L Triglycerides 33.87 mmol/L Uric acid 1.19 mmol/L Xylose 1.67 mmol/L www.i-sens.com 43...

  • Page 44: Warranty Information

    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 five (5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter.
  • Page 45 MEMO www.i-sens.com 45...
  • Page 46 MEMO 46 www.i-sens.com...
  • Page 47 MEMO www.i-sens.com 47...
  • Page 48 MEMO 48 www.i-sens.com...
  • Page 49 MEMO www.i-sens.com 49...
  • Page 50 MEMO 50 www.i-sens.com...

Table of Contents