i-SENS KetoSens Manual
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i-SENS KetoSens Manual

Blood beta-ketone monitoring system
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Information
Important Information: Read This First! ..............................................4
Specifications .....................................................................................8
KetoSens Blood β-Ketone Monitoring System ..................................9
Inserting or Replacing the Batteries .................................................10
KetoSens Blood β-Ketone Test Strip ...............................................11
KetoSens Blood β-Ketone Meter .....................................................13
KetoSens Blood β-Ketone Meter Display .........................................14
Preparation
Setting Up Your System ...................................................................15
Adjusting the Date and Time .........................................................15
Setting the Sound On/OFF............................................................18
Turning on the Strip Expiration Date Indicator ..............................19
Setting the Strip Expiration Date Indicator .......................................20
Checking the System .......................................................................21
Control Solution Testing ...............................................................22
Comparing the Control Solution Test Results ..............................24
Testing
Using the Lancing Device .................................................................25
Preparing the Lancing Device .......................................................26
Preparing the Meter and Test Strip ...............................................28
Applying Blood Sample.................................................................28
Discarding Used Lancets ..............................................................30
HI Message .......................................................................................32
Additional Functions
Meter Memory ..................................................................................33
Setting the Alarm Function ...............................................................35
Setting the Time Alarms (alarm 1-3) .............................................35
Caring for Your System ....................................................................37
Maintenance
Understanding Error Messages ........................................................42
General Troubleshooting ..................................................................45
Performance Characteristics ............................................................46
Warranty Information ........................................................................48

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  • Page 1: Table Of Contents

    Table of Contents Information Important Information: Read This First! ..........4 Specifications ..................8 KetoSens Blood β-Ketone Monitoring System ........9 Inserting or Replacing the Batteries ..........10 KetoSens Blood β-Ketone Test Strip ..........11 KetoSens Blood β-Ketone Meter .............13 KetoSens Blood β-Ketone Meter Display .........14 Preparation Setting Up Your System ..............15...

  • Page 2: Important Information: Read This First

    This system is intended to be used by a single person and for Transmitting Bloodborne Pathogens: Initial should not be shared. Communication” (2010) http://wayback.archive-it. The KetoSens Blood β-Ketone Test Strips work with the org/7993/20170111013014/http://www.fda.gov/ KetoSens Blood β-Ketone Meter to quantitatively measure MedicalDevices/Safety/AlertsandNotices/ucm224025.htm Blood β-Ketone in capillary whole blood samples drawn...
  • Page 3 β-Ketone in the blood sample. (3000 meters). • The KetoSens Blood β-Ketone Meter is designed to • Do not use when hematocrit is outside the acceptable minimise code related errors in monitoring by using hematocrit range for testing of 20 % to 55 %.

  • Page 4: Specifications

    106 x 58 x 17 (mm) Weight 71.8 g (with batteries) Operating ranges Temperature 50–104 ˚F (10–40 ˚C) The KetoSens Blood β-Ketone Control Solution Level A and Relative humidity 10–90 % B are sold separately and can be purchased by contacting Hematocrit 20–55 % Customer Service.

  • Page 5: Inserting Or Replacing The Batteries

    KetoSens Blood β-Ketone Test Strip Inserting or Replacing the Batteries The KetoSens Meter uses two 3.0 V lithium batteries. The KetoSens blood β-Ketone monitoring system measures Before using the meter, check the battery compartment and blood β-Ketone quickly and accurately. It automatically insert batteries if empty.

  • Page 6: Ketosens Blood Β-Ketone Meter

    KetoSens Blood β-Ketone Meter Data Port Warning: Used to transfer data • The KetoSens test strip should be used only with fresh from the meter to a capillary whole blood samples drawn from the fingertip. computer with • Do not reuse test strips.

  • Page 7: Ketosens Blood Β-Ketone Meter Display

    Press the ◀ or ▶ button to KETONE: appears when the KetoSens strip is inserted, select 'YES' and press the S and when the test results are saved or displayed button to go to the next step.
  • Page 8 12-hour or the 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. 16 www.i-sens.com www.i-sens.com 17...

  • Page 9: Setting The Sound On/Off

    If the expiration date is set to October of 2022, the meter Note: will display 'EP' at the symbol is displayed only when the sound is set to beginning of November, 2022. OFF. 18 www.i-sens.com www.i-sens.com 19...

  • Page 10: Setting The Strip Expiration Date Indicator

    KetoSens test strip box. Compare the result displayed The strip expiration date is printed on the test strip box. on the meter to the KetoSens Control Solution range printed on the test strip box. Before using a new meter or a new box of test strips, you should...

  • Page 11: Control Solution Testing

    Then wipe the tip with a clean The range printed on the test strip box is for the KetoSens tissue or cloth. Dispense a drop Control Solution only. It has nothing to do with your blood of control solution onto a clean β-Ketone level.

  • Page 12: Comparing The Control Solution Test Results

    37. 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 Customer...

  • Page 13: Preparing The Lancing Device

    The lancing aligned with the load confirmation device's adjustable tip allows the best depth of skin window and release button as shown penetration for an adequate sample size. in the diagram. 26 www.i-sens.com www.i-sens.com 27...

  • Page 14: Preparing The Meter And Test Strip

    Remove the device from the finger. Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is needed to fill the confirmation window (actual size of 0.5 µL : 28 www.i-sens.com www.i-sens.com 29...

  • Page 15: Discarding Used Lancets

    • Keep the lancets in a cool and dry place. Step 1 • The lancet is for single use only. Never share or reuse Unscrew the lancing device tip. a lancet. Always dispose of lancets properly. 30 www.i-sens.com www.i-sens.com 31...

  • Page 16: Hi Message

    HI Message Meter Memory The KetoSens meter can save up to 1,000 β-Ketone test HI Message results with time and date. If the memory is full, the oldest The meter displays results between test result will be deleted and the latest test result will be 0.1–8.0 mmol/L.

  • Page 17: Setting The Alarm Function

    Setting the Alarm Function Three types of alarms can be set in the KetoSens Meter. Step 2 The alarms ring for 15 seconds and can be silenced by Use the ▶ button to scroll pressing any button or by inserting a test strip.

  • Page 18: Caring For Your System

    Press and hold the S button for 3 seconds to finish and Note: The life span of a KetoSens meter is 5 years. We turn the meter off. recommend cleaning and disinfecting both the meter and lancing device at least once per week. We have validated...
  • Page 19 • We have validated Clorox Healthcare Bleach Germicidal Wipes with 0.55 % sodium hypochlorite as the active ① Open the cap of the ingredient, for disinfecting the KetoSens meter and lancing Clorox Healthcare device. It has been shown to be safe for use with the Bleach Germicidal meter and lancing device.
  • Page 20 Customer Service Center: • When control solution test results do not fall within the 1-800-429- 5001 (9 am–9 pm EST, Monday–Saturday). At stated range on the test strip box. all other times, contact your healthcare professional. 40 www.i-sens.com www.i-sens.com 41...

  • Page 21: Understanding Error Messages

    This error message Repeat the test after may appear when inserting a KetoSens The blood or control Repeat the test with the wrong blood test strip. solution sample was a new test strip and β-Ketone test strip...

  • Page 22: General Troubleshooting

    • Perform control solution test. Note: If the problem is not resolved, please contact Customer Service: 1-800-429-5001 Mon–Sat, 9 am–9 pm EST. At all other times or in case of emergency, contact your healthcare professional or emergency medical response. 44 www.i-sens.com www.i-sens.com 45...

  • Page 23: Performance Characteristics

    KetoSens Brand of BKM Systems. System has been evaluated in laboratory and in clinical tests. Within Run Precision Accuracy: The accuracy of the KetoSens BKM System was Blood avg. 0.4 mmol/L SD = 0.027 mmol/L assessed by comparing blood β-Ketone results obtained Blood avg.

  • Page 24: 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 25 MEMO www.i-sens.com 49...
  • Page 26 MEMO 50 www.i-sens.com...
  • Page 27 MEMO β-Ketone Measurement for Type 1 Diabetic Users Lo–0.5 mmol/L 1.5–3.0 mmol/L Re-test for blood ketones only if the blood Refer to medical sta for assessment for glucose levels are higher than 120 mg/dL. DKA*. Re-test blood glucose and ketone Revert to routine blood glucose monitoring.
  • Page 28 MEMO Keto Diet Ketone Blood Level Ranges 10.0 (mmol/L) Not ‘Ketosis’ (Lo–0.5 mmol/L) Starvation Ketosis (3.0–5.0 mmol/L)* Nutritional Ketosis (0.5–1.5 mmol/L) Possible Ketoacidosis (5.0 mmol/L and higher)* Optimal Ketosis (1.5–3.0 mmol/L) * May require medical attention. Please check with your medical provider. References: http://www.diabetes.co.uk/keto/measuring-ketosis-on-a-keto-diet.html http://litfl.com/ketoacidosis/ http://www.nhs.uk/conditions/diabetic-ketoacidosis/...

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