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Warning:

•   The KetoSens test strip should be used only with fresh 

capillary whole blood samples drawn from the fingertip.

•     Do not reuse test strips.

•     Do not use test strips past the expiration date.

•    Test strips in new, unopened foil packet 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 foil packet in a cool and dry place between 39–86 ˚F 

and 20–80 % Relative Humidity.

•   Keep the foil packet of test strips away from direct sunlight 

or heat.

•   Store unused test strips in their original foil packet to avoid 

damage or contamination.

•   Open the foil packet to take out a test strip for testing and 

use the test strip immediately. Do not use the test strip if 

the foil is damaged or torn.

•   Handle test strips only with clean and dry hands.

•   Do not bend, cut, or alter test strips in any way.

•   For detailed storage and usage information, refer to the 

KetoSens test strip package insert.

•  

Keep the meter and testing supplies away from young children. 

The test strips and foil packet may cause choking hazards. 

Note: 

You can get more safety information at FDA Public Health 

Notification (http://wayback.archive-it.org/7993/20170111013014/

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm224025.htm) or at CDC Clinical Reminder (http://www.cdc.

gov/injectionsafety/Fingerstick-DevicesBGM.html). 

KetoSens Blood 

β

-Ketone 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,

messages

S Button

Turns the 

meter on/off, 

confirms menu 

selections, 

and changes 

information

Test Strip Port

Insert test strip 

here

Note: 

•  The unit of measurement is fixed and it cannot be 

changed by the user.

•  The cable for data management software can be ordered 

separately. Please contact Customer Service: 1-800-429-

5001 (9 am–9 pm EST, Monday–Saturday). 

Test Strip 

Ejector

Slide down to 

discard the used 

strips

Summary of Contents for KetoSens

Page 1: ...tting 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...

Page 2: ...performing correctly Please use this device only for the intended use described in this User s Manual Please follow the suggested cleaning and disinfection procedures described in this User s Manual...

Page 3: ...humidity may affect results For single patient use only For over the counter use Important Information The KetoSens Blood Ketone Monitoring System is intended for self testing outside the body in vitr...

Page 4: ...and B are sold separately and can be purchased by contacting Customer Service Check all the components after opening the KetoSens blood Ketone monitoring system package The exact contents are listed...

Page 5: ...r as shown in the figure on the right Insert two new batteries with the side facing up and make sure the batteries are inserted firmly Step 3 Place the cover on the battery compartment Push down until...

Page 6: ...strips in any way For detailed storage and usage information refer to the KetoSens test strip package insert Keep the meter and testing supplies away from young children The test strips and foil packe...

Page 7: ...to turn off the meter Press the or button to change values Press and hold the or button to scroll faster Adjusting the Date and Time Step 1 Entering SET Mode Press and hold the S button for 3 seconds...

Page 8: ...he date and to go to the next step Step 5 Setting the Time Format The meter can be set in the AM PM 12 hour or the 24 hour clock format Press the or button to select a format The AM PM symbol is not d...

Page 9: ...etting the Sound On OFF Note The symbol is displayed only when the sound is set to OFF Step 9 This setting allows you to turn the strip expiration date indicator on or off This setting turns the funct...

Page 10: ...trol 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 Before using a new meter...

Page 11: ...toms are inconsistent with the blood Ketone test results and you feel that the meter or test strips are not working properly If you drop or damage the meter Note The KetoSens Control Solution can be p...

Page 12: ...ion test by referring to the Notes on page 21 Discard the used control solution and repeat the test using a new bottle of control solution Caution To reduce the chance of infection All components that...

Page 13: ...Device Step 5 The lancing device has six puncture depth settings numbered 0 through 5 0 for a shallow puncture 5 for a deeper puncture Choose a depth by rotating the top portion of the adjustable tip...

Page 14: ...to form A minimum volume of 0 5 microliter is needed 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...

Page 15: ...strips safely in a disposable container Blood ketone test result Step 1 Unscrew the lancing device tip Step 2 Place the protective cover on the lancet Push the lancet ejector forward with the thumb to...

Page 16: ...Meter Memory The 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 Note...

Page 17: ...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...

Page 18: ...e meter and lancing device should be disinfected prior to use by the second person Pre cleaning and Disinfection Pre cleaning procedure is needed to clean dirt as well as blood and other body fluids o...

Page 19: ...tact the manufacturer or visit their website as listed above Name Manufacturer EPA registration number Active ingredients Clorox Healthcare Bleach Germicidal Wipes Clorox Professional Products Company...

Page 20: ...n the meter or lancing device When a part of the segment on the meter display does not flash When control solution test results do not fall within the stated range on the test strip box Caution Do not...

Page 21: ...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 Message The blood sample is o...

Page 22: ...ting a test strip The test does not start even after applying the blood sample on the test strip The test result does not match the way you feel General Troubleshooting Note If the problem is not reso...

Page 23: ...avg 3 4 mmol L CV 3 7 Blood avg 5 2 mmol L CV 3 5 Blood avg 6 9 mmol L CV 3 6 Precision Precision studies were performed in a laboratory using the KetoSens Brand of BKM Systems Between Run Precision C...

Page 24: ...ling tampering use or service of the meter Any claim must be made within the warranty period i SENS Inc will at its discretion repair or replace a defective meter or meter part that is covered by this...

Page 25: ...www i sens com 49 MEMO...

Page 26: ...50 www i sens com MEMO...

Page 27: ...being achieved ask a doctor to review management Reference Blood Ketone Measurement UHL Guideline 2013 Lo 0 5 mmol L Re test for blood ketones only if the blood glucose levels are higher than 120 mg...

Page 28: ...he back of this card for important information about ketone levels Keto Diet Ketone Blood Level Ranges May require medical attention Please check with your medical provider mmol L References http www...

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