User's Manual

ETF-RD-BKQ-02. Instructions for Use (Rev.0)
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Intended Use
The Medisign KT26 BT blood β-ketone monitoring system is intended to be used for the quantitative measurement
of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood samples from the fingertips. Venous whole
blood testing is limited to healthcare professionals use only. It is intended for self-testing outside of the body (in
vitro diagnostic use only) by people with diabetes at home and healthcare professionals in a clinical setting as an
aid to monitor the diabetes control. This system is NOT for use in diagnosis of or screening for diabetes, or for
neonatal use.
Test Principle
β-Ketone in the blood sample reacts with enzyme (beta-hydroxybutyrate dehydrogenase) on the test strip
respectively. This reaction produces a harmless current and the Medisign KT26 BT blood β-ketone meter measures
the current, and calculates the β-ketone level and displays the result. The strength of the current is dependent on
the amount of β-ketone in the blood sample.
Important Information for the System
• Before using the Medisign KT26 BT blood β-ketone monitoring system, please read this manual carefully.
• Use this system only for blood β-ketone test.
• The Medisign KT26 BT blood β-ketone meter should be used with the Medisign KT26 blood β-ketone test
strips.
• If your test result does NOT match how you feel, call your physician or healthcare professional.
• NEVER ignore symptoms of high blood β-ketone.
• If you see “HI” displayed, your blood β-ketone level may be above 8.0 mmol/L, repeat the blood β-ketone
test using a new test strip. If the meter persists same results, contact your physician or healthcare professional.
• This system could support your healthcare program but NEVER make major changes in your diabetes
treatment program without consulting your physician.
• The results of this system should NOT be used for diabetic treatment or medications without consulting your
doctor.
• Be sure to check the blood β-ketone measurement unit on the meter before the test. Use of the wrong blood
β-ketone measurement unit may cause you to misinterpret the test results and result in incorrect treatment.
Consult your healthcare professional if you have any questions about your blood β-ketone measurement
units.
• Before the test you must make sure that the code number displayed on the meter matches the code number
on the test strip vial or foil packet.
• If alcohol wipes are used to disinfect the fingertip, make sure the fingertip is completely dry before obtaining
the blood sample.
• Before sampling blood, gently massage the hand and finger toward the puncture site to form a drop of blood.
Do NOT squeeze excessively around the puncture site when you produce a drop of blood.
• Do NOT hold or shake the meter while it is testing.