User's Manual

ETF-RD-BKQ-02. Instructions for Use (Rev.0)
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Important Information for the Test Strip
Important Information for the Control Solution
Limitation
• NEVER reuse a test strip that is either applied with blood or control solution. The test strips are for single
use only.
• Before using, please check the test strip expiration date on the box, vial or the foil packet.
• Do NOT use test strips that have expired as it may cause inaccurate test results.
• Do NOT touch sampling end of the test strip.
• Do NOT smear the blood with sampling end of the test strip.
• Do NOT drop the blood directly on the sampling end of the test strip.
• Do NOT insert the test strip with force into the meter.
• Do NOT use wet, bent, scratched or visibly damaged test strips.
• You should use your test strip immediately after retrieving it from its vial or foil packet.
• Always keep the test strip vial closed immediately after retrieving the test strip.
• Do NOT use the test strip if the foil packet has a puncture or tear in it.
• Use only the Medisign KT26 Ketone Control Solution. Other brands of control solutions will produce
inaccurate results.
• Shake the control solution well before using.
• Always check the expiration date of the control solution. Do NOT use expired control solution.
• Do NOT apply control solution to the test strip directly from the vial.
• Do NOT add or apply a second drop of blood or control solution. This may cause a false result.
• Replace the cap of the control solution immediately after use.
• If the control test result falls outside of the range provided, it indicates that the system may NOT be
functioning properly. Do NOT use the meter and please contact Customer Service.
• The range printed on the test strip vial or box is for the control solution only. It has nothing to do with your
blood β-ketone levels.
• The results obtained from control testing do NOT reflect your personal blood β-ketone levels in any way.
• This system is only for in vitro diagnostics use and for self-testing.
• This system is NOT designed for use with arterial, serum or plasma samples. You should use fresh capillary,
venous whole blood only.
• Do NOT put urine on the test strip.
• This system is NOT designed for use with neonatal.
• This system is NOT for screening or diagnosis of diabetes mellitus.
• Blood β-ketone testing must NOT use the forearm or palm site. Only use the fingertip for blood β-ketone
testing.
• Hematocrit is the percentage of red blood cells in the blood. Testing outside of the Hematocrit level range of
20~60% may cause inaccurate result. If you do NOT know your hematocrit level, consult with your
healthcare professional.
• Inaccurate results may occur if used at altitudes above 3,500m.
• This system is NOT for use on patients who are in shock or dehydrated.
• Inaccurate results may occur in severely hypotensive individuals.
• This system is NOT for use on critically ill patients.