IMPORTANT: Please read the monograph, insert and the User Guide or Owner's Booklet that came with the system before using. The User Guide or Owner's Booklet has full instructions for blood glucose and control solution testing. Do Not use new test strips if the vial is open or damaged in any way. This could lead to error messages or inaccurate blood glucose results. The patient should contact Customer Service right away if he/she has questions about the test strips, test results or these instructions.
Limitations of Procedure: Use OneTouch Ultra Plus Test Strips under the following conditions to ensure accurate results: The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The OneTouch Ultra Plus Flex System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch Ultra Plus Flex System is not for use on critically ill patients, patients in shock, severely dehydrated patients or hyperosmolar patients (with or without ketosis).
Do Not use serum or plasma.
Haematocrit is the percentage of red blood cells in the blood. Extremes in haematocrit may affect test results. Haematocrit levels below 20% may cause false high readings. Haematocrit levels over 60% may cause false low readings. The patient should talk to the healthcare professional if he/she doesn't know his/her haematocrit level.
The OneTouch Ultra Plus Flex System is not recommended for alternate site testing (AST).
OneTouch Ultra Plus Test Strips should not be used at altitudes above 3048 metres as there may be an adverse effect on test results.
Interferences: Uric acid and other reducing substances (when occurring in blood at high normal or at high therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately low results.
CAUTION: The OneTouch Ultra Plus Flex Blood Glucose Monitoring System should not be used for patients within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results.
Do Not use the OneTouch Ultra Plus Family of Meters when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample.
Alternate Site Limitations: OneTouch Ultra Plus Family of Meters are not indicated for Alternate Site Testing (AST).