Spirit i-SENS TEE2, Руководство владельца

Страница: 5 / 34

4
www.i-sens.com www.spirit-healthcare.co.uk
5
Downloaded from www.Manualslib.com manuals search engine
Important Information: Read this First!
To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note the
following instructions:
The following chart explains the symbols you’ll find in the
TEE2 Owner’s Booklet, product packaging, and product inserts.
For in vitro diagnostic use
This product fulfills the requirements for Directive 98/79/
EC on in vitro diagnostic medical devices
Cautions for safety and optimum product use
Consult instruction for use
Do not discard this product with other household-type
waste
Use by (unopened or opened test strip vial)
Manufacturer
Temperature limitations
Do not reuse Batch code
Serial number Authorised representative
Important Information
• The TEE2 Blood Glucose Monitoring System is intended for
self-testing outside the body (in vitro diagnostic use).
• The glucose in the blood sample mixes with special
chemicals on the test strip to produce a small electrical
current. The TEE2 meter detects this electrical current and
measures the amount of glucose in the blood sample.
• The TEE2 Blood Glucose Meter is designed to minimise
code related errors in monitoring by using the no-coding
function.
• The TEE2 Blood Glucose Meter should be used only with the
TEE2 Strip.
• An abnormally high or low red blood cell count (hematocrit
level over 60% or below 20%) may produce inaccurate
results.
• If your test result is below 3.3 mmol/L or above 13.3 mmol/L,
consult a healthcare professional immediately.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycaemic-
hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
If you need assistance, please contact the Spirit Healthcare 24/7
Freephone Support Line at 0800 881 5423 or go to
www.spirit-healthcare.co.uk.
Intended use:
TEE2 Blood Glucose Monitoring System is used for the
quantitative measurement of the glucose level in capillary whole
blood as an aid in monitoring diabetes management effectively
at home or in clinical settings.
TEE2 Blood Glucose Monitoring System should be used only for
self-testing outside the body (in vitro diagnostic use only). A TEE2
Blood Glucose Monitoring System should not be used for the
diagnosis of diabetes or for testing newborns. Testing sites
include the traditional fingertip testing along with alternate sites
testing on forearm, palm, thigh and calf.