SD Biosensor SD Gluco Navii, Инструкция по эксплуатации и процедурам

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• Externally taken drugs L-dopa, dopamine, methyl-dopa, acetaminophen, and
ibuprofen will not interfere with SD GlucoNavii™ blood glucose results when taken at
therapeutic concentrations.
• Do not use SD GlucoNavii™ meter to test neonates or infants. It has not been
validated for neonatal or infant use.
• Always insert the test strip into the meter first, and then prick the finger.
SYSTEM SPECIFICATION
Meter Test Strip
ELECTROMAGNETIC COMPATIBILITY
This meter meets the electromagnetic immunity requirements as per ISO 15197 Annex
A. The chosen basis for electrostatic discharge immunity testing was basic standard
IEC 61000-4-2. In addition, it meets the electro -magnetic emissions requirements as
per IEC 61326. Its electromagnetic emission is thus low. Interference from other
electrically driven equipment is not to be anticipated.
PERFORMANCE CHARACTERISTICS:
The performance data for the SD GlucoNavii™ system (SD GlucoNavii™ meter with
SD GlucoNavii™ test strips) were obtained using capillary blood from diabetic patients
(method comparison, accuracy), venous blood (repeatability) and control solution (re-
producibility). Test results are “plasma-calibrated”. The reference values are obtained
using the YSI method. For method comparison, the results were compared with 6%
higher than the results obtained using YSI method. The SD GlucoNavii™ system
meets the EN ISO 15197:2003 requirements. The SD GlucoNavii™ system
performance has been evaluated both in laboratory and clinical tests.