Symbols And Trademarks - Icare HOME2 Instruction Manual

17.7.2 Bench test results
Repeatability of iCare HOME2 tonometer was assessed in bench tests. The
tests were done by measuring a manometrically controlled artificial cornea.
The test pressures (7, 10, 20, 30, 40, and 50 mmHg) covered the specified
measurement range of iCare HOME2 tonometer. To assess repeatability, 10
measurements were performed with the iCare HOME2 tonometer at three
different measurement angles (the probe pointing at the artificial cornea at
0, 45, and 90 degrees to the horizontal).
iCare HOME2 tonometer demonstrated agreement with the true manometric
pressures, R-squared values being at least 99.7%, regardless of the angle of
measurement (0, 45 or 90 degrees). On average, the iCare HOME2 tonometer
underestimated the pressure by 0.04 mmHg with respect to the true
manometric pressures with standard deviation of 0.37 mmHg.
Reproducibility was assessed by a test in which two operators performed
three measurements with three different iCare HOME2 tonometers. Three
different pressure levels (7, 10, 20, 30, 40 and 50 mmHg) and three different
angles (0, 45, and 90 degrees) were used. The mean difference between
the operators was 0.14 mmHg with a standard deviation of 1.21 mmHg. The
R-squared value in regression analysis was 99.4%, which indicates high
reproducibility across the operators and the iCare HOME2 tonometers.
Please be advised that bench testing conditions do not cover all the error
sources within a clinical setting and thus higher variability is expected in
clinical use.
Due to the controlled test environment, the standard deviation of the bench
tests do not reflect the measurement variability that can be expected in
actual home use.
17.8

Symbols and trademarks

40
Caution
Consult
instructions for
use
Serial number
Single use
Do not re-use
Use by
Batch code
LOT number
Date of manufacture
Sterilized using
irradiation
Keep dry
Non-ionizing
electromagnetic
radiation