Advanced Instruments Osmo1 User Guide

Appendix B Performance characteristics
62
Osmo1® Single-Sample Micro-Osmometer User Guide
The average osmolality results of the three 3320 osmometers were compared to each of the Osmo1 osmometers using
the Passing Bablok regression analysis method. All results met acceptance criteria and did not exhibit any statistically
significant proportional or constant biases as the 95% confidence interval of the slope and intercept encompassed 1.0
and 0.0 respectively as shown in the results table below.
Passing-Bablok Regression Analysis Results
Intercept Slope
Lower 95%
CI
Estimate Upper 95%
CI
Lower 95%
CI
Estimate Upper 95%
CI
Osmo1 #1 -2.388 -1.000 0.232 0.997 1.000 1.003
Osmo1 #2 -1.186 -0.112 0.675 0.999 1.001 1.004
Osmo1 #3 -0.667 -0.189 0.591 0.996 0.998 1.000
Within-Run Repeatability
1
(AI standards and reference solutions)
Standard deviation ≤2 mOsm/kg H
2
O between 0 and 400 mOsm/kg H
2
O
Coecient of variation ≤0.5% between 400 and less than 1500 mOsm/kg H
2
O
Coecient of variation ≤1% from 1500 to 2000 mOsm/kg H
2
O
Temperature Eects
Less than 1 mOsm/kg H
2
O for every 5 °C (9 °F) ambient temperature change
Operating Conditions: Temperature 18 °C to 35 °C (64 °F to 95 °F); 30 to 80 % relative humidity (non-condensing).

Advanced Instruments Osmo1 Specifications

General

Brand	Advanced Instruments
Model	Osmo1
Category	Medical Equipment
Language	English