NDD easyone pro User Manual

EasyOne Pro™ / EasyOne Pro™ LAB 109
Hygiene, Cleaning, Maintenance, Disposal
Detailed Description
FEV1, FVC and FEV6 are the spirometry parameters used for BioCal-Check
quality control. The software will establish a baseline mean value (precision
range) for each BioCal Subject and sensor from trials repeated daily for 20
days. This baseline will then be used to trend all subsequent BioCal-Check
sessions for the BioCal Subject and sensor. Immediate quality feedback will
be provided by the software in accordance with the BioCal-Check QC grades
alerting the user of quality warning conditions for the parameters collected.
The BioCal-Check data will be plotted against time. The BioCal-Check refer-
ence lines will be mean (precision range), upper limit and lower limit. The
upper and lower limits are +/- 2 SD (Standard Deviation).
Specifications of the BioCal-Check QC Grades
For each parameter (FEV1, FVC, FEV6, DLCO, VI, VA) an individual BioCal-
Check QC grade is calculated. Additionally the lowest grade of all parame-
ters is reported.
Disposal
The product described in this operator manual must not be disposed as
unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information concern-
ing the decommissioning of your equipment.
Bio-QC
Grade
Limitation Additional Limitation
BA --
BB 1 value outside ±2SD -
BC 1 value outside ±3SD -
BD
>= 4 values outside ±1SD only consecutive values on
same side of mean
>= 2 values outside ±2SD only consecutive values on
same side of mean
> 1 value outside ±3SD -
>= 10 values, consecutive
values on same side of
mean
-
BF < 20 baseline values -

NDD easyone pro Specifications

General

Brand	NDD
Model	easyone pro
Category	Medical Equipment
Language	English