Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
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Page 43 of 78 DT_0006-15
Message displayed Reason
FEV
1
is not repeatable
The largest FEV
1
and the second largest FEV
1
from the acceptable
blows in the current session vary by more than 0.15L.
4.1.9 System Acceptability
A 'Usable' curve is any curve which passes the 'Start of Test' acceptability criteria and
which is artefact free, i.e. no cough detected by system. The 'System Defined
Usable/Acceptable' results are as follows:
indicates a curve which passed all test acceptability criteria.
indicates a curve which passed 'Start of Test' and 'Artefact free' acceptability
criteria only.
indicates a curve which did not pass both the 'Start of Test' and 'Artefact free'
acceptability criteria.
Note: If the user rejects a curve then that curve is no longer considered as a usable
curve.
4.1.10 Best Test Criteria
All tests in a test session will be saved (including unacceptable tests).
The best test criteria are:
• The highest volume parameters from acceptable tests. All other parameters
shall be taken from the acceptable test with the largest FVC+FEV
1
sum.
Rejected tests will be used if there are no usable tests.
When performing a Post-test session, the best pre-test is associated with the Post-test
session.
4.1.11 Session Grades
Each test series can be graded in relation to its reproducibility between system
usable/acceptable manoeuvres. Grades are displayed in the session information tab.
Grades are calculated based on the type of blow achieved:
1. Usable Blow – A blow that meets start of test criteria and does not contain a
cough artefact.
2. Acceptable Blow - A blow that meets start of test and end of test criteria.
Quality Grade Criteria
A
At least 3 acceptable blows with the largest 2 FEV
1
values within 150mL
and largest 2 FVC values within 150mL
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