Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
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Page 47 of 78 DT_0006-15
4.3.1.2 ATS 5-breath dosimeter challenge testing
The challenge test procedure consists of multiple phases.
Baseline Phase: When the challenge session commences, the user may perform an
FVC session or select a previously performed FVC session for that subject. The best
accepted FEV
1
value from that session becomes the baseline value. It is not possible
to select/perform more than one baseline session.
Diluent Phase: The Diluent phase must be performed before the user can proceed to
the dosing phase. There is an option to perform a maximum of three diluent sessions.
A message displays after each blow to indicate the % fall from the baseline value.
When the best accepted FEV
1
value from this phase falls by >=20% from the baseline
value, the next phase offered to the user is the reversibility phase, i.e. no dosing
phases will be permitted.
Dosing Phase: A maximum of 5 dosing phases are possible. A message displays
after each blow to indicate the % fall from the best accepted FEV
1
value of the diluent
phase. If the fall is <20%, the software provides the option to proceed to the next
dose/session, otherwise the software calculates the PC20 and no further dosing
session(s) are permitted.
Reversibility Phase: The reversibility phase is optional and a maximum of three
reversibility sessions are possible. The user may exit out of the challenge series
without performing a reversibility test session. A message box displays after each test
to indicate the reversibility i.e. the FEV
1
value as a % of the Baseline.
4.3.1.3 ATS 2-min tidal breathing challenge testing
The challenge test procedure consists of multiple phases.
Baseline Phase: When the challenge session commences, the user may perform an
FVC session or select a previously performed FVC session for that subject. The best
accepted FEV
1
value from that session becomes the baseline value. It is not possible
to select/perform more than one baseline session.
Diluent Phase: The Diluent phase must be performed before the user can proceed to
the dosing phase. There is an option to perform a maximum of three diluent sessions.
A message displays after each blow to indicate the % fall from the baseline value.
When the best accepted FEV
1
value from this phase falls by >=20% from the baseline
value, the next phase offered to the user is the reversibility phase, i.e. no dosing
phases will be permitted.
Dosing Phase: A maximum of 10 dosing phases are possible. A message displays
after each blow to indicate the % fall from the best accepted FEV
1
value of the diluent
phase. If the fall is <20%, the software provides the option to proceed to the next
dose/session, otherwise the software calculates the PC20 and no further dosing
session(s) are permitted.
Reversibility Phase: The reversibility phase is optional and a maximum of three
reversibility sessions are possible. The user may exit out of the challenge series
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