Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
_______________________________________________________________________________________________________________
Page 46 of 78 DT_0006-15
On first use, the default values display for each Challenge Test and will be used
unless changed by the operator. Once changed, the new values become the
default.
5. The Challenge testing screen displays along with the Challenge test wizard
which guides the user through the Challenge test procedure.
4.3.1.1 Mannitol challenge testing
The user must read the Instructions on the wizard before proceeding. Once the
instructions are read the user should click the check box provided and click Next.
Pre Challenge Test Phase: The Challenge test procedure consists of multiple
phases. The pre challenge test phase is used to determine the baseline prior to the
issuing of a diluent or dose. In this phase the user should perform a spirometry test
with a minimum of two blows that meet repeatability criteria of 150 ml. The subjects
FEV
1
should be >=70% predicted. To determine the pre-challenge FEV
1
, select 'Start
Pre-Challenge Testing'. The FVC test screen opens. The user performs blows
(reference Spirometry Testing - FVC Test). On completion of the blows the user
selects the return button to exit the test screen and return to the challenge test wizard.
When the pre challenge testing results display, select Next to continue.
Dosing Step 1 of 9: Dosing stage 1 is used to determine the baseline FEV
1
. In the
first step the user is instructed to administer a dose to the subject as per the
instructions provided in the challenge test wizard. When the instructions have been
read and the dose administered, the user selects the Dose Administered button. This
will start the 60 second countdown timer.
On completion of the timer the FVC test screen opens and the subject must perform
two repeatable FEV
1
measurements. These measurements must be within 0.15L
(150ml) variability. If there is greater than 0.15L variability between readings, the
subject will be instructed to perform another FEV
1
. The highest FEV
1
reading is
recorded as the baseline FEV
1
. If the highest FEV
1
is >=10% drop from the pre-
challenge FEV
1
the challenge test should be discontinued. To exit the FVC test screen
press the return button. The results of the Dose Step 1 Phase will be displayed.
Select Next to proceed to the next and subsequent phase(s). Administer the dose for
the current phase as per the dose instructions. Select the Dose Administered button.
Perform repeatable FEV
1
manoeuvres as per the guidelines provided and exit the test
screen to move to the next phase.
Challenge Outcomes: When a subject achieves a fall in FEV
1
of 10% or greater
between dose phases or a 15% fall from the baseline FEV
1
a positive result is
achieved. The Challenge test procedure is completed and the user has the option to
perform a recovery phase.
Recovery Phase: Administer a bronchodilator and monitor the subject for 15 minutes
to ensure their FEV
1
has returned to within 5% of pre-challenge level. In the case of a
negative result you may or may not wish to give a bronchodilator.
To Next Page
Loading...
Need help?
General
