Quality Control (Qc) - Bosch vivatmo pro Instructions For Use Manual

6.3

Quality control (QC)

External QC tests are used to control the measurements of the Vivatmo pro handheld in comparison to reference concentrations
of nitric oxide (NO). The system documents the tester who performs the QC tests by the user login.
QC is recommenended weekly or after 50 measurements if Vivatmo pro is used in a clinical environment. Commitment,
frequency and reference measurements to be performed are dependent on the local quality control standards of the operating
organization. The settings for the QC are done only by administrators, „6.5.2 Quality Control (QC) settings" on page 50.
Vivatmo pro supports QC for 2 reference concentrations:
Level 0
•
Level 0 is performed with a specific white Level 0 disposable mouthpiece, see page 15. A comparative test is performed for a
concentration below 5 ppb which is below the detection limit.
Defined NO with QC tester
•
The comparative test is performed by a qualified QC tester with a FeNO concentration below 55 ppb. For this test a
regular transparent disposable mouthpiece is used.
QC with defined NO is performed by users who have the QC tester qualification. A minimum of 1 individual needs to qualify,
2 are recommended, see below.
When QC for the Vivatmo pro is invalid or failed, the measurements are stored with the QC status
Instructions for use
QC !
1 8 PPB
07.04.2016 11:43
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Settings
in the patient data.
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