R&D have confirmed that there is an issue with Spirotrac V Version 1.19 relating to the 1-page, FVC Post Test Report when VC Pre and Post Tests have been performed as part of the visit.
When the user performs Pre VC and Pre FVC tests followed by Post VC and Post FVC Tests and proceeds to print a 1-page report (set by configuration) the VC value on the report may be reported incorrectly. The VC value reported will be from the first VC Post Test performed and not the Best VC Post Test performed. This issue only occurs on the 1-Page Post report, the results displayed on-screen, on the Custom Reports and the Multi-page reports are correct.
Vitalograph are working on a fix for this issue but as a workaround the user can select the default Custom report or select the Multi-page report option.
Part Number affected:
70604/70704 (S/W Ref. 68674) – 7000 Spirotrac V (French)
70605/70705 (S/W Ref. 68675) – 7000 Spirotrac V (Spanish)
70606/70706 (S/W Ref. 68676) – 7000 Spirotrac V (Italian)
70607/70707 (S/W Ref. 68677) – 7000 Spirotrac V (Norwegian)
70608/70708 (S/W Ref. 68678) – 7000 Spirotrac V (Swedish)
70609/70709 (S/W Ref. 68679) – 7000 Spirotrac V (Dutch)
70612/70712 (S/W Ref. 68682) – 7000 Spirotrac V (Portuguese)
70615/70715 (S/W Ref. 68685) – 7000 Spirotrac V (Japanese)
Clinical risk / safety impact information and rationale for generation /non- generation of a FSN:
The potential reportability and potential for a Field Safety Notice (FSN) has been reviewed. An FSN is not required in this instance as the issue only occurs on the 1-page report in the instance of a VC+FVC Pre/Post visit, all values reported on screen and on all other reports are correct. Spirotrac V and spirometry in general is not intended to be used as the sole indicator for subject diagnosis.
Contact us if you require more information.
Page updated: March 15, 2022.