Chapter 14 Revision History
000191-16 NIOX VERO
®
User Manual English 43
14 Revision History
Revision Changes
02 Initial release
03 Corrected typographical errors. /Added Windows 8.1 in requirements
/ NIOX® Panel connectivity module information added / Firmware
Update added / Added symbol for NRTL / Modified Precision
information / Added reference to NIOX® Patient
04 Added reference to PC user manual and symbol for prescription use
05 Added explanatory notes / Image updates/Added explanation of
cloud icon / Added to statement on deciding at a later stage to allow
data collection /Added “Changing contact details” /Changed
reference to NIOX® Patient to NIOX® Apps
06 Updated system requirements and removed notes from 6.2 and 6.7.1
07 Added note on storing patient filters / Updated firmware version
reference / Added reference to alert code A42 / Updated shelf life of
patient filter to 3 years /Added section for “Essential Performance”
08 Changed Aerocrine to Circassia and modified information on patents
/ Changed web address from Aerocrine to NIOX®.
09 Changed “customer support” to “technical support” / Added
clarification to the statement on the number of measurements that
can be performed / Added warnings related to the use of alcohol /
Changed responsible manufacturer address within Sweden / Moved
and expanded warning related to use of alcohol / Added a bullet
concerning replacing sensor or batteries while the device is in
operation / Added a statement concerning used patient filters /
Modified the bullet concerning the maximum number of exhalations.
10 Addition of nasal nitric oxide: Intended Use modified / Added
“Activate Nasal measurement mode”/ Added “Perform Nasal
measurements”
11 Clarified point on instrument operational life / Added NIOX® Panel
CE marking /Added statement on NIOX® Panel SW / Updated
firmware revision reference/ Updated phone number on cover
12 Updated firmware revision referenced / Modified note in 6.6 / Added
symbol for manufacturing date
13 Updated firmware revision referenced
14 MDR updates: Modified the warning for Patient Filter reuse /
Updated text describing disposal of electronic waste and added an
alternative symbol / Added MD symbol / Created table for transport
and storage conditions and removed initial transport conditions/
Removed note on Filters / In vigilance section, changed reporting
days from 30 to 10/15 and added a statement about reporting to
Circassia and the competent authority
15 Moved warning to warnings section / Remove software version from
1.2 / Minor updates to the intended use statement / Add section 1.7
Principals of Operation / Removed the word “caution” from 5.3.3 /
Turn QC functionality on or off section, clarified / Added for
Information Security / Changed R&TTE Directive to RED Directive /
Revision History added / Removed TK 1000 (obsoleted)
16 Added Windows 11 as system requirement in section 6.1
To Next Page
