Battery Life
3 months of use, 3 tests per day
(Batteries near the end of their shelf
life will have reduced capacity.)
! Bad Test Criteria:
Slow start of test (Vext>5%) or a
cough detected in the rst second
FEV substituted for
FEV6
When FET < 3s and abrupt end of
test
Operating temperature
range
17 – 37°C
Operating humidity
range
30%–75%
Ambient pressure range 850hPa–1060hPa
Performance Standards:
ATS/ERS 2019, ISO 23747:2015, ISO
26782:2009
Safety standards EN60601-1, EN 60601-1-11
EMC Standards EN 60601-1-2
QA/GMP standards
EN ISO 13485, FDA 21 CFR 820,
CMDR SOR/98-282, JPAL, MDSAP.
Communications USB2.0/3.0
PC Requirements
Windows® 7, Windows® 8 or
Windows® 10
Auto power down time Set to 2 minutes as standard
13. Contraindications, Warnings, Precautions and
Adverse Reactions
1. No modication of this equipment is allowed. Any
unauthorised changes to the device may compromise product
safety and/or data and as such Vitalograph cannot be held
responsible and the device will no longer be supported.
2. The device should only be used under the supervision of a
healthcare professional.
3. The device is not designed as a sterile device. Always follow
the safety guidelines given by the manufacturer of cleaning
and disinfectant chemicals.
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