Appendix: B FAA Compliance 139
Doc. 007232 Y-2
Vivo 3 Clinician
’
s Manual
B
FAA Compliance
To whom it may concern:
The US Department of Transportation (DOT) Final Rule,
“
Nondiscrimination on the
Basis of Disability in Air Travel
”
(73 FR 27614 which updates Title 14 CFR Part 382),
effective May 13, 2009 provides important requirements for the accommodation of pas-
sengers with respiratory assistive devices (Ventilators, Respirators and CPAP machines).
In line with these requirements, respiratory assistive devices may be used onboard an
aircraft, without further testing by the carrier, provided they have been tested for Elec-
tromagnetic Compatibility (EMC) in accordance with the current version of RTCA/
DO-160, Section 21, Category M.
Breas Medical has successfully completed testing for the ventilator System. The ventila-
tor System complies with RTCA/DO-160, Section 21, Category M and can be consid-
ered FAA compliant.
Some airlines may require advance notification before travel, and devices may need to
be operated by battery. Breas Medical recommends that customers check with their
airline.
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