Vivo 45 LS

The Vivo 45 LS is a portable, microprocessor-controlled ventilator for continuous or intermittent ventilatory support in pediatric and adult patients weighing over 5 kg. It operates in multiple pressure-support, pressure-control, and volume-control modes for both invasive and non-invasive ventilation in home, institutional, and portable settings. Optional SpO2 and CO2 sensors measure blood oxygen saturation and respiratory gas levels.

The subject device adds four new features to the predicate Vivo 45 LS (K193586): High Flow Nasal Therapy (HFNT) with user-controlled flow rates up to 60 L/min; alarm pre-silence capability via a 3-second button hold; integrated heated humidifier with temperature control (16–30°C) and click-in water chamber; heated wire patient circuit with embedded spiraled heating wire and patient-end temperature sensor. Supplemental oxygen bleed rate increased from 15 to 30 L/min. All other mechanical, electronic, and software elements remain unchanged.

ANSI/AAMI ES60601-1:2005 (electrical safety); IEC 60601-1-2:2014 (EMC); IEC 60601-1-6:2010+A1:2013 (usability); IEC 60601-1-8:2006+Am1:2012 (alarm systems); IEC 60601-1-11:2015 (home healthcare); ISO 80601-2-12:2020 (critical care ventilators); ISO 80601-2-55:2018 (respiratory gas monitors); ISO 80601-2-61:2017 (pulse oximetry); ISO 80601-2-72:2015 (home healthcare ventilators); ISO 80601-2-74:2017 (humidifiers); ISO 18562-1,2,3:2017 and ISO 10993 series (biocompatibility).

The subject device shares the same core mechanical design, turbine-based gas delivery system, and intended use as the predicate Vivo 45 LS. New features (HFNT, humidifier, heated circuit, pre-silence alarm) are analogous to functions in legally-marketed reference devices (Newport HTS50, Fisher & Paykel MR810 and myAIRVO 2) or are software extensions of existing controls. Performance testing demonstrates the device meets all accuracy and specification requirements identical to the predicate, and summative human factors testing with 45 users (respiratory therapists, nurses, lay caregivers) confirmed safe and effective use with no new hazards. Biocompatibility testing of the humidified pathway shows non-toxic emissions and extractables.