In response to COVID-19, the SAVe II underwent performance modifications to maximize efficiency. The SAVe II+ is authorized for emergency use in healthcare settings, subject to the conditions set forth in a US Food and Drug Administration Emergency Use Authorization (EUA) 200336.
The SAVe II+ is intended to provide ventilatory support for adults during CPR or when positive-pressure ventilation (PPV) is required to manage acute respiratory failure (ARF), or other situations where mechanical ventilation is needed. The SAVe II+ series is appropriate for adults that weigh at least 45 kg (99lbs). It is intended to be used in pre-hospital settings, field hospitals, outpatient environments, hospitals, ICU’s, transport environments or any other healthcare setting requiring the use of a ventilator.
The SAVe II+ uses a battery-powered compressor to deliver air to a patient for up to 8.5 hours on a single charge. To support use in austere or supply constrained environments, where compressed oxygen is unavailable or ill advised, the device does not require compressed oxygen. However, FiO2 can be increased from 21% to 100% if compressed oxygen or an oxygen concentrator is available.
SAVe II+ ENHANCED FEATURES:
- Increased maximum minute volume from 8LPM to 12LPM
- PEEP increased to 20 cmH2O. (Up from a previous maximum of 10 cmH20)
- HME Filter and Exhale Bacterial Filter compatible
- Simplified Quick Start Guide
FEATURES OF ALL SAVe II SERIES PRODUCTS:
- Height-based adult presets enable rapid setup
- Presets dial in lung-protective ARDSnet-based parameters (~6 ml/kg) based on ideal body weight
- Small size and weight make it one of the most portable ventilators on the market
- Adjustable tidal volume (TV), respiratory rate (RR), peak inspiratory pressure (PIP) and positive end expiratory pressure (PEEP)
- Alarm dashboard and integrated quick reference chart simplifies troubleshooting
- No compressed gas required
- Delivers FiO2 up to 100% using included oxygen reservoir and user provided flow regulated oxygen source.
- Displays breath-to-breath PEEP and PIP measurements
In accordance with Emergency Use Authorization 200336 from the FDA:
i. The SAVeII+ ventilator has not been FDA cleared or approved;
ii. The SAVeII+ ventilator has been authorized by FDA under an EUA;
iii. The SAVeII+ ventilator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency
use of ventilators under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),unless the authorization is terminated or revoked sooner