Lab COVID-19 Trust Score
- Used by the UK and Indonesian governments
- Developed specifically in response to COVID-19
Certifications & Standards
- CE (Europe)
- ISO 13485
Key Advantages: Ventilator
- Pneumatic oxygen powered ventilator
- 2 ventilation modes: mandatory VCV and manual
- Suitable for adults and children over 10kg
- Airmix 100% or 50% Oxygen (100% Oxygen only version available)
- PEEP-Variable or Fixed
- Eliminates patient aerosol of contaminated exhaled gas
- No electrical power source required
- CE marked and ISO 13485 manufacturer
- Intubation/LMA device compatible
- Simple airway pressure indicator
- ZERO drive gas – this is the most efficient ventilation possible
Key Advantages: Patient Monitoring Including Alarms
- Comprehensive patient airway pressure monitoring with onboard airway pressure display
- Input gas supply status including pressure monitoring
- Patient airway pressure monitoring including real-time wave-form and breath confirmation
- Patient over-pressure, under-pressure and inspiratory effort
- Patient disconnect
- Power supply using USB power supply and integral battery backup
- Wi-Fi connection to remote monitoring station allows many patients to be monitored from a safe and un-contaminated area
- EN IEC 60601 and ISO 13485 compliant
A pneumatically powered ventilator suitable for use in emergency and short/medium term stabilisation periods for patients requiring respiratory support.
This is a proven pneumatic design that is coupled with a sophisticated patient breathing circuit that gives a high level of control in a very compact and affordable package.
Aerosol of contaminated patient expired gas is reduced to a minimum or eliminated entirely to control the risk of cross infection and re-infection of both patients and clinicians. The patient circuit includes an HME patient filter and a separate device filter.
Delivers 100% Oxygen or 50% concentration which uses 2/3rds less Oxygen. Example: Typical adult setting of 10 BPM @ 450 mls = 4.5 litres minute delivered volume using only 1.5 Litres of Oxygen.
PEEP valve included within patient delivery circuit with 0- 20 cm H2O variable or fixed versions available in 5 cm H2O steps (starts at 2.5).
The device does not use electrical or battery supply – no electricity needed at all.
Patient Monitor and Alarm Specifications
- Process of CE marking this device has started. The device ismanufactured by an ISO 13485 Certified company.
- Special derogation is required in each national regulatory region with respect to the alarm.
- Special dispensation will need to be sought from the FDA if used within the USA.
- Special dispensation may need to be sought from the relevant Authority in country of use.
Patient Monitor and Alarm Description
The patient monitor and alarm is a stand alone device that is designed to work with the Microvent ventilator. The input Oxygen supply to the ventilator passes through the monitor where the gas status is monitored. The patient’s airway pressure and status is monitored via an airway pressure monitoring line that is integral to the patient delivery circuit. The device is Powered using a USB charger with rechargeable internal battery backup recharged via the USB supply. The system includes the comprehensive ability to monitor a patient’s airway status and the input gas supply from a remote hub. The available system will allow for at least 50 patients to be monitored simultaneously.
Patient airway pressure status
The device monitors the patient’s airway pressure continuously and will sound an alarm accordingly.
- Patient over-pressure
- Patient under-pressure
- Patient disconnect
- Inspiratory effort
- Full wave form and individual breath confirmation
- PEEP confirmation
Input gas pressure status
The device monitors the gas pressure continuously and will sound an alarm accordingly:
- Supply failure
- Supply low – 2.8bar or less
- Supply high – 6.1bar or more
- Discontinue use – 9.8bar or higher
- Labels & Labeling (06 Apr 2020): Fix-A-Form helps to manufacture medical equipment