Engineered beyond the COVID-19 pandemic

Pantheon Emergency Ventilator™ (PEV™)
Made in Canada

The PEV™ continuously delivers pressure-controlled ventilation through several modes (CMV-PC, A/C-PC) using a turbine-based design and can be used for invasive and non-invasive ventilation. 

In addition, the PEV™ does not require medical compressed air to function and can be supplemented with external oxygen sources to deliver higher oxygen content, which makes the PEV™ an ideal device for makeshift hospitals in addition to regular hospital settings. PEV™ is certified by Health Canada under the Interim Order authorization as a Class 3 medical device.

INQUIRE

Ventilation modes:

CMV-PC (Continuous Mandatory Ventilation with Pressure Control)

A/C-P/C (Assist/Control Ventilation with Pressure Control)

Dimensions:

Weight: 27kg

Dimensions (L x D x H): 78 cm x 42 cm x 55 cm  

Power:

Main power supply: Medical grade (2MOPP – IEC 60601-1)

Power cable: Hospital grade locking C13 connector (UL 817, CSA C22.2 no. 21, UL 498, and UL 60601-1)

Alarms:

Wide range of alarm and failsafe settings, including high and low expiration and inspiration pressure, High/Low PEEP, High/Low PIP, loss of power, and patient circuit disconnect alarm. 

Critical alarms cannot be disabled to minimize human error. 

Bootup diagnostics to ensure alarms are functional.

Visual (light) and audio alarms as redundancy measures. The screen also indicates to the user that an alarm is triggered. 

Backup power:

Backup battery lasts 3 hours to allow patient to be moved within the hospital.

Turbine rated for 50,000 hours or 2,100 days of continuous use.

Stainless steel 304 parts that are CNC machined to withstand high usage.

Steel casing protects parts from damages when moved.

1 year manufacturer’s warranty.

The adaptable, intuitive platform of the PEV™ was first based off the UK MHRA guidelines to emergency ventilators. Ocalink then received input from respiratory therapists, intensive care physicians, biomedical engineers, and other clinicians at Vancouver Coastal Health and Fraser Health Authorities to ensure the device is suitable for end users.

After the initial design and consultation process, the PEV™ underwent usability testing by Alberta Health Services at the Foothills Medical Centre at the University of Calgary using the ASL 5000 lung simulator.

Additional alarms were added based on comments from Alberta Health Services.

The PEV™ is certified by Health Canada under the Interim Order authorization (Manufacturer ID 153426 and Device ID 1024413).

The PEV™ passed the Electromagnetic Compatibility (EMC)  testing as well as SPE-3000  medical electrical equipment and medical electrical systems standards prescribed by Health Canada:

EMC Emissions Full Pre-Scan Test encompasses emission standards in IEC 60601-1-2:2014 Edition 4.0, ISO 80601-2-12:2020-02, CISPR 11:2009+A1:2010.

SPE-3000 Field Evaluation of Medical Electrical Equipment and Systems Test encompasses compliance to IEC 61032:1997, IEC 60417-DB-12M-2002, IEC 62353-2014, ISO 7000-2012, ISO 7010-2011

The PEV™ is under review by the U.S. FDA

ISO 13485 medical device contract manufacturers ensure full traceability as required by Health Canada under normal manufacturing standards for medical devices. 

Parts and components of the PEV™ are supplied by ISO 9001 producers to ensure they are manufactured under high quality control and quality management systems.

why choose ocalink

Large quantities available now

We can deliver large production quantities. 

We have designed the PEV™ with the constrained and disrupted global supply chain in mind—we picked parts that can be easily sourced or machined within Canada, and therefore we can easily scale up our production capacity even under pandemic conditions.

Working with multiple ISO 13485 manufacturers allows us to meet surges in production demand.

1,000 units per day in capacity

We can scale up our capacity to producing 1,000 devices per day with the ISO 13485 contract manufacturers we have under manufacturing and supply agreement. We can scale higher with additional manufacturers globally.

Easy to store and stockpile

The PEV™ can be stockpiled in large quantities because of its box-shaped design. A 300 sqft (28 m²) room can hold hundreds of PEV™ versus a much reduced amount for stand-up ventilator designs.

ISO 13485 manufacturing quality

ISO 13485 manufacturing means quality and full traceability for each component. It also means reasonable certainty of delivery because of the collective experience that are inherent in ISO 13485 manufacturers.

Maintenance & technical support

The PEV™ is easy to self-maintain by existing hospital staff, and mostly only requires cleaning instead of servicing by the manufacturer. In addition, we do provide customer care and technical support.