Philips Respironics E30 User Manual page 3

Emergency Use Authorization
The Philips Respironics E30 Ventilator is provided globally for use under local emergency use
authorizations, such as the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for
ventilators, Health Canada Interim Order for use in relation to COVID-19, and waiver of CE marking, which
authorize its use for the duration of the COVID-19 public health emergency, unless terminated or revoked
(after which the products may no longer be used).
Read Before Using
If device is to be used invasively, at minimum, a rigorous external monitoring system needs to be in place,
including all of the functionality and alarms that are required for monitoring critically ill and mechanically
ventilated patients.
The Philips Respironics E30 device is compatible with all DreamStation oximetry capable accessory
modules. See the DreamStation Oximetry Installation and Operation Guide for more information.
Please refer to all warnings in the Introduction of this manual. Below are critical warnings that the
healthcare provider should be aware of.
Warnings
Device usage
The Philips Respironics E30 ventilator is a multi-patient use device, but should only be used on a single
patient at any given time.
Patient monitoring
Prior to placing a patient on the ventilator, a clinical assessment should be performed to determine:
• The device alarm settings
• Needed alternative ventilation equipment
• If an alternative monitor (i.e. an alarming Pulse Oximeter or Respiratory Monitor) should be used
Alternative Ventilation
For ventilator dependent patients, always have alternate ventilation equipment, such as a back-up ventilator,
manual resuscitator, or similar device available. Ventilator dependent patients should be continuously
monitored by qualified personnel. These personnel should be prepared to provide alternate therapy in the
event of ventilator failure or inoperative equipment.
Oxygen
When using supplemental oxygen with this system, turn the device on before turning on the oxygen. Turn the
oxygen off before turning the device off. This will prevent oxygen accumulation in the device. Explanation of
the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the
tubing may accumulate within the device's enclosure. Oxygen accumulated in the device enclosure will create
a risk of fire.