Instructions for Use Evone
8
Use of Evone close to other equipment, stacked with other equipment or covered with other
materials should be avoided because it could result in improper operation. If such use is
necessary, all equipment should be observed to verify normal operation.
Do not use Evone in combination with humidifiers or nebulizers. This creates a risk on
blocked filters and insufficient ventilation.
Before using Evone, make sure prescribed maintenance (section 8) has been performed.
Otherwise, there is a risk on malfunction or no ventilation.
Evone may not be modified, (partly) dissembled or opened at any time. This creates a risk
on malfunction.
Regularly check EtCO
2
while ventilating with low inspiratory volumes. Rebreathing can occur.
This creates a risk on insufficient ventilation.
Make sure alarm limits are appropriate for the patient and actual situation. Otherwise, there
is a risk on harming the patient, which can occur since the range of alarm limit settings is
broad.
In Jet Mode intratracheal pressures measured may be slightly underestimated as compared
to actual pressure due to the venturi effect. This creates a risk of too high airway pressures.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
To set alarm limits towards extreme values may render the alarm system useless.
Do not obstruct exhaust openings on the back side of Evone.
The operator shall not touch serial port or CO
2
sensor port simultaneously with the patient.
Table 1.1 List of applicable warnings
1.8 Generic cautions
Cautions
The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
The internal dead volume of Evone, excluding endotracheal tube, is 42 mL when using the
Evone Breathing Tubing and 52 mL when using the Evone conventional tube adapter, which
may influence ventilation efficiency for patients with a low respiratory volume.
Evone is designed conforming the IEC 60601-1-2 EMC standard but non-conforming equipment
can either be influenced by or may influence Evone.
The achievable minute volume of Evone can be not higher than 9 L/min – depending on
patient characteristics - which should be taken into account for clinical situations that
usually require higher minute volumes.