III. Intended use
EOlife® is a medical device to help healthcare professionals perform pulmonary ventilation during cardiopulmonary
resuscitation and adapt their technique to comply with international guidelines from the AHA and ERC.
1. Target patients
EOlife® is indicated to treat adult patients at least 1 40 m in height who are in cardiopulmonary arrest It is also intended to be
used on a manikin or a patient simulator for training purposes
EOlife® can be used in and outside a hospital setting and when patients are transported in emergency vehicles It should only
be used by emergency professionals and healthcare professionals trained to perform CPR (basic life support)
2. Users
The EOlife® device must only be used by healthcare professionals and qualified first responders. It should not be used by
anyone who has not received training in BLS (basic life support) techniques
3. Indications for use
o Intended for emergency medicine in a hospital setting or at the scene of an emergency
o When transferring patients from one hospital to another in an emergency vehicle
o When transferring patients inside a hospital, for example between departments
EOlife® is intended for use in a home healthcare environment according to EN 60601-1-2
4. Contraindications
None currently known
5. Restrictions on use
EOlife® is not approved for the following uses:
o In a hyperbaric chamber
o Near magnetic resonance imaging machines
IV. Training of operators and users
EOlife® must only be used by people with training in BLS and some initial training in ventilation techniques
Operators and users must familiarise themselves with this device before using it by reading the instructions for use
When the device is delivered to a department by an ARCHEON staff member or approved distributor, training must be
provided in the handling and use of EOlife®
V. Safety
Precautions
o Before using the product, read these instructions carefully Failure to follow the instructions can lead to improper use
and expose the patient, user or persons nearby to risks
•
Use the device as intended (see "III. Intended use").
•
Comply with the restrictions on use (see "III. Intended use").
•
Carefully read the safety instructions in these instructions for use
•
Comply with all the sections in these instructions
o The use of defective devices could compromise the ventilation of the patient and impact their condition and may also
put the user at risk
•
Only use the EOlife® device and its accessories if they do not show any visible damage
o The EOlife® device, its battery, charger and the FlowSense® sensor must be stored and used as described in the
instructions for use (see "X. Technical data").
EN
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