Intended Use; Target Patients; Users; Indications For Use - ARCHEON EOlife Instructions D'utilisation

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
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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")
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o We advise carrying the EOlife® device in its carrying-case or kit-bag when included in a first aid bag (see "VII Equipment
and accessories")
o The device can be safely used outdoors, as it is rainproof, splashproof and cannot be penetrated by solid objects larger
than 1 mm (IP44 rating) However, it should be handled with care and kept away from powerful water jets and dust
o Always check the battery level before using EOlife® We advise recharging the battery after each use Change the battery
if the charge is below 20% We also advise having a spare operational battery in case this is needed
o Using a battery with a low charge at temperatures below 0°C greatly reduces the run time and can cause EOlife® to stop
functioning after a short time If the device is used at low temperatures, the battery should be fully charged
o Do not remove the battery when EOlife® is switched on
Warnings
Avoid using EOlife® next to or in combination with other devices as this could cause it to malfunction If devices must
be used next to each other or together, monitor both devices to check that they are functioning properly
Using the device in a way other than as described by ARCHEON and using non-approved accessories could affect the
patient's ventilation and health
To ensure that EOlife® functions effectively you must follow the instructions provided by ARCHEON
Never use the EOlife® device or its accessories in a hyperbaric chamber as this could cause an explosion Never use the
EOlife® device or its accessories in a hyperbaric chamber
Any technical alterations to the device could affect the patient's ventilation and health
•
No alterations should be made to the device or its accessories
The use of accessories, transducers and cables other than those specified or supplied could increase the
electromagnetic emissions or decrease the electromagnetic immunity of the device and cause it to malfunction
Portable high frequency communication devices (e g wireless devices, antennas and their cables) in close proximity
to EOlife® can interfere with the device and reduce its performance Keep EOlife® at least 30 cm from portable high
frequency communication devices
Handling the battery improperly could seriously injure the patient, user and persons nearby The battery must not
be disposed of in a fire, opened, deformed or short-circuited The battery must be protected from humidity, high
temperatures and high pressure (see "X Technical data")
The FlowSense® flow sensor is for single use only It must be used as soon as it is removed from its packaging
and discarded after use Re-using or decontaminating single-use items could contaminate the patient or have
unforeseeable life-threatening consequences It is advisable to always carry a spare FlowSense® sensor
If you notice any malfunction or damage to the product or packaging, do not use EOlife® or the FlowSense® sensor
and return them to the manufacturer or distributor
Always clean the EOlife® electronic unit after use as instructed in "IX 3 b) Cleaning EOlife® and its accessories"
The EOlife® electronic unit, the FlowSense® sensor, the battery and the charger must be discarded at the end of their
lifetime as instructed in "IX 3 d) Disposal"
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