Warnings/Precautions - SEFAM nea Patient Manual

M-170DFU00-20 - V7 - Mise en activité le 01/08/2024

Warnings/Precautions

WARNING:
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Use this device only with the authorized accessories listed in this manual.
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Use the device only for the purpose recommended in this manual.
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Néa may only be used on medical prescription.
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The device is not intended to provide assistance with vital functions.
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To ensure proper maintenance, and to avoid all possible damages, only qualified and trained personnel is
authorized to perform maintenance work or authorized modifications on the device. The user takes full
responsibilities for any dysfunction of the device caused by any maintenance done by any unauthorized
person.
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Do not begin treatment if you detect an anomaly with the device.
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Never use the device before making sure that the air inlet filter is installed.
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Place the device on a stable horizontal surface in a clean, dry environment. Do not use the device if it is
adjacent to or placed on top of another device.
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Do not accidentally or intentionally obstruct the air outlet or any opening in the device or breathing circuit. Do
not cover the device or place it too close to a wall. Do not introduce liquids or objects into the air outlet, as
they could be propelled into the tube.
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Keep the device and its power supply module away from all sources of water. Only use the device and its
accessories if they are dry and in working order.
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Keep the power cord away from any hot surface.
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If additional oxygen is required, scrupulously comply with the instructions and safety instructions relating to
the use of oxygen.
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Do not use the device in the presence of flammable vapours and in particular the heated humidifier 'Néa H2O'
in the presence of flammable anaesthetic products, either independently or mixed with other gases (risk of
explosion).
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Do not leave unnecessary lengths of tube on the bed. They could wrap around your head or neck when you
sleep.
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Keep the device away from children and pets.
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Once the device is operating and the mask is in place, check that the device is producing an airflow. If not,
remove the mask immediately.
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Never obstruct the mask's exhaust port, which allows air to escape continuously and minimises the
rebreathing of carbon dioxide. If the device is operating, the air produced will force the exhaled air through
the mask's leak hole. However, if it is not working, there will not be enough fresh air produced in the mask
and exhaled air may be rebreathed, which could lead to suffocation in certain circumstances.
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If the device malfunctions and the patient is fitted with a nasal mask, the resistance of the device is low
enough to allow the patient to breathe out through the device or simply open his mouth. If the patient is fitted
with a face mask, the mask must have an anti-asphyxia valve device.
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Remove the mask in the event of a power cut or device malfunction.
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Any serious incident that occurs in relation to use of the Néa must be communicated to the manufacturer
and the competent authority for the Member State in which the user and/or patient is located.
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As this device is an electrical medical device, during its installation, please follow and respect all instructions
concerning the electromagnetic compatibility, as indicated in this manual. It must not be used outside its
intended electromagnetic environment. Furthermore, the Néa device must not be used if the housing or the
cables are damaged.
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It is advisable not to use portable RF communicating devices (including peripherals, such as antenna cables
as well as external antennas) closer than 30 cm (12 inches) from all parts of the Néa device. This also
includes the specified cables by the manufacturer. Should the opposite happen, the performance of these
devices could be altered.
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The equipment must not be covered or positioned in such a way that the operation or performance of the
equipment is adversely affected.
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Equipment apnoea (Aflow); equipment hypopnoea (Hflow); and equipment apnoea hypopnoea index
(AHLflow) are an estimate provided by sleep apnoea breathing therapy equipment and not diagnostic
parameters.
Néa
Manuel patient NEA Anglais
It means that there is a possibility of danger risk of injuries or accident to yourself
or others.
Product description ▪ 5
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