SEFAM nea Patient Manual page 6

M-170DFU00-20 - V7 - Mise en activité le 01/08/2024
In case the device is equipped with a heated humidifier 'Néa H2O':
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The side cover must be removed and replaced by the humidifier that includes the hot plate and tank.
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Precaution must be taken by the patient while using the tank in order to prevent any risk of water entering
the device, which can cause irreversible damage. For this purpose, the device must be placed on a horizontal
and stable surface, and not in a tilted position.
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Do not add any product to the water in the tank (essential oils, etc.) as they may have adverse effects.
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The tank should always be emptied before moving it with the device or transporting it.
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The humidifier must not be used with nitric oxide. This could cause the humidifier to malfunction, leading to
a serious deterioration in health.
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The use of a humidifier with a gas source (for example, a fan equipped with a compressor/turbine) that heats
the gas supplied to the humidifier above a temperature of 35°C may lead to an alteration in the amount of
humidification delivered, potentially causing serious deterioration in health.
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The heated humidifier has a plate that may be hot during normal operation, as may the bottom of the tank.
Avoid touching them.
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The tank must be cleaned before using it for the first time or after any technical intervention, and then
regularly as described in the "Cleaning and Maintenance" paragraph.
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Fill the tank bottom of 'Néa H2O' with water away from the device to prevent water dripping onto it.
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Do not use the device if you notice any leaks from the tank, e.g. due to damage to the seal.
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The heated humidifier must not be used at an ambient temperature above 35°C, as the temperature of the
air delivered to the patient could exceed 43°C. This could lead to irritation or burns of the upper airways.
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The addition of a heated humidifier may modify the performance of the device.
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There is a risk of air leakage if the tank or side cover is incorrectly refitted, which could lead to a variation in
the pressure applied compared with the prescribed pressure.
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Do not add intermediate parts or accessories to the humidifier that are not listed in the instructions for use
for the humidifier or accessory, otherwise the humidifier or accessory may not function correctly and may
affect the quality of treatment or injure the patient.
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Do not use the humidifier at altitudes above 2500m or outside a temperature range of +5°C to +35°C with
humidifier. Using the humidifier outside this temperature range or above this altitude may affect the quality
of treatment or injure the patient.
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To prevent the tube or tube system from becoming disconnected during use, particularly during ambulatory
use, only tubes complying with ISO 5367 or ISO 80601-2-74 should be used.
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Covering breathing tubes with a blanket or warming them in an incubator or with an overhead electric heater
may affect the quality of treatment or injure the patient.
If the device is equipped with a ModCom or ModCom+ communication module:
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The American HIMA (Health Industry Manufacturers Association) recommends that a minimum separation
of 15 cm be maintained between a wireless telephone and a pacemaker in order to avoid any possible
interference with the pacemaker. In this context, if the Néa device integrates the ModCom or ModCom+
communication module (optional accessory) then it should be considered as a wireless phone.
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Use the ModCom/ModCom+ communication module only for the purpose indicated in this manual.
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Contact your home healthcare provider if you notice any unexplained changes in the performance of the
communication module and if you suspect that this accessory is faulty, degraded or not working properly.
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Do not attempt to open or modify the communication module. Maintenance of this equipment is the
responsibility of competent personnel only.
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The communication module complies with electromagnetic compatibility regulations for medical devices.
If you use a vital medical device such as a pacemaker, contact your doctor and the manufacturer of this
device for further precautions.
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Do not use the communication module in petrol stations, fuel shops, chemical plants and premises
containing explosives.
CAUTION :
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Place the device in a way that nobody can bump into it or trips over the power cord.
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If the device is placed on the floor, ensure that it is in a place free from dust, bedding, clothing or other objects
that may obstruct the air intake.
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After storing or transporting the device, ensure it is used in compliance with the conditions of use specified
in this manual.
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Like all medical electrical devices, the device is vulnerable to interference from mobile and portable
radiofrequency communication equipment (mobile phones, Wi-Fi...).
6 ▪ Product description
Manuel patient NEA Anglais
It means that there is a possibility of material damage to the device or others.
Néa
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