HUMIDUAL
I. FOREWORD
These instructions for use are valid for HUMIDUAL
The instructions for use serve to inform the physician, nursing staff and patient/user in order to
ensure technically correct handling.
Please read the instructions for use carefully before using the product for the first time!
II. INTENDED USE
HUMIDUAL
HMEs filter the breathing air, thereby reducing intrusion of particles into the patient's
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airways.
HUMIDUAL
HMEs reduce the formation of viscous secretions in the lungs. They store the
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moisture and warmth of the exhaled air in the filter medium and emit these to the inhaled air again
during inspiration.
Application: spontaneous breathing, tracheotomised adult patients in inpatient or home care.
When used for the first time, the products must only be selected, used and inserted by
appropriately trained physicians or medical professionals.
III. PRODUCT DESCRIPTION
HUMIDUAL
heat-moisture exchangers (HME) consist of a foam filter and a plastic housing
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The plastic housing is equipped on the patient side with a central opening with 15 mm internal
diameter, thereby allowing for connection to a 15 mm standard connector.
The overpressure valve in the lid of the housing prevents an excessive pressure build-up and
allows secretions to be coughed up without having to remove the HME. It minimises the risk of the
moistening medium sticking and allows larger quantities of secretion to be coughed up.
HUMIDUAL
is additionally equipped with an oxygen connecting piece at the side of the housing
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(5 mm plug-in connection), to which a connecting tube can be connected up, thereby allowing for
combination with an oxygen source.
The product was packaged sterile and sterilised with ethylene oxide (EO).
IV. WARNING
HUMIDUAL
HMEs are single-patient products and are intended for single use only. They
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must not be cleaned or disinfected, as use of disinfectant can render the HME unusable.
Cleaning, disinfection, re-sterilisation and re-use can impair the safety and function of the
product and are therefore not permissible!
The HUMIDUAL
HME must under no circumstances be inserted directly into the
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tracheostoma!
Care must be taken to ensure that the valve opening is not blocked by clothing or the like in
order to enable unhindered breathing (risk of respiratory distress).
The HMEs must not be used in conjunction with a nebuliser or atomiser. Do not fill any
water into the HME. This would invariably entail the risk of increased breathing resistance
and thus obstruction of breathing.
V. PRECAUTIONS
If the HUMIDUAL
HME is clogged, or if signs of clogging appear, then the HME must immediately
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be removed and disposed of.
VI. CONTRAINDICATIONS
The HME should be removed if respiratory resistance is too high.
Use in patients with strong exsiccosis (dehydration), or excessive secretion in the lungs
and airways, or strong air leakage flow (exhaled air not flowing through the HME), is not
permissible.
Not for use in patients with impaired consciousness and/or in persons unable to look
after themselves and requiring the help of others, who are not able to remove the HME by
themselves in emergency situations.
The latter does not apply if the patient is in an institution under nursing supervision for 24
hours or in home care.
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HME (Heat-Moisture Exchanger)
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