HUMIDOFIX
I. FOREWORD
These instructions for use are valid for HUMIDOFIX
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
HUMIDOFIX
HMEs filter the breathing air, thereby reducing intrusion of particles into the patient's
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airways.
HUMIDOFIX
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
HUMIDOFIX
are particle filters consisting of a paper filter (cellulose) and a transparent plastic
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housing.
The paper filter consists of a hydrophilic, moisture-binding material.
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 product was packaged sterile and sterilised with ethylene oxide (EO).
IV. WARNING
HUMIDOFIX
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.
CAUTION!
Cleaning, disinfection, re-sterilisation and re-use can impair the safety and function of the
product and are therefore not permissible!
The HUMIDOFIX
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 HUMIDOFIX
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immediately 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.
VII. INSTRUCTIONS
1. Carefully examine the sterile packaging to ensure that it has not been tampered with or damaged.
Do not use the product if the packaging has been damaged.
2. Check the use-by or expiry date. Do not use the product after this date.
3. Fit the HME with the central 15 mm opening onto the 15 mm standard connector of the
tracheostomy tube by exerting light pressure ➊.
4. Check the respiratory resistance.
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HME is clogged, or if signs of clogging appear, then the HME must
HME (Heat-Moisture Exchanger)
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