Fahl LARYVOX PRO HME, Instructions For Use Manual

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5
EN
I. FOREWORD
These instructions for use are valid for LARYVOX
®
PRO HME filter cassettes.
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
LARYVOX
®
PRO HME filter cassettes are particle filters consisting of a foam filter and a plastic housing.
The LARYVOX
®
PRO HME filter cassettes are affixed over the tracheostoma either on a special base
plate with holding ring or on a tracheostomy tube with 22-mm combi-adapter.
LARYVOX
®
PRO HME filter cassettes filter the breathing air, thereby reducing intrusion of particles
into the patient‘s airways.
The filter cassettes reduce the formation of viscous secretions in the lungs. They store the moisture and
warmth of the exhaled air in the filter medium and emit these to the inhaled air again during inspiration.
When used for the first time the products must only be selected, used and inserted by clinicians
or medical professionals trained in their use.
III. PRODUCT DESCRIPTION
1. LARYVOX ® PRO HME filter cassette (REF 49841)
• Normal respiratory resistance
• For patients directly after laryngectomy
• For situations with normal physical exertion
• Plastic housing with outer diameter of 22 mm
• Compatible with all commonly used 22 mm receptacle systems (such as DURAVENT
®
KOMBI tracheostomy tube or LARYVOX
®
Tape base plate)
2. LARYVOX
®
PRO HME HighFlow filter cassette (REF 49840)
• Low respiratory resistance
• For new users of HMEs
• For situations with strong physical exertion
• Plastic housing with outer diameter of 22 mm
• Compatible with all commonly used 22 mm receptacle systems (such as DURAVENT
®
KOMBI tracheostomy tube or LARYVOX
®
Tape base plate)
LARYVOX
®
PRO HME filter cassettes feature:
• a foam filter for heat and moisture exchange (➊a)
• a speaking button (➊b), by means of which the tracheostoma can easily be closed for
speaking
• a closure mechanism (➋a) with a hermetic sealing device (occlusion) in order to protect the
filter from mucus secretions and to enable speaking
• a finger groove (➌a) to enable easy removal of the HME filter cassette from the tracheostoma
housing for coughing
• front and side openings for the airflow to enable unhindered and easy breathing (➌b)
IV. WARNINGS
The LARYVOX
®
PRO HME filter cassettes are only and exclusively allowed to be used by
patients with partially or fully preserved larynx as well as persons wearing voice prostheses
(shunt valves)!
LARYVOX
®
PRO HME filter cassettes are single-patient products and are intended for single
use only. They must not be cleaned or disinfected, as use of disinfectant can render the filter
unusable.
Sterilisation and reuse can impair the function and is therefore not permissible either.
The LARYVOX
®
PRO HME filter cassette must under no circumstances be inserted directly into
the tracheostoma!
V. COMPLICATIONS
If the particle filter is clogged or if signs of clogging appear, the LARYVOX
®
PRO HME filter cassette
must immediately be removed and disposed of.
VI. PRECAUTIONS
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).
LARYVOX
®
PRO HME