Intended Use - Fahl SILVERVENT Instrucciones De Uso

Silvervent
i. Foreword
these instructions for use are valid for Fahl
patient/user in order to ensure technically correct handling of Fahl
Please read the instructions for use carefully before using the product for the first time!
Keep them in an easily accessible place for future reference.
Please keep the package for as long as you use the tracheostomy tube. it contains important information on the product!
the Fahl tracheostomy tubes are medical devices as defined by the MPG (German medical devices act) and conform to, among others,
®
the "Basic requirements" as per Annex i of Directive 93/42 eeC.
ii. intended Use
Fahl tracheostomy tubes are intended to stabilise the tracheostoma following laryngectomy or tracheostomy.
®
the tracheostomy tube is designed to keep the tracheostoma open.
When used for the first time the products must only be selected, used and inserted by clinicians or medical professionals trained in their
use.
Users must be trained by medical professionals on how to use the Fahl
Overlong tubes can be indicated particularly in cases of deep-seated tracheal stenoses.
Fahl linGO tube variants are intended for tracheotomised patients who retain their larynx or for laryngectomees who use a shunt valve
®
(voice prosthesis users).
iii. Warnings
Patients must be trained by medical professionals on how to use the Fahl
Fahl tracheostomy tubes must never be blocked, e.g. by mucus or encrustation. Blockage can cause asphyxiation!
®
Mucus in the trachea can be aspirated (removed by suction) through the tracheostomy tube with a tracheal suction catheter.
Damaged tracheostomy tubes must not be used and must be discarded immediately. Use of a damaged tube may result in airway com-
promise.
When the tracheostomy tubes are inserted or removed, this can lead to irritations, coughing or slight bleeding. if bleeding persists, con-
sult your doctor immediately!
tracheostomy tubes are single-patient products and intended for use by one patient only.
Do not re-use with another patient. Do not reprocess for re-use by another patient.
Do not use tracheostomy tubes during laser treatment (laser therapy) or with electrosurgical devices! Contact with a laser beam may dam-
age the tube.
in the presence of oxygen-rich mixtures the tube may ignite, which may cause injury from heat and exposure to decomposing and toxic
combustion products.
CAUtiOn
tracheostomy tubes with speech function are only recommended for tracheotomised patients with normal secretion and normal mucous
tissue.
CAUtiOn
if there is strong secretion, a tendency to form granulation tissue, if the patient is undergoing radiation therapy or if scabs have formed, a
perforated cannula version is only recommended under regular surveillance by a doctor and provided that shorter replacement intervals
are observed (as a rule once a week), because the perforations in the outer tube can increase the formation of granulation tissue.
iv. Complications
the following complications could emerge when using this device:
Contamination of the stoma may make it necessary to remove the tube. Contaminations can furthermore cause infections that necessi-
tate the use of antibiotics.
Unintentional inhalation of a tube that was not sized correctly may need to be removed by a doctor/physician. if mucus blocks the tube it
should be removed and cleaned.
v. Contraindications
Do not use if the patient is allergic to the material.
CAUtiOn
never under any circumstances use cannula variants without low-pressure cuff for patients on mechanical respiration!
CAUtiOn
Only use perforated/fenestrated cannula variants during artificial respiration after consultation with the treating doctor/physician.
CAUtiOn
tracheostomy tubes with speaking valves must not be used on any account by laryngectomised patients, as this could lead to serious
complications, even suffocation!
®
tracheostomy tubes. the instructions for use serve to inform the physician, nursing staff and
®
tracheostomy tubes.
®
15
tracheostomy tubes safely and appropriately.
®
tracheostomy tubes safely.
®
EN