Alaxo AlaxoLito, Instructions For Use Manual, Page: 30 / 108

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1.4 Symbols and indications
• The AlaxoLito Nasal Stent may be used for 18 months after first use.
• In the instructions for use, on packagings and on the product the figures and
symbols in XX are used.
1.5 Precautionary measures
The attending doctor has to explain handling of the AlaxoLito Nasal Stent to
the patient. Especially, the doctor has to explain correct application and
positioning of the AlaxoLito stent in the nose and its removal.
The attending doctor has to advise on potential risks and complications
connected to the AlaxoLito Nasal Stent therapy and has to evaluate if the
AlaxoLito therapy is applicable to the specific patient.
2 Product information
2.1 Intended use
• The AlaxoLito Nasal Stent is a medical device and self-applied by the
patient. The AlaxoLito stent is positioned in the nasal cavity in order to
mechanically splint the nasal airway.
• The AlaxoLito Nasal Stent splints the anterior middle or inferior nasal
passage. The AlaxoLito Plus/Xtreme/Sport Nasal Stent splints the middle or
inferior nasal passage over its entire length. The AlaxoLito Nasal Stent can
be used to treat nasal valve or nasal alar collapse and turbinate hyperplasia
as well as poten-tially resulting snoring.
• The AlaxoLito Nasal Stent is a CE marked and prescription medical device. •
The attending doctor has to examine if the AlaxoLito Nasal Stent is an
appropriate therapy for the patient and if the nasal cavities and passages of
the patient are appropriate for application of the AlaxoLito stent.
• The AlaxoLito Nasal Stent must be used only by one single patient.
• The AlaxoLito Nasal Stent is suitable for repeated use up to 18 hours per
application.
• The AlaxoLito Nasal Stent must be used only by patients of age of 18 years
and higher.
• The AlaxoLito Nasal Stent is not suitable for life-supporting application in
emergency care.
2.2 Contraindications
• Inappropriate structure of the nasal passages, especially if leading to
problems during insertion of the introduction tube into a nasal passage