Warnings and Precautions
The Tx360EU Nasal Applicator should be used with care only by trained healthcare professionals. Complications may include:
- Nasal passage irritation. Putting anything repetitively in the nose may irritate the lining of the nose. To help avoid irritation, use the device for only a short duration on each side of the nasal passage. Do not use for more than one application. If the tissue the nose is bright red, appears to be irritated, or if the patient is experiencing pain, immediately discontinue using the Tx360EU Nasal Applicator.
- Nose bleeding. Do not force the tip of the Tx360EU Nasal Applicator into the nose. Insert the device slowly and carefully following the step by step instructions described below. If a nose bleeding occurs, immediately stop using the device and hold pressure on the nose to stop bleeding.
Do not use the Tx360EU Nasal Applicator in the following conditions (contraindications):
- If the patient has a nasal septal deformity such as the following: malformed facial or nasal passages such as cleft lip and palate, choanal atresia (narrowed nasal passages), atrophic rhinitis, rhinitis medicamentosa, septal perforation, nasal/midface trauma or if he has recently had nasal/sinus surgery.
* Potential for injury may occur, such as nasal passage obstruction and nasal trauma and irritation.
- If the patient has a bleeding disorder such as Von Willebrand’s disease or hemophilia.
* Uncontrolled bleeding may occur.
- If the patient has severe respiratory distress, as noted by breathing fast or pulling the stomach and rib muscles in when breathing.
* Further irritation of nasal airway may worsen respiratory distress.
- If the patent has a Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma.
* Potential for injury may occur such as nasal passage obstruction and nasal trauma.
- Congestion has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches.
Do not use the Tx360EU Nasal Applicator if:
- The skin around and inside the nasal passage is dry, cracked, oozing, or bleeding.
* The Tx360EU Nasal Applicator may cause nose bleeding and irritation when used in this condition.
- The patient has a nasal or facial fracture.
* The Tx360EU Nasal Applicator may cause additional nasal trauma.
- The patient is a current cocaine user or who uses other drug substances inhaled through the nasal system.
* The Tx360EU Nasal Applicator may cause nose bleeding and additional nasal trauma and irritation.
- The Tx360EU Nasal Applicator is a disposable device for Single Use Only. Not to Be Reused
Discard appropriately after use.
Reuse of the Tx360EU Nasal Applicator may cause serious infections and introduction of bacteria, such as VRE (Vancomycin-Resistant Enterococcus) or MRSA (Methicillin-Resistant Staphylococcus Aureus).