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Safety information
INTENDED USE
- The RhinoChill® IntraNasal Cooling System is intended for temperature reduction in patients, with a protected airway, where clinically indicated.
- The RhinoChill® IntraNasal Cooling System is intended for rapid induction of hypothermia during cardiac arrest and following resuscitation, in patients with a protected airway, in a field or hospital setting.
CONTRAINDICATIONS
Patients with known contraindications to hypothermia (Raynaud’s disease, Cryoglobulinemia, Sickle Cell disease), have specific temperature-sensitive pathologies (e.g., serum cold agglutinins, Buerger’s disease), have bleeding disorders, require oxygen supplied at >50% FiO2 to maintain normal saturation (>94%), have an intranasal obstruction preventing full insertion of nasal catheters, or known base of skull fracture, should not be treated with the BeneChill RhinoChill® System.
WARNINGS
- Use the RhinoChill® Tubing Set only with the other RhinoChill® System components.
- Use the RhinoChill® Control Unit only with the other RhinoChill® System components.
- Use the RhinoChill® Coolant only with the other RhinoChill® System components.
- Use only the supplied power adaptors to recharge the RhinoChill® Control Unit.
- USE ONLY MEDICAL GRADE OXYGEN OR BREATHING AIR.
- Laser radiation – avoid direct eye contact
- The RhinoChill® System should not be used in patients without a protected airway.
- The RhinoChill® System should not be used in pregnant women.
- The RhinoChill® has not been tested in persons under 18 years of age; neither safety nor effectiveness has been proven in this population.
- Control Unit must remain in the upright position while in use.
