CardioFocus HeartLight X3 Manual De Instrucciones página 7

• Adverse reaction to anesthesia
• Air Embolism
• Anemia
• Anxiety
• Aspiration Pneumonia
• Atrio-esophageal fistula, esophageal
ulceration, or esophageal tear
• Arteriovenous (AV) fistula
• Back pain
• Bleeding from puncture site
• Blood Clot / Thrombotic / thromboembolic
event / Deep Vein Thrombosis
• Blurred vision or vision changes
• Bradycardia
• Bronchitis
• Bruise
• Cardiac perforation / tamponade / tear
• Cardiopulmonary arrest
• Chest pain / discomfort / pressure
• Complete heart block
• Coronary artery spasm, dissection thrombosis
• Cough
• Death
• Diarrhea
• Dizziness/vertigo
• Dysphagia
• Esophago-mediastinal fistula
• Fatigue
• Fever
• Headache
• Hematoma / ecchymosis
• Hemothorax
• Hemorrhage
• Hemoptysis
6. Sterilization/ "Use By" Date
• The Balloon Catheter have been sterilized with ethylene oxide gas.
Use the Balloon Catheter prior to the "Use by" date shown on the package label.
•
• Do not use the device if the package is open or damaged.
7. Instructions for Use
7.1 BALLOON CATHETER PREPARATION
For detailed instructions on preparation and proper connection of the Balloon Catheter to the Console, please refer
to the HeartLight X3 Endoscopic Ablation System Operation and Maintenance Manual 06-4955.
1. Using a 50-60cc syringe and needle (≤18 gauge), aseptically transfer Balloon Fill Media from the rubber
stoppered glass vials into the syringe. Note: 70cc of Balloon Fill Media is required to purge the system.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
• Hypertension/ hypotension
• Incision site pain or tenderness
• Infection
• Major Bleeding
• Myocardial Infarction
• Nausea/vomiting
• Nerve injury
• Neurological deficits
• Pain or severe coughing during energy
delivery
• Pericardial effusion
• Pericarditis
• Phrenic nerve damage leading to
diaphragmatic paralysis
• Phrenic nerve palsy
• Pneumothorax
• Pleural effusion
• Pseudo-aneurysms
• Pulmonary edema
• Pulmonary Vein Stenosis/ Occlusion
• Pyrogenic reaction
• Scarring
• Sepsis
• Shortness of breath
• Stroke / Transient Ischemic Attack (TIA) /
cerebrovascular accident
• Tachyarrhythmia
• Ulceration
• Urinary infection
• Wound healing difficulties
• Valvular damage
• Vascular complication requiring surgery
• Vascular damage / tear
• Vasovagal reactions
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