ILLUMISITE™ Platform

The ILLUMISITE platform is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

WARNING: The ILLUMISITE platform may only be used by a qualified bronchoscopist.

CONTRAINDICATIONS:

Flexible bronchoscopy should be performed only when the relative benefits outweigh the risks. Absolute contraindications include, but are not limited to:

• Absence of consent from the patient or his/her representative, unless a medical emergency exists and the patient is not competent to give consent.
• Lack of adequate facilities and personnel to care for emergencies such as cardiopulmonary arrest, pneumothorax, or bleeding.
• Inability to adequately oxygenate the patient during the procedure.
• For large patients, inability to place all three patient sensors within the sensing volume.

The danger of a serious complication from bronchoscopy is especially high in patients with the disorders listed below. These conditions are usually considered absolute contraindications, unless risk-benefit assessment warrants the procedure:

• Coagulopathy or bleeding diathesis that cannot be corrected.
• Severe obstructive airways disease.
• Severe refractory hypoxemia.
• Unstable hemodynamic status including dysrhythmias.

Relative contraindications or conditions involving increased risk for Fiber-optic Bronchoscopy in adults include but are not limited to:

• Recent myocardial infarction or unstable angina.
• Uremia and pulmonary hypertension (possibility of serious hemorrhage after biopsy).
• Lung abscess (danger of flooding the airway with purulent material).
• Respiratory failure requiring mechanical ventilation.
• Known or suspected pregnancy (because of radiation exposure).