Indications For Use - ETView VIVASIGHT-EB Instrucciones De Uso

ENGLISH
VIVASIGHT- EB
VIVASIGHT-EB
STERILE (ETO) unless package has been
opened or damaged.
FOR SINGLE USE ONLY.
DO NOT REUSE.
Federal (US) law restricts this device to sale
by or on the order of a physician.
DESCRIPTION
VivaSight-EB is a single-use endobronchial
blocker designated for one-lung ventilation.
VivaSight-EB is used in combination with
VivaSight-SL or equivalent Endotracheal
tube. VivaSight-EB features a blue silicone
cuff. VivaSight-EB can be deflated and
repositioned under visual control provided
by VivaSight-SL. The angled distal tip of
VivaSight-EB can be adjusted to facilitate
navigation to the bronchi.
Evacuation
port
Blocker tube
Bronchoscope
port
Anesthesia
circuit
4
Valve
Pilot
balloon
3-way
connector
Twist lock
Multi-joint
connector
Tube
connector
Cuff

INDICATIONS FOR USE

VivaSight-EB is use to isolate the left or right
lung of a patient in surgery, that requires
one lung ventilation or one lung anesthesia.
Absolute
1. Avoid contaminating a non-diseased lung
a. Infection (e.g., unilateral pulmonary
abscess)
b. Massive pulmonary hemorrhage
c. Unilateral
(e.g., pulmonary alveolar proteinosis)
2. Controlling distribution of ventilation
a. Bronchopleural fistula
b. Bronchopleural cutaneous fistula
c. Surgical opening of a major
conducting airway
d. Giant unilateral lung cyst or bulla
e. Tracheobronchial tree disruption
f. Life-threatening hypoxemia due to
unilateral lung disease
3. During video-assisted thoracoscopy (VAT)
Relative
1. High priority
a. Thoracic aortic aneurysm repair
b. Pneumonectomy
c. Pulmonary resection via median
sternotomy
d. Upper lobectomy
e. Lung transplantation
2. Medium priority
a. Middle and lower lobectomies and
subsegmental resections
b. Esophageal resection
c. Thoracic spine procedures
3. Other
a. Post-cardiopulmonary bypass status
after removing totally occluding
chronic unilateral pulmonary emboli
b. Unilateral lung disease causing severe
hypoxemia
pulmonary lavage