Description Of The Device; Indications For Use; Contraindications - Teleflex RÜSCH EZ-BLOCKER KIT Gebrauchsanweisung

940659 Ez-Blocker 13spr:Layout 1
RÜSCH EZ-BLOCKER™ KIT
Instructions for Use
The EZ-Blocker kit contains the following sterile products:
1 EZ-Blocker
1 EZ-Multiport™ Adapter with scope lid
1 Oxygen Adapter
2 Dust caps
Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.

Description of the Device:

The EZ-Blocker is an endobronchial blocking device intended for use in airway management.
The EZ-Blocker is an endobronchial blocker with two distal extensions, both with an inflatable cuff and
a central lumen. The shaft, the two distal extensions and the two distal tips are made of radiopaque
material. The two distal extensions are colored differently for identification purposes. In addition "blue
stripes" are used as symbols to identify the blue distal extension for CPAP purposes (Fig. 2). These
color and symbolic identifications (Fig. 2) are repeated on each corresponding balloon assembly for cuff
inflation. Printed depth markers indicate the distance to the distal tip of the EZ-Blocker. This device is
intended for use through a standard single lumen endotracheal tube to provide lung isolation. Fiberoptic
or video bronchoscopy should be used for placement and proper positioning. The EZ-Multiport Adapter
is designed for connection to ventilation devices, and allows introduction of a fiberoptic or video
bronchoscope and the EZ-Blocker, or a suction catheter.

Indications for Use:

The EZ-Blocker is indicated for use to intubate the patients bronchi in order to differentially isolate the
left or right lung for procedures which require one-lung ventilation, lung separation. Patient population:
Patients requiring one lung isolation.
Environment of use: Hospitals – OR Operating Room and ICU Intensive Care Unit.

Contraindications:

• Internal endotracheal tube diameter too small to facilitate both the EZ-Blocker and a fiberoptic or
video bronchoscope.
• Airway diameter insufficient to allow introduction and passage of the EZ-Blocker.
• When equipment for fiberoptic or video bronchoscope is not available.
• Use of LASER or electrosurgical electrode in the immediate area of the EZ-Blocker.
• Known allergy to polyurethane.
Warnings:
• When both devices are situated in the tube at the same time this may result in hypoxemia and high
ventilation pressures.
• The surgeon should be aware of the location of the cuff in order to prevent damage, especially while
working near the hilum.
• In the case of a sudden drop in saturation, or rise in ventilation pressure, immediate fiberoptic or video
bronchoscope control is mandatory.
• The EZ-Blocker™ should be advanced with care and never be forced down the tube.
• The EZ-Blocker should not be advanced if any resistance is encountered.
• If ventilation worsens acutely during endobronchial blockade, the cuff should be deflated immediately
and the cuff position should be inspected.
• Adequate ventilation may be impaired due to the presence of a fiberoptic or video bronchoscope and
the EZ-Blocker in the endobroncheal tube, at the same time. This may result in higher peak- and
expiratory pressures.
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