Ambu VivaSight 2 DLT 35 Fr Mode D'emploi page 4

1. Important Information – Read Before Use
Read these safety instructions carefully before using the Ambu® VivaSight
instruction for use may be updated without further notice. Copies of the current version are
available upon request. Please be aware that these instructions do not explain or discuss clinical
procedures. They describe only the basic operation and precautions related to the use of
VivaSight 2 DLT. Before initial use of VivaSight 2 DLT, it is essential for operators to have received
sufficient training in oral intubation procedures and to be familiar with the intended use,
warnings and cautions described in these instructions.
There is no warranty on VivaSight 2 DLT.
In this document the term VivaSight 2 DLT refers to the Ambu® VivaSight
adapter cable refers to the Ambu® VivaSight
to information relevant for VivaSight 2 DLT, adapter cable and Ambu displaying unit.
1.1. Intended Use
VivaSight 2 DLT is a sterile, single-use double lumen endobronchial tube intended to be used
for isolation of the left or right lung of a patient for one lung ventilation.
The VivaSight 2 DLT system is intended to be used for verifying tube placement and repositioning.
Intended patient population
VivaSight 2 DLT is intended for adult patients.
Intended use environment
The VivaSight 2 DLT system is for use in operating rooms and intensive care units.
Intended user profile
Medical doctors or nurses under medical responsibility trained within mechanical lung ventila-
tion and anaesthesia. The VivaSight 2 DLT system must be handled in accordance with the
local medical procedures for performing lung ventilation.
1.2. Indications for Use
Intubation with VivaSight 2 DLT is indicated for patients with pathological lung conditions or
other medical conditions that require endobronchial intubation, mechanical ventilation and
isolation of one lung from the other, e.g. for thoracic surgery.
1.3. Contraindications
Use of double lumen tubes is relatively contraindicated in patients with a difficult airway anato-
my, preexisting tracheostomy and limited mouth opening and contraindicated in patients with
distorted airway anatomy and obstruction or stenosis in trachea or left main bronchus.
1.4. Clinical benefits
•
Rapid intubation and successful lung isolation for One Lung Ventilation (OLV).
•
Reduced need to use a bronchoscope to confirm tube position at intubation and
during procedures.
•
Continuous monitoring of tube position during procedures and rapid detection of tube
dislodgement or malposition.
•
Increased patient safety through early detection and adjustment of tube malposition.
1.5. Warnings and Cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the system or patient injury
resulting from incorrect use.
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2 Adapter Cable. The VivaSight 2 DLT system refers
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2 DLT. The
TM
2 DLT and the term
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