Indications For Use - ETView VivaSight-SL Bedienungsanleitung

ENGLISH
VIVASIGHT-SL
STERILE (ETO) unless package has been
opened or damaged.
DO NOT REUSE.
Federal (US) law restricts this device to
sale by or on the order of a physician.
DESCRIPTION
Note: VivaSight-SL is the brand name for
the ETView Tracheoscopic Ventilation
Tube (TVT ).
TM
VivaSight-SL is a single-use, cuffed PVC
endotracheal tube with an embedded
video imaging device and light source
at its tip, and an integrated single use
video/power cable (adapter cable) with
connector. VivaSight-SL displays images
of the airway onto the Ambu® aView
monitor for as long as the device remains
in place during intubation.
VivaSight-SL has two Murphy eyes
flanking the 45° bevel tip. In addition
to the cuffed inflation tube, VivaSight-
SL has an injection port for imaging
lens cleaning that leads to two lumens
running along the tube's wall and opens
distally to the imaging lens. The port is
used for cleaning the lens with air, saline,
or other appropriate solutions.

INDICATIONS FOR USE

The ETView Tracheoscopic Ventilation
Tube (TVT ) is intended for intubation
TM
procedures. The ETView Tracheoscopic
Ventilation Tube (TVT
use as a temporary artificial airway in
adults requiring mechanical ventilation.
It is intended for oral intubations.
The TVT System is indicated for
TM
viewing during non-difficult and difficult
intubation procedures, for verifying
endotracheal tube and endobronchial
blocker placement and repositioning,
for viewing during suctioning and for
general inspection of the airway.
4
TM
) is indicated for
TM
CONTRAINDICATIONS
Do not use laser equipment in the
immediate proximity of the VivaSight-SL.
ACCESSORIES
Stylet.
WARNINGS
• VivaSight-SL is a single use product.
Do not reuse: After use, handle and
dispose according to local regulations
for disposal of infected medical devices.
Reuse of this single use product may
create a potential risk to the user.
Reprocessing, cleaning, disinfection
and sterilization may compromise
product characteristics which in turn
create an additional risk of physical
harm to or infection of the patient.
• Do not attempt to resterilize any part
of VivaSight-SL.
• Do not connect VivaSight-SL into
any device or outlet other than those
supplied by ETView or Ambu.
• The intended performance of the
VivaSight-SL is reached only with the
disposable devices and accessories
provided or specified by Ambu or
ETView.
• VivaSight-SL is available in tube
sizes of 7 mm, 7.5 mm and 8 mm
(internal diameter) and should be
used for patients who require one
of these sizes.
• Do not use the injection port for
suctioning the patient.
• The cuff pressure should not exceed
25 cm H O. Diffusion of a nitrous oxide
2
mixture, oxygen, or air may either
increase or decrease the cuff pressure.
• Do not use the camera in the event that
inspired gas temperature exceeds 34
°C for an artificially ventilated patient.
• Do not overinflate the cuff. Overinflation
can result in tracheal damage, rupture
of the cuff with subsequent deflation,
or cuff distortion, which may lead to
airway blockage.
• Do not use the tube if the cuff is
damaged. Care must be taken to avoid