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WARNINGS
1.
Do not intubate, reposition, or extubate VivaSight 2 DLT without deflating the cuffs
completely. Movement of VivaSight 2 DLT with inflated cuffs may result in trauma to
the soft tissue.
2.
The surface temperature of the VivaSight 2 DLT may reach above 43 °C when the tube
is placed outside the patient. Therefore, switch off the displaying unit or disconnect
the VivaSight 2 DLT from the displaying unit after the pre-use test. Switch the display-
ing unit back on or reconnect the tube immediately before use to prevent the risk of
having an impact on the tissue.
3.
Do not use an intubation stylet other than the one provided. Using a stylet that pro-
trudes beyond the tube tip can cause damage to vocal cords during intubation.
4.
Ensure cables and tubes from VivaSight 2 DLT do not fall onto patient's eyes during
intubation and use, as this can lead to eye damage.
5.
If stylet is reinserted, make sure only to insert in the bronchial lumen of the VivaSight
2 DLT. Do not insert the stylet in the tracheal lumen of the VivaSight 2 DLT as it will
protrude the tracheal tube exit, which can lead to damage to trachea or vocal cords
during intubation.
6.
VivaSight 2 DLT camera images must not be used for diagnostic purposes. Doing so
may result in incorrect or missing diagnosis, or damage to mucosal membrane or tis-
sue due to excessive movement of tube.
7.
The cuff pressure should not exceed 30 cm H
age the tracheal or bronchial mucosa.
8.
Do not use VivaSight 2 DLT with flammable anaesthetic gases or agents in the imme-
diate area of VivaSight 2 DLT as this can lead to patient injury, damage VivaSight 2 DLT
or disturb image on displaying unit.
9.
Do not use VivaSight 2 DLT with laser equipment and electrosurgical equipment in the
immediate area of VivaSight 2 DLT as this can lead to patient injury, damage VivaSight
2 DLT or disturb image on displaying unit.
10. Patient leakage currents may be additive and too high when using an energised
endoscope in VivaSight 2 DLT. Only energised endoscopes classified as "type CF" or
"type BF" applied part shall be used with VivaSight 2 DLT to minimise total patient
leakage current.
11. Do not attempt to clean and reuse any part of the VivaSight 2 DLT product as they are
single use devices. Reuse of the product can cause contamination leading to infections.
12. Do not reuse the adapter cable on another patient as it is a single patient use device.
Reuse of the adapter cable can cause contamination leading to infections.
13. Do not use the product if the Preparation and Inspection (section 4.1.) of the product
fails as it can cause patient injury.
14. Do not use VivaSight 2 DLT with other connectors than standard 15 mm connectors
for connection to ventilation equipment and circuits, as this can lead to insufficient
ventilation.
15.
Ambu VivaSight 2 DLT is MR Unsafe.
CAUTIONS
1.
Do not use the product if the cuff damaged as it may result in insufficient ventilation,
hypoxia and reintubation. Care must be taken to avoid damaging the cuff during intu-
bation as teeth or any intubation aid with sharp surfaces can damage the cuff.
2.
Before use, always check for compatibility between VivaSight 2 DLT and the external
device (e.g. bronchoscope, suction catheter) to avoid devices not being able to pass
through lumen.
3.
Do not use the flush tube for suctioning as this can occlude the flush tube.
O as over-inflation of the cuffs can dam-
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