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WARNINGS
1. Do not intubate, reposition, or extubate VivaSight 2 SLT without deflating the cuff
completely. Movement of the VivaSight 2 SLT with an inflated cuff may result in
trauma to the soft tissue.
2. The surface temperature of the VivaSight 2 SLT may reach above 43 °C when the tube
is placed outside the patient. Therefore, switch off the displaying unit or disconnect
the Viva Sight 2 SLT from the displaying unit after the pre-use test. Switch the
displaying 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
protrudes beyond the tube tip can cause damage to vocal cords during intubation.
4. Ensure cables and tubes from the VivaSight 2 SLT do not fall onto patient's eyes during
intubation and use, as this can lead to eye damage.
5. VivaSight 2 SLT camera images must not be used for diagnostic purposes. Doing so
may result in incorrect or missing diagnosis, or damage to mucosal membrane or
tissue due to excessive movement of tube.
6. The cuff pressure should not exceed 30 cmH2O as over-inflation of the cuff can
damage the tracheal mucosa.
7. Do not use VivaSight 2 SLT with flammable anaesthetic gases or agents in the
immediate area of VivaSight 2 SLT as this can lead to patient injury, damage Viva-Sight
2 SLT or disturb image on displaying unit.
8. Do not use VivaSight 2 SLT with laser equipment and electrosurgical equipment in the
immediate area of VivaSight 2 SLT as this can lead to patient injury, damage VivaSight
2 SLT or disturb image on displaying unit.
9. Patient leakage currents may be additive and too high when using an energised
endoscope in VivaSight 2 SLT. Only energised endoscopes classified as "type CF" or
"type BF" applied part shall be used with VivaSight 2 SLT to minimise total patient
leakage current.
10. Do not attempt to clean and reuse any part of the VivaSight 2 SLT product as they are
single use devices. Reuse of the product can cause contamination leading to infections.
11. 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.
12. Do not use the product if the Preparation and Inspection (section 4.1.) of the product
fails as it can cause patient injury.
13. Do not use VivaSight 2 SLT with other connectors than standard 15 mm connectors
for connection to ventilation equipment and circuits, as this can lead to insufficient
ventilation.
14.
VivaSight 2 SLT is classified as MR unsafe. It is recommended to reintubate the
patient with an alternative MR conditional product if MRI scan is clinical indicated.
15. In cases with obstruction of upper airway due to pathology or foreign body, risk of
failure with intubation is increased. Consider alternative method or device.
CAUTIONS
1. Do not use the product if the cuff is damaged as it may result in insufficient ventilation,
hypoxia and reintubation. Care must be taken to avoid damaging the cuff during
intubation as teeth or any intubation aid with sharp surfaces can damage the cuff.
2. Before use, always check for compatibility between the SLT and the external device
(e.g. endobronchial blocker (EBB), bronchoscope, suction catheter) to avoid devices
not being able to pass through lumen.
3. Do not intubate the patient with the VivaSight 2 SLT through a laryngeal mask, as
it will not be possible to remove the mask as the video connector is too large to fit
through the mask.
4. Caution should be taken when using suction catheter and EBB in VivaSight 2 SLT at the
same time, as more devices in the lumen may cause devices to block for each other.
5. Do not use the flush tube for suctioning as this can occlude the flush tube.
6. When intubating patients with soiled airways beware that visualization may be
impaired during intubation due to secretion on the camera lens. Recover visualization
by flushing camera when possible.
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