Storage And Transportation; Adverse Events - ETView VIVASIGHT-EB Instrucciones De Uso

CONTRAINDICATIONS
VivaSight-EB is contraindicated for use
in procedures involving the use of laser
equipment in the immediate area of the device.
VivaSight-EB is not recommended for use
on patients with serious throat edema or
inflammation, hemorrhage, neck vertebra
trauma or wet lung.
WARNINGS
•
VivaSight-EB 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.
•
Expert clinical judgment should be used
in selecting the suitable tracheal tube
size for each patient. Use the same size
VivaSight-SL as the standard tube size
required in combination with VivaSight-EB.
•
Make sure the cuff is completely
deflated prior to inserting or removing
VivaSight-EB.
•
Do not attempt to resterilize any part of
VivaSight-EB.
•
Prior to use, check that the pouch seal
is intact and there are no impurities or
damage on the product such as rough
surfaces, sharp edges or protrusions
which may harm the patient.
•
Do not use VivaSight-EB if the cuff is
damaged. Care must be taken to avoid
damaging the cuff during use.
•
The cuff pressure should not exceed
20 cm H O. Diffusion of a nitrous oxide
2
mixture, oxygen, or air may either
increase or decrease the cuff pressure.
•
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.
CAUTIONS
•
VivaSight-EB is intended for use by
trained personnel only.
•
Use a water-soluble lubricant only. Other
lubricants might affect the cuff.
•
The use of lidocaine topical aerosols
has been associated with the formation
of pinholes in PVC cuffs*. To prevent cuff
leaks, expert clinical judgment is required
when using lidocaine topical aerosols.
* Jayasuriya KD, Watson WF: "P.V.C. cuffs and
Lidocaine-based aerosol"; Br J Anaesth.
1981 Dec; 53 (12): 1368.
•
Use a cuff pressure gauge to help
monitor and adjust the cuff pressure.
inflation of the cuff by "feel" alone or
by using a measured volume of air is
not recommended as resistance is an
unreliable guide during inflation.
•
Syringes, stopcocks, or other devices
should not be left in the inflation system
for an extended period.

STORAGE AND TRANSPORTATION

•
Store and transport VivaSight-EB at
temperatures between 0° C and 42° C,
relative humidity between 10-100% and
atmospheric pressure between 80-109 kPa.
•
Store in a dry, cool and dark place.

ADVERSE EVENTS

Reported adverse reactions associated with
the use of endobronchial blockers are many
and diverse. Adverse events associated with
the use of VivaSight-EB are the same as those
for standard endobronchial blockers. Potential
adverse events related to endobronchial
blockers include perforating a bronchus or
lung parenchyma, causing pneumothorax;
mistakenly inflating the bronchial cuff near the
tracheal lumen, producing respiratory arrest;
developing severe hypoxemia and potential
pulmonary edema following continuous
suctioning of the nondependent lung by
the blocker.
5