CooperSurgical NEO-fit Gebrauchsanleitung

42-2540• NEO-fit™ Neonatal Endotracheal Tube Holder
DEVICE DESCRIPTION
Includes one plastic tube grip with
adjustable hook and loop strap and
adhesive foam foot pads, two foam
"lollipop" securing tapes. Adjustable hook
and loop strap allows rapid release and
adjustment of ET tube. This product is
non-sterile.
Plastic Base
Adhesive Liner
Figure 1
CAUTION: U.S. Federal law restricts this
device to sale by or on the order of a
physician.
INTENDED USE
For stabilizing a 2.5 mm to 4.0 mm ID
Neonatal ET tube.
CONTRAINDICATIONS
None known.
PRECAUTIONS
• Not for use with 2.0 mm ID or smaller ET
tube.
• Do not use as sole method of support for
ventilator tubes; use a tubing support
device.
• Patient must be under professional
supervision while intubated.
• Do not wrap the tube holder too tightly or
the ET tube may be deformed and
prevent suction catheter passage.
• Do not wrap the tube holder too loosely
or the ET tube may move in the tube
holder.
Directions for Use • English
Strap
Tyvek Tab
Foam Pad
WARNINGS
• Separation of the plastic base foot from
the adhesive foam pad may result in
potential ET tube extubation. If signs of
delamination are observed, replace with
a new NEO-fit™.
• Usage of ointments or oils may
adversely affect the adhesion properties
of the adhesive foam pad.
• Excessive salivation may adversely
affect the attachment of this device or
cause the device to fail during use.
• Discontinue use immediately if skin
irritation occurs.
• For single use only. Do not reuse,
reprocess or resterilize. Reuse,
reprocessing or resterilization may
compromise the structural integrity of the
device and/or lead to device failure
which, in turn, may result in patient
injury, illness or death. Reuse,
reprocessing or resterilization may also
create a risk of contamination of the
device and/or cause patient infection or
cross-infection, including, but not limited
to, the transmission of infectious
disease(s) from one patient to another.
Contamination of the device may lead to
injury, illness or death of the patient.
Dispose of in accordance with all
applicable Federal, State, and local
Medical/Hazardous waste practices.
ADVERSE EVENTS
• Skin irritation
• ET tube extubation
422540-DFU • Rev. A • 7/13