Contraindications; Potential Complications - Merit Medical ENDOTEK AEROSIZER Mode D'emploi

aeroSIZER®
tracheobronchial stent sizing device
devIce descrIptIon
The MerIt endotek™ aeroSIZER® is comprised of the
retractable sizing arms, a shaft, and a three ring handle
(one for the thumb, the other two for the fingers). When
the three- ring handle is contracted, a stiff wire is pulled
through the shaft which in turn opens the sizing arms.
The appropriate MerIt endotek™ aero® or aero dv®
Stent diameter size is determined by observing the
indication window located on the handle when the sizing
arms of the aeroSIZER® lightly contact the walls of the
lumen (aero® Stent sizes 10mm - 18mm). For lumen wall
diameters greater than 18mm, the aeroSIZER® can aid
in determining the nominal lumen size by fully actuating
the sizing arms (18mm) and visually comparing them to
the normal lumen diameter. Markers are provided in 1cm
increments at the distal end of the aeroSIZER® and at the
proximal end of the aeroSIZER® below the handle. The
appropriate MerIt endotek™ aero® or aero dv®
Stent length is determined by referring to these length
markers. The aeroSIZER® is designed for easy tracking
through the working channel of a flexible bronchoscope
or through a rigid bronchoscope (Figure 1).
IndIcatIons for use
The aeroSIZER® is indicated for use in selecting
the appropriate diameter and length of
tracheobronchial or aero dv® Stents. This is a single
use device and is only to be inserted temporarily into the
patient during the sizing procedure.

contraIndIcatIons

The MerIt endotek™ aeroSIZER® Stent Sizing Device
is contraindicated for:
1. Any other use not specified in the Indications for Use
2. Re-use

potentIal coMplIcatIons

Potential complications include, but are not necessarily
limited to:
PROCEDURAL COMPLICATIONS:
• Complications associated with bronchoscopy
addItIonal cautIons and warnInGs
1. The aeroSIZER® Stent Sizing Device should be used
with caution and only after careful consideration in
patients for which bronchoscopy is indicated.
2. This device is only intended to be used through a ≥
2mm working channel of a flexible or rigid
bronchoscope. Do not attempt to introduce this
device into the airways by itself or through an
endotracheal tube or introducer sheath.
Attempting to introduce the device into the airways
by itself can potentially cause:
• Abrasion
• Bleeding
• Vocal cord trauma
• Perforation, tear or laceration of airway
• Epistaxis
• Throat pain
• Laryngospasm
• Hoarseness
3. This device is only intended to be used as a
secondary stent sizing tool to support more
traditional methods of lumen measurement such
as CT scan, balloon sizing and visual sizing by an
experienced operator.
4. Do not use a kinked or damaged bronchoscope
as this may increase the force necessary to actuate
the device and may cause actuation failure or device
breakage.
5. Do not withdraw the aeroSIZER® back into
the bronchoscope when the sizing arms are
open. Withdrawing the aeroSIZER® back into the
bronchoscope when the sizing arms are open may
cause damage to both the device and the
bronchoscope. It may also cause device actuation
failure and/or device separation. If removal of the
device is necessary prior to measuring, make certain
the sizing arms are closed.
cautIon: If the device is damaged, remove the device
and do not attempt to reuse. If the device is damaged and
it cannot be removed from the bronchoscope, the device
and the bronchoscope can be removed en bloc.
6. Do not rotate the aeroSIZER® when the sizing arms
are open. Rotating the aeroSIZER® when the sizing
arms are open may cause damage to both the
device and the bronchoscope. It may also cause
device actuation failure, device deformation, and/or
device separation. If removal of the device is
necessary prior to measuring, make certain the sizing
arms are closed.
recoMMended InstructIons for use
1. locate stenosis and pre-dilate if necessary.
Pass a flexible or rigid bronchoscope into the airway and
beyond the stricture. If the bronchoscope cannot be
passed through the stricture, dilate the stricture using
a balloon catheter dilator until a bronchoscope can be
aero®
passed. Keep the bronchoscope past the stricture for
Step 2.
warnInG: Do not attempt insertion of the AEROSIZER® in
patients with stenoses that cannot be dilated sufficiently
to allow passage of a bronchoscope.
2. How to read the color scale window.
Squeeze the handle GENTLY until the sizing arms are seen
to be slightly touching the walls of the lumen. When the
normal lumen wall diameter is greater than 18mm the
fully actuated sizing arms will not touch the lumen wall
and can be used as a visual reference for sizing the lumen.
Note the color (diameter) indicated in the handle window.
Refer to TABLE 1 for color- to-diameter correlation and
TABLE 2 for recommended stent diameter placement.
TABLE 1. MerIt endotek™aeroSIZER®
Stent Sizing Table
3. determine the diameter of the normal lumen
distal to the stricture.
Insert the aeroSIZER® through the working channel of
the flexible or rigid bronchoscope. When the sizing arms
have exited the distal end of the bronchoscope, locate the
sizing arms in an area of normal lumen diameter. This is
an area distal to the stent target site. With the sizing arms
located in an area of normal lumen diameter, squeeze
the handle GENTLY until the sizing arms are seen to be
slightly touching the walls of the lumen (Figure 2). When
the normal lumen wall diameter is greater than 18mm
the fully actuated sizing arms will not touch the lumen
wall and can be used as a visual reference for sizing the
lumen (Figure 3). Note the color (diameter) indicated in
the handle window. After the color (diameter) has been
noted, close the sizing arms by gently releasing the
handle. Refer to TABLE 1 for color to diameter correlation.
cautIon: For exceptionally large tracheas, the sizing
arms might not reach the walls of the lumen when fully
actuated. In this case, visual sizing by an experienced
operator is required. The normal lumen diameter can be
estimated by comparing the fully actuated sizing arms
(18mm) to the normal lumen diameter.
figure 1.
figure2.
figure 3.
warnInG: Make certain the sizing arms are only slightly
touching the lumen wall when observing the color
indicated in the handle window. The sizing arms can
transmit enough force to the lumen wall to extend or
temporarily dilate the tissue locally.
4. determine the diameter of the lumen at the
stricture before dilation or debulking.
Close the sizing arms by gently releasing the handle.
Slowly retract the flexible or rigid bronchoscope and
the aeroSIZER® proximally until even with the most
narrowed portion of the stricture. Squeeze the handle
GENTLY until the sizing arms are seen to be slightly
touching the walls of the lumen (Figure 4). Note the color
(diameter) indicated in the handle window. After the color
(diameter) has been noted, close the sizing arms by gently
releasing the handle. Apply the same technique to record
color (diameter) at different locations inside the stricture.
If the color (diameter) varies, the physician should refer