How Supplied - Merit Medical ENDOTEK AEROSIZER Mode D'emploi

to the Sizing Tables located in the AERO® and AERO DV®
Instructions for Use. Refer to TABLE 1 for aeroSIZER®
color-to-diameter correlation.
figure 4.
5. determine the diameter of the normal lumen
proximal to the stricture.
Close the sizing arms by gently releasing the handle.
Slowly retract the flexible or rigid bronchoscope and
the aeroSIZER® proximally until the sizing arms are
located in an area of normal lumen diameter. This is an
area proximal to the target stent 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 5). 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 6). 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 5.
figure 6.
6. determine the length of the stricture.
using the distal length Markers.
With the sizing arms closed and the aeroSIZER® tip
flush with the distal end of the bronchoscope, advance
the bronchoscope to the distal end of the stricture. Align
the distal length marker located at the distal end of the
device and the distal end of the bronchoscope evenly
with the distal end of the stricture. While holding the
device stationary, slowly retract the flexible or rigid
bronchoscope proximally through the stricture until the
distal end of the bronchoscope is even with the proximal
end of the stricture. Note the number of length markers
that are passed on the distal end of the device while
retracting the bronchoscope from the distal end of the
stricture to the proximal end of the stricture. Each marker
represents 1cm (Figure 7).
figure 7.
using the proximal length Markers.
With the sizing arms closed and the aeroSIZER® tip
flush with the distal end of the bronchoscope, advance
the bronchoscope to the distal end of the stricture. Align
the distal length marker located at the distal end of the
device and the distal end of the bronchoscope evenly
aeroSIZER® Tracheobronchial Stent Sizing Device 10
with the distal end of the stricture. Note the proximal
length marker that is aligned with the proximal end of the
working channel of the bronchoscope. While holding the
sizing device stationary, slowly retract the bronchoscope
proximally through the stricture until the distal end of
the bronchoscope is even with the proximal end of the
stricture. Note the number of length markers that are
passed on the proximal end of the device while retracting
the bronchoscope from the distal end of the stricture to
the proximal end of the stricture. Each marker represents
1cm.
7. device removal.
Close t he s izing a rms a nd c arefully r emove t he a eroSIZER®
from the working channel of the bronchoscope.
table 2. Stent Diemeter Recommendation
* MERIT ENDOTEK™ recognizes that the practice of medicine
varies from physician to physician and institution to
institution; and therefore, the tables above are provided as
a suggested guideline.
warnInG: Using an AERO® stent in tracheas with a
normal lumen diameter that measures greater than
20mm is not recommended.
8. Sizing the Stent from the Diameters and the Lengths
Recorded. Prior to implantation of the aero®, the
physician should refer to the Sizing Table (Table 1)
located on page 5 in the aero® Instructions for Use. The
AERO® Stent must be sized in accordance with the Sizing
Table and confirmed by using accurate measurement
techniques such as CT scan, balloon sizing and visual
sizing by an experienced operator.
warnInG: Do not attempt to place an aero® Stent in
a stricture that is not in accordance with the Sizing Table
located in the AERO® Instructions for Use.
accuracY stateMent
The AEROSIZER® has a device accuracy of +1mm/-0mm.
packaGInG and labelInG
Inspect the aeroSIZER® Stent Sizing Device and the
packaging for damage prior to use. Confirm that the
device is consistent with the package label. Discard and
replace any damaged devices.
do not atteMpt to repaIr.
Contact Merit Customer Service at 1-800-35-MERIT (1-800-
356-3748) if the package has been opened or damaged.
storaGe
Do not expose this device to conditions of extreme heat
and humidity. Store the aeroSIZER® in a normal room
temperature environment.

How supplIed

The aeroSIZER® is a disposable, non-sterile, single-
patient-use medical device. The aeroSIZER® has a
nominal diameter (OD) of 1.6mm. The working length
of the delivery system is 90cm. The overall length of the
device is approximately 110cm. For more information or
to arrange for a demonstration, contact MERIT ENDOTEK™
at the telephone number shown above.
cautIon: Federal (U.S.A.) law restricts this
r X only:
vice to sale by or on the order of a physician.
cautIon: The aeroSIZER® is provided non-sterile. Do
not use if the outer package is opened or damaged. Each
packaged unit is intended for sInGle-patIent use onlY.
warnInG: The safety and effectiveness of this device for
use in the vascular system have not been established.
warnInG: Do not use this device when the aeroSIZER®
sizing arms cannot be verified visually with an endoscopic
field of view. Do not use this device when the aeroSIZER®
size indicator cannot be verified visually.
reuse precautIon stateMent
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.
warrantY
MERIT ENDOTEK™, Inc. warrants that reasonable care has
been used in the design and manufacture of this device.
This warranty is in lieu of and excludes all other warranties
not expressly set forth herein, whether expressed or
implied by operation of law or otherwise, including, but
not limited to, any implied warranties of merchantability
or fitness. Handling and storage of this device, as well as
other factors relating to the patient, diagnosis, treatment,
implant procedures, and other matters beyond the
control of MERIT ENDOTEK™, Inc. directly affect the
device and the results obtained from its use. The MERIT
ENDOTEK™, Inc. obligation under this warranty is limited
to the replacement of this device, and MERIT ENDOTEK™
shall not be liable for any incidental or consequential loss,
damage, or expense directly or indirectly arising from the
use of this device. MERIT ENDOTEK™ neither assumes, nor
authorizes any other person to assume for it, any other
or additional liability or responsibility in connection
with this device. MERIT ENDOTEK™ assumes no liability
with respect to devices that are reused, reprocessed,
or resterilized and makes no warranties, expressed or
implied, including, but not limited to, merchantability or
fitness for intended use, with respect to such device.
de-