Aeris Ballon-Dilatationskatheter Gebrauchsanweisung Seite 3

Aeris ® Balloon Dilation Catheter
Instructions for Use
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician. This device is for operating room use only.
DEVICE DISCRIPTION
The Aeris ® Balloon Dilation Catheter is comprised of a single lumen catheter with a
high pressure balloon near the distal tip. A stylet is provided to facilitate advancement
of the balloon dilation catheter to the desired location. The stylet must be removed
before inflation of the high pressure balloon. A luer at the proximal end is used for
placement of the stylet and injecting sterile water into the balloon. Two radiopaque
markers, located on the catheter inside the balloon can be used to confirm balloon
placement under Fluoroscopy.
PRODUCT
NUMBER
KG0530
KG0630
KG0730
KG0830
KG0930
KG1030
KG1240
KG1440
KG1640
KG1840
INDICATIONS FOR USE
The Aeris ® Balloon Dilation Catheter is intended to dilate strictures of the airway.
CONTRAINDICATIONS
Balloon dilation of the airway is contraindicated in any patient whose degree of
respiratory failure would not allow the patient to tolerate the manipulation required
to accomplish balloon dilation.
Balloon dilation is contraindicated in the presence of:
• significant active bleeding from the site of the proposed dilation
• and/or presence of a known perforation at the site of proposed dilation
• and/or presence of a known fistula between the tracheobronchial tree and
esophagus, mediastinum or pleural space
WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if
sterile barrier is damaged. If damage is found, call Bryan Medical.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the integrity of this 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 this device
may lead to injury, illness or death of the patient.
PRECAUTIONS
Use the catheter prior to the "Use By" date specified on the package
Store in a cool dry location.
This device should be used only by or under the supervision of a physician thoroughly
trained in airway balloon dilation. A thorough understanding of the technical
principles, clinical application and risks associated with balloon dilation of the airway
is necessary before using this device.
If resistance is met during the procedure do not advance the catheter without first
determining the cause of resistance and taking necessary action.
After use, dispose of product and packaging in accordance with hospital,
administrative and or local government policy.
Intended for single patient use only, DO NOT REUSE.
BALLOON SIZE
(diameter x length)
5 x 30 mm
6x 30 mm
7x 30 mm
8 x 30 mm
9 x 30 mm
10 x 30 mm
12 x 40 mm
14 x 40 mm
16 x 40 mm
18x 40 mm
MAXIMUM
INFLATION
PRESSURE
17 atm
17 atm
17 atm
17 atm
17 atm
17 atm
10 atm
10 atm
10 atm
10 atm
INFLATION DEVICE/
SYRINGE VOLUME
10 cc
10 cc
10 cc
10 cc
10 cc
20 cc
20 cc
20 cc
20 cc
20 cc
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