Abbott AMPLATZER Sizing Balloon II Series Manual de instruções de utilização
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Sizing Balloon II
Device Description
The AMPLATZER™ Sizing Balloon II is a triple lumen balloon catheter with three (3) radiopaque marker bands located inside
the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4 mm apart
(inside to inside), and one (1) marker band 15 mm proximal of that pair (15 mm from the proximal edge of the pair of marker
bands) (figure 1).
Figure 1. AMPLATZER™ Sizing Balloon II
Intended Use
The AMPLATZER™ Sizing Balloon II is designed to measure cardiovascular structures. Sizing can be accomplished in two
ways: radiographically or echocardiographically.
Indications for Use
The AMPLATZER™ Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accurate
measurement of the defect is important in selecting the appropriately sized occluder device.
Precautions and Warnings
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to
resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• Do not insert the balloon catheter through an introducer sheath.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2018 Abbott. All Rights Reserved.
Instructions for Use
1
ARTEN600038218A
2018-08
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833