Abbott AMPLATZER Sizing Balloon II Series Instructions For Use Manual

Abbott AMPLATZER Sizing Balloon II Series Instructions For Use Manual Manual pdf 1 page image

1Manufacturing facility:Abbott Medical5050 Nathan Lane NorthPlymouth, MN55442 USA+1 855 478 5833+1 651 756 5833ARTEN600038218A2018-08™ 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.Device DescriptionThe AMPLATZER™ Sizing Balloon II is a triple lumen balloon catheter with three (3) radiopaque marker bands located insidethe 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 markerbands) (figure 1).Intended UseThe AMPLATZER™ Sizing Balloon II is designed to measure cardiovascular structures. Sizing can be accomplished in twoways: radiographically or echocardiographically.Indications for UseThe AMPLATZER™ Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accuratemeasurement 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 toresterilize 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.Figure 1. AMPLATZER™ Sizing Balloon IISizing Balloon IIInstructions for Use