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Abbott AMPLATZER Sizing Balloon II Series, Instructions For Use Manual

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Abbott AMPLATZER Sizing Balloon II Series Instructions For Use Manual Download Page 6

6

Hydrophilic coating 

Recommended delivery sheath/catheter dimensions

Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed 
practitioner).

Contains phthalate

Quantity

Date of manufacture

Sizing Balloon

ONLY

Sizing Balloon

Summary of Contents for AMPLATZER Sizing Balloon II Series

Page 1: ...e 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 ...

Page 2: ...ocedure Carefully inspect the sterile pouch and verify that it is unopened and undamaged Gently open the sterile pouch and inspect the balloon catheter prior to use to verify that it is undamaged Slowly slide the protective cover off the balloon segment Avoid acute bends or kinking of the AMPLATZER Sizing Balloon II during removal from the packaging The procedure will vary according to the type of...

Page 3: ...achieve the best angle for size measurement 8 Inflate the balloon until the right to left shunt ceases and a stop flow condition is observed by Doppler observation Slightly deflate the balloon and gradually re inflate to the minimum balloon diameter that achieves a stop flow condition A minimal balloon waist may or may not be present WARNING Do not inflate the balloon beyond the stop flow point or...

Page 4: ...n under this warranty is limited to replacing or repairing at its option at its factory this product if returned within the warranty period to Abbott Medical and after confirmed to be defective by the manufacturer EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY ABBOTT MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND EXPRESS OR IMPLIED INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNE...

Page 5: ...uct serial number Batch Code Use by date Use on or before the last day of the expiration month noted on the product packaging Do not reuse Sterilized using ethylene oxide Unique device identification Consult instructions for use Follow instructions for use on this website Keep dry Do not use if package is damaged Not made with natural rubber latex Inner diameter Outer diameter Length Usable length...

Page 6: ...d delivery sheath catheter dimensions Federal law USA restricts this device to sale by or on the order of a physician or properly licensed practitioner Contains phthalate Quantity Date of manufacture Sizing Balloon ONLY Sizing Balloon ...

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