Boston Scientific WATCHMAN 12F Instrucciones De Uso página 2

table of contents
warnInG ......................................................................................................................................3
DevIce DescrIptIon .................................................................................................................3
Contents ....................................................................................................................................3
IntenDeD Use/ InDIcatIons for Use .................................................................................3
contraInDIcatIons .................................................................................................................3
warnInGs ....................................................................................................................................3
MaGnetIc resonance IMaGInG ..........................................................................................3
3.0 Tesla Temperature Information .......................................................................................3
1.5 Tesla Temperature Information .......................................................................................3
Image Artifact Information .....................................................................................................4
precaUtIons...............................................................................................................................4
aDverse events ........................................................................................................................4
How sUpplIeD.............................................................................................................................4
HanDlInG anD storaGe .........................................................................................................4
operatIonal InstrUctIons..................................................................................................4
Pre-Procedural Instructions ..................................................................................................4
proceDUral InstrUctIons ...................................................................................................4
Equipment Needed for Implantation Procedure .................................................................4
Figure 1. WATCHMAN™ Delivery System (Delivery Catheter and Device) ..............4
• access sheath ..................................................................................................................4
• Dilator ................................................................................................................................4
Figure 2. WATCHMAN Access System (Access Sheath/Dilator) ...............................4
Implantation Procedure ..........................................................................................................4
TABLE 1. WATCHMAN LAA Closure Device Selection .................................................5
Figure 3. WATCHMAN Access Sheath and Pigtail Catheter .......................................5
Figure 4: WATCHMAN Access Sheath Marker Bands .................................................5
Figure 5. WATCHMAN LAA Closure Device Position and Size ...................................6
TABLE 2. WATCHMAN LAA Closure Device Diameter .................................................6
warranty ...................................................................................................................................6
Black (K) ∆E ≤5.0
2
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