Edwards eSheath+ 914ESP Instrucciones De Uso

Edwards eSheath+ Introducer Set
Conjunto de introductor Edwards eSheath+
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English
Instructions for Use
This product should be used by physicians trained and experienced in interventional techniques.
1.0 Device Description
The Edwards eSheath+ introducer set contains one introducer, one dilator, one expansion tool and a sheath, as well as a loader packaged with an Edwards
delivery system. The working lengths of the introducer, dilator, and sheath contain a hydrophilic coating.
Model Sheath I.D.
914ESP 14 F
916ESP 16 F
2.0 Indications
The Edwards eSheath+ introducer set is indicated for the introduction and removal of devices used with the Edwards transcatheter heart valves.
3.0 Contraindications
There are no known contraindications.
4.0 Warnings
The devices are designed, intended, and distributed for single use only.
Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.
The Edwards eSheath+ introducer set must be used with a compatible 0.035" (0.89 mm) guidewire to prevent vessel injury.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards eSheath, Edwards eSheath+, eSheath, and eSheath+ are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their respective owners.
Directory ■ Directorio
Expansion Tool
Sheath Working
Length Compatible THV
20 mm
36 cm 23 mm
26 mm
36 cm 29 mm
Sheath
Introducer
Dilator
Introducer
Introducer O.D. Working Length
14 F 57 cm
16 F 57 cm
1
Dilator Working
Dilator O.D. Length
16 F 38 cm
18 F 38 cm