7
7.0 Directions for Use
7.1 Required Equipment
Table 4:
Product Name
20 mm System
(9600CM20A)
23 mm System
(9600CM23A)
26 mm System
(9600CM26A)
29 mm System
(9600CM29A)
Transcatheter Heart
9600TFX (20 mm) 9600TFX (23 mm) 9600TFX (26 mm) 9600TFX (29 mm)
Edwards Commander
Delivery System*
9600LDS20 9600LDS23 9600LDS26 9600LDS29
Edwards eSheath
Introducer Set**
914ES 914ES 914ES 916ES
9350BC16 9350BC20 9350BC23 9350BC25
Inflation devices provided by Edwards Lifesciences
Edwards Crimper 9600CR
* Includes the Qualcrimp Crimping Accessory,2-piece Crimp Stopper and loader
** Or other compatible sheath provided by Edwards Lifesciences
Additional Equipment:
• 20 cc syringe or larger (x2)
• 50 cc syringe or larger
• High-pressure 3-way stopcock (x2)
• Standard cardiac catheterization lab equipment
• Fluoroscopy (fixed, mobile or semi-mobile fluoroscopy systems appropriate for use in percutaneous
coronary interventions)
• Transesophageal or transthoracic echocardiography capabilities
• Exchange length 0.035 inch (0.89 mm) extra-stiff guidewire
• Temporary pacemaker (PM) and pacing lead
• Sterile rinsing basins, physiological saline, heparinized saline, 15% diluted radiopaque contrast
medium
• Sterile table for valve and device preparation
7.2 Valve Handling and Preparation
Follow sterile technique during device preparation and implantation.
7.2.1 Valve Rinsing Procedure
Before opening the valve jar, carefully examine for evidence of damage (e.g. a cracked jar or lid, leakage,
or broken or missing seals).
CAUTION: Valves from containers found to be damaged, leaking, without adequate sterilant, or
missing intact seals must not be used for implantation.
To Next Page
Loading...
Need help?
General
