Endotronix Cordella, Инструкция по эксплуатации

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Instructions For Use |
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© 2018 Endotronix Inc.
100474-00 Rev 1
2.6 Recommended Accessories
Cordella Pulmonary Artery Sensor System is recommended for use with
the accessories listed in the following table. These accessories are not
included in the Cordella Sensor and Delivery System packaging.
Item Specifications
Vascular Access Kit 14 Fr Introducer Sheath (see
recommendation) and dilators
with preferred access guidewire (no
Endotronix recommendation)
14F Introducer Sheath Cook performer introducer, Item No.
G08024 RCF 14.0-38J-14F - 13cm length
PA Catheter Swan-Ganz thermodilution pulmonary
artery catheter
Procedural Guidewire Stiff Amplatz Guidewire (260cm;
straight-tip; 0.025” or 0.018”)
Pigtail catheter 6F pigtail catheter (ID>0.06”)
Additionally, Endotronix recommends use of the following catheter lab
equipment and supplies during Cordella Sensor implantation. They are the
same items typically used during right heart catheterization procedures.
• Fluoroscope with digital angiography capabilities and ability to
record and recall images
• Fluid-filled or electrical blood pressure monitoring equipment
to obtain a PA pressure measurement during a right heart
catheterization procedure
• Hand injector and radiopaque contrast media for visualization. DO
NOT use an automated injector through the Stability Sheath.
• Patient Monitor
3. Safety Information
Before use of the Cordella Pulmonary Artery Sensor System,
thoroughly read and understand the instructions for use to avoid
potential injury or death.
Warnings
Warnings indicate the
possibility of system damage
or malfunction, delay in receipt
of information to a healthcare
provider, inaccurate readings,
or injury.
Precautions
Precautions indicate the
possibility of system damage,
malfunction, or the delay in
treatment.
3.1 Warnings: Implantation Procedure
• Only trained personnel should use the Cordella Pulmonary Artery Sensor
System.
• The implant procedure must be performed by trained clinical personnel
with the appropriate interventional and surgical skills, including but
not limited to implantable device placement and deployment over a
guidewire and in a location with the infrastructure to support right heart
catheterizations.
• DO NOT reuse, reprocess, or re-sterilize the Cordella Sensor and Delivery
System. The Cordella Sensor and Delivery System are for single use only.
Any reuse, reprocessing, or re-sterilization may influence the structural
integrity of the components of the device and could lead to transmission
of infectious diseases, other types of infections from one patient to
another, as well as many other serious adverse events including but not
limited to injury, illness, or death of the patient.