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Device Type | Thrombectomy System |
---|---|
Manufacturer | Boston Scientific |
Model | AngioJet Ultra 5000A |
Power Requirements | 100-240 VAC, 50/60 Hz |
Mechanism of Action | Hydrodynamic thrombectomy |
Catheter Compatibility | AngioJet catheters |
Indication | Used for the removal of thrombus in blood vessels |
Overview of the AngioJet Ultra Console, the main control unit for the thrombectomy system.
Description of the disposable set used for percutaneous thrombus removal.
Specifies the approved uses and clinical applications for the AngioJet system.
Lists critical contraindications and general warnings for safe operation.
Details safety precautions, waste disposal, and potential adverse events.
Environmental conditions for operating, transporting, and storing the device.
Guidance for clinicians and steps to prepare the console for use.
Instructions for loading the pump and priming the catheter.
Procedures for safely disassembling and cleaning the system post-operation.
Explanation of console symbols and guidance on maintenance and troubleshooting.
Definitions of key technical and operational terms used in the manual.
Detailed specifications including dimensions, weight, power, and environmental requirements.
Recommendations for safe use regarding electromagnetic compatibility.
Details the warranty terms and conditions for the AngioJet instrument.