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nGEN™ Pump User Manual
1 Device Description
The nGEN™ Pump is a peristaltic pump designed for use by electrophysiology laboratory staff in
cardiac electrophysiology procedures. The pump delivers irrigation solution from a connected
irrigation solution bag via a compatible irrigation tubing set to a compatible irrigated catheter.
The pump has an intuitive user interface that allows easy manual control of the pump’s functions.
Alternatively, the pump may be connected to a compatible generator so that the pump’s irrigation
flow rates (high and low) can be controlled by the generator. When the pump is connected to a
generator that is capable of fully controlling the pump, the generator automatically sets the irrigation
flow rate based on the connected catheter type, changes the flow rate when the delivery of energy
starts and stops, and monitors the flow rate.
Only compatible accessories and devices provided by or recommended by Biosense Webster may
be used with the nGEN™ Pump. Prior to using the nGEN™ Pump with a compatible generator,
refer to the generator user manual.
2 Intended Purpose
The nGEN™ Pump is a peristaltic pump intended to work with a compatible irrigation tubing set,
either independently or with a compatible generator, to deliver irrigation solution to compatible
irrigated catheters.
3 Indications
The nGEN™ Pump is a peristaltic pump designed to work with a compatible irrigation tubing set,
either independently or with a compatible generator, to deliver irrigation solution to compatible
irrigated catheters.
4 Contraindications
There are no specific contraindications for the nGEN™ Pump. Refer to the instructions for use for
the catheter for contraindications that are specific to the catheter.
5 Patient Target Group
This pump is used with an irrigated catheter that is targeted at patients who have been diagnosed
with cardiac arrythmias and are undergoing an electrophysiology procedure.
6 Intended Users
The intended users of this pump are appropriately trained personnel in a fully equipped
electrophysiology laboratory.
7 Clinical Benefit
This pump is used with an irrigated catheter to provide irrigation at a selectable flow rate.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
Release Date: 2/14/2024
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