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nGEN™ Pump User Manual
Table of Contents
1 DEVICE DESCRIPTION ......................................................................................................................1
2 INTENDED PURPOSE ........................................................................................................................1
3 INDICATIONS .....................................................................................................................................1
4 CONTRAINDICATIONS .......................................................................................................................1
5 PATIENT TARGET GROUP ................................................................................................................1
6 INTENDED USERS .............................................................................................................................1
7 CLINICAL BENEFIT............................................................................................................................1
8 WARNINGS.........................................................................................................................................2
9 OVERVIEW OF THE PUMP.................................................................................................................4
9.1 Definitions of Notes, Cautions, and Warnings .............................................................................4
9.2 Components and Accessories ....................................................................................................4
9.3 Controls on the Front of the Pump..............................................................................................5
9.4 Controls on the Back of the Pump ..............................................................................................6
9.5 Setting up the Pump...................................................................................................................7
9.6 Connecting to aGenerator ..........................................................................................................7
10 OPERATING THE PUMP.....................................................................................................................9
10.1 Operational Safety Inspection ....................................................................................................9
10.2 Explanation of Buttons and Indicators....................................................................................... 10
10.3 Turning On the Pump...............................................................................................................12
10.4 Turning Off the Pump...............................................................................................................12
10.5 Installing the Irrigation Tubing Set ............................................................................................ 13
10.6 Flushing to Remove Bubbles from the Tubing and Catheter ..................................................... 14
10.7 Setting the Low and High Flow Rates ....................................................................................... 15
10.8 Starting the Irrigation Flow........................................................................................................ 16
10.9 Stopping the Irrigation Flow......................................................................................................17
10.10 Alarms ..................................................................................................................................... 17
11 CARING FOR THE PUMP .................................................................................................................18
11.1 Cleaning and Disinfecting the Pump.........................................................................................18
11.2 Cleaning the Cords and Connection Cables .............................................................................18
11.3 Maintenance and Repairs ........................................................................................................ 18
11.4 Protection Against Damage......................................................................................................19
11.5 Reporting Incidents .................................................................................................................. 19
11.6 Disposal...................................................................................................................................19
12 TECHNICAL DATA ........................................................................................................................... 20
12.1 Specifications........................................................................................................................... 20
12.2 Operating, Storage, and Shipping Specifications ...................................................................... 21
12.3 EMC Information and Technical Description ............................................................................. 21
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Release Date: 2/14/2024