Biosense Webster nGEN User Manual

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nGEN™ Pump

User Manual

EML-1397-01-IFU.02A-EN

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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Page 1 Pump User Manual EML-1397-01-IFU.02A-EN WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use. AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada. Release Date: 2/14/2024...
Page 2: Table Of Contents
Pump User Manual Table of Contents DEVICE DESCRIPTION ........................1 INTENDED PURPOSE ........................1 INDICATIONS ............................. 1 CONTRAINDICATIONS ........................1 PATIENT TARGET GROUP ........................ 1 INTENDED USERS ..........................1 CLINICAL BENEFIT ..........................1 WARNINGS............................2 OVERVIEW OF THE PUMP......................... 4 Definitions of Notes, Cautions, and Warnings ................
Page 3 Pump User Manual 13 SYMBOLS............................25 14 ERRORS AND TROUBLESHOOTING ....................26 15 ADVERSE REACTIONS ........................28 16 WARRANTY............................28 17 ELECTRONIC INSTRUCTIONS FOR USE ..................28 18 APPENDIX ............................29 Page ii WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
Page 4 WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use. AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada. Release Date: 2/14/2024...
Page 5: Device Description
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.
Page 6: Warnings
Pump User Manual Warnings Before using the nGEN™ Pump, completely read and understand this user manual. Also read and understand the instructions for use for the accessories and other devices connected to the pump. The order of the warnings below does not give any indication of their relative importance.
Page 7 Biosense Webster, a service engineer authorized by Biosense Webster, or a service center authorized by Biosense Webster. The warranty is voided if improper modifications or repairs are performed or if the device is not maintained according to the instructions in this user manual.
Page 8: Overview Of The Pump
Use only compatible accessories provided by or recommended by Biosense Webster. If you use accessories that are not compatible, the safety of the pump is not guaranteed. The components listed in Table 1 are provided as part of the initial purchase of the nGEN™ Pump. Table 1 – Components of the Pump...
Page 9: Controls On The Front Of The Pump
Pump User Manual Controls on the Front of the Pump Pump Screen in Ready State Note: The nGEN™ Pump may have an alternate appearance as mentioned in 18, Appendix. Table 3 – Controls on the Front of the Pump On/Off button...
Page 10: Controls On The Back Of The Pump
Pump User Manual Controls on the Back of the Pump Table 4 – Controls on the Back of the Pump Device label COMM: socket for the generator connection cable Service access door. Do not open. Potential equalization pin 24VDC: socket for the AC adapter...
Page 11: Setting Up The Pump
Setting up the Pump Immediately upon receipt, remove the pump and its accessories from the shipping container and inspect for shipping damage or defects. Damage claims can only be filed if Biosense Webster or the shipping agent is notified immediately.
Page 12 COOLFLOW™ Pump adapter (39D-60X) to the Stockert generator and the other end to the nGEN™ Pump cable adapter (M581505). Connect the other end of the nGEN™ Pump cable adapter to the COMM socket on the back of the pump. Contact a Biosense Webster representative for further information.
Page 13: Operating The Pump
Pump User Manual 10 Operating the Pump 10.1 Operational Safety Inspection To ensure the safety of the pump, perform the inspections below before each use. If any problems are discovered, contact Customer Support. (Also see 11.3, Maintenance and Repairs.) ...
Page 14: Explanation Of Buttons And Indicators
Pump User Manual 10.2 Explanation of Buttons and Indicators Table 5 – Explanation of Buttons and Indicators Button or Indicator Image Explanation On/Off button The pump is off. The pump is on. Internal error This indicator (located at the top right corner of the front of the...
Page 15 Pump User Manual Table 5 – Explanation of Buttons and Indicators Button or Indicator Image Explanation Change Low When low flow is inactive, this button has gray arrows on a black background. The background changes to green when the Flow Setting button is pressed to change the low flow setting (See 10.7,...
Page 16: Turning On The Pump
Pump User Manual 10.3 Turning On the Pump Quick Steps 1. Press the On/Off button. Notes  During startup, the pump conducts an automatic self-test of all critical functions, including the motor, bubble sensor, buttons, speaker (long beep), and LEDs. If it detects an internal error, the pump issues a repeating high priority alarm tone, the internal error indicator lights, and an error appears on the screen.
Page 17: Installing The Irrigation Tubing Set
Pump User Manual 10.5 Installing the Irrigation Tubing Set WARNINGS  The irrigation tubing set is sterile and is intended for one-time patient use. To avoid biological contamination and to ensure proper functioning, do not reuse or resterilize the irrigation tubing set.
Page 18: Flushing To Remove Bubbles From The Tubing And Catheter
Pump User Manual Notes  The numbers in the images above correspond to the numbers in 9.3, Controls on the Front of the Pump.  When you close the pump door, the irrigation tubing is compressed to prevent the irrigation solution from flowing freely through the tubing. Be careful not to pinch your fingers or close off the irrigation tubing.
Page 19: Setting The Low And High Flow Rates
Pump User Manual 10.7 Setting the Low and High Flow Rates Quick Steps 1. Press the Change High Flow Setting button (the button changes to ) or press the Change Low Flow Setting blue button (the button changes to green 2.
Page 20: Starting The Irrigation Flow
Pump User Manual 10.8 Starting the Irrigation Flow WARNINGS  To prevent possible occlusion of the holes in the catheter’s tip electrode, start low flow before inserting the catheter into the patient and verify that irrigation solution flows from the tip of the catheter.
Page 21: Stopping The Irrigation Flow
Pump User Manual 10.9 Stopping the Irrigation Flow Quick Steps 1. Press the Stop button to stop the irrigation flow. Notes  The irrigation flow will also stop if you press the On/Off button or open the pump door.
Page 22: Caring For The Pump
Clean and disinfect the pump after each use. Before cleaning the pump, inspect the pump and all connected accessories to ensure that there is no visual damage. Contact Customer Support or your Biosense Webster representative if you identify any problems.
Page 23: Protection Against Damage
Inadequately treated electrical and electronic waste poses environmental and health risks. Follow local regulations for disposal of the pump and its electrical or electronic accessories. To ensure proper disposal, you may contact Customer Support or your Biosense Webster representative regarding return of the pump and its accessories.
Page 24: Technical Data
Pump User Manual 12 Technical Data 12.1 Specifications AC Adapter AC input 100 to 240 VAC Frequency 50 Hz / 60 Hz DC output 24 V, 3 A Flow Accuracy 1 to 5 ml/min -10% to +20% 6 to 39 ml/min...
Page 25: Operating, Storage, And Shipping Specifications
The use of accessories and cables other than those specified in this user manual or specified by Biosense Webster may result in increased emissions or decreased immunity of the pump. The pump is intended for use in the electromagnetic environment specified in Table 7 through Table 10.
Page 26 Pump User Manual Table 8 – Electromagnetic Immunity Immunity Test IEC 60601 Compliance Electromagnetic Environment – Guidance Test Level Level Electrostatic ± 8 kV contact ± 8 kV contact Floors should be wood, concrete, or ceramic discharge (ESD) tile. If floors are covered with synthetic material, ±...
Page 27 Pump User Manual Table 9 – Electromagnetic Immunity Immunity Test IEC 60601 Compliance Electromagnetic Environment – Guidance Test Level Level Conducted RF Portable and mobile RF communications IEC 61000-4-6 equipment should be used no closer to any part of 0.15MHz to...
Page 28 Pump User Manual The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the pump as recommended in Table 10, according to the maximum output power of the communications equipment.
Page 29: Symbols
Pump User Manual 13 Symbols Table 11 – Symbols Symbol Description nGEN™ Pump Medical Device Unique Device Identifier Manufacturer Date of manufacture Packaging unit Consult instructions for use or consult electronic instructions for use Refer to accompanying instructions for use...
Page 30: Errors And Troubleshooting
Pump User Manual Table 11 – Symbols Symbol Description Flow direction Communication connector (to generator, for example) Direct current 24V/1.5A. The center of the connector is positive (+) and the barrel of the plug is negative (-). USB Port A (This symbol is located under the service access door and is not visible to the user.)
Page 31 Pump User Manual Table 13 – External Error Codes Error Code Reason What To Do Incorrect pump speed 1. Press the STOP button to clear the error. was detected 2. Verify that the irrigation tubing is properly seated. 3. Start low flow and verify that the error is resolved.
Page 32: Adverse Reactions
Biosense Webster, a service engineer authorized by Biosense Webster, or a service center authorized by Biosense Webster. The warranty is voided if improper modifications or repairs are performed or if the device is not maintained according to the instructions in this user manual.
Page 33: Appendix
Pump User Manual 18 Appendix The nGEN™ Pump may have the following appearance. All features and functions of the pump shown in 9.3 Controls on the Front of the Pump remain the same as indicated throughout the user manual, except the irrigation tubing will not make an audible snap as indicated in 10.5, Installing the Irrigation Tubing Set.
Page 34 WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use. AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada. Release Date: 2/14/2024...
Page 35 WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use. AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada. Release Date: 2/14/2024...
Page 36 Email: techsupport@its.jnj.com BIOSENSE WEBSTER, the Biosense Webster logo, COOLFLOW, and nGEN are trademarks of Biosense Webster, Inc. The third party trademarks listed herein are trademarks of their respective owners. Patent information is available at www.biosensewebster.com/virtualpatentmarking. © Biosense Webster, Inc. 2017-2024 Revised: 2024-01 WARNING: This is a controlled proprietary and confidential document.