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nGEN™ Pump User Manual
8 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.
1. To avoid harm to the patient, use the pump only when the use of irrigation solution is
appropriate for the medical condition of the patient. If it is not known what impact the irrigation
solution might have on the patient, consult with appropriate medical professionals before using
the pump.
2. The pump may be operated in the immediate vicinity of a compatible generator. However, do
not operate the pump in the immediate vicinity of devices that are not approved for
electromagnetic compatibility (EMC) with the pump. If such operation is unavoidable, regularly
monitor the pump and move the pump if it does not function properly.
3. Use only compatible accessories and devices provided by or recommended by Biosense
Webster. If you use accessories or devices that are not compatible, the safety of the pump is not
guaranteed. Do not use settings above the maximum rated voltage for the accessories.
4. Use only the AC adapter provided with the pump. If an incompatible AC adapter is used, the
pump might not function properly.
5. Use only a compatible irrigation tubing set provided by or recommended by Biosense Webster.
If an incompatible irrigation tubing set is used, the pump might not function properly or improper
irrigation might result.
6. 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.
7. The pump, the generator, and all accessories connected to the pump or generator, when
located within the patient area, must comply with IEC/EN 60601-1 and its sub-standards.
8. Do not connect the pump to other infusion systems, including gravity intravenous (IV) infusion
systems.
9. The hospital staff is responsible for ensuring that the pump is functioning properly and that the
irrigation solution and irrigated catheters that are used are compatible with each other. The
pump and the compatible irrigation tubing set are intended for use with a standard irrigation
solution such as a normal isotonic saline solution. The accuracy of the flow rate stated in 12.1,
Specifications may not be maintained if incompatible irrigation solutions and/or incompatible
irrigated catheters are used.
10. Parts of the pump, such as the intravenous (IV) pole clamp, the rotating pump head, and the
door that covers the pump head, are designed for safe operation and must be used with caution.
11. After turning on the pump, wait until the automatic self-test has been successfully completed
before starting the first steps of the procedure on the patient. The self-test helps to detect
problems with the pump before use.
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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