Biosense Webster nGEN - Protection against Damage; Reporting Incidents; Disposal

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nGEN™ Pump User Manual
11.4 Protection Against Damage
In addition to being operated and maintained per the instructions in this user manual, the pump must
also be protected against damage. This includes installing the pump in a safe location and
protecting the pump against moisture, contamination, and contact with explosive or flammable
substances.
Ensure that all cables to devices and accessories are arranged in a way that prevents tripping.
To transport the pump over long distances or to send the pump for service, use the original
packaging. If the original packaging is not available, contact Customer Service or your Biosense
Webster representative for a replacement.
11.5 Reporting Incidents
Per regulation 2017/745/EU on medical devices, if this device is used in the European Union (or in a
country with an identical regime) and a serious incident occurs during the use of this device or as a
result of use of this device, report the incident to the manufacturer and/or its authorized
representative and to your national authority.
11.6 Disposal
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.
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