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UPDATED Defibrillator Requirements FDA 510(k) approval Biphasic defibrillation Heart rate alarm If device has wireless capability it must meet the appropriate Federal Information Processing Standard (... UPDATED Defibrillator Requirements FDA 510(k) approval Biphasic defibrillation Heart rate alarm If device has wireless capability it must meet the appropriate Federal Information Processing Standard (FIPS), FIPS 140-2, to ensure compliance to Federal encryption, algorithm, and risk management requirements. Provide certification number with response if applicable. Ability to have step sequence for shocks. Unit displays shocked joule levels and will advance as required Low battery indicator Ability to toggle between manual and automatic external defibrillator (AED) modes for non ACLS trained staff Provides audible alerts for users Pacing capabilities should include fixed and demand Demand pacing mode should be able to recognize intrinsic heart rhythm Pacing rate should range from 40 to at least 170 pulses per minute Parameters to display and monitor: End tidal carbon dioxide (EtCO2) / capnography Pulse oximetry Non-invasive blood pressure Output current for transcutaneous pacing must range between 0 and at least 140 milliamps Printer for code summary should have the ability include but not limited to: ECG waveform Annotated events, like medication administration or defibrillation Time and date Lead configuration must include: I II III aVR aVF aVL Device must have the ability to convert to pediatric Capable of defibrillation completion in less than 2 minutes, including pediatric defibrillation Device must have the ability to alert staff of compression quality to include depth, rate and chest recoil if this is done through an add-on product, please include add-on product in quote. Accessories to be included in purchase: Disposable Pads Paddles Adaptors Non-invasive blood pressure cuff Ability to use Philips bedside monitors accessories, like ECG leads, blood pressure cuff, pulse oximetry and invasive cable monitoring Ability to filter artifact to display underlying rhythm of patient SERVER (if applicable): Must be compatible with Windows 2016 or newer Ability to be virtualized if Cincinnati VAMC chooses to virtualize server Must have RAM provided for optimal performance Must provide anti-virus and malware software