Salient Characteristics -- Zenix.docx

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VISN 21 Defibrillator Replacement
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36C26126Q0651
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This is a Brand Name or Equal Worksheet (Salient Characteristics) for a Zenix defibrillator supporting a pre-solicitation sources sought notice. The document details the essential technical and operational specifications that qualify items as acceptable equivalents to the brand name product. The defibrillator must meet specific physical dimensions (9.4 x 10.3 x 8.6 inches, 13.2 pounds with battery), include rechargeable lithium-ion battery with less than 7 seconds ready charge time, and feature integrated Wi-Fi and Bluetooth capability with a 5-year hospital warranty. The device must function as both adult and pediatric automated external defibrillator (AED) with a color LCD 800 x 600 touchscreen, integrated printer, and operational manual in English.

Clinical and operational requirements include high-current rectilinear biphasic waveform defibrillation, dual sensor CPR feedback technology, compatibility with Masimo and Nellcor pulse oximetry, non-invasive blood pressure monitoring, mainstream end-tidal CO2 capability for neonatal, pediatric, and adult patients, and configurable protocols for CPR or shock-first driven methods. The device must include audiovisual CPR coaching with numeric displays of compression depth and rate, ventilation volume indicators, compression artifact filtering algorithms, non-invasive pacing capabilities with 40 millisecond pacing pulse, rapid shock analysis capability (under 5 seconds), shock conversion estimator module, and support for secondary tablet display with data review and playback functionality. The salient characteristics are certified as essential and non-limiting to single manufacturers per VAAR 811.104 and 811.105. This worksheet is associated with the VA's VISN 21 Defibrillator Replacement sources sought notice requiring submissions by May 7, 2026.

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Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0 Brand Name Item:

· Maximum dimensions: 9.4 in x 10.3 in x 8.6 in

· Weight: 13.2 pounds with battery

· Includes alternating current (AC) power cord for use in the United States

· Rechargeable Lithium-ion Battery Pack

· Integrated Wi-Fi and Bluetooth (functionality can also be disabled)

· 5-year hospital warranty

· Ability to function as adult or pediatric automated external defibrillator (AED)

· Operational manual included with each defibrillator which includes manufacturer’s instructions – Language, English Physical/operational features

· Color LCD 800 x 600 touchscreen

· Integrated printer

· Ability to complete self-test directly with specific pre-connected electrodes

· Adult and pediatric dual sensor CPR feedback technology designed to negate “mattress effect”

· Masimo and Nellcor Pulse Oximetry Compatibility

· Non-Invasive Blood Pressure

· For use with adult, pediatric and neonatal patients

· Mainstream End tidal CO2 – Masimo

· Lock screen button

· Ability to operate with touchscreen or rotary dial

· Easily removeable parameter pods designed to decrease downtime for repairs Configurations

· Offers extensive configuration options for customization including the ability to operate and power on either in AED Mode or Manual mode with the ability override and change with just a few button pushes

· Critical care transport (CCT) device (or configuration) offered

· Dedicated, IT configuration menu that is password-protected

· Configurable for either cardiopulmonary resuscitation (CPR) or shock-first driven protocols

· Energy sequences can be configured for single or multiple shocks with fixed or escalating energy levels Batteries

· Rechargeable Lithium lon Battery

· Run-Time and power level indicator

· Designed to automatically re-calibrate, Stores history of use and maintenance

· Less than 7 seconds of ready charge time for a new fully charged battery

Clinical features Defibrillation

· High-current Rectilinear Biphasic Waveform (RBW)

· Configurable option to power on and function as an automated external defibrillator (AED)

· Manual defibrillator to support pediatrics to adults including automatic safety features eliminating the risk of delivering an adult energy dose to a pediatric patient with the use of appropriate pads

· Pediatric specific AED analysis algorithm Electrodes

· Specific adult and pediatric CPR electrodes

· Specific, color-coded packaging for both patient types

· Pediatric pads which clearly differentiate from adult pads Audiovisual CPR Coaching Module

· Numeric display of chest compression depth and rate for adult and pediatric patients

· Visual and audio prompts to coach cardiopulmonary resuscitation (CPR) depth for adult patients

· Visual Release bar prompt to indicate appropriate release off the chest

· Metronome to coach rate for adult and pediatric patients.

· Elapsed time counter (since last detected chest compression) Ventilation Volume Indicators

· Numeric display of tidal volume and ventilation rate delivered by manual oxygen bag

· Visual indicators on screen and cable indicating in or out of range measurements

· Can be used with intubated and non-intubated patients Compression Artifact Filtering

· Algorithms which filters out chest compression artifact during on-going CPR to assist in reducing pause times Non-invasive Pacing Capabilities

· 40 msec pacing pulse

· 4:1 button which allows clinicians to visualize the patient’s intrinsic rhythm without losing capture Rapid Shock Capabilities

· Analyzes ECG rhythm by filtering out chest compression artifact in AED Mode

· Determines shock/no shock decision and enables ability to shock in under [5] seconds Vitals Display for TBI Patient

· Technology indicated to provide graphical trend data for SpO2, Systolic BP (SBP), and EtCO2 as well as ventilation assistance relevant to the management of a TBI patient.

Shock Conversion Estimator (SCE) Module

· Algorithm which measures the probability that a shockable rhythm will be successfully converted by immediate defibrillation

· Utilizes AMSA measure developed by Weil Institute of Critical Care Medicine Secondary Tablet

· Tablet based device and software which provides a secondary display of activity on the defibrillator screen

· Provides customized, real-time views of case data

· Ability to rewind, review, and playback data Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

· The salient characteristics listed above are essential to the Government’s requirements.

· To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.

Name: Daniel Truong Date: 4/16/2026 Title, Service: Biomedical Engineering Telephone Number: (702) 321-1869

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