Edwards EV1000A - User Manual

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Overview

Function Description
Important Technical Specifications
Usage Features
Maintenance Features

The Edwards EV1000 clinical platform is a medical device designed to optimize fluid management in patients through minimally invasive or non-invasive monitoring technologies. The platform is available in two main configurations: the EV1000A system and the EV1000NI system, each with distinct components and power supply configurations.

Function Description:

The primary function of the EV1000 clinical platform is to provide continuous hemodynamic monitoring, aiding clinicians in making informed decisions regarding fluid therapy. This is achieved through the use of specialized sensors and a central processing unit that displays various physiological parameters.

EV1000A System: This configuration utilizes FloTrac sensors for minimally invasive monitoring. It is designed to measure parameters such as cardiac output, cardiac index, stroke volume, stroke volume variation, and systemic vascular resistance, among others. The system provides real-time data to guide fluid resuscitation and optimize patient outcomes in critical care settings.
EV1000NI System: This configuration employs non-invasive ClearSight cuffs as its primary sensor. It is designed for continuous, non-invasive blood pressure and hemodynamic monitoring. Parameters typically measured include continuous blood pressure, cardiac output, stroke volume, and systemic vascular resistance. This system is particularly useful in situations where invasive monitoring is not feasible or desired.
EV1000CS System: This is a combined system that integrates the capabilities of both FloTrac sensors (minimally invasive) and ClearSight cuffs (non-invasive). It offers a comprehensive monitoring solution, allowing clinicians to choose the appropriate monitoring modality based on patient needs and clinical context. The system is powered by the pump unit.

Important Technical Specifications:

While specific detailed technical specifications are not fully enumerated in the provided documents, key aspects related to power and connectivity are highlighted:

Power Supply:
- EV1000A: Utilizes an external power supply, often referred to as a "brick." This external power supply is critical for the device's operation and requires correct orientation to prevent liquid ingress. The AC power cord connects to this external power supply.
- EV1000NI: Powered through a "Pump Unit" component. The AC cord for the EV1000NI inserts horizontally into the unit.
- EV1000CS: Powered by the pump unit. Users of this system are instructed to discard the power supply cord provided with the EV1000A and use only the power supply on the back of the pump unit.
Connectivity: The EV1000CS system, as depicted in an illustration, includes Ethernet ports, indicating network connectivity capabilities for data transfer or integration with hospital information systems.
Sensors:
- EV1000A: FloTrac sensors (minimally invasive).
- EV1000NI: ClearSight cuffs (non-invasive) and a Heart Reference Sensor (HRS).
Components:
- EV1000A: Monitor, Databox, Power adaptor.
- EV1000NI: Monitor, Pump Unit, Pressure Controller, Heart Reference Sensor (HRS).
- EV1000CS: Combines components for both FloTrac and ClearSight functionalities, powered by the pump unit.

Usage Features:

The EV1000 platform is designed for ease of use in clinical environments, with specific instructions for setup and operation to ensure patient safety and device longevity.

Power Supply Orientation (EV1000A): A critical usage feature for the EV1000A is the correct orientation of its external "brick" power supply. It must be positioned with the power connection facing down to prevent liquid ingress, as illustrated by "This End Up" flag labels and diagrams in the operator's manual. Incorrect orientation poses a risk of electrical short circuits and potential fire hazards.
Power Cord Entry Cover (EV1000NI): For the EV1000NI, a power cord entry cover is provided for the pump unit. This cover is designed to reduce the potential for liquid or other conductive contaminants to enter the AC inlet. Users are advised not to remove the power cord from this assembly once installed, except for inspection and cleaning as per policy and the operator's manual.
Fluid Management: A general usage feature across all EV1000 configurations is the strong recommendation to position IV bags and other fluid sources away from AC power connectors to prevent liquid ingress. This is a crucial safety measure to avoid electrical hazards.
Operator's Manual Guidance: The operator's manual serves as a comprehensive guide for proper setup, operation, and maintenance, including warnings about immersion, fluid entry, and cleaning procedures.
Installation Support: Edwards personnel, Technical Service Administrators, or distributors are available to arrange installation of new components like flag labels, power supply covers, boots, and brackets. These installations can also be performed by Biomedical Engineering Staff following provided guidance.

Maintenance Features:

Proper maintenance is essential for the safe and effective operation of the EV1000 clinical platform. The documents highlight several key maintenance aspects, particularly concerning cleaning and preventing liquid ingress.

Cleaning and Disinfection:
- The operator's manual specifies that cleaning should be done by wiping with a damp cloth, and cables should be dried after cleaning. Immersion of the monitor, Databox, or cables in any liquid solution is strictly prohibited.
- It is crucial to ensure that the AC power cord and inlet are clean, dry, and free of contamination by conductive materials prior to use. This applies to both the EV1000A's external power supply and the EV1000NI's pump unit.
- Users are warned against allowing any liquid to come into contact with the power connector, penetrate connectors or openings in the case, or to clean the platform rear panels with excessive liquid.
Contaminant Prevention:
- The design changes, such as the power cord entry cover for the EV1000NI and the emphasis on correct power supply orientation for the EV1000A, are preventative maintenance features aimed at reducing the risk of liquid ingress and contamination.
- Regular checks to ensure the area around power connections is clear of potential contaminants are advised.
Post-Contamination Protocol: In the event of liquid contact with critical components, users are instructed to immediately disconnect power and contact their Biomedical Department or local Edwards Representative, rather than attempting to operate the platform.
Component Updates: Edwards is actively implementing design changes, including "Boot and Bracket" for the EV1000NI, and "Flag Labels" and "Power Cover Adapters" for the EV1000A, to enhance protection against liquid ingress and other contaminants. These updates are part of ongoing maintenance and safety improvements.
Inventory Verification: Customers are requested to verify their inventory and correct setup of the system as part of the acknowledgement process for safety notices, ensuring that all necessary components and safety measures are in place.