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Bayer HealthCare MEDRAD Stellant User Manual

Bayer HealthCare MEDRAD Stellant
104 pages
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Operation Manual
MEDRAD® Stellant CT Injection System
with Certegra® Workstation

Table of Contents

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Bayer HealthCare MEDRAD Stellant Specifications

General IconGeneral
Device TypeContrast Injection System
ApplicationRadiology
ManufacturerBayer HealthCare
ModelStellant
Number of SyringesDual
Flow Rate0.1 to 10 ml/sec
Pressure Limit325 psi
Programmable PhasesYes
Power Requirements100-240 V AC, 50/60 Hz
DisplayTouchscreen
Syringe Capacity200 mL (per syringe)
Syringe Size200 mL
ConnectivityEthernet
CompatibilityCompatible with various CT scanners

Summary

Introduction to the MEDRAD Stellant CT Injection System

Certifications and Standards Compliance

Details the certifications and standards the device complies with, including EMC requirements.

Intended Patient Population and Indications for Use

Specifies the intended patient group and the medical applications for the injection system.

Contraindications and Restricted Sales Information

Lists conditions where the device should not be used and legal restrictions on its sale.

Required Training and Disclaimers

Specifies necessary training and provides disclaimers regarding modifications and external equipment.

Equipotential Connector and Installation Guidance

Explains the function of the Equipotential Connector and provides installation information.

System Symbols and Interface Elements

General Safety and Informational Symbols

Explains various safety, warning, and informational symbols used throughout the manual.

Injector Head Buttons and Icons

Details the various buttons and icons found on the injector head interface.

Workstation Display Buttons and Icons

Explains the buttons and icons visible on the system's display screen.

Base Unit and IV Track System Icons

Describes icons associated with the base unit and the overhead IV track system.

Safety Warnings Precautions and Notices

Critical Safety Warnings

Lists critical safety warnings to prevent serious patient or worker injury or death.

Important Cautions and Notices

Provides important cautions to prevent minor injuries and notices regarding equipment damage.

System Overview and Fluid Delivery Basics

System Diagram and Component Overview

Illustrates the main components of the injection system and their connections.

Fluid Delivery Principles and Protocol Management

Explains fluid delivery basics, protocols, pressure limiting, and protocol manager functions.

Syringe Installation Features

Highlights features designed to simplify syringe loading and setup.

Programming Mode and Informatics

Explains Programming Mode for settings and mentions informatics platform integration.

Using the Pedestal with Integrated IV Pole

Provides instructions for using the system's pedestal and IV pole.

Understanding the Display and Workstation Interface

Home Screen Interface Details

Details the main interface elements of the system's home screen, including indicators and controls.

Workstation Models and Button Descriptions

Describes workstation models and explains their front view buttons and icons.

Workstation with Pod Buttons and Icons

Describes the buttons and icons specific to the workstation model equipped with a pod.

Injector Head and Handswitch Functionality

Injector Head Control and Components

Details the controls and components of the injector head, including heat maintainer and manual knob.

Handswitch Operation and Indicators

Explains the functionality and indicators of the handswitch for starting and stopping injections.

System Powering Up and Shutting Down Procedures

Powering Up the System

Provides step-by-step instructions for powering on the injection system.

System Shutdown Options and Hard Shutdown

Explains normal and hard shutdown procedures and options for the system.

Restoring from Injector Shutdown

Describes how to restore the system after an injector shutdown.

Protocol Management for Injection Procedures

Creating and Editing Injection Protocols

Guides users on creating new or modifying existing injection protocols and phase types.

Saving and Recalling Protocols

Explains the process of saving created or edited protocols and retrieving them.

DualFlow Feature for Simultaneous Delivery

Introduces the DualFlow feature for simultaneous contrast and saline delivery and its programming.

Preparation Steps Before Injection

Control Room Preparation Procedures

Outlines necessary steps for preparing the system in the control room, including protocol selection.

Scan Room Preparation Procedures

Lists essential preparations for the scan room, including fluid detection and tubing setup.

Arming and Injecting Procedures

Volume Indicators and Injector Arming

Explains volume indicators and the process of arming the injector from control or scan rooms.

Injection Initiation and Control Methods

Details starting injections, operator-initiated holds, aborting, and viewing progress.

Completing and Exiting Injection Procedures

Injection Complete Screen and Actions

Details the screen and actions upon completing an injection, including summary and next steps.

Injection Aborted Screen and Exiting

Explains the information displayed when an injection is aborted and how to exit the screen.

Removing and Disposing of Disposable Components

Advanced System Operations and Configuration

System Setup and Configuration Options

Guides on configuring system-wide settings like language, units, and reminders.

P3T Software Functionality Setup

Details the setup for the P3T software, which is separately licensed.

Protocol Manager Operations and Setup

Instructions for managing, organizing, deleting, and renaming protocols and regions.

Fluid Delivery and Informatics Setup

Details configuration options for fluid delivery and refers to informatics setup instructions.

Help System Access and Fluid Selection

Instructions for accessing the help system and selecting fluid values.

System Messages and Error Handling

Injector Head Error Indications

Explains how injector head LEDs indicate errors and how to recover from them.

Error Screen and Recovery Procedures

Describes the error screen, its messages, and procedures for error recovery.

System Tones Identification

Explains the different types of tones the system can emit, general and notification tones.

Cleaning and Maintenance Procedures

Spill Cleanup and Injector Head Cleaning

Procedures for cleaning up spills and daily cleaning of the injector head.

Daily System Inspection and Cleaning Tasks

Daily inspection, cleaning, and disinfection of the injector head and other system parts.

Monthly and Annual Maintenance Checks

Monthly operational checkout and annual maintenance like calibration and leakage checks.

System Reinstallation Guidelines

Provides instructions for moving and reinstalling the system in a different room.

System Options and Accessories

Mounting Options and Extension Cables

Lists available mounting hardware and extension cables for the injector head and workstation.

System Accessories, Manuals, and Disposables

Lists various compatible accessories, manuals, and sterile disposable items for the system.

Technical Specifications of the System Components

Workstation and Workstation with Pod Specifications

Details specifications for workstation and workstation with pod, including dimensions, connections, and power.

Base Unit and Injector Head Specifications

Details specifications for the base unit and injector head, including dimensions and weight.

Environmental and Safety Specifications

Covers environmental conditions, protection against electrical shock, EMI/RFI, and fluid ingress.

Fluid Delivery and Performance Specifications

Details fluid delivery performance, flow rates, and infusion protection features.

Power Cable, Cybersecurity, and Fuse Specifications

Details power cable requirements, cybersecurity controls, network connections, and fuse specifications.

Compliance with IEC 60601-1-2 Standards

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