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General| Category | Medical Equipment |
|---|---|
| Manufacturer | Bayer HealthCare |
| Model | MEDRAD MRXperion |
| MRI Compatibility | Yes |
| Number of Syringes | 2 |
| Pressure Limit | 300 psi |
| Power Requirements | 100-240 VAC, 50/60 Hz |
| Flow Rate | 0.1-10 mL/s |
| Injection Modes | Manual |
| Connectivity | Ethernet |
| Type | Contrast Injector |
Details about system certifications and compliance standards for the MRXperion system.
Specifies the intended use of the MRXperion MR Injection System.
Information on available training resources for the MRXperion system.
Lists known contraindications for the system.
Information regarding sales restrictions in the USA.
Specifies the training requirements for system users.
Disclaimer regarding external wiring, modifications, and accessory use.
Explains symbols related to manufacturing processes.
Explains symbols related to shipping and handling.
Identifies the Notified Body for regulatory compliance.
Details the regulatory classifications of the device.
Explains MR-specific icons and classifications.
Illustrates and explains warning labels and symbols.
Lists critical warnings for safe system operation.
Lists important cautions for safe system operation.
Provides notices to prevent equipment damage.
Overview of the system components and their connections.
Instructions on how to safely move the injection system.
Explains the fundamental principles of fluid delivery by the system.
Overview of the main system display screen.
Detailed description of workstation components.
Explains workstation buttons and icons.
Explains buttons and icons for workstation with pod.
Details the various controls and buttons on the injector head.
Describes the individual components of the injector head.
Details the functionality and use of manual knobs on the injector head.
Explains the lights and indicators on the injector head.
Describes the meaning of injector status lights.
Details the power indicators for the workstation.
Explains the light on the handswitch.
Steps for powering on the MRXperion injection system.
Procedures for safely shutting down the system.
Instructions for performing a hard shutdown.
Steps to restore from injector shutdown.
Steps to restore from system shutdown.
How to enable the system's calculators.
Setup options for eGFR and Weight-Based Dosing calculators.
Guide for configuring the eGFR calculator.
How to enable specific eGFR formulas.
Optional setup for eGFR display output ranges.
Guide for configuring the weight-based dosing calculator.
Instructions on how to use the system calculators.
Step-by-step guide for using the eGFR calculator.
Step-by-step guide for using the weight-based dosing calculator.
How to create new or modify existing injection protocols.
Procedure for saving created or edited protocols.
How to retrieve and use saved protocols.
Steps for preparing the control room environment.
Setting and locking the protocol before syringe installation.
Procedures for preparing the scan room.
Step-by-step guide for installing syringes onto the injector head.
Procedures for filling syringes, either automatically or manually.
How to attach and prime the fluid tubing.
Instructions for connecting the tubing to the patient.
On-screen indicators for adding fluid volume.
Process of arming the injection system.
Steps for arming the injector from the control room.
Steps for arming the injector from the scan room.
Procedure for initiating an optional test injection.
How to start the KVO feature.
Steps to start an injection.
How to pause an injection.
Instructions for aborting an active injection.
How to monitor the progress of an injection.
Information on setting and managing reminders.
Summary screen shown after a successful injection.
Screen displayed when an injection is aborted.
Procedures for exiting the injection complete screen.
Steps for performing subsequent injections.
Instructions for removing used syringes and tubing.
Configuration settings affecting overall system operation.
Setup options for eGFR and Weight-Based Dosing calculators.
Managing and organizing stored protocols.
Configuring settings for fluid delivery.
Accessing help information and system details.
Settings related to Fluid A.
Explains Type 1 system messages.
Explains Type 2 system messages.
Explains Type 3 system messages and error handling.
Procedures for cleaning spills.
Daily cleaning and disinfection procedures.
Steps for daily cleaning of the injector head.
Steps for daily disinfection of the injector head.
Daily inspection and cleaning procedures.
Daily inspection of injector head and mounting.
Daily cleaning and disinfection of the injector head.
How to clean pistons and syringe interface.
Detailed steps for cleaning the pistons.
Detailed steps for cleaning the syringe interface.
How to clean the pedestal and base.
How to clean the workstation screen.
Procedures for monthly inspection and checkout.
Step-by-step guide for monthly system operational checkout.
Annual maintenance and calibration recommendations.
Details on annual system calibration.
Procedures for checking electrical leakage.
Technical specifications for the workstation.
Physical dimensions of the workstation.
Technical specs for workstation with pod.
Dimensions and weight of workstation with pod.
Technical specs for the injector unit.
Physical dimensions of the injector unit.
Ports and connections on the workstation.
Power requirements for the workstation.
Ports and connections on the workstation with pod.
Display connection details for workstation with pod.
Power requirements for workstation with pod.
Dimensions of the scan room unit power supply.
Power requirements for the scan room unit.
Environmental conditions for operation and storage.
Conditions for non-operating periods.
Conditions for system operation.
Safety measures related to electrical shock.
Specifications for electromagnetic interference.
Protection against fluid ingress.
Details on the system's operational modes.
Lists the system's functional capabilities.
Information on heat generated by system components.
Features protecting against infusion errors.
Details on the system's fluid delivery performance.
Performance metrics for system fluid handling.
Factors influencing maximum flow rates.
Data on maximum flow rates with different catheters.
Specifications for forward/reverse controls.
Specifications for the power cable.
Information on ground continuity.
Classification information for the system.
Details on system cybersecurity and network connection.
Software controls for system cybersecurity.
Cybersecurity measures for the workstation.
Risks and considerations for IT network connection.
Lists the main system.
Details the available syringe kits.
Information about the handswitch accessory.
Information about IV poles.
List of available manuals.
Details about the filter kit.
Information on the mobile mount kit.
Details about power cables.
Information on prefilled syringe adapters.
Details about system certifications and compliance standards for the MRXperion system.
Specifies the intended use of the MRXperion MR Injection System.
Information on available training resources for the MRXperion system.
Lists known contraindications for the system.
Information regarding sales restrictions in the USA.
Specifies the training requirements for system users.
Disclaimer regarding external wiring, modifications, and accessory use.
Explains symbols related to manufacturing processes.
Explains symbols related to shipping and handling.
Identifies the Notified Body for regulatory compliance.
Details the regulatory classifications of the device.
Explains MR-specific icons and classifications.
Illustrates and explains warning labels and symbols.
Lists critical warnings for safe system operation.
Lists important cautions for safe system operation.
Provides notices to prevent equipment damage.
Overview of the system components and their connections.
Instructions on how to safely move the injection system.
Explains the fundamental principles of fluid delivery by the system.
Defines how a fluid injection protocol is structured.
Describes the different types of phases in a protocol.
Explains how pressure limits are set and managed.
Details how to set up reminders for protocols.
Procedure for confirming no air in the system.
Option for performing a test injection.
Functionality of the Keep Vein Open feature.
Overview of the Protocol Manager.
How the system manages fluid delivery parameters.
How fluid pressure is managed and limited.
Automatic adjustment of flow rate for pressure control.
How the system responds to blockages.
Features for preventing infusion volume/rate errors.
Features simplifying syringe installation.
Information on the optional informatics platform.
How to configure programming parameters.
Guide to using the pedestal with an IV pole.
Overview of the main system display screen.
Detailed description of workstation components.
Explains workstation buttons and icons.
Explains buttons and icons for workstation with pod.
Details the various controls and buttons on the injector head.
Describes the individual components of the injector head.
Details the functionality and use of manual knobs on the injector head.
Explains the lights and indicators on the injector head.
Describes the meaning of injector status lights.
Details the power indicators for the workstation.
Explains the light on the handswitch.
Steps for powering on the MRXperion injection system.
Procedures for safely shutting down the system.
Instructions for performing a hard shutdown.
Steps to restore from injector shutdown.
Steps to restore from system shutdown.
How to enable the system's calculators.
Setup options for eGFR and Weight-Based Dosing calculators.
Guide for configuring the eGFR calculator.
How to enable specific eGFR formulas.
Optional setup for eGFR display output ranges.
Guide for configuring the weight-based dosing calculator.
Instructions on how to use the system calculators.
Step-by-step guide for using the eGFR calculator.
Step-by-step guide for using the weight-based dosing calculator.
How to create new or modify existing injection protocols.
Procedure for saving created or edited protocols.
How to retrieve and use saved protocols.
Steps for preparing the control room environment.
Setting and locking the protocol before syringe installation.
Procedures for preparing the scan room.
Step-by-step guide for installing syringes onto the injector head.
Procedures for filling syringes, either automatically or manually.
How to attach and prime the fluid tubing.
Instructions for connecting the tubing to the patient.
On-screen indicators for adding fluid volume.
Process of arming the injection system.
Steps for arming the injector from the control room.
Steps for arming the injector from the scan room.
Procedure for initiating an optional test injection.
How to start the KVO feature.
Steps to start an injection.
How to pause an injection.
Instructions for aborting an active injection.
How to monitor the progress of an injection.
Information on setting and managing reminders.
Summary screen shown after a successful injection.
Screen displayed when an injection is aborted.
Procedures for exiting the injection complete screen.
Steps for performing subsequent injections.
Instructions for removing used syringes and tubing.
Configuration settings affecting overall system operation.
List of items configurable within System Setup.
Setup options for eGFR and Weight-Based Dosing calculators.
Steps for deleting a protocol from the manager.
How to reorder protocols in the list.
How to move protocols between regions.
How to hide or show protocol regions.
How to rename a protocol region.
Configuring settings for fluid delivery.
List of configurable items for fluid delivery.
How to set up contrast agent types.
Steps for adding new contrast agent types.
How to edit existing contrast agent types.
Managing contrast types (ordering, deleting).
Accessing help information and system details.
Steps to access the system's help.
Settings related to Fluid A.
Explains Type 1 system messages.
Explains Type 2 system messages.
Explains Type 3 system messages and error handling.
Procedures for cleaning spills.
Steps for cleaning the injector head after spills.
Daily cleaning and disinfection procedures.
Steps for daily cleaning of the injector head.
Steps for daily disinfection of the injector head.
Daily inspection and cleaning procedures.
Daily inspection of injector head and mounting.
Daily cleaning and disinfection of the injector head.
How to clean pistons and syringe interface.
Detailed steps for cleaning the pistons.
Detailed steps for cleaning the syringe interface.
How to clean the pedestal and base.
How to clean the workstation screen.
Procedures for monthly inspection and checkout.
Step-by-step guide for monthly system operational checkout.
Annual maintenance and calibration recommendations.
Details on annual system calibration.
Procedures for checking electrical leakage.
Technical specifications for the workstation.
Physical dimensions of the workstation.
Technical specs for workstation with pod.
Dimensions and weight of workstation with pod.
Technical specs for the injector unit.
Physical dimensions of the injector unit.
Ports and connections on the workstation.
Power requirements for the workstation.
Ports and connections on the workstation with pod.
Display connection details for workstation with pod.
Power requirements for workstation with pod.
Dimensions of the scan room unit power supply.
Power requirements for the scan room unit.
Environmental conditions for operation and storage.
Conditions for non-operating periods.
Conditions for system operation.
Safety measures related to electrical shock.
Specifications for electromagnetic interference.
Protection against fluid ingress.
Details on the system's operational modes.
Lists the system's functional capabilities.
Information on heat generated by system components.
Features protecting against infusion errors.
Details on the system's fluid delivery performance.
Performance metrics for system fluid handling.
Factors influencing maximum flow rates.
Data on maximum flow rates with different catheters.
Specifications for forward/reverse controls.
Specifications for the power cable.
Information on ground continuity.
Classification information for the system.
Details on system cybersecurity and network connection.
Software controls for system cybersecurity.
Cybersecurity measures for the workstation.
Risks and considerations for IT network connection.
Lists the main system.
Details the available syringe kits.
Information about the handswitch accessory.
Information about IV poles.
List of available manuals.
Details about the filter kit.
Information on the mobile mount kit.
Details about power cables.
Information on prefilled syringe adapters.
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