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Mindray Resona I9 User Manual

Mindray Resona I9
475 pages
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Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]

Table of Contents

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Mindray Resona I9 Specifications

General IconGeneral
Power Supply100-240V AC, 50/60Hz
Operating Temperature10°C to 40°C
System TypeUltrasound System
TouchscreenYes
Imaging ModesColor Doppler, Power Doppler
Advanced ImagingV Flow
ConnectivityDICOM, USB, HDMI, Ethernet
ProbesConvex, Linear, Phased Array, Volume
PortabilityCart-based
Storage Temperature-20°C to 55°C
Humidity Range30% to 80% (non-condensing)
Display23.8-inch high-resolution LED monitor
Transducer Ports4

Summary

Operator's Manual

Intellectual Property Statement

Responsibility on the Manufacturer Party

Warranty

Important Information

About This Manual

Notation Conventions

Operator’s Manuals

Hardcopy Manuals

Software Interfaces in this Manual

Conventions

Notification of Adverse Events

Product Differences

1 Safety Precautions

1.1 Safety Classification

Details the safety classifications of the system, including protection against electric shock, water ingress, and flammability.

1.2 Meaning of Signal Words

Explains the meanings of signal words like DANGER, WARNING, CAUTION, and NOTE used for safety instructions.

1.3 Meaning of Safety Symbols

Explains the meaning and usage of safety symbols employed in the manual for user awareness.

1.4 Safety Precautions

Provides essential safety precautions for patient and operator during system operation, covering electrical, mechanical, and general safety aspects.

1.5 Latex Alert

Warns about potential allergic reactions to latex in probe sheaths and provides contact information for CIVCO.

1.6 Warning Labels

Describes the warning labels attached to the system and their meanings to alert users about potential hazards.

2 System Overview

2.1 Intended Use

Specifies the intended patient population and types of examinations the diagnostic ultrasound system is applicable for.

2.2 Contraindication

States that the diagnostic ultrasound system is not intended for ophthalmic use.

2.3 Product Specifications

Details the technical specifications of the system, including power supply and environmental conditions.

2.4 System Configuration

Outlines the standard configuration of the main unit and accessories, and lists available probes.

2.5 Introduction of Each Unit

Provides an overview and function of the various units and components of the ultrasound system.

2.6 Back I/O Panel

Describes the back panel interface, detailing the function of various ports like USB, VGA, HDMI, and network.

2.7 Power Supply Panel

Explains the power supply panel, including auxiliary outputs, AC power inlet, and equipotential terminal.

2.8 Front I/O Panel

Details the front panel interface, including ports for probes, ECG/DC IN, USB, and audio input/output.

2.9 Control Panel

Describes the control panel layout, buttons, knobs, and their functions for system operation.

2.10 Symbols

Lists and explains the various symbols used in the system, including safety, electrical, and port indicators.

3 System Preparation

3.1 Moving/Position the System

Provides instructions and safety precautions for moving and positioning the ultrasound system, with and without central brake.

3.2 Connecting Power Cord & Protective Grounding

Details how to connect the power cord and protective grounding, and information about battery power.

3.3 Monitor Adjustment

Explains how to adjust the monitor's position, brightness, and contrast for optimal viewing.

3.4 Control Panel Position Adjustment

Describes how to adjust the position of the control panel for ergonomic use.

3.5 Connecting/Disconnecting a Probe

Provides instructions for safely connecting and disconnecting ultrasound probes, including warnings.

3.6 Connecting Peripheral Devices

Guides the user on connecting various peripheral devices such as USB devices, footswitches, and printers.

3.7 Basic Screen & Operation

Explains the monitor display layout and basic operations of dialogue boxes and menus.

4 Exam Preparation

4.1 Patient Information

Details how to enter and manage patient information, including new patient registration and exam activation.

4.2 Select Exam Mode and Probe

Guides the user on selecting appropriate exam modes and probes, and switching between them.

4.3 Selecting Imaging Mode

Explains how to select different imaging modes using the control panel buttons.

4.4 Activate& Continue an Exam

Describes how to activate a previously finished exam or continue a paused exam.

4.5 Pause & Continue an Exam

Explains how to pause an exam, save its status, and continue it later or end it.

5 Image Optimization

5.1 Imaging Mode

Explains how to switch between different imaging modes and adjust image parameters on the touch screen.

5.2 B Mode Image Optimizing

Details the B Mode exam protocol and parameters for optimizing image quality.

5.3 M Mode Image Optimization

Explains the M Mode exam operation, parameters, and optimization techniques for improved image quality.

5.4 Color Mode Image Optimization

Covers Color Mode scan parameters and optimization steps to enhance flow imaging.

5.5 Power Mode Image Optimization

Describes Power Mode scan parameters and optimization techniques for visualizing blood flow intensity.

5.6 V Flow

Explains the V Flow mode, its basic operations, parameters, and optimization for visualizing blood flow direction and velocity.

5.7 PW/CW Mode Optimization

Details PW/CW modes, exam operation, parameters, and optimization techniques for spectral display of blood flow.

5.8 Color M Mode (CM)

Explains Color M Mode, its image parameters, and how to enter and exit the mode.

5.9 Free Xros M Mode

Describes Free Xros M mode for analyzing arbitrary parts and directions of 2D images to assess cardiac movements.

5.10 TDI

Introduces TDI mode for low-velocity tissue motion analysis, including its types, exam protocol, and parameters.

5.11 3D/4D

Provides an overview of 3D/4D imaging, terms, and basic procedures for acquiring and viewing images.

5.12 iScape

Explains the iScape panoramic imaging feature, its procedures, capture methods, and image quality evaluation.

5.13 Contrast Imaging

Details contrast imaging, basic procedures, parameter display, and optimization for enhanced visualization of blood flow.

5.14 Elastography

Introduces Elastography, Strain Elastography, its procedures, parameters, and optimization for tissue hardness assessment.

5.15 Stress Echo

Explains Stress Echo feature, overview, acquisition procedures, loop selection, and wall motion scoring.

5.16 Tissue Tracking Quantitative Analysis

Covers Tissue Tracking Quantitative Analysis, its procedures, screen display, and image selection for analysis.

5.17 Fusion Imaging

Explains Ultrasound Fusion Imaging, its overview, magnetic navigator, screen description, and basic procedures.

13 Probes and Biopsy

13.1 Probes

Lists and illustrates various ultrasound probes supported by the system, showing their models.

13.2 Biopsy Guide

Provides comprehensive guidance on performing biopsy procedures, including warnings and safety precautions.

13.3 Needle Navigation Guiding

Explains the needle navigation guiding feature, its procedures, accuracy verification, and screen display.

15 Acoustic Output

15.1 Concerns with Bioeffects

Discusses potential risks of bioeffects from diagnostic ultrasound and concerns regarding advanced applications.

15.2 Prudent Use Statement

Advises on the prudent use of ultrasound, emphasizing minimal exposure for medical benefit and avoiding high levels.

15.3 ALARA Principle (As Low As Reasonably Achievable)

Explains the ALARA principle for controlling ultrasound energy and minimizing bioeffects while acquiring diagnostic information.

15.4 MI/TI Explanation

Provides basic knowledge of Mechanical Index (MI) and Thermal Index (TI) and their relationship to bioeffects.

15.5 Acoustic Power Setting

Details how to adjust acoustic power, default settings, and practical adjustments for optimal imaging and safety.

15.6 Acoustic Power Control

Discusses system controls that affect ultrasound output and quality, categorized into direct and indirect controls.

15.7 Acoustic Output

Explains derated ultrasonic output parameters and FDA maximum acoustic output limits for safety.

15.8 Measurement Uncertainty

Lists the total estimated measurement uncertainties for various acoustic quantities.

15.9 References for Acoustic Power and Safety

Lists references for acoustic power and safety information, including AIUM and IEC standards.

16 EMC Guidance and Manufacturer’s Declaration

TABLE 1 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS

Provides guidance on electromagnetic emissions and compliance levels for the system's RF and harmonic emissions.

TABLE 2 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY

Details electromagnetic immunity requirements and guidance for electrostatic discharge, electrical fast transients, and voltage variations.

TABLE 3 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY

Specifies electromagnetic immunity guidelines related to RF communications equipment and field strengths.

TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM

Provides recommended separation distances for RF communication devices to prevent electromagnetic interference.

17 System Maintenance

17.1 Daily Maintenance

Outlines the daily cleaning procedures for the main unit components, including dust-proof net, display, trackball, and control panel.

17.2 Common inspections

Describes common visual and manual inspections for probes, power cords, plugs, and batteries to ensure proper function.

17.3 System Function Inspection

Details a systematic inspection process for key system functions like B mode, Color mode, Doppler, M mode, and keyboard tests.

17.4 Inspection of Peripherals and Optional Functions

Guides on inspecting peripherals and optional functions like printers, footswitches, barcode scanners, and DICOM/ECG modules.

17.5 Checking Mechanical Safety

Focuses on mechanical safety inspection of key components, including casters, handles, and control panel structures.

Appendix A Barcode Reader

A.1 1-D Barcode Reader

Explains the overview and operation modes of the 1-D barcode reader, including LED indicators and scanning.

A.2 2D Barcode Reader (Take DS4308 as an example)

Details the overview, setup, and settings for the 2D barcode reader, covering cable installation and parameter configuration.

A.3 Settings in Ultrasound System

Describes how to set up the 1D and 2D barcode readers within the ultrasound system's scan code settings.

A.4 Parameter Defaults

Lists the default parameters for 1-D and 2-D barcode readers, including symbologies and settings.

A.5 Maintenance

Provides instructions for cleaning the barcode reader's exit window to maintain scanning accuracy.

Appendix B iWorks (Auto Workflow Protocol)

B.1 Overview

Explains the objective of iWorks for automating ultrasound workflows and reducing user interface steps.

B.2 Normal iWorks Basic Procedure

Guides the user through the basic steps of using a normal iWorks protocol for examinations.

B.3 Screen Display

Illustrates the screen display layout for iWorks, detailing the function of each numbered area.

B.4 View Operation

Describes how to perform view selection, repetition, replacement, and deletion operations within iWorks.

B.5 Manual Examination

Explains how to suspend an iWorks protocol for manual examination and resume it later.

B.6 Insert

Describes the 'Insert' function for adding specialized protocol events and measurements to assist in common pathological states.

B.7 Create

Guides the user on creating custom user-defined iWorks protocols and customizing automated procedures.

B.8 iWorks Settings

Details how to customize protocols and views within the iWorks preset screen for personalized workflows.

Appendix C Wireless LAN

C.1 Use the Wireless feature

Explains how to use the wireless LAN feature, including connecting to networks and entering passwords.

Appendix D Ultrasound Gel Heater

D.1 Overview

Provides a general overview of the ultrasound gel heater and its installation in the heater bracket.

D.2 Structure

Details the structure of the ultrasound gel heater, identifying its components.

D.3 Specifications

Lists the power supply and environmental condition specifications for the ultrasound gel heater.

D.4 Function and Requirement

Describes the function and requirements of the gel heater, including temperature levels and heating time.

D.5 Install the Heater

Provides step-by-step instructions for installing the gel heater and preparing it for use.

Appendix E Electrical Safety Inspection

E.1 Power Cord Plug

Details the electrical safety tests for the power cord plug, including pin condition, plug body, strain relief, and connections.

E.2 Device Enclosure and Accessories

Outlines visual and contextual inspections for the device enclosure and accessories, checking for damage, noises, and smells.

E.3 Device Labeling

Instructs the user to check for the presence and legibility of manufacturer and facility labels, including warning labels.

E.4 Protective Earth Resistance

Explains how to test the protective earth resistance using an analyzer, ensuring it is within specified limits.

E.5 Earth Leakage Test

Describes the procedure for performing Earth Leakage tests under various outlet conditions and lists the applicable limits.

E.6 Enclosure Leakage Test

Details the procedure for performing Enclosure Leakage tests under various outlet conditions and lists the applicable limits.

E.7 Patient Leakage Current

Explains how to measure patient leakage currents between applied parts and mains earth under different conditions.

E.8 Mains on Applied Part Leakage

Describes the Mains on Applied Part test procedure and the associated limits for BF applied parts.

E.9 Patient Auxiliary Current

Explains how to measure patient auxiliary currents between applied part connectors under various outlet conditions.

Appendix F Battery

F.1 Overview

Provides an overview of the built-in battery, its charging behavior, and general usage notes.

F.2 Battery Status Indicator

Explains the battery status indicator icons and their meanings related to battery capacity and charging.

Appendix G List of Vocal Commands

Vocal command

Lists vocal commands and their corresponding operations for controlling the ultrasound system via voice.

Appendix H Operating Environment

Hardware Configuration

Lists the hardware specifications required for the system, including CPU, hard disk, and monitor.

Software Environment

Specifies the software environment requirements, including the operating system.

Network Condition

Details the network requirements, including cable and wireless network standards and security.

Appendix I Indications For Use

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Explains the meaning of indications (N, P, E) used in the document.

Additional comments: Combined modes—B + M, PW + B, Color + B, Power + B, PW + Color + B, Power + PW + B

Lists additional comments regarding combined modes available for the system.

*Intraoperative includes abdominal, thoracic, and vascular

Clarifies that intraoperative applications include abdominal, thoracic, and vascular examinations.

**Small organ-breast, thyroid, testes

Specifies small organ applications covered, including breast, thyroid, and testes.

***Other use includes Urology

Indicates that other uses include urology applications.

****For detection of fluid and pleural motion/sliding

Specifies usage for detecting fluid and pleural motion/sliding.

Note 1: Tissue Harmonic Imaging

Notes regarding Tissue Harmonic Imaging.

Note 2: Smart 3D

Notes regarding Smart 3D imaging.

Note 3: 4D (Real-time 3D)

Notes regarding 4D imaging.

Note 4: iScape View

Notes regarding iScape View.

Note 5: TDI

Notes regarding TDI (Tissue Doppler Imaging).

Note 6: Color M

Notes regarding Color M mode.

Note 7: Strain Elastography

Notes regarding Strain Elastography.

Note 8: Contrast imaging (Contrast agent for LVO)

Notes regarding Contrast imaging for LVO.

Note 9: V Flow

Notes regarding V Flow.

Note10: STE

Notes regarding STE (Sound Touch Elastography).

Note11: STQ

Notes regarding STQ (Sound Touch Quantification).

Note12: Contrast imaging (Contrast agent for Liver)

Notes regarding Contrast imaging for Liver.

Note: The system is not intended for central cardiovascular or central nervous system use.

States that the system is not intended for central cardiovascular or central nervous system use.

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