Chison SonoAir 60 Operation Manual

Digital color doppler ultrasound system
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Digital Color Doppler Ultrasound System
SonoAir 10/ SonoAir 20/ SonoAir 30/
SonoAir 40/ SonoAir 50/ SonoAir 60/
SonoAir 70/ SonoAir 80/ SonoAir 90
Operation Manual
V1.1
Feb.6
th
2024
CHUM SonoAir -001
CHISON Medical Technologies Co., Ltd.
We reserve the rights to make changes to this manual without prior notice.

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Summarization of Contents

Operation Manual
Regulatory Requirement
Formal statement of terms, conditions, and obligations for using the system.
Statement
Formal statement of terms, conditions, and obligations for using the system.
Meaning of the signal words
Explains the meaning of warning words like NOTE, CAUTION, and WARNING.
Important information
Crucial advisories and precautions before operating the ultrasound system.
Chapter 1 Introduction
Provides essential information for safe system operation and general overview.
1.1 System Overview
Provides a general overview of the ultrasound system's purpose and features.
1.2 Contact Information
Details on how to contact CHISON for support, orders, and inquiries.
Chapter 2 System Safety
Discusses measures to ensure the safety of both the operator and patient.
2.1 Safety Overview
Discusses essential measures to ensure the safety of both the operator and the patient.
2.2 Electrical Safety
Covers protection against electric shock and harmful ingress of water.
2.3 Labels
Explains various labels and symbols found on the ultrasound system.
Labels on main unit
Illustrates and describes labels found on the main unit of the ultrasound system.
Labels on transducers
Shows and explains labels specific to the different ultrasound transducers.
2.3.1 Symbols on Label
Explains the meaning of various symbols used on the system's labels.
2.3.2 Other Device Labels
Provides additional information on device labels and their purpose.
2.4 Patient Environmental Devices
Details acceptable and unapproved devices for use in the patient environment.
2.5 Biological Safety
Addresses biological effects and safety guidelines for ultrasound usage.
2.6 Scanning Patients and Education
Guidelines for safe scanning practices and patient education.
2.6.1 Safe Scanning Guidelines
Provides essential guidelines for safe patient scanning procedures.
Chapter 3 Preparing the System for Use
Covers system preparation, site requirements, and specifications.
3.1 Site Requirement
Specifies environmental and electrical requirements for system installation.
3.1.1 Operation Environment Requirement
Details the recommended environmental parameters for operating the system.
3.1.2 Electrical Requirements
Specifies voltage, power input, and battery requirements for the system.
3.2 System Specifications
Outlines the physical and component specifications of the ultrasound system.
3.2.1 Console View
Illustrates the console layout and identifies its ports.
3.2.2 Physical Specification
Lists the physical dimensions and weight of the ultrasound system.
3.2.3 System Components
Lists the standard components included with the SonoAir ultrasound system.
3.2.4 System Configuration
Details the functional configuration of the system across different SonoAir models.
3.2.5 Accessories
Lists and describes system accessories like transducers and adapters.
① Transducers
Introduces the types of transducers available for the ultrasound system.
② AC/DC adapter
Provides specifications for the AC/DC adapter used with the system.
3.3 System Positioning & Transporting
Instructions for safely moving and transporting the ultrasound system.
3.4 Powering the System
Details on connecting power, acclimation, and system power states.
3.4.1 Acclimation Time
Explains the required acclimation time after transporting the unit.
3.4.2 Connecting the Electric Power
Guides on safely connecting the system to AC power.
3.4.3 Power On
Instructions for turning the ultrasound system on.
3.4.4 Power Off
Procedures for properly shutting down the ultrasound system.
3.4.5 Standby
How to put the system into standby mode.
3.5 Probe Installation and Disassembly
Step-by-step guide for installing and removing ultrasound probes.
Chapter 4 Control Panel
Details the functions and layout of the ultrasound system's control panel.
4.1 Overview of Display Area
Identifies and explains the different areas of the ultrasound system's display.
4.2 Start a New Exam
Step-by-step guide for initiating a new patient examination.
4.3 Control Panel Appearance
Visual guide to the layout and appearance of the control panel buttons.
4.4 Function Key Introduction
Explains the function of various keys on the control panel.
Chapter 5 Imaging
Explains imaging modes, controls, and parameter adjustments.
5.1 Select Scan Mode
Instructions on selecting different imaging modes and probes.
5.1.1 The Probe Identification
Explains how the system identifies the inserted probe type.
5.1.2 Mode Selection
Guides on selecting probes and clinical applications before scanning.
5.1.3 B Mode
Basic two-dimensional scanning and diagnosis mode.
5.1.4 2B Mode
Displays two B mode images side-by-side for comparison.
5.1.5 B/M Mode
Combines real-time B mode and M mode imaging.
5.1.6 CFM Mode
Adds color-coded information on fluid motion and direction.
5.1.7 CPA (PD) Mode
Maps Doppler signal strength, regardless of velocity, for flow visualization.
5.1.8 DPD Mode
A mode related to Power Doppler Imaging.
5.1.9 PW Mode
Examines blood flow velocity, direction, and spectral content.
5.2 Functional Description of Parameter Adjustment
Details how to adjust imaging parameters using controls and menus.
5.2.1 Adjust Parameters by Keys on Control Panel
How to adjust image parameters using dedicated control panel keys.
5.2.2 Adjust Parameters by Parameter Control Keys and Menu
Explains parameter adjustments via control keys and system menus.
5.2.2.1 B Image Parameters Adjustment
Detailed adjustment options for B mode image parameters.
5.2.2.2 B Utility Menu
Utility functions for B mode image adjustments like Chroma and 2D Map.
5.2.2.3 B/M Image Parameters Adjustment
Parameter adjustments specific to B/M mode imaging.
5.2.2.4 CFM Image Parameters Adjustment
Parameter adjustments for Color Flow Mapping (CFM) mode.
5.2.2.5 PW Image Parameters Adjustment
Parameter adjustments for Pulsed Wave (PW) Doppler mode.
5.3 After Capturing the Image
Steps for adding annotations and body marks after image capture.
5.3.1 Adding Annotation
Instructions on how to add text or symbols to images.
5.3.1.1 Overview
Explains the purpose and method of adding comments to images.
5.3.1.2 Input and Edit Comments
Detailed steps for inputting and editing text comments on images.
5.4 Image Browse
How to access and manage previously captured images.
5.5 Archive Management
Procedures for searching and managing stored patient information.
5.6 Report
Steps for generating, saving, and printing examination reports.
5.7 DICOM
Configuration and usage of DICOM for data transfer and worklists.
5.7.1 DICOM Worklist
Describes how to use the DICOM worklist for patient data retrieval.
5.7.2 DICOM Storage
Instructions for configuring DICOM storage for images and cine loops.
Chapter 6 Measurement and Calculation
Details various measurement methods and calculations for different imaging modes.
6.1 Keyboard for Measurement
Explains the use of the touchpad and keys for measurements.
Touchpad
Details touchpad functions for cursor movement and measurement adjustments.
ENTER key
Explains the role of the ENTER key in starting and confirming measurements.
UPDATE key
Describes the UPDATE key's use in switching measurement points or axes.
CLEAR key
Function of the CLEAR key for deleting measurement results.
Parameter Control key
How to activate functions using parameter control keys.
6.2 Fast Measurement
Procedures for performing rapid measurements using the MEASURE key.
6.2.1 Enter into Fast Measurement
Steps to initiate the fast measurement mode.
6.2.2 Exit Fast Measurement
How to exit the fast measurement mode.
6.2.3 B Mode Fast Measurement
Detailed measurement methods within B mode.
Distance
Steps for measuring distance in B mode.
Angle
Steps for measuring angles in B mode.
Ratio (Distance)
How to calculate the ratio between two distance measurements.
Area-Trace
Method for measuring area by tracing the perimeter.
Area-Ellipse
Method for measuring area using an ellipse.
Ratio (Area)
How to calculate the ratio between two area measurements.
Volume (3 Distances)
Method for measuring volume using three distances.
Volume (2 Distances)
Method for measuring volume using two distances.
Volume (1 Distance)
Method for measuring volume using a single distance.
Volume (1 Ellipse)
Method for measuring volume using one ellipse.
Volume (1Ellip1Dis)
Method for measuring volume using one ellipse and one distance.
6.2.4 B/M Mode Fast Measurement
Fast measurement procedures for B/M mode.
M Distance
Steps for measuring distance in M mode.
Time
Steps for measuring time intervals in M mode.
Heart Rate
How to measure heart rate from cardiac images.
Velocity
Steps for measuring blood flow velocity.
Other Measurement Items
Refers to other measurement items sharing steps with B mode fast measurement.
6.2.5 PW Mode Fast Measurement
Fast measurement procedures for PW mode.
Peak
How to measure peak values in PW mode.
Auto Trace
Procedure for automatically tracing spectral waveforms in PW mode.
Other Measurement Items
Refers to measurement items shared with B mode fast measurement.
6.3.2 B General Measurement
General measurement options available in B mode.
6.3.3 B Abdomen Measurement
Specific measurement options for abdominal imaging.
6.3.4 B OB Measurement
Measurement options for obstetric (OB) imaging.
6.3.5 B Pediatrics Measurement
Measurement options for pediatric imaging.
6.3.5.1 HIP
Measures fetal hip growth, calculating two angles.
6.3.6 B Vascular Measurement
Measurement options for vascular imaging.
6.3.7 B GYN Measurement
Measurement options for gynecological (GYN) imaging.
6.4 B/M Mode Measurement Package
Details measurement procedures specific to B/M mode.
6.4.1 General Measurement Methods
General measurement methods applicable to B/M mode.
6.4.2 General Measurement in B/M mode
Specific general measurement options for B/M mode.
6.4.3 B/M Cardiology Measurement
Cardiology-specific measurements within B/M mode.
6.4.4 Other Measurement in B/M Mode
Refers to general measurements for other presets in B/M mode.
6.5 PW Mode Measurement Package
Details measurement procedures specific to PW mode.
6.5.1 General Measurement Methods
General measurement methods for PW mode.
StD%
Measures the diameter reduction ratio of a vessel.
StA%
Measures the area reduction ratio of a vessel.
Velocity
How to measure blood flow velocity in PW mode.
Trace (Auto Trace)
Procedure for automatically tracing spectral waveforms in PW mode.
6.5.2 PW General Measurement
General measurement options for PW mode.
6.5.3 PW OB Measurement
OB-specific measurements in PW mode.
6.5.4 PW GYN Measurement
GYN-specific measurements in PW mode.
6.5.5 PW Cardiology Measurement
Cardiology-specific measurements in PW mode.
Chapter 7 Cine-Memory
Explains theory and operation of saving and playing back images in cine memory.
7.1 The Principle of Cine Storage
Explains the concept and mechanism of storing images in cine memory.
7.2 Manual Playback
How to manually play back cine loops using the touchpad.
7.3 Automatic Playback
Steps for initiating and stopping automatic playback of cine loops.
7.4 Loop Range Set
How to define the start and end points for cine loop playback.
7.5 Save and Recall Image
Procedures for saving and retrieving individual images.
7.6 Save and Recall Cine
How to save and recall cine loops.
7.7 Send Image
Options for sending images to external storage or printers.
Chapter 8 Setup
Covers system configuration, measurement setup, and mode settings.
8.1 General Setup
Basic system settings for hospital name, patient format, date/time, and language.
8.1.1 General Interface
Details on configuring general settings like screen saver and export options.
8.1.2 Image & Cine Interface
Settings for screen type, cine storage, and image display options.
8.1.3 Keyboard Interface
Customizing functions for number keys and optional buttons.
8.2 Measurement Setup
Configuration for measurement units, options, and formulas.
8.2.1 General Interface
Setting the display unit for measurement items.
8.2.2 Configuration Interface
Managing measurement menus, adding, modifying, and removing items.
8.2.2.1 Interface Description-Measurement Calculation
Explains the interface for editing and configuring calculation settings.
8.2.2.2 Create Measurement Operation
Steps to create custom measurement operations and formulas.
8.2.2.3 Formula Edit
Interface for editing measurement formulas.
8.2.3 OB Table Interface
Interface for managing OB measurement items and formulas.
8.3 Comment Setup
Customizing text annotations and comment libraries.
8.4 BodyMark Setup
Customizing body mark displays for different examinations.
Edit BodyMark Type
Creating, deleting, and renaming bodymark types.
8.5 Exam Mode Setup
Setting up and configuring exam modes.
8.5.1 Exam Mode Selection Interface
Selecting and organizing exam modes for probes.
8.5.2 Exam Mode Config Interface
Configuring comments, bodymarks, and measurements for exam modes.
8.5.3 Image Freeze Config Interface
Setting image freeze status and auto freeze options.
8.5.4 Scanning Mode Preset Edit
Editing presets for scanning modes.
8.6 Report Setup
Customizing report layout and diagnostic templates.
8.7 DICOM Setup
Configuring DICOM services like storage, worklist, and print.
Chapter 9 System Maintenance
Covers cleaning, maintenance, safety checks, and troubleshooting procedures.
9.1 Cleaning
Procedures for cleaning the main unit, LCD screen, and control panel.
9.1.1 Main unit
Instructions for cleaning the main unit of the ultrasound system.
9.1.2 LCD screen
Guidelines for gently cleaning the LCD display surface.
9.1.3 Control panel
How to clean the control panel buttons and surrounding areas.
9.2 Maintenance
Recommended planned maintenance schedule for the main unit.
9.3 Safety Check
Procedures for periodic safety checks and troubleshooting.
9.4 Troubleshooting
Common malfunctions, their causes, and suggested solutions.
9.5 Service Responsibility
Information on warranty, authorized service, and product lifespan.
Chapter 10 Probes
Covers probe description, care, maintenance, and operation.
10.1 General Description
Introduction to the ultrasound probes and their imaging capabilities.
10.2 Care and Maintenance
Guidelines for inspecting, cleaning, and maintaining ultrasound probes.
10.2.1 Inspecting Probes
How to visually inspect probes for damage before and after use.
10.2.2 Cleaning and Disinfecting
Detailed procedures for cleaning and disinfecting probes.
Definitions
Defines terms related to cleaning and disinfection processes.
Low-Level Disinfection (LLD)
Explains the process of low-level disinfection.
Intermediate-Level Disinfection (ILD)
Explains the process of intermediate-level disinfection.
High-Level Disinfection (HLD)
Explains the process of high-level disinfection.
10.2.3 Probe Safety
Essential safety precautions for handling ultrasound probes.
10.2.3.1 Handling Precaution
General precautions for handling probes to prevent damage and ensure safety.
10.2.3.2 Probe Handling and Infection Control
Measures to prevent disease transmission during probe use.
10.3 Probe Operation Instructions
Instructions for connecting, activating, and operating probes.
10.3.1 Scanning the Patient
Ensures optimal energy transmission using conductive gel during scanning.
10.3.2 Operating Transvaginal probe
Safety instructions for operating transvaginal probes, including cover usage.
Operation Procedure:
Step-by-step guide for correctly applying a condom to a transvaginal probe.
10.3.3 Cleaning and Disinfecting Transvaginal Probe
Recommended procedures for cleaning and disinfecting transvaginal probes.
Cleaning
Instructions for removing coupling gel and washing the transvaginal probe.
Disinfecting
Procedure for disinfecting transvaginal probes using recommended germicides.
Disinfecting Procedure:
Detailed steps for disinfecting transvaginal probes according to manufacturer guidelines.
Appendix A: The Information of EC Representative
Contact details for the authorized representative in the European Community.
Appendix B: Acoustic Output Report Table
Presents acoustic output data for the 7L transducer in B mode.
Appendix D: Measurement Results Summary
Summarizes the useful range and accuracy of various measurement types.
Appendix E: Display Accuracy and Acoustic Measurement Uncertainties
Details the uncertainties associated with display and acoustic measurements.
Appendix F: Transducer Maximum Surface Temperature
Reports maximum surface temperatures for transducers under different conditions.
Appendix G: Pulsed Wave Doppler Velocity Measurement Results Summary
Summarizes velocity measurement results for different probes and modes.
Appendix H: Procedures of setting network sharing
Step-by-step guide for setting up network sharing for the system.

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