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Summarization of Contents
About This Manual
Target Audience
Identifies the intended users of the manual, primarily trained medical professionals.
Document Conventions & Symbols Glossary
Explains symbols, icons, and text formatting used throughout the manual.
Chapter 1: About the Clarius Ultrasound Scanner
Scanner Description
Provides an overview of the Clarius Ultrasound Scanner's features and capabilities.
Scanner Dimensions
Lists the physical measurements for various Clarius scanner models.
Indications for Use
Details the approved clinical applications and modes for the ultrasound scanner.
Contraindications
Outlines conditions or situations where the scanner should not be used.
Hardware (Warranty & Disposal)
Covers warranty information and proper disposal procedures for the scanner and accessories.
Security (Information, Network, Confidentiality)
Addresses security measures for data, network connections, and information privacy.
System Requirements
Specifies the minimum technical requirements for smart devices used with the Clarius App.
Chapter 2: Using the Clarius Ultrasound Scanner
Downloading the Clarius App
Step-by-step guide for obtaining and installing the Clarius application on smart devices.
Turning the System on & off
Instructions on powering the Clarius Ultrasound Scanner and its associated application on and off.
Inserting & Removing the Battery
Procedures for safely installing and removing the scanner's rechargeable battery.
A Quick Tour Overview (Screens & Workflows)
Introduces the user interface, including scanner pages and exam workflows.
Connecting Your Smart Device
Details the process for establishing wireless connectivity between smart devices and the Clarius Scanner.
Managing Exams
Explains how to manage ultrasound examinations within the Clarius system.
Error Messages & Status Notifications
Describes visual and audible indicators for scanner status and potential issues.
Imaging & Measurement Tools
Covers how to use imaging features and perform measurements on ultrasound scans.
Maintenance & Updates (Hardware & System)
Provides guidance on routine maintenance, software/firmware updates, and system care.
Chapter 3: Accessories
Clarius Cart
Information on the Clarius Cart, its setup, usage, and specifications.
Clarius Battery Charger Hub
Details on the battery charger hub, including charging procedures and specifications.
Clarius Fan & Clip-on
Information on optional accessories like the fan and clip-on adapters for enhanced functionality.
Chapter 4: Cleaning & Disinfecting
Cleaning Procedures (Scanner, Cart, Hub, Fan, Clip-on)
Step-by-step instructions for cleaning the scanner and its various accessories.
Disinfection Procedures (Scanner, Fan, Clip-on)
Guidelines for disinfecting the scanner and its components using appropriate methods.
Spaulding Classification
Explains the classification system for determining appropriate cleaning and disinfection levels.
Chapter 5: Safety
Introduction to Diagnostic Ultrasound Safety
Provides general information on the safe use of diagnostic ultrasound technology.
Product Safety & Warnings
Highlights critical warnings and precautions related to the safe operation of the scanner.
Battery Safety
Details safety precautions and guidelines for handling and charging the scanner's battery.
Cleaning Safety & Disinfectants
Covers safety aspects of cleaning and guidelines for using compatible cleaners and disinfectants.
Clinical Safety Measures (Syringe & Defibrillator)
Addresses specific safety considerations for clinical procedures involving needles and defibrillation.
Biological Safety & Latex Awareness
Discusses biological safety concerns, including latex sensitivity and FDA recommendations.
Ultrasound Bioeffects (Thermal & Mechanical)
Explains the potential thermal and mechanical bioeffects of ultrasound exposure.
ALARA Principle & Application
Details the ALARA principle for minimizing ultrasound exposure and how to apply it.
Output Display & Standards (TI & MI)
Explains thermal (TI) and mechanical (MI) indices displayed by the system.
Electromagnetic Safety & Compatibility
Covers precautions related to electromagnetic interference and system compatibility.
Electrostatic Discharge Precautions
Provides guidance on preventing damage and hazards from electrostatic discharge.
Chapter 6: References
Compliance Statement
Confirms the product's compliance with international and national standards and laws.
Product Serial Number & Specifications
Explains the serial number format and lists system specifications.
Scanner Specifications
Provides detailed specifications for different Clarius scanner models, including size and frequency range.
Regulatory Standards (Biocompatibility, Electrical, etc.)
Lists various standards and regulations the product adheres to, covering biocompatibility, safety, etc.
Risk Management & Validation
Outlines information on risk management, product specifications, design review, and validation processes.
Doppler Sensitivity
Details the Doppler sensitivity performance for different Clarius scanner models.
Acoustic Output Tables
Presents detailed acoustic output data for various scanner models and operating modes.
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