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EDAN PA Series - User Manual

EDAN PA Series
74 pages
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Table of Contents

Questions and Answers

EDAN PA Series Specifications

General IconGeneral
Model SeriesPA Series
ManufacturerEDAN
Optional ParametersEtCO2, IBP
DisplayColor TFT LCD
ECG3/5-lead ECG
NIBPNIBP (Non-Invasive Blood Pressure)
RESPRespiration
PRPulse Rate
Data StorageTrend data
AlarmVisual and audible alarms
Power SupplyAC Power, Rechargeable Battery
Screen Size12.1 inches
Resolution800 x 600

Summary

About this Manual

Statement

Describes the purpose of the manual and user obligations for safe operation.

Responsibility of the Manufacturer

Defines the manufacturer's responsibility for equipment safety, reliability, and performance.

Product Information

Lists the product name and available models of the system.

Terms Used in this Manual

Explains key concepts and symbols like WARNING, CAUTION, and NOTE.

Chapter 1 Safety Guidance

1.1 Intended Use;Indications for Use

Describes the system's intended purpose and specific applications.

1.2 Contraindications

Lists medical conditions or situations where the system should not be used.

1.3 Safety Precautions

Provides essential warnings and cautions for safe operation of the device.

FCC Statement

1.4 Definitions and Symbols

Definitions and Symbols

Explains key terms and displays symbols used throughout the manual.

Chapter 2 Introduction

Overall Appearance

Illustrates and labels the main components of the system for identification.

CAUTION on Storage Basket Load

A warning regarding the maximum load capacity of the storage basket.

2.1 Main Unit

Front, Left, and Right Views

Details the various interfaces and controls on the front, left, and right sides.

Bottom View and Indicators

Describes the bottom components and explains the system's charge and AC indicators.

2.2 Accessories

Sensor Cable Details

Provides specifications and connection information for the sensor cable.

Vagina Sensor Usage

Instructions for using reusable and disposable vagina sensors.

Rectum Sensor Usage

Instructions for using the reusable rectum sensor.

Stress Probe Usage

Instructions for using the stress probe for pelvic floor muscle measurement.

2.3 Rechargeable Lithium-ion Battery

Battery Replacement and Warnings

Details on how to replace the battery and associated safety warnings.

Battery Status and Charging

Explains how to check battery status and procedures for charging the battery.

Battery Maintenance and Storage

Guidelines for maintaining battery performance and proper storage conditions.

Checking Battery Performance and Recycling

Procedures for checking battery health and instructions for responsible recycling.

Chapter 3 Installation

Package Inspection and AC Power Connection

Steps for unpacking, checking components, and connecting the AC power supply.

System Power On;Off Procedures

Detailed instructions on how to switch the system on and off safely.

Chapter 4 Basic Functions and Operations

Connecting to Patient and Electrode Placement

Guides on connecting patients and proper placement of adhesive electrodes.

Adjusting Current Intensity

Explains how to use control knobs to adjust the current intensity.

Sensor;Probe;Electrodes Detachment

Describes system response and actions when sensors detach during use.

Chapter 5 Software Operation

Starting Up the Software

Initial steps for launching the software and logging in.

Main Interface Overview

Description of the primary screen and navigation to functional modules.

Patient Information Management

Includes adding, searching, and viewing patient records.

Assessment Module Introduction

Overview of the assessment types and how to initiate an assessment.

Assessment Types and Free Training

Assessment Types and Durations

Details the various assessment types and their respective durations.

Free Training Mode

Explanation of the Free Training feature within assessments.

Specific Assessment Procedures

Quick Screening Assessment

Details the phases and procedure for the Quick Screening assessment.

EMG Screening and Assessment

Describes the procedures for EMG Screening and EMG Assessment.

Pressure and Lumbago Assessments

Details the Pressure Assessment and Lumbago Assessment procedures.

Sexual Function and Cough Reflex Assessments

Explains the Sexual Function and Cough Reflex assessment procedures.

Screening Assessment Report

Instructions for viewing, printing, and saving assessment reports.

5.5 Treatment

Defined Protocol Overview

Introduction to predefined treatment protocols including Intelligent and Fixed types.

Intelligent Protocol Configuration

Steps for selecting and generating an Intelligent Protocol based on patient data.

Fixed Protocol Selection

Process for selecting a predefined Fixed Protocol for treatment.

MVC Detection and Protocol Treatment

Explanation of MVC detection and various protocol treatment methods.

Custom Protocol Treatments

Electro-Stim and ETS Custom Protocols

Details on configuring custom Electro-Stim and ETS treatment protocols.

Biostim Feedback and Kegel Custom Protocols

Instructions for setting up custom Biostim Feedback and Kegel protocols.

Scene Training and Breath Relaxation

Guides for Scene Training and Breath Relaxation custom treatment modes.

Game and Dilation Custom Protocols

Details on using custom Game and Dilation treatment protocols.

5.5.2 Custom Treatment

Assembling Custom Treatment Protocols

User guide to assemble and adjust customized protocols based on patient needs.

5.6 Postpartum Rehabilitation

Double Person Mode for General Rehab

Instructions for using the Double Person Mode in general rehabilitation.

Single Person Mode for General Rehab

Instructions for using the Single Person Mode in general rehabilitation.

5.7 Database

Patient Information Management

Details on modifying patient information and patient records.

5.8 Settings

User Settings Configuration

Options for configuring user profiles, hospital name, and application.

Modifying Users and Login Settings

Procedures for editing user information and adjusting login preferences.

General Settings

Covers interface, channel, and other general system settings.

Interface and Channel Settings

Customizing visual elements and configuring sensor channels.

Other Settings and Factory Reset

Includes date format, training time, phase interval, and factory configuration restore.

Protocol Management

Managing treatment protocols, including adding, viewing, and exporting.

Database Backup and Rebuilding

Procedures for backing up, rebuilding, and updating the system database.

Communication Settings

Configuration for WiFi, Bluetooth, and NFC wireless connections.

Chapter 6 Maintenance and Cleaning

General Maintenance and Inspections

Guidelines for system maintenance, including visual and routine inspections.

Daily Maintenance Procedures

Daily tasks for maintaining the workstation and system integrity.

Care and Cleaning Safety Instructions

Essential safety precautions for cleaning reusable and disposable accessories.

General Cleaning Points

General advice and precautions for cleaning the main unit and accessories.

Detailed Cleaning Procedures

Step-by-step instructions for cleaning the main unit and sensors.

Disinfecting Procedures

Methods and disinfectants for cleaning reusable accessories.

After Reprocessing Checks

Checks required after cleaning and disinfecting equipment.

Storage and Transport Guidelines

Recommendations for storing and transporting the product.

Chapter 7 Warranty and Service

Product Warranty Information

Details the terms and conditions of the product warranty.

Contact Information for Support

Provides contact details for service, maintenance, and technical questions.

Appendix 1 Product Specifications

Environmental Specifications

Defines operating and storage conditions like temperature and humidity.

Physical Specifications

Lists dimensions, weight, power supply, and compliance standards.

Performance Specifications

Details the performance parameters for EMG, electrical stimulation, and pressure.

Rechargeable Lithium-ion Battery Specs

Provides specifications for the rechargeable lithium-ion battery.

Appendix 2 Troubleshooting

Trouble with Starting Up

Solutions for issues related to abruptly switching off or failure to start.

USB Device Identification Issues

Troubleshooting steps for when a USB disk or device cannot be identified.

Unstable EMG Signal Solutions

Guides to resolve issues causing unstable EMG signal readings.

Falling Off Issue Solutions

Troubleshooting steps for when abdomen or pelvic channels detach.

Appendix 3 EMC Information

Electromagnetic Emissions

Information regarding the system's electromagnetic emissions compliance.

Electromagnetic Immunity

Guidance on the system's immunity to electromagnetic disturbances.

Voltage Dips and Interruptions

EMC compliance for voltage variations on power supply lines.

RF Immunity and Separation Distances

Guidance on RF immunity and recommended separation distances.

Conducted and Radiated RF Immunity

Specifications for conducted and radiated RF immunity tests.

RF Wireless Communications Equipment Test Specs

Table detailing test specifications for RF wireless communications equipment immunity.

Appendix 4 Ordering Information

Caution on Parts Usage

A warning to use only parts supplied by the manufacturer.

Accessories Part Numbers

Lists part numbers for accessories like sensor cables and probes.

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