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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称：elite V5 V6 V8 说明书_英文
文件编号：01.54.456341
版本：1.9
产品型号：elite V5;elite V6;V8
项目编码(Project Code)：2718I000
签批信息:
作者 : 陈 艳娟 (chenyanjuan)
2018-09-29 16:54:31
审核人 : 史 洪华 (shihonghua)
2018-09-30 15:15:44
审核人 : 韦 华彪 (weihuabiao)
2018-10-08 11:31:01
审核人 : 王 敏 (wangmin)
2018-09-30 13:34:56
审核人 : 王 红春 (wanghongchun)
2018-10-08 12:00:28
批准人 : 夏 欢欢 (xiahuanhuan)
2018-10-09 09:37:31
批准人 : 陈 浩杰 (chenhaojie)
2018-10-08 14:37:00
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)
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Table of Contents
Related Manuals for EDAN elite V8
Summarization of Contents
Chapter 1 Intended Use and Safety Guidance
Intended Use and Indications for Use
Details the intended purpose and indications for the monitor.
Safety Guidance and Personal Information Protection
Provides essential safety instructions, warnings, and guidelines for protecting personal health information.
Explanation of Monitor Symbols
Explains various symbols used in the manual and on the monitor interface.
Chapter 2 Installation Procedures
Initial Inspection and Setup Steps
Steps for inspecting packaging, mounting the monitor, and connecting the power cable.
Monitor Checks and Configuration
Procedures for verifying monitor functionality, checking recorder, and setting date/time.
Regulatory Statements
FCC compliance statements regarding digital devices and RF radiation exposure.
Chapter 3 Basic Monitor Operation
Monitor Overview and Components
Introduces the main unit, modules, and basic components of the monitor.
Navigating the User Interface and Setting Parameters
Explains how to use the monitor's screen, keys, navigate menus, and set parameters.
Operating Modes and Monitor Settings
Describes Demo, Standby, Night, Privacy, NFC modes and changing settings.
Scanner and Screen Calibration
Instructions for using the bar code scanner and calibrating the touch screen.
Chapter 4 Alarm Management
Alarm Categories and Levels
Classifies alarms by type (physiological, technical) and severity (high, medium, low).
Controlling and Testing Alarms
How to set parameter alarms, manage audio, reset, latch, and test alarms.
Network and Sensor Off Alarm Settings
Configuration for network disconnected and sensor off alarm settings.
Chapter 5 Detailed Alarm Information
Physiological and Technical Alarm Details
Lists physiological and technical alarms, their causes, and alarm levels.
Prompts and Adjustable Alarm Limit Ranges
Explains monitor prompts and specifies configurable ranges for various alarm limits.
Chapter 6 Patient Data Management
Admitting and Configuring Patient Information
Steps for admitting a patient, including category and paced status settings.
Quick Admit, Barcode, and Editing Patient Data
Methods for admitting patients quickly and editing existing information.
Central Monitoring System Integration
Connecting the monitor to the central monitoring system for data management.
Chapter 7 User Interface Customization
Display and Waveform Configuration
Setting interface style, display parameters, waveform position, and colors.
Viewing Specific Screens and Bed View
Accessing Trend, OxyCRG, Vital screens and configuring Bed View window.
User and Default Configuration Management
Saving, loading, and managing user configurations and factory defaults.
Chapter 8 ECG Monitoring Procedures
ECG Monitoring Overview and Safety
Introduction to ECG monitoring and essential safety information.
ECG Setup and Display Configuration
Adjusting ECG display size, filters, calculation leads, and menu settings.
ECG Monitoring Procedure and Electrode Placement
Step-by-step monitoring guide, including electrode placement for 3, 5, and 12 leads.
Advanced ECG Analysis Features
Details on 12-lead ECG, ST segment, and arrhythmia analysis.
Chapter 9 Respiration (RESP) Monitoring
RESP Monitoring Overview and Safety
Introduction to respiration monitoring and critical safety precautions.
RESP Setup and Electrode Placement
Guidance on electrode placement, lead selection, and setting up respiration monitoring.
Adjusting RESP Waveform and Apnea Alarm
Configuring respiration waveform display, hold type, and apnea alarm time.
Chapter 10 SpO2 Monitoring Procedures
SpO2 Monitoring Overview and Safety
Introduction to SpO2 monitoring and essential safety information.
SpO2 Measurement Procedures and Limitations
Steps for measuring SpO2, assessing readings, and understanding limitations.
SpO2 Settings and Alarm Management
Configuring alarm delay, pitch tone, sensitivity, SatSeconds, and Perfusion Index.
Chapter 11 Pulse Rate (PR) Monitoring
PR Monitoring Overview
Introduction to pulse rate measurement and its sources.
PR Source, Volume, and Alarm Settings
Configuring PR source, volume, and selecting the active alarm source.
Chapter 12 NIBP Monitoring Procedures
NIBP Monitoring Overview and Safety
Introduction to NIBP measurement and critical safety precautions.
NIBP Measurement Procedures and Limitations
Steps for taking measurements, correcting limb position, and understanding limits.
NIBP System Checks and Settings
Details on NIBP review, resetting, calibration, leakage test, and inflation modes.
Chapter 13 Temperature (TEMP) Monitoring
TEMP Monitoring Overview and Safety
Introduction to temperature measurement and essential safety information.
TEMP Monitoring Setup and Calculations
Instructions for switching probes, setting up monitoring, and calculating temperature differences.
Chapter 14 Invasive Blood Pressure (IBP) Monitoring
IBP Monitoring Overview and Safety
Introduction to IBP monitoring and critical safety precautions.
IBP Monitoring Procedures and Calibration
Steps for monitoring, selecting pressure, zeroing, troubleshooting, and calibration.
Advanced IBP Features and Calculations
Waveform ruler adjustment, overlapping, PAWP, CPP, and PPV measurements.
Chapter 15 CO2 Monitoring Procedures
CO2 Monitoring Overview and Safety
Introduction to CO2 monitoring methods and essential safety information.
CO2 Monitoring Procedures and Sensor Zeroing
Steps for zeroing sensors for different CO2 modules and measurement procedures.
CO2 Settings and Waveform Configuration
Setting CO2 corrections, apnea alarm time, and waveform display.
Chapter 16 Cardiac Output (C.O.) Monitoring
C.O. Monitoring Overview and Safety
Introduction to Cardiac Output monitoring using thermodilution and safety precautions.
C.O. Monitoring Procedure and Preparation
Steps for preparing and performing Cardiac Output measurements.
Blood Temperature Monitoring Function
Functionality for monitoring blood temperature during C.O. measurements.
Chapter 17 Anesthetic Gas (AG) Monitoring
AG Monitoring Overview and Safety
Introduction to AG monitoring modules and comprehensive safety information.
AG Monitoring Procedures and Setup
Steps for using ISA, Dräger, IRMA modules, including checks, zeroing, and cleaning.
AG Settings and Environmental Effects
Configuring apnea alarm, O2 compensation, and understanding humidity effects.
Chapter 18 Bispectral Index (BIS) Monitoring
BIS Monitoring Overview and Safety
Introduction to BIS monitoring and essential safety precautions.
BIS Monitoring Setup and Sensor Checks
Steps for setting up BIS monitoring and performing sensor impedance checks.
BIS Display and Parameter Configuration
Adjusting smoothing rate, secondary parameters, EEG scale, trend length, and filters.
Chapter 19 Respiration Mechanics (RM) Monitoring
RM Monitoring Overview and Safety
Introduction to RM monitoring and essential safety information.
RM Sensor Setup and Calibration
Steps for sensor setup, zero calibration, and purging the system.
RM Configuration and Gas Compensation
Setting apnea alarm, respiration modes, and gas compensation adjustments.
Respiratory Loops Analysis
Viewing, storing, resizing, and changing types of respiratory loops.
Chapter 20 Impedance Cardiography (ICG) Monitoring
ICG Monitoring Overview and Safety
Introduction to ICG monitoring and essential safety precautions.
ICG Measurement Procedure and Sensor Application
Steps for preparing, applying sensors, and setting patient data for ICG.
Selecting Secondary Parameters for ICG
Choosing and displaying secondary parameters for ICG monitoring.
Chapter 21 V-Link Module Interface
V-Link Module Overview and Safety
Introduction to the V-Link module and essential safety information.
Connecting and Managing External Devices
Steps for connecting devices, activating/deactivating module, and handling alarms.
External Device Display and Settings
How to display and configure parameters from NMT, Ventilator, and Anesthetic devices.
Chapter 22 LiDCO Module for Hemodynamic Monitoring
LiDCO Module Overview
Introduction to the LiDCO module for hemodynamic monitoring.
LiDCO Display and Settings Configuration
Configuring parameter display and settings for the LiDCO module.
LiDCO Module Alarm Information
Information regarding alarms generated by the LiDCO module.
Chapter 23 Waveform Freeze Functionality
Entering and Exiting Freeze Status
Steps to activate and deactivate the waveform freeze mode.
Reviewing Frozen Waveforms
How to navigate and examine waveforms captured in freeze status.
Chapter 24 Data Review Functions
Trend Data Review Options
Viewing trend data in graphical and tabular formats.
Reviewing NIBP, Alarm, and Arrhythmia Data
Reviewing NIBP measurements, alarm events, and arrhythmia data.
12-Lead ECG Analysis Review
Accessing and reviewing results from 12-lead ECG analysis.
Chapter 25 Calculation and Titration Features
Drug Calculation and Titration Procedures
Performing drug dose calculations and using titration tables.
Hemodynamic, Oxygenation, Ventilation Calculations
Procedures for calculating hemodynamic, oxygenation, and ventilation parameters.
Renal Function Calculations and Input/Output Parameters
Steps for performing renal function calculations using input and output parameters.
Chapter 26 Recorder Operations
Recorder Performance and Basic Operation
Details on the recorder's performance, starting/stopping, and paper requirements.
Recorder Maintenance and Troubleshooting
Procedures for proper operation, replacing paper, and removing paper jams.
Chapter 27 Patient Report Printing
Printer Configuration Settings
How to configure printer settings before printing patient reports.
Initiating and Halting Report Printing
Steps for starting and stopping the printing of various patient reports.
Chapter 28 Additional Monitor Functions
Nurse Call and Wireless Network Setup
Configuring the nurse call port and connecting to wireless networks.
Data Storage and Management
Options for storing, activating, selecting, reviewing, deleting, and exporting data.
MEWS Score System Functionality
Interface, criteria, methods, results, and trend table for MEWS scoring.
Chapter 29 Battery Management and Safety
Battery Safety Precautions
Essential safety warnings and precautions for using rechargeable batteries.
Battery Status and Performance Checks
Understanding battery indicators, status symbols, and checking performance.
Battery Replacement and Maintenance
Procedures for replacing, recycling, and maintaining batteries.
Chapter 30 Equipment Care and Cleaning
General Cleaning and Disinfection Guidelines
General points and validated cleaning agents for the monitor and accessories.
Cleaning Specific Monitor Components
Detailed cleaning instructions for the monitor, ECG cables, BP cuffs, sensors, and cables.
Disinfection Procedures for Reusable Accessories
Guidelines for high-level and low-level disinfection of monitor components.
Chapter 31 Equipment Maintenance and Testing
Routine Inspection Procedures
Items to be checked during overall monitor inspection and safety checks.
Maintenance Schedule and Tasks
Schedule for maintenance tasks and tests performed by qualified professionals.
Chapter 32 Warranty and Service Information
Warranty Terms and Conditions
Details the product warranty and conditions under which it is void.
Contacting EDAN Service Department
Information on how to contact EDAN for service or technical questions.
Chapter 33 System Accessories Catalog
ECG and SpO2 Monitoring Accessories
Lists ECG cables, electrodes, and SpO2 sensors for various modules.
NIBP, TEMP, and IBP Accessories
Catalog of NIBP cuffs, temperature probes, and IBP transducers.
CO2, C.O., AG, BIS, RM, ICG Accessories
Lists accessories for CO2, Cardiac Output, AG, BIS, RM, and ICG modules.
V-Link, Recording, and Other System Accessories
Lists V-Link modules, recording paper, power cables, batteries, and scanners.
Appendix A Product Specifications
General Product Classifications and Physical Specs
Details product classification, physical dimensions, weight, and compliance standards.
Module and System Specifications
Lists specifications for various modules (NIBP, RM, etc.) and system components.
Environmental, Power, and Display Specifications
Defines environmental operating ranges, power supply, display, and recorder specs.
Parameter Monitoring Specifications (ECG to ICG)
Detailed specifications for ECG, RESP, NIBP, SpO2, TEMP, PR, IBP, CO2, AG, BIS, RM, ICG.
Interface and Connectivity Specifications
Details for Analog Output, Defibrillator Sync, Nurse Call, USB, VGA, DVI, RS232, PAM, Wired Network, V-Link.
Appendix B EMC Information
Electromagnetic Emissions Guidance
Manufacturer's declaration on electromagnetic emission compliance and environment.
Electromagnetic Immunity Guidance
Guidance on electromagnetic immunity levels and recommended separation distances.
Appendix C Default Monitor Settings
Patient Information and Alarm Defaults
Default settings for patient type, pace, alarm pause time, sensor off, and alarm latch.
ECG, RESP, SpO2, PR, NIBP, TEMP Defaults
Default settings for ECG, RESP, SpO2, PR, NIBP, and TEMP parameters.
IBP, CO2, C.O., AG, BIS, RM, ICG, V-Link Defaults
Default settings for IBP, CO2, C.O., AG, BIS, RM, ICG, and V-Link modules.
V/A (Ventilator/Anesthetic) Default Settings
Default settings for Waveform, Loop type, and Ruler configurations.
Appendix D Document Abbreviations
List of Common Abbreviations
Alphabetical listing of abbreviations used in the manual with their full names.
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