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EDAN M8 Series User Manual

EDAN M8 Series
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文件名称(Document Name):iM8 M8 系列 说明书_英文 中性
文件编号(Number):01.54.456009
版本(Version):1.5
产品型号(Product Model):iM8;iM8A;iM8B;M8;M8A;M8B
项目编码(Project Code):2705I000
签批信息(Signature):
作者(Originator) : 陈 艳娟 (chenyanjuan) 2018-09-21 10:51:26
审核人(Reviewers) : 史 洪华 (shihonghua) 2018-09-25 09:43:23
审核人(Reviewers) : 韩 吉灯 (hanjideng) 2018-09-25 10:07:12
审核人(Reviewers) : 韦 华彪 (weihuabiao) 2018-09-25 16:26:06
审核人(Reviewers) : 王 敏 (wangmin) 2018-09-25 09:21:33
审核人(Reviewers) : 明 镭 (minglei) 2018-09-26 13:31:31
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2018-09-29 15:24:05
批准人(Approvers) : 陈 浩杰 (chenhaojie) 2018-09-29 21:50:28
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

Table of Contents

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EDAN M8 Series Specifications

General IconGeneral
CategoryMeasuring Instruments
TypeMulti-parameter Patient Monitor
Power SupplyAC 100-240V, 50/60Hz
ModelM8 Series
DisplayColor LCD
Display Size12.1 inch
Parameters MeasuredECG, SpO2, NIBP, Respiration, Temperature
ECG3/5-lead ECG
BatteryRechargeable Lithium-ion
ConnectivityEthernet

Summary

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use/Indications for Use

Describes the monitor's purpose, applications, and intended use.

1.2 Safety Guidance

General safety instructions for monitor operation.

1.2.1 Environment

Specifies operating environmental conditions for the monitor.

1.2.2 Power Source Requirements

Details the required power source specifications for the monitor.

1.2.3 Grounding the Monitor

Explains the importance and method of grounding the monitor.

1.2.4 Equipotential Grounding

Details equipotential grounding system requirements for safety.

1.2.5 Condensation

Advises on preventing condensation formation on equipment.

1.2.6 Safety Precautions

Lists critical safety warnings and precautions for operation.

1.2.7 Protecting Personal Information

Outlines measures for protecting patient data and privacy.

1.2.8 Explanation of Symbols on the Monitor

Explains various symbols used on the patient monitor.

Chapter 2 Installation of Monitor

2.1 Opening the Package and Checking

Steps for unpacking and inspecting the monitor and its accessories.

2.2 Connecting the Power Cable

Instructions for correctly connecting the monitor's power cord.

2.3 Powering on the Monitor

Steps to safely power on the patient monitor device.

2.4 Connecting Patient Sensors

How to correctly connect patient sensors to the monitor.

2.5 Checking the Recorder

Procedure to check if the recorder paper is properly installed.

Chapter 3 Introduction

3.1 General Information

Overview of the monitor's features, components, and basic functions.

3.2 Screen Display

Explains the different areas and elements of the monitor's screen display.

3.3 Button Functions

Details the functions of each button and the rotary knob on the monitor.

3.4 Interfaces

Describes the location and types of monitor interfaces and ports.

3.5 Built-in Rechargeable Battery

Information on the monitor's rechargeable battery.

3.5.1 Battery Safety Information

Critical safety warnings and precautions for using the rechargeable battery.

3.5.2 Battery Status on the Main Screen

How to check the battery charge status displayed on the monitor screen.

3.5.3 Checking Battery Performance

Procedure to assess the performance and condition of the rechargeable battery.

3.5.4 Replacing the Battery

Step-by-step instructions for installing or replacing the monitor battery.

3.5.5 Recycling the Battery

Guidance on the proper recycling of used monitor batteries.

3.5.6 Maintaining the Battery

Recommendations for maintaining battery health and lifespan.

3.5.7 Battery Alarm Information

Information regarding technical alarms related to the battery status.

Chapter 4 System Menu

4.1 Patient Setup

How to configure patient information for monitoring.

4.2 Default Setup

Options for restoring factory or user-defined default settings.

4.3 Mark Event

Function to mark significant patient events for later analysis.

4.4 Face Select

Allows users to choose different screen layouts for monitoring.

4.5 Time Setup

Procedure for setting the system date, time, and format.

4.6 Record Setup

Configuration options for the monitor's recording function.

4.7 Module Setup

Enables selection of parameters to be monitored for display efficiency.

4.8 Tracing Waveforms Selection

Defines which waveforms are displayed on the monitor screen.

4.9 Monitor Version

Displays the software version information of the monitor.

4.10 Alarm Volume

Adjusts the volume level for audible alarm prompts.

4.11 Key Volume

Sets the volume for button presses and key sounds.

4.12 Drug Calculation

Provides functions for calculating drug dosages and titration.

4.13 Waveform Demonstration

Enables demonstration mode for machine performance and training.

4.14 Maintenance

Accesses maintenance settings and user-configurable options.

4.15 Data Storing

Manages storing, querying, and deleting patient data via USB.

4.16 Wireless Network with Router (Optional)

Information on configuring the monitor for wireless network connectivity.

Chapter 5 Face Select

5.1 Selecting Operating Screen

How to choose between Standard, Trend, oxyCRG, and Large Font screens.

5.2 Standard Screen

Description of the monitor's basic operating screen layout.

5.3 Trend Screen

Details on viewing trend graphs and their parameters.

5.4 oxyCRG Screen

Explanation of the oxyCRG screen for monitoring neonates.

5.5 Large Font Screen

Describes the display mode with enlarged fonts for better visibility.

Chapter 6 Alarms

6.1 Alarm Modes

General overview of alarm types and behavior.

6.1.1 Alarm Level

Explains the classification of alarms into high, medium, and low levels.

6.1.2 Alarm Modes

Details how alarms are presented: audio, visual, and text descriptions.

6.1.3 Alarm Setup

Configuration options for common and parameter-specific alarms.

6.2 Alarm Cause

Explains the conditions that trigger physiological and technical alarms.

6.3 Audio Alarm Paused

How to temporarily pause audible alarms on the monitor.

6.4 Audio Alarm Off

Procedure to turn off audible alarms for the monitor.

6.5 Alarm Reset

Steps to reset active alarms on the patient monitor.

6.6 Parameter Alarm

Setting alarm limits and status for individual monitored parameters.

6.7 When an Alarm Occurs

Steps to take and information to identify when a patient alarm is triggered.

6.8 Testing Alarms

Procedure for testing the monitor's alarm system functionality.

Chapter 7 Alarm Information

7.1 Physiological Alarm Information

Lists physiological alarms, their causes, and alarm levels.

7.2 Technical Alarm Information

Details technical alarms, their causes, and recommended actions.

7.3 Prompts

Explains system prompt messages indicating ongoing processes.

7.4 Adjustable Range of Alarm Limits

Specifies the adjustable ranges for alarm limits of various parameters.

Chapter 8 Freeze

8.1 General

Overview of the freeze function for reviewing waveforms.

8.2 Entering/Exiting Freeze Status

Steps to activate and deactivate the freeze mode on the monitor.

8.3 FROZEN Menu

Describes the menu options available in freeze status.

8.4 Reviewing Frozen Waveform

How to navigate and review waveforms captured in freeze mode.

Chapter 9 Recording (Optional)

9.1 General Information on Recording

Overview of the thermal dot matrices recorder and its performance.

9.2 Recording Type

Lists the different types of stripe recording modes available.

9.3 Recording Startup

Methods for initiating various recording processes on the monitor.

9.4 Recorder Operations and Status Messages

Proper operation, paper handling, and status messages for the recorder.

9.5 Recorder Alarm Information

Information on technical alarms related to the recorder function.

Chapter 10 Trend and Event

10.1 Trend Graph

How to view and interpret trend graphs of patient parameters.

10.2 Trend Table

Details on displaying and navigating trend data in tabular format.

10.3 NIBP Recall

Procedure to review the latest NIBP measurement data.

10.4 Alarm Event Recall

How to review past alarm events on the monitor.

Chapter 11 Drug Calculation and Titration Table (Optional)

11.1 Drug Calculation

Functionality for calculating drug dosages based on patient parameters.

11.2 Titration Table

Display and operation of the titration table for drug administration.

Chapter 12 Maintenance/Cleaning

12.1 Inspecting

Routine checks for monitor condition, safety, and functionality.

12.2 Maintenance Task and Test Schedule

Schedule and tasks for qualified service professionals.

12.3 Care and Cleaning

Guidelines for maintaining the monitor and its accessories.

12.3.2 Cleaning

Procedures for cleaning monitor components.

12.3.2.1 Cleaning the Monitor

Steps for cleaning the exterior surface of the patient monitor.

12.3.2.2 Cleaning the Reusable Accessories

Procedures for cleaning ECG cables, cuffs, and sensors.

12.3.2.3 Cleaning the Dust-proof Filter Assembly

Instructions for cleaning the monitor's dust-proof filter assembly.

12.3.3 Disinfection

Procedures for disinfecting monitor components to prevent infection.

12.3.3.1 Disinfecting the Monitor

Steps for disinfecting the patient monitor to prevent infection.

12.3.3.2 Disinfecting the Reusable Accessories

Procedures for disinfecting reusable accessories like ECG cables and sensors.

12.3.4 Cleaning and Disinfecting Other Accessories

Guidance for cleaning and disinfecting accessories not detailed elsewhere.

12.4 Replacement of Fuse

Instructions for replacing the monitor's fuse.

12.5 Cleaning Battery and Battery Compartment Cover

How to clean the battery and its compartment cover safely.

Chapter 13 Monitoring ECG/RESP

13.1 Overview

Introduction to ECG monitoring and its capabilities.

13.2 ECG Safety Information

Critical safety warnings and precautions for ECG monitoring.

13.3 Monitoring Procedure

Steps for monitoring ECG and respiration.

13.3.1 Preparation

Steps for preparing the patient and electrodes before ECG monitoring.

13.3.2 Placing Electrodes for ECG Monitoring

Detailed instructions and diagrams for ECG electrode placement.

Recommended ECG Lead Placement for Surgical Patients

Specific ECG lead placement guidelines for surgical procedures.

13.4 ECG Screen Hot Keys

Explains shortcuts for adjusting ECG display settings.

13.5 ECG Menu

Access to ECG configuration settings.

13.5.1 ECG SETUP

Configuration options for ECG alarms, leads, and display.

ST ANALYSE

Functionality for analyzing ST segment deviations.

ARR ANALYSE

Capability for monitoring and analyzing patient arrhythmias.

OTHER SETUP

Accesses additional ECG setup options and configurations.

13.6 ST Segment Monitoring (Optional)

How to enable and configure ST segment monitoring.

13.7 Arr. Monitoring (Optional)

How to enable and configure arrhythmia monitoring analysis.

13.8 Measuring RESP

Process for measuring patient respiration.

13.8.1 How to Measure RESP

Explains the process of measuring patient respiration.

13.8.2 Setting up RESP Measurement

Steps for configuring the monitor for respiration measurement.

13.8.3 Installing Electrode for RESP Measurement

Instructions for placing respiration monitoring electrodes.

13.8.4 RESP SETUP

Configuration options for respiration alarms and display settings.

Chapter 14 Monitoring SpO2

14.1 Overview

Introduction to SpO2 monitoring and its parameters.

14.2 SpO2 Safety Information

Critical safety warnings and precautions for SpO2 monitoring.

14.3 Monitoring Procedure

Steps for attaching the SpO2 sensor and starting monitoring.

14.4 Measurement Limitations

Factors that can affect SpO2 measurement accuracy or cause signal loss.

14.5 Assessing the Validity of a SpO2 Reading

How to check the quality and validity of SpO2 readings.

14.6 SpO2 Alarm Delays

Explains the delays between physiological events and alarm indications.

14.7 Perfusion Index (PI)

Explanation of Perfusion Index as a signal quality indicator.

14.8 SpO2 SETUP

Configuration options for SpO2 alarms, pulse rate, and display settings.

Chapter 15 Monitoring NIBP

15.1 Overview

Introduction to NIBP monitoring using the oscillometric method.

15.2 NIBP Safety Information

Critical safety warnings and precautions for NIBP measurements.

15.3 Measurement Limitations

Conditions that make NIBP measurements impossible or inaccurate.

15.4 Measurement Methods

Describes manual, auto, and sequence methods for NIBP measurement.

15.5 Measurement Procedures

Steps for performing accurate NIBP measurements.

15.6 NIBP SETUP

Configuration options for NIBP alarms, units, and measurement modes.

15.7 Resetting NIBP

Procedure to reset the NIBP system for abnormal performance.

15.8 Calibrating NIBP

Information on NIBP transducer verification and calibration.

15.9 Leak Test

Procedure for performing a leak test on the NIBP airway.

Chapter 16 Monitoring TEMP

16.1 TEMP Monitoring

Introduction to body temperature measurement using thermistor probes.

TEMP Monitoring Setup

Steps to connect and apply temperature probes for monitoring.

16.2 TEMP SETUP

Configuration options for temperature alarms, units, and defaults.

Chapter 17 Monitoring IBP (Optional)

17.1 Introduction

Overview of direct blood pressure monitoring and its parameters.

17.2 IBP Safety Information

Critical safety warnings and precautions for invasive IBP monitoring.

17.3 Monitoring Procedure

Steps for performing invasive blood pressure measurement.

17.4 IBP Menu

Accessing and navigating the IBP setup and calibration menus.

IBP Transducer Zero

Procedure for zeroing the IBP transducer before measurement.

IBP Calibration

Steps for calibrating the IBP transducer for accurate readings.

Chapter 18 Monitoring CO2 (Optional)

18.1 General

Introduction to CO2 monitoring principles and parameters.

18.2 Monitoring Procedure

Steps for monitoring CO2 levels.

18.2.1 Zeroing the sensor

Steps for zero calibrating the CO2 sensor.

18.2.2 Sidestream CO2 Module

Details regarding the Sidestream CO2 module.

18.2.2.1 Measurement Steps

How to perform measurements using the Sidestream CO2 module.

18.2.2.2 Removing Exhaust Gases from the System

Safety procedures for managing exhaust gases from the CO2 system.

18.2.3 Mainstream CO2 Module

Details regarding the Mainstream CO2 module.

18.2.3.1 Measurement Steps

How to perform measurements using the Mainstream CO2 module.

18.3 CO2 SETUP

Configuration options for CO2 alarms, units, and measurement modes.

18.4 Setting CO2 Corrections

How to apply corrections for factors affecting CO2 measurement accuracy.

Chapter 19 Accessories

SpO2 Accessories

Recommended accessories for SpO2 monitoring.

NIBP Accessories

Recommended accessories for NIBP monitoring.

TEMP Accessories

Recommended accessories for temperature monitoring.

ECG Accessories

Recommended accessories for ECG monitoring.

CO2 Accessories

Recommended accessories for CO2 monitoring.

IBP Accessories

Recommended accessories for IBP monitoring.

Other Accessories

List of other recommended accessories for the monitor.

Chapter 20 Warranty and Service

20.1 Warranty

Manufacturer's warranty terms, conditions, and exclusions.

20.2 Contact Information

Contact details for technical support and service inquiries.

Appendix I Specifications

A1.1 Classification

Device classification and compliance with safety standards.

A1.2 Specifications

General specifications overview for the monitor.

A1.2.1 Physical Specifications

Details the physical dimensions, weight, and screen size of monitor models.

A1.2.2 Environment

Specifies the operating and storage temperature and humidity ranges.

A1.2.3 Function Configuration

Lists the standard and optional configuration of monitor functions.

A1.2.4 Display

Information about the monitor's display screen resolution and messages.

A1.2.5 Battery

Specifications for the monitor's rechargeable battery.

A1.2.6 Recorder (Optional)

Technical specifications for the optional recorder module.

A1.2.7 Recall

Specifications for retrieving trend and measurement data.

A1.2.8 ECG

Detailed technical specifications for ECG monitoring.

A1.2.9 RESP

Detailed technical specifications for respiration monitoring.

A1.2.10 NIBP

Detailed technical specifications for NIBP monitoring.

A1.2.11 SpO2

Detailed technical specifications for SpO2 monitoring.

A1.2.12 PR

Detailed technical specifications for Pulse Rate monitoring.

A1.2.13 TEMP

Detailed technical specifications for temperature monitoring.

A1.2.14 IBP (Optional)

Detailed technical specifications for IBP monitoring.

A1.2.15 CO2 (Optional)

Detailed technical specifications for CO2 monitoring.

A1.2.16 Interfaces

Specifications for the monitor's interfaces.

USB Interface

Specifications for the monitor's USB interface.

VGA Interface

Specifications for the monitor's VGA interface.

Network Interface

Specifications for the monitor's network interface.

Appendix II EMC Information

A2.1 Electromagnetic Emissions

Guidance on electromagnetic emissions from the monitor.

A2.2 Electromagnetic Immunity

Guidance on electromagnetic immunity requirements for the monitor.

A2.4 Recommended Separation Distances

Recommended distances for RF equipment to avoid interference.

Appendix III Default Settings

A3.1 Patient Information Default Settings

Default settings for patient information parameters.

A3.2 Alarm Default Settings

Default settings for alarm pause time, audio, sensor, and disconnect alarms.

A3.3 ECG Default Settings

Default settings for ECG alarm switch, level, limits, lead type, and filter.

A3.4 RESP

Default settings for respiration alarms, apnea time, and sweep.

A3.5 SpO2

Default settings for SpO2 alarms, pulse rate, and sweep.

A3.6 PR

Default settings for pulse rate alarms and source.

A3.7 NIBP

Default settings for NIBP alarms, units, and inflation values.

A3.8 TEMP

Default settings for temperature alarms and units.

A3.9 IBP

Default settings for IBP alarms.

A3.10 CO2

Default settings for CO2 alarms, work mode, and apnea time.

Appendix IV Abbreviations

Abbr English Full Name/Description

A comprehensive list of abbreviations used in the manual.

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