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EDAN iM50 User Manual

EDAN iM50
317 pages
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Table of Contents

Questions and Answers:

EDAN iM50 Specifications

General IconGeneral
Display TypeTFT LCD
Resolution800 x 600
ECGYes
RespirationYes
SpO2Yes
NIBPYes
TemperatureYes
Pulse RateYes
Data StorageYes
NetworkingWi-Fi, Ethernet
Display Size10.4 inches
Optional ParametersEtCO2, IBP, Cardiac Output
BatteryRechargeable lithium ion battery
ConnectivityUSB

Summary

About this Manual

Statement

Manual purpose and user compliance, copyright notice, and EDAN's rights.

Responsibility of the Manufacturer

EDAN's responsibility for equipment effects on safety, reliability, and performance.

Terms Used in this Manual

WARNING

Advises against actions or situations that could result in personal injury or death.

CAUTION

Advises against actions or situations that could damage equipment or produce inaccurate data.

NOTE

Provides useful information regarding a function or a procedure.

Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use/Indications for Use

Specifies the intended use of monitors for multiple physiological parameters of adults, pediatrics, and neonates.

Chapter 2 Installation

2.1 Initial Inspection

Check packaging for damage and verify contents after unpacking.

2.2 Mounting the Monitor

Instructions for placing the monitor on a flat surface, bed rail, or wall.

2.3 Connecting the Power Cable

Procedure for connecting the AC power line to the monitor.

2.4 Checking the Monitor

Verify normal monitor start-up, alarm lamps, and alarm sound.

Chapter 3 Basic Operation

3.1 System Components

Overview of the monitor's physical components.

3.1.1 Front View

Identifies and describes the front-facing components of the monitor.

3.1.2 Rear View

Identifies and describes the rear-facing ports and components of the monitor.

3.1.3 Side View

Identifies and describes the side-facing components of the monitor.

3.2 Operating and Navigating

Explains how to interact with the monitor's screen and controls.

3.2.1 Using Keys

Details the different types of keys and their functions on the monitor.

3.3 Operating Mode

Describes the different operating modes available on the monitor.

3.3.1 Demo Mode

Instructions for entering and exiting the demonstration mode.

3.3.2 Standby Mode

Procedure for entering and exiting the standby mode.

3.3.3 Night Mode

Instructions for switching to night mode and its effects on settings.

3.3.4 Privacy Mode

Procedure for activating and exiting privacy mode.

3.4 Changing Monitor Settings

Instructions for customizing various monitor settings.

3.4.1 Adjusting Screen Brightness

Steps to adjust the screen brightness of the monitor.

3.5 Adjusting Volume

Guide to adjusting different volume settings on the monitor.

3.5.1 Adjusting Key Volume

Steps to adjust the volume of key presses and knob rotations.

3.7 Setting Languages

Procedure for changing the monitor's display language.

3.9 Calibrating Screens

Steps for calibrating the touch screen interface of the monitor.

Chapter 4 Networked Monitoring

4.1 Cybersecurity Measures

Measures to protect personal health information and ensure device performance.

4.1.1 Personal Information Safety

Strategies for protecting personal health information and device performance.

4.1.2 Network Security

Security operations for network connections, including password and firewall settings.

4.2 Connecting the Wireless Network

Steps to configure and connect the monitor to a wireless network.

4.3 Network Disconnected Alarms

Configuration of alarms for network disconnection events.

4.4 Connecting the Monitor to MFM-CMS

Procedure for connecting the monitor to the central monitoring system.

Chapter 5 Alarms

5.1 Alarm Category

Classification of alarms into physiological, technical, and prompts.

5.1.1 Physiological Alarms

Alarms triggered when physiological parameters exceed predefined limits.

5.1.2 Technical Alarms

Alarms indicating abnormal technical status of the device.

5.2 Selecting Alarm Tone Type

Options for selecting standard or customized alarm sound types.

5.3 Alarm Levels

Classification of alarms into high, medium, and low severity levels.

5.4 Controlling Alarm

Settings for managing and controlling various alarm functions.

5.4.1 Setting Parameter Alarm

Configuration of individual parameter alarm settings like switch, level, and limit.

5.4.3 Audio Alarm off

Procedure to permanently turn off audible alarms.

5.5 Latching Alarms

Configuration for alarm indications that persist after the condition ends.

Chapter 6 Alarm Information

6.1 Physiological Alarm Information

Details on physiological alarms, their causes, and alarm levels.

6.2 Technical Alarm Information

Details on technical alarms, their causes, and recommended actions.

6.3 Prompts

Information about system prompts indicating monitoring status or functions.

6.4 Adjustable Range of Alarm Limits

Table showing adjustable alarm limit ranges for various parameters.

Chapter 7 Managing Patients

7.1 Confirming a Patient

Procedure for confirming the current patient or admitting a new one.

7.2 Admitting a Patient

Steps for entering patient data for safe and accurate operation.

7.5 Managing Patient Information

Options for editing and obtaining patient information.

Chapter 8 User Interface

8.1 Setting Interface Style

User definable interface settings like waveform sweep and parameter display.

8.2 Selecting Display Parameters

Steps to select and configure displayed parameters.

8.3 Changing Waveform Position

Procedure to exchange the positions of parameter waveforms.

8.4 Changing Interface Layout

Options to customize screen layout, waveform display, and control bar.

8.5 Viewing Trend Screen

Instructions to access and configure the trend screen.

8.6 Viewing OxyCRG Screen

Guide to view and review the OxyCRG data.

8.7 Viewing Large Font Screen

Procedure to open and view the large font display screen.

8.8 Viewing the Vital Screen

Instructions to access and view the vital signs screen.

8.9 Viewing the Bed View Window

Functionality for viewing other beds' information on the network.

Chapter 9 Monitoring ECG

9.1 Overview

Introduction to ECG monitoring, waveforms, and numerics.

9.2 ECG Safety Information

Important safety precautions for ECG monitoring.

9.3 ECG Display

Information on ECG waveform display and its elements.

9.3.1 Changing the Size of the ECG Wave

Steps to adjust the size of the ECG waveform display.

9.3.2 Changing the ECG Filter Settings

Guide to changing ECG filter settings for wave smoothing.

9.4 Selecting Calculation Lead

Procedure for selecting the appropriate lead for ECG calculation.

9.5 Monitoring Procedure

Steps for setting up and performing ECG monitoring.

9.5.1 Preparation

Skin preparation techniques for optimal electrode contact.

9.5.2 Connecting ECG Cables

Instructions for connecting ECG cables and electrodes to the patient.

9.5.4 Installing Electrodes

Table and diagrams for correct electrode placement.

9.6 ECG Menu Setup

Navigating the ECG menu for various settings.

9.6.1 Setting Alarm Source

Procedure to change the active alarm source for ECG parameters.

9.6.2 Setting Beat Source

Options for setting the beat source for HR and PR.

9.6.3 Smart Lead Off

Functionality to automatically switch leads when signal is lost.

9.6.4 ECG Screen Layout

Options for screen layout based on electrode type.

9.6.5 Setting Pace Status

Correctly setting the paced status for ECG monitoring.

9.7 12-Lead ECG Monitoring

Information on performing 12-lead ECG monitoring.

9.7.1 Activating 6/10 Electrodes ECG Monitoring

Procedure to activate 6/10 electrodes ECG monitoring function.

9.7.2 Analysis Function

Enables automatic analysis of ECG data.

9.8 ST Segment Monitoring

Analysis of ST segment elevations and depressions.

9.8.1 Setting ST Analysis

Procedure to change ST analysis settings.

9.9 Arrhythmia Monitoring

Monitoring and analysis of cardiac arrhythmias.

9.9.1 Arrhythmia Analysis

Algorithm for detecting heart rate and ventricular rhythm changes.

9.10 QT Analysis

Analysis of QT interval to detect extended QT interval syndrome.

9.10.1 Measurement Limitations

Factors affecting QT analysis accuracy.

Chapter 10 Monitoring RESP

10.1 Overview

Principle of respiration measurement using thoracic impedance.

10.2 RESP Safety Information

Important safety precautions for respiration monitoring.

10.3 Electrode Placement for Monitoring RESP

Proper patient skin preparation for electrode placement.

10.10 Changing the Apnea Alarm Time

Setting the time limit for apnea alarm detection.

Chapter 11 Monitoring SpO2

11.1 Overview

Measurement of arterial blood oxygen saturation and pulse rate.

11.2 SpO2 Safety Information

Critical safety precautions for SpO2 sensor use.

11.4 Measurement Limitations

Conditions that can affect SpO2 measurements or cause pulse signal loss.

11.5 Assessing the Validity of a SpO2 Reading

Methods to assess sensor function and validity of SpO2 readings.

11.6 SpO2 Alarm Delay

Understanding the delay between physiological events and alarm indications.

11.8 Measuring SpO2 and NIBP Simultaneously

Procedure for simultaneous SpO2 and NIBP measurements.

11.11 SatSeconds Alarm Management*

Management of SpO2 alarms using SatSeconds technique.

11.11.1 Describing SatSeconds

Explanation of the SatSeconds calculation for alarm triggering.

Chapter 12 Monitoring PR

12.1 Overview

Measurement of arterial pulsations in beats per minute.

12.4 Selecting the Active Alarm Source

Setting HR or PR as the active alarm source to avoid simultaneous alarms.

Chapter 13 Monitoring NIBP

13.1 Overview

Monitor's oscillometric method for NIBP measurement.

13.2 NIBP Safety Information

Critical safety precautions for NIBP measurement.

13.3 Measurement Limitations

Conditions where NIBP measurement is impossible or inaccurate.

13.4 Measurement Methods

Details on manual, auto, continuous, and sequence measurement methods.

13.5 Measurement Procedures

Steps for obtaining accurate NIBP measurements.

13.5.1 Operation Prompts

Guides for manual, automatic, continuous, and sequence measurements.

13.6 NIBP Multi-Review Window

Setting the display of NIBP measurements.

13.9 Leakage Test

Procedure to test air tightness of NIBP pump, valve, and trachea.

Chapter 14 Monitoring TEMP

14.1 Overview

Measurement of body temperature using thermistor probes.

14.2 TEMP Safety Information

Important safety precautions for temperature monitoring.

14.3 Selecting TEMP Sensor Type

Choosing the temperature sensor type for signal source.

14.5 TEMP Monitoring Setup

Steps for setting up temperature monitoring.

14.6 Selecting a Temperature for Monitoring

Selecting temperature labels based on measurement site.

Chapter 15 Monitoring Quick TEMP

15.1 Overview

Establishing thermal balance for quick temperature measurement.

15.2 Quick TEMP Safety Information

Critical safety precautions for quick temperature measurements.

15.3 Measuring Procedure

Steps for performing oral, rectal, and axillary temperature measurements.

15.3.1 Measurement for Oral Temperature

Detailed procedure for measuring oral temperature.

Chapter 16 Monitoring IBP

16.1 Overview

Measurement of direct blood pressure via catheter.

16.2 IBP Safety Information

Important safety precautions for invasive blood pressure monitoring.

16.3 Monitoring Procedures

Preparatory steps for invasive blood pressure measurement.

16.3.1 Selecting a Pressure for Monitoring

Choosing the pressure label for monitoring.

16.3.2 Zeroing the Pressure Transducer

Procedure to zero the pressure transducer for accurate readings.

16.4 Changing the IBP Waveform Ruler

Adjusting the top, middle, or bottom rulers for IBP waveforms.

16.6 Measuring PAWP

Procedure for measuring Pulmonary Artery Wedge Pressure.

16.7 Calculating CPP

Calculation of Cerebral Perfusion Pressure (CPP).

Chapter 17 Monitoring CO2

17.1 Overview

Methods for CO2 monitoring: sidestream and mainstream.

17.2 CO2 Safety Information

Important safety precautions for CO2 monitoring.

17.3 Monitoring Procedures

Steps for performing CO2 monitoring.

17.3.1 Zeroing the sensor

Procedure for zeroing the CO2 sensor.

17.3.2 Sidestream CO2 Module

Measurement steps for sidestream CO2 modules.

17.4 Setting CO2 Corrections

Adjusting CO2 measurement based on temperature and gas concentrations.

17.5 Setting Apnea Alarm Time

Determining the time limit for apnea alarms.

17.7 Intubation Mode

Mode to eliminate unnecessary alarms during CO2 monitoring.

Chapter 18 Monitoring C.O.

18.1 Overview

Measurement of cardiac output using Thermodilution method.

18.2 C.O. Safety Information

Important safety precautions for cardiac output monitoring.

18.3 C.O. Monitoring

Steps for preparing and performing cardiac output measurement.

Preparing Measurement

Steps to prepare for cardiac output measurement.

Chapter 19 Monitoring AG

19.1 Overview

Monitoring anesthetic gases with various analyzers.

19.2 Safety Information

General safety information for AG monitoring modules.

19.2.1 Safety Information for G7 Module

Specific safety precautions for the G7 module.

19.2.2 Safety Information for Masimo ISA Analyzer

Specific safety precautions for the Masimo ISA analyzer.

19.2.3 Safety Information for Dräger Minimodule

Specific safety precautions for the Dräger Minimodule.

19.2.4 Safety Information for Masimo IRMA Module

Specific safety precautions for the Masimo IRMA module.

19.3 Monitoring Steps

Procedures for monitoring anesthetic gases.

19.3.1 Monitoring Steps for G7 Module

Steps for monitoring anesthetic gases with the G7 module.

19.3.2 Monitoring Steps for Masimo ISA Module

Steps for monitoring anesthetic gases with the Masimo ISA module.

Chapter 20 Freeze

20.1 Entering/Exiting Freeze Status

Procedures for entering and exiting the waveform freeze status.

20.1.1 Entering Freeze Status

Steps to activate the freeze status on any operating screen.

20.2 Reviewing Frozen Waveform

How to review frozen waveforms using the freeze menu.

Chapter 21 Review

21.1 Trend Graph Review

Instructions to review trend data in graph format.

21.2 Trend Table Review

Instructions to review trend data in table format.

21.3 NIBP Review

Procedure to review NIBP measurement data.

21.4 Alarm Review

Instructions to review alarm events.

21.6 12-lead Analysis Review

Procedure to review the results of 12-lead ECG analysis.

21.7 ST Segment Review

Procedure to review ST segment analysis results.

Chapter 22 Calculation

22.1 Drug Calculation

Performing drug dosage calculations and using the titration table.

22.1.1 Calculation Procedures

Steps for performing drug calculations.

22.2 Hemodynamic Calculation

Calculations related to hemodynamic parameters.

22.2.1 Calculation Procedure

Steps for performing hemodynamic calculations.

22.3 Oxygenation Calculation

Calculations related to patient oxygenation.

22.3.1 Calculation Procedure

Steps for performing oxygenation calculations.

22.4 Ventilation Calculation

Calculations related to patient ventilation.

22.4.1 Calculation Procedure

Steps for performing ventilation calculations.

22.5 Renal Function Calculation

Calculations related to patient renal function.

22.5.1 Calculation Procedure

Steps for performing renal function calculations.

Chapter 23 Warning-Score System

23.1 Warning-Score Interface

Accessing and navigating the NEWS and MEWS sub-interfaces.

23.2 Warning-Score Method

Selection between score calculator and auto score methods.

23.3 Warning-Score Criteria

Criteria for calculating NEWS and MEWS scores.

23.4 Warning-Score Result

Interpreting warning-score results and severity levels.

Chapter 24 Recording

24.1 Performance of the Recorder

Specifications and features of the built-in recorder.

24.2 Starting and Stopping Recording

Procedures for starting and stopping various recording types.

24.3 Recorder Operations and Status Messages

Information on recorder operations and status messages.

24.3.1 Record Paper Requirement

Details on the type of record paper required for the recorder.

24.3.5 Removing Paper Jam

Steps to remove a paper jam from the recorder.

Chapter 25 Printing Patient Reports

25.1 Printer Settings

Configuring printer settings for patient reports.

25.2 Starting and Stopping Report Printing

Procedure to print various types of patient reports.

Chapter 26 Other Functions

26.1 Nurse Call

Activating and using the nurse call function.

26.3 Storing Data in the Storage Device

Managing data storage on internal and removable devices.

26.3.1 Data Stored in the Storage Device

Information on the types of data stored in the device.

26.3.2 Activating/ Deactivating Data Storing

Enabling or disabling the data storing function.

26.3.3 Selecting a Storage Device

Configuring the storage device for data saving.

26.3.7 Formatting the Internal Storage Device

Procedure for formatting the internal storage device.

26.3.8 Ejecting a Removable Device

Steps to safely uninstall a removable storage device.

Chapter 27 Using Battery

27.1 Battery Safety Information

Essential safety precautions for handling rechargeable lithium-ion batteries.

27.2 Battery Power Indicator

Explanation of the battery power indicator lights.

27.3 Battery Status on the Main Screen

Symbols indicating battery status and remaining power.

27.5 Replacing the Battery

Procedure for installing or replacing the monitor battery.

27.7 Maintaining the Battery

Recommendations for maintaining battery health and useful life.

Chapter 28 Care and Cleaning

28.1 General Points

General guidelines for keeping the monitor and accessories clean.

28.2 Cleaning

Cleaning procedures for the device and accessories after patient contact.

28.2.1 Cleaning the Monitor

Steps for surface cleaning the monitor's exterior and screen.

28.2.2 Cleaning the Reusable Accessories

Cleaning instructions for reusable accessories like ECG cables and BP cuffs.

28.3 Disinfection

High and low-level disinfection procedures for device components.

28.3.1 Disinfecting the Monitor

Steps for disinfecting the monitor's exterior and display screen.

Chapter 29 Maintenance

29.1 Inspecting

Overall checks and safety inspections performed by qualified personnel.

29.2 Maintenance Task and Test Schedule

Schedule for maintenance and testing tasks, performed by EDAN-qualified professionals.

Chapter 30 Warranty and Service

30.1 Warranty

EDAN's warranty terms and conditions, including voiding clauses.

30.2 Contact Information

Contact details for maintenance, technical specifications, or malfunctions.

Chapter 31 Accessories

31.1 ECG Accessories

List of available ECG accessories with part numbers.

31.2 SpO2 Accessories

List of available SpO2 accessories with part numbers.

31.3 NIBP Accessories

List of available NIBP accessories with part numbers.

31.4 TEMP Accessories

List of available temperature accessories with part numbers.

31.5 Quick Temp Accessories*

List of quick temp accessories, applicable to iM50 and M50.

31.8 C.O. Accessories*

List of cardiac output accessories, not applicable to iM50 or M50.

31.9 AG Accessories*

List of anesthetic gas accessories, applicable to specific modules.

A Product Specification

A.1 Classification

Classification of the equipment based on electroshock protection and ingress protection.

A.2 Physical Specifications

Details on product size, weight, and environmental specifications.

A.2.1 Size and Weight

Specifications for the size and weight of different monitor models.

A.2.2 Environment Specification

Operating and storage temperature and humidity ranges.

A.2.3 Display

Specifications for the monitor's display screen and messages.

A.2.4 Battery Specification

Details on battery operating time and specifications.

A.2.6 Data Management

Information on data review and storage capacities.

A.3 Wi-Fi

Specifications for the wireless network connectivity.

A.3.1 Wi-Fi Technical Specifications

Technical details of the Wi-Fi module, including IEEE standards and frequency.

A.4 ECG

Technical specifications for ECG monitoring.

A.5 RESP

Technical specifications for respiration monitoring.

A.6 NIBP

Technical specifications for non-invasive blood pressure monitoring.

A.7 SpO2

Technical specifications for SpO2 monitoring.

A.8 PR

Technical specifications for pulse rate monitoring.

A.9 TEMP

Technical specifications for temperature monitoring.

A.10 Quick TEMP

Technical specifications for quick temperature measurements.

A.11 IBP

Technical specifications for invasive blood pressure monitoring.

A.12 CO2

Technical specifications for CO2 monitoring.

A.13 C.O.

Technical specifications for cardiac output monitoring.

A.14 AG

Technical specifications for anesthetic gas monitoring.

A.15 Interfaces

Details on various interfaces available on the monitor.

A.15.1 Analog Output

Specifications for the analog output interface.

A.15.2 Defibrillator Synchronization

Specifications for defibrillator synchronization output.

A.15.3 Nurse Call

Specifications for the nurse call interface.

A.15.4 USB Interfaces

Specifications for the USB interfaces.

A.15.5 VGA Interface

Specifications for the VGA interface.

A.15.6 RS232 Interface

Specifications for the RS232 interface.

A.15.7 Wired Network Interface

Specifications for the wired network interface.

B EMC Information

B.1 Electromagnetic Emissions

Guidance and declaration on electromagnetic emissions.

B.2 Electromagnetic Immunity

Guidance and declaration on electromagnetic immunity.

B.4 Recommended Separation Distances

Recommended separation distances for RF communications equipment.

C Default Settings

C.1 Patient Information Default Settings

Default settings for patient information fields.

C.2 Alarm Default Settings

Default settings for alarm parameters.

C.3 ECG Default Settings

Default settings for ECG parameters and alarms.

C.4 RESP Default Settings

Default settings for respiration monitoring and alarms.

C.5 SpO2 Default Settings

Default settings for SpO2 monitoring and alarms.

C.6 PR Default Settings

Default settings for pulse rate monitoring.

C.7 NIBP Default Settings

Default settings for NIBP monitoring and alarms.

C.8 TEMP Default Settings

Default settings for temperature monitoring.

C.9 Quick TEMP Default Settings

Default settings for quick temperature measurements.

C.10 IBP Default Settings

Default settings for invasive blood pressure monitoring.

C.11 CO2 Default Settings

Default settings for CO2 monitoring.

C.12 C.O. Default Settings

Default settings for cardiac output monitoring.

C.13 AG Default Settings

Default settings for anesthetic gas monitoring.

D Abbreviations

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