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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 V6
Summarization of Contents
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use and Indications for Use
Details the intended purpose and parameters monitored by the patient monitor.
1.2 Safety Guidance
Provides essential safety instructions and warnings for using the device.
Chapter 2 Installation
2.1 Initial Inspection
Instructions for checking the packaging and contents before initial setup.
2.2 Mounting the Monitor
Guidance on how to physically position and install the patient monitor device.
2.3 Connecting the Power Cable
Steps for safely connecting the monitor to the AC power supply.
Chapter 3 Basic Operation
3.1 Overview
Provides a general overview of the monitor, its functions, and the main unit.
3.2 Operating and Navigating
3.2.1 Using Keys
Explains the different types of keys on the monitor: Permanent, Shortcut, Hardkeys, and Pop-up keys.
3.3 Setting Parameters
3.3.1 Accessing the Parameter Menu
Guides the user to access the MeasureSet menu to view and manage measurement modules.
3.4 Operating Mode
3.4.1 Demo Mode
Instructions for entering and exiting the demo mode for demonstration purposes only.
3.4.2 Standby Mode
Explains how to enter and the behavior of the monitor in standby mode.
3.5 Changing Monitor Settings
3.5.1 Adjusting Screen Brightness
Guides on how to change the monitor's screen brightness for optimal viewing.
3.5.2 Changing Date and Time
Refers to section for setting date and time, noting its impact on trend data storage.
3.6 Adjusting Volume
3.6.1 Adjusting Key Volume
Explains how to adjust the volume of key presses and knob interactions.
3.6.2 Adjusting Alarm Volume
Provides steps to adjust the volume for all audible alarm signals.
3.6.3 Adjusting Beat Volume
Details how to change the beat volume, which is dependent on the beat source setting.
Chapter 4 Alarms
4.1 Alarm Category
Describes the types of alarms: physiological, technical, and prompts.
4.2 Alarm Levels
Classifies alarms into three severity levels: high, medium, and low.
4.3 Controlling Alarm
4.3.1 Setting Parameter Alarm
Explains how to configure alarm settings for individual parameters: switch, record, level, and limit.
4.3.2 Audio Alarm Paused
Describes how to temporarily pause audible alarms and set the pause duration.
4.3.3 Audio Alarm off
Details how to turn off audible alarms permanently and the associated status display.
Chapter 5 Alarm Information
5.1 Physiological Alarm Information
Lists physiological alarms, their causes, and alarm levels, including those that cannot be turned off.
Chapter 6 Managing Patients
6.1 Admitting a Patient
Guides on entering patient information for safe and accurate monitoring, including category and safety limits.
6.1.1 Patient Category and Paced Status
Explains how patient category and paced status affect algorithms, safety limits, and alarm ranges.
6.2 Quick Admit
Allows quick patient admission with later completion of information.
6.3 Barcode Admit
Describes using a barcode scanner for convenient and accurate patient information entry.
6.4 Editing Patient Information
Instructions for modifying patient data after admission.
Chapter 7 User Interface
7.1 Setting Interface Style
Allows customization of the interface based on requirements, including waveform sweep and monitored parameters.
7.2 Selecting Display Parameters
Guides on choosing parameters to display based on monitoring needs via shortcut key or menu.
7.3 Changing Waveform Position
Explains how to exchange the positions of parameter A and parameter B waveforms.
7.4 Changing Interface Layout
Instructions for adjusting the display setup, including view selection, waveform count, and control bar visibility.
7.9 Viewing the Bed View Window
7.9.1 Opening the Bed View window
Steps to open the Bed View window after ensuring the function is configured.
7.9.2 Settings of the Bed View Window
Explains how to assign beds and select waveforms for display in the Bed View window.
Chapter 8 Monitoring ECG
8.1 Overview
Introduces ECG monitoring, displaying electrical activity as waveforms and numerics, including arrhythmia and ST monitoring.
8.2 ECG Safety Information
Provides critical safety warnings and precautions for ECG monitoring, including lead usage and electrode placement.
8.3 ECG Display
8.3.1 Changing the Size of the ECG Wave
Guides on adjusting the ECG waveform size for better visibility.
8.3.2 Changing the ECG Filter Settings
Details how to change ECG filter settings (Monitor, Surgery, Diagnosis) to smooth waves.
8.5 Monitoring Procedure
8.5.1 Preparation
Outlines skin preparation steps to ensure good electrode contact for ECG monitoring.
8.5.2 Connecting ECG Cables
Provides step-by-step instructions for connecting ECG cables and electrodes to the patient and monitor.
8.5.3 Selecting Lead Type
Guides on changing the ECG lead type to 3, 5, or 12 leads based on usage.
8.6 ECG Menu Setup
8.6.1 Setting Alarm Source
Explains how to set the alarm source for HR and PR, including the AUTO option.
8.7 12-Lead ECG Monitoring
8.7.1 Activating 12-Lead ECG Monitoring
Provides instructions for activating the 12-lead ECG monitoring function using SN number and password.
8.7.2 Analysis Function
Explains how to perform automatic analysis for 12-lead ECG monitoring and view results.
8.8 ST Segment Monitoring
8.8.1 Setting ST Analysis
Guides on enabling or disabling ST analysis via the ECG setup menu.
8.8.2 ST Display
Notes that monitor screen configuration may differ from illustrations.
8.9 Arrhythmia Monitoring
8.9.1 Arrhythmia Analysis
Explains the arrhythmia algorithm for detecting heart rate and rhythm changes, generating alarms, and its clinical validation.
8.9.2 ARR Analysis Menu
8.9.2.1 Switching ARR Analysis On and Off
Instructions on how to toggle ARR analysis between On and Off states.
8.9.2.2 ARR Alarm Setup
Details how to configure ARR alarm settings: switch, level, record, and key ARR alarm switch authority.
Chapter 9 Monitoring RESP
9.1 Overview
Explains how the monitor measures respiration using thoracic impedance and produces a waveform.
9.2 RESP Safety Information
Provides crucial safety warnings and precautions related to respiration monitoring, including apnea detection and potential interference.
Chapter 10 Monitoring SpO2
10.1 Overview
Introduces SpO2 monitoring for arterial blood oxygen saturation, also providing pulse rate and plethysmogram.
10.2 SpO2 Safety Information
Provides critical safety warnings and precautions for SpO2 sensors and their application.
10.3 Measuring SpO2
10.3.1 Measurement Procedure
Guides on selecting patient category and ensuring proper sensor application for SpO2 measurement.
10.11 SatSeconds Alarm Management*
10.11.1 Describing SatSeconds
Details the SatSeconds calculation method and how it triggers alarms based on accumulated points.
10.11.2 SatSeconds “Safety Net”
Describes the SatSeconds Safety Net feature that triggers alarms for frequent excursions even if the limit isn't reached.
10.11.3 Setting SatSeconds Duration
Guides on configuring the SatSeconds duration setting (Off, 10, 25, 50, 100).
Chapter 11 Monitoring PR
11.1 Overview
Defines pulse rate as arterial pulsations per minute, obtainable from SpO2 or arterial pressure.
11.2 Setting PR Source
Explains how to select SpO2 or arterial pressure labels as the PR source.
11.3 Setting PR Volume
Details how to adjust the PR volume using bars, with options for turning it off.
11.4 Selecting the Active Alarm Source
Guides on choosing ECG or PR as the active alarm source to avoid simultaneous alarms on HR and PR.
Chapter 12 Monitoring NIBP
12.1 Overview
Introduces NIBP measurement using the oscillometric method for adults, pediatrics, and neonates.
12.2 NIBP Safety Information
Provides critical safety warnings and precautions for NIBP measurements, including patient conditions and limb application.
12.5 Measurement Procedures
12.5.1 Operation Prompts
Details the prompts for Manual, Automatic, and Continuous NIBP measurement modes.
12.5.2 Correcting the Measurement if Limb is not at Heart Level
Explains how to correct NIBP measurements based on limb position relative to heart level.
Chapter 13 Monitoring TEMP
13.1 Overview
Introduces body temperature measurement using thermistor probes applied to skin or rectum.
13.2 TEMP Safety Information
Provides critical safety warnings and precautions for temperature probe usage and handling.
Chapter 14 Monitoring IBP
14.1 Overview
Introduces IBP measurement using a catheter and pressure transducer to display waveforms and pressures.
14.2 IBP Safety Information
Provides critical safety warnings and precautions for invasive blood pressure monitoring, including connections and transducer usage.
14.3 Monitoring Procedures
14.3.1 Selecting a Pressure for Monitoring
Guides on selecting the pressure label (ART, PA, CVP, etc.) for monitoring, which affects stored settings and algorithms.
14.3.2 Zeroing the Pressure Transducer
Details the procedure for zeroing the pressure transducer to ensure accurate readings, including when it's necessary.
14.6 Measuring PAWP
14.6.1 Measurement Procedures
Provides detailed steps for measuring PAWP, including catheter wedging, balloon inflation, and freezing waveforms.
Chapter 15 Monitoring CO2
15.1 Overview
Introduces CO2 monitoring methods (sidestream, mainstream) and the principle of infrared absorption.
15.2 CO2 Safety Information
Provides critical safety warnings and precautions related to CO2 monitoring, including environmental conditions and gas compensation.
15.3 Monitoring Procedures
15.3.1 Zeroing the Sensor
Details manual zeroing procedures for EDAN EtCO2, Respironics Sidestream, and Mainstream CO2 modules.
15.3.2 Sidestream CO2 Module
Provides measurement steps for EDAN EtCO2 and Respironics Sidestream CO2 modules.
15.3.3 Mainstream CO2 Module
15.3.3.1 Measurement Steps
Guides on attaching the mainstream CO2 module, warming up, connecting the airway adapter, and zeroing the sensor.
Chapter 16 Monitoring C.O.
16.1 Overview
Introduces Cardiac Output (C.O.) measurement using the Thermodilution method.
16.2 C.O. Safety Information
Provides critical safety warnings and precautions for Cardiac Output monitoring, including appurtenance and electrosurgery use.
16.3 C.O. Monitoring
Preparing Measurement
Steps to prepare for C.O. measurement, including connecting the cable and attaching probes.
Performing C.O. Measurement
16.3.1.1 Performing C.O. Measurement
Guides on picking the C.O. Measure item and understanding the C.O. Measure menu display.
Chapter 17 Monitoring AG
17.1 Overview
Introduces anesthetic gas (AG) monitoring using ISA, Dräger Minimodule, and IRMA modules.
17.2 Safety Information
17.2.1 Safety Information for ISA Analyzer
Provides critical safety warnings and precautions for using the ISA sidestream gas analyzer.
17.3 Monitoring Steps
Nomoline Family Sampling Lines
Describes the use of Nomoline Family sampling lines for ISA gas analysis, including their features and configurations.
17.3.1 Monitoring Steps for ISA Module
Guides on performing pre-use checks for the ISA module, including connecting the line and checking indicators.
Chapter 18 Monitoring BIS*
18.1 Overview
Introduces Bispectral Index (BIS) monitoring to assess hypnotic state using EEG signals and the BIS numeric.
18.5 BIS Sensor Check
18.5.1 Starting a Sensor Check
Guides on starting a sensor check manually via the V-BIS module or setup menu.
18.5.2 Stopping a Sensor Check
Explains how to stop a sensor check manually.
Chapter 19 Monitoring RM*
19.1 Overview
Introduces RM monitoring for respiratory mechanics, providing numerics and waveforms for flow, volume, and pressure.
19.5 Purging
19.5.1 Automatic Purging
Explains the automatic purge cycle performed during measurement at set intervals.
19.5.2 Manual Purging
Details how to perform manual purging when water condensation or abnormal flow wave occurs.
19.6 Gas Compensation
19.6.1 Changing the Concentration of Inspired O2 and Inspired Agents
Guides on adjusting O2 and anesthetic agent compensation settings.
19.6.2 Changing the Type of Balance Gas
Explains how to select a balance gas from the drop-down list for air compensation.
19.6.3 Changing the Temperature of the Inspired and Expired Gas
Guides on setting Fi and Et temperature for air compensation.
19.6.4 Changing the Humidity of the Inspired and Expired Gas
Guides on setting Fi and Et humidity for air compensation.
19.7 RM Configuration
19.7.1 Changing the Apnea Alarm Delay
Sets the time limit for apnea alarms when the patient stops breathing.
19.7.2 Selecting Measured Airway Volume Components
Allows selection of tidal volume (TV) or minute volume (MV) for display in the Vol parameter window.
19.7.3 Changing the Respiration Mode
Guides on selecting between Spontaneous and Mechanical respiration modes.
19.7.4 Selecting Waveform
Allows selection of Flow or Vol waveform for display.
19.8 Respiratory Loops
19.8.1 Viewing Loops
Guides on viewing respiratory loops via the RM Setup menu.
19.8.2 Storing and Reviewing Loops
Details how to save and review respiratory loops for reference.
19.8.3 Changing Loop Type
Allows changing the loop type from a drop-down list.
19.8.4 Showing/Hiding the Reference Loop
Explains how to show or hide the reference loop.
19.8.5 Resizing the Loops
Guides on resizing loops by setting top and bottom rulers.
Chapter 20 Monitoring ICG*
20.1 Overview
Introduces Impedance Cardiography (ICG) monitoring for hemodynamic parameters and ventricular function assessment.
20.5 Starting a Measurement
20.5.1 Measurement Procedure
Outlines steps for starting ICG measurement, including connecting the cable, preparing skin, and entering patient information.
20.5.2 ICG Sensor Application
Details proper sensor placement for accurate ICG measurements on the neck and thorax.
Chapter 21 V-Link Module*
21.1 Overview
Introduces the V-Link module for transmitting information and alarms from external devices to the monitor.
21.2 Safety Information
Provides critical safety warnings and precautions for using the V-Link module and external devices.
21.6 External Device Displaying and Settings on Monitor
21.6.1 NMT Displaying and Settings
Details NMT stimulation methods (SS, TOF, PTC, DBS, TET) and their parameters.
21.6.2 V/A (Ventilator and Anesthetic Device) Displaying and Settings
Guides on opening the Anes/Vent window to display and set parameters from connected ventilators or anesthetic devices.
Chapter 22 LiDCO Module*
22.1 Overview
Introduces LiDCOplus and LiDCOrapid for hemodynamic monitoring.
22.2 LiDCO Displaying and Settings
Explains how LiDCO provides parameters and allows color setup for parameters and waveforms.
22.3 Alarms from LiDCO Module
Describes how the monitor handles LiDCO module alarms and notifications.
Chapter 23 Freeze
23.1 Entering/Exiting Freeze Status
Guides on entering and exiting the freeze status to examine waveforms.
23.2 Reviewing Frozen Waveform
Explains how to review frozen waveforms using time and arrow keys.
Chapter 24 Review
24.1 Trend Graph Review
Guides on reviewing trend graphs by selecting parameters, adjusting scale, time span, and cursor.
24.2 Trend Table Review
Explains how to review trend data in a table format, adjusting parameters and intervals.
Chapter 25 Calculation and Titration Table
25.1 Drug Calculation
Explains the drug calculation function, including procedures, available drugs, and unit series.
25.1.1 Calculation Procedures
Guides on accessing the drug calculation window and selecting drugs.
25.1.2 Calculation Unit
Lists the calculation units for various drugs, noting variations based on entered parameters.
25.1.3 Titration Table
Mentions changing items like Basic and Step in the titration table after drug calculation.
25.2 Hemodynamic Calculation
25.2.1 Calculation Procedure
Guides on accessing the hemodynamic calculation interface and entering required values.
25.2.2 Input Parameters
Lists input parameters required for hemodynamic calculations, including PAWP, CVP, HR, etc.
25.2.3 Output Parameters
Lists output parameters calculated from hemodynamic data, such as CI, BSA, SV.
25.3 Oxygenation Calculation
25.3.1 Calculation Procedure
Guides on accessing the oxygenation calculation interface and entering required values.
25.3.2 Input Parameters
Lists input parameters for oxygenation calculations, including C.O., FiO2, PaO2, etc.
25.3.3 Output Parameters
Lists output parameters calculated from oxygenation data, such as BSA, VO2 calc, O2ER.
25.4 Ventilation Calculation
25.4.1 Calculation Procedure
Guides on accessing the ventilation calculation interface and entering required values.
25.4.2 Input Parameters
Lists input parameters for ventilation calculations, including FiO2, RR, PIP, PEEP.
25.4.3 Output Parameters
Lists output parameters calculated from ventilation data, such as PAO2, AaDO2, MV.
25.5 Renal Function Calculation
25.5.1 Calculation Procedure
Guides on accessing the renal function calculation interface and entering required values.
25.5.2 Input Parameters
Lists input parameters for renal function calculations, including URK, URNa, BUN, etc.
25.5.3 Output Parameters
Lists output parameters calculated from renal function data, such as URNaEx, URKEx, CCr.
Chapter 26 Recording
26.1 Performance of the Recorder
Describes the recorder's performance, including print speed, paper width, and waveform recording capabilities.
26.2 Starting and Stopping Recording
Explains how to start and stop different types of stripe recording on the monitor.
26.3 Recorder Operations and Status Messages
26.3.1 Record Paper Requirement
Specifies the requirement for using only standard thermosensitive record paper to avoid malfunction.
26.3.2 Proper Operation
Provides guidelines for proper operation of the recorder, including paper handling and avoiding damage.
26.3.3 Paper Out
Describes the "Recorder Out Of Paper" alarm and the need to insert paper properly.
26.3.4 Replacing Paper
Details the steps for replacing the record paper in the printer.
26.3.5 Removing Paper Jam
Explains how to open the recorder casing to check for and remove paper jams.
Chapter 27 Printing Patient Reports
27.1 Printer Settings
Guides on configuring printer settings on the monitor for printing patient reports, including network setup.
27.2 Starting and Stopping Report Printing
Explains how to print various types of patient reports and manage print jobs.
Chapter 28 Other Functions
28.1 Nurse Call
Describes the dedicated nurse call port for connecting to a nurse call system.
28.2 Wireless Network
Guides on configuring Wi-Fi settings for connecting the monitor to a wireless network.
28.3 Storing Data in the Storage Device
28.3.1 Data Stored in the Storage Device
Details the types of data stored and storage volume information.
28.3.2 Activating/ Deactivating Data Storing
Explains how to turn the data storing function on or off and the circumstances under which storing stops.
28.4 MEWS*
28.4.1 MEWS Score Interface
Describes the three methods to enter the MEWS score system interface.
28.4.2 MEWS Score Criteria
Details the criteria used to score HR, SYS, RESP, TEMP, Consciousness, and Age in the MEWS interface.
Chapter 29 Using Battery
29.1 Battery Safety Information
Provides critical safety warnings and precautions for using rechargeable lithium-ion batteries.
Chapter 30 Care and Cleaning
30.1 General Points
Provides general guidelines for keeping the monitor clean, including using recommended substances and avoiding liquids.
30.2 Cleaning
Details cleaning procedures for the device and accessories after patient contact or for daily maintenance.
30.2.2 Cleaning the Reusable Accessories
30.2.2.1 Cleaning the ECG Cable Assembly
Guides on cleaning the ECG cable assembly with disinfectant solution.
30.2.2.2 Cleaning the Blood Pressure Cuff
Details disinfection procedures for the blood pressure cuff and air bladder.
30.3 Disinfection
30.3.1 Disinfecting the Monitor
Step-by-step guide for disinfecting the monitor using approved solutions.
30.3.2 Disinfecting the Reusable Accessories
Instructions for disinfecting reusable accessories like ECG cable assembly and blood pressure cuffs.
Chapter 31 Maintenance
31.1 Inspecting
Outlines the overall check and safety inspection of the monitor to be performed by qualified personnel.
31.2 Maintenance Task and Test Schedule
Details maintenance tasks and test schedules, recommending professional service every two years.
Chapter 32 Warranty and Service
32.1 Warranty
Explains the product warranty terms, conditions, and exclusions for EDAN products.
32.2 Contact Information
Provides contact details for service inquiries, technical specifications, and malfunctions.
Chapter 33 Accessories
33.1 ECG Accessories
Lists various ECG accessories, including part numbers, types, and compatibility.
A Product Specifications
A.1 Classification
Details the product's classification for anti-electroshock type, degree, ingress protection, working system, and compliance standards.
A.2 Physical Specifications
Provides physical specifications for the monitor models (elite V5, V6, V8) and modules (XM, V-IBP, etc.), including dimensions and weight.
A.9 Data Management
Data Review
Details data review capabilities (Trend Data, Alarm Events, NIBP, Arrhythmia, 12-Lead).
A.20 AG
A.20.1 Sidestream
Details Sidestream AG monitoring specifications for ISA analyzer, including module types, parameters, principle, flow rate, and compensations.
A.25 Interfaces
A.25.1 Analog Output
Details analog output specifications including bandwidth, transmission delay, sensitivity, and interface type.
A.25.2 Defibrillator Synchronization
Provides specifications for defibrillator synchronization, including output impedance, time delay, and amplitude.
B EMC Information
B.1 Electromagnetic Emissions
Provides guidance and manufacturer's declaration on electromagnetic emissions (RF, harmonic, voltage fluctuations).
B.2 Electromagnetic Immunity
Provides guidance and manufacturer's declaration on electromagnetic immunity (conducted RF, radiated RF).
C Default Settings
C.1 Patient Information Default Settings
Documents the default settings for patient information such as type and pace.
C.2 Alarm Default Settings
Documents the default settings for alarm parameters like pause time, sensor off, and latch.
C.3 ECG Default Settings
Documents the default settings for ECG parameters like alarm switch, record, level, and limits.
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