EDAN elite V5 User manual

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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.)

I
About this Manual
P/N: 01.54.456341
MPN: 01.54.456341019
Release Date: September, 2018
© Copyright EDAN INSTRUMENTS, INC. 2014-2018. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.

II
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

III
Table of Contents
Chapter 1 Intended Use and Safety Guidance ................................................................................1
1.1 Intended Use/Indications for Use...........................................................................................1
1.2 Safety Guidance .....................................................................................................................1
1.2.1 Protecting Personal Information .................................................................................7
1.3 Explanation of Symbols on the Monitor ................................................................................8
Chapter 2 Installation ......................................................................................................................12
2.1 Initial Inspection...................................................................................................................12
2.2 Mounting the Monitor..........................................................................................................12
2.3 Connecting the Power Cable................................................................................................12
2.4 Checking the Monitor ..........................................................................................................13
2.5 Checking the Recorder.........................................................................................................13
2.6 Setting Date and Time..........................................................................................................13
2.7 Handing Over the Monitor...................................................................................................13
2.8 FCC Statement .....................................................................................................................14
2.9 FCC RF Radiation Exposure Statement...............................................................................14
Chapter 3 Basic Operation..............................................................................................................15
3.1 Overview ..............................................................................................................................15
3.1.1 Main Unit ..................................................................................................................15
3.1.2 Parameter Amplifier Mainframe ...............................................................................24
3.1.3 Measurement Modules..............................................................................................25
3.1.4 XM Module...............................................................................................................27
3.1.5 iM20 ..........................................................................................................................29
3.2 Operating and Navigating ....................................................................................................29
3.2.1 Using Keys................................................................................................................31
3.3 Setting Parameters................................................................................................................32
3.3.1 Accessing the Parameter Menu .................................................................................32
3.3.2 Activating / Deactivating a Parameter Measurement................................................34
3.3.3 Resolving Module Conflicts .....................................................................................34
3.3.4 Resolving IBP Label Conflicts..................................................................................34
3.4 Operating Mode ...................................................................................................................35
3.4.1 Demo Mode...............................................................................................................35
3.4.2 Standby Mode ...........................................................................................................35
3.4.3 Night Mode ...............................................................................................................36
3.4.4 Privacy Mode ............................................................................................................36
3.4.5 NFC Mode.................................................................................................................37
3.5 Changing Monitor Settings ..................................................................................................38
3.5.1 Adjusting Screen Brightness .....................................................................................38
3.5.2 Changing Date and Time...........................................................................................38
3.6 Adjusting Volume.................................................................................................................38

IV
3.6.1 Adjusting Key Volume ..............................................................................................38
3.6.2 Adjusting Alarm Volume ...........................................................................................38
3.6.3 Adjusting Beat Volume..............................................................................................38
3.7 Checking Your Monitor Version ..........................................................................................39
3.8 Networked Monitoring.........................................................................................................39
3.9 Setting Languages ................................................................................................................39
3.10 Calibrating Screens ............................................................................................................39
3.11 Disabling the Touch Screen................................................................................................40
3.12 Using the Bar Code Scanner ..............................................................................................40
Chapter 4 Alarms .............................................................................................................................41
4.1 Alarm Category ....................................................................................................................41
4.1.1 Physiological Alarms ................................................................................................41
4.1.2 Technical Alarms.......................................................................................................41
4.1.3 Prompts .....................................................................................................................41
4.2 Alarm Levels ........................................................................................................................41
4.3 Controlling Alarm ................................................................................................................43
4.3.1 Setting Parameter Alarm ...........................................................................................43
4.3.2 Audio Alarm Paused..................................................................................................44
4.3.3 Audio Alarm off ........................................................................................................44
4.3.4 Alarm Reset...............................................................................................................45
4.4 Latching Alarms ...................................................................................................................45
4.5 Disabling Sensor off Alarms ................................................................................................45
4.6 Network Disconnected Alarms ............................................................................................46
4.7 Testing Alarms......................................................................................................................46
Chapter 5 Alarm Information.........................................................................................................47
5.1 Physiological Alarm Information.........................................................................................47
5.2 Technical Alarm Information ...............................................................................................53
5.3 Prompts ................................................................................................................................71
5.4 Adjustable Range of Alarm Limits.......................................................................................75
Chapter 6 Managing Patients .........................................................................................................79
6.1 Admitting a Patient...............................................................................................................79
6.1.1 Patient Category and Paced Status ............................................................................80
6.2 Quick Admit.........................................................................................................................80
6.3 Barcode Admit .....................................................................................................................80
6.4 Editing Patient Information..................................................................................................80
6.5 Central Monitoring System..................................................................................................81
Chapter 7 User Interface.................................................................................................................82
7.1 Setting Interface Style ..........................................................................................................82
7.2 Selecting Display Parameters...............................................................................................82
7.3 Changing Waveform Position ..............................................................................................82
7.4 Changing Interface Layout...................................................................................................82

V
7.5 Viewing Trend Screen ..........................................................................................................83
7.6 Viewing OxyCRG Screen ....................................................................................................83
7.7 Viewing Large Font Screen..................................................................................................83
7.8 Viewing the Vital Screen......................................................................................................84
7.9 Viewing the Bed View Window ...........................................................................................84
7.9.1 Opening the Bed View Window................................................................................84
7.9.2 Settings of the Bed View Window ............................................................................84
7.10 Changing Parameter and Waveform Colors.......................................................................84
7.11 User Configuration.............................................................................................................85
7.12 Default Configuration ........................................................................................................85
Chapter 8 Monitoring ECG ............................................................................................................86
8.1 Overview ..............................................................................................................................86
8.2 ECG Safety Information ......................................................................................................86
8.3 ECG Display ........................................................................................................................88
8.3.1 Changing the Size of the ECG Wave ........................................................................88
8.3.2 Changing the ECG Filter Settings.............................................................................89
8.4 Selecting Calculation Lead ..................................................................................................89
8.5 Monitoring Procedure ..........................................................................................................90
8.5.1 Preparation ................................................................................................................90
8.5.2 Connecting ECG Cables ...........................................................................................90
8.5.3 Selecting Lead Type ..................................................................................................90
8.5.4 Installing Electrodes..................................................................................................91
8.6 ECG Menu Setup .................................................................................................................94
8.6.1 Setting Alarm Source ................................................................................................94
8.6.2 Setting Beat Source...................................................................................................95
8.6.3 Smart Lead Off..........................................................................................................95
8.6.4 ECG Display .............................................................................................................95
8.6.5 Setting Pace Status ....................................................................................................96
8.6.6 ECG Calibration........................................................................................................96
8.6.7 ECG Waveform Settings ...........................................................................................97
8.7 12-Lead ECG Monitoring ....................................................................................................97
8.7.1 Activating 12-Lead ECG Monitoring........................................................................97
8.7.2 Analysis Function......................................................................................................97
8.7.3 Waveform Durations and Isoelectric Segments ........................................................98
8.8 ST Segment Monitoring.......................................................................................................98
8.8.1 Setting ST Analysis ...................................................................................................99
8.8.2 ST Display.................................................................................................................99
8.8.3 About ST Measurement Points................................................................................100
8.8.4 Adjusting ST and ISO Measurement Points............................................................100
8.9 Arrhythmia Monitoring ......................................................................................................100
8.9.1 Arrhythmia Analysis................................................................................................100

VI
8.9.2 ARR Analysis Menu................................................................................................105
Chapter 9 Monitoring RESP.........................................................................................................107
9.1 Overview ............................................................................................................................107
9.2 RESP Safety Information ...................................................................................................107
9.3 Electrode Placement for Monitoring RESP .......................................................................108
9.4 Cardiac Overlay .................................................................................................................108
9.5 Chest Expansion.................................................................................................................108
9.6 Abdominal Breathing .........................................................................................................109
9.7 Selecting RESP Lead .........................................................................................................109
9.8 Changing Hold Type ..........................................................................................................109
9.9 Changing the Size and Speed of the Respiration Wave .....................................................109
9.10 Changing the Apnea Alarm Time.....................................................................................109
Chapter 10 Monitoring SpO2........................................................................................................ 110
10.1 Overview ..........................................................................................................................110
10.2 SpO2Safety Information..................................................................................................110
10.3 Measuring SpO2............................................................................................................... 111
10.4 Measurement Limitations.................................................................................................112
10.5 Assessing the Validity of a SpO2Reading........................................................................ 113
10.6 SpO2Alarm Delay............................................................................................................114
10.7 Perfusion Index (PI)* .......................................................................................................114
10.8 Measuring SpO2and NIBP Simultaneously.....................................................................114
10.9 Setting Pitch Tone ............................................................................................................ 115
10.10 Setting Sensitivity ..........................................................................................................115
10.11 SatSeconds Alarm Management*...................................................................................115
10.11.1 Describing SatSeconds........................................................................................115
10.11.2 SatSeconds “Safety Net”.....................................................................................116
10.11.3 Setting SatSeconds Duration...............................................................................116
Chapter 11 Monitoring PR ............................................................................................................ 117
11.1 Overview ..........................................................................................................................117
11.2 Setting PR Source.............................................................................................................117
11.3 Setting PR Volume ...........................................................................................................117
11.4 Selecting the Active Alarm Source...................................................................................117
Chapter 12 Monitoring NIBP ....................................................................................................... 118
12.1 Overview ..........................................................................................................................118
12.2 NIBP Safety Information .................................................................................................118
12.3 Measurement Limitations.................................................................................................120
12.4 Measurement Methods.....................................................................................................120
12.5 Measurement Procedures .................................................................................................120
12.5.1 Operation Prompts ................................................................................................122
12.5.2 Correcting the Measurement if Limb is not at Heart Level ..................................122
12.6 NIBP Multi-Review Window...........................................................................................122

VII
12.7 Resetting NIBP.................................................................................................................122
12.8 Calibrating NIBP..............................................................................................................122
12.9 Leakage Test.....................................................................................................................123
12.10 Setting Inflation Mode ...................................................................................................124
Chapter 13 Monitoring TEMP......................................................................................................125
13.1 Overview ..........................................................................................................................125
13.2 TEMP Safety Information ................................................................................................125
13.3 Switching T1/T2 On/Off ..................................................................................................126
13.4 TEMP Monitoring Setup ..................................................................................................126
13.5 Calculating Temp Difference ...........................................................................................126
Chapter 14 Monitoring IBP ..........................................................................................................127
14.1 Overview ..........................................................................................................................127
14.2 IBP Safety Information ....................................................................................................127
14.3 Monitoring Procedures.....................................................................................................128
14.3.1 Selecting a Pressure for Monitoring......................................................................129
14.3.2 Zeroing the Pressure Transducer...........................................................................129
14.3.3 Troubleshooting the Pressure Zeroing (Taking Art for Example).........................130
14.3.4 IBP Calibration......................................................................................................130
14.4 Changing the IBP Waveform Ruler..................................................................................130
14.5 IBP Waveform Overlapping .............................................................................................130
14.6 Measuring PAWP .............................................................................................................131
14.6.1 Measurement Procedures ......................................................................................131
14.7 Calculating CPP ...............................................................................................................132
14.7.1 Calculation Procedures..........................................................................................132
14.8 Calculating PPV...............................................................................................................132
Chapter 15 Monitoring CO2..........................................................................................................134
15.1 Overview ..........................................................................................................................134
15.2 CO2Safety Information....................................................................................................135
15.3 Monitoring Procedures.....................................................................................................136
15.3.1 Zeroing the Sensor ................................................................................................136
15.3.2 Sidestream CO2 Module ........................................................................................136
15.3.3 Mainstream CO2Module ......................................................................................139
15.4 Setting CO2Corrections...................................................................................................140
15.5 Setting Apnea Alarm Time...............................................................................................141
15.6 Setting CO2Waveform.....................................................................................................141
Chapter 16 Monitoring C.O..........................................................................................................142
16.1 Overview ..........................................................................................................................142
16.2 C.O. Safety Information...................................................................................................142
16.3 C.O. Monitoring ...............................................................................................................143
16.4 Blood Temperature Monitoring........................................................................................147
Chapter 17 Monitoring AG ...........................................................................................................148

VIII
17.1 Overview ..........................................................................................................................148
17.2 Safety Information ...........................................................................................................149
17.2.1 Safety Information for ISA Analyzer ....................................................................149
17.2.2 Safety Information for Dräger Minimodule..........................................................151
17.2.3 Safety Information for IRMA Module ..................................................................152
17.3 Monitoring Steps..............................................................................................................154
17.3.1 Monitoring Steps for ISA Module.........................................................................155
17.3.2 Monitoring Steps for Dräger Minimodule ............................................................157
17.3.3 Monitoring Steps for IRMA Module.....................................................................159
17.4 Setting Apnea Alarm Time...............................................................................................161
17.5 Working Status of ISA analyzer .......................................................................................161
17.6 Working Status of IRMA Module ....................................................................................161
17.7 O2Compensations............................................................................................................162
17.8 Effects of Humidity..........................................................................................................162
Chapter 18 Monitoring BIS*.........................................................................................................163
18.1 Overview ..........................................................................................................................163
18.2 Safety Information ...........................................................................................................165
18.3 BIS Monitoring Setup ......................................................................................................167
18.4 BIS Continuous Impedance Check ..................................................................................168
18.5 BIS Sensor Check ............................................................................................................168
18.5.1 Starting a Sensor Check ........................................................................................168
18.5.2 Stopping a Sensor Check ......................................................................................168
18.6 BIS Sensor Window .........................................................................................................169
18.7 Changing the BIS Smoothing Rate ..................................................................................170
18.8 Switching Secondary Parameters On and Off..................................................................170
18.9 Changing the Scale of the EEG Wave..............................................................................170
18.10 Setting the Trend Length................................................................................................170
18.11 Switching BIS Filters On or Off.....................................................................................170
Chapter 19 Monitoring RM* ........................................................................................................171
19.1 Overview ..........................................................................................................................171
19.2 Safety Information ...........................................................................................................172
19.3 Sensor Setup.....................................................................................................................175
19.4 Zero Calibration ...............................................................................................................176
19.5 Purging .............................................................................................................................176
19.5.1 Automatic Purging ................................................................................................176
19.5.2 Manual Purging.....................................................................................................176
19.6 Gas Compensation ...........................................................................................................176
19.6.1 Changing the Concentration of Inspired O2and Inspired Agents.........................177
19.6.2 Changing the Type of Balance Gas .......................................................................177
19.6.3 Changing the Temperature of the Inspired and Expired Gas ................................177
19.6.4 Changing the Humidity of the Inspired and Expired Gas .....................................178

IX
19.7 RM Configuration ............................................................................................................178
19.7.1 Changing the Apnea Alarm Delay.........................................................................178
19.7.2 Selecting Measured Airway Volume Components................................................178
19.7.3 Changing the Respiration Mode............................................................................178
19.7.4 Selecting Waveform ..............................................................................................178
19.8 Respiratory Loops ............................................................................................................178
19.8.1 Viewing Loops ......................................................................................................179
19.8.2 Storing and Reviewing Loops...............................................................................179
19.8.3 Changing Loop Type.............................................................................................179
19.8.4 Showing/Hiding the Reference Loop....................................................................179
19.8.5 Resizing the Loops................................................................................................179
Chapter 20 Monitoring ICG* .......................................................................................................180
20.1 Overview ..........................................................................................................................180
20.2 Safety Information ...........................................................................................................181
20.3 ICG Patient Cable ............................................................................................................181
20.4 Precautions and Limitations.............................................................................................182
20.5 Starting a Measurement....................................................................................................183
20.5.1 Measurement Procedure........................................................................................183
20.5.2 ICG Sensor Application ........................................................................................183
20.5.3 Setting Patient Data...............................................................................................184
20.6 Selecting Secondary Parameters ......................................................................................184
Chapter 21 V-Link Module* .........................................................................................................185
21.1 Overview ..........................................................................................................................185
21.2 Safety Information ...........................................................................................................185
21.3 Connecting an External Device........................................................................................186
21.4 Activating / Deactivating V-Link Module........................................................................187
21.5 Alarms from the External Device.....................................................................................187
21.6 External Device Displaying and Settings on Monitor......................................................188
21.6.1 NMT Displaying and Settings...............................................................................188
21.6.2 V/A (Ventilator and Anesthetic Device) Displaying and Settings.........................188
21.7 V-Link Maintenance.........................................................................................................191
Chapter 22 LiDCO Module*.........................................................................................................192
22.1 Overview ..........................................................................................................................192
22.2 LiDCO Displaying and Settings.......................................................................................192
22.3 Alarms from LiDCO Module...........................................................................................192
Chapter 23 Freeze ..........................................................................................................................193
23.1 Entering/Exiting Freeze Status.........................................................................................193
23.1.1 Entering Freeze Status...........................................................................................193
23.1.2 Exiting Freeze Status.............................................................................................193
23.2 Reviewing Frozen Waveform...........................................................................................193
Chapter 24 Review .........................................................................................................................194

X
24.1 Trend Graph Review ........................................................................................................194
24.2 Trend Table Review .........................................................................................................195
24.3 NIBP Review....................................................................................................................196
24.4 Alarm Review...................................................................................................................196
24.5 ARR Review ....................................................................................................................196
24.6 12-Lead Analysis Review ................................................................................................197
Chapter 25 Calculation and Titration Table................................................................................198
25.1 Drug Calculation ..............................................................................................................198
25.1.1 Calculation Procedures..........................................................................................198
25.1.2 Calculation Unit ....................................................................................................199
25.1.3 Titration Table .......................................................................................................199
25.2 Hemodynamic Calculation...............................................................................................200
25.2.1 Calculation Procedure ...........................................................................................200
25.2.2 Input Parameters....................................................................................................200
25.2.3 Output Parameters.................................................................................................200
25.3 Oxygenation Calculation..................................................................................................201
25.3.1 Calculation Procedure ...........................................................................................201
25.3.2 Input Parameters....................................................................................................201
25.3.3 Output Parameters.................................................................................................202
25.4 Ventilation Calculation.....................................................................................................202
25.4.1 Calculation Procedure ...........................................................................................202
25.4.2 Input Parameters....................................................................................................203
25.4.3 Output Parameters.................................................................................................203
25.5 Renal Function Calculation..............................................................................................203
25.5.1 Calculation Procedure ...........................................................................................203
25.5.2 Input Parameters....................................................................................................204
25.5.3 Output Parameters.................................................................................................204
Chapter 26 Recording....................................................................................................................205
26.1 Performance of the Recorder ...........................................................................................205
26.2 Starting and Stopping Recording .....................................................................................205
26.3 Recorder Operations and Status Messages ......................................................................207
26.3.1 Record Paper Requirement ...................................................................................207
26.3.2 Proper Operation ...................................................................................................207
26.3.3 Paper Out...............................................................................................................207
26.3.4 Replacing Paper ....................................................................................................207
26.3.5 Removing Paper Jam.............................................................................................208
Chapter 27 Printing Patient Reports............................................................................................210
27.1 Printer Settings.................................................................................................................210
27.2 Starting and Stopping Report Printing .............................................................................210
Chapter 28 Other Functions..........................................................................................................212
28.1 Nurse Call.........................................................................................................................212

XI
28.2 Wireless Network .............................................................................................................212
28.3 Storing Data in the Storage Device ..................................................................................213
28.3.1 Data Stored in the Storage Device ........................................................................213
28.3.2 Activating/ Deactivating Data Storing ..................................................................213
28.3.3 Selecting a Storage Device....................................................................................214
28.3.4 Reviewing Data Stored in the Storage Device ......................................................214
28.3.5 Deleting Data Stored in the Storage Device..........................................................214
28.3.6 Exporting Data Stored in the Internal Storage Device..........................................214
28.3.7 Formatting the Internal Storage Device ................................................................215
28.3.8 Ejecting a Removable Device ...............................................................................215
28.4 MEWS*............................................................................................................................215
28.4.1 MEWS Score Interface .........................................................................................215
28.4.2 MEWS Score Criteria ...........................................................................................216
28.4.3 MEWS Score Method ...........................................................................................216
28.4.4 MEWS Score Result .............................................................................................216
28.4.5 MEWS Trend Table...............................................................................................217
Chapter 29 Using Battery..............................................................................................................218
29.1 Battery Safety Information...............................................................................................218
29.2 Battery Power Indicator ...................................................................................................219
29.3 Battery Status on the Main Screen ...................................................................................219
29.4 Checking Battery Performance ........................................................................................219
29.5 Replacing the Battery.......................................................................................................220
29.6 Recycling the Battery.......................................................................................................220
29.7 Maintaining the Battery....................................................................................................220
Chapter 30 Care and Cleaning .....................................................................................................221
30.1 General Points ..................................................................................................................221
30.2 Cleaning ...........................................................................................................................221
30.2.1 Cleaning the Monitor ............................................................................................222
30.2.2 Cleaning the Reusable Accessories.......................................................................222
30.3 Disinfection......................................................................................................................223
30.3.1 Disinfecting the Monitor.......................................................................................224
30.3.2 Disinfecting the Reusable Accessories..................................................................224
30.4 Cleaning and Disinfecting Other Accessories..................................................................225
Chapter 31 Maintenance ...............................................................................................................226
31.1 Inspecting .........................................................................................................................226
31.2 Maintenance Task and Test Schedule...............................................................................226
Chapter 32 Warranty and Service................................................................................................227
32.1 Warranty ...........................................................................................................................227
32.2 Contact Information .........................................................................................................227
Chapter 33 Accessories ..................................................................................................................228
33.1 ECG Accessories..............................................................................................................228

XII
33.2 SpO2Accessories .............................................................................................................230
33.3 NIBP Accessories.............................................................................................................231
33.4 TEMP Accessories ...........................................................................................................233
33.5 IBP Accessories................................................................................................................233
33.6 CO2Accessories ...............................................................................................................234
33.7 C.O. Accessories ..............................................................................................................235
33.8 AG Accessories ................................................................................................................236
33.9 BIS Accessories................................................................................................................236
33.10 RM Accessories..............................................................................................................237
33.11 ICG Accessories .............................................................................................................237
33.12 Other Accessories...........................................................................................................237
A Product Specifications................................................................................................................239
A.1 Classification.....................................................................................................................239
A.2 Physical Specifications......................................................................................................239
A.3 Environmental Specifications ...........................................................................................240
A.4 Power Supply ....................................................................................................................243
A.5 Battery ...............................................................................................................................243
A.6 Display ..............................................................................................................................244
A.7 Indicators...........................................................................................................................245
A.8 Recorder ............................................................................................................................245
A.9 Data Management .............................................................................................................246
A.10 Wi-Fi................................................................................................................................247
A.11 ECG .................................................................................................................................247
A.12 RESP ...............................................................................................................................252
A.13 NIBP................................................................................................................................253
A.14 SpO2................................................................................................................................256
A.15 TEMP ..............................................................................................................................257
A.16 PR....................................................................................................................................258
A.17 IBP...................................................................................................................................258
A.18 CO2..................................................................................................................................259
A.19 C.O. .................................................................................................................................264
A.20 AG ...................................................................................................................................265
A.20.1 Sidestream ............................................................................................................265
A.20.2 Mainstream...........................................................................................................270
A.21 BIS...................................................................................................................................273
A.22 RM...................................................................................................................................273
A.23 ICG..................................................................................................................................277
A.24 LiDCO.............................................................................................................................277
A.25 Interfaces .........................................................................................................................277
A.25.1 Analog Output ......................................................................................................277
A.25.2 Defibrillator Synchronization...............................................................................278

XIII
A.25.3 Nurse Call.............................................................................................................278
A.25.4 USB Interfaces .....................................................................................................279
A.25.5 VGA Interface ......................................................................................................279
A.25.6 DVI Interface*......................................................................................................279
A.25.7 RS232 Interface....................................................................................................280
A.25.8 PAM Interface* ....................................................................................................280
A.25.9 Wired Network Interface......................................................................................280
A.26 V-Link Module ................................................................................................................280
B EMC Information.......................................................................................................................281
B.1 Electromagnetic Emissions ...............................................................................................281
B.2 Electromagnetic Immunity ................................................................................................281
B.3 Electromagnetic Immunity ................................................................................................283
B.4 Recommended Separation Distances ................................................................................286
C Default Settings...........................................................................................................................287
C.1 Patient Information Default Settings .................................................................................287
C.2 Alarm Default Settings ......................................................................................................287
C.3 ECG Default Settings ........................................................................................................287
C.4 RESP Default Settings.......................................................................................................289
C.5 SpO2Default Settings........................................................................................................290
C.6 PR Default Settings ...........................................................................................................290
C.7 NIBP Default Settings .......................................................................................................290
C.8 TEMP Default Settings......................................................................................................291
C.9 IBP Default Settings ..........................................................................................................291
C.10 CO2Default Settings .......................................................................................................292
C.11 C.O. Default Settings.......................................................................................................292
C.12 AG Default Settings.........................................................................................................293
C.13 BIS Default Settings........................................................................................................293
C.14 RM Default Settings........................................................................................................294
C.15 ICG Default Settings .......................................................................................................295
C.16 V-Link Default Settings...................................................................................................295
C.17 V/A (Ventilator and Anesthetic device) Default Settings ................................................296
D Abbreviation ...............................................................................................................................297

Patient Monitor User Manual Intended Use and Safety Guidance
- 1 -
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate
alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are
intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP),
oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG),
bispectral index (BIS), respiration mechanics (RM) and, impedance cardiography (ICG). Also,
the V-Link module is intended for connecting external devices, such as Neuromuscular
transmission (NMT), Hemodynamic monitoring, Ventilators and Anesthesia devices, to the
monitor, and it allows the data from external devices to be displayed on the monitor.
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
NMT is intended for use on adult and pediatric patients.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.
1.2 Safety Guidance
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
WARNING
1 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
3 Medical technical equipment such as these monitor/monitoring system must only be
used by persons who have received adequate training in the use of such equipment
and who are capable of applying it properly.
4 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth.
5 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
6 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
7 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only EDAN-approved
accessories.
8 Do not come into contact with the patient, table, or the monitor during defibrillation.
9 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.
10 Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment
or MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
11 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
12 Devices connecting with monitor should be equipotential.
13 If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
14 Two batteries must be used when the monitor uses internal power supply.
15 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards. Furthermore all configurations shall
comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody,
who connects additional equipment to the signal input or output connector to
configure a medical system, must make sure that it complies with the requirements of
the valid version of the system standard IEC/EN60601-1. If in doubt, consult our
technical service department or your local distributor.
16 Only use patient cable and other accessories supplied by EDAN. The performance
and electric shock protection cannot be guaranteed, and the patient may be injured
otherwise. Prior to use, check if the casing of a disposable or sterilized accessory is
intact. Do not use it if its casing is damaged.
17 Only recommended batteries can be used for the monitor.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
18 The monitor is equipped with Wi-Fi to receive RF electromagnetic energy. Therefore,
any other equipment complying with CISPR radiation requirements may also interfere
with the wireless communication and make it interrupted.
19 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment
of alarm volume to a low level or off during patient monitoring may result in a hazard
to the patient. Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring equipment.
20 Wireless LAN equipment contains an intentional RF radiator that has the potential of
interfering with other medical equipment, including patient implanted devices. Be sure
to perform the electromagnetic compatibility test, before installation and any time new
medical equipment is added to the Wireless LAN coverage area.
21 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
22 If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
23 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. The settings configured by the user (except Display settings in
12-lead/5-lead) can be stored, and settings not configured by user keep no change.
That is, the last settings used will be recovered when the power is restored.
24 The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose
them together with house-hold garbage. At the end of their life hand the batteries over
to the applicable collection points for the recycling of waste batteries. Inappropriate
disposals of waste may contaminate the environment. For more detailed information
about recycling of this product or battery, please contact your local Civic Office, or the
shop where you purchased the product.
25 The packaging is to be disposed of according to local or hospital’s regulations;
otherwise, it may cause environmental contamination. Place the packaging at the
place which is inaccessible to children.
26 After defibrillation, the ECG display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
27 Clinical decision making based on the output of the device is left to the discretion of
the provider.
28 Do not service or maintain the monitor or any accessory which is in use with the
patient.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
29 Without use of data store function, all data measured (including trend data, review
data, alarm events and so on) are cleared either when the monitor is turned off or
when the monitor is powered down in the process of monitoring.
30 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the
disconnection device.
31 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
32 If leakage or foul odor is detected, ensure that there’s no fire around.
33 Additional multiple socket-outlets or extension cords can’t be connected to the
system.
34 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
35 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall
provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
36 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
37 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
38 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in this user
manual.
39 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.
40 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
41 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
42 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
43 SHOCK HAZARD - Don't connect electrical equipment, which has been supplied as a
part of the system, directly to the wall outlet when the non-medical equipment is
intended to be supplied by a multiple portable socket-outlet with an isolation
transformer.
44 To protect the monitor from damage during defibrillation, for accurate measurement
information and to protect against noise and other interference, use only accessories
specified by EDAN.
45 This equipment is not intended for home usage.
46 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
47 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
48 No modification of this equipment is allowed without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
49 The monitor is suitable for use in the presence of electrosurgery. When the monitor is
used with HF surgical equipment, user (doctor or nurse) should be cautious about
patient safety.
50 Make sure networking function is used in a secure network environment.
51 The device must be connected to the ground to avoid signal interference.
52 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the monitor, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
CAUTION
1 Electromagnetic Interference - Ensure that the environment in which the patient
monitor is installed is not subject to any sources of strong electromagnetic
interference, such as radio transmitters, mobile telephones, microwaves, etc.
2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive
medicine, dust area, high temperature and humid environment.
3 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid
pouring fluids directly on the transducer.