EDAN iM50 User manual

I
About this Manual
P/N: 01.54.457239
MPN: 01.54.457239017
Release Date: July 2020
© Copyright EDAN INSTRUMENTS, INC. 2016-2020. 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 .....................................................................................................................2
1.3 Explanation of Symbols on the Monitor ................................................................................7
Chapter 2 Installation ......................................................................................................................13
2.1 Initial Inspection...................................................................................................................13
2.2 Mounting the Monitor..........................................................................................................13
2.3 Connecting the Power Cable................................................................................................13
2.4 Checking the Monitor ..........................................................................................................13
2.5 Checking the Recorder.........................................................................................................14
2.6 Setting Date and Time..........................................................................................................14
2.7 Handing Over the Monitor...................................................................................................14
2.8 FCC Statement .....................................................................................................................15
2.9 FCC RF Radiation Exposure Statement...............................................................................15
Chapter 3 Basic Operation..............................................................................................................16
3.1 System Components.............................................................................................................16
3.1.1 Front View.................................................................................................................16
3.1.2 Rear View..................................................................................................................19
3.1.3 Side View ..................................................................................................................23
3.2 Operating and Navigating ....................................................................................................25
3.2.1 Using Keys................................................................................................................26
3.3 Operating Mode ...................................................................................................................28
3.3.1 Demo Mode...............................................................................................................28
3.3.2 Standby Mode ...........................................................................................................28
3.3.3 Night Mode ...............................................................................................................29
3.3.4 Privacy Mode ............................................................................................................29
3.3.5 NFC Mode.................................................................................................................29
3.4 Changing Monitor Settings ..................................................................................................30
3.4.1 Adjusting Screen Brightness .....................................................................................30
3.4.2 Changing Date and Time...........................................................................................30
3.5 Adjusting Volume.................................................................................................................31
3.5.1 Adjusting Key Volume ..............................................................................................31
3.5.2 Adjusting Alarm Volume...........................................................................................31
3.5.3 Adjusting Beat Volume..............................................................................................31
3.6 Checking Your Monitor Version ..........................................................................................31
3.7 Setting Languages ................................................................................................................31
3.8 Setting Keyboard Languages ...............................................................................................32
3.9 Calibrating Screens ..............................................................................................................32
3.10 Disabling the Touch Screen................................................................................................32
3.11 Using the Barcode Scanner ................................................................................................32
3.12 Resolving IBP Label Conflicts...........................................................................................33
Chapter 4 Networked Monitoring ..................................................................................................34
4.1 Cybersecurity Measures .......................................................................................................34

IV
4.1.1 Personal Information Safety......................................................................................34
4.1.2 Network Security ......................................................................................................35
4.2 Connecting the Wireless Network........................................................................................36
4.3 Network Disconnected Alarms ............................................................................................38
4.4 Connecting the Monitor to MFM-CMS ...............................................................................38
4.5 Connecting the Monitor to CMS-LITE................................................................................39
4.6 Connecting the Monitor to Gateway....................................................................................39
4.7 HL7 Communication............................................................................................................40
Chapter 5 Alarms .............................................................................................................................41
5.1 Alarm Category ....................................................................................................................41
5.1.1 Physiological Alarms ................................................................................................41
5.1.2 Technical Alarms.......................................................................................................41
5.1.3 Prompts .....................................................................................................................41
5.2 Selecting Alarm Tone Type ..................................................................................................41
5.3 Alarm Levels ........................................................................................................................41
5.4 Controlling Alarm ................................................................................................................43
5.4.1 Setting Parameter Alarm ...........................................................................................43
5.4.2 Audio Alarm Paused..................................................................................................44
5.4.3 Audio Alarm off ........................................................................................................45
5.4.4 Alarm Reset...............................................................................................................45
5.5 Latching Alarms ...................................................................................................................45
5.6 Disabling Sensor Off Alarms ...............................................................................................46
5.7 Testing Alarms......................................................................................................................46
Chapter 6 Alarm Information.........................................................................................................47
6.1 Physiological Alarm Information.........................................................................................47
6.2 Technical Alarm Information ...............................................................................................54
6.3 Prompts ................................................................................................................................70
6.4 Adjustable Range of Alarm Limits.......................................................................................75
Chapter 7 Managing Patients .........................................................................................................79
7.1 Confirming a Patient ............................................................................................................79
7.2 Admitting a Patient...............................................................................................................79
7.2.1 Patient Category and Paced Status............................................................................80
7.3 Quick Admit.........................................................................................................................80
7.4 Barcode Admit .....................................................................................................................80
7.5 Managing Patient Information .............................................................................................81
7.5.1 Editing Patient Information.......................................................................................81
7.5.2 Obtaining Patient Information from the Network Server .........................................81
Chapter 8 User Interface.................................................................................................................83
8.1 Setting Interface Style ..........................................................................................................83
8.2 Selecting Display Parameters...............................................................................................83
8.3 Changing Waveform Position ..............................................................................................83
8.4 Changing Interface Layout...................................................................................................83
8.5 Viewing Trend Screen ..........................................................................................................84
8.6 Viewing OxyCRG Screen ....................................................................................................84
8.7 Viewing Large Font Screen..................................................................................................84

V
8.8 Viewing the Vital Screen......................................................................................................85
8.9 Viewing the Bed View Window ...........................................................................................85
8.9.1 Opening the Bed View Window................................................................................86
8.9.2 Settings of the Bed View Window ............................................................................86
8.10 Changing Parameter and Waveform Colors.......................................................................86
8.11 Displaying the Timer..........................................................................................................86
8.12 Profile.................................................................................................................................87
8.13 Neonatal Configuration*....................................................................................................87
Chapter 9 Monitoring ECG ............................................................................................................88
9.1 Overview ..............................................................................................................................88
9.2 ECG Safety Information ......................................................................................................88
9.3 ECG Display ........................................................................................................................90
9.3.1 Changing the Size of the ECG Wave ........................................................................90
9.3.2 Changing the ECG Filter Settings.............................................................................91
9.4 Selecting Calculation Lead ..................................................................................................91
9.5 Monitoring Procedure ..........................................................................................................92
9.5.1 Preparation ................................................................................................................92
9.5.2 Connecting ECG Cables ...........................................................................................92
9.5.3 Selecting Electrode Type...........................................................................................92
9.5.4 Installing Electrodes..................................................................................................93
9.6 ECG Menu Setup .................................................................................................................97
9.6.1 Setting Alarm Source ................................................................................................97
9.6.2 Setting Beat Source...................................................................................................98
9.6.3 Smart Lead Off..........................................................................................................98
9.6.4 ECG Screen Layout...................................................................................................98
9.6.5 Setting Pace Status ....................................................................................................99
9.6.6 ECG Calibration......................................................................................................100
9.6.7 ECG Waveform Settings .........................................................................................100
9.7 12-Lead ECG Monitoring ..................................................................................................100
9.7.1 Activating 6/10 Electrodes ECG Monitoring..........................................................101
9.7.2 Analysis Function....................................................................................................101
9.7.3 Waveform Durations and Isoelectric Segments ......................................................101
9.8 ST Segment Monitoring.....................................................................................................102
9.8.1 Setting ST Analysis .................................................................................................103
9.8.2 ST Display...............................................................................................................103
9.8.3 About ST Measurement Points................................................................................103
9.8.4 Adjusting ST and ISO Measurement Points............................................................104
9.8.5 ST Alarm Setup .......................................................................................................104
9.8.6 ST View...................................................................................................................104
9.9 Arrhythmia Monitoring ......................................................................................................105
9.9.1 Arrhythmia Analysis................................................................................................105
9.9.2 ARR Analysis Menu................................................................................................110
9.10 QT Analysis......................................................................................................................112
9.10.1 Measurement Limitations......................................................................................112
9.10.2 Switching QT Analysis On and Off ......................................................................113

VI
9.10.3 QT Display............................................................................................................113
9.10.4 Selecting QT Analysis Lead..................................................................................113
9.10.5 Selecting Calculation Formula..............................................................................113
9.10.6 Setting QT Baseline ..............................................................................................114
9.10.7 QTc Alarm Setup...................................................................................................114
9.10.8 QT View ................................................................................................................114
Chapter 10 Monitoring RESP....................................................................................................... 115
10.1 Overview ..........................................................................................................................115
10.2 RESP Safety Information .................................................................................................115
10.3 Electrode Placement for Monitoring RESP ..................................................................... 116
10.4 Cardiac Overlay ...............................................................................................................116
10.5 Chest Expansion...............................................................................................................116
10.6 Abdominal Breathing .......................................................................................................117
10.7 Selecting RESP Lead .......................................................................................................117
10.8 Changing Hold Type ........................................................................................................117
10.9 Changing the Size and Speed of the Respiration Wave ...................................................117
10.10 Changing the Apnea Alarm Time...................................................................................117
Chapter 11 Monitoring SpO2........................................................................................................ 118
11.1 Overview .......................................................................................................................... 118
11.2 SpO2Safety Information ..................................................................................................118
11.3 Measuring SpO2............................................................................................................... 119
11.4 Measurement Limitations.................................................................................................121
11.5 Assessing the Validity of a SpO2Reading........................................................................122
11.6 SpO2Alarm Delay............................................................................................................123
11.7 Perfusion Index (PI)* .......................................................................................................123
11.8 Measuring SpO2and NIBP Simultaneously.....................................................................123
11.9 Setting Pitch Tone ............................................................................................................124
11.10 Setting Sensitivity ..........................................................................................................124
11.11 SatSeconds Alarm Management*...................................................................................124
11.11.1 Describing SatSeconds ........................................................................................124
11.11.2 SatSeconds “Safety Net” .....................................................................................125
11.11.3 Setting SatSeconds Duration ...............................................................................125
Chapter 12 Monitoring PR............................................................................................................126
12.1 Overview ..........................................................................................................................126
12.2 Setting PR Source ............................................................................................................126
12.3 Setting PR Volume ...........................................................................................................126
12.4 Selecting the Active Alarm Source ..................................................................................126
Chapter 13 Monitoring NIBP .......................................................................................................127
13.1 Overview ..........................................................................................................................127
13.2 NIBP Safety Information .................................................................................................127
13.3 Measurement Limitations.................................................................................................128
13.4 Measurement Methods.....................................................................................................129
13.5 Measurement Procedures .................................................................................................130
13.5.1 Operation Prompts ................................................................................................131
13.5.2 Correcting the Measurement if Limb is not at Heart Level ..................................131

VII
13.6 NIBP Multi-Review Window...........................................................................................132
13.7 Resetting NIBP.................................................................................................................132
13.8 Calibrating NIBP..............................................................................................................132
13.9 Leakage Test.....................................................................................................................132
13.10 Setting Inflation Mode ...................................................................................................133
13.11 Cleaning Mode ...............................................................................................................134
13.12 Assisting Venipuncture...................................................................................................134
Chapter 14 Monitoring TEMP......................................................................................................135
14.1 Overview ..........................................................................................................................135
14.2 TEMP Safety Information ................................................................................................135
14.3 Selecting TEMP Sensor Type...........................................................................................135
14.4 Switching T1/T2 On/Off ..................................................................................................135
14.5 TEMP Monitoring Setup ..................................................................................................135
14.6 Selecting a Temperature for Monitoring ..........................................................................136
14.7 Calculating Temp Difference ...........................................................................................136
Chapter 15 Monitoring Quick TEMP ..........................................................................................137
15.1 Overview ..........................................................................................................................137
15.2 Quick TEMP Safety Information .....................................................................................137
15.3 Measuring Procedure .......................................................................................................138
15.3.1 Measurement for Oral Temperature ......................................................................138
15.3.2 Measurements for Rectal Temperatures................................................................139
15.3.3 Measurements for Axillary Temperatures .............................................................139
15.4 Changing Temp Unit ........................................................................................................140
Chapter 16 Monitoring IBP ..........................................................................................................141
16.1 Overview ..........................................................................................................................141
16.2 IBP Safety Information ....................................................................................................141
16.3 Monitoring Procedures.....................................................................................................142
16.3.1 Selecting a Pressure for Monitoring......................................................................142
16.3.2 Zeroing the Pressure Transducer...........................................................................143
16.3.3 Troubleshooting the Pressure Zeroing (Taking Art for Example).........................143
16.3.4 IBP Calibration......................................................................................................143
16.4 Changing the IBP Waveform Ruler..................................................................................144
16.5 IBP Waveform Overlapping .............................................................................................144
16.6 Measuring PAWP .............................................................................................................144
16.6.1 Measurement Procedures ......................................................................................144
16.7 Calculating CPP ...............................................................................................................145
16.7.1 Measurement Procedures ......................................................................................145
16.8 Calculating PPV...............................................................................................................146
Chapter 17 Monitoring CO2..........................................................................................................147
17.1 Overview ..........................................................................................................................147
17.2 CO2Safety Information....................................................................................................147
17.3 Monitoring Procedures.....................................................................................................148
17.3.1 Zeroing the sensor.................................................................................................148
17.3.2 Sidestream CO2Module........................................................................................149
17.3.3 Mainstream CO2Module ......................................................................................157

VIII
17.4 Setting CO2Corrections...................................................................................................159
17.5 Setting Apnea Alarm Time...............................................................................................160
17.6 Setting CO2Waveform.....................................................................................................160
17.7 Intubation Mode...............................................................................................................160
Chapter 18 Monitoring C.O..........................................................................................................162
18.1 Overview ..........................................................................................................................162
18.2 C.O. Safety Information...................................................................................................162
18.3 C.O. Monitoring ...............................................................................................................162
18.4 Blood Temperature Monitoring........................................................................................166
Chapter 19 Monitoring AG ...........................................................................................................167
19.1 Overview ..........................................................................................................................167
19.2 Safety Information ...........................................................................................................167
19.2.1 Safety Information for G7 Module .......................................................................167
19.2.2 Safety Information for Masimo ISA Analyzer ......................................................168
19.2.3 Safety Information for Dräger Minimodule..........................................................170
19.2.4 Safety Information for Masimo IRMA Module....................................................172
19.3 Monitoring Steps..............................................................................................................173
19.3.1 Monitoring Steps for G7 Module ..........................................................................173
19.3.2 Monitoring Steps for Masimo ISA Module ..........................................................175
19.3.3 Monitoring Steps for Dräger Minimodule ............................................................178
19.3.4 Monitoring Steps for Masimo IRMA Module ......................................................179
19.4 Setting Apnea Alarm Time...............................................................................................182
19.5 O2Compensations............................................................................................................182
19.6 Effects of Humidity..........................................................................................................183
Chapter 20 Freeze ..........................................................................................................................184
20.1 Entering/Exiting Freeze Status.........................................................................................184
20.1.1 Entering Freeze Status...........................................................................................184
20.1.2 Exiting Freeze Status.............................................................................................184
20.2 Reviewing Frozen Waveform...........................................................................................185
Chapter 21 Review .........................................................................................................................186
21.1 Trend Graph Review ........................................................................................................186
21.2 Trend Table Review .........................................................................................................187
21.3 NIBP Review....................................................................................................................188
21.4 Alarm Review...................................................................................................................188
21.5 ARR Review ....................................................................................................................188
21.6 12-lead Analysis Review..................................................................................................189
21.7 ST Segment Review.........................................................................................................189
Chapter 22 Calculation..................................................................................................................190
22.1 Drug Calculation ..............................................................................................................190
22.1.1 Calculation Procedures..........................................................................................190
22.1.2 Calculation Unit ....................................................................................................191
22.1.3 Titration Table .......................................................................................................191
22.2 Hemodynamic Calculation...............................................................................................192
22.2.1 Calculation Procedure ...........................................................................................192
22.2.2 Input Parameters....................................................................................................192

IX
22.2.3 Output Parameters.................................................................................................192
22.3 Oxygenation Calculation..................................................................................................193
22.3.1 Calculation Procedure ...........................................................................................193
22.3.2 Input Parameters....................................................................................................194
22.3.3 Output Parameters.................................................................................................194
22.4 Ventilation Calculation.....................................................................................................195
22.4.1 Calculation Procedure ...........................................................................................195
22.4.2 Input Parameters....................................................................................................195
22.4.3 Output Parameters.................................................................................................195
22.5 Renal Function Calculation..............................................................................................196
22.5.1 Calculation Procedure ...........................................................................................196
22.5.2 Input Parameters....................................................................................................196
22.5.3 Output Parameters.................................................................................................197
Chapter 23 Warning-Score System...............................................................................................198
23.1 Warning-Score Interface ..................................................................................................198
23.2 Warning-Score Method ....................................................................................................198
23.3 Warning-Score Criteria ....................................................................................................198
23.4 Warning-Score Result ......................................................................................................200
23.5 Warning-Score Trend Table..............................................................................................200
Chapter 24 Recording....................................................................................................................201
24.1 Performance of the Recorder ...........................................................................................201
24.2 Starting and Stopping Recording .....................................................................................202
24.3 Recorder Operations and Status Messages ......................................................................203
24.3.1 Record Paper Requirement ...................................................................................203
24.3.2 Proper Operation ...................................................................................................204
24.3.3 Paper Out...............................................................................................................204
24.3.4 Replacing Paper ....................................................................................................204
24.3.5 Removing Paper Jam.............................................................................................204
Chapter 25 Printing Patient Reports............................................................................................206
25.1 Printer Settings.................................................................................................................206
25.2 Starting and Stopping Report Printing .............................................................................206
Chapter 26 Other Functions..........................................................................................................208
26.1 Nurse Call.........................................................................................................................208
26.2 Analog Output and Defibrillator Synchronization ...........................................................208
26.3 Storing Data in the Storage Device ..................................................................................208
26.3.1 Data Stored in the Storage Device ........................................................................208
26.3.2 Activating/ Deactivating Data Storing ..................................................................209
26.3.3 Selecting a Storage Device....................................................................................209
26.3.4 Reviewing Data Stored in the Storage Device ......................................................210
26.3.5 Deleting Data Stored in the Storage Device..........................................................210
26.3.6 Exporting Data Stored in the Internal Storage Device..........................................210
26.3.7 Formatting the Internal Storage Device ................................................................211
26.3.8 Ejecting a Removable Device ...............................................................................211
Chapter 27 Using Battery..............................................................................................................212
27.1 Battery Safety Information...............................................................................................212