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

X
27.2 Battery Power Indicator ...................................................................................................213
27.3 Battery Status on the Main Screen ...................................................................................213
27.4 Checking Battery Performance ........................................................................................213
27.5 Replacing the Battery.......................................................................................................214
27.6 Recycling the Battery.......................................................................................................214
27.7 Maintaining the Battery....................................................................................................214
Chapter 28 Care and Cleaning .....................................................................................................216
28.1 General Points ..................................................................................................................216
28.2 Cleaning ...........................................................................................................................216
28.2.1 Cleaning the Monitor ............................................................................................217
28.2.2 Cleaning the Reusable Accessories.......................................................................217
28.3 Disinfection......................................................................................................................218
28.3.1 Disinfecting the Monitor.......................................................................................219
28.3.2 Disinfecting the Reusable Accessories..................................................................219
28.4 Cleaning and Disinfecting Other Accessories..................................................................220
Chapter 29 Maintenance ...............................................................................................................221
29.1 Inspecting .........................................................................................................................221
29.2 Maintenance Task and Test Schedule...............................................................................221
Chapter 30 Warranty and Service ................................................................................................223
30.1 Warranty ...........................................................................................................................223
30.2 Contact Information .........................................................................................................223
Chapter 31 Accessories ..................................................................................................................224
31.1 ECG Accessories..............................................................................................................224
31.2 SpO2Accessories .............................................................................................................228
31.3 NIBP Accessories.............................................................................................................229
31.4 TEMP Accessories ...........................................................................................................231
31.5 Quick Temp Accessories* ................................................................................................231
31.6 IBP Accessories................................................................................................................231
31.7 CO2Accessories ...............................................................................................................232
31.8 C.O. Accessories* ............................................................................................................235
31.9 AG Accessories* ..............................................................................................................235
31.10 Other Accessories...........................................................................................................236
A Product Specification .................................................................................................................238
A.1 Classification.....................................................................................................................238
A.2 Physical Specifications......................................................................................................238
A.2.1 Size and Weight......................................................................................................238
A.2.2 Environment Specification.....................................................................................238
A.2.3 Display ...................................................................................................................239
A.2.4 Battery Specification ..............................................................................................239
A.2.5 Recorder .................................................................................................................240
A.2.6 Data Management ..................................................................................................240
A.3 Wi-Fi..................................................................................................................................241
A.3.1 Wi-Fi Technical Specifications ..............................................................................241
A.3.2 Wi-Fi Performance Specifications .........................................................................242
A.4 ECG...................................................................................................................................244

XI
A.5 RESP .................................................................................................................................250
A.6 NIBP..................................................................................................................................250
A.7 SpO2..................................................................................................................................255
A.8 PR......................................................................................................................................256
A.9 TEMP ................................................................................................................................256
A.10 Quick TEMP ...................................................................................................................257
A.11 IBP...................................................................................................................................258
A.12 CO2..................................................................................................................................259
A.13 C.O. .................................................................................................................................269
A.14 AG ...................................................................................................................................269
A.14.1 Sidestream ............................................................................................................269
A.14.2 Mainstream...........................................................................................................278
A.15 Interfaces .........................................................................................................................283
A.15.1 Analog Output ......................................................................................................283
A.15.2 Defibrillator Synchronization...............................................................................284
A.15.3 Nurse Call.............................................................................................................284
A 15.4 USB Interfaces......................................................................................................284
A.15.5 VGA Interface ......................................................................................................285
A.15.6 RS232 Interface....................................................................................................285
A.15.7 Wired Network Interface......................................................................................285
B EMC Information.......................................................................................................................286
B.1 Electromagnetic Emissions ...............................................................................................286
B.2 Electromagnetic Immunity ................................................................................................286
B.3 Electromagnetic Immunity ................................................................................................288
B.4 Recommended Separation Distances ................................................................................291
C Default Settings...........................................................................................................................292
C.1 Patient Information Default Settings .................................................................................292
C.2 Alarm Default Settings ......................................................................................................292
C.3 ECG Default Settings ........................................................................................................292
C.4 RESP Default Settings.......................................................................................................295
C.5 SpO2 Default Settings ........................................................................................................295
C.6 PR Default Settings ...........................................................................................................296
C.7 NIBP Default Settings .......................................................................................................296
C.8 TEMP Default Settings......................................................................................................297
C.9 Quick TEMP Default Settings...........................................................................................297
C.10 IBP Default Settings ........................................................................................................297
C.11 CO2 Default Settings........................................................................................................298
C.12 C.O. Default Settings.......................................................................................................299
C.13 AG Default Settings.........................................................................................................299
D Abbreviations..............................................................................................................................301

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, recording, 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 iM50 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2and Quick Temperature
(Quick TEMP).
The iM60 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (dual-IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2.
The iM70 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (dual-IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2and
Anesthetic gas (AG).
The iM80 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired
CO2and Anesthetic gas (AG).
The M50 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2and Quick Temperature
(Quick TEMP).
The M80 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable),
Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood
pressure (2/4 channels IBP NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired
CO2and Anesthetic gas (AG).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are not intended for MRI environments.

Patient Monitor User Manual Intended Use and Safety Guidance
- 2 -
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 should 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 systems 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 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
5 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth. Never adapt the three-prong
plug from the monitor to fit a two-slot outlet.
6 Do not come into contact with the patient, table, or the monitor during defibrillation.
7 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
8 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.
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 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.
11 Devices connecting with monitor should be equipotential.
12 If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.

Patient Monitor User Manual Intended Use and Safety Guidance
- 3 -
WARNING
13 Do not rely exclusively on the auditory 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.
14 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). 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/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
15 The monitor is equipped with wireless AP/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.
16 Only patient cable and other accessories supplied by EDAN can be used. 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 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
18 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.
19 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 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.
20 If leakage or foul odor is detected, ensure that there’s no fire around.
21 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.
22 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.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
23 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. 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.
24 After defibrillation, the ECG display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
25 Clinical decision making based on the output of the device is left to the discretion of
the provider.
26 This equipment is not intended for home usage.
27 Do not service or maintain the monitor or any accessory which is in use with the patient.
28 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.
29 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
30 The monitors are MR Unsafe. The monitors are not intended for use in an MRI
environment.
31 Only recommended batteries can be used for the monitor.
32 Additional multiple socket-outlets or extension cords can’t be connected to the
system.
33 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.
34 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.
35 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.
36 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
37 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in this user
manual.
38 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.
39 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.
40 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.
41 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.
42 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.
43 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
44 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.
45 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.
46 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.
47 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.
48 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.

Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
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.
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.
4 Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.
5 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
6 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
7 Remove a battery whose life cycle has expired from the monitor immediately.
8 Avoid liquid splashing on the device.
9 To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
10 Before connecting the monitor to the AC power, make sure the voltage and the power
frequency are consistent with the requirements indicated on the device label or in this
user manual.
11 Protect the device against mechanical damage resulting from falls, impacts, and
vibration.
12 Do not touch the touch screen with a sharp object.
13 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
14 The device must be connected to the ground to avoid the signal interference.
15 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.
16 To protect eyes from damage, don't look directly at supplementary light for long time.
17 Extremely frequent clicking on the screen within a short period of time may result in
temporary discontinuous data.

Patient Monitor User Manual Intended Use and Safety Guidance
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CAUTION
18 When multiple parameters are simultaneously displayed and one of the parameter
values is close to the limit value, the waveform might get non-smooth, please take the
parameter value as the reference.
19 If the touch screen fails, use the rotary knob and keys and contact the service
personnel.
NOTE:
1 Position the device in a location where the operator can easily see the screen and
access the operating controls.
2 The monitor can only be used on one patient at a time.
3 If the monitor gets damp or liquid pours on the monitor, please contact the service
personnel of EDAN.
4 This monitor is not a device for treatment purposes.
5 The pictures and interfaces in this manual are for reference only.
6 Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
7 When there's measurement beyond range, invalid measurement or no measurement
value, it will display -?-.
8 In normal use, the operator shall stand in front of the monitor.
1.3 Explanation of Symbols on the Monitor
1
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
2
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
3 Caution
4
MR Unsafe - Keep away from magnetic resonance
imaging (MRI) equipment
5
Equipotentiality
6 Alternating Current

Patient Monitor User Manual Intended Use and Safety Guidance
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7 Power Supply switch
8 Serial Number
9
Network port
10
USB (Universal Serial Bus) Connection
11
Bell cancel
12 NIBP measurement
13
Trend
14 Screen or video image, freeze
15
Graphical recorder
16
Menu
17 Video output
18
RS-232 port
19 Nurse call port
20
Write data into store
21
Defibrillator synchronization/Signal output port