Manual Monitor Edan

About this Manual
P/N: 01.54.455711-1201
Release Date: August 2013
© Copyright EDAN INSTRUMENTS, INC. 2012-2013. 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.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
I
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.
II
Table of Contents
Chapter 1 Intended Use and Safety Guidance ................................................................................1
1.1 Intended Use...........................................................................................................................1
1.2 Safety Guidance .....................................................................................................................2
1.3 Explanation of Symbols on the Monitor ................................................................................4
Chapter 2 Installation ........................................................................................................................8
2.1 Initial Inspection.....................................................................................................................8
2.2 Mounting the Monitor ............................................................................................................8
2.2.1 Installing Wall Mount for the Monitor........................................................................8
2.3 Connecting the Power Cable..................................................................................................8
2.4 Checking Out the Monitor .....................................................................................................8
2.5 Checking the Recorder...........................................................................................................9
2.6 Setting the Date and Time ......................................................................................................9
2.7 Handing Over the Monitor .....................................................................................................9
2.8 FCC Statement* .....................................................................................................................9
2.9 FCC RF Radiation Exposure Statement*.............................................................................10
Chapter 3 Basic Operation.............................................................................................................. 11
3.1 Overview .............................................................................................................................. 11
3.1.1 Front View.................................................................................................................11
3.1.2 Rear View..................................................................................................................14
3.1.3 Side View ..................................................................................................................18
3.1.4 Configuration ............................................................................................................20
3.2 Operating and Navigating ....................................................................................................20
3.2.1 Using Keys ................................................................................................................22
3.3 Operating Mode ...................................................................................................................23
3.3.1 Demo Mode...............................................................................................................23
3.3.2 Standby Mode ...........................................................................................................24
3.3.3 Night Mode ...............................................................................................................24
3.4 Changing Monitor Settings ..................................................................................................24
3.4.1 Adjusting Screen Brightness .....................................................................................24
III
3.4.2 Changing Date and Time...........................................................................................25
3.5 Adjusting Volume.................................................................................................................25
3.5.1 Adjusting Key Volume ..............................................................................................25
3.5.2 Adjusting Alarm Volume ...........................................................................................25
3.5.3 Adjusting Beat Volume..............................................................................................25
3.6 Checking Your Monitor Version ..........................................................................................25
3.7 Networked Monitoring.........................................................................................................25
3.8 Setting Languages ................................................................................................................26
3.9 Understanding Screens.........................................................................................................26
3.10 Calibrating Screens ............................................................................................................26
3.11 Disabling the Touch Screen................................................................................................26
3.12 Using the Barcode Scanner ................................................................................................27
3.13 Resolving IBP Label Conflicts...........................................................................................27
Chapter 4 Alarms .............................................................................................................................28
4.1 Alarm Category ....................................................................................................................28
4.1.1 Physiological alarms .................................................................................................28
4.1.2 Technical Alarms.......................................................................................................28
4.1.3 Prompts .....................................................................................................................28
4.2 Alarm Levels ........................................................................................................................28
4.3 Controlling Alarm ................................................................................................................29
4.3.1 Setting Parameter Alarm ...........................................................................................29
4.3.2 Temporary Alarm Mute.............................................................................................30
4.3.3 Alarm Mute ...............................................................................................................30
4.3.4 Controlling Alarm Volume ........................................................................................31
4.4 Latching Alarms ...................................................................................................................31
4.5 Disabling Sensor Off Alarms ...............................................................................................31
4.6 Testing Alarms......................................................................................................................31
Chapter 5 Alarm Information.........................................................................................................32
5.1 Physiological Alarm Information.........................................................................................32
5.2 Technical Alarm Information ...............................................................................................37
IV
5.3 Prompts ................................................................................................................................49
5.4 Adjustable Range of Alarm Limits.......................................................................................51
Chapter 6 Managing Patients .........................................................................................................56
6.1 Admitting a Patient...............................................................................................................56
6.1.1 Patient Category and Paced Status ............................................................................56
6.2 Quick Admit .........................................................................................................................57
6.3 Editing Patient Information..................................................................................................57
6.4 Updating a Patient ................................................................................................................57
6.5 Central Monitoring System ..................................................................................................57
Chapter 7 User Interface .................................................................................................................59
7.1 Setting Interface Style ..........................................................................................................59
7.2 Selecting Display Parameters...............................................................................................59
7.3 Changing Waveform Position ..............................................................................................59
7.4 Changing Interface Layout...................................................................................................59
7.5 Viewing Trend Screen ..........................................................................................................59
7.6 Viewing Oxygen Screen.......................................................................................................60
7.7 Viewing Large Font Screen..................................................................................................60
7.8 Viewing the Bed View Window ...........................................................................................61
7.8.1 Opening the Bed View Window................................................................................61
7.8.2 Settings of the Bed View Window ............................................................................61
7.9 Changing Parameter and Waveform Colors.........................................................................61
7.10 User Configuration.............................................................................................................61
7.11 Default Configuration ........................................................................................................62
Chapter 8 Monitoring ECG ............................................................................................................63
8.1 Overview ..............................................................................................................................63
8.2 ECG Safety Information ......................................................................................................63
8.3 ECG Display ........................................................................................................................64
8.3.1 Changing the Size of the ECG Wave ........................................................................64
8.3.2 Changing the ECG Filter Settings.............................................................................65
8.4 Using ECG Alarms...............................................................................................................65
V
8.5 Selecting Calculation Lead ..................................................................................................65
8.6 Monitoring Procedure ..........................................................................................................66
8.6.1 Preparation ................................................................................................................66
8.6.2 Connecting ECG Cables ...........................................................................................66
8.7 Selecting Lead Type .............................................................................................................66
8.8 Installing Electrodes.............................................................................................................66
8.8.1 Electrode Placement for 3-lead .................................................................................67
8.8.2 Electrode Placement for 5-lead .................................................................................68
8.8.3 Electrode Placement for 12-lead ...............................................................................69
8.8.4 Recommended ECG Lead Placement for Surgical Patients......................................70
8.9 ECG Menu Setup .................................................................................................................71
8.9.1 Setting Alarm Source ................................................................................................71
8.9.2 Smart Lead Off..........................................................................................................71
8.9.3 Setting Beat Volume..................................................................................................71
8.9.4 ECG Display .............................................................................................................72
8.9.5 Setting Pace Status ....................................................................................................72
8.9.6 ECG Calibration........................................................................................................72
8.9.7 ECG Waveform Settings ...........................................................................................72
8.9.8 12 Leads ECG ...........................................................................................................73
8.10 ST Segment Monitoring.....................................................................................................73
8.10.1 Setting ST Analysis .................................................................................................73
8.10.2 ST Display...............................................................................................................73
8.10.3 ST Analysis Alarm Setting ......................................................................................73
8.10.4 About ST Measurement Points................................................................................74
8.10.5 Adjusting ST and ISO Measurement Points............................................................74
8.11 Arr. Monitoring...................................................................................................................74
8.11.1 Arrhythmia Analysis................................................................................................74
8.11.2 ARR Analysis Menu................................................................................................76
8.12 12-Lead ECG Monitoring ..................................................................................................77
8.12.1 Diagnosis Function..................................................................................................77
VI
8.12.2 Measurement and Interpretation .............................................................................78
Chapter 9 Monitoring RESP...........................................................................................................79
9.1 Overview ..............................................................................................................................79
9.2 RESP Safety Information .....................................................................................................79
9.3 Resp Display ........................................................................................................................80
9.4 Electrode Placement for Monitoring Resp...........................................................................80
9.5 Cardiac Overlay ...................................................................................................................80
9.6 Chest Expansion...................................................................................................................80
9.7 Abdominal Breathing ...........................................................................................................81
9.8 Selecting Resp Lead.............................................................................................................81
9.9 Changing Hold Type ............................................................................................................81
9.10 Changing the Size of the Respiration Wave.......................................................................81
9.11 Using Resp Alarms.............................................................................................................81
9.12 Changing the Apnea Time..................................................................................................81
Chapter 10 Monitoring SpO2 ..........................................................................................................82
10.1 Overview ............................................................................................................................82
10.2 SpO2 Safety Information ....................................................................................................82
10.3 Measuring SpO2 .................................................................................................................83
10.4 Measurement Procedure.....................................................................................................83
10.5 Understanding SpO2 Alarms ..............................................................................................84
10.6 Adjusting Alarm Limits......................................................................................................84
10.7 Setting SpO2 as Pulse Source.............................................................................................84
10.8 Setting Pitch Tone ..............................................................................................................84
10.9 Setting Sensitivity ..............................................................................................................85
Chapter 11 Monitoring PR ..............................................................................................................86
11.1 Overview ............................................................................................................................86
11.2 Setting PR Source...............................................................................................................86
11.3 Setting PR Volume .............................................................................................................86
11.4 Using Pulse Alarms ............................................................................................................86
11.5 Selecting the Active Alarm Source.....................................................................................86
VII
Chapter 12 Monitoring NIBP .........................................................................................................87
12.1 Overview ............................................................................................................................87
12.2 NIBP Safety Information ...................................................................................................87
12.3 Introducing the Oscillometric NIBP Measurement............................................................88
12.4 Measurement Limitations...................................................................................................88
12.5 Measurement Methods .......................................................................................................89
12.6 Measurement Procedures ...................................................................................................89
12.7 Operation Prompts .............................................................................................................90
12.8 Correcting the Measurement if Limb is not at Heart Level ...............................................90
12.9 NIBP Alarm........................................................................................................................91
12.10 Resetting NIBP.................................................................................................................91
12.11 Calibrating NIBP..............................................................................................................91
12.12 Leak Test ..........................................................................................................................91
12.12.1 Procedure of Leak Test..........................................................................................91
Chapter 13 Monitoring TEMP........................................................................................................93
13.1 Overview ............................................................................................................................93
13.2 TEMP Safety Information ..................................................................................................93
13.3 TEMP Monitoring Setup ....................................................................................................93
13.4 Calculating Temp Difference .............................................................................................93
Chapter 14 Monitoring Quick TEMP* ..........................................................................................94
14.1 Overview ............................................................................................................................94
14.2 Quick TEMP Safety Information .......................................................................................94
14.3 Measuring Procedure .........................................................................................................95
14.3.1 Measurement for Oral Temperature ........................................................................95
14.3.2 Measurements for Rectal Temperatures..................................................................96
14.3.3 Measurements for Axillary Temperatures ...............................................................96
14.4 Changing Temp Unit ..........................................................................................................97
Chapter 15 Monitoring IBP ............................................................................................................98
15.1 Overview ............................................................................................................................98
15.2 IBP Safety Information ......................................................................................................98
VIII
15.3 Monitoring Procedures.......................................................................................................98
15.4 Selecting a Pressure for Monitoring...................................................................................99
15.5 Zeroing the Pressure Transducer........................................................................................99
15.6 Zeroing a Pressure Measurement .....................................................................................100
15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example)....................................100
15.8 IBP Pressure Calibration ..................................................................................................100
15.9 Troubleshooting the Pressure Calibration ........................................................................101
15.10 IBP Alarm.......................................................................................................................102
Chapter 16 Monitoring CO2 ..........................................................................................................103
16.1 Overview ..........................................................................................................................103
16.2 CO2 Safety Information....................................................................................................103
16.3 Monitoring Procedures.....................................................................................................104
16.3.1 Zeroing the sensor .................................................................................................104
16.3.2 Sidestream CO2 Module........................................................................................104
16.3.3 Mainstream CO2 Module ......................................................................................106
16.4 Setting CO2 Waveform Setup...........................................................................................108
16.5 Setting CO2 Corrections...................................................................................................108
16.6 Changing CO2 Alarms......................................................................................................109
16.7 Changing the Apnea Alarm Delay....................................................................................109
Chapter 17 Monitoring C.O. ......................................................................................................... 110
17.1 Overview .......................................................................................................................... 110
17.2 C.O. Safety Information................................................................................................... 110
17.3 C.O. Monitoring Procedures ............................................................................................ 110
17.4 C.O. Measurement Window............................................................................................. 111
17.5 Measurement Process.......................................................................................................113
17.6 Editing C.O. ..................................................................................................................... 114
17.7 Blood Temperature Monitoring........................................................................................ 114
17.8 Setting the Computation Constant ...................................................................................115
17.9 Recording C.O. Measurements ........................................................................................115
17.10 Setting INJ. TEMP Source .............................................................................................115
IX
Chapter 18 Monitoring AG ........................................................................................................... 116
18.1 Overview .......................................................................................................................... 116
18.2 Safety Information ........................................................................................................... 116
18.2.1 Safety Information for ISA Analyzer ....................................................................116
18.2.2 Safety Information for IRMA Module ..................................................................118
18.3 Monitoring Steps.............................................................................................................. 119
18.3.1 Monitoring Steps for ISA Analyzer.......................................................................119
18.3.2 Monitoring Steps for IRMA Module.....................................................................121
18.4 Setting Work Mode ..........................................................................................................124
18.5 Setting Alarms..................................................................................................................125
18.6 Setting Apnea Alarm Time ...............................................................................................125
18.7 Working Status of ISA analyzer .......................................................................................125
18.8 Working Status of IRMA Module ....................................................................................125
18.9 N2O and O2 Compensations .............................................................................................126
18.10 Effects of humidity.........................................................................................................126
Chapter 19 Freeze ..........................................................................................................................127
19.1 Overview ..........................................................................................................................127
19.2 Entering/Exiting Freeze Status.........................................................................................127
19.2.1 Entering Freeze Status...........................................................................................127
19.2.2 Exiting Freeze Status.............................................................................................127
19.3 Reviewing Frozen Waveform...........................................................................................128
Chapter 20 Review .........................................................................................................................129
20.1 Trend Graph Review ........................................................................................................129
20.1.1 Selecting Trend Graph of Specific Parameter.......................................................129
20.1.2 Adjusting Trend Scale ...........................................................................................129
20.1.3 Setting Resolution .................................................................................................130
20.1.4 Scrolling Left and Right the Screen ......................................................................130
20.1.5 Switching to the Trend Table ................................................................................130
20.1.6 Record ...................................................................................................................130
20.2 Trend Table Review .........................................................................................................130
X
20.2.1 Setting Resolution .................................................................................................130
20.2.2 Scrolling the Screen ..............................................................................................130
20.2.3 Switching to Trend Graph .....................................................................................131
20.2.4 Recording ..............................................................................................................131
20.3 NIBP Review....................................................................................................................131
20.3.2 Recording ..............................................................................................................131
20.4 Alarm Review...................................................................................................................131
20.4.2 Selecting Alarm Event of Specific Parameter.......................................................132
20.4.3 Setting Time Index ................................................................................................132
20.5 Arr Review .......................................................................................................................132
20.6 12-lead Diagnosis Review................................................................................................133
20.6.2 Deleting Diagnosis Results ...................................................................................133
20.6.3 Switching Between Waveforms and Results.........................................................133
20.6.4 Recording ..............................................................................................................133
Chapter 21 Calculation and Titration Table................................................................................134
21.1 Drug Calculation ..............................................................................................................134
21.1.1 Calculation Procedures..........................................................................................134
21.1.2 Calculation Unit ....................................................................................................135
21.2 Titration Table ..................................................................................................................135
21.3 Hemodynamic Calculation...............................................................................................136
21.3.1 Calculation Procedure ...........................................................................................136
21.3.2 Input Parameters....................................................................................................136
21.3.3 Output Parameters.................................................................................................136
Chapter 22 Recording....................................................................................................................138
22.1 General Information .........................................................................................................138
22.2 Performance of the Recorder ...........................................................................................138
XI
22.3 Recording Type ................................................................................................................139
22.4 Starting and Stopping Recording .....................................................................................139
22.5 Recorder Operations and Status Messages ......................................................................140
22.5.1 Record Paper Requirement ...................................................................................140
22.5.2 Proper Operation ...................................................................................................140
22.5.3 Paper Out...............................................................................................................141
22.5.4 Replacing Paper ....................................................................................................141
22.5.5 Removing Paper Jam.............................................................................................142
Chapter 23 Other Functions..........................................................................................................143
23.1 Nurse Call.........................................................................................................................143
23.2 Analog Output and Defibrillator Synchronization ...........................................................143
23.3 Storing Data in a Removable Device ...............................................................................143
23.3.1 Data Stored in the Removable Device ..................................................................143
23.3.2 Activating/ Deactivating Data Storing ..................................................................144
23.3.3 Selecting a Removable Device..............................................................................144
23.3.4 Reviewing Data Stored in a Removable Device ...................................................144
23.3.5 Deleting Data Stored in a Removable Device.......................................................144
23.3.6 Ejecting a Removable Device ...............................................................................145
Chapter 24 Using Battery ..............................................................................................................146
24.1 Battery Power Indicator ...................................................................................................146
24.2 Battery Status on the Main Screen ...................................................................................146
24.3 Checking Battery Performance ........................................................................................146
24.4 Replacing the Battery.......................................................................................................147
24.5 Recycling the Battery.......................................................................................................148
24.6 Maintaining the Battery....................................................................................................148
Chapter 25 Care and Cleaning .....................................................................................................149
25.1 General Points ..................................................................................................................149
25.2 Cleaning ...........................................................................................................................149
25.2.1 Cleaning the Monitor ............................................................................................149
25.2.2 Cleaning the Accessories.......................................................................................150
XII
25.3 Disinfection ......................................................................................................................151
Chapter 26 Maintenance ...............................................................................................................152
26.1 Inspecting .........................................................................................................................152
26.2 Maintenance Task and Test Schedule...............................................................................152
Chapter 27 Warranty and Service................................................................................................154
27.1 Warranty ...........................................................................................................................154
27.2 Contact information .........................................................................................................154
Chapter 28 Accessories ..................................................................................................................155
28.1 ECG Accessories..............................................................................................................155
28.2 SpO2 Accessories .............................................................................................................157
28.3 NIBP Accessories.............................................................................................................158
28.4 Temp Accessories.............................................................................................................160
28.5 Quick Temp Accessories* ................................................................................................160
28.6 IBP Accessories................................................................................................................160
28.7 CO2 Accessories ...............................................................................................................161
28.8 C.O. Accessories* ............................................................................................................162
28.9 AG Accessories* ..............................................................................................................162
28.10 Other Accessories...........................................................................................................163
A Product Specification .................................................................................................................165
A.1 Classification.....................................................................................................................165
A.2 Physical Specifications......................................................................................................165
A.2.1 Size and Weight......................................................................................................165
A.2.2 Environment Specification.....................................................................................165
A.2.3 Display ...................................................................................................................166
A.2.4 Battery Specification ..............................................................................................167
A.2.5 Recorder .................................................................................................................167
A.2.6 Data Storage ...........................................................................................................168
A.3 ECG...................................................................................................................................168
A.4 RESP .................................................................................................................................173
A.5 NIBP..................................................................................................................................174
XIII
A.6 SpO2 ..................................................................................................................................176
A.7 TEMP ................................................................................................................................177
A.8 Quick TEMP .....................................................................................................................177
A.9 IBP.....................................................................................................................................177
A.10 CO2 ..................................................................................................................................178
A.11 C.O. .................................................................................................................................181
A.12 AG ...................................................................................................................................182
A.12.1 Phasein Sidestream...............................................................................................182
A.12.2 Phasein Mainstream .............................................................................................184
B EMC Information.......................................................................................................................188
B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS.................................188
B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS .................................188
B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING................................................................................................................190
B.4 Recommended Separation Distances ................................................................................191
C Default Settings...........................................................................................................................193
C.1 Patient Information Default Settings .................................................................................193
C.2 Alarm Default Settings ......................................................................................................193
C.3 ECG Default Settings ........................................................................................................193
C.4 RESP..................................................................................................................................195
C.5 SpO2 ...................................................................................................................................195
C.6 PR ......................................................................................................................................195
C.7 NIBP ..................................................................................................................................196
C.8 TEMP ................................................................................................................................196
C.9 Quick TEMP......................................................................................................................197
C.10 IBP...................................................................................................................................197
C.11 CO2 ..................................................................................................................................198
C.12 C.O...................................................................................................................................198
C.13 AG....................................................................................................................................199
D Abbreviations..............................................................................................................................200
XIV
Patient Monitor User Manual Intended Use and Safety Guidance
Chapter 1 Intended Use and Safety Guidance

1.1 Intended Use
The iM50 patient monitor is intended to be used for monitoring, storing, reviewing, recording,
and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in
hospital environments. The monitored physiological parameters include: ECG, respiration
(RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and quick temperature
(Quick TEMP). This monitor is suitable for use in intra-hospital transport and hospital
environments including clinic, emergency department, wards, PACU and NICU.
pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and cardiac output (C.O.).
This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and
wards.
pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and
anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU,
NICU, PACU and wards.
pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and
anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU,
NICU, PACU and wards.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
-1-
1.2 Safety Guidance

WARNING
1 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.
2 Medical technical equipment such as these monitor/monitoring system must only be
used by persons who have received adequate training in the use of such equipment
and who are capable of applying it properly.
3 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
4 SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the monitor to
fit a two-slot outlet.
5 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.
6 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.
7 Route all cables away from patient’s throat to avoid possible strangulation.
8 Devices connecting with monitor should be equipotential.
9 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 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN60601-1-1. If in doubt,
consult our technical service department or your local distributor.
10 Only patient cable and other accessories supplied by EDAN can be used. Or else, the
performance and electric shock protection cannot be guaranteed, and the patient may
be injured.
-2-
WARNING
11 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment
of alarm volume to a low level or off during patient monitoring may result in a hazard
to the patient. Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring equipment.
12 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
13 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off, and only the patient information and alarm settings can be saved.
After reconnecting the power supply, the user should turn on the monitor for
monitoring.
14 Keep away from fire immediately when leakage or foul odor is detected.
15 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.
16 Dispose of the package material, observing the waste control regulations and keeping
it out of children’s reach.
17 After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
18 This equipment is not intended for family usage.
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, 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 could 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.
-3-
CAUTION
7 Remove a battery whose life cycle has expired from the monitor immediately.
8 Avoid liquid splash on the device. The temperature must be kept between 5qC and
40qC while working. And it should be kept between -20qC and 55qC during
transportation and storage.
9 To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
10 Federal (U.S.) law restricts this device to sale by or on the order of a physician.
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 The monitor may not be compatible with all models of USB flash drives. Use the USB
flash drives that are recommended by EDAN.
8 It is recommended to format the USB flash drive to the FAT file type via PC prior to
use.
1.3 Explanation of Symbols on the Monitor

This symbol indicates that the equipment is IEC/EN60601-1 Type CF
equipment. The unit displaying this symbol contains an F-Type
isolated (floating) patient applied part providing a high degree of
protection against shock, and is suitable for use during defibrillation.
This symbol indicates that the instrument is IEC/EN 60601-1 Type

BF equipment. The unit displaying this symbol contains an F-Type
isolated (floating) patient applied part providing a high degree of
protection against shock, and is suitable for use during defibrillation.
Symbol for “Caution”
-4-
Equipotential grounding terminal
Alternating Current
Power Supply switch
Serial number
Network port
USB (Universal Serial Bus) Connection
Audio alarm is off
NIBP measurement
Trend graph
Freeze
Record
Menu
VGA output, External Monitor
-5-
RS-232 port
Nurse call port
SD Card port
Signal output port
Signal output
The symbol indicates that the device complies with the European
Council Directive 93/42/EEC concerning medical devices.
Authorized representative in the European community
Date of manufacture
Manufacturer
P/N Part Number
Recycle
The symbol indicates that the device should be sent to the special
agencies according to local regulations for separate collection after
its useful life.
Consult Instructions For Use
-6-
Locked position
Gas inlet
Gas outlet (evac)
ISA equipped to measure CO2 only.
ISA equipped to measure multiple gases.
Federal (U.S.) Law restricts this device to sale by or on the order of a

physician.
(Only applicable to iM50 and iM80) With respect to electrical shock,

fire and mechanical hazards only in accordance with UL 60601-1and
CAN/CSA C22.2 No. 601.1, IEC 60601-2-25*, IEC 60601-2-27,
IEC 60601-2-30,IEC 60601-2-34, IEC 60601-2-49, IEC
60601-2-51* (Symbol * means this standard only applicable to
iM80)
-7-
Patient Monitor User Manual Installation
Chapter 2 Installation
NOTE:
1 The monitor settings must be specified by the authorized hospital personnel.
2 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2.1 Initial Inspection

Before unpacking, check the packaging and ensure that there are no signs of mishandling or
damage. If the shipping cartons are damaged, contact the carrier for compensation and package
them again.
Open the package carefully and remove the monitor and accessories. Check that the contents are
complete and that the correct options and accessories have been delivered.
If you have any question, please contact your local supplier.
2.2 Mounting the Monitor

If all situations are normal, please place the monitor on a flat, level surface, hung on the bed rail,
or mounted on a wall. About how to install the wall mount for the monitor, please refer to the
following content.
2.2.1 Installing Wall Mount for the Monitor

For how to install wall mount for the monitor, please refer to Wall Mounting Bracket Assembly
Instruction.
2.3 Connecting the Power Cable
Connection procedure of the AC power line is listed below:
1 Make sure the AC power supply complies with the following specifications: 100V-240V~,
50Hz/60Hz.
2 Apply the power line provided with the monitor. Plug the power line to inlet interface of the
monitor. Connect the other end of the power line to a grounded 3-phase power output.
NOTE:
Connect the power line to the jack special for hospital usage.
2.4 Checking Out the Monitor

Make sure there is no damage on the measurement accessories and cables. Then turn on the
monitor, check whether the monitor can start normally. Make sure all alarm lamps light up and
the alarm sound is heard when turning on the monitor.
-8-
WARNING
If any sign of damage is detected, or the monitor displays some error messages, do not
use it on any patient. Contact Customer Service Center immediately.
NOTE:
1 Check all the functions of the monitor and make sure that the monitor is in good
status.
2 If rechargeable batteries are provided, charge them after using the device every time,
to ensure the electric power is enough.
3 The interval between double pressing of POWER switch should be longer than 1
minute.
4 After continuous 360-hour runtime, please restart the monitor to ensure the monitor’s
steady performance and long lifespan.
2.5 Checking the Recorder

If your monitor is equipped with a recorder, open the recorder’s door to check if paper is properly
installed in the slot. If no paper exists, refer to Chapter Recording for details.
2.6 Setting the Date and Time

To set the date and time:
1. Select Menu > Maintenance > User Maintain > Date/Time Setup.
2. Adjust the date display format based on the user’s habit.
3. Set the correct time of year, month, day, hour, min and sec.
2.7 Handing Over the Monitor

If you are handing over the monitor to the end-users directly after configuration, make sure that it
is in the monitoring mode.
The users must be adequately trained to use the monitor before monitoring a patient. To achieve
this, they should have access to, and read, the following documentation delivered with the
monitor:
z User Manual (this book) - for full operating instructions.
z Quick Reference Card - for quick reminders during use.
2.8 FCC Statement*

*The statement is not applicable to iM50 or iM80.
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
-9-
cause harmful interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
1. Reorient or relocate the receiving antenna.
2. Increase the separation between the equipment and receiver.
3. Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
4. Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of FCC Rules.
Operation is subject to the following two conditions:

1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause
undesired operation.
NOTE:
The manufacturer is not responsible for any radio or TV interference caused by
unauthorized modifications to this equipment. Such modifications could void the user’s
authority to operate this equipment.
2.9 FCC RF Radiation Exposure Statement*

*The statement is not applicable to iM50 or iM80.
This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with a minimum distance of 20
centimeters between the radiator and your body.
- 10 -
Patient Monitor User Manual Basic Operation
Chapter 3 Basic Operation

This manual is for clinical professionals using the iM50/iM60/iM70/iM80 patient monitors.
Unless otherwise specified, the information here is valid for all the above products.
This user manual describes all features and options. Your monitor may not have all of them; they
are not all available in all geographies. Your monitor is highly configurable. What you see on the
screen, how the menus appear and so forth, depend on the way it has been tailored for your
hospital and may not be exactly as shown here.
3.1 Overview
3.1.1 Front View
2
10
00
3 4 5 6 7 8 9
iM50
- 11 -
2 10
3 4 5 6 7 8 9
iM60
2 10
3 4 5 6 7 8 9
iM70
- 12 -
2 10
3 4 5 6 7 8 9
iM80
1 Alarm indicator — when an alarm occurs, the alarm indicator will light
or flash. The color of light represents the alarm level.
2 Power supply switch — when the monitor is connected to the AC power
supply, press the key to turn the monitor on. When the monitor is turned
on, press the key to turn the monitor off.
3 Battery indicator, refer to Section Battery Indicator for details.
4 Mute — Press this button to pause the alarm. All the audio alarm will be
closed. At the same time, the message of Temporary Alarm Mute **s
and the symbol will be displayed in the information area. When you
repress it or the pause time is over, the system will resume the normal
monitoring status and the message of Temporary Alarm Mute **s and
icon will vanish. Symbol is shown in the information area. Pressing
or holding the button again can resume the alarm.
Further Alarm Mute information can be found in the chapter Alarm
Mute.
5 Start / Stop NIBP measurement — Press this button to inflate the cuff
and start blood pressure measurement. During the measurement, press the
button to stop the measurement.
6 Trend Key — Press this button to enter trend table review interface.
7 Freeze /Unfreeze — In normal mode, press this button to freeze all the
waveforms on the screen. In Freeze mode, press this button to restore the
waveform refreshing.
- 13 -
8 Start / Stop Recording — Press this button to start a real-time recording.

During the recording, press this button again to stop recording.
9 Menu — Press this button to return to the main interface when there is no
menu open.
10 Rotary Knob (hereinafter called knob) — The user can rotate the knob
clockwise or anticlockwise. This operation can make the highlighted item
shift up, down, left or right to choose the desired item. Remember, when
using the knob, rotate this button to highlight, and press it to select the
item.
3.1.2 Rear View
2 10
3
4
11
5 6 7 8 9
iM50
1 Equipotential grounding terminal, if the monitor or other processing

unit are used in internal examinations on the heart, ensure that the room
incorporates an equipotential grounding system to which the monitor
and other processing unit have separate connection.
2 Fan
3 Anti-theft lock interface
4 Security lock, used to prevent the power supply cord from falling.
5 Power Supply Inlet
6 USB interface, this port is used to connect the USB device.
- 14 -
7 VGA Interface
8 Network interface, this port is used to connect to the central monitoring
system through the standard network wire.
9 Defibrillator synchronization / analog output. When the user selects
Analog Output, the monitor outputs the waveform through the
auxiliary output port. When the user selects Defibrillation the monitor
outputs the defibrillator synchronization signal through the auxiliary
output port.
10 Speaker
11 SD Card
2 8
4 9
5 10
11
6 7
iM60/iM70
1 SD Card
3 Network interface, this port is used to connect to the central
monitoring system through the standard network wire.
4 VGA output
- 15 -
5 Defibrillator synchronization/ analog output/ nurse call port:

When the user selects Analog Output, the monitor outputs the
waveform through the auxiliary output port. When the user
selects Defibrillation, the monitor outputs the defibrillator
synchronization signal through the auxiliary output port. When
the port is used as nurse call port, it is connected to the call
system. When there is an alarm, the monitor outputs nurse call
signal to notify the nurse.
7 Heat sink
8 Speaker
9 Equipotential grounding terminal, if the monitor or other
processing unit are used in internal examinations on the heart,
ensure that the room incorporates an equipotential grounding
system to which the monitor and other processing unit have
separate connection.
10 Power Supply Inlet
1 13
2
3
12
4
5 11
6 7 9 10
8
iM80
- 16 -
1 SD Card
2 Nurse call port, this port is connected to the call system. When
there is an alarm, the monitor outputs nurse call signal to notify
the nurse.
3 Defibrillator synchronization / analog output. When the user
selects Analog Output, the monitor outputs the waveform
through the auxiliary output port. When the user selects
Defibrillation, the monitor outputs the defibrillator
synchronization signal through the auxiliary output port.
4 VGA output
6 RS232 interface
7 Network interface, this port is used to connect to the central
monitoring system through the standard network wire.
9 Heat emission hole
11 Equipotential grounding terminal, if the monitor or other
processing unit are used in internal examinations on the heart,
ensure that the room incorporates an equipotential grounding
system to which the monitor and other processing unit have
separate connection.
12 Speaker
13 Fan
- 17 -
3.1.3 Side View
1
3
2 4
iM50
1 Sensor interface
2 CO2 module holder
3 Recorder door
4 Battery door
2 4
iM60/iM70
- 18 -
1 Sensor port
2 CO2 module holder
3 Recorder door
4 Battery door
1 3
2 4
iM80
1 Sensor port
2 AG module holder
3 Recorder door
4 Battery door
- 19 -
3.1.4 Configuration
Model Size (L×W×H) Function Configuration
ECG, RESP, SpO2, NIBP,
iM50 261 mm (L) × 198 mm (W) × 215 mm (H) IBP ,TEMP, Quick TEMP,
CO2
iM60 303mm(L) × 161mm(W) × 254mm(H)
TEMP, IBP, C.O., CO2
iM70 328mm(L) × 158mm(W) × 285mm(H) TEMP, IBP, C.O., CO2,
AG
iM80 370 mm (L) × 175 mm (W) × 320 mm (H) TEMP, IBP, C.O., CO2,
AG
3.2 Operating and Navigating

Everything you need to operate the monitor is contained on its screen. Almost every element on
the screen is interactive. Screen elements include measurement data, waveforms, screen keys,
information fields, alarms fields and menus. The configurability of the monitor means that often
you can access the same element in different ways. For example, you might be able to access an
item through its on-screen setup menu, via a hard key, or via a shortcut key. The User Manual
always describes how to access items via an on-screen menu. You may use whichever way you
find most convenient.
- 20 -
1 Department
2 Bed number
3 Patient name
4 Patient type
5 Alarm status area
6 Alarm off
7 Measurement value
8 Menu
9 Date and time
10 Scroll right to display more shortcut keys
11 Networking symbol
12 Battery status symbol
13 AC power supply symbol
- 21 -
14 Shortcut key area

15 Scroll left to display more shortcut keys
16 Mute key
17 Parameter waveform
3.2.1 Using Keys

The monitor has four different types of keys:
3.2.1.1 Permanent Keys
A permanent key is a graphical key that remains on the screen all the time to give you fast access
to functions.
Menu – enter the main setup menu.
Mute key – close the audio alarm to switch off the alarm.
3.2.1.2 Shortcut Keys
A shortcut key is a configurable graphical key, located at the bottom of the main screen. It gives
you fast access to functions. The selection of shortcut keys available on your monitor depends on
your monitor configuration and on the options purchased.
Perform a 12-lead analysis Switch to the standard screen
Exit from 12-lead analysis Switch to the OxyCRG screen
Access the 12-lead review Switch to the large font screen
Perform 12-lead record Set the module switch
Admit a patient Change the key volume
Review the trend graph Adjust the screen brightness
- 22 -
Review the trend table Zero the IBP sensor
Review the alarm event Alarm setup
Access the NIBP review Change the beat volume
Access the ARR review Enter standby mode
Switch to the trend screen Enter night mode
Select this item by the trim knob to enable the touch screen operation
3.2.1.3 Hardkeys
A hardkey is a physical key on a monitoring device, such as the recording key on the front panel.
3.2.1.4 Pop-up keys
Pop-up keys are task-related graphical keys that appear automatically on the screen when
required. For example, the confirmation pop-up key appears only when you need to confirm a
change.
3.3 Operating Mode

3.3.1 Demo Mode
To change the operating mode into the demo mode, please refer to the following procedure:
Select Menu > Common Function, then choose Demo Mode from the popup interface and input
password 3045.
After entering Demo Mode, the monitor will perform the followings:
z Storing no data of new patient.
z Pausing to give all types of alarm.
z Pausing to transmit patient data to CMS and other network devices.
z Pausing to store the currently recorded data, and clearing the memory used to store
recording and printing data.
- 23 -
z Real data: the parameter measurement value and real waveform displayed on the screen
are from the predefined analog data, not the truly monitoring patients’ data.
z History data: the monitor will store the analog real-time data in Demo mode, including
trend data, patient information, alarm event, waveform and setting.
To exit Demo Mode, select Menu > Common Function > Demo Mode to exit.
WARNING
This is for demonstration purposes only. You must not change into Demo Mode during
monitoring. In Demo Mode, all stored trend information is deleted from the monitor’s
memory.
3.3.2 Standby Mode

Standby mode can be used when you want to temporarily interrupt monitoring. To enter standby
mode, please press the shortcut key on the screen directly. To resume monitoring, select
anything on the screen or press any key.
3.3.3 Night Mode

To switch to night mode, you may:
z Select the shortcut key on the main screen, or

z Select Menu> Common Function> Night Mode.
NOTE:
In night mode, the sound of key, heart beat and pulse is muted; the alarm volume and
screen brightness are down to their minimum; the settings including key volume, beat
volume, PR volume, alarm volume and screen brightness are unavailable.
3.4 Changing Monitor Settings

3.4.1 Adjusting Screen Brightness
To change the screen brightness, please:
1. Press the Brightness key on the screen directly or.
2. Select Menu > Common Function > Brightness, and select the appropriate setting for the
screen brightness. 10 is the brightest, 1 is the least bright.
Your monitor may be configured with lower brightness in standby mode and also for transport to
conserve battery power.
- 24 -
3.4.2 Changing Date and Time

To change the date and time, please refer to Section Setting Date and Time.
WARNING
Change to date and time will influence the storage of trend data.
3.5 Adjusting Volume

3.5.1 Adjusting Key Volume
The key volume is the volume you hear when you select any field on the monitor screen or when
you turn the knob. To adjust the key volume, please:
1. Select the Key Volume key on the screen directly or.
2. Select Menu > System Setup > Key Volume, then select the appropriate setting for the key
volume: Five is the loudest and Zero is the quietest.
3.5.2 Adjusting Alarm Volume

To change the alarm volume, please
1. Press the Alarm Volume key on the screen directly or.
2. Select Menu > Alarm Setup > Alarm Volume, and select the desired setting from the
popup interface. For detailed information, please refer to Section Controlling Alarm Volume.
3.5.3 Adjusting Beat Volume

To change the beat volume, please press the Beat Volume key on the screen directly or refer to
Section Setting Beat Volume.
3.6 Checking Your Monitor Version

To check the monitor version, please select Menu > Common Function > About to check the
monitor software revision.
3.7 Networked Monitoring

Your monitor can be connected to the wired network. If the monitor is networked, a network
symbol is displayed on the screen.
- 25 -
3.8 Setting Languages

To change the language, please:
1. Select Menu > Maintenance > User Maintain, then type the correct password ABC into the
displayed interface.
2. Select the Language option on the popup interface to open the language list.
3. Select the desired language from the list. To make the change validate, please restart the
monitor.
3.9 Understanding Screens

Your monitor comes with a set of preconfigured screens, optimized for common monitoring
scenarios such as OR adult, or ICU neonatal. A screen defines the overall selection, size and
position of waves, numeric and shortcut keys on the monitor screen when you switch on the
monitor. You can easily switch between different screens during monitoring. Screens do NOT
affect alarm settings, patient category and so forth. When you switch from a complex to a less
complex screen layout, some measurements may not be visible but are still monitored in the
background. For detailed information, please refer to Chapter User Interface.
3.10 Calibrating Screens

To calibrate the screen, please refer to the following steps:
1. Select Menu > Maintenance > User Maintain, then input maintenance password ABC,
then select TouchScr Calibration from the popup interface.
2. The symbol appears on the screen.
3. Click on the central point of the symbol .

4. After successful calibration, the message of Screen Calibration Completed appears on the
screen. Then select Exit to finish the calibration.
3.11 Disabling the Touch Screen

The user can disable touch screen operation by pressing and holding the Menu shortcut key for 3
seconds. A message of Screen Locked and the symbol are displayed at the bottom of screen
if the touch screen is disabled. To enable the touch screen operation, turn the knob to select the
symbol and press it.
- 26 -
3.12 Using the Barcode Scanner

To enter the barcode setup menu, please select Menu > Maintenance > User Maintain, after
entering the required password ABC, select Other Setup > BarCode Setup. Then the user can
set serial No, last Name, first Name and so on.
If Auto Update is set to On, the patient information is updated automatically by using a bar code
scanner. If Auto Update is set to Off, the user needs to update the patient information manually.
3.13 Resolving IBP Label Conflicts

Each label must be unique and can only be assigned once. The measurement labels are stored in
the measurement modules. If you try to use two IBP channels that have identical labels, this
causes a label conflict in the monitor.
For example, an IBP channel (channel A) has already been loaded and the label Art is used for
channel A. Then another IBP channel (channel B) is loaded and the label Art is also used for
channel B. In this case, a label conflict will be triggered. A prompt indicating IBP label conflict
will appear on the left of the screen. Additionally, at the corresponding measurements area, a
label flickers to indicate a label conflict. The flickering label is the default one assigned by the
system.
The IBP channel with a label conflict will not provide any measurement data; besides, the
functions of setup, zeroing and calibrating are unavailable. To resolve the label conflict, you have
to change the conflicting label into a non-conflicting one via the following method:
1 Select the IBP channel with a label conflict on the screen and open the Options menu.
2 Choose another label among the options from the Alias pull-down list to resolve the label
conflict.
- 27 -
Patient Monitor User Manual Alarms
Chapter 4 Alarms
The alarm information here applies to all measurements. Measurement-specific alarm
information is discussed in the sections of individual measurements.
WARNING
A potential hazard can exist if different alarm presets are used for the same or similar
equipment in any single area, e.g. an intensive care unit or cardiac operating room.
4.1 Alarm Category

The monitor provides two types of alarms: physiological alarms and technical alarms.
4.1.1 Physiological alarms

If one or several physiological parameters of the currently monitored patient exceed the
predefined alarm limit, for example: SpO2 values exceed the alarm limit, the monitor will give an
alarm, and this type of alarm is called physiological alarms. About the detailed alarm information,
please refer to the Section physiological alarm information.
4.1.2 Technical Alarms

If one or several technical status of the device is in abnormal status, such as: lead off or low
battery and so on, the monitor will give an alarm. And this type of alarm is called technical
alarms. About the detailed alarm information, please refer to Section technical alarm
information.
4.1.3 Prompts
The monitor can give the character indication of monitoring process or other functions, such as:
ARR Relearning and so on. And this character is called prompts. About the detailed alarm
information, please refer to Section Prompts.
4.2 Alarm Levels

In terms of severity, the device’s alarm levels can be classified into three categories: high level
alarms, medium level alarms and low level alarms.
1. High level alarms
Indicating that the patient is in a life threatening situation and an emergency treatment is
demanded.
2. Medium level alarms
The patient’s vital signs appear abnormally or the device system status is abnormal,
indicating that prompt operator response is required.
- 28 -
3. Low level alarms

The patient’s vital signs appear abnormal or the device system status appears abnormally,
indicating that operator awareness is required.
The high/medium/low-level alarms are indicated by the system in following different ways:
Alarm Physiological alarms Technical alarms
Prompt
level
The alarm indicator The alarm indicator
Mode is flashes in red, with a flashes in red. The alarm
“DO-DO-DO------DO- frequency of 1.4Hz ̚ message flashes with red
High DO, 2.8Hz.The alarm background, and the
DO-DO-DO------DO-D message flashes with red symbol *** is displayed at
O”, which is triggered background, and the the alarm area.
once every 10 seconds. symbol *** is displayed at
the alarm area.
The alarm indicator No definition
flashes in yellow, with a
frequency of 0.4Hz ̚
Mode is “DO-DO-DO”, 0.8Hz. The alarm
Medium which is triggered once message flashes with
every 25 seconds. yellow background, and
the symbol ** is
displayed at the alarm
area.
The alarm indicator The alarm indicator
flashes in yellow. The flashes in blue. The alarm
Mode is “DO-”, which alarm message flashes message flashes with
Low is triggered once every with yellow background, yellow background, and
30 seconds. and the symbol * is the symbol * is displayed
displayed at the alarm at the alarm area.
area.
The sound pressure range for audible alarm signals is from 45 dB to 84 dB.
4.3 Controlling Alarm

4.3.1 Setting Parameter Alarm
Parameter alarm settings including alarm switch, alarm record, alarm level and alarm limit are
available on the respective alarm setup menu for each parameter. To access the menu for
parameter alarm settings, use the shortcut key or select Menu> Alarm Setup, and then
click Alarm Options to open the menu shown below for alarm settings of each parameter. Also,
you can access this menu via the respective parameter setup menu.
- 29 -
Upper arrow or
lower arrow to
increase or
decrease the High
alarm limit Alarm Limit
Setting value of
high alarm limit
Setting value of Low

low alarm limit Alarm Limit
WARNING
1 When the alarm is set to OFF, the monitor won’t give an alarm prompt even if an
alarm occurs. In order to avoid endangering the patient’s life, the user should use this
function cautiously.
2 Prior to monitoring, make sure that the alarm limit settings are appropriate for your
patient.
3 Setting alarm limits to extreme values may cause the alarm system to become
ineffective.
4.3.2 Temporary Alarm Mute

The monitor will give an audible alarm when there is an alarm during the audio alarm pause and
the alarm indicator and screen flash indicating there is an alarm. The top of monitor displays the
following:
1. Alarm pause symbol

2. The remaining pause time is displayed in text and the word background is red.
The user can set the audio alarm pause to 60 s, 120 s, or 180 s based on the requirement.
4.3.3 Alarm Mute

To mute the alarm, please select Menu > Maintenance > User Maintain > Alarm Setup, and
set Mute to On, then press the key on the front panel for more than three seconds or
press the Silence shortcut key on the screen directly.
And alarm reminder tone DO is heard every three minutes.
- 30 -
4.3.4 Controlling Alarm Volume

The monitor provides five levels of alarm volume: 1, 2, 3, 4 and 5. For adjusting the alarm
volume, please refer to Section Adjusting Alarm Volume.
4.4 Latching Alarms

To set the alarm latch function, please select Menu > Maintenance > User Maintain > Alarm
Setup and set Alarm Latch from the pull-down list. If it is set to On, when an alarm occurs, the
monitor will display the alarm message of the parameter in the alarm status area. If the parameter
resumes to normal, the alarm information of this parameter still displays in the alarm display area
and the alarm time is also displayed. If many parameters appear to be latching alarms, the alarm
messages are displayed in the physiological alarm message area in turn.
To deselect the alarm latch, please set Alarm Latch to Off. When Alarm Latch is set to Off, the
latch function is invalid.
4.5 Disabling Sensor Off Alarms

To set sensor off alarm, please select Menu > Maintenance > User Maintain and enter the
required password ABC. Then select Alarm Setup and set Sensor Off Alm from the pull-down
list. If it is set to On, and a sensor off alarm occurs, the user can press the Mute key on the front
panel to disable the alarm signal. Then the alarm indicator stops flashing, and the monitor is in
temporary mute alarm status. If the user presses the Mute key again or the temporary mute time
ends, no audible alarm for sensor-off status will be resumed. Instead, sensor-off status will be
announced with a prompt message.
4.6 Testing Alarms

When you switch the monitor on, a self test is started. You must check that the alarm indicator
lights and that you hear a single tone. This indicates that the visible and audible alarm indicators
are functioning correctly. For further testing of individual measurement alarms, perform the
measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm
behavior is observed.
- 31 -
Patient Monitor User Manual Alarm Information
Chapter 5 Alarm Information

5.1 Physiological Alarm Information
Message Cause Alarm level
HR High HR measuring value is above the upper alarm limit. User-selectable
HR Low HR measuring value is below the lower alarm limit. User-selectable
ST measuring value is above the upper alarm limit. (X
ST-X High stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, User-selectable
V4, V5 or V6)
ST measuring value is below the lower alarm limit.(X
ST-X Low stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, User-selectable
V4, V5 or V6)
PVCs High PVCs measuring value is above the upper alarm limit. User-selectable
ASYSTOLE No QRS is detected for 4 consecutive seconds High
Ventricular tachycardia: The RR interval of 4-second
VFIB/VTAC fibrillation wave or 5 consecutive ventricular beats is High
less than 600 ms.
VT>2 3< the number of cluster PVCs < 5 User-selectable
COUPLET 2 consecutive PVCs User-selectable
BIGEMINY Vent Bigeminy User-selectable
TRIGEMINY Vent Trigeminy User-selectable
A type of single PVC under the condition that
HR<100ˈR-R interval is less than 1/3 the average
R ON T interval, followed by a compensating pause of 1.25X User-selectable
the average R-R interval (the next R wave advances
onto the previous T wave).
PVC Single PVC detected in normal heartbeats. User-selectable
Adult: 5 consecutive QRS complex, RR interval <
0.5s (HR range: 120~300bpm).
TACHY User-selectable
Pediatric/neonatal: 5 consecutive QRS complex, RR
interval < 0.375s (HR range: 160~350bpm).
Adult: 5 consecutive QRS complex, RR interval
1.5s (HR range: 15~40bpm).
BRADY User-selectable
Pediatric/neonatal: 5 consecutive QRS complex, RR
interval 1s (HR range: 15~60bpm).
- 32 -

When HR is less than 120 beats/min., no heart beat is
tested during the period 1.75 times of the average RR
MISSED BEATS interval; or User-selectable
When HR is 120 beats/min, no beat is tested within 1
second.
IRREGULAR RHYTHM: The patient has irregular
IRR User-selectable
heart rate.
PACE NOT CAPTURE: After the pacemaker is
PNC paced, QRS complex can not be detected during User-selectable
300ms.
PACER NOT PACED: After the QRS complex, no
PNP User-selectable
pace is detected during 1.75 times of RR interval.
VENTRICULAR BRADYCARDIA: The interval of 5
VBRADY User-selectable
consecutive ventricular wave is more than 1000 ms.
VENTRICULAR RHYTHM: The interval of 5
VENT consecutive ventricular wave ranges from 600 ms to User-selectable
1000 ms.
RESP can not be measured within the set apnea alarm
RESP APNEA High
delay time.
RR High RR measuring value is above upper alarm limit. User-selectable
RR Low RR measuring value is below lower alarm limit. User-selectable
SpO2 High SpO2 measuring value is above upper alarm limit. User-selectable
SpO2 Low SpO2 measuring value is below lower alarm limit. User-selectable
The signal of the measurement site is too weak, so the
SpO2 No Pulse High
monitor can’t detect the pulse signal.
PR High PR measuring value is above upper alarm limit. User-selectable
PR Low PR measuring value is below lower alarm limit. User-selectable
Measuring value of T1 channel is above upper alarm
T1 High User-selectable
limit.
Measuring value of T1 channel is below lower alarm
T1 Low User-selectable
limit.
Measuring value of T2 channel is above upper alarm
T2 High User-selectable
limit.
Measuring value of T2 channel is below lower alarm
T2 Low User-selectable
limit.
Measuring value of TD channel is above upper alarm
TD High User-selectable
limit.
- 33 -

SYS High SYS measuring value is above upper alarm limit. User-selectable
SYS Low SYS measuring value is below lower alarm limit. User-selectable
DIA High DIA measuring value is above upper alarm limit. User-selectable
DIA Low DIA measuring value is below lower alarm limit. User-selectable
MAP High MAP measuring value is above upper alarm limit. User-selectable
MAP Low MAP measuring value is below lower alarm limit. User-selectable
Art SYS High Art SYS measuring value is above upper alarm limit. User-selectable
Art SYS Low Art SYS measuring value is below lower alarm limit. User-selectable
Art DIA High Art DIA measuring value is above upper alarm limit. User-selectable
Art DIA Low Art DIA measuring value is below lower alarm limit. User-selectable
Art MAP High Art MAP measuring value is above upper alarm limit. User-selectable
Art MAP Low Art MAP measuring value is below lower alarm limit. User-selectable
PA SYS High PA SYS measuring value is above upper alarm limit. User-selectable
PA SYS Low PA SYS measuring value is below lower alarm limit. User-selectable
PA DIA High PA DIA measuring value is above upper alarm limit. User-selectable
PA DIA Low PA DIA measuring value is below lower alarm limit. User-selectable
PA MAP High PA MAP measuring value is above upper alarm limit. User-selectable
PA MAP Low PA MAP measuring value is below lower alarm limit. User-selectable
CVP MAP High CVP MAP measuring value is above upper alarm limit. User-selectable
CVP MAP Low CVP MAP measuring value is below lower alarm limit. User-selectable
ICP MAP High ICP MAP measuring value is above upper alarm limit. User-selectable
ICP MAP Low ICP MAP measuring value is below lower alarm limit. User-selectable
LAP MAP High LAP MAP measuring value is above upper alarm limit. User-selectable
LAP MAP Low LAP MAP measuring value is below lower alarm limit. User-selectable
RAP MAP High RAP MAP measuring value is above upper alarm limit. User-selectable
RAP MAP Low RAP MAP measuring value is below lower alarm limit. User-selectable
P1 SYS High P1 SYS measuring value is above upper alarm limit. User-selectable
P1 SYS Low P1 SYS measuring value is below lower alarm limit. User-selectable
P1 DIA High P1 DIA measuring value is above upper alarm limit. User-selectable
P1 DIA Low P1 DIA measuring value is below lower alarm limit. User-selectable
P1 MAP High P1 MAP measuring value is above upper alarm limit. User-selectable
P1 MAP Low P1 MAP measuring value is below lower alarm limit. User-selectable
- 34 -

P2 SYS High P2 SYS measuring value is above upper alarm limit. User-selectable
P2 SYS Low P2 SYS measuring value is below lower alarm limit. User-selectable
P2 DIA High P2 DIA measuring value is above upper alarm limit. User-selectable
P2 DIA Low P2 DIA measuring value is below lower alarm limit. User-selectable
P2 MAP High P2 MAP measuring value is above upper alarm limit. User-selectable
P2 MAP Low P2 MAP measuring value is below lower alarm limit. User-selectable
EtCO2 High EtCO2 measuring value is above upper alarm limit. User-selectable
EtCO2 Low EtCO2 measuring value is below lower alarm limit. User-selectable
FiCO2 High FiCO2 measuring value is above alarm limits. User-selectable
In the set apnea alarm delay time interval, no RESP
CO2 APNEA High
can be detected using CO2 module.
AwRR High AwRR measuring value is above upper alarm limit. User-selectable
AwRR Low AwRR measuring value is below lower alarm limit. User-selectable
EtCO2 (AG) measuring value is above upper alarm
EtCO2 (AG) High User-selectable
limit.
EtCO2 (AG) measuring value is below lower alarm
EtCO2 (AG) Low User-selectable
limit.
FiCO2 (AG) High FiCO2 (AG) measuring value is above alarm limits. User-selectable
AwRR (AG) measuring value is above upper alarm
AwRR (AG) High User-selectable
limit.
AwRR (AG) measuring value is below lower alarm
AwRR (AG) Low User-selectable
limit.
EtO2 High EtO2 measuring value is above upper alarm limit. User-selectable
EtO2 Low EtO2 measuring value is below lower alarm limit. User-selectable
FiO2 High FiO2 measuring value is above upper alarm limit. User-selectable
FiO2 Low FiO2 measuring value is below lower alarm limit. User-selectable
EtN2O High EtN2O measuring value is above upper alarm limit. User-selectable
EtN2O Low EtN2O measuring value is below lower alarm limit. User-selectable
FiN2O High FiN2O measuring value is above upper alarm limit. User-selectable
FiN2O Low FiN2O measuring value is below lower alarm limit. User-selectable
EtHAL High EtHAL measuring value is above upper alarm limit. User-selectable
EtHAL Low EtHAL measuring value is below lower alarm limit. User-selectable
FiHAL High FiHAL measuring value is above upper alarm limit. User-selectable
FiHAL Low FiHAL measuring value is below lower alarm limit. User-selectable
- 35 -

EtENF High EtENF measuring value is above upper alarm limit. User-selectable
EtENF Low EtENF measuring value is below lower alarm limit. User-selectable
FiENF High FiENF measuring value is above upper alarm limit. User-selectable
FiENF Low FiENF measuring value is below lower alarm limit. User-selectable
EtISO High EtISO measuring value is above upper alarm limit. User-selectable
EtISO Low EtISO measuring value is below lower alarm limit. User-selectable
FiISO High FiISO measuring value is above upper alarm limit. User-selectable
FiISO Low FiISO measuring value is below lower alarm limit. User-selectable
EtSEV High EtSEV measuring value is above upper alarm limit. User-selectable
EtSEV Low EtSEV measuring value is below lower alarm limit. User-selectable
FiSEV High FiSEV measuring value is above upper alarm limit. User-selectable
FiSEV Low FiSEV measuring value is below lower alarm limit. User-selectable
EtDES High EtDES measuring value is above upper alarm limit. User-selectable
EtDES Low EtDES measuring value is below lower alarm limit. User-selectable
FiDES High FiDES measuring value is above upper alarm limit. User-selectable
FiDES Low FiDES measuring value is below lower alarm limit. User-selectable
AG FiO2 Low FiO2 measure value is extremely low. High
In the set apnea alarm delay time interval, no RESP
AG APNEA High
can be detected using AG module.
TB High TB measuring value is above upper alarm. User-selectable
TB Low TB measuring value is below lower alarm. User-selectable
- 36 -
5.2 Technical Alarm Information

NOTE:
The ECG alarm information listed in the below table describes the lead names in
America. For the corresponding lead names in Europe, please refer to Section Installing
Electrodes.
Message Cause Alarm Level Action Taken

1) The drive lead or more
than one ECG limb
ECG Lead Off electrode falls off the skin; Low
2) ECG cables fall off the
monitor.
ECG electrode V falls off

ECG V Lead Off the skin or the ECG cable Low
V falls off the monitor. Make sure that all
electrodes, leads and
patient cables are
properly connected.
ECG electrode LL falls off

ECG LL Lead Off the skin or the ECG cable Low
LL falls off the monitor.
ECG electrode LA falls off
ECG LA Lead Off the skin or the ECG cable Low
LA falls off the monitor.
ECG electrode RA falls off
ECG RA Lead Off the skin or the ECG cable Low
RA falls off the monitor.
Check lead
ECG measuring value is
ECG Signal Exceed High connection and
beyond measuring range.
patient condition
The amplitude of ECG Please modify the

ECG Signal Overflow Low
signal is too wide. ECG gain.
- 37 -

Stop measuring
function of ECG
ECG module failure or module, and notify
ECG Comm Fail High
communication failure biomedical engineer
or manufacturer’s
service staff.
Check lead
ECG measuring signal is
ECG Noise Low connection and
greatly interrupted.
patient condition
ECG electrode V1 falls off

ECG V1 Lead Off the skin or the ECG cable Low
V1 falls off.

V2 falls off.

Make sure that all
V3 falls off.
electrodes, leads and
patient cables are
properly connected.
V4 falls off.

V5 falls off.

V6 falls off.
Stop measuring
function of RESP
RESP module failure or module, and notify
RESP Comm Fail High
or the manufacturer’s
service staff.
- 38 -

Check whether
interference to the
respiratory signal
RR measuring value is out exists. And check
of the measure range (less whether the patient is
RR Exceed Medium
than 6rpm or greater than breathing normally;
150rpm). breathing too rapidly
or too slowly may
endanger patient’s
life.
Check whether the
patient is breathing
normally. Take
measures to help the
patient breathe
normally when
No RESP waveform can
necessary. If the
be detected due to apnea or
RESP Cardiac Artifact High patient is breathing
shallow breathing of the
normally, try to
patient.
adjust the electrode
position on the
patient in order to
reduce the
interference of
cardiogenic artifact.
Check whether the
RESP leads are well
RR cannot be measured
RESP Noise Low connected. Keep the
due to patient movement.
patient calm for
better monitoring.
Make sure the sensor
SpO2 sensor may be
is well connected to
SpO2 Sensor Off disconnected from the Low
the patient’s finger
patient or the monitor.
or other parts.
Malfunction in the SpO2 Replace the SpO2

SpO2 Sensor Err sensor or in the extension Low sensor or the
cable. extension cable.
SpO2 sensor was not Make sure the

connected well or monitor and sensor
SpO2 No Sensor Low
connected to the monitor, is well connected,
or the connection is loose. reconnect the sensor.
- 39 -

Stop using
measuring function
of SpO2 module, and
SpO2 module failure or
SpO2 Comm Fail High notify biomedical
communication failure
engineer or
manufacturer’s
service staff.
Reconnect the SpO2
sensor and change
The pulse signal is too the measurement
weak or the perfusion of site. If problem
SpO2 Low Perfusion Low
the measurement site is exists, please notify
too low biomedical engineer
or manufacturer’s
service staff.
Check the condition
There is interference with of patient and avoid
SpO2 measurement signals patient movement;
SpO2 Noisy Signal Low
and the waveform is make sure the cable
abnormal. is well connected.
Reduce interference
of the ambient light
SpO2 Light Ambient light around the and avoid sensor’s
Low
Interference sensor is too strong. exposure to strong
light.
Stop using
measuring function
of NIBP module, and
NIBP module failure or
NIBP Comm Fail High notify biomedical
communication failure
engineer or
manufacturer’s
service staff.
- 40 -

Properly wrap the
cuff and connect the
tube. Measure again;
if failure persists,
NIBP pump, valve, cuff or stop measuring
NIBP Leak Low
tube has a leakage. function of NIBP
module and notify
biomedical engineer
or manufacturer’s
service staff.
Measure again, if
failure persists, stop
measuring function
Pressure has exceeded the
NIBP Excessive of NIBP module and
specified upper safety Low
Pressure notify biomedical
limit.
engineer or
manufacturer’s
service staff.
Measure again, if
failure persists, stop
measuring function
NIBP Init Pressure The initial pressure is too of NIBP module and
Low
High high during measuring notify biomedical
engineer or
manufacturer’s
service staff.
If failure persists,
stop using measuring
function of NIBP
Sensor or other hardware
NIBP Self Test Error High module and notify
errors.
biomedical engineer
or manufacturer’s
service staff.
The cuff type used isn’t Confirm the patient

NIBP Cuff Type
consistent with the patient Low type and change the
Error
type. cuff.
- 41 -

Check whether the
airway is occluded
or pressure sensor
Malfunction in pressure
Air Pressure Error Low works properly. If
sensor or valve
the problem still
exists, contact your
service personnel.
Contact your service

NIBP System Failure Malfunction in hardware High
personnel.
Check the
connection of the
cuff and try again. If
Cuff is too loose or patient
NIBP Weak Signal Low failure persists, use
pulse is too weak.
other methods to
measure blood
pressure.
Maybe the patient blood Use other methods
NIBP Range Exceeded pressure value is beyond Low to measure blood
the measurement range. pressure.
Cuff is not properly Properly wrap the
NIBP Loose Cuff wrapped or no cuff is Low cuff.
connected.
Make sure that the
Signal noise is too large or patient under
NIBP Interference Low
pulse rate is not regular. monitoring is
motionless.
Notify biomedical
HW Excessive Hardware excessive engineer or
High
Pressure pressure protection manufacturer’s
service staff.
Measuring time has Measure again or
NIBP Time Out exceeded the specified Low use other measuring
time. methods.
Temperature cable of
Make sure that the
TEMP channel 1 may be
TEMP T1 Sensor Off Low cable is properly
disconnected from the
connected
monitor.
- 42 -

Temperature cable of
Make sure that the
TEMP channel 2 may be
TEMP T2 Sensor Off Low cable is properly
disconnected from the
connected.
monitor.
Check sensor
TEMP1 measuring value is
Excessive T1 High connection and
patient condition
Check sensor
TEMP2 measuring value is
Excessive T2 High connection and
patient condition
Stop measuring
function of TEMP
TEMP module failure or module, and notify
TEMP Comm Fail High
communication failure. biomedical engineer
or Manufacturer’s
service staff.
YY Sensor Off (YY Check the sensor

stands for the IBP IBP sensor falls off. Low connection and
label name) reconnect the sensor.
Stop measuring
function of IBP
YY Comm Fail (YY
IBP module failure or module, and notify
stands for the label High
name)
or Manufacturer’s
service staff.
Stop measuring of
C.O. module, or
C.O. module failure or notify biomedical
C.O. Comm Fail High
communication failure engineer or
Manufacturer’s
service staff.
C.O. TI sensor not Insert injective
C.O. TI No Sensor Low
connected temperature sensor.
C.O. TB sensor not
C.O. TB No Sensor Low Insert TB sensor.
connected
TB measuring value is Please check TB
TEMP Out Of Range High
above measuring range. sensor.
- 43 -

C.O. measuring needs Please input patient’s
C.O. Lack Param High
parameters height and weight.
The AA concentration
Reduce AA
AA Out Of Range exceeds the accuracy range High
concentration.
of AG module.
Stop measuring of
AG module, and
The oxygen sensor of the
notify biomedical
O2 Sensor Error sidestream AG module has Medium
engineer or
a failure.
Manufacturer’s
service staff.
Stop measuring
function of AG
AG module failure or module, and notify
AG Comm Fail High
communication failure. biomedical engineer
or Manufacturer’s
service staff.
Please perform
AG Zero Required AG module requires zero. Low
zeroing.
Please wait the self
AG Self-Testing AG module is self testing. Low
testing finishing.
AG Replace O2 O2 sensor needs to be Please replace the O2
High
Sensor replaced. sensor.
Please wait check
AG Check Adapter AG module checks adapter. Low
finishing.
O2 Cali Required O2 needs to be calibrated. Low Please calibrate O2.
AG module software Please replace

AG Software Error High
abnormal software revision.
Please check whether
AG module has hardware
AG Hardware Error High the hardware work
failure.
properly.
AG module motor
AG Motor Error High the motor works
abnormal
properly.
Please calibrate the
AG Uncalibrated AG module uncalibrated Low
AG module.
AG module needs to Please replace the
AG Replace Adapter High
change adapter. adapter.
- 44 -

Please make O2
O2 Out Of Range O2 is out of range. High range resume
normal.
Please make the
AG TEMP Out Of AG module temperature
High temperature resume
Range out of range
normal.
Please make the baro
AG Baro Press Out AG module baro pressure
High pressure value
Of Range out of pressure
resume normal.
AG module can’t identify Reduce gas agent
AG AA Id Unreliable Medium
the AG agent. type.
AG Span Calib In Please wait
AG module is calibrating. Low
Progress calibration finishing.
AG module calibration
AG Calibration Fail Medium the module works
failure
properly.
AG module can’t be
Unable To Calibrate Medium the module works
calibrated.
properly.
AG Zero In Progress AG module is zeroing. Low Please wait zeroing.
The sampling line is Replace the

AG Occlusion Medium
clogged. sampling line.
AG module works
AG Init Fail AG module has a failure. High
improperly.
AG module works
AG Data Limit Error AG module has a failure. High
improperly.
AG module works
AG Usa Error AG module has a failure. High
improperly.
AG module fails to AG module works
AG Cal Fail High
calibrate. improperly.
AG module works
AG Zref Fail AG module fails to zero. High
improperly.
AG Change Oxygen Replace oxygen sensor of Please wait changing
Low
Sensor AG module. finishing.
AG No Oxygen The oxygen sensor falls off Connect the sensor
High
Sensor from the AG module. again.
- 45 -

AG module detects mixture Close the subsidiary
AG Mixed Agents Medium
gas agent. gas agent.
Water trap of SideStream is Make sure the gas

CO2 Occlude High
occluded. exhaust works well
The CO2 concentration

CO΍ Out Of Range Reduce CO2
exceeds the accuracy range High
concentration.
of CO2 module.
Stop measuring
function of CO2
CO2 Sensor Faulty CO2 module failure High
module, notify
biomedical engineer.
Stop measuring
CO2 measure value exceeds
CO2 Sensor Over function of CO2
the measure range of the High
Temp module, notify
monitor.
biomedical engineer.
CO2 module failure or Check if the water

CO2 Comm. Failed High
communication failure tray has been fixed.
Disconnect the
sampling cannula or
adapter from the
airway; initiate the
CO2 Zero Required Zero calibration failure Low zeroing before
making sure that no
expired air is inside
the sampling cannula
and adapter.
- 46 -

1) For the
Respironics CO2
1) For the Respironics CO2 module: Check
module: The cannula is off whether the adapter
or disconnected. is properly connected
CO2 Check Adapter 2) For the EDAN CO2 Low or replace the
module: The water trap is adapter.
disconnected or not 2) For the EDAN
properly connected. CO2 module:
Properly connect the
water trap.
The AA concentration
Reduce AA
AA Out Range exceeds the accuracy range High
concentration.
of AG module.
Stop measuring of
AG module, and
The oxygen sensor of the
notify biomedical
O2 Sensor Error sidestream AG module has Medium
engineer or
a failure.
Manufacturer’s
service staff.
Stop measuring
function of TEMP
QuickTemp Comm TEMP module failure or module, and notify
High
Fail communication failure. biomedical engineer
or manufacturer’s
service staff.
Put the sensor into
The TEMP value is beyond
the sensor bracket,
Temp exceed limit the range of +25qC ~ Med
take it out and
+45qC.
measure again.
TEMP sensor is not Connect the sensor

No Temp Sensor connected to the TEMP Low and the monitor well,
module. and measure again.
Put the sensor into

the sensor bracket,
Ambient temp too The Sensor temperature is measure again after
Low
high higher than +40qC. the ambient
temperature reaches
normal value.
- 47 -

Put the sensor into
the sensor bracket,
The Sensor temperature is measure again after
Ambient temp too low Low
lower than +10qC. the ambient
temperature reaches
normal value.
Put the sensor into
the sensor bracket,
take it out and
measure again. If the
Offline: NTC resistance >R problem persists,
Probe data error 0 qC; Short: NTC Med stop using measuring
resistance <R+100 qC. function of TEMP
module, and notify
biomedical engineer
or manufacturer’s
service staff.
Put the sensor into
the sensor bracket,
take it out and
measure again. If the
problem persists,
Probe heater error Single failure Med stop using measuring
function of TEMP
module, or notify
biomedical engineer
or manufacturer’s
service staff.
Put the sensor into
the sensor bracket,
The original temperature of
measure again after
Probe temp too high sensor >+33 qC & +40 Low
the sensor
qC.
temperature reaches
normal value.
After the sensor
Reconnect the sensor
temperature reaches Predict
and make sure that
Temp Sensor Off value, it descends to the Med
the cable is properly
value lower than Predict
connected.
value.
- 48 -
Please change the

Battery Low Battery Low High
battery or charging.
Recorder Out Of
Paper Please install the
Recorder Out Of Paper Low
paper
The user presses the Notify the

Recorder setup RECORD button when the manufacturer’s
Low
needed monitor is not installed service staff to install
with a recorder. and set the recorder.
Delete some data in
Removable device is Less than 10M space is left the removable device
Low
full in the removable device. or use another
removable device.
Repair the removable

Removable dev The removable device is
Low device or replace it
read-only read-only.
with a new one.
5.3 Prompts
Message Cause
The QRS template building required for Arr. Analysis is in

ECG Arr Learning
process.
SpO2 module is analyzing the patient signal and searching

SpO2 Search Pulse for the pulse to compute the saturation, when sensor is
connected with patient.
Manual Measuring In manual measuring mode
Continual Measuring In continuous measuring mode
Auto Measuring In automatic measuring mode
Measure Abort Measurement over
Calibrating During calibrating
Calibrate Abort Calibration over
Leak Testing During pneumatic test
Leak Test Ok NIBP module has passed leak test.
Leak Test Abort Pneumatic test over
- 49 -
Message Cause
Resetting NIBP module in resetting
Please Start NIBP module is in idle status.
Done NIBP measurement successfully done
Continual Measuring NIBP module performs continual measuring
Stat Measuring NIBP module performs STAT function.
NIBP module is in normal mode, the user can’t start leak
test and pressure calibration. Please enter User Maintain >
Please Switch To Maintain Mode
NIBP Maintain and switch to Maintain Mode to perform
leak test or pressure calibration.
NIBP module is in maintaining mode, the user can’t start
blood pressure measurement. Please enter User Maintain
Please Switch To Normal Mode
> NIBP Maintain and switch to Normal Mode to perform
blood pressure measurement.
Quick TEMP Is Warming Up Quick TEMP Is Warming Up.
Place Probe On Measure Place Probe isn’t placed on the measurement site.
Turn from measuring mode to standby mode, making the
CO2 Standby
module in energy-saving status.
CO2 Sensor Warm Up The CO2 module is in warm-up state.
Zeroing... The CO2 module is performing the zero calibration.
Excessive C.O. Temp TB measuring value is beyond measuring range.
Excessive Temp, C.O.
C.O. measuring needs parameters.
Measurement Fail.
C.O. measure need param HEMOD calculation needs parameters.
Insufficient factors for Hemod
HEMO Dynamics calculation needs parameters.
Dynamics
No Sensor, C.O. measurement
No Sensor,C.O. measurement fail
fail
Measuring... The C.O. module is performing measuring.
Ready for new measurement C.O. module is ready for new measurement.
Invalid C.O. result C.O. measurement result is invalid.
C.O. Measurement Complete C.O. Measurement is completed.
C.O. Measurement Abort C.O. Measurement is aborted.
Warm-up over The monitor displays this message after taking the sensor
out of the bracket and warm-up is over.
- 50 -
Message Cause
Measure over After the Predict measuring is over, the data and message
display on the interface.
Measure time out No measuring result after the module entering Predict
state for 30s.
AG Standby AG module is operating in the standby status.
5.4 Adjustable Range of Alarm Limits

ECG alarm limits are listed as follows: unit (bpm)
Patient Type ALM HI ALM LO
HR ADU 300 15
PED 350 15
NEO 350 15
ST analysis alarm limits are listed as follows: unit (mV)

ALM HI ALM LO
ST 2.0 -2.0
PVCs alarm upper limits are listed as follows:

ALM HI ALM LO
PVCs 10
- 51 -
RESP alarm limits are listed as follows: unit (rpm)

ADU 120 6
PED 150 6
NEO 150 6
SpO2 alarm limits are listed as follows (unit %):

ALM HI ALM LO
SpO2 100 0
PR alarm limits is listed as follows: unit (bpm)

ALM HI ALM LO
PR 300 30
NIBP alarm limits are listed as follows (EDAN module): unit (mmHg)
ADU SYS 270 40
DIA 215 10
MAP 235 20
PED SYS 200 40
DIA 150 10
MAP 165 20
NEO SYS 135 40
DIA 100 10
MAP 110 20
NIBP alarm limits are listed as follows (Omron module): unit (mmHg)
SYS 250 60
ADU(PED) DIA 200 40
MAP 235 45
SYS 120 40
NEO DIA 90 20
MAP 100 30
- 52 -
TEMP alarm limits are listed as follows:

ALM HI ALM LO
T1 50qC (122 º F) 0qC (32 º F)
T2 50qC (122 º F) 0qC (32 º F)
TD 50qC (90 º F) 0qC (0 º F)
IBP alarm limits are listed as follows: unit (mmHg)

ALM HI ALM LO
Art 300 0
RAP 40 -10
LAP 40 -10
CVP 40 -10
PA 120 -6
ICP 40 -10
P1 300 -50
P2 300 -50
CO2 alarm limits are listed as follows:

ALM HI ALM LO
EtCO2 150 mmHg 0
FiCO2 50 mmHg 3
AwRR 150 rpm 2 rpm
C.O. alarm limits are listed as follows:

ALM HI ALM LO
TB 43qC (109.4̧) 23qC(73.4̧)
Quick Temp alarm limits are listed as follows:

ADU 42qC (107.6̧) 35.5qC (95.9̧)
PED 42qC (107.6̧) 35.5qC (95.9̧)
- 53 -
AG alarm limits are listed as follows:

ADU FiCO2 25.0% 0.0%
EtCO2 25.0% 0.0%
FiO2 88.0% 18.0%
EtO2 90.0% 18.0%
FiN2O 100.0% 0.0%
EtN2O 100.0% 0.0%
EtDes 18.0% 0%
FiDes 18.0% 0%
EtIso 5.0% 0%
FiIso 5.0% 0%
EtHal 5.0% 0%
FiHal 5.0% 0%
EtSev 8.0% 0%
FiSev 8.0% 0%
EtEnf 5.0% 0%
FiEnf 5.0% 0%
awRR 150 rpm 0 rpm
Apnea Time 40s 20s
PED FiCO2 25.0% 0.0%
EtCO2 25.0% 0.0%
FiO2 88.0% 18.0%
EtO2 90.0% 18.0%
FiN2O 100.0% 0.0%
EtN2O 100.0% 0.0%
EtDes 18.0% 0%
FiDes 18.0% 0%
EtIso 5.0% 0%
FiIso 5.0% 0%
EtHal 5.0% 0%
FiHal 5.0% 0%
- 54 -
EtSev 8.0% 0%
FiSev 8.0% 0%
EtEnf 5.0% 0%
FiEnf 5.0% 0%
awRR 150 rpm 0 rpm
Apnea Time 40s 20s
NEO FiCO2 25.0% 0.0%
EtCO2 25.0% 0.0%
FiO2 88.0% 18.0%
EtO2 90.0% 18.0%
FiN2O 100.0% 0.0%
EtN2O 100.0% 0.0%
EtDes 18.0% 0%
FiDes 18.0% 0%
EtIso 5.0% 0%
FiIso 5.0% 0%
EtHal 5.0% 0%
FiHal 5.0% 0%
EtSev 8.0% 0%
FiSev 8.0% 0%
EtEnf 5.0% 0%
FiEnf 5.0% 0%
awRR 150 rpm 0 rpm
Apnea Time 40 s 20 s
- 55 -
Patient Monitor User Manual Managing Patients
Chapter 6 Managing Patients

6.1 Admitting a Patient
The monitor displays physiological data and stores it in the trends as soon as a patient is
connected. This allows you monitor a patient who is not yet admitted. It is however important to
admit patients properly so that you can identify your patient on recordings, reports, and
networked devices.
During admission you enter data that the monitor needs for safe and accurate operation. For
example, the patient category setting determines the algorithm the monitor uses to process and
calculate some measurements, the safety limits that are applied for some measurements, and the
alarm limit ranges.
To admit a patient, please:
1. Select the Admission key on the screen or.
2. Select Menu > Patient Setup > New Patient, then a message is displayed to ask the user to
confirm to update patient.
3. Click on No to cancel this operation; click on Yes, the Patient Info window is displayed.
4. Enter the patient information:
z Serial No: Enter the patient’s medical record number (MRN), for example 12345678.
z Last name: Enter the patient’s last name (family name), for example Smith.
z First name: Enter the patient’s first name, for example Joseph.
z Gender: Male, Female and N/A.
z Type: Choose the patient type, either Adult, Pediat, or Neonat.
z BloodType: N/A, A, B, AB and O.
z Pace: Choose On or Off (You must select On if your patient has a pacemaker).
z Date of Birth: Enter the patient’s date of birth.
z Date of Admission: Enter the patient’s date of admission.
z Height: Enter the patient’s height.
z Weight: Enter the patient’s weight.
z Doctor: Enter any extra information about the patient or treatment.
5. Select Exit.
6.1.1 Patient Category and Paced Status

The patient category setting determines the algorithm the monitor uses to process and calculate
some measurements, the safety limits that are applied for some measurements, and the alarm limit
ranges.
The paced setting determines whether the monitor shows pacemaker pulses or not. When Pace is
set to Off, pace pulses are filtered and therefore do not show in the ECG wave.
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WARNING
1 Changing the patient category may change the arrhythmia and NIBP alarm limits.
Always check alarm limits to make sure that they are appropriate for your patient.
2 For paced patients, you must set Paced to On. If it is incorrectly set to Off, the monitor
could mistake a pace pulse for a QRS and fail to give an alarm during asystole.
6.2 Quick Admit

If you do not have the time or information to fully admit a patient. Complete the rest of the
patient information later. To quickly admit a patient, please:
1. Select Menu > Patient Setup > Quick Admit, then a message is displayed to ask the user to
confirm to update patient.
2. Click on No to cancel this operation; click on Yes to continue and the Patient Info window
is displayed, choose Type and Pace and set them to the correct mode.
3. Select Exit.
6.3 Editing Patient Information

To edit the patient information after a patient has been admitted, select Menu > Patient Setup >
Patient Info., and make the required changes on the popup interface.
6.4 Updating a Patient

You should always perform an update before starting monitoring for a new patient. When you
select Menu > Patient Setup > Quick Admit, or Menu > Patient Setup > New Patient, a
message of Press ‘Yes’ to create new patient profile by clearing all current patient data... is
displayed.
z If the user selects Yes, the monitor will update the patient information.
z If the user selects No, the monitor won’t update the patient information and returns to
patient setup interface.
NOTE:
Discharging patient will clear the history data in the monitor associated with the patient.
6.5 Central Monitoring System

The monitor can be connected to the central monitoring system. Through the network:
1. The monitor sends patient information, real-time monitoring or measurement data to the
central monitoring system.
2. The real-time monitoring information is displayed on the central monitoring system as the
- 57 -
same to the monitor, and the central monitoring system can perform some bilateral control.
For example: changing patient information, alarm limit and so forth.
For detailed information, please refer to MFM-CMS Central Monitoring System User Manual and
CNS Central Monitoring System User Manual.
And the monitor supports HL 7 protocol.
NOTE:
1 Make sure the network connection between the monitor and the central monitoring
system is in good condition when the time synchronization function on the monitor is
active.
2 The time synchronization function might not be available to all software versions of
MFM-CMS. Consult our technical service department or your local distributor for
more information.
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Patient Monitor User Manual User Interface
Chapter 7 User Interface

7.1 Setting Interface Style
The user can set the interface based on the requirement, and the set options include the following:
z Sweep of the waveform.
z Parameters needing to be monitored.
Change to some settings may have the risk, so only the authorized person can change them. After
changing the settings, please notify the operator.
7.2 Selecting Display Parameters

The user can select the display parameters based on the monitoring and measurement
requirements. To select the parameter, please:
1. Select Menu > System Setup > Module Switch.
2. Select the required parameters from the popup interface.
3. Press Exit to exit the menu and the screen will adjust the parameters automatically.
7.3 Changing Waveform Position

The user can exchange the waveform positions of parameter A and parameter B, please refer to
the following steps to do so:
1. Select waveform A and open the setup menu of waveform A.
2. Select Change from the popup menu and select the desired label name of waveform B from
the pull-down list.
7.4 Changing Interface Layout

To change the interface layout, please refer to the following steps:
1. Select Menu > Display Setting.
2. Select one interface from the popup menu.
3. The user can implement one kind of function screen based on the requirements. If the user
selects the Large Font option, there is no function screen to be selected.
7.5 Viewing Trend Screen

To view the short trend screen, the user can press the Trend Screen key on the screen directly or
select Menu > Display Setting > View Selection > TrendScreen.
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7.6 Viewing Oxygen Screen

To view the oxygen screen, the user can press the oxyCRG key on the screen or select Menu >
Display Setting > View Selection > oxyCRG. This interface is always used in NICU because
the SpO2, HR and Resp of the neonate are different from those of adults.
7.7 Viewing Large Font Screen

To open the large font screen, please refer to the following steps:
1. Select the Large Font key on the screen directly or.
2. Select Menu > Display Setting > View Selection > Large Font to open this interface.
To view the large font interface of specific parameter, please select the parameter pull-down
dialog on the interface (the red circle shown in the following figure).
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7.8 Viewing the Bed View Window

The Bed View window allows you to view one waveform, numeric information of all parameters
and alarm information from another bed on the same network. The monitor enables a maximum
of eight beds to be viewed.
NOTE:
1 The IP addresses of the monitors configured with bed view function should share the
same network segment. The IP addresses of the monitors on the same LAN should
be unique from each other; you cannot use the bed view function in the monitors in
which an IP address conflict exits.
2 To use the bed view function smoothly, make sure the network connection is in good
condition.
3 In the Bed View window, you cannot view the over-limit alarms of physiological
parameters occurring on other beds. Besides, arrhythmia alarms and vital alarms will
be indicated only by alarm icons.
7.8.1 Opening the Bed View Window

Before opening the Bed View window, make sure the bed view function is configured on your
monitor. To open the Bed View window, select Menu> Display Setup and choose Bed View in
the View Selection list.
7.8.2 Settings of the Bed View Window

Click on the Bed View window to open the ViewBed Setup menu on which you can
z Assign a bed to be viewed by selecting the bed No. in the Bed No. list.
z Select the waveform to be displayed on the window in the Wave Type list.
z Use the buttons and to view more numeric information of parameters in the
window.
7.9 Changing Parameter and Waveform Colors

The user can set the display colors of parameter and waveform as desire. To change the display
color, please select Menu > Maintenance > User Maintain, enter the required password ABC.
Then select Color Select to make color changes on parameter and color.
7.10 User Configuration

Users can save the current monitor’s configuration, delete the saved user configuration and
rename it. Three pieces of user configuration can be saved in the monitor.
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To save the user configuration:

1. Select Menu > Maintenance > User Maintain, enter the required password ABC and then
select User Configure.
2. Click on Save, enter a file name for the configuration and confirm it. A message will display
after the operation.
To delete the user configuration:
2. Select the configuration file needed to delete from the list, click on Delete and confirm the
operation. A message will display after the operation.
To rename the user configuration:
2. Select a configuration file needed to rename from the list and click on Rename.
3. Enter a name for the configuration file and confirm it.
7.11 Default Configuration

To set default configuration, please select Menu > Default and choose a configuration (adult,
pediatric or neonate) based on your patient category. This configuration is factory configuration.
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Patient Monitor User Manual Monitoring ECG
Chapter 8 Monitoring ECG
8.1 Overview
The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the
monitor as a waveform and a numeric. This chapter also tells you about arrhythmia monitoring
and ST monitoring.
8.2 ECG Safety Information

WARNING
1 Do not come into contact with the patient, table, or the monitor during defibrillation.
2 Only use the ECG leads supplied by the manufacturer when using the monitor for
ECG monitoring.
3 When connecting the cables and electrodes, make sure no conductive part is in
contact with the ground. Verify that all ECG electrodes, including neutral electrodes,
are securely attached to the patient but not the conductive part or ground.
4 Check every day whether there is skin irritation resulted from the ECG electrodes. If
yes, replace electrodes every 24 hours or change their sites.
5 Place the electrode carefully and ensure a good contact.
6 Check if the lead connection is correct before monitoring. If you unplug the ECG cable
from the socket, the screen will display the error message “ECG LEAD OFF” and the
audible alarm is activated.
7 When using the monitor with the defibrillator or other high-frequency equipment,
please use defibrillator-proof ECG lead to avoid burn.
8 In order to avoid being burnt, please keep the electrodes far away from the radio knife
while using electrosurgical equipment.
9 When using Electrosurgery (ES) equipment, do not place an electrode near the
grounding plate of the Electrosurgery device: otherwise there will be a great deal of
interference with the ECG signal.
10 For patients with pacemakers, the pacing impulse analysis function must be switched
ON. Otherwise, the pacing impulse may be counted as normal QRS complex, which
results in failure of ECG LOST error detection.
11 The electrodes should be made of the same metal materials.
12 ECG cables can be damaged when connected to a patient during defibrillation. Check
cables for functionality before using them again.
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NOTE:
1 Interference from a non-grounded instrument near the patient and ESU interference
can cause inaccuracy of the waveform.
2 IEC/EN60601-1-2 (protection against radiation is 3v/m) specifies that the electrical
field density exceeding 1v/m may cause measurement error in various frequencies. It
is accordingly suggested that do not use equipment generating electrical radiation
near ECG/RESP monitoring devices.
3 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
4 If the pacemaker signals are beyond the claimed range, the heart rate may be
calculated incorrectly.
5 In the default settings of the monitor, the ECG waveforms are the first two waveforms
from top in the waveform area.
6 For measurements in or near the heart we recommend connecting the monitor to the
potential equalization system.
7 For protecting environment, the used electrodes must be recycled or disposed of
properly.
8.3 ECG Display

The figure below is for reference only.
The symbol “ķ”indicates lead name of display waveform: there are other leads for selection,
such as I, II, III, aVR, aVF, aVL, V. If you want to change the lead, please refer to section
Selecting Calculation Lead.
The symbol “ĸ” indicates waveform gain: there are several options, such as X0.125, X0.25,
X0.5, X1, X2, X4 and Auto. If you want to change it, please refer to section Changing the size of
the ECG Wave.
The symbol “Ĺ” indicates Filter setting, there are three options: monitoring, surgery, diagnosis.
If you want to change it, please refer to section Changing the ECG Filter Setting.
8.3.1 Changing the Size of the ECG Wave

If any of the displayed ECG waveform is too small or clipped, you can change the size of it on
the screen. First select ECG Wave Setup > ECG Gain, then select an appropriate factor from
the pop-up box to adjust the ECG waveform.
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X0.125 to make strength of ECG signal waveform of 1mV become 1.25mm;

X0.25 to make strength of ECG signal waveform of 1mV become 2.5mm;
X0.5 to make strength of ECG signal waveform of 1mV become 5mm;
X1 to make strength of ECG signal waveform of 1mV become 10mm;
Auto let the monitor choose the optimal adjustment factor for all the ECG waves.
8.3.2 Changing the ECG Filter Settings

The ECG filter setting defines how ECG waves are smoothed. An abbreviation indicating the
filter type is shown underneath the lead label on the monitor display. Filter settings do not affect
ST measurement.
To change the filter setting, in the ECG Setup menu, select Filter and then select the appropriate
setting.
– Monitor: Use this mode under normal measurement conditions.
– Surgery: The filter reduces interference to the signal. It should be used if the signal is
distorted by high frequency or low frequency interference. High frequency interference usually
results in large amplitude spikes making the ECG signal look irregular. Low frequency
interference usually leads to a wandering or rough baseline. In the operating room, the Filter
reduces artifacts and interference from electro-surgical units. Under normal measurement
conditions, selecting Surgery may suppress the QRS complexes too much and thus interfere with
the clinical evaluation of the ECG displayed on the monitor.
– Diagnos: Use when diagnostic quality is required. The unfiltered ECG wave is displayed so
that changes such as R-wave notching or discrete elevation or depression of the ST segments are
visible.
8.4 Using ECG Alarms

ECG alarms can be switched on and off and the changes to high and low alarm limits are just like
other measurement alarms, which are described in the Alarms section. Special alarm features
applying only to ECG are described here.
8.5 Selecting Calculation Lead

On the Normal interface, the users can select either 3 LEADS or 5 LEADS for this item. Normal
QRS complex should be:
The normal QRS should be either completely above or below the baseline and it should not
be biphasic. For paced patients, the QRS complexes should be at least twice the height of
pace pulses.
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The QRS should be tall and narrow.

The P-waves and the T-waves should be less than 0.2 mV.
8.6 Monitoring Procedure

8.6.1 Preparation
The skin is a poor conductor of electricity, therefore preparation of the patient's skin is important
to facilitate good electrode contact to skin.
Select sites with intact skin, without impairment of any kind.
Shave hair from sites, if necessary.
Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this
increases skin impedance).
Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and
grease.
8.6.2 Connecting ECG Cables

1. Attach clip or snap to electrodes prior to placement.
2. Put the electrodes on the patient. Before attaching, apply some conductive jelly on the
electrodes if the electrodes are not electrolyte self-supplied.
3. Connect the electrode lead to the patient's cable.
CAUTION
To protect the monitor from damage during defibrillation, for accurate ECG information
and to protect against noise and other interference, use only ECG electrodes and cables
specified by EDAN.
8.7 Selecting Lead Type

To change the lead type, please:
1. Select the ECG parameter area, open the ECG Setup menu;
2. Set Lead Type to 3 Leads, 5 Leads or 12 Leads based on the lead used.
8.8 Installing Electrodes

NOTE:
The following table gives the corresponding lead names used in Europe and America
respectively. (Lead names are represented by R, L, F, N, C, C1-C6 in Europe, whose
corresponding lead names in America are RA, LA, LL, RL, V, V1-V6.)
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AHA (American Standard) IEC (Europe Standard)

Electrode Labels Color Electrode Labels Color
RA White R Red
LA Black L Yellow
LL Red F Green
RL Green N Black
V Brown C White
V1 Brown/ Red C1 White/ Red
V2 Brown/ Yellow C2 White/ Yellow
V3 Brown/ Green C3 White/ Green
V4 Brown/Blue C4 White/ Brown
V5 Brown/Orange C5 White/ Black
V6 Brown/Purple C6 White/ Purple
8.8.1 Electrode Placement for 3-lead

Take the American standard for example, see the following figure:
RA placement - directly below the clavicle and near the right shoulder.
LA placement: directly below the clavicle and near the left shoulder.
LL placement - on the left hypogastrium.
Electrode Placement for 3-lead
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Take the American standard for example, see the following figure:
RA placement: directly below the clavicle and near the right shoulder.
LA placement: directly below the clavicle and near the left shoulder.
RL placement: on the right hypogastrium.
LL placement: on the left hypogastrium.
V placement: on the chest, the position depends on your required lead selection.
NOTE:
To ensure the patient safety, all leads must be attached to the patient.
For 5-lead, attach the V electrode to one of the indicated positions as below:
V1 On the 4th intercostal space at the right sterna margin.
V2 On the 4th intercostal space at the left sterna margin.
V3 Midway between V2 and V4 electrodes.
V4 On the 5th intercostal space at the left clavicular line.
V5 On the left anterior axillary line, horizontal with V4 electrode.
V6 On the left middle axillary line, horizontal with V4 electrode.
V3R-V6R On the right side of the chest in positions corresponding to those on the left.
VE Over the xiphoid position.
V7 On the 5th intercostal space at the left posterior axillary line of back.
V7R On the 5th intercostal space at the right posterior axillary line of back.
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V-Electrode Placement for 5-lead

Take the American standard for example. The 12-lead electrodes should be placed on extremities
and chest. The electrodes for extremities should be placed on the skin of legs or arms, the
electrodes placed on chest should follow the doctor’s advice. Please see the following figure.
- 69 -
8.8.4 Recommended ECG Lead Placement for Surgical Patients

WARNING
When using Electrosurgery (ES) equipment, leads should be placed in a position in equal
distance from Electrosurgery electrotome and the ES grounding plate to avoid cautery.
Electrosurgery equipment wire and ECG cable must not be tangled up.
Monitoring ECG leads are mainly used for monitoring the patient’s vital signs. When using the
patient monitor with other electrosurgery equipment, it is advised to use the counteracting
defibrillation ECG lead.
The placement of the ECG leads will depend on the type of surgery that is being performed. For
example, in an open chest surgery the electrodes may be placed laterally on the chest or on the
back. In the operating room, artifacts may affect the ECG waveform due to the use of ES
(Electrosurgery) equipment. To help reduce this you can place the electrodes on the right and left
shoulders, the right and left sides near the abdomen, and the chest lead on the left side at
mid-chest. Avoid placing the electrodes on the upper arms. Otherwise the ECG waveform will be
too small.
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NOTE:
1 If an ECG waveform is not accurate, while the electrodes are tightly attached, try to
change the lead.
2 Interference from a non-grounded instrument near the patient and ESU interference
can cause inaccuracy of the waveform.
8.9 ECG Menu Setup
8.9.1 Setting Alarm Source

To change the alarm source, please select ECG Setup > Alarm Source, then a pop-up box is
displayed:
HR: the monitor considers the HR as HR/PR alarm source;
PR: the monitor considers the PR as HR/PR alarm source;
AUTO: If the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG
measurement as the alarm source whenever the ECG measurement is switched on and at least one
ECG lead can be measured without a technical condition. The monitor will automatically switch
to Pulse as the alarm source if:
–a valid ECG lead can no longer be measured and
–a pulse source is switched on and available.
The monitor then uses the pulse rate from the measurement currently active as system pulse.
While Pulse is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG
lead becomes available again, the monitor automatically uses HR as alarm source.
8.9.2 Smart Lead Off

In 5 LEADS, 12 LEADS mode, if CH1 and CH2 cannot be measured because of the lead off or
other reasons, it can shift to other modes to collect an ECG waveform.
To change smart lead off setting, please select ECG Setup > Smart Leadoff, then a pop-up
menu is displayed.
8.9.3 Setting Beat Volume

Beat volume is from HR or PR, depending on your HR alarm setting. Five selections are
available: 0, 1, 2, 3, 4, 5. 5 indicates the maximum volume. 0 indicates the minimum volume.
To change the beat volume, first select ECG Setup > Beat Volume, and then select an
appropriate volume from the pop-up list.
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8.9.4 ECG Display

It varies with Lead Type. When Lead Type is set to 3 Leads, Display can be set to Normal, and
it can display one ECG waveform on the main screen.
When Lead Type is set to 5 Leads, Display can be set to Normal, Full-Scr and Half-Scr. Select
Normal to display two ECG waveforms on the main screen; select Full-Scr to display seven
ECG waveforms which occupy the area of seven waveforms on the main screen; Select Half-Scr
to display seven ECG waveforms on the screen, occupying the area of four waveforms.
NOTE:
If 3 Leads is selected in the ECG Setup menu, only Normal can be selected for Display
in the sub-menu.
8.9.5 Setting Pace Status

It is important to set the paced status correctly when you start monitoring ECG. To change the
paced status in the ECG Setup menu, select Pace to toggle between On or Off. When Pace is set
to On:
- Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as
extra QRS complexes.
|
̢Paced symbol is displayed as on the main screen.
NOTE:
1 When monitoring a patient with a pacemaker, set Pace to On. If monitoring a patient
without a pacemaker, set Pace to Off.
2 If Pace is set to On, the system will not perform some types of ARR analysis.
WARNING
Some pace pulses can be difficult to reject. When this happens, the pulses are counted
as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest
or some arrhythmias. Keep pacemaker patients under close observation.
8.9.6 ECG Calibration

This item is used to calibrate ECG waveform. When you select this item from ECG Setup menu
again, the ECG waveform calibration ends.
NOTE:
The device can’t be monitored during ECG calibration.
8.9.7 ECG Waveform Settings

To change this speed, select ECG Wave Setup > Sweep, then select an appropriate setting from
the pop-up list. The bigger the value is, the wider the waveform is.
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8.9.8 12 Leads ECG

When the monitor is installed with 12-lead, it can provide 3-lead, 5-lead and 12-lead ECG
monitoring functions.
8.10 ST Segment Monitoring

The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST
segment elevations and depressions. This information can be displayed in the form of ST numeric
and snippets on the monitor.
ST segment monitoring function is shut off by default. You can switch it to On when necessary.
When using the ST analysis function, the ST analysis results will be displayed on the right of the
main screen, please refer to the following figure.
NOTE:
The ST algorithm has been tested for accuracy of the ST segment data. The significance
of the ST segment changes need to be determined by a clinician.
8.10.1 Setting ST Analysis

To change ST analysis, please select ECG Setup > ST Analysis, then select On or Off from the
pop-up list.
8.10.2 ST Display
Your monitor screen may be configured to look slightly different from the illustrations.
ST I 0.08 aVR -0.09 V 0.04

II 0.10 aVL 0.03
III 0.02 aVF 0.06
NOTE:
1 When setting ST Analysis to on, the monitor should be in Diagnos mode.
2 ECG monitoring should be in Diagnos mode.
8.10.3 ST Analysis Alarm Setting

The user can select ECG Setup > ST Analysis > Alarm Setup to set the upper alarm limit and
lower alarm limit. ALM HI can be set to 0.2 mV ~ 2.0 mV, and ALM LO can be set to –2.0 mV
~ 0.2 mV. ALM HI should be higher than ALM LO.
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8.10.4 About ST Measurement Points

The ST value for each beat complex is the vertical difference between the ISO point and the ST
point, as shown in the diagram below. The isoelectric (ISO) point provides the baseline, and the
ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its
slope; as it is a fixed distance away from the ST point, it can be useful to help you position the ST
point correctly.
DEF POINT
The ST and ISO measurement points need to be adjusted when you start monitoring, and if the
patient's heart rate or ECG morphology changes significantly. Always ensure that ST
measurement points are appropriate for your patient. Abnormal QRS complex is not considered
in ST segment analysis.
8.10.5 Adjusting ST and ISO Measurement Points

Depending on your monitor’s configuration, the ST point can be positioned, too.
These two points can be adjusted by turning the knob. When adjusting ST measurement point, the
system will show the ST Measurement Point Window. The system displays the QRS complex
template in the window. It is adjustable for the highlight bar in the window. You may select ISO
or ST, switch the knob left or right to move the cursor line. When the cursor is at the required
position, you may select the base point or the measurement point.
8.11 Arr. Monitoring
8.11.1 Arrhythmia Analysis

The arrhythmia algorithm is used to monitor ECG of patients in clinics, and detect the changes of
heart rate and ventricular rhythm, and also save arrhythmia events and generate alarming
information. Arrhythmia algorithm can monitor paced and non-paced patients. Qualified
personnel can use arrhythmia analysis to evaluate patient’s condition (such as heart rate, PVCs
frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting change of ECG,
arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia.
- 74 -
The monitor can support up to 16 different arrhythmia analyses.

ARR Types Occurring Condition
ASYSTOLE No QRS is detected for 4 consecutive seconds
VFIB/VTAC Ventricular tachycardia: The RR interval of 4-second fibrillation

wave or 5 consecutive ventricular beats is less than 600 ms.
VT>2 3< the number of cluster PVCs < 5
COUPLET 2 consecutive PVCs
BIGEMINY Vent Bigeminy
TRIGEMINY Vent Trigeminy
A type of single PVC under the condition that HR<100ˈR-R
R ON T interval is less than 1/3 the average interval, followed by a
compensating pause of 1.25X the average R-R interval (the next
R wave advances onto the previous T wave).
PVC Single PVC detected in normal heartbeats.
Adult: 5 consecutive QRS complex, RR interval < 0.5s (HR
TACHY range: 120~300bpm).
Pediatric/neonatal: 5 consecutive QRS complex, RR interval <
0.375s (HR range: 160~350bpm).
Adult: 5 consecutive QRS complex, RR interval 1.5s (HR
BRADY range: 15~40bpm).
Pediatric/neonatal: 5 consecutive QRS complex, RR interval
1s (HR range: 15~60bpm).
When HR is less than 120 beats/min., no heart beat is tested
MISSED
during the period 1.75 times of the average RR interval; or
BEATS
When HR is 120 beats/min, no beat is tested within 1 second.
IRR IRREGULAR RHYTHM: The patient has irregular heart rate.
PNC PACE NOT CAPTURE: After the pacemaker is paced, QRS

complex can not be detected during 300ms.
PNP PACER NOT PACED: After the QRS complex, no pace is

detected during 1.75 times of RR interval.
VBRADY VENTRICULAR BRADYCARDIA: The interval of 5

consecutive ventricular wave is more than 1000 ms.
VENT VENTRICULAR RHYTHM: The interval of 5 consecutive

ventricular wave ranges from 600 ms to 1000 ms.
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8.11.2 ARR Analysis Menu
8.11.2.1 Switching ARR Analysis On and Off

To switch ARR Analysis on or off, in the ECG Setup menu, select ARR Analysis to toggle
between On and Off from the popup interface.
8.11.2.2 PVCs Alarm

Select On in the menu to enable prompt message when an alarm occurs; select Off to disable the
alarm function, and there will be a symbol beside PVCs.
WARNING
When the PVCs Alarm is set to OFF, the monitor won’t give an alarm prompt even if an
alarm occurs. In order to avoid endangering the patient’s life, the user should use this
function cautiously.
8.11.2.3 ARR Relearning

Pick this item to start a learning procedure, and ECG ARR LEARNING is displayed on the
screen. The ECG ARR LEARNING will start automatically in the following status:
z Changing lead type;
z Connection leads;
z Updating the patients;
z Starting ARR learning manually;
z After the ARR analysis is switched on;
z The module is set to on;
z Calibration mode is changed to normal measurement mode;
z Exiting the Demo mode;
z Exiting the standby mode;
8.11.2.4 ARR Alarm

The users can switch on or off all arrhythmia alarms by selecting ECG Setup > ARR Analysis >
ARR Alarm. And some arrhythmia alarms can be individually switched on or off. They are:
ASYSTOLE, VFIB/VTAC, R-ON-T, VT>2, COUPLET, PVC, BIGEMINY, TRIGEMINY,
TACHY, BRADY, MISSED BEATS, IRR, PNC, PNP, VBRADY and VENT.
To switch individual alarm on or off, select ECG Setup > ARR Analysis > ARR Alarm. The
user can set the individual ARR alarm from the popup interface.
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8.12 12-Lead ECG Monitoring

8.12.1 Diagnosis Function
If iM80 is equipped with 12 leads monitoring, the device has automatically diagnosis function.
To perform this function, please:
1 Set Lead Type in the ECG Setup menu to 12 Leads and set Display in the ECG Setup
menu to 12 Leads.
2 Select the ECG Analysis shortcut key on the screen.
3 The Diagnosis Review interface is displayed, shown in figure a. And the diagnosis result is
displayed on the interface after approximately 10 seconds, shown in figure b.
Figure a
Figure b
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Figure b shows analysis time, HR (heart rate), P/QRS/T Axis, RR Interval, RVS/SV1 Amp
(RVS/SV1 amplitude), QRS Duration, RV5+SV1 Amp (RV5+SV1 amplitude), QT/QTC Interval
and Diagnosis code.
More information about diagnosis review, please refer to Section 12-lead Diagnosis Review.
8.12.2 Measurement and Interpretation

The measurement function provides the automatic measurement of these common parameters,
such as heart rate, PR interval, QRS complex duration, QT interval, P/QRS/T axis, RV5/SV1
amplitude etc. The interpretation function provides the automatic diagnosis of hundreds of
abnormal cases, such as Arrhythmia, AV block, ventricular conduction block, myocardial
infarction, ventricular hypertrophy and atria enlargement, ST-T abnormality and electrical axes
deviation.
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Patient Monitor User Manual Monitoring RESP
Chapter 9 Monitoring RESP
9.1 Overview
The monitor measures respiration from the amount of thoracic impedance between two ECG
electrodes. The change of impedance between the two electrodes, (due to the thoracic movement),
produces a respiratory waveform on the screen.
9.2 RESP Safety Information

WARNING
1 If you do not set the detection level for the respiration correctly in manual detection
mode, it may not be possible for the monitor to detect apnea. If you set the detection
level too low, the monitor is more likely to detect cardiac activity, and to falsely
interpret cardiac activity as respiratory activity in the case of apnea.
2 The respiration measurement does not recognize obstructive and mixed apneas - it
only indicates an alarm when a pre-adjusted time has elapsed since the last detected
breath.
3 If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated
Immunity 3V/m), field strengths above 1V/m may cause erroneous measurements at
various frequencies. Therefore it is recommended to avoid the use of electrically
radiating equipment in close proximity to the respiration measurement unit.
4 Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect
breaths or may otherwise be counted as breaths. In some instances, the breath rate
may also correspond to the heart rate making it difficult to determine if the signal is
due to breathing or the cardiac cycle. Do not rely on RESP monitoring as the sole
method for detecting cessation of breathing. Follow hospital guidelines and best
clinical practices for apnea detection including monitoring additional parameters that
indicate the patient’s oxygenation status, such as etCO2 and SpO2.
NOTE:
The RESP monitoring is not recommended to be used on patients who are very active, as
this can cause false alarms.
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9.3 Resp Display

Resp 30
8
14
9.4 Electrode Placement for Monitoring Resp
Correct patient skin preparation techniques for electrode placement are important for Resp
measurement: you will find this information in the chapter on Monitoring ECG.
The Resp signal is always measured between two of the ECG electrodes. There are two standard
ECG leads for selection: I lead (RA and LA) and II lead (RA and LL).
Electrodes Placement for 5-lead
9.5 Cardiac Overlay

Cardiac activity that affects the Resp waveform is called cardiac overlay. It happens when the
Resp electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrode
placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart
in the line between the respiratory electrodes. This is particularly important for neonates.
9.6 Chest Expansion

Some patients, especially neonates, expand their chests laterally. In these cases it is best to place
the two respiratory electrodes in the right mid-axillary and left lateral chest areas at the patient’s
maximum point of breathing movement to optimize the respiratory wave.
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9.7 Abdominal Breathing

Some patients with restricted chest movement breathe mainly abdominally. In these cases, you
may need to place the left leg electrode on the left abdomen at the point of maximum abdominal
expansion to optimize the respiratory wave.
NOTE:
Place the red and green electrodes diagonally to optimize the respiration waveform.
Avoid the liver area and the ventricles of the heart in the line between the RESP
electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow. This is
particularly important for neonates.
9.8 Selecting Resp Lead

To change Resp lead, in the Resp Setup menu, select Resp Lead to pick up the appropriate lead
from the pop-up list.
9.9 Changing Hold Type

To change the calculation mode, in the Resp Setup menu, set Hold Type to Manual or Auto.
When it is set to the AUTO mode, Hold High and Hold Low are unavailable, and the monitor
can calculate the respiration rate automatically. When it is set to the Manual mode, you can
adjust the broken lines in RESP area by the Hold High and Hold Low items.
9.10 Changing the Size of the Respiration Wave

Select the Resp waveform area to open the Resp Wave Setup menu:
z Select AMP, then choose an appropriate value. The value is bigger, the waveform amplitude
is higher.
z Select Sweep: select an appropriate setting from the pop-up list.
9.11 Using Resp Alarms

Resp alarms can be switched on and off and the high and low alarm limits can be changed just
like other measurement alarms, as described in the Alarms chapter.
9.12 Changing the Apnea Time

The apnea alarm is a high priority red alarm used to detect apneas. The apnea alarm delay time
defines the time period between the point where the monitor cannot detect any respiration activity
and the indication of the apnea alarm.
1. In the Resp Setup menu, select Apnea Alm.
2. Select the appropriate setting from the popup list.
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Patient Monitor User Manual Monitoring SpO2
Chapter 10 Monitoring SpO2
10.1 Overview
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of
finger sensor and SpO2 measuring unit. SpO2 Plethysmogram measurement is employed to
determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% of the
hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the
blood has a SpO2 oxygen saturation of 97%. The SpO2 numeric on the monitor will read 97%.
The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with
oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse
rate signal and a plethysmogram wave.
10.2 SpO2 Safety Information

WARNING
1 If the SpO2 sensor cannot work properly, please reconnect the sensor or change a
new one.
2 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is
damaged and return them to the vendor.
3 Prolonged and continuous monitoring may increase the risk of unexpected change of
dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive
putrescence, and so on. It is especially important to check the sensor placement of
neonate and patient of poor perfusion or immature dermogram by light collimation and
proper attaching strictly according to changes of the skin. More frequent examinations
may be required for different patients.
4 Tissue damage may be caused by incorrect application or prolonged measurement
duration using the sensor (more than 4 hours). Inspect the sensor periodically
according to the sensor user manual.
5 Use only EDAN permitted sensors and extension cables with the monitor. Other
sensors or extension cables may cause improper monitor performance and/or minor
personal injury.
NOTE:
1 Make sure the nail covers the light window. The wire should be on the backside of the
hand.
2 SpO2 waveform is not proportional to the pulse volume.
3 Avoid placing the sensor on extremities with an arterial catheter, or intravascular
venous infusion line.
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4 Don’t use the functional tester to access the SpO2 accuracy.

5 The device is calibrated to display functional oxygen saturation.
6 The materials with which the patient or any other person can come into contact
conform with the standard of EN ISO 10993-1:2003.
10.3 Measuring SpO2

1. Select the correct patient category setting (adult/pediatric and neonatal), as this is used to
optimize the calculation of the SpO2 and pulse numeric.
2. During measurement, ensure that the application site:
– has a pulsatile flow, ideally with a good circulation perfusion.
– has not changed in its thickness, causing an improper fit of the sensor.
10.4 Measurement Procedure

1. Switch on the monitor.
2. Attach the sensor to the appropriate site of the patient finger.
3. Plug the connector of the sensor extension cable into the SpO2 socket on the SpO2 module.
Mounting of the Sensor
WARNING
Inspect the application site every two to three hours to ensure skin quality and correct
optical alignment. If the skin quality changes, move the sensor to another site. Change
the application site at least every four hours.
NOTE:
Injected dyes such as methylene blue or intravascular dyshemoglobins such as
methemoglobin and carboxyhemoglobin may lead to inaccurate measurements.
Interference can be caused by:
z High levels of ambient light or strobe lights or flashing lights (such as fire alarm lamps).
(Hint: cover application site with opaque material.)
z High-frequency electrical noise, including electro-surgical apparatus and defibrillators
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z Intravascular dye injections

z Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and
methemoglobin
z Excessive patient movement and vibration
z Improper sensor application
z Low perfusion or high signal attenuation
z Venous pulsation
z Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or
intravascular line
10.5 Understanding SpO2 Alarms

This refers to SpO2 specific alarms. See the Alarms section for general alarm information. SpO2
offers high and low limit alarms, and the users can adjust them.
10.6 Adjusting Alarm Limits

In the SpO2 Setup menu, select Alarm Setup:
z Set the SpO2 High Alarm Limit to an appropriate value from the popup interface.
z Set the SpO2 Low Alarm Limit to an appropriate value from the popup interface.
WARNING
High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a
consideration do NOT set the high alarm limit to 100%, which is equivalent to switching
the alarm off.
10.7 Setting SpO2 as Pulse Source

1. In the PR Setup menu, select PR Source;
2. Select SpO2 from the pop-up list.
10.8 Setting Pitch Tone

If tone modulation is on, the PR sound lowers when the SpO2 level drops. In the SpO2 Setup
menu, select pitch tone to toggle between On and Off.
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10.9 Setting Sensitivity

The different sensitivity indicates different refresh frequency. High indicates the refresh
frequency of SpO2 value is the most frequent. To change the sensitivity, please follow the steps:
1 Select the SpO2 Setup menu;
2 Select Sensitivity on the interface and select the desired sensitivity from the popup list.
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Patient Monitor User Manual Monitoring PR
Chapter 11 Monitoring PR
11.1 Overview
The pulse numeric counts the arterial pulsations that result from the mechanical activity of the
heart in beats per minute (bpm). You can display a pulse from any measured SpO2 signal or any
arterial pressure.
11.2 Setting PR Source

The monitor provides PR source options. You can select SpO2 or arterial pressure labels as the
PR source in the PR Source list on the PR Setup menu.
NOTE:
In the PR Source list, an arterial pressure label accompanied with a label with brackets
indicates this label is in conflict. Do not select a conflicting label as the PR source.
11.3 Setting PR Volume

Six selections are available: 0, 1, 2, 3, 4, and 5. 5 indicates the maximum volume. 0 indicates no
sound. You can change PR Volume in the PR Setup menu.
11.4 Using Pulse Alarms

You can change pulse rate alarm limits in the PR Setup menu by selecting Alarm Setup. Pulse
alarms are only generated when the active alarm source is set to PR, a pulse source is set as
system pulse and pulse alarms are switched on.
11.5 Selecting the Active Alarm Source

In most cases, the HR and Pulse numerics are identical. In order to avoid simultaneous alarms on
HR and Pulse, the monitor uses either HR or Pulse as its active alarm source. To change the
alarm source, select Alarm Source in the HR/Pulse Alarms menu, then select
z HR: if you want HR to be the alarm source for HR/Pulse.
z PR: if you select Pulse as the active alarm source, the monitor will prompt you to confirm
your choice. Be aware that if you select Pulse as the alarm source, all arrhythmia and ECG
HR alarms are switched off.
z AUTO: if the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG
measurement as the alarm source whenever the ECG measurement is switched on and at least
one ECG lead can be measured without a technical alarm condition. The monitor will
automatically switch to Pulse as the alarm source.
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Patient Monitor User Manual Monitoring NIBP
Chapter 12 Monitoring NIBP
12.1 Overview
This monitor uses the oscillometric method for measuring NIBP. It can be used for adult,
pediatric and neonatal patients.
Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff
deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks
through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase
in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.
In adult and pediatric mode, the blood pressure measurements determined with this device comply
with the American National Standard for Electronic or Automated Sphygmomanometers
(ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to
auscultatory measurements in a representative patient population. For the auscultatory reference,
the fifth Korotkoff sound was used to determine the diastolic pressure.
In neonatal mode, the blood pressure measurements determined with this device comply with the
American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI
SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial
measurements in a representative patient population.
12.2 NIBP Safety Information

WARNING
1 Do not measure NIBP on patients with sickle-cell disease or any condition where skin
damage has occurred or is expected.
2 Use clinical judgement to decide whether to perform frequent unattended blood
pressure measurements on patients with severe blood clotting disorders because of
the risk of hematoma in the limb fitted with the cuff.
3 Ensure that the correct setting is selected when performing measurements. It may be
dangerous for the children to use an over pressure level.
4 The equipment is suitable for use in the presence of electrosurgery.
5 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.
6 Before starting a measurement, verify that you have selected a setting appropriate for
your patient (adult, pediatric or neonatal.)
7 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
This could cause tissue damage around the catheter when infusion is slowed or
blocked during cuff inflation.
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WARNING
8 Make sure that the air conduit connecting the blood pressure cuff and the monitor is
neither blocked nor tangled.
9 Do not attach the cuff to a limb being used for IV infusions as the cuff inflation can
block the infusion, potentially causing harm to patient.
NOTE:
1 It is suggested that the user should not start NIBP measuring when the low battery
displays, or the monitor may be turned off automatically.
2 If you spill liquid onto the equipment or accessories, particularly if there is a chance
that it can get inside the tubing or the measurement device, contact your service
personnel.
3 Continuous use of the automatic measuring mode for short intervals may lead to the
discomfort of patient.
12.3 Introducing the Oscillometric NIBP Measurement

Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff
deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks
through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase
in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.
12.4 Measurement Limitations

Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240
bpm, or if the patient is on a heart-lung machine.
The measurement may be inaccurate or impossible in the following situations:
z A regular arterial pressure pulse is hard to detect.
z Patients with cardiac arrhythmias.
z Patients with excessive and continuous movement such as shivering or convulsions.
z Patients with rapid blood pressure changes.
z Patients with severe shock or hypothermia that reduces blood flow to the peripheries.
z Patients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations
coming from the artery.
z Patients on an edematous extremity.
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12.5 Measurement Methods

There are three methods of measuring NIBP:
z Manual - measurement on demand.
z Auto - continually repeated measurements (between 1 and 480 minute adjustable interval).
z Sequence - the measurement will run consecutively in five minutes, then the monitor enters
manual mode.
WARNING
Prolonged non-invasive blood pressure measurements in Auto mode may be associated
with purport, ischemia and neuropathy in the limb wearing the cuff. When monitoring a
patient, examine the extremities of the limb frequently for normal color, warmth and
sensitivity. If any abnormality is observed, stop the blood pressure measurements.
12.6 Measurement Procedures

1. Connect the air hose and switch on the monitor.
2. Apply the blood pressure cuff to the patient's arm or leg and follow the instructions below.
Ensure that the cuff is completely deflated.
Apply the appropriate size cuff to the patient (About the cuff size selection, please refer to
Section NIBP accessories), and make sure that the symbol "" is over the artery. Ensure that
the cuff is not wrapped too tightly around the limb. Excessive tightness may cause
discoloration and eventual ischemia of the extremity.
NOTE:
The width of the cuff should be either approximately 40% of the limb circumference (50%
for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long
enough to encircle 50-80% of the limb. The wrong size of cuff can cause erroneous
readings. If the cuff size is in question, use a larger cuff.
Cuff Usage
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3. Connect the cuff to the air tubing.

4. Check whether the patient mode is appropriately selected. Access the Patient Setup menu
from Menu. Turn the knob to select the required patient Type in the Patient Info. menu.
5. Select a measurement mode in the NIBP Setup menu. Refer to section Operation Prompts
for details.
6. Press the button on the front panel to start a measurement.
12.7 Operation Prompts

1. Manual Measuring
Access the NIBP Setup menu and set the Measure Mode item to Manual. Then press the
button on the front panel to start a manual measurement.
During the idle period of measurement process, press the button on the front panel at
any time to start a manual measurement. Then press the button on the front panel to stop
manual measurement and the system continues to execute auto measurement program according
to the selected time interval.
2. Automatical Measurement
Access the NIBP Setup menu and set the Measure Mode item to Auto, then press the
button on the front panel to start the automatical measurement according to the selected time
interval.
3. Continuous measurement
Access the NIBP Setup menu and pick the Continual item to start a continuous measurement.
The continuous measurement will last 5 minutes.
4. Stopping continuous measurement
During continuous measurement, press the button on the front panel at any time to stop
continuous measurement.
12.8 Correcting the Measurement if Limb is not at Heart Level

To correct the measurement if the limb is not at heart level to the displayed value:
Add 0.75mmHg (0.10kPa) for each centimeter Deduct 0.75mmHg (0.10kPa) for each
higher or centimeter lower or
Add 1.9mmHg (0.25kPa) for each inch higher Deduct 1.9mmHg (0.25kPa) for each inch
lower
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12.9 NIBP Alarm

When NIBP Alarm is set to On, the physiology alarm occurs if any measurement value of
Systolic pressure, Mean pressure, Diastolic pressure exceeds alarm limit. The users can adjust the
alarm limit by accessing NIBP Setup > Alarm Setup > Sys Alarm/Map Alarm/Dia Alarm.
12.10 Resetting NIBP

When the pressure does not work properly and the system fails to give a message for the problem,
pick Reset in the User Maintain > NIBP Maintain menu to activate self-test procedure, and
thus restore the system from abnormal performance.
12.11 Calibrating NIBP

NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated on a yearly
interval by a qualified service professional. See the Service Manual for details.
12.12 Leak Test

This item is used for leak test. Turn the knob to pick the Leak Test item in the User Maintain >
NIBP Maintain menu to start the air leakage test. When the item is selected, it will change into
Stop. If this item is selected again, the system will stop air leakage test. And the item returns to
Leak Test.
WARNING
This pneumatic test other than being specified in the EN 1060-1 standard is to be used by
the user to simply determine whether there are air leaks in the NIBP airway. If at the end
of the test the system gives the prompt that the NIBP airway has air leaks, please contact
the manufacturer for repair.
12.12.1 Procedure of Leak Test

z Connect the cuff securely with the socket for NIBP air hole.
z Wrap the cuff around the cylinder of an appropriate size.
z Access User Maintain > NIBP Maintain.
z Turn the knob to the Leak Test item and press the item. Then the prompt of Leak
Testing will appear indicating that the system has started performing leak test.
For iM70/iM80 with the Omron module:
The system will automatically inflate the pneumatic system to about 180 mmHg
(285mmHg for Omron Module). After 20 seconds (4 minutes for Omron Module), the
system will automatically open the deflating valve, which marks the completion of a
pneumatic measurement.
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For iM50/iM60/iM70 with the EDAN module:

The system will automatically inflate the pneumatic system to about 180 mmHg. After
20 seconds, the system will automatically open the deflating valve, which marks the
completion of a pneumatic measurement.
For iM80 with the EDAN module:
The system will automatically inflate the pneumatic system to about 180mmHg. After
20 to 40 seconds, if system leakage has detected, the system will automatically open
the deflating valve to stop the leak test and indicates NIBP Leak. If no system leakage
is detected when the pneumatic system is inflated to 180mmHg, the system will
perform a deflation to an approximate value of 40mmHg and subsequently perform
the second phase leak test. After 20 to 40 seconds, the system will automatically open
the deflating valve and provide corresponding indication based on the test result.
z If the alarm information of NIBP Leak appears, it indicates that the airway may have
air leaks. In this case, the user should check for loose connection. After confirming
secure connections, the user should re-perform the pneumatic test. If the failure prompt
still appears, please contact the manufacturer for repair.
Diagram of NIBP Air Leakage Test
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Patient Monitor User Manual Monitoring TEMP
Chapter 13 Monitoring TEMP
13.1 Overview
Body temperature is measured by means of a thermistor probe (a semiconductor whose resistance
changes with temperature) that is inserted in the rectum.
Two TEMP probes can be used simultaneously to measure two TEMP values, and get the
temperature difference. The standard configuration is axilla sensor for adult.
13.2 TEMP Safety Information

WARNING
1 Verify probe cables fault detection before the beginning of monitoring phase. Unplug
the temperature probe cable of the channe1 from the socket, and then the screen will
display the error message TEMP T1 Sensor Off and the audible alarm is activated. It
is the same to the other channel.
2 Take the TEMP probe and cable carefully. When they are not in use, you should coil
up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled,
it may cause mechanical damage to the probe and the cable.
13.3 TEMP Monitoring Setup

With a reusable TEMP probe you can plug the probe directly into the monitor. Apply the TEMP
probes securely to the patient. Switch on the monitor.
It takes 2 min ~ 3 min for the body temperature to stabilize.
13.4 Calculating Temp Difference

The monitor can calculate and display the difference between two temperature values by
subtracting T2 from T1. The difference is labeled TD.
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Patient Monitor User Manual Monitoring Quick TEMP
Chapter 14 Monitoring Quick TEMP*

*not available in the U.S.A., Canada, UK and Germany
14.1 Overview
Quick temperature measurement is to establish thermal balance between probe and human body.
When the probe is placed on the measurement site until a steady reading is available - after
approximately three minutes for oral and rectal measurements and five minutes for axillary
measurements. And the measurement temperature is the monitoring temperature. The temperature
curve in this process has a certain discipline. The approximatively actual temperature curve can
be simulated by temperature data sampled earlier. The temperature at thermal balance is
calculated through the specific algorithm based on the curve.
The monitor can only measure temperature of adult and pediatric patients. If the user measures
temperature of neonatal patient, the monitor will not display data. The oral/axillary sensor and
rectal sensor are of standard configuration.
14.2 Quick TEMP Safety Information

WARNING
1 To ensure optimal accuracy, always confirm that the correct mode and alarm limit are
selected. Changing the measure position may lead to the change of alarm limit.
2 Verify probe cables fault detection before the beginning of monitoring phase. Unplug
the temperature probe cable from the socket, and then the screen will display the
error message TEMP SENSOR OFF and the audible alarm is activated.
3 Take the TEMP probe and cable carefully. When they are not in use, you should coil
up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled,
it may cause mechanical damage to the probe and the cable.
4 The calibration of the temperature module is necessary every two years (or as
frequently as dictated by your Hospital Procedures Policy). When you need to
calibrate the temperature measurement, please contact the manufacturer.
5 Patient actions may interfere with accurate oral temperature readings. Ingesting hot or
cold liquids, eating food, chewing gum or mints, brushing teeth, smoking or
performing strenuous activity may affect temperature readings for up to 20min after
activity has ended.
6 Do not take an axillary temperature through patient’s clothing. Direct probe cover to
skin contact is required.
7 Biting the sensor tip while taking a temperature may result in damage to the sensor.
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WARNING
8 Make sure disposable TEMP sensor covers are used to limit patient
cross-contamination. The use of any other probe cover may produce temperature
measurement errors or result in inaccurate readings.
9 Quick Temp measurement isn’t suitable for use during defibrillation.
14.3 Measuring Procedure

14.3.1 Measurement for Oral Temperature
1. Ensure the oral probe (white probe) and probe well are installed.
2. Remove the probe from the probe well.
3. Observe the oral mode indicator on the screen (flashing head icon).
If this icon is not flashing, press the Measure Pos button and set it to Oral until the head icon
appears.
4. Load the probe cover.
5. Place the probe tip deep into the patient’s sublingual pocket as shown in the following figure.
Sublingual Pocket
Measuring Position in Mouth
6. Do not hand the probe to the patient to place in his or her own mouth.
7. Always hold the probe in place, maintaining tissue contact until temperature is complete.
If necessary, repeat the measurement procedure shown above.
- 95 -
NOTE:
1 After one measurement, the user should put the sensor well to the sensor bracket
and then take it out for starting a new measurement.
2 To ensure optimal accuracy, always confirm that the correct measurement position is
selected.
14.3.2 Measurements for Rectal Temperatures

1. Ensure that the rectal probe (red probe) and probe well are installed.
2. Remove the red probe from the probe well.
3. Observe the Rectal Mode indicator on the display (flashing lower body icon).
4. Load a probe cover. Apply lubricant if desired.
5. Separate the buttocks and gently insert the probe only 1.5cm (5/8 inch), less for infants and
children.
Measuring Position in Rectal
WARNING
Incorrect insertion can cause bowel perforation.
14.3.3 Measurements for Axillary Temperatures

1. Ensure that the white probe and probe well are installed.
2. Remove the probe from the probe well.
3. Press Quick TEMP Setup > Measure Pos and select the Axillary mode.
4.Observe the axillary mode indicator on the display (flashing axillary icon).
5. Load a probe cover.
6. Adjust clothing to visualize the axilla.
7. Avoid folds in the axilla and place the probe tip vertically as high as you can as shown.
8. Place the arm at the patient’s side. Hold in this position without movement of the arm or probe
during the measurement cycle.
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Measuring Position in Axillary
NOTE:
Do not take an axilliary temperature through the patient’s clothing. Direct contact
between the patient’s skin and the probe is required.
To obtain accurate rectal temperature, use the white temperature probe.
14.4 Changing Temp Unit

To change Temp Unit, please:
1 Select the Quick Temp Setup menu to open it and select Unit on the interface.
2 Select the appropriate unit from the popup list.
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Patient Monitor User Manual Monitoring IBP
Chapter 15 Monitoring IBP
15.1 Overview
IBP is measured by means of a catheter inserted directly into the circulatory system. A pressure
transducer connected to the catheter converts the mechanical force exerted by the blood into an
electrical signal, which is displayed graphically as pressure versus time on a monitor screen or
numerically on digital display.
The monitor measures direct blood pressure of one selected blood vessel through two channels or
four channels, and displays waveforms and pressure of measured direct blood pressure (SYS,
DIA and MAP).
15.2 IBP Safety Information

WARNING
1 The operator should avoid contact with the conductive parts of the appurtenance
when it is connected or applied.
2 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.
3 Disposable IBP transducer or domes should not be reused.
4 If any kind of liquid, other than solution to be infused in pressure line or transducer, is
splashed on the equipment or its accessories, or enters the transducer or the monitor,
contact the Hospital Service Center immediately.
NOTE:
1 Use only the pressure transducer listed in the IBP Accessories
2 Calibrate the instrument either whenever a new transducer is used, or as frequently
as dictated by your Hospital Procedures Policy.
15.3 Monitoring Procedures

Preparatory steps for IBP measurement:
1. Plug the pressure cable into the corresponding socket and switch on the monitor.
2. Flushing through the system with normal saline solution. Ensure that the system is free of air
bubbles.
3. Connect the patient catheter to the pressure line, making sure that there is no air present in
the catheter or pressure line.
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4. Position the transducer so that it is at the same level with the patient’s heart, approximately
mid-axillary line.
5. For the label name selection, please refer to Selecting a Pressure for Monitoring.
6. To zero the transducer, please refer to Zeroing the Pressure Transducer.
WARNING
If there are air bubbles in the pressure line or the transducer, you should flush the system
with the solution to be infused.
15.4 Selecting a Pressure for Monitoring

Tell the monitor which pressure you want to monitor by selecting its pressure label. The label is a
unique identifier for each type of pressure. When you choose a label, the monitor uses that label’s
stored settings, for example color, wave scale and alarm settings. The label also determines which
algorithm is used to process the pressure signal, so an incorrect label can lead to incorrect
pressure values. To select the label, please refer to the following table:
Label Description
ART Arterial blood pressure
PA Pulmonary artery pressure
CVP Central venous pressure
ICP Intracranial pressure
LAP Left atrial pressure
RAP Right atrial pressure
P1-P2 Alternative non-specific pressure labels
15.5 Zeroing the Pressure Transducer

To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in
accordance with your hospital policy (at least once per day). You must perform a zero:
z When you use a new transducer or tubing
z Every time you reconnect the transducer cable to the monitor;
z If you think the monitor’s pressure readings are not correct.
When using a pressure module, the zero information is stored in the module.
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15.6 Zeroing a Pressure Measurement

The zeroing procedure is listed as below:
1. Turn off the stopcock to the patient.
2. Vent the transducer to atmospheric pressure, to compensate for the static and atmospheric
pressure exerted on the transducer.
3. In the setup menu for the pressure, select Zero.
4. When you see the message Zero Ok, please close the stopcock to atmospheric pressure, and
open the stopcock to the patient.
15.7 Troubleshooting the Pressure Zeroing (Taking Art for

Example)
The status message lists the probable cause of an unsuccessful calibration.
Message Corrective Action
Art ZERO FAIL Make sure that the transducer is not attached to the patient
Art SENSOR OFF, FAIL Make sure that transducer is not off, and then proceed
zeroing
IN DEMO, FAIL Make sure that the monitor is not in DEMO mode. Contact
service technician if necessary
PRESSURE OVER RANGE, Make sure that the stopcock is vented to atmosphere. If the
FAIL problem persists, please contact service technician
PULSATILE PRESSURE Make sure that the transducer is vented to air, not connected
ZERO FAIL to a patient, and try again.
15.8 IBP Pressure Calibration

1. Mercury calibration should be performed by the biomedical engineering department either
whenever a new transducer is used, or as frequently as dictated by your Hospital Procedures
Policy.
2. The purpose of the calibration is to ensure that the system gives you accurate measurements.
3. Before starting a mercury calibration, a zero procedure must be performed.
If you need to perform this procedure yourself, you will need the following equipment: Standard
sphygmomanometer, 3-way stopcock and Tubing (approximately 25 cm long).
The calibration procedure is listed below:
1. Close the stopcock that was open to atmospheric pressure for the zero calibration.
2. Attach the tubing to the sphygmomanometer.
- 100 -
3. Ensure that connection to patient is off.

4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient
catheter.
5. Open the port of the 3-way stopcock to the sphygmomanometer.
6. Select the channel to be calibrated in the menu and select the pressure value to which the IBP
is to be adjusted.
7. Inflate to make the mercury bar rise to the setup pressure value.
8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the
mercury calibration.
9. Press the Start button, the device will begin calibrating.
10. Wait for the calibrated result. You should take corresponding measures based on the prompt
information.
11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve.
2 5
1: Hydrargyrum pressure meter; 2: 3-way connector; 3: 3-way stopcock; 4: Pressure transducer; 5:

Pressure transducer interface cable; 6: Monitor
IBP Calibration
15.9 Troubleshooting the Pressure Calibration

The status line lists the probable reasons of an unsuccessful calibration.
Causes Corrective Action
Sensor Off, Fail! Make sure that sensor is not off, and then start the calibration.
Contact service technician if necessary.
Unable to calibrate in Demo Make sure that the monitor is not in DEMO mode. Contact
Mode. service technician if necessary.
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Pressure out of normal range, Make sure that you have selected transducer value in IBP
fail. CAL, and then start the calibration. Contact service technician
if necessary.
Pulsate Pressure Calibration Fail Make sure that pressure value shown by hydrargyrum
pressure meter is changeless. Contact service technician if
necessary.
15.10 IBP Alarm

When Alarm Switch is set to On, the physiology alarm occurs if any measurement value of
Systolic pressure, Mean pressure, or Diastolic pressure exceeds alarm limit. Users can adjust the
alarm limit by accessing XX Options (XX stands for the label name) > Setup > SYS Alarm /
MAP Alarm / DIA Alarm.
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Patient Monitor User Manual Monitoring CO2
Chapter 16 Monitoring CO2

16.1 Overview
The monitor provides the sidestream and mainstream methods for CO2 monitoring. EDAN
module and Respironics Sidestream CO2 module are used for sidestream measuring, and
Respironics Mainstream CO2 module is used for mainstream measuring.
The principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb
4.3m infrared ray. Absorption intensity is proportional to CO2 concentration of patient sample,
the CO2 concentration will compute according to the detecting CO2 absorption intensity of patient
sample.
z Sidestream measurement takes a sample of the respiratory gas with a constant sample flow
from the patient’s airway and analyzes it with a remote CO2 sensor. You can measure
Sidestream CO2 using the monitor’s built-in CO2 measurement.
z Mainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted
into the patient’s breathing system.
16.2 CO2 Safety Information

WARNING
1 Do not use the device in the environment with flammable anesthetic gas.
2 The device should be used by trained and qualified medical personnel authorized by
EDAN.
3 Nitrous oxide, elevated levels of oxygen, helium, xenon, halogenated hydrocarbons,
and barometric pressure can influence the CO2 measurement.
4 The monitor will be damaged if any pipeline from the CO2 module is disconnected, or
the air tube /the air inlet /the air outlet are plugged by water or other materials.
5 The accuracy of the CO2 measurement will be affected by the following reasons: the
airway was highly obstructed; the leakage of air way connection or quick variation of
environment temperature.
6 Follow precautions for electrostatic discharge (ESD) and electromagnetic interference
(EMI) to and from other equipment.
7 In the presence of electromagnetic devices (i.e., electrocautery), patient monitoring
may be interrupted due to electromagnetic interference. Electromagnetic fields up to
20V/m will not adversely affect module performance.
8 Do not place the sensor cables or tubing in any manner that may cause entanglement
or strangulation.
9 Do not store the CO2 Module at temperatures less than -40º F (-40º C) or greater than
158º F (70º C). Do not operate the CO2 Module at temperatures less than 32ºF (0º C)
or greater than 104º F (40º C).
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NOTE:
After the low battery alarm appears, please do not start the CO2 measurement, or the
monitor may turn off for the low battery.
16.3 Monitoring Procedures

16.3.1 Zeroing the sensor
You must perform zeroing following the steps when using the new airway adapter.
1. Expose the sensor to room air and keep it away from all sources of CO2 including the
ventilator, the patient’s breath and the operator’s.
2. In the CO2 Setup menu, please set the Work Mode to Measure.
3. For EDAN module, select User Maintain > CO2 Maintain, and click Zero. For
Respironics modules, click Zero in the CO2 Setup menu.
4. If the system briefly displays Zero In Progress, the process is successful. After the
zeroing calibration is finished, you can start CO2 Monitoring. If the system displays
Breath detected or Zero required, zeroing has failed. Zero calibration must be
performed again.
16.3.2 Sidestream CO2 Module

16.3.2.1 Measurement Steps
EDAN Module
1 Appropriately connect the cannula, airway adapter or sample line to the sensor.
2 Set Work Mode to Measure.
3 For intubated patients, an airway adapter is required. For non-intubated patients, place the
nasal cannula onto the patient.
NOTE:
Disconnect the water trap from the holder or set Work Mode to Standby when the
module is not in use.
Respironics Sidestream Module

1 Plug the sensor cable into the monitor’s CO2 input connector. Allow the sensor two minutes
for warm-up.
2 Appropriately connect the cannula, airway adapter or sample line to the sensor. It will click
into place when seated correctly.
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Connecting Respironics Sidestream Module

3 To zero the sensor, please refer to zeroing the sensor.
4 For intubated patients, an airway adapter is required;
Air adapter
For non-intubated patients: Place the nasal cannula onto the patient.
Place the nasal cannula

NOTE:
1 You must perform a zero calibration as described in this procedure each time the
ambient temperature changes more than 10°C (for example during transport).
- 105 -
2 Always connect the airway adapter to the sensor before inserting the airway adapter
into the breathing circuit. In reverse, always remove the airway adapter from the
breathing circuit before removing the sensor.
3 Always disconnect the cannula, airway adapter or sample line from the sensor when
the sensor is not in use.
16.3.2.2 Removing Exhaust Gases from the System

WARNING
Anesthetics: When using the sidestream CO2 measurement on patients who are
receiving or have recently received anesthetics, connect the outlet to a scavenging
system, to avoid exposing medical staff to anesthetics.
Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the sidestream
sensor at the outlet connector.
16.3.3 Mainstream CO2 Module

NOTE:
You must perform a zero calibration as described in this procedure each time you use a
new airway adapter.
Respironics Mainstream CO2 Module
16.3.3.1 Measurement Steps

1 Attach the sensor connector to the CO2 connector on the monitor.
2 Wait two minutes, allowing the sensor to reach its operating temperature and a stable
thermal condition.
3 Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter
clicks into place when seated correctly.
- 106 -
Connecting Sensor
4 To zero the sensor, please refer to zeroing the sensor.
5 Install the airway adapter at the proximal end of the circuit between the elbow and the
ventilator Y-section.
Connecting Airway Adapter
WARNING
1 No routine user calibration required.
2 Accuracy is affected by temperature and barometric pressure.
3 It is forbidden to insert or draw out the module when the monitor is working, for it can
cause instability of the system. If you do it inadvertently, please turn off the module in
menu immediately. The module enters STANDBY mode if you reconnect it to monitor
which it is powered on. If the readings are inaccurate, you should do calibration.
- 107 -
NOTE:
1 Replace the airway adapter, if excessive moisture or secretions are observed in the
tubing or if the CO2 waveform changes unexpectedly without a change in patient
status.
2 To avoid infection, use only sterilized, disinfected or disposable airway adapters.
3 Inspect the airway adapters prior to use. Do not use it if airway adapter appears
damaged or broken. Observe airway adapter color coding for patient population.
4 Periodically check the flow sensor and tubing for excessive moisture or secretion
buildup.
16.3.3.2 Removing Exhaust Gases from the System

WARNING
Anesthetics: when using the mainstream CO2 measurement on patients who are
receiving or have recently received anesthetics, connect the outlet to a scavenging
system, to avoid exposing medical staff to anesthetics.
Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the
mainstream sensor at the outlet connector.
16.4 Setting CO2 Waveform Setup

Select the CO2 waveform area to open the CO2 waveform menu:
z Set Mode to Curve or Filled as your desire.
z Set Sweep to an appropriate value from the pop-up list. The bigger the value is, the quicker
the speed is.
16.5 Setting CO2 Corrections

Temperature, water vapor in the patient’s breath, barometric pressure, and the proportions of O2,
N2O and Helium in the mixture all influence CO2 absorption. If values seem inaccurately high or
low, check that the monitor is using the appropriate corrections.
For EDAN module, the following items are available in the CO2G Other Setup menu: N2O
Compen., O2 Compens., Anest. Agent, Vapor Compen. and Pump Rate.
For Respironics module, there are Baro Press, O2 Compens, Anes Agent and Balance Gas in
the CO2GOther Setup menu.
- 108 -
16.6 Changing CO2 Alarms

This refers to CO2 specific alarms. See the Alarms section for general alarm information. To
change the alarm, please refer to the following steps:
1. Select the CO2 Setup menu;
2. Select EtCO2 Alarm Setup, FiCO2 Alarm Setup or AwRR Alarm Setup to adjust the
alarm limit. About how to adjust the alarm limit, please refer to section Setting alarm limits.
16.7 Changing the Apnea Alarm Delay

This determines the time limit after which the monitor gives an alarm if the patient stops
breathing.
1. Select the CO2 Setup menu to open it;
2. Select Apnea Alm from the menu;
3. Choose the apnea alarm time from the pop-up list.
WARNING
Safety and effectiveness of the respiration measurement method in the detection of
apnea, particularly the apnea of prematurity and apnea of infancy, has not been
established.
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Patient Monitor User Manual Monitoring C.O.
Chapter 17 Monitoring C.O.
17.1 Overview
The Cardiac Output (C.O.) measurement is performed by using thermodilution method. The
monitor can determine blood temperature, measure cardiac output. You can have iced injecta
using either the flow through system or individual syringes of injecta. You can perform up to 6
measurements before editing the average Cardiac Output. The prompt message on the screen will
tell you when to inject.
17.2 C.O. Safety Information

WARNING
1 Make sure that appurtenance applied is in conformity with relevant Medical Device
Safety Requirements.
2 Appurtenance should be avoided from contact with conductive metal body when
being connected or applied.
NOTE:
To replace the catheter thermistor, please enter the catheter computation coefficient into
the Constant item according to the instruction.
17.3 C.O. Monitoring Procedures

1. Plug the C.O. interface cable into the C.O. socket and turn on the monitor.
2. Attach the injective probe connector and catheter thermistor connector to the appropriate parts
of the cardiac output interface cable. And open the patient information window to confirm the
patients’ height and weight.
3. Pick the C.O. Measure item in the C.O. Option menu.
4. You can perform more than one measurement as required.
5. After the completion of the measurement, access the C.O. Measure window for Review to
edit the measured data.
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1: Monitor; 2: Thermodilution Catheter; 3: Cardiac Output Cable; 4: Injectate Sensor Housing; 5:

Injectate; 6: Delivery System; 7: In-line injectate Temperature probe.
C.O. Sensor Connection
WARNING
Make sure that the computational constant for the measurement is appropriate to the
catheter used.
NOTE:
The blood temperature alarm will not function during C.O. measurement. It will resume
automatically when the measurement is over.
17.4 C.O. Measurement Window

Select the C.O. Option menu to enter the C.O. Measure window and start C.O. measurement. If
C.O. transducer is not connected, the monitor will display No Sensor on the screen.
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Ĺ
ĺ
Ļ
ļ
ķ Ľ
ľ

ĸ
C.O. Measure Window

ķ Measurement curve
ĸ Prompt message area
Ĺ Cardiac Output
ĺ Cardiac Index
Ļ Body Surface Area
ļ Blood Temperature
Ľ Injectate Temperature
ľ Start time of the measurement
Ŀ Function keys
The functional keys on the C.O. measure window are explained in the following table:
Start Start a measurement
Stop If the blood temperature cannot resume in a considerably
long time, the measurement could not stop automatically.
Use this button to stop the measurement and display the
C.O., CI calculation result.
Cancel Cancel the processing measurement or cancel the result
after measurement.
Record Print out the curve.
- 112 -
Y axis Change the scale Y (temperature) value. Three models are

available: 0~0.5qC, 0~1qC, 0~2.0qC. Adjust the scale by
the temperature differences. A smaller scale results in a
larger curve.
X axis Change the Scale X (time) value. Two modes are available:
0~30s, 0~60s. If you start measurement in the 0~30s mode,
it will be switched to 0~60s mode automatically if the
measurement cannot finish within 30 seconds. After the
switch, no further adjustment can be made to the Scale X.
Review Enter the Review window
Exit Press the item to exit C.O. Measure.
17.5 Measurement Process

Measurement should be taken when the message “Ready for new measurement” appears on the
screen. Press the Start button, and then start injection. The thermodilution curve, current blood
temperature and the injective temperature are displayed during the measurement. Curve drawing
will stop automatically when the measurement finishes, and the C.O. and CI (Ĺand ĺ in the
above figure) will be calculated and displayed on the screen. The monitor will display C.O. in the
parameter area and the start measurement time (ľ in the above figure).
To ensure the accuracy of the measurement, it is suggested that a reasonable interval should take
place between two consecutive measurements. The length of the interval can be set in the C.O.
Setup menu (Time unit: second). The interval time counter is displayed on the screen. The next
measurement cannot be performed until the time reduces to zero and a message Ready for new
measurement appears.
NOTE:
1 It is strongly recommended that the user must push the injector within four seconds
after pressing the Start button.
2 It is strongly recommended that you wait at least 1 minute (or longer depending on the
patient’s clinical condition) before starting the next measurement.
Repeat this procedure until you have completed the measurements you want.
You can perform a maximum of six measurement editing. If you perform additional
measurements the earliest measurement each time will be deleted. If any of the curves in the
editing window is not selected for calculation (excluded from the averaging calculations), the
place will be taken by the new measurement.
- 113 -
17.6 Editing C.O.

Pick the Review button on the C.O. Measure menu to access the Review as shown below:
ĸ Ĺ
Window For C.O. Edit

Contents displayed in the window:
ķ Six curves of the six measurements and C.O. value
ĸ Average value of C.O.
Ĺ Average value of CI
Values of selected measurements can be averaged and stored in the C.O. item in the HEMOD
menu as the basis for Hemodynamic calculations.
17.7 Blood Temperature Monitoring

Blood temperature monitoring can function when C.O. measurement is not taken. The blood
temperature is measured by the thermistor situated in the distal end of the flotation catheter in the
pulmonary artery.
The blood temperature alarm function will not work during the C.O. measurement. When the
measurement ends, the function will automatically resume.
The current blood temperature is displayed in the C.O. parameter area.
- 114 -
Right ventricle
Thermodilution Catheter Site
17.8 Setting the Computation Constant

The computation constant is associated with catheter and injective volume. When the catheter is
changed, please adjust Constant in the C.O. Settings menu based on product description
provided by the manufacturer.
17.9 Recording C.O. Measurements

C.O. measurement can be recorded by the recorder. To record the C.O. measurement, please
select Record in the C.O. Measure menu.
17.10 Setting INJ. TEMP Source

To change the INJ Temp Source, please:
1 Select Inj Temp Source in the C.O. Settings menu;
2 Select Auto or Manual from the list;
z Manual: directly displaying the injective temperature from INJ. TEMP.
z Auto: indicating the system obtains the injective temperature through sampling.
- 115 -
Patient Monitor User Manual Monitoring AG
Chapter 18 Monitoring AG
18.1 Overview
The monitor uses ISA sidestreasm gas analyzer (hereinafter called ISA analyzer) and IRMA
mainstream module (hereinafter called IRMA module) to monitor the anesthetic gas which can be
used to measure the gases of adult, pediatric and neonatal patients during anesthesia, recovery
and respiratory care. And the anesthetic gas includes Halothane (HAL), Isoflurane (ISO),
Enflurane (ENF), Sevoflurane (SEV), Desflurane (DES), CO2 and N2O.
18.2 Safety Information

18.2.1 Safety Information for ISA Analyzer
WARNING
1 The ISA analyzer is intended for use by authorized and trained medical personnel
only.
2 Use only Nomoline sampling lines manufactured by PHASEIN.
3 The ISA analyzer must not be used with flammable anesthetic agents.
4 Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
5 Do not re-use disposable sampling line.
6 Do not lift the monitor by the sampling line as it could disconnect from the monitor,
causing the monitor to fall on the patient.
7 Used disposable sampling lines shall be disposed of in accordance with local
regulations for medical waste.
8 Do not use adult/pediatric type sampling line configurations with infants, as this may
add dead space to the patient circuit.
9 Do not use infant type sampling line configurations with adults, as this may cause
excessive flow resistance.
10 Do not use the ISA analyzer with metered-dose inhalers or nebulized medications as
this may clog the bacteria filter.
11 Check that the gas sample flow is not too high for the present patient category.
12 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2)
in the gas analyzer, ensure that the ISA is placed in a well ventilated place. Avoid
breathing near the ISA side stream gas analyzer before or during the zeroing
procedure.
- 116 -
WARNING
13 The Nomoline sampling line and its interfaces are non-sterile devices. To avoid
damage, do not autoclave any part of the sampling line.
14 Never sterilize or immerse the ISA analyzer in liquid.
15 Measurements can be affected by mobile and RF communications equipment. Make
sure that the ISA analyzer is used in the electromagnetic environment specified in this
manual.
16 ISA analyzer is intended only as an adjunct in patient assessment. It must be used in
conjunction with other assessments of clinical signs and symptoms.
17 Replace the sampling line if the sampling line input connector starts flashing red, or a
Nomoline occlusion message is displayed on the host.
18 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.
19 ISA analyzers are not designed for MRI environments.
20 During MRI scanning, the monitor must be placed outside the MRI suite.
21 Use of high frequency electrosurgical equipment in the vicinity of the monitor may
produce interference and cause incorrect measurements.
22 Do not use external ambient cooling of the ISA device.
23 Do not apply negative pressure to the Nomoline to remove condensed water.
24 Too strong positive or negative pressure in the patient circuit might affect the sample
flow.
25 Exhaust gases should be returned to the patient circuit or a scavenging system.
26 Always use a bacteria filter on the evac side if sampled gas is intended to be
re-breathed.
27 Do not place the ISA analyzer in any position that might cause it to fall on the patient.
CAUTION
1 The ISA analyzers should be securely mounted in order to avoid the risk of damage to
the ISA.
2 Do not apply tension to the ISA analyzer cable.
3 Do not operate the ISA analyzer outside the specified operating temperature
environment.
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18.2.2 Safety Information for IRMA Module

WARNING
1 The IRMA probe is intended for use by authorized and trained medical personnel
only.
2 The IRMA probe must not be used with flammable anesthetic agents.
3 Disposable IRMA airway adapters shall not be reused. Used disposable airway
adapters shall be disposed of in accordance with local regulations for medical wastes.
4 Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors
shall be disposed of in accordance with local regulations for batteries.
5 Do not use the IRMA Adult/Pediatric adapter with infants as the adapter adds 6 ml
dead space to the patient circuit.
6 Do not use the IRMA airway adapter with adults as this may cause excessive flow
resistance.
7 Measurements can be affected by mobile and RF communications equipment. It
should be assured that the IRMA probe is used in the electromagnetic environment
specified in this manual.
8 Do not place the IRMA airway adapter between the endotracheal tube and an elbow
as this may allow patient secretions to block the adapter windows and result in
incorrect operation.
9 To keep secretions and moisture from pooling on the windows or oxygen sensor port,
always position the IRMA probe in a vertical position with the LED pointing upwards.
- 118 -
WARNING
10 Do not use the IRMA airway adapter with metered dose inhalsers or nebulized
medications as this may affect the light transmission of the airway adapter windows.
11 Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable
product and contains a caustic electrolyte and lead.
12 The IRMA probe is intended only as an adjunct in patient assessment. It must be used
in conjunction with other assessment of clinical signs and symptoms.
13 Incorrect probe zeroing will result in false gas readings.
14 Incorrect agent selection by the user for IRMA AX (no automatic agent identification)
will result in false agent readings.
15 Using IRMA AX (no automatic identification) with gas mixtures containing more than
one agent will result in false agent readings.
16 Replace the adapter if rainout/condensation occurs inside the airway adapter.
17 Use only PHASEIN manufactured IRMA airway adapters.
CAUTION
1 Do not apply tension to the probe cable.
2 Do not operate the IRMA probe outside the specified operating temperature
environment.
3 Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe
is not in use.
18.3 Monitoring Steps

18.3.1 Monitoring Steps for ISA Analyzer
18.3.1.1 Performing a Pre-use Check
Before connecting the Nomoline sampling line to the breathing circuit, do the following:
1. Connect the sampling line to the ISA gas inlet connector (LEGI).
2. Check that the LEGI shows a steady green light (indicating that the system is OK).
3. For ISA OR+ and ISA AX+ module with O2 option fitted: Check that the O2 reading on the
monitor is correct (21%).
4. Breathe into the sampling line and check that valid CO2 waveforms and values are displayed
on the monitor.
5. Occlude the sampling line with a fingertip and wait for 10 seconds.
6. Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light.
- 119 -
7. If applicable: Perform a tightness check of the patient circuit with the sampling line attached.
18.3.1.2 System Setup for Analyzer

If your system is using the plug-in and measure ISA analyzer, please follow the setup instructions
below:
1. Connect the ISA analyzer interface cable to the monitor.
2. Connect a Nomoline sampling line to the ISA analyzer input connector.
3. Connect the gas sample exhaust port to a scavenging system or return the gas to the patient
circuit.
4. Power up the monitor.
5. A green LED indicates that the ISA analyzer is ready for use.
6. Perform a pre-use check as described in section Perform a pre-use Check.
18.3.1.3 Zeroing
The infrared module needs to establish a zero reference level for the CO2, N2O and anesthetic
agent gas measurement. This zero calibration is here referred to as "zeroing".
ISA analyzer performs zeroing automatically by switching the gas sampling from the respiratory
circuit to ambient air. The automatic zeroing is performed every 24 hours, and takes less than 3
seconds for ISA CO2 module and less than 10 seconds for ISA analyzer.
If the ISA analyzer is fitted with an oxygen sensor, the automatic zeroing will also include room
air calibration of the oxygen sensor.
WARNING
1 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2)
in the ISA analyzer, ensure that the ISA analyzer is placed in a well ventilated place.
Avoid breathing near the ISA analyzer before or during the zeroing procedure.
2 The sampling line should be replaced every two weeks, otherwise it is clogged.
18.3.1.4 Maintenance
GAS readings should be verified by conducting the recommended maintenance checks. For
details, please refer to Chapter Maintenance.
WARNING
1. The Nomoline sampling lines are non-sterile devices. To avoid damage, do not
autoclave any parts of the sampling line.
2. Never sterilize or immerse the ISA analyzer in liquid.
- 120 -
18.3.1.5 MAC Calculation

The MAC value may be calculated and displayed by using end-tidal (Et) gas concentrations
according to the following formula:
% Et ( AA1) % Et ( AA2) % Et ( N 2O)
MAC + +
X ( AA1) X ( AA2) 100
X (AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%
NOTE:
Altitude, patient age and other individual factors are not considered in the formula above.
18.3.2 Monitoring Steps for IRMA Module

1 Plug the IRMA connector into the IRMA input and switch the power on.
2 Snap the IRMA sensor head on the top of the IRMA airway adapter. It will click into place
when properly seated.
3 A green LED indicates that the IRMA probe is ready for use.
4 Connect IRMA/airway adapter 15mm male connector to the breathing circuit Y-piece.
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5 Connect the IRMA/airway adapter 15mm female connector to the patient’s endotracheal
tube.
Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s endotracheal
tube and the IPMA probe. Placing an HME in front of the IRMA probe protects the airway
adapter from secretions and effects of water vapor and eliminates the need of changing the
adapter. It allows free positioning of the IRMA probe as well.
6 Unless the IRMA probe is protected with an HME always position the IRMA probe with the
status LED pointing upwards.
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18.3.2.1 Placement of IRMA Probe

When connecting IRMA probe to an infant patient circuit, it is important to avoid a direct contact
between the IRMA probe and the infant’s body. If, for whatever the reason, the IRMA probe is in
direct contact with any parts of the infant’s body, an insulation material shall be placed between
the IRMA probe and the body.
WARNING
The IRMA probe is not intended to be in long term skin contact.
18.3.2.2 Performing a Pre-use Check

Prior to connecting the IRMA airway adapter to the breathing circuit, verify the O2 calibration by
checking that the O2 reading on the monitor is correct (21%). See the following section on how to
perform air calibration.
Always verify gas readings and waveforms on the monitor before connecting the airway adapter
to the patient circuit.
Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA
airway adapter.
18.3.2.3 Zeroing
WARNING
Incorrect probe zeroing will result in false gas readings.
In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe, without
connecting the airway adapter to the patient circuit, and then using the host instrument to transmit
a zero reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during the
zeroing procedure. The presence of ambient air (21% O2 and 0% CO2) in the IRMA airway
adapter is of crucial importance for a successful zeroing. If a “ZERO-REQ” alarm should appear
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directly after a zeroing procedure, the procedure has to be repeated.

Always perform a pre-use check after zeroing the probe.
Zeroing for IRMA CO2 probes:
Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an
unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probe after power on and after changing the
IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED on the
probe will be blinking for approximately 5 seconds while zeroing is in progress.
Zeroing for IRMA AX+ probes:
Zeroing should be performed every time the IRMA airway adapter is replaced, or whenever an
offset in gas values or an unspecified gas accuracy message is displayed.
Allow 30 seconds for warm up of the IRMA AX+ probes after power on and after changing the
IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED on the
probe will be blinking for approximately 5 seconds while zeroing is in progress.
18.3.2.4 Cleaning
The IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or
maximum 70% isopropyl alcohol.
Remove the disposable IRMA airway adapter prior to cleaning the IRMA probe.
CAUTION
1 The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do
not autoclave the devices as this will damage them.
2 Never sterilize or immerse the IRMA probe in liquid.
18.3.2.5 MAC Calculation

The MAC value may be calculated and displayed by using end-tidal (ET) gas concentrations
according to the following formula:
MAC=%ET(AA1)/X(AA1)+%ET(AA2)/X(AA2)+%ET(N2O)/100
X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%
18.4 Setting Work Mode

There are two woke modes: Measure and Standby. To change the work mode, please refer to the
following steps:
1 Select the AG Setup menu;
2 Select Work Mode on the interface and select Measure or Standby from the popup list.
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18.5 Setting Alarms

Here we take CO2 alarm for example. This refers to CO2 specific alarms. See the Alarms Chapter
for general alarm information. To change the alarm, please refer to the following steps:
1 Select the CO2 Setup menu;
2 Select EtCO2 Alarm High Limit or EtCO2 Alarm Low Limit to adjust the alarm limit.
18.6 Setting Apnea Alarm Time

This determines the time limit after which the monitor gives an alarm if the patient stops
breathing.
1 Select the AG Setup menu to open it;
2 Select Apnea Alarm from the menu;
3 Choose the apnea alarm time from the pop-up list.
18.7 Working Status of ISA analyzer

Working status of the ISA analyzer can be indicated by the indicator. For the detailed information,
please refer to the following table.
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line
18.8 Working Status of IRMA Module

The working status of the IRMA module can be transmitted by the IRMA probe. For the detailed
information, please refer to the following table.
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adapter
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18.9 N2O and O2 Compensations

The following models need O2 compensation: IRMA AX+, IRMA CO2, ISA AX+, ISA CO2. The
following models need N2O compensation: IRMA CO2 and ISA CO2. For the compensation
details, please refer to the following table.
O2 Range SetO2 Range
0~30 vol% 21
30~70 vol% 50
70~100 vol% 85
N2O Range Set N2O Range

0~30 vol% 0
30~70 vol% 50
18.10 Effects of humidity

The partial pressure and the volume percentage of CO2, N2O, O2 and anesthetic agents depend on
the amount of water vapor in the measured gas. The O2 measurement will be calibrated to show
20.8 vol% at actual ambient temperature and humidity level, instead of showing actual partial
pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in room air with 0.7 vol% H2O
concentration (at 1013 hPa this equals for example 25°C and 23% RH). The measurement of CO2,
N2O, and anesthetic agents (e.g. all gases measured by the IR-bench) will always show the actual
partial pressure at the current humidity level.
In the alveoli of the patient, the breathing gas is saturated with water vapor at body temperature
(BTPS).
When the breathing gas flows through the sampling line, the gas temperature will adapt to
ambient before reaching the gas analyzer. As the NOMO section removes all condensed water, no
water will reach the ISA gas analyzer. The relative humidity of the sampled gas will be about
95%.
If CO2 values at BTPS are required, the following equation can be used:
where:
EtCO2 = EtCO2 value sent from ISA [vol %]
Pamb = Ambient pressure sent from ISA [kPa]
3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa]
EtCO2(BTPS) = EtCO2 gas concentration at BTPS [vol%]
O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O.
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Patient Monitor User Manual Freeze
Chapter 19 Freeze
19.1 Overview
When monitoring a patient, the user may freeze the waveforms and examine them. Generally, the
user can review a frozen waveform of a maximum of 120 seconds. The freeze function of this
monitor has the following features:
Freeze status can be activated on any operating screen.
Once entering the Freeze status, the system exits all other operating menus. Besides, the
system freezes all waveforms in the Waveform area of the Basic Screen, and also freezes
Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface (if any).
Nevertheless the Parameter area refreshes normally.
The frozen waveforms can be reviewed and recorded.
19.2 Entering/Exiting Freeze Status

19.2.1 Entering Freeze Status
In the Non-Freeze status, press the button on the control panel of the monitor to exit the
current menu. Freeze status is entered and the popup Freeze menu is displayed. In Freeze status,
all waveforms are frozen and will no longer be refreshed.
19.2.2 Exiting Freeze Status

In the Freeze status, executing any of the following operations will command the system to exit
the Freeze status:
z Select the Exit option in/from the Freeze menu;
z Press the button on the control panel again;

z Execute any operation that may trigger the adjustment of the screen or the display of a new
menu.
After exiting Freeze status, the system will clear screen waveforms and resume displaying
real-time waveforms. In the Screen Refresh mode, the system will sweep the waveforms from left
to right in the Waveform Area.
Press the button on the control panel, and the Freeze menu will appear on the bottom part
of the screen. At the same time, the system freezes the waveforms.
REC WAVE: it can be set to any waveform of 8s, such as IBP1, CO2, and PLETH etc. It
can also be set to OFF.
Review: Used to review frozen waveforms.
Exit: The system closes the Freeze menu and exits the Freeze status.
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Patient Monitor User Manual Freeze
NOTE:
Pressing the button repeatedly over a short period of time may result in
discontinuous waveforms on the screen.
19.3 Reviewing Frozen Waveform

By moving the waveform, you may review a waveform of 120 seconds before it is frozen. For a
waveform of less than 60 seconds, the remaining part is displayed as a straight line. Use the
rotary snob on the control panel to move the cursor to the Review option in the Freeze menu.
Press the knob. By turning the knob left or right, frozen waveforms on the screen will move left
or right correspondingly. There is an arrow indicating upward on the right side of the last
waveform.
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Patient Monitor User Manual Review
Chapter 20 Review
The monitor provides 120-hour trend data of all parameters, storage of 1200 NIBP measurement
results and 60 alarm events. This chapter gives detailed instruction for review of all data.
20.1 Trend Graph Review

The latest 1-hour trend is displayed every 1 or 5 seconds.
The latest 120-hour trend is displayed every 1, 5 or 10 minutes.
To review Trend Graph, please press the Trend Graph key on the screen or select Menu >
Review > Trend Graph, then the trend graph interface is displayed.
In the trend graph, the y-axis stands for the measurement value and x-axis stands for the time.
20.1.1 Selecting Trend Graph of Specific Parameter

The monitor can review trend graph of different parameters. To change the existing trend graph,
please select Menu > Review > Trend Graph and select a required parameter name from the
popup list (as shown in red text in the above figure).
20.1.2 Adjusting Trend Scale

You can use Zoom on the trend graph review interface to adjust the trend scale. Once you adjust
the trend scale on the trend graph review interface, you also change the trend scale of the related
parameters for the screen trend displayed on the main screen.
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20.1.3 Setting Resolution

The monitor can support five kinds of resolutions. To set an appropriate resolution, please select
Menu > Review > Trend Graph and an interface is displayed. Choose Resolution on the
interface to open the list and select an appropriate resolution among 1 sec, 5 sec, 1 min, 5 min
and 10 min.
20.1.4 Scrolling Left and Right the Screen

All trend graphs can’t be displayed on the current screen due to the screen limitation. The user
can scroll left and right the screen manually to see measurement trends that do not fit in the
current view by selecting and pressing the symbol and displayed on the trend graph.
20.1.5 Switching to the Trend Table

The user can switch to the trend table interface on the Trend Graph interface. To do so, please
select Menu > Review > Trend Graph and select the Trend Table option from the popup
interface.
20.1.6 Record
The monitor can make a tabular trend recording of the data in the current trend graph window.
The report will use the current trend interval settings. For the detailed information about
recording the trend graph, please refer to Chapter Recording.
20.2 Trend Table Review

To review the trend table, please press the Trend Table key on the screen or select Menu >
Review > Trend Table, then the trend table is displayed.
NOTE:
The CO2 module and AG module cannot be measured at the same time, so their trend
graph cannot be displayed at the same time.
20.2.1 Setting Resolution

The monitor can support seven kinds of interval. To set an appropriate resolution, please select
Menu > Review > Trend Table and an interface is displayed. Choose Resolution on the
interface to open the list and select an appropriate interval among 1 sec, 5 sec, 1 min, 5 min, 10
min, 30 min and 60 min.
20.2.2 Scrolling the Screen

All trend tables can’t be displayed on the current screen due to the screen limitation. The user can
scroll left, right, up and down the screen manually to see measurement trend tables that do not fit
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in the current view by selecting and pressing the symbol , , and displayed on the
trend graph.
20.2.3 Switching to Trend Graph

The user can switch to the trend graph on the Trend Table interface. To do so, please select
Menu > Review > Trend Table and select the Trend Graph option from the popup interface.
20.2.4 Recording
The monitor can make a tabular trend recording of the data in the current trend graph window.
The report will use the current trend interval settings. For the detailed information about
recording the trend table, please refer to Chapter Recording.
20.3 NIBP Review

To review the NIBP measurement data, select the NIBP Review key on the screen or select
Menu > Review > NIBP Review, then the NIBP Review window is displayed.

All measurement data can’t be displayed on the current screen due to the screen limitation. The
user can scroll up and down the screen manually to see measurement data that doesn’t fit in the
current view by selecting and pressing the symbol and displayed on the NIBP Review
interface.
20.3.2 Recording
The monitor can record the measurement data in the NIBP review window. For the detailed
information about recording the NIBP review, please refer to Chapter Recording.
20.4 Alarm Review

The monitor can display up to 10 technical alarm events in the current screen.
To review the alarm event, select the Alarm Review key on the screen or select Menu > Review
> Alarm Review, then the Alarm Review Window is displayed.

All alarm events can’t be displayed on the current screen due to the screen limitation. The user
can scroll up and down the screen manually to see alarm events that don’t fit in the current view
by selecting and pressing the symbol and displayed on the Alarm Review interface.
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20.4.2 Selecting Alarm Event of Specific Parameter

The monitor can review alarm event of the specific parameters. To view the alarm event of the
specific parameter, please select Menu > Review > Alarm Event and choose Event Type to
select the required parameter name from the popup list.
20.4.3 Setting Time Index

The user can set end time of alarm review by selecting the Time Index option displayed on the
alarm review interface.
If the user selects Current Time on the popup interface, the alarm events occurring before the
current time are displayed on the alarm event review interface.
If the user selects User Define, he can define the review time by setting time box displayed on
the interface. The alarm events occurring before the User Define option are displayed on the
alarm event review interface.
20.5 Arr Review

Select ECG Setup > Arr Analysis> Arr Review or Menu > Review > Arr Review to open the
Arr review interface. The interface displays the latest arrhythmia events.

All arrhythmia events can’t be displayed on the current screen due to the screen limitation. The
user can scroll up and down the screen manually to see the other arrhythmia events that do not fit
in the current view by selecting and pressing the symbol and displayed on the
Arrhythmia Review interface.
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20.6 12-lead Diagnosis Review

Select Menu > Review > Analysis Review to open the 12-lead analysis review interface.

All analysis results or waveforms can’t be displayed on the current screen due to the screen
limitation. The user can scroll up and down the screen manually to see the analysis results or
waveforms that do not fit in the current view by selecting and pressing the symbol and
displayed on the 12-lead analysis review interface.
20.6.2 Deleting Diagnosis Results

The user can delete the analysis results displayed on the current screen by selecting Delete on the
interface.
20.6.3 Switching Between Waveforms and Results

The user can review the analysis waveforms on the analysis result interface by selecting the
Wave option and review the analysis results on the analysis waveform interface by selecting the
Results option.
20.6.4 Recording
The monitor can record the 12-lead diagnosis waveforms or results displayed on the current
screen. To do so, press Record on the interface. For the detailed information about recording the
diagnosis waveforms or results, please refer to Chapter Recording.
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Patient Monitor User Manual Calculation and Titration Table
Chapter 21 Calculation and Titration Table

The monitor provides calculation function and titration table. Calculations are patient data that
are not directly measured but calculated by the monitor.
The monitor can perform drug calculation and hemodynamic calculation.
NOTE:
The drug calculation function acts only as a calculator. The patient weights in Drug
Calculation menu and in Patient Information menu are independent of each other.
Therefore changing the Weight in Drug Calculation menu will not change the weight in
the Patient Information menu.
21.1 Drug Calculation

21.1.1 Calculation Procedures
The drug calculation window is displayed by selecting Menu > Common Function > Drug
Dose. Select the right pull-down box of the Drug option and select the required drug name
among the 15 drugs which are listed as follows. And the drug name of Drug A, Drug B, Drug C,
Drug D and Drug E can be defined by the user.
z Drug A, Drug B, Drug C, Drug D and Drug E
z AMINOPHYLLINE
z DOBUTAMINE
z DOPAMINE
z EPINEPHRINE
z HEPARIN
z ISUPREL
z LIDOCAINE
z NIPRIDE
z NITROGLYCERIN
z PITOCIN
The system generates values that can’t be treated the calculation results. The user must enter the
correct parameter value based on the doctor’s instruction.
z Enter the patient’s weight.
z Enter the correct parameter value.
z Confirm whether the calculation result is correct.
The following formulas are applied to dose calculation:
Concentrate= Amount / Volume
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INF Rate= DOSE / Concentrate

Duration= Amount / Dose
Dose= Rate × Concentrate
DRIP Rate= INF Rate / 60 × DROP Size
21.1.2 Calculation Unit

Each drug has the fixed unit or unit series to calculate. Among the same unit series, the unit
binary varies with the entered parameter value.
The calculation units of the drugs are listed as follows:
Drug Unit
DRUG A, DRUG B, DRUG C, AMINOPHYLLINE, g, mg, mcg
DOBUTAMINE, DOPAMINE, EPINEPHRINE, ISUPREL,
LIDOCAINE, NIPRIDE, NITROGLYCERIN
DRUG D, PITOCIN, HEPARIN Ku, mu, Unit
DRUG E mEq
When defining a drug, select Drug A, Drug B, Drug C, Drug D, and Drug E based on the unit
series.
NOTE:
1 The drug calculation is displayed as invalid value before the user edits the drug name
and patient weight, and the user can’t enter any value.
2 Drip Rate and Drop Size are invalid in the neonatal mode.
21.2 Titration Table

After completing the drug calculation, the user can open the Titration on the Drug Dose
interface.
The user can change the following items in the titration table:
z Basic
z Step
z Dose Type
The data in the trend table will vary with the changes above. And the user can perform the
following:
z Scroll up and down the screen by selecting and pressing the symbol and displayed
on the trend graph.
z Record the data displayed in the current window by selecting Record.
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21.3 Hemodynamic Calculation

21.3.1 Calculation Procedure
1. The hemodynamic calculation interface is displayed by selecting Menu > Common
Function > Hemodynamic.
2. The user must input parameter value manually on this interface.
3. Select Calculate to output parameter value.
4. Select Confirm or Cancel to exit this menu.
21.3.2 Input Parameters
Abbreviation English Full Name/Description

PAWP Pulmonary artery wedge pressure
HR Heart rate
AP MAP Mean Artery Pressure
LV_D Left Ventricular Diameter
PA MAP Pulmonary artery mean pressure
HT Height
WT Weight
21.3.3 Output Parameters
Abbreviation English Full Name/Description

BSA Body surface area
SV Stroke volume
SVI Stroke volume index
SVR Systemic vascular resistance
SVRI Systemic vascular resistance index
PVR Pulmonary vascular resistance
PVRI Pulmonary vascular resistance index
LCW Left cardiac work
LCWI Left cardiac work index
RCW Right cardiac work
RCWI Right cardiac work index
LVSW Left ventricular stroke work
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LVSWI Left ventricular stroke work index

RVSW Right ventricular stroke work
RVSWI Right ventricular stroke work index
EF Ejection fraction
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Patient Monitor User Manual Recording
Chapter 22 Recording
22.1 General Information

A thermal dot matrix recorder is used for the monitor and can support many recording types and
output patient information, measurement data, review data waveform and so forth.
1 2
1 Recording indicator
2 Paper feeding key: press this key to start or stop feeding
recording paper without outputting anything on the paper
3 Paper outlet
4 Recorder door
22.2 Performance of the Recorder

Waveform record is printed at the rate of 25 mm/s or 50 mm/s.
48mm wide printout paper.
It can record up to three waveforms.
User-selectable real-time recording time and waveform.
Auto recording interval is set by the user, and the waveform is in accordance with the real
time recording.
NOTE:
It is suggested that the user should not use the recorder when the low battery displays, or
the monitor may be turned off automatically.
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22.3 Recording Type

The monitor provides several types of stripe recording:
Continuous real-time recording
8 seconds real-time recording
Time recording
Alarm recording
Trend graph recording
Trend table recording
NIBP review recording
Arrhythmia review recording
Alarm review recording
Titration recording
Hemodynamic Calculation result recording
12-lead analysis recording
C.O. measurement recording
22.4 Starting and Stopping Recording

You can start and stop the recording in the following ways:
Continuous real-time recording Press the Record button on the front panel to start the
recording, and repress it to stop the recording.
8 seconds real-time recording Record three waveforms selected in Recorder Setup menu
according to the setup time interval in Recorder Setup
menu. It will automatically stop in 8 seconds.
Trend graph recording Enter the Menu > Review > Trend Graph menu, and press
the Record button to start recording. Press the Record
button on the front panel to stop recording.
Trend table recording Enter the Menu > Review > Trend Table menu, and press
NIBP review recording Enter the Menu > Review > NIBP Review menu, then
press the Record button to start recording. Press the
Record button on the front panel to stop recording.
Arrhythmia review recording Enter the Menu > Review > ARR Review menu, and select
one arrhythmia alarm, then press the Record button to start
recording. Press the Record button on the front panel to
stop recording.
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Alarm review recording Enter the Menu > Review > Alarm Review menu, and
select one alarm, then press the Record button to start
stop recording.
Drug calculation titration Enter the Menu > Common Function > Drug Dose >
recording Titration menu, then press the Record button to start
stop recording.
Hemodynamic Calculation Enter the Menu > Common Function > Hemod Dynamics
result recording menu, then press the Record button to start recording. Press
the Record button on the front panel to stop recording.
12-lead diagnosis recording Enter the ECG Setup > 12-L Review menu, then press the
Record button to start recording. Press the Record button
on the front panel to stop recording.
C.O. measurement recording Enter the C.O. Option > C.O. Measure menu, then press
The recorder will stop recording in the following situations:

z The recording task is finished.
z No paper in the recorder.
z Malfunction stops the recorder from running properly.
NOTE:
You can press the button on the front panel to stop the currently recording process.
22.5 Recorder Operations and Status Messages
22.5.1 Record Paper Requirement

Only standard thermosensitive record paper can be used: otherwise the recorder may not function,
the recording quality may be poor, and the thermosensitive printhead may be damaged.
22.5.2 Proper Operation

When the recorder is working, the record paper goes out steadily. Do not pull the paper
outward with force: otherwise the recorder may be damaged.
Do not operate the recorder without record paper.
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22.5.3 Paper Out

When the Recorder Out OF Paper alarm is displayed, the recorder cannot start. Please insert
record paper properly.
22.5.4 Replacing Paper

1. Pull outwards the upper arc part of the recorder casing to release the casing, shown in the
following figure.
2. Insert a new roll of paper into the paper cassette, printing side facing upwards.
3. Ensure proper position and tidy margin.
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4. Pull about 2cm of the paper out, and close the recorder casing.
NOTE:
Be careful when inserting papers. Avoid damaging the thermo-sensitive print head.
Unless when inserting papers or shooting troubles, do not leave the recorder catch open.
22.5.5 Removing Paper Jam

When the recorder functions or sounds improperly, you should open the recorder casing to check
for a paper jam. Remove the paper jam in the following way:
Cut the record paper from the feeding edge.
Open the recorder casing.
Re-insert the paper.
NOTE:
If the monitor is not installed with a recorder, it will indicate RECORDER SETUP
NEEDED after pressing the Record button.
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Patient Monitor User Manual Other Functions
Chapter 23 Other Functions
23.1 Nurse Call

The monitor provides dedicated nurse call port which is connected to nurse call system through
the nurse call cable to perform the nurse call function. You should activate the function following
the steps below:
1. Select Maintenance > User Maintain, input the password ABC;
2. Select Other Setups> Aux Output;
3. Choose On in the Nurse Call list.
23.2 Analog Output and Defibrillator Synchronization

The monitor provides analog output signals to accessory equipment. Also, if a defibrillator is
connected to the monitor, a defibrillator synchronization pulse can be output. You should activate
the function following the steps below:
4. Select Maintenance > User Maintain, input the password ABC;
5. Select Other Setups> Aux Output;
6. Choose Analog Output or Defibrillation in the Aux Output list.
23.3 Storing Data in a Removable Device

23.3.1 Data Stored in the Removable Device
A single piece of patient data maximally contains the following information:
Patient information MRN, name, date of birth, date of admission, gender, type,
height, weight, blood type, pace, doctor, bed No., department
Trend graph and trend table a maximum of 10 days
NIBP measurement review 1200 sets
Alarm review 60 sets
Arrhythmia event 60 sets
12-lead diagnosis review 50 sets
Waveforms 48 hours
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23.3.2 Activating/ Deactivating Data Storing

To activate/ deactivate the data storing function, select Menu> Maintenance> User Maintain >
Other Setups, and set Data Store to On/ Off.
The monitor will stop storing data in the removable device under the following circumstances:
z The removable device is unplugged.
z There is no enough space in the removable device for storing data.
z The removable device is read-only.
z The data storing function is deactivated.
z The monitor is switched off.
z The power supply is off.
23.3.3 Selecting a Removable Device

You may plug several removable devices into the monitor at the same time, but only one is
operative. You can select a removable device as a working one among the plugging devices by
selecting Menu> Removable Device and choosing the device name from the list. By default, the
first plugged removable device is the working one.
CAUTION
1 Not all the removable devices are compatible with the monitor, Use the removable
devices recommended by EDAN.
2 Do not set the read-only switch on the removable device to on when the removable
device is inserted in the monitor.
23.3.4 Reviewing Data Stored in a Removable Device

To review data stored in a removable device, select Menu> Review> External Data, and choose
a patient from the list to review the data including patient information, trend graph, trend table,
NIBP measurements, arrhythmia event, alarm event, 12-lead diagnosis and waveform.
NOTE:
12-lead diagnosis review is only applicable to iM80.
23.3.5 Deleting Data Stored in a Removable Device

To delete data of one patient, choose the patient from the list after selecting Menu> Review>
External Data, and then click Delete Data on the Review menu. Further confirmation of
deletion is required.
To delete data of all patients, select Menu> Review> External Data and click Delete all data on
the External Data Review menu. Further confirmation is required.
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23.3.6 Ejecting a Removable Device

Before unplugging a removable device from the monitor, you need to select Menu> Removable
Device and click Eject to uninstall the removable device.
CAUTION
Do not remove the removable device without ejecting it during data storing, or the
removable device might be damaged.
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Patient Monitor User Manual Using Battery
Chapter 24 Using Battery
24.1 Battery Power Indicator

The indicator labeled Battery on the front panel of the monitor illuminates in green when the
monitor is battery powered and illuminates in yellow when battery is being charged. The
indicator is not illuminated when the monitor is not powered or when AC power is applied.
24.2 Battery Status on the Main Screen

Battery status shows the status of each battery detected and the combined battery power
remaining, with an estimate of the monitoring time this represents.
There is a sign in the lower left corner of screen to show the charging status, and the
yellow part is the electric energy of battery. When the monitor is not equipped with battery, the
battery status will be shown as the sign , which means no battery.

When the monitor is powered by the battery, the monitor will switch off automatically if there is
no electric energy in the battery. When there isn’t enough electric energy, a sign is
displayed on the screen.
When the monitor is battery powered, the monitor switches off automatically if there is no power.
24.3 Checking Battery Performance

The performance of rechargeable batteries may deteriorate over time. Battery maintenance as
recommended here can help to slow down this process.
1. Disconnect the patient from the monitor and stop all monitoring and measurement.
2. Switch the monitor power on and charge the battery for more than 6 hours continuously.
3. Disconnect monitor from mains power and let the monitor run until there is no battery power
left and the monitor shuts off.
4. The running time of the battery reflects the battery performance.
If the running time is obviously less than the specified time in the specification, please change the
battery or contact the service personnel.
WARNING
1 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure
to read the user manual and safety precautions thoroughly.
2 Do not connect the positive (+) and negative (-) terminals with metal objects, and do
not put the battery together with metal object, which can result in short circuit.
- 146 -
WARNING
3 Do not unplug the battery when monitoring.
4 Do not heat or throw battery into a fire.
5 Do not use, leave battery close to fire or other places where temperature may be
above 60qC.
6 Do not immerse, throw, or wet battery in water/seawater.
7 Do not destroy the battery: do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
8 Use the battery only in the monitor. Do not connect battery directly to an electric outlet
or cigarette lighter charger.
9 Do not solder the leading wire and the battery terminal directly.
10 If liquid leaking from the battery gets into your eyes, do not rub your eyes. Wash them
well with clean water and go to see a doctor immediately. If liquid leaks of the battery
splash onto your skin or clothes, wash well with fresh water immediately.
11 Keep away from fire immediately when leakage or foul odor is detected.
12 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
13 Do not use a battery with serious scar or deformation.
24.4 Replacing the Battery

To install or replace the battery, please follow the procedure:
Battery Door
1. Pull the battery door according to indication on it to open it.

2. Pull the plastic retainer until the battery can be removed.
- 147 -
3. Insert the new battery into the battery compartment.

4. Pull the metal retainer downward to fix the battery and close the battery door.
24.5 Recycling the Battery

When the battery no longer holds a charge, it should be replaced. Remove the old battery from
the monitor and recycle it properly.
NOTE:
To prolong the life of rechargeable battery, it is recommended to charge it at least once
every month, and it must be done after the electric energy runs out.
24.6 Maintaining the Battery

Batteries should be conditioned regularly to maintain their useful life.
Remove the batteries from the monitor if they are not used for a longer period of time. And
recharge the batteries at a minimum of every 6 months when they are stored.
Discharge the battery completely once every month.
- 148 -
Patient Monitor User Manual Care and Cleaning
Chapter 25 Care and Cleaning

Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect
your equipment. Warranty does not cover damage caused by using unapproved substances or
methods.
EDAN makes no claims regarding the efficacy of the listed chemicals or methods as a means for
controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist for
control infection.
25.1 General Points

Keep your monitor, cables and accessories free of dust and dirt. To prevent the device from
damage, please follow the procedure:
z Always dilute according to the manufacturer’s instructions or use lowest possible
concentration.
z Do not immerse any part of the equipment or any accessories in liquid.
z Do not pour liquid onto the system.
z Do not allow liquid to enter the case.
z Never use abrasive material (such as steel wool or silver polish).
CAUTION
If you spill liquid on the equipment, battery, or accessories, or they are accidentally
immersed in liquid, contact your service personnel or EDAN service engineer.
25.2 Cleaning
WARNING
Before cleaning the monitor or the sensor, make sure that the equipment is switched off
and disconnected from the power line.
25.2.1 Cleaning the Monitor

To surface-clean the monitor:
Recommended cleaning agents are:
Diluted Ammonia Water < 3%;
Ethanol 75%, isopropanol 70%
- 149 -
25.2.2 Cleaning the Accessories

25.2.2.1 Cleaning the ECG Cables and Lead Wires
NOTE:
1. Use only recommended cleaning substances and disinfectants listed in this document.
Others may cause damage (not covered by warranty), reduce product lifetime or
cause safety hazards.
2. Keep the cable and lead wires free of dust and dirt.
3. Never immerse or soak the ECG cable.
4. Inspect the cables after cleaning.
Ethanol 75%
Isopropanol 70%
25.2.2.2 Cleaning the Blood Pressure Cuff

If the cover requires more rigorous cleaning, remove the air bladder first. Allow the cover to
thoroughly air dry before use.
Cuffs have been tested to withstand the following recommended cleaning agents: isopropyl 70%,
ethanol 75%.
25.2.2.3 Cleaning the SpO2 Sensor

These reusable sensors should be cleaned and disinfected. The validated cleaning agents are listed
below:
Ethanol 75%
Isopropanol 70%
25.2.2.4 Cleaning the IBP/C.O. Cables

NOTE:
1. Keep the cable free of dust and dirt.
2. Never immerse or soak the cable.
3. Inspect the cables after cleaning.
Ethanol 75%
Isopropanol 70%
- 150 -
25.2.2.5 Cleaning TEMP/Quick TEMP Sensor

Ethanol 75%
Isopropanol 70%
25.2.2.6 Other Accessories

For cleaning, disinfecting other accessories, please contact the manufactures for details.
25.3 Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when stipulated
as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first.
Recommended types of disinfecting agents are:
Ethanol 75%, isopropanol 70%
Acetaldehyde up to 3.6%
WARNING
Disinfect the monitor and reusable accessories regularly to avoid patient cross infection.
- 151 -
Patient Monitor User Manual Maintenance
Chapter 26 Maintenance
WARNING
1 Failure on the part of the responsible individual hospital or institution employing the
use of this equipment to implement a satisfactory maintenance schedule may cause
undue equipment failure and possible health hazards.
2 If you discover a problem with any of the equipment, contact your service personnel,
or your authorized supplier.
26.1 Inspecting
The overall check of the monitor, including the safety check, should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
z If the environment condition and power supply meet requirement.
z If the power supply cord has damage and insulativity meets requirement.
z If the device and accessories have damage.
z Specified accessories.
z If the alarm system can work properly.
z If the recorder can work properly and the paper meets the requirement.
z Battery performance
z If all monitoring functions are in good conditions.
z If the grounding resistance and leakage current meet requirement.
If any damage or abnormality is found, please don’t use the monitor and contact local Customer
Service Center.
26.2 Maintenance Task and Test Schedule

The following tasks are for EDAN-qualified service professionals only. Contact an
EDAN-qualified service provider if your monitor needs a safety or performance test. Clean and
disinfect equipment to decontaminate it before testing or maintaining it.
Maintenance and Test Schedule Frequency
Safety checks. Selected tests on At least once every two years, or as needed, after any
the basis of IEC60601-1 repairs where the power supply is removed or replaced,
or if the monitor has been dropped.
Check ECG synchronization of the At least once every two years, or as needed.
monitor and defibrillator
- 152 -
Patient Monitor User Manual Maintenance
NIBP Leakage Inspection At least once every two years, or as specified by local
laws.
NIBP Pressure Calibration At least once every two years, or as specified by local
laws.
NIBP Calibration At least once every two years, or as specified by local
laws.
CO2 Calibration and Performance At least once every two years, or if you suspect the
Test measurement values are incorrect.
AG Calibration If you suspect the measurement values are incorrect and
need to calibrate, please contact the manufacturer.
- 153 -
Patient Monitor User Manual Warranty and Service
Chapter 27 Warranty and Service
27.1 Warranty
EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of:
a) damage caused by mishandling during shipping.
b) subsequent damage caused by improper use or maintenance.
c) damage caused by alteration or repair by anyone not authorized by EDAN.
d) damage caused by accidents.
e) replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials,
components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.
27.2 Contact information

If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.
Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
- 154 -
Patient Monitor User Manual Accessories
Chapter 28 Accessories
You can order accessories from EDAN supplies at www.edan.com.cn or consult your local
EDAN representative for details.
WARNING
1 Never reuse disposable transducers, sensors, accessories and so forth that are
intended for single use, or single patient use only. Reuse may compromise device
functionality and system performance and cause a potential hazard.
2 Use only EDAN-approved accessories. Using non-EDAN-approved accessories may
compromise device functionality and system performance and cause a potential
hazard.
3 Do not use a sterilized accessory if its packaging is damaged.
NOTE:
Transducers and sensors have a limited shelf life. Refer to the package labeling.
The following cables may not all be available in all countries. Please check availability with your
local EDAN supplier.
28.1 ECG Accessories

The following table lists the optional configuration for the monitor:
Part Number Accessories
01.57.471230 ECG trunk cable, 5-lead, 6pin, ESU, AHA/IEC, 2.7m, reusable
01.57.471231 ECG trunk cable, 5-lead, 6pin, ESU, AHA/IEC, 5.0m, reusable
01.57.471232 ECG trunk cable, 5-lead, 6pin, defibrillator-proof, AHA/IEC, 2.7m, reusable
01.57.471233 ECG trunk cable, 5-lead, 6pin, defibrillator-proof, AHA/IEC, 5.0m, reusable
01.13.036620 ECG limb wires, 5-lead, clip, AHA, 1.0m&1.6m, reusable
01.13.036621 ECG limb wires, 5-lead, clip, AHA, 1.0m, reusable
01.13.036622 ECG limb wires, 5-lead, snap, AHA, 1.0&1.6m, reusable
01.13.036623 ECG limb wires, 5-lead, snap, AHA, 1.0m, reusable
01.13.036624 ECG limb wires, 5-lead, clip, IEC, 1.0m&1.6m, reusable
01.13.036625 ECG limb wires, 5-lead, clip, IEC, 1.0m, reusable
01.13.036626 ECG limb wires, 5-lead, snap, IEC, 1.0&1.6m, reusable
- 155 -
01.13.036627 ECG limb wires, 5-lead, snap, IEC, 1.0m, reusable
01.57.471024 3-lead ECG trunk cable, Defibrillator-proof, AHA/IEC
01.57.471025 3-lead clip ECG limb wires, IEC
01.57.471165 3-lead ,clip, ECG limb cable, AHA
ECG trunk cable, 10-lead, defibrillator-proof, IEC, 2.6m, reusable (Only

01.57.040202
applicable to iM80)
01.57.040203 ECG limb wires, 10-lead, snap, IEC, 0.9m, reusable (Only applicable to iM80)
ECG trunk cable, 10-lead, defibrillator-proof, AHA, 2.6m, reusable (Only

01.57.109100
applicable to iM80)
ECG limb wires, 10-lead, snap, AHA, 0.9m, reusable (Only applicable to
01.57.109101
iM80)
01.57.471095 ECG Cable, 3 lead, snap, defibrillator-proof, AHA, 3.5m, reusable
01.57.471087 ECG Cable, 3 lead, clip, defibrillator-proof, AHA, 3.5m, reusable
01.57.471096 ECG Cable, 5 lead, snap, defibrillator-proof, AHA, 3.5m, reusable
01.57.471097 ECG Cable, 5 lead, clip, defibrillator-proof, AHA, 3.5m, reusable
01.57.471098 ECG Cable, 3 lead, snap, defibrillator-proof, IEC, 3.5m, reusable
01.57.471099 ECG Cable, 3 lead, clip, defibrillator-proof, IEC, 3.5m, reusable
01.57.471089 ECG Cable, 5 lead, snap, defibrillator-proof, IEC, 3.5m, reusable
01.57.471088 ECG Cable, 5 lead, clip, defibrillator-proof, IEC, 3.5m,reusable
01.57.471196 ECG limb cable, 3-lead, snap, AHA, 0.63m, DIN, reusable
01.57.471198 ECG limb cable, 3-lead, clip, AHA, 0.63m, DIN, reusable
01.57.471195 ECG limb cable, 3-lead, snap, IEC, 0.63m, DIN, reusable
01.57.471197 ECG limb cable, 3-lead, clip, IEC, 0.63m, DIN, reusable
ECG trunk cable, 3-lead, 6pin, defibrillator-proof, AHA/IEC, 2.9m, DIN,

01.57.471193
reusable
ECG conductive adhesive electrodes, TYCO KENKALL MEDI TRACE 210,

01.57.471276
10PCS/package
11.57.471056 Adult disposable adhesive electrodes, TYCO H99SG, 30PCS/package, CE
- 156 -
Adult disposable adhesive electrodes, TYCO Medi-Trace 200,

11.57.471060
100PCS/package, FDA
Children/Neonatal disposable adhesive electrodes, TYCO H124SG,

11.57.471057
50PCS/package, CE
28.2 SpO2 Accessories

For EDAN Module
EDAN SH1 Adult Reusable SpO2 Sensor (Lemo) (Only compatible with
02.01.210119
EDAN SpO2 module), 2.5 m (finger type, for patients more than 40kg)
EDAN SH1 Adult Reusable SpO2 Sensor (DB9) (Only compatible with
02.01.210120 EDAN SpO2 module and EDAN SpO2 Extension cable ), 1m (finger type, for
patients more than 40kg)
EDAN SH3 Neonate Warp SpO2 Sensor (DB9) (Only compatible with
12.01.110492 EDAN SpO2 module and EDAN SpO2 Extension cable),1m (hand or foot, for
patients less than 3kg)
EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (DB9) (Immersion

02.01.210122 Disinfection) (Only compatible with EDAN SpO2 module and EDAN SpO2
Extension cable), 1m (finger type, for patients more than 50kg)
EDAN SH5 pediatric Silicone Soft-tip SpO2 Sensor ( DB9) (Only compatible
02.01.210121 with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m (finger
type, for patients between 10kg to 50kg)
01.13.210001 EDAN SpO2 Extension cable(DB9 to Lemo, 2m, TPU)
EDAN Adult Single-Patient SpO2 sensor SHD-A (forefinger, for patients

01.57.471235
over 30kg)
EDAN Pediatrics Single-Patient SpO2 sensor SHD-P (forefinger, for patients

01.57.471236
between 10kg to 50kg)
EDAN Infant Single-Patient SpO2 sensor SHD-I (big toe, for patients
01.57.471237
between 3kg to 20kg)
EDAN Neonate Single-Patient SpO2 sensor SHD-N (foot, for patients less
01.57.471238
than 3kg)
- 157 -
For Nellcor Module
Nellcor Reusable Adult SpO2 Sensor (DS-100A OxiMax) (forefinger, for

11.15.30043
patient over 30kg)
Nellcor Reusable Adult/Neonate SpO2 Sensor (OXI-A/N OxiMax)

11.15.40096
(forefinger or foot)
Nellcor SpO2 Extension cable (Compatible with Nellcor OXI-Max SpO2

11.13.30131
module and Nellcor sensor)
28.3 NIBP Accessories

Part
Accessories
Number
For EDAN Module

01.57.471326 EDAN Reusable Blood Pressure Cuff Infant E5
01.57.471327 EDAN Reusable Blood Pressure Cuff Small Child E6
01.57.471328 EDAN Reusable Blood Pressure Cuff Child E7
01.57.471329 EDAN Reusable Blood Pressure Cuff Small Adult E8
01.57.471330 EDAN Reusable Blood Pressure Cuff Adult E9
01.57.471331 EDAN Reusable Blood Pressure Cuff Large Adult E10
01.57.471005 NIBP Tube (3m) with connector
01.57.40020 Infant blood pressure cuff (10-19cm)ˈCM1201
01.57.40018 Pediatrics blood pressure cuff (18-26cm)ˈCM1202
01.57.40029 Adult blood pressure cuff (25-35cm)ˈCM1203
01.57.40074 Lager adult blood pressure cuff (33-47cm)ˈCM1204
01.57.471323 NIBP Cuff, Neonate, 10cm-15cm, reusable
01.57.471324 NIBP Cuff, Neonate, 6cm-11cm, reusable
11.57.40097 Neonatal Cuff 5102 (About 6-9cm), for single patient use
11.57.40098 Neonatal Cuff 5104 (About 9-14cm), for single patient use
01.57.471157 NIBP Cuff, neonatal #1, 3-6cm, for single patient use
- 158 -
Part
Accessories
Number
01.57.471021 Connecting Tube for Neonatal Cuff (Only compatible with Neonatal
Disposable and NIBP Tube)
01.57.471303 NIBP spiral Tube with connector
01.57.471291 NIBP Tube (3m) with RECTUS quick connector
For Omron Module
01.59.102099 OMRON NIBP Tube (3.5m) /CUFF HOSE (NO.1) length3.5m, CE (Only
applicable to iM80 and iM70)
01.57.471078 OMRON CUFF/CUFF (NO.1) arm12—18cmˈwidth7cmˈLATEX, CE (Only




01.57.471081 OMRON Neonatal disposable cuff/CUFF (NO.10) arm3.5—6cm, width2.5cm,

CE (Only applicable to iM80 and iM70)
01.57.471082 OMRON Neonatal disposable cuff/CUFF (NO.11) arm5—7.5cmˈwidth3cm,

01.57.471083 OMRON Neonatal disposable cuff/CUFF (NO.12) arm7.5—10.5cm,

width4cm, CE (Only applicable to iM80 and iM70)
01.57.471084 OMRON Neonatal disposable cuff/CUFF (NO.13) arm8.5—13cm, width5cm,

Connecting Tube for Neonatal Cuff (Only compatible with Neonatal
01.59.473003 Disposable and NIBP Tube)/CUFF HOSE (NO.3) length3.5mˈCE (Only
- 159 -
28.4 Temp Accessories

01.15.040257 Neonatal/pediatric Skin Temperature Probe (2.252K)
01.15.040258 Neonatal/pediatric Intracavitary Temperature Probe (2.252K)
01.15.040259 Neonatal/pediatric Skin Temperature Probe (10K)
01.15.040260 Neonatal/pediatric Intracavitary Temperature Probe (10K)
01.15.040265 Skin Temperature Probe (2.252K)
01.15.040266 Intracavitary Temperature Probe (2.252K)
01.15.040267 Skin Temperature Probe (10K)
01.15.040268 Intracavitary Temperature Probe (10K)
28.5 Quick Temp Accessories*

02.04.110140 Oral/Auxiliary Probe

02.04.110139 Rectal Probe
11.57.110159 Probe Covers
* Only applicable to iM50

* Not available in the U.S.A., Canada, UK and Germany
28.6 IBP Accessories

6Pin ICP Transducer Interface cable (compatible with Gaeltec ICT/B

01.57.471280 Intracranial Pressure Transducer)
01.57.471014 Pressure transducer interface cable, BD
01.57.471013 Pressure transducer interface cable, EDWARD
01.57.471027 Pressure transducer interface cable, HOSPIRA
01.57.471028 Pressure transducer interface cable, UTAH
11.57.40121 Disposable pressure transducer kit (BD DTX TM Plus DT-4812 682000)
- 160 -
28.7 CO2 Accessories

For EDAN Module

Dewatering Cup(Single Patient Use, Adult/Pediatric 10ml) (Only applicable
02.01.210520
to iM80 and iM70)
CO2 Sampling Line with Male Luer Lock, 2.0m (Only applicable to iM80
01.57.471275
and iM70)
All Purpose Sampling Cannula without filter (Non Sterile). Size: Adult
01.57.471282
(Only applicable to iM80 and iM70)
All Purpose Sampling Cannula without filter (Non Sterile). Size: Infant (Only
01.57.471283
All Purpose Sampling Cannula without filter (Non Sterile). Size: Neonate
01.57.471284
(Only applicable to iM80 and iM70)
Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Adult (Only
01.57.471285
Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Child (Only
01.57.471286
Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Adult (Only
01.57.471287
Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Child (Only
01.57.471288
For Respironics Module
12.08.078137 Respironics EtCO2 module/(Side-stream) 1022054
11.15.040143 Respironics CAPNOSTAT 5 EtCO2 (Main-stream) Module 1015928
12.08.078166 LoFloTM Module Mounting Bracket(Respironics 1027730)
11.57.078139 Disposable CO2 Nasal Cannula - Adult (Respironics 3468ADU-00)
11.57.078151 Adult/Pediatric Airway adapter kit with dehumidification tubing
Disposable Sampling Line Kit with Dehumidification Tubing (Respironics
11.57.078154
3475-00)
11.57.471019 Reuseable Adult/Pediatric Airway Adapter (7007-01)
11.57.471020 Reuseable Neonate/Infant Airway Adapter (7053-01)
11.59.078155 Disposable Adult Airway Adapter (6063-00)
11.59.078156 Disposable Neonatal( infant/pediatric) Airway Adapter (6312-00)
11.57.078142 Adult Nasal CO2 with O2 delivery sampling cannula
- 161 -
11.57.078143 Pediatric Nasal CO2 with O2 delivery sampling cannula

11.57.078144 Infant Nasal CO2 with O2 delivery sampling cannula
11.57.101019 Adult Nasal/Oral CO2 sampling cannula
11.57.101020 Pediatric Nasal/Oral CO2 sampling cannula
11.57.101021 Adult Nasal/Oral CO2 with O2 delivery sampling cannula
01.12.031598 Adult/Pediatric Airway adapter kit
11.57.078140 Disposable CO2 Nasal Cannula - Pediatric (Respironics 3468PED-00)
11.57.078141 Disposable CO2 Nasal Cannula - Infant (Respironics 3468INF-00)
11.57.078152 Pediatric/Infant Airway adapter kit with dehumidification tubing
11.57.078158 Pediatric mask/mainstream 9960PED-00
11.57.078159 Adult standard mask /mainstream 9960STD-00
11.57.078160 Adult large mask /mainstream 9960STD-00
11.57.078161 Band/mainstream 8751-00
11.12.078162 bayonet socket
28.8 C.O. Accessories*

01.57.471012 Cardiac output cable

11.13.40119 In-line Injection temperature probe (BD 684056-SP4042)
11.57.40120 In-line Injection temperature probe housing (BD 680006-SP5045)
11.57.100175 Control Syringe (Medex MA387)
*Not applicable to iM50
28.9 AG Accessories*
11.57.471043 Nomoline with Luer Lock connector, Box of 25CAT.NO. 108210

11.57.471042 IRMA Airway AdapterAdult/Pediatric, Box of 25CAT.NO. 106220
Nomoline Adapter, Cat no: 108220, Sampling line with female luer lock
01.57.471189
connector.Adult/Pediatric/Infant, 0.15 m
- 162 -
Nomoline Airway Adapter Set, Cat no: 108230, Sampling line with
01.57.471190
straight airway adapter, single-patient use, Adult/Pediatric, 2.0 m
Nomo Extension, Cat no: 108240, Sampling line with male luer lock
01.57.471191
connector, 2.0 m
T-adapter, Cat no: 108250, Airway adapter with female luer lock
01.57.471192
connector, Adult/Pediatric
* Only applicable to iM70 and iM80
28.10 Other Accessories

11.57.471048 Assembly board for iM80 gas module

11.21.064143 Rechargeable Lithium-Ion Battery, 14.8V, 4.2Ah
02.01.210217 EPRT-48mm recorder, Serial/parallel port
12.01.19084 Thermal printer
02.01.109592 Pole clamp, 1 set /package
02.01.109636 Pole clamp, 4 sets/package
01.57.78035 Recorder paper
11.21.64056 Vehicle-carried Inverter
01.18.052268 Netac USB Flash Drive (U208, 8G)
11.23.068003 USB barcode scanner
02.01.210080 Wall mounting assembly
02.01.210173 Wall mounting assembly, no basket
02.01.101043 Basket (Only compatible with Wall Mount MS3R-30164)
11.18.078205 Security lock
02.01.101985 MT206 trolley assembly for iM50, no plug board
02.01.101986 MT207 trolley assembly for iM80, no plug board
02.04.101978 Trolley plug board assembly kit
11.13.01950 Three flat power cable, length 3 m
- 163 -
01.13.36014 Power cable, length 1.8 m, VDE
11.13.36015 Power cable, length 1.8 m, American standard
01.13.036106 Power cable, length 1.8 m, American standard, medical grade
11.13.114214 Ground Cable
02.01.210633 Recorder
01.18.052307 Sandisk SD Card (CLASS 4, 8G)
- 164 -
Patient Monitor User Manual Product Specification
A Product Specification
A.1 Classification
Anti-electroshock type Class I equipment and internal powered equipment
Anti-electroshock degree ECG (RESP), TEMP, IBP, C.O., Quick Temp CF
SpO2, NIBP, CO2, AG BF
Ingress Protection IPX1 (No protection against ingress of water if configured
with Quick TEMP module)
Disinfection/sterilization method Refer to Chapter Care and Cleaning for details.
Working system Continuous operation equipment
Compliant with Standards IEC 60601-1: 1988+A1: 1991+A2: 1995; EN 60601-1:
1990+A1: 1993+A2: 1995; IEC 60601-1-2: 2001+A1:
2004; EN 60601-1-2: 2001+A1: 2006; ISO 9919, ISO
21647, IEC/EN 60601-2-27, IEC/EN 60601-2-30, IEC/EN
60601-2-34, IEC/EN 60601-2-49, ANSI/AAMI SP10,
AAMI/ANSI EC13, EN12470-4 EN1060-1 EN1060-3,
EN1060-4, IEC/EN 60601-2-25*, IEC/EN 60601-2-51*
(Symbol * means this standard only applicable to iM80)
A.2 Physical Specifications

A.2.1 Size and Weight
Product Size Weight (standard
configuration, without
battery)
iM50 261 mm (L) × 198 mm (W) × 215 mm (H) <3.6 kg
iM60 303mm(L) × 161mm(W) × 254mm(H) <4.5 kg
iM70 328mm(L) × 158mm(W) × 285mm(H) <5.5 kg
iM80 370 mm (L) × 175 mm (W)× 320 mm (H) <7 kg
A.2.2 Environment Specification

The monitor may not meet the performance specifications given here if stored or used outside the
specified temperature and humidity ranges.
When the monitor and related products have differing environmental specifications, the effective
range for the combined products is that range which is common to the specifications for all
products.
- 165 -
Temperature
Working +5qC ~ +40qC
Transport and Storage -20qC ~ +55qC
Humidity
Working 25% ~ 80% (non-condensing)
Transport and Storage 25% ~ 93% (non-condensing)

Altitude
Working 860hPa ~ 1060hPa
Transport and Storage 700hPa ~ 1060hPa
Power Supply 100V-240V~, 50Hz/60Hz
iM50 Current=1.0A-0.5A; Fuse: T 1.6AL, 250V
iM80 Current=1.4A-0.7A; Fuse: T 1.6AL, 250V
iM60/iM70 Current=1.4A-0.7A; Fuse: T3.15AH, 250V
A.2.3 Display
Product Display Messages
iM50 Display screen: 8.4 inch color TFT, A maximum of 11 waveforms
supporting touch screen One power LED
Resolution: 800×600 Two alarm LED
One charge LED
One charge LED
One charge LED
- 166 -
iM80 Display screen: 15 inch color TFT, A maximum of 13 waveforms

Resolution: 1024 × 768 Two alarm LED
One charge LED
A.2.4 Battery Specification

Operating Time iM50 2.1Ah 180 min or longer
4.2Ah 420 min or longer
iM80 One battery (4.2Ah) 120 min or longer

Two batteries (2*4.2Ah) 240 min or longer
iM60/iM70 2.1Ah 150 min or longer
4.2Ah 300 min or longer
Condition At 25qC, with (a) new fully charged battery/batteries, continuous SpO2
measurement and NIBP automatic measurement mode at interval of 15
minutes, ECG/TEMP module connected, recording at interval of 10
minutes, brightness set to “1”
Charge Time iM50 2.1Ah 200 min or shorter
4.2Ah 380 min or shorter
iM80 One battery (4.2Ah) 320 min or shorter
Two batteries (2*4.2Ah) 560 min or shorter
iM60/iM70 2.1Ah 200 min or shorter
4.2Ah 360 min or shorter
Condition Monitor is on or in standby mode.
A.2.5 Recorder
Record Width 48 mm
Paper Speed 25 mm/s, 50 mm/s
Trace 3
Recording types Continuous real-time recording
8 seconds real-time recording
Time recording
- 167 -
Alarm recording
Trend graph recording
Trend table recording
NIBP review recording
Arrhythmia review recording
Alarm review recording
Drug calculation titration recording
Hemodynamic Calculation result recording
12-lead analysis recording
C.O. measurement recording
A.2.6 Data Storage

Trend graph/trend table review 1 hour, at 1 Second Resolution by default
120 hrs, at 1 min. Resolution by default
Alarm/Monitoring Event data Up to 60 sets
NIBP Measurement Review 1200 sets
Arrhythmia events Up to 60 sets
12-lead Diagnosis Review Up to 50 sets
A.3 ECG
3-Lead: I, II, III
Lead Mode 5-Lead: I, II, III, aVR, aVL, aVF, V
12-Lead: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform 3-Lead: 1-channel waveform;
5-Lead: 2-channel waveform, max. seven waveforms;
12-Lead: 2-channel waveform, a maximum of 13
waveforms;
Lead naming style AHA, IEC
1.25mm/mV (×0.125), 2.5mm/mV (×0.25), 5mm/mV
Display Sensitivity (×0.5), 10mm/mV (×1), 20mm/mV (×2), 40mm/mV (×4),
AUTO gain
Waveform Speed 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
- 168 -
Diagnosis: 0.05Hz to 150Hz

Bandwidth (-3dB) Monitor: 0.5Hz to 40Hz
Surgery: 1Hz to 20Hz
Diagnosis: >95dB (the Notch filter is off)
CMRR (Common Mode
Monitor: >105dB (the Notch filter is on)
Rejection Ratio)
Surgery: >105dB (the Notch filter is on)
In diagnosis, monitoring, surgery mode: 50Hz/60Hz (Notch
Notch
filter can be turned on or off manually)
Differential Input Impendance >5M
Input Signal Range ±10mV (peak-to-peak value)
Accuracy of Input Signal The total error and frequency response comply with
Reconstruction ANSI/AAMI EC13:2002, Sect. 4.2.9.8.
Electrode Offset Potential
±500mV
Tolerance
Auxiliary Current (Leads off Active electrode: <100nA

detection) Reference electrode: <900nA
Recovery time after
<5s
Defibrillation
Leakage current of patient <10A
Scale signal 1mV(peak-to-peak value), accuracy is ±5ˁ
System noise <30VPP

ESU Protection Recovery time: 10s
Pace Pulse
Pulse is marked if the requirements of ANSI/AAMI
EC13:2002, Sect. 4.1.4.1 are met:
Pulse indicator Amplitude: ±2 mV ~ ±700 mV
Width: 0.1 ms ~2 ms
Ascending time: 10 s ~ 100 s
Pulse is rejected if the requirements of ANSI/AAMI EC13:
2002, Sect. 4.1.4.1 are met:
Pulse Rejection Amplitude: ±2 mV ~ ±700 mV

Width: 0.1 ms ~2 ms
Ascending time: 10 s ~100 s
- 169 -
Minimum input slew rate >2.5V/S

Heart rate
Measurement Range ADU: 15 bpm ~ 300 bpm
PED/NEO: 15 bpm ~ 350 bpm
Accuracy ±1% or ±1 bpm, whichever is greater
Resolution 1 bpm
PVC
Measurement Range ADU: 0~300 PVCs/ min
PED/NEO: 0~350 PVCs/ min
Resolution 1 PVCs/min
ST value(only applicable to adult˅
Measurement Range -2.0 mV ~ +2.0 mV
Accuracy -0.8 mV ~ +0.8 mV: ±0.02 mV or 10% (), whichever is
greater.
Beyond this range: undefined
Resolution 0.01 mV
HR averaging method
Method 1 Heart rate is computed by excluding the minimum and
maximum values from the 12 most recent RR intervals and
averaging the residual 10 RR intervals.
Method 2 If each of three consecutive RR intervals is greater than
1200ms, then the four most recent RR intervals are
averaged to compute the HR.
Range of Sinus and SV Rhythm
Tachy ADU: 120 bpm ~ 300 bpm

Normal ADU: 41 bpm ~ 119 bpm
PED/NEO: 61 bpm ~159 bpm
Brady ADU: 15 bpm ~ 40 bpm
Range of Ventricular Rhythm
Ventricular Tachycardia The interval of 5 consecutive ventricular beats is less than
600 ms
- 170 -
Ventricular Rhythm The interval of 5 consecutive ventricular beats ranges from

600 ms to 1000 ms
Ventricular Bradycardia The interval of 5 consecutive ventricular beats is more than
1000 ms
Maximum Start-up alarm time for Tachycardia
Ventricular Tachycardia Gain 1.0: 10 s
1 mV 206bpm Gain 0.5: 10 s
Gain 2.0: 10 s
Ventricular Tachycardia Gain 1.0: 10 s
2 mV 195bpm Gain 0.5: 10 s
Gain 2.0: 10 s
Response time of Heart Rate HR range: 80 bpm ~ 120 bpm
Meter to Change in HR Range : 7s ~ 8s, average is 7.5s
HR range: 80bpm ~ 40bpm
Range : 7s ~ 8s, average is 7.5s
Tall T-wave Rejection Complies with ANSI/AAMI EC13: 2002 Sect. 4.1.2.1 C)
minimum recommended 1.2mV T-Wave amplitude
Accuracy of Heart Rate Meter Complies with ANSI/AAMI EC13: 2002 Sect.4.1.2.1 e)
and Response to Irregular The HR value displays after a stable period of 20s:
Rhythm
Ventricular bigeminy: 80bpm±1bpm
Slow alternating ventricular bigeminy: 60bpm±1bpm
Rapid alternating ventricular bigeminy: 120bpm±1bpm
Bidirectional systoles: 91bpm±1bpm
16 different arrhythmia analysis ASYSTOLE VFIB/VTAC COUPLET
classification VT>2 BIGEMINY TRIGEMINY
(applicable to adult and VENT R on T PVC
pediatric)
TACHY BRADY MISSED BEATS
IRR VBRADY PNC
PNP
- 171 -
12-lead ECG Synchronization Average parameters of heart beat

Analysis
Heart rate (bpm)
Time limit of P wave (ms)
PR interval (ms)
QRS interval (ms)
QT/QTC (ms)
P-QRS-T AXIS
ECG Analog Output
Diagnosis: 0.05Hz ~ 100Hz
Bandwidth (-3dB; reference
Monitor: 0.5Hz ~ 40Hz
frequency: 10Hz)
Surgery: 1Hz ~ 20Hz
Maximum transmission delay 500ms (in diagnostic mode, and with notch off)
Sensitivity 1V/mV ±10%
PACE rejection/enhancement Without Pace enhancement or pace rejection
Waveform Display Consistent with the calculation leads.
Compliant with Standard and Complies with the requirements in terms of short circuit
Directive protection and leakage current in EN60601-1.
Defib Sync Pulse
Output wave Square pulse
Output impedance <500
Maximum Time Delay 35mS (R-wave peak to leading edge of pulse)

High level: 3.5 to 5 V, providing a maximum of 1 mA
output current;
Amplitude
Low level: < 0.5V, receiving a maximum of 5 mA input
current.
Minimum required R wave
0.3mV
amplitude
Pulse width 100ms ± 10%
Limited current 15 mA rating
Rising and falling time < 1 ms
- 172 -
A.4 RESP
Measurement method Trans-thoracic impedance
Measurement lead Lead Options are lead I and II. The default lead is lead II.
Waveform amplitude h0.25, ×0.5, ×1, ×2, ×3, ×4, ×5
Waveform speed 6.25mm/s, 12.5mm/s, 25.0mm/s, , 50mm/s
Respiration excitation < 300 A, sinusoid, 62.8 kHz (r 10%)
waveform
Measuring sensitivity 0.3 (base impedance 200 to 4500 )
Base impedance range 200 to 2500 (cable resistance = 0 K)
2200 to 4500 (leads cables 1K resistance)
Maximum dynamic range 500 base impedance, 3 variable impedance
Waveform bandwidth 0.2 to 2.5 Hz (-3 dB)
Differential input impedance >5 M
RR measuring range
Adult 0 to 120 rpm
Neo/Ped 0 to 150 rpm
Resolution 1 rpm
Accuracy
Adult 6 to 120 rpm: r2 rpm
0 to 5 rpm: not specified
Neo/Ped 6 to 150 rpm: r2 rpm
0 to 5 rpm: not specified
Apnea Alarm delay 10s, 15s, 20s, 25s, 30s, 35s, 40s. The default value is 20s.
- 173 -
A.5 NIBP
EDAN Module
Measurement Method Oscillometric
Mode Manual, Auto, Continuous
Measuring interval in AUTO 1/2/3/4/5/10/15/30/60/90/120/240/480 min
Mode
Continuous 5min, interval is 5s
Measuring type SYS, DIA, MAP, PR
Measurement Range
Adult mode SYS: 40 mmHg ~ 270 mmHg
DIA: 10 mmHg ~ 215 mmHg
MAP: 20 mmHg ~ 235 mmHg
Pediatric mode SYS: 40 mmHg ~ 200 mmHg
Neonatal mode SYS: 40 mmHg ~ 135 mmHg
Cuff pressure measuring range 0 mmHg ~ 300 mmHg
Accuracy
Maximum mean error ±5mmHg
Maximum standard deviation 8mmHg
Pressure resolution 1mmHg
Maximum measuring period
Adult/Pediatric 120s
Neonate 90s
Typical measuring period 30s ~ 45s (depend on HR/motion disturbance)
Overpressure protection
Adult 297±3mmHg
Pediatric 240±3mmHg
Neonatal 147±3mmHg
- 174 -
PR
Measurement range 40 bpm ~240bpm
Accuracy ±3bpm or 3.5%, whichever is greater
Omron Module
Method Oscillometric
Mode Manual, Auto, Continuous
Measuring Interval in AUTO Mode 1/2/3/4/5/10/15/30/60/90 min, 2/4/8h
Continuous 5min, interval is 5s
Maximum measurement period Adult/ Pediatric: 160s
Neonatal: 80s
PR Measurement Range Adult/ Pediatric mode: 40bpm ~ 200bpm
Neonatal mode: 40 bpm ~ 240bpm
PR Accuracy r 2 bpm or 2% of the readings
Measurement Range
Adult/ Pediatric Mode SYS: 60 mmHg ~ 250 mmHg
Neonatal Mode SYS: 40 mmHg ~ 120 mmHg
Cuff pressure measuring range 0 mmHg ~ 300 mmHg
Pressure Resolution 1mmHg
Accuracy
Maximum Mean Error ±5mmHg
Maximum Standard Deviation 8mmHg
- 175 -
A.6 SpO2
EDAN Module
Measurement Range 0 ~ 100 %
Resolution 1%
Accuracy
Adult (including Pediatric) r2 % (70%~100% SpO2)
Undefined (0~69% SpO2)
Neonate r3 % (70%~100% SpO2)
Undefined (0~69% SpO2)
Pulse Rate
Measuring Range 25bpm ~ 300bpm
Resolution 1bpm
Accuracy r2bpm
Data update period 1s
Sensor Wave length: Red light: 660r3 nm;
Infrared light: 905r5 nm
Emitted light energy: <15mW
Nellcor Module
Measuring Range 1% ~ 100%
Resolution 1%
Data update period 1s
Sensor Type Accuracy
Accuracy
DS-100A, OXI-A/N r 3%(70% ~ 100% SpO2)
* When the sensor is used to neotate as recommendation, the specified accuracy range of the
neotate is always higher ±1 than adult.
Pulse Rate
Measuring Range 20bpm ~ 300bpm
Resolution 1bpm
Accuracy r 3bpm (20bpm ~ 250bpm)
Sensor Wave length: approximately 660 and 900nm
Emitted light energy: <15mW
- 176 -
A.7 TEMP
Measurement method Thermal resistance
Channel 2
Sensor type YSI-10K and YSI-2.252K
Measuring Range 0 qC ~ 50 qC
Resolution 0.1qC
Accuracy (Without sensor) r0.1qC
Unit ć, ̧
Refresh Time 1s ~ 2s
A.8 Quick TEMP

25qC ~ 45qC(monitoring mode)
Measuring Range
35.5ć̚42ć(prediction mode)
Operating Temp 10qC ~ 40qC
Sensor Type Oral/Axillary sensor, Rectal sensor
Resolution 0.1qC
Accuracy(without sensor) r0.1qC (25qC ~ 45qC) (monitoring mode)
Response time < 60s
Update time 1s ~ 2s
Warm-up time Less than 10 seconds
Prediction time Less than 30 seconds
A.9 IBP
Measurement method Direct invasive measurement
Channel iM80: 4 channels
iM50/iM60/iM70: 2 channels
Pressure sensor
Sensitivity 5 (V/V/mmHg)
Impedance range 300 to 3000
Frequency response d.c. to 12.5 or 40 Hz
Zero Range: r200 mmHg
- 177 -
Unit kPa, mmHg

Measuring range
Art 0 to 300 mmHg
PA -6 to +120mmHg
CVP/RAP/LAP/ICP -10 to +40 mmHg
P1/P2 -50 to +300 mmHg
Resolution 1 mmHg
Accuracy (without sensor) r 2 % or 1 mmHg, whichever is greater
A.10 CO2
EDAN Module
Intended patient Adult, pediatric, neonatal

Measurement
Non-dispersive infrared gas analysis (NDIR)
method
Unit mmHg, %, kPa
CO2 0 mmHg ~ 150 mmHg (0 % ~ 20%)
Measuring Range
AwRR 2 rpm ~ 150 rpm
EtCO2 0.2mmHg (0 mmHg~ 70mmHg), 0.5mmHg (70 ~ 100mmHg)
Resolution FiCO2 0.2mmHg
AwRR 1rpm
r 2 mmHg, 0mmHg ~ 40 Typical conditions:

mmHg Ambient temperature: 25r 3ć
Barometric pressure: 760r 10
r 5% of reading, 41 mmHg ~
mmHg
70 mmHg
Balance gas: N2
EtCO2 r 8% of reading, 71 mmHg ~ Respiratory rate: not exceed
Accuracy 100 mmHg 60rpm
r 10% of reading, 101 mmHg Sample gas flowrate:
~ 150 mmHg 100ml/min
r12% or r 4 mmHg of
All conditions
reading, whichever is greater
AwRR r 1 rpm
Sample gas
70ml/min or 100ml/min, optional (r15ml/min)
Flowrate
- 178 -
Short term drift: drift over 4 hours < 0.8 mmHg

Stability
Long term drift: 120 hours
Display reading within 20s; reach to the designed accuracy within 2
Warm-up time
minutes.
Rise time 400ms (typical value, using water trap, sample gas flowrate:100ml/min
<4s (water trap) with 2m gas sampling tube, sample gas flowrate:
Response time
100ml/min
Work mode Standby, measure; default: measure
Respiratory
The value of concentration change is greater than 1 vol%.
inspection
Range: 0%~100%
O2 compensation Resolution: 1%
Default: 16%
Range: 0%~100%
N2O
Resolution: 1%
compensation
Default: 0%
Range: 0%~20%
AG
Resolution: 0.1%
compensation
Default: 0%
Humidity
compensation ATPD, BTPS (default)
method
Calibration Support
Alarm EtCO2, FiCO2, AwRR
Apnea alarm 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s.
delay
Respironics Module
Intended patient Adult, pediatric, neonatal
Measurement method Infra-red Absorption Technique
Unit mmHg, %, Kpa
Measuring Range
EtCO2 0 mmHg ~ 150 mmHg
FiCO2 3 mmHg ~50 mmHg
AwRR 2 rpm ~ 150 rpm(sidestream)
0 rpm ~ 150 rpm(mainstream)
Resolution
EtCO2 1mmHg
- 179 -
FiCO2 1mmHg
AwRR 1 rpm
EtCO2 Accuracy r 2 mmHg, 0 to 40 mmHg
r 5 % of reading, 41 to 70 mmHg
r 12 % of reading, RESP measurement value exceeds
80rpm (sidestream)
AwRR Accuracy r 1 rpm
Sample Gas Flowrate 50fml/min
(sidestream)
Stability
Short Term Drift Less than 0.8 mmHg over four hours
Long Term Drift Accuracy specification will be maintained over a 120 hour
period
O2 Compensation
Range 0 ~ 100%
Resolution 1%
Default 16%
GAS Compensation
Range 0 ~ 20%
Resolution 0.1%
Default 0.0%
Zero Support
Work Mode Standby, Measurement
Barometric pressure User setup
compensation
Balance gas compensation Including Helium, N2O and room air
Apnea Alarm Delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s.
Interfering Gas Effect on EtCO2 Measurement Values:

Gas or vapor Gas level (%) Quantitative effect/Comments
Nitrous oxide 60 Dry and Saturated Gas
- 180 -
Halothane 4 0 – 40 mmHg: ± 1 mmHg additional error

Enflurane 5 41 – 70 mmHg: ± 2.5% additional error
Isoflurane 5 71 – 100 mmHg: ± 4% additional error
Sevoflurane 5 101 – 150 mmHg: ± 5% additional error
Xenon 80 *Additional worst case error when compensation
Helium 50 for PB, O2, N2O, anesthetic agents, or helium is
correctly selected for the actual fractional gas
Desflurane 15 constituents present.
Desflurane:
The presence of desflurane in the exhaled breath at
concentrations greater than 5% will positively bias
Carbon Dioxide values by up to an additional 3
mmHg at 38mmHg.
Xenon:
The presence of Xenon in the exhaled breath will
negatively bias Carbon Dioxide values by up to an
additional 5 mmHg at 38mmHg.
Barometric Pressure on EtCO2 Measurement Values:

Quantitative effect
Ambient Barometric, Operational
0 – 40 mmHg: ± 1 mmHg additional error
41 – 70 mmHg: ± 2.5% additional error
71 – 100 mmHg: ± 4% additional error
101 – 150 mmHg: ± 5% additional error
*Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium
is correctly selected for the actual fractional gas constituents present.
A.11 C.O.
Intended patient Adult
Measurement method Thermodilution Technique
Measuring range
C.O. 0.1 L/min ~ 20L/min
TB 23qC ~ 43qC
TI -1qC ~ 27qC
Resolution
C.O. 0.1L/min
- 181 -
TB, TI +0.1qC
Accuracy
C.O. ±5% or 0.2 L/min, whichever is greater
TB r0.1qC(without sensor)
TI r0.1qC(without sensor)
A.12 AG
A.12.1 Phasein Sidestream
Temperature
Humidity
Altitude
Module Type ISA AX+ Analyzer Displaying the concentration of CO2, N2O,
and two anaesthesia agent and identifying the
anaesthesia agent automatically (portable
module)
ISA OR+ Analyzer Displaying the concentration of CO2, O2, N2O,
and two anaesthesia agent and identifying the
anaesthesia agent automatically (portable
module)
Measurement CO2 , N2O , O2, Halothane (HAL), Isoflurane(ISO), Enflurane(ENF),
Parameters Sevoflurane(SEV) , Desflurane(DES), awRR, MAC
Measurement CO2, N2O, Anaesthesia Agent: infra-red absorption characteristic;

Principle O2: Paramagnetic method
Sampling Flow 50±10ml/min
Rate
Work Mode Measurement
Warm-up Time < 20s
- 182 -
Typical Rise Time CO2 200ms

HAL, ISO, ENF, SEV, DES 350ms
N2O 350ms
O2 450ms
Primary 0.15 vol%
Anaesthesia Agent
Threshold
Second Anaesthesia 0.2 vol% + 10%
Agent Threshold
Agent < 20 seconds (typically < 10 seconds)
Identificaiton Time
Total System < 3 seconds
Response Time
Data Update Time 1 second
Accuracy(Standard Conditions)
GAS Measurement Range Accuracy
CO2 0 to 15 vol% ±(0.2 vol% + 2% of reading)
15 to 25 vol% Unspecified
N2O 0 to 100 vol% ±(2 vol% + 2% of reading)
HAL, ENF, ISO 0 to 8 vol % ±(0.15 vol% + 5% of reading)
8 to 25 vol % Unspecified
SEV 0 to 10 vol % ±(0.15 vol% + 5% of reading)
DES 0 to 22 vol % ±(0.15 vol% + 5% of reading)
O2 0 to 100 vol % ±(1 vol% + 2% of reading)
Apnea Alarm Delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s.
Zero Support
O2 Compensation Support
N2O Compensation Support
Interfering gas and vapor effects
Gas or vapour Gas level CO2 Agents N2O
ISA CO2 ISA AX+
- 183 -
N2O4) 60 vol% _ 2) _ 1) _ 1) _ 1)
HAL4) 4 vol% _ 1) _ 1) _ 1) _ 1)
ENF, ISO, SEV4) 5 vol% +8% of _ 1) _ 1) _ 1)
reading 3)
DES4) 15 vol% +12% of _ 1) _ 1) _ 1)
reading 3)
Xe(Xenon)4) 80 vol% -10% of _ 1) _ 1)
reading 3)
He(Helium) 4) 50 vol% -6% of _ 1) _ 1)
reading 3)
Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants4)
_ 1) _ 1) _ 1) _ 1)
C2H5OH(Ethanol) 0.3 vol%
4)
_ 1) _ 1) _ 1) _ 1)
C3H7OH 0.5 vol%
(Isopropanol) 4)
_ 1) _ 1) _ 1) _ 1)
CH3COCH3 1 vol%
(Acetone) 4)
CH4(Methane) 4) 3 vol% _ 1) _ 1) _ 1) _ 1)
_ 1) _ 1) _ 1) _ 1)
CO(Carbon 1 vol%
monoxide) 5)
_ 1) _ 1) _ 1) _ 1)
NO(Nitrogen 0.02 vol%
monoxide)
O25) 100 vol% _ 2) _ 2) _ 1) _ 1)
Note 1: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the
CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50
vol% Helium, the actual measured CO2 concentration will typically be (1-0.06)*5.0 vol% =4.7
vol% CO2.
Note 2: In addition to the EN ISO 21647 standard.
A.12.2 Phasein Mainstream

Temperature
- 184 -
Humidity
Altitude
Module Type IRMA AX+ Displaying the concentration of CO2, N2O
and two anaesthesia agent and indentifying
two anaesthesia agent
Measurement CO2, N2O, HAL, Isoflurane(ISO), Enflurane(ENF), Sevoflurane(SEV),
Parameters Desflurane(DES), awRR, MAC
Measurement CO2, N2O, anaesthesia agent: infra-red absorption characteristic

Principle
Warm-up Time Concentrations are reported and the automatic agent indentification is
running within 10 seconds.
20 seconds for IRMA AX+.
Rise Time CO2 90ms
N2O 300ms
HAL, ISO, ENF, SEV, DES 300ms
Primary Agent 0.15 vol%
Threshold
Secondary Agent 0.2 vol% + 10% of total agent concentration
Threshold
Agent < 20 seconds (typically less than 10 seconds)
Identificaiton
Time
Response Time < 1 second
Data Update 1 second
Time
Accuracy(Standard Conditions)
Gas Range Accuracy
CO2 0 ~ 10 vol% ±(0.2 vol% + 2% of reading)
10 ~ 15 vol% ±(0.3 vol% + 2% of reading)
15 ~ 25 vol% Unspecified
- 185 -
N2O 0 to 100 vol% ±(2 vol% + 2% of reading)

HAL 0 to 8 vol% ±(0.15 vol% + 5% of reading)
ISO 8 to 25 vol% Unspecified
ENF
SEV 0 to 10 vol% ±(0.15 vol% + 5% of reading)
DES 0 to 22 vol% ±(0.15 vol% + 5% of reading)
AwRR accuracy ±1rpm
Real-time gas Support
concentration
monitoring
Zero Support
Work Mode Measurement
Apnea Alarm 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s.
Delay
Interfering gas and vapour effects
Gas or vapour Gas level CO2 Agents N2O
IRMA CO2 IRMA AX+
N2O4) 60 vol% _ 1&2) _ 1&2) _ 1) _ 1)
HAL4) 4 vol% _ 1) _ 1) _ 1) _ 1)
ENF, ISO, SEV4) 5 vol% +8% of _ 1) _ 1) _ 1)
reading 3)
DES4) 15 vol% +12% of _ 1) _ 1) _ 1)
reading 3)
Xe(Xenon)4) 80 vol% -10% of _ 1) _ 1)
reading 3)
He(Helium) 4) 50 vol% -6% of _ 1) _ 1)
reading 3)
Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants4)
_ 1) _ 1) _ 1) _ 1)
C2H5OH(Ethanol) 0.3 vol%
4)
_ 1) _ 1) _ 1) _ 1)
C3H7OH 0.5 vol%
(Isopropanol) 4)
- 186 -
_ 1) _ 1) _ 1) _ 1)
CH3COCH3 1 vol%
(Acetone) 4)
CH4(Methane) 4) 3 vol% _ 1) _ 1) _ 1) _ 1)
_ 1) _ 1) _ 1) _ 1)
CO(Carbon 1 vol%
monoxide) 5)
_ 1) _ 1) _ 1) _ 1)
NO 0.02 vol%
O25) 100 vol% _ 1&2) _ 1&2) _ 1) _ 1)
Note 1: For probes not measuring N2O and/or O2 the concentrations shall be set from monitor.
(IRMA CO2 measures neither N2O, nor O2. IRMA AX+ does not measure O2.)
Note 2: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the
CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50
vol% Helium, the measured CO2 concentration will typically be (1-0.06)*5.0 vol% =4.7 vol%
CO2.
Note 3: In addition to the EN ISO 21647 standard.
- 187 -
Patient Monitor User Manual EMC Information
B EMC Information
- Guidance and Manufacture’s Declaration
B.1 Electromagnetic Emissions - for all EQUIPMENT and
SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions The monitor uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference
in nearby electronic equipment.
RF emission The monitor is suitable for use in all
Class A establishments, other than domestic
CISPR 11
establishments and those directly connected to
Harmonic emissions the public low-voltage power supply network
Class A
IEC/EN 61000-3-2 that supplies buildings used for domestic
purposes.
Voltage fluctuations/
flicker emissions Complies
IEC/EN 61000-3-3
B.2 Electromagnetic Immunity - for all EQUIPMENT and

SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC/EN 60601 test level Compliance level environment -
guidance
Electrostatic r6 kV contact r6 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile.
r8 kV air r8 kV air
IEC/EN 61000-4-2 If floor are covered
with synthetic material,
the relative humidity
should be at least 30%.
- 188 -
Electrical fast r2 kV for power supply r2kV for power Mains power quality
transient/burst lines supply lines should be that of a
typical commercial or
IEC/EN 61000-4-4 r1 kV for input /output r1 kV for input
hospital environment.
signal /output signal
Surge r1 kV for line to line r1 kV for line to Mains power quality
line should be that of a
IEC/EN 61000-4-5 r2 kV for line to ground
r2 kV for line to
ground
Power frequency 3A/m 3A/m Power frequency
(50/60Hz) magnetic fields should
be at levels
magnetic field characteristic of a
IEC/EN 61000-4-8 typical location in a
Voltage dips, short <5% UT <5% UT Mains power quality
interruptions and (>95% dip in UT) (>95% dip in UT) should be that of a
voltage variations typical commercial or
on power supply for 0.5 cycle for 0.5 cycle hospital environment. If
input lines the user of the Patient
IEC/EN Monitor requires
40% UT 40% UT
61000-4-11 continued operation
(60% dip in UT) (60% dip in UT) during power mains
for 5 cycles for 5 cycles interruptions, it is
recommended that the
Patient Monitor be
70% UT 70% UT powered from an
uninterruptible power
(30% dip in UT) (30% dip in UT)
supply or a battery.
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
NOTE UT is the a.c. mains voltage prior to application of the test level.
- 189 -
B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS

that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The Patient Monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of Patient Monitor should assure that it is used in such an
environment.
IEC/EN 60601 test Compliance Electromagnetic environment -
Immunity test
level level guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Patient Monitor, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms ª 3 .5 º
d « » P
IEC/EN 150 kHz to 80 MHz ¬ V1 ¼
61000-4-6
ª 3 .5 º
d « » P 80 MHz to 800 MHz
¬ E1 ¼
Radiated RF 3 V/m 3 V/m
ª7º
IEC/EN 80 MHz to 2.5 GHz d « » P 800 MHz to 2.5 GHz
61000-4-3 ¬ E1 ¼
Where P is the maximum output
power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
- 190 -
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Patient Monitor is
used exceeds the applicable RF compliance level above, the Patient Monitor should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Patient Monitor.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
B.4 Recommended Separation Distances

Recommended separation distances between
portable and mobile RF communications equipment and the monitor
The monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the monitor can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the monitor as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter(m)
output power of
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter
ª 3 .5 º ª 3 .5 º ª7º
(W) d « » P d « » P d « » P
¬ V1 ¼ ¬ E1 ¼ ¬ E1 ¼
0.01 0.12 0.12 0.23
0.1 0.36 0.37 0.74
1 1.16 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
- 191 -
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
- 192 -
Patient Monitor User Manual Default Settings
C Default Settings
This appendix documents the most important default settings of your monitor as it is delivered
from the factory.
Note: If your monitor has been ordered preconfigured to your requirements, the settings at
delivery will be different from those listed here.
C.1 Patient Information Default Settings

Patient Information Settings
Patient Type Adult
Pace Off
C.2 Alarm Default Settings

Alarm Settings
Pause Time 120s
Mute On
Sensor Off Alarm On
Alarm Latch Unlatch
C.3 ECG Default Settings

ECG Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit 120 160 200
Alarm Low Limit 50 75 100
Pace Off
Lead Type 5 Leads
Display Normal
Filter Monitor
Smart Lead Off Off
Heart Volume 2
ST Analysis ADU PED NEO
- 193 -
ST Analysis Off
Alarm Switch Off
Alarm Level Medium
Alarm Record Off
Alarm High Limit 0.2
(ST-X)
Alarm Low Limit -0.2
(ST-X)
X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5 or V6.
ARR Analysis
ARR Analysis On
PVCs Alarm Level Medium
PVCs Alarm Switch Off
PVCs Alarm Record Off
ARR Alarm Settings Alarm Switch Alarm Level Alarm Record
ASYSTOLE On High Off
VFIB/VTAC On High Off
R ON T On Medium Off
VT > 2 On Medium Off
COUPLET On Medium Off
PVC On Medium Off
BIGEMINY On Medium Off
TRIGEMINY On Medium Off
TACHY On Medium Off
BRADY On Medium Off
MISSEDBEATS On Medium Off
IRR On Medium Off
PNC On Medium Off
PNP On Medium Off
VBRADY On Medium Off
VENT On Medium Off
- 194 -
C.4 RESP
RESP Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Apnea Time 20s
Calculation Type Auto
Resp Type II
Sweep 12.5mm/s
Amplitude 1
C.5 SpO2
SpO2 Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Pitch Tone On
Sweep 12.5mm/s
C.6 PR
PR Settings ADU PED NEO
PR Source SpO2
Alarm Switch On
Alarm Record Off
Alarm Level Medium
- 195 -
Pulse Volume 3
Alarm Source Auto
C.7 NIBP
NIBP Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit (SYS) 160 120 90
Alarm Low Limit (SYS) 90 70 40
Alarm High Limit (Map) 110 90 70
Alarm Low Limit (Map) 60 50 30
Alarm High Limit (Dia) 90 70 60
Alarm Low Limit (Dia) 50 40 20
EDAN Module
Inflation value 160 140 100
Omron Module
Inflation value 180 180 120
Unit mmHg
Interval Manual
C.8 TEMP
TEMP Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit (T1) 39.0 39.0 39.0
Alarm Low Limit (T1) 36.0 36.0 36.0
Alarm High Limit (T2) 39.0 39.0 39.0
Alarm Low Limit (T2) 36.0 36.0 36.0
Alarm High Limit (TD) 2.0 2.0 2.0
- 196 -
Unit qC
C.9 Quick TEMP

Quick TEMP Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit (T1) 39.0 39.0 /
Alarm Low Limit (T1) 36.0 36.0 /
Unit qC
C.10 IBP
IBP Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Unit mmHg
Filter 12.5Hz
SYS, DIA, MAP SYS, DIA, MAP SYS, DIA, MAP
Alarm High Limit (ART, 160, 90, 110 160, 90, 110 160, 90, 110
P1, P2)
Alarm Low Limit (ART, 90, 50, 70 90, 50, 70 90, 50, 70
P1, P2)
Alarm High Limit (PA) 35, 16, 20 35, 16, 20 35, 16, 20
Alarm Low Limit (PA) 10, 0, 0 10, 0, 0 10, 0, 0
MAP MAP MAP
Alarm High Limit (CVP, 10 10 10
RAP, LAP, ICP)
Alarm Low Limit (CVP, 0 0 0
RAP, LAP, ICP)
- 197 -
C.11 CO2
CO2 Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Work Mode Standby
Unit mmHg
Apnea Time 20s
O2 Compensate 16%
Anes Agent 0%
Alarm High Limit (EtCO2) 50 50 45
Alarm Low Limit (EtCO2) 15 20 30
Alarm High Limit (FiCO2) 4 4 4
Alarm High Limit (AWRR) 30 30 100
Alarm Low Limit (AWRR) 8 8 30
Sweep 12.5mm/s
Amplitude Low
C.12 C.O.
C.O. Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit (TB) 43.0 43.0 43.0
Alarm Low Limit (TB) 23.0 23.0 23.0
Injective Temperature Auto
Source
Temperature Unit qC
Interval 30
Constant 0.542
- 198 -
C.13 AG
AG Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Work Mode Measure
Apnea Time 20s
Unit %
O2 Compensate OFF
Anes Agent HAL
Alarm High Limit (EtAA) 8.0 8.0 8.0
Alarm Low Limit (EtAA) 0.0 0.0 0.0
Alarm High Limit (FiAA) 6.0 6.0 6.0
Alarm Low Limit (FiAA) 0.0 0.0 0.0
Alarm High Limit (EtN2O) 55 55 55
Alarm Low Limit (EtN2O) 0 0 0
Alarm High Limit (FiN2O) 53 53 53
Alarm Low Limit (FiN2O) 0 0 0
Alarm High Limit (EtO2) 90.0 90.0 90.0
Alarm Low Limit (EtO2) 18.0 18.0 18.0
Alarm High Limit (FiO2) 88.0 88.0 88.0
Alarm Low Limit (FiO2) 18.0 18.0 18.0
Sweep 12.5mm/s
Amplitude 2
- 199 -
Patient Monitor User Manual Abbreviation
D Abbreviations
Abbr English Full Name/Description
AC Alternating current
Adu Adult
AG Anaesthesia gas
Art Arterial
aVF Left foot augmented lead
aVL Left arm augmented lead
aVR Right arm augmented lead
awRR Airway respiration rate
BP Blood pressure
BTPS Body temperature and pressure, saturated
CI Cardiac index
C.O. Cardiac output
CISPR International Special Committee on Radio Interference
CMS Central monitoring system
CO2 Carbon dioxide
COHb Carboxyhemoglobin
DC Direct current
Des Desflurane
Dia Diastolic
ECG Electrocardiogram
EEC European Economic Community
EMC Electromagnetic compatibility
EMI Electromagnetic interference
Enf Enflurane
ESU Electrosurgical unit
Et End-tidal
EtCO2 End-tidal carbon dioxide
EtN2O End-tidal nitrous oxide
- 200 -
Eto Ethylene oxide

EtO2 End-tidal oxygen
FDA Food and Drug Administration
Fi Fraction of inspired
FiCO2 Fraction of inspired carbon dioxide
FiN2O Fraction of inspired nitrous oxide
FiO2 Fraction of inspired oxygen
Hal Halothane
Hb Hemoglobin
Hb-CO Carbon mono-xide hemoglobin
HR Heart rate
IBP Invasive blood pressure
ICP Intracranial pressure
ICU Intensive care unit
ID Identification
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronic Engineers
Iso Isoflurane
LA Left arm
LAP Left atrial pressure
LCD Liquid crystal display
LED Light emitting diode
LL Left leg
MAP Mean arterial pressure
MDD Medical Device Directive
MetHb Methemoglobin
MRI Magnetic resonance imaging
N/A Not applied
N2 Nitrogen
N2O Nitrous oxide
Neo Neonate
NIBP Non-invasive blood pressure
- 201 -
O2 Oxygen
oxyCRG Oxygen cardio-respirogram
PA Pulmonary artery
PAWP Pulmonary artery wedge pressure
Ped Pediatric
Pleth Plethysmogram
PR Pulse rate
PVC Premature ventricular complex
R Right
RA Right arm
RAP Right atrial pressure
Resp Respiration
RHb Reduced hemoglobin
RL Right leg
RR Respiration Rate
Sev Sevoflurane
SYS Systolic pressure
TB Blood Temperature
TD Temperature difference
TEMP Temperature
USB Universal serial bus
- 202 -

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About this Manual

Responsibility of the Manufacturer

Chapter 1 Intended Use and Safety Guidance

1.2 Safety Guidance

1.3 Explanation of Symbols on the Monitor

This symbol indicates that the instrument is IEC/EN 60601-1 Type

Symbol for “Caution”

Equipotential grounding terminal

Power Supply switch

USB (Universal Serial Bus) Connection

Audio alarm is off

VGA output, External Monitor

Nurse call port

Signal output port

Authorized representative in the European community

P/N Part Number

Consult Instructions For Use

Gas outlet (evac)

ISA equipped to measure CO2 only.

ISA equipped to measure multiple gases.

Federal (U.S.) Law restricts this device to sale by or on the order of a

(Only applicable to iM50 and iM80) With respect to electrical shock,

2.1 Initial Inspection

2.2 Mounting the Monitor

2.2.1 Installing Wall Mount for the Monitor

2.4 Checking Out the Monitor

2.5 Checking the Recorder

2.6 Setting the Date and Time

2.7 Handing Over the Monitor

2.8 FCC Statement*

cause harmful interference to radio communications. However, there is no guarantee that

This device complies with Part 15 of FCC Rules.

Operation is subject to the following two conditions:

2.9 FCC RF Radiation Exposure Statement*

Chapter 3 Basic Operation

8 Start / Stop Recording — Press this button to start a real-time recording.

3.1.2 Rear View

1 Equipotential grounding terminal, if the monitor or other processing

5 Defibrillator synchronization/ analog output/ nurse call port:

3.1.3 Side View

3.2 Operating and Navigating

14 Shortcut key area

3.2.1 Using Keys

Menu – enter the main setup menu.

Perform a 12-lead analysis Switch to the standard screen

Exit from 12-lead analysis Switch to the OxyCRG screen

Access the 12-lead review Switch to the large font screen

Perform 12-lead record Set the module switch

Admit a patient Change the key volume

Review the trend graph Adjust the screen brightness

Review the trend table Zero the IBP sensor

Review the alarm event Alarm setup

Access the NIBP review Change the beat volume

Access the ARR review Enter standby mode

Switch to the trend screen Enter night mode

3.3 Operating Mode

3.3.2 Standby Mode

3.3.3 Night Mode

z Select the shortcut key on the main screen, or

1. Alarm pause symbol