Manual de Usuario EDAN m80
Manual de Usuario EDAN m80
Manual de Usuario EDAN m80
P/N: 01.54.455473-10
Release Date: Jan. 2012
Copyright EDAN INSTRUMENTS, INC. 2012. 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. Users operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not 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.
II
Table of Contents
Chapter 1 Indication for Use and Safety Guidance ........................................................................ 1
1.1 Indication for Use................................................................................................................... 1
1.2 Safety Guidance ..................................................................................................................... 1
1.3 Explanation of Symbols on the Monitor ................................................................................ 3
Chapter 2 Installation ........................................................................................................................ 7
2.1 Initial Inspection..................................................................................................................... 7
2.2 Mounting the Monitor ............................................................................................................ 7
2.2.1 Installing Wall Mount for the Monitor ........................................................................ 7
2.3 Connecting the Power Cable .................................................................................................. 7
2.4 Checking Out the Monitor ..................................................................................................... 7
2.5 Checking the Recorder ........................................................................................................... 8
2.6 Setting the Date and Time ...................................................................................................... 8
2.7 Handing Over the Monitor ..................................................................................................... 8
Chapter 3 Basic Operation ................................................................................................................ 9
3.1 Introducing iM50/iM80 Series ............................................................................................... 9
3.1.1 iM50 Major Parts and Keys ........................................................................................ 9
3.1.2 iM80 Major Parts and Keys ...................................................................................... 12
3.1.3 iM50/iM80 Configuration ......................................................................................... 15
3.2 Operating and Navigating .................................................................................................... 15
3.2.1 Using Keys ................................................................................................................ 17
3.3 Operating Mode ................................................................................................................... 18
3.3.1 Demo Mode............................................................................................................... 18
3.3.2 Standby Mode ........................................................................................................... 19
3.4 Changing Monitor Settings .................................................................................................. 19
3.4.1 Adjusting Screen Brightness ..................................................................................... 19
3.4.2 Changing Date and Time........................................................................................... 19
3.5 Adjusting Volume ................................................................................................................. 20
3.5.1 Adjusting Key Volume .............................................................................................. 20
3.5.2 Adjusting Alarm Volume ........................................................................................... 20
3.5.3 Adjusting Beat Volume.............................................................................................. 20
3.6 Checking Your Monitor Version .......................................................................................... 20
3.7 Networked Monitoring ......................................................................................................... 20
3.8 Setting Languages ................................................................................................................ 20
3.9 Understanding Screens ......................................................................................................... 21
3.10 Calibrating Screens ............................................................................................................ 21
3.11 Disabling the TouchScreen ................................................................................................. 21
3.12 Using the Barcode Scanner ................................................................................................ 21
Chapter 4 Alarms ............................................................................................................................. 22
III
4.1 Alarm Category .................................................................................................................... 22
4.1.1 Physiological alarms ................................................................................................. 22
4.1.2 Technical Alarms ....................................................................................................... 22
4.1.3 Prompts ..................................................................................................................... 22
4.2 Alarm Levels ........................................................................................................................ 22
4.3 Controlling Alarm ................................................................................................................ 23
4.3.1 Switching the Individual Alarm Off .......................................................................... 23
4.3.2 Temporary Alarm Mute ............................................................................................. 23
4.3.3 Alarm Mute ............................................................................................................... 24
4.3.4 Controlling Alarm Volume ........................................................................................ 24
4.3.5 Setting Alarm Limits ................................................................................................. 24
4.4 Latching Alarms ................................................................................................................... 25
4.5 Disabling Sensor Off Alarms ............................................................................................... 25
4.6 Testing Alarms...................................................................................................................... 25
Chapter 5 Alarm Information ......................................................................................................... 26
5.1 Physiological Alarm Information ......................................................................................... 26
5.2 Technical Alarm Information ............................................................................................... 30
5.3 Prompts ................................................................................................................................ 41
5.4 Adjustable Range of Alarm Limits ....................................................................................... 42
Chapter 6 Managing Patients ......................................................................................................... 47
6.1 Admitting a Patient ............................................................................................................... 47
6.1.1 Patient Category and Paced Status ............................................................................ 47
6.2 Quick Admit ......................................................................................................................... 48
6.3 Editing Patient Information .................................................................................................. 48
6.4 Updating a Patient ................................................................................................................ 48
6.5 Central Monitoring System .................................................................................................. 48
Chapter 7 User Interface ................................................................................................................. 49
7.1 Setting Interface Style .......................................................................................................... 49
7.2 Selecting Display Parameters ............................................................................................... 49
7.3 Changing Waveform Position .............................................................................................. 49
7.4 Changing Interface Layout ................................................................................................... 49
7.5 Viewing Trend Screen .......................................................................................................... 49
7.6 Viewing Oxygen Screen ....................................................................................................... 49
7.7 Viewing Large Font Screen .................................................................................................. 50
7.8 Changing Parameter and Waveform Colors ......................................................................... 50
7.9 Transferring a Configuration ................................................................................................ 50
7.10 Default Configuration ........................................................................................................ 51
Chapter 8 Monitoring ECG ............................................................................................................ 52
8.1 Overview .............................................................................................................................. 52
IV
8.2 ECG Safety Information ...................................................................................................... 52
8.3 ECG Display ........................................................................................................................ 53
8.3.1 Changing the Size of the ECG Wave ........................................................................ 53
8.3.2 Changing the ECG Filter Settings ............................................................................. 54
8.4 Using ECG Alarms ............................................................................................................... 54
8.5 Selecting Calculation Lead .................................................................................................. 54
8.6 Monitoring Procedure .......................................................................................................... 54
8.6.1 Preparation ................................................................................................................ 54
8.6.2 Connecting ECG Cables ........................................................................................... 55
8.7 Selecting Lead Type ............................................................................................................. 55
8.8 Installing Electrodes ............................................................................................................. 55
8.8.1 Electrode Placement for 3-lead ................................................................................. 56
8.8.2 Electrode Placement for 5-lead ................................................................................. 56
8.8.3 Electrode Placement for 12-lead ............................................................................... 58
8.8.4 Recommended ECG Lead Placement for Surgical Patients ..................................... 59
8.9 ECG Menu Setup ................................................................................................................. 60
8.9.1 Setting Alarm Source ................................................................................................ 60
8.9.2 Smart Lead Off .......................................................................................................... 60
8.9.3 Setting Beat Volume .................................................................................................. 60
8.9.4 ECG Display ............................................................................................................. 60
8.9.5 Setting Pace Status .................................................................................................... 61
8.9.6 ECG Calibration ........................................................................................................ 61
8.9.7 ECG Waveform Settings ........................................................................................... 61
8.9.8 12 Leads ECG ........................................................................................................... 61
8.10 ST Segment Monitoring ..................................................................................................... 62
8.10.1 Setting ST Analysis ................................................................................................. 62
8.10.2 ST Display............................................................................................................... 62
8.10.3 ST Analysis Alarm Setting ...................................................................................... 62
8.10.4 About ST Measurement Points................................................................................ 62
8.10.5 Adjusting ST and ISO Measurement Points............................................................ 63
8.11 Arr. Monitoring................................................................................................................... 63
8.11.1 Arrhythmia Analysis ................................................................................................ 63
8.11.2 ARR Analysis Menu ................................................................................................ 64
8.12 12-Lead ECG Monitoring .................................................................................................. 65
8.12.1 Diagnosis Function ................................................................................................. 65
8.12.2 Measurement and Interpretation ............................................................................. 66
Chapter 9 Monitoring RESP ........................................................................................................... 67
9.1 Overview .............................................................................................................................. 67
9.2 RESP Safety Information ..................................................................................................... 67
V
9.3 Resp Display ........................................................................................................................ 67
9.4 Electrode Placement for Monitoring Resp ........................................................................... 68
9.5 Cardiac Overlay ................................................................................................................... 68
9.6 Chest Expansion ................................................................................................................... 68
9.7 Abdominal Breathing ........................................................................................................... 68
9.8 Selecting Resp Lead ............................................................................................................. 68
9.9 Changing Hold Type ............................................................................................................ 69
9.10 Changing the Size of the Respiration Wave ....................................................................... 69
9.11 Using Resp Alarms ............................................................................................................. 69
9.12 Changing the Apnea Time .................................................................................................. 69
Chapter 10 Monitoring SpO2 .......................................................................................................... 70
10.1 Overview ............................................................................................................................ 70
10.2 SpO2 Safety Information .................................................................................................... 70
10.3 Measuring SpO2 ................................................................................................................. 71
10.4 Measurement Procedure ..................................................................................................... 71
10.5 Understanding SpO2 Alarms .............................................................................................. 72
10.6 Adjusting Alarm Limits ...................................................................................................... 72
10.7 Setting SpO2 as Pulse Source ............................................................................................. 72
10.8 Setting Pitch Tone .............................................................................................................. 72
10.9 Setting Sensitivity .............................................................................................................. 72
Chapter 11 Monitoring PR .............................................................................................................. 73
11.1 Overview ............................................................................................................................ 73
11.2 Setting PR Source............................................................................................................... 73
11.3 Setting PR Volume ............................................................................................................. 73
11.4 Using Pulse Alarms ............................................................................................................ 73
11.5 Selecting the Active Alarm Source..................................................................................... 73
Chapter 12 Monitoring NIBP ......................................................................................................... 74
12.1 Overview ............................................................................................................................ 74
12.2 NIBP Safety Information ................................................................................................... 74
12.3 Introducing the Oscillometric NIBP Measurement ............................................................ 75
12.4 Measurement Limitations .................................................................................................. 75
12.5 Measurement Methods ....................................................................................................... 75
12.6 Measurement Procedures ................................................................................................... 76
12.7 Operation Prompts ............................................................................................................. 77
12.8 Correcting the Measurement if Limb is not at Heart Level ............................................... 78
12.9 NIBP Alarm ........................................................................................................................ 78
12.10 Resetting NIBP ................................................................................................................ 78
12.11 Calibrating NIBP .............................................................................................................. 78
12.12 Leak Test .......................................................................................................................... 78
VI
12.12.1 Procedure of Leak Test .......................................................................................... 78
Chapter 13 Monitoring TEMP........................................................................................................ 80
13.1 Overview ............................................................................................................................ 80
13.2 TEMP Safety Information .................................................................................................. 80
13.3 TEMP Monitoring Setup .................................................................................................... 80
13.4 Calculating Temp Difference ............................................................................................. 80
Chapter 14 Monitoring Quick TEMP ............................................................................................ 81
14.1 Overview ............................................................................................................................ 81
14.2 Quick TEMP Safety Information ....................................................................................... 81
14.3 Measuring Procedure ......................................................................................................... 82
14.3.1 Measurement for Oral Temperature ........................................................................ 82
14.3.2 Measurements for Rectal Temperatures .................................................................. 83
14.3.3 Measurements for Axillary Temperatures ............................................................... 83
14.4 Changing Temp Unit .......................................................................................................... 84
Chapter 15 Monitoring IBP ............................................................................................................ 85
15.1 Overview ............................................................................................................................ 85
15.2 IBP Safety Information ...................................................................................................... 85
15.3 Monitoring Procedures ....................................................................................................... 85
15.4 Selecting a Pressure for Monitoring ................................................................................... 86
15.5 Zeroing the Pressure Transducer ........................................................................................ 86
15.6 Zeroing a Pressure Measurement ....................................................................................... 86
15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example) ...................................... 87
15.8 IBP Pressure Calibration .................................................................................................... 87
15.9 Troubleshooting the Pressure Calibration .......................................................................... 88
15.10 IBP Alarm ......................................................................................................................... 88
Chapter 16 Monitoring CO2 ............................................................................................................ 89
16.1 Overview ............................................................................................................................ 89
16.2 CO2 Safety Information ..................................................................................................... 89
16.3 Monitoring Procedures ....................................................................................................... 90
16.3.1 Zeroing the sensor ................................................................................................... 90
16.3.2 LoFlo CO2 Module.................................................................................................. 90
16.3.3 C5 CO2 Module ....................................................................................................... 92
16.4 Setting CO2 Waveform Setup ............................................................................................. 94
16.5 Setting CO2 Corrections ..................................................................................................... 94
16.6 Changing CO2 Alarms ........................................................................................................ 94
16.7 Changing Apnea Alarm ...................................................................................................... 94
Chapter 17 Monitoring C.O. ........................................................................................................... 96
17.1 Overview ............................................................................................................................ 96
17.2 C.O. Safety Information ..................................................................................................... 96
VII
17.3 C.O. Monitoring Procedures .............................................................................................. 96
17.4 C.O. Measurement Window ............................................................................................... 97
17.5 Measurement Process ......................................................................................................... 99
17.6 Editing C.O. ....................................................................................................................... 99
17.7 Blood Temperature Monitoring........................................................................................ 100
17.8 Setting the Computation Constant ................................................................................... 101
17.9 Recording C.O. Measurements ........................................................................................ 101
17.10 Setting INJ. TEMPSource .............................................................................................. 101
Chapter 18 Monitoring AG ........................................................................................................... 102
18.1 Overview .......................................................................................................................... 102
18.2 Safety Information ........................................................................................................... 102
18.2.1 Safety Information for ISA Analyzer .................................................................... 102
18.2.2 Safety Information for IRMA Module .................................................................. 104
18.3 Monitoring Steps .............................................................................................................. 105
18.3.1 Monitoring Steps for ISA Analyzer....................................................................... 105
18.3.2 Monitoring Steps for IRMA Module..................................................................... 107
18.4 Setting Work Mode .......................................................................................................... 110
18.5 Setting Alarms .................................................................................................................. 111
18.6 Setting Apnea Alarm Time ............................................................................................... 111
18.7 Working Status of ISA analyzer ....................................................................................... 111
18.8 Working Status of IRMA Module .................................................................................... 111
18.9 N2O and O2 Compensations ............................................................................................. 111
18.10 Effects of humidity ......................................................................................................... 112
Chapter 19 Freeze .......................................................................................................................... 113
19.1 Overview .......................................................................................................................... 113
19.2 Entering/Exiting Freeze Status ......................................................................................... 113
19.2.1 Entering Freeze Status........................................................................................... 113
19.2.2 Exiting Freeze Status............................................................................................. 113
19.3 Reviewing Frozen Waveform........................................................................................... 114
Chapter 20 Review ......................................................................................................................... 115
20.1 Trend Graph Review ........................................................................................................ 115
20.1.1 Selecting Trend Graph of Specific Parameter ....................................................... 115
20.1.2 Setting Resolution ................................................................................................. 115
20.1.3 Scrolling Left and Right the Screen ...................................................................... 115
20.1.4 Switching to the Trend Table ................................................................................ 116
20.1.5 Record ................................................................................................................... 116
20.2 Trend Table Review ......................................................................................................... 116
20.2.1 Setting Resolution ................................................................................................. 116
20.2.2 Scrolling the Screen .............................................................................................. 116
VIII
20.2.3 Switching to Trend Graph ..................................................................................... 116
20.2.4 Recording .............................................................................................................. 116
20.3 NIBP Review.................................................................................................................... 116
20.3.1 Scrolling the Screen .............................................................................................. 117
20.3.2 Recording .............................................................................................................. 117
20.4 Alarm Review................................................................................................................... 117
20.4.1 Scrolling the Screen .............................................................................................. 117
20.4.2 Selecting Alarm Event of Specific Parameter ....................................................... 117
20.4.3 Setting Time Index ................................................................................................ 117
20.5 Arr Review ....................................................................................................................... 117
20.5.1 Scrolling the Screen .............................................................................................. 117
20.6 12-lead Diagnosis Review ............................................................................................... 118
20.6.1 Scrolling the Screen .............................................................................................. 118
20.6.2 Deleting Diagnosis Results ................................................................................... 118
20.6.3 Switching Between Waveforms and Results ......................................................... 118
20.6.4 Recording .............................................................................................................. 118
Chapter 21 Calculation and Titration Table................................................................................ 119
21.1 Drug Calculation .............................................................................................................. 119
21.1.1 Calculation Procedures ......................................................................................... 119
21.1.2 Calculation Unit .................................................................................................... 120
21.2 Titration Table .................................................................................................................. 120
Chapter 22 Recording .................................................................................................................... 121
22.1 General Information ......................................................................................................... 121
22.2 Performance of the Recorder ........................................................................................... 121
22.3 Recording Type ................................................................................................................ 122
22.4 Starting and Stopping Recording ..................................................................................... 122
22.5 Recorder Operations and Status Messages ...................................................................... 123
22.5.1 Record Paper Requirement ................................................................................... 123
22.5.2 Proper Operation ................................................................................................... 123
22.5.3 Paper Out ............................................................................................................... 123
22.5.4 Replacing Paper .................................................................................................... 123
22.5.5 Removing Paper Jam............................................................................................. 124
Chapter 23 Other Functions.......................................................................................................... 126
23.1 Nurse Call ........................................................................................................................ 126
Chapter 24 Using Battery .............................................................................................................. 127
24.1 Battery Power Indicator ................................................................................................... 127
24.2 Battery Status on the Main Screen ................................................................................... 127
24.3 Checking Battery Performance ........................................................................................ 127
24.4 Replacing the Battery ....................................................................................................... 128
IX
24.5 Recycling the Battery ....................................................................................................... 129
24.6 Maintaining the Battery.................................................................................................... 129
Chapter 25 Care and Cleaning ..................................................................................................... 130
25.1 General Points .................................................................................................................. 130
25.2 Cleaning ........................................................................................................................... 130
25.2.1 Cleaning the Monitor ............................................................................................ 130
25.2.2 Cleaning the Accessories....................................................................................... 131
25.3 Disinfection ...................................................................................................................... 133
Chapter 26 Maintenance ............................................................................................................... 134
26.1 Inspecting ......................................................................................................................... 134
26.2 Maintenance Task and Test Schedule ............................................................................... 134
Chapter 27 Warranty and Service ................................................................................................ 136
27.1 Warranty ........................................................................................................................... 136
27.2 Contact information ......................................................................................................... 136
Chapter 28 Accessories .................................................................................................................. 137
28.1 ECG Accessories .............................................................................................................. 137
28.2 SpO2 Accessories ............................................................................................................. 138
28.3 NIBP Accessories ............................................................................................................. 139
28.4 Temp Accessories ............................................................................................................. 140
28.5 Quick Temp Accessories .................................................................................................. 140
28.6 IBP Accessories ................................................................................................................ 140
28.7 CO2 Accessories ............................................................................................................... 140
28.8 C.O. Accessories .............................................................................................................. 141
28.9 AG Accessories ................................................................................................................ 141
28.10 Other Accessories ........................................................................................................... 142
A Product Specification ................................................................................................................. 143
A.1 Classification ..................................................................................................................... 143
A.2 Physical Specifications...................................................................................................... 143
A.2.1 Size and Weight ...................................................................................................... 143
A.3 Environment Specification ................................................................................................ 143
A.4 Display .............................................................................................................................. 144
A.5 Battery Specification ......................................................................................................... 144
A.6 Recorder ............................................................................................................................ 145
A.7 Review............................................................................................................................... 145
A.8 ECG ................................................................................................................................... 145
A.8.1 3, 5-lead Monitoring............................................................................................... 145
A.8.2 12-lead Monitoring................................................................................................. 149
A.9 RESP ................................................................................................................................. 154
A.10 NIBP ................................................................................................................................ 154
X
A.10.1 NIBP from EDAN Module................................................................................... 154
A.10.2 NIBP from M3600 Module .................................................................................. 155
A.11 SpO2................................................................................................................................. 156
A.11.1 SpO2 from EDAN Module ................................................................................... 156
A.11.2 SpO2 from Nellcor Module .................................................................................. 157
A.12 TEMP .............................................................................................................................. 157
A.13 Quick TEMP ................................................................................................................... 158
A.14 IBP ................................................................................................................................... 158
A.15 CO2 .................................................................................................................................. 158
A.16 C.O. ................................................................................................................................. 160
A.17 AG ................................................................................................................................... 161
A.17.1 Phasein Sidestream............................................................................................... 161
A.17.2 Phasein Mainstream ............................................................................................. 163
A.18 Wirless Network .............................................................................................................. 166
B EMC Information ....................................................................................................................... 167
B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS................................. 167
B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ................................. 167
B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING................................................................................................................ 168
B.4 Recommended Separation Distances ................................................................................ 170
C Default Settings........................................................................................................................... 171
C.1 Patient Information Default Settings ................................................................................. 171
C.2 Alarm Default Settings ...................................................................................................... 171
C.3 ECG Default Settings ........................................................................................................ 171
C.4 RESP ................................................................................................................................. 172
C.5 SpO2................................................................................................................................... 173
C.6 PR ...................................................................................................................................... 173
C.7 NIBP .................................................................................................................................. 173
C.8 TEMP ................................................................................................................................ 174
C.9 Quick TEMP ...................................................................................................................... 174
C.10 IBP ................................................................................................................................... 175
C.11 CO2 .................................................................................................................................. 175
C.12 C.O. ................................................................................................................................. 176
C.13 AG ................................................................................................................................... 176
D Abbreviations .............................................................................................................................. 178
XI
Patient Monitor User Manual Indication for Use and Safety Guidance
-1-
Patient Monitor User Manual Indication for Use and Safety Guidance
WARNING
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 patients 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 can not be guaranteed, and the patient
may be injuried.
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 childrens 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.
-2-
Patient Monitor User Manual Indication for Use and Safety Guidance
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.
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 5C and
40C while working. And it should be kept between -20C and 55C during
transportation and storage.
9 To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
10 Federal 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.
-3-
Patient Monitor User Manual Indication for Use and Safety Guidance
Alternating Current
Serial number
Network port
NIBP measurement
Trend graph
Freeze
Record
-4-
Patient Monitor User Manual Indication for Use and Safety Guidance
Menu
RS-232 port
SD Card port
Signal output
The symbol indicates that the device complies with the European
Council Directive 93/42/EEC concerning medical devices.
Date of manufacture
Manufacturer
Recycle
-5-
Patient Monitor User Manual Indication for Use and Safety Guidance
The symbol indicates that the device should be sent to the special
agencies according to local regulations for separate collection after its
useful life.
Locked position
Gas inlet
-6-
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.
-7-
Patient Monitor User Manual Installation
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 monitors
steady performance and long lifespan.
-8-
Patient Monitor User Manual Basic Operation
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
-9-
Patient Monitor User Manual Basic Operation
- 10 -
Patient Monitor User Manual Basic Operation
1 Fan
2 Anti-theft lock interface
3 Security Lock
4 Power Supply Inlet
5 USB Interface
6 VGA Interface
7 Network Interface
8 Defibrillator Synchronization/ Analog Output
9 SD Card
10 Speaker
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.
- 11 -
Patient Monitor User Manual Basic Operation
1 Sensor interface
2 Recorder door
3 Battery door
1 Alarm indicator when an alarm occurs, the alarm indicator will light
- 12 -
Patient Monitor User Manual Basic Operation
- 13 -
Patient Monitor User Manual Basic Operation
1 3
4
2
1 Sensor port
2 AG fixation bracket
3 Recorder door
4 Battery door
1
13
2
3
4 12
5
11
6 7 8 9 10
- 14 -
Patient Monitor User Manual Basic Operation
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 auxillary output port. When the user selects
Defibrillator, the monitor outputs the defibrillator
synchronization signal through the auxillary output port.
4 VGA output
5 USB interface, this port is used to connect the USB device.
6 RS232 interface
7 Network interface, this port is used to connect to the central
monitoring system through the standard network wire.
8 Anti-theft lock interface
9 Heat emission hole
10 Security lock, used to prevent the power supply cord from falling.
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
- 15 -
Patient Monitor User Manual Basic Operation
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.
1 Department
2 Bed number
3 Patient name
4 Patient type
5 Alarm status area
6 Alarm off
7 Measurement value
8 Menu
9 Scroll right to display more shortcut keys
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Patient Monitor User Manual Basic Operation
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.
Directly select this item on the screen to quickly admit a patient
Directly select this item on the screen to enter trend graph review
interface
Directly select this item on the screen to enter trend table review interface
Directly select this item on the screen to enter the alarm event review
interface
Directly select this item on the screen to enter the NIBP review interface
Directly select this item on the screen to enter the ARR review interface
- 17 -
Patient Monitor User Manual Basic Operation
Directly select this item on the screen to enter the TrendScreen interface
Directly select this item on the screen to enter the standard interface
Directly select this item on the screen to enter the OxyCRG interface
Directly select this item on the screen to enter the Large Font interface
Directly select this item on the screen to enter the module switch interface
Directly select this item on the screen to change the key volume
Directly select this item on the screen to adjust the screen brightness
Directly select this item on the screen to calibrate the touch screen
Directly select this item on the screen to zero the IBP sensor
Directly select this item on the screen to enter the alarm setup interface
Directly select this item on the screen to change the beat volume
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.
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Patient Monitor User Manual Basic Operation
2. 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:
Storing no data of new patient.
Pausing to give all types of alarm.
Pausing to transmit patient data to CMS and other network devices.
Pausing to store the currently recorded data, and clearing the memory used to store
recording and printing data.
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.
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 monitors
memory.
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Patient Monitor User Manual Basic Operation
WARNING
Change to date and time will influence the storage of trend data.
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Patient Monitor User Manual Basic Operation
- 21 -
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.
4.1.3 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.
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Patient Monitor User Manual Alarms
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 5 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 85 dB.
and set Switch to Off from the popup list. Alarm Off symbol is displayed on the parameter
area if the parameter alarm is switched to off.
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Patient Monitor User Manual Alarms
The user can set the audio alarm pause to 60 s, 120 s, or 180 s based on the requirement.
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.
To change individual measurement alarm limits, take HR alarm for example, please refer to the
following steps:
1. Select the HR Parameter area.
2. Select HR Setup > Alarm Setup. Then set the alarm limit to the desired value from the
popup interface. For how to set the alarm limit, please refer to the following figure:
Setting value of
high alarm limit
- 24 -
Patient Monitor User Manual Alarms
- 25 -
Patient Monitor User Manual Alarm Information
- 26 -
Patient Monitor User Manual Alarm Information
- 27 -
Patient Monitor User Manual Alarm Information
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
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
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Patient Monitor User Manual Alarm Information
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 a specific time interval, no RESP can be detected
CO2 APNEA High
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
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
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
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
- 29 -
Patient Monitor User Manual Alarm Information
FiDES Low FiDES measuring value is below lower alarm limit. User-selectable
AG FiO2 Low FiO2 measurement value is too low. High
In a specific time interval, no RESP can be detected
AG APNEA High
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
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.
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Patient Monitor User Manual Alarm Information
Stop measuring
function of ECG
ECG module failure or module, and notify
ECG Comm Fail High
communication failure biomedical engineer
or manufacturers
service staff.
Check lead
ECG measuring signal is
ECG Noise Low connection and
greatly interrupted.
patient condition
Stop measuring
function of RESP
RESP module failure or module, and notify
RESP Comm Fail High
communication failure biomedical engineer
or the manufacturers
service staff.
- 31 -
Patient Monitor User Manual Alarm Information
Measure again, if
failure persists, stop
measuring function
NIBP Excessive Pressure has exceeded the of NIBP module and
Low
Pressure specified upper safety limit. notify biomedical
engineer or
manufacturers
service staff.
- 32 -
Patient Monitor User Manual Alarm Information
Measure again, if
failure persists, stop
measuring function
NIBP Init Pressure The initial pressure is too of NIBP module and
High
High high during measuring notify biomedical
engineer or
manufacturers
service staff.
Measure again, if
failure persists, stop
using measuring
The hardware pressure is function of NIBP
NIBP Invalid Reset Low
too high module and notify
biomedical engineer
or manufacturers
service staff.
- 33 -
Patient Monitor User Manual Alarm Information
- 34 -
Patient Monitor User Manual Alarm Information
Check sensor
TEMP1 measuring value is
Excessive T1 High connection and
beyond measuring range.
patient condition
Check sensor
TEMP2 measuring value is
Excessive T2 High connection and
beyond measuring range.
patient condition
Stop measuring
function of TEMP
TEMP module failure or module, and notify
TEMP Comm Fail High
communication failure. biomedical engineer
or Manufacturers
service staff.
Stop measuring
function of IBP
YY Comm Fail (YY
IBP module failure or module, and notify
stands for the label High
communication failure biomedical engineer
name)
or Manufacturers
service staff.
- 35 -
Patient Monitor User Manual Alarm Information
Stop measuring of
C.O. module, or
C.O. module failure or notify biomedical
C.O. Comm Fail High
communication failure engineer or
Manufacturers
service staff.
C.O. TI sensor not Insert injectate
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.
C.O. measuring needs Please input patients
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.
Manufacturers
service staff.
Stop measuring
function of AG
AG module failure or module, and notify
AG Comm Fail High
communication failure. biomedical engineer
or Manufacturers
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.
O2 sensor needs to be Please replace the O2
AG Replace O2 Sensor High
replaced. sensor.
Please wait check
AG Check Adapter AG module checks adapter. Low
finishing.
- 36 -
Patient Monitor User Manual Alarm Information
- 37 -
Patient Monitor User Manual Alarm Information
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.
AG module detects mixture Close the subsidiary
AG Mixed Agents Medium
gas agent. gas agent.
CO2 Ram Error CO2 module failure High Stop using CO2 alarm
function, and notify
biomedical engineer
or Manufacturers
CO2 Rom Error CO2 module failure High service staff.
- 38 -
Patient Monitor User Manual Alarm Information
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.
Manufacturers
service staff.
Stop measuring
function of TEMP
QuickTemp Comm TEMP module failure or module, and notify
High
Fail communication failure. biomedical engineer
or manufacturers
service staff.
Put the sensor into
The TEMP value is beyond
the sensor bracket,
Temp exceed limit the range of +25C ~ Med
take it out and
+45C.
measure again.
- 39 -
Patient Monitor User Manual Alarm Information
- 40 -
Patient Monitor User Manual Alarm Information
5.3 Prompts
Message Cause
- 41 -
Patient Monitor User Manual Alarm Information
- 42 -
Patient Monitor User Manual Alarm Information
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)
Patient Type ALM HI ALM LO
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 (M3600 module): unit (mmHg)
Patient Type ALM HI ALM LO
SYS 250 60
ADU(PED) DIA 200 40
MAP 235 45
SYS 120 40
NEO DIA 90 20
MAP 100 30
TEMP alarm limits are listed as follows:
ALM HI ALM LO
T1 50C (122 F) 0C (32 F)
T2 50C (122 F) 0C (32 F)
TD 50C (90 F) 0C (0 F)
- 43 -
Patient Monitor User Manual Alarm Information
- 44 -
Patient Monitor User Manual Alarm Information
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%
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%
- 45 -
Patient Monitor User Manual Alarm Information
- 46 -
Patient Monitor User Manual Managing Patients
- 47 -
Patient Monitor User Manual Managing Patients
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.
- 48 -
Patient Monitor User Manual User Interface
- 49 -
Patient Monitor User Manual User Interface
- 50 -
Patient Monitor User Manual User Interface
- 51 -
Patient Monitor User Manual Monitoring ECG
NOTE:
1 Interference from a non-grounded instrument near the patient and ESU interference
can cause inaccuracy of the waveform.
- 52 -
Patient Monitor User Manual Monitoring ECG
The symbol 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 indicates waveform gain: there are several options, sucn as X0.125, X0.25,
X0.5, X1, X2 and Auto. If you want to change it, please refer to section Changing the size of the
ECG Wave.
The symbol indicates Filter setting, there are three options: monitoring, surgery, diagnos. If
you want to change it, please refer to section Changing the ECG Filter Setting.
- 53 -
Patient Monitor User Manual Monitoring ECG
- 54 -
Patient Monitor User Manual Monitoring ECG
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.
- 55 -
Patient Monitor User Manual Monitoring ECG
- 56 -
Patient Monitor User Manual Monitoring ECG
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.
- 57 -
Patient Monitor User Manual Monitoring ECG
- 58 -
Patient Monitor User Manual Monitoring ECG
Monitoring ECG leads are mainly used for monitoring the patients 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.
- 59 -
Patient Monitor User Manual Monitoring ECG
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.
- 60 -
Patient Monitor User Manual Monitoring ECG
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.
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.
NOTE:
The device cant be monitored during ECG calibration.
- 61 -
Patient Monitor User Manual Monitoring ECG
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.
8.10.2 ST Display
Your monitor screen may be configured to look slightly different from the illustrations.
NOTE:
1 ST Analysis only can be used only in Adu mode.
2 When setting ST Analysis to on, the monitor should be in Diagnos mode.
3 ECG monitoring should be in Diagnos mode.
- 62 -
Patient Monitor User Manual Monitoring ECG
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.
- 63 -
Patient Monitor User Manual Monitoring ECG
- 64 -
Patient Monitor User Manual Monitoring ECG
WARNING
When the PVCs Alarm is set to OFF, the monitor wont give an alarm prompt even if an
alarm occurs. In order to avoid endangering the patients life, the user should use this
function cautiously.
- 65 -
Patient Monitor User Manual Monitoring ECG
Figure a
Figure b
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.
- 66 -
Patient Monitor User Manual Monitoring RESP
NOTE:
The RESP monitoring is not recommended to be used on patients who are very active, as
this can cause false alarms.
14
- 67 -
Patient Monitor User Manual Monitoring RESP
- 68 -
Patient Monitor User Manual Monitoring RESP
- 69 -
Patient Monitor User Manual Monitoring SpO2
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.
- 70 -
Patient Monitor User Manual Monitoring SpO2
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.
- 71 -
Patient Monitor User Manual Monitoring SpO2
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.
- 72 -
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.
- 73 -
Patient Monitor User Manual Monitoring NIBP
- 74 -
Patient Monitor User Manual Monitoring NIBP
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 an alarm occurs or measurement fails, please discontinue the measurement.
3 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.
4 Continuous use of the automatic measuring mode for short intervals may lead to the
discomfort of patient.
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.
NOTE:
The width of the cuff should be either 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.
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Patient Monitor User Manual Monitoring NIBP
Cuff Usage
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.
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
- 77 -
Patient Monitor User Manual Monitoring NIBP
continuous measurement.
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.
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Patient Monitor User Manual Monitoring NIBP
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.
If the prompt of Leak Test OK appears, it indicates that the airway is in good situation
and no air leaks exist. However if the alarm information of NIBP Cuff 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.
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Patient Monitor User Manual Monitoring TEMP
NOTE:
Disposable TEMP probe can only be used once for one patient.
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Patient Monitor User Manual Monitoring Quick TEMP
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.
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 patients 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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Patient Monitor User Manual Monitoring Quick TEMP
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 isnt suitable for use during defibrillation.
Sublingual Pocket
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.
NOTE:
1 After one measurement, the user should put the sensor well to the sensor bracket
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Patient Monitor User Manual Monitoring Quick TEMP
WARNING
Incorrect insertion can cause bowel perforation.
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Patient Monitor User Manual Monitoring Quick TEMP
NOTE:
Do not take an axilliary temperature through the patients clothing. Direct contact
between the patients skin and the probe is required.
To obtain accurate rectal temperature, use the white temperature probe.
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Patient Monitor User Manual Monitoring IBP
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.
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Patient Monitor User Manual Monitoring IBP
WARNING
If there are air bubbles in the pressure line or the transducer, you should flush the system
with the solution to be infused.
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
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Patient Monitor User Manual Monitoring IBP
4. When you see the message Zero Ok, please close the stopcock to atmospheric pressure, and
open the stopcock to the patient.
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Patient Monitor User Manual Monitoring IBP
2 5
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Patient Monitor User Manual Monitoring CO2
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Patient Monitor User Manual Monitoring CO2
NOTE:
After the low battery alarm appears, please do not start the CO2 measurement, or the
monitor may turn off for the low battery.
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Patient Monitor User Manual Monitoring CO2
for warm-up.
2 Connect the cannula, airway adapter, or sample line as appropriate, to the sensor. It will
click into place when seated correctly.
Air adapter
For non-intubated patients: Place the nasal cannula onto the patient.
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Patient Monitor User Manual Monitoring CO2
NOTE:
1 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.
2 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.
C5 CO2 module
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Patient Monitor User Manual Monitoring CO2
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.
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.
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
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Patient Monitor User Manual Monitoring CO2
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.
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Patient Monitor User Manual Monitoring CO2
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.
NOTE:
To replace the catheter thermistor, please enter the catheter computation coefficient into
the Constant item according to the instruction.
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Patient Monitor User Manual Monitoring C.O.
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.
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Patient Monitor User Manual Monitoring C.O.
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Patient Monitor User Manual Monitoring C.O.
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 can not 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.
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
patients 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.
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Patient Monitor User Manual Monitoring C.O.
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.
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Patient Monitor User Manual Monitoring C.O.
Right ventricle
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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 molude (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.
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Patient Monitor User Manual Monitoring AG
WARNING
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 occulsion 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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Patient Monitor User Manual Monitoring AG
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.
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Patient Monitor User Manual Monitoring AG
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.
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Patient Monitor User Manual Monitoring AG
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.
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Patient Monitor User Manual Monitoring AG
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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Patient Monitor User Manual Monitoring AG
5 Connect the IRMA/airway adapter 15mm female connector to the patients endotracheal
tube.
Alternatively, connect an HME (Heat Moisture Exchanger) between the patients 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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Patient Monitor User Manual Monitoring AG
WARNING
The IRMA probe is not intended to be in long term skin contact.
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
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Patient Monitor User Manual Monitoring AG
adapter is of crucial importance for a successful zeroing. If a ZERO-REQ alarm should appear
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.
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Patient Monitor User Manual Monitoring AG
- 111 -
Patient Monitor User Manual Monitoring AG
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.
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.
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, 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.
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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.
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Patient Monitor User Manual Review
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 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.
20.2.4 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.
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Patient Monitor User Manual Review
Menu > Review > NIBP Review, then the NIBP Review window is displayed.
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.
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Patient Monitor User Manual Review
in the current view by selecting and pressing the symbol and displayed on the
Arrhythmia Review interface.
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
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.
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Patient Monitor User Manual Calculation and Titration Table
NOTE:
1 The drug calculation is displayed as invalid value before the user edits the drug name
and patient weight, and the user cant enter any value.
2 Drip Rate and Drop Size are invalid in the neonatal mode.
Scroll up and down the screen by selecting and pressing the symbol and displayed
on the trend graph.
Record the data displayed in the current window by selecting Record.
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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.
2
1
1 Recording indicator
2 Recording key, press this key to start or stop recording task.
3 Paper outlet
4 Recorder Door
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Patient Monitor User Manual Recording
- 122 -
Patient Monitor User Manual Recording
NOTE:
You can press the button on the front panel to stop the currently recording process.
2. Insert a new roll of paper into the paper cassette, printing side facing upwards.
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Patient Monitor User Manual Recording
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.
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Patient Monitor User Manual Recording
NOTE:
1. If the monitor is not installed with a recorder, it will indicate RECORDER SETUP
NEEDED after pressing the Record button.
2. Do not touch the thermo-sensitive print head when performing continuous recording.
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Patient Monitor User Manual Other Functions
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Patient Monitor User Manual Using Battery
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
no electric energy in the battery. When there isnt enough electric energy, a sign is
displayed on the screen.
When the montor is battery powered, the monitor switches off antomatically if there is no power.
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.
3 Do not unplug the battery when monitoring.
4 Do not heat or throw battery into a fire.
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Patient Monitor User Manual Using Battery
WARNING
5 Do not use, leave battery close to fire or other places where temperature may be
above 60C.
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.
Battery Door
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Patient Monitor User Manual Using Battery
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.
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Patient Monitor User Manual Care and Cleaning
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.
WARNING
1 Unplug the monitor from the AC power source and detach all accessories before
cleaning. Do not immerse the unit in water or allow liquids to enter the case.
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Patient Monitor User Manual Care and Cleaning
2 If liquid is splashed on or into the main unit inadvertently, or enters the conduit, stop
using the monitor and contact the manufacturer for service immediately.
Clean the monitor enclosure with soft cloth and diluent non-caustic detergents recommended
above.
Clean the screen with a dry soft cloth.
Clean the touch screen with a soft cloth and neutral detergent or isopropyl alcohol. Do not use
chemical solvents, acidic or alkali solutions.
CAUTION
1 Although the monitor is chemically resistant to most common hospital cleaners and
non-caustic detergents, different cleaners are not recommended and may stain the
monitor.
2 Many cleansers must be diluted before use. Follow the manufacturers directions
carefully to avoid damaging the monitor.
3 Dont use strong solvent, for example, acetone.
4 Never use an abrasive such as steel wool or metal polish.
5 Do not allow any liquid to enter the product, and do not immerse any part of the
monitor into any liquid.
6 Avoid pouring liquids on the monitor while cleaning.
7 Dont remain any cleaning solution on the surface of the monitor.
NOTE:
1 The monitor surface can be cleaned with hospital-grade ethanol and dried in air or
with crisp and clean cloth.
2 The manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in
your hospital for details.
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Patient Monitor User Manual Care and Cleaning
CAUTION
Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface.
After allowing the appropriate time for the agent to work (as indicated by the
manufacturer), wipe off residues with a cloth dampened with water.
Clean with a lint-free cloth, moistened with warm water (40/104) and substances listed
below. Never use strong solvents such as acetone or trichloroethylene.
Approved Cleaning Substances
Mild Soaps
Tenside (as active cleaning agent)
Cables and leadwires can be cleaned with a warm, damp cloth and mild soap, or isopropyl
alcohol.
25.2.2.2 Cleaning the Blood Pressure Cuff
Wipe cuffs with a solution of mild soap and water. 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 disinfetants: cidex, sporicidin,
microzid, isopropyl-alcohol 70%, ethanol 70% buraton liquid.
25.2.2.3 Cleaning the SpO2 Sensor
These reusable sensors should be cleaned and disinfected, but never sterilized. The validated
cleaning agents are listed below:
Mild Detergent
Salt Solution (1%)
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.
CAUTION
Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface.
After allowing the appropriate time for the agent to work (as indicated by the
manufacturer), wipe off residues with a cloth dampened with water.
Clean with a lint-free cloth, moistened with warm water (40/104) and substances listed
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Patient Monitor User Manual Care and Cleaning
CAUTION
Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface.
After allowing the appropriate time for the agent to work (as indicated by the
manufacturer), wipe off residues with a cloth dampened with water.
Clean with a lint-free cloth, moistened with warm water (40/104) and substances listed
below. Never use strong solvents such as acetone or trichloroethylene.
Approved Cleaning Substances are Hospital-Grade Ethanol.
25.2.2.6 Other Accessories
For cleaning other accessories, please contact the manufactures for details.
25.3 Disinfection
WARNING
Do not mix disinfecting solutions (such as bleach and ammonia), or it may produce
hazardous gases.
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:
Alcohol
Aldehyde
CAUTION
Do not use EtO gas or formaldehyde to disinfect the monitor.
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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:
If the environment condition and power supply meet requirement.
If the power supply cord has damage and insulativity meets requirement.
If the device and accessories have damage.
Specified accessories.
If the alarm system can work properly.
If the recorder can work properly and the paper meets the requirement.
Battery performance
If all monitoring functions are in good conditions.
If the grounding resistance and leakage current meet requirement.
If any damage or abnormality is found, please dont use the monitor and contact local Customer
Service Center.
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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.
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Patient Monitor User Manual Warranty and Service
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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.
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Patient Monitor User Manual Accessories
EDAN
LEMO SH1 adult reusable SpO2 sensor (Only compatible with EDAN
02.01.210119
SpO2 module), (finger type, patient weight more than 40kg)
EDAN SH1 adult reusable SpO2 finger sensor (DB9), (finger type,
02.01.210120
patient weight more than 40kg)
01.13.210001 EDAN SpO2 extension cable, DB9 to LEMO, TPU, 2M
EDAN SH4 adult soft-tip SpO2 sensor, TPU, (finger type, patient
02.01.210122
weight more than 50kg)
EDAN SH4 adult silicone soft-tip SpO2 sensor, (finger type, patient
02.01.210123
weight more than 50kg)
EDAN SH5 child silicone soft-tip SpO2 sensor, (finger type, patient
02.01.210121
weight from 10kg to 50kg)
01.57.040196 Adult disposable SpO2 sensor (patient weight more than 30kg)
01.57.040197 Pediatric Disposable SpO2 sensor (patient weight from 10 to 50kg)
01.57.040198 Infant Disposable SpO2 sensor (patient weight from 3 to 20kg)
01.57.040199 Neonatal Disposable SpO2 Sensor (patient weight less than 3kg)
NELLCOR
11.15.30043 Nellcor Reusable Adult SpO2 Sensor (DS-100A OxiMax)
11.15.40096 Nellcor Reusable Adult/Neonate SpO2 Sensor (OXI-A/N OxiMax)
Nellcor SpO2 Extension Cable (Compatible with Nellcor OXI-Max
11.13.30131-11
SpO2 Module and Nellcor Sensor)
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Patient Monitor User Manual Accessories
EDAN
01.59.036118 NIBP Tube, 3m, Grey
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Patient Monitor User Manual Accessories
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Patient Monitor User Manual Accessories
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Patient Monitor User Manual Accessories
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Patient Monitor User Manual Product Specification
A Product Specification
A.1 Classification
Anti-electroshock type Class I equipment and internal powered equipment
EMC type Group 1, Class A
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+A2, EN 60601-1:1990+A1+A2,
IEC/EN 60601-1-2:2001+A1, 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,
IEC/EN 60601-2-25, AAMI/ANSI EC13, EN12470-4
EN1060-1 EN1060-3, EN1060-4
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Patient Monitor User Manual Product Specification
Altitude
Working 860hPa ~ 1060hPa
Transport and Storage 700hPa ~ 1060hPa
Power Supply 100V-240V~, 50Hz/60Hz
Current=1.0A-0.5A(iM50), Pmax=1.4A-0.7A(iM80)
FUSE T 1.6AL, 250V
A.4 Display
Product Display Messages
iM50 Display screen: 8.4 inch colour TFT A maximum of 11 waveforms
Resolution: 800600 One power LED
Two alarm LED
One charge LED
iM80 Display screen: 15 inch color TFT A maximum of 13 waveforms
Resolution: 1024 768 One power LED
Two alarm LED
One charge LED
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Patient Monitor User Manual Product Specification
A.6 Recorder
Record Width 48 mm
Paper Speed 25 mm/s, 50 mm/s
Trace Up to 3
Recording types 8 second real-time recording
Auto 8 second recording
Parameter alarm recording
Trend recording
Titration table recording
A.7 Review
Trend Review
Short 1 hrs, 1 Second Resolution
Long 120 hrs, 1 min. Resolution
Review 1200 sets NIBP measurement data
50 sets 12-lead ECG diagnosis results
A.8 ECG
A.8.1 3, 5-lead Monitoring
3-Lead: I, II, III
Lead Mode
5-Lead: I, II, III, aVR, aVL, aVF, V
Waveform 3-Lead: 1-channel waveform
5-Lead: 2-channel waveform, max. seven waveforms;
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Patient Monitor User Manual Product Specification
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
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
ASYSTOLE R on T ASYSTOLE
TRIGEMINY IRR
VENT VBRADY
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
Accuracy of Input Signal The total error and frequency response comply with ANSI/AAMI
Reconstruction EC13:2002, Sect. 4.2.9.8.
Electrode Offset Potential
500mV
Tolerance
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Patient Monitor User Manual Product Specification
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:
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
A.9 RESP
Method Trans-thoracic impedance: R-F(RA-LL), R-L (RA-LA)
Respiration excitation < 300 A, sinusoid, 62.8 kHz ( 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)
Differential input impendence > 2.5M
Waveform bandwidth 0.2 to 2.5 Hz (-3 dB)
RR measuring range:
Adult 0 to 120 rpm
Neo/Ped 0 to 150 rpm
Resolution 1 rpm
Accuracy 2 rpm
Apnea Alarm Time Setup 10s, 15s, 20s, 25s, 30s, 35s, 40s
A.10 NIBP
A.10.1 NIBP from EDAN Module
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
Measuring 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
DIA: 10 mmHg ~ 150 mmHg
MAP: 20 mmHg ~ 165 mmHg
Neonatal mode SYS: 40 mmHg ~ 135 mmHg
DIA: 10 mmHg ~ 100 mmHg
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
A.11 SpO2
A.11.1 SpO2 from EDAN Module
Measuring Range 0 ~ 100 %
Resolution 1%
Accuracy
Adult (including Pediatric) 2 % (70%~100% SpO2)
Undefined (0~69% SpO2)
Neonate 3 % (70%~100% SpO2)
Undefined (0~69% SpO2)
Pulse Rate
Measuring Range 25bpm ~ 300bpm
Resolution 1bpm
Accuracy 2bpm
Data update period 1s
Wave length
Red light 6603 nm
Infrared light 9055 nm
Emitted light energy 15 mW
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Patient Monitor User Manual Product Specification
A.12 TEMP
Channel 2
Sensor type YSI-10K and YSI-2.252K
Measuring Range 0 C ~ 50 C(32 F ~ 122 F)
Resolution 0.1C (0.1 F)
Accuracy (Without sensor) 0.1C or 0.2 F
Refresh Time Every 1s ~ 2s
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Patient Monitor User Manual Product Specification
A.14 IBP
Pressure measuring range -50 to +300 mmHg
Resolution 1 mmHg
Accuracy (without sensor) 2 % or 1 mmHg, whichever is greater
Pressure sensor
Sensitivity 5 (V/V/mmHg)
Impedance 300 to 3000
Frequency response d.c. to 12.5 or 40 Hz
Zero Range: 200 mmHg
Accuracy: 1 mmHg
Measuring range
Art 0 mmHg to 300 mmHg
PA -6 to +120mmHg
CVP/RAP/LAP/ICP -10 to +40 mmHg
P1/P2 -50 to +300 mmHg
Volume displacement of MSI 4.5 x 10-4 in3 / 100 mmHg
A.15 CO2
Method Infra-red Absorption Technique
Unit mmHg, %, Kpa
Measuring Range
EtCO2 0 mmHg ~ 150 mmHg
FiCO2 3 mmHg ~50 mmHg
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
A.16 C.O.
Method Thermodilution Technique
Measuring range
C.O. 0.1 L/min ~ 20L/min
TB 23C ~ 43C(73.4 F ~109.4 F)
TI -1C ~ 27C(30.2 F ~80.6 F)
Resolution
C.O. 0.1L/min
TB, TI +0.1C (+0.1 F)
Accuracy
C.O. For C.O. 4.0 L/min: 5%
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Patient Monitor User Manual Product Specification
A.17 AG
A.17.1 Phasein Sidestream
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),
Sevoflurane(SEV) , Desflurane(DES), awRR, MAC
Parameters
Measurement CO2, N2O, Anaesthesia Agent: infra-red absorption characteristic;
Principle O2: Paramagnetic method
Sampling Flow 50 ml/min
Rate
Work Mode Measurement, Standby
Warm-up Time < 20s
Typical Rise Time CO2 200ms
O2 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
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Patient Monitor User Manual Product Specification
HAL4) 4 vol% _ 1) _ 1) _ 1) _ 1)
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Patient Monitor User Manual Product Specification
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: Negligible interference, effect included in the specification Accuracy, all conditions
above.
Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect included in the
specification Accuracy, all conditions above.
Note 3: 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 4: According to the EN ISO 21647 standard.
Note 5: In addition to the EN ISO 21647 standard.
A.17.2 Phasein Mainstream
Module Type IRMA AX+ Displaying the concentration of CO2, N2O
and two anaesthesia agent and indentifying
two anaesthesia agent
Measurement CO2, N2O, O2, HAL, Isoflurane(ISO), Enflurane(ENF),
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Patient Monitor User Manual Product Specification
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Patient Monitor User Manual Product Specification
HAL4) 4 vol% _ 1) _ 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)
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Patient Monitor User Manual Product Specification
Note 1: Negligible interference, effect included in the specification Accuracy, all conditions
above.
Note 2: 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 3: 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 4: According to the EN ISO 21647 standard.
Note 5: In addition to the EN ISO 21647 standard.
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Patient Monitor User Manual EMC Information
B EMC Information
- Guidance and Manufactures Declaration
B.1 Electromagnetic Emissions - for all EQUIPMENT and
SYSTEMS
Guidance and manufactures 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
function. Therefore, its RF emissions are very
CISPR 11 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
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Patient Monitor User Manual EMC Information
<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.
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Patient Monitor User Manual EMC Information
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 3 .5
d = P
IEC/EN 150 kHz to 80 MHz V1
61000-4-6
3 .5
d = P 80 MHz to 800 MHz
E1
Radiated RF 3 V/m 3 V/m
7
IEC/EN
80 MHz to 2.5 GHz d = P 800 MHz to 2.5 GHz
61000-4-3 E1
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
metres (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:
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)
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Patient Monitor User Manual EMC Information
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.
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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.
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Patient Monitor User Manual Default Settings
C.4 RESP
RESP Settings ADU PED NEO
Alarm Switch On
- 172 -
Patient Monitor User Manual Default Settings
C.5 SpO2
SpO2 Settings ADU PED NEO
Alarm Switch On
Alarm Record Off
Alarm Level Medium
Alarm High Limit 100 100 95
Alarm Low Limit 90 90 88
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
Alarm High Limit 120 160 200
Alarm Low Limit 50 75 100
Pulse Volume 3
Alarm Source Auto
C.7 NIBP
NIBP Settings ADU PED NEO
Alarm Switch On
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Patient Monitor User Manual Default Settings
M3600 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
Unit C
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Patient Monitor User Manual Default Settings
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)
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%
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Patient Monitor User Manual Default Settings
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
Injectate Temperature Auto
Source
Temperature Unit C
Interval 30
Constant 0.542
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
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Patient Monitor User Manual Default Settings
- 177 -
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
CVP Central venous pressure
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
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Patient Monitor User Manual Abbreviation
- 179 -
Patient Monitor User Manual Abbreviation
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