C80 User Manual
C80 User Manual
Copyright
Version: B00
Product Name: Multi-parameter Patient Monitor
No.: 046-000964-03
Statement
All rights reserved by our company.
This instruction manual contains confidential information. It is only intended for users as a reference for
operation, maintenance and repair of our company products. No one shall disclose the contents hereof to any
other person.
No part of this manual may be reproduced, transmitted, transcribed or stored in a retrieval system in any form
or by any means, electronic or mechanical, including photocopying and recording, or translated into any other
language, without written permission of our company.
Our company shall assume no liability for any errors contained herein or any incidental or indirect damages
arising from provision, actual performance or use of this manual. This User Manual does not imply the
transfer of any proprietary right under patent law to any third party. our company shall not be liable for any
legal consequences arising out of breach of the patent law or infringement of any third-party rights.
The contents in this manual are subject to change without prior notice.
Warranty
Our company will be responsible for the safety, reliability and performance of the product within the limited
warranty period: if all of the following conditions are satisfied:
The product is used in accordance with this Manual.
The product is installed, maintained or upgraded by persons accepted or authorized by our company.
The storage, operating and electrical environments for the product comply with the product
specifications.
The serial number label or manufacturing mark of the product is clearly legible.
Return
If the products need to be returned to our company, please contact the After-sales Service Department of our
company to get the right to return the goods. You must provide the serial number of the product, which can be
found on the product’s nameplate. If the serial number is illegible, your return request will be rejected. Please
also present the production date and briefly describe the reason for return.
I
Instruction Manual for Multi-parameter Patient Monitor
Preface
This manual provides details on the performance, operations and safety instructions of Multi-parameter
Patient Monitor (hereinafter referred to as the ―monitor‖). It is the best starting point for new users of the
monitor.
Intended Readers
This user manual is only intended to trained professionals who are expected to have working knowledge of
medical procedures, practices and terminology as required for monitoring patients.
Illustrations
All illustrations provided herein are for reference only. The menus, options, values and functions shown in the
illustrations may be not exactly identical to what you see on the monitor.
Conventions:
—>: Indicates operating steps.
II
Instruction Manual for Multi-parameter Patient Monitor
Content
Chapter 1 Safety ............................................................................................................................................. 1-1
1.1 Safety Information .................................................................................................................................. 1-1
1.2 Contraindications.................................................................................................................................... 1-3
1.3 Symbols .................................................................................................................................................. 1-3
Chapter 2 Overview ....................................................................................................................................... 2-1
2.1 Product Introduction ............................................................................................................................... 2-1
2.1.1 Composition .................................................................................................................................... 2-1
2.1.2 Intended Use .................................................................................................................................... 2-1
2.2 Product Appearance................................................................................................................................ 2-2
2.2.1 Front View ....................................................................................................................................... 2-2
2.2.2 Left View ......................................................................................................................................... 2-3
2.2.3 Right View ...................................................................................................................................... 2-4
2.2.4 Rear View ........................................................................................................................................ 2-5
2.2.5 Bottom View ................................................................................................................................... 2-6
2.3 OSD (On-screen Display)....................................................................................................................... 2-6
Chapter 3 Installation .................................................................................................................................... 3-1
3.1 Unpacking and Inspection ...................................................................................................................... 3-1
3.2 Connection of AC Power Cord............................................................................................................... 3-1
3.3 Startup .................................................................................................................................................... 3-1
3.4 Connection of Sensors ............................................................................................................................ 3-2
Chapter 4 Patient Safety ................................................................................................................................ 4-1
4.1 Safety Instructions .................................................................................................................................. 4-1
4.2 Environmental Requirements ................................................................................................................. 4-1
4.3 Protective Earthing ................................................................................................................................. 4-1
4.4 Equipotential Earthing ............................................................................................................................ 4-2
4.5 Condensation .......................................................................................................................................... 4-2
Chapter 5 Basic Operations ........................................................................................................................... 5-1
5.1 Enter Main Menu.................................................................................................................................... 5-1
5.2 Enter User Maintain Menu ..................................................................................................................... 5-1
5.3 View Monitor Info.................................................................................................................................. 5-2
5.4 Enter Parameter Setup Window ............................................................................................................. 5-2
5.5 General Setup ......................................................................................................................................... 5-2
5.5.1 Time Setup ...................................................................................................................................... 5-2
5.5.2 Language Setup ............................................................................................................................... 5-2
5.5.3 Measurement Unit Setup ................................................................................................................. 5-2
5.5.4 Shortcut Key Configuration............................................................................................................. 5-3
5.5.5 Brightness Setup .............................................................................................................................. 5-3
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Instruction Manual for Multi-parameter Patient Monitor
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Instruction Manual for Multi-parameter Patient Monitor
11.3.3.4 Recommended ECG Lead Connection for Surgical Patient ..................................... 11-7
11.4 ECG Display....................................................................................................................................... 11-7
11.5 ECG Setup .......................................................................................................................................... 11-8
11.5.1 Set Lead Type .............................................................................................................................. 11-8
11.5.2 Smart Lead Off ............................................................................................................................ 11-8
11.5.3 Set Off Level ............................................................................................................................... 11-8
11.5.4 Set Lead Name for Key Monitoring ............................................................................................ 11-8
11.5.5 Set Gain ....................................................................................................................................... 11-9
11.5.6 Set Filter Mode ............................................................................................................................ 11-9
11.5.7 Set Calculate Lead ..................................................................................................................... 11-10
11.5.8 Set Notch Filter.......................................................................................................................... 11-11
11.5.9 Set Pacer Reject ......................................................................................................................... 11-11
11.5.10 HR Source ............................................................................................................................... 11-11
11.5.11 Mul. Lead Analysis ................................................................................................................. 11-12
11.5.12 Cascade .................................................................................................................................... 11-12
11.6 ST Segment Analysis ....................................................................................................................... 11-12
11.6.1 About ST Segment Analysis...................................................................................................... 11-12
11.6.2 Influence on ST Segment .......................................................................................................... 11-13
11.6.3 ST Analysis On/Off ................................................................................................................... 11-13
11.6.4 Adjust ST Point ......................................................................................................................... 11-13
11.6.5 ST Analysis Review .................................................................................................................. 11-14
11.6.6 ST Alarm ................................................................................................................................... 11-15
11.7 Arrhythmia Analysis ........................................................................................................................ 11-15
11.7.1 Arrhythmia Analysis On/Off ..................................................................................................... 11-16
11.7.2 Arrhythmia Alarm Setup ........................................................................................................... 11-16
11.7.3 Arrhythmia Threshold Setup ..................................................................................................... 11-16
11.7.4 Arrhythmia Review ................................................................................................................... 11-17
11.7.5 ARR Relearn ............................................................................................................................. 11-17
11.8 RR Intervals ...................................................................................................................................... 11-17
11.9 ECG Relearn..................................................................................................................................... 11-17
11.10 Defibrillation Synchronization ....................................................................................................... 11-18
Chapter 12 Resp Monitoring ....................................................................................................................... 12-1
12.1 Resp Measurement ............................................................................................................................. 12-1
12.2 Placement of Electrodes ..................................................................................................................... 12-1
12.2.1 Optimization of Lead Position ..................................................................................................... 12-1
12.3 Resp Display....................................................................................................................................... 12-2
12.4 Resp Calculation Mode ...................................................................................................................... 12-2
12.5 Resp Setup .......................................................................................................................................... 12-3
12.5.1 Gain ............................................................................................................................................. 12-3
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Instruction Manual for Multi-parameter Patient Monitor
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Instruction Manual for Multi-parameter Patient Monitor
17.6.2 Clean the Reusable Airway Adapter of Mainstream Sensor ....................................................... 17-9
17.6.3 Disinfection of Reusable Airway Adapter ................................................................................... 17-9
17.6.4 Disinfection Frequency of Reusable Airway Adapter ............................................................... 17-10
17.6.5 Zeroing ...................................................................................................................................... 17-10
17.7 Masimo Mainstream and Sidestream Module Related Information ................................................. 17-10
17.7.1 Zeroing ...................................................................................................................................... 17-10
17.7.1.1 Zeroing ISA CO2 Module ...................................................................................... 17-10
17.7.1.2 Zeroing IRMA CO2 Module .................................................................................. 17-11
17.7.1.3 Maintenance............................................................................................................ 17-11
17.7.1.4 CO2 Sensor LED ..................................................................................................... 17-11
17.7.2 Adverse Effects on Performance ............................................................................................... 17-12
17.7.3 Safety Alarm Information .......................................................................................................... 17-13
17.7.3.1 ISA Sidestream Gas Analyzer Safety Warning Information ................................... 17-13
17.7.3.2 IRMA Mainstream Gas Analyzer Safety Warning Information .............................. 17-14
17.7.4 Airway Obstruction ................................................................................................................... 17-15
17.7.5 Discharging Waste Gases .......................................................................................................... 17-15
17.7.6 Leakage Check .......................................................................................................................... 17-15
17.7.7 Safety Symbols .......................................................................................................................... 17-16
17.7.8 Patents and Trademarks ............................................................................................................. 17-17
17.7.9 Consumables.............................................................................................................................. 17-17
17.7.9.1 ISA Nomoline Family ............................................................................................. 17-17
17.7.9.2 IRMA Airway Adapter............................................................................................ 17-18
17.7.10 Maintenance ............................................................................................................................ 17-19
17.7.11 Cleaning the Analyzer ............................................................................................................. 17-19
Chapter 18 AG Monitoring ......................................................................................................................... 18-1
18.1 Overview ............................................................................................................................................ 18-1
18.2 AG Measurement Principle ................................................................................................................ 18-1
18.3 AG Display ......................................................................................................................................... 18-2
18.4 MAC Calculation ............................................................................................................................... 18-3
18.5 O2 Sensor ............................................................................................................................................ 18-3
18.6 Measurement Steps and Checks before Use ....................................................................................... 18-4
18.6.1 Measurement Steps ...................................................................................................................... 18-4
18.6.2 Checks before Use ....................................................................................................................... 18-5
18.7 AG Setup ............................................................................................................................................ 18-6
18.7.1 Work Mode.................................................................................................................................. 18-6
18.7.2 Gas Compensation ....................................................................................................................... 18-6
18.7.1 Pressure Unit ............................................................................................................................... 18-7
18.7.2 No Breath Alarm Delay ............................................................................................................... 18-7
18.7.3 Waveform Scale .......................................................................................................................... 18-7
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Instruction Manual for Multi-parameter Patient Monitor
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XIV
Chapter 1 Safety
Warning
Alerts you to situations that may result in serious consequences or endanger personal safety.
Failure to observe the warning information may cause severe injury or even death of user or
patient.
Caution
Alerts you to potential dangers or unsafe operations, which, if not avoided, may result in minor
injury, product failure or damage, or property damage, or cause more serious injury in the
future.
Note
Emphasizes important precautions and provides instructions or explanations for better use of
the product.
Warning
This monitor is intended for monitoring of clinical patients, and can be used only by trained,
qualified doctors and nurses.
Prior to use, the user must check the monitor and its accessories to ensure their normal and
safe operation.
Do not place the power plug used to disconnect the monitor from grid power supply in a
position not easily accessible by the operator.
Alarm volume and upper/lower alarm limits should be set depending on the patient. When a
patient is monitored, do not exclusively rely on the audible alarm system. If the alarm volume
is set too low or is completely turned off, the alarm will not be heard and the patient may be
put into danger. The most reliable monitoring method is to pay close attention to the patient’s
actual clinical conditions.
This monitor can only be connected to a power socket with protective earth. If the power socket
is not connected to an earth conductor, please use the rechargeable battery to supply power to
the monitor instead of using this socket.
Do not open the housing of the monitor to avoid the potential risk of electric shock. The
1-1
Safety
monitor must be maintained and upgraded by service personnel trained and authorized by our
company.
Please observe the local laws and regulations or the waste disposal rules of the hospital when
disposing of packaging materials. Keep the packaging materials out of the reach of children.
In order to avoid fire or explosion, never use this monitor in an environment with inflammables
such as anesthetics.
Please carefully place the power cord and the cables of various accessories to avoid
entanglement and potential strangulation and to keep the patient free from electrical
interference.
For patients with implanted pacemakers, the cardiotachometer may count in the pacemaker
pulse in the event of cardiac arrest or arrhythmia. Do not completely rely on the alarm
function of the cardiotachometer. Patients with implanted pacemakers must be closely
monitored. For the pacemaker inhibiting function of the monitor, please refer to relevant
section in this Manual.
During defibrillation, the operator should not come into contact with the patient, the monitor
or the supporting table; otherwise serious injury or death could result. Before reusing the
cables, check to confirm their functions are normal.
The equipment connected with this monitor shall form an equipotential body (effective
connection of protective earth).
In order not to cause burns (resulted from electric leakage) to the patient, please do not allow
its sensors and sensor cables to contact such equipment when connecting the Monitor to any
high-frequency electrosurgical equipment.
The physiological waveforms and parameters, alarm messages and other information displayed
by the monitor are only for reference by the doctor, which shall not be directly used as a basis
for clinical treatment.
Electromagnetic field can affect the performance of the monitor. Therefore, other devices used
near the monitor should conform to the applicable EMC requirements. For example, mobile
phones, X-ray machines and MRI devices are all potential sources of interference since they all
transmit high-intensity electromagnetic radiation.
This monitor is not a therapeutic device.
After defibrillation, the electrocardiogram (ECG) waveform must recover within 5s, other
parameters must recover within 10s.
Caution
To avoid damage to the monitor and ensure the patient’s safety, use accessories specified in this
manual.
Handle the monitor carefully to avoid damage caused by drop, collision, strong oscillation or
other external mechanical forces.
Before powering on the monitor, confirm that the supply voltage and frequency conform to the
1-2
Safety
Note
Place the monitor at a position where observation, operation and maintenance is convenient.
This user manual is based on the maximum configuration; therefore, some contents may not be
applicable to your monitor.
Keep this manual handy for easy and timely reference.
This monitor is not intended for home use.
This monitor can be used for only one patient at a time.
The service life of this monitor is 5 years.
1.2 Contraindications
Unclear
1.3 Symbols
1-3
Safety
Standby
Note: Keys on the monitor and their functions are described in ―2.2.1 Front View ‖.
Symbols on Package
1-4
Chapter 2 Overview
2.1.1 Composition
The multi-parameter monitor is composed of a main unit, anesthetic gas module, CO2 module, IBP module,
ICG module, DOP (depth of anesthesia) monitoring module, C.O. module and accessories.
The multi-parameter monitor is intended for monitoring critically ill patients in operation rooms, ICUs and
CCUs and in bedside environments. It can be used to monitor ECG (including ST segment measurement and
arrhythmia analysis), NIBP, Resp (respiration), Temp SpO2, PR (pulse rate), IBP, anesthetic gas, NICO(non-
invasive cardiac output), invasive cardiac output, DOA(depth of anesthesia), EtCO2 (end-tidal carbon
dioxide), OXYCRG (oxygen cardio-respirogram), renal function calculation, hemodynamic calculation,
oxygenation calculation, ventilation calculation, ST segment analysis, arrhythmia analysis drug calculation
and recorder of adults, children and neonates.
2-1
Overview
2 9
3 4 5 6 7 8
1 Alarm indicator
Power on/off
2 Use this key to power on/off the monitor.
key
Waveform
5 Press this key to freeze or unfreeze a waveform.
Freeze key
2-2
Overview
NIBP
7 measurement Press this key to start or stop NIBP measurement.
key
Main menu
8 Press this key to open/close the main menu.
key
Rotary knob: turn the rotary knob clockwise and counter-clockwise to move the focus; press
9
down the rotary knob to perform an action.
IBP1 jack
CO2/AG jack
2-3
Overview
Recorder
2-4
Overview
2 8
6
3
4 5
1) Handle
2) VGA port: Connect to the display with standard VGA interface which shows the current monitoring
information.
3) USB port: supporting mouse, keyboard, printer and other USB devices (plug and play).
4) Network port: connected to the central monitoring system via network cable.
signal;
3. As nurse call port: connected to the hospital’s calling system to give nurse
6) Power socket
7) Equipotential jack: When the monitor is used together with another device, use a wire to connect the
2-5
Overview
equipotential terminals of the monitor and that device. This eliminates the ground potential difference,
8) Nameplate
Warning
Only the analog or digital equipment in compliance with the specified IEC standards (like IEC
60950 for data processing equipment’s, IEC 60601-1 for medical equipment, etc.) are allowed to
be connected to the monitor. And all configurations should comply with the valid version of the
system standard IEC 60601-1. The person who connects external equipment to the signal I/O
ports should configure the medical system and ensure the medical system complies with IEC
60601-1-1 standards. If you have any question, please contact the supplier.
Do not touch the signal I/O ports if in contact with the patient, otherwise patient injury may
result.
If more than one external equipment is connected to the monitor at one time through the patient
cable socket, network connector or other signal interfaces, the total leakage current should be
compliant with the specified in IEC 60601-1.
Battery
2-6
Overview
a b c d e
4 2
Display the current physiological alarm (for example: ***RR TOO HIGH). When there are multiple
physiological alarms, each alarm message will be displayed in turn. Click on the message to enter the
Display the current technical alarm (for example: ECG LEAD OFF). When there are multiple technical
alarms, each alarm messages will be displayed in turn. Click on the message to enter the [View Technical
Alarm] window.
d) Patient info: Display the patient name, type, and pacemaker status. Click the patient info to enter the
For patients with implanted pacemakers, when [Pace] (Pacemaker) in the [Patient Info] menu is enabled,
mark is shown above ECG waveform, and icon is shown at the upper right corner of this area;
e) Clock: Show the current system time of the monitor. You can enter the [Time Setup] menu to reset the
2-7
Overview
The parameter is displayed in the same color with the corresponding waveform.
1 1 2
2 Monitor setup area: Central Monitoring System (CMS) status, WIFI connection status, SD card
status, battery status, USB drive status
CMS: indicates successful connection with CMS; indicates no connection with CMS.
USB drive: indicates a USB drive is plugged in; this icon disappears when the USB drive is
plugged out.
Battery status : shows the remaining battery power and charging/discharging status.
2-8
Chapter 3 Installation
Note
To ensure normal operation of the monitor, read this chapter and “Safety Information” and
“Patient Safety” carefully prior to installation of the monitor.
Carefully take the monitor and its accessories out of the packing box and check each of the following points.
For any problem or inconsistency, contact our company or your distributor at once.
1. Check whether all accessories are provided according to the Packing List.
Make sure the AC power supply conforms to the following specification: 100~240V, 50/60Hz1Hz.
Connect one end of the power cord supplied with the monitor to the power socket on the monitor, and insert
the other end to a grounded power outlet.
Note
Use a medical grade power strip.
When a battery is provided, the battery must be charged after transportation or storage. If the
battery is low, startup of the monitor may fail without connecting an AC power supply.
Once connected to an AC power supply, the battery will be charged until it is fully charged.
Connect the equipotential conductor when necessary. See the content about equipotential earthing in the
―Patient Safety‖.
3.3 Startup
After the power switch is turned on, the monitor enters self-test process. The red light turns on for 1 second,
then the yellow light turns on for 1 second. After the our company logo is displayed, the monitor shows the
main interface, with a ―beep‖ sound indicating the startup has been completed.
3-1
Installation
Prior to patient monitoring, confirm that the monitor is free from mechanical damage and that cables and
accessories are correctly connected.
Note
The system gives an alarm when a critical error is detected in the self-test.
Check all monitoring functions to ensure that the monitor can function normally.
The battery must be charged after each use to ensure sufficient battery power is available.
After shut-down, in order to extend its service life, wait for at least 1 minute before you restart
the monitor.
Warning
If any evidence of failure or any error message is found, Do not use this monitor. Contact a
service engineer of our company or a technician in your hospital.
Connect the sensors to the monitor and the patient according to the detailed description in the relevant
chapters.
3-2
Chapter 4 Patient Safety
This monitor is designed in accordance with international safety standards for medical electrical equipment. It
is provided with defibrillation-proof and electrosurgical protection with floating ground. Use correct
electrodes (see the chapter ―ECG Monitoring‖) and apply them according to the manufacturer’s guidance.
Please observe the following instructions to ensure absolute safety of electrical installation.
The monitor should be used in an environment that can reasonably avoid vibration, dust, corrosive or
explosive gases, extreme temperature and humidity, etc.
When the monitor is installed in an enclosed space, make sure the space is well ventilated. Leave at least 2
inches (5cm) free space around the monitor for air circulation. Also, leave sufficient space around it for easy
operation and maintenance.
The monitor should be stored and operated within the ambient temperature of -20°C ~+60°C and 5°C ~40°C
respectively. Hostile ambient temperature may affect the precision and accuracy of the monitor, and cause
damage to the components and circuits.
To protect both the patient and the operator, the housing of the monitor must be earthed. The monitor is
supplied with a detachable 3-prong power cord, which shall be inserted into a grounded power outlet to
connect the monitor to the earth. If grounded power outlet is not available, contact the electrician in your
hospital.
Warning
It is forbidden to connect the 3-prong power cord to a 2-prong power outlet.
Connect the earth wire to the equipotential connector of the monitor. If you have doubt about whether devices
used together involves any electrical risks, such as risk caused by accumulation of leakage current, consult an
expert in this field to ensure the safety of all devices.
4-1
Patient Safety
The monitor must be connected to a power supply with protective earthing. For cardiac or cerebral
examination, the monitor must be separately connected to an equipotential earthing system. Connect one end
of the equipotential conductor (potential equalization conductor) to the equipotential connector on the rear
panel of the monitor, and connect the other end to a connector of the equipotential earthing system. In the
event that the protective earthing system is damaged, the equipotential earthing system can provide protection
to the monitor.
Cardiac (or cerebral) examination can only be performed in a room installed with a protective earthing system.
Before each use, check whether the monitor is in normal working status. Cables connecting the patient to the
monitor cannot be tainted with electrolyte.
Warning
If the protective earthing system is not stable, use the built-in battery to supply power to the
monitor.
Note
If the use of the instrument is affected by equipotential earthing, contact the Company’s After-
sales Service Department or agents.
4.5 Condensation
Ensure that the monitor is free from condensation during operation. When the monitor is moved from one
room to another, condensation may be formed due to exposure to damp air and temperature difference. In this
case, do not use the monitor until it gets dry.
4-2
Chapter 5 Basic Operations
Note
The distance between the operator and the monitor should be less than 1 m so that the operator
can observe the monitor easily.
Select Main Menu on the screen or press the key on the front panel to enter the [Main Menu] window,
where you can set up system menus easily. See the figure below:
Enter [Main Menu] → [Maintain]. Enter the correct password in the pop-up [Password] dialog to enter the
[User Maintain] menu.
5-1
Basic Operations
Enter [User Maintain] → [Monitor Info] (Monitor Information). Monitor info includes software and hardware
version, etc., which facilitate the manufacturer to maintain and trace the monitor.
You can set up parameters displayed on the screen after entering the setup windows in the following ways:
Via waveform area: Click a waveform to open the corresponding setup window. For example, you can
Via parameter area: Click a parameter to open the corresponding setup window. For example, you can
click in the ECG parameter area to open the [ECG Setup] window.
Via [Parameter Setup] menu: Press the [Parameter Setup] shortcut key (or enter [Main Menu] →
[Parameter Setup]) to open the [Parameter Setup] menu, in which you can select and set up the desired
parameter.
Enter [User Maintain] → [Time Setup]. Set up the system clock according to the local time zone, including
Year, Month, Day, Hour, Minute (Min), Second (s), Date Format, and Time Format. The settings become
effective immediately.
Enter [User Maintain] → [Language]. Select the user interface language that you want.
Enter [User Maintain] → [Unit Setup]. Set up the units you want to use for parameters, including [Height
Unit], [Weight Unit], [Press Unit] (Pressure Unit), [CVP Unit], [Temp Unit] and [CO2 Unit].
5-2
Basic Operations
You can modify shortcut keys on the lower menu bar as needed.
Enter [User Maintain] → [Quick Key Config] to open the menu, as shown in the figure below:
Right Area
Left Area
Middle Area
Three shortcut key areas respectively represent the left, middle and right section of the lower menu bar on the
screen.
Click to open the [Quick key] menu, in which you can select the shortcut keys you want to add. After
2) Select the appropriate brightness level between 10 (the darkest) ~100 (the brightest).
In dark environment, you can turn on the backlight for the keyboard.
Enter [Main Menu] → [Screen Config] → [Key Light].
5-3
Basic Operations
Enter [Main Menu] → [Screen Config] → [Screen Layout]. In this window, you can adjust the position of
waveforms and parameters. Only parameters that have been turned ON are shown on the screen.
1 1
4
Fig. 5-3 Screen Layout
The first line of this window always shows the first ECG waveform.
1) Font size: You can select between [Standard] or [Big Font].
2) Waveform area: Waveforms are displayed on the left and parameters on the right. The waveform and its
3) In area 3, you can set waveform and parameter. If a particular line in the area 4 has no parameter, the
corresponding line in area 3 will display parameters and waveforms at the same time.
4) Parameters without waveform: Only data are displayed for parameters in this area.
After layout setup, click at the upper right corner of the [Screen Layout] window to exit.
which depends on the setting of the Minimum Alarm Volume) and 10 (the loudest volume). See the
5-4
Basic Operations
2) Select [QRS Vol] (QRS Volume): Select the appropriate volume within 0~10;
To freeze all waveforms on the screen, click the Freeze shortcut key on the lower menu bar of the screen, or
directly press the Freeze button on the front panel of the monitor.
In the [Freeze] window, use the Forward or Backward key (or use the rotary knob to select the Forward or
Backward key and turn the knob) to move the frozen waveform leftward or rightward. A down arrow is
shown on the right side above the top waveform, with a time scale displayed to the left of the arrow. The
freeze time is marked as [0s ]. With the leftward movement of the waveform, the time scale will change to [-
1s ], [-2s ], [-3s ]... in sequence, indicating how many seconds ago the waveform currently displayed is
plotted.
Record Frozen Waveform
In the [Freeze] window, select the waveform you want to print ([Wave1], [Wave2] or [Wave3]) and click the
Record key. The recorder will start printing the frozen waveform.
Unfreeze
Click at the upper right corner of the [Freeze] window.
Press the Freeze key on the front panel again.
5-5
Basic Operations
Set the lock screen if you do not want to use the touch function. Long-press the main menu icon to lock the
screen and display [Screen is locked! Long press main menu to unlock.] as a prompt at the lower left on the
screen.
Event setup involves saving waveforms for manually triggered events. During patient monitoring, the
occurrence of some events may have certain impacts on the patient, resulting in changes in some waveforms
or parameters. You can select waveforms for manually triggered events in [Manual Trigger] settings. When an
event is triggered, the monitor will mark it and save the corresponding waveforms. You can review the event
later to analyze its impacts.
The steps are described below:
1) Enter [Main Menu] → [Event Setup].
4) Select [Manual Trigger]. [Manual Trigger Successful] will be shown at the bottom left of the screen.
5) To review a manually triggered event, select it in the [User Event] menu under [Alarm Event Review].
5-6
Basic Operations
You can turn On/Off parameter modules as needed. When a parameter module is turned OFF, the
corresponding waveform and parameter are not displayed on the screen, and the monitor stops measurement,
analysis and alarm function for that module.
1) Enter [User Maintain] → [Module Switch Setup].
Users can set the password for entering the ―User Maintenance‖ according to their own needs.
Enter [User Maintain] → [Set User PassWord].
Upon startup, the monitor automatically enters the monitoring mode for patient monitoring.
If you don’t want to shut down the monitor when there is no patient to monitor, click the [Standby] shortcut
key to put the monitor into standby mode.
In standby mode:
There is no alarm and waveform on the screen.
This monitor provides night mode to minimize disturbing the patient. After exiting this mode, the monitor will
restore the settings before entering night mode.
To activate night mode:
2) The [Night Mode Setup] window pops up. Select [Night Mode] to enter this mode.
5-7
Basic Operations
3) Set up [Alm Vol], [QRS Vol], [Key Vol], [Brightness], and [Stop NIBP Measure].
To exit night mode:
2) The [Night Mode Setup] window pops up. Select [Night Mode].
3) The warning message [Exit Night Mode?] is displayed. Select [Yes] to exit night mode.
In order to protect patient privacy, the monitoring data is not displayed on the screen in this mode. It can be
activated only under CMS (Central Monitoring System) monitoring.
To activate privacy mode:
Enter [Main Menu] → [Screen Config] → [Privacy Mode].
When privacy mode is activated:
1) The message [In monitoring...press any key to exit privacy mode!] is shown on the monitor screen.
2) The monitoring continues normally but the patient data can be viewed only on the central monitoring
station.
3) Alarms can still be triggered, but alarm sound and alarm light are available only on the central
monitoring station.
4) All system sounds of the monitor are muted, including QRS and beat sounds as well as various prompt
tones.
The monitor exits from the privacy mode in any of the following conditions:
You press any key (except Power key).
5.6.5 Demo
Enter [User Maintain] → [DEMO] to put the monitor into demonstration mode.
Warning
Demo waveforms are used to simulate the actual monitoring process. Demo mode can only be
used to demonstrate the device performance and assist in training course. In actual clinical use,
it is forbidden to use the demo mode, because medical workers may mistake the demo data for
waveforms and parameters of the patient, which will put the patient in danger.
5-8
Chapter 6 Configuration Management
6.1 Overview
For continuous monitoring of a patient, the monitor may require adjustment of some settings according to the
actual patient conditions. The assembly of predefined settings used to operate the monitor is called a
configuration. In order to configure the monitor more effectively and rapidly, this monitor provides a variety
of configurations to meet the requirements of different patient types and different hospital departments. You
can also customize a configuration according to actual conditions and save it as a user-defined configuration.
Configuration info of the monitor mainly includes:
Parameter Configuration
Settings related to parameter measurements, such as Wave Gain, Speed, Unit, Alarm ON/OFF, and Alarm
Limit Setup.
General Configuration
The monitor’s general settings, such as Alarm Setup, Screen Layout, and Record.
Maintenance Configuration
Settings related to maintenance, such as Wave Draw, Language, and Nurse Call.
For default system configuration, see Appendix IV Default Configuration.
Warning
The Config Manage function is protected with password. It can only be operated and approved
by professional medical workers.
6-1
Configuration Management
Note
Upon startup or to admit a new patient, you need to check the current configuration of the
monitor. This can be viewed in [Load Config]. The configuration name marked with the symbol
—> in front is the currently loaded configuration.
Use of different configurations on monitors in the same department (e.g., ICU or Cardiac OR)
may result in danger.
Make sure the configuration you select is appropriate for the patient being monitored.
When the monitor is switched to another department, you need to admit the patient, change the
patient type, and load the corresponding default factory configuration.
The monitor can memorize system configuration.
[Save as User Config]: You can save the current configuration as a user config file by entering a config file
name. The config file name can consist of alphanumeric characters or underscore (_), but cannot be empty. If
the name you have entered is already used by another config file, the system will prompt whether you want to
overwrite that config file. The system can save at most 3 user config files.
[Delete Config]: Delete user configs currently saved in the monitor. In this menu, all user config files saved
under the current department are listed, with patient type in brackets added after each config file name. For
example, John (ADU) indicates that the config file ―John‖ is saved when the patient type is ADU.
[Load Config]: The monitor supports up to 6 configurations for one department. Configurations available for
loading include the default factory configurations for the current patient type, user-defined configurations, and
configurations imported from the USB flash drive. Patient type is marked after the user-defined configuration.
After you load configurations, they will replace the current configurations and become effective.
Enter [Load Config]: enter [Main Menu] or [Config Manage] → [Load Config].
[Import Config from USB]: You can import configurations from a USB flash drive if there are less than 6
configurations for the current department in the system.
[Export Config to USB]: Export user-defined configurations in the system to a USB flash drive.
[Startup Configuration]: you can set up the configuration adopted by the monitor when it restarts.
But after the monitor powers off, the configurations will be set according to the following. With 120s after
powering off, the monitor will automatically set the latest configurations; 120s later after powering off, the
monitor will set the configurations according to [Startup Configuration].
6.2 Example
The operation steps of configuration management are described below, with the user-defined configuration
[John] used as an example:
1) Enter [Main Menu] → [Config Manage]. Enter the user password to open the [Config Manage] menu.
6-2
Configuration Management
2) In [Config Manage] menu, select [Department], and choose the appropriate department.
3) In [Main Menu] or [Config Manage] menu, select [Load Config] and load a configuration. You can
choose a default factory configuration or a user-defined configuration appropriate for the patient type.
6-3
Configuration Management
4) User can get a user-defined configuration by modifying the current configuration used by the monitor. In
[Config Manage] menu, select [Save As User Config] to enter the [Config Name] interface, as shown in
figure below. Enter the file name [John], and press the Enter key to save it.
5) In [Main Menu] or [Config Manage] menu, select [Load Config]. [John] will be shown in the list of
configurations. You can select it or select from default factory configurations or other user-defined
configurations.
6-4
Configuration Management
6) If this configuration is no longer needed, you can select [Delete Config] in [Config Manage] menu, and
7) In step 5), you can also import a configuration from a USB flash drive.
Insert a USB flash drive containing config files to the USB port on the monitor. After the USB flash
drive is recognized, select [Import Config from USB] in [Config Manage] menu, When [Import
Succeeded] is shown at the bottom left of the screen, the imported configurations will appear in the list
under [Load Config].
6-5
Configuration Management
If an imported configuration is no longer needed, you can select [Delete Config] in [Config Manage]
menu, to delete it.
If the inserted USB flash drive contains no user config file, the monitor will prompt [No User Config
Exists].
8) User-defined configurations can also be exported to a USB flash drive for backup purpose.
Insert a USB flash drive, and select [Export Config to USB] in [Config Manage] menu, When [Export
Succeeded] is shown at the bottom of the screen, the export is finished.
If no user-defined configuration exists in the monitor, when you select [Export Config to USB], the
monitor will prompt [No User Config Exists].
6-6
Configuration Management
9) You can set up the configuration adopted by the monitor when it restarts. In [Config Manage] menu,
enter [Configuration on Startup] and select from [Use Last CFG], [Default Adu Config], [Default Ped
6-7
Chapter 7 Patient Management
You can enter the [Patient Manage] menu in three ways: a) Enter [Main Menu] and select [Patient Manage]; b)
Click the [Patient Manage] shortcut key on the lower menu bar; c) Click in the patient info area on the upper
menu bar.
7.1 Admit
When a patient is connected to the monitor, the monitor can display and save the patient’s physiological data
even if the patient is not admitted. But correct patient admission is important for patient monitoring.
You can admit and discharge a patient in the [Patient Manage] window.
To admit a hospitalized patient:
1) Enter [Patient Manage] → [Admit].
2) If another patient has been admitted on the monitor, the prompt message [Discharge current patient &
admit new patient?] will be shown. Select [Yes] to discharge the existing patient. If no patient has been
admitted, the prompt message [Whether to apply the monitor data to the patient to be admitted?] will be
shown.
3) Enter patient info in the [Patient Info] menu. Pay attention that [Pat Type] (Patient Type) and [Pace]
(Pacemaker) should be set up correctly. You can user EN or Handwriting input methods to enter
information.
[Pat Type]: the options include [ADU] (Adult), [PED] (Pediatric), [NEO] (Neonatal). It is essential
to select the correct patient type, as it determines the algorithm used to calculate and process the
patient data, as well as certain safety limits and alarm limits applied to the patient.
[Pace]: This setting determines whether the monitor displays pacemaker pulse. When [Pace] is set to
―ON‖ and pacemaker signal is detected, symbol will be shown above the ECG waveform, and
will be shown at the upper right corner of the message prompt area. When [Pace] is set to
―OFF‖, no prompt message or symbol will be displayed, and pacemaker pulse will be filtered out.
7-1
Patient Management
Warning
No matter whether a patient is admitted, the monitor assigns a default value to both [Pat
Type] and [Pace]. Make sure the settings in Patient Info are consistent with the patient’s
actual conditions prior to monitoring.
When the patient type is changed, the system will load the factory default
configuration.Usually, the alarm limits should be verified before patient monitoring to ensure
that these alarm limits suit your patient. When the patient type is not changed, the current
configuration is not changed.
If the patient is not implanted with a pacemaker, [Pace] should be set to “OFF”. Otherwise,
the system cannot detect arrhythmia related to ventricular premature beats (including PVCs
count), and ST segment analysis will not be carried out.
If the patient is implanted with a pacemaker, [Pace] should be set to “ON”. Otherwise,
pacemaker pulse may be counted as normal QRS wave, resulting in failure to detect the “ECG
Lost” alarm.
The Quick Admit mode can be used in emergency situation when there is not enough time to fill in patient
info. You must complete the patient info later.
1) Enter [Patient Manage] → [Quick Admit].
2) If another patient has been admitted on the monitor, the prompt message [Discharge current patient?
7-2
Patient Management
Admit new patient?] will be shown. Select [Yes] to discharge the existing patient. If no patient has been
admitted, the prompt message [Apply the monitoring data to the patient to be admitted?] will be shown.
3) Enter the [Patient Info] window, set up [Pat Type] and [Pace], and then close the window.
7.3 Discharge
[Yes]: Discharge the current patient. The patient data monitored will be archived automatically if the
monitor is mounted with a SD card. You can review the archived patient data in [Pat File Manage].
Warning
After the patient is discharged, [Pace] will be automatically set to OFF.
You can inquire, review, delete and export archived patient files in Pat File Manage (Patient File
Management). However, patient files cannot be archived if the monitor is not mounted with a SD card.
[Query]: Enter the patient name in the field at the lower left corner of the [Pat File Manage] window and click
[Query] to search for the patient’s file.
[View]: Select the patient info bar you want to review. Click [View] to open [Review] menu, in which you
can view [Patient Info], [Trend Review], [NIBP Review], [Alarm Event Review] and [Wave Review].
[Delete]: Delete the selected patient file.
[Export]: Export the selected patient file to a USB flash drive or PC.
The operation steps of patient file management are described below:
1) Enter [Main Menu] → [Pat File Manage].
2) Enter a patient name in the input field at the lower left corner of the window.
If there are multiple patient files found, click the keys to select the one you want to view; click the
7-3
Patient Management
2) When you check at the lower left corner, all patient files will be selected. At this time, you can click
If a single patient file is selected, select [Export] to open the [Data Export] menu.
6) Select [Data Export] to start export. When it is finished, the prompt message [Data export
If multiple patient files are selected, operations steps are the same with those for single patient file
Warning
As for patient alarm messages, physiological and technical alarms are saved in the patient file.
In the event of a power outage, alarm events can be saved in the patient file.
When exporting data to a USB disk, do not remove the USB disk until the export process is
7-4
Patient Management
Note
When the monitor is shut down, the data for the monitoring period before the shutdown will
be saved automatically. Upon startup of the monitor, the system will automatically create a
new period (i.e., current period data).
The monitor allows data storage upon power failure.
The monitor creates a patient file and save its data even if no patient has been admitted. Such patient file is a
blank Temp Case (Temporary Case), which can be automatically deleted in monitor settings. Also, the
monitor can automatically delete old cases when the SD card is full.
1) Enter [User Maintain] → [Save Tactics];
2) Select [Auto Del Temp Case] and [Del old case] respectively, and switch them between ―ON‖ and
―OFF‖.
7-5
Chapter 8 User Interface
This monitor provides multiple user interface styles, such as Standard, Big Font, Trend, OxyCRG, List, View
Bed, 7-Lead ECG, and 7-Lead Half Screen interfaces, 12-Lead ECG. You can select appropriate user
interface styles according to different demands, so as to obtain different patient information on the screen. The
waveform displayed on each channel is depending on the monitor configuration. You can also select the
waveforms you want to display in the [Screen Layout] menu. This chapter introduces the characteristics of
some work interfaces.
To select your desired user interface style:
1) Select the [Screens] shortcut key, or select [Screens] under [Main Menu].
8.1 Standard
The monitor shows the Standard interface by default. If all optional modules are equipped, this interface can
display waveforms of at most 8 channels together with their parameters.
In Big Font interface, parameters are shown in large font, so that you can see items on the screen within a
certain distance. This interface can display four parameters and four waveforms.
8-1
User Interface
8.3 Trend
The Trend interface displays the short-term trend graphs of a range of waveforms and parameters. In each
trend graph, on the top is the trend name, on the left is the parameter scale, and at the bottom is the time scale.
8-2
User Interface
8.4 OxyCRG
OxyCRG interface consists of HR trend graph, SpO2 trend graph and RR trend graph or Resp waveform.
8-3
User Interface
8.5 List
The list interface occupies half of the waveform area. You can review recently measured parameters in this
interface. 7 sets of data are displayed on each page.
For example, you can select the NIBP list to enter the List View interface, in which you can view the
measured data for NIBP parameters by pages.
8-4
User Interface
With the View Bed function, the monitor can display contents on the screen of another monitor connected to
the central monitoring system (CMS).
Note
This function is optional and only available between monitors provided by our company.
8-5
User Interface
① ⑤
②
④
③ ⑥
② Waveform area: You can select a waveform to open the setup window, and then set the waveforms to be
displayed in the [Wave Exchange] menu.
③ Net Bed (Network Bed): You can monitor another bed by entering its bed number in the CMS system.
④ Parameter area: You can click in this area to open the setup window, and select other parameters to be
displayed.
⑤ Technical alarm message area: When multiple technical alarm messages exist, each one will be
displayed in turn.
⑥ Function keys:
[View Bed] - Select it to monitor another bed .
When the lead type is 5-lead, you can select the 7-Lead ECG interface to show the waveforms of ―I, II, III,
AVR, AVL, AVF and V‖ leads. Other waveforms will not be displayed.
8-6
User Interface
When the lead type is 5-lead, you can select the 7-Lead Half Screen interface to display the waveforms of ―I,
II, III, AVR, AVL, AVF and V‖ leads in the upper half of the waveform area.
When the lead type is 12-lead, you can select the 12-Lead ECG interface. Other waveforms will not be
displayed. You can change the [Channel Format] under the interface of [12-Lead ECG]: [2x6+1] or [1x12].
8-7
User Interface
2) Wave style.
8-8
User Interface
You can set up the interface style for all parameters using the same method described in this section.
1) In the Standard interface, select the waveform. For example: Select the ECG wave [II] or [I] → [ECG
Wave] → [Sweep].
2) In the [Module Color] menu, you can select a waveform and set its color to: [Red], [Orange], [Yellow],
8-9
Chapter 9 Alarms
When a patient under monitoring has abnormal vital signs, or when failure occurs in the monitor, the system
will give audio and visual alarm to remind the medical workers.
The alarm system functions in real-time monitoring mode. In standby mode, alarm sound and light will be
disabled.
When there are multiple alarms and prompt messages, each message will be displayed in turn.
Warning
Use of different configuration on different monitors in one area (e.g., ICU or OR) may result in
danger to the patient.
Alarms generated by the monitor are classified into physiological and technical alarms.
Physiological alarm
A physiological alarm is generated when a certain physiological parameter of the patient is beyond the
high/low alarm limit or the patient has physiological disorder. Physiological alarm messages are displayed in
the physiological alarm area in the upper part of the screen.
Technical alarm
A technical alarm, also known as a system error message, is triggered when a system function cannot work
normally or the monitoring result is unreasonable due to improper operation or system failure. A technical
alarm message is displayed in the technical alarm area in the upper part of the screen.
Note
In addition to physiological and technical alarms, the monitor also show messages about system
status. Generally, these messages shown in the system message area are not related to vital signs
of the patient.
Physiological and technical alarms are classified into high, medium and low-level alarms by severity.
9-1
Alarms
When an alarm is generated, the monitor will use the following alarm modes to alert the user:
Light Alarm
Sound Alarm
Alarm Message
Blinking Parameter
For light alarms, sound alarms and alarm messages, the alarm levels are differentiated in the following ways.
Two alarm indicators at the upper left corner of the monitor indicate alarm levels with different light colors
and blinking frequencies.
Physiological Alarm:
High-level: Red, blinking.
Medium-level: Yellow, blinking.
Low-level: Yellow, remaining on
Technical Alarm:
High-level: Red, blinking.
Medium-level: Yellow, blinking.
Low-level: Yellow, remaining on.
9-2
Alarms
The monitor indicates alarm levels with alarm sounds with different intervals.
High-level: beep-beep-beep--beep-beep----beep-beep-beep--beep-beep
Medium-level: beep-beep-beep
Low-level: beep
Warning
Both the bedside monitor and the CMS are provided with sound alarm function.
When this monitor is connected to the CMS, you can use the same upper and lower alarm limits
for the monitor and CMS. But if you enable alarm delay on this monitor, it will not give alarm
when the CMS has given an alarm.
When multiple alarms of different levels are generated simultaneously, the monitor will activate
the warning sound and light for the highest-level alarm.
Alarm messages are shown in the physiological alarm area or technical alarm area on the screen.
Different marks are added in front of physiological alarm messages to indicate the alarm levels:
High-level: ***
Medium-level: **
Low-level: *
When a parameter reaches the alarm limit, the parameter and its upper and lower limits will blink once every
second, indicating the measured result is beyond the upper or lower limit.
You can press the key on the control panel (or the [Alm Pause] shortcut key on the screen) to quickly
enter the alarm pause state:
Alarm sound, alarm light and alarm message are disabled for physiological alarms, and no physiological
9-3
Alarms
The physiological alarm message area shows the prompt message ―Alm Pause XXXs‖.
Alarm sound and alarm light are disabled for technical alarms; if a new technical alarm is triggered, only
In the event of the ―Battery Too Low‖ alarm, this alarm will be resumed automatically to give alarm
pause time (set by user) expires, the monitor will cancel alarm pause automatically; user can press the
key (or the [Alm Pause] shortcut key on the screen) to cancel alarm pause.
Operation steps for alarm pause:
1) Enter [User Maintain] → [Alarm Setup] → [Alm Pause Time].
2) Set the appropriate pause time: [1min], [2min], [3min], [5min], [10min], [15min].
The Alarm OFF function is effective just for physiological alarms. When the function is activated, the Alarm
OFF sign will be shown on the left side below the corresponding parameter in the parameter area:
For physiological alarms, sound, light and text prompts will be disabled, and no new physiological
also select the [Alarm Setup] shortcut key to directly enter [Alarm Limit Setup].
2) Select [All Alarm Off] to disable alarms against all parameters. If the alarm ON/OFF icon of a
parameter is switched to ―OFF‖, alarms for that parameter will be disabled.
To exit the alarm OFF state of all parameters, select [All Alarm On]; to exit the alarm OFF state of one
parameter, switch the alarm ON/OFF icon of that parameter to ―ON‖.
Warning
If the alarm function is set to “OFF”, the monitor cannot trigger alarm when there is an alarm
condition. Therefore, the operator should use this function with caution.
9-4
Alarms
If the monitor is equipped with a recorder, the monitor will trigger output of the parameter waveform and
value by the recorder if all the following conditions are satisfied: when data of a parameter is abnormal; the
alarm switch is turned ON; and [Alm Record] is set to ON.
1) Enter [Main Menu] → [Alarm Setup] → [Alarm Record Setup].
3) To activate alarm recording for a parameter, switch the alarm record icon to ―ON‖; to activate
alarm recording for all parameters, select [All Rec. On].
4) User can switch the alarm record icon to ―OFF‖ to deactivate parameters requiring alarm record; to
2) Set the appropriate upper and lower limits for the parameter.
9-5
Alarms
For parameters subject to general alarms, the alarm limit setup methods are basically the same. Here RESP is
taken as an example:
1) Select the RESP parameter area; enter the Setup menu → [Alarm Limit Setup].
2) Select the check box at the lower left corner of the Setup window for the corresponding parameter to
switch the alarm level.
3) Set the appropriate upper and lower limits for the parameter under the current level.
The monitor can automatically set up the Auto Alarm Limits for the currently measured parameters according
to the patient type.
Before applying these alarm limits, make sure they are appropriate for the patient. If not, you need to
manually set the alarm limits.
Note
When resetting to default factory configurations, alarm limits of the parameters will also
change. See Appendix IV “Default Configurations” for details.
Warning
When setting alarm limits to extreme values, the alarm system may be useless.
When setting upper and lower alarm limits, make sure the patient type is correct (ADU, PED
or NEO).
If you have set up the upper and lower alarm limits manually, the monitor will display these
upper and lower alarm limits instead of the default alarm limits of the system.
After powering off accidentally, the equipment will save the latest setting with 120s after
powering off, 120s later after powering off, the monitor will set the configurations according to
[Startup Configuration].
The system provides five options for parameter alarm delay: [Not Allowed], [5s], [10s], [15s] and [20s]. If
[Not Allowed] is selected, when the measured parameter is beyond the alarm limit, the monitor gives alarm
9-6
Alarms
immediately. If [5s]/[10s]/[15s]/[20s] alarm delay is selected, the monitor gives alarm when the measured
parameter has been beyond the alarm limit for 5s, 10s, 15, 20s, respectively.
NOTE: Alarm delay cannot be applied to ECG and IBP.
Operation steps:
1) Enter [User Maintain] → [Alarm Setup] → [Alarm Delay].
Do not set the minimum alarm volume too low; otherwise, you cannot hear the alarm sound, which may put
the patient into danger. Follow the operation steps below to set up the minimum alarm volume:
1) Enter [User Maintain] → [Alarm Setup] → [Min. Alm Volume].
Note
When the alarm volume is turned down, the alarm sound may go unheard; therefore, the
minimum alarm volume should be adjusted to be higher than environmental noise.
The sound pressure level of alarm sounds generated by this monitor is 45-85db.
1) Enter [Main Menu] → [Volume Setup], or select the [Volume Setup] shortcut key.
3) Select the volume within the range of X~10. X represents the lowest volume, which depends on the
When the alarm volume is set to 0, the icon will be shown in the message prompt area of the screen,
Alarm‖, which can respectively modify the volumes of the advanced alarm and the intermediate alarm.
Warning
When the alarm volume of the system is set to 0, the monitor cannot make any alarm sound
even if a new alarm is generated. Therefore, the operator should use this function with caution.
Do not exclusively rely on the sound alarm system. Otherwise, the patient may be put in a
9-7
Alarms
dangerous situation if the alarm volume is low. User should pay close attention to the patient’s
actual clinical conditions.
Maximum alarm volume is no more than 10.
When the alarm volume is set to 0, or the alarm function is turned OFF, or the CPB mode is selected, the
monitor can provide periodic prompt tone to remind that there is activated alarm in the system. Follow the
operation steps below to set up alarm reminders.
1) Enter [User Maintain] → [Alarm Setup].
4) Select [Reminder Volume]: set it to a value between 1 (the minimum volume) ~10 (the maximum
volume).
You can reset the current alarm via the [Alarm Reset] shortcut key on the lower menu bar on the screen:
Cease the audio alarm indication of all physiological alarms and technical alarms.
End alarm paused status, thus re-enabling the alarm system to respond to future alarm conditions.
For lead off and sensor off technical alarm condition, clear the alarm lamp flashing and audio alarm
indication and the alarm messages turn to prompt messages displayed in the technical alarm message
area
When this monitor is connected to another bedside monitor via network, the alarm information on that
monitor can be observed on this monitor, including alarm messages, waveforms and parameters.
In the [View Bed] interface, you can view the alarm conditions of the monitor for another bed.
You can reset the alarm of the other bed by selecting the [Reset] button in the [View Bed] window.
9-8
Alarms
When the patient will undergo cardiopulmonary bypass in the [OR] department, you can select the [CPB
mode] (Cardiopulmonary Bypass Mode). In this mode, physiological alarms except the following are
suspended indefinitely.
FiCO2/EtCO2 Too High
Upon startup of the monitor, the alarm system will perform self-test of alarm light and sound.
Phenomena during self-test:
Upon startup of the monitor:
The red alarm light and the yellow light turn on for 1s in turn, and then the alarm lights turn off.
At the time of alarm light self-test, the alarm system makes a ―beep‖ sound for self-test of alarm sound.
Requirement on sound self-test: The low-level alarm is used, with the alarm volume set to Level 5.
After self-test, the system can be further tested through SpO2 or NIBP parameter. For example:
1) Connect the SpO2 cable to the monitor.
3) Directly select [Alm Vol] on the lower menu bar of the screen. Set [Alm Vol] to any level among 0~10.
4) When the measured value is beyond the upper/lower alarm limit, confirm whether the changes in sound,
light and parameter blinking on the monitor conform to the descriptions in the section ―Light Alarm‖,
―Sound Alarm‖, ―Alarm Message‖, and ―Alarm Parameter Blink‖ in this chapter. Meanwhile, the
physiological alarm message area shows ―SpO2 Too High‖ or ―SpO2 Too Low‖.
5) Pull out the SpO2 sensor from the monitor; the technical alarm message area shows ―SpO2 Sensor Off‖.
9-9
Chapter 10 PR Setup
10.1 Overview
Mechanical activity of the heart causes artery pulse. PR value can be obtained by measuring the pulse. Color
of the PR parameter area is consistent with the color in which the parameter of PR source is shown.
10.2 PR Source
Select the PR parameter area to enter the Setup menu, where you can set PR Source.
[SpO2]: Display the pulse rate value from SpO2;
[NIBP]: Display the pulse rate value from NIBP;
[ART], [PA], [UAP], [BAP], [FAP], [P1], [P2], [P3], [P4], [LV], [AO]: Specific pressure parameters from
IBP; display the pulse rate value from IBP. (Which pressure parameter can be selected as the source depends
on which pressure parameter is monitored by the monitor)
Select the PR parameter area to enter the Setup menu, where you can carry out alarm limit setup.
10-1
Chapter 11 ECG Monitoring
Electrocardiography (ECG) monitors continuous electrical activity of the patient’s heart, which is reflected on
the monitor in the form of wave and value, so as to accurately assess the current physiological status of the
patient. Therefore, you must make sure the ECG cables are connected properly to obtain correct measurement
values. The device can display 3-lead, 5-lead ECG or 12-lead ECG waves according to your need.
Warning
During defibrillation, the operator should not come into contact with the patient, desk or
device.
Prior to monitoring, please test the sensor cable to see if it is normal. When the ECG cable is
disconnected from the jack, the screen will display the prompt message “ECG Lead Off” and
generate the alarm sound.
When this monitor is used for ECG signal monitoring, ECG leads provided by our company
must be used.
When connecting the electrodes or patient cable, please ensure that the patient does not come
into contact with any other conductive parts or the ground. Especially, please confirm that all
ECG electrodes (including neutral electrode) are attached onto the patient’s body and will not
come into contact with any conductive parts or the ground.
Check whether the ECG electrode patch can irritate skin every day. If there is any sign of
allergy, replace the electrode or change its position.
Prior to ECG monitoring, please check the ECG cable. When the ECG cable is disconnected,
the monitor will trigger a sound alarm and display the alarm message “Sensor Off”.
Pacemaker fault: When cardiac conduction is completely blocked or the pacemaker cannot be
moved away, P wave (> 1/5 of the mean height of R wave) may be wrongly recorded by the
device, causing failure to monitor cardiac arrest.
External pacing electrode: When external pacing electrode is used on the patient’s body, the
arrhythmia monitoring quality will degrade significantly due to high energy in pacemaker
pulse. This will result in failure of the arrhythmia algorithm to detect pacemaker capture
failure or cardiac arrest.
Devices such as defibrillator and remote measurement unit will generate a filtered ECG signal.
11-1
ECG Monitoring
When this signal is used as the input signal for bedside monitor, it will be filtered again. If such
signal after second filtering is transmitted to the arrhythmia algorithm, it may cause failure to
detect such conditions as pacemaker pulse, pacemaker capture failure or cardiac arrest. This
will degrade the performance of the device when it is used for monitoring patients implanted
with pacemakers.
During defibrillation, the ECG cable connected to the patient may get damaged. To reuse such
cable, please check whether the cable function is OK.
After defibrillation, if electrodes are used correctly and are attached properly according to the
manufacturer’s instructions, the waveforms on screen display will be recovered within 5s. For
electrosurgery or defibrillation, the measurement accuracy may be reduced temporarily, but
this will not affect the safety of the patient or the device.
When the monitor is connected to an electrosurgical unit (ESU), in order to protect the patient
from injury caused by leakage current, the sensors and cables of the device should not come
into contact with the ESU.
Do not expose the monitor to X-ray and high-intensity magnetic fields.
Note
Interference from ungrounded devices near the patient and ESU interference may result in
wave problem. If the device is operated under conditions specified in EN60601-1-2 (radiation
resistance: 3V/m), electric field intensity over 1V/m may cause measurement errors at different
frequencies. Therefore, it is suggested not to use any electric radiation device in a place near
ECG/RESP measurement.
If the ECG electrode is correctly placed but the ECG wave is still inaccurate, please replace the
leads.
To protect the environment, please recycle and treat used electrode patches appropriately.
Skin is a poor conductor. Therefore, to achieve good contact between electrodes and skin, it is very important
to prepare the patient’s skin:
1) Choose a skin area without any damage or abnormality.
2) When necessary, shave body hair at positions where electrodes will be placed.
3) Use soapsuds to thoroughly clean the skin. (Do not use diethyl ether or pure alcohol because these
11-2
ECG Monitoring
5) Use skin preparation paper for ECG to gently rub the skin, so as to remove dead skin and improve the
2) Place the electrode on the patient’s body; if the electrode used does not contain conductive paste, please
4) Insert the patient cable into the ECG port on the monitor. The monitor shows the ECG wave and value.
The table below lists the names of leads in European and American standards, respectively. (RA, LA, RL, LL
and V are used to represent leads in American standards, whereas R, L, N, F and C are used in European
standards):
See the table below for marks and color codes of 3-lead and 5-lead electrodes:
U.S.A. Standard EU Standard
RA White R Red
LA Black L Brown
LL Red F Green
RL Green N Black
V Brown C White
See the table below for marks and color codes of 12-lead electrodes:
U.S.A. Standard EU Standard
RA White R Red
LA Black L Brown
RL Green N or RF Black
LL Red F Green
V1 Red C1 Red
11-3
ECG Monitoring
V2 Brown C2 Brown
V3 Green C3 Green
V4 Blue C4 Brown
V5 Orange C5 Black
V6 Purple C6 Purple
Refer to American and European standards for placing electrodes of 3-lead unit (see Fig. 11-1):
White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Red/green (left leg) electrode — Place it at the left lower abdomen
LL Red (U.S.A.)
F Green (EU)
Refer to American and European standards for placing electrodes of 5-lead unit (see Fig. 11-2):
White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Green/black (right leg) electrode — Place it at the right lower abdomen
Red/green (left leg) electrode — Place it at the left lower abdomen
Brown/white (chest) electrode — Place it on the chest wall according to Fig. 11-2.
11-4
ECG Monitoring
V Brown (U.S.A.)
C White (EU)
For 5-lead configuration, place the chest (V) lead electrode at one of the following positions (Fig. 11-3):
V1: 4th intercostal space, at the right sternal border.
V2: 4th intercostal space at the left sternal border.
V3: In the middle position between V2 and V4.
V4: 5th intercostal space at the left midclavicular line.
V5: In the left anterior axillary line, just parallel to V4.
V6: In the left midaxillary line, just parallel to V4.
V3R-V6R: On the right side of the chest wall, corresponding to
the left-side position.
VE: At the xiphoid eminence position.
V7: 5th intercostal space in the left posterior axillary line at the back.
V7R: 5th intercostal space in the right posterior axillary line at the
back.
Fig 11-3 Positions for Placing Chest Lead
Electrode of the 5 Leads
White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Green/black (right leg) electrode — Place it at the right lower abdomen
Red/green (left leg) electrode — Place it at the left lower abdomen
11-5
ECG Monitoring
Lewis
LA Black (U.S.A.)
L Yellow (EU)
RA White (U.S.A.)
R Red (EU)
There are generally six electrode positions on the chest, using intercostal gap to pinpoint the positions, V1 ~
V6:
V1: 4th intercostal space, at the right sternal border.
V2: 4th intercostal space at the left sternal border.
V3: In the middle position between C2 and C4.
V4/C4: 5th intercostal space at the left midclavicular line
V5/C5: on the left anterior axillary line, horizontal with the C4 electrode position
V6/C6: on the left midaxillary line horizontal with the V4 electrode position
Fig 11-5 Positions for Placing Chest Lead Electrode of the 12 Leads
11-6
ECG Monitoring
Warning
Use appropriate ECG cables in the OR. These cables can prevent patient burn and reduce
electronic interference through additional circuits. They are not suitable for RESP test.
When using an ESU, never place electrodes close to the earth plate of the ESU; otherwise
there will be much interference against ECG signal.
The placement of ECG lead depends on the type of operation to be performed. For example, when a
thoracotomy is to be performed, the electrode can be placed on the side of the chest or on the back. In the OR,
artifacts may affect ECG wave due to the use of an ESU. In order to reduce artifacts, the electrodes can be
placed at the left and right shoulders, close to the left and right sides of the abdomen; the chest lead can be
placed left to the middle of the chest; avoid placing the electrode on the upper arm, or the ECG wave may
become very small.
Note
To monitor a patient implanted with a pacemaker, [Pace] must be set to “On”. If it is set to
“Off”, pacemaker pulses may be counted as QRS complex, resulting in failure to detect the
cardiac arrest alarm. To change patient info or admit/discharge a patient, please check
whether [Pace] is set correctly.
When monitoring a patient implanted with a pacemaker, sometimes a part of pacemaker
pulses cannot be shielded. If pacemaker pulses are counted as QRS complex, it will result in
wrong heart rate calculated and failure to detect cardiac arrest or some arrhythmia. At this
point, close attention should be paid to the condition of the patient implanted with a
pacemaker.
ECG value
Filter mode
Gain Notch status Arrhythmia analysis
1mV scale bar Alarm limit
Lead
name
11-7
ECG Monitoring
3-lead, 5-lead and 12-Lead ECG cables apply to this monitor. ECG cables with different leads can be used to
monitor different ECG waves.
When the 3-lead ECG cable is used, leads that can be monitored include I, II and III. In the Standard interface,
ECG wave of at most 1 lead can be displayed.
When the 5-lead ECG cable is used, leads that can be monitored include I, II, III, aVR, aVL, aVF and V. In
the Standard interface, ECG wave of at most 2 leads can be displayed.
When the 12-lead ECG cable is used, leads that can be monitored include I, II, III, aVR, aVL, aVF, V1, V2,
V3, V4, V5, and V6. In the Standard interface, ECG wave of at most 2 leads can be displayed.
When the lead type of the monitor is set to Auto, the monitor will automatically judge the leads to be
monitored.
Set the lead type for the ECG cable supplied with the device:
1) Select the ECG parameter area to enter the Setup menu → [Lead Type] → [3 Leads], [5 Leads], [12
Leads] or [Auto].
When Smart Lead Off is enabled, the monitor will automatically switch the lead type between 3 Leads, 5
Leads and 12 Leads according to the current lead connection status.
Enable or disable the Lead Auto Recognition function:
1) Select the ECG parameter area to enter the SETUP menu → [Other Setup].
In the Standard interface, when 3 Leads is selected as the lead type, only one ECG wave can be displayed;
when 5 Leads or 12 Leads is selected, two ECG waves can be displayed.
1) Select the first ECG wave to enter the [ECG Wave] menu → [Lead Name]; select the lead for key
11-8
ECG Monitoring
2) If 5 Leads or 12 Leads is used, select the second ECG wave; the [ECG Wave] menu will pop up → [Lead
Name]; select the lead for key monitoring, such as lead [I].
If the wave size is too big or too small, user can change the display size of wave by gain setup; such setup will
not affect ECG signal analysis of the monitor. With the wave and the 1mv scale provided on the right side of
the wave, user can obtain the optimal wave.
1) Select one ECG wave to enter the [ECG Wave] menu → [Gain] → [×0.125], [×0.25], [×0.5], [×1], [×2],
[×4] or [Auto].
Note
When the input signal is too intensive, the wave crest may be cut off. In such case, user can
manually change the gain level of ECG wave according to the actual wave, so as to avoid
incomplete wave display.
Filter Mode: Clearer or more accurate waves can be obtained through filtering. Four filter modes are available
for selection.
In the Diagnosis mode, ECG waves displayed are those without filtering.
The Monitor mode will filter artifacts that may result in false alarms.
In the OR, the Surgery mode can reduce artifacts and interference from the ESU.
In the ST filter mode, the reflection of distortionless ECG signal ST segment of the patient being
measured can be guaranteed, and high-frequency interference signal above 40Hz, including power
frequency interference, can be filtered effectively. In this mode, user can obtain the value of ST segment
of the patient being measured by adjusting the position of ST segment analysis point. The filter mode
acts on two channels simultaneously, and is displayed above the first ECG wave.
1) Select one ECG wave to enter the [ECG Wave] menu → [Filter Mode] → [Diagnosis], [Monitor],
[Surgery] or [ST].
Warning
The system can provide unprocessed real signals only in the diagnosis mode. In the “Monitor”
and “Surgery” filter modes, the ECG wave will distort to different degrees. At this moment,
the system can only provide the basic ECG info, which will greatly affect the result of ST
11-9
ECG Monitoring
segment analysis. In the Surgery mode, the result of AWRR analysis may also be affected to
some extent. Therefore, it is suggested that the Diagnosis mode should be used for patient
monitoring when there is little interference.
User can select the leads for HR calculation and arrhythmia analysis, but should ensure the presence of the
following wave characteristics under corresponding leads:
a) Tall and narrow without notch.
11-10
ECG Monitoring
Notch filter can inhibit the 50Hz or 60Hz frequency component in the signals acquired. When the filter mode
is not Diagnosis, the system will turn on Notch Filter automatically; when the filter mode is Diagnosis, Notch
Filter can be turned on or off as needed.
1) Select the ECG parameter area to enter the Setup menu → [Other Setup]
4) User can select [50Hz] or [60Hz] according to the power supply frequency.
Select the ECG parameter area to enter the Setup menu → [Other Setup]. In the pop-up Setup menu, select
[Pacer Reject] and switch it to ―On‖ or ―Off‖.
When [Pace] is turned on:
When [Pacer Reject] is set to On, the display of pacing signal will be inhibited. However, when pacing signal
is detected, the pacemaker pulse symbol will still be displayed above the ECG wave.
When [Pacer Reject] is set to Off, the display of pacing signal will not be inhibited. When pacing signal is
detected, the pacemaker pulse symbol will be displayed above the ECG wave.
11.5.10 HR Source
User can select the HR source to determine the HR value or PR value displayed in the ECG parameter area;
the color of HR parameter value is consistent with the source parameter selected. Select the ECG parameter
area to enter [ECG Setup], and set [HR Source] as follows:
[ECG]: The ECG parameter area displays the HR value, and the monitor makes the heartbeat sound.
[SpO2]: The ECG parameter area displays the pulse rate value from SpO2, and the monitor makes the pulse
sound.
[ART], [PA], [UAP], [BAP], [FAP], [P1], [P2], [P3], [P4], [LV], [AO]: Specific pressure parameters from
IBP; display the pulse rate value from IBP. (Which pressure parameter can be selected as the source depends
on which pressure parameter is monitored by the monitor)
11-11
ECG Monitoring
When Mul. Lead Analysis is turned on, the setting of ECG [Calculate Lead] will become invalid. The module
intelligently selects the lead with good ECG wave for HR calculation
1) Select the ECG parameter area to enter the Setup menu.
11.5.12 Cascade
Cascade is for user to observe the designated realtime ECG wave for a long period of time. In the Cascade
interface, the screen will show cascade wave of the same lead. Currently the monitor is in any work interface
under the multi-parameter monitoring mode; select ECG in the waveform area; in the pop-up [ECG Wave]
menu, turn on [Cascade]. The number of cascade waves displayed depends on the number of ECG waves
present in the current interface. The operation over one of the ECG waves also applies to other ECG waves.
Note
Under the interface of [12-Lead ECG] and [7-Lead Half Screen], [cascade] is not optional.
Normal heartbeat and atrial pacing heartbeat are used in ST segment analysis. The monitor analyzes these
heartbeats and calculates the elevation and depression of ST segment. On the monitor, the info can be
displayed as ST value. All available leads can be monitored continuously. For ST segment analysis, it is
unnecessary to display ECG wave on the monitor. For ST segment analysis, special filter that can ensure the
diagnosis quality should be used during execution. If you use an ECG filter mode other than [Diagnosis] filter
to monitor ECG; the ST segment of ECG wave may be slightly different in appearance from the ST segment
of ST fragment having the same waveform. To perform diagnostic assessment of ST segment, please always
switch to the [Diagnosis] filter mode. You can also select the [Monitor] or [Surgery] mode, but ST segment
data will be distorted seriously.
ST segment analysis can measure the elevation or depression of ST segment on the designated lead.
Meaning of ST segment measurement value: A positive number represents elevation; a negative number
represents depression.
ST segment measurement range: -2.0 ~ +2.0mV.
11-12
ECG Monitoring
Some clinical situations may result in difficulty to achieve reliable ST monitoring. For example:
Lead of low noise cannot be obtained.
Presence of arrhythmia (e.g., atrial fibrillation/atrial flutter) that can cause irregular baseline.
Warning
This monitor provides info about changes in ST level, the clinical significance of which should
be determined by the doctor.
1) Select the ECG parameter area to enter the Setup menu → [ST Analysis].
Set the reference point of ST measurement point as R wave crest point; the ST measurement value of the
complex wave of each heartbeat is the vertical distance difference between the wave crest point and the two
measuring points. See the figure below:
R wave
J Difference= ST value
The ST measurement value of the complex wave of each heartbeat is the vertical distance between the
intersections of the wave and the two measuring points.
11-13
ECG Monitoring
Note
If the HR or ECG wave of the patient changes obviously, the position of ISO and ST points
should be adjusted. During ST segment analysis, abnormal QRS complex is not considered.
Please ensure that the position of ST measuring point is suitable for the patient being
monitored.
3) Select [Adjust ST Point] to enter the [ST Analysis] window: three vertical lines are ISO, J and ST,
respectively.
4) Select the appropriate ST measurement lead; select [ST Lead] to switch the measurement lead.
The cursor position of ISO point is related to R wave crest equipotential. Use to locate the ISO
point in the middle of the flattest position of baseline (between P and Q waves or in front of P wave).
The cursor position of J point decides the relative position of J point and R wave crest. This can help user
to correctly locate the ST point. Use to place J point at the end of QRS complex and the beginning
of ST segment.
Locate ST point:
Select J+60, J+80 or J+40 to convert the value and move J point to locate ST point in the middle of ST
segment.
6) When setting is finished, select ― ‖ to exit the window.
This monitor can save 20 groups of ST analysis fragments for reference and review. A ST analysis fragment
shows a complete QRS wave fragment of all ST leads. Reference data stored are drawn in white; realtime data
are drawn in green. Realtime data of ST segment are refreshed every 5s.
Enter [ST Analysis Review]:
1) Select the ECG parameter area to enter the Setup menu → [ST Analysis]; open [ST Analysis] → [ST
Analysis Review].
11-14
ECG Monitoring
To save the current ST fragment as the reference fragment, select [Save Ref.] (Save Reference).
To delete the current reference fragment displayed, select [Del Ref] (Delete Reference).
11.6.6 ST Alarm
Select the ECG parameter area to enter the Setup menu → [ST Analysis]; open [ST Analysis] → [Alarm
Limit Setup] to perform parameter alarm setup; the monitor sets alarm limits for each lead. For operation
details, see the ―Alarm‖ chapter.
Arrhythmia analysis is clinically used in patient ECG monitoring to detect HR changes and premature
ventricular contractions, save arrhythmia events and generate alarm messages. Arrhythmia analysis can be
used for monitoring patients implanted or not implanted with pacemakers. The doctor can evaluate the
patient’s condition (e.g., HR, PVCs (premature ventricular contractions) frequency, rhythm and abnormal
heartbeat) according to arrhythmia analysis, and carry out diagnosis and treatment on this basis. Apart from
detection of ECG changes, arrhythmia analysis can monitor the patient and give proper alarms.
The arrhythmia monitoring function of the monitor is Off by default. User can enable this function as needed.
11-15
ECG Monitoring
The arrhythmia monitoring function can, through testing and classifying arrhythmia and abnormal heartbeat,
remind the doctor of paying attention to the patient’s heart rhythm and generate alarms.
This monitor can analyze 26 types of arrhythmia.
1) Select the ECG parameter area to enter the Setup menu → [ARR Analysis].
1) Select the ECG parameter area to enter the Setup menu → [ARR Analysis].
3) Select [Alarm Setup] to enter the [ARR Analysis - Alarm Setup] window; user can perform restoration
setup, alarm on/off setup, alarm level and record on/off setup for [Asystole], [V-fib], [R ON T], [VT>2],
(Bradycardia), [PNC] (Pacer Not Capture), [PNP] (Pacer Not Pace), [Missed Beats], [IHB] (Irregular
Heart Beat), [VTAC] (Ventricular Tachycardia), [Tachy] (Tachycardia), [PVCs Too High], [Extreme
[Atrial Fibrillation] and [Pause/min]. Select [Restore] to restore the device to factory settings.
NOTE: The alarm level and alarm on/off status of [Asystole], [V-fib], [VTAC], [Extreme Tachycardia],
[Extreme Bradycardia] and [Vent. Brady] are in default, which cannot be changed by the user.
Select [ECG] in the parameter area; in the pop-up [ECG Setup] menu, enter the [ARR Analysis] menu, where
user can set the threshold of each arrhythmia type. Parameters can be set in the following ranges:
No. Arrhythmia Type Setup Range Default Value Step Unit
1 PVCs 0-31 10 1 PCS
2 Tachycardia 60-300 ADU: 120 1 bpm
NEO/PED: 160
3 Extreme 60-300 ADU: 160 1 bpm
Tachycardia PED: 180
NEO: 200
4 Extreme 15-120 ADU: 40 1 bpm
Bradycardia PED: 50
11-16
ECG Monitoring
During ECG monitoring, when the ECG template of the patient changes significantly, user may need to start
an ARR Relearn process. ARR Relearn enables the monitor to learn new ECG templates, thus to correct
arrhythmia alarms and heart rhythm values.
1) Select the ECG parameter area to enter the Setup menu → [ARR Analysis].
2) Select [ARR Relearn]; the system will give the prompt message [ARR Learning].
User can also directly select the [ARR Relearn] quick key.
11.8 RR Intervals
The normal ECG waveform will not change much at RR intervals. However, when abnormal situation occurs
on the ECG of patients, the change at RR intervals would be obvious. This monitor will record the change at
RR intervals while monitoring the ECG of patients. Having monitored the ECG of patients, this monitor will
provide the maximum, average, minimum and standard deviation of the change at RR intervals to doctors for
judgement.
During ECG monitoring, if the patient’s ECG template changes significantly, you may need to manually start
an ECG Relearn process. Changes in the ECG template may result in:
11-17
ECG Monitoring
Inaccurate HR value
Start relearning:
Select the ECG parameter area to enter the Setup menu → [Other Setup] → [Relearn].
Caution
Please start ECG Relearn during normal rhythm and when ECG signal is relatively noiseless.
This is because ECG Relearn during the arrhythmia period may result in relearning the wrong
QRS complex as the ECG template.
The Defibrillation Synchronization function is to output +5V defibrillation synchronization signal during
100ms via the multi-function port every time the monitor detects R wave; such signal is for use by the
defibrillator. The Defibrillation Synchronization function of the monitor is always on.
Warning
Improper use of the defibrillation function may cause injury to the patient; user should judge
whether defibrillation is necessary or not according to the patient’s actual condition.
Prior to defibrillation, user should ensure that the defibrillator and the monitor have
undergone system test and these two devices can work in conjunction with each other safely
and effectively.
Prior to defibrillation, user should set the filter mode to [Diagnosis].
At the end of defibrillation, user can select the filter mode as needed.
11-18
Chapter 12 Resp Monitoring
The Monitor measures the RESP based on the thoracic impedance between the two electrodes. The changes of
such impedance caused by thoracic movements will generate a RESP wave on the screen. The RR is
calculated from such wave.
In Resp measurement, it is important to prepare the skin properly for electrode placement. Refer to the
relevant section on ECG measurement.
The Resp signals are measured through the two ECG electrodes. In case of standard placement of ECG
electrodes, the Resp can be measured through the electrode RA and electrode LL.
To measure the ECG and Resp simultaneously, it may be necessary to adjust the positions of the two
electrodes for some patients. Non-standard placement of ECG electrodes may cause changes to the ECG
waveform and affect the ST segment analysis and ARR analysis.
1) Cardiac Superposition
The cardiac activities affecting the Resp waveform are defined as cardiac superposition, which occurs when
the electrodes acquire the impedance changes caused by rhythmic blood flow. Proper placement of electrodes
can reduce cardiac superposition and protect the liver area and ventricles against the cable between the
electrodes, which is especially important to neonates.
2) Lateral Thoracic Expansion
The thoracic cage of some patients, especially neonates, may expand to both sides. To achieve the best Resp
waveform, please place the two electrodes respectively at the right mid-axillary line and left outer chest with
strongest Resp movements as shown below:
12-1
Resp Monitoring
3) Abdominal Respiration
Some patients may have restricted thoracic movements and rely mainly on abdominal respiration. To achieve
the best Resp waveform, please place the electrode LL on the left abdomen with strongest expansion as shown
below:
3) In [Manual] mode, you can set the upper and lower dotted line of the Resp waveform.
4) In [Auto] mode, you cannot change the upper or lower dotted line but use the default waveform
calculation method.
[Auto] mode:
The Monitor auto adjusts the detection level based on the waveform height and ECG artifact. In [Auto] mode,
no dotted line of detection level is displayed on the Resp waveform.
Please select [Auto] mode if:
The RR is not approximate to the HR;
12-2
Resp Monitoring
[Manual] mode:
In [Manual] mode, you have to set the Resp detection level. The Monitor does not auto adjust the dotted lines
of detection level. When the Resp depth changes or the Resp waveform gain is adjusted, you may need to
adjust the position of the dotted lines of detection level on the Resp waveform manually by selecting [Up Line]
and [Down Line].
Please select [Manual] mode if:
The RR is approximate to the HR;
The Resp signals are weak (try to improve the signal quality by relocating the electrodes).
In [Manual] mode, the superposition of some cardiac activities may trigger the Resp counter and result in
incorrect high RR indication or no-breath detection failure. If you doubt that the cardiac superposition has
been treated as Resp activities, improve the RESP detection level until it is higher than the cardiac
superposition. If you fail to improve the Resp detection level due to small Resp waveform size, follow
Subparagraph 2) Lateral Thoracic Expansion of Section 12.2.1 Optimization of Lead Position to optimize the
position of the electrodes.
12.5.1 Gain
Gain is used to adjust the amplitude of the Resp wave. You can select ×0.25, ×0.5, ×1, ×2 or ×4 as the gain.
1) Select the Resp parameter area to enter [Resp Setup] and select an appropriate [Gain].
No-breath detection is to detect the longest interval between two adjacent RESPs. When the actual no-breath
time of the patient exceeds the set no-breath time, the Monitor will respond to no-breath alarms according to
the value of [No Breath Alm Delay].
Set [No Breaths Timeout]:
1) Select the Resp parameter area to enter [Reso Setup] → [No Breaths Timeout] and set an appropriate
detection time.
Set [No Breath Alm Delay]:
1) Enter [User Maintain] → [Other Setup].
2) Set [No Breath Alm Delay] to [Off], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or
[1min].
If you select [Off], the alarm delay function will be disabled.
12-3
Resp Monitoring
Resp leads indicate the source of the current Resp waveform. You can set [Resp Lead] to RA-LA (I), RA-LL
(II) or [Auto]. If you select [Auto], the Monitor will auto select an appropriate Resp lead.
1) Select the Resp parameter area to enter [Resp Setup] → [Resp Lead].
This parameter is designed to filter out the Resp interference. Its default is [On].
1) Select the Resp wave area to enter [Resp Wave].
Note
In Resp measurement, the Monitor cannot recognize any obstructive or mixed no-breath but
trigger an alarm when the interval between two adjacent RESPs exceeds the set time.
12-4
Chapter 13 SpO2 Monitoring
13.1 Overview
The SpO2 plethysmography measures the arterial SpO2, namely, the percentage of the oxyhemoglobin count.
The SpO2 is measured with the pulse oximetry, a continuous noninvasive method measuring how many of the
lights emitted from the sensor (light source) can penetrate the patient’s tissues (fingers or ears) and reach the
receiver.
The Monitor measures the following parameters:
Arterial SpO2: the ratio of the oxyhemoglobin to the sum of oxyhemoglobin and non-oxygenated hemoglobin
(functional arterial SpO2);
Pleth waveform: a visible indication of the patient’s pulse;
PR (calculated from pleth waveform): the patient’s pulse count per minute;
PI (perfusion index, not for Nellcor SpO2): pulse signal strength as the percentage of pulsatile signal to non-
pulsatile signal.
Warning
If there is any carboxyhemoglobin (COHb), methemoglobin (MetHb) or dye dilution
chemical, the SpO2 value will have a deviation.
The SpO2 sensor type is pre-configured before the Monitor is delivered. You can identify it based on the
silkscreened logo beside the original SpO2 sensor below the sensor interface on the left side of the Monitor:
Standard SpO2 sensor:
Sensor interface: circular interface at the center of the side panel;
Silkscreened logo: SpO2.
Masimo SpO2 sensor:
Sensor interface: square interface at the bottom of the side panel;
Silkscreened logo: .
13-1
SpO2 Monitoring
The Standard SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).
The Masimo SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).
The Nellcor SpO2 sensor can measure a wavelength of 660nm (red LED) or 900nm (IR LED).
The maximum optical output power of the sensor is lower than 15mW.
Warning
The Monitor can auto recognize the SpO2 sensor type. However, it will fail to measure the
SpO2 properly if you use a sensor incompatible with its internal hardware.
Warning
The Monitor is compatible with the SpO2 sensor designated by our company only.
Before monitoring the patient, please check if the sensor and extension cord are compatible with
the Monitor. Incompatible accessories may reduce the performance of the Monitor.
Before monitoring the patient, please check if the sensor cable works properly. Remove the
SpO2 sensor cable from the sensor interface, and the Monitor will display the prompt message
“SpO2 sensor off” and trigger the alarm sound.
If the SpO2 sensor or its package seems damaged, do not use it but return it to the
manufacturer.
Long-time continuous monitoring may increase the risk of undesired skin characteristic changes
(extremely sensitive, turning red, blistered or pressure necrosis), especially for neonates or the
patients with perfusion disorder or variable or immature skin morphology diagram. Align the
sensor with the light path, fix it properly and check its position regularly based on skin quality
changes (change the sensor position in case of reduced skin quality). Perform such check more
frequently if necessary (subject to the condition of the patient).
Make sure the sensor cable and electrosurgical equipment cable are not intertwined.
Do not place the sensor on a limb with ductus arteriosus or intravenous tube.
Setting the upper SpO2 alarm limit to 100% will disable the upper-limit alarm. Premature
infants may get infected with crystalline posterior fibrous tissue diseases in case of high SpO2.
Please set the upper SpO2 alarm limit cautiously based on recognized clinical practices.
The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
Do not place the pulse oximeter or accessories in any position that might cause it to fall on the
patient.
13-2
SpO2 Monitoring
Do not start or operate the pulse oximeter unless the setup was verified to be correct.
Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI
environment.
Do not use the pulse oximeter if it appears or is suspected to be damaged.
Explosion hazard: Do not use the pulse oximeter in the presence of flammable anesthetics or
other flammable substance in combination with air, oxygen-enriched environments, or nitrous
oxide.
To ensure safety, avoid stacking multiple devices or placing anything on the device during
operation.
To protect against injury, follow the directions below:
Avoid placing the device on surfaces with visible liquid spills.
Do not soak or immerse the device in liquids.
Do not attempt to sterilize the device.
Use cleaning solutions only as instructed in this operator's manual.
Do not attempt to clean the device while monitoring a patient.
To protect from electric shock, always remove the sensor and completely disconnect the pulse
oximeter before bathing the patient.
If any measurement seems questionable, first check the patient’s vital signs by alternate means
and then check the pulse oximeter for proper functioning.
Inaccurate SpO2 readings may be caused by:
Improper sensor application and placement
Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
Elevated levels of bilirubin
Elevated levels of dyshemoglobin
Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell,
etc.
Hypocapnic or hypercapnic conditions
Severe anemia
Very low arterial perfusion
Extreme motion artifact
Abnormal venous pulsation or venous constriction
Severe vasoconstriction or hypothermia
Arterial catheters and intra-aortic balloon
Intravascular dyes, such as indocyanine green or methylene blue
Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers.
13-3
SpO2 Monitoring
etc.
Skin color disorders
Interfering Substances: Dyes or any substance containing dyes that change usual blood
pigmentation may cause erroneous readings.
The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in
conjunction with clinical signs and symptoms.
The pulse oximeter is not an apnea monitor.
The pulse oximeter may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
The pulse oximeter may be used during electrocautery, but this may affect the accuracy or
availability of the parameters and measurements.
The pulse oximeter should not be used for arrhythmia analysis.
SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
Do not adjust, repair, open, disassemble, or modify the pulse oximeter or accessories. Injury to
personnel or equipment damage could occur. Return the pulse oximeter for servicing if
necessary.
Cautions
Do not place the pulse oximeter where the controls can be changed by the patient.
Electrical shock and flammability hazard: Before cleaning, always turn off the device and
disconnect from any power source.
When patients are undergoing photodynamic therapy they may be sensitive to light sources.
Pulse oximetry may be used only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.
Do not place the pulse oximeter on electrical equipment that may affect the device, preventing it
from working properly.
If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the
patient’s condition.
If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If
the sensor is exposed to the radiation, the reading might be inaccurate or the device might read
zero for the duration of the active irradiation period.
To ensure that alarm limits are appropriate for the patient being monitored, check the limits
each time the pulse oximeter is used.
Variation in measurements may be profound and may be affected by sampling technique as well
as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s
clinical status should be repeated and/or supplemented with additional test data. Blood samples
should be analyzed by laboratory instruments prior to clinical decision making to completely
13-4
SpO2 Monitoring
Notes
A functional tester cannot be used to assess the accuracy of the pulse oximeter.
High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not
allow the pulse oximeter to obtain vital sign readings.
Cautions
If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In
the interim, assess the patient and, if indicated, verify oxygenation status through other means.
Change the application site or replace the sensor and/or patient cable when a “Replace sensor”
and/or “Replace patient cable”, or a persistent poor signal quality message (such as “Low SIQ”)
is displayed on the host monitor. These messages may indicate that patient monitoring time is
exhausted on the patient cable or sensor.
Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently
displayed while monitoring consecutive patients after completing troubleshooting steps listed in
this manual.
Notes
When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be
compromised. If the device is in this setting and the sensor becomes dislodged from the patient,
13-5
SpO2 Monitoring
the potential for false readings may occur due to environmental "noise" such as light, vibration,
and excessive air movement.
Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the
patient cabling.
Additional information specific to the Masimo sensors compatible with the pulse oximeter,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).
Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate
readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the
specified duration of the patient monitoring time.
Warning
The function tester cannot be used to assess the accuracy of the SpO2 sensor.
Assess the SpO2 accuracy by comparing the readings respectively on the Monitor and CO-oxygen pressure
gauge.
This monitor can measure low perfusion and the recommended method of determining the low perfusion
accuracy of the monitor is to conduct this test with CO-oximeter on adult volunteers whose SpO2 ranges from
70% to 100%. The accuracy index is obtained according to statistical distribution, and only about 2/3 of the
estimated values are expected to fall within the estimated values of CO-oximeter.
Warning
Place the SpO2 sensor properly based on the SpO2 sensor type compatible with the Monitor.
This is especially important for neonates.
13-6
SpO2 Monitoring
SpO2 plethysmography:
2) Insert the SpO2 cable connector into the SpO2 interface of the Monitor;
13-7
SpO2 Monitoring
In operations, the following factors may affect the SpO2 measurement accuracy:
1) High-frequency radio interference, whether from the host system or from the electrosurgical
equipments connected to the host system. To minimize radio interference, other electrical equipment
that emits radiofrequency transmissions should not be in close proximity to the instrument.
2) Do not use the oximeter or SpO2 sensor in the MRI process, or the induced current may cause burns.
3) Intravenous dyes.
8) The sensor is placed on a limb with blood pressure cuff, ductus arteriosus or intravenous tube.
12) The shock, anemia, hypothermia and application of vasoconstrictors may reduce the arterial blood flow
to a non-measurable level.
13) The SpO2 measurement accuracy depends also on the absorption of the lights with special wavelength by
oxyhemoglobin and reduced hemoglobin. If any other substance also absorbs such lights, like COHb,
MetHb, methylene blue or indigo carmine, you may obtain a false or low SpO2 value.
13-8
SpO2 Monitoring
Enter [User Maintain] → [Alarm Setup] → [SpO2 Sensor Lead Off Level].
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Sat second] (Saturation Seconds).
13-9
SpO2 Monitoring
About 4.9s later, the Monitor will report a Sat second alarm because you’ve set [Sat second] to [50], smaller
than 54.
The SpO2 value may fluctuate in seconds rather than remain unchanged. The patient’s SpO2 value usually
fluctuates within the alarm limit and sometimes goes beyond the alarm limit discontinuously. The Monitor
will accumulate the positive and negative percentage points until the set value of [Sat second] is reached or
the patient’s SpO2 value remains beyond the alarm limit.
You will (will not) hear the pulse tone in case of unstable signal or ambient noise if this function is enabled
(disabled).
Set [Smart Tone]:
1) Select the SpO2 parameter area to enter [SpO2 Setup].
13.8.5 Signal IQ
If this function is enabled and the displayed SpO2 value is not based on an appropriate signal quality, the
Monitor will display a visible plethysmogram indicating the measurement signal quality and the patient’s
pulse events.
Movements usually affect the signal quality. When the arterial pulse reaches the peak, the Monitor will mark
its location on the vertical line (signal indicator). The volume of the smart tone (if enabled) remains consistent
with the vertical line (the volume of the smart tone will increase or decrease accordingly when the SpO2 value
increases or decreases).
The height of the vertical line represents the quality of the measured signal (the higher line, the higher quality).
Set [Signal IQ] (Signal Identification and Quality):
1) Select the SpO2 parameter area to enter [SpO2 Setup].
13-10
SpO2 Monitoring
The SpO2 value displayed on the Monitor is the average of the SpO2 values acquired in a given time. Shorter
(longer) average time will lead to quicker (slower) response and lower (higher) measurement accuracy of the
Monitor when the patient’s SpO2 value changes. For a critical patient, please set a short average time so as to
analyze his/her condition timely. Set [Average Time]:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Average Time].
If this function is enabled, the Monitor will perform the SpO2 measurement as fast as [Average Time] is set to
[2-4s].
1) Select the SpO2 parameter area to enter [SpO2 Setup].
2) Select [Fast Sat] (Fast Saturation) to switch between [On] and [Off].
Note: this function is available for Masimo SpO2 only; if this function is enabled, you can find the
prompt message “Fast Sat” at the main interface.
13.8.8 Sensitivity
[Sensitivity] can be set to [Normal], [Maximum] or [APOD] (Adaptive Probe Off Detection). [APOD]
represents the highest sensitivity. In typical monitoring conditions, please select [Normal]. If the sensor is
likely to come off the patient due to wet skin, violent movements or other causes, please select [Maximum]. If
the patient’s perfusion level is extremely low, please select [APOD].
Set [Sensitivity]:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Sensitivity].
13-11
SpO2 Monitoring
13-12
Chapter 14 NIBP Monitoring
14.1 Overview
The Monitor uses the vibration method (measure the cuff pressure vibration amplitude) to measure the
noninvasive blood pressure (NIBP). Blood pressure changes will cause cuff vibrations. The cuff pressure at
the highest vibration amplitude is the mean pressure. The systolic pressure and diastolic pressure are
calculated from the mean pressure.
NIBP measurement is applicable in electrosurgical operations and defibrillator discharges according to
IEC601-2-30/EN60601-2-30.
NIBP monitoring is applicable to adults, children, neonates, pregnant women and preeclampsia patients.
Warning
Before the NIBP measurement, make sure the selected monitoring mode is appropriate for the
patient (adult, child or neonate). It is dangerous to select a non-neonatal mode for neonatal
patients.
Do not place the cuff on a limb with intravenous tube or cannula, or the tissues around the
cannula may be damaged when the infusion is slowed or blocked in the cuff inflation process.
Make sure the inflation tube connecting the blood pressure cuff to the Monitor is not
obstructed or tangled.
Do not perform the NIBP measurement to a patient with sickle cell disease or existing or
expected skin lesions.
For a patient with severe disturbances of blood coagulation, please determine the applicability
of automatic NIBP measurement based on clinical evaluation, or the limb contacting the cuff
may suffer from hematoma due to friction.
Frequent measurements may cause blood flow interference and injure the patient.
To prevent further injury, do not place the cuff on any wound.
Do not place the blood pressure cuff on a limb under intravenous infusion, intravenous therapy
or arteriovenous shunt, or the transient blood flow interference will injure the patient.
Do not place the cuff on the arm at the same side as mastectomy.
The increasing cuff pressure may cause transient function failure to other monitoring
equipment used on the same limb.
14-1
NIBP Monitoring
2) Connect the inflation tube to the NIBP interface of the Monitor without compressing or blocking the
pressure tube.
3) Use a cuff of the correct size and make sure the airbag is not folded or twisted.
An incorrect cuff size or a folded or twisted airbag will cause inaccurate measurement. Make sure
the cuff is deflated thoroughly. The cuff width should be 40% (50% for neonates) of the limb
perimeter or 2/3 of the upper arm length. The inflated part of the cuff should be long enough to
4) Tie the cuff around the limb and make sure the cuff is at the same level as the patient’s heart. If you fail
Make sure the mark ―φ‖ is located at an appropriate artery. Do not tie the cuff too tightly, or the
distal extremity may suffer from discoloration or ischemia. Check the skin condition of the contact
part and the color, temperature and feeling of the limb wearing the cuff regularly. If the skin
condition changes or the blood circulation of the limb is affected, move the cuff to another body part
for continued measurement or stop the NIBP measurement immediately. In auto measurement mode,
If the cuff is not at the same level as the heart, use the following correction formulas:
If the cuff is at a higher level than the heart: displayed NIBP value + 0.75mmHg (0.10kPa) ×
14-2
NIBP Monitoring
If the cuff is at a lower level than the heart: displayed NIBP value - 0.75mmHg (0.10kPa) × level
difference (cm).
Reusable cuff for neonates/children/adults:
The vibration method has some restrictions, depending on the patient’s condition. It detects the regular pulse
wave generated by arterial pressure. If the patient’s condition makes it difficult to detect such wave, the
measured pressure value will be unreliable and the pressure measurement time will be increased. In the
following cases, the vibration method will be disturbed, causing unreliable or impossible pressure
measurement or increased pressure measurement time, depending on the patient’s condition.
1) Patient Movements
If the patient is moving, trembling or under cramps, which may disturb the detection of arterial pressure pulse,
the NIBP measurement will be unreliable or impossible and the pressure measurement time will be increased.
14-3
NIBP Monitoring
2) Arrhythmia
If the patient has irregular heart beats due to arrhythmia, the NIBP measurement will be unreliable or
impossible and the pressure measurement time will be increased.
3) Heart-lung Machine
Do not perform the NIBP measurement if the patient is connected to a heart-lung machine.
4) Pressure Changes
If the patient’s blood pressure changes rapidly within a certain time when the Monitor analyzes the arterial
pressure pulse for measurement purpose, the NIBP measurement will be unreliable or impossible.
5) Severe Shock
If the patient is under severe shock or hypothermia, the NIBP measurement will be unreliable as the reduced
blood flowing to the periphery will reduce the arterial pulse.
6) Beyond-limit HR
Do not perform the NIBP measurement if the HR is lower than 40bpm (beats per minute) or higher than
240bpm.
7) Fat Patient
Damped by the thick fat layers of the limb, the vibration from the artery will fail to reach the cuff, causing
lower measurement accuracy than in normal cases.
8) Patient with Hypertension
To measure the NIBP of a patient with hypertension accurately, please:
Adjust his/her sitting posture until:
He/she leans his/her back against the chair and puts his/her hands on the desk;
The middle part of the cuff is at the same level as his/her right atrium.
Ask he/she relaxes as much as possible and not talk during the measurement procedure.
14-4
NIBP Monitoring
Select the NIBP parameter area to enter the setup menu →[Measure Mode]→[Manual]. Whether to start the
NIBP measure depends on the user’s need.
1. Select the NIBP parameter area to enter the setup menu→ [Whole point Mea.], and switch it to ―On‖.
2. Select the ― ‖ key on the control panel or [NIBP Start] shortcut keys and manually start the first
measure. After the first measure, the monitor will automatically and repeatedly start the measure
Note
The monitor operate the [Whole point Mea.] only when the [Interval] is not less than 5min.
Users can select all options except for the [Manual] by using short keys of [Model Setup] .Then select the
― ‖ key on the control panel or the short keys of [NIBP Start] to start the first measure. After the first
measure, the monitor will automatically and repeatedly start the measure according to the interval time set
before. Or start the interval measure following the steps below:
1. Select the NIBP parameter area to enter the setup menu →[Measure Mode]→[Auto].
3. Select the ― ‖ key on the control panel or [NIBP Start] shortcut keys and manually start the first
measure. After the first measure, the monitor will automatically and repeatedly start the measure
Select the NIBP parameter area to enter [NIBP Setup] → [Interval], select 1min~720min for interval, then the
measure mode is changed to [Auto] automatically, and start the measurement. When the measurement is over,
the monitor will start measurement after the interval you set automatically and repeatedly.
14-5
NIBP Monitoring
Select the NIBP parameter area to enter [NIBP Setup] → [Continual Measure], then start the 5min
measurement continuously.
Note
If you have any doubt about the reading accuracy, check the patient’s vital signs first with the
same method as checking the Monitor’s functions.
In order not to injure the patient, the [Continual Measure] mode will not be available if the
patient type is [Neo].
The auto measurement results are affected by the temperature, RH and altitude limit.
Warning
If any liquid splashes onto the Monitor or its accessories, especially when it is likely to flow
into the Monitor or its tubes, please contact the maintenance department of the hospital.
Finished the measurement, the monitor will emission the gas and stop the measurement. During the
measurement, you can press the ― ‖ key on the control panel or [NIBP Start] quick key to stop the
measurement.
The NIBP measurement results are displayed in the parameter area. The figure below is for reference only.
The actual display interface of the Monitor may be slightly different from this figure.
② ⑦ ③ ④
⑤
①
⑧
⑥
14-6
NIBP Monitoring
The patient type includes adult, child and neonate. Please select an appropriate measurement mode based on
the value of [PAT Type] in [Patient Info].
1) Select the NIBP parameter area to enter [NIBP Setup] → [PAT Type].
1) Select the NIBP parameter area to enter [NIBP Setup] → [Initial Pressure].
Select [NIBP] in the parameter area to enter [NIBP Setup] → [Reset]. This function can restore the initial
pressure of the blood pressure pump. If the blood pressure pump works improperly, use this function to check
it and recover its accidental exceptions.
Inflate the NIBP cuff to a pressure approximate to the diastolic pressure to block the vein vessel and assist in
the completion of venipuncture.
1) Select the NIBP parameter area to enter [NIBP Setup] → [Other Setup] → [Cuff Pressure] and then
4) Press the ― ‖ key or the relevant shortcut key to deflate the cuff. If you fail to do so, the cuff will be
14-7
NIBP Monitoring
At the NIBP analysis interface, you can view the patient’s normal values of systolic pressure and diastolic
pressure, the percentage of higher/lower values and the average, maximum and minimum systolic pressure
and diastolic pressure within the measurement time.
1) Select the NIBP parameter area to enter [NIBP Setup] → [Other Setup] → [NIBP Analysis].
Then you can set the following parameters:
[Daily Start Time]: set the NIBP data statistics starting time (hour or minute).
[Daily End Time]: set the NIBP data statistics ending time (hour or minute).
[SYS Nor. Range]: set the upper and lower limit of systolic pressure.
[DIA Nor. Range]: set the upper and lower limit of diastolic pressure.
14-8
Chapter 15 Temp Monitoring
The Monitor has two Temp measurement channels and uses a TEMP sensor to measure the Temp.
Place the Temp sensor under the patient’s armpit or on the patient’s anorectal part, depending on the sensor
type. To achieve an accurate measurement result, please measure the Temp for at least 1min.
3) Connect the Tempsensor or Temp cable to the Temp sensor interface of the Monitor.
Warning
Work mode of the Temp sensor: immediate mode.
Before the Temp measurement, check if the Temp sensor cable is in good condition. Remove the
Temp sensor cable from the Temp sensor interface, and the Monitor will display the prompt
message “T1 (T2) sensor off” and trigger the alarm sound.
Handle the Temp sensor and cable with caution. When they are idle, coil them loosely. Tight coiling
may cause mechanical damage to the cable.
Calibrate the Temp measurement set at least every two years or as required by the hospital’s
procedures. Contact the manufacturer for calibration when necessary.
Note
Do not reuse any disposable Temp sensor.
In the monitoring process, the Temp measurement set will auto perform a 2min self-test on an
hourly basis without affecting the Monitor’s normal work.
The parameter area will display the Temp value and unit of channel [T1] and [T2] and the Temp difference
[TD] between the channels. Select [Temp] in the parameter area to enter [Temp Setup].
15-1
Temp Monitoring
Temp Unit
Alarm Limit
15-2
Chapter 16 IBP Monitoring
16.1 Overview
The Monitor can measure the artery pressure (systolic pressure, diastolic pressure and mean pressure) directly.
Call up the two-channel IBP waveform (see the figure below):
Warning
Use the accessories compliant with the safety requirements on medical equipment only.
Do not touch the metal parts connected to electrical equipment when connecting or using any
accessory.
In order not to cause burns (resulted from electric leakage) to the patient, please do not allow
its sensors and sensor cables to contact such equipment when connecting the Monitor to any
high-frequency electrosurgical equipment.
Never reuse the disposable pressure sensor.
Before monitoring the patient, please check if the sensor cable works properly. Remove the IBP
sensor cable from the sensor interface, and the Monitor will display the prompt message “IBP
sensor off” and trigger the alarm sound.
If any liquid other than the solution used for the perfusion pressure tube or sensor splashes onto
the Monitor or its accessories, especially when it is likely to flow into the Monitor or its sensors,
please contact the maintenance department of the hospital.
Note
Use the pressure sensor specified herein only.
With the protection against electric shock and against the effects of defibrillators, the pressure sensor specified
herein can be used for surgical operations. The pressure waves may become disordered in the defibrillation
16-1
IBP Monitoring
process. Once the defibrillation is completed, the Monitor will go back to normal work with its operation
mode and user configurations remaining unaffected.
Note
Calibrate the sensor, whether new or used, regularly according to the relevant procedures of
the hospital.
Zero the transducer before monitoring the patient. In the IBP monitoring process, keep the
pressure sensor at the same level as the patient’s heart. In order not to clog the cannula,
irrigate the cannula with continuously fed heparin saline to keep the pressure measurement
path unobstructed. Secure the cannula reliably against displacement and disconnection and
ensure normal IBP measurement.
1) Prepare the pressure tube and sensor by filling the cannula system with the physiological saline solution.
2) Connect the patient cannula to the pressure tube. Make sure there is no air in the cannula, pressure tube
or sensor.
3) Insert the cable into the relevant socket and check if the Monitor is powered on.
5) Enter the general interface of the Monitor and select [Screen Layout] to call up the IBP waveform and
parameter to be monitored (skip this step if the IBP waveform and parameter are already displayed on the
screen).
6) Place the sensor at the same level as the heart (approximately at the mid-axillary line).
7) Zero the sensor and then close its atmosphere channel and open its patient channel.
Warning
If there is any bubble in the pressure tube or sensor, use the heparin saline to irrigate the
system. Bubbles will lead to inaccurate measurement results.
To perform the ICP measurement to a sitting patient, please adjust the sensor to the same level
as the patient’s ears. Incorrect sensor position will lead to inaccurate measurement results.
16-2
IBP Monitoring
Anticoagulant Saline
Pressure
Sensor
Valve Three-way Cock
Monitor
To prevent inaccurate measurement, please zero the sensor on a daily basis or as required by the relevant
policies of the hospital. Zero the sensor:
When using a new pressure tube or sensor;
3) Select the IBP parameter area (either displayed channel) to enter [IBP Setup] and select [Zero] (the
zeroing result will be displayed when the zeroing operation is completed). You can also select [IBP
Zero] (shortcut key) in the lower menu bar to zero the sensor.
4) Once the sensor is zeroed successfully, close its atmosphere channel and open its patient channel.
Select [IBPx: XXX] in the waveform area: ―x‖ refers to the IBP channel and ―XXX‖ refers to the current
pressure name of such channel. Select [IBPx: XXX] to set channel x.
Enter [Screen Config] to change the pressure name (select an appropriate pressure name from the table below).
16-3
IBP Monitoring
Ao Aortic pressure
Follow the steps below to enable the Monitor to display a two-parameter waveform in the IBP waveform area:
1) Enter [Main Menu] → [Screen Config] → [Screen Layout].
2) Select [IBP Waveform] and then select the two monitored IBP parameters.
1) The two channels of the sensor use the same filter mode. Select the waveform of either channel to enter
[IBPx: XXX Waveform] and then set [Filter Mode] to [No Filter], [Smooth] or [Normal].
16-4
IBP Monitoring
You can adjust the waveform’s coverage (IBP measurement range) on the screen by adjusting the upper scale
and lower scale. The IBP waveform area indicates the waveform scale. The top and bottom of each IBP
waveform represent the upper scale and lower scale of such waveform respectively. You can set the upper
scale and lower scale. As a non-selectable parameter, the middle scale depends on the upper scale and lower
scale.
1) Select [IBPx: XXX] in the waveform area to enter [IBPx: XXX Waveform]. Select an appropriate range
2) You can set the scale range for the pressure names on both channels:
Upper Scale: the pressure value corresponding to the upper scale limit (selectable range: the
Lower Scale: the pressure value corresponding to the lower scale limit (selectable range: the
Middle Scale: the pressure value corresponding to the middle scale limit (selectable range: depend on the
This function allows you to enter [User Maintain] to set the unit of all IBP names except CVP. You can enter
[User Maintain] to set the CVP unit separately.
Select [IBPx: XXX] in the parameter area to enter [IBPx: XXX Setup]. Select [SPV Display] to switch to
[On], then the SPV and PPV measured values are displayed in parameter area.
16-5
Chapter 17 CO2 Monitoring
17.1 Overview
The Monitor uses the CO2 measurement to monitor the patient’s breath state and control his/her ventilation.
There are two methods of measuring the CO2 in the patient’s airway:
Sidestream measurement method: take samples from the respiratory gas sensor in the patient’s airway at
a constant flow rate and use the built-in remote CO2 sensor in the measurement system to analyze them.
Mainstream measurement method: install the CO2 sensor onto the airway connector inserted directly into
End-tidal CO2 (EtCO2): the maximum partial pressure of CO2 at the end of a breath. ②
Fraction of inspiratory CO2 (FiCO2): the minimum CO2 value during inspiration ④
Airway respiration rate (AWRR): the respirations per minute calculated from the CO2 waveform ⑤
Measurement unit ⑥
Note
Do not use the Monitor in an environment with any flammable anesthetic gas.
Only the trained professionals familiar with this Manual are allowed to operate the Monitor.
④ ⑥
③ ② ⑤
Fig 17-1CO2 Waveform and Parameter Display
17-1
CO2 Monitoring
2) Wait for 10s (Masimo sensor) or 2min (Respironics sensor) until the sensor reaches its working
3) Connect the relevant airway adapter to the sensor head and make sure they engage with each other in
place.
5) Expose the sensor to the room air and keep it away from all CO2 sources, like respirator, patient
7) Install the airway adapter onto the proximal end of the respiration circuit, exactly speaking, between the
elbow and the Y-shaped tube of the respirator as shown in the figure below.
Airway Adapter
2) Wait for 10s (Masimo sensor) or 2min (Respironics sensor) until the sensor reaches its working
3) Connect the cannula, airway adapter or sampling tube (as the case may be) to the sensor reliably until
17-2
CO2 Monitoring
To the monitor
To the Monitor
CO2 Sensor
Sensor Adapter
Fig 17-4 Masimo CO2 Connection Diagram for ISA™ Sidestream Analyzer
4) Use the airway adapter for the patient with tracheal cannula: install the airway adapter onto the proximal
end of the respiration circuit, exactly speaking, between the elbow and the Y-shaped tube of the respirator.
17-3
CO2 Monitoring
5) Wear the nasal cannula for the patient without tracheal cannula: wear the nasal or oral-nasal O2 cannula
onto the patient’s face, connect the O2 supply tube to the O2 supply system and set the O2 flow as directed.
Warning
Check the airway adapter before use. Replace it if the airway adapter suffers from any exterior
damage or breakage.
Turn it off when the CO2 sensor is idle, or it will remain in working state and its service life will
be shortened.
Analyzer
The Respironics sidestream analyzer and Respironics mainstream analyzer have almost the same
measurement steps. Please follow the measurement steps for Respironics sidestream analyzer to operate the
Respironics mainstream analyzer.
1) Follow Section 17.2to connect the CO2 sensor based on the CO2 sensor type.
2) Select [Screen Layout] to call up the CO2 waveform and parameter to be monitored (skip this step if the
3) Set [O2 Compensate] in [CO2 Setup] to [21] (in order to activate the value of [O2 Compensate], never
4) Set [Balance Gas] in [CO2 Setup] to [Room Air], [N2O] or [Helium] (select [Room Air] if there is no
5) Set [Altitude] in [CO2 Setup] to 0~5120.6m (default: 0m), depending on the local altitude. When the CO2
value is too high or too low, follow Table 17-1 to select the relevant barometric pressure based on the
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CO2 Monitoring
Table 17-1
Note: it is assumed that the barometric pressure and temperature at the sea level are respectively 760mmHg
and 0℃ (the altitude-based ambient temperature is 0℃).
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CO2 Monitoring
Warning
The Monitor has no auto barometric compensation function. Please set the correct altitude
before using the CO2 measurement function for the first time. Incorrect altitude will cause
incorrect CO2 reading (5% CO2 error per 1,000m altitude difference).
6) Select [Zero] in [CO2 Setup], and the prompt message ―Zeroing, please wait 30s‖ will appear at the lower
right corner of the interface. Do not start the CO2 measurement until such prompt message disappears.
The Masimo sidestream analyzer and Masimo mainstream analyzer have almost the same measurement steps.
Please follow the measurement steps for Masimo sidestream analyzer to operate the Masimo mainstream
analyzer.
Follow the steps below to set the Monitor for gas analysis purpose:
1) Follow Section 17.2 to connect the CO2 sensor based on the CO2 sensor type.
2) Connect the Nomoline sampling tube to the input interface of the ISA analyzer (CO2 sensor).
3) Connect the interface cable of the ISA analyzer to the CO2 interface of the Monitor.
5) Enter the general interface of the Monitor and select [Screen Layout] to call up the CO2 waveform and
parameter to be monitored (skip this step if the CO2 waveform and parameter are already displayed on
the screen).
7) Connect the gas sample outlet to the exhaust system or make the gas flow back to the patient circuit.
8) The green LED indicates that the ISA analyzer is ready for use.
Perform the following operations before connecting the Nomoline sampling tube to the respiration circuit:
1) Connect the sampling tube to the gas inlet of the ISA CO2 sensor.
2) Check if the LED remains green stably (an indication of normal system).
3) Expire into the sampling tube and check if the Monitor displays the effective CO2 waveform and value.
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CO2 Monitoring
5) Check if the prompt message ―Sampling line clogged‖ appears and the LED flashes in red.
6) Check the tightness of the patient circuit connected to the sampling tube when appropriate.
Note
In order to prevent the condensed water dropping into the gas sampling tube and blocking it,
the gas sampling tube connection end of the airway adapter should point up.
Warning
Hang the external CO2 analyzer onto the CO2 sensor holder on the back housing of the Monitor
reliably against falling and damage.
Place the IRMA sensor, if not protected by HME, with the status LED pointing up.
Do not stretch the cable of the ISA sidestream gas analyzer.
Operate the ISA sidestream gas analyzer in the specified working temperature environment
only.
Make sure all connections are firm and reliable. Any leakage will cause the respiratory gas of
the patient to include the ambient air, resulting in incorrect readings.
Follow the steps below to set its work mode after connecting the CO2 sensor to the Monitor. Turn off the CO2
sensor for service life protection purpose once the CO2 measurement is stopped.
1) Select the CO2 parameter area to enter [CO2 Setup] → [Work Mode].
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CO2 Monitoring
Warning
Please set [O2 Compensate] and [N2O Compensate] based on the actual conditions, or the
measurement results may differ greatly from the actual values to cause misdiagnosis.
No-breath detection is to detect the longest interval between two adjacent RESPs. When the actual no-breath
time of the patient exceeds the set no-breath time, the Monitor will respond to no-breath alarms according to
the value of [No Breath Alm Delay].
Set [No Breaths Timeout]:
1) Select the CO2 parameter area to enter [CO2 Setup] → [No Breaths Timeout] and set an appropriate
detection time.
Set [No Breath Alm Delay]:
1) Enter [User Maintain] → [Other Setup].
2) Set [No Breath Alm Delay] to [Off], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or
[1min].
If you select [Off], the alarm delay function will be disabled. The Monitor will respond to no-breath
alarms (if any) immediately.
17.5.5 Altitude
3) Set an altitude value, and the Monitor will auto set [Baro. Pressure] (Barometric Pressure) based on the
altitude value.
17-8
CO2 Monitoring
Only the Respironics CO2 sensor requires you to set the balance gas manually (for Masimo CO2 sensor, the
balance gas is auto set).
1) Select the CO2 parameter area to enter [CO2 Setup] → [Balance Gas].
If you adjust the scale value, the waveform amplitude will change accordingly.
Select the CO2 waveform area to enter [Waveform Setup] → [Scale].
CO2 Sensor
Dip a cloth in 70% isopropyl alcohol, water solution (bleach) containing 10% sodium hypochlorite,
disinfecting spray cleaner (like Steris Coverage SprayHB), ammonia water or mild soapy water, wash it with
water, wring it and then use it to clean the sensor. Dry it and make sure its sight glass is clean before using the
cleaned sensor.
Wash the airway adapter with mild soapy water, dip it in the disinfectant, like 70% isopropyl alcohol, water
solution (bleach) containing 10% sodium hypochlorite, 2.4% glutaraldehyde solvent (Cidex Plus, Steris
System 1, etc.) or ammonia water, and then rinse it with sterile water and dry it.
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CO2 Monitoring
Make sure it is not damaged in operations or in the cleaning/disinfection process and its sight glass is dry
without any residue before using the disinfected airway adapter.
The above disinfection methods allow you to reuse the airway adapter for 100 times.
17.6.5 Zeroing
Usually, the CO2 sensor will be auto zeroed when necessary. You can zero it manually when you consider it
necessary: select [CO2] in the parameter area to enter [CO2 Setup] and then select [Zero] to zero the CO2
sensor. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) for 30s in the zeroing process. The
CO2 sensor is zeroed successfully when the prompt message ―Zeroing, please wait 30s‖ disappears.
17.7.1 Zeroing
In order to eliminate the effect of the baseline drift on measurement results and obtain accurate measurement
results, please zero it before using the CO2 sensor to monitor the patient.
Usually, the CO2 sensor will be auto zeroed when necessary. You can zero it manually when you consider it
necessary: select [CO2] in the parameter area to enter [CO2 Setup] and then select [Zero] to zero the CO2
sensor. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) in the zeroing process. The CO2
sensor is zeroed successfully when the prompt message ―CO2 is zeroing‖ disappears.
The ISA CO2 Module needs to establish a zero reference level for the CO2 measurement. This zero
calibration is here referred to as ―Zeroing‖.
The ISA sidestream gas Module performs zeroing automatically by switching the gas sampling from the
respiratory circuit to the ambient air. The automatic zeroing is performed every 24 hours and takes less than 3
seconds for ISA CO2 gas module. During zeroing, if ISA’s exhaust gas is return to the patient circuit, the
return gas level will be different from the gas level at the sampling site.
Warning
Since successful zeroing requires the presence of ambient air in the gas module, ensure that
the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas
module before or during the zeroing procedure.
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CO2 Monitoring
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 medical backboard device 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 in the IRMA airway adapter is of crucial importance for a successful
Zeroing. If a ―CO2 Need Zero‖ alarm should appear directly after a Zeroing procedure, the procedure has to be
repeated.
Always perform a pre-use check after Zeroing the probe.
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 probes after power on before proceeding with the Zeroing
Procedure.
Allow the IRMA probe to warm up for at least 10 seconds after changing the IRMA airway adapter before
transmitting the Zero reference command.
Warning
Incorrect probe Zeroing will result in false gas readings.
17.7.1.3 Maintenance
Verify the gas readings regularly. Contact the engineers from the manufacturer for maintenance in case of any
inaccurate reading.
LED indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check adapter
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CO2 Monitoring
1) The following factors have the known adverse effects on the specified performance:
Quantitative effects of RH or condensation;
Quantitative effects of barometric pressure;
Interfering gas or water vapor; and
Other interference sources.
2) Gas Measurement Unit
Use volume percentage as the gas concentration unit. Below is the concentration calculation formula:
Use the cup-making pressure sensor of the ISA gas analyzer to measure the total pressure of the gas mixture.
To convert into any other unit, you can use the actual barometric pressure sent from the ISA sidestream
(IRMA mainstream).
CO2 (mmHg) = (CO2 Concentration) x (Barometric Pressure from ISA (kPa)) x (750 / 100).
Take 5.0 vol% CO2 @ 101.3kPa as an example: 0.05 x 101.3 x 750 / 100 = 38 (mmHg).
3) Effects of RH
The partial pressure and volume percentage of the CO2, N2O, O2 and anesthetic gas depend on the water
vapor content in the measured gas. Calibrate the O2 measurement, and the displayed value at the ambient
temperature and RH level will be 20.8 vol%, not the actual partial pressure. The 20.8 vol% O2 represents the
actual O2 concentration of the room air (water concentration: 0.7 vol%) (for example, 25°C and 23% RH @
1013hPa). The Monitor will keep displaying the actual partial pressure at the current RH level when
measuring the CO2, N2O and anesthetic gas (like all gases measured by infrared cell).
In the patient’s alveoli, the water vapor in the respiratory gas is saturated (BTPS) at the body temperature.
Before the acquired respiratory gas in the sampling tube is transferred to the ISA sidestream gas analyzer, its
temperature becomes approximate to the ambient temperature. No water will enter the ISA gas analyzer after
the Nomoline sampling tube removes all condensed water. The RH of the acquired gas is approximately 95%.
Use the following formula to calculate the CO2 value at BTPS:
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CO2 Monitoring
Warning
The ISA sidestream gas analyzer is intended for use by authorized healthcare professionals
only.
Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.
Do not lift the ISA gas analyzer by the sampling line as it could disconnect from the ISA,
causing the ISA gas analyzer to fall on the patient.
Dispose Nomoline Family sampling lines in accordance with local regulations for biohazardous
waste.
Use only airway T-adapters with the sampling point in the center of the adapter.
Do only use sample lines intended for anesthetic agents if N2O and/or anesthetic agents are
being used.
Do not use T-adapter with infants, as this adds 7 ml dead space to the patient circuit.
Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as this
may clog the bacteria filter.
Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure
that the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas
analyzer before or during the zeroing procedure.
Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
The ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It must
be used in conjunction with other assessments of clinical signs and symptoms.
Measurements can be affected by mobile and portable RF communications equipment. Make
sure that the ISA sidestream gas analyzer is used in the electromagnetic environment specified
in this manual.
Replace the sampling line if the sampling line input connector starts flashing red, or the
medical backboard device displays a “Check sampling line” message.
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.
The ISA sidestream gas analyzers are not designed for MRI environments.
During MRI scanning, ISA must be placed outside the MRI suite.
Use of high frequency electrosurgical equipment in the vicinity of the ISA/medical backboard
device may produce interference and cause incorrect measurements.
Caution
The ISA analyzers should be securely mounted in order to avoid the risk of damage to the
ISA.
Do not operate the ISA sidestream gas analyzer outside the specified operating environment.
(US Only) Caution: Federal law restricts this device to sale by or on the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
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CO2 Monitoring
Warning
The IRMA analyzers should be securely mounted in order to avoid the risk of damage to the
IRMA.
Do not operate the IRMA sidestream gas analyzer outside the specified operating environment.
(US Only) Caution: Federal law restricts this device to sale by or on the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
The IRMA probe is intended for use by qualified medical personnel only.
The IRMA probe is intended only as an adjunct in patient assessment. It must be used in
conjunction with other assessments of clinical signs and symptoms.
Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter can
cause cross infection.
Used airway adapters shall be disposed of in accordance with local regulations for
biohazardous waste.
Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml
dead space to the patient circuit.
Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow
resistance.
Measurements can be affected by mobile and RF communications equipment. It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.
Use of high frequency electrosurgical equipment in the vicinity of IRMA may produce
interference and cause incorrect measurements.
The IRMA probe is not designed for MRI-environments.
Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect operation.
To keep secretions and moisture from pooling on the windows, always position the IRMA probe
in a vertical position with the LED pointing upwards.
Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as
this may affect the light transmission of the airway adapter windows.
Incorrect probe zeroing will result in false gas readings.
Replace the airway adapter if rainout/condensation occurs inside the airway adapter.
Use only Masimo manufactured IRMA airway adapters.
The IRMA probe is not intended to be in patient contact.
If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant's
body an insulation material shall be placed between the IRMA probe and the body.
No modification of this equipment is allowed.
Caution
Never sterilize or immerse the IRMA probe in liquid.
The IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will
damage them.
Do not apply tension to the probe cable.
Do not operate the IRMA probe outside the specified operating temperature environment.
17-14
CO2 Monitoring
(U.S. only) Caution: Federal law restricts this device to sale by or on the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
When the anesthetic gas airway is obstructed, on the screen there will be such a prompt message as ―Sampling
Line Clogged‖; under such a circumstance, replace the Nomoline sampling line.
Warning
Do not use the ISA gas analyzer together with a quantitative spraying agent or pulverization
treatment; otherwise it may result in the clogging of the germ filter.
When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from polluting the
operating room. Usually the gas discharging outlet should be connected to (via the gas discharging pipe
connected to the sample gas outlet of the host equipment):
A discharging system (used for discharging collected gases) or the patient circuit (used for the back flowing of
collected gases)
Warning
Anesthetics: When an anesthetic which is being used or a patient who recently used an
anesthetic is measured, the gas discharging hole on the module must be connected to a waste
gas processing system or the patient circuit (on the anesthesia machine or the respirator), so as
to prevent medical personnel from inhaling the anesthetic.
1. Connect a new Nomoline sampling line with male Luer lock to the ISA gas inlet connector and check
that the gas inlet connector shows a steady green light.
2. Connect a short silicon tubing with an inner diameter of 3/32‖ (2.4 mm) to the Nomoline male Luer.
3. Exhale a long breath into the silicon tubing until the CO2 concentration is greater than 4.5 vol% or 34
mmHg.
4. Quickly connect the silicon tubing tightly to the exhaust port.
5. Wait 1 minute until the CO2 concentration has stabilized. Note the value.
6. Wait 1 minute and check that the CO2 concentration has not decreased more than 0.4 vol% or 3 mmHg.
If it has decreased more there is a major leakage in the ISA unit or in the Nomoline. Do not operate the
ISA if there is a major leakage in the unit.
17-15
CO2 Monitoring
Reference No.
Serial No.
Lot No.
Valid until [YYYY-MM-
Do not use the Monitor after such date.
DD]
Temperature limit
Pressure limit
RH limit
No reuse
Recycle this electrical and electronic equipment
WEEE directive
according to 2002/96/EC.
Contain Pb
Gas inlet
17-16
CO2 Monitoring
Not sterile, latex free The Monitor is latex free and not sterile.
17.7.9 Consumables
ISA samples gas from the respiratory circuit through the Nomoline Family sampling line at a rate of 50
sml/min, making measurements of CO2 possible for adult, pediatric and infant patients.
The Nomoline Family sampling lines incorporate a unique water separation (NO MOisture) section, which
removes condensed water. The NOMO section is also fitted with a bacteria filter that protects the gas analyzer
from water intrusion and cross contamination.
As long as no sampling line is connected, the ISA gas analyzer remains in a low-power sleep mode. Once the
sampling line is connected, the ISA gas analyzer switches to measuring mode and starts delivering gas data.
The Nomoline Family sampling lines are available in a wide variety of versions for both intubated and
spontaneously breathing patients and in both disposable and re-sposable configurations –intubated patients
can for instance be monitored using the disposable Nomoline Airway adapter Set or a com-bination of the
multiple patient use Nomoline Adapter and a disposable Nomoline Extension / T-adapter. Spontaneously
breathing patients could similarly be monitored using a disposable Nomoline Nasal CO2 Cannula or a
combination of the multiple patient use Nomoline Adapter and a disposable Nomoline Nasal CO2 Cannula
with Luer Connector.
17-17
CO2 Monitoring
OR
Figure 1.The disposable Nomoline Airway Adapter Set is an alternative to using a combination of the multiple
patient use Nomoline Adapter and a disposable Nomoline Extension / T-adapter.
The Nomoline Adapter may be used with other third party sampling lines and cannulas. Please however note
that the Nomoline Family of sampling lines are designed for optimal performance and measure-ment fidelity
when used with the ISA gas analyzers. For instance, when connecting to a respiratory circuit, the Masimo T-
adapter provides a central gas sampling point thereby minimizing the the risk of sampling line occlusion (see
below)
Figure 2. For optimal water handling, always use T-adapters with the sampling point in the center of the
adapter, as shown to the left above.
Attention
Using sample tubes or cannulas with larger inner diameter than 1 mm will increase ISA’s total
system response time.
The IRMA airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit.
The respiratory gas measurements are obtained through the XTP™ windows in the sides of the adapter. The
XTP windows are transparent to light in the wavelength ranges of interest and they are specially designed
17-18
CO2 Monitoring
using the latest advances in material technology to provide a window minimizing the impact of water vapor
on light transmission.
Warning
Replace the airway adapter if rainout/condensation occurs inside the airway adapter.
The IRMA airway adapter is designed as a non-sterile single patient use disposable for both Adult/Pediatric
and Infant applications. The IRMA Infant airway adapter has specially designed connectors for minimizing
the dead space and can be used even for very small patients.
IRMA airway adapters: Adult/Pediatric (REF: 106220) and Infant (REF: 106260)
Warning
Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml
dead space to the patient circuit.
Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow
resistance.
17.7.10 Maintenance
The user should verify gas readings regularly; If finding any problems, please contact an engineer of the
manufacturer for maintenance.
The ―Plug in and measure‖ ISA sidestream gas analyzer should be cleaned regularly. Use ethanol or isopropyl
alcohol with a maximum concentration of 70% and a wet rag to clean the analyzer..
In order to prevent the cleaning liquid and dust from entering into the ISA gas analyzer from the LEGI
interface, the Nomoline sampling line should be connected all the time during analyzer cleaning.
Before cleaning the IRMA probe, take off the disposable IRMA airway adapter.
Warning
The Nomoline sampling line is not a germ free device. In order to prevent the sampling line
from causing damages, please never carry out high pressure disinfection on any part of the
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CO2 Monitoring
sampling line.
Never sterilize the ISA sidestream gas analyzer and the IRMA probe or soak them into a
liquid.
17-20
Chapter 18 AG Monitoring
18.1 Overview
The AG (anesthetic gas) module is used to measure the anesthetic gases and respiratory gases of the patient
under anesthesia. It provides the Et value and Fi value of the following gases:
CO2: EtCO2 (the maximum exhaled CO2 value detected in the respiration).
O2: oxygen.
MAC: minimum alveolar concentration (the basic index reflecting the depth of inhalation anesthesia).
Respiratory gases can be analyzed with multiple measurement principles. The absorption characteristics of the
gas sample are usually isolated with the dispersive infrared (DIR) absorption spectrometry or non-dispersive
infrared (NDIR) absorption spectrometry. The DIR spectrometry uses a single optical filter and a prism or
diffraction grating to separate the wavelength of each anesthetic, while the NDIR spectrometry uses multiple
narrow-band filters to filter the infrared rays so as to identify the gases in the gas mixture.
The most commonly used gas analysis method is the medium based on the NDIR spectrometry. Its
measurement principle is based on the fact that multiple gases absorb the infrared energy of a specific
wavelength.
The sidestream sampling based infrared multi-gas analyzer usually acquires the gas sample continuously at
the joint of the respiration circuit and airway device (respirator, tracheal catheter or laryngeal mask airway).
The gas sampling rate of such modern gas analyzer is 50ml/min~250ml/min. The gas sample goes through the
infrared transmitter, optical filter and infrared detector by means of a small cup or sample chamber. The
output signal of the infrared detector is proportional to the infrared energy unabsorbed by gases. To quantify
and identify multiple gases (N2O, CO2 and the five inhalational anesthetic gases) simultaneously, multiple
18-1
AG Monitoring
optical filters are required. The detected signal is amplified and converted by the microprocessor with the
complex algorithm. Please note that the infrared spectrometry is not applicable to O2 measurement. The gas
analyzer uses an accessory to measure the O2, like paramagnetic O2 sensor.
18.3 AG Display
The following waveform and parameter values measured by the AG module will be displayed on the screen of
the Monitor:
CO2 (AG), O2, N2O and AA waveform;
The Et value and Fi value of CO2 (AG), O2, N2O and AA.
―AA‖ stands for Des, Iso, Enf, Sev or Hal.
When two or more anesthetic gases are detected by the AG analyzer, only the primary anesthetic gas will be
displayed in the waveform area. The secondary anesthetic gas will not be displayed. However, the message
―Found two AG gas‖ will appear in the message display area.
Warning
To prevent explosion, never use diethyl ether, cyclopropane or any other flammable anesthetic.
Note
The waveform and parameter values of one anesthetic gas will be displayed at a time. When
there is a second anesthetic gas, the message “Found two AG gas” will appear in the message
display area.
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AG Monitoring
MAC is used to measure the effect of anesthetic gas inhalation. The MAC value represents the concentration
(one barometric pressure) of the anesthetic gas in the alveoli, namely, the concentration causing 50% of the
measured patients to have no muscular movement response to standard pain stimulation.
If the Monitor is enabled to measure the MAC, the calculation of the MAC value must be recorded in detail.
The following formula can be used to calculate (and display) the MAC value from the end-tidal (Et) gas
concentration:
For example, if one or more anesthetic gases are used and the Et concentration of Des, Hal and N2O measured
by the AG module are respectively 4%, 0.5% and 50%, the MAC value will be:
Note
In the above formula, the altitude, patient’s age and other personal factors are not taken into
consideration.
18.5 O2 Sensor
Paramagnetic O2 Analysis
The principle of paramagnetic O2 analysis is to measure the attraction of the high-intensity magnetic field to
the O2 molecules in the gas mixture. The paramagnetic analyzer differentiates the O2 from other gases based
on their magnetization sensitivity. The O2 will be attracted by the magnetic field because it is paramagnetic.
Most of other gases are not paramagnetic. If we specify a magnetization sensitivity value of 100 for the O2,
the magnetization sensitivity value of most of other gases will be almost 0.
The Servomex paramagnetic O2 sensor PM1116 is compatible with the ISA gas analyzer. Such sensor will
generate a symmetrical non-uniform magnetic field. If there is any O2, the O2 will be attracted to the most
magnetic part of such magnetic field. In such magnetic field, the rotary rack is equipped with two glass balls
filled with nitrogen and one mirror (in the middle). The beams of light projected to the mirror will be reflected
to a pair of phototubes. The O2 attracted to the most magnetic part of the magnetic field will drive the glass
balls and rotate the rack. The phototubes will generate the relevant signal and transfer it to a feedback system
if any rotation is detected. The feedback system will supply current to the cable of the rack, generating a
18-3
AG Monitoring
reaction torque to keep the rack in its place. Such current is proportional to the O2 concentration. To obtain
the O2 concentration value, just measure such current.
The paramagnetic O2 sensor has the following main advantages:
Short rise time;
Follow the steps below to set the Monitor for gas analysis purpose:
1) Connect the Nomoline sampling tube to the input interface of the ISA analyzer (AG module).
4) Enter the general interface of the Monitor and select [Screen Layout] to call up the AG waveform and
parameters to be monitored (skip this step if the AG waveform and parameters are already displayed on
the screen).
5) Connect the gas sample outlet to the exhaust system or make the gas flow back to the patient circuit.
6) The green LED indicates that the ISA analyzer is ready for use.
Sampling Tube
18-4
AG Monitoring
Perform the following operations before connecting the Nomoline sampling tube to the respiration circuit:
1) Connect the sampling tube to the gas inlet (LEGI) of the ISA AG module.
2) Check if the LEGI LED remains green stably (an indication of normal system).
3) If the ISA AG module is equipped with an O2 accessory, check if the reading on the Monitor is correct
(21%).
4) Expire into the sampling tube and check if the Monitor (or small host) displays the effective CO2
6) Check if the alarm message ―Sampling line clogged‖ appears and the LEGI LED flashes in red.
7) Check the tightness of the patient circuit connected to the sampling tube when appropriate.
Note
If the message “O2 sensor disconnect” appears on the screen, reinstall the O2 sensor.
To prevent the condensed water dropping into the gas sampling tube and blocking it, the gas
sampling tube connection end of the airway adapter should point up.
Warning
Hang the external AG analyzer onto the AG module holder on the back housing of the Monitor
reliably against falling and damage.
Place the IRMA sensor, if not protected by HME, with the status LED pointing up.
Do not stretch the cable of the ISA sidestream gas analyzer.
Operate the ISA sidestream gas analyzer in the specified working temperature environment
only.
Make sure all connections are firm and reliable. Any leakage will cause the respiratory gas of
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AG Monitoring
18.7 AG Setup
Select [AA], [O2], [N2O] or [CO2 (AG)] in the parameter area to enter [AA Setup], [O2 Setup], [N2O Setup] or
[CO2 Setup].
1) Click the AA, O2, N2O or CO2 (AG) parameter area to enter [AA Setup], [O2 Setup], [N2O Setup] or
[Standby]: in order to protect the AG module’s service life, the pneumatic pump will stop working with
the message ―AG is sleeping‖ appearing in the message area when the AG module is in standby state.
[Measure]: in measurement state, the AG module, with its LED remaining green, will send the measured
The O2 sensor will automatically compensate based on the actual concentration of O2 in patient circuit, so [O2
Compensate] is a default option. If no O2 sensor is available to provide the O2 compensation, set the O2
compensation level manually based on the actual concentration of O2 in patient circuit.
1) Click the CO2 (AG) parameter area to enter [CO2 Setup] → [O2 Compensate] → [High], [Med]
(medium) or [Low].
[N2O Compensate]: if you select [On], the AG module will auto compensate the N2O.
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AG Monitoring
Warning
Please set [O2 Compensate] and [N2O Compensate] based on the actual conditions, or the
measurement results may differ greatly from the actual values to cause misdiagnosis.
For N2O, O2 and anesthetic gas AA, the unit defaults to %. For the unit of CO2(AG), enter [User Maintain]
and set the press unit to [mmHg] or [kPa].
No-breath detection is to detect the longest interval between two adjacent breaths. When the actual no-breath
time of the patient exceeds the set no-breath time, the Monitor will respond to no-breath alarms according to
the value of [No Breath Alm Delay] (no breath alarm delay).
Set [No Breaths Timeout]:
1) Click the CO2 (AG) parameter area to enter [CO2 Setup] → [No Breaths Timeout] and set an
2) Set [No Breath Alm Delay] to [Off], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or
[1min].
If you adjust the scale value, the waveform amplitude will change accordingly.
Select the AA, O2, N2O or CO2 (AG) waveform area to enter [Waveform Setup] → [Scale].
18.7.4 Zeroing
To zero the infrared gas analyzer, please determine the zero baseline of CO2, N2O and anesthetic gas
measurement.
Auto Zero
The ISA sidestream gas analyzer performs auto zeroing by switching the gas sampling from respiration circuit
to ambient air. Auto zeroing (ISA CO2 analyzer: ≤3s; ISA multi-gas analyzer: ≤10s) is performed every 24
18-7
AG Monitoring
hours. If the ISA sidestream gas analyzer is equipped with an O2 sensor, auto zeroing also includes the room
air calibration for O2 sensor.
Manual Zero
Click [AA] in the parameter area to enter [AA Setup] → [Zero]. Keep the patient circuit in the ambient air (21%
O2 and 0% CO2) for 30s in the zeroing process. The zeroing operation can be performed when [Zero] is in
settable state rather than default state.
Warning
Successful zeroing requires the ambient air (21% O2 and 0% CO2), so the ISA gas analyzer
should be installed in a well-ventilated place. No respiration is allowed around the ISA gas
analyzer before and after the zeroing operation is performed.
LED indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check adapter
Steady blue light Anesthetic agent present
18-8
AG Monitoring
18.16 Consumables
18.17 Maintenance
18-9
Chapter 19 C.O. Monitoring
19.1 Overview
C.O. (cardiac output) measurement is to use the regular thermodilution method to measure the C.O. and other
hemodynamic parameters in an invasive way. The Monitor can measure the C.O. and blood temperature and
perform the hemodynamic calculation.
Place the float catheter into the pulmonary artery by way of the vein and inject a certain dose of low-
temperature injection via the float catheter. When the injection is mixed with the blood output from the heart,
the blood temperature will change. The C.O. value can be obtained from the blood temperature change (after
the injection is injected) curve based on the heat balance principle.
In C.O. measurement, you can use the perfusion system or a separate syringe to inject the room-temperature
injection or ice water. The Monitor can save the results of up to 6 measurements. If more than 6
measurements are performed before editing the measurement results, the result of the earliest measurement
will be deleted.
1) Click the C.O. parameter area to enter [C.O. Setup] → [Measure Mode].
[Manual]: when the message [Ready for new measurement] appears in the message area, select [Start] to
start the fast liquid injection. The ―C.O. Measure‖ window will display the realtime thermodilution
curve. After each measurement, the measured values will be displayed in the measurement history
window. Wait a certain time subject to the value of [Meas Interval(s)] (measurement interval) before
[Auto]: the C.O. measurement will be auto performed based on the value of [Meas Interval(s)] (you do
not need to select [Start] manually). When the message ―Injest New‖ appears in the ―C.O. Measure‖
window, you can start the measurement by injecting the ice water.
19-1
C.O. Monitoring
1) Click the C.O. parameter area to enter [C.O. Setup] → [C.O. Coefficient] and then enter an appropriate
coefficient.
[C.O. Coefficient]: 0~0.999 (the calculation coefficient related to float catheter and injection
volume). Adjust this coefficient as instructed by the float catheter manufacturer after replacing the
float catheter.
1) Click the C.O. parameter area to enter [C.O. Setup] → [IT Source] (injection temperature source) →
[Auto] or [Manual].
1) Click the C.O. parameter area to enter [C.O. Setup] → [Inj Temp] (injection temperature) and then enter
an appropriate temperature.
2) [Inj Temp]: 0~27.0. Set [Inj Temp] manually if [IT Source] is set to [Manual].
Enter [User Maintain] to set the value of [Temp Unit] (temperature unit).
To ensure accurate measurements, please set a measurement interval so that the normal blood temperature can
be resumed before the next measurement is started.
1) Click the C.O. parameter area to enter [C.O. Setup] → [Meas Interval(s)].
19-2
C.O. Monitoring
1) Click the C.O. parameter area to enter [C.O. Setup] → [Inject Vol] (injection volume).
Warning
Do not touch any conductive metal when using any accessory.
Select an injection volume and calculation coefficient compatible with the float catheter. Enter
the calculation coefficient as instructed in the User’s Manual of the float catheter after
replacing the float catheter.
Caution
Use the cable, catheter and sensor accessories recommended by us only.
Note
No settings can be changed in the C.O. measurement process.
3) Enter the general interface of the Monitor and select [Screen Layout] to call up the C.O. waveform and
parameters to be monitored (skip this step if the C.O. parameters is already displayed on the screen).
4) Connect the C.O. cable, float catheter, syringe and other accessories as shown below:
19-3
C.O. Monitoring
The Monitor
Cable Injection
Syringe
Three-way Cock
Temperature Sensor
Float Catheter
Ice Water
Airbag’s Inflation Inlet
5) Enter the general interface of the Monitor and select [Screen Layout] to call up the C.O. parameters to be
monitored (skip this step if the C.O. parameters are already displayed on the screen).
6) Enter [Main Menu] → [Patient Manage] or directly select the patient information area in the upper menu
bar to enter [Patient Info] (patient information) and then set the patient’s height and weight.
7) Click the C.O. parameter area to enter [C.O. Setup] and then follow Section 19.3 C.O. Setup to adjust the
C.O. settings.
[C.O. Coefficient]: set the calculation coefficient related to float catheter and injection volume.
Adjust this coefficient as instructed by the float catheter manufacturer after replacing the float
catheter.
[IT Source]: if you select [Auto], the Monitor will measure the realtime injection temperature
8) Click the C.O. parameter area to enter [C.O. Setup] → [C.O. Measure], you will open the following
19-4
C.O. Monitoring
Current measured
values and C.O. curve
Message area
Functional keys
In the ―C.O. Measure‖ window, you can perform the C.O. measurement. The ―C.O. Measure‖ window
displays the following information:
Measurement messages;
Measurement curve;
Measurement time;
Functional keys.
9) When the message ―Ready For New Measurement‖ appears in the message area, select [Start] and inject
the injection immediately (in 4s). The ―C.O. Measure‖ window will display the realtime thermodilution
curve. After each measurement, the measured values will be displayed in the measurement history
Note
To start the measurement, turn on the float catheter end and turn off the injection end of the
three-way cock respectively. After the measurement, turn off the float catheter end and turn
19-5
C.O. Monitoring
on the injection end of the three-way cock respectively, and then draw the injection back to
the syringe.
When the injection temperature goes beyond the limit (30), the message “High injection
temperature” will appear. Please replace the injection and try the measurement again.
Inject the injection within 4s after selecting [Start] in the “C.O. Measure” window.
In the ―C.O. Measure‖ window, you can perform the following operations:
[Start]: start a C.O. measurement.
[Stop]: click this key to stop it if the measurement remains in process for long.
[Calculate]: enter the [Hemodynamic], enter the relevant values in the [Input] part and click [Calculate]
to obtain the calculation results in the table below. Refer to Section Hemodynamic Calculation.
Note
To obtain the hemodynamic calculation results, please remember to enter the parameter
values in the [Input] part.
To perform the [Review] operation, save the calculation results first.
When no C.O. measurement is performed, use the thermistor at the end of the float catheter in the pulmonary
artery to measure the blood temperature.
19-6
C.O. Monitoring
Connect the C.O. measurement catheter sensor to the interface to obtain the blood temperature reading.
Anxious patient;
Catheter damage;
Keep the injection temperature lower than the patient’s blood temperature;
Wait 1min until the stable baseline of blood temperature is resumed before starting the next
measurement.
19-7
Chapter 20 ICG Monitoring
20.1 Overview
The ICG (impedance cardiography) measurement is based on the impedance cardiography (thoracic
bioelectrical impedance technique: an indirect TEB measurement method, calculate the stroke ejection output
based on the changes of the thoracic blood flow impedance caused by cardiac ejection and then calculate the
cardiac output and other hemodynamic parameters.
The ICG module injects high-frequency AC signals into the patient’s thoracic cavity and generates the
impedance cardiography based on the impedance changes caused by periodic blood flow changes.
Warning
The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg
(67~341 pounds) in weight only.
Do not perform the ICG monitoring to any patient implanted with a minute ventilation (MV)
pacemaker with the MV sensor function enabled.
In the ICG monitoring process, do not allow the conductive gel of the sensor to touch any
conductive object.
Use the ICG sensor for a single patient only.
Select the ICG parameter area to enter [ICG Setup] → [Hemodynamic] to view the following hemodynamic
data on the patient’s current condition:
C.O. Cardiac output (_I, _Z)
C.I. Cardiac index (_I, _Z)
SI Stroke index (_I, _Z)
SV Stroke volume (_I, _Z)
SVR Systemic vascular resistance (_I, _Z)
SVRI Systemic vascular resistance index (_I, _Z)
20-1
ICG Monitoring
HR Heart rate
TFC Thoracic fluid composition
QI Quality indicator
DO2I Oxygen delivery index
The above HR value is not obtained by the ECG module but by the ICG module.
One thoracic impedance waveform and the ICG parameter area are displayed on the screen. The values of the
primary parameter CI and two secondary parameters are displayed in the ICG parameter area as shown below:
Aortic regurgitation;
3) Enter the general interface of the Monitor and select [Screen Layout] to call up the ICG waveform and
parameters to be monitored (skip this step if the ICG waveform and parameters are already displayed on
the screen).
20-2
ICG Monitoring
6) Make full skin preparations to the patient and install the sensor onto the patient.
7) Follow their numbers to connect the connecting leads to the sensor on the patient.
The quality of the ICG information provided by the Monitor depends on the quality of the electrical signals
received by the sensor. To acquire high-quality signals, it is necessary to make full skin preparations to the
patient.
Select a skin area to place the sensor and then follow the steps below:
1) Remove the body hair from the selected area;
2) Wipe the dead skin cells lightly off the skin surface in the selected area;
3) Clean the skin in the selected area thoroughly to remove all oily residues, dead cells and abrasive (the
To acquire good-quality signals and accurate values, it is important to install the sensor to the appropriate
location as shown below:
1) Place the neck sensor vertically under the earlobes at both sides of the neck;
2) Place the upper chest sensor at the intersection of the xiphoid process level and the mid-axillary line at
3) The above two sensors must be placed directly opposite to each other (180°).
20-3
ICG Monitoring
Select the ICG parameter area to enter [ICG Setup] and set the following parameters:
[Secondary Param.] (secondary parameter): SV, SVRI, SI, C.O., SVR, QI or DO2I.
[Patient Info]: input such information of the current patient as sex, age, height, weight, BSA (body
surface area), Sys (systolic pressure), Dia (diastolic pressure), MAP (mean arterial pressure), CVP
(central venous pressure), PAOP (pulmonary artery occlusion pressure), HB (hemoglobin) and SpO2.
20.8 Maintenance
Warning
The cross infection of blood products may cause virus infection. Disinfect any equipment
likely to contact blood products with extra caution.
Clean the outer surface of the patient cable and electrode wire:
Use a soft non-abrasive cloth dipped in any approved detergent to clean the outer surface.
Use any detergent made from isopropyl alcohol, acetone, iodine, phenol, chlorine or ammonia
water;
Dip them in any detergent or apply any detergent directly on their surface;
20-4
Chapter 21 BIS Monitoring
21.1 Overview
BIS (bispectral index) monitoring includes using the EEG signals of the electrical activities in the cerebral
cortex and the frequency spectrum and power spectrum analysis method to give the quantitative bispectral
index, and assessing the patient’s current state of consciousness comprehensively based on the EEG signal
quality analysis and other factors so as to identify the bispectral index.
The Monitor can measure such parameters as BIS, EMG, SR and SQI and display one BIS EEG waveform
generated in the continuous detection of EEG signals by the BIS module and one BIS trend.
The BIS waveform area has two display modes: BIS EEG waveform and BIS trend.
21-1
BIS Monitoring
Considering the limited clinical experience, please explain the BIS value prudently to any patient with
neurological abnormalities, taking antipsychotics or aged less than 12 months.
Warning
Never consider BIS as the sole parameter for anesthetic dose adjustment.
Do not allow the sensor and its conductive parts to contact any other conductive part or the
ground.
To reduce the risk of burns, do not place the BIS module between the surgical site and the return
electrode of the electrosurgical unit in high-frequency surgeries.
Do not place the BIS sensor between the defibrillator electrode pads when any defibrillator is
connected to the patient.
21-2
BIS Monitoring
1) The BIS module receives signals through the cable. First, connect the BIS module directly to the
Monitor.
3) Enter the general interface of the Monitor and select [Screen Layout] to call up the BIS waveform and
parameters to be monitored (skip this step if the BIS waveform and parameters are already displayed on
the screen).
4) Fix the BIS module beside the patient (lower than the patient’s head) through the clamp on its back.
6) Follow the User’s Manual of the BIS sensor to attach the BIS sensor to the designated position on the
patient’s head.
7) Connect the BIS sensor to the patient cable. The Monitor will auto measure the impedance of all
electrodes and display the measured values in the ―Electrode Impedances‖ window once an effective
sensor is detected.
See the figure below:
The
Monitor
BIS Module
Patient Cable
BIS Sensor
21-3
BIS Monitoring
Warning
To ensure accurate BIS monitoring, it is important to place the electrodes in the correct
positions.
The electrodes can be placed in the left or right of the scalp.
To protect the patient’s safety, do not fix the BIS module higher than the patient’s head.
Make sure the patient’s skin is dry. A damp sensor or salt bridge may cause inaccurate BIS
value and impedance value.
Select [BIS] in the parameter area to enter [BIS Setup] → [Electrode Impedances] (test the electrode
impedances manually), and the following window will be opened:
The measurement state and impedance values are displayed in the ―Electrode Impedances‖ window:
Icon State or Cause Required Measures
21-4
BIS Monitoring
21.6.1 Scale
1) Select the BIS waveform area to enter [Waveform Setup] → [BIS Display].
Set the BIS trend time to view the BIS trend data in the past relevant time.
1) Select the BIS waveform area to enter [Waveform Setup] → [Trend Time].
Set the interval for BIS value equalization operations. Lower smoothing rate will result in more sensitive
response of the Monitor to signal changes. Higher smoothing rate will result in smoother BIS trend, less
vulnerable to interference.
1) Select the BIS waveform area to enter [Waveform Setup] → [Smoothing Rate].
1) Replace the sensor when the technical alarm message ―Change sensor‖ appears in the measurement
process.
2) Select the BIS parameter area to enter [BIS Setup] → [Confirm Sensor Change], and you will receive the
21-5
BIS Monitoring
21.6.6 Filter
Click the BIS parameter area to enter [BIS Setup] → [Module Info] (module information) to view the OC/BIS
plate’s serial number, firmware version, module’s serial number, etc.
21-6
Chapter 22 Data Review
Select the [Review] quick key, or select [Main Menu]; then select [Review] to enter the Review interface.
Data Review includes: NIBP Measurement Review, Alarm Event Review, Trend Graph Review, Trend Table
Review, Wave Review.
The monitor provides 160h trend data, 2,000 sets of NIBP measurement data, 200 times of storage of
parameter alarm events, and at most 48h wave review of single-channel wave (the specific time is related to
the waves saved and the number of waves). This chapter introduces the method for observation of these saved
data in detail.
User can select the wave to be saved according to requirement. Only waves set to be saved can be viewed in
[Wave Review]. After admitting a patient, it will be impossible to modify Wave Save selection.
1) Enter [User Maintain] → [Wave Save].
2) Select the parameter whose wave is to be saved, and select [Enter]; make a selection according to the
prompt message.
[Rec. Merge]: Admit a new patient and create a patient file, and save current monitoring data to the
patient file created.
[Rec. Not Merge]: Admit a new patient and create a patient file, but current monitoring data are not
saved to the patient file created.
Trend is a set of patient data over time manifested in the form of graph or table.
In the [Trend Review] window, select [Trend Graph] or [Trend Table] to review the corresponding data.
The trend graph shows recent data that are updated continuously; the bottom of the screen shows the time
scale.
User can select the desired wave via the parameter area on the left side of the window; besides, user can
browse the trend database via a cursor crossing all measurement items in the window. When moving the
cursor, the current parameter trend data and specific time of data are shown on the right side of the
corresponding window:
22-1
Data Review
Cursor
Aperiodic measurements can be viewed from the trend table. This table shows measurement data and
measurement time. Trend table data during a period of maximally 160h can be viewed.
Symbol Description
Symbol Introduction
Turn page up and down to view other parameter trend graphs not shown in the current
view.
22-2
Data Review
Move the cursor left or right by one step to view along the timeline of trend database.
Move the cursor left or right by one page to view along the timeline of trend database.
Jump to the start point or end point of the trend database to view the farthest (earliest)
or nearest (latest) trend info saved.
Select the date field beside [Start Time]; the Setup window will pop up, where user can set the start time
Trend Interval refers to the resolution of trend data shown on the screen. For neonate monitoring, since
the clinical condition of the patient changes fast, a high resolution can be selected; for adult monitoring,
since the clinical condition of the patient changes relatively slowly, a low resolution can be selected.
Set [Res.] (Resolution)
1) In the Trend Graph Review window
Select [1s] or [5s] to view the short trend during the past 1h.
Select [10s] to view the medium trend during the past 4h.
Select [1 Min], [5 Min] or [10 Min] to view the long trend during the past 160h.
Select [1 Min], [5 Min], [10 Min], [30 Min], [60 Min], [120 Min] or [180 Min] to view the trend
In the [Trend Table] menu, select to enter the [Trend Table Review Report] menu. User can set the
Record Time: Determine which period of trend data will be output via [Start Time] and [Forward
Time]. For example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the
trend data to be output are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward
Time] is set to [Auto], trend table data during 30min will be recorded.
[Param.] (Parameter Selection): Select the specific parameter to be output in this menu.
This monitor can display the latest 2,000 sets of NIBP measurement data in NIBP Measurement Review. In
the [Review] menu, select [NIBP Review], as shown in the figure below:
22-3
Data Review
Record Time: Determine which period of trend data will be output via [Start Time] and [Forward
Time]. For example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the
trend data to be output are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward
Select to set and print a NIBP list review report. See the ―Print Setup‖ chapter for details.
This monitor can display the latest 200 parameter alarm events in Alarm Event Review, including
physiological alarm events, technical alarm events, arrhythmia alarm events, and manual events. When an
alarm event occurs, the monitor will save the values of relevant parameters at the moment when such event
occurs and the waveforms 8s before and after such occurrence. In the [Review] menu, select [Alarm Event
Review] to enter the [Alarm Event Review] window → [View Physiology Alarm] → [View Physiology
Alarm] menu, See the figure below:
22-4
Data Review
In [Event] under Alarm Review, user can select the alarm info of the parameter to be viewed.
Warning
Current physiological and technical info can be displayed; upon restart of the monitor, the alarm
info will be cleared.
Alarm info in this window will not be classified by patient.
When the monitor is full of alarm events, the oddest alarm events will be deleted.
Select the physiological alarm event to be viewed and recorded; enter the [View Physiological Alarm]
window to view alarm details; select to directly record current alarm event data.
Select the alarm event to be printed; enter the [View Physiological Alarm] window; select to
22-5
Data Review
Note
Technical alarm can only be viewed and cannot be printed.
You can review holographic waves only after SD card is installed and waves are set to be saved. This monitor
can display single-channel wave playback for maximally 48h in the Wave Review window; with the increase
of waves saved, the playback time for each wave reduces. You can review the waveform of any parameter of
functions configured on the monitor:
22-6
Data Review
Symbol Introduction
Operation Examples
ECG Wave Review:
1) Before admitting a patient, enter the [Wave Save] interface under [User Maintain]; select the waveform
to be saved.
4) In the [Wave Review] window, you can use to view changes in trend graph time and trend curve.
5) Select to enter the [Record Setup] menu. After setting the record start time in this menu, select
22-7
Data Review
6) Select to set and print a wave review report. See the ―Print Setup‖ chapter for details.
22-8
Chapter 23 Calculation
This monitor provides the calculation function. The calculated result is not patient data directly measured, but
is result calculated by the monitor according to appropriate data provided by the user.
Calculations that can be performed on the monitor include:
Drug calculation
Hemodynamic calculation
Ventilation calculation
Oxygenation calculation
Note
Prior to calculation, please confirm whether the correct patient type and calculation unit are
selected. If you have any question, please consult relevant medical workers.
Select the drug dose and calculation method under the doctor’s guidance; the monitor will only
perform calculation according to the input values, but will not verify the calculated results.
After power outage, data in [Review] in the Calculate chapter will be cleared.
The monitor provides the calculation and titration display functions for 15 drugs, and can output the titration
content on the recorder.
Types of drugs that can be calculated in the system include: Aminophylline, Dobutamine, Dopamine,
Epinephrine, Heparin, Isuprel, Lidocaine, Nipride, Nitroglycerin, and Pitocin; besides, drugs A, B, C, D and E
are provided to represent any drug.
23-1
Calculation
In the Drug Calculate window, the operator should first select the name of drug to be calculated; confirm the
patient weight; and then input other known values. Select the position of calculation item to be input; the
corresponding input window will pop up, where you can input the calculated value. After selecting the
calculated value, the result of the calculation item will be displayed at the corresponding position.
Note
The values first provided by the system are only a set of random initial values. The operator
should not take these values as the calculation standard, but should re-input a set of values
appropriate for the patient according to the doctor’s advice.
In the same unit series, the unit base will be adjusted automatically according to the current
input value.
Select the drug type: You can select the drug type among 15 drugs; only one type can be selected for
calculation at a time.
Note
A, B, C, D and E are not real drug names, but are codes of user-defined drugs. However, The
units of these five drugs are fixed; the operator can select the appropriate unit according to the
23-2
Calculation
23.1.2 Titration
To enter the Titration interface, select [Titration] in the [Drug Calculate] menu.
The Titration interface under Drug Calculate is shown in the figure below:
Operation steps:
1) In Titration, select [Basic]; select [Dose], [Infusion Rate] or [Drip Rate];
2) Select [Step] to set the step size. The selectable range is 1~10.
23-3
Calculation
In the [Calculate] menu, select [Hemodynamic]; the menu shown below will pop up.
1) Enter the value to be calculated in [Input]; press the [Calculate] button to obtain the calculated value in
2) Select [Range]; the unit following the parameter will change to the corresponding reasonable numerical
range; you can check whether the calculated value is within the normal range.
3) Select [Review] to review the previously calculated result; in the Review interface, you can select to
Note
Parameters should be input for hemodynamic calculation; when no parameters are input, the
corresponding calculated result will not be displayed.
23-4
Calculation
Height cm Height
Weight kg Weight
SV Ml Stroke volume
23-5
Calculation
EF % Ejection fraction
In the [Calculate] menu, select [Ventilation]; the menu shown below will pop up.
1) Enter the value to be calculated in [Input]; press the [Calculate] button to obtain the calculated value in
2) Select [Range]; the unit following the parameter will change to the corresponding reasonable numerical
range; you can check whether the calculated value is within the normal range.
4) Select [Review] to review the previously calculated result; in the Review interface, you can select to
23-6
Calculation
TV Ml Tidal volume
1) In the [Oxygenation] interface, enter the value to be calculated in [Input]; press the [Calculate] button to
2) Select [Range]; the unit following the parameter will change to the corresponding reasonable numerical
range; you can check whether the calculated value is within the normal range.
3) Select [Press. Unit], [Hb Unit] and [Unit] to change the corresponding unit; the value of relevant
4) Select [Review] to review the previously calculated result; in the Review interface, you can select to
23-7
Calculation
Hb g/L Hemoglobin
RQ / Respiration quotient
Height Cm Height
23-8
Calculation
Weight Kg Weight
In the [Calculate] menu, select [Renal] (Renal Function Calculation); the menu shown below will pop up.
1) Enter the value to be calculated in [Input]; press the [Calculate] button to obtain the calculated value in
2) Select [Range]; the unit following the parameter will change to the corresponding reasonable numerical
range; you can check whether the calculated value is within the normal range.
3) Select [Review] to review the previously calculated result; in the Review interface, you can select to
23-9
Calculation
Cr mol/L Creatinine
Height Cm Height
Weight Kg Weight
23-10
Calculation
23-11
Chapter 24 Record
This monitor uses a thermal arraycorder which supports several record types and can output patient info,
measured data, reviews and at most 3 waves.
Recorder door
Records are divided into the following types according to the ways in which they are triggered:
Real-time record triggered manually
Events: parameter alarm events, arrhythmia alarm events, and manual events
Review data
24-1
Record
To start real-time record, select on the front panel of the monitor or the [Record] quick key.
To start records related to specific functions, select the [Record] button in the current menu or
window.
Select on the front panel of the monitor or the [Record] quick key.
If the timed record function is enabled, the recorder will start recording automatically at the set
interval.
When [Alarm On/Off] and [Alarm Record] of a parameter are both set to [On]; as soon as an alarm
is generated for this parameter, the monitor will be triggered to start alarm recording once.
Open [Main Menu], and select [Record Setup] to enter relevant interface.
Record waves:
The recorder can output at most 3 waves at a time. In the record output setup interface, set Record Waves 1, 2
and 3. These settings apply to real-time record and timed record.
Set the paper speed.
1) In this menu, select [Rt Record Time] (Realtime Record Interval): select among [3s], [5s], [8s], [16s],
24-2
Record
Grid
Select [Grid] and switch it between ―On‖ and ―Off‖. When set to on, grid is printed out by the printer on the
paper; when set to off, grid is not printed out on the paper.
Load the record paper to the thermal recorder (optional) on the right side of the monitor according to the steps
shown in the right figure below:
1) Use the latch lock at the top of the recorder door to open the door.
3) Load new roll paper and fix it onto the paper clip.
4) The roll feeds paper from the bottom; paper runs across the top of the recorder door.
5) At least one inch of paper should extend out of the edge of the door.
Caution
Load paper carefully; otherwise the thermal print head may get damaged.
During output by the recorder, it is not allowed to pull the record paper outward with force;
otherwise the recorder may get damaged.
Do not keep the recorder door open except for paper change or troubleshooting.
24-3
Record
2) Take out the record paper, and cut off the crease part.
After long-term use of the recorder, scraps of paper and impurities will be accumulated on the print head,
which will affect the quality of recording and the service life of print head and roll shaft.
Cleaning:
1) Prior to cleaning, measures should be taken to prevent the device from being damaged by static
electricity.
2) Open the recorder door; take out the record paper, and use a cotton ball to dip an appropriate amount of
alcohol.
4) When the alcohol becomes completely dry, reload the record paper and close the recorder door.
Note
Do not use any materials (e.g., abrasive paper) that can damage the thermal part.
Do not squeeze the thermal print head with force.
24-4
Chapter 25 Print
25.1 Printer
This monitor can output patient reports by connection to the printer via a USB cable and net.
Currently, the monitor supports the following types of printers:
HP Laserjet pro M403n laser printer
Resolution: 300dpi
Single/double-sided: Support both single and double-sided printing, if supported by the printer.
Note
For instructions on the printer, please see the documentation accompanied with the printer.
This monitor may support more printers with the upgrade of the product, for which no prior
notice will be provided. If you have any question about your printer, please feel free to contact
us.
Enter [User Maintain] → [Other Setup] → [Printer Type], select [USB] or [Net].
If you choose to connect the printer via the USB cable, you can set up a report to print directly. If you select
the network printer, you need to set the printer properties: Select the [Main Menu] → [Print Setup] →[Printer
Setup]. In the [Printer Setup] menu, you can make the following operations:
25-1
Print
You can print the following types of reports: Trend Graph, Trend Table, NIBP List, Event Review, Wave
Review, and Realtime Wave.
To print a desired report, select [Main Menu] → [Print Setup]; in the pop-up menu, perform report setup as
appropriate for your need.
To stop report printing, select [Main Menu] → [Print Setup] → [Cancel Print].
In the [Print Setup] menu, select [Trend Table Review Report] to set the following:
Print Time: Determine which period of trend data will be output via [Start Time] and [Forward Time].
For example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the trend data to be
output are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward Time] is set to [Auto]:
if [Type Priority] is set to [Time Priority], a page with time column will be printed; if it is set to [Param.
[Type Priority]: When [Param. Priority] is selected, the column in the output report is parameter; when
[Param.] (Parameter Selection): Select the specific parameter to be output in this menu.
25-2
Print
To set the alarm event review report, select [Main Menu] → [Print Setup] → [Alarm Event Review Report].
Print Time: Determine which period of trend data will be output via [Start Time] and [Forward Time]. For
example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the trend data to be output
are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward Time] is set to [Auto], only one
page of data will be printed.
To set NIBP List Report, select [Main Menu] → [Print Setup] → [NIBP List Report].
Time Setup is similar to that of Alarm Event Review Report. Please see the description in ―Alarm Event
Review Report‖.
To set Trend Graph Review Report, select [Main Menu] → [Print Setup] → [Trend Graph Review Report].
[Time of Page]: User can select the time for printing each page as needed; the time that can be selected is less
than the forward time.
[Param.]: Select the review parameter to be printed.
Time Setup is similar to that of Trend Table. Please see the description in ―Set Trend Table Report‖.
To set Realtime Wave Report, select [Main Menu] → [Print Setup] → [Realtime Wave Report].
[Sweep]: Set the wave output speed; [Auto] means the wave output speed is consistent with the sweep speed
of each wave on the screen.
[Wave Select]: Select the wave to be output in this menu.
To set Wave Review Report, select [Main Menu] → [Print Setup] → [Wave Review Report].
Print Time: Determine which period of review data will be output via [Start Time] and [Duration]. For
example: If [Print Time] is set to 2015-4-21 10:00:00 and [Duration] to [15s], the trend data to be output are
those during 2015-4-21 10:00:00~2015-4-21 10:00:15.
[Gain]: Select the wave print range.
[Sweep]: Set the wave output speed.
[Wave Select]: Select the review wave to be printed.
25-3
Print
When the printer is out of paper, no response will be given to the print request sent; when there are too many
tasks without response, printer abnormality may be caused. At this moment, please properly load paper into
the printer and resend the print request; when necessary, restart the printer.
When the printer status info shows [USB printer not exists], please check to see if the printer is turned on,
connected correctly and loaded with paper.
25-4
Chapter 26 Other Functions
When a physiological parameter of the patient meets the conditions set under [Nurse Call], the Nurse Call
function is triggered. The monitor will make a ―click‖ sound.
Nurse Call Setup:
1) Enter [User Maintain] → [Nurse Call Setup] → [Nurse Call].
[Alarm Type]: Select which type of alarm will trigger Nurse Call.
[Alm Level]: Select which level of alarm will trigger Nurse Call.
Wired connection:
1) Enter [User Maintain] → [Net Protocol] (Network Protocol).
2) Select the (Monitor Setup) shortcut key on the lower menu bar. Enter [Monitor Setup] →
[Network Setup].
3) Set [Net Bed] (Network Bed Number) and [IP Address]. Normally, you only need to set Net Bed and
[Net Bed] is an identification number used by the monitor to communicate with the central
1) Enter [User Maintain] → [Net Protocol], and select the appropriate protocol.
3) Select the (Monitor Setup) shortcut key on the lower menu bar. Enter [Monitor Setup] →
[Network Setup].
4) Enter [WiFi Setup] and select the appropriate network from the Wi-Fi list.
5) Set [Net Bed], [IP Address], [SSID], [Password], etc. Normally, you only need to set Net Bed and leave
26-1
Other Functions
There is a central monitoring system (CMS) icon on the lower menu bar. is shown when the monitor is
not connected to the CMS, and is shown when the monitor is connected to the CMS successfully.
Note
When WIFI is turned on, wired network will be disabled.
Network bed number must be unique in one central monitoring system (CMS).
For details, see the Instruction Manual for Central Monitoring System of our company.
After this monitor is connected to the central monitoring system, [Time Settings] turns to gray,
and you cannot make any operations.
This monitor allows user to format SD card. When [Format SD Card] is selected, all data will be removed.
Therefore, this function should be used with caution. During SD card formatting, all operations on the screen
are disabled. When formatting is finished, the monitor will restart automatically.
Steps for formatting SD card:
1) Enter [User Maintain] → [Format SD Card]. A warning dialog appears, saying [The monitor will auto
restart after formatting SD card! Confirm to format?]. Select [Enter] to format the SD card. The monitor
26-2
Chapter 27 Battery
27.1 Overview
The monitor is equipped with a built-in rechargeable battery. When AC power supply is connected, the battery
can be charged automatically till full no matter whether the device is turned on or not. In the event of
unexpected power outage, the system will automatically use the battery to supply voltage, thus to avoid
interruption of device operation. After AC power supply is cut off, the battery indicator light blinks, indicating
the battery is being used to supply voltage, and device operation will not be affected.
The Battery icon shown on the screen indicates the current battery status;
Note
If the battery is to be left unused for a long period of time, please remove the battery and keep
it properly.
If the device is provided with a built-in battery, the battery must be charged after each use to
ensure sufficient battery reserve.
Warning
Improper replacement of the lithium battery will result in unacceptable risks.
Replacement of the lithium battery by unprofessional personnel may result in risks.
Battery electrolyte is hazardous. In case that battery electrolyte comes into contact with your
skin or enters your eyes, please wash with clean water immediately and seek medical advice.
Please keep the battery out of the reach of children.
When the battery is used for operation, the monitor will power off automatically when the
battery level is low.
27-1
Battery
3) Remove the screws with a screwdriver, and take out the old battery.
4) Install the new battery into the battery case according the anode and cathode symbols.
Warning
Only use battery designated by the manufacturer.
Do not remove the battery when the device is working.
2) Put the battery for optimization in the battery case of the device.
3) When charging the battery, please ensure that the battery is charged uninterruptedly for at least 6h till it is
fully charged.
4) Disconnect AC power supply, and use the battery to supply voltage to the monitor till the monitor shuts
down automatically.
1) First, determine whether the battery is damaged. When the battery icon shows , it indicates the
2) Check whether the battery can be charged normally when connected to AC power supply.
3) Completely disconnect the monitor from the patient and stop all monitoring and measurement.
27-2
Battery
4) When charging the battery, please ensure that the battery is charged uninterruptedly for at least 6h till it is
fully charged.
5) Disconnect AC power supply, and use the battery to supply voltage to the monitor till the monitor shuts
down automatically; meanwhile record the start time and end time of discharging.
7) When the discharging time reduces to less than 50% of the initial value, please replace the battery.
Note
In order to prolong the service life of the rechargeable battery, if the battery is stored for a long
period of time, it is suggested that the battery should be charged every three months to prevent
excessive discharging.
The voltage supply time of the battery depends on the configuration and operation of the
device. For example, frequent NIBP measurement will reduce the voltage supply time of the
battery.
If the battery is obviously damaged or runs out, it should be replaced. Waste batteries should be properly
recycled in accordance with applicable laws and regulations or the rules of the hospital.
Warning
Do not disassemble or short-circuit the battery or place it in fire; otherwise battery fire,
explosion, leakage of hazardous gas or other hazards may be caused.
27-3
Chapter 28 Cleaning and Maintenance
Only materials and methods listed in this chapter that are accepted by the Company can be used for cleaning
or disinfection of the device. For any damage arising from use of unaccepted materials or methods, the
Company will not provide any warranty.
The Company will not assume any liability for the effectiveness of listed chemicals or methods when they are
used as infection control means. For infection control methods, please consult the Infection Prevention
Department or an epidemiologist in your hospital. Besides, please refer to local policies that apply to your
hospital and country.
28.1 Overview
Please keep the device and its accessories dustless. After cleaning, please check the device carefully. If there
is any evidence of ageing or damage, please stop using it immediately. If it is necessary to send back the
device to our company for repair, first clean it. Please observe the following precautions:
Please dilute detergent and disinfectant as specified by the manufacturer, or use a concentration as low as
possible.
Never pour any liquid onto any part or accessory of the device.
Do not use any frictional material, bleaching powder or strong solvent (e.g., acetone or detergent
containing acetone).
Warning
Only use detergents and disinfectants recommended in this Instruction Manual; use of other
detergents and disinfectants will result in damage to the device or safety risks.
Before cleaning the monitor, please power it off and disconnect it from the AC power supply.
Never use EtO (ethylene oxide) to disinfect the monitor.
Never leave any disinfectant on any surface and accessory of the monitor; please use a wet cloth
to clean it immediately.
It is not allowed to use detergent mixture; otherwise hazardous gases will be generated.
This chapter only introduces the methods for cleaning reusable accessories. Disposable
accessories should not be reused after cleaning and disinfection to avoid cross infection.
To protect the environment, disposable accessories must be recycled or dealt with properly.
28-1
Cleaning and Maintenance
After cleaning, if the sensor cable is damaged or shows any evidence of ageing, it should be
replaced with a new cable.
High-temperature sterilization of the monitor and all accessories is not allowed.
Never use any cleaning solution not recommended in this manual; failure to do so may result in
permanent damage to the device, sensor or cable.
Never soak the sensor or connector in any solution for cleaning or disinfection.
In order to prevent the entry of cleaning solution and dust into the ISA gas analyzer via LEGI
port, the Nomoline sampling line should always be connected when cleaning the ISA analyzer.
Never soak the ISA sidestream gas analyzer in any liquid for disinfection.
The Nomoline sampling line is not a sterile device. In order to avoid damage, please do not
sterilize any part of the sampling line under high pressure.
Before cleaning the IRMA sensor, please remove the disposable IRMA airway adapter. Never
disinfect the IRMA sensor or soak it in any liquid.
The IRMA O2 battery and the IRMA airway adapter are not sterile devices. In order to avoid
damage, do not sterilize the device under high pressure.
Caution
If you carelessly pour any liquid onto the device or any accessory, please contact the
maintenance personnel or our Company immediately.
The monitor should be kept clean. It is suggested that the external surface of the housing should be cleaned
frequently; especially in environments with tough conditions or very windy and dusty places, the cleaning
frequency should be increased in order to avoid cross infection, and accessories should be cleaned on a regular
basis. Prior to cleaning, please first consult or understand relevant rules of your hospital on device cleaning.
Cleaning steps:
2) Use a soft cloth dipped with an appropriate amount of detergent to wipe the housing of the device.
3) Use a soft cloth dipped with an appropriate amount of detergent to wipe the display screen of the device.
4) When necessary, you can use a soft, dry cloth to remove residual detergent.
28-2
Cleaning and Maintenance
Part for
Detergent Disinfectant
Cleaning/Disinfection
Housing
Isopropanol (70%), hydrogen
Power cord
peroxide
ECG cable
Isopropanol (70%),
ECG electrode glutaraldehyde solution (2%),
Alcohol-free hand soap, sodium
Temp sensor hypochlorite (bleaching powder sodium hypochlorite
containing chlorine, 3% aqueous
SpO2 sensor
solution), hydrogen peroxide
Mainstream CO2
module Isopropanol (70%)
Warning
Do not squeeze the rubber tube on the cuff.
During cleaning, only wipe the external surface of the connector socket; never wipe its internal
surface.
When cleaning the gasbag, care should be taken not to allow any liquid to flow into the gasbag.
It is forbidden to dry-clean the cuff.
The disposable cuff can be cleaned with soap to control infection.
After cleaning, please reinstall the gasbag into the cuff according to the following steps.
To reinstall the gasbag into the cuff, first put the gasbag at the head of the cuff so that the rubber tube can line
up with the big opening of the long end of the cuff; then vertically curl up the gasbag and insert it into the big
opening of the cuff; hold the rubber tube and the cuff, and shake the entire cuff till the gasbag is in position.
Lead the rubber tube into the cuff, and run it through the liner via the small hole. See the figure below:
28-3
Cleaning and Maintenance
28-4
Chapter 29 Maintenance
Before use of the monitor, or every 6-12 months or after each maintenance or upgrade, a comprehensive
check, including functional safety check, of the device should be carried out by qualified technical
maintenance personnel having received training.
Items for checking should include:
1) Check to see if the operating environment and the power supply for the monitor conform to relevant
requirements.
2) Check to see if the device and its accessories have any mechanical damage.
3) Check to see if the power cord is free from abrasion and has good insulation performance.
4) Check all functions of the device that can be used for patient monitoring, and ensure that the device is in
5) Check to see if all accessories used are those designated by the manufacturer.
7) If the monitor is equipped with a recorder, check to see if the recorder can work normally and if the
8) Check to see if the wiring impedance and the leakage current conform to relevant requirements.
If there is any evidence of functional failure of the device, it is not allowed to use this monitor for patient
monitoring. Please contact our company or a biomedical engineer of your hospital.
All safety checks or maintenance work requiring disassembly of the device should be performed by
professional maintenance personnel; operation by unprofessional personnel may result in malfunction of the
device or safety hazards, and may also endanger personal safety.
Upon request by the user, our company will conditionally provide relevant circuit diagrams to help the user to
repair user-serviceable components of the device by appropriate and qualified technicians.
Warning
The hospital or organization using this monitor should establish a sound maintenance plan;
failure to do so may result in malfunction of the device and unpredictable consequences, and
may also endanger personal safety.
29-1
Maintenance
The following tasks can be fulfilled only by professional maintenance personnel recognized by the Company.
If the following maintenance is needed, please timely contact the maintenance personnel. Prior to test or
maintenance, the device must be cleaned and disinfected.
Test and Maintenance Items Frequency
Carry out safety check according to IEC At least once every two years. After drop of monitor,
60601-1 replacement of power supply or as needed.
ECG synchronism between monitor and
At least once every two years or as needed.
defibrillator
NIBP leakage test At least once every two years or as needed.
It is used to detect whether the NIBP measuring pump leaks. When the NIBP cuff is connected, this button
can be used to activate the NIBP inflation process, so as to detect whether the NIBP gas circuit is in good
airtight condition. If the result of gas leakage test is OK, the system will not give any prompt; if not, a
corresponding error message will be shown in the NIBP info area.
Gas Leakage Test Process:
1) Properly connect the cuff to the NIBP gas hole in the monitor.
4) At this moment, [Leakage Testing] will be shown in the lower part of the NIBP parameter area on the
screen, indicating that the system starts performing the gas leakage test.
5) The system will inflate automatically till the pressure reaches 180mmHg.
6) About 20s later, the system will turn on the deflation valve automatically, indicating that leakage
measurement is finished.
29-2
Maintenance
If no prompt message is shown in the NIBP parameter area, it indicates the system has no gas leakage. If
[Pneumatic Leak...] is shown, it indicates the gas circuit may leak. At this moment, the operator should check
the complete connection to see if there is any looseness. After confirming the connection is correct, perform
the gas leakage test again. If there is still any fault prompt, please contact the manufacturer for repair.
Cylinder
Monitor
Tube
Cuff
Warning
This gas leakage test is different from the content described in EN 1060-1. This is for user to
simply test whether there is gas leakage during NIBP inflation. If, at the end of the test, the
system shows NIBP gas leakage, please contact our company’s service engineer.
The manufacturer recommends use of a calibrated pressure gauge (or mercury sphygmomanometer) with
accuracy higher than 1mmHg. In the [User Maintain] menu, select [NIBP Verify] to start calibration;
meanwhile, this option will change to [Stop NIBP Verify]. If the knob is pressed at this moment, the system
will stop calibration.
Warning
Calibration of NIBP measurement should be performed once every two years (or according to
maintenance rules of your hospital). Please check its performance according to the following
details.
29-3
Maintenance
Tube
1) Enter [User Maintain] → [ECG Calibrate] to set the system to the calibration status; meanwhile, this
2) To stop ECG calibration, you need to return to the [User Maintain] menu and select [Stop ECG Cal].
During ECG calibration, patient monitoring cannot be performed; meanwhile, ―Cal...can't monitor!‖
(Calculating...can't monitor!) will be shown at the bottom left of the device screen.
29-4
Appendix I Accessories
Warning
Use the accessories of designated types only, or the Monitor may be damaged.
To prevent reduced performance and cross infections, please do no reuse any disposable
accessory.
ECG Accessories
Part No. Type Description Service life(year)
040-000908-00 98ME01AD473 3-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000909-00 98ME01AD474 5-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000910-00 98ME01AD475 12-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000911-00 98ME01EB477 3-lead European-standard integral clip-on 2
defibrillation-resistant cable
040-000912-00 98ME01EB478 5-lead European-standard integral clip-on 2
defibrillation-resistant cable
040-000913-00 98ME01EB479 12-lead European-standard integral clip-on 2
defibrillation-resistant cable
040-000479-00 98ME01AC458 3-lead. AHA standard 2
040-000480-00 98ME01AC457 5-lead. AHA standard 2
040-000481-00 98ME01AB076 12-lead. AHA standard 2
040-000485-00 98ME01EC681 3-lead. IEC standard 2
040-000486-00 98ME01EC680 5-lead. IEC standard 2
040-000487-00 98ME01EB075 12-lead. IEC standard 2
040-000914-00 A3105-EC1 3-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000915-00 A5105-EC1 5-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000916-00 A4020-EE1 12-lead American-standard integral clip-on 2
defibrillation-resistant cable
040-000917-00 A3105-EC0 3-lead European-standard integral clip-on 2
defibrillation-resistant cable
040-000918-00 A5105-EC0 5-lead European-standard integral clip-on 2
defibrillation-resistant cable
040-000919-00 A4020-EE0 12-lead European-standard integral clip-on 2
defibrillation-resistant cable
Standard SpO2 Sensor
Part No. Type Description Service life(year)
I-1
Accessories
I-2
Accessories
I-3
Appendix II Product Specifications
1) Monitor Type
Classified by Type
Electric shock protection
Externally powered Class-I equipment; continuous operation equipment
type
Defibrillation-proof
defibrillation resistant equipment with internal power supply.
applied parts
Electric shock protection Equipment with CF applied part (ECG, C.O. and IBP monitoring part) and
level BF applied parts (all other monitoring parts).
IP grade IPX1
Work mode Continuous operation equipment
IEC 60601-1 IEC 60601-1-8 IEC 60601-2-27 EN 1060-3 IEC 80601-2-30
Safety standards
IEC60601-2-34 IEC60601-2-49 ISO 80601-2-56 ISO 80601-2-61
2) Environmental Specifications
Item Specification
Ambient
5℃~40℃
temperature
Working
RH ≤93%
conditions
Barometric
700hPa~1060hPa
pressure
Please protect the monitor against violent impact, vibration, rain and snow in
Transport transport. The monitor should be Transported in a well-ventilated room without corrosive
conditions gas (ambient temperature: -20 ℃ ~60 ℃ ; RH: ≤93%; Barometric pressure:
700hPa~1060hPa).
The monitor should be packed and stored in a well-ventilated room without corrosive gas
Storage conditions (ambient temperature: -20 ℃ ~60 ℃ ; RH: ≤93%; Barometric pressure:
700hPa~1060hPa).
3) Power Supply
Item Specification
AC input voltage 100~240V
AC input frequency 50Hz/60Hz
Power supply Powered either by built-in battery or external AC.
Input power 60VA
Standard: 11.1V/2200mAh rechargeable lithium-ion battery, supplying power for at
least 2 consecutive hours in normal use once fully charged.
Built-in battery
Optional: 11.1V 4400mAh rechargeable lithium-ion battery, supplying power for at
least 4 consecutive hours in normal use once fully charged.
II-1
Product Specifications
11.1V 4400mAh: At least 4 hours from depletion to 90% charge in normal use.
Charge time
11.1V/2200mA: At least 2 hours from depletion to 90% charge in normal use.
Defibrillation output +5V defibrillation synchronization signal during 100ms
Synchronization Max delay: ≤35ms; Pulse width: 100ms±10; Up/Down time≤1ms
4) General Specifications
Item Specification
Dimension About 344mm×291 mm×165mm
Weight About 3.9kg(with battery)
LCD specification Size: 12.1 Inch
Pixel :800×600
5) ECG Specifications
Item Specification
Applicable standards: IEC 60601-2-27.
12-lead (R, L, F, N, C1, C2, C3, C4, C5, C6 or RA, LA, LL, RL, V1, V2, V3, V4,
Lead mode
V5, V6)
Method of leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform 2 -channel
Lead mode 5-lead (R, L, F, N, C; or RA, LA, LL, RL, V)
Method of leads I, II, III, aVR, aVL, aVF, V
Waveform 2 -channel
Lead mode 3-lead ( R, L, F; or RA, LA, LL)
Method of leads I, II, III
Waveform 1-channel
Load 1V, power frequency, differential-mode AC voltage for 10s without damage
Overload protection
(p-v)
Resp, lead
AC waveform:
disconnection
Current :<0.1µA;
detection and active
Frequency 64kHz, ±10%
noise control
Auto identify the type of ECG leads.
Amplitude (p-v RTI) 0.5mV~5mV
Width (adult) 70ms~120ms
Width (neonate/child) 40ms~120ms
QRS wave amplitude
and interval a) with amplitude (p-v RTI) not exceeding 0.15mV
Not respond to the (except in neonate/child mode); or
signals: b) with 10ms width (except in neonate/child mode) in
case of 1mV amplitude.
Triggering threshold
200µV (lead II)
level
Power frequency
>100µV(p-v)
voltage tolerance
Drift tolerance Triangular wave 4mV
II-2
Product Specifications
II-3
Product Specifications
Permanent
25mm/s, 50 mm/s
display
Time reference Time reference
Non-
selection and selection
permanent 6.25mm/s, 12.5mm/s, 25 mm/s, 50 mm/s
accuracy
display
Maximum time
±10%
reference error
Channel width 30mm
Output display
Aspect ratio 0.4s/mV
Use method A and method B in IEC 60601-2-27to determine the total system error
and frequency response.
Total system error ±20% or ±100µV, whichever is larger.
II-4
Product Specifications
HR Calculation
Tall T-wave rejection
1.2mV
capability
As required in Section 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the HR is
calculated as follows. If all of the last 3 RR intervals are longer than 1200ms, the
HR calculation
average of the last 4 RR intervals is the HR. In other cases, the average of the last
12 RR intervals (with the longest interval and shortest interval excluded) is the HR.
As required in Section 201.7.9.2.9.101 b) 4) of IEC 60601-2-27, the HR is
displayed as follows after the 20s stable segment:
Cardiotachometer
Figure 3 a) (bigeminy): 80±1bpm
accuracy and response
Figure 3 b) (slowly varying bigeminy): 60±1bpm
to arrhythmia
Figure 3 c) (quickly varying bigeminy): 120±1bpm
Figure 3 d) (two-way contraction): 90±2bpm
As required in Section 201.7.9.2.9.101 b) 5) of IEC 60601-2-27: the response time
Response time for HR
for a HR change, whether from 80bpm to 120bpm or from 80bpm to 40bpm, is less
changes
than 10s.
As required in Section 201.7.9.2.9.101 b) 6) of IEC 60601-2-27, the waveform:
Figure 4 a) 1 - range: 10s
Figure 4 a) 0.5 - range: 10s
Tachycardia alarm
Figure 4 a) 2 - range: 10s
start time
Figure 4 b) 1 - range: 10s
Figure 4 b) 0.5 - range: 10s
Figure 4 b) 2 - range: 10s
II-5
Product Specifications
6) Resp Specifications
Item Specification
Method Thoracic impedance method
Adult 0rpm~120rpm
RR alarm limit range and
error Neonate/c
0rpm~150rpm
hild
Error ±1rpm
Adult: 110s、15s、20s、25s、30s、35s、40s、45s、50s、
No breath alarm limit Range 55s、1min
range and error Child/neonate: 10s、15s、20s、25s、30s、35s、40s
Error ±5s
No breath alarm delay 10s、15s、20s、25s、30s、35s、40s、45s、50s、55s、1min、Off
The Monitor will display the relevant alarm message when the HR is identical
CVA identification
with the RR.
7) SpO2 Specifications
Item Specification
Display range 0%~100%
Display resolution 1%
Data averaging and other 2s
signal processing time
Data update time 8s
Standard SpO2: measurement range: 0%~100%; measurement accuracy:
±2% (adult/child, in non-motion state) or ±3% (neonate, in non-motion
state) within the measurement range of 70%~100%. The measurement
accuracy within the measurement range of 1%~69% is not defined.
Masimo SpO2: measurement range: 1%~100%; measurement accuracy:
±2% (adult/child, in non-motion state), ±3% (adult/child, in motion state)
Measurement accuracy or ±3% (neonate, in motion or non-motion state) within the measurement
range of 70%~100%. The measurement accuracy within the measurement
range of 1%~69% is not defined.
Nellcor SpO2: measurement range: 0%~100%; measurement accuracy:
±2% (adult/child, in non-motion state) or ±3% (neonate, in non-motion
state) within the measurement range of 70%~100%. The measurement
accuracy within the measurement range of 0%~69% is not defined.
II-6
Product Specifications
Standard SpO2:0%~100%
Alarm limit range and Range Masimo SpO2:1%~100%
accuracy Nellcor SpO2:20%~100%
Accuracy ±1%
Range for Masimo SpO2 and Standard SpO2: 0.02%~20%; accuracy: not
defined.
Perfusion index (PI) Resolution: 0.01% (within 0.02%9.99% range) or 0.1% (within 10.0%20.0%
range).
8) PR Specifications
Item Specification
Standard SpO2 sensor:
Measurement range: 20bpm~254bpm; resolution: 1bpm; measurement
error: ±2bpm.
Masimo SpO2 sensor:
Measurement range: 25bpm~240bpm; resolution: 1bpm; measurement
error: ±3bpm (in non-motion state) or ±5bpm (in motion state).
Nellcor SpO2 sensor:
Measurement range: 20bpm~300bpm; resolution: 1bpm; measurement
Measurement range and
error: ±3bpm within 20bpm~250bpm range. The measurement accuracy
accuracy
within 251bpm~300bpm range is not defined.
NIBP sensor:
Measurement range: 40bpm~240bpm; resolution: 1bpm; measurement
error: ±3bpm or ±3%, whichever is greater.
IBP sensor:
Measurement range: 20bpm~350bpm; resolution: 1bpm; measurement
error within 20bpm~350bpm range: ±1bpm or ±1%, whichever is greater
(excluding the sensor error).
PR alarm limit range and 20bpm~350bmp
accuracy ±1bpm
9) Temp Specifications
Item Specification
Measurement range 0℃~50℃
Measurement range and
accuracy Measurement error ±0.1C (±0.2℉)(include sensor)
II-7
Product Specifications
II-8
Product Specifications
No breath alarm
10s、15s、20s、25s、30s、35s、40s、45s、50s、55s、1min、Off
delay
Respironics/Nmed/Palconn EtCO2
Respironics/Nmed/Palconn EtCO2 sensor (mainstream)
sensor (sidestream)
CO2 0~150mmHg 0~150mmHg
measurement 0%~19.7% 0%~19.7%
range (0~20.0kPa) (0~20.0kPa)
0~69mmHg: 0.1mmHg 0~69mmHg: 0.1mmHg
CO2 resolution
70~150mmHg: 0.25mmHg 70~150mmHg: 0.25mmHg
0~40mmHg: ±2mmHg 0~40mmHg: ±2mmHg
41~70mmHg: ±5%×reading 41~70mmHg: ±5%×reading
CO2 accuracy
71~100mmHg: ±8%×reading 71~100mmHg: ±8%×reading
101~150mmHg: ±10%×reading 101~150mmHg: ±10%×reading
CO2 alarm limit
0~150mmHg 0~150mmHg
range
CO2 alarm
±0.1kPa or ±1mmHg ±0.1kPa or ±1mmHg
resolution
awRR
measurement 0~150rpm 0~150rpm
range
awRR
measurement ±1rpm ±1rpm
accuracy
awRR alarm
0~150rpm 0~150rpm
limit range
awRR alarm
1rmp 1rmp
resolution
Adult:10s、15s、20s、25s、30s、35s、
No breath alarm 40s、45s、50s、55s、1min
Range
limit range and Child/neonate: 10s 、 15s 、 20s 、 25s 、
error 30s、35s、40s
Error ±5s
No breath alarm
10s、15s、20s、25s、30s、35s、40s、45s、50s、55s、1min、Off
delay
II-9
Product Specifications
Systolic
5.3-26.7kPa (40-200mmHg)
pressure
Measurement range Diastolic
1.3-20kPa (10-150mmHg)
(child) pressure
Mean
2.7-22kPa (20-165mmHg)
pressure
Systolic
5.3-18kPa (40-135mmHg)
pressure
Measurement range Diastolic
1.3-13.3kPa (10-100mmHg)
(neonate) pressure
Mean
2.7-14.7kPa (20-110mmHg)
pressure
Measurement Maximum average deviation: ±5mmHg (±0.667kPa);
accuracy maximum standard deviation: ±8mmHg (±1.067kPa).
Adult mode 297mmHg
Overpressure protection Child mode 240mmHg
range and tolerance Neonate mode 147mmHg
Tolerance ±3mmHg
Systolic
5.3kPa~36kPa (40mmHg~270mmHg)
pressure
Diastolic
Adult 1.3kPa~28.7kPa (10 mmHg~215mmHg)
pressure
Mean
2.7kPa~31.3kPa (20mmHg~235mmHg)
pressure
Systolic
5.3kPa~26.7kPa (40mmHg~200mmHg)
pressure
Diastolic
Alarm limit range and Child 1.3kPa~20kPa (10mmHg~150mmHg)
pressure
error
Mean
2.7kPa~22kPa (20mmHg~165mmHg)
pressure
Systolic
5.3kPa~18kPa (40mmHg~135mmHg)
pressure
Neonat
Diastolic
e 1.3kPa~13.3kPa (10 mmHg~100mmHg)
pressure
Mean
2.7kPa~14.7kPa (20mmHg~110mmHg)
pressure
Error ±0.1kPa or ±1mmHg, whichever is greater.
Manual, auto (cyclic) or continual (not applicable to neonates)
1/2/2.5/3/4/5/10/15/30/60/90/120/180/240/480/720m
NIBP measurement mode Interval for auto mode
in
Continual 5min
Initial pressure range
Adult:80~280;Child:80~210;Neonate:60~140
(mmHg)
II-10
Product Specifications
II-11
Product Specifications
P4 -50mmHg~300mmHg
LV 0mmHg~300mmHg
AO 0mmHg~300mmHg
UAP 0mmHg~300mmHg
BAP 0mmHg~300mmHg
FAP 0mmHg~300mmHg
UVP -10mmHg~40mmHg
IAP -10mmHg~40mmHg
IBP alarm error ±0.1kPa or ±1mmHg
Sensitivity: 5V/V/mmHg
Pressure sensor
Impedance range: 300~3000Ω
Pressure zero calibration Each channel should feature a pressure zero calibration function, with an
accuracy of ± 1mmHg or ± 0.1kPa.)
14) AG Specifications
Item Specification
The AG module complies with ISO 80601-2-55.
AG measurement method Infrared radiation absorption characteristics
II-12
Product Specifications
1013±40hPa.
0%~15% ±(0.2kPa+reading×2%)
CO2
15%~25% Not defined.
N2O 0~100 % ±(2 kPa+reading×2%)
0~8 % ±(0.15 %+reading×5%)
Hal, Enf, Iso
8~25 % Not defined.
0~10 % ±(0.15 %+reading×5%)
Sev
10~25 % Not defined.
0~22 % ±(0.15 %+reading×5%)
Des
22~25 % Not defined.
O2 0~100 % ±(1%+reading×2%)
RR 0~254rpm ±1rpm
CO2: 1mmHg
AG resolution
awRR: 1rpm
AG gas name
CO2, O2, N2O, one of the five anesthetic gases (Enf, Iso, Sev, Hal or Des)
EtHal/EtEnf/EtIs
0%~25% ±0.1%
o/EtSev/EtDes
FiHal/FiEnf/FiIs
0%~25% ±0.1%
o/FiSev/FiDes
Item Specification
Specifications of ISATM (AG) Sidestream Gas Analyzer
Measurement
Infrared gas measurement
method
II-13
Product Specifications
For adult: 10s, 15s, 20s, 25s, 30s, 35s, 40s ,45s, 50s, 55s or 1min;
[No Breaths Range
For pediatric and neonate: 20s, 25s, 30s, 35s or 40s
Timeout]
Error ±5s
[No Breath
10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 1min or Off
Alm Delay]
General Specifications
Ultra-small low-flow sidestream gas analyzer, with integrated micro-pump, zeroing valve
Description
and flow controller.
Working
ISA AX+: 0~50°C (32~122°F); ISA OR+: 5~50°C (41~122°F)
conditions
Storage
-40~70°C (-40~158°F)
conditions
RH <4kPa H2O (non-condensing) 95% RH, 30°C
Barometric
52.5~120kPa (4572m)
pressure
Water
Sampling tube: patented dehydration tube
treatment
Data Output
Fi/Et value CO2, O2, N2O, five anesthetic gases (Hal, Enf, Iso, Sev, Des)
Waveform Display up to 4 gas concentration waveforms at a time
Diagnostic
Barometric pressure
parameter
Gas Analyzer
ISA sensor 2~9-channel NDIR gas analyzer (measurement range: 4~10µm)
Compensation CO2 broadening effect
No calibration is required. The Monitor will auto perform zeroing when powered on and
Calibration
perform auto zeroing every 24h (ISACO2) or 8h (ISA AX+/OR+) subsequently.
Preheating time ISA OR+/AX+: < 20s
Gas
Rise time CO2: ≤250ms; N2O: ≤ 350ms; anesthetic gases: ≤ 350ms; O2: ≤450ms
Overall system
<3s (2m sampling tube)
response time
Respiration
Self-adaptive threshold (minimum CO2 concentration change: 1 vol%)
detection
RR 0-150 breaths/min
Anesthetic gas Threshold of main anesthetic gases (ISA OR+/AX+): 0.15 vol%. The concentration of
threshold any identified anesthetic gas will be reported, even if it is lower than 0.15 vol%.
Effects of Interfering Gases and Water Vapor
Gas CO2
Anesthet
Gas or water vapor Concentrati N2O
ISA CO2 ISA AX+ ic Gas
on
4)
N2O 60 vol% _2) _1) _1) _1)
Hal 4) 4 vol% _1) _1) _1) _1)
4) 3) 1) 1)
Enf, Iso, Sev 5 vol% Reading+8% _ _ _1)
Des 4) 15 vol% Reading+12%3) _1) _1) _1)
II-14
Product Specifications
HR: 40~250bpm
Measurement range SV: 5~250mL
C.O.:1.4~15L/min
SV: not defined.
Measurement accuracy HR: ±2bpm.
C.O: no defined.
SV: 0.1ml
Resolution HR: 1bpm
C.O: 0.1L/min
II-15
Product Specifications
Number of waveforms 3
II-16
Appendix III System Alarm Messages
Here we list some of the most important physiological and technical alarm messages.
―XX‖ represents HR, ST, RR, Temp (Temp1, Temo2 and TD), SpO2, PR, CO2 (AwRR, INS and Fi), NIBP,
IBP or any other module name or physiological parameter in the system.
If the problem still exists after you implement the relevant solution provided below, please contact our
maintenance engineers.
Technical alarm types: A (fully clearable), B (the alarm sound and indicator are clearable) or C (not fully
clearable).
The level of each technical alarm is not adjustable (except ECG and SpO2).
1) Physiological Alarm Messages
Default Adjustable
Source Cause Solution
Level Level
ECG
High, medium,
XX too high Medium
low
High, medium,
XX too low Medium
low
―XX‖ represents ST, ST-I, ST-II, ST-III, ST-aVR,
ST-aVL, ST-aVF, ST-V, ST-V1, ST-V2, ST-V3, ST-
V4, ST-V5 or ST-V6.
HR too high Medium High, medium
III-1
System Alarm Messages
SpO2
NIBP
III-2
System Alarm Messages
Temp
High, medium,
T1 too high Medium
low
High, medium,
T1 too low Medium The measured value is Check the patient’s
low
greater than the upper physiological condition and
High, medium,
T2 too high Medium alarm limit or smaller check if the selected patient
low
than the lower alarm type and alarm limit are
High, medium, limit. applicable to the patient.
T2 too low Medium
low
High, medium,
TD too high Medium
low
CO2
FiCO2 too high Medium unadjustable The measured value is Check the patient’s
greater than the upper physiological condition and
FiCO2 too low Medium unadjustable
alarm limit or smaller check if the selected patient
EtCO2 too high Medium unadjustable than the lower alarm type and alarm limit are
III-3
System Alarm Messages
High, medium,
AwRR too high Medium
low
High, medium,
AwRR too low Medium
low
INS too high Medium unadjustable
AG
III-4
System Alarm Messages
High, Medium,
EtHal. too high Medium
Low
High, Medium,
EtHal. too low Medium
Low
High, Medium,
EtIso. too high Medium
Low
High, Medium,
EtIso. too low Medium
Low
High, Medium,
EtEnf. too high Medium
Low
High, Medium,
EtEnf. too low Medium
Low
High, Medium,
EtSev. too high Medium
Low
High, Medium,
EtSev. too low Medium
Low
High, Medium,
EtDes. too high Medium
Low
High, Medium,
EtDes. too low Medium
Low
C.O.
High, Medium, Check the patient
BT too high Medium
Low The measurement data condition, the patient type
High, Medium, is out of the limit setting in the monitor and
BT too low Medium
Low the alarm limit.
BIS
High, Medium, Check the patient
BIS too high Medium
Low The measurement data condition, the patient type
High, Medium, is out of the limit setting in the monitor and
BIS too low Medium
Low the alarm limit.
ICG
High, Medium,
C.I. too high Medium
Low
High, Medium, Check the patient
C.I. too low Medium
Low The measurement data condition, the patient type
High, Medium, is out of the limit setting in the monitor and
TFC too high Medium
Low the alarm limit.
High, Medium,
TFC too low Medium
Low
III-5
System Alarm Messages
III-6
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
resetting system is resetting. exists after you restart
the Monitor, please
contact us for service.
The SpO2 sensor is Check the patient’s
Search connected unreliably condition and if the
Low B
pulse or the patient moves SpO2 sensor is
his/her arm. connected properly.
III-7
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
(Masimo) service.
SpO2
module The module has a Return to us for
Low C
error fault. repair.
(Masimo)
Temp1
Low A Check if the Temp
sensor off The Temp sensor is
Temp sensor is connected
Temp2 connected unreliably.
Low A properly.
sensor off
An error occurs in the
NIBP Enable the reset
High A NIBP module
selftest error function in the NIBP
initializing process.
menu. If the error still
The NIBP
NIBP comm exists, contact us for
High A communication part
error service.
has a fault.
The NIBP cuff is Reconnect the NIBP
Loose cuff Low A
connected unreliably. cuff.
Pneumatic The NIBP air circuit
Low A
leak leaks air.
An error occurs in the
measurement process.
Pressure
Low A The system fails to do
overrange
measurement, analysis Check the connection
and calculation. condition of each part
The NIBP cuff is or replace the NIBP
connected unreliably cuff. If the fault still
NIBP Air leak Low A
or the air circuit leaks exists, contact us for
air. service.
An error occurs in the
measurement process.
Air pressure
Low A The system fails to do
error
measurement, analysis
and calculation.
An error occurs in the Check if the selected
measurement process. patient type is correct.
Weak signal Low A The system fails to do Check the connection
measurement, analysis condition of each part
and calculation. or replace the NIBP
The NIBP cuff is cuff. If the fault still
Cuff type
Low A incompatible with the exists, contact us for
error
selected patient type. service.
Excessive The patient moves Check the patient’s
Low A
motion his/her arm. condition and the
III-8
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
Signal connection condition
Low A
saturated of each part, and then
NIBP try the measurement
system High A An error occurs in the again. If the fault still
failure measurement process. exists, contact us for
NIBP The system fails to do service.
measure Low A measurement, analysis
timeout and calculation.
NIBP
measure Low A
failed
Check the patient’s
condition and if the
air circuit is
Over The air circuit is unobstructed, and then
Low A
pressure folded. try the measurement
again. If the fault still
exists, contact us for
service.
Check if the NIBP air
circuit is clogged and
NIBP reset Illegal reset occurs in then try the
Low A the NIBP
error measurement again. If
measurement process. the error still exists,
contact us for service.
IBP1 lead Check or reconnect
off The IBP sensor is in the IBP sensor. If the
IBP Low B
IBP2 lead poor contact. fault still exists,
off contact us for service.
[Standby] is selected
CO2 is Select [Measure] as
Low C as the CO2 work
sleeping the CO2 work mode.
mode.
CO2
The sampling tube is
sampling Low B
clogged. Check and replace the
line clogged
sampling tube. If the
CO2 no
The sampling tube is fault still exists,
CO2 sampling
Low B in poor contact or not contact us for service.
line
connected.
(Masimo)
The measured value
CO2 out of
goes beyond the Follow the specified
accuracy Low C
specified accuracy accuracy range.
range
range.
CO2 Temp Low C The module has a Return to us for
III-9
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
out of range fault. repair.
CO2 span
cal error Low C
(Masimo)
CO2 factory
calibration
Low C
lost
(Masimo)
CO2 speed
out of
Low C
bounds
(Masimo)
CO2
pressure
Low C
overrange
(Masimo)
CO2 span
The CO2 span is being
calibrating... Low C Return to us.
calibrated.
(Masimo)
Replace
The adapter has a
adapter Low C Check and replace the
fault.
(Masimo) adapter. If the fault
The adapter is in poor still exists, contact us
No adapter
Low C contact or not for service.
(Masimo)
connected.
CO2 Need
The CO2 module Enter [CO2 Setup] to
Zero Low C
needs zeroing. select [Zero].
(Masimo)
Software
The software has a
error Low C Restart the Monitor.
fault.
(Masimo)
III-10
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
alarm Connect the Monitor
message to the AC power
s supply to charge the
The battery power is
Low battery Medium B battery. If the fault
low.
still exists after 6-hour
charging, contact us
for service.
Low The battery power is Connect the Monitor
battery, shut so low that the system to the AC power
High C
down in is forced to shut supply to charge the
xxS down. battery.
AG is AG analyzer is in
Low B None。
Zeroing calibration
Need Air Oxygen sensor need Calibrate oxygen
Low A
Calibrate be calibrated in air sensor in 21% air
Calibrate oxygen
sensor in pure oxygen.
Need O2 Oxygen sensor need
If user can’t meet the
Span Low A to be calibrated in
requirement, please
Calibrate pure oxygen
return it back to
factory
O2 Sensor
Low C
Error
O2 Port
Low C Reseat oxygen sensor
Failure module fails
or reboot.
Hardware
Error,Repla High A
AG ce Sensor
Sampling check and replace the
sampling tube
Line Low C sampling tube, if the
blocking
Clogged fault persists, please
AG No ampling tube is not contact the
Sampling Low A connected or in bad manufacturer for
Line contact. maintenance.
Replace check and replace the
Medium C adapter abnormal
Adapter adapter, if fault
persists, please
adapter is not
contact the
No Adapter Low A connected or in bad
manufacturer for
contact.
maintenance.
CO2 Out Of Please follow the
the measured value
Accuracy Low A precision range of
exceeds the claimed
Range measurement claimed
scope of accuracy
O2 Out Of Low A by manufacturers
III-11
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
Accuracy
Range
N2O Out Of
Accuracy Low A
Rang
AX Out Of
Accuracy Low A
Range
AG Temp
Out Of Low C
Range
Pressure
Medium C
Overrange
Factory
Calibration Low C
Lost
enter AG settings for
AG Need AG Analyzer requires
Low C zero Here zero is
Zero zero
equal to calibration.
AG Analyzer does not
AG
recognize the
Conc.Unreli Low C check the gas.
existence of
able
other gas
Replace O2 replace oxygen
Low C beyond usage time
Sensor sensor.
Software
Low C software error occurs./ Reboot
Error
There is only one
main nesthetic gas check the patient's
Found Two
Medium B waveform and value physiological signs
AG Gases
shown in the kinds of and anesthesia.
anesthesia gas for tips.
AG Analyzer measurement mode of
AG Is
Low B operating mode is on AG Analyzer is
Sleeping
standby. selected.。
Poor connection
BT No Check and reconnect
C.O. Low B between the BT probe
Sensor the BT probe
and monitor
III-12
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
Poor connection
IT No Check and reconnect
Low B between the IT probe
Sensor the IT probe
and monitor
Cool the injection, for
example. Put the
IT The temp is greater bottom of tube fitted
Low C
Overrange than 30℃ with injection in ice
water to cool the temp
down
After ―start‖, the time
Inject The injection time is
Low A should be shorter than
Timeout too long
4s
C.O.
Baseline Low A Do not place the
Might be interfered by
Drift monitor close to the
electrosurgical high
C.O. electrosurgical high
frequency device
Baseline Low A frequency device
Noise
Check if the BIS
sensor is connected
BIS No BIS sensor is
Low B properly. If the fault
Sensor connected unreliably.
still exists, contact us
for service.
Prompt information
Checking for ten-minute ground
BIS Low B No action necessary
Impedance electrode impedance
check
Reinitialize BIS
module. If there is still
BIS Comm Data communication malfunction, please
High C between monitor and
Stop contact the
BIS module stops manufacturer to
maintain it.
The initialization of
sensor can be still
BIS Sensor Sensor is out of its
Low B conducted and the
Expired service life
data waveform data
and parameter can be
III-13
System Alarm Messages
Alarm Alarm
Source Alarm Type Cause Solution
Message Level
also captured. This
alarm merely reminds
the users that this
sensor is out of
service life, but it
depends on users
whether to replace it.
Invalid BIS
Low C Invalid sensor
Sensor
During the process of
initialization and
monitoring, the sensor
Change Sensor
Change over current and
Low C
Sensor incorrect ground
impedance have been
detected by the
system.
Low Signal
Quality
Low B Weak signal SQI value is too low.
(SQI ﹤
Check the status of
50%)
patient and the
Poor
connection of sensor.
Signal(SQI Low B Poor Signal
﹤15%)
ICG Sensor ICG sensor is
Low A Check if the ICG lead
Off connected unreliably.
is connected properly.
ICG The ICG lead is
ICG Lead If the fault still exists,
Low A connected
Off contact us for service.
unreliably.。
Calibrating... None
A system prompt message can
Leakage testing... None indicate that the Monitor is
NIBP
Resetting... None performing a certain function or
operation.
Continual measuring... None
III-14
System Alarm Messages
Prompt
message for
Unload module None
module
unloading
III-15
System Alarm Messages
Ip conflict None
Sampling None
Relearn None
Demo None
III-16
Appendix IV Default Settings
Here we list the configurations for different departments in configuration management and some of the most
important default settings. You have no permission to change the default settings. However, you can change
the settings as needed and save them as user-defined settings.
1) General Configurations
1. Alarm
Item General OR ICU NICU CCU
Alm vol 2
Alm rec time 8s
2. Module Color
Item General OR ICU NICU CCU
ECG Green
SpO2 Cyan
Resp Yellow
NIBP White
Temp White
CO2 Yellow
Waveform/p
IBP Red
arameter
CO2(AG) Yellow
color
O2 White
AA Red
N2O Blue
ICG purple
C.O. White
BIS Green
3. Review
Item General OR ICU NICU CCU
Trend graph resolution 1s
Trend table resolution 1min
4. Layout
Item General OR ICU NICU CCU
Screen select Standard
Default: main menu – alarm reset – NIBP start – screens – review –
Quick key
alarm setup – standby
Waveform 1 ECG1
sequence on 2 ECG2
IV-1
Default Settings
5. Event Setup
Item General OR ICU NICU CCU
Waveform 1 I
Waveform 2 II
Waveform 3 PLETH
6. Record
Item General OR ICU NICU CCU
Waveform 1 II
Waveform 2 I
Waveform 3 Off
Waveform record output
speed 25mm/s
RT record time 8s
Timed record interval Off
Grid On
7. Maintain
Item General OR ICU NICU CCU
Wave draw Mono
Wave line Thin
Analog out Off
Alm mute Off
Reminder
1min
interval
Reminder
Alarm 1
volume
setup
Min. Alm
2
volume
Alm pause time 2min
Alm delay time Not allowed
IV-2
Default Settings
IV-3
Default Settings
2) Default Settings
1. Default ECG Settings
Item General OR ICU NICU CCU
Cascade Off
Lead name II
Gain X1
Sweep 25mm/s
Channel format 2x6+1
Filter mode Monitor
Lead type 5-lead
Calculate lead II
HR source ECG
Alarm On
Alm record Off
PF inhibition On (50HZ)
Smart lead off Off
Note: refer to Table 8 in Section 1) General Configurations for default HR
HR alarm limit
alarm limit.
2. Default ST Settings
Item General OR ICU NICU CCU
ST analysis Off
Alarm Off
Alm level Medium
Alm record Off
Alm limit (-0.20, 0.20)
3. Default Resp Settings
Item General OR ICU NICU CCU
Gain X1
Enhance filter On
Sweep 12.5mm/s
Apnea alarm 20s
Resp lead RA-LL(II)
Alarm On
Alm level Medium
Alm record Off
ADU
(8 --- 30)
Alm limit PED
NEO (30--- 100)
IV-4
Default Settings
6. Default PR Settings
Item General OR ICU NICU CCU
Alarm On
Alm record Off
PR source SpO2
Alm level High
PR Alm limit Refer to Table 8 in Section 1) General Configurations for default PR alarm
IV-5
Default Settings
limit.
ADU
(36.0 --- 39.0)
T1 Alm limit PED
NEO
ADU
(36.0 --- 39.0)
T2 Alm limit PED
NEO
ADU
TD Alm
PED (0 .0 --- 2.0)
limit
NEO
IV-6
Default Settings
(Nmed/Palconn)
Altitude unit m
Altitude (Nmed/Palconn) 0.0m
Baro. pressure 760mmHg
N2O compensate
(Masimo) Off
No breaths timeout 20s
Alarm On
Alm record Off
CO2 Alm limit (30 --- 45)
INS Alm limit (0 --- 4)
Refer to Table 8 in Section 1) General Configurations for default
AWRR(CO2) Alm limit AWRR(CO2) alarm limit.
PA
LAP
Sweep 25 mm/s
Alarm On
ART, P1, P2, P3, P4, LV, Ao, UAP, BAP and FAP Setup
IV-7
Default Settings
PA Setup
NEO
NEO
NEO
NEO
O2 compensate High
Alarm On
IV-8
Default Settings
IT Source Manual
Measurement Interval 5s
Alarm On
Scale 250uV
Sweep 25mm/s
Filter On
Alarm On
IV-9
Default Settings
Sweep 25mm/s
Alarm On
IV-10
Appendix V EMC
Note
The monitor complies with the applicable EMC requirements in IEC60601-1-2.
Please follow the EMC instructions in the User’s Manual to install and use the Monitor.
Portable and mobile RF communication equipment may affect the performance of the monitor.
To protect the Monitor against strong electromagnetic interference, please keep it away from
mobile phones, microwave ovens, etc.
Refer to the attached guide and manufacturer’s statement.
Warning
Do not stack this product on/under or get it close to any other equipment. If you have to use it
this way, observe and verify whether it works properly in such condition first.
Class-A equipment are intended to work in industrial environments. Considering this product’s
conduction disturbance and radiation disturbance, it may be difficult to ensure its EMC in non-
industrial environments.
Using any accessory or cable other than sold by the manufacturer as spare parts may cause
higher electromagnetic emission or lower electromagnetic immunity.
Table 1
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.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The monitor uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class A The monitor is suitable for use in all establishments
CISPR 11 other than domestic and those directly connected to
Harmonic emissions the public low-voltage power supply network that
Class A
IEC 61000-3-2 supplies buildings used for domestic purposes.
Voltage fluctuations/
Complies
flicker emissions
IEC 61000-3-3
V-1
EMC
Table 2
declaration - electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 or ceramic tie. If floors are
IEC 61000-4-2 ±15 kV air kV, ±15 kV air covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast ± 2 kV for power supply ± 2 kV for power
Mains power quality should be
transient/burst lines supply lines
that of a typical commercial or
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for
hospital environment.
lines input/output lines
100 kHz repetition 100 kHz repetition
frequency frequency
Surge ±0.5kV, ±1 kV line(s) to ± 0.5kV, ± 1 kV
Mains power quality should be
IEC 61000-4-5 lines line(s) to lines
that of a typical commercial or
± 0.5kV, ± 1 kV, ± 2 kV ± 0.5kV, ± 1 kV, ±
hospital environment.
line(s) to earth 2 kV line(s) to
earth
Voltage dips, 0 % UT; 0.5 cycle At 0°, 0 % UT; 0.5 cycle
Mains power quality should be
short 45°, 90°, 135°, 180°, At 0°, 45°, 90°,
that of a typical commercial or
interruptions and 225°, 270°and 315° 135°, 180°, 225°,
hospital environment. If the user
voltage 270°and 315°
of the monitor requires continued
variations on 0 % UT; 1 cycle and
operation during power mains
power supply 70 % UT; 25/30 cycles 0 % UT; 1 cycle
interruptions, it is recommended
input lines Single phase: at 0° and
that the monitor be powered from
IEC 61000-4-11 70 % UT; 25/30
an uninterruptible power supply
0 % UT; 250/300 cycles cycles
or a battery.
Single phase: at 0°
0 % UT; 250/300
cycles
Power frequency 30 A/m(50/60 Hz) 30 A/m Power frequency magnetic fields
magnetic field should be at levels characteristic
IEC 61000-4-8 of a typical location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
V-2
EMC
Table 3
declaration - electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic
level level environment - guidance
Conducted RF 3V 3V Portable and mobile RF communications
IEC 61000-4-6 0.15 MHz to 80 0.15 MHz to equipment should be used no closer to any part
MHz 80 MHz of the monitor, than the recommended
6 V in ISM and 6 V in ISM separation distance calculated from the
between 0.15 MHz and between equation applicable to the frequency of the
and 80 MHz 0.15 MHz transmitter.
and 80 MHz Recommended separation distance
Radiated RF 3V/m 3V/m 3.5
IEC 61000-4-3 80 MHz to 2.7 d P 150 KHz to 80 MHz
GHz V 1
3.5
d P 80 MHz to 800 MHz
E1
7
d P 800 MHz to 2.7 GHz
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 meters
(m).
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 RF transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the monitor is used exceeds the applicable RF compliance level
above, the monitor should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the monitor.
V-3
EMC
b Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4
Recommended separation distances between
portable and mobile RF communications equipment and the monitor
The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the monitor can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the monitor, as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter m
W 0.15 MHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
d 1.2 P d 1.2 P d 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer
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.
V-4
EMC
Table 5
declaration - IMMUNITY to proximity fields from RF wireless communications equipment
The monitor is intended for use in an electromagnetic environment in which RF wireless
communications equipment are controlled.
Immunity IEC60601 test level Compliance Electromagnetic
test level environment -
Test Modulation Maximum Immunity
guidance
frequency power level
Radiated 385 MHz **Pulse 1.8W 27 V/m 27 V/m
RF Modulation:
IEC 18Hz
61000-4-3 450 MHz *FM+ 5Hz 2W 28 V/m 28 V/m
deviation:
1kHz sine
710 MHz **Pulse 0.2 W 9 V/m 9 V/m
745 MHz Modulation:
780 MHz 217Hz
810 MHz **Pulse 2W 28 V/m 28 V/m
870 MHz Modulation:
930 MHz 18Hz
1720 MHz **Pulse 2W 28 V/m 28 V/m
1845 MHz Modulation:
1970 MHz 217Hz
2450 MHz **Pulse 2W 28 V/m 28 V/m
Modulation:
217Hz
5240 MHz **Pulse 0.2 W 9 V/m 9 V/m
5500 MHz Modulation:
5785 MHz 217Hz
V-5
Appendix VI Toxic/Hazardous Substances/Elements
VI-1