S8 - User Manual
S8 - User Manual
Copyright
Version: A
Product Name: Defibrillator/Monitor
No.:046-001599-00
Statement
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.
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User Manual for Defibrillator Monitor
Preface
This manual provides details on the performance, operations and safety instructions of User Manual for the
defibrillatormonitor (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.
Basic Performance
What is claimed to be determined as basic performance is:
1) Defibrillation energy release accuracy of defibrillation monitor;
4) HR detection accuracy;
I-2
User Manual for Defibrillator Monitor
Contents
Chapter 1 Safety ............................................................................................................................................... 1-1
1.1 Safety Information .................................................................................................................................. 1-1
1.2 Contraindications.................................................................................................................................... 1-3
1.3 Symbols .................................................................................................................................................. 1-4
Chapter 2 Overview.......................................................................................................................................... 2-1
2.1 Product Introduction ............................................................................................................................... 2-1
2.1.1 Intended Use .................................................................................................................................... 2-1
2.1.2 Components ..................................................................................................................................... 2-1
2.2 MonitorViews ......................................................................................................................................... 2-2
2.2.1 Front View ....................................................................................................................................... 2-2
2.2.1.1 Area 1 ....................................................................................................................................... 2-3
2.2.1.2 Area 2 ....................................................................................................................................... 2-4
2.2.1.3 Area 3 ....................................................................................................................................... 2-4
2.2.1.4 Area 4 ....................................................................................................................................... 2-5
2.2.2 Right View ...................................................................................................................................... 2-6
2.2.3 Left View ......................................................................................................................................... 2-7
2.2.4 Rear View ........................................................................................................................................ 2-8
2.2.5 External Defibrillation Electrode Paddle ......................................................................................... 2-9
2.3 OSD (On-screen Display)....................................................................................................................... 2-9
2.4 Operating Mode .................................................................................................................................... 2-11
2.4.1 Manual Defibrillation Mode .......................................................................................................... 2-12
2.4.1.1 MonitorMode.......................................................................................................................... 2-12
2.4.2 Pacer Mode .................................................................................................................................... 2-12
2.4.3 AED Mode .................................................................................................................................... 2-12
Chapter 3 Installation ....................................................................................................................................... 3-1
3.1 Unpacking and Checking ....................................................................................................................... 3-1
3.2 Connection of AC Power Cord............................................................................................................... 3-2
3.3 Start-up ................................................................................................................................................... 3-2
3.4 Connecting the Sensor or Patient Cable ................................................................................................. 3-3
Chapter 4 Patient Safety ................................................................................................................................... 4-1
4.1 Safety Instructions .................................................................................................................................. 4-1
4.2 Environmental Requirements ................................................................................................................. 4-1
4.3 Protective Grounding.............................................................................................................................. 4-1
4.4 Equipotential Grounding ........................................................................................................................ 4-1
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
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User Manual for Defibrillator Monitor
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User Manual for Defibrillator Monitor
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User Manual for Defibrillator Monitor
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User Manual for Defibrillator Monitor
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User Manual for Defibrillator Monitor
I-10
Chapter 1 Safety
Danger
To indicate the dangers which would result in death or severe personal injury.
Warning
Alerts you to the 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 the 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
Before using, you must check the monitor and its accessories to ensure that theycan work
normally and safely.
Do not conduct therapy on patients lying on wet ground.
When conducting therapy on patients with pacemaker, the pads or paddles should be placed
away from the pacemaker.
Donot place the power outlet out of the operator’s reach.
Alarm volume and high/low 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. Pay close attention to the patient’s actual clinical conditions is the most
reliable monitoring way.
1-1
Safety
The monitor can only be connected to a power outletwith protective ground. If the power
socket is not connected to a ground conductor, use the rechargeable battery to supply power to
the monitor instead of using thepower outlet.
Donot open the housing of the monitor to avoid the potential risk of electric shock. The monitor
must be maintained and upgraded by service technician trained and authorized by our
company.
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.
Do not use the monitor inthe presence of flammableanesthetics or other flammable substance
in combination with air, oxygen-enrichedenvironments, or nitrous oxide.
To ensure safety, avoid stacking multiple equipment or placing anything on the monitorduring
operation.
Carefully place the monitor power cord and accessories cables to avoid entanglement,potential
strangulation, and electrical interference to the patient.
To protect you from electric shock, always remove the sensor and completely disconnect the
monitor before bathing the patient.
For patients with pacemakers, the cardiotachometer may be used to record pacemaker pulse in
the event of asystole or arrhythmia. Donot completely rely on the alarm function of the
cardiotachometer. Patients with pacemakers must be closely monitored. For the pacemaker
inhibiting function of the monitor, please refer to relevant section in this Manual.
Keep patient under close suveillence when using this monitor to conduct therapy. If the shock is
delayed, the shockable rhythm may change to nonshockable rhythm, leading to delivering
wrong shock.
The equipment withoutdefibrillation protection shall be disconnected from the patient during
defibrillation.
During defibrillation, the operator shouldnot come into contact with the patient, the monitor or
the supporting table; otherwise may result in serious injury or death. Before reusing the cables,
check to confirm that their functions are normal.
Any equipment connected to the monitor shall form an equipotential body (effective connection
of protective ground).
In order to avoid burns (resulted from electric leakage) to the patient, ensure thatthe monitor’s
sensors and sensor cables never come into contact with any high-frequency electrosurgical
equipment.
The physiological waveform and parameter, alarm message and other information displayed
by the monitor are only for reference by physicians, and not directly used as a basis for clinical
treatment.
Electromagnetic field can affect the performance of the monitor. Therefore, equipment used
near the monitor should conform to the applicable EMC requirements. For example, mobile
phones and X-ray machines are potential sources of interference, since they transmit high-
intensity electromagnetic radiation.
1-2
Safety
Do not use the monitor during MRI scanningor in a MRI environment as it may result in
physical harm.
The operator should verify that the synchronous input equipmentisapplicable to this monitor
and the input signals are valid.
In normal use, the operator shouldnot touch the signal I/O ports, other live equipment and the
patientsimultaneously. This action may result in injury to thepatient.
The installation and replacement of fuse should be performed by service technician trained and
authorized by our company.
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 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, verify that the supply voltage and frequency conform to the
requirements specified on the monitor nameplate or in this manual.
At the end of the monitor service life, the monitor and its accessories must be disposed of in
accordance with the local laws and hospital’s regulations.
Dry the equipment immediately in case of rain or water spray.
Check the cables, paddle handles and functional accessories periodically for possible defects.
Note
Place the monitor at a position where observation, operation and maintenance are convenient
and not obstructed.
This manual is based on the maximum configuration; therefore, some contents may not be
applicable to your monitor.
Keep this manual available for ease of use and timely reference.
The monitor is not intended for home use.
The monitor can only be used for one patient at a time.
The service life of the monitor is 5 years.
1.2 Contraindications
Unclear
1-3
Safety
1.3 Symbols
1-4
Chapter 2 Overview
The defibrillator/monitor is applicable to manual defibrillation, AED defibrillation, pace-making and vital
sign monitoring on patients.
The expected operator position is about one meter around the monitor in normal use.
2.1.2 Components
The defibrillator/monitor is composed of main unit, battery, paddles (external defibrillation paddles, internal
defibrillation paddles), pads and other functional accessories.
2-1
Overview
2.2 MonitorViews
Handle
Area 1
Area 4
Area 2 Area 3
2-2
Overview
2.2.1.1 Area 1
3 4
1 Alarm lamps
2 Display
3 AC power Indicator on: this monitor is connected to AC power
indicator supply.
Indicator off: this monitor is disconnected from AC
power supply.
Battery indicator Indicator solid on: battery is being charged.
Indicator blinks: battery is used to supply power to the
monitor.
Indicator off: battery is fully charged, is not installed
or malfunctions.
Service indicator Indicator blinks:The auto test or user test fails
Off: The unit operates properly
4 Soft buttons: one-to-one correspondence to the soft button labels on display screen. The
buttons have different functions under different operating mode.
2-3
Overview
2.2.1.2 Area 2
1
5
1 Record key
2 Speaker: Used to sound an alarm and a language prompt.
3 Record latch lock
4 Paper exit
Red: Recorder error, for example, No paper, Recorder door open,
Error indicator
etc.
5 White: Recorder is powered on
Power indicator Off: An error occurred to the recorder or the recorder is not
installed correctly
2.2.1.3 Area 3
1 8
7
2 6
3 5
2-4
Overview
5 Lead Select Press to select lead for the first ECG waveform.
2.2.1.4 Area 4
1 Mode Selector: Rotate to switch operating mode, including AED, Pacer, Monitor,Manual
defibrillation and OFF mode, and select energy level in Manual defibrillation mode.The
monitor will shut down when in OFF position for about3s.
2 Energy Select button: Press ―-‖ and ―+‖ to decrease and increase energy level respectively
in manual defibrillation mode.
3 Charge button: Press to charge the defibrillator.
4 Shock button: Press to deliverdefibrillate orenergy to patients
2-5
Overview
2-6
Overview
Hook
Battery
Sensor connectors
TEMP1 connector
TEMP2 connector
2-7
Overview
Hook
USB connector
Battery1
Net connector
Multi-function
connector
Battery 2
VGA connector
Equipotential
Power connector
connector
1. Equipotential connector: When the monitor is used together with another equipment, use a wire to
connect the equipotential terminals of the monitor with that equipment. This eliminates the ground
potential difference, thus ensuring the safety.
2. USB connector: supportingprinter and other USB equipment (plug and play).
3. Network connector: connectingto the central monitoring system or other equipment by a network cable.
4. Multi-function connector:
Warning
Only the approved analog or digital equipment in accordance with the specified IEC standards
(like IEC 60950 safety standards for Information Technology Equipment, IEC 60601-1 safety
standards for medical electrical equipment, etc.) are allowed to be connected to the monitor. All
2-8
Overview
configurations should comply with the valid version of the standard IEC 60601-1.Personnel who
connects external equipment to the signal I/O ports of the monitor should verify that medical
system complies with IEC 60601-1 requirements, before configuring the medical system and
connecting the external equipment.
In normal use, the operator shouldnot touch the signal I/O ports, other live equipmentand the
patientsimultaneously.This action may result in injury to thepatient.
If more than one external equipment is connected to the monitor at one time through the patient
cable connector, network connector or other signal ports, the total leakage current should be
inaccordance with the requirementpecified in IEC 60601-1.
Shock indicator
Shock key Shock key
Energy select key Charge key
Apical electrode
Sternal electrode Electrode paddle handle paddle
paddle
This monitor uses a backlight LCD color screen which can simultaneously display:
Physiological parameters,
Waveforms,
Alarm message,
Time,
Battery level,
2-9
Overview
2 3 4 5 6
8 12 9
7
11
7
1
10 9 8
1
1. Patient information area: Display the patient type (adult, pediatric and neonate),pacemaker status,
andname. Select the patient info to enter the [Patient Manage] menu.
For patients with 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; when [Pace]
(Pacemaker) is disabled, icon is shown at the upper right corner of this area.
2. Time: Shows the current configured time of the monitor. You can enter the [Main Menu] → [Maintain] →
Enter Password → [Time Setup] menu to reset the system clock according to your local time zone.
3. Prompt icons:
Display the current technical alarm (for example: ECG LEAD OFF). When there are multiple technical
alarms, alarm messages scroll in a cycle. Selectthetechnical alarm message area to enter the [View
2-10
Overview
Display the current physiological alarm (for example: ***RR TOO HIGH). When there are multiple
physiological alarms, alarm messages scrollin a cycle. Selectthephysiological alarm message area to enter
6. Battery status icon: Indicate the status of two batteries. Refer to Battery for detail.
7. Parameter Area
Display the measured value and the set alarm limit of each physiological parameter.
The parameter is displayed asthe same color with the corresponding waveform.
For details on the layout of this parameter area, see Section 5.5.6 Screen Setup.
These three labels are one-to-one corresponding to the three soft buttons below them. They will vary with
different operating modes and display screens. Blank labelindicates the corresponding soft button is
invalid.
9. StatusMessage Area
Display the energy selected, shock times and relative prompt message.
Display the measurement waveforms with the waveform name at the left top corner.
The defibrillator/monitor is applicable to pre-hospital and in-hospital use and must only be used by qualified
medical personnel who have receivedenough operation training, basic life support training and advance
cardiac life support training.
Themonitorsupports four operating modes, including manual defibrillation mode, monitor mode, pacer mode
and AED mode.
2-11
Overview
In manual defibrillationmode, operators analyze patient’s cardiacrhythm and operatefollowing the steps below
according to needs:
1. Select manual defibrillation mode and adjust energy level if necessary;
2. Charge the defibrillator;
3. Shock.
Synchronized cardioversionis also provided in manual defibrillation mode.
Manual defibrillation is applicable to patients suffering from ventricular fibrillation and ventricular
tachycardia and without respiration and pulse; synchronized cardioversion is used to stop atrial fibrillation.
Contraindications
Do not conduct manual defibrillation on patients of any kind below:
With response
With autonomous respiration
Can touch the pulse
2.4.1.1 MonitorMode
In monitormode, the defibrillator/monitor is applicable to adult, pediatric and neonate bedside monitoring and
can be used to monitor, display, store, review and transfer multiple physiological parameters including ECG,
RESP, TEMP, SpO2, NIBP, IBP and CO2.
Pacer mode provides noninvasive pacing therapy. Noninvasive pacing is used to conduct therapy for
bradycardiapatients.
Contraindications
Noninvasive pacing cannot be used for ventricular fibrillation therapy. Noninvasive pacing should be used
with cause in case of hypothermia.
In AED mode, the defibrillator/monitor analyzes patient’s cardiac rhythm automatically and gives ―Shock
Advised‖ or ―No Shock Advised‖ prompts. What’s more, the defibrillator/monitor can guide operators to
conduct defibrillation through voice prompt and display prompt message on the screen as well.
AED is applicable to sudden cardiac arrest patients of the following kinds:
Withoutresponse
Without respiration or Not breathing properly
2-12
Overview
2-13
Chapter 3 Installation
Warning
Thedefibrillator/monitor must be installed by the personnel specified by our company.
With copyright reserved, any person shall not falsify, photocopy or exchange the software in any
manner whatsoever without prior written permission of our company.
When the defibrillator/monitor is connected with other electrical equipment as a combination
with specific function, if users could not confirm the combination has no danger (for example,
the electric shock hazard caused by the accumulated leakage current) from the specifications of
each equipment, please contact the specialist of our company or the hospital to ensure the
combination is safe.
Only the analog or digital equipments compliant with the specified IEC standards (like IEC
60950 standardfor data processing equipment, IEC 60601-1 standardfor medical equipment,
etc.) are allowed to be connected to the defibrillator/monitor. The configuration of these
equipment should comply with the valid version of IEC 60601-1 standard. The person who
connects external equipment to the signal I/O interface should configure the medical system and
ensure the medical system complies with IEC 60601-1 standard. If you have any question, please
contact our company.
Carefully take the monitor and its accessories out of the packing box and check according to the following
aspects.
1. Check whether all accessories are provided according to the Packing List.
Warning
This equipment may suffer from microbial contamination during transport, storage or use.
Please check whether the packaging is intact, especially for the disposable accessories, and do
not use those with any damage.
The disposal of packaging materials shall comply with the local laws and regulations or the
waste disposal rules and regulations of the hospital. Keep the packaging material out of the
reach of children.
3-1
Installation
Before powering on the monitor, verify that the supply voltage and frequency conform to the requirements
specified on the monitor nameplate or in this manual. The steps of connecting the AC power cord:
1. Using the power cord that came with the instrument, connect one end of the power cord to the power
connector on the instrument and the other end to a grounded electrical outlet.
2. Check if the AC indicator is lit. The indicator lights up when the AC power is turned on.
Note
Connect the power cord to specifichospital outlet.
When a battery is provided, the battery must be charged after transportation or storage. If the
battery is low, the monitor may fail to workwithout connecting an AC power supply. Once the
monitor is connected to an AC power outlet, the battery will be charged whether the monitor is
switched on or not.
Connect the equipotential conductor when necessary. Please refer to the content about equipotential grounding
in the―Patient Safety‖.
3.3 Start-up
1. Before power on, please check whether there is mechanical damage on the defibrillator/monitor and
whether the external cables and accessories are connected correctly.
2. Insert the power cord into AC power supply socket. If battery is used to supply power, make sure that
there is adequate battery power.
3. Rotate the mode selector to the desired operating mode. First the left alarm lampturns red and right turns
cyan, and then left turns yellow and right turns blue.
4. Startup picture disappears and the defibrillator/monitor enters the selected operating mode.
Warning
If any evidence of failure or any error message is found, donot use this monitor. Contact a
service technician of our company or a biomedical engineer in your hospital.
Note
The system soundsan alarm when a major error is detected in the self-test.
Check all monitoring functions to ensure that the monitor can operate normally.
The battery must be charged after each use to ensure that sufficient battery power is available.
To extend the service life of the monitor, after shut-down, wait for at least 1 minute before
restarting the monitor.
3-2
Installation
Confirm what kind of monitoring or treatment is needed and connect the required sensor or patient cable to
the monitor and the patient's monitoring site. Please refer to the relevant sections for the correct connection
method and related requirements for various sensors and patient cables.
3-3
Chapter 4 Patient Safety
The monitor is designed in accordance with international safety standards for medical electrical equipment. It
is provided with defibrillation-proof and electrosurgical protection with floating groundinput.
Before powering on the monitor, verify that the supply voltage and frequency conform to the requirements
specified on the monitor nameplate or in this manual.
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.
To protect both the patient and the operator, the housing of the monitor must be grounded. The monitor is
equipped with a detachable 3-wire power cord, which shall be inserted into a grounded power outlet to ensure
that monitor is grounded. If grounded power outlet is not available, contact the maintenance department in
your hospital.
Warning
It is NOT recommended to connect the 3-wire power cord to a 2-wire power outlet.
Connect the ground wire to the equipotential connector of the monitor. If you have doubt about whether
equipment used may causeany electrical risks, such as risk caused by accumulation of leakage current, consult
an expert in this field to ensure the safety of all equipment.
The monitor must be connected to a power outletwith protective grounding. For cardiac or cerebral
examination, the monitor must be connected to a standaloneequipotential grounding system. Connect one end
of the equipotential conductor (potential equalization conductor) to the equipotential connector on the rear
4-1
Patient Safety
panel of the monitor and the other end to a connector of the equipotential grounding system. In the event the
protective grounding system is damaged, the equipotential grounding system can provide protection to the
patient and operator.
Cardiac (or cerebral) examination can only be performed in a room installed with a protective grounding
system. Before each use, ensure the monitor is in a normal operating status. Cables connecting the patient to
the monitor must not be contaminatedby electrolyte.
Warning
If the protective grounding system is not stable, use the built-in battery to supply power to the
monitor.
Note
If the use of the equipment is affected by the equipotential grounding, 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 is 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.
In pacer, monitor and manual defibrillation mode, press key on the front panel to access [Main Menu] and
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 select ECG waveformto open the [ECG Wave] window.
In the parameter area: Select a parameter and the corresponding setup window will display. For example,
you canselect the ECG parameter areato open the [ECG Setup] window.
In the [Measu. Setup] menu: Enter [Main Menu] → [Measu. Setup]) toopen the [Measu. Setup]
Enter [User Maintain] → [Time Setup]. Set the system time 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 screen language that you want.
Enter [User Maintain] → [Unit Setup]. Set 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
2) Select the appropriate brightness in X~100. 100 indicates the brightest, and X indicates the darkest (X
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.
Area 1:Waveform area: You can choose to display the parameters and their waveforms (if one exists).The first
row of this area always shows the first ECG waveform and parameter.Waveformsare displayed on the left and
parameters on the right. The waveform and its corresponding parameter are shown on the same line.
Area 2: you can choose to display the parameters. But if a particular row in the area 3 has no parameter, the
corresponding row in area 2 will display parameters and waveforms at the same time.
Area 3: Parameters without waveform: Only data are displayed for parameters in this area.
5-3
Basic Operations
which depends on the setting of the Minimum Alarm Volume) and 10 (the loudest volume). Refer to the
2) Select [QRS Vol.] (QRS Volume): Select the appropriate volume within 0~10;
To freeze all waveforms on the screen, click the freeze quick 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 rotary knob to select the forward or backward key and thenrotate 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,
5-4
Basic Operations
Event setup involves saving waveforms for manually triggered events. During patient monitoring,
theoccurrence of some events may have certain impacts on the patient, resulting in changes in some
waveforms or parameters. You can select manually triggered events in [Manual Trigger] settings. When an
event is triggered, the monitor marks it and saves the corresponding waveforms and value. You can review the
event later to analyze its impacts. To configure:
1) Enter [Main Menu] → [Event Setup]→ [Event Marker Setup].
2) Choose 3 waveforms from the available options as [EventSave Waves] and mark event: [EVENT A]:
Default general event, which cannot be set by the user. [EVENT B/C/D/E/F/H]: the following events can
4) After the event setting is completed, select the event tag button on the panel to enter [Event Marker
You can turn on/offthe 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 for that module.
1) Enter [User Maintain] → [Module Setup].
Youcan set the password for entering the [User Maintenance] according to yourown needs.
1) Enter [User Maintain] → [Set User PassWord].
5-5
Basic Operations
High contrast display is helpful for operators to view the contents displayed on the screen in the environment
with strong light.
In pacer, monitor and manual defibrillation mode, enter [Main Menu], select [High Contrast] and enter high
contrast display with [High Contrast] turning to [Normal]simultaneously.Select [Normal] to exit high contrast
display.
In AED mode, press [High Contrast] soft button to enter high contrast display and press [Normal] soft button
to exit the high contrast display.
The high-contrast display is turned on in one mode of operation, and the high-contrast display is maintained
when switching to other clinical modes, but the system no longer saves the settings after shutdown.
5.5.13 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 monitor performance and assist in training course. In actual clinical
use, it is NOT recommendedto use the demo mode, because the users/operators may mistake
the demo data for waveforms and patient parameterswhich can put patient safety at risk.
5-6
Chapter 6 Patient Management
You can enter the [Patient Manage] menu in one of two ways:
a) Enter [Main Menu] and select [Patient Manage];
b) Click in the patient info area on the upper menu bar.
6.1 Admit
When a patient is connected to the monitor, the monitor displays and saves 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?] is 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?] is shown.
3) Enter patient info in the [Patient Info] menu. Pay attention that [Pat Type] (Patient Type) and [Pace]
(Pacemaker) are set correctly. You can use keyboard 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 compute 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 is shown above the ECG waveform, and is
shown at the upper right corner of the message prompt area. When [Pace] is set to [OFF], no prompt
Warning
Whether a patient is admitted or not, 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 before monitoring.
When the patient type is changed, the system loads the factorydefault configuration.
6-1
Patient Management
Verifythealarm limits before patient monitoring to ensure that these alarmlimits suit your
patient. When the patient type is not changed, the current configuration is not changed.
For the patient without pacemaker, [Pace] must 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 admittedwith 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
information. However,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?
Admit new patient?]is 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?] is shown.
3) Enter the [Patient Info] window, set [Pat Type] and [Pace], and then close the window.
6.3 Discharge
[Yes]: Discharge the current patient. The original patient data will bearchived automatically if the
monitor is mounted with a SD card. You can review the archived patient data in [Document
Manage].
Warning
After the patient is discharged, [Pace] will be automatically set to off.
6-2
Patient Management
You can inquire, review, delete and export archived patient files in [Document Manage]. However, patient
data cannot be archived if the monitor is not installedwith a SD card.
[Query]: Enter the patient name in the field at the lower left corner of the [Document 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], [Wave Review]and [Patient
Event Review].
[Delete]: Delete the selected patient file.
[Export]: Export the selected patient file to a USB flash drive or PC.
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
5) Ifyou check the box at the lower left corner, all patient files are 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
6-3
Patient Management
Warning
Patient alarm messages, physiological and technical alarms are saved in the patient file.
In the event of a power interruption, alarm events arestillsaved in the patient file.
When exporting data to a USB drive, do not remove the USB drive until the export process is
completed in order to prevent data corruption.
When exporting data to an FTP server, do not disconnect the network cable until the export is
completed, in order to prevent data corruption.
Note
When the monitor is shut down, the data in the monitoring period before the shutdown is
saved automatically. Upon start-up of the monitor, the system automatically creates 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
anunownedtemporary case (Temp Case), whichcan be automatically deleted. Also, the monitor can
automatically delete old cases when the SD card is full.
To automatically delete the unownedcase and old case, do the followings:
1) Enter [User Maintain] → [Save Tactics];
2) Select [Auto Del Temp Case] and [Del old case] respectively, and switch them between [ON] or[OFF].
6-4
Chapter 7 Configuration Management
7.1 Department
The department in which the monitor is used. When Department is modified, all user configuration files of the
previous department are deleted. Each department has 3 factory default configurations, i.e. ADU (Adult), PED
(Pediatric), NEO (Neonatal). At most 3 user-defined configurations can be saved to the currentdepartment
configuration directory. Before managing the configuration, ensure that the correct department is selected.
Department options: General (General Monitoring)
OR (Operation Room/Anesthesia Monitoring)
Note
Upon start-up or before admitting 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.
Make sure the configuration you select is appropriate for the patient being monitored.
Use of different configurations on the monitor in the same department (e.g., ICU or Cardiac
OR) may put patient safety at risk.
The monitor automatically loads the corresponding default factory configuration when you
switch to another department or change the patient type.
The monitor can memorize system configuration.
7-1
Configuration Management
[Internal Defib Energy]:set the default energy for internal manual defibrillation. The available energy
level includes 2J,5J, 10J, 20J, 30J and 50J.
[Auto Disarm Time]:set the time to energy auto disarm, including 30s, 60s, 90s and 120s. If the shock
button is not pressed for discharge within the set time, the defibrillation monitor will automatically
release the energy.
[Sync Keep]: switch [ON] or[OFF]. [ON] means the monitor is still in synchronized cardioversion mode
after a synchronized shock. [OFF] means the monitor will auto exit synchronized cardioversion mode
after a synchronized shock.
[Remote Sync Input]: switch [ON] or[OFF] to activate or deactivate the remote synchronized
cardioversion function respectively.
[Battery Charge Vol]:adjust the battery charge tone volume. Available volume level includes [High],
[Med]and[Low];
[Contact Imped Prompt]: toggle between[ON] and[OFF].[ON] means there will be contact impedance
indicator displayed in manual defibrillation mode.
7-2
Configuration Management
[Audio Recording]: switch [ON] or [OFF] to activate or deactivate the audio recording function in AED
mode respectively.
[Report Format]: select the report format of 12-lead ECG, including 3×4 and 4×3.
You can save the current configuration as a user configurationafter entering a configuration name. The
configuration name can consist of alphanumeric characters or underscore (_), but cannot be empty. If the
name you have entered is already used by another configuration, the message [Overwrite configwith same
name] will display on the screen. The monitor can save up to 3 user configurations.
Delete user configurations currently saved in the monitor. In this menu, all user configurations saved under
the current department are listed, with patient type in brackets added after each configuration name. For
example, John (ADU) indicates that the configuration ―John‖ is saved when the patient type is ADU.
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 name. After
you load configurations, itreplaces the current configurations and become effective.
7-3
Configuration Management
You can import configurations from a USB flash drive if there are less than 6 configurations for the current
department.
You can set the configuration adopted by the monitor when it restarts.
But after the monitor powers off, the configurations are set according to the followingrule:If restarted within
120s after powering off, the monitor automatically uses the latest configurations; if restarted 120s later after
powering off, the monitor uses the configurations according to [Startup Configuration].
[User Test Prompt]: switch [ON] or [OFF]. [ON] means the monitor will give a prompt when the user
test is overdue.
[Auto Test Time]:set the time when the monitor conduct daily auto test. Available test time includes 0:00,
1:00, 2:00, 3:00, 4:00 and5:00.
7-4
Configuration Management
In this menu, users can set the network bed number, IP address, subnet mask, server IP,Server Port,Gateway
and MAC address.
When the connection is successful, the message prompt area at the bottom of the screen prompts [CMS
Connected]. See " Connection to Central Monitoring System " for details.
7-5
Chapter 8 Monitor Screen
This monitor provides two user screens in monitor mode: standard screen and 12-lead screen. User can get
different screen messages from different screens.
8.1 Standard
Standard screen can display waveforms of up to 4 channels with separate parameter display area based on the
maximum configuration. The waveform on each channel is not fixedand you can change the position of each
waveform as needed.
Switch to monitor modeand open the standard screen as shown below:
On standard screen, the three soft button labels are [Freeze], [Review] and [Alarm Reset].
12-lead screen can display ECG waveforms of 12 leads, including I, II, III, AVR, AVL, AVF, V1, V2, V3, V4,
V5 and V6, applicable to comprehensive observation of ECG waveforms when the lead type is 12-lead. Under
this interface, the monitor only provides diagnostic filtering mode.
In monitor mode, press the (12 Lead) key on the front panel to enter the 12-lead screen, as shown below:
8-1
Monitor Screen
Under the 12-lead screen, ECG data can be collected and analyzed, and ECG diagnostic reports can be output.
The patient information can be modified in the 12-lead screen. Select the [Patient Info] softkey to enter the
[Patient Info] menu for modification.
Under the 12-lead ECG monitoring screen, select the [Collect] softkey to collect the patient's ECG waveform.
At this time, the screen pops up the message ―Acquiring Ecg......, Keep Ecg electrodes connected properly‖.
Collect the ECG signal for 10s, then the screen pops up " Analying Ecg......, please keep the lead connection
normal". After about 10 seconds of analysis, a diagnostic report is output. Keep the patient still during the
collection of the signal.
All diagnostic reports are automatically saved in the [12-lead Report Review] window. See the Section 12-
lead Report Review for details.
To exit the 12-lead interface, press the button on the lower shell again, select the [Exit] softkey or set the
[Lead Type] to [3 Leads] or [5 Leads].
Warning
Keep patient still while acquiring 12-lead ECG data, or the accuracy of ECG data will be
affected.
If the monitor is put in a mobile vehicle, please stop the vehicle when acquiring12-lead ECG
data.
Note
[Lead Select] on the panel is not selectable when the 12-lead screen is displayed.
When gathering 12-lead ECG signal, only [Alarm Pause], [12-Lead] and record button on the
panel can be activated.
When the device is powered by AC, [Noth Filter] should be set as [on] to avoid interference on
8-2
Monitor Screen
2) Wave style.
1) In the [Standard]screen, 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],
8-3
Monitor Screen
8-4
Chapter 9 Alarm
When a patient under monitoring or therapyhas abnormal vital signs, or when failure occurs in the monitor,
the system sounds audible and visual alarm to remind the user.
When there are multiple alarms and prompt messages, messages scroll in a cycle.
Warning
Use of different configuration on different monitors in one area (e.g., ICU or OR) may
affectpatient’s safety
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 is triggered when the monitordoes not operate 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 shows 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
Alarm
When an alarm is generated, the monitor uses the following alarm modes to alert the user:
Alarm Lamp
Audible Alarm
Alarm Message
Flashing Parameter
Alarm indicators at the upper left corner of the monitor indicate alarm levels with different light colors and
flashing frequencies.
Physiological Alarm:
High-level: Red (Left light), flashing.
Medium-level: Yellow (Left light), flashing.
Low-level: Yellow (Left light), consistentlyon.
Technical Alarm:
High-level: Red (Left light), flashing.
Medium-level: Yellow (Left light), flashing.
Low-level: Cyan (Right light), consistentlyon.
9-2
Alarm
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 (Center Monitoring System) are provided with audible
alarm function.
When this monitor is connected to the CMS, you can use the same high and low alarm limits for
the monitor and CMS. If you enable alarm delay on this monitor, it will not display when CMS
indicates an alarm.
When multiple alarms of different levels are generated simultaneously, the monitor will activate
the warning sound and light for the highestlevel alarm.
Certain physiological alarms, such as asystole and respiratory arrest, are exclusive. The sound
and light expression of this type of alarm is the same as that of the high-level alarm, but the
alarm information is displayed in an exclusive manner, that is, when the general physiological
alarm and the exclusive physiological alarm occur simultaneously, only the text alarm
information of the exclusive physiological alarm is displayed.
Alarm messages are shown in the physiological alarm area or technical alarm area on the screen.
Different background colors are used to indicate the alarm levels:
High-level: Red
Medium-level: Yellow
Low-level: Yellow (Physiological Alarm)/ Cyan (Technical Alarm)
Different marks are added in front of alarm messages to indicate the alarm levels:
High-level: ***
Medium-level: **
Low-level: *
When a parameter valueis outsidethe alarm limit, the parameter and its high/low limits flashevery second,
indicating the measured result is beyond the high or low limit.
9-3
Alarm
Do not set the minimum alarm volume too low; otherwise you cannot hear the alarm sound. This may put the
patient safety into danger. Follow the steps below to set 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 be hard to be heard. Set the
minimum alarm volume should be higher than environmental noise.
The pressure level of alarm sound generated by this monitor is 45-85db.
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 is shown in the message prompt area of the screen,
level alarm respectivelybyentering the value in[High Alarm] and [Medium Alarm]based on the setting
in[AlmVol].
Warning
When the alarm volume is set to 0, the monitor cannot sound an alarmeven if a new alarm is
generated. Therefore, you should consider this when setting the alarm volume to0.
Do not relyonly the audible alarm. Otherwise, patient safety may be at risk if the alarm volume
is low. Pay close attention to the patient’s actual clinical conditions.
Maximum alarm volume is no more than 10.
9-4
Alarm
When the alarm volume is set to 0, or the cardiopulmonary bypass mode is selected, the monitor provides
periodic prompt tone to remind that there is an activated alarm in the system. Follow the steps below to set
alarm reminders.
1) Enter [User Maintain] → [Alarm Setup].
Warning
When setting alarm limits to extreme values, the alarm system may be useless.
When setting high and low alarm limits, make sure the patient type is correct (ADU, PED or
NEO).
If you have set the high and low alarm limits manually, the monitor will display these high and
low alarm limits instead of the default alarm limits of the system.
If power-off accidentally occurs, the equipment retain the latest settingfor 120s.After120s, the
monitor sets the configurations according to [Startup Configuration] whenrestarts.
Note
When applyingfactory default configurations, alarm limits of the parameters will also change.
See ―Default Configurations‖ for details.
9-5
Alarm
automatically recognizes which alarm range the measured parameter value belongs to, and then will generate
an alarm of the corresponding level.
For parameters of general alarms, you need to set the alarm level and only set the alarm limits corresponding
to the alarm level selected. When the measured parameter value is beyond the normal range, the monitor will
generate an alarm according to the alarm level selected. Intelligent alarm gradation is available on ECG, NIBP,
PR, AwRR and SpO2 (excluding NellcorSpO2) and not other parameter.
For parameters subject to intelligent alarm gradation, the procedures to setalarm limit are the same. For
example:
1) Select the ECG parameter area to enter the setup menu → [Alarm Limit Setup].
2) Set the appropriate high and low limits for the parameter.
For parameters subject to general alarms, the procedures to set alarm limit are the same. For example:
1) Select the RESP parameter area toenter the setup menu → [Alarm Limit Setup].
2) Select the check box at the lower left corner of the setup window of the corresponding parameter to
toggle the alarm level.
3) Set the appropriate high and low limits for the parameter under the current level.
The monitor can automatically set the 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 inappropriate, you need
to manually set the alarm limits.
Follow the stepsto set auto alarm limit:
Enter [User Maintain] →[Alarm Setup] → [Auto Alarm Limit].
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
immediately. If [5s]/[10s]/[15s]/[20s] alarm delay is selected, the monitor gives alarm when the measured
parameter value has been consistantlybeyond the alarm limit for 5s, 10s, 15s, 20s, respectively.
NOTE: Alarm delay cannot be applied to ECG and IBP.
9-6
Alarm
If the monitor is equipped with a recorder, the monitorrecorder will print the parameter waveform and value,
if all the following conditions are satisfied: a parametervalue is abnormal,the alarm switch is turned on, and
[Alm Record] is set to on.
1) Enter [Main Menu] → [Alarm Setup] → [Alarm RecordSetup].
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].
You can switch the alarm record icon to [OFF] to deactivate alarm record of one specificparameter; to
deactivate all parameter alarm records, select [All Rec. Off].
To quickly enter the alarm pause status,press the key on the control panel.When alarmis paused, the
followings occur:
Alarm sound, alarm light and alarm message are disabled for physiological alarms, and no physiological
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 exit the alarm pause status and automatically
After the alarm pause timeexpires, the monitor cancels alarm pause automatically; you can press the key
to cancel alarm pause.
To set alarm pause time, follow:
1) Enter [User Maintain] → [Alarm Setup] → [Alm Pause Time].
9-7
Alarm
2) Set the appropriate pause time: [1min], [2min], [3min], [5min], [10min], [15min].
Only physiological alarmscan beturned off. When alarm is turned off, the sign is shown on the left side
below the corresponding parameter in the parameter area:
For physiological alarms, sound, light and text prompts are disabled, and no new physiological alarms
will be triggered.
2) Select [AllAlm Off] to disable alarms against all parameters. If the alarm ON/OFF icon of a
parameter is switched to [OFF], alarms for that parameter are disabled.
To turn on the alarms of all parameters, select [All Alm On]; to turn on the alarm of one parameter, switch the
alarm ON/OFF icon of that parameter to [ON].
Warning
If the alarm is turned off, the monitor cannot provide alarm indicationswhen the parameter is
inan alarm condition. Therefore, you should be carefulturningthe alarm off.
The alarm system isdisabledby default when entering the manual defibrillation mode or AED mode. The
monitor provides periodic prompt tone to remind that the alarm system isdisabled.
After entering the synchronous defibrillation mode, monitoring mode or pacing mode, the alarm system is
automatically turned off.
You can reset the current alarm with the [Alarm Reset] soft key:
Cease the audio alarm indication of all physiological alarms and technical alarms.
If a new alarm occurs, resetting will be interrupted, and the alarm indicationsare generated immediately.
For the technical alarms of leadoff and sensor off, background color iscleared and alarm light is switched
off.Other physiological and technical alarmsbackground color and alarm light cannot be cleared.
Thesign√ appears in front of the alarm message, indicating that the alarm is acknowledged.
9-8
Alarm
After the monitor is turned on, the alarm indicator will light up in cyan and red, cyan and yellow, and the light
alarm signal will start working. If the alarm system does not work properly, please contact our engineers in
time.
The system can be further tested through SpO2 or NIBP parameter. For example:
1) Connect the SpO2 cable to the monitor.
4) When the measured value is beyond the high/low alarm limit, confirm whether the changes in sound,
light , message and parameter flashing on the monitor conform to the descriptions in the section “Alarm
Lamp”, “Audible Alarm”, “Alarm Message”, and “Alarm Parameter Flashing” 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 [SpO2Finger 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 (The pressure parameter 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, 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 monitor is suitable for three-lead, five-lead or twelve-lead monitoring. It can also be used for ECG
monitoring using external defibrillation electrode paddles and multi-functional electrode pads. Different
waveforms are displayed according to ECG cables of different leads.
Warning
During defibrillation, do not contact the patient, table or equipment.
Before monitoring, ensure that ECG cable is properly connected. Ifthe ECG cable is
disconnected from the connector, the monitor displays the prompt message ―ECG Lead Off‖
and sounds an alarm.
Use only ECG electrodes and cables specified by our company.
The ECG cable with defibrillation-proof protection should be used when conducting
defibrillation.
Different metal materials cannot be used for the electrodes.
Do not use if the electrode package or electrode has signs of damage.
Please do not mix electrodes of different types and brands. Mixing the electrodes may result in
a large baseline drift or a longer recovery time after defibrillation.
When connecting the electrodes or patient cable, ensure that the patient does not come into
contact with any other conductive parts or the ground. Confirm that all ECG electrodes
(including neutral electrode) are attached the patient’s body.
Check whether the ECG electrode patch or paddlehasirritationto the skin every day. If there is
any sign of allergy, replace the electrode or paddleor change its position.
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
monitor, causing failure to monitor an asystole.
Equipments such as defibrillator and remote measurement unit can generate a filtered ECG
signal. When this signal is used as the input signal for bedside monitor, it is filtered again. If
11-1
ECG Monitoring
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 asystole.
This failure degrades the performance of the equipment when it is used for monitoring patients
with pacemakers.
During defibrillation, the ECG cable connected to the patient may get damaged.
Whenreusingsuch cables, you should check that function prperly.
If electrodes are used correctly and attached according to the manufacturer’s instructions, the
ECG parameter on monitor screen recovers within 5safter defibrillation. For electrosurgery or
defibrillation, the measurement accuracy may be reduced temporarily, but this accuracy will
not affect the safety of the patient or the equipment.
When the monitor is connected to an electrosurgical unit (ESU), in order to protect the patient
from injury caused by leakage current, do not putthe sensors and cables of the equipmentin
contact with the ESU.
Do not expose the monitor to X-ray and high-intensity magnetic fields.
Note
Interference from ungrounded equipments near the patient, as well asESU interference may
result in a waveform problem. If the monitor 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 equipment in a place near the monitor ifECG/RESP is being measured.
If the ECG electrode is correctly placed but the ECG waveform is still inaccurate, replace the
leads.
To protect the environment, recycle and dispose used electrode patches appropriately.
Dot not to use external paddles to conduct ECG monitoring.
If the source of the selected ECG signal is not available, the ECG waveform will be shown as a
dotted line.
3 4 5 6 7 8 9
11-2
ECG Monitoring
Attention
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 soapwater to thoroughly clean the skin. (Do not use diethyl ether or pure alcohol because these
5) Use ECG preparation paper and gently rub the skin, so as to remove dead skin and improve the
The table below lists the names of leads in European and American standards. (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):
11-3
ECG Monitoring
See 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
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:
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
11-4
ECG Monitoring
Lewis
LA Black (U.S.A.)
L Yellow (EU)
RA White (U.S.A.)
R Red (EU)
LL Red (U.S.A.)
F Green (EU)
Refer to American and European standards for placing electrodes of 5-lead unit:
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 the following figure.
V Brown (U.S.A.)
C White (EU)
For 5-lead configuration, place the chest (V) lead electrode at one of the following positions:
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.
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ECG Monitoring
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
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.
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ECG Monitoring
Warning
When using an ESU, never place electrodes close to the ground plate of the ESU; otherwise
there is too much interference against the ECG signal.
When the monitor is connected to an electrosurgical unit (ESU), in order to protect the patient
from injury caused by leakage current, do not putthe sensors and cables of the equipmentin
contact with the ESU.
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 waveform 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 waveform
may become very small.
Note
When monitoringthe patient with 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 asystole.
When changing patient info or admiting/discharging a patient, check whether [Pace] is set
correctly.
When monitoring the patient with pacemaker, sometimes a part of pacemaker pulses cannot
be shielded. If pacemaker pulses are counted as QRS complex, it results in wrong heart rate
computation and failure to detect asystole or some arrhythmias. At this point, closelyobserve
the patient.
11-7
ECG Monitoring
11.4.3.1 Preparation
1. Place the RA pad or Sternum paddle on the patient’s upper right torso, lateral to the sternum and below
the clavicle, as shown below:
2. Place either the LL pad or Apex paddle lateral to the patient’s left nipple in the midaxillary line, with the
center of the electrode in the midaxillary line, as shown below:
Sternum
paddle
Apex paddle
Attention
When conducting ECG monitoring, the external paddles and pads can only be placed in the
anterior-lateral position.
11-8
ECG Monitoring
It is important to properly set the patient's pacing status before starting ECG monitoring. When [Pace] is set to
"On" and the pacing signal is detected, it is indicated by on the ECG waveform and symbol in the
patient information area; when the pacemaker is set to "Off", is only prompted in the patient information
Or;
Select [Main Menu] → [Patient Info] and set [Pace] to On or Off in the pop-up menu.
Or;
Select the ECG parameter area to enter the ECG setting menu, then select [Other Setup] and set [Pace] to
On or Off.
Warning
For the patient without pacemaker, [Pace] must 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 admitted 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.
ECG cables with different leads can be used to monitor different ECG waveforms. You can use the 3-lead, 5-
lead and 12-Lead ECG cables with the monitor.
When the 3-lead ECG cable is used, leads for monitoring include I, II and III. In the standard screen, ECG
wave of at most 1 lead is displayed.
When the 5-lead ECG cable is used, leads for monitoring include I, II, III, aVR, aVL, aVF and V. In the
standard screen, ECG wave of at most 2 leads are displayed.
When the 12-lead ECG cable is used, leads for monitoring include I, II, III, aVR, aVL, aVF,V1, V2, V3, V4,
V5, and V6. In the standard screen, ECG wave of at most 2 leads are displayed.
11-9
ECG Monitoring
When the lead type of the monitor is set to [Auto], the monitor automatically recognizes the leads for
monitoring.
Set the lead type for the ECG cable of the monitor:
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 ON, if the lead of the current channel comes off, the monitor automatically
switches to a channel where the lead is not off. When the lead that comes off is reconnected, the monitor
automatically switches back to the original channel.
Enable or disable this function:
1) Select the ECG parameter area to enter the setup menu → [Other Setup].
In the standard screen, when 3 Leads is selected as the lead type, only one ECG wave is displayed; when 5
Leads or 12 Leads is selected, two ECG waves are displayed.
1) Select the ECG wave to enter the [ECG Wave] menu → [Lead Name]
If the wave size is too big or too small, you can change the displaying size of wave by setting the gain.The
gainsetting will not affect ECG signal analysis of the monitor. With the wave and the 1mv scale provided on
the right side of the wave, you can obtain the optimal wave.
1) Select one ECG wave to enter the [ECG Wave] menu → [Gain].
Note
When the input signal is too strong, the wave crest may be cut off. In such case the user can
manually change the gain level of ECG wave according to the actual wave to avoid incomplete
wave display.
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ECG Monitoring
Filter Mode: Clearer or more accurate waves can be obtained through filtering. Four filter modes are available.
In the Diagnosis mode, ECG waves displayed are those without filtering.
In the monitor mode, the monitor filters artifacts that may result in false alarms.
In the Surgery modethat usually used in the OR, the monitorreduces artifacts and interference from the
ESU.
In the ST filter mode, the distorted reflection of the 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 obtains 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 can be displayed above the first ECG wave.
1) Select one ECG wave to enter the [ECG Wave] menu → [Filter Mode] → [Dia.], [Monitor], [Therapy] or
[ST].
Warning
The system providesraw signals only in the diagnosis mode. In the [Monitor] and [Therapy]
filter modes, the ECG wave distorts to different degrees. In this case, the system only provides
the basic ECG information, which greatly affects the result of ST segment analysis.
You are allowed to select the leads for HR computation and arrhythmia analysis. When setting the lead, make
sure that the following wave characteristics in this lead are satisfied:
a) Tall and narrow without notch.
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ECG Monitoring
The notch filter removes the line frequency interference. When the filter is not set todiagnosis mode, the
system turns on [Notch Filter] automatically. When the filter is setto diagnosismode, [Notch Filter] can be
turned on or off as needed.
1) Select the ECG parameter area to enter the setup menu → [Other Setup]
Attention
The setting of Notch Filter is not affected by the operation of restoring manufacturer
configuration or switching machine.
11-12
ECG Monitoring
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].
pacing signal is detected, the pacemaker pulse symbol is still displayed in the ECG wave.
In the condition of [Pacer Reject] beingoff, the display of pacing signal is not inhibited. When pacing
signal is detected, the pacemaker pulse symbol is displayed above the ECG wave.
When [Pace] is turned off, [Pacer Reject] cannot be operated.
11.5.11 HR Source
You can set theHR source todetermine whetherHR value or PRvalue is displayedin theECG parameter area.
The HR value color 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 heartbeat sound is provided.
[SpO2]: The ECG parameter area displays the pulse rate value from SpO2, andthe pulse sound is provided.
[ART], [PA], [UAP], [BAP], [FAP], [P1], [P2], [P3], [P4], [LV], [AO]: Specific pressure parameters
from IBPas thesource; display the pulse rate value from IBP (The pressure parameter selected as the
source depends on which pressure parameter is monitored by the monitor).
When [Mul. Lead Analysis] is turned on, the ECG setting of [Calculate Lead] become invalid. The module
intelligently selects the lead with good ECG wave for HR computation calculation.
1) Select the ECG parameter area to enter the setup menu→[Other Setup].
11.5.13 Cascade
Cascade is for user to observe the designated real-time ECG waveform for a long period of time. The Cascade
screenshows a cascade waveform of the same lead.In any working mode of the monitor, you can select ECG
waveform andturn on [Cascade]in the pop-up[ECGWave]. The number of cascade waveforms displayed
depends on the number of ECG waves present in the current screen. The operation over one of the ECG waves
also applies to other ECG waves.
11-13
ECG Monitoring
Note
In the screen of [12-Lead ECG], [cascade] is not selectable.
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 calculated data can
be displayed as the ST value. All available leads can be monitored continuously. For ST segment analysis, it
is unnecessary to display ECG waveform on the monitor. During ST segment analysis, a special filter should
be used to ensure the diagnosis quality. If you use an ECG filter mode other than [ST] to monitor ECG, the ST
segment of ECG wave may be slightly different in appearance from the ST segment of ST fragment for the
same waveform. To perform diagnostic assessment of ST segment, always switch to the [ST] filter mode.
In the ST segment analysis, the elevation or depression of ST segment on the designated lead can be measured.
Meaning of ST segment value: A positive number represents elevation; a negative number represents
depression.
ST segment measurement range: -2.0 ~ +2.0mV.
Presence of arrhythmia (e.g., atrial fibrillation/atrial flutter) that can cause irregular baseline.
Warning
This monitor provides information about changes in ST level, the clinical significance of should
be determined by a doctor.
1) Select the ECG parameter area to enter the Setup menu → [ST Analysis].
11-14
ECG Monitoring
Set the R wave peak point as the reference point for ST measurement point. The ST value for each beat
complex is the vertical difference between ISO point and ST measurement point. See the figure below:
R wave
J Difference= ST value
Note
If the HR value or ECG wave of the patient has changed obviously, you should adjust the
position of ISO and ST points. Abnormal QRS complex is not considered for ST segment
analysis.
Ensure that the position of ST measuring point is suitable for the patient.
3) Select [Adjust ST Point] to enter the [ST Analysis] window: three vertical lines are ISO, Jand ST,
respectively.
4) Select [ST Lead] to switch the measurement lead. Each time the shuttle is pressed, the name of the ST in
the window changes once, and an obvious ECG lead of the J point and the P wave is selected.
5) Select the points of [ISO (ms)] and [ST (ms)], press the button to adjust, and [J] to confirm the position
of each point.
The cursor position of ISO point is related to R wave peak equipotential. Use to locate the
ISO point in the middle of the flattest part 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 peak. 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
11-15
ECG Monitoring
This monitor saves 20 groups of ST analysis for reference and review. A ST segment shows a complete QRS
wave of all ST leads. The stored data is drawn in white; real-time data is drawn in green. Real-time data of ST
segment refreshes 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].
To save the current ST segment as reference, select [Save Ref.] (Save Reference).
To delete the current reference segment 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 set parameter alarm limit.The monitor allows you to set alarm limits for each lead. For operation
details, refer to the “Alarm” chapter.
Arrhythmia analysis is clinically used in patient ECG monitoring to detect HR changes and premature
ventricular contractions, and to save arrhythmia events and generate alarm messages. Arrhythmia analysis can
11-16
ECG Monitoring
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 make diagnosis and treatment on this basis.
The arrhythmia monitoring is setoff by default. You can enable this function as needed.
The arrhythmia monitoring canmeasure and classifyarrhythmia and abnormal heartbeat, as well as reminding,
the doctor to observe the patient’s heart rhythm and events that generate alarms.
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 [ArrAlarm Setup] to enter the [Arr Alarm Setup] window.In the [Arr Alarm Setup] window,you
can restore the settings, switch alarm on/off, setalarm level and switch record on/offfor the alarms of
[Asystole], [Vfib], [R ON T], [VT>2], [Couplet], [PVC], [Bigeminy], [Trigeminy], [SVT], [Brady]
(Bradycardia), [Pacer Not Capture], [Pacer Not Pacing], [Missed Beat], [IHB] (Irregular Heart Beat),
[Vtac] (Ventricular Tachycardia), [Tachy] (Tachycardia), [PVCs Too High], [Extreme Tachy], [Extreme
Brady], [Vent. Rhythm], [Heart Pause], [Vent. Brady], [Multif. PVCs Window], [Nonsus. Vtac], [Afib]
and [Pause/min]. Select [Restore] to restore equipmentto factory settingsfor the monitor.
NOTE: The alarm level and alarm on/off status of [Asystole], [Vfib], [Vtac], [Extreme Tachy], [Extreme
Brady] and [Vent. Brady] are in default, which cannot be changed by the user.
When using multi-functional electrode pads and electrode paddles for ECG monitoring, only five
arrhythmia alarms, Asystole, Vfib, Vtac, PNP, and PNC, are provided, and only Asys. Delay and
Attention
Asystole, Vfib, Vtac, Vent. Brady, Extreme Tachy, and Extreme Brady are exclusive high-level
alarms. For Asystole alarms, regardless of whether the arrhythmia analysis is turned on, an
alarm is triggered as long as the alarm condition is met.
11-17
ECG Monitoring
You can set the threshold of each arrhythmiabyselecting [ECG] in the parameter area, and then in the pop-up
[ECG Setup] menu, enter the [ARR Analysis] menu. The parameter ranges are shown as below:
No. Arrhythmia Type Setup Range Default Value Step Unit
1 PVCs 0-31 10 1 PCS
2 Tachycardia ADU: 60-160 ADU: 120 1 bpm
PED:60-180 NEO/PED: 160
NEO:60-200
3 Extreme ADU: 120-300 ADU: 160 1 bpm
Tachycardia PED:160-300 PED: 180
NEO:160-350 NEO: 200
4 Extreme 15-40 40 1 bpm
Bradycardia
5 Arrest Time 3-10 4 1 s
6 Ventricular 100-180 160 1 bpm
Tachycardia HR
7 Ventricular 3-15 12 1 PCS
Tachycardia PVC
8 Bradycardia HR 40-120 40 1 bpm
9 Vbrd PVCs 3-99 4 1 PCS
10 Multi. PVC 3-31 15 1 PCS
11 Heart Pause Time 1.5-3.5 2.5 0.5 s
12 Pause/min 1 -15 8 1 min
After setting Arrhythmia Threshold, when a value exceeds this threshold, an alarm will be triggered.
Attention
The setting of Asys. Delay is associated with ECG self-learning. When the HR is less than
30bpm, it is recommended to set the Asys. Delay to 10 seconds.
During ECG monitoring, when the ECG template of the patient changes significantly, you may need to start
an ARR Relearn. 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].
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ECG Monitoring
2) Select [ARR Relearn]; the system will give the prompt message [ARR Learning].
During ECG monitoring, if the patient’s ECG template changes significantly, you may need to manually start
an ECG Relearn. Changes in the ECG template may result in:
Arrhythmia alarm error
Inaccurate HR value
Start relearning:
Select the ECG parameter area to enter the setup menu → [Other Setup] → [Relearn].
Caution
Start the ECG Relearn during normal rhythm and when ECG signal is not noisy. If you
startanECG Relearn during an arrhythmia period, the monitor may collectthe wrong QRS
complex as the ECG template.
11-19
Chapter 12 Manual Defibrillation and Synchronized Cardioversion
12.1 Overview
This chapter introduces how to conduct manual defibrillation and synchronized cardioversion by using pads,
external paddles and internal paddles.
It is necessary to assess patient’s cardiac rhythm correctly and decide whether to conduct asynchronous
defibrillation or synchronized cardioversion before manual defibrillation. Select proper energy level to charge
the defibrillator. During defibrillation, the screen will display text message to indicate the users how to
operate.
In manual defibrillation mode, beside ECG, the monitor can monitor three more physiological parameter. The
physiological parameters displayed on the interface can be adjusted through [Screen Layout].
In manual defibrillation mode, if NIBP measurement is being conducted when charging the vdefibrillator,
NIBP measurement will stop. After shock or disarming the defibrillator, NIBP measurement will auto start if
NIBP measure mode is auto, while NIBP measurement can be started manually if the measure mode is manual.
The alarm is disabled by default when entering the manual defibrillation mode and you can press alarm pause
key to enable the alarms.
Danger
Do not conduct defibrillation in the presence of oxygen-rich atmospheres. When conducting
defibrillation on the patient with oxygen catheter, place the oxygen catheter properly. Do not put
it near the pads to avoid fire and explosion.
During defibrillation, do not allow pads to touch each other or touch ECG electrodes, lead wires,
dressings, etc. Otherwise electrical arcing and patient skin burns could be caused.
During defibrillation, do not touch patient and conductive material (including bed and stretcher)
connected with the patient to avoid potential injury and death.
During defibrillation, do not touch conductive liquid like saline solution, blood and conductive
gel and conductive material like bed and stretcher to avoid forming current path.
Do not use wet hands or the hands with conductive gel to handle the paddles, or the operators
may be shocked.
Warning
Do not use liquid conductive agent. Only the conductive gel specified by our company can be
used.
Do not attach the paddles to your body to verify whether the paddles are connected well.
When using the paddles, put the paddles on patient flatly and push them with equal strength. Do
not push the paddles with too much strength, or patient could be injured.
Select appropriate defibrillation energy level for children.
During synchronized cardioversion, if ECG waveform is obtained through external paddles, the
12-1
Manual Defibrillation and Synchronized Cardioversion
artifacts caused by paddles’ movement may be similar to R wave and trigger defibrillation
shock.
Caution
After therapy, the conductive gel on the paddles should be cleaned immediately to prevent the
paddles from corrosion.
The medical device which has no defibrillation protection shall be disconnected from the patient
during defibrillation.
Attention
Too high impedance could have a great impact on patient’s therapy. Reduce the impact caused
by high impedance to the utmost. When prompt message ―Impedance Too High‖ appears, please
check whether patient skin is clean and dry and whether chest hair has been shaved. If the
prompt message is still there, please replace pads or pads cable.
Alarms are disabled by default when entering asynchronous defibrillation mode with text
message ―Alarm Off‖ displayed in physiological alarm message area. You can enable alarms by
pressing alarm pause key, entering synchronized cardioversion mode or switching to monitor
mode or pacer mode.
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Manual Defibrillation and Synchronized Cardioversion
In defibrillation message area at the middle of manual defibrillation interface, such information about manual
defibrillation as defibrillation mode, synchronized status, energy level, impedance indicator, defibrillation
prompt message, shock times and so on will be displayed.
1. Remove all clothing from patient’s chest. Dry patient’s chest and do skin preparation if necessary.
2. Choose proper therapy cable and insert it into the therapy cable connector on the right panel of the
monitor until a ―click‖ is heard.
3. Place pads or paddles.
Pads: place pads to the patient in the anterior-lateral position or anterior-posterior position
according to the indication on the packaging.
Paddles: hold the handle of paddles with two hands and take the paddles out form the paddle tray.
Apply some conductive gel to the paddles and place them on the patient in the anterior-lateral
position.
Warning
When charging or electric shock, do not touch the parts of the electrode paddle except the
insulated part of the handle, otherwise the operator may receive an electric shock.
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Manual Defibrillation and Synchronized Cardioversion
button on the paddles. When the defibrillator is being charged, the progress bar will be displayed in
defibrillation message area and charge tone will be given out. When the defibrillator is charged well,
charge completed prompt tone will be given out.
If you want to increase or reduce the selected energy level during charge or after charge completed,
change the energy level directly and recharge the defibrillator.
Press the [Disarm] softkey to internally discharge the energy that is being charged or has been charged.
When the electric shock button is not pressed for discharge within the set auto release time, the monitor
will automatically cancel. You can set [Auto Disarm Time] under [Manul Def Setup] under the [Config
Manage] menu.
7. Shock
Make sure the patient needs to be shocked and the charge has been completed. Make sure no one contacts
with the patient and on one contacts with the accessories and equipment connected with the patient.
Shout out ―STAND CLEAR‖ loudly and clearly.
For pads: press the Shock button on the front panel
For external paddles: press the both Shock buttons on the paddles simultaneously.
Attention
200J energy level is recommended for defibrillation for adult.
When using external paddles, the Shock button on the front panel is not available.
Usually, defibrillation is conducted by using paddles or pads. But you can choose ECG lead
wires to conduct ECG monitoring during defibrillation and any available lead can be selected
to display.
Child paddles are installed inside the external paddles. To use child paddles, press the latch in the side of
external paddles and pull the electrodes of external paddles.
For other operating steps, please refer to 12.4 Steps of Manual Defibrillation.
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Manual Defibrillation and Synchronized Cardioversion
Attention
Clean the internal paddles after each use.
Sterilize the internal paddles before use, or serious infection will be caused.
When using internal paddles, the maximum selectable energy level is 50J. Higher energy will
damage the heart.
In manual defibrillation mode, press [Enter Sync] soft button to enter the synchronized cardioversion mode.
The synchronized state will be displayed in defibrillation message area and an R wave mark will be displayed
above each R wave detected as shown below:
12-5
Manual Defibrillation and Synchronized Cardioversion
ECG monitoring can be conducted by pads, paddles and also 3-lead ECG cable, 5-lead ECG cable and 12-lead
ECG cable. Use pads and paddles to give shock.
When conducting synchronized cardioversion, it is recommended to monitor ECG by using 3-lead ECG cable,
5-lead ECG cable or 12-lead ECG cable and give shock by pads and paddles.
When using internal paddles to conduct synchronized cardioversion, it is required to use ECG lead to obtain
ECG signal. Because ECG signal obtained by internal paddles has too much noise, which will result in that
correct R wave cannot be detected. Therefore, ECG signal obtained by internal paddles is not reliable for
synchronized cardioversion.
1. Connect therapy cable and place pads or paddles; if using ECG lead to monitor ECG, connect ECG lead
wire and place ECG electrodes.
2. In manual defibrillation mode, press [Enter Sync] soft button. If [Remote Sync Input] of [Manul Def
Setup] is turned on, select it as required and enter synchronous cardioversion mode.
3. Select the lead. The selected lead must has clear signal and large QRS complex.
4. Make sure the R wave mark appears above the R wave. If the R wave mark doesn’t appear or appear at
the wrong position (like above T wave), select another lead.
5. Make sure the defibrillator/monitor has entered synchronized cardioversion mode with text message
[SYNC] displayed in defibrillation message area.
6. Select energy level.
7. Press the Charge button on the panel. If you are using an external paddle, you can press the Charge
button on the paddle.
8. Make sure the patient needs to be shocked and the charge has been completed. Make sure no one contacts
with the patient and on one contacts with the accessories and equipment connected with the patient.
Shout out ―STAND CLEAR‖ loudly and clearly.
9. Press Shock button. If the external paddles are used, press both Shock buttons on the paddles
simultaneously. When the next R wave is detected, the defibrillator/monitor will give a shock.
Attention
The alarms will auto be enabled after enter synchronized cardioversion.
When giving a shock, you should press and hold the Shock button (or Shock buttons on external
paddles) until the shock is delivered. The monitor will deliver the shock when the next R wave is
detected.
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Manual Defibrillation and Synchronized Cardioversion
If another synchronized cardioversion is required after giving a shock, please do the following steps:
1) Make sure that the monitor is still in synchronized cardioversion mode.
2) Repeat the 4~9 steps of synchronized cardioversion introduced above.
If [Sync Keep] is set to [On], the monitor will still be in synchronized cardioversion mode after giving a shock;
while if it is set to [Off], the defibrillator/monitor will auto exit synchronized cardioversion mode after giving
a shock.
Press [Exit Sync] soft button to exit the synchronized cardioversion mode.
The monitor can realize remote synchronized cardioversion by connecting with the bedside monitor. The
bedside monitor providing ECG signal must have a synchronized defibrillation connector and must be
connected with the data input/output interface of the defibrillator/monitor through the synchronized cable.
Access [Main Menu]→[Config Manage]→enter password→[Manul Def Setup] →[Remote Sync Input] and
select [On] to enable remote synchronized cardioversion function.
Conduct remote synchronized cardioversion following the steps below:
1. Connect the bedside monitor with the defibrillator/monitor through the synchronized cable.
2. Start the defibrillator/monitor and enter manual defibrillation mode.
3. Press [Enter Sync] soft button and the [Sync Mode Select] menu will be displayed as shown below:
4. Select [Remote] to enter remote synchronized cardioversion mode and the text message [Remote Sync]
will appear on the screen.
5. Make sure that each time the bedside monitor detects an R wave, the mark on the monitor will flash
once, which indicates that the synchronized signal has been received once.
6. Connect the therapy cable with the monitor until a ―click‖ is heard.
7. Place pads or paddles.
8. Conduct the remote synchronized cardioversion following the step 6 through step 9 introduced in 12.5.1
Steps of Synchronized Cardioversion.
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Manual Defibrillation and Synchronized Cardioversion
Attention
After entering remote synchronized cardioversion mode, the monitor will not display ECG
waveform and parameter values of the patient. Please view the ECG waveform of the patient on
bedside monitor.
Make sure that the bedside monitor being used has such performance that when performing
remote synchronized cardioversion, the bedside monitor and defibrillator/monitor used
together can deliver shock synchronously within 60ms of detecting the next R wave peak.
The contact impedance indicator is used to indicate the contact impedance of the patient, as shown in the
figure below:
In which
To open the contact impedance indicator, please follow the steps below:
Access [Main Menu]→[Config Manage]→enter password→[Manul Def Setup] →[Contact Imped Prompt]
and select [On] to open the contact impedance indicator.
Attention
It is recommended to conduct defibrillation when the contact impedance is normal. The
defibrillation can also be conducted when the contact impedance is high.
12-9
Chapter 13 Noninvasive Pacing
13.1 Overview
Noninvasive pacing therapy is used to deliver rhythmical pulse to patient’s heart through the pads. When
delivering the pacing pulse once, a white pacing mark will appear on ECG waveform. In the demand pacing
mode, the white R wave mark will appear above ECG waveform until electrical capture occurs.
In pacer mode, the physiological parameters except RESP can be monitored and trigger alarms.
During demand pacing, ECG monitoring should be performed by using ECG electrodes and 3-lead, 5-lead or
12-lead ECG cable. Pacing pulse is delivered through pads, but pads are not capable of monitoring ECG and
delivering pacing pulse at the same time.
Warning
For conducting paicng therapy on the patient with oxygen catheter, please place the oxygen catheter
properly and do not put it near the pads to avoid fire and explosion.
During pacing, the heart rate and alarms given by the monitor may be inaccurate. Keep the patient
under close surveillance and do not rely entirely on the heart rate displayed on the screen.
Caution
If pacing needs to be conducted for a long period, you should check the skin in touch with ECG
electrodes and pads and replace ECG electrodes and pads periodically.
For conducting therapy on the patient with implanted device (like permanent pacemaker or
cardioverter-defibrillator), please consult the doctors or refer to the user manual of the
implanted device.
Attention
Pacer mode supports arrhythmia analysis and give arrhythmia alarms including Asystole,
Ventricular Fibrillation and Ventricular Tachycardia.
If pacing is interrupted for some reason, press [Start Pace] soft button to continue pacing.
In pacer mode, the pacing state of the patient cannot be changed.
If pads do not contact well, prompt message ―Pacer Stopped abnormally‖ and ―Electrode Pad
Off‖ will be displayed.
In pacer mode, pads cannot be used to monitor ECG waveform.
13-1
Noninvasive Pacing
In pacer mode, the monitor can display one ECG waveform and other physiological parameters monitored. In
the pacing message area, such information related to pacing as pacing mode shortcut key, pacing message,
pacing alarm, pacing current and pacing rate will be displayed.
Two pacing modes are provided by the monitor: [Demand Pace] and [Fixed Pace].
Demand pace: the monitor will deliver pacing pulse only when patient’s heart rate is lower than the set
pacing rate.
Fixed pace: the monitor will deliver pacing pulse at the set pacing rate.
During pacing, you can change the pacing mode through the pacing mode shortcut key. The pacing will not
stop when changing the pacing mode and will continue to deliver pacing pulse at the set pacing rate and as the
set pacing current.
Attention
Use demand pacing for most patients. Use fixed pacing only when there is no reliable R wave
detected or there is no available monitoring shock due to interference.
In fixed pacing mode, there is no R wave mark above the pacing QRS complex.
In demand pacing mode, if patient’s heart rate is higher than the pacing rate, the monitor will
not deliver pacing pulse and there will be no pacing mark either.
13-2
Noninvasive Pacing
1. Connect pads cable with the therapy cable connector on the monitor right panel.
2. Make sure that the packaging of pads is intact and pads are not expired.
3. Connect pads with pads cable.
4. Place pads on the patient in the anterior-lateral or anterior-posterior position.
5. For demand pacing mode, use ECG lead cable to monitor ECG. Connect the ECG lead cable and place
ECG electrodes. To receive the best ECG monitoring signal, make sure there is adequate space between
the ECG electrodes and pads.
4. Set the pacing rate. If necessary, set the initial pacing current. Rotate the knob to outline the pacing rate
or pacing electricity hotkey and press the knob, then rotate the knob to change the pacing rate or initial
pacing current and press the knob to confirm the change or set under [Pace Setup] under the [Config
Manage] menu.
5. Press [Start Pace] soft button to start pacing and the pacing message ―Being Pacing.........‖ will appear.
Attention
In demand pacing mode, the monitor will detect the connection of pads cable, pads, ECG cable
and ECG electrodes. If any connection error is detected, the pacing will stop and relevant
prompt message will appear in the pacing message area until the connection is good.
6. Make sure the white pacing marker appears on the ECG waveform, as shown in the figure below:
13-3
Noninvasive Pacing
7. Adjust pacing current: increase the pacing current until electrical capture occurs (Electrical capture is
indicated by a QRS complex following each pacing mark), then adjust pacing current to the lowest level
which can maintain the electrical capture.
8. Confirm the peripheral circulation has a pulse.
To interrupt pacing and view patient’s pulse rate, please press [4:1] soft button. The defibrillator/monitor will
deliver the pacing pulse at one fourth of the set pacing rate. Release the [4:1] softkey to resume sending the
pacing pulse at the set rate.
Press [Stop Pace] soft button to stop pacing. Press [Sart Pace] soft button to restart delivering pacing pulse
after pacing stops.
Caution
The patient’s cardiac output shall be routinely evaluated.
3) If ECG lead is used, press LEAD SELECT button to select the desired lead.
4) Set pacing rate. If necessary, set the initial pacing current.
5) Press [Start Pace] soft button to start pacing and the pacing message ―Being Pacing.........‖ will appear.
6) Make sure the white pacing marker appears on the ECG waveform, as shown in the figure below:
7) Adjust pacing current: increase the pacing current until electrical capture occurs (Electrical capture is
indicated by a QRS complex following every pacing mark), then adjust pacing current to the lowest level
which can maintain the electrical capture.
8) Confirm the peripheral circulation has a pulse.
To interrupt pacing and view patient’s pulse rate, please press [4:1] soft button. The defibrillator/monitor will
deliver the pacing pulse at one fourth of the set pacing rate. Release the [4:1] softkey to resume sending the
pacing pulse at the set rate.
13-4
Noninvasive Pacing
Press [Stop Pace] soft button to stop pacing. Press [Start Pace] soft button to restart delivering pacing pulse
after pacing stops.
Warning
Use pads on patient carefully to avoid shock during pacing.
When operating the monitor on battery in pacer mode, if ―Low Battery‖ alarm triggered, please
connect the monitor to AC power supply or replace the battery with a fully charged one
immediately.
Attention
The monitor or pacer mode may be instable when electrotome and other electronic equipment
are used.
13-5
Chapter 14 AED
14.1 Overview
In AED (Automatic External Defibrillation) mode, the defibrillator/monitor will analyze patient’s ECG
waveform automatically and indicate the users to operate according to the cardiac rhythm monitored.
The monitor starts to perform intelligent analysis after entering AED mode. When a shock able rhythm is
detected, the defibrillator/monitor will give ―shock advised‖ prompt and start to auto charge immediately. If
the patient is found to be unsuitable for electric shock, enter a state where no electric shock is recommended.
Defibrillation intelligence analysis continues throughout the AED process. Defibrillation intelligence analysis
is stopped when the defibrillation monitor enters the CPR state or an abnormality occurs in the connection of
multi-functional electrode pads.
In AED mode, only the ECG signals acquired through the multi-functional electrode pads are displayed. The
monitor will turn off the alarm and parameter measurements, and it is forbidden to enter patient information.
Lead Select, Alarm Pause, NIBP, and Menu buttons are all inactive.
Before entering the AED mode to treat patients, go to the [Config Manage] → [AED Setup] screen to set the
AED routine. See 7.3 AED Settings for details.
Danger
Do not conduct defibrillation in the presence of oxygen-rich atmospheres. When conducting
defibrillation on the patient with oxygen catheter, place the oxygen catheter properly. Do not put
it near the pads to avoid fire and explosion.
During defibrillation, do not allow pads to touch each other or touch ECG electrodes, lead wires,
dressings, etc. Otherwise electrical arcing and patient skin burns could be caused.
During defibrillation, do not touch patient and conductive material (including bed and stretcher)
connected with the patient to avoid potential injury and death.
During defibrillation, do not touch conductive liquid like saline solution, blood and conductive
gel and conductive material like bed and stretcher to avoid forming current path.
Warning
During defibrillation, the bubble between pads and patient skin will cause patient skin burns.
Make sure that pads are placed to patient skin tightly to avoid bubbles.
Do not use dry pads. Use the pads immediately after unpacking them.
AED is only applicable to the patients more than eight years old.
Caution
For the patients with pacemaker, the sensitivity and specificity of AED analysis may decline.
Improper operation on pads during storage or before use will damage the pads. Do not use the
damaged pads.
14-1
AED
In AED mode, the defibrillator/monitor will only display one ECG waveform detected by pads and HR value
calculated from this displayed waveform. The AED message area at the middle of AED interface will display
AED prompt message, contact impedance indicator (settable), shock times and so on.
For the introduction to contact impedance indicator and its setting method, please refer to section 12.7
Contact Impedance Indicator for detail.
There are there soft buttons at the lower right corner of AED interface.
When the defibrillator/monitor is used outdoors, press [HIGH CONTRAST] soft button to view the
display screen clearly.
Verify that the patient is in cardiac arrest without consciousness, pulse or normal breathing.
1. Remove all clothing from patient’s chest. Dry patient’s chest and do skin preparation if necessary.
2. Place pads on patient in the anterior-lateral position according to the indication on packaging.
3. Connect pads with pads cable. Connect pads cable with the therapy cable connector on the
defibrillator/monitor right panel until a ―click‖ is heard.
4. Rotate the mode selector to AED.
In AED mode, the defibrillator/monitor will detect the connection of pads cable and pads. If any
connection error is detected, relevant prompt message will appear in the AED message area until the
connection is good.
5. Perform AED following the voice prompt and prompt message.
14-2
AED
The monitor will analyze patient’s cardiac rhythm based on the ECG waveform detected by pads and
give a warning of ―Not Contact Patient‖. When a shock able rhythm is detected, the defibrillator/monitor
will start to auto charge immediately.
The voice prompt can be enabled or disabled in [Config Manage] menu or by pressing the soft button
below .
6. If there is a shock advised, press the Shock button on the front panel.
After charge completes, the monitor will give out ―Do not touch patient! Press shock button‖ voice
prompt. At this moment, check that no one touches the patient and accessories or equipment connected
with the patient and shout out ―STAND CLEAR‖ loudly and clearly. Then press the Shock button on the
front panel to deliver a shock.
After shock, the monitor will give ―Energy Delivered‖ voice prompt and text message. The shock times on the
screen will update to indicate the number of shocks has been delivered. If the [Serial Shock Times] is set as
more than one, the monitor will restart to analyze patient’s cardiac rhythm after a shock being delivered and
estimate whether the shock is successful. There will be voice prompt and text message for indicating the users
to perform more shocks.
Attention
Do not place pads in the anterior-posterior position. The AED algorithm of this monitor has
not been verified under the anterior-posterior placement.
Keep patient still during cardiac rhythm analysis in order to prevent misdiagnosis and delayed
diagnosis.
The monitor will not deliver shocks automatically. Shocks will only be delivered by pressing
Shock button.
Too high impedance could have a great impact on patient’s therapy. Reduce the impact caused
by high impedance to the utmost. When prompt message ―Impedance Too High‖ appears,
please check whether patient skin is clean and dry and whether chest hair has been shaved. If
the prompt message is still there, please replace pads or pads cable.
If the shock able cardiac rhythm is detected, the defibrillator will be auto charged to the set energy level and
charge tone will be given out. The Shock button will flash after charge completes.
14-3
AED
The cardiac rhythm analysis will continue during charge. If the situation that the cardiac rhythm has changed
and is not suitable for shock before delivering a shock is detected, the defibrillator will disarm the energy
automatically.
After the monitor gives out voice prompt ―Do not touch patient! Press shock button.‖, if the users do not press
Shock button during the interval set in [Auto Disarm Time], the defibrillator will disarm the energy
automatically and restart cardiac rhythm analysis.
Press [Pause Analysis] soft button to disarm the defibrillator at any time during charge or after charge
completes.
Initial shock energy recommended for adult patient is 200J.
When there is no shock able rhythm detected, the monitor will give ―No Shock Advised!‖ prompt message.
If NSA process mode is set as:
[CPR]: Enter CPR, the monitor will give out voice prompt ―No shock advised, Pause, if needed, start
CPR‖ and display text prompt ―Pause, If Needed, Begin CPR‖ in AED message area. CPR countdown
will also appear.
[Continue Analysis]: The monitor will continue to monitor patient’s ECG and analyze the potentially
shock able cardiac rhythm. Before shock able cardiac rhythm being detected, the monitor will give out
voice prompt ―No shock advised. If needed, pause analysis for CPR‖ repeatedly and display ―No Shock
Advised!‖ and ―Being Monitoring....‖ text prompt circularly. The frequency of the language prompt can
be set in [Voice Interval] in [AED Setup].
You can press [Pause Analysis] soft button to stop analysis and start CPR. [CPR Time] can be set in [AED
Setup].
After CPR, the monitor will resume analysis, or during CPR, you can press [Recovery Analysis] soft button to
resume cardiac rhythm analysis.
14.7 CPR
If the [Pre-Shock CPR Time] isn’t set to [Off], the system will enter initial CPR after entering AED mode.
The users can set the pre-shock CPR time or disable the initial CPR function in [Pre-Shock CPR Time].
After finishing the serial shocks, the monitor will pause analysis and enter CPR. The CPR countdown will
start and voice prompt ―Pause, If Needed, Begin CPR‖ will be given out. After CPR, the monitor will resume
analysis. During CPR, you can press [Recovery Analysis] soft button to resume cardiac rhythm analysis.
During serial shocks, if you press [Pause Analysis] soft button after a shock delivered, the monitor will enter
CPR. The CPR duration can be set in [CPR Time] in [AED Setup].
14-4
AED
After enter CPR, the monitor provides the CPR metronome function and indicates the operators to press the
patient’s chest 120 times per minute which is recommended by AHA/ERC and perform ventilation.
You can enable and disable the CPR metronome function in [CPR Metronome] in [AED Setup].
The CPR metronome is turned on by default. With the CPR metronome turned on, you can set the CPR
compression/ventilation ratio by selecting [CPR Mode]. The default compression/ventilation ratio is 30:2.
Warning
CPR metronome doesn’t prompt the current condition of the patient. The operators should assess
patient’s condition constantly because patient’s condition may vary in a very short period. Do not
perform CPR on the patients with response and normal breathing.
Attention
CPR metronome can be affected by the on/off state of AED voice prompt and the settings of
voice volume.
In AED mode, the system can tape the whole therapy process.
You can enable the audio recording function by accessing [Config Manage]→[AED Setup]→[Audio
Recording]and select [On].
After audio recording function is enabled, symbol will appear at the upper right corner of the AED
message area.
The system can store audio recording up to 240 min and store audio recording of 60 min for each patient.
14-5
Chapter 15 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 generate a RESP wave on the screen. The RR is calculated
from such wave.
1 3
2
1. Resp Waveform 2. Resp Alarm Limit 3. Value
In Resp measurement, it is important to prepare the skin properly for electrode placement. Refer to the ECG
measurement for relevant information.
The Resp signals are measured through the two ECG electrodes. When the ECG electrodes are placed in
standard position, 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. When that the Resp
electrodes collect the rhythmic blood flow causes the impedance changes, the phenomenon occurs. Proper
placement of electrodes can reduce cardiac superposition.Avoid the liver area and ventricles in the line
between the electrodes, which is especially important to neonates.
15-1
Resp Monitoring
3) Abdominal Respiration
Some patients may have restricted thoracic movements and rely mainly on abdominal respiration. To obtain
the best Resp waveform, place the electrode LL on the left abdomen with strongest expansion, as shown
below:
Attention
Place the green and red electrodes diagonally for the best respiratory wave. The liver region
and ventricle should be avoided by connecting them to the respiratory electrodes, so as to avoid
the false difference of cardiac coverage or pulsating blood flow, which is especially important
for newborns.
Respiratory monitoring is not appropriate for patients with a high range of activity because it
can lead to false alarms.
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
computution method.
15-2
Resp Monitoring
[Auto] mode:
The monitor automatically 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.
Select [Auto] mode if:
The RR is not approximate to the HR;
The patient relies on mechanical ventilation (except intermittent mandatory ventilation (IMV)).
[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].
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 do not improve the Resp detection level due to small Resp waveform size, follow the
instructions of Lateral Thoracic Expansion in Section 15.3.1 Optimization of Lead Position to optimize the
position of the electrodes.
15.5.1 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 [RespWave] and select an appropriate [Gain].
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 automatically selects the appropriate Resp lead.
1) Select the Resp parameter area to enter [Resp Setup] → [Resp Lead].
15-3
Resp Monitoring
No-breath detection is to detect the longest interval between two respirations. When the actual no-breath time
of the patient exceeds the set no-breath time, the monitor responds 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 [Resp Setup] → [No Breaths Timeout] and set an appropriate
detection time.
Set [No BreathAlm Delay]:
1) Enter [User Maintain] → [Other Setup].
2) Set [No BreathAlm Delay] to [Close], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or
[1min].
If you select [Close], the alarm delay function will be disabled.
This parameter is designed to filter out the Resp interference. Its default is [On].
1) Select the Respwave area to enter [RespWave].
Note
In Resp measurement, the monitor cannot recognize any obstructive or mixed nobreathing but
trigger an alarm when the interval between two respirations exceeds the set time.
15-4
Chapter 16 SpO2 Monitoring
16.1 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 has 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 left side sensor connector of the monitor:
Standard SpO2 sensor:
Sensor connector: circular white connector at the side panel;
Silkscreened logo: SpO2.
Masimo SpO2 sensor:
Sensor connector: circular blue connector at the side panel;
Silkscreened logo: MasimoSET.
Nellcor SpO2 sensor:
Sensor connector: circular blue connector at the side panel;
Silkscreened logo: Nellcor.
The information about wavelength range and maximum optical output power of the sensor is useful to the
clinician for some therapy, for example, photodynamic therapy.
The Standard SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).
16-1
SpO2 Monitoring
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 905nm (IR LED).
The maximum optical output power of the sensor is lower than 15mW.
Warning
The monitor can automatically recognize the SpO2 sensor type. However, the monitor is
connfigured with a specific internal SpO2 hardware before delivery, the monitor cannot
measure SpO2 if using a incompatible sensor.
Pleth waveform Signal Identification and Quality Alarm limit SpO2 value PI value
Warning
The monitor is compatible with the SpO2 sensor designated by our company only. Before
monitoring the patient, check the sensor and extension cord are compatible with the monitor.
Incompatible accessories reduce the performance of the monitor.
Before monitoring the patient, check the sensor cable works properly. Remove the SpO2 sensor
cable from the sensor interface and the monitor displays the prompt message ―SpO2Finger off‖
and triggers the alarm sound.
If the SpO2 sensor or its package seems damaged, do not use it. Return the damaged product to
the manufacturer.
Long-time continuous monitoring increases 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, adhere the sensors properly and check the sensors position regularly
based on skin quality (change the sensor position whenthe skin quality decreases). Perform such
check frequently if necessary (subject to the condition of the patient).
Make sure the sensor cable and the electrosurgical equipment cable are not intertwined.
Do not place the sensor on a limb with ductusarteriosus or intravenous tube.
Setting the high SpO2 alarm limit to 100% disables the high-limit alarm. Premature infants may
16-2
SpO2 Monitoring
get infected with crystalline posterior fibrous tissue diseases in case of high SpO2. Please set the
high 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 where it might fall on the patient.
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 substances in combination with airor nitrous oxide or in oxygen-enriched
environment.
To ensure safety, avoid stacking multiple equipments or placing anything on the equipment
during operation.
To protect against injury, follow the directions below:
Do not soak or immerse the equipment in liquids.
Do not attempt to sterilize the equipment.
Use cleaning solutions only as instructed in this operator's manual.
Do not attempt to clean the equipment 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, such as thalassemias, Hb
s, Hb c, sickle cell, etc.
Hypocapnic or hypercapnic conditions.
Severe anemia
Very low arterial perfusion.
16-3
SpO2 Monitoring
Cautions
Do not place the pulse oximeter where the patient can control it.
Electrical shock and flammability hazard: Before cleaning, always turn off the equipment and
disconnect from any power supply.
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 normal work of the
oximeter.equipment
If SpO2 values indicate the possibility of the hypoxemia, a laboratory blood sample should be
taken to confirm the patient’s condition.
If using pulse oximeter during full body irradiation, keep the sensor out of the radiation field. If
16-4
SpO2 Monitoring
the sensor is exposed to the radiation, the reading might be inaccurate or the equipment might
be zero for the duration of the active irradiation period.
To ensure that alarm limits are appropriate for the patient 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 made to completely
understand the patient’s condition.
Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilize by autoclave,
irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse
oximeter.
Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-
applied circuits and the system are within acceptable limits as specified by the applicable safety
standards. The summation of leakage currents must be checked and in compliance with IEC
60601-1 and UL60601-1. The system leakage current must be checked when connecting external
equipment to the system. When an event such as a component drop of approximately 1 meter or
greater or a spillage of blood or other liquids occurs, retest before further use. Injury to
personnel could occur.
Disposal of product - Comply with local laws in the disposal of the equipment and/or its
accessories.
To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse oximeter.
Notes
High-intensity extreme lights (such as pulsating strobe lights) directing on the sensormay not
allow the pulse oximeter to provide 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.
Replace the cable or sensor if the instructions in the manual after fistly tried don't work when a
low SIQ message is displayed in the process ofconsistently monitoring patients.after completing
troubleshooting steps listed in this manual.
16-5
SpO2 Monitoring
Notes
When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be
compromised. If the equipment is in this setting and the sensor becomes dislodged from the
patient, 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 equipment, 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
A functional tester cannot be used to assess the accuracy of the pulse oximeter.
Assess the SpO2 accuracy by comparing the readings respectively on the monitor and CO-oxygen pressure
gauge.
This monitor measures 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.
16-6
SpO2 Monitoring
Warning
Place the SpO2 sensor properly based on the SpO2 sensor type. This is especially important
for neonates.
Monitor SpO2:
1) Set the patient type;
2) Insert the SpO2 cable connector into the SpO2connectorof the monitor;
16-7
SpO2 Monitoring
In operations, the following factors may affect the SpO2 measurement accuracy:
1) High-frequency radio interference, whether from the monitor or from the electrosurgical equipment
connected to the monitor. To minimize radio interference, other electrical equipment that emits high-
2) Do not use the oximeteror SpO2 sensor duringMRI scanning, or the induced current may cause burns.
3) Intravenous dyes.
16-8
SpO2 Monitoring
8) The sensor is placed on a limb with blood pressure cuff, ductusarteriosus or intravenous tube.
12) The shock, anemia, hypothermia and vasoconstrictors may reduce the arterial blood flow to a level that is
not measureable.
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.
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [SatSecond] (Saturation Seconds).
The smart alarm is designed to reduce false alarms and keep the clinician informed of the SpO2 changes more
accurately and timely. For example, if you set [Sat second] to [50] and the high and low alarm limit of
NELLCOR SpO2 respectively to 97% and 90%, and the measured SpO2 value keeps at 80% for 3s and then to
78% for 2s, the monitor will provide audible and visual alarm indications 5s after the SpO2 value goes beyond
the alarm limit and the circle beside the SpO2 value will return to the origin.
Calculation method:
Percentage points × seconds = Sat second (integer)
The calculated Sat second is displayed as follows:
% SpO2 Seconds Sat second
(90%-80%) × 3 = 30
(90%-78%) × 2 = 24
16-9
SpO2 Monitoring
Fig 16-5AnExample
If smart pulse tone is enabled, you can hear the pulse tone even when the signal is unstable or the equipment is
in a noisy environment.You won’t hear the pulse tone in the case of unstable signal or ambient noise if this
function is disabled.
Set [Smart Tone]:
1) Select the SpO2 parameter area to enter [SpO2 Setup].
16-10
SpO2 Monitoring
If you do not select [ON], the weak perfusion caused by NIBP measurement leads to inaccurate SpO2
measurement or trigger aphysiologicalSpO2 alarm when the NIBP measurement and SpO2measurement
are performed on the same limb.
If this function is enabled and the displayed SpO2 value is not based on an appropriate signal quality, the
monitor displays a visible plethysmogram indicating the signal quality and the patient’s pulse events.
Movements usually affect the signal quality. When the arterial pulse reaches the peak, the monitor marks its
location on the vertical line (signal indicator). The smart tone volume (if enabled) remains consistent with the
indication in 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].
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:
Masimo SpO2:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Average Time].
If this function is enabled, the monitor performs the SpO2 measurement as 2-4 or 4-6 seconds of the average
time.
1) Select the SpO2 parameter area to enter [SpO2 Setup].
2) Select [Fast Sat] (Fast Saturation) to switch between [On] and [Off].
16-11
SpO2 Monitoring
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 screen.
16.9.8 Sensitivity
[Sensitivity] can be set to [Normal], [Maximum] or [APOD] (Adaptive Probe Off Detection). [APOD]
represents the highest sensitivity. In typical monitoring conditions, select [Normal]. If the sensor is likely to
fall off the patient due to wet skin, violent movement or other causes, select [Maximum]. If the patient’s
perfusion level is extremely low, select [APOD].
Set [Sensitivity]:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Sensitivity].
16-12
Chapter 17 NIBP Monitoring
17.1 Overview
NIBP monitoring is applicable to adults, children, neonates, pregnant women and pre-eclampsia patients
The monitor uses the vibration method (measuring the cuff pressure vibration amplitude) to measure the
noninvasive blood pressure (NIBP). Blood pressure changes cause the cuff vibration. The pulse wave range
varies from the cuff pressure and when the maximum pulse wave range is obtained, according to the
corresponding proportionality calculating the pulse wave ranges of systolic and diastolic pressure, the systolic
pressure and diastolic pressure can be obtained. The BP values measured by this equipment are equivalent to
the values measured by invasive method. The error complies with the requirements of IEC80601-2-30. The
brachial artery is selected for verification in the clinical trials using the invasive method.
When making measurements on children and newborns, it must be ensured that the correct mode setting has
been selected (see Patient Information Menu Settings). Using the wrong patient mode may jeopardize patient
safety as higher adult blood pressure levels are not applicable to children and newborns.
NIBP measurement can be applied in electrosurgical operations and defibrillator discharges according to
IEC80601-2-30.
The NIBP measurement results are displayed in the parameter area. The figure below is for reference only.
The actual display may be slightly different from this figure.
② ⑥ ③ ④
⑦ ⑤
17-1
NIBP Monitoring
Warning
Before the NIBP measurement, make sure the selected monitoring mode is appropriate for the
patient (adult, pediatrics or neonate). It is dangerous to select a non-neonatal mode for
neonatal patients.
Do not place the cuff on a limb with intravenous infusion or cannulain place, 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 entangled.
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 could cause blood flow disturbance 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 disturbance will injure the patient.
Do not place the cuff on the arm at the same side as mastectomy.
The increasing cuff pressure could cause transient function failure to other monitoring
equipment used on the same limb.
2) Connect the inflation tube to the NIBP connector of the monitor without compressing or blocking the
pressure tube.
3) Use the correct size cuff and make sure the airbag is not folded or twisted.
An incorrect cuff size or a folded or twisted airbag causes 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 circle 50~80%
17-2
NIBP Monitoring
of the limb.
4) Wrap and secure the cuff around the limb and make sure the cuff is at the same level as the patient’s heart.
If you fail to do so, use the following methods to correct the measurement result:
Make sure the mark ―φ‖ is located at an appropriate artery. Do not wrap or secure the cuff too tightly,
or the distal extremity may suffer from discoloration or ischemia. Regularly check the skin
condition of the contact part and the color, temperature and feeling of the limb which wearsthe cuff.
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
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) ×
If the cuff is at a lower level than the heart: displayed NIBP value - 0.75mmHg (0.10kPa) × level
difference (cm).
The vibration method has some restrictions, depending on the patient’s condition. The vibration method
detects the regular pulse wave generated by arterial pressure. If the patient’s condition makes it difficult to
detect such waves, the measured pressure value is unreliable and the pressure measurement time increases. In
the following cases, the pressure measurement is affected.
1) Patient Movement
If the patient is moving, trembling or under cramps, which may affect the detection of arterial pressure pulse,
the NIBP measurement is unreliable or impossible and the pressure measurement time will increase.
2) Arrhythmia
If the patient has irregular heartbeats due to arrhythmia, the NIBP measurement is unreliable or impossible
and the pressure measurement time increases.
17-3
NIBP Monitoring
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 is unreliable or impossible.
5) Severe Shock
If the patient is under severe shock or hypothermia, the NIBP measurement is unreliable as the reduced blood
flow to the periphery will cause lower arterial pulse.
6) Extreme HR
Do not perform the NIBP measurement if the HR is lower than 40bpm (beats per minute) or higher than
240bpm.
7) Obese Patient
Due to the thick fat layer of the limb, the vibration from the artery fails to reach the cuff, which causes lower
measurement accuracy than in normal weight cases.
8) Patient with Hypertension
To measure the NIBP of a patient with hypertension accurately, follow the steps below:
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 the patient to relax as much as possible and not talk during the measurement.
Select the NIBP parameter area to enter the setup menu→[Measure Mode]→[Manual] or selectquick key
[ModeSetup], then select [Manual]. Whether to start the NIBP measurement 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‖.
17-4
NIBP Monitoring
2. Select the [NIBP] key on the control panel and manually start the first measurement. After the first
measurement, the monitor will automatically and repeatedly start the measurement according to the
Note
The monitor operate the [Whole point Mea.] only when the [Interval] is not less than 5min.
1. Select the NIBP parameter area to enter the setup menu→[Measure Mode]→[Auto].
3. Select the [NIBP] key on the control panel and manually start the first measurement. After the first
measurement, the monitor will automatically and repeatedly start the measurement according to the
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 before
checking the monitor functions. Use the same method for checking the monitor as checking
the patient.
In order not to injure the patient, the [Continual Measure] mode is not available for the
patient [Neo].
The automatic 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.
17-5
NIBP Monitoring
When a measurement is complete, the monitor can automatically deflateand stop the measurement. During the
measurement, you can pressthe [NIBP] key on the control panel to stop the measurement.
The patient type includes adult, pediatric and neonate. The patient type is the same as the setting 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 theparameter 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
the blood pressure pump and automatically recover in the event of failures.
Inflate the NIBP cuff to a pressure approximate to the diastolic pressure to block the vein vessel and assist in
venipuncture.
1) Select the NIBP parameter area to enter [NIBP Setup] → [Other Setup] → [Cuff Pressure] and then
4) Press the [NIBP] key or the [Venipuncture Stop] key to deflate the cuff. If you fail to do so, the cuff
17-6
NIBP Monitoring
In the venipuncture process, the NIBP parameter area displays the cuff pressure and remaining time of
venipuncture.
17-7
Chapter 18 Temp Monitoring
The monitor has two Temp measurement channels and uses a TEMP probe to measure the Temp.
Place the Temp probe under the patient’s axilla or on the patient’s anus, depending on the probe type. To
obtain an accurate measurement result, leave the probe in place to measure the Temp for at least 3min.
The parameter area displays 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].
Temp Unit
Alarm Limit
Warning
The work mode of the Tempprobe is the direct mode.
Before the Temp measurement, check if the Tempprobe cable is in good condition. Remove the
Temp sensor cable from the Tempprobeconnector, and the monitor displays the prompt message
[T1 (T2) sensor off] and triggers the alarm sound.
Handle the Tempprobe and cable with caution. When they are not in use, coil them loosely. Tight
coiling may cause mechanical damage to the cable.
Calibrate the Temp module at least every two years or as required by the hospital’s regulations.
Contact the manufacturer for calibration when necessary.
Note
Do not reuse any disposable Temp sensor.
18-1
TEMP Monitoring
2) If you are using a disposable Temp probe, connect it to the Temp cable.
3) Connect the Temp probe or Temp cable to the Temp sensor connector of the monitor.
18-2
Chapter 19 CO2 Monitoring
19.1 Overview
The monitor uses the CO2 measurement to monitor the patient’s respiration status and control patient’s
ventilation. There are two methods of measuring the CO2 in the patient’s airway:
Sidestream measurement method: take sample from the respiratory gas module in the patient’s airway at
a constant flow rate and use the built-in remote CO2module in the measurement system to analyze them.
The measurement principle is IR emission. Use theoptical detector to measure the intensity of the infrared
rays penetrating the respiratory system. The intensity depends on the CO2 concentration as some infrared ray
is absorbed by CO2molecules.
The CO2 measurement involves the following parameters (see the figure below):
CO2 waveform ①
End-tidal CO2 (EtCO2): the maximum partial pressure ofCO2 at the end of respiration②
Fraction of inspiratory CO2 (FiCO2): the minimum CO2 value during inspiration ④
Airway respiration rate (AWRR): the respiration per minute calculated from the CO2 waveform ⑤
Measurement unit ⑥
④ ⑥
③ ② ⑤
Warning
Try to avoid collision and vibration of the CO2 module.
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.
19-1
CO2 Monitoring
The CO2 measurement principle is mainly based on the feature that CO2 can absorb infrared light with a
wavelength of 4.26 um. The measurement method is to send CO2 gas to the measurement chamber. One side
is irradiated with infrared rays, and the other side is measured by a sensor to measure the degree of attenuation
of the received infrared rays. The degree of attenuation is proportional to the CO2 concentration.
The conversion relational expression between CO2 partial pressure and CO2 concentration is:
CO2 partial pressure (mmHg) = CO2 concentration (%) ×Pamp (ambient pressure)
For instance: 5% CO2 at 760mmHg = 38mmHg
5% CO2 at 700mmHg = 35mmHg
The CO2 module uses the Autorun command measurement mode, and the waveform sampling rate is
performed every 31 milliseconds.
1) Insert the sidestream CO2 module into the monitor’s module slot.
3) Wait for 10s (Masimo) or 2min (Respironics) until the module reaches its working temperature and a
4) Connect the cannula, airway adapter or sampling line to the module reliably until you hear a click.
To the monitor
19-2
CO2 Monitoring
To the Monitor
CO2 Sensor
Sensor Adapter
5) Use the airway adapter for the intubated patient: install the airway adapter onto the proximal end of the
respiration circuit, exactly between the elbow and the Y-shaped line of the ventilator.
6) Use the nasal cannula for the non-intubated patient: Place the nasal or oral-nasal O2 cannula onto the
patient’s face, connect the O2 supply line to the O2 supply system and set the O2 flow as directed.
Warning
Check the airway adapter before use. Replace the adapter if the airway adapter has any
exterior damage or breakage.
When the CO2module is not in use, turn it off to extend its service life.
19-3
CO2 Monitoring
Analyzer
2) Select [Screen Layout] to display the CO2 waveform and parameter to be monitored (skip this step if the
3) Set [O2 Compensate] in [CO2 Setup]. Set the appropriate [O2 Compensate] in the [CO2 Setup] menu. In
general, the value of this item is recommended to be set to FiO2 minus 5%.
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 19-1 to select the relevant local altitude (the barometric
19-4
CO2 Monitoring
Table 19-1
Note: It is assumed that the barometric pressure is 760mmHg and the temperature is 0℃ at the sea level.
Calculation of Atmospheric Pressure: it is based at the sea-level and the ambient temperature at 0℃. Then you
can refer to this table.
Warning
The monitor has no automatic air compensation function. Set the correct altitude before using
the CO2 measurement function for the first time. Incorrect altitude causes 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 screen. Do not start the CO2 measurement until such prompt message disappears.
19-5
CO2 Monitoring
Follow the steps below to set themonitor for gas analysis purpose:
1) Follow the steps in Section 19.3 to connect the CO2module based on the CO2module type.
2) Connect the Nomoline sampling tube to the input port of the ISA analyzer.
3) Connect the cable of the ISA analyzer to the CO2connector of the monitor.
5) Enter the regular screen of the monitor and select [Screen Layout] to display 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 scavenging system or make the gas flow back to the patient circuit.
8) The green LED indicates that the ISA analyzer is ready for use.
9) Follow the steps in Section 19.5.2 to perform the checks before use.
10) Start the CO2 monitoring if all the checks are normal.
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 module.
2) Check if the LED remains a steady green (an indication of normal system).
3) Exhale into the sampling tube and check if the monitor displays the effective CO2 waveform and value.
4) Block the sampling tube with a fingertip and wait for 10s.
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
To prevent the condensed water from dropping into the gas sampling tube and blocking it, the
gas sampling tube connection end of the airway adapter should point upwards.
19-6
CO2 Monitoring
Warning
Securely hang the external CO2 analyzer onto the CO2holder on the back housing of the
monitor so it does not fall and damage.
Unless HME is used to protect the IRMA sensor, the LED state indicator should face upwards
all the time during IRMA sensor placement.
Do not pull the cable of the ISA sidestream gas analyzer.
Do not operate the ISA sidestream Gas Analyzer in the environment beyond the designated
operating temperature.
Make sure all connections are firm and reliable.Any leakage will result in the inclusion of
ambient air in the patient’s respiratory gas, which leads to a wrong reading.
Follow the steps below to set CO2 work mode after connecting the CO2module to the monitor. Turn off the
CO2module for service life protection purpose once the CO2 measurement is stopped.
1) Select the CO2 parameter area to enter [CO2 Setup] → [Work Mode].
19-7
CO2 Monitoring
Warning
Set [O2 Compensate] and [N2O Compensate] based on the actual conditions, or the
measurement results could differ greatly from the actual values which can 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 apnea time, the monitor responds to apnea alarms according to the value of
[No BreathAlmDelay].
To set the [No Breaths Timeout]:
1) Select the CO2 parameter area to enter [CO2 Setup] → [No Breaths Timeout] and set an appropriate
detection time.
To set the [No Breath Alm Delay]:
1) Enter [User Maintain] → [Other Setup].
2) Set [No BreathAlm Delay] to [Off], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or
[1min].
If you select [Off], the alarm delay function is disabled. The monitor responds to no-breath alarms (if any)
immediately.
19.6.5 Altitude
3) Set an altitude value, and the monitor is automatically set to [Baro. Pressure] (Barometric Pressure)
Only the Respironics CO2module requires setting the balance gas manually (for Masimo CO2 module, the
balance gas is automaticallyset).
1) Select the CO2 parameter area to enter [CO2 Setup] → [Balance Gas].
19-8
CO2 Monitoring
If you adjust the scale value, the waveform amplitude changes accordingly.
Select the CO2 waveform area to enter [Waveform Setup] → [Scale].
CO2Module
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 air dry the washed cloth. Make sure the module’s sight glass is clean air dried before
use.
The above disinfection methods allow you to reuse the airway adapter for 100 times.
19.7.4 Zeroing
Usually, the CO2moduleis automatically zeroed when necessary. You can zero it manually as you consider it
necessary: select [CO2] in the parameter area to enter [CO2 Setup] and then select [Zero] to zero the
CO2module. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) for 30s in the zeroing process.
The CO2module is zeroed successfully when the prompt message ―Zeroing, please wait 30s‖ disappears.
19-9
CO2 Monitoring
19.8.1 Zeroing
In order to eliminate the effect of the baseline drift on measurement results and obtain accurate measurement
results, zero the sensor before using the CO2module to monitor the patient.
Usually, the CO2moduleis automatically 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
CO2module. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) in the zeroing process. The
CO2module is zeroed successfully when the prompt message ―CO2 is zeroing‖ disappears.
The ISA CO2Module requires 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. If ISA sidestream gas Module is equipped with the oxygen sensor, auto-
zeroing will include the calibration of indoor air of the oxygen sensor.
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.
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
1) The following factors are known adverse effects on the specified performance:
Quantitative effects of RH or condensation;
19-10
CO2 Monitoring
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, 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 displays 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 enters 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:
19-11
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 equipment 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
equipment 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 equipment 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.
19-12
CO2 Monitoring
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 are/is used, you should prevent these gases from polluting the
operating room. 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: If you measure the parameter of a patient who is using or recently has usedan
anesthetic, the gas discharging port on the module must be connected to a scavenging system or
the patient circuit (on the anesthesia machine or the ventilator), 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 for 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.
19-13
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 /
Not sterile, latex free The monitor is latex free and not sterile.
19-14
CO2 Monitoring
19.8.10 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
can remove the 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 reusable configurations.For instance, the
disposable Nomoline Airway adapter Set or a combination of the reusable Nomoline Adapter and a disposable
Nomoline Extension / T-adapter, is available for the intubated patient. For spontaneously breathing patients,
similarly a disposable Nomoline Nasal CO2 Cannula or a combination of the reusableNomoline Adapter and a
disposable Nomoline Nasal CO2 Cannula (with Luer Connector) can be applied.
OR
The disposable Nomoline Airway Adapter Set is an alternative to the combination of the reusableNomoline
Adapter and a disposable Nomoline Extension / T-adapter.
19-15
CO2 Monitoring
The Nomoline Adapter may be used with other third party sampling lines and cannulas. However, note that
the Nomoline Family sampling lines are designed for optimal performance and measurement 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 risk of sampling line occlusion (see below)
For optimal water handling, always use T-adapters with the sampling point in the center of the adapter, as
shown to the left above.
Note
Using sample tubes or cannulas with larger inner diameter than 1 mm will increase the response
time of ISA system.
19.8.11 Maintenance
The user should verify gas readings regularly; If any problem, 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 cloth to clean the analyzer..
In order to prevent the cleaning liquid and dust from entering into the ISA gas analyzer through the LEGI
connector, the Nomoline sampling line should be connected all the time during analyzer cleaning.
Warning
The Nomoline sampling line is not a sterile equipment. In order to prevent the sampling line
from causing damages, do not carry out high-pressuresterilization on any part of the sampling
line.
Do not sterilize the ISA sidestream gas analyzer and the IRMA probe or soak them into a
liquid.
19-16
Chapter 20 IBP Monitoring
20.1 Overview
The monitor measures the artery pressure (systolic pressure, diastolic pressure and mean pressure).
Warning
Use the pressure sensor specified herein only.
Only use the accessories compliant with the safety requirements on medical equipment. Please
refer to the attached user manual for the sterilization identification.
Do not touch the metal parts connected to electrical equipment when connecting or using any
accessory.
When the monitor is connected to the highfrequency electrosurgicalequipment, to protect
patient from burns (resulted from electric leakage), do not allow the sensors and cables of
monitor to contacthigh-frequency electrosurgical equipment.
Never reuse the disposable pressure sensor.
Before monitoring the patient, check if the sensor cable works properly. Remove the IBP sensor
cable from the sensor connector, and the Monitor displays the prompt message [IBP sensor off]
and triggers the alarm sound.
If any liquid other than the solution used for the perfusion pressure tube and 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.
If any signs of damage or aging are found on the sensor, cable, and pressure tube, replace the
sensor, cable, or pressure tube immediately prior to use.
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
process. Once the defibrillation is complete, the monitor returns to normal within 10s and user configurations
remaining unaffected.
20-1
IBP Monitoring
Note
Calibrate the sensor, whether new or used, regularly according to the relevant procedures of
the hospital.
2) Prepare the pressure tube and sensor by filling the system with the physiological saline solution. Make
3) Connect the patient catheter to the pressure tube. Make sure there is no air in the catheter, pressure tube
or sensor.
4) Plug the power cable into the relevant socket and check if the monitor is powered on.
6) Enter the normal screen of the Monitor and select [Screen Layout] to display the IBP waveform and
parameter to be monitored (skip this step if the IBP waveform and parameter are already displayed on the
screen).
7) Place the sensor at the same level as the heart (approximately at the mid-axillary line).
8) Zero the sensor. After the zeroing is successful, close the end of the sensor to atmosphere and open the
end to patient.
Warning
If there is any bubble in the pressure tube or sensor, use the infusion solution to flush the
system. Bubbles lead to inaccurate measurement.
To perform the ICP measurement to a sitting patient, adjust the sensor to the same level as the
patient’s ears. Incorrect sensor position leads to inaccurate measurement.
20-2
IBP Monitoring
Anticoagulant
Saline Pressure
Sensor
Valve Three-way
Cock
Pressure Sensor
Dropping Pipette
Interface Cable
Monitor
Note
Zero the sensor before monitor the patient. In the IBP monitoring process, keep the pressure
sensor at the same level as the patient’s heart. To avoid catheter clogging, continuously flush
the catheter with the heparin saline to keep the pressure measurement path unobstructed.
Secure the catheter reliably against displacement and disconnection.
To prevent inaccurate measurement, zero the sensor every day or as required by the relevant regulations of the
hospital.
Zero the sensor in the following conditions:
When using a new pressure tube or sensor;
3) Select the IBP parameter area (any displayed channel) to enter [IBP Setup] and select [Zero] (the zeroing
result is displayed when the zeroing operation is complete). You can also select [IBP Zero] (quick key) in
4) Once the sensor zeroing is successful, close its end to atmosphereand open its end to patient.
20-3
IBP Monitoring
[IBPx: XXX]: ―x‖ refers to the IBP channel and ―XXX‖ refers to the current pressure name of such channel.
Enter [Screen Config] to change the pressure name (select an appropriate pressure name from the table below).
Pressure Name Description
Ao Aortic pressure
Two channels of waveforms can be displayed in the IBP waveform area. To enable this function, follow the
steps below:
1) Enter [Main Menu] → [Screen Config] → [Screen Layout].
2) Select IBP waveform and then select the two IBP parameters in monitoring.
1) The two channels of the module use the same filter mode. Select the waveform of either channel to enter
20-4
IBP Monitoring
[IBPx: XXX Wave] and then set [Filter Mode] to [No Filter], [Smooth] or [Normal].
You can adjust the waveform position on the screen by adjusting the upper scale and lower scale. The IBP
waveform area provides the waveform scale. The top and bottom of each IBP waveform represent the upper
scale and lower scale respectively. You can set the upper scale and lower scale.The middle scale depends on
the upper scale and lower scale and it is not selectable.
1) Select [IBPx: XXX] in the waveform area to enter [IBPx: XXX Wave]. Select an appropriate range for
2) You can set the scale range for the pressure 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
Select [IBPx:] 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.
20-5
Chapter 21 Data Review
Select the [Review] soft key, or select [Main Menu] and then select [Review] to enter the review screen.
Data Review includes: NIBP Review, Alarm Event Review, Trend Graph Review, Trend Table Review,
Wave Review, 12-lead Report Review, and Patient Event Review.
The monitor provides 120h trend data, 2,000 sets of NIBP measurement data, 200 times of storage of
parameter alarm events, and at most 120h wave review of single-channel wave, up to 5 case reports for each
patient, 1,000 patient events, and up to 60 minutes of AED recording storage for each patient. This chapter
introduces the method to view these saved data in detail.
You can select the wave to be saved according to the requirements. 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 wave to be saved, and select [Enter]; operate according to the prompt message.
[Rec. Merge]: When admitting a new patient, the monitor creates a patient file, and save current
monitoring data to the patient file created.
[Rec. Not Merge]: When admitting a new patient, the monitor creates a patient file, but current
monitoring data is not saved to the patient file created.
Trend is a set of patient data over time shown 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 continuously shows the updated data. The bottom of the screen shows the time scale.
You can select the desired wave in the parameter area on the left side of the window; besides, you can browse
the trend database using 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:
21-1
Data Review
Cursor
Aperiodic measurements can be viewed from the trend table. This table shows measurement data and
measurement time. During a maximum period of 160h, the trend table data can be viewed.
Symbol Description
Symbol Introduction
Scroll the page up and down to view other parameter trend graphs not shown in the
current view.
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 starting point or the end point of the trend database to view the farthest
(earliest) or nearest (latest) trend info saved.
Select the date field beside [Start Time], and the setup window will pop up, where you can set the start
Trend Interval refers to the resolution of trend data shown on the screen. For neonate monitoring, since
21-2
Data Review
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. You can set the
Record time: Determine which period of trend data is to 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 within 30min will be printed. When [Forward Time] is set to
[Param.] (Parameter Selection): Select the specific parameter to be output in this menu.
This monitor displays the latest 2,000 sets of NIBP measurement data in [NIBP Review]. In the [Review]
menu, select [NIBP Review], as shown in the figure below:
21-3
Data Review
Record time: Determine which period of trend data is to be output by [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], NIBP list data during 1h will be recorded. When [Forward Time] is set to
Warning
Only current physiological and technical information is displayed. Once the monitor is restarted,
all the alarm information is cleared.
Alarm information in this window is not classified by patient.
When the alarm event storage reaches the maximum, the oldest alarm events are deleted.
The monitor can display the latest 200 parameter alarm events in [Alarm Event Review], including 200 times
physiological alarm events (including arrhythmia alarm events, and manual events). When an alarm event
occurs, the monitor saves the values of relevant parameters and the waveforms 8s before and after such
occurrence. There are three ways to enter the physiological alarm event review window, as described below:
1) Select the physiological alarm information area;
2) Or in the monitoring mode, press the [Review] softkey, select [Alarm Event Review] → [View
Physiology Alarm];
21-4
Data Review
3) Or enter the [Main Menu], select the [Review] menu, and then select [Alarm Event Review] → [View
Physiology Alarm];
See the figure below:
In [Event] under Alarm Review, you can select the alarm information of the parameter to be viewed.
Select to directly print current page alarm event data with recorder.
Select [View Technical Alarm] → [View Technical Alarm] menu. See the figure below:
Note
Technical alarm can only be viewed and cannot be printed.
21-5
Data Review
You can review full-disclosure waves only after the SD card is installed and waveform is set to be saved. The
monitor displays single-channel wave playback for a maximium of 120h in the [Wave Review] window. You
can review the waveform of any parameter of functions configured on the monitor:
Symbol Introduction
Operation Examples
ECG Wave Review:
1) Before admitting a patient, enter the [Wave Save] window 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 [Wave Review Report] menu. After setting the recorded start time in this menu,
select [Record] to record full-disclosure waveform for 6s.
21-6
Data Review
The 12-lead report review makes it easy to view all 12-lead ECG diagnostic reports, with up to 5 ECG
diagnostic reports per patient. There are two ways to enter the 12-lead report review window:
1) Press the [Review] softkey and select [12-lead Report Review];
2) Or go to [Main Menu], select the [Review] menu, and then select [12-lead Report Review].
Go to the 12-lead report review window, as shown in the figure below:
In the 12-lead report review, the diagnostic results are arranged in chronological order and a description of the
diagnostic results is listed. If you want to view more detailed diagnostic information, select a diagnosis result
and press the shuttle to view the corresponding diagnosis report, as shown in the figure below:
21-7
Data Review
3) Select [Record] under this interface to record the output diagnosis report.
The user enters the [Patient Event Review] interface to view 1,000 operation records, as shown in the figure
below:
21-8
Chapter 22 Record
The monitor uses a thermal arraycorder which supports several recording types and outputs the patient’s
information, measured data, reviews and at most 4 waves.
Recorder door
Latch lock
Attention
The four channels that record the waveform cannot select the same waveform at the same time.
Recordings are categorized into the following types according to the ways in which they are triggered:
Real-time recording triggered manually
Events: such as charging event, discharge event, marking event, 12-lead report, and automatic inspection
report
Review data
22-1
Record
To start recordings 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 recording function is enabled, the recorder starts 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
Open [Main Menu], and select [Record Setup] to enter relevant screen.
The recorder can print 4 waves at one time. In the recording output setup window, set Record Waves 1, 2, 3
and 4. These settings apply to real-time record and timed record.
2) Select a value.
1) In this menu, select [Rt Record Time] (Real-time Record Interval): select a value as needed.
If [8s] is selected, waves for 8s after the current moment are recorded.
22-2
Record
If [Continual] is selected, waves after the current moment are recorded; to stop the recording, use the
manual operation.
You can set the recording interval as needed; the setting of real-time record determines the time length
between two adjacent recordings.
1) In this menu, select [Timed Record Interval].
22.4.5 Grid
Select [Grid] and switch it between On and Off. When set it to On, the grid is printed out by the recorder on
the paper; when set to Off, the grid is not printed out on the paper.
Load the recorder 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 the paper carefully; otherwise the thermal print head may be damaged.
When the recorder is printing, do not pull the record paper with force; otherwise the recorder
may be damaged.
Do not keep the recorder door open except for paper change or troubleshooting.
22-3
Record
If the recorder makes any abnormal sound during running or the record paper outputs abnormally, check if
there is a paper jam. If yes, clear the jam according to the following steps:
1) Open the recorder door.
2) Take out the paper, and cut off the folded part.
After a long-term use of the recorder, scraps of paper and impurities could accumulate on the print head,
which affects the quality of recording and the service life of print head and roll shaft.
Cleaning procedures:
1) Before cleaning the recorder, prevent the equipment from being damaged by static electricity.
2) Open the recorder door; take out the paper, and use a cotton ball to dip an appropriate amount of alcohol.
4) When the alcohol becomes completely dry, reload the paper and close the recorder door.
Note
Do not use any materials (such as abrasive paper), that can damage the thermal part.
Do not squeeze the thermal print head with force.
22-4
Chapter 23 Other Functions
Wired connection:
1) Enter [User Maintain] → [Net Protocol] (Network Protocol).
3) Set [Net Bed] (Network Bed Number), [IP Address], [Gateway], [Server IP] and [Server Port]. Normally,
you only need to set Net Bed and leave other options to the default settings.
[Net Bed] is an identification number used by the monitor to communicate with the central
Note
Network bed number must be unique in the central monitoring system (CMS).
For details, see the User’s Instruction Manual for Central Monitoring System of our company.
After the monitor is connected to the central monitoring system, [Time Settings] turns to gray,
and you cannot make any operations.
The monitor allows user to format SD card. When [Format SD Card] is selected, all data is 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 restarts automatically.
Steps for formatting SD card:
1) Enter [User Maintain] → [Format SD Card]. A warning dialog [The monitor will auto restart after
formatting SD card! Confirm to format?] displays. Select [Enter] to format the SD card. The monitor
23-1
Other Functions
3 leads includes Off, I, and II; 5 leads includes Off, I, II, and V; 12 leads includes Off, I, II, V1, V2, V3, V4,
V5 and V6 (varying with the lead type selected). The monitor can be connected to an oscilloscope or other
external equipments via cables, and outputs analog signals such as lead I or lead II for use by such equipments.
Chapter 24 Battery
This monitor is equipped with twolithium rechargeable batteries with number ―1‖ and ―2‖ on the battery icon
to identify. The batteries will be charged automatically once the monitor is connected to the AC power supply,
no matter whether the monitor is turned on or turned off. Under the circumstance of sudden power failure, this
monitor will automatically operate onbatteries without any operation interruption. The battery indicator will
turn green after cutting off AC power supply.
When the battery is being charged, the battery bar is moving and the battery indicator turns yellow.
The battery bar displayed on the upper right corner of the screen indicates the battery’s charge level, here
taken battery 1 as an example:
There are multiple LEDs on the battery to indicate its approximate battery level. Press the button beside the
LEDs and the LEDs will be illuminated to show the battery level.
Warning
24-1
Battery
Note
If the battery is not to be used for a long period of time, please remove the battery and store it
properly according to the manufacturer’s instructions.
If the monitor is provided with a built-in battery, the battery must be charged after each use to
ensure sufficient charge.
As the battery is used and aged, the remaining battery power displayed by the battery icon may
deviate from the actual power. Please refer to the system alarm information.
If battery power is used, when the battery is low, the instrument will report the ―Low Battery‖ alarm. In this
case, the battery shall be replaced or AC power shall be inserted in time to avoid affecting the patient's
treatment and monitoring. When the battery is seriously depleted, the instrument triggers an alarm and shuts
down the countdown. In this case, plug in the AC or replace the battery immediately.
Note
After the alarm ―Low Battery‖ is triggered, this monitor can at least conduct vital signs
monitoring for 20 minutes and 6 maximum energy deliveries. The battery shall be replaced or
AC power shall be connected immediately.
If the operation time of battery is obviously shorter than the time declared in battery specification, the system
will trigger a technical alarm ―Battery 1(2) Aging‖. Under such circumstance, contact the manufacturer to
replace the battery.
When there is any battery fault, the system will trigger a technical alarm ―Battery 1(2) Fault‖.Under such
circumstance, replace battery or contact the maintenance personnel.
Battery
1) Turn off the monitor and disconnect power cord and other connecting cables.
4) Press the battery into the battery pin until it clicks into place.
5) To replace a battery, press the latch on the right end of the battery with right hand and push the battery to
Warning
Only the battery specified by the manufacturer can be used.
The installation of the battery should be performed by the personnel authorized by the
manufacturer.
Watch your hand when installing the battery.
Do not remove the battery when the equipment is working.
2) Put the battery for conditioning in the battery compartment of the equipmentequipment.
3) When charging the battery, please ensure that the battery is charged uninterruptedly until it is fully
charged.
4) Disconnect AC power supply, and use the battery to supply power to the monitor until the monitor shuts
down automatically.
1) Determine whether the battery is damaged. When the battery icon shows , it indicates the battery
Battery
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.
4) When charging the battery, 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 power to the monitor until the monitor shuts
down automatically; meanwhile note down the start time and end time of discharging.
7) When the discharging time reduces to less than 50% of the initial time, replace the battery.
Note
In order to prolong the service life of the rechargeable battery, if the battery is to be stored for
a long period of time, it is suggested that the battery is charged every three months to prevent
excessive discharging.
The power supply time of the battery depends on the configuration and operation of the
equipment. For example, frequent NIBP measurement reduces the power supply time of the
battery.
If the battery is obviously damaged or runs out, it should be replaced. Dispose of batteries 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 the battery may
cause fire, explosion, leakage of hazardous gas or other hazards.
Chapter 25 Cleaning and Disinfection
Only materials and methods listed in this chapter that are approved by the company can be used for cleaning
or disinfection of the equipment. For any damage arising from use of unaccepted materials or methods, the
warranty does not cover. This chapter describes how to clean and disinfect the monitor and some accessories.
The cleaning and disinfection methods for the remaining accessories are detailed in the corresponding
accompanying documents.
The company does not assume any liability for the effectiveness of listed chemicals or methods when they are
used as infection control means. For infection control methods, consult the Infection Prevention Department
or an epidemiologist in your hospital. Besides, refer to local policies that apply to your hospital and country.
25.1 Overview
Keep the equipment and its accessories dustless. After cleaning, check the equipment carefully. If there is any
evidence of ageing or damage, stop using it immediately. If it is necessary to send the monitor back to our
company for repair, send us a clean monitor. Observe the following precautions:
Before cleaning the device, you must turn off the power, remove the battery, and disconnect the power
Dilute the detergent and disinfectant as specified by the manufacturer, or use a concentration as low as
possible.
Do not pour any liquid onto any part or accessory of the equipment.
Do not use any abrasive or corrosive material, bleaching powder or strong solvent (for example, acetone
Keep the electrode paddle clean. The electrode paddle and the electrode base shall be thoroughly cleaned
25-1
Cleaning and Disinfection
Warning
Only use detergents and disinfectants recommended in this manual. Using other detergents and
disinfectants may result in damage to the equipment or other risks.
Before cleaning the monitor, power it off and disconnect it from the AC power supply.
Do not use EtO (ethylene oxide) to disinfect the monitor.
Do not leave any disinfectant residue on the surface and accessory of the monitor.Use a wet cloth
to clean it immediately.
It is not allowed to use detergent mixture; otherwise hazardous gases maygenerate.
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 disposed of properly.
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.
Do not use any cleaning solution not recommended in this manual; failure to do so may result in
permanent damage to the equipment, sensor or cable.
Do not 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.
Do not soak the ISA sidestream gas analyzer in any liquid for disinfection.
The Nomoline sampling line is not a sterile equipment. In order to avoid damage, do not sterilize
any part of the sampling line under high pressure.
Caution
If you carelessly pour any liquid onto the equipment or any accessory, contact the maintenance
personnel or our Company immediately.
The monitor and modules 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. Before cleaning, first consult or understand relevant rules of your
hospital on equipment cleaning. Water, hydrogen peroxide (diluted concentration), alcohol (diluted
concentration), isopropanol (diluted concentration), and sodium hypochlorite solution (diluted aqueous
solution) are recommended by our company.
Cleaning steps:
1) Power the equipment off, and unplug the power cord, accessories and batteries.
Cleaning and Disinfection
2) Use a soft cloth dipped with an appropriate amount of detergent to wipe the housing of the monitor and
modules.
3) Use a soft cloth dipped with an appropriate amount of detergent to wipe the display screen of the monitor.
4) If necessary, you can use a soft, dry cloth to remove residual detergent.
5) Put the monitor and modules in a cool, well-ventilated environment to air-dry it.
It is suggested that the monitor and modules can be disinfected only when it is considered necessary in the
maintenance plan of your hospital. Before disinfection, clean the monitor and modules first. 70% alcohol, 70%
isopropanol, 2% glutaraldehyde, 3% hydrogen peroxide and 0.5% sodium hypochlorite solution are
recommended by our company.
It is suggested that the accessories can be disinfected only when it is considered necessary in the maintenance
plan of your hospital. Before disinfection, clean the accessories first.
Warning
Do not use a chlorine-containing disinfectant such as sodium hypochlorite solution, bleach, or
chlorhexidine gluconate to wipe the metal parts of the defibrillation electrode paddle. Chlorine
disinfectants and or other oxidizing disinfectants can corrode the electrode paddles.
Our recommended external electrode paddle cleaners are: water, alcohol (diluted concentration), and
isopropyl alcohol (diluted concentration); disinfectants are: 70% alcohol, 70% isopropanol, and 2%
glutaraldehyde. Check carefully before cleaning and disinfection. If the external electrode paddle is damaged,
it shall not be used any more.
The specific method is as follows:
1) Soak a soft cloth in a detergent or disinfectant (no water can be squeezed out), and wipe the defibrillation
3) If necessary, you can use a soft, dry cloth to remove residual detergent.
5) The two defibrillation electrodes shall be separately wrapped to prevent damage to the electrode surface.
Our recommended internal electrode paddle cleaners are: water, alcohol (diluted concentration), and isopropyl
alcohol (diluted concentration). Disinfectants are: 70% alcohol, 70% isopropanol, and 2% glutaraldehyde.
Check carefully before cleaning and disinfection. If the internal electrode paddle is damaged, it shall not be
used any more.
The method of cleaning and disinfection by wiping:
1) Soak a soft cloth in a detergent or disinfectant (no water can be squeezed out), and wipe the defibrillation
2) If necessary, you can use a soft, dry cloth to remove residual detergent.
4) The two defibrillation electrodes shall be separately wrapped to prevent damage to the electrode surface.
The method of high-temperature disinfection:
High-pressure steam: Adjust the presswure of the high-pressure steam equipment to 130Kpa and the
temperature to 135 degrees Celsius. The disinfection time is 5 minutes.
Caution
Use only the detergents and disinfectants specified in the Manual.
Do not immerse the internal electrode paddle in detergent for cleaning.
The internal electrode paddle can only be cleaned by hand, not by ultrasonic or mechanical
means.
Our recommended NIBP cuff cleaners are: Water, hydrogen peroxide (diluted concentration), alcohol (diluted
concentration), isopropanol (diluted concentration), and sodium hypochlorite solution (diluted aqueous
solution); disinfectants are: 70% alcohol, 70% isopropanol, 2% glutaraldehyde, 3% hydrogen peroxide and
0.5% sodium hypochlorite solution.
Before cleaning the cuff, remove the rubber bag.
The cuff can be washed by machine or hand with warm water and mild detergent. Hand wash can prolong its
service time. The rubber bag can be cleaned using a wet cloth dipped with clean water. Naturally air-dry it
after cleaning.
The cuff can be disinfected using a wet cloth dipped with disinfection. Long-term use of disinfectants may
result in color fading or discoloration of the cuff.
Cleaning and Disinfection
Warning
Do not squeeze the rubber tube on the cuff.
During cleaning, only wipe the external surface of the connector. Do not wipe its inner surface.
Carefully clean the rubber bag. Do not allow any liquid to flow into the rubber bag.
Do not dry-clean the cuff.
The disposable cuff can be cleaned with soap to control infection.
After cleaning, put the rubber bag into the cuff according to the following steps:
SpO2 probe
ECG cable
TEMP probe
70% alcohol, 70% isopropanol, 2% glutaraldehyde, 3% hydrogen
IBP cable, analog SpO2 main cable, peroxide and 0.5% sodium hypochlorite solution
and CO2 extension cable
SpO2 probe
A comprehensive maintenance check including safety check should be conducted by the qualified
maintenance personnel before using, after 6-12 continuous operation or after each maintenance and upgrading.
Check items including:
Self-test
Shift exchange check
User test
Recorder test
Manual defibrillation test
Pacing test
Functional module test
NIBP overpressure protection test
Electrical safety test
Cables and paddles which can be abraded easily are key accessories for this defibrillator/monitor. Daily
inspection and test is recommended.
If you find any damage on the defibrillator/monitor, stop using it on patient,and contact the biomedical
engineer of the hospital or our customer service immediately.
All the safety and maintenance checks that need to dismantle the monitor should be performed by a qualified
customer service technician. Non-professional operation can cause the monitor damage or cause a security
risk, and human health may be endangered.
The circuit diagrams of the defibrillator/monitor can be provided by Comenas per customer demands.
Qualified technicians can use it to help the user repair some apparatus that our company classifies as ―can be
maintained by the user‖.
Warning
If the hospital or agency who uses thisdefibrillator/monitor does not follow a satisfactory
maintenance schedule, the defibrillator/monitor may become damaged and personal safety may
be endangered.
The following maintenance and test items can only be conducted by the maintenance personnel approved by
our company. Please clean and disinfect this defibrillator/monitor before maintenance and test.
Maintenance and test items Schedule
Clean this equipment and accessories After use
26-1
Maintenance
26.3 Self-test
Each time you turn on the defibrillator/monitor, it performs internal self-test. If any error is found during self-
test, service indicator will be illuminated and alarm message will be displayed in technical alarm message area.
Self-test contains the following test items:
Power module test
Therapy module test
Maintenance
Self-test should be performed every day or after initial installation and replacing components for the main unit
to make sure that the defibrillator/monitor can work properly.
Specific steps are as follows:
1. Put paddles into the paddle tray and make them contact well. Install the defibrillator/monitor with battery
(install two batteries if equipped) and connect AC power supply. Check whether AC indicator and battery
indicator are illuminated.
2. Rotate mode selector to monitor mode. Check whether the defibrillator/monitor can be turned on.
3. Observe technical alarm message area, physiological message area and battery icon for error message.
In order to ensure that your defibrillator/monitor is available at any time, it is recommended to perform checks
according to the ―Shift Exchange Checklist‖ in Appendix.
As long as the defibrillator/monitor is connected to AC power supply, it will perform routine test and energy
delivery test daily at the specified time and remind the users of the error found.
How to set auto test time:
1. Access [Main Menu]→[Config Manage]→enter password
2. Select [Detection Setup]→[Auto Test Time] and select auto test time. Available options include 0:00,
1:00, 2:00, 3:00, 4:00 and 5:00.
Auto test item and schedule are listed below:
Test item Description Schedule
Routine test Test battery and therapy modules Once a day from 0:00 to 5:00
Energy delivery test Deliver 200J energy Once a week after routine test.
There is no prompt message on the screen of defibrillator/monitor during auto test. If auto test fails, the
maintenance indicator will flash and the buzzer will continue to sound at regular intervals until it is turned
back on. After turning on the defibrillator/monitor, a low level technical alarm ―Last Auto Test Failed‖ will be
triggered. If the next auto test passes, or the routine test or energy delivery test which fails in auto test passes
during user test, the ―Last Auto Test Failed‖ alarm will be cleared.
It is recommended to perform user test if the auto test fails.
The defibrillator/monitor will save an auto test report after each auto test. You can choose whether to print
auto test report after each auto test. Specific steps are:
1. Access [MainMenu]→[Config Manage]→enter password.
2. Select [Record Setup]→[Auto Record] →[Auto Check Report] and select [On] or [Off].
You can select [History] in user test interface to view the auto test results.
Attention
If the defibrillator/monitor is switched off, it will perform auto test daily at the specified time
only when it is connected to AC power supply.
Install the defibrillator/monitor with at least one battery, place the paddles in the paddle tray
Maintenance
correctly or connect electrode cable and 50Ω test load, or the auto test will not pass.
Clean the paddles and place them into paddle tray correctly after each use. Only when the
paddles contact well with the metal parts of paddle tray, will the auto test pass.
User test performs routine test, energy delivery test and controls test.
Warning
Make sure that patient is not connected to the defibrillator/monitor when conducting user test.
Attention
Install the defibrillator/monitor with at least one battery, place the paddles in the paddle tray
correctly or connect electrode cable and 50Ω test load, or the auto test will not pass.
Clean the paddles and place them into paddle tray correctly after each use. Only when the
paddles contact well with the metal parts of paddle tray, will the auto test pass.
Select items to be tested and select [Start] to start test. Perform the test following what indicated on the screen.
After test, the ―Test completed‖ prompt message will be displayed. Press [Record] to print the test result.
Press [Back] soft button to return to user test interface.
Attention
It is recommended to perform user test when changing shift.
Energy delivery test includes 200J charge and shock test and charge and shock circuit function test. Perform
the energy delivery test following what indicated on the screen.
If energy delivery test fails, the service indicator will be illuminated and the system will give low level
technical alarm ―Last User Test Failed‖ when switching on the defibrillator/monitor next time. It is suggested
to perform a successful user test to clear this alarm.
Attention
During controls test, the controls have been tested turn green.
Controls test doesn’t test the OFF mode. If you rotate the mode selector to OFF for more than
2s, the defibrillator/monitor will shut down.
The defibrillator/monitor could save the test results of routine test, energy delivery test and controls test. Press
[History] in user test interface to view the test results.
The defibrillator/monitor could save up to 300 test reports which are listed in chronological order. Select a
certain test report to view it in detail. Select [Record] to record this test report.
Press [Pre Page] and [Next Page] to view the test reports not on current page. Press [Delete All] to delete all
the test reports. Press [Back] soft button to return to user test interface.
It is recommended to perform routine test and energy delivery test once a week and controls test once a year.
Each time you turn on the defibrillator/monitor, the system will check the time period from last routine test,
energy delivery test and controls test automatically. If user test prompt function is activated and you do not
perform corresponding test within the suggested time period, the system will give technical alarm ―User Test
Due‖. If user test prompt function is deactivated and there will be no prompt even when user test is overdue.
How to activate or deactivate user test prompt function:
1. Access [Main Menu]→[Config Manage]→enter password
2. Select [Detection Setup]→[User Test Prompt] and select [On] or [Off].
Maintenance
1. Remove two batteries, connect the defibrillator/monitor to AC power supply only, switch on the
defibrillator/monitor and switch to manual defibrillation mode.
2. Connect paddle cable with the therapy cable connector on the defibrillator/monitor. Place the paddles on
the defibrillator/pacer analyzer correctly.
3. Access [Config Manage]→ [Record Setup]→[Auto Record] and set [Charge Event] and [Shock Enevt]to
[ON].
4. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy is 0 or blank this moment).
5. Select 1J energy for the defibrillator/monitor.
6. Charge the defibrillator and deliver the energy to verify whether the value measured by the
defibrillator/pacer analyzer meets the accuracy requirements shown in the following table.
Energy select (J) Measured value (J)
1 0~3
100 85~115
360 306~414
7. Adjust energy level to 100J and 360J respectively and repeat step 6.
Maintenance
8. Operate the defibrillator/monitor on fully charged battery, switch on it and switch to manual defibrillation
mode. Repeat step2 through step 7.
9. Check whether the charge/shock event has been recorded automatically and what has been recorded is
correct.
10. Use the pads and repeat step 3 through step 9.
1. Operate the defibrillator/monitor on fully charged battery, switch it onand switch to manual defibrillation
mode.
2. Connect paddle cable with the therapy cable connector on defibrillator/monitor. Place paddles on the
defibrillator/pacer analyzer correctly.
3. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy should be 0 or blank at this moment).
4. Select 360J energy for the defibrillator/monitor.
5. Charge the defibrillator/monitor.
6. Check whether there is charge tone during charge.
7. After charge, press [Disarm] soft button to disarm the energy.
8. Check there is ―Charge Removed‖ prompt message and the charge completed prompt tone stops.
9. Check that the measured energy value on defibrillator/pacer analyzer is 0J or blank.
10. Access [Config Manage]→[Manul Def Setup]and set [Auto Disarm Time] to 60s.
11. Exit [CONFIG SETUP] menu.
12. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy should be 0 or blank at this moment). Select 360J energy for the defibrillator/monitor and charge.
13. Form the moment charge completes, check whether there is ―SHOCK CANCELED‖ prompt message
after 60s and whether the measured energy value on defibrillator/pacer analyzer is 0J or blank.
14. Use pads and repeat step3 through step 12.
1. Connect paddle cable with the therapy cable connector on defibrillator/monitor. Place paddles on the
defibrillator/pacer analyzer correctly. Connect ECG cable with the defibrillator/monitor and connect the
lead wires to the defibrillator/pacer analyzer.
2. Set the operating mode of defibrillator/pacer analyzer as synchronized defibrillation time measurement
mode and output normal sinus rhythm (for example: amplitude 1mV, heart rate 60bpm).
3. Access [Config Manage]→[Manul Def Setup]and set [Sync Keep] to [On].
4. Select 10J for the defibrillator/monitor.
5. Press [Enter Sync] soft button to enter synchronized defibrillation mode. If remote synchronization input
function is activated, after pressing [Enter Sync] soft button, select [Local] in the pop-up dialog box to
enter synchronized defibrillation mode.
6. Press LEAD SELECT button on the front panel to select [Pads] as ECG source and charge the
defibrillator.
7. After charge, press both shock buttons on paddles to deliver the energy synchronously.
8. Check whether the system can deliver the energy synchronously. The delivered energy measured by the
defibrillator/pacer analyzer should meet the requirement of 10J±2J.
9. Check that the delay of defibrillation synchronization measured by the defibrillator/pacer analyzer is less
Maintenance
than 60ms.
10. Check that the synchronized shock marker is above R wave.
11. Check that the prompt messages are correct during the test.
12. Select lead II as ECG source. Charge the defibrillator and repeat step 7 through step 11.
13. Use pads and repeat step 2 through step 12.
During the use of monitor, ECG calibration is required when the ECG signal is inaccurate. ECG calibration
should be conducted by the serviceman approved by our company at least once a year or when you doubt the
measured value.
Specific steps are as follows:
1. Enter [Main Menu]→[Maintain]→[User Maintain]→enter password →[ECG Calibrate].Then the screen
displays square wave signal and displays prompt message ―Cal...can't monitor!‖.
2. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
3. After calibrating, press [Stop ECG Cal].
The NIBP Leakage Test 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 does not give any
prompt; if not, a corresponding error message is shown in the NIBP info area.
Gas Leakage Test Process:
1) Properly connect the cuff to the NIBP opening in the monitor.
2) Wrap the cuff around a cylinder of proper size.
3) Enter [Main Menu] →[Maintain]→[User Maintain]→ [Leakage Test].
Maintenance
4) At this moment, [Leakage Testing] is shown in the lower part of the NIBP parameter area on the screen,
indicating that the system started performing the air leakage test.
5) The system inflates the cuff automatically until the pressure reaches 180mmHg.
6) About 20s later, the system turns on the deflation valve automatically, indicating that leakage
measurement is finished.
If no prompt message is shown in the NIBP parameter area, it indicates the system has no leakage. If
[Pneumatic Leak...] is shown, it indicates the air 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 leakage test again. If there is still any fault prompt, contact the manufacturer for repair.
Cylinder
Monitor
Tube
Cuff
Warning
This leakage test is different from those described in EN 1060-1. This is simply for the user to
test whether there is air leakage during NIBP inflation. If the system shows NIBP air leakage at
the end of the test, contact service techinician of our company.
Warning
Calibration of NIBP measurement should be performed once every two years (or according to
maintenance rules of your hospital). Check its performance according to the following details.
NIBP pressure verification should be carried out once a year or when you doubt the measured NIBP by the
serviceman approved by our company.
Manufacturers recommend a calibrated pressure gauge (or mercury sphygmomanometers) with a precision
more than 1mmHg to be used for NIBP pressure verification. Specific steps are as follows:
1. Set measure mode to adult mode and select a metal container with a volume of 500ml ± 5% to replace
cuff.
2. Connect a calibrated standard gauge with measurement error of less than 1mmHg, a spherical air pumps
with a t-interface and inflatable tubes with NIBP socket on the monitor as the figure shown below:
Maintenance
It is recommended to conduct NIBP overpressure protection test once a year. The specific steps are as follows:
1. Open the housing of the defibrillator/monitor, take out the multi-parameter module, remove the gas tube
connected with NIBP measuring transducer and block it up.
2. Connect NIBP cuff.
3. Start NIBP measurement. When the pressure rises to the overpressure protection point (300~330mmHg),
the valve will open and the sound of deflation will be heard, and the prompt message ―Over Pressure‖
will be displayed on the screen.
If the system can give an alarm and deflate normally, the overpressure protection function is normal.
Otherwise, please contact the service technician of our company.
IBP calibration can only be performed by the manufacturer at least once a year or as required. When IBP
calibration is needed, please contact the manufacturer.
The users can not conduct the electric safety test including ground impedance test, leakage current test and so
on. Please contact the service technician for the electric safety test when necessary.
Appendix I Accessories
Warning
Please use the accessory models specified by the manufacturer. Using other models of
accessories may damage the monitor or affect performance.
Disposable accessories can only be used once. Repeated use may result in reduced performance
or cross-infection.
Please check the packaging of the accessories before using the accessories. Do not use the
accessory if it is found to be damaged or not.
Expired and damaged accessories may cause environmental pollution and must be disposed of
in accordance with relevant local laws and regulations or hospital systems.
When using accessories, refer to the accessory manual, and consider the requirements for
operating environment of accessories.
Defibrillation accessories
Accessory Patient type Model Part No.
External paddles Adult, pediatric CM3901 040-000660-00
Pads Adult DF20N 040-000665-00
pediatric DF31L 040-000666-00
Pads cable / CM3905 040-000664-00
ECG accessories
Accessory Lead type Compatible Type Model Part No.
with
ECG lead wire 12-lead AHA Clip 98ME01AB076 040-000481-00
12-lead IEC 98ME01EB075 040-000487-00
5-lead AHA 98ME01AC457 040-000480-00
5-lead IEC 98ME01EC680 040-000486-00
3-lead AHA 98ME01AC458 040-000479-00
3-lead IEC 98ME01EC681 040-000485-00
SpO2 accessories
Accessory Patient type Type Model Part No.
SpO2 sensor Adult Reusable, finger DS-100A 040-000010-00
Adult Reusable, finger DURA-Y®D-YS 040-000075-00
Pediatric Reusable, finger OXI-P/I 040-000086-00
Neonate Reusable, foot OXIBAND®OXI-
040-000087-00
Adult Reusable, finger A/N
Pediatric Disposable, finger MAX-P 040-000004-00
I-1
Accessories
I-2
Accessories
I-3
Accessories
I-4
Appendix II Product Specifications
1) Monitor Type
Item Classification
Type of protection against electrical I class, CF and BF applied parts with defibrillator-
shock proof protection
Type of medical apparatus and IIb class
instruments management
Degree of protection against harmful IPX4
ingress of water
Degree of protection against harmful IP4X
ingress of solid particle
Safety degree of use in the environment This defibrillator/monitor cannot be used in the
with flammable anesthesia gas or nitrous environment with flammable anesthesia gas or nitrous
oxide (Not applicable) oxide
Operating mode Continuous
2) General Specifications
2.1 Dimension and Weight
Item Specifications
Size and Size:324mm(L)×220mm(W)×345mm(H)(Including external paddles)
weight Size:301mm(L)×220mm(W)×345mm(H)(Not including external paddles)
Weight: 7.5Kg (not including batteries)
Weight of one battery: 0.7Kg
II-1
Product Specifications
2.3 Display
Item Specifications
Screen size 8.4 inch color TFT display screen
Displayed Up to 2 waveforms can be displayed.
information
Resolution 800×600 pixels
2.5 Battery
Item Specifications
Battery Two rechargeable lithium-ion battery 4500mAh, 14.8V
Charge time Charge time to 80% charge level in less than 2 hours; charge time to 100%
charge level in less than 3 hours
Running time Running time of one battery in the environmental temperature of 20℃ is as
follows: (Running time of two batteries is twice of that of one battery)
Monitoring mode: more than 5 hours(interval of NIBP measurement is 15
minute and no printing);
Defibrillation mode: more than 100 discharges(maximum energy level,
charge interval more than 1 minute and no printing)
Pacing mode: more than 2 hours (50Ω load, frequency 80bpm, current
60mA and no printing)
Battery There is multiple LEDs on the battery to indicate its approximate charge
capacity
indicator
Low battery After low battery alarm, 20 minutes vital sign monitoring and at least 6
alarm maximum energy discharges can be conducted at the same time.
II-2
Product Specifications
Energy select
External defibrillation 1/2/3/4/5/6/7/8/9/10/15/20/30/50/70/100/120/150/170/200/220/250/2
70/300/360J
Internal defibrillation 1/2/3/4/5/6/7/8/9/10/15/20/30/50J
Charge time
Powered by new fully Charge time to 200J in less than 5s; charge time to 360J in less than 8s
charged battery(with 20℃
environmental
temperature)
Powered by AC power Charge time to 200J in less than 7s; charge time to 360J in less than
supply 11s
AED
Serial shock Shock energy: 100~360J
Shock times: 1, 2,3
Shockable rhythm VF, VT (heart rate >150bpm and QRS width >120ms)
II-3
Product Specifications
360J defibrillation waveform (load impedance is 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω and 175Ω,
respectively)
17
15
12
10
75
50
25
Ω
Energy accuracy
Impedance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accur
Energy acy
1J 1 1 1.1 1 1 0.9 0.8 2J
2J 2 2 2 2 2 1.8 1.8 2J
3J 2.8 3 3 2.8 3 2.7 2.5 2J
4J 3.8 4 4.1 3.8 4 3.6 3.5 2J
5J 4.8 5 5.0 4.8 4 4.5 4.2 2J
6J 5.8 6 5.9 5.9 5 5.4 5.3 2J
7J 6.8 7 6.9 6.9 6.8 6.3 6.0 2J
8J 7.8 8 8 8.0 7.5 7.2 7.0 2J
9J 8.8 9 9 8.6 8.5 8.1 7.7 2J
10J 9.6 10 9.9 9.6 9.3 9.0 8.4 2J
15J 15 15 15 14 14 13 13 15%
20J 19 20 20 19 18 17 17 15%
30J 29 30 30 29 27 26 25 15%
50J 49 50 49 48 45 44 42 15%
70J 68 70 69 66 63 60 58 15%
II-4
Product Specifications
II-5
Product Specifications
II-6
Product Specifications
II-7
Product Specifications
II-8
Product Specifications
Electrotome protection Cut mode: 300W; coagulation mode: 100W, recovery time:≤10s
HR calculation
Pacing pulse
Pacing marker There will be pacing marker for the pacing pulse that meets the
following conditions:
Amplitude: ±2~±700mV
Width: 0.1~2ms
Uprising time: 10~100μs
Pacing inhibition Comply with requirements of IEC60601-2-27, and suppress pulses that
meet the following conditions:
Amplitude: ±2~±700mV
Width: 0.1~2ms
Uprising time: 10~100μs
Minimum input slew rate: 10V/s RTI
II-9
Product Specifications
II-10
Product Specifications
II-11
Product Specifications
II-12
Product Specifications
accuracy in human blood studies on healthy adult male and female volunteers with light to darkskin
pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at
an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at anamplitude of 2 to 3 cm in
induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG
monitor. This variation equals ±1 standard deviation. Plus orminus one standard deviation encompasses
68% of the population. 1% has been added to the results to account for the effects of fetal hemoglobin
present in neonates.
5 The Masimo SET technology with Masimo sensors has been validated for pulse rate accuracy for the
range of 25 -240 bpm in bench top testing against a Biotek Index 2™ simulator. Thisvariation equals ±1
standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
6 Sensor accuracy specified when used with Masimo technology using a Masimo patient cable for LNOP
sensors, RD SET sensors, the LNCS sensors, or the M-LNCS sensors. Numbersrepresent Arms (RMS
error compared to the reference). Because pulse oximeter measurements are statistically distributed, only
about two-thirds of the measurements can be expected to fallwithin a range of ± Arms compared to the
reference value. Unless otherwise noted, SpO2 accuracy is specified from 70% to 100%. Pulse Rate
accuracy is specified from 25 to 240 bpm.
7 Masimo M-LNCS, LNOP, RD SET, and LNCS sensors types have the same optical and electrical
properties and may differ only in application type (adhesive/non-adhesive/hook & loop), cablelengths,
optical component locations (top or bottom of sensor as aligned with cable), adhesive material type/size,
and connector type (LNOP 8 pin modular plug, RD 15 pin modular plug, LNCS9 pin, cable based, and
M-LNCS 15 pin, cable based). All sensor accuracy information and sensor application instructions are
provided with the associated sensor directions for use.
2.13 PR Specifications
Item Specifications
Measurement range (1) Standard SpO2 module
and error Measurement range: 20bpm~254bpm; resolution: 1bpm; error: ±1bpm
(2) Masimo SpO2 module
Measurement range: 25bpm~240bpm; resolution: 1bpm; error: ±3bpm
(without motion) and ±5bpm (with motion)
(3) Nellcor SpO2 module
Measurement range: 20bpm~300bpm; resolution: 1bpm; error: ±3bpm in the
range of 20bpm~250bpm, no specified in the range of 251bom~300bpm
Upper limit: (lower limit +1)~350bmp
Alarm limits and
Lower limit: 0~(upper limit -1) bpm
accuracy
±1 bpm
II-13
Product Specifications
error ±0.1℃
Display resolution 0.1C
Number of channels Two channels
II-14
Product Specifications
II-15
Appendix III Cardiac Rhythm Recognition Test
According to the requirements of the standard IEC60601-2-4 and AAMI DF80, the algorithm evaluation
indicators mainly include sensitivity and specificity. The calculation is as follows:
A
Sensitivity
AC
D
Specificity
BD
Where: A - true positive, B - false positive, C - false negative, D - true negative
The number of evaluation samples and indicator requirements are shown in the following table:
Rhythm Minimum test sample Result
Shockable
Coarse VF,Fine VF 250 >90% sensitivity
Shockable VT 50 >75% sensitivity
Nonshockable 300 total
NSR 100(arbitrary) >99% specificity
AF, SB, SVT, heart block, 30(arbitrary) >95% specificity
idioventrivular, PVCS, etc.
Asystole 100(for safety) >95% specificity
Unshockable VT 25 Report only
Refer to the AHA recommendations: Automatic External Defibrillators for Public Access Defibrillation:
Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating
New Waveforms, and Enhancing Safety);
ECG test database
The database used for evaluation mainly includes:
MIT-BIT Malignant Ventricular Arrhythmia Database (VFDB)。
The American Heart Association Electrocardiographic Database (AHADB) (ANSI/AAMI EC57 standard
requirements).
MIT-BIT arrhythmia Database (MITDB)(ANSI/AAMI EC57 standard requirements).
Creighton University Ventricular Tachyarrhythmia Database (CUDB) (ANSI/AAMI EC57 standard
requirements).
The three results of the sample test are evaluated as the criteria for eligibility. See the following table
for details:
Test conclusion
Rhythm Minimum test Actual test Result Standard
sample sample
Coarse VF,Fine VF 250 300 93.6% >90%
III-1
Cardiac Rhythm Recognition Test
III-2
Appendix IV System Alarm Information
Some of the most important physiological and technical alarm messages are listed in this section, and some of
the alarm information may not be listed.
XX stands for: certain module names and physiological parameters in the HR, ST, RR, TEMP (including
TEMP1, TEMP2, and TD), SpO2, PR, CO2 (including AwRR, INS, and Fi), NIBP, IBP and other systems.
The corresponding countermeasures are listed for the alarm information. After following the countermeasures,
if the problem persists, please contact your service representative.
Among which, technical alarm category classification: A means that it can be completely cleared, B means
that the sound and light can be cleared, and C means that it cannot be cleared.
And the level of technical alarms is not adjustable after leaving the factory (except ECG and SpO2).
(1) Physiological alarm
Source Default Adjustable level Cause Countermeasures
level
ECG
High-level,
Medium-
XX too high medium-level, and
level
low-level
High-level,
Medium-
XX too low medium-level, and
level
low-level
The value of
Among which, XX stands for ST, ST-I, ST-II, ST-III,
the measured
ST-aVR, ST-aVL, ST-aVF, ST-V, ST-V1, ST-V2, Check the patient's
parameter is
ST-V3, ST-V4, ST-V5, and ST-V6. physiological condition, and
above the
Medium- High-level, and confirm if the patient type and
HR too high upper alarm
level medium-level alarm limit settings are
limit or below
Medium- High-level, and appropriate for the patient.
HR too low the lower
level medium-level
alarm limit.
High-level,
Medium-
PVCs too high medium-level, and
level
low-level
High-level,
Medium-
PVCs too low medium-level, and
level
low-level
The patient's
Check the patient's condition,
ECG Lost for
ECG Lost Low-level Low-level electrodes, cables and lead
the system to
wires.
analyze.
ECG Noise Low-level Low-level
Medium- High-level, and The patient Check the patient's
Heart Pause has condition, electrodes, cables
level medium-level
Medium- High-level, and arrhythmia. and lead wires.
Vent.Rhythm
level medium-level
IV-1
System Alarm Information
SpO2
IV-2
System Alarm Information
IV-3
System Alarm Information
TEMP
Medium- High-level, medium-
T1 too high The value of
level level, and low-level
the measured
Medium- High-level, medium-
T1 too low parameter is Check the patient's
level level, and low-level
above the physiological condition, and
Medium- High-level, medium-
T2 too high upper alarm confirm if the patient type and
level level, and low-level
limit or alarm limit settings are
Medium- High-level, medium-
T2 too low below the appropriate for the patient.
level level, and low-level
lower alarm
Medium- High-level, medium-
TD too high limit.
level level, and low-level
CO2
Medium-
CO2 too high Not adjustable
level
The value of
Medium-
CO2 too low Not adjustable the measured
level
parameter is Check the patient's
Medium- High-level, medium-
AwRR too high above the physiological condition, and
level level, and low-level
upper alarm confirm if the patient type and
Medium- High-level, medium-
AwRR too low limit or alarm limit settings are
level level, and low-level
below the appropriate for the patient.
Medium- High-level, and
INS too high lower alarm
level medium-level
limit.
Medium- High-level, and
INS too low
level medium-level
IV-5
System Alarm Information
IV-6
System Alarm Information
SpO2 Module
C Module failure Return to the
Error Low
manufacturer for repair.
(masimo)
TEMP1
Low A The TEMP sensor
Sensor Off Check the connection of
TEMP is not connected
TEMP2 the TEMP sensor.
Low A well.
Sensor Off
NIBP Selftest NIBP initialization Select the reset function in
High A
Err. error the NIBP menu. If the
NIBP error persists, please
NIBP Comm
High A communication part contact the manufacturer
Error
has a problem. for repair.
NIBP cuff is not Please reconnect the NIBP
Loose Cuff Low A
connected well. cuff.
There is gas leakage
Pneumatic
Low A at the NIBP gas
Leak
circuit.
A problem occurs
during the
measurement of
curves, and the
Pressure
Low A system is unable to
Overrange
conduct
measurement
NIBP analysis and Check the connection of
calculation. each part or update a cuff.
NIBP cuff is not If the fault persists, please
connected well, or contact the manufacturer
Air Leak Low A
there is gas leakage for repair.
at the gas circuit.
A problem occurs
during the
measurement of
curves, and the
Air Pressure
Low A system is unable to
Error
conduct
measurement
analysis and
calculation.
A problem occurs Check if the patient type
Weak Signal Low A during the setting is correct, and
measurement of check the connection of
IV-7
System Alarm Information
IV-8
System Alarm Information
Batteries 1 and 2
No Battery Low A Please install the battery.
are not installed.
Battery 1 is not
No Battery 1 Low A Please install the battery 1.
installed.
Battery 2 is not
No Battery 2 Low A Please install the battery 2.
installed.
Please replace the battery. If
the problem persists, please
Battery failure or
Battery 1 contact the maintenance
Medium C power board charging
personnel.
Charge Fault
circuit failure
IV-10
System Alarm Information
Self-test items
Last self-test
Low C failed in the last Perform self-test again.
has failed.
self-test.
Pace Unlrmal
High A Pacing failure Re-pacing
Stop
Fault code,
defibrillation
malfunction or
Restart the instrument. If
simultaneous
Defib/Pace the fault persists, please
High C defibrillation
Malfunction contact the manufacturer
malfunction and
for repair.
pacing malfunction.
IV-11
System Alarm Information
No SD card No SD card
Low A Install SD card.
Others exist! installed
IV-12
System Alarm Information
IV-13
System Alarm Information
Ip conflict None
Sampling None
Relearn None
Arr Learning None
The same module exists,only
one can be kept! None
IV-14
Appendix V Factory default configuration
V-2
Factory default configuration
NIBP White
TEMP White
CO2 Yellow
IBP Red
V-4
Factory default configuration
V-5
Factory default configuration
(19) PR settings
V-6
Factory default configuration
ART, P1, P2, LV, Ao, UAP, BAP and FAP settings
Scale (0,150)
SYS alarm ADU (90,160)
limit
PED (70,120)
NEO (55,90)
PED (50,90)
NEO (35,70)
NEO
NEO
NEO
V-8
Factory default configuration
V-9
Appendix VI EMC
Attention
The monitor meets the requirement of electromagnetic compatibility in IEC60601-1-2.
The user needs to install and use according to electromagnetism compatibility information
which is attached with it.
Portable and mobile RF communicationdevices may influence the monitor performance, so the
monitor should be kept away from them during using.
Guidance and manufacturer’s declaration stated in the appendix.
Warning
the monitor should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the monitor should be observed to verify normal operation
in the configuration in which it will be used.
Use accessories and cables other than those sold by the monitor manufacturer as replacement
parts of internal components and parts may cause the monitor increase of transmission or
reduction of immunity.
Harmonic emissions The monitor defibrillation monitor is suitable for use in all
IEC 61000-3-2 Class A facilities that are not home and are not directly connected to
the residential public low-voltage power supply network for
Voltage fluctuations / domestic use.
flicker emissions Complies
IEC 61000-3-3
VI-1
EMC
VI-2
EMC
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 reorienting or relocating the monitor .
d. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3Vrms. In ISM bands,
field strengths should be less than 10Vrms.
VI-4
Appendix VII Defibrillation Monitor Shift Checklist
Please check the defibrillator monitor once a day according to the items in the list below. Check the passed
items by typing ―√‖ or ―×‖ in the ―pass/fail‖ column, indicating pass and fail respectively, and filling in ―-‖
for items not involved. If the device is found to be abnormal during the inspection process, please describe it
in the ―Exception Description‖ column.
Device name: Serial No.: Department name:
Test item Description Pass/Fail Exception
description
Device appearance Device surface is clean, with no
damage, crack and foreign matter
Battery Equipped with battery, battery
indicator is on, and battery icon shows
more than 3 grids
AC power Connect AC power, and the AC power
indicator lights up
Recording paper Recording paper is loaded and the
recording paper is sufficient
Cable and connector The cable is not damaged, and the plug
pin is not loose or bent
ECG cable and The ECG cable and electrode pads are
electrode pad complete, the cable is not damaged, the
(not used is not plug pins are not loose or bent, and the
involved) electrode pads are not expired.
Electrode pad The electrode paddle cable is not
(not used is not damaged, the plug pin is not loose or
involved) bent, and the electrode paddle is
correctly placed in the electrode paddle
slot.
Treatment cable and The treatment cable and electrode pads
electrode pad are complete, the treatment cable is not
(not used is not damaged, the plug pins are not loose or
involved) bent, and the electrode pads are not
expired.
Treatment cable shock Turn on the unit, select ―Manual
test* Defibrillation‖, connect the treatment
(not used is not cable and test the load. The charging
involved) value is 200J. Press the ―Discharge‖
button to indicate that the electric
shock is released normally. Remove
the test load after the test is complete.
Electrode paddle Turn on the unit, select "Manual
shock test** Defibrillation", connect the electrode
VII-1
Defibrillation Monitor Shift Checklist
*: This check is required only if the automatic self-test or the automatic self-test fails when the treatment cable
is not used.
**: This check is required only if the automatic self-test or the automatic self-test fails when the electrode
paddle is not used.
Attention
After the test is completed, if the test load is not removed, the patient's treatment may be
delayed.
VII-2