Preface

Thank you for using M8500 patient monitor.

In order to enable you to skillfully operate Monitor as soon as possible, we provide this
user’s manual with delivery. When you install and use this instrument for the first time, it
is imperative that you read carefully all the information that accompanies this instrument.
Based on the need to improve the performance and reliability of the parts and the whole
instrument, we sometimes will make some amendments to the instrument (including the
hardware and software). As a result, there might be cases of discrepancies between the
manual and the actual situation of products. When such discrepancies occur, we will try
our best to amend or add materials. Your comments and suggestions are welcome.

Contact Information
Address: No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone,
Zhuhai , P.R.China
Post code: 519085
Fax: +86-756-3399919
Toll-free consultation hot line: +86-400-8818-233

Statement
This manual contains exclusive information protected by copyright laws and we reserve
its copyright. Without written approval of manufacturer no parts of this manual shall be
photocopied, Xeroxed or translated into other languages.

The contents and version contained in this manual are subject to amendments without
notification.
The version number of this manual: V3.0
The version number of software: V2.2.4

I
Manufacturer’s Responsibility

Only under the following circumstances will manufacturer be responsible for the safety,
reliability and performance of the instrument.

 All the installation, expansion, readjustment, renovation or repairs are conducted

by the personnel certified by manufacturer.

 The electrical safety status at the installation site of the instrument conforms to
the national standards.

 The instrument is used in accordance with the operation procedures.

CE mark

EC Representative Name:
Shanghai International Trading Corp. GmbH (Hamburg)

EC Representative Address:
Eiffestrasse 80, 20537 Hamburg Germany

Copyright reserved © 2013 Guangdong Biolight Meditech Co., Ltd.

II
 Contents

Chapter 1 General Introduction.............................................................................................1

1.1 Intended Use...................................................................................................................... 1
1.2 About this Manual.............................................................................................................1
1.3 Brief Introduction to the Monitor.................................................................................... 3
1.4 Appearance and Structure of the Monitor....................................................................... 4
Chapter 2 Important Safety Notes......................................................................................... 1
2.1 General Safety................................................................................................................... 1
2.2 Some Important Notes for Safety.....................................................................................3
2.3 Classifications....................................................................................................................5
2.4 Safe Operating and Handling Conditions........................................................................6
Chapter 3 Preparations before the Use of the Monitor...................................................... 1
3.1 Unpacking and Checking..................................................................................................1
3.2 Connecting to Power.........................................................................................................1
3.3 Connecting to the Central Monitor System.....................................................................3
3.4 Starting the Monitor..........................................................................................................4
3.5 Connecting to Various Kinds of Sensors.........................................................................4
3.6 Preparation of Recorder....................................................................................................4
3.7 Shutting off the Monitor................................................................................................... 5
Chapter 4 Operation Instructions for the Monitor.............................................................1
4.1 Screen Mode...................................................................................................................... 1
4.2 Main Menu.........................................................................................................................5
4.3 Screen Display.................................................................................................................36
Chapter 5 Parameters Measurement.....................................................................................1
5.1 Measurement of ECG/HR................................................................................................ 1
5.2 Measurement of RESP....................................................................................................13
5.3 Measurement of SpO2/Pulse...........................................................................................15
5.4 Measurement of TEMP...................................................................................................22
5.5 Measurement of NIBP.................................................................................................... 25
5.6 Measurement of CO2 (Microstream, LoFlo)................................................................ 32
5.7 Measurement of CO2(Mainstream, CAPNOSTAT5)..................................................39
5.8 Measurement of AG........................................................................................................43
Chapter 6 Alarm........................................................................................................................1

III
 6.1 Alarm Category and level.................................................................................................1
6.2 Alarm Modes..................................................................................................................... 1
6.3 Alarm Setup....................................................................................................................... 3
6.4 Alarm Cause.......................................................................................................................5
6.5 Silence/Suspension............................................................................................................5
6.6 Parameter Alarm................................................................................................................6
6.7 When an Alarm Occurs.....................................................................................................7
6.8 Alarm Description and Prompt.........................................................................................7
Chapter 7 Recording.................................................................................................................1
Chapter 8 Other Functions......................................................................................................1
8.1 Nurse Call.......................................................................................................................... 1
Chapter 9 Maintenance and Cleaning...................................................................................1
9.1 System Check.................................................................................................................... 1
9.2 Battery Maintenance......................................................................................................... 2
9.3 General Cleaning...............................................................................................................3
9.4 Cleaning Agents................................................................................................................ 4
9.5 Disinfection........................................................................................................................4
Chapter 10 Accessories.............................................................................................................1
Appendix A Product Specifications........................................................................................1
A.1 Environmental Specifications..........................................................................................1
A.2 Hardware Specifications..................................................................................................1
A.3 Measurement Specifications............................................................................................3
Appendix B Default System Setup....................................................................................... 15
B.1 System............................................................................................................................. 15
B.2 Alarm Limit.....................................................................................................................17
Appendix C EMC....................................................................................................................19

IV
 Patient monitor user’s manual

Chapter 1 General Introduction

1.1 Intended Use

The Monitor is used to monitor patient’s physiological parameters such as ECG、RESP、

SpO2 、 NIBP 、 TEMP 、 CO2 and AG continuously. It is intended to be used in various
hospital rooms such as Coronary Care Unit，Intensive Care Unit，Neonatal Intensive Care
Unit and Operating Room to provide additional information to medical and nursing staff
about the physiological condition of the patient.
It is not intended to be used in outdoor transport applications.

1.2 About this Manual

This manual contains the instructions necessary to operate the product safety and in
accordance with its function and intended use. Observance of this manual is a prerequisite
for proper product performance and correct operation and ensures patient and operator
safety.
This manual is based on the maximum configuration and therefore some contents may
not apply to your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the
equipment so that it can be obtained conveniently when needed.
The manual is geared for clinical professionals who are expected to have a working
knowledge of medical procedures, practiced and terminology as required for monitoring
patients.
All illustrations in this manual serve as examples only. They may not necessarily reflect
the setup or data displayed on your product.

Signs in this manual:

 Warning: Means it must be strictly followed so as to prevent the operator or the

patient from being harmed.

Caution: Means it must be followed so as not to damage the instrument.

 Note: Important information or indications regarding the operation or use.

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 Warning:
 Before putting the system into operation, verify that the equipment, connecting
cables and accessories are in correct working order and operating condition.
 To avoid explosion hazard, do not use the equipment in the presence of
flammable anesthetics, vapors or liquids.
 Do not open the equipment housings; electric shock hazard may exist. All
servicing and future upgrades must be carried out by the personnel trained and
authorized by manufacturer only.
 When using the equipment with electrosurgical units (ESU), make sure the
patient is safe.
 Do not come into contact with the patient during defibrillation. Otherwise
serious injury or death could result.
 Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level or off may result in a hazard to the
patient. Remember that alarm settings should be customized according to
different patient situations and always keeping the patient under close
surveillance is the most reliable way for safe patient monitoring.
 The physiological data and alarm messages displayed on the equipment are for
reference only and cannot be directly used for diagnostic interpretation.
 To avoid inadvertent disconnection, route all cables in a way to prevent a
stumbling hazard. Wrap and secure excess cabling to avoid risk of entanglement
or strangulation by patient or personnel.

Caution:
 To ensure patient safety, use only parts and accessories specified in this manual.
 At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such
products. If you have any questions concerning disposal of the equipment, please
contact us.
 Magnetic and electrical fields are capable of interfering with the proper
performance of the equipment. For this reason make sure that all external
devices operated in the vicinity of the equipment comply with the relevant EMC
requirements. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic
radiation.
 Before connecting the equipment to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the

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equipment’s label or in this manual.

 Always install or carry the equipment properly to avoid damage caused by drop,
impact, strong vibration or other mechanical force.

1.3 Brief Introduction to the Monitor

The monitor has features as follows:

 Multiple measuring functions include 3-lead, 7-lead ECG/HR, RESP, dual TEMP,
SpO2/Pulse, NIBP, CO2 and AG are optional.
 Complete built-in module design ensures stable and reliable performance
 Unique all-lead ECG on-one-screen display, which can facilitate the diagnosis and
analysis of cardiac disease
 Function of reviewing 10 minutes one important lead’s EGC waveform
 Can store the trend data for 120 hours and has the function of displaying trend data
and trend graphs
 Function of alarm event reviewing, can store 1000 pieces of alarm events
 Function of NIBP measurement reviewing, can store 750 pieces of NIBP measurement
data
 Built-in recorder is optional and it supports real-time recording, trigger printout by
alarm
 Parameter display with big character
 Optional function of Calculator of drug concentration
 Optional function of Display of oxyCRG
 Function of Display of short trend
 8″authentic color high brightness TFT LCD monitor
 Portable design, stylish and convenient
 Rechargeable maintenance-free battery, can continue working when AC power is off
 Nurse call function guarantee patient alarm draws enough attention
 Can be connected with the central unit to realize centralized monitoring
 Is resistant to high-frequency electrotome and is protected against defibrillation effects

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1.4 Appearance and Structure of the Monitor

1.4.1 Front View

10 9 8

1. Alarm indicating lamp

2. Press this button to exit the present menu and return to main screen.
3. Press this button to start or stop the NIBP measurement.
4. Press this button in 2 seconds to make the monitor alarm paused or cancel
the pause. Press and hold this button for 2 seconds can silence the monitor’s audio
system or cancel the silence. When the nurse call function is enabled, pressing this
button can cancel the current nurse call alarm.
5. Press this button to freeze or defreeze the waveform.
6. Press this button to start or stop the real-time recording.
7. Trim Knob
The Trim Knob is used for:
 Turn left or turn right to move the cursor.
 Press down to perform an operation, such as open the menu dialog or select
one option.

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8. Power indicating lamp

 It is illumined green when the AC power is connected.
 It is illumined orange when the AC power is not connected and monitor is
powered by battery.
 It is turned out when the AC power is not connected.
9. Battery charging indicating lamp
 It is illumined when the battery is being charged.
 It is go out when the battery is fully charged or no battery in monitor

10. Power button

1.4.2 Left View

1
4
2

5 3

1. CO2/AG socket
2. TEMP socket
3. NIBP cuff connector
4. ECG socket
5. SpO2 socket
6. Battery compartment

 Warning: The sensor cable sockets on Monitor can only be connected with the
sensor cables supplied with this instrument and no other cables shall be used.

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1.4.3 Right View

1. Recorder

1.4.4 Rear View

1
6
2

5 4 3
1. AC input socket

2. Slip board of AC/DC input socket

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 Patient monitor user’s manual

 Slip the board to the bottom place if you want to use the AC power;
 Slip the board to the top place if you want to use the DC power.

3. 12V DC input socket

4. Network connector
Standard RJ45 socket. It is used for connection with the central monitoring system
provided by manufacturer.

5. RS 232 socket / VGA display connector

 When this socket is RS 232 socket, it is only used for maintenance and upgrading of
the monitor by the technical personnel authorized by manufacturer.
 When this socket is VGA display connector, it is connected to standard VGA display
for secondary displaying.

6. Nurse call connector / Defibrillator synchronization socket

 When this socket is nurse call connector, it can be connected to nurse call system in
hospital. When an alarm occurs, outputting the nurse call signal to remind nurse.
 When this socket is defibrillator synchronization socket, it can be connected to
defibrillator for output defibrillator synchronization signal.

7. Potential equalization conductor terminal

Base on the requirements of safety and anti-interference, the monitor must be
connected with potential equalization system individual. Connect the Potential
equalization conductor terminal to the potential equalization system with the green and
yellow potential equalization cable. If the protection earth system is damaged, the
potential equalization system can take on the safety function of protection earth conductor.

8. Hidden handle

Caution: The AC input socket at the back panel of the monitor can be connected
with 100-240V AC power by electrical wires supplied with this instrument.

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 Patient monitor user’s manual

1.4.5 Notes on the signs on the monitor

Signs Notes on the signs

Type CF applied part, defibrillation protected
The unit displaying this symbol contains an F-Type isolated (floating)
applied part providing a high degree of protection against shock, and is
defibrillator-proof.
Type BF applied part, defibrillation protected
The unit displaying this symbol contains an F-Type isolated (floating)
applied part providing a high degree of protection against shock, and is
defibrillator-proof.

Attention: Consult accompanying documents (this manual).

Non-ionizing radiation

Dangerous voltage

Equipotentiality

Alternating current (AC)

Network connector

Nurse call connector

Defibrillator synchronization output socket

VGA display connector

CE mark

Symbol for the marking of electrical and electronics devices according to

Directive 2002/96/EC.
The device, accessories and the packaging have to be disposed of waste
correctly at the end of the usage. Please follow local ordinances or
regulations for disposal.

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Signs Notes on the signs

ECG Short for “Electrocardiogram”

RESP Short for “Respiration”

SpO2 Short for “Pulse Oxygen Saturation”

TEMP Short for “Temperature”

NIBP Short for “Non-invasive Blood Pressure”

CO2 Short for “Carbon dioxide”

AG Short for “Anesthetic gas”

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Chapter 2 Important Safety Notes

 Warning: For pacemaker patients, Rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not
rely entirely upon rate meter alarms. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse rejection
capability of this instrument.

 Warning: Only trained doctors and nurses can use the device.

 Warning: The monitor is neither a therapeutic instrument nor a device that can
be used at home.

2.1 General Safety

1. Safety precautions for safe installation

 The input socket of monitor can be connected to the electrical wires and common
electrical wire can be used.
 Only the power supply type of AC 100-240V 50/60Hz specified by monitor can
be used.
 Connect the electrical wire to a properly grounded socket. Avoid putting the
socket used for it in the same loop of such devices as the air conditioners, which regularly
switch between ON and OFF.
 Avoid putting the monitor in the locations where it easily shakes or wobbles.
 Enough space shall be left around the monitor so as to guarantee normal
ventilation.
 Make sure the ambient temperature and humidity are stable and avoid the
occurrence of condensation in the work process of the monitor.

 Warning: Never install the monitor in an environment where flammable

anesthetic gas is present.
2. Monitor conforms to the safety requirements of IEC 60601-1:1988+A1:1991+A2:1995.
This monitor is protected against defibrillation effects.

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3. Notes on signs related to safety

Type CF applied part, defibrillation protected
The unit displaying this symbol contains an F-Type isolated (floating)
applied part providing a high degree of protection against shock, and is
defibrillator-proof.
The type CF applied parts provide a higher degree of protection against
electric shock than that provided by type BF applied parts.
Type BF applied part, defibrillation protected
The unit displaying this symbol contains an F-Type isolated (floating)
applied part providing a high degree of protection against shock, and is
defibrillator-proof.
Attention! Please refer to the documents accompanying this monitor
(this manual)!
4. When a defibrillator is applied on a patient, the monitor may have transient disorders in
the display of waveforms. If the electrodes are used and placed properly, the display of the
monitor will be restored within 10 seconds. During defibrillation, please note to remove
the electrode of chest lead and move the electrode of limb lead to the side of the limb. The
electrode of the defibrillator should not come into direct contact with the monitoring
electrodes. Please ensure the monitor is reliably grounded and the electrodes used
repeatedly should be kept clean.

 Warning: When conducting defibrillation, do not come into contact with the
patient, the bed and the monitor. Otherwise serious injury or death could be resulted
in.

5. To guarantee the safe operation of the monitor, Monitor is provided with various
replaceable parts, accessories and consuming materials (such as sensors and their cables,
electrode pads). Please use the products provided or designated by the manufacturer.
6. Monitor only guarantees its safety and accuracy under the condition that it is connected
to the devices provided or designated by manufacturer. If the monitor is connected to other
undesignated electrical equipment or devices, safety hazards may occur for causes such as
the cumulating of the leakage current.
7. To guarantee the normal and safe operation of the monitor, a preventive check and
maintenance should be conducted for the monitor and its parts every 6-12 months
(including performance check and safety check) to verify the instrument can work in a
safe and proper condition and it is safe to the medical personnel and the patient and has
met the accuracy required by clinical use.

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Caution: The monitor does not contain any parts for self-repair by users. The
repair of the instrument must be conducted by the technical personnel been
authorized by manufacturer.

2.2 Some Important Notes for Safety

PATIENT NUMBER
The monitor can only be applied to one patient at one time.

INTERFERENCE
Do not use cellular phone in the vicinity of this equipment. High level of
electromagnetic radiation emitted from such devices may result in strong interference with
the monitor performance.

ACCIDENTAL SPILLS
To avoid electric shock or device malfunction, liquids must not be allowed to enter the
device. If liquids have entered the device, take it out of service and have it checked by a
service technician before it is used again.

ACCURACY
If the accuracy of any value displayed on the monitor or printed on a printout paper is
questionable, determine the patient’s vital signs by alternative means. Verify that all
equipment is working correctly.

ALARMS
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment
of alarm volume to a low level or off during patient monitoring may result in a hazard to
the patient. Remember that the most reliable method of patient monitoring combines close
personal surveillance and correct operation of monitoring equipment.
The functions of the alarm system for monitoring the patient must be verified at regular
intervals.

BEFORE USE
Before putting the system into operation, please visually inspect all connecting cables
for signs of damage. Damaged cables and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct working order and

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operating condition.
Periodically, and whenever the integrity of the product is in doubt, test all functions.

CABLES
Route all cables away from patient’s throat to avoid possible strangulation.

TO CLEAR PATIENT DATA

When monitoring a new patient, you must clear all previous patient data from the
system. To accomplish this, shut down the device, and then turn on it. Selecting 〈New
patient〉in〈main setup〉menu can also clear the previous patient data.

DISPOSAL OF PACKAGE
Dispose of the packaging material, please observe the applicable waste control
regulations and keeping it out of children’s reach.

EXPLOSION HAZARD
Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.

LEAKAGE CURRENT TEST

When interfacing with other equipment, a test for leakage current must be performed by
qualified biomedical engineering personnel before using with patients.

BATTERY POWER
The device is equipped with a battery pack. The battery discharges even when the
device is not in use. Store the device with a fully charged battery and take out the battery,
so that the service life of the battery will not be shortened.

DISPOSAL OF ACCESSORIES AND DEVICE

Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
The service life of this monitor is five years. At the end of its service life, the product
described in this manual, as well as its accessories, must be disposed of in compliance
with the guidelines regulating the disposal of such products. If you have questions
concerning disposal of products, please contact manufacturer or its representatives.

EMC
Magnetic and electrical fields are capable of interfering with the proper performance of

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 Patient monitor user’s manual

the device. For this reason, make sure that all external devices operated in the vicinity of
the monitor comply with the relevant EMC requirements. X-ray equipment or MRI
devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation. Also, keep cellular phones or other telecommunication
equipment away from the monitor.

INSTRUCTION FOR USE

For continuous safe use of this equipment, it is necessary that listed instructions were
followed. However, instructions listed in this manual in no way can supersede established
medical practices concerning patient care.

LOSS OF DATA
Should the monitor at any time temporarily lose patient data, close patient observation
or alternative monitoring devices should be used until monitor function is restored.
If the monitor does not automatically resume operation within 60 seconds, restart the
monitor using the power on/off switch. Once monitoring is restored, you should verify
correct monitoring state and alarm function.

2.3 Classifications

The Monitor is classified, according to IEC 60601-1:1988+A1:1991+A2:1995 as:

Type of protection against electric shock: I

Degree of protection against electric shock: BF: CO2, AG
CF: ECG, RESP, TEMP, NIBP, SpO2
Degree of protection against harmful ingress Ordinary Equipment (enclosed equipment
of water: without protection against ingress of water)
Degree of safety of application in the Not suitable
presence of a flammable anesthetic-mixture
with air or with oxygen or nitrous oxide:
Mode of operation: Continuous operation

I: Class I equipment
BF: Type BF applied part
CF: Type CF applied part
Not suitable: Equipment is not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.

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2.4 Safe Operating and Handling Conditions

Method(s) of sterilization or disinfection Sterilization: not applicable

recommended by the manufacturer: Disinfection: See “Maintenance and Cleaning
->General Cleaning”
Electromagnetic interference No cellular telephone nearby
Electro surgical interference damage No damage
Diathermy instruments influence Displayed values and prints may be disturbed or
erroneous during diathermy
Defibrillation shocks The monitor specifications fulfill the
requirements of IEC 60601-1, IEC 60601-2-27,
IEC 60601-2-49

The system must fulfill the requirements of

Auxiliary outputs
standard IEC 60601-1-1

 Warning: Please ensure the monitor is working under specified conditions;

otherwise, the technical specifications mentioned in this manual will not be met, thus
possibly leading to damage of equipment and other unexpected results.

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Chapter 3 Preparations before the Use of the Monitor

3.1 Unpacking and Checking

 Unpack the package

Open the package, accessories include: electrical wire, various patient sensors and
user’s manual (this manual), warranty card, certificate and particular paper and the lower
foam case contains the monitor.
 Remove the monitor and accessories

Caution: Please place the monitor on level and stable supporting plane, not on
the places that can easily shock or wake. Enough room should be left around the
monitor so as to guarantee normal ventilation.

 Keep all the packaging materials for future use in transportation or storage.
 Check the monitor and accessories
Check the monitor and its accessories one by one in accordance with the particular
paper. Check to see if the parts have any mechanical damages. In case of problems, please
contact us or our agent.

3.2 Connecting to Power

3.2.1 AC Power
 Confirm the rated AC current is: AC 100-240V 50/60Hz
 Use the electrical wires provided along with the instrument, put its output end plug
(round headed) into the AC current socket on the back of the monitor, and the plug of
input end into a grounded socket of the mains (It must be a special socket of the hospital),
connect the monitor through the earth one of electrical wires.
 When the indicating light above the power switch on the panel of the monitor is
green, it means the AC power is on. And when the monitor is not connected to AC power
and the DC battery is used as the power source, the indicating light is orange.

 Warning: The monitor must be connected to a properly installed power outlet

with protective earth contacts only. If the installation does not provide for a
protective earth conductor, disconnect the monitor from the power line and operate it
on battery power.

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 Note: The equipment has no mains switch. The equipment is switched

completely only by disconnecting the power supply from the wall socket. The wall
socket has to be easily accessible.

 Note: For measurements in or near the heart we recommend connecting the

monitor to the potential equalization system. Use the green/yellow potential
equalization cable and connect it to the pin labeled with the symbol.

3.2.2 Battery Power

The monitor has a battery pack to provide power to the monitor whenever AC power is
interrupted. The battery is generally referred to as the “battery”.
You must charge the battery before using it. There is no external charger. The battery is
charged when the monitor is connected to AC power. To assure a fully charged battery that
is ready for use, we recommend that the monitor be plugged into AC power whenever it is
not in use.
Run time of the batteries is according to the usage and configuration of monitor. NIBP
and SpO2 monitoring and the usage of the recorder will drain battery power faster than
other parameters.

 Note: When the monitor is connected to AC power, the battery is in a state of

being recharged. When it is unable to be connected to the AC power, the battery can
be used to supply power, and at this time it is unnecessary to use the electrical wires,
and the instrument can be switched on directly.

 Note: A “Battery Low” message displaying at the technical alarm information

area of screen and an audible system alarm indicate approximate 5 minutes of
battery life remaining. You should connect the monitor to an AC power source when
the message is displayed.

 Note: This monitor contains a rechargeable battery. The average life span of this
type of battery is approximately three years. When replacement becomes necessary,
contact a qualified service representative to perform the replacement.

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 Disposal Note: Should this product become damaged beyond repair, or for some
reason its service life is considered to be at an end, please observe all local, state, and
federal regulations that relate to the disposal of products that contain lead, batteries,
plastics, etc.

 Install Battery
The battery compartment is located at the left side of the monitor, following the steps to
install a battery.
1. Open the battery gate according to the direction marked on the monitor.
2. Turn the baffle up clockwise.
3. Push the battery into the gate with the electrode point to the bottom of the monitor.
4. After pushing the battery inside the compartment withdraw, the baffle turn back to the
middle position.
5. Close the battery gate.

 Uninstall battery
1. Open the battery gate according to the direction marked on the monitor.
2. Turn the baffle up clockwise.
3. Take out the battery. Then close the battery gate.

3.3 Connecting to the Central Monitor System

 Warning: Accessory equipment connected to the analog and digital interface

must be certified according to the respective IEC standards (e.g. IEC 60950 for data
processing equipment and IEC 60601-1:1988+A1:1991+A2:1995 for medical
equipment). Furthermore all configurations shall comply with the valid version of
the system standard IEC 60601-1-1. Everybody who connects additional equipment
to the signal input part or signal output part configures a medical system, and is
therefore responsible that the system complies with the requirements of the valid
version of the system standard IEC 60601-1-1. If in doubt, consult the technical
service department or your local representative.

If the user intends to connect the monitor to the central monitoring system, plug its
connecting electrical cable into the Network Connector at the back of the monitor.

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 Note: This monitor can only be connected to the central monitoring system
provided by manufacturer, do not attempt to connect this monitor to other central
monitoring system.

3.4 Starting the Monitor

 Press the power button. The alarm indicating lamps flash, and then go out. The
system gives a beep and displays the startup screen.
 The startup screen disappears and the monitor enters the main screen.

 Warning: In case the monitor is found to be working abnormally or indication

of errors appears, please do not use this monitor for monitoring and should contact
the after-sale service center as soon as possible.

3.5 Connecting to Various Kinds of Sensors

Connect sensor cables to the relevant sockets on the monitor and put sensors on the
monitored locations on the body of the patient. Refer to the relevant content of Chapter 5
for details.

 Warning: For safety reasons, all connectors for patient cables and sensor leads
(with the exception of temperature) are designed to prevent inadvertent
disconnection, should someone pull on the leads. Do not route cables in a way that
they may present a stumbling hazard. Do not install the monitor in a location where
it may drop to the patient. All consoles and brackets used must have a raised edge at
the front.

3.6 Preparation of Recorder

If the monitor you use has been provided with a recorder, before starting of monitoring
please check if the recorder has had recording thermal paper installed. The thermal side
(that is the smoother side) should face upwards and a small section should be pulled out
onto the outlet of the paper (on the right panel of the monitor).

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If record paper has been used up, following the steps to install recording paper.
1. Push down and pull out of the recorder cover to open recorder.
2. Install the paper with the thermal side upwards.
3. Close the recorder with a section of paper outside of the storage.
For detailed operation information, refer to Fig. 3-6-1

Push down and pull out Outside paper

Thermal side of paper

Fig. 3-6-1 Install Recording Paper

3.7 Shutting off the Monitor

Please follow these steps to shut off the monitor:

 Confirm that the patient monitoring is finished.
 Disconnect the cables and sensors form patient.
 Confirm that the monitoring data is stored or cleared.
 Press the power switch, then a dialog will pop up to ask you make sure the shut-off
operation. Select “OK” to shut off the monitor. If the monitor can’t be switched off
normally, forced close the monitor by pressing and holding the power switch more
than 5s. This may cause some damages to the device.

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Chapter 4 Operation Instructions for the Monitor

 Note: In each menu, press〈Previous〉to return to the previous menu and press
the〈Main〉button to return to main screen. In all the dialogue windows, there is help
info to indicate the current operation.

 Note: The monitor configuration is consist of standard and non-standard

parameter configuration, and their operation methods are basically the same, the
standard configuration includes 5-lead ECG, RESP, SpO2, Single TEMP and NIBP
modules, and the non-standard parameter configuration includes Dual TEMP, CO2
and AG modules.

4.1 Screen Mode

In the <Select Screen> of the <Main Setup>menu, seven kinds of different screen
display modes can be selected, namely: Standard, NIBP Review, Big Numerics, Short
Trend, 7 leads, oxyCRG, Other Bed. They are respectively showed as follow:
1） Standard

The ECG waveform of one lead is displayed on the uppermost region above the
waveforms (this lead is called key monitoring lead and is set by the <ECG1> option in
<ECG>), and the waveforms below are displayed differently according to different
configurations.

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2） NIBP Review

The recent groups of NIBP measurement results are displayed below the waveforms and
the measurement records can be browsed by turning the trim knob.

3） Big Numerics

The main parameters are displayed in big font, e.g. HR, SpO2, NIBP, RESP and CO2.

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4） Short Trend

The short trend diagram relevant to the parameters is displayed on the upper-left corner
of the waveform.

5） 7-Leads

The ECG waveforms of 7-lead are displayed in the waveform display zone, they are
I, II, III, aVR, aVL, aVF, and V- respectively.

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6） OxyCRG

The trend diagrams of HR, SpO2 and RESP within 16 minutes are displayed under the
waveforms.

7） Other Bed

The info for other beds is showed below the waveforms, including one waveform and
parts of parameters. Among them, through <Bed NO>, the number of online machine can
be selected and through <Bed wave> the waveform display of other beds can be selected.
Press <Run> to initiate monitoring of other beds, and press <Stop> to terminate the
present monitoring of other beds. Switching from monitoring of other beds screen to other
screens will automatically terminate the present monitoring of other beds.

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4.2 Main Menu

Screen Such seven display modes as Standard, NIBP Review, Big Numerics, Short
Trend, 7 leads, oxyCRG and Other Bed can be selected. And the display mode varies
according to different manufacturer configurations.
Monitor Click and open the dialog of monitor configuration. Conduct some
configurations of the monitor.
Trend Review Click and open the dialog of trend browse. Browse trend tables or trend
diagrams.
Alarm Review Click and open the dialog of alarm event review. Browse alarm events.
ARR Review Click and open the dialog of arrhythmia review. Browse the waveforms
and events of arrhythmia.
Alarm Setup Click and open the dialog of alarm configuration. Conduct configuration
of alarm parameters.
New Patient Terminate the monitoring of the current patient and initiate the monitoring
of a new patient. Pressing the option will delete the monitoring data of the current patient
and patient Info and initiate the monitoring of a new patient.
Patient info Click and open the dialog of patient info. It provides the input and browse
of patient info.
Calculator Click and open the dialog of calculator.
Standby Click and enter the standby state.

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Caution: After initiating the monitoring of a new patient, the data of historical
patients will be completely eliminated.

4.2.1 Monitor Setup

Beep Volume Set the volume of BEEP and options are Off, 1, 2, 3. After one selection is
made, a testing beep will be produced.
Alarm Volume Set the alarm volume and options are Off, 1, 2, 3. After one selection is
made, a testing beep will be produced.
Wave Setup Click and open the dialog of waveform configuration. Conduct the
customization of screen waveforms and relevant waveform displays can be selected
according to needs.
Select Modu. Click and open the dialog of module configuration. Some of the modules
not in current use can be switched off, and after switching-off, the relevant parameters and
waveforms will not be displayed and no alarm will be made.
Trend Store Click and open the dialog of configuration of trend storage. It provides the
configuration function on the mode of trend storage and several modes of trend storage
can be defined.
Short Trend Click and open the dialog of short trend diagram. Some scales and time of
short trend diagram can be defined.
System Setup Click and open the dialog of system configuration. Conduct the
configuration and maintenance of systems.
System Info Click and open the dialog of system info. Some info of the system will be

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displayed, such as version info.

Demo Switch on or switch off demonstration function.

 Waveform Setup

Waveform 1 Select the waveform displayed in the first line, and according to the lead
types, different ECG waveforms can be selected (Note: The lead must be the ECG
Waveform, and cannot be switched off). At 3-Leads mode, it is the key monitoring lead
and it is defaulted as Lead II.
Waveform 2 Select the waveform displayed in the second line, and options are Off,
Cascade and random waveform. When selecting <Cascade>, waveform 2 is the cascade
of waveform 1.
Waveform 3 Select the waveform displayed in the third line. Select Off close the wave
display or select certain waveform to display.
Waveform 4 Select the waveform displayed in the fourth line. Select Off close the wave
display or select certain waveform to display.
Waveform 5 Select the waveform displayed in the fifth line. Select Off close the wave
display or select certain waveform to display.
Waveform 6 Select the waveform displayed in the sixth line. Select Off close the wave
display or select certain waveform to display.
Waveform 7 Select the waveform displayed in the seventh line. Select Off close the
wave display or select certain waveform to display.
Waveform 8 Select the waveform displayed in the seventh line. Select Off close the
wave display or select certain waveform to display.
Waveform 9 Select the waveform displayed in the seventh line. Select Off close the
wave display or select certain waveform to display.

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Waveform 10 Select the waveform displayed in the seventh line. Select Off close the
wave display or select certain waveform to display.

 Select Module

SpO2 Module Enable/Disable the display of SpO2 module. After switching-off, the SpO2
parameters and relevant alarm will not be displayed and the current SpO2 waveform will
be automatically switched off. After it is open, the SpO2 waveform will also be opened.
NIBP Module Please refer to SpO2 module instruction
Resp Module Enable/Disable the display of Resp module. After switching-off, the Resp
parameters and relevant alarm will no be displayed and the current Resp waveform will be
automatically switched off. After it is open, if there is no CO2 module, the Resp waveform
will be opened automatically.
CO2 Module Enable/Disable the display of CO2 module. After switching-off, the CO2
parameters and relevant alarm will no be displayed and the current CO2 waveform will be
automatically switched off. After it is open, the CO2 waveform will be automatically open,
if there is an RESP waveforms, the RESP waveform will be switched off.
Gas Module Please refer to SpO2 module instruction
Temp Module Click and open the dialog of Temp module setup.

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Temp 1 Module Enable/Disable the display of Temp 1 module

Temp 2 Module Enable/Disable the display of Temp 2 module

 Trend Storage Setup

Interval Select the cycle intervals of trend storage and options are Off, 1min, 2min,
3min, 4min, 5min, 10min, 15min, 20min, 25min and 30min.
NIBP storage Enable/Disable the switch of NIBP storage. When it is enabled, it
indicates after NIBP measurement completed, a record will be stored.

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ALM storage Enable/Disable the switch of alarm storage. When it is enabled, it

indicates if there is a high alarm of physiological parameters a record will be stored.
Warn storage Enable/Disable the switch of warning storage. When it is enabled, it
indicates if there is a medium alarm of physiological parameters a record will be stored.

 Short trend Setup

Time Scale Select the time interval of short trend diagram. Options are 5min, 10min,
15min, 20min, 30min, 1h and 2h.
HR Scale Select the scale of heart rate for short trend diagram. Options are 0~160/min
and 0~300/min.
SpO2 Scale Select the scale of SpO2 for short trend diagram. Options are 40~100%,
60~100% and 80~100%.
Resp Scale Select the scale of respiration rate for short trend diagram. Options are
0~8/min, 0~24/min, 0~50/min and 0~100/min.
ST Scale Select the scale of ST-segment for short trend diagram. Options are -2~+2mm,
-5~+5mm and -9~+9mm.
EtCO2 Scale Select the scale of EtCO2 for short trend diagram. Options are 0~30mmHg,
0~60mmHg and 0~100mmHg.

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 System Setup

Language The categories of languages can be selected. To change the language, it is

necessary to restart the monitor.
Recorder Click and open the dialog of recorder configuration.
Time Setup Click and open the dialog of time configuration. After the time of the
system has been configured, please restart the monitor.
Mode Config Click and open the dialog of mode configuration.
Alarm Level Click and open the dialog of alarm level configuration.
Machine Click and open the dialog of machine maintenance. Enter the interface of
machine maintenance and it is necessary to enter the password (The password is 125689)
Nurse call Click and open the dialog of nurse call setting. Please refer to chapter 8.1
for details.
Brightness Set the brightness of monitor screen, the options are 1, 2, 3, 4 and 5.

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 Recorder Setup

Record Wave1 Select the waveform recording in the first line. Select certain waveform
to record. It cannot be switched off.
Record Wave2 Select the waveform recording in the second line. Select Off close the
wave display or select certain waveform to record.
Record Wave3 Select the waveform recording in the third line. Select Off close the
wave display or select certain waveform to display.
Record Time Select the time duration of the waveform for each recording. Options are
8s, 12s and 16s.
Interval Select the time interval for cycle recording. Options are Off, 1min, 2min,
3min, 4min, 5min, 10min, 15min, 20min, 25min and 30min.
Delay Time Delayed recordings start documenting on the recorder strip from a preset
time before the recording is started. This interval is called the “Delay Time” and can be set
to Real time, 4s or 8s.
Record Grid Enable/Disable recording of the grids when the recorder is producing
waveforms.
Alarm Record Enable/Disable the alarm recording at the high level of physiological
alarm.
Warn Record Enable/Disable the warn recording at the medium level of physiological
alarm.
Manual Time Set the manual recording time. Options are off, 10s, 20s and 30s.

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 Time Setup

The user can configure system time. The user is advised to set system time before
implementing monitoring. If the configuration is to be conducted during the process of
monitoring, the user is advised to switch off the monitor after exiting the current window
and then restart it. The time for the revision takes effect after the current window is exited.

 Mode Setup

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Factory Select the default configuration defined by the manufacturer and options are
Cancel, Adult, Children and Neonatal, select〈Cancel〉to abort it.
User Config Select the mode of user saving. Select the previous custom configuration,
select〈Cancel〉to abort it.
Save Config Save the current configuration info as custom configuration, enter the
name of the user custom configuration, select〈OK〉to save the current mode and select
〈Cancel〉to cancel saving.
Delete Delete the previous data of custom configuration, select the custom configuration
that needs to be deleted; press the selected mode to delete the mode, and press〈Cancel〉
to cancel deleting.

Caution: The mode name cannot be black when saving current configuration,
otherwise, the custom configuration will not be save.

 Alarm level Setup

Alarm levels of all the parameters can be configured. Press <Set Alarm level > option,
the cursor will move to the region of configuring alarm levels. If the alarm level of a
certain parameter is to be configured, first move the cursor to the alarm level of that
parameter, press the option and then select the alarm level, Options are low, med and
high.

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 Machine Setup

Maintenance Click and open the dialog of system maintenance.

Factory Manufacturer maintenance is not an operation option for users and it must be
operated by the technical and maintenance personnel authorized by
manufacturer.
Upgrade Click and open the dialog of updating monitor’s software.
Nurse Call Click and open the dialog of nurse call.
CO2 Function Click and open the dialog of function selection. Options are CO2 Cal
Mode, CO2 Gain Cal, CO2 Flow.
Fun. Select Click and open the dialog of function selection. Options are Alarm Limit,
ShortCut Key, ARR Level, ECG BaseLine, ECG Auto and
AlarmSound.
Alarm Setup Click and open the dialog of alarm setup. You can check or set the alarm
limit and alarm state.
HUM Select the frequency of the industrial frequency and options are 50Hz and 60Hz.
It is mainly configured according to the frequency of local power supply.
ECG Scale Select〈On〉or〈Off〉to enable or disable ECG scale.

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 System Maintenance

Trend Setup Click and open the dialog of trend display configuration. Conduct
configurations of trend diagrams and trend tables.
Color Click and open the dialog of color configuration and configure colors of
parameters and waveforms.
Network Click and open the dialog of network configuration. Conduct network
configurations.
OverPress Initiate NIBP over-pressure test
Manometer Initiate NIBP manometer test.
NIBP reset Reset NIBP module.
Recor. Cali. Conduct speed calibration of the recorder. This operation must be conducted
when the recorder is changed.

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 Trend Setup
The user can define various trend display info according to needs or use the display
configuration for default trend.

Trend Graph1 Configuration of trend diagram.

There are a total of three pages of trend diagrams and on each page trend diagram can
be configured for six regions, and options are Off, HR, SpO2, NIBP, PR, Resp, CO2, T1,
T2, AA, N2O, O2, ST, HR+SpO2, SpO2+PR, Resp+CO2, PR+CO2, T1+T2,
AA+CO2 ,N2O+O2. It is possible to have self-configurations on the contents of the trend
diagrams and at least one page of trend diagrams shall be configured.

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Trend Table Configuration of trend tables

There are a total of three pages of trend tables and on each page trend table can be
configured for six regions, and options are HR, SpO2, NIBP (S/D), NIBP (M), Resp, PR,
T1, T2, CO2, AA, N2O, O2 ,ST. It is possible to have self-configurations on the contents
of the trend tables and at least one page of trend tables shall be configured.

 Color Setup

Enter the interface of color configuration, the colors of various parameters and
waveforms can be configured.

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 Network Setup

In the interface of network configuration, such items as IP address, Net mask,

Gateway, Machine number can be configured. The configuration is mainly necessary
when the monitor connecting to the Central Unit.
Rcv Alm Lmt Select if allow bedside unit receiving alarm limit from the central unit.
It can be set to ON or OFF.
Set WID Set the wireless ID of the bedside unit.

 System Info

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Version It displays the version number of software.

Module SN It displays the product serial number of module.
Serial Number It displays the serial number of the machine.
New Board It displays the type of the new board.

4.2.2 Trend Review

Trend Graph

Trend Table

Page Press this option and turn the trim knob to conduct the paging operation. Press it
again to restore the initial status. If more than one page of trend diagrams or trend tables
are configured, then the paging is switched between the trend diagrams or trend tables

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between different pages.

Cursor Press this option, turn the trim knob and move the cursor in the trend diagrams
or trend tables. Press it again to restore the initial status. It is possible to move the cursor
in the trend diagrams and trend tables. In the trend tables, it is possible to browse the trend
records by moving the cursor, and if it moves to the left side or the right side of trend
diagram , continue moving can roll the trend diagram by 1/4 screen to the left or right.
Record Press this option to record the trend tables of the current page, but the trend
diagram does not support recording.
Scale Press this option and the time intervals for one page of trend diagrams can be
selected. Options are 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h ,72h and 168h.
Graph Press this option to switch to the display of trend diagram.
Table Press this option to switch to the display of trend tables.

4.2.3 Alarm Review

<</>> Select this button, turn the trim knob to roll the records back and forth.
1/1 Select this button, turn the trim knob to turn the pages back and forth.
Record Print the currently selected alarm events through the recorder; and if no recorder
is configured, this option is invalid.
Exit Exit the dialog of alarm review

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4.2.4 ARR Review

Click and open the dialog of arrhythmia review and the arrhythmia data for 8 seconds
are displayed on each screen, i.e. the ECG waveforms 4 seconds before and after the
occurrence of the event, and a maximum of 128 groups of abnormal data can be stored for
search.
|<< Turn to the first abnormal waveform record.
>>| Turn to the last abnormal waveform record.
<</>> Select this button and turn the trim knob to turn the records back and forth.
Record Print the ECG waveform of the current screen through the recorder. If no
recorder is configured, this option is invalid.
Exit Exit the dialog of Arrhythmia Review.

4.2.5 Alarm Setup

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Common Alarm Click and open the dialog of common parameters alarm. It can setup
the alarm limits of common parameters.

Gas Alarm Click and open the dialog of Gas alarm. It can setup the alarm limits of the
Gas module.

ST Alarm Click and open the dialog of ST alarm. If the ST analysis is not configured,
this option is invalid.

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ARR Alarm Click and open the dialog of ECG analysis alarm. It can setup the alarm
limits of various Arrhythmias.

Alarm Record Click and open the dialog of alarm recording. Configure whether the
alarm records of various modules are recorded. Only when the switch for alarm recording
of the module and the switch for alarm record in the record setup have been switched on,
the physiological alarm in the relevant modules will trigger the alarm recording.

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Alarm volume Configure the volume of alarm and options are off, 1, 2, 3. Once a level
is selected, a testing beep will be produced.

 Note: In each dialog of alarm configuration, press the button〈Adjust Alarm〉and

the cursor moves to the adjustment region of alarm limits. Press the button〈Enable
All 〉 and all the alarms will be opened. If the user desires to adjust the alarm
parameter of a certain parameter, first move the cursor onto the label of that
parameter, and then press the trim knob to move the cursor up and down to select
the parameter to be adjusted for revision.

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4.2.6 Patient Info

Case No. The case number of patients (It can be configured according to the actual
status of the hospital and a maximum of 10 letters can be entered), press〈Del〉to delete
and〈Clear〉to clear; enter〈OK〉to confirm.
Name Patient name (It can be selected among A-Z and 0-9 and a maximum of 10 letters
can be entered) enter〈OK〉to confirm.
Height Body height of patient (Turn the trim knob with an increment or decrement of 1
cm)
Weight Body weight of patient (Turn the trim knob with an increment or decrement of 1
kg)
Sex Gender of patient (male or female)
Age Age of patient (Turn the trim knob with an increment or decrement of 1 year)
Room No. Number of patient’s room. Patient’s room number can be displayed in the
central unit.
Bed No. Number of patient’s bed. Patient’s bed number can be displayed in the central
unit.
Pace Change the paced status. For paced patients, set【Pace】to【Yes】.For non-paced
patients , set【Pace】to【No】.

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4.2.7 Drug Dose Calc

Select〈MENU〉→〈Calculator〉→〈Drug Calc〉，enter the Drug dose calculation
window. As follows:

This calculation of drug concentration is mainly aimed at facilitating the work of

physicians. It conducts concentration calculation on some commonly used drugs. A
content of titration table can be output through recorder.
In the system, the following categories of drugs can be calculated:
AMINOPHYLLINE, DOBUTAMINE, DOPAMINE, EPINEPHRINE, HEPARIN,
ISUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN, and PITOCIN. In addition,
it provides DRUG_A, DRUG_B, DRUG_C, DRUG_D and DRUG_E to displace any
other drugs flexibly.
The following formulas are used for the calculation of drug dosage:
Drug concentration equal to total amount of drug divided by liquid volume
Liquid velocity equal to drug dosage divided by drug concentration
Duration time equal to total amount of drug divided by drug dosage
Drug dosage equal to velocity of IV drip multiply drug concentration
In the window of drug calculation, the operator should first select the name of the drug
to be calculated, confirm the patient weight and then enter other known values.
 Drug name
Move the cursor to〈Drug name〉, press the trim knob, then turn the trim knob to select
drug, and only one kind of drug can be selected for calculation at one time.
DRUG_A, DRUG_B, DRUG_C, DRUG_D and DRUG_E are only codes for drugs
rather than their real names. The units for these five kinds of drugs are fixed and the
operator can select the appropriate units according to the habits of the drugs. The rules of
the units are as follow:

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DRUG_A, DRUG_B, DRUG_C are fixed at the serial units of gram (g), milligram
(mg) and microgram (mcg).
DRUG_D is fixed at the serial units of unit, k unit and m unit.
DRUG_E is fixed at the unit of mEq.

 Weight
The operator should enter the patient weight first, and as independent info the weight is
only used in the function of the calculation of drug concentration.
Turn the trim knob to move the cursor to the positions of the various calculation items
in the calculation formula respectively, turn the trim knob, and select calculation value,
then press the trim knob and confirm the selected calculation value. When the calculation
value is selected, the value of the calculated item will be displayed at relevant locations.
There are range limits for the value adoption of each calculation Item, if the calculation
results exceed the range, “---”will be displayed.
Regarding this function of drug calculation, the values for other individual items can
only be entered after the weight and drug name have been entered. In the system, the
values that are given initially are only a group of random initial values and the operator
shall not take this value as the calculation standard and a group of values appropriate to
the patient must be reentered according to the physicians’ comments.
Each kind of drugs has a fixed unit or unit series and the operator must select the
appropriate units according to the physicians' comments. In the unit series of the same unit,
the addition of the units will be automatically adjusted in accordance with the current
entered value. When the expressed range that can be expressed by this unit is exceeded,
the system will display “---”.
When the operator has entered the value of a certain item, the system will give a prompt
in the menu so as to remind the operator to verify the correctness of the entered value.
Only by ensuring the correctness of the entered values, the calculated values can be
reliable and safe.
In case of neonatal, drip velocity and volume per drip are invalid.
The values in the table may not be related to the patient monitored on this bed.
Therefore the weight of this menu and the weight in the patient info are two different
values. The values in this menu item are not affected by the values in the patient info.

 Titration table
Select〈Titration〉in the menu of drug calculation to enter the interface of titration table.

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In the titration table, turn the trim knob to〈Base〉, then press the trim knob to select the
desired item. Options are Dose, Trans speed and Drop speed. After selecting, press the
trim knob to confirm the selection.
Move the cursor to〈Step〉and press the trim knob to select the step size; the selectable
range is 1-10.
Move the cursor to〈Dose Type〉and press the trim knob to select the dosage unit.
Move the cursor to〈Page Up /Down〉, press the trim knob, and then turn the trim knob
to browse the previous page and next page.
Move the cursor to〈Record〉, press the trim knob to give the output of the data of the
titration table on the currently displayed interface.
Move the cursor to 〈 Exit 〉 , press the trim knob to return to the window of drug
calculation.

4.2.8 Hemodynamic Calculation

 Calculation Process
1. Select 〈 MENU〉→ 〈 Calculator 〉→ 〈 Hemodynamic 〉，enter the Hemodynamic
Calculation window. As follows:

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Please enter the parameter correctly

a. If you are calculating the current patient, the monitor can get C.O., HR, Height
and Weight automatically. You need to put in the other parameters. The way to input
parameters is firstly pitching on the case of the parameter, then turn the knob to enter
its value, lastly press the knob to finish. You can turn the knob to the next parameter
input.
b. If you are not calculating the current patient, no parameter’s value will be offered
by the monitor, you need to input them by yourself.

〈Calc〉Press the button, you will obtain the result window.

〈Exit〉Press the button, you will close the current window.

2. After you have finished the data input, please make sure they are correct. Then you can
press the button〈Calc〉to get the following window:

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〈4/4〉 Press the button, then turn the knob to flip the page. The former “4”
shows the current page, the back one shows the number of the total
pages.
〈Range/Unit〉 Press the button, the unit of the parameter will disappear, and the
unit of the parameter in red word will be changed into the logical range
of them. Press the button again, the unit of them will be displayed.
〈Record〉Press the button, the current page will be printed out.
〈Show Input〉Press the button, the corresponding input of current result will be
present.
〈Exit〉Press the button to quit the current result window.

 Note: The red words mean the parameters’ values are beyond the logical range.
After the output parameter, the sign of “---”will appear sometime, it means
the parameter is invalid .

 Input Parameter
Abbreviation Unit Full Name
C.O. L/min Cardiac output
HR bpm Heart rate
PAWP mmHg Pulmonary artery wedge pressure
Art Mean mmHg Mean artery pressure
PA Mean mmHg Mean pulmonary artery pressure
CVP mmHg Central venous pressure
EDV ml End diastolic volume
Height cm Height
Weight kg Weight

 Output Parameter
Abbreviation Unit Full Name
C.I. L/min/m2 Cardiac index
BSA m2 Body surface area
SV ml Stroke volume
SI ml/m2 Stroke index
SVR DS/cm5 Systemic vascular resistance
SVRI DS·m2/cm5 Systemic vascular resistance index
PVR DS/cm5 Pulmonary vascular resistance

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PVRI DS·m2/cm5 Pulmonary vascular resistance index

LCW kg·m Left cardiac work
LCWI kg·m/m2 Left cardiac work index
LVSW g·m Left ventricular stroke work
LVSWI g·m/m2 Left ventricular stroke work index
RCW kg·m Right cardiac work
RCWI kg·m/m2 Right cardiac work index
RVSW g·m Right ventricular stroke work
RVSWI g·m/m2 Right ventricular stroke work index
EF % Ejection fraction

4.2.9 HRV analysis

Heart rate variability is the tiny difference between successive heart rate interphase. It
comes into being from the modulation of autonomic tones on the sinus nodal autonomy.
And it makes several milliseconds difference and fluctuation between heart rate interphase.
HRV analysis is a sensitive and non-invasive method to estimate the function of
autonomic tones.
Select〈MENU〉→〈Calculator〉→〈HRV Analyze〉，enter the HRV analysis window.
(1) R-R interphase value histogram: It reflects the distribution of R-R interphase value.
The abscissa is the R-R interphase, and the ordinate is the numbers of R-R interphase.
Histogram can reflect the range and extent of R-R interphase variety. The R-R interphase
value histogram is as follows:

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(2) R-R interphase difference histogram: It reflects the difference of R-R interphase,
namely, the extent of sinus arrhythmia. The abscissa is the dispersion of R-R interphase of
sinus beat. The midpoint is zero. The R-R interphase difference histogram is as follows:

（3）Scatter: The abscissa is the R-R interphase of previous heart rate. And the ordinate
is the R-R interphase of next heart rate. The rest may be deduced by analogy. The X-axis
is RRn. The Y-axis is RRn+1. Each heart rate points make the R-R interphase scatter. The
scatter displays the linearity and nonlinear variety trend of HRV. According to the scatter,
you can see the state of autonomic tones function. The scatter is as follows:

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(4) R-R trend graph: It is the summarizing of all kinds of indexes after analyzing the
data in a period of time. It reflects its variety. The abscissa is time. And the ordinate is the
average of R-R interphase in a period of time. The R-R trend graph is as follows:

 Note: HRV analysis can not be used on patient with pacemaker.

4.2.10 Ambulatory blood pressure analysis
Ambulatory blood pressure monitoring is a technology that measures blood pressure in
daily life automatically and discontinuously. It reflects the level, difference and rhythm of
blood pressure.
Select〈MENU〉→〈Calculator〉→〈NIBP Analyze〉，enter the ambulatory blood
pressure analysis window:

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〈Time Length〉: Set the time length of blood pressure monitoring. Options are “24h,
48h”;
〈 Time Inter. 〉 : Set the time interval of NIBP analysis, Options are “5 min,10
min,15 min,30 min”;
〈Start Anal.〉: Click it to begin ambulatory blood pressure analysis.
〈 Anal. Result 〉 : Click it to display the NIBP analysis result. The NIBP analysis
window is as follows:

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4.3 Screen Display

This Monitor adopts color LCD screen with high brightness, which can display
parameters, waveforms, system status and other prompt info. The main screen is mainly
divided into three regions, they are respectively:
 Display zone of system info and alarm prompt info (the uppermost part)
 Waveform display zone (left, and It shall vary according to different screen types)
 Parameter display zone (right and lowest part)

4.3.1 System status

The system time and status of battery capacity are displayed on the upper right corner.

System time Battery capacity

Notes on battery capacities:

Battery capacity is full Battery capacity is half-full

Battery capacity is exhausted

Only when the monitor is powered by battery and is recharging the battery, the icon for
battery capacity is displayed. If AC power in current use and the battery capacity is full,
the icon will not be displayed.
`

 Note: When the battery capacity is exhausted, the system produces an alarm
sound, prompting the user to plug in the AC power for recharging; if it is not
recharged in time, the monitor will be automatically switched off due to insufficient
capacity more than 5 minutes.

Caution: When the energy level of the battery is exhausted, plug in the AC
power to recharge, and then the battery indication may quickly return to “Full
battery level”; the AC plug should be plugged in so as to ensure the full capacity of
the battery.

4.3.2 Info display region

The upper region of the screen is the info display region, which is used to display the

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status of alarm sound, alarm suspension countdown and alarm info.

 Status of alarm sound
The alarm sound is in “Off” status, and if a new alarm is generated, the “Off”
status of alarm sound will be automatically cancelled.
Pause the alarm, and if a new alarm is generated, the “Pause” status of alarm
sound will be automatically cancelled.
 Alarm indicating zone

Physiological Technical alarm

parameter alarm

 Alarm levels
Red base color is high alarm
Yellow base color is medium and low alarm
The order displayed by the physiological parameter alarm is displayed from left to
right in turn according to the alarm levels.
 Parameter alarm
The value of that parameter displayed on the upper part of the screen will flash to
indicate the alarm of that parameter.

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Chapter 5 Parameters Measurement

5.1 Measurement of ECG/HR

5.1.1 Principles of Measuring

Before the mechanical contraction, the heart will firstly produce electrization and
biological current, which will be conducted to body surface through tissue and humors;
the current will present difference in potential in different locations of the body, forming
potential difference ECG, also known as body surface ECG or regular ECG, is obtained by
recording this changing potential difference to form a dynamic curve. Monitor measures
the changes in the body surface potentials caused by the heart of the patient, observe the
cardioelectric activities, record the cardioelectric waveforms and calculate the HR through
the multiple electrodes connected to ECG cable.

5.1.2 Precautions during ECG Monitoring

 Warning: Before connecting the ECG cables to the monitor, please check if the
lead wires and cables have been worn out or cracked. If so, they should be replaced.

 Warning: It is imperative to only use the ECG cables provided with the
instrument by manufacturer.

 Warning: The equipment is capable of displaying the ECG signal in the

presence of pacemaker pulses without rejecting pacemaker pulses.

 Warning: To avoid burning, when the electrotome operation is performed, the

electrodes should be placed near the middle between ESU grounding pad and
electrotome and the electrotome should be applied as far as possible from all other
electrodes, a distance of at least 15 cm/6 in is recommended.

 Warning: When the electrotome operation is performed, the ECG leadwires

should be intertwisted as much as possible. The main unit of the instrument should
be placed at a distance from the operation table. Power wires and the ECG lead
cables should be partitioned and should not be in parallel.

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 Warning: The monitor is protected against defibrillation effect. When applying

defibrillator to the patient, the monitor will experience transient disorderly
waveforms. If the electrodes are used and placed correctly, the display of the monitor
will be restored within 5 seconds. During defibrillation, the chest leads such as V1~V6
should be removed and such limb electrodes as RA, LA, RL, LL should be moved to
the side of the limbs.

 Warning: All the electrodes and conducting part shall not be into contact with
any other conductors including the ground. For the sake of patient safety, all the
leads on the ECG cables must be attached to the patient.

 Warning: When conducting defibrillation, it is imperative to only use the

electrodes recommended by manufacturer.

 Warning: Do not come into contact with the patient, bed and the monitor
during defibrillation.

 Warning: The monitor cannot be directly applied to heart and cannot be used
for the measurement of endocardio ECG.

 Note: When several parts of equipment are interconnected, the total leakage
current is limited to the safety range according to standards IEC 60601-2-27.

5.1.3 Preparatory Steps before the Measurement of ECG/HR

1) Plug the ECG cable into the ECG socket of the monitor.
2) Place the electrodes onto the body of the patient and connect them to the relevant
lead wires of the ECG cables, and at this moment ECG waveforms will appear on the
screen.
3) Set the parameters relevant to ECG monitoring.

5.1.4 Connecting the ECG Cables to the Monitor

Monitor is provided with three different ECG cables relevant to 3-Lead ECG module,
5-Lead ECG module:

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1) 3-lead ECG cable

 Including three limb leads: RA, LL, and LA.
 Realize 3-lead ECG monitoring.
2) 5-lead ECG cable
 Including four limb leads: RA, RL, LL, LA and one chest-lead V (V4).
 Realize 7-lead ECG monitoring.

5.1.5 Connecting the ECG Electrodes to the Patient

1) Connection steps
 Clean the patient’s skin and wipe the oil stains, sweat stains on the skin with alcohol. If
necessary, shave body hair at the locations where the electrodes are to be placed or grind
off the stratum corneum and clean it with alcohol.
 Check if the buttons on the electrodes are clean and free of damage.
 Place the electrodes on the body of patient. Before attaching, smear some conducting
cream on the electrodes if the electrodes are not electrolyte self-supplied.
 Connect the cable leads to the electrodes through the buttons of the electrodes.

 Note: For patients who tremble a lot or patients with especially weak ECG
signals, it might be difficult to extract the ECG signals, and it is even more difficult to
conduct HR calculation. For severely burnt patients, it may be impossible to stick the
electrodes on and it may be necessary to use the special pin-shape electrodes. In case
of bad signals, care should be taken to place the electrodes on the soft portions of the
muscle.

 Note: Check the irritation caused by each electrode to the skin, and in case of
any inflammations or allergies, the electrodes should be replaced and the user should
relocate the electrodes every 24 hours or at a shorter interval.

 Note: When the amplifier is saturated or overloaded, the input signal is medical
meaningless, then the equipment gives an indication on the screen.

2) Location for electrode placement

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RA LA

V1
V2
V3
V4 V5 V6

RL LL

Fig. 5-1-5 Indicative map of the placement of ECG electrodes

The following table shows the lead name to identify each lead wire and its associated
color of AHA and IEC standards.

AHA AHA IEC IEC

Location
Label Color Label Color
RA White R Red Under the clavicle of the right shoulder.
LA Black L Yellow Under the clavicle of the left shoulder.
RL Green N Black Right lower abdomen.
LL Red F Green Left lower abdomen.
V1 Red C1 Red 4th intercostal space on the right sternum side.
V2 Yellow C2 Yellow 4th intercostal space on the left sternum side.
V3 Green C3 Green Center of the line connecting V2 and V4.
Node of the left 5th intercostal space and the
V4 Blue C4 Brown
mid-clavicular line.
Node with the left anterior axillary line at the same
V5 Orange C5 Black
height with V4.
Node with the left mid-axillary line at the same
V6 Purple C6 Purple
height with V4.

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When conducting 3-leads ECG monitoring, use 3-lead ECG cable. The three limb-leads
of RA, LA and LL as shown in Fig. 5-1-5, will be placed on the relevant locations. This
connection can establish the lead of I, II, III.
When conducting 7-leads ECG monitoring, use 5-lead ECG cable. The four limb-leads
of RA, LA, RL and LL as shown in Fig. 5-1-5, will be placed on the relevant locations.
This connection can establish the lead of I, II, III, aVR, aVL, aVF; according to actual
needs, chest lead V can be placed on any of the locations between V1~V6, respectively
making one lead of V1~V6 established.

5.1.6 Setup of ECG/HR parameters

ECG1 Select the ECG waveform, and this lead is the key monitoring lead.
ECG Gain Select the gain item of ECG waveform,and options are AUTO, 0.25x, 0.5x,
1.0x, 2.0x and 4.0x.
HR Source Select HR source item, and common options are AUTO, ECG, PLETH.
When select ART for IBP measurement, the option ART is appeared in HR source.
Beep Volume Select the volume of BEEP, and options are Off, 1, 2, 3. Once an option is
selected, a testing beep will be produced.
Alarm Setup Click and open the dialog of alarm setup.
ECG Setup Click and open the dialog of ECG setup.
ECG Replay Click and open the dialog of ECG replay.
ARR Setup Click and open the dialog of Arrhythmia analysis configuration, Configure
some of the parameters of Arrhythmia analysis.

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 Alarm Setup

ECG alarm Click and open the dialog of HR alarm

Adjust alarm Select this option to enter the configuration of alarm limits and configure
the limits by turning the trim knob to select the high limits and low limits, and exit by
selecting〈EXIT〉. The upper part is the high limit and the lower part is the low limit.
HR alarm Select <ON> to enable HR over limit alarm; select <OFF> to disable HR
over limit alarm.

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ST alarm Click and open the dialog of ST alarm

ST Alarm Select <ON> to enable ST over limit alarm; select <OFF> to disable ST over
limit alarm;
Adjust alarm Select this option to enter the configuration of alarm limits; by turning the
trim knob, select the high limits and low limits for configuration and exit by selecting
〈EXIT〉. The upper part is the high limit and the lower part is the low limit;
Default Select this option and configure the ST alarm as the manufacturer’s default
configuration;
Enable All Select this option and configure all the ST alarms as low level alarms.

ARR alarm Click and open the dialog of Arrhythmia analysis alarm.

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In the interface, it is possible to configure the alarm levels of various Arrhythmia or

switch off the Arrhythmia alarm.

Alarm Setup Select this option to enter the configuration of ECG alarm levels; select
the alarm levels of different Arrhythmia by turning the trim knob and exit by selecting
<EXIT>.
Default Select this option and configure the Arrhythmia alarm as the manufacturer’s
default configuration.
Enable All Select this option and configure all the Arrhythmia alarms as low level
alarms.

 ECG Setup

Lead Type Select the lead type of ECG input, and options are 5 leads, 3 leads and
Auto.
Scan speed Select the scanning speed of ECG waveforms and options are 12.5mm/s,
25mm/s and 50mm/s. The output speed of the recorder remains the same as the scanning
speed of the ECG lead.
MODE Select monitoring mode, and options are USER, DIAG, MON and OPS.
Resp Lead Select the calculation methods of RESP lead, and options are RA-LL,
RA-LA, RL-LA and RL-LL.
DRIFT Select the modes of drift filtrations, and options are Off, Drift 1 and Drift 2.
EMG Select myoelectric filtration, and options are Off, 25Hz and 40Hz.
HUM Select hum frequency filtration, and options are Off and on. Specific frequencies
(50Hz, 60Hz) are configured in〈Machine〉and they must be configured according to the
frequency of local power supply.

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Display PR Select to simultaneity display pulse rate. If simultaneity display of PR is

selected, PR will be simultaneity displayed at the lower left corner of the ECG parameter
display region.

The states of the filter under various modes of ECG

Filter
ECG mode Drift filter HUM filter EMG filter

DIAG OFF OFF OFF

OPS Drift 2 50Hz/60Hz 25Hz

MON Drift 1 50Hz/60Hz 40Hz

USER Optional Optional Optional

 Note：Under the mode of DIAG, OPS and MON, the state of the filter cannot be
regulated. Only under the state of USER can the state be regulated.

Caution: When “3 Lead” is selected as <Lead Type>, ECG is in 3-lead input

mode, and only Lead I, II or III can be measured.

Caution: When “5 Lead” is selected as <Lead Type>, ECG is in 5-lead input mode,
and Lead I, II, III, aVR, aVL and aVF and one chest lead can be measured at the
same time; if chest lead ECG cable is connected, V1~V6 can be measured at the same
time.

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 ECG replay

Start Save: Click it to save the waveform. Click it again to stop saving the
waveform.
Hist. Replay: Enter history replay window.
Curr. Replay: Enter current replay window showed as follows:

<</>> Select this button and it is possible to roll the waveform block by turning the
trim knob back and forth, with 5 seconds each block.
1/1 Select this button, and it is possible to turn the pages back and forth, and the
number before “/” shows the current page and the number following “/” shows total page
numbers.
Record Print the enlarged waveform in current selection through the recorder.

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Exit Exit the dialog of ECG replay.

 ARR Setup

ARR Only when〈ON〉is selected, the monitor will conduct Arrhythmia analysis
ST Only when〈ON〉is selected , the monitor will conduct ST-segment analysis.
Pacemaker Only when〈ON〉is selected ,the monitor will conduct pace-making analysis
on patient with pacemaker.
PVCs Only when the times of continuous occurrences is selected from 1 to 10 , the
monitor will set off the alarm for the frequent occurrences of ventricular premature
contractions.
PACs Only when the times of continuous occurrences is selected between 1 and 10, the
monitor will set off the alarm for the times of premature beat.
ST High ST alarm high limit of arrhythmia analysis, and the unit is mV.
ST Low ST alarm low limit of arrhythmia analysis, and the unit is mV. In arrhythmia
analysis, only when the ST-segment exceeds the configured high and low limits will be
regarded as the elevation or depression of the ST-segment. They are different from the
high and low limit in the configuration of ST alarm limits.
ARR Review Click and open the dialog of arrhythmia review. The user can review the
arrhythmia that have occurred and can browse the waveforms 4 seconds before and after
the occurrence of arrhythmia alarm.

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5.1.7 Functions of Arrhythmia Analysis

 Note: Arrhythmia Analysis software module may be an optional function in your

monitor.

The function is consisting of ST segment analysis and arrhythmia analysis. Arrhythmia

analysis can identify more than 18 kinds of abnormal ECG, as listed in the following
table:

Applicable Patient
Arrhythmia Type Alarm Level
Type
ASYSTOLE All Default High,User selectable
VENT FIB/TACHY Non-paced Default High,User selectable
MULTI PVCS Non-paced Default medium,User selectable
COUPLET Non-paced Default medium,User selectable
BIGEMINY Non-paced Default medium,User selectable
TRIGEMINY Non-paced Default medium,User selectable
RON T Non-paced Default medium,User selectable
VPB Non-paced Default medium,User selectable
TACHY All Default medium,User selectable
BRADY All Default medium,User selectable
MISSED BEATS Non-paced Default medium,User selectable
ST HIGHER All Default medium,User selectable
ST LOWER All Default medium,User selectable
PNP Paced Default medium,User selectable
PNC Paced Default medium,User selectable
NOISE All Default medium,User selectable
VTACHY Non-paced Default High,User selectable
PVCS HIGHER Non-paced Default medium,User selectable

5.1.8 Maintenance and Cleaning

If there is any sign that the ECG cable may be damaged or deteriorated, replace it with a
new one instead of continuing its application on the patient.

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To avoid extended damage to the equipment, disinfection is only recommended when

stipulated as necessary in the hospital maintenance schedule, disinfection facilities should
be cleaned first.
 Cleaning:
Use a piece of clean cloth moistened in water or mild soap solution to clean the ECG
cable.
 Disinfection:
Use a piece of clean cloth to wipe the surface of the cable with a 10% bleach solution or
2% Cidex®, clean with clear water and wipe it dry.

5.2 Measurement of RESP

5.2.1 Principles of Measuring

Monitor measures RESP with the method of impedance. When a patient exhales and
inhales, changes will take place in the size and shape of the thoracic cavity, causing
consequent changes in the impedance between the two electrodes installed at the patient’s
chest. Based on the cycle of impedance changes, the respiration rate can be calculated.

5.2.2 Preparatory Steps of the Measurement of RESP

1) Plug the 5-lead ECG cable into the ECG socket of the monitor.
2) Place the various pads of the electrodes onto the body of patient and connect them to
the relevant lead cables. At this moment, the screen will show RESP waves and the RESP
rate will be calculated.
3) Set the parameters relevant to RESP monitoring.

5.2.3 Connect the ECG Cable with Patient and the Monitor
To measure RESP parameters, it is unnecessary to use other cables and it is only
necessary to use the two RA and LL leads in the 5-lead ECG cable. So please plug the
5-lead ECG cable into the ECG socket and refer to Fig. 5-1-5 to place the RA and LL
leads onto the body of patient.

 Warning: For the sake of safety, all the leads on the 5-lead ECG cable must be
connected to the body of patient.

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Caution: In order to get the best RESP waveforms, when selecting leadⅡfor
measuring RESP, it is advised to place RA and LL electrodes cornerways.

Caution: For reducing the influence of rhythmic blood flow on Resp electrode
pickup impedance changes, avoid the liver area and ventricles of heart in the line
between RA and LL electrodes. This is particularly important for neonates.

Caution: The measurement of RESP is not applicable for patient with excessive
motion, otherwise it may cause the mistake of RESP alarm.

5.2.4 Setup of RESP parameters

Scan Speed Select the scanning speed of RESP waveform, and options are 6.25mm/s,
12.5mm/s and 25mm/s.
Resp Gain Select the waveform gain, and options are 1x, 2x and 4x.
Resp Source When the system is configured with CO2 module, RESP source can be
selected as AUTO, ECG and EtCO2.Only when the monitor that user has bought has CO2
module, EtCO2 of RESP source is valid, otherwise the RESP source is defaulted as
ECG.
Apnea Alarm Suffocation alarm occurs when the time of zero RESP rate has reached this
time scale, the alarm will be set off.
Resp Alarm Click and open the dialog of RESP alarm configuration.
Resp Lead Select the calculation methods of RESP lead, and options are RA-LL,

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RA-LA, RL-LA and RL-LL.

 Resp Alarm

Adjust alarm Select this option to enter the configuration of alarm limits; conduct the
configurations by turning the trim knob to select high or low limits and exit by selecting
〈EXIT〉.The upper part is the high limit and the lower one is the low limit.
RESP alarm Select <ON> to enable RESP over limit alarm; select <OFF> to disable
RESP over limit alarm.

5.2.5 Maintenance and Cleaning

No special operation demanded. Please refer to chapter 5.1.8.

5.3 Measurement of SpO 2/Pulse

5.3.1 Principles of Measuring

The measurement of degree of blood oxygen saturation (also known as pulse oxygen
saturation, usually shortened as SpO2) adopts the principles of light spectra and volume
tracing. The LED emits lights with two specific bandwidths, which are selectively
absorbed by hemoferrum and desoxyhemoglobin. The optical receptor measures the
changes in the light intensity after the light passes the capillary network and estimates the
ratio of hemoferrum and the total hemoglobin.
hemoferrum
Degree of pulse oxygen saturation %= ×100%
hemoferrum + desoxyhemoglobin

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The sensor measurement wavelengths are nominally 660nm for the Red LED and
940nm for infrared LED.
Abnormal hemoglobin, carboxyhemoglobin, oxidative hemoglobin are not directly
measured, for they are not the affecting factors in the measurement of SpO2
Monitor adopts FFT filter and signal correlation techniques to deal with SpO2 module’s
pulse waveform signals. Before the measurement of SpO2, the noise produced in the false
trace is smoothed so as to the eliminate disturbance in the measurement of saturation. In
case of weak blood pulse, the noise produced by some confinements of electrical
properties is greatly reduced.
The monitor is designed for measurement and recording of functional saturation.
When you use Masimo SpO2 module, the Perfusion Index (PI) and Pleth Variability
Index (PVI) can be measured and displayed on the screen.
 Perfusion index (PI): PI is a value that indicates arterial pulse signal strength as the
percentage of pulsatile signal to non-pulsatile signal. The perfusion index allows
clinicians to place sensors on optimal sites.
 Pleth Variability Index (PVI): PVI is a measure of peripheral perfusion changes
secondary to respiration, or the PI amplitude modulation over a respiration, and can be
closely related to intrathoracic pressure changes.

5.3.2 Preparatory Steps before the Measurement of SpO2/Pulse

1) Plug the SpO2 sensor cable into the SpO2 socket of the monitor.
2) Put the SpO2 sensor onto the finger of the patient, and the screen should display SpO2
waveforms, and the SpO2 value and pulse rate should be calculated.
3) Set up the parameters relevant to SpO2 and pulse monitoring.

5.3.3 Connecting to Patient and Monitor

Plug the SpO2 sensor cable into the socket marked with SpO2, then put the sensor onto
the finger of the patient, as shown in Fig. 5-3-3.

Fig. 5-3-3 Connection of SpO2 sensor with the patient

After the SpO2 sensor is connected to the patient, the screen shall display SpO2

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waveforms and then it shall calculate the SpO2 value and pulse rate value.

Caution: In case it is necessary to add a clip to fix the fingertip sensor, the cable
instead of the sensor itself should be clipped. Please note that the cable of sensor
should not be pulled with force.

 Note: Frequent movements of the sensor may result in errors in the readings of
the monitor.

Warning: In case NIBP and SpO2 are measured at the same time, please do not

place the SpO2 sensor and the NIBP cuff on the same end of the limb, for the
measurement of NIBP will block blood flow, affecting the measurement of SpO2.

 Warning: Do not conduct SpO2 measurement on the finger smeared with

fingernail oil, otherwise unreliable measurement results might be produced.

 Note: When using SpO2 sensor, care should be taken to shield external light
sources, such as light of thermo therapy or ultraviolet heating light, otherwise the
measurements may be disturbed. Under such conditions as shock, hypothermia,
anemia or the use of blood vessel-activating drugs, and with the existence of such
substances as carboxyhemoglobin, methemoglobin, methylene blue the result of the
SpO2 measurement will be possibly not accurate.

 Note:
 Make sure the nail faces to the light window.
 The wire should be on the backside of the hand.
 SpO2 waveform is not proportional to the pulse volume.

 Warning: Do not use the sterile supplied SpO2 sensors if the packing or the
sensor is damaged and return them to the vendor.

 Warning: Prolonged and continuous monitoring may increase jeopardy of

unexpected change of dermal condition such as abnormal sensitivity, rubescence,
vesicle, repressive putrescence, and so on. It is especially important to check the
sensor placement of neonate and patient of poor perfusion or immature dermogram
by light collimation and proper attaching strictly according to changes of the skin.
Check per 2～3 hours the sensor placement and move it when the skin deteriorates.
More frequent examinations may be required for different patients.

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5.3.4 Setup of SpO2/Pulse parameters

Beep Volume Select the BEEP volume and options are Off, 1, 2 and 3. Once an option
is selected, a testing beep will be produced.
HR Source Select the option of HR source, and options are AUTO, ECG and PLETH.
When selecting AUTO, the HR source is ECG with the priority; and if there is no current
ECG, the system automatically derives HR from SpO2.
Scan Speed Select the scanning speed of the ECG waveform, and options are 12.5mm/s,
25mm/s and 50mm/s.
Alarm Setup Click and open the dialog of SpO2 alarm configuration.
Average Time Select the average time for SpO2. The shorter the averaging time is, the
quicker the monitor responds to the change in the patient’s oxygen saturation level. （It is
invalid while use Nellcor SpO2 module）.
SpO2 mode Select the response time mode for SpO2, and options are Common mode
and Fast mode. It is valid only use the Nellcor SpO2 module.
 When you use Masimo SpO2 module, the below settings will be displayed.
FastSat The FastSat mode is clinically applicable during procedures when detecting
rapid changes in oxygen saturation is paramount such as induction, intubation and sleep
studies. You can select On or Off to enable or disable the FastSat mode.
Sensitivity Select the sensitivity level of Masimo SpO2 module according to use
condition, the options are Max, Normal and Apod. The Apod mode is the least sensitive
in picking up a reading on patients with low perfusion but has the best detection for
probe-off conditions. The Apod mode is useful for patients that are at particular risk of the
sensor becoming detached (pediatric, combative, etc.)

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Wave mode Select whether Resp wave includes in the SpO2 wave or not, the options are
Resp filter and Resp Inclu.

 Alarm Setup

Adjust alarm Select this option to enter the configuration of alarm limits; conduct
the configurations by turning the trim knob to select high and low limits and exit by
selecting 〈EXIT〉. The upper part is the high limit and the lower one is the low limit.
SpO2 alarm Select <ON> to enable SpO2 over limit alarm; select <OFF> to disable
SpO2 over limit alarm.
PR alarm Select <ON> to enable PR over limit alarm; select <OFF> to disable PR
over limit alarm.
 When you use Masimo SpO2 module, the below settings will be displayed.
Delay Time Select the delay time in the alarms as required in the options. If you select
a delay time, when the SpO2 value is within the threshold of alarm limit, it will not trigger
the alarm until reaching the delay time.
Threshold Select the threshold of the alarm limit.

5.3.5 Signal strength prompt

The signal strength prompt is used to indicate if the SpO2 signal strength measured is
adequacy.

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Prompt Description
Weak Signal The invalidation weak signal
* The low intensity signal
** The medium intensity signal
*** The high intensity signal

5.3.6 Measurement Limitation

If you doubt the SpO2 measurements, check the patient’s vital signs first, then check the
monitor and SpO2 sensor. The following factors may influence the accuracy of
measurements:
——Incorrect sensor application or use;
——Significant levels of dysfunctional hemoglobins. (such as carboxyhemoglobin or
methemoglobin);
——Intravascular dys such as indocyanine green or methylene blue;
——Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by covering
the sensor with a dark or opaque material)
——Excessive patient movement;
——Venous pulsations;
——Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line.
——Low perfusion;
——Electromagnetic interference, such as MRI device;
——Electrosurgical units.
Loss of pulse signal can occur in any of the following situation:
——The sensor is too tight;
——There is excessive illumination from light sources such as a surgical lamp, a
brilirubin lamp, or sunlight;
——A blood pressure cuff is inflated on the same extremity as the one with a SpO2
sensor attached;
——The patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia;
——There is arterial occlusion proximal to the sensor.
——The patient is in cardiac arrest or is in shock.

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5.3.7 Masimo Information

 Masimo Patents:
This device is covered under one or more of the following U.S.A. patents: 5,758,644,
5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975 and other applicable patents listed
at: www.masimo.com/patents.htm.

 No Implied License：
Possession or purchase of this device does not convey any express or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device, fall within the scope of one or more of the patents relating to this device.

5.3.8 Nellcor Information

This is the trademark of Nellcor Puritan Bennett Inc.

5.3.9 Maintenance and Cleaning

 Warning:
 Do not sterilize by irradiation, steam, or ethylene oxide.
 Do not subject the sensor to autoclaving.
 Do not immerse the sensor into any liquid.
 Do not use any sensor or cable that may be damaged or deteriorated.

 Note: When disposing the disposable SpO2 probe or useless SpO2 probe, please
observe all local, state, and federal regulations that relate to the disposal of this
products or similar products.

For reusable SpO2 sensor

Please unplug the sensor from the monitor before cleaning or disinfection.
Clean or disinfect the sensor before attaching to a new patient.

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 Cleaning:
Use a piece of clean cloth moistened in water or mild soap solution to clean the sensor
and patient contact surfaces.
 Disinfection:
Use a piece of clean cloth to wipe the sensor and patient contact surfaces with a 10%
bleach solution or 70% isopropyl alcohol, clean with clear water and wipe it dry.

5.4 Measurement of TEMP

5.4.1 Brief Introduction to Measurement of TEMP

Monitor measures TEMP with TEMP sensors. The TEMP module of Monitor uses
TEMP cable compatible with YSI-400. The minimum time to get accurate temperature
measuring value is 3 minutes.

5.4.2 Preparatory Steps of the Measurement of TEMP

1) Plug the TEMP cables into the TEMP sockets of the monitor.
2) Place the TEMP sensors on body of patient and the screen will show the value of
TEMP measurement.
3) Set the parameters relevant to TEMP.

5.4.3 Connecting Patient and Monitor

Plug the TEMP cable into the sockets marked with TEMP (either of TEMP1 and
TEMP2), and then stick the TEMP sensor securely onto the body of patient.

Caution: The TEMP sensor and cables should be handled with care. When not in
use, the sensor and the cable should be rounded into loose ring shape.

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5.4.4 Setup of TEMP Parameters

Unit Select the unit of TEMP, and options are ℃ and ℉.

T1 Label Select the labeling name for TEMP 1, and options are T1, Eso, Naso, Tymp,
Rect, Blad and Skin.
T2 Label Select the labeling name for TEMP 2,and options are T2, Eso, Naso, Tymp,
Rect, Blad and Skin.

Label Meanings Label Meanings

Eso Esophageal temperature Rect Rectal temperature
Naso Nasopharyngeal temperature Blad Bladder temperature
Tymp Tympanic temperature Skin Skin temperature

Alarm Setup Click and open the dialog of configuration for TEMP alarm.

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Adjust alarm Select this option to enter the configuration of alarm limits; conduct the
configurations by turning the trim knob to select high or low limits and exit by selecting
〈EXIT〉. The upper part is the high limit and the lower one is the low limit.
T1 alarm Select <ON> to enable T1 over limit alarm; select <OFF> to disable T1 over
limit alarm.
T2 alarm Select <ON> to enable T2 over limit alarm; select <OFF> to disable T2 over
limit alarm.

5.4.5 Maintenance and Cleaning

Reusable temp probes
1. The temp probe should not be heated above 100℃. It should only be subjected briefly
to temperatures between 80℃ and 100℃.
2. Only detergents containing no alcohol can be used for disinfection.
3. The rectal probes should be used, if possible, in conjunction with a protective rubber
cover.
 Cleaning:
Use a piece of clean cloth moistened in water or mild soap solution to clean the probe.
 Disinfection:
Use a piece of clean cloth to wipe the surface of the cable with 70% isopropyl alcohol,
a 10% bleach solution or 2% Cidex®, clean with clear water and wipe it dry.

 Warning: Disposable TEMP probes must not be re-sterilized or reused.

 Note: For protecting environment, the disposable TEMP probe must be recycled
or disposed of properly.

 Disposal Note: Should the TEMP probe become damaged beyond repair, or for
some reason its useful life is considered to be at an end, please observe all local, state,
and federal regulations that relate to the disposal of this products or similar
products.

 Warning: The calibration of temperature measurement is necessary for every

two years (or as frequently as dictated by your Hospital Procedures Policy). When
you need calibrate the temperature, contact the manufacture please.

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 Note: The self-test of the temperature measurement is performed automatically

once every 10 minutes during the monitoring. The test procedure lasts about one
second and does not affect the normal measurement of the temperature monitoring.

 Note: If Temperature to be measured beyond probe’s measuring range, over

measuring range alarm will display on the screen. Check out if probe is on the
corresponding patient body site, or change it to other site on the patient.

 Note: If “TEMP self-check error” display on the screen, it is possibly that

something is wrong with the temperature capture circuit, the operator should stop
using the monitor and contact with the company.

5.5 Measurement of NIBP

5.5.1 Brief Introduction to Measurement of NIBP

Monitor automatically conducts measurement of NIBP with the method of shockwave.
The method of shockwave indirectly estimates the systolic and diastolic pressures within
the blood vessels by measuring the change of the pressure within blood pressure cuff
along with the volume of the arteries and calculates the average pressure.
The measurement time of BP on a calm patient is less than 40s, and when each
measurement ends, the cuff automatically deflates to zero.
The monitor applies to any standards of the cuffs for neonate, child and adult (including
the cuffs used for arms and legs).
The monitor measures the blood pressure during the time of deflation. Monitor
automatically conducts the second and third inflation measurements in case during the
first inflation it is unable to measure the value of BP, and gives out the information for
measurement failures.
The longest cuff pressure maintaining duration is 120s (90s in neonate mode), and when
the time is exceeded, the air will be deflated automatically. The monitor has been designed
with hardware protection circuit regarding overpressure, errors of microprocessors, and
the occurrence of power failure.

5.5.2 Preparatory Steps of Measurement of NIBP

1) Plug the air hose of cuff into the NIBP socket of the monitor and tighten it clockwise
to ensure secure contact of the plug and the socket (Please note that the plug should be

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loosened by turning counterclockwise first before unplugging).

2) Tie the cuff on the arm of patient.
3) Set the parameters and modes relevant to NIBP.

 Note: Make sure that the air conduit connecting the blood pressure cuff and the
monitor is neither blocked nor tangled, and avoid compression or restriction of air
conduit.
5.5.3 Connecting to Patient and the Monitor
Plug the connector of air hose on cuff into the socket marked with NIBP and wrap the
cuff onto the arm of patient. Make sure the mark of Φ on the cuff is placed on the
femoral artery of the arm and the air hose should be below the cuff so as to ensure the air
hose is not snarled after coming out of the cuff. The white line on the cuff should be
within the range of “ ”, otherwise it will be necessary to replace it with a more
suitable cuff (smaller or bigger one). The cuff should be placed on the same plane with the
heart so as to prevent the errors in readings caused by the effects of hydrostatics of the
blood column between the heart and the cuff. If the position of the cuff is higher than the
plane of heart, the measured BP readings tend to be smaller; in case the position of the
cuff is lower than the plane of the heart, the measured BP readings tend to be higher.

 Note: The accuracy of measurement of BP depends on the suitability of the cuff.

Select the size of the cuff according to the size of the arm of patient. The width of the
cuff should be 40% of the circumference of the upper arm or 2/3 of the length of the
upper arm.

 Warning:
 You must not perform NIBP measurements on patients with sickle-cell
disease or under any condition that the skin is damaged or expecting to be
damaged.
 For a thrombasthemia patient, it is important to determine whether
measurement of the blood pressure shall be done automatically. The
determination should be based on the clinical evaluation.
 Prolonged non-invasive blood pressure measurements in Auto mode are
associated with purport, ischemia and neuropathy in the limb wearing the
cuff. When monitoring a patient, examine the extremities of the limb
frequently for normal color, warmth and sensitivity. If any abnormality is
observed, stop the blood pressure measurements.

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5.5.4 Setup of NIBP Parameters

Auto Time Configure the cycle intervals of BP measurement and options are 1min,
2min, 3min, 4min, 5min, 10min, 15min, 30min, 60min, 90min, 2Hour, 4Hour and
8Hour. During measurements, it cannot be altered.
Mode Configure the measurement mode of NIBP and options are Manual, Auto and
STAT.
If STAT mode is configured, after measurement, the system will be automatically
configured as the previous measurement mode. There is no STAT mode for neonatal. If
STAT is selected, the rapid measurement will be initiated once it is confirmed.

Object Objects of measurements shall be configured, and options are Adult, Children,
Neonatal and Hyperpiesia. The selection of objects of measurements during the
measuring process will terminate the ongoing measurement.
Init_Inflate Select an appropriate initial cuff inflation pressure according to patient
category and requirement.
Unit Select the unit for the NIBP measurement, and options are kPa and mmHg.
NIBP Alarm Click and open the dialog of alarm configuration of NIBP.
Leakage Click it and start air leakage test.
Vein Pun. You can use the NIBP cuff to cause sub-diastolic pressure, and block the
venous blood vessel to assist venous puncture. Select〈Vein Pun.〉, and set to a proper
value.
Start Pun. After you set a proper value for〈Vein Pun.〉, and select〈Start Pun.〉to start
it.

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 NIBP Alarm

Adjust alarm Select this option to enter the configuration of alarm limits; conduct the
configurations by turning the trim knob to select high or low limits and exit by selecting
〈EXIT〉. The upper part is the high limit and the lower one is the low limit.
Alarm Source Select the alarm source for NIBP parameters. When the selected parameter
or one of the parameter exceed alarm limit, the monitor will give out alarm signal. The
options are as follow:
〈S〉：Only Systolic pressure exceeds the alarm limit will trigger the alarm system.
〈D〉：Only Diastolic pressure exceeds the alarm limit will trigger the alarm system.
〈M〉：Only Mean pressure exceeds the alarm limit will trigger the alarm system.
〈S/M〉：Systolic pressure or mean pressure exceeds the alarm limit will trigger the alarm
system.
〈 D/M 〉： Mean pressure or diastolic pressure exceeds the alarm limit will trigger the
alarm system.
〈S/D〉：Systolic pressure or diastolic pressure exceeds the alarm limit will trigger the
alarm system.
〈S/D/M〉：Mean pressure, systolic pressure or diastolic pressure exceeds the alarm limit
will trigger the alarm system.
Alarm Switch Select <ON> to enable parameter over limit alarm; select <OFF> to
disable parameter over limit alarm.

5.5.5 Precautions during Measurement

 If the BP of the patient is above 180mmHg, <HYPER> measurement mode is
recommended.
 When using the STAT measurement or AUTO measurement, if the time duration is relatively

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long, care must be taken to check such abnormalities as purple spots, coldness and numbness at
the limb end. If there are such phenomena, the cuff should be relocated or the measurement of
NIBP should be halted. To neonate mode, STAT measurement is unavailable.
 The presence of factors that change the properties of the cardiovascular dynamics of
patient will adversely affect the measurement value of the monitor, and shock and
hypothermia will also affect the accuracy of the measurement.
 When the built-in main artery balloon pump is applied on the patient, the
measurement value of NIBP will be affected.
 For the limb that is on an intravenous drip or in a catheter insertion, or if the patient
is connected to the heart-lung machine, or the patient is experiencing shiver or
convulsions, the measurement of NIBP cannot be conducted.
 When errors occur in the measurement of NIBP, the error codes will appear in the
parameter display zone of the NIBP, and for the cause of the errors, please refer to
chapter 6.8.5.
 Measurement Limitations
Measurements are impossible with heart rate extremes of less than 40 bpm or greater
than 240 bpm, or if the patient is on a heart-lung machine.
The measurement may be inaccurate or impossible:
1) If a regular arterial pressure pulse is hard to detect
2) With cardiac arrhythmias
3) With excessive and continuous patient movement such as shivering or convulsions
4) With rapid blood pressure changes
5) With severe shock or hypothermia that reduces blood flow to the peripheries
6) With obesity, where a thick layer of fat surrounding a limb dampens the oscillations
coming from the artery
7) On an edematous extremity.

5.5.6 Periodic Check

 Calibration

 Warning: The calibration of the NIBP measurement is necessary for every two
years (of as frequently as dictated by your Hospital Procedures Policy). The
performance should be checked according to the following details.

Procedure of the Pressure Transducer Calibration:

1) Replace the cuff of the device with a rigid metal vessel with a capacity of 500 ml

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±5%.
2) Connect a calibrated reference manometer with an error less than 0.8 mmHg and a
ball pump by means of a T-piece connector and hoses to the pneumatic system.
3) Access the NIBP menu.
4) Turn the trim knob to the〈Manometer〉option and press. Then the NIBP module
has started performing calibration.
5) Inflate the pneumatic system to 0mmHg, 50mmHg and 200mmHg by ball pump
separately. The difference between the indicated pressure of the reference
manometer and the indicated pressure of the monitor will not exceed 3 mmHg.
Otherwise, please contact our customer service.
6) Press the button on front panel can stop the calibration.

Monitor Reference
NIBP Manometer
Hose

Ball Pump
Metal Vessel

Fig. 5-5-6 Diagram of NIBP calibration

 Air Leakage check

Procedure of the air leakage test:

1) Connect the cuff securely with the socket for NIBP air hole.
2) Wrap the cuff around the cylinder of an appropriate size.
3) Access the NIBP setup window.
4) Select the〈Leakage〉option and press. Then the prompt “Air Leakage test” will
appear on the NIBP parameter area indicating that the system has started
performing Air Leakage test.
5) The system will automatically inflate the pneumatic system to about 180mmHg.
6) After 20 seconds or so, the system will automatically open the deflating valve,
which marks the completion of an air leakage test.
7) If no error information displays on NIBP parameter area, it indicates that the

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airway is in good situation and no air leaks exist. However if the prompt “AIR
SYSTEM LEAK” appears in the place, it indicates that the airway may have air
leaks. In this case, the user should check for loose connection. After confirming
secure connections, the user should re-perform the air leakage test. If the failure
prompt still appears, please contact the manufacturer for repair.
8） Press the button on front panel can also stop the test.
Cylinder Metal Vessel
Monitor
NIBP Hose
Cuff

Fig. 5-5-7 Diagram of air leakage check

5.5.7 Maintenance and Cleaning

 Warning: Do not squeeze the rubber hose on the cuff. Do not allow liquid to
enter the connector socked at the front of the monitor. Do not wipe the inner part of
the connector socked when cleaning the monitor.

 Warning: If liquid is inadvertently splashed on the equipment or its accessories,

or may enter the conduit or inside the monitor, contact local customer service center.

 Warning: Disposable blood pressure cuff must not be re-sterilized or reused.

 Disposal Note: Should the blood pressure cuff become damaged beyond repair,
or for some reason its useful life is considered to be at an end, please observe all local,
state, and federal regulations that relate to the disposal of this products or similar
products.

For Reusable Blood Pressure Cuff:

 Cleaning:

1. Please clean the cuff termly.

2. Take down the cuff from the connector, take out the bladder from the cover of the cuff,
as the figure 5-5-8 shows.
3. Use a piece of clean cloth moistened in water or mild soap solution to clean the bladder
and the tube.
4. Clean the cover of the cuff with the mild soap solution.

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5. Dry the cover and the bladder. Roll the bladder and insert it into the large opening, as the figure
5-5-9 shows. Hold the hose and the cuff and shake the complete cuff until the bladder is in position. Put
the hose out through the small hole under the internal flap.

Roll the bladder and insert

it into the large opening

Take out the bladder

from this opening

Fig. 5-5-8 Take out the bladder Fig. 5-5-9 Insert the bladder

 Warning:
 Clean the bladder frequently, will cause the bladder scathed, except the
necessary, do not clean the bladder.
 Do not dry the bladder and cover with high temperature.
 If need the high level disinfecting, please selecting the disposable cuff.

5.6 Measurement of CO2 (Microstream, LoFlo)

Use the CO2 measurement to monitor the patient’s respiratory status and to control
patient ventilation.
5.6.1 Preparing to Measure CO2
1. Attaching the LoFlo Module Cable
To attach the LoFlo module cable, plug the cable into the CO2 socket on the left panel
of monitor by matching the key on the cable to the key on the connector.

Caution: To remove the module cable from the monitor, grasp the collar
surrounding the cable and pull up.

2. Attaching the Sample Cell

Follow these steps:
1) Insert the LoFlo sample cell into the LoFlo sample cell receptacle .A “click” will be
heard when the sample cell is properly inserted. (Fig.5-6-1, Fig.5-6-2)

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Fig.5-6-1

Fig.5-6-2

 Note:
 Inserting the sample cell into the receptacle automatically starts the
sampling pump. Removal of the sample cell turns the sample pump off.
 To remove the sample cell from the sample cell receptacle, press down on the
locking tab and pull the sample cell from the sample cell receptacle.

2) If the sampling pump fails to turn on, or runs intermittently, perform a “Zero”
procedure. (Refer to the chapter 5.6.3)
3) Ensure that the LoFlo module exhaust tube vents gases away from the module
environment.
4) Wait for the CO2 module to warm up.
The monitor will display the Sensor Warm Up message for approximately one
minute while the module warms up to operating temperature. The message disappears
when the module is ready for use.

 Note: Warm up time varies with ambient temperature of the module.

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5.6.2 Setup of CO2 parameters

Scan speed Select the scanning speed of RESP waveforms, and options are 6.25mm/s,
12.5mm/s and 25mm/s.
RESP source Select RESP source. And options are AUTO, ECG and EtCO2.
Unit Select the unit for CO2, and options are mmHg, % and kPa.
Resp Gain Select the gain of RESP waveform from ECG, and options are 1x, 2x and
4x.
Alarm setup Click and open the dialog of CO2 alarm.
CO2 setup Click and open the dialog of CO2 setup.
Wave Type Select display type of CO2 waveform. The options are Draw and Fill.
Back to Main Return to main screen.

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Gas Temp Select the temperature of gas. (Turn the trim knob with an increment or
decrement of 1℃)
Barometric Select the Atmospheric pressure. (Turn the trim knob with an increment
or decrement of 1mmHg)
EtCO2 Period Select the response time of EtCO2, the options are 1 breath, 10s and 20s.
Zero Gas Select the gas type of zeroing, the options are Air and N2.
Compensation Select the concentration of oxygen. (Turn the trim knob with an
increment or decrement of 1%)
Balance gas Select the balance gas type, the options are Air, N20 and Helium.
Anesthetic Select the concentration of balance gas. (Turn the trim knob with an
increment or decrement of 0.1%)
Zero Press the button to start zeroing. It is only valid when the system
detects that the module can be zeroed.

5.6.3 Zero
Zeroing allows the LoFlo module or CAPNOSTAT 5 sensor to adjust to the optical
characteristics, in order to obtain accurate readings. While zeroing is recommended the
first time a LoFlo module or CAPNOSTAT 5 sensor is connected to the unit, it is only
absolutely necessary when the message Zero Required is displayed.

 Warning:
 Always ensure that the sample cell is properly connected to the LoFlo module
before zeroing.

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 Always ensure that the CAPNOSTAT5 sensor is properly connected to the

airway adapter before zeroing.

Follow these steps:

1) Ensure that the nasal cannula or airway adapter is not connected to the patient or close
to any source of CO2 (including the patient's, your own, exhaled breath and ventilator
exhaust valves).
1) Press the〈Zero〉option in〈CO2 Setup〉menu. The unit zeroes the module and displays
the Zero In Progress message for approximately 15-20 seconds. The message disappears
upon completion of the zeroing.

 Note:
 Do not attempt zeroing for 20 seconds after removing the adapter or cannula
from the patient’s airway. This time allows any CO2 remaining in the adapter or
cannula to dissipate before zeroing.
 Do not attempt to zero the module while the adapter or cannula is in the
patient’s airway.
 Do not attempt zeroing if the temperature is not stable.
 Zeroing with CO2 in the adapter or cannula can lead to inaccurate
measurements or other error conditions. If you attempt zeroing while CO2
remains in the adapter or cannula, the time required to zero the module may be
increased.

5.6.4 Applying Microstream airway adapter or cannula

For intubated patients requiring an airway adapter: Install the airway adapter at the
proximal end of the circuit between the elbow and the ventilator Y section. (Fig.5-6-3)

Fig.5-6-3

For intubated patients with an integrated airway adapter in the breathing circuit:
Connect the male connector on the straight sample line to the female port on the airway
adapter. (Fig.5-6-4)

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Fig.5-6-4
For non-intubated patients: Place the nasal cannula onto the patient. (Fig.5-6-5)

Fig.5-6-5
For patients prone to mouth breathing use an oral-nasal cannula. Trim the oral sampling
tip if necessary to fit the patient. It should extend down past the teeth and be positioned in
the mouth opening. Remove the cannula from the patient if the tip needs to be trimmed.
(Fig.5-6-6)

Fig.5-6-6

For nasal or oral-nasal cannulas with oxygen delivery, place the cannula on the patient
as shown then attach the oxygen supply tubing to the oxygen delivery system and set the
prescribed oxygen flow.

Warning: Always connect the airway adapter to the sensor before inserting the

airway adapter into the breathing circuit. In reverse, always remove the airway
adapter from the breathing circuit before removing the sensor.

Caution: Always disconnect the cannula, airway adapter or sample line from
the sensor when not in use.

5.6.5 Removing Exhaust Gases from the System

 Warning: When using the microstream CO2 measurement on patients who

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are receiving or have recently received anesthetics, connect the outlet to a scavenging
system, or to the anesthesia machine/ventilator, to avoid exposing medical staff to
anesthetics.

Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the
microstream sensor at the outlet connector.

5.6.6 Safety considerations

 Warning：
 Do not use in the presence of flammable anesthetics or other flammable gasses.
Use of the LoFlo Module in such environment may present an explosion hazard.
 Electrical Shock Hazard: Always disconnect the LoFlo Module before cleaning.
Do not use if it appears to have been damaged. Refer servicing to qualified
service personnel.
 Do not position the sensor cables or tubing in any manner that may cause
entanglement or strangulation.
 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use
cannula kits and on-airway adapters may compromise functionality and system
performance leading to a user or patient hazard. Performance is not guaranteed
if an item labeled as single patient use is reused.
 Inspect the microstream on- airway adapters, microstream sampling kits and
CO2 airway adapters for damage prior to use. Do not use the microstream on-
airway adapters, microstream sampling kits and CO2 airway adapters if they
appear to be damaged or broken.
 Replace the microstream on- airway adapters, microstream sampling kits and
CO2 airway adapters if excessive secretions are observed.
 Monitor the CO2 waveform (Capnogram). If you see changes or abnormal
appearance check the airway adapters and the sampling line. Replace it if needed.
 Do not operate the LoFlo Module when it is wet or has exterior condensation.
 Do not apply excessive tension to any cable.
 Do not use device on patients that can not tolerate the withdrawal of 50
ml/min±10 ml/min from the airway or patients that can not tolerate the added
dead space to the airway.
 Do not connect the exhaust tube to the ventilator circuit.

Caution:
 Use only accessories provided by manufacturer.

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 Do not sterilize or immerse the LoFlo Module in liquids.

 Do not clean the LoFlo Module and accessories except as directed in this manual.
 Remove the LoFlo sampling kit sample cell from the receptacle when not in use.
 Do not stick appendage into sample receptacle.
 Always insert sample cell before inserting the on-airway adapter into the
ventilated circuit
 Always remove the on-airway adapter from the ventilated circuit before
removing the sample cell.

 Note:
 This product and its accessories are latex free.
 After the life cycle of the LoFlo Module and its accessories have been met,
disposal should be accomplished following national and local requirements.
 Nitrous oxide, elevated levels of oxygen and helium can influence the CO2
measurement. Please setup gas compensation according to actual state.
 Barometric pressure compensation is required to meet the stated accuracy of the
LoFlo Module.

5.7 Measurement of CO2(Mainstream, CAPNOSTAT5)

5.7.1 Preparing to Measure CO2

1. Attaching the CAPNOSTAT 5 sensor cable
To attach the CAPNOSTAT 5 sensor cable, plug the cable into CO2 socket on the left
panel of monitor by matching the key on the cable to the key on the connector.

Caution: To remove the sensor cable from the monitor, grasp the collar
surrounding the cable and pull up.

2. Selecting a mainstream airway adapter

Select an airway adapter based on the patient's size, ET tube diameter and monitoring
situation. For more information refer to the following table or contact manufacturer.

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3. Attaching the airway adapter to the CAPNOSTAT 5 sensor

Before attaching the airway adapter to the CAPNOSTAT 5 sensor, verify that the
airway adapter windows are clean and dry. Clean or replace the adapter if necessary.
Follow these steps:
1) Align the arrow on the bottom of the airway adapter with the arrow on the bottom of
the sensor.
2) Press the sensor and airway adapter together until they click.
3) Wait for the airway adapter and sensor to warm up.
The monitor will display the Sensor Warm Up message for approximately one minute
while the sensor and adapter warm to operating temperature. The message disappears
when the sensor is ready for use.

 Note: Warm up time varies with ambient temperature of the module.

4. Zero
Please refer to chapter 5.6.3
5. Attaching the airway adapter to the airway circuit
After zeroing, attach the airway adapter to the airway circuit as follow.(Fig.5-7-1)

Fig.5-7-1
6. Ensure the airway air-proof and ready to measure

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5.7.2 Setup of CO2 parameter

Please refer to chapter 5.6.2.

5.7.3 Zero
Please refer to chapter 5.6.3.

5.7.4 Safety considerations

 Warning：
 Do not use in the presence of flammable anesthetics or other flammable gasses.
Use of the CAPNOSTAT5 sensor in such environment may present an explosion
hazard.
 Electrical Shock Hazard: Always disconnect the CAPNOSTAT5 sensor before
cleaning. Do not use if it appears to have been damaged. Refer servicing to
qualified service personnel.
 Do not position the sensor cables or tubing in any manner that may cause
entanglement or strangulation.
 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2
airway adapters may compromise functionality and system performance leading
to a user or patient hazard. Performance is not guaranteed if an item labeled as
single patient use is reused.
 Inspect the CO2 airway adapters for damage prior to use. Do not use the CO2
airway adapters if they appear to be damaged or broken.
 Replace the CO2 airway adapters if excessive secretions are observed.
 If the CO2 waveform (Capnogram) appears abnormal, inspect the CO2 airway
adapters and replace if needed.
 Monitor the CO2 waveform (Capnogram) for elevated baseline. Elevated baseline
can be caused by sensor or patient problems.
 Periodically check the CAPNOSTAT5 sensor and tubing for excessive moisture
or secretion buildup.
 Do not operate the CAPNOSTAT5 sensor when it is wet or has exterior
condensation.

Caution:
 Use only accessories provided by manufacturer.
 Do not sterilize or immerse the CAPNOSTAT5 sensor in liquids.
 Do not clean the CAPNOSTAT5 sensor and accessories except as directed in this
manual.

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 It is recommended that the CO2 sensor be removed from the circuit whenever an
aerosolized medication is delivered. This is due to the increased viscosity of the
medications which may contaminate the sensor windows, causing the sensor to
fail prematurely.
 Do not apply excessive tension to the CAPNOSTAT5 sensor cable.

 Note:
 This product and its accessories are latex free.
 After the life cycle of the CAPNOSTAT5 sensor and its accessories have been met,
disposal should be accomplished following national and local requirements.
 Nitrous oxide, elevated levels of oxygen and helium can influence the CO2
measurement. Please setup gas compensation according to actual state.
 Barometric pressure compensation is required to meet the stated accuracy of the
CAPNOSTAT5 sensor.
 Do not place the combined CO2 sensor between the ET tube and the elbow
(pediatric or adult circuit), as this may allow patient secretions to block the
adapter windows.
 Position the combined CO2 sensor with its windows in a vertical and not a
horizontal position: this helps keep patient secretions from pooling on the
windows.

5.7.5 Maintenance and cleaning

 For CAPNOSTAT 5 Sensor and LoFlo Module
The outside of the module or sensor may be cleaned and disinfected by wiping with
70% isopropyl alcohol, a 10% bleach solution, or mild soap. After cleaning, wipe with a
clean, water-dampened cloth to rinse. Dry before use.
 For Reusable Airway Adapters
Reusable airway adapters may be cleaned by rinsing in a warm soapy solution, followed
by soaking in a liquid disinfectant such as 70% isopropyl alcohol, a 10% bleach solution,
Cidex® or System 1® (refer to the disinfectant manufacturer's instructions for use).
Adapters should then be rinsed with sterile water and dried.
Reusable airway adapters may also be pasteurized or autoclaved. Autoclave at 121 ℃
(250℉) for 20 minutes, unwrapped.
Before reusing the adapter, ensure the windows are dry and residue-free, and that the
adapter has not been damaged during handling or by the cleaning process.

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5.8 Measurement of AG

AG module is used to measure respiratory and anesthetic gases of a patient during

anesthesia, including CO2, N2O, O2, Halothane, Isoflurane, Enflurane, Sevoflurane and
Desflurane. It is applicable for adult, pediatric and infant patients.
There are two methods for measuring anesthetic gas in the patient’s airway:
 Mainstream: Uses a AG sensor attached to an airway adapter directly inserted into the
patient’s breathing system.
 Sidestream: Takes a sample of the respiratory gas with a constant sample flow from
the patient’s airway and analyzes it with the AG module.

5.8.1 Preparatory Steps for Measurement of AG

 Mainstream AG sensor
1. Plug the AG sensor connector into the AG connector on the monitor.
2. Attach AG sensor on the AG airway adapter. Shown as follows:

3.A green LED indicates that the AG sensor is ready for use. A blue LED indicates that
may measurement of anesthetic gases.

4. Connect the 15 mm male connector of AG airway adapter to the breathing

circuit Y-piece, and connect the 15mm female connector of AG airway
adapter to the patient’s endotracheal tube.

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Female connector
Male connector

Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s

endotracheal tube and the AG sensor. Placing an HME in front of the AG sensor protects
the airway adapter from secretions and effects of water vapor and eliminates the need of
changing the adapter. It allows free positioning of the AG sensor as well.

5. Unless the AG sensor is protected with an HME always position the AG sensor with the
indicating LED pointing upwards

 Pre-use Check
1 Check the reading on the monitor is correct or not before connecting the airway
adapter to the breathing circuit.
2 Always verify gas readings and waveforms on the monitor before connecting the
airway adapter to the patient circuit.
3 Perform the tightness check of the patient circuit with the AG sensor snapped on the
AG airway adapter.

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The state of the LED on the AG sensor:

Indication Status
Steady green light System OK
Blinking green light Zeroing in progress

Steady blue light 1) Anesthetic agent present

Steady red light Sensor error
Blinking red light Check airway adapter
Note 1: Valid for IRMA multi-gas sensors only.

 Sidestream AG module
1) Connect the AG module cable into the CO2/AG socket on the left panel of the monitor..
2) Connect a Nomoline sampling line to the inlet port of the AG module.

Inlet port

Sampling line

3) Connect the gas sample exhaust port to a scavenging system or return the gas to the
patient circuit.
4) Power up the patient monitor.
5) A green LED indicates that the AG module is ready for use.
6) Perform a pre-use check:
① Connect the sampling line to the inlet port of the AG module.
② Check that the AG module shows a steady green light (indicating that the system is
OK)
③ For AG module with O2 option fitted: Check that the O2 reading on the monitor is
correct (21%).
④ Breathe into the sampling line and check that valid CO2 waveforms and values are
displayed on the monitor.
⑤ Occlude the sampling line with a fingertip and wait for 10 seconds.
⑥ Check that an occlusion alarm is displayed and that the AG module shows a flashing
red light.
⑦ If applicable: Perform a tightness check of the patient circuit with the sampling line
attached.
The state of the LED on the AG module：

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Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line

5.8.2 Setup of AG parameters

AA type Select the types of anesthetic gas, and options are AA, HAL, ENF, ISO, SEV
and DES. After the monitor is turn on, if no AA types are configured, there will be a
technical alarm prompting the configuration of AA and need to designate a kind of
anesthetic gas. Considering safety, the configuration will not be saved after the monitor is
switched off.
Label Meanings Label Meanings
AA Anesthetic agent ISO Isoflurane
HAL Halothane SEV Sevoflurane
ENF Enflurane DES Desflurane
Gas zero Conduct zero calibration on anesthesia gas module. Press this button, the
following dialog will pop up. Select 〈 OK 〉 to conduct zero-calibration operation. If
〈Cancel〉is selected, the zero-calibration will not be implemented.

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 Note: The zero-calibration of Gas is only valid on the AG module of PHASEIN

Company.

O2 Module Turn on or turn off O2 module .When choose ON, parameters of O2 appear
on the screen while when choose OFF parameters of O2 disappear.
Auto Color Select On or Off to enable or disable the auto color function for the gas.
Operate Mode Select the operate mode of the AG module, the options are Sleep Mode,
Work Mode and Self Test.
Alarm Setup Click and open the dialog of anesthetic gas.

 AA alarm Click and open the dialog of AA alarm.

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Adjust alarm Select this option to enter the configuration of alarm limits; conduct the
configurations by turning the trim knob to select high and low limits and exit by selecting
〈EXIT〉.The upper part is the high limit and the lower one is the low limit.
EtAA alarm high limit, its configuration range is 0.0～ 30.0% continuously adjustable,
no lower than the low limit; the configuration range of EtAA alarm low limit is 0.0 ～
30.0% continuously adjustable, no higher than the high limit.
FiAA alarm high limit, its configuration range is 0.0 ～ 30.0% continuously adjustable,
no lower than the low limit; the configuration range of FiAA alarm low limit is 0.0 ～
30.0% continuously adjustable, no higher than the high limit.
Alarm Source Select the alarm source for AA parameters. When the selected parameter or
one of the parameter exceed alarm limit, the monitor will give out alarm signal. The
options are as follow:
〈EtAA〉：Only EtAA exceeds the alarm limit will trigger the alarm system.
〈FiAA〉：Only FiAA exceeds the alarm limit will trigger the alarm system.
：EtAA or FiAA exceeds the alarm limit will trigger the alarm system.
〈Et/Fi〉
Alarm Switch Select the switch of AA alarm.

 O2 alarm Click and open the dialog of O2 alarm.

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Adjust alarm Select this option to enter the configuration of alarm limits. conduct the
configurations by turning the trim knob to select high and low limits and exit by selecting
〈EXIT〉. The upper part is the high limit and the low one is the low limit.
FiO2 alarm high limit, its configuration range is 18～100% continuously adjustable, no
lower than the low limit; the configuration range of FiO2 alarm low limit is 18～ 100%
continuously adjustable, no higher than the high limit. FiO2 alarm cannot be switched
off, and when lower than 18% it will trigger high alarm.
EtO2 alarm high limit, its configuration range is 18～100% continuously adjustable, no
lower than the low limit; the configuration range of EtO2 alarm low limit is 18～ 100%
continuously adjustable, no higher than the high limit.
FiO2 alarm Select <ON> to enable FiO2 over limit alarm; select <OFF> to disable FiO 2
over limit alarm.
EtO2 alarm Select <ON> to enable EtO2 over limit alarm; select <OFF> to disable
EtO2 over limit alarm.

 Note: FiO2 alarm cannot be switched off.

 N2O alarm Click and open the dialog of N2O alarm.

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Adjust alarm Select this option to enter the configuration of alarm limits; conduct the
configurations by turning the trim knob to select high and low limits and exit by selecting
〈EXIT〉. The upper part is the high limit and the lower one is the low limit.
FiN2O alarm high limit, its configuration range is 0～100% continuously adjustable, no
lower than the low limit; the configuration range of FiN 2O alarm low limit is 0～100%
continuously adjustable, no higher than the high limit.
EtN2O alarm high limit, its configuration range is 0～100% continuously adjustable, no
lower than the low limit; the configuration range of EtN2O alarm low limit is 0～100%
continuously adjustable, no higher than the high limit.
Alarm Source Select the alarm source for N2O parameters. When the selected parameter
or one of the parameter exceed alarm limit, the monitor will give out alarm signal. The
options are as follow:
〈EtN2O〉：Only EtN2O exceeds the alarm limit will trigger the alarm system.
〈FiN2O〉：Only FiN2O exceeds the alarm limit will trigger the alarm system.
：EtN2O or FiN2O exceeds the alarm limit will trigger the alarm system.
〈Et/Fi〉
Alarm Switch Select the switch of N2O alarm.

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5.8.3 Safety Information

 Mainstream AG sensor

Warning:
 Disposable IRMA airway adapters shall not be reused. Reuse of the single use
adapter can cause cross infection.
 Used airway adapters shall be disposed of in accordance with local regulations
for medical waste.
 Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors
shall be disposed of in accordance with local regulations for batteries.
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter
adds 6 ml dead space to the patient circuit.
 Do not use the IRMA Infant airway adapter with adults as this may cause
excessive flow resistance.
 Measurements can be affected by mobile and RF communications equipment. It
should be assured that the IRMA probe is used in the electromagnetic environment
specified in this manual.
 Do not place the IRMA airway adapter between the endotracheal tube and an
elbow as this may allow patient secretions to block the adapter windows and result
in incorrect operation. Shown as follows:

 To keep secretions and moisture from pooling on the windows or oxygen sensor
port, always position the IRMA probe in a vertical position with the LED pointing
upwards. Shown as follows:

Measuring window

 Do not use the IRMA airway adapter with metered dose inhalers or nebulized
medications as this may affect the light transmission of the airway adapter windows.
 Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable
product and contains a caustic electrolyte and lead.

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 The IRMA sensor is intended only as an adjunct in patient assessment. It must

be used in conjunction with other assessments of clinical signs and symptoms.
 Replace the adapter if rainout/condensation occurs inside the airway adapter.
 Use only PHASEIN manufactured IRMA airway adapters.
 The IRMA sensor is not intended to be in patient contact.

Caution:
 Do not apply tension to the sensor cable.
 Do not operate the IRMA sensor outside the specified operating temperature
environment.
 Do not leave depleted oxygen sensors mounted in the IRMA sensor, even if the
probe is not in use
 Always disconnect the IRMA sensor from the monitor when not in use to
prolong the lifetime of IRMA sensor.
 The materials of patient breath tubing which is connected to the gas adapter,
can’t be anti-static and electric ones. Or it will be more dangerous when using HF
electrosurgical equipments.
 If error occurs in IRMA sensor, the indicating light will keep in red, and blink in
red means the sensor is check the airway adapter.
 The lifetime of the oxygen sensor is up to six months since its leaving factory. If it
cannot work normally or the parameter cannot be accurate measured due to
exceeding time limit, please replace the oxygen sensor timely.
 If the AG airway adapter is detached from the sensor, or low voltage of oxygen
sensor cell, or there is something wrong with the sensor, the prompting message may
pop up on one of above conditions

 Sidestream AG module

Warning:
 Use only Nomoline sampling lines manufactured by PHASEIN.
 The sidestream AG module must not be used with flammable anesthetic agents.
 Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
 Do not re-use disposable sampling lines.
 Do not lift the monitor by the sampling line as it could disconnect from the
monitor, casing the monitor to fall on the patient.
 Used disposable sampling lines shall be disposed of in accordance with local

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 Patient monitor user’s manual

regulations for medical waste.

 Do not use adult/pediatric type sampling line configurations with infants, as this
may add dead space to the patient circuit.
 Do not use infant type sampling line configurations with adults, as this may cause
excessive flow resistance.
 Do not use the sidestream AG module with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
 Check that the gas sample flow is not too high for the present patient category.
 Measurements can be affected by mobile and RF communications equipment.
Make sure that the sidestream AG module is used in the electromagnetic
environment specified in this manual.
 The sidestream AG module is intended only as an adjunct in patient assessment.
It must be used in conjunction with other assessments of clinical signs and
symptoms.
 Replace the sampling line if the sampling line input connector starts flashing red,
or a Nomoline occlusion message is displayed on the host monitor.
 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 sidestream AG module is not designed for MRI environments.
 During MRI scanning, the monitor must be placed outside the MRI suite.
 Operating high frequency electrosurgical equipment in the vicinity of the
monitor may produce interference and cause incorrect measurements.
 Too strong positive or negative pressure in the patient circuit might cause
incorrect readings and internal damage.
 Strong scavenging suction pressure might cause incorrect readings and internal
damage.
 Exhaust gases should be returned to the patient circuit or a scavenging system.
 Do not place the sidestream AG module in any position that might cause it to fall
on the patient.

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Caution:
 Do not apply tension to the sidestream AG module cable.
 Do not operate the sidestream AG module outside the specified operating
temperature environment.

5.8.4 Zeroing
 Mainstream AG sensor:
In order to ensure the accuracy of gas measurement, zero reference calibration should
be performed at regular intervals.
Under the following conditions, it is necessary to perform zero reference calibration:
——The measured reading occurs error;
——A“GAS CONC. OUT OF RANGE” alarm message is displayed（When using CO2
module, a “CO2 CONC. OUT OF RANGE” alarm message is displayed）;
——Airway adapter is replaced.
As following procedures:
1. Snap a new AG airway adapter onto the AG sensor. Ensure that the airway adapter is
not connected to the breath circuit of patient. The presence of ambient air (21% O2 and
0% CO2) in the AG airway adapter is very important.
2. Select 〈 Gas Zero 〉 in the AG parameter setting menu, this will start zeroing. The
monitor zeroes the module and displays the“Zero In Progress”message for about 5s.
3. There will be a blinking green light on the AG sensor LED during 5s while Zero
Reference calibration is in progress. Wait until the AG indicating lamp light on green
and the reading of oxygen on the screen is“21”.(When using CO2 module, the reading
of CO2 on the screen is“0”.) The message disappears upon completion of the zeroing.

Warning: Incorrect zero reference calibration will result in false gas readings.

Caution:
 User may only perform zero reference calibration under the instruction of the
technical personnel authorized by manufacturer.
 Ensure the AG sensor is running more than 15min before replacing a new airway
adapter. Please perform zero more than 2min after replacement.

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 Sidestream AG module:

The sidestream AG module needs to establish a zero reference level for the CO2, N2O
and anesthetic agent gas measurement. This zero calibration is here referred to as
"zeroing".
The sidestream AG module performs zeroing automatically by switching the gas
sampling from the respiratory circuit to ambient air. The automatic zeroing is performed
every 24 hours, and takes less than 3 seconds for CO2 module and less than 10 seconds for
AG module.
If the sidestream AG module is fitted with an oxygen sensor, the automatic zeroing
will also include room air calibration of the oxygen sensor.

Warning: Since a successful zeroing requires the presence of ambient air (21%
O2 and 0% CO2) in the AG module, ensure that the AG module is placed in a
well ventilated place. Avoid breathing near the sidestream AG module before or
during the zeroing procedure.

5.8.5 MAC Calculation

Minimum alveolar concentration (MAC) is a standard for comparing the potency of
inhalation anesthetics. The MAC value represents the alveolar concentration of an
anesthetic (at one atmosphere) that, in 50 percent of a tested population, prevents gross
muscular movement in response to a painful, standardized stimulus.
The MAC value may be calculated and displayed by using end-tidal (Et) gas
concentrations according to the following formula:

 Note:
 Altitude, patient age and other individual factors are not considered in the
formula above.
 ET gas concentrations for secondary agent (AA2) is only available for IRMA
AX+ sensors.

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5.8.6 Maintenance and disinfecting

 Mainstream AG sensor:
The IRMA sensor can be cleaned using a cloth moistened with maximum 70% ethanol
or maximum 70% isopropyl alcohol.
Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA sensor.

Caution:
 The IRMA airway adapters are non-sterile devices. Do not autoclave the devices
as this will damage them.
 Never sterilize or immerse the IRMA sensor in liquid.

 Sidestream AG module:
The ISA sidestream module should be cleaned on a regular basis.
Use a cloth moistened with max 70% ethanol or isopropyl alcohol to clean the module.
To prevent cleaning liquids and dust from entering the ISA sidestream module through
its inlet port, keep the Nomoline sampling line connected while cleaning the module.

Warning:
 The Nomoline sampling lines are non-sterile devices. To avoid damage, do not
autoclave any part of the sampling line.
 Never sterilize or immerse the ISA sidestream module in liquid.

Replacement of sampling line

The Nomoline sampling line is non-reusable.
Every two weeks or whenever "Sampling line clogged" appears, whichever comes first,
the Nomoline sampling line should be replaced.

5.8.7 Maintenance
The ISA sidestream module is permanently factory calibrated. The module’s stable
design, results in no routine calibrations. If you want to conduct a maintenance task for the
module, please send it to manufacturer.

5.8.8 PHASEIN Information

5.8.8.1 Patents
PHASEIN AB holds the following patents regarding products: SE519766; SE519779;
SE523461; SE524086. Other patents pending.

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5.8.8.2 Trademarks
PHASEIN IRMA™, PHASEIN ISA™, PHASEIN XTP™, Sigma Multigas
Technology™, LEGI™, Nomoline™, IRMA EZ Integrator™, PHASEIN GasMaster™
and ISA MaintenanceMaster™ are trademarks of PHASEIN AB.

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Chapter 6 Alarm
This chapter gives general information about the alarm and corresponding remedies.

 Note: The equipment generates all the auditory and visual alarms through
speaker, LED and screen.

6.1 Alarm Category and level

There are two kinds of alarms, defined as physiological alarm and technical alarm.
Physiological alarms refer to those alarms triggered by patient’s physiological situation
which could be considered dangerous to his or her life, such as SpO2 exceeding alarm
limit (parameter alarms). Technical alarms refer to system failure, which can make certain
monitoring process technically impossible or make monitoring result unbelievable.
General alarm belongs to those situations that cannot be categorized into these two cases
but still need to pay some attention. Each alarm, either technical or physiological, has its
own priority.
Alarms in the monitor are divided into three priorities, that is: high level, medium level
and low level.
 High level alarm indicates the patient’s life is in danger. It is the most serious
alarm.
 Medium level alarm means serious warning.
 Low level alarm is a general warning.
Only alarm level of parameters exceeding limits alarm can be modified by the user, the
other alarm level of physiological and technical alarms are preset by the system and they
can not be changed by the user.

6.2 Alarm Modes

When alarm occurs, the monitor may raise the user’s attention in two ways, which are
auditory prompt, visual prompt and description. Visual prompt is given by alarm
indicating lamp and screen of the monitor, auditory prompt is given by speaker in the
device. Physiological alarm information is displayed in the Physiological Alarm area.
Most of technical alarm information is displayed in the Technical Alarm area. Technical
alarms related to NIBP measurement are displayed in the NIBP parameter area.

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The Physiological Alarm area is on the upmost right part of the screen. The Technical
Alarm area is to the left side of the Physiological Alarm area.
The alarm sound and visual display comply with clause 201.3.2 of the standard IEC
60601-1-8.

 Note: The concrete presentation of each alarm prompt is related to the alarm
priority.

 Alarm Sound
The high/medium/low-level alarms are indicated by the system in following different
audio ways:
Alarm level Audio prompt
Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”,
High which is triggered once every 10 seconds.
Medium Mode is “DO-DO-DO”, which is triggered once every 25 seconds.
Low Mode is “DO-”, which is triggered once every 25 seconds.

 Alarm Lamp light

The high/medium/low-level alarms are indicated by the system in following different
visual ways:
Alarm level Visual prompt
High Alarm indicating lamp flashes in red with 2 Hz.
Medium Alarm indicating lamp flashes in yellow with 0.5 Hz.
Low Alarm indicating lamp lights on in yellow.

 Screen Display
Physiological alarm: The parameter, which triggers the alarm, splashes in the frequency
of 2Hz on the screen. The physiological alarm area on the screen displays alarm message,
and red indicates high priority alarm, yellow indicates medium or low priority alarm.
When Technical alarm or General alarm occurs, the Technical alarm area displays alarm
message, red indicates high priority alarm, yellow indicates medium or low priority alarm,
cyan indicates general message.

 Note: When alarms of different priorities occur at the same time, the monitor
prompts the one of the highest priority.

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6.3 Alarm Setup

 Set Alarm volume

Step 1: Select <Alarm Volume> item in Menu: <MENU>  <Alarm Setup> 
< Alarm Volume >.
Step 2: Set < Alarm Volume > item to <Off>, <1>, <2>, <3>.
 Set alarm limits of physiological parameters
The alarm limit of each physiological parameter can be set in its menu, and they are
continuous in alarm range. For example:
ECG alarm setup:
Step 1: Select Menu <ECG>
Step 2: Configure the following parameters related to ECG alarm, <HR LO> and <HR
HI>.
Please refer to above operation for Methods of Alarm setup of the other parameters
It is important to set physiological alarm limits properly. The monitor can’t give
medicinal alarm prompt in clinical application with improper setting of physiological
alarm limit.
The physiological alarm occurs when the measurement exceeds the set parameter limits.
Please refer to above operation for Methods of alarm setup of the other parameters.
ECG Alarm configuration

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Alarm levels configuration

Alarm recording configuration

Alarm indication of physiological parameters

Audio: when alarm occurs, the system generates alarm sound to raise the user’s
attention (audio alarm can be disabled).
Visual: The parameter flashes on the display area of the screen and alarm LED lights.

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 Warning：The lower limit and the upper limit of parameter must be set based on
clinical practices and general clinical experiences.

 Note ： When parameter alarm level is off, alarm will be disabled, even if the
measurement results exceed the limits. Alarm indicating lamp in the front of the
monitor will alarm at the highest level, if different levels alarms coexist.

6.4 Alarm Cause

Alarm of the monitor includes:

1. Physiological Alarm
2. Technical Alarm
3. General Prompt
 Physiological Alarm
When the measuring value has exceeded the set parameter limit and its <ALM LEV>
is not <OFF>, the monitor alarms. The monitor wouldn’t alarm with absence of either
of the two conditions.
 Technical Alarm
Once system fault occurs, the monitor will alarm immediately and trigger
corresponding operations, such as stop displaying values and waveforms, erase the
last screen to avoid misleading. The screen displays more than one fault message by
alterative.
 General Prompt
Sometimes there are alarms similar to Technical Alarms but can be considered as
normally. The condition, which triggers this kind of alarm wouldn’t bring danger to
the patient.

6.5 Silence/Suspension

 SILENCE
Press the button and hold for 2 seconds can shut off all sounds until the
button is pressed again. When the system is in SILENCE status, any newly
generated alarm will cancel the SILENCE status and make the system back to normal
status.

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When in the SILENCE status, the icon will be displayed in the left upper of
the screen.
 SUSPENSION
Press the button once can close all audio and visual prompt and description about
all the physiological alarms and to make the system enter ALARM PAUSE status. The rest
seconds for alarm pause is displayed in the Physiological Alarm area. And the symbol
is displayed in the System Prompt area.

The time for Alarm Suspension is 2 minutes.

When in the PAUSE status, press the button again to restore the normal alarm
status. Besides, during PAUSE status, newly occurring technical alarm will cancel the
PAUSE status and the system will come back to the normal alarm status. The symbol
disappears, too.

 Note: Whether an alarm will be reset depends on the status of the alarm cause.
But by pressing button can permanently shut off audio sound of Lead Off or
Sensor Off alarms.

6.6 Parameter Alarm

You can check and set the parameters’ alarm limit in their menus or in the alarm setup
window in main setup menu.
If you want to set the alarm state of parameters, enter the machine maintenance state
please.
For the parameters whose alarm switch is set to ON, the alarm will be triggered when at
least one of them exceeds alarm limit. The following actions take place:
1. Alarm message displays on the screen as described in alarm mode;
2. The monitor beeps in its corresponding alarm class and volume;
3. If alarm recording is on, the recorder starts alarm recording at set interval.

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6.7 When an Alarm Occurs

 Note: When an alarm occurs, you should always check the patient’s condition
first.

Check the alarm message appeared on the screen. It is needed to identify the alarm and
act appropriately, according to the cause of the alarm.
1. Check the patient’s condition.
2. Identify which parameter is alarming or which kind of alarm it is.
3. Identify the cause of the alarm.
4. Silence the alarm, if necessary.
5. When cause of alarm has been over, check that the alarm is working properly.

6.8 Alarm Description and Prompt

6.8.1 ECG Alarm

Physiological Alarm:

Message Cause Alarm Level

HR too high HR measuring value is above the upper User-selectable
alarm limit
HR too low HR measuring value is below the lower User-selectable
alarm limit
Technical Alarm：

Message Cause Alarm Level

ECG RA LA LL V- LEAD ECG electrode fall off the skin or ECG
Low
OFF cables fall off the monitor
ECG electrode polarized ECG electrode polarized Low
ECG measurement failure or communication
ECG communication error Low
failure
HR alarm error Alarm failure Low

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 Patient monitor user’s manual

6.8.2 RESP Alarm

Physiological Alarm：

Message Cause Alarm Level

RR measuring value is above the upper alarm
RR too high User-Selectable
limit
RR measuring value is below the lower
RR too low User-Selectable
alarm limit
RESP Apnea No signal for breath in specific interval User-Selectable

Technical Alarm：

Message Cause Alarm Level

RR alarm error Alarm failure Low

6.8.3 SpO2 Alarm

Physiological Alarm：

Message Cause Alarm Level

SpO2 measuring value is above the upper Medium ,High
SpO2 too high
alarm limit User-Selectable
SpO2 measuring value is below the lower Medium ,High
SpO2 too low
alarm limit User-Selectable
PR measuring value is above the upper alarm
PR too high User-Selectable
limit
PR measuring value is below the lower alarm
PR too low User-Selectable
limit
Technical Alarm：

Message Cause Alarm Level

SpO2 sensor off SpO2 sensor may be disconnected from the
Low
patient or the monitor
SpO2 communication error SpO2 measurement failure or communication
Low
error
SpO2 alarm error Alarm failure Low
PR alarm error Alarm failure Low
SpO2 sensor failure SpO2 sensor failure Low
SpO2 pulse timeout Search pulse too long High

Prompt:

Message Cause Alarm Level

Search pulse SpO2 module is searching for pulse No alarm
Motion interference Patient movement too much. No alarm

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 Patient monitor user’s manual

Disconnected SpO2 sensor may be disconnected form the No alarm

monitor.

Technical Alarms (Masimo SpO2)

SpO2 Interference Detected SpO2 module detects the interference. Low
SpO2 No sensor Connected No SpO2 sensor connected Low
SpO2 No Cable No cable connected Low
SpO2 Sensor Calibrate SpO2 sensor calibrate Low
SpO2 has R wave SpO2 wave has R wave Low
SpO2 Defective Sensor SpO2 sensor is defective Low
SpO2 Too Much Ambient There are too much ambient light. Low
Light
SpO2 Low Signal IQ SpO2 signal IQ is low High
SpO2 Unrecognized Sensor SpO2 sensor is unrecognized. Low
SpO2 Processing Active SpO2 processing is active. Low
SpO2 No Tape SpO2 no tape Low
SpO2 Demo The monitor is at demo mode Low
SpO2 Sensor Fault SpO2 sensor has some fault Low
SpO2 Board Fault SpO2 board has some fault Low
SpO2 Low Perfusion SpO2 low perfusion Low
SpO2 Diagnostic Failure SpO2 diagnostic failure Low

Prompt:
Message Cause Alarm Level
Search pulse SpO2 module is searching for pulse No alarm
Motion interference Patient movement too much. No alarm
Disconnected SpO2 sensor may be disconnected form the No alarm
monitor.

6.8.4 TEMP Alarm

Physiological Alarm:

Message Cause Alarm Level

TEMP1 measuring value is above upper
TEMP1 too high User-Selectable
alarm limit
TEMP1 measuring value is below lower
TEMP1 too low User-Selectable
alarm limit
TEMP2 measuring value is above upper
TEMP2 too high User-Selectable
alarm limit

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TEMP2 measuring value is below lower

TEMP2 too low User-Selectable
alarm limit
Technical Alarm：

Message Cause Alarm Level

TEMP1 sensor off TEMP1 sensor may be disconnected from
Low
user or monitor
TEMP2 sensor off TEMP2 sensor may be disconnected from
Low
user or monitor
TMEP communication error TEMP measurement error or communication
Low
error
TMEP1 alarm error Alarm failure Low
TEMP2 alarm error Alarm failure Low
T1 over measuring range TEMP1 over measuring range Low

T1 below measuring range TEMP1 below measuring range Low

T2 over measuring range TEMP2 over measuring range Low

T2 below measuring range TEMP2 below measuring range Low

TEMP Self checking error TEMP calibration failure Low

6.8.5 NIBP Alarm

Physiological Alarm：
Message Cause Alarm Level
NIBP SYS measuring value is above upper
NIBP SYS too high User-Selectable
alarm limit
NIBP SYS measuring value is below lower
NIBP SYS too low User-Selectable
alarm limit
NIBP DIA measuring value is above upper
NIBP DIA too high User-Selectable
alarm limit
NIBP DIA measuring value is below lower
NIBP DIA too low User-Selectable
alarm limit
NIBP MAP measuring value is above upper
NIBP MAP too high User-Selectable
alarm limit
NIBP MAP measuring value is below lower
NIBP MAP too low User-Selectable
alarm limit

Technical Alarm 1(display in description area)：

Message Cause Alarm Level
NIBP measurement failure or
NIBP communication error Low
communication failure
NIBP SYS alarm error Alarm failure Low

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 Patient monitor user’s manual

NIBP DIA alarm error Alarm failure Low

NIBP MAP alarm error Alarm failure Low

Technical Alarm 2(display in description area below NIBP mean arterial pressure value):
Message Cause Alarm Level
SELF-TEST FAILED Transducer or other hardware failure. Low

a. Cuff is completely unwrapped.

LOOSE CUFF b. The cuff is not connected. Low
c. Adult cuff used in neonate mode.
AIR LEAK Air leak in pneumatics, hose, or cuff. Low
Unable to maintain stable cuff pressure, e.g.
AIR PRESSURE ERROR Low
kinked hose.

a. Very weak patient signal due to a loosely

WEAK SIGNAL wrapped cuff. Low
b. The pulse of patient is too weak.
Measurement range exceeds module
RANGE EXCEEDED Low
specification.

a. Too many retries due to interference of

motion artifact.
EXCESSIVE MOTION b. Signal is too noisy during measurement, Low
e.g. patient has severe tremor.
c. Irregular pulse rate, e.g. arrhythmia.
Cuff pressure exceeds the specified upper
OVERPRESSURE SENSED safety limit. Could be due to rapid squeezing Low
or bumping of cuff.
Large motion artifact that saturates the BP
SIGNAL SATURATED Low
amplifier’s amplitude handing capability.
Module reports Air Leakage failure while in
AIR SYSTEM LEAK Low
the Pneumatic Test mode.
SYSTEM FAILURE Module occurs abnormal processor event. Low
Measurement took more than 120 seconds in
TIME OUT Low
adult, 90 seconds in neonate mode.
CUFF TYPE ERR Neonate cuff used in adult mode. Low

Prompt (display in description area below NIBP mean arterial pressure value):
Message Cause Alarm Level
NIBP Resetting NIBP measurement module is resetting
Over Press Testing NIBP is testing Over-Pressure
No alarm
Manometer Testing NIBP is testing Manometer
Pneumatic Testing NIBP is testing Pneumatic

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6.8.6 CO2Alarm

Physiological Alarm:

Message Cause Alarm Level

EtCO2 Hi EtCO2 measuring value is above upper alarm User-Selectable
EtCO2 Lo EtCO2 measuring value is below lower alarm User-Selectable
FiCO2 Hi FiCO2 measuring value is above upper alarm User-Selectable
FiCO2 Lo FiCO2 measuring value is below lower alarm User-Selectable
Apnea No breath detected in the set period User-Selectable
Technical Alarm:

Message Cause Alarm Level

Sensor Over Temp Sensor over temperature. High
Sensor Faulty Sensor error High
Check Sampling Line Sampling line blockage or damage; Low
Sampling line is kinked or pinched;
Exhaust tube is blocked.
Zero Required Negative CO2 detected; the module needs to High
be zeroed.
CO2 Out of Range The calculated CO2 value is out of range. Low
Check adapter The adapter is removed from the module. Low
Sensor no initialized Sensor or module is not initialized Low

Prompt:

Message Cause Alarm Level

Zero in Progress Zeroing is in progress. No Alarm
Sensor Warm Up Module is warming up. No Alarm

6.8.7 AG alarm and promotion

Physiological alarm:
Message Cause Alarm Level
EtAA too high EtAA is above upper alarm limit
User-Selectable
EtAA too low EtAA is below lower alarm limit
FiAA too high FiAA is above upper alarm limit
User-Selectable
FiAA too low FiAA is below lower alarm limit
EtN2O too high EtN2O is above upper alarm limit
User-Selectable
EtN2O too low EtN2O is below lower alarm limit

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FiN2O too high FiN2O is above upper alarm limit

User-Selectable
FiN2O too low FiN2O is below lower alarm limit
EtO2 too high EtO2 is above upper alarm limit
User-Selectable
EtO2 too low EtO2 is below lower alarm limit
FiO2 too high FiO2 is above upper alarm limit
User-Selectable
FiO2 too low FiO2 is below lower alarm limit

Technical Alarm：
Message Cause Alarm Level
GAS communication error GAS module failure or communication error Medium
Airway adaptor of GAS module
Check Airway Adapter Medium
disconnected with sensor
Replace O2 sensor Oxygen sensor disconnected with module Medium
O2 sensor low Weak oxygen sensor signal Medium
GAS sensor error GAS sensor error Low
GAS CONC. Out of Range Measurement of GAS module over range Medium
Room Air Calibration Measurement of oxygen density is not
High
Required correct.
Sampling line is occluded or damaged;
Sampling line Clogged Medium
Sampling tube is kinked or pinched.
Sampling line disconnected with the AG
No sampling line Low
module.
O2 Sensor Err O2 Sensor error Low
The command of the last span calibration
Last Span Cal. command fail Low
failed.

Prompt messages:
Messages Cause Level
Span Cal. in progress Span calibration is in progress. No alarm
O2 Span Calibration Required The O2 span needs to be calibrated. No alarm
Mixed Agents More than one type of agent exist No alarm

6.8.8 System Alarm and Prompt

Technical Alarm
Message Cause Alarm Level
Battery failure Battery failure or no battery Low

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Battery low Voltage of battery is too low Medium

Key error Keyboard error Low
No paper in the recorder when recording or
Recorder error the recorder door is open or recorder is Low
absent
Prompt
Message Cause Alarm Level
Recording... Recorder is in printing operation No alarm

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Chapter 7 Recording
Monitor carries out the recording function by the built-in recorder.
 Alarm recording
Monitor provides the function of alarm trigger recording. To make alarm recording
available, Please keep <Alarm Record >of <Recorder setup> of <System setup> in
<Monitor setup> menu is ON, and adjust alarm level of alarm parameter to non-close. If
any monitoring parameter exceeds the limit and <Alarm Record> is ON, recorder will
print all monitoring parameter values in the alarm time. Moreover, if monitor alarms
continuously, recorder will print every two minutes.

 Auto recording
Monitor has the function of Auto recording. To make Auto recording available, user
can adjust <Record Interval> of <Recorder Setup> of <System Setup> in <Monitor
Setup> to a necessary interval time. All monitoring parameter values and waveforms will
be recorded automatically according to the determined period.

 Real-Time recording
Monitor has the function of real time recording. If button in the front panel has
been pressed over 2 seconds, the waveform and data of ECG and SpO2 can be recorded in
real time. If this key pressed again, real time recording will end. The lead ECG waveform
(determined by <Record Wave> in <Recorder Setup>) will be monitoring in emphasis,
when ECG waveforms are being recorded.

 Note: During real time recording, three waveforms can be recorded at the same
time. Users can configure the waveforms according to need. Please refer to chapter
4.2.1. Measurement parameter values of individual module have been recorded on
the top of waveforms.

Chapter 7-1
 Patient monitor user’s manual

Chapter 8 Other Functions

8.1 Nurse Call

Nurse Call is a function that the monitor will send signal to call nurse when the alarm
conditions destined are occurred.
The monitor has a nurse call output socket, connect the socket to the nurse call system
of the hospital by the nurse-call cable provided along with the monitor, the nurse call
function can be realized.
The nurse call function is valid when the following conditions are concurrent:
 The nurse call function is open.
 An alarm condition destined is occurred.
 The monitor is not in the state of alarm paused or system silence.

To set up nurse call function:

1. Select <MENU>→<Monitor>→<System Setup>→<Nurse Call>, and configuration
the following options:
Nurse call Select <ON> to enable nurse call function; select <OFF> to disable nurse
call function.
Phy trigger Select the Physiological alarm level that can trigger the nurse call action.
The options are OFF, Low, MED and High, and select <OFF> to disable
the trigger action.
Tech trigger Select the Technical alarm level that can trigger the nurse call action. The
options are OFF, Low, MED and High, and select <OFF> to disable the
trigger action.
2. Select <MENU>→ <Monitor>→<System Setup>→<Machine>, enter the password
(password is 125689) .
3. Enter the interface of Nurse call setup and configuration the following options:
Call mode Select the duration of nurse call signal and options are Pulsing and
Continuous.
Call type Select the type of nurse call. Select < N.C.> is normal Close, select < N.O.>
is normal on.

Chapter 8-1
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 Warning: The nurse call function should not be used as the primary patient
alarm inform source. It is necessary for combining the auditory and visual alarm
signal and the patient clinical feature and symptom as the primary information to
medical and nursing staff about the physiological condition of the patient.

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Chapter 9 Maintenance and Cleaning

9.1 System Check

An effective maintenance schedule should be established for your monitoring

equipment and reusable supplies. This should include inspection as well as general
clearing on a regular basis. The maintenance schedule must comply with the policies of
your institution’s infection control unit and/or biomedical department.
Check with your biomedical department to be sure preventive maintenance and
calibration has been done. The Service manual contains detailed information.
Before using the monitor, check the equipment following these guidelines:
 Check the equipment for obvious mechanical damage.
 Check all the outer cables, inserted modules and accessories for fraying or other
damage. Qualified service personnel should repair or replace damaged or
deteriorated cables.
 Check all the functions relevant to patient monitoring, make sure that the monitor
is in good condition.
If you find any damage on the monitor, stop using the monitor on patient, and contact
the biomedical engineer of the hospital or Manufacturer’s Customer Service immediately.

 Note: Refer to the User Maintenance Instruction for more comprehensive

checkout procedures.

The overall check of the monitor, including the safety check, should be performed only
by qualified personnel once every 6 to 12 month, and whenever the monitor is fixed up.
 Inspect the safety relevant labels for legibility.
 Verify that the device functions properly as described in the instructions for use.
 Test the protection earth resistance according IEC 60601-1:1995, Limit 0.1ohm.
 Test the earth leakage current according IEC 60601-1:1995, Limit: NC 500uA,
SFC 1000uA.
 Test the patient leakage current according IEC 60601-1:1995, Limit: 100uA(BF),
10uA(CF).
 Test the patient leakage current under single fault condition with mains voltage on
the applied part according IEC 60601-1:1995, Limit: 5mA(BF), 50uA(CF).

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The leakage current should never exceed the limit. The data should be recorded in an
equipment log. If the device is not functioning properly or fails any of the above tests, the
device has to be repaired.
The synchronism of the defibrillator should be checked by in the frequency described in
the hospital regulations. At least every 3 months, it should be checked by the biomedical
engineer of the hospital or qualified service technician.
All the checks that need to open the monitor should be performed by qualified service
technician. The safety and maintenance check can be conducted by persons from the
manufacturer. You can obtain the material about the customer service contract from the
local office.
The circuit diagrams, parts lists and calibration instructions of the patient monitor can
be provided by the manufacturer.

 Warning: If the hospital or agency that is responding to using the monitor does
not follow a satisfactory maintenance schedule, the monitor may become invalid, and
the human health may be endangered.

 Note: To ensure maximum battery life, please ensure that the battery is fully
charged when you are keeping the device in storage for an extended period of time,
and then take out the battery.

 Warning: Refer the battery replacement only to manufacturer’s service

technician.

9.2 Battery Maintenance

A rechargeable and maintenance-free battery is designed for Patient Monitor, which

enables continuous working when AC power off. Special maintenance is not necessary in
the normal situation. Please pay attention to the followings in using for more durable
usage and a better capability.
 Operate the patient monitor in the environment according to the instruction.
 Use AC power for the patient monitor when available.
 Recharge the battery sooner when it is off. The volume of battery will not be charged
to what it should be, when the battery has not been charged for a long time.
 If the monitor is not used for long time, the AC power should be plugged in until the

Chapter 9-2
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battery is fully recharged, then take out the battery, so that the service life of the battery
will not be shortened.
 Avoid exposed and sun shine.
 Avoid infrared and ultraviolet radiation.
 Avoid moist, dust and erosion from acid gas.
For Lithium ion battery:
A lithium ion battery needs at least two conditioning cycles when it is put into use for
the first time. A battery conditioning cycle is one complete, uninterrupted charge of the
battery, followed by a complete, uninterrupted discharge of the battery. A lithium ion
battery should be conditioned regularly to maintain its useful life. Condition a battery once
when it is used or stored for two months, or when its run time becomes noticeably shorter.
To condition a lithium ion battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring and measuring
procedures.
2. Place the lithium ion battery in need of conditioning into battery compartment of the
monitor.
3. Connect the monitor to the AC mains. Allow the battery to be charged uninterruptedly
for above 6 hours.
4. Remove the AC mains and allow the monitor to run from the battery until it shuts off.
5. Reconnect the monitor to the AC mains. Allow the battery to be charged uninterruptedly
for above 6 hours.
Now the battery is conditioned and the monitor can be returned to service.

9.3 General Cleaning

 Warning: Before cleaning the monitor or the sensors, make sure that the
equipment is switched off and disconnected from the power line.

The Patient Monitor must be kept dust-free.

Regular cleaning of the monitor shell and the screen is strongly recommended. Use only
non-caustic detergents such as soap and water to clean the monitor shell.
Please pay special attention to the following items:
1. Avoid using ammonia-based or acetone-based cleaners such as acetone.
2. Most cleaning agents must be diluted before use. Follow the manufacturer’s
directions carefully to avoid damaging the monitor.

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3. Don’t use the grinding material, such as steel wool etc.

4. Don’t let the cleaning agent enter into the chassis of the system.
5. Don’t leave the cleaning agents at any part of the equipment.

9.4 Cleaning Agents

Examples of disinfectants that can be used on the instrument casing are listed below:
 Diluted soap solution
 Diluted Ammonia Water
 Diluted Sodium Hypochlorite (Bleaching agent).

 Note: The diluted sodium hypochlorite from 500ppm (1:100 diluted bleaching
agent) to 5000ppm (1:10 bleaching agents) is very effective. The concentration of the
diluted sodium hypochlorite depends on how many organisms (blood, mucus) on the
surface of the chassis to be cleaned.

 Hydrogen Peroxide 3%
 Alcohol 70%
 Isopropyl alcohol 70%
The surface of patient monitor can be cleaned with hospital-grade ethanol and dried in
air or with crisp and clean cloth.
The manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in your
hospital for details.

9.5 Disinfection

To avoid extended damage to the equipment, disinfection is only recommended when

stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities
should be cleaned first.
Appropriate disinfection materials for ECG cable, SpO2 sensor, blood pressure cuff,
TEMP probe, CO2 sensor and AG sensor are introduced in the corresponding chapters
respectively.

 Warning: Do not use EtO gas or formaldehyde to disinfect the monitor.

Chapter 9-4
 Patient monitor user’s manual

Chapter 10 Accessories
This chapter lists the recommendation accessories used in this device.

 Warning: The accessories listed below are specified to be used in this device. The
device will be possibly damaged or lead some harm if any other accessories are
used.

1. ECG
ECG Electrode
Type Patient category PN
Adult 15-100-0008
Disposable
Pediatric/ Neonatal 15-100-0009

ECG Cable
Type Description Standard PN
Snap 5-lead IEC 15-027-0003
Snap 3-lead IEC 15-027-0004
Snap 5-lead AHA 15-027-0001
Snap 3-lead AHA 15-027-0002

2. SpO2
Nellcor SpO2 Sensor

Type Model Patient category

MAX-A Adult finger (patient size>30kg)
MAX-P Pediatric foot/hand (patient size 10-50kg)
Disposable MAX-I Infant foot/hand (patient size 3-20kg)
Adult finger or neonatal foot/hand (patient size >40 kg or
MAX-N
<3 kg)
DS-100A Adult
Reusable OXI-A/N Adult / neonatal
OXI-P/I Pediatric / infant

Nellcor-SpO2 Extension cable

Accessories PN
Extension cable 15-100-0016

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BLT SpO2 Sensor

Type Patient category PN
Adult 15-100-0013
Reusable Pediatric 15-100-0014
Neonatal 15-100-0015

Masimo SpO2 Sensor

Type Model / PN Patient category

DCI / 2501 Adult finger
Reusable
DCIP / 2502 Pediatric finger
Disposable Neo / 2514 Infant foot/hand

Masimo SpO2 Extension cable

Accessories Model / PN
Extension cable M-LNC1 / 2523

3. Temp
Temp probe
Type Applied site PN
Surface 15-100-0027
Reusable
Coelom 15-100-0028

4. NIBP
Disposable cuffs
Model Patient category Limb circumference (cm) Bladder width (cm)
M1866A 3.1-5.7 2.5

M1868A 4.3-8.0 3.2

Neonatal
M1870A 5.8-10.9 4.3

M1872A 7.1-13.1 5.1

Disposable cuffs（SunTech）

Patient category Limb circumference (cm) PN

7-13 15-100-0173
Neonatal 6-11 15-100-0174
3-5.5 15-100-0175

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Reusable cuffs
Patient Limb circumference Bladder width
PN
category (cm) (cm)
Large adult 15-100-0021
Adult 25-35 14.4 15-100-0019
Small adult 20-28 11 15-100-0023
Pediatric 13-20 8 15-100-0022
Infant 10-18 5 15-100-0024
Neonatal 6-11 15-100-0025
Adult (Thigh) 15-100-0020

5. CO2
Mainstream CO2 (CAPNOSTAT5)
Accessories PN
CAPNOSTAT5 CO2 sensor 16-100-0015
Airway adapter (adult) 15-100-0042
Airway adapter(neonatal) 15-100-0043

Microstream CO2 (LoFlo)

Accessories PN
LoFlo CO2 sensor 16-100-0016
Airway adapter (adult) 15-100-0045
CO2 nasal cannula (adult) 15-100-0044
CO2 /O2 nasal cannule (adult) 15-100-0046
CO2 nasal cannule (pediatric) 15-100-0048
CO2 nasal cannule (infant) 15-100-0049

6. AG
Mainstream AG (IRMA)
Accessories PN
IRMA AX+ sensor 16-100-0019
Airway adapter (adult/pediatric) 15-100-0039
Airway adapter (infant) 15-100-0040
Extension cable 15-024-0001

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Sidestream AG (ISA)
Accessories PN
ISA OR+ module 16-100-0037
ISA module Modura holder 15-100-0090
ISA module Clamp Adapter 15-100-0091
Nomoline Sampling line 15-100-0089

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Appendix A Product Specifications

A.1 Environmental Specifications

Environment

Ambient Temperature Operating temperature: 0~+40℃

Transportation and storage temperature: –20~+55℃

Relative humidity Working ≤85%

Transportation and storage ≤93%

Atmospheric pressure Working 700~1060 hPa

Transportation and storage 500~1060 hPa

Power supply
Power Voltage AC 100-240V 50/60Hz
Power Input ≤70VA
Safety class Category I

A.2 Hardware Specifications

Size and weight

Size 210mm(H)×258mm(W)×180mm(D)
Weight ＜3.5kg (include recorder and battery)

Display
LCD
Size 8″
Type Color TFT-LCD
Resolution 800×600 pixels or higher
Indicators
Alarm LED 1 (Yellow/Red)
AC Power LED 1 (Green/Orange)
Battery Charge LED 1 (Yellow)

Battery

1
 Patient monitor user’s manual

Rechargeable Lithium ion battery

Type
11.1V/4.0AH
Charge time ≤6 hours
≥5 hours
Operating time under the New and fully charged battery at 25 ℃ ambient
normal use and full charge temperature and NIBP work on AUTO mode for 15
minutes interval.
Operating time after the first
≥10 minutes
alarm if low battery

Recorder (Option)
Method Thermal dot array
Paper width 50 mm
Record width 40 mm
Paper Speed 12.5 mm/s ,25 mm/s ,50 mm/s
Traces Maximum 3 tracks

Audio indicator
Speaker QRS Sound with Pitch Tone
Alarm Sound, according to the requirement of IEC
60601-1-8

Interface
Power supply 1 AC power socket
Wired network 1 standard RJ45 socket
Wireless network 1, 433MHz, 10mW (optional)
Nurse call 1 standard BNC socket, nurse call connector
Defibrillator synchronization 1 RJ11 socket
output
Video output 1 standard VGA display connector
Equipotentiality grounding 1
terminal

System output
Nurse Call signal
Driver mode Relay

2
 Patient monitor user’s manual

Specs ≤60W, ≤2A, ≤36VDC, ≤25VAC

Isolated voltage 1500VAC
Type N.C., N.O.
Defibrillator synchronization signal output
Output impedance 50Ω±10%
Delay ≤35 ms（from R wave crest to pulse raise）
Amplitude High level : 3.5 V to 5 V, the maximal output current
1mA.
Low level: < 0.5V, the maximal input current 5mA.
Pulse width 100ms ±10%
Rise and drop time < 1ms

Alarm
Level Low, medium and high
Indication Auditory and visual
Setup Default and custom
Silence All alarms can be silenced
Volume 45~85 dB measured at 1 meter

A.3 Measurement Specifications

ECG
1. 5-leads ECG input
Lead Mode
2. 3-leads ECG input
1. I, II, III, aVR, aVL, aVF, V-
Lead selection
2. I, II, III
Gain AUTO, 0.25x, 0.5x, 1.0x, 2.0x, 4.0x
Input impedance ≥5.0 MΩ
MON ≥105dB
CMRR
OPS ≥105dB
MON 0.5~40Hz
Frequency response OPS 1~25Hz
Electrode offset potential ±500mV d.c.
Leakage Current <10 uA
ECG signal range ±6.0 mV

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 Patient monitor user’s manual

Baseline recovery <5s after Defibrillation. (MON or OPS mode)

No rejection of pulses with amplitudes of ±2mV ~
Pacemaker pulses
±700 mV and durations of 0.5 ~ 2.0 ms.
Insulation Breakdown Voltage 4000VAC 50/60Hz
Indication of electrode
Every electrode (exclusive of RL)
separation
Sweep speed 12.5mm/s, 25mm/s, 50mm/s

HR
Measurement range 10~350 bpm
Refreshing time Per 4 pulses
Resolution 1 bpm
Accuracy ±1% or ±1 bpm, whichever is greater
Sensitivity ≥0.2mVpp
0~350 bpm, continuously adjustable between upper
Alarm range
limit and lower limit
Alarm indication Sound and light alarming
Time to Alarm for
Average 4s
Tachycardia
Tall T-Wave Rejection
0-1 mV T-Wave amplitude
Capability
HR change from 80 to 120 bpm:
Response Time of Heart Rate
Range: 6 to 10s
Meter to Change in Heart
HR change from 80 to 40 bpm:
Rate
Range: 6 to 10s
ST segment
Measurement range -2.0mV~2.0mV
-0.8mV~0.8mV ： ±0.02mV or ±10% whichever is
Accuracy greater
Over ±0.8mV: unspecified
Resolution 0.01mV
Refreshing time 10s
-2.00mV ～2.00mV, continuously adjustable between
Alarm range
upper limit and lower limit.
NIBP
Way of measurement Automatic oscillometry
Range of measurement Adult SYS 30~270 mmHg

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 Patient monitor user’s manual

DIA 10~220 mmHg

MEAN 20~235 mmHg
SYS 30~235 mmHg
Child DIA 10~220 mmHg
MEAN 20~225 mmHg
SYS 30~135 mmHg
Neonate DIA 10~110 mmHg
MEAN 20~125 mmHg
Range of HYPER
measurement (Only for adult)
SYS 40～300mmHg
DIA 10～250 mmHg
MEAN 20～270 mmHg
Cuff pressure range 0~280 mmHg (0～300mmHg at HYPER mode)
Resolution 1 mmHg
Pressure Accuracy
Static ±2% or ±3 mmHg, whichever is greater
Clinical ±5 mmHg average error
8 mmHg standard deviation
Unit mmHg, kPa
Pulse rate range 40 ~ 240 bpm
Inflation time for cuff Less than 40s. (standard adult cuff)
20 to 45s typical (dependent on heart rate and
Total cycle time motion artifact)
Intervals for AUTO 1,2,3,4,5,10,15,30,60,90 minutes
measurement time 2,4,8 hours
Adult : 170 mmHg
Pediatric : 130 mmHg
Initial inflation pressure
Neonatal : 100 mmHg
(The value can be adjusted manually）
Overpressure Protection Hardware and software double protections
Adult 297±3 mmHg
Child 252±3 mmHg
Neonatal 147±3 mmHg
0~300 mmHg, continuously adjustable
Alarm range SYS
between upper limit and lower limit

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 Patient monitor user’s manual

0~300 mmHg, continuously adjustable

DIA
between upper limit and lower limit
0~300 mmHg, continuously adjustable
MEAN
between upper limit and lower limit
Alarm indication Sound and light alarming
Adult Manual, Auto and STAT
Child Manual, Auto and STAT
Measurement Mode
Neonatal Manual, Auto
HYPER Manual, Auto and STAT

SunTech NIBP (option)

Way of measurement Oscillometry

SYS 40~260 mmHg
Adult DIA 20~200 mmHg
MEAN 26~220 mmHg
Range of measurement
SYS 40~160 mmHg
Child DIA 20~120 mmHg
MEAN 26~133 mmHg
SYS 40~130 mmHg
Range of measurement Neonate DIA 20~100 mmHg
MEAN 26~110mmHg
Pressure Accuracy
Static ±3 mmHg
Clinical ±5 mmHg average error
8 mmHg standard deviation
Unit mmHg, kPa
Pulse rate range 30 ~ 220 bpm
Pulse veracity 2bpm 或 3%, whichever is greater

Inflation time for cuff <75s

Adult: <180s
Measurement protection
Child: <180s
time
Neonate: <90s
Adult: 120~280mmHg，default 160mmHg
Initial inflation pressure Child: 80~170mmHg，default 120mmHg
Neonate: 60~140mmHg，default 90mmHg

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 Patient monitor user’s manual

Intervals for AUTO 1,2,3,4,5,10,15, 30, 60,90 minutes

measurement time 2,4,6 hours
Overpressure Protection Hardware and software double protections
Adult <300 mmHg
Child
<300 mmHg
Neonatal
<150 mmHg
Alarm indication Sound and light alarming
Adult Manual, Auto and STAT
Measurement Mode Child Manual, Auto and STAT
Neonatal Manual, Auto

SpO2
BLT-SpO2
Measurement Range 0~100%
Resolution 1%
At 70~100%, ±2%
Accuracy
At 0~69%, unspecified
Data update period <13s
0~100%, continuously adjustable between upper
Alarm range
limit and lower limit.
PR
Measurement Range 25~250 bpm
Resolution 1 bpm
Accuracy ±1% or ±1 bpm, whichever is greater
Data update period <13s
0~300 bpm, continuously adjustable between upper
Alarm range
limit and lower limit.

Nellcor-SpO2 ( option)
Measurement Range 0~100%
Resolution 1%
At 70~100%, ±2 digits (Adult)
At 70~100%, ±3 digits (Neonate)
Accuracy
At 70~100%, ±2 digits (Low Perfusion)
At 0~69%, unspecified
Perfusion Range 0.03 ~ 20%

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 Patient monitor user’s manual

Data update period Average 7s

0~100%, continuously adjustable between upper
Alarm range
limit and lower limit.
PR
Measurement Range 20~250 bpm
Resolution 1 bpm
Accuracy ±3 digits
Data update period Average 7s
0~300 bpm, continuously adjustable between upper
Alarm range
limit and lower limit.

Masimo-SpO2 ( option)
SpO2
Measurement Range 0~100%
Resolution 1%
At 70~100%：±2%（adult/pediatric, non-motion
conditions）
At 70 ~ 100%：±3%（neonate, non-motion
Accuracy
conditions）
At 70 ~100%：±3%（motion conditions）
At 0~69%，unspecified
Average time 2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s
0~100%, continuously adjustable between upper
Alarm range
limit and lower limit.
PR
Measurement Range 25~240 bpm
Resolution 1 bpm
±3 bpm（non-motion conditions）
Accuracy
±5 bpm（motion conditions）
0~300 bpm, continuously adjustable between upper
Alarm range
limit and lower limit.
PI
0.02 ~ 20.0% (for disposable sensor)
Measurement Range
0.05~ 20.0% (for reusable sensor)
Resolution 0.1%
PVI

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 Patient monitor user’s manual

Measurement Range 0 ~ 100%

Resolution 1%

TEMP
Measurement Range 0.0~50.0℃
Accuracy ±0.1℃
Resolution 0.1℃
Unit Celsius (℃), Fahrenheit (℉)
Refreshing time 1s
Self check Every 10 minutes
At 45.1~50.0℃, ±0.2℃ (exclusive of probe)
Accuracy At 25.0~45.0℃, ±0.1℃ (exclusive of probe)
At 0.0~24.9℃, ±0.2℃ (exclusive of probe)
Connecting cable Compatible with YSI-400
0.0~50.0 ℃, continuously adjustable between upper
Alarm range
limit and lower limit
Alarm indication Sound and light alarming

RESP
Method Impedance variation between RA-LL (R-F)
Measuring impedance range 0.2 ~3Ω
Excitation frequency 64.8 kHz
Excitation current ≤300μA at 64.8 kHz
Base line impedance range 500~4000Ω (50~120 kHz exciting frequency)
Measurement Range 0~150 rpm
Resolution 1 rpm
Accuracy ±2 rpm
Gain x1，x2，x4
Sweep speed 6.25mm/s, 12.5mm/s, 25mm/s
Delay of Apnea Alarm Off, 10s, 20s, 40s, 60s
0～150 rpm, continuously adjustable between upper
Alarm range
limit and lower limit.
Alarm indication Sound and light indication

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 Patient monitor user’s manual

CO2 (Microstream，LoFlo)
Measure method Infrared spectrum
Measure mode Microstream
Warm up time Capnogram displayed in less than 20 s, At an
ambient temperature of 25℃, full
specifications within 2 minutes.
CO2Measurement Range 0 ~ 19.7%(0 ~ 150 mmHg)
CO2 Resolution 1mmHg
CO2 Stability Short-Term Drift: Drift over four hours≤0.8mmHg.
Long-Term Drift: Accuracy specification will be
maintained over a 120 hours period.
unit %, mmHg, kPa
CO2 Accuracy 0 ~ 40 mmHg, ±2 mmHg
(at 760 mmHg, ambient 41 ~ 70 mmHg, ±5% of reading
temperature of 25°C) 71 ~100 mmHg, ±8% of reading
101 ~ 150 mmHg, ±10% of reading
Above 80 breath per minute ± 12% of reading
Gas temperature at 25℃.
CO2 response time ＜3s (includes transport time and rise time)
Respiration Rate Range 2~150 rpm
Respiration Rate Accuracy ±1 rpm
Sample Flow Rate 50 ml/min ±10 ml/min
0.0~13.1 % (0~99.6mmHg), continuously adjustable
Alarm range
between upper limit and lower limit
Alarm indication Sound and light indication

CO2 (Mainstream，CAPNOSTAT5)
Measure method Infrared spectrum
Measure mode Mainstream
Warm up time Capnogram displayed in less than 15 s, At an
ambient temperature of 25℃, full
specifications within 2 minutes.
CO2Measurement Range 0 ~ 19.7%(0 ~ 150 mmHg)
CO2 Resolution 1mmHg

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 Patient monitor user’s manual

CO2 Accuracy 0 ~ 40 mmHg, ±2 mmHg

41 ~ 70 mmHg, ±5% of reading
71 ~100 mmHg, ±8% of reading
101 ~ 150 mmHg, ±10% of reading
Temperature at 35℃.
CO2 Stability Short-Term Drift: Drift over four hours≤0.8 mmHg.
Long-Term Drift: Accuracy specification will be
maintained over a 120 hours period.
Rise time ＜60ms
unit %, mmHg, kPa
Respiration Rate Range 0~150 rpm
Respiration Rate Accuracy ±1 rpm
0.0~13.1 % (0~99.6mmHg), continuously adjustable
Alarm range
between upper limit and lower limit
Alarm indication Sound and light indication

AG (Mainstream, IRMA)
Measure method Infrared spectrum
Measure mode Mainstream
Fi and Et values CO2，N2O，O2，agent (HAL, ISO, ENF, SEV, DES)
Resolution 1%
Zeroing recommended when changing Airway
adapter. No span calibration required for the IR
Calibration bench.
Room air calibration of oxygen sensor performed
automatically when changing airway adapter (<5s)

Concentrations are reported and the automatic agent

Warm-up time identification is running within 10s. Full accuracy
within 20s for IRMA AX+.

CO2 ≤90ms
O2 ≤ 300 ms
Rise time (at 10 L/min)
N2O ≤ 300 ms
HAL, ISO, ENF, SEV, DES ≤ 300 ms
Total system response time <1s

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 Patient monitor user’s manual

0.15%. When an agent is identified, concentrations

Primary agent threshold will reported even below 0.15% as long as apnea is
not detected

Second agent threshold 0.2% + 10% of total agent concentration

Agent identification time < 20s. (Typically < 10s)
Measurement range and accuracy of gas:
Range (%)
Gas Accuracy1)
IRMA AX+

CO2 0-15 ±（0.3%ABS+4%REL）

N2O 0-100 ±（2% ABS+5% REL）
HAL, ISO, ENF 0-8 ±（0.2%ABS+10%REL）
SEV 0-10 ±（0.2%ABS+10%REL）
DES 0-22 ±（0.2%ABS+10%REL）
Respiration rate
0~150 rpm
range
Respiration rate
±1 rpm
accuracy
Alarm indication Sound and light indication
Note1: The accuracy specification is valid for the operating temperature and humidity conditions
specified, except for interference specified in the table “Interfering gas and vapor effects” below.
The accuracy specification for IRMA AX+ is not valid if more than two agents are present in the gas
mixture.

Interfering gas and vapor effects

If the concentration of the various gases is below the following level, there will be
negligible interference for measurement under the specification above.
 IRMA AX+ sensor:
Effect Effect
Gas or vapor Gas level Effect (CO2)
(Agents) (N2O)
N2O 60% — — —
HAL 4% — — —
ENF, ISO, SEV 5% — — —
DES 15% — — —
Xe (Xenon) 80% -10% of reading 1)
— —
He (Helium) 50% -6% of reading 1)
— —
Metered dose inhaler Not for use with metered dose inhaler propellants
Propellants
C2H5OH (Ethanol) 0.3% — — —
C3H7OH (Isopropanol) 0.5% — — —

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 Patient monitor user’s manual

CH3COCH3 (Acetone) 1% — — —
CH4 (Methane) 3% — — —
CO (Carbon monoxide) 1% — — —
NO (Nitrogen 0.02% — — —
monoxide)
O2 100% — — —

Note 1: Interference at indicated gas level. For example, 50 % Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 % CO2 and 50 % Helium,
the actual measured CO2 concentration will typically be (1-0.06) * 5.0 % = 4.7 % CO2.

AG (Sidestream, ISA)

Measurement mode Sidestream

Sampling flow rate 50ml/min ± 10ml/min
CO2，N2O，O2，agent (ISO，ENF，SEV，HAL，
Measurement parameters
DES)
Automatic compensation for pressure, temperature
Compensations
and broadening effects on CO2.
No span calibration is required for the IR bench. An
Calibration automatic zero reference calibration is performed at
startup and then every 24 hours.
< 20 s (Concentrations reported, automatic agent
Warm-up time
identification enabled and full accuracy)
CO2 ≤ 200 ms (≤ 250 ms for ISA OR+/AX+)
Typical rise time N2O ≤ 350 ms
at 50 ml/min sample flow O2 ≤ 450 ms
ISO, ENF, SEV,HAL,DES ≤ 350 ms
Total system response time < 3 s (with 2 m sampling line)
0.15%. When an agent is identified, concentrations
Primary agent threshold
will be reported even below 0.15%.
Secondary agent threshold 0.2 % + 10% of total agent concentration
Agent identification time < 20 s (typically < 10 s)
Measurement range and accuracy of gas:
Gas Range Accuracy1)
CO2 0-15% ±（0.3 kPa + 4% of reading）
N2O 0-100% ±（2 kPa + 5% of reading）
HAL, ENF, ISO 0-8% ±（0.2 kPa + 10% of reading）
SEV 0-10% ±（0.2 kPa + 10% of reading）

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 Patient monitor user’s manual

DES 0-22% ±（0.2 kPa + 10% of reading）

O2 0-100% ±（2 kPa + 2% of reading）
Note 1: The accuracy specification is valid for the operating temperature and humidity conditions
specified, except for interference specified in the table “Interfering gas and vapor effects” below.
The accuracy specification is not valid if more than two agents are present in the gas mixture. If more
than two agents are present, an alarm will be set.

Interfering gas and vapor effects

If the concentration of the various gases is below the following level, there will be
negligible interference for measurement under the specification above.

 ISA AX+ sensor:

Effect Effect
Gas or vapor Gas level Effect (CO2)
(Agents) (N2O)
N2O 60% — — —
HAL 4% — — —
ENF, ISO, SEV 5% — — —
DES 15% — — —
Xe (Xenon) 80% -10% of reading 1)
— —
He (Helium) 50% -6% of reading 1)
— —
Metered dose inhaler Not for use with metered dose inhaler propellants
Propellants
C2H5OH (Ethanol) 0.3% — — —
C3H7OH (Isopropanol) 0.5% — — —
CH3COCH3 (Acetone) 1% — — —
CH4 (Methane) 3% — — —
CO (Carbon monoxide) 1% — — —
NO (Nitrogen 0.02% — — —
monoxide)
O2 100% — — —

Note 1: Interference at indicated gas level. For example, 50 % Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 % CO2 and 50 % Helium,
the actual measured CO2 concentration will typically be (1-0.06) * 5.0 % = 4.7 % CO2.

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 Patient monitor user’s manual

Appendix B Default System Setup

There are three options of default system setup: ADULT, CHILD, NEONATAL. The
followings are the details:

B.1 System

1. Standard Configuration
1） Trend Graph Configuration
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 PR
Region 4 NIBP
Region 5 Resp
Region 6 T1+T2

2）Trend Table Configuration

Page 1
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 PR
Region 4 NIBP(S/D)
Region 5 NIBP(M)
Region 6 Resp

Page 2
Region Parameter
Region 1 HR
Region 2 T1
Region 3 T2

2. Standard Configuration + EtCO2

1）Trend Graph Configuration
Page 1
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 PR
Region 4 NIBP
Region 5 RESP
Region 6 T1+T2

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 Patient monitor user’s manual

Page 2
Region Parameter
Region 1 CO2

2）Trend Table Configuration

Page 1
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 PR
Region 4 NIBP(S/D)
Region 5 NIBP(M)
Region 6 Resp

Page 2
Region Parameter
Region 1 T1
Region 2 T2
Region 3 CO2

3. Standard Configuration + EtCO2+GAS

1）Trend Graph Configuration
Page 1
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 CO2
Region 4 PR
Region 5 NIBP
Region 6 Resp

Page 2
Region Parameter
Region 1 O2+N2O
Region 2 AA
Region 3 T1+T2

2）Trend Table Configuration

Page 1
Region Parameter
Region 1 HR
Region 2 SpO2
Region 3 CO2
Region 4 PR
Region 5 NIBP(S/D)
Region 6 NIBP(M)

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 Patient monitor user’s manual

Page 2
Region Parameter
Region 1 Resp
Region 2 T1
Region 3 T2
Region 4 CO2
Region 5 N2O
Region 6 AA

Page 3
Region Parameter
Region 1 O2

B.2 Alarm Limit

1. Setup of parameters alarm limit for adult

Parameter Low limit High limit
HR (bpm) 50 120
SpO2 (%) 90 100
PR (bpm) 50 120
RR (rpm) 8 30
T1 (℃) 36.0 39.0
T2 (℃) 36.0 39.0
NIBP SYS(mmHg) 90 160
NIBP DIA (mmHg) 50 90
NIBP MEAN (mmHg) 60 110
EtCO2 (mmHg) 20 50
FiCO2 (mmHg) 0 20
EtAA (%) 0.0 3.0
FiAA (%) 0.0 5.0
EtN20 (%) 0 82
FiN20 (%) 0 82
EtO2 (%) 10 100
FiO2 (%) 18 100

2. Setup of parameters alarm limit for child

Parameter Low limit High limit
HR (bpm) 75 160
SpO2 (%) 90 100

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 Patient monitor user’s manual

PR (bpm) 75 160
RR (rpm) 8 30
T1 (℃) 36.0 39.0
T2 (℃) 36.0 39.0
NIBP SYS (mmHg) 70 120
NIBP DIA (mmHg) 40 70
NIBP MEAN (mmHg) 50 90
EtCO2 (mmHg) 20 50
FiCO2 (mmHg) 0 20
EtAA (%) 0.0 3.0
FiAA (%) 0.0 5.0
EtN20 (%) 0 82
FiN20 (%) 0 82
EtO2 (%) 10 100
FiO2 (%) 18 100

3. Setup of parameters alarm limit for neonate

Parameter Low limit High limit
HR (bpm) 90 200
SpO2 (%) 85 95
PR (bpm) 90 200
RR (rpm) 30 100
T1 (℃) 36.0 39.0
T2 (℃) 36.0 39.0
NIBP SYS(mmHg) 40 90
NIBP DIA (mmHg) 20 60
NIBP MEAN (mmHg) 25 70
EtCO2 (mmHg) 20 45
FiCO2 (mmHg) 0 20
EtAA (%) 0.0 3.0
FiAA (%) 0.0 5.0
EtN20 (%) 0 82
FiN20 (%) 0 82
EtO2 (%) 10 100
FiO2 (%) 18 100

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 Patient monitor user’s manual

Appendix C EMC

Guidance and manufacture’s declaration – electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic emission

The Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the
Multi-parameter Monitor should assure that it is used in such and environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions Group 1 The Monitor uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.

RF emission The Monitor is suitable for use in all establishments other

Class A
CISPR 11 than domestic and those directly connected to the public
Harmonic emissions low-voltage power supply network that supplies buildings
Class A
IEC 61000-3-2 used for domestic purposes.
Voltage fluctuations/ flicker
emissions Complies
IEC 61000-3-3

Guidance and manufacture’s declaration – electromagnetic immunity –

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity

The Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Low
Frequency Therapeutic Device should assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level
guidance
Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood, concrete or
(ESD) 8 kV air 8 kV air ceramic tile. If floor are covered with
IEC 61000-4-2 synthetic material, the relative
humidity should be at least 30%.
Electrical fast 2 kV for power supply 2 k V for power supply Mains power quality should be that of
transient/burst lines lines a typical commercial or hospital
IEC 61000-4-4 1 kV for input/output lines 1 kV for input/output environment.
lines
Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of
IEC 61000-4-5 2 kV common mode 2 kV common mode a typical commercial or hospital
environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that of
interruptions and (>95% dip in UT) (>95% dip in UT) a typical commercial or hospital
voltage variations on for 0.5 cycle for 0.5 cycle environment.
power supply input 40% UT 40% UT
lines (60% dip in UT) (60% dip in UT)
IEC 61000-4-11 for 5 cycles for 5 cycles
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency magnetic fields
(50Hz) magnetic field should be at levels characteristic of a
IEC 61000-4-8 typical location in a typical commercial
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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 Patient monitor user’s manual

Guidance and manufacture’s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration – electromagnetic immunity

The Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Low
Frequency Therapeutic Device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the patient
monitor, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
 3 .5 
Conducted RF 3 Vrms 3 Vrms d   P
IEC 61000-4-6 150 kHz to 80 MHz
 V1 

 3 .5 
d   P
 E1  80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz 7
d   P
 E1  800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Low Frequency Therapeutic Device is used
exceeds the applicable RF compliance level above, the Low Frequency Therapeutic Device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Low Frequency Therapeutic Device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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 Patient monitor user’s manual

Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the Low Frequency Therapeutic Device
The Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Low Frequency Therapeutic Device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Low Frequency Therapeutic Device as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter  3 .5   3 .5  7
(W) d   P d   P d   P
 V1   E1   E1 
0.01 0.35 0.12 0.23
0.1 1.1 0.38 0.73
1 3.5 1.2 2.3
10 11 3.8 7.3
100 35 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

21
 Product name: Patient Monitor

Product type: M8500

Manufacture for BIOLIGHT MEDITECH USA

Address: 533 Broadhollow Road Ste B-24, Melville, New York 11747

Fax: 888-785-8948

Toll-free consultation hot line: 888-82-BLTUSA (888-822-5887)

Post code: 519085

PN: 22-039-0001