PAVO

CETUS x12, CETUS x15, CETUS xL

-Multi-Parameter Patient Monitor-

INSTRUCTIONS FOR USE

Revision: 2.0
Document ID: PM 201234-22.1
Document language: English
 Document ID: PM 201234-022.1 – Revision: 2.0 EN

Notice
Thanks for purchasing aXcent medical Multi-parameter Patient Monitor.

Before operating, please read this Manual carefully to ensure proper use.

Please keep this Manual properly for future reference.

Product Name: Multi-Parameter Patient Monitor

Model: PAVO, CETUS x12, CETUS x15, CETUS xL

Structure and The monitor consists of master unit, display, ECG cable, SpO2
probe, blood pressure cuff, temperature probe and CO2
Components: components.
Intended Use: The Multi-Parameter Patient Monitor is intended for
monitoring,display,review ,storing ,alarm of multiple
physiological parameters of human body, including ECG (3-
lead,5-lead,or 12-lead optional, detection Heart Rate）
respiration (RESP), pulse rate (PR), blood oxygen saturation
(SPO2), noninvasive blood pressure (NIBP), temperature
(TEMP) , carbon dioxide (CO2).

The multi-parameter patient monitor intended for use on adult,

pediatric and neonatal patients and on one patient at a time.

Manufacturer: aXcent medical GmbH

Registered Address: Josef-Görres-Platz 2

56068 Koblenz / Germany

Manufacturing Dr.-Walter-Lessing-Str. 4

56112 Lahnstein / Germany

Address:

Version: 2.0

Release: November 2022

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Intellectual Property Rights

The intellectual property rights of this Operator’s Manual and the corresponding product
belong to aXcent medical GmbH (hereinafter referred to as “aXcent”).

This Manual contains proprietary information protected by copyright law. Without written
permission of aXcent, any organization or individual is prohibited to photograph, copy, modify
or print any part of this Manual, or translate into other languages.

However, aXcent is not liable for any incidental or consequential damages to the actual
performance and use due to errors in this Manual or the provision of this Manual. aXcent does
not provide license conferred by patent law to any other parties. aXcent does not assume legal
responsibility for the legal consequences resulting from violating the patent law and the rights
of any third party.

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Statement
aXcent reserves the right of final interpretation to this Manual.

The content of this Manual is subject to change without prior notice.

Only if the following requirements are met, aXcent will be responsible for the safety,
reliability and performance of the product, i.e.:

◼ Assembly, expansion, re-adjustment, improvement and repair should only be performed

by qualified personnel approved by aXcent;

◼ All the replaced parts and supported accessories and consumables relate to the
maintenance shall be originally from aXcent or others approved by aXcent;

◼ The electrical equipment complies with relevant standards and the requirements of this
Manual;

◼ The product is operated in accordance with this Manual.

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Warranty and Maintenance Services

The warranty period is 2 years for this product and 6 month for the main accessories. The
main accessories include: blood oxygen probe and extension cable, ECG cable, blood
pressure cuff and catheter, temperature probe, power cord, stent, and ground wire.
Consumables are disposable materials that should be replaced after each use or wearing parts
that should be replaced periodically. The consumables are not covered by warranty.

The warranty period is counted from the “Installation Date” filled in the Warranty Card,
which is the only certificate to check the period of warranty. To protect your rights, please
urge your installation personnel to send the second copy of the Warranty Card to aXcent
within 30 days from the date of installation; if the Warranty Card for the product purchased is
not sent to aXcent on time, the warranty period will be calculated after 45 days from the
“Delivery Date” marked on the packing box.

aXcent will be responsible for the safety, reliability and performance of the product if the
following requirements are met:

◼ The product is used in accordance with the Operator’s Manual.

◼ Product installation, repair and upgrade are carried out by personnel approved or

authorized by aXcent.

◼ The storage, operating and electrical environment meets product specifications.

◼ The S/N label or manufacturer logo of the product is clearly visible, and it is identified

and confirmed that the product is manufactured by aXcent.

◼ The damage is caused by non-human factors (human factors include accidentally

dropping, sabotage, etc.).

The products that meet the warranty regulations can enjoy free service, and the products
beyond the scope of the warranty will be charged for service. The freight (including customs
fees) for transport of this product to aXcent for maintenance is assumed by the user. For the
maintenance due to any reason other than the abovementioned causes, aXcent will charge for
service, and the user needs to pay additional costs for maintenance and parts.

When the warranty expires, aXcent will continue to provide charged maintenance services.

If you do not pay or delay the payment of maintenance fees, aXcent will suspend the repair
services until you pay up.

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After-sales Service Unit

Manufacturer:

aXcent medical GmbH

Josef-Görres-Platz 2

56068 Koblenz

Germany

Tel: +49 261 3011 117

Fax: +49 261 3011 111

Website: www.axcentmedical.com

Mail: info@axcentmedical.com

NOTE: Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.

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Preface
Notice
This Operator’s Manual is the necessary instructions for the safe use of this product. This
Manual introduces the use, properties, method of operation, safety information and intended
use of the Multi-parameter Patient Monitor in details. Before using the product, please carefully
read and understand the contents of this Manual, and abide by the method of operation stated
in this Manual in order to ensure the safety of patients and operators.

This Operator’s Manual is a major component of the product, and should always be placed
near the product for easy reference.

Object of Application

This Operator’s Manual is intended for professional clinical staff or personnel with experience
in the use of monitoring equipment. The readers should have knowledge and work experience
in medical procedures, practices and terminology of patient monitoring.

Illustration

All the illustrations in this Operator’s Manual are for reference only. The menus, settings and
parameters of the illustrations may be different from the monitor.

Convention

◼ [Character]: Used to represent the string in the software or characters on the interface.

◼ →: This symbol is used to indicate operation step.

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Content
Chapter 1. Safety ..................................................................................................................................................... 15

1.1 Safety Information ........................................................................................................................ 15

1.1.1 Danger ................................................................................................................................. 15
1.1.2 Warning ............................................................................................................................... 15
1.1.3 Caution ................................................................................................................................ 16
1.1.4 Note .................................................................................................................................... 17
1.2 Symbols ........................................................................................................................................ 17
Chapter 2. Monitor Overview .................................................................................................................................. 19

2.1 Introduction ................................................................................................................................. 19

2.1.1 Intended Use ....................................................................................................................... 19
2.1.2 Contraindications ................................................................................................................ 19
2.1.3 Composition and Structure ................................................................................................. 19
2.1.4 Expected Clinical benefit ..................................................................................................... 19
2.2 Master Unit .................................................................................................................................. 20
2.2.1 Front View ........................................................................................................................... 20
2.2.2 Side View ............................................................................................................................. 25
2.2.3 Rear View ............................................................................................................................ 27
2.3 Screen Display .............................................................................................................................. 30
2.4 Smart Hotkeys .............................................................................................................................. 32
2.5 Product Configuration and differences......................................................................................... 33
2.6 Residual Risks ............................................................................................................................... 33
Chapter 3. Basic Operation ...................................................................................................................................... 34

3.1 Installation .................................................................................................................................... 34

3.1.1 Unpacking ........................................................................................................................... 34
3.1.2 Environmental Requirements .............................................................................................. 35
3.2 Connecting to AC Power ............................................................................................................... 36
3.3 Turning on .................................................................................................................................... 36
3.3.1 Checking the Monitor ......................................................................................................... 36
3.3.2 Starting the Monitor ........................................................................................................... 36
3.3.3 Connecting the Sensor ........................................................................................................ 37
3.3.4 Starting Monitoring ............................................................................................................. 37
3.4 Turning off .................................................................................................................................... 37
3.5 Basic Operation ............................................................................................................................ 38
3.5.1 Using the Shuttle ................................................................................................................. 38
3.5.2 Using Keys ........................................................................................................................... 38
3.5.3 Using the Touch Screen ....................................................................................................... 38
3.5.4 Using Soft Keyboard ............................................................................................................ 39
3.5.5 Using Menu ......................................................................................................................... 39
3.6 Operating Mode ........................................................................................................................... 40
3.7 Measurement Setup ..................................................................................................................... 40
3.8 Freezing Waves ............................................................................................................................. 41
3.9 Other Common Setup .................................................................................................................. 41

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3.9.1 Defining the Monitor........................................................................................................... 41

3.9.2 Language Setup ................................................................................................................... 41
3.9.3 Date and Time ..................................................................................................................... 42
3.9.4 Volume Control ................................................................................................................... 42
3.9.5 Setting Parameter Unit ........................................................................................................ 43
Chapter 4. Patient Information Management ......................................................................................................... 44

4.1 Patient Setup Menu...................................................................................................................... 44

4.2 Admitting a Patient Quickly .......................................................................................................... 45
4.3 Admitting a Patient....................................................................................................................... 46
4.4 Editing Patient Info ....................................................................................................................... 47
4.5 Discharging a Patient .................................................................................................................... 48
Chapter 5. User Interface ......................................................................................................................................... 49

5.1 Selecting User Interface ............................................................................................................... 49

5.2 Interface Introduction .................................................................................................................. 50
5.2.1 Normal Screen..................................................................................................................... 50
5.2.2 Big Numerics ....................................................................................................................... 51
5.2.3 ECG 7-Lead Half-Screen ....................................................................................................... 51
5.2.4 ECG 7-Lead Full-Screen ....................................................................................................... 52
5.2.5 ECG 12-Lead Full-Screen ..................................................................................................... 52
5.2.6 OxyCRG Screen .................................................................................................................... 53
5.2.7 DynaTrend Screen ............................................................................................................... 54
Chapter 6. Alarm ...................................................................................................................................................... 55

6.1 Alarm Type ................................................................................................................................... 55

6.2 Alarm Level ................................................................................................................................... 56
6.3 Alarm Mode ................................................................................................................................. 56
6.3.1 Light Alarm .......................................................................................................................... 57
6.3.2 Audible Alarm ..................................................................................................................... 57
6.3.3 Alarm Info ........................................................................................................................... 57
6.3.4 Parameter Flashing.............................................................................................................. 58
6.4 Alarm States ................................................................................................................................. 58
6.4.1 Silence ................................................................................................................................. 58
6.4.2 Alarm sound off................................................................................................................... 58
6.4.3 Alarm Pause ........................................................................................................................ 59
6.4.4 Alarm off ............................................................................................................................. 59
6.5 Alarm Setup .................................................................................................................................. 60
6.5.1 Setting the Alarm Sound ..................................................................................................... 60
6.5.2 Setting the Alarm Delay Time .............................................................................................. 60
6.5.3 Setting a Parameter Alarm .................................................................................................. 61
6.6 Latch Alarm .................................................................................................................................. 62
6.7 Manual Event ............................................................................................................................... 63
Chapter 7. ECG ......................................................................................................................................................... 64

7.1 Overview ...................................................................................................................................... 64

7.2 Safety Information ........................................................................................................................ 64
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7.3 Monitoring Steps .......................................................................................................................... 65

7.3.1 Preparation ......................................................................................................................... 65
7.3.2 Selecting Lead ..................................................................................................................... 66
7.3.3 Lead Name and Corresponding Color ................................................................................. 66
7.3.4 Installing Electrodes ............................................................................................................ 67
7.3.5 Checking the Pacemaking Status ......................................................................................... 70
7.4 ECG Display ................................................................................................................................... 70
7.5 Alarm Setup .................................................................................................................................. 71
7.6 ECG Setup ..................................................................................................................................... 72
Chapter 8. Resp ........................................................................................................................................................ 74

8.1 Overview ...................................................................................................................................... 74

8.2 Safety Information ........................................................................................................................ 74
8.3 Placing Electrodes for Respiration Monitoring ............................................................................. 74
8.3.1 Adjusting Position of Respiration Electrode ........................................................................ 75
8.3.2 Cardiomotility Superimposing ............................................................................................. 75
8.4 Resp Display ................................................................................................................................. 76
8.5 Resp Setup .................................................................................................................................... 76
8.5.1 Setting Apnea Time ............................................................................................................. 77
8.5.2 Adjusting Wave Gain ........................................................................................................... 77
8.5.3 Setting Scanning Speed ....................................................................................................... 77
8.6 Alarm Setup .................................................................................................................................. 77
Chapter 9. PR ........................................................................................................................................................... 78

9.1 Overview ...................................................................................................................................... 78

9.2 Display .......................................................................................................................................... 78
9.3 Setting PR Sound .......................................................................................................................... 78
9.4 Alarm Setup .................................................................................................................................. 78
Chapter 10. SpO2 ..................................................................................................................................................... 80

10.1 Overview ...................................................................................................................................... 80

10.2 Safety Information ........................................................................................................................ 80
10.3 Monitoring Steps .......................................................................................................................... 81
10.4 Display .......................................................................................................................................... 82
10.5 Setting SpO2 ................................................................................................................................. 83
10.5.1 Setting Wave Speed ............................................................................................................ 84
10.5.2 Setting Wave Mode ............................................................................................................. 84
10.5.3 Setting Average Time .......................................................................................................... 84
10.6 Measuring Influencing Factors ..................................................................................................... 84
10.7 Alarm Setup .................................................................................................................................. 85
10.8 Masimo Information..................................................................................................................... 86
Chapter 11. NIBP ...................................................................................................................................................... 91

11.1 Overview ...................................................................................................................................... 91

11.2 Safety Information ........................................................................................................................ 92
11.3 Measurement Limits .................................................................................................................... 92
11.4 Measurement Procedure ............................................................................................................. 94
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11.4.1 Preparing for Measurement ................................................................................................ 94

11.4.2 Patient posture requirements during measurement........................................................... 94
11.4.3 Starting / Stopping Measurement ....................................................................................... 94
11.4.4 Correcting Measurement Results ........................................................................................ 94
11.5 NIBP Display ................................................................................................................................. 95
11.6 Setting Inflation Pressure ............................................................................................................. 95
11.7 NIBP Resetting .............................................................................................................................. 95
11.8 NIBP Leakage Test ......................................................................................................................... 96
11.9 NIBP Calibration ........................................................................................................................... 97
11.10 Clean and disinfection method of NIBP cuff ................................................................................. 97
11.10.1 Cleaning Method: ...................................................................................................... 97
11.10.2 Disinfection Method .................................................................................................. 97
11.11 Alarm Setup .................................................................................................................................. 97
Chapter 12. Temp .................................................................................................................................................... 98

12.1 Overview ...................................................................................................................................... 98

12.2 Safety Information ........................................................................................................................ 98
12.3 Measurement Steps ..................................................................................................................... 98
12.4 Measuring Requirements ............................................................................................................. 98
12.5 Temp Display ................................................................................................................................ 99
12.6 Selecting Resistance Type of Temp Probe..................................................................................... 99
12.7 Setting Temperature Unit ........................................................................................................... 100
12.8 Alarm Setup ................................................................................................................................ 100
12.9 Quick Temp(Optional) ................................................................................................................ 100
12.9.1 Quick Temperature Display ....................................................................................................... 100
12.9.2. Accessories list .................................................................................................................. 101
Chapter 13. Review ................................................................................................................................................ 103

13.1 Reviewing Trend Chart ............................................................................................................... 103

13.2 Reviewing Trend Table ................................................................................................................ 104
13.3 NIBP Measurement Review ........................................................................................................ 105
13.4 Event Review .............................................................................................................................. 106
Chapter 14. CO2 ..................................................................................................................................................... 108

14.1 Introduction .......................................................................................................................................... 108

14.2 Preparing to Measure CO2 .................................................................................................................... 109
14.2.1 Using a Sidestream CO2 Module .............................................................................................. 109
14.2.2 Using a Mainstream CO2 Module ............................................................................................. 110
14.3 CO2 Settings .......................................................................................................................................... 112
14.4 Measurement limitations...................................................................................................................... 113
14.5 Zeroing the Sensor ................................................................................................................................ 113
14.6 Notice ................................................................................................................................................... 114
14.7 Cleaning ................................................................................................................................................ 114
Chapter 15. Recording (Optional) .......................................................................................................................... 115

15.1 Recorder Profile .................................................................................................................................... 115

15.2 Loading Paper ....................................................................................................................................... 116
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15.3 Setting up the Recorder ........................................................................................................................ 116

15.4 Clearing Recorder ................................................................................................................................. 117
Chapter 16. Battery ................................................................................................................................................ 118

16.1 Checking Battery Performance ............................................................................................................. 118

16.2 Overview ............................................................................................................................................... 118
16.3 Installing the battery ............................................................................................................................. 119
16.4 Battery Usage Guide ............................................................................................................................. 119
16.5 Battery Recycling................................................................................................................................... 120
Chapter 17. Cleaning and Disinfection ................................................................................................................... 121

17.1 Cleaning and disinfection safety information ....................................................................................... 121

17.2 Approved detergents and disinfectants ................................................................................................ 122
17.3Methods for Cleaning and Disinfection ................................................................................................. 122
17.4 Environmental protection, safe disposal ............................................................................................... 124
Chapter 18. Maintenance ...................................................................................................................................... 126

18.1 Checking................................................................................................................................................ 126

18.2 Viewing Software Version Info .............................................................................................................. 127
18.3 Maintenance Plan ................................................................................................................................. 127
18.4 ECG Calibration ..................................................................................................................................... 128
18.5 Touch Screen Calibration ...................................................................................................................... 128
18.6 CO2 Calibration ..................................................................................................................................... 129
Chapter 19. Accessories ......................................................................................................................................... 130

19.1 Accessories List ..................................................................................................................................... 130

Chapter 20. Maintenance ...................................................................................................................................... 134

20.1 Maintenance Introduction .................................................................................................................... 134

20.2 Maintenance Safety Information .......................................................................................................... 134
20.3 Maintenance and Testing Schedule ...................................................................................................... 135
20.4 Testing Methods and Procedures .......................................................................................................... 136
Chapter 21. Cybersecurity...................................................................................................................................... 137

21.1 Testing Methods and Procedures .......................................................................................................... 137

Appendix A Specifications ...................................................................................................................................... 139

A.1 Safety Specifications ............................................................................................................................... 139

A.1.1 Product Category ........................................................................................................................ 139
A.1.2 Power Specifications .................................................................................................................. 139
A.2 Hardware Specifications ......................................................................................................................... 140
A.2.1 Physical Specifications ................................................................................................................ 140
A.2.2 Display ........................................................................................................................................ 140
A.2.3 Host LED ..................................................................................................................................... 141
A.2.4 Audio Instruction ........................................................................................................................ 141
A.2.5 Alarm Signal ............................................................................................................................... 141
A.3 Data Storage ........................................................................................................................................... 141
A.4 Measurement Specifications .................................................................................................................. 142

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A.4.1 ECG/TEMP/RESP Specifications .................................................................................................. 142

A.4.2 NIBP Specifications ..................................................................................................................... 144
A.4.3 SpO2 Specifications .................................................................................................................... 145
A.4.4 CO2 Specification ............................................................................................................... 146
Appendix B EMC..................................................................................................................................................... 149

Appendix C Alarm Information .............................................................................................................................. 153

C.1 Physiological Alarm Information ............................................................................................................. 153

C.2 Technical Alarm Information ................................................................................................................... 156
Appendix D Default Parameter Configuration ....................................................................................................... 160

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Chapter 1. Safety
1.1 Safety Information

Danger
⚫ A warning that alerts you to a potential serious outcome, adverse event or safety hazard.
Failure to observe a warning may result in serious injury or death to the user or patient.

Warning
⚫ Alerts you to potential hazard or unsafe operation. Failure to avoid such hazard or operation
may result in minor or moderate personal injury or damage to the product or other properties,
and possibly in a remote risk of more serious injury.

Caution
⚫ In order to safely use the device continuously, it is required to comply with the instructions
listed. The instructions listed in this Manual are not substitute for the medical procedure
being performed.

Note

⚫ Emphasize important considerations, and provide a description or explanation in order to

make better use of the product.

⚫ In order to safely use the device continuously, it is required to comply with the instructions
listed. The instructions listed in this Manual are not substitute for the medical procedure
being performed.

1.1.1 Danger

This product does not involve information of danger levels.

1.1.2 Warning

Warning
⚫ This monitor is used for clinical patient monitoring, and only trained and qualified doctors
and nurses are allowed to use this monitor.

⚫ Before operating, the user must check if the device, cables and accessories are functioning
properly and safely.
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⚫ The alarm volume, upper and lower alarm limit should be set according to the actual situation
of the patient. Do not just rely on audio alarm system while monitoring the patient, because
too low alarm volume or complete shutdown may result in alarm failure and endanger the
patient safety. Please pay close attention to the actual clinical situation of the patient.

⚫ This device can only be connected to a grounded electrical outlet; if the power outlet is not
connected to the ground wire, do not use the outlet; instead, supply power to the device with
rechargeable batteries.

⚫ Do not open the enclosure in order to avoid an electric shock. Any repair and upgrade of the
monitor must be done by service personnel trained and authorized by aXcent.

⚫ When handling packaging materials, abide by local laws and regulations or hospital waste
disposal regulations. Keep the packaging materials away from children.

⚫ Do not use this instrument at a place with in flammables such as anesthetics to prevent
explosion or fire.

⚫ Please install the power lines and cables of accessories carefully to avoid patient
entanglement or suffocation, cables tangled or electrical interference.

⚫ The devices connected to the monitor should form an equipotential body (protective
grounding effectively connected).

⚫ When the monitor is used together with electrosurgical devices, the user (a doctor or a nurse)
should ensure the safety of the patient and instrument.

⚫ The physiological wave, physiological parameters and alarm information displayed on the
monitor are only for the doctor’s reference and should not be directly used as the basis for
clinical treatment.

⚫ This is not a therapeutic unit.

⚫ For patients with pacemakers, the cardiotach ometer may count the pacemaker pulse in case
of a cardiac arrest or arrhythmias. Never rely solely on the cardiotach ometer alarm. Closely
monitor the patients with pacemakers. For the inhibition of the device on pacemakers, refer to
this Operator’s Manual.

1.1.3 Caution

Caution
⚫ To avoid damage to the instrument and to ensure patient safety, please use the accessories
specified in this Manual.

⚫ Please install or carry the instrument properly to prevent damage due to falling, collision,
strong vibration or other mechanical force.

⚫ The electromagnetic fields may affect the performance of the instrument, so that using other
devices in the vicinity of this instrument must comply with relevant EMC requirements. For

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example: mobile phone, X-ray or MRI equipment is likely to be a source of interference,

since they will transmit high intensity electromagnetic radiation.
⚫ Before powering on the device, make sure that the power used by the device complies with
the supply voltage and frequency requirements on the equipment label or in the Operator’s
Manual.

⚫ When the instrument and accessories are about to exceed the useful life, it must be treated in
accordance with relevant local laws and regulations or the hospital's rules and regulations.

1.1.4 Note

Notes

⚫ Install the device at a place easy for observation, operation and maintenance.

⚫ Keep this Manual near the instrument for easy reference.

⚫ The instrument should be used only by one patient at the same time.

1.2 Symbols
The symbols appearing on the instrument are as follows:

Defibrillation-proof type CF applied part Auxiliary output interface

Defibrillation-proof type BF applied part USB interface

Caution: Refer to accompanying documents

Network Interface
(Operator’s Manual).

Signal input and output

Power on / off
interface

AC power supply (AC) Display Interface

Battery operating indicator Equipotential terminal

Alarm silence Serial Number

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NIBP Production date

Wave freezing Manufacturer info

Waste Electrical and

Print Electronic Equipment
Directive

Medical device
Refer to the Operator’s Manual

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Chapter 2. Monitor Overview

2.1 Introduction

2.1.1 Intended Use

The multi-Parameter Patient Monitor is intended for monitoring, display, review, storing, alarm of
multiple physiological parameters of human body, including ECG (3-lead,5-lead, or 12-lead
optional, detection Heart Rate), respiration (RESP), pulse rate (PR), blood oxygen saturation
(SPO2), noninvasive blood pressure (NIBP), temperature (TEMP) , carbon dioxide (CO2).

The multi-parameter patient monitor intended for use on adult, pediatric patients and on one
patient at a time.

2.1.2 Contraindications
The multi-parameter patient monitor does not have any contraindications.

The accessories are contraindicated for patients who exhibit allergic reactions to foam rubber
products and/or adhesive tape.

2.1.3 Composition and Structure

The monitor consists of master unit, Display, ECG cable, SpO2 probe, Blood oxygen cuff,
temperature probe, CO2 components, and built-in lithium battery.

2.1.4 Expected Clinical benefit

The multi parameter monitor is mainly a medical instrument used to monitor various vital signs of
patients, especially for monitoring the heart rate, blood pressure, respiration, oxygen saturation,
etc. of critically ill patients or patients undergoing surgery. Through the monitoring of these vital
signs, we can understand the patient's heart rate change, blood pressure change, respiratory
frequency, blood oxygen saturation and other indicators, provide the basis for the patient's disease
diagnosis and treatment, and timely adjust the drug dose according to the specific monitoring data,
as well as adjust the use of medical treatment instruments such as ventilator parameters.
In addition, the multi parameter monitor also has the function of alarm and reminder, as well as
the functions of data storage and transmission, which can enable medical staff to timely
understand the changes of patients' vital signs, and provide data support for the analysis of
patients' entire diagnosis and treatment process, especially in the diagnosis and treatment of
patients with severe diseases.

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2.2 Master Unit

2.2.1 Front View

Fig. 2-1 Front View (CETUS x15)

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Fig. 2-2 Front View (CETUS xL)

Fig. 2-3 Front View (CETUS x12)

1. Company logo
2. Alarm indicator

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The alarm indicator indicates the levels of physiological alarms and technical alarms in
different colors and flashing frequencies:
◼ High: red, fast flashes
◼ Medium: yellow, slow flashes
◼ Low: yellow, lit without flashing.
3. Display
4. Power on / off button
◼ Power on: When the monitor has been connected to AC power supply, press this
key to turn on the monitor.
◼ Power off: In power on state, press and hold this key for two seconds to turn off the
monitor.
◼ The key integrates indicator, which is lit when the monitor is turned on and off
when the monitor is turned off.
5. AC power indicator
◼ On: The monitor has been connected to AC power.
◼ Off: The monitor has not been connected to AC power.
6. Battery indicator
◼ On: The battery is being charged or has been fully charged.
◼ Off: The battery has not been installed, or the battery has been installed but the AC
power is not connected and the monitor is not turned on.
◼ Flashing: The monitor is being powered by the battery.
7. Silence key: Press this key to turn off/resume the alarm sound of the system.
8. NIBP measurement start / stop key: press this key to start / stop the measurement of non-
invasive blood pressure.
9. Freeze key: Press this key to freeze / unfreeze the wave.
10. Print key
11. Shuttle
Shuttle can be used to perform the following operations:
◼ Rotate: Rotate clockwise or counterclockwise to move the focus.
◼ Press: Press the knob to perform an action, such as access to a menu or execute a
command.

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Fig. 2-4 Front View (PAVO)

1. Power on / off button(①)

◼ Power on: When the monitor has been connected to AC power supply, press this
key to turn on the monitor.
◼ Power off: In power on state, press and hold this key for two seconds to turn off the
monitor.
◼ The key integrates indicator, which is lit when the monitor is turned on and off
when the monitor is turned off.
2. Battery indicator(②)
◼ On: The battery is being charged or has been fully charged.
◼ Off: The battery has not been installed, or the battery has been installed but the AC
power is not connected and the monitor is not turned on.
◼ Flashing: The monitor is being powered by the battery.
3. Adaptor indicator(③)
◼ On: The monitor has been connected to AC adaptor
◼ Off: The monitor has not been connected to AC adaptor
4. Silence key(④): Press this key to turn off/resume the alarm sound of the system.

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5. Freeze key or print key(⑤):

◼ Press this key to start/stop printing waveform or data.
◼ Press this key to freeze / unfreeze the wave.
6. NIBP measurement start / stop key(⑥): Press this key to start / stop the measurement of
non-invasive blood pressure.
7. Admitting patient or menu(⑦)
◼ Admitting a patient key: Press to pop-up quick admitting patient menu.
◼ Menu: Press to pop-up “menu”
8. Display(⑧)
9. Shuttle(⑨)
Shuttle can be used to perform the following operations:
◼ Rotate: Rotate clockwise or counterclockwise to move the focus.
◼ Press: Press the knob to perform an action, such as access to a menu or execute a
command.
10. Alarm indicator(⑩)
The alarm indicator indicates the levels of physiological alarms and technical alarms in
different colors and flashing frequencies:
◼ High: red, fast flashes
◼ Medium: yellow, slow flashes
◼ Low: yellow, lit without flashing.

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2.2.2 Side View

Fig. 2-5 Side View (CETUS x12, CETUS x15, CETUS xL)

1. ECG —— ECG cable interface

2. SpO2 ——SpO2 cable interface

3. T1 —— Temperature probe interface

4. T2 —— Temperature probe interface

5. NIBP —— NIBP cuff interface

6. Movable handle

7. SD card slot

8. Fan outlet

9. Battery cover

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Fig. 2-6 Side View (PAVO)

1. Temp ——Temperature probe interface（①）

2. ECG —— ECG cable interface（②）

3. SpO2 ——SpO2 cable interface（③）could connected to Masimo or Stadard

SpO2

4. NIBP —— NIBP cuff interface（④）

5. Printer or printer plate（⑤）: Could install a printer (optional).

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2.2.3 Rear View

Fig. 2-7 Rear View (CETUS x15, CETUS xl)

Fig. 2-8 Rear View (CETUS x12)

1. Speaker holes
2. Auxiliary output interface (nurse call, unrealized)
3. USB interfaces (2): Connect an external storage device to upgrade the monitor software.
4. Network interface

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5. Signal input and output interface: standard DB9 interface, which can be connected to the
PC to output data or connected with a compatible device.
6. Display interface: Connected to a standard color VGA monitor for auxiliary display and
monitoring. External monitor displays the same content as the monitor display.
7. Equipotential terminal: When other devices are used in conjunction with the monitor, you
should connect the equipotential terminals of other devices and the monitor with wires to
eliminate the ground potential difference between different devices and ensure safety.
8. Power cord retaining hook
9. Hook
10. Fuse
11. AC power socket

Fig. 2-9 Rear View (PAVO)

1. Equipotential terminal: When other devices are used in conjunction with the monitor, you
should connect the equipotential terminals of other devices and the monitor with wires to
eliminate the ground potential difference between different devices and ensure safety.
2. AC adaptor socket: connect to AC adaptor: 16.8V, 1A, charge the battery of the monitor.
3. USB interfaces (2): Connect an external storage device to upgrade the monitor software.

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4. Network interface
5. Signal input and output interface: standard DB9 interface, which can be connected to the
PC to output data or connected with a compatible device.
6. Speaker holes
7. Spiracle

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2.3 Screen Display

The monitor uses high-resolution color TFT LCD, which can clearly show the physiological
parameters and waves and other information of patients and provide patient information, alarm
information, clock, monitor status and other tips. The figure below is the standard interface
(demo mode) of the monitor in the normal monitoring state.

The screen of the standard interface is divided into four areas: 1. Info area, 2. Parameter area,
3.Wave area, 4.Info tip area, 5.Smart hotkey area.

Fig. 2-6 Standard Interface (Demo Mode (CETUS x12, CETUS x15, CETUS xL))

1. Introduction of info area (1)

The info area includes patient information, alarm status icon, physiological alarms and
technical alarms from left to right.
2. Introduction of parameter area (2)
It consists of small parameter areas, which show the corresponding parameter
measurement value and current upper and lower alarm limits of each parameter module.
The parameters are shown in fixed positions, that is, from top to bottom and from left to
right:
◼ ECG parameter area
◼ NIBP parameter area
◼ SPO2 and PR parameter area
◼ TEMP parameter area
◼ RESP parameter area
3. Introduction of wave area (3)
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It mainly displays the waves of physiological parameters, and upper left corner of each
wave shows the wave name.
4. Introduction of info tip area (4)
Display the current time, freezing information, battery status, network status, etc.; in
DEMO mode, it displays [DEMO].
5. Introduction of smart hotkey area (5)
The smart hotkey area shows the hotkeys, which are mainly used for some common
operations; see 2.4 for details.

Fig. 3-4 Standard Interface (Demo Mode (PAVO))

1. Introduction of info area (○,1)

The info area includes patient information, alarm status icon, physiological alarms and
technical alarms from left to right.

2. Parameter area and wave area (○,2)

It consists of small parameter areas, which show the corresponding parameter

measurement value and current upper and lower alarm limits of each parameter module.
The parameters are shown in fixed positions, that is, from top to bottom and from left to
right:
◼ ECG parameter area
◼ NIBP parameter area

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◼ SPO2 and PR parameter area

◼ TEMP parameter area
◼ RESP parameter area
3. NIBP list (③)
Display the measurement result of NIBP.
4. Introduction of smart hotkey area (④)
The smart hotkey area shows the hotkeys, which are mainly used for some common
operations; see 2.4 for details.

2.4 Smart Hotkeys

Smart hotkeys are some graphics hotkeys displayed at the bottom of the main screen of the
monitor, and enable you to use certain features conveniently.

The smart hotkeys at the bottom of the main screen are divided into fixed smart hotkeys and
removable smart hotkeys.

There are five fixed smart hotkeys, of which the names or features are:

[Pause]: Alarm pause

[Left]: Slide left to show more smart hotkeys

[Right]: Slide right to show more smart hotkeys

[Main]: Return to the main interface

[Menu]: Main menu

There are ten removable smart hotkeys:

[Pat.Set]: Patient info setting key

[NIBP]: NIBP measurement start / stop key

[Event]: Manual event

[Print]: Print key

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[Switch]: Interface switch key

[Freeze]: Freeze key

[Ala.Set]: Alarm setting key

[Silence]: Silence key

[Review]: Review key

[Vol.Set]: Volume setting key

2.5 Product Configuration and differences

Feature PAVO CETUS x12 CETUS x15 CETUS xL

Display size 8.4 inch 12.1 inch 15.6 inch 15.6 or
18.5 inch
Housing material plastic plastic plastic metallic
Touch screen ○ ○ ○ ●
ECG ○ ● ● ●
SPO2 ● ● ● ●
NIBP ● ● ● ●
TEMP ○ ● ● ●
RESP ● ● ● ●
CO2 ○ ● ● ●

Remark : “○”indicates that this function is optional available “●”indicates that this
function is standard

2.6 Residual Risks

The Multi-Parameter Patient Monitors are monitoring instruments, which monitor patients, and
measure ECG, non-invasive blood pressure, oxygen saturation, body temperature, respiration and pulse
rate. According to the requirements and regulations of ISO 14971:2016, hazards have been identified
based on the intended use and rated according to probability of occurrence and severity of harm. Risk
control measures have been identified to reduce the risks as low as reasonably possible.

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Chapter 3. Basic Operation

3.1 Installation

Note

⚫ To ensure normal working of the monitor, read this chapter before use, and install as
required.

Warning
⚫ All analog and digital devices connected to the monitor must be certified by IEC standards
(e.g., IEC 60950 Data Processing Equipment Standard and IEC 60601-1 Medical Equipment
Standard). Furthermore, all configurations shall comply with valid version of IEC 60601-1
standard. The personnel connecting additional devices to the input / output signal ports are
responsible for the compliance with IEC 60601-1 standard. If there is any question, please
contact aXcent.
⚫ If the patient cable interface and network interface are connected with multiple devices, the
total electric leakage cannot exceed the allowable value.
⚫ The copyright of the monitor software belongs to aXcent. Without permission, any
organization or individual shall not interpolate, copy or exchange by any means or form.
⚫ When the monitor is combined with other devices, it must comply with IEC60601-1, and
shouldn’t be connected with multi-socket wire board or extension cord.

3.1.1 Unpacking

Before unpacking, please check the box carefully. If any damage is found, please contact the
carrier immediately. Unpack properly, take out the monitor and accessories carefully, and check
the accessories according to the packing list. Check for any mechanical damage and if the items
are complete. If there is any question, please contact our sales department or dealer.

Note

⚫ Please keep the packing box and material for use in future transporting or storage.

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3.1.2 Environmental Requirements

The storage, transport and use of the monitor must meet the following environmental
requirements.

Working Ambient 5℃~40℃

environment temperature range
Relative humidity ≤85%
range
Atmospheric 70kPa~106kPa
pressure range
Supply voltage Supply voltage a.c.100V~240V，d.c.11.1V
requirement Power frequency 50Hz/60Hz
Input power 40VA-60VA
Fuse FUSE T 1.6A
Transportation Prevent severe shock, vibration, rain and snow splashing during transport.
Storage The packaged monitor should be stored in well-ventilated room with ambient
temperature -20℃~+55℃, relative humidity lower than 10%-95%,
atmospheric pressure 50kPa~106kPa, and without corrosive gases.

The operating environment of the monitor should avoid noise, vibration, dust, corrosive or
flammable and explosive materials. In order to allow air flowing smoothly and achieve good
heat dissipation, at least 2 inches (5cm) clearance should be kept around the device.

When the device is moved from one environment to another, the device may have condensation
due to differences in temperature or humidity. In this case, wait until the condensation
disappears before using the device.

Warning
⚫ Please ensure that the device operates under stipulated environment, or else technical
specifications declared in this Manual may not be met, and it may result in damage to
equipment and other unforeseen consequences.

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3.2 Connecting to AC Power

Connect to AC power in the following steps:

◼ Make sure that the AC power supply meets the following specifications: AC 100V ~ 240V,
50/60Hz.
◼ Use the power cord provided with the monitor. Plug the power cord into the power
connector of the monitor, and plug the other end of the power cord into the mains (low
voltage power supply network facilities) power outlet with protective earthing.

Note

⚫ Connect the power cord to the dedicated outlet in the hospital.

3.3 Turning on

3.3.1 Checking the Monitor

◼ Before turning on, check whether there is mechanical damage to the monitor, and whether

the external cables and accessories are connected correctly.

◼ Plug the power cord into the AC power outlet. If using battery power, make sure the

battery is fully charged.

◼ Check all the functions required for patient monitoring to make sure that the monitor

works properly.

Warning
⚫ If the monitor is damaged, or fails to work normally, do not use it for patient monitoring.
Please contact the maintenance personnel or aXcent immediately.

3.3.2 Starting the Monitor

After checking the monitor, you'll be ready to start the monitor.

Press the power switch, the yellow and red warning lights flash once in turn, and the system
enters the program reading interface; then the company's LOGO is shown; finally, the system
makes a “tick” sound, the boot screen disappears, and the system enters the main interface.

If the yellow and red warning lights flash once in turn when the device is turned on and the
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monitor makes a “tick” sound, the warning system of the monitor can work normally.

Notes

⚫ If any fatal error occurs during self-test, the system will alarm.

⚫ Check all available monitoring functions to ensure that the monitor functions properly.

⚫ If the monitor integrates a battery, charge the battery after each use to secure sufficient
power.

3.3.3 Connecting the Sensor

Connect the required sensor to the monitor and the monitoring position on the patient.

Note

⚫ For proper connections and related requirements for a variety of sensors, see Chapters
7-12.

3.3.4 Starting Monitoring

Start monitoring in the following steps:

◼ Check if the patient cable and the sensor are connected properly.

◼ Check if the settings of the monitor are correct, such as: patient category [Patient Cat.]

◼ For the details of parameter measurement or monitoring, see the appropriate section.

3.4 Turning off

Please turn off the monitor in the following steps:

◼ Disconnect the cables and sensors connected to the patient.

◼ Press and hold the power switch for two seconds to pop up the 5sec countdown window,

and the monitor turns off in five seconds.

Caution
⚫ If the monitor cannot be turned off properly or special cases occur, you can simply
disconnect the power to force shutdown. However, forced shutdown may cause data loss, and
is not recommended.

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3.5 Basic Operation

3.5.1 Using the Shuttle

Shuttle can be used to perform the following operations:

◼ Rotate: Rotate clockwise or counterclockwise to move the focus.

◼ Press: Press the shuttle to perform an action, such as access to a menu or execute a

command.

Shuttle is the main control key. On the interface or the menu, the green highlighted box that
moves with the knob turning is called the cursor. By turning the shuttle, you can position the
cursor in order to perform the desired operation.

3.5.2 Using Keys

The monitor has three types of keys:

◼ Soft keys: The position that the cursor can stay on the interface, allowing quick access to

certain menus or performing certain actions, including:

◆ Parameter hotkey: Select a parameter area and enter the appropriate parameter
setup menu.

◆ Wave hotkey: Select a wave area and enter the appropriate parameter setup menu.

◆ Smart hotkey: The shortcut keys that the user can operate quickly at bottom of the
screen; see “Smart Shortcuts” for details.

◼ Hard keys: The physical keys on the monitor, such as the alarm silence key on the front

panel.

◼ Popup keys: Menu keys relevant to the tasks that automatically appear in the monitor

screen when needed. For example: the confirmation key popped up when you need to

confirm the change.

3.5.3 Using the Touch Screen

You can directly click on the touch screen (optional) to quickly and easily accomplish some
operations.

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3.5.4 Using Soft Keyboard

Click on the edit box, and the system will display the soft keyboard on the screen; you can turn
the shuttle or use the touch screen to select characters one by one, and input data. Use the Back
key to delete a single character; use the Enter key to confirm that you have finished entering
and close the soft keyboard.

3.5.5 Using Menu

Select the [Menu] key on the monitor interface via the shuttle or directly the touch screen

to open the [Main Menu] as shown below. Through the main menu, you can complete most of
the operations and settings.

Fig. 3-1 [Main Menu]

The style of other menus is basically similar to the [Main Menu], and generally consists of the
following components:
◼ Menu title: a summary of the current menu.
◼ Close menu: Close the current menu, exit the current menu or close the current menu and
return to the previous menu.
◼ Main display area: display options, buttons or prompt messages. The symbol ">>"
indicates that selecting this option can enter the corresponding submenu.
◼ Confirmation key area: Some menus contain a confirmation key area to confirm the menu
operations, including confirmation and cancel key.
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3.6 Operating Mode

The monitor has 2 operating modes, of which the demo mode is protected by a password.

1. Monitoring mode (operating mode)

This is the daily operating mode of patient monitoring; you can change some settings in
accordance with the patients, such as alarm limits. However, when the patient is
discharged, the monitor will restore these settings to default according to pre-set
configuration.

2. Demo mode

This mode is protected by a password (default: 8888) for demonstration purpose only.

◼ Enter the demo mode:

◆ Select [Menu] Smart Hotkey→[Main Menu];

◆ Select [Demo >>] → enter the password and confirm, and the monitor enters
the demo mode.

◼ Exit demo mode:

◆ Select [Menu] Smart Hotkey→[Main Menu];

◆ Select [Exit Demo >>] and the monitor exits the demo mode.

Warning

⚫ The demo mode is mainly used to show the machine performance and for user training.
In actual clinical use, the demo function is prohibited in order to avoid mistaking the
displayed waves and parameters as those of the patient, thus affecting patient
monitoring, and delaying diagnosis and treatment.

3.7 Measurement Setup

This section only describes the general settings of measuring wave in monitor mode; for other
specific settings of each parameter, please refer to the appropriate section.

Click the wave area of a parameter to enter the appropriate setup menu. The setup menu defines
the specific wave setup of the parameter, such as wave gain and wave speed; you may set the

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waves of different parameters as needed.

3.8 Freezing Waves

In the patient monitoring process, you can freeze the wave on the screen, review and carefully
observe the patient's condition during this time. Freeze / unfreeze the wave as follows:

Select [Freeze] hotkey to freeze the displayed wave of the monitor.

Click [Freeze] hotkey again to release the freezing state.

3.9 Other Common Setup

The common setup of the monitor is the general setup that defines how the monitor works, for
example: alarm volume setting. They may affect the setup of multiple measurements or display
interfaces.

3.9.1 Defining the Monitor

When install the monitor or change the usage occasion, the monitor should be defined as
follows:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

◆ Select [Device Name]: Enter device name through the soft keyboard on the screen.

◆ Select [Department]: Enter the sector and department using the device through the
soft keyboard on the screen.

◆ Select [Bed No.]: Enter the bed number through the soft keyboard on the screen.

3.9.2 Language Setup

Set the monitor language in the following steps:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

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◼ Select [Language], and select the option as needed:

◆ [English]: The interface language of the monitor is English.
◆ [Spanish]: The interface language of the monitor is Spanish.
◆ [PYCCKNN]: The interface language of the monitor is Russian.
◆ [Francais]: The interface language of the monitor is French.
◆ [Turkce]: The interface language of the monitor is Turkish.
◆ [Chinese]: The interface language of the monitor is Chinese.
◆ [Portugues]: The interface language of the monitor is Portuguese.
◆ [Deutsch]: The interface language of the monitor is German.
◆ [Polskie]: The interface language of the monitor is Polish.
◆ [Romania]: The interface language of the monitor is Romanian.
◆ [Italia]: The interface language of the monitor is Italian.

3.9.3 Date and Time

Set the monitor time in the following steps:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>] → enter [User Maintenance] menu;

◼ Select [Time Setup >>] → enter [Time Setup] menu;
◼ Select [Date Format], and set the date format in accordance with custom
◆ [YYYY-MM-DD]: Year - Month - Day.
◆ [MM-DD-YYYY]: Month - Day - Year.
◆ [DD-MM-YYYY]: Day - Month - Year.
◼ [Date]: Set the year, month, and day.
◼ [Time]: Set the hour, minute and second.

3.9.4 Volume Control

1. Alarm volume

◼ Select Vol.Set smart hotkey → [Volume Setup] menu;

◼ Select [Alarm Vol]: Set [Y]. Y is X~9, X is the minimum volume, and Y value plus /
minus 1 when turning the shuttle once.

2. Key-pressing volume

◼ Select Vol.Set smart hotkey → [Volume Setup] menu;

◼ Select [Key Volume]: [N]. N value ranges from 0 to 9, plus / minus 1 when turning

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the shuttle once, select 0 to turn off the key-pressing tone, and select 9 to set to the
maximum volume.

3. QRS volume

Select Vol.Set smart hotkey → [Volume Setup] menu;

Select [QRS Volume]: [M]. M values ranges from 0 to 9, plus / minus 1 when turning the
shuttle once, select 0 to turn off the key-pressing tone, and select 9 to set to the maximum
volume.

3.9.5 Setting Parameter Unit

You can select a preferred unit through the following operations

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

◼ Select [Unit Setup >>] → [Unit Setup] menu;
◆ Select [Height], and select the unit [cm] / [inch] as needed.
◆ Select [Weight Unit], and select the unit [kg] / [lb] as needed.
◆ Select [Press.Unit], and select the unit [mmHg] / [kPa] as needed.
◆ Select [Temp Unit], and select the unit [°C] / [°F] as needed.

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Chapter 4. Patient Information

Management

Connect the patient to the monitor, and the monitor will display and store the physiological
data of the patient, so the patient can be monitored without admitting the patient. However,
admitting the patient correctly is very important.

If the monitor has admitted the patient, it is recommended to operate the monitor to discharge
the current patient before connecting to (not admitted) the next patient. Otherwise, the data of
the previous patient will be stored in the data of the current patient.

Warning
⚫ Whether the patient is admitted or not, the system will give a default value to [Patient Cat.]
and [Paced], and the user must confirm that the default value is appropriate for the patient
being monitored.

⚫ For patients with pacemakers, [Paced] must be set to [Yes]. Otherwise, the pacing pulse will
be treated as normal QRS wave group, and the system is unable to detect the alarm status of
[ECG Signal weak].

⚫ For patients without a pacemaker, [Paced] must be set to [No]. Otherwise, the system is
unable to detect the arrhythmias (including PVCs count) related to ventricular premature
beats, and fails to perform ST segment analysis.

4.1 Patient Setup Menu

You can manage the patients through the [Patient Setup] menu; to enter the [Patient Setup]
menu, operate as follows:

Select [Menu] Smart Hotkey→ [Main Menu];

Select [Patient Setup >>] → [Patient Setup] menu, as shown in Fig. 4-1.

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Fig. 4-1 Patient Info Setting

4.2 Admitting a Patient Quickly

Admit a patient quickly as follows:

In [Patient Setup] menu, select [Quick Admit] → [Warning] menu → [OK] → [Quick Admit]
menu, which is shown below:

Fig. 4-2 Quick Admitting Menu

◼ Select [Patient Cat.], and set the patient category as needed:

◆ [Adu]: Adults.
◆ [Ped]: Pediatric.

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◼ Select [Paced], and set whether the patient wears a pacemaker according to the patient
condition:
◆ [Yes]: The patient wears a cardiac pacemaker.
◆ [No]: The patient does not wear a cardiac pacemaker.

After setting, select [OK] to save the current setup; select [Cancel] and do not save the
current setup.

4.3 Admitting a Patient

To admit a patient, operate as follows:

In the [Patient Setup] menu, select [Admit Patient] → [Warning] → [OK] → [Patient Info]
menu, which is shown below:

Fig. 4-3 Patient Info

1. Select [SurName], and enter patient’s surname through the soft keyboard.

2. Select [Name], and enter patient name through the soft keyboard.

3. Select [Case], and enter the case number through the soft keyboard.

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4. Select [Gender], and set the patient’s gender according to the patient condition:

◆ [Male]: Males.
◆ [Female]: Females.
◆ [Others]: Others.

5. Select [Patient Cat.], and set the patient category as needed:

◆ [Adu]: Adults.
◆ [Ped]: Pediatric.
6. Select [Paced], and set whether the patient wears a pacemaker according to the
patient condition:

◆ [Yes]: The patient wears a cardiac pacemaker.

◆ [No]: The patient does not wear a cardiac pacemaker.

7. Select [High (cm)], and set the patient’s height via the pop-up keyboard on the
screen.
8. Select [Weight (kg)], and set the patient’s weight via the pop-up keyboard on the
screen.
9. Select [Blood Type], and set the patient’s blood type:

◆ [A]: Patient blood type is A.

◆ [B]: Patient blood type is B.
◆ [AB]: Patient blood type is AB.
◆ [O]: Patient blood type is O.
◆ [Others]: Other blood type of the patient.

10. Select [Admit date (yyyy-mm-dd)], and set the date of admitting the patient.
11. Select [Birthday (yyyy-mm-dd)], and set the birth date of the patient.

After setting, select [OK] to save the current setup; select [Cancel] and do not save the
current setup.

4.4 Editing Patient Info

When the monitor has admitted a patient, but the patient information is incomplete, or needs
to be changed:

Select the patient info area on the display to pop up [Patient Info] menu as shown in Fig. 4-3,
and complement or change the patient info in the [Patient Info] menu; see 4.2 for specific
operation.
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4.5 Discharging a Patient

To discharge a patient, operate as follows:

In the [Patient Setup] menu, select [Discharge Patient] → [Warning] → [OK] to finish the
operation of discharging a patient.

After the patient is discharged, all the information of the patient stored by the monitor will be
cleared. Therefore, discharge the patient only when needed.

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Chapter 5. User Interface

The monitor has four working interfaces, which are “Normal Screen”, “Big Numerics”, “ECG
7-Lead Half-Screen”, “ECG 7-Lead Full-Screen” and “ECG 12-Lead Full-Screen”. The user
can select the working interface according to needs, and get different screen information.
Below describes the working interfaces.

5.1 Selecting User Interface

Select the user interface as follows:

◼ Select [Switch] smart hotkey→[Screen Setup];

◼ Select [Screen Select], and select the user interface according to needs:

◆ [Normal Screen]: Standard interface.

◆ [Big Numerics]: Big font interface.
◆ [ECG 7-Lead Half-Screen]: ECG 7-lead half-screen.
◆ [ECG 7-Lead Full-Screen]: ECG 7-lead full screen
◆ [ECG 12-Lead Full-Screen]: ECG 12-lead full screen(Optional)
◆ [OxyCRG Screen]: OxyCRG interface
◆ [DynaTrend Screen]: DynaTrend interface

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5.2 Interface Introduction

5.2.1 Normal Screen

Fig. 5-1 Normal Screen

The normal screen provides the parameter wave being monitored and the parameters displayed
in the parameter area. This is the basic working interface of the monitor. The interface displays
all parameters, two ECG waves, one blood oxygen binding capacity scan wave, and one
respiratory wave.

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5.2.2 Big Numerics

Fig. 5-2 Big Numerics Screen

Big Numerics screen allows observing other parameters except the body temperature, one ECG
wave, one respiratory wave, and one blood oxygen binding capacity scan wave.

5.2.3 ECG 7-Lead Half-Screen

Fig. 5-3 ECG 7-Lead Half-Screen

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ECG 7-Lead Half-Screen allows observing all parameters, seven ECG waves (I, II, III, AVR,
AVL, AVF, V), one blood oxygen binding capacity scan wave, and one respiratory wave.

5.2.4 ECG 7-Lead Full-Screen

Fig. 5-4 ECG 7-Lead Full-Screen

This interface allows observing all parameters, and seven ECG waves (I, II, III, AVR, AVL,
AVF, V) simultaneously.

5.2.5 ECG 12-Lead Full-Screen

Fig. 5-5 ECG 12-Lead Full-Screen

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This interface allows observing all parameters, and twelve ECG waves (I, II, III, AVR, AVL,
AVF, V1, V2, V3, V4, V5, V6) simultaneously.

5.2.6 OxyCRG Screen

The Respiratory Oxygenation graph screen is shown below

Fig. 5-6 OxyCRG Screen

The respiratory oxygenation diagram interface occupies the lower half of the waveform area and is
composed of HR trend, SpO2 trend, and compressed respiratory wave or RR trend. There are 2 hot
keys below: trend time length and compressed breath / RR trend.
1. Trend time length
You can select the length of time: 1 minute, 2 minutes, 4 minutes
2. Respiratory wave / RR trend
You can toggle the display of [Respiratory Wave] or [RR Trend]

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5.2.7 DynaTrend Screen

The DynaTrend screen is shown below:

Fig. 5-7 DynaTrend Screen

Dynamic short trends are located on the right side of the waveform area, showing trends for a
range of parameters over the most recent period. The top of each trend graph shows the trend of
the parameter name, the right shows the scale, below shows the time.

The trend time, the right scale, the parameter name can be changed manually: select any parameter
trend area, select 【Parameter】, 【Trend Time】, 【Standard】 and 【Reference】 in the
【Short Trend Setting】 menu. [Maximum value].

The respiratory oxygenation diagram interface occupies the lower half of the waveform area and is
composed of HR trend, SpO2 trend, and compressed respiratory wave or RR trend. There are 2
hot keys below: trend time length and compressed breath / RR trend.

1. Trend time length

You can select the length of time: 1 minute, 2 minutes, and 4 minutes

2. Respiratory wave / RR trend

You can toggle the display of [Respiratory Wave] or [RR Trend]

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Chapter 6. Alarm

Alarm means that the monitor prompts the medical staff through sound and light when the
patient being monitored has abnormal changes in vital signs or the monitor has a failure and
unable to monitor the patient successfully.

Warning
⚫ In any single region (e.g. ICU), it has potential dangers if the same or similar devices use
different alarm setups.

Note

⚫ After setting, the alarm and other parameters of the monitor won’t be lost when the system
power is cut off, unless modified manually; connect the power again (external and internal)
and turn on the monitor, it will resume normal working, and the alarm and other parameters
remain unchanged.

6.1 Alarm Type

According to the nature of the alarm, the alarms of the monitor can be divided into
physiological alarms, technical alarms and prompt messages.

◼ Physiological alarms

A physiological alarm is usually triggered when a physiological parameter of the patient

exceeds the alarm limit or the patient has physiological abnormalities. The information of
physiological alarm is displayed in the physiological alarm area on top of the screen.

◼ Technical alarms

Technical alarm is also known as a system error message, which is caused by improper
operation or system failure resulting in system malfunction or monitoring result distorted. The
information of technical alarm is displayed in the technical alarm area on top of the screen.

◼ Prompt messages

Strictly speaking, the prompt messages are not alarms. The monitor also will display some
information associated with system status in addition to the physiological alarms and technical
alarms, and generally such information do not involve the patient's vital signs. The prompt

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messages generally appear in the technical alarm area and parameters area.

6.2 Alarm Level

According to the severity of the alarm, the physiological alarms of the monitor can be divided
into high level, medium level and low level.

◼ High level alarms

The patient is in critical condition that is life-threatening, and should be immediately rescued;

Or the monitor has a serious mechanical failure or malfunction, causing it unable to detect the
patient's critical state and endangering the patient’s life.

◼ Medium level alarms

The patient's physiological signs are abnormal, and appropriate measures or treatment should
be taken immediately;

Or although it won’t endanger the patient’s life, the mechanical failure or misoperation of the
monitor will affect the normal monitoring of key physiological parameters.

◼ Low level alarms

The patient's physiological signs are abnormal, and appropriate measures or treatment may
need to be taken;

Or certain monitoring function is invalid due to mechanical failure or misoperation, but it won’t
endanger the patient’s life.

The levels of all technical alarms and some physiological alarms have been set in the monitor
at the factory and cannot be modified by the user. The levels of some physiological alarms can
be modified.

6.3 Alarm Mode

When an alarm occurs, the monitor uses the following audible or visual alarm to prompt the
user:

◼ Light alarm
◼ Audible alarm

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◼ Alarm info
◼ Parameter flashing

Of which, the light alarm, audible alarm, and alarm info distinguish the alarm levels in a
different manner respectively.

6.3.1 Light Alarm

When an alarm occurs, the alarm indicator will flash in different colors and frequencies to
prompt the alarm level.

◼ High level alarm: Red, fast flashes

◼ Medium level alarm: Yellow, slow flashes
◼ Low level alarm: Yellow, lit without flashing

6.3.2 Audible Alarm

An audible alarm is that the monitor prompts the alarm levels with different sound
characteristics when an alarm occurs.

◼ High level alarm: Beep - beep - beep -- beep - beep ---- beep - beep - beep -- beep - beep
◼ Medium level alarm: Beep - beep - beep
◼ Low level alarm: Beep

6.3.3 Alarm Info

Alarm info refers to that the physiological or technical alarm area of the monitor will display
the corresponding alarm information when an alarm occurs. The system will distinguish the
alarm levels with different background colors:

◼ High level alarm: Red

◼ Medium level alarm: Yellow
◼ Low level alarm: Yellow

The following flags in front of physiological alarms are used to distinguish the alarm levels:

◼ High level alarm: ***

◼ Medium level alarm: **
◼ Low level alarm: *

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6.3.4 Parameter Flashing

When a physiological parameter of the patient alarms, the parameter values in the parameter
area will flash once per second, and the upper limit and lower limit of the parameter will also
flash at the same frequency, indicating that the parameter exceeds the upper limit or lower limit.

6.4 Alarm States

In addition to the above alarm modes, you can also set the monitor to the following four alarm
states as needed, and display different alarm icons on the screen:

◼ Alarm silence

◼ Alarm sound off

◼ Alarm pause

◼ Alarm off

6.4.1 Silence

Select [Silence] smart hotkey, and you can temporarily turn off the alarm sound of
currently occurring physiological alarms of the monitor, but the alarm information is still
retained. For technical alarms, clear the alarm state, display alarm prompt information only

and the monitor enters alarm silence state, and the alarm state icon area displays the icon.

When a new physiological alarm or technical alarm occurs, the alarm silence is automatically
canceled.

6.4.2 Alarm sound off

The alarm sound can be turned off through the following operations:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>] → [User Maintenance] menu;

◼ Select [Alarm Param >>] → [Ala.Para Setup] menu;
◼ Set [Min Alarm Vol] to [0];

◼ Select [Vol.Set] smart hotkey → [Volume Setup] menu;

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◼ Set [Alarm Volume] to [0].

When the alarm sound is turned off, the alarm state area on the screen shows the icon.

If [Min Alarm Vol] is larger than 0, the system will cancel alarm sound off state.

6.4.3 Alarm Pause

Press the [Pause] smart hotkey to temporarily stop the alarm of the monitor in the
following steps:

◼ Alarm state icon area will display the icon.

◼ The light alarm and audible alarm of the physiological alarms are suspended, and the
alarm information is not displayed.
◼ The remaining time of alarm pause is displayed in the physiological alarm area.
◼ Alarm parameters and upper / lower limit stop flashing.
◼ The audible alarm and light alarm of technical alarms are suspended, but the alarm
message is still displayed.

After the alarm pause is finished, the monitor will automatically cancel the alarm pause state.
During the alarm pause, you can also press [Pause] smart hotkey to manually cancel the
alarm pause.

You can set the alarm pause time as follows:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

◼ Select [Alarm Param >>] → [Ala.Para Setup] menu;
◼ Select [Alarm Pause Time], and set the alarm pause time as needed:
◆ [1min] / [2min] / [3min] / [4min] / [5min] / [10min] / [15min]: Set the alarm pause
time to 1 min, 2 min, 3 min, 4 min, 5 min, 10 min or 15 min. By default, the alarm
pause time is 2 minutes.
◆ [Permanent]: Set the alarm pause time to permanent.

6.4.4 Alarm off

As shown in 6.4.3, if the [Alarm Pause Time] is set to [Permanent], press the [Pause]

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smart hotkey, and the monitor will turn off the alarm. In this case, except the alarm prompt
characteristics maintained in alarm pause state:

◼ Alarm state icon area will display the icon.

◼ The physiological alarm area displays [Alarm Pause].

You can press the [Pause] smart hotkey again to manually cancel the alarm off.

If the monitor is in the alarm state of suspension or closure of senior technical alarm is triggered,
the alarm and the alarm off pause are automatically canceled.

Warning
⚫ When the alarm volume is set to 0 or the alarm pause time is set to permanent, the monitor does not sound an
alarm when an alarm occurs. Therefore, the operator should use this feature carefully.

6.5 Alarm Setup

6.5.1 Setting the Alarm Sound

See 3.9.4 Volume Control for the method to set the alarm volume.

6.5.2 Setting the Alarm Delay Time

For over-limit alarm of continuous measurement parameter, you can set the alarm delay time.
If the alarm condition disappears during the delay period, the monitor won’t alarm. In
[Ala.Param Setup] menu, select [Alarm Delay] time and [ST Alarm Delay] time.

The specific operation is as follows:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>] → [User Maintenance] menu;

◼ Select [Alarm Param >>] → [Ala.Param Setup] menu;
◼ Select [Alarm Delay], and set the alarm delay time as needed:
◆ [Off]: Turn off the alarm delay.
◆ [1s] / [2s] / [3s] / [4s] / [5s] / [6s] / [7s] / [8s]: Alarm delay time is 1 sec, 2 sec, 3
sec, 4 sec, 5 sec, 6 sec, 7 sec or 8 sec. By default, the alarm delay time is 4 seconds.
◼ Select [ST Alarm Delay], and set the ST alarm delay time as needed
◆ [Off]: ST alarm delay is off
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◆ [10s] / [20s] / [30s] / [45s] / [1min] / [2min] / [3min]: ST alarm delay time is 10 sec,
20 sec, 30 sec, 45 sec, 1 min, 2 min or 3 min. By default, the ST alarm delay time is
20 seconds.

The system sets physiological alarm delay time and also sets 1~2s delay time after technical
alarm been triggered. Normally the delay time is limited to 5s.

6.5.3 Setting a Parameter Alarm

With SpO2 for example, select the SpO2 parameter area, select [Alarm Setup >>] in the
popup [SpO2 Setup] menu to enter the SpO2 alarm setup interface.

1. Turn on / off alarm

◼ Select [Alarm Switch] and set the alarm switch as follows:

◆ [On]: Turn on SpO2 alarm; when the parameter alarm occurs, the monitor will
prompt according to the set alarm level.

◆ [OFF]: Turn off SpO2 alarm; icon is displayed in the parameter area, and the

monitor won’t prompt the parameter alarm.

2. Set the alarm level

◼ Select [Alarm Level], and set the alarm level as follows:

◆ [Low]: Set the alarm level to low.

◆ [Mid]: Set the alarm level to medium.
◆ [High]: Set the alarm level to high.

3. Set the alarm limit

In any cases, the alarm system only allows setting the values within the effective range of the
system, and the upper alarm limit must be higher than the lower alarm limit.

◼ Select [Spo2 Low Limit] and set the lower limit of SpO2 alarm.

◼ Select [Spo2 High Limit] and set the upper limit of SpO2 alarm.

4. Restore default alarm setup

◼ Select [Default], and restore the alarm setup to the factory default.

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Note

⚫ When setting the upper and lower alarm limit, confirm the patient category to be adults or
pediatric, and set its scope according to the clinical need. If the setting exceeds the alarm
limit, the alarm system will fail easily.
⚫ When the alarm limit is turned on, and the upper and lower alarm limits are manually set, the
instrument will display the upper and lower alarm limits continuously, and the initial alarm
preset value won’t be provided additionally.

6.6 Latch Alarm

Physiological alarms can be set to [Latching] or [No latching].

◼ [Latching]: Even if the cause of physiological alarm is cleared, the system will still be
“latched”, that is, continue to display the alarm information corresponding to
physiological alarm, the alarm sound also continues, but the alarm mode has the following
changes:

◆ Parameters and upper or lower alarm limit are no longer flashing.

◆ Display the time that the latest alarm was triggered after the alarm message in the
physiological alarm area.

◼ [No latching]: After the causes of physiological alarm are cleared, the system will no

longer prompt the physiological alarm.

The default alarm of the system is non-latching alarm; you can set the alarm as latching or
non-latching in the following steps:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

◼ Select [Alarm Param >>] → [Ala.Param Setup] menu;
◼ Select [Latching Alarms], and set the alarm as needed:

◆ [Latching]: Latching alarm.

◆ [No latching]: Non-latching alarm.

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6.7 Manual Event

In the patient monitoring process, some events may have an impact on the patient, resulting
in changes of some monitoring waves or parameters. In order to assist in the analysis of these

effects, you can manually record these events through the [Event] smart hotkey, and

then view it in the event review; refer to13.4 Event Review for detailed operation.

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Chapter 7. ECG

7.1 Overview

Electrocardiogram (ECG) is produced by the continuous electrical activity of the patient's

heart, and displayed with waves and numerics on the monitor in order to accurately assess the
physiological state of the patient at the time. The ECG cable should be connected properly, so
as to obtain a correct measurement value and normal display. This monitor can
simultaneously display up to 12-Lead ECG waveforms.

Patient cable consists of two parts:

◼ Wires connected to the monitor

◼ ECG device connected to the patient

Connect to the monitor with five lead ECG cable, and ECG can display two different waves
by adjusting the two leads. You can use the shuttle to change the lead name on the left of the
ECG wave on the screen and select the lead to be monitored.

The parameters displayed in the parameter area of the monitor include heart rate (HR), ST
segment measurements and arrhythmia counts per minute.

All these parameters can be used as alarm parameters.

Note

⚫ In the factory setup of this instrument, ECG waves display in the first two waves from
the top in the wave area in the normal screen.

7.2 Safety Information

Warning
⚫ To monitor ECG signal with this monitor, ECG cable and ECG electrodes specified in the
Operator’s Manual must be used.

⚫ When you connect electrodes or patient cable, make sure that the patient is absolutely not
connected with any other conductive parts or in contact with the ground. In particular, make
sure that all the ECG electrodes, including the neutral electrodes, are attached to the patient
and prevent them from contact with the conductive parts or ground.

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⚫ Periodically check the skin that the electrode is placed at; if there is any sign of allergy,
replace the electrode or change the placement position.
⚫ Electrosurgery (ESU) device interference, defibrillator discharge:

 When the patient needs defibrillation, do not use non-defibrillator type ECG
cables.
 During defibrillation, the operating personnel shall not touch the patient, tables and
instrument.
 During defibrillation, the ECG cable connected with the patient’s body may be
damaged. Check if the function is normal again before using these cables.
 Recover within 10 seconds after defibrillation and will not lose any stored data.
During electrosurgery (ESU) or defibrillation, the measurement accuracy may be
temporarily reduced. This does not affect the safety of the patient or the instrument.
 Do not expose this equipment to X-ray or strong magnetic fields (MRI).

7.3 Monitoring Steps

7.3.1 Preparation

Before placing the electrode, prepare the patient's skin in the following steps:

◼ Skin preparation: Since the skin is a poor conductor, it is very important to treat the
patient's skin for electrode placement appropriately to make good contact between the
electrode and the skin. Select the flat position with less muscles for the electrode
placement, and refer to the method below for treatment of the skin:

◆ Remove the body hair at the position for electrode placement.

◆ Gently rub the skin at the position for electrode placement to remove dead skin cells.
◆ Wash the skin thoroughly with soap and water (do not use ether and pure alcohol, as
this will increase the skin's impedance).
◆ Dry the skin completely before placing the electrode.

◼ Install the spring clip or stud prior to the placement of the electrodes.
◼ Place the electrode on the patient.
◼ Connect the ECG cable and ECG interface.

Warning
⚫ Check if the lead is normal before monitoring. When the ECG cable is unplugged, the screen
will display [ECG Lead Off] prompt, and trigger an audible and visual alarm.

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7.3.2 Selecting Lead

◼ Select the ECG parameter area or wave area → [ECG Setup] menu;
◼ Select [Other Setup >>] → [ECG Other Setup] menu;
◼ Select [Lead Type], and select the ECG lead as needed:
◆ [3-Lead]: 3-lead; ECG wave options: I, II, III.
◆ [5-Lead]: 5-lead; ECG wave options: I, II, III, AVR, AVL, AVF, V.
◆ [12-Lead](Optional): 12-lead; ECG wave options: I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5, V6.

7.3.3 Lead Name and Corresponding Color

The lead names in European standard and U.S. standard are shown in Table 7 -1.
Table 7-1: Lead Name in European Standard and American Standard

European Standard (IEC) American Standard (AHA)

Lead Name Color Lead Name Color

R Red RA White

L Yellow LA Black

F Green LL Red

N Black RL Green

C/C1 White/Red V/V1 Brown/Red

C2 White/Yellow V2 Brown/Yellow

C3 White/Green V3 Brown/Green

C4 White/Brown V4 Brown/Blue

C5 White/Black V5 Brown/Orange

C6 White/Purple V6 Brown/Purple

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7.3.4 Installing Electrodes

◼ 3-lead

The electrode placement position of 3-lead is shown in Fig. 7-1:

◆ R electrode: placed below the clavicle, near the right shoulder.
◆ L electrode: placed below the clavicle, near the left shoulder.
◆ F electrode: placed on the left abdomen.

Fig. 7-1 3-lead Connection Method

◼ 5-lead

The electrode placement position of 5-lead is shown in Fig. 7-2:

◆ R electrode: placed below the clavicle, near the right shoulder.

◆ L electrode: placed below the clavicle, near the left shoulder.
◆ N electrode: placed on the right abdomen.
◆ F electrode: placed on the left abdomen.
◆ C electrode: placed on the chest wall.

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Fig. 7-2 European 5-lead Connection Method

◼ For 5-lead configuration, place the chest (V) lead electrode in one of these locations (see
Fig. 7-3):
◆ V1 is in the fourth intercostal on the right edge of the sternum.
◆ V2 is in the fourth intercostal on the left edge of the sternum.
◆ V3 is in the middle position of V2 and V4.
◆ V4 is in the fifth intercostal of the left mid-clavicular line.
◆ V5 is in the left anterior axillary line, at the same level of V4.
◆ V6 is in the left axillary midline, at the same level of V4.
◆ V3R-V7R is in the right chest wall, corresponding to the position of the left side.
◆ VE is located on the xiphoid process. For the “V” lead placement on the back, place
the “V” electrode in one of the following locations.
◆ V7 is in the fifth intercostal of the left posterior axillary line on the back.
◆ V7R is in the fifth intercostal of the right posterior axillary line on the back.

Fig. 7-3 Chest Lead Electrode Placement Position for 5-lead

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◼ 12-Lead

12-lead ECG are using 10 electrodes, which are placed on the patient’s four limbs and chest.
The limb electrodes should be placed on the soft skin and the chest electrodes placed
according to the physician’s preference. The electrode placement position of 12-lead is
shown in Fig. 7-4:

Fig. 7-4 Chest Lead Electrode Placement Position for 12-lead

Lead Placement for Surgical Patients

The surgical site should be taken into consideration when placing electrodes on a surgical
patient. e.g. for open-chest surgery, the chest electrodes can be placed on the lateral chest or
back. To reduce artifacts and interference from electrosurgical units, the limb electrodes can
be placed close to the shoulders and lower abdomen and the chest electrodes on the left side
of the mid-chest. Do not place the electrodes on the upper arm. Otherwise, the ECG
waveform will be very small.

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Notes

⚫ To ensure patient safety, all leads must be connected to the patient.

⚫ If the electrodes are attached correctly, but the ECG wave is not accurate, then replace the
lead.

⚫ Interference from ungrounded instrument near the patient and ESU interference may cause
wave problems.

7.3.5 Checking the Pacemaking Status

Before ECG monitoring, it is very important to set the pacemaking state of the patient properly.

If the patient has a pacemaker, set [Paced] to [Yes], and the icon displays in the patient
information area. When the system detects a pacing signal, the “┃”symbol will be marked in
the top of the ECG wave.

You can change the pacing state in the following method:

◼ Select the patient information area to pop up the [Patient Info] menu;

◼ Select [Yes] / [No] for [Paced] as needed, indicating that the patient with or without
pacemaker

7.4 ECG Display

◼ ECG wave display
The monitor displays two ECG waves on the normal screen. Fig. 7-5 below is the monitoring
interface of 5-lead, and is for reference purposes only. The graphics displayed on your monitor
may be slightly different.

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Fig. 7-5 ECG Wave on Normal Screen

In addition, when [Paced] is set to [Yes], and the patient wears a pacemaker, the “┃”symbol
will be marked in the top of the ECG wave.

◼ ECG parameter display

The ECG parameter area of the monitor in the normal screen is shown in Fig. 7-6:

Fig. 7-6 ECG Parameter in Normal Screen

7.5 Alarm Setup

Select [Alarm Setup >>] → [Alarm Setup] interface to set ECG related alarms; see 6.5 Alarm
Setup for the setting method.

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7.6 ECG Setup

Click the ECG parameter area or wave ECG area to pop up the [ECG Setup] menu, which is
as shown below. You can set the ECG through the [ECG Setup] menu.

Fig. 7-7 [ECG Setup] Menu

◼ Select [HR Source], and set the heart rate source:

◆ [Auto]: Automatically select HR source.
◆ [ECG]: Select ECG monitoring as the HR source.
◆ [SPO2]: Select SpO2 monitoring as the HR source.
◼ Select [Cal.Channel] and select heart rate calculation channel.

Select [ECG1] / [ECG2] to set the display wave channel. Select ECG1/ECG2, and set the
names of upper ECG wave and lower ECG wave on the screen.

◼ ECG1/ECG2 should not be the source of the same wave.

◼ Select [ECG1 Gain] / [ECG2 Gain] and set the ECG wave gain. When the wave is
shorter, increase the wave gain factor appropriately; when the wave is high or the peak
cannot be displayed, reduce the wave gain appropriately.
◼ Select [Wave Speed], and set the wave speed.
◼ Select [Filter], and set the filter mode:

◆ [Monitor]: Monitor mode

◆ [Diagnostic]: Diagnostic mode
◆ [Surgery]: Surgery mode
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◆ [Strong]: Strong filter mode

◼ Select [Draw Wave], and set the wave drawing method as below:
◆ [Smooth]: Smooth
◆ [Ladder]: Ladder; default.

◼ Select [Relearn] to learn arrhythmia. In the following cases, you need to start arrhythmia
self-learning:
◆ In ECG monitoring process, when the patient's ECG module has larger changes,
arrhythmia self-learning should be started once.
◆ ECG module changes could cause wrong arrhythmia alarm, ST measurement lost,
and inaccurate heart rate.

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Chapter 8. Resp

8.1 Overview

Thoracic electrical bioimpedance is a method used for measuring the respiration. When the
patient is breathing, the thoracic impedance between two ECG electrodes changes due to
thoracic activity. The monitor generates a respiratory wave on the screen by measuring the
changing impedance value. The monitor calculates the respiration rate (RR) according to the
wave cycle.

8.2 Safety Information

Note

⚫ Respiration monitoring does not apply to patients with large range of activities, as this may
lead to false alarms.

Warning
⚫ Do not use anti-electric knife ECG cable for respiration monitoring.

⚫ Respiration measurement cannot identify the apnea because it will alarm if the next
respiration is not detected in the predetermined period after last respiration, and therefore it
cannot be used for diagnostic purpose.

8.3 Placing Electrodes for Respiration Monitoring

Since the skin is a poor conductor, it is very important to treat the patient's skin for electrode
placement appropriately to get better respiration signals. Refer to 7.3.1.

Respiration measurement uses standard ECG cable and electrode placement method. You can
use different ECG cables (3-lead, 5-lead). Respiratory signal is measured between two ECG
electrodes. If standard ECG electrode position is used, the two electrodes are R (right arm) and
L (left arm) electrodes of I lead or R (right arm) and F (left leg) electrode of II lead.

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Note

⚫ For optimal respiration wave, R and L electrodes should be placed horizontally if I lead is
selected for respiration measurement; R and F electrodes should be placed diagonally if II
lead is selected for respiration measurement.

Fig. 8-1 below shows the placement of 5-lead electrodes

Fig. 8-1 5-lead Respiration Electrode Placement

8.3.1 Adjusting Position of Respiration Electrode

If you want to measure ECG and respiration simultaneously, you may need to adjust the
position of the two electrodes for respiration measurement. Adjusting the standard position of
ECG electrodes will lead to changes in the ECG wave, and may affect the ST and arrhythmia
analysis.

8.3.2 Cardiomotility Superimposing

The effect of cardiomotility on the respiratory wave is called cardiomotility superimposing.

When the respiration electrodes collect impedance changes caused by rhythmic blood flow,
this will happen. Placing the respiration electrodes correctly will reduce this effect. The liver
and ventricle should avoid the connection of respiration electrode, so that the heart or pulsating
flow won’t generate artifact.

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8.4 Resp Display

Resp wave is as shown in Fig. 8-2:

Fig. 8-2 Resp Wave

Resp parameters are displayed as shown in Fig. 8-3:

Fig. 8-3 Resp Parameter Area

8.5 Resp Setup

Click the ECG parameter zone or ECG wave area → [RESP Setup] menu, which is shown
below. You can set Resp through [RESP Setup] menu.

Fig. 8-4 [RESP Setup] Menu

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8.5.1 Setting Apnea Time

Apnea alarm is a high level alarm for monitoring the apnea. In [RESP Setup] menu, set [Apnea
Delay] to an appropriate value and set the apnea alarm time. When the apnea time of the patient
is longer than the set time, the monitor will trigger an alarm. Default apnea alarm time is 20s.

8.5.2 Adjusting Wave Gain

In [RESP Setup] menu, select [Gain], and set the wave gain: the greater gain, the higher wave
amplitude.

8.5.3 Setting Scanning Speed

In [RESP Setup] menu, select [Wave speed], and set the scanning speed: the faster scanning
speed, the smoother wave.

8.6 Alarm Setup

Select [Alarm Setup >>] to enter the [Alarm Setup] interface, and set the RESP alarm; see 6.5
Alarm Setup for the setting method.

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Chapter 9. PR

9.1 Overview

The mechanical activity of the heart causes arterial pulsation, and PR (pulse rate) value can be
obtained by measuring this pulsation. PR value can be obtained through SpO2 measurement.

9.2 Display

The color of PR parameter area is same as SpO2 parameter color of PR source, as shown in
Fig. 9-1:

Fig. 9-1 PR Parameter Area

9.3 Setting PR Sound

Select SpO2 parameter area or Pleth wave area → [SpO2 Setup] menu;

Select [Pulse Vol.] to set [Pulse Vol.] to 0~9, and plus / minus 1 each time the shuttle is turned.
Select 0 to turn off the key-pressing tone, and select 9 to set the maximum volume.

Note

⚫ HR sound has higher priority than PR sound; when HR makes a sound, PR won’t; when HR sound is 0, PR
can make a sound.

9.4 Alarm Setup

Select PR parameter area → [SpO2 Setup] menu → [Alarm Setup >>] to enter the [Alarm
Setup] interface, and set PR alarm switch, alarm level and upper/lower alarm limit. See 6.5

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Alarm Setup for detailed setting method.

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Chapter 10. SpO2

10.1 Overview

Blood oxygen saturation (SpO2) is the percentage of oxyhemoglobin (HbO2) capacity bound
by oxygen in the blood in the total hemoglobin (Hb) capacity that can be combined, that is,
the concentration of oxygen in the blood.

The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.

The principle for monitoring the pulse SpO2 is to fix the probe fingerstall on the patient’s finger,
use the finger as a transparent container for hemoglobin, use 660nm wavelength red light and
880nm near-infrared light as the incident light, maximum output power is 300 mw, measure
the light transmission intensity through the tissue bed, and calculate the concentration of
hemoglobin and SpO2.

The passing lights depend on a variety of factors, most of which are constant. However, one of
these factors, the arterial blood flow, changes with time, as it is pulsating. By measuring the
light absorbed during pulsating, it is possible to obtain the arterial blood SpO2. Detection
pulsation can give a “plethysmography” wave and pulse rate signal.

The main screen displays “SPO2” value and “plethysmography” wave.

This monitor applies to measure SPO2 of adults (>18 years), pediatric (30 Days to18 years).
Contact SPO2 probe to Patient’s finger to get “SPO2” value and “plethysmography” wave

SPO2 function of this monitor has been calibrated in factory.

10.2 Safety Information

Warning

⚫ Please use SpO2 sensor specified in this Manual, operate in accordance with the Manual, and
observe all warnings and precautions.

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⚫ Before monitoring, check whether the sensor cable is normal. When SPO2 sensor cable is
unplugged from the socket, the screen will display [SPO2Sensor OFF] error message, and
trigger an audible and visual alarm simultaneously.

⚫ If the sensor or sensor packaging has signs of damage, do not use this SPO2 sensor; return it
to the manufacturer.
⚫ If there is carboxyhemoglobin, methemoglobin or dye diluted chemical, the SPO2 value will
have deviation.

⚫ When the patient has a tendency to hypoxia, use the oximeter to analyze blood samples in
order to fully grasp the patient's condition.

⚫ Do not put the sensor on limbs with arterial duct or intravenous tube.

⚫ Do not intertwine electrosurgical equipment cable with the sensor cable.

⚫ Avoid using the monitor and sensors while using the NMR equipment, in order to avoid
severe burns to the patient as a result of induced currents.

⚫ During long time continuous monitoring of a patient, check the position of SpO2 sensor once
every 2 hours, and move properly when the skin changes or every four hours. Some patients
may require more frequent inspection, such as patients with perfusion disorders or sensitive
skin, because persistent and prolonged monitoring may increase unpredictable skin changes,
such as allergies, redness, blistering or pressure necrosis.

⚫ Carefully select SpO2 alarm upper limit. High oxygen level will cause crystal-like fibrous
tissue disease to premature children.

Note

⚫ Do not put the oxygen probe and blood pressure cuff on the same limb, because blood flow
occlusion during blood pressure measurement will affect the SpO2 readings.

⚫ This monitor cannot be used to verify the accuracy of SPO2 Probe and SPO2 machine.

10.3 Monitoring Steps

1. Select the appropriate SpO2 sensor according to the patient.

2. Turn on the monitor, and connect the SpO2 lead wire to the monitor.
3. Clean the measurement site, such as finger with nail polish.
4. Put the SpO2 sensor probe on the patient’s body.
5. Select the appropriate alarm settings.
6. Start monitoring.

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Note

⚫ Turn on the monitor, plug in SPO2 probe and connect patient’s finger, monitor displays
SPO2 wave,【SPO2 Pulse Search】 displayed in the technical alarm area until the monitor
measured SPO2 value and pulse rate. 【SPO2 Search Timeout】displayed in the technical
alarm area until the monitor measured pulse rate. Check the sensor mounting position,
whether the sensor is damaged or sensor type. Reconnect the sensor or use new sensor.

10.4 Display

SpO2 parameter area is shown in Fig. 10-1.

Fig. 10-1 SpO2 Parameter Area

Masimo SpO2 parameter area is shown in Fig. 10-2.

Fig. 10-2 Masimo SpO2 Parameter

1. SpO2 unit
2. Spo2 alarm range
3. SpO2 value
4. PR alarm range
5. PR value
6. PI value
7. PI indicator

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8. Source of PR

SpO2 wave is shown in Fig. 10-3.

Fig. 10-3 SpO2 Wave

Parameters Description

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.

10.5 Setting SpO2

Select SpO2 parameter area or Pleth wave area → [SpO2 Setup] menu, which is shown below.
You can set SpO2 through [SpO2 Setup] menu.

Fig. 10-3 [SpO2 Setup] Menu

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10.5.1 Setting Wave Speed

◼ Select [Wave Speed] and set wave speed to [12.5mm/s] or [25mm/s]; the faster speed, the
smoother wave.

10.5.2 Setting Wave Mode

◼ Select [Wave Mode], and set the wave drawing mode

◆ [Scan]: Scan mode.
◆ [Fill]: Fill mode.

10.5.3 Setting Average Time

SpO2 values displayed on the monitor are the results averaged from the data collected over
time. The shorter the average time, the faster the monitor responds when the patient's SpO2
value changes, but the measurement accuracy is lower. Conversely, the longer the average time,
the slower the monitor responds when the patient's SpO2 value changes, but the measurement
accuracy is higher. In monitoring critically ill patients, a smaller average time is conducive to
timely analysis of the disease.

The setting method follows:

◼ Select [Avg.Time] to set the average time to [2s], [3s], [4s], [5s], [6s], [7s] or [8s].

◼ For Masimo SpO2 module, select [Avg.Time] in the [SpO2 Setup] menu and then toggle
between [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] and [16 s].

10.5.4 Setting SpO2 Sensitivity

For Masimo SpO2 module, you can set [Sensitivity] to [Normal] or [Max] in the [SpO2
Setup] menu. When the [Sensitivity] is set to [Max], the patient monitor is more sensitive to
minor signals. When monitoring critically ill patients whose pulsations are very weak, it is
strongly recommended that the sensitivity is set to [Max]. When the patient tends to be in
motion, noise or invalid signals may be caused. In this case, it is recommended that the
sensitivity is set to [Normal] so that the interference caused by motion can be filtered and
therefore the measurement stability can be ensured.

10.6 Measuring Influencing Factors

During operation, the following factors can affect the accuracy of SpO2 measurement:

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◼ High-frequency radio wave interference, such as interference generated by the host

system or interference from electrosurgery instrument connected to the system.
◼ Intravenous dye.
◼ Too frequent movement of the patient.
◼ External light radiation.
◼ Sensor is improperly installed or improperly in contact with the patient.
◼ Sensor temperature (optimum temperature 28°C~42°C).
◼ The sensor is placed on limbs with blood pressure cuff, arterial duct or lumen tube.
◼ Concentration of non-functional hemoglobin such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb).
◼ SpO2 too low.
◼ Poor perfusion of test site.
◼ Shock, anemia, hypothermia, and the application of vasoconstrictor drugs may reduce the
arterial blood flow to a level that cannot be measured.
◼ The measurement also depends on the absorption of specific wavelengths of light by
oxyhemoglobin and reduced hemoglobin. If there is any other substance that absorbs the
same wavelength, the measurement may have false or low SPO2 values, such as: carbon
hemoglobin, methemoglobin, methylene blue, and indigo carmine.
◼ SPO2 probe described in Annex is recommended.
◼ Operating environment limit: Operating temperature range: 5～40℃, Humidity range:
0~80% (non-condensing), Elevation range: -500m~5000m.

10.7 Alarm Setup

In [SpO2 Setup] menu, select [Alarm Setup >>] to enter [Alarm Setup] interface, and set
SPO2 alarm switch, alarm level, upper and lower alarm limit. See 6.5 Alarm Setup for
detailed setting method.

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10.8 Masimo Information

◼ Masimo Patents
Masimo Patent： 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.

◼ Masimo Spo2 product description

The Masimo module is intended to monitor the PR, SpO2, PI of patients.

Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial
oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually
on the fingertip for adults, and the hand or foot for neonates. The sensor is connected to the
pulse oximetry instrument with a patient cable. The sensor collects signal data from the patient
and sends it to the instrument. The instrument displays the calculated data in three way

1. As a percent value for arterial oxygen saturation (SpO2)

2. As a pulse rate (PR)
3. As a plethysmographic waveform

◼ Masimo Spo2 Operating principals

Pulse oximetry is governed by the following principles

1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ

in their absorption of red and infrared light (spectrophotometry).

2. The amount of arterial blood in tissue changes with your pulse (photoplethysography).
Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as
well.

Pulse Oximeter uses a two-wavelength pulsatile system to distinguish between oxygenated and
deoxygenated blood. Signal data is obtained by passing red(rd)(660 nm wavelength) and infrared
(ir)(905 nm wavelength) light through a vascular bed (for example a fingertip, a hand, a foot) and
measuring changes in light absorption during the pulsatile cycle. This information may be useful to
clinicians. The radiant power of the light is rated at 0.79mW (max.). See figure below. utilizes a
sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a

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photodiode (photodetector).The photodetector receives the light, converts it into an electronic signal
and sends it for calculate.

Once receives the signal from the sensor, it utilizes Masimo SET signal extraction technology
for calculation of the patient’s functional oxygen saturation and pulse rate.

Warning

⚫ As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
⚫ Do not place the pulse oximeter or accessories in any position that might cause it to fall on
the patient.
⚫ Do not start or operate the pulse oximeter unless the setup was verified to be correct.
⚫ Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI
environment.
⚫ Do not use the pulse oximeter if it appears or is suspected to be damaged.
⚫ Explosion hazard: Do not use the pulse oximeter in the presence of flammable anesthetics or
other flammable substance in combination with air, oxygen-enriched environments, or
nitrous oxide.
⚫ To ensure safety, avoid stacking multiple devices or placing anything on the device during
operation.
⚫ To protect against injury, follow the directions below:
➢ Avoid placing the device on surfaces with visible liquid spills.
➢ Do not soak or immerse the device in liquids.
➢ Do not attempt to sterilize the device.
➢ Use cleaning solutions only as instructed in this operator's manual.
➢ Do not attempt to clean the device while monitoring a patient.
⚫ To protect from electric shock, always remove the sensor and completely disconnect the
pulse oximeter before bathing the patient.
⚫ If any measurement seems questionable, first check the patient’s vital signs by alternate
means and then check the pulse oximeter for proper functioning.
⚫ Inaccurate SpO2 readings may be caused by:
➢ Improper sensor application and placement
➢ Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
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➢ Elevated levels of bilirubin

➢ Elevated levels of dyshemoglobin
➢ Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
➢ Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle
cell, etc.
➢ Hypocapnic or hypercapnic conditions
➢ Severe anemia
➢ Very low arterial perfusion
➢ Extreme motion artifact
➢ Abnormal venous pulsation or venous constriction
➢ Severe vasoconstriction or hypothermia
➢ Arterial catheters and intra-aortic balloon
➢ Intravascular dyes, such as indocyanine green or methylene blue
➢ Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
➢ Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal
fingers. etc.
➢ Skin color disorders
⚫ Interfering Substances: Dyes or any substance containing dyes that change usual blood
pigmentation may cause erroneous readings.
⚫ The pulse oximeter should not be used as the sole basis for medical decisions. It must be used
in conjunction with clinical signs and symptoms.
⚫ The pulse oximeter is not an apnea monitor.
⚫ The pulse oximeter may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
⚫ The pulse oximeter may be used during electrocautery, but this may affect the accuracy or
availability of the parameters and measurements.
⚫ The pulse oximeter should not be used for arrhythmia analysis.
⚫ SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
⚫ Do not adjust, repair, open, disassemble, or modify the pulse oximeter or accessories. Injury
to personnel or equipment damage could occur. Return the pulse oximeter for servicing if
necessary.

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CAUTION:
⚫ Do not place the pulse oximeter where the controls can be changed by the patient.
⚫ Electrical shock and flammability hazard: Before cleaning, always turn off the device and
disconnect from any power source.
⚫ When patients are undergoing photodynamic therapy they may be sensitive to light sources.
Pulse oximetry may be used only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.
⚫ Do not place the pulse oximeter on electrical equipment that may affect the device,
preventing it from working properly.
⚫ If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the
patient’s condition.
⚫ If the Low Perfusion message is frequently displayed, find a better perfused monitoring site.
In the interim, assess the patient and, if indicated, verify oxygenation status through other
means.
⚫ Change the application site or replace the sensor and/or patient cable when a “Replace
sensor” and/or “Replace patient cable”, or a persistent poor signal quality message (such as
“Low SIQ”) is displayed on the host monitor. These messages may indicate that patient
monitoring time is exhausted on the patient cable or sensor.
⚫ If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field.
If the sensor is exposed to the radiation, the reading might be inaccurate or the device might
read zero for the duration of the active irradiation period.
⚫ To ensure that alarm limits are appropriate for the patient being monitored, check the limits
each time the pulse oximeter is used.
⚫ Variation in measurements may be profound and may be affected by sampling technique as
well as the patient's physiological conditions. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated and/or supplemented with additional test data.
Blood samples should be analyzed by laboratory instruments prior to clinical decision
making to completely understand the patient’s condition.
⚫ Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the pulse oximeter.
⚫ Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-
applied circuits and the system are within acceptable limits as specified by the applicable
safety standards. The summation of leakage currents must be checked and in compliance
with IEC 60601-1 and UL60601-1. The system leakage current must be checked when
connecting external equipment to the system. When an event such as a component drop of
approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before
further use. Injury to personnel could occur.

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⚫ Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
⚫ To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse oximeter.
⚫ Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently
displayed while monitoring consecutive patients after completing troubleshooting steps listed
in this manual.

Notes

⚫ A functional tester cannot be used to assess the accuracy of the pulse oximeter.
⚫ High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not
allow the pulse oximeter to obtain vital sign readings.
⚫ When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may
be compromised. If the device is in this setting and the sensor becomes dislodged from the
patient, the potential for false readings may occur due to environmental "noise" such as light,
vibration, and excessive air movement.
⚫ Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage
the patient cabling.
⚫ Additional information specific to the Masimo sensors compatible with the pulse oximeter,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).
⚫ Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate
readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for
the specified duration of the patient monitoring time.

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Chapter 11. NIBP

11.1 Overview

The monitor uses oscillometric method to measure noninvasive blood pressure (NIBP), and
applies to adults, pediatric.

The oscillometric method for measuring blood pressure is to inflate a cuff with a certain amount
of pressure until the arterial blood flow has been completely blocked. As pressure decreases,
the arterial blood flow will be completely occluded, gradually opened, and completely opened.
Then, the pulsation of the arterial vascular wall will generate a shock wave in the cuff. SBP,
MBP, and DBP are obtained by measuring and analyzing cuff pressure oscillations when
deflating.

◼ Produce first most clear signal - reflect SBP

◼ Oscillation amplitude reaches the peak - reflect MAP

◼ When the cuff pressure is suddenly lowered - reflect DBP

Measuring mode: manual, cycle, and continuous. Each mode shows systolic, mean and
diastolic blood pressure.

◼ Manual mode

Using Manual mode start to measures by hand

◼ Automatic mode measures

Use manual mode to open automatic mode, then the measure will automatically turn to
automatic mode after a certain time. During measurement. Any error will stop the current
automatic measurement, but not affect next automatic measurement unless the time interval
less than 30s. If the time interval less than 30s, should delay the next automatic measurement,
keep the interval more than 30s.

The time interval can be chosen in automatic mode as follow: 1, 2, 3, 4, 5, 10, 15, 30, 60, 90,
120, 180, 240, 480 minutes

◼ Continuous mode

Choose continuous mode, 5 seconds after complete a measurement start the next measurement,

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continue 5 minutes then stop. During measurement. Any error will stop the continuous
measurement. If the first measurement time is over 4 minutes and 40 seconds but less than 5
minutes, the continuous mode will stop before 5 minutes, if the first measurement time is over
5 minutes, the continuous mode will stop after 5 minutes

11.2 Safety Information

Warning
⚫ Do not carry out non-invasive blood pressure measurement on patients with sickle cell disease and skin
damage or any expected damage.
⚫ For patients with severe coagulation disorder, determine if the automatic blood pressure measurement is
carried out according to the clinical evaluation, since the friction of body and cuff may produce hematoma.
⚫ When measuring a child patient, ensure that the correct patient category (see Patient Info menu setting) is
selected in order to ensure that maximum cuff pressure does not exceed the measuring range of the patient
(pediatric mode: 240mmHg,Neonatal Mode：150mmHg). Using the wrong patient mode may endanger the
safety of patients because higher adult blood pressure level does not apply to children.
⚫ Do not install a cuff on the limbs with intravenous infusion or duct, because it may lead to tissue damage
around the duct when the cuff is inflated and makes the infusion slow down or be blocked.
⚫ The inflatable tube connecting the blood pressure cuff and the monitor should be smooth without
entanglement.
⚫ For patients with severe thrombotic disorders, determine whether to carry out automatic blood pressure
measurement according to the clinical situations, since the limb bundled with a cuff may produce hematoma.
⚫ Measure blood pressure frequently will affect the distribution of blood flow, May endanger the safety of
patients.
⚫ Check the patient's physiological condition before measure blood pressure, in order to ensure that long time
measure will not damage the circulation of patients
⚫ Mastectomy patients, using NIBP cuff to measure blood pressure on the surgery side arm.

11.3 Measurement Limits

According to the patient's condition, the oscillometric method has some limitations. This
measurement is to look for the regular pulse waves generated by arterial pressure. If the
patient's condition makes this detection method difficult, the measured value becomes
unreliable, and pressure measurement time increases. The user should be aware that the
following conditions may interfere with measurement method, making the pressure
measurement unreliable or extend the time. In this case, the patient's condition does not allow
measurement.

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◼ Patient movement

If the patient is moving, shaking or cramping, the measurement will be unreliable or even
impossible, as these may interfere with the detection of arterial pressure pulse, and extend the
pressure measurement time.

◼ Arrhythmia

If the patient shows arrhythmia which results in irregular heartbeat, the measurement will be
unreliable and even cannot be done, and the pressure measurement time will be extended.

◼ Use of an artificial heart-lung machine

If a patient is connected to an artificial heart-lung machine, the measurement will be impossible.

◼ Pressure changes

If the arterial pressure pulse is being analyzed to obtain a measured value at a certain time and
the blood pressure of the patient changes rapidly, the measurement will be unreliable or
impossible.

◼ Severe shock

If the patient is in severe shock or hypothermia, the pressure measurement will not be reliable,
because the decrease of blood flow to the periphery would cause decrease in arterial pulsation.

◼ Limit heart rate

If the heart rate is below 40bpm (beats / min) or above 240bpm (beats / min), the blood pressure
measurement is impossible.

◼ Obese patients

A thick layer of fat around a limb blocks the arterial oscillation so that it cannot reach the cuff.
The accuracy is lower than normal.

◼ Environmental Requirements

Measure blood pressure should meet the environment range as follow: ambient humidity
15%～80%, no condensing, ambient temperature 0～45℃, altitude -500m~5000m. NIBP
performance and measurement accuracy will be affected beyond the range.

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11.4 Measurement Procedure

11.4.1 Preparing for Measurement

1. Turn on the monitor, and check if it works properly;

2. Verify the patient category, and make changes if improper;
3. Connect the blood pressure cuff extension tube to the monitor;
4. Select the cuff in accordance with the following method, make sure that the cuff is
completely deflated, and then tie it to the upper arm or thigh of the patient.
◆ Determine the limb circumference of the patient.
◆ Select the appropriate cuff (marked with appropriate limb circumference). Cuff
width should be 40% of the limb circumference or 2/3 of the upper arm length. The
length of the inflated part of the cuff should be sufficient for 50%~80% around the
limb.
◆ Place the cuff on the upper arm or thigh of the patient, and ensure that the marking
φ is located just above the appropriate artery. Make sure that the cuff does not wrap
too tight around the limb, or it may cause distal discoloration or even ischemia.

11.4.2 Patient posture requirements during measurement

1. Sit comfortable or lie down relax;

2. No crossing legs
3. Back and elbow should be supported;
4. The center of NIBP cuff and the right atrium are at in the same level.
5. Remind patients, no talking during measurement and try to relax.

Note
⚫ If there is any question of measurement value, please repeat measurement then get average value, if the
average value is not correct, please change to mechanical blood pressure measurement equipment.

11.4.3 Starting / Stopping Measurement

Use the buttons on the monitor panel or [NIBP] smart hotkey on the display to start
/ stop the blood pressure measurement.

11.4.4 Correcting Measurement Results

The position of limb blood pressure measurement should be in the same horizontal position of
the patient's heart. Otherwise, correct the measurement results with the following correction
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method:

◼ If the cuff is above the heart level position, increase 0.75mmHg (0.10kPa) per centimeter
of gap to the measured results.
◼ If the cuff is below the heart level position, subtract 0.75mmHg (0.10kPa) per centimeter
of gap from the measured results.
◼ If the patient is obese or clothes are too thick, subtract 5mmHg ~ 10mmHg (0.65kPa ~
1.3kPa) from the measured results.

11.5 NIBP Display

NIBP measurement has no waveform display, and only displays NIBP measurement results in
the parameter area, as shown in Fig. 11-1. The figure below is for reference only. The graphics
displayed on the monitor may be slightly different.

Fig. 11-1 NIBP Parameter Area

11.6 Setting Inflation Pressure

If necessary, you can manually set the initial cuff inflation pressure as follows:

◼ Select the NIBP parameter area → [NIBP Setup] menu;

◼ Select [Pre-Infl Press], and set the appropriate cuff pressure value.

11.7 NIBP Resetting

Select NIBP parameter area → [NIBP Setup] menu → Select [Reset], and restore the inflation
pressure of the blood pressure pump to currently configured initial settings. When the blood

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pressure pump is not working properly, but no warning is given, you can reset the blood
pressure pump, and automatically restores the blood pressure pump.

11.8 NIBP Leakage Test

The purpose of leakage test is to detect if the sealing of the air passage is in good condition. If
the leakage test passes, the NIBP parameter area displays [Leakage test Stopped]. If not passed,
the NIBP parameter area displays [Cuff leak] message. NIBP leakage test shall be at least once
every two years or when you think that the reading is not accurate.

Prepare the following materials before the test:

◼ Adult cuff: one

◼ Inflation tube: one
◼ Cylinder of appropriate size: one

Leakage test process

1. Connect the cuff to the NIBP pore of the monitor

2. Wrap the cuff on the cylinder of appropriate size.
3. Set the patient category to adults.

4. Select [Menu] Smart Hotkey → [Main Menu];

5. Select [User Maintenance >>]→ [User Maintenance] menu;

6. Select [Module Maintenance >>] → [Module Maintenance] menu;
7. Select [NIBP >>] → [NIBP Maintenance] menu, and select [Leak Test] for leakage test.
8. After 20s, the system will automatically open the bleeder valve, and the leak test finishes.
9. If the NIBP parameter area displays [Leakage test Stopped], the system does not leak. If it
displays [Cuff leak], it indicates that the air passage leaks. At this time, the operator should
check if the entire connection is loose, and test for leak once again when the connection is
correct. If there is error prompt still, please contact the manufacturer for repair.

Fig. 11-2 NIBP Leakage Test Connection Diagram

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11.9 NIBP Calibration

Users can not calibrate NIBP. If calibration is required, please contact your service
representative. Cuff pressure sensor should be checked and calibrated at least once every two
years by qualified professional service personnel.

11.10 Clean and disinfection method of NIBP cuff

If necessary, NIBP cuff and NIBP extension tube can be cleaned and disinfected together
without separated

11.10.1 Cleaning Method:

1. Prepare enzyme cleaning agent, distilled water and 10% solvent, respectively in different
spray bottle.
2. Sprinkle cleaning agent on NIBP cuff, connector and extension tube, keep 1 minutes for
the dry stains.
3. Use a soft cloth to wipe smooth face. Use soft hair brush to brush visible stain and
irregular surface

Note

⚫ Please be especially careful to clean the air ball and control valve of whole air system. Do not
allow any liquid entering into reversing valve and saturated valve
⚫ Don’t use a soft cotton ball and fiber to clean this accessory, because they will stick on the
cuff and extension tube.

11.10.2 Disinfection Method

1. Sprinkle bleach solution (Formula: the proportion of water and bleaching powder to 1:10)
then keep 5 minutes
2. Wipe off excess bleach solution and elute with distilled water again
3. Natural dry cuff

11.11 Alarm Setup

In [NIBP Setup] menu, select [Alarm Setup >>] to enter [Alarm Setup] interface, and set NIBP
alarm switch, alarm level, upper and lower alarm limit. See 6.5 Alarm Setup for detailed setting
method.
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Chapter 12. Temp

12.1 Overview

This monitor has two temperature measurement channels; the temperature sensor will measure
the body temperature, and calculate the difference between the body temperature data.

12.2 Safety Information

Warning
⚫ Before monitoring, check if the probe cable is normal. Unplug the temperature probe cable from the jack, the
screen will display [TEMP1/TEMP2 Sensor Off] prompt and make an alarm sound.
⚫ Calibrate the temperature measuring instrument at least once every two years (or according to hospital
procedures). When calibration is required, please contact the manufacturer.

12.3 Measurement Steps

Please refer to the following steps:

1. Turn on the monitor and check if it works normally.

2. Select the appropriate temperature probe according to the patient category and
measurement needs.
3. Insert the probe lead wire into the temperature probe interface.
4. Attach the probe to the patient properly.
5. Make sure that the alarm settings apply to the patient.

12.4 Measuring Requirements

The normal measuring range of body temperature is 5~50°C, and the accuracy is consistent in
this range.

The environmental temperature range for body temperature measuring is 0~55°C, the
minimum measuring time is 1s, and the measuring interval is 1s.

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Warning
⚫ Please measure the body temperature in the specified environmental temperature range, or else it may be
dangerous.

12.5 Temp Display

The monitor can display the body temperature of two channels (T1 and T2) and the alarm limits,
difference between the two temperature (TD) and temperature units. Select Temp parameter
area and open the [Temp Setup] menu.

Temp display area is shown below:

Fig. 12-1 TEMP Parameter Area

12.6 Selecting Resistance Type of Temp Probe

Select the appropriate [Temp Sensor] value according to the actual resistance of the
temperature probe being used. The specific setting method follows:

◼ Select [Menu] smart hotkey → [Main Menu];

◼ Select [Factory Maintenance] → Enter and confirm the password → [Factory

Maintenance] menu;
◼ In [Factory Maintenance] menu, set [Temp Sensor] to

◆ [10K], probe resistance is 10kΩ;

◆ [2K], probe resistance is 2.25kΩ.

Warning
⚫ If the temperature value displayed by the monitor has significant difference from the body
temperature under normal condition, please check if the probe resistance of the monitor
matches the resistance set in the monitor system; if not, please replace a probe with
appropriate resistance or adjust the monitor and select the appropriate resistance.
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12.7 Setting Temperature Unit

You can define your favorite temperature unit as follows:

◼ Select TEMP parameter area → [TEMP Setup] menu;
◼ In the [TEMP Setup] menu, set [Unit] to [°C] or [°F].

12.8 Alarm Setup

In [TEMP Setup] menu, select [Alarm Setup >>] to enter [Alarm Setup] interface, and set
TEMP alarm switch, alarm level, upper and lower alarm limit. See 6.5 Alarm Setup for detailed
setting method.

12.9 Quick Temp(Optional)

12.9.1 Quick Temperature Display

Select 【Switch】Enter【Screen Setup】menu, go to【Main】page and select【QTT】from

main screen, as shown below Fig. 12-2.

Fig. 13-2 Screen Setup Menu

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QTT parameter will display in the main screen, when there is no measurement, the numeric area
will show 【 -?- 】 ， after measurement by using ear thermometer, this area will display
measurement result same as ear thermometer shows. As shown below Fig. 12-3.

Fig. 12-3 QTT Parameter Area

Select QTT parameter area to enter【QTT Setup】menu for unit setup and alarm setup, as shown
below Fig.12-4.

Fig. 12-4 QTT Setup

12.9.2. Accessories list

Cover cap x 1 pc, probe cover x 1 pack, pressure disk x 1 pc, battery x 1 pc(inside of ear
thermometer). As shown below Fig. 12-5

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Fig. 12-5 Infrared Ear Thermometer list

Notice ： When clean the device with alcohol, please wait till alcohol complete dry before
measurement.

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Chapter 13. Review

The monitor provides up to 120 hours trend data review of all monitoring parameters, 1000
groups of NIBP measurement data and 200 alarm events. The user can select trend chart or
trend table to view trend change; or view the latest wave.

13.1 Reviewing Trend Chart

Select [Review] smart hotkey to enter [Review] menu, and select [Graphic] to enter the
following window.

Fig. 13-1 Trend Chart

◼ In the trend chart, use the following method to select the parameter to be reviewed:
◆ Select the parameter box, rotate the shuttle to select the parameters to be reviewed,
click on the shuttle, and set the parameter box as the parameter to be reviewed.

◼ Select [Interval], and select the option as needed:

◆ [1s]: observe the trend of the last hour at 1sec interval.
◆ [5s]: observe the trend of the last eight hours at 5sec interval.

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◆ [1min]: observe the trend of the last 120 hour at 1min interval.
◆ [5min]: observe the trend of the last 120 hour at 5min interval.
◆ [10min]: observe the trend of the last 120 hour at 10min interval.
◆ [30min]: observe the trend of the last 120 hour at 30min interval.
◆ [60min]: observe the trend of the last 120 hour at 60min interval.

◼ Browse the trend chart in the following method:

◆ Select and to move the trend cursor.

◆ Select and to turn pages to left or right and move the trend chart.

◆ The cursor top displays the current time corresponding to the current cursor position,
and the left of the trend chart window displays the parameter values of the time,
which will change automatically with the move of trend cursor.

13.2 Reviewing Trend Table

Select [Review] smart hotkey to enter [Review] menu, select [Tabular] and enter the

following window.

Fig. 13-2 Trend Table

◼ Select [Interval], and select the option as needed:

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◆ [1s]: observe the data of the last hour at 1sec interval.

◆ [5s]: observe the data of the last eight hours at 5sec interval.
◆ [1min]: observe the data of the last 120 hour at 1min interval.
◆ [5min]: observe the data of the last 120 hour at 5min interval.
◆ [10min]: observe the data of the last 120 hour at 10min interval.
◆ [30min]: observe the data of the last 120 hour at 30min interval.
◆ [60min]: observe the data of the last 120 hour at 60min interval.

◼ Browse the trend table in the following method:

◆ Select and to turn pages to left or right and move the trend table to

observe the target parameters.

◆ Select and to move the trend table upward or downward progressively

and observe more data.

◆ Select and to turn pages up or down and move the trend table to observe

more data.

13.3 NIBP Measurement Review

Select [Review] smart hotkey to enter [Review] menu, and select [NIBP] to enter the
following window

Fig. 13-3 Measurement of NIBP Review

This window shows the measurement time of noninvasive blood pressure, systolic blood

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pressure [Sys], diastolic blood pressure [Dia], mean blood pressure [Mean] and pulse rate [PR]. The
monitor can store 1000 sets of NIBP measurements in total.

◼ NIBP viewing method is as follows:

◆ Select and to move the trend table upward or downward progressively

and observe more data.

◆ Select and to turn pages up or down and move the trend table to observe

more data.

13.4 Event Review

Select [Review] smart hotkey to enter [Review] menu, and select [Event] to enter the
following window.

13.4 Event Review

This window shows the time of alarm events and corresponding alarm information, and the
time of manual events and corresponding manual tag events. This monitor allows reviewing
200 events in total, including the physiological alarm events, technical alarm events and
manual events.

◼ Select [Module], and select an option as needed:

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◆ [ECG]: View ECG-related alarm events.

◆ [SPO2]: View SPO2 related alarm events.
◆ [NIBP]: View NIBP related alarm events.
◆ [RESP]: View RESP related alarm events.
◆ [TEMP]: View TEMP related alarm events.
◆ [Manual]: View manual events.
◆ [All]: View all related events.

◼ Select [Level], and select an option as needed:

◆ [High]: View high level alarm events.
◆ [Mid]: View middle level alarm events.
◆ [Low]: View low level alarm events and manual events.

◼ Select [Wave Forms] to view the waveform and relevant parameters when alarm occurs,
as shown in Fig. 13.5 below:

Fig. 13.5 Waveform Review

◼ Event viewing method is as follows:

◆ Select and to move the trend table upward or downward progressively

and observe more data.

◆ Select and to turn pages up or down and move the trend table to observe

more data.
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Chapter 14. CO2

14.1 Introduction

CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2
in the patient’ airway by measuring the absorption of infrared (IR) light of specific wavelengths.
The CO2 has its own absorption characteristic and the amount of light passing the gas probe depends
on the concentration of the measured CO2. When a specific band of IR light is passed through
respiratory gas samples, some of IR light will be absorbed by the CO2 molecules. The amount of
IR light transmitted after it has been passed through the respiratory .gas sample is measured with a
photodetector. From the amount of IR light measured, the concentration of CO2 is calculated

There are two kinds of CO2 measuring module:

1. Mainstream(IRMA) measurement uses a CO2 sensor attached to an airway adapter directly
inserted into the patient’s breathing system.
2. Sidestream/Microstream (ISA) measurement samples expired patient gas at a constant sample
flow from the patient’s airway and analyzes it with a CO2 sensor built into the CO2 module.

The measurement provides:

1. A CO2 waveform.
2. End tidal CO2 value (EtCO2): the CO2 value measured at the end of the expiration phase.
3. Fraction of inspired CO2 (FiCO2): the smallest CO2 value measured during inspiration.
4. Airway respiration rate (awRR): the number of breaths per minute, calculated from the CO2
waveform.

Fig. 14.1 CO2 Parameter and waveform

Warning
ISA and IRMA can only be operated by professionals having received career training and possessed a good
knowledge of the Manual.
Please specify the working temperature of environment to run ISA and IRMA module, ISA modules are not designed
for (MRI) environment, during the MRI scan, ISA module must be on the outside of MRI.
ISA and IRMA CO2 module only as an auxiliary equipment of patient evaluation, it must be use with other vital
signs and symptoms of evaluation equipment instrument.
ISA and IRMA module using in high frequency surgical equipment will be lead to the result of measure.
In using, don’t stretch the Probe cable of ISA and IRMA.

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14.2 Preparing to Measure CO2

14.2.1 Using a Sidestream CO2 Module

1. Connect the Interface cable of CO2 module to the monitor interface with CO2 mark.
2. Connect Nomoline sample line to the input interface of CO2 module.

Fig. 14-2 Sidestream CO2 Module and Nomoline

3. Exit of Gas sample Connect to drain-off system, or the gas flow loop back to the patients.
4. Start Monitor, green LED of input interface CO2 module can be normal work.
5. Access the [CO2 Setup] menu to set [Operating Mode] to [Measure]. After about 10S, the
module can be enter measure.

WARNING
⚫ Nomoline sample line can’t be reusing, and sample tube can be waste treatment after used according to the
regulations of the local medical rule.
⚫ Changed Nomoline sample tube every 2 weeks or it displayed “tube stoppaged” (Red sampling line).
⚫ Only can use MASIMO produced Nomoline sampling tube, otherwise it will lead to inaccurate
measurements.
⚫ Seriously rationalize sampling tube, to reduce the risk of twisting or bridle patients.
⚫ Please confirm whether the current sampling tube is suitable for the patient, don’t be confused baby and
adult/child tube when connection.
⚫ Check whether sample gas velocity in patients with given category is too high.
⚫ When put ISA CO2 module, should be firmly installed ISA module, avoid to put it in patients on the
location.
⚫ If the acquisition of gas samples for breathing air supply, use bacteria filter on the exhaust side all the time.

CAUTION:
⚫ Nomoline sampling tube connected to the front of breathing circuit, actions as follow:
⚫ Connect sampling tube to the CO2 gas module.
⚫ Check the port to green light (indicating system normal).

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⚫ Exhaling to the sampling tube, check monitor interface whether display effective carbon dioxide waveform
and parameter values.
⚫ Block sampling tube, wait for 10s, check whether display clogging alarm and air interface display red light.
⚫ After connect ISA module, View ISA interface indicator to Judge normal operation.
⚫ Under the right circumstances, checking the sampling tube was leakproofness of patients.
Chart14-1 ISA module index signal
Index signal condition
Green light no flicker System Normal
Green light flicker Zeroing
Blue light no flicker There is Anesthetic gases
Red light no flicker Sensor Error
Red light flicker Testing sampling tube

14.2.2 Using a Mainstream CO2 Module

1. Connect Interface cut cable of Mainstream CO2 module and monitor which mark CO2.
2. Install probe of the mainstream CO2 module to airway adapter, probe will get into place
after right installed.

⚫ Green LED light indicate IRMA Probe of Mainstream CO2 Module can be use normally.

⚫ Connect 15MM (M) of IRMA airway adapter to Y connector of breathing circuit.

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⚫ Connect 15MM (F) of Mainstream CO2 module airway adapter to internal tube of patient.

⚫ In the【CO2 Setup】menu, select【Operating Mode】and toggle【Measure】,after 10s,

Module enter into Measuring condition.

WARNING

⚫ Do not repeat use disposable IRMA airway adapter, or it will cause cross infection.
⚫ The used disposable airway adapter should be dealt with according to the regulations of local medical waste
⚫ Please confirm the current sampling tube is suitable for patient .do not confused baby and adult/child tube.
⚫ The CO2 module probe should always make status LED facing up, unless use HME mainstream CO2
protection module probe.
⚫ Avoid CO2 module probe in contact with baby’s body directly when CO2 mainstream module probe
connected to infant circuit.(no matter for any reason to make the CO2 sensor direct contact with any part of
baby’s body ,must be use insulating materials between CO2 and part of body).
⚫ Don’t put IRMA airway adapter between endotracheal tube and elbow, otherwise secreta of patient will jam
the airway adapter and operation mistake.
⚫ Replace adapter if airway adapter in water/water condensation
⚫ Only using made in Masimo IRMA airway adapter.

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CAUTION

⚫ Before CO2 airway adapter connecting to breathing circuit, Verify CO2 readings and waveform on the
monitor, after install CO2 sensor to airway adapter module, check patient’s seal.
After access module, check LED lights of IRMA Probe indication, to check if module is working normally.
Chart 14-2 Probe index signal
index signal condition
Green light no flicker System Normal
Green light flicker Zeroing
Red light no flicker Sensor Error
Red light flicker Testing sampling tube

14.3 CO2 Settings

Turn knob to move cursor to the area of CO2 parameters, Press button to enter setting【CO2
setup】menu.

Fig. 14-3 CO2 setup menu

【Apnea time】:The Monitor will alarm if the patient has stopped breathing for longer than the
preset apnea time. Can Setup for：20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s
【Operating Mode】: CO2 module can setup to “Measure” or “Standby”.
Measure：CO2 module can be normal measurement and zeroing etc.
On standby：CO2 module do not work, not accept CO2 measurement, zeroing, calibrating etc.
【O2 Compen】: Can setup for low, medium, high, default value is low.
【N2O Compen】:Can setup for ON, OFF, default value is off.
【Unit】:Use for EtCO2 and FICO2 parameter display, can setup units for mmHg, Kpa,%,
Default value is mmHg.
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【Waveform speed】:Use for adjust speed of CO2 waveform, can setup for
6.25mm/s,12.5mm/s,25mm/s
【Waveform type】
Draw：The CO2 wave is displayed as a curved line.
Fill：The CO2 wave is displayed as a filled area.
【Scale】Change the size of the CO2 waveform by adjusting the wave.

14.4 Measurement limitations

The following factors may influence the accuracy of measurement:

⚫ The quantitative influence of humidity or condensation.
⚫ The quantitative influence of atmospheric.
⚫ Gas or water steam of interference
⚫ Other sources of interference.

14.5 Zeroing the Sensor

In order to ensure the CO2 module measurement with high accuracy, should be zero according to
the following suggestions:

For Mainstream IRMA Modules：

⚫ New IRMA airway adapter installed on IRMA probe before Zeroing, Airway adapter
don’t need connected to patient circuit, wait for 10S makes probe preheating.
⚫ Open 【CO2 setup】Menu, Select【Zeroing】button, IRMA module starting zeroing.
During the process of zeroing, the green LED of the probe flashes for about 5s.

WARNING

⚫ Incorrectly zero of the probe will cause the false results of the gas degrees.
⚫ ISA sidestream module.
⚫ ISA side stream module is automatically zeroed by sampling the gas from the breathing
circuit to the ambient air. It performs automatic calibration every 24 hours. Each calibration
takes less than 10 seconds. User can also manually zero when necessary, select the [AA
Setup] menu, and press the [Zero] button.

Warning

⚫ While ISA module calibration, ensure that the ISA module in a well-ventilated place. Before
and during calibration, avoid breathing in the vicinity of ISA module.

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14.6 Notice

If the ISA module is installed with an oxygen sensor, then the automatic zero procedure includes
the oxygen sensor calibration of indoor air.
Calibration
All the required constants of IRMA mainstream modules are stored in each IRMA probe, so after
replacing the probe of IRMA, no calibration is required.
Before shipment, a permanent calibration is performed to the ISA sidestream, with a stable design,
no periodic calibration is required for the module.
A calibration to the CO2 sidestream can be performed once a year on the request of the user or
when the deviation is large. For more information, see the Maintenance section.

14.7 Cleaning

⚫ 1. Regularly clean the ISA sidestream or the AG module of the IRMA mainstream, a high
concentration of 70% ethanol or isopropanol with a damp cloth is recommended.
⚫ 2. To prevent the cleaning liquid and dust into the ISA sidestream module, the module needs
to be connected to the Nomoline sampling tube all the time while being cleaned.
⚫ 3. For the AG module of the IRMA mainstream, it is required to remove the disposable
IRMA airway adapter before cleaning the IRMA probe

Warning
⚫ IRMA mainstream CO2 module and Nomoline sampling tube is not sterile equipment, please Do Not
autoclave the device, otherwise it will cause damage.
⚫ Never disinfect the IRMA probe or the ISA sidestream module and do not put either of them into immersed
liquid.
⚫ Do not use the quantitative spray or spray equipment together with the sidestream module or the IRMA
airway adapter. Otherwise it may clog the bacteria filter
⚫ Do not apply a negative pressure to Nomoline(such as using a syringe) to remove the condensation

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Chapter 15. Recording (Optional)

15.1 Recorder Profile

The monitor adopt the thermal recorder, supports many recording Types, records patient
information, trend graph/table data, up to three waveforms, etc.

Fig. 15-1 Recorder

1. Indicator
◆ On: when the recorder works correctly.
◆ Off: when the monitor is switched off.
◆ Flashes: if an error occurred to the recorder, e.g., the recorder runs out of paper, jams, over
heat, etc.
2. Wrench: Gently pull out the wrench, the printer will automatically open the doors
3. Paper outlet
4. Recorder door
The task-related recordings include:
◆ Real time recording
◆ 7-Lead waveforms recording
◆ Alarm trigger recording
◆ Frozen wave recording
◆ Graphic trends recording
◆ Tabular trends recording
◆ NIBP review recording
◆ Event review recording

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15.2 Loading Paper

1. Pull out the wrench of the recorder, open the door.
2. Insert a new roll into the compartment with the recording side upward, make sure the paper end
in the outside of paper outlet port.
3. Close the door of the recorder.
4. Check the position of the paper, make sure the paper aligned to the Recorder outlet.

CAUTION
⚫ Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s printer
head, the recorder may be unable to print, or poor print quality may result.
⚫ Never pull the recorder paper with force when a recording is in process, otherwise, it may cause
damage to the recorder.
⚫ Do not leave the recorder door open unless you reload paper or remove troubles.
⚫ If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam first.
If a paper jam is detected, open the recorder door, take out the paper and tear off the draped
part, reload the paper and close the recorder door.

15.3 Setting up the Recorder

By selecting [Main Menu] → [Record Setup >>], you can access the [Record Setup] menu. As the
following figure:

Fig. 15-2 Recorder setup

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1. [Types]: normal type, 7-lead type can be setup.

◆ Normal type 【conventional】:The waveforms that you need to record can be setup in
wave options.
◆ 7-lead type【7lead】: Press record key, then 7-lead ECG can be record.
2. 【Trace】:The trace of waveforms can be set up, 3 traces or 2 traces. The wave type can be
choose from wave option.
3. 【 Recording time】:when start one real time record or alarm trigger, the record time is depend
on your setting on the monitor.in the menu【Record Setup】→[Record time >>] can be set:
◆ 8s/16s/32s: record 8-second waveforms from the current moment.
◆ [Continuous]: record the waveforms from the current moment until stopped manually.
◆ 【Recording Speed】: In the [Record Speed] menu, select [Paper Speed] and toggle
between [12.5 mm/s], [25 mm/s] and [50mm/s]. This setting is for all recordings
containing waveforms.

15.4 Clearing Recorder

If the recorder has been used for a long time, deposits of paper debris may collect on the printhead
compromising the print quality and shortening the lifetime of the roller. Follow this procedure to
clean the printhead:
1. Take measures against the static electricity such as Disposable Wrist Strap for the work,
Prevent electrostatic damage to the Recorder.
2. Open the recorder door and take out the paper, so as not to impede clean.
3. Gently wipe around the printhead using cotton swabs dampened with alcohol.
4. After the alcohol has completely been dried, reload the paper and close the recorder door.

CAUTION
⚫ Do not use anything that may destroy the thermal element, for example sandpaper.

⚫ Do not add unnecessary force to the thermal head.

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Chapter 16. Battery

16.1 Checking Battery Performance

Please refer to the following steps to check the battery performance:

1. Disconnect the monitor from the patient and stop all monitoring or measurement.
2. Connect AC power to the monitor, and charge the battery for 10 hours uninterruptedly.
3. Disconnect the AC power and power the monitor with battery until the monitor is turned
off.
4. Battery duration reflects the battery performance.
If the battery operating time is significantly shorter than the time stated in specifications,
consider replacing the battery or contact our service personnel.

16.2 Overview

The monitor has a built-in rechargeable battery to ensure that the monitor can also be used
normally in case of patient transfer or power failure. When the monitor is connected to an AC
power source, it will charge the battery no matter whether the monitor is turned on or not. In
the case of power failure, the system will automatically use the battery to power the monitor to
avoid interrupting the monitor working.

The battery icon on the screen indicates the battery status:

Battery is working properly and is fully charged.

Battery is working properly and the green part indicates the battery power.

Battery power is low, and requires charging immediately, or else the monitor will turn

off automatically.

Monitor battery is not installed.

Battery is properly installed and being charged.

The battery power can only maintain for some time. Low battery voltage will trigger a high
level technical alarm [Battery Low]; in this case, connect the monitor to AC power and charge
the battery.

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16.3 Installing the battery

Before replacing the battery, please connect the monitor to an AC power supply or turn it off,
to avoid monitoring being interrupted.

To install or replace the battery:

◼ Open the battery cover.
◼ Push aside the side battery stopper of the battery to be replaced and take out the
battery.
◼ Keep the front side of the new battery (with printed text) downwards, interface
toward the inside, insert it into the battery compartment, push back the battery
stopper, and hold down the battery.
◼ Put on the battery cover.

16.4 Battery Usage Guide

Battery life depends on the frequency and time of use. If the battery maintenance and storage
are proper, the lithium battery life is about three years. If you do not use the battery properly,
its life may be shortened. It is recommended to replace the lithium battery once every three
years.

In order to ensure the maximum capacity of the battery, please note the following usage guide:

◼ Before using the battery, please read the Operator’s Manual and labels on the
battery surface carefully.
◼ Do not drop the battery, and do not charge the battery in the charger for more than 24h.
◼ Before transporting the monitor or if the monitor won’t be used over three months, please
take out the battery.
◼ If it won’t be used for a long time, please store the battery properly. Charge the battery to
50%, and wrap the battery with non-conductive material in order to avoid direct contact
with metal, resulting in damage. Keep the battery in a cool dry place.
◼ Check the battery performance once every two years. Before servicing the monitor or you
suspect that the battery is the fault source, also check the battery performance.

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Warning

⚫ Keep the battery out of the reach of children.

⚫ Use only the designated battery.
⚫ If the battery is damaged or leaks, replace it immediately. Do not use a defective battery for the monitor.

16.5 Battery Recycling

If the battery has visible damage or cannot store power, it should be replaced and recycled
properly. Follow the appropriate regulations to dispose of used batteries.

Warning

⚫ Do not disassemble the battery, throw it in fire, or short-circuit it. Battery fire, explosion and leakage
may lead to personal injury; do not directly touch the leaking battery.

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Chapter 17. Cleaning and Disinfection

17.1 Cleaning and disinfection safety information

WARNING
● Before cleaning or disinfecting, disconnect the monitor from the power supply

● Never immerse any part of the device, cables, or leadwires in liquids or allow liquid to
enter the interior of the device.

● Do not pour or spray any liquid directly on cables or leadwires or permit fluid to seep into
connections or openings.

● Do not autoclave any part of the device with steam (including cables or leadwires) or
sterilize with ethylene oxide.

● Avoid use of cleaners, materials or chemicals that may damage device surfaces, labels, or
cause equipment failures.

CAUTION
● Do not use or store equipment outside the specified temperature, humidity, or altitude
ranges.

● To clean or disinfect reusable accessories, refer to the accessories' own instructions for use
for detailed information. Do not reuse single-use disposable accessories.

● If liquid has accidentally entered the device or its parts,disconnect the power cord from the
power supply and have the equipment serviced by authorized service personnel.

● Do not let liquid pool around connection pins. If this should happen, blot dry with a soft,
lint-free cloth.

● Use only manufacturer approved detergents and disinfectants and methods listed in this
chapter to clean or disinfect your equipment.

NOTE
● Do not spray cleaner directly on the LCD display screen.

● Never connect any device or applied part to a patient until it is thoroughly dry.

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17.2 Approved detergents and disinfectants

The table below lists the cleaning and disinfecting agents that can be used on the device and
accessories.

Name Type
Clean water Rinsing detergent
Soap water (pH value of 7.0~10.5) Rinsing detergent
Ethanol (75%) Moderately efficient disinfectant

Isopropanol (70%) Moderately efficient disinfectant

Highly efficient disinfectant

Hydrogen peroxide ( Hydrogen peroxide 3%)

Sodium hypochlorite bleach ( Sodium Highly efficient disinfectant

hypochlorite bleach 5%)

17.3Methods for Cleaning and Disinfection

Selecting the appropriate method to clean and disinfect the device and accessories based on the
actual situations to avoid cross-contamination risk, including use for the first time and use after
many times.

17.3.1 Preparation before cleaning

Thoroughly inspect the device and the accessories before cleaning.
(1) Turn off the power to the equipment.
(2) Disconnect the equipment from the power supply
(3) Look for any signs of damage and make sure that the keys and connectors work correctly.
(4) Gently bend and flex cables, inspecting them for damage or extreme wear,
exposed wires, and bent connectors.
(5) Confirm that all connectors engage securely.
(6) Remove all cables and batteries and close battery door(s).
17.3.2 Cleaning and disinfection non-applied parts
To clean and disinfect non-applied parts including the exterior surface , display screen surfaces,
the plugs housing ,the ports, the keys, movable handle ,battery cover and other non-applied parts.
The table below lists the cleaning and disinfection methods of non-applied parts.

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Recommended
Cleaning method Disinfection method
Parts frequency
Interval

the exterior surface , Each patient Wipe: wipe with a damp Wipe: wipe with a damp
cloth immersed in cloth immersed in
the plugs
alkalescent detergent medium- or high-
housing ,the keys, (soapy water, etc.) or efficiency disinfectant and
movable alcohol solution, and then then wipe off the
wipe off the remaining remaining disinfectant
handle ,battery
detergent with a dry lint- with a dry lint free cloth.
cover and other free cloth. Dry: dry thoroughly with
non-applied parts. NOTE:Any contact of a dry, lint-free cloth and
detergents with metal parts let air dry for at least 30
may cause corrosion.Do not minutes.Drying times may
damage or bend connector vary based on the
pins when cleaning. environmental conditions.
Do not let fluid pool around NOTE:Any contact of
connection pins. If this disinfectant solutions with
happens, blot dry with a metal parts may cause
cotton swab or soft cloth. corrosion.
Do not damage or bend
connector pins when
disinfection or drying.
Do not let fluid pool
around connection pins. If
this happens, blot dry with
a cotton swab or soft
cloth.
Display screen Each patient Wipe: wipe with a damp N/A
cloth immersed in water or
surfaces Disinfectants can damage
soapy water, and then wipe
off the remaining detergent the display screen.
with a dry lint-free cloth.
Dry: dry thoroughly with a
dry, lint-free cloth and let
air dry for at least 30
minutes.Drying times may
vary based on the
environmental conditions.
Note :Do not spray
detergent directly on the
display screen.

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17.3.2 Cleaning and disinfection applied parts

To clean and disinfect applied parts including ECG Cables,SPO2 Probe and cable, TEMP Probe
and cable, CO2 Module , Reusable NIBP Cuff, NIBP Cuff tube,NIBP Cuff Connector etc.
For the applied parts, refer to the accessories' own instructions for use for detailed information.
According to manufacturer instructions for recommended cleaning methods and products.

General method to clean and disinfect applied parts :

(1) For general cleaning of cables and leadwires, wipe using a lightly moistened cloth with a mild
soap and water solution.
(2) For disinfecting the cables and leadwires, wipe exterior with a soft lint-free cloth, using a
Ethanol or Isopropanol (70%). Refer to the cables' and leadwires' own instructions for use for
detailed information regarding allowed substances.
Note : Any contact of disinfectant solutions with metal parts may cause corrosion.

Do not immerse either end of a cable or leadwire connector. Immersing or soaking

the connector ends may corrode metal contact ends and affect signal quality.
(3) Wipe off cleaning solutions with a clean, lightly moistened cloth.
(4) Dry thoroughly with a dry, lint-free cloth and let air dry for at least 30 minutes.Drying times
may vary based on the environmental conditions. Do not apply heat.

PARTS Recommended Cleaning and disinfection method

frequency Interval
ECG Cables Each patient/weekly Refer to the cleaning and disinfection
methods provided by the manufacturer.
SPO2 Probe and cable Each patient/weekly Refer to the cleaning and disinfection
methods provided by the attached
package insert.
Reusable NIBP Cuff, Each patient/weekly Refer to the cleaning and disinfection
NIBP Cuff tube,NIBP methods provided by the manufacturer.
Cuff Connector
TEMP Probe and cable Each patient/weekly Refer to the cleaning and disinfection
methods provided by the manufacturer.
CO2 Module Each patient/weekly Refer to the cleaning and disinfection
methods provided by the manufacturer.

17.4 Environmental protection, safe disposal

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
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concerning disposal of the equipment, please contact aXcent.

Those accessories are consumables . Therefore, those accessories should be classified as medical
waste at the end of use. medical waste should be disposed of according to medical waste treatment
procedures of hospitals.
Since the main unit consists of electronics, it cannot be disposed of as regular waste. . The main
unit should be returned to manufacturer or dispose according to local guidelines for disposing of
electronics. Dispose according to Waste Electrical and Electronic Equipment (WEEE) directive in
European Union.
For relevant disposal information, please refer to the requirements of EN 50419: 2006.

WEEE Directive 2002/96/EC on waste electrical and electronic

equipment(WEEE).
The main unit consists of electronics, it cannot be disposed of as
regular waste. The main unit should be returned to manufacturer or
dispose according to local guidelines for disposing of electronics.
Dispose according to Waste Electrical and Electronic Equipment
(WEEE) directive in European Union.

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Chapter 18. Maintenance

Warning

⚫ If the hospitals or institutions using this instrument can’t implement a satisfactory

maintenance schedule, it will result in device failure and may endanger human health.

18.1 Checking

Check the following basic items before using the monitor:

◼ Check for any mechanical damage;

◼ Check all exposed wires, insertions and accessories;

◼ Check all instrument functions that may be used for patient monitoring and ensure that
the instrument is in good working condition.

If the instrument function has any sign of damage, do not use this monitor for any patient
monitoring. Please contact the hospital's professional maintenance personnel or our customer
service personnel.

Every 6-12 months or after each repair, a comprehensive examination must be performed by
trained and qualified technical service personnel, including functional safety checks; the
specific inspection items are as follows:

◼ Environment and power meet the requirements.

◼ Device and accessories have no mechanical damage.
◼ The power supply has no wear, and the insulation is good.
◼ Specified accessories are used.
◼ Alarm system is functioning correctly.
◼ Battery performance meets the requirements.
◼ Monitoring functions are in good working condition.
◼ Ground impedance and leakage current meet the requirements.

If the instrument function has any sign of damage, do not use this monitor for any patient
monitoring. Please contact the hospital's professional maintenance personnel or our customer
service personnel.

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All checks that require disassembling the instrument must be performed by qualified service
personnel. Safety and maintenance checks may also be carried out by the Company's
personnel.

18.2 Viewing Software Version Info

You can view the software version through the following steps:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [Monitor Information >>] → [Monitor Info] menu;

◼ [Monitor Info] menu displays the software version information of the monitor.

18.3 Maintenance Plan

The following tasks can only be done by qualified service personnel of aXcent. When the
following maintenance is needed, please contact your service representative. Before testing
or maintenance, clean and disinfect the device.

Inspection / Maintenance Item Frequency

Check the safety according to At least once every two years, after replacing the power
IEC 60601-1 supply or the monitor falls down.

Check all monitoring or At least once every two years, or when you suspect that the
measuring functions not listed measured value is not accurate.

NIBP leakage test At least once every two years, or follow hospital regulations

NIBP calibration At least once every two years, or follow hospital regulations

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18.4 ECG Calibration

In the process of using the monitor, the displayed ECG signals may be inaccurate due to
hardware or software problems, mainly shown as waveform amplitude becoming larger or
smaller. At this moment, you need to calibrate ECG.

Prepare the following instruments before testing:

◼ ECG simulator
◼ ECG cable
◼ Vernier caliper

The calibration method is as follows:

◼ Connect the ECG cable to the monitor.
◼ Connect the ECG electrodes to the ECG simulator.

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>] → [User Maintenance] menu;

◼ Select [Module Maintenance >>] → [Module Maintenance] menu;
◼ Select [ECG >>] → [ECG Maintenance] menu, and select [Calibration] to calibrate the
ECG;
◼ Measure the wave amplitude with a caliper; in different filtering modes, X0.25 is 2.5 ± 5%
(mm), X0.5 is 5.0 ±% 5 (mm), X1 is 10.0 ±% 5 (mm), and X2 is 20.0 ±% 5 (mm).
Comparing the amplitude of the square wave with the ruler, the error range should be
within 5%;
◼ When calibration is complete, select [Stop Calibration] to exit.

18.5 Touch Screen Calibration

You can follow the steps below to complete the calibration of the touch screen:

◼ Select [Menu] Smart Hotkey→[Main Menu];

◼ Select [User Maintenance >>]→ [User Maintenance] menu;

◼ Select [Cal. Touchscreen] to enter the touch screen calibration interface.
◼ Click on the screen and the alignment mark appears in different positions.
◼ If the touch screen calibration is finished after clicking three times, select [Ok] to exit the
calibration interface; if the touch screen isn’t completely calibrated, select [Retry] for re-
calibration.
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18.6 CO2 Calibration

Sidestream ISA module does not required regular calibration, and users can calibrate the
Sidestream module every 1 year if needed or when the measured deviation get too large.
Gas requirements in calibration：
Maintenance master software.
CO2 concentration：4%-11%
Oxygen concentration：45%-100%
All the gas must meet the precision：±0.03 vol% or ±(0.02 vol% + reading’s 0.1%),and pick
the higher value.
Steps of calibration go as follows：
1. Connecting the new Nomoline sampling tube to ISA gas analyzer.
2. Warm up for at least 1 minute.
3. Press “Pre span calibration zeroing” to ensure that the air surrounding gas is normal
(21%O2 and 0% CO2).
5.Open 【 Main Menu】 ->【User Maintenance】 ->【 Module Maintenance】 ->【CO2
Maintenance】,set the value in the【CO2 Calibration】to the same value with the input gas
concentration.
6. when the measured CO2 concentration gets stable, lick the【CO2 Maintenance】-【CO2
Calibration】button.
7. Check the CO2 parameter area to see if the gas reading is consistent with the measured CO2
concentration after the gas scale calibration is completed.

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Chapter 19. Accessories

Warning

⚫ Use the accessories specified in the Operator’s Manual; using other accessories may damage
the monitor, or cannot reach the performance claimed in this Manual.
⚫ The operating and storage environment of the monitor should meet the requirements of the
accessories. Please refer to the manual of the accessories for these requirements.
⚫ Disposable accessories can only be used once, because repeated use can cause performance
degradation.
⚫ If the packaging or accessories have any sign of damage, do not use such accessories.

19.1 Accessories List

Accessories are as follows:

Item ID Item Item Description Manufacturer

201-021 PAVO Option | 5.200 mAh battery (8-10 h) Sunhaury
201-022 PAVO Option | 7.800 mAh battery (12-13 h) JHT
202-002 MASIMO Nomoline ISA CO2 Sidestream EtCO2 Analyzer MASIMO
202-003 MASIMO IRMA CO2 Mainstream EtCO2 Analyzer MASIMO
202-007 IRMA airway adapter | neonate - infant | Disposable, box of 10 pcs MASIMO
106260
202-008 IRMA airway adapter | pediatric - adult | Disposable, box of 25 pcs MASIMO
106220
202-010 ISA Nomoline | sampling line | 3814 LH adult / pediatric airway adapter set MASIMO
Disposable, 25 pcs/box
202-016 CAPNO-S | standard CO2 [MASIMO protocol] Sidestream EtCO2 Analyzer inclusive: 6x KINGST
Water filter T4F disposable, 1x Modul
receptacle, 1x Info sticker for module
receptacle, 1x Sample line 2.4m
disposable, 1x T-shape airway adapter
disposable
202-017 CAPNO-M | standard CO2 [MASIMO Mainstream EtCO2 Analyzer inclusive: 1x KINGST
protocol] Airway adapter adult disposable, 1x Airway
adapter pediatric disposable
202-018 CAPNO-S water filter T4F Infant, pediatric, adults 25 pcs/box KINGST

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202-019 CAPNO-S sample line Lenght 2.4m 10 pcs/box KINGST

202-020 CAPNO-S T-shape ariway adapter Disposable 10 pcs/box KINGST
202-021 CAPNO-S module receptacle KINGST
202-023 CAPNO-M airway adapter | neonate - infant Disposable, 10 pcs/box KINGST
202-024 CAPNO-M airway adapter | pediatric - adult Disposable, 10 pcs/box KINGST
202-026 CAPNO-S | standard CO2 [RESPIRONICS Sidestream EtCO2 Analyzer inclusive: 6x KINGST
protocol] Water filter T4F disposable, 1x Modul
receptacle, 1x Info sticker for module
receptacle, 1x Sample line 2.4m
disposable, 1x T-shape airway adapter
disposable
202-027 CAPNO-M | standard CO2 [RESPIRONICS Mainstream EtCO2 Analyzer inclusive: 1x KINGST
protocol] Airway adapter pediatric/adult disposable,
1x Airway adapter neonatal/infant
disposable
203-001 ECG Cable | IEC | Clip | 3 Lead MEDLINKET
203-002 ECG Cable | IEC | Clip | 5 Lead MEDLINKET
203-003 ECG Cable | IEC | Clip | 10 Lead MEDLINKET
203-004 ECG Cable | IEC | Clip | 3 Lead | Neonate Extension cable and lead wire AMD
203-005 ECG Cable | AHA | Clip | 3 Lead MEDLINKET
203-006 ECG Cable | AHA | Clip | 5 Lead MEDLINKET
203-007 ECG Cable | AHA | Clip | 10 Lead MEDLINKET
203-008 ECG Cable | AHA | Clip | 3 Lead | Neonate Extension cable and lead wire AMD
203-009 ECG electrodes | Pediatric | 40 mm | ESVICO
Disposable | 25 pcs/box
203-010 ECG electrodes | Adult | 55 mm | Disposable ESVICO
| 25 pcs/box
203-011 ECG Cable | IEC | Snap | 3 Lead APK
203-012 ECG Cable | IEC | Snap | 5 Lead PLM
204-001 NIBP cuff | Adult thigh | Reusable VISTAR
204-002 NIBP cuff | Adult large | Reusable VISTAR
204-003 NIBP cuff | Adult | Reusable VISTAR
204-004 NIBP cuff | Child / Small adult | Reusable VISTAR
204-005 NIBP cuff | Infant / Child | Reusable VISTAR
204-006 NIBP cuff | Neonate / Infant | Reusable VISTAR
204-007 NIBP hose | Silicone grey | 3m VISTAR
204-008 NIBP tube coiled | TPU black | 3m VISTAR
204-010 NIBP cuff | Adult thigh | 45-56.5 cm | VISTAR
Disposable
204-011 NIBP cuff | Adult large | 35.5-46 cm | VISTAR
Disposable
204-012 NIBP cuff | Adult | 27.5-36.5 cm | Disposable VISTAR
204-013 NIBP cuff | Adult small | 20.5-28.5 cm | VISTAR

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Disposable
204-014 NIBP cuff | Child | 13.8-21.5 cm | Disposable VISTAR
204-015 NIBP cuff | Infant | 9-14.8 cm | Disposable VISTAR
204-016 NIBP cuff | Neonate #5 | 8-15 cm | VISTAR
Disposable
204-017 NIBP cuff | Neonate #4 | 7-13 cm | VISTAR
Disposable
204-018 NIBP cuff | Neonate #3 | 6-11 cm | VISTAR
Disposable
204-019 NIBP cuff | Neonate #2 | 4-8 cm | Disposable VISTAR
204-020 NIBP cuff | Neonate #1 | 3-6 cm | Disposable VISTAR
204-021 NIBP hose | Neonate | Blue | Disposable VISTAR
cuffs
207-001 SpO2 analog | Extension cable 1,5m For disposable neonates SpO2 probe AMD
207-002 SpO2 analog | Neonate | Sensor | Disposable MEDLINKET
207-003 SpO2 analog | Neonate | Wrap sensor | AMD
Reusable
207-004 SpO2 analog | Pediatric | Finger clip sensor | AMD
Reusable
207-005 SpO2 analog | Pediatric | Silicone soft sensor AMD
| Reusable
207-006 SpO2 analog | Adult | Silicone soft sensor | AMD
Reusable
207-007 SpO2 analog | Adult | Finger clip sensor | MEDLINKET
Reusable
207-008 SpO2 digital | Extension cable 1,5m For disposable neonates SpO2 probe AMD
207-009 SpO2 digital | Neonate | Sensor | Disposable AWS
207-010 SpO2 digital | Neonate | Wrap sensor | AWS
Reusable
207-011 SpO2 digital | Pediatric | Finger clip sensor | AWS
Reusable
207-012 SpO2 digital | Pediatric | Silicone soft sensor AWS
| Reusable
207-013 SpO2 digital | Adult | Silicone soft sensor | AWS
Reusable
207-014 SpO2 digital | Adult | Finger clip sensor | AWS
Reusable
208-001 SpO2 MASIMO | Extension cable | M-LNCS- MASIMO
10
208-002 SpO2 MASIMO | Adult | Finger clip | MASIMO
Reusable
208-003 SpO2 MASIMO | Pediatric | Finger clip | MASIMO
Reusable

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208-004 SpO2 MASIMO | Neonate | M-LNCS YI MASIMO

Multisite | Reusable
208-005 SpO2 MASIMO | Infant | Adhesive Sensor | MASIMO
Disposable
208-006 SpO2 MASIMO | Neonate + adult | Adhesive MASIMO
Sensor | Disposable
209-006 TEMP 2P | Adult + pediatric | Skin probe | MEDLINKET
2.25k | Reusable
209-007 TEMP 2P | Adult + pediatric | Rec/Es probe | MEDLINKET
2.25k | Reusab
209-008 QUICK TEMP | Infrared Ear temperature RADIANT
scanner
209-009 QUICK TEMP | Cover for ear temperature RADIANT
scanner, 20 pcs
209-018 TEMP 2P | Neonates | Skin probe | 2.25k | READY-MED
Reusable
209-019 TEMP 2P | Neonates | Rec/Eso probe | 2.25k READY-MED
| Reusable
210-001 Recorder | Thermal paper 50 mm x 20 m, 10 Tianjing Grand
rolls Paper
210-010 PAVO | Battery | 2.600 mAh Sunhaury
210-011 CETUS | Battery | 2.600 mAh Sunhaury
210-012 CETUS | Battery | 4.800 mAh Sunhaury
211-001 Trolley | PAVO + CETUS | 5-stand with basket CORITON
211-002 Wall mount | PAVO + CETUS | With basket CORITON
211-003 Fixation | PAVO + CETUS | Clamp for CORITON
horizontal rails
211-004 Transport bag | PAVO | Red YHB
211-005 Trolley | CETUS xl | 5-stand with basket CORITON
211-006 Wall mount | CETUS xl | With basket CORITON
212-001 Barcode Scanner | PAVO + CETUS | Incl. XAHX
bracket

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Chapter 20. Maintenance

20.1 Maintenance Introduction

Regular maintenance is essential to ensure that the equipment functions properly. This chapter
contains information on periodic testing and maintenance.

20.2 Maintenance Safety Information

WARNING
• Failure on the part of the responsible individual hospital or institution using this equipment
to implement a recommended maintenance schedule may cause undue equipment failure and
possible health hazards.
• No modification of this equipment is allowed.
• This equipment contains no user serviceable parts.
• The safety checks or maintenance involving any disassembly of the equipment should be
performed by professional service personnel. Otherwise, undue equipment failure and possible
health hazards could result.
• Do not open batteries, heat batteries to above 60 °C, incinerate batteries, or short the battery
terminals. Batteries may ignite, explode, leak or heat up, causing personal injury.
• The service personnel must be properly qualified and thoroughly familiar with the operation
of the equipment.
CAUTION
• The equipment and accessories shall not be served or maintained while in use with a patient.
• If you discover a problem with any of the equipment, contact your service personnel or aXcent.
• Use and store the equipment within the specified temperature, humidity, and altitude ranges.
• When disposing of the packaging material, be sure to observe the applicable waste control
regulations and keep it out of children’s reach.
• 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 aXcent.

NOTE
• If needed, contact the manufacture for circuit diagrams, component part lists, descriptions,
calibration instructions, or other information concerning the repair of the equipment.
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20.3 Maintenance and Testing Schedule

Follow the maintenance and testing schedule or local regulations to perform testing and
maintenance. Make sure to clean and disinfect the equipment before taking any tests and
maintenance.
The following table lists the maintenance and testing schedule:
Test/Maintenance Item Recommended Frequency
Performance Tests
Visual inspection Every day, before first use.
Measurement module performance test and 1. If you suspect that the measurement values
calibration are incorrect.
2. Follow any repairs or replacement of
relevant module.
3. Once a year for the CO2 test.
4. Once every two years for other parameter
module performance tests.
Analog output test If you suspect that the analog output function
does not work properly.
Nurse call test If you suspect that the nurse call function does
not work properly.
Electrical Safety Tests
Electrical safety tests Once every two years.
Other Tests
Power-on test Before use.
Recorder check 1. When the recorder is used for the first time.
2.Follow any repair or replacement of the
recorder.
Device integration check 1. When first installed.
2. Follow any repair or replacement of the
external device.
Battery check Functionality test:
1. When first installed.
2. When battery is replaced.
Performance test: Every three months or if the
battery runtime reduced significantly
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20.4 Testing Methods and Procedures

Except the following maintenance tasks, all other test and maintenance tasks should be
performed by aXcent qualified service personnel only.
■ Regular check, including visual inspection and power-on test
■ Printer and recorder tests
■ Battery check
If your equipment needs a safety test and performance test, contact the service personnel
20.4.1 Performing Visual Inspection
Visually inspect the equipment before its first used every day. If you find any signs of damage,
remove your
equipment from use and contact the service personnel.
Verify that the equipment meets the following requirements:
■ Environment and power supply specifications are met.
■ The monitor housing and display screen are free from cracks or other damages
■ The power cord is not damaged and the insulation is in good condition.
■ Connectors, plugs, and cables are not damaged and kinked.
■ Power cord and patient cables are securely connected with the equipment and modules.
20.4.2 Performing Power-on Test
The equipment automatically performs a selftest at startup. Check the following items for the
power-on test:
■ The equipment powers on properly.
■ The alarm system works properly.
■ The equipment displays properly
20.4.3 Testing the Recorder
To test the recorder, follow this procedure:
1. Start a recording task to print waveforms and reports.
2. Check that the recorder functions correctly.
3. Check that the printout is clear without missing dots.
20.4.4 Checking the Battery
For information on battery check, see 26.6.2 Checking Battery Performance.

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Chapter 21. Cybersecurity

21.1 Testing Methods and Procedures

From Electronic Medical Records (EMRs) to millions of connected medical devices, the flow
of patient information is increasing exponentially. With such an increase in the volume and modes
of data transmission, there comes a greater vulnerability to cybercrime. As a result, cybersecurity
and privacy is an ever-growing concern within the healthcare sector.
Therefore, for our products, we propose the following countermeasures as a way to improve
the cybersecurity of our products.
NO. Predictable events and Damage that can Control measures
sequences of events occur
1 Unauthorized access to the U01:Medical Set IP, gateway and port
system, malicious changes to personnel do not number by password
the system network have access to authorization
information, and arbitrary patient
setting parameters physiological
monitoring data,
which may lead to
delayed treatment
U02:The setting is
not reasonable and
may lead to patient
death
2 The system software cannot U03:System defect Installation/upgrade product
be upgraded due to the error in that prevents field service personnel insert
making the USB flash drive patients from being special software to update the
treated USB, shutdown and power on,
the system automatically
detects the U disk program,
automatic upgrade, U disk files
to match the software to read
the U disk.
3 The ability to recover the System does not Restore factory settings by
product's data, hardware or work, network simulating network anomalies
software after it has been communication
damaged or destroyed. fails.
4 Data Integrity and U05:Medical staff Network settings to ensure the
Authenticity: The ability of do not have real- connection through, run the
the product to ensure that data time access to process deliberately unplug the

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has not been changed in an patient monitoring network cable, after a few
unauthorized manner and data, which may minutes to connect, check the
comes from the creator or lead to delays in time and data before
provider. patient care. unplugging, whether the data
before unplugging
automatically uploaded.
5 The product's ability to defend H06:System cannot System software upgrade by
against cyber attacks and be upgraded password authorization
malware through
solidification measures.
6 Network IP and port number U08:Medical staff 1, quality assurance of the
configuration error or switch do not have access switch, which has been tested
equipment problems to patient and certified.
monitoring data, 2, reconnect data
which may lead to retransmission mechanism
delays in treatment

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Appendix A Specifications

A.1 Safety Specifications

A.1.1 Product Category

In accordance with classification specified in the European Medical Device Directive

93/42/EEC, this monitor is IIb type equipment. The monitor is classified as follows in
accordance with IEC 60601-1:

Category Name Specification

93/42/EEC ohm IIb

Medical Devices
Directive Category

Type of electric Grade I, internal and external power supply equipment

shock protection
When you question the integrity of the external protective earthing or
protective ground conductor parameter of the equipment, the device must
be powered by the internal power supply (battery).

Electric shock ECG/NIBP/SpO2/PR/TEMP/RESP: CF (defibrillation protection)

protection grade

Explosion Common equipment, no explosion protection

protection grade

Liquid inlet IPX1 (prevent water from entering when the water drips vertically)
protection grade

Operating mode Continuous

Movement Portable

A.1.2 Power Specifications

Parameter Specification
External AC power
Input voltage 100-240V~
Input current 1.0-0.5A
Frequency 50/60Hz
Fuse T1.6A 250V

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Internal power supply: Lithium-ion battery

Rated battery voltage d.c. 11.1V
Battery capacity 4800mAh, 2600mAh
Maximum supply time About 4~5 hours(4800mAh), 2~3 hours(2600mAh)
Charging time About 5~6 hours in power on state
Minimum supply 10.5V
voltage

A.2 Hardware Specifications

A.2.1 Physical Specifications

Dimensions 18.5 inch 470×328×193mm(L×W×T) (CETUS xL)

15.6 inch 398×302×185mm(L×W×T)(CETUS xL, CETUS x15)
12.1 inch 310×285×166mm (L×W×T)(CETUS x12)
8.4inch 175×275×175mm (L×W×T)(PAVO)
Weight < 10kg under standard configuration
Operating Condition Temperature: +5 ~ +40 ºC
Humidity: 10 ~ 85%
Barometric: 70 ~ 1060hPa
Operating Temperature 5ºC ~40 ºC

Environmental Relative Humidity 10% ~ 85%(non-condensing)

Atmospheric Pressure 70kPa~ 106kPa

Transport and Temperature -20ºC ~ 60ºC

Storage Relative Humidity 5% ~ 95%(non-condensing)

Environmental Atmospheric Pressure 70kPa ~ 106kPa

A.2.2 Display

Host Monitor
Type Color TFT LCD
Size Resolution
18.5 inch 1366×768 pixels (CETUS xL)
15.6 inch 1366×768 pixels (CETUS xL, CETUS x15)
12.1 inch 800×600 pixels (CETUS x12)
8.4inch 600×800 pixels (PAVO)
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A.2.3 Host LED

Alarm indicator 1 (yellow / red)

AC power indicator 1 (white)
Battery status indicator 1 (white)

A.2.4 Audio Instruction

Alarm sound (45 ~ 85dB), key-pressing sound, QRS sound, PR

Speaker sound.
Alarm sounds meet IEC 60601-1-8 standard.

A.2.5 Alarm Signal

Off or 1s, 2s, 3s, 4s, 5s, 6s, 7s, 8s; depending on the configuration;
Alarm delay
the default is 4s.
1min, 2min, 3min, 4min, 5min, 10min, 15min or infinite; depending
Pause duration
on the configuration; the default is 2min.

A.3 Data Storage

Long trend: 120h, minimum resolution: 1min

Trend data
Short trend: 1h, minimum resolution: 1s
Parameter alarm event 200 parameter alarm events
NIBP measurement results 1000 groups

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A.4 Measurement Specifications

A.4.1 ECG/TEMP/RESP Specifications

ECG Specifications
Standards compliant EN 60601-2-27/IEC 60601-2-27, GB 9706.25, IEC60601-2-25
3-lead I, II, III
Lead type 5-lead I, II, III, aVR, aVL, aVF, V
12-lead I, II, III, aVR, aVL, aVF, V1-V6
2.5mm/mV (×0.25), 5mm/mV (×0.5), 10mm/mV (×1.0), 20mm/mV
Display sensitivity
(×2.0)
Wave sweep speed 6.25mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s
Diagnostic mode 0.05Hz~100Hz
Monitor mode 0.5Hz~40Hz
Bandwidth
Surgery mode 1Hz~20Hz
Strong filter mode 5Hz~20Hz
CMRR >100dB
Notch 50/60Hz notch filter can be set to on or off
Differential input >5MΩ
impedance
Electrode polarization ±400mV
voltage range
Baseline recovery time <3s after defibrillation (in monitor and surgery mode)
Calibration signal 1mV (peak - peak), accuracy ±3%

Pacing pulse
For PACE pulses that meet the criteria below, PAEC will be marked on
the screen:
Pulse identification
Detection range: ±4mv ~ ±700mv
Pulse width: 0.2ms ~ 2.0ms
Average HR Calculate from 15s data
Interval of HR Calculate once every second
refreshing
HR change response Time from 80bpm to 120bpm: ≤ 10sec
time Time from 80bpm to 40bpm: ≤ 10sec
Tall T-wave For T-wave with 100ms QRS wave, 350ms QT period, 180ms duration
suppression and 1.2mV amplitude, the HR calculation won’t be affected
Alarm specifications Range (bpm) Step (bpm)
Adult: 16~300
HR upper limit
Pediatric: 16~350 1
HR lower limit Adult: 15~299
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Pediatric: 15~349
HR
Adult: 15bpm~300bpm
Measuring range 3/5-lead monitoring
Pediatric: 15bpm~350bpm
Resolution 1bpm
Heart rate measurement ±1bpm or ±1%, whichever is greater
error

TEMP
Standards compliant EN12470-4, ISO 80601-2-56
Measurement method Thermistor
Measuring range 5~50°C (41~122°F)
Resolution 0.1°C
Measurement accuracy ±0.2°C
Number of channels Two
Quick Temp (Optional)
Type Infrared Ear Thermometer
Measurement method Tympanic
Displayed range: 34~42.2℃ (93.2~108 F°）
Operation ambient 10~40℃（50~104°F）
temperature range:
Accuracy for displayed ≥35℃（95.9°F）~≤42.2℃（107.6°F）range ±0.2℃（0.4°F）
temperature range: ＜35℃（95.9°F）~≥34℃（93.2°F）range ±0.3℃（0.5°F）
Alarm specifications Range Step
T1/T2 upper limit 0.1°C~50.0°C 0.1°C
T1/T2 lower limit 0°C~49.9°C 0.1°F
TD upper limit 0~50°C

RESP
Measurement method Thoracic electrical bioimpedance method
Measuring lead Lead I, II
Wave gain ×0.25, ×0.5, ×1, ×2
Respiratory impedance 0.5-5Ω
range
Baseline impedance 500-4000Ω
Gain 10 grades
Scan speed 6.25mm/s, 12.5 mm/s, 25mm/s

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A.4.2 NIBP Specifications

EN 60601-2-30/IEC 60601-2-30, EN 1060-1, EN 1060-3, EN1060-4

Standards compliant
EN/IEC 60601-1.
Measurement method Automatic oscillometric method
Operating mode Manual, automatic, continuous
Useful life 100, 000 times
Measurement interval 1/2/3/4/5/10/15/30/60/90/120/180/240/480min
in automatic mode
Typical measurement 20~40s
time
Adult Pediatric Neonatal
Systolic blood
40-270 40-200 40-135
Normal mode pressure
measuring range Mean blood
20-230 20-165 20-120
(mmHg) pressure
Diastolic blood
10-210 10-150 10-100
pressure
Maximum average error: ±5mmHg
Measurement accuracy
Maximum standard deviation: 8mmHg
Resolution 1mmHg
Default Pressure setting range
Adult 150mmHg 80~240mmHg
Initial inflation pressure
Pediatric 100mmHg 80~200mmHg
Neonatal 100mmHg 60~120mmHg
Overpressure Adult: 300mmHg
protection point Pediatric: 240mmHg
(software) Neonatal: 150mmHg
Overpressure Adult: 320~330mmHg
protection point Pediatric: 265~275mmHg
(hardware) Neonatal: 160~165mmHg
Pressure accuracy ±3mmHg
Electrical characteristics
Supply voltage 10V~14V DC
Maximum power 3.6w
consumption
Quiescent current 50mA
Maximum current 180mA
during measurement
Maximum current 300mA
during inflation

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A.4.3 SpO2 Specifications

SpO2 Module
Standards compliant ISO 80601-2-61
Display range 0%~100%
Parameter monitoring Perfusion Index(PI) and Pleth Variability Index(PVI)
SpO2 display 1%
resolution
SpO2 checking 2% (70%~100%); not define when lower than 70%
accuracy
SpO2 alarm preset Upper alarm limit 1%~100%
limits Lower alarm limit 0%~99%
SpO2 alarm preset ±1%
accuracy
SpO2 alerting signal No delay
generates a delay
SpO2 value refresh 1s/time
period
SpO2 value refresh ＜ 10s
delay
Low sensitivity 7～8s
Average period Intermediate sensitivity 4～6s
Advanced sensitivity 2～3s
Low sensitivity ＜8s
Alarm condition delay
Intermediate sensitivity ＜6s
period
Advanced sensitivity ＜3s
Alarm sign generates 0s
delay period
PR
Measuring range 30~254bpm
Resolution 1%
Accuracy ±2% or ±2bpm

Masimo SpO2 Module

SpO2

Measurement range 0% to 100%

Resolution 1%
70% to 100%：±2%（adult/pediatric, non-motion conditions）
70% to 100%：±3%（neonate, non-motion conditions）
Accuracy
70% to 100%：±3%（motion conditions）
0% to 69%，unspecified

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Average time 2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s

PR

Measurement range 25 bpm to 240 bpm

±3 bpm（non-motion conditions）
Accuracy
±5 bpm（motion conditions）
Resolution 1 bpm

PI

Measurement range 0.05% to 20%

A.4.4 CO2 Specification

Required standard EN 60601-1
Measurement method Mainstream IRMA CO2, Sidestream ISA CO2

Mainstream module

CO2 Measurement range 0~25%

Resolution 0.1 mmHg

Accuracy 0 - 40 mmHg ± 2 mmHg

41 - 70 mmHg ± 5% of reading
71 - 100 mmHg ± 8% of reading
101 - 150 mmHg ± 10% of reading
System response time <1 s
Warm-up time 10s
Inspiratory rise time CO2≤90ms
(@10 l/min)
AwRR measurement 0~150 bpm
range
renewal period Show the inspiration frequency after 3 times inhale& exhale, and
update the average after each inhale& exhale.
Temperature requirement Operating 0~40℃/32~104℉
temperature
Storage and -40~75℃/-40~167℉
transportation
temperature
Humidity requirement Operating Humidity 10~95% RH, no condensation
Storage and 5~100% RH, condensation
transportation
Humidity
Air pressure requirement Air pressure 525~1200 hpa

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(525 hpa Corresponding to the altitude of 4572

m / 1500 ft)
Storage and 500~1200 hpa
transportation
temperature
*: The accuracy above is under the standard condition.
In all situations (valid in the conditions of specified operating temperature and humidity, except
the specified interfered gas in the “interference gases and water vapor”, CO2 measurement
accuracy ± (0.3% + reading’s 4%)
Impact of interference gases and water vapor
Gas or water vapor * Concentration (%) Impact
Enflurane soflurane, 5% reading’s +8%
Sevoflurane
Desflurane 15% reading’s +12%
Xe(xenon) 80% reading’s -10%
He(helium) 50% reading’s -6%
*:1. Nitrous oxide, halothane, ethanol and methane , etc are negligible interference;
2. The instructions above are under the impact of mycelium concentration. For example,50%
helium would lower 6% CO2 reading, which means that the measured CO2 concentration will be
(1-0.6)*5.0% = 4.7% CO2 if the gas measured contains mixture of 5% CO2 and 50% helium
3. Gas is in accordance with EN ISO 21647:2004 standard.

Sidestream module

CO2 measurement range 0~25%

Resolution 0.1%

Accuracy 0~15 ± (0.2% +2%)

15~25 not specified
System response time <3s
Warm-up time <10s (Report the concentration and achieve the highest accuracy)
Typical rise time CO2 ≤200ms
(Sample flow rate of 50
l/min)
AwRR measurement 0~150±1 rpm
range
Renewal period Show the inspiration frequency after 3 times inhale& exhale, and
update the average after each inhale& exhale.
Temperature requirement Operating 0~50℃/32~122℉
temperature
Storage and -40~75℃/-40~167℉
transportation
temperature

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Humidity requirement Operating Humidity < 4Kpa 水(no condensation)

(95 %RH,30℃)
Storage 5~100% RH, no condensation
Humidity (100 %RH,40℃)
Operating air 52.5~120 kpa
pressure (525 hpa Corresponding to the altitude of 4572
Air pressure requirement
m / 1500 ft)
storage air pressure 20~120 kpa
Calibration No need to make scale calibration of infrared pool; generate the
automatical zeroing calibration and execute once every 24 hours
*: The accuracy above is under the standard condition (a dry gas Suitable for 22 + 5 ℃ and + 40
1013 hpa).
In all conditions (valid in the conditions of specified operating temperature and humidity, except
the specified interfered gas in the “interference gases and water vapor”), CO2 measured accuracy
± (0.3% + reading’s 4%)
Impact of interference gases and water vapor
Gas or water vapor Condensation (%) Impact
Enflurane, Soflurane, 5% reading’s +8%
Sevoflurane
Desflurane 15% reading’s +12%
Xe(xenon) 80% reading’s -10%
He(helium) 50% reading’s -6%
*: 1. Nitrous oxide, halothane, ethanol and methane are negligible interference;
2. The instructions above are under the impact of mycelium concentration. For example,50%
helium would lower 6% CO2 reading, which means that the measured CO2 concentration will be
(1-0.6)*5.0% = 4.7% CO2 if the gas measured contains mixture of 5% CO2 and 50% helium
3. Gas is in accordance with EN ISO 21647:2004 standard.

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Appendix B EMC
This product complies with EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General
requirements for safety - Collateral standard electromagnetic compatibility requirements and
tests

Notes:
⚫ Using unqualified accessories, sensors and cables will increase the electromagnetic
emission and reduce the electromagnetic immunity of the device.

⚫ Do not put the device close to other devices or stack together. When necessary, observe
the device closely to ensure that it runs normally in the environment.

⚫ The device requires special EMC protection, and it is necessary to install and maintain it
in the environment that meets the following EMC information.

⚫ Even if other devices comply with CISPR emission requirements, they may also cause
interference to this device.

⚫ When the input signal amplitude is smaller than the minimum amplitude specified in the
technical specifications, it may result in inaccurate measurements.

⚫ Mobile communication devices or wireless network devices may have an impact on the
device.

Electromagnetic Emission Guidelines and Declarations

Patient Monitor should be used in the specified electromagnetic environment. The user should
ensure that the device is used in the following electromagnetic environment.

Emission test Compliance Electromagnetic environment - Guide

RF emission Group 1 The device uses radio frequency energy only when
CISPR11 the internal function is running, and thus its RF
emission is very low, and won’t cause
electromagnetic interference to nearby electronic
equipment.
RF emission ClassA This device is suitable for the public low-voltage
CISPR11 power supply network that isn’t connected to
Harmonic emission ClassA residence directly.
IEC 61000-3-2
Voltage fluctuations and Conform
flicker IEC 61000-3-3
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Guidance and Declaration - Electromagnetic Immunity

Patient Monitor is suitable for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity test IEC60601 test Compliance level Electromagnetic
level environment - guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,
discharge (ESD) ±15 kV air ±15 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
IEC 61000-4-4 ±1 kV I/O for ±1 kV I/O for commercial or hospital
input/output lines input/output lines environment.
(>3 m) (>3 m)
Surge IEC ±1 kV differential ±1 kV differential
61000-4-5 mode mode
±2 kV common ±2 kV common
mode mode
Voltage dips, <5 % UT (>95 % dip <5 % UT (>95 % dip Mains power quality should
short in UT) for 0.5 cycle in UT) for 0.5 cycle be that of a typical
interruptions and commercial or hospital
voltage variations 40 % UT (60 % dip 40 % UT (60 % dip environment. If the user of
on power supply in UT) for 5 cycles in UT) for 5 cycles our product requires
input lines IEC continued operation during
61000-4-11 70 % UT (30 % dip 70 % UT (30 % dip power mains interruptions,
inUT) for 25 cycles in UT) for 25 cycles it is recommended that our
product be powered from
<5 % UT (>95 % dip <5 % UT (>95 % dip an uninterruptible power
in UT) for 5 s in UT) for 5 s supply or a battery.
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 HZ) fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.

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Guidance and Declaration - Electromagnetic Immunity

Patient Monitor is suitable for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.

Immunity test IEC 60601 Test level Compliance level

Conduced RF IEC61000-4-6 3 Vrms 3 Vrms

150k to 80M Hz
Radiated RF IEC61000-4-3 3V/m 3V/m
80M to 2.5G Hz
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of the
device, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance:

d－1.2√𝑝 (d－3.5√𝑝)

d－1.2√𝑝 (Resp: d－3.5√𝑝) 80 to 800MHz

d－1.2√𝑝 800M to 2.5GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range b Interference may occur in the
vicinity of equipment marked with the following symbol:

Note 1: From 80 MHz to 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 device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the device.
b
Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m.

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Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and The device

The device is suitable for use in an electromagnetic environment in which radiated RF disturbance
are controlled. The customer or the user of the device can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the device as recommended below, according to the
maximum output power of the communication equipment.
Rated Maximum Separation Distance Meters (m) Corresponding to Frequency of
Output power of Transmitter
Transmitter Watts (W) 150k to 80MHz 80M to 800MHz 800M to 2.5GHz
7
d＝3.5√𝑝 d＝3.5√𝑝 d＝[ ]√𝑝
3
0.01 0.35 0.35 0.23
0.1 1.11 1.11 0.74
1 3.5 3.5 2.34
10 11.07 11.07 7.38
100 35 35 23.24
For transmitters at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: From 80 MHz to 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.

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Appendix C Alarm Information

This chapter lists some important physiological and technical alarm information, and some
alarms are not necessarily listed.

Note that in this chapter: L column indicates the default alarm level: H indicates high level, M
indicates middle level, L indicates low level, and “*” indicates level set by the user.

Corresponding countermeasures are listed for each alarm message. If you operate in
accordance with the countermeasures but the problem persists, contact your service personnel.

C.1 Physiological Alarm Information

Source Alarm message L Causes and countermeasures

HR Too High HR value is higher than the upper alarm limit or lower
than the lower alarm limit. Check the patient's
M* physiological condition, and check if the patient
HR Too Low
category and alarm limit settings are appropriate for
the patient.
PVCs value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
PVCS Too High M* physiological condition, and check if the patient
category and alarm limit settings are appropriate for
the patient.

ECG Asystole H The patient has arrhythmia. Check the patient's

VF/VTA H condition, electrodes, cables and lead wires.
R on T M*
Frequent PVC M*
Couplet PVC M*
Single PVC M*
PVC Bigeminy M*
PVC Trigeminy M*
Tachycardia M*
Bradycardia M*
Miss Beat M*
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Source Alarm message L Causes and countermeasures

Pacemaker Not Capture H Pacemaker works abnormally; check the pacemaker.
Pacemaker Not work H
H The patient ECG signal is too weak, and the system
ECG Signal weak can’t analyze. Check the patient's condition,
electrodes, cables and leads.
ST-I Too High ST value is higher than the upper alarm limit or lower
ST-I Too Low than the lower alarm limit. Check the patient's
ST-II Too High physiological condition, and check if the patient
M*
ST-II Too Low category and alarm limit settings are appropriate for

ST-III Too High the patient.

ST-III Too Low

RR Too High Patient PR value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
M* physiological condition, and check if the patient
RR Too Low
category and alarm limit settings are appropriate for
Resp the patient.
The patient's respiratory signal is too weak, and the
Apnea(RESP) H system can’t analyze. Check the patient's condition,
electrodes, cables and leads.
RESP ARTIFACT H* Respiration heartbeat interference
T1 Too High T1/T2 value is higher than the upper alarm limit or
T1 Too Low lower than the lower alarm limit. Check the patient's
T2 Too High physiological condition, and check if the patient
category and alarm limit settings are appropriate for
T2 Too Low
the patient.
Temp M*
TD value is higher than the upper alarm limit or lower
than the lower alarm limit. Check the patient's
TD Too High physiological condition, and check if the patient
category and alarm limit settings are appropriate for
the patient.
SPO2 Too High SpO2 value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
SpO2 M*
SPO2 Too Low physiological condition, and check if the patient
category and alarm limit settings are appropriate for

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Source Alarm message L Causes and countermeasures

the patient.
PR Too High SpO2 value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
physiological condition, and check if the patient
PR Too Low
category and alarm limit settings are appropriate for
the patient.
NIBP signal weak NIBP value is higher than the upper alarm limit or
NIBP-Sys Too High lower than the lower alarm limit. Check the patient's
NIBP-Sys Too Low physiological condition, and check if the patient
NIBP M*
NIBP-Mean Too High category and alarm limit settings are appropriate for

NIBP-Mean Too Low the patient.

NIBP-Dia Too High

IBP Art-Sys too high M* ArtSys value has risen above the high alarm limit or
Art-Sys too low M* fallen below the low alarm limit. Check the patient’s
condition and check if the patient category and alarm
limit settings are correct.
The other entitles corresponding pressure exceed the
limit in the same way.
EtCO2 too high M* CO2 value has risen above the high alarm limit or fallen
CO2 EtCO2 too low M* below the low alarm limit. Check the patient’s condition
and check if the patient category and alarm limit settings
FiCO2 too high M* are correct.

AWRR too high M*

AWRR too low M*
CO2 Apnea H The patient stops breathing, or the respiration signal
was so weak that the monitor cannot perform
respiration analysis. Check the patient’s condition and
the RM connections.

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C.2 Technical Alarm Information

Source Alarm message L Causes and countermeasures

Connect to AC power supply, and charge the
System Battery Low H battery, and power with the battery as needed after
fully charged.
ECG ECG Comm. Stop H ECG module failure, or communication failure
ECG Comm. Error H between the module and the host; please restart the
ECG Config Error H device.
ECG Self check
H
Error
ECG Lead Off M* The electrodes are not connected to the patient
ECG YY OFF (YY firmly or fall off, or lead wires and the main cable
is a lead name) M* fall off. Check the connection of electrodes and
lead wires.
TEMP1 Sensor Off L The temperature sensor falls off from the patient.
Temp
TEMP2 Sensor Off L Check the sensor connection.
SPO2 Comm. Stop H SpO2 module failure, or communication failure
SPO2 Comm. Error between the module and the host; please restart the
H
device.
SPO2 No Sensor L SpO2 sensor falls off from the patient or monitor,
SPO2 Sensor Off L malfunctions, or sensor other than specified in this
SPO2 Sensor Error L Manual is used. Check the sensor mounting
SpO2 SPO2 Search position, whether the sensor is damaged or sensor
L
Timeout type. Reconnect the sensor or use new sensor.

SPO2 Search Pulse L Sensor signal is poor or too weak. Check the
SPO2 Signal patient's condition, and place the sensor in a
L
Unstable suitable position. If the failure persists, replace the
SPO2 Failure L sensor.
SPO2 Signal Weak L
SpO2 SPO2 No Cable No Cable
L
(Masimo Connected
Cable Expired L Cable Life Expired
SpO2
module) Incompatible Cable L Incompatible Cable
Unrecognized L Unrecognized Cable

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Source Alarm message L Causes and countermeasures

Cable
Replace cable L Defective Cable/Cable Life Expired
Cable Near Cable Life Near Expiration
L
Expiration
SPO2 No Sensor No Sensor Connected
L
Connected
Sensor Expired L Sensor Life Expired
Incompatible Incompatible Sensor
L
Sensor
Unrecognized Unrecognized Sensor
L
Sensor
Replace sensor L Defective Sensor
Check Cable / Check Cable and Sensor Fault
L
Sensor Fault
Sensor Near Sensor Life Near Expiration
L
Expiration
SPO2 No Adhesive No Adhesive Sensor
L
Sensor
Adhesive Sensor Adhesive Sensor Life Expired
L
Expired
Defective Adhesive Defective Adhesive Sensor/Adhesive Sensor Life
L
Sensor Expired
Incompatible Incompatible Adhesive Sensor
L
Adhesive Sensor
Unrecognized Unrecognized Adhesive Sensor
L
Adhesive Sensor
Defective Adhesive Defective Adhesive Sensor
Sensor L

Sensor Initializing L Sensor Initializing

SPO2 Sensor Off Sensor Off Patient
L
Patient
SPO2 Pulse Search L Pulse Search
SPO2 Interference Interference Detected
L
Detected
SPO2 Low Low Perfusion Index
L
Perfusion Index
SPO2 Demo Mode L Demo Mode
Adhesive Life Near Adhesive Life Near Expiration
L
Expiration
Check Sensor L Check Sensor Connection

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Source Alarm message L Causes and countermeasures

Connection
SpO2 Only Mode SpO2 Only Mode
SPO2 Low Signal Low Signal IQ
L
IQ
asimoSET MasimoSET Processing Active
L
Processing Active
SPO2 Too Much Too Much Ambient Light
L
Ambient Light
NIBP Comm. Stop H NIBP module failure, or communication failure
NIBP Comm. Error L between the module and the host; please restart the
NIBP Self check device.
H
error
NIBP CFG Error H
NIBP system error H If failure occurs during measurement, the system
NIBP
can’t analyze and calculate. Check the patient's
Measurement
L condition, check the connections or replace the
timeout
cuff, and then re-test.
The used cuff does not match the set patient
Cuff type error L category. Verify the patient category and replace
the cuff.
NIBP cuff isn’t placed or connected properly, or
Cuff loose or no cuff L
there is gas leak.
Cuff leak L Check cuff and inflation tube.
Ambient atmospheric pressure is abnormal.
Confirm that the environment complies with the
Air pressure error L
monitor's specifications, and check whether there
are special reasons affecting ambient pressure.
NIBP The measured blood pressure of the patient
NIBP over range L
exceeds the measuring range.
Patient's pulse may be weak or cuff is too loose.
Check the condition of the patient, and place the
NIBP signal weak L
cuff in a suitable position. If the failure persists,
replace the cuff.
NIBP signal unstable Excessive movement may result in too much
L
motion artifact or interference in the signal during

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Source Alarm message L Causes and countermeasures

measurement.
NIBP signal Motion signal amplitude is too large due to
L
saturated movement and other reasons.
NIBP over pressure Cuff overpressure, and gas blockage may occur;
L
check the gas path, and then re-measure.
NIBP module reset error; check the gas path is
Module reset failed L
blocked, and then restart the measurement.
CO2 CO2 communication The CO2 module fails or module and host
H
stop connection disconnected, reconnect the CO2
CO2 communication module to monitor.
H
error
CO2 pipe off L Check CO2 pipe connection situation
Check adapter L Check CO2 connected adapter or sampling pipes
Check sampling pipe L
Software error(CO2） H CO2 module fail, contact the maintenance staff.
Sensor error(CO2) L Check CO2 sensor matched or not.
CO2 exceed the The measured value exceed the measurement
L
measurement range. range claimed.
CO2 sensor high Check, remove heat source or waiting for the
L
temp module to recover.
An error occurred in the airway pressure. Check
CO2 Airway high
L the patient connection and patient circuit, and then
press
restart the monitor.
CO2 check Cal L CO2 preform a calibration
CO2 checking Cal CO2 calibration module fails, please make sure the
L
failure gas path etc, to recalibrate.

BIS connected BIS connected demo simulator, At this moment is

L
simulator. to demonstrate, not measuring patient.

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Appendix D Default Parameter

Configuration
This chapter lists the important factory default settings of different departments in monitor
configuration mode. Users can not change the default configuration, but can modify the settings
as required and save as user-defined configuration.

Module defaults
Module Option
Adult Pediatric
Alarm level Mid Mid
Alarm record Off Off
Lead type 5-lead 5-lead
Calculation channel Auto Auto
Power frequency suppression On On
Alarm limits 50~120 on 75~160 on
ST segment
Off Off
ST analysis
segment Alarm level Mid Mid
analysis Alarm record Off Off
Alarm limits -0.2~0.2 on -0.2~0.2 on
Alarm level Mid Mid
ECG Alarm record Off Off
Alarm limits 0~10 on 0~10 on
Alarm
Arrhythmia On On
switch
analysis ARR
Alarm
alarm Mid Mid
level
settings
Alarm
Off Off
record
Gain x1 x1
Wave velocity 25.0mm/s 25.0mm/s
Filter mode Monitor Monitor
Wave color Green Green
Wave style Color scale Color scale
Alarm level Mid Mid
Alarm record Off Off
Pressure unit mmHg mmHg
NIBP Measurement mode Adult Child
Interval Manual Manual
Display color White White
Pre-inflation value 150 100

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Systolic blood pressure limit 90~160 on 70~120 on

Mean blood pressure limit 60~110 on 50~90 on
Diastolic blood pressure limit 50~90 on 40~70 on
Alarm level Mid Mid
Alarm record Off Off
Alarm limits 90~100 on 90~100 on
SPO2
Wave velocity 25.0 25.0
Wave color Cyan Cyan
Wave style Line Line
Alarm level Mid Mid
Alarm record Off Off
Apnea alarm 20 sec 20 sec
Alarm limits 8~30 on 8~30 on
RESP
Gain x1 x1
Wave velocity 12.5 12.5
Wave color Yellow Yellow
Wave style Line Line
Alarm source SPO2 SPO2
Alarm level Mid Mid
PR
Alarm record Off Off
Alarm limits 50~120 on 75~160 on
Alarm level Mid Mid
Alarm record Off Off
Display color White White
TEMP Temperature unit °C °C
T1 alarm limits 36.0~39.0 on 36.0~39.0 on
T2 alarm limits 36.0~39.0 on 36.0~39.0 on
TD alarm limits 0.0~2.0 on 0.0~2.0 on
Alarm switch On On
Alarm level Mid Mid
Alarm record Off Off
Pressure unit mmHg mmHg
Operation mode Standby Standby
Apnea time 20s 20s
CO2
O2 compensation Low Low
N2O compensation Off Off
Wave scale 40 40
EtCO2 alarm limits 15~50 20~50
FiCO2 alarm limits 0~4 0~4
AwRR alarm limits 8~30 8~30

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aXcent medical GmbH

Jösef-Görres-Platz 2
56068 Koblenz / Germany
Tel.: +49 261 3011 117
info@axcentmedical.com
www.axcentmedical.com

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