Doc. No.:NR-TP-1211-037 version:7.

Venus/Taurus/Pisces/Virgo/Aries/Gemini/Aquarius

Multi-parameter Patient Monitor

Operator’s Manual

Northern Meditec Limited

 Doc. No.:NR-TP-1211-037 version:7.1

© Copyright 2016-2018 Northern Meditec Limited. All rights reserved.

Release time: 2021-03

Revision: 7.1
 Doc. No.:NR-TP-1211-037 version:7.1

Notice
Thanks for purchasing Northern Meditec 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: Venus, Taurus, Pisces, Virgo,Aries,Gemini,Aquarius

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 use for monitoring, displaying and
alarming of more than one vital physiological including ECG, respiration (RESP),
pulse rate (PR), blood oxygen saturation (SPO2), noninvasive blood pressure (NIBP),
temperature (TEMP), carbon dioxide (CO2) of a single patient for adult and pediatric
in hospital.

Manufacturer: Northern Meditec Limited

Registered Address: Room 502、501 Building A, Room 401 Building C, Jin Wei Yuan Industrial

Park,Pingshan District, Shenzhen, P.R.China

Manufacturing Room 502、501 Building A, Room 401 Building C, Jin Wei Yuan Industrial

Address: Park,Pingshan District, Shenzhen, P.R.China

Version: 7.1

Date of Issue: May 17, 2022

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Intellectual Property Rights

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

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

However, Northern 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. Northern does not provide license conferred by patent law to
any other parties. Northern does not assume legal responsibility for the legal consequences resulting from violating
the patent law and the rights of any third party.

CE mark

EC Representative

Name: Umedwings Netherlands B.V.

Address: Treubstraat 1, 2288 EG Rijswijk,,the Netherlands

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Statement
Northern 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, Northern 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 Northern;

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

 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 Northern within 30 days from the date of installation; if the Warranty
Card for the product purchased is not sent to Northern on time, the warranty period will be calculated after 45
days from the “Delivery Date” marked on the packing box.

Northern 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 Northern.

 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 Northern.

 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
Northern for maintenance is assumed by the user. For the maintenance due to any reason other than the
abovementioned causes, Northern will charge for service, and the user needs to pay additional costs for
maintenance and parts.

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

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

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After-sales Service Unit

Name: Northern Meditec Limited Customer Service Department

Address: Room 502, 501 Building A, Room 401 Building C, Jin Wei Yuan Industrial Park,Pingshan District,
Shenzhen, P.R.China

Postal Code: 518118

Website: www.northernmeditec.com

Email: [email protected]

Tel: + 86 755 27952733

Fax: +86 755 86528647

EC-Representative: Umedwings Netherlands B.V.

Address: Treubstraat 1,2288EG,Rijswijk,The Netherlands

Website: www.umedwings.eu

E-mail: [email protected]

Tel: +31（0）642758955

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.

Service life
Complete machine 5 years

Date of production
See product Label

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 ................................................................................................................................................26
2.3 Screen Display ................................................................................................................................................... 29
2.4 Smart Hotkeys .................................................................................................................................................... 31
Chapter 3. Basic Operation .................................................................................................................................... 33
3.1 Installation ..........................................................................................................................................................33
3.1.1 Unpacking ............................................................................................................................................... 33
3.1.2 Environmental Requirements ................................................................................................................. 33
3.2 Connecting to AC Power ....................................................................................................................................34
3.3 Turning on .......................................................................................................................................................... 34
3.3.1 Checking the Monitor ............................................................................................................................. 34
3.3.2 Starting the Monitor ................................................................................................................................35
3.3.3 Connecting the Sensor ............................................................................................................................ 35
3.3.4 Starting Monitoring .................................................................................................................................35
3.4 Turning off ..........................................................................................................................................................36
3.5 Basic Operation ..................................................................................................................................................36
3.5.1 Using the Shuttle .....................................................................................................................................36
3.5.2 Using Keys .............................................................................................................................................. 36
3.5.3 Using the Touch Screen .......................................................................................................................... 36
3.5.4 Using Soft Keyboard ...............................................................................................................................37
3.5.5 Using Menu .............................................................................................................................................37
3.6 Operating Mode ................................................................................................................................................. 38
3.7 Measurement Setup ............................................................................................................................................38
3.8 Freezing Waves .................................................................................................................................................. 39
3.9 Other Common Setup .........................................................................................................................................39
3.9.1 Defining the Monitor .............................................................................................................................. 39
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3.9.2 Language Setup .......................................................................................................................................39

3.9.3 Date and Time ......................................................................................................................................... 40
3.9.4 Volume Control ....................................................................................................................................... 40
3.9.5 Setting Parameter Unit ............................................................................................................................ 40
Chapter 4. Patient Information Management ......................................................................................................... 42
4.1 Patient Setup Menu ............................................................................................................................................ 42
4.2 Admitting a Patient Quickly ...............................................................................................................................43
4.3 Admitting a Patient .............................................................................................................................................43
4.4 Editing Patient Info ............................................................................................................................................ 45
4.5 Discharging a Patient ......................................................................................................................................... 45
Chapter 5. User Interface ....................................................................................................................................... 46
5.1 Selecting User Interface ..................................................................................................................................... 46
5.2 Interface Introduction .........................................................................................................................................47
5.2.1 Normal Screen .........................................................................................................................................47
5.2.2 Big Numerics .......................................................................................................................................... 48
5.2.3 ECG 7-Lead Half-Screen ........................................................................................................................49
5.2.4 ECG 7-Lead Full-Screen ........................................................................................ 错误！未定义书签。
5.2.5 ECG 12-Lead Full-Screen ...................................................................................... 错误！未定义书签。
5.2.6 OxyCRG Screen ......................................................................................................................................49
5.2.7 DynaTrend Screen ...................................................................................................................................51
Chapter 6. Alarm ....................................................................................................................................................52
6.1 Alarm Type ......................................................................................................................................................... 52
6.2 Alarm Level ........................................................................................................................................................53
6.3 Alarm Mode ....................................................................................................................................................... 53
6.3.1 Light Alarm ............................................................................................................................................. 53
6.3.2 Audible Alarm ......................................................................................................................................... 54
6.3.3 Alarm Info ............................................................................................................................................... 54
6.3.4 Parameter Flashing ..................................................................................................................................54
6.4 Alarm States ....................................................................................................................................................... 54
6.4.1 Silence ..................................................................................................................................................... 55
6.4.2 Alarm sound off .......................................................................................................................................55
6.4.3 Alarm Pause ............................................................................................................................................ 55
6.4.4 Alarm off ................................................................................................................................................. 56
6.5 Alarm Setup ........................................................................................................................................................56
6.5.1 Setting the Alarm Sound ......................................................................................................................... 57
6.5.2 Setting the Alarm Delay Time ................................................................................................................ 57
6.5.3 Setting a Parameter Alarm ...................................................................................................................... 57
6.6 Latch Alarm ........................................................................................................................................................58
6.7 Manual Event ..................................................................................................................................................... 59
Chapter 7. ECG ...................................................................................................................................................... 59
7.1 Overview ............................................................................................................................................................ 59
7.2 Safety Information ............................................................................................................................................. 60

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7.3 Monitoring Steps ................................................................................................................................................60

7.3.1 Preparation .............................................................................................................................................. 60
7.3.2 Selecting Lead .........................................................................................................................................61
7.3.3 Lead Name and Corresponding Color .................................................................................................... 61
7.3.4 Installing Electrodes ................................................................................................................................62
7.3.5 Checking the Pacemaking Status ............................................................................................................64
7.4 ECG Display ...................................................................................................................................................... 64
7.5 Alarm Setup ........................................................................................................................................................65
7.6 ECG Setup ..........................................................................................................................................................65
Chapter 8. Resp ...................................................................................................................................................... 68
8.1 Overview ............................................................................................................................................................ 68
8.2 Safety Information ............................................................................................................................................. 68
8.3 Placing Electrodes for Respiration Monitoring ................................................................................................. 68
8.3.1 Adjusting Position of Respiration Electrode .......................................................................................... 69
8.3.2 Cardiomotility Superimposing ................................................................................................................69
8.4 Resp Display ...................................................................................................................................................... 69
8.5 Resp Setup ..........................................................................................................................................................70
8.5.1 Setting Apnea Time .................................................................................................................................70
8.5.2 Adjusting Wave Gain .............................................................................................................................. 71
8.5.3 Setting Scanning Speed ...........................................................................................................................71
8.6 Alarm Setup ........................................................................................................................................................71
Chapter 9. PR ......................................................................................................................................................... 72
9.1 Overview ............................................................................................................................................................ 72
9.2 Display ............................................................................................................................................................... 72
9.3 Setting PR Sound ............................................................................................................................................... 72
9.4 Alarm Setup ........................................................................................................................................................72
Chapter 10. SpO2 ................................................................................................................................................... 73
10.1 Overview .......................................................................................................................................................... 73
10.2 Safety Information ........................................................................................................................................... 73
10.3 Monitoring Steps ..............................................................................................................................................74
10.4 Display ............................................................................................................................................................. 75
10.5 Setting SpO2 .................................................................................................................................................... 76
10.5.1 Setting Wave Speed ...............................................................................................................................76
10.5.2 Setting Wave Mode ............................................................................................................................... 76
10.5.3 Setting Average Time ............................................................................................................................ 77
10.6 Measuring Influencing Factors ........................................................................................................................ 77
10.7 Alarm Setup ......................................................................................................................................................78
10.8 Masimo Information ........................................................................................................ 错误！未定义书签。
Chapter 11. NIBP ................................................................................................................................................... 83
11.1 Overview .......................................................................................................................................................... 83
11.2 Safety Information ............................................................................................................................................83
11.3 Measurement Limits .........................................................................................................................................84

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11.4 Measurement Procedure ...................................................................................................................................85

11.4.1 Preparing for Measurement ...................................................................................................................85
11.4.2 Patient posture requirements during measurement ...............................................................................86
11.4.3 Starting / Stopping Measurement ..........................................................................................................86
11.4.4 Correcting Measurement Results ..........................................................................................................86
11.5 NIBP Display ....................................................................................................................................................86
11.6 Setting Inflation Pressure ................................................................................................................................. 87
11.7 NIBP Resetting .................................................................................................................................................87
11.8 NIBP Leakage Test ...........................................................................................................................................87
11.9 NIBP Calibration ..............................................................................................................................................88
11.10 Clean and disinfection method of NIBP cuff .................................................................................................88
11.10.1 Cleaning Method: ................................................................................................................................88
11.10.2 Disinfection Method ........................................................................................................................... 89
11.11 Alarm Setup .................................................................................................................................................... 89
Chapter 12. Temp ...................................................................................................................................................90
12.1 Overview .......................................................................................................................................................... 90
12.2 Safety Information ........................................................................................................................................... 90
12.3 Measurement Steps .......................................................................................................................................... 90
12.4 Measuring Requirements ................................................................................................................................. 90
12.5 Temp Display ................................................................................................................................................... 91
12.6 Selecting Resistance Type of Temp Probe .......................................................................................................91
12.7 Setting Temperature Unit ................................................................................................................................. 91
12.8 Alarm Setup ......................................................................................................................................................92
Chapter 13. Review ................................................................................................................................................93
13.1 Reviewing Trend Chart .................................................................................................................................... 93
13.2 Reviewing Trend Table .................................................................................................................................... 94
13.3 NIBP Measurement Review .............................................................................................................................95
13.4 Event Review ................................................................................................................................................... 96
Chapter 14. CO2 ..................................................................................................................................................... 98
14.1 Introduction ...................................................................................................................................................... 98
14.2 Preparing to Measure CO2 ............................................................................................................................... 99
14.2.1 Using a Sidestream CO2 Module .................................................................................................................. 99
14.2.2 Using a Mainstream CO2 Module .......................................................................................................100
14.3 CO2 Settings ................................................................................................................................................... 102
14.4CO2 Alarm limit settings .................................................................................................................................103
14.5 Measurement limitations ................................................................................................................................103
14.6 Zeroing the Sensor ......................................................................................................................................... 103
14.7 Notice ............................................................................................................................................................. 104
14.8 Cleaning ......................................................................................................................................................... 104
Chapter 15. Recording (Optional) ........................................................................................................................106
15.1 Recorder Profile ............................................................................................................................................. 106
15.2 Loading Paper ................................................................................................................................................ 106

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15.3 Setting up the Recorder ..................................................................................................................................107

15.4 Clearing Recorder .......................................................................................................................................... 108
Chapter 16. Battery .............................................................................................................................................. 108
16.1 Checking Battery Performance ...................................................................................................................... 108
16.2 Overview ........................................................................................................................................................ 109
16.3 Installing the battery .......................................................................................................................................109
16.4 Battery Usage Guide ...................................................................................................................................... 109
16.5 Battery Recycling ............................................................................................................ 错误！未定义书签。
Chapter 17. Cleaning and Disinfection ................................................................................................................ 111
17.1 Cleaning and disinfection safety information ................................................................................................111
17.2 Approved detergents and disinfectants .......................................................................................................... 111
17.3Methods for Cleaning and Disinfection ..........................................................................................................112
17.4 Environmental protection, safe disposal ........................................................................................................114
Chapter 18. Maintenance ..................................................................................................................................... 115
18.1 Checking ........................................................................................................................................................ 115
18.2 Viewing Software Version Info ......................................................................................................................116
18.3 Maintenance Plan ...........................................................................................................................................116
18.4 ECG Calibration .............................................................................................................................................116
18.5 Touch Screen Calibration ...............................................................................................................................117
18.6 CO2 Calibration ..............................................................................................................................................117
18.7 CO2 alarm test ................................................................................................................................................ 118
Chapter 19. Accessories ....................................................................................................................................... 119
19.1 Standard Accessory List .................................................................................................................................119
Chapter 20. Maintenance ..................................................................................................................................... 121
20.1 Maintenance Introduction .............................................................................................................................. 121
20.2 Maintenance Safety Information ................................................................................................................... 121
20.3 Maintenance and Testing Schedule ................................................................................................................122
20.4 Testing Methods and Procedures ................................................................................................................... 122
Chapter 21. Cybersecurity ....................................................................................................................................124
21.1 Testing Methods and Procedures ................................................................................................................... 124
Therefore, for our products, we propose the following countermeasures as a way to improve the cybersecurity of
our products. .........................................................................................................................................................124

Appendix A Specifications .................................................................................................................................. 128

A.1 Safety Specifications .......................................................................................................................................128
A.1.1 Product Category ..................................................................................................................................128
A.1.2 Power Specifications ............................................................................................................................128
A.2 Hardware Specifications ................................................................................................................................. 129
A.2.1 Physical Specifications ........................................................................................................................ 129
A.2.2 Display ................................................................................................................................................. 129
A.2.3 Host LED ............................................................................................................................................. 129

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A.2.4 Audio Instruction ..................................................................................................................................130

A.2.5 Alarm Signal .........................................................................................................................................130
A.3 Data Storage .................................................................................................................................................... 130
A.4 Measurement Specifications ........................................................................................................................... 131
A.4.1 ECG/TEMP/RESP Specifications ....................................................................................................... 131
A.4.2 NIBP Specifications ............................................................................................................................. 132
A.4.3 SpO2 Specifications .............................................................................................................................133
A.4.4 CO2 Specification .................................................................................................................................134
Sidestream CO2 module: ................................................................................................................................134
Mainstream CO2 module: .............................................................................................................................. 138
Appendix B EMC .................................................................................................................................................142

Appendix C Alarm Information ........................................................................................................................... 146

C.1 Physiological Alarm Information ....................................................................................................................146
C.2 Technical Alarm Information .......................................................................................................................... 149
Appendix D Default Parameter Configuration .................................................................................................... 153

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Chapter 1. Safety
1.1 Safety Information

DANGERE

 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.

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 Before operating, the user must check if the device, cables and accessories are functioning properly and safely.
 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 Northern.

 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 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
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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

NOTE

 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).

Power on / off Signal input and output interface

AC power supply (AC) Display Interface

Battery operating indicator Equipotential terminal

Alarm silence Serial Number

NIBP Production date

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Wave freezing Manufacturer info

Waste Electrical and Electronic Equipment

Print
Directive

Refer to the Operator’s Manual EU representative

Manufacturer’s declaration of product

compliance with applicable EEC directives Importer
and the Notified Body reference number

Medical device Unique device identifier

Gas outlet

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Chapter 2. Monitor Overview

2.1 Introduction

2.1.1 Intended Use

The multi-Parameter Patient Monitor is intended use for monitoring, displaying and alarming of more than one vital
physiological including ECG, respiration (RESP), pulse rate (PR), blood oxygen saturation (SPO2), noninvasive
blood pressure (NIBP), temperature (TEMP), carbon dioxide (CO2) of a single patient for adult and pediatric in
hospital.

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 uses electrodes and sensors to collect human ECG, blood pressure, respiration, oxygen
saturation and other physiological parameter signals, and convert these signals into electrical signals，to display
patient data and waveforms, to store patient data in a trend database, and to generate alarms and recordings. Patient
Monitor can monitor the important physiological parameters of the single adult and pediatric patient in hospital
accurately and ensure that a patient’s condition can be evaluated over time and any deterioration identified quickly,
enabling appropriate care to be instituted.

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2.2 Master Unit

2.2.1 Front View

Fig. 2-1 Front View (Aries)

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Fig. 2-2 Front View (Venus/Gemini)

Fig. 2-3 Front View (Taurus/Pisces/Virgo)

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 (Aquarius)

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.
5. Freeze key or print key(⑤):

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 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 (Venus/Aries/Gemini/Taurus/Pisces/Virgo)

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 (Aquarius)

1. Temp ——Temperature probe interface（①）

2. ECG —— ECG cable interface（②）

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

4. NIBP —— NIBP cuff interface（④）

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

2.2.3 Rear View

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Fig. 2-7 Rear View (Venus/Aries/Gemini)

Fig. 2-8 Rear View (Taurus/Pisces/Virgo)

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
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.

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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 (Aquarius)

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.
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. Speaker holes
7. Spiracle

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(Venus, Taurus, Pisces, Virgo,Aries,Gemini))

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:
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 ECG parameter area

 NIBP parameter area
 SPO2 and PR parameter area
 TEMP parameter area
 RESP parameter area
3. Introduction of wave area (3)
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 (Aquarius))

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)

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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. 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

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[Event]: Manual event

[Print]: Print key

[Switch]: Interface switch key

[Freeze]: Freeze key

[Ala.Set]: Alarm setting key

[Silence]: Silence key

[Review]: Review key

[Vol.Set]: Volume setting key

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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 Northern.
 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 Northern. 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.

3.1.2 Environmental Requirements

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

Working Ambient temperature range 5℃~40℃

environment Relative humidity range ≤85%

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Atmospheric pressure range 70kPa~106kPa

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.

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
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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 Northern 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 monitor makes a “tick”
sound, the warning system of the monitor can work normally.

NOTE
 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.

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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.

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

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

Model:Gemini/Aries/Venus/Taurus/Pisces.

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.

Model: Virgo/Aquarius.

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 sub menu.

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 Confirmation key area: Some menus contain a confirmation key area to confirm the menu operations, including
confirmation and cancel key.

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 waves of different parameters as needed.

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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;

 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.
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[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 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

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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.

Fig. 4-1 Patient Info Setting

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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.
 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:

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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.

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.
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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.

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 3-Lead Half-Screen”,
and “ECG 5-Lead Half-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 3-Lead Half-Screen]: ECG 3-lead half-screen.
[ECG 7-Lead Full-Screen]: ECG 5-lead half-Screen
[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-3 Lead Half-Screen

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

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ECG 3-Lead Half-Screen allows observing all parameters, seven ECG waves (I, II, III), one blood oxygen binding
capacity scan wave, and one respiratory wave.

5.2.4 ECG 5-Lead Half-Screen

Fig. 5-4 ECG 5-Lead Half-Screen

ECG 5-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.

5.2.5 OxyCRG Screen

The Respiratory Oxygenation graph screen is shown below

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Fig. 5-7 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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5.2.6 DynaTrend Screen

The DynaTrend screen is shown below:

Fig. 5-8 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 messages generally appear in the technical alarm area and parameters
area.
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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
 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

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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: *

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:

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 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;

 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.

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 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] 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

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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
[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.
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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.
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:

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 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.

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.

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.

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.

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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.

 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
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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.

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.

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

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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

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.

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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.

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.

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

NOTE
 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

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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.

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.

7.6 ECG Setup

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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
 [Strong]: Strong filter mode

 Select [Draw Wave], and set the wave drawing method as below:
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 [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.

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.

8.4 Resp Display

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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

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
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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 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.

 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.
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 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.

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.

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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
8. Source of PR

SpO2 wave is shown in Fig. 10-3.

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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

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.

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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:

 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).

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 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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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.
 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
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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.

 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.

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 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.

NOTE

 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, 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

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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.

 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.

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 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.

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

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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 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.

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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 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

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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.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

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

11.10.1Cleaning 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.

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11.10.2Disinfection 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.

WARNING

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 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.

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].

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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.

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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.
 [1min]: observe the trend of the last 120 hour at 1min interval.

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 [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:

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

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 [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 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:

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 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 1000 events in total, including the physiological
alarm events, technical alarm events and manual events.

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

 [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.
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 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.

NOTE
 The system can store up to 1000 records of Event Logbook. When a new event occurs after 1000 events are
already stored, the new event overwrites the earliest one.
 The alarm log cannot be maintained after power failure, and the time of power failure cannot be captured by the
alarm log.
 If both AC power and battery are powered off more than 20s, the alarm logs will be lost.

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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 (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.
CO2 module accessories:
Airway adapter:Airway adapteris is not in direct contact with the patient,it is for intubated patients.Type:Adult and
pediatric patients.
NomoLine sampling lines: NomoLine sampling lines is not in direct contact with the patient, it is include nasal and
nasal/oral cannulas for non-intubated patients with and without supplementary oxygen delivery and airway adapter
sets for intubated patients.NomoLine sampling lines use for adult and pediatric patients.

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
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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.

NOTE

 When AC interruption is automatically switched to internal battery power supply, RGM operation is not affected
and can still be monitored normally; If the battery power is low, the RGM monitoring value is "?", Check the
AC power and connect it normally.
 Connect the gas sample exhaust port on the rear of NomoLine ISO CO2 to a scavenging system, if intended to
be used in combination with N2O and/or anesthetic agents.

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.
 Do not re-use disposable single-patient use NomoLine family sampling lines due to the risk of cross
contamination.

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 Changed Nomoline sample tube every 2 weeks or it displayed “tube stop paged” (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).
 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.

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

 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).
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 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.

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

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 【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.
 【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.

14.4CO2 Alarm limit settings

1) Press the [Menu] key-> [Alarm setup] -> [CO2],select [CO2 alarm setup].
2) Set the parameters one by one [Low Limit] and [High Limit] key, after setting the appropriate value, aligned digital
frame click OK again.
3) Alarm switch selection: [on] and [off]. [On] is enabled, [off] for shielding.
4) Adjustable alarm levels, [Mid] and [High].
5) Click [Default] converted to factory default settings.

14.5 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.

14.6 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.

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WARNING

 Incorrectly zero of the probe will cause the false results of the gas degrees.
 ISA sidestream 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.

14.7 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.

14.8 Cleaning

NOTE

 RGM cleaning process comply with ISO ISO 17664 and ISO 14937.

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.

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 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
 3-Lead /5-Lead waveforms recording
 Alarm trigger recording
 Frozen wave recording
 Graphic trends recording
 Tabular trends recording
 NIBP review recording
 Event review recording

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
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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

1. [Types]: normal type .

 Normal type 【conventional】:The waveforms that you need to record can be setup in wave options.
2. 【Trace】:The trace of waveforms can be set up, 3 traces or 2 traces. The wave type can be choose from wave
option.

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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.

Chapter 16. Battery16.1 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.

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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.

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.
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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.

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.

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Chapter 17. Cleaning and Disinfection

ISO 17664 compliance:

The cleaning/disinfection process of the multi-parameter monitor has been tested and complies with EN ISO
17664-2:2021.

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.

17.2 Approved detergents and disinfectants

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

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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.

Recommended
Cleaning method Disinfection method
Parts frequency
Interval

the exterior surface , Each patient Wipe: wipe with a damp Wipe: wipe with a damp cloth
cloth immersed in immersed in medium- or
the plugs
alkalescent detergent high-efficiency disinfectant and then
housing ,the keys, (soapy water, etc.) or wipe off the
movable alcohol solution, and then remaining disinfectant with a dry lint

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handle ,battery wipe off the remaining free cloth.

detergent with a dry Dry: dry thoroughly with a dry,
cover and other
lint-free cloth. lint-free cloth and let air dry for at
non-applied parts. NOTE:Any contact of least 30 minutes.Drying times may
detergents with metal parts vary based on the environmental
may cause corrosion.Do not conditions.
damage or bend connector NOTE:Any contact of disinfectant
pins when cleaning. solutions with metal parts may cause
Do not let fluid pool around corrosion.
connection pins. If this Do not damage or bend connector
happens, blot dry with a pins when disinfection or drying.
cotton swab or soft cloth. 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 the display
soapy water, and then wipe
off the remaining detergent 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.

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.

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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 methods provided by the
NIBP Cuff tube,NIBP 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 concerning disposal of the equipment,
please contact Northern Meditec Limited.
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.

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.

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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.

The software version of the monitor: V00.01.25

18.3 Maintenance Plan

The following tasks can only be done by qualified service personnel of Northern. 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 IEC At least once every two years, after replacing the power supply or the monitor
60601-1 falls down.

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

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

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 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.

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.

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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).
4. 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.
5. when the measured CO2 concentration gets stable, lick the【CO2 Maintenance】-【CO2 Calibration】button.
6. 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.

18.7 CO2 alarm test

1. Press the【Menu】key ->【Alarm Setup】interface->【CO2】, select【CO2 Alarm setup】options, select【EtCO2

Low Limit 】 : If set value greater than monitoring value,observe the screen physiological alarm, alarm trigger
【EtCO2 Too Low】.Otherwise, the alarm trigger【EtCO2 too low】disappeared.
2. Press the【Menu】key ->【Alarm Setup】interface->【CO2】, select【CO2 Alarm setup】options, select【EtCO2
High Limit 】 : If set value less than monitoring value,observe the screen physiological alarm, alarm trigger
【EtCO2 Too High】.Otherwise, the alarm trigger【EtCO2 too High】disappeared.
3. Press the【Menu】key ->【Alarm Setup】interface->【CO2】, select【CO2 Alarm setup】options, select【FiCO2
High Limit 】 : If set value less than monitoring value,observe the screen physiological alarm, alarm trigger
【FiCO2 Too High】.Otherwise, the alarm trigger【FiCO2 too High】disappeared.

4. Press the【Menu】key ->【Alarm Setup】interface->【CO2】, select【CO2 Alarm setup】options, select【awRR

Low Limit 】 : If set value greater than monitoring value,observe the screen physiological alarm, alarm trigger
【awRR Too Low】.Otherwise, the alarm trigger【awRR too low】disappeared.
5. Press the【Menu】key ->【Alarm Setup】interface->【CO2】, select【CO2 Alarm setup】options, select【awRR
High Limit 】 : If set value less than monitoring value,observe the screen physiological alarm, alarm trigger
【awRR Too High】.Otherwise, the alarm trigger【awRR too High】disappeared.

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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 Standard Accessory List

Standard accessories are as follows:

Model: Aries,Venus,Gemini,Taurus,Pisces,Virgo,Aquarius；
Parameter configuration：ECG，SPO2，NIBP，TEMP，RESP，CO2
Name
Parts or Specification and
NO. Supplier Material code
accessories model
Shenzhen MED-Link Electronics
1 Lead ECG cable EA050C3I 040.01.000050-00
TECH CO., LTD
Shenzhen MED-Link Electronics
2 Lead ECG cable 040.01.000052-00
EA050C5I TECH CO., LTD
Shenzhen Envisen Industry
3 SpO2 Sensor JSWD001-02 040-000149-00
Co.Limited
AMD-RS-AC323 Shenzhen Envisen Industry
SpO2 Sensor 040-000269-00
2-L Co.Limited
Blood oxygen AMD-RS-AC323
4 Envisen Industry Co.Limited 040-000269-00
saturation probe 2-L
0039PVI blood
Sop2 extended
5 oxygen extension Shenzhen Amydi-med 040.01.000166-00
line
line
Shenzhen MED-Link Electronics
6 TEMP Probe W0001A 040.01.000056-00
TECH CO., LTD
Shenzhen MED-Link Electronics
7 TEMP Probe W0001B 040.01.000057-00
TECH CO., LTD
TEMP Probe Shenzhen MED-Link Electronics
8 W0001C 040.01.000324-00
TECH CO., LTD
9 TEMP Probe CR012-520104 Shenzhen MED-Link Electronics 040.01.000591-00

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TECH CO., LTD

Y000A1 Shenzhen MED-Link Electronics

10 NIBP CUFF 040.01.000010-00
（27cm-35cm） TECH CO., LTD
Y000C1 Shenzhen MED-Link Electronics
11 NIBP CUFF 040.01.000179-00
（14cm-21.5cm） TECH CO., LTD
NIBP Extension CNT03/T/D/T/6*
12 Shenzhen Plinma 040.01.000070-00
tube 3.5 3M Gray
ISA/CAT.NO.441
13 ISA CO2 Masimo Sweden AB 040.01.000034-00
0

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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 Northern.
 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 Northern.

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 1. If you suspect that the measurement values are incorrect.
and calibration 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

20.4 Testing Methods and Procedures

Except the following maintenance tasks, all other test and maintenance tasks should be performed by Northern
qualified service personnel only.
■ Regular check, including visual inspection and power-on test
■ Printer and recorder tests
■ Battery check
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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 occur Control measures
sequences of events
1 Unauthorized access to the U01:Medical personnel do Set IP, gateway and port number by password
system, malicious changes to not have access to patient authorization
the system network physiological monitoring
information, and arbitrary data, which may lead to
setting parameters delayed treatment
U02:The setting is not
reasonable and may lead
to patient death
2 The system software cannot U03:System defect that Installation/upgrade product field service
be upgraded due to the error prevents patients from personnel insert special software to update the
in making the USB flash being treated USB, shutdown and power on, the system
drive 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 work, Restore factory settings by simulating network
product's data, hardware or network communication anomalies
software after it has been fails.
damaged or destroyed.
4 Data Integrity and U05:Medical staff do not Network settings to ensure the connection
Authenticity: The ability of have real-time access to through, run the process deliberately unplug
the product to ensure that data patient monitoring data, the network cable, after a few minutes to
has not been changed in an which may lead to delays connect, check the time and data before
unauthorized manner and in patient care. unplugging, whether the data before
comes from the creator or unplugging automatically uploaded.
provider.
5 The product's ability to H06:System cannot be System software upgrade by password
defend against cyber attacks upgraded authorization
and malware through
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solidification measures.
6 Network IP and port number U08:Medical staff do not 1, quality assurance of the switch, which has
configuration error or switch have access to patient been tested and certified.
equipment problems monitoring data, which 2, reconnect data retransmission mechanism
may lead to delays in
treatment

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Chapter 22. Disposing

It is required that you should not dispose of WEEE as unsorted municipal waste and collect such WEEE separately.

In accordance with Directive 2012/19/EU and national disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed of in a special way within the European Union (EU).
These regulations require the environmentally friendly recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This has been expressed using the icon of the “crossed out
trash can”.

The Multi-Parameter Patient Monitor (Venus, Taurus, Pisces, Virgo,Aries,Gemini,Aquarius) contains batteries and
recyclable electronic waste. To protect the environment, do not dispose of it in household waste as unsorted municipal
waste, but collect separately and take it to an appropriate local collection center.

Before disposing of your Multi-Parameter Patient Monitor (Venus, Taurus, Pisces, Virgo,Aries,Gemini,Aquarius),
please take away the batteries from Multi-Parameter Patient Monitor (Venus, Taurus, Pisces,
Virgo,Aries,Gemini,Aquarius) and dispose of the batteries and Multi-Parameter Patient Monitor (Venus, Taurus,
Pisces, Virgo,Aries,Gemini,Aquarius) separately. Batteries represent a hazard to health and the environment! Never
open, damage, or swallow batteries or allow them to pollute the environment. They may contain toxic, ecologically
hazardous heavy metals.

The removed batteries shall be disposed of at the point of sale or in the corresponding containers provided at
collection points by local public waste authorities and treated according to 2006/66/EC. The batteries and recyclable
electronic waste shall be disposed of in a separate waste container. Packaging materials must be disposed of according
to local regulations. Consult the authorized collection points for more information.

In Germany

For the recyclable electronic waste disposal, you can search the authorized collection points at the following website:
https: //www.ear-system.de/ear-verzeichnis/sammel-und-ruecknahmestellen For batteries, you can search the
authorized collection points at the following website: https:

//www.ear-system.de/ear-verzeichnis/battghersteller#no-back

Search method: using your postcode or the name of the city and state where you live to find collection points near
you.

Other countries

For country-specific information on disposal, contact your local dealers or importer.

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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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Appendix A Specifications

A.1 Safety Specifications

A.1.1 Product Category

In accordance with classification specified in the European Medical Device Regulation（MDR/ REGULATION
(EU) 2017/745）, this monitor is IIb type equipment. The monitor is classified as follows in accordance with IEC
60601-1:

Category Name Specification

Medical Devices IIb

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/TEMP: type CF with defibrillation-proof,

protection grade
NIBP/SpO2: type BF with defirillation-proof.
CO2 module: BF applied part
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，14.8V
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) (Aries)

15.6 inch 398×302×185mm(L×W×T)(Gemini/Venus)
12.1 inch 310×285×166mm (L×W×T)(Taurus/Virgo/Pisces)
8.4inch 175×275×175mm (L×W×T)(Aquarius)
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 (Aries)
15.6 inch 1366×768 pixels (Gemini/Venus)
12.1 inch 800×600 pixels (Taurus/Virgo/Pisces)
8.4inch 600×800 pixels (Aquarius)

A.2.3 Host LED

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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 sound.

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

A.2.5 Alarm Signal

Alarm delay Off or 1s, 2s, 3s, 4s, 5s, 6s, 7s, 8s; depending on the configuration; the default is 4s.
1min, 2min, 3min, 4min, 5min, 10min, 15min or infinite; depending on the
Pause duration
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
3-lead I, II, III
Lead type
5-lead I, II, III, aVR, aVL, aVF, V
Display sensitivity 2.5mm/mV (×0.25), 5mm/mV (×0.5), 10mm/mV (×1.0), 20mm/mV (×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 and 1.2mV
suppression amplitude, the HR calculation won’t be affected
Alarm specifications Range (bpm) Step (bpm)
Adult: 16~300
HR upper limit
Pediatric: 16~350
1
Adult: 15~299
HR lower limit
Pediatric: 15~349
HR
Measuring range 3/5-lead monitoring Adult: 15bpm~300bpm
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Pediatric: 15bpm~350bpm
Resolution 1bpm
Heart rate measurement ±1bpm or ±1%, whichever is greater
error

TEMP
Standards compliant ISO 80601-2-56/EN 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
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
Wave gain ×0.25, ×0.5, ×1, ×2
Scan speed 6.25mm/s, 12.5 mm/s, 25mm/s
Measurement range Adult: 0 to 120 rpm
Pediatric: 0 to 150 rpm
Resolution 1rpm
Accuracy 15rpm-120rpm , ±2 rpm or ±2%, whichever is greater
15rpm＜ or ＞ 120 rpm , not specified

A.4.2 NIBP Specifications

Standards compliant EN 80601-2-30/IEC 80601-2-30, EN/IEC 60601-1.

Measurement method Automatic oscillometric method
Operating mode Manual, automatic, continuous
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Useful life 100, 000 times

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

A.4.3 SpO2 Specifications

Standards compliant ISO 80601-2-61/EN ISO 80601-2-61

Display range 0%~100%
Parameter monitoring Perfusion Index(PI) and Pleth Variability Index(PVI)
SpO2 display resolution 1%
SpO2 checking accuracy 2% (70%~100%); not define when lower than 70%
Upper alarm limit 1%~100%
SpO2 alarm preset limits
Lower alarm limit 0%~99%
SpO2 alarm preset accuracy ±1%
SpO2 alerting signal generates a No delay
delay
SpO2 value refresh period 1s/time
SpO2 value refresh delay ＜10s

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Low sensitivity 7～8s

Average period Intermediate sensitivity 4～6s
Advanced sensitivity 2～3s
Low sensitivity ＜8s
Alarm condition delay period Intermediate sensitivity ＜6s
Advanced sensitivity ＜3s
Alarm sign generates delay period 0s
PR
Measuring range 30~254bpm
Resolution 1%
Accuracy ±2% or ±2bpm
Adult: 16 to 300 bpm
PR high
Pediatric:16-350 bpm
Adult: 15 to 299 bpm
PR Low
Pediatric:15 to 349 bpm

A.4.4 CO2 Specification

Sidestream CO2 module:

General specifications
Description Compact, low-flow sidestream gas analyzers with integrated pump and flow
controller.
Dimensions 91 mm x 60 mm x 37 mm (3.6 x 2.4 x 1.4)
Mechanical interface 4 threaded holes for M2 bolts
Pneumatic interface NomoLine gas inlet
Evac connector intended for 1.6. mm ID tubing
Weight ≤ 130 g
Operating temperature 0 to 50 °C (32 to 122 °F)
Transient operating Temperature The device operates according to specification when exposed to
-20°C to 0°C (-4°F to 32°F) for 20 minutes.
Storage/transport temperature −40 to 70 °C (−40 to 158 °F)
Warm up time after storage at −40°C A warm up period of 10 minutes is required for the NomoLine ISA CO2 system
to fulfill the accuracy specification if immediately put into use after being stored
at −40 °C3)
Operating humidity4) 10% to 95% RH (non-condensing)
Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature)
Operating atmospheric pressure 525 to 1200 hPa (52.5 kPa to 120 kPa)
(corresponding to a max altitude of 5211 m / 17100 feet)
Storage/transport atmospheric 200 to 1200 hPa (20 kPa to 120 kPa)
pressure (corresponding to a max altitude of 11760 m / 38 600 feet)

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Ambient CO2 ≤ 800 ppm (0.08 vol%)

Mechanical robustness Meets the shock and vibration requirements for transport of EN ISO
80601-2-55:2018 clause 201.15.3.5.101.2 and EN 60601-1-12: 2015 clause
10.1.3
Power supply 4.5 to 5.5 VDC,
≤ 0.9 W (normal operation @ 5V)
< 4W (power surge @ 5V can last up to 60 ms when entering measurement
mode from sleep mode or during start-up)
Recovery time after defibrillator test Unaffected
Interface RS-232
Water handling NomoLine Family sampling lines with proprietary water removal tubing.

Sampling flow rate1)2) 50 ± 10 sml/min

Water ingress protection3) The NomoLine gas inlet provide a watertight seal making it possible to use
NomoLine ISA Capno built-in module in IPX5 rated instruments
Particulate and water ingress The NomoLine ISA CO2 Sidestream Gas Analyzer is IPX4 rated.
protection5)
Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature)
Operating atmospheric pressure 525 to 1200 hPa (52.5 kPa to 120 kPa)
(corresponding to a max altitude of 5211 m / 17100 feet)
Storage/transport atmospheric 200 to 1200 hPa (20 kPa to 120 kPa)
pressure (corresponding to a max altitude of 11760 m / 38 600 feet)
Ambient CO2 ≤ 800 ppm (0.08 vol%)
Mechanical robustness Meets the shock and vibration requirements for transport of EN ISO
80601-2-55:2018 clause 201.15.3.5.101.2 and EN 60601-1-12: 2015 clause
10.1.3
Power supply 4.5 to 5.5 VDC,
≤ 0.9 W (normal operation @ 5V)
< 4W (power surge @ 5V can last up to 60 ms when entering measurement
mode from sleep mode or during start-up)
Recovery time after defibrillator test Unaffected
Drift of measurement accuracy ±(0,43 % + 8 % of gas level)
1) Neonatal population is only cleared in limited markets.
2) Excluding cable, tubing and NomoLine.
3) A power on reset is required if a hardware error is generated during the warm up period after being stored at −40°C
4) Not requiring partial pressure greater than 50 hPa, in accordance to IEC 60601-1-12.

Data output
Breath detection Adaptive threshold, minimum 1 vol% change in CO2 concentration.
Respiration rate 4)
0 to 150 ± 1 breaths/min
Fi and ET5) FiCO2 and EtCO2 are displayed after one breath and have a continuously
updated breath average.

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The following method is used to calculate end-tidal (ET) values:

- The highest concentration of CO2 during one breathing cycle with a
weight function applied to favor values closer to the end of the cycle.

EtCO2 will typically decrease below nominal value (ETnom ) when

respiration rate (RR) exceeds the RR threshold (RRth) according to the
following formula:

(with NomoLine HH Adult/Pediatric Airway Adapter Set - REF 3827)

Diagnostic parameters Atmospheric pressure, Cuvette pressure Serial number Software revision
Hardware revision
Flags Breath detected
No breaths detected Check sampling line Unspecified accuracy Sensor error
1) Volumetric flow rate of air corrected to standardized conditions of temperature and pressure.
2) Flow accuracy specification for the extended temperature range (-20 to 0°C) is +15/-10 sml/min.
3) Allow the unit to sample air for at least 20 minutes if an alarm message is displayed after exposure to water.
4) Measured at I/E ratio 1:1 using breath simulator according to EN ISO 80601-2-55 fig. 201.101.
5) Measured according to EN ISO 80601-2-55.

Gas Analyzer
Sensor head Dual channel NDIR type gas analyzer measuring at 3.5 to 4.5 µm. Data
acquisition rate 10 kHz (sample rate 20 Hz / channel)
Compensations Automatic compensation for pressure and temperature. Manual compensation
for broadening effects on CO2.
Calibration No span calibration is required.
Total system response time < 5s
10% to 90% rise time ≤ 400 ms
Warm-up time < 10 seconds (Concentrations reported and full accuracy)
CO2 Rise time1) at 50 sml/min ≤ 300 ms
sample flow
Accuracy – standard conditions
Gas Range2) Accuracy

CO2 0 to 15 vol% ±(0.2 vol% + 2% ofreading) Unspecified

15 to 25 vol%

1)Measured according to EN ISO80601-2-55.

2)All gas concentrations are reported in units of volume percent and may be translated into mmHg or kPa by using the reported
atmospheric pressure.

Accuracy – all conditions

Gas Accuracy

CO2 ±(0.3 kPa + 4% of reading)

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Alarm upper and lower limit setting

Range Resolution
FiCO2 alarm upper limit 0 to 150mmHg 1mmHg
EtCO2 alarm lower limit 0 to 149mmHg 1mmHg
EtCO2 alarm upper limit 0 to 150mmHg 1mmHg
awRR alarm low limit 0 to 119bpm 1bpm
awRR alarm upper limit 1 to 120bpm 1bpm
Effects from water vapor partial pressure on gas readings
When the breathing gas flows through the sampling line, the gas temperature will adapt to the ambient
temperature before reaching the gas analyzer. The CO2 measurement will always show the actual partial
pressure at the current humidity level in the gas sample. As the NomoLine sampling line removes all
condensed water, no water will reach NomoLine ISA CO2 system However at an ambient temperature of
37 °C and a breathing gas with a relative humidity of 95% the CO2 reading will typically be 6% lower than
corresponding partial pressure after removal of all water.
Interfering gas effects

Gas Gas level Effects on CO2

N2O1) 60 vol% - 2)

HAL2) 4 vol% - 3)

ENF, ISO, SEV2) 5 vol% +8% of reading4)

DES2) 15 vol% +12% of reading5)
Xe (Xenon)2) 80 vol% −10% of reading5)
He (Helium)2) 50 vol% −6% of reading5)
Metered dose inhaler propellants2) Not for use with metered dose inhaler
propellants
C2H5OH (Ethanol)2) 0.3 vol% – 4)

C3H7OH (Isopropanol)2) 0.5 vol% – 4)

CH3COCH3 (Acetone)2) 1 vol% – 4)

CH4 (Methane)2) 3 vol% – 4)

CO (Carbon monoxide)6) 1 vol% – 4)

NO (Nitrogen monoxide)6) 0.02 vol% – 4)

O25) 100 vol% – 3)

1) According to the EN ISO 80601-2-55 standard.

2) Negligible interference with N2O / O2 concentrations correctly set, effect included in the specification
“Accuracy, all conditions” above.
3) Negligible interference, effect included in the specification “Accuracy, all conditions” above.
4) Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings
by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual
measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.

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5) In addition to the EN ISO 80601-2-55:2011 standard.

Mainstream CO2 module:

General specifications
Description Extremely compact infrared mainstream multi-gas probe available in two
parameter configurations
Dimensions 38 mm x 37 mm x 34 mm (1.49 x 1.45 x 1.34)
Cable length
2.5m±0.1m

Weight <25g (cable exclude)

Operating temperature 0 to 40 °C (32 to 104 °F)
Storage/transport temperature -40°C to 75°C (-40°F to 167°F)
Operating humidity 4)
10% to 95% RH (non-condensing)
Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature)
Operating atmospheric pressure 525 to 1200 hPa (52.5 kPa to 120 kPa)
(corresponding to a max altitude of 5211 m / 17100 feet)
Storage/transport atmospheric 200 to 1200 hPa (20 kPa to 120 kPa)
pressure (corresponding to a max altitude of 11760 m / 38 600 feet)
Ambient CO2 ≤ 800 ppm (0.08 vol%)
Mechanical robustness Meets the shock and vibration requirements for transport of EN ISO
80601-2-55:2018 clause 201.15.3.5.101.2 and EN 60601-1-12: 2015 clause
10.1.3
Power supply 4.5 to 5.5 VDC,
≤ 0.9 W (normal operation @ 5V)
< 4W (power surge @ 5V can last up to 60 ms when entering measurement
mode from sleep mode or during start-up)
Recovery time after defibrillator test Unaffected
Interface RS-232
Water handling NomoLine Family sampling lines with proprietary water removal tubing.

Sampling flow rate1)2) 50 ± 10 sml/min

Water ingress protection3) The NomoLine gas inlet provide a watertight seal making it possible to use
NomoLine ISA Capno built-in module in IPX5 rated instruments
Particulate and water ingress The NomoLine ISA CO2 Sidestream Gas Analyzer is IPX4 rated.
protection5)
Storage/transport humidity 10% to 95% RH (non-condensing at ambient temperature)
Operating atmospheric pressure 525 to 1200 hPa (52.5 kPa to 120 kPa)
(corresponding to a max altitude of 5211 m / 17100 feet)
Storage/transport atmospheric 200 to 1200 hPa (20 kPa to 120 kPa)
pressure (corresponding to a max altitude of 11760 m / 38 600 feet)
Ambient CO2 ≤ 800 ppm (0.08 vol%)
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Mechanical robustness Meets the shock and vibration requirements for transport of EN ISO
80601-2-55:2018 clause 201.15.3.5.101.2 and EN 60601-1-
12: 2015 clause 10.1.3
Power supply 4.5 to 5.5 VDC,
≤ 0.9 W (normal operation @ 5V)
< 4W (power surge @ 5V can last up to 60 ms when entering measurement
mode from sleep mode or during start-up)
Recovery time after defibrillator test Unaffected
Drift of measurement accuracy ±(0,43 % + 8 % of gas level)
1) Neonatal population is only cleared in limited markets.
2) Excluding cable, tubing and NomoLine.
3) A power on reset is required if a hardware error is generated during the warm up period after being stored at −40 °C
4) Not requiring partial pressure greater than 50 hPa, in accordance to IEC 60601-1-12.

Data output
Breath detection Adaptive threshold, minimum 1 vol% change in CO2 concentration.
Respiration rate 4)
0 to 150 ± 1 breaths/min
Fi and ET 5)
FiCO2 and EtCO2 are displayed after one breath and have a continuously
updated breath average.

The following method is used to calculate end-tidal (ET) values:

- The highest concentration of CO2 during one breathing cycle with a
weight function applied to favor values closer to the end of the cycle.

EtCO2 will typically decrease below nominal value (ETnom ) when

respiration rate (RR) exceeds the RR threshold (RRth) according to the
following formula:

Diagnostic parameters Atmospheric pressure, Cuvette pressure Serial number Software revision
Hardware revision
Flags Breath detected
No breaths detected Check sampling line Unspecified accuracy Sensor error
1) Volumetric flow rate of air corrected to standardized conditions of temperature and pressure.
2) Flow accuracy specification for the extended temperature range (-20 to 0°C) is +15/-10 sml/min.
3) Allow the unit to sample air for at least 20 minutes if an alarm message is displayed after exposure to water.
4) Measured at I/E ratio 1:1 using breath simulator according to EN ISO 80601-2-55 fig. 201.101.
5) Measured according to EN ISO 80601-2-55.

Gas Analyzer
Sensor head Dual channel NDIR type gas analyzer measuring at 3.5 to 4.5 µm. Data
acquisition rate 10 kHz (sample rate 20 Hz / channel)
Compensations Automatic compensation for pressure and temperature. Manual
compensation for broadening effects on CO2.
Calibration No span calibration is required.

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Total system response time < 5s

10% to 90% rise time ≤ 400 ms
Warm-up time < 10 seconds (Concentrations reported and full accuracy)
CO2 Rise time1) at 50 sml/min ≤ 300 ms
sample flow
Accuracy – standard conditions
Gas Range2) Accuracy

CO2 0 to 15 vol% ±(0.2 vol% + 2% ofreading)

1)Measured according to EN ISO80601-2-55.

2)All gas concentrations are reported in units of volume percent and may be translated into mmHg or kPa by using the
reported atmospheric pressure.

Accuracy – all conditions

Gas Accuracy

CO2 ±(0.3 kPa + 4% of reading)

Alarm upper and lower limit setting

Range Resolution
FiCO2 alarm upper limit 0 to 150mmHg 1mmHg
EtCO2 alarm lower limit 0 to 149mmHg 1mmHg
EtCO2 alarm upper limit 0 to 150mmHg 1mmHg
awRR alarm low limit 0 to 119bpm 1bpm
awRR alarm upper limit 1 to 120bpm 1bpm
Effects from water vapor partial pressure on gas readings
When the breathing gas flows through the sampling line, the gas temperature will adapt to the ambient
temperature before reaching the gas analyzer. The CO2 measurement will always show the actual
partial pressure at the current humidity level in the gas sample. As the NomoLine sampling line removes
all condensed water, no water will reach NomoLine ISA CO2 system However at an ambient
temperature of 37 °C and a breathing gas with a relative humidity of 95% the CO2 reading will typically
be 6% lower than corresponding partial pressure after removal of all water.
Interfering gas effects

Gas Gas level Effects on CO2

N2O1) 60 vol% - 2)

HAL2) 4 vol% - 3)

ENF, ISO, SEV2) 5 vol% +8% of reading4)

DES2) 15 vol% +12% of reading5)
Xe (Xenon)2) 80 vol% −10% of reading5)
He (Helium)2) 50 vol% −6% of reading5)

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Metered dose inhaler propellants2) Not for use with metered dose inhaler
propellants
C2H5OH (Ethanol)2) 0.3 vol% – 4)

C3H7OH (Isopropanol)2) 0.5 vol% – 4)

CH3COCH3 (Acetone)2) 1 vol% – 4)

CH4 (Methane)2) 3 vol% – 4)

CO (Carbon monoxide)6) 1 vol% – 4)

NO (Nitrogen monoxide)6) 0.02 vol% – 4)

O25) 100 vol% – 3)

1) According to the EN ISO 80601-2-55 standard.

2) Negligible interference with N2O / O2 concentrations correctly set, effect included in the specification
“Accuracy, all conditions” above.
3) Negligible interference, effect included in the specification “Accuracy, all conditions” above.
4) Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings
by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual
measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.
5) In addition to the EN ISO 80601-2-55 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
NOTE
 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 the internal function
CISPR11 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 power supply network
CISPR11 that isn’t connected to residence directly.
Harmonic emission ClassA
IEC 61000-3-2
Voltage fluctuations and Conform
flicker IEC 61000-3-3

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, concrete or ceramic
discharge (ESD) ±15 kV air ±15 kV air tile. If floors are covered with synthetic

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IEC 61000-4-2 material, the relative humidity should be at

least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital environment.
IEC 61000-4-4 ±1 kV I/O for ±1 kV I/O for
input/output lines input/output lines
(>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 be that of a
short in UT) for 0.5 cycle in UT) for 0.5 cycle typical commercial or hospital environment.
interruptions and If the user of our product requires continued
voltage variations 40 % UT (60 % dip 40 % UT (60 % dip operation during power mains interruptions, it
on power supply in UT) for 5 cycles in UT) for 5 cycles is recommended that our product be powered
input lines IEC from an uninterruptible power supply or a
61000-4-11 70 % UT (30 % dip 70 % UT (30 % dip battery.
inUT) for 25 cycles in UT) for 25 cycles

<5 % UT (>95 % dip <5 % UT (>95 % dip

in UT) for 5 s in UT) for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at
(50/60 HZ) levels characteristic of a typical location in a
magnetic field typical commercial or hospital environment.
IEC 61000-4-8
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 � (d－3.5 �)
d－1.2 � (Resp: d－3.5 �) 80 to 800MHz
d－1.2 � 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 � d＝3.5 � d＝[ 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 physiological condition, and check if
M*
HR Too Low the patient 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 physiological condition, and check if
PVCS Too High M*
the patient category and alarm limit settings are appropriate for the
patient.
Asystole H The patient has arrhythmia. Check the patient's condition, electrodes,
VF/VTA H cables and lead wires.

ECG 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*
Pacemaker Not Capture H Pacemaker works abnormally; check the pacemaker.
Pacemaker Not work H
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Source Alarm message L Causes and countermeasures

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

ST-III Too High

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 physiological condition, and
M*
RR Too Low check if the patient category and alarm limit settings are appropriate for
Resp the patient.
The patient's respiratory signal is too weak, and the system can’t
Apnea(RESP) H
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 lower than the
T1 Too Low lower alarm limit. Check the patient's physiological condition, and
T2 Too High 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 physiological condition, and check if
TD Too High
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 physiological condition, and check if
SPO2 Too Low the patient category and alarm limit settings are appropriate for the
patient.
SpO2 M*
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
PR Too Low the patient category and alarm limit settings are appropriate for the
patient.
NIBP signal weak NIBP value is higher than the upper alarm limit or lower than the lower
NIBP NIBP-Sys Too High M* alarm limit. Check the patient's physiological condition, and check if
NIBP-Sys Too Low the patient category and alarm limit settings are appropriate for the

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Source Alarm message L Causes and countermeasures

NIBP-Mean Too High patient.
NIBP-Mean Too Low
NIBP-Dia Too High
IBP Art-Sys too high M* ArtSys value has risen above the high alarm limit or fallen below the
Art-Sys too low M* 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 below the low
CO2 EtCO2 too low M* alarm limit. Check the patient’s condition and check if the patient
category and alarm limit settings are correct.

FiCO2 too high M*

AWRR too high M*
AWRR too low M*
Apnea CO2 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.(more than 30 s after breathing)

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C.2 Technical Alarm Information

Source Alarm message L Causes and countermeasures

Connect to AC power supply, and charge the battery,
System Battery Low H and power with the battery as needed after fully
charged.
ECG ECG Comm. Stop H ECG module failure, or communication failure between
ECG Comm. Error H the module and the host; please restart the device.
ECG Config Error H
ECG Self check Error H
ECG Lead Off M* The electrodes are not connected to the patient firmly or
ECG YY OFF (YY is a lead fall off, or lead wires and the main cable fall off. Check
M*
name) the connection of electrodes and lead wires.
TEMP1 Sensor Off L The temperature sensor falls off from the patient. Check
Temp
TEMP2 Sensor Off L 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 position,
SpO2
SPO2 Search Timeout whether the sensor is damaged or sensor type.
L
Reconnect the sensor or use new sensor.
SPO2 Search Pulse L Sensor signal is poor or too weak. Check the patient's
SPO2 Signal Unstable L condition, and place the sensor in a suitable position. If
SPO2 Failure L the failure persists, replace the sensor.

SPO2 Signal Weak L

SpO2 SPO2 No Cable Connected L No Cable
(Masimo Cable Expired L Cable Life Expired
SpO2 Incompatible Cable L Incompatible Cable
module) Unrecognized Cable Unrecognized Cable
L
Replace cable L Defective Cable/Cable Life Expired
Cable Near Expiration L Cable Life Near Expiration
SPO2 No Sensor Connected L No Sensor Connected

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Source Alarm message L Causes and countermeasures

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

Sensor Initializing L Sensor Initializing

SPO2 Sensor Off Patient L Sensor Off Patient
SPO2 Pulse Search L Pulse Search
SPO2 Interference Detected L Interference Detected
SPO2 Low Perfusion Index L Low Perfusion Index
SPO2 Demo Mode L Demo Mode
Adhesive Life Near Adhesive Life Near Expiration
L
Expiration
Check Sensor Connection L Check Sensor Connection
SpO2 Only Mode SpO2 Only Mode
SPO2 Low Signal IQ L Low Signal IQ
asimoSET Processing Active L MasimoSET Processing Active
SPO2 Too Much Ambient Too Much Ambient Light
L
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 NIBP Self check error H device.

NIBP CFG Error H

NIBP system error H If failure occurs during measurement, the system can’t

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Source Alarm message L Causes and countermeasures

analyze and calculate. Check the patient's condition,
Measurement timeout L check the connections or replace the cuff, and then
re-test.
The used cuff does not match the set patient category.
Cuff type error L
Verify the patient category and replace the cuff.
NIBP cuff isn’t placed or connected properly, or there is
Cuff loose or no cuff L
gas leak.
Cuff leak L Check cuff and inflation tube.
Ambient atmospheric pressure is abnormal. Confirm
that the environment complies with the monitor's
Air pressure error L
specifications, and check whether there are special
reasons affecting ambient pressure.
The measured blood pressure of the patient exceeds the
NIBP over range L
measuring range.
Patient's pulse may be weak or cuff is too loose. Check
NIBP NIBP signal weak L the condition of the patient, and place the cuff in a
suitable position. If the failure persists, replace the cuff.
NIBP signal unstable Excessive movement may result in too much motion
L artifact or interference in the signal during
measurement.
NIBP signal saturated Motion signal amplitude is too large due to movement
L
and other reasons.
NIBP over pressure Cuff overpressure, and gas blockage may occur; check
L
the gas path, and then re-measure.
NIBP module reset error; check the gas path is blocked,
Module reset failed L
and then restart the measurement.

CO2 CO2 communication stop H The CO2 module fails or module and host connection
CO2 communication error H disconnected, reconnect the CO2 module to monitor.
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.
CO2 Sensor error L Check CO2 sensor matched or not.

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CO2 exceed the measurement The measured value exceed the measurement range
L
range. claimed.
Check, remove heat source or waiting for the module to
CO2 sensor high temp L
recover.
An error occurred in the airway pressure. Check the
CO2 Airway high press L patient connection and patient circuit, and then restart
the monitor.
CO2 check Cal L CO2 preform a calibration
CO2 calibration module fails, please make sure the gas
CO2 checking Cal failure L
path etc, to recalibrate.

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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 analysis Off Off
ST segment Alarm level Mid Mid
analysis Alarm record Off Off
Alarm limits -0.2~0.2 on -0.2~0.2 on
ECG Alarm level Mid Mid
Alarm record Off Off
Arrhythmia Alarm limits 0~10 on 0~10 on
analysis Alarm switch On On
ARR alarm
Alarm level Mid Mid
settings
Alarm record Off Off
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
Measurement mode Adult Child
Interval Manual Manual
NIBP
Display color White White
Pre-inflation value 150 100
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
SPO2 Alarm record Off Off
Alarm limits 90~100 on 90~100 on
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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
CO2
Apnea time 20s 20s
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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