NR-TP-0715-008_3.

0_cn

Aquarius®

Vital Sign Patient Monitor

Operator’s Manual

Northern Meditec Limited

NR-TP-0715-008_3.0_cn

Notice
Thanks for purchasing Aquarius® Vital Sign Patient Monitor.

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

Please keep this Manual properly for future reference.

Product Name: Vital Sign Patient Monitor

Model: Aquarius®
Structure and The monitor consists of master unit, display, ECG cable, SpO2

Components: probe, blood pressure cuff, and temperature probe.

Scope of Application: Monitors patient ECG, respiration (RESP), blood oxygen

saturation (SpO2), pulse rate (PR), noninvasive blood pressure

(NIBP), and temperature (TEMP) as well as displays, reviews

and stores the monitoring information.

Manufacturer: Northern Meditec Limited

Registered Address: 4th Floor, Building C, Jin Wei Yuan Industrial Park, Julongshan

Area, Kengzi St, Pingshan District, Shenzhen, P.R.China

Manufacturing Address: 4th Floor, Building C, Jin Wei Yuan Industrial Park, Julongshan

Area, Kengzi St, Pingshan District, Shenzhen, P.R.China

Version: 3.0

Date of Issue: Feb 20, 2019

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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.

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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: 4th Floor, Building C, Jin Wei Yuan Industrial Park, Julongshan Area, Kengzi St,
Pingshan District, Shenzhen, P.R.China

Postal Code: 518118

Website: www.northernmeditec.com

Email: info@northernmeditec.com

Tel: + 86 755 27952733

Fax: +86 755 86528647

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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 AQUARIUS Vital Sign Patient Monitor in details. Before using the product, please
carefully read and understand the contents of this Manual, and abide by the method of
operation stated in this Manual in order to ensure the safety of patients and operators.

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

Object of Application

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

Illustration

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

Convention

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

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

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Content
Chapter1 Safety .............................................................................................................. - 1 -
1.1 Safety Information ................................................................................................- 1 -
1.1.1 Danger ...........................................................................................................- 1 -
1.1.2 Warning .........................................................................................................- 2 -
1.1.3 Caution ..........................................................................................................- 3 -
1.1.4 Note ...............................................................................................................- 3 -
1.2 Symbols .................................................................................................................- 4 -
Chapter2 Installation & Check ....................................................................................... - 5 -
2.1 Unpacking .............................................................................................................- 5 -
2.2 Environmental Requirements ................................................................................- 6 -
2.3 Connecting to AC Power .......................................................................................- 7 -
2.4 Turning On ............................................................................................................- 7 -
2.4.1 Checking the Monitor ...................................................................................- 7 -
2.4.2 Starting the Monitor ......................................................................................- 7 -
2.4.3 Connecting the Sensor...................................................................................- 8 -
2.4.4 Starting Monitoring .......................................................................................- 8 -
2.5 Turning off ............................................................................................................- 8 -
Chapter3 Monitor Overview ........................................................................................ - 10 -
3.1 Introduction ........................................................................................................ - 10 -
3.1.1 Scope of Application .................................................................................. - 10 -
3.1.2 Contraindications ....................................................................................... - 10 -
3.1.3 Composition and Structure ......................................................................... - 10 -
3.2 Master Unit ........................................................................................................ - 11 -
3.2.1 Front View .................................................................................................. - 11 -
3.2.2 Side View ................................................................................................... - 13 -
3.2.3 Rear View ................................................................................................... - 14 -
3.3 Screen Display ................................................................................................... - 15 -
3.4 Smart Hotkeys .................................................................................................... - 16 -
Chapter4 Basic Operation ............................................................................................ - 18 -
4.1 Basic Operation .................................................................................................. - 18 -
4.1.1 Using the shuttle ......................................................................................... - 18 -
4.1.2 Using Keys ................................................................................................. - 18 -
4.1.3 Using the Touch Screen.............................................................................. - 18 -
4.1.4 Using Soft Keyboard .................................................................................. - 19 -
4.1.5 Using Menu ................................................................................................ - 19 -
4.2 User Setup .......................................................................................................... - 20 -
4.2.1 Defining the Monitor.................................................................................. - 20 -
4.2.2 Language Setup .......................................................................................... - 20 -
4.2.3 Date and Time ............................................................................................ - 20 -
4.2.4 Volume Control .......................................................................................... - 21 -

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4.2.5 Setting Parameter Unit ............................................................................... - 21 -

4.2.6 Network Setup............................................................................................ - 22 -
Chapter5 Patient Information Management ................................................................. - 23 -
5.1 Patient Setup Menu ............................................................................................ - 23 -
5.2 Admitting a Patient Quickly............................................................................... - 24 -
5.3 Admitting a Patient ............................................................................................ - 25 -
5.4 Editing Patient Info ............................................................................................ - 26 -
5.5 Discharging a Patient ......................................................................................... - 26 -
Chapter6 User Interface ............................................................................................... - 28 -
6.1 Selecting User Interface ..................................................................................... - 28 -
6.2 Interface Introduction ......................................................................................... - 28 -
6.2.1 Normal Screen............................................................................................ - 28 -
6.2.2 Big Numerics ............................................................................................. - 29 -
6.2.3 ECG 7-Lead Half-Screen ........................................................................... - 30 -
Chapter7 Alarm ............................................................................................................ - 31 -
7.1 Alarm Type......................................................................................................... - 31 -
7.2 Alarm Level ....................................................................................................... - 32 -
7.3 Alarm Mode ....................................................................................................... - 32 -
7.3.1 Light Alarm ................................................................................................ - 33 -
7.3.2 Audible Alarm ............................................................................................ - 33 -
7.3.3 Alarm Info .................................................................................................. - 33 -
7.3.4 Parameter Flashing ..................................................................................... - 34 -
7.4 Alarm States ....................................................................................................... - 34 -
7.4.1 Silence ........................................................................................................ - 34 -
7.4.2 Alarm sound off ......................................................................................... - 34 -
7.4.3 Alarm Pause ............................................................................................... - 35 -
7.4.4 Alarm off .................................................................................................... - 35 -
7.5 Alarm Setup ....................................................................................................... - 36 -
7.5.1 Setting the Alarm Sound ............................................................................ - 36 -
7.5.2 Setting the Alarm Delay Time .................................................................... - 36 -
7.5.3 Setting a Parameter Alarm.......................................................................... - 37 -
7.6 Latch Alarm........................................................................................................ - 38 -
7.7 Manual Event ..................................................................................................... - 39 -
Chapter8 SpO2 ............................................................................................................. - 40 -
8.1 Overview ............................................................................................................ - 40 -
8.2 Safety Information ............................................................................................. - 40 -
8.3 Monitoring Steps ................................................................................................ - 41 -
8.4 Display ............................................................................................................... - 42 -
8.5 SpO2 Setup ........................................................................................................ - 43 -
8.5.1 Wave Speed ................................................................................................ - 44 -
8.5.2 Wave Mode ................................................................................................ - 44 -
8.5.3 Average Time ............................................................................................. - 44 -

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8.5.4 Setting SpO2 Sensitivity ............................................................................ - 45 -

8.6 Influencing Factors............................................................................................. - 45 -
8.7 Masimo Information........................................................................................... - 45 -
Chapter9 PR ................................................................................................................. - 51 -
9.1 Overview ............................................................................................................ - 51 -
9.2 Display ............................................................................................................... - 51 -
9.3 Pulse Vol............................................................................................................. - 51 -
9.4 Alarm Setup ....................................................................................................... - 51 -
Chapter10 NIBP ............................................................................................................. - 52 -
10.1 Overview ............................................................................................................ - 52 -
10.2 Safety Information ............................................................................................. - 53 -
10.3 Measurement Limits........................................................................................... - 54 -
10.4 Measurement Procedure ..................................................................................... - 55 -
10.4.1 Preparing for Measurement ........................................................................ - 55 -
10.4.2 Patient posture requirements ...................................................................... - 55 -
10.4.3 Starting / Stopping Measurement ............................................................... - 56 -
10.4.4 Correcting Measurement Results ............................................................... - 56 -
10.5 NIBP Display ..................................................................................................... - 56 -
10.6 Inflation Pressure ............................................................................................... - 57 -
10.7 Resetting............................................................................................................. - 57 -
10.8 Leakage Test....................................................................................................... - 57 -
10.9 Calibration .......................................................................................................... - 58 -
10.10 Clean and disinfection ........................................................................................ - 58 -
10.10.1 Cleaning ............................................................................................. - 58 -
10.10.2 Disinfection ........................................................................................ - 59 -
10.11 Alarm Setup ....................................................................................................... - 59 -
Chapter11 Temp ............................................................................................................. - 60 -
11.1 Overview ............................................................................................................ - 60 -
11.2 Safety Information ............................................................................................. - 60 -
11.3 Measurement Steps ............................................................................................ - 60 -
11.4 Measuring Requirements ................................................................................... - 60 -
11.5 Temp Display ..................................................................................................... - 61 -
11.6 Selecting Resistance Type of Temp Probe ......................................................... - 61 -
11.7 Setting Temperature Unit ................................................................................... - 62 -
11.8 Alarm Setup ....................................................................................................... - 62 -
11.9 Quick Temp(Optional) ....................................................................................... - 62 -
11.9.1 Quick Temperature Display............................................................................. - 62 -
11.9.2 Accessories list ........................................................................................... - 64 -
Chapter12 ECG .............................................................................................................. - 65 -
12.1 Overview ............................................................................................................ - 65 -
12.2 Safety Information ............................................................................................. - 65 -
12.3 Monitoring Steps ................................................................................................ - 66 -

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12.3.1 Preparation ................................................................................................. - 66 -

12.3.2 Selecting Lead ............................................................................................ - 67 -
12.3.3 Lead Name and Corresponding Color ........................................................ - 67 -
12.3.4 Installing Electrodes ................................................................................... - 68 -
12.3.5 Checking the Pacemaking Status ............................................................... - 69 -
12.4 ECG Display ...................................................................................................... - 70 -
12.5 ECG Setup.......................................................................................................... - 71 -
12.6 Alarm Setup ....................................................................................................... - 72 -
Chapter13 Review .......................................................................................................... - 73 -
13.1 Reviewing Trend Chart ...................................................................................... - 73 -
13.2 Reviewing Trend Table ...................................................................................... - 74 -
13.3 NIBP Measurement Review ............................................................................... - 75 -
13.4 Event Review ..................................................................................................... - 76 -
Chapter14 CO2 (Optional) ............................................................................................. - 78 -
14.1 Introduction ................................................................................................................ - 78 -
14.2 Preparing to Measure CO2 ......................................................................................... - 79 -
14.3 Mainstream................................................................................................................. - 80 -
14.4 CO2 Settings .............................................................................................................. - 82 -
14.5 Measurement limitations ............................................................................................ - 83 -
14.6 Zeroing the Sensor ..................................................................................................... - 83 -
14.7 Notice ......................................................................................................................... - 84 -
14.8 Cleaning ..................................................................................................................... - 84 -
Chapter15 Caring and Cleaning ..................................................................................... - 85 -
15.1 Overview .................................................................................................................... - 85 -
15.2 Cleaning ............................................................................................................. - 85 -
15.3 Disinfection ........................................................................................................ - 86 -
15.4 Sterilization ........................................................................................................ - 87 -
Chapter16 Maintenance.................................................................................................. - 88 -
16.1 Checking ............................................................................................................ - 88 -
16.2 Viewing Software Version Info .......................................................................... - 89 -
16.3 Maintenance Plan ............................................................................................... - 89 -
16.4 ECG Calibration ................................................................................................. - 90 -
16.5 Touch Screen Calibration ................................................................................... - 90 -
Chapter17 Calculate ......................................................................................................... - 92 -
17.1 Overview .................................................................................................................... - 92 -
17.2 Dose Calculation ........................................................................................................ - 92 -
17.2.1 Calculating Step .............................................................................................. - 92 -
17.2.2 Unit of Measurement....................................................................................... - 93 -
17.2.3 Titration Table ................................................................................................. - 93 -
17.3 Oxygenation Calculation............................................................................................ - 94 -
17.3.1 Calculating Step .............................................................................................. - 94 -
17.3.2 Input Parameter ............................................................................................... - 94 -
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17.3.3 Output Parameter ............................................................................................ - 94 -

17.4 Ventilation Calculation ............................................................................................... - 95 -
17.4.1 Calculating Step .............................................................................................. - 95 -
17.4.2 Input Parameter ............................................................................................... - 95 -
17.4.3 Output Parameter ............................................................................................ - 95 -
17.5 Hemodynamic Calculation ......................................................................................... - 96 -
17.5.1 Calculating Step .............................................................................................. - 96 -
17.5.2 Input Parameter ............................................................................................... - 96 -
17.5.3 Output Parameter ............................................................................................ - 96 -
17.6 Renal Function Calculation ........................................................................................ - 97 -
17.6.1 Calculating Step .............................................................................................. - 97 -
17.6.2 Input Parameter ............................................................................................... - 97 -
17.6.3 Output Parameter ............................................................................................ - 98 -
17.7 MEWS System ........................................................................................................... - 98 -
Chapter18 Spot Check .................................................................................................... - 102 -
18.1 Outline...................................................................................................................... - 102 -
18.2 Set Point Measurement ............................................................................................ - 102 -
18.3 Use the Spot Check .................................................................................................. - 102 -
Chapter19 Recording (Optional) .................................................................................... - 106 -
19.1 Recorder Profile ....................................................................................................... - 106 -
19.2 Loading Paper .......................................................................................................... - 107 -
19.3 Setting up the Recorder ............................................................................................ - 107 -
19.4 Clearing Recorder .................................................................................................... - 108 -
Chapter20 Battery.............................................................................................................. - 109 -
20.1 Checking Battery Performance ................................................................................ - 109 -
20.2 Overview .................................................................................................................. - 109 -
20.3 Installing the battery................................................................................................. - 110 -
20.4 Battery Usage Guide ................................................................................................ - 110 -
20.5 Battery Recycling ..................................................................................................... - 111 -
Chapter21 Accessories ................................................................................................... - 112 -
21.1 ECG.......................................................................................................................... - 113 -
21.2 SpO2 ........................................................................................................................ - 113 -
21.3 NIBP ........................................................................................................................ - 114 -
21.4 Temp......................................................................................................................... - 114 -
Appendix A Specifications ................................................................................................ - 115 -
A.1 Safety Specifications ................................................................................................. - 115 -
A.1.1 Product Category ............................................................................................ - 115 -
A.1.2 Power Specifications ...................................................................................... - 115 -
A.2 Hardware Specifications ........................................................................................... - 116 -
A.2.1 Physical Specifications ................................................................................... - 116 -
A.2.2 Display ........................................................................................................... - 116 -
A.2.3 Host LED ....................................................................................................... - 116 -
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A.2.4 Audio Instruction ............................................................................................ - 116 -

A.2.5 Recorder ......................................................................................................... - 116 -
A.2.6 Alarm Signal................................................................................................... - 117 -
A.2.7 Data Storage ........................................................................................................... - 117 -
A.3 Measurement Specifications ..................................................................................... - 118 -
A.3.1 ECG/TEMP/RESP Specifications .................................................................. - 118 -
A.3.2 NIBP Specifications ....................................................................................... - 120 -
A.3.3 SpO2 Specifications ....................................................................................... - 121 -
Appendix B EMC .............................................................................................................. - 123 -

Appendix C Alarm Information ........................................................................................ - 127 -

C.1 Physiological Alarm Information .............................................................................. - 127 -
C.2 Technical Alarm Information..................................................................................... - 130 -
Appendix D Default Parameter Configuration .................................................................. - 134 -

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Chapter1 Safety

1.1 Safety Information

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

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

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

Note

 Emphasize important considerations, and provide a description or explanation

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

1.1.1 Danger

This product does not involve information of danger levels.

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1.1.2 Warning

Warning

 This monitor is used for clinical patient monitoring, and only trained and
qualified doctors and nurses are allowed to use this monitor.
 Before operating, the user must check if the device, cables and accessories are
functioning properly and safely.
 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 inflammables 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.

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 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 and frequency requirements on the equipment
label or in the Operator’s Manual.
 When the instrument and accessories are about to exceed the useful life, it must
be treated in accordance with relevant local laws and regulations or the
hospital's rules and regulations.

1.1.4 Note

Notes

 Install the device at a place easy for observation, operation and maintenance.
 Keep this Manual near the instrument for easy reference.
 The instrument should be used only by one patient at the same time.

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1.2 Symbols

The symbols appearing on the instrument are as follows:

Defibrillation-proof type
EU representative
CF applied part

Defibrillation-proof type
USB interface
BF applied part

Caution: Refer to
accompanying documents Network Interface
(Operator’s Manual).

Signal input and output

Power on / off
interface

Refer to the Operator’s

AC power supply (AC)
Manual

Battery operating indicator Equipotential terminal

Alarm silence Serial Number

NIBP Production date

Wave freezing Manufacturer info

Waste Electrical and

Print Electronic Equipment
Directive

Manufacturer’s declaration of product compliance with applicable EEC

directives and the Notified Body reference number

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Chapter2 Installation & Check

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.

2.1 Unpacking

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

Note

 Please keep the packing box and material for use in future transporting or
storage.
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2.2 Environmental Requirements

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

Working Ambient 5℃~40℃

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

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

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

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

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2.3 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.

2.4 Turning On

2.4.1 Checking the Monitor

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

whether the external cables and accessories are connected correctly.

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

battery is fully charged.

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

works properly.

Warning

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

2.4.2 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

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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.

Notes

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

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

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

2.4.3 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.

2.4.4 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.

2.5 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,
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and the monitor turns off in five seconds.

Caution

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

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Chapter3 Monitor Overview

3.1 Introduction

3.1.1 Scope of Application

This monitor is suitable for bedside monitoring of adults and pediatric. This monitor enables
ECG, respiration (RESP), pulse rate (PR), blood oxygen saturation (SPO2), noninvasive
blood pressure (NIBP), and temperature (TEMP) monitoring. It is equipped with a
replaceable built-in battery to provide convenience for the patient movement in hospital.

3.1.2 Contraindications

None.

3.1.3 Composition and Structure

The monitor consists of master unit, display, ECG cable, SpO2 probe, blood oxygen cuff,
temperature probe, and built-in lithium battery.

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3.2 Master Unit

3.2.1 Front View

Fig. 3-1 Front View

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)

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 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):
 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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3.2.2 Side View

Fig. 3-2 Side View

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).

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3.2.3 Rear View

Fig. 3-3 Rear View (example)

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

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3.3 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 and wave area, ○

3 NIBP list ○
4 Smart hotkey area.

Fig. 3-4 Standard Interface (Demo Mode)

1. Introduction of info area (○

1 )

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

2. Parameter area and wave area (○

2 )

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

measurement value and current upper and lower alarm limits of each parameter module.
The parameters are shown in fixed positions, that is, from top to bottom and from left to
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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 3.4 for details.

3.4 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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Chapter4 Basic Operation

4.1 Basic Operation

4.1.1 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.

4.1.2 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.

4.1.3 Using the Touch Screen

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

4.1.4 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.

4.1.5 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. 4-1 Main Menu

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

4.2.1 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 >>] →enter the password and confirm → [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.

4.2.2 Language Setup

Set the monitor language in the following steps:

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

 Select [User Maintenance >>] →enter the password and confirm → [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.

4.2.3 Date and Time

Set the monitor time in the following steps:

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 Select [Menu] Smart Hotkey→[Main 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.

4.2.4 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.

4.2.5 Setting Parameter Unit

You can select a preferred unit through the following operations

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

 Select [User Maintenance >>] →enter the password and confirm → [User Maintenance]
menu;

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 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.

4.2.6 Network Setup

Press【Main Menu】→【UserMaintenance】→【Network Setup】to connect the monitor with

CMS.

Fig. 4-2 Network Setup

1.Press【Net Type】to choose the network type.

2.Press【IP Add】to set the IP address of the monitor.
3. If the network type is wireless, type then network name in【SSID】and type the password in
【Passwords】and press【OK】key. If the network type is wired, then ignore【SSID】and
【Passwords】

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Chapter5 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.

5.1 Patient Setup Menu

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

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

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

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Fig. 5-1 Patient Setup Menu

5.2 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. 5-2 Quick Admitting Menu

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

 [Adu]: Adults.
 [Ped]: Pediatric.

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5.3 Admitting a Patient

To admit a patient, operate as follows:

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

Fig. 5-3 Patient Info

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

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

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

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

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

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

 [Adu]: Adults.
 [Ped]: Pediatric.
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f) 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.

g) Select [High (cm)], and set the patient’s height via the pop-up keyboard on the
screen.
h) Select [Weight (kg)], and set the patient’s weight via the pop-up keyboard on the
screen.
i) 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.

j) Select [Admit date (yyyy-mm-dd)], and set the date of admitting the patient.
k) 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.

5.4 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.

5.5 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.

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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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Chapter6 User Interface

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

6.1 Selecting User Interface

Select the user interface as follows:

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

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

 [Normal Screen]: Standard interface.

 [Big Numerics]: Big font interface.
 [ECG 7-Lead Half-Screen]: ECG 7-lead half-screen.
 [ECG 7-Lead Full-Screen]: ECG 7-lead full screen.

6.2 Interface Introduction

6.2.1 Normal Screen

The normal screen is as shown in 6-1：

Fig. 6-1 Normal Screen

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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 NIBP, SPO2, TEMP, one blood oxygen binding capacity scan wave.

Press【menu】->【Screen Setup】to setup the parameters shown in the display

6.2.2 Big Numerics

5 The Big Numerics screen is as shown in Fig. 6-2:

Fig. 6-2 Big Numerics Screen

Big Numerics screen allows observing NIBP+SPO2 parameters and one blood oxygen
binding capacity scan wave.

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6.2.3 ECG 7-Lead Half-Screen

ECG 7-Lead Half-Screen

Fig.6-3 ECG 7-Lead Half-Screen

ECG 7-Lead Half-Screen allows observing all parameters, seven ECG waves (I, II, III, AVR, AVL,
AVF, V)

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Chapter7 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
is 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.

7.1 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
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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.

7.2 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.

7.3 Alarm Mode

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

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 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.

7.3.1 Light Alarm

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

 High level alarm: Red, fast flashes

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

7.3.2 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

7.3.3 Alarm Info

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

 High level alarm: Red

 Medium level alarm: Yellow
 Low level alarm: Yellow

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

 High level alarm: ***

 Medium level alarm: **
 Low level alarm: *
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7.3.4 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.

7.4 Alarm States

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

 Alarm silence

 Alarm sound off

 Alarm pause

 Alarm off

7.4.1 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.

7.4.2 Alarm sound off

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

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

 Select [User Maintenance >>] →enter the password and confirm → [User Maintenance]
menu;
 Select [Alarm Param >>] → [Ala.Para Setup] menu;

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 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.

7.4.3 Alarm Pause

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

 Alarm state icon area will display the icon.

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

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

You can set the alarm pause time as follows:

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

 Select [User Maintenance >>] →enter the password and confirm → [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.

7.4.4 Alarm off

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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.

7.5 Alarm Setup

7.5.1 Setting the Alarm Sound

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

7.5.2 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 >>] →enter the password and confirm → [User Maintenance]
menu;
 Select [Alarm Param >>] → [Ala.Param Setup] menu;
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 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.

7.5.3 Setting a Parameter Alarm

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

1. Turn on / off alarm

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

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

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

monitor won’t prompt the parameter alarm.

2. Set the alarm level

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

 [Low]: Set the alarm level to low.

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

3. Set the alarm limit

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

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

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

4. Restore default alarm setup

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 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.

7.6 Latch Alarm

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

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

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

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

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

longer prompt the physiological alarm.

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

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

 Select [User Maintenance >>] →enter the password and confirm → [User Maintenance]
menu;
 Select [Alarm Param >>] → [Ala.Param Setup] menu;
 Select [Latching Alarms], and set the alarm as needed:

 [Latching]: Latching alarm.

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 [No latching]: Non-latching alarm.

7.7 Manual Event

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

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

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

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Chapter8 SpO2

8.1 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.

8.2 Safety Information

Warning

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

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 Before monitoring, check whether the sensor cable is normal. When SPO2 sensor
cable is unplugged from the socket, the screen will display [SPO2Sensor OFF]
error message, and trigger an audible and visual alarm simultaneously.
 If the sensor or sensor packaging has signs of damage, do not use this SPO2 sensor;
return it to the manufacturer.
 If there is carboxyhemoglobin, methemoglobin or dye diluted chemical, the SPO2
value will have deviation.
 When the patient has a tendency to hypoxia, use the oximeter to analyze blood
samples in order to fully grasp the patient's condition.
 Do not put the sensor on limbs with arterial duct or intravenous tube.
 Do not intertwine electrosurgical equipment cable with the sensor cable.
 Avoid using the monitor and sensors while using the NMR equipment, in order to
avoid severe burns to the patient as a result of induced currents.
 During long time continuous monitoring of a patient, check the position of SpO2
sensor once every 2 hours, and move properly when the skin changes or every four
hours. Some patients may require more frequent inspection, such as patients with
perfusion disorders or sensitive skin, because persistent and prolonged monitoring
may increase unpredictable skin changes, such as allergies, redness, blistering or
pressure necrosis.
 Carefully select SpO2 alarm upper limit. High oxygen level will cause crystal-like
fibrous tissue disease to premature children.

Note

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

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

8.3 Monitoring Steps

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

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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 sensor type, sensor mounting position, whether the
sensor is damaged, then reconnect the sensor or use new sensor.

8.4 Display

SpO2 parameter area is shown in Fig. 8-1.

Fig. 8-1 SpO2 Parameter Area

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

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

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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.

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.

8.5 SpO2 Setup

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

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Fig. 8-3 SpO2 Setup Menu

8.5.1 Wave Speed

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

8.5.2 Wave Mode

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

 [Scan]: Scan mode.
 [Fill]: Fill mode.

8.5.3 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].

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8.5.4 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.

8.6 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).
 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 can not 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: 0～45℃, Humidity range:
0~85% (non-condensing), Elevation range: -500m~5000m.

8.7 Masimo Information

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

 Masimo Spo2 product description

The Masimo module is intended to monitor the PR, SpO2, PI of patients. Pulse oximetry is a
continuous and non-invasive method of measuring the level of arterial oxygen saturation in
blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for
adults, and the hand or foot for neonates. The sensor is connected to the pulse oximetry
instrument with a patient cable. The sensor collects signal data from the patient and sends it
to the instrument. The instrument displays the calculated data in three way

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

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

 Masimo Spo2 Operating principals

Pulse oximetry is governed by the following principles

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

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

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

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

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

Warning

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

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 Elevated levels of dyshemoglobin

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

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.

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 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.
 Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently
displayed while monitoring consecutive patients after completing troubleshooting steps listed
in this manual.

Notes

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 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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Chapter9 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 Pulse Vol.

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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Chapter10 NIBP

10.1 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

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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.

10.2 Safety Information

Warning
 Do not carry out non-invasive blood pressure measurement on patients with sickle
cell disease and skin damage or any expected damage.
 For patients with severe coagulation disorder, determine if the automatic blood
pressure measurement is carried out according to the clinical evaluation, since the
friction of body and cuff may produce hematoma.
 When measuring on pediatric and neonate patient, ensure that the correct patient
mode (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, Neonate mode: 150mmHg). Using the wrong patient mode may
endanger the safety of patients because higher adult blood pressure level does not
apply to pediatric and neonate patients.
 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.
 Do not measure blood pressure frequently, otherwise it 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.

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10.3 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.

 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

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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.

10.4 Measurement Procedure

10.4.1 Preparing for Measurement

a) Turn on the monitor, and check if it works properly;

b) Verify the patient mode, and make changes if improper;
c) Connect the blood pressure cuff extension tube to the monitor;
d) 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 %( Neonate 50%) of the limb circumference or 2/3 of the upper
arm length. The length of the inflated part of the cuff should be sufficient for
50%~80% around the limb.
 Place the cuff on the upper arm or thigh of the patient, and ensure that the marking
φ is located just above the appropriate artery. Make sure that the cuff does not wrap
too tight around the limb, or it may cause distal discoloration or even ischemia.

10.4.2 Patient posture requirements

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.

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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.
 Please use neonate cuff to measure on neonate patient.

10.4.3 Starting / Stopping Measurement

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

10.4.4 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.

10.5 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. 10-1 NIBP Parameter Area

10.6 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.

10.7 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.

10.8 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

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

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

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

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

Fig. 10-2 NIBP Leakage Test Connection Diagram

10.9 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.

10.10 Clean and disinfection

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

10.10.1 Cleaning

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
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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 tub

10.10.2 Disinfection

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

10.11 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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Chapter11 Temp

11.1 Overview

This monitor has one temperature measurement channels; the temperature sensor will
measure the body temperature.

11.2 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.

11.3 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.

11.4 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

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minimum measuring time is 1s, and the measuring interval is 1s.

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

11.5 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. 11-1 TEMP Parameter Area

11.6 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.

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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.

11.7 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].

11.8 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.

11.9 Quick Temp(Optional)

11.9.1 Quick Temperature Display

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

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

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Fig. 13-2 Screen Setup Menu

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

Fig. 12-3 QTT Parameter Area

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

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Fig. 12-4 QTT Setup

11.9.2 Accessories list

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

Fig. 12-5 Infrared Ear Thermometer list

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

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Chapter12 ECG

12.1 Overview

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

heart, and displayed with waves and numerics on the monitor in order to accurately assess the
physiological state of the patient at the time. The ECG cable should be connected properly, so
as to obtain a correct measurement value and normal display. This monitor can
simultaneously display 7 ECG waves.

Patient cable consists of two parts:

 Wires connected to the monitor

 ECG device connected to the patient

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

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

All these parameters can be used as alarm parameters.

Note

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

12.2 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
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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).

12.3 Monitoring Steps

12.3.1 Preparation

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

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

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

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

 Install the spring clip or stud prior to the placement of the electrodes.

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 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.

12.3.2 Selecting Lead

 Select the ECG parameter area or wave area → [ECGSetup] menu;

 Select [Other Setup >>] → [ECG Other Setup] menu;
 Select [Lead Type], and select the ECG lead as needed:

 [3-Lead]: 3-lead; ECG wave options: I, II, III.

 [5-Lead]: 5-lead; ECG wave options: I, II, III, AVR, AVL, AVF, V.

12.3.3 Lead Name and Corresponding Color

The lead names in European standard and U.S. standard (represented with R, L, N, F, C in
European Standard, and represented with RA, LA, RL, LL, V in the U.S. standard) are shown
in Chart 12 -1.

Chart 12-1: Lead Name in European Standard and American Standard

European Standard (IEC) American Standard (AHA)

Lead Name Color Lead Name Color

R Red RA White

L Yellow LA Black

F Green LL Red

N Black RL Green

C White V Brown

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12.3.4 Installing Electrodes

 3-lead

The electrode placement position of 3-lead is shown in Fig.12-1:

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

 L electrode: placed below the clavicle, near the left shoulder.
 F electrode: placed on the left abdomen.

Fig. 12-1 3-lead Connection Method

 5-lead

The electrode placement position of 5-lead is shown in Fig. 12-2:

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

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

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Fig. 12-2 European 5-lead Connection Method

Notes

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

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

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

12.3.5 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

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12.4 ECG Display

 ECG wave display

The monitor displays two ECG waves on the normal screen. Fig. 12-3 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. 12-3 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. 12-4:

Fig. 12-4 ECG Parameter in Normal Screen

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12.5 ECG Setup

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

Fig. 12-5 [ECG Setup] Menu

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

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

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

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

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

 [Monitor]: Monitor mode

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

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

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

12.6 Alarm Setup

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

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Chapter13 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.
 [5min]: observe the trend of the last 120 hour at 5min interval.
 [10min]: observe the trend of the last 120 hour at 10min interval.

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 [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.
 [1min]: observe the data of the last 120 hour at 1min interval.
 [5min]: observe the data of the last 120 hour at 5min interval.

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 [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.
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 NIBP viewing method is as follows:

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

and observe more data.

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

observe more data.

13.4 Event Review

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

Fig. 13-4 Event Review

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

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

 [ECG]: View ECG-related alarm events.
 [SPO2]: View SPO2 related alarm events.

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 [NIBP]: View NIBP related alarm events.

 [RESP]: View RESP related alarm events.
 [TEMP]: View TEMP related alarm events.
 [Manual]: View manual events.
 [All]: View all related events.

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

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

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

Fig. 13-5 Waveform Review

 Event viewing method is as follows:

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

and observe more data.

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

observe more data.

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Chapter14 CO2 (Optional)

14.1 Introduction

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

There are two kinds of CO2 measuring module:

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

The measurement provides:

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

Fig. 14.1 CO2 Parameter and waveform

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

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. 14-1 Sidestream CO2 module and Nomoline sample ling

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

WARNING
 Nomoline sample line can’t be reusing, and sample tube can be waste treatment after used according
to the regulations of the local medical rule.

 Changed Nomoline sample tube every 2 weeks or it displayed “tube stoppaged” (Red sampling line).

 Only can use MASIMO produced Nomoline sampling tube, otherwise it will lead to inaccurate
measurements.

 Seriously rationalize sampling tube, to reduce the risk of twisting or bridle patients.

 Please confirm whether the current sampling tube is suitable for the patient, don’t be confused baby
and adult/child tube when connection.

 Check whether sample gas velocity in patients with given category is too high.

 When put ISA CO2 module, should be firmly installed ISA module, avoid to put it in patients on the
location.

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 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.

Chart 14-1 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

14.3 Mainstream

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.

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

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

 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.

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 Avoid CO2 module probe in contact with baby’s body directly when CO2 mainstream module probe
connected to infant circuit.(no matter for any reason to make the CO2 sensor direct contact with any
part of baby’s body ,must be use insulating materials between CO2 and part of body).
 Don’t put IRMA airway adapter between endotracheal tube and elbow, otherwise secreta of patient
will jam the airway adapter and operation mistake.
 Replace adapter if airway adapter in water/water condensation
 Only using made in Masimo IRMA airway adapter.

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

14.4 CO2 Settings

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

Fig. 14-2 CO2 setup menu

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【Apnea time】:The Monitor will alarm if the patient has stopped breathing for longer than the
preset apnea time. Can Setup for：20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s
【Operating Mode】: CO2 module can setup to “Measure” or “Standby”.
Measure：CO2 module can be normal measurement and zeroing etc.
On standby：CO2 module do not work, not accept CO2 measurement, zeroing, calibrating etc.
【O2 Compen】: Can setup for low, medium, high, default value is low.
【N2O Compen】: Can setup for ON, OFF, default value is off.
【Unit】:Use for EtCO2 and FICO2 parameter display, can setup units for mmHg, Kpa, %, Default
value is mmHg.
【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.

14.5 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.

WARNING

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

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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

 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.
 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.
 For the AG module of the IRMA mainstream, it is required to remove the disposable IRMA
airway adapter before cleaning the IRMA probe

Warning

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

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Chapter15 Caring and Cleaning

15.1 Overview

In the using process, please make sure that there is no dust on or near your device. To prevent
damage, please use the diluted detergents and disinfectants specified in this Manual, and use
the lowest possible concentration. For the damage or accident caused by using other materials
or methods, Northern does not assume any responsibility.

15.2 Cleaning

The device should be cleaned regularly. In the heavily polluted environment, increase the
frequency of cleaning. Before cleaning, please consult the hospital about device cleaning
requirements.

Below are available cleaning agents:

 Diluted ammonia
 Diluted sodium hypochlorite (washing bleach)
 Diluted formaldehyde
 Hydrogen peroxide (3%)
 Ethanol (70%)
 Isopropanol (70%)

Before cleaning:
1. Turn off the monitor, disconnect the power cord and remove the battery.
2. Use a soft cotton ball to adsorb appropriate amount of cleaning agent and wipe the
display screen.
3. Use a soft lint-free cloth to adsorb appropriate amount of cleaning agent and wipe the
surface of the device.
4. If necessary, use a clean, dry, lint-free cloth to remove any excess detergent.
5. Dry the device naturally in a ventilated cool environment.

Warning

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 Before cleaning the monitor or sensor, turn off the power and disconnect the AC
power.
 The monitor should be kept clean. It is recommended to regularly clean the
enclosure surface and the display screen. Cleaning the enclosure with non-etching
cleaners such as soap and water.

Caution

 To avoid damaging the monitor:

 Do not use strong solvents such as acetone.
 Most cleaners must be diluted before use. Dilute according to the
manufacturer's instructions.
 Do not use abrasive materials (such as steel wool).
 Do not allow any liquid entering into the enclosure, and never immerse any
part of the device into liquid.
 Do not leave any cleaning solution on the surface of any part of the device.

Notes

 Wipe the monitor and sensor surface with medical alcohol, dry it naturally or with
clean, dry, lint-free cloth.
 Northern is not liable for effectiveness of using these chemicals for infectious
disease control. Please consult the infectious disease control officers or experts of
the hospital for advice.

15.3 Disinfection

In order to avoid damage to the product, we recommend that the product is disinfected only
when it is deemed necessary by the hospital maintenance procedures. We also recommend
that the instrument to be disinfected must first be cleaned.

Caution

 To prevent damage to the monitor, do not disinfect the monitor with gas (EtO) or
formaldehyde.

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15.4 Sterilization

In order to avoid long-term damage to the device, we recommend that the product is
sterilized only when it is deemed necessary by the instrument maintenance program. We also
recommend that the instrument to be sterilized must first be cleaned.

Sterilization materials recommended for the monitor: ethanol group, aldehyde group.

Caution

 Dilute or use concentration as low as possible according to the manufacturer's

instructions.
 Do not let liquid enter into the enclosure.
 Never immerse any part of the instrument.
 Do not pour liquid onto the instrument in the sterilization process.
 Do not leave any fungicide residues on the surface of the device; clean it
immediately with a damp cloth.

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Chapter16 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.

16.1 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.

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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.

16.2 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: V1.1.7

16.3 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.

Chart 16-1 Maintenance Plan

Inspection / Maintenance Item Frequency

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

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

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

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

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16.4 ECG Calibration

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

Prepare the following instruments before testing:

 ECG simulator
 ECG cable
 Vernier caliper

The calibration method is as follows:

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

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

 Select [User Maintenance >>] →enter the password and confirm → [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.

16.5 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 >>] →enter the password and confirm → [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.

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 If the touch screen calibration is finished after clicking three times, select [Ok] to exit
the calibration interface; if the touch screen isn’t completely calibrated, select [Retry]
for re-calibration.

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Chapter17 Calculate

17.1 Overview

This monitor provides computing capabilities, the calculated values are not directly measured
patient data, but the results from the monitor calculated according to the appropriate data you
provide.
The following calculations can be performed on the monitor:

To calculate something, in the main menu, select [calculate], select a different calculation function
to calculate.

Notes

 Calculation is independent of the other features of the monitor, the patient can not object
computing monitor the guardianship. Calculating operation will not affect the care of patients
who are

Warning
 Should be carefully calculated to verify the correctness of input parameters and results of
suitability. The Company does not assume any responsibility for all the consequences of
input and operational errors caused by

17.2 Dose Calculation

17.2.1 Calculating Step

1. In the menu, select [calculate] → [Dose Cal.].

2. Select the type [patient cat.] and [Drug Name]. In [Drug Name] drop-down list on the right, you
can select the required drug name from the following 15 kinds of medicines. Among them, the
name of the drug A, B, C, D, and E can be defined by the user.
Drug A, B, C, D, E
Aminophylline
Dobutamine
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Dopamine
Epinephrine
Heparin
Isuprel
Lidocaine
Nipride
Nitroglycerin
Pitocin
3. After the completion of the previous operation, the system will automatically give a default
value. These data cannot be calculated as a result, they must enter the known, the correct
parameter values according to the doctor's instructions.
4. Enter the weight of the patient.
5. Enter the correct parameter values.
6. Confirm the correctness of the calculation results.

17.2.2 Unit of Measurement

Each drug fixed unit or unit series are calculated. In the same unit in the series, will hexadecimal
parameter values with the input of the unit is automatically adjusted.
Units of various drugs as follows:
Drug A, B, C, aminophylline, dobutamine, dopamine, epinephrine, isoproterenol, lidocaine,
nitroglycerin and sodium nitroprusside, using a series of units: g, mg, mcg.
Drug D, Heparin and oxytocin, the use of series unit: unit, KU, MU.
Drug E use Unit: mEq
When a custom of certain drugs, the operator should be the drug of choice in accordance with
Series A, B, C, D, E.

17.2.3 Titration Table

After completion of the drug calculation, Drug calculation titration table] window, select ["]
to open the titration table.
In the titration table, you can change:



After you change the above options, the titration data in the table will change accordingly.
You can also:

Select and button to select and observe more data.

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17.3 Oxygenation Calculation

17.3.1 Calculating Step

1, in the menu, select [calculate] → [Oxygenation Cal.].

2, enter the correct values for each parameter.
3. Select the [calculate] button, you can calculate the value of each output parameter.
 For beyond the reasonable range of output value, which is shown as a yellow background.
Now all parameters will disappear behind the unit, parameter out of range, reasonable range
will be displayed.
 [---] indicates an invalid value

17.3.2 Input Parameter

Chart 17-1 Oxygen Cal. Input Parameter

Abbreviation Unit English full name
C.O. L/min Cardiac output
FiO2 % Percentage fraction of inspired oxygen
PaO2 mmHg Partial pressure of oxygen in the arteries
PaCO2 mmHg Partial pressure of carbon dioxide in the arteries
SaO2 % Arterial oxygen saturation
PvO2 mmHg Partial pressure of oxygen in venous blood
SvO2 % Venous oxygen saturation
Hb g/L Hemoglobin
CaO2 ml/L Arterial oxygen content
CvO2 ml/L Venous oxygen content
VO2 ml/min Oxygen consumption
RQ Respiratory quotient
ATMP mmHg Atmospheric pressure
Height cm Height
weight Kg weight

17.3.3 Output Parameter

Chart 17-2 Oxygen Cal. Output Parameter

Abbreviation Unit English full name
BSA m2 Body surface area
VO2 calc ml/min Oxygen consumption
C(a-v)O2 ml/L Arteriovenous oxygen content difference
O2ER % Oxygen extraction ratio

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DO2 ml/min Oxygen transport

PAO2 mmHg Partial pressure of oxygen in the alveoli
AaDO2 mmHg Alveolar-arterial oxygen difference
CcO2 ml/L Capillary oxygen content
Qs/Qt % Venous admixture
C.O. calc L/min Calculated cardiac output

17.4 Ventilation Calculation

17.4.1 Calculating Step

1, in the menu, select [computing "] → [Ventilation Calculation].

2, enter the correct values for each parameter.
3. Select the [computing] button, you can calculate the value of each output parameter.
 For beyond the reasonable range of output value, which is shown as a yellow background.
Now all parameters will disappear behind the unit, parameter out of range, reasonable range
will be displayed.
 ---] indicates an invalid value

17.4.2 Input Parameter

Chart 17-3 Ventilation Cal. Input Parameter

Abbreviation Unit English full name
FiO2 % Percentage fraction of inspired oxygen
RR Rpm Respiration rate
PeCO2 mmHg Partial pressure of mixed expiratory CO2
PaCO2 mmHg Partial pressure of carbon dioxide in the arteries
PaO2 mmHg Partial pressure of oxygen in the arteries
TV ml Tidal volume
RQ Respiratory quotient
ATMP mmHg Atmospheric pressure

17.4.3 Output Parameter

Chart 17-4 Ventilation Cal. Output Parameter

Abbreviation Unit English full name
PAO2 mmHg Partial pressure of oxygen in the alveoli
AaDO2 mmHg Alveolar-arterial oxygen difference
Pa/FiO2 mmHg Oxygenation ratio
a/AO2 % Arterial to alveolar oxygen ratio
MV L/min Minute volume
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Vd ml Volume of physiological dead space

Vd/Vt % physiological dead space in percent of tidal volume
VA L/min Alveolar volume

17.5 Hemodynamic Calculation

17.5.1 Calculating Step

1. In the menu, select [calculate] → [Hemodynamic Cal.].

2. Enter the correct values for each parameter.
 If the patient is under guardianship is calculated, then HR, Art Mean, PA Mean CVP and the
default value is the current real-time measurements; If you have just performed CO
measurements, the default value CO is chosen more times the average CO measurements;
height and weight from the patient information entered. When the monitor cannot be selected
to provide these data, the display is blank, you need to manually enter.
 If the patient is not on the guardianship of the calculation, you need to verify or modify all
input values.
3. Select the [calculate] button, you can calculate the value of each output parameter.
 For beyond the reasonable range of output value, which is shown as a yellow background.
Now all parameters will disappear behind the unit, parameter out of range, reasonable range
will be displayed.
 [---] indicates an invalid value

17.5.2 Input Parameter

Chart 17-5 Hemodynamic Cal. Input Parameter

Abbreviation Unit English full name
C.O. L/min Cardiac output
HR bpm Heart rate
PAWP mmHg Pulmonary artery wedge pressure
Art Mean mmHg artery mean pressure
PA Mean mmHg Pulmonary artery mean pressure
CVP mmHg Central venous pressure
EDA ml End-diastolic volume
Height cm Height
weight Kg weight

17.5.3 Output Parameter

Chart 17-6 Hemodynamic Cal. Output Parameter

Abbreviation Unit English full name
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C.I. L/min/m2 Cardiac index

2
BSA m Body surface area
SV ml Stroke volume
2
SI ml/m Stroke index
5
SVR DS/cm Systemic vascular resistance
SVRI DS/ m2/cm5 Systemic vascular resistance index
5
PVR DS/cm Pulmonary vascular resistance
2 5
PVRI DS/ m /cm Pulmonary vascular resistance index
LCW Kg.m Left Cardiac work
2
LCWI Kg.m/m Left Cardiac work index
LVSW g.m Left ventricular stroke work
2
LVSWI g.m/ m Left ventricular stroke work index
RCW Kg.m Right Cardiac work
RCWI Kg.m/m2 Right Cardiac work index
RVSW g.m Right ventricular stroke work
2
RVSWI gm./ m Right ventricular stroke work index
EF % Ejection fraction

17.6 Renal Function Calculation

17.6.1 Calculating Step

1. In the menu, select [calculate] → [Renal Cal.].

2. Enter the correct values for each parameter.
3. Select the [calculate] button, you can calculate the value of each output parameter.
 For beyond the reasonable range of output value, which is shown as a yellow background.
Now all parameters will disappear behind the unit, parameter out of range, reasonable range
will be displayed.
 [---] indicates an invalid value

17.6.2 Input Parameter

Chart 17-7 Renal Function Cal. Input Parameter

Abbreviation Unit English full name
URK mmol/L Urine potassium
URNa mmol/L Urinary sodium
Urine ml/24h Urine
Posm mOsm/kgH2O Plasm osmolality
Uosm mOsm/kgH2O Urine osmolality
SerNa mmol/L Serum sodium
Cr μmol/L creatinine

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UCr μmol/L Urine creatinine

BUN mmol/L Blood urea nitrogen
Height cm Height
weight Kg weight

17.6.3 Output Parameter

Chart 17-8 Renal Function Cal. Output Parameter

Abbreviation Unit English full name
URNaEx mmol/24h Urine sodium excretion
URKEx mmol/24h Urine potassium excretion
Na/K % Sodium potassium ratio
Can ml/24h Clearance of sodium
Clcr ml/min Creatinine clearance rate
FENa % Fractional excretion of sodium
Cosm ml/min Osmolar clearance
CH2O ml/h Free water clearance
U/P osm Urine to plasma osmolality ratio
BUN/Cr Blood urea nitrogen creatinine ratio
U/Cr Urine-serum creatinine ratio

17.7 MEWS System

 Open the Mean of the 【calculate】, select 【MEWS System】button to bring up the【MEWS
System】menu. Menu display as follows：

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Fig 17-1 MEWS System menu

 Select【Clear Data】: Clear the previous parameter values.
 Select【Warning process】:Open the view of the Warning process, Warning process default
menu as shown below:

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Fig 17-2 Warning scroe process

 Enter the appropriate HR, RESP, NIBP, TEMP measured values and states of consciousness.
State of consciousness for the drop-down box, including four: wide awake, respond to voice,
respond to pain, no response.
 Select【start score】: System start score automatically.

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Fig 17-1 MEWS result

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Chapter18 Spot Check

18.1 Outline

This monitor provides spot metering function, you can measure the patient's heart rate, blood
pressure, pulse rate, body temperature, oxygen, MEW and spot check data can be transmitted in a
timely manner to the CMS.

18.2 Set Point Measurement

The monitor can be set to continuous measurement and spot check measurement modes.
The monitor is set to the path spot check mode,【Factory Maintenance】→【spot check】→
【on】,then it will open the spot check switch. 【mean】→【monitor type>>】will monitor type
is set to spot check, click【OK】 , the success of the monitor is set to spot check mode.

18.3 Use the Spot Check

Spot check mode is set up, will appear in the hotkey area measured point , click the button
to bring up the【patient info】 menu, as shown below:

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Fig 18-1 Patient info menu

【Surname】: The patient's name

【Name】: The patient's name
【Case】: Patient Case number cannot be empty, otherwise it will not be able to send data.
【Gender】: Male, female, other
【Patient Cat.】: Adu, ped and neo
【Paced】: Yes, No
【Height】: The patient's height
【Weight】: Patient weight
【Blood Type】: A, B, AB, O
【Admit date】 : Patient admission date
【Birthday】: Patient Date of Birth
Fill out patient information, click 【OK】, the following interface pops up:

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Fig 18-2 Spot Check results

【Calculate 】: Calculate MEWS score
【OK】: Sending data to CMS
【Review】: Review patient information and measurement spot check View
【Cancel】: Cancel the spot check data
The review of spot check window as shown below:

Fig 18-3 Spot Check Review

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Select 【Select all】, you can select all data in the current page.
Select【Delete】 , you can delete the selected data.
Select【Send】, you can send data to the central station timeout.

You can select and button, up or down to view the spot check review table.

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Chapter19 Recording (Optional)

19.1 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. 19-1 Recorder

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

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19.2 Loading Paper

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

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

19.3 Setting up the Recorder

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

Fig. 19-2 Recorder setup

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

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

19.4 Clearing Recorder

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

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

 Do not add unnecessary force to the thermal head.

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Chapter20 Battery

20.1 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 5 hours uninterruptedly.
3. Disconnect the AC power and turn on 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.

20.2 Overview

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

The battery icon on the screen indicates the battery status:

Battery is working properly and is fully charged.

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

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

turn off automatically.

Monitor battery is not installed.

Battery is properly installed and being charged.

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

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20.3 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.

20.4 Battery Usage Guide

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

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

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

Warning

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 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.

20.5 Battery Recycling

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

Warning

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

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Chapter21 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.

Standard accessories are as follows:

Standard
No. Name Specifications & characteristics
quantity
1 3/5-lead ECG cable Adult 5-lead all-in-one clip 1
2 Electrode slice 50mm×55mm, adult, disposable 1
3 SPO2 probe Adult finger clip 1
Blood pressure cuff Adult repetitive single-tube cuff 1
Blood pressure gas nozzle Metal 1
4
Blood pressure extension 3M gray
1
tube
5 10K-type temperature probe Adult body surface 1
Detachable four-cell lithium battery
6 2600mAh lithium battery 1
(11.1V 2600mAh)
7 Ground wire V0020A 1
8 Power cord 3×0.75mm2 10A 250V L=2M 1

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21.1 ECG
12-pin ECG cable
Supported Length Length
Symbol Applicable
lead Type (main (lead Code
standard objects
wires cable) cable)
Defibrillation
3-lead AHA Adult 2.7m 0.9m 040-000050-00
type
Defibrillation
5-lead AHA Adult 2.7m 0.9m 040-000052-00
type
Defibrillation
3-lead AHA Neonatal 0.9m 040-000293-00
type
12pin Neo 3-Lead ECG Extension Cable 2.7m 040-000292-00

21.2 SpO2
Northern SpO2 Sensor
Applicable
Applicable objects Type Length Code
parts
Adult Fingers, toes Reusable 3m 040-000031-00
Pediatric Fingers, toes Reusable 3m 040-000260-00
Neonatal Fingers, toes Reusable 3m 040-000257-00
SpO2 Extension Cable(optional) Reusable 1.5m 040-000166-00

Masimo SpO2 Sensor

Type Model / PN Patient category
M-LNCS DCI Adult finger
Reusable M-LNCS DCIP Pediatric finger
M-LNCS YI Neonatal
M-LNCS Neo Neonatal foot
Disposable
M-LNCS Inf Infant toe

Masimo SpO2 Extension cable

Accessories Model / PN

Masimo SpO2 Patient cable: 10ft M-LNC-10

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21.3 NIBP

1. Blood pressure cuff

Applicable
Applicable objects Type Remark Code
parts
Adult Arm or thigh Reusable Single-tube 040-000010-00
Large Adult Arm or thigh Reusable Single-tube 040-000182-00
Pediatric Arm or thigh Reusable Single-tube 040-000179-00
Neontal Arm or thigh Reusable Single-tube 040-000184-00
Infant Arm or thigh Reusable Single-tube 040-000003-00

2. Blood pressure gas nozzle

Mechanical life
Operating Applicable
(connecting and Remark Code
temperature parts
disconnecting)
Pull-off force of
Blood gas connector
-30℃~+60℃ pressure > 1000 times and extension 040-000071-00
cuff tube is greater
than 5kg

3. Blood pressure extension tube

Applicable objects Type Length Remark Code
Reusable Used together
Adult, child 3m 040-000070-00
with cuff

21.4 Temp

10K-type temperature probe

Applicable
Applicable parts Type Length Code
objects
Adult, child Body surface Reusable 3m 040-000030-00
Adult, child Rectal/Esophageal Reusable 3m 040-000055-00
Neonatal Body surface Reusable 3m 040-000067-00

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Appendix A Specifications

A.1 Safety Specifications

A.1.1 Product Category

In accordance with classification specified in the European Medical Device Directive

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

Category Name Specification

93/42/EEC ohm IIb

Medical Devices
Directive Category

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

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

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

protection grade

Explosion Common equipment, no explosion protection

protection grade

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

Operating mode Continuous/Spot check

Movement Portable

A.1.2 Power Specifications

Parameter Specification
External AC power
Input voltage 100-240V~
Input current 1.5A
Frequency 50/60Hz
Internal power supply: Lithium-ion battery

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Rated battery voltage d.c. 14.8V

Battery capacity 2600mAh, optional 5200mAh/7400mAh
Maximum supply time About 5 hours(2600mAh), 10 hours(5400mAh), 15 hours(7400mAh)
Charging time About 3 hours in power on state(2600mAh)
Minimum supply 16.8V
voltage

A.2 Hardware Specifications

A.2.1 Physical Specifications

Dimensions 175×275×175mm (L×W×T)

Weight < 3kg under standard configuration

A.2.2 Display

Host Monitor
Type Color TFT LCD
Screen Size Resolution
8.4 inch 600×800 pixels

A.2.3 Host LED

Alarm indicator 1 (yellow / red)

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

A.2.4 Audio Instruction

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

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

A.2.5 Recorder

Category Thermal spot

Printing width 48mm

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Resolution ratio Flat direction in curve mode 32dot/mm

Vertical direction 8dot/mm
Flat direction in image mode 8dot/mm
Length of recorder paper 20m
Recording speed 12.5mm/s, 25mm/, 50mm/s
Recording wave 2 waves or 3waves

A.2.6 Alarm Signal

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

A.2.7 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.3 Measurement Specifications

A.3.1 ECG/TEMP/RESP Specifications

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

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

HR
Adult: 15bpm~300bpm
Measuring range 3/5-lead monitoring
Pediatric/Neonatal: 15bpm~350bpm
Resolution 1bpm
Heart rate measurement ±1bpm or ±1%, whichever is greater
error

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

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

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A.3.2 NIBP Specifications

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

Standards compliant
EN/IEC 60601-1.
Measurement method Automatic oscillometric method
Operating mode Manual, automatic, continuous
Useful life 100, 000 times
Measurement interval 1/2/3/4/5/10/15/30/60/90/120/180/240/480min
in automatic mode
Typical measurement 20~40s
time
Adult Pediatric Neonatal
Normal mode
Systolic 40-270 40-230 40-135
measuring range
Mean 20-230 20-165 20-105
(mmHg)
Diastolic 10-210 10-145 10-95
Maximum average error: ±5mmHg
Measurement accuracy
Maximum standard deviation: 8mmHg
Resolution 1mmHg
Default Pressure setting range
Adult 150mmHg 80~240mmHg
Initial inflation pressure
Pediatric 100mmHg 80~200mmHg
Neonatal 100mmHg 60～120mmHg
Overpressure Adult: 300mmHg
protection point Pediatric: 240mmHg
(software) Neonatal: 150mmHg
Overpressure Adult: 320~330mmHg
protection point Pediatric: 265~275mmHg
(hardware) Neonatal: 160~165mmHg
Pressure accuracy ±3mmHg
Electrical characteristics
Supply voltage 10V~14V DC
Maximum power 3.6w
consumption
Quiescent current 50mA
Maximum current 180mA
during measurement
Maximum current 300mA
during inflation

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A.3.3 SpO2 Specifications

Northern SpO2 Module

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

Masimo SpO2 Module

SpO2

Measurement range 0% to 100%

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

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

PR

Measurement range 25 bpm to 240 bpm

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

PI

Measurement range 0.05% to 20%

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

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

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

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

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

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

 Mobile communication devices or wireless network devices may have an impact on

the device.

Electromagnetic Emission Guidelines and Declarations

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

Emission test Compliance Electromagnetic environment - Guide

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

Aquarius® 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 ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
IEC 61000-4-4 ±1 kV I/O for ±1 kV I/O for commercial or hospital
input/output lines input/output lines environment.
(>3 m) (>3 m)
Surge IEC ±1 kV differential ±1 kV differential
61000-4-5 mode mode
±2 kV common ±2 kV common
mode mode
Voltage dips, <5 % UT (>95 % dip <5 % UT (>95 % dip Mains power quality should
short in UT) for 0.5 cycle in UT) for 0.5 cycle be that of a typical
interruptions and commercial or hospital
voltage variations 40 % UT (60 % dip 40 % UT (60 % dip environment. If the user of
on power supply in UT) for 5 cycles in UT) for 5 cycles our product requires
input lines IEC continued operation during
61000-4-11 70 % UT (30 % dip 70 % UT (30 % dip power mains interruptions,
in UT) for 25 cycles in UT) for 25 cycles it is recommended that our
product be powered from
<5 % UT (>95 % dip <5 % UT (>95 % dip an uninterruptible power
in UT) for 5 s in UT) for 5 s supply or a battery.
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 HZ) fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
Note: UT is the AC mains voltage prior to application of the test level.

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Guidance and Declaration - Electromagnetic Immunity

Aquarius® 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 150k to 80MHz 80M to 800MHz 800M to 2.5GHz
(W)
d＝3.5 d＝3.5 d＝
0.01 0.35 0.35 0.23
0.1 1.11 1.11 0.74
1 3.5 3.5 2.34
10 11.07 11.07 7.38
100 35 35 23.24
For transmitters at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: From 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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Appendix C Alarm Information

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

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

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

C.1 Physiological Alarm Information

Source Alarm message L Causes and countermeasures

HR Too High HR value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
M* physiological condition, and check if the patient
HR Too Low
category and alarm limit settings are appropriate for
the patient.
PVCs value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the patient's
PVCS Too High M* physiological condition, and check if the patient
category and alarm limit settings are appropriate for
the patient.
ECG
Asystole H The patient has arrhythmia. Check the patient's
VF/VTA H condition, electrodes, cables and lead wires.
R on T M*
Frequent PVC M*
Couplet PVC M*
Single PVC M*
PVC Bigeminy M*
PVC Trigeminy M*
Tachycardia M*
Bradycardia M*
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Source Alarm message L Causes and countermeasures

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

ST-III Too High the patient.

ST-III Too Low

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

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Source Alarm message L Causes and countermeasures

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

NIBP-Mean Too Low the patient.

NIBP-Dia Too High

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

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

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Source Alarm message L Causes and countermeasures

Replace cable L Defective Cable/Cable Life Expired
Cable Near Cable Life Near Expiration
L
Expiration
SPO2 No Sensor No Sensor Connected
L
Connected
Sensor Expired L Sensor Life Expired
Incompatible Incompatible Sensor
L
Sensor
Unrecognized Unrecognized Sensor
L
Sensor
Replace sensor L Defective Sensor
Check Cable / Check Cable and Sensor Fault
L
Sensor Fault
Sensor Near Sensor Life Near Expiration
L
Expiration
SPO2 No No Adhesive Sensor
L
Adhesive Sensor
Adhesive Sensor Adhesive Sensor Life Expired
L
Expired
Defective Defective Adhesive Sensor/Adhesive Sensor Life
L
Adhesive Sensor Expired
Incompatible Incompatible Adhesive Sensor
L
Adhesive Sensor
Unrecognized Unrecognized Adhesive Sensor
L
Adhesive Sensor
Defective Defective Adhesive Sensor
L
Adhesive Sensor
Sensor Initializing L Sensor Initializing
SPO2 Sensor Off Sensor Off Patient
L
Patient
SPO2 Pulse Pulse Search
L
Search
SPO2 Interference Interference Detected
L
Detected
SPO2 Low Low Perfusion Index
L
Perfusion Index
SPO2 Demo Mode L Demo Mode
Adhesive Life Adhesive Life Near Expiration
L
Near Expiration
Check Sensor Check Sensor Connection
L
Connection
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Source Alarm message L Causes and countermeasures

SpO2 Only Mode SpO2 Only Mode
SPO2 Low Signal Low Signal IQ
L
IQ
MasimoSET MasimoSET Processing Active
L
Processing Active
SPO2 Too Much Too Much Ambient Light
L
Ambient Light
NIBP Comm. Stop H NIBP module failure, or communication failure
NIBP Comm. Error L between the module and the host; please restart the
NIBP Self check device.
H
error
NIBP CFG Error H
NIBP NIBP system error H If failure occurs during measurement, the system can’t
analyze and calculate. Check the patient's condition,
Measurement
L check the connections or replace the cuff, and then
timeout
re-test.
The used cuff does not match the set patient category.
Cuff type error L
Verify the patient category and replace the cuff.
Cuff loose or no NIBP cuff isn’t placed or connected properly, or there
L
cuff is 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
NIBP measuring range.
Patient's pulse may be weak or cuff is too loose. Check
the condition of the patient, and place the cuff in a
NIBP signal weak L
suitable position. If the failure persists, replace the
cuff.
NIBP signal Excessive movement may result in too much motion
unstable L artifact or interference in the signal during
measurement.
NIBP signal L Motion signal amplitude is too large due to movement

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Source Alarm message L Causes and countermeasures

saturated 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
Module reset failed L
blocked, and then restart the measurement.

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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 Neonatal
Alarm level Mid Mid Mid
Alarm record Off Off Off
Lead type 5-lead 5-lead 5-lead
Calculation channel Auto Auto Auto
Power frequency suppression On On On
Alarm limits 50~120 on 75~160 on 100~200 on
ST segment
Off Off Off
ST analysis
segment Alarm level Mid Mid Mid
analysis Alarm record Off Off Off
Alarm limits -0.2~0.2 on -0.2~0.2 on -0.2~0.2 on
Alarm level Mid Mid Mid
ECG Alarm record Off Off Off
Alarm limits 0~10 on 0~10 on 0~10 on
Alarm
Arrhythmia On On On
switch
analysis ARR
Alarm
alarm Mid Mid Mid
level
settings
Alarm
Off Off Off
record
Gain x1 x1 x1
Wave velocity 25.0mm/s 25.0mm/s 25.0mm/s
Filter mode Monitor Monitor Monitor
Wave color Green Green Green
Wave style Color scale Color scale Color scale
Alarm level Mid Mid Mid
Alarm record Off Off Off
Pressure unit mmHg mmHg mmHg
NIBP
Measurement mode Adult Child Infant
Interval Manual Manual Manual
Display color White White White

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Pre-inflation value 150 100 100

Systolic blood pressure limit 90~160 on 70~120 on 40~90 on
Mean blood pressure limit 60~110 on 50~90 on 25~70 on
Diastolic blood pressure limit 50~90 on 40~70 on 20~60 on
Alarm level Mid Mid Mid
Alarm record Off Off Off
Alarm limits 90~100 on 90~100 on 90~95 on
SPO2
Wave velocity 25.0 25.0 25.0
Wave color Cyan Cyan Cyan
Wave style Line Line Line
Alarm level Mid Mid Mid
Alarm record Off Off Off
Apnea alarm 20 sec 20 sec 20 sec
Alarm limits 8~30 on 8~30 on 30~100 on
RESP
Gain x1 x1 x1
Wave velocity 12.5 12.5 12.5
Wave color Yellow Yellow Yellow
Wave style Line Line Line
Alarm source SPO2 SPO2 SPO2
Alarm level Mid Mid Mid
PR
Alarm record Off Off Off
Alarm limits 50~120 on 75~160 on 100~200 on
Alarm level Mid Mid Mid
Alarm record Off Off Off
Display color White White White
TEMP Temperature unit °C °C °C
T1 alarm limits 36.0~39.0 on 36.0~39.0 on 36.0~39.0 on
T2 alarm limits 36.0~39.0 on 36.0~39.0 on 36.0~39.0 on
TD alarm limits 0.0~2.0 on 0.0~2.0 on 0.0~2.0 on

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