Patient Monitor User Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 198

Patient Monitor

Operator’s Manual
Preface
Manual Purpose
The instructions for safe operation of product in keeping with its function and intended use are contained in this
manual. In order to operate product properly, correct operation and protect patient and operator from injury,
compliance with this manual is first priority.

Depending on the device configuration, some contents of this manual may not apply to your product. Please
keep in touch with the manufacturer or your local sales if you have any questions.

As an indispensable portion of the product, this manual should always be placed near the equipment so that it
can be got easily when needed.

Only clinical professionals, anyone who are under their guidance or people who have been trained adequately
can use this monitor. The unauthorized or the untrained are forbidden to operate the product.

Intended Audience
This Manual applies to clinical professionals with knowledge of medical procedures, practices and terminology
as required for monitoring of critically ill patients.

Illustrations
Setup or data displayed on your monitor may not be necessarily showed in all illustrations in this Manual,
because they are used only as examples.

All names mentioned in this Manual and illustrations are fictitious. Any similarity is purely coincidental.

User Manual Number: 3502‐2350001

Version of this manual: V2.0

Date: August 28, 2020

I
Terms used in this User Manual:
"Window": The current pop‐up operable dialog box on device screen.
"View": The screen when there is no any pop‐up window.
"Button": The operable icon on device screen, which can act as a key function while focused, such as

" "

"Shortcut Key"(Key): The hard key on device panel for realizing certain function, such as " ".
"Long press": The operation pressing shortcut key for over 3 seconds.
"SpO2": Oxygen saturation.
"SpO2 event": Oxygen desaturation event.
Plugin module: Plug‐and‐Play module.
Touchscreen operation and key operation are available. Please perform touch screen calibration before starting
touchscreen operation.
Notes:
1. The password for system setting is 8989, which will be used when requiring, we will not cover it again.
2. This patient monitor can be customized with different functional modules, therefore, the monitor you
purchased may not cover all operation description.

Caution:
Federal law restricts this device to sale by or on the order of a physician.

II
Table of Contents
Chapter 1 Safety ....................................................................................................................................................... 1

1.1 Safety Information ...................................................................................................................................... 1

1.1.1 Warnings.......................................................................................................................................... 1

1.1.2 Cautions ........................................................................................................................................... 2

1.1.3 Notes ............................................................................................................................................... 2

1.2 Equipment Symbols .................................................................................................................................... 3

1.2.1 Symbol/Icon on the Device.............................................................................................................. 3

1.2.2 Icons List on the Screen ................................................................................................................... 4

Chapter 2 The Basics ................................................................................................................................................ 6

2.1 Monitor Description ................................................................................................................................... 6

2.1.1 Product Name and Model ............................................................................................................... 6

2.1.2 Intended Use ................................................................................................................................... 6

2.1.3 Features ........................................................................................................................................... 6

2.2 Main Unit .................................................................................................................................................... 8

2.3 Plugin Modules (For Plugin monitor only) ................................................................................................ 17

2.4 Display Screen .......................................................................................................................................... 19

2.4.1 Message Indication Area ............................................................................................................... 20

2.4.2 Statusbar ....................................................................................................................................... 21

2.4.3 Parameter Area and Waveform Area ............................................................................................ 23

2.5 Views Management .................................................................................................................................. 24

Chapter 3 Operating Instructions ........................................................................................................................... 26

3.1 Installation ................................................................................................................................................ 26

3.1.1 Unpacking and Checking ............................................................................................................... 26

3.1.2 Environmental Requirements ........................................................................................................ 26

3.2 Getting Started ......................................................................................................................................... 27

3.2.1 Connecting to Power Source ......................................................................................................... 27

3.2.2 Turning the Monitor On................................................................................................................. 28

3.2.3 Starting Monitoring ....................................................................................................................... 28

3.3 Turning the Monitor Off ........................................................................................................................... 29

3.4 Using Keys ................................................................................................................................................. 29

3.4.1 Shortcut Key .................................................................................................................................. 29

III
3.4.2 Buttons and Keyboard ................................................................................................................... 30

3.5 Using the Touchscreen ............................................................................................................................. 31

3.6 Setting the Screens ................................................................................................................................... 31

3.7 Using the Main Menu ............................................................................................................................... 32

3.8 Changing System Settings ......................................................................................................................... 33

3.8.1 Changing General Settings............................................................................................................. 33

3.8.2 Setting the Date and Time ............................................................................................................. 35

3.8.3 Network Settings ........................................................................................................................... 35

3.8.4 Printer Settings .............................................................................................................................. 36

3.9 Operating Modes ...................................................................................................................................... 37

3.9.1 Real Time Mode............................................................................................................................. 37

3.9.2 Demo Mode ................................................................................................................................... 37

3.9.3 Standby Mode ............................................................................................................................... 37

Chapter 4 Patient Data Management..................................................................................................................... 38

4.1 Apply an existed patient’s document ....................................................................................................... 38

4.2 Create a new patient’s document ............................................................................................................ 38

4.3 Edit a patient document ........................................................................................................................... 38

4.4 Delete a patient document....................................................................................................................... 39

4.5 Exporting Data .......................................................................................................................................... 39

4.5.1 Exporting Data from Monitor to a USB Driver ............................................................................... 39

4.6 Connecting to a Central Monitoring System ............................................................................................ 40

Chapter 5 User Screens .......................................................................................................................................... 41

5.1 Tailoring/Setting Your Screens .................................................................................................................. 41

5.1.1 Changing the Display Theme ......................................................................................................... 41

5.1.2 Changing the Color of Waveforms and Parameter ........................................................................ 41

5.2 Display Views ............................................................................................................................................ 42

5.2.1 General View ................................................................................................................................. 42

5.2.2 Big Font View ................................................................................................................................. 43

5.2.3 All ECG Trace view ......................................................................................................................... 44

5.2.4 NIBP List view ................................................................................................................................ 45

5.2.5 OxyCRG view.................................................................................................................................. 45

5.2.6 Short trends view .......................................................................................................................... 45

IV
5.2.7 CSM View....................................................................................................................................... 46

Chapter 6 Alarms .................................................................................................................................................... 48

6.1 Alarm Categories ...................................................................................................................................... 48

6.2 Alarm Levels ............................................................................................................................................. 48

6.3 Alarm Indicators ....................................................................................................................................... 50

6.3.1 Alarm lamp .................................................................................................................................... 50

6.3.2 Alarm message .............................................................................................................................. 50

6.3.3 Highlighting Numeric ..................................................................................................................... 50

6.3.4 Audible Alarm Tones ...................................................................................................................... 50

6.3.5 Alarm Status Symbols: ................................................................................................................... 50

6.3.6 Changing Alarm Volume ................................................................................................................ 52

6.4 Understanding the Alarm Setting ............................................................................................................. 52

6.4.1 High and Low Alarm Setting Range ............................................................................................... 55

6.4.2 Factory Default Alarm Limit Setting Value ..................................................................................... 57

6.5 Testing Alarms .......................................................................................................................................... 59

6.6 When an Alarm Occurs ............................................................................................................................. 59

Chapter 7 ECG Monitoring ..................................................................................................................................... 60

7.1 Introduction .............................................................................................................................................. 60

7.2 Safety Information .................................................................................................................................... 60

7.3 Preparing to Monitor ECG ........................................................................................................................ 61

7.3.1 Preparing the Patient and Device .................................................................................................. 61

7.3.2 ECG Electrodes Placement............................................................................................................. 62

7.4 Understanding the ECG Display ................................................................................................................ 63

7.5 Changing ECG Settings .............................................................................................................................. 64

7.6 About Arrhythmia Detection and Template Learning .............................................................................. 65

7.6.1 Understand the ARR Type.............................................................................................................. 66

7.7 About S‐T Segment Monitoring ................................................................................................................ 67

7.8 Freezing Waveform ................................................................................................................................... 67

7.9 Factors Affecting ECG signal ..................................................................................................................... 67

Chapter 8 Monitoring Respiration (RESP) .............................................................................................................. 69

8.1 Introduction .............................................................................................................................................. 69

8.2 Safety Information .................................................................................................................................... 69

V
8.3 Understanding the RESP Display .............................................................................................................. 69

8.4 Changing RESP Settings ............................................................................................................................ 70

Chapter 9 Monitoring NIBP .................................................................................................................................... 72

9.1 Introduction .............................................................................................................................................. 72

9.1.1 The Oscillometric Blood Pressure Measurement .......................................................................... 72

9.1.2 The Oscilometric method vs. the Korotkoff Sound Method.......................................................... 72

9.2 Safety Information .................................................................................................................................... 72

9.3 Measurement Limitations ........................................................................................................................ 73

9.4 Measurement Mode................................................................................................................................. 73

9.5 Setting Up the NIBP Measurement .......................................................................................................... 74

9.5.1 Preparing to Measure NIBP ........................................................................................................... 74

9.5.2 Starting and Stopping Measurements ........................................................................................... 74

9.5.3 Factors Affecting NIBP Measurement............................................................................................ 75

9.6 Understanding the NIBP Numerics ........................................................................................................... 76

9.7 Changing NIBP Settings ............................................................................................................................ 76

Chapter 10 Monitoring Oxygen Saturation (SpO2) ................................................................................................. 79

10.1 Introduction ............................................................................................................................................ 79

10.2 Safety Information .................................................................................................................................. 79

10.3 Apply the Sensor .................................................................................................................................... 80

10.4 Using Probe and Sensor.......................................................................................................................... 81

10.5 Understanding the SpO2 and PR Display ................................................................................................ 83

10.6 Changing SpO2 and PR Settings .............................................................................................................. 83

10.7 Nellcor SpO2 Module (Optional) ............................................................................................................. 84

Chapter 11 Monitoring Temperature ..................................................................................................................... 86

11.1 Introduction ............................................................................................................................................ 86

11.2 Safety Information .................................................................................................................................. 86

11.3 Making a TEMP Measurement ............................................................................................................... 86

11.4 Understanding the TEMP Display ........................................................................................................... 87

11.5 Changing TEMP Settings ......................................................................................................................... 87

Chapter 12 Monitoring IBP ..................................................................................................................................... 88

12.1 Introduction ............................................................................................................................................ 88

12.2 Safety Information .................................................................................................................................. 88

VI
12.3 Setting Up the IBP Measurement ........................................................................................................... 89

12.3.1 Understanding IBP Icon and IBP Plugin Box (Optional) ............................................................... 89

12.3.2 IBP Transducer Kit Connection .................................................................................................... 89

12.4 Understanding the IBP Display ............................................................................................................... 90

12.5 Changing IBP Settings ............................................................................................................................. 91

Chapter 13 Monitoring Carbon Dioxide (CO2) ........................................................................................................ 92

13.1 Introduction ............................................................................................................................................ 92

13.2 Safety Information .................................................................................................................................. 92

13.3 CO2 Sensor Connection ........................................................................................................................... 94

13.3.1 Sidestream CO2 Sensor Connection............................................................................................. 94

13.3.2 Mainstream CO2 Sensor Connection ........................................................................................... 96

13.4 Measurement Limitations ...................................................................................................................... 96

13.5 Troubleshooting the Sidestream CO2 Sampling System ......................................................................... 97

13.6 Understanding the CO2 Display .............................................................................................................. 97

13.7 Changing CO2 Settings ............................................................................................................................ 97

Chapter 14 Monitoring Cardiac Output (C.O.)...................................................................................................... 100

14.1 Introduction .......................................................................................................................................... 100

14.2 Safety Information ................................................................................................................................ 100

14.3 Setting Up the C.O. Measurement ....................................................................................................... 100

14.3.1 Understanding C.O. Icon and C.O. Plugin Box (Optional) .......................................................... 100

14.3.2 C.O. Measuring Procedure......................................................................................................... 101

14.3.3 The placing process of catheter................................................................................................. 101

14.4 Changing C.O. Settings.......................................................................................................................... 102

14.5 Understanding the C.O. Display ............................................................................................................ 103

14.6 Factors Affecting C.O.Measurement .................................................................................................... 106

Chapter 15 Monitoring Anaesthesia Gas (AG) ..................................................................................................... 108

15.1 Introduction .......................................................................................................................................... 108

15.2 Safety Information ................................................................................................................................ 108

15.3 Measurement Limitation ...................................................................................................................... 108

15.4 Setting Up the AG Measurement ......................................................................................................... 108

15.4.1 Instruction for PHASEIN IRMA Mainstream Multigas Analyzer ................................................. 109

15.4.2. Instruction for PHASEIN ISA Sidestream Analyzer .................................................................... 112

VII
15.6 Understanding the AG Display.............................................................................................................. 115

15.7 Changing AG Settings ........................................................................................................................... 115

Chapter 16 Monitoring CSM ................................................................................................................................. 118

16.1 Introduction .......................................................................................................................................... 118

16.2 Safety Information ................................................................................................................................ 118

16.3 Understanding CSM Parameters .......................................................................................................... 118

16.4 CSM Processes ...................................................................................................................................... 120

16.5 Changing CSM Settings ......................................................................................................................... 122

Chapter 17 Review ............................................................................................................................................... 123

17.1 ARR Events ............................................................................................................................................ 123

17.2 Trend Graph .......................................................................................................................................... 124

17.3 NIBP List ................................................................................................................................................ 124

17.4 ECG Waveforms .................................................................................................................................... 125

17.5 Alarm Event .......................................................................................................................................... 125

17.6 SpO2 Event ............................................................................................................................................ 126

17.7 CSM Records (Optional) ....................................................................................................................... 126

17.8 C.O. History Record Review .................................................................................................................. 127

Chapter 18 Calculations........................................................................................................................................ 129

18.1 Introduction .......................................................................................................................................... 129

18.2 Safety Information ................................................................................................................................ 129

18.3 Medication Calculation (Medicine Dosage Calculation) ....................................................................... 129

18.4 Oxygenation Calculation ....................................................................................................................... 132

18.5 Ventilation Calculation ......................................................................................................................... 136

18.6 Renal Function Calculation ................................................................................................................... 139

18.7 HEMO.(Hemodynamic Calculation) ...................................................................................................... 142

Chapter 19 Tourniquet ......................................................................................................................................... 145

Chapter 20 Printing .............................................................................................................................................. 146

20.1 Using a Printer ...................................................................................................................................... 146

20.2 Loading Printing Paper ......................................................................................................................... 146

20.3 Attentions ............................................................................................................................................. 147

20.4 Performing Printing .............................................................................................................................. 148

20.4.1 Print Real Time Data .................................................................................................................. 148

VIII
20.4.2 Print History Records ................................................................................................................. 150

20.5 Cleaning the Printing Head of Printer................................................................................................... 151

Chapter 21 Other Functions ................................................................................................................................. 152

21.1 System Information .............................................................................................................................. 152

21.2 Nurse Call Settings (Optional)............................................................................................................... 152

Chapter 22 Battery ............................................................................................................................................... 153

22.1 Overview .............................................................................................................................................. 153

22.2 Battery Maintenance ............................................................................................................................ 153

22.3 Battery Recycling .................................................................................................................................. 154

Chapter 23 Cleaning and Disinfection .................................................................................................................. 155

23.1 Cleaning the Device and Accessories ................................................................................................... 155

23.2 Disinfecting the Device and Accessories .............................................................................................. 156

Chapter 24 Maintenance ...................................................................................................................................... 157

24.1 Daily Examination ................................................................................................................................. 157

24.2 Routine Maintenance ........................................................................................................................... 157

24.3 ECG Verification .................................................................................................................................... 158

24.4 Pressure Accuracy Verification ............................................................................................................. 158

24.4 IBP Calibration (Optional) ..................................................................................................................... 160

24.5 CO2 Test ................................................................................................................................................ 161

24.6 Calibrating AG ....................................................................................................................................... 161

25 Accessories ...................................................................................................................................................... 162

26 Technical Specifications ................................................................................................................................... 163

26.1 ECG ....................................................................................................................................................... 163

26.2 RESP ...................................................................................................................................................... 163

26.3 TEMP .................................................................................................................................................... 164

26.4 NIBP ...................................................................................................................................................... 164

26.5 SpO2 ...................................................................................................................................................... 165

26.6 Pulse Rate ............................................................................................................................................. 165

26.7 CO2 ........................................................................................................................................................ 166

26.8 CSM ...................................................................................................................................................... 166

26.9 IBP......................................................................................................................................................... 166

26.10 Cardiac Output (C.O.) ......................................................................................................................... 167

IX
26.11 Anaesthesia Gas (AG) ......................................................................................................................... 167

26.12 S‐T Segment ........................................................................................................................................ 173

26.13 Data Recording ................................................................................................................................... 173

26.14 Other Technical Specifications............................................................................................................ 173

26.15 Classification ....................................................................................................................................... 174

26.16 Operating Environment ...................................................................................................................... 174

26.17 Storage................................................................................................................................................ 175

26.18 Transportation .................................................................................................................................... 175

26.19 Packaging ............................................................................................................................................ 175

Chapter 27 Troubleshooting ................................................................................................................................ 176

27.1 No Display on the Screen ..................................................................................................................... 176

27.2 Excessive ECG Signal Interference or too Thick Baseline ...................................................................... 176

27.3 No Blood Pressure and Pulse Oxygen Measures .................................................................................. 176

27.4 Troubleshooting of CSM ....................................................................................................................... 176

27.5 No CO2 Readings ................................................................................................................................... 177

27.6 System Alarm ........................................................................................................................................ 177

27.7 Alarm Problems .................................................................................................................................... 177

27.8 Power Supply Failure ............................................................................................................................ 178

27.9 Troubleshooting of IBP ......................................................................................................................... 178

A Alarm Information .......................................................................................................................................... 179

B Status/Error during NIBP Monitoring ............................................................................................................. 180

C Status/Error during CO2 Monitoring............................................................................................................... 181

D Typical Pressures and CO2 Readings at Altitudes ........................................................................................... 182

E EMC Compliance ............................................................................................................................................ 183

X
Operator’s Manual for Patient Monitor

Chapter 1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the operator of the monitor
must pay attention to and abide by. There are additional safety statements in other chapters or sections, which may
be the same as or similar to the following, or specific to the operations.

 Warning: indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.

 Caution: indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.

☞ Note: provides application tips or other useful information to ensure that you get the most
from your product.

1.1.1 Warnings

 WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse inhibition function is available in this
device, the heart rate meter may continue to count the pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument.

 Disconnect the monitor and sensors from the patient before MRI scanning. Using them during MRI could cause
burns or adversely affect the MRI image or the monitor’s accuracy.

 If uncertain about the accuracy of any measurement, firstly check the patient’s vital signs by any alternative
means, and then make sure the monitor is functioning properly.

 The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical
signs and symptoms.

 Monitor a single person at a time.

 The monitor is defibrillation‐proof. Verify that the accessories can function safely and normally and the
monitor is grounded properly before conducting defibrillation.

 The monitor is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous
oxide.

 Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient being
monitored.

 The alarm limit value shall be within the measuring range, or it may disable the alarm system. Please refer to
the related chapter for alarm limit range.

 A HAZARD can exist if different alarm presets are used for the same or similar device in a single area.

 Do not silence the audible alarm if patient safety may be compromised.

1
Operator’s Manual for Patient Monitor

 The monitor is prohibited from applying to those who have severe hemorrhagic tendency or who are with
sickle cell disease for they may develop partial bleeding when this monitor is used to take the blood pressure
measurement.

 All the connecting cables and tubes of the applying parts should be kept away from the patient's neck to
prevent any possible suffocation of the patient.

 To prevent the risk of the short circuit and to ensure the ECG signal quality, the device must be properly
grounded.

 The device should be considered an early warning device as a trend towards patient deoxygenation is indicated,
blood samples should be analyzed by a laboratory CO‐oximeter to completely understand the patient's
condition.

 Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic
patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.

 Please peruse the relative content about the clinical restrictions and contraindication.

 It is recommended that the clinical operator regularly test the device and accessories. The visual and auditory
alarm signal can be checked by disconnect accessories or by setting it at Demo mode to simulate alarm event.

 Do not allow service or maintenance on the device whilst being used on a patient.

1.1.2 Cautions

 All the parts of the monitor should NOT be replaced at will, substitution of a component different from that
supplied by the manufacturer might result in measurement error. If necessary, please use the components
provided by the manufacturer or those that are of the same model and standards as the accessories along with
the monitor which are provided by the same factory, otherwise, negative effects concerning safety and
biocompatibility etc. may be caused. No modification of this device is allowed.

 The accessories which can be used repeatedly should be cleaned thoroughly before use on another patient.
Please refer to the related chapter for maintenance method.

 If the monitor falls off accidentally, please do NOT operate it before its safety and technical indexes have been
tested minutely and positive testing results obtained.

 Do not immerse the monitor or its accessories in liquid to clean.

 The system might not meet its performance specifications if stored or used outside the manufacturer’s
specified temperature and humidity ranges.

1.1.3 Notes

☞ All combinations of equipment must be in compliance with the standard IEC 60601‐1.

☞ The NIBP module of the device was clinically investigated according to the requirements of ISO 81060‐2:2013.

☞ Please do not position the device so that it is difficult to connect the plug of the power cord.

☞ After the life cycle of the monitor and its accessories has been met, disposal should be accomplished following
national and/or local requirements.
2
Operator’s Manual for Patient Monitor

☞ If the user requests more information such as circuit diagrams, parts list and product descriptions, for repairs
carried out by qualified technical personnel, please contact us.

1.2 Equipment Symbols

1.2.1 Symbol/Icon on the Device

Item Symbol/Icon Description

1 Power switch

2 View setting key


or
3 Alarm reset key

4 Freeze/ Unfreeze key

5 Start/Cancel NIBP measurement

6 Print

7 Display view key

8 AC power indicator

9 Working power supply indicator

10 Type CF applied parts with defibrillation‐proof

11 Warning ‐‐‐ refer to User Manual

12 Type BF applied parts with defibrillation‐proof

13 Equipotential grounding terminal

14 SN Serial number

15 Battery cover

16 USB connector

17 Network interface

18 Nurse call connector

19 VGA output (optional)

20 Serial port (reserved for future use)

21 ECG Sync output (reserved for future use)

3
Operator’s Manual for Patient Monitor

22 Manufacturing date

23 Manufacturer

24 Alarm silence key


(optional)
The following definition of the WEEE label applies to EU member states
only.
This symbol indicates that this product should not be treated as
household waste. By ensuring that this product is disposed of correctly,
25 you will help prevent bringing potential negative consequences to the
environment and human health. For more detailed information with
regard to returning and recycling this product, please consult the
distributor from whom you purchased it.

This mark means that this device is fully in conformance with the
26
Council Directive Concerning Medical Devices 93/42/EEC.

25 Authorized representative in the European Community

1.2.2 Icons List on the Screen

Icon/info. Description

00000000 Patient ID

/ / Patient type, there are "Adult", "Pediatric" and "Neonate" for optional

Arrhythmia symbol (indicates learning or analysis stage for ARR detection)


/
Alarm sound is mute/off (only available for the device optioned with “Spot‐check
Mode”)

/ Alarm activating status icon/Alarm reset icon

If the alarm function is disabled for one/some parameter, this icon appear(s) on the
corresponding parameter panel(s)

Waveform frozen symbol

Cross cursor for S‐T segment measurement

Heart‐beat symbol

Breath symbol

AC Power supply and the battery is fully charged.

The red blinking exclamatory mark means battery will run out soon and needs to be
charged. Alarm information area will show "Low Battery" message.

4
Operator’s Manual for Patient Monitor

Charging status

/ / One / two / full grid battery voltage left

Printer ready. Paper moving means device is printing.

Printer error. Caused by no paper, uncovered, over‐heat and etc.

Pulse beeper is on

Pulse beeper is off

Network connected / disconnected/ established link to remote server (CMS or HL7


/ /
client)

S‐T +..... The measured S‐T segment level

PI% Perfusion index percentage

%SpO2 Unit of SpO2 in percentage

mmHg/kPa Unit of blood pressure

bpm Unit of heart rate or pulse rate

rpm Unit of respiration rate

Unit of temperature
℃/℉
mm/s Unit of waveform sweeping speed

EMG% Electromyogram interference ratio

SQI Signal quality index

BS% Burst suppression ratio

CSI Cerebral state index

NOTE: some symbols may not appear on your equipment

5
Operator’s Manual for Patient Monitor

Chapter 2 The Basics


2.1 Monitor Description

2.1.1 Product Name and Model

Product name: Patient Monitor

Product Model: See Label in page I

2.1.2 Intended Use

This Patient Monitor is a multi‐functional instrument designed for monitoring the vital physiological signs of adult,
pediatric and neonate patients. With the functions of real‐time recording and displaying parameters, such as ECG,
heart rate (HR), non‐invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration (RESP), body
temperature (TEMP), as well as the optioned monitoring functions, such as end‐tidal CO2 concentration (EtCO2),
invasive blood pressure (IBP), cardiac output (C.O.), anesthetic gas (AG), Cerebral State Index (CSI) and so on, it allows
comprehensive analysis of patient’s physiological conditions.

Note: The CE‐certified patient monitors have the functions of recording and displaying parameters in real‐time of ECG,
heart rate (HR), non‐invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body
temperature (TEMP), and end‐tidal CO2 concentration (EtCO2) for monitoring the physiological conditions of adult and
pediatric patients (age≥3 years old).

Note: This patient monitor can be configured with different parameters, the monitor you purchase may not cover all
functions described above.

 This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed
by qualified professionals or under their guidance. Anyone unauthorized or untrained must not perform any
operation on it.

 The physiological waveforms and parameters and the alarm information displayed by the monitor are only for
the reference of operators, but cannot be used directly to determine the clinical treatment.

Contraindication: please see each section.

2.1.3 Features

This patient monitor can be used to monitor patient’s physiological parameters including ECG, heart rate (HR),
non‐invasive blood pressure (NIBP), oxygen saturation (SpO2), Pulse rate (PR), respiration, temperature, CO2 and CSM
and so on. It has the following features:

 Windows style display view, easy to operate;

 The plugin modular design can extend CO2 and CSM monitoring functions;

 Patient archive management is available;

6
Operator’s Manual for Patient Monitor

 Oxygenation calculation, Ventilation calculation and Renal function calculation is available;

 Multiple display views are available, which can be easily shifted for different monitoring purpose;

 Waveform freezing is available with functions of S‐T segment measurement and arrhythmia analysis;

 The compact database can manage the history records effectively;

 Visual and audible alarm with multiple priority of levels for physiological and technical alarms;

 Intuitive CSM event marking;

 Multilingual display for optional;

 Large capacity storage:


 Up to 2000 hours of trend data,

 Up to 12000 groups of NIBP records;

 2000 groups of oxygen‐desaturation events;

 2000 groups of alarm events;

 Up to 140 hours of ECG waveform;

 2000 groups of ARR event data,

 840 hours of EEG waveform;

 Touchscreen operation and key operation are available;

 Protection against defibrillator discharge, resistance against the interference from electro‐surgical unit; Cardiac
pacemaker pulse detection and inhibition;

 12‐leads ECG function can be configured for full ECG information (optional);

 Network capability for central monitoring;

 Capable to export data to CIS/HIS by HL7 protocol;

 USB data export function is available (only to the patient monitor with plugin module or extended module)

Note: This patient monitor can be configured with different parameters, the monitor you purchase may not cover all
functions described above.

7
Operator’s Manual for Patient Monitor

2.2 Main Unit


We provide 4 series of monitors for options, and the following figures are for illustration only, please refer to the
corresponding figure for the monitor you’ve purchased.

 Series I: 11

Front view

Handle

Nameplate

Connector and icon

Rear view

8
Operator’s Manual for Patient Monitor

Connector and icon

Left view Right view

9
Operator’s Manual for Patient Monitor

 Series II
12 13

Front view Rear view


Connector and icon

Plugin module
installing
location

Left view Right view

10
Operator’s Manual for Patient Monitor

 Series III 11

Front view Rear view

Left view Right view

11
Operator’s Manual for Patient Monitor

 Series IV
11

Front view Rear view

Extended
Module

Left view Right view

12
Operator’s Manual for Patient Monitor

 Front Panel

The above icon and its corresponding description is below.

No. Symbol Description

1 Power switch

2
AC power indicator

3
Working power supply indicator

4 or View setting key

Alarm reset key


5 or
/ Alarm silence key

6
Freeze key

7
NIBP start/cancel key

8
Record/Print key

9
Display view key

10 or Navigation knob

11 or Alarm lamp

13
Operator’s Manual for Patient Monitor

Technical alarm status indicator (optional): an auxiliary


indicator for “Alarm lamp”. It’s used for indicating whether the
12 system in technical alarm status or not. When the system in
technical alarm status, then the indicator in blue, otherwise, it
stays off.

Physiological alarm indicator


13
(optional)

Note: 1. For the software updating reason, the icon for “View setting key” may be (for the latest version)

or , please refer to the monitor in your hand.

For convenient operation, different port is set in different position of the monitor, please refer to the monitor in
your hand.

Description for connector and icon


 Connector

 TEMP1, TEMP2: Temperature probe connectors.


 NIBP: NIBP cuff connector.
 SpO2: SpO2 sensor connector.
 ECG/RESP: ECG cable connector.
 CO2: this connector can be used for external monitoring module such as CO2 measurement (optional).
 AG: this connector can be used for external monitoring module such as AG (Anaesthesia Gas) measurement
(optional).
 CSM: this connector can be used as the CSM sensor cable connector (optional).
 IBP1, IBP2, IBP3, IBP4: these connectors can be used as the IBP sensor cable connector (optional).
 C.O.: this connector can be used as the Cardiac Output sensor cable connector (optional).
 Net: Data cable interface. This function is unavailable for most of the monitors, please refer to the monitor in
your hand.

 : Equipotential grounding terminal.

 : USB data interface. This port is used for data exporting. This function is available for the monitor with
plugin module, please refer to the monitor in your hand.

 a.c. 100~240V, 50/60Hz: Mains power supply socket.


 FUSE 2T1.0AL: Fuse holder; fuse specification: T1.0AL/250V Φ520mm.

 : Nurse call connector. This function is unavailable for most of the monitors, please refer to the monitor in
your hand.

 MONITOR: External display output which will be different depending on the configuration. This function is
unavailable for most of the monitors, please refer to the monitor in your hand.

14
Operator’s Manual for Patient Monitor

 : Network interface. This function is unavailable for most of the monitors, please refer to the monitor in
your hand.

 : Serial port. Reserved for future use (optional).

 : CSM data export interface (optional).

 : ECG Sync output for defibrillation. Reserved for future use (optional).

15
Operator’s Manual for Patient Monitor

 Icon

 S/N: Serial Number.

 Type BF applied parts with defibrillation‐proof.

 Type CF applied part with defibrillation‐proof.

 Warning! Please refer to the manual.

 Nameplate

 The nameplate includes product name, model, CE mark, and manufacturer information and so on.

 Battery slot

Battery cover: Remove the cover to install or change rechargeable battery. Battery specification:
11.1V /4400mAh.
“TO AVOID BATTERY DAMAGE, ALWAYS REMOVE BATTERY(S) BEFORE SHIPPING OR STORAGE”

 Printer (optional)

 " 。。"—— printer indicator. One indicator labeled "POWER" will be on (in green) when the printer is normal
powered on, otherwise, it will be off. Another indicator labeled "ERROR" will be on (in red) when the printer is
malfunction.

16
Operator’s Manual for Patient Monitor

2.3 Plugin Modules (For Plugin monitor only)


This monitor is designed with two slots for the plugin modules which can be inserted in any slot, please insert the
corresponding Plugin module according to your monitoring needs. As shown in below figure, the provided plugin
module has the function to measure one or one group of parameters, for example, CO2 module and CSM module. The
plugin modules can work immediately after inserting.

Plugin Plugin
module module

Plugin modules (Illustration)


Note:

 Refer to the plugin modules in your hand for the detailed function.

 If the customer purchased the monitor with configuration of “Built‐in CSM module”, then your monitor will have
not “Plugin CSM module” (Plug‐and‐Play CSM module). Therefore, you can disregard the description about “Plugin
CSM module”.

Plugin module identification:

1). When the plugin module is inserted into the slot, it will be sensed and powered immediately. After the plugin

module is installed on the monitor, the monitor can identify the function of that module, and add the

corresponding setting items and functional buttons automatically. The plugin module icon will be displayed on the

upper right of the window, at the same time, the waveform area and parameter area will adjust automatically.

2). The monitor will identify the already installed plugin module automatically when the monitor is started up.

3). Hot plugging is available for the plugin module.

4). There are only 2 slots for the plugin modules, if you insert two same modules into the slots, then one of the

modules will be ignored.

Plugin module installation:

Step 1: If the user wants to add additional function (e.g. CO2 monitoring), then insert the plugin module into the slot (L

or R side), please make sure the module is right side up. One beep sound means the module is inserted into the

17
Operator’s Manual for Patient Monitor

monitor, and the indicator on module lights on meaning the plugin module is installed successfully.

Note: if the indicator on the module is off, then pull it out and repeat step 1 to reinstall.

Plugin module installing location:

Plugin module
installing location

(The figure is for illustration only, please refer to the monitor in your hand for actual appearance)

Description:

1). ‐‐‐installing slots for Plugin modules, L or R side.

2). and : the Plugin modules for CO2 and CSM functions. The indicator indicates the working
status of plugin module, blue light means the plugin module is working normal.

3). Description for the icons on Plugin module:


 CO2: transducer connector for CO2 function, it will be different for different configuration, please refer to the
monitor in your hand.
 CSM: transducer connector for CSM function, it will be different for different configuration, please refer to the
monitor in your hand.
4). Button: setting operation for Plugin module

When the Plugin module is inserted into the monitor, then pressing the setting button " " (or " ") on Plugin
module can bring up the corresponding setting window on the screen.

18
Operator’s Manual for Patient Monitor

2.4 Display Screen


Generally, when there is no pop‐up window on the screen, the screen layout of the device includes Message
indication area, Waveform area, Parameter area and Statusbar, as shown in below Figure. Message indication area is
on the top of the screen and Statusbar is on the bottom; Parameter area is on the right of the screen and Waveform
area is on the left.

When there is window pops up, the new pop‐up window is the current operable window displayed on top layer. We
will not cover again.

Message indication area


Waveform 1 Parameter area

Waveform 2 Parameter 1

Waveform area
Waveform 3 Parameter 2

Waveform 4 Parameter 3

Parameter 4

Waveform 5

Parameter 5
Statusbar
Screen layout (refer to actual screen)

19
Operator’s Manual for Patient Monitor

2.4.1 Message Indication Area

From left to right of Message indication area, it shows patient information (including gender, patient ID, patient type
and name), physiological alarm sources, alarm sound status and current date.

Gender PID Patient type Patient name Physiological alarm sources Alarm status
plugin module info.

 Patient information area (as shown in above figure): the patient whose information displayed on Message
indication area is monitored by device currently. Icon " " means the patient is female, " " is male and " " is
unknown. The device presets a default patient information. When the user does not fill any patient information,
the device will use the default patient information. The default patient ID is "00000000", Name is "Noname",
patient type is "Adult". Move the cursor on this information area can shift to "Patient Info." setting window.

 Physiological alarm sources (as shown in above figure): displays physiological alarm source information.

 Alarm status: See Chapter 6 Alarms.

 Plugin module info. (optional): when the plugin modules are identified, the corresponding module icons will

appear on the upper right screen, " " for CO2 module, for IBP module, and " " for CSM module.

Note:

If you purchased the Monitor with extended module, then the corresponding module icon(s) will also appear on
the upper right screen.

20
Operator’s Manual for Patient Monitor

2.4.2 Statusbar
From left to right of the statusbar, it shows of "Menu", "Alarm" and "Review" button, technical alarm event; printer
status, network connection status, pulse beep status, power supply status, current time.

"Menu" button "Alarm" button "Review" button Network Power supply

Technical alarm event Printer Beep volume System time

 "Menu" button: enters into system menu dialog.

 "Alarm" button: enters into alarm setting dialog.

 "Review" button: enters into data review dialog.

 Technical alarm event: displays the current detected technical alarm event. Detailed technical alarm information
see Section Alarm.

 Icons of printer status (optional): there are 3 printer status as below:

1. : it means the printer is ready;

2. : it means the printer error caused by no paper or malfunction;

3. During printing, the printer displays status ( , , ) showing that the printer is working.
Move the cursor on this icon can enter into Printer Settings.

Note:

If your monitor is not configured with Printer, then the icons will not be shown up.

 Network connection status: there are 3 status ‐‐‐ " " means network connected; " " means network
disconnected; " "(with a moving point) means network is connecting, if the network connection is lost, then
the device will try to connect to the central station every 2 minutes.

Move the cursor on this icon can enter into Network Settings.

 Pulse beep status: there are 2 status ‐‐‐ " " means pulse beep is enabled; " " means pulse beep is disabled.

Move the cursor on this icon can enter into Beep Volume Settings.

 Power supply status

" " means the battery is being charged;

" (one grid)/ (two grids)/ / / " indicates battery voltage;


" " means the device is powered by AC power supply.

" " means low battery voltage.

 System time: the current time running in the device.


21
Operator’s Manual for Patient Monitor

Note: operating key to move the cursor on statusbar and focus on the icon of printer, network, beep volume, power
supply, system time or on the information area, then the corresponding setting window pops up, that's, Printer setting
window, Network setting window, Beep volume setting window, power supply setting window, System time setting
window.

Popup window for Beep Volume setting

Popup window for Power Status

Popup window for Alarm Volume setting

 "Mute": select this option to turn off the beep sound, then the volume indicator stays on "0".

Note: if the customer purchased the monitor with configuration of “Alarm mute for spot check”, please refer to the
following description:

 "Alarm mute in spot‐check mode": select this option to turn off the alarm sound. In this status, any alarm sound
will be muted, and the alarm sound will not resume until the user manually set the alarm volume as non‐zero
status. Note: please be cautious of using this option. It's not reco0mmended to set the alarm sound volume as 0.

22
Operator’s Manual for Patient Monitor

Popup window for Alarm Volume setting‐‐‐for device optioned with “Alarm Mute” function

2.4.3 Parameter Area and Waveform Area


1) Parameter Area

Parameter area displays each parameter's value, unit and icon etc.. Move Navigation Knob to focus on a certain
parameter panel, the panel (such as ECG parameter panel shown in below figure) will be highlighted, then press the
Navigation Knob to enter into the corresponding parameter setting screen.

ECG panel: enter into ECG setting


window

SpO2 panel: quick to enter into


SpO2 setting window

NIBP panel: quick to enter into NIBP


setting window

Respiration panel: quick to enter


into RESP setting window

Temperature panel: quick to enter


into TEMP setting window

2) Waveform area

23
Operator’s Manual for Patient Monitor

Generally, waveform area in the current view displays the waveform, parameter label and other information.

2.5 Views Management


Press "Menu" button, and select “Views” item to enter into "Views" window.

Views selection (refer to the monitor you purchased)

 View others: if “View others” option is selected, then this monitor can view the patient information from other
bedside monitor via the central monitoring network system.

 Save Last View: Enable or disable “Save Last View” function. Select it means enable this function. If selected,
then the Monitor will save the last operating view as the default view when re‐start the Monitor. The factory
default is “enable” this function.

Activate Views (refer to the monitor you purchased)

Description:

24
Operator’s Manual for Patient Monitor

1) Switch views

 Select the view required to be the “Current View”, then, press "OK" button to confirm the selection.

2) Views settings

 Press "Settings" button to setup the view selected, where waveforms and parameters can be configured as you
like.

3) Activate views

 In “Views” window, pressing "Activate" button to enter the "Activate Views" window. Then, the operator can
choose the views to be activate or not, the optional views (the views can be activated) are General, Big Font, All
ECG Trace, NIBP List, OxyCRG and Short Trends. The inactivated views are display in grey.

 Only the activated views can be clockwise shifted by operating Display View Key.

25
Operator’s Manual for Patient Monitor

Chapter 3 Operating Instructions


3.1 Installation
 Devices connected to the equipment must meet the requirements of the applicable IEC standards. The system
configuration must meet the requirements of the IEC 60601‐1‐1 medical electrical systems standard. Any
personnel who connect devices to the equipment’s signal input/output port are responsible for providing
evidence that the safety certification of the devices has been performed in accordance with IEC 60601‐1‐1. If
you have any question, please contact the manufacturer or your local dealers.

 If it is not evident from the equipment specifications whether a particular combination with other devices is
hazardous, for example, due to summation of leakage currents, please consult the manufacturers or an expert
in the field, to ensure the necessary safety of patients and all devices concerned will not be impaired by the
proposed combination.

 The equipment shall be installed by personnel authorized by manufacturer.

☞ The software copyright of the equipment is solely owned by the manufacturer. No organization or individual
shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any
means without due permission.

3.1.1 Unpacking and Checking

1. Open the package, take out the monitor and its accessories from the box carefully and place it in a safe, stable
and easy to watch position.

2. Open the user manual to sort the accessories according to the packing list.

 Inspect the accessories for any mechanical damages


 Check all the exposed leads and inserted accessories
 Check whether any risk or abnormity exists in the device and its accessories before using the monitor. If
any abnormity (such as broken cable or crack of the enclosure etc.) is found, do not use with the device.
 When disposing of the packaging material, be sure to observe the applicable waste control regulations and
keep it out of children’s reach.

 Before use, please verify whether package is intact, especially for the single use accessories. In case of any
damage, do not apply to patients.

☞ Save the packing case and packaging material as they can be used if the equipment must be reshipped.
☞ The user can customize the module configuration by choosing necessary modules to meet your own needs.
Therefore, your monitor may not have all the monitoring functions and accessories.
Please contact the local dealer or our company in case of any problems. We will offer the best solution for your
satisfaction.

3.1.2 Environmental Requirements

The operating environment of the equipment must meet the requirements specified in this manual. Otherwise,

26
Operator’s Manual for Patient Monitor

unexpected consequences, e.g. damage to the equipment, could result.

The environment where the equipment is used shall be reasonably free from noise, vibration, dust, corrosive,
flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind
shall be left for convenient operation, maintenance and repair. Moreover, to maintain good ventilation, the equipment
shall be at least 2 inches (5cm) away from around the cabinet.

When the equipment is moved from one place to another, condensation may occur as a result of temperature or
humidity difference. In this case, never start the system before the condensation disappears.

3.2 Getting Started

3.2.1 Connecting to Power Source

1. Using AC Power Source


 Make sure that the AC power supply is (100‐240) VAC, 50Hz/60Hz.

 Use the power cable provided by the manufacturer. Insert one end of it to the AC power input of the
monitor and the other end to the three‐pin outlet of the power source with protected‐earth.

 To eliminate potential differences, the monitor has a separate connection to the equipotential grounding
system. Connect one end of the provided ground wire to equipotential grounding terminal on the rear of the
monitor, and connect the other end to one point of the equipotential grounding system.

Caution:

1. Ensure that the monitor is grounded correctly.


2. If you have any doubt to the grounding layout and its performance, you must use the built‐in battery to
power the monitor.

 After the mains power supply has been interrupted while power switch remains in the “on” status and is
restored after a period of time that is longer than 30 seconds, the monitor will run by the last settings when
restarting the monitor.

 The monitor is applicable to connect to the public mains power network.

2. Using Battery
The following steps should be followed to install the battery:
Step 1: open the battery cover;
Step 2: pull out the battery cable and connect it to the battery pack;
Step 3: push the battery pack into the battery compartment and lock it;
Step 4: close the battery cover.
Caution:

it’s better to recharge the battery after it is used up, and the charging time should be 12~15 hours long.
Battery life: Provided that a battery is new and fully charged, the minimal working time of the monitor with
accessories connected is declared in the table below:

Name Battery life

27
Operator’s Manual for Patient Monitor

Patient Monitor More than 120min


NOTE:
When the device is working, it takes at least 10 hours to charge battery from empty state to 90% charged.
 The provided battery of the monitor must be recharged after transportation or storage. So if the monitor is
switched on without being connected to the AC power supply, it may not work properly due to insufficient
battery power.

: Working power supply indicator and the description is as shown below.

AC power Working power


Description
indicator supply indicator

On Off The monitor is powered by the AC power supply and it is in off status

Status Off On The monitor is powered by the built‐in battery power supply

The monitor is powered by the AC power supply and the battery is


On On
being charged

3.2.2 Turning the Monitor On

The system performs self‐test and enters initial display after the monitor is switched on, and the alarm rings to inform
the user that they can begin operating the monitor.

1. Check all the applicable functions to make sure that the monitor works normally.
2. If the built‐in battery is applied, please recharge it after using the monitor to ensure sufficient power storage. It
will take at least 10 hours to charge battery from depletion to 90% charge.
3. Press the Power on/off key on the front panel of the monitor to start the monitor.
 Do not use this device to monitor the patient if there are indications of damage or reminders of error. Please
contact the local dealer or our company.

 The battery powered monitor continues to run without interruption when AC mains power is lost.

 Start the monitor again 1 minute later after it is switched off. When the monitor is switched off allow one
minute before switching it back on so that the monitor powers off correctly.

3.2.3 Starting Monitoring

1. Decide which parameter measurements you want to make.

2. Connect the required modules, patient cables and sensors.

3. Check that the patient cables and sensors are correctly connected.

4. Check that the patient settings, such as Patient Type, NIBP measuring mode, etc, are appropriate to your
patient.

Refer to the corresponding Section for details of how to perform the measurements you require.

28
Operator’s Manual for Patient Monitor

3.3 Turning the Monitor Off


To disconnect the monitor from the power, follow this procedure:

1. Confirm that patient monitoring is complete.

2. Disconnect patient cables and sensors from the patient.

3. Make sure to save or clear the monitoring data as required.

4. Press the Power on/off key on the front panel to turn off the monitor.

 Although not recommended, you can press and hold the Power on/off key for 10 seconds to forcibly shut down
the monitor when it cannot be shut down normally. Please note that this may result in loss of data from the
monitor.

3.4 Using Keys

3.4.1 Shortcut Key

 , or View Settings Key: in view displaying screen (when there is no pop‐up

window on the screen), press this key, then the current View Settings window pops up on the screen. On setting a
certain parameter, pressing the navigation knob, and pressing View Settings window, then the shortcut keyboard
pops up on the screen.

 Alarm Reset Key: when alarm event occurs, press this key to reset this alarm, that means to mute the

alarm sound, but the visual alarming is still effective.

(Note: for the device optioned with Alarm Mute function, it is Alarm Silence Key: press this key to
pause or resume the alarm sound. )

 or Freeze/Keyboard Lock Key: press this key to freeze or unfreeze waveforms. The Display

View key and view setting key are disabled when waveforms are frozen. Long press this key can lock or unlock the
keyboard. When lock icon displays on the screen, a red lock icon will display on the left of "Menu" button. At this
time, other Shortcut Keys are disabled.

 or NIBP Key: press this key to start NIBP measurement, and during measurement,

pressing this key will pause NIBP measurement.

29
Operator’s Manual for Patient Monitor

 or Display View Key: press this key to shift the main screen when there is no pop‐up

window on screen. When a pop‐up window is on screen, this key will act as “Exit” (that is "Cancel" button on the
window.

 or Print Key: press this key to start or stop printing.

 or Navigation Knob: anticlockwise rotation acts as “Left‐arrow” key, clockwise rotation acts as

“Right‐arrow” key and press‐down acts as “OK” key.

Note: for the monitor configured with plugin module, pressing View Setting Key " " (or " ") can swiftly enter
into the corresponding setting window.

3.4.2 Buttons and Keyboard

The followed buttons would be used in a list box or waveform review.

1) Buttons in list box:

/ : previous/next row

/ : previous/next page of rows

/ : the last/first row

2) Frame or page moving buttons:

/ : the first/last page

/ : the precious/next page

Note:

In this monitor, functions of buttons above are similar. The contents will not be repeated in the later chapters.

3) Operation instruction for Soft keyboard

 If you want to input text in an edit‐box, navigate to that edit‐box and press the knob, then, a soft keyboard
window pops up→navigate to the letter you need, press down the knob to choose it.

 Press View Settings key , or to move the cursor to the upper row of the soft

30
Operator’s Manual for Patient Monitor

keyboard.

 " ": delete a letter.

 " ": press it or Views Display key or to exit with confirmation of the input in this time.

 " ": exit without confirmation of the input in this time, i.e. to cancel it.

4) Operation instruction for the often‐used key

"Default": press this button can default device settings, but you need choose "OK" on the pop‐up screen; choose
"Cancel", then the items in setup window will not be changed, and it will keep the settings saved in last time.

"OK": when you setup any items, choose "OK" button and press navigation knob to confirm the settings.

"Cancel": quit the current settings and save it without any changes.

Note:

The above buttons' function are similar to that in the following user manual, we will not repeat it in the later chapters.

3.5 Using the Touchscreen


We provide Touchscreen function for optional, therefore, touchscreen function may not be available for some of the
monitors which should be operated by keys.

3.6 Setting the Screens

31
Operator’s Manual for Patient Monitor

Generally, in general view screen, there are 3 to 7 traces of waveforms in the waveform area, and 2 to 7 parameter
panels in the parameter area. Each waveform trace shows specific signal waveform (eg. ECG waveform,
plethysmogram and so on), you can also disable this trace. Each parameter panel shows one or one group of
parameter value and the corresponding status.

Waveform area locates at the left part of screen. The display order of waveforms in a view is configurable. The default
order from up to down is waveform 1, waveform 2, waveform 3, waveform 4, waveform 5... waveform 7 (7 traces at
most).

Parameter panels locate at the right part of screen, the parameter order from up to down is Parameter 1, Parameter 2,
Parameter 3, Parameter 4... Parameter 7 (displays 7 parameter panels at most); the default order is ECG, SpO2, NIBP,
RESP, TEMP, IBP1 and IBP2.

You can allocate the positions of the parameter waveforms and panels. The parameters or waveforms whose positions
are not allocated will not be displayed.

If no corresponding parameter or waveform is displayed, you should perform the following inspections:

 Check the connection between the module and lead, cable, sensor, etc.

 Enter the Setup window for the corresponding display configuration.

3.7 Using the Main Menu


To enter the main menu by selecting the "Menu" button, most of the monitor’s operations and settings can be
perform through the main menu.

32
Operator’s Manual for Patient Monitor

Menu includes parameters setting and the entrances of other functions, such as ECG, SpO2, RESP/CO2, TEMP and NIBP
parameters setting, and the setting for optional function (e.g. CO2 setting, IBP setting, C.O. setting and CSM setting),
"Tourniquet", "Medicine Calculation", "Oxygenation", "Ventilation", "Renal Function", "System Settings", "Patient
information", "Color Settings" and “Standby” etc..

 Parameters settings window for ECG, SpO2, RESP, TEMP and NIBP; If some optional function is configured, then
the monitor will show the corresponding setting window (eg. IBP, C.O. CO2 and CSM setting window)
automatically on the "Menu" window.

 Functional window for Tourniquet, HEMO (hemodynamic calculation), Nurse Call, Medicine Dosage Calculation,
Oxygenation calculation, Ventilation calculation, Renal function and Patient Document;

 Device information window for System Settings, Color Settings and System Information.

Note: some of the above‐mentioned functions are optional, so your monitor may not cover all functions, please
refer to the monitor in your hand.

3.8 Changing System Settings


This Section covers only general settings, data and time, Network and Printer setting. Parameter settings and other
setting can be referred to in respective sections.

3.8.1 Changing General Settings

Changing Language
1. Select “Menu”→“System Settings”→“General”.

2. In “General” menu, select “Language” and then select the desired language.

3. Enter the required password.

4. Restart the monitor.

Notes:

1. The default required password in the monitor is “8989”.

2. The changed language is applied only after the monitor is restarted.

33
Operator’s Manual for Patient Monitor

Adjusting Volume
1. Alarm Volume

To set the alarm sound volume.

Step 1: Select “Alarm”→“Others”→“Alarm Volume”. Its setting range is "1 ~ 10", the step is 1. The default is 5. “10” is
the maximum volume. (Note: if your monitor is optioned “Spot‐check Mode” function, then the setting options
for Alarm Volume is “Spot Check”, “1~10”.)

2. Beep Volume

To set the pulse beep sound.

Step 1: Select “Menu”→“System Settings”→“General”.

Step 2: In “General” menu, select “Beep Volume”. Its setting range is "OFF", "0 ~ 10", the step is 1. The default is 5. If
you want to set the beep volume as "OFF", you need to enter the password. Attention: It's not recommended
to set it as OFF.

3. Key Tone

To enable or disable the keystroke sound and the touch‐screen sound.

4. Others

 Mode: monitor working mode selection. See Operating Modes.

 Freeze type: to select waveforms to be frozen on screen. The options are "All Waves", "EEG" and "ECG Waves".
When "ECG Waves" is selected, the system only freezes ECG waveforms. When "EEG" is selected, the system only
freezes EEG and EEG waveform. When "All Waves" is selected, the system freezes all waveforms on screen. The
default is "ECG Waves". On CSM view, it freezes EEG waveform. And when "All Waves" is selected, the EEG
waveform will be priority to be measured.

 Param font: to select parameters' digit font, there are 2 options: Bold Digit and Serif Digit.

 Plethysmogram: the switch to turn on or off the filled waveform style for plethysmogram display. When it is ON,
the monitor displays filled waveform for plethysmogram, otherwise, displays in simple curve style. The default is
OFF.

Note: this function is not available for ECG waveform.

 Beep volume: to set the pulse beep sound. Its setting range is "OFF", "1 ~ 10", the step is 1. The default is 5.
Attention: It's not recommended to set it as OFF.

 Pitch Tone: to choose the style of pitch tone, the pitch tone means the tone of pulse beep (from ECG or Oximetry)
changes when the measured SpO2 value changes, the higher SpO2 value, the sharper beep sound (high‐pitch).
Two options: “Mode I” and “Mode II”. The difference between Mode I and Mode II is the tone frequency at the
same SpO2 value. The factory default setting is “Mode I”.

 Screen brightness: to set the brightness of LCD backlight, 3 levels (1, 2and 3) for optional (note: for some specific
module, only 2 levels for optional, that’s “1” and “2”), the factory default is level 1. Level 1 is darker. (Note: this
function is only available for Series III and Series IV.)

 Key backlight: to turn on/off key backlight for the device, the factory default is “On”. (Note: this function is only

34
Operator’s Manual for Patient Monitor

available for Series III and Series IV.)

 Beat priority: to set the priority of the source of beat pulse beep and heart beat rate display value, there are 2
options: HR and PR. The factory default is “HR”.

When beat priority is selected to be “HR”, then the ECG panel displays the current measured heart rate value, and
generates the pulse beep, which are extracted from ECG signal when the heart beat is detected. If the heart rate can
not be obtained, or no heart beat is detected, then the ECG panel shifts to display pulse rate extracted from oximetry
signal, and pulse beep also comes from this source.

When beat priority is selected to be “PR”, then ECG panel displays the current measured pulse rate value, and
generates the pulse beep, which are extracted from oximetry signal, when the pulse beat is detected. If pulse rate
value can not be obtained and no pulse beat is detected, then the ECG panel shifts to display heart rate extracted from
ECG signal, or pulse beep also comes from this source. Even if the pulse rate value is displayed while the priority of PR
is set, if the heart rate value, which is not displayed, exceeds the preset high/low alarm limits, the alarm will still be
activated and alarm event will be recorded.

The ECG panel will shift to display the high/low alarm limit setting range automatically corresponding to the displayed
heart rate or pulse rate value.

 Use the last patient info. When power on: tick it means that the patient document of the last time will be used
as the Current Patient Document when powered on, i.e. the patient is not changed. Otherwise, system will use
the Default Patient Document (PID:0000000, Noname) as the Current Patient Document when powered on.

 Touchscreen Calibration (optional): to enter into touchscreen calibration window. There are 5 cross cursors " "
on the screen, tab the cross point " " of the 5 cross cursors with the stylus respectively to finish the calibration.

3.8.2 Setting the Date and Time

Step 1: Select “Menu”→“System Settings”→“Date/Time”.

 Month/Day/Year/Hour/Minute/Second: to set system date and time.

 Date format: to set date format of the system. There are 4 options: "YYYY‐MM‐DD", "YYYY.MM.DD",
"MM/DD/YYYY", "DD/MM/YYYY".

 Current time: to refresh the current system time.

3.8.3 Network Settings

Select “Menu”→“System Settings”→“Network”.

 Server IP Address: the IP address used to connecting a central monitoring system server (work station) .

 Port: the port number to which the monitor will connect to the work station in the central monitoring system. Its
setting range is from 6001 to 6064. It can also be used to represent the patient bed number connecting to the
work station. For example, the port number means the monitor is assigned to the bed number 2 in the CMS. Our
work station can connect to up to 64 bedside monitors, so please set the port between 6001and 6064. Press "OK"
to make the new setting effective.

 HL7 Protocol: enable or disable the monitor to export data to CIS/HIS by HL7 protocol. Select it means enable
HL7 protocol. The default is “enabled” HL7 protocol.
35
Operator’s Manual for Patient Monitor

 Local IP Address: the local IP address for the device.

 Subnet Mask: when the user selects a static IP address, then the subnet mask should be set. The default subnet
mask is “255.255.255.0”.

 Gateway: when the user selects a static IP address, then the gateway should be set. The default gateway is
“192.168.168.1”.

 Obtain IP Address Automatically: (when the remote server supports DHCP service) select it means the IP address
can be automatically configured by DHCP service. The device will perform DHCP configuration on every device
booting and/or network topology change. If select “Obtain IP Address Automatically”, then “Local IP Address”,
“Subnet Mask” and “Gateway” are in grey and nonadjustable.

Notes:

1. If DHCP fails (that’s to say, no DHCP server or no network is connected), then the IP address will be changed as

“0.0.0.0”, and the network icon “ ” will be displayed on the lower right of the screen. If IP address is
automatically configured by DHCP successfully, then the IP address will be displayed and network icon will be

changed as “ ”.

2. If the network is disconnected later after a successful DHCP configuration (for example, network cable is
detached), then the IP address will be changed as “0.0.0.0”. When the network connection is recovered, the
monitor will obtain IP address automatically again.

 Disable Network: enable or disable the network function. Select it means the network is disabled. The default is
"disabled" network function.

Notes:

1. Make sure that Central Server and the monitor are located in the same network segment. Every monitor
should have its unique Port Number. Otherwise, its network connection will be failed anytime.

2. The icon “ ” on the lower right corner of screen displays the network status.

3.8.4 Printer Settings

Select “Menu”→“System Settings”→“Printer”.

 Speed: the printer sweep speed. Options are 25mm/s and 50mm/s. The default is 25mm/s.

 Wave 1: print the first channel of waveform. Optional are: "ECG I", "ECG II", "ECG III", "ECG aVR", "ECG aVL", "ECG
aVF" and "ECG V" (that's ECG lead I~V). The default is ECG II. If "3‐lead wires" is selected, then this item is in grey
and nonadjustable. The first channel of waveform displaying on the current ECG window will be the first
waveform that the device will print (it can be set by Menu→ECG→Lead). The default is ECG lead II.

 Wave 2: print the second channel of waveform. If "5‐lead wires" is selected, then the optional will be: OFF, "ECG
I", "ECG II", "ECG III", "ECG aVR", "ECG aVL", "ECG aVF", "ECG V". If "3‐lead wires" is selected, then the optional
will be: "OFF", "PLETH" and "RESP". The default is OFF.

 Wave 3: print the third channel of waveform.

36
Operator’s Manual for Patient Monitor

Note:
The setting for Wave 1, Wave 2 and Wave 3 should be different (eg. Wave 2 and Wave 3 can not be set as "ECG
III" at the same time). Only 2 ECG waveforms at most can be printed simultaneously.
 ARR Trigger: ARR triggered printing. “ON” means the printer will print out waveform once an ARR event occurs.
The default is “OFF”.

 Duration: the duration of printing real‐time waveform. Options are: 10, 20, 30, 40, 50, 60 (seconds), and
Continuous, the default is "10" seconds. If "Continuous" is selected, then the printer will not stop printing until
manual stop it by pressing the print key.

 Print ECG Grids: the switch for grids on printed ECG waveform. Select it means the 5x5(mm2) grid background will
be printed when printing the ECG waveform.

 Timer: the switch for print timer. The default is “OFF”. If Print is ON, rotate navigation knob to set on the Timer to
enable timed print, and set the value of printing intervals in the cycle category. The setting range is 5~480
minutes, the step is 5 minutes. The default is 60 minutes.

 CSM (optional): select the CSM parameter, options are "EEG" and "Trend" that means the corresponding
electroencephalogram and graphic trend will be printed respectively.

3.9 Operating Modes

3.9.1 Real Time Mode

The "Real Time" shows the normal work mode with real time waveform and data.

3.9.2 Demo Mode

The "Demo" mode shows the demo working mode with simulated waveform and data. In the "Demo" mode, all the
signals and data are generated by the device for demonstrating and test purpose (the alarm function can be checked
in this mode).

 The Demo mode is for demonstration purpose only. To avoid stimulated data being mistaken for a monitored
patient’s data, you must not change into Demo mode during monitoring. Otherwise, improper monitoring and
delayed treatment could result.

3.9.3 Standby Mode

Select “Menu”→“Standby”.

In Standby Mode, you can temporarily stop monitoring without turning off the monitor. Click any key can exit from it.
If your monitor is configured with touchscreen function, then touch any point of the screen can exit from Standby
Mode.

37
Operator’s Manual for Patient Monitor

Chapter 4 Patient Data Management


Select “Menu”→"Patient Info.".

In the Patient Info. window, the operator can add, edit, delete and apply a patient's document as the current
document for monitoring.

4.1 Apply an existed patient’s document


Select “Menu”→"Patient Info."→"Apply".

If there is an existing patient document for the patient needing to be monitored, it is unnecessary to create a new
document for him. You can press “Apply” button to make the existed document as the “Current Patient’s Document”.

4.2 Create a new patient’s document


Select “Menu”→"Patient Info."→"Create".

To input characters at an edit‐box, press the Navigation Knob (same as “Enter” key), then the soft keyboard will pops
up immediately.

The following items need to input:

 PID: the Patient ID.

 Group: 3 types patient: Adult, Pediatric and Neonate. The default is "Adult".

 Adult: age > 12 years;


 Pediatric: 1 month < age ≤ 12 years;

 Neonate: age ≤ 30 days.

 First Name: patient first name.

 Last Name: patient last name.

 Gender : patient gender.

Important notes: When power on the monitor or the patient type is changed (e.g. the patient type changes from
"Adult" to "Neonate"), then the monitor performs initialization. Therefore, please confirm that the patient type
matches the patient to be monitored before monitoring. When “Pediatric” or “Neonate” is set to an adult patient, it is
difficult to get a valid NIBP measurement value and easy to make false alarms. It's forbidden to use the “Adult” mode
on a pediatric or neonate patient, for it may cause serious injury.

4.3 Edit a patient document


Select “Menu”→"Patient Info."→"Edit".

To edit a patient document requires the corresponding password, details see Section 3.9. In "Patient Info" window,
pressing "Edit" button, and if the password is entered correctly, then "Edit Patient Info." window pops up on the screen.
The item in grey is nonadjustable.

Note: no password is needed to edit the default patient document. In the default patient document, only the patient
type can be modified, and other items are not editable.

38
Operator’s Manual for Patient Monitor

4.4 Delete a patient document


Select “Menu”→"Patient Info."→"Delete".

To delete a patient document requires the corresponding password.

Notes:

1. When a patient document is deleted, all his corresponding records (ECG waveforms, ARR events, Alarm events,NIBP
list etc.) will be deleted and can not be recovered.

2. The system prohibits to remove the default patient and the current patient documents.

4.5 Exporting Data

4.5.1 Exporting Data from Monitor to a USB Driver

Note: USB data exporting function is available for the monitor with Plug‐in module (Series II), Series III and Series IV.

Connect the USB disk (stick memory) to the USB data interface on the rear panel of the patient monitor marked
“ ”.

Select “Preview”→”Export” to bring up the data exporting window, the plugged USB disk will be identified
automatically and displayed on the first line in the pop‐up window. (note: if no USB disk is detected, then “Refresh”,
“Export”, and “Unmount” buttons are displayed in grey and unavailable).

 : Select the USB disk from the drop‐down list.

 Refresh: Refresh the USB disk(s) enumeration.

 Export: Export the data and information for the selected patient

 Unmount: Unmount (remove) the selected USB disk from the system.

 Exit: Exit from the current window.

Press the drop‐down list ” ” to display all plugged USB disks, select one USB disk you want to export the data, then
press “Export” to start exporting. If data is exported successfully, then the window shows “Exported Successfully”, and
press “Close” to return to disks information displaying window.

Description:

: indicates the unused memory / total memory. If the USB disk memory is not enough, then the data
will fail to be exported.

: “KRK” indicates the data is exported to a file folder named “KRK” in the USB disk;
“20130101” is the time of this exporting; and “00000000” is the patient ID. The data for selected patient will be stored
with the file name of “20130101_00000000” under the file folder “KRK” in the USB disk.

39
Operator’s Manual for Patient Monitor

 Do not unplug the USB disk from the monitor during exporting, or the exported data will be in disorder, and
the history record files will be corrupted.

 Do not unplug the USB disk from the monitor before it is unmounted, or the data in the disk will be corrupted
or lost.

☞ If you need to review and manage the exported data, you can contact your local sales for address to download
the corresponding PC software (Patient Monitor Data Manager) for data management.

4.6 Connecting to a Central Monitoring System


If your monitor is connected to a Central Monitoring System (CMS):

 All patient information, measurement data and settings on the monitor can be transferred to the CMS.

 All patient information, measurement data and settings can be displayed simultaneously on the monitor and
CMS.

 For some functions such as editing patient information, admitting a patient, starting/stopping NIBP
measurements, etc., bi‐directional control can be achieved between your monitor and the CMS.

For details, refer to the CMS’s instructions for use

40
Operator’s Manual for Patient Monitor

Chapter 5 User Screens


5.1 Tailoring/Setting Your Screens
You can tailor your monitor’s screens by setting:

 Background theme and color in which each measurement’s numerics and waveform are displayed.

 Display Views

5.1.1 Changing the Display Theme

Select “Menu” →“Color Settings”.

Press "Details", then the color setting window for each parameter will pop up.

 Principal: to enter into the setting form for parameter and number. 112 kinds of color for option with code 0~111,
one code indicates one color.

 Theme: to select the monitor's color theme, options are: Space background, Sky blue, International fashion, and
Bamboo lands in China.

 Param BKG Color A and B: set the background color in parameter panels. Using color A and color B as the
parameter's background color displayed by turns. The default setting for A and B is 0. The setting range is from 0
to 85, one number indicates one color. If the background color for the first parameter panel is color A, then the
second parameter panel will be color B, and third will be color A again, alternately displayed in this way.

1) Quick Color Settings:

In the drop‐down box “ ” to select


the different theme, so as to change colors of all items in a view. Options are: Space background, Sky blue,
International fashion, and Bamboo lands in China.

5.1.2 Changing the Color of Waveforms and Parameter

1) Parameter Number Color Settings:

To set the parameter (ECG, S‐T, SpO2, RESP, TEMP and NIBP etc.) information and the waveform color. Procedures are:
Locate the cursor on the color box, rotate the Navigation Knob, and select the color.

The ECG color setting for theme, waveform and number: setting range is 0~111, the default is 16.

The S‐T color setting for number: setting range is 0~111, the default is 14.

The SpO2 color setting for theme, waveform and number: setting range is 0~111, the default is 2.

The RESP color setting for theme, waveform and number: setting range is 0~111, the default is 108.

The TEMP color setting for number: setting range is 0~111, the default is 111.

The NIBP color setting for number: setting range is 0~111, the default is 28.

41
Operator’s Manual for Patient Monitor

The CO2 color setting for number: setting range is 0~111, the default is 108.

The CSI color setting for number: setting range is 0~111, the default is 64.

The EMG color setting for number: setting range is 0~111, the default is 12.

The SQI color setting for number: setting range is 0~111, the default is 0.

The BS color setting for number: setting range is 0~111, the default is 91.

5.2 Display Views


A View can be configured in its Settings Window. To enter into the View Settings window for a certain view, the
procedure is: in the default screen, move the Navigation Knob on "Views" button, and select one of the view's label
(e.g. "Big Font"), press "Settings", then this view setting window (e.g. "Big Font View Settings" window) pops up on the
screen.

Another way to enter the View Settings window is: when the specified view is the “Current View” on screen, then
press "View Setting key" to enter into the view settings window directly.

Select “Views” button to enter into "Views" window.

This monitor provides the following display views:

 General view: meets most monitoring needs;

 Big Font view: displays the important parameters in the big font for remote observation;

 All ECG Trace view: emphasizes on all ECG waveforms;

 NIBP List view: emphasizes on NIBP data;

 RESP‐oxy view: emphasizes on SpO2 and Respiration data;

 Short trends view: displays waveforms and parameters together with recent 2‐hours parameter trend graph.

In a View Settings window, “Wave K” means “Waveform Channel No. K”, and “Param K” means “Parameter Panel No.
K”(K=1,2,…7), e.g. “Wave 2” is “Waveform Channel No. 2”, and “Param 3” is “Parameter Panel No. 3”.

5.2.1 General View

When power on the monitor, it enters into the defaulted General View screen. (Please refer to the monitor you
purchased) There are 5 traces of waveform in the left view: waveform for ECG lead III, ECG lead I, ECG lead II, SpO2
plethysmogram and Respiration; And there are 5 panels in the right view: ECG, SpO2, NIBP, RESP and TEMP.

1) Description:

 General View screen shows data and waveforms of main parameters.

 Generally there are 5 traces of waveform in waveform area. The default first trace is the waveform for ECG lead II;
The second is the waveform for ECG lead III; The third is the waveform for ECG lead I; The forth is the waveform
for SpO2 plethysmogram; And the fifth is the waveform for Respiration. The user can change it freely.

 Generally there are 5 parameter panels. The default panel order from up to down is: HR, TEMP, NIBP, SpO2, RESP
(or CO2) and CSM and so on.
42
Operator’s Manual for Patient Monitor

2) General View Settings:

 Waveform Settings:

Settings of waveform channels and parameter panels can be changed easily. Wave 1, Wave 2 and Wave 3 can be set
as any ECG lead, or turn off this channel directly.

If "3‐lead wires" is selected, it is nonadjustable and fixed to be the current displayed cascaded waveform, it can be set
by Menu→ECG→Lead to change the current displayed ECG waveform (we will not cover it again). The default is "ECG
II".

Note: if "3‐lead wires" is selected, then in all view settings (including general view, big font view, all ECG trace view,
NIBP list view and so on), the user can only be set it as the current displayed ECG waveform (that's "ECGII", "ECGI" and
"ECGIII").

If check box "Cascaded above" is checked, Wave 1, Wave 2 and Wave 3 will display the same signal channel as the
trace in a cascaded way.

Wave 4 and Wave 5 can be set as "OFF", "SpO2", "RESP", "CO2" and "CSM".

 Parameter Settings:

 Parameter 1 and 2 is fixed to be ECG and SpO2 respectively, which can not be adjusted. Parameter 3 to 7 can be
set as OFF, TEMP, NIBP and RESP and so on.

Note: waveform 1~5 and Parameter 1~5 are corresponding to the waveform 1~5 and Parameter 1~5. Similarly, in other
views, the waveform 1~5 and Parameter 1~5 corresponds to that in View settings window, we will not cover it later.

5.2.2 Big Font View

43
Operator’s Manual for Patient Monitor

1) Description:

In this view, the default 3 waveform channels in the waveform area are ECG waveform, SpO2 plethysmogram and RESP
waveform. And the default 4 parameter panels in the parameter area are the ECG Panel, SpO2 Panel, NIBP Panel and
RR panel.

2) Big Font View Settings

 Waveform Settings:

 Wave 1 can be set as any ECG lead, or turn off this channel directly.

 Wave 2 and Wave 3 can be set as OFF, ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF, ECG V, SpO2, and RESP (or
CO2). If "3‐lead wires" is selected, then Wave 2 and Wave 3 can be set as SpO2, and RESP (or CO2), or set as the
current cascaded ECG waveform (e.g. ECGII).

 Parameter Settings:

 “Param 1”, “Param 2” and “Param 4” can be set as OFF, ECG, SpO2, NIBP, TEMP and RESP (or CO2) and so on.

 “Param 3” can be set as ECG, TEMP, NIBP, SpO2 and RESP (or CO2) and so on.

 Cascaded above: select it means all first 3 channels waveform display the waveform set in Waveform 1, and
waveform 2 and waveform 3 are the cascaded waveform of Waveform 1. And at the moment, Wave 2 and Wave 3
are nonadjustable. The default is deselect it.

 Close all waveforms: select it means the waveform 1 to waveform 3 will not be displayed on the waveform panel
in the big font view, but the information in parameter panel will be displayed.

5.2.3 All ECG Trace view

1) Description:

In this View, all ECG trace waveforms are displayed on screen simultaneously. All 7 traces of ECG waveform are
displayed on the left, and the 5 parameter panels are on the right.

2) All ECG Trace View Settings:

The default 7 waveforms displaying in the view are: ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF and ECG V,
waveform 1~7 are nonadjustable. When "3‐lead wires" is selected, then it displays the cascaded waveform, the
cascaded waveform is fixed to be "ECG II", "ECG I" or "ECG III".

 Parameter 1 and Parameter 2 are nonadjustable, the default settings are ECG and SpO2 respectively.

 Parameter 3 to Parameter 5 can be set as OFF, TEMP, NIBP, RESP (or CO2) and so on.

 All waves: select this item, then all waveforms (including all ECG waveforms and other waveforms) will be
displayed on ECG trace view. The factory default is un‐select.

Note: if your monitor is configured with 12‐leads ECG function, then in All ECG Trace View Setting window, you can
select or un‐select “Cabrera”. When “Cabrera” is selected, then the waveform sequence of ECG lead will be aVL, I, aVR,
II, aVF, III and V1~V6. When un‐select “Cabrera”, then the waveform sequence of ECG lead will be I, II, III, aVR, aVL, aVF
and V1~V6.

44
Operator’s Manual for Patient Monitor

5.2.4 NIBP List view

1) Description:
In this View, 4 waveform channels are default to be ECG I, ECG II, ECG III and SpO2 plethysmogram. Parameter panels in
the parameter area are default to ECG, SpO2, NIBP, RESP and TEMP. At the same view, the NIBP list view will be
displayed.

2) NIBP List View Settings:


 Waveform 1 can be set as OFF, ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF and ECG V.

 Waveform 2 and 3 can be set as OFF, SpO2, RESP (or CO2). The default is ECG II for Wave 1, SpO2 for Waveform 2
and RESP (or CO2) for Waveform 3.

 Waveform 4 is nonadjustable, the default is NIBP List.

 Parameter 1 and 2 are nonadjustable, the default is ECG and SpO2 respectively.

 Parameter 3 ~ 5 can be set as OFF, NIBP, RESP, TEMP, CO2 and CSM etc.

5.2.5 OxyCRG view

1) Description:

In this View, the upper 3 waveform channels are default to ECG II, SpO2 and RESP. The lower area of the waveform
area is Oxycardiorespirogram, which consists of HR trend graph, SpO2 trend graph and Respiration waveform or RR
trend graph within certain time scale. In "OxyCRG View Settings" window, the time scale and the 3rd graph can be
changed as needed (refers to the following section). Settings of the parameter area are similar to that in “General
View”.

2) OxyCRG Settings:

 Waveform 1 can be set as OFF, ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF and ECGV.

 Waveform 2 and 3 can be set as OFF, SpO2 and RESP (or CO2).

 The time scale for OxyCRG can be set as 1min, 2min or 4 min. Min is the time unit of "Minute".

 The 3rd graph in OxyCRG can be set as “RR Trend” or “Resp Wave”.

 Parameter 1 and 2 are nonadjustable, the default is ECG and SpO2 respectively.

 Parameter 3 ~ 5, or Parameter 7 can be set as OFF, TEMP, NIBP, RESP, CO2 and CSM etc.

5.2.6 Short trends view

1) Description:

In this view, several waveform channels can be displayed on waveform area. Trend graphs are on the middle of screen.

The abscissa of trend graph (‐2h ‐0) means various trend of every parameter value from now on to 2 hours before. The
panels of HR, SpO2, TEMP, RESP. NIBP and IBP are displayed on parameter area.

2) Short Trends View Settings


45
Operator’s Manual for Patient Monitor

 Waveform 1 to 3 can be set as OFF, ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF, and ECG V.

 Waveform 4 to 5 can be set as OFF, SpO2 and RESP (or CO2) and so on.

 Trend 1 is nonadjustable, the default is HR.

 Trend 2 ~5 can be set as OFF, TEMP, SpO2, RR and S‐T and so on.

 Parameter 1 and 2 are nonadjustable, the default is ECG and SpO2 respectively.

 Parameter 3~5 can be set as OFF, TEMP, NIBP and RESP (or CO2) and so on.

5.2.7 CSM View

1) Description:
In this view, the default waveform in the 4th channel is for CSM related. The default in parameter 1, 2 and 5 are ECG,
SpO2 and CSI respectively. Other waveform traces and parameters area can be set by user, refer to the "CSM View
Setting" for details.
The EEG waveform, SQI/EMG%/CSI/BS% trend graph and event mark can be displayed on CSM waveform area, the
EMG% real‐time bar graph will be displayed as well. In above figure, "80" is the amplitude scale for EEG, "‐04.00 ‐03.00
‐02.00 ‐01.00 ‐00:00" is the time scale for trend graph, and "0 20 40 60 80 100" is the scale for CSI value.

2) CSM View Settings


 Waveform 1 can be set as OFF, ECG I, ECG II, ECG III, ECG aVR, ECG aVL, ECG aVF, and ECG V.
 Waveform 2 to 3 can be set as OFF, SpO2 and RESP (or CO2) etc. The default is "SpO2" and "RESP" respectively.
 Waveform 4 is nonadjustable, the default is for EEG waveform and SQI/EMG%/CSI/BS% trend graph.
 Parameter 1, 2 and 5 are nonadjustable, the default is ECG, SpO2 and CSI (Cerebral State Index) respectively.
 Parameter 3 and 4 can be set as OFF, TEMP, NIBP, RESP (CO2) etc.
 CSM only: click it to turn on or off the CSM monitoring screen. If you click it to turn on “CSM only” function, then
waveform 1~3, and parameter 1~4 are fixed to be “off” and nonadjustable. Waveform 4 and parameter 5 are
fixed for CSM related function.
If you turn on “CSM only” function, then, the CSM view only displays EEG waveform, trend graphs and parameters of
CSI, EMG%, SQI and BS%, as shown in below figure.

46
Operator’s Manual for Patient Monitor

47
Operator’s Manual for Patient Monitor

Chapter 6 Alarms
Alarms, triggered by a vital sign that appears abnormal or by technical problems of the monitor, are indicated to the
user by visual and audible alarm indications.

6.1 Alarm Categories


By nature, the monitor’s alarms can be classified into three categories: physiological alarms, technical alarms and
prompt messages.

1. Physiological alarms

Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set
alarm limits or an abnormal patient condition. Physiological alarm messages are displayed in the physiological alarm
area.

2. Technical alarms

Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion
due to improper operation or mechanical problems. Technical alarm messages are displayed in the technical alarm
area.

3. Prompt messages

Prompt messages are not alarm messages. Apart from the physiological and technical alarm messages, the monitor
will show some messages telling the system status or patient status. Messages of this kind are included in the prompt
message category and usually displayed in the prompt information area. Some prompt messages that indicate
arrhythmia events are displayed in the physiological alarm area. For some measurements, their related prompt
messages are displayed in their respective parameter windows.

6.2 Alarm Levels


By severity, the monitor’s alarm can be classified into three categories: high level, medium level and low level. In
addition, the monitor has preset alarm levels about physiological alarm and technical alarm.

48
Operator’s Manual for Patient Monitor

Physiological alarm

Alarm priority Alarm


Alarm Event
level Source
ECG Unable to detect HR, ECG Arrest, ECG Brady, ECG Tachy, VE RUN, SVE RUN, HR is
too high, HR is too low, S‐T is too high, S‐T is too low, VE Run, ECG VPCEST
SpO2 Unable to detect SpO2, SpO2 too high, SpO2 too low, PR too high, PR too low
Respiration Apnea, RR too high, RR too low
High Temperature
Temp1 too high, Temp1 too low, Temp2 too high, Temp2 too low, TD too high

NIBP NIBP SYS too high, NIBP SYS too low, NIBP DIA too high, NIBP DIA too low, NIBP
MAP too high, NIBP MAP too low, PR too high, PR too low
CO2 RR too high, RR too low, EtCO2 too high, EtCO2 too low, InsCO2 too high, InsCO2 too
low
CSM CSI is too high, CSI is too low
ECG VE RonT, SVE RonT, S‐T1 too high, S‐T1 too low, S‐T2 too high, S‐T2 too low, S‐T3
Medium too high, S‐T3 too low, S‐T4 too high, S‐T4 too low, S‐T5 too high, S‐T5 too low,
S‐T6 too high, S‐T6 too low, S‐T7 too high, S‐T7 too low
ECG Miss Beat, VE Early, SVE Early, VE Couplet, SVE Couplet, VE Short Run, SVE Short
Low Run, SVE Run, VE Insert, SVE Insert, VE Bigeminy, SVE Bigeminy, VE Trigeminy, SVE
Trigeminy, Multiform Beat

Technical alarm
Alarm priority Alarm
Alarm Events
level source
System Low battery, SpO2 modular malfunction, Unknown error
High
CO2 CO2 sensor failed, CO2 sensor temperature is too high
Lead(s) off, SpO2 Probe off, SpO2 value exceeds measuring range, HR exceeds
ECG/SpO2
measuring range
CO2 sensor off, need to perform zero resetting, CO2 over detect value, check air
Medium adapter, check sampling tube, CO2 zeroing failed.
CO2
Zeroing information (like “Zeroing starting”, “Zeroing successful”) appears on the
window
IBP IBP1 Probe off, IBP2 Probe off, IBP3 Probe off, IBP4 Probe off
Self‐test failed, System error, Over time, Signal weak, Cuff error, Air leakage,
NIBP Pressure error, Out of range, Too much motion, Over pressure, Signal saturation,
Low Detected air leakage, BP exceeds measuring range,
TEMP Temperature self‐detect failed, TEMP1/TEMP2 exceed(s) measuring range
CSM Electrodes off

Related to 3 levels alarm sources, medical and nursing staff should have different response to deal with potential
dangers, the detailed demands are as follows:

1. High priority alarm: medical and nursing staff should response immediately.

2. Medium priority alarm: medical and nursing staff should response quickly.

49
Operator’s Manual for Patient Monitor

3. Low priority alarm: medical and nursing staff should response as soon as possible.

NOTE:

Some models may have only Medium and Low alarm priority because of the different configuration.

6.3 Alarm Indicators


When an alarm occurs, the monitor will indicate it to the user through visual or audible alarm indications.

6.3.1 Alarm lamp

Lamp color Alarm level Alarm event

Red flashing High priority alarm ECG Brady, ECG Tachy, Low battery, Vital sign alarm

Yellow flashing Medium priority alarm Lead off, Probe off, Sensor off, VE RonT,SVE RonT

Yellow Low priority alarm Other Arrhythmia event

Green Normal

6.3.2 Alarm message

When an alarm occurs, an alarm message will appear in the technical or physiological alarm area. And the alarm
message is shown in different color to match the alarm level (high priority alarm in red, medium priority alarm in
yellow, and low priority alarm in white).

6.3.3 Highlighting Numeric

If an alarm triggered by an alarm limit violation occurs, the numeric of the measurement in alarm will be highlighted.

6.3.4 Audible Alarm Tones

The alarm tone is distinct from the heart beat tone, keystroke tone and pulse tone in frequency. The alarm tones
identify the alarm levels as follows:

 High priority alarm: beep+beep+double+beep+pause+beep+beep+double+beep

 Medium priority alarm: triple beep

 Low priority alarm: single beep

 When multiple alarms of different levels occur simultaneously, the monitor will select the alarm of the highest
level and give visual and audible alarm indications accordingly.

6.3.5 Alarm Status Symbols:

Apart from the aforementioned alarm indicators, the monitor still uses the following symbols telling the alarm status.

 For the customer purchased the monitor with configuration of “Alarm pause”, then this area shows the alarm
50
Operator’s Manual for Patient Monitor

sound status. There are 3 alarm sound status:

①" " means the alarm sound is enabled;

②" " means the alarm sound is disabled or means the alarm volume is 0 (alarm is mute), at this time the user
should pay more attention to the patient;

③" " means the alarm sound is paused. Text display area: when the alarm sound is paused, it displays

counting‐down time, otherwise it displays the date. Move the cursor on this text display area can bring up the edit box
of "Alarm volume" setting.

 For the customer purchased the monitor with configuration of “Alarm Reset”, then this area shows the alarm
sound status. There are 2 alarm sound status:

①“ ” means the alarm system keeps on (is on “Alarm activating status”), and when alarm event occurs, it

displays icon “ ”;

② When alarm event occurs, after pressing alarm reset key, then it displays icon “ ”. Move the cursor on this
icon can bring up the edit box of "Alarm volume" setting.

Remark:

 Alarm reset key: pressing this key can perform alarm reset for the current activated alarm event (that’s to

say, the audible alarming will be off, but the visual alarming still keeps effective), then icon “ ” displays on
the upper right corner of the screen. The monitor can response to a new alarm event during the alarm reset
status, that’s to say, both visual and audible alarming will be effective when there is a new alarm condition, and

the icon “ ” displays on the upper right corner of the screen at the same time. Alarm reset is not a toggle
operation, pressing this key once or more times only makes alarm reset.

 The description for technical alarm status indicator and physiological alarm indicator

1) Technical alarm status indicator is an auxiliary indicator for “Alarm lamp”. It’s used for indicating whether the system
in technical alarm status or not. When the system in technical alarm status, then the indicator in blue, otherwise, it
stays off.

2) When high priority physiological alarm event occurs, the physiological alarm indicator " " is flashing with red
color; when middle priority physiological alarm event occurs, the indicator is flashing with yellow color; when the low
priority physiological alarm event occurs, the indicator is in constant yellow light; if there is no physiological alarm
event, the indicator is in constant blue light.

51
Operator’s Manual for Patient Monitor

6.3.6 Changing Alarm Volume

To set the alarm sound volume.

Step 1: Select “Alarm”→“Others”.

Step 2: In “Others”, select “Alarm Volume”. Its setting range is "0 ~ 10", the step is 1. The default is 5. “10” is the
maximum volume.

 When the alarm sound is switched off, the monitor will give no audible alarm tones even if a new alarm occurs.
Therefore the user should be very careful about whether to switch off the alarm sound or not.

 Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level
may result in a hazard to the patient. Always keep the patient under close surveillance.

 Pausing or switching off alarms may result in a hazard to the patient, please be very careful.

 If occurrence of multiple alarm signal at the same time, the monitor will only show the high priority alarm in
the form of audible alarm and alarm lamp. Meanwhile, all alarm signals information including message
descriptions and numerical highlight etc. will be shown respectively and simultaneously on the screen.

 It is suggested that the users should not change the alarm volume lower than the factory default setting if
close and constant attention could not be paid to the patient, otherwise the negligence of alarm event might
cause irreversible harm to the patient.

 During the alarm silence period, any new alarm event can activate the audible alarm again and the audible
alarm function resumes normal state.

6.4 Understanding the Alarm Setting


Select “Alarm” button on Statusbar, and select parameter (such ECG, SpO2, NIBP, TEMP, etc.). You can review and set
alarm limits, alarm switches, high/low alarm limit, and alarm level for each parameter, as shown in below figure.

52
Operator’s Manual for Patient Monitor

Alarm setting window (for full configuration)

 General parameters: the general parameters include HR, SpO2, SpO2_PR, SYS, DIA, MAP, NIBP_PR, RR, S‐T, Temp1,
Temp2 and TD.

 HR: turn on or off over‐limits alarms of HR, set the high and low alarm limits, and set the alarm level. Setting
range See below Section. 3 alarm level for options: high, medium and low.

The operation for other parameters is similar to that of HR, and we will not cover it again.

 Previous page: click it to turn to previous page.

 Next page: click it to turn to next page.

 All on: select it to enable alarm function for all parameters. Password is required for this operation.

 All off: select it to disable alarm function for all parameters. Password is required for this operation, and it’s not
recommended to disable the alarm function completely.

Notes:

1.If the parameter alarm switch is set to “OFF”, then icon ” ” will be displayed on the corresponding parameter

panel. If the parameter panel has two or more related parameters, only all alarm switch for these related parameters

set as “OFF”, icon “ ” will be displayed on its parameter panel. For example, there are SYS, DIA and MAP for NIBP

parameter panel, only the alarm switch for SYS, DIA and MAP are set as “OFF”, then icon ” ” will be displayed on the

NIBP panel.

2.The high alarm limit for SpO2 is fixed to be “100” and is nonadjustable.

53
Operator’s Manual for Patient Monitor

 For the monitor configured with IBP, CO2, CSM, AG monitoring, then the alarm switch, high/low alarm limits, and
alarm level for these parameters can be set here.

 ARR: to set the alarm priority level for 5 arrhythmia (ARR) events, which include ECG Brady, ECG Tachy, ECG Arrest,
VE Run and SVE Run. 3 priority alarm level for option: high, medium and low. The user can also enable or disable
the alarm switch for these 5 ARR events.

 Others: to set the alarm volume and timeout setting for apnea alarm.

 Alarm volume: to set the alarm sound volume for the monitor. The setting range is “1~10” level, and the default
is 5. Note: for the monitor optioned with “Mute for Spot Check” function, the setting option is 1~10 and “Spot
Check”.

 Apnea: to set the timeout setting for apnea alarm (in seconds). The options are: off, 10, 15, 20, 25, 30, 35 and 40.
Details see Section “Changing RESP Settings”.

54
Operator’s Manual for Patient Monitor

6.4.1 High and Low Alarm Setting Range

Select “Alarm”→“General Parameter”.

Setting range
Parameter
High limit Low limit

HR(bpm) (Low limit+1)~350 0~(High limit‐1)

S‐T(mV) (Low limit+0.01)~2.50 ‐2.5~(High limit‐0.01)

SpO2(%) (Low limit+1)~100 0~(High limit‐1)

SpO2_PR(bpm) (Low limit+1)~300 0~(High limit‐1)

RR(rpm) (Low limit+1)~150 0~(High limit‐1)

TEMP1(℃) (Low limit+0.1)~60.0 0~(High limit‐0.1)

TEMP2(℃) (Low limit+0.1)~60.0 0~(High limit‐0.1)

TD(℃) 0.0~5.0

NIBP(Unit)mmHg Adult Pediatric Neonate

High limit (Low limit+1)~280 (Low limit+1)~200 (Low limit+1)~135


SYS
Low limit 29~(High limit‐1) 29~(High limit‐1) 29~(High limit‐1)

High limit (Low limit+1)~242 (Low limit+1)~165 (Low limit+1)~110


MAP
Low limit 20~(High limit‐1) 20~(High limit‐1) 20~(High limit‐1)

High limit (Low limit+1)~232 (Low limit+1)~150 (Low limit+1)~100


DIA
Low limit 10~(High limit‐1) 10~(High limit‐1) 10~(High limit‐1)

NIBP(Unit)kPa Adult Pediatric Neonate

High limit (Low limit+0.1)~37.3 (Low limit+0.1)~26.7 (Low limit+0.1)~18.0


SYS
Low limit 3.9~(High limit‐0.1) 3.9~(High limit‐1) 3.9~(High limit‐0.1)

High limit (Low limit+0.1)~32.3 (Low limit+0.1)~22.0 (Low limit+0.1)~14.7


MAP
Low limit 2.7~(High limit‐0.1) 2.7~(High limit‐0.1) 2.7~(High limit‐0.1)

High limit (Low limit+0.1)~30.1 (Low limit+0.1)~20.0 (Low limit+0.1)~13.3


DIA
Low limit 1.3~(High limit‐0.1) 1.3~(High limit‐0.1) 1.3~(High limit‐0.1)

55
Operator’s Manual for Patient Monitor

Note: The following parameters are optional

Setting range
Parameter
High limit Low limit

EtCO2 (Low limit+1)~160 0~(High limit‐1)


CO2 (mmHg)
InsCO2 (Low limit+1)~60 0~(High limit‐1)

ART (Low limit+1)~300 0~(High limit‐1)

PA (Low limit+1)~120 ‐6~(High limit‐1)

IBP CVP (Low limit+1)~40 ‐10~(High limit‐1)

(mmHg RAP (Low limit+1)~40 ‐10~(High limit‐1)

LAP (Low limit+1)~40 ‐10~(High limit‐1)

ICP (Low limit+1)~40 ‐10~(High limit‐1)

AUXP1 (Low limit+1)~300 50~299

AUXP2 (Low limit+1)~300 50~299

CSI (Low limit+1)~100 0~(High limit‐1)

EtCO2 (Low limit+0.1)~15 0~(High limit‐0.1)

Ins.CO2 (Low limit+0.1)~14.9 0~(High limit‐0.1)

EtN2O (Low limit+1)~100 0~(High limit‐1)

AG Ins.N2O (Low limit+1)~99 0~(High limit‐1)

(%) EtAA1 (Low limit+0.1)~15 0~(High limit‐0.1)

Ins.AA1 (Low limit+0.1)~15 0~(High limit‐0.1)

EtAA2 (Low limit+0.1)~15 0~(High limit‐0.1)

Ins.AA2 (Low limit+0.1)~15 0~(High limit‐0.1)

56
Operator’s Manual for Patient Monitor

6.4.2 Factory Default Alarm Limit Setting Value

Type
Adult Pediatric Neonate
Parameter

High limit 180 bpm 200 bpm 220 bpm


HR
Low limit 40 bpm 50 bpm 50 bpm
High limit 30 rpm 30 rpm 100 rpm
RR
Low limit 8 rpm 8 rpm 30 rpm
High limit 39 ℃ 39 ℃ 39 ℃
TEMP
Low limit 35 ℃ 35 ℃ 35 ℃
High limit 180 mmHg 130 mmHg 110 mmHg
SYS
Low limit 60 mmHg 50 mmHg 50 mmHg
High limit 120 mmHg 90 mmHg 90 mmHg
DIA
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 160 mmHg 110 mmHg 100 mmHg
MAP
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 100 % 100 % 100 %
SpO2
Low limit 90 % 85 % 85 %
High limit +1.00mV +1.00mV +1.00mV
S‐T segment
Low limit ‐1.00mV ‐1.00mV ‐1.00mV
High limit 50mmHg 50mmHg 45mmHg
EtCO2
Low limit 25mmHg 25mmHg 30mmHg
High limit 4mmHg 4mmHg 4mmHg
InsCO2
Low limit 0 0 0
High limit 180 bpm 200 bpm 220 bpm
PR
Low limit 40 bpm 50 bpm 50 bpm
TD 2℃ 2℃ 2℃
High limit 60 60 60
CSI
Low limit 40 40 40

High limit 200mmHg 160mmHg 140mmHg


ART
Low limit 10mmHg 10mmHg 10mmHg

High limit 120mmHg 100mmHg 90mmHg


PA
Low limit 10mmHg 10mmHg 10mmHg

High limit 30mmHg 30mmHg 30mmHg


CVP
Low limit ‐10mmHg ‐10mmHg ‐10mmHg

57
Operator’s Manual for Patient Monitor

High limit 30mmHg 30mmHg 30mmHg


RAP
Low limit ‐10mmHg ‐10mmHg ‐10mmHg

High limit 30mmHg 30mmHg 30mmHg


LAP
Low limit ‐10mmHg ‐10mmHg ‐10mmHg

High limit 30mmHg 30mmHg 30mmHg


ICP
Low limit ‐10mmHg ‐10mmHg ‐10mmHg

High limit 200mmHg 160mmHg 140mmHg


AUXP1
Low limit ‐30mmHg ‐30mmHg ‐30mmHg

High limit 200mmHg 160mmHg 140mmHg


AUXP2
Low limit ‐30mmHg ‐30mmHg ‐30mmHg

High limit 6.6%


EtCO2
Low limit 3.3%

High limit 0.5


Ins.CO2
Low limit 0

High limit 55
EtN2O
Low limit 0

High limit 53
Ins.N2O
Low limit 0
AG
High limit 3.0
EtAA1
Low limit 0

High limit 2.0


Ins.AA1
Low limit 0

High limit 3.0


EtAA2
Low limit 0

High limit 3.0


Ins.AA2
Low limit 0

1. Except volume of audible alarm can be adjustable, the other properties of the alarm cannot be adjusted by the user,
such as alarm priority setting, alarm lamp flashing and so on. In addition, all alarms in this patient monitor are
“non‐latched” type, that is to say, when the alarm event disappears, the corresponding alarm will automatically stop.
The alarm volume range is shown as below:

 High: 0dB~80dB (The distance between device front and test instrument is 1m)

58
Operator’s Manual for Patient Monitor

 Medium: 0dB~75dB (The distance between device front and test instrument is 1m)

 Low: 0dB~70dB (The distance between device front and test instrument is 1m)

2. Alarm settings are non‐volatile, that means the previous settings will still sustain even the patient monitor is
powered off including unexpected power failure and manual reboot.

6.5 Testing Alarms


When the monitor starts up, a self‐test is performed. In this case the alarm lamp will light, and the system gives a beep.
This indicates that the visible and audible alarm indicators are functioning correctly.

For further testing of individual measurement alarms, perform the measurement on yourself (for example SpO2 or CO2)
or enter Demo Mode, or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.

6.6 When an Alarm Occurs


When an alarm occurs, observe the following steps and take proper actions:

1. Check the patient’s condition.

2. Confirm the alarming parameter or alarm category.

3. Identify the source of the alarm.

4. Take proper action to eliminate the alarm condition.

5. Make sure the alarm condition is corrected.

59
Operator’s Manual for Patient Monitor

Chapter 7 ECG Monitoring


7.1 Introduction
The electrocardiogram (ECG) is primarily a tool for evaluating the electrical events within the heart. The ECG signals
can be detected by electrodes at the surface of the skin, this device connects ECG signals and represents them on the
monitor as waveforms and numerical value such as heart rate. The S‐T segment measurement and arrhythmia
detection can be done as well by the ECG signals.

The ECG electrodes connect the patient and the lead wires and/or ECG cable, the lead wires and/or cable connect to
the monitor. The electrode type selection and the locations of the electrodes are very important to ensure accurate
ECG measurement.

7.2 Safety Information


 This patient monitor can only be equipped with ECG cable and/or lead wires provided by the manufacturer;
using those from other suppliers may cause improper performance or poor protection while using defibrillator.

 Using the same type of qualified and authorized electrodes which should be within its effective life on the
same patient. If any side‐effect such as allergic or stimulus skin is found, the measurement should be stopped
at once. It is prohibited to apply the electrode to the patient with lesion and body putrescence.

 To the patient with pacemaker, normally the heart rate meter does not count the pacemaker pulse due to the
function of pacemaker pulse inhibition, but for the pacemaker with overshoot pulse, the inhibition function
may not be fully effective. So it is important to observe the ECG waveforms carefully and do NOT rely entirely
on the heart rate display and alarm system when monitoring the pacemaker patient.

 The improper connection with electro‐surgical unit may not only cause burns, but also damage the monitor or
arouse deviations of measurement. You can take some steps to avoid this situation, such as do NOT use small
ECG electrodes, choosing the position which is far away from the estimated Hertzian waves route, using larger
electro‐surgical return electrodes and connecting them with the patient properly.

 In operation mode, the monitor can be used with electro‐surgical unit. The monitor’s operator should ensure
the safety of the patients if in use with electro‐surgical unit in accordance with the instructions of this manual.
After the elimination of high frequency signal and high frequency electromagnetic field, the monitor can be set
to the previous operation mode within 10 seconds without losing any stored data.

 Do not use the monitor with electro‐surgical unit in non‐operation mode, nor with large‐scale electrical
equipment such as ultrasonic, radiation and magnetic resonance imaging, which may cause electromagnetic
interference to the monitor or harm the monitor’s operator.

 Conductive parts of electrodes, lead wires and cable are forbidden to contact any other conductive parts
(including ground).

 This patient monitor can resist against the discharge of defibrillator and the interference from the
electro‐surgical unit. Readings may be inaccurate for a short time after or during using defibrillator or
electro‐surgical unit.

 Transient caused by cable circuitry blocks while monitoring may cause artifact on ECG signals yielding wrong

60
Operator’s Manual for Patient Monitor

heart rate reading and even triggering false alarm. If the electrodes and cable are located in proper places
according to this manual’s instructions for using electrodes, the chance of this transient occurrence will be
decreased.

 ECG cable and/or lead wires may be damaged while using defibrillator. If the cable and/or lead wires are used
again, please do the functional check firstly.

 When the monitor is inoperable due to overload of ECG signal or saturation of any part of the amplifier, it will
prompt “Lead(s) off” to remind the operator.

 The user should ensure that no predictable hazard will be caused by the summation of leakage currents when
several items of monitor are interconnected.

 When plugging or unplugging the ECG cable, be sure to hold the head of the connector and pull it out.

7.3 Preparing to Monitor ECG

7.3.1 Preparing the Patient and Device

1. Skin preparation

The quality of ECG waveform displayed on the monitor is a direct result of the quality of the electrical signal received
at the electrode. Proper skin preparation is necessary for good signal quality at the electrode. A good signal at the
electrode provides the monitor with valid information for processing the ECG data. To ensure enough electrolyte
material on the skin of patients, you need to moisten the measuring sites with 70% isopropyl Ethanol. This will usually
be sufficient for ECG monitoring for a short time (30 to 60 minutes).

2. Connect the cable to the connector marked with the “ECG" icon on the signal input panel.
3. Place the electrode to the patient according to Section 7.3.2.
4. Attach the ECG lead wires to the electrode

5. Make sure the monitor is turned on and is ready for monitoring.

6. After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system will
display “LEAD OFF” on the screen to alarm the operator.
 It might not display ECG waveform when using ECG cable with 3 lead wires while the setting of “Cable” is set as
“5” in the ECG parameter setup menu. Only single channel of ECG signal can be obtained while using 3 lead wires
and the “Cable” is set as “3”, this ECG signal can be selected between Lead I, Lead II and Lead III.
 In order to obtain other Leads of the ECG signals, such as aVL, aVR, aVF and V, the ECG cable with 5 lead wires
should be used and the “Cable” should be set to “5”. At this situation, 7 Leads of ECG signal (lead I, II, III, aVL, aVR,
aVF, V) can be obtained and displayed simultaneously.

Note:

If any side‐effect such as allergic or itchy reaction is found, remove the electrodes from the patients immediately.

The symbol indicates that the cable and accessories are designed as the “CF” type level for protection against

electric shocks and with defibrillation‐proof capability.


61
Operator’s Manual for Patient Monitor

7.3.2 ECG Electrodes Placement

Electrode Placement

The ECG leads and their corresponding locations are as follows:

Electrode connection 1 Electrode connection 2

(IEC Standard) (AHA Standard)


Electrode position on body surface
Label on lead Label on lead
Color code Color code
wire connection wire connection

Red R White RA Right Arm: The intersection between the


centerline of the right clavicle and Rib 2

Yellow L Black LA Left Arm: The intersection between the


centerline of the left clavicle and Rib 2

Green F Red LL Left Leg: Left part of the upper abdomen

Black N/RF Green RL Right Leg: Right part of the upper


abdomen

White C Brown V Any of the following location (C1‐C6 or


V1‐V6) on chest

White/red C1 Brown V1 4th Intercostal (IC) space at right border


of sternum

White/yellow C2 Brown/yellow V2 4th IC space at left border of sternum

White/green C3 Brown/green V3 Midway between V2 and V4

White/brown C4 Brown/blue V4 5th IC space on left midclavicular line


(blue)

62
Operator’s Manual for Patient Monitor

White/black C5 Brown/red V5 Left anterior axillary line at the


horizontal level of V4

White/purple C6 Brown/purple V6 Left midaxillary line at the horizontal


level of V4

7.4 Understanding the ECG Display


Your display may be configured to look slightly different.

ECG waveform

 "ECG": parameter label.

 "III": ECG lead. III means ECG lead III.

 "25mm/s": ECG waveform sweeping speed, unit is "mm/s".

 "X1": ECG waveform gain. "X1" means the waveform scale with base gain.

 "MONI": ECG filtering mode. There are three types: diagnose, monitoring and operation.

 "S‐T+0.02mV": S‐T segment value, here indicates the value is 0.02mV.

Heart Rate Panel:


Heart rate label and unit
Heart beat symbol
High and low alarm limit
setting for Heart rate

Heart rate value

Arrhythmia symbol

 "HR": heart rate. The 64 on the right is the heart rate measured.

 "bpm": the unit of heart rate, it means "beats per minute".

 " ": the heart‐beat symbol, blinks corresponding to the R wave of ECG waveform.

 "180/40": high and low alarm limit setting for heart rate.

63
Operator’s Manual for Patient Monitor

 " ": Arrhythmia symbol. If the ARR function is set as ON, then this symbol will be displayed.

7.5 Changing ECG Settings


Select "Menu" → “ECG” to enter into ECG related setting.

Note: according to the different function configuration, the ECG parameter setting window may be different, please
refer to the monitor in your hand.

 Speed: the ECG waveform sweeping speed, 4 options: 6.25mm/s, 12.5mm/s, 25mm/s and 50mm/s. The factory
default is 25 mm/s.

 Filter: ECG filtering mode, 3 options: MONI, DIAG, and OPER.

DIAG: extended bandwidth to provide the ECG waveforms with the quality of diagnosis level.
MONI: normal bandwidth to provide noise free ECG waveforms for effective monitoring purpose.
OPER: narrow bandwidth to deeply suppress the interference from electro‐surgical unit during operation.

The default mode is "MONI".

Notes:

1. For different ECG related setting window, and when the ECG filtering mode is set as “OPER”, then items like
“Notch”, “Wires”, “Lead” and “Pacer” are in grey and nonadjustable. The “Notch” shows the lasting setting, the
“Wires” is fixed to be “3 lead wires”, the “Lead” is fixed to be lead “II”, and the “Pacer” is fixed to be unselectable.

2. If the amplitude of an ECG waveform is too large, the peak of the waveform might not be displayed. In this case,
you should change the waveform gain properly.

 Gain: The ECG gain, options: x1/8, x1/4, x 1/2, x 1, x 2, x 4 and Auto. The "Auto" is for automatic gain control. The
default is "x1".

x1/8: 1/8 of the base gain; x1/4: 1/4 of the base gain;

x1/2: 1/2 of the base gain; x1: the base gain;

x2: twice of the base gain; x4: 4 times of the base gain;

Auto: auto gain control; The base gain is 10 mm/mV.

 Notch: only in "DIAG" filtering mode the notch filter can be chosen. 3 options: OFF, 50Hz, 60Hz. The factory
default is 50Hz.

 Wires: The default is "5‐lead", it is necessary to select ECG Lead with “5‐lead” setting to obtain all ECG signals
including Lead I, II, III, aVR, aVL, aVF, and V. The user can also choose "3‐lead" setting. When "3‐lead" is chosen,
only electrodes of R/RA, L/LA, and F/LL are used for detecting ECG signals, and the user can only select ECG signal
of Lead I, or II, or III, the default Lead selection is Lead "II".

Note: if your monitor is configured with 12‐lead ECG function, then you can set “Wires” as “5‐lead” or “12‐lead”
to obtain ECG signals. When “12‐lead” is chosen, then the waveform of lead I, II, III, aVR, aVL, aVF, V1~V6 will be
displayed on the All ECG Trace view.

 Cal 1mV: Generate the 1mV calibration signal internally. This signal is used to self‐test the signal amplitude of the
64
Operator’s Manual for Patient Monitor

monitor. It must be unselected during normal operation. The default is unselected.

 Grid: The display switch of the grid lines on the background of ECG waveform. The default is OFF.

 Pacer: Enable the cardiac pacemaker pulse detection, the default is unselected. When the “Pacer” is selected, the

function of pacemaker pulse detection will be effective. A mark " " will be overlapped on the ECG waveform (as
shown in the following figure.) if the pacemaker pulse is detected while the patient wears a cardiac pacemaker.

Note:

pacemaker pulse inhibition function is always effective for Heart Rate calculation whether you enable or disable
the function of cardiac pacemaker pulse detection or not.

 PARM: to enter into HR alarm setting. See Section “Understanding the Alarm Setting”.

7.6 About Arrhythmia Detection and Template Learning


 ARR: ECG arrhythmia analysis

ARR switch: the switch of ECG arrhythmia detection. The default is ON. This switch does not affect the alarm
function for 5 ARR events (ECG Brady, ECG Tachy, ECG Arrest, VE Run and SVE Run). That’s to say, the detection
and alarm for 5 ARR events is fixed to be ON, and nonadjustable.

Extra ARR Learning: indication of ARR learning status or activating ARR learning manually.

When ARR is set to "ON", the device will start to learn the regular ECG signal automatically for ARR detection and

icon " " will be displayed. The device will finish the learning after a certain period, and the icon will become

" ". The detected arrhythmia waveform will be displayed on the third or the last ECG waveform display
channel; if there is only one ECG waveform display channel, then the detected arrhythmia waveform will be
re‐displayed and frozen on this channel for 8 seconds. The arrhythmia waveform will be re‐displayed on the
cascaded waveform channel if there is a single Lead of ECG signal displayed with cascaded waveform channels.

Note: Because Arrhythmia detection needs a template ECG waveform as reference which is a piece of normal ECG
waveform with regular rhythm and stable amplitude, it is necessary to re‐activate the template learning when the
patient is changed, or the Arrhythmia detection is incorrect. For stronger Arrhythmia detection, it is
recommended to wait for a clean and stable ECG waveform before starting ARR detection during the monitoring.

Note:

When the device is restarted, the Arrhythmia detection is reset to its default status.

65
Operator’s Manual for Patient Monitor

☞ During Arrhythmia detection, incorrect detection might occur if the non‐ECG waveforms (e.g. square
or triangle waveform) appear.
☞ Before starting the 1mV calibration signal, please turn off the Arrhythmia detection.
☞ During Arrhythmia detection, the template learning is very important. The device requires a group of
stable QRS complex waveforms to build up this template. If the system detects Arrhythmia
incorrectly, please re‐activate the template learning and obtain the correct template.

 The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect
atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia.
Therefore, a physician must analyze the arrhythmia information with other clinical findings.

 Take care to initiate template relearning only during periods of normal rhythm and when the ECG signal is
relatively noise‐free. If template learning takes place during ventricular rhythm, the ectopics may be
incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of
V‐Tach and V‐Fib.

7.6.1 Understand the ARR Type

Type Abbreviation Full name

1 ECG TACHY Tachycardia

2 ECG BRADY Bradycardia

3 ECG ARREST Cardiac Arrest

4 MISS BEAT Missing Beat

5 VE EARLY Ventricular Premature Contraction (VPC)

6 SVE EARLY Supra‐ventricular Premature Contraction (SVPC)

7 VE COUPLET Ventricular Couplet

8 SVE COUPLET Supra‐ventricular Couplet

9 VE RUN Ventricular Run

10 SVE RUN Supra‐ventricular Run

11 VE SHORT RUN Ventricular Short Run

12 SVE SHORT RUN Supra‐ventricular Short Run

13 VE BIGEMINY Ventricular Bigeminy

14 SVE BIGEMINY Supra‐ventricular Bigeminy

15 VE TRIGEMINY Ventricular Trigeminy

16 SVE TRIGEMINY Supra‐ventricular Trigeminy

17 VE INSERT Ventricular Insert

66
Operator’s Manual for Patient Monitor

18 SVE INSERT Supra‐ventricular Insert

19 VE RONT Ventricular RonT

20 SVE RONT Supra‐ventricular RonT

7.7 About S‐T Segment Monitoring


Manual S‐T segment measurement operation:

The operator can use the Navigation Knob to do the S‐T segment measurement manually, the value is displayed with
"S‐T +0.xxx mV". There are 2 cross cursors on screen. The red cross is the activated one. The arrows ( and ) on
the red cross indicate the directions that the cross cursor moves when rotating the Navigation Knob. Press the
Navigation Knob can change directions of the cross cursor or change the activating status of the cross cursor.

The measured S‐T value will be accurate only in "Diagnosis" mode, while the S‐T value is less meaningful in other
modes. In "Diagnosis" mode, when ARR event is detected, the S‐T value is only for reference.

 The S‐T segment measuring algorithm has been tested for accuracy of the ST segment data. The significance of
the ST segment changes need to be determined by a clinician.

7.8 Freezing Waveform


When there are waveforms displayed on screen, press the Freeze key to enter into waveform freezing screen. During

freezing, the frozen symbol " " and frozen time will be displayed on the upper right corner of the waveform area.
At the moment, the operator can do S‐T measurement, and get the real‐time value of S‐T segment

There are 2 Freeze types: “ECG waves”, "EEG" (if optioned) and “All waves”, which can be set in System Settings
window.

7.9 Factors Affecting ECG signal


 Interference from Electro‐surgical Unit;

 Doesn’t set the filter mode properly;

 Poor grounding;

 Electrodes are not placed properly;

67
Operator’s Manual for Patient Monitor

 Use expired electrode or use disposable electrode repeatedly;

 The skin placed electrode is unclean or poor contract caused by scurf and hair;

68
Operator’s Manual for Patient Monitor

Chapter 8 Monitoring Respiration (RESP)


8.1 Introduction
Respiration is monitored by measuring the impedance across the thorax via electrodes places on chest. When the
patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the
electrodes. The device applies safe high‐frequency current through ECG electrodes into body and measures the
change of voltage between the electrodes to reflect the thoracic impedance while ECG monitoring is not affected.
Respiration rate (RR) is calculated from these impedance changes, and the respiration waveform is displayed on the
monitor screen.

8.2 Safety Information


 When monitoring the patient’s respiration, it is recommended to use the so‐called “non‐OR” ECG cable which
has no built‐in resistors to prevent the energy loss of defibrillator discharge. Otherwise the performance of
respiration monitoring is degraded.

 The respiration measurement does not recognize the cause of apneas. It only indicates an alarm if no breath is
detected when a preset time has elapsed since the last detected breath. Therefore, it cannot be used for
diagnostic purpose.

 If operating under conditions according to the EMC Standard EN 60601‐1‐2 (Radiated Immunity 3V/m), field
strengths above 1V/m may cause erroneous measurements at various frequencies. Therefore it is
recommended to avoid the use of electrically radiating equipment in close proximity to the respiration
measurement unit.

8.3 Understanding the RESP Display


RESP waveform:

69
Operator’s Manual for Patient Monitor

Respiration Panel:
Label and unit of respiration
Respiratory Sync mark
The high and low alarm
limit setting of RR Respiration rate
Apnea alarm mark

 "RR": the label of Respiration. “rpm” is the unit of the Respiration Rate (respiration per minute). The big font "14"

is the value of Respiration rate.

 " ": Breath symbol. The blinking frequency is the same as the Respiration Rate.

 " ": the high and low alarm limit setting for Respiration Rate.

 : the apnea alarm status in RESP alarm setting, refer to the following Section for details.

8.4 Changing RESP Settings


Select "Menu" → “RESP” to enter into RESP related setting.

 Gain: Respiration amplification/gain times, 4 options: X1/2, X1, X2, X4. The default is X1 for adult and pediatric
patient, and X2 for neonate patient.

X1 waveform scale with base gain X1/2 half scale size of the base gain

X2 twice scale size of the base gain X4 four times scale size of the base gain

 Speed: Respiration waveform sweeping speed of, 2 options: 6.25mm/s and 12.5 mm/s. The default is 12.5 mm/s.

 Apnea: The timeout setting for apnea alarm (in second). It can be set as any number from 5 to 120 seconds, the

step is 1 second. Icon " " displays on the lower left corner of Respiration Panel; When the device has
not detected any breathing signal for the specified time, the “Apnea” alarm prompts on, and alarm sound will be

activated. If it is set as OFF, the icon " " displays on lower left corner of the Respiration Panel.

Note: when “Wires” is set as “12‐lead” in ECG related settings, then “Apnea” can be set as off, 10, 15, 20, 25, 30,
35 and 40.

 Source: Respiration signal source. This item is fixed to be "CO2" if CO2 monitoring function is selected. Otherwise,
the source will be obtained by measuring the thoracic impedance via ECG electrodes, the signal source can come
from the ECG electrodes defined by "ECG Lead I" and "ECG Lead II". (Note: WHEN “12‐lead” is selected, then the
“Source” is fixed to be “ECG Lead II” and nonadjustable.)

 Zero: press it to perform CO2 zeroing.


 PARM: to enter into RR alarm setting. See Section “Understanding the Alarm Setting”.

70
Operator’s Manual for Patient Monitor

 Default: resume to the factory default value.


Note: in RESP settings window, CO2 and/or AG Settings can be entered if your monitor is configured with CO2
monitoring and/or AG Monitoring.

: click it to turn on or off CO2 Monitoring. When the CO2 monitoring is selected, then
all items setting as "RESP" will shift to "CO2". See Chapter Monitoring Carbon Dioxide (CO2).

:click it to turn on or off AG Monitoring. When the AG monitoring is selected, then


all items setting as "RESP" will shift to "AG". See Chapter Monitoring Anesthetic Gas (AG).

71
Operator’s Manual for Patient Monitor

Chapter 9 Monitoring NIBP


9.1 Introduction

9.1.1 The Oscillometric Blood Pressure Measurement

This device applies the typical non‐invasive blood pressure measurement with the oscillometric method. A cuff is
used to occlude the artery by inflating it above the patient’s systolic pressure, the device measures the amplitude of
pressure changes with pulsation in the cuff as the cuff pressure decreases. The pulsations increase in amplitude, and
reach a maximum, then diminish along with the decrement of cuff pressure. The cuff pressure corresponding to the
maximal pulse amplitude approximates to the mean artery pressure (MAP), the cuff pressure at the pulse amplitude
backward reduced according to proper proportion is defined as systolic pressure (SYS), and the cuff pressure at the
pulse amplitude forward reduced according to proper proportion is defined as diastolic pressure (DIA)

9.1.2 The Oscilometric method vs. the Korotkoff Sound Method

Blood pressure measurements by the oscillometric method and Korotkoff sound method have good correlation with
the invasive blood pressure measurement. Notwithstanding, any of the non‐invasive blood pressure measurements
has its one‐sidedness when it is compared to the invasive measurement. Studies show that, the oscillometric method
has its advantages over the Korotkoff sound method in less error, higher reliability and stability especially in critical
cases such as arrhythmia, vasoconstriction, hypertension, shock, etc.

9.2 Safety Information


 When taking the blood pressure measurement on a neonate patient. DO NOT operate in the Adult mode. The
high inflation pressure may cause lesion or even body putrescence. Even though the monitor can identify the
cuff type so it will stop inflation and indicate "Cuff error" when taking the blood pressure measurement for a
neonate in the "Adult" patient type setting. The user (doctor or nurse) should pay more attention to select the
correct patient type.

 It is recommended to take the blood pressure measurement manually

 NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease,
otherwise, partial bleeding will appear.

 DO NOT wrap the cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise, injury may
be caused to the limbs.

 If the patient is moving or suffering tremble, hyperkinesia or arrhythmia, it may cause the inflation time of
inflatable balloon endures longer, which may not only prolong the measurement time, but also result in the
body wrapped by the cuff is troubled by purpura, hypoxemia and neuralgia because of the friction.

 Before the measurement is carried out, select an appropriate measuring mode depending on the patient type
(adult, pediatric or neonate).

 The air‐hose which connects the cuff and monitor should be straightway without any tangle.

 When an adult patient is monitored, the device may fail in giving the blood pressure measurement if the
72
Operator’s Manual for Patient Monitor

pediatric patient type is selected.

 Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate measurement.

 DO NOT twist the air tube or put heavy things on it.

 When unplugging the air tube, hold the head of the connector and pull it out.

 The NIBP measurement will not be affected when the monitor is connected to the patient on whom the
electro‐surgical unit and defibrillator is being used.

 The appearance of arrhythmia results in irregular heart beat which may affect the accuracy of NIBP
measurement. It is recommended to take the measurement again at this situation.

 The blood pressure measurements determined with this device are equivalent to those obtained by a trained
observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American
National Standard, manual, electronic, or automated sphygmomanometers.

 The monitor can be used on the patients who are pregnant or pre‐eclamptic, but close attention should be
paid to such patients.

 The performance of NIBP function can be affected by the extremes of temperature, humidity and altitude,
please use it within the appropriate working environment.

9.3 Measurement Limitations


1. Serious angiospasm, vasoconstriction, or too weak pulse.

2. When extremely low or high heart rate or serious arrhythmia of the patient occurs. Especially auricular
fibrillation will lead to unreliable or impossible measurement.

3. Do not take the measurement when the patient is connected with an artificial heart‐lung machine.

4. Do not take the measurement when the patient uses diuresis or vasodilator.

5. When the patient is suffering from major hemorrhage, hypovolemic shock and other conditions with rapid
blood pressure change or when the patient has too low body temperature, the reading will not be reliable, for
reduced peripheral blood flow will lead to reduced arterial pulsation.

6. Patient with hyperadiposis;

9.4 Measurement Mode


There are three measuring mode for NIBP measurement:

 Manual: measurement on demand.

 Auto: continually repeated measurements at set intervals.

 STAT: continually rapid series of measurements over a five minute period, then return to the previous mode.

73
Operator’s Manual for Patient Monitor

9.5 Setting Up the NIBP Measurement

9.5.1 Preparing to Measure NIBP

1. Power on the monitor.

2. Check the patient information area on the screen. Set a correct patient type, select a correct cuff size.

3. Connect the tube with cuff to the connector marked with “NIBP” icon on the signal input panel.

4. Select a cuff with correct size, then unfold the cuff and wrap it around the patient’s upper arm as follows:

 Determine the patient’s limb circumference.

 Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff
should be 40% of the limb circumference, or 2/3 of the upper arm’s length. The inflatable part of the cuff
should be long enough to encircle at least 50% to 80% of the limb. When putting on the cuff, unfold and
wrap it around the upper arm evenly to appropriate tightness.

 Remember to empty the residual air in the cuff before the measurement is commenced.

 Locate the cuff in such a way that the artery mark “ ” is at a location where the clearest pulsation of
brachial artery is observed.

 The cuff should be tightened to a degree where insertion of one finger is allowed.

 The lower end of the cuff should be 2cm above the elbow joint.

9.5.2 Starting and Stopping Measurements

Starting and Stopping NIBP Measurements by pressing NIBP measure key " ".

 Too frequent blood pressure measurements may cause purpura, ischemia and neuropathy in the limb with the
cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb
for normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to another site or stop the
blood pressure measurements immediately.

74
Operator’s Manual for Patient Monitor

9.5.3 Factors Affecting NIBP Measurement

Like common non‐invasive blood pressure measurement, improper operation may cause inaccurate or blank result or
misunderstanding of the measuring information when the oscillometric method is used to take the blood pressure
measurement. These points need particular attention of the operators.

1. Requirements of the cuff:

1) Appropriate cuff should be selected according to the age of the patient.

2) Remember to empty the residual air in the cuff before the measurement is commenced.

3) Locate the cuff in such a way that the artery mark “ ” is at a location where the clearest pulsation of
brachial artery is observed.

4) The cuff should be tightened to a degree where insertion of one finger is allowed.

5) The lower end of the cuff should be 2cm above the elbow joint.

2. The patient should lie on the back so that the cuff and the heart are in a horizontal position and the most accurate
measurement is taken. Other postures may lead to inaccurate measurement.

3. Do not speak or move before or during the measurement. Care should be taken so that the cuff will not be hit or
touched by other objects. The air tube which connects the cuff and monitor should be straightway without any
tangle.

4. The measurement should be taken at appropriate intervals. Continuous measurement at too short intervals may
lead to pressed arm, reduced blood flow and lower blood pressure, and resulting inaccurate measurement of blood
pressure. It is recommended the measurement be taken at intervals of more than two minutes.

5. With the oscillometric method, when blood pressure is measured, the inflation pressure of the cuff will be
automatically adjusted according to the previous measurement. Generally, the initial inflation pressure is 150mmHg
(for the adult mode) or 120mmHg (for pediatric) or 70 mmHg (for neonate) when it is powered on. Following that,
28mmHg (for adult) or 25mmHg (for pediatric) or 25mmHg (for the neonate) will be added on the basis of the last
measurement of systolic pressure. In this way, when the blood pressure rises or the patient is changed, the device
may fail in giving the result after the first‐time inflation. This device will automatically adjust the inflation pressure
until the measurement is taken, after that, up to four times retry will be allowed.

6. When an adult patient is monitored, the device may fail in giving the blood pressure measurement if the Pediatric
or neonate patient type is selected.

7. When taking NIBP measurement on pediatric or neonatal patients, the operator must select correct patient type
depending on different patients (refer to NIBP menu setup) and do NOT operate with the adult patient type setting.
The high inflation pressure for adult is not suitable for pediatric patients.

75
Operator’s Manual for Patient Monitor

9.6 Understanding the NIBP Numerics


NIBP Panel:

NIBP label and unit NIBP measurement mode

Diastolic pressure value


Systolic pressure value
Mean arterial pressure

Pulse rate value

 "NIBP":the label of blood pressure. "123" is the systolic pressure value, "80" is the diastolic pressure value, and
"95" is the mean arterial pressure.

 "mmHg": the unit of blood pressure value, 1kPa = 7.5mmHg.

 "PR 62": pulse rate value when taking blood pressure measurement.

 "Manu": the icon of NIBP measurement mode. There are 3 modes: "Manual", "Auto" and "STAT". When in
"AUTO" mode, a count‐down timer is displayed as well.

9.7 Changing NIBP Settings


Select "Menu" → “NIBP” to enter into NIBP related setting.

 Mode: "MANU", "AUTO", "STAT" and "Customized Multi‐cycle" can be selected. The default is "MANU".

 In "MANU" mode, press the NIBP measure key " " manually can start or stop NIBP measurement.

 In "AUTO" mode, the device repeats NIBP measurement automatically with the set time interval. In this
mode, the manual interference still works.

 In "STAT" mode (only used for adult), press the NIBP measure key " ", the device will do NIBP
measurement again and again. The device will not stop making measurement until the measuring time is
over 5 minutes or the operator stops it manually.

 Customized Multi‐cycle: move the cursor on "Customized Multi‐cycle" and click "OK" to enable this function. The
user can customize the related parameters: Phase, time cycle (the time interval between two measurements) and
repeats. There are 5 phases: A, B, C, D and E. The user can set the time cycle and repeats for Phase A to Phase E.

 Time cycle: 1min, 2min, 3min, 4min, 5min, 10min, 15min, 20min, 25min, 30min, 35min, 40min, 45min, 50min,
55min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h and 4h for optional.

 Repeats: OFF, 1, 2, ...9 and 10 for optional.

For example, firstly, the monitor enter into Phase A (making NIBP measurement once every 5 minutes, and repeat
once only); Secondly, entering into Phase B (making NIBP measurement once every 10 minutes, and repeat once

76
Operator’s Manual for Patient Monitor

only); Thirdly, entering into Phase C (making NIBP measurement once every 20 minutes, and repeat 2 times);
Fourthly, entering into Phase D (making NIBP measurement once every 30 minutes, and repeat 5 times); Lastly,
entering into Phase E (making NIBP measurement once every 60 minutes, and repeat once only). In the period of
30 minutes, if the NIBP measurement is less than 6 times and NIBP measurement mode is not changed, then the
monitor will start to make NIBP measurement from Phase A to E automatically.

Caution: STAT mode can only be used for adult.

Notes:

When changing patient, the default NIBP measuring mode is “Manual”.

For “Adult”, if the NIBP measuring mode is set as “STAT”, then the monitor will not save this setting when you
shutdown the monitor. That’s to say, when re‐starting the monitor, the NIBP measuring mode for Adult is “Manual”.

For all patient types, if the NIBP measuring mode is set as “Manual”, or “Auto”, or “Customized Multi‐cycle”, then the
monitor will save this setting when you shutdown the monitor.

 Cycle: it can be set only in "AUTO" mode. Cycle means the time interval between measurements when the
measuring mode is set to Auto. The Cycle options are: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min,
10min, 15min, 20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h,
5h, 5.5h, 6h, 6.5h, 7h, 7.5h and 8h. that’s, the range is from 1 minute to 10 minutes, step is 1 minute; for range
from 10minutes~1hour, step is 5 minutes; for range from 1 hour~8 hour, step is 0.5hour. When in AUTO mode

and this item is set, the operator must manually press NIBP measure key " " for the first time, then the
device will start time counting down. The device will start taking the next blood pressure measurement
automatically after finishing counting down.

 Unit: the pressure unit. "mmHg" and "kPa" can be selected. 1 kPa =7.5 mmHg.

 Init. Pressure: Cuff pressure to be inflated initially. Its range is different depending on patient type.

for adult: 80, 100, 120, 140, 150, 160, 180, 200 mmHg;

for pediatric : 80, 100, 120, 140, 160, 180, 200 mmHg;

for neonate: 60, 70, 80 mmHg.

Note: if your monitor is configured with SunTech NIBP module, then the initial cuff pressure range for adult is
120~220mmHg.

 PARM: to enter into NIBP (SYS, DIA, MAP,) alarm setting. See Section “Understanding the Alarm Setting”.

 Verification: to verify the NIBP pneumatic system, is used to verify the pressure accuracy and check the air
leakage of the pneumatic system, which should be conducted by technicians in the specified environment. It
includes “Verification A”, “Verification B” and “Leakage Check”.

 Verification A & Verification B: the 2 kinds of verification of the pressure accuracy. Press the relevant button to
start Verification A or B. When completed, it is necessary to stop the verification manually by pressing “Stop”
button. System will also stop the verification when “Exit” button pressed.

 Leakage Check: it is used by technicians to perform a leakage inspection for NIBP pneumatic system..

Important:

77
Operator’s Manual for Patient Monitor

Verification A: the monitor will auto inflate to the preset pressure value (depending on the patient type) by pump,
then it close the deflating valve. Comparing the pressure value on device with that on standard pressure manometer,
and verify that whether the pressure accuracy exceeds the rated tolerance range.

The auto inflating pressure value for Adult: >190mmHg (25.3kPa)

The auto inflating pressure value for Pediatric: >160mmHg (21.3kPa)

The auto inflating pressure value for Neonate: >80mmHg (10.7kPa)

Verification B: the monitor will close the valve, the pressure should be inflated manually. Comparing the pressure
value on device with that on standard pressure manometer, and verify that whether the pressure accuracy exceeds the
rated tolerance range.

Note: if the verification window pops up during verification, you can press "Close" button to exit form it only, but it is
forbidden to exit from by pressing "Display View Key".

78
Operator’s Manual for Patient Monitor

Chapter 10 Monitoring Oxygen Saturation (SpO2)


10.1 Introduction
The functional oxygen saturation (SpO2) ‐ a percentage of the hemoglobin that can transport oxygen, is monitored by
this device via a non‐invasive optical technique. Based on the principle that oxygenated hemoglobin (HbO2) and
deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light,
the device measures the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected
wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals
by the photo‐detector in the probe. The SpO2 module processes the electrical signals and gives out waveform data and
digital values for SpO2 and pulse rate displayed on the screen.

10.2 Safety Information


 Continuous use of fingertip SpO2 sensor may result in discomfort or pain, especially for those patients with
microcirculatory problem. It is recommended that the sensor should NOT be applied to the same site for over
two hours, please inspect the monitoring site every 1~2 hours for skin integrity, and change the measuring site
periodically if necessary.

 Check SpO2 probe application site periodically (every 30 minutes) to determine circulation, positioning and skin
sensitivity.

 SpO2 measuring site must be examined more carefully for some special patient. Do NOT place the SpO2 sensor
on the finger with edema or fragile tissue.

 Avoid placing the SpO2 sensor on the same extremity with an arterial catheter, blood pressure cuff, or
intravascular infusion line, otherwise the blood flow could be interrupted by the cuff or the circulatory
condition could make low blood perfusion so that would result in no pulse found or loss of pulse during SpO2
monitoring and further cause false alarm.

 The SpO2 measurement of this monitor may not work effectively for all kinds of patients, for whose with weak
pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the
measurement will be more sensitive to interference, if stable readings cannot be obtained at any time,
discontinue use of SpO2 monitoring function.

 For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid
indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and
some with icterus problem, the SpO2 determination by this monitor may be inaccurate.

 The drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed
for serious error of SpO2 measurements.

 Excessive ambient light may affect the measuring result, it includes fluorescent lamp, dual ruby light, infrared
heater, and direct sunlight etc.

 As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia, the
measurement result of some patients with serious anemia may also present as good SpO2 value.

 Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate

79
Operator’s Manual for Patient Monitor

oxygen saturation measurements.

 Vigorous movement of the patient, strong ambient light, or extreme electro‐surgical interference may also
affect the SpO2 measuring accuracy.

 DO NOT stare at the light of SpO2 sensor (infrared is invisible) when switch it on, for the infrared may do harm
to the eye.

 The information, such as the range of the peak wavelengths and maximum optical output power of the light by
the SpO2 sensor can be especially useful to clinicians.

 Always observe the plethysmogram (waveform), which is auto‐scaled (normalized). When the measured signal
is inadequate, the waveform will be not smooth or irregular, the SpO2 reading may be unlikely true or
displayed with “‐‐”, and even a technical alarm will be generated. If in doubt, rely on your clinical judgement,
rather than the monitor readout.

 Please do not use the SpO2 sensor and the monitor when doing the MRI imaging, or burn may be caused by
faradism.

 For disposal SpO2 sensor, if the sterile packaging is damaged, do not use it any more.

 Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor.

 Before each use, surface‐clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl Ethanol. If low‐level disinfection is required, use a 1:10 bleach solution.

 When the temperature of SpO2 sensor is abnormal, do not use it any more.

 Please do not allow the cable to be twisted or bent.

 Please do not use nail polisher or other cosmetic product on the nail.

 The fingernail should be of normal length.

 The SpO2 sensor cannot be immersed into water, liquor or cleanser completely, because the sensor has no
capability to resist the harmful ingress liquid.

 Do not disinfect any SpO2 sensor by irradiation, steaming, or ethylene oxide.

 Carefully route cables to reduce the possibility of patient entanglement or strangulation.

☞ The clinical study for SpO2 measurement accuracy was done on human subjects according to Standard ISO
80601‐2‐61.

☞ A functional tester or SpO2 simulator cannot be used to assess the accuracy of the oximeter or a SpO2 sensor.
However, it can be used to check how accurately a particular oximeter is reproducing the given calibration
curve. Before testing the oximeter by a functional tester, please firstly ask the manufacturer which calibration
curve is used, if necessary, request the manufacturer for its dedicated calibration curve and download it into
the tester.

10.3 Apply the Sensor


1. Select an appropriate sensor and probe according to the module type and patient category..

2. Apply the sensor to the proper site of the patient.


80
Operator’s Manual for Patient Monitor

3. Select an appropriate adapter cable according to the connector type and plug this cable into the SpO2 connector.

4. Connect the sensor cable to the adapter cable.

10.4 Using Probe and Sensor


When selecting a SpO2 probe or sensor, do consider the patient’s category, adequacy of perfusion, availability of probe
site and anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor.

We provide several probes for optional, please refer to the following description according to the probe/sensor
you’ve purchased.

Type 1: Adult SpO2 Finger Clip Sensor

Insert one finger (index finger is preferred, but middle or ring finger with proper nail length is possible as well) into the
probe according to the finger mark on the probe, shown as below.

Type 2: Pediatric SpO2 Finger Clip Sensor

(A) With the upper and lower jaws open, place a finger evenly on the base of the clip. Push the fingertip against the
stop so that it is over the sensor window.

(B) Spread open the rear tabs of the sensor to provide even force over the length of the pads.

(C) The sensor should be oriented in such a way that the cable is positioned along the top of the hand.

Type 3: Adult/Pediatric SpO2 Finger Rubber Sensor

(A) Hold the sensor with its opening towards the patient’s finger, the sensor should be oriented in such a way that
the sensor side with a fingertip sign is positioned on the top.

81
Operator’s Manual for Patient Monitor

(B) Insert the patient’s finger into the sensor until the fingernail tip rests against end of the sensor. Adjust the finger to
be placed evenly on the middle base of the sensor. Direct the cable along the top of the patient’s hand. Apply
adhesive tape to secure the cable if necessary.

Type 4: Y‐type Adjustable Neonate SpO2 Sensor


Sensor adapter: wrapper
Y type sensor

Type 5: Y type Neonate SpO2 sensor

Receiver (square)
Light source (round) Foot wrap

Ankle wrap
Y type sensor

 For correct placement on foot, place the sensors on the outside of the foot behind the pinky toe. Make sure the
sensor touches the skin closely, then secure the foot wrap with Velcro. Do not over‐tighten.

Pinky toe Foot wrap Foot wrap Pinky toe

Ankle wrap Ankle wrap


Left foot (wrap goes under the foot) Right foot(wrap goes from top of the foot)
 Use the ankle wrap to secure the sensor cable on the ankle or leg. Do not over‐tighten.

Foot wrap

Ankle wrap

82
Operator’s Manual for Patient Monitor

10.5 Understanding the SpO2 and PR Display


Plethysmogram:

 "Pleth": label for abbreviation of plethysmogram.

SpO2 Panel:

Label and value of perfusion index

SpO2 label Label of pulse rate

Pulse intensity bar graph Pulse rate value

High and low alarm limit SpO2 value


for SpO2

 "SpO2": SpO2 label. “99” is the current SpO2 value.

 "PR": the label of Pulse Rate. “65” is the current Pulse Rate value.

 "PI%": the label of Perfusion Index, "0.59" is the Perfusion Index.

 "PR": Label of pulse rate.

 " ": the high and low alarm limit setting for SpO2.

 " ": pulse intensity bar graph.

10.6 Changing SpO2 and PR Settings


Select "Menu" → “SpO2” to enter into SpO2 related setting.

 SE Threshold (%): set the threshold of oxygen desaturation event (%), the value range is from 1 to 12, step is 1.

The default is 3(%).

 Beep Volume: to set the pulse beep sound volume. Its setting range is "0 ~ 10" level. The default is 5. If you set

the beep volume as "0", it means the pulse beep sound is off. It's not recommended to set it as “0”.

 PARM: to enter into SpO2 alarm setting. See Section “Understanding the Alarm Setting”.

The conditions to trigger SpO2 Event (SE):

83
Operator’s Manual for Patient Monitor

Condition 1:

If the value difference between current SpO2 value and the average value in the latest 1 minute is larger than the

set threshold, and it keeps true for at least 8 seconds, then a SE is generated.

Condition 2:

When the current SpO2 value is between 90% and 100%, and the value difference between current SpO2 value and

the average value in previous second is larger than the set threshold, then a SE is generated too.

10.7 Nellcor SpO2 Module (Optional)


 If your monitor is configured with Nellcor SpO2 Module, then the SpO2 related setting window is as shown in
below figure.

 SE Threshold(%): set the threshold of oxygen desaturation event (%), the value range is from 1 to 12, step is 1.
The default is 3(%).
 SatSeconds: SatSeconds sensitivity setting, to set the max buffering time of activating SpO2 alarm. Options are
“0”, “10”, “20”, “50” and “100”. If you set SatSeconds as “0”, it means to turn off the SatSeconds alarm
management function.
The over‐limit points multiplied over‐limit seconds makes SatSeconds.
SpO2 panel for Nellcor SpO2 module:

“Interference” icon

SatSeconds icon and


sensitivity setting

Notes:
1. When inserting finger into the probe cushion, then searching pulse icon “ ” appears on the upper side of the SpO2
panel. However, once the SpO2 /PR readings appear, or probe/ finger is off, then icon “ ” will disappear.

2. When interference (caused by e.g. shaking finger) appears, then icon “ ” appears on the upper middle side of

the SpO2 panel. However, once the interference disappears, or probe / finger is off, then icon “ ” will disappear.

84
Operator’s Manual for Patient Monitor

Below is the related alarm information for Nellcor SpO2 module.

No. Event Alarm level Remark

1 SpO2 INOP Such alarm will not display on alarm information

2 SpO2 firmware error area, but it will be recorded as alarm event which

3 Communication error can be reviewed on “Alarm event”. these events

4 SpO2 faulty sensor High priority alarm are mostly unrecoverable faults.

5 SpO2 hardware error

6 SpO2 module error

7 SpO2 sensor error It means the SpO2 sensor identifications fails.

8 SpO2 sensor disconnected The sensor cable or extension cable is not

Medium priority connected to the monitor.

9 SpO2 probe off alarm It means the sensor cable is connected, but the

probe is out of the measuring site.

85
Operator’s Manual for Patient Monitor

Chapter 11 Monitoring Temperature


11.1 Introduction
The body temperature is monitored by direct measuring mode with the temperature sensor of thermistor type. Very
small amount of constant current is applied to the temperature sensor to avoid self‐heating, the voltage across the
thermistor is measured, and further converted to the temperature reading according to the temperature‐resistance
characteristic for a specific type of thermistor. The temperature measuring circuit does the self‐testing periodically to
prevent false reading when there is failure in hardware.

You can simultaneously monitor two temperature sites using the device, for specific model, only one channel
temperature is available.

11.2 Safety Information


 Verify that the probe detecting function works correctly before monitoring. Unplug the temperature probe
cable from the T1 or T2 connector, and the monitor can display the message [T1 Sensor Off] or [T2 Sensor Off]
and give alarm tones correctly.

 Make correct choice in setup menu for “KRK” and “YSI” series of temperature sensor used, since they have
different temperature‐resistance characteristic (KRK thermistor has 10.000K ohms @25oC, YSI thermistor has
2.252K ohms @25oC). Mismatching will cause wrong temperature reading or even out of range.

11.3 Making a TEMP Measurement


Please follow the corresponding methods to make temperature measurement according to the temperature
transducer you selected.
 Connecting the thermal temperature sensor:

The temperature sensor is thermo‐resistor type it needs time to respond the temperature change, so the accurate
temperature value displays after a while. The temperature sensor equipped may have different shape for measuring
body surface temperature or cavity temperature respectively.

Normal value for body surface: 36.5°C ~37°C;

Notes:

 For body surface temperature probe, attach the TEMP sensor to the patient, generally if the TEMP sensor and
skin doesn’t contact closely, the measured value becomes lower, so for those who have requirement for
temperature monitoring, add a proper pad to the sensor and fix it with adhesive tape to make them contact
firmly.

 Especially for pediatric patient, they have more activities, pay more attention to the sensor fixing.

 The TEMP sensor is designed for use with the specific patient monitor, which cannot be used as applied part to
other products.

 The operator is responsible for checking the compatibility of the patient monitor and sensor type including
cable before use.

 Incompatible components can result in degraded performance.


86
Operator’s Manual for Patient Monitor

 Operation Procedures for thermal temperature transducer:

1. Securely attach the transducer to the patient;


2. Connect the cable to TEMP probe connector marked "TEMP" in the panel.

3. Check that the menu setting is matching the used temperature sensor type.

4. Check that the alarm settings are appropriate for this patient.

Note: When unplugging the probe, be sure to hold the head of the connector and pull it out.

11.4 Understanding the TEMP Display


3

5
1

1. TEMP1 ℃: Temperature 1 mark and unit. Temperature unit: ℃ or ℉。

2. 36.5: displays the temperature measured at temperature channel 1.

3. TEMP 2: Temperature channel 2.

4. 37.0: displays the temperature measured at temperature channel 2.

5. TD 0.5: Temperature difference, namely the difference between temperature 1 and temperature 2.

11.5 Changing TEMP Settings


Select "Menu" → “TEMP” to enter into TEMP related setting.

 Temp Unit:Temperature unit. The default is ℃ (Celsius) and can be set as ℉ (Fahrenheit), the default is "℃".

 Probe type: KRK and YSI can be selected. KRK and YSI are two different type. If the used type and the set type is
different, then the measured value is invalid.

 TD: the absolute temperature difference. When the temperature difference is higher than preset value, then the
device will activate alarm. If there is only one temperature , the TD shows "――".

 PARM: to enter into RESP alarm setting. See Section “Understanding the Alarm Setting”.

87
Operator’s Manual for Patient Monitor

Chapter 12 Monitoring IBP


12.1 Introduction

Invasive Blood Pressure (IBP) is a direct measurement of the patient’s arterial or venous blood pressure. A catheter is

used and inserted directly into a vein, artery or other pressure access areas, and is connected to a pressure transducer

for measuring systolic, diastolic and mean blood pressures. The device can choose to monitor 2 or 4 (for specific model)

channels IBP depending on the configuration. The device can display the systolic, diastolic and mean blood pressures

and a waveform for each pressure channel.

12.2 Safety Information


 The pressure tube which connects the catheter and the pressure transducer should be straightway without any
tangle.

 Use the pressure transducer kit specified in this manual. Never reuse disposable pressure transducers.

 Make sure that the applied parts never contact other conductive parts.

 To reduce the hazard of burns during high‐frequency surgical procedures, ensure that the monitor’s cables and
transducers never come into contact with the high‐frequency surgical units.

 When using accessories, their operating temperature should be taken into consideration. For details, refer to
instructions for use of accessories.

 Use the accessories specified by the manufacturer, when a defibrillator is used.

 Improper use of a defibrillator may cause injury to the patient. The user should determine whether to perform
defibrillation or not according to the patient’s condition.

 Before defibrillation, the user must ensure both defibrillator and monitor have passed the system test and can
be safely used jointly.

 Do Not use the damaged pressure tube and transducer.

 If air bubble appears in pressure tube, please fill the tube with saline solution again. Air bubble may cause
inaccurate reading.

 When doing ICP measurement to the patient who is sitting, please keep the pressure transducer and the top of
patient’s ear at the same level, or it may lead to error reading.

 When unplugging the cable from the monitor, be sure to hold the head of the connector and pull it out.

 Each time when connecting transducer kit or using a new transducer kit, zero calibration to the IBP transducer
must be carried out.

 Before using the tube, cable and/or transducer, make sure that all accessories meet the performance
requirements which is not changed by aging or environmental conditions.

88
Operator’s Manual for Patient Monitor

12.3 Setting Up the IBP Measurement


If your monitor is configured with Plugin IBP Module, then you need to make sure that the IBP Plug‐and‐Play box is
securely inserted. If the box is inserted successfully, then the IBP icon appears on the upper right side of the screen.
Refer to the following description.

If your monitor is configured with internal IBP Module, then the IBP icon appears on the upper right side of the
screen.

12.3.1 Understanding IBP Icon and IBP Plugin Box (Optional)

The Plugin box (optional) can be configured with 2 IBP module and one C.O. module, or be configured with 2 IBP
modules, as shown in below figure, or be configured with C.O. module, refer to the monitor in your hand.

For some models of the device, the icon for the IBP plugin box will be displayed on the upper right corner of the

monitor, for example, " " for IBP and C.O. Plugin box, " " for IBP Plugin box, " " for C.O. Plugin box.

Appearance for IBP and C.O. Plugin box

The icons "IBP1" and "IBP2" are the connectors to the IBP1 and IBP2. If the Plugin box is inserted into the left slot,
then "IBPL1" and "IBPL2" will be displayed on the screen of the monitor. The connector will be different because of
the different configuration, please refer to the monitor in your hand.

"IBP1" and "IBP2" marked on the device is the icons for IBP cuff connector of the internal IBP module. The internal IBP
module will be shown as "IBP1" and "IBP2" in software and operation.

12.3.2 IBP Transducer Kit Connection

1. On the signal input panel of the patient monitor, there are 2 (or 4) connectors with label “IBP1” and “IBP2” (or label
“IBP1”, “IBP2” , “IBP3”, and “IBP4”) depending on your monitor configuration, which are used to connect the IBP
transducer kit. If you want to use IBP monitoring function, please connect the IBP transducer kits into the IBP
connectors on the panel of the patient monitor. Please make sure the cables of the transducer kits are not folded or

89
Operator’s Manual for Patient Monitor

twisted.

2. Prepare the pressure tube and transducer by filling the pressure tube with saline solution, and make sure that the
pressure tube is free from any air bubble.

3. Connect the pressure catheter coming from the patient to the pressure tube of the transducer kit, and ensure there
is no air present in the pressure tube, pressure transducer or pressure catheter.

4. The pressure transducer must be placed at the same level with the patient’s heart.

5. Check if the correct label name is chosen, see below table.

6. Zero the transducer.

Label Description Label Description

ART Artery pressure LAP Left atrium pressure

CVP Central vain pressure RAP Right atrium pressure

ICP Intracranial pressure PA Pulmonary pressure

AUXP1 Auxiliary pressure 1 AUXP2 Auxiliary pressure 2

Label and description

IBP transducer kit with disposable pressure sensor

12.4 Understanding the IBP Display


IBP Waveform:

 IBPL1: Parameter label, it means that the left inserted plugin module is the IBP1.
 [0 300]: IBP coordinates scale.
Note: for some monitors, it may only show 2 channels of waveform.

90
Operator’s Manual for Patient Monitor

IBP Panel:

IBP mark and unit


Measuring position
Systolic pressure
Mean arterial pressure
Diastolic pressure

IBP Alarm information


 The IBP alarm information will be displayed on the alarm information area.
 Technical alarm: "Probe off" and so on.
 Physiological alarm: "IBPL1 Low SYS " and so on.

12.5 Changing IBP Settings


Select "Menu" → “IBP” to enter into IBP related setting.

 Label: the name of blood pressure to be measured. It has the following options:

ART‐‐‐artery pressure PA‐‐‐pulmonary pressure


CVP‐‐‐central vain pressure RAP‐‐‐right atrium pressure
LAP‐‐‐left atrium pressure ICP‐‐‐intracranial pressure
AUXP1‐‐‐auxiliary pressure 1 AUXP2‐‐‐auxiliary pressure 2

 AUXP ‐‐ auxiliary pressure: AUXP1/2 can be chosen if the actual measuring pressure is not in the list of ART, PA,
CVP, RAP, LAP, and ICP. The operator can choose the Calculating Mode according to the type of blood pressure. If
artery pressure is monitored, please choose "dynamic", then the reading out will include Systolic, Diastolic and
MAP. If vein pressure is monitored, please choose "static", then only the MAP will be displayed.
 Calc. Mode: when the Label is AUXP1 or AUXP2, the calculate mode can be “static” or ”dynamic”.
 Filter: there are two options for the pressure waveform filtering ‐‐‐12.5Hz and 40Hz, the factory is 12.5Hz.
 Avg. time: the time period for averaging to calculate Mean Pressure. Setting range from 1s to 12s, the factory is
8s.
 Unit: pressure unit. 2 options: mmHg and kPa.
 Zero: perform zero calibration for pressure transducer. Press "Zero" button, then zero calibration dialog pops up
on the screen, then press "Zero" to start calibration. (Note: before performing zero calibration, please make sure
that the transducer is well connected, or the zero calibration will not work.)
 PARM: to enter into IBP alarm setting. See Section “Understanding the Alarm Setting”.

91
Operator’s Manual for Patient Monitor

Chapter 13 Monitoring Carbon Dioxide (CO2)


13.1 Introduction
CO2 Measuring Principle

The principle is based on the fact that CO2 molecules absorb infrared light energy of specific wavelengths, with the
amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through
a gas sample containing CO2, the electronic signal from a photodetector (which measures the remaining light energy),
can be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately reflect CO2
concentration in the sample. To calibrated, the photodetector’s response to a known concentration of CO2 is stored in
the monitor’s memory.

The monitor determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by
these gases. EtCO2 is displayed as a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals
(kPa). In addition, a CO2 waveform (capnogram) may be displayed which is a valuable clinical tool that can be used to
assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring
the time interval between detected breaths.

Mainstream vs. Sidestream Sampling

Mainstream CO2 sensors are placed at the airway of an intubated patient, allowing the inspired and expired gas to
pass directly across the IR light path. The major advantages of mainstream sensors are fast response time and
elimination of water traps.

Sidestream CO2 sensors are located away from the airway, requiring a gas sample to be continuously aspirated from
the breathing circuit and transported to the sensor by means of a pump. This type of system is needed for
non‐intubated patients.

When using mainstream CO2 sensors, check the window for the patient secretions pooled on periodically. Because
that condition may affect the accuracy of the measurement or even make the sensor not work.

When using sidestream CO2 sensors, there is a water trap or a part of the sampling tube with dehumidifying function.
Please periodically check the flow sensor and tubing for excessive moisture or secretion buildup.

13.2 Safety Information


 CO2 Sensor is a precision measuring part, please use it correctly and store it properly;

 Precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other
equipment.

 Failure of Operation: If the CO2 Sensor fails to respond as described in this user manual; DO NOT use it until
approved for use by qualified personnel.

 DO NOT position the sensor cables or tubing in any manner that may cause entanglement or strangulation.

 Support the airway adapter to prevent stress on the ET tube.

 Reuse, disassembly, cleaning, disinfecting the single patient use CO2 cannula kits and on‐airway adapters may
compromise functionality and system performance leading to a user or patient hazard. Performance is not

92
Operator’s Manual for Patient Monitor

guaranteed if an item labeled as single patient use is reused.

 Inspect the sidestream on‐airway adapters and sidestream sampling kits for damage prior to use. DO NOT use
the sidestream on‐airway adapters and sidestream sampling kits if they appear to be damaged or broken.

 If the CO2 waveform (Capnogram) appears abnormal, inspect the CO2 airway adapters and replace if needed.

 Periodically check the CO2/Flow sensor and tubing for excessive moisture or secretion buildup. Do not use
them if there is excessive moisture or exterior condensation.

 Electric Shock Hazard: The CO2 Sensor contains no user serviceable parts.

 Refer service to qualified service personnel. Do not open the sensor cabinet at will, as electric shock hazard
may occur.

 Place the exhaust vent of the CO2 Sensor in drafty ambient and do not let anything block the exhaust vent.

 Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have been damaged. Refer
servicing to qualified service personnel.

 DO NOT sterilize or immerse the CO2 Sensor in liquids.

 Replace the sidestream on‐airway adapters and sidestream sampling kits if excessive secretions are observed.

 Do not operate the CO2 Sensor when it is wet or has exterior condensation.

 Monitor the CO2 waveform (Capnogram). If you see changes or abnormal appearance, check the patient and
the sampling line. Replace line if needed.

 DO NOT use device on patients that cannot tolerate the withdrawal of 50 ml/min +/‐ 10 ml/min from the
airway or patients that cannot tolerate the added dead space to the airway.

 Do not apply excessive tension to any sensor cable or pneumatic tubing.

 Explosion Hazard: DO NOT use in the presence of flammable anesthetics or other flammable gasses. Use of the
CO2 Sensor in such environment may present an explosion hazard.

 Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have
been damaged. Refer servicing to qualified service personnel.

 The power voltage over monitor working voltage may cause damage to CO2 sensor. Likewise, too low power
voltage may affect the CO2 measuring accuracy or even make the CO2 sensor not work.

 When changing sampling tube, it is suggested to choose the default sampling tube with dehumidifying
function. The sampling tube without dehumidifying function may be easily blocked by excessive moisture. (Use
life: ordinary sampling tube: 6~12 hours; the sampling tube with dehumidifying function: about 120 hours.)

 If the measurement shows an abnormity caused by sampling tube block, please replace it.

 The total length of the sampling tube and extending airway tube shouldn’t be longer than 3 meters, too long
may cause measurement abnormity. If using T connector sampling cannula kits, please insert the sampling
tube with the tubes upward to avoid the effect of excessive moisture.

 Altitudes are different in different area, so set the Barometric Pressure setting value as the ambient barometric
pressure.

93
Operator’s Manual for Patient Monitor

 Use the manufacturer approved accessories only.

 While using the CO2 sensor, a system leak, that may be caused by an uncuffed endotracheal tube or a damaged
CO2 sensor may significantly affect flow‐related readings. These include flow, volume, pressure and other
respiratory parameters.

 When stopping CO2 monitor, please disconnect the CO2 sensor from the patient monitor.

☞ Disposal of the CO2 Sensor and its accessories should comply with national and/or local requirements.

☞ In the presence of electromagnetic devices (i.e., electrocautery), patient monitoring may be interrupted due to
electromagnetic interference. Electromagnetic fields up to 20 V/m will not adversely affect system
performance.

☞ Nitrous oxide, elevated levels of oxygen, helium and halogenated hydrocarbons can influence the CO2
measurement.

☞ Excessive moisture in the CO2 may affect the accuracy of the flow measurement.

13.3 CO2 Sensor Connection

13.3.1 Sidestream CO2 Sensor Connection

Demonstration for Sidestream CO2 Sensor Connection

1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labeled “CO2” on the connector panel
of the monitor;

2. The sample cell of the sampling cannula must be inserted into the sample cell receptacle of the CO2 Sensor. A “click”
will be heard when the sample cell is properly inserted, then connect to the airway tube. After finishing sensor
connection, and make sure that the air input end is exposed to room air and away from all sources of CO2,
including the ventilator, the patient’s breath and your own. Next, turn on the CO2 switch at CO2 Setup Screen and
then wait 2 minutes for the sensor warm‐up.

94
Operator’s Manual for Patient Monitor

3. Default Tubing Configuration

Sampling Dehumidification Sampling


Filter Sampling cell
adapter tubing tubing

Adapter and Sampling tube (Single patient use)

Extending airway tube for connecting to sampling tube (Single patient use)

Wye Connector

4. Optional sampling cannula kits

(1) T connector sampling cannula kits

On‐air Connector

Adapter
(2) Nasal Sidestream Cannula Kits

(3) Oral Sidestream Cannula Kits

95
Operator’s Manual for Patient Monitor

13.3.2 Mainstream CO2 Sensor Connection

Sensor cable

Adapter

CO2 sensor

Demonstration for Mainstream CO2 Sensor Connection

1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labeled “CO2” on the connector panel
of the monitor;
2. Snap the CO2 sensor onto the airway adapter. A “click” will be heard when the airway adapter is properly inserted.
3. Position the airway adapter in the patient’s respiratory circuit (as close to the patient as possible) between the
endotracheal tube and the ventilator circuit. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2
minutes for the sensor warm‐up.

☞ Always position the sensor with the adapter in an upright position to avoid collection of fluids on the windows of
the adapter. Large concentrations of fluids at this point will obstruct gas analysis.

13.4 Measurement Limitations


96
Operator’s Manual for Patient Monitor

The following factors may influence the accuracy of measurement:

 Leaks or internal venting of sampled gas

 Mechanical shock

 Cyclic pressure up to 10 kPa (100 cmH2O)

 Other sources of interference, if any.

13.5 Troubleshooting the Sidestream CO2 Sampling System


When the sampling system of the sidestream CO2 module works incorrectly, check if the sampling line is kinked. If not,
remove it from the watertrap. If the monitor gives a message indicating the airway still works incorrectly, it indicates
that the watertrap must have been blocked, and you should replace with a new one. Otherwise, you can determine
that the sampling line must have been blocked. Replace with a new sampling line.

13.6 Understanding the CO2 Display

CO2 panel (optional)

Unit of EtCO2 Label of Insired CO2

Label of CO2 and EtCO2 Label of Respiration rate

Value of EtCO2
Value of Respiration rate

Value of Insired CO2

 : the label and unit of EtCO2

 : the label of InsCO2

 mmHg: the unit of EtCO2 and InsCO2

 rpm: the unit of Respiration rate

 39.9 3.3 14: the value of EtCO2, InsCO2 and respiration rate

13.7 Changing CO2 Settings


When CO2 Monitoring is selected, the respiration parameter will be provided by CO2 module. That is, respiration
waveform area shifts to CO2 waveform area, respiration parameter area shifts to CO2 parameter area.

Select "Menu" → “CO2” to enter into CO2 related setting.

In RESP settings window, CO2 Settings can be entered if your monitor is configured with CO2 monitoring .

: click it to turn on or off CO2 Monitoring. When the CO2 monitoring is selected, then

97
Operator’s Manual for Patient Monitor

all items setting as "RESP" will shift to "CO2". See Chapter Monitoring Carbon Dioxide (CO2).

On RESP Settings screen, there is CO2 Monitoring Switch : click it to turn on or off CO2
Monitoring. It is recommended that the switch is turned on only when there is a need to monitor CO2 parameter. This
can not only reduce the power consumption and also extend the life of the CO2 measurement module.

In order to maintain the monitor, please set CO2 switch at OFF state in system setup when CO2 function is not used.

 Gain: the CO2 waveform gain. 4 options: X1/2, X1, X2 and X4. The default is X1 for adult and pediatric patient, and
X2 for neonate patient.

X1 waveform scale with base gain X1/2 half scale size of the base gain
X2 twice scale size of the base gain X4 four times scale size of the base gain

 Speed: Respiration waveform sweeping speed of, 2 options 6.25mm/s and 12.5 mm/s. The default is 12.5 mm/s.

 Apnea(s): The timeout setting for apnea alarm (in second).

(1). When CO2 monitoring is on:

It can be set as any number from 10 to 60 seconds, the step is 1 second. Icon " " displays on the
upper right corner of Respiration Panel; When the device has not detected any breathing signal for the
specified time, the “Apnea” alarm prompts on, and alarm sound will be activated. If it is set as OFF, the icon

" " displays on lower left corner of the Respiration Panel. The default is 20s.

(2). When CO2 monitoring is off: refer to Section Changing RESP setting.

 Source: Respiration signal source. This item is fixed to be "CO2" if CO2 monitoring function is selected. Otherwise,
the source will be obtained from thoracic impedance measurement from ECG module.

 Zero: press it to perform zero reset.

 Default: resume to the factory default value.

 Unit: It can be set up as "%", "kPa" and "mmHg". If the unit is changed, then the parameter value will change and
refresh timely. The unit will be displayed on parameter area, the default is "mmHg".

 Period: setting the calculating cycle of the EtCO2 value, there are three selectable options: "1b", "10s" and "20s".
The default is "10s". "1b" means the EtCO2 value will be calculated once every respiration cycle; "10s" means the
EtCO2 value will be calculated once every 10 seconds, and the maximum EtCO2 value measured during this 10s will
be displayed on data area; "20s" means the EtCO2 value will be calculated once every 20 seconds, and the
maximum EtCO2 value measured during this 20s will be displayed on data area.

 Balance: setting the balance gas in patient's respiration air flow. There are three kinds of selectable balance gas:
"Air", "N2O" and "He", namely: air, nitrous oxide and helium. If no specific balance gas is given, the balance gas
can be set as "Air".

 O2 Comp.: adjusting the concentration of the compensating gas in patient's respiration air flow. Generally, the
compensating gas is Oxygen, so it can be called oxygen compensation concentration. The unit: %; Setting range:
1~100%. Default value: 16.

98
Operator’s Manual for Patient Monitor

 TEMP (℃): setting the temperature value of the current measured air flow. For instance, the temperature is
usually set as 37℃while measuring the patient's respiration by air flow. However, if the air flow to be measured is
the reference gas, the temperature is set as 25℃. The setting range: 0.0 ~ 50.0; Unit: ℃; Default value: 35.0℃.

 Agent: setting whether adding the anesthetic gas to patient's respiration air flow and the concentration of
anaesthetic gas. The setting range is 0.0%~20.0%, the default status is: not adding anaesthetic gas, that's to say,
the concentration is 0.0%.

 Flow (CO2 flow): It is flow rate of the CO2 sampling. Its value is 50ml/min.

 Barometric (Barometric pressure): set ambient atmospheric pressure. It can be determined by barometer or the
ambient altitude. Altitude can be used to determine the typical barometric pressure if a barometer is not
available, refer to Appendix Typical Pressures and CO2 Readings at Altitudes for details.

 Zero: Press it to perform Zero Reset, then the prompt pops up on the window. Please note that the sample unit of
the CO2 sensor must be placed in a drafty place. Then press on "Start Zero" button to perform zero‐resetting,
then screen shows the current calibration status.

Three effective calibration status: 1. Zeroing 2. Zero success 3. Zero fail


 The information prompts during Zero calibration, but there is no audible and visual alarm.

 When perform a zero calibration during the measurement, disconnect the transducer from the patient’s airway
first.

 Please do not rely on the readings during zeroing.

99
Operator’s Manual for Patient Monitor

Chapter 14 Monitoring Cardiac Output (C.O.)


14.1 Introduction
The Cardiac Output (C.O.) function invasively measures cardiac output and other hemodynamic parameters by use of
the right heart (atria) thermodilution method. A cold solution with known volume and temperature is injected into the
right atrium through the proximal port of a pulmonary artery (PA) catheter. The cold solution mixes with the blood in
the right ventricle and the change in blood temperature is measured with a thermistor at the distal end of the
catheter in the pulmonary artery. The temperature change is displayed as a curve in the C.O. split screen, and the
monitor calculates the C.O. value from this curve. The C.O. value is inversely proportional to the area under the curve.

14.2 Safety Information


 Use the C.O. accessories specified in this manual only. Make sure that the accessories never come into contact
with conductive parts.

 As cardiac output varies continuously, a series of measurements must be carried out to achieve a reliable C.O.
average value, and always use the average of multiple thermodilution measurements for therapy decisions.

14.3 Setting Up the C.O. Measurement


 Use any accessories specified in this manual. Make sure that the accessories never come into contact with
conductive parts.

If your monitor is configured with Plugin C.O. Module, then you need to make sure that the C.O. Plug‐and‐Play box
is securely inserted. If the box is inserted successfully, then the C.O. icon appears on the upper right side of the
screen. Refer to the following description.

If your monitor is configured with internal C.O. Module, then the C.O. icon appears on the upper right side of the
screen.

14.3.1 Understanding C.O. Icon and C.O. Plugin Box (Optional)

Preparation‐‐‐ C.O. Connection

C.O. Plug‐and‐Play box (Optional)

The optioned Plug‐and‐Play box can be only configured with C.O. Module, or configured with other modules, please
refer to the box in your hand. If the Plug‐and‐Play box is equipped with IBP function.

100
Operator’s Manual for Patient Monitor

Plug‐and‐Play box with C.O. function

Icon "C.O." on the box is the C.O. connector, the connector maybe different because of the different configuration,
please refer to the box in your hand.

Note:

 If you insert 2 same boxes into (eg. 2 boxes with C.O. function), then the second box will not be recognized. That's,

the monitor can recognize at most one C.O., one CO2 and 4 IBP. For some models, the icon " " will be displayed on

the screen if the C.O. function is recognized.

14.3.2 C.O. Measuring Procedure

1. Connect the cable to the C.O, connector on the monitor. connect the catheter and temperature probe to the C.O.
cable as shown in following Figure.

Catheter
Connect the C.O. cable to the C.O. connector

Connector for injectate


temperature probe
Cables

" " means connecting


with each other

Injectate temperature probe Injectate delivery system

14.3.3 The placing process of catheter

The conventional intubation for C.O. Measurement is placing the catheter from the vein under the clavicle, through
superior vena cava, right atrium, right ventricle, and finally to pulmonary artery. During the intubation, the position of
the catheter can be viewed by X‐Ray scanning or estimated blindly. Normally the IBP monitoring is used to estimate
the blind intubation, the blood pressure waveform is different at different position. The following figures show the
blood pressure waveforms at the position from right atrium (RA), through right ventricle (RV) to pulmonary artery (PA)
101
Operator’s Manual for Patient Monitor

and finally getting the pulmonary artery contract pressure (RACP).

IBP waveform at different position

1. The surgeon places the catheter into the patient artery. Based on the monitoring of IBP or X‐ray scanning, the
surgeon can determine the target position of the catheter.

2. On "Menu" screen, rotate the Navigator Knob and move the focus on the icon "Cardiac Output", press the knob to
enter C.O. measuring screen.

3. Set the parameters according to the type of catheter and the injecting condition.

4. Press "Start" button, and drop one injectate, then the measured result will be displayed. Take C.O. measurement in
multiple times, and get the average result.

5. Obtain other hemodynamic calculations.

14.4 Changing C.O. Settings


Preparing:

Before make measurement, please setup the corresponding parameters as following.

Select "Menu" → “C.O.” → “Parameter” to enter into C.O. parameter related settings.

102
Operator’s Manual for Patient Monitor

Floating Catheter:

 Brand: brand of the catheter.

 Model: model of the catheter.

 Computing constant: setting the correction constant according to the catheter's brand and model.

Injectate:

 Temp. Examin. Mode: temperature measuring method for the injectate. 2 options: Manual and Auto.

 Temperature: the temperature value can be input when the Temp. Examin. Mode is "Manual".

 Volume: injectate volume.

14.5 Understanding the C.O. Display


Select "Menu" → “C.O.” to enter into C.O. display.

103
Operator’s Manual for Patient Monitor

C.O. record list area

Display screen for C.O. Measurement

Description:

 Current status: the cable connection status and measuring status.

 Waveform area: displays blood temperature (BT) waveform.

 IT(℃): Injectate Temperature (the temperature of saline to be injected).

 BT(℃): Blood Temperature (the temperature of blood at the tip end of the catheter).

 C.I.(l/min/m2): Cardiac function Index (blood volume per min per m2, the normal value is 2.5‐4.0 l/min/m2).

 C.O.(l/min): Cardiac Output (blood volume per min, the normal value is 4‐8 l/min).

 Examin. records: displays the current and history result of C.O. measurement. These records will be lost if the
monitor is shut off. Procedure of reviewing examination records: Menu→History Records→C.O. List.

 " / ": select previous/next record.

 " " delete this record.

 Countdown: displays the left time to the next examination.

 "30s": time interval between two examinations.

 Start : move the focus on the icon "start" and press the Navigator Knob to start C.O. measurement.

 Stop: move the focus on the icon "stop" and press the Navigator Knob to terminate C.O. measurement.

 Parameters: to select the brand and type of the catheter and its correction constant, as well as the injectate
temperature and volume etc.. See Section Changing C.O. Settings

1. On “Cardiac Output” display screen, move the focus to icon "parameters" to enter into "Parameter Settings" screen.

104
Operator’s Manual for Patient Monitor

Select the brand and model of the used catheter, set the correction constant of this catheter, and the method to
measure injectate temperature or its temperature value, injectate volume. If there is no temperature probe
contained in C.O. cable kit, then the injectate temperature has to be measured and input manually, the measuring
method should be set as ”Manual". If the temperature probe is available in C.O. cable kit, then the injectate
temperature can be measured automatical, and the measuring method should be set as "Auto", i.e. it's unnecessary
to input the temperature value.

2. : Time interval setting. A submenu above the "Start", 4 options: 30s, 40s, 60s and 90s. This is the time
interval between two measurements, which can be set as desired operation.

C.O. Measurement

Note: Finishing setting, "ready" information prompts up on the screen. Otherwise, make sure that the cables are well
connected.

 Start: When the C.O. measurement preparation is ready, move the focus to the icon "Start" and press the
Navigator Knob to start measuring. Start to inject the saline when BT measurement value appears in BT waveform.
During injection, make sure that the injecting speed should be constant and the injection should be done within
30s.

 End: During measuring, move the focus on the icon "End" and press the Navigator Knob to terminate C.O.
measurement if necessary. If the device finishes the C.O. measurement normally, the result will be displayed and
saved in the history records as well, the counting down timer also starts. If the measurement result is
unacceptable, the user can delete it, then the average values will be updated automatically.

In C.O. Settings window, move the focus on C.O. record list area, rotate the navigator knob to one record and press it

can review the current record on C.O. waveform area, or the user can press " " and " " to review the records.

105
Operator’s Manual for Patient Monitor

C.O. waveform area

C.O. record list

Note: The current C.O. measurement result will be displayed in the table “Examin. records" and saved in history
records as well. When the device is shutdown, the content listed in the table "Examin. records" will be lost, but the
history records still exists in the database. The history record includes patient ID, measuring time, TI, TB, C.O., C.I., and
BT waveform as well.

 Average C.I.(l/min/m2): the calculated average C.I. for the past examination records.

 Average C.O.(l/min): the calculated average C.O. for the past examination records.

You can press " " button to delete the record if the tolerance is too large.

14.6 Factors Affecting C.O.Measurement


 Heart

A. Preload: the blood volume in the ventricle at the end of diastolic phase, which is related with the volume of
venous return and the residual blood. Normally the pulmonary capillary wedge pressure (PCWP, its normal value
is 6‐12mmHg, or 0.8‐1.6kPa) is regarded as the reliable indication for the preload in right ventricle.

B. Afterload: the resistance against blood ejection.

C. The myocardial contraction and its harmonization, the heart compliance and heart rate.

 Monitor

The type of catheter, the correction constant of this catheter, the temperature, volume and speed of injection.

106
Operator’s Manual for Patient Monitor

 Temperature of injectate solution,

 Volume of injectate solution,

 Patient’s baseline blood temperature,

 Patient’s inspiratory/expiratory cycle,

 Placement of catheter with relation to proximity of lung field,

 The catheter itself,

 The patient rhythm and hemodynamic status, and

 Any other rapid IV solutions which are infused while the C.O. measurement is being performed

The following are some technique suggestions to obtain accurate C.O.:

 Injectate solution must be cooler than the patient’s blood.

 Inject solution rapidly and smoothly.

 Inject at end expiration.

107
Operator’s Manual for Patient Monitor

Chapter 15 Monitoring Anaesthesia Gas (AG)


15.1 Introduction
The anaesthetic gas (AG) module measures the patient’s anesthetic and respiratory gases, and incorporates the
features of the O2 module as well.

The AG module determines the concentration of certain gases using the infrared (IR) light absorption measurement.
The gases that can be measured by the AG module absorb IR light. Each gas has its own absorption characteristic. The
gas is transported into a sample cell, and an optical IR filter selects a specific band of IR light to pass through the gas.
For multiple gas measurement, there are multiple IR filters. The higher the concentration of gas in a given volume the
more IR light is absorbed. This means that higher concentration of IR absorbing gas cause a lower transmission of IR
light. The amount of IR light transmitted after it has been passed though an IR absorbing gas is measured. From the
amount of IR light measured, the concentration of gas present can be calculated.

Oxygen does not absorb IR light as other breathing gases and is therefore measured relying on its paramagnetic
properties. Inside the O2 sensor are two nitrogen‐filled glass spheres mounted on a strong rare metal taut‐band
suspension. This assembly is suspended in a symmetrical non‐uniform magnetic field. In the presence of paramagnetic
oxygen, the glass spheres are pushed further away from the strongest part of the magnetic field. The strength of the
torque acting on the suspension is proportional to the oxygen concentration. From the strength of the torque, the
concentration of oxygen is calculated.

AG module can identify two anesthetic gases in a mixture automatically and distinguish between them according to
their contributions to the MAC value for display as the primary and secondary anesthetis agent.

15.2 Safety Information


 Avoid explosion hazard, do not use flammable anesthetic agent such as ether and cyclopropane for this
equipment.

15.3 Measurement Limitation


The following factors may influence the accuracy of measurement:

 Leaks or internal venting of sampled gas

 Mechanical shock

 Cyclic pressure up to 10 kPa (100 cmH2O)

 Other sources of interference, if any

15.4 Setting Up the AG Measurement


The following MultiGas means Anaesthetic Gas including.

If your monitor has MultiGas monitoring function, please follow the instructions below to perform MultiGas
monitoring on patient.

108
Operator’s Manual for Patient Monitor

15.4.1 Instruction for PHASEIN IRMA Mainstream Multigas Analyzer

The IRMA mainstream multigas probe is intended to be connection to other medical devices for display of real time
and derived monitoring data of CO2, N2O, O2 and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane
and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during
anaesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and
emergency medicine settings for adult, pediatric and infant patients.

It is NOT intended to be used as the only means of monitoring a patient. It shall always be used in combination with
other Patient Monitor and/or professional human judgments of patient condition. The IRMA probe is intended to be
used by trained and authorized health car processionals only.

1. Assembly Instruction for IRMA Mainstream Analyzer

Installation

1. Plug the IRMA connector into the IRMA input of host device and switch the power on.

2. Snap the IRMA probe on the top of the IRMA airway adapter. It will click into place when properly seated. Please
refer to the following figure.

3. A green LED indicates that the IRMA probe is ready for use.

4. Connect IRMA/airway adapter 15mm male connector to the breathing circuit Y‐piece.

109
Operator’s Manual for Patient Monitor

5. Connect IRMA/airway adapter 15mm female connector to the patient's endotracheal tube.

Alternatively, connect a HME (Heat Moisture Exchanger) between the patient's endotracheal tube and the IRMA probe.
Placing a HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapor and
eliminates the need of changing the adapter. It allows free positioning of the IRMA probe as well.

6. Unless the IRMA probe is protected with a HME always position the IRMA probe with the LED pointing upwards.

Placement of IRMA probe

When connecting the IRMA probe to an infant patient circuit, it is important to avoid a direct contact between the
IRMA probe and the infant's body.

If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant's body an insulation
material shall be placed between the IRMA probe and the body.

Warning: the IRMA probe is not intended to be in patient contact.

Pre‐use check

Always verify and check the gas readings and waveforms on the monitor before connecting the IRMA airway adapter

110
Operator’s Manual for Patient Monitor

to the breathing circuit.

Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway adapter.

Operating instruction

On MultiGas Setup screen, set the Switch to "ON" to start the PhaseIn MultiGas Analyzer.

2. LED status

Color of LED Information

Steady green light System OK

Blinking green light Zeroing in process

Steady blue light Anesthetic agent present

Blinking red light Check adapter

3. Zero Procedure

Warning: Incorrect probe Zeroing will result in false gas reading.

In order to secure high precision of the IRMA probe measurement the following zeroing recommendations should be
followed:

1). Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe, without connecting the airway
adapter tot the patient circuit, and then using the host instrument to transmit a Zero reference command to the IRMA
probe.

2). Special care should be taken to avoid breathing near the airway adapter before or during Zeroing procedure. The
presence of ambient air (21% O2 and 0% CO2) in the IRMA airway adapter is of crucial importance for a successful
Zeroing. If a "ZERO_REQ" alarm should be appear directly after a Zeroing procedure, the procedure has to be
repeated.

Caution: always perform a pre‐use check after Zeroing the probe.

1). IRMA AX+ probe

Zeroing should be performed every time the IRMA airway adapter is replaced, or whenever an offset in gas values or
an unspecified gas accuracy message is displayed.

2). Allow 30 seconds for warm up of the IRMA AX+ probe after power on and after changing the IRMA airway adapter
before proceeding with the Zeroing Procedure.

3). The green LED on the probe will be blinking for approximately 5 seconds while Zeroing is in progress.

4.Instruction for Safe Operation ‐‐‐ IRMA Mainstream


 The IRMA probe is intended for use by authorized and trained medical personnel only.
 The IRMA probe is intended only as an adjunct in patient assessment. It must be used in conjunction with other
assessments of clinical signs and symptoms.
 The IRMA probe must not be used with flammable anesthetic agents.

111
Operator’s Manual for Patient Monitor

 Disposable IRMA airway adapter shall not be reused. Reuse of the single use adapter can cause cross infection.
 The used airway adapter shall be disposed of in accordance with local regulations for medical waste.
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6ml dead space to the
patient circuit.
 Do not use the IRMA Infant airway adapter with adult as this may cause excessive flow resistance.
 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this may allow patient
secretions to block the adapter windows and result in incorrect operation.
 To keep secretions and moisture from pooling on the windows or oxygen sensor port, always position the IRMA
probe in a vertical position with the LED pointing upwards.

 Do NOT use the IRMA airway adapter with metered dose inhalers or nebulized medications as this may affect the
light transmission of the airway adapter windows.
 Replace the airway adapter if rainout/condensation occurs inside the airway adapter.
 Use only PhaseIn manufactured IRMA airway adapter.
 The IRMA probe is not intended to be in patient contact.
 Never sterilize or immerse the IRMA probe in liquid.
 The IRMA airway adapter is non‐sterile device. Do not autoclave the devices as this will damage it.
 Do not apply tension to the probe cable.
 Do not operate the IRMA probe outside the specified operating temperature environment.

15.4.2. Instruction for PHASEIN ISA Sidestream Analyzer

ISA sidestream analyzer is intended to be used for real time monitoring data of CO2, N2O and the anesthetic agents
(AA) Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane during anaesthesia, recovery and respiration care.
It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult,
pediatric and infant patients.

It is NOT intended to be used as the only means of monitoring a patient. It shall always be used in combination with
other vital signs monitoring and/or professional human judgments of patient condition. The ISA sidestream probe is
intended to be used by trained and authorized health car processionals only.

1. System Setting
1. Plug the ISA connector into the host device.

112
Operator’s Manual for Patient Monitor

2. Plug the Nomoline sampling line into the ISA input port.

3. Connect the gas outlet with the releasing system, or make the gas flow to the patient circuit.

4. Power on the monitor.

5. A green LED indicates that the ISA gas analyzer is ready for use.

6. Do pre‐use check following the section part.

2. Pre‐use Check
Before plugging the Nomoline sampling line into the respiratory circuit, please do the following operation:
1. Connect the sampling line to the LEGI.
2. Check whether the green light in LEGI is normal.
3. For ISA OR+ and ISA AX+: Check whether the gas (O2) reading is correct (21%).
4. Expiring gas towards the sampling line and check that the gas reading (CO2) and waveform are displayed on the
monitor.
5. Clogging the sampling line with finger for 10 seconds.
6. Check if the clogging alarm is displayed and red light in LEGI is blinking.
7. Check whether the patient circuit is hermetic.
3. LEGI Status

Color of LED Information

Steady green light System OK

Blinking green light Zeroing in process

Steady blue light Anesthetic agent present

Blinking red light Check sampling line

Steady red light Sensor error

4. Zero Procedure
Infrared gas analyzer requires to ensure the zero datum level of the monitoring data of CO2, N2O and the anesthetic
agents (AA). This zero calibration is called Zeroing.
ISA sidestream analyzer is intended to perform Self‐Zeroing by shifting the sampling gas from breathing circuit to
ambient environment. The device performs Zeroing once a day, and approximately 10 seconds while Zeroing is in
progress.
5. Instruction for Safe Operation ‐‐‐ ISA sidestream
 ISA sidestream analyzer is intended for use by authorized and trained medical personnel only.
 Use only PHASEIN manufactured Nomoline sampling line.
 The ISA sidestream analyzer must not be used with flammable anesthetic agents.
 The sampling line should be kept away from the patient's cervix to prevent any possible suffocation of the
patient.
 Reusing the one‐off sampling line is forbidden.

113
Operator’s Manual for Patient Monitor

 The used sampling line shall be disposed of in accordance with local regulations for medical waste.
 Do not use the Adult/Pediatric sampling line with infants as the adapter adds dead space to the patient circuit.
 Do not use the Infant sampling line with adult as this may cause excessive flow resistance.
 Do not use the ISA sidestream analyzer together with the metered dose inhaler propellants as this may cause the
bacilli strainer clogged.
 Zeroing success needs the gas analyzer existing in the ambient air (21% O2 and 0% CO2). Therefore, please place
the ISA on draughty position. During performing zeroing procedure, please avoid breathing around the ISA
sidestream analyzer.
 Nomoline sampling line and its interface are non‐sterile device. Do not autoclave the devices as this will damage
it.
 Never sterilize or immerse the ISA sidestream analyzer.
 The portable and mobile RF communications equipment will affect the measurement. Please make sure that the
ISA sidestream analyzer is used in the specified electromagnetic environment.
 ISA sidestream analyzer is intended to be used as a means of auxiliary device of monitoring a patient. It shall
always be used in combination with other Patient Monitor.
 Please change the sampling line if red light is blinking on LEGI or "Sampling line clogged" displays on the monitor.
 ISA sidestream analyzer is not intended to be used in MRI environment.
 Placing the device out of the MRI Room during MRI scanning.
 Unprecise measured result may cause if High frequency electro‐surgical device is used around the ISA or monitor.
 Do not operate the external self‐cool function of the ISA device.
 Do not eliminate the condensate by adding negative pressure (eg. Use injector to add negative pressure) to
Nomoline.
 The overed positive pressure or negative pressure inpatient's circuit will affect the flowing speed.
 To prevent the Analyzer from dropping on the patient, the ISA sidestream analyzer should be well placed.
 Do not apply tension to the cable of the ISA sidestream analyzer.
 Please fix the ISA "Plug and Play" analyzer to avoid causing damage on ISA sidestream analyzer.
 Do not operate the ISA sidestream analyzer outside the specified operating temperature environment.

114
Operator’s Manual for Patient Monitor

15.6 Understanding the AG Display


Waveform:

AG panel (optional):

Primary anesthetic gas


N2O concentration at
concentration at the end of tide
the end of tide

CO2 concentration at Secondary anesthetic gas


the end of tide concentration at the end of tide

Fraction of Inspired secondary


Fraction of Inspired
anesthetic gas concentration
CO2 concentration
Fraction of Inspired primary
Fraction of Inspired The minimum alveolar
Respiratory rate anesthetic gas concentration
concentration
N2O concentration

15.7 Changing AG Settings


Select "Menu" → “RESP” to enter into RESP related setting.

In RESP settings window, AG Settings can be entered if your monitor is configured with AG Monitoring.

On RESP Settings screen, there is AG Monitoring Switch : click it to turn on or off AG


Monitoring. It is recommended that the switch is turned on only when there is a need to monitor AG parameter. This
can not only reduce the power consumption and also extend the life of the AG measurement module.
In order to maintain the monitor’s service life, please set AG Monitoring switch at OFF state in system setup when
AG Monitoring function is not used.

 : when AG monitoring function is turned on, then “CO2 detection only” function can
be also turned on. Otherwise, it stays in grey and is nonadjustable. If “CO2 detection only” function is selected,
then all settings for AA1 and AA2 stays in grey and is nonadjustable.

115
Operator’s Manual for Patient Monitor

 Gain: the CO2 waveform gain. 4 options: X1/2, X1, X2 and X4. The default is X1 for adult and pediatric patient, and
X2 for neonate patient.

X1 waveform scale with base gain X1/2 half scale size of the base gain
X2 twice scale size of the base gain X4 four times scale size of the base gain

 Speed: Respiration waveform sweeping speed of, 2 options 6.25mm/s and 12.5 mm/s. The default is 12.5 mm/s.

 Apnea(s): The timeout setting for apnea alarm (in second).

(1). When AG monitoring is on:

116
Operator’s Manual for Patient Monitor

It can be set as any number from 20 to 60 seconds, the step is 1 second. Icon " " displays on the
upper right corner of Respiration Panel; When the device has not detected any breathing signal for the
specified time, the “Apnea” alarm prompts on, and alarm sound will be activated. If it is set as OFF, the icon

" " displays on lower left corner of the Respiration Panel. The default is 20s.

(2). When AG monitoring is off: refer to section Changing RESP Setting.

 Source: Respiration signal source. This item is fixed to be "AG" if AG monitoring function is selected. Otherwise,
the source will be obtained from thoracic impedance measurement from ECG module.

 Zeroing: press it to perform zero resetting.

 Default: resume to the factory default value.

 CO2 Unit: the unit of CO2 concentration. 3 options: kPa, mmHg and vol%. 1kPa=7.5mmHg. CO2 (mmHg) = (CO2
concentration (vol%) ) * (atmospheric pressure (kPa) ) * 7.5.

 Barometric: the detected atmospheric pressure, which can be set at the same time. The setting range is from
1~999(%), the default is 100(%).

 O2 density: Oxygen concentration setting.

 : the switch for displaying waveform of AA1 and AA2. Select it means
the AA1 and AA2 waveform will be displayed on the screen during monitoring.
 PARM: to enter into Anaesthesia Gas alarm setting. See Section “Understanding the Alarm Setting”.

117
Operator’s Manual for Patient Monitor

Chapter 16 Monitoring CSM


The CSM function can be achieved through the External CSM unit, the Built‐in CSM module, and the Plugin CSM
module.

16.1 Introduction
The Cerebral State Monitoring (CSM) is intended for use in monitoring the hypnotic state of the brain by data
acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. CSM is a non‐invasive
measurement tool to be used by a trained professional to measure the level of consciousness during general
anaesthesia and sedation by use of variations in the frequency content of the spontaneous EEG. It analyses the
frequency shifts that take place in the EEG signal as the level of consciousness changes. Based on this principle, the
device calculates the Cerebral State Index (CSI), which is used to estimate the level of consciousness of the patient.

16.2 Safety Information


 If used with High Frequency (HF) surgery please pay attention to the positioning of CSM electrodes. In order to
reduce the hazard of burns, the electrodes should not be located between the surgical site and the
electro‐surgical unit return sensor.
 The conductive parts of sensors and their connectors, including the neutral sensor, should not contact other
conductive parts including earth and ground.
 The monitor will not render accurate reading when used on patients with severe neurological disorders and
patients under 2 years old.
 The use of pacemakers might cause either long periods of artefacts or elevated CSI values.
 If skin rash or other unusual symptoms are developed, remove sensors from patient.
 Ethanol is not recommended as a skin cleanser, for it leaves a film layer that may cause high sensor impedance.
 If used with High Frequency surgery during CSM monitoring, then artefacts or elevated CSI value may be caused.

16.3 Understanding CSM Parameters


 CSI
The performance of the CSM is based on the analysis of the frequency content of the EEG signal.

The energy of the EEG is evaluated in specific frequency bands. These are used to define two energy ratios called
alpha (α) and beta (β). Both of these show a shift in energy content from a higher to the lower frequencies during
anaesthesia. The relationship between these quantities is also analysed as a separate parameter (β‐α).

αratio=ln(E30-42.5Hz/E6-12Hz)
βratio=ln(E30-42.5Hz/E11-21Hz)
The monitor also on‐line evaluates the amount of instantaneous burst suppression (BS) in each thirty‐second
period of the EEG. This measurement quantifies the amount of “silent” or “flat” EEG period characteristic of the

118
Operator’s Manual for Patient Monitor

deepest levels of hypnosis.

These four parameters are used as input to a fuzzy logic classifier system that calculated the Cerebral State Index.

 CSI Scale
The CSI is a unit‐less scale from 0 to 100, where 0 indicates a flat EEG and 100 indicates EEG activity corresponding
to the awake state. The range of adequate anaesthesia is designed to be between 40 and 60. All values in the
table are approximate values based on the mean values of the patient behaviour.

 EMG
Facial EMG may increase the CSI under certain conditions. The monitor incorporates an EMG filter that removes most
of the potential interfering EMG activity. The EMG% bar shows the energy of the EMG level in the 75‐85 Hz frequency
band (0‐100 logarithmic). The bar is located on the right side of the display.

EMG activity is expected to be present when the patient is awake. When the patient is asleep, EMG activity can
increase due to:

 Reflex reactions to painful stimuli during surgery.

 Lack of muscular relaxation.

 Muscular rigidity caused by some opioids (analgesics).

 Presence of large external electrical fields, e.g. diathermy.

The EMG bar should be checked frequently, especially in case of a sudden increase in the CSI. If the increase in CSI is
accompanied by an increase in muscular activity, there is a risk that EMG is causing interference. When this happens,
attention must be paid to the stimuli receive by the patient during surgery. In the presence of hypnotically unrelated
EMG, administration of a neuromuscular blocking agent will cause the CSI to decrease. Since patients receiving
neuromuscular blocking agents cannot exhibit movement as a sign of arousal, the CSI is a valuable tool in their

119
Operator’s Manual for Patient Monitor

anaesthetic management.

 BS% Indicator
The monitor includes a Burst Suppression indicator to show periods when the EEG is iso‐electric or “flat”. The
indication appears in the upper left‐hand side of the graph window in the display and shows the percentage of burst
suppression over the last 30 seconds of the EEG signal. A BS%=20 readouts means that the EEG has been iso‐electric
during 20% of the last 30 seconds.

 Signal Quality Indicator (SQI%)


SQI% measures the quality of the acquired EEG signal. The calculation is based on a number of artifacts during the last
minute. The quality is displayed numerically as a percentage (0‐100%, 100%equals best signal quality) in Display Mode
A.

 Sensor Impedance
The impedance of the white and black sensors is continuously measured and displayed in Display Mode C. Low sensor
impedance values (typically between 1 and 3 kΩ) are essential for good monitor operation. A “<1 kΩ” readout means
that sensor impedance is optimal.

 Sensor Alarm
The Sensor Alarm signals the interruption of reliable CSI calculation due to corrupted or interrupted EEG. This is usually
caused by the use of diathermia or a faulty sensor connection (high sensor impedance or disconnection of sensor
leads). Should any o these situations occur, the RED Error light (2) will turn on. The CSI is not calculated during these
periods.

16.4 CSM Processes


 Operation procedure for external CSM unit:
Step 1: Prepare the skin, place and connect sensors to the CSM patient cable.

Step 2: Connect patient cable to the CSM unit and ensure that its battery is available.

Step 3: Press the Power On button of CSM unit.

Note:

Always select a CSM Link ID (Serial No.) before turning on the CSM unit. When turn on the CSM unit, the CSM unit
shows a list of CSM Links found, select the one corresponding to the serial number displays on the right side panel of
the patient monitor (with the Event Key (8)), and then press the Set Event key (6) to accept it. When link has been
established the indicator Link will show a constant light.

If CSM Link connected the CSM Link serial number and software version will be shown. “‐ ” indicates no CSM Link
connected.

It's strongly recommended to follow the specified steps and procedures for operation in order to obtain better signal
quality and accurate measurement result.

 Operation procedure for CSM Plug‐in Module:


Install CSM Plug‐in box→Clean and prepare skin→Place the electrodes→Connect lead wires to CSM Plug‐in box.
Step 1: make sure CSM Plug‐in box is installed successfully

120
Operator’s Manual for Patient Monitor

Step 2: clean and prepare skin


It's recommended that the skin‐electrode impedance should be less than 2k ohm in order to obtain good signal quality.
Before placing the sensors, the user should clean the skin with mild soap, and prepare the skin to remove the
non‐conductive layer of the skin by filing off it with the sandpaper on the provided electrode.

Different skin conditions need different preparations:

Case (1): for the female with make‐up

Smear the cleanser on the skin and wipe out the make‐up at first, then wait for its evaporation. After that, rubbing the
skin 2 or 3 times with the sandpaper on the provided electrode, and clean up the rest substance with cotton or gauze.
Lastly, placing the electrodes.

Case (2): for those with oily skin

Smear the Ethanol on the skin and wipe out the oily substance at first, then wait for its evaporation. After that,
rubbing the skin 2 or 3 times with the sandpaper on the provided electrode, and clean up the rest substance with
cotton or gauze. Lastly, placing the electrodes.

Case (3): for pediatric patient

Smear the clear water on the skin at first, then clean the skin with cotton or gauze. Lastly placing the electrodes.

Step 3: place the electrodes

The placement of three electrodes is shown below. The advanced signal processing technique ensures that the
distance between electrodes can be as close as 2 cm (0.78 in) to get correct CSI value. However, it is recommended to
place the electrodes on the skull area with few muscle fibrils in order to obtain better signal quality.

Middle of forehead

Left side of forehead

Note:

Once the electrodes have been secured on the skin, attach the color‐coded wires on the patient cable to appropriate
electrode.

Shown above is a left sided setup; right sided is also acceptable.

Place electrodes at the side farthest from the surgical area.

Step 4: connect lead wires to CSM Plug‐in box

Make sure that the lead wires of CSM is well connected. Connecting one end to the electrode and another end to CSM
Plug‐in box.

121
Operator’s Manual for Patient Monitor

16.5 Changing CSM Settings


Select “Menu” → “CSM” to enter into CSM related setting.

Mark Event

 The latest event: the latest event can be "General", "Intubation", "Surgery", "Note", "Movement", "Induction",
"Maintenance", "Injection" and "End Maintenance".

 Renumber: renumber the current selected event type.

 EEG Range: set the EEG amplitude range, the range is 20, 40, 80 and 160, the default is 80.

 PARM: to enter into CSI alarm setting. See Section “Understanding the Alarm Setting”.

122
Operator’s Manual for Patient Monitor

Chapter 17 Review
Press the "Review" button on statusbar to enter into the History Records window, including waveform information,
trend data and event list, as shown in following Figure.

Refer to the actual window

In "Review" window, select the patient record you want to review, the following data record can be viewed:
Arrhythmia (ARR) event, Trend graphs, NIBP List, ECG Waveforms, Alarm events, SpO2 events and CSM Records
(optional).

Select one of the patient list on the left window, and press the related button to review the corresponding
information.

Patient list: including PID (Patient ID), name, birth date, group.

Data Review button: including ARR Event, Trend Graph, NIBP List, ECG Wave, Alarm Event and SpO2 Event.

17.1 ARR Events


“Search” button: search the ARR Event records in the specified date.

In the numeric box of "Month", "Day" and "Year", select the specified date, and press "Search" button to review the
event list in specified date.

The numeric box "Day" can be set as “All”, it means all the month. The numeric box "Month" can also be set as “All”, it
means all the year.

Note: all event list can be searched by date, we will not cover it later again.

123
Operator’s Manual for Patient Monitor

17.2 Trend Graph


The "Trend Graph" window is as shown in following Figure.

Trend Graph window

Parameter: select a parameter to review its graph, options are: HR, SpO2, RR, S‐T, TEMP, CO2 and so on

Sampling interval: sample time interval of the trend graph, 7 options: 1 second, 5 seconds, 10 seconds, 30 seconds, 1
minute, 5 minutes and 10 minutes.

Positioning: positioning mark is a data point that the cursor line (a blue vertical line) locates on the trend graph. And
the table on the lower window shows the detailed information (date, time, HR, SpO2, and etc.) of the time point
where the Positioning Mark located.

Operation for the Cursor line: move the cursor line to the left and right. The step is 1 pixel initially, but it will be
increased to 8 pixels by rotating of Navigation Knob in one direction more than 30 steps. If the step is 8 pixels, rotating
of Navigation Knob in opposite direction will make step to 1 pixel. Press down Navigation Knob to exit from
“Positioning” mode.

Note: on Short Trends view, the general waveform is on the left of waveform area and the short trend view on the
right.

17.3 NIBP List


A NIBP record not only consists of the blood pressure data, i.e. SYS (systolic pressure), DIA (diastolic pressure), MAP
(mean arterial pressure), but it also includes data of PR, RR, S‐T, SpO2, Temp1, Temp2 and etc., stored at the
measurement time.

124
Operator’s Manual for Patient Monitor

“Search” button: search the NIBP records in the specified date.

“Trend graph” check‐box: makes the trend graph of NIBP records visible or invisible as shown in following Figure.

NIBP trend graph window

"S", "D", "M": is the abbreviation for Systolic pressure, Diastolic pressure and Mean arterial pressure. The letter color
is the same as the its waveform color.

xx/yy: the current record number/ total records.

17.4 ECG Waveforms


The device can store the latest ECG Waveforms Records more than 72 hours. All ECG Waveforms Records are listed on
the left part of the window. The selected ECG waveform Record (in the blue frame) are displayed on the right.

Selecting from drop‐down box “ ” can change the ECG lead. The ECG leads options are ECG I, ECG II,

ECG III, ECG aVR, ECG aVL, ECG aVF and ECGV.

There may be several pages for an ECG waveform record (10 seconds for one page). Use page‐turn buttons

to review pages

“xx/xx” means “Page No. / total pages”.

17.5 Alarm Event


Each Alarm Event record consists of Time (the time when alarm occurs), Level (alarm level), Param (the parameter

125
Operator’s Manual for Patient Monitor

activates alarm), Value (the value of the parameter when alarm occurs), the preset high and low alarm limit setting
value.

There are 2 alarm categories: Parameter Alarm and Technical Alarm (refer to alarm section for details in Section
Alarm).

There are 3 alarm Levels: High priority, Medium priority and Low priority corresponding to high risk, medium risk and
low risk respectively.

17.6 SpO2 Event


If the patient’s SpO2 value decreased by certain value in a short time, it will be defined as a SpO2 Event.

A SpO2 Event record includes the Time (the time when the event occurs), Minute‐average, SpO2 value (the current
SpO2 value), HR, PR and RR.

17.7 CSM Records (Optional)


CSM records can be reviewed by “Trends” and “Events”.

The default "CSM Records" reviewing window is by "Trends". All CSM records (including CSI, SQI, EMG% and BS%) and
EEG of the current patient can be reviewed.

CSM trend graph recall

CSM record‐‐‐by Trends

In the window as shown in above Figure, the positioning measurement of the CSM trend graph can be entered. The
measured value that the cursor line indicates will be displayed on the lower right side, for example,

" ", and the EEG waveform will be displayed on the lower middle side, for

126
Operator’s Manual for Patient Monitor

example, " ". That's the positioning measurement for CSI, SQI, EMG%, BS% and EEG.

" ": The event mark. The number is the event No., the letter is the event type. The event type description is as
below:

G: General U: Intubation S: Surgery N: Note

M: Movement I: Induction C: Maintenance J: Injection

E: End Maintenance

Sampling Interval: sample time interval of the trend graph, 6 options: 1 second, 5 seconds, 10 seconds, 30 seconds, 1
minute and 5 minutes.

The current event records can be reviewed by "Events"

CSM record‐‐‐by Events

If reviewed the CSM records by Events, then the event No., event time and event type will be listed on the "CSM
Records" window.

17.8 C.O. History Record Review

127
Operator’s Manual for Patient Monitor

CSM Record List

Description:

Select a date including "Year", " Month" and "Day" by rotating and pressing the Navigator Knob. Move the focus on

the icon " " and press Knob to enter into the screen to review the patient's CSM List, including IT, BT, CI,
C.O.

On CSM Record window, press Print key to print all CSM record list shown on the current window.

If " " is select, then the current selected CSM recorded data and waveform will be
printed.

128
Operator’s Manual for Patient Monitor

Chapter 18 Calculations
18.1 Introduction
The calculation feature is available with your monitor. The calculated values, which are not directly measured, are
computed based on the values you provide.

You can perform the following calculations:

 Medicine Dose calculations

 Oxygenation calculations

 Ventilation calculations

 Hemodynamic calculations

 Renal calculations

18.2 Safety Information


 After the calculation is finished, verify the entered values are correct and the calculated values are appropriate.
We assume no responsibility for any consequences caused by wrong entries and improper operations.
 The calculation feature is independent of other monitoring functions and can be therefore used for patients
being monitored by other monitors. Any operation in a calculation window does not affect the monitoring by the
local monitor.

18.3 Medication Calculation (Medicine Dosage Calculation)


In "Menu" window, the Medication Calculation window can be entered.

129
Operator’s Manual for Patient Monitor

Medicine Dosage Calculation window

This monitor provides the dosage calculation for 10 kinds of medicine, including: AMINOPHYLLINE, DOBUTAMINE,
DOPAMINE, EPINEPHERINE, HEPARIN, ISUPREL, LIDOCAINE, NIPREL, NITROGLYCERIN and PITOCIN.

 Medicine Dosage Calculation applies the following Formulas:

MC = Gross ÷ Cubage

(D/m) = (D/h) ÷ 60

(D/Kg/m) = (D/m) ÷ Weight

(D/Kg/h0 = (D/h) ÷ Weight

DS = TS ÷ (Cubage/drop)

Duration = Gross ÷ (D/h)

 Items definitions:

MC: medicine consistency;

(D/m): dosage per minute;

(D/h): dosage per hour;

(D/Kg/m): dosage per kilogram per minute;

DS: drop speed;

130
Operator’s Manual for Patient Monitor

TS: titration speed

(D/Kg/h): dosage per kilogram per hour;

Gross: medicine gross;

Description:

All items in formulas above are consistent with those in the Medicine Calculation Window.

In the Medicine Calculation Window, only “Medicine” and “Weight” are input items, all others are output items.

 Medicine: to select a medicine type;

 Weight: to set the weight of a patient for calculation, the patient here is not the current patient being monitored
right now. The weight can be set from 0.5kg to 300kg. Its interval is 0.5kg. The defaults are 70kg for Adult, 20kg
for Pediatric, 3.0Kkg for Neonate

 Other output items: except “Medicine” and “Weight” items, all other items are outputs. Generally, they are not
needed to be adjusted after calculation. However, they can be fine‐tuned practically. All other items results will
be updated accordingly when an item fine‐tuned.

 Operation steps:

(1) Select a “Medicine”, e.g. AMINOPHYLLINE;

(2) Set a “Weight”, e.g. 70.00 kg;

(3) Any change in “Medicine” or “Weight” will cause the system to calculate all output items and display them
on screen automatically.

Because each output item has its own valid range, it will be displayed as "…" when the calculating result exceeds its
range.

 Medicine: select one of the medicines: AMINOPHYLLINE, DOBUTAMINE, DOPAMINE, EPINEPHERINE, HEPARIN,
ISUPREL, LIDOCAINE, NIPREL, NITROGLYCERIN and PITOCIN. The default is AMINOPHYLLINE.

 Weight: when entering into medicine calculating window, the operator should enter patient’s weight; the weight
is used for MC calculation only; weight: 0.5Kg to 300Kg selectable; step: 0.5Kg; default: 70 Kg for adult; 20Kg for
pediatric; 3.0 Kg for neonate.

 The medicine applies the fixed unit, or a fixed family of units. The operator must select the appropriate unit
according to doctor’s advices. In a unit family, the carry between 2 adjacent units performs automatically along
with the current inputs. When the space on screen for an item is not enough to display all digits of the item in a
certain unit, it will be displayed as “…”.

 In neonate mode, “DS” and “Drop” items are ignored.

 Note: the patient here has nothing to do with the current patient monitoring right now, and only for Medicine
Calculation.

Titration :

When the concentration calculation of a medicine is OK in the first tab, the Titration Table in the second tab
(“Titration”) can be browsed. The Titration is a “Dose ‐ Drop Speed” or a “Dose ‐ Titration Speed” cross‐reference list.

131
Operator’s Manual for Patient Monitor

Titration window

There are 3 editable boxes on the lower left of the window for retrieve of Titration Table in details.

 Reference: to make item as the independent variable, other items will be dependent variables. There are 3
options: “Dose”, “DS‐Drop Speed” and “TS‐Titration Speed”;

 Step length: the gap between two adjacent values, its range is 1~10, step is 1;

 Dose Type: choose the type of dose 4 options: /h, /m, /Kg/h, /Kg/m. The changing of unit will cause the
re‐calculation of Drop Speed and Titration Speed according to formulas mentioned in the above section

 "[1/1]": the number on the lower part is the current page/total pages.

18.4 Oxygenation Calculation


From "Menu" window, the “Oxygenation Calculation” window can be brought up.

132
Operator’s Manual for Patient Monitor

Oxygenation calculation window

The input items include C.O.(Cardiac output), FiO2 (Fraction of inspired oxygen), PaO2 (oxygen partial pressure), PaCO2
(carbon dioxide partial pressure), Hb (Hemoglobin), CaO2(oxygen content of arterial blood), CvO2 (oxygen content of
mixed blood), VO2 (oxygen consumption), RQ (Respiratory quotient), ATMP (Atmospheric pressure), Height and
Weight.

Refer to the following table for the detailed definition, unit and adjustable range of the input items.

Input item Unit Definition Adjustable range

C.O L/min Cardiac output 0.1—20.0

FiO2 % Fraction of inspired oxygen 18%‐‐100%

PaO2 mmHg Oxygen partial pressure 10—800

PaCO2 mmHg Arterial carbon dioxide tension 0—200

Hb g/L Hemoglobin 50—200

CaO2 ml/L Oxygen content of arterial blood 10—400

CvO2 ml/L Oxygen content of mixed blood 10—400

VO2 ml/min Oxygen consumption 50—1000

RQ —— Respiratory quotient 0.1—1.5

ATMP mmHg Atmospheric pressure 300—1200

H cm Height 20—300

133
Operator’s Manual for Patient Monitor

W kg Weight 1.0—250.0
Oxygenation calculation function can perform calculation for 14 parameters (i.e. Output items): BSA (body surface
area), VO2 calc (oxygen consumption), C(a‐ v)O2 (oxygen content difference between artery and vein), O2ER (oxygen
extraction rate), DO2 (oxygen delivery), PAO2 (oxygen pressure in alveolar ), AaDO2 (oxygen pressure difference
between alveolar and artery), CcO2 (pulmonary capillary oxygen content), Qs/Qt (intra‐pulmonary shunt rate), C.O.calc
(calculated cardiac output), PaO2 / FiO2 (oxygenation index), AaO2 / PaO2 (Ratio of alveolar‐arterial oxygen partial
pressure difference to oxygen partial pressure), DO2l (oxygen delivery index) and VO2l (oxygen consumption index).

Refer to the following table for the detailed definition, unit and adjustable range of the output items.

Parameters Definition Calculation formula Unit Range

BSA Body surface area W0.425 *H0.725*0.007184 m2 ——

VO2 calc Oxygen consumption (SaO2‐SvO2)*13.4*Hb * C.O. ml/min ——

C(a- v)O2 Oxygen content difference CaO2 – CvO2 ml/L 42~59

between artery and vein

O2ER Oxygen extraction rate VO2(CaO2‐CvO2)*100% % 24~28

DO2 Oxygen delivery CaO2 * C.O. ml/min 950~1150

PAO2 Oxygen pressure in alveolar (FiO2*100)*(ATMP ‐ 47) – PaCO2 / RQ) mmHg ——

AaDO2 Oxygen pressure difference (FiO2*100)*(ATMP ‐ 47) – (PaCO2 / RQ) mmHg 10~15
between alveolar and
artery - PaO2

CcO2 Pulmonary capillary oxygen (Hb*1.34)+(((FiO2*100)*(ATMP ‐ 47) – ml/L ——


content
(PaCO2 / RQ))* 0.0031)

Qs /Qt Intra‐pulmonary shunt rate {[(Hb*1.34)+(( (FiO2*100)*(ATMP‐47)–(P % 3.0~5.0

aCO2/RQ))* 0.0031)] - CaO2) /

{ [(Hb*1.34)+(( (FiO2*100)*(ATMP‐47)–(

PaCO2/RQ))* 0.0031)] – CvO2 }*100

C.O.calc Calculated cardiac output VO2 / (CaO2‐CvO2) L/min 0.1~20.0

PaO2 / FiO2 Oxygenation index PaO2 / (FiO2*100) mmHg ——

AaO2 / PaO2 Ratio of alveolar‐arterial [(FiO2*100)*(ATMP ‐ 47) – (PaCO2 / RQ) —— ——


oxygen partial pressure
difference to oxygen partial - PaO2 ] / PaO2
pressure
DO2l Oxygen delivery index (CaO2 * C.O.)/BSA ml/min/m2 ——

VO2l Oxygen consumption index (CaO2 – CvO2)*C.O. /BSA ml/min/m2 ——


Operations:
Entering the value for each input item, and click “Calculate”, and the monitor will calculate the parameter according to

134
Operator’s Manual for Patient Monitor

the calculate formula, the result will be displayed on the screen. then click “Range” to view the range for each
parameter.

Notes:

1) The result for each parameter will be shown as “‐‐‐” before click “Calculate” button.

2) The calculation result will be shown in yellow if the result is beyond the reference range.

Result Unit

Oxygenation calculation‐‐‐Calculate result

135
Operator’s Manual for Patient Monitor

Range

Oxygenation calculation‐‐‐Reference range

18.5 Ventilation Calculation


From "Menu" window, the “Ventilation Calculation” window can be brought up.

Ventilation calculation window

The input items include FiO2 (fraction of inspired oxygen), RR (respiratory rate), PeCO2 (end‐tidal CO2 pressure), PaCO2
136
Operator’s Manual for Patient Monitor

(carbon dioxide partial pressure), PaO2 (oxygen arterial pressure), TV (tidal volume), RQ (respiratory quotient), ATMP
(atmospheric pressure).

Refer to the following table for the detailed definition, unit and adjustable range of the input items.

Input item Unit Definition Adjustable range

FiO2 % Fraction of inspired oxygen 18% ‐‐100%

RR rpm Respiratory rate 4—120

PeCO2 mmHg End‐tidal CO2 pressure 0—114

PaCO2 mmHg Carbon dioxide partial pressure 1—200

PaO2 mmHg Oxygen partial pressure 10—800

TV ml Tidal volume 15—2000

RQ Respiratory quotient 0.1—1.5

ATMP mmHg Atmospheric pressure 300—1200

Ventilation calculation function can perform calculation for 9 parameters (i.e. Output items): PAO2 (oxygen pressure in
alveolar), AaDO2 (oxygen pressure difference between alveolar and artery), PaO2 / FiO2 (ratio of expired oxygen
pressure to inspired oxygen pressure), Pa/AO2 (ratio of oxygen pressure in artery to alveolar), AaDO2 / PaO2
(respiratory index), MV (minute ventilation), Vd (dead space ventilation), Vd/Vt (physiological dead cavity) and VA
(alveolar ventilation).

Refer to the following table for the detailed definition, unit and adjustable range of the output items.

Parameters Definition Calculation formula Unit Range

PAO2 Oxygen pressure in alveolar FiO2*(ATMP ‐ 47) – (PaCO2 / RQ) mmHg ——

AaDO2 Oxygen pressure difference FiO2*(ATMP ‐ 47) – (PaCO2 / RQ) - PaO2 mmHg ——
between alveolar and artery

PaO2 / FiO2 Ratio of expired oxygen PaO2 / FiO2 mmHg ——


pressure to inspired oxygen
pressure

Pa / AO2 Ratio of oxygen pressure in PaO2/( FiO2*(ATMP ‐ 47) – (PaCO2 / RQ)) % ——


artery to alveolar

AaDO2 / PaO2 Respiratory index (FiO2*(ATMP ‐ 47) – (PaCO2 / RQ)-PaO2)/ —— ——


PaO2

MV Minute ventilation TV * RR / 1000 L/min ——

Vd Dead space ventilation ((PaCO2‐PeCO2)/PaCO2)*TV ml 145~155

Vd/Vt Ratio of dead‐space ((PaCO2‐PeCO2)/PaCO2)*100% % 25~40


ventilation to tidal ventilation

(Physiological dead cavity)

137
Operator’s Manual for Patient Monitor

VA Alveotar ventilation (TV ‐ ((PaCO2‐PeCO2)/PaCO2)*TV) * RR L/min ——

Operations:

Entering the value for each input item, and click “Calculate”, and the monitor will calculate the parameter according to
the calculate formula, the result will be displayed on the screen. then click “Range” to view the range for each
parameter.

Notes:

3) The result for each parameter will be shown as “‐‐‐” before click “Calculate” button.

4) The calculate result will be shown in yellow if the result is beyond the reference range.

Result Unit

Ventilation calculation‐‐‐Calculate result

138
Operator’s Manual for Patient Monitor

Range

Ventilation calculation‐‐‐Reference range

18.6 Renal Function Calculation


From "Menu" window, the “Renal Function Calculation” window can be brought up.

Renal function calculation window

The input items include URK (urine kalium), URNa (urine natrium), Urine (24 hours urine), Posm (plasma osmotic
pressure), Uosm (urine osmotic pressure), SerNa (serum natrium), SCr (serum creatinine), UCr (urine creatinine),
139
Operator’s Manual for Patient Monitor

BUN(blood urea nitrogen), Height and Weight.

Refer to the following table for the detailed definition, unit and adjustable range of the input items.

Input item Definition Adjustable range Unit

URK Urine Kalium 1—9999 mmol/L

URNa Urine Natrium 0—9999 mmol/L

Urine 24 hours Urine 0—5000 ml/24h

Posm Plasma osmotic pressure 100—500 mOsm/kgH2O

Uosm Urine osmotic pressure 200—2000 mOsm/kgH2O

SerNa Serum Natrium 50—300 mmol/L

SCr Serum Creatinine 45—90 umol/L

UCr Urine creatinine 100—50000 umol/L

BUN Blood urea nitrogen 0—10 mmol/L

Weight Patient’s weight 20—300 cm

Height Patient’s height 1—250 kg

Rental function can perform calculation for 11 parameters (i.e. Output items): URNaEx (urine natrium excretion),
URKEx (urine nalium excretion), Na/K (excretion ratio of urine sodium and kalium), CNa (natrium clearance), Clcr
(creatinine clearance), FENa (fractional excretion of sodium), Cosm (osmolar clearance), CH2O (free water clearance),
U/Posm (ratio of Urine to Plasma osmotic pressure), BUN/Scr (ratio of blood urea nitrogen to serum creatinine), and
U/SCr (ratio of urine creatinine to serum creatinine) .

Refer to the following table for the detailed definition, unit and adjustable range of the output items.

Parameter Definition Formula Unit Range

URNaEx Urine Natrium excretion URNa *Urine/1000ml mmol/24h 51~102

URKEx Urine Kalium excretion URK * Urine /1000ml mmol/24h 130~260

Na/K Excretion ratio of Urine URNa / URK * 100% % ——


Sodium and Kalium

CNa sodium clearance (URNa * Urine)/SerNa mmol/24h ——

Clcr Creatinine clearance (Urine * UCr)/(SCr * 1440) ml/min 80~120

FENa Fractional excretion of sodium ( URNa * Scr ) / (SerNa * UCr ) * % ——


100%

Cosm Osmolar clearance (Uosm * Urine/24/60)/Posm ml/min 2~3

CH2O Free water clearance V*(1‐uosm/posm) ml/h ‐120~-25

140
Operator’s Manual for Patient Monitor

U/Posm Ratio of Urine to Plasma Uosm / Posm —— 3.0~4.5


osmotic pressure

BUN/Scr Ratio of blood urea nitrogen to BUN / Scr —— ——


Serum Creatinine

U/SCr Ratio of Urine creatinine to Ucr / Scr —— ——


Serum Creatinine

Operations:
Entering the value for each input item, and click “Calculate”, and the monitor will calculate the parameter according to
the calculate formula, the result will be displayed on the screen. then click “Range” to view the range for each
parameter.

Notes:

1. The result for each parameter will be shown as “‐‐‐” before click “Calculate” button.

2. The calculate result will be shown in yellow if the result is beyond the reference range.

Result Unit

Renal function calculation‐‐‐Calculate result

141
Operator’s Manual for Patient Monitor

Range

Renal function calculation‐‐‐Reference range

18.7 HEMO.(Hemodynamic Calculation)


Select “Menu”→ “Hemo.” to enter into hemodynamic calculation window, as shown in below figure. Hemodynamic
calculation to derive CI, SV, SVR etc. based on the weight, height, HR etc..

 Hemodynamics Setting

Hemodynamics Setting

Parameters to be set for hemodynamics calculation:

142
Operator’s Manual for Patient Monitor

 C.O.: cardiac output.

 Height: patient's height.

 Weight: patient's weight.

 HR: heart rate.

 LVD: left ventricle diameter.

 MAP: mean artery pressure.

 MVP: mean vein pressure.

 PAW: pulmonary artery wedge pressure

 CVP: central vein pressure.

Description of hemodynamics calculation result and their formulas:

Result Description Formula Unit

CI Cardiac function Index C.O. / BSA liters/min/m2

SV Stroke Volume C.O. / HR*1000 ml

SVI Stroke Volume Index SV / BSA ml/m2

SVR Systemic Vascular Resistance 79.96 *(MAP ‐ CVP)/C.O. dynes·sec/cm‐5

SVRI Systemic Vascular Resistance Index SVR*BSA dynes·sec/cm‐5/m2

PVR Pulmonary Vascular Resistance 79.96 *(paMAP ‐ PAWP)/C.O. dynes·sec/cm‐5

PVRI Pulmonary Vascular Resistance Index PVR*BSA dynes·sec/cm‐5/m2

LCW Left Cardiac Work 0.0136*MAP*C.O. kg‐m

LCWI Left Cardiac Work Index LCW/BSA kg‐m/m2

LVSW Left Ventricle Stroke Work 0.0136*MAP*SV g·m

LVSWI Left Ventricle Stroke Work Index LVSW/BSA g·m/m2

RCW Right Cardiac Work 0.0136 * paMAP * C.O. kg‐m

RCWI Right Cardiac Work Index RCW/BSA kg‐m/m2

RVSW Right Ventricle Stroke Work 0.0136*paMAP*SV g·m

143
Operator’s Manual for Patient Monitor

RVSWI Right Ventricle Stroke Work Index RVSW/BSA g·m/m2

EF Ejection Fraction (SV/t)*100 m2

Note:BSA (Body Surface Area) = 0.006*height+0.0128*weight‐0.1529

t = ( 7.0 / ( 2.4 + lv_d/10 ) ) * lv_d * lv_d * lv_d / 1000 (lv_d:left ventricle diameter)

144
Operator’s Manual for Patient Monitor

Chapter 19 Tourniquet
Select “Menu” → “Tourniquet” to enter into Tourniquet window.

Tourniquet Settings Count‐down


 Pressure: the upper limit of the cuff pressure during inflation. The monitor will stop inflating if the cuff pressure
exceeds this value. The step is 10mmHg (1.3kPa) ranges and defaults for different patient age group are listed in
the table below:

Group Pressure range Default

Adult 80mmHg(10.7kPa)~180mmHg(24kPa) 140mmHg(8.7kPa)

Pediatric 80mmHg(10.7kPa)~130mmHg(17.3kPa) 110mmHg(14.7kPa)

Neonate 70mmHg(9.3kPa)~110mmHg(14.7kPa) 90mmHg(12kPa)


 Duration: the lasted time that cuff pressure maintained with the specified value. It is adjustable from 1 to 120
minutes with step of 1 minute. The default is "40" minutes.

 Deflation Count‐down: the initial value of the count‐down timer of cuff deflation. The minimum is 5, and the
maximum is the value specified by “Duration”. The default is 5 minutes. The cuff will deflate immediately when
the count‐down comes to zero.

 “Start/Stop” button: Start / stop tourniquet function. The cuff pressure value will be displayed during inflating.
Note: once enter into the window, then pressing "NIBP Measure key" can not perform NIBP measurement.

Notes:

1. If your monitor is configured with SunTech NIBP module, then the tourniquet cuff pressure range for adult is
120~180mmHg. The lasted time that cuff pressure maintained with the specified value for adult and pediatric is fixed
to be 170s and nonadjustable, and for neonate is fixed to be 85s and nonadjustable. The count‐down timer of cuff
deflation will not be displayed on the screen, and it begins to counting down once the cuff starts inflating.

2. The unit of cuff pressure is same as the unit of NIBP.

145
Operator’s Manual for Patient Monitor

Chapter 20 Printing
20.1 Using a Printer
The thermal Printer can be used to print patient information, measurement numerics, up to three waveforms, etc

Built‐in printer may be used due to the different configuration.

Printer operation instruction:


Power indicator: The green light shows the power is on. While the monitor is out of power, the green light is off.

Error indicator: red light is constant which shows the printer is out of paper, or the printing paper is not installed
properly. When the printing paper is loaded correctly, the red light is off.

Power Indicator

Open button
Error Indicator

Paper cartridge

20.2 Loading Printing Paper

This description is for loading paper for the built‐in printer.

Operating procedures:

1. Press both “OPEN” notches with force on printer shield with two thumbs to open it.
2. Move the tab of rubber roller lock at the left 90°upwards to unlock it.
3. Cut one end of the paper into triangle, and load the paper from the underside of the rubber roller.
4. Turn the roller clockwise to get the paper rolled, and put the paper roll into the compartment.
5. Pull the paper out of paper slot on the shield.
6. Move the tab of the rubber roller lock 90° downwards to lock it.
7. Put the shield back in position and secure it.

146
Operator’s Manual for Patient Monitor

Unloading printing paper


1. Press both “OPEN” notches vertically with force on printer shield with two fingers to open it.
2. Move the tab of roller lock at the left 90° upwards to unlock it.
3. Roll the loading roller anti‐clockwise and pull the paper out.
4. Roll the loading roller clockwise to get the paper rolled, and put it into the compartment.
5. Pull the paper out of paper slot on the shield.

Loading printing paper:


1: press and hold down the cartridge button to open the paper cartridge;

2: Install the paper to the printer properly, pull the paper out of the printer for 2 cm.

3: Close the printer cover along the direction of arrow.

Printing paper

20.3 Attentions
147
Operator’s Manual for Patient Monitor

 Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s print 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.

 Do not use anything that may destroy the thermal element.

 Do not add unnecessary force to the thermal head

20.4 Performing Printing


The device printing function consists of manual printing and auto trigger printing. The medical staffs can press the

Print key “ ”to perform printing, and the device can make cycle printing and auto trigger to print ARR event.

Start or stop printing by pressing Print Key “ ” located in the front panel.

The content for printing consists of real time data printing and review record printing. In different views and windows,
pressing Print key can print that shows in the following Tables.

20.4.1 Print Real Time Data

Contents
Current view/window
Header information Waveform/Text information

General view Data identifier: "==Real time=="; Print the real time waveform of 10
seconds:
Big font view Patient info.: PID, name, gender, patient group,
weight, height and birth date; The 1st trace: ECG waveform
All ECG view
Time: the current date and time when printing; The 2nd trace: ECG/SpO2/RESP
waveform
Real‐time parameter: speed, HR, SpO2, PR, RR,
TEMP1/2 and pressure value. The 3rd trace: nothing/RESP/SpO2
Short trends view waveform

Note: on the top of the printed


waveform area, the 10s waveform's
time will be shown within 2 interval.

Data identifier: "==NIBP List=="; Print the 11 groups of NIBP list


NIBP list view Item in the list: time, PID, name, SYS, DIA, MAP,
PR, HR and SpO2

Data identifier: "==RESP‐Oxy=="; Print the trend graph of RESP‐Oxy


RESP‐Oxy view
Patient info.: PID, name, gender, patient group,

148
Operator’s Manual for Patient Monitor

weight, height and birth date;

Time: the current date and time when printing;

The start time and end time of the RESP‐Oxy.

Data identifier: "==Real time=="; Print the real time waveform of 10


seconds:
Patient info.: PID, name, gender, patient group,
weight, height and birth date; The 1st trace: ECG waveform

Time: the current date and time when printing; The 2nd trace: ECG/SpO2/RESP
Menu, settings window waveform
Real‐time parameter: speed, HR, SpO2, PR, RR,
and functional window
TEMP1/2 and pressure value. The 3rd trace: nothing/RESP/SpO2
waveform

Note: on the top of the printed


waveform area, the 10s waveform's
time will be shown within 2 interval.

Data identifier: "==Real time=="; Print the real time waveform of 10


seconds:
Patient info.: PID, name, gender, patient group,
weight, height and birth date; The 1st trace: ECG waveform

Time: the current date and time when printing; The 2nd trace: ECG/SpO2/RESP
View's activating window waveform
Real‐time parameter: speed, HR, SpO2, PR, RR,
and settings window
TEMP1/2 and pressure value. The 3rd trace: nothing/RESP/SpO2
waveform

Note: on the top of the printed


waveform area, the 10s waveform's
time will be shown within 2 interval.

Data identifier: "==Real time=="; Print the real time waveform of 10


seconds:
Patient info.: PID, name, gender, patient group,
weight, height and birth date; The 1st trace: ECG waveform

Main screen of data Time: the current date and time when printing; The 2nd trace: ECG/SpO2/RESP
reviewing(before waveform
Real‐time parameter: speed, HR, SpO2, PR, RR,
entering each history
TEMP1/2 and pressure value. The 3rd trace: nothing/RESP/SpO2
records window)
waveform

Note: on the top of the printed


waveform area, the 10s waveform's
time will be shown within 2 interval.

Trigger real time printing Data identifier: "==ARR=="; Print the waveform of the current
when ARR event occurs ARR event
Patient info.: PID, name, gender, patient group,

149
Operator’s Manual for Patient Monitor

weight, height and birth date;

Time: the current date and time when printing;

Real‐time parameter: speed, HR, SpO2, PR, RR,


TEMP1/2 and pressure value.

20.4.2 Print History Records

Data review window Contents

Header information Waveform/text information

ARR event window Data identifier: "==ARR=="; Print the 6 items in ARR event list,
including time, ARR type, lead, gain,
Patient info.: PID, name, gender, patient group,
filter and HR.
weight, height and birth date;

Time: the current date and time when printing;

The operating status in Data identifier: "==ARR=="; Print the waveform of the current
ARR event, and setting reviewed ARR event.
Patient info.: PID, name, gender, patient group,
item "Print the current
weight, height and birth date;
record only" is selected.
Time: the current date and time when printing;

ARR info.: the time, ARR type, lead, gain, filter


and HR of the current reviewed ARR event.

The operating status in Data identifier: "==ECG Wave=="; Print the current reviewed ECG
ECG Wave waveform information.
Patient info.: PID, name, gender, patient group,
weight, height and birth date;

Time: the current date and time when printing;

ECG Wave information: ECG lead, speed, gain, HR,


filter, Start time and end time.

The operating status in Data identifier: "==Trend Graph=="; Print the trend graph of a certain
Trend Graph parameter displayed on the current
Patient info.: PID, name, gender, patient group,
window.
weight, height and birth date;

Time: the current date and time when printing;

Trend graph info.: parameter label, sampling


interval, start time and end time.

150
Operator’s Manual for Patient Monitor

The operating status in Data identifier: "==NIBP List=="; Print the 12 groups NIBP lists
NIBP List displayed on the current window.
Patient info.: PID, name, gender, patient group,
weight, height and birth date;

Time: the current date and time when printing;

Items in the list: time, SYS, DIA, MAP, PR, HR,


SpO2/HR and TEMP1......

The operating status in Data identifier: "==Alarm Event=="; Print the 11 groups alarm events
Alarm Event displayed on the current window.
Patient info.: PID, name, gender, patient group,
weight, height and birth date;

Time: the current date and time when printing;

Items in the list: time, event name, level,


parameter, alarm value, the preset high/low
alarm value.

The operating status in Data identifier: "==SpO2 Event=="; Print the 11 groups SpO2 events
SpO2 Event displayed on the current window.
Patient info.: PID, name, gender, patient group,
weight, height and birth date;

Time: the current date and time when printing;

Items in the list: time, PID, Minute‐average, SpO2,


PR, HR and RR.

20.5 Cleaning the Printing Head of Printer


If the printer has been used for a long time, deposits of paper debris may collect on the printing head compromising
the print quality and shortening the lifetime of the roller. Follow this procedure to clean the printing head:

1. Take measures against the static electricity such as Disposable Wrist Strap for the work.

2. Open the printer door and take out the paper.

3. Gently wipe around the printhead using cotton swabs dampened with Ethanol.

4. After the Ethanol has completely been dried, reload the paper and close the printer door.

151
Operator’s Manual for Patient Monitor

Chapter 21 Other Functions


21.1 System Information
Select “Menu” → “System Info”, then the "System Info" window can be entered, which including release version,
software version, hardware version and product ID.

Product ID: set by manufacturer for traceability.

For some monitors, it may also show embedded module information:

Embedded Module: other extended modules except the built‐in module (ECG/ SpO2/ NIBP/ RESP/TEMP), such as CSM
and CO2 module.

The current installed module information will also be displayed, for example, "Plug‐and‐Play modules L: CSM‐IoC R:
EtCO2".

21.2 Nurse Call Settings (Optional)


 Output level: the output level from nurse call connector, "High level" and "Low level" for option.

 Duration: two output modes for optional: "Continuous" and "Pulse". The continuous mode of output means the
nurse call signal will keep until the alarm disappears. The pulse mode means the output nurse call signal lasts for
one second.

 Trigger Condition: 3 kinds of alarm sources can trig the nurse call: high level alarm, medium level alarm and low
level alarm.

 Do not rely exclusively on the nurse call system for alarm notification. Remember that the most reliable alarm
notification combines audible and visual alarm indications with the patient’s clinical condition.

152
Operator’s Manual for Patient Monitor

Chapter 22 Battery
22.1 Overview
The monitor has built‐in chargeable battery, when the monitor is disconnected from the external AC power supply,
then it will be powered by the built‐in battery. When the monitor is supplied by external AC power, then the battery
will be charged. Generally, it's unnecessary to maintain the battery when using under normal working condition.

When the monitor is powered by built‐in battery, and battery is in low voltage, then technical alarm will be triggered,
and message "Low battery" pops up. At this moment, the user should connect the external power immediately to
make sure the monitor continue working.

On‐screen battery symbols indicate the battery status as follows:

AC Power supply and the battery is fully charged.

The red exclamatory mark blinks means battery voltage will be used out and needs to

charged. Alarm information area will show "Low Battery" message.

Charging status

/ / One / two/ full grid battery voltage left

The capacity of the internal battery is limited. If the battery voltage is too low, a technical alarm will be triggered and
the message displayed. At this moment, connect AC mains power to the monitor. Otherwise, the monitor will power
off automatically before the battery is completely depleted.

22.2 Battery Maintenance


 Please pay attention to the polarity of battery, do NOT insert it into battery compartment with reversed
polarities;

 Do NOT use the batteries manufactured by other companies, if being inserted, the device will may be
damaged;

 In order to avoid damaging the battery, do NOT use other power supply device to charge the battery;

 After battery ageing phenomenon occurs, do NOT throw the battery into fire to avoid explosion risk.

 Do not hit or strike it with force;

 Do not use this battery on other devices;

 Do not use this battery below ‐10°C or above 40°C;

 Dispose of the battery, the local law should be followed.

 In order to maintain battery supply time and prolong battery lifetime, please charge the battery every one or
two months if don’t use battery for a long time. Charge battery at least 12‐15 hours every time. Before
charging, run down the internal battery until the monitor turn off automatically to minimize memory effects.
Charging time will be the same no matter whether the monitor is working or not. Charge fully before putting
153
Operator’s Manual for Patient Monitor

the monitor into storage.

 Using a monitor powered solely by an internal battery which has short charge power will cause the monitor
turn off automatically when the battery is depleted.

 Do not use batteries manufactured by other companies, which may cause damage to the device. If battery is
damaged, please replace with same type and specification battery marked by “CCC” or “CE” in time, or contact
the company directly.

Warning:
1. To avoid battery damage always remove battery(s) before shipping or storage.
2. It is recommend to use the battery specified by the manufacturer.

3. Life expectancy of a battery depends on how frequently and how long it is used. For a properly
maintained and stored lead‐acid or lithium battery, its life expectancy is about 2 or 3 years
respectively. For more aggressive use mode, life expectancy can be less. We recommend replacing
lead acid battery every 2 years and lithium battery every 3 years.

Caution:

 Keep the battery out of the reach of children.

 Do not disassemble battery.

22.3 Battery Recycling


When a battery has visual signs of damage, or no longer holds a charge, it should be replaced. Remove the old battery
from the monitor and recycle it properly. To dispose of the batteries, follow local laws for proper disposal.

154
Operator’s Manual for Patient Monitor

Chapter 23 Cleaning and Disinfection


23.1 Cleaning the Device and Accessories
Your device should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place, the
device should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations for
cleaning the device.

Recommended cleaning agents are:

 Sodium hypochlorite bleach (diluted)

 Hydrogen peroxide (3%)

 75% Ethanol

 70% Isopropanol

To clean your device, follow these rules:

 Switch off the monitor and disconnect the power cable before cleaning.

 Kept the monitor from dust.

 It is recommended to clean the outer shell and screen of the monitor to keep it clean. Only non‐corrosive
cleanser such as clear water is permitted.

 Wipe the surface of the monitor and transducers with an Ethanol impregnated wipe, and dry it with dry and
clean wipe or simply air‐dry.

 This monitor can be disinfected, please clean the monitor firstly.

 Do not let the liquid cleanser flow into the connector jack of the monitor to avoid damage.
 Clean the exterior of the connector only.

 Dilute the cleanser.

 Do not use abrasive materials.

 Do not let any liquid flow into the shell or any parts of the monitor.

 Do not let the cleanser and disinfectant stay on its surface.

 Do not perform high pressure sterilization to the monitor.

 Do not put any parts of the monitor or its accessories in the liquid.

 Do not pour the disinfectant on its surface while disinfectant.

 If the monitor is accidentally wet, it should be thoroughly dried before use. The rear cover can be removed
by qualified service technician to verify absence of water.

 Never use this machine in an environment with inflammable gas.

 Avoid being hit by lightning. The power cable should be plugged into an outlet with grounding wire. Do not
use an outlet with poor condition. If possible, use power supply system with regulator.

155
Operator’s Manual for Patient Monitor

 It must be used in a clean environment protected against shock. Keep it away from corrosive substances,
explosive substances, high temperature and dampness.

 If it is installed in a cabinet, make sure the installation allows for good ventilation, and easy maintenance,
observation and operation.

23.2 Disinfecting the Device and Accessories


Disinfection may cause damage to the device and is therefore not recommended for this monitor unless otherwise
indicated in your hospital's servicing schedule. Cleaning device before disinfecting is recommended.
The recommended disinfects include:
 75% Ethanol
 70% Isopropanol
 Do not use damaged accessories.

 Accessories cannot be entirely immerged into water, liquor or cleanser.

 Do not use radiation, steam or EO to disinfect accessories.

 Do wipe off the remained Ethanol or isopropanol on the accessories after disinfection, for good maintenance
can extend the life of accessories.

 Single‐use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the
measurement accuracy.

156
Operator’s Manual for Patient Monitor

Chapter 24 Maintenance
In case of trouble of this machine in the service, follow the instructions below to eliminate the problem first. If the
attempt fails, refer to the dealer in your local area or the manufacturer. Refer to the detailed provisions in contract for
the warranty period of the main unit and the accessories of this monitor.

24.1 Daily Examination


Before using the monitor, the checks below should be carried out:

 Check the monitor for any mechanical damage;


 Inspect the exposed parts and the inserted parts of all the cables and the accessories;
 Examine all the functions of the monitor that are likely to be used for patient monitoring, and ensure that it
is in good working condition;
 Make sure that the monitor is grounded properly.
 Pay close attention to the fluctuation of the local power supply voltage. A power voltage regulator is
recommended when necessary.
In case any indication of damage about the function of the monitor is detected and proven, it is not allowed to apply it
to the patient for any monitoring. Please contact the local dealer or our company, and we are to offer the best
solution as soon as possible for your satisfaction.

24.2 Routine Maintenance


At each routinely maintenance or the yearly maintenance, the monitor can be thoroughly inspected by qualified
personnel, including performance and safety examinations. This monitor is designed with life cycle of 5 years. It is
strongly recommended to use the product which is still within its life cycle, or it may cause inaccurate measurement.
In order to ensure its long service life, please pay attention to the maintenance.

 If the hospital fails to carry out a satisfactory maintenance program about the monitor, it may get disabled and
harm the patient’s safety and health.

 Perform protective grounding impedance, leakage current and insulation resistance test.

 In case of ECG cable/lead wires damage or aging, please replace the cable or lead wires.

 If there is any indication of cable and transducer damage or they deteriorate, they are prohibited from any
further use.

 The Monitor is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle. Any
patient simulators should not be used to validate the accuracy of blood pressure and oxygen saturation
measurement, they can only be used as functional testers to verify its precision.

 The accuracy of ECG signal amplification can be verified by the built‐in 1mV calibration signal.

 The accuracy of pressure measurement and air leakage in pneumatic system can be verified by means of the
built‐in pressure verification function and a precision pressure meter, please refer to the related chapter in Part
2 of the user manual for detail operation.

 The SpO2 simulator cannot be used to verify the SpO2 measuring accuracy, which should be supported by the

157
Operator’s Manual for Patient Monitor

clinical study conducted by inducing hypoxia on healthy, non‐smoking, light‐to‐dark‐skinned subjects in an


independent research laboratory. However it is necessary for the user to use SpO2 simulator for routine
verification of precision.

 Please note that the specific calibration curve (so called R‐curve) should be selected when use of SpO2
simulator, e.g. for Index 2 series SpO2 simulator from Fluke Biomedical Corporation, please set "Make" to
"DownLoadMake: KRK", then the user can use this particular R‐curve to test the SpO2 function of the patient
monitor with Creative oximetry technology. If the SpO2 simulator does not contain the specific R‐curve, please
ask the manufacturer for helping to download the given R‐curve into the SpO2 simulator.

 The adjustable units within the monitor such as potentiometers are not allowed to adjust without permission
to avoid unnecessary failures that affect normal application.

 It is recommended to use the battery once a month to ensure its power capability and long service life, and
recharge it after run out of its power capacity.

24.3 ECG Verification


The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude
becomes greater or smaller.

You can print out the square wave and wave scale and then measure the difference between them if necessary. If the
difference exceeds 5%, contact your service personnel.

24.4 Pressure Accuracy Verification


Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP module
inside the device. Technician or equipment manager should do pressure accuracy verification every half year or year in
order to check if the pressure measurement still conforms to the requirement of product performance. If the
deviation is beyond the declared specification, it is permitted to return it to factory for repair or calibration.

Before verification, please connect the monitor to a precision pressure meter as the reference equipment like a
mercury pressure meter

158
Operator’s Manual for Patient Monitor

Mercury blood
pressure meter

NIBP cuff with dual air tube

Air tube

Air tube

Air tube

Air tube Air vent

Manual valve Increase the pressure manually


Module testing NIBP through the inflatable balloon
software module Inflation balloon

This belongs to the monitor

Mode 1: Automatic inflation for the pressure accuracy verification

At this mode, the monitor can activate the inflation, so the pressure will increase automatically until it exceeds the
limit value specified in table A. This pressure limit value depends on the patient type selection as shown in table A:

Adult 240mmHg

Pediatric 200mmHg

Neonate 120mmHg

Table A

During the inflation, the Monitor will close the deflating valve, and the pressure value will be shown during the
process. If there is no manual deflation operation, the pressure will persist until deflation by manual operation, so it is
necessary to use a manual valve for doing adequate deflation in several steps to verify the pressure accuracy in the full
scale of measurement range.

Mode 2: Manual inflation for the pressure accuracy verification.

At this mode, the pressure should be increased manually by a pumping balloon, and the verification can be done by
applying different pressure value manually. If the increased pressure exceeds the given limit as shown in table B, the
Monitor will deflate automatically because of over‐pressure protection.

Adult 300mmHg

159
Operator’s Manual for Patient Monitor

Pediatric 240mmHg

Neonate 140mmHg

Table B

 After the verification, do press the button again to return to normal working mode, then continue other
operation, or the NIBP key will be invalid.

 Pressure accuracy verification must be operated by technician or equipment manager. Doctors and nurses
are not allowed to do the verification, it is very dangerous especially when the pressure cuff is still on
patients.

 Air Leakage Check


In order to avoid significant error of blood pressure measurement or even no measurement result caused by air
leakage in the pneumatic system including the cuff during measuring, it is recommended to check if there is leak in the
pneumatic system as well.

Please remove the cuff from patient while performing the leakage check.

24.4 IBP Calibration (Optional)


This section is for professional technician only.

Each time connecting transducer or selecting another measuring label, then prompt displays on the screen. There is
two methods for calibration: zero calibration and pressure value calibration.

Calibration procedure:

1. On calibration window, press "Zero" button to perform zero calibration, then "Zeroing OK" will display on the
window.

The following message may may appear on the window during calibration:

 Probe off, unable to zero

 Probe off, unable to calibrate

 Unstable zero base pressure

 Pressure out of range

 Zeroing OK

2. Expulse all the air from the tube, then adjust the transfusion tube and stopcock (“Off” to the transfusion tube).
Open the dust cap, and ensure the dome touch the air.

3. Zero calibration is required, zero calibration must be done before IBP monitoring, or the IBP readings will not be
accurate.

4. It is recommended that “0 calibration” must be carried out each time before measuring, and at least performing
once a day (zero calibration should be performed every time you connecting the plug to the IBP socket on the
monitor), or the inaccuracy will be caused. If using a new IBP transducer, please perform pressure calibration.

160
Operator’s Manual for Patient Monitor

24.5 CO2 Test


For sidestream CO2 modules, a calibration is needed every year or when the measured values have a great deviation.
For maintream CO2 module, no calibration is needed. Contact your service personnel to calibrate CO2.

24.6 Calibrating AG
Calibrate the AG module every year or when the measured value has a great deviation. Contact your service personnel
to calibrate the AG module.

161
Operator’s Manual for Patient Monitor

25 Accessories
 Check the accessories and their package for any signs of damage. Do not use them if any damage is detected.

Part Name Remark

ECG cable

ECG electrode

Adult SpO2 Finger clip Sensor Optional


SpO2 Sensor
Pediatric SpO2 Finger clip Sensor Optional

SpO2 sensor cable extender Optional

Adult NIBP cuff Optional

Small‐sized Pediatric NIBP Cuff Optional


Cuff
Middle‐sized Pediatric NIBP Cuff Optional

Large‐sized Pediatric NIBP Optional

Body TEMP probe


TEMP probe
Infrared temperature probe Optional

CO2 Mainstream sensor Optional for mainstream

Airway Adult airway adapter Optional for mainstream

adapter Pediatric airway adapter Optional for mainstream

CO2 Sidestream sensor Optional for sidestream

Sampling line kit Optional for sidestream

Extending airway tube Optional for sidestream

Wye connector Optional for sidestream

Power cord

Net wire

Printing paper Optional


For more information regarding the accessories, please contact your local sales representative or the manufacturer.

Note: Part No. is subject to change without prior notice, please refer to the label of parts or package list.

162
Operator’s Manual for Patient Monitor

26 Technical Specifications
26.1 ECG
1. Input dynamic range: ±(0.5mVp ~ 5mVp)
2. Heart rate display range: 15 bpm ~ 350 bpm ( for Adult and Pediatric)
3. Heart rate display accuracy: ±1% or ±2bpm, whichever is greater.
4. Heart rate averaging: Averages the recent eight beats having RR intervals falling within the acceptable limits.
5. Defibrillation recovery time: ≤10 sec
6. Alarm signal (for any alarm source) generation delay time: <1 sec
Heart rate alarm condition delay time: ≤10 sec
7. Response time to change in heart rate:
Change from 80bpm to 120bpm: <8 sec
Change from 80bpm to 40bpm: <8 sec
8. Tall T‐wave rejection: Rejects all T‐wave less than or equal to 120% of 1mV QRS.
9. Pacemaker pulse rejection:
Rejects all pulses of amplitude ±2mV to ±700mV and duration 0.1 to 2 ms without overshoot;
10. Sensitivity selection: ×1/4, ×1/2, ×1, ×2, ×4 and AUTO
×1/2, 5mm/mV tolerance: ±5%
×1, 10mm/mV tolerance: ±5%
×2, 20mm/mv tolerance: ±5%
11. Sweeping speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s tolerance: ±10%
12. ECG noise level: ≤30μVP‐P.
13. ECG input loop current: ≤0.1μA
14. Differential input impedance: ≥10MΩ
15. Common‐mode rejection ratio (CMRR):
In Diagnostic mode: ≥90dB In Operation and Monitoring mode: ≥105dB
16. Time constant:
Monitoring mode: ≥0.3s Diagnostic mode: ≥3.2s
17. Frequency response:

Operation mode: 1 Hz~20Hz(+0.4dB


-3.0dB)

Monitoring mode: 0.67 Hz~40Hz(+0.4dB


-3.0dB)

Diagnostic mode: 0.05 Hz~150Hz(+0.4dB


-3.0dB)

26.2 RESP

163
Operator’s Manual for Patient Monitor

1. RESP rate measuring range: 0rpm~120rpm


2. RESP rate accuracy: ±5% or ±2 rpm, whichever is greater
3. RESP rate alarm limit setting range: High: 1rpm~150rpm; Low: 0rpm~149rpm.
4. Alarm tolerance: ±1rpm

26.3 TEMP
1. TEMP measuring range: 21.0℃~50.0 ℃
2. TEMP measuring accuracy: ±0.2 ℃ for the range from 25℃ to 45℃, 0.4 ℃ for other ranges.
3. TEMP responding time: ≤150s
4. TEMP minimum measuring time: ≥130s
5. Measuring site: body surface
6. Mode of operation: direct mode
7. Unit: ℃ and °F
8. TEMP alarm limit setting range: High: 0℃~60℃; Low: 0℃~59.9℃.
9. Tolerance: ±0.1℃

26.4 NIBP
1. Measuring method: Oscillometric Technique
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg
3. Accuracy of pressure measurement: ±3 mmHg
4. Typical measurement time: <30 seconds (adult cuff)
5. Measurement time on the average: < 90 seconds
6. Air release time while the measurement is canceled: <2 seconds (typical adult cuff)
7. Initial cuff inflation pressure
Adult: <150 mmHg; Pediatric: <120 mmHg; Neonate: <70 mmHg Tolerance: ±5 mmHg
8. Overpressure protection limit
Adult: 300 mmHg; Pediatric: 240mmHg; Neonate: 150 mmHg
9. NIBP measurement range:

Pressure(unit) Adult Pediatric Neonate

mmHg 40~275 40~200 40~135


SYS
kPa 5.3~36.7 5.3~26.7 5.3~18.0

mmHg 20~230 20~165 20~110


MAP
kPa 2.7~30 2.7~22.0 2.7~14.6

mmHg 10~210 10~150 10~95


DIA
kPa 1.3~28 1.3~20.0 1.3~12.7

164
Operator’s Manual for Patient Monitor

10. NIBP accuracy:


Maximum mean difference: ±5 mmHg
Maximum Standard deviation: 8 mmHg
11. Measurement mode: Manual, Auto, STAT, Customized Multi‐cycle
12. NIBP Alarm setting range: see Section Alarms

26.5 SpO2
1. Transducer: dual‐wavelength LED
Wavelength: Red light: 663 nm, Infrared light: 890 nm.
(Note: for Series III and Series IV, Red light: 660 nm, Infrared light: 905 nm)
Maximal optical output power: less than 2mW maximum average
2. SpO2 measuring range: 0%~100%
3. SpO2 measuring accuracy: Arms* is not greater than 2% for SpO2 range from 70% to 100%
*NOTE: Arms is the accuracy defined as root‐mean‐square value of deviation according to ISO 80601‐2‐61.
4. Alarm range: High: 1%~100%; Low: 0%~99%
5. Low perfusion performance: the declared accuracy is sustained when the pulse amplitude modulation ratio is
as low as 0.3%
Data averaging and update:

The displayed SpO2 and Pulse Rate values are the average of data collected within a specific time. The SpO2 is
calculated every second by the data collected in recent 5 seconds, the Pulse Rate is calculated for every beat. The
averaging method depends on the pulse rate value, for pulse rates below 50bpm, the SpO2 is averaged by 16‐second
sliding average, the Pulse Rate is averaged by 4‐beat sliding average; for pulse rates between 50bpm and 120bpm, the
SpO2 is averaged by 8‐second sliding average, the Pulse Rate is averaged by 8‐beat sliding average; for pulse rates
above 120bpm, the SpO2 is averaged by 4‐second sliding average, the Pulse Rate is averaged by 16‐beat sliding
average.

The screen display of SpO2 and Pulse Rate are updated every second with the most recent value, if the signal is noisy
or missing, the display will hold the last value for at most 15 seconds before showing dashes.

The over‐limit alarm is triggered once the SpO2 or Pulse Rate exceeds the preset limits, the alarm signal generation
delay is small (less than 1 second) compared with the alarm condition delay, which is caused by the data average as
described above.

26.6 Pulse Rate


1. Pulse rate measuring range: 0bpm~250bpm
2. Pulse rate measurement accuracy: ±2bpm or ±2%, whichever is greater.
3. Alarm range: High:(1~300)bpm; Low:(0~299)bpm
4. Pulse rate alarm tolerance: ±2bpm within (30~250) bpm
Note: The pulse rate ACCURACY is tested by an electronic pulse simulator.

165
Operator’s Manual for Patient Monitor

26.7 CO2
1. Technology: Infrared absorption method.
2. Mode of Sampling: Sidestream or Mainstream
3. CO2 Response Time:
Sidestream: <3seconds (including transport time and rise time).
Mainstream: <60ms (rise time)
4. Warm‐up Time: Not less than two minutes
5. CO2 measurement range: 0~150mmHg
6. CO2 Accuracy: 0~40mmHg ±2mmHg
41~70mmHg ±5% of reading
71~100mmHg ±8% of reading
101~150mmHg ±10% of reading
7. Alarm range: high limit: 0.1mmHg ~150mmHg
Low limit: 0mmHg ~149.9mmHg
*NOTE: Gas temperature at 25°C for Sidestream;
Gas temperature at 35°C for Mainstream
7. Flow rate: 50ml/min ±10 ml/min (Sidestream)

26.8 CSM
1. EEG sensitivity: ±400μV

2. Noise level: <2μVp‐p, <0.4μV RMS, 1~250Hz

3. CMRR: >140dB

4. Input impedance>50 Mohm

5. Sample rate: 2000 samples/sec. (14 bits equivalent)

6. CSI and update: 0‐100. Filter 6‐42 Hz, 1sec. update

7. EMG: 0‐100 logarithmic. Filter 75‐85 Hz, 1 sec. update

8. BS%: 0‐100%. Filter 2‐42 Hz, 1sec. update

9. Digital output (for external CSM unit): Wireless to R232 link (ISM 2.4 GHz)

10. Wireless range: Up to 10 meters

26.9 IBP
1. Measuring method: Strain gauge transducer
2. Input Sensitivity:5μV/V/ mmHg tolerance: ±10%
3. Pressure measurement range: ‐50mmHg~300mmHg

166
Operator’s Manual for Patient Monitor

4. Measurement accuracy: ±2% or ±4mmHg, whichever is greater.


5. Measuring positions:

ART arterial pressure RAP right atrium pressure

PA pulmonary artery pressure LAP left atrium pressure

CVP central venous pressure ICP intracranial pressure

AUXP1 Auxiliary pressure 1 AUXP2 Auxiliary pressure 2

6. Sampling rate: 512Hz


7. Calibration method: zero calibration or 100mmHg(optional)

8. IBP alarm tolerance: ±1mmHg(±0.1kPa).


9. IBP Transducer volume output: mm3/100mmHg.
10. Default value: see Section Alarms

26.10 Cardiac Output (C.O.)


1. BT

Range: 23‐43℃, Tolerance: ±0.5℃

2. IT

Range: 0‐20 ℃, Tolerance: ±0.5℃

3. C.O.

Range: 0.2~20 L/min, Tolerance:±0.2 L/min or ±10% (whichever is greater)

26.11 Anaesthesia Gas (AG)

Measuring Range and Accuracy

The following accuracy specifications are valid for dry single gases at 22±5 ℃ and 1013±40 hPa:

(1) IRMA mainstream analyzer

Gas Measuring Range Accuracy

±(0.2 + 2% of reading) vol%, for the range from 0 to 10 vol%


CO2 0~15 vol%
±(0.3 + 2% of reading) vol%, for the range from 10 to 15 vol %

N2O 0~100 vol% ±(0.2 + 2% of reading) vol%

±(0.1 + 5% of reading) vol%


HAL, ISO, ENF 0~8 vol%
Unspecified

±(0.15 + 5% of reading) vol%


SEV 0~10 vol%
Unspecified

167
Operator’s Manual for Patient Monitor

DES 0~22 vol% ±(1 + 2% of reading) vol%

(2) ISA sidestream analyzer (ISA CO2, ISA AX+, ISA OR+)

Gas Range Accuracy

CO2 0~15 vol% ±(0.2 + 2% of reading) vol%

N2O 0~100 vol% ±(0.2 + 2% of reading) vol%

HAL, ISO, ENF 0~8 vol% ±(0.15 + 5% of reading) vol%

SEV 0~10 vol% ±(0.15 + 5% of reading) vol%

DES 0~22 vol% ±(1 +2% of reading) vol%

Agent Threshold

IRMA

Primary agent threshold 0.15 vol%

Secondary agent threshold 0.2 vol + 10% of total agent concentration

ISA (ISA OR+ / ISA AX+)

Primary agent threshold 0.15 vol%

Secondary agent threshold 0.2 vol + 10% of total agent concentration

System Response Time

1) Warm‐up time

ISA CO2: < 10 seconds

ISA OR+/AX+: < 20 seconds

2) Rise time at 50 sml/min sample flow

ISA CO2

CO2 <=200ms

ISA OR+/AR+

CO2 <=300ms

N2O, O2, DES, ENF, ISO, SEV <=400ms

HAL <=500ms

3) Total system response time

168
Operator’s Manual for Patient Monitor

ISA CO2 < 3 seconds

ISA OR+/AX+ < 4 seconds (with 2m Nomoline Airway Adapter Set sampling line)

MAC Formula

MAC = %et (AA1)/(AA1)+%ET(AA2)/(AA2)+%et (N2O)/100

X(AA): HAL = 0.75%, ENF = 1.7%, ISO = 1.15%, SEV = 2.05%, DES = 6.0%

End of Tide (ET) Value

ET will typically decrease below nominal value (ETnom) when respiration rate (RR) exceeds the RR threshold (RRth)
according to the following formulas:

CO2 (ISA CO2) ET= ETnom×(125/RR) for RRth>125

CO2 (ISA OR+/AR+) ET= ETnom× (70 / RR ) for RRth>70

N2O, O2, DES, ENF, ISO, SEV ET= ETnom× (50 / RR ) for RRth>50

HAL ET= ETnom× (35 / RR ) for RRth>35

Interfering Gas and Vapor Effects

(1) IRMA interfering gas and vapor effects

Gas or vapor Gas level CO2 Aesthetics N2O

N2O ④ 60 vol% ①&② ①&② ① ①

HAL④ 4 vol% ① ① ① ①

ENF, ISO, SEV④ 5 vol% +8%of the reading  ① ① ①

DES④ 15 vol% +12% of the reading ① ① ①

XE(Xenon)④ 80 vol% ‐10%of the reading ① ①

HE(Helium)④ 50 vol% ‐6%of the reading ① ①

Metered dose inhaler


Not for use with metered dose inhaler propellants
propellants④

C2H5OH(Ethanol)④ 0.3 vol% ① ① ① ①

C3H7OH(Isopropanol)④ 0.5 vol% ① ① ① ①

CH3COCH3(Acetone)④ 1 vol% ① ① ① ①

CH4(Methane)④ 3 vol% ① ① ① ①

CO(Carbon monoxide)⑤ 1 vol% ① ① ① ①

169
Operator’s Manual for Patient Monitor

NO(Nitrogen monoxide)⑤ 0.0250 vol% ① ① ① ①

O2 100vol% ①&② ①&② ① ①

Note ①: Negligible interference, effect included in the specification "Accuracy, all conditions" above.

Note ②: for probes not measuring N2O and/or O2 the concentrations shall be set from host. (IRMA CO2) measures
neither N2O nor O2 , IRMA AX+does not measure O2.

Note : Interference at indicated gas level. For example, 50 vol% Helium typical decreases Vol%
CO2readings by 6%. This means that if measuring on a mixture containing 5.0vol% CO2and 50 vol5
Helium, the measured CO2 concentration will typically be (1‐0.06)*5.0 vol%=4.7vol%CO2.
Note ④: according to the EN ISO 21647:2004 standard.

Note ⑤: in addition to the EN ISO 21647:2004 standard.

(2) ISA interfering gas and vapor effects

Gas or vapour Gas level CO2 Aesthetics N2O

N2O ④ 60 vol% ISA CO2. ISZZX+ ① ①

HAL④ 4 vol% ② ① ① ①

+8%of the
ENF, ISO, SEV④ 5 vol% ① ① ①
reading 

+12%of the
DES④ 15 vol% ① ① ①
reading

XE(Xenon)④ 80 vol% ‐10%of the reading ① ①

HE(Helium)④ 50 vol% ‐6%of the reading ① ①

Metered dose inhaler


Not for use with metered dose inhaler propellants
propellants④

C2H5OH(Ethanol)④ 0.3 vol% ① ① ① ①

C3H7OH(Isopropanol)④ 0.5 vol% ① ① ① ①

CH3COCH3(Acetone)④ 1 vol% ① ① ① ①

CH4(Methane)④ 3 vol% ① ① ① ①

CO(Carbon monoxide)⑤ 1 vol% ① ① ① ①

NO(Nitrogen monoxide)⑤ 0.0250 vol% ① ① ① ①

O2 100vol% ② ② ① ①

Default Alarming Values and Setting Range

170
Operator’s Manual for Patient Monitor

Mode Default value Setting range

Parameter (for all patient type ) (for all patient type)

High limit 6.6% (Low limit +0.1)~15%


EtCO2
Low limit 3.3% 0~(High limit ‐ 0.1)%

High limit 0.5% (Low limit +0.1)~15%


FiCO2
Low limit 0% 0~(High limit ‐ 0.1)%

High limit 55 (Low limit +1)~100


EtN2O
Low limit 0 0~(High limit ‐ 1)

High limit 53 (Low limit +1)~100


FiN2O
Low limit 0 0~(High limit ‐ 1)

High limit 3.0%


EtAA1 EtHal/Enf/Iso High limit setting range:
Low limit 0%
(Low limit +0.1)~15%
High limit 6.0%
EtSev
Low limit 0%
EtAA2 Low limit setting range:
High limit 8.0%
EtDes 0~(High limit ‐ 0.1)%
Low limit 0%

High limit 2.0%


EtHal/Enf/Iso High limit setting range:
FiAA1 Low limit 0%
(Low limit +0.1)~15%
EtSev High limit 5.0%

FiAA2 Low limit 0%


Low limit setting range:
EtDes High limit 6.0%
0~(High limit ‐ 0.1)%
Low limit 0%

171
Operator’s Manual for Patient Monitor

Electromagnetic Immunity

The IRMA probe is intended for use in the electromagnetic environment specified below. The customer or the user of
the IRMA probe should assure that it is used in such an environment.

Compliance
Immunity test IEC 61001 test level Electromagnetic environment‐ guidance
level

Electrostatic ±6 kV Floor should be wood, concrete or ceramic tile. If


±6 kV contract
discharge (ESD) contract floors are covered with synthetic material, the
±6 kV air relative humidity should be at least 30%.
IEC 61000‐4‐2 ±6 kV air

Power frequency

(50/60Hz) magnetic Mains power quality should be that of a typical


3A/m 3A/m
field commercial or hospital environment.

IEC 61000‐4‐8

Mains power quality should be that of a typical


commercial or hospital environment. If the use of the
RF emissions IRMA probe requires continued operation during
N/A Group 1
GISPR 11 power mains interruptions, it is recommended that
the IRMA probe is powered from an uniterruptible
power supply or a battery

The IRMA probe uses RF energy only for its internal


RF emissions function. Therefore, its RF emissions are very low and
N/A Group B
GISPR 11 are not likely to cause any interference in nearby
electronic equipment.

Conducted RF 3 Vrms Portable and mobile RF communications equipment


10 Vrms should be used no closer to any part of ISA
IEC 61000‐4‐6 150 kHz ‐ 180 MHz
sidestream analyzer, including cables, than the

172
Operator’s Manual for Patient Monitor

recommended separation distance calculated from


the equation applicable to the frequency of the
transmitter.

Recommended separation distance

d=0.35 P

d=0.18 P 80MHz to 800MHz

d=0.35 P 800MHz to 2.5GHz

Where P is the maximum output power rating of the


Radiated RF 3 V/m
20 V/m transmitter in watts (W) according to the transmitter
IEC 61000‐4‐3 180 MHz ‐ 2.5 GHz manufacturer and d is the recommended separation
distance in metres (m). b

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.

26.12 S‐T Segment


1. Measuring range: ‐2.0mV~+2.0mV
2. Tolerance: ‐0.8mV~+0.8mV ±0.02mV or ±10% (which is greater)

26.13 Data Recording


1. Sensitivity selection tolerance: ±5%
2. Recording speed: 25mm/s
3. Recording speed accuracy: ±10%
4. Hysteresis: ≤0.5mm
5. Frequency response:
Monitoring mode: 0.5~40Hz Diagnostic mode: 0.05~75Hz
6. Time constant:
Monitoring mode: ≥0.3s Diagnostic mode: ≥3.2s

26.14 Other Technical Specifications


1. Power supply: AC100V‐240V, 50/60Hz, 60VA; Internal power supply: DC 11.1V

173
Operator’s Manual for Patient Monitor

2. Mode of operation: Continuous


3. Applied Part: ECG lead wire, SpO2 sensor, TEMP sensor, Cuff and CO2 module
4. Display mode: TFT color LCD
5. Alarm mode: audible & visible alarm
6. Communication: Net port

26.15 Classification

Safety standard: IEC 60601‐1

The type of protection against electric shock Class I and Internally powered equipment

Defibrillation‐proof BF and Defibrillation‐proof CF


The degree of protection against electric shock
applied parts

Electro‐Magnetic Compatibility Group I, Class A

The protection against harmful ingress of liquid IPX2


or particulate matter
The device is not intended for use in an oxygen rich environment.
The surface of the device can be cleaned and disinfected with 75% Ethanol, no need to sterilize.

26.16 Operating Environment


1. Ambient temperature range: 5°C~40°C

Relative humidity: 15%~85%, non‐condensing

Atmospheric pressure: 70kPa ~106.0kPa

Power Voltage: (100‐240)VAC

Power frequency: 50Hz/60Hz

2. This equipment should be situated in a place protected against direct sunlight, so as to prevent overheating inside
the equipment.

3. The device should be stored and used within specified temperature, humidity and atmospheric pressure range, or it
may cause damage to the device or inaccurate measurement result.

4. If the device gets wet by accident, the operator should NOT power it on directly until it has been air‐dry enough to
avoid any damage to it.

5. Do not use this equipment in an environment with toxic or inflammable gas.

6. This equipment should be placed on a stand or flat platforms, so as to prevent possible shock.

7. Do not use this equipment in combination with any equipment other than those expressly permitted in the manual.

8. The monitor is defibrillator discharge proof and can be used with electrosurgical unit. But when the device is used
together with defibrillator or electrosurgical equipment, the user (doctor or nurse) should keep the patient under
close surveillance for his/her safety. Refer to the following function description for specific protective measures or

174
Operator’s Manual for Patient Monitor

notes.

9. Make sure that the equipotential grounding terminal is grounded correctly.

10. Do not use mobile phone nearby, so as to avoid strong radiant field interference.

26.17 Storage
If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging, which shall be
kept in a dry and good ventilation place free from dust and corrosive gases

Storage environment: ambient temperature: ‐20~60°C


relative humidity: 10%~95%
atmospheric pressure: 53kPa~106kPa

26.18 Transportation
This monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms. Do not
hit or drop it with force.

Transportation environment: ambient temperature: ‐20~60°C

relative humidity: 10%~95%

atmospheric pressure: 53kPa~106kPa

26.19 Packaging
The product is packed in high quality corrugated cartons with foam inside to protect the apparatus against damage in
the handling process.

Gross weight: Details see the indication on the outer package

Dimension: Details see the indication on the outer package

175
Operator’s Manual for Patient Monitor

Chapter 27 Troubleshooting
Note:

In case of trouble of this machine in service, follow the instructions below to eliminate the problem first. If the
attempt fails, contact the dealer in your local area or the manufacturer.

 Do NOT open the monitor cabinet without permission

 During operation, if the system error and the prompt pops up on the screen, then the system will
shutdown, and it restarts within 5 seconds and resume to factory default settings.

27.1 No Display on the Screen

Shut down the machine and unplug the power cable. Use a universal meter to check if the outlet has proper voltage,
check the power cable is in good condition, and that it has been properly connected to the monitor and outlet.
Remove the fuse from the back cover of this machine, and make sure it is in good condition. If all of above is in good
condition, there may be an issue with display screen.

27.2 Excessive ECG Signal Interference or too Thick Baseline


1. Check if the plate electrodes are properly located, and if valid plate electrodes are used.

2. Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires are
broken.

3. Make sure the mains outlet has standard grounding wire.

4. Check if the grounding wire of the apparatus properly grounded.

27.3 No Blood Pressure and Pulse Oxygen Measures


1. Check if the blood pressure cuff is properly wrapped around the arm according to the operating instructions, if the
cuff leaks, and if the inlet is closely connected with the NIBP jack on the side panel. Check if the indicator of the
pulse oxygen sensor flashes and if the pulse oxygen probe is properly connected to the SpO2 jack on the side
panel.

2. If the problems still exist, please contact the manufacturer.

27.4 Troubleshooting of CSM


 CSM does not turn on when power key is pressed?
Change to a new battery or fully recharged battery.

If changing the battery does not help, send the CSM for service.

 Blanked index‐ why?

176
Operator’s Manual for Patient Monitor

Sensor impedance too high

If sensor impedance is >5kΩ the CSI, BS AND EMG will be blanked.

Check that sensors are not dry.

Check that the skin has been cleaned properly.

Clean skin as described in chapter 3 and attach new sensors.

 CSI rises along with EMG

High levels of facial muscular or electromyographic (EMG) activity can elevate the CSI under certain circumstances.
When this happens, attention must be paid to the stimuli received by the patient during surgery. When the
patient is asleep, EMG activity can increase due to reflex reactions to painful stimuli during surgery, lack of
muscular relaxation or muscular rigidity caused by some opioids (analgesics). In the presence of hypnotically
unrelated EMG, administration of a neuromuscular blocking agent may cause the CSI to decrease.

Note:

Facial muscles will recover sooner than skeletal muscles.

When these artifacts are present, the CSI should be interpreted with caution.

27.5 No CO2 Readings

Status/ error Status type Description Correction action

The temperature of the sensor is Maintenance or replacement


Sensor Over Temp Hardware error
greater than 40 °C of CO2 sensor

Hardware error, EEPROM check Maintenance or replacement


Sensor Faulty Hardware error
error, or module failure of CO2 sensor

27.6 System Alarm


1. When the parameter value is higher or lower than the alarm limits, the alarm will ring. Please check whether the
alarm limit value is proper or the condition of the patient.

2. Leads off. Please check the connection of the leads.

3. Probe off. Please check the connection of the probes.

27.7 Alarm Problems


Symptoms Possible cause Correction action

The alarm LED does not light Main board is defective Replace the main board

No alarm sound is issued Audible alarm is disabled


Check is the “ ” is displayed, if yes,
the audible alarm is disabled.

177
Operator’s Manual for Patient Monitor

Speaker is defective Replace the speaker

Main board is defective Replace the main board

27.8 Power Supply Failure


Symptoms Possible cause Correction action

Battery cannot be recharged Battery is defective Replace the battery


and/or fully charged
Main board is failure Replace the main board

27.9 Troubleshooting of IBP


Symptoms Possible cause Correction action

The pressure hardware may be faulty. Contact the


Equipment malfunction
manufacturer or your local dealer.

Confirm that you have selected the value for calibration


Out of range value that you applying to the transducer, and repeat
the calibration.
Unable to calibrate
No transducer is detected Check that the transducer is connected and try again

Confirm that there are no disturbance to transducer,


Unstable signal is measured
and repeat the calibration.

Perform zero first No valid zero. Zero the transducer first.

The pressure hardware may be faulty. Contact the


Equipment malfunction
manufacturer or your local dealer.

Excessive offset Confirm that the transducer is vented to air and try
again. If this fails, the hardware may be faulty, please
change a new adapter cable and try again. If it fails,
Unstable signal is measured change a new transducer and try again. If it still fails,
Unable to zero please contact the manufacturer or your local dealer.

Check that the transducer is connected and try again. If


No transducer is detected this fails, exchange the adapter cable and try again. If
this fails, exchange the transducer.

Confirm that the transducer is vented to air, bot to the


Plusatile pressure
patient, and try again.

178
Operator’s Manual for Patient Monitor

A Alarm Information
Alarm Information Descriptions

Over HR limit

Over RR limit

Over TEMP limit

Over SpO2 limit

Over PR limit The related parameter value exceeds the preset high/low alarm limits.
Over NIBP SYS limit

Over NIBP DIA limit

Over NIBP PR limit

Unable to detect HR ECG cable and leads are connected to monitor and patient well, but HR is

Unable to detect SpO2 SpO2 probe is connected to monitor and patient well, but SpO2 is unable

The battery capacity will exhaust Low battery voltage

Lead Off The ECG electrodes or cable fell off

Probe Off SpO2 probe fell off

179
Operator’s Manual for Patient Monitor

B Status/Error during NIBP Monitoring


“Cuff error” —cuff is not wrapped correctly, or is not connected

“Air leak” —Air moving part, tube or the cuff leak air.

“Pressure error” —Unstable cuff pressure or tangled cuff tubing

“Signal weak” —Very weak signal because of the cuff, or the patient has very weak pulse

“Over extent” —The measurement range exceeds 255 mmHg (Pediatric patient over 135 mmHg)

“Over motion” —The repeated measurement due to moving, excessive noise during the stepping inflation and
measuring pressure and pulse, e.g. during patient shaking motion

“Signal overflow” —Blood pressure amplifier overflow due to excessive movement

“Leak in gas run” —Leaking during the pneumatic device testing

“System error” —Abnormal condition of CPU, such as register overflow, divided by zero

“Adult” —The blood pressure measuring now is in adult mode. In this case, it is not allowed to monitoring
Pediatric or neonatal patient. Otherwise, there may be serious danger to the Pediatric
monitored.

“Pediatric” —The blood pressure module is now worked in Pediatric measuring mode.

“PROBE OFF” —SpO2 probe fell off

“LEADS OFF” —The ECG electrodes or cable fell off

“LEARNING” —Learning arrhythmia for 15 seconds

“DEMO” —The monitor is displaying the demo waveforms, which are generated by the monitor itself.

180
Operator’s Manual for Patient Monitor

C Status/Error during CO2 Monitoring


Suggested Message/Response Description
“Sensor Over Temp” The sensor temperature is greater than 40 °C.
Make sure sensor is not exposed to extreme heat
(heat lamp, etc.). If error persists, return sensor to
factory for servicing.
“Sensor Faulty” One of the following conditions exist:
Check that the sensor is properly plugged in. Source Current Failure,
Reinsert or reset the sensor if necessary. If error EEPROM Checksum Faulty,
persists, return sensor to factory for servicing
Hardware Error

No Parameter Message Barometric Pressure and/or gas compensations have not


The host must set the Barometric Pressure and been set since power on. For CO2 to be calculated with
compensations to clear this error; no user the stated accuracy, these values should be set whenever
intervention should be required.
the sensor is plugged in.

“Module in Sleep Mode” This bit is set when sensor has been placed in sleep
mode
“Zero In Progress “ A Module Zero is currently in progress.
One of the following conditions exist:
“Sensor Warm Up” Sensor under temperature
This error condition is normal at startup. This error Temperature not stable
should clear when the warm up is complete. Source Current unstable

“Check Sampling Line” This error occurs whenever the pneumatic pressure is
Check that the sampling line is not occluded or outside the expected range.
kinked.
“Zero Required” One of the following conditions exist:
To clear, check airway adapter and clean if Zero Required;
necessary. If this does not correct the error, Zero Required: Zero Error
perform an adapter zero. If you must adapter zero
more than once, a possible hardware error may
The value being calculated is greater than the upper CO2
“CO2 Out of Range” limit (150 mmHg, 20.0 kPa, or 19.7 %). The maximum
If error persists, perform a zero. value output is the upper CO2 limit.

“Check Airway Adapter” Usually caused when the airway adapter is removed from
the sensor or when there is an optical blockage on the
To clear, clean airway adapter if mucus or moisture windows of the airway adapter. May also be caused by
is seen. If the adapter is clean, perform a Capnostat failure to perform sensor zero to when adapter type is
zero. changed.

181
Operator’s Manual for Patient Monitor

This is prompted if the CO2 sensor is not ready for a


Capnostat Zero.

If the “Zero Required” and this massage both prompt


message both prompt one or more of the following
The Sensor
conditions may exist:
not Ready
• Breaths detected

• Temperature is not stable

• Source Current unstable

• In sleep mode.

Zero in already progress Normal zero calibration is in already progress.

Zero Fault and Breaths Detected Zero attempted and breaths have been detected in the
last 20 seconds.

Zero Ok Zero calibration is successful

D Typical Pressures and CO2 Readings at Altitudes


Barometric EtCO2 Reading
Altitude
Pressure(mmHg) (%) (mmHg)

0m 760 5 38.0
70m 754 5 37.7
100m 751 5 37.5
200m 743 5 37.1
1500m 641 5 32.0
3000m 537 5 26.8
5000m 420 5 21.0

182
Operator’s Manual for Patient Monitor

E EMC Compliance
Essential Performance

The monitor has the following essential performance in an environment of electromagnetic environment specified
below:

Operating mode, accuracy, function, alarm

Warnings

 Use of the monitor adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and other equipment should be observed to verify
that they are operating normally.

 Use of accessories, transducers and cables other than those specified or provided by the manufacturer of the
monitor could result in increased electromagnetic emissions or decreased electromagnetic immunity of the
monitor and result in improper operation.

 Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the monitor, including cables specified by the
manufacturer. Otherwise, degradation of the performance of the monitor could result.

 In operation mode, the monitor can be used with electro‐surgical unit. The monitor’s operator should ensure the
safety of the patients if in use with electro‐surgical unit in accordance with the instructions of this manual. After
the elimination of high frequency signal and high frequency electromagnetic field, the monitor waveform and
parameter can recover within 10 seconds without losing any stored data.

 Do not use the monitor with electro‐surgical unit in non‐operation mode, nor with large‐scale electrical
equipment such as ultrasonic, radiation and magnetic resonance imaging, which may cause electromagnetic
interference to the monitor or harm the monitor’s operator.

183
Operator’s Manual for Patient Monitor

Table 1
Guidance and manufacturer’s declaration‐electromagnetic emission‐ for all
EQUIPMENT AND SYSTEMS
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment or system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment‐guidance

RF emissions Patient Monitor uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic equipment.

RF emissions Patient Monitor is suitable for use in all establishments


Class A other than domestic and those directly connected to the
CISPR 11
public low‐voltage power supply network that supplies
Harmonic emissions buildings used for domestic purposes.
Class A
IEC61000‐3‐2

Voltage
fluctuations/flicker
emissions Complies

IEC61000‐3‐3

Note:

 The EMISSIONS characteristics of the monitor make it suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), the monitor
might not offer adequate protection to radio‐frequency communication services. The user might need to take
mitigation measures, such as relocation or re‐orienting the monitor.

 If the electromagnetic field strength in the location where monitor is used within 1.5km from the AM, PM, TV
broadcast exceeds the applicable RF compliance level (listed in Table 3), the monitor should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re‐orienting or relocating Monitor.

184
Operator’s Manual for Patient Monitor

Table 2
Guidance and manufacturer’s declaration‐electromagnetic immunity
for all EQUIPMENT AND SYSTEMS
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of
the equipment or system should assure that it is used in such an environment.

Immunity test IEC60601 test level Compliance level Electromagnetic environment ‐guidance

Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or


discharge(ESD) ceramic tile. if floors are covered with
±15kV air ±15kV air
synthetic material, the relative humidity
IEC61000‐4‐2
should be at least 30%

Electrical fast ±2kV for power ±2kV for power Mains power quality should be that of a
transient/burst typical commercial or hospital
Supply lines Supply lines
environment.
±1 kV for ±1 kV for
IEC61000‐4‐4
input/output lines input/output lines

Surge ±1kV line (s) to line(s) ±1kV differential Mains power quality should be that of a
mode typical commercial or hospital
IEC 61000‐4‐5 ±2kV line(s) to earth
environment.
±2kV common mode

Voltage dips, short Mains power quality should be that of a


interruptions and typical commercial or hospital
voltage variations on environment. If the user of the
power supply input lines equipment or system requires
continued operation during power
IEC61000‐4‐11
mains interruptions, it is recommended
that the equipment or system be
powered from an uninterruptible power
supply or a battery.

Power Power frequency magnetic fields should


frequency(50Hz/60Hz) be at levels characteristic of a typical
magnetic field 3A/m 3A/m location in a typical commercial or
hospital environment.
IEC61000‐4‐8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

185
Operator’s Manual for Patient Monitor

Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity‐for EQUIPMENT
and SYSTEM that are not LIFE‐SUPPORTING
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of
Patient Monitor should assure that it is used in such an electromagnetic environment.

IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment ‐ guidance

Portable and mobile RF communications


equipment should be used no closer to any part
of Patient Monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.

Recommended separation distance

3 Vrms

Conducted RF 150 kHz to 80 MHz 3V

IEC 61000‐4‐6

Where P is the maximum output power rating of


the transmitter in watts (W) according to the
transmitter manufacturer and d is the
3 V/m recommended separation distance in metres
(m). b
Radiated RF 80 MHz to 2.5 GHz 3 V/m
Field strengths from fixed RF transmitters, as
IEC 61000‐4‐3 determined by an electromagnetic site survey ,a
should be less than the compliance level in each
frequency range .b

Interference may occur in the vicinity of


equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey
should be considered. If the measured field strength in the location in which Patient Monitor is used exceeds the
applicable RF compliance level above, Patient Monitor should be observed to verify normal operation. If abnormal

186
Operator’s Manual for Patient Monitor

performance is observed, additional measures may be necessary, such as re‐orienting or relocating Patient Monitor.

b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the equipment or system‐
for EQUIPMENT and SYSTEM that are not LIFE‐SUPPORTING
Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the equipment or system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the equipment or system as recommended below, according to the maximum
output power of the communications equipment.

Separation distance according to frequency of transmitter


Rated maximum output
m
power of transmitter
150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz
W

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where
p is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

187

You might also like