Elite View Ev100

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BPL ELITE VIEW EV100

Modular Patient Monitor

www.bplmedicaltechnologies.com Follow us on
Responsibility of the Marketer
BPL Medical Technologies Private Limited otherwise referred as BPLMTPL in this manual only considers itself
responsible for any effects on safety, reliability and performance of the equipment if:

o Assembly, operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorised by BPLMTPL.

o The device is used according to the instructions for use presented in this manual.

o The device is transported, stored & used in environment conditions as specified in User’s Manual.

o Accessories used are only those recommended by BPLMTPL.


Operating Manual
BPL ELITE VIEW EV100
640-D-001
REV: 1.0

This User’s Manual is prepared with the objective of providing the user with all the
information necessary to obtain the best use of BPL ELITE VIEW EV100.

In addition to the description of the device functions, the following documentation will be
found with this manual:

1. Warranty Certificate BPL Medical Technologies Private Limited.

For the purpose of improvement and betterment, Specifications and Operating


Characteristics of the BPL ELITE VIEW EV100 are subject to change without prior notice.
Statement
This manual contains exclusive information protected by copyright laws and we reserve its
copyright. Without written approval of manufacturer, no parts of this manual shall be
photocopied, xeroxed or translated into other languages.
The contents and version contained in this manual are subject to amendments without
notification.
The version number of this manual: Ver 1.0

Contact Details

Marketed By:
BPL Medical Technologies Private Limited
11th KM, Bannerghatta Road,
Arekere, Bangalore – 560076
Karnataka, India
www.bplmedicaltechnologies.com
Preface

Thank you for using BPL ELITE VIEW EV100.

In order to enable you to skilfully operate BPL ELITE VIEW EV100 as soon as possible, we provide this
user's manual with device. When you install and use this device for the first time, it is imperative that
you read carefully all the information that accompanies this device.

Based on the need to improve the performance and reliability of the parts and the whole device, we
sometimes will make some amendments to the device (including the hardware and software). As a
result, there might be cases of discrepancies between the manual and the actual situation of
products. When such discrepancies occur, we will try our best to amend or add materials. Your
comments and suggestions are welcome.
Contents
Chapter 1 ..............................................................................................................................1-1
Safety.........................................................................................................................................1-1
1.1 Safety Information ...................................................................................................................... 1-1
1.2 Symbols ......................................................................................................................................... 1-3
Chapter 2 ..............................................................................................................................2-1
Overview ...................................................................................................................................2-1
2.1 Intended Use................................................................................................................................. 2-1
2.2 Components.................................................................................................................................. 2-1
2.3 Contraindications ........................................................................................................................ 2-1
2.4 Appearance Introduction ........................................................................................................... 2-1
2.4.1 Front View ......................................................................................................................... 2-1
2.4.2 Left View ........................................................................................................................... 2-3
2.4.3 Right View ......................................................................................................................... 2-3
2.4.4 Rear View .......................................................................................................................... 2-4
2.4.5 Top View............................................................................................................................ 2-5
2.5 On-screen Display ....................................................................................................................... 2-6
Chapter 3 ..............................................................................................................................3-1
Installation ................................................................................................................................3-1
3.1 Unpackand Check ........................................................................................................................ 3-1
3.2 Connect AC Power Cord ............................................................................................................. 3-1
3.3 Turn on the Monitor .................................................................................................................... 3-1
3.4 Connect Sensors .......................................................................................................................... 3-1
Chapter 4 ..............................................................................................................................4-1
Basic Operations ........................................................................................................................4-1
4.1 Using the Main Menu .................................................................................................................. 4-1
4.2 General Settings .......................................................................................................................... 4-1
4.2.1 Settings the System Time ............................................................................................. 4-1
4.2.2 Changing System Language ......................................................................................... 4-1
4.2.3 Adjusting Alarm Volume................................................................................................ 4-1
4.2.4 Adjusting Heartbeat Volume ........................................................................................ 4-2
4.2.5 Adjusting Key Volume.................................................................................................... 4-2
4.2.6 Adjusting Screen Brightness ........................................................................................ 4-2
4.3 Monitor Information ................................................................................................................... 4-2
4.4 Module Setup ............................................................................................................................... 4-2
4.5 Demo Function ............................................................................................................................. 4-2
4.6 Locking the Touch Screen.......................................................................................................... 4-3
4.7 Network Settings ......................................................................................................................... 4-3
4.8 Freezing Waveforms ................................................................................................................... 4-4
Chapter 5 ..............................................................................................................................5-1
Patient Management..................................................................................................................5-1
5.1 Admitting Patient ........................................................................................................................ 5-1
5.2 Patient Information ..................................................................................................................... 5-2
5.3 Discharging Patient ..................................................................................................................... 5-2
5.4 Data Management ....................................................................................................................... 5-2
5.4.1 View Historical Data ....................................................................................................... 5-2
5.4.2 Export Historical Data .................................................................................................... 5-3
Chapter 6 ..............................................................................................................................6-1
User Screens ..............................................................................................................................6-1
6.1 Overview ....................................................................................................................................... 6-1
6.1.1 Standard Screen .............................................................................................................. 6-1
6.1.2 BigFont Screen ................................................................................................................. 6-1
6.1.3 Trend Screen .................................................................................................................... 6-2
6.1.4 OxyCRG Screen ................................................................................................................ 6-3
6.1.5 List Screen......................................................................................................................... 6-4
6.1.6 Cascade Screen................................................................................................................ 6-4
6.1.7 Other Screens................................................................................................................... 6-5
6.2 Tailoring Your Screens ............................................................................................................... 6-5
6.2.1 Changing the Waveform Sweep Speed ..................................................................... 6-5
6.2.2 Setting the Waveform Display Style .......................................................................... 6-6
6.2.3 Setting the DisplayColor ............................................................................................... 6-6
6.2.4 Waveform Exchange....................................................................................................... 6-6
Chapter 7 ..............................................................................................................................7-1
Alarm .........................................................................................................................................7-1
7.1 Alarm Type .................................................................................................................................... 7-1
7.2 Alarm Level ................................................................................................................................... 7-1
7.3 Alarm Mode ................................................................................................................................... 7-2
7.4 Visual Alarm .................................................................................................................................. 7-2
7.5 Audio Alarm .................................................................................................................................. 7-2
7.6 Alarm Message ............................................................................................................................. 7-2
7.7 Alarm Parameter Flashing ......................................................................................................... 7-3
7.8 Adjusting the Alarm Volume ..................................................................................................... 7-3
7.9 Alarm Settings .............................................................................................................................. 7-3
7.9.1 Activating or Deactivating Parameter Alarm Function .......................................... 7-3
7.9.2 Setting the Alarm Level ................................................................................................. 7-4
7.9.3 Setting the Alarm Limit .................................................................................................. 7-4
7.9.4 Alarm Recording .............................................................................................................. 7-6
7.9.5 Setting the Alarm Delay Time ...................................................................................... 7-6
7.10 Pausing alarms ............................................................................................................................. 7-6
7.11 Check the Alarm System ............................................................................................................ 7-6
Chapter 8 ..............................................................................................................................8-1
Battery .......................................................................................................................................8-1
8.1 General Introduction .................................................................................................................. 8-1
8.2 Low Battery Alarm ....................................................................................................................... 8-1
8.3 Battery Management .................................................................................................................. 8-1
8.4 Battery Installation...................................................................................................................... 8-2
8.5 Optimization and Check of Battery Performance ................................................................ 8-2
8.6 Battery Recycle ............................................................................................................................ 8-3
Chapter 9 ..............................................................................................................................9-1
Review .......................................................................................................................................9-1
9.1 NIBP Measurement Review ....................................................................................................... 9-1
9.2 AlarmEvent Review ..................................................................................................................... 9-2
9.3 Trend Review ................................................................................................................................ 9-4
9.3.1 Trend GraphReview ........................................................................................................ 9-4
9.3.2 Trendtable Review .......................................................................................................... 9-5
9.4 ECG Waveform Review............................................................................................................... 9-6
9.5 Diagnosis Report Review under ECG Mode .......................................................................... 9-7
Chapter 10 ....................................................................................................................... 10-1
Calculation.............................................................................................................................. 10-1
10.1 Drug Calculation ........................................................................................................................ 10-1
10.1.1 Calculation Steps .......................................................................................................... 10-2
10.1.2 Titration List Display .................................................................................................... 10-3
10.2 Hemodynamic Calculation ...................................................................................................... 10-3
10.2.1 Calculation Steps .......................................................................................................... 10-4
10.2.2 Input Parameters ........................................................................................................... 10-4
10.2.3 Output Parameters ....................................................................................................... 10-5
10.3 Ventilation Calculation ............................................................................................................ 10-5
10.3.1 Calculation steps ........................................................................................................... 10-6
10.3.2 Input Parameters ........................................................................................................... 10-6
10.3.3 Output Parameters ....................................................................................................... 10-6
10.4 Oxygenation Calculation ......................................................................................................... 10-7
10.4.1 Calculation Steps .......................................................................................................... 10-7
10.4.2 Input Parameters ........................................................................................................... 10-7
10.4.3 Output Parameters ....................................................................................................... 10-8
10.5 Renal Calculation ....................................................................................................................... 10-8
10.5.1 Calculation Steps .......................................................................................................... 10-9
10.5.2 Input Parameters ........................................................................................................... 10-9
10.5.3 Output Parameters .................................................................................................... 10-10
Chapter 11 ....................................................................................................................... 11-1
Cleaning and Disinfection ...................................................................................................... 11-1
11.1 Overview ..................................................................................................................................... 11-1
11.2 Cleaning and Disinfection of the Monitor and Accessories ............................................ 11-1
11.3 Cleaning and Disinfection of the Cuff .................................................................................. 11-3
Chapter 12 ....................................................................................................................... 12-1
Maintenance ........................................................................................................................... 12-1
12.1 Maintenance Check ................................................................................................................... 12-1
12.2 Maintenance Schedule ............................................................................................................. 12-1
12.3 ECG calibration........................................................................................................................... 12-2
12.4 NIBP Air Leakage Test ............................................................................................................... 12-2
12.5 NIBP Pressure Calibration........................................................................................................ 12-3
12.6 IBP Calibration ............................................................................................................................ 12-4
12.7 Touch Screen Calibration ........................................................................................................ 12-4
Chapter 13 ....................................................................................................................... 13-1
Patient Safety ......................................................................................................................... 13-1
13.1 Safety Instruction ...................................................................................................................... 13-1
13.2 Environment ............................................................................................................................... 13-1
13.3 Grounding Protection ............................................................................................................... 13-1
13.4 Equipotential Grounding ......................................................................................................... 13-1
13.5 Condensation ............................................................................................................................. 13-2
Chapter 14 ....................................................................................................................... 14-1
Recording (optional) ............................................................................................................... 14-1
14.1 Recorder Installation ................................................................................................................ 14-1
14.2 Loading Record Paper............................................................................................................... 14-1
14.3 Printing......................................................................................................................................... 14-1
14.3.1 Printing under Monitoring Mode ............................................................................... 14-1
14.3.2 Manual Printing under ECG Mode ............................................................................. 14-2
14.3.2.1 Auto Printing under ECG Mode ......................................................................................... 14-2
14.3.3 Rhythm Printing under ECG Mode ............................................................................ 14-3
14.3.4 VCG Printing under ECG Mode ................................................................................... 14-4
14.4 Print Settings .............................................................................................................................. 14-5
14.4.1 Print Settings under Monitoring Mode .................................................................... 14-5
14.4.2 Printing Settings under ECG Mode ........................................................................... 14-5
Chapter 15 ....................................................................................................................... 15-1
ECG Monitoring ....................................................................................................................... 15-1
15.1 Overview ..................................................................................................................................... 15-1
15.2 ECG Display ................................................................................................................................. 15-1
15.3 Safety Information .................................................................................................................... 15-2
15.4 Steps of Monitoring .................................................................................................................. 15-2
15.4.1 Preparation ..................................................................................................................... 15-2
15.4.2 Placement of ECG Electrodes ..................................................................................... 15-3
15.4.2.1 Identifiers and Color Code of Electrodes ....................................................................... 15-3
15.4.2.2 Placement of 3-lead ECG Electrodes............................................................................... 15-3
15.4.2.3 Placement of 5-lead ECG Electrodes............................................................................... 15-4
15.4.2.4 Placement of Reformed 12-lead ECG Electrodes ........................................................ 15-5
15.4.2.5 ECG Lead Connection Recommended for Surgical Patients ...................................... 15-6
15.5 Waveform Quality ..................................................................................................................... 15-6
15.6 ECG Settings................................................................................................................................ 15-7
15.6.1 Setting the Lead Type .................................................................................................. 15-7
15.6.2 Setting the Lead Name................................................................................................. 15-7
15.6.3 Setting the Gain ............................................................................................................. 15-7
15.6.4 Setting the Filter Mode ................................................................................................ 15-8
15.6.5 Setting the Calculation Channel................................................................................ 15-8
15.6.6 Setting the Notch .......................................................................................................... 15-8
15.6.7 Setting the Heart Rate Source.................................................................................... 15-9
15.6.8 Activating or deactivating the Auto Lead Switch Function ................................. 15-9
15.7 ST Segment Analysis ................................................................................................................. 15-9
15.7.1 About ST Segment Analysis ........................................................................................ 15-9
15.7.2 Impact on ST-segment ................................................................................................. 15-9
15.7.3 On/Off ST Segment Analysis ................................................................................... 15-10
15.7.4 Setting the ST Segment Analysis Point ................................................................. 15-10
15.8 Arrhythmia Analysis ............................................................................................................... 15-11
15.8.1 On/Off Arrhythmia Analysis .................................................................................... 15-12
15.8.2 Arrhythmia Alarm Settings....................................................................................... 15-12
15.8.3 Arrhythmia Relearning.............................................................................................. 15-12
15.8.4 Arrhythmia Review .................................................................................................... 15-12
Chapter 16 ....................................................................................................................... 16-1
Respiration Monitoring........................................................................................................... 16-1
16.1 Respiration .................................................................................................................................. 16-1
16.2 Respiration Display ................................................................................................................... 16-1
16.3 Placing Electrodes for RESP Measurement ......................................................................... 16-1
16.4 RESP Settings .............................................................................................................................. 16-3
16.4.1 Setting the Gain ............................................................................................................. 16-3
16.4.2 Setting the Apnea Alarm Time ................................................................................... 16-3
16.4.3 Setting the RESP Lead .................................................................................................. 16-3
16.4.4 Setting the RESP Filter ................................................................................................. 16-3
Chapter 17 ....................................................................................................................... 17-1
SpO2 Monitoring ..................................................................................................................... 17-1
17.1 Definition of SpO2 Monitoring ............................................................................................... 17-1
17.1.1 Principle of Measuring SpO2 ...................................................................................... 17-1
17.1.2 Recognition of the type of SpO2 Sensor ................................................................. 17-1
17.2 SpO2 Display .............................................................................................................................. 17-2
17.3 Safety Information .................................................................................................................... 17-2
17.4 Steps of Monitoring .................................................................................................................. 17-3
17.5 Limits in Measurement ............................................................................................................. 17-4
17.6 SpO2 Settings .............................................................................................................................. 17-5
17.6.1 Setting the Intelligent Alarm ...................................................................................... 17-5
17.6.2 Setting the Average Time ............................................................................................ 17-6
17.6.3 Setting the Calculation Sensitivity ........................................................................... 17-6
17.6.4 Setting the Signal IQ..................................................................................................... 17-7
17.6.5 Setting the Quick SpO2 ................................................................................................ 17-7
17.6.6 Setting the Pulse Sound .............................................................................................. 17-7
17.7 Masimo Information.................................................................................................................. 17-7
Chapter 18 ....................................................................................................................... 18-1
NIBP Monitoring ...................................................................................................................... 18-1
18.1 Overview ..................................................................................................................................... 18-1
18.2 NIBP Display................................................................................................................................ 18-1
18.3 Precautions for NIBP measurement ...................................................................................... 18-2
18.4 NIBP Measurement .................................................................................................................... 18-2
18.4.1 Measurement Steps ...................................................................................................... 18-2
18.4.2 Operation Prompt ......................................................................................................... 18-4
18.4.3 Measurement Limitations ........................................................................................... 18-5
18.5 NIBP Settings .............................................................................................................................. 18-6
18.5.1 Setting the Measure Mode .......................................................................................... 18-6
18.5.2 Setting the Interval Time............................................................................................. 18-6
18.5.3 Setting the Pressure Unit ............................................................................................ 18-6
18.5.4 Setting the Pre-inflation Value .................................................................................. 18-6
18.6 NIBP Reset ................................................................................................................................... 18-6
Chapter 19 ....................................................................................................................... 19-1
Temperature Monitoring ........................................................................................................ 19-1
19.1 Overview ..................................................................................................................................... 19-1
19.2 TEMP Display .............................................................................................................................. 19-1
19.3 Safety Information .................................................................................................................... 19-1
19.4 Steps of TEMP Measurement .................................................................................................. 19-1
19.5 Setting the TEMP Unit ............................................................................................................... 19-2
Chapter 20 ....................................................................................................................... 20-1
CO2 Monitoring ....................................................................................................................... 20-1
20.1 Overview ..................................................................................................................................... 20-1
20.2 Understanding CO2Plug-in Modules ..................................................................................... 20-1
20.3 Measuring Principle and Working Process .......................................................................... 20-2
20.4 Operating Instruction for CO2 Connection ......................................................................... 20-2
20.5 Measuring Procedure of RESPIRONICS Mainstream and Sidestream Modules .......... 20-4
20.6 Measuring Procedure of PHASEIN Sidestream and Mainstream Analyzers ................. 20-6
20.6.1 Measurement Steps ...................................................................................................... 20-6
20.6.2 Pre-use Check ................................................................................................................ 20-6
20.7 CO2 Setting ................................................................................................................................. 20-7
20.7.1 Setting the Pressure Unit ............................................................................................ 20-7
20.7.2 Setting the Gas Compensation .................................................................................. 20-7
20.7.3 Setting the Apnea Alarm Time ................................................................................... 20-7
20.7.4 Setting theAltitude ....................................................................................................... 20-8
20.7.5 Setting theBalance Gas ................................................................................................ 20-8
20.8 Discharging Waste Gases ........................................................................................................ 20-8
20.9 Zeroing of RESPIRONICS Mainstream and Sidestream Module ...................................... 20-8
20.10 PHASEIN Mainstream and Sidestream Analyzer Related Information ...................... 20-9
20.10.1 Zeroing............................................................................................................................. 20-9
20.10.2 CO2 Module Indicator Status ..................................................................................... 20-9
20.10.3 Others .............................................................................................................................. 20-9
Chapter 21 ....................................................................................................................... 21-1
AG Monitoring......................................................................................................................... 21-1
21.1 Overview ..................................................................................................................................... 21-1
21.2 Understanding the AG Module ............................................................................................... 21-1
21.3 Measurement Principle of Anaesthetic Gas ........................................................................ 21-1
21.4 AG Display ................................................................................................................................... 21-2
21.5 MAC (Minimum Alveolar Concentration) Calculation ....................................................... 21-3
21.6 Oxygen Sensors ......................................................................................................................... 21-3
21.7 Measurement Steps and Pre-use Check............................................................................... 21-4
21.8 AGSettings ................................................................................................................................... 21-6
21.8.1 Setting the Work Mode ................................................................................................ 21-6
21.8.2 Setting Gas Compensation ......................................................................................... 21-6
21.8.3 Setting the Pressure Unit ............................................................................................ 21-7
21.8.4 Setting the Apnea Alarm Time ................................................................................... 21-7
21.9 Zeroing ......................................................................................................................................... 21-7
21.10 AG Module Indicator Status ................................................................................................ 21-7
21.11 Adverse Effects on Performance ....................................................................................... 21-8
21.12 Safety Information ................................................................................................................ 21-9
21.12.1 ISA Sidestream Gas Analyzer Safety Information ................................................. 21-9
21.12.2 IRMA Mainstream Gas Analyzer Safety Information .......................................... 21-11
21.13 Airway Obstruction ............................................................................................................ 21-12
21.14 Discharging Waste Gases ................................................................................................. 21-12
21.15 Consumables ....................................................................................................................... 21-12
21.16 Safety Symbol ..................................................................................................................... 21-13
21.17 Maintenance ........................................................................................................................ 21-14
21.18 Patents and Trademarks ................................................................................................... 21-14
Chapter 22 ....................................................................................................................... 22-1
IBP Monitoring ........................................................................................................................ 22-1
22.1 Overview ..................................................................................................................................... 22-1
22.2 Understanding IBP Modules .................................................................................................... 22-1
22.3 Safety Information .................................................................................................................... 22-1
22.4 Steps of Monitoring .................................................................................................................. 22-2
22.5 IBP Pressure Zeroing ................................................................................................................. 22-3
22.6 IBPSettings .................................................................................................................................. 22-4
22.6.1 Changingthe Pressure Label....................................................................................... 22-4
22.6.2 Setting the Filter Mode ................................................................................................ 22-4
22.6.3 Adusting the Pressure Scale ....................................................................................... 22-4
22.6.4 Setting the Pressure Unit ............................................................................................ 22-5
Chapter 23 ....................................................................................................................... 23-1
ICG Monitoring ........................................................................................................................ 23-1
23.1 Overview ..................................................................................................................................... 23-1
23.2 ICG Display .................................................................................................................................. 23-1
23.3 Understanding the ICG Module .............................................................................................. 23-1
23.4 Safety Information .................................................................................................................... 23-2
23.5 ICG Parameters........................................................................................................................... 23-2
23.5.1 Hemodynamic Parameters.......................................................................................... 23-2
23.5.2 List of Hemodynamic Parameters ............................................................................. 23-2
23.6 Influencing Factors.................................................................................................................... 23-2
23.7 Steps of Monitoring .................................................................................................................. 23-3
23.7.1 Skin Preparation ............................................................................................................ 23-3
23.7.2 Placing the Sensors ...................................................................................................... 23-3
23.8 ICG Settings................................................................................................................................. 23-4
23.8.1 Entering Patient Information ..................................................................................... 23-4
23.8.2 Changing the Secondary Parameter ......................................................................... 23-4
23.9 Trouble Shooting ....................................................................................................................... 23-5
Chapter 24 ....................................................................................................................... 24-1
C.O. Monitoring ...................................................................................................................... 24-1
24.1 Overview ..................................................................................................................................... 24-1
24.2 C.O. Display ................................................................................................................................. 24-1
24.3 Understanding C.O. Module .................................................................................................... 24-1
24.4 Safety Information .................................................................................................................... 24-1
24.5 Measurement Principle ............................................................................................................ 24-2
24.6 C.O. Settings................................................................................................................................ 24-2
24.6.1 Setting the C.O. Coefficient ........................................................................................ 24-2
24.6.2 Changing the Source of Injection Temperature .................................................... 24-2
24.6.3 Entering the Injection Temperature ......................................................................... 24-2
24.6.4 Changing the Temperature Unit ................................................................................ 24-3
24.6.5 Setting Measurement Interval ................................................................................... 24-3
24.6.6 Setting the Injection Volume ..................................................................................... 24-3
24.7 Steps of C.O. Measurement ..................................................................................................... 24-3
24.8 Measuring the Blood Temperature ....................................................................................... 24-5
24.9 Influencing Factors.................................................................................................................... 24-5
Chapter 25 ....................................................................................................................... 25-1
View Telemetry Data on Monitor (OPTIONAL FEATURE) ......................................................... 25-1
25.1 Connection .................................................................................................................................. 25-1
25.2 Bedside Monitor Controls Telemetry Monitor.................................................................... 25-2
25.3 Cancel the Connection Between Beside Monitor and Telemetry Monitor .................. 25-3
Appendix I .................................................................................................................. I-1
Product Configuration ...................................................................................................... I-1
Appendix II ................................................................................................................. II-1
Accessories ..................................................................................................................... II-1
Appendix III ................................................................................................................ III-1
Product Specification ..................................................................................................... III-1
Appendix IV ................................................................................................................IV-1
System Alarm Message ...................................................................................................IV-1
Appendix V ................................................................................................................ V-1
Guidance and Manufacturer’s Declaration ...................................................................... V-1
Chapter 1
Safety
1.1 Safety Information
Warning
 To warn you of the conditions where serious consequence, disadvantageous matters or
danger may occur. Failure to comply with the warning will result in severe personal injury
or death of the user or the patient.

Caution
 To indicate potential danger or unsafe operation. If not avoided, it may lead to mild
personal injury, product malfunction, damages or property loss. It may also give rise to
more severe harm.

Attention
 It emphasizes primary warnings or provides descriptions or explanations so that this
product can be used in a better way.

Warning
 This monitor is used for monitoring the clinical patients, and only the doctors and
nurses who are qualified through training can use this monitor.
 Check whether this instrument and its accessories can work normally and safely prior to
use.
 The alarm volume and alarm limits shall be set for different patients. When a patient is
monitored, the audible alarm system cannot be merely depended on. If the alarm volume
is set too low or is completely turned off, the alarm will not be heard and the patient will
be endangered. The most reliable patient monitoring method shall be keeping the
patient under close surveillance.
 This instrument can only be connected to a power socket with protective grounding. If
the power socket is not connected to grounding conductor, do not use this socket, but
use the battery for power supply.
 Do not open the enclosure of this instrument to avoid the possible electric shock. The
maintenance and upgrading of this instrument must be conducted by the service
personnel trained and authorized by BPLMTPL.
 The disposal of packaging materials shall comply with the local laws and regulations or
the waste disposal rules and regulations of the hospital. Keep the packaging materials
out of the reach of the children.
 Do not use this instrument at the place where there are flammable articles such as
anesthetic to prevent explosion or fire from happening.
1-1
 Please carefully install the power lines and the cables for various accessories to avoid
entanglement or potential strangulation and keep the patient free from electrical
interference.
 Do not use mobile phone near the monitor, because the mobile phone will generate a
very strong radiation field and disturb the functions of the monitor.
 For the patient with pacemaker, cardio tachometer might measure the pacing pulse in
case of cardiac arrest or arrhythmia. Do not completely rely on the alarm of cardio
tachometer. The patient with pacemaker shall be closely monitored.
 The operators shall not touch the patients, tables and instruments during defibrillation.
Before reusing the cables, check whether their functions are normal.
 The equipment connected with the monitor shall form an equipotential body (the
protective grounding wire is effectively connected).
 When the monitor is used in conjunction with electro surgery unit, the user (doctor or
nurse) shall ensure the patients’ safety.
 The physiological waveforms, physiological parameters and alarm message, etc.
displayed by this monitor shall be for the doctors’ reference only and cannot be directly
used as the clinical treatment basis.
 The electromagnetic field will affect the performance of this monitor, so the use of the
other equipments, for example Mobile phone, X-ray or MRI equipment, near this monitor
must meet corresponding EMC requirements, because they will transmit high-strength
electromagnetic radiation.
 This is not a treatment device.

Caution
 To avoid damage to this instrument and guarantee patient safety, please use the
accessories designated in this user manual.
 Please properly install or move this instrument and prevent the instrument from being
damaged due to fall, collision, strong vibration or other external mechanical forces.
 Before the instrument is switched on, please confirm that the power supply used meets
the requirements for power supply voltage and frequency designated in the nameplate
label or in the user manual of this instrument.
 When this instrument and its accessories are about to exceed the service life, they must
be disposed of according to local relevant laws and regulations or the rules and
regulations of the hospital.

1-2
Attention
 Please install the equipment in a place that is convenient for observation, operation and
maintenance.
 This user manual is based on the maximum configuration, and therefore some contents
may not apply to your monitor.
 Please place this user manual near the instrument for easy and timely reference.
 This instrument cannot be used at home.
 This instrument can only be used for one patient at one time.
 The service life of the monitor is 5 years.

1.2 Symbols
(1) Product Symbols
Defibrillation-proof type
Caution!
BF applied part

Defibrillation-proof type
Alarm pause key
CF applied part

Power ON/OFF AC indicator

Recording key Serial Number

ECG/Monitoring mode
Equipotential grounding
switch key

Battery work indicator Network

Battery charge indicator Main Menu

DVI interface Nurse calling socket


Separate collection for
Defibrillator connector electrical and electronic
equipment

Refer to instruction
USB
manual/booklet

Protection against
Freeze key vertically falling water
drops
(2) Package Symbols

This side up Maximum stacking layer

Fragile Keep dry

1-3
Chapter 2
Overview
2.1 Intended Use
The Monitor can monitor or measure neonate’s, pediatric and adult’s physiological signs such as
ECG, NIBP, IBP, C.O., ICG, AG, SpO2, TEMP, RESP, PR and EtCO2, and it can also diagnose ECG for
outpatients and inpatients with respiratory oxygenation chart and drug calculation function.

2.2 Components
The Monitor is composed of the main unit with standard parameters i.e. 12 lead ECG, Respiration,
NIBP, Spo2, Temperature and optional Parameters i.e. IBP module, ICG module, C.O. module, AG
module, EtCO2 module, 12 Lead ECG Thermal recorder(216mm) and its accessories. The monitor
is capable of handling 2 Plug In modules also.

2.3 Contraindications
None.

2.4 Appearance Introduction


The monitor is equipped with a 12.1-inch TFT color touch screen. Operations can be done by
pressing the keys or touching the screen.

2.4.1 Front View

③ ②

Figure 2-1 Front view

2-1
① Display screen

Alarm pause key Press to put the alarm system into alarm paused
status

Freeze key Press to freeze or unfreeze the waveforms on the


screen.

Recording key Press to start recording or stop recording


NIBP start key Press to start or stop the NIBP measurement.

Main menu Press to access main menu or exit any menu


or window.

Rotate clockwise or anticlockwise to move the


Knob cursor and highlight menu items; press to
perform a certain operation.

ECG/Monitoring Press to switch between ECG mode and


mode switch key Monitoring mode

Power ON/OFF

On: when the monitor is connected with AC power


supply
AC
indicator
Off: when the monitor is disconnected with AC power
supply


On: when the battery is used to power the monitor
Battery wor
k indicator
Off: when the battery is not used to power the monitor
or no battery is installed

Battery On: when the battery is being charged


charge
indicator Off: when the battery is fully charged or no battery is
installed

2-2
Alarm
④ Physiological alarm lamp(left); Technical alarm lamp (right)
lamp

2.4.2 Left View

Handle

Recorder slot
Sensor sockets

Plug-in module slot

Figure 2-2 Left view (without modules and recorder plugged in)

2.4.3 Right View

Recorder

Plug-in modules

Figure 2-3 Right view (with modules and recorder plugged in)
2-3
Attention
 Only plug-in modules produced by BPLMTPL can be inserted into the plug-in module slot
and only the 12-lead ECG recorder produced by BPLMTPL can be inserted into the
recorder slot.
 This monitor only can be compatible with the plug-in modules produced by BPLMTPL.

2.4.4 Rear View


Handle

Recorder

Recorder lock catch Recorder latch

Battery

Nameplate labeling

Nurse call socket Defibrillator


connector

USB connector
DVI interface

Network
connector Equipotential

Power socket
Figure2-4 Rear View

2-4
Warning
 The network connector is designed for BPLMTPL central monitoring system only.
 Only the analog or digital equipments complying with the specified IEC standards (like
IEC 60950 for data processing equipments, IEC 60601-1 for medical equipments, etc.)
are allowed to be connected to the monitor. The configuration of these equipments
should comply with the valid version of IEC 60601-1-1 standards. The person who
connects external equipments to the signal I/O ports should configure the medical
system and ensure the medical system complies with IEC 60601-1-1 standards. If you
have any question, please contact the supplier.
 If more than one external equipment are connected to the monitor at one time through
the patient cable socket, network connector or other signal interfaces, the total leakage
current should not exceed the allowance.

2.4.5 Top View

AC power cable and


AC anti-drawing ring

Recorder paper exit


Label for
how to install
the recorder Recorder indicator

Figure2-5 Top view

Recorder indicator:
On: when an error occurred to the communication of the
ERROR indicator recorder or when the recorder door is open.

Off: when recorder works correctly.

On: when the recorder works correctly.


POWER indicator
Off: when an error occurred to the recorder or when the
recorder is not installed correctly

2-5
2.5 On-screen Display
The TFT color touch screen can display the patient parameters, waveform, alarm message,
system time, network connection status, bed number, battery status and other messages
simultaneously.

1 2 3 4 5 6 7

8
9

10

Figure 2-6 Screen Display

1. Network Connection Icon


 Show the network connection status between monitor and central monitoring system.

 indicating that the network between the monitor and central monitoring system
has not been connected successfully;

 indicating that the network between the monitor and central monitoring system
has been connected successfully;
 Click the network connection icon to directly access [NETWORK SET] menu.
2. Patient information area
 Display patient name, patient type, bed number, pacemaker status and so on. The icon

indicates the patient with pacemaker.


 Click here to directly access [PATIENT INFO] menu.
3. Icons area
Under monitoring mode:

Indicating the monitor is in silent status. If new alarm happens, the silent status will end
2-6
immediately.

: Indicating the monitor is in alarm paused status with alarm pause countdown displayed
in physiological alarm message area, like “*** ALM PAUSE 119s”.

: Indicating the alarm volume is 0.


Under ECG mode:

: Indicating the heartbeat.


4. Technical alarm message area
 Display technical alarm message and status message. When there are multiple
messages, they will be displayed circularly.
 Click here to directly access [TECHNIC ALARM REVIEW] window.
5. Physiological alarm message
 Display physiological alarm message. When there are multiple messages, they will be
displayed circularly.
 Click here to directly access [ALARM HIST] window.
6. Battery icon
 Display the current battery level
 Click it to directly access [BATTERY MANAGEMENT] menu.
7. System time
 Display the system time
 Click here to directly access [UPDATE SYSTEM TIME] menu.
8. Waveform area
 Display the measurement waveforms with the waveform name at the left top corner.
 Click the waveform area and the corresponding setup menu will be displayed.
9. Parameter area
 Display the measured value and the set alarm limit of each measurement parameter.
 The color of a certain parameter is the same as that of its waveform.
 Click each parameter area and the corresponding setup menu will be displayed.
10. On-screen keys
Click each on-screen key and the corresponding setup menu will be displayed or a certain

operation will be performed. Click or to show more on-screen keys.


On-screen keys under monitoring mode are as follows:

On-screen keys under ECG mode are as follows:

2-7
Installation

Chapter 3
Installation
3.1 Unpackand Check
Carefully unpack the monitor and accessories from the box, and save the packaging materials for
later transport or storage. Please check the accessories according to the packing list. Check if
there is any mechanical damage. Check all the external wires and connect accessories for test. If
there is any question, please contact distributor or BPLMTPL immediately.

3.2 Connect AC Power Cord


Before connecting the power cord, confirm that the AC power supply meets the following
specifications: A.C.100V~240V,50Hz/60Hz1Hz.
Use the power cord provided along with the monitor, and connect the power plug to the
grounded three-phase socket.
Attention
 Plug the power cord to the dedicated hospital socket.
 If a battery is provided, you must charge the battery after the transport or storage of this
monitor. If you do not connect the AC power and directly turn on the monitor, it may
not work because of insufficient battery power. Connect to the AC power supply and you
can charge the battery no matter whether the monitor is turned on or not.

3.3 Turn on the Monitor


Press the power on/off switch on the front panel and the system begains self-test. The
physiological alarm lamp and technical alarm lamp turn red and blue respectively, and then turn
yellow and blue respectively. The system will enter the main screen and gives a beep at the
same time after showing the company logo and loading configuration files. .

Attention
 If there are significant errors in the self-test, the system will alarm.
 Check all monitoring functions to ensure that the monitor is functional.
 Turn on the monitor again one minute after turning off.

Warning
 If any damage to the monitor or an error message is found, do not use this monitor for
patient monitoring. Please contact the biomedical engineer of your hospital or
maintenance engineer of BPLMTPL.

3.4 Connect Sensors


Connect the required sensor to the monitor and the monitoring part of patient.For the correct
connection methods and related requests, please refer to relevant chapters.

3-1
Chapter 4
Basic Operations
4.1 Using the Main Menu
How to access [Main Menu]:

Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN MENU]
and perform operations and settings.

Figure 4-1 Main menu

Attention
 All settings you’ve made will be saved and memorized by the system without being
changed due to power failure or power interruption, unless you restore the factory
default settings manually.

4.2 General Settings

4.2.1 Settings the System Time


1. Click the system time area to enter the [UPDATE SYSTEM TIME] menu;
2. Set the system time according to your local time.

4.2.2 Changing System Language


1. Access [MAIN MENU] →[MAINTAIN] and enter the password;
2. Click [LANGUAGE] to select the required system language.

4.2.3 Adjusting Alarm Volume


For specific methods of adjusting alarm volume, please refer to ALARM chapter

4-1
4.2.4 Adjusting Heartbeat Volume
There are two methods of adjusting heartbeat volume:

1. Click [BEAR VOL] on-screen key ;


2. Or access [MAIN MENU] →[SELECTION] →[BEAT VOL];

3. Click or to adjust the heartbeat volume and then click to save the
settings;
4. Available volume levels are 0 to 10. 0 means off and 10 is the maximum volume.

4.2.5 Adjusting Key Volume


There are two methods of adjusting key volume:

1. Click [KEY VOL] on-screen key ;


2. Or access [MAIN MENU]→[SELECTION]→[KEY VOL];

3. Click or to adjust the key volume and then click to save the settings;
4. Available volume levels are 0 to 10. 0 means off and 10 is the maximum volume.

4.2.6 Adjusting Screen Brightness


There are two methods of adjusting screen brightness:
1. Click [LCD LIGHT] on-screen key;
2. Or access [MAIN MENU]→[SELECTION]→[LCD LIGHT];

3. Click or to adjust the screen brightness and then click to save the
settings;
4. Available brightness levels are 1 to 5. 1 is the least brightness and 5 is the brightest.

4.3 Monitor Information


Monitor information is mainly for viewing the software version information operated by the
monitor, so as to facilitate BPLMTPL to maintain and trace the monitor.

Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN MENU],
and click [INFO] to view the software version information.

4.4 Module Setup

1. Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU];
2. Click [MAINTAIN] and enter the password;
3. Click [MODULE SETUP] and click the a certain parameter module to enable or disable its
measurement function

4.5 Demo Function


To enable Demo function:

4-2
1. Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU];
2. Click [DEMO] and enter the password

Warning
 Demo waveform is a kind of simulation of waveforms, which is made by BPLMTPL only
to demonstrate the machine performance and help users to conduct training. In actual
clinical use, the demo function should be disabled, because the medical staff may
mistake it as the monitoring waveforms and parameters of the patient, which affects
monitoring and delays diagnosis and treatment.

4.6 Locking the Touch Screen


To lock the touch screen:

Press [MAIN MENU] on-screen key and hold for more than three seconds until the turns to

, which indicates the touch screen is locked.


To unlock the touch screen:

Press and hold for more than three seconds until it turns to , which indicates the
touch screen is unlocked.

4.7 Network Settings


This monitor can be connected to the central monitoring system via both wired network
and wireless network. The specific methods are as follows:
1. Click the network connection status icon to enter [NETWORK SET] menu;
2. Click [WIFI] to enable or disable the WIFI function. [ON] means connecting to central
monitoring system via wireless network; while [OFF] means connecting to central
monitoring system via wired network;
3. Click [NET BED] to enter the network bed number of this monitor on central monitoring
system. Valid range is 1 to 255;
4. Click [LOCAL IP] to enter the IP address of this monitor, for example, 200.200.200.X. The
valid range of X is 1~255;
5. Click [SERVER IP] to enter the IP address of the central monitoring system. The server IP and
local IP must be in the same network segment.
6. Click [SERVICE PORT] to enter the service port.
7. Click [SUB MASK] to enter the subnet mask of this monitor;
8. Click [GATE WAY] to enter the default gateway corresponding to the local IP;
9. Click [MAC] to enter the MAC address of this monitor;
10. Click [SSID] to enter the SSID of the wireless network. This item is available only when WIFI
function is enabled.
11. Click [MODE] to select [CLIENT] or [SERVER]. [CLIENT] means that this monitor acts as a client
and can be connected with the central monitoring system; while [SERVER] means this
monitor acts as a server and the telemetry monitor produced by BPLMTPL can be
connected with this monitor to view the monitoring information form telemetry monitor.
4-3
This item is available only when WIFI function is enabled.
12. Click [KEY] to enter the password of the router. This item is available only when WIFI
function is enabled.
How to recognize whether the network has been connected successfully:
Icon indicates the network between this monitor and central monitoring system has not been
connected successfully;

Icon indicates the network between this monitor and central monitoring system has been
connected successfully.
Attention
 The network bed number must be unique and cannot be the same as that of any other
monitor connected to the central monitoring system, or it will cause signal deadlock
because of the preemption of the central monitoring system channel.
 If the monitor system halted due to network bed number repetition, remove the
network cable, turn off the monitor and restart. Reset the networks and then reconnect
the network.

4.8 Freezing Waveforms


The users can freeze the displayed waveforms on the screen during patient monitoring and view
the waveforms in detail. Totally 270 second frozen waveforms can be viewed on this monitor.
How to freeze waveforms on the screen:

1. Press the key on the front panel or click [FREEZE] on-screen key;
2. The on-screen key area turns to the figure as below:

3. All displayed waveforms are frozen without being refreshed or scrolling. But the measured
parameter values are refreshed normally.
How to view frozen waveforms:
1. Under frozen waveform status, click [PRE PAGE] or [NEXT PAGE] to view the
frozen waveforms on previous page or next page respectively;
2. Click [FIRST PAGE] or [LAST PAGE] to view the frozen waveforms on the first page or on the
last page respectively;

3. Click [BACK] or press the key to unfreeze the displayed waveforms.


How to record the frozen waveforms:
The frozen waveforms can be output by the recorder. Under frozen status, click [PRINT]
on-screen key or press the print key on front panel, the recorder will start to print the
frozen waveforms and measured parameter values displayed on current screen. When there are
more than 6 channels of waveforms, only the first 6 channels of waveforms will be printed.
Attention
 The function of freezing waveform is not available under ECG mode.

4-4
Chapter 5
Patient Management
5.1 Admitting Patient
Once a patient is connected with the monitor, even if no patient is admitted, the monitor can
also display and store the physiological data of the patient. But it is of great importance to
correctly admit the patient.
To admit a patient:

1. Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU] →[PAT MANAGE];
2. Or click [PAT MANAGE] on-screen key to enter [PAT MANAGE];
3. Click [ADD PATIENT] and prompt message “Are you sure to apply the monitor data to the
new patient?” will be displayed;
4. Select [YES] to merge patient information and admit a new patient; the [PATIENT INFO]
menu will be displayed;
5. Or select [NO] to admit a new patient but the historical data of previous patient will not be
saved; the [PATIENT INFO] menu will be displayed;
6. Enter the patient information in detail and, especially, correctly select patient type and
pacemaker status;
 Click [PAT TYPE] to select the patient type. It is rather important to correctly select the
patient type, which determines the measuring algorithm of calculation and processing
used by the monitor as well as the range of alarm limits.
 Click [PACE] to set it to [ON], when pacemaker signal is detected, it will be indicated by

“ ” above the ECG waveform, and the symbol “ ” will be displayed at the top right

corner of patient type icon; while when it is set to [OFF], there is no information or
symbol displayed.

Warning
 The alarm limit will change with the patient type. Before monitoring a patient, please
make sure the alarm limits are suitable for your patient.
 For patients without pacemaker, you shouldset [PACE] to [OFF]; otherwise, the system
cannot detect arrhythmias associated with ventricular premature beats (including PVCs
count)as well as perform ST segment analysis.
 For patients with pacemaker, you should set [PACE] to [ON]; otherwise, pacing pulse
may be counted into normal QRS waves, causing the alarm “ECG signal is too weak”
cannot be detected.

5-1
Attention
 After discharging the patient, the [PACE] defaults to [OFF].

5.2 Patient Information


The patient information can be edited or changed after a patient has been admitted or when the
patient information is incomplete.

1. Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU] →[PAT MANAGE];
2. Or click [PAT MANAGE] on-screen key to enter [PAT MANAGE];
3. Click [PATIENT INFO] and then edit or change the patient information.

5.3 Discharging Patient


How to discharge a patient:

1. Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU] →[PAT MANAGE];
2. Or click [PAT MANAGE] on-screen key to enter [PAT MANAGE];
3. Select [YES] and the patient will be discharged with patient case stored in historical
data window;
4. Or select [NO] to exit without discharging the patient.

5.4 Data Management


Data management is to help the users to view historical patient data and export historical data.

5.4.1 View Historical Data

Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN MENU]
→[DATA MANAGE] →[HISTORY DATA]. In the historical data window, the following operations
can be performed:
1) Search the historical patient data
Enter the search criteria in the search box and click [QUERY], all the historical data which meet
the search criteria will be displayed in the historical data window.

2) View the historical patient data

 Click or to view the patient information not displayed in the current view;

 Click or to show more historical patient data;


 Select a certain historical data and then click [VIEW], and the [RECALL] menu will be
displayed. What can be viewed about this patient includes patient information, trend history,
NIBP history, alarm history and ECG waveform history.
3) Delete a certain historical data
Select a certain historical data and then click [DEL]. In the pop-up dialog box, select [YES] and
5-2
this historical data will be deleted.
4) Delete all historical data
Click [DEL ALL] and the prompt message “Confirm to delete all case: XX” (XX indicates the
number of total historical data); select [YES] and all the historical data will be deleted.

5.4.2 Export Historical Data


Exporting historical data is to help the users to export historical data saved in the SD card into
the USB flash disk. Exporting historical data requires a very long time and needs to restart the
monitor. Please export historical data when the monitor is not in use.
How to export historical data:
1) Connect the USB flash disk to the monitor

2) Press key on the front panel or click [MAIN MENU] on-screen key to access [MAIN
MENU] →[DATA MANAGE] →[EXPORTING DATA]
3) In the pop-up dialog box, select [YES] to start exporting historical data.

5-3
Chapter 6
User Screens
6.1 Overview
The monitor provides several screens for the user to select, including standard screen,
4-waveform screen, 6-waveform screen, 8-waveform screen, bigfont screen,
trendscreen,oxyCRG screen, list screen, 7-lead screen, 12-lead screen and cascadescreen.User
can get different screen messages from different screens.

6.1.1 Standard Screen


Standard screen can display waveforms of up to 8 channels with separate parameter display
area based on the maximum configuration. The waveform on each channel is not fixedand you
can change the position of each waveform as needed.
To open the standard screen:
(a) Click [SCREENS] on-screen key;
(b) Or access [MAIN MENU] and select [SCREENS]
(c) Select [STANDARD] to open standard screen, as shown below:

Figure 6-1Standard screen

6.1.2 BigFont Screen


Bigfont screen can display four parameters and four waveformswith super-large font, which
facilitates the doctor to observe the monitored value within a certain distance.
To open the big font screen :
(a) Click [SCREENS] on-screen key;
(b) Or access [MAIN MENU] and select [SCREENS]

6-1
(c) Select [BIG FONT] to open big font screen, as shown below:

Figure 6-2Bigfont screen

6.1.3 Trend Screen


What displayed on the trendscreen is the dynamic short tendency chart. From the dynamic short
tendency chart, you can see the recent tendency of each parameter. The label of the tendency is
displayed above each tendency chart, with the scale on the leftand the time below, as shown in
the figure below:

Figure 6-3 HR dynamic short tendency


The position of the dynamic short tendency chart of each parameter is not fixed. You can change
the position of the tendency chart as needed. Take the SpO2 dynamic short tendency for
example, with the steps as follows:
Select the SPO2 dynamic short tendency and select HR in the pop-up list, and then the HR
dynamic short tendency appears at the original position of SpO2 dynamic short tendency.
To open the trend screen:
(a) Click [SCREENS] on-screen key;
(b) Or access [MAIN MENU] and select [SCREENS]
(c) Select [TREND] to open trend screen, as shown below:

6-2
Figure 6-4 Trendscreen
 Position of short tendency chart
Short tendency chart is located at the left of the corresponding waveform in the waveform
area with the same as that of the corresponding parameter and waveform.
 Tendency length
The dynamic tendency length is 2hours, with the right end of the tendency chart being 0h
and the left end being 2h.

6.1.4 OxyCRG Screen


OxyCRG screen displays the oxyCRG chart which is comprised of HR tendency, SPO2 tendency
and RR tendency or compressed respiratory wave and occupies one half of the entire waveform
area.
To open the OXYCRGscreen:
(a) Click [SCREENS] on-screen key;
(b) Or access [MAIN MENU] and select [SCREENS]
(c) Select [OXYCRG] to open the oxyCRG screen, as shown below:

Figure 6-5oxyCRGscreen

6-3
 Select the length of time for OXYCRGchart

Select the oxyCRG chart and one menu [OXYCRG] will be displayed.Select [TIME] and adjust
the length of time among 1 mimute, 2 mimutes and 4 minutes.
 Display compressedrespiratory wave or RR tendency

Select the oxyCRG chart and one menu [OXYCRG] will be displayed. Select [TYPE] and select
[RESP WAVE] or [RR] to display compressed respiratory wave or RR trendency respectively.

6.1.5 List Screen


List screen can display the list of the measured values for parameters. The list occupieshalfof the
entire waveform area. On the list screen, you can review the recently measured data, which is
stored 10groups per page.
To open the list screen:
(a) Click [SCREENS] on-screen key;
(b) Or access [MAIN MENU] and select [SCREENS]
(c) Select [LIST FACE] to open the list screen, as shown below:

Figure 6-6 List screen

6.1.6 Cascade Screen


The cascade screen is to help the users to observe the designated real-time ECG waveforms for a
long time. The cascade screen can display the cascade ECG waveform of II lead on full screen.
The channel number of cascade ECG waveform is the same as that of the waveforms each user
screen can display. For example, under 4-waveformscreen, 4 channels of cascade waveform can
be displayed after clicking [FS CASCADE] on-screen key.
To open the cascade screen:
Click[FS CASCADE] on-screen key to open the cascade screen, as shown below:

6-4
Figure 4-7Cascade screen

6.1.7 Other Screens


4-waveform screen, 6-waveform screen and 8-waveform screen can display the waveforms of 4
channels, 6 channels and 8 channels respectively. The less the number of channels is, the larger
the distributed area of waveform is, and you can observe more clearly.
7-lead screen can display the ECG waveforms of 7 leads, including I, II, III, AVR, AVL, AVF and V,
applicable to the comprehensive observation of ECG waveform when the lead type is 5-lead.
12-lead screen can display the ECG waveforms of 12 leads, including I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5 and V6, applicable to the comprehensive observation of ECG waveform when the
lead type is 12-lead.

6.2 Tailoring Your Screens


You can tailor your monitor’s screen by setting:
 Waveform sweep speed;
 Waveform display style;
 Parameter and waveform display color;
 Waveform exchange;
 Gain.
Here we take ECG as an example.

6.2.1 Changing the Waveform Sweep Speed


(a) Click ECG waveform and the [ECG WAVE] menu will be displayed.
(b) Select [SWEEP].
(c) Select [6.25], [12.5], [25.0s] or [50.0] mm/s.

6-5
6.2.2 Setting the Waveform Display Style
(a) Access [MAIN MENU]→[MAINTAIN] and enter the password;
(b) Select [WAVE TYPE].
(c) Select[LINE], [FILL], [VALEUR]or[BOLD].

6.2.3 Setting the DisplayColor


(a) Click ECG waveform and the [ECG WAVE] menu will be displayed;
(b) Select [WAVE COLOR];
(c) Select [GREEN], [CYAN], [RED], [YELLOW], [WHITE], [BLUE], [PURPLE] or [ORANGE].

6.2.4 Waveform Exchange


(a) Click ECG waveform and the [ECG WAVE] menu will be displayed.
(b) Select [WAVE EXCHANGE].
(c) Select the waveform to be exchanged.

6-6
Chapter 7
Alarm
7.1 Alarm Type
The monitor can give an alarm of two types, physiological alarm and technical alarm.
(1) Physiological alarm
Physiological alarm is usually caused by a certain physiological parameter of the
patient which exceeds the set upper/lower limit scope or by the physiological
abnormality of the patient. The alarm message of the physiological alarm will appear in
the physiological alarm message area.
(2) Technical alarm
The technical alarm is also referred to as a system error message, indicating the alarm is
caused by a misoperation or system malfunction thereby causing improper operation of a
system function or distortion of monitored results. The alarm message of the technical
alarm will appear in the technical alarm message area.
Prompt message is to display the information relative to the system conditions
themselves, which have nothing to do with the patient’s vital sign.Prompt message will appear in
the prompt message area.

7.2 Alarm Level


The monitor can give an alarm in three levels:high, medium and low, based on the severity.
Physiological alarm Technical alarm
Indicate a severe device malfunction
The patient is in a critical or an improper operation, which
condition, endangering the could make it possible that the
High level
patient’s life, emergent monitor cannot detect critical patient
attention required. status and thus threaten the patient’s
life, such as low battery and so forth.
Indicate a device malfunction or an
The patient’s vital signs are
improper operation, which may not
Medium abnormal, relevant measures
threaten the patient’s life but may
level and treatment are
compromise the monitoring of vital
immediately required.
physiological parameters.
The patient’s vital signs are Indicate a device malfunction or an
abnormal and relevant improper operation, which may
Low level compromise a certain monitoring
measures and treatment may
function but will not threaten the
be required. patient’s life.

All alarm levels for technical alarms and some physiological alarms have be set before the
monitors are delivered, and the users are not allowed to change them. But the level of some
7-1
physiological alarms can be modified.

7.3 Alarm Mode


When giving an alarm, the monitor will prompt the users in both audio and visual modes:
 Visualalarm
 Audio Alarm
 Alarm Message
 Parameter’s flashing
In which light signal, audio signal and alarm message are differentiated with those in different
alarm levels.

7.4 Visual Alarm


The alarm lamp will flash at different frequencies and in different colors for different alarm
levels.
 High alarm: flash twice per second in red.
 Medium alarm: flash twice per second in yellow.
 Low alarm: yellow, remaining on.

7.5 Audio Alarm


The audio alarm is to prompt the alarm in different levels of severity with different sounds.
 High level alarm: Do-Do-Do--Do-Do----Do-Do-Do--Do-Do.
 Medium level alarm: Do-Do-Do.
 Low level alarm: Do.

Warning
 Both bedside machines and central monitoring systems have audio alarm function.
 Once the bedside machine is connected to a central monitoring system,although both
the bedside machine and central monitoring system can coordinate the alarm level
as well as the the alarm limit, the bedside machine may not give an alarm
simultaneously when the central monitoring system is giving an alarm due to the alarm
delay function of the bedside machine.
 When alarms of multiple alarm level are triggered simultaneously, the monitor will give
the alarm in audio and visual mode based on alarm level priority.

7.6 Alarm Message


When there is a technical or physiological alarm, you will find a technical or physiological alarm
message in the technical alarm message area or physiological alarm message area respectively.
Physiological alarm messages for different levels of alarms are displayed in different
background colors:
 High level alarm: red
 Medium level alarm: yellow

7-2
 Low level alarm: yellow
Messages for different levels starting with different marks:
 High level alarm: ***
 Medium level alarm: **
 Low level alarm: *
The background color of technical alarm is blue, and the alarm level is low without any mark to
identify the alarm level.

7.7 Alarm Parameter Flashing


When a parameter is alarming, the parameter will flash once every second.The upper alarm limit
or lower alarm limit will also flash in the same frequency indicating the parameter has violated
the upper limit or lower limit repectively.

7.8 Adjusting the Alarm Volume


There are two methods of adjusting alarm volume:

1. Click [ALM VOL] on-screen key ;


2. Or access [MAIN MENU] →[SELECTION] →[ALM VOL];

3. Click or to adjust the alarm volume and then click to save the settings;
4. Available volume levels are 0 to 10. 0 means off and 10 is the maximum volume.

When alarm volume is 0, there will be in the icon area indicating the alarm volume is 0.
The alarm signal sound pressure level from level 0 to level 6 of this monitor is between 45 dB to
85dB.

Warning

 If alarm volume is 0, you will not hear the alarm sound when there is an alarm. Please
set the alarm volume with caution.
 Auditory alarm signal sound pressure levels, which are less than ambient levels, can
impede operator recognition of alarm conditions.

7.9 Alarm Settings

7.9.1 Activating or Deactivating Parameter Alarm Function


Users can manually activate or deactivate the alarm function of a certain parameter. If the alarm
function of a certain parameter is activated, when the measured value of this parameter violates
the alarm limit, the monitor will give an alarm immediately. If the alarm function of a certain
parameter is deactivated, the monitor will not give any alarm.
How to activate or deactivate the parameter alarm function:
7-3
1. Click [LIMIT SET] on-screen key;
2. Or access [MAIN MENU] →[ALARM SETUP] →[LIMIT SET];
3. Click [ALL ALM ON] and the alarm function of all parameters will be activated;
4. Click [ALL ALM OFF] and the alarm function of all parameters will be deactivated;
5. Or click a certain parameter to activate or deactivate its alarm function.

When the alarm function of a certain parameter is deactivated, the icon will appear in
corresponding parameter area.

7.9.2 Setting the Alarm Level


For smart alarm, there is no alarm level option for the user to set and the monitor will give
alarms with corresponding alarm level when the measured values violate the alarm limits set in
that level. For non-smart alarm, the users need to set the alarm level manually. The alarms for
parameter TEMP, RESP, IBP, C.O., and ICG are non-smart alarms.
Here we take TEMP as an example to introduce how to set alarm level:
1 Select ECG parameter area;
2 Select [ALM LEV];
3 Select [HIGH], [MED] or [LOW]

7.9.3 Setting the Alarm Limit

For smart alarm, the users can set the alarm limit of high level, medium level and low level

simultaneously. When the measured value exceeds the normal range, the monitor will auto

judge the alarm limit of which level has been violated and give an alarm with corresponding

alarm level. For non-smart alarm, the user can only set the alarm limit for one alarm level at a

time.

The steps of setting alarm limit for all parameters are the same, and here we take ECG as an

example:

1 Select ECG parameter area, in the pop-up [ECG SETUP] menu, select [LIMIT SET];

2 Or click [LIMIT SET] on-screen key and [LIMIT SET] menu will be displayed, as shown below:

Normal range Alarm Switch

7-4
Parameter

3 Select HR parameter to enter HR alarm limit setup menu, as shown below:

Where, the users can differentiate the alarm level by different colors:
 Red stands for high level;
 Yellow stands for medium level;
 Cyan stands for low level.

4 Select the triangle of each alarm level and click or to adjust the range of alarm
limit.
5 Select to save the alarm limit.

Warning
 Setting alarm limits to extreme values will render the alarm system useless.
 It is very important to set the high limit for HR alarm to an appropriate value. Do not set
it to be 20bpm higher than the patient’s HR.

Attention
 The monitor will always save the alarm settings in case of power interruption and the
alarm settings are restored automatically after power interruption.

7-5
7.9.4 Alarm Recording
The monitor can recording alarm events automatically when the alarms are triggered if the
parameter alarm function and alarm recording function are activated.
How to activate or deactivate the alarm recording function:
1. Access [MAIN MENU] →[ALARM SETUP] →[ALARM REC SETUP];
2. Select [ALL REC ON] and the alarm recording function of all parameters will be activated;
3. Select [ALL REC OFF] and the alarm recording function of all parameters will be deactivated;
4. Or click the separate parameter to activate or deactivate its alarm recording function;
5. Or click the parameter area of a certain parameter, and set [ALM REC] to [ON] in the pop-up
setup menu.
6. When the measured parameter value violates the alarm limit, the monitor will auto
recording the alarm events according to the recording time set in [ALM REC TIME].

7.9.5 Setting the Alarm Delay Time


The alarm system provides five kinds of alarm delay time: [DISABLED], [5SEC], [10SEC], [15SEC]
and [20SEC]. [DISABLED] indicates that the monitor will give alarms immediately once the
measured parameter value violated the alarm limit; [5SEC] indicates the monitor will give alarms
only when the measured parameter value exceeds the alarm limit for continual 5 seconds; and
so forth.
How to set the alarm delay time:
1 Access [MAIN MENU];
2 Press [ALARM SETUP]
3 Press [ALM LATER] to adjust the alarm delay time.

7.10 Pausing alarms

The users can press the key on the front panel or click the [ALM PAUSE] on-screen key to
pause the alarm triggered and put the system into alarm paused status.
1 Stop all the indications of physiological alarms and no new physiological alarm will be
triggered.
2 The remaining pause time “ALM PAUSE xxS” will appear at the physiological alarm
message area.
3 “ALM PAUSE” screen key flashes in red.
4 Technical alarm sound will be paused but alarm message still appears in technical alarm
message area and alarm lamp still flashes. If new technical alarm is triggered during
alarm pause, only the alarm message of this technical alarm will be displayed without
audio and visual alarm indication.
How to set the alarm pause time:
1 Access [MAIN MENU] →[ALARM SETUP];
2 Press [ALM PAUSE TIME] and select the alarm pause time from the pop-up list box.

7.11 Check the Alarm System


How to check the alarm system:
1. Connect the SpO2 cable with the monitor;

7-6
2. Access [MAIN MENU] →[ALARM SETUP] →[LIMIT SETUP];
3. Enable the SpO2 alarm function;
4. Enter SpO2 alarm limit setup menu and set the upper alarm limit of high level to 97 and
lower alarm limit of high level to 90.
5. When the measured SpO2 value exceeds the alarm limits, please observe the audio and
visual alarm and check whether the alarm indications complies with what introduced in this
chapter.
6. Disconnect the SpO2 sensor from the monitor, and you will find the technical alarm
message “SPO2SENSOR OFF” in the technical alarm message area.

7-7
Chapter 8
Battery
8.1 General Introduction
The monitor is equipped with a built-in rechargeable battery which will be auto charged when
the AC power supply is connected no matter whether the monitor is turned on or not. In case of
sudden power failure, the monitor will be auto powered by the battery without operation
interruption and the battery work indicator will be lit up 30s after the power failure.
To understand the battery icon:

: indicating the battery is fully charged;

: indicating the battery charge level is between 75% and 99%;

: indicating the battery charge level is between 50% and 75%;

: indicating the battery charge level is between 25% and 25%;

: indicating the battery charge level is between 1% and 25%;

: indicating no battery installed or damaged battery.

Attention
 Please remove the battery if it will be not be used for a long time and store it properly.
 If a battery is installed in the moitor, the battery must be recharged after each use to
ensure enough battery power.

Warning

 The battery liquid is harmful, In case the liquid contacts your skin or eye, wash it
immediately with large amounts of clean water or seek medical advise.
 Keep the battery out of the reach of children.

8.2 Low Battery Alarm


The monitor will automatically shut down in case of too low battery. When the battery charge
level is less than 3%, the monitor will trigger a technical alarm with alarm message of [BAT.
VOLTAGE LOW]. At this moment, the monitor should be immediately connected to AC supply to
charge the battery, or the monitor will auto shut down before the battery is fully used up.

8.3 Battery Management


In order to better manage the battery, the user can click the battery icon and view the battery
status, battery power and the estimated discharging time.

8-1
(a) Click the battery icon to enter the [BATTERY MANAGEMENT] menu;
(b) View whether the battery is being charged or not;
(c) View the battery power;
(d) View the estimated discharging time.

8.4 Battery Installation


Procedure of installing the battery:
(1) Turn off the monitor, and disconnect the power cord and other cables.
(2) Place the monitor with the back housing at front.
(3) Take down the 12-lead ECG recorder, press the battery lock catch and slide to left with
left hand, and take out the used battery with right hand
(4) Pusha new battert into the battery holder until a click is heard.

Warning

 Use only the supplier’s designated battery.


 Don’t remove the battery while the monitor is turned on.

8.5 Optimization and Check of Battery Performance


(1) Optimization of battery performance
When the battery is used for the first time at least two complete cycles of optimization of
the battery should be carried out. A complete optimization cycle should be:uninterrupted
charging battery until the power is full, followed by use until the battery is fully discharged
and monitor is automatically shut off.
Ensure thesewhen the battery is in optimization process:
(a) Disconnect the monitor from the patient and suspend all monitoring and measuring
procedures.
(b) The optimized battery should be kept in the battery holder of the unit.
(c) When charging the battery, at least six hours of charging should be ensured until it is
fully charged.
(d) When you disconnect the AC power supply, the monitor is powered with the battery
until the battery runs out and the monitor automatically shuts off.
(e) A battery optimization process is done.
(2) Check of battery performance
The service life of battery is changeable along with its storage, working environment charge
cycles and service time. Even though battery is out of service its performance will gradually
deteriorate.
Procedure for checking the battery is as follows:
(a) Confirming whether or not the battery is damaged. When the battery shows the symbol

“ ”, it indicates the battery is damaged or not in the battery holder.

8-2
(b) Checking whether the battery can be normally charged when the battery is connected
to alternating current;
(c) Disconnecting the monitor from the patient and suspending all monitoring and
measuring procedures.
(d) When charging the battery, at least six hours of charging should be ensured until it is
fully charged.
(e) Disconnect the AC power supply, power on the monitor with the battery until it is fully
discharged and the monitor shuts off automatically. Record the start and stop time.
(f) The period of battery discharge will reflect the battery performance.
(g) Once the discharge period is down to 50% of the original time, it requires changing the
battery.

Attention
 In order to extend the service life of the battery it is recommended to charge it every
three months after a long dormant period so as to prevent overdischarge.
 Battery power supply loss depends on the configuration and operation of the monitor;
for example, the unit will have a big loss of battery power if it is used to measure NIBP
parameter often.

8.6 Battery Recycle


If the battery shows apparent damage or low capacity, it should be exchanged immediately, and
the old battery should berecycled and properly disposed of in accordance with relevant laws or
rules and regulations for hospitals .

Warning

 Do not remove the battery or make it short-circuiting or put it into fire; otherwise,
it would cause battery on fire, explosion, harmful gas leakage or other dangers.

8-3
Chapter 9
Review
What can be reviewed on the monitor are the trend graph, trend table, NIBP measurement, alarm
event, ECG waveform and ECG diagnosis report.
The monitor can save 150h trend data, 2,000 groups of NIBP data and 500 parameter alarm
events and 12-lead ECG waveform of 7×12 hours.

9.1 NIBP Measurement Review


This monitor can display the latest 2000 groups of NIBP measurement data in the NIBP
measurement review window.
How to enter NIBP measurement review window:
1. Access [MAIN MENU]→[RECALL];
2. Or click [RECALL] on-screen key;
3. Select [NIBP HIST] to enter the NIBP measurement review window, as shown below:

Figure 9-1 NIBP measurement review window

Data is displayed in the sequence of time from earlier to later. Each screen can display 7groups
of NIBP measurement data. Select or to view the later or earlierdata respectively.
Maximum data of2000 groups can be displayed. But if NIBP measurementdata are more
than2000 groups,the monitor will only save the latest 2000 groups and theearlier ones will be
overwritten. In this window, measured PR data can be review as well.

9-1
9.2 AlarmEvent Review
Review physiological alarm events:
Maximum 500 physiological alarm events can be reviewed in the alarm event review window.
How to enter physiological alarm event review window:
1. Access [MAIN MENU]→[RECALL];
2. Or click [RECALL] on-screen key;
3. Select [ALARM HIST] to enter the physiological alarm event review window, as shown below:

Figure 9-2Physiological alarmevent review window

The following operations can be performed in the physiological alarm event review window:
(1) Set the endtime
Click [END TIME] and set the end time in the pop-up menu. All the physiological alarm events
occurred before the end time will be displayed in this window in chronological order.
(2) Select the alarm event
Click [EVENT] and select the alarm event in the pop-up list box.Available options include [ALL]
andsperate parameter [ECG], [SpO2], [RESP], [NIBP], [TEMP], [CO2],[ARR], [IBP<1,2>],[ICG], [AG] and
[C.O.].
(3) View a certain alarmevent
Select a certain alarm event in this window, for example “***HR TOO LOW” and enter the
review window of this alarm event, as shown below:
Displayed in the menu [ALARM HIST] is the information as follows:

9-2
Figure 9-3 Alarm event review window

What displayed in this window are follows:


 AlarmTime
 Alarm event
 Alarm level
 The waveform and parameter value at the alarm moment
View technical alarm events:
Click technical alarm message area and the [TECHNIC ALARM REVIEW] window will be displayed,
as shown below. All the technical alarm events are shown in this window in chronological order.

Figure 9-4 Technical alarm event review window

9-3
Attention
 When the physiological alarm events in alarm event review window are more than 500,
the status message “ALM SAVE OUT” will be displayed. To delete the physiological
alarm events, the users need to discharge the patient manually.
 When the technical alarm events in technical alarm event review window are more
than 200, the monitor will only store the latest 200 events and the earlier ones will be
overwritten.
 In case of power interruption, the monitor will not maintain the physiological alarm
events but maintain the technical alarm events and the time of powering down is not
captured in the alarm log, neither.

9.3 Trend Review


Trend review consists of trend graph review and trend table review. Users can directly click the
trend graph or trend table label to switch trend review.

9.3.1 Trend GraphReview


The trend graph in the latest 1 hour can be displayed with the resolution of one data every
second or every 5 seconds; and thetrend graph in the latest 150 hours can be displayed with the
resolution of one data every minute, or every 5 or 10 minutes.
How to enter trend graph review window:
1. Access [MAIN MENU]→[RECALL];
2. Or click [RECALL] on-screen key;
3. Select [TREND HIST] to enter the trend graph review window, as shown below:

Figure 9-5Trend graphreview window

9-4
The vertical and horizontal axis respectively represents the measured value and the measuring
time.
The following operations can be performed in the trend graph review window:
1) Set the start time
Click [START AT] and set the start time in the pop-up menu. The trend graph from the start
time will be displayed.
2) Display the trend graph of different parameters
Press the key or to show the trend graph of the parameters not in current view;
Or click any parameter name and select the parameter in the pop-up list box, and the trend
graph of the selected parameter will be displayed.
3) Display 1h or 150h trend graph
Click [RES.], in the pop-up list box, select 1 or 5 seconds to review thetrend graph in the
latestone hour and select 1, 5 or 10 minutes to review thetrend graph in the lastest150
hours.
4) Observethe earlier or latertrend curves
Press or to observe the earlier trend curves or thelater trend curves
respectively.Press or to observe the earliest or latest trend curve respectively.
5) Obtain trend data at a certain moment
Press or to move cursorand the selected moment will change when the cursor moves.
The measured parameter values at the selected moment will be displayed at the right of
the window.

9.3.2 Trendtable Review


The trendtable data in the latest 150 hours can be displayed with the resolution of one data
every minute, every 5minutes, 10minutes, 30minutes or 60minutes.
How to enter trend table review window:
1. Access [MAIN MENU]→[RECALL];
2. Or click [RECALL] on-screen key;
3. Select [TREND HIST] and trend graph review window will be displayed;
4. Select [TREND TABLE] to enter the trend table review window, as shown below:

9-5
Figure 9-6Trendtable review window

The following operations can be performed in the trend table review window:
1) Set the start time
Click [START AT] and set the start time in the pop-up menu, and the trend table data from the
start time will be displayed.
2) Display thetrend tables of different resolutions
Select [RES.] and select the resolution in the pop-up list box. Available resolutions includes
1 minute, 5minutes, 10minutes, 30minutesand 60minutes
3) Displaytrend data of different parameters
Press or to show the trend data of the parameters not in current view.
4) Observe earlier or later trend data
Press or to observe the earlier or later trend data respectively.Press or to
observe the earliest or latest trend data respectively.

9.4 ECG Waveform Review


The monitor can store 12-lead ECG waveforms of 7×24 hours in an 8G SD card.
How to enter ECG waveform review window:
1. Access [MAIN MENU]→[RECALL];
2. Or click [RECALL] on-screen key;
3. Select [ECG HIST] to enter the ECG waveform review window, as shown below:

9-6
Uncompressed
waveform area

Compressed
waveform
area

Figure 9-7 ECG waveform review window

The following operations can be performed in the ECG waveform review window:
1) Set the start time
Click [START AT] and set the start time in the pop-up menu, and the ECG waveform from the
start time will be dispalyed.
2) Change the gain
Select [×1] and select the gain for the uncompressed ECG waveforms.
3) Review the 12-lead waveforms
Select [II] and select the lead name in the pop-up list, and the waveform of the selected
lead will be displayed.
4) Obeserve the amplifiedECG waveform
Click anywhere in the compressed waveform area and the 6-second
amplified waveform will be displayed in theuncompressed waveform area.
5) Observe the earlier or later ECG waveform
Select or to observe earlier or later ECG waveform respectively.
6) Recording ECG waveform
What can be recorded is the12-lead ECG waveform during the selected 6seconds. If applied
ECG lead wire is 3-lead or 5-lead instead of 12-lead, the waveform of other leads will be
baseline.

9.5 Diagnosis Report Review under ECG Mode


The diagnosis report under ECG mode can be viewed, imported, exported and deleted. The
particular operations are as follows:
(1) Under the monitoring mode, click [MON] on-screen key or press Monitoring/ECG mode

9-7
switch key on the front panel to enter the ECG mode;
(2) Click the [DIAG HIST] on-screen key to enter diagnosis report review window, as shown
below:

Figure 9-8 Diagnosis report review window

(3) Click [DEL ALL] to delete all the diagnosis reports;


(4) Click or to show more diagnosis report;
(5) Selecta certain diagnosis report, in the pop-up [DIAGOSTIC INFO HISTORY] menu, users can
click [RECORD] to record this report or click [DEL] to delete it.
(6) When connecting a USB flash disk to the monitor, [REMOVE USB] and [USBCOPY] options will
be displayed in the diagnosis report review window;
(7) Click [USB COPY], select [Copy to USB] and all the diagnosis reports will be exported to the
USB flash disk; or press [Enter USB Case List] to view or delete the diagnosis report in the
USB flash disk.
(8) Click [REMOVE USB] and remove the USB flash disk.

9-8
Chapter 10
Calculation
The calculated results provided by the monitor are calculated from the data you provide, not
representing the measured values of the patient.
The monitor can perform the following calculations:
 Drug calculation
 Hemodynamic calculation
 Ventilation calculation
 Oxygenation calculation
 Renal calculation

Attention
 The calculation function is independent of other monitoring functions. You can
perform the calculation irrelevant to the patient under monitoring without affecting
the patient monitoring.

Warning
 When performing the calculation, please verify that the entered value are correct and
the calculated results are appropriate carefully. We shall not be responsible for any
consequence caused by your incorrect entered value or improper operation.

10.1 Drug Calculation


The monitor provides the calculation for 15 kinds of drugs as well as the titration list display
function.
How to access the drug calculation window:
1. Access [MAIN MENU]→[CALCULATION];
2. Or click [CALCULA] on-screen key;
3. Select [DRUG CAL]and the drug calculation window will be displayed, as shown below:

10-1
Figure 10-1 Drug calculation window

The following formulae are used for drug dosage calculation:


Drug concentration= Total drug amount/ Liquid volume
Infusion rate= Drug dosage / Drug concentration
Duration = Total drug amount/ Drug dosage

10.1.1 Calculation Steps


1. Select [PAT TYPE] and then select the appropriate patient type, including adult, pediatric and
neonate.
2. Select [DRUG NAME] and then select the appropriate drug in the pop-up list, including
Aminophylline, Dobutamine, Dopamine, Epinephrine, Heparin, Isuprel, Lidocaine, Nipride,
Nitroglycerin, Pitocin, Drug A, Drug B, Drug C, Drug D and Drug E, altogether 15 kinds.
3. Select [WEIGHT] and enter the patient’s weight;
4. Enter other values;
5. Each calculation item has its valid range. If the calculated result exceeds the valid range, the
system will display “—”.

Attention
 After entering the patient type, drug name and patient’s weight, the system will give a
set of default values. However, these values cannot be used as the calculated values.
The user must enter values suitable for the patient following the doctor’s instructions.
 Each kind of drug has fixed units or unit series, and operators must select proper unit
following the doctor’s instructions. Under the same unit series, the units will be
automatically adjusted according to the entered values. When the entered values
exceed the valid range, the system will display the valid range.
 The above introduced A, B, C, D and E are not actual drug names. Units for these five
types of drugs are fixed and operators can select proper units based on general

10-2
practice. The expression rules of their units are as follows:
 Drug A, B, and C are fixed under the “mg” unit series including g, mg, and mcg.
 Drug D is fixed under the “unit” unit series including unit, k unit, and m unit.
 Drug E is fixed under the “mEq” unit.

10.1.2 Titration List Display


In the drug calculation window, select [TITRATION] to enter the Titration list window, as shown
below:

Figure 9-2 Titration list window

The following operations can be performed in the titration list window:


(1) In the titration list window, click the [BASIC] to select the reference item, including [DOSE],
[INF RATE] (Infusion rate) and [DRIP RATE].
(2) Click [STEP] and select the step length from 1 to 10.
(3) Click [DOSE] and select the dosage unit [DOSE/min], [DOSE /hr], [DOSE/kg/min] and
[DOSE/kg/hr].

(4) Click or to show more values.

10.2 Hemodynamic Calculation


1. Access [MAIN MENU]→[CALCULATION];
2. Or click [CALCULA] on-screen key;
3. Select [HERMODYNARMIC] and the hemodynamic calculation window will be displayed, as
shown below:

10-3
Figure 10-3 Hemodynamic calculation window

10.2.1 Calculation Steps


(1) Enter values for calculation and click [Calculate] to get the calculated results. If any entered
value exceeds the valid range, the monitor will display the valid range. For invalid
calculated results, the system will display “—”.
(2) Click [RANGE] to view the valid range of the output parameters.

(3) Click or to show the calculated results of the output parameters not in current view

(4) Click [Review] to view the historical calculated results.


Attention
 No calculation result can be obtained if you do not enter any value.

10.2.2 Input Parameters


Abbreviation Unit Full Spelling
HR bpm heart rate
C.O. L/min cardiac output
PAWP mmHg pulmonary artery wedge pressure
Art Mean mmHg artery mean pressure

PA Mean mmHg pulmonary artery mean pressure

CVP mmHg central venous pressure

EDV ml end-diastolic volume

Height cm height

Weight kg weight

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10.2.3 Output Parameters
Abbreviation Unit Full Spelling

C.I. L/min/m2 cardiac index

BSA m2 body surface area

SV ml stroke volume

SI ml/m2 stroke index

SVR DS/cm5 systemic vascular resistance

SVRI DS.m2/cm5 systemic vascular resistance index

PVR DS/cm5 pulmonary vascular resistance

PVRI DS.m2/cm5 pulmonary vascular resistance index

LCW Kg.m left cardiac work

LCWI Kg.m/m2 left cardiac work index

LVSW g.m left ventricular stroke work

LVSWI g.m/m2 left ventricular stroke work index

RVSW g.m right ventricular stroke work

RVSWI g.m/m2 right ventricular stroke work index

EF % ejection fraction

10.3 Ventilation Calculation


1. Access [MAIN MENU]→[CALCULATION];
2. Or click [CALCULA] on-screen key;
3. Select [VENTILATION] and the ventilation calculation window will be displayed, as shown
below:

Figure 9-4 Ventilation calculation window

10-5
10.3.1 Calculation steps
(1) Enter values for calculation and click [Calculate] to get the calculated results. If any entered
value exceeds the valid range, the monitor will display the valid range. For invalid
calculated results, the system will display “—”.
(2) Click [UNIT] and select appropriate pressure unit. Corresponding pressure values will
convert and update automatically.
(3) Click [RANGE] to view the valid range of the output parameters.
(4) Click [Review] to view the historical calculated results.

10.3.2 Input Parameters


Abbreviation Unit Full Spelling

FiO2 % percentage fraction of inspired oxygen

RR rpm respiration rate

PeCO2 mmHg partial pressure of mixed expiratory CO2

PaCO2 mmHg partial pressure of carbon dioxide in the


arteries
PaO2 mmHg partial pressure of oxygen in the arteries

TV ml tidal volume

RQ / respiration quotient

ATMP mmHg atmospheric pressure

10.3.3 Output Parameters

Abbreviation Unit Full Spelling

PAO2 mmHg partial pressure of oxygen in the


alveoli
AaDO2 mmHg alveolar-arterial oxygen difference

Pa/FiO2 mmHg oxygenation ratio

a/AO2 % arterial to alveolar oxygen ratio

MV L/min/m2 minute volume

Vd ml volume of physiological dead space

Vd/Vt % physiologic dead space in percent of


tidal volume
VA L/min alveolar volume

10-6
10.4 Oxygenation Calculation
1. Access [MAIN MENU]→[CALCULATION];
2. Or click [CALCULA] on-screen key;
3. Select [OXYGENATION] and the oxygenation calculation window will be displayed, as shown
below:

Figure 10-5 Oxygenation calculation window

10.4.1 Calculation Steps


(1) Enter values for calculation and click [Calculate] to get the calculated results. If any entered
value exceeds the valid range, the monitor will display the valid range. For invalid
calculated results, the system will display “—”.
(2) Click [HB UNIT], [OXYGEN UNIT] and [UNIT] to change the hemoglobin unit, oxygen unit and
pressure unit respectively. Corresponding parameter values will convert and update
automatically.
(3) Click [RANGE] to view the valid range of the output parameters.
(4) Click [Review] to view the historical calculated results.

10.4.2 Input Parameters


Abbreviation Unit Full Spelling

C.O. L/min cardiac output

FiO2 % percentage fraction of inspired oxygen

PaCO2 mmHg partial pressure of carbon dioxide in the


arteries
PaO2 mmHg partial pressure of oxygen in the arteries

10-7
SaO2 % arterial oxygen saturation

PvO2 mmHg partial pressure of oxygen in venous blood

SvO2 % venous oxygen saturation

Hb g/L hemoglobin

CaO2 ml/L arterial oxygen content

CvO2 ml/L venous oxygen content

VO2 ml/min oxygen consumption

RQ / respiration quotient

ATMP mmHg atmospheric pressure

Height cm height

Weight kg weight

10.4.3 Output Parameters


Abbreviation Unit Full Spelling

BSA m2 body surface area

VO2 calc ml/min oxygen consumption

C(a-v)O2 ml/L arteriovenous oxygen content


difference
O2ER % oxygen extraction ratio

DO2 ml/min oxygen transport

PAO2 mmHg partial pressure of oxygen in the


alveoli
AaDO2 mmHg alveolar-arterial oxygen difference

CCO2 ml/L capillary oxygen content

Qs/Qt % venous admixture

C.O.calc L/min calculated cardiac output

10.5 Renal Calculation


1. Access [MAIN MENU]→[CALCULATION];
2. Or click [CALCULA] on-screen key;
3. Select [RENAL] and the renal calculation window will be displayed, as shown below:

10-8
Figure 9-6 Renal calculation window

10.5.1 Calculation Steps


(1) Enter values for calculation and click [Calculate] to get the calculated results. If any entered
value exceeds the valid range, the monitor will display the valid range. For invalid
calculated results, the system will display “—”.

(2) Click or to show the calculated results of the output parameters not in current view

(3) Click [RANGE] to view the valid range of the output parameters.
(4) Click [Review] to view the historical calculated results.

10.5.2 Input Parameters


Abbreviation Unit Full Spelling

URK mmol/L urine potassium

URNa mmol/L urinary sodium

Urine ml/24h urine

Posm mOsm/kgH2O plasm osmolality

Uosm mOsm/kgH2O urine osmolality

SerNa mmol/L serum sodium

Cr mol/L creatinine

Cr mol/L urine creatinine

UCr mmol/L blood urea nitrogen

10-9
Height cm height

Weight kg weight

10.5.3 Output Parameters


Abbreviation Unit Full Spelling

URNaEx mmol/24h urine sodium excretion


URKEx mmol/24h urine potassium excretion
Na/K % sodium potassium ratio
Can ml/24h clearance of sodium
Clcr ml/min creatinine clearance rate
%
FENa fractional excretion of sodium

Cosm ml/min osmolar clearance


CH2O ml/h free water clearance
U/P osm / urine to plasma osmolality ratio

BUN/Cr mmol/L blood urea nitrogen creatinine ratio

U/Cr / urine-serum creatinine ratio

10-10
Chapter 11
Cleaning and Disinfection
Use only the substances approved by BPLMTPL and methods listed in this chapter to clean or
disinfect your equipment. Warranty does not cover the damage caused by unapproved
substances or methods.
BPLMTPL make no claims regarding the effectiveness of the listed chemicals or methods as a
means for controlling infection. For the method to control infection, please consult the Infection
Control Officer or Epidemiologist in your hospital and also refer to the local policies.

11.1 Overview
Keep your equipment and accessories free of dust and dirt. After cleaning and disinfection,
please check the equipment and if any damage is found, stop use it. To avoid damage to the
equipment, please follow the rules below:
 Always dilute the cleaning agents and disinfectants following BPLMTPL’s instructions
or use the lowest possible concentration.
 Do not allow liquid to enter the enclosure.
 Do not pour liquid onto any part of the equipment or accessories.
 Do not immerse any part of the equipment into liquid;
 Do not use abrasive materials, bleaching powder or erosive cleaners (such as acetone
or acetone-based cleaners).

11.2 Cleaning and Disinfection of the Monitor and Accessories


To avoid cross infection, please clean the monitor and accessories after each use. Please
understand the relevant regulations about equipment cleaning in your hospital before cleaning.
Steps of cleaning:
1. Turn off the monitor,
2. Disconnect the power cord and accessory cable from the monitor;
3. Clean the display screen and the enclosure of the monitor and plug-in modules with a soft
cloth moistened (not wet) with cleaning agents;
4. Clean the accessory cable and sensor with a soft cloth moistened (not wet) with cleaning
agents;
5. After cleaning, wipe off the cleaning agent with a dry soft cloth;
6. Allow the monitor, accessory cable and sensor to air dry.
To avoid damage to the monitor and accessories, disinfection is recommended only when
regulated as necessary in the Hospital Maintenance Schedule. Please wash the monitor and
accessories first before disinfection.
The recommended cleaning agents and disinfectants for the monitor and accessories are listed
in the following table:

11-1
Components Selectable Cleaning Agents Selectable Disinfectants
Isopropyl alcohol(70%), Hydrogen
Isopropyl alcohol(70%),
Monitor peroxide
Glutaraldehyde solution(2%),
enclosure
Sodium hypochlorite

Isopropyl alcohol(70%), Hydrogen Isopropyl alcohol(70%),


Power cord peroxide Glutaraldehyde solution(2%),
Sodium hypochlorite

Isopropyl alcohol(70%), Hydrogen Isopropyl alcohol(70%),


Plug-in module peroxide Glutaraldehyde solution(2%),
Sodium hypochlorite
Alcohol-free soap, Sodium
Isopropyl alcohol(70%),
hypochlorite (with chlorine
ECG cable Glutaraldehyde solution(2%),
bleaching powder and 3% water),
Sodium hypochlorite
Hydrogen peroxide
Alcohol-free soap, Sodium Isopropyl alcohol(70%),
hypochlorite (with chlorine Glutaraldehyde solution(2%),
ECG electrode
bleaching powder and 3% water), Sodium hypochlorite
Hydrogen peroxide

Alcohol-free soap, Sodium Isopropyl alcohol(70%),


Temperature hypochlorite (with chlorine Glutaraldehyde solution(2%),
probe bleaching powder and 3% water), Sodium hypochlorite
Hydrogen peroxide

Isopropyl alcohol (70%) Glutaraldehyde solution(2%),


SpO2 sensor
Sodium hypochlorite

Alcohol-free soap, Sodium Isopropyl alcohol(70%),


hypochlorite (with chlorine Glutaraldehyde solution(2%),
IBP cable
bleaching powder and 3% water), Sodium hypochlorite
Hydrogen peroxide

Alcohol-free soap, Sodium Isopropyl alcohol(70%),


hypochlorite (with chlorine Glutaraldehyde solution(2%),
ICG cable
bleaching powder and 3% water), Sodium hypochlorite
Hydrogen peroxide

Alcohol-free soap, Sodium Isopropyl alcohol(70%),


hypochlorite (with chlorine Glutaraldehyde solution(2%),
C.O. cable
bleaching powder and 3% water), Sodium hypochlorite
Hydrogen peroxide

Mainstream CO2 Ethanol (70%), Isopropyl alcohol Glutaraldehyde solution(2%),


module (70%) Sodium hypochlorite

Sidestream CO2 Ethanol (70%), Isopropyl alcohol Glutaraldehyde solution(2%),


module (70%) Sodium hypochlorite

Ethanol (70%), Isopropyl alcohol Glutaraldehyde solution(2%),


AG analyzer
(70%) Sodium hypochlorite

11-2
Warning
 Do not use the cleaning agents and disinfectants other than those recommended in this
user manual, because permanent damage to the monitor or accessories may occur, or
safety hazards may be caused.
 Before cleaning the monitor, make sure that it is switched off and disconnected from AC
power.
 Never use acetone on any part of the monitor.
 Never pour or spray liquid on the monitor.
 Use a cloth to wipe off any cleaning agent remaining on the monitor or accessories.
 Do not mix the cleaning agents, or dangerous gas will be produced.
 Do not clean or disinfect the disposable accessories. Do not reuse the disposable
accessories to avoid cross infection.
 To protect environment, the disposable accessories must be disposed of properly
according to local regulations and requirements.
 After cleaning, inspect the sensor cable for damage or aging. If any damage or aging is
found, please replace the sensor cable.
 Do not sterilize the monitor and accessories by autoclave.
 Do not use ETO gas to disinfect the monitor or accessories.
 Do not immerse the sensor or connector into any cleaning agent or disinfectant.
 To prevent cleaning liquids and dust from entering the ISA analyzer through its LEGI
connector, keep the Nomoline Family sampling line connected while cleaning the
analyzer. Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 The Nomoline sampling lines are non-sterile devices. To avoid damage, do not autoclave
any part of the sampling line.
 Remove the disposable IRMA airway adapter prior to cleaning the IRMA probe. Never
sterilize or immerse the IRMA probe in liquid
 The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not
autoclave the devices as this will damage them.

Caution
 If you accidently pour liquid onto the monitor or accessories, please contact the customer
service immediately.

11.3 Cleaning and Disinfection of the Cuff


Take out the rubber bag before cleaning the cuff.
The cuff can be hand washed or machine washed in warm water or with mild detergent.
Hand wash can extend the service life of the cuff. Air dries the cuff after cleaning.
The cuff may be disinfected with a cloth moistened with 70% ethanol or 70% isopropanol.
Prolonged use of disinfectant may cause discoloration of the cuff.

11-3
Warning
 Don’t compress the rubber pipe on a cuff.
 Do not allow the liquid to enter the rubber bag when cleaning it.
 Do not dry clean the cuff.
 The disposable cuff must be disposed of according to the local laws and regulations.
After cleaning, put the rubber bag into the cuff as following steps:
1 Place the rubber bag on the top of the cuff.
2 Roll the rubber bag lengthwise and insert it into the large opening;
3 Hold the hose and the cuff and shake the complete cuff until the rubber is in position.
4 Thread the hose from inside the cuff and out through the small hole under the internal flap,
as shown below:

11-4
Chapter 12
Maintenance
12.1 Maintenance Check
The overall check of the monitor, including a safety check, should be performed only by
qualified personnel before first use, every 6 to 12 month, and each time after repair.
Before using the monitor, do the following:
(a) Check if the work environment and power supply meet the requirements.
(b) Check if there is any mechanical damage.
(c) Check if the cables are worn and ensure insulation is in good condition.
(d) Check all the functions of the monitor to make sure that the monitor is in good condition.
(e) Check if the accessories used are specified by BPLMTPL.
(f) Check the battery.
(g) If the monitor is equipped with a recorder (optional), please check if the recorder is
normal and recording paper meets the specified specification.
(h) Check if the wiring resistance and leakage current meet the requirements.
If you find any damage on the monitor, stop using the monitor on patient,and contact the
biomedical engineer of the hospital or our customer service immediately.
All the safety and maintenance checks that need to dismantle the monitor should be performed
by a qualified customer service technician. Non-professional operation can cause the monitor
damage or cause a security risk, and human health may be endangered.
The circuit diagrams of the monitor can be provided by BPLMTPL as per customer demands.
Qualified technicians can use it to help the user repair some apparatus that BPLMTPL classifies
as “can be maintained by the user”.

Warning
 If the hospital or agency that is responsible for using the monitor does not follow a
satisfactory maintenance schedule, the monitor may become damaged, and human
health may be endangered.

12.2 Maintenance Schedule


The following safety and maintenance check can be conducted by professional persons
approved by BPLMTPL. You can contact the customer service technicians if you need the
following maintenance. Before the inspection or maintenance, the facilities should be cleaned
and disinfected.

12-1
Check and maintenance items Frequency

Safety check according to IEC At least once a year. Or after monitor falling, power
60601-1 requirements replacement, or as required.

Defibrator synchronization function At least once a year or as required.

NIBP air leakage test At least once a year or as required.

NIBP calibration

ECG calibration
At least once a year or when you doubt the measured
IBP calibration value.
The performance of all measuring
functions

At least once a year or after changing the touch


Touch screen calibration
screen.

Battery See the section on battery for reference

12.3 ECG calibration


During the use of monitor, ECG calibration is required when the ECG signal is inaccurate. ECG
calibration should be conducted by the serviceman approved by BPLMTPL at least once a year
or when you doubt the measured value. Specific steps are as follows:
1. Press ECG parameter area;
2. Press [ECG CAL]. Then the screen displays square wave signal and displays prompt message
“ECG CALIBRATING….”
3. Compare the amplitude of the square wave with the wave scale. The difference should
be within 5%.
4. After calibrating, press [STOP CAL].

12.4 NIBP Air Leakage Test


It is used to check if the NIBP measuring pump has a leak. If the leakage test is passed, the
system will not give any prompt; if not, there will be a corresponding error message in the NIBP
parameter area.NIBP air leakage test should be conducted by the serviceman approved by
BPLMTPL at least once a year or when you doubt the measured value.
Leakage test process:
(1) Connect the cuff to the NIBP socket on the monitor.
(2) Wrap the cuff around a cylinder with proper size, as the figure shows.

Cylinder
Patient
Monitoring

NIBP Pressure line


Cuff
12-2
(3) Enter [NIBP SETUP] menu.
(4) Select [PNEUMATIC] and the monitor starts to perform NIBP air leakage test with
“PNEUM TESTING…” status message displayedin the NIBP parameters area.
(5) System automatically inflates to the pressure of 180mmHg.
(6) After about 20 seconds, the system will automatically open the valve, which means
leakage measurement is complete.
(7) If there is no error message in the NIBP parameter area, it means that the system has no
sign of air leakage. If error message “Pump Leaking…” is displayed, it means that the air
circuit may have an air leakage fault. Under such a circumstance, the operator should
check the entire connection for loosening, and run the leakage test again after having
made sure that the connection is errorless.
(8) If the error message still appears, please contact BPLMTPL for repair.

Warning
 This air leakage test, different from those described in the standard EN 1060-1, is for
users to simply test air leakage in NIBP inflation. If the system displays an error message
“Pump Leaking…” at the end of testing, please contact the BPLMTPL maintenance
engineers.

12.5 NIBP Pressure Calibration


NIBP pressure calibration should be carried out once a year or when you doubt the measured
NIBP by the serviceman approved by BPLMTPL.

Manufacturers recommend a calibrated pressure gauge (or mercury sphygmomanometers) with a


precision more than 1mmHg to be used for calibration. Select "calibration" to begin calibration
and this item becomes "stop calibration", if you press the knob right now, the system will stop
the calibration.

Pressure sensor calibration steps:

Metal containers with a volume of 500ml ± 5% instead of cuffs. Connect a calibrated standard
gauge with measurement error of less than 0.8mmHg, a spherical air pumps with a t-interface
and inflatable tubes attached to NIBP jack on the module. Set the monitor to "calibration" mode,
and then inflate the metal containers with ball type air pump to pressure of 0,50 and 200 mmHg
respectively. The difference of pressure value between standard pressure gauge and monitor
should be within the 3mmHg. Otherwise, please contact the BPLMTPL maintenance engineers.

12-3
Patient Standard pressure
Monitoring meter
NIBP
Gas pipe

Round pump Metal vessel

12.6 IBP Calibration


IBP calibration can only be performed by BPLMTPL at least once a year or as required. When IBP

calibration is needed, please contact BPLMTPL.

12.7 Touch Screen Calibration


Touch screen calibration should be conducted at least once a year or when the touch screen is

insensitive or after changing the touch screen. Calibration methods are as follows:

1 Access [MAIN MENU].

2 Press [MAINTAIN] and enter the password.

3 Press [SCR ADJUST].

4 Press the five symbols one by one following the indication on the screen

5 After calibration, the system will return to main screen automatically.

12-4
Chapter 13
Patient Safety
13.1 Safety Instruction
The design of the monitor complies with the international safety standard regarding medical

electrical equipment. The monitorhasthe functions of defibrillation protection with floating

input and surgical electrotome protection. Use the correct electrodes and place them according
to the guidance of BPLMTPL, and the display will resume 10 seconds after defibrillation.

13.2 Environment
The following guidance should be followed to ensure the safety of electrical installations.
Vibration, dust, corrosives or explosive gas, extreme temperature and humidity should be
avoided at the place where the monitor is used.
If the monitor is installed in a cabinet, enough space in front and behind should be left for
convenient operation, maintenance and repair. The monitor should be at least 2 inches or 5
centimeters away from around the cabinet for good ventilation.
The monitoring system should be in the ambient temperature -20℃~+55℃ (storage), 5℃~
40℃(running) to satisfythe requirements.An ambient environment out of this range may impair
the instruments accuracy and cause damages to its components and circuits.

13.3 Grounding Protection


To protect the patients and operator, the enclosureof themonitor must be grounded. The monitor
is equipped witha removable three-wire cable. When the cable plugs in a matching plug
connector, the grounding wire of the power line ground the monitor. In case a three-plug
connector is not available, the electrical operating staff should be consulted.

Warning
 Replacement of the three-plug connector with a two-plug connector is strictly
prohibited.

The grounding wire should be connected with the equipotential grounding terminal of the
instrument. The instrument users who do not know whether a given combination of instruments
may invite dangers, e.g. due to accumulations of leaked currents should consult relevant
manufactures or experts in this field so as to guarantee that the required safety of the combined
instruments are not compromised when the given combination is in use.

13.4 Equipotential Grounding


The primary protection of the instrument is embodied in the building protective grounding
(protective ground) system by means of power plugs grounding. The multi-parameter monitor
should be separately connected with the equipotential grounding system for examinations of
13-1
hearts or skulls. One end of the equipotential grounding wire (potential equalization conductor)
should be connected onto the equipotential grounding terminals on the rear panel of the
instrument and the other should be connected onto one connector of the equipotential system.
The equipotential grounding system should be in place for safety functions of the protective
grounding wire in case of any damage to the protective grounding system. Cardiac or brain
examinations should be conducted only in the rooms equipped with protective grounding
systems. A check of the instruments should be conducted to guarantee the instruments are in
good repair before each examination. The cables connecting with patients and instruments
should be guaranteed not having been subjected to electrolytic pollution.

Warning
 Battery power should be used to power the monitor against unstable protective
grounding system.

13.5 Condensation
The working instruments should be guaranteed not to form any condensation. Transferring of

the instrument from one room to another may cause condensation on the instrument. This is

attributed to its exposure to humid air at different temperatures. Unnecessary problems can be

avoided by placing the instrument in a dry place before putting it into use.

Note: Condensation is defined as coagulation of gases or liquids when cooled, e.g. water

vapor when cooled is transformed into water and water when cooled into ice. The lower the

temperature is, the faster condensation is formed.

Warning
 The monitor is prohibited to use in the presence of combustible anesthetics so as to avoid
any risk of explosions.

13-2
Chapter 14
Recording (optional)
The monitor is equipped with a recorder for printing 12-lead ECG waveforms and ECG analysis
reports (optional).

Roll paper

Fastening device for


Roll paper

Recorder door

Figure 14-1 Side view of recorder with open recorder door

14.1 Recorder Installation


To install the recorder, hold the recorder with both hands and push it until a click is heard.
To remove the recorder, press the recorder catch lock and pull the recorder rightwards at the
same time.

14.2 Loading Record Paper


(1) Press the recorder latch and open the recorder cover gently;
(2) Take out the roll paper;
(3) Put the new roll paper into the fastening device and make sure that the roll paper can twirl
smoothly. Please note that grid side of the paper should face above;
(4) Pull the record paper out of the paper exit for about 2cm and, at the same time, close the
recorder door until a click is heard.
(5) Check if the record paper is loaded correctly and the record paper is feeding normally.

14.3 Printing
This monitor supports printing under monitoring mode and manual, auto and rhythm printing
under ECG mode. What printed under monitoring mode is the waveform and measured value of
multiple parameters, while what printed under ECG mode is 12-lead ECG waveform and analysis
report.

14.3.1 Printing under Monitoring Mode


Printing under monitoring mode is also called alarm recording. When certain parameter triggers
an alarm and its alarm recording function is enabled, the monitor would automatically print
the waveforms and measured values according to the settings in [EXPORT SETUP] menu.
Or just press the print key to print the waveform or measured value as needed.
14-1
14.3.2 Manual Printing under ECG Mode
Under the manual printing mode, the users need to select leads to print manually and the
monitor will not conduct ECG analysis but print directly.
Steps of manual printing:
(1) Under the monitoring mode, click the [MON] on-screen key or press monitoring/ECG mode

switch key to enter the ECG mode;


(2) Click [MANUAL] on-screen key to enter the manual printing interface;
(3) Click anywhere in the waveform area, in the pop-up [ECG SETUP] menu, adjust the channel
format, filter, waveform sweep speed and waveform gain, if necessary;
(4) Click [LEAD] on-screen key to select the leads to print. [LEAD] on-screen key is
unavailable when the channel format is 12×1;
(5) Click [RECORD] on-screen key or press the print key on the front panel and the printing
begins.

Figure 14-2 Manual printing under ECG mode (3×4+3R)

14.3.2.1 Auto Printing under ECG Mode

What can be printed under the auto printing mode are 12-lead ECG waveforms, ECG analysis
report and ECG average template.
Steps of auto printing:
(1) Under the monitoring mode, click the [MON] on-screen key or press monitoring/ECG mode

switch key to enter the ECG mode;


(2) Click [AUTO] on-screen key to enter the auto printing interface;
(3) Click anywhere in the waveform area, in the pop-up [ECG SETUP] menu, adjust the channel
14-2
format, waveform sweep speed and waveform gain, if necessary;
(4) Access [EXPORT SETUP] menu and set the [REPORT TEXT], [AVERAGE TEMPLATE] and [SAVE
OPTION] according to the needs;
(5) Click [ANALYSIS] on-screen key and the monitor starts to sample the ECG with status
message “Sampling 10s” displayed. After sampling, the monitor starts to analyze the
sampled ECG with status message “Analysis” displayed. After analysis, the [DIAG
REPORT] window will be displayed.
(6) Click [RECORD] on-screen key or press the print key on the front panel, and the printing
begins.

Figure 14-3 Auto printing under ECG mode

14.3.3 Rhythm Printing under ECG Mode


Under the rhythm printing mode, the monitor will print rhythm waveforms of three channels, 60s
for each channel, but will not conduct ECG analysis.
Steps of rhythm printing:
(1) Under the monitoring mode, click the [MON] on-screen key or press monitoring/ECG mode

switch key to enter the ECG mode;


(2) Click [RHYTHM] on-screen key to enter the rhythm printing interface;
(3) Click anywhere in the waveform area, in the pop-up [ECG SETUP] menu, select three rhythm
leads and adjust the filter, waveform sweep speed and waveform gain, if necessary;
(4) Click [RECORD] on-screen key or press the print key on the front panel, and the printing
begins.

14-3
Figure 14-4 Rhythm printing under ECG mode

14.3.4 VCG Printing under ECG Mode


Under the VCG printing mode, both the ECG waveform and VCG can be printed simultaneously.
Steps of VCG printing:
(1) Under the monitoring mode, click the [MON] on-screen key or press monitoring/ECG mode

switch key to enter the ECG mode;


(2) Click [VCG] on-screen key r to enter the VCG printing interface;
(3) Click anywhere in the waveform area, in the pop-up [ECG SETUP] menu, adjusting the
filter, waveform sweep speed and so on, if necessary;
(4) Click [ANALYSIS] on-screen key and the monitor starts to sample the ECG with status
message “Sampling 10s” displayed. After sampling, the monitor starts to analyze the
sampled ECG with status message “Analysis” displayed. After analysis, the [DIAG
REPORT] window will be displayed.
(5) Click [RECORD] on-screen key or press the print key on the front panel, and the printing
begins.

14-4
Figure 14-5 VCG printing under ECG mode

14.4 Print Settings

14.4.1 Print Settings under Monitoring Mode


Access [MAIN MENU], select [RECODER SET] and the recording setup menu will be displayed.
 Click [REC RATE] to adjust the recording speed. Available options include 12.5mm/s,
25mm/s and 50mm/s;
 Click [PRINTER SELECT] to choose the printer.
 [Inter.] means using the recorder equipped with the monitor to print;
 [Exter.] means using the external printer to print;
 [CLOSE] means no printing.
 Click [EXPORT SETUP] to select the waveforms to print and adjust the recording time.
 Waveforms of maximum 6 channels can be printed by this monitor. Click [REC
WAVE1], [REC WAVE2], [REC WAVE3], [RECORD WAVE4], [RECORD WAVE5] and
[RECORD WAVE6] respectively and select the waveform in the pop-up list box.
Available waveforms include I, II, III, aVR, aVL, aVF, V, RESP, PLETH, CO2, CH1:ART,
CH2:PA, CO2(AG), N2O, O2, AA and off. Off means no waveform to be printed.
 Click [RT REC TIME] to select the real-time recording time. Available options include
[3S], [5S], [8S] and [CONTINUAL]. [CONTINUAL] means the recorder will print
the waveforms and measured parameter value continually after pressing the
print key and press the print key again to stop printing.

14.4.2 Printing Settings under ECG Mode


Under the monitoring mode, click the [MON] on-screen key or press monitoring/ECG mode

switch key to enter the ECG mode. Click anywhere in the waveform area and the [ECG
SETUP] menu will be displayed.
 Click [CHANNEL FORMAT] to change the channel format. Available options include 12×1,
6×2, 6×2+1R, 3×4,3×4+1R and 3×4+3R. This item is unavailable under rhythm printing
mode.
a) [12×1] means the 12-lead ECG waveforms are recorded in one column and 12 channels,
recording 10 seconds all together.
b) [6×2] means the 12-lead ECG waveforms are recorded in 2 columns and 6 channels,
recording 5 seconds in each column;
c) [6×2+1R] means the 12-lead ECG waveforms are recorded in 2 columns and 6 channels,
recording 5 seconds in each column and adding one channel rhythm lead waveform;
d) [3×4] means the 12-lead ECG waveforms are recorded in 4 columns and 3 channels,
recording 2.5 seconds in each column;
e) [3×4+1R] means the 12-lead ECG waveforms are recorded in 4 columns and 3 channels,
14-5
recording 2.5 seconds in each column and adding one channel rhythm lead waveform;
f) [3×4+3R] means the 12-lead ECG waveforms are recorded in 4 columns and 3 channels,
recording 2.5 seconds in each column and adding three channel rhythm lead waveform;
 Click [RHYTHM LEAD1], [RHYTHM LEAD2] and [RHYTHM LEAD3] and select a rhythm
lead waveform for each item. Available options include I, II, III, aVR, aVL, aVF, V1, V2, V3,
V4, V5 and V6.
 Click [FILTER] to enable or disable the filter function.
a) When the filter function is enabled, the monitor will conduct AC filtering, EMG
filtering, lowpass filtering and drift filtering. The users can access [MAINTAIN] menu
and set the [AC FILTER], [EMG FILTER], [LOWPASS FILTER] and [DFT FILTER], if
necessary.
b) When the filter function is disabled, the monitor will only conduct AC filtering.
c) The users can also click the [FILTER]/ [NORMAL] to enable or disable the filter
function respectively.
 Click [SWEEP] to adjust the waveform sweep speed. Available options include 12.5mm/s,
25mm/s and 50mm/s.
 Click [GAIN] to adjust the waveform gain. Available options include 2.5mm/mV, 5mm/mV,
10mm/mV and 20mm/mV.
 Access [EXPROT SETUP] menu and conduct the following settings:
a) Click [REPORT TEXT] to set what will be printed in the analysis report.(Only available
under auto printing mode);
 [CLOSE] means what will be printed in the analysis report is only the patient
information set in [PATIENT INFO] menu;
 [BASIC] means what will be printed in the analysis report include the patient
information set in [PATIENT INFO] menu, interval, electric axis, amplitude and so on;
 [DETAILED] means what will be printed in the analysis report include the patient
information set in [PATIENT INFO] menu, interval, electric axis, amplitude,
Minnesota code, diagnosis information and so on.
b) Click [AVE TEMPLATE] to set the format for the ECG average template, (only available
under auto printing mode) ;
 [3×4+1R] means the average template 12-lead ECG waveform are recorded in 4
columns and 3 channels with one channel rhythm lead waveform;
 [6×2+1R] means the average template 12-lead ECG waveform are recorded in 2
columns and 6 channels with one channel rhythm lead waveform;
 [CLOSE] means no average template will be printed.
c) Click [SAVE OPTION] to set whether save the ECG waveform printed under auto
printing and VCG printing mode,(only available under auto printing and VCG printing

14-6
mode);

 [ON] means the printed ECG waveform under auto printing and VCG printing
mode will be saved in [DIAG HIST] window;
 [OFF] means printed ECG waveform under auto printing and VCG printing mode will
not be saved;

Attention
 The external printer is optional.
 Only use the external printer designated by BPLMTPL. Other external printers may not
be recognized or may damage the monitor or influence the performance and safety of
the monitor. So far, external printers supported by this monitor are Lenovo LJ2250N, HP
P2015D and HP P2055D.

14-7
Chapter 15
ECG Monitoring
15.1 Overview
The ECG measures the electrical activity of the patients’ heart and displays it on the monitor in
the form of waveform and values as to accurately assess the physiological status of the patient.
To get accurate measured value, the ECG lead wired should be placed correctly.
This monitor is applicable to 3-lead, 5-lead and 12-lead ECG monitoring. Different waveforms
can be displayed according to different lead wires.

15.2 ECG Display


2 3 4 5

1
6
8
7

Figure 15-1 ECG display

Attention
 The pacing signal detected will be shown as “ ”above the ECG waveform

1. ECG lead name


2. Waveform gain
3. Filter mode
4. 1 mV scale
5. The alarm limits
6. PVCs and ST segment analysis
Display the current status of PVCs and ST-Isegment analysis with the refresh rate of one
second.
7. ECG measured value
8. ECG Wave form

15-1
15.3 Safety Information
Warning
 The operators shall not touch the patients, tables and instruments during defibrillation.
 Only use the ECG lead wire designated by BPLMTPL.
 When connecting the electrodes or patient cable, make sure that the conductive parts of
electrodes and associated connectors for applied parts, including the neutral electrode,
should not contact any other conductive parts including earth and make sure that all the
electrodes are placed on the patient to prevent them from contacting the conductive
parts or earth.
 Inspect the electrode application site for skin irritation daily. If there is sign of allergy,
Replace the electrodes or change the application site.
 Before ECG monitoring, check that the function of ECG cable is normal. After
disconnecting the ECG cable, the monitor will trigger an audible alarm and display alarm
message "SENSOR OFF".

Attention
 Interference from ungrounded equipment near the patient and ESU interference may
cause waveform problems. If you operate under the conditions regulated by
EN60601-1-2 (with the anti-radiation capacity of 3V/m), the electric field strength more
than 1V/m may cause measurement errors at various frequencies. Therefore, it is
recommended not to use electrical radiation equipment near the ECG / respiration
monitoring devices.
 If ECG electrodesareplaced correctly,but the ECG waveform is not accurate, please
replace the lead wires.
 In order to protect the environment, the electrodes used should be recycled or be
disposed of properly.

15.4 Steps of Monitoring


15.4.1 Preparation
Make corresponding preparation for patient’s skin before connecting electrodes:
(a) As skin is poor conductor of electricity, to get a good contact of the electrode and the skin, it
is important to make preparation for the patient s' skin.
(b) If necessary, shave the area for the electrode.
(c) Thoroughly clean the skin with soap and water. (Do not use ether or pure alcohol, because
they will increase the resistance of the skin).
(d) Dry and rub the skin in order to increase the capillary blood flow and remove skin debris
and oil.
(e) Attach the alligator clip prior to placement of the electrode.
(f) Place electrodes on the patient. If the electrodes used do not have conductive gel, apply the
conductive gel before placement.
15-2
(g) Connect the electrode lead and the patient cable.

15.4.2 Placement of ECG Electrodes

15.4.2.1 Identifiers and Color Code of Electrodes

The table below shows the lead names in the European and American standards. (The leads are
represented by RA, LA, RL, LL, and V in the American standard, while by R, L, N, F, and C in the
European standard.):
Identifier and color code of 3-lead and 5-lead electrodes are as follows:
American standard European standard
Name of lead Color Name of lead Color
RA White R Red
LA Black L Yellow
LL Red F Green
RL Green N Black
V brown C White

Identifier and color code of 12-lead electrodes are as follows:


American standard European standard

Lead Position Marking Color Marking Color

right arm RA white R red

left arm LA Black L yellow

right foot RL green N or RF Black

left foot LL red (f) green

chest 1 V1 red C1 red

chest 2 V2 yellow C2 yellow

chest 3 V3 green C3 green

chest 4 V4 blue C4 Brown

chest 5 V5 orange C5 Black

chest 6 V6 purple C6 purple

15.4.2.2 Placement of 3-lead ECG Electrodes


The position of electrode of 3-lead ECG cable is divided into American standard and European
standard see the figure below):
White/red (right arm) electrodes - placed under the clavicle, near the right shoulder.
Black/yellow (left arm) electrodes - placed under the clavicle, near the left shoulder.

15-3
Red/green (left leg) electrodes - placed in the left lower abdomen.

Figure15-2Positions of electrodes of 3-lead ECG cable

15.4.2.3 Placement of 5-lead ECG Electrodes

The position of electrode of 5-lead ECG cable is divided into American standard and European
standard (see the figure below):
White/red (right arm) electrodes - placed under the clavicle, near the right shoulder.
Black/yellow (left arm) electrodes - placed under the clavicle, near the left shoulder.
Green/black (right leg) electrodes – placed at the right lower quadrant.
Red/green (left leg) electrodes - placed in the left lower abdomen.
Brown/white (chest) electrode- on the chest wall

Figure15-3Positions of electrodes of 5-lead ECG cable

15-4
15.4.2.4 Placement of Reformed 12-lead ECG Electrodes

The position of electrode of 12-lead ECG cable is divided into American standard and European
standard (see the figure below).
White/red (right arm) electrodes - placed under the clavicle, near the right shoulder.
Black/yellow (left arm) electrodes - placed under the clavicle, near the left shoulder.
Green/black (right leg) electrodes – placed at the right lower abdomen.
Red/green (left leg) electrodes - placed in the left lower abdomen.

Figure 15-4Positions of limb electrodes of 12-lead ECG cable

There are generally six electrode positions on the chest, using intercostal gap to pinpoint the
positions, V1 ~ V6:
V1/C1: in the fourth intercostal space on the right edge of the sternum
V2/C2: in the fourth intercostal space on the left edge of the sternum
V3/C3: at the midpoint of the C2 and C4
V4/C4: at the intersection of the fifth intercostal space on the left edge of the sternum and the
midline of left clavicular
V5/C5: at the left anterior axillary line, with horizontal position the same as the C4
V6/C6: at the parallel median axillary line of C4 level on the left at the left median axillary
line, with horizontal position the same as the C4

15-5
Figure 15-5 Position of chest electrodes of 12-lead ECG cable

15.4.2.5 ECG Lead Connection Recommended for Surgical Patients

Warning
 When using electricity surgical unit (ESU), put the ECG electrode at the middle position
between ESU earth plate and electrosurgical knife to avoid burn. The cable of
electricity surgical unit and the ECG cable can't be entangled.
 In the use of electricity surgical unit (ESU), never allow the electrodes to be close to the
earth plate of electricity surgical unit, or ECG signal would be interfered seriously.

The position of ECG lead depends on the type of surgery. For example, for the thoracotomy,
electrode can be put on the chest or the back. In the operating room, because of using
electrosurgical knife equipment, sometimes artifact may affect ECG waveform, in order to cut
the artifact, you can put the electrode on left and right shoulder, near the abdomen of left or
right side, and the breast lead can be put on the left side of chest quiet near the center. To avoid
the electrode being put on the upper arm, or ECG wave will become very small.

15.5 Waveform Quality


Users can choose to display the ECG waveform with the best signal.
Feature of a good signal:
 Tall, narrow and without notch.
 R wave tall, completely above or below the baseline.
 T waves less than 1/3 height of R wave.
 P wave should be much smaller than T wave
In order to obtain 1 mV calibration ECG waveform, ECG calibration should be conducted. During
ECG calibration, the screen displays the status message “CAL, CAN’T MONITOR!” (Cannot monitor
15-6
the patient during calibration).

Figure 15-6 Standard ECG waveform

15.6 ECG Settings

15.6.1 Setting the Lead Type


This monitor is applicable to the 3-lead, 5-lead and 12-lead ECG monitoring. When ECG cables of
different leads are used, the ECG leads that can be monitored is different.
When using 3-lead ECG lead wire, the leads can be monitored include I, II and III.
When using 5-lead ECG lead wire, the leads can be monitored include I, II, III, aVR, aVL, aVF and V.
When using 12-lead ECG lead wire, the leads can be monitored include I, II, III, aVR, aVL, aVF, V1
and V2, and V3, V4, V5and V6.
When using the 3-lead ECG lead wire, only one channel ECG waveform can be displayed on the
screen; while when using the 5-lead or 12-lead ECG lead wire, ECG waveforms of three channels
can be displayed on the screen.
Steps for setting the lead type:
(a) Click ECG parameter and [ECG SETUP] menu will be displayed;
(b) Set the [LEAD TYPE] to [3 LEADS], [5 LEADS] or [12 LEADS].

15.6.2 Setting the Lead Name


(a) Click ECG waveform and [ECG WAVE] menu will be displayed;
(b) Click [LEAD NAME] and select the lead name from the pop-up list box, for example, lead II.

15.6.3 Setting the Gain


Gain is used to adjust the size of ECG waveform. Available gains include× 0.25 × 0.5 × 1, × 2 and
auto. Automode automatically adjusts the gain by the monitor. The right side of each
ECG waveform channel has given 1mv scale. The height of the 1mv scale is proportional to the
amplitude.
(a) Click ECG waveform and [ECG WAVE] menu will be displayed;
(b) Set[GAIN]to [× 0.25], [× 0.5], [× 1], [× 2] or[AUTO]

15-7
Attention
 When the input signal is too large, the peak may be truncated. The user can refer to the
actual waveform to manually change the gain of the ECG waveform in order to avoid the
incomplete waveform display.

15.6.4 Setting the Filter Mode


There are four filter modes: diagnostic mode, monitor mode, surgical mode and ST mode. The
diagnostic mode shows unfiltered ECG wave; the monitor mode can filter out the artifacts which
may lead to false alarms. The surgical mode in the operating room can reduce the artifact and
interference from electrical surgical unit. Filter mode is displayed above the first ECG waveform.
ST filter mode is user-friendly to conduct more accurate ST segment measurements. Frequency
response range of this mode is 0.05Hz-40Hz.The good scalability of low frequency ensures
undistorted interpretation of patient’s ST segment, and can effectively filter high-frequency
interference signals over 40Hzincluding power frequency interference. In this mode the user can
more accurately acquire the measured ST segment value by adjusting the position of the ST
segment analysis points.
(a) Click ECG waveform and [ECG WAVE] menu will be displayed;
(b) Set[FILTER]to [DIA] (diagnostic), [MON] (monitor), [SUR] (surgical) or [ST];

Warning

 Only under diagnostic mode will the actual ECG signal will be provided. ECG waveforms
have varying degrees of distortion under monitor mode and surgical mode. At this
time, the system can only provide the basic status of the ECG signal, which may have a
great impact on the result of the ST segment analysis. Under surgical mode, the
arrhythmia analysis result is also affected to some degree. So we recommended
that when the interference is small, try to use the diagnostic mode to monitor the
patient.

15.6.5 Setting the Calculation Channel


Heart rate calculation channels:
[CH1] represents that heart rate is calculated according to the ECG waveform of the first ECG
channel.
[CH1] represents that heart rate is calculated according to the ECG waveform of the second ECG
channel.
[AUTO] represents the monitor auto selects the channel to calculate the heart rate.
(a) Select ECG parameter area and the [ECG SETUP] menu will be displayed;
(b) Set [HR CHANNEL]to [CH1], [CH2] or [AUTO ];

15.6.6 Setting the Notch


Notch inhibits the 50Hz or 60Hz frequency components of signals collected. When the filter
mode is not the diagnostic mode, the system automatically enables the notch; while when filter
15-8
mode is the diagnostic mode, the user should select to enable or disable the notch function
according to the need.
(a) Select ECG parameter area and the [ECG SETUP] menu will be displayed;
(b) set the [NOTCH]to [50Hz], [60Hz] or [OFF]

15.6.7 Setting the Heart Rate Source


(a) Select ECG parameter area and the [ECG SETUP] menu will be displayed
(b) Set [HR FROM] to [ECG], [SpO2] or [AUTO];
 [ECG] means the heart rate is calculated based on the ECG waveform and HR value will be
the alarm source;
 [SPO2] means the heart rate is calculated based on the PLETH waveform and SpO2 value will
be the alarm source;
 [AUTO] means the monitor would decide the HR source based on the signal quality.

15.6.8 Activating or deactivating the Auto Lead Switch Function


If the auto lead switch function is activated, the monitor will auto recognize the lead type of the
ECG cable and auto switch the setting in [LEAD TYPE] to the corresponding lead type when
connecting the ECG cable of different lead types to the monitor.
1. Select ECG parameter area and [ECG SETUP] menu will be displayed;
2. Click [LEAD AUTO SELECT] to activating or deactivating the auto lead switch function.

15.7 ST Segment Analysis

15.7.1 About ST Segment Analysis


The normal heart beat and atrioventricular pacing are used for ST segment analysis. The monitor
analyzes these heart beats and calculates the elevation and depression of the ST segment. The
monitor can display the information in ST numerical form. It can continuously monitor all
available leads. For ST-segment analysis, the ECG waveform is not required to be displayed on
the monitor. For ST analysis, it usually uses a special filter which ensures diagnostic quality. If
you use the diagnostic filter mode to monitoring ECG, the ST segment of the ECG wave will be
slightly different from the ST segment in the ST fragment with the same waveform. In order to
diagnostically assess the ST-segment, please always switch to ST filter mode. You can also select
the monitor or surgical filter mode, but ST-segment data will have a serious distortion.
ST segment analysis can measure the elevation or depression of the specified ST-segment of a
lead.
Meaning of ST-segment measurement: A positive number indicates the elevation, a negative
number indicates depression
Measuring range of the ST segment: -2.0 ~ +2.0 mV.

15.7.2 Impact on ST-segment


Some clinical conditions make it difficult to get reliable ST monitoring, such as:
 Unable to obtain the leads with low noise;
15-9
 The irregular baseline resulting from arrhythmia such as atrial fibrillation / atrial flutter;
 The patient is continuous ventricular pacing
 Patients have left bundle branch block
When these things happen, you should consider to turning off ST monitoring

Warning
 The clinical significance of ST level change information provided by this monitor should
be decided by the physician.

15.7.3 On/Off ST Segment Analysis


(a) Select ECG parameter area, in the pop-up [ECGSETUP] menu, enter the menu [ST ANALYSIS];
(b) Set [ST ANALYSIS]to[ON] or [OFF].When it is set to[ON], ST value would be displayed in the
ECG parameter area;

15.7.4 Setting the ST Segment Analysis Point


Set the ST measurement point as R peak point. The ST measured values of every cardiac
integrated wave is the vertical distance between the peak point and the two measurement
points, as shown below:

R Wave

P T

Q
} DIF = ST Value
S
ST Measuring Point
BP: ISO
Initial Value +109 ms
-78 ms +109 ms

Figure 0-7ST analysis point

Attention
 If the patient's heart rate or ECG waveform changes obviously, you need to adjust the
location of ISO and ST point. The abnormal QRS wave groups are not considered when
the ST analysis is made.
 Method to adjust the ISO and ST point:
(a) Select ECG parameter area, in the pop-up [ECGSETUP] menu, enter the menu[ST
ANALYSIS];
(b) Set [ST ANALYSIS] to[ON];
(c) Select the [DEF POINT] to enter the [DEF POINT] window; the three vertical lines in
the window stand for the position of ISO, J, and ST respectively.
15-10
 The ISO cursor is to decide the equipotential point position against R peak point.
Locate the ISO point in the middle of the flattest part (between P wave and Q wave or
before P wave) in the baseline.
 The J cursor is to decide the J point position against R peak point, which is conducive
to correctly locate ST point. Locate the J point at the end of QRS wave group and the
start point of ST.
 ST point is located in a certain position with a fixed distance from J point—J+40, J+60
or J+80.Move the J cursor to locate the ST point in the middle of the ST.
(d) Select [ST LEAD] to choose an ECG lead whose J point and P wave are obvious. Click once,
name of ST would change from ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V1, ST-V2,
ST-V3, ST-V4, ST-V5, ST-V6 circularly.
(e) Select [ISO (ms)] and [ST (ms)] point respectively. Press and to make adjustment.
Select [J] to decide position of each point.

Warning
 Please ensure that the location of the ST measurement points suitable for the patients.

15.8 Arrhythmia Analysis


Arrhythmia analysis is used for the clinical monitoring of patients’ ECG to detect changes in
heart rate and ventricular premature beat, to save the arrhythmic events and to generate alarm
information. Arrhythmia analysis can be used to monitor pacemaker and non-pacemaker
patients. Doctors may, based on the arrhythmia analysis, evaluate the patient's condition (such
as heart rate, the PVCs (premature ventricular contraction) frequency, rhythm, and abnormal
heartbeat) and give the appropriate diagnosis and treatment. In addition to the detection of ECG
changes, the arrhythmia analysis can also be used to monitor patients and give appropriate

15-11
alarms.
The arrhythmia monitoring is disabled by default. Users can turn on this function according to
your need.
The function of arrhythmia monitoring can, by testing and classification of arrhythmias and heart
abnormalities, remind doctors to pay attention to the rhythm of the patient, and then give alarm.
The monitor can make 14 kinds of arrhythmia analysis.
Arrhythmia analysis system will store 200 alarm events and the operator can edit the arrhythmic
events in the menu.

15.8.1 On/Off Arrhythmia Analysis


(a) Select ECG parameter area, in the pop-up [ECG SETUP]menu, enter the [ARR ANALYSIS]
(arrhythmia analysis) menu;
(b) Select [ARR ANALYSIS] and select[ON]or [OFF];

15.8.2 Arrhythmia Alarm Settings


(a) Select ECG] parameter area, in the pop-up [ECG SETUP] menu, enter [ARR ANALYSIS]menu;
(b) Select [ARR ALARM];
(c) Select [ARR TYPE], select [ALL] or separate arrhythmia [ASYSTOLE], [VFIB/VTAC], [R ON T], [VT>
2], [COUPLET], [PVC], [BIGEMINY], [TRIGEMINY], [TACHY.], [BRADY], [PNC], [PNP], [MISSED
BEATS],[ARRHYTHMIA];
(d) Others:
Upper and lower limit of alarm:
One-time
Name Maximum Minimum
adjustment
PVCs 31 1 1

15.8.3 Arrhythmia Relearning


During ECG monitoring, when great changes of patient’s ECG template takes place, the users
should start the arrhythmia relearning process, which can help the monitor learn new ECG
template to correct arrhythmia alarm and HR values and restore ST measurement.
Particular procedures are:
(a) Select ECG parameter area, in the pop-up [ECG SETUP] menu, enter [ARR ANALYSIS]menu;
(b) Select [ARR RELEARN].

15.8.4 Arrhythmia Review


(a) Select ECG parameter area, in the pop-up[ECG SETUP] menu, enter [ARR ANALYSIS] menu;
(b) Select[ARR RECALL]to enter the arrhythmia review window, as shown below:

15-12
Figure 15-8 Arrhythmia review

(c) Adjust the [END TIME];


(d) Click an alarm event (like ** BIGEMINY) to enter the review window, as shown below; and
view the parameter values and waveform related to such alarm.

Figure 15-9Arrhythmia review

15-13
Chapter 16
Respiration Monitoring
16.1 Respiration
The monitor measures respiration according to the thoracic impedance values between two
electrodes and display a channel of RESP waveform on the screen.

16.2 Respiration Display

RESP waveform RESP alarm limit RR

Figure 16-1 RESP display

16.3 Placing Electrodes for RESP Measurement


RESP measurement applies the same electrodes and placement methods as that of ECG
monitoring. For example, if the 5-lead ECG cable is applied, the placement method is shown on
the figure below (for the placement methods of the ECG cable of other lead types, please refer
to ECG Monitoring):

Figure 16-2 Positions of electrodes of 5-lead ECG cable

16-1
Attention
 Put the green and the red electrodes at opposite angle so as to get the best
respiration wave. You should avoid putting the electrodes over the liver area and the
ventricle of the heart in the line between the respiratory electrodes, which can help to
avoid cardiac overlay or artifacts from the pulsing blood flow. This is particularly
important for neonates.

Lateral thoracic expansion

Some patients’ thorax may expand laterally, especially for the neonates. At the right time, two
RESP electrodes shall be placed on the right mid-axillary line and the left lateral thorax where
the patient has the maximum breathing movement to make sure that the breathing waveform is
distinct. See the following figure:

Abdominal respiration

For some patients the chest movement is limited so they primarily conduct an abdominal
respiration And right now, you shall remove the electrode which was placed on the left leg to the
left abdomen where there is maximum expansion to make sure the breathing waveform is clear.
See the following figure:

Attention
 RESP monitoring cannot be applied to the patient who moves frequently, because it may
lead to wrong alarms.

16-2
16.4 RESP Settings

16.4.1 Setting the Gain


Gain is used to adjust the size of RESP waveform. The alternative gains are×0.25, ×0.5, ×1,×2, ×3,
×4 and ×5.
(a) Select RESP waveform and the [RESP WAVE]menu will be displayed;
(b) Select [GAIN];
(c) Select [×0.25], [×0.5], [×1], [×2], [×3], [×4] or [×5].

16.4.2 Setting the Apnea Alarm Time


(a) Select RESP parameter area and the [RESP SETUP]menu will be displayed;
(b) Select [APNEA ALM] and then select [10S], [15S], [20S], [25S], [30S], [35S], [40S], [45S],
[50S], [55S], [1MIN] or [NO] for adult; select [10S], [15S], [20S] or [NO] for pediatric or
neonate.
 [10S] means that if apnea lasts for more than 10s and RESP alarm function is enabled,
the monitor will give an apnea alarm.
 [NO] means the apnea alarm function is disabled.

16.4.3 Setting the RESP Lead


RESP lead is where the current respiratory waveform comes from. There are lead Ian led II to
choose.
(a) Select RESP parameter area and the [RESP SETUP]menu will be displayed;
(b) Select [RESP LEAD] and select [I] or [II].

16.4.4 Setting the RESP Filter


Enhancing filter is to enhance filtering the interference of heart beat.
(a) Select RESP parameter area and he [RESP SETUP]menu will be displayed;
(b) Select [ENHANCE FILTER] to enable or disable the RESP filter function.

16-3
Chapter 17
SpO2 Monitoring
17.1 Definition of SpO2 Monitoring
SpO2 parameters measure blood-oxygen saturation, that is, the percentage of the total
oxyhemoglobin. When 97% of the total number of hemoglobin molecules combines with
oxygen in the arterial blood’s red blood cells, this blood will have 97% SpO2, and at the same
time the monitor reads 97% SpO2 value. This value shows the percentage of oxygen-carrying
hemoglobin molecules, constituting oxyhemoglobin. Furthermore parameters of the SpO 2 can
also provide pulse rate signal and plethysmography wave (PLETH).

17.1.1 Principle of Measuring SpO2


Pulse oximetry is a measurement of oxygen saturation. It is a continuous, non-invasive way of
determining the hemoglobin oxygenation saturation. It is involved in measuring how much light
emitting from the sensor side passes through the patient’s tissue (such as a finger or ear) and
then reaches the other side of the receiver.
Though the amount of light passing through depends on many factors, most of them are constant.
However, one of the factors is that blood flow in the arteries changes with time, since it is
pulsatile. It is possible to obtain arterial blood oxygen saturation by measuring the amount of
light absorbed during the pulse. And surveying pulse itself can supply a “PLETH” waveform and
pulse rate signal.
The main screen can display “SpO2” value and “PLETH” waveform.

Warning
 If there is carbonyl hemoglobin, methemoglobin, or dye dilution chemical present,
the SpO2 value will deviate.

17.1.2 Recognition of the type of SpO2 Sensor


The types of SpO2sensor have been configured when the equipment is delivered from the
factory, which is recognizable by the socket connected to the SpO2 sensor:
 Digital SPO2: SpO2 logo marked on the left side of the monitor.
 Nellcor SPO2: SpO2 logo and NELLCOR logo marked on the left side of the monitor.
 Masimo SPO2: SpO2 logo and MasimoSET logo marked on the left side of the monitor.
The wavelength range and maximum light output power of different transducers are very
important information to clinical doctors, such as, when proceeding photodynamic therapy
 Measurable wavelength of Digital SpO2 module sensor: red light 660nm, infraredlight
905nm.
 Measurable wavelength of Masimo SpO2 module sensor: red light 660nm, infraredlight
940nm.

17-1
 Measurable wavelength of Nellor SpO2 module sensor: red light 660nm, infraredlight
890nm.
The sensor’s maximum output light power is less than 18mW.

Warning
 This monitor can automatically identify the SpO2sensor. However, as the internal
hardware has been fixed before delivery from factory, the use of improper SpO2
sensor will lead to wrong measured values.

17.2 SpO2 Display

PLETH waveform Alarm limit SpO2 measured


value
Figure 17-1 SpO2 display

17.3 Safety Information


Warning
 Check whether the sensor cable is in good condition prior to monitoring. When you
discennect the SpO2 sensor cable from the monitor, the monitor will trigger a
technical alarm and display alarm message “SpO2 NO SENSOR” on the screen.
 If the sensor or its packaging has signs of damage, do not use it and return to the
factory.
 Continuous and prolonged monitoring may increase the risk of undesirable changes in
skin characteristics, such as irratation, reddenning, blistering, or even pressure
necrosis etc, especially for the neonates or patients with perfusion disorders and
varying or immature forms of skin. Check thesesor application site every two hours
and move the sensor if the skin quality changes.More frequent checkis required due to
different status of individual patents.
 High oxygen levels will have premature children been in danger of infecting the
crystal-like fibrous tissue disease. Therefore, the SpO2 alarm limit must be set
carefully based on generally accepted clinical practice.
 Do not entangle the cable of the sensor and electrical surgical unit.
 Do not placethe sensor on limbs with an arterial catheter or intravenous tube.
 The SpO2 simulator cannotbe used to verify the SpO2accuracy.

Attention

17-2
 Make sure that the nail covers the light inside the sensor. The sensor cable should be
placed on the back of hands.
 SpO2 waveform and pulse volume are out of proportion.
 Do not place the sensor and the cuff on the same limb while measuring, because the
NIBP measurement may occlude the blood flow and affect the readings of SpO2.

17.4 Steps of Monitoring


Warning
 Select the appropriate placement according to the instrument and its supporting
probe, which is fundamentally vital to neonates.
1. Turn on the monitor;
2. Insert the connector of the sensor cable into the SpO2socket.
3. Attach the sensor to the appropriate position on the patient.
Placement of finger adult/pediatric SpO2 sensor:

Figure17-2 Placement of finger adult/pediatric SpO2 sensor

Placement of neonate SpO2 sensor:


NeonateSpO2sensor consists of the Y-shaped SpO2sensor and sensor jacket. Insert the LED side
of the Y-shaped sensor in the upper groove of the sensor jacket, and respectively the PD side of
the sensor in the lower (See Figure 17-3), then the neonateSpO2sensor is shown in Figure 17-4.

Y-type SpO2sensor
SpO2sensor jacket

Figure17-3 NeonatalSpO2sensor (1)

17-3
Figure17-4 NeonatalSpO2sensor (2)

Attach the sensor to the neonatal hand or foot as shown below.

Figure17-5 Placementof the neonatal SpO2sensor

Attention
 When the accurate positioning between the test site and the probe fails, it may result
in wrong readings of SpO2, and even stop monitoring because of the failure of
searching pulse. In this case you should re-position these two.
 Excessive movement of measured sites may affect the accuracy of the measurement,
therefore, you should calm the patient or replace sites in order to reduce the impact
of excessive movement.

Warning
 In a long and continuous monitoring process, it is advisable to check periodically the
positioning of the sensor to avoid inaccurate measurement due to changing in the
positioning because of moving or other factors.

17.5 Limits in Measurement


During operation, the following factors can affect the accuracy of SpO2 measurement :
 High-frequency radio interference, for instance, interference self-generated from the host
system or from ESU connected to the system.
 During magnetic resonance imaging scanning (MRI), do not use the photoelectric oximeter
and oxygen sensor, since induced currents may cause burning.
 Intravenous dye.
 Patient’s excessive movement.
17-4
 External ray radiation.
 Improper installation of sensor or improper contact position with the object .
 Sensor’s temperature (optimal temperature should be among 28 ℃ - 42 ℃) .
 The sensor is placed on the limbs with a blood pressure cuff, arterial catheter, or the
pipeline of body cavity.
 The concentrations of non-functional hemoglobin such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb) etc.
 Extremely low degree of SpO2.
 The measured area has poor circulation.
 Syndromes such as shock, anemia or low temperature etc and application of
vasoconstrictiondrugs can reduce blood flow to the level of not being able to be measured.
 Measurement also depends on both the oxyhemoglobin and deoxyhemoglobin’s absorption
of specific wavelengths of light. If any other substancesabsorb the same wavelength,
they will generate false measurement or lower SpO2 values. These substancesare as follows:
COHb, MetHb, methylene blue , indigo rouge.
 It is recommended to use only the SpO2 probe described in the accessories.

17.6 SpO2 Settings

17.6.1 Setting the Intelligent Alarm


1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [SAT SECOND]
3. Select [10], [25], [50], [100]seconds or [Disable];
NOTE: This feature is only available on NELLCOR SpO2.
Intelligent alarm is designed to reduce false alarms, help the doctor grasp more accurate and
timely changes in SpO2. For example, set the intelligent alarm range as 50, the upper limit of
NELLCOR SpO2 alarm as 97%, and lower limit as 90%, the measured SpO2 value turns out to be
80% and remains for 3 seconds, then, it decreases to 78% and remains for 2 seconds, so
calculating from the time the alarm limit is exceeded, the sound-light alarm will initialize
instantly only when the SpO2 value is out of the alarm range for 5 seconds. Meanwhile , the
circle beside the SpO2 value returns to origin. Its calculation is as follow:
Minus percentage points x seconds = SatSeconds integer
values of the calculated SatSeconds are shown:
%SpO2 second SatSeconds
(90%-80%) x 3= 30
(90%-78%) x 2= 24
Total SatSeconds = 54

17-5
Figure17-6 Example figure

SatSeconds Example:
After about 4.9 seconds, the instrument will report SatSeconds alarm, because 54 is beyond the
intelligent alarm range 50 SatSeconds.
Within a few seconds , saturation will fluctuate a bit, and not be stable. Generally, the patient's
SpO2 value may fluctuate between the upper and lower limits of the alarm, and may re-enter to
non-alarm range several times. In this volatile period, the system will store the positive and
negative points of the SpO2, till it reaches the SatSeconds limit or patient’s SpO2 values
returned to and remains in the non-alarmrange.

17.6.2 Setting the Average Time


The average time, SpO2 value displayed on the monitor, is the result of averaged data collected
during a period of time. The shorter (or longer) the average time is, the faster (or more slowly)
the monitor will respond to the patient’s SpO2 value changes, but with lower (or higher)
measurement accuracy. Please set a shorter average time for critically ill patients so as to
analyze the disease in time.
1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [AVG TIME];
3. Select [2-4s], [4-6s], [8s], [10s], [12s], [14s] or [16s].
NOTE: This feature is only available on Masimo SpO2.

17.6.3 Setting the Calculation Sensitivity


There are three kinds of calculation sensitivities, including normal, sensitive and APOD. For
typical patient monitoring, use “normal” sensitivity. As for those patients who have moist skin,
active exercise, or for other reasons, the sensor may be dropped off a patient’s body, then use
the “sensitive” sensitivity. If the patient has very low perfusion levels and wants to improve the
sensitivity performance, please use the “APOD” sensitivity.
1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [SENSITIVE];
3. Select [Normal], [High] or [APOD].
NOTE: This feature is only available on Masimo SpO2.

17-6
17.6.4 Setting the Signal IQ
When it is turned on, below the PLETH waveform, there is a logo for signal collection, which is
mainly reflecting the quality of the signal during the acquisition process. This signal disappears
as it is turned off.
1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [SIGNAL ON/OFF];
3. Select [ON] or [OFF].
NOTE: This feature is only available on Masimo SpO2.

17.6.5 Setting the Quick SpO2


1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [FAST SAT];
3. Select [ON] when you start the rapid SpO2 measurement;
4. Select [OFF] to not use this feature.
NOTE: This feature is only available on Masimo SpO2.

17.6.6 Setting the Pulse Sound


1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [BEEP];
3. Select [ON] and you can get a prompt of pulse sound;
4. Select [OFF] and there is no prompt of pulse sound.
NOTE: This feature is only available on Masimo SpO2.

17.7 Masimo Information

 Masimo Patent
It contains one or more of the following U.S. patents: RE38,492, RE38,476, 6,850, 787,
6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530,
6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872,
6,229,856, 6,206,830, 6,157,830, 6,067, 462, 6,011,986, 6,002,952, 5,919,134, 5,823,950,
5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international patents or
a item or a number of patents referred to in the www.masimo.com/patents. Including
functions from products of Satshare ® and the U.S. Patent 6,770,028. Other patents are
under application.
 Other Information
© 2006 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare,
SET, LNOP, LNCS, and LNOPv are federal registered trademarks of Masimo Corporation's.
RadNet, Radicalscreen, signal IQ, FastSat, fastStart are trademarks of APOD and Masimo
Corporation.
17-7
17-8
Chapter 18
NIBP Monitoring
18.1 Overview
The non-invasive blood pressure (NIBP) measurement uses oscillation method and is available
for adults, pediatric and neonates.
When perfoming NIBP measurement on a pediatric and neonate, you must ensure that the
correct measure mode is selected. Wrong measure mode could jeopardize patient safety,
because high blood pressure of adults is not suitable forpediatric and neonates.
According to the IEC601-2-30/EN60601-2-30 standard, NIBP measurement can be conducted
during electrosurgical operation and during the discharging period of defibrillator

18.2 NIBP Display


NIBP measured values are displayed in the parameter area.The following figure is for reference
only.The NIBP display on your monitor might be somewhat different:

1 2 3 4 5

6
8

10 9

Figure18-1 NIBP display

1 Time of last measurement 2 Patient type

3 Diastolic pressure 4 Measurement Mode

5 Pressure unit: mmHg or kPa 6 Mean arterial pressure

7 Systolic pressure 8 Alarm limit of systolic pressure

9 Cuff pressure 10 Status message

18-1
18.3 Precautions for NIBP measurement
Warning
 Before starting the measurements, make sure the selected measure mode applies to
your patients. Using other than the neonatal mode on a neonatal patient may put the
patient in danger.
 Do not install the cuff on a limb with an intravenous infusion tube or a catheter. During
cuff inflation, if infusion is lowed down or clogged, the area around the tube may be
damaged.
 Ensure theconnection tubing that attached blood pressure cuff and monitor is with no
kinking.
 Too frequent measurements can cause injury to the patient due to blood flow
interference.
 Do not place the cuff over a wound, as this can cause further injury.
 Do not place the cuff on any limb where intravascular access or therapy, or an
arterio-venous (A-V) shunt is present, as this could cause temporary interference to
blood flow and result in injury to the patient.
 Do not place the cuff on the arm on the side of a mastectomy.
 Pressurization of the cuff can temporarily cause loss of function of simultaneously used
monitoring equipment on the same limb.
 NIBP measurement cannot be performed onthose patients suffering from sickle-cell
disease or skin damage or any anticipated damage.
 For a patient suffering from serious disturbance of blood coagulation, the decision to
operate automatic blood pressure measurement must be made according to the clinical
evaluation, because the friction area between body and sleeves has the risk of
hematoma.

18.4 NIBP Measurement

18.4.1 Measurement Steps


1. Conenct the NIBP cuff to the monitor and turn on the monitor.
2. Attach a suitable cuff to the patient's upper arm or thigh in the following ways
( see figure 18-2).

 Verify that the cuff is completely deflated.


 Use a cuff with suitable size on the patient. Be sure that the cuff is not too tightly wrapped
around the limb, otherwise it may cause discoloration or even ischemia to the far end of
the limb.

18-2
Figure 18-2Cuff usage

Attention
 The width of the cuff should be 40% (or 50% for neonates) of the circumference of the
limb, or 2/3 of the length of the upper arm. The length of the inflated part of the cuff
should be long enough to wrap 50~80% of the limb; a cuff of wrong size will produce
a wrong reading. If you have a problem about the size of the cuff, use a larger cuff in
order to reduce errors.
Adult/pediatric/neonate resuable cuff:

Patient type Limb Circumference Cuff width Gas tube length

Neonate 10~19 cm 8 cm

Pediatric 18~26 cm 10.6 cm

Adult 1 25~35 cm 14 cm 2m

Adult2 33~47 cm 17 cm

Leg 46~66 cm 21 cm

Pediatric/neonate/adult disposable cuff:

Size Limb Circumference Cuff width Gas tube length

1 3.1~5.7 cm 2.5 cm

2 4.3~8.0 cm 3.2 cm
2m
3 5.8~10.9 cm 4.3 cm

4 7.1~13.1 cm 5.1 cm

 Check if the edges of the cuff are located inside the range marked by < - >. If not, replace
the cuff with a more suitable one.
3. Check that the monitor mode is correct (displayed in the NIBP parameter area). To change
18-3
the measure mode, please enter the menu [NIBP SETUP] to change [MEASURE MODE].
4. Press the key on the front panel or click [NIBP START] on-screen key to inflate the NIBP
cuff.

Body parts used for pressure-measuring should be in the same horizontal location with patient's
heart. If unable to do so, it is necessary to use the following correction method to modify the
measurement results:
 If cuff is above the heart level location, 0.75mmHg (0.10kPa) should be added to the
displayed value for per centimeter gap.
 If cuff is below the heart level location, the displayed value should minus 0.75mmHg
(0.10kPa) for per centimeter gap.
In order to obtain accurate blood pressure measurement for the hypertension patient, the
patient position should be as follows:

a) Comfortably seated

b) Legs uncrossed

c) Feet flat on the floor

d) Back and arm supported

e) Middle of the cuff at the level of the right atrium of the heart

18.4.2 Operation Prompt


(1) Start an auto measurement:
Enter the menu [NIBP SETUP] and select [INTERVAL] to select the time interval for auto
measurement, and then press the key on the front panel or click [NIBP START]
on-screen key to inflate the NIBP cuff and measure the NIBP as per the set time interval.
(2) Start a manual measurement:
 Enter the menu [NIBP SETUP] and set [INTERVAL] to [MANUAL], and then press the
key on the front panel or click [NIBP START] on-screen key to start a manual
measurement.
 You can press the key to start a manual measurement after the auto measurement
stops. If you press the key again, the manual measurement will be stopped and
auto measurement resumes.
(3) Start a continuous measurement:
Enter the menu [NIBP SETUP] and select [CONTINUAL] to start a continuous measurement
lasting for 5 minutes.
(4) Stop the measurement:
In the measurement process, you can press the key to stop at any time.

18-4
Warning
 If the NIBP measurement under the auto or continuous measure mode lasts too long, the
limb with the cuff may suffer from purpura, ischemia or nerve damage. During patient
monitoring, you should check the color, warmness and sensitivity of the far end of the
limb from time to time. Once you observe any anomaly, place the cuff on another place
or stop measurement immediately.

Attention
 The patient should relax as much as possible and not talk during the measurement
procedure.
 5 min should elapse before the first reading is taken.
 If unexpected readings are obtained, first the operator should use the same method to
take measurement and then check the monitor function.

18.4.3 Measurement Limitations


According to the patient's condition, oscillatory measurement has some restrictions. Such
measurements are looking for regular impulse waves produced by arterial pressure. In case the
patients’ condition makes this kind of detection difficult, measurement values will become
unreliable and load time will increase. Users should be aware that the following conditions will
interfere with the measurement method, so that pressure is not reliable or load time increases.
In this case, the patient's condition will make measurement impossible.
(1) Patient Mobility
If patient is moving, shaking or in spasms, measurement will be unreliable or even
impossible, as these may interfere with the detection of the arterial pressure pulse and load
time will be extended.
(2) Arrhythmia

If patient has shown arrhythmia caused by irregular heart beats, measurements are
unreliable or even impossible and load time will be extended.
(3) Heart-Lung Machine

If patient is connected to an artificial heart-lung machine, measure cannot be conducted.


(4) Pressure Change

If within a certain time, arterial pulse pressure is being analyzed to get the
measurements, when blood pressure in patients is rapidly changing, measurement will be
unreliable or even impossible.
(5) Severe Shock

If a patient is in serious shock or hypothermia, the pressure will be unreliable. The reducing
blood flowing to periphery would cause a decline in arterial pulse.
18-5
(6) Limit Heart Rate

Blood pressure measurement cannot be performed when heart rate is lower than 40bpm
(beats per minute) or higher than 240bpm (beats per minute).
(7) Obese Patients

A thick layer of fat around a limb damps oscillations from the artery, thus preventing them
from reaching the cuff. The accuracy is lower than the normal one.

18.5 NIBP Settings

18.5.1 Setting the Measure Mode


Measure mode includes adult, child and neonate, which is the same as the patient type.
(a) Select NIBP parameter area and the [NIBP SETUP]menu will be displayed;
(b) Select [MEASURE MODE]
(c) Select[ADU], [PED] or[NEO] ;

18.5.2 Setting the Interval Time


(a) Select NIBP parameter area and the [NIBP SETUP]menu will be displayed;
(b) Select [INTERVAL];
(c) Select [MANUAL]to conduct a manual measurement;
(d) Select [1MIN], [2MIN], [3MIN], [4MIN], [5MIN], [10MIN], [15MIN], [30MIN], [60MIN], [90MIN],
[120MIN], [180MIN], [240MIN] or [480MIN] for auto measurement;

18.5.3 Setting the Pressure Unit


(a) Select NIBP parameter area and the [NIBP SETUP] menuwill be displayed;
(b) Select [UNIT];
(c) Select [mmHg] or [kPa];

18.5.4 Setting the Pre-inflation Value


(a) Select NIBP parameter area and the [NIBP SETUP] menuwill be displayed;
(b) Select [INFLATION] and select the suitable pre-inflation value;
 Neonates: the range of the pre-inflation value is 60-120 mmHg, the default value is
100mmHg
 Pediatric: the range of the pre-inflation value is 80-200 mmHg, the default value is
120mmHg
 Adults: the range of the pre-inflation value is 80-240 mmHg, the default value is 160mmHg;

18.6 NIBP Reset


Select NIBP parameter area and select [RESET]. Reset can restore the inflation value of the blood
pressure pump to the initial setting. If the blood pressure pump is working abnormally, it can be
checked by means of reset and will recover from any anomaly caused by an accidental reason.

18-6
Chapter 19
Temperature Monitoring
19.1 Overview
This monitor has two temperature measurement channels; body temperature can be measured
by temperature probes.

19.2 TEMP Display


The parameter area can display the values and units of two channels of body temperatures ([T1]
and [T2]), as well as the temperature difference ([TD]). By selecting TEMP parameter area, you
can open the[TEMP SETUP]menu.

Figure 19-1 TEMP display

19.3 Safety Information


Warning
 Check whether the TEMP probe cable is in good condition prior to monitoring. When you
discennect the TEMP probe cable from the monitor, the monitor will trigger a technical
alarm and display alarm message “T1 SENSOR OFF” or “T2 SENSOR OFF” on the screen.
 Be careful in handling the TEMP probe and cable, when not in use, the probe and cable
should be pulled into the loose ring. If the wire is pulled too tight, it will lead to
mechanical damage.
 Calibrate the temperature measuring instrument at least once every two years ( or
according to the required time in the hospital directive rules ). Please contact
BPLMTPL when calibration is needed.

Attention
 Disposable temperature probe can only be used once.
 During the monitoring process, the temperature measuring instrument will
automatically check itself once per hour. Self-checking will last 2 seconds and will not
affect the temperature monitoring.

19.4 Steps of TEMP Measurement


19-1
(1) If you are using a disposable temperature probe, first connect the temperature probe to the
cable first and then connect the cable to the TEMP socket on the monitor. For reusable
temperature probe, it can be directly connected to the TEMP socket.
(2) Securely attach the temperature probe onto the patient’s body.
(3) Turnonthe monitor.

19.5 Setting the TEMP Unit


(a) Select TEMP parameter area and the [TEMP SETUP]menu will be displayed;
(b) Select [TEMP UNIT];
(c) Select [℃] (Degree Celsius) or [℉] (Degree Fahrenheit) according to your habit.

19-2
Chapter 20
CO2 Monitoring
20.1 Overview
This chapter just introduces the CO2 measurement mode by sidestream and mainstream CO2
modules, which is different from the operating mode of CO2 measured in anesthetic gas. Please
note their differences.

CO2 measurement modes are divided into sidestream and mainstream.

 For sidestream measurement mode, the respiratory gases inside patient airways are
sampled with a constant sampling flow and analyzed by remote CO2 sensor built in the
measurement system.

 For mainstream measurement mode, CO2 sensors are mounted on an airway joint that is
directly inserted into the respiratory system of a patient.

CO2 measurement provides:


• CO2 waveform.
• End-tidal CO2 (EtCO2):CO2 value measured at the end-tidal of respiration.
• Minimum inspiratory CO2 (FiCO2):The minimum value measured during respiration.
• Airway Respiration Rate (AWRR):respiration rate per minute derived from
CO2 waveform.

Figure 20-1 CO2display

20.2 Understanding CO2Plug-in Modules

CO2 module interface


CO2 module interface

20-1
Figure 20-2 CO2module (left: RESPIRONICS sidestream module; middle: PHASEIN ISATM;
right: PHASEIN IRMATM)

Warning
 The bumping and shaking of the CO2 module should be avoided whenever possible.

Attention
 Do not use this monitor in the presence of combustible anesthetic gas.
 This monitor can be operated only by professionals who are well trained and
familiar with this user manual.

20.3 Measuring Principle and Working Process


The CO2 measuring principle is mainly based on the characteristic that CO2 can absorb the
infrared rays with a wavelength of 4. 3um. The measuring method works as follows: CO2 is
introduced to a measuring chamber of which one side is irradiated by infrared rays, and sensors
are employed to measure the attenuation degrees of received infrared rays at the other side of
the measuring chamber, and the attenuation degree is directly proportional to the CO2
concentrations.
The conversion between CO2 partial pressure and CO2 concentration is:
CO2 Partial Pressure (mmHg)= CO2 Concentration (%)×Pamp (Ambient Pressure)
For example:5% CO2 = 38mmHg at 760mmHg
5% CO2 = 35mmHg at 700mmHg
CO2 Module:adopting Autorun instruction measurement mode, and the waveform is sampled
once every 31 milliseconds.

20.4 Operating Instruction for CO2 Connection


(1) The schematic of connection of the mainstream module produced by the RESPIRONICS
company is shown in the figure below:

Figure 20-3Mainstream CO2 module connection schematic

20-2
(2) The schematic of connection of the sidestream module produced by the RESPIRONICS
company is shown in the figure below:

Figure 20-4Sidestream CO2 module connection schematic

(3) The schematic of connection of the ISA™sidestream analyzer produced by the PHASEIN
company is shown in the figure below:

Sampling tube

Figure 20-5ISA™ sidestream analyzer (ISA CO2) CO2 connection schematic

(4) The schematic of connection of the IRMA™ mainstream analyzer produced by the PHASEIN
company is shown in the figure below:

Figure 20-6IRMA™ mainstream analyzer (IRMA CO 2) CO2 connection schematic

The monitor supports CO2 measurement by using sidestream or mainstream module produced
by the RESPIRONICS Company, or an ISA™ sidestream analyzer (ISA CO2 (CO2) CAT. NO. 800101)

20-3
produced by the PHASEIN Company.

Warning
 Before use, please check airway joints. Do not use when visible damage or breaks are
found on the airway adapter.
 When CO2 is not used, it must be turned off, otherwise the CO2 module will be in
a working condition all the time.

20.5 Measuring Procedure of RESPIRONICS Mainstream and

Sidestream Modules
The RESPIRONICS sidestream analyzer operating procedure is roughly the same as the
mainstream analyzer operating procedure; please refer to the sidestream analyzer operating
procedure for the mainstream analyzer operating procedure.
(1) Turn on the monitor.
(2) Connect the CO2 plug-in module to the monitor; the indicator of the CO2 module will
illuminate, which means that the module has been successfully connected to the monitor;
otherwise, please reconnectthe CO2 module.
(3) Make connections according to the CO2 module type or Figure 20-3 or Figure 20-4, and
connect the CO2 module interface cable to the CO2 module.
(4) In the [CO2 SETUP] menu, set [O2 COMPEN](Oxygen Compensation) to 21 (usually, although
it is 21 in this option, in order to make sure that itis in an activated state, the customer still
needs to reselect it);
(5) In the [CO2 SETUP] menu, select an appropriate [BALAN GAS](Balancing Gas): [ROOM AIRE],
[N2O] or [HELIUM] (usually if N2Oand helium are used indoors, you can just select room air);
(6) In the [CO2 SETUP] menu, select a correct [ALTITUDE(m)]:0~5029.2m. The default is 0 meter.
When the CO2 value is higher or lower than the normal value, users should choose
appropriate atmospheric pressure based on the local condition (the atmospheric pressure is
corresponding to the altitude, so it can only be adjusted via attitude). Refer to the following
table for its standard:
Air Pressure Conversion Table – EtCO2Reading Based on Altitude
Altitude Atmospheric Pressure 5%CO2
Inch m mmHg ETCO2 mmHg
Sea Level (0) Sea Level (0) 760 38
500 152. 4 745 37
750 228. 6 738 37
1, 000 304. 8 731 37
1, 500 457. 2 717 36
2, 000 609. 6 704 35
2, 500 762 690 35

20-4
3, 000 914. 9 677 34
3, 500 1066. 8 665 33
4, 000 1219. 2 652 33
4, 500 1371. 6 640 32
5, 000 1524 628 31
5, 500 1676. 4 616 31
6, 000 1828. 8 604 30
6, 500 1981. 2 593 30
7, 000 2133. 6 581 29
7, 500 2286 570 29
8, 000 2438. 4 560 28
8, 500 2590. 8 549 27
9, 000 2743. 2 539 27
10, 000 3048 518 26
10, 500 3200. 4 509 25
11, 000 3352. 8 499 25
11, 500 3505. 2 490 24
12, 000 3657. 6 480 24
12, 500 3810 471 24
13, 000 3962. 4 462 23
13, 500 4114. 8 454 23
14, 000 4267. 2 445 22
14, 500 4419. 6 437 22
15, 000 4572 428 21
15, 500 4724. 4 420 21
16, 000 4876. 8 412 21
16, 500 5029. 2 405 20
16, 800 5120. 6 400 20
Table 17-1
Note:It is assumed that the atmospheric pressure is 760mmHg and the ambient temperature is
0℃ at the sea level. Calculation of Atmospheric Pressure:the sea-level based ambient
temperature is assumed as 0℃. Refer to the above Table.

Warning
 By setting Altitude, the monitor is not automatically changed with air pressure
compensations. Correct Altitude must be set when measuring CO2 for the first time.
Improper setting of Altitude will result in incorrect CO2 readings. A 5% CO2 deviation is
generally generated corresponding to difference of each 1000m height.
(7) In the [CO2 SETUP] menu, select [ZERO CAL](Zeroing calibration) and the status message
[ZERO IN PRO 30S]will be displayed at the lower right corner of CO2 parameter area. You
can only start measuring CO2 only after zeroing.

20-5
20.6 Measuring Procedure of PHASEIN Sidestream and Mainstream

Analyzers
The PHASEIN sidestream analyzer operating procedure is roughly the same as the mainstream
analyzer operating procedure; please refer to the sidestream analyzer operating procedure for
the mainstream analyzer operating procedure.

20.6.1 Measurement Steps


If you want to set the host monitoring equipment in order to start gas analysis, please execute
the following procedure:
a) Start the monitor.
b) Connect the CO2 plug-in module to the monitor.
c) Connect the Nomoline sampling line to the ISA analyzer (CO2 plug-in module).
d) Connect the interface cable of the ISA analyzer to the CO2 module.
e) Set appropriate [O2 COMPENSATE](Oxygen Compensation), [N2O COMPENSATE](Laughing
Gas Compensation).
f) Connect the outlet of the sample gas to the discharge system, or to make the gas to flow
back to the patient’s circuit.
g) If the LED is green, ISA Analyzer is available.
h) Carry out pre-use check.
i) If there is nothing wrong, start to monitor the CO2 Gas.

20.6.2 Pre-use Check


Before connecting the Nomoline sampling line to the breathing circuit, carry out the following
steps:
a) Connect the sampling line to the gas entrance interface (LEGI) of the ISA CO2 module.
b) Check whether the green light of LEGI is steadily on or not (indicating the system is normal).
c) Breathe to the sampling line, check if valid CO2 waveforms and values are displayed on the
host monitoring equipment.
d) Use the fingertip to occlude the sampling line and wait for 10 seconds.
e) Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light.
f) If applicable: perform a tightness check of the patient circuit with the sampling line
attached.

Attention
 The end of the gas circuit adapter which connects the gas sampling tubeshould point
upward so as to prevent the condensing water drops entering the gas sampling tubeand
blocking it up.

20-6
Warning
 Hang the external CO2 analyzer onto the CO2 bracket on the rear casing of the
instrument; prevent the dropping damage of the CO2 module.
 Unless HME is used to protect the IRMA probe, the state indicating LED should face
upward all the time during IRMA probe placement.
 Do not pull the cable of ISA sidestream Gas Analyzer.
 Do not operate the ISA sidestream Gas Analyzer in the environment beyond the
designated working temperature.
 Make sure all connections are firm and reliable. Any leakage will result in the inclusion
of ambient air in the patients respiratory gas, which leads to a wrong reading.

20.7 CO2 Setting

20.7.1 Setting the Pressure Unit


(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select [UNIT];
(c) Select [mmHg] or [kPa];

20.7.2 Setting the Gas Compensation


(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select [O2 COMPEN](Oxygen Compensation)and select [HIGH], [MED] or [LOW];
(c) Select [N2O COMPENSATE]and select [ON] or [OFF].
NOTE: This feature is only available on PHASEIN CO2.
Gas compensation setting varies with different CO2 modules;
(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select [O2 COMPEN](Oxygen Compensation) and set the value;
NOTE: This feature is only available on RESPIRONICS CO2.

Warning
 Please set the compensation of various gases based on actual circumstances; otherwise
the measured result may seriously deviate from the actual value, which will result in
a wrong diagnosis.

20.7.3 Setting the Apnea Alarm Time


(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select [APNEA ALM](ApneaAlarm);
(c) Select [10S], [15S], [20S], [25S], [30S], [35S], [40S],[45S], [50S], [55S], [1MIN]or [NO] for
adults and select [10S], [15S], [20S]or [NO] for pediatric/neonates.
 [10S] means when the time for the patient to have apneaexceeds 10 seconds, and the
20-7
CO2 alarm function is enabled, the monitor will trigger an alarm; and so on.
 [NO]: means apnea alarm function is disabled.

20.7.4 Setting theAltitude


(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select[ALTITUDE (m)];
(c) Setting the altitude and[BARO PRE](barometric pressure) displays different atmospheric
pressures according to auto-set data.
NOTE: This feature is only available on RESPIRONICS CO2.

20.7.5 Setting theBalance Gas


(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed
(b) Select [BALAN GAS](balance gas) ;
(c) Select [ROOM AIR], [N2O] or [HELIUM];
NOTE: This feature is only available on RESPIRONICS CO2.

20.8 Discharging Waste Gases


When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from
polluting the operating room. Usually the gas outlet should be connected to (via the gas
discharging tube connected to the sample gas outlet of the host equipment) a discharging
system (used for discharging collected gases) or the patient circuit (used for the back flow of
collected gases).

Warning
 When perform measurement on the patients who are receiving or have recently received
anesthetics, connect the outlet on the module to a waste gas processing system,
anesthesia machine or ventilator, so as to prevent medical staff from inhaling the
anesthetic.

20.9 Zeroing of RESPIRONICS Mainstream and Sidestream Module


Please zero before monitoring CO2; zeroing is to eliminate the effect of baseline drifting on the
results during measurement, thus ensuring the correctness of measured results.
Usually, the module will zero itself automatically when necessary. The user can zero the module
manually when the user considers it necessary:Select [CO2] in the parameter area, in the [CO2
SETUP] menu popping up, select [ZERO CAL] to zero the CO2 module. During zeroing, make sure
that the patient circuit is exposed to the ambient air (21% oxygen and 0% CO2) for
approximately 30 seconds; when the 30s zeroing prompt on the screen ends, it means zeroing is
completed.

20-8
20.10 PHASEIN Mainstream and Sidestream Analyzer Related

Information

20.10.1 Zeroing
An infrared gas analyzer needs to establish a zero reference level for CO2, N2O and anesthetic
gas measurement. This zero calibration is called as “zeroing” here.

 Automatic Zeroing
The ISA sidestream gas analyzer performs zeroing automatically by switching the gas sampling
from the respiratory circuit to the ambient air. The automatic zeroing is performed every 24
hours and takes less than 3 seconds for ISA CO2 gas analyzers and less than 10 seconds for ISA
multi gas analyzers. If the ISA sidestream gas analyzer is equipped with an oxygen sensor,
automatic zeroing also includes the room air calibration of the oxygen sensor.
 Manual Zeroing
Select AA parameter area, in the pop-up [AA SETUP] menu, select [ZERO CALIBRATING]. During
zeroing, make sure that the patient circuit is exposed to the ambient air (21% oxygen and 0%
CO2) for approximately 30 seconds; when this option issettable, zeroing can be executed.

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

20.10.2 CO2 Module Indicator Status


Overview of States Indicated by LEGI:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check sampling tube

20.10.3 Others
The operating methods for CO2 analyzers and AG analyzers produced by the PHASEIN are
identical. Therefore, for such contents as “adverse effects on performance, safety information,
airway obstruction, consumables, safety symbol, patent and trademark” with respect to the CO2
analyzer described in this section, the user can refer to relevant contents in AG monitoring.

20-9
Chapter 21
AG Monitoring
21.1 Overview
AG module can measure the anaesthetic gas and respiratory gas of the patient during anesthesia
and also provide end-tidal(Et) value and fraction of inspired (Fi) value of the following gases:
 Carbon dioxide (CO2) – The measured value is EtCO2 (maximum exhaled value – maximum
exhaled value detected during respiration).
 O2 – Oxygen.
 Nitrous oxide (N2O).
 MAC – Minimum alveolar concentration, which is the basic index indicating the depth of
inhalation anesthesia.
 Airway respiration rate (AWRR) – The times of respiration per minute.
 End-tidal respiration (Et) and fraction of inspired (Fi) values of AA:
 Halothane: HAL
 Isoflurane: ISO
 Enflurane: ENF
 Sevoflurane: SEV
 Desflurane: DES

21.2 Understanding the AG Module

AG module interface
AG/O2 general module
interface

Figure 21-1AG and O2module

21.3 Measurement Principle of Anaesthetic Gas


The Respiratory Gas can be analyzed by various measurement principles. The Dispersive Infrared
(DIR) Method or the Nondispersive Infrared (NDIR) Method are commonly used to insulate the
absorption characteristics of the gas sample. The DIR Method is to use a single optical light filter
and a prism or a diffraction grating to separate the wave length of each kind of anesthetic. And

21-1
NDIR Method is to get the infrared light go through several narrow-band light filters and
determine what kind of gas exists in the mixed gas.
The most commonly used gas analytical method is the one based on the medium of NDIR Method.
The measurement principle is based on that many gases absorb the infrared energy of a
certain wave length.
Usually the sidestream sampling infrared multi-gas analyzer continuously sucks in gas samples
from the junction of the patient circuit and an airway device (e.g. a face mask, an airway tube or a
throat mask tube). A modern analyzer’s rate of gas sampling from the respiration circuit is
somewhere between 50ml/min and 250ml/min. Via a small cup or a sample compartment, the
sample gas passes through the infrared transmitter, the light filter and the infrared detector. The
output signal of the infrared detector is in proportion to the infrared energy which has not been
absorbed by the gas. In order to simultaneously quantify and identify multiple gases, such as
laughing gas, carbon dioxide and five inhalational anesthetic gases, multiple light filters are
needed. Detected signals are amplified, and converted by means of complex algorithm executed
by a microprocessor. You need to note that oxygen cannot be detected by mean of infrared
spectrometry. The gas analyzer measures oxygen by applying auxiliary technology such as
paramagnet or oxygen sensor.

21.4 AG Display

Figure 21-2AG display

The monitor can display measured waveforms and parameter values on the screen by AG
module, which include:

 CO2, O2, N2O and AA waveforms;

 AWRR: Airway respiration rate;

 MAC: Minimum alveolar concentration;

 End-tidal (Et) and fraction of inspired (Fi) values of CO2, O2, N2O and AA.

AA stands for one of the Anaesthetic Gases of Des (Desflurane), Iso (Isoflurane), Enf (Enflurane),

21-2
Sev (Sevoflurane) and Hal (Hhalothane).
When the AG analyzer detects two or more anesthetic gases, the primary anesthetic gas is
displayed in the waveform area of the screen, but the secondary anesthetic (s) is/are not
displayed, only [FOUND TWO AG] (Two anesthetic gases are detected) is displayed in the prompt
message area.

Attention
 Only the waveform and value of one anesthetic agent can be displayed at a time. When
the second anesthetic gas appears, prompt message [FOUND TWO AG]will be displayed
in the prompt message area.

21.5 MAC (Minimum Alveolar Concentration) Calculation


MAC (minimum alveolar concentration ) is a standard for comparing the potency of
inhalationanaesthetics. The MAC value stands for the alveolar concentration of an anesthetic (at
one atmosphere) that, in 50% of a tested population,prevents gross muscular movement in
response to a painful, standardized stimulus.
If a mechanism to determine MAC values is carried out in the host equipment, the
algorithmsysed for this calculation must be adequately documented.
he NAC value may be calculated and displayed by using end-tidal (Et) gas concentrations
according to the following formula:

For example, when using one or several anesthetics, the anesthesia module measures and get
that the patientt the end of the exhalation.ponse for 50% people tested on standardizeN2O. So
the MAC value is equal to

Attention
 Altitude,patient age and other individual factors are not considered in the formula
above.

21.6 Oxygen Sensors


Paramagnetic oxygen analyses are based on the measurements of the atrractive force exerted by
a strong magnetic filed applied to the oxygen molecules in a gas mixture. The paramagnetic
analyzer distinguishes oxygen from other gases as a function of their magnetic
susceptibility. Due to its paramagnetic nature, oxygen is attracted into the magnetic field, while
most other gases are not. On a scale, where oxygen is assigned the value 100, most other gases
have a magnetic susceptibility of close to zero.

An oxygen sensor well suited for the ISA gas analyzer is the PM1116 paramagnetic oxygen
sensor from Servomex. In this sensor, a symmetrical non-uniform magnetic field is created. If
oxygen is present, it will be attracted into the strongest part of this field. Two nitrogen-filled
glass spheres are mounted on a rotating suspension within the magnetic field. Cnetrally on this

21-3
susoensionm a mirror is mounted. A light beam projected on the mirror is reflected onto a pair of
photecells. Oxygen attracted into the magnetic field will push the glass spheres from the
strongest part of the magnetic field, causing the suspension to rotate. When this ratation is
detected by the photocells, a signal is generated and passed to a feedback system. The feedback
system will pass a current around a wire mounted on the suspension, causing a restoring torque
that keeps the suspension in its original position. The current flowing around the wire is
measured, this current is directly proportional to the oxygen concentration.

The most important benefits of the paramagnetic oxygen sensor are:

• Fast rise time

• High stability and accuracy

• No chemicals to replace or renew

• Low maintenance requirements

21.7 Measurement Steps and Pre-use Check


(1) Measurement Steps
(a) Connect the AG module to the monitor.
(b) Connect Nomoline sampling line to the input interface of the ISA analyzer.
(c) Connect the interface cable of the ISA analyzer to AG socket on plug-in AG module.
(d) Start the monitor.
(e) Connect the outlet of the sample gas to the discharge system, or make the gas to flow
back to the patient circuit.
(f) If the LED is green, ISA Analyzer is available.
(g) Carry out pre-use check.
(h) If there is nothing wrong, start to monitor the AG.

Sampling line

Figure 21-3ISATMsidestream analyzer connection schematic

21-4
Figure 21-4IRMA™ mainstream analyzer connection schematic

(2) Pre-use Check


Before connecting the Nomoline sampling line to the breathing circuit, carry out the following
steps:
1. Connect the sampling line to the ISA gas inlet connector (LEGI).
2. Check whether the LEGI shows a steady green light (indicating the system is OK).
3. As for the ISA AG Module fitted with oxygen option: Check whether the O2 reading on the
host equipment is correct (21%).
4. Breathe to the sampling line, and check if valid CO2 waveforms and values are displayed on
the host monitoring equipment.
5. Use the fingertip to occlude the sampling line and wait for 10 seconds.
6. Check whether an occlusion alarm is displayed and that the LEGI shows a flashing red light.
7. If applicable: perform a tightness check of the patient circuit with the sampling line
attached.

Attention
 If the technical alarm message [NO O2 SENSOR] appears on the screen, please reconnect
the oxygen sensor.
 The end of the gas circuit adapter which connects the gas sampling line should point
upward so as to prevent the condensing water entering the gas sampling line and
blocking it up.

Warning

21-5
 Hang the external AG analyzer onto the AG bracket on the rear casing of the instrument;
prevent the dropping damage of the anesthesia module.
 Unless HME is used to protect the IRMA probe, the LED should face upward all the time
during IRMA probe placement.
 Do not pull the cable of ISA Sidestream Gas Analyzer.
 Do not operate the ISA Sidestream Gas Analyzer in the environment beyond the
designated working temperature.
 Make sure all connections are firm and reliable. Any leakage will result in the inclusion
of ambient air in the patient respiratory gas, which leads to a wrong reading.

21.8 AGSettings

21.8.1 Setting the Work Mode


(a) Select AA parameter area and a setup mene will be displayed.
(b) Select [WORK MODE]
(c) Select [STANDBY] or [MEASURE].
 [STANDBY] means under this work mode, gas pump will not work in order to prolong its
service life and [AG MODULE STANDY…] will appear in the prompt message area.
 [MEASURE] means under this work mode, the LED of AG module is steady green and AG
module will send the measured date to the monitor. Once the AG module is connected
to the monitor, its work mode auto turns to measurement. But the user must make sure
that the AG module's workmode is under measurement before AG measurement.

21.8.2 Setting Gas Compensation


This option is in default state because the oxygen sensor provides oxygen compensation
automatically according to the altitude. Foroxygen-free module, compensation level can be set
manually according to the altitude

(a) For example, Select AA parameter area, in the [AA SETUP] menu, select [O2 COMPENSATE]→
[HIGH], [MED](Medium) or [LOW].
 HIGH: The system default oxygen compensation is 85%;
 MED: The system default oxygen compensation is 50%;
 LOW: The system default oxygen compensation is 21%;
(b) For example, Select [CO2 (AG) ] parameter area, in the [CO2 SETUP] menu, select [N2O
COMPENSATE]→ select [ON] or [OFF].
 [N2O COMPENSATE]: It is compensated automatically by the anesthesia module at
starting.

Warning
 Please set the gas compensation based on actual circumstances; otherwise the measured
result may seriously deviate from the actual value, which will result in a wrong

21-6
diagnosis.

21.8.3 Setting the Pressure Unit


(a) Select [CO2 (AG)] parameter area and the [CO2 SETUP] menu will be displayed.
(b) Select [UNIT];
(c) Select [mmHg] or [KPa];

21.8.4 Setting the Apnea Alarm Time


(a) Select CO2 (AG) parameter area amd the [CO2 SETUP] menu will be displayed;

(b) Select [APNEA ALM].

(c) Foradult: select [10S], [15S], [20S], [25S], [30S], [35S], [40S] or [NO];for
pediatric/neonate:select [10S], [15S], [20S] or [NO].

 [10S]: It indicates the apnea alarm time; when apnea occurs to the patient for 10s and
the CO2alarm functionis activated, the monitor will trigger an alarm;and so on.

 [NO]: means apnea alarm function is disabled.

21.9 Zeroing
An infrared gas analyzer needs to establish a zero reference level for CO2, N2O and anesthetic
gas measurement. This zero calibration is called as “zeroing” here.

 Automatic Zeroing
The ISA sidestream gas analyzer performs zeroing automatically by switching the gas sampling
from the respiratory circuit to the ambient air. The automatic zeroing is performed every 24
hours and takes less than 3 seconds for ISA CO2 gas analyzers and less than 10 seconds for ISA
multi gas analyzers. If the ISA sidestream gas analyzer is equipped with an oxygen sensor,
automatic zeroing also includes the room air calibration of the oxygen sensor.
 Manual Zeroing
Select AA parameter area, in the [AA SETUP] menu, select [ZERO CALIBRATING]. During zeroing,
make sure that the patient circuit is exposed to the ambient air (21% oxygen and 0% CO2) for
approximately 30 seconds; when this option issettable, zeroing can be executed.

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

21.10 AG Module Indicator Status


Overview of States Indicated by LEGI:
Indication Status

21-7
Steady green light System OK
1)
Blinking green light Zeroing
2)
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line
Note 1: Not applicable to IRMA OR.
Note 2: Only applicable to IRMA multigas probes.

21.11 Adverse Effects on Performance


(1) The following circumstances can cause known adverse effects on indicated performance:

 Quantitative effects of humidity or condensate.

 Quantitative effects of barametric pressure.

 Interfering gases or vapors.

 Other sources of interference.

(2) Gas measurement unit

Gas concentration is reported in units of volume percent. The concentration is definde as:

The total pressure of gas mixtureis measured by a cuvette pressure sensor in the ISA gas
analyzer.

For conversion to other units, the actural atmospheric pressure sent from the ISA sidestream
analyzer may be used, e.g.

CO2 (mmHg) = (CO2concentration) x (atmospheric pressure (kPa) from the ISA) x (750 / 100)

For example: 5.0 vol% CO2 @ 101.3 kPa 0.05 x 101.3 x 750 / 100 = 38 mmHg

(3) Effects of Humidity

The partial pressure and volume percentage of CO2, N2O, oxygen or an anesthetic gas
depend on the amount of water vapor in the measured gas. O2 measurement will be
calibrated to show 20.8 vol%, at actual ambient temperature and humidity level, instead of
showing actual partial pressure 20.8 vol% O2 corresponds to the actural O2 concentration

21-8
in room air with 0.7 vol% H2O concentration (at 1013hPa this equals for example 25°C and
23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g. all gases measured by
the IR-bench) will always show the actual partial pressure at the current humidity level.

In the alveoli of a patient, the breathing gas is saturated with water vapor at body
temperature (BPTS).

When the breathing gas is sampled, and passing the sampling line, the gas temperature will
get close to the ambient temperature before reaching the ISA sidestream gas analyzer. As
the Nomoline removed all condensed water, no water will reach the ISA gas analyzer. The
relative humidity of the sampled gas will be about 95%.

If CO2 valuesat BTPS are required, the following equation can be used:

Where:

Et CO2 = Et CO2 value sent from ISA [vol %]

Pamb = Ambient pressure sent from ISA [kPa]

3.8 = Typical partial pressure of water vapor condensed between the patient circuit and the
ISA[kPa]

Et CO2 (BTPS) = Et CO2 gas concentration at BTPS[vol%]

O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O

21.12 Safety Information

21.12.1 ISA Sidestream Gas Analyzer Safety Information

Warning
 The ISA sidestream gas analyzer is designed to be used by authorized or trained medical
personnel.
 Use only Nomoline sampling lines produced by PHASEIN.
 The ISA sidestream gas analyzer shall not be used with inflammable anesthetic agents.
 Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
 Do not reuse disposable sampling lines.
 Do not lift the ISA/host equipment by the sampling line as it could disconnect from the
ISA/host equipment, causing the the ISA/host equipment to fall on the patient.
 Used disposable sampling lines should be disposed of according to local regulations for
medical waste.

21-9
 Do not use adult/pediatric type sampling line configurations with infants, as this may
add dead space to the patient circuit.
 Do notuse infant type sampling line configurations with adults, as this may case
excessive flow resistance.
 Do not use the ISA sidestream gas analyzer with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
 Check that the gas sample flow is not too high for the present patient type.

 Since successful zeroing requires the presence of ambient air (21% oxygen and 0%
CO2), ensure that the ISA is placed in a well ventilated place. Avoid breathing near the
ISA sidestream gas analyzer before or during the zeroing procedure.
 The Nomoline sampling line and its interfaces are non-sterile devices. To avoid damage,
do not autoclave any part of the sampling line.
 Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 Measurements can be affected by mobile and RF communications equipment. Make sure
that the ISA gas analyzer is used in the electromagnetic environment specified in this
user manual.
 ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It must
be used in conjuction with other assessments of clinical signs and symptoms.
 Replace the sampling line if the sampling line input connector starts flashing red, or a
Nomoline occlusion message is displayed on the host equipment.
 No modification of this equipment is allowed without authorization of BPLMTPL. If this
equipment is modified, appropriate inspection and testing must be conducted to ensure
contuinued safe operation.
 ISAsidestream gas analyzersare not designed for MRI environments.
 During MRI scanning, the host equipment must be placed outside the MRI suite.
 Use of high frequency electrosurgical equipment in the vicinity of the ISA/host
equipment may produce interference and cause incorrect measurements.
 Do not use external ambient cooling of the ISA equipment.
 Do not apply negative pressure to the Nomoline (i.e. by a syringe) to remove
condensed water.
 Too strong positive or negative pressure in the patient circuit might affect the sample
flow.
 Strong scavenging suction pressure might affect the sample flow.
 Exhaust gases should be returned to the patient circuitor a scavenging system.
 Always use a bacteria filter on the evac side if sampled gas is intended to be re-breathed.
 Do not place the ISA gas analyzer in any position that might cause it to fall on the patient.

21-10
21.12.2 IRMA Mainstream Gas Analyzer Safety Information

Warning
 Do not use IRMA adult/pediatric airway adapter with infants as the adapter adds 6ml
space to the patient circuit.
 Replace the adapter if rainout/condensation occurs inside the airway adapter.
 Use only IRMA airway adapters made by PHASEIN.
 Do not use the IRMA infant airway adapter withadults as this may cause excessive flow
resistance.
 The host equipment shall have adequate protection against contact with live parts.
 Only adapter cables approved by PHASEIN AB can be used.
 There must be a warning implemented in the host equipment to indicate when demo
data is being displayed.
 The host equipment should be equipped with appropriate alarm systems to remind the
user of situations which could lead to death or serious deterioration of the patient’s
state of health.
 Alarm message corresponding to each bit in the IRMA statussummary field must be
implemented in the host equipment.
 The IRMA probe is not intended to be in patient contact.
 Incorrect probe zeroing will result in false gas readings.

 The IRMA probe is intended for use by authorized or trained medical personnel only.
 The IRMA probe must not be used with inflammable anesthetic agents.
 Disposable IRMA airway adapters shall not be reused. Reuse of the disposable adapter
can cause cross infection.
 Used airway adapters should be disposed of according to local regualtions for
medical waste.
 Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors shall be
disposed of in accordance with local regualtions for batteries
 Never try to open the oxygen sensor assembly. The oxygen sensor in the IRMA probe is a
disposable product and contains a caustic electrolyte and lead.
 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.
 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as
this may alllow patient secretions to block the adapter windows and result in incorrect
operation.
 Tokeep secretions and moisture from poolingon the windowsor oxygen sensor port,
always place 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

21-11
medications as this may affect the light transmission of the airway adapter windows.
 Incorrect agent selection by the user for IRMA OR (no automatic anesthetic agent
identification) will result in false anesthetic agent readings.
 Using IRMA OR (no automatic anesthetic agent identification) with gas mixtures
containing more than one agent will result in false anesthetic agent readings.
 Measurements can be affected by mobile and RF communications equipment. Make sure
that the ISA gas analyzer is used in the electromagnetic environment specified in this
user manual.
 Never sterilize or immerse the IRMA probe in liquid.
 The IRMA oxygen cell and the IRMA airway adapter are non-sterile devices. Do not
autoclave the devices as this will damage them.
 Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is
not in use.
 Do not apply tension to the sensor cable.
 Do not operate the device outside the temperature environment specified in this user
manual.
 (U.S.): Federal law restricts this device to sale by or on the order of a physician.

21.13 Airway Obstruction


When the gas airway is occluded, on the screen there will be such an alarm message as [AIRWAY
OCCLUSION].Under such a circumstance, replace the Nomoline sampling line.

Warning
 Do not use the ISA sidestream gas analyzer with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.

21.14 Discharging Waste Gases


When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from
polluting the operating room. Usually the gas outlet should be connected to (via the gas
discharging tube connected to the sample gas outlet of the host equipment) a discharging
system (used for discharging collected gases) or the patient circuit (used for the back flow of
collected gases).

Warning
 Anesthetics: when perform measurement on the patients who are receiving or have
recently received anesthetics, connect the outlet on the module to a waste gas
processing system, anesthesia machine or ventilator, so as to prevent medical staff from
inhaling the anesthetic.

21.15 Consumables

21-12
The Nomoline sampling is non-reusable.
Every two weeks or whenever [SAMPLING LINE CLOGGED] alarm message appears, whichever
comes first, the Nomoline sampling line should be replaced.

21.16 Safety Symbol


Safety Signal Word, Color Code
Description
Symbol and Description Text Format

“Warning” refers to a dangerous situation which


Warning: Supplementary may cause personal injury or death. A warning
text. symbol should be in conformity with: ISO
7010-W001.

Operating Instructions Consult operating instructions


ISA operating instructions Consult ISA operating instructions
Catalog number
Serial number
Lot No.:
The equipment shall not be taken into
Used by date [YYYY-MM-DD] operation after the date accompanying the
symbol.

Temperature limit

Pressure limit

Humidity limit

Do not re-use
Electrical and electronic equipment shall be
Waste electronic and
collected and recycled in
electrical equipment (WEEE)
accordance with Directive2002/96/EC

Containing Pb

Applicable to IRMAXL oxygen


sensors
IP classification indicating level of water
“Splash-proof”
protection
Level of protection Provide protection for tools and short wire ends
from water inflow and solid (>1mm).
foreign objects indicated by Provide protection for water spraying towards
IP classification all directions.
Warning (U.S.): Federal law restricts this device
Sold based on prescriptions to sale by or on the order of a (licensed
healthcare practitioner).
Recommended storage
Applicable to IRMA XL oxygen sensors
temperature

21-13
Below room temperature (23°C), the maximum
surface temperature of the probe is:
Limited temperature rise - IRMA CO2, 41°C/106°F
- IRMA OR,45°C/113°F
- IRMA AX+,50°C/122°F
Carbon dioxide ISA equipped to measure CO2 only

Multigas (AX+ or OR+) ISA equipped to measure multiple gases

PHASEIN Sigma multi-gas technology is applied


Sigma multigas technology
in the product
Gas inlet
Gas outlet (evac)
Illustrates the connection of Nomoline to
Connection to patient circuit
patient circuit

Connection to ISA Illustrates the connection of Nomoline to ISA

This product is a non-sterile device, free from


Non-sterile, Latex free
Latex.

21.17 Maintenance
The user should verify gas readings regularly; If finding any problem, please contact an engineer
of BPLMTPL for maintenance.

21.18 Patents and Trademarks


(1) Patent Statement
PHASEIN AB owns the following patents for relevant products described in this operating
instruction manual: SE519766; SE519779; SE523461; SE524086. Other patents are being
applied.
(2) Trademark
PHASEIN IRMA™, PHASEIN ISA™, PHASEIN XTP™, Sigma Multigas Technology™, LEGI™,
Nomoline™, IRMA EZ Integrator™, PHASEIN GasMaster™ and ISA MaintenanceMaster™ are
trademarks of PHASEIN AB.

Tygothane® is a registered trademark of Saint-Gobain Performance Plastics Corporation.

21-14
Chapter 22
IBP Monitoring
22.1 Overview
The invasive blood pressure(IBP) monitoring can usually monitor arterial blood pressure, central
venous pressure, pulmonary arterial pressure, left atrial pressure, right atrial pressure and
intracranial pressure.
The monitor can be directly used for measuring blood vessel pressure (diastolic pressure,
systolic pressure, average pressure).
Insert two IBP modules into the monitor at the same time and 4 channels of IBP
pressure waveforms will be displayed, as shown in the figure below:

Figure 22-1IBP display

22.2 Understanding IBP Modules

IBP1 socket

IBP2 socket

Figure 22-2 IBP module

22.3 Safety Information


Warning
 Make sure that the accessory to be used meets medical instrument safety
requirements.
 When connecting or using an accessory, you should avoid touching any metal part

22-1
connected to an electric appliance.
 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided conductive connection to the HF equipment to protect against burns to
the patient.
 Do not repeatedly use a disposable pressure transducer.
 Check whether the IBP cable is in good condition prior to monitoring. When you
discennect the IBP cable from the monitor, the monitor will trigger a technical alarm
and display alarm message “IBP SENSOR OFF” on the screen.
 If liquid (not the solution used for filling the pressure tube and transducer) is spattered
onto the monitoror accessory, especially when the liquid may enter the transducer or
monitor, please contact the maintenance department of the hospital.

Attention
 No matter a new sensor or a used sensor, it should be calibrated regularly in
accordance with hospital regulations.
 The user should zero the transducer before monitoring. During monitoring, the user
should maintain the pressure transducer and the heart at the same level all the time;
in order to prevent tube clogging, the user should keep injecting heparin saline
to wash the tube and maintain the unobstructed condition of the pressure
measurement path, and securely fixed the tube in order to prevent it from moving or
falling off, which will affect invasive blood pressure measurement.
 Only pressure transducers designated in this user manual can be used.

22.4 Steps of Monitoring


1. Insert the IBP module into the monitor.
2. Connect the IBP cable to the IBPsocket and turn on the monitor.
3. Prepare the pressure tube and transducer; the method is tofill up the system with
normal saline and make sure that there is no bubble in the tube system.
4. Connect the patient tube to the pressure tube and make sure that there is no air in the
tube and the pressure tube or the transducer.

Warning
 If there are bubbles in the pressure tube or the transducer, wash the system again with
the filled liquid.
5. Place the transducer at the same levelas the heart, approximately at middle axillary
line.
6. Select thepressure label;
7. Zero the sensor.

22-2
Figure 22-3IBP monitoring

22.5 IBP Pressure Zeroing


It is required to perform IBP pressure zeroing when the IBP1 and IBP2 modules are inserted into
the plug-in module slot and before IBP monitoring.

Attention
 The user should ensure that the pressure transducer has been zeroed before
measurement; otherwise the instrument will not have an effective zero
value, which will result in inaccurate measured data.

(a) Select IBP1 parameter area and [CH1:ART SETUP] menu will be displayed;
(b) Select [IBP PRESSURE ZERO];
(c) Or click [ZERO IBP] on-screen key and the monitor starts to perform IBP pressure zeroing;
Keys to IBP pressure zeroing:
1. Before starting zeroing, turn off the 3-way stop cock at the patient side.
2. Before starting zeroing, the pressure transducer must be exposed to the atmosphere.
3. The sensor must be placed at the same level as the heart, approximately at the middle
axillary line.
4. Zeroing should be carried prior to IBP monitoring, and at least once a day (zeroing must be
carried out every time the cable is pulled out).

22-3
Figure 22-4IBP zeroing connection schematic

22.6 IBPSettings

22.6.1 Changingthe Pressure Label


1. Select IBP waveform area and a waveform setup menu will be displayed;
2. Select [PRESS NAME];
3. Select a suitable pressure labelin the pop-up list box.
Pressure Label Description
ART Arterial pressure
PA Pulmonary arterial pressure
CVP Central venous pressure
RAP Right atrial pressure
LAP Left atrial pressure
ICP Intracranial pressure
P1/P2 Expansion pressure

22.6.2 Setting the Filter Mode


1. Select IBP waveform area and a waveform setup menu will be displayed;
2. Select [FILTER];
3. Select [SMOOTH] or[NORMAL].
 [SMOOTH] means the smoothest waveforms can be acquired.
 [NORMAL] means relatively smooth waveforms can be acquired.

22.6.3 Adusting the Pressure Scale


The user can upper scale and lower scale to change the size of IBP waveform.
(a) Select IBP waveform area and a waveform setup menu will be displayed;
(b) Select [HI] and [LO]and adjust the upper scale and lower scale respectively;
(c) [VAL] means the middle scale which is determined by the upper scale and lower scale.

22-4
22.6.4 Setting the Pressure Unit
(a) Select IBPparameter area and its setup menu will be displayed;
(b) Select [UNIT];
(c) Select [mmHg] or [kPa].

22-5
Chapter 23
ICG Monitoring
23.1 Overview
Impedance cardiography (ICG) measures the cardiac output and other hemodynamic parameters
using a safe and non-invasive method based on the thoracic electrical bio-impedance (TEB)
technology. As the velocity and volume of blood in the aorta change, the ICG measures the
changes in impedance from systole to diastole to calculate cardiac output and hemodynamic
parameters.
The ICG module transmits a high frequency AC signal into the chest of the human body and
derives impedance cardiography via the change of impedance produced by the periodical
change of blood flow.

23.2 ICG Display


The monitor can display 1 channel of chest impedance waveform and ICG parameter including
one primary parameter CI and 2 secondary parameters, as shown in the figure below:

ICG waveform Primary parameter Secondary


parameter
Figure 23-1 ICG Display

23.3 Understanding the ICG Module

Indicator

ICG socket

Figure 23-2ICG module

23-1
23.4 Safety Information
Warning
 The ICG monitoring is applicable only to adults with height ranging from 122cm to
229cm and weight ranging from 30kg (67lb) to 159kg (341lb).
 The ICG monitoring cannot be used on those patients with a minute ventilation (MV)
pacemaker when the MV sensor function is enabled.
 During ICG monitoring, the conductive gel on the sensors should not contact any
conductive substance.
 The ICG sensors can be used on one patient only.

23.5 ICG Parameters

23.5.1 Hemodynamic Parameters


(a) Select ICG parameter area and the [ICG SETUP] menu will be displayed;
(b) Select [Hemodynamic] to view the measured value of each hemodynamic parameter;
The [Hemodynamic] menu displays thehemodynamic parameters as shown in the following
table:
C.O. Cardiac output (_I and _Z)
C.I. Cardiac index (_I and _Z)

SI Stroke volume index (_I and _Z)

SV Stroke output volume (_I and _Z)

SVR Systemic vascular resistance (_I and _Z)

SVRI Systemic vascular resistance index (_I and _Z)


HR Heart rate
TFC Thoracic fluid content
QI Quality index
DO2I Oxygen delivery index
This HR value is not acquired by the ECG module, but directly acquired by
the ICG module.

23.5.2 List of Hemodynamic Parameters


Please refer to the Hemodynamic Calculationfor the list of hemodynamic parameters.

23.6 Influencing Factors


The following circumstances may affect ICG monitoring:
 Septic shock;
 Aortic valve regurgitation
 Severe hypertension (mean arterial pressure> 130mmHg);
 The patient’s height and weight exceed the designated ranges;
 Aortic balloon pumps insertion;
23-2
 With excessive patient movements such as shivering;
 Signal interference caused by cable connections or power cords;
 All sorts of thoracotomy operations which cause the changes of normal chest blood or
electric current.

23.7 Steps of Monitoring


(1) Start the monitor.
(2) Insert the ICG module into the monitor.the ICG module indicator illuminates, which means
the module has been successfully connected to the monitor; otherwise, reinsert the ICG
module.
(3) Access [ICG SETUP] menu and enter the detailed patient information in the menu [PATIENT
INFO SET].
(4) Connect the patient cable to the ICG module;
(5) Prepare the patient’s skin;
(6) Attach the sensors to the patient;
(7) Connect the patient cable to sensors on the patient.

23.7.1 Skin Preparation


Proper skin preparation is necessary for good signal quality at the sensor, as the skin is a poor
conductor of electricity.
First select the skin areas for the sensors and then do the following procedures:
(1) Shave the body hair from skin at the chosen areas;
(2) Gently rub the skin surfaceso as to remove dead skin cells;
(3) Thoroughly clean the skin at the chosen sits in order to make sure that allthe oily residuals,
dead cells and abrasive material are completely removed. Residual abrasive particles will
become the source of interference;
(4) Before applying the sensors, please thoroughly dry the skin.

23.7.2 Placing the Sensors


In order to acquire good signal quality and accurate data, it is very important to place the sensors
at the chosen sits appropriately.
(1) Vertically place the neck sensors right underneath the earlobes at both side of the neck;
(2) Place the upper chest sensors on the intersections of the xiphoid horizontal plane and the
midaxillary lines at the both sides of the chest;
(3) These two groups of sensors must be placed at directly opposite positions (180°).

23-3
Figure 23-1 Placement of ICG sensors

23.8 ICG Settings


23.8.1 Entering Patient Information
(a) Select ICG parameter area and the[ICG SETUP] menu will be displayed;
(b) Select [PATIENT INFO SET] andenter the detailed patient information, especillay for the
following items:
 Enter the[HEIGHT(cm)]and [WEIGHT(Kg)]. The height and weight are necessary
parameters for ICG measurement. When connecting the ICG module, the system will
automatically check these two parameters.If they are not entered or the entered values
do not meet the requirements, the system will display corresponding prompts.
 Enter the [CVP(mmHg)] and [PAOP(mmHg)]. The central venous
pressure(CVP)andpulmonary arterial occlusionpressure(PAOP) can be obtainedfrom the
IBP module. If they cannot be obtained from the IBP module, the user needs to enter
them manually. The valid range is 0~100mmHg.
 Enter [BEAT]. Since the ICG values are obtained by averaging the measurement results
of multiple heartbeats, the user needs to enter the mean heartbeat manually if it cannot
be obtained from the ECG. The smaller this value is, the greater influence on ICG
value will be. The greater this value is, the smaller influence on the ICG value will be;
 Enter [UPDATE](Data Updating Rate) and available options include [5], [10], [20], [30],
[40], [50]or [60].

23.8.2 Changing the Secondary Parameter


(a) Select ICG] parameter area the [ICG SETUP] menu will be displayed;
(b) Select [SECONDARY PARAM];
(c) Select [C.O.], [SV], [QI], [DO2I], [SI], [SVR] or [SVRI];

23-4
23.9 Trouble Shooting
Problem Possible causes OptionalSolution
There is a weak or The sensors are not Place the electrode onto the human body
no ECG signal properly placed onto again; then press the “Submit
the patient。 Patient/System Data” button; replace the
simulator battery, if the problem is still there,
call technical service.
ECG or ICG display Data reset Circulate the power or click the “Submit
stops Patient/System Data” button.
If the problem is still there, call technical
service.
The electrode The electrode is not Place the electrode onto the human body
lead condition is properly placed onto again; then press the “Submit
“Bad” the human body, needs Patient/System Data” button; use a different
to be replaced. external patient cable; if the problem is still
there, call technical service.

23-5
Chapter 24
C.O. Monitoring
24.1 Overview
The cardiac output (C.O.) measurement invasive measures cardiac output and other
hemodynamic parameters through the routine thermo dilution method. The monitor can
measure the blood temperature, calculate the cardiac output and carry out the hemodynamic
calculation.

24.2 C.O. Display

Body temperature

Cardiac output

Figure 24-1 C.O. display

24.3 Understanding C.O. Module

Indicator

C.O. socket

Figure 24-2 C.O. Module

24.4 Safety Information


Warning
 Make sure that the accessories never come into contact with any conductive parts.
 Select the injection volume and calculation coefficient corresponding to the drift
catheter used. If the floating tube is replaced, please enter the calculation coefficient of
the drift catheter according to the accompanying operating instruction manual.

24-1
 Only use the cable, drift catheter and probe designated by BPLMTPL.

Attention
 The settings cannot be changed during C.O. measurement.

24.5 Measurement Principle


The C.O measurements to enable the drift catheter to enter from the vein to the pulmonary
artery, and then inject a certain amount of low-temperature injection via the drift catheter. When
the injection and the cardiac output blood are mixed, the blood temperature will change. By
measuring the blood temperature change curve before and after the injection, the cardiac output
can be obtained according to the principle of thermal balance.
In C.O measurement, you can select the room-temperature injection or ice-water injection. The
monitor can save data of 6 measurements at most. If there are more than 6 measurements, the
earliest measured value will be deleted.

24.6 C.O. Settings

24.6.1 Setting the C.O. Coefficient


C.O. coefficient is the calculation coefficient related to the drift catheter and the injection
volume. When the drift catheter is replaced, such coefficient should be adjusted according to the
instructions of BPLMTPL. Valid range is 0~0.999.
1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [C.O. COEFFICIENT];
3) Select a suitable coefficient.

24.6.2 Changing the Source of Injection Temperature


1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [INJE TEMP SRC] (injection temperature source);
3) Select[MANUAL] or [AUTO]
 [MANUAL] means the injection temperature should be entered manually;
 [AUTO] means the real-time injection temperature can be acquired by the probe

24.6.3 Entering the Injection Temperature


When the [INJE TEMP SRC] (injection temperature source) is set to [MANUAL], the injection
temperature should be entered manually. The valid range is 0~27.0.
1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [INJE TEMP] (injection temperature);
3) Select a suitable value.

24-2
24.6.4 Changing the Temperature Unit
1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [TEMP UNIT]
3) Select [℃] or [℉]

24.6.5 Setting Measurement Interval


To avoid inaccurate measurements, a certain period of time should be allowed for the blood
temperature to become stable before starting a new measurement. Therefore it is necessary to
set the interval between two measurements.
1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [MEAS INTERVAL (S)];
3) Select the suitable interval;

24.6.6 Setting the Injection Volume


1) Select C.O. parameter area and the [C.O. SETUP] menu will be displayed;
2) Select [INJE VOLUME] (injection volume);
3) Select the suitable injection volume. Valid range is0.1~10 ml.

24.7 Steps of C.O. Measurement


(1) Connect the C.O. cable to the C.O. module.
(2) Connect the C.O. cable, drift catheter, injector and other components as shown in the
following figure:

Figure 24-3 C.O. measurement connection schematic

24-3
(3) Access [PATIENT INFO] menu and confirm the height and weight of the patient.
(4) Access [C.O.SETUP] menu and set relevant C.O. information. Refer to C.O. Settings in this
chapter for detail.
(5) Select [C.O. MEASURE] and open the C.O. Measurement window, as shown below:

C.O. Coefficient and


Body Surface Area
Value

Measured Value and


C.O. Curve

Status Message
Area Function Button

Historical
measurements area

Figure 24-4C.O. measurement window

(6) When there is a status message “Ready for new measurement”, select the [Start] button and
perform the liquid injection immediately (not exceeding 4s), and the real-time thermal
dilution curve will be displayed in the C.O. measurement window.
(7) After each measurement, the measurement result will be displayed in the historical
measurements area. A new measurement can be performed only after the set interval.

Attention
 During injecting, 3-way stopcock to the drift catheter should be open and the 3-way
stopcock to the injection should be closed. After the measurement is completed, turn
off the 3-way stopcock to the drift catheter and turn on the 3-way stopcock to the
injection, then draw the injection into the syringe.
In addition, in the C.O. measurement window, you may also perform the following operations:
 Click [Start] and one C.O. measurement will start;
 Click [Stop] to stop the measurement if the measurement cannot be completed
automatically for a long time;
 Click [Cancel] to cancel the current C.O. measurement

24-4
 Click [Calculate] and a hemodynamic calculation window will be displayed.

24.8 Measuring the Blood Temperature


When no C.O. measurement is performed, the body temperature can be measured with a
temperature sensor at the distal end of the drift catheter in the pulmonary artery.
1. Insert the C.O. measurement catheter probe into the interface, and then blood
temperature will occur.
2. Set the alarm limit of the blood temperature.

24.9 Influencing Factors


(I) Factors that would cause measurement error:
 Patient’s movement during the measurement
 Anxious patient
 Changes in the heart rate and the rhythm
 Cardiac abnormality (e.g. valvular insufficiency)
 Saccule aeration during the measurement
 Improper catheter position
 Catheter damaged
 Improper injection time
 Incorrect and improper injection volume
(II) In order to obtain accurate C.O. measurement, it is suggested:
 The injection temperature should belower than the patient’s blood temperature.
 To inject the solution rapidly and steadily.
 To inject the solution at the end of expiration.
 To wait 1minute between two injections to allow baseline to stabilized.

24-5
Chapter 25
View Telemetry Data on Monitor (OPTIONAL FEATURE)
The data measured by the telemetry monitor can be viewed by the users on this bedside monitor.
When the telemetry monitor is connected with this bedside monitor, they are monitoring the
same patient and it is convenient to monitor patients when they go for a walk or do exercise
around hospital if our company’s central monitoring system is not applied in this hospital.

25.1 Connection
The telemetry monitor is connected to this monitor through wireless network. First, it is
necessary to build a wireless network.

1. Click the icon and the [NETWORK SET] menu will be displayed.

2. Set the [WIFI] to [ON];


3. Set the [NET BED](network bed number), [SERVICE PORT] and [Local IP] corresponding to
the telemetry monitor
4. Install the battery for telemetry monitor;
5. Set [MODE] to [SERVER] and the monitor switches to telemetry mode automatically, as
shown below. At this time, telemetry icons will be displayed above the first

ECG waveform: (Received signal strength) and (Battery power).

6. The telemetry monitor is connected with this monitor successfully and the patient can
be monitored.

Figure 25-1 Telemetry mode

WARNING
25-1
 Under telemetry mode, all the waveforms and data are displayed on the screen with a
delay of several seconds.
 Under telemetry mode, the ECG mode is unavailable.

25.2 Bedside Monitor Controls Telemetry Monitor


Users can change the settings of paired telemetry monitor on the monitor. The telemetry
monitor can only monitor ECG and SPO2 parameters, but other monitoring functions can be used
normally, such as:
1) Changing patient information;
2) Switching screens;
3) Setting the upper and lower alarm limits;
4) Alarm pause and alarm silence;
5) Record, ECG review, alarm events review and so on.

The icon “ ” will be displayed on the screen after pressing the nurse call key on the telemetry

monitor.
When the telemetry monitor adopts 12-lead ECG cable, the 12-lead ECG screen is available, as
shown below:

Figure 25-2 12-lead ECG screen

25-2
25.3 Cancel the Connection Between Beside Monitor and Telemetry

Monitor
There are two methods to cancel the connection between beside monitor and telemetry monitor:

Click the icon and the [NETWORK SET] menu will be displayed.

1) Set [WIFI] to [OFF];


2) Or set [MODE] to [CLIENT];
3) Then the connection between this beside monitor and telemetry monitor ends.

25-3
Appendix I

Product Configuration
Mode BPL ELITE VIEW EV100
Parameters

ECG 12 Lead √
NIBP √
RESP √
TEMP1 √
SpO2 √
Pulse rate √
EtCO2 ▲
IBP ▲
ICG ▲
C.O. ▲
AG ▲
ST segment analysis √
Arrhythmia analysis √
Drug calculation √
Hemodynamic calculation √
Ventilation calculation √
Oxygenation calculation √
Renal calculation √
216 mm Thermal Printer ▲
①“√” stands for the device with the function;
Note: ②Blank stands for the device without the function;
③”▲” stands for the function is optional to the device;
④The structure and the functions are the same except
for the appearance.

I-1
Appendix II

Accessories

Warning
 Only use the accessories designated in this user manual, or the monitor could be
damaged.
 To avoid cross infection, do not reuse any disposable accessory.
1. Standard Accessories:
No. Accessory No. Accessory Name Quantity
1 040-000008-00 Grounding cable 1
2 009-000074-00 Power cord 1
12-lead split-type defibrillation-proof 1
3 040-000481-00
ECG cable of American standard
4 040-000311-00 Adult SpO2sensor 1
5 040-000333-00 Adult electrode 1 Pack
6 040-000246-00 Adult temperature probe 1
7 040-000005-00 Adult blood pressure cuff 1
8 115-000012-00 Adult blood pressure tube 1
9 022-000091-00 Lithium battery 1

2. Optional Accessories:
No. Accessory No. Accessory Name Quantity

1 040-000062-00 Record paper 1 roll


2 040-000385-00 Coelom temperature probe 1
3 040-000025-00 Module fixing clamp 1
4 099-000004-00 Sensor for CO2 module 1
5 115-000718-00 Dual IBP plug-in module 1
6 115-001732-00 ICG module 1
Masimo SPO2 sensor 12p to 15p 1
7 046-000340-00
extension cable
8 040-000024-00 Airway adapter 1
9 040-000023-00 Cable fixing slot 1
10 040-000017-00 NOMOLINE sampling line 1
11 040-000360-00 IBP cable 1
12 040-000013-00 IBP pressure transducer 1
13 040-000461-00 ICG electrode 1
14 040-000460-00 ICG Cable 1

II-1
Appendix III

Product Specification

1. Monitor Type
Name type
Type of protection Class I with internal power supply.
against electric shock
Classification of BF applied part TEMP, SpO2, NIBP, CO2, AG
protection against CF applied part ECG, IBP, ICG, C.O.
electric shock
Classification by
medical device Class III
directive
Safety standard IEC 60601-1 and GB9706.1; IEC 60601-2-27 and GB 9706.25;
IEC 60601-2-30 and YY 0667; IEC 60601-2-49 and YY 0668;
IEC 60601-1-8 and YY 0709; ISO 21647 and YY 0601; YY 0670;
YY0782; YY0784; YY 1079; YY1139.
The degree of ingress
protection IPX1
The degree of safety in The device cannot be used in the case of flammable anesthetic
the condition of gas mixed with air and the mixture of oxygen or nitrous oxide.
flammable anesthetic
gas mixed with the
mixture like air, the
oxygen or nitrous oxide
mixture ( It’s NA )
Operation Mode Run the device continuously

2. Monitor Specifications
(1) Dimension and Weight
Name Specifications
Dimension and weight Dimension: 305mm±0.5mm (L) × 168mm±0.5mm (W) ×
308.4mm±0.5mm (H)
Weight: 2.8Kg (±0.1kg) (not including battery and parameter
module)
(2) Ambient Requirements
Name Specifications
Working Ambient 5℃~40℃
conditions temperature
Relative humidity <80%, non-condensable
Atmospheric 700hPa~1060hPa

III-1
pressure
Power supply Power voltage AC 100V-240V
Power frequency 50Hz/60Hz1Hz
Input current 1.9A~0.8A
Transport Please protect the Monitor against violent impact, vibration and water in
transport.
Storage The Monitor should be packed and stored in a well-ventilated
non-condensable room without corrosive gas (ambient temperature:
-20℃~55℃; relative humidity: <80%).
(3) Screen
Name Specifications
Display 12.1-inch TFT color screen (Touch Screen –Optional)
Display capacity Up to 12 channels of waveform
Resolution 800×600 pixels
(4) Recorder (Optional part for purchasing)
Name Specifications
Width of record paper 216mm
Paper speed 12.5/25/50 mm/s
Settings of real-time 3 sec,5 sec, 8 sec, continuous
record
Tracing waveform 6 channels at most under the monitoring mode, 12 channels at
most under ECG mode
Alarm Trigger record Yes
(5) Battery
Name Specifications
Battery specification 2600mAh, 14.8V lithium battery
Battery charging time At least 6h in normal use.
Battery working 2h normal use (with mini unit not connected) after a full charge;
time continue to work for 5 minutes after the first low-power alarm.
(6) Data Storage
Name Specification
Trend data Short trend 1h trend, resolution of 1s
Long trend 150h trend, resolution of 1min
Trend chart and 150 hours
trend table
Parameter alarm 200parameter alarms and related parameter waveform
Measured NIBP data 2,000 groups
Arrhythmia history 200 ARR events and related waveform, waveform length 8s, 16s, 32s.

ECG history Up to 7×24 hours full 12-lead ECG (8G SD card).

III-2
(7) ECG
Name Specifications
The ECG module complies with the YY1079 standards
12 leads (R, L, F, N, C1, C2, C3, C4, C5, C6 or RA, LA, LL, RL, V1, V2, V3,
Lead mode
V4, V5, V6)
Lead style I, II, III, avR, avL, avF, V1, V2, V3, V4, V5, V6
waveform 3 channels
Lead mode 5 leads (R, L, F, N, C or RA, LA, LL, RL, V)
Lead style I, II, III, avR, avL, avF, V
waveform 3 channel
Lead mode 3 leads (R, L, F or RA, LA, LL)
Lead style I, II, III
Waveform 1 channel
Overload Load 1V, power frequency, and differential-mode AC voltage for
protection 10s without damage (p-v).
Measurement of
breath and lead
<0.1µA
and active
silencing of noise
the range of
0.5mV~5mV
amplitude (p-v RTI)
The range of width
70ms~120ms
(monitor for adult)
The range of width
QRS wave (monitor for 40ms~120ms
amplitude and the neonate/ child )
range of interval a)Signal where amplitude (neonate/ child
operation mode is excluded ) (p-v RTI) is less
No response to the than or equal to 0.15mV
following signals b) Signal where amplitude (neonate/child
operation mode is excluded) for 1mV
and width for 10ms.
Power frequency’
>100µV(p-v)
voltage tolerance
range of
4mV
pyramidal wave
range of QRS wave 0.5 mV
Drifting tolerance
width of QRS wave 100ms
QRS wave’s
80bpm
repetitive rate
range of heart rate Range for adult 15~300bpm
measurement and Range for neonate/
15~350bpm
error child

III-3
<the larger one, either ±1%or the 1 bpm in
error
the 3leads, or 5leads, or 12leads mode
The widest range of
measurement in the 300 bpm
adult mode
The widest range of
measurement in the 350 bpm
neonate/child mode
Range of alarm adult 15~300bpm
limit neonate/ child 15~350bpm
Alarm resolution ±1bpm
Error of the alarm
±1bpm
limit
Frequency Surgical mode:1 Hz~20 Hz (-3.0dB~+0.4dB);
feature(the Monitoring mode:0.5 Hz~40 Hz (-3.0dB~+0.4dB);
bandwidth of ECG Diagnostic mode:0.05Hz~150 Hz (-3.0dB~+0.4dB);
channel) ST mode:0.05Hz~40Hz(-3.0dB~+0.4dB)
Starting time for
cardiac arrest, the
high heart rate
<10s
alarm and the
lower heart rate
alarm
amplitude of
±5mV;
inputting signal
Speed rate (RTI) 320mV/s;
offset voltage of
-300~+300mV;
direct current
Changes in
Dynamic range of ±10%;
outputting signal
inputting
Display of the
non-operation
condition (the
No declining below 50%
degree of
attenuating is
presented )
Input impedance No more than 20% signal attenuating (0.67Hz~40Hz)
System noise(p-v
<25µV
RTI)

Multichannel
<5%
crosstalk

Gain control and Gain selection Whole 2.5mm/mV, 5.0mm/mV,

III-4
stability display 10mm/mV,
20mm/mV, automatic
persistent
10mm/mV
display
gain control support manually replacement
gain variation in
Not more than 0.66% per min.
every minute
the general gain
Not more than ±10%
variation in an hour
Permanent
25mm/s
Selection of timing display
Selection of timing
reference non- persistent 12.5 mm/s, 25 mm/s, 50
reference and
display mm/s
accuracy
The maximum error
±10%.
of timing reference
Width of channels 30mm
Output display
Aspect rate 0.4s/mV
The general error of
the larger one, either ±20% or ±100µV
system
Sinusoidal
0.67~40Hz (attenuating-3dB )
input
Response
to
Frequency response the wide
Amplitude of the wave crest
pyramidal
attenuates from 0 to 25 Hz
Input signals wave
reconstructing inputting
accuracy 20ms
deviance
Response to the 0.3 Not more than 0.1mV
(RTI)
mV·s shock in its
slope rate
range Not more than 0.30mV/s
(RTI)
Electric
Not lower than ±5%
pole’s weight factor
hysteresis effect
Not more than 0.5mm
deviating 15 mm
Calibration
voltage’s 1mV ±5%
error
Common-mode
<1mV(p-v RTI).
rejection
Baseline control recovery time after
3s
and stability resetting

III-5
Drift rate within 10s 10µV/s
Baseline drift with
Not more than 500µV
1h
Baseline drift
below work Not more than50µV/℃
temperature
Extent: from ± 2mV to ± 700mV, width: from 0.1ms to 2.0ms, the
overshoot: less than 0.05ɑ, p- the settling time: less than 5μs and the
Pacemaker’s pulse
start of pulse, the rise and fall time, all of them don’t exceed 100μs;
suppression witho
the start time of pulse goes ahead of the QRS wave’s start time in or
ut overshoot
less than 40ms, that is to say, having the same pulse earlier than that
pacing pulses in 150ms to 250ms.
Inhibition of the
pacing pulse
Minimum input slew rate: 320mV/s RTI
detector for fast
ECG signal
Extent: from ±2MV Not lower than 0.2mV
to ±700MV, width:
from 0.5ms to
Display 2.0ms, the maximum
capabilities of rise time: 100µS and
pacing pulses the display of
ECG when 100
pacing pulses
appear per minute.
detecting range -2.0mV -- +2.0mV
ST-segment in the range of -0.8 mV~+0.8mV, the
detection detecting accuracy detecting error is the larger one, either
±0.02mV or ±10% (not preset in other ranges)
Resolution 0.01 mV
ST alarm range -2.0mV~+2.0mV(-20.0mm~+20.0mm);alarm resolution:0.1mV
Asystole, ventricular fibrillation / tachycardia, a single ventricular
ectopic, two ventricular ectopic, multiple ventricular ectopic,
Arrhythmia types ventricular ectopic bigeminy, trigeminy, the R- on -T (R ON T) , missed
beat, tachycardia, bradycardia, pacemaker not being captured and not
being paced
Leakage current < 10 uA
Electro surgery
The change of heart rate is not more than ±10% before the
interference
interference
suppression
Electrotome
Incision mode: 300W ; solidity mode: 100w, restoring time: ≤10s
protection

III-6
HR Calculation

Maximum T-wave When testing the HR as required in Section 4.1.2.1 c of YY 1079, the
inhibition cardio tachometer will inhibit all T waves with amplitude smaller
capability than that of 1.0mV/100ms QRS wave groups, 180ms T interval and
350ms Q-T interval.
HR calculation As required in Section 4.1.2.1 d of YY 1079, the HR is calculated like
this: if all of the last 3 RR intervals are longer than 1200ms, the
average of the last 4 RR intervals is the HR; in other cases, the
average of the last 12 RR intervals (with the longest interval and
shortest interval excluded) is the HR.
HR calculation As required in Section 4.1.2.1 e of YY 1079, the HR is displayed as
accuracy and follows after the 20s stable segment:
response to Figure 3 a) (bigeminy): 80±1bpm
arrhythmia Figure 3 b) (slowly varying bigeminy): 60±1bpm
Figure 3 c) (quickly varying bigeminy): 120±1bpm
Figure 3 d) (two-way contraction): 90±2bpm
Response time for As required in Section 4.1.2.1 f of YY 1079: the response time for a
HR change HR change from 80bpm to 120bpm or from 80bpm to 40bpm is less
than 10s.
Tachycardia alarm As required in Section 4.1.2.1 g of YY 1079, the waveform:
start time Figure 4 a) 1 - range: 10s
Figure 4 a) 0.5 - range: 10s
Figure 4 a) 2 - range: 10s
Figure 4 b) 1 - range: 10s
Figure 4 b) 0.5 - range: 10s
Figure 4 b) 2 - range: 10s
(8) Respiration
Name Specifications
Method Thoracic impedance

Adult 0rpm-120rpm
Detection and Range of detection
accuracy of breathing Neonate/child 0rpm-150rpm
rate Accuracy of
±1rpm
detection

Adult 0rpm-120rpm
Accuracy and error of
the alarm preset in
breathing rate
Neonate/child 0rpm-150rpm

III-7
Name Specifications
Error ±1rpm
Adult 10s~60s
Range and error of the Range
Neonate/child10s~20s
suffocation alarm
Error ±5s.
CVA recognition The Monitor can give an alarm when the HR conforms to the RR.
(9) NIBP
Name Specifications
The NIBP module complies with the YY0670 standards.
Way of measurement Self-oscillation method
Systolic
5.3-36kPa(40-270mmHg)
pressure
Range of
Diastolic
measurement 1.3-28.7kPa(10-215mmHg)
pressure
for Adult
Mean
2.7-31.3kPa(20-235mmHg)
pressure
Systolic
5.3-26.7kPa(40-200mmHg)
pressure
Range of
Diastolic
measurement 1.3-20kPa(10-150mmHg)
pressure
for child
Range and accuracy of Mean
2.7-22kPa(20-165mmHg)
measurement pressure
Systolic
5.3-18kPa(40-135mmHg)
Range of pressure
measurement Diastolic
1.3-13.3kPa(10-100mmHg)
for neonate pressure
Mean
2.7-14.7kPa(20-110mmHg)
pressure
5mmHg, when the non-invasive blood
Accuracy of pressure is beyond the range, the monitor still
measurement displays properly, but does not consider
accuracy.
Adult mode 300mmHg

Range and permissible 240mmHg


Child mode
deviation of
Neonate mode 150mmHg
overvoltage protection
Permissible
±3mmHg
deviation
Systolic 5.3~36kPa(40~270mmHg)
Range and
pressure
error of
adult Diastolic 1.3~28.7kPa(10~215mmHg)
the alarm
pressure
preset
Mean 2.7~31.3kPa(20~235mmHg)

III-8
pressure
Systolic 5.3~26.7kPa(40~200mmHg)
pressure
Diastolic 1.3~20kPa(10~150mmHg)
Child
pressure
Mean 2.7~22kPa(20~165mmHg)
pressure
Systolic 5.3~18kPa(40~135mmHg)
pressure
Diastolic 1.3~13.3kPa(10~100mmHg)
Newborn
pressure
Mean 2.7~14.7kPa(20~110mmHg)
pressure
Error The larger one, either ±0.1kPa or ±1mmHg
Manual and automatic (periodic ), continuous
Test interval of
1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240,
the manual
Mode of blood 480min
mode
pressure measurement
Continuous
mode(only for 5min
adult and child)
(10) SpO2
Name Specifications
Display 1%~100%
range
Display 1%
resolution
Measuring a) Digital SpO2 module: measuring range: 0%~100%; measuring accuracy:
accuracy ±2% (adult/infant, in non-motion state) or ±3% (newborn, in non-motion
state) within the measuring range of 70%~100%.
b) Masimo SpO2 module: measuring range: 1%~100%; measuring accuracy:
±2% (adult/infant, in non-motion state), ±3% (adult/infant, in motion state)
or ±3% (newborn, in motion or non-motion state) within the measuring
range of 70%~100%.
c) Nellcor SpO2 module: measuring range: 0%~100%; measuring accuracy:
±2% (adult/infant, in non-motion state) or ±3% (newborn, in non-motion
state) within the measuring range of 70%~100%.
d) The measuring accuracy within other measuring ranges is undefined.

Limit and a) Digital SpO2:0% ~100%;


Alarm preset
accuracy b) Masimo SpO2:1%~100%;
limit
of alarm c) Nellcor SpO2:1%~100%
preset
Accuracy ±1%

III-9
Perfusion The Masimo SpO2 transducer has the PI indication function.
Index (PI) Measurement range: 0.01 % 20 %.
Measurement accuracy: not defined.
Resolution: 0.01% (measurement range: 0.05%9.99%) or 0.1% (measurement
range: 10.0% 20.0%).

Note
 Confirmation about SpO2 measurement accuracy: accuracy of SpO2has been
confirmed in the comparison between experiment on human being and referential
value of arterial blood measured by CO-oxygen pressure gauge. Measurement results
of Pulse Oxygen Meter are subject to statistical distributions, which are, compared to
measurement results by CO-oxygen pressure gauge, expected to fall in designated
accuracy range with 2/3 results.
 Masimo SpO2 has passed the non-movement accuracy verification by compared to the
laboratory joint photoelectric oximeter and monitor in the human blood
research where healthy adult volunteers’ SpO2 value are at 70% to 100% under the
inducible hypoxic condition. This difference equals to ± one standard deviation, which
contains 68% of the sample.
 Masimo SpO2 has passed the non-movement accuracy verification in the human blood
research where healthy adult volunteers conduct friction motion or tapping motion at
2 to 4 Hz to induce a hypoxic condition. There is no repeated movement at range from
1 to 2 cm and frequency from 1 to 5 Hz. When set at inducible hypoxic condition (SpO2
70% ~100%) with range from 2 to 3 cm, the results should compare those of
laboratory joint photoelectric oximeter and monitor. This difference equals to ± one
standard deviation, which contains 68% of the sample.
(11) Pulse Rate
Name Specifications
Measuring a) Digital SpO2 module
range and Measuring range: 25bpm~250bpm; resolution: 1bpm; measuring error:
accuracy ±1bpm.
b) Masimo SpO2 module
Measuring range: 25bpm~240bpm; resolution: 1bpm; measuring error:
±3bpm (in motion state) or ±5bpm (in non-motion state).
c) Nellcor SpO2 module
Measuring range: 25bpm~250bpm; resolution: 1bpm; measuring error:
±3bpm (25bpm~250bpm)
Alarm a) Digital SPO2:25bpm~250bpm;
settings b) Masimo SPO2:25bpm~240bpm;
and c)Nellcor SPO2:25bpm~250bpm

III-10
resolution
of pulse
rate ±1bpm

(12) Body Temperature


Name Specifications
Range of
0℃~50℃
Range and accuracy measurement
of measurement for Error of
±0.1℃
measurement
Range of alarm
Stand accuracy of 0℃~50℃
set
alarm
Alarm resolution ±0.1℃
Display resolution 0.1C
Number of channel Double channels
(13) CO2
Name Specifications
The end-expiratory CO2 module complies with the YY0601 standards.
CO2 range of 0mmHg~150mmHg, 0%~19.7%, 0kPa~20kPa (at760mmHg).
measurement And air pressure is supplied by the mainframe.
CO2 resolution 1mmHg or 0.1kPa or 0.1%
±2mmHg between 0mmHg ~40mmHg ;
±5% between41mmHg ~70mmHg;
CO2accuracy
±8% between 71mmHg ~100mmHg;
±10% between 101mmHg~150mmHg
0mmHg ~ 150mmHg or 0kPa ~ 20kPa or 0% ~ 19.7%
Range of alarm set
(at760mmHg)
Alarm resolution ± 0.1kPa or ± 1mmHg
(14) IBP Specifications
Name Specifications
Number of IBP
4 channels
channel
Artery pressure, pulmonary artery pressure, central vein pressure,
Names of channel
right atrial pressure, left atrial pressure, intracranial pressure, plus
pressure
pressure.
ART 0~40kPa(0~300mmHg)
PA -0.8~16kPa(-6~120 mmHg)
Range and accuracy CVP -1.3~5.3kPa(-10~40mmHg)
of measurement RAP -1.3~5.3kPa(-10~40mmHg)
LAP -1.3~5.3kPa(-10~40mmHg)
ICP -1.3~5.3kPa (-10~40mmHg)

III-11
P1,P2 -6.6~40kPa(-50~300mmHg)
Range and accuracy
of IBP pressure ±1mmHg or ±2%, take the larger one (sensor error excluded)
measurement
Measurement range
-6.6kPa ~ +40kPa (-50mmHg ~ +300mmHg)
for static pressure
Display resolution
0.1kPaor 1mmHg
for static pressure
Measurement error ±1mmHg or ±2%, whichever is greater (transducer error not
for static pressure included)
ART 0 mmHg~300mmHg(0 kPa~40kPa)
PA -6 mmHg~120mmHg(-0.8 kPa~16kPa)

CVP,
RAP, -10 mmHg~40mmHg(-1.3 kPa~5.3kPa)
Range of IPB alarm LAP,
ICP

P1P2 -50 mmHg~300mmHg(-6.6 kPa~40kPa)

Resolution of IPB’s
±0.1 or ±1mmHg of the set value
alarm set
Sensitivity: 5V/V/mmHg
Pressure sensor
Range of impedance: 300~3000Ω
(15) AG Specifications
Name Specifications
The AG module complies with the YY0601 standards.
AG measurement Feature of infrared radiation absorption

AG preheat time < 20 sec


The following standard is suitable for a dry gas in 22 ± 5 °C and
1013 ± 40 hPa:
0% ~ 15%,15% ~ ±(2% + 2% of the reading)
CO2
25% unspecified
Range and accuracy N2O 0 to 100 % ±(2 % + 2% of the reading)
of AG measurement No definition of
Halothane unspecified
measurement range
±(0.15 % + 5% of the
Enflurane , 0 to 8 %
reading)
isoflurane 8 to 25 %
unspecified

III-12
±(0.15 % + 5% of the
0 to 10 %
Sevoflurane reading)
10 to 25 %
unspecified
0 to 22 % ±(0.15 % + 5% of the
Desflurane
22 to 25 % reading)unspecified
±(1 % + 2% of the
O2 0 to 100 %
reading)
Breathing
0 to 254rpm ±1 rpm
rate
CO2:1mmHg
AG resolution
AwRR:1rpm
CO2 , O2, N2O and one of five anesthetics (Enflurane, isoflurane,
AG gas
sevoflurane, halothane, desflurane)
Alarm
Range Step Accuracy
specification

EtCO2 0mmHg~76 mmHg 1mmHg ±1mmHg

FiCO2 0mmHg~76 mmHg 1mmHg ±1mmHg

AwRR 0rpm~100 rpm 1rpm ±1rpm

EtO2 18%~100% 1% ±1%


Range and accuracy
of AG alarm set
FiO2 18%~100% 1% ±1%

EtN2O 0%~100% 1% ±1%

FiN2O 0%~100% 1% ±1%

EtHal/EtEnf/EtI
So/EtSev/EtDe 0%~25% 0.1% ±0.1%
s
FiHal/FiEnf/FiI
So/FiSev/FiDe 0%~25% 0.1% ±0.1%
sv
(16) PHASEIN CO2 Gas Analyzer
Name Specifications
ISATM Sidestream analyzer
Measurement method infrared gas measurement
Apnea alarm time 10s, 15s, 20s, 25s, 30s, 35s, 40s.
General specification
Instruction Ultra-compact, low-flow sidestream gas analyzers with

III-13
integrated pump, zeroing valve and flow controller.
Operating temperature ISA AX+: 0~50°C(32~122°F), ISA OR+: 5~50°C(41~122°F)
Storage temperature -40~70°C(-40~158°F)
Operating humidity < 4kPa H2O(non-condensing)
(95% RH,30°C)
Operating atmospheric 52.5~120kPa (corresponding to max altitude at
pressure 4572m/15000 feet)
Water treatment Sampling tubes are patented waterproof tubes
Flow rate of sampling 50w rate of
Data output
Fi/ET value CO2、O2、N2O、anesthetic gases(halothane, enflurane,
isoflurane, sevoflurane, desflurane)
Waveform Displaying four waveforms of gas concentration at most
Diagnosis parameters Atmospheric pressure
Mark RESP detected, no RESP detected, replace O2 transducer,
check sampling tubes, accuracy undesignated and wrong
transducer
Gas analyzer
ISA transducer 2 to 9 channel NDIR type gas analyzer measuring at 4 to 10 µm
Compensation CO2.broadening effect
Calibration No need for calibration. There is an auto zeroing each time the
machine is started and then auto zeroing every 24 hours after
that (ISA CO2) and every 8 hours (ISA AX+/OR+).
Reheating time ISA CO2: < 10s, ISA AX+/OR+: <20s
Gas
Measurement range and Accuracy of all measured values is subject to standards of EN
accuracy under standard ISO 21647:2004 and EN 864:1996.
condition CO20-15vol% ±(0.2vol% + 2 % of the reading)
N2O0-100vol%±(2vol% + 2 % of the reading)
HAL, ISO, ENF 0-8vol%±(0.15vol% + 5 % of the reading)
SEV 0-10vol%±(0.15vol% + 5 % of the reading)
DES 0-22vol%±(0.15vol% + 5% of the reading)
O2 0-100vol%±(1vol% + 2 % of the reading)
Up-going time CO2≤ 250ms, N2O≤ 350ms, AG≤ 350ms, O2≤ 450ms
System overall response < 3s(2 meters sampling tube)
time
Respiratory detection Adaptive threshold, minimum 1vol% change in CO2
concentration
Respiratory frequency 0-150 times respiration/minute
Anesthetic gas threshold Main AG threshold (ISA OR+/AX+): 0.15vol%. When detecting
one kind of AG, though its concentration is less than
0.15vol%, the monitor would still report its concentration.

Interfering gas and vapor effects

III-14
Gas or vapour Gas level CO2 AG N2O
ISA CO2 ISA AX+
2) 1)
N2O 4) 60 vol% _1 _1
) )
_ _
HAL 4) 4 vol% _1 _1 _1 _1
) ) ) )

ENF, ISO, SEV 4) 5 vol% reading+8%3 _1 _1 _1


) ) ) )

DES 4) 15 vol% reading+12% _1 _1 _1


) ) )

3)

Xe (Xenon) 4) 80 vol% reading-10%3 _1 _1


) ) )

He (Helium) 4) 50 vol% reading-6%3 _1 _1


) ) )

Metered dose inhaler Metered dose inhaler


propellants propellants
C2H5OH (Ethanol) 4) 0.3 VOI% _1 _1 _1 _1
) ) ) )

C3H7OH (Isopropanol) 0.5 VOI% _1 _1 _1 _1


) ) ) )

4)
CH3COCH3 (Acetone) 1 vol% _1 _1 _1 _1
) ) ) )

4)

CH4 (Methane) 4) 3 vol% _1 _1 _1 _1


) ) ) )

CO (Carbon monoxide) 1 vol% _1 _1 _1 _1


) ) ) )

5)

NO (Nitrogen 0.02 vol% _1 _1 _1 _1


) ) ) )

monoxide) 5)

O2 5) 100 vol% _2 _2 _2 _2
) ) ) )

Note 1: Negligible interference, effect included in the specification “Accuracy, all


conditions” above.
Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect
included in the specification “Accuracy, all conditions” above.
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically
decreases the CO2 readings by 6%. This means that if measuring on a mixture containing
5.0vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically
be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 4: According to the EN ISO 21647:2004 standard.
Note 5: In addition to the EN ISO 21647:2004 standard.

Name Specifications
TM
IRMA (AG)mainstream gas analyzer
Measurement infrared gas measurement
method
Apnea alarm time 10s, 15s, 20s, 25s, 30s, 35s, 40s.
General specification

III-15
Description Ultra-compact, low-flow sidestream gas analyzers with integrated
pump, zeroing valve and flow controller.
Operating condition IRMACO2+: 0~40°C(32~104°F);
IRMA AX+: 10~40°C(50~104°F)
IRMA OR+: 10~35°C(50~95°F)
Storage condition -20~50°C(-4~122°F)
Humidity 10~95%(non-condensing)
Barometric pressure IRMA CO2/AX+: 52,5-120kPa (4572m); IRMA OR: 70-120kPa
(3048m)
Data output
Fi/ET CO2, O2, N2O, anesthetic gases(halothane, enflurane, isoflurane,
sevoflurane, desflurane)
Waveforms Displaying four waveforms of gas concentration at most
Diagnostic Atmospheric pressure
parameters
Flags RESP detected, no breaths detected, replace O2 sensor, check
sampling line, unspecified accuracy and sensor error
Gas analyzer
ISA sensor head 2 to 9 channel NDIR type gas analyzer measuring at 4 to 10 µm
Compensations Broadening effects of CO2.

Calibration No need for calibration. Room air calibration for O2 sensor when
replacing air adapter (less than 5s).
Warm-up time <20s (usually <10s)
Airway adapter
Adult/child 6ml ineffective volume
Infant 1ml ineffective volume
Gas
Measurement range Accuracy of all measured values is subject to standards of EN ISO
and accuracy under 21647:2004 and EN 864:1996.
standard condition Range
(IRMACO2)
CO2 0-15 vol%
(IRMA OR) (IRMA AX+)
CO2 0-10 vol% 0-10 vol%
0-15 vol%
O2 0-100vol%
N2O0-100 vol% 0-100 vol%
HAL, ISO, ENF 0-5vol%0-8 vol%
SEV 0-8 vol% 0-10 vol%
DES 0-18 vol% 0-22 vol%
Up-going time CO2≤90ms;N2O, AG≤300ms; O2≤300ms
System overall <1s
response time
Respiratory Adaptive threshold, minimum 1vol% CO2 change of
detection concentration

III-16
Respiratory 0-150 times respiration/minute
frequency
Anesthetic gas Main AG threshold: 0.15vol%, subordinate AG: 0.2vol%+10% of
threshold the main AG concentration, IRMA OR: 0.3vol%. When the
concentration exceeds the threshold, though lower than the
threshold, the monitor would still report its concentration.

Interfering gas and vapor effects


Gas or vapour Gas CO2 AG N
level ISA CO2 ISA AX+ 2
O
N2O 4) 60 vol% _1&2 _1&2 _1 _1
) ) ) )

HAL 4) 4 vol% _1 _1 _1 _1
) ) ) )

ENF, ISO, SEV 4) 5 vol% reading+8%5 _1 _1 _1


) ) ) )

DES 4) 15 vol% reading+12% _1 _1 _1


) ) )

5)

Xe (Xenon) 4) 80 vol% reading-10%5 _1 _1


) ) )

He (Helium) 4) 50 vol% reading-6%5 _1 _1


) ) )

Metered dose inhaler Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 VOI% _1 _1 _1 _1
) ) ) )

C3H7OH (Isopropanol) 0.5 VOI% _1 _1 _1 _1


) ) ) )

4)
CH3COCH3 (Acetone) 1 vol% _1 _1 _1 _1
) ) ) )

4)
CH4 (Methane) 4) 3 vol% _1 _1 _1 _1
) ) ) )

CO (Carbon monoxide) 1 vol% _1 _1 _1 _1


) ) ) )

5)
NO (Nitrogen 0.02 vol% _1 _1 _1 _1
) ) ) )

monoxide) 5)
O2 5) 100 vol% _1&2 _1&2 _2 _2
) ) ) )

Note 1: Negligible interference, effect included in the specification “Accuracy, all


conditions” above.
Note 2: For probes not measuring N2O andO2, the concentrations shall be set from host
according to the instructions in chapter 4.2 (SetN2O / SetO2), please refer to appendix B.
(IRMA CO2 measures neither N2O, nor O2. IRMA AX+ does not measure O2.)
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically
decreases the CO2 readings by 6%. This means that if measuring on a mixture containing
5.0 vol% CO2 and 50 vol% Helium, the measured CO2 concentration will typically be
(1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 3: According to the EN ISO 21647:2004 standard.
Note 4: In addition to the EN ISO 21647:2004 standard.

III-17
Electromagnetic compatibility (EMC)
(1) Electromagnetic compatibility
This section constitutes the guidance and PHASEIN’s declaration regarding
electromagnetic emission for ISA gas analyzer, IRMA sensor.
The ISA gas analyzer and IRMA sensor are intended for use in the electromagnetic
environment specified in the table below. Customers and end users of ISA gas analyzers
should assure that they are used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissionsCISPR1 1 Group 1 The ISA sensor uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissionsCISPR1 1 Class B The ISA sensor is suitable for use in all
Harmonic emissions N/A establishments including domestic and those
IEC61000-3-2 directly connected to the public low-voltage
Voltage fluctuations/ N/A power supply network that supplies buildings
flicker used for domestic purposes.
emissionsIEC61000-3-
3
(2) Electromagnetic immunity
This section constitutes the guidance and PHASEIN’s declaration regarding
electromagnetic emission for ISA gas analyzer, IRMA sensor.
The ISA gas analyzer and IRMA sensor are intended for use in the electromagnetic
environment specified in the table below. Customers and end users of ISA gas analyzers
should assure that they are used in such an environment.
Immunity test IEC 60601test Compliance Electromagnetic
level level environment-guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete
discharge (ESD) 8 kV air 8 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast 2kVfor power AC power quality should be that
transient/burst supply lines of a typical commercial or
N/A
IEC 61000-4-4 1 kVfor hospital environment.
input/output lines
Surge 1kV, line(s) to AC power quality should be that
IEC 61000-4-5 line(s) of a typical commercial or
N/A
2 kV, line(s) to hospital environment.
earth
Voltage dips, <5% UT1(>95%dip N/A The AC power quality should be
short in, UT),0.5 cycle the same as in a typical
interruptions commercial or hospital
and voltage 40% UT environment. If the user of the

III-18
variations on (60%dip in, UT),5 ISA sensor requires continued
power supply cycles operation during power outages,
input lines the ISA sensor should be
IEC 61000-4-11 70% UT ( 30%dip powered by an uninterruptible
in, UT),25 cycles power supply or a battery.

<5% UT (>95%dip
in, UT),5s
Power 3 A/m 3A/m Power frequency magnetic
frequency fields should be at levels
(50/60 Hz) characteristic of a typical
magnetic field location in a typical commercial
IEC 61000-4-8 or hospital environment.
Portable and mobile RF
communications equipment
should be used no closer to any
part of the ISA sensor, including
3 Vrms cables, than the recommended
Conducted RF 150kHz~80MHz separation distance calculated
IEC 61000-4-6 from the equation applicable to
the frequency of the transmitter.
3 V/m Recommended separation
Radiated RF 80MHz to2.5GHz 10 Vrms distance:
IEC 61000-4-3 d= 0.35. p
d=0.18 p 80 MHz~800 MHz
20 V/m d = 0.35 p 800 MHz~ 2.5 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).

Field strengths from fixed RF


transmitters, as determined by
an electromagnetic site survey, a
should be less than the
compliance level in each
frequency range. B Interference
may occur in the vicinity of
equipment marked with the
following symbol:

1U T is the AC power before applying test.


Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site

III-19
survey should be considered. If the measured field strength in the location in which ISA is
used exceeds the applicable RF compliance level above, ISA should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating ISA.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
V/m.
(3) Separation distance to RF communications equipment
In this section the recommended separation distances between portable and mobile RF
communications equipment and the ISA gas analyzers and IRMA sensors are specified.
The ISA gas analyzer and IRMA transducer are intended for use in the electromagnetic
environment specified in the table below.
The customer or the user of ISA gas analyzers and IRMA sensor can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the ISA gas analyzer and IRMA
sensor as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter[m]
output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of transmitter d=0.35 p
d=0.18 p
d=0.35 p

[W]
0.01 0.035 0.018 0.035
0.1 0.11 0.057 0.11
1 0.35 0.18 0.35
10 1.1 0.57 1.1
100 3.5 1.8 3.5
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
(17) ICG Specifications
Name Specifications
ICG way of
indirect measurement by the impedance cardiogram
measurement
SV:5~250 ml/ beat
ICG range of
HR:40~250 bpm
measurement
C.O.:1.4~15L/min
SV: no definition
ICG accuracy HR: ±2bpm
C.O.: no definition

III-20
Alarm
specificatio range step
n
upper limit (lower limit +0.1) ~
15.0 L/min/m2
ICG range of alarm CI 01. L/min/m2
lower limit 0~ (upper limit -0.1)
set
L/min/m2
upper limit (lower limit + 0.1)
~150/KΩ
TFC 1 KΩ
lower limit 10~ (upper limit -1)

CI ±0.1L/min/m2
ICG accuracy of alarm
TFC ±1 KΩ

(18) C.O. specification


Name specification

C.O.: 0.1~20L/min
C.O. measurement
BT: 25~43℃
range
IT: 0~27℃

C.O.: The larger one, either ±he or ±or larger


Accuracy
BT、IT: ±T: ℃(not including sensor)

BT high limit (low limit+0.1)~43℃


Range of C.O. upper
BT low limit 23.0~(high limit-0.1)℃
and lower limit
Step 0.1℃

Accuracy of alarm ±0.1℃

III-21
Appendix IV

System Alarm Message


Here we only list the most important physiological and technical alarm messages. Some of the
alarm messages might not be listed.
XX represents some module names or physiological parameters in the system such as
HR,ST1,ST2,PVCs,RR,TEMP(includingTEMP1,TEMP2,TD),SpO2,PR,CO2(including
AwRR,INS),NIBP(NS,NM,ND),AG(includingCO2,O2,N2O,AA,HAL,ENF,ISO,SEV,DES),IBP,ICGand so on.
If the problem still exists after you implement the solution provided below, please contact our
maintenance staff.
(I) Physiological Alarm Message
Alarm Alarm
Source Cause Solution
Message Level
The XX value is higher
High XX Selectable than the upper alarm
Check the current condition of
limit.
XX the patient and whether the
The XX value is lower
alarm limit is appropriate.
Low XX Selectable than the lower alarm
limit.
The patient’s ECG Check the current condition of
Weak ECG signals are too weak to the patient and whether the
High
signal be analyzed by the electrode and lead are connected
system. properly.
Check the current condition of
Asystole occurs to the the patient and whether the
Asystole High
patient. electrode and lead are connected
properly.
Check the current condition of
Ventricular fibrillation or
the patient and whether the
VFIB/VTAC High tachycardia occurs to
electrode and lead are connected
ECG the patient.
properly.
Check the current condition of
Couplet occurs to the the patient and whether the
Couplet Selectable
patient. electrode and lead are connected
properly.
Check the current condition of
Bigeminy occurs to the the patient and whether the
Bigeminy Selectable
patient. electrode and lead are connected
properly.
Trigeminy occurs to the Check the current condition of
Trigeminy Selectable
patient. the patient and whether the

IV-1
Alarm Alarm
Source Cause Solution
Message Level
electrode and lead are connected
properly.
Check the current condition of
R ON T occurs to the the patient and whether the
R ON T Selectable
patient. electrode and lead are connected
properly.
Check the current condition of
PVC occurs to the the patient and whether the
PVC Selectable
patient. electrode and lead are connected
properly.
Check the current condition of
Tachycardia occurs to the patient and whether the
Tachy Selectable
the patient. electrode and lead are connected
properly.
Check the current condition of
Bradycardia occurs to the patient and whether the
Brady Selectable
the patient. electrode and lead are connected
properly.
Check the current condition of
VT>2 occurs to the the patient and whether the
VT>2 Selectable
patient. electrode and lead are connected
properly.
Check the current condition of
Missed Missed beats occur to the patient and whether the
Selectable
beats the patient. electrode and lead are connected
properly.
Check the current condition of
The pacemaker is not the patient and whether the
PNP Selectable
paced. electrode, lead and pacemaker
are connected properly.
Check the current condition of
Pacemaker signals are the patient and whether the
PNC Selectable
not captured. electrode and lead are connected
properly.
The patient’s pulse Check the current condition of
No pulse signals are too weak to the patient and whether the
SpO2 High
signal be analyzed by the transducer is connected
system. properly.
The patient’s respiration
Check the current condition of
RESP signals are too weak to
RESP High the patient and whether the lead
asphyxia be analyzed by the
is connected properly.
system.

IV-2
Alarm Alarm
Source Cause Solution
Message Level
The patient’s respiration
Check the current condition of
RESP signals are too weak to
CO2 High the patient and whether the lead
asphyxia be analyzed by the
is connected properly.
system.
Alarm Press the mute/reset key again to
Others None The alarm is paused.
paused resume the alarm.

(II) Technical Alarm Message


Alarm
Source Alarm Message Cause Solution
Level
XX module An error occurs in the
initialization High XX module initializing
error process.
XX module The XX module fails to Restart the Monitor to try
communication High communicate with the again. If the error still
XX
stopped Monitor. exists, please contact us
The XX module fails to for service.
XX module
communicate with the
communication High
Monitor in a
error
normal way.
The alarm limit of the
XX alarm limit
XX High parameter XX is Contact us for service.
error
accidentally changed.
The measured value of
the parameter XX goes
XX measuring
XX High beyond the measuring Contact us for service.
over range
range provided by the
system.
FHR1 The FHR1 transducer is
Medium Check whether the
disconnected connected unreliably.
transducer is connected
FHR2 The FHR2 transducer is
Medium properly. If the problem
disconnected connected unreliably.
still exists, please contact
TOCO The TOCO transducer is
FETAL Medium us.
disconnected connected unreliably.
Adjust the transducer’s
Two transducers
position and check the
Medium acquire the same heart
Cross channel current condition of the
rate.
validation patient.
Check whether the ECG
ECG lead The ECG lead is
ECG Low lead is connected
disconnected connected unreliably.
properly.

IV-3
Alarm
Source Alarm Message Cause Solution
Level
ECG lead YY
disconnected
Check whether the ECG
(YY stands for The ECG lead YY is
Low lead YY is connected
V, LL, LA, RA, connected unreliably.
properly.
V1, V2, V3, V4,
V5 or V6)
Check whether the ECG
The ECG signal lead is connected properly
Strong ECG
High contains strong and whether the patient
interference
interfering signal. makes any major
movement.
The QRS wave The system self-learning
ARR is learning None template for ARR is finished. No solution is
analysis is forming. required.
Check whether the ECG
ECG lead The ECG lead is
Low lead is connected
disconnected connected unreliably.
properly.
The SpO2 transducer is Check whether the SpO2
SpO2 finger
Low disconnected from the transducer is connected
disconnected
finger. properly.
SpO2
transducer not Low
Check whether the SpO2
connected The SpO2 transducer is
transducer is connected
SpO2 connected unreliably.
properly.
transducer Low
disconnected
SpO2 If system resetting fails, or
NELLC error! There is a Nellcor the error still exists after
System is Low module error. The you restart the Monitor,
resetting system is resetting. please contact us for
service.
Check the current
The SpO2 transducer is
condition of the patient
connected improperly
Search pulse None and whether the SpO2
or the patient moves
transducer is connected
his/her arm.
properly.
TEMP1
transducer
The temperature Check whether the
disconnected Low
TEMP2 transducer is temperature transducer is
TEMP2 Low
connected unreliably. connected properly.
transducer
disconnected

IV-4
Alarm
Source Alarm Message Cause Solution
Level
Enable the reset function
An error occurs in the
NIBP self-check in the NIBP menu. If the
Low NIBP module
error error still exists, please
initializing process.
contact us for service.
Enable the reset function
NIBP The communication
in the NIBP menu. If the
communication Low part of the NIBP
error still exists, please
error module has a fault.
contact us for service.
NIBP cuff loose
The NIBP cuff is
or not Low Reconnect the NIBP cuff.
connected unreliably.
connected
Check the connection
The NIBP cuff is condition of each part or
Cuff inflation connected unreliably replace the NIBP cuff. If
Low
pipe leak air or the air circuit leaks the problem still exists,
air. please contact us for
service.
Check the connection
An error occurs in the
condition of each part or
measuring process. The
Air pressure replace the NIBP cuff. If
Low system fails to do
error the problem still exists,
NIBP measurement, analysis
please contact us for
and calculation.
service.
Check whether a correct
patient type is selected.
An error occurs in the
Check the connection
measuring process. The
condition of each part or
Weak signal Low system fails to do
replace the NIBP cuff. If
measurement, analysis
the problem still exists,
and calculation.
please contact us for
service.
Check the connection
An error occurs in the
condition of each part or
measuring process. The
Voltage over replace the NIBP cuff. If
Low system fails to do
range the problem still exists,
measurement, analysis
please contact us for
and calculation.
service.
Check the current
condition of the patient
The patient moves
Arm moved Low and the connection
his/her arm.
condition of each part, and
then restart the measuring

IV-5
Alarm
Source Alarm Message Cause Solution
Level
process. If the problem
still exists, please contact
us for service.
Check the current
condition of the patient
and whether the air circuit
Overpressure Probably the air circuit is blocked and then restart
Low
protected is folded. the measuring process. If
the problem still exists,
please contact us for
service.
Check the current
condition of the patient
An error occurs in the
and the connection
measuring process. The
Saturated condition of each part, and
Low system fails to do
signal then restart the measuring
measurement, analysis
process. If the problem
and calculation.
still exists, please contact
us for service.
Check the connection
condition of each part or
The NIBP air circuit replace the NIBP cuff. If
Pump leak air Low
leaks air. the problem still exists,
please contact us for
service.
Check the current
condition of the patient
An error occurs in the
and the connection
measuring process. The
NIBP system condition of each part, and
Low system fails to do
failure then restart the measuring
measurement, analysis
process. If the problem
and calculation.
still exists, please contact
us for service.
Check the current
condition of the patient
An error occurs in the
and the connection
measuring process. The
Measure timed condition of each part, and
Low system fails to do
out then restart the measuring
measurement, analysis
process. If the problem
and calculation.
still exists, please contact
us for service.
Wrong type of Low Probably the cuff does Check whether a correct

IV-6
Alarm
Source Alarm Message Cause Solution
Level
cuff not match the patient patient type is selected.
type you select. Check the connection
condition of each part or
replace the NIBP cuff. If
the problem still exists,
please contact us for
service.
Check the current
condition of the patient
An error occurs in the
and the connection
measuring process. The
NIBP measure condition of each part, and
Low system fails to do
failed then restart the measuring
measurement, analysis
process. If the problem
and calculation.
still exists, please contact
us for service.
Check whether the NIBP
air circuit is blocked and
Illegal reset occurs in
NIBP error and then restart the measuring
Low the NIBP measuring
reset process. If the error still
process.
exists, please contact us
for service.
Enable the reset function
NIBP An error occurs in the
in the NIBP menu. If the
self-checking Low NIBP module
error still exists, please
error initializing process.
contact us for service.
Restart the Monitor. If the
Key error High The system has a fault. problem still exists, please
contact us for service.
5V, high High
Restart the Monitor. If the
5V, low High The system power has
problem still exists, please
12V, high High a fault.
contact us for service.
12V, low High
Other Low battery
High
alarm voltage Connect the Monitor to
messages Battery work the AC power supply to
Medium
20min only The battery power is charge the battery. If the
Battery work low. problem still exists after
High
10min only 6-hour charging, please
Low battery contact us for service.
High
voltage
System is The battery power is so Connect the Monitor to
High
shutting down: low that the system is the AC power supply to

IV-7
Alarm
Source Alarm Message Cause Solution
Level
xxxS forced to shut down. charge the battery.
Low battery The battery voltage
Charge the battery.
voltage and power is low.
Check the battery. If the
Battery The battery is damaged
problem till exists, please
damaged or in poor contact.
contact us for service.
Check whether the
installed recording paper
A wrong type of paper
Check paper is of the type
is installed.
compatible with the
Monitor.
Find the correct
FHR1 signal The measuring signal is measuring position for
lost too weak. FHR1 and adjust the FHR1
transducer’s position.
Find the correct
FHR2 signal The measuring signal is measuring position for
lost too weak. FHR2 and adjust the FHR2
transducer’s position.

(III) System Prompt Message

Source Alarm Message Alarm Level Cause/Solution

Manual measure... None

Calibration... None

Leak measure… None

Manual reset... None The system prompt


message is given to tell
NIBP Continuous measure... None you the Monitor is
performing a certain
Press the start key! None function or operation.

Error reset None

Module reset... None

Auto measure... None

IV-8
Source Alarm Message Alarm Level Cause/Solution

Calibration finished None

None
Leak measure stopped

None
Measure finished

None
Overpressure protected

None
Reset failed

None
CO2 zero Zeroing, wait x S

None
ECG alarm off

Cannot monitor
High
patient when calibrated
None
RESP alarm off
Prompt
message for None
TEMP alarm off
disabled
alarm None
SpO2 alarm off

None
NIBP alarm off

None
CO2 alarm off

None
Load key module

Module None
Load ECG module
loading
prompt None
Load SpO2 module
message
None
Load NIBP module

Demo None

Screen is locked! Press any None


Other prompt key to unlock.
messages Screen is unlocked None
successfully!
None
System start time

None
Alarm pause Alarm paused manually Turn on the alarm again.

IV-9
Source Alarm Message Alarm Level Cause/Solution

None Exit the historical case


Case history Historical case information
information.
None
Alarm switch Alarm on None.

None
Alarm switch Alarm off Set “Alarm Switch” to “On”.

None Disable the alarm mute


Mute on Alarm mute on function to resume the
alarming function.
None
Mute off Alarm mute off None.

Paper used None Install the additional


No paper
up recording paper.
None Reconnect the TOCO
TOCO transducer not
TOCO transducer. If the error still
connected or unreliably
transducer exists, please contact us
connected
for service.
None Enable the timed
Monitoring
Timed monitoring finished monitoring function to
stopped
monitor a new patient.
None Enable the timed real-time
Timed real-time print
Print finished print function to print a
finished
new case.
Configuration None Make the Monitor return to
Configuration mode
mode the monitor mode.

IV-10
Appendix V

Guidance and Manufacturer’s Declaration


Guidance and manufacturer’s declaration–electromagnetic emissions The BPL ELITE VIEW
EV100 is intended for use in the electromagnetic environment specified below. The
customer or the user of the BPL ELITE VIEW EV100 should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR Group 1 The BPL ELITE VIEW EV100 uses RF energy only for
11 its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR Class A
11
Harmonic Class A
emissions IEC
61000-3-2
Voltage Complies
fluctuations/flicker
emissions IEC
61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity


The BPL ELITE VIEW EV100 is intended for use in the electromagnetic environment specified
below. The customer or the user of the BPL ELITE VIEW EV100 should assure that it is used in
such an environment.
Immunity IEC 60601 test Compliance Electromagnetic environment
test level level – guidance

Electrostatic ±6 kV contact ±8 ±4kV Contact Floors should be wood, concrete or


discharge kV air ±8kV Air ceramic tile. If floors are
(ESD) IEC covered with synthetic material, the
61000-4-2 relative humidity should be at least
30 %. If ESD interfere with the
operation of equipment, counter
measurements such as wrist strap,
grounding shall be considered.
Electrical fast ±2 kV for power ±2 kV for Power Mains power quality should be that
transient/burst supply lines ±1 supply lines of a typical commercial or hospital
IEC 61000-4-4 kV for environment.
input/output

V-1
lines

Surge IEC ±1 kV Mains power quality should be that


61000-4-5 differential ±1kV differential of a typical commercial or hospital
mode ±2 kV mode ±2kV environment.
common mode common mode
Voltage dips, <5 % UT (>95 % <5% UT for 0.5 Mains power quality should be that
short dip in UT) for 0,5 cycle 40% UT of a typical commercial or hospital
interruptions cycle 40 % UT for 5 cycles 70% environment. If the user of the BPL
and voltage (60 % dip in UT) UT for 25 cycles ELITE VIEW EV100 requires
variations on for 5 cycles <5% UT for 5 s continued operation during power
power supply 70 % UT (30 % mains interruptions, it is
input lines IEC dip in UT) for 25 recommended that the BPL ELITE
61000-4-11 cycles <5 % UT VIEW EV100 be powered from an
(>95 % dip in uninterruptible power supply or a
UT) for 5 sec battery.
Power 3 A/m 3 A/m Power frequency magnetic fields
frequency should be at levels characteristic of
(50/60 Hz) a typical location in a typical
magnetic field commercial or hospital
IEC 61000-4-8 environment.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for

equipment and systems that are not life-supporting


Guidance and manufacturer’s declaration – electromagnetic immunity The BPL
ELITE VIEW EV100 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BPL ELITE VIEW EV100 should assure that it is used in such
an environment.
Immunity IEC 60601 test Compliance Electromagnetic environment –
test level level guidance

V-2
Conducted 3 Vrms 3V Portable and mobile RF
RF IEC 150 kHz to 80 communications equipment should be
61000-4-6 MHz used no closer to any part of the BPL
ELITE VIEW EV100, including cables,
than the recommended separation
3V/m distance calculated from the equation
Radiated RF 3 V/m applicable to the frequency of the
IEC 80 MHz to 2,5 transmitter. Recommended separation
61000-4-3 GHz distance d = 1.2 p d = 1.2 p 80 MHz to
800 MHz d = 2.3 p 800 MHz to 2,5
GHz where P is the maximum output
power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m). Field strengths from fixed
RF transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range. Interference may
occur in the vicinity of equipment
marked with the following symbol:

Recommended separation distances between portable and mobile RF

communications equipment and the EQUIPMENT or SYSTEM – For EQUIPMENT and

SYSTEMS that are not LIFE-SUPPORTING


Recommended separation distances between Portable and mobile RF
communications equipment and the BPL ELITE VIEW EV100
The BPL ELITE VIEW EV100 is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the BPL
ELITE VIEW EV100 can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters) and the BPL ELITE VIEW EV100 as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power of
transmitter W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 p d = 1.2 p d = 2.3 p
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

V-3
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz
and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

V-4
V-5

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