Elite View Ev100
Elite View Ev100
Elite View Ev100
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.
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:
Contact Details
Marketed By:
BPL Medical Technologies Private Limited
11th KM, Bannerghatta Road,
Arekere, Bangalore – 560076
Karnataka, India
www.bplmedicaltechnologies.com
Preface
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
ECG/Monitoring mode
Equipotential grounding
switch key
Refer to instruction
USB
manual/booklet
Protection against
Freeze key vertically falling water
drops
(2) Package Symbols
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.
③ ②
2-1
① Display screen
Alarm pause key Press to put the alarm system into alarm paused
status
②
NIBP start key Press to start or stop the NIBP measurement.
Power ON/OFF
③
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
2-2
Alarm
④ Physiological alarm lamp(left); Technical alarm lamp (right)
lamp
Handle
Recorder slot
Sensor sockets
Figure 2-2 Left view (without modules and recorder plugged in)
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.
Recorder
Battery
Nameplate labeling
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.
Recorder indicator:
On: when an error occurred to the communication of the
ERROR indicator recorder or when the recorder door is open.
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
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
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”.
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.
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.
3-1
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.
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.
4-1
4.2.4 Adjusting Heartbeat Volume
There are two methods of adjusting heartbeat volume:
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.
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.
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.
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.
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
4-2
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.
Press [MAIN MENU] on-screen key and hold for more than three seconds until the turns to
Press and hold for more than three seconds until it turns to , which indicates the
touch screen is unlocked.
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.
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;
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].
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.
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.
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.
Click or to view the patient information not displayed in the current view;
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
(c) Select [BIG FONT] to open big font 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.
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.
6-4
Figure 4-7Cascade screen
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].
6-6
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.
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.
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.
7-2
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.
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.
When the alarm function of a certain parameter is deactivated, the icon will appear in
corresponding parameter area.
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:
7-4
Parameter
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].
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.
7-6
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:
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.
8-1
(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.
Warning
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.
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.
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:
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
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.
9-4
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.
9-5
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.
9-6
Uncompressed
waveform area
Compressed
waveform
area
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.
9-7
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:
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
Figure 10-1 Drug calculation window
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.
10-3
Figure 10-3 Hemodynamic calculation window
(3) Click or to show the calculated results of the output parameters not in current view
Height cm height
Weight kg weight
10-4
10.2.3 Output Parameters
Abbreviation Unit Full Spelling
SV ml stroke volume
EF % ejection fraction
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.
TV ml tidal volume
RQ / respiration quotient
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:
10-7
SaO2 % arterial oxygen saturation
Hb g/L hemoglobin
RQ / respiration quotient
Height cm height
Weight kg weight
10-8
Figure 9-6 Renal calculation window
(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.
Cr mol/L creatinine
10-9
Height cm height
Weight kg weight
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).
11-1
Components Selectable Cleaning Agents Selectable Disinfectants
Isopropyl alcohol(70%), Hydrogen
Isopropyl alcohol(70%),
Monitor peroxide
Glutaraldehyde solution(2%),
enclosure
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
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.
12-1
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.
NIBP calibration
ECG calibration
At least once a year or when you doubt the measured
IBP calibration value.
The performance of all measuring
functions
Cylinder
Patient
Monitoring
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.
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
insensitive or after changing the touch screen. Calibration methods are as follows:
4 Press the five symbols one by one following the indication on the screen
12-4
Chapter 13
Patient Safety
13.1 Safety Instruction
The design of the monitor complies with the international safety standard regarding medical
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.
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.
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
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
Recorder door
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.
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
14-3
Figure 14-4 Rhythm printing under ECG mode
14-4
Figure 14-5 VCG printing under 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.
1
6
8
7
Attention
The pacing signal detected will be shown as “ ”above the ECG waveform
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.
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
15-3
Red/green (left leg) electrodes - placed in the left lower abdomen.
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
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.
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
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.
15-7
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.
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.
Warning
The clinical significance of ST level change information provided by this monitor should
be decided by the physician.
R Wave
P T
Q
} DIF = ST Value
S
ST Measuring Point
BP: ISO
Initial Value +109 ms
-78 ms +109 ms
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.
15-11
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.
15-12
Figure 15-8 Arrhythmia 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.
16-1
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.
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
16-3
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).
Warning
If there is carbonyl hemoglobin, methemoglobin, or dye dilution chemical present,
the SpO2 value will deviate.
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.
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.
Y-type SpO2sensor
SpO2sensor jacket
17-3
Figure17-4 NeonatalSpO2sensor (2)
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
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
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.
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
1 2 3 4 5
6
8
10 9
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.
18-2
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:
Neonate 10~19 cm 8 cm
Adult 1 25~35 cm 14 cm 2m
Adult2 33~47 cm 17 cm
Leg 46~66 cm 21 cm
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
e) Middle of the cuff at the level of the right atrium of the heart
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.
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 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.
18-6
Chapter 19
Temperature Monitoring
19.1 Overview
This monitor has two temperature measurement channels; body temperature can be measured
by temperature probes.
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.
19-2
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.
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.
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.
20-2
(2) The schematic of connection of the sidestream module produced by the RESPIRONICS
company is shown in the figure below:
(3) The schematic of connection of the ISA™sidestream analyzer produced by the PHASEIN
company is shown in the figure below:
Sampling tube
(4) The schematic of connection of the IRMA™ mainstream analyzer produced by the PHASEIN
company is shown in the figure below:
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.
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.
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.
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.
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.
20-8
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.
20.10.3 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
AG module interface
AG/O2 general module
interface
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
The monitor can display measured waveforms and parameter values on the screen by AG
module, which include:
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.
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.
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.
Sampling line
21-4
Figure 21-4IRMA™ mainstream analyzer connection schematic
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
(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.
(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.
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.
21-7
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.
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
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:
3.8 = Typical partial pressure of water vapor condensed between the patient circuit and the
ISA[kPa]
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.
Warning
Do not use the ISA sidestream gas analyzer with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
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.
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
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
21.17 Maintenance
The user should verify gas readings regularly; If finding any problem, please contact an engineer
of BPLMTPL for maintenance.
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:
IBP1 socket
IBP2 socket
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.
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
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
22-4
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.
Indicator
ICG socket
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.
23-3
Figure 23-1 Placement of ICG sensors
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.
Body temperature
Cardiac output
Indicator
C.O. socket
24-1
Only use the cable, drift catheter and probe designated by BPLMTPL.
Attention
The settings cannot be changed during C.O. measurement.
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 [℉]
24-3
(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:
Status Message
Area Function Button
Historical
measurements area
(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.
24-5
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.
6. The telemetry monitor is connected with this monitor successfully and the patient can
be monitored.
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.
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:
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.
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
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/60Hz1Hz
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.
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
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
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.
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
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
Resolution of IPB’s
±0.1 or ±1mmHg of the set value
alarm set
Sensitivity: 5V/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
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
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.
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
) ) ) )
3)
4)
CH3COCH3 (Acetone) 1 vol% _1 _1 _1 _1
) ) ) )
4)
5)
monoxide) 5)
O2 5) 100 vol% _2 _2 _2 _2
) ) ) )
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.
HAL 4) 4 vol% _1 _1 _1 _1
) ) ) )
5)
Metered dose inhaler Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 VOI% _1 _1 _1 _1
) ) ) )
4)
CH3COCH3 (Acetone) 1 vol% _1 _1 _1 _1
) ) ) )
4)
CH4 (Methane) 4) 3 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
) ) ) )
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).
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)
KΩ
CI ±0.1L/min/m2
ICG accuracy of alarm
TFC ±1 KΩ
C.O.: 0.1~20L/min
C.O. measurement
BT: 25~43℃
range
IT: 0~27℃
III-21
Appendix IV
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.
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.
Calibration... None
IV-8
Source Alarm Message Alarm Level Cause/Solution
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
None
Alarm pause Alarm paused manually Turn on the alarm again.
IV-9
Source Alarm Message Alarm Level Cause/Solution
None
Alarm switch Alarm off Set “Alarm Switch” to “On”.
IV-10
Appendix V
V-1
lines
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:
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