Monitor Fetal C20 C29

User manual of C20/C29 Specialized Fetal&Maternal Monitor
Copyright
Shenzhen Comen Medical Instruments Co.,Ltd
Edition: D
Date: 2018/04
Part No: 046-000673-03
Product Name: Specialized Fetal &MaternalMonitor
Product Model: C20/C29
Statements
Shenzhen Comen Medical Instruments Co., Ltd. possesses the copyright of the non-published User Manual,
and has the right to handle it as confidential data.This User Manual is only used as the reference data for the
operation, maintenance and servicing of Comen products.
The others have no right to disclose the content of this User Manual to any third party.
This manual contains the proprietary information which is protected by copyright law. With copyright
reserved, any person shall not photocopy or duplicate any part of this manual or translate it into any other
language without the prior written permission of Comen Company.
Comen Company shall not assume responsibility for the incidental or consequential damages resulting from
the errors in this manual or from the provision, actual performance and use of this manual. Comen Company
shall not provide the proprietary right specified by patent law to any third party. Comen Company shall not
assume legal responsibility for the legal consequences resulting from violating the patent law and the rights
of any third party.
The content in this manual may be subject to change without further notice.
Guarantee
When all of the following conditions are satisfied, Comen Company shall be responsible for the safety,
reliability and performance of the product:
 The product is used according to the User Manual.
 The installation, maintenance and upgrading of the product are conducted by the personnel recognized
or authorized by Comen Company.
 The storage environment, working environment and electrical environment of the product comply with
the product specifications.
 The serial number lable or manufacturing mark of the product is clear and identifiable. It is verified by
Comen Company that this product is manufactured by it.
 The damages are caused by non-human factors (e.g. accidental fall and deliberate destruction).
The products that are within the warranty scope of Comen Company shall enjoy free service. As for the
products that are beyond the warranty scope, Comen Company shall charge for the service. If the products
are transported to Comen Company for maintenance, the user shall bear the freight (including the customs
expenses).
I
Return of products
If the products need to be returned to Comen Company, please follow the following steps:
Acquisition of the right to return the goods:Contact the after-sales department of Comen Company, tell it the
SN of the instrument made by Comen; theSN was printed on the equipment nameplate; if this SN is not
legible, the goods returned shall not be accepted. Please specify the SN and production date, and briefly
describe the reason for returning the goods.
After-sales Service Unit

Name:After-sales Service Department of Shenzhen Comen Medical Instrument Co., Ltd
Address: Floor 3, No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming sub-district, Guangming
New District, Shenzhen, 518106, Guangdong, P.R.China
Tel.: +86-0755-26408879
Fax: +86-0755-26431232
Customer Service Hotline: 4007009488
Postal Code: 518106
II
Preface
This manual provides the performance information, operating instructions and safety information regarding
the C20/C29 SpecializedFetal&Maternal Monitor (hereinafter referred to as “the monitor”) and can serve as
the start guide for new users.
Intended Audience
This usermanual is applicable to the professionals who are expected to have a working knowledge of
medical procedures, practices and terminology as required for monitoring of critically ill patients.
Figures
All the figures provided in this usermanual shall be for your reference only. The menus, options, values and
functions in the figures may not be entirely consistent with what you see from the monitor.
Conventions
 —>: This symbol is used to indicate the operating step.
 [Character]: is used to indicate the character string in the software.
 Italic text is used in this user manual to quote the referenced chapters or sections.
III
BLANK
IV
Contents
Chapter 1 Safety ..................................................................................................................................... 1-1
1.1 Safety Information...................................................................................................................... 1-1
1.2 Symbols ...................................................................................................................................... 1-3
Chapter 2 Overview ............................................................................................................................... 2-1
2.1 Intended Use ............................................................................................................................... 2-1
2.2 Components................................................................................................................................ 2-1
2.3 Contraindications ....................................................................................................................... 2-1
2.4 Appearance Introduction ............................................................................................................ 2-2
2.4.1 Front View...................................................................................................................... 2-2
2.4.2 LeftView ......................................................................................................................... 2-3
2.4.3 RightView....................................................................................................................... 2-4
2.4.4 RearView ........................................................................................................................ 2-5
2.4.5 Bottom View................................................................................................................... 2-6
2.4.6 Keyboard ........................................................................................................................ 2-6
2.5 On-screen Display ...................................................................................................................... 2-7
Chapter 3 Installation ............................................................................................................................ 3-1
3.1 Unpack and Check...................................................................................................................... 3-1
3.2 Connect the AC Power Cord ...................................................................................................... 3-1
3.3 Turn on the Monitor ................................................................................................................... 3-1
3.4 Connect the Sensors ................................................................................................................... 3-2
Chapter 4 Patient safety ......................................................................................................................... 4-1
4.1 Safety Instruction ....................................................................................................................... 4-1
4.2 Enviroment Requirements .......................................................................................................... 4-1
4.3 Grounding protection ................................................................................................................. 4-1
4.4 Equipotential Grounding ............................................................................................................ 4-2
4.5 Condensation .............................................................................................................................. 4-2
Chapter 5 Basic Operations ................................................................................................................... 5-1
5.1 Using the Main Menu ................................................................................................................. 5-1
5.2 General Settings ......................................................................................................................... 5-1
5.2.1 Setting the System time .................................................................................................. 5-1
5.2.2 Changing System Language ........................................................................................... 5-2
5.2.3 Adjusting Alarm Volume ................................................................................................ 5-2
5.2.4 AdjustingHeartbeat Volume ........................................................................................... 5-2
5.2.5 AdjustingFHR Volume ................................................................................................... 5-2
5.2.6 Adjusting Key Volume ................................................................................................... 5-2
5.2.7 Adjusting Screen Brightness .......................................................................................... 5-3
5.3 Module Setup ............................................................................................................................. 5-3
5.4 Monitor Information ................................................................................................................... 5-3
5.5 Demo Function ........................................................................................................................... 5-3
5.6 Locking the Touch Screen .......................................................................................................... 5-3
5.7 Network Settings ........................................................................................................................ 5-4
5.8 Frozing Waveform ...................................................................................................................... 5-4
Chapter 6 Patient Management ............................................................................................................ 6-1
6.1 Admitting Patient ....................................................................................................................... 6-1
6.2 Discharging Patient .................................................................................................................... 6-2
6.3 Patient Case Management .......................................................................................................... 6-2
6.3.1 Save Patient Case ........................................................................................................... 6-2
V
6.3.2 View Patient Case ........................................................................................................... 6-2

6.3.3 Import or Export Patient Case via USB Flash Disk ....................................................... 6-3
Chapter 7 User Screens .......................................................................................................................... 7-1
7.1 Overview .................................................................................................................................... 7-1
7.1.1 Fetal Monitoring Screen ................................................................................................. 7-1
7.1.2 Mother/Fetus Monitoring Screen ................................................................................... 7-2
7.1.3 Mother Monitoring Screen ............................................................................................. 7-2
7.1.4 List Screen ...................................................................................................................... 7-3
7.1.5 Trend Screen ................................................................................................................... 7-4
7.1.6 OxyCRGScreen .............................................................................................................. 7-5
7.1.7 Big FontScreen ............................................................................................................... 7-6
7.2 Swipe the Screen ........................................................................................................................ 7-6
7.3 Tailoring Your Screens ............................................................................................................... 7-7
7.3.1 Changing the Waveform Sweep Speed........................................................................... 7-7
7.3.2 Setting the DisplayColor ................................................................................................ 7-7
7.3.3 Setting the Waveform Display Style............................................................................... 7-7
7.3.4 Waveform Exchange ...................................................................................................... 7-7
Chapter 8 Alarm ..................................................................................................................................... 8-1
8.1 Alarm Type ................................................................................................................................. 8-1
8.2 Alarm Level................................................................................................................................ 8-1
8.3 Alarm Mode ............................................................................................................................... 8-2
8.3.1 Visual Alarm ................................................................................................................... 8-2
8.3.2 Audio Alarm ................................................................................................................... 8-2
8.3.3 Alarm Message ............................................................................................................... 8-3
8.3.4 Alarm Parameter Flashing .............................................................................................. 8-3
8.4 Adjusting Alarm Volume ............................................................................................................ 8-3
8.4.1 Adjusting the Minimum Alarm Volume ......................................................................... 8-3
8.4.2 Adusting the Alarm Volume ........................................................................................... 8-3
8.4.3 Setting the Reminder Tone ............................................................................................. 8-4
8.5 Alarm Settings ............................................................................................................................ 8-4
8.5.1 Setting the Alarm Level .................................................................................................. 8-4
8.5.2 Setting the Alarm Limit .................................................................................................. 8-5
8.5.3 Alarm Recording ............................................................................................................ 8-6
8.5.4 Setting the Alarm Delay Time ........................................................................................ 8-7
8.6 Pausing Alarms ........................................................................................................................... 8-7
8.6.1 Setting the Maximum Alarm Pause Time ....................................................................... 8-7
8.6.2 Setting the Alarm Pause Time ........................................................................................ 8-8
8.7 Switching off Alarms.................................................................................................................. 8-8
8.7.1 Switching off Individual Parameter Alarm ..................................................................... 8-8
8.7.2 Switching off All Parameter Alarms ............................................................................... 8-8
8.8 Latching Alarms ......................................................................................................................... 8-9
8.9 Alarm Reset ................................................................................................................................ 8-9
8.10 Alarm Presets ............................................................................................................................. 8-9
8.11 Check the Alarm System .......................................................................................................... 8-10
Chapter 9 Battery ................................................................................................................................... 9-1
9.1 Overview .................................................................................................................................... 9-1
9.2 Low Battery Alarm ..................................................................................................................... 9-1
9.3 Power Management .................................................................................................................... 9-1
9.4 Battery Installation ..................................................................................................................... 9-2
VI
9.5 Optimization and Check of Battery Performance....................................................................... 9-2

9.6 Battery Recycling ....................................................................................................................... 9-3
Chapter 10 Review ................................................................................................................................. 10-1
10.1 Trend GraphReview ................................................................................................................. 10-1
10.2 Trend Table Review.................................................................................................................. 10-2
10.3 NIBPMeasurement Review ...................................................................................................... 10-3
10.4 Alarm Event Review ................................................................................................................ 10-3
10.5 Waveform Review .................................................................................................................... 10-5
Chapter 11 Printing ................................................................................................................................ 11-1
11.1 Loading Recording Paper ......................................................................................................... 11-1
11.2 Printing ..................................................................................................................................... 11-2
11.2.1 Real-time Printing ........................................................................................................ 11-2
11.2.2 Frozen Printing ............................................................................................................. 11-2
11.2.3 Stored Patient Case Printing ......................................................................................... 11-3
11.2.4 Printing Settings ........................................................................................................... 11-3
11.3 Score Criterion ......................................................................................................................... 11-5
Chapter 12 Cleaningand Disinfection ................................................................................................... 12-1
12.1 Overview .................................................................................................................................. 12-1
12.2 Cleaning and Disinfection of the Monitor and Accessories ..................................................... 12-1
12.2.1 Cleaning and Disinfection of the Cuff.......................................................................... 12-3
12.2.2 Cleaning the Belt .......................................................................................................... 12-4
Chapter 13 Maintenance ........................................................................................................................ 13-1
13.1 Maintenance Check .................................................................................................................. 13-1
13.2 Maintenance Schedule .............................................................................................................. 13-1
13.3 ECG Calibration ....................................................................................................................... 13-2
13.4 NIBP Air Leakage Test ............................................................................................................. 13-2
13.5 NIBP Calibration ...................................................................................................................... 13-3
13.6 Touch Screen Calibration ......................................................................................................... 13-4
Chapter 14 Fetus Monitoring ................................................................................................................ 14-1
14.1 Difference between Antepartum and Intrapartum Monitor ...................................................... 14-1
14.1.1 Antepartum Monitoring Principles ............................................................................... 14-1
14.1.2 Terms about Fetus Monitoring ..................................................................................... 14-2
14.2 FHR Monitoring ....................................................................................................................... 14-2
14.2.1 Connect the FHR Transducer ....................................................................................... 14-2
14.2.2 Cross-Channel Verification .......................................................................................... 14-3
14.2.3 Trace Separation ........................................................................................................... 14-4
14.2.4 FHR Settings ................................................................................................................ 14-5
14.2.4.1 Setting the Source of Maternal Heart Rate ......................................................................... 14-5
14.2.4.2 Setting the FHR Sound Channel ......................................................................................... 14-5
14.3 TOCO Monitoring .................................................................................................................... 14-6
14.3.1 Connect the TOCO Transducer .................................................................................... 14-6
14.3.2 Setting the TOCO Zero Value....................................................................................... 14-7
14.4 FM Counting ............................................................................................................................ 14-7
14.4.1 Counting FM Manually ................................................................................................ 14-7
14.4.2 Counting FM Automatically ......................................................................................... 14-7
14.4.3 Setting the FM Sensitivity Threshold ........................................................................... 14-8
14.4.4 Setting the FM Counting Mode .................................................................................... 14-8
14.5 Fetus-awakening Vibratory Stimulator ..................................................................................... 14-9
10.4.1 Appearance Introduciton .............................................................................................. 14-9
VII
14.6 Timed Monitoring .................................................................................................................. 14-10

Chapter 15 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 .................................................................................................................. 15-3
15.4.1 ............................................................................................................................................ 15-3
15.4.1 Preparation ................................................................................................................... 15-3
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.................................................................................. 15-4
15.4.2.3 Placement of 5-lead ECG Electrodes.................................................................................. 15-4
15.4.2.4 Placement of Reformed 12-lead ECG Electrodes ............................................................... 15-6
15.4.2.5 ECG Lead Connection Recommended for Surgical Patients .............................................. 15-7
15.5 Waveform quality ..................................................................................................................... 15-7
15.6 ECG Settings ............................................................................................................................ 15-8
15.6.1 Setting the Lead Type................................................................................................... 15-8
15.6.2 Setting the Lead Name ................................................................................................. 15-8
15.6.3 Setting the Gain ............................................................................................................ 15-8
15.6.4 Setting the Filter Mode ................................................................................................. 15-9
15.6.5 Setting the Calculation Channel ................................................................................... 15-9
15.6.6 Setting the Heart Rate Source..................................................................................... 15-10
15.6.7 Setting the Notch ........................................................................................................ 15-10
15.7 ST Segment Analysis ............................................................................................................. 15-10
15.7.1 About ST Segment Analysis ...................................................................................... 15-10
15.7.2 Impact on ST Segment ............................................................................................... 15-10
15.7.3 Enabling ST Segment Analysis .................................................................................. 15-11
15.7.4 Adjusting the ST Segment Analysis Point ................................................................. 15-11
15.8 Arrhythmia Analysis............................................................................................................... 15-12
15.8.1 Enabling Arrhythmia Analysis ................................................................................... 15-13
15.8.2 Arrhythmia Alarm Settings ........................................................................................ 15-13
15.8.3 Setting the Tachycardia Threshold ............................................................................. 15-13
15.8.4 Arrhythmia Relearning ............................................................................................... 15-13
15.8.5 Arrhythmia Review .................................................................................................... 15-14
Chapter 16 RESP Monitoring ............................................................................................................... 16-1
16.1 Overview .................................................................................................................................. 16-1
16.2 RESP Display ........................................................................................................................... 16-1
16.3 Placing Electrodes for RESP Measurement ............................................................................. 16-1
16.4 RESP Settings........................................................................................................................... 16-2
16.4.1 Setting the Gain ............................................................................................................ 16-2
16.4.2 Setting theApneaAlarmTime ........................................................................................ 16-3
16.4.3 Setting the RESP Lead ................................................................................................. 16-3
16.4.4 Setting the RESP Filter ................................................................................................. 16-3
Chapter 17 SpO2 Monitoring................................................................................................................. 17-1
17.1 Overview .................................................................................................................................. 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/PR Display ..................................................................................................................... 17-2
VIII
17.4
MonitoringSteps ....................................................................................................................... 17-3
17.5
Measurement Limitations ......................................................................................................... 17-4
17.6
SpO2Settings............................................................................................................................. 17-5
17.6.1 Setting theIntelligent Alarm ......................................................................................... 17-5
17.6.2 Setting the Pulse Sound ................................................................................................ 17-6
17.6.3 Setting the Signal IQ .................................................................................................... 17-6
17.6.4 Setting the Average Time.............................................................................................. 17-6
17.6.5 Setting the Quick SpO2................................................................................................. 17-7
17.6.6 Setting the Calculation Sensitivity ............................................................................... 17-7
17.7 SpO2Accuracy Test ................................................................................................................... 17-7
17.8 Low Perfusion Accuracy Test ................................................................................................... 17-8
17.9 PR Accuracy Test ..................................................................................................................... 17-8
17.10 Masimo Information ............................................................................................................. 17-8
Chapter 18 NIBP Monitoring ................................................................................................................ 18-1
18.1 Overview .................................................................................................................................. 18-1
18.2 NIBP Display ........................................................................................................................... 18-1
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 TEMP Monitoring .............................................................................................................. 19-1
19.1 Overview .................................................................................................................................. 19-1
19.2 TEMP Display .......................................................................................................................... 19-1
19.4 Steps of TEMP Measurement ................................................................................................... 19-2
19.5 Setting the TEMP Unit ............................................................................................................. 19-2
Chapter 20 CO2 Monitoring .................................................................................................................. 20-1
20.1 Overview .................................................................................................................................. 20-1
20.2 Understanding CO2 Module ..................................................................................................... 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 Masimo Sidestream and Mainstream Analyzers ............................... 20-6
20.6.1 Measurement Steps....................................................................................................... 20-6
20.6.2 Pre-use Check ............................................................................................................... 20-6
20.7 CO2 Settings ............................................................................................................................. 20-7
20.7.1 Switching on/off CO2Module ....................................................................................... 20-7
20.7.2 Setting the Pressure Unit .............................................................................................. 20-7
20.7.3 Setting the Gas Compensation...................................................................................... 20-7
20.7.4 Setting the Apnea Alarm Time ..................................................................................... 20-8
20.7.5 Setting theAltitude ........................................................................................................ 20-8
20.7.6 Setting theBalance Gas ................................................................................................. 20-8
IX
20.8 Discharging Waste Gases ......................................................................................................... 20-8

20.9 Zeroing of RESPIRONICS Mainstream and Sidestream Module ............................................ 20-9
20.10 Masimo Mainstream and Sidestream Analyzer RelatedInformation .................................... 20-9
20.10.1 ISA Sidestream Gas Analyzer Safety Information ....................................................... 20-9
20.10.2 IRMA Mainstream Gas Analyzer Safety Information ................................................ 20-10
20.10.3 Zeroing ....................................................................................................................... 20-11
20.10.4 CO2 Module Indicator Status...................................................................................... 20-12
20.10.5 Safety SymbolInformation ......................................................................................... 20-12
20.10.6 Adverse Effects on Performance ................................................................................ 20-13
20.10.7 Airway Obstruction .................................................................................................... 20-14
20.10.8 Consumables .............................................................................................................. 20-14
20.10.9 Maintenance ............................................................................................................... 20-15
20.10.10 Patents and Trademarks ............................................................................................ 20-15
Appendix I Product Configuration ...............................................................................................I-1
Appendix II Accessories ................................................................................................................. II-1
Appendix III Product Specification.............................................................................................. III-1
Appendix IV System Alarm Message............................................................................................ IV-1
Appendix V Factory Default Settings ........................................................................................... V-1
Appendix VI EMC .......................................................................................................................... VI-1
X
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 relied on. If the alarm volume is set too
low or is 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 possible electric shock. The maintenance
and upgrading of this instrument must be conducted by the service personnel trained and
authorized by Comen.
 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 children.
 Do not use this instrument at the place where there are flammable articles such as anesthetic to
prevent explosion or fire from happening.
 Please carefully install the power lines and the cables for various accessories to avoid
1-1
Safety
entanglement or potential strangulation and keep the patient free from electrical interference.
 Do not use mobile phone near the monitorbecause the mobile phone will generate a very strong
radiation field and disturb the functions of the monitor.
 Warning—pacemaker patietns. Ratemeters may continue to count the pacemaker rate during
occurrences of cardiacarrest or some arrhythmias. Do not rely entirely upon heart rate meter
alarm signals. Keep pacemaker patients under close surveillance. See this manual fordisclosure
of the pacemaker pulse rejection capability of this instrument.
 The operators shall not touch the patients, tables and instruments during defibrillation.Before
reusing thecables, check whether their functionsare 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 electrosurgery 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.
 Conductive parts of electrodes and associated connectors for applied parts, including the
neutral electrode, should not contact any other conductive parts including earth.
 This is not a treatment device.
 Do not posit the equipment to make it difficult to operate the power plug which uses to isolate
the equipment circuits electrically from the supply mains.
 The installation and replacement of fuse should be performed by trained and qualified
serviceman.
 The use of this monitor is restricted to one patient at a time.
 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.
 After defibrillation, the ECG wave will recover within 5s, others will recover within 10s.
Caution
 To avoid damage to this instrument and guarantee patient safety, please use the accessories
specified 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 specified in the nameplate label or in
the user manual of this instrument.
 The expired instrument and accessories must be disposed of according to local relevant laws
and regulations or the rules and regulations of the hospital.
Attention
 Please install the equipment in a place that is convenient for observation, operation and
1-2
Safety
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.
 The expected service life of the monitor is 5 years.
 The analysis report is for reference only and the doctor should sign to ensure the correctness.
1.2 Symbols
(1) Product Symbols

Caution Manufacture date
CF applied part with
Serial number
defibrillation protection
Manufacturer Equipotential
BF applied part with

Network connection
defibrillation protection
Standby key Alarm indicator
Battery worke indicator Europeancommunity

representative
Refer to instruction
Battery charge indicator
manual/booklet
The transducers are dust-tight

and protected against the
AC power indicator
effects of temporary
immersionin water
ConformitéEuropéenneCo The moitor is protected against
mplies with medical device
vertically falling water drops
directive 93/42/EEC
Alarm pause Alarm reset
TOCO zero Print key
Warning: Only use the ECG cable provided by Comen. Other types of ECG cable
may decrease the defibrillation energy delivered to the patient.
(2) Package Symbols
This side up Maximum stacking layer
Fragile Keep dry
1-3
Chapter 2 Overview
The monitor is mainly used to monitor the fetus, the maternal uterine activity and vital signs. It can give
alarms for fetus parameters and maternal parameters, and display, save and record the relevant data
and waveform. Therefore, it is suitable for use in the parturient room, delivery room and antepartum
examination room.
The monitor is equipped with a 12.1 inch TFT touch screen. All operations on the monitor can be performed
by keys, control knob and touch screen.
2.1 Intended Use
The monitor is applicable to monitoring FHR, FM and TOCO as well as pregnant woman’s and patient’s
ECG, PR, NIBP, SpO2, TEMP, RESPand EtCO2in clinic units.
The expected operator position is about one meter around the monitor in normal use.
2.2 Components
The monitor is composed of the main unit (including battery, display screen, recorder andplug-in modules)
and functional accessories (including ECG cable, NIBP cuff, SpO2sensor, TEMP probe, CO2 sensor, FHR
transducer, TOCO transducer, FM marker, and fetus-awakeningvibratory stimulator).
2.3 Contraindications
None.
2-1
Overview
2.4 Appearance Introduction
2.4.1 Front View
Figure 2-1 Front view
Display screen
Backlight key. If you turn on the monitor and then close the screen, the backlight key will be
pressed down to turn off the backlight. When you open the screen, the backlight key will get
bumped to restore the display.
On: when the monitor is connected with AC power supply
AC indicator Off: when the monitor is disconnected with AC power
supply
Battery work On: when the monitor operates on battery power.
indicator Off: when the monitor does not operate on battery power.
Battery charge On: when the battery is being charged.
indicator Off: when the battery is fully charged.
Standby key
Alarm reset key Press to end the alarm signals for which no associated
alarm condition currently exits.
2-2
Overview
TOCO Zero key Press to perform TOCO zeroing.
Print key Press to start printing or stop printing

Paper tray
Control knob. Rotate clockwise or anticlockwise to move the cursor and highlight menu items;
press to perform a certain operation.
Keyboard
Alarm lamp
Multi-measurement module slot cover
2.4.2 LeftView
Ventilation Hole Other sockets

PlaceMulti-measurement
ModuleSlot Cover here
Figure 2-2 Left view
2-3
Overview
2.4.3 RightView
Multi-measurement
Module Slot Cover
Transducer Bracket Transducer Socket

Multi-measurement
ModuleRelease
Figure 2-3Rightview
Bracket for FHR transducer, TOCO transducer and FM marker (from left to right).
Socket for TOCO transducer, FM marker, FHR1 transducer and FHR2 transducer in any
order (the system can auto recognize the transducer).
Before inserting the C30/C31 multi-measurement module, please remove the

multi-measurement module slot cover and place it at the placement position for
multi-measurement module slot cover on the left side of the monitor.
Press to release the C30/C31 multi-measurement module.
How to install the C30/C31 multi-measurement module

(1) Remove the multi-measurement module slot cover from the monitor and place it at the placement
position for multi-measurement module slot cover on the left side of the monitor.
(2) Push the C30/C31 multi-measurement module into the multi-measurement module slot reliably with the
module interface facing the outside.
(3) To remove the C30/C31 multi-measurement module, press the release and pull it out.
Note
 The multi-measurement module refers to the C30/C31 product manufactured by Comen.
 The monitor is compatible with the modules manufactured by Comenonly.
2-4
Overview
2.4.4 RearView
Handle
USB Connector Power Socket

Network Connector Equipotential
grounding terminal
Figure2-4 Rear view
Warning
 The network connector is designed for Comen central monitoring system only.
 Only the analog or digital equipments complying with the specified IEC standards (like IEC
60950 for data processing equipments, IEC 60601-1 for medical equipments, etc.) are allowed
to be connected to the monitor. The configuration of these equipments should comply with the
valid version of IEC 60601-1-1 standards. The person who connects external equipments to the
signal I/O ports should configure the medical system and ensure the medical system
complies with IEC 60601-1-1 standards. If you have any question, please contact the supplier.
 If more than one external equipment are connected to the monitor at one time through the
patient cable socket, network connector or other signal interfaces, the total leakage current
should not exceed the allowance.
2-5
Overview
2.4.5 Bottom View
Fetal Heart Speaker

Nameplate
Paper Tray
Handle
Alarm Speaker
Battery Tray
Figure 2-1 Bottom View
2.4.6 Keyboard
The Monitor is equipped with a keyboard containing both character keys and functional keys. See the figure
below:
Figure 2-6 Keyboard
No. Symbol Name Description

Exit key Exit the current dialog box.
Press to end the alarm signals for which no associated alarm
Alarm reset key
condition currently exits.
Press it to pause the alarm for the set alarm pause time and
Alarm pause key
press it again to resume the alarm.
Alarm VOL+ key Press it to increase the alarm volume to a higher level.
Alarm VOL- key Press it to reduce the alarm volume to a lower level.
2-6
Overview
Fetal heart VOL+ Press it to increase the fetal heart volume to a higher level.
key
Fetal heart VOL- Press it to reduce the fetal heart volume to a lower level.
key
Key tone VOL+ Press it to increase the key tone volume to a higher level.
key
Key tone VOL- Press it to reduce the key tone volume to a lower level.
key
Start/Stop If the required transducers are connected, you can press this
monitoring key key to start or stop monitoring the patient.
Save case / cancel
Save or cancel saving the case.
saving key
Press it to enter the pop-up window [Patient Info & Advance
Print key
Fischer Grade (FHR1)].
Press it to freeze the waveform in the waveform section so as
Freeze key to observe the 60h FHR waveform and 240s mother
parameter waveform.
NIBP measure key Press it to measure the NIBP.
TOCO Zero key Press it to zero the TOCO.
Delete key Delete the last character you’ve input.
Lock/Unlock key Lock/unlock the screen.

Hide/show the bottom menu bar, same as swiping the screen
Hide/Show key
up and down.
Switch to the previous interface, same as swiping the screen
Previous key
from left to right (right swipe).
Main menu key Press it to enter [MAIN MENU].
Input method Press it to switch among such input methods as Englishand

switching key handwriting.
Work interface key Press it to enter [SCREENS].
Switch to the next interface, same as swiping the screen from
Next key
right to left (left swipe).
Clear key Clear all the characters you’ve input.
2.5 On-screen Display
The LEDcolor touch screen can display the patient parameters, waveform, alarm message, system time,
network connection status, bed number, battery status and other messages simultaneously.
2-7
Overview
Figure2-7 Main screen
1. Network Connection Status Icon

 Show the network connection status between monitor and central monitoring system.
 indicating that the network between the monitor and central monitoring system has not been
connected successfully;
 indicating that the network between the monitor and central monitoring system has been
connected successfully;
 Click the network connection status icon to directly access [NETWORK SET] menu.
2. Patient Information
 If no patient is admitted, the promt message “No Patient Admitted” will be displayed here. If a
patient has been admitted, the patient name, bed number, etc. will be displayed here circularly.
 Click here to directly access [PATIENT INFO] menu.
3. Technical alarm message are
Display technical alarm message and status message. When there are multiple messages, they will be
displayed circularly.
4. Physiological alarm message are
 Display physiological alarm message. When there are multiple messages, they will be displayed
circularly.
 Click here to directly access [ALARM RECALL] window.
5. Timed monitoring information
 Display the timed monitoring information here;
2-8
Overview
 Click here to directly access [TIMER] menu.

6. Icons
 Printer icon: display the printing status. During printing, this icon will show moving paper. Click it
to directly access [PRINT SETUP] menu.
 FHR volume icon: click to adjust the FHR volume directly.
 Alarm volume icon: click to adjust the alarm volume directly.
 Battery status icon: display the battery charge level. Click to directly access [POWER MANAGE]
menu.
7. System time
 Display the system time
 Click here to directly access [DATETIME SETUP] menu.
8. Waveform area
 Display the measurement waveforms with the waveform name at the left top corner.
 Click the waveform area and the corresponding setup menu will be displayed.
9. Parameter area
 Display the measured value and the alarm limit of each measurement parameter.
 The color of a certain parameter is the same as that of its waveform.
 Click each parameter area and the corresponding setup menu will be displayed.
10. On-screen keys
 Click each on-screen key and the corresponding setup menu will be displayed or a certain
operation will be performed.
 Click or to show more on-screen keys.
2-9
Chapter 3 Installation
3.1 Unpack and Check
Carefully unpack 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
our sales department or agency immediately.
3.2 Connect the AC Power Cord
Before connecting the power cord, confirm that the AC power supply meets the following specifications:
100-240V , 50Hz/60Hz.
Use the power cord provided along with the monitor, and connect the power plug to the grounded
three-wiresocket.
Note
 To ensure the monitor’s safe operation, please only use the accessories (like FHR transducer)
and consumable materials provided or specified by Comen.
 Please connect Comen equipment to the monitor only. If you connect any other electrical
equipment or device to the monitor, there could be safety problems caused by superimposed
leakage current.
 Plug the power cord to the dedicated hospital socket.
 Please charge the battery after the transport or storage of the monitor. Otherwise, if you turn
on the monitor without connecting it to the AC power supply, the battery power may not
support its normal operation. The battery will be charged when the AC power supply is
connectedwhether you turn on the monitor or not.
3.3 Turn on the Monitor
Press the standby key on the front panel and the system begains self-test. The alarm lamp turns red,yellow
and blue in turn. The system will enter the main screen and gives a beep at the same time after showing the
company logo and loading configuration files.
Note
 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.
3-1
Installation
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
Comen.
3.4 Connect the Sensors
Connect the required sensor to the monitor and attach it to the patient.For the correct connection methods
and related requests, please refer to relevant chapters.
3-2
Chapter 4 Patient safety
4.1 Safety Instruction
The design of the fetal& maternal monitor complies with the international safety standard regarding medical
electrical equipment. The monitorhasthe functions of defibrillation protection with floating input and surgical
electrotome protection.
4.2 Enviroment Requirements
The following guidance should be followed to ensurethe 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 5 40 (runing) to satisfise the
requirements, An ambient environment out of this range may impair the instruments accuracy and cause
damages to its components and circuits.
4.3 Grounding protection
To protect the patients and operator, the enclosure of the monitor must be grounded. The monitor is
equipped with a removable three-wire cable. When the cable plugs in a matching plug connector, the
grounding wire of the power line ground the monitor. In case a three-plug connector is not available, the
electrical operating staff should be consulted.
Warning
 Replacement of the three-plug connector with a two-plug connector is strictly prohibited.
The grounding wire should be connected with the equipotential grounding terminal of the instrument. The
instrument users who do not know whether a given combination of instruments may invite dangers, e.g. due
to accumulations of leaked currentsshould 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.
4-1
Patient Safety
4.4 Equipotential Grounding
The primary protection of the instrument is embodied in the building protective grounding (protective
ground) system by means of power plugs grounding. The multi-parameter monitor should be separately
connected with the equipotential grounding system for examinations of hearts or skulls. One end of the
euquipotential grounding leads (potential equilizing leads)should be connected onto the equipotential
grounding terminals on the rear panel of the instrument and the other should be connected onto one
connector of the equipotential system. The equipotential grounding system should be in place for safety
functions of the protective grounding leads in case of any damage to the protective grounding system.
Cardiac or brain examinations should be conducted only in the rooms equipped with protective grounding
systems. A check of the instruments should be conducted to guarantee the instruments are in good repair
before each examination. The cables connecting with patients and instruments should be guaranteed not
having been subjected to electrolytic pollution.
Warning
 Battery power should be used to power the monitor against unstable protective grounding
system.
4.5 Condensation
The working instruments should be guaranteed not to form any condensation. Transferring of the instrument
from one room to another may cause condensation on the instrument. This is attributed to its exposure to
humid air at different temperatures.Unnecessary problems can be avoided by placing the instrument in a dry
place before putting it into use.
Note: Condensation is defined as coagulation of gases or liquids when cooled, e.g. water vapor when cooled
is transformed into water and water when cooled into ice. The lower the temperature is, the faster
condensation is formed.
Warning
 The monitor is prohibited to use in the presence of combustible anesthetics so as to avoid any
risk of explosions.
 Do not operate the monitor in the MRI scanning process, or you could be burnt by the induced
current.
4-2
Chapter 5 Basic Operations
5.1 Using the Main Menu
How to access [Main Menu]:
Click the on-screen key or press on the keyboard to access [MAIN MENU] and perform
operations and settings.
Figure 5-1 Main menu
Attention
 All settings you’ve made will be saved and memorized by the system without being changed
due to power failure or power interruption, unless you restore the factory default settings
manually.In case of power interruption, the mointor will save all the settings and saved patient
data; when restarting the monitor, the monitor will restore to the settings before power
interruption.
5.2 General Settings
5.2.1 Setting the System time
There are two methods of setting the system time:

1. Click the system time to enter the [DATETIME SETUP] menu;
2. Or access [MAIN MENU] [MAINTAIN] [MONITOR SETUP] [TIME SETUP];
5-1
Basic Operations
3. Set the system time according to your local time.
5.2.2 Changing System Language
1. Access [MAIN MENU] [MAINTAIN] and enter the password;

2. Click [LANGUAGE] to select the required system language.
5.2.3 Adjusting Alarm Volume
For specific methods of adjusting alarm volume, please refer to8.4 Adjusting Alarm Volume.
5.2.4 AdjustingHeartbeat Volume
1. Access [MAIN MENU] [SELECTION] [BEAT VOL];

2. Select the heartbeat volume in the pop-up list box;
3. Available volume levels are 0 to 6. 0 means the heartbeat volume is turned off and 6 is the maximum
volume.
5.2.5 AdjustingFHR Volume
There are three methods of adjusting the FHR volume:

1. Access [MAIN MENU] [SELECTION] [FHR VOL];
2. Or click FHR volume icon ;

3. Select the FHR volume in the pop-up list box;
4. Available volume levels are 0 to 6. 0 means the FHR volume is turned off and 6 is the maximum
volume.
5. Or press or on the keyboard to increase or decrease the FHR volume respectively.
When the FHR volume is 0, the FHR volume icon turns to , indicating the FHR volume is 0.
Warning
 Please do not use the maximum fetal heart volume more than 12 hours per day, or the high
level volume pressure will cause harm to patient.
5.2.6 Adjusting Key Volume
1. Access [MAIN MENU] [SELECTION] [KEY VOL];

2. Select the key volume in the pop-up list box;
3. Available volume levels are 0 to 6. 0 means the key volume is turned off and 6 is the maximum volume.
5-2
Basic Operations
5.2.7 Adjusting Screen Brightness
1. Access [MAIN MENU] [SELECTION] [LCD LIGHT];

2. Select the screen brightness level in the pop-up list box;
3. Available brightness levels are 1 to 6. 1 is the least brightness and 6 is the brightest.
5.3 Module Setup
1. Access [MAIN MENU] [MONITOR SETUP] [MODULE SETUP];

2. Click the a certain parameter module to enable or disable its measurement function;
The fetal module defaults to on under fetal monitoring screen and mother/fetus monitoring screen and cannot
be disabled. While the fetal module defaults to off under mothermothering screen, trend screen and oxyCRG
screen and cannot be enabled.
5.4 Monitor Information
Monitor information is mainly for viewing the software version information operated by the monitor, so as to
facilitate the manufacturer to maintain and trace the monitor.
Access [MAIN MENU] and click [INFO] to view the software version V1.
5.5 Demo Function
To enable Demo function:

1. Access [MAIN MENU];
2. Click [DEMO] and enter the password
Warning
 Demo waveform is a kind of simulation of waveformswhich is made by the manufacturer only
to demonstrate the machine performanceand 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 patientwhich affects monitoring and delays
diagnosis and treatment.
5.6 Locking the Touch Screen
To lock the touch screen:
Press on-screen key and hold for more than three seconds until the turns to , which
indicates the touch screen is locked.
5-3
Basic Operations
To unlock the touch screen:
Press and hold for more than three seconds until it turns to , which indicates the touch
screen is unlocked.
5.7 Network Settings
This monitor can be connected to the central monitoring system via wired network. The specific methods are
as follows:
1. Click the network connection status icon to enter [NETWORK SET] menu;
2. Click [NET BED] to enter the network bed number of this monitor on central monitoring system. Valid
range is 1 to 64;
3. Click [IP ADDRESS] to enter the IP address of this monitor, for example, 200.200.200.X. The valid
range of X is 1 254. If the entered value is out of this range, the valid range will be displayed.
4. Click [MAC] to enter the MAC address of this monitor;
5. Click [SUBNET MASK] to enter the subnet mask of this monitor;
6. Click [SERVER IP] to enter the IP address of the central monitoring system. The server IP and IP
address of the monitor must be in the same network segment.
How to recognize whether the network has been connected successfully:
Icon indicates the network between this monitor and central monitoring system has not been connected
successfully;
Icon indicates the network between this monitor and central monitoring system has been connected
successfully.
Attention
 The network bed number must be unique and cannot be the same as that of any other monitor
connected to the central monitoring system, or it will cause signal deadlock because of the
preemption of the central monitoring system channel.
 If the monitorsystem 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.
5.8 Frozing Waveform
How to freeze waveforms on the screen:
1. Press the key on the front panel or click [FROZEN] on-screen key;
2. The on-screen key area turns to the figure as below:
5-4
Basic Operations
3. All displayed waveforms are frozen without being refreshed or scrolling. But the measured parameter
values are refreshed normally.
How to review frozen waveforms:

The users can freeze the waveforms on the screen during patient monitoring and view the waveforms in
detail. Totally 240s frozen maternal parameter waveforms and 60h frozen fetal waveform can be reviewed on
this monitor.
1. Under frozen waveform status, click [PRE PAGE] or [NEXT PAGE] to view the frozen waveforms on
previous page or next page respectively;
2. Click [FIRST PAGE] or [LAST PAGE] to view the frozen waveforms on the first page or on the last
page respectively;
3. Click [BACK] or press the key to unfreeze the displayed waveforms.
How to record the frozen waveforms:

Please refer to Printing for the specific steps of recording the frozen waveforms.
5-5
Chapter 6 Patient Management
6.1 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 admitthe patient.
To admit a patient:
1. Click patient information displayor click [PAT MANAGE] on-screen key and the [PATIENT MANAGE]
menu will displayed.
2. If a patient has been admitted, please click [DISCHARGE] to discharge the patient;
3. If no patient is admitted, please enter the patient information in detail, especially for the pacemaker
status. If you set the item [PACE] to [ON], when pacemaker signal is detected, the symbol will
appear above the ECG waveform and the icon will appear in the ECG parameter area. If the item
[PACE] is set to [Off], you will see the icon in the ECG parameter area.
4. Click [ADMIT] and a dislogbox “Will erase previous patient’s hist data! ADMIT?” will be
displayed.Select [Yes] to admit the patient, and the [ADMIT] item turns to [DISCHARGE]; select [No],
the patient will not be admitted.
Warning
 When change the patient type or admit a new patient, the monitor will restore to the alarm
settings of that patient type set previously. Therefore, the users should check whether the
alarm settings are suitable for the patient prior to monitoring.
 For patients without pacemaker, you should set [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, pacemaker pulse
may be counted into normal QRS waves, causing the alarm “ECG signal is too weak” cannot
be detected.
Attention
 If the patient information is wrong, it will be impossible to print the correct basic
patientinformation and auto score result. Discharge the patient before admitting a new
patient, or the monitor will auto take the previous patient as the current patient.
 After discharging the patient, the [PACE] defaults to [OFF].
6-1
Patient Management
6.2 Discharging Patient
How to discharge a patient:

1. Click patient information displayor click [PAT MANAGE] on-screen key and the [PATIENT MANAGE]
menu will displayed.
2. Click [Discharge] and the patient will be discharged.
3. Then the patient information shows prompt message “No Patient Admitted”.
6.3 Patient Case Management
6.3.1 Save Patient Case
The patient cases can be saved manully or automatically. Saving patient case manually means the patient
cases are saved manully by users during real-time monitoring; while saving patient case automatically means
a new patient case will generate automatically during real-time printing.
How to save patient case manually:
1. Access [MAIN MENU] [Case List]
2. Click [Case save] and select [ON]. If [Case save] is set to [OFF], no patient cases will be saved.
3. During monitoring, click [SAVE CASE] on-screen key and start to save the patient case. Any patient
case which has been saved for more than 10 seconds will be stored after pressing the [Stop Save]
on-screen key;
4. All the saved patient cases can be viewed in the [Case list] window.
How to save patient case automatically:
1. Access [MAIN MENU] [Case List]
2. Click [Case save] and select [ON]. If [Case save] is set to [OFF], no patient cases will be saved.
3. Click [Least time] and select the least monitoring time so that a new patient case will be saved.
Available options include 5 minutes, 10 minutes, 15 minutes and 20 minutes. For example, 5 minutes
means if the fetal monitoring time is less than 5 minutes, a new patient case will not be saved in [Case
List] window; and so on.
4. All the saved patient cases can be viewed in [Case List] window.
6.3.2 View Patient Case
All the saved patient cases can be viewed, deleted and loaded in the [Case list] window. The specific steps
are as follows:
1. Access [MAIN MENU] [Case List] [Case list];
2. The [Case list (SD)] window displays all the saved patient cases. [Case list (SD)] means the displayed
6-2
Patient Management
patient cases are saved in the SD card.
3. Click or and view the patient cases not in current page;
4. Click [Delete All] and all the patient cases in the case list window will be deleted;
5. Select a certain patient case and view it in the [Patient Review] window.
6. Click [Delete] and this patient case will be deleted; click [Load] and enter the patient case review
interface where the users can view this patient case in detail and print it.
6.3.3 Import or Export Patient Case via USB Flash Disk
The monitor allows you to import or export patient cases via USB flash disk. Specific methods are as
follows:
1. Connect the USB flash disk to your computer and format it. Select FAT or FAT32 as the file system
format. Remove the USB disk when formatting is finished.
2. Connect the USB flash disk to your monitor;
3. Access [MAIN MENU] [Case List] [Case list];
4. If the items [Remove USB] and[USB Copy]appear in the case list window, the monitor has recognized
the USB flash disk; or please reconnect the USB flash disk.
5. To export patient cases, select[USB Copy]and a dialogue box will appear, and then select[Copy to USB]
to export all patient cases to USB flash disk; oryou can also select a certain patient, and then select
[Copy to USB] and this patient case will be exported to the USB flash disk;
6. To import patient cases from the USB flash disk to the case list window, select [USB Copy] and a
dialogue box will appear, select [Enter USB Case List], then select[USB Copy], and then select [Copy
to SYS]. You can also select a certain case in the [Case list (USB)]window and then select [Copy to
SYS] to import this patient case to the system.
7. The patient cases in the USB flash disk can also be loaded or deleted in the case list window. The
specific methods are the same as that of the patient cases in the system. When entering the USB case
list window, the window name will be [Case List (USB)].
8. Click [Remove USB] and disconnect the USB flash disk from the monitor;
9. Connect the USB flash disk to the computer and store the patient cases.
6-3
Chapter 7 User Screens
7.1 Overview
The monitor provides several operation screens for the user to select, including fetal monitoring screen,
mother/fetus monitoring screen, mother monitoring screen, list screen, trend screen, oxyCRG screen and big
font screen. User can get different screen messages from different screens.
There are three methods of swtiching operation screens:
1. Press on the keyboard or click [SCREENS] on-screen key, the [SCREENS] menu will be
displayed and then select the required operation screen.
2. Press or on the keyboard to select the previous screen or next screen respectively.
3. Swiping the screen to the left or right to switch the operation screens.
7.1.1 Fetal Monitoring Screen
You can see the FHR value, FHR trace, TOCO value, TOCO waveform, manual/auto FM mark and auto
FM waveform on the fetal monitoring screen.
To open the fetal monitoring screen:
(a) Access [SCREENS] menu;
(b) Select [FETAL SCREEN] to open the fetal monitoring screen, as shown below:
Figure 7-1Fetalmonitoring screen
7-1
User Screens
7.1.2 Mother/Fetus Monitoring Screen
The mother/fetus monitoring screen can display fetal parameter value and waveform as well as mother
parameter value and waveform simultaneously. It is especially suitable for use in the delivery room.
To open the mother/fetus monitoring screen:
(b) Select [MOTHER/FETUS CARE FACE] to open the mother/fetus monitoring screen, as shown below:
Figure7-2 Mother/fetus monitoring screen
7.1.3 Mother Monitoring Screen
The mother monitoring screen can only display mother parameter value and waveform.Up to 4 channels
of waveform can be displayed with a separate parameter area.
To open the mother monitoring screen:
(b) Select [MOTHER CARE FACE] to open the list screen, as shown below:
7-2
User Screens
Figure7-3 Mother monitoring screen
7.1.4 List Screen
List screen can display the list of the measured parameter values. The list occupieshalfof the entire waveform
area. On the list screen, you can review the recently measured data, which is stored 10groups per page.
To open the list screen:
(b) Select [LIST FACE] to open the mother monitoring screen, as shown below:
Figure7-4 List screen
Under the list screen, you can activate the FETAL module to display the fetus parameter value and waveform.
7-3
User Screens
To activate the FETAL module, access[MAIN MENU] [MONITOR SETUP] [MODULE SETUP] and
set [FETAL] to [ON].
7.1.5 Trend Screen
What displayed on the trendscreen is the dynamic short tendency chart. From the dynamic short tendency
chart, you can see the recent tendency of each parameter. The label of the tendency is displayed above each
tendency chart, with the scale on the leftand the time below, as shown in the figure below:
Figure 7-5 HR dynamic short tendency
The position of the dynamic short tendency chart of each parameter is not fixed. You can change the position
of the tendency chart as needed. Take the SpO2 dynamic short tendency for example, with the steps as
follows:
Select the SPO2 dynamic short tendency and select HR in the pop-up list, and then the HR dynamic short
tendency appears at the original position of SpO2 dynamic short tendency.
To open the trend screen:
(b) Select [TRENDSCREEN] to open the trend screen, as shown below:
Figure7-6 Trendscreen
7-4
User Screens
 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.
7.1.6 OxyCRGScreen
OxyCRG screen displays the oxyCRG chart which is comprised of HR tendency, SPO2 tendency and RR
tendency or compressed respiratory wave and occupies one half of the entire waveform area.
To open the OXYCRGscreen:
(b) Select [OXYCRGSCREEN] to open the oxyCRG screen, as shown below:
Figure7-7 OxyCRGscreen
 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 compressed respiratory wave or RR tendency
Select the oxyCRG chartand one menu[OXYCRG] will be displayed. Select [TYPE] and select [RESP
WAVE] or [RR] to display compressed respiratory wave or RR trendency respectively.
7-5
User Screens
7.1.7 Big FontScreen
Big font screen can display four parameters with super-large font, which facilitates the doctor to observe the
monitored value within a certain distance.
The users can select to display the mother parameters. Take FHR1 as an example: select the FHR1 parameter
area and the menu [FHR1 SETUP] will be displayed; select [SUBMIT MODULE] and then select [RESP];
then the RESP parameter will appear at the position of FHR1 parameter.
To open the Big font screen :
(b) Select [BIG FONT] to open the big font screen, as shown below:
Figure 7-8 Big font screen
7.2 Swipe the Screen
The monitor allows you to swipe the screen up and down or left and right to switch the screens.
1. Swipe Up and Down
Byswiping the screen from up to down, the waveform area and parameter area will expand and hide the
screen keys so that the doctor can observe the measured data more clearly. Swipe the screen from down to up
to show the screen keys.
2. Swipe Left and Right
Byswiping the screen from right to left, the screens will be switched in such sequence as[FETAL SCREEN]
[MOTHER/FETUS CARE FACE] [MOTHER CARE FACE] [LIST FACE] [TREND
SCREEN] [OXYCRG SCREEN] [BIG FONT] [FETAL SCREEN]. If you swipe the screen
from left to right, the screens will be switched in the reverse sequence.
7-6
User Screens
7.3 Tailoring Your Screens
You can tailor your monitor’s screen by setting:

 Waveform sweep speed;
 Waveform display style;
 Parameter and waveform display color;
 Waveform exchange;
7.3.1 Changing the Waveform Sweep Speed
1. Select the waveform of fetal parameters, for example FHR waveform, and the menu [FHR SETUP] will
be displayed. Select [SWEEP] and choose the sweep speed for FHR waveform from [1 CM/MIN], [2
CM/MIN] and [3 CM/MIN].
2. Select the waveform of maternal parameters, for example ECG waveform, and the menu [ECG
WAVE] will be displayed. Select [SWEEP] and choose the sweep speed for ECG waveform from
[6.25mm/s], [12.5mm/s], [25.0mm/s] and [50.0mm/s].
7.3.2 Setting the DisplayColor
1. Select the waveform of fetal parameters, for example FHR1 waveform, and the menu [FHR
SETUP] will be displayed. Select [FHR1 DISP COLOR] and choose the display color for
FHR1 waveform from [GREEN], [CYAN], [RED],[YELLOW], [WHITE], [BLUE] and [PURPLE];
WAVE] will be displayed. Select [WAVE COLOR] and choose the display color for ECG waveform
from [GREEN], [CYAN], [RED],[YELLOW], [WHITE], [BLUE] and [PURPLE].
7.3.3 Setting the Waveform Display Style
This operation is not available for fetal monitoring waveforms.

WAVE] will be displayed.
2. Select [WAVE TYPE] and choose the waveform display style from [LINE], [COLOR]and[BOLD]
7.3.4 Waveform Exchange
This operation is not available for fetal monitoring waveforms.

WAVE] will be displayed.
2. Select [WAVE EXCHANGE] and select the waveform to be exchanged.
7-7
Chapter 8 Alarm
8.1 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
violates the alarm limit or by the physiological abnormality of the patient. The physiological alarm
message 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.
8.2 Alarm Level
The monitor can give an alarm in three levels:high, medium and low, based on the severity.
Physiological alarm Technical alarm
Indicate a severe device malfunction or an
The patient is in a critical
improper operation, which could make it possible
condition, endangering the
High level that the monitor cannot detect critical patient
patient’s life, emergent attention
status and thus threaten the patient’s life, such as
required.
low battery and so forth.
The patient’s vital signs are Indicate a device malfunction or an improper
Medium abnormal, relevant measures and operation, which may not threaten the patient’s
level treatment are immediately life but may compromise the monitoring of vital
required. physiological parameters.
The patient’s vital signs are Indicate a device malfunction or an improper
abnormal and relevant measures operation, which may compromise a certain
Low level
monitoring function but will not threaten the
and treatment may be required. patient’s life.
All alarm levels for technical alarms and some physiological alarms have be set before the monitors are
delivered, and the users are not allowed to change them. But the level of some physiological alarms can be
modified.
8-1
Alarm
8.3 Alarm Mode
When giving an alarm, the monitor will prompt the users in both audio and visual modes:
 Visual alarm
 Audio Alarm
 Alarm Message
 Parameter’s flashing
In which visual signal, audio signal and alarm message are differentiated with those in different alarm levels.
8.3.1 Visual Alarm
The alarm lamp will flash at different frequencies and in different colors for different levels of alarms.
Physiological alarm:
 High level alarm: flash twice per second in red.
 Medium level alarm: flash once every two seconds in yellow.
 Low level alarm: yellow, continuous light.

Technical alarm:
 High level alarm: flash twice per second in red.
 Medium level alarm: flash once every two seconds in yellow.
 Low level alarm: cyan, continuous light.
When physiological alarm and technical are triggered simultaneously, the flashing frequency and color of
alarm lamp are based on the highest alarm level priority. But when only physiological alarm and technical
alarm of low level are triggered, the flashing frequency and color of alarm lamp are that of physiological
alarm.
8.3.2 Audio Alarm
The audio alarm is to prompt the alarm in different levels of severity with different sounds.
 High level alarm: Do-Do-Do--Do-Do----Do-Do-Do--Do-Do.
 Medium level alarm: Do-Do-Do.
 Low level alarm: Do.
Warning
 Both bedside machines and central monitoring systems have audio alarm function.
 Once the bedside monitor is connected to a central monitoring system,although both the
bedside monitor and central monitoring system can coordinate the alarm level as well as the
the alarm limit, the bedside monitor may not give an alarm simultaneously when the central
monitoring system is giving an alarm due to the alarm delay function of the bedside monitor.
8-2
Alarm
 When alarms of multiple alarm level are triggered simultaneously, the monitor will give the
alarm in audio and visual mode based on the highest alarm level priority.
8.3.3 Alarm Message
When there is a technical or physiological alarm, you will find a technical or physiological alarm message in
the technical alarm message area or physiological alarm message area respectively. Alarm messages for
different alarm levels are displayed in different background colors:
 High level alarm: red (Physiological alarm), blue(Technical alarm)
 Medium level alarm: yellow
 Low level alarm: yellow
Messages for different levels starting with different marks:
 High level alarm: ***
 Medium level alarm:**
 Low level alarm: *
8.3.4 Alarm Parameter Flashing
When a parameter triggers an alarm, the parameter will flash once every second.The upper alarm limit or
lower alarm limit will also flash in the same frequency indicating the parameter has violated the upper limit
or lower limit repectively.
8.4 Adjusting Alarm Volume
8.4.1 Adjusting the Minimum Alarm Volume
The minimum alarm volume is set to avoid the situation that the alarm can not be heard due to the alarm
volume being set too low. It decides the minimum alarm volume which can be set by users.
How to adjust the minimum alarm volume:
1 Access [MAIN MENU], press [MAINTAIN] and enter the password.
2 Select [ALARM SETUP];
3 Select [MIN ALARM VOL] to select the minimum alarm volume from 0 to 5.
8.4.2 Adusting the Alarm Volume
There are three ways to adjust the alarm volume:
1 Access [MAIN MENU], select [SELECTION], select [ALARM VOL] and then select the alarm
volume in the pop-up list box from X to 6. X is the minimum alarm volume;
8-3
Alarm
2 Or press alarm volue icon to selectthe alarm volume in the pop-up list box from X to 6. X is
the minimum alarm volume.
3 Or press or to increase or decrease the alarm volume respectively.
When the alarm volume is set to 0, the icon will appear on the screen 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.
8.4.3 Setting the Reminder Tone
When alarms are switched off, the monitor will give periodic reminder signal: Ting---Ting---Ting--- to
remind the users that the alarm system is switched off.
How to set reminder tone:
1 Access [MAIN MENU], select [MAINTAIN] and enter the password.
2 Select [ALARM SETUP];
3 Select [REMINDER TONE] toadjust the reminder volume from 0 to 6. 0 means off and there is no
reminder tone when alarms are switched off. 6 means the maximum reminder tone.
4 Select [REMINDER INTERVAL] to adjust the reminder interval. Available options include OFF, 6s,
15s, 30s, 60s, 300s and 600s.
8.5 Alarm Settings
8.5.1 Setting the Alarm Level
How to set the alarm level, here we take RESP as an example:

1. SelectRESP parameter area;
2. Select [ALM LEV];
3. Select the alarm level in the pop-up list box.
8-4
Alarm
8.5.2 Setting the Alarm Limit
The smart alarm system is the feature of our monitor. For smart alarm parameter, the users can set the upper
and lower limit of the high level alarm, medium level alarm and low level alarm together with no need to set
the alarm level. When the measured value of a certain parameter violates the alarm limits, the monitor will
auto give a corresponding alarm according to the alarm limits of which alarm level having been violated.
For normal alarm parameter, the users need to set the alarm level and only the alarm limits of the selected
alarm level can be set. When the measured value violates the alarm limits, the monitor will only give alarms
of the selected alarm level. Except for TEMP and RESP parameter, the alarm of FHR, TOCO, ECG, NIBP,
PR, CO2 and SpO2 parameter is smart alarm.
The methods to set the alarm limits for all smart alarm parameters are similar, and here we take FHR1 as an
example:
1 Select FHR1 parameter area and the [FHR1 SETUP] menu will be displayed;
2 Select [FHR1 ALARM SETUP] and enter FHR1 alarm limit setup menu, as shown below:
Here we can set the alarm limits of high level alarm, medium level alarm and low level alarm together.
 [Hi-Level] means high level alarm. When the measured value is higher than the upper limit of high
level alarm or lower than the lower limit of high level alarm, the monitor will give a high level alarm.
 [Mi-level] means medium level alarm. When the measured value isbetween the the upper limit of high
level alarm and medium level alarm, or between the lower limit of medium level alarm and high level
alarm, the monitor will give a medium level alarm.
 [Lo-level] means low level alarm. When the measured value is between the the upper limit of medium
level alarm and low level alarm, or between the lower limit of medium level alarm and low level alarm,
the monitor will give a low level alarm.
3 Select the upper limit and lower limit of a certain alarm level and click or to adjust the alarm
limits. The red area means high level alarm, yellow area means medium level alarm, cyan area means
low level alarm and white area means the normal range.
The methods to set the alarm limits for all normalalarm parameters are similar, and here we take RESP as an
8-5
Alarm
example:
1. Select RESP parameter area and the [RESP SETUP] menu will be displayed;
2. Select [ALM LEV] and select [HIGH] or [MED];
3. Select [RESP ALARM SETUP] and enter the RESP alarm limit setup menu, as shown below:
Here only the alarm limit of the selected alarm level can be set.
4. Select the upper limit and lower limit and click or to adjust the alarm limit.
Warning
 Setting alarm limit 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.
8.5.3 Alarm Recording
The monitor can record alarms automatically when the alarms are triggered if the parameter alarm function
and alarm recording function are activated. The methods of activating the alarm recording function for all
parameters are similar. Here we take ECG as an example:
1. Access [MAIN MENU] [MONITOR SETUP] [ALARM SETUP] [Review Alarms](Alarm
Recording) and select [ON];
2. Press ECG parameter area;
3. Press [ALM REC] and select [ON];
4. When the measured ECG value violates the alarm limit, the monitor will auto record the
ECG waveform with the recording time of 4 seconds before and after the alarm moment.
8-6
Alarm
8.5.4 Setting the Alarm Delay Time
The alarm system provides five kinds of alarm delay time: [DISABLED], [5SEC], [10SEC], [15SEC] and
[20SEC]. [DISABLED] indicates that the monitor will give alarms immediately once the measured
parameter value violated the alarm limit; [5SEC] indicates the monitor will give alarms only when the
measured parameter value exceeds the alarm limit for continual 5 seconds; and so forth. The alarm delay
function is not available on ECG parameter.
How to set the alarm delay time:
1. Access [MAIN MENU], select [MAINTAIN] and enter the password;
2. Select [ALARM SETUP];
3. Select [ALM DELAY TIME] and select the alarm delay time.
8.6 Pausing Alarms
You can press the key on the keyboard or click [ALM PAUSE] on-screen key to pause the alarm
triggered and put the alarm system into alarm paused status.
During alarm paused status:
 All the indications of physiological alarms are stopped and no new physiological alarm will be
triggered.
 The remaining alarm pause time appearsin the physiological alarm message area.
 [ALM PAUSE] on-screen key flashes in red.
 For technical alarm, the audio and visual alarm indicationsare paused but alarm message still appears in
technical alarm message area. If new technical alarm is triggered during alarm paused status, only the
alarm message of this technical alarm will be displayed without audio and visual alarm indication.
When the remaining alarm pause time ends, the alarm paused status will be automatically cancelled. You can
also cancel the alarm paused status by pressing the key on the keyboard or clicking [ALM PAUSE]
on-screen key.
8.6.1 Setting the Maximum Alarm Pause Time

2. Select [ALM SETUP]
3. Select [MAX ALM PAUSE TIME] andselect the maximum alarm pause time. Available options are 2
minutes through 10 minutes.
8-7
Alarm
8.6.2 Setting the Alarm Pause Time
1. Access [MAIN MENU]

2. Select [MONITOR SETUP]
3. Select [ALARM SETUP]
4. Select [ALM PAUSE TIME] to choose the alarm pause time from 1minute to X. X is the maximum
alarm pause time.
8.7 Switching off Alarms
8.7.1 Switching off Individual Parameter Alarm
How to switch off individual parameter alarm, here we take ECG as an example:
1. Select ECG parameter area;
2. Select [ALM] to toggle between [ON] and [OFF].
When the alarm function of an individual parameter is deactivated, the icon will appear in
corresponding parameter area.
8.7.2 Switching off All Parameter Alarms
Switching off all parameter alarms is password protected and can only be operated by the authorized
personnel. How to switch off all parameter alarms:
3. Select [ALM]and toggle between [ON] and [OFF].
Moreover, the operator can be authorized to switch off all parameter alarms following the steps below:
3. Select [ALM OFF Authorize];
4. Select [ON], and the operator can access [MAIN MENU] →[MONITOR SETUP] →[ALARM SETUP]
→[ALARM OFF] and select [ON] to switching off all parameter alarms.
When all parameter alarms are switched off, the system will give reminder tone periodically as the interval
set in [REMINDER INTERVAL]. During alarms off status:
 For physiological alarms, no alarm lamp flashes, no alarms are sounded and no measured parameter
value and alarm limit flash. Physiological alarm message are not be displayed.
 Prompt message “***ALARM OFF”is displayed in the physiological alarm message area with red
background.
8-8
Alarm
 For technical alarms, no alarms are sounded but with visual alarm and alarm message unchanged.
How to cancel all alarms off status:
1. Access [MAIN MENU] →[MONITOR SETUP] →[ALARM SETUP];
2. Select [ALARM OFF] and select [OFF].
Warning
 When alarms are switched off or paused, the monitor will not give alarm signals. Therefore, the
patient should be kept under close surveillance.
8.8 Latching Alarms
For this monitor, only four alarms can be latched: asystole, Ventricular fibrillation/Ventricular tachycardia,
RESP Apnea and CO2 Apnea.
The alarm latching setting defines how the alarm indicators behave when you do notacknowledge them.
When the latching alarm function is deactivated, the alarm indications of those four alarms will end when the
alarm condition ends. When the latching alarm function is activated, all visual and audible alarm indications
of those four alarms last until you reset the alarms, except thatthe measured parameter value and violated
alarm limit stop flashing as soon as the initial alarm condition goes away.
How to activate or deactivate latching alarm function:
1. Access [MAIN MENU], select [MAINTAIN] and enter the password
2. Select [ALARM SETUP]
3. Select [LATCH ALARM] and toggle between [ON] and [OFF].
8.9 Alarm Reset
By pressing the [ALARM RESET] screen key, the following operations can be conducted:
1. Clearthe latching alarm signals for which no associated alarm condition currently exists.
2. Cease the audio alarm signals of all physiological alarms and technical alarms.
3. Clearthe alarm signals for which no associated alarm condition currently exist, thus re-enabling the
alarm system to respond to future alarm conditions.
4. For lead off and sensor off technical alarm condition,clear the alarm lamp flashing and audio alarm
indication and the alarm messages turn to prompt messages displayed in the technical alarm message
area.
8.10 Alarm Presets
This monitor has two alarm presets: the factory adult/pediatric/neonate default settings and user
adult/pediatric/neonate default settings. Refer to Appendix IV for the factory alarm default settings.
8-9
Alarm
The factory adult/pediatric/neonate default settings can not be changed by users, but the users can modifiy
the default settings and save as user adult/pediatric/neonate default settings.
How to save user adult/pediatric/neonate default settings:
1. Change the alarm settings, for example, change alarm limit or alarm level;
3. Select [SAVE CURRENT AS USER CONFIG] to save current settings as user adult, pediatric or
neonate default settings based on current patient type.
How to use factory adult/pediatric/neonate default settings:
1. Access [MAIN MENU] [MONITOR SETUP] [RESTORE DEFAULT CONFIGURATION];
2. Select [ADOPT FACTORY DEFAULT ADU CONFIG], [ADOPT FACTORY DEFAULT PED
CONFIG] or [ADOPT FACTORY DEFAULT NEO CONFIG], the alarm settings will restore to the
factory default settings.
How to use user adult/pediatric/neonate default settings:
1. Access [MAIN MENU] [MONITOR SETUP] [RESTORE DEFAULT CONFIGURATION];
2. Select [USER DEFAULT ADU CONFIG], [USER DEFAULT PED CONFIG] or [USER DEFAULT
NEO CONFIG], the alarm settings will restore to the user default settings.
The users should notice the following items when using this monitor:
1. Once the alarm settings have been modified, the monitor will always save the modified alarm settings.
When changing the patient type, the monitor will restore to the alarm settings of that patient type set
previously. Therefore, the users should check whether the alarm settings are suitable for the patient
prior to monitoring.
2. The user can press the parameter area of a certain parameter to enter the setup menu, and then press
[DEFAULT] to restore the default settings of that parameter.
Warning
 A harzard can exist if different alarm presets are used for the same or similar equipment in any
single area, e.g. an intensive care unit or cardiac operating theatre.
8.11 Check the Alarm System
How to check the alarm system:

1. Connect the SpO2 cable with the monitor;
2. Select SpO2 parameter area and enter [SpO2 SETUP] menu;
3. Enable the SpO2 alarm function;
4. Enter SpO2 alarm limit setup menu and set the upper alarm limit to 97 and lower alarm limit 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 “SPO2
SENSOR OFF” in the technical alarm message area.
8-10
Chapter 9 Battery
9.1 Overview
The monitor is equipped with a built-in rechargeable batterywhich will be auto charged when the AC power
supply is connected no matterwhether 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 workindicator will be lit up after mains power failure.
To understand the battery icon:
: indicating the battery is fully charged.
: indicating moderate battery power.
: indicating low battery power.
: indicating critically low battery power, please charge the battery immediately.
: indicating no battery installed or damaged battery.
Attention
 Please remove the battery if it will be not be used for a long time and store it properly.
 If a battery is installed in the moitor, the battery must be charged 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 clean water or seek medical advise.
 Keep the battery out of the reach of children.
9.2 Low Battery Alarm
The monitor will automatically shut down in case of two low battery. When the battery icon turns to
, indicating the battery power is too low, the monitor will trigger a technical alarm with alarm
message of [Low Power level! Please charge the battery]. At this moment, the monitor should be
immediately connected to AC power supply to charge the battery, or the monitor will auto shut down before
the battery is fully used up.
9.3 Power Management
The power management function is designed to save power and reduce emission for the sake of
environmental protection.
9-1
Battery
Click battery icon to enter [POWER MANAGE] menu and set the following items:
 [TIMER]: click to select time interval from 1 minute to 30 minutes, within which if no operation
command is received, the monitor will trigger a command set in [TIMER CALL].
 [TIMER CALL]: set the command that the monitor will trigger if no operation command is
received within the time interval set in [TIMER], including [NONE], [HIDE BTTM BTTN](hide
bottonscreen keys), [LOCK SCREEN], [STANDBY] or [SHUTDOWN].
 [RECOVER FROM]: select [TOUCH SCREEN], [KEY] or [ANY OPERAT](any operation) as the
method of making the monitor return to the main screen after a command set in [TIMER CALL] is
triggered.
9.4 Battery Installation
Procedure of replacing or installing the battery:

(1) Turn off the monitor, and disconnect the power cord and other connection lines.
(2) Place the monitor with the bottom panel up.
(3) Unscrew the battery cover.
(4) Take out the used battery and put a new one into the battery holder.
(5) Screw the battery cover onand turn the monitor upright.
Warning
 Use only the supplier’s specified battery.

 Don’t dismantle the battery while the monitor is turned on.
 The installation and replacement of the battery should be performed by trained and qualified
personnel.
9.5 Optimization and Check of Battery Performance
(1) Optimization of battery performance

When the battery is used for the first time at least two complete cycles of optimization of the battery should
be carried out. A complete optimization cycle should be:uninterrupted charging battery until the power is full,
followed by use until the battery is fully discharged and monitor is automatically shut off.
This will ensure the battery is in optimization process:
(a) Disconnect the monitor from the patient and suspend all monitoring and measuring procedures.
(b) The optimized battery should be kept in the battery compartment of the unit.
(c) When charging the battery, at least six hours of charging should be ensured until it is fully charged.
(d) When you disconnect the AC power supply, the monitor is powered with the battery until the
battery runs out and the monitor automatically shuts off.
(e) This completes the battery optimization process.
9-2
Battery
(2) Check of Battery Performance

The service life of battery is changeable along with its storage, working environment charge cycles and
service time. Even though battery is out of service its performance will gradually deteriorate.
Procedure for checking the battery is as follows:
(a) Confirmwhether or not the battery is damage. When the battery shows the symbol “ ”, it
indicates the battery is damaged or no battery.

(b) Check whether the battery can be normally charged when the battery is connected to alternating
current;
(c) Disconnect the monitor from the patient and suspend 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 duration of battery discharge will reflect the battery performance.
(g) Once the discharge duration 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.
9.6 Battery Recycling
If the battery shows apparent damage or is at an energy exhaustion condition, it should be replaced
immediately, and the used battery should be recycled and properly disposed of in accordance with relevant
laws or rules and regulations for hospitals.
Warning
 Do not remove the battery or make it short-circuiting or put it into fire; otherwise, it would
cause battery on fire, explosion, harmful gas leakage or other dangers.
9-3
Chapter 10 Review
What can be reviewed on the monitor are the trend graph, trend table, NIBP measurement data, alarm event
andparameter waveform.
The monitor can save 120h trend data, 2,000 groups of NIBP data and 300 parameter alarm events and 120
minute parameter waveform for review.
10.1 Trend GraphReview
The trend graph in the latest 1 hour can be displayed with the resolution of one data every second or every 5
seconds; and the trend graph in the latest 120 hours can be displayed with the resolution of one data every
minute, or every 5 or 10 minutes.
How to enter trend graph review window:
1. Click [INFO RECA.] on-screen key;
2. Select [TREND GRAPH] to enter the trend graph review window, as shown below:
Figure 10-1 Trend graph review window
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. Display the trend graph of different parameters
Click the option box below [PARAM]and select the parameter in the pop-up list box, and the trend
graph of the selected parameter will be displayed.
2. Display 1h or 120h trend graph
10-1
Review
Click the option box below [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 lastest 120
hours.
3. Observethe earlier or latertrend curves
Select [TIME AXIS] and then press or to observe the earlier trend curves or thelater trend
curves respectively.
4. Change the Display Scale
Press or to change the scale of the vertical axisand the scale of the trend curve will change
accordingly.
5. Obtain trend data at a certain moment
Click [CURSOR] and then 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 below the trend
graph.
10.2 Trend Table Review
The trend table data in the latest 120 hours can be displayed with the resolution of one data every minute,
every 5minutes, 10minutes, 30minutes or 60minutes.
How to enter trend table review window:
2. Select [TREND TABLE] to enter the trend table review window, as shown below:
Figure10-2 Trend table review window
10-2
Review
The following operations can be performed in the trend table review window:
1) 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.
2) Display trend data of different parameters
Press or to show the trend data of the parameters not in current view.
3) Observe earlier or later trend data
Press or to observe the earlier or later trend data respectively.
10.3 NIBPMeasurement Review
This monitor can display the latest 2000 groups of NIBP measurement data in the NIBP measurement
review window.
How to enter NIBP measurement review window:
2. Select [NIBP RECALL] to enter the NIBP measurement review window, as shown below:
Figure 10-3 NIBP measurement review window
Data is displayed in the sequence of time from earlier to later. Each screen can display 10groups of NIBP
measurement data. Select or to view the later or earlier data respectively. Maximum data of2000
groups can be displayed. But if NIBP measurement data are more than2000 groups,the monitor will only
save the latest 2000 groups and theearlier ones will be overwritten.
10.4 Alarm Event Review
Maximum 300 physiological alarm events can be reviewed in the alarm event review window.
10-3
Review
How to enter the alarm event review window:

1. Click the physiological alarm message area;
2. Or click [INFO RECA.] on-screen key;
3. Select [ALARM RECALL] to enter the alarm event review window, as shown below:
Figure10-4 Alarm event review window

The following operations can be performed in the alarm event review window:
(1) Set the starttime
Click [START TIME] and set the start time in the pop-up menu. All the physiological alarm events
occurredafter the start time will be displayed in this windowin chronological order.
(2) Select the alarm event
Click [RECALL EVE.] and select the alarm event in the pop-up list box.Available options include [ALL]
andsperate parameter [FETAL], [ECG], [SpO2], [RESP], [NIBP], [TEMP] and [ARR TYPE].
(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:
Figure 10-5Alarm event review window

10-4
Review
What displayed in this window are follows:

 Alarmtime
 Alarm event
 Alarm level
 The waveform and parameter value at the alarm moment
Attention
 When the alarm events are more than 200, the monitor will only store the latest 200 events
and the earlier ones will be overwritten.
 The alarm log is not maintained when the alarm system is powered down and the time of
powering down is not captured in the alarm log, neither. All the physiological alarm
events will be cleard after the alarm system has experienced a total loss of power for a finite
duration.
10.5 Waveform Review
The monitor can save 120 minute parameter waveform for review in the waveform review window.
How to perform waveform review:
2. Select [WAVE RECALL] to enter the [WAVE RECALL] menu, as shown below:
Figure 10-6 Waveform review menu
3. Set the [RECALL DATE], [RECALL TIME], [END DATE] and [END TIME] respectively.
4. Select [WAVE RECALL] and enter the waveform review window, as shown below:
10-5
Review
Figure10-7 Waveform review window
5. Press or to observe earlier or later parameter waveform respectively.
10-6
Chapter 11 Printing
11.1 Loading Recording Paper
Recorder Roller Recording Paper
Black Mark
Figure11-1Loading the Recording Paper
(1) Pull out the paper tray lightly as the figure above.
(2) Put the recording paper into the paper tray with the grid side facing up and the black mark appearing on
the left of the monitor.
(3) Make the recording paper pass through the recorder roller, pull it out of the paper tray, and then ensure
paper is straight
(4) Push the paper tray in until it is locked.
Note
 Please do not pull the recordingpaper when it is out from the recorder at a constant speed, or
the recorder could be damaged.
 Do not use the recorder without recording paper inside.
11-1
Printing
11.2 Printing
The monitor supports three kinds of printing: real-time printing, frozenprinting and stored patient case
printing.What can be printed under different user screens is different, see the table below:
User Screen Printing contents
Real-time Printing Frozen Printing
Fetal monitoring screen Fetal waveform Fetal waveform
Mother/Fetus monitoring Fetal waveform Fetal waveform
screen
Mother monitoring screen All the maternal All the frozen maternal
parameter waveforms parameter waveforms
List of measured parameter List of measured parameter values
List screen
values
Trend screen All the maternal All the frozen maternal
OxyCRG screen All the maternal All the frozen maternal
Big font screen Fetal waveform None
11.2.1 Real-time Printing
Real-time printing means the printing triggered by pressing the print key on the front panel or clicking the
[PRINT] on-screen key during real-time monitoring.
How to print fetal waveform during real-time monitoring:
1. During real-time monitoring, press the print key on the front panel or click the [PRINT] on-screen key
and enter the [Patient Info & Fischer Grade] window;
2. Confirm the patient information and score results and click [Confirm]. The monitor starts to print the
fetal waveoform according to the speed set in [REAL SPEED] and the time set in [REAL TIME].
3. To stop printing during printing process, just press the print key on the front panel or click the [PRINT]
on-screen key. If [REPORT] is set to [ON], the monitor will output the score report immediately and
then stop printing; if [REPORT] is set to [OFF], the monitor will stop printing immediately.
How to print maternal parameter waveform during real-time monitoring:
1. During real-time monitoring, press the print key on the front panel or click the [PRINT] on-screen key
and the monitor will start printing immediately according to the speed set in [PRINT RATE] and the
time set in [PRINT TIME];
2. To stop printing during printing process, just press the print key on the front panel or click the [PRINT]
on-screen key and the monitor will stop printing immediately.
11.2.2 Frozen Printing
Frozen printing means the printing triggered by pressing the print key on the front panel or clicking the
[PRINT] on-screen key under frozen waveform status.
11-2
Printing
How to print the fetal waveform under frozen waveform status:

1. Under frozen waveform status, press the print key on the front panel or click the [PRINT] on-screen key
and enter the [Patient Info & Fischer Grade] window;
2. Confirm the patient information and score results and click [Confirm]. The monitor will start to print
the frozen fetal waveform from the very left waveform on current screen according to the time length
set in [FREEZE TIME].
3. If the [REPORT] is set to [ON], the score report will be printed after frozen fetal waveform.
How to print the maternal parameter waveform under frozen waveform status:
Under frozen waveform status, press the print key on the front panel or click the [PRINT] on-screen key
and the monitor will start to print the frozen maternal parameter waveform from the very left waveform
on current screen according to the time length set in [PRINT TIME].
11.2.3 Stored Patient Case Printing
Stored patient case printing means the printing triggered by pressing the print key on the front panel or
clicking the [PRINT] on-screen key after loading the patient case and entering patient case review interface.
What can be printed is only fetal waveform.
How to print stored patient case:
1. Access [Case List] window;
2. Select a certain patient case and enter [Patient Review] window;
3. Click [Load] and enter the patient case review interface;
4. Press the print key on the front panel or click the [PRINT] on-screen key and enter the [Patient Info &
Fischer Grade] window;
5. Confirm the patient information and score results and click [Confirm]. The monitor will start to print the
fetal waveform from the very left waveform on current screen according to the time length set in [FREEZE
TIME].
11.2.4 Printing Settings
How to access print setup menu:

1. Access [MAIN MENU] →[MONITOR SETUP] →[PRINT SETUP] and enter the print setup menu;
2. Or click the printer icon and enter the print setup menu.
The items vary with different user screens. The items which cannot be selected means they are not available
under current user screen.
 Click [GRADE] and select [ON] or [OFF] to activate or deactivate the auto scoring function
respectively.
 Click [REPORT], select [ON] and the monitor will print score report after printing fetal waveform;
select [OFF] and the monitor will not print score report.
11-3
Printing
 Click [PAPER TYPE] and select proper paper type. Available paper type includes [COMEN], [PHILIPS]
and [OTHER].
 Click [PRINTER TYPE] and select the printer. Available options include [INLAY PRINTER],
[OUTLAY PRINTER] and [PRINTER IMAGE].
 [INLAY PRINTER] means using the 150mm recorder equipped with the moitor to print and the
print paper is the recording paper.
 [OUTLAY PRINTER] means using the external USB printer to print and the print paper is A4
paper. Supportive external USB printer includes Lenovo LJ2650DN and HP2055d. This item is
only available after connecting the external USB printer to the monitor.
 [PRINTER IMAGE] means the waveform will be saved as picture in USB device and the users
can view it on other devices, for example, computer. The size of the picture is the same as that of
A4 paper. This item is only available after connecting the USB device to the monitor.
The monitor can auto recognize external USB printer and USB device. When connecting the
external USB printer or USB device to the monitor, there will be prompt message “External printer
access” or “USB storage device access”. When connecting the external USB printer, the
[PRINTER TYPE] will auto switch to [OUTLAY PRINTER].
 Click [SCORE SELECT] and select [FHR1] or [FHR2] to score FHR1 or FHR2 respectively.
 Click [Grad Criterion] and select the score criterion, including [KREBS], [Fischer], [Advance Fischer]
and [NST].
 Click [REAL SPEED] and select the print speed for real-time fetal waveform printing. Available print
speed includes [1 CM/MIN], [2 CM/MIN] and [3 CM/MIN].
 Click [REAL TIME] and select the print time for real-time fetal waveform printing. Available print time
includes [1 MIN], [3 MIN], [5 MIN], [10 MIN], [15 MIN], [20 MIN], [30 MIN], [45 MIN], [60 MIN],
[90 MIN], [120 MIN] and [Infinite].
 Click [FREEZE TIME] and select the print time for frozen fetal waveform printing and stored patient
case printing. Available print time includes [1 MIN], [3 MIN], [5 MIN], [10 MIN], [15 MIN], [20 MIN],
[30 MIN], [45 MIN], [60 MIN], [90 MIN], [120 MIN], [150 MIN], [180 MIN], [210 MIN], [240 MIN]
and [480 MIN]. [1 MIN] means the monitor will print fetal waveform of 1 minute from the very
left waveform on the current screen after pressing the print key; and so on.
 Click [PRINT WAVEFORM] and select [ON] or [OFF] to activate or deactivate the function of printing
ECG waveform.
 Click [PRINT RATE] and select the print speed for real-time maternal parameter waveform printing.
Available print speed includes 25.0 mm/s and 50.0mm/s.
 Click [PRINT TIME] and select the print time for real-time maternal parameter waveform printing and
frozen maternal parameter waveform printing. Available print time includes [CONT PRINT](Continual
print), [3s], [5s] and [8s].
During printing, the printer icon will show moving paper , indicating the printing is in process.
11-4
Printing
11.3 Score Criterion
The monitor supports four kinds of score criteria: KREBS, Fischer, Advance Fischer and NST. The
following tables are instructions of the four criteria.
NST score criterion is as follows:
Items 0 point 1-point 2-point Results Score
FHR baseline 100, 180 100 109,161 180 110 160
bpm
FHR upgoing time 0 9 10 14 14
during FM s
FHR upgoing range 0 9 10 14 14
during FM bpm
Variation range 0 4 5 9, 30 10 30
bpm
FM bpm None 10 2 2
KREBS score criterion is as follows:

FHR baseline 100, 180 100 109,161 180 110 160
bpm
bpm
Variation frequency 0 2 3 6 6
cpm
Accelerate None 1 4 4
times/20mins
Decelerate 2 1 2 None
times/20mins
FM bpm None 1 4 4
Advanced Fischer score criterion is as follows:

FHR baseline 100, 180 100 109,161 180 110 160
bpm
bpm
cpm
Accelerate None 1 4 4
times/20mins
Decelerate Decelerate Slight variation None
times/20mins later or severe
variation
Fischer score criterion is as follows:

FHR baseline 100, 180 100 109,161 180 110 160
bpm
bpm
11-5
Printing
bpm
Accelerate None Periodic acceleration Non-Periodic
times/20mins acceleration
Decelerate Decelerate Slight variation none
times/20mins later or severe
variation
Attention
 Diagnosis results output by doctors are only selectable software functions of the
monitor, which can only be reference to doctors’ clinical diagnosis. Doctors should make
diagnosis based on the actual waveforms and then sign to confirm. Doctors are responsible
for the conclusion of the output reports.
11-6
Chapter 12 Cleaningand Disinfection
Use only the substances approved by Comen and methods listed in this chapter to clean or disinfect your
equipment. Warranty does not cover the damage caused by unapproved substances or methods.
Comen 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.
12.1 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 the manufacturer’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).
12.2 Cleaning and Disinfection of the Monitor and Accessories
To avoid cross infection, please clean the monitor and accessories after each use. Please understand the
relevant regulations about equipment cleaning in your hospital before cleaning.
Steps of cleaning:
1. Turn off the monitor,
2. Disconnect the power cord and accessory cable from the monitor;
3. Clean the display screen and the enclosure of the monitor and plug-in modules with a soft cloth
moistened (not wet) with cleaning agents;
4. Clean the accessory cable and sensor with a soft cloth moistened (not wet) with cleaning agents;
5. After cleaning, wipe off the cleaning agent with a dry soft cloth;
6. Allow the monitor, accessory cable and sensor to air dry.
To avoid damage to the monitor and accessories, disinfection is recommended only when regulated as
necessary in the Hospital Maintenance Schedule. Please wash the monitor and accessories first before
disinfection.
12-1
Maintenance and Cleaning
The recommended cleaning agents and disinfectants for the monitor and accessories are listed in the
following table:
Components Selectable Cleaning Agents Selectable Disinfectants
Isopropyl alcohol(70%), Hydrogen
Isopropyl alcohol(70%),
peroxide
Monitor enclosure Glutaraldehyde solution(2%),
Sodium hypochlorite
Isopropyl alcohol(70%), Hydrogen Isopropyl alcohol(70%),

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

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

Temperature
(with chlorine bleaching powder and Glutaraldehyde solution(2%),
probe
3% water), Hydrogen peroxide Sodium hypochlorite
Isopropyl alcohol(70%) Glutaraldehyde solution(2%),

SpO2 sensor
Sodium hypochlorite
TOCO transducer Glutaraldehyde solution(2%),
Sodium hypochlorite
FHR transducer Glutaraldehyde solution(2%),
Sodium hypochlorite
FM marker Glutaraldehyde solution(2%),
Sodium hypochlorite
Wake probe Glutaraldehyde solution(2%),
Sodium hypochlorite
Mainstream CO2 Isopropyl alcohol(70%), Hydrogen Glutaraldehyde solution(2%),

module peroxide Sodium hypochlorite
Sidestream CO2 Isopropyl alcohol(70%), Hydrogen Glutaraldehyde solution(2%),

module peroxide Sodium hypochlorite
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.
12-2
 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.
12.2.1 Cleaning and Disinfection of the Cuff
Take out the rubber bag before cleaning the cuff.

The cuff can be hand washed or machine washed in warm water or with mild detergent. Hand wash can
extend the service life of the cuff. Air dries the cuff after cleaning.
The cuff may be disinfected with a cloth moistened with 70% ethanol or 70% isopropanol. Prolonged use of
disinfectant may cause discoloration of the cuff.
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.
12-3
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:
12.2.2 Cleaning the Belt
The belt should be cleaned with soapy water with warmth lower than +60 .
12-4
Chapter 13 Maintenance
13.1 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 the manufacturer.
(f) Check the battery.
(g) If the monitor is equipped with a recorder, 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 Comenas per customer demands. Qualified
technicians can use it to help the user repair some apparatus that Comen 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.
13.2 Maintenance Schedule
The following safety and maintenance check can be conducted by professional persons approved by Comen.
You can contact the customer service technicians if you need the following maintenance. Before the
inspection or maintenance, the facilities should be cleaned and disinfected.
13-1
Fetus Monitoring
Check and maintenance items Frequency
Safety check according to IEC 60601-1 At least once a year. Or after monitor falling, power
requirements replacement, or as required.
NIBP air leakage test At least once a year or as required.
NIBP calibration
ECG calibration
At least once a year or when you doubt the measured value.
The performance of all measuring
functions
Touch screen calibration At least once a year or after changing the touch screen.
Battery See the section on battery for reference
13.3 ECG Calibration
During the use of monitor, ECG calibration is required when the ECG signal is inaccurate. ECG calibration
should be conducted by the serviceman approved by Comen at least once a year or when you doubt the
measured value. Specific steps are as follows:
1. Press ECG parameter area, in the pop-up [ECG SETUP] menu, press [ECG CAL]. Then the screen
displays square wave signal and displays prompt message “ECG CALIBRATING….”.
2. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
3. After calibrating, press [STOP CAL].
Warning
 Please do not monitor patients during ECG calibration.
13.4 NIBP Air Leakage Test
It is used to check if the NIBP measuring pump has a leak. If the leakage test is passed, the system will not
give any prompt; if not, there will be a corresponding error prompt in the NIBP information area.NIBP air
leakage test should be conducted by the serviceman approved by Comen at least once a year or when you
doubt the measured value.
Leakage test process:
(1) Connect the cuff and NIBP to the openning of the monitor.
(2) Wrap the cuff around a cylinder with proper size, as the figure shows.
13-2
Fetus Monitoring
Cylinder
Patient
Monitoring
NIBP Pressure line

Cuff
(3) Enter [NIBP SETUP] menu.

(4) Select [PNEUMATIC] and the monitor starts to perform NIBP air leakage test with [PNEUM
TESTING…]status message displayedin the NIBP parameters area.
(5) System automatically inflates to the pressure of 180mmHg.
(6) After about 20 seconds, the system will automatically open the valve, which means leakage
measurement is complete.
(7) If there is no error message in the NIBP parameter area, it means that the system has no sign of air
leakage. If error message [Pump Leaking…] is displayed, it means that the air circuit may have an
air leakage fault. Under such a circumstance, the operator should check the entire connection for
loosening, and run the leakage test again after having made sure that the connection is errorless.
(8) If the error message still appears, please contact the manufacturer for repair.
Warning
 This air leakage test, different from those described in the standard EN 1060-1, is for users to
simply test air leakage in NIBP inflation. If the system displays an error message [Pump
Leaking…] at the end of testing, please contact the Comen maintenance engineers.
13.5 NIBP Calibration
Calibration of NIBP measurements should be carried out once a yearor when you doubt the measured NIBP
by the serviceman approved by Comen.
Manufacturers recommend a calibrated pressure gauge (or mercury sphygmomanometers) with a precision
more than 1mmHg to be used for calibration. Select [Maintenance], enter the pasrword, and select
[Calibration] to begin calibration and this item becomes [Stop Calibration].
Pressure sensor calibration steps:
Metal containers with a volume of 500ml ± 5% instead of cuffs. Connect a calibrated standard gauge with
measurement error of less than 0.8mmHg, a spherical air pumps with a t-interface and inflatable tubes
attached to NIBP jack on the module. Set the monitor to "calibration" mode, and then inflate the metal
containers with ball type air pump to pressure of 0,50 and 200 mmHg respectively. The difference of
pressure value between standard pressure gauge and monitor should be within the 3mmHg. Otherwise,
13-3
Fetus Monitoring
please contact the Comen maintenance engineer.
Patient Standard pressure

Monitoring
meter
NIBP
Gas pipe
Round pump Metal vessel
13.6 Touch Screen Calibration
Touch screen calibration should be conducted at least once a year or when the touch screen is insensitive or
after changing the touch screen. Calibration methods are as follows:
1. Enter [MAIN MENU].
2. Press [MAINTENANCE] and enter the password.
3. Press [SCREEN ADJUST].
4. Press the five symbols one by one following the indication on the screen
5. After calibration, the system will return to main screen automatically.
13-4
Chapter 14 Fetus Monitoring
There are two basic types of fetus monitors: antepartum monitor for pre-delivery use and intrapartum
monitor for in-delivery use. The antepartum monitor does not have the internal monitoring ability and thus
can not monitor the fetal heart rate (FHR) directly through the fetus scalp electrode or monitor the internal
uterine pressure (IUP) of the mother through the internal pressure pipe. It monitors the FHR by connecting
the ultrasound transducer to the mother’s abdomen and monitors the uterine pressure by connecting the
TOCO Transducer to the bottom of the mother’s uterus.
14.1 Difference between Antepartum and Intrapartum Monitor
The antepartum monitor ensures the accuracy and reliability for FHR measuring by using the high-sensitivity
ultrasound transducer, high-performance signal processing circuit and advanced FHR calculation method.
The intrapartum monitor is acceptable to few pregnant women as it is not easy to operate, not cost effective
(use one-off electrode or pressure pipe) and likely to cause trauma to the patient.
14.1.1 Antepartum Monitoring Principles
Below is the ultrasound Doppler FHR monitoring principles:

The Doppler FHR monitoring is supported by the Doppler Effect. The ultrasound wave will be
reflected when meeting any obstacle in the propagation process. If the obstacle is still, the reflection
frequency will be identical with the transmitting frequency. If the obstacle moves, the reflection
frequency will change: become higher (or lower) when the obstacle faces the sound source with the front (or
back). The faster the obstacle moves, the greater change the reflection frequency will experience. That is
the Doppler Effect. In clinical application, the ultrasound transducer is used to transmit the ultrasound wave
into the human body. When the ultrasound wave meets any locomotive organ (like heart), the echo
signals will be changed and processed to collect the heart rate information which indicates the heart
activities.
It is the best time to do the Doppler FHR monitoring when the fetus faces the mother’s abdomen with the
back. If the fetus faces the mother’s abdomen with the front, his/her arms and legs will impact the echo
signals. When the fetus turns, his/her heart will deviate from the irradiation area of the transducer to
cause weaker echo signals and reduced Doppler Effect.
14-1
Fetus Monitoring
14.1.2 Terms about Fetus Monitoring
Continuous wave working mode: the receiver and transmitter of the ultrasound transducer work
simultaneously and continuously; faster or lower sometimes; simple circuit; can not recognize the distance of
the target; likely to include other noise; large transmitting power; small effective receiving area (transducer).
UltrasoundTransmitting Ultrasound Receiving

UltrasoundTransmitting
Mother’s Abdomen
Depth
Figure14-1Continuous Wave Transmitting/Receiving
Pulse wave working mode: small transmitting power; large effective receiving area (transducer); can receive
the ultrasound signals of a selected depth; can eliminate other interference and noise; complex circuit.
The transmitting frequency used for fetus monitoring is usually 1MHz~3MHz. A higher (or lower)
transmitting frequency will lead to a weaker (or stronger) penetrability and a higher (or lower) resolution for
tissue structure. Therefore, the transmitting frequency of the ultrasound transducer used for superficial
vascular disease diagnosis can reach 810MHz. According to national safety standards, the transmitting
power of the ultrasound transducer should not exceed 10MW/cm2; otherwise the fetus tissue could be
affected adversely.
14.2 FHR Monitoring
14.2.1 Connect the FHR Transducer
(1) Let the patient lie on her back with the belt placed under her back, and then use the FHR transducer to
find the position of the fetal heart.
(2) Apply conductive gel to the contact surface of the transducer to ensure the largest FHR monitoring area.
Before applying the transducer to the pregnant woman, please apply conductive gel to the middle 2/3
part of the contact surface. The conductive gel will be pressed to cover the whole contact surface after
the transducer is fixed to the pregnant woman’s abdomen.
14-2
Fetus Monitoring
Figure14-2 FHR Transducer
(3) Connect the ultrasound transducer to the abdomen of the pregnant woman and then adjust its position
until you find the loudest fetal heart signal.
(4) Fix the ultrasound transducer with the belt.
Note
 Make sure the belt is tied to the proper position with proper tightness.
(5) Make sure you can hear the fetal heart beats in the monitoring process. Do not adjust FHR volume to
zero. The FHR curve is not reliable without strong fetal heart signals.
(6) If there is any strong fetal movement or uterine contraction or the pregnant woman moves her body, the
fetal heart position may change a lot. Please check whether you can hear clear fetal heart beats from
time to time. If not, please adjust the position of the ultrasound transducer to find the loudest fetal heart
signals again.
14.2.2 Cross-Channel Verification
The fetus is not necessarily alive even if the fetal heart rate is detected, because the ultrasound transducer
may collect signals from other sources, like the mother’s heart, aorta, or large vessel pulsation.
During fetus monitoring, if the monitored heart rates (from a fetal or mother) coincide at any time, the same
heart rate is probably being monitored by more than one transducer. The corss-channel verification feature is
helpful to detect whether the same heart rate is being monitored by more than one transducer.
How to activate the cross-channel verification feature:
1. Select FHR waveform and the [FHR SETUP] menu will be displayed;
2. Select [CROSS DUR] and adjust the duration for cross-channel verification. Available duration includes
[OFF], [30 S], [60 S], [90 S] and [120 S]. [OFF] means the monitor will not give alarms even though
the monitored heart rates coincide; [30S] means when the monitored FHR1 and FHR 2 (or the
monitored fetal heart rate and maternal heart rate) coincide for more than 30 seconds, the monitor will
give a high level technical alarm.
3. Select [CROSS ERROR] and select the allowable error for cross-channel verification. Available options
include [0bpm], [1bpm], [2bpm], [3bpm], [4bpm] and [5bpm]. [0bpm] means once the monitored FHR1
and FHR 2, or the monitored fetal heart rate and maternal heart rate coincide for more than the time set
in [CROSS CUR], the monitor will give a high level technical alarm; [1bpm] means when the
difference between the monitored FHR1 and FHR 2 (or the monitored fetal heart rate and maternal
14-3
Fetus Monitoring
heart rate) is less than or equal to 1bpm and lasts for more than the time set in [CROSS CUR], the
monitor will a high level technical alarm.
The technical alarm message is [ADJT ULTRAS POSITION](Adjust the positions of ultrasound transducers )
and the FHR1 and FHR2 parameter area will display “_ _” at the same time.
14.2.3 Trace Separation
The trace separation function is to help you interpret traces with similar baselines.
 Enable Trace Separation
Select FHR waveform, in the pop-up [FHR SETUP] menu, select [FHR OFFSET] and select [+20bpm]
or [-20bpm]. [+20bpm] or [-20bpm] means the FHR2 trace is displayed and recorded 20bpm higher or
lower than it really is respectively. The FHR2 trace recorded on the recording paper is thinner with light
color.
Take +20bpm offset as an example, see the figure below:
Figure 14-3 Trace separationenabled
The FHR2 trace on the recording paper has an offset, but the FHR2 value on the screen remains
unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For example, if the
recorded FHR2 trace is 180bpm, the true FHR2 is 160bpm.
 Disable Trace Separation
Select FHR waveform, in the pop-up [FHR SETUP] menu, select [FHR OFFSET] and select [+0bpm].
The FHR2 trace recorded on the recording paper is thinner with light color, and the FHR2 trace is the
true one, see the figure below:
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Fetus Monitoring
Figure14-4Trace separationdisabled
14.2.4 FHR Settings
14.2.4.1 Setting the Source of Maternal Heart Rate
Besides the FHR waveform, there is one maternal heart rate waveform displayed in the FHR waveform
area, which helps the users to record the FHR waveform and maternal heart rate waveform together.
How to set the source of maternal heart rate:
1. Select FHR waveform area and the [FHR SETUP] menu will be displayed;
2. Select [MHR] and select the source of maternal heart rate from [OFF], [HR], [PR] and [AUTOMATIC].
 [OFF] means the function of displaying maternal heart rate waveform in the FHR waveform area will
be deactivated;
 [HR] means the source of maternal heart rate is the measured maternal heart rate;
 [PR] means the source of maternal heart rate is the measured maternal pulse rate;
 [AUTOMATIC] means the monitor will auto select the measured maternal heart rate or pulse rate as the
source of maternal heart rate.
The users can also set the display color for maternal heart rate waveform by entering [FHR SETUP] menu
and selecting [MHR DISP COLOR].
14.2.4.2 Setting the FHR Sound Channel
FHR sound channel means which channel the FHR sound comes from. The available options include [FHR 1]
and [FHR2]. When there is only one FHR transducer connected, the FHR sound channel will be locked as
[FHR1] and when there are two FHR transducers connected, the users can select the FHR sound channel as
needs.
How to set the FHR sound channel:
1. Select FHR1 parameter area, select [Sound channel] and select [FHR1] or [FHR2];
2. Select FHR2 parameter area, select [Sound channel] and select [FHR1] or [FHR2];
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Fetus Monitoring
14.3 TOCO Monitoring
The TOCO indicates the delivery strength. The uterine contraction has been clinically proven to impact the
fetal heart activities and delivery. The recorded TOCO trace provides such information as the strength,
frequency, duration, regularity and shape of uterine contraction. The uterine contraction can increase or
reduce the FHR. The monitor can monitor the TOCO of the mother in the fetus monitoring process, so the
doctor can diagnose the FHR changes as per the uterine contraction.
The external pressure monitoring is to monitor the TOCO through the mother’s abdomen. In case of any
uterine contraction, the tension of the abdominal wall will compress the TOCO transducer, which will
convert such compression into electrical TOCO signals. The electrical TOCO signals will be magnified by
the monitor for you to view or print.
TOCO Transducer
Uterus
Figure14-5 TOCO Measuring
14.3.1 Connect the TOCO Transducer
(1) Make the belt pass through the back of the TOCO transducer, place the TOCO transducer at the bottom
of the patient’s uterus, and then tie the belt to the proper position with proper tension.
Figure14-6 TOCO Transducer
(2) Perform TOCO zeroing with one of the following three methods:
 Enter [TOCO SETUP] menu and select [TOCO BASE];
 Or click the [TOCO BASE] on-screen key;
 Or press the TOCO zero key on the front panel.
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Fetus Monitoring
(3) When the TOCO transducer is placed on the pregnant woman, please observe the TOCO value on the
screen.
14.3.2 Setting the TOCO Zero Value
1. Select the TOCO waveform area or parameter area and the [TOCO SETUP] menu will be displayed;
2. Select [TOCO Base] and select the TOCO zero value from 0, 5, 10, 15 and 20.
If you set [TOCO Base] to 0, the minimum TOCO value will be 0 after zeroing. This operation will also zero
the trace on the screen.
14.4 FM Counting
14.4.1 Counting FM Manually
Counting FM manually means let the pregnant woman hold the FM marker and press it when she feels any
FM.
Figure14-7 Manual FM Mark
The FM mark displayed on the screen is with green color and the FM mark recorded by the recorder is
“M”.
Attention
 The pregnant woman should press the FM marker when a fetal movement starts and should
not press it again until such fetal movement ends.If the pregnant woman presses the FM
marker serval times during 10 secords, only one FM mark will be displayed on the screen.
14.4.2 Counting FM Automatically
Counting FM automatically means the monitor will auto count the FM according to the FM threshold value
and clinical situations. Please place the FM marker at the place where is no interference and impact.
The FM mark displayed on the screen is with the same color as that of the AFM (Auto Fetal
Movement) waveform. To change the AFM color, select TOCO waveform area, enter the [TOCO SETUP]
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Fetus Monitoring
menu and select [AFM COLOR]. The FM mark recorded by the recorder is “T”.
14.4.3 Setting the FM Sensitivity Threshold
The FM sensitivity threshold means auto FM counting sensitivity. For example, if you set it to 10%, the
system will auto countthe FM once (only once within 8 seconds) when the auto FM trace value is greater
than 3. See the table below for more information:
FM Threshold AFM trace value(bpm)
10% >3
20% >5
30% >10
40% >15
50% >20
60% >25
70% >30
80% >35
How to set the FM Threshold:
(1) Select TOCO parameter area or waveform area and the [TOCO SETUP] menu will be displayed;
(2) Select [FM Limen] and select [10%], [20%], [30%], [40%], [50%], [60%], [70%], or [80%].
14.4.4 Setting the FM Counting Mode
There are two kinds of FM counting mode supported by the monitor, [Auto/Manual] and [MANUAL].
 [Auto/Manual] means the monitor can count the FM automatically according to the clinical situations
and also the pregnant woman can hold the FM marker and count the FM manually when she feels the
fetal movement.
 [MANUAL] means the pregnant woman holds the FM marker and counts the FM manually when she
feels the fetal movement.
How to set the FM counting mode:
 Select FHR waveform area, in the pop-up [FHR SETUP] menu, select [Fetal Move.] and select the FM
counting mode;
 Or select FHR1 or FHR2 parameter area, in the pop-up [FHR1 SETUP] or [FHR2 SETUP] menu, select
[Fetal Move.] and select the FM counting mode.
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Fetus Monitoring
14.5 Fetus-awakening Vibratory Stimulator
The fetus-awakening vibratory stimulator is designed to awaken the fetus during ultrasound examination.
10.4.1 Appearance Introduciton
Figure14-8 Front View
Figure14-9Side View
Power switch
Fast: press to increase the vibration speed.
Speed level: level 3 to level ∞ (infinite level). Level 3 is the minimum level.
Slow: press to decrease the vibration speed.
Cable: to connect the monitor.
Vibration part.
Battery: Two AA batteries.
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Fetus Monitoring
Attention
 The fetus-awakening vibratorystimulator cannotcontact with the pregnant women’s skin
directly.When using the vibratorystimulator, its vibration part should be coated with one layer of
disposable medicalgauzeand stuck firmly with medical proof fabric. Replace gauze for each
patient to avoid cross infection.
 The surface temperature of the vibration part may exceed 41 but won’t exceed 43 .
14.6 Timed Monitoring
The monitor supports timed monitoring (Mainly for fetus monitoring) and manual real-time monitoring. The
patient monitoring will also ends when the timed monitoring ends.
Users can view the timed monitoring information on the screen directly:
2
1 3
1. Show whether there is prompt when the timed monitoring ends. means the monitor will give a high
level technical alarm with alarm message of “***MONITOR STOP” when the timed monitoring ends.
means the monitor will not give any alarm when the timed monitoring ends.
2. Show the duration of this timed monitoring, for example 10 minutes.
3. Show the elapsed time of this timed monitoring, for example, the elapsed time of this timed monitoring
is 58 seconds.
How to start timed monitoring:
1. Click the timed monitoring information area on the screen, or click [TIMER] on-screen key, and the
[TIMER] menu will be displayed;
2. Select [TIME END PROMPT] and toggle between [ON] and [OFF]. [ON] means the monitor will give
a high level technical alarm when the timed monitoring ends.
3. Select [TIMING CARE] and select the duration for timed monitoring from 10 minutes to 120 minutes.
4. Select [STARUP TIMER] and the timed monitoring starts. The [STARTUP TIMER] changes to [STOP
TIMER] and the item [CLEAR TIMER] will be displayed in the [TIMER] menu.
5. During timed monitoring, to stop monitoring, select [STOP TIMER]. The [STOP TIMER] changes to
[STARTUP TIMER]. At this time, select [STARTUP TIMER] again and the monitor will continue the
timed monitoring till it ends.
6. Select [CLEAR TIMER], the timed monitoring will end immediately and the item [CLEAR TIMER]
disappears.
7. Select [STARTUP TIMER] again, a new timed monitoring will start.
During timed monitoring, the recorder will continuously output the fetal waveform till the timed monitoring
ends. To stop printing during timed monitoring, press the print key on the front panel or click [PRINT]
screen key, the printing will stop immediately and the timed monitoring will also ends.
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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 valueso 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 waveformscan be
displayed according to different lead wires.
15.2 ECG Display
2 3 4 6
Figure 15-1 ECG display
1. ECG lead name

2. Waveform gain
3. Filter mode
4. 1 mV scale
5. The alarm limits
6. ECG measured value
7. ECG Waveform
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ECG Monitoring
Warning
 The operators shall not touch the patients, tables and instruments during defibrillation.
 Only use the ECG lead wire specified by Comen.
 Pacemaker failure: during the heart’s complete conduction blockage or when pacemaker
can't wrestle/took away,the high P waves (larger than the 1/5 of the average height of R wave)
may be wrongly counted by the monitorleading to asystoles being undetected
 During the defibrillation, the ECG cable connected with patient may be damaged. Before
reusing these cables, check whether its function is normal.
 After defibrillation, the ECG waveform will recover within 5 seconds without losing any stored
data. For electrosurgery (ESU) or defibrillation, measurement accuracy may temporarily drop,
but it does not affect the safety of patients or equipment
 Never expose the equipment under x-ray or strong magnetic field (MRI)
 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 audio alarm anddisplayalarm message "ECG LEAD
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.
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ECG Monitoring
15.4 Steps of Monitoring
15.4.1 Preparation
Ask the patient to remove outer clothing on upper body:

(a) As skin is poor conductor of electricity, to get a good contact of the electrode and the skin, it is
important to make preparation of the patient s' skin.
(b) If necessary, shave the area for the electrode.
(c) Thoroughly clean the skin with soap and water.(Do not use ether or pure alcohol, because they will
increase the resistance of the skin).
(d) Dry and rub the skin in order to increase the capillary blood flow and remove skin debris and oil.
(e) Attach the alligator clip prior to placement of the electrode.
(f) Place electrodes on the patient. If the electrodes used do not have conductive gel, apply the
conductive gel before placement.
(g) Connect the electrode lead and the patient cable.
(h) Check that the monitor power is on.
15.4.2 Placement of ECG Electrodes
15.4.2.1 Identifiers and Color Code of Electrodes
The table below shows the lead names in the European and American standards. (The leads are represented
by RA, LA, RL, LL, and V in the American standard, while by R, L, N, F, and C in the European standard.):
Identifier and color code of 3-lead and 5-lead electrodes are as follows:
American standard European standard
Name of lead Color Name of lead Color
RA White R Red
LA Black L Yellow
LL Red F Green
RL Green N Black
V brown C White
Identifier and color code of 12-lead electrodes are as follows:

American standard European standard
Lead Marking Color Marking Color
Right arm RA White R Red
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ECG Monitoring
Left arm LA Black L Yellow
Right foot RL Green N or RF Black
Left foot LL Red (f) Green
Chest 1 V1 Red C1 Red
Chest 2 V2 Yellow C2 Yellow
Chest 3 V3 Green C3 Green
Chest 4 V4 Blue C4 Brown
Chest 5 V5 Orange C5 Black
Chest 6 V6 Purple C6 Purple
15.4.2.2 Placement of 3-lead ECG Electrodes
The position of electrode of 3-lead ECG cable is divided into American standard and European standard:
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.
Red/green (left leg) electrodes - placed in the left lower abdomen.
Figure15-2 Positions of 3-lead ECG electrodes
15.4.2.3 Placement of 5-lead ECG Electrodes
The position of electrode of 5-lead ECG cable is divided into American standard and European standard:
Green/black (right leg) electrodes – placed at the right lower quadrant.
Brown/white (chest) electrode-as on the chest wall
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ECG Monitoring
Figure15-3 Positions of 5-lead ECG electrodes
As with 5-lead ECG cable, the chest lead electrodes should be put in one of the positions as follows:
V1: in the fourth intercostal space on the right edge of the sternum.
V2: in the fourth intercostal space on the left edge of the sternum.
V3: in the middle position of V2 and V4.
V4: in the fifth intercostal space of the left mid-clavicular line.
V5: at the left anterior axillary line, with horizontal position the same as the V4.
V6: at the left median axillary line, with horizontal position the same as the V4.
V3R-V6R: in the right chest wall, with its position corresponding to the left position.
VE: at the eminence of xiphoid.
V7: in the fifth intercostal space of left posterior axillary line on the back.
V7R: in the fifth intercostal space of right posterior axillary line on the back.
Figure 15-4 Position of Chest electrode of 5-lead ECG cable
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ECG Monitoring
15.4.2.4 Placement of Reformed 12-lead ECG Electrodes
The position of electrode of 12-lead ECG cable after being improved is divided into American standard and
European standard.
Green/black (right leg) electrodes – placed at the right lower quadrant.
Figure 15-5Position of electrodes of 12-leadECG cable
The chest electrode placement sites are generally six, taking spatiuminterosseum of costal bone as the
locating basis, 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 left
mid-clavicular line
V5/C5: at the parallel previous axillary line of C4 level on the left
V6/C6: at the parallel median axillary line of C4 level on the left
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ECG Monitoring
Figure 15-6Position of chest electrodes of 12-lead ECG cable
15.4.2.5 ECG Lead Connection Recommended for Surgical Patients
Warning
 When using electricity surgical unit (ESU), put the ECG electrode at the middle position
between ESU earth plate and electrosurgical knife to avoid burn. The cable of electricity
surgical unit and the ECG cable can't be entangled.
 In the use of electricity surgical unit (ESU), never allow the electrodes to be close to the earth
plate of electricity surgical unit, or ECG signal would be interfered seriously.
The position of ECG lead depends on the type of surgery. For example, for the thoracotomy, electrode can
be put on the chest or the back. In the operating room, because of usingelectrosurgical 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 beingput on the upper arm, or ECG wave will become
very small.
15.5 Waveform quality
Users can choose to display the ECG waveform with the best signal.
Feature of a good signal:
 Tall, narrow and without notch.
 R wave tall, completely above or below the baseline.
 T waves less than 1/3 height of R wave.
 P wave should be much smaller than T wave
In order to obtain 1 mV calibration ECG waveform,ECG calibration should be conducted. During ECG
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ECG Monitoring
calibration, the screen displays the status message “ECG Calibrating……”.
Figure 15-7Standard ECG waveform
15.6 ECG Settings
15.6.1 Setting the Lead Type
This monitor is applicable to the 3-lead, 5-lead and 12-lead ECG monitoring. When ECG cables of different
leads are used, the ECG leads that can be monitored are different.
When using 3-lead ECG lead wire, the leadscan be monitored include I, II and III.
When using 5-lead ECG lead wire, the leadscan be monitored include I, II, III, aVR, aVL, aVF and V1.
When using 12-lead ECG lead wire, the leadscan be monitored include I, II, III, aVR, aVL, aVF, V1 and V2,
and V3, V4, V5and V6.
When using the 3-lead ECG lead wire, only one channel ECG waveform can be displayed on the
screen; while when using the 5-lead or 12-lead ECG lead wire, only one ECG waveform can be displayed on
the fetal /mather monitoring screen and big font screen, and ECG waveform of two channels can be
displayed on the mother monitoring screen, trend screen, list screen and oxyCRG screen.
Steps for setting the lead type:
(a) Click ECG parameter area and [ECG SETUP] menu will be displayed;
(b) Set the [LEAD TYPE] to [3 LEADS], [5 LEADS] or [12 LEADS].
15.6.2 Setting the Lead Name
(a) Click ECG waveform and [ECG WAVE] menu will be displayed;
(b) Click [LEAD NAME] and select the lead name from the pop-up list box, for example, lead II.
15.6.3 Setting the Gain
Gain is used to adjust the size of ECG waveform.Available gains include× 0.25 × 0.5 × 1, × 2 and auto.Auto
mode automatically adjusts the gain by the monitor. The right side of each ECG waveform channel has given
1mv scale. The height of the 1mV scale is proportional to the amplitude.
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ECG Monitoring
(b) Set [GAIN] to [× 0.25], [× 0.5], [× 1], [× 2] or[AUTO]
Attention
 When the input signal is too large, the peak may be truncated. The user can refer to the
actual waveform to manually change the gain of the ECG waveform in order to avoid the
incomplete waveform display.
15.6.4 Setting the Filter Mode
There are four filter modes: diagnostic mode, monitor mode, surgical mode and ST mode. The diagnostic
mode shows unfiltered ECG wave; the monitor modecan filter out the artifacts which may lead to false
alarms. The surgical mode in the operating room can reduce the artifact and interference from electrical
surgical unit. Filter mode is displayedabove the first ECG waveform.
ST filter mode is user-friendly to conduct more accurate ST segment measurements. Frequency response
range of this mode is 0.05Hz-40Hz.The good scalability of low frequency ensures undistorted interpretation
of patient’s ST segment, and can effectively filter high-frequency interference signals over 40Hzincluding
power frequency interference. In this mode the user can more accurately acquire the measured ST segment
value by adjusting the position of the ST segment analysis points.
(b) Set [FILTER] to [DIA] (diagnostic), [MON] (monitor), [SUR] (surgical) or [ST];
Warning
 Only under diagnostic mode will the actual ECG signal be provided. Under monitor mode and
surgical mode,ECG waveforms have varying degrees of distortion, and at this time, the system
can only provide the basic status of ECG signal, which may have a great impact on the result
of the ST segment analysis. Under surgical mode, the arrhythmia analysis result is also
affected to some degree. So we recommended that when the interference is small, try to use
the diagnostic mode to monitor the patient.
15.6.5 Setting the Calculation Channel
Heart rate calculation channel means the waveform from which lead is used to calculate heart rate.
Calculation channel options vary with different lead types:
For 3-lead ECG cable, the default calculation channel is lead I.
For 5-lead ECG cable,the available calculation channel includes I, II and V.
For 12-lead ECG cable, the available calculation channel includesI,II,V1, V2, V3, V4, V5 and V6.
(a) Select ECG parameter areaand the [ECG SETUP] menu will be displayed;
(b) Select[HR CHANNEL]and select the lead from the pop-up list box.
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ECG Monitoring
15.6.6 Setting the Heart Rate Source
(a) Select ECG parameter area and the [ECG SETUP] menu will be displayed;
(b) Set [HR FROM] to[ECG], [SpO2] or [AUTO].
 [ECG] means the heart rate is calculated based on the ECG waveform and HR value will be the alarm
source;
 [SPO2] means the heart rate is calculated based on the PLETH waveform and SpO2 value will be the
alarm source;
 [AUTO] means the monitor would decide the HR source based on the signal quality.
15.6.7 Setting the Notch
Notch inhibits the 50Hz or 60Hz frequency components of signals collected. When the filter mode is not the
diagnostic mode, the system automatically enables the notch; while when filter mode is the diagnostic mode,
the user should select to enable or disable the notch fucntionaccording to the need.
(a) Select ECG parameter areaand the [ECG SETUP] menu will be displayed;
(b) Select [NOTCH] and toggle between [ON] and [OFF].
15.7 ST Segment Analysis
15.7.1 About ST Segment Analysis
The normal heart beat and atrioventricular pacing are used for ST segment analysis. The monitor analyzes
these heart beats and calculates the elevation and depression of the ST segment. The monitor can display the
information in ST numerical form. It can continuously monitor all available leads. For ST-segment analysis,
the ECG waveform is not required to be displayed on the monitor. For ST analysis,it usually uses a special
filter which ensures diagnostic quality. If you use the diagnostic filter mode to monitoring ECG, the ST
segment of the ECG wave will be slightly different from the ST segment in the ST fragment with the
same waveform. In order to diagnostically assess the ST-segment, please always switch to ST filter mode.
You can also select the monitor or surgical filter mode, but ST-segment data will have a serious distortion.
ST segment analysis can measure the elevation or depression of the specified ST-segment of a lead.
Meaning of ST-segment measurement: A positive number indicates the elevation, a negative number
indicates depression
Measurement range of the ST segment: -2.0 ~ +2.0 mV.
15.7.2 Impact on ST Segment
Some clinical conditions makeit difficult to get reliable ST monitoring, such as:
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ECG Monitoring
 Unable to obtain the leads with low noise;

 The irregular baseline resulting from arrhythmia such as atrial fibrillation / atrial flutter;
 The patient is continuous ventricular pacing
 Patients have left bundle branch block
When these things happen, you should consider to turning off ST monitoring
Warning
 The clinical significance of ST level change information provided by this monitor should be
decided by the physician.
15.7.3 Enabling ST Segment Analysis
(a) Select ECG parameter area;

(b) Enter the [ST ANALYSIS]menu;
(c) Set [ST ANALYSIS] to[ON] or [OFF].
When it is set to [ON], ST value would be displayed in the ECG parameter area.
15.7.4 Adjusting the ST Segment Analysis Point
Set the ST measurement point as R peak point.The ST measured values of every cardiac integrated wave is
the vertical distance between the peak point and the two measurement points, as shown below:
R Wave
P T
}DIF = ST Value
Q
S
ST Measuring Point
BP: ISO
Initial Value +109 ms
-78 ms +109 ms
Figure 15-8 ST analysis point
Attention
 If the patient's heart rate or ECG waveform changes obviously, you need to adjust the location of
ISO and ST point. The abnormal QRS complex are not considered when 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.
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ECG Monitoring
 The ISO cursor is to decide the equipotentialpoint 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.
Figure 15-9 ST segment analysispoint
Warning
 Please ensure that the location of the ST measurement points suitable for the patients.
15.8 Arrhythmia Analysis
Arrhythmia analysis is used for the clinical monitoring of patients’ ECG to detect changes in heart rate and
ventricular premature beat, to save the arrhythmic events and to generate alarm information. Arrhythmia
analysis can be used to monitor pacemaker and non-pacemaker patients.Doctors may, based on the
arrhythmia analysis, evaluate the patient's condition (such as heart rate, the PVCs (premature ventricular
contraction) frequency, rhythm, and abnormal heartbeat) and give the appropriate diagnosis and treatment. In
addition to the detection of ECG changes, the arrhythmia analysis can also be used to monitor patients and
give appropriate alarms.
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ECG Monitoring
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 15 kinds of arrhythmia analysis.Arrhythmia analysis system will store 200 alarm
events for review.
15.8.1 Enabling Arrhythmia Analysis

(b) Enter the [ARR ANALYSIS]menu;
(c) Select [ARR ANALYSIS] and toggle between[ON] and [OFF].
15.8.2 Arrhythmia Alarm Settings

(b) Enter [ARR ANALYSIS]menu;
(c) Select [ARR ALARM];
(d) Select [ARR TYPE], select [ALL] or separate arrhythmia [ASYSTOLE], [VFIB/VTAC], [R ON T],
[VT> 2], [COUPLET], [PVC], [BIGEMINY], [TRIGEMINY], [Supraventric.Tachy.], [BRADY],
[MISSED BEATS], [NOIS SIGNAL], [SIGNAL WEAK], [ARRHYTHMIA] and [TACHY];
(e) Others:
Upper and lower limit of alarm:
One-time
Name Maximum Minimum
adjustment
PVCs 10 1 1
15.8.3 Setting the Tachycardia Threshold

(c) Select [TACHYCARDIA] and set the tachycardia threshold. The range is 100 to 300 and the default
threshold is 120.
When the measured HR value violates the tachycardia threshold, the monitor will trigger an alarm.
15.8.4 Arrhythmia Relearning
During ECG monitoring, when great changes of patient’s ECG template takes place, the users should start
the arrhythmia relearning process, which can help the monitor learn new ECG template tocorrect arrhythmia
alarm and HR valuesandrestore ST measurement.
15-13
ECG Monitoring
Particular procedures are:

(c) Select [ARR RELEARN].
15.8.5 Arrhythmia Review

(b) Enter [ARR ANALYSIS] menu;
(c) Select[ARR RECALL]to enter the arrhythmia review window, as shown below:
Figure 15-9Arrhythmia review
(d) Adjust the [END TIME];

(e) Click an alarmevent (like * * BIGEMINY) to enter the review window, as shown below;and view the
parameter values and waveform related to such alarm.
Figure 15-10Arrhythmia review

15-14
Chapter 16 RESP Monitoring
16.1 Overview
The monitor measures respiration according to the thoracic impedance values between two electrodes and
display a channel of RESP waveform on the screen.
16.2 RESP Display
RESP RESP measured

waveform value
Alarm limit
Figure 16-1 RESP display
16.3 Placing Electrodes for RESP Measurement
RESP measurement applies the same electrodes and placement methods as that of ECG monitoring. For
example, if the 5-lead ECG cable is applied, the placement method is shown on the figure below (for the
placement methods of the ECG cable of other lead types, please refer to ECG Monitoring):
Figure 16-2 Positions of electrodes of 5-lead ECG cable
16-1
RESP Monitoring
Attention
 Put the green and the red electrodes at opposite angle so as to get the best respiration wave.
You should avoid putting the electrodes over the liver area and the ventricle of the heart in the
line between the respiratory electrodes, which can help to avoid cardiac overlay or artifacts
from the pulsing blood flow. This is particularly important for neonates.
Lateral thoracic expansion
Some patients’ thorax may expand laterally, especially for the neonates. At the right time, two RESP
electrodes shall be placed on the right mid-axillary line and the left lateral thorax where the patient has the
maximum breathing movement to make sure that the breathing waveform is distinct. See the following
figure:
Abdominal respiration
For some patients the chest movement is limited so they primarily conduct a 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.
16.4 RESP Settings
16.4.1 Setting the Gain
Gain is used to adjust the size of RESP waveform. The alternative gains are 0.25, 0.5, 1 and 2.
(a) Select RESP waveform and the [RESP WAVE]menu will be displayed;
(b) Select [GAIN];
16-2
RESP Monitoring
(c) Select [×0.25], [×0.5], [×1] or [×2].
16.4.2 Setting theApneaAlarmTime
(a) Select RESP parameter area and the [RESP SETUP]menu will be displayed;
(b) Select [APNEA ALM]and then select [10S], [15S], [20S], [25S], [30S], [35S], [40S]or [OFF].
 [10S] meansthat if apnea lasts for more than 10s and RESP alarm function is enabled, the
monitor will give an apnea alarm.
 [OFF] means the apnea alarm function is disabled.
16.4.3 Setting the RESP Lead
RESP lead is where the current respiratory waveform comes from. There are RA-LA (I) and RA-LL (II) to
choose.
(a) Select RESP parameter area and he [RESP SETUP]menu will be displayed;
(b) Select [RESP LEAD] and select [RA-LA (I)] or[RA-LL (II)].
16.4.4 Setting the RESP Filter
Enhancing filter is to enhance filtering the interference of heart beat.

(a) Select RESP waveform area and he [RESP WAVE]menu will be displayed;
(b) Select [FILTER] and select [ON] or [OFF] to enable or disable the RESP filter function respectively.
16-3
Chapter 17 SpO2 Monitoring
17.1 Overview
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 SpO2 can also provide pulse rate signal and plethysmography wave (PLETH).
17.1.1 Principle of Measuring SpO2
Pulse oximetry is a measurement of oxygen saturation. It is a continuous, non-invasive way of determining

the hemoglobin oxygenation saturation. It is involved in measuring how much light emitting from the sensor
side passes through the patient’s tissue (such as a finger or ear) and then reaches the other side of the
receiver.
Though the amount of light passing through depends on many factors, most of them are constant. However,
one of the factors is that blood flow in the arteries changes with time, since it is pulsatile. It is possible to
obtain arterial blood oxygen saturation by measuring the amount of light absorbed during the pulse. And
surveying pulse itself can supply a “PLETH” waveform and pulse rate signal.
The main screen can display “SpO2” value and “PLETH” waveform.
Warning
 If there is carbonyl hemoglobin, methemoglobin, or dye dilution chemical present, the SpO2
value will deviate.
17.1.2 Recognition of the type of SpO2 Sensor
The types of SpO2 sensor have been configured when the equipment is delivered from the factory, which is
recognizable by the socket connected to the SpO2 sensor:
 Digital SPO2: SpO2 logo marked on the multi-measurement module.
 Nellcor SPO2: SpO2 logo and NELLCOR logo marked on the multi-measurement module.
 Masimo SPO2: SpO2 logo and MasimoSET logo marked on the multi-measurement module.
The wavelength range and maximum light output power of different transducers are very important
information to clinical doctors, such as, when proceeding photodynamic therapy
 Measurable wavelength of Comen SpO2 module sensor: red light 660nm, infraredlight 905nm.
 Measurable wavelength of Masimo SpO2 module sensor: red light 660nm, infraredlight 940nm.
17-1
SpO2 Monitoring
 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 SpO2 sensor. However, as the internal hardware
has been fixed before delivery from factory, the use of improper SpO2 sensor will lead
to wrong measured values.
17.2 SpO2/PR Display
PR measured
value
SpO2 alarm SpO2 PR alarm

Pleth waveform
limit measured limit
value
Figure 17-1 SpO2 display
Warning
 Check whether the sensor cable is in good condition prior to monitoring. When you
discennect the SpO2 sensor cable from the monitor, the monitor will trigger a technical alarm
and display alarm message “SpO2 NO SENSOR” on the screen.
 If the sensor or its packaging has signs of damage, do not use it and return to the factory.
 Continuous and prolonged monitoring may increase the risk of undesirable changes in skin
characteristics, such as irratation, reddenning, blistering, or even pressure necrosis etc,
especially for the neonates or patients with perfusion disorders and varying or immature
forms of skin. Check thesesor application site every two hours and move the sensor if the
skin quality changes.More frequent checkis required due to different status of individual
patents.
 High oxygen levels will have premature children been in danger of infecting the crystal-like
fibrous tissue disease. Therefore, the SpO2 alarm limit must be set carefully based on
generally accepted clinical practice.
 Do not entangle the cable of the sensor and electrical surgical unit.
 Do not placethe sensor on limbs with an arterial catheter or intravenous tube.
 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.
 A functional tester or SpO2 simulator cannot be used to access the accuracy of a pulse
oximeter probe or a pulse oximeter monitor.
17-2
SpO2 Monitoring
 The pulse oximeter monitor is calibrated to display functional oxygen saturation.
Attention
 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.
 There is a signal indicator in SpO2 parameter area to indicating the pulse signal strength.
 The SpO2 waveform is normalized.
17.4 MonitoringSteps
Warning
 Select the appropriate placement according to the instrument and its supporting
probe, which is fundamentally vital to neonates.
1. Turn on the monitor;
2. Insert the connector of the sensor cable into the SpO2socket.
3. Attach the sensor to the appropriate position on the patient.
Placement of finger adult/pediatric SpO2 sensor:
Figure17-2Placement of finger adult/pediatric SpO2 sensor
Placement of neonate SpO2 sensor:

NeonateSpO2sensor consists of the Y-shaped SpO2sensor and sensor jacket. Insert the LED side of the
Y-shaped sensor in the upper groove of the sensor jacket, and respectively the PD side of the sensor in the
lower (See Figure 17-3), then the neonateSpO2sensor is shown in Figure 17-4.
Y-type SpO2sensor
SpO2sensor jacket
Figure17-3NeonatalSpO2sensor (1)
17-3
SpO2 Monitoring
Figure17-4NeonatalSpO2sensor (2)
Attach the sensor to the neonatal hand or foot as shown below.
Figure17-5Placement of the neonatal SpO2sensor
Attention
 When the accurate positioning between the test site and the sensor fails, it may result
in wrong SpO2readings, 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
 The maximum measuring time of SpO2 sensor on a single measuring site is 2 hours.
 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 motion or other factors.
17.5 Measurement Limitations
During operation, the following factors can affect the accuracy of SpO2 measurement :
 High-frequency radio interference, for instance, interference self-generated from the host system or
from electrical scientific instruments connected to the system.
 During magnetic resonance imaging scanning (MRI), do not use the photoelectric oximeter and
oxygen sensor, since induced currents may cause burning.
 Intravenous dye.
 Patient’s excessive movement.
17-4
SpO2 Monitoring
 External radiation.
 Improper installation of sensor or improper contact position with the object .
 Sensor’s temperature (optimal temperature should be among 28 - 42 ).
 The sensor is placed on the limbs with a blood pressure cuff, arterial catheter, or the pipeline of
body cavity.
 The concentrations of non-functional hemoglobin such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb) etc.
 Extremely low degree of blood-oxygen saturation.
 The measured area has poor circulation.
 Syndromes such as shock, a Extreme low degree of blood-oxygen saturation, .anemia or low
temperature etc and application of vasoconstrictor drugs can reduce blood flow to the level of not
being able to be measured.
 Measurement also depends on both the oxyhemoglobin and reduced hemoglobin’s absorption of
specific wavelengths of light. If any other factors absorb the same wavelength, they will generate
false measurement, lower SpO2 values. These factors are as follows: carbonization of hemoglobin,
methemoglobin, methylene blue , indigo rouge.
 It is recommended to use only the SpO2sensor described in the accessories.
17.6 SpO2Settings
17.6.1 Setting theIntelligent Alarm
1. Select SpO2 parameter area and the [SpO2 SETUP] menu will be dispalyed;
2. Select [SAT SECOND]
3. Select [10], [25], [50], [100]seconds or [Disable];
NOTE: This feature is only available on NELLCOR SpO2.
Intelligent alarm is designed to reduce false alarms, help the doctor grasp more accurate and timely changes
in SpO2. For example, set the intelligent alarm range as 50, the upper limit of NELLCOR SpO2 alarm as
97%, and lower limit as 90%, the measured SpO2 value turns out to be 80% and remains for 3 seconds, then,
it decreases to 78% and remains for 2 seconds, so calculating from the time the alarm limit is exceeded, the
sound-light alarm will initialize instantly only when the SpO2 value is out of the alarm range for 5 seconds.
Meanwhile , the circle beside the SpO2 value returns to origin. Its calculation is as follow:
Minus percentage points x seconds = SatSeconds integer
values of the calculated SatSeconds are shown:
%SpO2 second SatSeconds
(90%-80%) x 3= 30
(90%-78%) x 2= 24
Total SatSeconds = 54
17-5
SpO2 Monitoring
Figure17-6 Example figure
SatSeconds Example:
After about 4.9 seconds, the instrument will report SatSeconds alarm, because 54 is beyond the intelligent
alarm range 50 SatSeconds.
Within a few seconds , saturation will fluctuate a bit, and not be stable. Generally, the patient's SpO2 value
may fluctuate between the upper and lower limits of the alarm, and may re-enter to non-alarm range several
times. In this volatile period, the system will store the positive and negative points of the SpO2, till it reaches
the SatSeconds limit or patient’s SpO2 values returned to and remains in the non-alarmrange.
17.6.2 Setting the Pulse Sound
2. Select [BEEP];
3. Select [ON] and you can get a prompt of pulse sound;
4. Select [OFF] and there is no prompt of pulse sound.
NOTE: This feature is only available onMasimo SpO2.
17.6.3 Setting the Signal IQ
When it is turned on, below the PLETH waveform, there is signal collection indication, which is mainly
reflecting the quality of the signal during the acquisition process. This signal indication disappears as it is
turned off.
2. Select [SIGNAL ON/OFF] and toggle between [ON] and [OFF].
17.6.4 Setting the Average Time
The average time, SpO2 value displayed on the monitor, is the result of averaged data collected during a
period of time. The shorter (or longer) the average time is, the faster (or more slowly) the monitor will
17-6
SpO2 Monitoring
respondto the patient’s SpO2 value changes, but with lower (or higher) measurement accuracy. Please set a
shorter average time for critically ill patients so as to analyze the disease in time.
2. Select [AVG TIME(s)];
3. Select [2-4], [4-6], [8], [10], [12], [14] or [16].
17.6.5 Setting the Quick SpO2
Quick SpO2 enables rapid response to, and display of, fast changes in SpO2 by giving priority to the most
recent data.
 When the [AVG TIME(s)] is set to [2-4] or [4-6], the [FAST SAT] turns to [ON] automatically and the
users can perform the rapid SpO2 measurement.
 When [AVG TIME(s)] is set to [8], [10], [12], [14] or [16], the [FAST SAT] turns to [OFF]
automatically and the users cannot perform the rapid SpO2 measurement.
17.6.6 Setting the Calculation Sensitivity
There are three kinds of calculation sensitivities, including normal, sensitive and APOD. For typical patient
monitoring, use “normal” sensitivity. As for those patients who have moist skin, active exercise, or for other
reasons, the sensor may be dropped off a patient’s body, then use the “sensitive” sensitivity. If the patient has
very low perfusion levels and wants to improve the sensitivity performance, please use the “APOD”
sensitivity.
2. Select [SENSITIVE];
3. Select [Normal], [High] or [APOD].
17.7 SpO2Accuracy Test
The recommended method of determining the SpO2 accuracy of the monitor is to compare its SpO2
readings with the readings of a CO-oximeter.
Warning
 A functional tester or SpO2 simulator cannot be used to access the accuracy of a pulse
oximeter probe or a pulse oximeter monitor.
17-7
SpO2 Monitoring
Attention
 Confirmation about SpO2 measurement accuracy: accuracy of SpO2 has 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 nomotion accuracy verification by compared to the laboratory
joint photoelectric oximeterand 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 motion 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
oximeterand monitor. This difference equals to ± one standard deviation, which contains 68%
of the sample.
17.8 Low Perfusion Accuracy Test
This monitor can measure low perfusion and the recommended method of determining the low perfusion
accuracy of the monitor is to compare its low perfusion readings with the readings of a simulator.
17.9 PR Accuracy Test
The recommended method of determining the PR accuracy of the monitor is to compare its PR readings with
the readings of ECG from the same time.
17.10 Masimo Information
 Masimo Patent
It contains one or more of the following U.S. patents: RE38,492, RE38,476, 6,850, 787, 6,826,419,
6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336,
6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,830,
6,067, 462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272,
5,490,505, 5,482,036, international patents or a item or a number of patents referred to in
the www.masimo.com/patents. Including functions from products of Satshare ® and the U.S. Patent
6,770,028. Other patents are under application.
17-8
SpO2 Monitoring
 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.
17-9
Chapter 18 NIBP Monitoring
18.1 Overview
The non-invasive blood pressure (NIBP) measurement uses oscillation method and is available for adults,
pediatric, neonates, pregnant and pre-eclamptic patient.
In order to understand how the oscillation method works, you can compare it to the auscultatorymethod.
 Auscultatorymethod: doctors listen to the blood pressure through stethoscope and know the systolic
pressure and diastolic pressure. As long as the arterial pressure curve is normal, then mean blood
pressure can be calculated through systolic pressure and diastolic pressure.
 Oscillation method: the monitor cannot hear the blood pressure but only measure the vibration scope
of pressure in cuff. The changes of blood pressure cause the vibration of the cuff and cuff pressure at
the maximum scope is the mean blood pressure. The systolic pressure and diastolic pressure can be
calculated after measuring the mean blood pressure.
Generally speaking, auscultatorymethod measures the systolic pressure and diastolic pressure to calculate the
mean blood pressure. Oscillation method measures mean arterial pressure to calculate systolic pressure and
diastolic pressure.
When perfoming NIBP measurement on a pediatric and neonate, you must ensure that the correct measure
mode is selected. Wrong measure mode could jeopardize patient safety, because high blood pressure of
adults is not suitable forpediatric and neonates.
According to the IEC601-2-30/EN60601-2-30 standard, NIBP measurement can be conducted during
electrosurgical operation and during the discharging period of defibrillator.
18.2 NIBP Display
NIBP measured values are displayed in the parameter area.The following figure is for reference only.The
NIBP display on your monitor might be somewhat different:
1 2 3
4
8
7 6 5
Figure 18-1 NIBP display
18-1
NIBP Monitoring
1 Measure mode: manual, auto, or 2 Diastolic pressure

continuous measurement
3 Pressure unit: mmHg or kPa 4 Mean arterial pressure
5 Time of last measurement 6 Cuff pressure
7 Systolic pressure 8 Alarm limit of systolic pressure
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 bloodflow interference.
 Do not place the cuff over a wound, as this can cause further injury.
 Do not place the cuff on any limb whereintravascular access or therapy, or an arterio-venous
(A-V) shunt is present, as thiscould 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 offunction of simultaneously used
monitoring equipment on the same limb.
 NIBP measurement cannot be performed onthose patients suffering from sickle-cell disease or
skin damage or any anticipated damage.
 For a patient suffering from serious disturbance of blood coagulation, the decision to operate
automatic blood pressure measurement must be made according to the clinical evaluation,
because the friction area between body and sleeves has the risk of hematoma.
18.4 NIBP Measurement
18.4.1 Measurement Steps
1. Conenct the NIBP cuff to the monitor and turn on the monitor.
2. Verify that the cuff is completely deflated.
3. Use a cuff with suitable size on the patient. Be sure that the cuff is not too tightly wrapped around the
limb, otherwise it may cause discoloration or even ischemia to the far end of the limb.
18-2
NIBP Monitoring
Figure 18-2 Cuff 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/neonateresuable cuff:
Patient type Limb Circumference Cuff width Gastube length
Neonate 6 11cm 5cm
Infant 10 19 cm 8 cm
Pediatric 18 26 cm 10.6 cm
2m
Adult 1 25 35 cm 14 cm
Adult2 33 47 cm 17 cm
Leg 46 66 cm 21 cm
Neonate disposable cuff:
Size Limb Circumference Cuff width Gastube length
Neonate 1 3.0 5.5 cm 2.6cm
Neonate 2 4.0 7.6 cm 3.7 cm
Neonate 3 5.6 10.6 cm 4.5 cm 2m
Neonate 4 7.0 12.8 cm 5.3 cm
Neonate 5 8.9 15.0 cm 6.0 cm
18-3
NIBP Monitoring
4. Check if the edges of the cuff are located inside the range marked by < - >. If not, replace the cuff with
a more suitable one.
5. Check that the monitor mode is correct (displayed in the NIBP parameter area). To change the measure
mode, please enter the menu [NIBP SETUP] to change [MEASURE MODE].
6. Press the key on the front panel or click [NIBP START] on-screen key to inflate the NIBP cuff.
Body parts used for pressure-measuring should be in the same horizontal location with patient's heart. If
unable to do so, it is necessary to use the following correction method to modify the measurement results:
 If cuff is above the heart level location, 0.75mmHg (0.10kPa) should be added to the displayed value
for per centimeter gap.
 If cuff is below the heart level location, the displayed value should minus 0.75mmHg (0.10kPa) for
per centimeter gap.
In order to obtain accurate blood pressure measurement for the hypertension patient, the patient position
should be as follows:
a) Comfortably seated
b) Legs uncrossed
c) Feet flat on the floor
d) Back and arm supported
e) Middle of the cuff at the level of the right atrium of the heart
18.4.2 Operation Prompt
(1) Start an auto measurement:

Enter the menu[NIBP SETUP] and select[INTERVAL]to select the time interval for auto measurement,
and then press the key on the front panel or click [NIBP START] on-screen key to inflate the
NIBP cuff and measure the NIBP as per the set time interval.
(2) Start a manual measurement:
 Enter the menu[NIBP SETUP]and set [INTERVAL]to[MANUAL], and then press the key
on the front panel or click [NIBP START] on-screen key to start a manual measurement.
 You can press the key to start a manual measurement after the auto measurement stops. If
you press the key again, the manual measurement will be stopped and auto measurement
resumes.
(3) Start a continuous measurement:
Enter the menu[NIBP SETUP] and select[CONTINUAL] to start a continuous measurement lasting for
5 minutes.
(4) Stop the measurement:
In the measurement process, you can press the key to stop at any time.
18-4
NIBP Monitoring
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 minutes should elapse before the first reading is taken.
 If unexpected readings are obtained, first the operator should use the same method to take
measurement and then check the monitor function.
18.4.3 Measurement Limitations
According to the patient's condition, oscillatory measurement has some restrictions. Such measurements are
looking for regular impulse waves produced by arterial pressure. In case the patients’ condition makes this
kind of detection difficult, measurement values will become unreliable and load time will increase. Users
should be aware that the following conditions will interfere with the measurement method, so that pressure is
not reliable or load time increases. In this case, the patient's condition will make measurement impossible.
(1) Patient Mobility
If patient is moving, shaking or in spasms, measurement will be unreliable or even impossible, as these
may interfere with the detection of the arterial pressure pulse and load time will be extended.
(2) Arrhythmia
If patient has shown arrhythmia caused by irregular heart beats, measurements are unreliable or even
impossible and load time will be extended.
(3) Heart-Lung Machine
If patient is connected to an artificial heart-lung machine, measure cannot be conducted.
(4) Pressure Change
If within a certain time, arterial pulse pressure is being analyzed to get the measurements, when blood
pressure in patients is rapidly changing, measurement will be unreliable or even impossible.
(5) Severe Shock
If a patient is in serious shock or hypothermia, the pressure will be unreliable. The reducing blood
flowing to periphery would cause a decline in arterial pulse.
(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
18-5
NIBP Monitoring
reaching the cuff. The accuracy is lower than the normal one.
18.5 NIBP Settings
18.5.1 Setting the Measure Mode
Measure mode includes adult, pediatric and neonate, which is the same as the patient type.
(a) Select NIBP parameter area and the [NIBP SETUP]menuwill be displayed;
(b) Select [MEASURE MODE] and select[ADU], [PED] or[NEO] ;
18.5.2 Setting the Interval Time
(a) Select NIBP parameter area and the [NIBP SETUP]menuwill be displayed;
(b) Select [INTERVAL];
(c) Select [MANUAL] to conduct a manual measurement;
(d) Select [1MIN], [2MIN], [3MIN], [4MIN], [5MIN], [10MIN], [15MIN], [30MIN], [60MIN], [90MIN],
[120MIN], [180MIN], [240MIN] or [480MIN] for auto measurement;
18.5.3 Setting the Pressure Unit
(a) Select NIBP parameter area and the [NIBP SETUP] menuwill be displayed;
(b) Select [UNIT] and select [mmHg] or [kPa];
18.5.4 Setting the Pre-inflation Value
(a) Select NIBP parameter area and the [NIBP SETUP] menuwill be displayed;
(b) Select [INFLATION] and select the suitable pre-inflation value;
 Neonate: the range of pre-inflation value is 60-120 mmHg, the default value is 100mmHg
 Pediatric: the range of pre-inflation value is 80-200 mmHg, the default value is 120mmHg
 Adult: the range of pre-inflation value is 80-240 mmHg, the default value is 160mmHg;
18.6 NIBP Reset
Select NIBP parameter area and select [RESET]. Reset can restore the inflation value of the blood pressure
pump to the initial setting. If the blood pressure pump is working abnormally, it can be checked by means of
reset and will recover from any anomaly caused by an accidental reason.
18-6
Chapter 19 TEMP Monitoring
19.1 Overview
This monitor has two temperature measurement channels; body temperature can be measured by temperature
probes.The probe should be applied to skin or anus according to the type of the probe you bought. The
recommended minimum measuring time is 1 mimute, or the measured value will not be accurate.
19.2 TEMP Display
Unit
TEMP alarm
limit TEMP measured
value
Warning
 Check whether the temperature probe cable is in good condition prior to monitoring. When
you discennect the temperature probe cable from the monitor, the monitor will trigger a
technical alarm and display alarm message “T1 SENSOR OFF”or “T2 SENSOR OFF”on the
screen.
 Be careful in handling the temperature probe and cable, when not in use, the probe and cable
should be pulled into the loose ring. If the wire is pulled too tight, it will lead to mechanical
damage.
 Calibrate the temperature measuring instrument at least once every two years ( or according to
the required time in the hospital directive rules). Please contact the manufacturer when
calibration is needed.
Attention
 Disposable temperature probe can only be used once.
 During the monitoring process, the temperature measuring instrument will automatically
check itself once per hour. Self-checking will last 2 seconds and will not affect the temperature
monitoring.
19-1
TEMP Monitoring
19.4 Steps of TEMP Measurement
(1) If you are using a disposable temperature probe, first connect the temperature probe to the cable first
and then connect the cable to the TEMP socket on the monitor. For reusable temperature probe, it can
be directly connected to the TEMP socket.
(2) Securely attach the temperature probe onto the patient’s body.
(3) Turnon the monitor.
19.5 Setting the TEMP Unit
(a) Select TEMP parameter area and the [TEMP SETUP]menu will be displayed;
(b) Select [TEMP UNIT];
(c) Select [ ] (Celsius degree) or [ ] (Fahrenheit degree) according to your habit.
19-2
Chapter 20 CO2 Monitoring
20.1 Overview
This chapter just introduces the CO2 measurement mode by sidestream and mainstream CO2 modules, which
is different from the operating mode of CO2 measured in anesthetic gas. Please note their differences.
CO2 measurement modes are divided into sidestream and mainstream.
 For sidestream measurement mode, the respiratory gases inside patient airways are sampled with a
constant sampling flow and analyzed by remote CO2 sensor built in the measurement system.
 For mainstream measurement mode, CO2 sensors are mounted on an airway joint that is directly
inserted into the respiratory system of a patient.
CO2 measurement provides:
 CO2 waveform.
 End-tidal CO2 (EtCO2):CO2 value measured at the end-tidal of respiration.
 Minimum inspiratory CO2 (Ins CO2):The minimum value measured during respiration.
 Airway Respiration Rate (AWRR):respiration rate per minute derived from CO2 waveform.
Figure 20-1 CO2display
20.2 Understanding CO2 Module
CO2 socket
Figure 20-1 CO2 socket on the multi-measurement module
20-1
CO2 Monitoring
Figure 20-2 Connect the CO2 Module (Left: Respironics; Right: Masimo)
Warning
 The bumping and shaking of the CO2 module should be avoided whenever possible.
Attention
 Do not use this monitor in the presence of combustible anesthetic gas.
 This monitor can be operated only by professionals who are well trained and familiar with this
user manual.
20.3 Measuring Principle and Working Process
The CO2 measuring principle is mainly based on the characteristic that CO2 can absorb the infrared
rays with a wavelength of 4. 3um. The measuring method works as follows: CO2 is introduced to a
measuring chamber of which one side is irradiated by infrared rays, and sensors are employed to measure the
attenuation degrees of received infrared rays at the other side of the measuring chamber, and the attenuation
degree is directly proportional to the CO2 concentrations.
The conversion between CO2 partial pressure and CO2 concentration is:
CO2 Partial Pressure (mmHg)= CO2 Concentration (%) Pamp (Ambient Pressure)
For example:5% CO2 = 38mmHg at 760mmHg
5% CO2 = 35mmHg at 700mmHg
CO2 Module:adopting Autorun instruction measurement mode, and the waveform is sampled once every 31
milliseconds.
20.4 Operating Instruction for CO2 Connection
(1) The connection schematic of the mainstream module produced by the RESPIRONICS company is
shown in the figure below:
20-2
CO2 Monitoring
Figure 20-3Mainstream CO2module connection schematic
(2) The connection schematic of the sidestream module produced by the RESPIRONICS company is
Figure 20-4 Sidestream CO2module connection schematic
(3) The connection schematic of the ISA™sidestream analyzer produced by the Masimo company is shown
in the figure below:
Sampling tube
Figure 20-5ISA™ Sidestream Analyzer (ISA CO2) CO2 Connection Schematic
(4) The connection schematic of the IRMA™ mainstream analyzer produced by the Masimo company is
20-3
CO2 Monitoring
Figure 20-6 IRMA™ Mainstream Analyzer (IRMA CO 2) CO2 Connection Schematic
Warning
 Before use, please check airway joints. Do not use when visible damage or breaks are found on
the airway adapter.
 When CO2 modulle is not used, it must be turned off, otherwise the CO2 module will be in
a working condition all the time.
20.5 Measuring Procedure of RESPIRONICS Mainstream and Sidestream
Modules
The RESPIRONICS sidestream analyzer operating procedure is roughly the same as the mainstream
analyzer operating procedure; please refer to the sidestream analyzer operating procedure for the mainstream
analyzer operating procedure.
1. Turn on the monitor and in case of using C30 multi-measuremnet module, turn on it as well.
2. Make connections according to the CO2 module type or Figure 20-4 or Figure 20-5, and connect the
CO2 module interface cable to the CO2socket on the multi-measuremnet module.
3. Select CO2 parameter aea, in the pop-up [CO2 SETUP] menu, set [CO2 ON] to [ON].
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 it is 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.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
CO2 Monitoring
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 [BARO PRE](Barometric Pressure): 405 760mmHg, the default is
760mmHg. When the CO2 value is higher or lower than the normal value, users should choose
appropriate atmospheric pressure based on the local condition, refer to the table above. (the atmospheric
pressure is corresponding to the altitude, so it can only be adjusted via attitude).
8. In the [CO2 SETUP] menu, select [ZERO CAL](Zeroing calibration) and the status message [ZERO IN
PRO]will be displayed in the CO2 parameter area. You can only start measuring CO2 only after zeroing.
20-5
CO2 Monitoring
20.6 Measuring Procedure of Masimo Sidestream and Mainstream
Analyzers
The Masimo sidestream analyzer operating procedure is roughly the same as the mainstream analyzer
operating procedure; please refer to the sidestream analyzer operating procedure for the mainstream analyzer
operating procedure.
20.6.1 Measurement Steps
If you want to set the host monitoring equipment in order to start gas analysis, please execute the following
procedure:
a) Start the monitor and in case of using C30 multi-measuremnet module, turn on it as well.
b) Connect the Nomoline sampling line to the ISA analyzer.
c) Connect the interface cable of the ISA analyzer to the CO2 socket on the multi-measurement module.
d) Access [MAIN MENU] [MONITOR SETUP] [MODULE SETUP] and set [CO2] to [ON].
e) When connect the CO2 module to the monitor, the [CO2 ON] item turns to [ON] automatically. But
please enter [CO2 SETUP] menu and set [CO2 ON] to [ON] manuualy to make sure the CO2
measurement function is activated.
f) Set appropriate [O2 COMPEN](Oxygen Compensation).
a) Connect the outlet of the sample gas to the discharge system, or to make the gas to flow back to the
patient’s circuit.
b) If the LED is green, ISA Analyzer is available.
c) Carry out pre-use check.
d) If there is nothing wrong, start to monitor the CO2 Gas.
20.6.2 Pre-use Check
Before connecting the Nomoline sampling line to the breathing circuit, carry out the following steps:
a) Connect the sampling line to the gas entrance interface (LEGI) of the ISA CO2 module.
b) Check whether the green light of LEGI is steadily on or not (indicating the system is normal).
c) Breathe to the sampling line, check if valid CO2 waveforms and values are displayed on the host
monitoring equipment.
d) Use the fingertip to occlude the sampling line and wait for 10 seconds.
e) Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light.
f) If applicable: perform a tightness check of the patient circuit with the sampling line attached.
Attention
 The end of the gas circuit adapter which connects the gas sampling tube should point upward
so as to prevent the condensing water drops entering the gas sampling tube and blocking it up.
20-6
CO2 Monitoring
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 specifiedwork
temperature.
 Make sure all connections are firm and reliable. Any leakage will result in the inclusion of
ambient air in the patients respiratory gas, which leads to a wrong reading.
20.7 CO2 Settings
20.7.1 Switching on/off CO2Module
After the CO2 module is connected to the monitor, you need to swtich the CO2 module; when CO2
measuring stops, in order to protect the operating life of CO2module, please switch off the CO2 module.
(a) Select CO2 parameter area and the [CO2 SETUP]menu will be displayed;
(b) Select [CO2 ON] and toggle between [ON] and [OFF].
20.7.2 Setting the Pressure Unit
(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed;
(b) Select [UNIT] and select [mmHg] or [kPa];
20.7.3 Setting the Gas Compensation
(b) Select [O2 COMPEN](Oxygen Compensation)and select [HIGH], [MED] or [LOW];
NOTE: This feature isonly available on Masimo CO2.
Gas compensation setting varies with different CO2 modules;
(b) Select [O2 COMPEN](Oxygen Compensation) and set the value;
NOTE: This feature isonly available on RESPIRONICS CO2.
Warning
 Please set the compensation of various gases based on actual circumstances; otherwise the
measured result may seriously deviate from the actual value, which will result in misdiagnosis.
20-7
CO2 Monitoring
20.7.4 Setting the Apnea Alarm Time
(b) Select [APNEA ALM](Apnea Alarm);
(c) Select [10S], [15S], [20S], [25S], [30S], [35S], [40S] or [OFF].
 [10S] means when the time for the patient to have apnea exceeds 10 seconds, and the CO2alarm
function is enabled, the monitor will trigger an alarm;
 [OFF]: means apnea alarm function is disabled.
20.7.5 Setting theAltitude
(b) Select [ALTITUDE (m)];
(c) Set the altitude and[BARO PRE](barometric pressure)displays different atmospheric
pressuresaccording to auto-set data.
20.7.6 Setting theBalance Gas
(a) Select CO2 parameter area and [CO2 SETUP] menu will be displayed
(b) Select [BALAN GAS](balance gas) ;
(c) Select [ROOM AIR], [N2O] or [HELIUM];
20.8 Discharging Waste Gases
When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from polluting the
operating room. Usually the gas outlet should be connected to (via the gas discharging tube connected to the
sample gas outlet of the host equipment) a discharging system (used for discharging collected gases) or the
patient circuit (used for the back flow of collected gases).
Warning
 When perform measurement on the patients who are receiving or have recently received
anesthetics, connect the outlet on the module to a waste gas processing system, anesthesia
machine or ventilator, so as to prevent medical staff from inhaling the anesthetic.
20-8
CO2 Monitoring
20.9 Zeroing of RESPIRONICS Mainstream and Sidestream Module
Please zero before monitoring CO2; zeroing is to eliminate the effect of baseline drifting on the results
during measurement, thus ensuring the correctness of measured results.
Usually, the module will zero itself automatically when necessary. The user can zero the module
manually when the user considers it necessary:Select [CO2] in the parameter area, in the [CO2 SETUP]
menu popping up, select [ZERO CAL] to zero the CO2 module. During zeroing, make sure that the patient
circuit is exposed to the ambient air (21% oxygen and 0% CO2) for approximately 30 seconds; when
thezeroing prompt on the screen ends, it means zeroing is completed.
20.10 Masimo Mainstream and Sidestream Analyzer RelatedInformation
20.10.1ISA Sidestream Gas Analyzer Safety Information
Warning
 The ISA sidestream gas analyzer is designed to be used by authorized or trained medical
personnel.
 Use only Nomoline sampling lines produced by PHASEIN.
 The ISA sidestream gas analyzer shall not be used with inflammable anesthetic agents.
 Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.
 Do not reuse disposable sampling lines.
 Do not lift the ISA/host equipment by the sampling line as it could disconnect from the ISA/host
equipment, causing the the ISA/host equipment to fall on the patient.
 Used disposable sampling lines should be disposed of according to local regulations for
medical waste.
 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
20-9
CO2 Monitoring
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 the manufacturer. 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.
20.10.2IRMA 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
20-10
CO2 Monitoring
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 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.
20.10.3Zeroing
An infrared gas analyzer needs to establish a zero reference level for CO2, N2O and anesthetic gas
measurement.
 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 multigas 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 CO2 parameter area, in the pop-up [CO2 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.
20-11
CO2 Monitoring
20.10.4CO2 Module Indicator Status
Overview of States Indicated by LEGI:

Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check sampling tube
20.10.5Safety SymbolInformation
Safety Signal Word, Color Code

Description
Symbol and Description Text Format
“Warning” refers to a dangerous situation which may

Warning: Supplementary text. cause personal injury or death. A warning symbol
should be in conformity with: ISO 7010-W001.
Operating Instructions Consult operating instructions

ISA operating instructions Consult ISA operating instructions
Catalog number
Serial number
Lot No.:
The equipment shall not be taken into operation after
Used by date [YYYY-MM-DD]
the date accompanying the symbol.
Temperature limitation
Pressure limitation
Humidity limitation
Do not re-use
Waste electronic and electrical Electrical and electronic equipment shall be collected
equipment (WEEE) and recycled in accordance with Directive2002/96/EC
Containing Pb
Applicable to IRMAXL oxygen

sensors
Complies with 93/42/EEC
European Union Medical DeviceDirective when connected to medical
0413 devices approved by PHASEIN AB
“Splash-proof” IP classification indicating level of water protection
Level of protection from water Provide protection for tools and short wire ends
inflow and solid foreign objects (>1mm).
20-12
CO2 Monitoring
indicated by IP classification Provide protection for water spraying towards all

directions.
Warning (U.S.): Federal law restricts this device to
Sold based on prescriptions sale by or on the order of a (licensed healthcare
practitioner).
Recommended storage
Applicable to IRMA XL oxygen sensors
temperature
Below room temperature (23°C), the maximum
surface temperature of the probe is:
Limited temperature rise - IRMA CO2, 41°C/106°F
- IRMA OR 45°C/113°F
- IRMA AX+ 50°C/122°F
Carbon dioxide ISA equipped to measure CO2 only
Multigas (AX+ or OR+) ISA equipped to measure multiple gases
PHASEIN Sigma multi-gas technology is applied in

Sigma multigas technology
the product
Gas inlet
Gas outlet (evac)
Illustrates the connection of Nomoline to patient
Connection to patient circuit
circuit
Connection to ISA Illustrates the connection of Nomoline to ISA
Non-sterile, Latex free This product is a non-sterile device, free fromLatex.
20.10.6Adverse Effects on Performance
(1) The following circumstances can cause known adverse effects on indicated performance:
 Quantitative effects of humidity or condensate.
 Quantitative effects of barametric pressure.
 Interfering gases or vapors.
 Other sources of interference.
(2) Gas measurement unit
Gas concentration is reported in units of volume percent. The concentration is definde as:
The total pressure of gas mixtureis measured by a cuvette pressure sensor in the ISA gas analyzer.
For conversion to other units, the actural atmospheric pressure sent from the ISA sidestream analyzer
may be used, e.g.
CO2 (mmHg) = (CO2concentration) x (atmospheric pressure (kPa) from the ISA) x (750 / 100)
For example: 5.0 vol% CO2 @ 101.3 kPa 0.05 x 101.3 x 750 / 100 = 38 mmHg
20-13
CO2 Monitoring
(3) Effects of Humidity

The partial pressure and volume percentage of CO2, N2O, oxygen or an anesthetic gas depend on the
amount of water vapor in the measured gas. O2 measurement will be calibrated to show 20.8 vol%, at
actual ambient temperature and humidity level, instead of showing actual partial pressure 20.8 vol% O2
corresponds to the actural O2 concentration in room air with 0.7 vol% H2O concentration (at 1013hPa
this equals for example 25°C and 23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g.
all gases measured by the IR-bench) will always show the actual partial pressure at the current humidity
level.
In the alveoli of a patient, the breathing gas is saturated with water vapor at body temperature (BPTS).
When the breathing gas is sampled, and passing the sampling line, the gas temperature will get close to
the ambient temperature before reaching the ISA sidestream gas analyzer. As the Nomoline removed all
condensed water, no water will reach the ISA gas analyzer. The relative humidity of the sampled
gas will be about 95%.
If CO2 valuesat BTPS are required, the following equation can be used:
Where:
Et CO2 = Et CO2 value sent from ISA [vol %]
Pamb = Ambient pressure sent from ISA [kPa]
3.8 = Typical partial pressure of water vapor condensed between the patient circuit and the ISA[kPa]
Et CO2 (BTPS) = Et CO2 gas concentration at BTPS[vol%]
O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O
20.10.7Airway Obstruction
When the gas airway is occluded, on the screen there will be such analarm message as [AIRWAY
OCCLUSION].Under such a circumstance, replace the Nomoline sampling line.
Warning
 Do not use the ISA sidestream gas analyzer with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
20.10.8Consumables
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.
20-14
CO2 Monitoring
20.10.9Maintenance
The user should verify gas readings regularly; If finding any problem, please contact an engineer of the
manufacturer for maintenance.
20.10.10 Patents and Trademarks
(1) Patent Statement

Masimo owns the following patents for relevant products described in this operating instruction manual:
SE519766; SE519779; SE523461; SE524086. Other patents are being applied.
(2) Trademark
Masimo IRMA™, Masimo ISA™, Masimo XTP™, Sigma Multigas Technology™, LEGI™,
Nomoline™, IRMA EZ Integrator™, PHASEIN GasMaster™ and ISA MaintenanceMaster™ are
trademarks ofMasimo.
Tygothane® is a registered trademark of Saint-Gobain Performance Plastics Corporation.
20-15
Appendix I Product Configuration
Mode
Parameter
C20 C29
FHR √ √
Uterine pressure √ √
FM √ √
ECG ▲ √
NIBP ▲ √
RESP ▲ √
Pulse ▲ √
TEMP ▲ √
SPO2 ▲ √
CO2 ▲ √
Fetal arousal ▲ √
Respiration ▲ √
oxygenation figure
Recorder √ √
Double screen ▲ ▲
display
synchronously
Notes
1. “√”means the device of the corresponding type has the function parameter in the
table.
2. “▲”means the device of the corresponding type has an optional function
parameter in the table.
3. “/” means the device of the corresponding type has no function parameter in the
table.
All of the instrument models have the same structure, safety and reliability.
I-1
Appendix II Accessories
Warning
 Only use the accessories specified in this user manual, or the monitor could be damaged.
 To avoid cross infection, do not reuse any disposable accessory.
 Remove the disposable accessories from their sealed package immediately prior to use.
 The disposal of the reusable or disposable accessories shall comply with the local laws and
regulations or the waste disposal rules and regulations of the hospital.
No. PN Model Type Description

ECG cable
1 040-000479-00 98ME01AC458 Clip 3-lead AHA standard
2 040-000480-00 98ME01AC457 Clip 5-lead AHA standard
3 040-000481-00 98ME01AB076 Clip 12-lead AHA standard
4 040-000485-00 98ME01EC681 Clip 3-lead IEC standard
5 040-000486-00 98ME01EC680 Clip 5-lead IEC standard
6 040-000487-00 98ME01EB075 Clip 12-lead IEC standard
Nellcor SpO2 sensor
7 040-000010-00 DS-100A Reusable Adult for finger
Adult for finger
8 040-000087-00 OXIBAND087-00elo Reusable
Neonatal for foot
9 040-000243-00 / Reusable Cable extender
Comen SpO2 sensor
10 040-000646-00 A1418-SA203MV Reusable Adult for finger
11 040-000334-00 A1418-SW203MU Reusable Neonatal for foot
Masimo SpO2 sensor
Adult for finger
13 040-000198-00 M-LNCS INF-3 Disposable
Neonatal for foot
Adult for finger
14 040-000200-00 M-LNCS NEO-3 Disposable
Neonatal for foot
15 040-000201-00 M-LNCS PDTX-3 Disposable Pediatric for finger
16 040-000202-00 M-LNCS ADTX-3 Disposable Adult for finger
Adult for finger
17 040-000232-00 M-LNCS NEO Disposable
Neonatal for foot
18 040-000203-00 M-LNCS DCI Reusable Adult for finger
19 040-000373-00 M-LNCS DCIP Reusable Pediatric for finger
NIBP cuff
20 040-000005-00 M1574A 27-35CM Reusable NIBP cuff, Adult
21 040-000091-00 CM1205 46-66CM Reusable NIBP cuff, Adult thigh
22 040-000120-00 CM1201 10-19CM Reusable NIBP cuff, infant
23 040-000140-00 CM1202 18-26CM Reusable NIBP cuff, Pediatric
24 040-000141-00 CM1200 6-11CM Reusable NIBP cuff, Neonatal
25 040-000142-00 CM1203 25-35CM Reusable NIBP cuff, Adult
Temp probe
II-1
Accessories
26 040-000246-00 TAS03-04 Reusable Adult Surface

27 040-000387-00 TPS03-03 Resuable Neonatal surface
28 040-000385-00 TAE03-03 Reusable General cavity
29 040-000386-00 TPE03-04 Reusable Neonatal cavity
CO2
29 099-000005-00 1015928 CO2 Module
Mainstream
30 099-000006-00 CAT.NO.200101 CO2 Module
31 099-000004-00 1022054 CO2 Module
Sidestream
32 099-000007-00 CAT.NO.800101 CO2 Module
Fetal monitoring probe
39 040-000616-00 CM-FSUS1 Reusable Primary Waterproof FHR probe
40 040-000617-00 CM-FSUS2 Reusable Deputy Waterproof FHR probe
41 040-000618-00 CM-FST Reusable Waterproof TOCO probe
42 040-000619-00 CM-FSM Reusable Waterproof FM probe
43 040-000186-00 CM-FSUS1 Reusable Primary Waterproof FHR probe
44 040-000332-00 CM-FSUS2 Reusable Deputy Waterproof FHR probe
45 040-000185-00 CM-FST Reusable Waterproof TOCO probe
46 040-000184-00 CM-FSM Reusable Waterproof FM probe
47 040-000054-00 CM-FSUS1 Reusable Primary FHR probe
48 040-000335-00 CM-FSUS2 Reusable Deputy FHR probe
49 040-000053-00 CM-FST Reusable TOCO probe
50 040-000052-00 CM-FSM Reusable FM maker
51 040-000195-00 250ML / Ultrasonic coupling agent
52 040-000226-00 HX-1 Reusable Independent fetal wake device
II-2
Appendix III Product Specification
1. Monitor Type
Item Type
Type of protection against Class I with internal power supply.
electric shock
Degree of protection BF applied parts TOCO, FHR, FM, WAKE, NIBP, TEMP, SpO2
against electic shock CF applied parts ECG
Safety standard MDD 93/42/EEC as amended by MDD 2007/47/EC, EN
ISO13485:2012+AC2012, EN ISO14971: 2012,
EN60601-1:2006/A1:2013, EN 60601-1-2:2007/AC:2010, EN 1041: 2008,
EN980:2008, EN ISO 80601-2-56:2009, EN60601-2-27:2006, IEC
60601-2-49 2011, IEC 80601-2-30:2009, EN 1060-1:1995+ A2:2009,
EN60601-1-8:2007/AC:2010, EN ISO10993-1:2009,
EN1060-3:1997+A2:2009, EN ISO 80601-2-61:2011, EN1060-4:2004,
EN62304:2006,EN62366:2008, EN60601-1-6:2010, EN60601-2-37:2008,
EN ISO 10993-5:2009, EN ISO 10993-10:2010, EN ISO 80601-2-55:2011
Ingress protection IPX1
Safety level if there is any The monitor is not allowed to be used if there is any mixture of flammable
mixture of flammable anesthetic gas and air, or mixture of flammable anesthetic gas and oxygen
anesthetic gas and air or or nitrous oxide.
oxygen/nitrous oxide (not
applicable)
Work mode Continuous running
2.Monitor Specifications
(1) Dimension and Weight
Item Specification
Dimension and weight Dimension: 450mm (L) × 312mm (W) × 99.5mm (H)
Weight: 5Kg (not including battery and mini unit)
Fuse Φ5×20mm T1.6A L250V
(2) Environmental Requirements

Item Specification
Work Ambient temperature 5 40
environment Relative humidity ≤93%
Atmospheric pressure 700hPa 1060hPa
Transport and Ambient temperature -20 +60
storage Relative humidity ≤93%
environment Atmospheric pressure 700hPa 1060hPa
Please protect the Monitor against violent impact, vibration and water in transport.
Power supply Rated input voltage 100-240V
Rated frequency 50Hz/60Hz
Rated input power 120VA
III-1
Product Specification
(3) Display Screen

Item Specification
Display 12.1-inch TFT color touch screen
Display capacity Up to 6 channels of waveform
Resolution 800 600
(4) Battery
Item Specification
Battery specification 4400mAh, 14.8V lithium battery
Charge time At least 5 hours from depletion to 90% charge and at least 6 hours from
depletion to 100% charge when the monitor is switched off.
Operatingtime A new and fully charger Test condition
battery
≥7 hours With maximum screen brightness
≥4 hours With the fully charged C30 product connected
and with maximum screen brightness
≥5.4 hours With the C31 product connected and with
maximum screen brightness
(5) Data Storage

Item Specification
Trend data Short trend 1 hour with resolution of 1 second and 5 seconds
Long trend 120 hours with resolution of 1 minute, 5 minutes and 10
minutes
Trend chart and 120hours
trend table
Alarm events 300parameter alarm events and related parameter waveform
Measured NIBP data 2,000 groups
Waveform history Up to 120 minutes, subject to the type and quantity of the saved waveform.
Frozen waveform 240s mother waveform, 60h fetus waveform.
(6) Fetus Monitoring

Item Specification
Work mode Pulse wave
Ultrasound working frequency (1MHz~3MHz) ±10%
Mechanical index(MI)
Thermal index of soft tissure(TIS)
Thermal index of bone(TIB)
P- (peak negative acoustic pressure) <1MPa

Iob(Intensity of output beam) <20mW/cm2
Ispta(spatial peak - temporal average <100mW/cm2
intensity)
FHR measuring range 30bpm~250bpm
III-2
FHR measuring accuracy ±1bpm

FHR alarm range 30bpm~250bpm
FHR alarm error 1bpm
TOCO measuring range 0~100
Non-linear TOCO measuring error ±8%
TOCO alarm range 0~100
TOCO alarm error 1%
Harmful ingress protection of IPX7
transducers
(7) ECG
Item Specification
Lead select 3 leads, 5 leads, 12 leads; auto recognition
Lead mode 12 leads (R, L, F, N, C; or RA, LA, LL, RL, V)-(R, L, F, N, C1, C2, C3, C4,
C5, C6 or RA, LA, LL, RL, V1, V2, V3, V4, V5, V6)
Lead form I, II, III, avR, avL, avF, V- V1, V2, V3, V4, V5, V6
Lead mode 5 leads (R, L, F, N, C or RA, LA, LL, RL, V)
Lead form I, II, III--I, II, III, avR, avL, avF, V
Lead mode 3 leads (R, L, F or RA, LA, LL)
Lead form I, II, III
Sensitivity (Gain) and 2.5mm/mV( 0.25), 5mm/mV( 0.5), 10 mm/mV( 1), 20mm/mV( 2) and
error auto; when applying 300mV DC polarity voltage, the error is 5%.
Notch Monitor and surgical mode: the 50/60Hz notch function is auto activated;
Diagnostic mode: the 50/60Hz notch function can be select to activate or
deactivate manually.
Power frequency interference rejection capability≥20dB
Noise level 25 VP-P.
CMRR 100dB
Overload protection Load 1V, power frequency, differentialmode AC voltage for 10s without
damage (p-v)
Respiration, lead-off, <0.1µA
sensing and active
noise suppression
QRS wave amplitude Amplitude (p-v RTI) 0.5mV~5mV
and interval Width (adult) 70ms~120ms
Width (pediatric/neonate) 40ms~120ms
No response to the signals: a) With amplitude not exceeding 0.15mV
(p-v RTI) (except for pediatric/neonate
mode); or
b) With 10ms width (except for
pediatric/neonate mode) in case of 1mV
amplitude.
Voltage tolerance >100µV (p-v)
Drift tolerance Triangular wave amplitude (p-v RTI) 4mV
QRS wave amplitude (p-v RTI) 0.5mV
III-3
QRS wave width 100ms

QRS wave recurrence frequency 80bpm
HR measurement Adult 15~300bpm
range and accuracy Pediatric/Neonate 15~350bpm
Accuracy 1% or ±1bpm, whichever is the larger
HR Alarm range Adult 15~300bpm
Pediatric/Neonate 15~350bpm
Alarm error 1bpm
Alarm start time for <10s
asystole
Alarm start time for <10s
heart rate too low or
too high
Input dynamic range Input signal amplitude ±5mV
Rate (RTI) 320mV/s
DC offset voltage -300 ~ +300mV
Output signal change ±10%
Failure display (attenuation No declining below 50%
prior to display)
Input impedance 50M
System noise (p-v <30µV
RTI)
Multi-channel <5%
crosstalk
Time reference Time reference Permanent display 25mm/s, 50mm/s
selection and accuracy selection
Non-permanent display 6.25mm/s, 12.5 mm/s, 25
mm/s, 50 mm/s
Accuracy ±10%
Output display Channel width 30mm
Aspect ratio 0.4s/mV
Input signal Total system error ±20% or ±100µV, whichever is the larger
reproduction accuracy Frequency response Sinusoidal input 0.67~40Hz
(attenuation-3dB)
Response to 20ms 0~25Hz attenuation in
(width) triangular wave amplitude of wave peak
Response to 0.3 mV·s Offset (RTI) ≤0.1mV

shock in the shock
range Slope (RTI) ≤0.30mV/s
Electrode weighting ≥±5%

factor
Hysteresis effect of ≤0.5mm
15mm offset
Calibration voltage 1mV , error: ±5%
Common mode <1mV (p-v RTI)
III-4
rejection
Baseline control and Reset time 3s
stability Drift rate within 10s 10µV/s
Baseline drift in 1h ≤500µV
Baseline drift under working temperature ≤50µV/
Pulse inhibition of Amplitude: ±2mV~±700mV; width: 0.1ms~2.0ms (method A).
non-overshoot
pacemaker
Pulse inhibition of Can not inhibit
overshoot pacemaker
Inhibition of Minimum input slew rate: 320mV/s RTI
pacemaker pulse
detector on quick
ECG signals
Display capability of Amplitude: ±2mV~±700mV; width: 0.5ms~2ms; ≥0.2mV
pacing pulse maximum rise time: 100µS; the ECG display when the
pacemaker pulse appears at 100 per minute.
Arrhythmia types Asystole, VFIB/VTAC, R ON T, VT>2, COUPLET, PVC, BIGEMINY,
TRIGEMINY, Supraventricular Tachy, BRADY, MISSED BEATS, NOISY
SIGNAL, ARRHYTHMIA, TACHY
Leakage current <10uA
Electrosurgical HR change by ±10% or less compared to that before interference
interference inhibition
ESU protection Cut mode: 300W; condense mode: 100W; recovery time: ≤10s.
HR Calculation
Tall T-wave rejection 1.0 mV

capability
Heart rateaveraging Meet the requirements of IEC 60601-2-27: Clause 201.7.9.2.9.101 b) 3). The
HR is computed like this: If the last 3 continousRR intervals are greater than
1200ms, the last 4 RR intervals are averaged to compute the HR. Otherwise,
the last 12 RR intervals with the longest interval and shortest interval
excluded are averaged to compute the HR.
Heart ratemeter Meet the requirementsofIEC 60601-2-27: Clause 201.7.9.2.9.101 b) 4), the
accuracy and response HR is displayed as follows after the 20s stable segment:
Figure A1, Ventricular bigeminy: 80±1bpm
to irregular rhythm
Figure A2, Slow alternating ventricular bigeminy: 60±1bpm
Figure A3, Rapid alternating ventricular bigeminy: 120±1bpm
Figure A4, Bidirectional systoles: 90±2bpm
Response time of Meet the requirementsofIEC 60601-2-27: Clause 201.7.9.2.9.101 b) 5): the
heart rate meterto response time to HR change from 80bpm to 120bpm or from 80bpm to
40bpm is less than 10s.
change in heart rate
Time to alarm for Meet the requirementsofIEC 60601-2-27: Clause 201.7.9.2.9.101 b) 6),
tachycardia the waveform:
Figure B1 1 - range: 10s
Figure B1 0.5 - range: 10s
III-5

Figure B2 0.5 - range: 10s
(8) Respiration
Name Specification
Method Thoracic impedance method
Measurement Range Adult 6 120 rpm
range and
Pediatric/neonate 6 150 rpm
accuracy
Accuracy ±1bpm
Alarm range Adult 6rpm 120rpm
and accuracy
Pediatric/ neonate 6rpm 150rpm
Accuracy ±1bpm
Apnea alarm 10s, 15s, 20s, 25s, 30s, 35s, 40s, OFF
time
(9) NIBP
Name Specification
Measuring Oscillation method
method
Measurement Adult Systolic pressure 40mmHg 270mmHg(5.3kPa 36.0kPa)
range and Mean arterial pressure 20mmHg 235mmHg(2.7kPa 31.3kPa)
accuracy Diastolic pressure10mmHg 215mmHg(1.3kPa 28.7kPa)
Pediatric Systolic pressure 40mmHg 200mmHg(5.3kPa 26.7kPa)
Mean arterial pressure
20mmHg 165mmHg(2.7kPa 22.0kPa)
Diastolic pressure10mmHg 150mmHg(1.3kPa 20.0kPa)
Neonate Systolic pressure 40mmHg 135mmHg(5.3kPa 18.0kPa)
Mean arterial pressure
Diastolic pressure10mmHg 100mmHg(1.3kPa 13.3kPa)
Accuracy 3mmHg. For the NIBP value out of the measurement range above,
the monitor will continue to display it with the accuracy not
specified.
Overpressure Adult 300mmHg
protection Pediatric 240mmHg
Neonate 150mmHg
Error ±3mmHg
Static pressure 0mmHg~300mmHg,
measurement
range
Accuracy ±3mmHg
Alarm range and Adult Systolic pressure:

accuracy 40mmHg 270mmHg(5.3kPa 36.0kPa)
III-6
Mean arterial pressure:

Diastolic pressure
Pediatric Systolic pressure:
Diastolic pressure
Neonate Systolic pressure:
Diastolic pressure
Accuracy ±0.1kPa or ±1mmHg , whichever is the larger.
Measuremode Manual, auto, continuous
Time interval available for 1min, 2min, 2.5min, 3min, 4min, 5min, 10min,
auto measure mode 15min, 30min, 60min, 90min, 120min, 180min,
240min, 480min
Continuous 5min
(10) SpO2
Item Specification
Display resolution 1%
Measurement a) ComenSpO2 module:
range and accuracy Measurement range: 0%~100%;
Accuracy: ±2% (measured without motion in adult/pediatric mode) or ±3%
(measured without motion in neonate mode) within the measurement range
of 70%~100%.
b) MasimoSpO2 module:
Measurement range: 1%~100%;
Accuracy: ±2% (measured without motion in adult/pediatric mode), ±3%
(measured with motion in adult/pediatric mode) or ±3% (measured without
motion in neonate mode) within the measurement range of 70%~100%.
c) NellcorSpO2 module:
Measurement range: 0%~100%;
Accuracy: ±2% (measured without motion in adult/pediatric mode) or ±3%
(measured without motion in neonate mode) within the measurement range
of 70%~100%.
d) The accuracy is not specified within0%~69%.
Alarm range and ComenSpO2 module: 0 100 ;
accuracy Masimo SpO2 module: 0 100 ;
III-7
NellcorSpO2 module: 20 100

Accuracy: ±1%
Data update period 2 seconds
Data and other 8 seconds
signal processing
time
Low perfusion
Conditions Pulse amplitude: > 0.2%
SpO2 Accuracy ±3%
(11) Pulse Rate

Item Specification
Measurement a) Comen SpO2 module
range and accuracy Measuring range: 25bpm~250bpm;
Resolution: 1bpm;
Accuracy: ±1bpm.
b) Masimo SpO2 module
Measurement range: 25bpm~240bpm;
Resolution: 1bpm;
Accuracy: ±3bpm (with motion) or ±5bpm (without motion).
c) Nellcor SpO2 module
Measurement range: 20bpm~300bpm;
Resolution: 1bpm;
Accuracy: ±3bpm within the measurement range of 20bpm 250bpm;
Not specified within the measurement range of 251bom 300bpm.
Alarm range and Alarm range: 20 bpm 300 bpm
accuracy Accuracy: ±1bpm
(12) Body Temperature

Item Specification
Measurement 0 ~50
range
Accuracy ±0.2 (sensor included)
Alarm range 0 50.0 (32 122 )
Alarm resolution 0.1 ( 0.2 )
Display resolution 0.1C
Operating mode Derect mode
Transient response No less than 20 seconds
(13) CO2
Item Specifications
RESPIRONICS Mainstream CO2Measurement 0mmHg 150mmHg, 0% 19.7%, 0kPa
CO2 module range 20kPa(at760mmHg)
CO2Resolution 1 mmHg
III-8
CO2Accuracy a) 0 mmHg 40mmHg: ±2mmHg;

b) 41 mmHg 70mmHg:±5%×reading;
c) 71mmHg 100mmHg: ±8%×reading;
d) 101mmHg 150mmHg: ±10%×reading
RESPIRONICS Sidestream CO2Measurement 0mmHg 150mmHg, 0% 19.7%, 0kPa
CO2 module range 20kPa(at760mmHg)
CO2Resolution 1 mmHg
CO2Accuracy a) 0 mmHg 40mmHg: ±2mmHg;
b) 41 mmHg 70mmHg:±5%×reading;
c) 71mmHg 100mmHg: ±8%×reading;
d) 101mmHg 150mmHg: ±10%×reading
awRR measurement
0rpm 150rpm
range
awRR accuracy ±1rpm
Masimo Mainstream CO2Measurement
0mmHg 190mmHg, 0 25%(at760mmHg)
CO2module range
CO2Resolution 1mmHg
CO2 Accuracy under 0-15 %: ±(0.2 % + reading 2 %)
22±5 ,1013±40hPa 15-25 %: unspecified
CO2 Accuracy under (0.3kPa+reading 4%)
all conditions
awRR measurement
0rpm 150rpm
range
MasimoSidestreamCO2module CO2Measurement
0mmHg 190mmHg, 0 25%(at760mmHg)
range
CO2 Resolution 1mmHg
CO2 Accuracy under 0-15 %: ±(0.2 % + reading 2 %)
22±5 ,1013±40hPa 15-25 %: unspecified
CO2 Accuracy under (0.3kPa+reading 4%)
all conditions
awRR measurement
0rpm 150rpm
range
RESPIRONICS CO2 CO2 0mmHg 150mmHg

modulealarm range awRR 0rpm 150rpm
MasimoCO2module alarm CO2 0mmHg 190mmHg
range awRR 0rpm 150rpm
Alarm error ±0.1kPaor ±1mmHg
(14) Masimo CO2Gas Analyzer

Item Specification
ISA Sidestream analyzer
Measurement method infrared gas mesurement
Apnea alarm time 10s, 15s, 20s, 25s, 30s, 35s, 40s.
General specification
instruction Ultra-compact, low-flow sidestream gas analyzers with integrated pump,
zeroing valve and flow controller.
III-9
Operating temperature ISA CO2 0~50°C 32~122°F

Storage temperature ISA CO2 -40~70°C -40~158°F
Operating humidity ISA CO2 < 4kPa H2O non-condensing 95% RH 30°C
Storage humidity ISA CO2 5-100% RH non-condensing 100% RH 40°C
Operating atmospheric 52.5~120kPa (corresponding to max altitude at 4572m/15000 feet
pressure
Storage barometric pressure 20~120kPa (corresponding to max altitude at11760 m/38600feet)
Power 4.5-5V DC ISA CO2 <1.4W normal operaition <1.8W (peak
@5V DC)
Water treatment Sampling tubes are appatented waterproof tubes
Sampling flow velocity 5010ml/min
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 ISA CO2: Automatic compensation for pressure and temperature;
Manualcompensation for broadening effects on CO2.
Calibration No need for calibration. There is an auto zeroing every time the machine is
started and then auto zeroing every 24 hours after that.
Reheating time ISA CO2 < 10s.
Gas
Measurement range and Accuracy of all measured values is subject to standards of EN ISO
accuracy under standard 21647:2004 and EN 864:1996.
condition CO20-15 vol% ±(0.2 vol% + reading 2 %)
15-25 vol% undesignated
Accuracy specification  0.3 vol%+reading 4%
under all conditions
Up-going time CO2≤ 250ms
System overall response < 3s 2 meters sampling tube
time
Respiratory detection Adaptive threshold, minimum 1 vol% change in CO2 concentration
Respiratory frequency 0-150 times respiration/minute
Interfering gas and vapor effects

Gas or vapour Gas level CO2 AG N2O
ISA CO2 ISA AX+
N2O 4) 60 vol% _ _ _ _
HAL 4) 4 vol% _ _ _ _
ENF, ISO, SEV 4) 5 vol% reading+8% _ _ _
DES 4) 15 vol% reading+12% _ _ _
Xe (Xenon) 4) 80 vol% reading-10% _ _
He (Helium) 4) 50 vol% reading-6% _ _
Metered dose inhaler Metered dose inhaler
propellants propellants
C2H5OH (Ethanol) 4) 0.3 VOI% _ _ _ _
III-10
C3H7OH (Isopropanol) 0.5 VOI% _ _ _ _

4)
CH3COCH3 (Acetone) 4) 1 vol% _ _ _ _
CH4 (Methane) 4) 3 vol% _ _ _ _
CO (Carbon monoxide) 1 vol% _ _ _ _

5)
NO (Nitrogen monoxide) 0.02 vol% _ _ _ _
5)
O2 5) 100 vol% _ _ _ _
Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions” above.
Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect included in the
specification “Accuracy, all conditions” above.
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol%
Helium, the actual measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 4: According to the EN ISO 21647:2004 standard.
Note 5: In addition to the EN ISO 21647:2004 standard.
Item Specification
TM
IRMA maintream gas analyzer
Measurement method infrared gas mesurement
Apnea alarm time 10s, 15s, 20s, 25s, 30s, 35s, 40s.
General specification
instruction Subminiature low-discharge sidestream gas analyzer with one-piecemicropump,
zeroing valve and flow controller.
Operating temperature IRMA CO2 0~40°C 32~104°F
Storage temperature IRMA CO2 -40~75°C -40~167°F
Operating humidity IRMA CO2 10-95% RH, non-condesing
Storage humidity IRMA CO2 5-100% RH, non-condensing
Operating barometric 52.5 ~120kPa (corresponding to the maximum altitude at 4572m/15000 feet)
pressure
Storage barometric 50~120kPa
pressure
Power IRMA CO2 4.5-5V DC maximum power consumption 1.0W
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 Barometric pressure
Mark RESP detected, no RESP detected, replace O2 transducer, check sampling
tubes, accuracy undesignated and wrong transducer
Gas analyzer
ISA transducer 2~9 channels NDIR gas analyzer with measurement range from 4 to 10µm
Calibration No need for calibration. There is an auto zeroing every time the machine is
started and then auto zeroing every 24 hours after that.
Reheating time <20s (usually <10 )
Airway adapter
Adult/child 6ml ineffective volum
Infant 1ml ineffective volum
Gas
III-11
Measurement range and Accuracy of all measured values is subject to standards of EN ISO 21647:2004
accuracy under and EN 864:1996.
standard condition Range Accuracy
CO2 0-15 vol%  0.2vol%+reading 2%
15-25vol% undesignated
Accuracy specification  0.3vol%+reading 4%
under all conditions
Up-going time CO2 90ms N2O, AG 300ms; O2 300ms
System overall <1s
response time
Respiratory detection Adaptive threshold, minimum 1 vol% CO2 change of concentration
Respiratory frequency 0-150 times respiration/minute
Interfering gas and vapor effects

Gas or vapour Gas level CO2 AG N2O
ISA CO2 ISA AX+
N2O 4) 60 vol% _ _ _ _
HAL 4) 4 vol% _ _ _ _
ENF, ISO, SEV 4) 5 vol% reading+8% _ _ _
DES 4) 15 vol% reading+12% _ _ _
Xe (Xenon) 4) 80 vol% reading-10% _ _
He (Helium) 4) 50 vol% reading-6% _ _
Metered dose inhaler Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 VOI% _ _ _ _
C3H7OH (Isopropanol) 0.5 VOI% _ _ _ _
4)
CH3COCH3 (Acetone) 4) 1 vol% _ _ _ _
CH4 (Methane) 4) 3 vol% _ _ _ _
CO (Carbon monoxide) 1 vol% _ _ _ _

5)
NO (Nitrogen monoxide) 0.02 vol% _ _ _ _
5)
O2 5) 100 vol% _ _ _ _
Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions” above.
Note 2: For probes not measuring N2O andO2, the concentrations shall be set from host according to the
instructions in chapter 4.2 (SetN2O / SetO2), please refer to appendix B.(IRMA CO2 measures neither
N2O, nor O2. IRMA AX+ does not measure O2.)
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol%
Helium, the measured CO2 concentration will typically be
(1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 3: According to the EN ISO 21647:2004 standard.
Note 4: In addition to the EN ISO 21647:2004 standard.
Electromagnetic compatibility (EMC)

(1) Electromagnetic compatibility
This section constitutes the guidance and Masimo’s declaration regarding electromagnetic emission for
ISA gas analyxer, IRMA sensor.
The ISA gas analyzer and IRMA sensorare intended for use in the electromagnetic environment specified
III-12
in the table below. Customers and end users of ISAgas analyzers should assure that they are used in such
an environment.
Emissionstest Compliance Electromagnetic environment-guidance
RF emissionsCISPR1 1 Group 1 The ISAsensor 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 establishments
Harmonic emissions N/A including domestic and those directly connected to the
IEC61000-3-2 public low-voltage power supply network that supplies
Voltage fluctuations N/A buildings used for domestic purposes.
flicker
emissionsIEC61000-3-3
(2) Electromagetic immunity
This section constitutes the guidance and Masimo’s declaration regarding electromagnetic emission for
ISA gas analyxer, IRMA sensor.
The ISA gas analyzer and IRMA sensorare intended for use in the electromagnetic environment specified
in the table below. Customers and end users of ISAgas analyzers should assure that they are used in such
an environment.
Immunity test IEC 60601test level Compliance Electromagnetic environment-guidance
level
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or
discharge (ESD) 8 kV air 8 kVair ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast 2 kVfor power N/A AC power quality should be that of a
transient/burst supply lines typical commercial or hospital
IEC 61000-4-4 1 kVfor input/output environment.
lines
Surge 1kV, line(s) to line(s) N/A AC power quality should be that of a
IEC 61000-4-5 2 kV, line(s) to earth typical commercial or hospital
environment.
Voltage dips, <5% UT1(>95%dip N/A The AC power quality should be the same
short interruptions in, UT) 0.5 cycle as in a typical commercial or hospital
and voltage environment. If the user of the ISA sensor
varoations on 40% UT requires continued operation during power
power supply (60%dip in, UT) 5 outages, theISA sensor should be powered
input lines cycles by an uninterruptible power supply or a
IEC 61000-4-11 battery.
70% UT 30%dip in,
UT) 25 cycles
<5% UT (>95%dip
in, UT) 5s
Power frequency 3 A/m 3A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of the ISA sensor, including cables,
than the recommended separation distance
calculated from the equation applicable to
Conducted RF the frequency of the transmitter.
IEC 61000-4-6 Recommended separation
distance:
3 Vrms d= 0.35. p
Radiated RF 150kHz~80MHz 10 Vrms d=0.18 p 80 MHz~800 MHz
III-13
IEC 61000-4-3 d = 0.35 p 800 MHz~ 2.5 GHz

where P is the maximum output power
3 V/m rating of the transmitter in watts (W)
80MHz 2.5GHz 20 V/m according to the transmitter manufacturer
and d is the recommendedseparation
distance in meters (m).
Field strengths from fixed RF transmitters,

as determined by an electromagnetic site
survey, ashould be less than the
compliance level in each frequency
range.bInterference may occur in the
vicinity of equipmentmarked with the
following symbol:
1U T is the AC power before applying test.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
ISAis used exceeds the applicable RF compliance level above, ISAshould be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating ISA.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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 tofrequencyof transmitter[m]
output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d=0.35 p
of transmitter d=0.35 p d=0.18 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
III-14
Appendix IV System Alarm Message
1. Physiological alarm message

Alarm Message Default alarm level Causes Solution
FHR1TOO HIGH High, Medium, Low The measured parameter Check the patient’s
FHR1TOO LOW High, Medium, Low value is higher than the condition and check if
FHR2 TOO HIGH High, Medium, Low upper alarm limit or lower the alarm limit is
FHR2 TOO LOW High, Medium, Low than the lower alarm limit. suitable for the patient
TOCO TOO HIGH High, Medium, Low type.
TOCO TOO LOW High, Medium, Low
HR TOO HIGH High, Medium
HR TOO LOW High, Medium
ST1 TOO HIGH High, Medium
ST1 TOO LOW High, Medium
ST2 TOO HIGH High, Medium
ST2 TOO LOW High, Medium
PVC TOO HIGH High, Medium
PVC TOO LOW High, Medium
SPO2 TOO HIGH High, Medium
SPO2 TOO LOW High, Medium
PR TOO HIGH High, Medium
PR TOO LOW High, Medium
NS TOO HIGH High, Medium
NS TOO LOW High, Medium

ND TOO HIGH High, Medium
ND TOO LOW High, Medium
NM TOO HIGH High, Medium
NM TOO LOW High, Medium
ETCO2 TOO HIGH High, Medium
ETCO2 TOO LOW High, Medium
INSCO2 TOO HIGH High, Medium
INSCO2 TOO LOW High, Medium
AWRR TOO HIGH High, Medium
AWRR TOO LOW High, Medium
Alarm Message Default Selectable Causes Solution

Alarm Alarm Level
Level
RR TOO HIGH Medium High, Medium The measured parameter Check the patient’s
RR TOO LOW Medium High, Medium value is higher than the condition and check if
T1 TOO HIGH Medium High, Medium upper alarm limit or lower the alarm limit is
T1 TOO LOW Medium High, Medium than the lower alarm limit. suitable for the patient
IV-1
System Alarm Message
T2 TOO HIGH Medium High, Medium type.

T2 TOO LOW Medium High, Medium
TD TOO HIGH Medium High, Medium
TD TOO LOW Medium High, Medium
RESP APNEA High High The respiration signal is Check the patient’s
so weak that the monitor condition and check
cannot perform respiration the connection of
analysis. lead wires.
RESP ARTIFACT High High The patient’s heartbeat
has interfered with his
respiration,
ECG LOST High High The ECG signal is
so weak that the monitor
cannot perform ECG
analysis.
CO2APNEA High High The respiration signal is Check the patient’s
cannot perform respiration the connection of CO2
analysis. accessories and airway.
NO PULSE High High The pulse signal is Check the patient’s
cannot perform pulse the connection of SpO2
analysis. sensor.
ASYSTOLE High High Arrhythmia has occurred Check the patient’s
VFIB/VTAC High High to the patient. condition and check
R ON T Medium High, Medium the connection of
VT > 2 Medium High, Medium lead wires and
COUPLET Medium High, Medium electrodes.
PVC Medium High, Medium
BIGEMINY Medium High, Medium
TRIGEMINY Medium High, Medium
Supraventricular Medium High, Medium
tachycardia
TACHY Medium High, Medium
BRADY Medium High, Medium
MISSED BEATS Medium High, Medium
ARRHYTHMIA Medium High, Medium
PNC Medium High, Medium
PNP Medium High, Medium
2. Technical alarm message

There is only one alarm level for a certain alarm condition and the user cannot change it.
Alarm Message Default Causes Solution
Alarm level
ECG LEAD OFF Low ECG electrode has fallen Check the connection of
IV-2
V LEAD OFF Low off from the patient. lead wires and electrodes.
LL LEAD OFF Low
LA LEAD OFF Low
RA LEAD OFF Low
ECG V1 LEAD OFF Low
ECG V2 LEAD OFF Low
ECG V3 LEAD OFF Low
ECG V4 LEAD OFF Low
ECG V5 LEAD OFF Low
ECG V6 LEAD OFF Low
ECG I OVER LOAD Low ECG signal has exceeded Check the connection of
ECG II OVER LOAD Low the measurement range. electrodes and lead wires and
ECG III OVER LOAD Low clean the patient’s skin if
ECG V OVER LOAD Low necessary.
ECG LL OVER LOAD Low
ECG LA OVER LOAD Low
ECG RA OVER LOAD Low
ECG V1 OVER LOAD Low
ECG COMM ERR High There is a problem with the Restart the monitor. If the
SPO2 COMM ERR High communication between problem is still there, please
the module and the contact the serviceman.
TEMP COMM ERR High
monitor.
NIBP COMM ERR High
HR ALM LMT ERR High The alarm limit for a Please contact the serviceman.
PVCS ALM LMT ERR High certain parameter has been
ST ALM LMT ERR High accidentally changed.
RR ALM LMT ERR High
SPO2 ALM LMT ERR High
NS ALM LMT ERR High
NM ALM LMT ERR High
ND ALM LMT ERR High
PR ALM LMT ERR High
TEMP1 ALM LMT ERR High

TEMP2 ALM LMT ERR High
CO2 ALM LMT ERR High
INS ALM LMT ERR High
AWRR ALM LMT ERR High
IV-3
ECG NOISE High There is too much Check if there is any possible
interference signal in ECG source of signal noise from
signal. the area around the cable and
electrodes and check the
patient for great motion.
HR EXCEED High The measured parameter Please contact the serviceman.
PVCs EXCEED High value is not within the
ST EXCEED High specified measurement
ST1 EXCEED High range.
ST2 EXCEED High
ST3 EXCEED High
ST4 EXCEED High
ST5 EXCEED High
ST6 EXCEED High
ST7 EXCEED High
RR EXCEED High
SPO2 EXCEED High
PR EXCEED High
NS EXCEED High
NM EXCEED High
ND EXCEED High
TEMP1 EXCEED High
TEMP2 EXCEED High
TD EXCEED High
SPO2 FINGER OFF Low SpO2 sensor has fallen off Check the connection of SpO2
from the patient’s finger, or sensor, or replace the sensor.
the SpO2 sensor is short
circuit.
SPO2 SENSOR OFF Low SpO2 sensor has not been
connected well, or the
SpO2 sensor is open circuit
or short circuit.
SPO2 NO SENSOR Low The SpO2 sensor has not Check the connection of SpO2
been connected well with sensor.
the monitor.
NELLC Low An error occurred to If the system failed to reset or
ERR,RESETING Nellcor module and the if the error is there after
system is resetting. restarting the monitor, please
contact the serviceman.
UNKNOWN SENSOR Low The SpO2 sensor has Replace the SpO2 sensor.
damaged or the SpO2
sensor not specified is
being used.
DEFECTIVE SENSOR Low Masimo SpO2 sensor is
open circuit.
INTERFERENCE Low There is interference Check if there is any possible
IV-4
signal when measuring source of signal noise around

SpO2 the SpO2 sensor and check the
patient for great motion.
MUCH LIGHT Low There is too much light Move the sensor to a
around SpO2 sensor. place with lower level of
ambient light.
SIGNAL IQ LOW Low The SpO2 signal is too low Check the patient’s condition,
or too weak. or apply the SpO2 sensor to a
suitable measuring site. If the
fault is still there, please
change the SpO2 sensor.
SEARCH PULSE Low The system is searching pulse.
SPO2 INIT ERR High An error occurred to the Restart the monitor. If the
TEMP INIT ERR High module during problem is still there, please
initialization process. contact the serviceman.
NIBP INIT ERR High
SPO2 COMM STOP High The module failed to
TEMP COMM STOP High communicate with the
system.
T1 SENSOR OFF Low TEMP probe has not Check the connection of
T2 SENSOR OFF Low connected well. TEMP probe.
Low power level! Please Medium Low battery Please charge the battery
charge the battery immediately.
CNNT PRS PRB Low The pressure transducer Check the connection of
has not connected. pressure transducer.
CNNT 1ST FHR PRB Low FHR1 transducer has not Check the connection of
connected. FHR1 transducer.
CNNT 2ND FHR PRB Low FHR2 transducer has not Check the connection of
connected. FHR2 transducer.
The first fetal wireless High The battery level of Change the battery of
probes battery is low. FHR1 wireless transducer FHR1 wireless transducer.
is too low.
The second High The battery level of Change the battery of
fetal wireless probes FHR2 wireless transducer FHR2 wireless transducer.
battery is low. is too low.
Uterine High The battery level of Change the battery of
contractions wireless TOCO wireless transducer TOCO wireless transducer.
probes battery is low. is too low.
RECORDER PAPER High No record paper loaded. Load record paper.
LACK
Paper Tray Not Closed High The paper tray has not Close the paper tray well.
closed well.
MONITOR STOP High Timed monitoring stops.
TIMED MONI FINISH High Timed monitoring ends.
3. Prompt Message
Prompt message Causes
IV-5
LOOSE CUFF NIBP cuff is too loose or has not connected with the monitor.
AIR LEAK There is a leak in NIBP airway.
PNEUMATIC LEAK
AIR PRESSURE ERROR An error occurred to the air pressure when measuring NIBP.
WEAK SIGNAL The patient’s pulse is too weak or the cuff is too loose when
measuring NIBP.
RANGE EXCEEDED The NIBP measured value has exceeded the measurement range.
EXCESSIVE MOTION The patient’s arm moves too frequently.
OVER PRESSURE NIBP airway may be occluded.
SIGNAL SATUATED The NIBP signal is saturated due to excess motion or other sources.
NIBP SYSTEM FAILURE An error occurred during NIBP measurement and the monitor
NIBP TIME OUT cannot perform analysis correctly.
MEASURE FAIL
CUFF TYPE ERR Wrong type of NIBP cuff is being used.
NIBP RESET ERR An improper reset occurred during NIBP measurement.
ARR LEARNING Arrhythmia is learning.
ECG Calibrating... ECG is calibrating.
External printing External printer is being used to print.
MANUAL MEASURE Manual NIBP measurement is being performed.
PNEUM TESTING Pneumatic test is being performed.
RESETTING Manual reset is being performed.

CONT MEASURING Continual NIBP measurement is being performed.
PLEASE START Please press NIBP start key to start NIBP measurement.
AUTO MEASURING Auto NIBP measurement is being performed.
ZERO IN PRO CO2 zeroing is in progress.
IV-6
Appendix V Factory Default Settings
1. System Default Settings

Items Factory adult/pediatric/neonate default settings Remarks
Alarm volume 4
Minimun alarm volume 0
Heartbeat volume 2
FHR volume 4
Key volume 4
LCD brightness 5
Case save On
Case save least time 5 minutes
Print alarm history Off
Alarm pause time 2 minutes
Maximun alarm pause
10 minutes
time
Alarm delay time 10 seconds
when CO2 module and
RESP module are
The module is switched on if it is equipped with the equipped with the
Module switch
monitor. monitor simultaneously,
RESP module will be
switched off
Language English
WIFI switch Off
Time end prompt On
Timing care 20 minutes
Grade On
Print report On
Paper type COMEN
Printer select Internal printer
Score select FHR1
Grade criterion Advanced FISCHER

Real-time print speed 3cm/minute
Real-time print time 20 minutes
Review print time 20 minutes
Print ECG waveform On
ECG print speed 25
ECG print time 8 seconds
2. FHR1 Default Settings

Display color Yellow
V-1
FM count Auto/Manual
The FHR sound
channel will be locked if
Sound channel FHR2
there is only on FHR
transducer connected.
Trace offset 0bpm
Sweep 3cm/minute
Cross validation duration Off
Cross validation error 5bpm
3. FHR2 Default Settings

Display color Green
FM count Auto/Manual
Sound channel FHR2 Locked
Trace offset 0bpm
Sweep 3cm/minute
Cross validation duration Off
Cross validation error 5bpm
4. TOCO Default Settings

Display color Purple
FM threshold 50%
TOCO zero 10
AFM color Yellow
5. NIBP Default Settings

Factory default settings
Items Remarks
Adult Pediatric Neonate
Unit mmHg
Display color White
Measure mode Adult Pediatric Neonate
Interval Manual
Initial inflation 160 120 100
6. ECG Default Settings

HR channel Channel 1
HR source ECG
Lead type 5-lead
Notch On
ST segment analysis Off
V-2
ST analysis point ISO:80 ST 108

ARR analysis Off
Gain ×1
Sweep 25.0mm
Filter Diagnosis
Wave type Line
7. RESP Default Settings

Display color Yellow
Apnea alarm 10s
Gain ×1
Sweep 12.5mm
Wave type Line
8. SpO2 Default Settings

Signal indication On
Pulse tone On Only available on
Sat-second Off Masimo SpO2
module
Average time 8S
Sensitivity Normal
Only available on
Intelligent alarm 10 NELLCOR SpO2
module
Sweep 25.0mm
Wave type Line
9. TEMP Default Settings

Display color White
Unit
10. CO2 Default Settings

Display color Red
Unit mmHg
CO2 switch On
O2 compensation Respironics :16; PHASEIN: medium
Balance gas Indoor air Only available on
Altitude 0 Respironics CO2
Barometricpressure 760 module
V-3
Gain ×2
Sweep 6.25mm
Wave type Line
11. Default Alarm Settings

Items Factory default settings
Alarm recording Off
Alarm switch On
Upper limit 210
High level
Lower limit 60
FHR1/FHR2 Upper limit 205
FHR1/FHR2 Medium level
alarm settings Lower limit 70
Upper limit 200
Low level
Lower limit 80
Alarm recording Off
Alarm switch On
Upper limit 100
High level
Lower limit 0
TOCO Upper limit 95
FHR1/FHR2 Medium level
alarm settings Lower limit 5
Upper limit 90
Low level
Lower limit 10
Factory default settings

Items
Adult Pediatric Neonate
Alarm recording On
Alarm switch On
Upper limit 130 170 200
ECG High level
Lower limit 40 60 100
HR alarm
settings Medium Upper limit 125 165 180
level Lower limit 45 70 110
Alarm recording On
Alarm switch On
Upper limit 0.2
ST High level
Lower limit -0.2
ST alarm
settings Medium Upper limit 1.8
level Lower limit -1.8
PVCS alarm recording On
ARR analysis PVCS alarm level Medium
PVCS alarm switch On
V-4
Arrhythmia select ASYSTOLE

Alarm switch On
ARR alarm
settings Alarm level Medium
Alarm recording On
PVCS alarm Upper limit 10

settings Lower limit 0
Alarm recording On
Alarm level Low
Alarm switch On
RESP
Apnea alarm 10s
RESP alarm Upper limit 28 28 100
settings Lower limit 10 10 30
Alarm recording On
Alarm level Medium
Alarm switch On
Upper limit 39.0
T1 alarm settings
TEMP Lower limit 36.0
Upper limit 39.0
T2 alarm settings
Lower limit 36.0
Upper limit 2.0
TD alarm settings
Lower limit 0.0
Alarm recording On
Alarm switch On
High level
SYS alarm Lower limit 70 50 30
NIBP Upper limit 130 110 80
High level
MAP alarm Lower limit 50 30 15
High level
DIA alarm Lower limit 40 30 10
Alarm recording On
Alarm switch On
High level
SpO2 alarm Lower limit 88 88 85
SpO2 settings Medium Upper limit 100 100 100
PR High level
Lower limit 40 65 100
alarm
Medium Upper limit 125 165 190
settings
Alarm recording On
CO2
Alarm switch On
V-5
Apnea alarm 10s

High level
Et alarm Lower limit 5 5 20
AwRR High level
Lower limit 4 4 10
alarm
Medium Upper limit 35 35 110
settings
Upper limit 6 6 6
High level
Ins alarm Lower limit 0 0 0
V-6
Appendix VI EMC
Attention
 C20/C29 meets the requirement of electromagnetic compatibility in IEC60601-1-2.
 The user needs to install and use according to electromagnetism compatibility
information which is attached with it.
 Portable and mobile RF communicationdevices may influence C20/C29 performance, so
C20/C29 should be kept away from them during using.
 Guidance and manufacturer’s declaration stated in the appendix.
Warning
 C20/C29 should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the C20/C29 should be observed to verify normal operation in the
configuration in which it will be used.
 Class A equipment is intended for use in an industrial environment. The C20/C29 may be
potential difficulties in ensuring electromagnetic compatibility in other environments, due to
conducted as well as radiated disturbances.
Guidance and manufacturer’s declaration –electromagnetic emissions

The C20/C29 is intended for use in the electromagnetic environment specified below. The customer or
the user of the C20/C29 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions The C20/C29 uses RF energy only for its internal function.
CISPR 11 Group 1 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions The C20/C29 is suitable for use in all establishments other
Class A
CISPR 11 than domestic and those directly connected to the public
Harmonic emissions low-voltage power supply network that supplies buildings
Class A
IEC 61000-3-2 used for domestic purposes.
Voltage fluctuations /
flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity

The C20/C29 is intended for use in the electromagnetic environment specified below. The customer or the
user of the C20/C29 should assure that it is used in such an environment.
IEC 60601 test Electromagnetic environment –
Immunity test Compliance level
level guidance
Electrostatic ±6 kV contact ± 6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ± 8 kV air ceramic tile. If floors are covered with
synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30 %.
VI-1
EMC
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or
IEC 61000-4-4 hospitalenvironment.
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be that of a
line(s) line(s) typical commercial or
IEC 61000-4-5 ± 2 kV line(s) to ± 2 kV line(s) to hospitalenvironment.
earth earth
Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a
interruptions and (>95 % dip in UT) (>95 % dip in UT) typical commercial or hospital
voltage variations for 0.5 cycle for 0.5 cycle environment. If the user of the
on power supply 40 % UT 40 % UT C20/C29 requires continued operation
input lines (60 % dip in UT) (60 % dip in UT) during power mains interruptions, it is
for 5 cycles for 5 cycles recommended that the C20/C29 be
IEC 61000-4-11 70 % UT 70 % UT powered from an uninterruptible power
(30 % dip in UT) (30 % dip in UT) supply or a battery.
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fieldsshould
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
NOTEUT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity

The C20/C29 is intended for use in the electromagnetic environment specified below.
The customer or the user of the C20/C29 should assure that it is used in such an environment.
Immunity Compliance Electromagnetic
IEC 60601 test level
test level environment – guidance
Portable and mobile RFcommunications
equipment should be used no closer to any part
of the C20/C29, includingcables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Conducted 3Vrms 3Vrms d = 1.2 P
RF 150kHz to 80MHz
IEC
d =1.2 P 80MHz to 800MHz
61000-4-6 3V/m 3V/m
80MHz to 2.5GHz d = 2.3 P 800MHz to 2.5GHz
Radiated RF whereP is the maximum output power rating
IEC of the transmitter in watts (W) according to the
61000-4-3 transmitter manufacturer and d is the
VI-2
EMC
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
shouldbe less than the compliance level in
each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.

NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionand reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the C20/C29 is used exceeds the applicable RF compliance level above, the
C20/C29 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the C20/C29.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended separation distances between

portable and mobile RF communications equipment and the C20/C29
The C20/C29 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the C20/C29 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the C20/C29 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
W
d = 1.2 P d = 1.2 P d =2.3 P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
VI-3
EMC
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VI-4

Monitor Fetal C20 C29

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Monitor Fetal C20 C29

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User manual of C20/C29 Specialized Fetal&Maternal Monitor

After-sales Service Unit

6.3.2 View Patient Case ........................................................................................................... 6-2

9.5 Optimization and Check of Battery Performance....................................................................... 9-2

14.6 Timed Monitoring .................................................................................................................. 14-10

20.8 Discharging Waste Gases ......................................................................................................... 20-8

1.1 Safety Information

(1) Product Symbols

BF applied part with

Battery worke indicator Europeancommunity

The transducers are dust-tight

Alarm pause Alarm reset

TOCO zero Print key

This side up Maximum stacking layer

Fragile Keep dry

2.1 Intended Use

2.4 Appearance Introduction

2.4.1 Front View

Figure 2-1 Front view

TOCO Zero key Press to perform TOCO zeroing.

Print key Press to start printing or stop printing

Ventilation Hole Other sockets

Figure 2-2 Left view

Transducer Bracket Transducer Socket

Before inserting the C30/C31 multi-measurement module, please remove the

How to install the C30/C31 multi-measurement module

USB Connector Power Socket

Figure2-4 Rear view

2.4.5 Bottom View

Fetal Heart Speaker

Figure 2-1 Bottom View

Figure 2-6 Keyboard

No. Symbol Name Description

Lock/Unlock key Lock/unlock the screen.

Main menu key Press it to enter [MAIN MENU].

Input method Press it to switch among such input methods as Englishand

2.5 On-screen Display

Figure2-7 Main screen

1. Network Connection Status Icon

 Click here to directly access [TIMER] menu.

 Click or to show more on-screen keys.

3.1 Unpack and Check

3.2 Connect the AC Power Cord

3.3 Turn on the Monitor

3.4 Connect the Sensors

4.1 Safety Instruction

4.2 Enviroment Requirements

The following guidance should be followed to ensurethe safety of electrical installations.

4.3 Grounding protection

4.4 Equipotential Grounding

5.1 Using the Main Menu

How to access [Main Menu]:

operations and settings.

Figure 5-1 Main menu

5.2 General Settings

5.2.1 Setting the System time

There are two methods of setting the system time:

3. Set the system time according to your local time.

5.2.2 Changing System Language

1. Access [MAIN MENU] [MAINTAIN] and enter the password;

5.2.3 Adjusting Alarm Volume

5.2.4 AdjustingHeartbeat Volume

1. Access [MAIN MENU] [SELECTION] [BEAT VOL];