Manual for Maternal / Fetal Integrated Monitor

Copyright
Shenzhen Hwatime Biological Medical Electronics Co., Ltd. ( hereinafter referred to as “HBME” “)
The version number of this manual is subject to update due to change in software or technical
specifications at any time, without notice. The version information for this manual is as follows:
Version: 1.1
Date of issuance: Oct. 2014
ΘHBME all rights reserved.

Product Information
Product Name: Maternal / fetal integrated monitor
Goods Name: Maternal-fetal multi-parameter monitor
Applied product models: T10, T12
Product Registration No.: YSYJX (Z) No.2013 2210962
Registration Standard No.: YZB /Y 0212-2013

Scope of Application
The monitor for medical institutions is used to monitor fetal heart rate, fetal movement and uterine
contraction pressure, as well as to monitor pregnant woman's heart rate, body temperature, and
noninvasive blood pressure and pulse rate parameters.

Main Structure
A monitor comprises of host machine and outsourced accessories. The outsourced accessories include:
triad probe (ultrasound probe, uterine contraction pressure probe, and fetal movement marker), ECG
lead wire, body temperature probe, noninvasive blood pressure cuff, pulse blood oxygen saturation
probe (only for measuring the pulse rate) and power cord.

Statement
Shenzhen Hwatime Biological Medical Electronics Co., Ltd. (“HBME “) owns copyright to the
non-published manual, and has right to treat it as confidential data. This manual is only used for
reference to operate, maintain and repair HBME’s products. Anyone else has no right to disclose the
contents of this manual to others.
This manual contains proprietary information that is protected by copyright law. All copyright reserved.
No parts of this manual is allowed for photographic reproduction, copying, or being translated into other
languages without the prior written consent of HBME.
HBME provides no guarantee of any kind for this manual, including (but not limited to) the guarantee
responsibility for proposed implicit merchantability and suitability related to a particular purpose.

HBME is not liable for incidental or indirect damages due to errors contained within this document, or
provision or the actual performance or the use of this manual.
 Manual for Maternal / Fetal Integrated Monitor

The company should be considered to be liable for reliability, safety and performance of the instrument
only under the following circumstances:
 Assembly operations, expansion, re-adjustment, performance improvement and maintenance
will be performed by staff or organization authorized by HBME;
 The relevant electrical equipments are in compliance with applicable national standards;
 The instrument is operated by following the instructions in this manual.

The content of this manual may be changed without any notice.

HBME reserves the right to modify the content of this manual without prior notice.
HBME reserves the right to make technical alterations without prior notice.
HBME reserves the right to modify product specifications without prior notice.

Safety, reliability and operating conditions

If the following conditions occur, HBME will be not liable for safety, reliability or operating conditions
of maternal-fetal monitors:
■ Assembly is removed, stretched, re-adjusted;
■ Replace the parts without our permission or service this machine by a non-authorized personnel.
■ Products are not used properly in accordance with the Operating Manual ,or power use does not meet

the conditions or NFPA 70: National Electrical Code or NFPA 99: Health Equipment Standard (when

used outside the United States, the installation of power supply must comply with electrical installation

specifications issued by local government agencies).

Quality Assurance
Manufacturing Processes and Raw Materials Assurances:
HBME guarantees that new instruments except multi-function probe will have no faults in production
process and raw materials within a year and a half from the date of shipment under normal use and
maintenance. The guarantee period of multi-function probe is six months. HBME’s obligation under this
guarantee only include maintenance.

Warranty and Repair Services:

Standard warranty period of the maternal-fetal monitor is two years, the standard warranty period of
primary accessories is six months, and warranty period starts from Date of Installation filled in
Equipment Warranty Card attached to the product. The Equipment Warranty Card is the only evidence
for calculating warranty period. In order to protect your rights, please be sure to ask the staff
installing the machine to return the second copy of Equipment Warranty Card” to HBME within
30 days from the date of machine installation.

Scope of Free Services:

HBME’s obligations under this guarantee do not include freight and other charges. Additionally, HBME
will not be liable for direct, indirect or final damage and delay due to the following cases:
 Manual for Maternal / Fetal Integrated Monitor

Improper use, replacement with a part without the permission of HBME, or repair undertaken by a
non-HBME authorized personnel.

Where any equipment is in compliance with the Company's warranty service rule, it is entitled to
receive free service. HBME will provide the service with charges for products needing repair due to the
following reasons:
 Abnormal use;
 The machinery lacks maintenance or is damaged ;
 Label of HBME’s original serial number or manufacturer logo has been replaced or removed;
 Other manufacturers' products.

Scope of charged services:

(1) Where any equipment is beyond the company’s warranty service rule, the company will implement

the fee-based services;

(2) Even during the warranty period, the product needs repair due to the following reasons :
 Man-made damage;
 Grid voltage exceeds the specified range of devices;
 Irresistible natural disasters.

Returns of Goods
Return Process
Where there is need to return product to HBME, please follow these steps:
 To obtain right of return. Contact Customer Service Department of HBME to tell the product’s
serial number which is marked on the exterior shipping box and the product nameplate. If the
serial number is illegible, returns will not be accepted. Please indicate the instrument number,
serial number, and brief reason for the return.

 Freight: the instruments should be shipped to HBME for maintenance; users have to bear the
shipping costs (including customs fees).

After-sale Service
Company Name: Shenzhen Hwatime Biological Electronics Co., Ltd.
Production Address:
Room 701,7/F, Block A, Bofook Lilang Jewelry Cultural Industry Park, No.33, Bulan Rd., Nanwan Street,
Longgang District, Shenzhen
Tel: 0755-36678888
Fax: 0755-85221277
24 hours customer service hotline: 400 8972 888
Zip Code: 518112
 Manual for Maternal / Fetal Integrated Monitor

Preface

Description
This manual details the performance, operation method and other safety information of
maternal-fetal multi-parameter monitors. Before using this product, please read carefully and
understand the content of this manual to ensure proper use of this product and safety of the patient
and operator.
This is also the best beginning for a new user to start using the monitor.
Both Manual and Operating Manual as described in this specification refer to this manual.
Please keep this manual well after reading so that you can access it at any time when needed.

Applicable Targets
This manual is applicable for clinical care professionals to read who desire to learn all kinds of
measuring or operations. The reader should have work experience and required knowledge in terms
of medical procedures, practical experience and terminology related to patients care.

Illustration
All illustrations in this manual are only for reference. The actual display which you will see on the
product may not be entirely consistent with settings or data in the illustrations.
Manual for Maternal / Fetal Integrated Monitor

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 Manual for Maternal / Fetal Integrated Monitor

Concents
Chapter 1 Safety...............................................................................................................................4
1.1 Safety Information.....................................................................................................................................4
1.1.1 Unsuitable Occasions and Warnings.............................................................................................. 4
1.1.2 Precautions..................................................................................................................................... 4
1.1.3 Tips................................................................................................................................................. 5
1.1.4 Danger............................................................................................................................................ 5
1.1.5 Warning.......................................................................................................................................... 5
1.1.6 Caution........................................................................................................................................... 7
1.1.7 Note................................................................................................................................................ 8
1.2 Equipment Symbols.................................................................................................................................. 8
Chapter 2 Product Overview..........................................................................................................10
2.1 Monitor Overview................................................................................................................................... 10
2.2 Product Configuration............................................................................................................................. 11
2.3 Description of Front Panel of the Monitor..............................................................................................13
2.4 Monitor Interface Display....................................................................................................................... 15
2.5 Description of Left Panel........................................................................................................................ 18
2.6 Description of Right Panel...................................................................................................................... 18
2.7 Description of Rear Panel.................................................................................................................... 18
Chapter 3 System Menu.................................................................................................................19
3.1 Date Setting............................................................................................................................................. 19
3.2 System Setting.........................................................................................................................................19
3.3 Print Setting............................................................................................................................................. 20
3.4 Fetal Parameters Alarm........................................................................................................................... 21
3.5 Color Setting............................................................................................................................................22
3.6 Maintenance Setting................................................................................................................................ 22
3.7 Fetal Parameters...................................................................................................................................... 23
3.8 Information of Pregnant Woman.............................................................................................................24
3.9 Blood Pressure Parameters......................................................................................................................25
3.10 ECG & Temperature..............................................................................................................................26
3.11 Scoring Setting...................................................................................................................................... 27
Chapter 4 Installation of Monitor.................................................................................................. 28
4.1 Unpacking and Checking........................................................................................................................ 28
4.2 Electrical Connection.............................................................................................................................. 28
4.3 Power on..................................................................................................................................................28
4.4 Check of the Printer.................................................................................................................................28
4.5 Connection of Sensors.............................................................................................................................29
Chapter 5 Patient Safety................................................................................................................ 30
Chapter 6 Maintenance of Maternal/fetal Monitor........................................................................ 32
6.1 Handling.................................................................................................................................................. 32
6.2 Maintenance & Check.............................................................................................................................32
6.3 Maintenance & Cleaning.........................................................................................................................32
6.4 Disinfection............................................................................................................................................. 33

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6.5 Coupling Agents...................................................................................................................................... 33

6.6 Cleaning of Printhead..............................................................................................................................33
6.7 Ordering Information.............................................................................................................................. 33
Chapter 7 Alarm.............................................................................................................................35
7.1 Overview................................................................................................................................................. 35
7.2 Alarm Properties......................................................................................................................................35
7.2.1 Alarm Type................................................................................................................................... 35
7.2.1.1 Physiological Alarm.......................................................................................................... 35
7.2.1.2 Technical Alarm................................................................................................................ 36
7.2.2 Alarm Mute / Reset...................................................................................................................... 36
7.2.3 Alarm Level..................................................................................................................................36
7.2.4 Alarm Pause..................................................................................................................................36
7.2.5 Sounds and Lights Characteristics for the Alarms at Different Levels....................................... 36
7.2.6 Alarm Method.............................................................................................................................. 37
Chapter 8 Printer............................................................................................................................38
8.1 Installation of Printing Paper.................................................................................................................. 38
8.2 Print Setting............................................................................................................................................. 38
8.3 Print......................................................................................................................................................... 39
8.4 Cleaning of Printhead..............................................................................................................................39
Chapter 9 Monitoring of Fetal Heart Rate..................................................................................... 41
9.1 Brief Introduction.................................................................................................................................... 41
9.2 FHR Setting............................................................................................................................................. 42
9.3 Monitoring of Fetal Heart Rate (FHR)................................................................................................... 42
9.3.1 Methods and Procedures for FHR Signal Acquisition.................................................................42
9.3.2 Monitoring of Single Fetus.......................................................................................................... 43
9.3.3 Monitoring of Twins.....................................................................................................................44
9.4 Common Symptoms Analysis of Fetal Monitoring................................................................................ 44
9.5 Cleaning & Maintenance.........................................................................................................................45
9.5.1 Cleaning of the Probe Cable........................................................................................................ 45
9.5.2 Sterilization of Cable....................................................................................................................46
9.5.3 Processing Cables to Prevent Cross-contamination.....................................................................46
10.1 Brief Introduction.................................................................................................................................. 47
10.2 Uterine Contractions Setting................................................................................................................. 48
10.3 Monitoring of Uterine Contraction Pressure.........................................................................................48
Chapter 11 Monitoring of Fetal Movement and Awakening of Fetus........................................... 49
11.1 Brief Introduction.................................................................................................................................. 49
11.2 Monitoring of Fetal Movement.............................................................................................................49
11.3 Awakening of Fetus.............................................................................................................................. 50
11.3.1 Awakening Device of Fetus........................................................................................................50
11.3.2 Preparation of Operation............................................................................................................ 51
11.3.3 Awakening of Fetus.................................................................................................................... 52
Chapter 12 NIBP Monitoring.........................................................................................................53
12.1 Brief Introduction.................................................................................................................................. 53

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12.2 NIBP Measurement............................................................................................................................... 53

12.2.1 Measurement Method.................................................................................................................55
12.2.2 Operation Instructions................................................................................................................56
12.3 Cleaning & Maintenance.......................................................................................................................56
Chapter 13 SPO2 Monitoring........................................................................................................ 58
13.1 Brief Introduction.................................................................................................................................. 58
13.2 Blood Oxygen Monitoring.................................................................................................................... 59
13.2.1 Blood Oxygen Probe.................................................................................................................. 59
13.2.2 Monitoring Steps........................................................................................................................ 59
13.3 Precautions............................................................................................................................................ 60
13.4 Factors Affecting Readings................................................................................................................... 60
13.5 Cleaning & Maintenance.......................................................................................................................61
13.5.1 Cleaning of Probe.......................................................................................................................62
13.5.2 Cleaning of Cables..................................................................................................................... 62
13.6 Fault Phenomena and Troubleshooting.................................................................................................62
13.6.1 Absence of Blood Oxygen Value............................................................................................... 62
13.6.2 Intermittent Oxygen Values........................................................................................................63
Chapter 14 ECG Monitoring..........................................................................................................64
14.1 Definition of ECG Monitoring..............................................................................................................64
14.2 Precautions............................................................................................................................................ 64
14.3 Monitoring Steps................................................................................................................................... 64
14.3.1 Preparation..................................................................................................................................64
14.3.2 Installation of ECG Leads..........................................................................................................65
14.3.3 ECG Parameter Setting.............................................................................................................. 66
14.4 Maintenance & Cleaning.......................................................................................................................66
Chapter 15 Temperature Monitoring............................................................................................. 67
15.1 Temperature Monitoring....................................................................................................................... 67
15.2 Maintenance & Cleaning.......................................................................................................................67
Appendix A Fault Finding and Troubleshooting............................................................................68
Appendix B Product Specifications...............................................................................................70
Appendix C Parameters and Alarm............................................................................................... 72
Appendix D Accessories................................................................................................................73

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Chapter 1 Safety
1.1 Safety Information
The instrument is ordinary portable device of Class II internal power supply B, BF, CF hybrid.

is application part of type BF, is application part of type B, is application part of

type CF.
BF-type protection represents that the connection for patients should comply with requirements
of allowed leakage currents and dielectric strength in IEC60601-1.
This section lists basic safety information that users should pay attention to and comply with
when using the monitor. The same, similar safety information or additional safety information
related to specific operation will be depicted in the following chapters.
The waterproof rating for Ultrasound probe is IPX1.

1.1.1 Unsuitable Occasions and Warnings

1. The monitor shouldn’t be used at home for it isn’t a therapy device.
2. If this monitor is not fixed well, it may fall and cause personal injury or equipment damage. In order
to prevent personal injury or damage to equipment, please install the device to a fixed position.
3. When the monitor works, do not use mobile phone or other wireless transmission equipment within
10 meters of radius. The monitor cannot be used in an environment with direct sunlight exposal. Do
not use the monitor with any high-frequency device. The monitor shall not be used at a site with
flammable gases such as anesthetics used, otherwise potential explosion exists.
4. Do not use this machine in underwater inspection process. Do not clean the transducer with liquid,
but a soft cloth which is neutral wet can be used to wipe. In order to avoid injury, anybody else
(except after-sales staff of HBME or authorized technical personnel by HBME) is not allowed to
repair the equipment.
5. Do not change the power cord of the monitor or even connect the three-core power cord with the
two-core socket.
6. Do not touch the patient, this monitor or bed during defibrillation.
7. Do not crash probe surface to avoid damage to the wafer.
8. The ambient temperature for continuous operation of instrument should be within + 5 ° C ~ + 40 ° C.
9. Turn off the power to extend the service life of the instrument after each use.
10. The service life of the battery in this device will not be less than 300 times of charge and discharge.

1.1.2 Precautions
1. Before using, verify that the calibration is correct to ensure that the monitor is working properly.
2. Pay attention to placement of power cable, conduit and cable, to avoid patient suffocation due to
entanglement or bring risk to others.
3. Cooling vent at the monitor’s shell must not be blocked in order to dissipate heat.
4. If the liquid is spilled into the casing of the monitor, please disconnect the power immediately and
contact maintenance personnel.

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1.1.3 Tips
The following symbols indicate some important tips; the user should pay attention to:
Danger
Remind you to be aware of imminent hazard, if not avoided, it may result in death, serious injury or property
damage.

Warning
Remind you to be aware of potential hazards or unsafe operation, if not avoided, it may result in death, serious
injury or property damage.

Caution
Remind you to be aware of how to avoid this series monitors from damage.

Note

The emphasized important consideration, and provided description or explanation to make better use of the
product.

1.1.4 Danger
This product has no information regarding danger rating.

1.1.5 Warning

Warning

 To secure continuous safe use of the monitor, you must comply with the instructions listed. Instructions

outlined in this manual cannot be in lieu of the medical steps which have been performed.

 Never rely solely on the monitor's alarm system when monitoring patients, if the alarm limit is set too

low or alarm sound is turned off, this may cause harm to the patients. The most reliable method is that

health care workers closely monitor and properly use the monitor. Monitor alarm function must be

verified on a regular basis. When several devices are simultaneously used on the same patient, the

leakage current may cause dangerous superposition. It is advised that before several devices are

interconnected each other, firstly, qualified professionals should conduct leakage current test to make

sure the leakage current in the allowable safe range, this means that the patient, the operator and the

surrounding environment will not be harmed. If you still have questions, the user should consult the

manufacturer for correct usage. The operator must confirm that the instrument is in proper working

condition and operating environment before using the instrument to monitor. When using a

high-frequency electric knife, the lead wire and cable for patient should be placed away from the surgery

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to ensure cables away from other devices, thereby reduce the burn risk due to high-frequency

electrosurgical generator in case of the bad neutral connection. Regularly check reusable accessories, the

sensor and cables, etc., and replace them in case of damage or breakage. The unusable accessories shall

be disposed properly as medical waste.

 The monitor is designed to be used only by trained health care professionals in health care institutions.

 In order to reduce the risk, be sure not to open the device. If necessary, the device should be handled by
the after-sales staff of HBME or an authorized technician.

 The monitor may interfere with ultrasound imaging system, reflected by interference signal on the
ultrasound screen. The distance between these two devices should be as far as possible.

 Do not touch signal input /output connectors and patients simultaneously.

 It is very dangerous that electrical contact or connection device is exposed to normal saline or other

liquid or conductive adhesive. Electrical contacts and connections such as cable connectors, power

supply, connector with inserted parameter module, chassis connectors, etc. must be kept clean and dry.

They must be thoroughly dried if contaminated by liquid. If further decontamination is required, please

contact your bio-medical department or HBME

 This is not a therapy device.

 If each hospital or institution responsible for use of this instrument cannot establish a set of satisfactory
maintenance plan, it may result in abnormal instrument failure and even endanger people.

 The waterproof rating of this monitor is Type IPX1. Water seepage is not permitted, structural surface
has no wet stains; drops of water falling vertically cause no harmful effects.

 The monitor is used for monitoring patient clinically, and is only allowed to be used by doctors and

nurses .

 Do not open the housing of the instrument to avoid a possible electric shock hazard. Any monitor repairs
and upgrades must be carried out by the technician of HBME or authorized personnel.

 Do not use the instrument at a site where flammable item such as anesthetic agent is placed, so as to
avoid an explosion.

 Before the use, the user should check whether the instrument and its accessories can work normally and
safely.

 To prevent delays in treatment, please make sufficient alarm settings for each patient. Additionally, user
should ensure that the alarm sounds when an alarm is given.

 Don’t use the monitor at an electromagnetic radiation occasion, for example: places where mobile phones
are used.

 During defibrillation, do not touch the patient, table or equipment.

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 Devices interconnected to the monitor should form equipotential body (effectively connected to
protection ground).

 When the monitor is jointly used with electrical surgical equipment, the user (doctor or nurse) should be
cautious to ensure patient safety.

 The packaging must be disposed in accordance with current waste control practice, and the packaging
should be placed out of the reach of children.

 Do not dispose of batteries in fire, so as not to cause an explosion.

 For instrument components identified to be repaired by the user herein, HBME will conditionally provide
circuit diagrams and explain the calibration method as well as other information upon request of user, so

as to help user to arrange appropriate and qualified technician to repair.

1.1.6 Caution

Caution

 When products and accessories described in this manual is about to exceed service life, they must be

disposed in accordance with the relevant product specification. If you want to learn more information,

please contact the company or its representative organizations.

 When you have questions on the perfection or arrangement of external grounding of the monitor, you

must use its internal battery to operate.

 Keep the instrument clean, and avoid oscillation.

 The instrument is designed as of continuous operation mode, and also is a closed anti-drip device. Take

care to avoid splashing water.

 Do not conduct high-temperature sterilization or use electronic beam or γ radiation to sterilize.

 Electromagnetic interference -ensure that the instrument is used in an environment without interference of

strong electromagnetic sources, such as wireless transmitters or mobile phones.

 Before using, the user must check the device to ensure that there is no obvious damage that may affect

patient safety or instrument performance. Recommended inspection cycle is once a month/ or shorter than

a month. If you find obvious damage, it is recommended to replace the damaged parts before use.

Although the design of prenatal maternal-fetal monitor is secure, and resistant to drop or shock, meeting

the complex needs of the clinical work, the device should be used with care; especially when ultrasound

probe wafers are made of ceramic, they should not be collided or have surface scratches.

 The following safety inspection must be performed by personnel who have been properly trained and

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have a certain knowledge and practical experience. Usually, a test should be conducted every two years or

in accordance with inspection procedures specified by public institutions.

 Check whether a mechanical and functional damage exists on equipment.

 Check whether the safety-related labels are easily recognizable.

 Verify whether the device’s functions are consistent with the description in the manual.

 After the end of the effective life cycle, this device will be returned to the manufacturer for processing in

accordance with local regulations.

 The power cord must be inserted in the socket with three wires. Do not remove the earth wire or use a bad

outlet.

 We suggest that, under premise of meeting the clinical needs, the patient's ultrasound irradiation time

should be as little as possible.

 After use, do not wind the cable on the probe to prevent breakage.

1.1.7 Note

Note

 This instrument must not be used at home.

 The device should be installed at a position where you can easily observe, operate and maintain.

 Keep this operating manual near the device, so that you can timely access.

 Though this operating manual describes this series of products in accordance with the most complete

configuration, the product which you have purchased may not have certain configurations or functions.

 If this instrument is splashed or has water condensation, stop the operation.

 Water-based coupling agents are recommended. Since oil-based coupling agents may damage the surface

of the probe, they should be prohibited.

 Steam sterilization cannot be used for the whole machine and other parts such as the probe.

 Do not turn off speaker volume during the monitoring. Monitoring fetal heart sound is very important.

 FHR accuracy controlled by the device cannot be adjusted by the user. If the fetal heart rate results cannot

be trusted, please use other methods such as using a stethoscope to verify, or contact your local agent or

the manufacturer for assistance.

1.2 Equipment Symbols

Interpretation of graphs, symbols, abbreviations used in label of medical device
Beware; see random data (this manual).

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Power on / off.

Alternating current power（AC）

The application components belong to CF type. It has application part of F-type

isolation (floating) with anti-defibrillation function.

The application components belong to CF type, and have application part of F-type
isolation (floating).

The application components belong to BF type, and have application part of F-type
isolation (floating) with anti-defibrillation function.

The application components belong to BF type, and have application part of F-type
isolation (floating)..
This mark shows that the application components belong to B-type.

Equipotential ground terminal.

USB interface

Network Interface

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Chapter 2 Product Overview

■ To comprehensively understand the monitor, please read the Monitor Overview

■ To get introduction to a variety of information displayed on the screen, please read the Screen

Presentation

■To master the methods of operation, please read Key Functions and Basic Operation for the Monitor

■To understand the positions of various interfaces, please read External Interface of the Monitor.

2.1 Monitor Overview

Thank you for purchasing the maternal/ fetal integrated monitor (hereinafter referred to as maternal-fetal

monitor in this manual). This product is a new and well-designed monitor, which brings great convenience to

the medical personnel and pregnant women. It also makes daily care work easier, highly efficient, and less

costly for its easy operation.

This maternal/fetal monitor is suitable for external monitoring. It has a triad probe (including the ultrasound

probe, uterine contraction probe and an event marker for a pregnant woman), a temperature sensor, a blood

oxygen sensor and a blood pressure cuff.

Its performance is in line with the latest world standards. The design of entire machine is simple, reliable and

easy to use. The main features of this product are as follows:

● colorful large-screen LCD displays curve of monitoring parameters and the current monitoring status

which can be stored and played back.

●long-life thermal array recorder with more than 20 year of MTBF. Real-time monitoring or stored

content can be printed out, and the curve is clear.

●The leading DSP technology in the world truly achieves associated operation and pattern recognition of

a fetal heart rate in real-time manner, so as to ensure that the detection of fetal heart rate is accurate and

reliable.

● High sensitivity, low-dose ultrasound probe, 1MHz pulse operation mode, much higher than China's

national security standards, monitoring fetal more safely.

● Dual event marker ---- a standard event marker for a pregnant woman can also be used as clinical event

marking button for a medical personnel.

● triad probe, reducing inter-wire winding.

● blood oxygen probe can immediately detect pulse blood oxygen saturation and pulse rate for a pregnant

woman.

● noninvasive blood pressure cuff can detect the blood pressure for a pregnant women immediately .

● easy and convenient operation through encoder disk.

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● Multiple alarm functions, including: fetal tachycardia / bradycardia alarm, time-up hint of monitoring,

alarm, lacking-paper alarm of the printer.

Principle of work
Maternal-fetal monitor is used to monitor fetal heart rate through non-invasive Doppler ultrasound. Certain

frequency of ultrasound will be reflected when encountering an obstacle in its propagation. If the object is

stationary, the frequency of reflected wave is the same as frequency of the transmitted wave. Once the object

moves, the reflected frequency will change, and the greater the rate of movement of the object, the greater

change in the frequency, this effect is called Doppler Effect. The ultrasound probe is placed on the maternal

abdomen. Since the fetal heart beat has motion in comparison with ultrasound probe, reflected wave will

generate a frequency offset (frequency offset) when the transmitted wave encounters the heart, thereby

frequency of fetal heartbeat per minute (FHR) can be calculated.

Maternal pulse oxygen saturation or pulse measurement method：After red and infrared light emitted by LED

pass through outer periphery of the body, by detecting changes in light absorptivity due to pulsating artery

blood flow resulting from the pulse wave, and photoelectric detection circuit detects the light absorption before

and after pulsation, the pulse oxygen saturation can be thereby calculated. Thus, if a pregnant woman doesn’t

have pulse or her pulse is too weak, the measurement cannot be performed.

Monitoring of non-invasive blood pressure

The monitor uses oscillation method (Oscillometry) to measure non-invasive blood pressure. The arterial

occlusion is obtained through using pneumatic cuff. After arterial blood flow is blocked, the cuff starts to

blow out and detect systolic pressure, mean pressure and diastolic blood pressure in blood vessel. Its

accuracy is superior to Korotkoff Sound Method (Korotkoff), and such a method is positively correlated

to invasive blood pressure monitoring.

● monitoring each stage of post-pregnancy.

● maternal-fetal monitor is not suitable for : monitoring for delivery in water .

Recommended clinical application

Maternal-fetal monitor is suitable for external monitoring applications.

● apply to monitoring fetal heart rate, uterine pressure and fetal movement for a pregnant women from 36

weeks of the gestational age to delivery process; monitoring and measuring blood pressure, pulse oxygen

saturation and pulse rate for a pregnant woman or common patient in a medical unit.

2.2 Product Configuration

● Host
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● Power cord

● Triad probe (ultrasound probe, uterine contraction pressure probe, fetal movement marker)

● Secondary probe (optional)

● Fetus awakening device (optional)

● Blood oxygen saturation probe for pregnant woman（SpO2）

● Cuff and extension tube for measuring maternal non-invasive blood pressure

● ECG cable

● Temperature probe

Host The host contains liquid crystal display module (LED), printer and electronic circuits (including

microprocessor, signal processing system, audio system, display system and power supply).

Probe Containing ultrasound (U / S) probe and uterine contraction pressure (TOCO) probe and

fetal movement button, which are fixed on abdomen of the pregnant woman with elastic

strap. The pregnant woman holds fetal movement button, and press this button when

feeling fetal movement or uterine contraction.

Fetal / maternal / multi-parameter patient monitors are classified into T10 and T12 models with the following

monitoring functions respectively:

Model T10 T12

Function

Size 10.1’’ 12.1’’

Interface Fetal interface, large-font interface Fetal interface,

six-parameter-interface,

maternal-fetal interface,

large-font interface

Fetal heart rate (FHR) Waveform / value Waveform / value

Uterine contraction pressure Waveform / value Waveform / value

（TOCO）

Fetal movement （AFM/MFM） Waveform （optional）/value Waveform (optional) / value

Pulse rate (MHR) Value Value

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Blood oxygen (SPO2) Waveform / value Waveform / value

Blood Pressure (NIBP) Value Value

Electrocardiogram (ECG) Waveform / value Waveform / value

Temperature (TEMP) Value Value

2.3 Description of Front Panel of the Monitor

1. is the LOGO of Shenzhen Hwatime Biological Medical Electronics Co., Ltd.

2. AC-powered indicator light

This light is green when AC power is supplied and it goes out when AC power supply is not in use.

3. The power switch button

Press this button for about three seconds, then the device starts up; press this button for about 3 seconds then

it shuts down. While in custody status, gently tap the key once, the display interface is refreshed, and generates

one number for the pregnant woman, and the fetal movement counting is cleared simultaneously. If NIBP

function is available, then NIBP measurement data will also be cleared.

4. Battery charge indicator

After switching on the external power supply, the light is green when it works, indicating that the battery is

charging; after charging is completed, the light goes out.

5. Battery-powered lights

The light is green when it works, indicating that the instrument works by using internal battery.

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6. NIBP button

You can start / stop the blood pressure measurement by NIBP button.

7. Freeze

Pressing the button, the system enters a frozen state, central position of the display screen shows "freezing”;

press again to clear the block and to restore real-time scanning display.

Under the frozen state, you can not directly enter the system menu. Only the frozen state is removed,

then you can enter the system menu.

8, 9 ▲ and ▼ In the frozen state, you can rapidly backward / forward to increase / decrease the playback

of the recorded curve by ▼ and ▲ keys, the date and time on the LCD are also starting time for the pregnant

woman record. When entering monitoring interface, the two keys are used to adjust the speaker volume.

10. Print key

When the scan is displayed, press the button once, you can enter real-time print status. Under the frozen state,

pregnant women record currently displayed can be printed out. Press “Print” key once again, the print is

canceled. When the printer is working, the right of the screen dynamically displays “Printing”.

Under monitoring interface, real-time recording may be printed without score table; if you select print

content after entering the score interface, the monitor will automatically print out the score table after

printing is completed.

11. Reset key for Uterine Contractions

Uterine contraction pressure can be restored to the reset value, and symbol simultaneously appears at

waveform area of uterine contractions; when entering the menu operation, press this key to return to

monitoring interface.

12. Knob

Turn the knob left/right to move the cursor to the left or right respectively. Press on the encoder disk to confirm,

then enter the corresponding settings. Under the frozen state, you may turn the knob to view monitoring

records by page turning.

13. Display

Waveform, menu, alarm and physiological measurement parameters are displayed.

14. Monitor Models

T10, T12

15. Alarm indicator

Under normal conditions, the indicator is green. When the indicator is yellow or red, this indicates that the

monitor has a physiological or technical alarm, for example, a parameter measurement result is beyond the

limit.
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Note: Function Description of encoder disk

Rotate the encoder disk till when an item turns blue or enclosed in a blue box under monitoring interface or

menu interface, which means this item has been selected. Press the encoder disk to confirm, then adjustable

parameters appear, and then rotate the encoder disk to select. Finally, press the encoder disk to make a

confirmation, and finally close the menu to return to the monitoring interface.

In addition, under scoring interface, if red icon is displayed, indicating this item has been already selected, you

may press the encoder disk to perform corresponding operation.

2.4 Monitor Interface Display

Monitoring interface is divided into three areas: ① waveform area; ② parameter area; ③ information area, as

shown in the following figure:

① Waveform area

Fetal Interface /Six-parameter Interface: waveforms from up to down are as follows: FHR waveform

(twin appear as two FHR waveforms, interval size between the two waveforms is determined by curve

separating value in the system settings), fetal movement waveform, uterine contraction pressure

waveform.

Maternal-fetal interface: waveforms from up to down are as follows: ECG, blood oxygen waveform.

Automatic fetal movement mark:

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Awakening device mark:

Indicates the monitor has detected that the fetal heart rate exceeds the limit at some point and gives

an alarm.

Indicates the monitor has detected the occurrence of marked clinical event or a pregnant woman has

been marked at some point.

Indicates the system detects the pressure is reset at some point.

② Parameter Area

Parameter area is at the right side of screen:

1) Fetal heart rate (FHR)

Fetal heart beats per minute (unit: times/min bpm)

Fetal heart rate display (beats per minute). When no signal is available or the signal quality is poor, '---' will be

displayed. When it is frozen and played back, this value is insignificant.

This icon ( ) indicates speaker volume in eight grades (including from grade 0 to 7), corresponding to

the system volume from silence to strongest volume. When scans are displayed, the volume can be adjusted by

UP /DOWN button on the panel.

(20) The separation value between FHR 1 and FHR 2 curves.

2) Uterine contraction TOCO

Uterine contraction value display (relative values: from 0 to 100). When frozen, this value is insignificant.

(20) Reset value of uterine contraction (setting may be changed)

3) Fetal movement (FM)

AFM: Automatic fetal movement counting

Press the fetal marker once, the fetal movements will be cumulatively counted. Repeatedly press this key

within 5 seconds, the value will be counted only once. When frozen, this value is insignificant.

MFM: Manual fetal movement counting (event marker is invalid in this mode)

4) Blood oxygen saturation SPO2

Blood oxygen saturation SPO2 (unit: %)

5) Pulse rate / heart rate (PR) Unit: times / min

6) Non-invasive blood pressure (NIBP)

Systolic pressure/ mean pressure / diastolic pressure (S / M / D, Unit: mmHg or KPa)

7) Temperature( TEMP) Unit: Celsius degree ℃ or Fahrenheit ℉

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A user may set up various monitoring parameters in detail, and respective settings menu interface will appear

on the main screen when making specific settings. The specific method will be described in detail in each

parameter monitoring section.

③Information Area

Information area located at the lower end of the screen displays the current status of the monitor and pregnant

women. From left to right, the information area displays power, network, printing, printing speed, pregnant

woman number, alarm volume, alarm information, scores buttons, and date / time markings.

Power marking: When connected to an external power source, the icon ( ) indicates AC power supply;

When the AC power is disconnected, the icon ( ) indicates the battery is in use.

Network marking: When connected to the central station, the icon is ; when it is disconnected to the

central station, the icon is .

Print marking: When you start printing, the icon is and flashes; when printing stops, the icon is

Print speed: the current print speeds of printer include three states: 1cm/min, 2cm/min and 3cm / min.

No. of pregnant woman: at each start-up, the system automatically generates a serial number according to the

date and time, and the serial number can be changed in the monitoring process. The changed serial number is

only effective for the data after change.

Alarm volume marking: indicates the current alarm volume which can be set in the menu. Press

the icon for a shorter time to enter mute alarm state until a new alarm event occurs; Press the icon for

a long time to enter paused alarm state in which pause lasts up to 2min. During alarm pause,

even if an alarm event occurs, no alarm is given.

Alarm information: When an alarm occurs, the display position indicates the cause of the alarm occurrence.

If the parameter limit alarm is set to ？ allowable, then when the alarm occurs, this item displays parameters

alarm information. When the paper runs out, or the door of printer is not closed, or printing malfunction occurs,

the system gives an alarm sound, and displays alarm information of printer, indicating printer is partially in

an abnormal state. When you set monitoring time item (monitoring duration item may be set in the system

parameter interface ), if that item is not zero, representing that monitoring time item has been set; after the

monitoring begins, when the time is over, the system gives an alarm sound and displays monitoring time is up.

Scoring button: Click this button ( ), you can enter the score screen.

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Date/Time: Timely displays date and time of monitoring. When it is frozen, then starting date and time of
monitoring record will be displayed.

2.5 Description of Left Panel

ECG: ECG-cable interface for pregnant woman

NIBP: interface for non-invasive blood pressure

cuff of pregnant woman

TEMP: interface for temperature probe of pregnan

woman

Fig. Left Panel

2.6 Description of Right Panel

FHR1: triad probe interface

FHR2: Secondary probe interface (when monitoring

the twins) (optional)

SpO2: probe interface for blood oxygen saturation of

pregnant women

WAKER: interface of fetus awakening device

(optional accessory)

Fig. 2-6 Right Panel

Fig. Right Panel

2.7 Description of Rear Panel

RS232 Reservation, for extended use

Network Interface

Fig. Rear Panel

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Chapter 3 System Menu

■ Date Setting
■ System Setting
■ Printing Setting
■ Fetal Parameters Alarm
■ Color Setting
■ Maintenance Setting
■ Fetal Parameters
■ Pregnant Information
■ Scoring Setting
This monitor configuration is flexible, and time span for printing, scanning speed of
waveform may be set by user according to his/her need. Under monitoring (curve scan)
interface, rotate encoder disk to the parameters area and press, the main menu shown will
appear, and the following operations may be performed:

Fig. Main Menu

3.1 Date Setting
Year, month, day, hour and minute can be set for the monitor.
3.2 System Setting
Select "System Setting" option in the "Main Menu”, the menu will appear as shown in
following figure:

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Fig. System Setting

Printing duration: means the time used for printing on the condition of real-time monitoring

under monitoring interface, and the longest duration is 60min.

When printing duration is over, the monitor will automatically stop the printing.
0min indicates that the Printing duration function has not been set. This
printing duration setting doesn’t affect the printing duration in scoring
setting.
Interface settings: "fetal interface" & "three parameters in large font" are available in

three-parameter fetal monitor.

Several interfaces, including "fetal interface", "six parameters interface",
"maternal-fetal interface" ,"three parameters in large font", "six parameters in
large font" and "nine parameters in large font" , are available in nine-parameter
maternal-fetal monitor,
Display speed: curve that displays speed adjustment may be adjusted according to grade X1, X2,

X4, X8 repectively.
Language choice: used for language switching
Machine-off: this means automatic shutdown function. “0” indicates that the function is disabled;
other value indicates that, when duration of no signal exceeds this value, the system will
automatically shut down. Machine-off time can be set up to 240min.
Alarm volume: measurement of the alarm volume. Four grades for alarm volume, including 0, 1,
2, 3, are available.
Factory default setting: Click this item to restore the system to its default value.
3.3 Print Setting
Select "Printing Setting" option in the "Main Menu”, the menu will appear as shown in following

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figure:

Fig. Printing Setting

Printing speed: used to adjust printing speed, 1cm / min, 2cm / min, 3cm / min are available.

Printing density: used to adjust printing curve concentration to accommodate different thermal paper. Grade 1,

2, 3, 4 and 5 are available for adjustment.

The following four operations are to ensure that user can print by using different specifications of 152mm

paper:

Position for uterine contraction 0: adjust the printing position for uterine contraction 0

Position for uterine contractions 100: adjust the printing position for uterine contraction 100

FHR 90 Position: Adjust the printing position for 90 of FHR

FHR 210 Position: Adjust the printing position for 210 of FHR

3.4 Fetal Parameters Alarm

Select "Fetal Parameters Alarm” in the "Main Menu”, the menu will appear as shown in
following figure:

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Fig. Fetal Parameters Alarm

Alarm switch: whether alarm is allowed when fetal parameters exceed the limit, such as "fetal heart rate- too

high",” fetal heart rate-too low” etc.

On---allowed, Off---not allowed

Alarm levels: alarm priority, and high, medium and low grades for alarm are available.

Alarm upper limit: upper limit of fetal heart rate alarm has 160, 170, 180 and 190 bpm to choose.

Alarm lower limit: lower limit of fetal heart rate alarm has 90, 100, 110, 120 bpm to choose.

Alarm delay: Trigger time that means time interval from detecting FHR exceeding the limit to the beginning of

alarm, has two options: 15 seconds and 30 seconds, when the alarm setting is ON, an alarm

sound is given when the trigger time is up..

Printing alarm: whether to allow print fault alarm, e.g. "The printer is out of paper", "printer door is not

closed."

On--- allowed, Off---not allowed

3.5 Color Setting

Fig. Color Setting

To set color display for each physiological parameter on the interface.

3.6 Maintenance Setting

Select "Maintenance Settings" item in the "Main Menu", then “Pass word" dialog box will pop
up; input the correct password (0000) in the numeric keypad below, and select “Enter”,
then enter the maintenance setting menu as shown in following figure.

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Fig. Maintenance Settings

Hospital: this item can be edited. Input name of the hospital and shut down to save. User may input

up to 20 characters.

Display Mode: Two options including "monitoring” and "demonstration" are available. If user selects

"demonstration" mode, “DEMO" will be displayed on the curve interface.

FHR range: the display range of FHR curve is 50-210 bpm / 30-240 bpm.

Probe type: the connection types of the probe include “wired” and “wireless”.

Networking: communication modes for networking with the central station include optional TCP / IP

and RS485.

Touch screen calibration: to enter the touch screen calibration mode (it should be used in

combination with touch screen function)

Software Version: software version number, not adjustable.

3.7 Fetal Parameters

Select "fetal parameters" item in the "Main Menu", then "fetal Parameters" dialog box
will pop up, as shown in Figure below

Fig. Fetal Parameters

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Curve separation: When twin mode works, in order to make the FHR 1 and FHR2 curves not coincide, and

to make the FHR 2 curve display several units of points that descend. This unit point is the

curve separating value. There are three options including 0, 20 and 30, in which 0 means

no separation. (Unit: bpm.)

FM intensity curve: FM curve display may be turned on or off at the interface. FM curve is a urine

contraction curve displayed on TOCO area representing dynamic information on fetal

activity. Select "On", FM curve will be displayed; select “Off”, FM curve will not be

displayed.

FM counting methods: "Manual" and "AUTO" modes are optional. If user selects "AUTO", then “AFM” will

appear on fetal movement area which is at the right side of screen;

If user selects "Manual", then “MFM” will appear on fetal movement area which is at the right side of screen.

See the description of fetal movement in Chapter VII for more information on "manual fetal movement" and

"automatic fetal movement" modes.

Threshold of fetal movement counting: Automatic fetal movement threshold is adjustable from 10% to 80%.

Threshold of fetal movement indicates the percentage of fetal activity intensity. When

10% is selected, a slight change in the fetus will be counted as one-time fetal movement;

when 80% is selected, only very strong fetal movement will be counted as one-time

fetal movement. It is advised to select 40% --- 60%. When 'Auto' mode for 'fetal

movement counting’ is selected, then the setting for automatic fetal movement (AFM)

works.

Fetal sound channel: a channel of fetal heart sound is optional.

Reset value of uterine contraction: total five grades of reset value of uterine contraction are optional,

including 0, 5, 10, 15 and 20.

3.8 Information of Pregnant Woman

Select "Information of Pregnant Woman” in the "Main Menu", "Information of Pregnant
Woman" dialog box will pop up, as shown in following figure:

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Fig. Information of Pregnant Woman

No. of pregnant woman: No. of pregnant woman currently monitored, if not set, the system automatically

generates a number of pregnant women according to the date and time.

Name of pregnant woman: Select this item to enter the name input interface, and only digit or English can

be allowed to be input. The input name will not be saved under shutdown status.

Gestational weeks: the number of weeks of pregnancy, ranging from 25 to 44 weeks.

Pregnant days: the number of remaining days after removing the weeks of pregnancy, ranging from 0 to 6

days.

Frequency of pregnancies: the number of pregnancies for a pregnant woman.

Number of bed: Bed No. is set when the monitor is connected to the central station. When selecting

R485 as networking mode, it corresponds to 1-4; when selecting TCP / IP， it corresponds to 1-32.

3.9 Blood Pressure Parameters

Select "Blood pressure parameters" in the "main menu", then "Blood pressure parameters"
dialog box will pop up, as shown in the following figure:

Fig. Blood Pressure Parameters

Measurement mode: Blood pressure measurement modes include the "AUTO" and "MANUAL" mode.

The selected measurement mode can be displayed in value area of blood pressure under monitoring interface.
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Measurement interval: 03, 05, 10, 20, 30, 60, 90, 120, 240 (unit: min). Only when the measurement mode is

"AUTO", the set values for measurement interval are meaningful.

Units: Unit of blood pressure is kPa (kilopascals) or mmHg (millimeters of mercury).

Hydrostatic Testing: Click this item back to the monitoring interface, and display area of blood pressure

indicates: Ongoing Hydrostatic Testing.

Gas Leakage test: Click this item back to the monitoring interface, and display area of blood pressure indicates:

Ongoing Gas Leakage Test. When the test is completed, the prompt disappears. If gas leakage

occurs, “Gas Leakage” will be prompted after the test is completed. User can cancel the test

by clicking 'Blood Pressure Measuring’ key.

Speed of blood oxygen waveform: the interface displays the speed of blood oxygen waveform. Three options

including 6.25mm/s, 12.50mm / s and 25.00mm / s are optional.

3.10 ECG & Temperature

Select "ECG temperature" in the "Main Menu", "ECG temperature" dialog box will pop up, as shown in the

following Fig. ECG temperature:

Fig. ECG Temperature

Lead Type: three- lead and five-lead are optional.

Main Lead: When selecting three leads, three options including Ⅰ, Ⅱ, Ⅲ leads are available;

When selecting five leads, seven options including Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF and Ⅴ leads are

optional.

ECG gain: used to adjust the size of the ECG waveform amplitude, and five choices including 0.25X,

0.5X, 1X, 2X and 4X are available.

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ECG waveform speed: the interface displays the ECG waveform speed, three options including 6.25mm /

s, 12.5mm / s and 25mm / s are available.

Temperature unit: ℃ (Celsius) or ℉ (Fahrenheit) is optional.

3.11 Scoring Setting

Fig. Scoring Setting

Scoring criteria: Fischer or Krebs standard is optional for reference.

Experiment type: four options including NST, CS-NST, OCT and CST experiments are available.

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Chapter 4 Installation of Monitor

4.1 Unpacking and Checking
Carefully take the monitor and accessories out of the box, and save the packaging materials well for

shipping or conservation later. Please count the accessories according to the packing list.

■ Check whether there is any mechanical damage.

■ Check all exposed wires and inserted accessories.

When installed, the monitor should allow at least space with a radius of 2 inches around (5 cm) in order to

ensure air circulation. Vibration, dust, corrosive or explosive gases, extreme temperature or humidity should be

avoided in the environment where the monitor is used.

If you have any question, please contact our sales department or the agent.

4.2 Electrical Connection

Steps for connecting the AC power cord:

■ Make sure the AC power supply meets the following specifications: AC.100-240V, 50/60Hz

■ Use the power supply cord attached to the monitor. Plug the power cord into the power interface of

monitor, and insert the other end of power cord into a grounded three-core socket.

Connect the power cord to a dedicated outlet in a hospital.

If a battery is attached to the monitor, after transportation or storage of the instrument, you must charge

the battery. Thus, if the instrument starts up directly, it may fail to work properly due to insufficient battery

power. After the monitor is connected to AC power, the battery can be charged whether the monitor has been

turned on or not.

4.3 Power on
About 15 seconds after turning on the power switch, the system will enter the main monitoring screen after

successful self-test, then the user can operate.

If you find signs of damage related to the monitor function, or an error message, do not use this monitor for the

patient, and please contact the hospital bio-medical engineer or the company's maintenance engineer. If any

fatal error is found during self-test, the system will sound the alarm.

Check all monitoring functions which can be used to ensure that the monitor is functioning properly.

If the monitor is equipped with a battery, then user must charge the battery after each use to ensure enough

power reserves.

It is allowed to start up again only at least one minute after shutdown of the monitor.

4.4 Check of the Printer

Check whether paper is available at paper outlet of the front of monitor.

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4.5 Connection of Sensors

The required sensors are connected to fetal monitor and monitoring site of patient.

Please see the relevant sections for proper connection method of various sensors and related requirements.

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Chapter 5 Patient Safety

Maternal/fetal monitor is designed to meet international safety requirements for medical electrical equipment
such as IEC60601-1, EN60601-2-27 and EN60601-2-30. This system has anti-defibrillation and surgical
electric knife protection of floating ground input, if the correct electrode is used (see section of ECG) and the
system is placed in accordance with manufacturer's instructions, the screen displays will recover within 10
seconds after defibrillation .

This mark indicates that this application component belongs to IEC 60601-1 Type CF equipment, and designed

to have a function of special anti-electric shock protection (especially in terms of allowable leakage current,

F-type floating ground isolation device is furnished), and is suitable for use during defibrillation.

Warning
Do not touch the patient, bed or equipment during defibrillation.

Environment:
Follow following instructions to ensure the absolute safety of electrical installations. Vibration, dust, corrosive

or explosive gases, extreme temperature and humidity must be reasonably avoided in the environment in which

portable monitoring system is used. When the system is installed in the instrument cabinet, there must be

enough space in front in the monitoring system for easy operation. In the case of cabinet door opening,

sufficient space behind the monitoring system should be available for easy maintenance. Air circulation should

be assured inside the cabinet.

If monitoring system works at an ambient temperature ranging 0 ℃ ~ 40 ℃, it can meet the technical

specifications. When ambient temperature is beyond this range, the accuracy of the instrument may be affected

and even components and circuit will be damaged. At least space with a radius of 2 inches (5 cm) should be

allowed around the instrument to keep air circulation.

Power Requirements
Please see product specifications section.

Grounding of maternal-fetal monitor

In order to protect patients and medical personnel, maternal-fetal monitor enclosure must be grounded.

Therefore, maternal-fetal monitor is equipped with a detachable three-wire cable, when it is inserted into a

compatible three-wire outlet; instrument is connected to ground through the ground wire (protective earth) in

the power cord. If no three-wire socket is available, consult an electrical manager of the hospital.

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Warning
Three-wire cable for this instrument must not be connected to two-wire plug.

The ground wire is connected to equipotential grounding terminal of the instrument. If you do not know

particular instrument combination is dangerous or not just according to instrument specifications, for example,

potential danger due to accumulated leakage currents, the user should consult the relevant manufacturer or

experts in this field to ensure that necessary safety for all instruments involved will not be damaged by the

proposed device combination.

Equipotential grounding
Level 1 protection for instrument has been included in the protective grounding (protective earth) system of

housing through power plug connected to ground. For internal examination of the heart or brain, portable

monitoring systems must be connected to equipotential grounding system separately. One end of the

equipotential grounding wire (potential equalization conductors) is connected to equipotential ground terminal

at the rear panel of the instrument, while the other end is connected to a connector of the equipotential system.

If protective grounding system is damaged,equipotential grounding system can protect the grounding

conductor. Heart (or brain) examination should only be carried out in house for medical purpose equipped with

protective earthing system. Before each use, you must check whether the instrument is in good working

condition. Cables connecting the patient with instruments must be free from electrolyte contamination.

Warning
If the protective ground (protective earth) system is not stable, the internal power supply should be used for the

monitor.

Condensation
During the work, user should ensure that the instrument is free of condensation.

When the instrument is moved from one room to another, condensation may form since the instrument is

exposed to moist air and among different temperatures.

Warning
If the monitor is used at a site where flammable anesthetic is available, there is a risk of explosion.

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Chapter 6 Maintenance of Maternal/fetal

Monitor
6.1 Handling
Although maternal/fetal monitors has firm design to meet the clinical use, please be still careful to use it.

Pay attention to maintenance, especially ultrasound probe wafers that are made of ceramic and must be

protected from falling or collision.

6.2 Maintenance & Check

Before using this monitor, you must check the following:

● To check if there is any mechanical damage.

● To check all exposed wire, inserted portion and accessories.

● To check all instrument functions which may be used for monitoring patient, and ensure that the instrument

is in good working condition.

If any sign indicating damage on the instrument has been found, then the monitor shall not be used to carry out

any monitoring on the patient body. Please contact bio-medical engineer of hospital or maintenance engineer

of the Company.

Complete functional check, including safety checks, must be carried out once by qualified personnel every

6-12 months or after each maintenance.

6.3 Maintenance & Cleaning

Maternal-fetal monitor does not need additional maintenance except cleaning.

Keep outer surface of the instrument clean without dust. Use a dry, soft cloth to clean the outer surface of the

machine casing (including the LCD display). If necessary, only a soft cloth moistened with soap or water can

be used to clean the casing.

Wipe the redundant coupling agent on the probe with a soft cloth. Only soap and water can be used

to clean the probe.

Caution
Prohibit the use of strong solvents such as acetone.

Caution
Prohibit the use of abrasive material (such as steel wool or silver polish)

Caution
Prohibit any liquids into the machine casing.

Prohibit any part of the instrument from liquid immersing.

Caution

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Do not pour the liquid into the instrument when cleaning.

Caution
Do not allow any cleaning solution remain on the surface of the instrument.

Note
Probe surface can be wiped with 70% ethanol or isopropyl alcohol, then be dried by natural air or cleaned with

a neat dry cloth.

6.4 Disinfection
Clean the outer surface of the device and the probe according to the above-mentioned method, then wipe the

probe surface with a 70% ethanol or isopropanol alcohol. Next, wipe the probe surface with a dry and soft

cloth to remove residual liquid substances.

Caution
Do not use low temperature steam or other methods to sterilize the device or the probe.

6.5 Coupling Agents

It is advised to use water-based coupling agent attached to the device. Never use oil-based coupling

agents, and the machine warranty will automatically terminate in case of damage to the probe due to using

oil-based coupling agent.

6.6 Cleaning of Printhead

The time between failures of thermal print head is more than 20 years; this is just guarantee for electrical

aspects. Printing paper and the cleanliness of operating environment have a great impact on the printing effect.

When the printed content is not clear or the partial region is unable to be printed out, the priority work is to

clean the print head, and the methods and steps are as follows:

1. Turn off the monitor's power supply.

2. Open the printer’s panel.

3. Extend the swab moistened with absolute ethyl alcohol to thermosensitive element portion of

printhead (very thin black thermal tape on visible part of the print head), and gently wipe by moving around,

especially wipe several time in the area which cannot be clearly printed. A few minutes later after finishing the

wipe, then restart up to make confirmation.

4. If the phenomenon is not completely eliminated, repeat step 3 until satisfied.

6.7 Ordering Information

The recognized components, which will be purchased by HBME or by delegating HBME, used for fetal

monitor/ multi-parameter monitor are as follows:

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Accessories (spare parts) Part No. Specifications

Coupling agent T00-J005A005 viscous water-based compound / 250g

Printing paper T00-J005A004 152mm * 90mm-150P

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Chapter 7 Alarm
 This chapter describes the general information on the alarm and the measures to be taken when an

alarm occurs.

 Please see sections describing each parameter setting for more information on each parameter alarm

and prompt message.

7.1 Overview
Alarm means that the monitor gives the user prompt when changes in vital signs of monitored patient

requiring enough attention occur or the monitoring on the patient fails to proceed smoothly due to fault of the

machine itself.

7.2 Alarm Properties

7.2.1 Alarm Type
Alarms are classified into two categories: first, an alarm arising from the change in monitored patient’s vital

signs, that means the patient's physiological parameters exceeding a specific range or the occurrence of

physiological abnormality which cannot be measured by breaking bounds of single physiological parameter,

also referred to as physiological alarm; Second, the alarm arising from the machine itself, which means that the

patient can’t be accurately monitored due to technical barrier or the fault of monitor itself, and such alarm is

referred to technical alarm.

7.2.1.1 Physiological Alarm

Alarms are immediate alarm just except fetal heart rate alarm delay.

Physiological alarms: often referred to as parameter alarms, meaning that an alarm is triggered when some

physiological parameters of the patient exceed the limit.

Physiological parameters of an alarm event when all of the following three conditions are met:

1) Alarm switch has been turned on;

2) Parameter value exceeds the limit, and off-limit duration exceeds the value set for alarm delay;

3) An alarm event occurs during non-alarm pause.

The physiological parameter alarms for this monitor are as follows:

FHR 1 : high / low temperature value: high/low

FHR 2: high/low blood oxygen value: high/low

Systolic blood pressure: high/low pulse rate value: high/low

Diastolic blood pressure: high/low Mean blood pressure: high / low

Alarm switch may be set up according to "Fetal Parameters Alarm", "Blood Pressure and Blood Oxygen

Parameter Alarm", "ECG Temperature Parameters Alarm" in the "Alarm Setting" of main menu.

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Note: parameter off-limit alarm switch for the monitor under default state is set "Off."

7.2.1.2 Technical Alarm

The technical alarms for the monitor mainly include:

Alarms for abnormal printing state of the system mainly include:

Printing door is not closed

Out of paper

Alarms for abnormal state of the system mainly include:

Cuff leakage, pressure measuring timeout

Prompt messages used by the monitor include “coincidence of fetal heart rate" and "low battery"

7.2.2 Alarm Mute / Reset

Alarm Mute: Alarm mute state means that any sound prompt of the monitor (including sounds for alarms, keys

and pulse) has been turned off.

Monitor can be set, press the icon ( ) for a very short time to enter the alarm mute , the

alarm sound will be turned off until a new alarm event occurs; if press the icon for a relatively long

time, the monitor will enter alarm pause state which is up to 2min. During the alarm pause,

alarm will not be given even if a new alarm event occurs.

7.2.3 Alarm Level

Whether technical alarm or physiological alarm has a corresponding alarm level respectively, requiring

medical staff to treat differently. The physiological alarms for the monitor may be classified into high, medium

and low-level, but technical alarm is fixed at a low level.

7.2.4 Alarm Pause

Disable all alarm beeping.

Disable all text message for physiological alarm.

Disable all text message for technical alarm.

The remaining seconds for alarm pause is displayed in the description area of physiological alarm.

7.2.5 Sounds and Lights Characteristics for the Alarms at Different Levels
Alarm level Characteristics of alarm sound Characteristic of alarm lights

High Mode is "beep - beep - beep - beep - beep, beep - beep - Alarm light flashes in red

beep - beep - beep", sounds once every 10 seconds

(interval counting is from the beginning of this sound to

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the start of next sound.)

Medium Mode is "beep - beep - beep”, sound once every 25 Alarm light flashes in

seconds (interval counting is from the beginning of this yellow with slow flashing

sound to the start of next sound.) frequency

Low Mode is "beep - beep ", sounds once every 25 seconds Alarm light is

(interval counting is from the beginning of this sound to yellow when it keeps on

the start of next sound.)

Note
When multiple levels of alarms occur simultaneously, sound for the highest level of alarm will dominate.

Alarm pause function will be activated when press the key for a long time. Alarm mute / reset

function will be activated when the key is pressed for a very short time.

The alarm mute / reset function is controlled by controlling the alarm sound. Alarm is given when alarm

light flashes, and message suggests that alarm is uncontrolled.

7.2.6 Alarm Method

Three methods including sound, flashing alarm light and text message are available for alarm.

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Chapter 8 Printer
8.1 Installation of Printing Paper

Printer Door

Installation of Printing Paper

The steps for installing printing paper are as follows:

1. Open the printer door: clasp the buckle of printer with hands and pull out to open the printer door, as

shown in Figure 8-2 (a). Keep a set of printing paper flat in the box of printer, and unfold the first page: as

shown in the figure.

2 Pull a small part of the paper out, ensure that paper is straightened and paper edges are aligned.

3. Close the printer door.

Note

If the printer door is not closed well or paper is not available in the printer, the instrument will sound an alarm,

alarm light will turn yellow, and message “the printer door is not closed” or “out of paper” will appear in the

message area.

8.2 Print Setting

Rotate and press the encoder disk to enter the system parameter interface for print setting:

Printing speed: three options including 1cm / min, 2cm / min, and 3cm / min are available for adjusting

printing speed.

Printing density: five options including grade are available for adjusting darkness of print curve.

The following four operations are to ensure that you can print with 152mm printing paper in different

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specification:

Adjust printing position of uterine contraction 0

Adjust printing position of uterine contraction 100

Adjust printing position of fetal heart rate 90

Adjust printing position of fetal heart rate 210

The adjustment method is as follows:

In the system parameter interface, rotate encoder disk to select any one of the above four options, press the

encoder disc to confirm to be in adjustable state, the printer starts printing. Four lines will be printed out on

printing paper at the positions for uterine contraction 0, uterine contraction 100, fetal heart rate 90 and fetal

heart rate 210 respectively. If there is a position deviation in some parameter, rotate encoder disk to adjust

position when this parameter is in adjustable state to make position coincide. When the adjustment is

completed, press “enter “on the encoder disc to stop printing .

8.3 Print
When you need to print, please press the print button. When the printer is working, the printing icon is

dynamically displayed at the bottom of the screen, indicating the printing has started. Printing may be stopped

at any time by just pressing print button. Under the frozen state, user can print all the data currently displayed

for a pregnant woman.

Clear paper jam

When you hear the abnormal recorder running sound or see unusual output of recording paper, you should

open the door to check whether jam has occurred. The steps for clearing paper jam are as follows:

1. Open the printer door;

2. Remove the jammed paper inside the printer;

3. Pull out a small part of the remaining paper, and ensure that two sides of the paper are substantially parallel

to left and right edges of print door;

4. Gently close the print door.

8.4 Cleaning of Printhead

The time between failures of thermal print head is more than 20 years; this is just guarantee for electrical

aspects. Printing paper or the cleanliness of operating environment has a great impact on the printing effect.

When the printed content is not clear or the partial region is unable to be printed out, the priority work is to

clean the print head, and the methods and steps are as follows:

1. Turn off the monitor's power supply.

2. Open the printer’s panel.

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3. Extend the swab moistened with absolute ethyl alcohol to thermosensitive element portion of

printhead (very thin black thermal tape on visible part of the print head), and gently wipe it by moving around,

especially wipe several time in the area which cannot be clearly printed. A few minutes later after finishing the

wipe, then restart up to make confirmation.

4. If the phenomenon is not completely eliminated, repeat step 3 until satisfied.

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Chapter 9 Monitoring of Fetal Heart Rate

■ Brief introduction

■ FHR setting

■ FHR monitoring

■ Common symptoms of fetal monitoring

■ cleaning & maintenance

9.1 Brief Introduction

Fetal heart rate monitoring is based on the Doppler Effect. We know that a certain frequency of ultrasound will

be reflected when it encounters an obstacle during its propagation. If the object is stationary, the frequency of

reflected wave is the same as frequency of the transmitted wave. Once the object moves, the reflected

frequency will change, the frequency of reflected wave for the object moving towards the acoustic source will

become higher, and the frequency of reflected wave for the object moving towards the opposite direction of the

acoustic source will become lower. Additionally, the greater the rate of movement of the object, the greater

change in the frequency, this effect is called Doppler Effect. Clinically, ultrasound is transmitted towards the

human body with an ultrasonic transducer, and when the ultrasound encounters locomotive organs such as the

heart, resulting in changes in the echo signal. The heart rate will be derived from echo signals processed.

The position where fetal back faces maternal abdomen is best suitable for monitoring with Doppler. If the

fetus’s face is against the mother's womb, his/her hands and feet will affect echo. The turn-back of fetus results

in the heart deviation from the probe irradiation area, and the echo signal weakens; some of the Doppler

components disappear.

Connecting position of FHR probe

Fig. 9-1 Right Panel

Connecting positions of fetal heart probe include FHR1 triad probe socket and FHR2 secondary probe

socket, as shown in Fig.9-1.

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Warning
Please use the accessories provided or recommended by the manufacturer.

9.2 FHR Setting

FHR setting includes: curve separation (set up in case of twin), alarm upper limit, alarm lower limit,

alarm setting, alarm volume, fetal sound channel (set up in case of twin).

As for setting method and the detailed parameters, see the relevant sections.

Note

FHR alarm upper limit is generally set to 160bpm, and the lower limit is set to 120bpm.

It is recommended that alarm setting is set to “on”, to facilitate the timely detection of fetal heart rate

abnormalities.

9.3 Monitoring of Fetal Heart Rate (FHR)

Fetal heart rate measurement is a method in which FHR is obtained through the maternal abdominal wall. After

putting the ultrasonic probe on the maternal abdomen, the sensor emits low-energy ultrasonic signal to the fetal

heart, and receives echo signals from the fetal heart.

During fetal monitoring, user should be aware of the followings:

1) A pregnant woman takes an easy-care posture, usually half supine position.

2) Cross the strap from below the waist (two straps should be used when fetal heart rate and uterine

pressure are monitored).

3) Apply appropriate amount of coupling agent on the surface of ultrasound probe. Put the probe on the

abdomen of pregnant women, and ensure the coupling agent makes the probe contact with the pregnant

belly well. Ultrasound signal is the best when the probe is located behind the left shoulder of fetus. After

the probe is placed, move and adjust it slowly till the best position is located. At this point, the fetal

heartbeat sound is strongest in the speaker and continuous fetal heart rate is displayed on the screen.

4) The probe stays at this best position and is fixed with straps. If the probe has shifted, adjust the

position of the probe in order to get the best signal.

5) Do not turn off speaker volume during the monitoring process. When the fetal heart rate signal is

very weak, and fetal heart sound from the speaker is hardly heard, FHR value displayed on the screen at

this time is probably not meaningful.

6) After fixing the ultrasound probe, press the ▲ or ▼ keys to adjust the volume till an appropriate

level.

9.3.1 Methods and Procedures for FHR Signal Acquisition

1) To find the position of strongest fetal heart rate with a stethoscope or touch the fetal position with

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hands till find the best position for fetal heart rate;

2) To apply coupling agent evenly on the surface of the ultrasonic probe;

3) To put ultrasound probe on the fetal side of pregnant woman, and move the sensor slowly to listen to

the fetal heart signal until find the clearest signal to fix the monitor here on the abdomen of pregnant women;

4) To fix the ultrasound probe with straps, and properly adjust ultrasound to make the signal clear and the

instrument accurately count; when fetus is at head position, usually the best position is deviation to left or right

below the navel; when fetus is at breech position, the best position may be at upper part of maternal belly;

5) To check whether the monitor displays fetal heart rate value. In the monitoring process, the monitor

remains clearly audible volume of regular fetal heart beat. Be sure not to turn off the monitor sound

completely;

6) When there is a strong fetal movement, uterine contraction or maternal body movements, fetal position

is likely to change greatly and it is possible to fail to hear a clear fetal heart beat, you need to adjust the

position of the ultrasonic probe in order to regain excellent fetal heart signals.

Note

Only if the probe is placed in the best position, can the best quality monitoring records be obtained.

Warning

Be sure not to turn off speaker volume during the monitoring process. When the fetal heart rate signal is

very weak (fetus is abnormal or fetal heart deviates to the edge of detection area of the probe), or

fetal heart rate signal is not available (fetal heart deviates out of detection area of the probe or dead

fetus), fetal heart sound rhythm is hardly heard from the speaker, then special attention shall be paid that

FHR value displayed on the screen at this time is pointless.

9.3.2 Monitoring of Single Fetus

This means monitoring single fetus. Find the position of fetal heart and tie ultrasonic probe in accordance

with methods and procedures for FHR signal acquisition in 9.3.1. The monitor will display FHR value and its

corresponding curve during the monitoring. When the fetal heart rate is greater than upper alarm limit or less

than lower alarm limit, the indicator light on the front panel of monitor turns from green to red and flashes. If

duration of FHR exceeding limit is longer than the set alarm delay value, the monitor will sound an alarm in

the case of turning on the alarm, and the following message will appear at the bottom of the screen:

AL_FHR1 HI FHR 1 too high

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or

AL_FHR1 LO FHR 1 too low

The alarm icon will appear above the fetal heart rate curve; if the alarm is not turned on at this time,

no alarm message or alarm icon will appear.

9.3.3 Monitoring of Twins

This means monitoring twins. Find the position of fetal heart and tie ultrasonic primary probe and secondary

probe in accordance with methods and procedures for FHR signal acquisition in 9.3.1. In order to ensure

clearly observe twin curves, it is recommended to set separation value of twin curves (i.e. value other than 0).

Curve separation: when twins are monitored, curve separation means that several unit points in the

FHR 2 curve lower than its real heart rate can be displayed, so as to make FHR 2 curve not to coincide with

FHR 1 curve. This unit point is the value of curve separation, and four options including 0, 10, 20 and 30 are

available. 0 means no separation. If you select 20, this indicates that FHR 2 curve drops 20BPM compared

with its real curve. The second FHR value displayed on the right parameter area is real value which is not

affected by the curve separation setting.

By setting the fetal sound channel, user may determine the output sound is from primary probe

（FHR1）or secondary probe（FHR2）.

The monitor will display two FHR values and their corresponding curves during the monitoring. When

any fetal heart rate is greater than upper alarm limit or less than lower alarm limit, the indicator light on the

front panel of monitor turns from green to red and flashes. If duration of FHR exceeding limit is longer than

the set alarm delay value, the monitor will sound an alarm in the case of turning on the alarm, and the

following message will appear at the bottom of the screen, while alarm icon will appear above the FHR

curve. Otherwise, if the alarm isn’t turned on at this time, no alarm message or alarm icon will appear.

If user monitors a fetus with twin monitor, he/she should select FHR1 as the fetal sound channel;

otherwise fetal heart sound will not be heard.

9.4 Common Symptoms Analysis of Fetal Monitoring

Normal baseline fetal heart rate ranges 120~160 beats/ min (BPM). Change in baseline means the change

lasting more than 15 minutes.

(1) Fetal tachycardia:

This means baseline heart rate is more than 160BPM. The factors related to or contributing to tachycardia

include: fetal hypoxia, maternal fever, maternal hyperthyroidism, fetal anemia, amnionitis etc. Fetal

tachycardia is usually accompanied by the disappearance of heart rate variability.

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(2) fetal bradycardia:

This means baseline heart rate is less than 120BPM

(3) Heart rate variability:

At any given time, an important feature for pre-estimating fetal status is heart rate variability, reflecting

whether the controlled capacities for neurological regulatory system of fetal heart and cardiovascular system

are sound. The variability includes short-term and long-term variability.

Short-term variability means irregularity between heartbeats and is due to the error normal cardiac

electrical activity cycle.

Long-term variability means fluctuation of heart rate curve.

Acceleration means the periodical change in heart rate above fetal baseline heart rate, and is related to

fetal movement and uterine contraction.

Deceleration means the periodical change in heart rate below fetal baseline heart rate. Different from

the change in baseline, deceleration lasts relatively short time, typically less than 10 minutes. According to

the curve and relation with time of uterine contraction cycle, deceleration can be classified into the

following three categories:

① early deceleration

The obvious feature is that the fetal heart rate begins to decline before uterine contraction, and returns to

baseline after the end of uterine contraction. Generally, this is due to fetal brain being under pressure.

② late deceleration

The obvious feature is that the fetal heart rate begins to decline only after uterine contraction starts, and

returns to baseline after the end of uterine contraction. Generally, this is due to fetal hypoxia.。

③ variable deceleration

Variable deceleration means that FHR curve varies in shape, starting time and duration, and it is most

common during childbirth, usually due to umbilical cord compression.

9.5 Cleaning & Maintenance

Caution
If you see the phenomenon of deterioration or damage, please replace the cable. In this case, do not

monitor patient by using this cable.

9.5.1 Cleaning of the Probe Cable

In order to keep free of dust, the probe cable should be cleaned with a lint-free cloth moistened in one of

authorized cleaners or moistened in non-corrosive detergent which has been diluted in warm soapy water

(up to 40 ℃ / 104 ℉).

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Recommended cleaners and trademarks:

Soap: mild soap

Detergent for Tensides dishwasher: Alconox

Ammonia water: diluted ammonia water <3%, window cleaner

Aldehyde-based Ethanol: 70%; isopropanol:70%; window cleaners

9.5.2 Sterilization of Cable

In order to avoid long-term damage to the cable, we recommend you to sterilize cable only when it is

required by relevant hospital sterilization procedures. We recommend to clean first before other actions.

Recommended sterilization material:

Aldehyde-based ethano:l 70%, isopropyl alcohol: 70%

9.5.3 Processing Cables to Prevent Cross-contamination

In order to avoid long-term damage to the cable, we recommend you sterilize cable only when it is required

by relevant hospital sterilization procedures. We recommend to clean first before other actions.

Caution
Do not use a pressure cooker or bleaching agent containing sodium hypochlorite for disinfection of cables.

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Chapter 10 Monitoring of Uterine

Contraction Pressure
■ Brief introduction

■ Uterine contraction Setting

■ Monitoring of uterine contraction pressure

■ Reset mark of uterine contraction:

10.1 Brief Introduction

Monitoring of uterine contraction pressure means external measuring of uterine activity by placing a

TOCO sensor on the abdomen of a pregnant woman.

Externally measurement and record of the relative pressure changes are shown in the following

figure.

Fig. 10-1 Schematic Diagram of Uterine Pressure Monitoring

Monitoring of uterine contraction pressure means monitoring the situation of uterine contraction. Uterine

contraction pressure is an index of childbirth strength, clinically uterine contraction status may directly

affect fetal heart activity and childbirth.

The curve recorded by pressure monitor may provide a lot of information such as the strength, frequency

and duration of uterine contraction, regularity and shape. Additionally the contraction can speed up or slow

down fetal heart rate. If fetal heart rate monitoring is combined with uterine pressure monitoring, medical

personnel can diagnose change in fetal heart rate by referring to the status of uterine contraction. Monitoring

of external pressure means obtaining condition of uterine contraction pressure from maternal abdomen.

When uterine contraction occurs, the tension of abdominal wall oppresses the pressure sensor placed on it,

the sensor converts such stress into electrical signal, which will finally be output/displayed or printed out
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after amplification processed by instrument.

10.2 Uterine Contractions Setting

Setting items for monitoring of uterine contraction pressure :

TOCO REFERENCE (uterine contractions reset): five optional values including 0, 5, 10, 15 and 20 are

available.

Strength of uterine contractions will be displayed with selected value as benchmark.

10.3 Monitoring of Uterine Contraction Pressure

1. Preparation of the monitor

2. Connection of the probe

 A strap is across the back of the pressure probe, which has been placed at the bottom of the

pregnant woman's uterus and fixed well. Adjust the position of the strap to ensure appropriate

tightness.

 Press the reset button for uterine contraction pressure, and the location of uterine contractions

on the screen will display reset value of uterine contraction pressure.

Warning
Do not monitor a patient underwater.

3. Collection of data of uterine contraction pressure

The strap should be appropriately fixed. If the strap is too tight, the contraction peak may have a flat top and

the peak is below 100 in pressure scale; if too loose, the probe may slide, resulting in abnormal readings.

Adjust the strap pressure as needed.

Note

Do not use ultrasonic coupling agent on TOCO sensor or the contact area of the sensor.

4. Adjustment of monitor

Press the reset button for uterine contraction on the front panel to adjust the pressure to the reset value.

Press the reset button once, and a reset icon will be displayed on the main interface. Repeatedly press

the reset button for uterine contraction within five seconds, but only one time is effective.

Note

Pressure adjustment only can be carried out in the intermittence between two uterine contractions.

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Chapter 11 Monitoring of Fetal Movement and

Awakening of Fetus
■ Brief introduction

■ Monitoring of fetal movement

■ Awakening of fetus

■ Automatic mark of fetal movement : ; manual mark of fetal movement : ; mark of awakening

device:

11.1 Brief Introduction

Fetal activity in uterus is called fetal movement, including fetal limbs movement, vibration, rotation of fetal

head and body, tumbling. As one of objective signs of fetal life, fetal movement is motion signal sent to the

mother. The presence or absence of fetal movement is directly related to the safety of the fetus. The

obstetrician usually uses status of fetal movement as an important indicator to observe whether the fetus is

in good development. Thus, pregnant woman and obstetrician must timely grasp the physiological

information on fetal movement.

Monitoring of fetal movement is classified into automatic and manual fetal monitoring. Automatic

monitoring of fetal movement means that signal of fetal movement is converted into electrical signal by

sensor, and information on fetal movement will be captured by automatic recording instrument after the

amplification processing of instrument. Manual monitoring of fetal movement means, during the monitoring

of pregnant woman, to manually mark the information on fetal movement by using related accessories

according to fetal movement.

11.2 Monitoring of Fetal Movement

This monitor has functions of automatic and manual fetal movement monitoring.

Setting items of fetal movement monitoring include:

AFM (fetal movement curve)

FM COUNT (fetal movement counting)

FM THRESHOLD (fetal movement threshold)

For setting method of specific parameter, see the relevant sections.

During monitoring by automatic fetal movement, if the system automatically records fetal movement

for once, the main interface will display a fetal movement marker.

Note

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 Fetal movement waveform and uterine contraction are jointly displayed on the same channel.
 Automatically measured results of fetal movement may be affected by the following factors: fetal
movement, maternal body movements, and other external interference.
So during monitoring, user should first reduce the external interference (such as touching pregnant
women, beds movement, etc.), and make pregnant women to keep quiet, in order to get more accurate
results of the automatic fetal movement.
 When pregnant woman receives monitoring of fetal heart rate, hold the marking device in your hand;
press the button on the top of marking device when feeling fetal movement to make FM counting increase
by one, and the main interface will display a marker for pregnant woman event.
11.3 Awakening of Fetus
Awakening of fetus means a certain amount of stimulation is given to fetus by fetal awakening device, in order
to awaken the sleeping fetus. Awakening of fetus applies non-stress test (NST) to avoid misjudgment of
obstetricians on the NST results. NST means that user observes and records the fetal heart rate and uterine
contraction figure in the absence of uterine contractions or other external load stimulus. This is an ideal
approach to determine the status of the fetal placental function.

11.3.1 Awakening Device of Fetus

Fig. 7-1. Awakening Device and Connection Line

① Power switch

Press this switch to begin operating instrument, and press again to stop operation.

There are two modes of operation: continuous mode in which as long as user presses the switch, the instrument

operates; 3-time mode in which the instrument will automatically stop after three operations.

② Optional mode switch

Continuous mode or three-second mode is optional.

③ Socket of marking device

This socket is connected with the fetal monitor through the audio cable.

④ FAST, SLOW knob

Used to adjust the rhythm of vibration during operation (intermittent repetition cycle).

⑤ Vibrating head

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Surface of vibration

⑥ Battery box

Use two alkaline batteries.

⑦ Audio cable

The audio cable is connected to a fetal monitor. Prompt message will be automatically displayed when

the vibration sound pulse occurs.

11.3.2 Preparation of Operation

(1) Open the fetal awakening device to check whether it can work properly. If there is a problem, be sure not to

use it;

Install battery before using and close the battery box cover, the specific steps are as follows:

 To remove the battery box cover

Fig. 7-2 Removal of Battery Cover

Battery box cover may be removed by inserting coin-like or forceps-like flat object at the position shown as

the arrow in left below figure, and pressing down the battery box in the direction of the arrow (as shown in Fig.

7-2)

 To install batteries
The two alkaline batteries are put into battery box according to the polarity indication inside the battery

box (positive and negative electrodes of battery correspond to the electrodes indicated inside battery box

respectively), and close the battery box cover, as shown in Figure 7-3.

Fig. 7-3 Installation of Battery

 To remove the battery
Press negative side (Θ) of the battery with one finger to remove the battery.

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Caution
If the instrument will not be used for a long time, user should promptly remove the battery.

Note
① Do not mix old and new batteries or batteries of different types up when using batteries;
② Do not disassemble the battery to avoid battery leakage or rupture
(2) Connect the fetal awakening device to the interface of fetal awakening device at the rear of the monitor.
Connection example is as follows:

Connect one end of the audio cable to the socket for fetal awakening device.*Audio cable is classified into

single and dual-channel types. Fetal monitors produced by different manufacturers may have different

requirements for audio cable. Both the audio cables are applicable to HBME’s monitors.

(3) When the mode key is pressed once, the awakening device will be alternately switched between

three-time mode (automatic termination after vibrating 3 times) and continuous mode.

11.3.3 Awakening of Fetus

Place vibrating head surface of the instrument on the maternal abdomen, and press down the vibration

switch to vibrate; the vibration stops when the finger looses it. Under normal circumstances, the vibration

can awaken the fetus. When you start the fetal awakening device, a marker for fetal awakening device will

appear on the main preface.

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Chapter 12 NIBP Monitoring

■ Brief Introduction

■ NIBP measurement

■ Cleaning and maintenance

12.1 Brief Introduction

Blood pressure means strength for the heart pumping out blood and the pressure on vessel wall by blood

flow. Blood pressure is an important physiological parameter reflecting function of human circulatory

system. Thus blood pressure monitoring is of great importance in clinical practice.

Blood pressure may be measured by being converted into electrical signals through blood pressure

transducer. The measurement methods are classified into direct and indirect measurements. Direct

measurement method is accurate, and can track an instantaneous change in arterial blood pressure, but

catheter must be percutaneously put into the vessel for measuring, causing trauma on human body; thus it is

generally limited to critically ill patients or open-heart surgery patients. Indirect method is simple and

noninvasive, with smaller interference on the human body, is commonly adopted measurement method

clinically. Indirect methods of blood pressure include auscultatory method, ultrasonic method, oscillometric

method and double-cuff method. Our products adopt the oscillation method, which is also currently used by

most of noninvasive blood pressure monitors in foreign countries.

Oscillometric method is also known as vibration measurement method or oscillometry . Oscillometric

method still uses inflatable cuff to block blood flow of artery. User may detect pressure oscillations waves

arising from pulse of blood flow in artery in the cuff. First, the cuff is inflated to that about 20mmHg higher

than systolic blood pressure, then slowly deflate cuff till blocked artery occurs due to that cuff pressure is

higher than systolic blood pressure. The oscillation wave of smaller amplitude will occur due to proximal

blood pulsation. The oscillation amplitudes increase when the inner cuff pressure equals to systolic pressure.

With gradually decreased inner cuff pressure, the oscillation amplitude continually increases; when the inner

cuff pressure reaches a certain value, the oscillation rate will become maximum, the cuff pressure at this time

is the mean arterial pressure. Based on the variation characteristic of oscillation amplitude subject to different

cuff pressures, oscillometric method may identify the mean arterial pressure and thereby derive systolic and

diastolic arterial pressure from this mean pressure.

12.2 NIBP Measurement

Noninvasive blood pressure (NIBP) measurement adopts the oscillometric method.

Measuring modes: manual / automatic mode. Each mode can display systolic, mean and diastolic blood

pressures.
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Under "Manual" mode, only one measurement will be finished.

Under "Auto" mode, the measurement is repeated. Time interval can be set as: 3/5/10/20/30/60/90/120/240

minutes.

Note
 Do not carry out non-invasive blood pressure measurement for a patient with from sickle cell disease
or skin lesions or anticipated to suffer from damage.

 For a patient with severe disturbance of blood coagulation, user should determine whether to carry out
the automatic blood pressure measurement according to the clinical evaluation, since risk of

hematoma will exist where the limbs rub cuff.

 If a pregnant woman has too low or too high heart rate or irregular severe arrhythmia, user can’t
measure the blood pressure.

 If a pregnant woman has irregular heartbeat due to arrhythmia, the measurement result will be
unreliable or measurement time will be longer.

 When a pregnant woman is moving, trembling or in a spasm, the measurement will be unreliable or
impossible, because these activities may interfere with the detection of arterial pulse.

 When a pregnant woman is in extreme shock, or has low body temperature, the reading will be
unreliable, because the reduction in peripheral blood flow can lead to a reduced arterial pulsation.

When cuff is placed on the limb which receives intravenous drip or is fitted with SpO2 sensor, this

will be detrimental to drip or SpO2 sensor and thus must be avoid. A pregnant woman must adopt the

supine position. When the position of the cuff is at the heart level, measurements are most accurate,

otherwise other positions may lead to inaccurate measurements.

Warning

 Do not install the cuff on the limb which is given intravenous infusion or is inserted catheter.
Otherwise, during inflation of the cuff, damage to around the catheter is likely to occur in the

case of slowing down or blockage of infusion.

 Be sure to keep inflation tube connecting cuff of blood pressure with monitor unobstructed, without
tangle.

 Be careful when measuring a pregnant woman with sickle cell disease, because a person with severe
bleeding tendency may have local bleeding!

 Prohibit measuring blood pressure on a limb receiving transfusion or with intubation! Prohibit tying

cuff for a patient with local skin lesion!

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12.2.1 Measurement Method

1. Insert the inflatable tube into a interface of blood pressure cuff for the monitor, and turn on the

instrument.

2. Tie blood pressure cuff on upper arm or the thigh of patient in accordance with the following

methods (Fig. 12-1).

※ Confirm the cuff is completely deflated.

※ Use the appropriate size cuff for a patient to ensure notation φ is located just above the artery. Be

sure the limb is not wrapped around with cuff too tight; otherwise it may cause distal limb

discoloration or even ischemia.

※ The cuff should be appropriately tight, and it is better to be inserted two fingers.

※ Mark φ is placed at a position with the most obvious brachial artery pulse.

※ The lower end of cuff should be 2 cm higher than the elbow.

Fig. 12-1 Use of Cuff

※ Cuff width should be 40% (50% for newborn) of the limb circumference, or 2/3 of the length of the upper

arm. The length of inflatable part of cuff should be sufficient to surround 50 to 80 percent of the body, and the

wrong size cuff will produce erroneous readings. If cuff size has problem, need to use a bigger cuff to reduce

errors.

3. Connect the cuff to inflatable tube. The limb used to measure blood pressure and the patient’s heart

should be in the same horizontal position. If you cannot do it, please use the following correction

methods to correct the measurement results:

※ If the cuff is higher than the heart level position, 0.75mmHg(0.10kPa) every centimeter gap should be

added to the display value.

※ If the cuff is lower than the heart level position, 0.75mmHg(0.10kPa) every centimeter gap should be

subtracted from the display value.

4. Select measurement time interval in the item "measurement interval (NIBP INTERVAL)”, please

see the following "Operation instruction" for specific methods.

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5. Press the button for blood pressure measurement on the front panel to inflate and measure blood

pressure.

6. If the monitor fails to measure the blood pressure after inflation, and will automatically inflate for

second time and the inflation pressure increases by about 50mmHg. This process may be repeated at most

three times.

12.2.2 Operation Instructions

1. Perform an automatic measurement

After selecting item "measurement interval (NIBP INTERVAL)" , the user can select the time

interval value for automatic measurement. Then, press NIBP button on the front panel to start first

measurement, after which the system will perform automatic inflating and measuring in accordance with set

time interval.

2. Stop the automatic measurement

During the process of automatic measurement, user may stop the automatic measurement at any time

by pressing button for blood pressure measurement.

3. Perform a manual measurement

Select item "Manual" as measurement mode, and then press the button for blood pressure measurement

on the front panel to start manual measurement once. In manual measurement mode, the measurement time

interval is invalid.

4. Perform a manual measurement in automatic measuring process

In the spare time during automatic measurement, user may press the button for blood pressure measurement to

start manual measurement once. In the measuring process, automatic measurement will stop and resume

automatic measurement if pressing the button for blood pressure measurement again.

Warning
If non-invasive measurement time under the automatic mode is too long, the limb rubbing the cuff may

be accompanied by purpura, ischemia and nerve damage. When monitoring a patient, user should check

color, warmth and sensitivity of distal limb. Once observing any abnormalities, put the cuff on another

place or immediately stop the blood pressure measurement.

12.3 Cleaning & Maintenance

Warning
 Do not squeeze the rubber hose on the cuff.

 Do not allow water or cleaning fluid to flow into connector socket of the monitor to prevent damage

to the instrument.

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 When cleaning the monitor, only need to wipe the outer periphery of the connector socket, and do

not wipe its inside.

The cuff is reusable, and can be sterilized by autoclaving in a conventional hot air oven, or by gas or

radiation sterilization method, or is immersed in the decontamination solution to be sterilized. But keep in

mind that user should remove rubber bag when using this method. Dry cleaning must not be used for the cuff.

Machine wash or hand wash can be used for the cuff, and hand wash can extend the useful life. Remove the

rubber bag before cleaning. When the cuff is completely dry after washing, re-load the rubber bag, as shown in

Fig. 12-2 and Fig. 12-3.

Fig. 12-2 Replacing Rubber Bag in the Cuff Fig.12-3 Replacing Rubber Bag in the Cuff

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Chapter 13 SPO2 Monitoring

■ Brief introduction

■ Blood oxygen monitoring

■ Precautions

■ Factors affecting readings

■ Cleaning and maintenance

■ Fault and exclusion

13.1 Brief Introduction

Pulse oxygen saturation function of SpO2 means the percentage of oxygenated hemoglobin accounting for

the sum of oxyhemoglobin and deoxyhemoglobin.

Oxygen monitoring using optical technology can continuously measure arterial blood oxygen

saturation in arterial blood. Conventional oxygen probe used for monitor is finger clip probe, which is set on

the finger when using.Two juxtaposed light emitting diodes (LED) giving out wavelength of 660nm red

light and 890nm infrared light are fixed on the upper wall of the probe. Photodetector on the lower wall of

the probe can convert the red and infrared light transmitted through the finger arteries into electrooptical

signal, whose pulsation is consistent with the heart beat, thus the repetition period and pulse rate of signal

are detected.

Warning
The sensitive electronic components inside the sensor may be damaged in case of maltreatment. Protect
the cable away from in contact with sharp edges of objects. The abrasion due to patient motion and

normal cleaning the sensor will shorten the life of SpO2 sensor.

Any damage due to incorrect use is not guaranteed by the Company.

Warning

 During magnetic resonance imaging, user should ensure that the position of the cable will not form an
inductive loop to prevent causing burns. If the sensor doesn’t work properly, immediately remove the

sensor from the patient.

 Don’t affix SpO2 sensor at ambient temperature exceeding 37 ℃, to prevent serious burns due to long
time adherence.

Caution
Injected dyes such as methylene blue, or intravascular stained hemoglobin (e.g. methemoglobin), may

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result in inaccurate measurements. Possible interference source known: ambient light is too strong ,
patient movement.
13.2 Blood Oxygen Monitoring
13.2.1 Blood Oxygen Probe
Finger clip probe for adults is reusable

Put the patient’s finger into the probe and ensure that the probe completely wraps finger.

13.2.2 Monitoring Steps

1) To turn on the monitor;

2) To clamp the blood oxygen probe on the patient’s finger, as shown in Figure 13-1

3) To insert the connector at the end of oxygen probe cable into the hole SpO2 in SpO2 module.

Fig.13-1 Placement of Blood Oxygen Probe on a Finger

Warning

Prohibit placing the prob on the limb armed with blood pressure cuff, arterial catheter or lumen tubing .

Confirm that the light emitter and the light detector are aligned along the same line, and all the light rays

are transmitted through the patient's tissue.

Note
 Confirm that the patient has no highly frequent movement.

 Applying probe in an environment strong light will lead to inaccurate measurement results, thus need to

cover up the attached site with opaque material.

 High frequency electrical interference, including self-generated electrical interference of host systems,

or electrical interference from the other scientific instruments connected to the system.

Warning

Continuous monitoring over a long time may cause skin reddening, blistering or pressure necrosis.

Therefore, user should regularly check the attachment position of the probe and change position of the probe in

case of declined quality of skin. Additionally, special status for a particular patient may require more frequent

inspection.
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13.3 Precautions
Warning

During the process of continuous monitoring for a long time, check the measurement site every about 2

hours for the peripheral circulation and skin condition. If there is adverse change, the measurement site shall

be timely changed.

In the long continuous monitoring process, the localization of the probe shall be periodically checked, to avoid

inaccurate measurement due to change in probe positioning arising from shifting.

Note

 Clean surface of the blood oxygen probe with 70% ethanol solution before/ after each use, however

the probe shouldn't be immersed in the solution completely.

 Do not use blood oxygen probe if its packaging or the probe has damage sign.

 Do not use radiation, steam or ethylene oxide for sterilization of the blood oxygen probe.

 Be careful when connecting cables to avoid the occurrence of entangled patients.

 If the testing site and the probe cannot be accurately located, this may lead to erroneous blood

oxygen reading, so the testing site and the probe should be re-positioned.

13.4 Factors Affecting Readings

1)Nails, particularly the violet and blue nails, which will decrease reading due to the same absorption. It

is recommended to wash away the nail polish before the measurement.

2) False nail will affect the detection part to penetrate tissue, thus affecting the measurement of blood

oxygen values.

3)A patient has low blood oxygen value.

4) A heavy smoker has high CO levels transiently, leading to high oxygen reading.

5) Injection of a dye or intravascular staining hemoglobin .

6) Potential interference sources known: ambient light is too strong , movement of patient .

7) Improper placement or incorrect use of the sensor.

8) Poor perfusion at the measurement site.

9) When Hb-CO, Met-Hb or a chemical agent is present, oxygen value may be high.

10) Venous rhythmic vibration.

11) Serious disorders of hemachrome function (such as hemoglobin and ferritin).

Incorrect placement will result in inaccurate pulse blood oxygen.

 Avoid SpO2 sensor being placed on the same site or limb with arterial catheter, pressure cuff and

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intravenous injection together.

 When fix SpO2 sensor using an additional adhesive tape, venous pulse will occur, leading to inaccurate

SpO2 measurements. The weaker the pulse, the smaller the pulse waveform, the more sensitive the

interference on measurement.

 Ambient light at higher levels will affect the measurement, bright light sources such as fluorescent lamps,

dual ruby light, infrared heaters, direct sunlight, etc. can cause inaccurate measurements or disabled

measurement.

 Violent activities of pregnant woman and extreme electro-surgical interference will affect the

measurement accuracy.

 Continuous use of finger-clip SpO2 sensor will produce discomfort or tenderness, especially to patients

with microcirculatory disorders. Sensor shall not be placed on the same finger over two consecutive hours!

Be sure not to place a sensor on the edema or vulnerable tissue!

Note
Same as with any measurement technology, it is impossible to obtain an accurate SpO2 readings in

following cases:

 Presence of carbon monoxide hemoglobin (COHb), methionine (Me+ Hb), sulfo Hb or dye dilution

medicine such as methylene blue, indocyanine green, indigo carmine in a pregnant woman’s body, or for

some pregnant women with jaundice, SpO2 reading measured by the instrument will be inaccurate.

 Owing that the measurement is based on the pulse of the small artery, inaccurate measurement will be

obtained when pulsating blood flow is weakened, such as caused by shock, cold or hypothermia, massive

blood loss, and using reduced blood drugs.

 Dopamine, alanine tetracaine, procaine, lidocaine, Bu Zuoka and other drugs can result in serious SpO2

measurement deviation.

 In the case of oxygen therapy, pulse oxygen cannot replace clinical observation or blood gas analysis of

ventilation, because at this time it is only available as evaluation of SpO2 and its circulation, and it might

be noted that, even if a pregnant woman has severe hypoventilation, her peripheral SpO2 may be normal.

 Some pregnant women with severe anemia can still show good SpO2 measurement values, so pulse

oxygen is only a reference value for anemic hypoxia and toxic anoxia.

13.5 Cleaning & Maintenance

Warning
Make sure power is off or the power cord has been unplugged before cleaning the monitor and probe.

Caution
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Do not sterilize the sensor with autoclave.

13.5.1 Cleaning of Probe

1) Clean the exterior of the sensor with a mild detergent solution, saline solution (1%), or one of the

following solvents:

Microzid (pure), Mucocit (4%), Incidin (10%), Cidex (pure), Sporicidin (1:16), Mucaso (3%), Buraton

(pure), alcohol (pure), Alconox (1:84 ), Cetylcide (1:63).

2) Use a dry cloth to wipe the sensor's exterior, and let it completely dry.

3) Wipe light emission and receiving parts of the sensor with a soft cloth moistened with detergent or

medical alcohol, then wipe it dry with a dry cloth.

4) Check the sensor and cable. If any sign of deterioration or damage occurs, do not use it to monitor the

patient.

13.5.2 Cleaning of Cables

Cable should be cleaned according to the following methods:

1) Wipe the exterior of the cable with an antibacterial soap water or alcohol, and be careful not to make the

liquid flow into the plug/connection points of cable.

2) Dry with a clean dry cloth.

Warning
Do not soak the probe in any liquid or allow liquid to flow into electrical connections.

13.6 Fault Phenomena and Troubleshooting

13.6.1 Absence of Blood Oxygen Value
Fault phenomena:
No oxygen waveform or value is available in the monitoring process,.

Inspection methods:
Check the finger clip probe to find out whether red light flashes, or the arm of inspected person is pressed, or

indoor temperature of monitoring ward is too low.

Solving methods:
If there is no flashing of red light inside the finger clip probe, this may be due to poor contact of wire

interface, please check interface part of extension cord and socket. In cold temperatures areas, try not to let

the patient's arm exposed to avoid influencing the measuring accuracy. Blood pressure and blood oxygen

measurements must not be conducted at the same side of the arm, so as to avoid influencing the

measurement due to the pressed arm.

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If channel of blood oxygen waveform displays "no signal reception”, indicating that there are problems in

communication between blood oxygen module and host, please shut down and start up again. If such message

still appears, please contact with biomedical engineer in the hospital or your supplier.

13.6.2 Intermittent Oxygen Values

Fault phenomena:
When measuring blood oxygen saturation, oxygen values may appear or disappear.

Inspection methods:
1) When performing long-time monitoring or surgery, the patient has vibration or severe movement,

resulting in intermittent oxygen values.

2) Check the blood oxygen extension cord.

Solving method:
Try to make the patient remain stable, if blood oxygen value is lost due to accidental hand movements,

this can be considered normal. If blood oxygen extension cord is damaged, replace it.

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Chapter 14 ECG Monitoring

■ Definition of ECG monitoring

■ Precautions

■ Monitoring steps

■ Maintenance & Cleaning

14.1 Definition of ECG Monitoring

Monitoring of ECG waveform may produce continuous waveform of cardiac electrical activity of the

patient, so as to accurately assess the physiological state of the patient at the time.

In order to obtain the correct measurements, user should make appropriate preparation for the patient's

skin, accurately place electrodes, and ensure normal connection of ECG cable. During normal display, the

monitor can display a line of ECG waveform.

※ Patient cable consists of two parts:

Trunk line connected to the monitor;

Lead device connected to the patient.

※ The random configuration of this instrument is five-lead wire.

14.2 Precautions
Warning
When connect the electrodes or the patient cable, you should absolutely ensure absence of contact with any

other conductive part or ground. In particular, be sure that all the ECG electrodes, including the neutral

electrodes, are attached to the patient to prevent their contact with the conductive components or ground.

Note
Do not use any electrical radiation equipment near the ECG measurement.

14.3 Monitoring Steps

14.3.1 Preparation
1) Preparation of the patient skin before the placement of electrodes .

※ Skin is a poor conductor, and therefore the preparation of patient's skin is very important for

obtaining a good contact between the electrode and the skin .

※ When necessary, shave the body hair where the electrode is placed.

※ Wash the skin thoroughly with soap and water.

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(Do not use ether or pure ethanol, because it will increase the skin's impedance).

※ Rub the skin to improve capillary blood flow in the tissue and removes skin debris and grease.

2) Install spring clip or snapper before the placement of electrodes.

3 ) Place the electrode on the body of the patient. If the electrode doesn’t contain conductive past, apply

conductive paste on the patient’s body before placement of electrodes.

4) Connect the electrode leads to patient cable.

5) Make sure that the monitor power is turned on

Warning
Carefully attach the electrode and make sure that it is in good contact.

Warning
Check whether the ECG electrode patch stimulates skin every day. If allergy sign occurs, replace

electrode or change its position every 24 hours.

Note

In order to protect the environment, the electrodes must be recycled or disposed appropriately.

Warning

Be sure to check whether leads are normal before the monitoring begins.

14.3.2 Installation of ECG Leads

The positions for installation of ECG monitoring electrodes are shown in Figure 14-1.

Right Above (RA): first intercostal space on midclavicular line at the right edge of the sternum

Right Lower (RL): at the level of the xiphoid on the midline of right clavicular

Center (C): fourth intercostal space at left sternal edge.

Left Above (LA)：first intercostal space at the intersection of midclavicular line and left edge of the

sternum

Left Lower (LA): at the level of the xiphoid on the midline of left clavicular

Figure 14-1 Placement of Conductivity Electrode

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Note
In order to ensure patient safety, all leads must be connected to the patient body.

Warning
When using a surgical electrical (ES) equipment, be sure not to place electrodes on grounding plate

near the surgical electrical equipment, otherwise ECG signal will meet a lot of interference .

14.3.3 ECG Parameter Setting

ECG parameter settings include:

ECG channel, ECG and ECG gain, please see 4.2.1 Setting Interface for Fetal and Maternal

Parameters for Specific Parameter Setting.

14.4 Maintenance & Cleaning

Warning

 You must turn off the power and disconnect the AC power before cleaning the monitor or probe.

 If any sign indicates that ECG cable is damaged or aging, replace it with a new cable.

Cleaning

The monitor and the probe surface can be wiped clean with medical alcohol, and then made dry naturally or

wiped dry with a clean dry cloth.

Sterilization

In order to avoid long-term damage to the cable, we advise that you sterilize the products only when it is

required by relevant hospital sterilization procedures. We also advise that sterilization products should first be

cleaned.

Recommended sterilization material for the monitors:

Ethanol-based: 70% alcohol, 70% ethyl propyl.

Disinfection

In order to avoid long-term damage to the cable, we advise that you disinfect the products only when it is

required by relevant hospital sterilization procedures. We also advise that disinfection products should first be

cleaned.

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Chapter 15 Temperature Monitoring

■ Temperature monitoring

■ Maintenance & cleaning

15.1 Temperature Monitoring

This monitor only has one temperature measurement channel, and can measure the temperature data with the

temperature probe.

Temperature measurement setting

If you are using a disposable temperature probe, you should insert temperature cable into the socket, and

then connect the probe to the cable. For reusable temperature probe, you can plug it directly into the socket.

Firmly attach the temperature probe to the patient body.

Temperature units comprise of Celsius and Fahrenheit. If you want to change the temperature unit, please

enter the menu of ECG temperature setting to adjust.

Warning
Check whether the probe cable is normal before monitoring starts.

Warning
Carefully take or place the temperature probe and cable. When probes and cables are not used, they should be

rolled into loose ring. If enclosed wire is pulled too tight, this will lead to mechanical damage.

Warning
A temperature measuring instrument must be calibrated once per year (or according to the time instruction in
the hospital procedures). When calibration is needed, please contact the manufacturer.

15.2 Maintenance & Cleaning

Warning
You must turn off the power and disconnect the AC power before cleaning monitors or probes connected to

monitors.

Reusable temperature probe

1) Temperature probe heating must not exceed 100 ℃. It only can tolerate the temperature ranging 80 ℃

~100 ℃ for a short time.

2) Do not disinfect the probe with vapor.

3) Only can disinfect it with detergent containing alcohol.

4) When using the rectal probe, you may need to cover it with protective glue.

5) When cleaning the probe, hold the head end well with one hand, and use damp lint-free cloth to scrub

the probe downward towards the coupling with the other hand.

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Appendix A Fault Finding and Troubleshooting

The quality and reliability of antepartum monitor are high. If you encounter any problems, please find

problems and perform troubleshooting according to the following table.

Phenomena Possible reasons Troubleshooting methods

Power cord is not plugged in; the

Check the power supply, power cord and
No display when boot power switch is not turned on; power
power switch
cut or poor power plug, poor sockets

LCD interface is normal Ensure the monitor in the non-frozen

state
upon start-up, but the
Monitor is in frozen state
cursor does not move

Poor connection between the probe

and the instrument;
Reconnect;
Fetal heart rate is not found due to
Re-adjust the position of the probe;
wrong probe position; No / too little Add coupling agent;
Abnormal fetal heart rate Re-adjust the position of the probe after
coupling agent is added;
the signal is restored;
Fetal / maternal movement; Replace the probe

Damaged probe

Poor connection between the probe

and the instrument; Reconnect;
Abnormal uterine Wrong probe location ; Readjust the probe position;
Fail to perform pressure reset; Perform pressure reset;
contraction pressure Wait uterine contractions in pregnant
Pregnant woman has no uterine
women
contractions

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Use a straight screwdriver for repairing

watches to adjust the potentiometer in
The uterine contraction Internal circuit of the pressure probe
the side-hole of pressure probe, and to
value has no change or
drifts; ensure the reading is zero when without
just has slight change
external force;
when pressure probe is Pressure probe is damaged

pressed Replace the pressure probe

There is no display or
Method of fetal movement counting The way to check and set fetal
print icon when the FM movement counting mode shall be
is in automatic mode manual.
button is pressed

Speaker is silent Volume adjustment is too low Turn up the volume

Paper moves but no print

curve is available. FHR Thermal printing paper is installed Check whether the thermal sensitive side
curve is printed at uterine reversely. is upwards and reload paper;
contraction area, while
uterine contraction curve Remove and reload the thermal sensitive
The left and right side of thermal paper.
is printed at fetal heart
rate area surface are installed reversely.

Print density is set too light; Adjust the print density;

The printing is not clear
Unqualified or deteriorated Replace the printing paper;
or part of the area cannot
printing paper is used; Clean the printhead according to the
be printed out
The thermal printhead is dirty. steps

Movement direction of
Adjust the direction and position of
paper deviates; Paper is not loaded well; printing paper;
Position of print curve A different brand of paper is used Adjust print position according to the
message displayed in Print Control
has errors Menu

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Appendix B Product Specifications

Product Name: Maternal/fetal integrated monitor

Product Model: T10, T12

Fetal Heart Rate

Probe: Multi-chip, wide beam, pulse operation mode and high sensitivity.

Ultrasound intensity: below 5mW/cm2

Operating frequency: 1.0MHz

Signal processing: dedicated digital signal processing unit

Measuring range: 50 ~ 210bpm

Alarm range:

Upper limit: 160, 170, 180, 190 bpm

Lower limit: 90, 100, 110, 120 bpm

Maximum audio output power: 1.5 Watts (W)

Uterine Contraction Pressure

Measuring range: 0 ～ 100 pressure units

Maternal blood oxygen saturation and measurement

Measurement range: 70%～99%.

Measurement accuracy: deviation ± 3%

Maternal pulse rate measurements

Measurement range: 30bpm ~ 240bpm.

Measurement accuracy: measurement deviation ±2 bpm.

Non-invasive blood pressure measurement

Measurement Range

a) systolic blood pressure 6.7 ~ 32.0kPa (50 ~ 240mmHg).

b) mean blood pressure 3.4 ~ 26.6kPa (25 ~ 200mmHg).

c) diastolic blood pressure 2.0 ~ 24.0ka (15 ~ 180mmHg).

Measurement range of pulse rate: 40bpm ~ 240bpm.

Accuracy of pulse rate measurement: ± 2 bpm; or ± 5% of the reading, both subject to whichever has

greater absolute value;

Measurement methods: manual start / stop NIBP measurement;

Display

LCD displays monitoring status, including fetal heart rate curve, uterine contraction pressure curve, fetal

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movement mark, doctor event mark, time, volume, etc. , and can freeze and play back.

Power: a.c.100-240V, 50 / 60Hz or 14.8V lithium battery

Environment

Working environment:

Temperature: + 5 ℃ ~ + 40 ℃

Humidity: 10% ~ 85%

Atmospheric pressure: 86kPa ~ 106kPa

Transport and storage environment:

Temperature: -10 ℃ ~ + 55 ℃

Humidity: 10% ~ 93%

Atmospheric pressure: 86kPa ~ 106kPa

Acoustic output of probe:

In accordance with the provisions of international conventions in 1992 IEC1157, negative peak of sound

pressure should not be more than 1 MPa (MPa), and intensity of sound beam should not exceed 20 mW / cm 2

(mW / cm2). Density of instantaneous-average sound intensity of spatial peak should not be more than 100

mW / cm 2. The sound intensity of this product does not exceed 5mW / cm2.

Coupling agent (GEL): viscous water-based compounds with no stimulus or allergy to the skin.

Chemically stable, bacteriostatic type.

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Appendix C Parameters and Alarm

C1.FHR (Fetal heat rate)

Measurement range: 50 ~ 210bpm

Alarm range: upper limit: 160, 170, 180, 190 bpm

lower limit: 90,100,110,120 bpm

Alarm delay: 15 seconds/30 seconds.

Alarm message: FHR 1 high or FHR 1 low or FHR 2 high or FHR 2 low

C2.NIBP noninvasive blood pressure

Measurement method: oscillametric method

Measurement parameters: systolic blood pressure, diastolic blood pressure, mean blood pressure, pulse

rate

Unit: mmHg or kPa

Measurement modes: manual, automatic

Measurement and alarm range (for adult):

Systolic blood pressure 6.7 ~ 32.0kPa (50 ~ 240mmHg).

Mean blood pressure 3.4 ~ 26.6kPa (25 ~ 200mmHg).

Diastolic blood pressure 2.0 ~ 24.0ka (15 ~ 180mmHg).

Measurement Accuracy: ± 1.1kPa (± 8mmHg) ; or ± 5% of the reading;

Alarm message: low systolic or high diastolic or low diastolic or high average or low average

C3.SPO2 blood oxygen

Measurement and alarm range: 70% to 99%.

Accuracy: deviation ± 3%

Sensor type: finger clip oxygen probe for adult

Alarm message: high oxygen values or low oxygen value

Measuring range of pulse rate: 30bpm ~ 240bpm.

Measurement accuracy of Pulse rate: ± 2 bpm, or ± 5% of the reading

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C4.ECG (electrocardiogram)

Measurement range of heart rate: 15 ~ 300bpm

Measurement error: ± 15%

Lead selection: Ⅰ, Ⅱ, Ⅲ, AVR, AVL, AVF, Ⅴ

Input: 3-lead or 5-lead ECG patient cable

C5.TEMP (temperature)

Range: 0～50C

Resolution ratio: 0.1C

Accuracy: 0.1C (excluding sensor error)

C6. Technical alarm

Alarm due to print door not closed well: Print door is not closed

Alarm due to out of paper: out of paper

Alarm due to monitoring time-up: Time is up

Alarm due to finger off: When the operator intentionally or unintentionally disconnects blood oxygen

finger probe, "oxygen probe off" message will appear, and sound alarm is given.

Alarm due to lead off: When the operator intentionally or unintentionally disconnect ECG lead wire,

message "ECG lead wire off" will appear.

C8. Alarm mute / pause

Press the icon( ) for a shorter time to enter mute alarm state until a new alarm event occurs;

Press the icon for a relatively long time to enter paused alarm state in which pause lasts up to

2min. During alarm pause, even if an alarm event occurs, no alarm is given.

[Special storage conditions and methods]

Transport: transport of the monitor should comply with the contract, but also should be kept
from being exposed to splashed rain/snow and mechanical collision.
Storage: the warehouse for keeping monitors should be dry. The monitors should be stored
inside the room with non-corrosive gases and good ventilation at the temperature ranging -10 ℃
~ + 55 ℃,and relative humidity ≤93%.The room should be kept from strong sunlight and other
gases causing corrosion, and should be well ventilated.

Appendix D Accessories

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Three-in-one probe
FHR probe
Uterine contraction pressure probe
Fetal movement mark button

FHR secondary probe: for twins

Fetal wake-up device

Blood oxygen finger cot

NIBP cuff

Insurance tube

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Power cord

ECG cable

Thermal printing paper

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