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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.
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.
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.
(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
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
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Manual for Maternal / Fetal Integrated Monitor
6.4 Disinfection...........................................................................................................................................33
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
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Manual for Maternal / Fetal Integrated Monitor
Chapter 1 Safety
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 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.
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
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.
Power on / off.
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)..
USB interface
Network Interface
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
● 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.
● Power cord
● Triad probe (ultrasound probe, uterine contraction pressure probe, fetal movement marker)
● 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
Fetal / maternal / multi-parameter patient monitors are classified into T10 and T12 models with the following
Function
six-parameter-interface, maternal-
fetal interface,
large-font interface
pressure(TOCO)
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.
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.
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.
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.
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
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 ℉
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
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
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.
Date/Time: Timely displays date and time of monitoring. When it is frozen, then starting date and time of
monitoring record will be displayed.
woman
pregnant women
(optional accessory)
Network Interface
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.
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 210 Position: Adjust the printing position for 210 of FHR
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.
Version 1.1 Page 25
Accessories
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.
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.
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.
Measurement interval: 03, 05, 10, 20, 30, 60, 90, 120, 240 (unit: min). Only when the measurement mode is
Hydrostatic Testing: Click this item back to the monitoring interface, and display area of blood pressure
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
Speed of blood oxygen waveform: the interface displays the speed of blood oxygen waveform. Three options
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,
ECG waveform speed: the interface displays the ECG waveform speed, three options including 6.25mm /
Experiment type: four options including NST, CS-NST, OCT and CST experiments are available.
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.
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.
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.
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
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.
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.
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
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.
Chapter 8 Printer
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.
8.3 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.
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.
■ Brief introduction
■ FHR setting
■ FHR monitoring
■ Common symptoms of fetal monitoring
■ cleaning & maintenance
Warning
Please use the accessories provided or recommended by the manufacturer.
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.
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.
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.
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 ℉).
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
Caution
Do not use a pressure cooker or bleaching agent containing sodium hypochlorite for disinfection of cables.
Pressure
■ Brief introduction
Externally measurement and record of the relative pressure changes are shown in the following
figure.
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
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.
Awakening of Fetus
■ Brief introduction
■ Monitoring of fetal movement
■ Awakening of fetus
awakening device:
Note
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.
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
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.
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.
■ Brief Introduction
■ NIBP measurement
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!
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.
※ 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.
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.
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.
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
■ Brief introduction
■ Precautions
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
result in inaccurate measurements. Possible interference source known: ambient light is too strong ,
patient movement.
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.
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.
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.
Warning
Make sure power is off or the power cord has been unplugged before cleaning the monitor and probe.
Caution
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.
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.
※ 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.
(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
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.
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.
■ Temperature monitoring
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.
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.
The quality and reliability of antepartum monitor are high. If you encounter any problems, please find
power switch is not turned on; power Check the power supply, power cord and
No display when boot
power switch
cut or poor power plug, poor sockets
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
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
Coupling agent (GEL): viscous water-based compounds with no stimulus or allergy to the skin.
Chemically stable, bacteriostatic type.
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: 0~50C
Resolution ratio: 0.1C
Accuracy: 0.1C (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
Three-in-one probe
FHR probe
Uterine contraction pressure probe
Fetal movement mark button
NIBP cuff
Insurance tube
Power cord
ECG cable