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Manual Inglês Mf9200

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MANUAL DE

INSTRUÇÕES

MONITOR FETAL
CARDIOTOCÓGRAFO

MF – 9200
Content
About User Manual
The information of this manual can be changed without prior notice.
Due to technical update or user special request, on the condition that not affecting fetal monitor performance
and specifications, some parts may be different with the standard configuration as listed on this manual.

Warn: User should know that how to avoid damage on patient and clinicians.
Caution: User should know that how to avoid damage on devices.
Note: User should know some important information.

IPX1closed instrument with water drop proof function.

Manufacture’s serial number.

Refer the files attached with this Fetal Monitor.

BF type applied part .

class II equipment .

Waste Electrical and Electronic Equipment Directive 2002/96/EC (WEEE Directive).

0482 Declaration of Conformity “The product complies with the requirements of the MDD

93/42/EEC”.

Fetal/Maternal Monitor User Manual Page 1 of 61


Content

Content
Chapter1. Preface.................................................................................................................................................. 4
1.1 Introduction ............................................................................................................................................ 4
1.2 Safety Guide ............................................................................................................................................ 4
1.3 It is needed to confirm fetal alive before using the monitor. .................................................................. 6
1.4 Intended Use ........................................................................................................................................... 6
Chapter2 Installation ............................................................................................................................................. 7
2.1 Unpacking and Checking ......................................................................................................................... 7
2.2 Power Supply........................................................................................................................................... 7
2.3 Starting Up .............................................................................................................................................. 8
2.4 Connecting the Probe ............................................................................................................................. 8
2.5 Checking the Printer................................................................................................................................ 8
Chapter3. Monitor Overview ................................................................................................................................ 9
3.1 Monitor Overview ................................................................................................................................... 9
3.2 Front View ............................................................................................................................................... 9
3.3 Operation and Functions of Keys .......................................................................................................... 10
3.4 External interface .................................................................................................................................. 11
Chapter4. Monitor Display Interface................................................................................................................... 12
4.1 Overview ............................................................................................................................................... 12
4.2 Description of Main Interface ............................................................................................................... 12
4.3 Setup Interface ...................................................................................................................................... 17
4.4 Backing Operation: ................................................................................................................................ 18
Chapter5. FHR Monitoring .................................................................................................................................. 19
5.1 Misidentifying MHR as FHR ................................................................................................................... 19
5.2 Introduction .......................................................................................................................................... 19
5.3 FHR Setting ............................................................................................................................................ 20
5.4 FHR Monitoring ..................................................................................................................................... 20
5.4.1 FHR Signal Acquisition Methods and Steps: ............................................................................... 20
5.4.2 Single Fetus Monitoring ............................................................................................................. 21
5.4.3 Twins Monitoring ....................................................................................................................... 21
5.5 Common Symptoms of Fetal Monitoring .............................................................................................. 21
5.6 Cleaning and Maintenance ................................................................................................................... 22
Chapter6. Uterine Contraction Pressure Monitoring .......................................................................................... 23
6.1 Introduction .......................................................................................................................................... 23
6.2 TOCO Settings........................................................................................................................................ 23
6.3 TOCO Monitoring .................................................................................................................................. 23
Chapter7. Fetal Movement Monitoring and Fetus Wake--up ............................................................................. 25
7.1 Introduction .......................................................................................................................................... 25
7.2 Fetal Movement Monitoring ................................................................................................................. 25
7.3 Fetus Wake-up ...................................................................................................................................... 26
Chapter8. NIBP Monitoring ................................................................................................................................. 28
8.1 Introduction .......................................................................................................................................... 28
8.2 NIBP Measurement ............................................................................................................................... 28
8.3 Cleaning and Maintenance ................................................................................................................... 30
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Content
8.4 Faults and Solutions .............................................................................................................................. 31
Chapter9. SpO2/Pulse Rate Monitoring .............................................................................................................. 32
9.1 Introduction .......................................................................................................................................... 32
9.2 SpO2 Monitoring.................................................................................................................................... 32
9.3 Precautions ........................................................................................................................................... 33
9.4 Factors Affecting the Reading................................................................................................................ 34
9.5 Cleaning and Maintenance ................................................................................................................... 34
9.6 Faults and Solutions .............................................................................................................................. 34
Chapter10. ECG/Respiration Monitoring ............................................................................................................ 36
10.1 ECG Monitoring Definition .................................................................................................................. 36
10.2 Precautions ......................................................................................................................................... 36
10.3 Monitoring Steps................................................................................................................................. 36
10.4 Respiration Monitoring ....................................................................................................................... 37
10.5 Maintenance and Cleaning ................................................................................................................. 38
Charpter11. Body Temperature Monitoring ....................................................................................................... 39
11.1 Temperature Monitoring ..................................................................................................................... 39
11.2 Maintenance and Cleaning ................................................................................................................. 39
Chapter12. Records review and Score ................................................................................................................ 40
12.1 Records list .......................................................................................................................................... 40
12.2 Data review ......................................................................................................................................... 40
12.3 Score.................................................................................................................................................... 41
12.4 Alarm ................................................................................................................................................... 43
Chapter 13. Printing ............................................................................................................................................ 44
13.1 Installing Printing Paper ...................................................................................................................... 44
13.2 Print Settings ....................................................................................................................................... 44
13.3 Print..................................................................................................................................................... 45
13.4 Cleaning the Printing Head ................................................................................................................. 45
Chapter 14. Alarm ............................................................................................................................................... 46
14.1 Alarm Category ................................................................................................................................... 46
14.2 Alarm Level.......................................................................................................................................... 46
14.3 Alarm Indication .................................................................................................................................. 47
14.4 Alarm pause and alarm Scilent(mute)/reset ....................................................................................... 47
14.5 Alarm Verification ............................................................................................................................... 48
Chapter 15. Networking ...................................................................................................................................... 49
15.1 wifi Setup ............................................................................................................................................ 49
15.2 Ethernet setup .................................................................................................................................... 49
15.3 System Setup ....................................................................................................................................... 49
Appendix 1: Troubleshooting .............................................................................................................................. 50
Appendix 2: Specifications .................................................................................................................................. 51
Appendix 3: Accessories ..................................................................................................................................... 53
Appendix 4: Symbols ........................................................................................................................................... 55
Appendix 5: Guidance and Manufacturer’s EMC Declaration ............................................................................ 56
Appendix 6: Table 201.103 Acoustic Output Reporing Table .............................................................................. 59

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Preface

Chapter1. Preface
 Introduction
 Safety Guide
 Recommended clinical application
1.1 Introduction

This Manual will describe the performance indicators, use and maintenance of the Fetal/Maternal
Monitor in details, and is intended for the personnel that are familiar with the parameters and have
experience in the use of the Monitor.
Before using this Monitor, please read the User’s Manual carefully in order to use the monitor properly,
make the device reach its performance indicators and use it in conformity with safety standards.
This User’s Manual is attached with the device. It should be placed near the Monitor for easy reference.
1.2 Safety Guide

MF-9200 is BF&CF applied device. It is portable fetal monitor.

indicates BF applied parts; indicates anti-Defib BF applied parts; indicates


anti-Defib CF applied parts.
BF protection indicates that patient connection should comply with the requirements of IEC60601-1 on
allowable leakage current and dielectric strength.
The waterproof rating of the ultrasonic probe is IPX1.
Before use it, please check its lifetime. Its lifetime is 5 years and manufacturing date is labeled at the
bottom side of device.
Instructions for Operation Safety
To avoid potential injury, be sure to abide by the following safety instructions while operating the
Monitor.
Warning: Do not rely solely on the alarm system of the Monitor when monitoring the patient. If the alarm
limit is set too low or alarm sound is turned off, it may hurt the patient. The most reliable method is
that the health care professionals closely monitor and properly use the Monitor. The alarm functions
of the Monitor must be periodically verified. When several devices are simultaneously used on the
same patient, the leakage current may be superposed. Before interconnection, it is recommended
that ask qualified professional to test the leakage current to ensure that the leakage current is in the
safe range, that is, won’t cause any harm to the patient, the operator and the surrounding
environment. If you still have questions, please consult the manufacturer for the correct use. Before
using this Monitor, the operator must verify that the Monitor is in proper working condition and
operating environment. Regularly check if the reusable accessories and the sensors are damaged, if
the cables are connected reliably, replace if necessary, and dispose the damaged accessories properly
as medical waste.
Warning: Do not use the instrument in the presence of flammable gases such as anesthetic agents, or it may
cause an explosion.
Warning: Don’t throw the battery into fire, or it may cause an explosion.
Warning: Don’t touch the signal input or signal output connectors and patient at the same time
Warning: The device can be used on one patient at one time.
Warning: To keep mother safe, please do not use other electronic device which connect with mother, such as
Fetal/Maternal Monitor User Manual Page 4 of 61
Preface
Pace Maker or other electronic stimulator.
Warning: This device is against Defibrillator. If Defibrillation is applied to mother, please take special
measurement.
Caution: This instrument must be maintained by qualified engineers.
Caution: This instrument is designed to work continuously, water drop proof type, pay attention to avoid to
be splashed.
Caution: Keep this instrument clean and avoid vibrating.
Caution: No high temperature disinfection, electron beam or γ-ray sterilization.
Caution: Electromagnetic interference – ensure the operating environment of the instrument away from
strong interference, such as wireless transmitters, mobile phones or other interference.
Caution: Before using the instrument, please check if there is any damage of equipment that may affect the
patient’s safe or the instrument performance. The recommended check period is every one month or
shorter. If an obvious damage is found, it should be solved before use.
Caution: The following safety check is done by the authorized person, normally one time per two years or
according to test regulation by the public organization.
 Check whether there are damages in the mechanical and functions.
 Check whether the relative safety label is easy to identify.
 Check whether the function is the same as described in the user manual.
Caution: After the effective life of this instrument, Please send it back to the manufacturer according to local
rules for recycling.
Caution: Disposal the battery properly according to local rules after the capability of battery run out.
Caution: If this instrument is not in use for a long period of time, remove the battery in time.
Caution: The battery should be stored in a cool and dry environment.
Caution: When store battery, please don’t mix it with metal objects to avoid short-circuit accident.
Caution: We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable. This
is considered to be good practice and should be observed at all times.
Caution: Don’t use this instrument immediately when it is transferred from a cold environment to a warm
and moisture place.
Caution: To ensure electric installation safety, the environment shall be reasonably dust free, without
corrosive or combustible gas, or extreme temperature or humidity.
Caution: Please stop operating if this instrument is splashed or has water drops.
Caution: Although the instrument is robust and designed to withstand the clinical use, the unit does contain
delicate components and should be treated with care. This applies especially to the transducers which
should not be dropped or knocked.
Caution: The use of water based gel supplied by certificated suppliers is strongly recommended. Oil based
gels can damage the transducer and must not be used. The use of oil based gels will invalidate your
warranty.
Caution: Excess gel should always be wiped off after use. The transducer faceplate, transducer body and
main unit can be cleaned with a damp cloth impregnated with a mild disinfectant or detergent.
Caution: A soft cloth dampened with sodium hypochlorite 1000ppm may be used for cleaning and
disinfection.
Caution: The main unit, transducers and other accessories can’t be disinfected by steam.
Caution: TOCO transducer is non-waterproof type, don’t use Gel and avoid any liquids into it.
Caution: The power wire should be inserted into the socket with three pins, the ground wire mustn’t be
removed. Don’t use the socket with bad connection.

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Preface
Caution: After use, do not wire the transducer cable together with the transducers to avoid damage.
Caution: Do not turn off the volume during monitoring, it is very important to monitor fetal heart sound.
Caution: The accuracy of FHR is decided by machine itself and cannot be adjusted. If you are suspicious of
accuracy of the result, you can verify it through other devices like a stethoscope, or you can contact
local distributors or manufacturers for help.

1.3 It is needed to confirm fetal alive before using the monitor.

Current technology cannot distinguish fetal heart rate (FHR) signal source from maternal heart rate (MHR)
signal sources in all circumstances. Therefore, before the monitoring, you must use a different method to
confirm that the fetus is still alive, such as palpation fetal movement, a Fetal stethoscope or a pinard. If you
can't hear the fetal heart sound, or fail to address the fetal movements, you will need to use the obstetric
ultrasound to confirm fetal survival, and confirm that the fetus is the guardianship of the signal source.

Should have known:


● MHR traces and FHR traces can be rendered extremely similar characteristics, as well as acceleration and
deceleration.
● Don't just rely on movement of the trace feature to identify sources of the fetal heart rate. There are only
traces of the fetus fetal movement on curve (FM) marks does not always guarantee that the fetus is still
alive. Deceased fetus also moves the body and lead to a mark of monitor fetal movements.
Here are a few examples, indicates how the MHR will be identified as FHR by error.
● When Ultrasonic transducer is used:
 you can pick up signals from the mother source, such as a mother's heart, aorta or great vessels of
other beats.
 When the MHR higher than normal (especially above 100bpm), it is possible to identify where the
error occurred.
● When enabling AFM curves (AFM):
the following may be causing fetal death and still appear in the context of FM tags:
 dead fetus in utero during exercise or after exercise.
 During and after manual palpation of fetal movements (especially if the pressure is too large), the dead
fetus will be moving.
 Movement of the ultrasonic transducer.
 Ultrasonic transducer detects the motion signal source, such as its main artery.
To reduce the possibility of confusion between MHR and FHR, also recommended that monitoring of
maternal and fetal heart rate simultaneously.
1.4 Intended Use

It is intended to be used to monitor Fetus Heart Rate, Fetal Movement, mother TOCO, and NIBP SPO2, PR,
ECG,HR, TEMP.
Contraditions: Do not use during Defibrillation, Electrosurgery, or Magnatic Resonance Imaging(MRI).

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Installation

Chapter2 Installation
 Unpacking and checking
 Power supply
 Starting up
 Connecting the probe
2.1 Unpacking and Checking

Unpack and take out the Monitor and accessories carefully, and keep the packing materials for future
transport or storage. Please check the Monitor, accessories and provided documents according to the
Packing List.
● Main unit
● Power cord and power adapter
● Three-in-one probe (ultrasonic probe U/S, uterine contraction probe TOCO and an event marker)
● Second ultrasonic probe (optional)
● Pulse Oximeter probe (SpO2), NIBP cuff &hose, ECG leadwire; TEMP probe
● Belt
● Printing paper
● Coupling Gel (optional)
● Certificate
● Warranty Card
● User Manual
● Packing List
 Check for any mechanical damage.
 Check all exposed wires and connect the accessories.
For installation, keep at least 2 inches (5 cm) space around the Monitor to ensure air circulation. The
environment for the Monitor should avoid vibration, dust, corrosive or explosive gases, extreme temperature
and moisture. If you have any questions, please contact our Sales Department or the dealer.
Note: If device get moist accidentally, please put in a well-ventilated environment for 24hours.
2.2 Power Supply

2.2.1 AC Power
To connect the AC power cord:
 Make sure the AC power supply meets the following specifications: AC 100-240V, 50/60Hz
Device keeps running after 30 seconds power-off.
[Note]Connect the power cord to the dedicated outlet in the hospital.
Quarterly checkup of the power adapter and power cord is needed. If any failure, please replace them. If
grounding does not work, please use battery.
Turn the power switch to “-”.
2.2.2 Battery Power
When the AC power is cut off, the Monitor will be powered by the built-in batteries. Before using, please
charge the batteries. When the Monitor is connected to AC power, the charging starts automatically, and
doesn’t require additional charger. To ensure the batteries are fully charged, we recommend that the users
connect this Monitor to an AC power source even when the Monitor isn’t used.

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Installation
The new fully charged batteries can maintain monitor work, while NIBP measurements and using the
printer will accelerate the power assumption. When the battery is running low, the battery symbol in the
upper right corner of the screen will flash, reminding the user to charge as soon as possible.
Warning:
Even if the instrument is not working, the batteries will gradually discharge. If the Monitor will be stored for
long-term, please keep the Monitor fully charged. Check the battery status at least once a month and
recharge.
It will take about 2.5hours from exhausted status to 90% of power.
2.3 Starting Up

2.3.1 Switch on
Press and hold the Power button for about 2 seconds to enter the starting up state, and the alarm LED
turns green. After 40 seconds of self tests, it goes to the main screen and ready for operating.
[Note]Check all available monitoring functions to ensure that the Monitor functions properly.
Warning:
If the monitor function has any signs of damage or an error message, do not use this Monitor, and contact
the biomedical engineer of the hospital or the service engineer of the company.
2.3.2 Switch off
Press and hold the Power button for about 2 seconds until it prompts: “Switch off”, Click “Yes” to switch off
the machine; Click “No” to cancel switch off.
2.4 Connecting the Probe

Connect the needed probe to the Monitor and correct place on patient.
[Note]For the correct connection of probes and related requirements, see Chapter 5-11.

2.5 Checking the Printer

Check if paper runs out after pressing “Printing button.”If no paper out, please check Chapter 13.

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Monitor Overview

Chapter3. Monitor Overview


 Monitor Overview
 Front View
 Operation and Functions of Keys
 External Interfaces
3.1 Monitor Overview

Environmental Requirements
Temperature
Operating: +5℃~+40℃
Transport and storage: -10℃~+55℃
Humidity
Operating: 30%~75%
Atmospheric pressure: 86kPa~106kPa
Transport and storage: <95%
Atmospheric pressure: 86kPa~106kPa
Power Requirements
Input: 100-240V, 50/60Hz,1.0A
Battery: 14.8V lithium battery
Do not use beyond the specified environmental requirements and power requirements, otherwise the
Monitor may not work properly.
This Monitor applies to the bedside monitoring of fetus, pregnant women and patients on ECG, noninvasive
blood pressure (NIBP), oxygen saturation (SpO2), respiration(RESP), body temperature(TEMP) and other
major life parameters. It integrates the parameter measurement, display and record output, compact,
lightweight and easy to use. Its high-resolution display interface can clearly show the waveforms and all
monitoring parameters.
3.2 Front View

The front panel of the Monitor is shown in Fig. 3-1.

Fig 3-1 Front View


①Power button ②Blood pressure measuring button ③Freeze button ④Volume- button
⑤ Volume+ button ⑥Print button ⑦UC Reset button ⑧Encoder disk ⑨Alarm indicator
⑩Display ⑪⑫⑬Probe holder ⑭ AC indicator ⑮Charging indicator ⑯Battery status indicator
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Monitor Overview

3.3 Operation and Functions of Keys

1. Power button
Press and hold this button for about 2 seconds to turn on the Monitor, and press and hold it again for 2
seconds to turn off the Monitor.
In monitoring state, press this button once to refresh the display interface and generate a number for the
pregnant women, and the fetal movement counting is reset.
2. Blood pressure measuring button
Press this button to activate the blood pressure measurement, and press this key blood while measuring
the blood pressure to stop the measurement.
3. Freeze button
Press this button once to freeze the system, and the main interface displays “Frozen”; press it again to
unfreeze and restore real-time scanning state.
4. VOL- button
In monitoring state, press this button in the main interface to turn down the speaker volume.
In freezing state, press this button to play the stored records reversely.
5. VOL+ button
In monitoring state, press this button in the main interface to turn up the speaker volume.
In freezing state, press this button to play the stored records forwardly.
6. Print button
After installing the printing paper, press this button to enter the real-time printing status, and press it
again to stop printing.
In freezing state, you can print the currently displayed monitoring records and press it again to stop
printing.
7. UC Reset button
Press this button once and the displayed pressure is reset to the set value.
During menu setting, press this button again to return to the monitoring screen.
8. Encoder disk
In monitoring state, rotate the encoder disk, press the encoder disk to confirm when the selected area
displays a blue frame, and then enter the appropriate settings.
In freezing state, rotate the encoder disk to turn pages of monitoring records.
9. Indicator
Under normal conditions, the indicator is green; in monitoring state, it flashes with the fetal heart rate;
when the heart rate is within the safe range, the indicator is green; when the heart rate exceeds the limit and
alarms, the indicator color depends on the alarm level.
10. Display
A 12.1-inch TFT display shows waveforms, menus, alarms and physiological measurement parameters.
11.12.13. Probe holder: used to hold the probe.
14. AC Indicator
When this indicator is green, the Monitor is connected to the.
15. Charging Indicator
When external power supply is connected, this indicator is orange, indicating that the batteries are being
charged; after charging is completed, the indicator goes out.
16.Battery status indicator
When this indicator is green, the Monitor is powered by internal batteries.

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Monitor Overview
3.4 External interface

Fig 3-2. Right panel Fig 3-3. Left panel

Fig 3-4. Rear panel grounding input

Port Introduction
FHR1: port of 3-in-1
FHR2: the second ultrasound transducer port when doing twin monitoring
SpO2: port of maternal SpO2 transducer
WAKER:Fetal acoustic stimulator (FAS) port (option)
ECG: ECG Leadwire port
TEMP: Maternal temperature probe port
NIBP : Maternal NIBP hose port , symbol indicates signal input is insulated and
against-Defibrllator
①:AC input socket
②:Power switch. Turn on or off the power. I: turn on; O: turn off.
NET: network port of central nurse station
USB: retained
RS232:retained

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Monitor Display Interface

Chapter4. Monitor Display Interface


 Overview
 Description of Main Interface
 Description of Menu Setup Interface
 Backing Operation
4.1 Overview

The Fetal/Maternal Monitor has models: three parameters/six parameters/nine parameters, the monitoring
functions of which are:
Interface Three Six Nine Three parameters Six parameters
Function parameters parameters parameters big font big font
Fetal heart rate(FHR) √ √ √ √ √
Uterine contraction √ √ √ √ √
pressure(TOCO)
Fetal Movement(FM) √ √ √ √ √
Pulse rate(MHR) / √ √ / √
Blood oxygen(SPO2) / √ √ / √
Blood pressure(NIBP) / √ √ / √
Electrocardiogram(ECG) / / √ / /
Respiration(RESP) / / √ / /
Body Temperature(TEMP) / / √ / /
Remark:√- Available;/- unavailable

4.2 Description of Main Interface

The display of the Fetus/Pregnant Women/Patient Multi-parameter Monitor is a 12.1-inch TFT screen,
which can display the information about pregnant women, parameter waveform and values, monitoring
status, alarm information, and other tips.
The Monitor has fetus interface and maternal-fetal interface, as shown in Figure 4-1 Fig 4-5.

Fig 4-1 3 Parameter Interface


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Monitor Display Interface

Fig 4-2 6 Parameter Interface

Fig 4-3 9 Parameter Big Font

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Monitor Display Interface

Fig 4-4 3 Parameter Big Font

Fig 4-5 6 Parameter Big Font


The monitoring interface has four sections:
①Wave area ②Numeric area ③Information area ④ Function button area
①Wave area
Three parameters interface: Waveforms from top to bottom are: FHR waveform (shown as two FHR
waveforms for twins, the interval between two waveforms is determined by the twin separation value
set by the system), uterine contraction pressure waveform, and fetal movement waveform (the user can
choose to display or close the waveform as required);

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Monitor Display Interface
Six parameters interface: Except above fetus interface waveform, NIBP, MHR, SpO2 are added;
Nine parameters interface: ECG, RESP, TEMP are added.
② Numeric area
1)FHR1/FHR2
Hear beat per minute ( Unit: times/min, bpm)

Alarm off indicator: Cross appeared after choose alarm off.

Speaker volume indicator: Level 0– Level 7, sound goes up from Level 0 to Level 7.

(20bpm) FHR 1 and FHR 2 offset. FHR 2 moves 20bpm down.

FHR signal strength indicator bar: bad, normal, good


2)Fetal Movement: Manual/Auto
Manual: Press FM marker to count FM times
Auto: Fetal monitor will auto count FM times by built-in algorithm.
3)TOCO ( 0-100): It is meaningless if waveform freeze.
(10) TOTO zeroing value, adjustable.
4)SpO2
5)Pulse Rate: Times/Min if SPO2 is configured, during SPO2 monitoring, PR will be on display.
6)NIBP: SYS/MAP/DIA (Unit: mmHg or KPa)

Auto monitoring time bar. If you choose auto monitoring, this is time bar. After goes full, device will start
up auto NIBP monitoring. 5 is time interval between every NIPB monitoring.
7) RESP (Unit: times/min)
8) TEMP (Unit: ℃ or ℉)

9) Monitored Time Length

User can setup parameters in Setup interface.


③ Information Area

It lies at top of display screen. From left to right, it display Mother Information, Alarm Information, Alarm
sound icon, Alarm pause icon, Bluetooth Icon, Printing Icon, Network icon, Power icon, Date/Time.
Mother Info: Display mother ID and name. After power on, device will automatically generate mother ID
based on Date and Time. This ID can be changed. After change, old ID corresponds to old monitoring data;
new ID only corresponds to newly monitoring data.
Alarm Info: Technical Alarm/Physiological Alarm. Left side display Technical Alarm; right side display
Physiological alarm.
Alarm sound: indicate sound volume is Level 1;
Alarm silence. During Alarm Silence, if new alarm event occur, it will activate alarming. Alarm silence is
ended.

Alarm Pause: Click to activate Alarm Pause countdown :2 minutes.


During alarm pause, if there is technical alarm, device will trigger alarm; alarm pause is ended.
During alarm pause, if there is physiological alarm, no alarm is triggered.
Bluetooth Icon: If probe type is “Bluetooth”, Bluetooth function will auto turn on.

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Monitor Display Interface

Bluetooth On; Bluetooth searching; Bluetooth connected; Bluetooth disconnected.

Printer: If printer works, display ; if printer does not work, display

Network: ---WiFi connection; ---Disconnected; ---Wired connection; not connect with Central

station; ---Connect with CMS; The Number after this icon is Bed No. Go to “Setup-System “to set up Bed
No.
Power: If connected with AC power, display ;If bars keep rolling, indicate power charging; If fully charged,

display , Device will automatically use AC power upon connected with external power supply.

Date/Time: Present Date and Time.


④ Button area (Touch operation)

: Press this button to enter the Mother Information interface. In this interface, you can type in or
modify the information.

After input mother information, press 【Monitoring】 to start monitoring; Click 【Finished】 to close this
interface without saving present setup. Click “OK ” to close this interface and saving setup.
【Monitoring】: Click this button, mother info input interface will prompt; after input mother information,
press this button to start monitoring, and the button will change into 【Finished】; Click 【Finished】 to stop
monitoring.

:Click this button, the volume of the fetal heart decreases

:Click this button, the volume of the fetal heart increases

: Press this button to preset TOCO calibration value.

: Press this button once to freeze the system, and the main interface displays “Frozen”; press it again to

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Monitor Display Interface
real-time scanning state.

: Press this button to find hidden functions.

: Press this button to activate NIBP measurement, and press again to stop the measurement.

: Click this button, enter Alarm pause state, the duration is 2min.

: Click this button to enter the alarm mute state.

Go to Record List

Click to change Interface

: Press this button to enter the Setup interface.

: Press this button to go back to the previous menu.

4.3 Setup Interface

4.3.1 Main menu:


Non-monitoring mode, Press ”More”---“Setup”, and enter the Setup interface.

Fig 4-6 Setup Interface


4.3.2 Setup
Parameters—Set up probe type, FHR, TOCO, Fetal Movement, NIBP, SPO2, PR

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Monitor Display Interface

Score--Fischer and Krebs


Print-- Set the printing parameters.
Volume-- Volume Level
Brightness--Set the brightness of the screen.
Language--Choose language
Date and time--- Set the system date and time. After setup, need to power off/on machine to save it.
WiFi--WiFi On/Off
Bluetooth--Bluetooth On/Off. Choose wireless probe, Bluetooth auto On; choose wired probe, Bluetooth auto
Off;
Ethernet—Wired network On/Off
System--Setup parameters, FHR Range, Mode, Bed Number, Central Station IP, Background color, Hospital
Name, and so on.
About-- Model No., Software version, resolution.
4.3.3. Setup Interface operation
Two ways:
4.3.3.1 One way: Using touch function, touch it to start setup
4.3.3.2 Rotate Knob + Volume up/ Volume down. For example:
FHR upper limit setup:
1) Rotate the knob to left side “Parameter”, press the knob, corresponding setup items will
display at right side;
2) Press Volume up, cursor move to right side;
3) Rotate the knob, cursor move to ”FHR-upper limit”, press Rotate Knob, return to Setup
Interface. Finish setup.
4) Rotate the knob, cursor move to setup to be chosen, press Rotate Knob and confirm, return
to Setup interface, finish setup

4.4 Backing Operation:

In the menu screen, select or to return to the monitoring interface.

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FHR Monitoring

Chapter5. FHR Monitoring


 Misidentifying MHR as FHR
 Introduction
 FHR Setting
 FHR Monitoring
 Common Symptoms of Fetal Monitoring
 Cleaning and Maintenance
5.1 Misidentifying MHR as FHR

It does not always mean that the fetus is still alive when the Monitor detects FHR. Before monitoring,
confirm that the fetus is still alive, and then confirm that the fetus is the source of recorded heart rate (see
1.3 Confirming the Fetus is Still Alive before Monitoring).
The following examples indicate how MHR is misidentified as FHR.
● When using an ultrasonic transducer:
△ The maternal signal source may be picked up, such as the beats of mother's heart, aorta or other large
vessels.
△ When MHR is higher than normal value (especially above 100bpm), misidentification may occur.
● When fetal movement curve (FM) is enabled:
Keep in mind that the only FM mark on the fetal trace does not always indicate that the fetus is still alive.
For example, the FM mark still appears when the fetus is dead under the following conditions:
△ Dead fetus moves during or after the mother moves.
△ Dead fetus moves during and after manual palpation of fetal movement (especially if the applied
pressure is too large).
△ Movement of the ultrasonic sensor.
5.2 Introduction

FHR monitoring is achieved basing on the Doppler Effect. We know that a certain frequency of ultrasonic
will be reflected when encountering obstacles in the transmission. If the object is stationary, the reflected
wave and the transmitted wave have the same frequency. Once the object moves, the reflecting frequency
will change. The reflecting frequency of the object facing the sound source becomes higher, and the reflecting
frequency of the object back to the sound source becomes lower. The faster the object moves, the greater the
frequency changes. This effect is called the Doppler Effect. Clinically, the ultrasonic sensor is used to emit
ultrasonic waves to human body, the echo signal changes when encountering organs in motion, such as the
heart, and the heart rate is derived by processing the echo signal.
Clinically, the best position for heart rate monitoring with Doppler is the fetus with its back toward the
mother’s abdomen. If the fetus is facing the abdomen, the hands and the feet will affect the echo, the fetal
turn makes the heart deviate from the irradiation area of the probe, the echo signal will decay, and some of
the Doppler components disappear.
Fetal heart probe position

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FHR Monitoring

Fig 5-1 Right Side panel


The FHR probe is connected to the FHR1 socket and FHR2 secondary probe socket in Fig. 5-1.
[Warning] Please use the accessories produced or recommended by the manufacturer.

5.3 FHR Setting

5.3.1Setup-Paramter-FHR
Offset (for twins): If monitoring twins, to avoid FHR2 waveform ovelap with FHR1 curve, lower the position of
FHR2 curve for several unit points, which are the curve separating values; available options are 0, 20, 30; 0
indicates no separation. Unit: bpm.
Sweeping speed: Adjust wave forms weeping speed.
Alarm switch: On- FHR out of range alarms; Off- FHR out of range, no alarm.
Alarm Level: high, medium and low.
Upper alarm limit: High limit of FHR alarm; options are 160, 170, 180, and 190 bpm.
Lower alarm limit: Low limit of FHR alarm; options are 90, 100, 110, and 120 bpm.
Alarm Delay: Trigger time; the time interval from FHR out--of--limit to alarm started; options are 15 seconds
and 30 seconds; Setup as On, an alarm sound generated when the trigger time is due.
Type Default Alarm Low Limit High Limit Default Alarm Range 围Step
Level
FHR Middle 90~120 160~190 110~160 10
5.3.2 Setup-Sound
FHR sound channel: FHR galloping sound channel, FHR 1/FHR2 alternative
FHR sound volume: FHR galloping sound level: 0 to 7 selectable
[Note]
The high limit of FHR alarm is usually set to 160bpm, and the lower limit is set to 110bpm.
Please set the alarm switch to ON, so clinicians can detect abnormal FHR on time.
5.4 FHR Monitoring

FHR measurement : place the ultrasonic probe on the abdomen of pregnant woman, the sensor will emit
low--energy ultrasonic signals to fetal heart and receive the echo signals from the fetal heart.

5.4.1 FHR Signal Acquisition Methods and Steps:


1) Find the position of strongest fetal heart with a stethoscope, or touch the fetal position and find the
optimal fetal position;
2) Coat coupling agent evenly on the acoustic surface of the ultrasonic probe;
3) Place the ultrasonic probe on the maternal fetal side, move slowly and listen to the fetal heart signal until
you find the clearest fetal heart signal;

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FHR Monitoring
4) Secure the ultrasonic probe with a bandage, and then adjust to make the signal is clear and the instrument
can accurately count; if the fetus is in head position, the best position is usually in the left or right below
the navel; if the fetus is in breech position, the best position may be above the womb;
5) Check if the FHR value displayed by the Monitor appears.
In the monitoring process, the Monitor always keeps the volume with fetal heart beat clearly audible. Do
not completely turn off the Monitor's sound;
6) When there is strong fetal movement, uterine contraction or body movement of pregnant woman, the
position of fetal heart may change greatly, and can’t hear clear fetal heart beats. In this case, adjust the
position of the ultrasonic probe to regain excellent fetal heart signals.
[Note] The monitoring records of the best quality can be obtained only when the probe is placed in the best
position.
[Warning] Do not turn off the speaker volume during monitoring. When the FHR signal is very weak (fetal
heart abnormal or fetal heart drifts to edges of probe detection zone) or there is no FHR signal (fetal heart
drifts out of the probe detection zone or stillbirth), and hear rhythmic fetal heart tones are barely heard
through the speaker, pay particular attention in this case. The FHR figure shown on the screen is meaningless.
5.4.2 Single Fetus Monitoring
Monitor one fetus. Identify the fetal heart position and tie the ultrasonic probe according to 5.4.1 FHR
Signal Acquisition Methods and Steps.
In the monitoring process, the Monitor will display the FHR value and corresponding curve. If the FHR is
greater than the upper alarm limit or lower than the lower alarm limit, the indicator on the front panel of the
Monitor will change the color and flash according to the alarm levels. If the time of FHR out--of--limit exceeds
the preset alarm delay, the system will alarm if the alarm is enabled, the top of the screen has prompt; if the
alarm is disabled, alarm prompt and alarm icon will not appear.
5.4.3 Twins Monitoring
Monitor twins. Identify the fetal heart position and tie the master and secondary ultrasonic probes according
to 5.4.1 FHR Signal Acquisition Methods and Steps. In order to observe two FHR curves clearly, it is
recommended to set the separation value of twins curve (i.e. a value other than 0).
Identify the sound output from the master probe (FHR1) or the secondary probe (FHR2) by setting fetal heart
tone channel.
In the monitoring process, the Monitor will display two FHR values and corresponding curves. To monitor
single fetus with twins monitor, please select FHR1 as the fetal tone channel, otherwise you can’t hear the
fetal heart tone.
5.5 Common Symptoms of Fetal Monitoring

The normal range of FHR baseline is 110~160 beats / minute (BPM), and baseline changes are those
changes over 15 minutes.
(1) Fetal tachycardia:
The heart rate baseline exceeds 160BPM, and factors in relation to or resulting in tachycardia include: fetal
hypoxia, maternal fever, maternal hyperthyroidism, anemia in the fetus, amnionitis; fetal tachycardia is
usually accompanied by heart rate variability disappearing.
(2) Fetal bradycardia:
The heart rate baseline is lower than 110BPM.
(3) Heart rate variability:
Heart rate variability is an important feature to estimate fetal status at any given time. It reflects the

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FHR Monitoring
integrity of the neural regulation system and cardiovascular systems of the fetal heart, including short--term
and long--term variability.
Short--term variability is the irregularity between heartbeats, and is caused by the error of normal cardiac
electrical activity cycle.
Long--term variability is the fluctuations of heart rate curve.
Acceleration is the periodic heart rate changes above FHR baseline, and relates to fetal movement and
uterine contractions.
Deceleration is the periodic heart rate changes below FHR baseline. Unlike the baseline change, the
duration of deceleration is relatively short, usually less than 10 minutes. According to the shape and the
relation with uterine contraction cycle, it can be divided into the following three types:
① Early deceleration: The obvious feature is that FHR begins to decline before uterine contractions and
returns to the baseline after uterine contractions. It is generally related to the pressure on fetal brain.
② Late deceleration: The obvious feature is that FHR begins to decline when uterine contraction begins,
and returns to the baseline after uterine contractions. It is generally caused by fetal hypoxia.
③ Variable deceleration: The shape, start time and duration of FHR curve are not the same. It is the most
common during childbirth, and is usually caused by umbilical cord compression.
5.6 Cleaning and Maintenance

Caution:
If possible, always comply with the specific instructions supplied with the probe. These data may be newer
than the information provided in this Manual. The information provided in this chapter is intended to be
general cleaning guidelines when you can’t get the special cleaning methods of certain products.
If there is any deterioration or damage, please replace the cable. In this case, do not use this cable for
patient monitoring.
5.6.1 Cleaning the Probe Cable
In order to maintain cable dust--free, clean it with a piece of lint--free cloth soaked in warm soapy water (≤
40°C/104°F), diluted non--corrosive detergent or one of the following approved cleaning agents.
Recommended cleaning agents and trademarks:
Alcohol--ethanol 70%
5.6.2 Cable Sterilization
In order to avoid causing long--term damage to the cable, we recommend sterilizing the cable only when it
is deemed necessary according to the hospital procedure. We recommend cleaning first.
Recommended sterilization materials:
Alcohol--ethanol 70%
Caution:
Do not sterilize the cable with a pressure cooker or bleach containing sodium hypochlorite.

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Uterine Contraction Pressure Monitoring

Chapter6. Uterine Contraction Pressure Monitoring


 Introduction
 UC Settings
 UC Pressure Monitoring

UC Reset mark:

6.1 Introduction

Uterine contraction pressure monitoring is to measure uterine activities by placing a TOCO transducer on
the abdomen of pregnant woman.
Measure and record the relative pressure changes, as shown below.

Fig. 6--1 Uterine Contraction Pressure Monitoring Diagram

UC pressure monitoring is to monitor the uterine contractions. UC pressure is the indicator of childbirth
strength. Clinically, the uterine contraction has directly affected the fetal heart rate activities and childbirth.
The curves recorded by pressure monitoring can provide a lot of information, such as the intensity, frequency
and duration of uterine contraction, regularity and shape; the uterine contraction may cause FHR increased or
reduced. At present, the FHR monitoring is accompanied by UC pressure monitoring, and the medical
personnel can combine UC situation and FHR changes for diagnosis.
External pressure monitoring is to obtain UC pressure from the maternal abdomen. When a contraction
occurs, the compression of the abdominal wall tension is applied on the pressure sensor, which will convert
the pressure into electric signals. The resulting pressure signals are amplified and processed through the
instrument, and finally output or printed.
6.2 TOCO Settings

Setting options for TOCO pressure monitoring:


TOCO Reset: Select the TOCO Reset value from 0, 5, 10, 15, and 20.
Display the contraction strength basing on selected value.
6.3 TOCO Monitoring

1. Connect the probe


Place the TOCO probe on mother’s abdomen and fix with strap.
Warning:
Do not monitor patients underwater.
2. Collecting TOCO Data
The strap should have moderate elasticity. If it is too tight, the peak of uterine contraction may be flat
topped and lower than 100 on the pressure gauge. If it is too loose, the probe may slip, causing abnormal

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Uterine Contraction Pressure Monitoring
readings. Adjust the strap pressure as required.
[Note]:
Do not use ultrasonic coupling agent on the UC probe or probe contact area.
3. Monitor Adjustment
Press the UC Reset button on the front panel to adjust the pressure to the reset value. Press the UC Reset
button once, the main interface will show a UC reset mark, and only one press is valid if the UC Reset button
is pressed repeatedly within 5 seconds.
[Note]:
Pressure adjustment must be carried out between two uterine contractions.

Fetal/Maternal Monitor User Manual Page 24 of 61


Fetal Movement Monitoring and Fetus Wake--up

Chapter7. Fetal Movement Monitoring and Fetus Wake--up


 Introduction
 Fetal Movement Monitoring
 Fetal Wake--up

Automatic fetal movement mark: ; manual fetal movement mark: ; wake--up device mark:

7.1 Introduction

The activities of the fetus in the uterus is called fetal movement, which are shown as fetal limb movement,
swing, fetal head and body rotating, turning and rolling. Fetal movement is the movement signals sent by
fetus to its mother, and an objective sign of fetal life. Presence or absence of fetal movement is directly
related to fetal safety, and the state of fetal movement is also an important indicator used by obstetricians to
observe the fetus. Therefore, both pregnant women and obstetrician must know the fetal movement timely.
Fetal movement monitoring includes automatic and manual monitoring. Automatic fetal movement
monitoring is to convert the fetal movement signal into electrical signals through the sensor, amplify and
process through the instrument, and then automatically record the fetal movement information obtained by
the instrument. Manual fetal movement monitoring is that the pregnant woman uses the relevant accessories
to mark fetal movement information according to the fetal movement during monitoring.

7.2 Fetal Movement Monitoring

This Monitor features automatic and manual fetal movement monitoring.


Fetal movement intensity curve: Display or close fetal movement curve on the interface. Fetal movement
curve is a uterine contraction curve shown in TOCO area, indicating the dynamic information of fetal
movement; select “ON” to display the fetal curve, or select “OFF” to hide.
Fetal movement counting mode: “Manual” and “Auto” are available; select “Auto”, and the display shows
“Automatic fetal movement” on the right of the fetal movement area; select “Manual”, and the display shows
“Manual fetal movement” on the right of the fetal movement area. About the “Automatic fetal movement”
and “Manual fetal movement”, refer to the description of fetal movement in Chapter 7.
Fetal movement counting threshold: Threshold of automatic fetal movement, adjustable from 10% to 80%;
fetal movement threshold indicates the percentage of fetal movement intensity; if 10% is selected, a minor
fetal change is counted as a fetal movement; if 80% is selected, only strong fetal movement will be counted; it
is recommended to set to 40%~60%. If the ‘fetal movement counting’ is set to ‘Auto’, i.e. automatic fetal
movement, the setting is effective.
If the fetal movement counting is ‘Auto’, the Monitor will determine if fetal movement occurs according to

the fetal movement threshold; if yes, it marks once , and the number of fetal movement increases by one.

If the fetal movement counting is ‘Manual’, the pregnant woman shall hold the fetal movement event
marker, press the button in the top of the fetal movement event marker when feeling fetal movement; the

interface displays the mark , and the number of fetal movement increases by one.
[Note]:
The measurement results of automatic fetal movement monitoring may be related to the following factors:
fetal movement, maternal body movement, and other external interference. Therefore, please reduce the
Fetal/Maternal Monitor User Manual Page 25 of 61
Fetal Movement Monitoring and Fetus Wake--up
external interference (touching pregnant woman, move monitoring bed, etc.) in monitoring, and the pregnant
woman should keep quiet, so that accurate results of automatic fetal movement monitoring can be obtained.
7.3 Fetus Wake-up

Fetus wake--up is to use the fetus wake--up device to give the fetus a certain amount of stimulation and
wake up the sleeping fetus. Fetus wake--up mainly applies non--stress test (NST), which can avoid
misjudgment of NST results by obstetrician. NST is to observe and record fetal heart rate and uterine
contraction curve without uterine contraction or other external stress; it is an ideal method to determine the
function of fetal placenta.
7.3.1 Fetal Wake-up Device

Fig.7-1 Wake-up Device and Connecting Cable


① Power switch
Press this switch and the instrument begins operation; press it again to stop operation.
There are two modes of operation: continuous mode that operates when the switch is pressed and
three-time mode that operates three times and stops in any condition.
② Mode selector switch
Continuous mode and 3-sec mode are optional.
③ FAST, SLOW knob
Adjust vibration rhythm during operation (intermittent repetition period).
④ Battery holder
Use two alkaline batteries.
⑤ Vibrating head
Vibrating surface
⑥ Marker socket
Connect to the fetal monitor, and a message appears automatically when the vibration sound pulse occurs.
7.3.2 Preparation for Operation
(1) Turn on the fetus wake--up device, and check if the device works properly. Do not use if there is any
problem;
Before using, load the batteries and close the battery compartment cover in the steps as follows:
Remove the battery compartment cover Insert a coin, tweezers or similar flat object in the position
indicated by the arrow in the lower left to remove the battery compartment cover, and press down the
battery compartment in the arrow direction (Fig. 7-2)

Fig. 7-2 Removing the Battery Cover


Load the batteries Load two alkaline batteries into the battery compartment according to the polarity

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Fetal Movement Monitoring and Fetus Wake--up
indication on the battery compartment (battery anode and cathode matching the anode and cathode on the
battery compartment) and close the battery cover, as shown in Fig. 8--3.

Fig. 7-3 Loading the Batteries


Remove the batteries Press down the cathode Θ of the batteries with a finger to remove the batteries.

Caution: If the instrument won’t be used for a long time, take out the batteries.
[Note]
① Do not mix old and new batteries or different types of batteries together;
② Do not disassemble the batteries to avoid battery leakage or rupture
(2) Connect the fetus wake--up device to the interface in the rear of the fetal monitor. Connection example is
shown below:

(3) Press the Mode button to switch the wake--up device between three--time mode (stop automatically after
vibrating three times) and continuous mode.
7.3.3 Waking up the Fetus
Place the vibrating head of the instrument on the mother’s abdomen, press the vibration switch, and release
to stop vibrating. Under normal circumstances, the vibration can awaken the fetus. When the fetus wake--up
device is started, the main interface will show a mark of fetus wake-up device.

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NIBP Monitoring

Chapter8. NIBP Monitoring


 Introduction
 NIBP Measurement
 Cleaning and Maintenance
8.1 Introduction

Blood pressure is the force that the heart pinches off the blood and the pressure on vessel wall when blood
flows. It is an important physiological parameter reflecting the function of human circulatory system, and has
very important significance to blood pressure monitoring in clinical practice.
Blood pressure can be measured after converted to electrical signals by blood pressure transducer. The
measurement methods include direct and indirect. Direct measurement is accurate, and can track the
instantaneous change in arterial blood pressure, but it is invasive because the catheter must be put into the
blood vessel percutaneously, and are generally used for critically ill patients or patients require surgery.
Indirect method is simple and noninvasive, causes small perturbations to human body, and is widely used in
clinical measurements. Indirect methods include auscultation, ultrasonic, oscillation and double--cuff. Our
products use the oscillation method, which is used by most foreign non--invasive blood pressure monitors.
Oscillometric method is also known as vibrometer method or oscilloscope method. Oscillometric method
still uses inflatable cuff to block arterial blood flow. Due to the pulsation of arterial blood flow, air pressure
batteries generated by arterial blood flow can be detected in the cuff. First, the cuff is inflated to 20mmHg
higher than the systolic blood pressure, then the cuff slowly deflates; when the pressure in the cuff is higher
than systolic blood pressure, the arteries are blocked; due to proximal blood pulsation, oscillatory wave with
smaller amplitude occurs. When the pressure in the cuff is equal to systolic pressure, the amplitude of the
oscillatory wave increases; with continuous decrease of the pressure in the cuff, the amplitude of the
oscillatory wave increases; when the pressure in the cuff reaches a certain value, the amplitude reaches the
maximum, and the pressure in the cuff is mean arterial pressure. The oscillometric method is to identify
arterial mean pressure based on the variation of amplitude of oscillatory wave under different cuff pressure,
and then obtain the arterial systolic and diastolic blood pressure with the mean pressure.
8.2 NIBP Measurement

Noninvasive Blood Pressure (NIBP) measurement uses oscillometric method.


Auto mode: On/Off Auto NIBP measurement mode
Time interval: time interval can be set to 3, 5, 10, 20, 30, 60, 90, 120, and 240min.
Unit: kPa or mmHg
Manometer Test: Click this option to return to the monitoring interface, and the blood pressure value display
area prompts: Hydrostatic testing.
Air Leak Test: Click this option to return to the monitoring interface, and the blood pressure value display area
prompts: Air leakage testing
Alarm switch: ON/Off to enable or disable out-of-limit range alarm.
Alarm levels: Alarm priority: high, medium and low.
Upper alarm limit: High limit of NIBP alarm.
Lower alarm limit: Lower limit of NIBP alarm.
Type Default alarm levels Lower alarm limit Upper alarm limit Default Alarm Step
Range

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NIBP Monitoring
NIBP(mmHg)
SBP medium 30~(Upper Limit-1) (Low limit+1)~250 90~160 1
DBP medium 30~(Upper Limit-1) (Low limit+1)~250 50~90 1
MAP medium 30~(Upper Limite-1) (Low limit+1)~250 60~110 1

[Note]
1) Non-invasive blood pressure measurement isn‘t allowed for the patients with sickle cell disease and skin
damage or any expected damage.
2) For patients with severe coagulation disorder, determine if the automatic blood pressure measurement
should be taken according to the clinical evaluation, because the friction between the body and the cuff
may produce hematoma.
3) NIBP monitoring is easily affected by patients posture and physiological condition. NIBP result will be
affected under following circumstances:
※ Patients are moving or shivering
※There are dramatic pressure changes within short time
※Patient is in shock state or is with extreme low temperature.
4) Arrhythmia will extend NIBP monitoring time.

[Caution]
SPO2 monitoring and NIBP monitoring should not be used on same limb.
[Caution]
There is big NIBP readings deviation if patient has epilepsy occurring or shivering.
[Caution]
Do not repetitively monitor NIBP on single patients for long time.
[Warning]
Do not install cuff on a limb with intravenous infusion or catheter. During inflating the cuff, if the infusion is
slowed or blocked, it may cause injury around the catheter.
The inflatable tube connecting blood pressure cuff and the Monitor should smooth.
8.2.1 Measuring Method:
1. Connect NIBP cuff with the fetal monitor, turn on the instrument.
2. In accordance with the following method, tie blood pressure cuff on the arm or the thigh of the patient
(Fig. 8--1).
※ Confirm the cuff is completely deflated.
※ Use the cuff of appropriate size for patients to ensure that the symbol φ is located just above the
appropriate artery. Make sure that the cuff around limbs is not too tight, or else it may cause distal
discoloration or ischemia.

Fig. 8-1 Using Cuff


[Note]
Adult cuffs can never be used on neonate. Cuff width should be 40% of limb circumference (50% of

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NIBP Monitoring
newborns), or 2/3 of the upper arm length. The length of the inflated part of the cuff should be sufficient for
50 to 80% around the limb, because the wrong size cuff will produce erroneous readings. If there is any
problem with the cuff size, use a bigger cuff to reduce errors.
When measuring in the newborn mode, the maximum possible pressure in the cuff is 147mmHg, the
maximum pressure in normal use is 140mmHg, and the initial inflation pressure is 70mmHg.
3. Connect the cuff and inflation tube. The body part for pressure measurement should be in the same
horizontal position with the patient's heart. If it is impossible, correct the measurement results in the
following method:
※If the cuff is above the heart level position, the gap per centimeter should be the displayed value plus
0.75mmHg (0.10kPa).
※ If the cuff is below the heart level position, the gap per centimeter should be the displayed value less
0.75mmHg (0.10kPa).
4. Select the measurement mode: if ‘Auto’ is selected, the time interval should be selected; see the
following ‘Operation Tips’ for specific methods.
5. Press the blood pressure measurement button on the front panel to inflate and measure the pressure.
8.2.2 Operation Tips
1. Automatic measurement
Set the ‘Auto measuring mode’ to ‘on’, and start the automatic measurement.
2. Manual measurement
Set the ‘Auto measuring mode’ to ‘off’, and then press the blood pressure measurement button on the
front panel to start a manual measurement.
[Warning]:
The noninvasive measurement time of automatic mode is too long, and the limbs friction with cuff may be
accompanied by purpura, ischemia, and nerve damage. During patient monitoring, the distal color, warmth
and sensitivity should be checked. Once there are any abnormalities, put the cuff in another place or stop
blood pressure measurement immediately.
[Warning]
Do not over inflate the cuff. Otherwise it will shorten cuff lifetime and affect monitoring accuracy and
brings discomfort to patient.
[Statement]
The device detects NIBP based on Oscillometric method, which is equal to Auscultatory method, the
tolerance accords with the YY0667-2008 requirements. When you doubt the test results, you can verify
according to Auscultatory method.
8.3 Cleaning and Maintenance

[Warning]
※Do not squeeze the hose on the cuff.
※Do not allow water or cleaning fluid flowing into the connector socket of the Monitor to prevent damage to
the instrument.
※When cleaning the Monitor, only wipe the outer of the coupling socket, and do not wipe its interior.
The cuff can be reused, sterilized by conventional hot air oven, disinfected by gas or radiation sterilization
method, or immersed in decontamination solution for sterilization. But keep in mind that the rubber bag
should be removed to use this method. Cuff can‘t be dry--cleaned. It can be machine washed or hand washed,
and hand wash can extend the useful life. Before cleaning, remove the rubber bag. When the cuff is dry,

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NIBP Monitoring
reload the rubber bag, as shown in Fig. 8-2 and Fig. 8-3.

Fig. 8-2 Replacing Rubber Bags in the Cuff Fig. 8-3 Replacing Rubber Bags in the Cuff
8.4 Faults and Solutions

8.4.1 NIBP readings has big deviation


Possible reasons: NIBP cuff air leakage
Patient has big movement during NIBP monitoring.
Interval time between two monitoring is too short.
Solutions: Change NIBP cuff or connector
Do not talk or move during monitoring, do not touch cuff.
Wait for some time before going on another NIBP monitoring.

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SpO2/Pulse Rate Monitoring

Chapter9. SpO2/Pulse Rate Monitoring


 Introduction
 SpO2 Monitoring
 Precautions
 Factors Affecting the Reading
 Cleaning and Maintenance
 Troubleshooting
9.1 Introduction

SpO2 parameter measures arterial oxygen saturation, which is the percentage of oxygenated hemoglobin in
the sum of oxygenated hemoglobin and deoxygenated hemoglobin.
Oxygen monitoring uses optical technology, which can measure the arterial SpO2 saturation continuously
without taking blood. The conventional oxygen probe of the Monitor is a finger probe, which is put on the
finger for use. The upper wall of the probe fixes two juxtaposed light emitting diodes (LED), which emit
660nm wavelength red light and 890nm wavelength infrared light. The lower wall has a photodetector, which
convert the red light and the infrared light transmitted through the finger artery into electric signals. The
pulse of optical signals is same to the heart beat, so that the repetition period of the signal is detected, and
the pulse rate is determined.
Caution:
Deal with sensors and cables carefully. The sensors have sensitive electronic components inside, which will
be damaged due to rough treatment. Protect the cables from contact with sharp objects. The wear due to
patient movement and normal sensor cleaning means that SpO2 sensor life is limited.
Our guarantee does not apply to damage caused by incorrect use.
Warning:
During MRI, applying SpO2 sensor can cause severe burns. To minimize this risk, ensure that the location of
the cable will not form induction loops. If the sensor can‘t work correctly, take it away from the patient
immediately.
Do not attach SpO2 sensor in the ambient temperature over 37°C, as long attachment will cause severe
burns.
Caution:
Injected dyes such as methylene blue, or intravascular staining hemoglobin, such as methemoglobin, may
result in inaccurate measurements.
Known possible sources of interference include strong ambient light and patient movement.
9.2 SpO2 Monitoring

9.2.1 SpO2 Probe


Adult finger probe, reusable
Insert the patient's finger into the probe, and ensure that the probe completely encases the finger.
9.2.2 Settings
Alarm switch: Whether enable fetal parameter out--of--limit alarm; ON ------ Enable; OFF ------Disable.
Alarm levels: Alarm priority: high, medium and low.
Upper alarm limit: High limit of parameters alarm.
Lower alarm limit: Lower limit of parameters alarm.

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SpO2/Pulse Rate Monitoring

Type Default alarm levels Lower alarm limit Upper alarm limit Default Alarm Range Step
SpO2 medium 0~ (High limit -1) (Low limit +1)~100 90~100 1
Pulse medium 0~(High limit -1) (Low limit +1)~240 50~120 1
Rate

9.2.3 Monitoring Steps:


1) Turn on the Monitor;
2) Attach the sensor to the finger of the patient in the appropriate place;
3) Plug one end of the sensor cable into SpO2 hole of SpO2 module.

Fig. 9-1 Placement of Oximetry Finger Cot


Warning:
Do not put the probe on the limbs with arterial duct or intravenous injection tube.
Make sure that the light emitter and the light detector are opposite to each other, and all of the light
emitted passes through the patient‘s tissue.
[Note]
Confirm that pulsating blood flow exists at the attaching position.
Confirm that the attaching position has no vibration or excessive movement.
Confirm that the skin at the attaching position is neither too thick nor too thin.
Applying the probe in strong light may lead to inaccurate measurement results; please cover the attaching
position with opaque material.
Keep the power cable away from the probe cable.
Warning:
Continuous monitoring for too long may cause skin redness, blistering or pressure necrosis. Therefore,
regularly check the attaching position of the probe, and change the placement of the probe if the skin
quality declines; for special status of particular patient, more frequent inspections may be required.
9.3 Precautions

Warning:
Check the attaching position every 2 to 3 hours to ensure the skin quality and the correct position of optical
measurement. If skin quality changes, move the probe to another position. Avoid affecting the accuracy of
measurement caused by movement and other factors.
[Note]
Clean the surface of the oxygen probe with 70% ethanol solution before and after each use, but do not
completely immerse the probe in the solution.
If the package or the oxygen sensor probe is damaged, do not use.
Do not sterilize the SpO2 probe by radiation, steam or ethylene oxide.
Be careful when connecting cables to avoid entangled in the patient.
If the test position and the probe can‘t be accurately located, the oxygen readings may be inaccurate, and

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SpO2/Pulse Rate Monitoring
relocation is required.
9.4 Factors Affecting the Reading

1) Nail polish, especially the purple and blue; the reading will be reduced by the same absorption; it is
recommended washing the nail polish before measuring.
2) Fake nails prevent the detection from penetrating the tissue, thus affecting the measurement of oxygen
values.
3) SPO2 value of the patient is too low.
4) Excessive smokers have high instantaneous CO level, resulting in higher SPO2 readings.
5) Injected dye or intravascular dyeing hemoglobin.
6) Known potential sources of interference: strong ambient light, patient movement.
7) Sensor is placed incorrectly or an improper sensor is used.
8) Poor perfusion of the measured position.
9) When the Hb--CO, Met--Hb or chemical agent is present, SPO2 value may be high.
10) Vein has rhythmic vibration.
11) Severe disorders in haemochrome function (such as hemoglobin and ferritin).
9.5 Cleaning and Maintenance

Warning:
Before cleaning the monitor and the probe, make sure the power has been off or the power cord is
unplugged.
Caution:
Do not disinfect the sensor in autoclave.
9.5.1 Cleaning the Probe
1) Clean the sensor appearance with mild detergent solution or salt solution (1%).
2) Scrub the sensor's appearance with dry cloth, and let it dry.
3) Wipe the emitting and receiving parts of the sensor with soft cloth moistened with detergent or medical
alcohol, then wipe with dry cloth.
4) Check the sensor and cable, and do not use if there is any sign of deterioration or damage.
9.5.2 Cleaning the Cable
Clean the cable in the following method:
1) Please wipe the outer surface of the cable with antibacterial soap water or 70% alcohol; be careful to
avoid liquids entering the cable connections.
2) Wipe with clean dry cloth.
Warning:
Do not soak the probe in any liquid or let any liquid enter into electrical connections.
9.6 Faults and Solutions

9.6.1 No SpO2 values


Failure:
In the monitoring process, there are no SpO2 waveforms and values.
Inspection method:
Check if the finger probe flashes red, if the arm of examinee is oppressed, and if the temperature in the
monitoring room is too low.

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SpO2/Pulse Rate Monitoring
Solutions:
If the finger probe doesn‘t flash red light, the wire interface contact may be poor; please check the
extension cord and socket interface. In cold areas, do not expose the patient's arm to avoid affecting the
testing effect. Do not measure the blood pressure and the SpO2 on the same arm, in order to avoid affecting
the measurement.
If the SpO2 channel waveform isn‘t displayed, the SpO2 module and master unit have communication
problem; please turn off the unit and turn it on again; if there is still such prompt, please contact the
biomedical engineer of the hospital or your supplier.
9.6.2 Intermittent SpO2 values
Failure:
The SpO2 values appear intermittently when measuring the body oxygen saturation.
Inspection method:
1) During long--term monitoring and surgery, the patient has severe vibration or movement, resulting in
intermittent SpO2 values.
2) Check the SpO2 extension cord.
Solution:
Keep the patient stable; once the SpO2 value is missing due to hand movements, it is considered normal. If
the SpO2 extension cord is damaged, replace it.

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ECG/Respiration Monitoring

Chapter10. ECG/Respiration Monitoring


 ECG Monitoring Definition
 Precautions
 Monitoring Steps
 Respiration Monitoring
 Maintenance and Cleaning
10.1 ECG Monitoring Definition

ECG monitoring generates continuous waveform of patient’s cardiac electrical activities to accurately assess
the physiological state of the patient. In order to obtain the correct measurements, appropriately prepare
patient's skin, accurately place the electrodes and properly connect ECG cables. During normal display, a line
of ECG waveform can be displayed.
※ Patient cable consists of two parts:
Main cable connecting to the Monitor;
Lead connecting to the patient.
※The instrument is configured with five-lead wire.
10.2 Precautions

Warning
When you connect the electrodes or patient cable, assure that it is not connected to any other conductive
parts or the ground. In particular, make sure that all the ECG electrodes, including the neutral electrodes, are
attached to the patient in order to prevent them from contact with the conductive member or ground.
[Note]
Do not use equipment with electric radiation near ECG / respiration measurement.
10.3 Monitoring Steps

10.3.1 Set-up
Set-up—》Parameters—》ECG
Defibrillator on-off button: Turn-on----the symbol of defibrillator will appear; Turn-off-----the symbol of
defibrillator won’t appear
Lead type: 3 or 5 leads is optional
Main Leads: I、II、III、aVR、aVL、aVF、V-
Waveform gain: ECG waveform gain 0.25X、0.5X、1X、2X、4X
Waveform speed: ECG waveform shows 6.25mm/s、12.5mm/s、25mm/s
Alarm switch: Whether enable fetal parameter out--of--limit alarm; ON ------ Enable; OFF ------Disable.
Alarm levels: Alarm priority: high, medium and low.
Upper alarm limit: High limit of parameters alarm.
Lower alarm limit: Lower limit of parameters alarm.
10.3.2 Preparation
1) Prepare patient skin before placing the electrodes.
※Skin is a poor conductor; to get a good contact between electrodes and the skin, it is very important to
prepare the patient's skin.
※ If necessary, shave body hair at the position that the electrode is placed.

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ECG/Respiration Monitoring
※ Wash the skin thoroughly with soap and water. (Do not use ether and pure alcohol, as this will increase
the skin's impedance).
※ Dry rub the skin to increase capillary blood flow to tissues and removes skin debris and grease.
2) Prior to the placement of the electrodes, install the spring clip or snap.
3) Place the electrodes on the patient’s body; if the used electrodes are free of conductive paste, apply the
conductive paste before placing.
4) Connect the electrode leads to the patient cable.
5) Connect the power of the Monitor.
Warning
Attach the electrodes carefully and ensure good contact.
Warning ECG/Respiration Monitoring User’s Manual for Fetus/ Pregnant Woman/ Patient Multi-parameter Monitor 38
Check if the ECG electrode patches irritate the skin every day. If there are signs of allergy, replace the
electrodes or change position every 24 hours.
[Note]
To protect the environment, the used electrodes must be recycled or properly disposed of.
Warning
Before monitoring starts, check if the leads are normal.
10.3.3 Installing ECG Leads
See Fig. 10-1 for the position of ECG monitoring electrodes.
Upper Right (RA): First intercostal of the midclavicular line in the right edge of the sternum.
Lower Right (RL): At the level of the xiphoid on right midclavicular line.
Center (C): Fourth intercostal in the left edge of the sternum.
Upper Left (LA): First intercostal of the midclavicular line in the left edge of the sternum.
Lower Left (LL): At the level of the xiphoid on left midclavicular line.

Fig. 10-1 Conductive Electrodes Placement


[Note]
To ensure patient safety, all leads must be connected to the patient.
Warning
In the use of electrical surgical (ES) equipment, never place the electrodes on the grounding plate near the
electrical surgical equipment, otherwise the ECG signal will have a lot of interference.
10.4 Respiration Monitoring

10.4.1 How is respiration measured?


The Monitor measures respiration with the thoracic impedance of the two electrodes. The changes in
impedance between the two electrodes (due to activity of the thorax) produce a respiratory wave on the
screen.

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ECG/Respiration Monitoring
10.4.2 Respiration Monitoring Settings
Respiration monitoring doesn’t require additional electrode, but the electrode placement is very important.
Due to the clinical condition of some patients, the lateral expansion of the thorax results in negative
intrathoracic pressure. In this case, it is best to place the two respiration electrode in the largest region when
the right axillary line and left thoracic breathe to obtain the best respiratory wave.
[Note] ECG/Respiration Monitoring User’s Manual for Fetus/ Pregnant Woman/ Patient Multi-parameter Monitor 39
Respiration monitoring doesn’t apply to the patients with large range of activities, as this may lead to false
alarms.
Respiration monitoring examination:
1) Prepare patient skin before placing the electrodes.
2) Install spring clip or snap to the electrodes, and place the electrodes onto the patient according to the
method described in 10.3.2.
3) Connect the power of the monitoring system.
[Note]
Place the green electrode and red electrode diagonally for optimum respiratory wave. Avoid liver and
ventricle in the connection line of the electrodes, so as to avoid artifact caused by heart overwriting or
pulsating blood flow, which is particularly important for newborns.
10.4.3 Set-up
Set-up—》Parameters—》Respiration
Waveform gain: Respiration waveform gain 0.25X、0.5X、1X、2X、4X
Waveform speed: Respiration waveform shows 6.25mm/s、12.5mm/s、25mm/s
Alarm switch: Whether enable Respiration parameter out--of--limit alarm; ON ------ Enable; OFF
------Disable.
Alarm levels: Alarm priority: high, medium and low.
Upper alarm limit: High limit of parameters alarm.
Lower alarm limit: Lower limit of parameters alarm.
10.5 Maintenance and Cleaning

Warning
Turn off the Monitor and cut off the AC power before cleaning the Monitor or probe.
If the ECG cable is damaged or aging, replace a new cable.
Cleaning
The Monitor and probe surface can be cleaned with medical alcohol and dried naturally, or with a clean, dry
cloth.
Sterilization
In order to avoid long-term damage to the product, we recommend sterilizing the product only when it is
deemed necessary according to hospital procedure. We also recommend cleaning the product before
sterilizing.
Bactericidal materials recommended for the Monitor:
Ethanol based: 70% alcohol
Disinfection
In order to avoid long-term damage to the product, we recommend disinfecting the product only when it is
deemed necessary according to hospital procedure. We also recommend cleaning the product before
disinfecting. Body Temperature Monitoring User’s Manual for Fetus/ Pregnant Woman/ Patient Multi-parameter Monitor 40

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Body Temperature Monitoring

Charpter11. Body Temperature Monitoring


 Temperature Monitoring
 Maintenance and Cleaning
11.1 Temperature Monitoring

This Monitor only has one body temperature measurement channel, which allows measuring the body
temperature with the body temperature probe.
11.1.1 Body temperature measurement settings
If you are using disposable body temperature probe, insert the body temperature cable into the interface,
and then connect the probe and the cable. For reusable body temperature probes, you can insert it directly
into the interface.
Attach the body temperature probe to the patient firmly.
The temperature units include Celsius and Fahrenheit; to switch the temperature unit, adjust in ECG & Body
Temperature Settings menu.
11.1.2 Set-up
Set-up—》Parameters—》TEMPERATURE

Temperature unit: ℃ (Celsius) and ℉(Fahrenheit) available

Alarm switch: Whether enable Respiration parameter out--of--limit alarm; ON ------ Enable; OFF
------Disable.
Alarm levels: Alarm priority: high, medium and low.
Upper alarm limit: High limit of parameters alarm.
Lower alarm limit: Lower limit of parameters alarm
Warning
Check if the probe cable is normal before monitoring.
Warning
Hold the temperature probe and cable carefully, and roll into a loose ring when the probe and cable are not
used. If the cable is pulled too tight, it will lead to mechanical damage.
Warning
Calibrate the body temperature measuring instrument every two year (or according to hospital procedures).
When calibration is required, please contact the manufacturer.
11.2 Maintenance and Cleaning

Warning
Before cleaning the Monitor or connected probe, turn off the unit and disconnect the AC power.
Reusable body temperature probe
1) The heating of body temperature probe must not exceed 100°C. It is tolerant to 80°C ~ 100°C
temperatures for short time only.
2) Do not disinfect the probe with steam.
3) Only disinfect with detergent containing alcohol.
4) When use rectal probe, cover with protective colloid.
5) When cleaning the probe, hold the head end with one hand, and scrub the probe with moistened lint-free
cloth downwards toward the connector with the other hand.

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Records review and Score

Chapter12. Records review and Score


 Records list
 Data review
 Score
 Alarm
12.1 Records list

Press ‘More’->‘Search’ to Record Interface. See Fig. 12-1.

Press go to Query interface,user can input Mother ID/name/age/date to search.

【Cancel】Can not check record


【Delete】 Empty check request
【OK】 Confirm checkup and close dia-box.

12.2 Data review

Check the data of a record. See Fig. 12-2.

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Records review and Score

Fig 12-2 Data review


①Monitoring information

ID/name/age/gestational weeks and days/monitoring start time and finish time/the printer state.
② Waveform area: From top to Bottom, FHR wave, FM wave, TOCO wave. User can rotate the knob to
left/right to check the waveform.
③ Button

NIBP list: the corresponding NIBP record


Alarm list: the corresponding alarm information of the record
Score: enter the scoring interface. If monitoring duration is less than 10min, no scoring.
Print: start/stop printing
Return: return to the records list interface
12.3 Score

12.3.1 Score Interface

At the Data review interface, click to enter the Score interface. ( see Fig 12-3)

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Records review and Score

Fig 12-3 Score Interface


The duration between two vertical lines is 1minute.
Scoring: Minimal time duration is 10-minute and the maximal time duration is 120-minute.
Each time, user can only choose one FHR for scoring. If change mother ID, FHR channel will go to default
FHR1 for further scoring. The principle is : Available FHR source as default; if FHR1/FHR2 both available or
not available, choose FHR1.
12.3.2 Operation

(1) : Click it, cursor turns to red; click waveform area, move the cursor to a starting point for score. Click

again to exit.

(2) : Clict it, cursor stops to a stop point for score.


Start point and Stop point: minimum gap is 10min; if less than 10min, alarm prompt: Data length is less
than 10min. Please re-select.

(3) : Choose FHR1 score or FHR2 score.

(4) : Analyze the selected data, and display results near to the selected waveform.
Click the icon, and the analysis result will be displayed. Click again, and the analysis result will be cleared.

(5) : display score result.


Click the icon, and the score result table will be displayed. Click again, table will be cleared. Click 【Print】
to print out waveform , analysis and score result.

(6) : When the printer is connected, click the icon to print; when the printer is disconnected, ‘No Printer’
will show up when you click the icon.
Click “Analysis” √ √ × ×

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Records review and Score
Click “Result” × √ √ ×
Printing content FHR graph, Analysis , Score result FHR graph, Blank Score
Note: √ means proceed this operating; × do not proceed this operating.

(7) : Click the icon to return to the records list interface.


[Note]
Before entering the scoring mode, select score criteria.
Score Criteria ACOG Fischer
Data Duration 9-20min 18-30min
12.4 Alarm

If the monitoring data is lessen than 10 minutes, following dialogue prompt:

Normal score data should be 10-120min. If the time length between two scales is less than 10 minutes or
longer than 120 minutes. The display shows prompt box:

Click ‘OK’ to shutdown the dialogue box. Go on monitoring.

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Printing

Chapter 13. Printing


 Installing Printing Paper
 Print Settings
 Print
 Cleaning the Printing Head
13.1 Installing Printing Paper

The printer is retractable one as below pictures. It is 152mm size thermal printer paper,
installation steps as below

Picture 13-1 Slot of Printer

(a) (b) (c)


Picture 13-2 Install the printer paper
Steps to install printer paper:
1. Open the printer slot, spread the uppermost page of printer paper from outside (close to the machine)
to inside (close to the user) as picture 13-2(a), then you will see the thermosensitive grid on it, grid of FHR is
on the left, grid of TOCO is on the right, (if opposite order, spread from inside to outside, the place of FHR and
TOCO will be opposite, and it is wrong operation), and then put the pack of paper inside as picture 13-2(b).
2. Pull out a small length of printer paper, make sure both sides of it are kept in line with the printer two
slots as picture 13-2(c).
3. Close the printer door lightly.
[Note]
If the printer compartment door is open or if the printer has no paper, the instrument will sound an alarm
and prompt in the message area.

13.2 Print Settings

Print Alarm: On: running out of paper or printer door is not closed, trigger alarming;
Off: no alarming for above-mentioned situation:
Print Speed: 1cm/min, 2cm/min, or 3cm/min selectable
Print Density: Thicknesss of waveform curve is adjustable.
Printing period: 0-60 min selectable; after reach preset printing duration, auto stop printing; if choose 0, no
printing time limit.
Auto scoring print: On: Score result will show on the paper;
Off: Score result will not show on the paper. See 13.3

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Printing
Printing baseline:
On: Activate and print out baseline;
Off: Not printout baseline or stop printing baseline.
Please follow below instruction to fit different scale of 152mm thermal paper,
Adjust the printing position of TOCO 0/Adjust the printing position of TOCO 100
Adjust the printing position of FHR 90/Adjust the printing position of FHR 210
Printing baseline, “On”, 4 straight lines will show on the paper, they falls on FHR 210/ FHR90/TOCO100/TOCO
0. If some lines have position deviation, click this item for adjustment; or press , move cursor to right side
rotate knob to the deviated items, make minor adjustment. After finish baseline adjustment, choose “Off” to
stop baseline printing.
13.3 Print

To print, press the Print button once. Press again, stop printing; During “Freeze” status, printing function does
not work.
13.3.1 Printing and monitoring
Conditions Action Phenomenon
Monitoring goes on, printing
Stop printing
Start monitoring, then stopped
trigger printing Monitoring stopped, printing
Stop monitoring
stopped
Before monitoring, start printing Stop printing Monitoring stopped, printing
start monitoring Stop monitoring stopped
13.3.2 Clearing Paper Jam
If the sound of recorder and output of the thermal paper are abnormal, open the printer door to check paper
jams. To clear the jam:
1. Open the printer compartment door;
2. Take out the jammed paper in the printer;
3. Pull out the printing paper for a small fraction, and ensure that both sides of the paper and both sides of
the compartment door are substantially parallel;
4. Gently close the printer compartment door.
13.4 Cleaning the Printing Head

Non-failure working time of the thermal printer head can reach over 20 years. This is only the electrical
guarantee. The printing paper and operating environment cleanliness have great influence on the printing. If
the print is not clear or some areas can’t be printed, clean the printer head as below:
1. Turn off the Monitor
2. Open the printer panel
3. Insert a cotton swab dipped in anhydrous ethanol onto the thermosensitive element of the print head
(visible thin black thermal tape on the print head), move around and wipe gently, especially in the area of
unclear printing, and turn on the instrument after a few minutes.
4. If the problem is not completely eliminated, repeat step 3.

Fetal/Maternal Monitor User Manual Page 45 of 61


Alarm

Chapter 14. Alarm


 Alarm Category
 Alarm Level
 Alarm Indication

Alarm is a means of prompt when the patient monitoring data and the state of the Monitor have
abnormalities. The alarm category includes physiological and technical. Alarm indication means include
audible alarm, warning LED indicator flashing and text prompt.
14.1 Alarm Category

Monitor alarms mainly refers to the physiological alarms and technical alarms. Physiological alarms are
generated when the physiology of the patient is abnormal. Technical alarms are generated when the Monitor
or the application part can’t monitor the patient properly.
14.1.1 Physiological Alarms
Physiological parameter alarm requires the following three conditions:
1) Alarm switch is ON;
2) The parameter value is out--of--limit and the duration exceeds the set alarm delay;
3) Alarm occurs in the non--suspension period of alarm.
The physiological alarms of this Monitor include:
FHR1 high / low SPO2 value high / low
FHR2 high / low Pulse rate value high / low
Systolic pressure high / low Respiration value high / low
Diastolic pressure high / low Body temperature value high / low
Mean pressure high / low HR value high/low
Cardiac arrest Asphyxiation alarm
14.1.2 Technical Alarms
The technical alarms of this Monitor include:
Cuff leaks air, pressure measurement timeout, “FHR Overlap”, “Low battery”, “Probe off”, short of printing
paper, printer door is not closed, network disconnected;
[Note]
FHR overlap :If FHR 1 and FHR2 numerics gap <= 5bpm, duration is >= 10seconds, device will indicate FHR
overlap alarm.
Alarm level: low level;
Text prompt: FHR overlap, black words with yellow background;
Alarm sound: beep, beep

14.2 Alarm Level

Both technical alarm and physiological alarm have corresponding alarm levels, and need different medical
treatment.
The physiological alarm levels of the Monitor are set to high, medium, and low, and the technical alarm
level is always low.

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Alarm
14.3 Alarm Indication

When the Monitor alarms, there are three ways of alarm indication, audible alarm, warning LED indicator
flashing alarm, and text alarm.
14.3.1Audible Alarm
Audible alarm is that the Monitor automatically sends alarm sound when the alarm occurs. According to
the alarm levels, audible alarms are divided into three types.
High level audible alarm is ‘beep, beep, beep -- beep, beep’ Time interval is 10sec.
Intermediate level audible alarm is ‘beep, beep, beep’ Time interval is 20sec.
Low level audible alarm is ‘beep, beep’ Time interval is 30sec.
Note
When different levels of alarms occur simultaneously, the alarm sound is the highest level audible alarm.
14.3.2 Warning LED indicators Flashing Alarm
Warning LED indicator flashing alarm is that the alarm indicator of the Monitor changes automatically
when alarm occurs.
Alarm indicator: Flashing red ---High level alarm Flash frequency 2Hz
Flashing yellow --- Intermediate level alarm Flash frequency 0.5Hz
Constant yellow --- Low level alarm Keep on flashing
[Note]
When different levels of alarms occur simultaneously, the alarm indicator is the highest level alarm
indication.
14.3.3 Text Alarm
When the Monitor has abnormal condition alarm, the bottom of the screen displays the text prompt.
Text alarms include:
FHR1 high / low, FHR2 high / low, systolic pressure high / low, diastolic pressure high / low, mean pressure
high / low, SPO2 value high / low, and pulse rate value high / low.
FHR coincided, and low battery/Sensor off.
Alarm text: Red background, black text flash- High level alarm, flash frequency 0.8Hz
Yellow background, black text flash- Middle level alarm, flash frequency 0.8Hz
Yellow background, black text no flash- Low level alarm, flash frequency 0.8Hz
[Note]
Text alarm messages will be prefixed with star symbols:
High level alarm------*** Intermediate level alarm------** Low level alarm------*

14.4 Alarm pause and alarm Scilent(mute)/reset

Press the button to pause alarm.

Press the button to enable alarm mute / reset function.


Alarm mute / reset function is achieved by controlling the alarm sound; while the LED flashing alarm and text
alarm are not affected.

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Alarm

Default Alarm pause Alarm mute


alarm level alarm During the Alarm During the
(high/ pause alarm pause, mute alarm mute,
middle/ new alarms new alarms
low) occur occur,
Physiological Audible Alarm Yes No No No Yes
alarms Visual Alarm Yes No No Yes Yes
Text Alarm Yes No No Yes Yes

Technical Audible Alarm Yes No Yes No Yes


alarms Visual Alarm Yes Yes Yes Yes Yes
Text Alarm Yes Yes Yes Yes Yes
[Note]
1. During the alarm pause, if new technical alarms occur, the alarm will turn to normal state.
2. Normal state: no alarm pause or alarm mute/reset.
3. During the alarm mute, if new alarms occur, the mute will stop and the alarm will turn to normal state.
4. If power failure last less than 30seconds, alarm setup keep unchanged; if over 30 seconds, alarm setup will
go back to default.
14.5 Alarm Verification

Power on the device, connect with 3-to-1 probe.


Go to Setup-Parameter-FHR-Alarm on/off, choose On Alarm level, choose High
Alarm high limit: 160bpm Alarm delay-15
Gently pat the FHR probe to generate FHR beat, pat quickly to generate FHR reading over 160bpm and last
over 15sec. If alarm indicator turn to red and “FHR 1 High” prompt and “‘beep, beep, beep -- beep, beep”
sound output, it indicate alarm function works; if not, alarm does not work.
Table 14-1 Default Alarm Limits of Parameters
Type Default Alarm Lower Range High Range Default Alarm Step
Levels Limit Range
FHR High 90-120 160-190 120-160 10
SPO2 Med 85-(upper limit -1) (lower limit+1)-100 90-100 1
Pulse Rate Med 30-( upper limit-1) (lower limit +1)-240 50-120 5
Noninvasive Blood Pressure (mmHg)
Systolic Pressure Med 30-(upper limit-1) (lower limit +1) -250 90~160 5
Diastolic Med 30-(upper limit-1) (lower limit +1) -250 50-90 5
Pressure
Mean Pressure Med 30-(upper limit-1) (lower limit +1) -250 60-110 5
HR MED 30-(upper limit-1) (lower limit +1) -240 50-120 1
RESP MED 6-(upper limit-1) (lower limit +1) -60 8-30 1
TEMP MED 30-(upper limit-0.1) (lower limit +0.5) -50 36.0-39.0 0.1

Fetal/Maternal Monitor User Manual Page 48 of 61


Networking

Chapter 15. Networking


 wifi setup
 Networking setup
 System setup
Fetal monitor can communicate with central station by WIFI or Ethernet.
Networking icon:

wifi connection; network disconnected ; Ethernet connected, CMS disconnected;

CMS connected.

15.1 wifi Setup

Setup--》wifi--》On
Wifi name listed on right side, choose WIFI needed, click it for connection; after connected, WIFI icon

shows on monitoring interface.

15.2 Ethernet setup

Setup—》Ethernet—》On
Ethernet card shows on right side, click it and set as per real situation.
15.3 System Setup

Setup—》System—》Central station IP
Input Central station IP address manually.

Fetal/Maternal Monitor User Manual Page 49 of 61


Appendix 1: Troubleshooting

Appendix 1: Troubleshooting
Failure Possible Reason Solution
Power cable poorly connected.
No display when unit switched
Power failure, power plug or socket Check adapter and power cable.
on.
badly connected.
FHR module is not well connected Re-connect FHR module or replace it.
Interface is normal, but cursor
with main board, or FHR board
does not move
module is damaged.
Transducer poorly connected with Re-connect.
instrument. Re-adjust the ultrasound transducer.
Fetal heart not found, the place of Add gel.
Abnormal FHR value transducer is incorrect. Re-adjust the ultrasound transducer when
No gel or little gel. signal recovered.
Fetal/maternal activity. Replace the ultrasound transducer.
The transducer is broken.
Transducer poorly connected with
instrument. Re-connect the ultrasound transducer.
The place of transducer place is Re-adjust the ultrasound transducer.
Abnormal TOCO value
incorrect. Reset the TOCO value.
No pressure reset Waiting the contractions appears.
No contraction
Press the TOCO transducer, The initial output value should be Re-adjust the inner potentiometer inside
the TOCO value does not re-adjusted. the transducer.
change or changes a little only. TOCO transducer broken Replace the TOCO transducer.
Press the marker, no icon is
Bad marker. Check with a multimeter and confirm.
displayed and printed
Increase the volume
No sound from speaker Volume is too low
Speaker is failed
Printer is working, but no FHR
curve, TOCO curve on paper, The paper is inversely installed. Re-load the paper with the thermal side
or the FHR curve and TOCO Or right side and left side is inversed. facing the printer head.
curve is not in right area.
Light printing deepness Adjust the printer deepness.
Print unclearly or some parts
Unqualified paper Replace the paper.
can’t be printed out
Dirty printer head. Clean the printer head.
Reload the paper.
Paper is not loaded at its place.
Paper goes with alias Replace with qualified paper.
Using other brand printer paper
Printing data position error Re-adjust the printing data position
Printing position is not calibrated.
according to this manual.
Enter Maintenance setting, and turn the
Rating table isn’t printed Rating switch is off
rating switch to ON

Fetal/Maternal Monitor User Manual Page 50 of 61


Appendix 2: Specifications

Appendix 2: Specifications
Product name: Fetal/Maternal Monitor
Model: MF-9200
Power supply: AC 100-240V, 50/60Hz
Power consumption: < 80VA
Battery: 14.8V lithium battery, 2200mAh
Charging mode: Connect the Monitor to AC power and battery charging is started automatically
Discharge protection: In battery-powered mode, the Monitor will automatically turn off when the battery
nearly runs out.
Device Storage: 3000 hours
Charging time: 3 hours
Battery working time: 5 hours
Fetal Heart Rate:
Transducer: Multi-crystals, Wide beam, pulsed doppler, high sensitivity.
Strength: <5mW/cm2
Working frequency: 1.0MHz
Signal processing: special digital signal.
Measurement range: 50~210 bpm / 30-240bpm
Alarm Range:
High limit: 160,170,180,190 bpm
Lower limit: 90,100,110,120 bpm
Maximum audio output: 2 W
TOCO:
Measurement range: 0~100 units
Maternal SpO2 measurement:
Measurement scope : 70%~99%。
Measurement accuracy: ±3%
Pregnant HR Measurement:
Measurement scope: 30bpm~240bpm
Measurement accuracy: ±2 bpm
Non-invasive blood pressure measurement
Measuring Range
a) Systolic pressure: 6.7~32.0kPa (50~240mmHg)
b) Mean pressure: 3.4~26.6kPa (25~200mmHg)
c) Diastolic pressure: 2.0~24.0ka (15~180mmHg)
Accuracy: ±1.1kPa (±8mmHg) or reading ± 5%, whichever has the greater absolute value;
Measurement mode: manual / automatic NIBP measurement;

Display:
The TFT displays FHR, TOCO, FM, maternal parameters, time, date, volume and so on, it support freeze
and review monitor data.
Resolution: 800x600
Dimension: 350x320x85 (mm) (L X W X H)
Net weight:1.75kg

Fetal/Maternal Monitor User Manual Page 51 of 61


Appendix 2: Specifications

Environment
Working environment: Temperature: +5℃ ~ +40℃; Humidity: 30%~75%
Atmospheric pressure: 86kPa ~ 106kPa
Transport and storage temperature: Temperature: -10℃ ~ +55℃; Humidity: < 95%
Atmospheric pressure: 86kPa ~ 106kPa
Probe acoustic output: In accordance with the provisions of 1992 IEC1157, negative peak sound pressure
shouldn’t exceed 1 MPa, and the beam intensity shouldn’t exceed 20mW/cm2. Spatial
peak instantaneous average intensity density shouldn’t exceed 100mW/cm2. The sound
intensity of this model does not exceed 5mW/cm2. Sound output meets the conditions
exempted from publication.

Fetal/Maternal Monitor User Manual Page 52 of 61


Appendix 3: Accessories

Appendix 3: Accessories

Three-in-one probe
FHR probe
Uterine contraction pressure probe
Fetal movement mark button

FHR secondary probe: for twins

Fetal wake-up device

SPO2 Sensor

NIBP cuff

Fetal/Maternal Monitor User Manual Page 53 of 61


Appendix 3: Accessories

ECG cable

ECG electrode

Temp Probe

Power cord

Belt

Thermal printing paper

Fetal/Maternal Monitor User Manual Page 54 of 61


Appendix 4: Symbols

Appendix 4: Symbols
Symbol Note Symbol Note

FHR1 Three-to -one socket FHR2 FHR2 socket

BF-applied part, not against


WARER Fetus waker socket
Defibrillator.

Refer to attached documents. Volume up key

It indicates that this device is BF


applied devices, is against Defibrillation Volume down key
function.

on-off key Print key

Freeze key Battery indicator

Protective grade, against


TOCO reset key
water splash.
In compliance WEEE Dispose
Power indicator
standard.

Charge indicator In reference to User Manual

CF-applied part, against


Equalqpotential
Defibrillator.

Fetal/Maternal Monitor User Manual Page 55 of 61


Appendix 5: Guidance and Manufacturer’s EMC Declaration

Appendix 5: Guidance and Manufacturer’s EMC Declaration


Table1 Guidance and manufacture's declaration - electromagnetic emission - for all EQUIPMENT
AND SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic emission
The MF-9200 Fetal/Maternal Multi-parameter Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the MF-9200 Fetal/Maternal
Multi-parameter Monitor should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment Guidance
RF emissions Group 1 The MF-9200 Fetal/Maternal Multi-parameter Monitor uses
EN55011 RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment
RF emissions Class A The MF-9200 Fetal/Maternal Multi-parameter Monitor is
EN55011 suitable for use in all establishments other than domestic,
Harmonic emissions Class A and may be use in do mestic establishments and those
EN 61000-3-2 directly connected to the public Iow-voltage power supply
Voltage fluctuations / Complies network that supplies buildings used for domestic purposes,
flicker emissions provided the following warning is heeded.
EN 61000-3-3

Table2 Guidance and manufacture's declaration - electromagnetic immunity - for all EQUIPMENT and
SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The MF-9200 Fetal/Maternal Multi-parameter Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the MF-9200 Fetal/Maternal Multi-parameter
Monitor should assure that it is used in such an environment.
EN60601 Electromagnetic
Immunity Test Compliance Level
test level environment-Guidance
Floors should be wood, concrete or
Electrostatic
±6KV contact ±6KV contact ceramic tile. If floors are covered
discharge(ESD)
±8KV air ±8KV air with synthetic material, the relative
EN 61000-4-2
humidity should be at least 30%.
±2KV for power Mains power quality should be that
Electrostatic ±2KV for power
supply lines of a typical commercial or hospital
transient/burst supply lines
±1KV for environment.
EN 61000-4-4
input/output lines
±1KV differential ±1KV differential Mains power quality should be that
Surge
mode mode of a typical commercial or hospital
EN 61000-4-5
±2KV common mode ±2KV common mode environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that
interruptions and (>95% dip in UT) (>95% dip in UT) of a typical commercial or hospital
voltage variations for 0.5 cycle for 0.5 cycle environment. If the user of the
on power supply MF-9200 Fetal/Maternal
input lines 40% UT 40% UT Multi-parameter Monitor requires

Fetal/Maternal Monitor User Manual Page 56 of 61


Appendix 5: Guidance and Manufacturer’s EMC Declaration
EN 61000-4-11 (60% dip in UT) (60% dip in UT) continued operation during power
for 5 cycles for 5 cycles mains interruptions, it is
recommended that the MF-9200
70% UT 70% UT Fetal/Maternal Multi-parameter
(30% dip in UT) (30% dip in UT) Monitor be powered from an
for 25 cycles for 25 cycles uninterruptible power supply or a
battery.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power Power frequency magnetic fields
frequency(50/60Hz) should be at levels characteristic of
3A/m 3A/m a typical location in a typical
magnetic field commercial or hospital
EN 61000-4-8 environment.
NOTE UT is the a. c. mains voltage prior to application of the test level.

Table3 Guidance and manufacture's declaration - electromagnetic immunity - for EQUIPMENT and
SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The MF-9200 Fetal/Maternal Multi-parameter Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the MF-9200 Fetal/Maternal Multi-parameter
Monitor should assure that it is used in such an environment.
Immunity test EN 60601 Compliance Electromagnetic environment-guidance
test level level
Conducted RF 3Vrms 3V Portable and mobile RF communications equipment
EN61000-4-6 150kHz to should be used no closer to any part of the MF-9200
80MHz Fetal/Maternal Multi-parameter Monitor, including
cables, than the recommended separation distance
calculated from the equation applicable to the
Radiated RF 3V/m 3V/m
frequency of the transmitter.
EN61000-4-3 80MHz to
Recommended separation distance
2.5GHz

80MHz to 800MHz

800MHz to 2.5GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a should
be less than the compliance level in each frequency

Fetal/Maternal Monitor User Manual Page 57 of 61


Appendix 5: Guidance and Manufacturer’s EMC Declaration
range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800MHz, the higher frequency range applies.


NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the MF-9200 Fetal/Maternal Multi-parameter Monitor are used exceeds the applicable
RF compliance level above, the MF-9200 Fetal/Maternal Multi-parameter Monitor should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the MF-9200 Fetal/Maternal Multi-parameter Monitor.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table4 Recommended separation distances between portable and mobile RF communications


equipment and the EQUIPMENT or SYSTEM-for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and
the MF-9200 Fetal/Maternal Multi-parameter Monitor.
The MF-9200 Fetal/Maternal Multi-parameter Monitor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the
MF-9200 Fetal/Maternal Multi-parameter Monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the model MF-9200 as recommended below, according to the maximum output
power of the communications equipment.
Rated Maximum Separation Distance According to Frequency of Transmitter(m)
Output of Transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
(W)

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Fetal/Maternal Monitor User Manual Page 58 of 61


Appendix 6: Table 201.103 Acoustic Output Reporing Table

Appendix 6: Table 201.103 Acoustic Output Reporing Table


Transducer mode: PW Doppler
Frequency:1.0MHz
TIS TIB
Index Name MI Non-scan TIC
Scan Non-scan
Aaprt  1 cm 2
Aaprt > 1 cm 2

Max. Index 0.02 - - 0.002 0.03 (a)


pr.a 0.017
P - - 4 #
Min.Pα(zs) &
0.46
Min. Ita,α(zs)

zs 2.0
Associated zbp 1.8
acoustic zb 2.0
parameter
z ( At Max. Ipi,α ) 2.0
deq(zb) 1.2
fawf 1.0 - - 1.0 1.0 #

Aaprt X - - Φ1.2 Φ1.2 #


Diameter Y - - Φ1.2 Φ1.2 #
td 903.9
prr 1250
Other
pr (Max Ipi) 0.018
Information
deq( Max . Ipi ) 1.2
Ipa.3( Max MI) 0.00

Operating - -
Control - -
Conditions - -
Note1: Data should only be entered in one of the columns related to TIS.
Note2: Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for
transcranial or neonatal cephalic uses.
Note3: If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the columns related to
TIS, TIB or TIC.
Note4: If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the column related to
MI.
Note5: Focal Length is a NOMIMAL value
(a) Intend use does not include cephalic so TIC is not computed
# No data reported

Fetal/Maternal Monitor User Manual Page 59 of 61


To protect your rights of repair service, please take a few minutes to fill out the Warranty Card as follows:

Warranty Card
Product Name
Product Type

No.

Date of Purchase
Warranty Period
Name
Telephone
Client Information
Fax

Address

□ Internet
□ Exhibition
Sources of information □ Magazine
□ Recommended by salesman
□Other
Assessment

Fetal/Maternal Monitor User Manual Page 60 of 61

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