Manual Inglês Mf9200
Manual Inglês Mf9200
Manual Inglês Mf9200
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.
class II equipment .
0482 Declaration of Conformity “The product complies with the requirements of the MDD
93/42/EEC”.
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
Fetal/Maternal Monitor User Manual Page 2 of 61
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
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
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.
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).
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.
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.
Check if paper runs out after pressing “Printing button.”If no paper out, please check Chapter 13.
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
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.
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
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
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.
Speaker volume indicator: Level 0– Level 7, sound goes up from Level 0 to Level 7.
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 ℉)
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.
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.
: 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.
: Press this button once to freeze the system, and the main interface displays “Frozen”; press it again to
: 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.
Go to Record List
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
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.
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
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.
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.
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
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.
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
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.
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
[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.
[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,
Fig. 8-2 Replacing Rubber Bags in the Cuff Fig. 8-3 Replacing Rubber Bags in the Cuff
8.4 Faults and Solutions
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
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
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
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
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.
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
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
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.
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
At the Data review interface, click to enter the Score interface. ( see Fig 12-3)
(1) : Click it, cursor turns to red; click waveform area, move the cursor to a starting point for score. Click
again to exit.
(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.
(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” √ √ × ×
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:
The printer is retractable one as below pictures. It is 152mm size thermal printer paper,
installation steps as below
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
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.
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
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.
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------*
CMS connected.
Setup--》wifi--》On
Wifi name listed on right side, choose WIFI needed, click it for connection; after connected, WIFI icon
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.
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
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
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.
Appendix 3: Accessories
Three-in-one probe
FHR probe
Uterine contraction pressure probe
Fetal movement mark button
SPO2 Sensor
NIBP cuff
ECG cable
ECG electrode
Temp Probe
Power cord
Belt
Appendix 4: Symbols
Symbol Note Symbol Note
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
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
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 #
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
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