L8ME-User-Manual
L8ME-User-Manual
User Manual
Version: V1.1
Date: 04.2020
No.: 1.263.0250-11
About User Manual
This is only available for this fetal monitor. We will not undertake any results and blames caused by using
for other purposes
No part can be photocopied, copied, and translated it into other languages without the prior written
consent.
The data of this manual can be changed without notice.
Due to technical update or special requirements of users, without affecting the performance index of
monitor, some parts may be different with the standard configuration as this manual said, please note.
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.
Chapter 1 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
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.
Bluetooth maximum communication distance is 5meters. Distance between Bluetooth probe and main
device should be within 5 meters, otherwise there may be signal loss and unstable sound.
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.
It is intended to be used to monitor Fetus Heart Rate, Fetal Movement, mother TOCO.
Contraditions: Do not use during Defibrillation, Electrosurgery, or Magnatic Resonance Imaging(MRI).
Chapter 2 Installation
Unpacking and checking
Power supply
Starting up
Connecting the probe
Checking the Printer
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
● ultrasonic probe U/S, uterine contraction probe TOCO and an event marker
● Second ultrasonic probe (optional)
● Belt
● Printing paper
● 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
Use the power cord along with goods. Plug the power cord into the power socket and the other end into
power outlet which has grounding wire.
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 “-”.
Caution: AC power cable need regular checkup, usually every 3 months. Please replace it if there is any
problem.
Caustion: AC power need to connect with good power inlet with grounding connection. If there is grounding
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.
Check if paper runs out after pressing “Printing button.”If no paper out, please check Chapter 10.
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.
2. Blood pressure measuring button: No use
3. Freeze button: Press this button once to freeze the system, and the main interface displays “Freeze”; 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 the setup surface, switch cursor to the left.
5. VOL+ button
In monitoring state, press this button in the main interface to turn up the speaker volume.
In the setup surface, switch cursor to the right.
6. Print button
Before monitoring, press it, mother information interface prompt.
After monitoring finished, press it, activate record printout, click analysis and scoring, and realize scoring
printout.
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. Rotate knob
In monitoring state, rotate the Rotate knob, press the Rotate knob to confirm when the selected area
displays a blue frame, and then enter the appropriate settings.
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:10.2-inch TFT display shows waveforms, menus, alarms and physiological measurement
parameters.
11. Probe holder: used to hold the probe.
12. AC Indicator:
When this indicator is green, it shows that the Monitor is connected to the external AC power.
13. 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.
14. Battery status indicator: when this indicator is green, the Monitor is powered by internal batteries.
Port Introduction
FHR1: Wireless FHR1 probe
FHR2: Wireless FHR2 probe
WAKER:Fetal acoustic stimulator (FAS) port (option)
①:AC adapter input socket
②:Power switch. Turn on or off the power. ━: turn on; O: turn off.
NET: network port of central nurse station
RS232:retained
4.1 Overview
The display of the Fetal/Maternal Monitor is a 10.2-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 4-2.
Speaker volume indicator: Level 0– Level 7, sound goes up from Level 0 to Level 7.
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.
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.
【Mother Info】: 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.
【Vol -】: Click this button, the volume of the fetal heart decreases.
【Vol +】: Click this button, the volume of the fetal heart increases
【Toco】: Press this button to preset TOCO calibration value.
【 Freeze 】 : Press this button once to freeze the system, and the main interface displays “Freeze”; press it
again to real-time scanning state.
【More】:: Press this button to find hidden functions.
【Alarm pause】: Click this button, enter Alarm pause state, the duration is 2min.
【Alarm mute】: Click this button to enter the alarm mute state.
【History】: Go to Record List
【Screen】: Click to change Interface
【Setup】: Press this button to enter the Setup interface.
【Return】: Press this button to go back to the previous menu.
5.1 Appearance
Probe display
BED 3:ID No. It can be changed in setup of main device. After new setup, user needs to repairing the
probes.
US1/US2/TOCO: US1- Ultrasound Probe 1( FHR1), US2- Ultrasound Probe 2( FHR2) , TOCO- TOCO
probe
:Probe battery status. :Charging.
:Means good connection between probe and main device; if not well disconnection, shows .
Note: US,TOCO probes can not be paired if they are already connected
The probes can not be re-paired if the fetal monitor has connected with other wireless probes
Note:1)After successfully paired, probe will indicate type of probe, setup ok, bed No., and it will ‘di’ when
you press the button.
2)The wireless ID can’t be repeated in the same room to avoid wireless probes mixture
3)To avoid any influence WLAN has on the fetal monitor, 84-99 working channel is recommended;
Recommended working channel like below:
Wireless ID 5 6 7 8
Channel2 85 89 95 99
Wireless ID 9 10 11 12
Channel2 84 88 92 96
Wireless ID 13 14 15 16
Channel2 94 98 86 90
Wireless ID 17 18 19 20
Channel2 93 97 87 91
Wireless ID 21 22 23 24
Channel2 85 89 95 99
Wireless ID 25 26 27 28
Channel2 84 88 92 96
Wireless ID 29 30 31 32
Channel2 94 98 86 90
Charging
Return the probes to socket for charging.
Power indication
An icon of battery power will display on the screen after powering on, different icons indicate the various
conditions of battery capacity, see the meaning below:
: The battery level is full;
: The battery level is low and requires charging;
: The battery is run out and requires charging immediately.
【Note】: In battery mode, the device will shut down automatically when the battery power is closed
to exhaust.
【 Note 】 Battery can be only replaced by the professional maintenance staff, please do not
disassembly by users to prevent any negative effects on probes.
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.
6.2 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.
6.3.1Setup-Paramter-FHR
Waveform Offset (for twins): If monitoring twins, to avoid FHR2 wave form overlap 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.
Waveform speed: Adjust wave form sweeping speed; available options are 1cm/min,2cm/min,3cm/min.
Alarm ON/OFF: On- FHR out of range alarms; Off- FHR out of range, no alarm.
Alarm Level: high, medium and low.
Alarm high limit: High limit of FHR alarm; options are 160, 170, 180, and 190 bpm.
Alarm low 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.
FHR2 sensor alarm ON/OFF: On- Generate alarm if FHR2 probe disconnected; Off- Do not generate alarm if
FHR2 probe disconnected. ( It is only effective when the probe type is wired. )
6.3.2 Setup-Sound
FHR sound channel: FHR galloping sound channel, FHR 1/FHR2 alternative
FHR1 sound level: The volume outputted is from FHR1, 0-7 available
FHR2 sound level: The volume outputted is from FHR2, 0-7 available
Alarm sound level: The volume outputted is from alarm voice, 1-3 available
[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.
6.4 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.
6.4.1 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;
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.
6.4.2 Single Fetus Monitoring
Monitor one fetus. Identify the fetal heart position and tie the ultrasonic probe according to 6.4.1 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.
6.4.3 Twins Monitoring
Monitor twins. Identify the fetal heart position and tie the master and secondary ultrasonic probes according
to 6.4.1 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.
6.5 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
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.
6.6 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.
6.6.1 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%
6.6.2 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:
7.1 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.
7.2 TOCO Settings
Automatic fetal movement mark: ; manual fetal movement mark: ; wake--up device mark:
8.1 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.
woman should keep quiet, so that accurate results of automatic fetal movement monitoring can be obtained.
8.3 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.
8.3.1 Fetal Wake-up Device
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.
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.
8.3.3 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.
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 9-3)
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:
If not detecting of USB disk, “Failed to detect any external storage card” will prompt.
[Warn] Records cannot be recovered after deletion, please use this operation with caution.
1) Setup->System->Delete record-> input password “62596535”
2) Record delete-> Choose record Unchosen ; Chose
3) Click “Delete”, Click “Confirm”, start delete record.
Chapter 10 Printing
Installing Printing Paper
Print Settings
Print
Cleaning the Printing Head
10.1 Installing Printing Paper
The printer is retractable one as below pictures. It is 152mm size thermal printer paper,
installation steps as below
SetupPrint
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 ( 1,2,3,4,5,6,7,8)is adjustable.
Real-time printing: Turn on--it supports real-time printing during monitoring process;Turn off--it doesn’t
support real-time printing during monitoring process. For details, please refer to 10.3.
Printing baseline:
On: Activate and print out baseline;
Fetal/Maternal Monitor User Manual Page 33 of 49
Printing
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.
SetupScore:
Automatic printing score:Turn on--When the effective data is over 10 min, it will print scores and results
sheet; if less then 10 min, it won’t print; Turn off--it won’t print results.
10.3 Print
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.
Chapter 11 Alarm
Alarm Category
Alarm Level
Alarm Indication
Alarm pause and alarm Scilent(mute)/reset
Alarm Verification
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.
11.1 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.
11.1.1 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 FHR2 high / low
11.1.2 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 numeric 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.
Fetal/Maternal Monitor User Manual Page 36 of 49
Alarm
11.3.1Audible 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.
11.3.2 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.
11.3.3 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, 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.
SetupwifiOn
Wifi name listed on right side, choose WIFI needed, click it for connection; after connected, WIFI icon
SetupEthernetOn
Ethernet card shows on right side, click it and set as per real situation.
12.3 System Setup
SetupSystemCentral station IP
Input Central station IP address manually.
Appendix 1: Troubleshooting
Failure Possible Reason Solution
Power cable poorly connected.
No display when unit
Power failure, power plug or socket Check adapter and power cable.
switched on.
badly connected.
During power on, LCD Connection between FHR module Reconnect the cable or replace FHR
display normal, but no and mainboard is not good or module.
cursor moving 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
No gel or little gel. when 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
The initial output value should be Re-adjust the inner potentiometer
transducer, the TOCO
re-adjusted. inside the transducer.
value does not change or
TOCO transducer broken Replace the TOCO transducer.
changes a little only.
Press the marker, no icon
is displayed and Bad marker. Check with a multimeter and confirm.
printed
No sound from speaker Volume is too low Increase the volume
Printer is working, but no
FHR curve, TOCO curve
The paper is inversely installed. Re-load the paper with the thermal
on paper, or the FHR
Or right side and left side is inversed. side facing the printer head.
curve and TOCO curve is
not in right area.
Light printing deepness Adjust the printer deepness.
Print unclearly or some
Unqualified paper Replace the paper.
parts can’t be printed out
Dirty printer head. Clean the printer head.
Reload the paper.
Paper goes with alias Paper is not loaded at its place.
Replace with qualified paper.
Printing data position Using other brand printer paper
Re-adjust the printing data position
error Printing position is not calibrated.
according to this manual.
Fuse 120-000003-000
Belt 1.371.0007-10
Table2 Guidance and manufacture's declaration - electromagnetic immunity - for all EQUIPMENT and
SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The Fetal/Maternal Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Fetal/Maternal Monitor should assure that it is used in such an environment.
IEC60601 Compliance Electromagnetic
Immunity Test
test level Level environment-Guidance
Floors should be wood, concrete or
Electrostatic
±6KV contact ±6KV contact ceramic tile. If floors are covered with
discharge(ESD)
±8KV air ±8KV air synthetic material, the relative
IEC 61000-4-2
humidity should be at least 30%.
Electrostatic
±2KV for power supply lines
transient/burst N/A
±1KV for input/output lines
IEC 61000-4-4
±1KV differential
Surge
mode N/A
IEC 61000-4-5
±2KV common mode
<5% UT 1
Voltage dips, short (>95% dip in UT)
interruptions and for 0.5 cycle
voltage variations on
N/A
power supply input 40% UT
lines (60% dip in UT)
IEC 61000-4-11 for 5 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Power Power frequency magnetic fields
frequency(50/60Hz) should be at levels characteristic of a
3A/m 3A/m
magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
Table3 Guidance and manufacture's declaration - electromagnetic immunity - for ME EQUIPMENT AND
SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The Fetal/Maternal Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Fetal/Maternal Monitor should assure that it is used in such an environment.
Immunity Test IEC 60601 Compliance Electromagnetic Environment-Guidance
Test Level Level
Conducted RF 3Vrms N/A Portable and mobile RF communications equipment should be used
IEC61000-4-6 150k to no closer to any part of the models MT1PC1, including cables, than
80MHz the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Radiated RF 3V/m 3V/m
IEC61000-4-3 80M~2.5G
Hz 80MHz to 800MHz
800MHz to 2.5GHz
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
Fetal/Maternal Monitor
The Fetal/Maternal Monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Fetal/Maternal Monitor can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Fetal/Maternal Monitor 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 80MHz to 800MHz 800MHz to 2.5GHz
(W)
prr 2632
Other
pr (Max Ipi) 0.035
Information
deq( Max . Ipi ) 1.2
Ipa.3( Max MI) 0.01
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 51.2aa) and 51.2dd) are met, it is not required to enter any data in the column
related to MI and TI.
prr 4000
Other
pr (Max Ipi) 0.037
Information
deq( Max . Ipi ) 1.1
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.
Note4: If the requirements of 51.2aa) and 51.2dd) are met, it is not required to enter any data in the column
related to MI and TI.
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