BFM-900L: Fetal Monitor (Ver 1.1)
BFM-900L: Fetal Monitor (Ver 1.1)
BFM-900L: Fetal Monitor (Ver 1.1)
BFM-900L
FETAL MONITOR (Ver 1.1)
Head Office/Factory
687-5, Sangoan-ri, Hongcheon-eup, Hongcheon-gun,
Gangwon-do, Korea (zip.250-804)
Tel : +82-33-434-9041 Fax : +82-33-434-9043
Seoul Office/R&D
1406, Masters Tower, 553, Dohwa-dong, Mapo-gu,
Seoul, Korea (zip.121-748)
Tel : +82-2-714-2960∼2 Fax : +82-2-714-2963
Customer Service Dept.
Tel : +82-2-714-2962 Fax : +82-2-714-2963
Address of Region Representative
ET MEDICAL DEVICES SPA
VIA DE ZINIS 6, 38011 CAVARENO (TN) ITALY
Tel : +39 0463 85 01 25 Fax : +39 0463 85 00 88
OPERATION MANUAL
BFM-900L
FETAL MONITOR (Ver 1.1)
(MAR. 27. 2009)
Table of Contents
Introduction 3
General 3
Warranty Period 4
Service Request 5
How to contact us 6
INTRODUCTION GENERAL
Thank you for buying BFM-900L (Fetal Monitor). For safe use, stable performance and follow-up
management, please read this manual before using the device.
Before using the device, please read this manual to perfectly understand the basic function, using
method and maintenance method of the device, so that you can assure the safe use and long-term
stable performance of the device.
The device shall be used under the direction of the person who is medically certified.
For the patient’s safety, use only the parts and accessories recommended by us.
If you connect the device with any part or accessory not specified in the User’s Manual, you shall
notify it to us or any distributor who has the right to sell this product.
General 3
FETAL MONITOR (Ver 1.1) BFM-900L
This product is made through strict quality management and test process. This product can be The service for Bionics products can be carried out by only Bionics Customer Service Dept or the
repaired, replaced or refunded in accordance with “Consumer’s Damage Compensation person certified of such service by Bionics. If the device is repaired or tried to be repaired by any
Regulation” noticed by Economic Planning Board. person other than such certified person for the warranty period, the warranty period shall be void.
This product is warranted for 1 year. Bionics Customer Service Dept or any distributor certified of Bionics Product Service is obligated
to carry out any service requested by the user.
If broken while being used normally, this product will be freely repaired by our service center
for such warranty period. If you find any problem on the device or any risk on the human body in any hospital and place
where the device is used, the maintenance/repair work shall be promptly and fully taken.
If you find any problem on the device, please let us know the model name, device number,
purchasing date and breakage content. If you find any problem on the device, take the actions as follow:
Please immediately contact our Customer Service Dept or any distributor representing us for
our service. Check the model name, product number, purchasing date, problem or question to
ask before contacting us.
Our Customer Service Dept will check and solve the problem online first. If difficult to solve
the problem online, it will visit you to solve the problem immediately.
Please contact us at the following number to get various kinds of service, product information and
etc and to talk to the person in charge of sales. 1.1 General
Bionics service is always open to you. Please contact us at the number as follows:
This device provides you with the exact and stable values (fetus’s heart rate, patient’s uterus
shrinking level and etc) measured on the patient and fetus and correct information of the
BIONICS Co., Ltd. fetus’s status.
Customer
Tel : 82-2-714-2962 This manual covers BFM-900L, a Fetal Monitor manufactured by Bionics, which is
Center designed for maximal user’s convenience. This manual consists of independent chapters.
Some information is specified several times here in this manual.
* Before making reservation on troubleshooting, please check the
This manual is a guidebook for efficient use of BFM-900L. For clinical and pathological
model name, serial number, purchasing date and abnormality of the
information about the device, please refer to basic relevant medical books. Then, you will use
damaged product.
the function of the device better. If you refer to clinical books together with this manual, you
will expect more effects from using the device.
If you find any Problem while using, please contact us or our A/S Reservation Office.
1.2 Contents
The user must read the User’s Manual before using the device.
This manual consists of the chapters as follow:
1.3 Meaning of Symbols in the User’ s Manual CHAPTER 2 Precautions for Use
We have marked on the user manual to emphasize the following agreements. The user must
follow all warnings and remarks.
In case of improper use or poor maintenance on the equipment resulting in product defect, 2.1 Precautions of Using-Environment
neither the manufacturer nor the distributor will be responsible for any damages. Avoid using or storing the device under the environments as follow:
“WARNING” is used to notify the possibility of critical injury, death, and physical and Keep it away from wet place or Keep it away from direct
financial damage in case the warning is ignored do not use it by wet hands. sunlight.
“PRECAUTION” is used to notify the possibility of non-critical injury in case the notice is
ignored
To avoid electrical noise or disturbance, install the device away from generators, X-ray devices,
Do not disassemble it. Do not power it on before broadcasting devices, and idle wires. Inaccurate reading may show in case above mentioned
We WILL NOT be responsible under completely installed. devices are nearby. The BFM-900L requires a separate power source and stable connection.
any circumstances in this case. Otherwise, it may be damaged.
Inaccurate reading may show in case these devices are sharing the same power line.
IPX7
(DOP, UC Probes)
Basic environments for storage are as follow: If you connect other devices to use RS-232C port, you should use the devices which are satisfied
Temp : -10℃ ~ 50℃ with standard EN60601-1.
Pressure : 70 ~ 106KPa
Humidity : 20% ~ 95%
Options
- Central Monitoring Device Cable/Communication Program
- Cart
- AST Probe
- Internal Battery
Type BF Device,
UC Reference Setting
Electric Shock Device
Display
Protection
Warning or Precaution
Volume Control
(See the User s Manual.)
1) Power Connection
BFM-900L is designed to be easily used on a normal table, cart, or any other appliances
commonly found in a hospital environment. Normally, you can use the handle in the back of the
device and place it on a flat surface. Since the center of gravity of the device is low, key
manipulation on the device will not topple it over. It also does not slip.
- When you pull the door forward the door will open and you will see the area where you can place
the roll of printing paper, as well as the printer machine, and black roller on the inside of the door.
- Make sure the paper’s printing side is facing up and then close the printer door.
Printer paper should be printed side upward. If not, it will not be printed on the paper.
Check for following items before measuring the condition of the fetus.
Possibilities of any mechanical danger
Power plug and cable, and accessories
All items and equipment necessary to measure and inspect the condition of the fetus
Connect the probe you want to use on the main body. Normal procedure is as follows.
- Pre-labor diagnosis for non-twin fetus : DOP I Probe, UC Probe, Mark Jack
- Pre-labor diagnosis for twin fetus : DOP I Probe, DOP II Probe, UC Probe, Mark Jack
(1) Displays Value of FHR 1
- Wake up the baby : AST probe(optional)
(2) Displays Heart Rate Rhythm of FHR 1
Step 1) Turn on the Power Switch.
(3) Displays Heart Rate Rhythm of FHR 2
Step 2) Attach the probe to the patient. (Refer to 5.5, 5.6, and 5.7)
Step 3) Sound signal is heard. (4) Displays maximum limit of Alarm Level
Step 4) Measured signal is displayed on the FND as numbers.
(5) Displays Value of FHR 2 or Connecting Status of AST probe
Step 5) Record the measured readings with the print function.
Step 6) SETUP Key is used to modify the configuration. (Refer to 6) (6) Displays minimum limit of Alarm Level
Step 7) If you want to wake up the baby during measuring, please remove the Doppler from
(7) Indicates bar graph of measured UC value
DOP2 and connect AST probe(optional). Then press the button on the AST probe on the
patient’s abdomen. It makes sound for waking up the baby. Please do not close this device (8) Displays measured UC value
to the ear. It makes you harmful. (9) Printer Status
(11) Printing Cycle for Printer Auto-Printing. Indicate remain print time during printing
The LED located on the key area of the front face Panel displays the status of the used Power.
(1) AC Power: LED lights up while AC Power being used
(2) Battery(Optional): LED lights up while Battery Power being used
■Keys on Front Face
■Alarm Lamp
The LED located on the top of the front face Panel displays Alarm and Heart Rate Rhythm.
The DOP and UC Probe used in BFM-900L previous models are designed to be
used under water.
Doppler and UC probes are applied by IPX7 so they can be used for the underwater delivery
in the water.
■Probe Connection
Connect DOP1, DOP2, and UC probes at the left side of the device. There are 2 Doppler probes
and you may connect them to any one of the DOP1, DOP2 and UC Terminals. When diagnosing Error Codes
twin fetus, connect both terminals. -E1 : Paper Out during printing
-E2 : DOP1 Probe is disconnected during using
■Basic Screen by Probe Connection -E3 : DOP2 Probe is disconnected during using (If “E2” error occurs, it will not be displayed)
If the DOP Probe is not attached, nothing shows on the screen where the heart rate is displayed, -E4 : UC Probe is disconnected during using (If “E2” or “E3” errors occur, it will not be
and no sound or heart symbol signal shows. displayed)
-E5 : Low Battery (If “E2”, “E3” or “E4” errors occur, it will not be displayed)
If the DOP Probe is attached but not used, the status is Stand-By, and heartbeat area shows “---”
until the diagnosis starts. When the diagnosis starts, the calculated heartbeat shows on the screen.
If heartbeat is under 50 or heartbeat sound cannot be measured, heartbeat area shows “---”.
If the heartbeat displayed on screen goes over or under the alarm level limit, an alarm will sound
and alarm lamp will change green to red and FHR value will be twinkled.
Also, if the probe line is cut or the probe has been pulled off from the machine, and if it is disabled
during usage, each of the FHR on the FND will show “---”. “PRO OFF” and “d-1”, “d-2”, “UC”
will displays by turns in the maximum/minimum alarm level FND. The error code will also
displays in the Auto Print FND. And information sound(ding dong ding dong) will be heard.
■FHR Measurement (3) When using the belt to fasten the probe, make sure it does not slip.
(1) Touch the patient’s belly and search for the fetus°Øs back and place the DOP Probe. If the As shown above, the probe cable going up in the direction of the patient’s head can prevent
fetus is positioned facing left or right, place the probe as shown on the picture. damage to the cable and the probe does not move as much.
(4) It is important to apply ample amount of Supersonic gel on the probe surface to get rid of air
bubbles in between the abdomen and the probe.
(5) BFM-900L uses a Button-Top styled DOP Probe. Insert the protruding buttons on the opposite
side of the DOP Probe surface to the Button-Hole on the belt under the patient.
(6) It takes 4 to 5 seconds for the heartbeat to show. Once a stable heartbeat is displayed the
printing begins.
■UC Measurement
UC measurement uses an external attachable pressure sensor. Once the UC Probe is placed on the
patient’s abdomen, the pressure fluctuation of the patient°Øs uterus enables the contraction level.
The purpose of the marking is to record the moment when the patient senses the start of the fetal
movement. When you press the Mark switch during printing an arrow shows on the printing
paper. Mark Jack is connected to the left connection terminal of the device.
■ Auto Operation
(1) Control the print time. Print time is set by 10min, 20min, 30min, 40min, 50min, 60min and
off. If you use “OFF”, it will stop printing by press the “Print” button or out of paper.
(2) After finishing the setting by users, it will apply to the initial printing. This setting applies to During printing, you cannot change the printer setting. If you want to change the setting, you
the “AUTO PRINT” area. This setting value is displayed the remained operation time. should stop to print.
Changed setting value without ZOOM is not changed even though you turn off the system.
Zoom is initialized after turning off.
■ FHR 2 Offset Operation
(1) Using 2 Probes simultaneously to measure FHR 1, 2, and the value comes out similar is when
it’s most effective. The Offset draws a graph by increasing +20bpm from the FHR 2 value.
(2) Before using the printer, use the “Up/Down/Enter” key to turn the Offset On. ■ Reading the Recorded Sheet
(3) Once the “Offset : On” status is confirmed, another 20 is added to the FHR 2 value. After Press the “Print” key once to begin recording and the sheet ejects as described below.
finishing the setting by users, it will apply to the initial printing.
The recording areas are divided into two main categories - the text area and the graph area. The
text and graph show as soon as the printing begins. The text is repeated at paper top area on 10
■ ZOOM Operation
minute and is included the setup value of print-(1) Date (2) Time (3) Status of DOP 1, DOP 2
(1) Use this function when you want to see the changes in the FHR more closely.
Probe and UC Probe (4) Status of FM (5) Print Speed (6) Status of Offsset and (7) Status of
(2) When you select “On” in the “Zoom” category in the Print Setup, the FHR area is expanded
ZOOM.
about 105 ~ 200 BPM than the normal range. After finishing the setting by users, it will apply
to the initial printing.
5.8 Volume Control (6) Press the Enter key( ) or Exit key( ) at the desired level and the volume control
operation is complete. If you press the Enter key, the desired level will be saved and move to
The volume can be adjusted in 8 levels and there are two ways to control it. One is to use the SETUP menu (3). If you press the Exit key, the volume level will be returned to previous level and
key( ) and control it from the menu, and the other is to use the volume key( ). The move to menu (2).
volume of Doppler I and II can be adjusted.
(7) You can change the volume level of DOP1 and DOP2 with process (2) ~ (6).
■Volume Change in the Menu (8) Press the Exit key( ) and move to the basic screen after all setting.
(1) Press the SETUP key( ) to move the menu setting mode.
■Using the Volume Key
(1) Press the Volume key( ) to move to menu setting mode. The initial setting is to control
DOP 1. If you press the Volume key once more, DOP 2 will be controlled. DOP 1 and DOP 2
are will be changed by the Volume key.
(2) Adjust the volume to use Up/Down key( ) after choosing DOP 1 or DOP 2. DOP 1
or DOP 2 can be adjusted to repeat process (1) and (2).
(3) Press the Enter key( ) or Exit key( ) at the desired level and the volume control
(3) Press the Enter key( ) to enter the volume control area. operation is complete. If you press the Enter key, the desired level will be saved. If you press
the Exit key, the volume level will be returned to previous level.
The Volume of Key Sound, Alarm Sound and Information Sound cannot be adjusted. If the
(4) Press the Up/Down key( ) for changing the volume HR1 or HR2 and then press the alarm sound happens, you can turn off the sound to use SILENCE key. If the information
Enter key( ). The volume level will be twinkled in the “LOW” area. sound happens, you can turn off the sound to use Exit key.
(5) Press the Up/Down key( ) to control the volume during twinkling.
1) By default the Alarm function is On when you turn the Power on. (1) Doppler Sound : This is the Doppler sound of the fetus’s heartbeat. The volume of this sound
can also be adjusted using the Volume Key.
2) When the values go over or below the Alarm range the beep will sound. The user can stop the (2) Alarm Sound : When a measured HR value exceeds the set range the beep will sound
alarm. Press the “SILENCE” on the front of the device and the beep does not sound for 3 repeatedly.
minutes. If you press the “SILENCE” two times, the beep does not sound until press the (3) INFORMATION : When a probe is disconnected or the battery is low, or the printer door is
“SILENCE”. “AL OFF” will be displayed during the silence situation. ajar, and when the printing paper is missing, a “ding dong” sound will repeat.
(4) The alarm sound and information sound cannot be adjusted.
5.11 AST(Optional)
This function is for waking up the baby. BFM-900L is designed to use AST to connect DOP 2
Probe connector. BFM-900L shows “AST” on the FHR2 area.
- Display during the silence for 3 minutes(Below screen will be displayed in rotation)
Press the button on the AST probe on the patient°Øs abdomen. It makes sound for waking up the
- Display during the silence
baby. Please do not close this device to the ear. It makes you harmful.
CHAPTER 6 Setting by Menu Function Step 3) Press the Enter key( ) on the item desired to be set. Then, each relevant setting
screen will be displayed.
The setting screen will be described in more detailed later.
Menu cannot be set on the volume control mode.
Step 2) Press the Up/Down key( ) to move to the menu in the menu setting mode.
Move to the Record, Alarm, Volume and Time. Step 5) Press the Enter key( ) in Step 4 and desired the level will be twinkled.
Then press the Up/Down key( ) for changing the level.
Step 6) After setting is completed, if press the Exit key( ), menu will move to previous mode
(Step 2) without saving. If press the Enter key( ), menu will move to previous
mode(Step 4) with saving.
Step 7) After all setting is completed, press the Exit key( ) to move to the basic screen.
6.1 Record Setting Step 1) Press the Setup key( ) to move to menu setting mode in the basic screen.
If you press the Exit key( ) , menu will return to the basic screen.
Possible to set the printer relevant works
Step 2) Press the Up/Down key( ) to move to the Record menu in the menu setting mode.
Symbol Description Setting Range
Auto Print Automatically records during the set time 10, 20, 30, 40, 50,
while printing 60, OFF min
Initial setting : OFF
Step 4) Press the Up/Down key( ) to move to desired setting mode among Auto Print,
Zoom Extends FHR recording area of PRINT ON, OFF Offset, Zoom, Speed, Contrast and Fetal Movement. If press the Exit key( ), menu
record paper. If this function is selected, Initial setting : OFF
will move to the previous mode(Step 2). If press the Enter key( ), menu will move to
FHR area of the record paper will change
from the range of 50 ~240bpm to the the detailed setting mode of each mode.
range of 105~200bpm.
Fetal Movement
Print Fetal Movement ON ,OFF
Initial setting : ON
Step 1) Press the Setup key( ) to move to menu setting mode in the basic screen.
If you press the Exit key( ) , menu will return to the basic screen.
Step 2) Press the Up/Down key( ) to move to the Alarm menu in the menu setting mode.
Step 3) Press the Enter key( ) to move to the detailed setting mode.
Step 4) Press the Up/Down key( ) to move to desired setting mode among Auto Print,
Step 5) Press the Enter key( ) in Step 4 and desired the level will be twinkled. Then press the
Offset, Zoom, Speed, Contrast and Fetal Movement. If press the Exit key( ), menu will
Up/Down key( ) for changing the level. Refer to the above setting range in the table.
move to the previous mode(Step 2). If press the Enter key( ), menu will move to
the detailed setting mode of each mode.
Possible to set the volume level for DOP1 and DOP2 respectively
Step 6) After setting is completed, if press the Exit key( ), menu will move to previous mode
(Step 2) without saving. If press the Enter key( ), menu will move to previous
Step 1) Press the Setup key( ) to move to menu setting mode in the basic screen.
mode(Step 4) with saving.
If you press the Exit key( ) , menu will return to the basic screen.
Step 7) After all setting is completed, press the Exit key( ) to move to the basic screen.
Step 2) Press the Up/Down key( ) to move to the Volume menu in the menu setting mode.
Step 3) Press the Enter key( ) to move to the detailed setting mode.
Step 4) Press the Up/Down key( ) to move to desired setting mode among Auto Print, Offset,
Zoom, Speed, Contrast and Fetal Movement. If press the Exit key( ), menu will move
to the previous mode(Step 2). If press the Enter key( ), menu will move to the
detailed setting mode of each mode.
Step 7) After all setting is completed, press the Exit key( ) to move to the basic screen. HOUR Sets hour 0 ~23 hour
MINUTE
Step 1) Press the Setup key( ) to move to menu setting mode in the basic screen.
If you press the Exit key( ) , menu will return to the basic screen.
Step 2) Press the Up/Down key( ) to move to the Time menu in the menu setting mode.
Step 5) Press the Enter key( ) in Step 4 and desired the level will be twinkled.
Step 3) Press the Enter key( ) to move to the detailed setting mode.
Then press the Up/Down key( ) for changing the level.
Step 4) Press the Up/Down key( ) to move to desired setting mode among Auto Print, Offset,
Step 6) After setting is completed, if press the Exit key( ), menu will move to previous mode
Zoom, Speed, Contrast and Fetal Movement. If press the Exit key( ), menu will move to the
(Step 2) without saving. If press the Enter key( ), menu will move to previous
previous mode(Step 2). If press the Enter key( ), menu will move to the detailed
mode(Step 4) with saving.
setting mode of each mode.
Step 7) After all setting is completed, press the Exit key( ) to move to the basic screen.
Step 1) Press the Print key( ) + UC REF key( ) at once in the turning the device off condition. Error Code
Step 2) Turn on the device with pressing the above keys. All basic parameter except for time is Code Description
initialized. If initialized, the screen will be like below. E1 No paper or paper out during printing
When the values go over or below the Alarm range over 10 seconds, the beep will sound. The
Step 3) Then turn on the device without pressing the keys. All parameter is initialized. color of alarm LED lamp will be changed green to red. The FHR will be also twinkled.
If you want to turn off the alarm, press the SILENCE key.
① The beep sounds once like “ding dong” as information sound when turn on the device.
② The beep sounds “ding dong” every 5 minutes when no paper until error is released or press - Probe is disconnected with silence for 3 minutes : Display “AL oFF” and “3 MI” with error
the Exit key. Error message will be displayed in Hi/Low and Auto Print FND until error is code by turns.
released.
③ The beep sounds “ding dong” every 5 minutes when probe is disconnected during using until
error is released or press the Exit key. Error message will be displayed in Hi/Low and Auto
Print FND until error is released.
④ The beep sounds “ding dong” every 5 minutes when the battery is low until error is released or
press the Exit key. Error message will be displayed in Hi/Low and Auto Print FND until error
is released.
⑤ Display for each error
- Probe is disconnected during using : Display “Pro oFF” and “d-1”, “d-2”, “Uc” with error
code by turns in each disconnected probe.
- Probe is disconnected with silence : Display “AL oFF” with error code.
- Probe is disconnected with paper out and silence for 3 minutes : Display “AL oFF” and “3
MI” with error code by turns.
- Probe is disconnected with no paper : Display “ PAP oUt” and “Pro oFF” with error code by turns.
50 Solution for precaution and warning Solution for precaution and warning 51
FETAL MONITOR (Ver 1.1) BFM-900L
- Probe is disconnected with paper out and silence : Display “AL oFF” with error code by turns. - Paper out with silence : Display “AL oFF” with error code
- Low Battery : Display “bAt Lo” with error code(if internal batter is instlled : optional)
- Paper out : Display “PAP oUt” and “Ins Ert” with error code by turns.
If no management with low battery within 10 minutes, the device will be turned off. Before
turning off the device, connect AC power and charge the battery. If the device is turned off
with low battery message, the device will not be turned on before connecting the AC power.
- Paper out with silence for 3 minutes : Display “AL oFF” and “3 MI” with error code by turns.
52 Solution for precaution and warning Solution for precaution and warning 53
FETAL MONITOR (Ver 1.1) BFM-900L
CHAPTER 8 Power
If the device is not operating with battery, please do not open the device. It does not replace
BPM-900L is powered on by both AC/DC. It is powered on by AC basically. It is also powered the battery from the external. Do not dispose the battery in any dangerous place for
on by DC Battery(Optional) while being carried. environmental protection.
8.1 AC Power
When the AC Power is connected to the device the AC Power LED on the front of the device will
show a green light. If the device is not in use, it will revert to auto charge mode. If the battery is connected by AC power, LED for AC power will be lit and the battery will be
charging automatically. When charging is finished, BFM-900L will be finished charging
8.2 BATTERY Power (Optional) automatically.
When you turn the power on without the AC Power connected, the device uses the battery to
operate. When using the battery, the BATTERY LED will show a green light.
When the internal charge level of the battery is under 10.0V, an information alarm will sound and
“bAt Lo” will display on the “Hi/Low, Auto Print” FND. If no management with low battery
within 10 minutes, the device will be turned off. Before turning off the device, connect AC power
and charge the battery. If the device is turned off with low battery message, the device will not be
turned on before connecting the AC power.
54 Power Power 55
FETAL MONITOR (Ver 1.1) BFM-900L
This chapter covers simple troubleshooting methods. You may sometimes not be able to control Mechanical
the device as you want or may not know what to do with the device while using the device. At this Base Unit Size : 180mm(W) x 248 mm(H) x 175 mm(D)
moment, check the followings instead of thinking “It’s broken” Weight : less than 3.7Kg (with paper)
58 Specification Specification 59
FETAL MONITOR (Ver 1.1)
Warranty
Seller
Manufacturer