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Head Office/Factory

214-3, Sangoan-ri, Hongcheon-eub, Hongcheon-gun,


Gangwon-do, Korea (zip.250-804)
Tel : +82-33-434-9041 Fax : +82-33-434-9043
Seoul Office/R&D
#2201 Masters Tower, 553, Dohwa-dong, Mapo-gu,
Seoul, Korea, 121-040, Republic of korea
Tel : +82-2-3275-5420 Fax : +82-2-3275-5425
Customer Service Dept.
Tel : +82-2-3275-5422 Fax : +82-2-3275-5425
Operation Manual

BFM-800
FETAL MONITOR Ver 1.1
OPERATION MANUAL

BFM-800
FETAL MONITOR Ver 1.1
Table of Contents
Instruction

General 3
Warranty Period 4
Request for Services 5
How to Contact Us 6

1. How to Use this Manual


1.1 Contents of Manual 7
1.2 Manual Composition 7
1.3 Meaning of Symbols used in this Manual 8

2. Operational Do s and Don ts


2.1 Don ts in Operational Environment 9
2.2 Cautions for Electrical Safety 11
2.3 Equipotential Connection 12
2.4 Maintenance and Cleaning 12

3. Description of BFM-800
3.1 Characteristics and Principles of BFM-800 14
3.2 Composition of Equipment 14
3.3 Part Names 15
3.4 Description of Equipment Symbols 17

4. Installation of BFM-800
4.1 Cautions for Installation 18
4.2 Installation of Main Equipment 18
4.3 Connection of Cable 20
4.4 Inserting of Print Paper 20

5. Basic Operation of BFM-800


5.1 Pre-Operation Check Points for BFM-800 22
5.2 How to use BFM-800 22
5.3 Initial Screen 23
5.4 Key 24
5.5 FHR Measurement 25
5.6 UC Measurement 28
5.7 FECG Measurement 30
5.8 Event Marker 32
5.9 How to use Print 32
5.10 Control of Sound Volume 34
5.11 Alarm On/Off 35
5.12 Sound 35

6. Setup by Menu Key


6.1 Alarm Setup 37
6.2 Print Setup 38
6.3 Date and Time Setup 39
6.4 Volume Setup 40
6.5 Selection of Probe 41

7. Central Function(Option)
7.1 Installation of Central Function 42
7.2 DTE_TCP Setup 43

8. Power Supply
8.1 AC Power Source 44
8.2 Battery Power 44
8.3 Battery Specifications 44

9. Troubleshooting 46
10. Product Specifications 48
BFM-800

INTRODUCTION

General

Thank you for using BFM-800 (Fetal Monitor). Please read this User s Manual carefully before
operating this equipment for proper handling and maintenance. It is wise to become familiar with
all the functions and features of the equipment, to ensure safe handling and reliable performance.

Please, try to fully understand the features, operation and maintenance methods of this equipment
prior to the actual operation by thoroughly reading this manual. This is the only way to ensure safe
operation and reliable performance of the equipment for a long period of time. BIONICS Corp.
only provides reliable products to our customers.

All of assembling, extending, adjusting or repairing of this equipment shall be carried out only
by the service personnel authorized by either our company or BIONICS Corp. itself.
Electrical connection or installation location has to comply with relevant regulations. The
equipment has to be operated in accordance with the User s Manual.
Operation of this equipment must be as directed in this manual.

This equipment has to be operated under the supervision of licensed medical professionals.
This equipment is used to monitor the conditions of the fetus. To insure the safety of the fetus and
mother, use only the parts and accessories recommended by BIONICS Corp.
In the event that this equipment needs to be used in accordance with other equipment that is not
listed in this manual, be sure to notify us or our authorized dealers about this intent.

General 3
FETAL MONITOR

Warranty Period

Our products are produced through strict quality control and inspection processes. The
compensation standards in terms of repairing and exchange policies for our products complies
with the Compensation Regulations for Consumers issued by the Economic Planning Board
of the Korean Government.
The warranty period for this product is specified to be one year.
If the equipment malfunctions during the course of normal operation while under the warranty
period, it will be repaired without any cost to the customer at one of our Service Centers.
If the equipment malfunctions during the warranty period, please inform the service personnel
on the basic facts, such as model name, product No., purchase date, and a brief description of
the problem.
BIONICS or the local distributor will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions or other information which will assist your
appropriately qualified technical personnel to repair those parts of equipment which are
designated by BIONICS repairable.

4 Warranty Period
BFM-800

Request for Service

Service on BIONICS products can be performed only by the personnel authorized by the
Customer Service Dept. of BIONICS Corp. or by BIONICS itself. In the event that the product is
serviced or tried to be serviced by an unauthorized third party during the warranty period, the
warranty shall be nullified. The Customer Service Dept. of BIONICS or the authorized dealers are
obliged to provide the services requested by the customers. When any abnormalities are found in
the equipment or when a danger to bodily harm exists, the equipment must be repaired
immediately and adequately by authorized personnel.

At times of equipment malfunctions, please take following steps.

Immediately contact our Customer Service Dept. or local distributor. Please be prepared to give
the receiver the model name, product No., purchase date, and a brief description of malfunction
or enquire before making a call.
Our staff in the Customer Service Dept. will first try to analyze and solve the problem while
talking to the customer on the phone, if possible. And for the complicated problems which
cannot be dealt with over the telephone, we will provide on the site service as quickly as
possible.

Request for Service 5


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How to Contact Us

Contact us at following phone numbers for product and order enquiries and service requests. Do
not hesitate to call us for any inquiries. We are here to help you.

Product & Order Enquiries


BIONICS Corp. - Tel +82-2-3275-5422

Service Request
BIONICS Corp. -Tel +82-2-3275-5422
When requesting a repair service, please have ready the product s model name, product
serial No., and a brief description of the problem when contacting our Customer Service
Dept.

6 How to Contact Us
BFM-800

CHAPTER 1 How to Use this Manual

1.1 Contents of Manual

This manual contains all the information needed to operate our Fetal Monitor, BFM-800,
which has been designed by giving the utmost consideration on the users convenience, and it
provides exact information on the conditions of the fetus including the measured values such
as fetal heart rate, and uterine contraction.
Because the chapters in this manual are constructed so that each chapter can be used
independently, some contents may appear in more than one chapter.
This manual is written to help users effectively operate BFM-800. Each feature of this
equipment could be used more effectively, if relevant medical books are referenced for a
clearer understanding of clinical meaning and pathology.
In case some problems occur during the operation of our products, please contact our
company or the A/S Dept. of our contracted A/S company.

1.2 Manual Composition

Users have to carefully read this manual before operation of the equipment.
This manual consists of the various chapters :

Chapter 1. How to use this Manual.


Chapter 2. Operational Do s and Don ts
Chapter 3. Description of BFM-800
Chapter 4 . Installation of BFM-800
Chapter 5 . Basic Operation of BFM-800
Chapter 6 . Setup by Menu Key
Chapter 7 . Central Function (Option)
Chapter 8 . Power Supply

How to Use this Manual 7


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Chapter 9 . Troubleshooting
Chapter 10 . Product Specifications

1.3 Meaning of Symbols used in this Manual

Symbols are used to emphasize the agreed details as follow. Users need to specifically follow all
the cautions and notes listed in this manual.
In the event that the product is damaged due to misuse or negligence by the user, the
manufacturer or the authorized dealers shall not be responsible for any damage or loss to the
product.

The title “Warning” is used to inform the users of possible causes that could inflict injury,
death, or property damage to the patient.

The title “Caution” is used to inform the users of possible causes that could inflict injury to
the patient although it might not be severe enough to cause death.

The title “Note” is used to inform the users of items that are of importance in terms of
installation, operation, or maintenance of the equipment although failure does not inflict
bodily harm to the patient.

8 How to Use this Manual


BFM-800

CHAPTER 2 Operational Do’s and Don’ts

2.1 Don t in Operational Environment


Do not operate or store the equipment under the following environments.

Avoid damp locations, and do


not operate the equipment with Locations where the machine is
wet hands. exposed to direct sunlight.

Locations where the temperature


fluctuation is rather large. Locations close to electrical
(Operational temperature range: heating apparatuses.
10~40 (C, Moisture level : 30~85%)

Locations where moisture level


increase considerably or where Locations where sudden impact
air is not ventilated properly. or vibration could be received.

Operational Do’s and Don’ts 9


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Locations exposed to chemical Make sure to prevent dust, especially


or explosive gases. metal debris, from penetrating in.

Disassembling of equipment Do not plug in the power unit,


should be done only by authorized until installation is completed,
personnel, otherwise we will not be otherwise, damage may be
required to provide, any services. caused to the equipment.

When pulling out the power cord,


be sure to hold the plug and pull,
not the cord.

Standard operational conditions are as follows:


Temperature : 10 ~ 40
Pressure : 70 ~ 106KPa
Humidity : 30% ~ 85%

Standard storage and transportation conditions are as follows:


Temperature : -10 ~ 60
Pressure : 70 ~ 106KPa
Humidity : 20% ~ 95%

10 Operational Do’s and Don’ts


BFM-800

2.2 Cautions for Electrical Safety

Prior to operation of the equipment, make sure to check the following items:
The power supply is appropriate. (100 - 240Vac).
Connections (power line or selected equipment) are properly made to the equipment. For
proper connections, refer to Chapter 4.
The equipment is properly grounded. (If not, some noises could be generated.)
The proper measuring accessory for the desired parameter is connected to the equipment prior
to the turning on of the equipment.

The equipment should be placed far from a generator, X-ray equipment broadcasting
equipment or transmitting wires, so as to prevent electrical noises from being generated
during operation. When these devices are near the equipment, it can produce inaccurate
measurements. For BFM-800, both independent circuit and stable grounding are essential
requirements. In the event that the power source is shared with other electronic equipment,
inaccurate outputs may result.

BFM-800 is classified as follows. :


- Type of protection against electric shock;
Class I equipment
Internally powered equiment(Lead-Acid Battery : manufactured by Volta Ind., Type :
VT1202, Rated 12Vd.c. 2Ah)
- Degree of protection against electric shock
Type CF applied parts : DOP probe, UC porbe, FECG electrode, Event mark
- Degree of protection against ingress of water
Ordinary equipment
- Sterilization or disinfection : refer to cl. 2.4 of operation manual
- The noise level is A Class according to the IEC/EN 60601-1(Safety of Electric Medical
Equipment), and the noise reduction is B Level according to the IEC/EN 60601-1-2
(Electromagnetic Compatibility Requirements).

Operational Do’s and Don’ts 11


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Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g. IEC 950 for data processing equipment and
IEC 601-1 for medical equipment). Furthermore all configurations shall comply with the
system standard EN 60601-1-1:1993. Everybody who connects additional equipment to the
signal input part or signal output part configures a medical system, and is therefore
responsible that the system complies with the requirements of the system standard IEC 601-1-
1:1993. If in doubt, consult the technical service department or your local representative

2.3 Equipotential connection.

In the hospital, doctors and patients are expose to dangerous, uncontrollable compensating
currents. These currents are due to the potential differences between connected equipment and
reachable conducting parts often in the medical rooms. The safety solution to the problem is
accomplished with consistent equipotential bonding. Medical equipment is connected with
connecting leads made up of angled sockets to equipotential bonding network in medical rooms.

12 Operational Do’s and Don’ts


BFM-800

2.4 Maintenance and Cleaning

BFM-800 and its accessories(including probes) can be cleaned using various methods. Please
follow the methods listed below to avoid unnecessary damage or contamination to the equipment.
In the event that harmful (unauthorized) materials are used for cleaning, the damaged or
contaminated equipment shall not be serviced without charges regardless of warranty period.

Please check carefully both frame and sensor after cleaning the equipment. Do not use
equipment that is worn or damaged.

At least once a month, clean and wipe off the frame by using a soft cloth after wetting it with
lukewarm water and alcohol. Do not use lacquer, thinner, ethylene or oxides, which could be
harmful to the equipment. Make sure both cables and accessories are free of dust or contaminants,
and wipe them off with a soft cloth wetted with lukewarm water(40 / 104 ), and at least once
a week, clean them by using clinical alcohol. Do not submerge the accessories in any liquid or
detergent. Also, make sure any liquid is not to get into the equipment or probe.

Place the system far from power generators, X-ray machines, broadcasting stations, and
transmission lines to avoid electrical noise during scanning. Close proximity to such items
may result in abnormal output. An independent circuit and a safety grounded outlet are
strongly recommended for the BPM-800. Poor or abnormal output may occur if the system
shares a power source with other electrical or electronic equipment.

Do not dispose of used probes into any hazard place. Always consider environmental
contamination.

There is real time clock which contains an internal battery inside of the chip. When users
dispose of this chip, please dispose of waste in the proper place for environmental protection.
DS12C887 real time clock.

Operational Do’s and Don’ts 13


FETAL MONITOR

CHAPTER 3 Description of BFM-800

3.1 Characteristics and Principles of BFM-800

BFM-800 is the fetal monitor that measures the fetal heart rate and uterine contraction. BFM-800
irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the doppler
frequency signal reflected from the heart of the fetus. BFM-800 analyzes this signal and displays
the waveform of the heart rate in the printer. Also, BFM-800 provides the sound from the heart of
fetus. During delivery, BFM-800 can measure the heart rate of fetus with the FECG electrode.
Also BFM-800 can measure the uterine contraction of a pregnant woman with pressure sensors
and display in waveform along with numerical values. This waveform informs the period and
magnitude of the uterine contraction. BFM-800 displays the various information(HR, UC) of a
fetus and mother in real time on LCD with numerical values. The user can set up or adjust the
setup values by using the keys in the front, such as setting alarm. BFM-800 can measure the
condition of twins and provide the user with the Central System through the use of an optional
Ethernet Card.

3.2 Composition of Equipment

Standard Accessories
- Ultrasound Probe (DOP I, DOP II )
- UC Probe
- Event Mark Jack
- Printer Paper (2EA)
- Power Code (1EA)
- User s Manual (1EA)
- Ultrasound Gel
- Probe Belt (3EA)
- Accessory Case
- Probe Holder
- Wall Mounted Panel
- Ground Cable

14 Description of BFM-800
BFM-800

Options
- FECG Probe
- Central Cable/Ethernet Card/Interface Program
- Cart

3.3 Part Names

Front & Operation Panel

LCD Display Panel Up Key


ALARM On/Off Key UC Reference Key
Menu Key Print Key
Down Key Mark Jack & Connector
FECG Probe & Connector UC Probe & Connector
DOP II Probe & Connector DOP I Probe & Connector
A/C & Battery Power LED Power Switch
Print Door

Description of BFM-800 15
FETAL MONITOR

Right Side

(1) Power Port


(2) Grounding Port
(3 ) LAN Port

In order to avoid electrical shock, do not open the cover. Disassembling of the equipment
must be done only by service personnel authorized by BIONICS Corp.

User must pay attention to the connection to LAN port. Always consider the summation of
leakage current and consult with your hospital biomedical engineer if in doubt.

16 Description of BFM-800
BFM-800

3.4 Description of Equipment Symbols

Type CF equipment.

AC Power supply port

Attention, consult accompanying documents

Equipotentiality

Signal output port for central monitoring system

Power stand-by switch

Operation by AC Power

Operation by Battery

Volume

Alarm

UC Reference

Menu

Record

Description of BFM-800 17
FETAL MONITOR

CHAPTER 4 Installation of BFM-800

4.1 Cautions for Installation

While installing BFM-800, observe the following points:


- BFM-800 has to be used under surrounding temperatures of 10 ~ 40 and humidity of
30 . ~ 85%
- Check the connection with power cord.
- Do not plug in cords of other equipment and the cord of BFM-800 into the same port
- Place the frame on the horizontal surface.
- In case noise is generated, ground the equipment.
- Do not use the electrical cord if it generates connection noise.
- Prevent probe from outside impacts and don t put probe in water or oil.
- Use the ultrasonic gel when using doppler probe. After use, clean the probe and keep it in a clean
place.
- Handle the equipment with care, the equipment can be easily damaged by sudden impacts.
- Place it in a clean place without dust or combustible materials, and check the surrounding
temperature and humidity.
- All the setup values are stored in the inner memory space even after the equipment is turned off.

4.2 Installation of Main Equipment

A. Installation on the Table


In the situation of installing BFM-800 on an ordinary table, connect the accessory case with the
back of the equipment. Align the groove at the back of the equipment with the linker of the
accessory case. Push the accessory case from the bottom to the top to fit them together. On the
contrary, in the situation of separating them, pull the accessory case from the top to the bottom.

18 Installation of BFM-800
BFM-800

The Back of the Equipment The Front Side of the


Accessory Case

B. Installation on the wall


In the situation of installing on the wall, attach the wall mounted panel to the wall with a nail.
Then, divide the accessory case in three panels and assemble them as below(see figure). Install the
equipment on the connecting equipment panel.

Wall Mounted Panel

Connecting The Back of the


Equipment Panel Equipment

Supporting Panel

Accessory Case

C. Installation on the CART(Option)


Refer to user s manual of the CART.

Installation of BFM-800 19
FETAL MONITOR

4.3 Connection of Cable

1) Power Connection
Plug in the power cable into power port of BFM-800.
2) Connection between the main Equipment and Probe
- Connect the desired probe to the appropriate connecting ports on the bottom of the
equipment.(Refer to below figure.)
- Malfunction may occur, if connection is not proper.

3) Connection of Ground Cable Connect the grounding port of the equipment with the earth
terminal at the site of installation.
4) Connection of LAN Cable(Option) Connect the LAN port of the equipment with the LAN port
at the site of installation.

4.4 Inserting of Print Paper

- Push the top door of the equipment upward to insert the printer paper as in figure below.
- Pull the bottom door towards the front. The space for the printer and the printer paper is then
evident.
- Lift up the grip of the right side of printer to insert print paper into the black roller of printer.
- Insert the paper into roller of printer. The surface to print adjoins the

20 Installation of BFM-800
BFM-800

bottom and 240 ,the heart rate scaled paper, should be placed at the left of the printer.
- Draw the paper 4~5cm and lower the grip of printer to fix the paper.
- Attention! Lower the grip of printer with inserting paper into printer. Otherwise, the thermal
head of the printer may be damaged.
- Close the bottom door. The top door slides down automatically.

Please turn off the power switch to prevent malfunction when replacing paper.

Installation of BFM-800 21
FETAL MONITOR

CHAPTER 5 Basic Operations of BFM-800

5.1 Pre-Operation Check Points for BFM-800

Check the following items for the equipment and measuring module, beforeoperating the
equipment.
Check whether there exists any mechanical danger.
Inspect the lead that connects it to outside, the power plug, and accessories.
Check all the measuring instruments required to monitor the fetus.

5.2 How to use BFM-800

First, connect the probe to use with the equipment. Generally, connect the probe as follows :
- Antipartum Monitoring of only One Fetus : DOP I, UC, Mark Jack
- Antipartum Monitoring of Twins : DOP I, DOP II, UC, Mark Jack
- Intrapartum Monitoring : FECG

Step 1) Turn the power switch on. It will automatically start the self-diagnosis procedure for the
equipment (If an error message appears, refer to Ch9. Solutions to Simple Problems ).
After the self-diagnosis, the equipment is ready to be used.

22 Basic Operations of BFM-800


BFM-800

Step 2) If you want to change the set values while in use, use the keys of the equipment
(refer to Ch.6)
Step 3) Put the probe to measure on the abdomen of a pregnant woman. Fix the probe by fastening
the belt. (refer to 5.5, 5.6, 5.7)
Step 4) Hear the sound of the heart and check the heart rate value displayed on the LCD.
Step 5) Print the value of measurement by record key. (Refer to related items in this manual about
the measuring and setup.)

5.3 Initial Screen

DOP I represents FHR(Heart Rate) I by Doppler probe I.


Heart rhythm of FHR I. If only the outer ring blinks, it illustrates that the HR value is unstable.
8 step volume level of FHR I.
Heart rate(bpm) of FHR I.
It represents the channel(DOP II or FECG) selected as FHR II.
Heart rhythm of FHR II. If only the outer ring blinks, it illustrates that the HR value is unstable.
8 step volume level of FHR II.
Heart rate(bpm) of FHR II.
It represents the UC area.
UC measurement value.
It represents whether or not the printer is operating. The printer symbol comes out under
printing.
It represents alarm ON/OFF. The bell symbol is displayed when alarm has been turned on. On
the contrary, the bell with drawing X is displayed when alarm has been turned off.

Basic Operations of BFM-800 23


FETAL MONITOR

It represents the present time.


This area informs use of a battery short. When the battery is short, the information sound rings
and the battery symbol blinks.
Message area which represents some errors or situation.

5.4 Key

Key of the front

(1) (Volume Up) : Volume Up key of selected module of FHR I or FHR II. During the use
of the Menu for setup, this key is used to move between items of Menu or change the
setting value.
(2) (Volume Down) : Volume Down key of selected module of FHR I or II. During the use
of the Menu for setup, this key is used to move between items of Menu or change the
setting value.

24 Basic Operations of BFM-800


BFM-800

(3) (Alarm) : Alarm On/Off key.


(4) (Reference) : Key setting UC value as reference value(10).
(5) (Menu) : Key for setting up various kinds of function. During printing, Menu key is
used to select module(FHR I or FHR II) controlling the sound volume.
(6) (Record) : Print On/Off Key. While using Menu, the Record key is used to select items
to change and memorize the setting value.
(7) (Power) : Power Switch of the equipment.

Lamp
The LEDs on the lower right of the front panel show the kind of the power used.
(8) (AC Power) : Green LED is turned on when using AC Power.
(9) (Battery) : Orange LED is turned on when using Battery.

5.5 FHR(Fetal Heart Rate) Measurement

To measure FHR, put the ultrasonic gel on the surface of the probe.

Connecting Doppler Probe


Connect Doppler probe with the connector(DOP1 or DOP2) of the bottom of the equipment. If
you want to monitor one fetus, you can use either Doppler probe of the two provided units. But if
you want to monitor twins, above all, you must set FHR II area as DOP II, not FECG. And use
both of the units of the Doppler probe.

Initial Screen according to connecting Doppler Probe


If you don t connect Doppler probe, three hyphens are displayed on the heart rate value area. You
won t hear any sound or see the heart rhythm symbol to represent the beating of heart. Even if
Doppler probe is connected, but you don t use Doppler probe, there will be no sound. And 0 will
be displayed on the heart rate value area. If you begin to monitor the measured heart rate is
displayed on the area and the heart rhythm symbol blinks in synchronism to the beating of heart. If
only the outer ring of the heart rhythm symbol blinks, it represents that the measured heart rate is
unstable. You can hear the beating sound of the heart. The sound volume can be controlled by the
UP/DOWN key.

Basic Operations of BFM-800 25


FETAL MONITOR

If heart rate is beyond the heart rate limit of the alarm, the warning message (Tachycardia or
Bradycardia) is displayed and alarm rings.

26 Basic Operations of BFM-800


BFM-800

During monitoring, if the line of probe breaks down or the probe comes out from the connector,
the message ( DOP I OFF or DOP II OFF ) is displayed and the information sound Ding
Dong is heard.

Measurement of FHR
(1) Touch the abdomen of a pregnant woman and search for the back of the fetus, then, put
Doppler probe on that region. In the case that a fetus lays itself down sideways, put down
Doppler probe as seen in the figure below.

In the case of fixing the probe on the front of a fetus, not the back, brings about an inaccurate
measurement of heart rate owing to unstable signal from the fetus.
When the fetus is heading down-ward or up-ward, you must pay attention to placing the probe.
Put the probe around the navel of the patient.
(2) Moving the probe around slowly, search for the position where you can hear the heart-beating
more clearly, then, fasten the belt after positioning the probe.
Do not push the volume key until you find a correct position with probe. When you position
the probe on the correct area and hear a relatively clearheart-beat and see a FHR rhythm symbol
blinking as per the heart-beat, you can adjust volume key as needed.
(3) Carefully fasten the belt so that probe doesn t slip.

Basic Operations of BFM-800 27


FETAL MONITOR

As shown in the drawing, above you need to arrange the probe up-ward of the patient, to
minimize cable damage and use it more efficiently.
(4) Put the ultrasonic gel on Doppler probe to prevent the attenuation of the ultrasound signal and
remove the bubble between the abdomen and the probe.

(5) BFM-800 uses Doppler probe with the Button-Top form. Stick the button of Doppler probe in
the button-hole of belt to fix Doppler probe.

(6) 4~5 seconds is needed to calculate and display the heart rate. If the stable heart rate is
displayed, start printing.

5.6 UC Measurement

With the help of the belt, the UC probe is used in measuring external uterine contraction. UC
probe is affixed on the maternal abdominal wall and measures UC by the pressure made by
uterine contraction.

Connecting UC Probe
Connect UC probe with the connector(UC) at the bottom of the equipment.
Initial Screen according to connecting UC Probe
If you don t connect UC probe, two hyphens are displayed on the UC value area. If you begin
to measure UC, the value proportionate to the uterine contraction of patient is displayed. During
monitoring, if the line of probe breaks down or probe comes out from the connector, the
message UC OFF! is displayed and the information sound Ding Dong is heard.

28 Basic Operations of BFM-800


BFM-800

UC Measurement
(1) Place UC probe at 10cm upper of navel (fundus) and fasten with belt. If UC probe are placed
at below navel, measurement can be influenced by maternal respiration.
(2) Fasten UC probe with belt. At this time, UC value must show 20 ~ 90.
(3) Push Reference key to make UC value 10 .
(4) When uterine contraction is not occurred, check the place of UC probe again.

After fastening UC probe with belt, you need to push Reference key one time before use.
Afterward, UC reference is automatically setted.
If you want to change UC probe position, you need to try above four steps again.
You must print by pushing Record key after Doppler probe and UC probe are placed at right
position.

Basic Operations of BFM-800 29


FETAL MONITOR

5.7 FECG Measurement (Option)

FECG(Fetal ECG) is measured by using a spiral intradermal electrode. During


delivery(intrapartum monitoring), in the case where measuring ECG directly from the fetus, stick
the electrode into the scalp of fetus. At this time, the fetus should be in the amniotic fluid of uterus,
the amniotic fluid contains many ions which allow electricity to flow.
A intradermal electrode is composed of a plastic tube with a wire and a hook made of stainless
steel. When you stick this electrode into the scalp of fetus, spin and push the electrode, allowing
the electrode to be inserted into the scalp. Once the electrode is stuck into the scalp, this electrode
may not be taken off easily. You need not be worried about serious injury to the fetus, as the
length of hook is short and it isn t inserted deep within scalp. The principle of measuring ECG
uses the electric potential difference between a spiral electrode put in to the scalp of the fetus and a
hub electrode put in the amniotic fluid. Another unit to measure FECG is FECG T r a n s d u c e r.
FECG transducer is used to connect a spiral intradermal electrode and remove signal noise by
putting the reference plate on the mother s thigh.

Connection FECG Transducer with Intradermal Electrode


FECG measurement needs FECG transducer and intradermal electrode. Connect FECG
Transducer with FECG connector at the bottom of the equipment. The other side of FECG
transducer connects to two pieces of wire on the intradermal electrode. The metal plate of FECG
transducer is put on the thigh of a mother and is fastened by a belt.(Hereafter, FECG transducer
and intradermal electrode is called as FECG probe.)

Initial Screen according to connecting FECG Probe


For FECG measurement, you must set the area of FHR II on LCD as FECG. Check if FECG
probe is connected. If not, three hyphens are displayed on the FECG value area. You can not hear
the beeping sound represent the period of heart-beat and heart rhythm symbol.

30 Basic Operations of BFM-800


BFM-800

Even if FECG probe is connected, but if you don t use FECG probe, no sound rings. And 0 is
displayed on the heart rate value area. If you begin to m o n i t o r, the measured heart rate is
displayed on that area and the heart rhythm symbol blinks in synchronism to the beating of the
heart. If only the outer ring of the heart rhythm symbol blinks, it represents the measured heart rate
is unstable. And you can hear the beep sound representing the period of the heart-beating. The
sound volume can be controlled by UP/DOWN key. If the heart rate is beyond the heart rate limit
of alarm, the warning message ( Tachycardia or Bradycardia) is displayed and alarm sound rings.
During monitoring, if the line of probe breaks down or the probe comes out of the connector, the
message FECG OFF is displayed and the information sound Ding Dong is heard.

FECG Measurement

Intradermal electrode is unit for one-time usage only.


Do not use intradermal electrodes that have been used previously.

(1) Connect FECG transducer with the equipment and fix the metal plate of FECG transducer to
the thigh of the mother.

(2) Connect intradermal electrode with the terminal of FECG transducer. (If necessary, refer to the
manual on packing of intradermal electrode.) Push the plug of FECG transducer terminal and
put each wire of the intradermal electrode in the hole of the terminal. The two pieces of wire
from the intradermal electrode may not be put in the same hole.

(3) Check the direction of the spiral of intradermal electrode and stick and affix the electrode into
the scalp of fetus head. Then, the Heart Rate of fetus is displayed on the FHR II area of LCD.
You can hear the beep sound and see the Heart Rhythm representing the period of heart-
beating.

(4) 4~5 seconds is needed to calculate and display the Heart Rate. If a stable Heart Rate is
displayed, start printing.

Basic Operations of BFM-800 31


FETAL MONITOR

5.8 Event Marker

MARKER is used to record the fetal movement perceived by the mother. If a mother presses the
button of Marker, an arrow is printed on paper. MARK JACK is connected with the Mark
connector on the bottom of the equipment.

5.9 How to use PRINT

TLHU112AE24AB Printer of TAMURA Co. is used in BFM-800. It needs a power supply of


24V. The width of printer paper is 112mm.

How to PRINT

(1) If you want to print, Press RECORD key. The symbol which informs the operation of printer
appears below the alarm symbol of the right of LCD. The monitoring measurements are
printed.

(2) During printing, if you want to stop printing, Press RECORD key again. The print symbol
disappears and the operation of the printer stops. At this time, the printer feeds paper 3 ~ 4cm
after stopping the recording.

(3) When you don t use the printer, if you want to feed paper through the printer, press
RECORD key for longer than 2 seconds. As long as you press RECORD key continuously,
the printer will continue to feed paper.

(4) Basically, the graph of FHR II area is printed dimmer than that of FHR II to distinguish FHR I
from FHR II.

32 Basic Operations of BFM-800


BFM-800

(5) If a error message ( “Door Open!” or “Paper Out!” )is displayed on LCD, solve the problem
and print again.
Door Open ! : The grip of printer is lifted up.
Paper Out ! : paper is used up or caught in the roller of printer.

OFFSET of FHR II

(1) When you monitor FHR I, II at the same time, it is hard to distinguish FHR I from FHR II if
the measurements of FHR I are similar to those of FHR II. At this time, the OFFSET function
will help you. If you use OFFSET , FHR II measurement is printed by 20(bpm) added value.

(2) Before printing, set the Offset(+20 in Print setup Menu) as o n b y MENU/UP/DOWN/
RECORD key.

(3) This setting will not be changed even if the power is off. Therefore, if you don t want to use
OFFSET function afterwards, you must change the setup to off

ZOOM

(1) This function enables you to watch the variation of FHR closely.

(2) If you set rng as on in print setup menu, the printing range of FHR(50 ~ 240(bpm)) is
change to 105 ~ 200(bpm). You can see the FHR scale(105 ~ 200(bpm)) of a small size on
paper.

Recording Paper

If you begin to print, the various information regarding the present situation is printed first,
before printing the measurements. This information includes the date, time, Probe On/Off,
print setting, alarm limit, and the information about a mother.

Basic Operations of BFM-800 33


FETAL MONITOR

FHR I, FHR II Area.


Fetal Movement Area.
UC Area.
EVENT MARKER Area.
Area printing the present time per 10 minute.

5.10 Control of Sound Volume

Sound volume is composed of 8 steps and controlled by UP/DOWN key.

When Printer does not operate

(1) If you press UP key, Doppler and FECG beep sound is louder than before. And if you press
DOWN key, Doppler and FECG beep sound is lower than before. You can see the change in
sound in the volume step symbol on LCD.

(2) If sound volume is selected as minimum, sound is turned off.

(3) Only the selected one of FHR I, FHR II is controlled by UP/DOWN key. If you want to
control unselected one, change the setting in sel o f VOLUME Menu. I means FHR I and
II means FHR II in sel

34 Basic Operations of BFM-800


BFM-800

When Printer is operating

(1) Sound volume of selected FHR I and FHR II is controlled by UP/DOWN key.

(2) While printing, you can t use the Menu. Therefore, if you want to change the selection( FHR I
--> FHR II or FHR II --> FHR I), press the Menu key. Then, the selection is changed ( FHR I
--> FHR II or FHR II --> FHR I).

5.11 ALARM On/Off

1) Alarm sound is ready to ring in the initial setting directly after turning on the Power. You can
see the bell symbol on the right of LCD.

2) If the measured Heart Rate is beyond the range of the alarm limit, the alarm rings. In this case,
you can stop the alarm to avoid the continuous ringing. If you press ALARM key, the bell
symbol with drawing X appears on the right of LCD and alarm stops ringing.

3) If you want to ring the alarm again, press ALARM k e y. Then, the bell symbol without X
appears and alarm is ready to ring.

5.12 SOUND

(1) DOPPLER : Doppler sound by the heart-beating of the fetus rings. Doppler sound is
controlled by UP/DOWN key.

(2) BEEP : When monitoring FECG, the beep sound representing the period of heart-
beating rings.

(3) ALARM : If the measured Heart Rate is beyond the range of the alarm limit, the
alarm sound( Bee-Bee-Bee ) rings.

(4) INFORMATION : Information sound( Ding-Dong ) rings when the probe comes off from
the connector during monitoring, if the battery is low, the grip of Printer is
lifted up or the paper is used up.

Basic Operations of BFM-800 35


FETAL MONITOR

CHAPTER 6 Setup by Menu Key

You can change the various settings by the MENU KEY.


- ALARM : HR range to activate alarm.
- PRINT : Setting related to Printer
- VOLUME : Selection of channel to control sound volume and information sound On/Off.
- TIME : Setting of a present date and time.
- CHANNEL : Selection of the Probe(DOP 2 or FECG) of HR II (The figures used in the chapter
6 are based on the equipment with the central function option.)

Step 1) If you press the Menu key on the initial screen, the Menu bar appears on the right of LCD
as the below figure. If you press the Menu key again, the screen returns to the initial
screen. In the Menu screen and setup screen, the Menu key functions as the hot key for the
screen to return to the initial screen.

Step 2) Move the triangular indicator point to the item in which you want to change a setting by
the UP/DOWN key.

Step 3) If you press Record key in the item to change a setting, the setup screen appears.

Step 4) If you press the Record key in the EACAPE item, the screen returns to the initial screen.
The below table illustrates the factory setup value which is set at the time of taking the
equipment out of the factory.

36 Setup by Menu Key


BFM-800

MENU Setting Item DESCRIPTION Setting value


ALARM HI ALARM HIGH LIMIT 190 bpm
LOW ALARM LOW LIMIT 110 bpm
PRINT SPD PRINT SPEED 3 cm/min
CON PRINT CONTRAST 1 step
PRD PRINT AUTO PERIOD OFF
RNG PRINT HR RANGE OFF
+20 PRINT HR OFFSET OFF
Time YEA YEAR
MON MONTH
Present Date
DAT DATE
and Time
HOU HOUR
MIN MINUTE
VOLUME VOL VOLUME DOP
INF INFORMATION ON
CHANNEL HR2 HR CAHNNEL DOP
DTE_TCP IP IP
GW GATE WAY
SM SUB MASK
DNS DNS

6.1 ALARM Setup

A user can set the range to ring the Alarm.

Item DESCRIPTION Range


HI Alarm Occurrence for the faster HR than the setting value 50~240 bpm
LO Alarm Occurrence for the slower HR than the setting value 50~240bpm

Step 1) Make the triangular indicator point to the Alarm Item on the Menu screen, and press the
Record key. Then, the alarm setup screen appears.

Setup by Menu Key 37


FETAL MONITOR

Step 2) Make the triangular indicator point the setup Item(HI, LO) on the setup screen with the
UP/DOWN key, and press the Record Key. Then, the set value is changed to the reverse image.
Step 3) Change the setting value with the UP/DOWN key.
Step 4) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)
Step 5) To return to the Menu screen, select the ESCAPE item( ). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

6.2 PRINT Setup

A user can set the details for the printing operation.


Step 1) Make the triangular indicator point to the Print Item on the Menu screen, and press the
Record key. Then, the print setup screen appears.

Item DESCRIPTION Range


HI The printing velocity 1, 2,3 cm/min
LO The contrast which means the thickness of graph 1,2,3,4 steps
PRD 10,20,30,40,50,
The auto printing period
60, OFF min
The ZOOM function watch the variation of FHR closely.
RNG The printing range of FHR(50~240 (bpm)) is change to ON, OFF
105~200(bpm)
+20
During ‘ON’status, FHR value is recorded by 20 added
ON, OFF
value

Step 2) Make the triangular indicator point to the setup Item(SPD, CON, PRD, RNG, +20) on the
setup screen with the UP/DOWN key, and press the Record key. Then, the set value is
changed to the reverse image.
Step 3) Change the setting value with the UP/DOWN key.

38 Setup by Menu Key


BFM-800

Step 4) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)

Step 5) To return to the Menu screen, select the ESCAPE item( ). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

6.3 Date and Time Setup

A user can set the year, month, date, hour and minutes.
Item DESCRIPTION Range
YEA Year (1900~2099) 1900 ~ 2099
MON Month 01~12
DAT Date 01~31
HOU Hour 00~23
MIN Minute 00~59
Step 1) Make the triangular indicator point to the Time Item on the Menu screen, and press the
Record key. Then, the time setup screen appears.
Step 2) Make the triangular indicator point the setup Item(YEA, MON, DAT, HOU, MIN) on the
setup screen with the UP/DOWN key, and press the Record key. Then, the set value is
changed to the reverse image.
Step 3) Change the setting value with the UP/DOWN key.
Step 4) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)

Setup by Menu Key 39


FETAL MONITOR

Step 5) To return to the Menu screen, select the ESCAPE item( .). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

6.4 VOLUME Setup

Item DESCRIPTION Range


SEL The selection of FHR or FHR to control the volume HR
INFOR Information sound ON/OFF

A user can set the channel(FHR I, FHRII) to control the sound volume.
Step 1) Make the triangular indicator point the Volume Item on the Menu screen, and press the
Record key. Then, the time setup screen appears.
Step 2) Make the triangular indicator point the setup Item(SEL, INFOR) on the setup screen with
the UP/DOWN key, and press the Record Key. Then, the set value is changed to the
reverse image.
Step 3) Change the setting value with the UP/DOWN key.
Step 4) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)

VOLUME

sel : I
infor :
on

Step 5) To return to the Menu screen, select the ESCAPE item( ). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

While printing, you can t use the Menu. Therefore, if you want to change the selection( FHR
I --> FHR II or FHR II --> FHR I), press the Menu Key. Then, the selection is changed ( FHR
I --> FHR II or FHR II --> FHR I).

40 Setup by Menu Key


BFM-800

6.5 Selection of PROBE

A user can select the probe of FHR II. The FHR II area displays the HR from Doppler 2 or FECG.
Therefore, a user must select the probe of FHR II to use. The FHR I area displays the HR from
only Doppler 1.

Item DESCRIPTION Range


FHR II The selection of the probe to use between Doppler2 and FECG DOP II, FECG

Step 1) Make the triangular indicator point to the channel Item on the Menu screen, and press the
Record key. Then, the channel setup screen appears.
Step 2) Make the triangular indicator point the setup Item(FHR II) on the setup screen with the
UP/DOWN key, and press the Record key. Then, the set value is changed to the reverse
image.
Step 3) Change the setting value with the UP/DOWN key.
Step 4) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)

Step 5) To return to the Menu screen, select the ESCAPE item( ). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

Setup by Menu Key 41


FETAL MONITOR

CHAPTER 7 Central Function(Option)

7.1 Installation of Central Function

The central monitoring function of BFM-800 is the user s option. If a user wants to use the
central function, the user must install the DTE_TCP Ethernet Card from our supplier in this
equipment and purchase the central monitoring S/W. At the time of purchasing a BFM-800, if a
user purchases a BFM-800 with the central function option, our company installs the DTE_TCP
Ethernet Card in the equipment.

Check whether the DTE_TCP Card for the central monitoring is installed. You can check it in the
Menu screen. If the DTE_TCP has not been installed, the central function symbol item is not
displayed on the Menu screen, as in the below figure.

If the DTE_TCP has been installed, you can see the central function symbol item on the Menu
screen as the figure below.

42 Central Function(Option)
BFM-800

7.2 DTE_TCP Setup

A user must set the DTE_TCP to connect BFM-800 with the Central Monitor.

Item DESCRIPTION Range


IP Local IP Address 000~255
GW GATE WAY 000~255
SM SUB MASK 000~255
IPR Remote Machine IP Address 000~255

Step 1) Make the triangular indicator point to the central function Item on the Menu screen, and
press the Record key. Then, the central function setup screen appears.

Step 2) Make the triangular indicator point the setup Item(IP, GW, SM, IPR) on the setup screen
with the UP/DOWN key, and press the Record key. Then, the set value is changed to the
reverse image.

Step 3) Make the triangular indicator point to the number to change on the setup screen with the
UP/DOWN key, and press the Record key. Then, the set value is changed to the reverse image.

Step 4) Change the setting value with the UP/DOWN Key.

Step 5) Press Record key to store the setting value. (The setting value is remembered even if the
power is turned off.)

Step 6) To return to the Menu screen, select the ESCAPE item( ). If you don t need to change
other Menu items, press the Menu key to return to the initial screen.

Central Function(Option) 43
FETAL MONITOR

CHAPTER 8 Power Supply

BFM-800 can be operated by both AC and DC power. In addition to the standard AC power
source, BFM-800 can be operated while on the move by getting the power from DC battery.

8.1 AC Power Source

When AC power is supplied to the equipment, the green LED AC power light on the lower right
of the front panel is turned on. And when the equipment is not in use, it is automatically put into
auto recharge mode.

8.2 Battery Power

When the equipment is turned on while AC power is cut off, the power is supplied from the
battery and the orange LED battery power light on the lower right of the front panel is turned on.
- In case battery power is running low: When the battery capacity goes below 11.2V, the
information sound will ring and the low battery message will be displayed and the battery-
shaped icon will blink for a few minutes, and then the power will eventually turn of f . Therefore,
AC power has to be supplied soon enough in order to prevent the power shortage.
- Recharging period : Longer than 15 hours
- Continuous operation time per full recharge : 1 hours

8.3 Battery Specifications

BFM-800 uses a lead acid battery pack. The shelf lives shown on this table are the life spans when
they are not usedat all.

44 Power Supply
BFM-800

Temperature Shelf Life

0 C (32 F) to 20 C (68 F) 12 months


21 C (70 F) to 30 C (86 F) 9 months
31 C (88 F) to 40 C (104 F) 6 months
41 C (108 F) to 50 C (122 F) 3 months

Battery Replacing
The worn-out battery has to be replaced with the same type of battery,
- Type : VT1202 ( Lead-acid battery)
- Manufacturer : VOLTA Industry Co., Ltd.

Battery Replacing Time


Once a battery starts to be used, it has to be used continuously, and when it is completely used
before recharging, the battery life will be shortened. For appropriate battery replacing time, refer
to the following table.

Recharge/Discharge Rate Used Times


100% Recharge/Discharge 200 times
50% Recharge/Discharge 500 times
30% Recharge/Discharge 1200 times

Replace damaged or leaking batteries immediately. Do not use a damaged battery on the
equipment. When AC power is supplied to the equipment, the battery is recharged automatically.
The battery cannot be recharged while being separated from the equipment.

For preservation of environment, do not discard of the batteries in inappropriate places.

Refer to authorized local dealer or BIONICS for the periodical checking or replacement of
internal battery.

Power Supply 45
FETAL MONITOR

CHAPTER 9 Troubleshooting

This chapter explains the solutions to simple problems. One might feel lost sometimes while
operating the equipment. You don t need to call the service Dept. every time you have a problem.
It might be as simple as an operational problem. Before you call for help, please check the
following points.

System

Problem Diagnosis/Solution

Check whether AC power line is qlugged in.


Cannot turn the Power on.
Faulty power switch
Cannot produce the proper Unstable connection
opertaion. Faulty grounding of the equipment

During Doppler HR , UC, or FECG measurement

Problem Diagnosis/Solution

Check whether probe is connected properly.


In case measuring FHR II, check whether DOP II
When “___” symbol appears
mode or FECG mode.
on HR value display area.
If the problem still persists, contact the Engineering
Dept. of Hospital or our Customer Service Dept.

When “DOP I OFF!”, “DOP II


OFF!”, “FECG OFF!”, or “UC Check whether probe is connected properly
OFF!” message is displayed.

46 Troubleshooting
BFM-800

During Printing

Problem Diagnosis/Solution

When “Door Open!” message Check whether the grip of printer is lowered. If the
appears on massage area. grip has been lifted, lower the grip.

Check whether paper is inserted into the roller of


When “Paper Out!” message printer properly. If paper is inserted improperly,
is displayed. correct the place of paper. Or if paper is out, insert
paper.

During Doppler HR , UC, or FECG measurement During Printing

Problem Diagnosis/Solution
When “FAIL” message appears for - contact our Customer Service Dept. or A/S
various initial check. Receptions.

For repair, contact our Customer Service Dept. or A/S Receptions.

Troubleshooting 47
FETAL MONITOR

CHAPTER 10 Product Specifications

Monitor Specifications

Monitor Physical Specifications


Size (W X D X H) : 280 mm X 100 mm X 320 mm (9.45 X 6.69 X 8.86 )
Weight : About 6 Kg (With Battery)

Monitor Environmental Specifications


Temperature Range
Operating : 10 to 40
Storage : -10 to 60
Relative Humidity Range
Operating : 30% ~ 85%
Storage : 20% ~ 95%
Atmospheric Pressure Range
Operating : 70 ~ 106kPa
Storage : 70 ~ 106kPa

Power Specifications
Power Requirements : 100 - 240VAC, 50/60Hz, about 80VA
Power Fail Protection
Battery Specifications : Sealed Rechargeable Battery (12V 2Ah)
Operation Time : about 1 hours
Charge Time (after connection to AC power) : about 15 hours

Monitor Performance Specifications


Doppler
Pulsed Doppler
Ultrasound Frequency : 2.0 MHzIntensity :
Intensity : <10mW/cm2
FHR Range : 50 ~ 240 bpm
FHR Accuracy : 1% of range
Dual Doppler
Dual Fetal Movement Detection

48 Product Specifications
BFM-800

UC
External Type
Frequency Response : DC ~ 0.5 Hz
Reference(Zero) Control
Measurement Range : 0 ~ 99 units
FECG
FHR range : 50 ~ 240 bpm
Input Impedance : >10 M ohm
Input Circuit Current : Less than 50uA
Baseline Recovery Time : Less than 5 seconds
Input Signal Range : 5mVpeak(DC offset : 300mVpeak)
Bandwidth : 0.5 to 35Hz
Printer
Thermal Array Type
Print Speed : 1, 2, 3 cm/min
Print Contrast : 1, 2 ,3, 4 steps
Auto Print Period : 10, 20, 30, 40, 50, 60, off min
FHR Print Area Zoom Function
FHR II Offset Function
Paper Feeding Function
Display
Graphic LCD
Resolution : 128 X 64 pixels
Viewing Area : 83 X 18.6 mm
LED Backlight
3 Channels (HR I, HR II, UC)
Indicators
Heart Rhythm
Signal Quality
Alarm on/off State
Printing State
Operation Channel
Volume State
Low Battery State
Clock Display
Battery On (green LED)

Product Specifications 49
FETAL MONITOR

AC Power (green LED)

Sound
Doppler Sound with Volume Control
FECG beep sound with Volume Control
Information Sound
Alarms Sound

External Link
Ethernet (Central) : Option

Standard Accessories
- Ultrasound Doppler Probe 2 ea
- UC Probe 1 ea
- Event Marker Jack 1 ea
- Print Paper 2 ea
- Power cord 1 ea
- Fuse(1A, 250V) 2 ea
- Ultrasound Gel 1 ea
- Probe Belt 3 ea
- Accessory Case 1 ea
- Probe Holder 1 ea
- Wall Mounted Panel 1 ea
- Ground Cable 1 ea
- Operation Manual 1 ea

Optional Accessories
- FECG Probe
- Cart
- LAN CABLE

50 Product Specifications
BFM-800

Product Warranty

Thank you for using BFM-800.


Only the products that have passed our extensive and thorough quality tests are
offered to our customers.
Our policies on repairing, exchange, and refund complies with “Regulation on
Consumer Protection & Compensation Standards” issued by the Economic
Planning Board of Korea.

Product Specifications 51
FETAL MONITOR

EC Declaration of Conformity
0470
Manufacturers Name : BIONICS Corp.
Manufacturers Address : 214-3, Sangoan-Ri, Hongchun-Eub,
Hongchun-Gun, Kangwon Do
Korea

Declares that the product

Product Name : Fetal Monitor


Model Number : BFM-800
to which this declaration relates is in conformity with the European Directive :

93/42/EEC
“Council Directive of 14 June 1993 on the approximation of the laws of the Member States concerning
medical devices.”

The technical documetation and full compliance with the standard(s) or other normative documents
listed below proves the conformity with the essential requirements of the above-mentioned EC Directive
:

Safety Performance EN 60601-1 : 1990+A1:1993+A2:1995


{IEC60601-1:1988+A1:1991+A2:1995}

EMC : EN 60601-1-2 : 1993 {IEC 60601-1-2 : 1993}

Conducted Emission : CISPR 11 : 1990 : Class A


Radiated Emission : EN 55011 : 1991 {CISPR 11 : 1990} : Class A
ESD : IEC 801-2 : 1991 [CD=3kV : AD = 8kV]
Radiated lummunity : IEC 801-3 : d1992 [3Vm@80% sin. Mod.]
Fast Transients/Bursts : IEC 801-4 : 1998 [AC=1kV; DC=0.5kV:I/O=0.5kV]
Surges : IEC 801-5 : d1993 [DM=1kV: CM=2kV]

Supplementary Information
The devices are Class IIb.
The devices were tested in a typical configuration of a BIONICS BFM-800 Fetal monitor.

(Quality Control Team Manager - Kwak Dong Hun)

52 Product Specifications

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