Bionics BFM-900L Bedienungsanleitung
Operation Manual
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
BFM-900L
FETAL MONITOR (Ver 1.1)
(MAR. 27. 2009)
OPERATION MANUAL
Introduction
General
Warranty Period
Service Request
How to contact us
Chapter 1. How to use the User’s Manual
1.1 General
1.2 Contents
1.3 Meaning of Symbols in the User’s Manual
Chapter 2. Precautions for Us
2.1 Precautions for Using-Environment
2.2 Precautions for Electric Safety
2.3 Maintenance and Cleanness
Chapter 3. Overview of BFM-900L
3.1 Principle and Features of BFM-900L
3.2 Composition
3.3 Parts
3.4 Symbols
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Table of Contents
Chapter 4. How to install BFM-900L
4.1 Precautions for Installation
4.2 Installation of Main Body
4.3 Cable Connection
4.4 Pinter Paper Loading
Chapter 5. How to use BFM-900L
5.1 Before using BFM-900L
5.2 Using BFM-900L
5.3 Basic Screen
5.4 Functions of Keys
5.5 Measurement of FHR and UC
5.6 How to use Event Mark
5.7 How to use the printer
5.8 Volume Control
5.9 Alarm On/Off
5.10 Sound
5.11 AST(Optional)
Chapter 6. Setting by Menu Function
6.1 Record Setting
6.2 Alarm Setting
6.3 Volume Setting
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6.4 Time Setting
6.5 Default Setting
Chapter 7. Solution for Precaution and Warning
Chapter 8. Power
8.1 AC Power
8.2 Battery Power(Optional)
Chapter 9. Simple Troubleshooting
Chapter 10. Specification
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General
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BFM-900L
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.
We, Bionics, provide you with reliable products only.
The device shall be assembled/extended/amended/repaired by us or the person certified by us.
The device shall be installed meeting relevant regulations including electrical installation and etc.
The device shall be used in accordance with the User’s Manual.
The device shall be used under the direction of the person who is medically certified.
This device is used to monitor the fetus’s status.
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.
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Warranty Period
Service Request
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BFM-900L
SERVICE REQUEST
The service for Bionics products can be carried out by only Bionics Customer Service Dept or the
person certified of such service by Bionics. If the device is repaired or tried to be repaired by any
person other than such certified person for the warranty period, the warranty period shall be void.
Bionics Customer Service Dept or any distributor certified of Bionics Product Service is obligated
to carry out any service requested by the user.
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, 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.
WARRANTY PERIOD
This product is made through strict quality management and test process. This product can be
repaired, replaced or refunded in accordance with “Consumer’s Damage Compensation
Regulation” noticed by Economic Planning Board.
This product is warranted for 1 year.
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, please let us know the model name, device number,
purchasing date and breakage content.
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How to Contact Us How to use the User’s Manual
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BFM-900L
CHAPTER 1 How to use the User’s Manual
1.1 General
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
fetus’s status.
This manual covers BFM-900L, a Fetal Monitor manufactured by Bionics, which is
designed for maximal user’s convenience. This manual consists of independent chapters.
Some information is specified several times here in this manual.
This manual is a guidebook for efficient use of BFM-900L. For clinical and pathological
information about the device, please refer to basic relevant medical books. Then, you will use
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:
Chapter 1. How to use the User’s Manual
Chapter 2. Precautions for Use
Chapter 3. Overview of BFM-900L
Chapter 4. How to install BFM-900L
Chapter 5. How to use BFM-900L
Chapter 6. Setting by Menu Function
Chapter 7. Solution for Precaution and Warning
Chapter 8. Use of Power
Chapter 9. Simple Troubleshooting
Chapter 10. Specification
HOW TO CONTACT US
BIONICS Co., Ltd.
Tel : 82-2-714-2962
* Before making reservation on troubleshooting, please check the
model name, serial number, purchasing date and abnormality of the
damaged product.
Customer
Center
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.
Bionics service is always open to you. Please contact us at the number as follows:
Precautions for Use
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How to use the User’s Manual
CHAPTER 2 Precautions for Use
2.1 Precautions of Using-Environment
Avoid using or storing the device under the environments as follow:
Keep it away from wet place or
do not use it by wet hands.
Avoid areas that have high fluctuations
in temperature. (Temperature Range for
Use: 10℃~45℃, Humidity: 30% ~ 85%)
Avoid areas of high humidity or
ventilation problems
Avoid areas susceptible to
large shock or vibration
Keep it away from any electric
heater.
Keep it away from direct
sunlight.
1.3 Meaning of Symbols in the User’ s Manual
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,
neither the manufacturer nor the distributor will be responsible for any damages.
“WARNING” is used to notify the possibility of critical injury, death, and physical and
financial damage in case the warning is ignored
“PRECAUTION” is used to notify the possibility of non-critical injury in case the notice is
ignored
“Note” is used to notify users of not dangerous but very important information regarding
equipment installation, usage, and maintenance
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Precautions for Use Precautions for Use
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BFM-900L
2.2 Precautions for Electric Safety
Before using the device, please check the items as follow:
Is the power supply line of the device proper? (100 - 240VAc).
Is every connection part (power line or any optional device) connected to the device properly?
For correct connection method, see the Chapter 4.
Is the device completely grounded?
(Otherwise, noise may be made.)
To avoid electrical noise or disturbance, install the device away from generators, X-ray devices,
broadcasting devices, and idle wires. Inaccurate reading may show in case above mentioned
devices are nearby. The BFM-900L requires a separate power source and stable connection.
Inaccurate reading may show in case these devices are sharing the same power line.
BFM-900L is classified as follows:
- This device is I type-BF grade device in terms of electric shock.
- It is improper to use this device nearby inflammable anesthetic and solvent.
- IEC/EN 60601-1 (Safety of Electric Medical Equipment) based noise making is A class.
IEC/EN 60601-1-2 (Electromagnetic Compatibility Requirements) based noise proof is B level.
Avoid areas near
chemicals or explosive gas
Do not disassemble it.
We WILL NOT be responsible under
any circumstances in this case.
Hold the plug to withdraw the
power cord.
Do not power it on before
completely installed.
Otherwise, it may be damaged.
Do not submerge the probe for
5 hours or longer.
Make sure to not let any dirt or
especially metallic objects from
going inside the equipment
Basic environments for use are as follow:
Temp : 10℃~ 45℃
Pressure : 70 ~ 106 KPa
Humidity : 30% ~ 85%
Basic environments for storage are as follow:
Temp : -10℃~ 50℃
Pressure : 70 ~ 106KPa
Humidity : 20% ~ 95%
IPX7
(DOP, UC Probes)
If you connect other devices to use RS-232C port, you should use the devices which are satisfied
with standard EN60601-1.
Overview of BFM-900L
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BFM-900L
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Precautions for Use
3.1 Principle and Features of BFM-900L
BFM-900L is a Fetal Monitor, which basically measures the fetus’s heart rate and the patient’s
uterus shrinkage. BFM-900L sends supersonic signal to the patient’s abdomen and then measures
the signal returned from the fetus’s heart. It then sorts out the Doppler frequency from the returned
signal and converts it into the heart beat of the fetus. The signal is then analyzed and displayed as
the fetus’s heartbeat and printed out on a printer. The patient’s contraction level of uterus can be
measured with pressure sensors, as well as printing out the data to inform the level of her labor
pain and frequency. BFM-900L is that the adjustments and values of the signals can easily be
controlled with simple key controls. BFM-900L is capable of measuring twin fetus, and supports
an optional central monitoring system on serial communication. It is also available AST(optional)
function.
3.2 Composition
Basic Accessories
- Supersonic Probe (DOP) (2EA)
- UC Probe (1EA)
- Event Mark Jack(1EA)
- Printer Paper (1EA)
- Power Cord (1EA)
- 110V AC Conversion Jack (1EA)
- User’s Manual (1 Volume)
- Supersonic Gel(1EA)
- Belt for Probe Fixation (3EA)
Options
- Central Monitoring Device Cable/Communication Program
- Cart
- AST Probe
- Internal Battery
2.3 Maintenance and Cleanness
You can maintain cleanliness on BFM-900L and its accessories (including the probe) in various
ways. Use the method provided below to avoid damage or contamination on the equipment.
If you use materials that can damage the product, (non-approved cleaning material) the warranty
will be voided.
Using warm water, clean the main body with alcohol on a soft cloth at least once a month, and do
not use lacquer, thinner, ethylene, and acidic cleansers. These materials can damage the device.
The cable and accessories must be maintained to avoid contact with dirt and wiped down with
warm water (approximately 104℉) on a cloth pad, and use alcohol to clean it once a week.
Do not dowse the connection parts of the accessories in liquid or detergent. Also, no liquid must
go in the connection part of the device or the accessories.
After cleaning the device, check the main body and the sensors very carefully.
If the device is overused and damaged, do not use it.
CHAPTER 3 Overview of BFM-900L
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