Bionet FC1400 User manual

FC1400
Operation Manual
Ver. 2.04
2017.01.20
www.ebionet.com

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FC1400 Operation Manual
Warranty Period
This product is manufactured and passed through strict quality control and through
inspection.
Compensation standard concerning repair, replacement, refund of the product complies
with “Consumer’s protection law” noticed by Economic Planning Dept.
Warranty period is 1 year (Two years in Europe).
We will repair or replace any part of the FC1400 found to be defective in usual operating
circumstance for free to you.
This warranty does not apply to any defect caused by improper abuse, misuse or exposure to
poor management.
Warning
Federal law restricts this device to sale by or on the order of a physician

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FC1400 Operation Manual
Contact Bionet
If you have any questions or comments relating to our products or purchasing,
please contact the telephone numbers or E-mail below. You can talk to our sales
people. Bionet always welcomes your enquiries. Please contact us.
※In the event of a malfunction or failure, contact Service Dept. Of Bionet Co., Ltd.
along with the model name, serial number, date of purchase and explanation of
failure.
Contact Us
Bionet Co.,Ltd.
•Address: 5F, Shinsegae I&C Digital Center 61 Digital-ro 31 gil,
Guro-gu, SEOUL 08375, REPUBLIC OF KOREA
•Tel: [phone]
•Fax: [phone]
•E-mail: [e-mail]
[e-mail]
•URL: http://www.ebionet.com

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Charged service
If you request for any non-warrantyservice, including checking the unit when there is no
problem present, you will be charged accordingly.Therefore, please be sure to read this user
manual.
- Use instructions and simple checking without disassembly
- Reinstallation due to improper installation by a seller
Charged beginning the second time
The service provided the first time
shall be free of charge.
- Improper installation due to any movement of the product or
any movement of the user’s office
- Reinstallation after installation at the time of purchase as
requested by the customer
- Reinstallation due to improper installation by the consumer
- Any and all services requested due to any foreign material
put into the product or improper cleaning or abuse.
Charged the first time
1. Product cleaning, adjustments, use instructions, etc., are not product troubles.
(If the product cannot be repaired, separate criteria shall apply.)
2. In case of trouble due to any fault of the consumer
When a problem has been caused by the consumer’s careless handling or incorrect repair
- When a problem has been caused by the use of incorrect electric capacity
- When problem or damage has been caused by dropping
- When a problem has been caused by the use of consumables or accessories other than those
designated by the company
- When a problem has been caused by repair performed by persons other than an engineer from
Bionet Co., Ltd. or from any agency authorized by Bionet Co., Ltd.
3. Other cases
- When a problem has been caused by a natural disaster (fire, damage by salt, damage by water,
earthquake, etc.)
- When the lifetime of a consumable part (accessory) has ended

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Table of Contents
CHAPTER 1. BASICS................................................................................................ 8
DEFINITION OF WARNING,PROHIBITION,MANDATORY ACTION,AND,NOTE.............................. 8
GENERAL PRECAUTION ON ENVIRONMENT............................................................................. 9
GENERAL PRECAUTION ON ELECTRIC SAFETY ......................................................................13
SAFETY SYMBOLS...............................................................................................................18
CHAPTER 2. INSTALLATION................................................................................. 19
1) OVERVIEW OF THE PRODUCT ...........................................................................................19
2) CHARACTERISTICS OF THE PRODUCT................................................................................19
3) COMPOSITION OF THE PRODUCT ......................................................................................20
4) COMPOSITION OF FC1400...............................................................................................22
5) SYSTEM INSTALLATION ....................................................................................................25
CHAPTER 3. BASIC OPERATION.......................................................................... 28
1) SYSTEM START ...............................................................................................................28
2) SYSTEM FINISHING..........................................................................................................28
3) GRAPHIC SCREEN ...........................................................................................................28
4) OPERATION PANEL..........................................................................................................29
5) MENU.............................................................................................................................30
6) POWER CONNECTION ......................................................................................................32
7) OPERATING MODES........................................................................................................35
CHAPTER 4. PATIENT & DATA MANAGEMENT .................................................. 36
1) PATIENT REGISTRATION...................................................................................................36
2) EDIT PATIENT INFORMATION.............................................................................................37
CHAPTER 5. FHR MEASUREMENT USING US..................................................... 38
1) FHR MEASUREMENT .......................................................................................................38
2) US SCREEN....................................................................................................................40
3) SETUP............................................................................................................................40
CHAPTER 6. EXTERNAL MEASUREMENT OF UTERINE CONTRACTION......... 43
1) UC MEASUREMENT .........................................................................................................43
2) TOCO SCREEN...............................................................................................................45
3) SETUP............................................................................................................................45
CHAPTER 7. FETAL MOVEMENT MEASUREMENT............................................. 47
CHAPTER 8. STIMULATOR.................................................................................... 49

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CHAPTER 9. CLINICAL MARK AND NOTE........................................................... 50
CHAPTER 10. TRACE............................................................................................. 52
1) TRACE AREA...................................................................................................................52
2) TRACE............................................................................................................................53
3) SETTING UP TRACE MODES..............................................................................................54
CHAPTER 11. PRINT .............................................................................................. 56
1) PRINTING IN REAL TIME....................................................................................................56
2) TREND PRINTING.............................................................................................................57
3) PAPER REPLACEMENT.....................................................................................................57
CHAPTER 12. ALARM AND PRESET .................................................................... 58
1) PATIENT CONDITION ALARM .............................................................................................58
2) PRODUCT CONDITION ALARM ...........................................................................................58
3) VISUAL ALARM................................................................................................................59
4) ALARM LED....................................................................................................................59
5) AUDIBLE SILENCE AND PAUSE .........................................................................................59
6) ALARM LATCHING............................................................................................................60
7) ALARM HISTORY..............................................................................................................60
8) PRESET..........................................................................................................................61
9) ALARM VOLUME ADJUSTMENT ..........................................................................................62
10) SETTING ALL ALARMS ON/OFF......................................................................................63
11) SETTING ALL ALARMS RANGES .......................................................................................63
12) SETTING ALL ALARM LEVELS ..........................................................................................64
13) DEFAULT SETTING ........................................................................................................64
CHAPTER 13. NETWORK....................................................................................... 65
CHAPTER 14. GENERAL SETTING ....................................................................... 67
1) DATE CHANGING .............................................................................................................67
2) TIME CHANGING..............................................................................................................67
3) LANGUAGE CHANGING.....................................................................................................67
4) VERSION INFORMATION ...................................................................................................68
5) CHANGING THE TOUCH VOLUME.......................................................................................68
6) DEMO OPERATION...........................................................................................................68
7) EDIT NOTE .....................................................................................................................68
8) MARKER SOUND..............................................................................................................69
9) FACTORY........................................................................................................................69
10) CHANGE ADMIN PW......................................................................................................69
11) VOLUME RANGE............................................................................................................69
12) CHANGING THE SCREEN OUTPUT MODE ..........................................................................69
13) PROTOCOL VERSION.....................................................................................................69

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CHAPTER 15. NST.................................................................................................. 70
1) NST MEASUREMENT .......................................................................................................70
2) NST SETTING.................................................................................................................70
CHAPTER 16. CTG TERMS.................................................................................... 71
1) SETTING.........................................................................................................................71
2) CTG OUTPUT.................................................................................................................71
3) CTG MEASUREMENT RESULTS ........................................................................................72
4) GLOSSARY OF CTG TERMS.............................................................................................73
5) ACCELERATION..........................................................................................................74
6) LATE DECELERATION.................................................................................................75
7) EARLY DECELERATION..............................................................................................76
8) VARIABLE DECELERATION...........................................................................................77
CHAPTER 17. MESSAGE LIST............................................................................... 78
CHAPTER 18. SIMPLE TROUBLESHOOTING....................................................... 79
1) TROUBLESHOOTING AND SOLUTIONS................................................................................79
2) PERFORMING PERIODIC INSPECTIONS...............................................................................79
CHAPTER 19. PRODUCT SPECIFICATION........................................................... 80
APPENDIX A. MANUFACTURER’S DECLARATION - ELECTROMAGNETIC
IMMUNITY................................................................................................................ 82
APPENDIX B. MAINTENANCE, CARE, AND SERVICE......................................... 87
APPENDIX C. ULTRASOUND POWER.................................................................. 89
APPENDIX D. ABBREVIATION AND SYMBOL ..................................................... 92

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Chapter 1. Basics
Definition of Warning, Prohibition, Mandatory Action, and, Note
For special emphasis on agreement, terms are defined as listed below in user’s manual. Users should
operate the equipment according to all the warnings and cautions.
Warning
To inform that it may cause serious injury or death to the patient, property damage,
material losses .
Caution
To inform that it may cause no harm in life but lead to injury.
Mandatory Action
To inform that it must be done for safe operation and maintenance of the equipment.
Note
To inform that it is not dangerous but important “note” sign for proper installation, operation, and
maintenance of the equipment.

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General Precaution on Environment
Do not keep or operate the equipment in the environment listed below.
Avoid placing in an area
exposed to moisture.
Do not touch the equipment
with wet hands.
Avoid exposure to direct
sunlight
Avoid placing in an area
where there is a high
variation of temperature.
Operating temperature
ranges from 10(C to
40(C. Operating humidity
ranges from 30% to 85%.
Avoidplacing in the vicinity of
Electric heaters
Avoid placing in an area
where there is an excessive
humidity rise or ventilation
problem.
Avoid placing in an area
where there is an excessive
shock or vibration.
Avoid placing in an area
where chemicals are
stored or where there is
danger of gas leakage.
Avoid inserting dust and
especially metal
material into the equipment
Do not disjoint or
disassemble the equipment.
We take no responsibility for
it.
Power off when the
equipment is not fully
installed.
Otherwise, equipment could
be damaged.

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CAUTIONS
Before Installation
Compatibility is critical to safe and effective use of this device. Please contact your local sales or
service representative prior to installation to verify equipment compatibility.
Defibrillator Precaution
Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage
resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the
recommended cables and lead wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful
defibrillation.
Disposables
Disposable devices are intended for single use only. They should not be reused as performance could
degrade or contamination could occur.
Disposal of your old appliance
1. When this crossed out wheeled bin symbol is attached to a product it means
the product is covered by the European Directive 2002/96/EC.
2. All electrical and electronic products should be disposed of separately from the
municipal waste stream via designated collection facilities appointed by the
government or the local authorities.
3. The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
4. For more detailed information about disposal of your old appliance, please
contact your city office, waste disposal service or the shop where you
purchased the product.
WARNING
This product contains a chemical known to the State of California to cause cancer,
birth defects, or other reproductive harm.
Electrocute Precautions
To prevent skin burns, apply electrocute electrodes as far as possible from all other electrodes, a
distance of at 15 cm/6 in. is recommended.
EMC
Magnetic and electrical fields are capable of interfering with the proper performance of the device. For
this reason make sure that all external devices operated in the vicinity of the monitor comply with the
relevant EMC requirements. X-ray equipment or MRI devices are possible source of interference as
they may emit higher levels of electromagnetic radiation.
Also, keep cellular phones to other telecommunication equipment away from the monitor.

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CAUTIONS
Instruction for Use
For continued safe use of this equipment, it is necessary that the instructions are followed. However,
instructions listed in this manual in no way supersede established medical practices concerning
patient care.
Loss of Data
Should the monitor at any time temporarily lose patient data, the potential exists that active monitoring
is not being done. Close patient observation or alternate monitoring devices should be used until
monitor function is restored.
If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor
using the power on/off switch. Once monitoring is restored, you should verify correct monitoring state
and alarm function.
Maintenance
Regular preventive maintenance should be carried out annually (Technical inspections). You are
responsible for any requirements specific to your country.
MPSO
The use of a multiple portable socket outlet (MPSO) for a system will result in an enclosure leakage
current equal to the sum of all individual earth leakage currents of the system if there is an interruption
of the MPSO protective ground conductor. Do not use an additional extension cable with the MPSO as
it will increase the chance of the single protective ground conductor interruption.
Negligence
BIONET does not assume responsibility for damage to the equipment caused by improperly vented
cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on such
walls.

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NOTES
Power Requirements
Before connecting the device to the power line, check the voltage and frequency. Ratings of the power
line are the same as those indicated on the unit’s label. If this is not the case, do not connect the
system to the power line until you adjust the unit to match the power source.
In U.S.A, if the installation of this equipment will use 240V rather than 120V, the source must
be a center-tapped, 240V, single-phase circuit.
Restricted Sale
U.S.A federal law restricts this device to sale by or on the order of a physician.
Supervised Use
This equipment is intended for use under the direct supervision of a licensed health care practitioner.
Ventilation Requirements
Set up the device in a location which affords sufficient ventilation. The ventilation openings of the
device must not be obstructed. The ambient conditions specified in the technical specifications must
be ensured at all times.
·Put the monitor in a location where you can easily see the screen and access the operating controls.
-This product is protected against the effects of cardiac defibrillator discharges to ensure proper
recovery, as required by test standards (The screen may blank during a defibrillator discharge but
recovers within a second as required by the test standards).

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General Precaution on Electric Safety
Check the items listed below before operating the equipment.
- Be sure that power supply line is appropriate to use. (100~240V AC)
- Be sure that the entire connection cable of the system is properly and firmly fixed.
- Be sure that the equipment is completely grounded. (If not, this might cause problems to occur in the
product.)
- Is there any damage - which may affect the monitoring or safety of the patient ― to any of the
equipment or accessories?
NOTE
1. The equipment should not be placed in the vicinity of electric generator, X-ray, broadcasting
apparatus to eliminate electric noise during operation. Otherwise, it may cause incorrect results.
Isolated power line is important for FC1400 To use same power source with other electric
instruments may cause incorrect results.
NOTE
FC1400 is classified as listed below ;
- Do not use the equipment in the vicinity of flammable anesthetics and solvents.
- The monitor is designed to fulfill safety requirements according to IEC 601-1/EN 60601-1
(Class I), Degree of protection against electrical shock type-BF.
NOTE
In hospitals, doctors and patients are exposed to the danger of uncontrollable electric currents.
These electric currents are generated by potential differences between the equipment and
conductive objects that may come into contact with the equipment. Please make sure that the
auxiliary equipment connected to the equipment to solve this problem satisfies EN60601-1-
1:1996.
Warning
Avoid contact with the patient during any defibrillation (may result in serious injury or
death). To avoid the danger of serious electric burning, shock, or injury, everybody
should stay away from the bed and should refrain from touching any equipment
connected to the patient.

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NOTE
This equipment must only be connected to a supply mains with protective ground.
NOTE
Avoid contact with the connector pin of the equipment and the patient at the same time while
the equipment is in use.
Do not connect or remove the power cable with wet hands.
NOTE
In case the medical equipment does not operate normally, or if it has been damaged, do not use
it on any patient; instead, contact the medical equipment engineer in your hospital or the
equipment supplier.
Warning
Devices for fetal heartbeat sound measurements using ultrasonic (US) waves or
uterine contraction measurements (TOCO) performed from outside of the uterus are
not designed for use during any electric operation, defibrillation, or defibrillator
discharge.
Warning
The equipment has not been designed for use with other types of monitoring
equipment apart from those devices permitted for use together with the equipment in
this manual.
Warning
Do not touch signal input, signal output or other connectors, and the patient
simultaneously.
Warning
ELECTROSURGERY - The monitor is not designed for use with high- frequency
surgical devices. In addition, measurements may be affected in the presence of strong
electromagnetic sources such as electrosurgery equipment.
Biocompatibility
When used as intended, the parts of the product described in this operator manual, including
accessories that come in contact with the patient during the intended use, fulfill the biocompatibility
requirements of the applicable standards. If you have questions about this matter, please contact
BIONET or its representatives.

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Maintenance and Washing Equipment
Connection
Although FC1400 and its accessories can be cleaned in many ways, please use the methods
recommended below to avoid unnecessary damage to or contamination of the equipment.
If any dangerous material other than those designated for cleaning has been used, the resulting
contaminated or damaged equipment will not be repaired free of charge even during the warranty
period.
Make sure that the monitor, probe, cable, and accessories are free of sand or dust. Carefully check
the equipment after each cleaning or disinfection. If degeneration or damage has been found, do not
use the equipment.
Please take note of the following:
- Be sure not to leave any cleaning/disinfecting chemical residue on the surface of the equipment.
After allowing sufficient time for the chemical to work, wipe off all residues with a cloth damp with
water.
- Prevent any fluid from seeping into the monitor, module, or accessories.
- The monitor, module, or accessories should not be soaked in any fluid; protect them from water
drops or prevent water from being splashed on them.
- Never use any abrasive material (steel wool or silver polish).
- Never use any bleaching agent.
- Do not use any kind of drying equipment such as heater, oven (including microwave oven), hair
dryer, or heating lamp.
NOTE
After cleaning the equipment, carefully check the main body and the probe.
Component cleaning Electric cable and lead wire
NOTE
- Do not use acetone or ketone solvents for cleaning
- Do not use an autoclave or steam cleaner.
- Do not mix the cleaner with any disinfecting solution (toxic gases may be produced).
- Please turn off the power before cleaning; do not pour water into the item being cleaned

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Electric cables and lead wires can be wiped off or cleaned with towels wet with lukewarm water,
neutral soap, or isopropyl alcohol. Using ethylene oxide for intensive disinfection (almost complete
sterilization) is allowed. Note, however, that it will reduce the lifetime of cables or lead wires. Clean the
belt using soap and water while making sure that the water temperature does not exceed 60°C.
NOTE
The decision to sterilize must be made per your institution’s requirements with an awareness of
the effect on the integrity of the cable or leadwires.
NOTE
The Equipment needs safety inspection once a year. Please refer to user’s guide or service
manual.
After cleaning the equipment, carefully inspect the main body and the sensors. Do not use the
equipment if it has been damaged or if it has deteriorated.
Clean the exterior of the equipment at least once a month using soft cloth wet with tepid water or
alcohol. Do not use lacquer, thinner, ethylene, or any oxidizing agent that may cause damage to the
equipment. After verifying that there is no dust or contamination on the cables and accessories, wipe
them off with soft cloth wet with 40˚C/104˚F water. Wipe them at least once a week using clinical
alcohol.
NOTE
There is back-up battery on board inside system. Please dispose of according to all local
regulations.
Warning
Remove AC power before changing battery.
Check the electrodes of batteries before changing them.
If the installation or arrangement of the external grounding wire is doubtful, operate the equipment with
internal power.
In case the equipment is not to be used for some time, remove the primary battery if no safety problem
is expected to occur.

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Safety Symbols Marked on the Package
Symbols
Contents
Show the direction of top
Keep dry
fragile
Not to use hook
NOTE
Annual Servicing –For continued safety and performance of the monitor, it is recommended that
the calibration, accuracy, and electrical safety of the monitor be verified on an annual basis by a
Bionet Service Representative.
Daily Testing –It is essential that the monitor and accessories be inspected every day. It is
recommended practice to initiate the monitor’s self-test feature at the beginning of each monitoring
session; follow the instructions in Chapter 1,2.

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Safety Symbols
The International Electro technical Commission (IEC) has established a set of symbols for medical
electronic equipment which classify a connection or warn of any potential hazards. The classifications
and symbols are shown below.
Symbols
contents
Defibrillation proof type CF applied part (IEC 601-1)
External Signal IN/OUT Port
IEC 60601-1 Type BF applied part
Stand by
External Signal Ethernet Port
External Signal USB Port
IEC 60601-1 Type CF applied part
Equipotentiality
Video Out
IPX0, IPX1 and IPX7
Protection against vertically falling water drops(IEC 60529) Water
Protection Specification Level 0, Level 1 and Level 7
Follow operating instructions (IEC 60878 Safety)
Consult accompanying documents
This symbol indicates that waste electrical and electronic equipment
must not be disposed of as unsorted municipal waste and must be
collected separately.

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Chapter 2. Installation
1) Overview of the product
FC1400 is a fetus monitoring device used to measure Fetal Heart Rates (FHR), degree of maternal
uterine contraction (UA: Uterine Activity),and fetal movements (FM). FC1400 projects ultrasounds into
the abdomen of the patient. From the signals returned after being reflected by the heart of the fetus,
FC1400 extracts Doppler frequencies that vary with the movements of the heart of the fetus to output
changes in the heartbeats of the fetus as sounds for the analysis of the signals; thus detecting the
heart rates and fetal movements of the fetus. In addition, it detects the degrees of uterine contraction
of patient using a pressure sensor. It indicates the fetal heart rates, maternal uterine activity, and fetal
movements on its LCD screen as figures and saves the information to its memory.
2) Characteristics of the product
1. The product measures fetal heart rates and fetal movements simultaneously.
2. By using the US probe for twin fetus, twin fetus’ FHR and fetal movements can be measured.
(optional specification)
3. Measured data can be saved and identified on the LCD. Thus, the condition of the fetus can be
efficiently monitored during labor without wasting recording sheets.
4. While reviewing the saved data, any data that should be kept in recording sheets can be printed at
high speeds.
5. With ultrasound Doppler probes having high durability even against noise, clear sounds of the
heartbeats of the fetus and accurate FHR of the fetus can be detected.
6. Its ultrasound irradiation radius was remarkably increased using 7-crystal, 1MHz to minimize
broken FHR waveforms even if the fetus or the patient moves.
7. Since new design concepts have been applied, Tilt is mechanically possible. Thus, the product
can be used conveniently anywhere.
8. Universal communication interfaces including LAN are provided for connection with the central
parturition monitoring system.
9. Rechargeable batteries are used; thus, parturition conditions can be continuously monitored even
during a power failure. (optional specification)
Warning
Using accessories other than those supplied by the company or non-standard ones
may cause signal distortions or noise. Be sure to use only standard accessories
supplied by the company.

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3) Composition of the product
The Fetal system has the following components (please open the package box and check if the
following components are included; in addition, please check the main body and the components for
any damage):
▣Basic composition and accessories
①Fetal system main body
②US probes (2)
③TOCO probe (1)
④Marker for patient (1)
⑤Recording sheet (2)
⑥Power cord (1)
⑦Adaptor (1)
⑧Ultrasonic gel (1)
⑨Fixing belt (3)
⑩FC1400 Stand (1)
▣Optional specification
⑪Battery (1)
<Option>