FC1400

Operation Manual

Ver. 2.03
2016.08.23

www.ebionet.com
 FC1400 User 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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How to reach us …

The following are telephone numbers and addresses for contacting various service, product
supplies and sales personnel

Product and Bionet Co.,Ltd.

Purchase Address #1101 11F E&C Venture Dream Tower3 38-21, Digital-

Inquiry Ro, 31-Gil, Guro-Gu, Seoul (ZIP 08376), REPUBLIC OF KOREA

Overseas sales dept.
Tel :++82-2-6300-6410
Fax : ++82-2-6499-7789
E-mail : [email protected]
URL : http:// www.ebionet.com

※ 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.

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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.

Charged beginning the second

- Use instructions and simple checking without
time
disassembly
The service provided the first time
- Reinstallation due to improper installation by a seller
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 Charged the first time
consumer
- Any and all services requested due to any foreign
material put into the product or improper cleaning or
abuse.

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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 FC1400 User Manual

Table of Contents
CHAPTER 1. BASICS ................................................................................... 8
DEFINITION OF W ARNING, 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 ............................................................................................... 58
3) PAPER REPLACEMENT ....................................................................................... 58

CHAPTER 12. ALARM AND PRESET ........................................................ 59

1) PATIENT CONDITION ALARM ............................................................................... 59
2) PRODUCT CONDITION ALARM ............................................................................. 59
3) VISUAL ALARM .................................................................................................. 60
4) ALARM LED...................................................................................................... 60
5) AUDIBLE SILENCE AND PAUSE ........................................................................... 60
6) ALARM LATCHING.............................................................................................. 61
7) ALARM HISTORY ................................................................................................ 61
8) PRESET ............................................................................................................ 62
9) ALARM VOLUME ADJUSTMENT ............................................................................ 63
10) SETTING ALL ALARMS ON/OFF ........................................................................ 64
11) SETTING ALL ALARMS RANGES ......................................................................... 65
12) SETTING ALL ALARM LEVELS ............................................................................ 65
13) DEFAULT SETTING .......................................................................................... 66

CHAPTER 13. NETWORK .......................................................................... 67

CHAPTER 14. GENERAL SETTING ........................................................... 69

1) DATE CHANGING ............................................................................................... 69
2) TIME CHANGING ................................................................................................ 69
3) LANGUAGE CHANGING ....................................................................................... 69
4) VERSION INFORMATION ..................................................................................... 70
5) CHANGING THE TOUCH VOLUME ......................................................................... 70
6) DEMO OPERATION ............................................................................................. 70
7) EDIT NOTE ....................................................................................................... 70
8) MARKER SOUND................................................................................................ 70
9) FACTORY ......................................................................................................... 71
10) CHANGE ADMIN PW ........................................................................................ 71
11) VOLUME RANGE .............................................................................................. 71
12) CHANGING THE SCREEN OUTPUT MODE ............................................................ 71
13) PROTOCOL VERSION ....................................................................................... 71

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CHAPTER 15. NST ...................................................................................... 72

1) NST MEASUREMENT ......................................................................................... 72
2) NST SETTING ................................................................................................... 72

CHAPTER 16. CTG TERMS ........................................................................ 73

1) SETTING ........................................................................................................... 73
2) CTG OUTPUT ................................................................................................... 73
3) CTG MEASUREMENT RESULTS .......................................................................... 74
4) GLOSSARY OF CTG TERMS ............................................................................... 75
5) ACCELERATION ............................................................................................ 76
6) LATE DECELERATION................................................................................... 77
7) EARLY DECELERATION ................................................................................ 78
8) VARIABLE DECELERATION ............................................................................. 79

CHAPTER 17. MESSAGE LIST .................................................................. 80

CHAPTER 18. SIMPLE TROUBLESHOOTING .......................................... 81

1) TROUBLESHOOTING AND SOLUTIONS .................................................................. 81
2) PERFORMING PERIODIC INSPECTIONS................................................................. 81

CHAPTER 19. PRODUCT SPECIFICATION............................................... 82

APPENDIX A. MANUFACTURER’S DECLARATION -

ELECTROMAGNETIC IMMUNITY .............................................................. 84

APPENDIX B. MAINTENANCE, CARE, AND SERVICE ............................ 89

APPENDIX C. ULTRASOUND POWER ...................................................... 91

APPENDIX D. ABBREVIATION AND SYMBOL ......................................... 94

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 FC1400 User Manual

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.
Avoid exposure to direct
Do not touch the
sunlight
equipment with wet
hands.

Avoid placing in an area

where there is a high
variation of temperature. Avoidplacing in the
Operating temperature vicinity of Electric
ranges from 10(C to heaters
40(C. Operating
humidity ranges from
30% to 85%.

Avoid placing in an area

where there is an Avoid placing in an area
excessive where there is an
humidity rise or excessive shock or
ventilation vibration.
problem.

Avoid placing in an area Avoid inserting dust and

where chemicals are especially metal
stored or where there is material into the
danger of gas leakage. equipment

Do not disjoint or Power off when the

disassemble the equipment is not fully
equipment. installed.
We take no Otherwise, equipment
responsibility for it. 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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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.

Safety Symbols Marked on the Package

Symbols Contents

Show the direction of top

Keep dry

fragile

Not to use hook

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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 Protection against vertically falling water drops(IEC 60529) Water
IPX7 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):

<Option>

▣ Basic composition and accessories ▣ Optional specification

① Fetal system main body ⑫ Battery (1)
② US probes (2)
③ TOCO probe (1)
④ Marker for patient (1)
⑤ Recording sheet (2)
⑥ Power cord (1)
⑦ Adaptor (1)
⑧Ultrasonic gel (1)
⑨ Fixing belt (3)
⑩ User manual (1)
⑪ FC1400 Stand (1)

Warning

Do not reuse the ultrasonic gel.

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Warning

How to replace battery: Please make sure you use the right battery as shown
here.
Otherwise we are not liable for any damages and/or explosion caused by the
wrong battery.

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4) Composition of FC1400
▣ Top view
②

① ③

① Graphic display window: Part that displays the contents of measurements and condition
of the equipment
② Alarm LED : Part that displays the status of alarm
③ Control panel : Controls the functions
④ Printer door : Opens for replacing recording paper

Warning
To avoid high-voltage electric shock, please refrain from disassembling the
equipment. If any of the probes has been damaged, please stop using it to
prevent electric shock and contact our company’s service center or agency
for the replacement of the probe. Disassembly, etc., may be performed only
by those who are qualified to provide service for our products.

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▣ Front view

① Hand Grip : Use when lifting and moving the equipment

▣ Rear view

② ③ ④

① Power adaptor connector: Power adaptor of 18V, 2.8 A is connected

② LAN Port: Part for LAN communications with external equipment
③ USB1 Port: Part for USB1 communications with external equipment
④ USB2 Port: Part for USB2 communications with external equipment

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▣ Right side view

Printer door release lever: Slide lever to open printer door

▣ Left side view

③ ④ ⑤

① Marker jack connection terminal: Terminal to which the marker jack cable is to be
connected
② Stimulator jack connection terminal : Terminal to which the stimulator cable is to be
connected.
③ US probe connection terminal 1: Connection terminal to which the US probe is to be
connected
④ US probe connection terminal 2: Connection terminal to which the US probe is to be
connected when measuring twin fetus
⑤ TOCO probe connection terminal: Connection terminal to which the TOCO probe is to be
connected

Prohibition
Please instruct the operators to avoid contact with both the USB or LAN port
area and the patient simultaneously.
RISK OF ELECTRICAL SHOCKS – DO NOT OPEN THE DEVICE : Device
disassembly is only authorized to individuals with Bionet service
authorization.

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5) System installation

▣ Cautions in installation
Preparations before use

- Be sure to use this equipment in dry condition at normal temperatures (temperature: 10

∼ 40℃, humidity: 30 ∼ 85％).
- Be sure to use an outlet away from any equipment that may generate electric noise
(room heating/cooling equipment using a large motor, etc.).
- Installation of recording paper: You can open printer cover by pushing “Printer cover
open” lever to the right. Load paper with printable side up and close the cover
- Put the adaptor into the connection site at the back of the main body to connect power
to the equipment. At this time, please check if the Power Cord has been installed
properly.

Storage Temperature : -10~+60°C

Storage Pressure : 70(700)~106Kpa(1060mbar)
Storage Humidity : 20~95%(without condition)

FC1400 stand installation (Option)

- Insert the FC1400 stand to the stand hole on the underside of the FC1400

Stand hole

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Operating procedure
- Turn on power to the equipment. Power will be turned on if the power switch on the
front side of the main body is pressed for two seconds when power has been turned off;
on the other hand, power will be turned off if the power switch is pressed for two
seconds when power has been turned on.
- Put some ultrasound gel on US probe, find heart beat of fetus and fix it around the
abdomen of pregnant woman using a fixing belt.
- Fix TOCO probe on Fundus which is located 10 cm above the belly button of the
maternal abdomen using a fixing belt.
- Determine a use mode and use the equipment accordingly.

How to store and manage the equipment after use

- Turn off the power switch and unplug the power cord.
- When the operation has been completed, clean the equipment and accessories to
prevent malfunction.

Cautions in use
Installation and storage
- Please avoid moisture, high temperature, dust in the air, salt, and sulfuric materials
including places that are not well-ventilated and direct sunlight.
- Please avoid vibrations or mechanical impacts.
- Please avoid places where chemicals are stored or gases are generated.
- The equipment should operate at the indicated voltage and frequency.

Before operation
- The equipment should be properly grounded.
- Please connect all cords accurately and safely.
- When using an optional battery, please charge it for at least four hours.
- Any area directly connected to the patient should be double-checked.
- Please use the equipment within the range of operating temperatures.

During operation
- The patient should not come into contact with any metal areas of the equipment such as
sash or case. The operator should not touch the patient and the equipment
simultaneously.
- If any abnormality has been found, turn off power and unplug the power cord.
- Do not use any sharp or pointed object when pressing the LCD or any touch key.
- Do not confuse demo data with patient data.

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After use
- Turn off the power switch and unplug the power cord.
- Take off the probes connected to the patient.
- Once the operation has been completed, clean the equipment and accessories to
prevent malfunction.

Periodic checking
- Please keep the main body and the measuring probe clean by wiping them off with soft
cloth wet with alcohol at least once a month. Do not use lacquer, thinner, ethylene, or
oxidizing substances.
- Keep the cables free of dust or dirt. Wipe off the cables with cloth wet with tepid water
(40˚C/104˚F) after use and wipe them off with clinical alcohol at least once a week.
- Please periodically check this equipment once a year.
- The equipment should be serviced only by designated specialized engineers.

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Chapter 3. Basic operation

1) System start
Press the power switch on the main body for two seconds; power will then be turned on, with
the company name displayed for around five seconds followed by the home screen.

2) System finishing
Holding the power switch for 3 seconds will turn off. Holding the power button of the device
for more than 6 seconds will trigger power off action.

3) Graphic screen
▣ Monitoring screen

① Date and time

② Patient name or ID
③ Bed ID
④ Icon indicating the state of connection of the USB terminal
⑤ Icon indicating the state of printing
⑥ Icon indicating the state of connection of the network
⑦ Icon indicating the state of alarm sound and volume of Alarms
⑧ Icon indicating the residual battery capacity
⑨ Parameter window of fetal hart rates
⑩ Parameter window of Uterine contraction
⑪ Main menu
⑫ Window displaying the trends of fetal heart rates
⑬ Window displaying the trends in the degrees of uterine contraction, fetal movements

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4) Operation panel ① ②

③ ④

⑤ ⑥

⑦ ⑧

⑨ ⑩
⑩
⑪ ⑫

① AC power input LED: LED indicating the state of AC power connections

② Battery operation LED: LED indicating the state of battery charges
③ US1 volume up button
Short key : US1 Volume up or moving to earlier 1 min in trace mode
Long key : Return US1 volume back to the Pre-Mute stage.
④ US2 volume up button
Short key : US2 Volume up or moving to later 1 min in trace mode
Long key : Return US2 volume back to the Pre-Mute stage.
⑤ US1 volume down button
Short key : US1 Volume down or moving to earlier 6 Secs in trace mode
Long key : Mute US1 sound
⑥ US2 volume down button
Short key : US2 Volume down or moving to later 6 Secs in trace mode
Long key : Mute US2 sound
⑦ Clinical Mark and Note button:
Short key : Clinical Mark . To be used by user to record clinical mark.
Long key : To be used by user to record clinical note
⑧ Adjustment of zero point of the degree of uterine contraction
Attach the TOCO probe on the abdomen of the patient and press the zero point adjusting
button to set the reference value.
⑨ Trace button: This is used to view trace data.
⑩ Alarm silence key : This is used to change alarm status : silence, pause, alarm off, alarm
on

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⑪ Home and function key: General screens and large value screens can be swapped; the
function of a home key to move from a sub-menu to the main screen can be executed.
⑫ Printing start/stop key and Paper feeding key

Short key :
A. This is used to record data on the recording sheet in real time in the monitoring
mode.
B. This is also used to print data on the recording sheet at high speeds in the data
view mode.
Long key : Paper feeding key Used when feeding paper while printing is stopped.

5) Menu
▣ Menu selection

To go to a menu, touch the main menu or parameter window on the screen.

▣ Letter entry
To enter a letter, drag the cursor to the letter using the wheel and then touch the selection
key or the screen

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▣ Value entry
To enter a value, drag the cursor to the value using the wheel and then touch the selection
key or the screen.

▣ Color selection and entry

To select the color of a line or a numerical value, drag the cursor to the desired color and
touch the selection key or color on the screen.

▣ Line selection
To select the thickness of a line of a trend graph or a waveform to be printed, drag the cursor
to the desired line thickness and touch the selection key or the line thickness on the screen.

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6) Power connection
▣ AC power
If AC power is connected to the main body of the equipment, the Power LED on the front
side of the equipment will emit a green light; if a battery has been installed, the power mode
will be automatically changed to automatic charging mode, and the battery will be charged.

▣ Battery power
If the AC power is disconnected, and the equipment is used, power will be supplied by the
battery when the power switch has been turned on; if AC power is connected to the main
body of the equipment, the Power LED on the front side of the equipment will emit a green
light. In case a battery has been installed, the power mode will be automatically changed to
automatic charging mode, and the battery will be charged.

If the battery power is insufficient (8.6V or lower), alarms will sound, and “Battery low” will be
displayed on the LCD screen for a few minutes before power to the equipment is
automatically turned off. In this case, AC power should be immediately connected to the
equipment to use it.
- Charging time: Minimum of 4 hours ( Standby status)
- Continuous use time: Maximum 2 hours

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▣ Changes in the screen in relation to the state of battery connection

The battery condition should be displayed in relation to connection of Battery and AC power
and Battery condition as follow

* No Battery

: connect power to the equipment to use it

* Battery with little or no power

: 2 images are toggled

* Battery only

( Low), ( Medium), ( Full )

* AC and Battery

( Low), ( Medium ) ( Full)

▣ Battery replacement
When the battery of this equipment is to be replaced, the same type of battery should be
used.
- Type : SDI1865L240 3S2PMXZ,Lithium Ion Rechargeable Battery Pack
(11.1V/4800mV)
- Time: The battery will be automatically charged when the equipment is connected to AC
power, and the battery cannot be charged when it is separated from the equipment. The
battery can be charged at least 500 times; if using the battery for 20 minutes or longer
after it is completely charged is difficult, please replace the battery with a new one. If the
battery has been damaged, or battery fluid has leaked out, please replace the battery
immediately. Do not use a damaged battery in the equipment.
- Method: Connect the connector as shown in the following image. (Connector cannot be
plugged inversely)

< Connect the Battery>

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Warning
When replacing the battery, please pay attention to the polarity.
Plug/Unplug the Battery with the AC power removed

Warning
To protect the environment, do not carelessly dispose of wastes or residues
such as the components of the equipment after its lifetime; instead, ask the
biomedical engineering department of the hospital to dispose of them in the
designated places following appropriate procedures.
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.

▣ Effect of lithium ion battery technology applied to the battery

Refer to the following descriptions on the lithium ion battery technology:
Batteries will be discharged if they are not connected to a monitor. This discharge is caused
by the currents required by the circuit integrated with the lithium ion batteries. Owing to the
nature of lithium batteries themselves, the batteries are self-discharged. The rate of self-
discharge is doubled every time the temperature is increased by 10℃ (18℉).
The loss of electric capacity retained by a battery is higher when the temperature of the
battery is higher. Over the lifetime of a battery, the capacity of a completely charged battery
will gradually decrease, or the battery may not be charged at all. As a result, the total
capacity that can be stored and used will gradually decrease.

Inspection guideline
Check the performance of the battery every 6 months through complete charge and
complete discharge in the monitoring equipment.

Storage guidelines
The battery should be stored at 20°C ~ 25°C (68°F ~ 77°F) when it is not in the monitor.
When the battery is installed in the equipment and connected to AC power, the temperature
of the battery is increased by around 15°C ~ 20°C (59°F ~ 68°F). This shortens the lifetime
of the battery.
When installed in the equipment and connected to AC power, the battery does not supply
power in general. The lifetime of the battery may be shorter than 12 months. Bionet
recommends detaching the battery from the monitor for storage until the equipment is moved.

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7) Operating modes
There are 3 operating modes. Some are password protected.

Monitoring mode: This is normal mode for monitoring patients. You can change elements
such as alarm limits and so forth. When you discharge the patient, these elements return to
their default values(preset value). Changes can be stored permanently in Configuration
Mode .
Configuration mode : Password protected, this is for personnel trained in configuration
tasks.
Factory mode(Service mode) : Password protected, this is for trained service personnel.

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Chapter 4. Patient & data management

Basic information necessary to identify patients is saved.

1) Patient registration
This is a method of registering patients when the equipment is used as independent
equipment.
If the equipment is used without registering patients, patient IDs will be saved as Default
values.
Patients can be registered using the “New” function if they are measured for the first time. If
the records of the patients measured before are left in the Trace, the “Search” function can
be used to register the patients.

< Registering a new patient >

① Touch “Patient” in the menu.

② Select “New” to register a new patient.

③ Enter the ID, last name, and first name of the patient and press OK.

< Default : ID, last name and first name is made by date and time >

④ Information on the currently registered patient will appear on the position of patient
information on top of the screen.

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< Registering a patient using “Search” >

① Touch “Patient” in the menu.

② Select “Search” to register a patient with records left in the Trace records.

③ By referring to the IDs, last names, and first names shown in the Patient List, touch the
patient to be registered to select said patient.

④ Information on the currently registered patient will appear on the position of patient
information on top of the screen.

2) Edit patient information

This is a method of editing patients information.

① Touch “Patient” in the menu.

② Select “Edit” to edit a patient except ID information

③ Information on the currently registered patient will appear on the position of patient
information on top of the screen.

NOTE

The patient information which has been entered or modified in the device do not
synchronize patient information in the FC central.

NOTE

Patient list will save up to 99 people entered in the recent years.

If it goes beyond 99 patients, first patient in the list is removed.

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Chapter 5. FHR measurement using US

FHRs are measured by obtaining the heartbeat sounds of the fetus using ultrasonic Doppler
effects and subsequently calculating and saving the heart rate per minute in real time. Since
ultrasounds are reduced considerably in the air, please apply sufficient amounts of
ultrasonic gel to the surface of US probes to remove any air layer before using US probes.

This equipment adjusts the volume automatically according to the amount of input data.
When no input occurs while probe is connected, the noise will increase. In the running
condition of the equipment, turn on the Mute by long pressing volume down key when not
measured, long press volume up key to return back to the previous setting for the
measurement.

1) FHR measurement

▣ US probe connection

Please connect US probes to the “US1” and “US2” connection terminals on the left side of
the equipment to use the US probes.

▣ US probe

<New Probe>

▣ Basic operations following a US probe connection

When US Probe is not connected to main body, nothing will display of FHR area. On the
other hand, connection of US Probe will change displaye to “---“ of FHR area. When a US
probe has been put into the “US1” connection terminal, a numerical value will be displayed
in the FHR display area, indicating that the system is ready to measure FHRs.

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▣ How to measure FHRs

① Place a fixing belt below the waist of the patient.

② To remove air bubbles between the abdomen of the patient and the surface of the US
probe, please apply a sufficient amount of ultrasonic gel to the US probe.

③ Feel the abdomen of the patient to find the back side of the fetus and place the US
probe there. If the fetus faces laterally, please place the US probe on the position shown
in the figure below.

NOTE
2. If the US Probe is placed on the side of the chest of the fetus instead of the back
side, ultrasounds will not be accurately shot to the heart of the fetus; thus, the
heartbeat sounds of the fetus may be frequently missed.

④ Move the US probe little by little around its position to place the US probe in a position
where the sounds from the heart of the fetus are heard relatively loud and clear and the
heart shape in the FHR display area turns green and blinks according to the sounds
from the heart of the fetus; adjust the speaker volume so that the sounds from the heart
of the fetus becomes appropriately louder.

⑤ Put the button on the upper part of the US probe into the hole in the fixing belt to fix the
US probe so that the US probe does not slip.
NOTE
If the probe cable is fixed near the head of the patient, the cable will not be damaged,
and there will be relatively less movement by the probe.

It will take around 2~8 seconds for FHRs to be calculated and displayed.

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2) US screen
If the US area on the screen is selected and touched, the following selection window pops up
on the screen:

① Title
② FHR Volume Icon: This informs the user of the current state of the Volume; if this icon is
touched, a volume adjusting window will be displayed.
③ Alarm range: This indicates the alarm ranges of parameters.
④ Beat indication: When FHRs are detected as beats, the heart icon will blink.
⑤ FHR value: This indicates the FHR values.

3) Setup
If the US area on the screen is selected and touched, the following selection window pops up
on the screen (by touching the US1 area, US1-related items and common items can be set
up; by touching the US2 area, US2-related items can be set up):

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▣ FHR Sound Volume adjustment

Touch the Sound Volume menu. Select the value to be set from Off or volumes at levels 1~9.

FHR sounds can be adjusted using the operation panel or LCD screen touch the volume
adjusting icon and select a volume from the popup window. And to adjust the volume of US2,
touch the volume adjusting icon.

In addition, you can directly go to the Sound Volume window using the speaker icon in the
US area.

: Volume Off : Volume

US 1 volume adjusting US 2 volume adjusting

Short: 1 level up Short: 1 level up
Long: Pre-Mute stage Long: Pre-Mute stage

US 1 volume adjusting US 2 volume adjusting

Short: 1 level down Short: 1 level down
Long: US1 Mute Long: US2 Mute

Volume adjusting key of operation panel

▣ Alarm
FHR alarms for US1 and US2 can be adjusted separately.
Please set up whether alarm functions for FHRs will be used.

▣ Alarm level

Set up the levels of alarms for FHRs. Patient condition alarms can be set to Medium and
Low alarms. Please refer to the alarm section in Chapter 6 for details.

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▣ Alarm limit
Touch Alarm Limit section within FHR setting menu to set the alarm range of FHR.
Set by either entering numbers or touching arrow keys.

▣ Alarm delay
This is set up to prevent alarms from ringing when FHR values exceed the alarm range but
only for a short time; the value is not maintained for a certain time.
To set up an alarm delay, please touch the Alarm Delay area in the FHR setting menu. If this
function is not to be used, please select Off; to use this function, please select the minimum
use time.

▣ Color
This is used to set up the colors of FHR values and Trace lines.

▣ Offset
This is used to display FHR2 values on the position where FHR2 Trace values and related
Offset values in printing are found to identify the twin fetus’ FHR values easily when they are
similar to each other.

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Chapter 6. External measurement of

uterine contraction
UAs are measured using external attachment-type pressure sensors. A TOCO probe is
attached to the abdomen of the patient to measure the relative pressures that vary with the
uterine contraction of the patient, thereby recording the uterine activity.

1) UC measurement

▣ TOCO probe connection

Please connect a TOCO probe to the “TOCO” connection terminal on the left side of the
equipment.

▣ TOCO Probe

<New Probe>

▣ Basic operations following a TOCO probe connection

When no TOCO probe has been connected to the main body, “---” will be displayed in the
FHR display area. When a TOCO probe has been connected to the equipment, a numerical
value will be displayed, indicating that the system is ready to measure uterine activities.
When FMs (Fetal Movements) are viewed, “UC+FM” will be displayed.

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▣ UA measurement
① Place a fixing belt below the back of the patient.
② Place a TOCO probe on the highest peak of the abdomen of the patient (Fundus:
located around 10cm above the umbilicus) or the place that hardens first in the abdomen
of the patient.
③ Put the fixing button protruding on top of the TOCO probe into the hole of the fixing belt
to fix the TOCO probe. At this time, please adjust the degree of fastening through the
belt to make the TOCO value around 20 ∼ 90.
④ Press the zero point adjusting button to set up a reference value.

NOTE

If a TOCO probe is connected to the equipment but not used, unreliable values may
appear in the TOCO display area.

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2) TOCO screen
If the TOCO area on the screen is selected and touched, the following selection window
pops up on the screen:
① ②

① Title
TOCO: Displays only uterine contraction but not fetal movements
TOCO+ FM: Displays both fetal movements and uterine contraction simultaneously
② TOCO Zero value: Displays the reference value that appears when Zeroing has been
done
③ TOCO: Displays the degrees of uterine contraction

3) Setup
If the TOCO area of the screen is touched, the following selection window pops up on the
screen:

▣ Zeroing
This is used to adjust the zero point of TOCO. If this is touched, the TOCO value at the
moment will be set up as Offset value.

▣ Offset
This is used to set up a reference value to be used when adjusting the zero point of TOCO.
One of the values 0, 10, and 20 can be selected.

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▣ Auto Zeroing
This is a function for initiating automatic adjustment of the zero point when a TOCO value is
maintained below 0 for at least five seconds.

▣ Fetal Movement
This is used to set up whether to output fetal movement-related graphs to the screen or
through the printer.
If the value is “FMD+FM” or “FMD”, the title of TOCO will be displayed as “TOCO+FM” (if Off,
“TOCO”). Fetal Movements are displayed as Fetal Movement graphs, and automatically
detected Fetal Movements, as FMDs in the form of points.

<LCD Display>

<Paper Display>

▣ TOCO Color
This is used to set up TOCO values and Trace line colors.

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Chapter 7. Fetal movement measurement

Fetal Movements can be measured in two methods: automatic detections from data entered
in ultrasounds and measurement by pressing a marker jack when the patient feels fetal
movements.

▣Method using a marker jack

This is a method of recording fetal movements by relying on maternal perception for the time
points of fetal movements by having the patient press the button on the marker jack. When
the marker jack has been pressed, “|” will be displayed in the FHR waveform display area.

<LCD display>

<Paper display>

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▣ Marker jack

▣ Method using automatic fetal movement measurements

The automatic fetal movement measurements extract information in proportion to the sizes
and durations of fetal movement from the received ultrasonic Doppler signals and display the
information along with information on uterine contraction. In addition, if any of the obtained
values is larger than the preset critical value of the size of fetal movements, the values will be
marked as points in the UA waveform display area. Please refer to Chapter 9 (TOCO
measurement) on how to set up the critical value

▣ Setting the sound of Marker jack measurement

To turn ON/OFF the sound of pressing Marker jack, touch the Main Menu->System-> Marker
Sound.

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Chapter 8. Stimulator
When stimulator has been pressed, simulator symbol will be displayed on the screen.

<LCD display>

Warning

A stimulator can be used such as the GE stimulator or GE compatible

products.

Please use a safety secured stimulator.

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Chapter 9. Clinical Mark and Note

To record clinical mark in real time, use Clinical Mark button. When Clinical Mark key is
shortly pressed, Clinical mark will be entered, and Clinical Mark will be displayed when Trace
range and Real time is printed. Clinical mark will be displayed in Orange triangle and same
in Print. When Clinical Mark key is long pressed,, Note window will popup, and when one of
the lists is selected, related information will be displayed in Trace and Real time.

: Clinical Mark Key

Common
words Marker

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▣ Entering Note

When Clinical Mark key is long pressed, Note screen will be printed. Press OK after
selecting related item from the list, and Trace and Real time Note will be printed.

▣ Adding Note

Note lists can be added and edited by Users having Administrator rights. Touch Main menu-
>system->Edit Note and enter the Admin password, and then set the user environment using
New/Edit/Delete button.

However, the additional number of notes that can be saved is only 100.

NOTE

Preset four lists cannot be edited nor deleted.

To preset password, refer to Chapter 11, alarm and preset setting.

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Chapter 10. Trace

The saved measurement results may be viewed using the Trace function. Data measured for
72 hours are saved. Trace data can be reprinted or copied as images to USB

1) Trace area

⑥
⑦
⑧
①
②
③

②
③
③
④
⑤
④
⑤
⑤
⑥
⑥
① These are data for an area of 30~240bpm, which indicate the traces of fetal heart rates.
Markers or note entries are displayed at the bottom grids.
② FMD: Automatically detected fetal movements are displayed.
③ TOCO values in the range of 0~99 Units; ditto for graphs of fetal movements detected
from US.
④ Scroll bar: This is used to move the time point of Traces. Time points may be moved by
touching the scroll bar or by using the cursor movement key on the operation panel.
⑤ TOCO Zeroing: This indicates that TOCO Zeroing has been done.
The figure above shows Zeroing.
⑥ Grid: This indicates the standard of the grids.

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2) Trace

▣ Trace

To view trace data, touch Trace in the main menu.

: Trace Key

▣ Changing trace time

Trace data times may be changed by moving the scroll bar on Trace, by using volume
adjustment keys on the operation panel or by touching the left or right of trace window.

If US1 volume up key is pressed, the view will be moved to earlier 1 min; if US2 volume up
key is pressed, the view will be moved to later 1 min.

If US1 volume down key is pressed, the view will be moved to earlier 6 secs; if US2 volume
down key is pressed, the view will be moved to later 6 secs.

If the left side of LCD is touched, the view will be moved to earlier 10 min; if the right side of
LCD is touched, The view will be moved to later 10 mins.

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▣Exiting the Trace screen

To view data entered in real time when the Trace screen is displayed, touch the Main Home
of the Trace menu or the “screen switching or function key” on the operation panel.

: Home and function key

3) Setting up trace modes

Touch the menu in the Trace screen. The Trace menu will then appear.

▣ Print
Print 'Trace' data of a fixed duration. In this function, the device will print up to 1 hour of data
starting from the point of 'Trace' on the current screen. If the patient is discharged before the
1 hour mark, then only the data up to discharge will be printed.

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▣ Data Save

Trace a period of time, stored on a USB storage device. When you insert a USB storage
device is displayed on the LCD screen on the right. Trace mode from the main menu, touch
the “Data Save” button appears.

When "Data Save" is touched, data will be saved to USB. The first position of the Trace of
current screen will be saved as data image up to 4hrs 30min within one page. Duration will
depend on the print speed, 30 min for 3cm/min, 60 min for 2cm/min and 90 min for
10cm/min. In the situation of patient change, the data until before the change will be saved.

The following windows appear, approximately 10 seconds after the end of the progress bar
window disappears automatically. Data storage device recognition can be found at the
path ”\NewFC1400\data”.

The name of the file will be saved “{Patient ID}_{Patient

Name}_{YearMonthDayHourMinuteSecond}.jpg”.

Warning

Do not remove USB from the device during the data transportation.

▣ Main Home

The system will exit the Trace mode, and data will be output in real time.

Warning

Trace data is saved periodically by every 1 minute. Thus, up to 1 minute from

the end of data may not be saved. Additionally, no data will be saved if the
device is turned off within 1 minute of powering on.

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Chapter 11. Print

FC1400 has two Trace print function, real time and previous data print. In the printing
process, print icon can be seen on the right top. Two types of Print icons, 'printing' and 'print
stop', exist.

(Printing) (Not Printing)

To start or stop print, press the following Print key. For the normal start or stop print, press
the button for short. To accelerate the paper, press the key continuously and feed the paper.
When hand is removed from the key while feeding, max. 2.5cm will be additionally printed
and feeding will stop.

: Print start/Print stop key

1) Printing in real time

To print currently inputted data, touch the print icon on the operation panel or “Print Start” in
the menu. If any printing is in progress, a print icon will be displayed on the upper right side
of the screen.
To stop printing, touch the print icon on the operation panel again or touch “Print Stop” in the
menu.
When printing in real time has been stopped, paper will be fed in a certain length to be cut.
Printing in real time may be done in any of three speeds: 1, 2, 3 cm/sec.

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▣Changing the speed of printing in real time

To change the speed of printing in real time by the equipment, touch the main menu 
Printer. Touch the item “Speed” in the menu and select the desired speed to change the
speed.

Printing speeds will not be changed during a printing. To change the speed, stop the printing,
change the speed, and then print again.

▣Changing the type of printing paper

To change the type of paper, touch the main menu  Printer. Touch the item “Scale” in the
menu and select the desired type of paper to change the type

▣Changing the size of printing paper

To change the size of printing paper, touch the main menu  Printer. Touch the item “Size”
in the menu and select the desired size of printing paper to change the size.

▣Changing the grid line printing

To print grid line on the paper touch the main menu  Printer. Touch the item “grid” in the
menu. If the grid is on, the grid line is printed on the paper.

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2) Trend printing
To print trend data, please move to the point from which you want to print on the Trend
window and press Print. The trend will then be printed up to the next measurement or for the
time designated in advance. When trends are printed, the printing speed will be high at
25CM/sec.

3) Paper replacement
If the paper is off during printing, "No paper" alarm occurs.
If "No paper" alarm occurs, load paper or push "alarm silence" button to clear "no paper"
alarm status
You can open printer cover by pushing “Printer cover open” lever to the right. Load paper
with printable side up and close the cover.

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Chapter 12. Alarm and preset

Alarms are largely divided into patient condition alarms and product condition alarms.

1) Patient condition alarm

Patient condition alarms will sound when the value exceeds the maximum and minimum limit
values for alarms; there are two levels of alarms: Medium and Low. These differ in terms of
the order of ringing and volume.
Medium alarms will be shown as ** on the alarm list when they occur, and Low alarms, as *.
Certain alarms will occur after their set alarm delay time.
If more than one alarm sounds, alarm messages will appear successively on the alarm
condition window. An arrow next to an alarm message means that there is more than one
message.
If two or more alarms occur, the alarm at the highest level will sound.

A low-pitched sound will be

MEDIUM repeated three times and paused
for a while.
A low-pitched sound will be
LOW repeated two times and paused for
a while.

2) Product condition alarm

Product condition alarms inform the user that the monitor cannot operate properly and
indicate that the detections of dangerous conditions of the patient cannot be trusted.
There are several alarm sounds for product condition alarms.

When the connector is being

“Ding-dong”
disconnected

A low-pitched sound will be

Technical Alarm repeated one times and paused
for a while.

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3) Visual Alarm
Alarm messages appear in the Alarm Status Area on the screen. If more than one alarm
occurred, messages are changed every two seconds, with an arrow displayed next to the
messages. The colors of the alarm messages match the levels of the alarms. Medium
Alarms are displayed in red, Low Alarms, in yellow, and product condition alarms, in sky blue.
The asterisks next to alarm messages also match the levels of alarms. ** indicates medium
alarms, * indicates Low Alarms, and no asterisk indicates equipment condition alarms.
When a patient condition alarm occurs, the color of the numerical value in the numeral
window will be changed to red.
Visual Alarms will be maintained even after identifying the alarm statuses.

4) Alarm LED
There are two types of Alarm LED around the exterior to help checking the alarm condition
from far.

Yellow LED: Alarm occurred due to patient condition.

Medium Alarm: Flickering once a second.
Low Alarm: Stay on
Green LED: Alarm occurred due to Technical Alarm and stays on.

5) Audible Silence and Pause

When various alarms occur during the operation, this function is used to silence or pause
them, while the user is verifying the message. If “Alarm silence” button is clicked one time,
the device will go silence for 1 minute. If a new alarm occurs during the period, alarm sound
will ring again. If “Alarm silence” button is clicked twice, the device will go into “Pause” state
for 5 minutes. Under “Pause” no alarm will sound even if a new alarm is generated. If “Alarm
Silence” button is clicked three times, any sound alarm will be turned off and no sound will
be made even if a new alarm occurs.
Visual alarm will be displayed until the situation is resolved.
To silence the alarm, touch “Alarm silence” button on control panel.

: Alarm Silence Button

Warning
When monitoring patient conditions, do not rely solely on audible signals.
Reducing or turning off the volume of audible signals may endanger the
patient.

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6) Alarm Latching
Audible alarm will continue to ring until the situation is resolved. If no responsive action is
taken, it will continue to ring until the user takes an appropriate action. Once the user takes
action and alarm situation is over, both audible and visual alarm will disappear.

7) Alarm history
This is a function of making the history of Alarms that occurred visible. When the alarm
message area on the screen has been touched, an alarm history window will appear.
If the patient is admitted, the alarm history is cleared.

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8) Preset
It is a function which standard settings can be only changed by authorized person. Volume
adjusting function applies to current patient, and when device is restarted or moved to
another patient, it turns on to preset function value. But, if the device is turned off abnormally
and turned on within 30sec, it recognizes as same patient and maintains previous setting
value.

Preset function consists of alarm volume, alarm function usage, alarm range, alarm level,
alarm delay time, US1 Volume, US2 Volume.

To proceed alarm preset function, touch Main Menu->Preset.

As an authorized person only can set the function, enter the password in order to move to
setting menu.

WARNING

The initial Preset Password in Factory mode is “1234”. Change Preset

Password after installation to avoid use by unauthorized person. To change
the Preset Password, touch Main Menu->System->Change PW and enter
password. Please be aware, when the changed password is lost by users,
the only way to use the device is initializing to factory mode. When initialized,
all data will be removed. Please keep the password in safe place.

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9) Alarm volume adjustment

Audible Alarms can be adjusted to 1~5 levels of volume or may be muted.

① Touch "Main Menu->Preset->Alarm Volume"

② Selected the desired volume on the popup window.

③ Check if the current alarm volume is displayed on the alarm icon on the screen.

: Alarm Volume condition icon; to be set to levels 1~5

: Alarm Volume off icon; alarms occurring will not be heard

: Alarm silence

: Alarm pause

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10) Setting all alarms ON/OFF

This function is either to activate or deactivate alarm for each parameter. Touch Main Menu-
>Preset->Alarm On/Off and set the condition by pressing in Alarm Parameter window.
Default Value:
FHR1 : On
FHR2 : On

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11) Setting all alarms ranges

This function allows users to select alarm ranges for each parameter. Touch “Main Menu-
>Preset->Alarm Limit”, and click button on “Alarm Limit” window to change, in order to set
the default values, touch “Default” then select “OK” button.
Default Value:
FHR1 : 160~100 bpm
FHR2 : 160~100 bpm

12) Setting all alarm levels

This function allows users to select alarm levels for each parameter. Touch “Main Menu-
>Preset->Alarm Level”, and click button on “Alarm Level” window to change, in order to set
the default values, touch “Default” then select “OK” button.
Default Value :
FHR1 : Medium
FHR2 : Medium

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13) Default Setting

This function is used when setting values in “Alarm Parameter”, “Alarm Limit” and “Alarm
Level” sections to their default values. Click on the menu button to apply setting.
To set the Default value, touch "Main Menu->Preset->Default Setting". Refer Chapter 19 for
default value.

NOTE

When using the device through FC central, all setting values will be synchronized once
the device is out of main menu and parameter window.

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Chapter 13. Network

To set up network configuration, touch the Network in the menu.

 IP : NewFC1400 Network information

 Central IP : Central server information

 Wireless setting
If you use the Wireless LAN, wireless LAN module is inserted into the USB slot on the
rear side, and the touch the Wireless menu, and the touch the central menu
When “On” the wireless LAN function is activated. IP button then touch the screen that
appears depends. When “Off” wired LAN function works.
Using wireless LAN FCCentral II for more information, please refer to the separate
document on how to connect.

 Central setting
If you set the state “ON” by touching “Central” button, the device can be
connected to the Central. If you set the state “Off”, the connection will be
terminated.

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Warning

First, check the Wireless LAN module equipment to make sure that it is
properly seated, before Central of state and Wireless change “On”
Wireless is not set to "On" in unrecognized status.

 Changing the bed number

To change the Bed number, which is designed to identify the equipment, touch “Bed
Num” in the setting menu.
The Bed number can be selected from 1~16

NOTE

Wireless AP's ID are recognized only if using alphanumeric characters.

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Chapter 14. General setting

Go to “System” in the main menu to define the general settings.

=>
The following is the setting menu:

1) Date changing
To set up a date, touch the Date in the setting menu.

2) Time changing
To set up a time, touch the Time in the setting menu

3) Language changing
To set up a language, touch the “Lang” in the setting menu

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4) Version information
To verify the version information, touch the “version” in the setting menu

S/W Version
UI : UI Software version
F/W #1 : Fetal module firmware version
F/W #2 : Printer module firmware version
H/W Version
Digital : Digital board version
Analog : Analog board version

5) Changing the Touch volume

To change the volume of touch sound, please touch the “Touch Tone” in the setting menu.
The volume can be selected from Off and 1~5.

6) Demo operation
To operate the equipment as a demo, touch the Demo in the setting menu to set the demo
mode to On.

7) Edit Note
Touch for New/Edit/Delete of Note list. This function can be only used by administrator.
When correct Preset password is inserted, setting window will popup. Refer to Chapter 9,
Clinical Mark and Note, for more information.

8) Marker sound
Touch to turn ON/OFF the sound when clicking Marker. Refer to Chapter 7, Fetal movement
measurement, for more information.

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9) Factory
Only the administrator can enter Factory mode. In order to change the content, request for
A/S through Headquarter or agency.

10) Change Admin PW

Click this menu to change Admin password. For the initial touch, current Admin password
has to be entered and if it is confirmed, it can be changed by entering new and confirming
password.
Default Admin password is "1234".
Warning
Admin password cannot be recovered after change. If password is lost, reset
to Factory mode is the only way, and all the measured data and set values
will be lost. Please keep the password safe.

11) Volume range

Click this menu to change volume range. If you want the loudest than volume range 7 or the
quietest than volume range 0.

12) Changing the screen output mode

The screen supports two output modes: Graphic Mode and Text mode. To change a screen
output mode, please touch the “screen switching and function key” on the operation panel in
the main menu.

: Home and function key

13) Protocol Version

Set the version of protocol according to the version of FC Central. To use “Note”
function in FC Central, set the protocol version 1.2 and FC Central version 1.2.2 or
higher.

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Chapter 15. NST

The Non-Stress Test Timer measures the NST time that passed. This function helps users
measure for the designated time only.

1) NST measurement

▣ Starting NST
Touch “print key”. When the set NST time has passed, alarms will sound to inform the user
that the NST measurement has been finished.
To silence "NST ending" alarm, Touch “Alarm silence” button on control panel.

▣ Stopping NST
If Print key is touched, the current NST will stop. At this time, the printing will also stop.

2) NST Setting
Clicking “Main menu->Setting->Printer->NST” causes the following setting window to pop up.

▣ NST Time
This is used to set the NST Time.

The time period can be selected from OFF, 10, 20, 30, 40, 50, 60, and 90 mins.

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Chapter 16. CTG terms

CTG is interpreter function by FHR and TOCO.
If you choose on, base FHR values will be printed out 10 minutes after you press print
button. If you pressed print button after 10 minutes, CTG interpreter results will be printed
out.

1) Setting

▣ CTG Setting
Main Menu → Printer → touch CTG Print and when screen change as “CTG Print: On”, you
can print out CTG result.

▣ CTG turn off function

Main Menu → Printer → Touch CTG Print and when screen change as “CTG Print: Off”, it is
NOT printed out CTG result.

2) CTG Output

▣ Start CTG
When you start real time printing, you can find remarked CTG interim result on the top of
print paper after setting up CTG in every 10 minutes. If you want to print out CTG interim
result, you have to measure data at least 10 minutes. To remark certain CTG interim result
on the print, it is needed enough print paper blank for 10 minutes at least.

▣ Stop CTG

When you stop real time printing, you can find print of CTG final result after 5 seconds.

If you want to print out CTG final result, you have to measure data at least 10 minutes.

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3) CTG Measurement results

After measuring CTG, the result will be printed out as below.

Middle Report Final Report

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4) Glossary of CTG Terms

▣ Base FHR/ Average Base FHR
Except Constant FHR, irregular FHR, extreme changed FHR, 25bpm exceed of base line
difference cases, it should be progress more than 2 minutes as 10 minutes of FHR
average data.

▣ Number of TOCO
It is number of uterus contractions during measurement.

▣ High Episode/Low Episode

In case of under 30msec of changing width in 5 minutes is Low Episode and in case of
over 32msec of changing width in 5 minutes is High Episode.

▣ Short Term Variability

It is parameter about how fast fetal heart rate changed.
In case of under 2.6ms of STV result, it should be checked additionally when you think
about that fetal condition is unstable.

▣ Criteria Met / Criteria Not Met

When you get enough data to judge safe, it remarked as Criteria Met.
If it is NOT enough to judge unsafe, it remarked as Criteria Not Met.

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5) ACCELERATION
Visually apparent abrupt increase (onset to peak is < 30sec) of FHR above baseline.
Peak is ≥ 15 bpm. Duration is ≥ 15 bpm and <2 min. Peak of 10 bpm and duration 10sec is
acceleration

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6) LATE DECELERATION
Visually apparent gradual decrease (onset to nadir is ≥ 30 sec.) of FHR below baseline.
Return to baseline associated with a uterine contraction. Nadir of deceleration occurs after
the peak of the contraction. Generally, the onset, nadir and recovery of the deceleration
occur after same time as the onset, peak, and recovery of the contraction.

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7) EARLY DECELERATION
Visually apparent gradual decrease (onset to nadir is ≥ 30 sec.) of FHR below baseline.
Return to baseline associated with a uterine contraction. Nadir of deceleration occurs at
the same time as the peak of the contraction. Generally, the onset, nadir, and recovery of
the deceleration occur at the same time as the onset, peak and recovery of the contraction.

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8) Variable DECELERATION
Visually apparent abrupt decrease (onset to nadir is <30sec) in FHR below baseline.
Decrease is ≥15 bpm. Duration is ≥ 2 min and < 10 min.

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Chapter 17. Message list

1) Patient Alarm
Short Msg Figure Msg From
FHR* MEDIUM FHR* xxx < yyy FHR*
FHR* LOW FHR* xxx>yyy FHR*

2) INOP Alarm
Short Msg Figure Msg
No Paper Main
Low Battery Main

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Chapter 18. Simple troubleshooting

1) Troubleshooting and solutions
① If the probe comes off during operation, a “---” sign will be displayed, and a “Ding” sound
will be heard. In this case, check the connection condition of the probe and connect the
probe again to solve the problem.
② If paper has run out during operation, a “Paper off” sign will be displayed on the LCD
screen. In this case, please open the printer, check if the recording sheets have run out,
replenish the record sheets, and close the printer to solve the problem.

Warning

If Touch Calibration is not properly set, the system may not operate properly.
You must calibrate the touch input as written in the operation manual..

2) Performing periodic inspections

Just like all kinds of medical equipment, please conduct safety inspections on FC1400
periodically (once a year). Refer to the service manual provided by the company for the
inspection items.

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Chapter 19. Product specification

General
specification
Dimension 296(w)x.305.5(H)x97.5(D)(Approx. 2.9Kg)
Display 7” Wide (800 X 480)
Method : Thermal Array Print
Type : Roll type
Recorder Print speed : 1,2,3cm/min,( Real time)
30 cm/min (Trace, 2,4 cm/min setting)
20 cm/min (Trace, 1 cm/min setting)
Paper feeding function

Performance Specification
Input Signal : Ultrasound pulsed doppler
FHR detection method : Autocorrelation
Fetal Heart Rate FHR range : 50~210
FHR accuracy : 120~160 : ±1 bpm
Except 120~160 : ±2 bpm
Operating mode : PWD Mode
Transducer Type : 7-crystal
Ultrasound Transducer Ultrasound frequency : 1.0MHz
Pulse Repetition Frequency : 3125Hz
Spatial-Peak Temporal Average Intensity : <10mW/cm2
Input Source : External Transducer
Reference Control : One touch switch
Uterine Contraction
Auto zeroing
Measurement range : 0~99
Average Baseline FHR
Number of TOCO
Number of Acceleration
Auto CTG Analysis Number of Deceleration : Late, Early, Variable
High/Low Episode
Short term Variability
Signal Loss
* CTG Analysis results is printed out every 10 minutes
Data Storage Storage for 72 Hours

Power Specification
Power Input : 100~240VAC, 50~60Hz, 1.5A, Single phase
Li-ion : 4 hours ( charging)
Battery(Option)
2 hours(discharging)
External Link LAN, Wi-fi, USB,SD

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Default Alarm Setting

US1 ON
Alarm Parameter
US2 ON
Alarm Limit US1/US2 160 120
US1 Medium
Alarm Level
US2 Medium

▣ Intended Use
FC1400 is a fetus monitoring device used to measure Fetal Heart Rates (FHR), degree of
maternal uterine contraction (UA: Uterine Activity), fetal movements (FM). FC1400 shoots
ultrasounds to 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 the patient using a pressure sensor.
It indicates the fetal heart rates, maternal uterine activity, fetal movements, on its LCD screen
as figures and saves the information to its memory.

▣ Claimed indications
- Previous history of stillbirth
- Complications of pregnancy
- Induction of Labor
- Preterm labor
- Nonreassuring fetal status; fetal movement

▣ Contraindications : Unknown

▣ Monitor Environmental Specifications

· Operating Temperature： 15°C to 40°C (59°F to 104°F)
· Storage Temperature： - 10°C to 60°C (14°F to 140°F)
· Humidity： 20% to 95% RH
· Operating Attitude： 70(700) to 106Kpa(1060mbar)

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Appendix A. Manufacturer’s declaration - electromagnetic

immunity
The FC1400 system is intended for use in the electromagnetic environment specified belo
w.
The customer or the user of the FC1400 system should assure that it is used in such an
environment
Immunity test IEC 60601 Compliance level Electromagnetic
Test level Environment -guidance
Electrostatic dis 6 kV Contact 6 kV Contact Floors should be wood, c
charge (ESD) 8 kV Air 8 kV Air oncrete or ceramic tile. If f
IEC 61000-4-2 loors are covered with syn
thetic material, the relativ
e humidity should be at le
ast 30 %
Electrical fast 2kV for power supply li 2kV for power suppl Mains power quality shoul
Transient / burst nes 1kV for input/outp y lines d be that of a typical com
IEC 61000-4-4 ut lines 1kV for input/output l mercial or hospital enviro
ines nment.
Surge 1 kV differential mode 1 kV differential mod Mains power quality shoul
IEC 61000-4-5 2 kV common mode e d be that of a typical com
2 kV common mode mercial or hospital enviro
nment.
Power frequenc 3.0 A/m 3.0 A/m Power frequency magneti
y c fields should be at level
(50/60Hz) s characteristic of a typica
Magnetic field l location in a typical com
IEC 61000-4-8 mercial or hospital enviro
nment.
Voltage dips, sh <5% Uт (>95% dip in <5% Uт (>95% dip i Mains power quality shoul
ort Uт) for 0.5cycle n Uт) for 0.5cycle d be that of a typical com
Interruptions an mercial or hospital enviro
d 40% Uт (60% dip in U 40% Uт (60% dip in nment. If the user of the
Voltage variation т ) for 5 cycle Uт ) for 5 cycle system requires continue
s d operation during power
on power supply 70% Uт (30% dip in U 70% Uт (30% dip in mains interruptions, it is r
input lines т) for 25 cycle Uт) for 25 cycle e c om m e n d e d t h a t the
IEC 61000-4-11 system be powered from
<5% Uт (<95% dip in <5% Uт (<95% dip i an uninterruptible power s
Uт ) for 5 s n Uт ) for 5 s upply or a battery
Note: Uт is the a.c. mains voltage prior to application of the test level.

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The FC1400 system is intended for use in the electromagnetic environment specified bel
ow.
The customer or the user of the FC1400 system should assure that it is used in such an
environment
Immunit IEC 60601 Compliance level E l e c t r o m a g n e t i c environment -
y test Test level guidance
Conduct 3 Vrms 3 Vrms Portable and mobile RF communications
ed RF 150 kHz to 80 150 kHz to 80 MH equipment should be used no closer to an
IEC 6100 MHz z y part of the system, including cables, tha
0-4-6 n the recommended separation distance c
alculated from the equation applicable to t
he frequency of the transmitter.

Recommended separation distance

Radiated 3 V/m 3 V/m Recommended separation distance

RF 80.0 MHz to 2. 80.0 MHz to 2.5 G
IEC 6100 5 GHz Hz
0-4-3

Where P is the maximum output power rat

ing of the transmitter in watts (W) accordi
ng to the transmitter manufacturer and d i
s the recommended separation distance i
n meters (m).
Field strengths from fixed RF transmitters,
as deter-mined by an electromagnetic site
survey,
(a) Should be less than the compliance le
vel in each frequency range (b).

Interference may occur in the vicinity of

equipment marked with the following sym
bol:

Note 1) Uт is the A.C. mains voltage prior to application of the test level.

Note 2) At 80 MHz and 800 MHz, the higher frequency range applies.

Note 3) These guidelines may not apply in all situations. Electromagnetic propagation is af
fected by absorption and reflection from structures, objects and people.

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a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV bro
adcast cannot be predicted theoretically with accuracy. To assess the electromagnetic envi
ronment due to fixed RF transmitters, an electromagnetic site survey should be considere
d. If the measured field strength in the location in which the EUT is used exceeds the appli
cable RF compliance level above, the EUT should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the EUT.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V
/ m.
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and
the FC1400 system.
The FC1400 system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of the FC1400 system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the FC1400 system as
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum out Separation distance (m) according to frequency of transmitter
put
power (W) of transm 800 MHz to 2.5
150 kHz to 80 MHz 80 MHz to 800 MHz
itter GHz
0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended sep
aration distance (d) in meters (m) can be estimated using the equation applicable to the fr
equency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range a
pplies

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is af
fected by absorption and reflection from structures, objects, and people.

Immunity and Compliance Level

Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level
Conducted RF 3 Vrms, 150 kHz to 80 3 Vrms, 150 kHz to 80 3 Vrms, 150 kHz to
IEC 61000-4-6 MHz MHz 80 MHz
Radiated RF 3 V/m, 80 MHz to 2.5 3 V/m, 80 MHz to 2.5 3 V/m, 80 MHz to
IEC 61000-4-3 GHz GHz 2.5 GHz

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Guidance and manufacturer’s declaration - electromagnetic immunity

The FC1400 system is intended for use in the electromagnetic environment specified belo
w.
The customer or the user of the FC1400 system should assure that it is used in such an
environment
Immunit IEC 60601 Compliance le Electromagnetic environment -guidance
y test Test level vel
Conducte 3 Vrms 3 Vrms FC1400 system must be used only in a shiel
d RF 150 kHz to 80 150 kHz to 80ded location with a minimum RF shielding eff
IEC 6100 MHz MHz ectiveness and, for each cable that enters th
0-4-6 e shielded location with a minimum RF shield
ing effectiveness and, for each cable that ent
ers the shielded location
Radiated 3 V/m 3 V/m Field strengths outside the shielded location f
RF 80.0 MHz to 2. 80.0 MHz to 2. rom fixed RF transmitters, as determined by
IEC 6100 5 GHz 5 GHz an electromagnetic site survey, should be les
0-4-3 s than 3V/m.a

Interference may occur in the vicinity of equi

pment marked with the following symbol:

Note 1) These guidelines may not apply in all situations. Electromagnetic propagation is a
ffected by absorption and reflection from structures, objects and people.

Note 2) It is essential that the actual shielding effectiveness and filter attenuation of the s
hielded location be verified to assure that they meet the minimum specification.
a- Field strengths from fixed transmitters, such as base stations for radio (cellular/cordles
s) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be consi
dered. If the measured field strength outside the shielded location in which the EUT is use
d exceeds 3V/m, the EUT should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as rel
ocating the EUT or using a shielded location with a higher RF shielding effectiveness and
filter attenuation.

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※Description
1) Model name
(1) Model name: FC1400
2) Manufacturer’s company name and address
(1) Company name: Bionet Co., Ltd.
(2) Address: #1101 11F E&C Venture Dream Tower3, 38-21, Digital-Ro,31-Gil,Guro,
Seoul 08376, REPUBLIC OF KOREA
3) Manufacturing business permission number and manufacturing item permission number
(1) Manufacturing business permission no.:
4) Manufacturing item permission number:
Purpose of use of the manufacturing item: Device for combining maternal uterine
contraction and fetal heartbeats to show the conditions during parturitions
5) Manufacturing number, manufacturing date, and weight
(1) Manufacturing number: To be written at the back of the main body when selling the
product after obtaining item permission
(2) Manufacturing date: To be written at the back of the main body when selling the
product after obtaining item permission
(3) Main body dimension: 296(w)x.305.5(H)x97.5(D)
(4) Weight: 2.6 Kg
6) Other descriptions
(1) Electric/Mechanical indications
(A)Rated voltage: 100~ 240 VAC
(B)Frequency: 50/60Hz
(C)Power consumption: Max. of 50.4W
(2) Phrase indicating that the equipment is medical equipment: To be written in the
attached document
(3) Waterproof Level : Probe(IPX-1), Main equipment(IPX-0)
7) Position for attaching indications
At the back of the product after manufacturing

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Appendix B. Maintenance, Care, and Service

1) Mechanical hazard

Warning

Ultrasound probes are highly sensitive medical instruments that can easily be
damaged by improper handling. Use care when handling and protect from
damage when not in use.
DO NOT use a damaged or defective probe.
DO NOT drop the probes or subject them to other types of mechanical shock
or impact.

Warning

A defective probe or excessive force can cause patient injury or probe

damage:
•Observe depth markings and do not apply excessive force when inserting or
manipulating intercavitary probes.
•Inspect probes for sharp edges or rough surfaces that could injure sensitive
tissue.
•DO NOT apply excessive force to the probe connector when inserting into
the probe port. The pin of a probe connector may bend.

2) Biological hazard

Warning

To avoid the risk of disease transmission:

• Must use protective barriers (gloves and probe sheaths) . Follow sterile
procedures when appropriate.
• Thoroughly clean probes and reusable accessories after each patient
examination and disinfect or sterilize as needed.
• Follow all infection control policies established by your office, department
or institution as they apply to personnel and equipment.

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3) Electrical hazard

Warning

In case Gel contacts internal electronic device, Defective probe may cause
electrical shock.
Prior to each use, visually inspect the probe lens and case area for cracks,
cuts, tears, and other signs of physical damage.
DO NOT use a probe which appears to be damaged until you verify functional
and safe performance.
Perform a more thorough inspection, including the cable, and connector, each
time you clean the probe.
DO NOT kink, tightly coil, or apply excessive force on the probe cable.
Insulation failure may result.
warning: To avoid risk of electric shock, this equipment must only be
connected to a supply mains with ground
Do not modify this equipment without authorization of the manufacturer
If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of equipment
Do not to touch signal input, signal output or other connectors, and the
patient simultaneously.
Refer servicing to qualified personnel of Bionet Co., Ltd.
Power supply is specified as a part of ME Equipment.

4) Probe acoustic output hazard

Warning

Ultrasound can produce harmful effects in tissue and potentially result in

patient injury. Always minimize exposure time. And keep ultrasound levels low
when there is no medical benefit.

5) Probe head waterproof

Mandatory Action

From US probe bottom to 2~3 cm, waterproof IPX is possible. Do NOT

immerse the probe bottom into any liquid beyond 2~3 cm from probe bottom.
Never immerse the probe connector into any liquid.

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Appendix C. Ultrasound Power

Use of Diagnostic Ultrasound
The American Institute of Ultrasound in Medicine (AIUM) has published a document entitled
"Medical Ultrasound Safety".
This three part document covers Bioeffects and Biophysics, prudent Use and Implementing
ALARA.
Ultrasound users should read the AIUM documents to become more familiar with Ultrasound
safety. A copy of this document is included as part of the documentation package (Document
2163920-100).

AIUM
14750 Sweitzer Lane
Suite 100
Laurel, MD, USA 20707-5906
telephone 1-800-638-5352.

In accordance with US FDA Guidelines, the overall maximum acoustic SPTA intensity for the
product is limited to 100 mW/cm^2 and MI is limited to 1.0.

1) Measurement Precision and Uncertainty

Center Acoustic Peak Acoustic
Frequency Power Rarefractional Intensity
Pressure
Measurement ± 2 % ±5% ±15% ± 25%
Uncertainty

2) Maximum Output Summary

Operating Mode DOP Probe
Pulsed Doppler O
Mode

3) Maximum Probe Temperature (Degrees C)

Probe Max Temperature
With TMM In Air Mode
Phantom
US 33.2 21.6 PWD Mode
Lens temperature monitored for 30 min.
Measurement uncertainty: +-0.5 degree C.
Ambient temperature : 22.1 degree C

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4) Table Key
IEC FDA Meaning IEC60601-2-37 / FDA&NEMA UD2,UD3
α a Acoustic Attenuation Coefficient / Derating factor
(usually 0.3 dB/cm-MHz)
Aaprt Aaprt -12db Output Beam Area / Active aperture area
CMI - Normalizing Coefficient
Deq Deq Equivalent Aperture Diameter
d-6 d-6 Pulse Beam Width / Beam diameter at –6 dB
deq deq Equivalent Beam Diameter
ƒawf fc Acoustic Working Frequency / Center frequency
Ipa Ipa Pulse-Average Intensity
Ipa,α Ipa.3 Attenuated Pulse-Average Intensity
Ipi PII Pulse-Intensity Integral
Ipi,α PII.3 Attenuated Pulse-Intensity Integral
Ita(z) ITA Temporal-Average Intensity
Ita,α(z) ITA.3(Z) Attenuated Temporal-Average Intensity at depth z
Izpta(z) ISPTA(Z) Spatial-Peak Temporal-Average Intensity
Izpta,α(z) ISPTA.3(Z) Attenuated Spatial-Peak Temporal-Average Intensity
MI MI Mechanical Index
P Wo Output Power / Time average acoustic power at the
source
Pα W.3(Z) Attenuated Output Power / Time average acoustic
power derated to depth z
P1 Wo1 Bounded Output Power / Power emitted from the
central 1cm of aperture
pi PII Pulse Pressure Squared Integral / Pulse intensity
integral
pr pr Peak-Rarefactional Acoustic Pressure
prα pr.3 Attenuated Peak-Rarefactional Acoustic Pressure
prr PRF Pulse Repetition Rate / Pulse repetition frequency
TI TI Thermal Index
TIB TIB Bone Thermal Index
TIC TIC Cranial-Bone Thermal Index
TIS TIS Soft-Tissue Thermal Index
td PD Pulse Duration
X, Y x-12,y-12 -12 dB Output Beam Dimensions
Z Z Distance from the Source to a Specified Point
Zb Zsp Depth for TIB / Depth at which the relevant index is
maximum
Zbp Zbp Break-Point Depth
Zs Zsp Depth for TIS / Depth at which the relevant index is
maximum

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Acoustic Output Tables

MC65R1S – Pulsed Doppler Mode
Index MI TIS TIB TIC
scan Non-scan Non-scan
Aaprt<= 1 Aaprt
>1
Global Maximum : Index Value 0.0164842 - 0.00168143 - 0.0130577 0.00869565
IEC FDA Unit
Associated pra pr.3 (MPa) 0.0164807
Acoustic P Wo (mW) - 0.4 0.4 0.4
Parameter min of min of (mW) -
[Pα(zs), [(W.3(Z1),
Ita,α(zs)] ITA.3(z1)]
zs z1 (cm) -
zbp zbp (cm) -
zb zsp (cm) 1.8 1.8
z at zsp (cm)
max.
Ipi,α
deq(zb) deq(zsp) (cm) 1.0865
ƒawf fc (MHz) 0.999572 - 0.999572 - 0.999572 0.999572
Dim of X (cm) - 0.4 - 0.4 0.4
Aaprt Y (cm) - 0.4 - 0.4 0.4
Other td PD (μsec) 59.9647
Information prr PRF (Hz) 3906
pr at pr@PIImax (MPa) 0.0175374
max. Ipi
deq at deq@PIImax (cm) 1.0865
max. Ipi
Focal FLX (cm) - 2 - 2
Length
FLY (cm) - 2 - 2
Ipa,α at IPA.3@MImax (W/cm^2) 0.00154839
max. MI
Operating Frequency (MHz) 1.0 - 1.0 - 1.0 1.0
Control
Conditions

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Appendix D. Abbreviation and Symbol

Abbreviation and Symbol of manual or system operation is arranged in alphabetical order.

Abbreviations
A
AC alternating current

C
C Celsius
cm, CM centimeter

D
DC direct current

E
EMC electromagnetic compatibility
EMI electromagnetic interference
F
F Fahrenheit

G
g gram
H
HR heart rate, hour
Hz hertz
I
Inc incorporated
J

K
kg, KG kilogram
L
L liter, left
lbs, LBS pounds
LCD liquid crystal display
LED light emitting diode
M
M mean, minute
m meter
MIN, min minute
MM, mm millimeters
MM/S millimeters per second
MMHG, mmHg millimeters of mercury
mV millivolt
N

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S
sec second
T
Temp, TEMP temperature
U

V
V volt
W

X
X multiplier when used with a number (2X)

Symbols
& and
° degree(s)
> greater than
< less than
– minus
# number
% percent
± , +/- plus or minus

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Product Warranty

Product name Fetus monitoring device

Model name FC1400

Item permission
number
Item permission date

Manufacturing no.

Warranty period 1 year from the date of purchase

Date of purchase MM / DD / YY

Hospital name:
Customer Address:
column Name:
Phone:

Seller name

Manufacturer name

※This product is “medical equipment.”

※Thank you for buying FC1400
※This product has passed thorough quality control and strict inspections.
※The criteria for compensation in relation to repair, replacement, or refund for this product
shall be governed by the “consumer damage compensation regulations” announced by the
Ministry of Strategy and Finance.

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International Sales & service

Bionet Co., Ltd.
#11F, E&C DREAM TOWER III, 38-21, Digital-Ro 31-Gil,
Guro-Gu, Seoul, South Korea (ZIP. 08376)
Tel: +82-2-6300-6418 / Fax: +82-2-6300-6454 / e-mail: [email protected]
Website: www.ebionet.com

U.S.A. sales & service representative

Bionet America, Inc.
2691, Dow Ave, Suite B
Tustin, CA 92780 U.S.A.
Toll Free: 1-877-924-6638 / FAX: 1-714-734-1761 / e-mail: [email protected]
Website: www.bionetus.com

European sales & service representative

MGB Endoskopische Geräte GmbH Berlin :
Schwarzschildstraß e 6
D-12489 Berlin, Germany
Tel: +49(0)306392-7000 / Fax: +49(0)306392-7011 / e-mail: [email protected]
Website: www.mgb-berlin.de

Bionet Co., Ltd.

Model Name: FC1400

[Document Number : ICF-1207-201]

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