FC-1400 Operation Manual FC-1400 OPERATION MANUAL · FC-1400 Operation Manual FC 1400 Operation manual. Rev. 1.2 3 How to reach us … The following are telephone numbers and addresses

FC-1400 Operation Manual

FC-1400

OPERATION MANUAL

Rev. 1.2


FC 1400 Operation manual. Rev. 1.2 2

Terms of Warranty

- This product is manufactured and passed through strict quality control and

inspection.

- Compensation standard concerning repair, replacement, refund of the product

complies with “Consumer’s protection law” noticed by Economic Planning Dept.

- We provide a 1-year warranty period for main body, but Accessory provides a

6 months warranty period.(2 years in Europe)

- We will repair or replace any part of the FC-700 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.

Caution

Federal law restricts this device to sale by or on the order of a physician



How to reach us …

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

supplies and sales personnel

Purchase Inquiry

GIMA SPA VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : [email protected]

Manufacturer Bionet Co., Ltd. #11F, E&C DREAM TOWER III, 197-33, GURO-DONG, GURO-GU, SEOUL, SOUTH KOREA (ZIP 152-050) Overseas sales dept. Tel : +82-2-6300-6418

Service call

VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : [email protected]

Technical support

For any technical questions or problems on the equipment, call; VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : [email protected]

Web site

URL : http://www.gimaitaly.com URL : http:// www.ebionet.com

※ In the event of a malfunction or failure, contact Service Dept. of GIMA SPA along with the

model name, serial number, date of purchase and explanation of failure.



Definition of Warning, Caution, Note

For a special emphasis on agreement, terms are defined as listed below in operation

manual. Users should operate the equipment according to all the Warning and Caution

instructions.

Manufacturer or Sales agency takes no responsibility for any kind of damage or

breakdown that is caused by misuse and failure to maintain the equipment.

Warning

Be informed that it may cause serious injury or death to the patient, property damage, material losses against the “Warning” sign.

Caution

Be informed that it may cause no harm in life but lead to injury against the “Caution” sign.

Note

Be informed that “Note” sign is used for notifying some important contents relating to installations, use, maintenance for users, but not dangerous.



General Precaution on Environment

Do not keep or operate the equipment in the environment listed below.

Avoid placing in an area exposed to moist. Do not touch the equipment with wet hand .

Avoid exposure to direct sunlight

Avoid placing in an area where there is a high variation of temperature. Operating temperature ranges from 10C to 40C. Operating humidity ranges from 30% to 85%.

Avoid in the vicinity of Electric heater

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

Avoid placing in an area where there is an excessive shock or vibration.

Avoid placing in an area where chemicals are stored or where there is in danger of gas leakage.

Avoid dust and especially metal material into the equipment

Do not disjoint or disassemble the equipment. GIMA SPA takes no responsibility of it

Power off when the equipment is not fully installed. Otherwise, equipment could be damaged.



General Precaution on Electric Safety

Check the items listed below before operating the equipment.

- Be sure that power supply line is appropriate to use.

(Power Adaptor Input : 100 - 240V AC, 50-60Hz, 1.2A, Output : 18V, 2.5A).

- Be sure that the entire connection cable of the system is properly and firmly fixed.

Note

The equipment should not be placed in the vicinity of electric generator, X-ray,

broadcasting apparatus to eliminate the electric noise during operation. Otherwise, it may

cause incorrect result.

Self-power line is important for FC-1400. To use same power source with other electric

instruments may cause incorrect result.

Note

FC-1400 is classified as listed below ;

- This equipment conforms to Class II, Type-BF.

- Do not use the equipment in the vicinity of flammable anesthetics and solvents.

- The equipment conforms to Class I according to IEC/EN 60601-1 (Safety of Electric

Medical Equipment)

This equipment conforms to Level B according to IEC/EN 60601-1-2 (Electromagnetic

Compatibility Requirements)

Note

Accessory equipment connected to the analog and digital interfaces must be certified

according to the respective IEC standards ( e.g. IEC 950 for data processing equipment

and IEC 601-1 for medical equipment ). Furthermore all configurations shall comply with

the system standard EN 60601-1-1:1993.

If in doubt, consult the technical service department or your local representative.



Safety Symbols

- The International Electrotechnical 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.

.

Save these instructions.

Symbols contents

Power Adaptor Input Connector

Refer to accompanying documents

Patient Marker lnput Connector

External Singnal IN/OUT Port

ISO lated patient connection (IEC 60601-1 Type BF)

Stand by



Table of Contents

Terms of Warranty 2

How to reach us 3

Definition of Warning, Caution, Note 4

General Precaution on Environment 5

General Precaution on Electric Safety 6

Safety Symbols 7

Chapter 1. Introduction 10

1) Overview 10

2) Features 10

3) Configuration 11

4) Description 12

5) Display Screen 16

6) Description of Operation panel 18

7) Power 20

8) Description of Print form 21

9) CTG Analysis Results Report 22

10) Installation 23

Chapter 2. How to Use FC -1400 25

1) Basic Instruction 25

2) Tracing the saved data 26

3) FHR(Fetal Heart Rate) Measurement 27

4) UA Measurement 30

5) Fetal Movement Measurement 30

6) Print 30

7) Alarm Sound 30

8) Volume Adjusting 30

9) Warning Message 31

10) Battery replacement (option) 31



Chapter 3. Setup 32

1) Alarm/FHR setup 32

2) TOCO/FM setup 33

3) Print/Screen setup 34

4) Patient I.D setup 35

5) Time and Date setup 36

6) Screen Brightness setup 37

Chapter 4. CTG Terminology 38

Chapter 5. Trouble shooting 41

Chapter 6. Specifications 43

Product Warranty 45

Without prior notice, the specifications and functions are subject to change to enhance the product in this manual.



Chapter 1. Introduction

1) Overview

FC-1400 is a fetal monitors, providing continuous monitoring, display, and recording of fetal

fetal heart rate(FHR), fetal movement(FM), and uterine activity(UA) for antepartum testing

and monitoring. FC-1400 irradiates the ultrasound wave to maternal abdomen, and detects

the Doppler effect signal reflected from the heart of the fetus. FC-1400 extracts FHR and FM

from this signal and provides the fetal heart beat sound with internal speaker. FC-1400

measures the uterine activity of a pregnant woman using toco sensor. FC-1400 displays

FHR, UA and FM with waves and numbers on the color LCD screen and saves them in

internal flash memory.

2) Features

1. Measures Fetal Heart Rate and Fetal Movement simultaneously.

2. Using the US probe for twins, measuring FHR and FM of twins is possible. (Optional)

3. Traces the saved data on the color LCD screen without wasting the record paper.

4. Prints the data you select during tracing the saved data at high speed.

5. Provides the clear heart beat sound and the accurate FHR because of the robust

ultrasound probe which endures noise.

6. Since it adopted 9-crystal and 1Mhz extending irradiation area, the discontinuity of FHR

minimized even during patient’s moving.

7. Detects and print fetal movement automatically analyzing Doppler effect signal.

8. Prints Grid and signals simultaneously when using Fax paper.

9. Provides RS-232 to communicate with the central delivery monitoring system.

10. Using the rechargeable battery, constant delivery monitoring is possible in lights-out

case. (Optional)



3) Configurations

FC-1400 consists of the following. Unpack the package and check the followings are

included. Also, be sure to check any damage to the main body and accessories.

▣ Default

① FC-1400 main body

② US Probe (1EA)

③ TOCO Probe (1EA)

④ Patient Marker (1EA)

⑤ Record Paper (2EA)

⑥ Power Adapter (1EA)

⑦ Power Cord (1EA)

⑧ Ultrasound Gel (1EA)

⑨ Probe Belt (2EA)

⑩ Manual (1EA)

▣ Optional

① US Probe for twins (1EA)

② Probe Belt (1EA)

③ Rechargeable Battery (1EA)



4) Description

General▣

① ⑥

②

⑤ ④ ③

① Main Body

② TOCO Probe

③ US Probe

④ US Probe for twins ( Optional )

⑤ Patient Marker

⑥ Power Adaptor



Top view▣

① ②

③ ④

① Printer door : Opens when replacing record paper.

② LCD display Screen : Shows the measured data and the status of equipment.

③ Hand grip : Use when lifting and moving the equipment

④ Control panel : Controls the functions.



Front view▣

Printer door release button: Slide button to open printer door

Rear view ▣

① ② ③

① Power adaptor connector: Power adaptor of 18V, 2.5A is connected

② RS-232 Connector: Standard 9-pin male RS-232 connector

③ Patient Marker Connector

Warning

Do not contact RS-232C connector and patient at the same time.



Left side view▣

Hand Grip : Use when lifting and moving the equipment

Right side view▣

① ② ③

① US Probe connector: for single-fetus monitoring

② US Probe connector: for twin-fetus monitoring

③ TOCO Probe connector: for maternal abdominal contractions monitoring

Note

To avoid an expected electric shock, do not open the equipment cover or disassemble the

equipment. . Please do not use the device when the probe is damaged. Refer servicing

to qualified personnel of GIMA SPA



5) Display Screen

Description of Main Monitoring Screen▣

⑧ ⑦ ⑥ ① Setting the location of base line of FHR wave ② Screen Contrast setting menu ③ Power Status Area ④ FHR numeric area

- Display FHR numeric - Display Heart Rhythm and signal level - Display speaker volume status - Display alarm On/Off - Display offset value when detecting heart beat of twins-fetus

⑤ TOCO numeric area - Display relative value of UA - Display On/Off of automatic FM detecting - Display the base line of UA

⑥ Printer setting menu ⑦ Patient ID setting menu ⑧ Time and date setting menu ⑨ Marking area of UA and the degree of FM in wave

- FM1, FM2: Fetal Movement, Wave that shows the degree of FM - FMD1, FMD2: Fetal Movement Dot, Mark in dots when the intensity of FM exceeds the set value.

- +10: Show the UA reference value ⑩ Clinician Mark marking area ⑪ Patient Mark marking area ⑫ FHR Wave marking area

- +20: 20 added in FHR waves

③ ②

④

⑤

⑨

⑩

⑪

⑫

①



Monitoring Mode▣

US1 Connected

US2 Connected

TOCO Connected

US1 Connected

US2 not Connected

TOCO Connected

US1 not Connected

US2 Connected

TOCO Connected

US1 not Connected

US2 not Connected

TOCO not Connected



6) Description of Operation Panel

⑨ ⑩ ③ ④

② ①

⑤ ⑥ ⑦

① Power On/Off Button

- Turn on/off the power of the main body

② Volume adjusting button

- Press the button and select a channel of which volume needs to be adjusted in US1

and US2.

- Adjust the volume of selected channel by turning the knob.

③ Zero point adjusting button of UA

- Press the zero point adjusting button and set up the base line after putting TOCO

probe on the abdomen of a pregnant woman.

④ Button for tracing the saved data

- Trace the saved data on the screen.

⑤ Alarm On/Off Button

- You can set up the alarm on/off.

⑥ Clinician Mark Marking Button

- It is used when a nurse or a doctor wants to mark it.

⑦Print Start/Stop Button

- You can record data on paper in real time in monitoring mode .

⑧



- You can print data on paper at high speed in tracing mode.

⑧ Trim Knob

- Turn the knob right or left or press it like a button.

- In monitoring mode, you can select the menu and change system settings.

- In tracing mode, you can search the saved data.

⑨ Battery power usage indication light

- It lets you know that you are running the device by using battery.

⑩ DC power usage indication light

- It lets you know that you are running the device by using power adapter.



7) Power When DC is connected to the device, DC power indication light turns light green and when

battery is installed inside, it automatically starts to charge the battery.

When you turn on the device without DC power, battery provides power and the remains of

battery is showed in “Power Status Area” of screen.

When battery has a power lack, it alarms consecutive 3 times and shows battery capacity

shortage warning message on the screen. Connect DC cable as soon as possible and

charge the battery.

If you don’t connect DC cable within 1 minute after battery capacity shortage warning, the

device automatically turns off.

Battery charging and discharging time are as follows

●Charging time when the device is running: 14 hrs.

●Charging time when the device turns off: 6 hrs 30mins.

●Consecutive Battery Using time: 2 hrs 30mins.

The device has a built-in battery so that date and time can be saved even after turning off

the power. It uses Type CR2032 3V Lithium Battery.

Note

To protect the environment, please do not dispose batteries but request at medical

engineering department and follow the appropriate process to dump at designated spots.



8) Description of Print Form

① FHR wave of US1, US2

② When a woman pressed Patient Marker, it shows when the marker is pressed.

③ When a nurse or a doctor pressed Clinician Mark button of the device, it shows

when the button is pressed.

④ It shows when the zero point adjusting button is pressed.

⑤ Analyze Doppler signals of US1 channel and show automatically detected degree

and duration of FM

⑥ UA in waves

⑦ Mark the degree and duration of FM automatically detected by analyzing Doppler

signals of US2 channel

⑧ Detecting time

⑨ Mark printing intervals. 1cm/min: Print data of 1 minute in 1 cm

⑩ ID of patient

⑪ Software Version

⑫ Show FHR offset of US2 channel

⑬ Dot of fetal movement

⑭ Fetal Movement Ggaph on/off

Thickness of the US1 , US2 Line



9) CTG(Cardio-Toco Graph) Analysis Results Report (Option)

- Period : Time during which CTG analysis was performed

- Average Baseline FHR(bpm) : Average number of Baseline FHR during the analysis

period

- Number of UC : Number of UC and frequency of UC per hour during the analysis

period

- Acceleration : Number of acceleration and frequency of Acceleration per hour during

the analysis period

- Deceleration: Number of DEC and frequency of DEC per hour during the analysis

period

- Late DEC : Number of Late Deceleration during Deceleration

- Early DEC : Number of Early Deceleration during Deceleration

- Variable DEC : Number of Variable DEC during Deceleration

- High Episode : High episode is when the minute range exceeds 32ms for at least 5

out of 6 consecutive minutes.

- Low Episode : Low episode is when the minute range is under 30ms for at least 5

out of 6 consecutive minutes.

Middle Report Final Report



- Short term variability : A measure of the micro fluctuations of the FHR

When the STV is less than 2.6ms, it is strongly recommended that additional tests

must be performed to verify the status of the fetus.

- Criteria MET : It means if FC1400 has found enough evidence that the trace is

reassuring

- Criteria NOT MET : It means if FC1400 has not found enough evidence that the

trace is reassuring

10) Installation

Suggestions for installation▣

Please keep in mind those listed below when installing FC-1400.

① Temperature: 10 to 40 Humidity: 30 to ℃ 85％

② Check the connection of power cord and be careful with Probe Cable.

③ Do not connect several cords to one electric outlet.

④ Put the device on flat surface.

⑤ Do not use an electric cord, which generates connecting noise.

⑥ All the setting is recorded in the internal memory even after turning on and off the

device.

⑦ Be careful since it’s fragile.

Install the device considering temperature and humidity and keep it away from dirt or the

inflammables.

Connect Power ▣

The product uses power adapter. The input of the adapter is DC 100 to 250V, 50-60hz, 1.2A

of free voltage and output is 18V, 2.5A. Plug the input cord of adapter into power plug and

connect the output cord into the device.

Connect Cable▣

There are three types of cable, US probe cable, TOCO probe cable, Patient Marker cable.

Connect US probe cable to US1, US2 on the right side of the device, connect TOCO probe

cable to TOCO connector on the right side of the device. To avoid any confusion, US probe

cable and TOCO probe cable have grooves in different direction. Connect Patient marker

cable to MARK connector on the back side.



Note

When US or TOCO cable is connected the power of device must be turned off

Installing printing paper▣

You can open printer cover by pushing “Printer cover open” button to the right. Load paper

with printable side up and close the cover.



Chapter 2. How to use?

1) Basic Instruction

① Connect power cable to the device and press the power button.

② Make sure that all the settings are as you want.

③ Change the settings as you would like.

④ 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.

⑤ Fix TOCO probe on Fundus which is located 10 cm above the belly button of the

maternal abdomen using a fixing belt.

⑥ Give Patient Marker to the woman and let her press it when she feels the movement of

fetus.

⑦ Press “zero point adjusting button” and set up a base line of UA.

⑧ Adjust speaker volume so that you can hear fetal heart beat clearly.

⑨ Start to record on paper by pressing “Print” button when accurate heart rate shows up on

the screen.



2) Tracing the saved data

If power switched on, FHR, UA and FM data is saved in the memory automatically and you

can trace the saved data on the screen. Follow the steps.

① Press the tracing mode button in monitoring mode and icon pops up on the top left

of the screen and you go into search mode.

② Begin to trace the data by turning the knob left/right.

③ If you turn the knob quickly, it automatically scrolls to the direction you chose before you

press the knob button. Press the knob to stop automatic scrolling.

④ Press “Print” button in tracing mode and it prints the current screen at high speed.

⑤ Press the tracing mode button again and it returns to the current monitoring screen,



3) FHR Measurement

It gets fetal heart sound by using ultrasound Doppler effect and calculates heart rate by

minutes and saves it. Please get rid of air layer by putting enough of ultrasound gel on US

probe to avoid diminution of ultrasound in the air.

Connection of the US probe▣

Connect US probe to US1 and US2 terminal on the right side of the device.

Basic operation according to connection Probe▣

If US probe is not connected to the device, you will see “US1 off” and “US2 off” in FHR

marking area. When US probe is connected to US1, you will see “US1 ---“ in FHR marking

area which means FHR detecting is ready. When US probe cable comes off the device, you

will see “US1 off”.

FHR Measurement▣

① Put a fixing belt under the waist of the woman in the state of maternity.

② Put enough of ultrasound gel on US probe to get rid of bubble between the maternal

abdomen and the surface of US probe.

③ Find fetal back by fumbling the maternal abdomen and place US probe on it. Place US

probe as the picture below when fetus is looking right and left.

Note

When the Doppler Probe is put not on the back but on the breast part of a fetus, accurate ultrasonic waves can’t be caught from the fetal heart and the fetal heat beat can be frequently missed.

④ Place US probe where you can hear fetal heart beat quite loudly and clearly, the heart

turns on green LED in FHR marking area and blinks to fetal heart beat and adjust

speaker volume suitably.



⑤ Stick the button on the top of US probe to the fixing belt hole and fix it to avoid slipping of

US probe.

Note

Fix the Probe Cable toward the head part of a pregnant woman in order to prevent it from being damaged, and for moving to some degree comparatively.

⑥ It takes 2~4 seconds for FHR to be calculated and shown.



4) UA Measurement

You can detect UA by using pressure sensor externally sticked. Put TOCO probe on the

maternal abdomen and it detects the relative pressure which changes as the maternal

abdominal contraction and record UA.

Connection of TOCO probe▣

Connect TOCO probe to TOCO connector on the right side of the device.

Basic operation according to connecting Probe▣

If TOCO probe is not connected to the device, you will see “TOCO off” in TOCO marking

area. If you connect TOCO probe to the device, you will see “TOCO” in the area and it is

ready to detect UA. When you see FM(Fetal Movement), it shows “TOCO+FM”.

UA detecting▣

① Place the fixing belt under the woman’s back.

② Place TOCO probe on the top of the maternal abdomen (Fundus: 10 cm above the belly

button) or on the spot which starts to harden first.

③ Stick the fixing button sticking out of the upside of TOCO probe to the hole of fixing belt

and fix TOCO probe. Please set the TOCO at 20 ~ 90 to fasten.

④ Set a base line by pressing zero point adjusting button.

Note

If the UC Probe is connected to the equipment but not used, unreliable value may be indicated on the UC indication section.



5) Fetal Movement measurement

Using Patient Marker▣

It is designed to record the occuring moment of FM by the woman’s acknowledgement of it.

When the woman press mark jack after having the quickening of the womb, you will see “|” in

FHR wave marking area.

Automatic Detaction▣

Automatic FM detecting extracts information from Doppler signals in proportion to the

intensity and the time of FM and shows it on the screen with UA. When it exceeds the setting

value, you will see dots in UA marking area. Please see 3. 2 for set-up.

6) Print

Real time printing function has AUTO NST (NON-Stress Test)printing function and

Monitorting printing function. AUTO NST printing function is effective for un UA test and prints

FHR, UC and FM on paper and automatically stops. User can start and stop to record in

Monitoring Printing Function. Please see Printing set up in 3, 3,

7) Alarm Sound

Alarm sound occurs when FHR goes beyond the previously set normal FHR upper limit and

lowest limit and exceeds the alarm delay time. Please use the alarm button on operation

panel for alarm On/Off. Please see 3.1 for Alarm setting.

8) Volume Adjusting

You can hear FHR sound detected by US probe through built-in speaker and adjust volume

by choosing US1, US2 by pressing volume control button and turning the knob. Volume has

16 sound levels from 0 to 15. Press volume control button again.



9) Warning Message

It notifies you with sound in situations listed below when using the device.

① When US cable is came off the device in use,

② When running out of paper in printing the message” ” pops up.

③ When turn on/off the power

When changing and saving settings

10) Battery replacement (Option)

Rechargeable battery of this device uses NiMH type of 12V, 2600mA. Charging time is 6

hours and usable for 2 hours. This battery is consumable thing so that it must be replaced

every 6 months or use over 500 times. When battery replace, contact agency or service

center of GIMA SPA.

<Battery > <DC>



Chapter 3. Setup Modes

1) Alarm/FHR Setup

U/S CONFIGURATION

ALARM

FHR LOW

FHR HIGH

DELAY TIME

LINE COLOR

US 1

US 2

GUIDE

US2 OFFSET

OFFSET

120 BPM

160 BPM

20 SEC

20

US1

140

US1

US2 ( + 20 )

140

TOCO + FM

30 (10) 01/JAN/00 00:02:21 123456789 3cm/min

① Turn the knob and select FHR marking area in monitoring mode and press the knob and US Configuration box pops up.

② Turn the knob and select FHR Low. Turn the knob, set lowest limit of alarm and press the knob.

③ Turn the knob and select FHR high. Turn the knob, set upper limit of alarm and press the knob.

④ Delay Time is the duration until alarm rings after detected FHR goes beyond the limit.

⑤ Line Color is US1 and US2 channel. It sets the color of FHR wave which is extracted from input Doppler sound.

⑥ US2 Offset is US2 channel. You can use it when you add offset on FHR wave extracted from input Doppler sound. You can choose offset among 0, 10 and 20.

⑦ To save the settings, select OK.

⑧ Not to save the settings, select Cancel.

[ OK ] [ Cancle ]



2) TOCO/FM SetUp

TOCO/FM CONFIGURATION

TOCO

BASELINE

FM

GRATH

THRESHOLD

LINE COLOR

TOCO

FM1

FM2

DEMO MONITOR NUM.

5

OFF

30%

OFF 1

US1

140

US1

US2 ( + 20 )

140

TOCO + FM

30 (10) 01/JAN/00 00:02:21 123456789 3cm/min

① Turning the knob and select TOCO marking area in monitoring mode. TOCO

Configuration pops up when pressing the knob.

② Select “FM+FMD” in order to display both FM(fetal movement) and FMD(fetal

movement dot);selecting ”FMD” would show FMD parameter only.

③ UA Color sets the color of UA wave.

④ FM Color sets the color of FM wave.

⑤ TOCO Baseline Set sets UA baseline when pressing zero point adjusting button.

Baseline takes one among 0, 5, 10.

⑥ Select “ON” to display demo data, and “OFF” to display real measurements.

⑦ Select the monitor’s own identification number. This number will be used to identify

the monitor within the central monitoring system.

⑧ To save the settings, select OK.

⑨ Not to save the settings, select Cancel.

[ OK ] [ Cancel ]



3) Print /Screen Setup

PRINT CONFIGURATION

SPEED

SPEED

PAPER

GRID

SIZE

CONTRAST

AUTO PERIOD PRINT

REAL TIME

TRACE

CTG

1 CM/MIN

OFF

B5

LOW

20 MIN

00 MIN

ON

US1

140

US1

US2 ( + 20 )

140

TOCO + FM

30 (10) 01/JAN/00 00:02:21 123456789 3cm/min

① Turn the knob select print setting menu in monitoring menu. Press the knob and Print

Configuration pops up.

② By “Speed”, you can control the printing speed in real time printing. It also controls

the speed of FHR wave shown on the screen. It takes one among 1 cm/min, 2

cm/min, 3cm/min which means shows 1 minute data in 1cm, 2cm, 3cm.

③ By “Paper grid”, you can select paper grid printing. If you choose ON, grid is printed

on the paper together with waves.

④ By “Paper size”, you can select paper size. There are two types of paper, A4 and B5.

⑤ By “Paper contrast ”, you can adjust a contrast of waves printed. If you choose 1, it

prints normally and if you select 2, twice as thick as that.

⑥ By “Auto Period Print Real time”, you can stop printing automatically when printing

time is passed. It keeps printing until pressing print button when it is 0.

⑦ By “Auto Period Print Trace”, you can select the amount of data to print when

pressing print button in tracing mode.

⑧ An item to set whether you want to use Cardio-Toco Graph (CTG) analysis function

or not. If you choose ON, Base FHR values will be printed out 10 minutes after you

press print button. If you press print button after 10 minutes, CTG analysis results will

be printed out

⑨ To save the settings, select OK.

⑩ Not to save the settings, select Cancel.

[ OK ] [ Cancle ]



4) Patient ID Setup

① Turn the knob and select patient ID setting menu in monitoring mode. You can set ID by

pressing the knob. Here, icon changes into icon.

② Turn the knob and move to where you want to set figures.

③ Press the knob, turn the knob, select figures and press the knob again.

④ Repeat number 2 and 3, complete ID settings and press the knob when the cursor

locates on icon to return to monitoring mode changing into icon.



5) Time and date Setup

US1

140

US1

US2 ( + 20 )

140

TOCO + FM

30 (10) 01/JAN/00 00:02:21 123456789 3cm/min

① Turn the knob and select Time and Date setting menu in monitoring mode. You can set

time by pressing the knob. Here, icon changes into icon.

② Turn the knob to move to set figures.

③ Press the knob, select figures by turning the knob and press the knob again.

④ Repeat number 2 and 3, complete Time and Date setting and if you press the the knob

when the cursor locates on icon, it returns to monitoring mode changing into

icon again.



6) Screen Brightness Setup

US1

140

US1

US2 ( + 20 )

140

TOCO + FM

30 (10) 01/JAN/00 00:02:21 123456789 3cm/min

① Turn the knob and select icon in monitoring mode. You can adjust the brightness of the screen by pressing the knob.

② You can change the brightness of the screen by turning the knob.

③ Finishing adjustment, press knob to return to monitoring mode.



Chapter 4. CTG Terminology

1) Baseline FHR

Mean FHR rounded to increments of 5 bpm during a 10 minute segment excluding

periodic or episodic changes, periods of marked variability and, segments of baseline that

differ by >25bpm. Duration must be ≥2 minutes.

2) 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

3) 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.



4) 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.



5) 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.



Chapter 5. Trouble Shooting

1) Trouble Shootings and the Solutions

① When the probe comes off the device in running, “US1 off” or “US2 off” or “TOCO off”

pops up with “ding dong” sound. Check the connection of the probe and reconnect it.

② When running out of paper, “Paper Off” pops up with “ding dong” sound. Please open the

printer cover, check how many papers are left, replace paper and close the printer

cover.

2) Maintenance and Cleanness

You can keep FC – 1400 clean in various ways but please try the recommended ways listed

below.

When you used material that is not approved for use on the device, warranty is not valid

even under warranty period.

Notice

Clean the device and check the device and electrode.

When the device is old or damaged, please do not use the device..

Maintain the device and the electrode clean by rubbing the device with an alcohol cloth at

least once a month. Please do not use lacquer, thinner, ethylene, oxide.

Keep the cable away from dirt or filth, cleanse it with a cloth soaked with warm water

(40˚C/104 F) and cleanse it with clinical alcohol once a week.

Please do not soak the probe cable in liquid or cleanser and keep the device and cables

from any types of liquid.

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.



3) Regular Inspection

Like every medical equipment, please take a regular test for FC-1400 for safety. For test

categories, please see the service manual provided by us.



Chapter 6. Specifications

■ Environmental Specifications

Operating Temperature：15°C to 30°C (59°F to 86°F)

Storage Temperature：- 10°C to 60°C (14°F to 140°F)

Operating/Storage Humidity：20% to 95% RH, non-condensing

Operating Altitude：70(700) to 106Kpa(1060mbar)

■ Power Specifications

Use Power Adaptor

Power Adaptor Input 100~240V, 50~60Hz, 1.2A

Power Adaptor output 18V, 2.5A

Power Fail Protection

■ Performance Specifications

Ultrasound

Input signal : Ultrasound Pulsed Doppler

Ultrasound Frequency : 1.0 MHz

Ultrasound Power : <0.87mW/cm2

FHR Detection Method: Auto Correlation

Measurement Range : 50 ~ 210 beats per minutes(BPM)

FHR Accuracy : ±1 bpm over normal FHR range

Ultrasound Sensitivity : 95dB at 150mm

Uterine Activity

Input Source : External Transducer with strain gauge

Frequency Response : DC ~ 0.5 Hz

Reference(Zero) Control : One touch switch

Measurement Range : 0 ~ 99 units



Fetal Movement Measurement

Detection Source : Ultrasound Pulsed Doppler

Recording Method:

① Spike-like waveform denotes relative intensity and duration of Fetal Movement.

② Dot marks when FM intensity exceeds selected threshold.

Physical Characteristic

Dimensions: 296(W) x 305.5(H) x 97.5(D)mm

Weight: Approx. 2.9kg(without Battery)

Display

320x240 STN Color LCD(4.7 inch)

Printer

Print Method : Thermal Array Type

Resolution: 8(vertical)/10(horizontal) dot/mm

Print Speed : 1, 2, 3 cm/min

High Speed print : 50 cm/min

Battery(Option)

Ni-MH Battery

12V, 2600mA

External Link

RS232C : Program Down Load, Central (Option)



Product Warranty

Product Name Fetal monitor

Model Name FC-1400

Approval No.

Approval Date

Serial No.

Warranty period 1 year from date of purchase(2 years in Europe)

Date of purchase

Customer

Hospital :

Address :

Name :

TEL :

Sales Agency

Manufacturer

※ Thank you for purchasing FC-1400.

※ This product is manufactured and passed through strict quality control and thorough

inspection.

※ Compensation standard concerning repair, replacement, refund of the product complies

with consumers protection law noticed by Ministry of Finance and Economy.



Manufactured by - Bionet Co., Ltd :

#1101 11F, E&C Venture Dream Tower, 3 3821, DigitalRo 31Gil, GuroGu, Seoul, 152719, ROK

Tel : +82-2-6300-6418 / Fax : +82-2-6300-6425

Distributor by - GIMA SPA

VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056

E-mail : [email protected]

EC Representative -

MGB Endoskopische Gerate GmbH Berlin

Schwarzschildstr. 6, 12489 Berlin, Germany TEL : +49(30)63927010 / FAX : +49(30)63927011

After Sales Service Center - GIMA SPA

VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056

E-mail : [email protected]

Product name : FC-1400

Rev. 1.2

Documents

FC-1400 Operation Manual FC-1400 OPERATION MANUAL · FC-1400 Operation Manual FC 1400 Operation manual. Rev. 1.2 3 How to reach us … The following are telephone numbers and addresses