Gima FC-1400 User manual

FC-1400 Operation Manual
FC-1400
OPERATION
MANUAL
Rev. 1.2

FC-1400 Operation Manual
FC 1400 Operation manual. Rev. 1.2
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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

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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 : [e-mail]
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 : [phone]
Service call
VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY
Tel : ++39 02 953854209 Fax : ++39 02 95380056
E-mail : [e-mail]
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 : [e-mail]
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.

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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.

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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 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 10C to
40C. 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.

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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.
(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.

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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

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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

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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.

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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)

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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)

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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

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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.

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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.

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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

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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

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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

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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

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- 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.

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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.