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
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

FC-1400 Operation Manual
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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.

FC-1400 Operation Manual
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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.

FC-1400 Operation Manual
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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)