Bionet FC-700 Installation manual

Fetal Monitor FC-700 Operating Manual
FC-700
OPERATION
MANUAL
Fetal Monitor
Operation Manual
Rev 2.41

Rev.2.41 2
Fetal Monitor FC-700 Operating Manual
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.(Two 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.
-
Warning
Federal law restricts this device to sale by or on the order of a
physician

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Fetal Monitor FC-700 Operating Manual
How to reach us …
The following are telephone numbers and addresses for contacting various service, product
supplies and sales personnel
Product and
Purchase
Inquiry
Bionet Co.,Ltd.
Address #1101 11F E&C Venture Dream Tower3 38-21,
Digital-Ro 31-Gil, Guro-gu, Seoul, South Korea (ZIP 152-719)
Overseas sales dept.
Tel:[phone]
Fax : [phone]
E-mail : [e-mail]
URL : http:// www.ebionet.com
※In the event of malfunction or failure, contact us along with the model name, serial number,
and product name of the equipment.
Without prior notice, the specifications and functions are subject to change to enhance
the product in this manual.

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Fetal Monitor FC-700 Operating Manual
Definition of Warning, Prohibition,
Mandatory Action and 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.
Prohibition
To inform that it may cause serious injury or death to the patient,
property damage, material losses against the “warning” sign.
Warning
To inform that it may cause no harm in life but lead to injury against
the “Caution” sign.
Mandatory Action
To inform that it must be proceeded 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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Fetal Monitor FC-700 Operating Manual
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. Bionet
Co.Ltd takes no
responsibility of it
Power off when the
equipment is not fully
installed.
Otherwise, equipment
could be damaged.

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Fetal Monitor FC-700 Operating Manual
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, 1.5A, Output : 18V, 2.8A).
- 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-700. To use same power source with other electric
instruments may cause incorrect result.
Warning statement for class i me equipment indicating: “warning: To avoid risk of electric
shock, this equipment must only be connected.
Warnings regarding significant risks of reciprocal interference posed by me equipment
during specific investigations or treatments.
Note
FC-700 is classified as listed below ;
-This equipment conforms to Class I, 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 configuration shall comply with
the system standard EN 60601-1-1:1993.
If in doubt, consult the technical service department or your local representative.
Note
Please check the below.
-The protective earth connection points connect separated adapter.
-FC700 obtain certification adapter to use, so don’t have to test this equipment.
-This equipment doesn’t have protective earth connection point.
-Authenticated adapter is the equipment that has passed through the protective
earth connection test.
-Protective earth connection test is the equipment itself is replaced by a test of the
certified adapter.
-Therefore, there is no need to test the protective earth connection point with this
equipment.

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Fetal Monitor FC-700 Operating Manual
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
Isolated patient connection. (IEC 601-1-Type BF)
Device part switched off.
Device part switched on.
Equipotential Stud: A ground wire from another device
can be tied here to ensure the devices share a common
reference.
External Signal IN/OUT Port
IPX1
Protection against vertically falling water drops(IEC
60529) Water Protection Specification Level 1
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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Fetal Monitor FC-700 Operating Manual
Table of Contents
Table of Contents ........................................................8
Chapter 1. General Information ................................10
1) Product Overview ........................................................................10
2) Product Features .........................................................................10
3) Product Configuration.................................................................10
4) Explanation of Sections of Output Sheets.................................16
5) CardioTocoGraph(CTG) Analysis output paper area................17
6) Product Installation .....................................................................19
Chapter 2. How to Use FC-700..................................21
1) Basic operation............................................................................21
2) Function of Keys..........................................................................21
3) FHR Measurement .......................................................................22
4) UC Measurement..........................................................................24
5) Measurement of Fetal Movements..............................................25
6) Recording.....................................................................................26
7) FHR Alarm....................................................................................27
8) Volume Control............................................................................27
9) Equipment State Alarm ...............................................................28
Chapter 3. Setup Modes............................................29
1) Alarm/Time Setup ........................................................................29
2) Recording Setup..........................................................................32
3) Factory Setup...............................................................................36
Chapter 4. CTG Terminology ....................................37
1) Baseline FHR................................................................................37
2) ACCELERATION ..........................................................................37
3) LATE DECELERATION ................................................................37
Chapter 5. Trouble shooting.....................................40
1) Maintenance and Cleaning..........................................................40
2) Regular Inspection.......................................................................41

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Fetal Monitor FC-700 Operating Manual
3) Error Message..............................................................................41
Chapter 6. Specifications..........................................42
Appendix A Maintenance, Care, and Service ..........44
Appendix B Ultrasound Power.................................46
Appendix C Abbreviation and Symbol.....................50
Appendix D Electromagnetic Emissions and
Immunity - Manufacturer’s declaration ..................53

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Fetal Monitor FC-700 Operating Manual
Chapter 1. General Information
1) Product Overview
FC-700 is the fetal monitor that measures the fetal heart rate and uterine contraction. FC-700
irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler
frequency signal reflected from the heart of the fetus. FC-700 analyzes this signal and displays
the heart rate by LED. Also, FC-700 provides the sound from the heart of fetus.
FC-700 measures the uterine contraction of a pregnant woman by pressure sensors and
displays the numerical values.
And FC-700 records the heart rate of the fetus, fetal movement and the values of uterine
contraction.
Intended use
FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED,
prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also
provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for
the will being of single fetus.
It intended to be used by trained healthcare personnel. It is not intended for home use.
2) Product Features
-FC-700 records the heart rate of the fetus, fetal movement and the uterine contraction of a
pregnant woman, and basic information of the equipment with wide A4 Size paper.
-FC-700 can use general fax paper as well as thermal paper for fetal monitor.
-FC-700 has automatic NST function which records FHR, UC and fetal movement only for the
established time.
3) Product Configuration
FC-700 system 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.
①FC-700 main body
②Ultrasound Doppler Probe (1 EA)
③UC Probe (1EA)
④Event Mark Jack (1EA)
⑤Print Paper (1EA)
⑥Power Adaptor (1EA)
⑦Power Cord (1EA)
⑧Ultrasound Gel (1EA)
⑨Probe Belt (2EA)
⑩Operation Manual (1EA)

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Fetal Monitor FC-700 Operating Manual
Warning
- Do not reuse the ultrasonic gel.
- Warnings regarding significant risks of reciprocal interference posed
by me equipment during specific investigations or treatments.
- Information on potential electromagnetic or other interference and
advice on how to avoid or minimize such interference.
- A warning statement addressing hazards that can result from
unauthorized modification of me equipment according to following
examples: only can fix the Service person of Bionet.
- Power supply is specified as a part of ME Equipment.
Safety Symbols Marked on the Package
Symbols
Contents
Show a direction of top
Keep dry
fragile
Not to use hook

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Fetal Monitor FC-700 Operating Manual
Main Body configuration
▣Top view
①②③④⑤
①Hand Grip
②Printer door
③Printer door release button
④Display LED
⑤Control panel
①
②

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Fetal Monitor FC-700 Operating Manual
▣Front view
①
①Printer door release button
▣Rear view
○,1○,2○,3
○,4
○,1 Power adaptor connection port
○,2 Power on/off switch
○,3 RS-232C serial port
○,4 Mark Jack connection port
Prohibition
Please instruct the operators to avoid contact with both the RS-232C Serial
port area and the patient simultaneously.
To avoid an expected electric shock, do not open the equipment cover or
disassemble the equipment. Refer servicing to qualified personnel of
Bionet Co., Ltd.
①
②

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Fetal Monitor FC-700 Operating Manual
▣Left side view
①
①Hand Grip
▣Right side view
①
①Doppler, UC Probe connection port
Note
To avoid an expected electric shock, do not open the equipment cover or disassemble the
equipment. Refer servicing to qualified personnel of Bionet Co., Ltd.

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Fetal Monitor FC-700 Operating Manual
▣Control Panel
①②③
④
⑤⑥⑦⑧⑨⑩
①Heart rhythm symbol (Green : stable, Red : unstable).
②Heart rate of the fetus (bpm).
③UC measurement value.
④Volume up/down key. During the use of the Menu for setup, this key is used to
change the setting value.
⑤LED of the alarm on/off
⑥Alarm on/off key. During the use of the Menu for setup, this key is used to set the
function of the time and date.
⑦LED of the power on/off
⑧Print on/off Key. When setup mode, store the setting value. When out of print, paper
feeding function.
⑨LED of the print on/off
⑩Key setting UC value as reference value(10). When setup mode, printing related
functions setup.

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Fetal Monitor FC-700 Operating Manual
4) Explanation of Sections of Output Sheets
①Fetal heart rate per minute
②Fetal movement point that is indicated when Event Marker is pressed
③Uterine contraction
④Information on the recording condition
⑤Fetal movement point when an automatic fetal movement is detected
⑥Recording time
⑦Strength and intervals of automatic fetal movements when they are detected

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Fetal Monitor FC-700 Operating Manual
5) CardioTocoGraph(CTG) Analysis output paper area
(Option)
①②
CTG Analysis results is printed out every 10 minute. (Intermediate Report)
Start printing by pressing print button in order to analyze CTG and repress print button to
stop printing process. CTG analysis results will be printed. (Final Report)
*You have to obtain data at least for 10 minutes
< Intermediate Report >
CTG Period : 0-10 min
BASELINE FHR : 123 bpm
NUMBER of UC : 3
NUMBER of ACC : 0
NUMBER of DEC : 3
LATE DEC : 0
EARLY DEC : 3
VARIABLE DEC : 0
Time during which CTG is analyzed
Mean of Baseline FHR during the period
Number of UC during analysis period
Number of Acceleration during the period
Number of Deceleration during the period
Number of Late DEC during DEC
Number of Early DEC during DEC
Number of Variable DEC during DEC

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Fetal Monitor FC-700 Operating Manual
< Final Report >
-Period : Time during which CTG is analyzed
-Average Baseline FHR(bpm) : Mean number of Baseline FHR during above period
-Number of UC(Frequency / h) : Number of UC and frequency of UC per hour during the
period
-Number of ACC(Frequency/h): : Number of Acceleration and frequency of Acceleration per
hour during the period
-Number of DEC(Frequency /h) : Number of Deceleration and frequency of Deceleration
per hour during the 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
-TACHY : MODERATE(>160bpm) : Time in minute during which FHR is 160~190 bpm
-TACHY : SEVERE(>190bpm) : Time in minute during which FHR 이is greater than 190
bpm
-BRADY : MODERATE(<110bpm) : Time in minute during which FHR is 110~90 bpm
-BRADY: SEVERE (<90bpm) : Time in minute during which FHR is smaller than 90bpm
CTG REPORT (PERIOD : 0 - 15 MIN 0 SEC)
AVERAGE BASELINE FHR(BPM) : 123 bpm
NUMBER OF UC(FREQUENCY) : 5/ 20.0/h
NUMBER OF ACC(FREQUENCY) : 0/ 0.0/h
NUMBER OF DEC(FREQUENCY) : 5/ 20.0/h
LATE DEC : 0
EARLY DEC : 5
VARIABLE DEC : 0
TACHYCARDIA : MODERATE(>160BPM) : 0.0 min
SEVERE(>190BPM) : 0.0 min
BRADYCARDIA : MODERATE(<110BPM) : 0.0 min
SEVERE(<90BPM) : 0.0 min

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Fetal Monitor FC-700 Operating Manual
6) Product Installation
▣Basic Operation
Pay attention to the following in installing FC-700:
①Use it at the temperature between 10 and 40 degrees centigrade and at the humidity
between 30 and 85 percent.
②Check plug-in and treat the Probe Cable carefully.
③Don’t put several plugs in an outlet.
④Install the main body at the flat place.
⑤Avoid using a plug making a noise in plug-in.
⑥All the setup will be recorded at the interior memory even when it is switched off and
then on.
⑦Be careful, as it is easy to break by the shock.
⑧Install it away from dust or inflammable things in consideration of the temperature
and humidity.
▣Power Supply
Use free voltage of AC between 100 and 250V(50-60Hz, 1.2A). If a plug is put in an outlet, the
“POWER”LED at operation panel will be turned on green. Within the equipment is a battery to
change the date and time even when it is switched off. Use a Type CR2032 3V Lithium Battery.
Mandatory Action
Don’t throw away batteries carelessly to protect environment, but ask the
hospital for the designated places to dump batteries according to proper
procedure.
Only, use the FC-700 Adapter please.
▣Plug-in
Put the plug in an outlet of 110V or 220V and connect one side of power cable to the power
adaptor. If you put the plug of power adaptor in the terminal of power adaptor of the main body
of FC-700 and then switch it on, the equipment will work.
If the power supply is normal, LED at the operation panel indicating Power On/Off will be turned
on green.

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Fetal Monitor FC-700 Operating Manual
▣Connection of the Probe Cable
Connect the Probe Cable to the Probe Cable terminal at the right side of the main body.
Connect the Doppler Probe to the “DOP”terminal and the UC Probe to the “UC”terminal.
Connect Mark Jack to the “MARK”terminal at the backside of the main body.
Note
Probe cable must be connected with device power is on.
▣Setting of Recording Paper
If you release the button to open the printer cover at the front of FC-700 to the right, it will open.
Put recording paper with the recording part on the upper side adjusting the paper roll parallel to
the print direction and then close the cover.
Mandatory Action
Only use the FC-700 paper please.
▣Software Version
The information in this manual only applies to FC700 patient monitor software version 3.06 Due
to continuing product innovation, specifications in this manual are subject to change without
notice. You can see from the paper below.