FC-700 Operating Manual Rev 2.51

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.

Rev. 2.51

2

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

Purchase Inquiry

GIMA SPA Via Marconi, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : export@gimaitaly.com

Manufacturer

Bionet Co., Ltd. #1101 11F E&C Venture Dream Tower3 38-21, Digital-Ro 31-Gil, GURO-GU, SEOUL, SOUTH KOREA (ZIP 08376) Overseas sales dept. Tel : +82-70-7585-6418 E-mail : sales@ebionet.com

Service call

VIA Marconi, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : export@gimaitaly.com

Technical support

Per questioni tecniche o problemi con il dispostivo, contattare: Via Marconi, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : export@gimaitaly.com

Web site

URL : http://www.gimaitaly.com URL : http://www.bio2net.com

In the event of malfunction or failure, contact us along with the model name, serial number, and product name of the equipment.

Rev. 2.51

3

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 Per informare che si deve procedere per il funzionamento e manutenzione sicuri dell' apparecchiatura.

NOTE To inform that it is not dangerous but important “note” sign for proper installation, operation, and maintenance of the equipment.

Rev. 2.51

4

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.

Rev. 2.51

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.

5

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. • FC-700 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.

Rev. 2.51

6

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.

Rev. 2.51

7

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) Installazione del prodotto

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

35

Rev. 2.51

8

FETAL MONITOR FC-700 OPERATING MANUAL

Chapter 4. CTG Terminology

36

1) Baseline FHR

36

2) Acceleration

36

3) Late Deceleration

36

Chapter 5. Trouble shooting

39

1) Maintenance and Cleaning

39

2) Regular Inspection

40

3) Error Message

40

Chapter 6. Specifications

41

Appendix A Maintenance, Care, and Service

43

Appendix B Ultrasound Power

45

Appendix C Abbreviation and Symbol

48

Appendix D Electromagnetic Emissions and Immunity - Manufacturer’s declaration

49

Rev. 2.51

9

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. 1. FC-700 main body 2. Ultrasound Doppler Probe (1 EA) 3. UC Probe (1EA) 4. Event Mark Jack (1EA) 5. Print Paper (1EA) 6. Power Adaptor (1EA) 7. Power Cord (1EA) 8. Ultrasound Gel (1EA) 9. Probe Belt (2EA) 10. Operation Manual (1EA)

Rev. 2.51

10

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 GIMA SPA. 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.

Rev. 2.51

11

FETAL MONITOR FC-700 OPERATING MANUAL

Main Body configuration Top view

4 1 5

2

3

1. Hand Grip. 2. Printer door. 3. Printer door release button. 4. Display LED. 5. Control panel.

Rev. 2.51

12

FETAL MONITOR FC-700 OPERATING MANUAL

Front view

1

1. Printer 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 GIMA SPA.

Rev. 2.51

13

FETAL MONITOR FC-700 OPERATING MANUAL

Left side view

1

1. Hand Grip.

Right side view

1

1. Doppler 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 GIMA SPA.

Rev. 2.51

14

FETAL MONITOR FC-700 OPERATING MANUAL

Control Panel 2

3

1

10

4

5

6

7

8

9

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

Rev. 2.51

15

FETAL MONITOR FC-700 OPERATING MANUAL

4) Explanation of Sections of Output Sheets

1. Fetal heart rate per minute. 2. Fetal movement point that is indicated when Event Marker is pressed. 3. Uterine contraction. 4. Information on the recording condition. 5. Fetal movement point when an automatic fetal movement is detected. 6. Recording time. 7. Strength and intervals of automatic fetal movements when they are detected.

Rev. 2.51

16

FETAL MONITOR FC-700 OPERATING MANUAL

5) CardioTocoGraph(CTG) Analysis output paper area (Option)

1

2

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

Time during which CTG is analyzed

BASELINE FHR

: 123 bpm

Mean of Baseline FHR during the period

NUMBER of UC

:3

Number of UC during analysis period

NUMBER of ACC

:0

Number of Acceleration during the period

NUMBER of DEC

:3

Number of Deceleration during the period

LATE DEC

:0

Number of Late DEC during DEC

EARLY DEC

:3

Number of Early DEC during DEC

VARIABLE DEC

:0

Number of Variable DEC during DEC

Rev. 2.51

17

FETAL MONITOR FC-700 OPERATING MANUAL < Final Report > CTG REPORT (PERIOD : 0 - 15 MIN 0 SEC) AVERAGE BASELINE FHR(BPM) NUMBER OF UC(FREQUENCY) NUMBER OF ACC(FREQUENCY) NUMBER OF DEC(FREQUENCY) LATE DEC EARLY DEC VARIABLE DEC TACHYCARDIA : MODERATE(>160BPM) SEVERE(>190BPM) BRADYCARDIA : MODERATE(<110BPM) SEVERE(<90BPM)

• • • • • • • • • • • •

: 123 bpm : 5/ 20.0/h : 0/ 0.0/h : 5/ 20.0/h :0 :5 :0 : 0.0 min : 0.0 min : 0.0 min : 0.0 min

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 is 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

Rev. 2.51

18

FETAL MONITOR FC-700 OPERATING MANUAL

6) Product Installation Basic Operation Pay attention to the following in installing FC-700: • Use it at the temperature between 10 and 40 degrees centigrade and at the humidity between 30 and 85 percent. • Check plug-in and treat the Probe Cable carefully. • Don’t put several plugs in an outlet. • Install the main body at the flat place. • Avoid using a plug making a noise in plug-in. • All the setup will be recorded at the interior memory even when it is switched off and then on. • Be careful, as it is easy to break by the shock. • Install 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.

Rev. 2.51

19

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.

Rev. 2.51

20