Bistos BT-300 Manuel utilisateur

OPERATION MANUAL

Keep this manual for future reference

P/N : 300-ENG-OPM-EUR-R09

BT-300

Fetal Monitor

BT-300 Operation Manual 1

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

Proprietary Material

Information and descriptions contained in this manual are the property of

Bistos Co., Ltd. and may not be copied, reproduced, disseminated, or

distributed without express written permission from Bistos Co. , Ltd.

Information furnished by Bistos Co., Ltd. is believed to be accurate and

reliable. However, no responsibility is assumed by Bistos Co., Ltd. for its

use, or any infringements of patents or other rights of third parties that may

result from its use. No license is granted by implication or otherwise under

any patent or patent rights of Bistos Co., Ltd.

Revision 09

Mar,2018

7th FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu,

Seongnam-si, Gyeonggi-do, Korea

Telephone: ++82 31 750 0340

Fax: ++82 31 750 0344

Printed in Korea

BT-300 Operation Manual 2

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

Table of Contents

1. SAFETY ..............................................................................4

1.1 Instructions for the Safe Operation and Use of the BT-300 Monitor............... 4

1.2 Warnings.......................................................................................................... 5

1.3 Cautions........................................................................................................... 5

1.4General Precaution Environment..................................................................... 7

1.5Definitions of Symbols.................................................................................... 8

2. INTRODUCTION ..................................................................9

2.1 General ............................................................................................................ 9

2.2 Brief Device Description................................................................................. 9

2.3 Intended Use.................................................................................................... 9

2.4 Product Features.............................................................................................. 9

2.5 Options and Accessories................................................................................ 10

3. INSTALLATION..................................................................11

3.1 Description of the BT-300 Front Panel...........................................................11

3.2Description of the Left Panel......................................................................... 12

3.3Description of the Right Panel....................................................................... 12

3.4Descriptoin of the Rear Panel........................................................................ 13

3.5Power On....................................................................................................... 13

3.6Patient Cables ................................................................................................ 13

3.7Event Marker Cable....................................................................................... 14

4. BT-300 OPERATION..........................................................15

4.1 System Startup............................................................................................... 15

4.1.1 Configuration Settings......................................................................... 15

4.1.2 Understanding and Setting Alarms ...................................................... 17

4.1.3 Setting[PintSpeed/FetalMovementPrint/AutoPrint/Dop2Offset/RecordEnlarge]......... 17

4.1.4 Setting Time and Date ......................................................................... 18

4.2 BT-300 Monitor Display Screen.................................................................... 18

4.2.1 FHR I&II Frame(Fetal Heart Rate Numeric Frame) ........................... 19

4.2.2 UC Frame(TOCO Numeric Frame)..................................................... 19

4.2.3 The error and current operation message display ................................ 19

4.3 BT-300 Monitor Controls and Indicators....................................................... 19

5. RECORDER OPERATION .................................................20

5.1 Loading Paper................................................................................................ 20

5.2 Operation....................................................................................................... 21

BT-300 Operation Manual 3

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

6. MONITRING FETAL HEART RATE ...................................22

6.1 Electromagnetic Interference......................................................................... 22

6.2 Detail Procedure............................................................................................ 24

7. UTERINE CONTRACTION(UC)............................................26

7.1 Detail Procedure............................................................................................ 27

8. EVENT MARKER...............................................................28

8.1 Event Marker................................................................................................. 28

9. CLEANING AND DISINFECTION ......................................29

9.1 Monitor.......................................................................................................... 29

9.2 Transducers.................................................................................................... 29

9.3 Belts............................................................................................................... 30

9.4 Contacting components and characteristics................................................... 30

9.5 Description of CidexTM.................................................................................. 30

10. SPECIFICATIONS............................................................31

11. TROUBLESHOOTING AND MAINTENANCE....................34

11.1 Self Test ....................................................................................................... 34

11.2 Ultrasound Transducer Test ......................................................................... 34

11.3 UC(TOCO) Test........................................................................................... 34

11.4 Battery Disposal and Handling.................................................................... 35

11.5 Maintenance................................................................................................. 35

11.6 Disposal of the BT-300................................................................................ 35

11.7 Request a service for general problems ....................................................... 35

12. Manufacturer’s Declaration.............................................. 36

BT-300 Operation Manual 4

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

Section 1

Safety

1.1 Instructions for the Safe Operation and Use of the

BT-300 Monitor

Examine the monitor and any accessories periodically to ensure that

the cables, line cords, transducers, and instruments do not have visible

evidence of damage that may affect patient safety or monitoring

performance. The recommended inspection interval is once per week

or less. Do not use the monitor if there is any visible sign of damage.

Only the AC line cord supplied with the BT-300, or its equivalent, is

approved for use with the Unit.

Do not attempt to service the BT-300 monitor. Only qualified service

personnel by Bistos Co., Ltd. should attempt any needed internal

servicing.

The BT-300 is not specified or intended for operation during the use of

defibrillators or during defibrillator discharge.

The BT-300 is not specified or intended for operation in the presence

of electrosurgical equipment.

The BT-300 is not specified or intended for operation in conjunction

with any other type of monitoring equipment except the specific

devices that have been identified for use in this Operator’s Manual.

Perform periodic safety testing to insure proper patient safety. This

should include leakage current measurement and insulation testing.

The recommended testing interval is once per year.

Do not operate the BT-300 monitor if it fails to pass the power on self-

test procedure.

WARNING: Be informed that it may cause serious injury or death to the

patient, property damage, and 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.

BT-300 Operation Manual 5

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

1.2 Warnings

1.3 Cautions

WARNING: EXPLOSION HAZARD — Do not use the BT-300 in a

flammable atmosphere where concentrations of flammable anesthetics or

other materials may occur.

WARNING: SHOCK HAZARD — The power receptacle must be a three

wire grounded outlet. Never adapt the three-prong plug to fit a two-slot

outlet. If the outlet has only two slots, make sure that it is replaced with a

three-slot grounded outlet before attempting to operate the monitor.

WARNING: Do not connect to an electrical outlet controlled by a wall

switch.

WARNING: SHOCK HAZARD — Do not attempt to connect or

disconnect a power cord with wet hands. Make certain that your hands are

clean and dry before touching a power cord.

WARNING: Use only patient cables and transducers supplied with the

monitor. Use of any other patient cables may result in out-of-specification

performance, possible safety hazards and electromagnetic safety problems.

WARNING: Do not contact RS-232C port and patient at the same time.

WARNING: AC/DC Adaptor should use appointed product.

WARNING: SHOCK HAZARD — Do not attempt to disjoint the power

adaptor exterior with no permission. It may cause electric shock. Also it

has low possibility of reaching to death. In the case of you have some

problems with the power adaptor, we recommend that you have to contact

to us first of all.

WARNING: SHOCK HAZARD — Do not touch the patient

simultaneously with contacting signal connector, other equipment or

ground. This can cause the electric shock to the patient or operator.

WARNING: SHOCK HAZARD — During upgrading the BT-300, do not

use the BT-300 to the patient. This can cause the electric shock to the

patient.

CAUTION: The relevant law restricts this device to sale by or on the order

of a physician.

CAUTION:

-The equipment conforms to Class A 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)

BT-300 Operation Manual 6

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Bistos Co.,Ltd.

2018,03

CAUTION: Keep the operating environment free of dust, vibrations,

corrosive, or flammable materials, and extremes of temperature and

humidity. The unit should be kept clean and free of transducer gel and

other substances.

CAUTION: When installing the unit into a sealed place, allow for

adequate ventilation, accessibility for servicing, and room for adequate

visualization and operation. Two side of the device is must be opened.

CAUTION: Do not operate the unit if it is damp or wet because of

condensation or spills. Avoid using the equipment immediately after

moving it from a cold environment to a warm, humid location.

CAUTION: Never use sharp or pointed objects to operate the front-panel

switches.

CAUTION:

General-purpose personal computers and modems are not

designed to meet the electrical safety requirements of medical devices. The

RS-232C connector on the BT-300 is electrically isolated to permit safe

connections to non-medical devices, which should be connected with a cable

of sufficient length to prevent the non-medical equipment from contacting the

patient. If the BT-300 have to be connected another medical devices, it must

be complied with the standards IEC/EN 60601-1 and IEC/EN 60601-1-2.

CAUTION:

Do not autoclave or gas sterilize the monitor or any accessories.

Follow cleaning and disinfection instructions in Section 9 of this manual.

CAUTION:

Do not immerse BT-300 main body and transducers in liquid. When

using solutions, use sterile wipes to avoid pouring fluids directly on the transducer.

Follow cleaning and disinfection instructions in Section 9 of this manual.

CAUTION: When washing the transducer belts, the water temperature

must not exceed 60°C (140°F).

CAUTION: If the equipment use in area where the integrity of the

external protective conductor in the installation or its arrangement is in

doubt, equipment shall be operated from its internal electrical source when

the optional battery is selected.

CAUTION: When loading paper, the paper must be put above the shaft.

Otherwise, the paper can be biased one side.

CAUTION: When the printer door is open, do not put the finger to the

inside of BT-300. This can cause the finger wound. Also do not prick the

inside of BT-300 when the printer door is open. This can cause the

damage to the device or electric shock.

CAUTION: Portable or mobile RF communication equipments can affect

BT-300. Please turn off these equipments when BT-300 is used.

BT-300 Operation Manual 7

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

1.4 General Precaution on Environment

Do not keep or operate the equipment under the environment listed below.

Avoid placing in an

area exposed to

moisture. 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 5% 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.

BISTOS Co., Ltd.

does not take

responsibility of it.

Power off when

the equipment is

not fully installed.

Otherwise, the

equipment could

be damaged.

BT-300 Operation Manual 8

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

1.5 Definitions and Symbols

Symbol

Description

Power On/Off Button

This symbol identifies a safety note. Ensure you understand the

function of this control before using it.

There are no noted or identified hazards by ultrasound. But there

is unknown hazardous possibility by ultrasound.

External Signal IN/OUT Port

Type BF Equipment

IPX8 IPX8 Waterproof

(1 meter of water for 40 minutes.)

Operating instructions

When disposing of some components (ex: internal Li-ion

battery), do not dispose as general wastes.

Adhere to all applicable laws regarding recycling.

※According to IEC 60601-1-6 General requirements for basic safety and essential

performance – Collateral Standard : Usability, the definition and using these symbols

is adjusted.

BT-300 Operation Manual 9

P/N : 300-ENG-OPM-EUR-R09

Bistos Co.,Ltd.

2018,03

Section 2

Introduction

2.1 General

This chapter provides a general description of the BT-300 monitor including:

Brief Device Description

Product Features

Model Configurations

2.2 Brief Device Description

The BT-300 is a microprocessor-based fetal monitor, providing continuous

monitoring, display, and recording of fetal heart rate (FHR) and uterine

contraction (UC) for antepartum testing and monitoring.

2.3 Intended Use

The BT-300 is a Prenatal Monitoring System for non-invasively measuring and

showing graphically maternal abdominal contractions and the fetal heart rate by

means of display on a non-permanent graphical display and on a strip chart

recorder. This data is intended to aid in assessing the well-being of the fetus

during the final trimester of pregnancy (Non-Stress Test). This device is for use

only by trained medical personnel located in hospitals, clinics, doctor’s offices

and in the patient’s home.

2.4 Product Features

The monitored data can be recorded continuously or intermittently on a strip

chart recorder at the operator’s discretion. The recorded information includes

graphic trend data and text information of monitor hardware and software

configuration, date and time, patient identification, changes to operational

settings, clinician and patient event marks.

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