Bistos BT-300 User Manual

BT-300

Fetal Monitor

OPERATION MANUAL

BT - 300

Keep this manual for future reference

P/N : 300-ENG-OPM-EUR-R12

BT-300 Operation Manual

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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 12

July 2019

Copyright © Bistos Co., Ltd. 2017. All rights reserved.

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

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019.07

BT-300 Operation Manual

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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
1.4	General Precaution Environment.....................................................................	8
1.5	Definitions of Symbols....................................................................................	9

2. INTRODUCTION ................................................................		10
2.1	General ..........................................................................................................	10
2.2	Brief Device Description ...............................................................................	10
2.3	Intended Use..................................................................................................	10
2.4	Product Features ............................................................................................	10
2.5	Options and Accessories.................................................................................	11

3.	INSTALLATION ..................................................................			12
3.1		Description of the BT-300 Front Panel..........................................................		12
3.2		Description of the Left Panel.........................................................................		13
3.3		Description of the Right Panel.......................................................................		13
3.4		Descriptoin of the Rear Panel ........................................................................		14
3.5		Power On .......................................................................................................		14
3.6		Patient Cables ................................................................................................		14
3.7		Event Marker Cable.......................................................................................		15
4.	BT-300 OPERATION ..........................................................			16
4.1		System Startup...............................................................................................		16
		4.1.1	Configuration Settings.........................................................................	16
		4.1.2	Understanding and Setting Alarms ......................................................	17
		4.1.3 Setting[PintSpeed/FetalMovementPrint/AutoPrint/Dop2Offset/RecordEnlarge].........		18
		4.1.4	Setting Time and Date .........................................................................	19
4.2		BT-300 Monitor Display Screen....................................................................		19
		4.2.1 FHR I&II Frame(Fetal Heart Rate Numeric Frame) ...........................		19
		4.2.2 UC Frame(TOCO Numeric Frame) .....................................................		20
		4.2.3 The error and current operation message display ................................		20
4.3		BT-300 Monitor Controls and Indicators.......................................................		20
5.	RECORDER OPERATION .................................................			21
5.1		Loading Paper................................................................................................		21
5.2		Operation .......................................................................................................		22

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6. MONITRING FETAL HEART RATE ...................................			23
6.1		Electromagnetic Interference.........................................................................	23
6.2		Detail Procedure ............................................................................................	25
7. UTERINE CONTRACTION(UC)............................................			27
7.1		Detail Procedure ............................................................................................	27
8.	EVENT MARKER ...............................................................		29
8.1		Event Marker .................................................................................................	29
9.	CLEANING AND DISINFECTION ......................................		30
9.1		Monitor..........................................................................................................	30
9.2		Transducers....................................................................................................	30
9.3		Belts...............................................................................................................	31
9.4		Contacting components and characteristics...................................................	31
9.5		Description of CidexTM ..................................................................................	31
10.		SPECIFICATIONS ............................................................	32
11. TROUBLESHOOTING AND MAINTENANCE ....................			35
11.1		Self Test .......................................................................................................	35
11.2		Ultrasound Transducer Test .........................................................................	35
11.3		UC(TOCO) Test...........................................................................................	35
11.4		Battery Disposal and Handling ....................................................................	36
11.5		Maintenance.................................................................................................	36
11.6 Disposal of the BT-300 ................................................................................			36
11.7 Request a service for general problems .......................................................			36
12. Manufacturer’s Declaration..............................................			37

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019,07

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Section 1

Safety

1.1Instructions 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 selftest 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.

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1.2Warnings

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.

WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

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WARNING: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

1.3Cautions

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)

CAUTION: The relevant law restricts this device to sale by or on the order of a physician.

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.

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CAUTION: When washing the transducer belts, the water temperature must not exceed 60°C (140°F).

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

Otherwise, the paper can be biased one side.

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 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.

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019,07

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1.4General Precaution on Environment

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

	Avoid placing in an
	area exposed to		Avoid exposure to
	moisture. Do not
			direct sunlight
	touch the equipment
	with wet hand.
	Avoid placing in an
	area where there is a
	high variation of
	temperature.		Avoid in the
	Operating
			vicinity of Electric
	temperature ranges
			heater
	from 10°C to 40°C.
	Operating humidity
	ranges from 5% to
	85%.
	Avoid placing in an		Avoid placing in
	area where there is		an area where
	an excessive humidity		there is an
	rise or ventilation		excessive shock
	problem.		or vibration.
	Avoid placing in an		Avoid dust and
	area where chemicals
			especially metal
	are stored or where
			material into the
	there is in danger of
			equipment.
	gas leakage.
	Do not disjoint or		Power off when
	disassemble the		the equipment is
	equipment.		not fully installed.
	BISTOS Co., Ltd.		Otherwise, the
	does not take		equipment could
	responsibility of it.		be damaged.

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1.5Definitions 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.

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Section 2

Introduction

2.1General

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

Brief Device Description

Product Features

Model Configurations

2.2Brief 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.

2.3Intended 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.

WARNING: BT-350 is not intended for use during defibrillation, electrosurgery, or magnetic resonance imaging (MRI).

2.4Product 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.

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019,07

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2.5Options and Accessories

	Accessory			Name		Description
						Ultrasound Transducer for Measuring
				Doppler Probe		FHR
						(IPX8 : Waterproof)
						Pressure Sensor (Tocotonometer) for
				UC Probe		Measuring Uterine contraction
						(IPX8 : Waterproof)
				Event Marker		Used for a Fetal Movement event
				AST Probe		Acoustic Stimulation
				(Option)		Test Probe
				Z-folded type Paper		Z-folder type thermal Paper
				Probe Belt		Used for Holding Doppler Probe
						and/or UC Probe
				Power Cord		AC Power cord
				Power Adaptor		Adaptor for transform AC Power
						(100-240V ~) to DC 18V(2.8A)
				LI-ION Battery		14.8V, 2600mAh
				Ultrasound Gel		Ultrasound transmission gel
						(Sanipia, ECOSONIC)
				Table 2.1. BT-300	Accessories

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019,07

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Section 3

Installation

3.1Description of the BT-300 Front Panel

Fig. 3.1 BT-300 Front Panel

Power Indicating LED (AC:Green / Battery:Orange)

DOP 1 Connector

DOP 2 Connector(AST Connector)

UC Connector

Event Marker Connector

FHR & UC Value Display Panel

Heartbeat Lamp

DOP 1 Volume Up/Down Button

DOP 2 Volume Up/Down Button

UC Reference Button

Printer On/Off Button

Printer & Alarm LED

Alarm Sound On/Off Button

Print Door Open Button

P/N : 300-ENG-OPM-EUR-R12	Bistos Co.,Ltd.	2019,07